IMAGING

SIGMA 110/SIGMA 330

Operator Manual
(Software Version V 5.XX)

© Copyright by KONTRON MEDICAL, 2001

Ref.: DOC31001EN Issue date: 10.12.01 Issue: 4

 GENERAL INFORMATION

15.10.01 GENERAL INFORMATION i

ii SIGMA 110/SIGMA 330 15.10.01
I. Copyright
© 2001 by KONTRON MEDICAL SAS
ALL RIGHTS RESERVED
PRINTED IN FRANCE

The information contained in this publication may not be used for any purpose other than that for
which it was originally supplied. The publication may not be reproduced in part or in whole with-
out written consent of KONTRON MEDICAL SAS. In order to maintain and improve standards of
manufacturing, methods of functioning and reliability, KONTRON MEDICAL SAS equipments are
periodically reviewed. For this reason, the content of this publication is subject to change without
any notice.

This product contains KONTRON MEDICAL’ proprietary software in machine-readable form.

KONTRON MEDICAL SAS retains all its rights, title and interest in the software. Purchase of this
product includes a license to use the software contained in it. The purchaser shall not copy, trace,
disassemble or modify the software, nor cause or allow this software to be copied, traced, disas-
sembled or modified. Transfer of this product by the purchaser will constitute a transfer of this
license, which will not be transferable otherwise.

The equipment described is manufactured by:

KONTRON MEDICAL S.A.S.

Boite Postale 97
78373 PLAISIR CEDEX
FRANCE

Internet: www.kontronmedical.com

Apple, Macintosh, iMac, MacOS, FireWire are registered trademarks of Apple Computer, Inc.
Intel®, Pentium® and Pentium III® are registered trademarks of Intel Corporation.
Linux is a registered trademark of Linus Torvalds.
Matrox® is a registered trademark of Matrox Electronic Systems Ltd.
Microsoft® and Windows® are registered trademarks of Microsoft Corporation.
USB is a registered trademark of USB Implementers Forum, Inc.
SonoWin®, SonoWinlite® and SonoWinbasic® are registered trademarks of Meso.

15.10.01 GENERAL INFORMATION iii

II. Quality, Reliability and Safety
This equipment has been designed with high standards of quality, reliability and safety. KON-
TRON MEDICAL SAS can however only accept the corresponding manufacturer’s responsibility
providing the following conditions are met: Electrical installations of the room or building in which
the equipment is to be used must comply with the relevant national regulations. The equipment is
used in accordance with the instructions for use provided by KONTRON MEDICAL SAS (Opera-
tor manual). All modifications and repairs to the equipment are carried out by authorized KON-
TRON MEDICAL personnel, or their agents. The equipment must comply with regulations
specified in the "Safety Informations" section.

Your local KONTRON MEDICAL company or agent is: (To be filled by local KONTRON MEDICAL
company or agent.)

iv SIGMA 110/SIGMA 330 15.10.01

 TABLE OF CONTENTS

10.12.01 v
vi SIGMA 110/SIGMA 330 10.12.01
I. Copyright ..........................................................................................iii
II. Quality, Reliability and Safety.......................................................... iv
III. Intended Clinical Use and Safety Information ................................ xv
IV. Compliance with Standards...........................................................xxx

1. INSTRUMENT DESCRIPTION .....................................................1-1

1.1 Introduction.............................................................................................................. 1-3
1.2 SIGMA 110/330 Equipments ................................................................................... 1-5
1.3 Physical Description ................................................................................................ 1-7
1.3.1 Electronic Cabinet...................................................................................... 1-11
1.3.2 Control Panel ............................................................................................. 1-11
1.3.3 TV Monitor ................................................................................................. 1-15
1.3.4 Front Panel ................................................................................................ 1-17
1.3.5 Rear Panel ................................................................................................. 1-22
1.4 System Controls .................................................................................................... 1-28
1.4.1 Alphanumeric Keys .................................................................................... 1-28
1.4.2 Live Investigation Keys .............................................................................. 1-29
1.4.3 Keys for Frozen Image Study..................................................................... 1-30
1.4.4 Trackball..................................................................................................... 1-31
1.5 Screen Layout ....................................................................................................... 1-33
1.5.1 Ultrasound Screen Layout ......................................................................... 1-33
1.5.2 Menu.......................................................................................................... 1-36
1.5.3 Technical Data Area................................................................................... 1-38
1.6 Display Modes ....................................................................................................... 1-42
1.6.1 2D Modes .................................................................................................. 1-42
1.6.2 TM Modes.................................................................................................. 1-42
1.6.3 CW and PW Modes ................................................................................... 1-43
1.6.4 CFM Formats............................................................................................. 1-43
1.7 SIGMA 110 Technical Specifications..................................................................... 1-44
1.7.1 General ...................................................................................................... 1-44
1.7.2 2D (B-Mode) .............................................................................................. 1-46
1.7.3 TM (M-Mode) ............................................................................................. 1-46
1.7.4 Spectral Doppler Mode .............................................................................. 1-47
1.7.5 Digital Archiving: KIPRISM ........................................................................ 1-48
1.7.6 ECG Module (option) ................................................................................. 1-48
1.7.7 EasyPrintTM .............................................................................................. 1-49
1.7.8 USB-LinkTM .............................................................................................. 1-49
1.7.9 Peripherals (Optional) ................................................................................ 1-49
1.7.10 Inputs/Outputs ........................................................................................... 1-49
1.7.11 Measurement............................................................................................. 1-49
1.7.12 Acoustic Power .......................................................................................... 1-51
1.7.13 Environment............................................................................................... 1-51
1.7.14 Regulation and Safety ............................................................................... 1-51

10.12.01 TABLE OF CONTENTS vii

 1.7.15 Dimensions ................................................................................................1-52
1.8 SIGMA 330 Technical Specifications ..................................................................... 1-53
1.8.1 General ...................................................................................................... 1-53
1.8.2 2D (B-Mode)...............................................................................................1-55
1.8.3 TM (M-Mode) .............................................................................................1-56
1.8.4 Spectral Doppler Mode ..............................................................................1-56
1.8.5 Colour Doppler Modes ...............................................................................1-58
1.8.6 3D Imaging................................................................................................. 1-58
1.8.7 Digital Archiving: KIPRISM.........................................................................1-59
1.8.8 ECG Module (option) .................................................................................1-59
1.8.9 EasyPrintTM...............................................................................................1-59
1.8.10 USB-LinkTM...............................................................................................1-59
1.8.11 Peripherals (Optional) ................................................................................1-60
1.8.12 Inputs/Outputs............................................................................................1-60
1.8.13 Measurement .............................................................................................1-60
1.8.14 Acoustic Power...........................................................................................1-61
1.8.15 Environment ...............................................................................................1-62
1.8.16 Regulation and Safety ................................................................................1-62
1.8.17 Dimensions ................................................................................................1-62

2. INSTALLATION ............................................................................. 2-1

2.1 Installation Requirements ........................................................................................2-3
2.2 Unpacking ................................................................................................................2-3
2.2.1 Warning........................................................................................................ 2-3
2.2.2 Unpacking the Instrument ............................................................................ 2-3
2.3 Checking the Instruments Identification ...................................................................2-3
2.4 Checking the Delivery ..............................................................................................2-4
2.5 Transport ...............................................................................................................2-6
2.6 Installation of SIGMA 330 Expert and SIGMA 330 Excellence................................2-7
2.6.1 Installation of the integrated cart ..................................................................2-7
2.6.2 Installation of the flat panel monitor .............................................................2-8
2.6.3 Installation of the integrated compact PC (SIGMA 330 Excellence only).....2-8
2.7 Power Source Connection .....................................................................................2-10
2.7.1 Input Power Source ....................................................................................2-10
2.7.2 Output Power Source .................................................................................2-11
2.8 Connecting a Probe ...............................................................................................2-12
2.8.1 SIGMA 330 Expert and SIGMA 330 Excellence Probe Assignment..........2-12
2.8.2 SIGMA 110 Light/Master and SIGMA 330 Master Probe Assignment .......2-13
2.8.3 Probe Connection ......................................................................................2-13
2.9 Connection of Peripherals......................................................................................2-15
2.9.1 Electrical safety with peripherals ................................................................2-15
2.9.2 Recommended Peripherals........................................................................2-17
2.9.3 Archiving on Personal Computer................................................................2-17
2.9.4 Connection of B&W Video Printer ..............................................................2-18
2.9.5 Connection of Colour Video Printer............................................................ 2-19

viii SIGMA 110/SIGMA 330 10.12.01

 2.9.6 Video Recorder (VCR)............................................................................... 2-20
2.9.7 ECG Module .............................................................................................. 2-22
2.9.8 Colour Monitors ......................................................................................... 2-23
2.9.9 Black & White Monitor ............................................................................... 2-25
2.9.10 Printer ........................................................................................................ 2-26
2.9.11 Connection with medical grade isolators ................................................... 2-32
2.9.12 Connection with S-Video Distributor .......................................................... 2-33

3. OPERATING INSTRUCTIONS......................................................3-1
3.1 Operating Precautions............................................................................................. 3-3
3.2 Switching the Instrument ON................................................................................... 3-4
3.2.1 Switching ON SIGMA 110 and SIGMA 330 Master..................................... 3-4
3.2.2 Switching ON SIGMA 330 Expert................................................................ 3-4
3.2.3 Switching SIGMA 330 Excellence ON ......................................................... 3-4
3.2.4 Initialization of SIGMA ................................................................................. 3-5
3.3 Switching the Instrument OFF ................................................................................. 3-6
3.3.1 Switching OFF SIGMA 110 and SIGMA 330 ............................................... 3-6
3.3.2 Switching OFF SIGMA 330 Excellence ....................................................... 3-6
3.4 Menus...................................................................................................................... 3-7
3.4.1 Notes ........................................................................................................... 3-7
3.4.2 Menu Key Conventions ................................................................................ 3-7
3.4.3 Menu Types ................................................................................................. 3-7
3.4.4 Menu Display ............................................................................................... 3-7
3.4.5 Menu Items .................................................................................................. 3-8
3.5 Probes ................................................................................................................... 3-11
3.5.1 Probe Selection ......................................................................................... 3-11
3.5.2 Menu Display ............................................................................................. 3-11
3.6 Setup .................................................................................................................... 3-13
3.6.1 Setup Menu ............................................................................................... 3-13
3.6.2 Loading a Setup......................................................................................... 3-13
3.6.3 Saving a Setup .......................................................................................... 3-13
3.6.4 Deleting a Setup ........................................................................................ 3-14
3.6.5 Preferences ............................................................................................... 3-14
3.6.6 PCMCIA CARD.......................................................................................... 3-23
3.6.7 System Info................................................................................................ 3-23
3.7 Major Modes.......................................................................................................... 3-25
3.7.1 2D Mode .................................................................................................... 3-25
3.7.2 TM (Time Motion) ...................................................................................... 3-31
3.7.3 PW Doppler ............................................................................................... 3-34
3.7.4 CW Doppler ............................................................................................... 3-39
3.7.5 CFM Mode ................................................................................................. 3-42
3.7.6 3D imaging................................................................................................. 3-46
3.8 Print ....................................................................................................................... 3-47
3.9 Cine Mode ............................................................................................................. 3-48
3.9.1 Storing Pictures ......................................................................................... 3-48

10.12.01 TABLE OF CONTENTS ix

 3.9.2 Displaying Pictures.....................................................................................3-49
3.9.3 Cine Auto-Replay .......................................................................................3-49
3.10 Magnifier in 2D and CFM Mode .............................................................................3-50
3.11 Digital Archiving: KIPRISM ....................................................................................3-51
3.11.1 Image Storage and Freeze Menu...............................................................3-51
3.11.2 Archive: Display of Stored Images .............................................................3-52
3.11.3 Using the Memory Card on PC ..................................................................3-54
3.11.4 Patient Report and Patient ID with KIPRISM .............................................3-55
3.12 Annotations ............................................................................................................3-59
3.12.1 Entering Annotation Mode.......................................................................... 3-59
3.12.2 Exiting the Annotation Mode ......................................................................3-59
3.12.3 Manual Text Annotation..............................................................................3-60
3.12.4 Labels.........................................................................................................3-60
3.12.5 Arrows ........................................................................................................3-64
3.13 Body Markers.........................................................................................................3-65
3.13.1 Displaying Body markers............................................................................3-65
3.13.2 Moving Body Markers.................................................................................3-66
3.13.3 Deleting Body markers ...............................................................................3-66
3.13.4 Medical.......................................................................................................3-66
3.13.5 Deleting All Annotations .............................................................................3-66
3.14 Measurements .......................................................................................................3-67
3.14.1 Generalities ................................................................................................3-67
3.14.2 Starting a Measurement.............................................................................3-68
3.14.3 2D Measurement........................................................................................ 3-68
3.14.4 CFM Measurement ....................................................................................3-75
3.14.5 TM Measurement .......................................................................................3-77
3.14.6 Doppler Measurement................................................................................3-82
3.15 Biometry and Report..............................................................................................3-90
3.15.1 Biometry Pictograms ..................................................................................3-90
3.15.2 Patient Information .....................................................................................3-90
3.15.3 Biometry Patient Study...............................................................................3-90
3.15.4 Report ........................................................................................................3-91
3.15.5 Starting a Study..........................................................................................3-91
3.15.6 Radiology Study .........................................................................................3-92
3.15.7 Obstetrics/Gynaecology Study ...................................................................3-93
3.15.8 Vascular Study ...........................................................................................3-94
3.15.9 Cardiology Study ........................................................................................ 3-94
3.16 ECG (Option) .........................................................................................................3-95
3.17 EasyPrint™ Options...............................................................................................3-96
3.17.1 Printing of images ......................................................................................3-96
3.17.2 Printing of Report .......................................................................................3-98
3.18 USB-Link™ Option................................................................................................. 3-99
3.18.1 Overview ....................................................................................................3-99
3.18.2 Compatibility...............................................................................................3-99
3.18.3 Usage example with Windows® 2000........................................................3-99
3.18.4 Read data from a computer .....................................................................3-101

x SIGMA 110/SIGMA 330 10.12.01

 3.18.5 Copy data to the computer ...................................................................... 3-101
3.18.6 Interface with PACS ................................................................................. 3-102
3.18.7 Limitations................................................................................................ 3-102
3.19 SonoWin® Lite and SonoWin® Basic PACS ....................................................... 3-103
3.19.1 Overview.................................................................................................. 3-103
3.19.2 Start a Study............................................................................................ 3-104
3.19.3 Save images, reports and patient information ......................................... 3-105
3.19.4 Transfer data to SonoWin®...................................................................... 3-106
3.19.5 Data Assignment ..................................................................................... 3-109
3.20 Integrated PC (SIGMA 330 Excellence) .............................................................. 3-110
3.20.1 Overview.................................................................................................. 3-110
3.20.2 SAFETY PRECAUTIONS ........................................................................ 3-110
3.20.3 Entering PC remote control mode ........................................................... 3-111
3.20.4 PC remote control features description ................................................... 3-111
3.20.5 Leaving PC remote control mode ............................................................ 3-111
3.20.6 Keyboard in PC mode.............................................................................. 3-111
3.20.7 Errors and warnings................................................................................. 3-114
3.20.8 PC power on ............................................................................................ 3-114
3.20.9 PC power off ............................................................................................ 3-114
3.20.10 3D VascularView™ and 3D FetalView™ ................................................. 3-115
3.20.11 PACS option............................................................................................. 3-115
3.20.12 Connection to a Network ......................................................................... 3-115
3.20.13 Installation of peripherals......................................................................... 3-115

4. MAINTENANCE ............................................................................4-1
4.1 Cleaning .................................................................................................................. 4-3
4.1.1 Probes ......................................................................................................... 4-3
4.1.2 TV Monitor ................................................................................................... 4-3
4.1.3 EYE-Q 300M Monitor................................................................................... 4-3
4.1.4 Keyboard...................................................................................................... 4-3
4.1.5 Instrument.................................................................................................... 4-4
4.2 Disinfection .............................................................................................................. 4-5
4.3 Repairs and Maintenance........................................................................................ 4-8
4.3.1 User Maintenance........................................................................................ 4-8
4.3.2 Manufacturer Maintenance .......................................................................... 4-9
4.4 Product Recycling and Disposal............................................................................ 4-10

5. TROUBLESHOOTING ..................................................................5-1
5.1 Handle Error and Warning Messages ..................................................................... 5-3
5.2 Introduction and Rules............................................................................................. 5-4
5.2.1 Rules............................................................................................................ 5-4
5.2.2 Definition...................................................................................................... 5-4
5.2.3 Remarks ...................................................................................................... 5-4
5.3 Status Messages ..................................................................................................... 5-5

10.12.01 TABLE OF CONTENTS xi

 5.3.1 ECG .............................................................................................................5-5
5.3.2 Measurement and Biometry .........................................................................5-7
5.3.3 Transmit Voltage Indicator ............................................................................ 5-8
5.4 Warnings ..................................................................................................................5-9
5.4.1 Start-up checks ............................................................................................5-9
5.4.2 System Configuration Check......................................................................5-10
5.4.3 Flash card and SRAM ................................................................................5-11
5.4.4 Miscellaneous checks ................................................................................5-13
5.5 General Failures and Errors................................................................................... 5-18
5.5.1 Error 0: Internal unexpected interrupt ........................................................5-18
5.5.2 Error 1: Can not restore backed up configuration ......................................5-18
5.5.3 Error 2: Tracking problem - Fatal error ....................................................... 5-19
5.5.4 Error 3: Memory allocation error - Fatal error.............................................5-19
5.5.5 Error 4: Divide by 0 - Fatal error .................................................................5-19
5.5.6 Error 5: Communication error..................................................................... 5-19
5.5.7 Error 6: Flash card read error..................................................................... 5-19
5.5.8 Error 7: Flash card write error ....................................................................5-19
5.5.9 Error 8: Invalid flash card type....................................................................5-20
5.5.10 Error 9: Ob/Gyn restore error ..................................................................... 5-20
5.5.11 Error 10: Flashcard not correctly formatted................................................5-20
5.5.12 Error 11: Internal Communication - Fatal error...........................................5-20
5.5.13 Error 12: Cannot program TMPAVG ...........................................................5-20
5.5.14 Error 13: CFM Frame Filter LUT Error ....................................................... 5-21
5.5.15 Error 14: CFM Function LUT Error .............................................................5-21
5.5.16 Error 15: CFM LUT programming time out error ........................................5-21
5.5.17 Error 16: Flashcard removed while printing................................................5-21
5.5.18 Error 17: Internal communication - Fatal error ...........................................5-21

6. OPTIONS AND ACCESSORIES .................................................. 6-1

6.1 Options.....................................................................................................................6-3
6.2 List of Probes ...........................................................................................................6-4
6.3 Accessories..............................................................................................................6-5

7. APPENDICES............................................................................... 7-1
Appendix A: Overview .................................................................. 7-3
A.1 Entering the Biometry ......................................................................................7-3
A.2 Exiting the Biometry .........................................................................................7-3
A.3 Make a Measurement from Report ..................................................................7-3
A.4 Importing Measurements in Report .................................................................7-4
Appendix B: Report Menu............................................................. 7-5
Appendix C: Patient Information ................................................... 7-7
C.1 First Page ........................................................................................................ 7-7
C.2 Second Page ................................................................................................... 7-9

xii SIGMA 110/SIGMA 330 10.12.01

 Appendix D: Cardiology Study.....................................................7-11
D.1 Left Ventricle Study ....................................................................................... 7-12
D.2 Mitral Valve Study ......................................................................................... 7-18
D.3 Aortic Valve Study ......................................................................................... 7-22
D.4 Right Ventricle Study .................................................................................... 7-26
Appendix E: Vascular Study........................................................7-31
E.1 Description .................................................................................................... 7-31
E.2 Stenosis Percentage ..................................................................................... 7-31
E.3 Equations ...................................................................................................... 7-33
Appendix F: Ob/Gyn Studies.......................................................7-37
F.1 2D Sheet ....................................................................................................... 7-37
F.2 TM/SP Sheet ................................................................................................. 7-41
F.3 Foetal Information Sheet ............................................................................... 7-43
F.4 Setup Sheet .................................................................................................. 7-44
F.5 User Table Sheet .......................................................................................... 7-47
F.6 Curve View .................................................................................................... 7-48
Appendix G: Reference Tables for Ob/Gyn .................................7-49
G.1 Biparietal Diameter (BPD) ............................................................................. 7-49
G.2 Chorion Diameter (ChD) from Rempen ........................................................ 7-57
G.3 Femur Length (FML) ..................................................................................... 7-58
G.4 Humerus Length (HuL) ................................................................................. 7-65
G.5 Transabdominal Diameter (TAD) from Merz ................................................. 7-67
G.6 Thoracic Diameter (THD) from Hansmann .................................................. 7-68
G.7 Anterior Posterior Diameter (APD) ................................................................ 7-69
G.8 Crown Rump Length (CRL) .......................................................................... 7-71
G.9 Gestational Sac (GES) .................................................................................. 7-76
G.10 Abdominal Circumference (AC) .................................................................... 7-78
G.11 Head Circumference (HC) ............................................................................ 7-81
G.12 Binocular Distance (BOD) from Jeanty ......................................................... 7-84
G.13 Occipital Frontal Diameter (OFD) from Merz ................................................ 7-84
Appendix H: Radiology Study......................................................7-85
H.1 Description .................................................................................................... 7-85
H.2 Equations ...................................................................................................... 7-86
Appendix I: Measurement Interface ...........................................7-89
I.1 Doing a Measurement from Report ............................................................... 7-89
I.2 Importing Measurements in Report ............................................................... 7-91
Appendix J: Print Preview........................................................... 7-93
J.1 Edit the Printable Report ............................................................................... 7-93

10.12.01 TABLE OF CONTENTS xiii

 J.2 Print the Report on an External Printer ..........................................................7-94
J.3 Save the Report on a Flashcard ....................................................................7-94
Appendix K: KIPRISM / SonoWin® Basic Conversion Tables.... 7-95
K.1 Overview ........................................................................................................7-95
K.2 Cardiology Measurements .............................................................................7-95
K.3 Vascular measurements ..............................................................................7-102
K.4 Obstetric and Gynaecology .........................................................................7-104
K.5 Radiology Study ..........................................................................................7-108
K.6 Multiple associations ...................................................................................7-109
Appendix L: Body Markers ....................................................... 7-111
L.1 Vascular .......................................................................................................7-111
L.2 Radiology .....................................................................................................7-111
L.3 Obstetrics/ Gynaecology .............................................................................7-112
L.4 Cardiology ...................................................................................................7-112
Appendix M: Acoustic Output Tables ........................................ 7-113
M.1 Track3 Summary Tables .............................................................................7-113
M.2 Definition of Terms ...................................................................................... 7-114
M.3 Acoustic Output Tables ...............................................................................7-116

xiv SIGMA 110/SIGMA 330 10.12.01

III. Intended Clinical Use and Safety
Information

This system complies with the Medical Device Directive (MDD) 93/42/EEC, according to which
KONTRON MEDICAL has classified this device as a Class 1 Type B device.

Note for U.S. Customers

U.S Federal Law restricts this device to sale, distribution and use by or on the order of a
physician.

III.1 .Intended Clinical Use

The SIGMA 110 / 330 is intended for visualization by ultrasound of internal organs, for medical
diagnostic purposes only. It must be operated by qualified and trained Physician or "Sonogra-
pher".

The particular organs visualized, and the methods of visualization, depend on the particular
transducer used, and the imaging mode employed.
“Modes” are used in two senses in this manual: “Imaging Modes” refer to the method of depicting
the organs visualized, and are explained below. It is also used to indicate various operational
modes, such as “freeze,” “zoom,” “cine”, etc. In general, it is obvious when a non-imaging mode
is referred to. In the manual they are explained when they are first used.

The principal imaging modes of the SIGMA 110/330 and their abbreviations, which are used
throughout this manual, are as follows:

2D: Two-dimensional representation of a “slice” in the body, often called “B-mode.”

TM: Often called just “M-Mode,” the ultrasound beam is stationary (giving an A-scan), but the
time axis moves, with the result that moving organs can be easily visualized.
PW: Pulse Wave Doppler, which permits determining the velocity of blood or another organ in the
interior of the body.
CW: Continuous Wave Doppler, which determines the velocity of flow or movement of all ele-
ments within the range of the probe.
CFM: Colour-flow mapping, which superimposes a map of the velocity of moving organs or blood
on top of a 2D scan (B-scan) of the organs.

The SIGMA 110/330 does not permit “composite” modes (two modes produced at the same
time). However, two modes can be made sequentially and then displayed next to each other on
the same screen. If two modes are displayed together, this is called a “double-pad” mode. If only
one is displayed, it is called a “single-pad” mode.

15.10.01 GENERAL INFORMATION xv

These are all real-time displays. However, an image can be “frozen” at a particular point in time
to produce a static display so that it may be studied in more detail later.
Imaging modes are explained in more detail in Chapter 3.7, “Major Modes”, on page 3-25

The following table lists the SIGMA 110 / 330 probes and their intended clinical use:

Nominal Frequency PROBE

PROBE TYPE MODES
(MHz) APPLICATIONS
Convex Linear Probes
3.5 MHz CV 3.5 Abdominal, Ob/Gyn 2D/TM/PW/CFM
Cardiology, Transcranial 2D/TM/PW/CFM
3.5 MHz MC 3.5 Abdominal,
Vascular/Angiology
Pediatrics, Cardiology, 2D/TM/PW/CFM
6.5 MHz MC 6.5
Vascular/Angiology
Linear Probes
Abdominal, Obstetrics, 2D/TM/PW/CFM
5.0 MHz LV 5
Pediatrics, Perivascular
Pediatrics, Perivascular, 2D/TM/PW/CFM
7.5 MHz LV 7.5
Small Parts
Pediatrics, Perivascular, 2D/TM/PW/CFM
7.5 MHz LVS 7.5
Small Parts
Endocavitarian Probes
6.5 MHz EV 6.5 Ob/Gyn, Urology 2D/TM/PW
Endorectal multiplane for 2D/TM/PW
6.5 MHz MR 6.5
Urology
6.5 MHz VMC 6.5 Ob/Gyn, Urology 2D/TM/PW/CFM
Annular Sector Probes
Cardiology, Abdominal, 2D/TM/PW/CW
3.5 MHz GP 3.5
Ob/Gyn
Abdominal, Ob/Gyn 2D/TM/PW/CW
5.0 MHz GP 5.0
Cardiology, Pediatrics
Vascular, Small parts, 2D/TM/PW/CW
7.5 MHz GP 7.5
Neonatology
Perivascular, Small Parts, 2D/TM/PW
14 MHz PV 14
Breast, Muskuloskeletal
Pencil Probes
PEN 2 MHz 2 Cardiovascular PW/CW
PEN 4 MHz 4 Vascular PW/CW
PEN 8 MHz 8 Vascular PW/CW
TCD 2 MHZ 2 Transcranial Doppler PW

Table i: Probe applications

Details on the various applications are below.

xvi SIGMA 110/SIGMA 330 15.10.01

Abdominal / Gynaecology / Urology Application
The probe applies ultrasound energy through the patient abdomen to obtain an image of the
abdominal organs to detect abnormalities (imaging) and assess the blood velocity, flow and pat-
ency of abdominal vessels through the Doppler modalities.

Perivascular Application
The probe applies ultrasound energy through the neck or extremities of a patient to obtain an
image of the carotid artery, or other peripheral vessels, that can be used to detect abnormalities
or obstructions in the vessel. In Doppler modes, the probe applies ultrasound energy through the
neck or extremities of a patient to assess the blood velocity, flow or lack of flow and patency of
peripheral vessels.

Small Parts Application

The probe applies ultrasound energy through the skin to obtain an image or a Doppler flow visu-
alization of small organs such as the thyroid (neck), testicles (scrotal sac) and breast.

Cardiology Application
The probe applies ultrasound energy through the chest wall to obtain an image of the heart for
purpose of assessing cardiac abnormalities. In Doppler modes, the probe applies energy through
the chest wall to determine the velocity and direction of blood in the heart and in the vessels.

Obstetrics / Fetal Application

The probe applies ultrasound energy through a pregnant woman‘s abdomen to obtain an image
of the fetus to detect structural abnormalities or to visualize and measure anatomical and physio-
logical parameters of the fetus for the purpose of assessing fetal growth. In Doppler modes, the
probe applies energy through the patient abdomen to detect placental or fetal flow abnormalities.

Note
The user should always follow the ALARA (As Low As Reasonably Achievable) principle,
but especially in Obstetrics / Fetal applications. Use the lowest amount of acoustic output
power for the shortest duration of time to obtain the necessary clinical diagnostic informa-
tion.

Neonatology Application
The probe applies ultrasound energy through the neonatal head fontanelles to visualize brain
structures (imaging) or flow (Doppler) to detect structural or functional abnormalities.

WARNING: This system is not to be used for transorbital or any other ophtalmic applica-
tions.

Transcranial Doppler
The probe applies ultrasound energy through the adult patient skull to, visualize flow (Pulsed
Wave Doppler) to detect functional abnormalities.

15.10.01 GENERAL INFORMATION xvii

WARNING: This system is not to be used for transorbital or any other ophtalmic applica-
tions.
The main features of the probes are shown in the table below:

Frequency
Focal
PROBE Range
Scanning Point Resolution Ceramics
TYPE (FL to FH
(mm)
in MHz)
Angle Width lateral axial d LxW
(degree) (mm) (mm) (mm) (mm) (mm)
Convex
3.5 MHz CV 2-5 45 - 60 - 70 1.2 0.7 - 86.4 x 12
3.5 MHz MC 2-5 30 - 90 - 70 1.5 0.7 - 38.2 x 11
6.5 MHz MC 4-9 30 - 90 - 45 0.6 0.4 - 33.4 x 6.5
Linear
5.0 MHz LV 3-7 - 63 50 1.0 0.5 - 86.4 x 11
7.5 MHz LV 4 - 10 - 50 20 0.6 0.3 - 59.4 x 4.5
7.5 MHz LVS 4 - 12 - 38 25 0.5 0.3 - 38.4 x 6.5
Endocavitarian
6.5 MHz EV 4-9 90 - 140 - 25 0.7 0.4 9 -
6.5 MHz MR 4-9 90 - 110 - 25 0.7 0.4 8 -
6.5 MHz VMC 4-9 45 - 111 - 45 0.6 0.4 - 33.4 x 6.5
Annular Sector
3.5 MHz GP 2-5 45 - 90 - 70 1.6 0.8 16 -
5.0 MHz GP 3-7 45 - 90 - 40 0.8 0.5 11.4 -
7.5 MHz GP 5 - 10 40 - 90 - 20 0.4 0.3 7 -
14 MHz PV 8 - 16 40 - 15 0.3 0.2 5.5 -
Pencil
TCD 2 MHZ 2 - - 45 3 - 15 -
PEN 2 MHz 2 - - 45 3 - 13 -
PEN 4 MHz 4 - - 30 2 - 9 -
PEN 8 MHz 8 - - 20 2 - 6 -

Table ii: Probe Features

III.2.Safety Information
In this manual a WARNING pertains to possible injury to a patient and/or the sonographer. A
CAUTION describes the precaution which are necessary to protect the equipment.
Be sure that you understand and observe each of cautions and warnings.

xviii SIGMA 110/SIGMA 330 15.10.01

III.2.1 . Electrical Safety
As defined in EN60601-1 (IEC Standard 601-1, safety of Medical Electrical Equipment), this
equipment is classified as Class I, type B (probes), while the ECG module has a Class CF
degree of protection.
WARNINGS
• The system must be properly grounded to prevent shock hazards. Protection is provided by
grounding the chassis with a three wire cable and plug; the system must also be powered
through a properly grounded receptacle.
• Electrical shock hazard. Do not remove any panel. Refer servicing and internal adjustments
to qualified KONTRON personnel only.
• For continued protection against risk of fire, replace fuses only with fuses of the same type
and rating (see Chapter 2.7, “Power Source Connection”, on page 2-10).
• The equipment is not suitable for use in the presence of a flammable anaesthetic mixture with
air, oxygen or nitrous oxide. Do not use the system in the presence of flammable anaesthet-
ics. Explosion is a hazard under such conditions.
• The system not watertight and provides a class IP(X)0 degree of protection to liquids; do not
expose the system to rain or moisture. Avoid placing liquid containers on the system.
• Remove probes and electrocardiography leads from patient contact before applying a high
voltage defibrillation pulse.
• Like any other ultrasound equipment, the SIGMA 110/330 uses high frequency signals which
could interfere with pacemakers. You should be aware of this small potential hazard and
immediately turn off the unit if interference in the pacemaker operation is noted or suspected.
• If you drop or strike a probe, do not use it until a measurement of the electrical leakage cur-
rent has demonstrated that a electrical safety has not been compromised. It is also necessary
to insure that the probe has not been cracked or damaged so that it produces erroneous
scans.
• Do not immerse the entire probe in liquids to clean it. The probe is not watertight and immer-
sion may compromise the electrical safety features of the probe. Carefully follow the cleaning
instructions in this manual.
• Take all appropriate precautions to avoid impact damage to the sensitive face of the probe.
• The use of products not approved by KONTRON MEDICAL such as oil, Methylene blue, ether
or some disinfectants could cause permanent damage to the sensitive part of the transducer.
Only the KONTRON MEDICAL supplied gel (KONTRON supply part number 100 250, ultra-
sonic gel) is recommended by KONTRON MEDICAL for coupling the transducer to the skin.
The use of an agent other than the approved gel may adversely affect the quality of the
images and produce substandard results.
• The cart available with the SIGMA 330 Expert and SIGMA 330 Excellence provides insulated
plugs and connectors to manage optional hard copy devices (VCR, printers). Follow the
instructions in this manual to install such a device. Wrong connections may compromise the
electrical safety of the system.
• Never connect additional peripherals directly to wall outlets; use a medical grade isolating
transformer which must comply with IEC 601-1 specifications. Wrong connections may com-
promise the electrical safety of the system.
KONTRON MEDICAL provides a medical grade isolating transformer and isolating accesso-
ries on request, see Chapter 6.3, “Accessories”, on page 6-5 for ordering.

15.10.01 GENERAL INFORMATION xix

 • Never connect Network (RJ-45) directly to the system; use a medical grade network isolator
which must comply with IEC 601-1 specifications. Wrong connections may compromise the
electrical safety of the system.
KONTRON MEDICAL provides a medical grade isolator on request, see Chapter 6.3, “Acces-
sories”, on page 6-5 for ordering.
CAUTIONS
• In order to prevent an overheating, ensure that the ventilation openings are not covered and
keep the SIGMA 110/330 rear panel away from a vertical wall.
• To prevent further damage to your system and the accessories, power off the unit if it does not
start up correctly.
• Never expose the probes to gas, heat or unauthorized liquid sterilization procedures (see
probe cleaning instructions). These methods can permanently damage the probe.
• Do not connect or disconnect an active probe during live scanning; the system must be in
freeze mode or turned off to connect or disconnect a probe.
• Carefully follow the Operator‘s Manual instructions to clean or disinfect a probe.
Safety Symbols
The International Electrotechnical Commission (IEC) has defined a set of graphic symbols for
use on medical electronic equipment. The following symbols are used on KONTRON MEDICAL’
systems:

ON (Power)

OFF (Power)

AC line input

Protective earth (ground)

Equalization potential terminal

Type CF isolated E.C.G input, defibrillator proof (IEC 601 - 1)

Type B equipment (IEC 601 - 1)

This symbol generally means "Attention". Please consult the equip-

ment documentation carefully before using any function labelled
with this symbol

xx SIGMA 110/SIGMA 330 15.10.01

III.2.2. Environmental Safety
Electro-Magnetic Compatibility
This system complies with the EN60601-1-2 (Electro-Magnetic Compatibility). It is a Class B
device.
Ultrasound units are designed to receive radio frequency (RF) energy and are, therefore, sus-
ceptible to other RF sources. As an example, other medical devices, information technology
products or TV/Radio transmitters may all cause interference with the ultrasound system.
In the presence of RF interference, the physician must evaluate the image degradation and its
diagnostic impact.
• Electrostatic discharge (ESD)
An electrostatic discharge is a short transient current flow. It may happen if electrostatically
charged people touches a part of ultrasound system. ESD may causes white or black dots in
2D or TM mode, coloured dots in CFM and can be heard or seen as dots in Doppler mode.
The effects created by ESD are not at all correlated with the ultrasound information. There-
fore, they may be well differentiated from the true ultrasound echo.
• Burst
Bursts are short transient pulses on the mains power line. They may cause white or black
dots in 2D or TM mode, coloured dots in CFM and can be heard or seen as dots in Doppler
mode. The effects created by bursts are not correlated with the ultrasound information. There-
fore, they may be well distinguishable from the true ultrasound echo.
• Immunity restriction
Electromagnetic fields in the environment of the ultrasound system may cause white or black
patterns in 2D or TM mode, coloured patterns in CFM and can be seen as horizontal lines in
Doppler mode. Especially in the Doppler modes (CW and PW), some lack of immunity may
be observed in a narrow frequency band of 20 kHz at the used frequency and its multiples.
Typically, the transducer acts like the reception antenna and the effects are stronger when it is
applied to patient. In any case, the effects are not correlated with the ultrasound information;
therefore, they may be well distinguishable from the true ultrasound echo.

Electro-Surgical Units (ESUs)

Electro surgical units or other devices that introduce radio frequency electromagnetic fields or
currents into the patient, may interfere with the ultrasound image. An electro surgical device in
use during ultrasound imaging will greatly distort the 2D image and render Doppler modalities
useless.

Information about Reusing/Recycling

In this system, the packing materials are reusable and recyclable; the unit casings (plastic) and
most of the cart components (plastic) are also recyclable.

The SIGMA 110 and SIGMA 330 contains electronic boards, batteries and tubes. Before you dis-
pose the system, these boards, batteries and tubes must be removed and discarded according
to local regulations or recycled where facilities exist. Contact your local KONTRON MEDICAL
company or agent for further informations.
For battery disposal contact your local waste disposal facility.

15.10.01 GENERAL INFORMATION xxi

III.2.3. Biocompatibility and Infection Control
Items in contact with patient
The probe and electrode materials that are in contact with patients, comply with the European
applicable requirements (EN10993). No negative reactions to these materials have been
reported.

Note
KONTRON probes and electrodes do NOT contain Latex.

Infection Control
Since probes and electrodes are intended to be used on intact skin, the use of this system has a
very limited probability of being able to propagate infections; basic procedures as described later
in this manual are sufficient for infection control.

III.2.4. Ultrasound Safety

Introduction
KONTRON MEDICAL has adopted the more recent requirements and recommendations estab-
lished by the USA Food and Drug Administration and by the American Institute for Ultrasound in
Medicine. The SIGMA 110/330 therefore, equipped with the Acoustic Output Display feature to
provide the user with real-time, on-line information on the actual power of the system.

The following sections describe the rationale of this methodology. KONTRON MEDICAL recom-
mends the use of the ALARA principle (see below), which is extensively covered in this manual.

Additionally to this operator manual you get the AIUM manual "Medical Ultrasound Safety" which
covers the following topics more in detail: Bioeffects and biophysics, prudent use and implement-
ing ALARA. Read it carefully before using the SIGMA 110/330.

Clinical Safety
In the USA, in more than three decades of use, there has been no report of injury to patients or
operators from medical ultrasound equipment.

American Institute for Ultrasound in Medicine (AIUM)

Statement on Clinical Safety: October 1 982, Revised March 1 993 and October 1 993

Diagnostic ultrasound has been in use for over 25 years. Given its known benefits and rec-
ognized efficacy for medical diagnosis, including use during human pregnancy, the Ameri-
can Institute of Ultrasound in Medicine herein addresses the clinical safety of such use:

No confirmed biological effects on patients or instrument operators caused by exposure at

intensifies typical of present diagnostic ultrasound instruments have been reported.
Although the possibility exists that such biological effects may be identified in the future,
current data indicate that the benefits to patients deriving from the prudent use of diagnostic
ultrasound outweigh the risks, if any, that may be present.

xxii SIGMA 110/SIGMA 330 15.10.01

The ALARA (As Low As Reasonably Achievable) principle is the guideline for prudent use; dur-
ing an exam, the user should use for the shortest duration the least amount of acoustic output to
obtain the necessary clinical information for diagnostic purposes.

Ultrasound Bioeffects
Although diagnostic ultrasound has an excellent history of safety, it has been known for a long
time that ultrasound, at certain levels, can alter biological systems.
The AIUM Bioeffects Committee describes two fundamental mechanisms by which ultrasound
may induce biological effects: non-thermal or mechanical mechanisms and thermal effects.

Non-thermal bioeffects, also, referred to as mechanical bioeffects, seem to be caused by the

alternate expansion and contraction of tissue induced when ultrasound pressure waves pass
through or near gas. The majority of these non-thermal interactions, also known as cavitation,
deal with the generation, growth, vibration and possible collapse of micro bubbles within the tis-
sue. The occurrence of cavitation depends on a number of factors, such as the ultrasonic pres-
sure and frequency, the ultrasonic field (focused or unfocused, pulsed or continuous), the nature
and state of the tissue and boundaries. Mechanical bioeffects are a threshold phenomenon,
occurring only when a certain level of output is exceeded. However, the threshold level varies
depending on the tissue. The potential for mechanical effects is thought to increase as peak rar-
efactional pressure increases, but decrease as the ultrasound frequency increases.

Although there have been no adverse mechanical bioeffects in humans from diagnostic ultra-
sound exposure, it is not possible to specify thresholds at which cavitation will occur in mammals.

Thermal Bioeffects are the rise in temperature of tissue when exposed to acoustic energy. The
acoustic energy is absorbed by body tissue; absorption is the conversion of this energy into heat.
If the rate of energy deposition in a particular region exceeds the ability to dissipate the heat, the
local temperature will rise. The rise in temperature will depend on the amount of energy, the vol-
ume of exposure, and the thermal characteristics of the tissue.
On-Screen Real-Time Acoustic Output Display
Until recently, application-specific output limits established by the USA Food and Drug Adminis-
tration (FDA) and the user‘s knowledge of equipment controls and patient body characteristics
have been the means of minimizing exposure. Now, more information is available through a new
feature, named the Acoustic Output Display. The Output Display provides users with information
that can be specifically applied to ALARA. It eliminates some of the guess work and provides
both an indication of what may actually be happening within the patient (i.e. the potential for bio-
effects), and what occurs when system control settings are changed. This makes it possible for
the user to get the best image possible while following the ALARA principle and thus to maximize
the benefits/risks ratio.

The SIGMA 110/330 incorporates a real-time acoustic output display according to the AIUM/
NEMA “Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on
Diagnostic Ultrasound Equipment” publication, adopted in 1992 by both institutions. This Output
Display Standard is intended to provide on-screen display of these two indices, which are related
to ultrasound thermal and cavitation mechanisms, to assist the user in making informed risk (i.e.
patient exposure) / benefit (diagnostically useful information) decisions. Considering the type of

15.10.01 GENERAL INFORMATION xxiii

exam, patient conditions and the case study level of difficulty, the system operator decides how
much acoustic output to apply for obtaining diagnostically useful information for the patient; the
thermal and mechanical indices real-time display is intended to provide information to the system
operator throughout the examination so that exposure of the patient to ultrasound can be reason-
ably minimized while maximizing diagnostic information.

For systems with an Output Display, the FDA currently regulates only the maximum output. The
SIGMA 110/330 has been designed to automatically default to the proper range of intensity lev-
els for a particular application. However, within the SIGMA 110/330 limits, the user may override
the application specific limits, if clinically required. The user is responsible for being aware of the
output level that is being used. The SIGMA 110/330 real-time output display provides the user
with relative information about the intensity level.

The Mechanical Index

The Mechanical Index (MI) is defined as the Peak Rarefactional Pressure in MPa (derated by a
tissue attenuation coefficient of 0.3 dB/cm/MHz) divided by the square root of the probe central
frequency in MHz.

With the MI, the user can keep the potential for mechanical bioeffects as low as reasonably
achievable while obtaining diagnostically adequate images. The higher the index, the larger the
potential. However, there is no level that indicates when Bioeffects is actually occurring: The
Index is not intended to give an “alarm” but are an aid in implementing the ALARA principle.

The Thermal Index

The purpose of the Thermal Index (TI) is to keep the user aware of conditions that may lead to a
temperature rise under certain defined assumptions. It is the ratio between the total acoustic
power to the power required to raise tissue temperature by 1°C, estimated on Thermal Models.
There are currently three Thermal Indices (each based on a specific Thermal Model) used to
estimate temperature rise whether at the surface, within the tissues, or at the point where the
ultrasound is focusing on bone:

1. The Soft Tissue Thermal Index (TIS) provides information on temperature increase within soft
homogeneous tissue.
2. The Cranial Bone Thermal Index (TIC) indicates temperature increase of bone at or near the
surface, as may occur during a cranial exam.
3. The Bone Thermal Index (TIB) provides information on temperature increase of bone at or
near the focus after the beam has passed through soft tissue.

As with the Mechanical Index, the Thermal Indices are relative indicator of temperature rise: a
higher value represents a higher temperature rise; they indicate that the possibility for an
increase in temperature exists and they provide a relative magnitude that can be used to imple-
ment ALARA.

The SIGMA 1 1 0/330 Acoustic Output Display

xxiv SIGMA 110/SIGMA 330 15.10.01

The SIGMA 110/330 displays the Acoustic Output Indices during live scanning to the right of the
screen, together with the transmit power setting and other technical data. The following abbrevi-
ations are used:
Index Abbreviation
Mechanical Index MI
Soft Tissue Thermal Index TIS
Cranial Bone Thermal Index TIC
Bone Thermal Index TIB

The Output Display is organized to provide meaningful information to implement ALARA without
“distracting” the user with unnecessary data. Each time a user selects a new probe a choice of
applications is provided (Radio, Vasc., Ob/Gyn, Cardio); depending on the selection, the system
will default the appropriate indices.

Note

Index values below 0.4 are displayed by this system as <0.4. Indices are displayed in 0.2
increments

To optimize ALARA, index values equal or higher than 0.4 are displayed even if the maxi-
mal index value does not exceed 1.0.

The SIGMA 110/330 does not provide combination modes (i.e. modes used simultaneously,
such as real-time 2D and Doppler), but can display a tracing (Doppler or TM-Mode) with a
reference 2D (frozen or periodically updated). The index for the active mode is indicated.

The SIGMA 1 1 0/330 Output Default Settings

System default settings depend upon the probe, the mode of operation and the application which
is selected after selecting a probe. The SIGMA 110/330 defaults the transmit power to obtain out-
put levels that are below the historic Ispta limits established by the FDA for the selected applica-
tion.

Methodology and Accuracy of Display

The displayed indices values must be interpreted as relative information to help the user to
achieve the ALARA principle.

Initial data are derived from laboratory measurements based on the AIUM standard. Then the
indices are calculated beginning from these measurements according to the AIUM/NEMA
“Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diag-
nostic Ultrasound Equipment” publication. Many of the assumptions used for measurements and
calculation are conservative in nature. The measured water tank values are derated using the
conservative attenuation coefficient established by the FDA (0.3 dB/cm/MHz). Over-estimation of
actual In-Situ exposures is thus part of the calculation process.

A number of factors influence the estimation of the accuracy of the displayed indices, the most
significant ones being the variability between probes and the laboratory measurements accuracy

15.10.01 GENERAL INFORMATION xxv

(hydro phone, operator, algorithms, etc.) itself, while variability of the system pulser and effi-
ciency is a minor contributor.

The accuracy of the measurement of the centre frequency is estimated to be ±2%, of the acous-
tic pressure to be ±16%, of the acoustic power to be ±10% and of the acoustic intensity to be
±32%.

The accuracy estimate, based on the variability range of probes and systems, and on the inher-
ent modelling and the above mentioned measurements errors, ranges from ±30% for the MI
index to ±50% for the TI index.

The SIGMA 1 1 0/330 Maximum Acoustic Output

As per the AIUM standard, the tables in Appendix M: Acoustic Output Tables list the maximum TI
(Thermal Index) and MI (Mechanical Index) values for each probe and mode of operation.

The system screens display the recently adopted MI, which is now considered a better relative
indicator of non-thermal bioeffect mechanisms. The SIGMA 110/330 maximal MI is 1.9 which
FDA has recognized as equivalent to pre-amendments Isppa limits.

The SIGMA 110/330 maximum output for Ispta is limited to the preamendments FDA limit for
peripheral vascular applications, which is 720 mW/cm2.

The maximum output for a given probe can be less than the system limit, since the maximum
depends on a variety of elements (crystal efficiency, mode of operation etc.). It is normally
reached with the Vasc. setup, at minimum depth or maximum PRF and in CFM with the smallest
CFM window size.
All terms are defined in Section III.2.6, “Glossary and definition of terms,” on page xxviii
The SIGMA 1 1 0/330 Acoustic Output Controls
Control features may be divided into three categories:

1. controls which directly affect the intensity (direct controls)

2. controls which indirectly affect the intensity (indirect controls)
3. controls which do not affect the intensity, such as the gains and the processing curves.

Controls which directly affect the intensity:

• the Application selection, which establishes the appropriate range of intensities (see Maxi-
mum Output Section)
• the Energy control for Doppler modes, which allows to increase or decrease the output inten-
sity within the range of the selected application.

Controls which indirectly affect the intensity:

This category includes controls which change several aspects of the transmitted ultrasonic field
rather than the intensity. Intensity is affected because of the field variations. Each mode has its

xxvi SIGMA 110/SIGMA 330 15.10.01

own pulse repetition frequency (PRF) and intensity level; moreover, for each mode, a number of
parameters will indirectly affect the transmitted field.

2D
The SIGMA 110/330 allows the user to set the transmit focal point which will affect the indices by
varying the beam profile. Generally, higher MI‘s will occur with farer focal points. If more than one
transmit focal point is activated, MI values will correspond to the zone with the largest value.
TM
In TM mode, the transmitted field is only affected by the transmit focal point and the frequency. If
M-Mode is displayed with a 2D and the 2D is updated, the system may shows always the index
for the active mode (MI for 2D, TI for TM mode)

CFM
The TI may be increased by any control which increases the system frame rate:
• reducing the CFM window size
• increasing the CFM PRF

Another variable factor is the CFM frequency; the outcome in terms of transmitted field is mar-
ginal and largely unpredictable.

Pulsed Wave Doppler

In PW, the transmit energy is adjusted automatically when changing gatesize or PRF to be con-
stant. Therefore the TI is constant for all settings of gatesize and PRF. The only “variable” factor
is the Doppler frequency; the outcome in terms of transmitted field is marginal and largely unpre-
dictable.

Continuous Wave Doppler

In CW, the only “variable” factor is the Doppler frequency. Most probes provide Doppler at more
than one frequency; the outcome in terms of transmitted field is marginal and largely unpredicta-
ble. The user can vary the spectral velocity range; this does NOT, however, change the system‘s
PRF.

Implementing ALARA with the SIGMA 1 1 0/330

Prudent use implies that during an exam the user should use for the shortest time the least
amount of acoustic output to obtain the necessary clinical information for diagnostic purposes. In
other words, your goal is to keep the TI and the MI indices as low as possible for the shortest
time while obtaining the necessary clinical information.

This section does not cover the patient and technique factors which may influence the indices
such as the patient body size, the tissue perfusion characteristics, the presence or the absence
of fluid, etc.
• select the appropriate application when you select the probe

15.10.01 GENERAL INFORMATION xxvii

 • depending on the patient characteristics and the type of exam (see Intended Use Section)
select the appropriate probe and frequency
• use the system capabilities to preset the SIGMA 110/330 to default each mode according to
your needs or specific applications; this will reduce the need for real-time interactions and
help you obtain useful images quickly thus reducing ultrasound exposure
• start scanning with a low output level and optimize the focusing, the gains and all other sys-
tem adjustments; if this is not adequate for diagnostic purposes, then increase the output
level
• use the Output Display feature to guide your settings; remember that the indices do not con-
sider TIME exposure: the higher your indices, the shorter should be the patient exposure

Which index when

In cardiology, vascular and general purpose (abdominal, small parts) exams MI is the primary
concern in 2D mode, while TIS is the principle index in CFM and Doppler.

In Ob/Gyn the TIB should be considered when scanning a second or third trimester fetus, while
the TIS is more reliable for earlier exams.

The TIB is a better predictor during neonatal head studies, while the TIC is more significant in
adult transcranial studies.

III.2.5. Measurement Accuracy on SIGMA 1 1 0/330

This is thoroughly discussed in Chapter 1.7.11 on page 1-49 and Chapter 1.8.13 on page 1-60.

III.2.6. Glossary and definition of terms

ÞIn Situß intensities calculations
When determining the possible effects of the ultrasound beam on tissue, the intensity encoun-
tered at the tissue site must be calculated. Because of attenuation of the beam within the body,
the intensity at the tissue site (“in situ”) may be 10 to 100 times less than if it was measured at
the same location in water. The amount of attenuation from experience by an ultrasound beam
as it travels through the body tissue is determined by three factors:

1. Type of tissue along the beam path

2. Frequency of the ultrasound energy
3. Distance covered by the beam

In order to achieve a conservative approximation of attenuation due to these three factors, the
FDA requires the application of the following formula:
Id = Iw exp (-0.23 a f z)
• Id is the estimated “In Situ” intensity at the tissue site
• Iw is the intensity measured in water at the distance “z”, measured in cm
• a is the attenuation coefficient expressed in dB/cm/MHz
• f is equal to the acoustic frequency in MHz of the ultrasound beam

xxviii SIGMA 110/SIGMA 330 15.10.01

Definition of terms

The Acoustic Intensity generated by an ultrasound probe is usually described as follows:

Ispta
The Spatial Peak Time Average Intensity is an ultrasound intensity averaged over time at the
point in the acoustic field where the pulse average intensity is at maximum.

Isppa
The Spatial Peak Pulse Average Intensity is an ultrasound intensity averaged over the pulse
transmission time at a point in the acoustic field where the pulse average intensity is at maxi-
mum.

Imax
The Maximum Intensity is an average intensity during the half-cycle with the greatest amplitude
during the pulse.

Mechanical Index MI
The Mechanical Index is defined as the peak rarefactional pressure in MPa (derated by a tissue
attenuation coefficient of 0.3 dB/cm/MHz) divided by the square root of the probe central fre-
quency in MHz.

Thermal Index TI
The Thermal Index is the ratio between the acoustic power and the power required to raise tissue
temperature by 1°C, estimated on Thermal Models.

Peak rarefactional pressure

The Peak rarefactional pressure (pr in MPa) is temporal peak rarefactional pressure amplitude at
a specified point.

Pulse Intensity Integral

The Pulse Intensity Integral (PII) is time integral of instantaneous velocity for any specific point
and for any specific pulse, integrated over the time in which the envelope of acoustic pressure or
the envelope of hydrophone signal for the specific pulse is non-zero. It is equal to the energy flu-
ence per pulse.

15.10.01 GENERAL INFORMATION xxix

IV. Compliance with Standards
SIGMA 110 and SIGMA 330 systems manufactured by KONTRON MEDICAL, entirely comply
with the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, and bear the
CE Mark.
They are in compliance with
• CE MDD mark
• German K.V. regulation
• IEC 601-1 Class 1 Type B (Electrical Safety)
• IEC 1157 (Acoustic power reporting)
• FDA 510 (k)
Consequently, all OEM equipment (video recorders, external TV monitors and other peripherals)
should be:
• connected to the three isolated outputs provided by SIGMA 330 Expert or Excellence cart or
to wall outlets using the proper isolator (see Chapter 6.3, “Accessories”, on page 6-5 for
ordering).
• marked with CE identification mark and be in compliance with IEC 950 or IEC 601-1 Stand-
ards.

xxx SIGMA 110/SIGMA 330 15.10.01

 1. INSTRUMENT DESCRIPTION

15.10.01 INSTRUMENT DESCRIPTION 1-1

1-2 SIGMA 110/SIGMA 330 15.10.01
1 .1 Introduction

SIGMA 110 and SIGMA 330 are Ultrasound Diagnostic Systems intended for scanning in multi-
application. They both support 2D, TM and spectral Doppler ultrasound modes. SIGMA 330
additionally supports Colour Flow Mapping (CFM).
SIGMA 110/330 can be used in following applications:
• Abdominal
• Breast
• Cardiology
• Emergency
• Endocrinology
• Gastro-enterology
• Gynaecology
• Musculoskeletal
• Neonatology
• Obstetrics
• Paediatrics
• Small parts
• Urology
• Vascular

SIGMA 330 features some unique characteristics in its category:

• Dual Optimization Technique (D.O.T.)
• Auto-adaptive Frequency Adjustment (A.F.A.TM)
• Advanced Tissue Echo Cancellation (A.T.E.C.TM)
• EasyPrintTM (Option)
• USB-LinkTM (Option)
• PW/CW spectral Doppler (Option)
• CFM (Option)
• Multi-frequency and Multi-technology Transducers (M.M.T.)
• Up to 5 transducers simultaneously connected
• Super High Frequency Transducer (S.H.F.T.)
• Iris colour system for optimal rendering of echo structures
• 256 levels grey scale
• Up to 282 images cine-loop
• KIPRISM, digital storage
• Ergonomic design for optimal user comfort
• Remote Control

15.10.01 INSTRUMENT DESCRIPTION 1-3

The SIGMA 110 Family features some unique characteristics in its category:
• Dual Optimization Technique (D.O.T)
• Auto-Adaptive Frequency Adjustment (A.F.A.TM)
• Advanced Tissue Echo Cancellation (A.T.E.C.TM)
• EasyPrintTM (Option)
• USB-LinkTM (Option)
• Multi-frequency and Multi-technology Transducers (M.M.T.)
• Up to 5 transducers simultaneously connected
• Super High Frequency Transducer (S.H.F.T.)
• 256 levels grey scale
• Ergonomic design for optimal user comfort (E.D.O.)
• PW/CW spectral Doppler (Option)
• Up to 282 images cine-loop (Option)
• KIPRISM, digital storage
• Remote Control (Option)

1-4 SIGMA 110/SIGMA 330 15.10.01

1 .2 SIGMA 1 1 0/330 Equipments
The table below shows the composition of the SIGMA 110/SIGMA 330 family.

Name Relationship
SIGMA 110 Light SIGMA 110 accepting Annular Sector probes only
SIGMA 110 accepting Annular Sector probes and Linear/ Convex
SIGMA 110 Master
probes
SIGMA 330 Master SIGMA 330 including colour monitor and Iris features
SIGMA 330 Master with integrated cart and dual port for Linear/ Con-
SIGMA 330 Expert
vex probes
SIGMA 330 Excellence SIGMA 330 Expert with Colour Doppler (CFM) and extended capabili-
without Frame Grabber ties (Picture Archiving and Communication System, etc.)
SIGMA 330 Excellence SIGMA 330 Expert with Colour Doppler (CFM) and extended capabili-
with Frame Grabber ties (3D, Picture Archiving and Communication System, etc.)

Table 1 -1 : SIGMA 110/330 family

The SIGMA 110/330 systems are available in different language versions.
The following table lists the ordering reference numbers of the SIGMA 110/SIGMA 330 models.

References
Models English French German Italian Spanish Cyrillic
SIGMA 110
480 770 483 788 483 966 484 121 484 318 484 482
Light
SIGMA 110
482 110 485 012 485 195 485 365 485 543 485 713
Master
SIGMA 330
482 080 485 209 485 373 485 551 485 721 485 918
Master
SIGMA 330
482 420 483 818 483 982 484 156 484 334 484 504
Expert
SIGMA 330
Excellence
483680EN 483680FR 483680GE 483680IT 483680SP 483680CY
without frame
grabber board
SIGMA 330
Excellence
483400EN 483400FR 483400GE 483400IT 483400SP 483400CY
with frame
grabber board

Table 1 -2: Reference numbers of SIGMA 110/SIGMA 330

15.10.01 INSTRUMENT DESCRIPTION 1-5

The following table summarizes the configurations of the SIGMA 110/SIGMA 330 models:
SIGMA 110 SIGMA 330
PRODUCT Excellence
Light Master Master Expert
w/o FG with FG

Start-up label (SIGMA ...)a 110 Light 110 330 330 330 330
Integrated Cart 9 9 9
Bolero Cart Option Option Option
Probes holder set 9 9 9
Handle Option Option Option
Colour monitor, Iris featuresb 9 9 9 9
Linear/Convex probes 9 9 9 9 9
Spectral Dopplerc Option Option
CFM+ Power+ Spectral Doppler Option Option 9 9
Cine Option Option 9 9 9 9
ECG Option Option Option Option Option
Remote Control Option Option 9 9 9 9
CONFIGURATION

Footswitch Option Option Option 9 9 9

Option Option
Switchbox 9 9 9
(external) (external)
Repetition Monitor Option Option Option Option
PCMCIA Memory Card Flash Flash SRAM 4MB SRAM 4MB SRAM 4MB SRAM 4MB
VHS option Option Option Option Option Option Option
Time Renting Option Option Option Option Option Option
EasyPrint™ Black & Whited Option Option
EasyPrint™ Color Option Option 9 9
USB-Link™ Option Option Option Option 9 9
Integrated compact PC and
9 9
Flat 15" LCD Monitor for PC
3D-Fetal View™ option Option
3D-Vascular View™ option Option
PACSe SonoWinlite® option Option Option Option Option Option Option
PACSe SonoWinbasic® option Option Option Option Option Option Option
KIPRISMf 9 9 9 9 9 9
Cardiology featuresg 9 9 9 9 9 9

Table 1 -3: System configuration and options

a. Label displayed in the start-up or system information screens.
b. Iris features include colour gamma curves (Rainbow) and colorised screen layout (measurement, technical
data, etc.).
c. Spectral-Doppler option includes PW, CW, Cine review, Angio package and VMean / VMax traces.
d. Requires Cine option.
e. Picture Archiving and Communication Systems. Please contact your local dealer for more information.
f. The complete features of Digital Archiving are obtained with Cine option. Without Cine only the Store feature
is available.
g. Cardiology includes cardiology formats and setups, biometry and measurements, ECG display that requires
ECG module.

1-6 SIGMA 110/SIGMA 330 15.10.01

1 .3 Physical Description
The basic SIGMA 1 1 0/330 is a transportable Ultrasound unit which includes the following sub-
assemblies:
• Electronic cabinet containing all electronic modules
• Keyboard panel
• Black and White or colour video monitor
• Stereo audio system for Doppler
• Video Cassette Recorder output
• Black & White and colour Printer output

The SIGMA 1 1 0 Light, SIGMA 1 1 0 Master and the SIGMA 330 Master consist of the basic
SIGMA 110/330 and a transducer holder kit for two transducers and for a bottle of ultrasonic gel.
A front view of these versions and the front panel opened showing the keyboard and screen are
shown in figure 1-1, “SIGMA 110 Light, Master and SIGMA 330 Master”, on page 1-8.

The SIGMA 330 Expert consists of the basic SIGMA 110/330 system combined with an inte-
grated cart which provides:
• Room for optional Video Cassette Recorder
• Room for optional Printers
• Room for accessories
• Elevating column for user-adaptative height
The pedal on the base of the instrument is used to control the desired position: press the pedal to
lift up; while keeping the pedal depressed, push down the column top part to get it down.

In addition to the SIGMA 330 Expert features, the SIGMA 330 Excellence includes a flat screen
associated with an integrated personal computer for 3D imaging and patient data management.

15.10.01 INSTRUMENT DESCRIPTION 1-7

 Figure 1 -1 : SIGMA 110 Light, Master and SIGMA 330 Master

1-8 SIGMA 110/SIGMA 330 15.10.01

 Figure 1 -2: SIGMA 330 Expert

15.10.01 INSTRUMENT DESCRIPTION 1-9

 Figure 1 -3: SIGMA 330 Excellence

1-10 SIGMA 110/SIGMA 330 15.10.01

1 .3.1 Electronic Cabinet
The electronic cabinet includes the required circuitry to perform complete functions.
‰ Power Supply

‰ Processor which controls the main system functions and the user interface.

‰ Transmitter/receiver modules for both linear/convex and sector transducers.

‰ Scan Converter

‰ Digital processing and filtering

‰ Spectral-Doppler

‰ Colour Flow Mapping

1 .3.2 Control Panel

The Control Panel is connected to the main electronic board through a serial line. Its ergonomics
allows the user to communicate easily with the system.
The keyboard includes a backlight that allows the system to be used in semi-darkness.
The Control Panel includes:
• 23 function keys
• 10 menu function keys. Their current functions are displayed on the corresponding
MENU on the screen.
• 1 incremental potentiometer (softpot). Its current function is displayed in the correspond-
ing MENU on the screen.
• 1 potentiometer for 2D or TM gain adjustment.
• 1 potentiometer for spectral gain adjustment in CFM, PW and CW.
• 1 potentiometer for depth selection.
• 5 sliders (rectilinear potentiometers) for gain equalization.
• 1 alphanumerical keyboard with standard upper case characters and useful graphic
characters.
• 1 trackball with corresponding function keys.
• 1 Power ON/OFF button
• 1 Remote control

15.10.01 INSTRUMENT DESCRIPTION 1-11

1.3.2.1 Keyboard

The controls located on the keyboard are listed below and shown in figure 1-4, “Keyboard”, on
page 1-13.

1. Remote control unit location

2. Power ON/OFF key
3. Potentiometer joined to function menus
4. Alphanumerical keys
5. MENU key
6. Menu function keys joined to menus displayed on screen
7. MENU PREVIOUS/NEXT keys
8. Time Gain Compensation (TGC)
9. Function keys
10. 2D/TM gain
11. CFM/PW/CW gain
12. Depth
13. FREEZE key
14. Validation (SET) keys joined to the trackball, 3 independent keys
15. Trackball

1-12 SIGMA 110/SIGMA 330 15.10.01

 3 4 5 6 7 8

10
1

11

12

15 14 13

Figure 1 -4: Keyboard

15.10.01 INSTRUMENT DESCRIPTION 1-13

1.3.2.2 Remote Control Unit

It allows the remote control for main scanning parameters, freeze and image printing.
The main advantages of the remote control are:
• System control in any inadequate examination condition.
• Usage in operating room, because it can be easily disinfected.
• Operation in difficult environment.
• Group demonstration or lesson.

7 8 9 10 11 12 13

6
5
4
3
2
1
Figure 1 -5: Remote Control Unit

The different keys available on the remote controller are the following:

1. MAGNIFY: Magnify the ultrasound image by a factor 2

2. SCROLL SP (+/-): Scrolling in Trace Modes
3. DEPTH (+/-): Depth change
4. ON/OFF: Power ON/OFF
5. BASELINE (+/-): Baseline shift in PW/CW and CFM mode
6. FREQ (+/-): Freq +/- in 2D, frequencies in PW/CW and CFM
7. VELOCITY (+/-): Velocity in PW/CW and CFM modes
8. CW: CW mode switch
9. PRINT: Equivalent to PRINT1 on the keyboard
10. 2D, CFM, PW, TM: Mode switch
11. FREEZE key
12. GAIN (+/-): 2D gain in 2D, SP gain in Doppler, CFM gain in CFM
13. Trackball keys

The 3 keys SCROLL SP, BASELINE and VELOCITY, access directly to the corresponding Dop-
pler parameters described in Chapter 3.7.3.2, “PW Live Menu”, on page 3-36. For changing the
selected parameter, use (-) and (+) keys.

1-14 SIGMA 110/SIGMA 330 15.10.01

For example, to modify the scroll speed:

1. Press SCROLL SP key to select the parameter.

2. Press (-) key to decrease the scroll speed or press (+) key to increase it.

The DEPTH key accesses directly to the corresponding 2D parameter described in Chapter
3.7.1.2, “2D Live Menu”, on page 3-28. For changing the parameter, proceed as described
above.
MAGN. and FREQ are toggle keys described in Chapter 3.7.1.2, “2D Live Menu”, on page 3-28.
In PW/CW mode FREQ. corresponds directly to the frequency item displayed in the Doppler
Menu on screen described in Chapter 3.7.3.2, “PW Live Menu”, on page 3-36 and Chapter
3.7.4.2, “CW Live Menu”, on page 3-41
The (-GAIN+) key modifies the overall gain according to the active mode. Press the left side of
the key to decrease the gain or press the right side to increase it.
The trackball function of the control panel is replaced by 4 arrows and a button located in the
centre. Use the arrows for moving in the four directions and press the button for validating the
operation.
The keys PRINT, TM, 2D, SELECT, CFM, PW, CW and FREEZE, access directly to the corre-
sponding functions described in Chapter 1.4, ÚSystem ControlsÛ , on page 1-28.
The Remote Control Unit is powered by two 1.5 V batteries (see Chapter 6.3, “Accessories”, on
page 6-5 for ordering).

1 .3.3 TV Monitor

1.3.3.1 General

SIGMA 110 units are equipped with a high quality 10" Black & White monitor to display images
and information.
SIGMA 330 units are equipped with a high quality 10" colour monitor to display images and infor-
mation.
The monitor is integrated into the instrument housing.

1.3.3.2 Controls

If the image is not satisfactory, check whether all controls are in the correct position for an opti-
mum adjustment. The location of the controls is described in figure 1-6, “SIGMA 110 Light,
SIGMA 110 Master and SIGMA 330 Master front view”, on page 1-17.

15.10.01 INSTRUMENT DESCRIPTION 1-15

 This page is intentionally left blank

1-16 SIGMA 110/SIGMA 330 15.10.01

1 .3.4 Front Panel

1.3.4.1 SIGMA 110 Light, Master and SIGMA 330 Master Front View

The following items are shown in figure 1-6, “SIGMA 110 Light, SIGMA 110 Master and SIGMA
330 Master front view”, on page 1-17:

1. Audio volume adjustment

2. Brightness adjustment for video screen
3. Contrast adjustment for video screen
4. Loudspeakers
5. Remote control receiver
6. Location dedicated to Remote Control Unit
(Remote Control Unit is optional with SIGMA 110)
7. Video screen
8. Receptacle for bottle of gel
9. Probe holder
10. Keyboard

1 7

2 8

3
9
4

5 4

6 10

Figure 1 -6: SIGMA 110 Light, SIGMA 110 Master and SIGMA 330 Master front view

15.10.01 INSTRUMENT DESCRIPTION 1-17

1.3.4.2 SIGMA 330 Expert Front View

The following items are shown in figure 1-8, “SIGMA 330 Expert front view”, on page 1-19:

1. Audio volume adjustment

2. Brightness adjustment for video screen
3. Contrast adjustment for video screen
4. Loudspeakers
5. Remote control receiver
6. Remote Control Unit
7. Keyboard
8. Cabinet for optional Video Printer
9. Cabinet for optional Video Cassette Recorder
10. Cabinet for accessories
11. Control pedal for carrying up/down the column
12. Video screen (colour monitor)

Figure 1 -7: SIGMA 330 Expert front view (closed)

1-18 SIGMA 110/SIGMA 330 15.10.01

 1 12

4 4

10

11

Figure 1 -8: SIGMA 330 Expert front view

15.10.01 INSTRUMENT DESCRIPTION 1-19

1.3.4.3 SIGMA 330 Excellence Front View

The following items are shown in figure 1-9, “SIGMA 330 Excellence front view”, on page 1-21:

1. Additional high resolution flat screen

2. Compact personal computer integrated in the lower cabinet

1-20 SIGMA 110/SIGMA 330 15.10.01

 1

Figure 1 -9: SIGMA 330 Excellence front view

15.10.01 INSTRUMENT DESCRIPTION 1-21

1 .3.5 Rear Panel

1.3.5.1 SIGMA 330 Expert Rear Panel

1. Fuses (Electronic cabinet - top part)

2. Switch ON/OFF (Electronic cabinet - top part)
3. Mains plug (Electronic cabinet - top part)
4. Equalization potential terminal (Chassis Ground)
5. Probe holder
6. Guide for probe cable
7. Handle
8. Connectors for Linear/Curved Probes
9. Fuses (SIGMA 110/330 cart - bottom part)
10. Switch ON/OFF (SIGMA 110/330 cart - bottom part)
11. Mains plug (SIGMA 110/330 cart - bottom part)
12. Equalization potential terminal (Chassis Ground)
13. Equalization potential terminal (Chassis Ground)
14. Connector panel
15. Connector for Doppler Pencil Probes
16. Receptacle for bottle of gel
17. Connectors for Annular Sector Probes
18. Air filter grid
19. Identification labels:
• at the top: (CE mark, model, reference, serial number, revision number)
• at the bottom: (model, reference, serial number)
Output power: 3 outlets for peripherals (see Chapter 2.7.2, “Output Power Source”, on page
2-11)

1-22 SIGMA 110/SIGMA 330 15.10.01

 1

19
2

18
3
17

16
4

5
15
6

7 6

14

9 13

10

11 12

Figure 1 -1 0: SIGMA 330 Expert rear panel

15.10.01 INSTRUMENT DESCRIPTION 1-23

1.3.5.2 SIGMA 330 Excellence Rear Panel

1. Fuses (Electronic cabinet - top part)

2. Switch ON/OFF (Electronic cabinet - top part)
3. Mains plug (Electronic cabinet - top part)
4. Equalization potential terminal (Chassis Ground)
5. Probe holder
6. Guide for probe cable
7. Handle
8. Connectors for Linear/Curved Probes
9. Fuses (SIGMA 110/330 cart - bottom part)
10. Switch ON/OFF (SIGMA 110/330 cart - bottom part)
11. Mains plug (SIGMA 110/330 cart - bottom part)
12. Equalization potential terminal (Chassis Ground)
13. Equalization potential terminal (Chassis Ground)
14. Connector panel
15. Connector for Doppler Pencil Probes
16. Receptacle for bottle of gel
17. Connectors for Annular Sector Probes
18. Air filter grid
19. Identification labels:
• at the top: (CE mark, model, reference, serial number, revision number)
• at the bottom: (model, reference, serial number)
Output power: 3 outlets for peripherals (see Chapter 2.7.2, “Output Power Source”, on page
2-11)

1-24 SIGMA 110/SIGMA 330 15.10.01

 1
19
2

18
3
17

16
4

6 15
7
6

14
8

13
9

10
12
11

Figure 1 -1 1 : SIGMA 330 Excellence rear panel

15.10.01 INSTRUMENT DESCRIPTION 1-25

1.3.5.3 SIGMA 110 Light, Master and SIGMA 330 Master Rear Panel

1. Fuses (see Chapter 2.7.1, “Input Power Source”, on page 2-10)

2. Switch ON/OFF
3. Mains plug
4. Probe holder
5. Bottle of gel receptacle
6. Equalization potential terminal (Chassis Ground)
7. Identification label (CE mark, model, reference, serial number, revision number)
8. Connector for Linear/Curved Probes (Master)
9. Air filter grid
10. Connectors for Annular Sector Probes
11. Connector for Doppler Pencil Probes
12. Connector panel

1 7

3 8

5 10

11

6 12

Figure 1 -1 2: SIGMA 110 Light, Master and SIGMA 330 Master rear panel

1-26 SIGMA 110/SIGMA 330 15.10.01

1.3.5.4 Connector Panel

1 2 3 4 5 6 7 8 9 10 11 12

Figure 1 -1 3: Connector panel

Before connecting any equipment to these connectors read carefully, "Chapter III.1, “Intended
Clinical Use”, on page -xv" and Chapter III.2, “Safety Information”, on page -xviii.

1. Service connector
2. Video printer 2 remote control
3. Video printer 1 remote control
4. Remote Power Switch
5. Line Printer (parallel Port)
6. Serial Interface COM1, ECG
7. Keyboard
8. USB Port
9. Monitor
10. Video printer
11. SVHS VCR & Audio Input/Output
12. Foot switch

15.10.01 INSTRUMENT DESCRIPTION 1-27

1 .4 System Controls
Definition of the control keys shown in figure 1-4, “Keyboard”, on page 1-13:

1 .4.1 Alphanumeric Keys

Alphanumeric keys access to all upper case characters. Useful graphic characters are accessed
with using of the SHIFT key.

1.4.1.1 ESC Key

The ESCape key is a generic key that:

• leaves any menu and return to the previous one.
• aborts any string (entry and restore the previous one, if possible).
• is available as often as possible to give user possibility to correct its manipulation errors.
• aborts current measurement.
• returns to previous study sheet or exits report when first sheet is displayed.

1.4.1.2 POWER ON/OFF Key

The POWER key switches ON or OFF system power. For Power OFF a confirmation menu is dis-
played, with a key for action aborting. This is to prevent a user manipulation error.

1.4.1.3 MENU Key

The MENU key is a toggle key displaying and hiding the menu of current functions. This menu is
depending on the current state and mode.
The (<) PREVIOUS and (>) NEXT keys located close right of the function keys, are used to
access the next/previous menu page if other menu pages are available.

2 F1 F2 F3 F4 F5
0

MENU
F6 F7 F8 F9 F10

1.4.1.4 F1 to F10 Keys

Select functions displayed in menu on the screen. If it is an action-function, the action is immedi-
ately performed.
If it is an adjustment function (this can be recognized by the symbol on screen), the user has
to make an adjustment using the potentiometer on the left of the function keys.

1.4.1.5 ID Key

The ID key calls the starting page and menu for entering new patient information, laboratory and
operator identification.

1-28 SIGMA 110/SIGMA 330 15.10.01

1.4.1.6 PROBE

The PROBE key displays the probe MENU showing the names of the connected probes. User
can select the operating probe. On probe selection, the corresponding probe setups are loaded
and live image starts.

1.4.1.7 SETUP Key

The SETUP key displays a menu giving an user action choice on setups and preferences.
‰ Load SETUP: replaces working parameters of current probe by parameters saved in the
SETUP.
‰ Save SETUP: Save working parameters of current probe as preset values.

‰ Preferences: Date & Time, Doppler Scale (m/s or kHz), Printer Selection, Patient ID, Tech-
nical Data, Cine Mode and Refresh setup.

1 .4.2 Live Investigation Keys

1.4.2.1 FREEZE Key

The FREEZE key is a toggle key starting and stopping image scanning. This key is always ena-
bled. Action on freeze key displays menu of current mode on the screen. When the report is dis-
played, action on freeze key exits report and displays live ultrasound image.
This key includes a relief mark for easy tactile recognition.

1.4.2.2 PRINT1 and PRINT2 Keys

The PRINT1 and PRINT2 key control video printers.

The PRINT1 key is always enabled and attached to a B&W video printer.
The PRINT2 key can be configured for colour video printer or for digital archiving (KIPRISM).
The configuration can be done with the SETUP menu.
Just before start printing, the live image is frozen and any menu removed from the screen. Just
after printing, previous system state is automatically restored.

1.4.2.3 2D Key

The 2D key sets the system in 2D mode (not all probes are 2D compatible).

1.4.2.4 TM Key

The TM key sets the system in TM mode (not all probes are 2D compatible).

1.4.2.5 CFM Key

The CFM key sets the system in CFM mode (only if linear probes are attached to the system,
mechanical probes can not be used for CFM).
This key exists only on SIGMA 330 systems + option CFM.

15.10.01 INSTRUMENT DESCRIPTION 1-29

1.4.2.6 PW Key

The PW key sets the system in PW mode.

1.4.2.7 CW Key

The CW key sets the system in CW mode. (not all probes are CW compatible, see table i, “Probe
applications,” on page -xvi)

1.4.2.8 MAGNIFY Key

The MAGNIFY key is used to display an ultrasound image area magnified by a factor 2 in live or
freeze mode in 2D/CFM mode.

1.4.2.9 SELECT Key

The SELECT key acts when 2 or more images are displayed on the screen. It freezes current
image pad, if needed, and sets in live mode the next one.

1.4.2.10 GAIN Pots

The GAIN pots change the gain of the current image (2D, TM, CFM, PW or CW). It has no action
in freeze mode. Out of the gain range limits, the system emits a sound beep to warn the user.
The gain pot which is currently active, is backlighted.

1.4.2.11 TGC Pots

The TGC (Time Gain Control) is achieved by 5 sliders (rectilinear potentiometers). Five zones
are vertically defined on the image. Each slider corresponds to one of the 5 zones and adjusts
the gain in this one. TGC acts only in 2D and TM.

1.4.2.12 DEPTH Pot

The DEPTH pot changes depth of current image (2D or TM). It has no action in freeze mode. Out
of the depth range limits, a beep sounds to warn the user.

1 .4.3 Keys for Frozen Image Study

1.4.3.1 BODYMRK

The BODYMRK key displays the current body marker set according to the current medical appli-
cation

1.4.3.2 ANNOTATE

The ANNOTATE key displays or hides the annotation menu on the screen and automatically
freezes image. Annotation menu enables annotation writing, displays cursors or body markers on
the screen.

1-30 SIGMA 110/SIGMA 330 15.10.01

1.4.3.3 MEASURE

The MEASURE key displays or hides the measurement menu on the screen and automatically
freezes ultrasound image.

1.4.3.4 REPORT

The REPORT key enters or exits the report screen and automatically freezes image. When exit-
ing report, the system returns to frozen ultrasound image display.

1 .4.4 Trackball
The trackball and the 3 trackball buttons are linked together. These buttons have different func-
tions:

Upper left key Upper right key

Lower key

The actions associated to those keys are:

‰ Upper left key is used to select the next available action in the action list,
‰ Upper right key is used to select the previous available action in the action list,

‰ Lower key is used to select the position cursor.

Action lists are managed in a circular manner: if the upper right (upper left) key is pressed and if
the current selected action is the last one (the first one) then the next selected action will be the
first (last) action of the actions list.
This convention is used for each mode except for:
• Measurement,
• Biometry,
• Annotation,
• Pop-up menus,
• KIPRISM (see, Chapter 3.11.2.3, “Principles of Selection and Validation”, on page 3-53)
• PC Mode (see, Chapter 3.20.4, “PC remote control features description”, on page
3-111)
Some functions are linked to the trackball:
• Magnify and Zoom: moves zoomed or magnified area.
• Annotation/add text: set position of cursor.
• Annotation/Arrow mark: set arrow position on image.
• Measures.

15.10.01 INSTRUMENT DESCRIPTION 1-31

 • Patient menu.
• Report.
The trackball is not attached to several functions simultaneously (except in PW live mode).
The trackball is attached to the last selected function. When the current function ends, the track-
ball attachment returns to the previous one.

1.4.4.1 Positioning of the Cursor

In any imaging mode, live and freeze, the user can move a "Position Cursor" on the screen to
point to a region of interest.
Press the lower key to display the cursor and move it using the trackball.
Press the lower key again to erase the cursor and return to previous function.

1-32 SIGMA 110/SIGMA 330 15.10.01

1 .5 Screen Layout
1 .5.1 Ultrasound Screen Layout

General information, date & time

Colour/Grey scale

Technical data
Zoom indicator
AFA indicator

Meas. result

print
icon

ECG message

Tilt Body
icon Menu keys M1-M10 Mag. Mark.
icon

Figure 1 -1 4: Screen Layout

1.5.1.1 General information and Date & Time

In this area following information are displayed:

• the laboratory references
• the operator name
• the patient name
• the current date and time

Laboratory Operator Date Time

Patient Name

general information fields

According to the user preferences (set in the setup menu), the content of the general information
fields can be displayed or not. These fields are set in the Patient ID form.
The content of the laboratory and the operator fields are saved in the Non Volatile RAM and dis-
played at each start-up.

15.10.01 INSTRUMENT DESCRIPTION 1-33

1.5.1.2 Colour/Grey Scale

According to the current mode (2D or CFM mode), the colour and/or the grey scales are dis-
played on the left part of the screen. The display rules of both scales are the following:
• scales are never displayed in full TM mode
• scales are displayed in all the other modes when no overlapping between the scales and
the ultrasound image is possible.
• scales have an height of 128 pixels in single 2D or CFM and 80 pixels in the other
modes.
‰ The grey scale
From the 128 (CFM mode) or 256 (2D mode) ultrasound possible grey levels only 16 are
displayed in the grey scale.
Remark: in CFM mode the displayed grey scale has the half of the width of the grey scale
displayed in 2D.
‰ The colour scale
The colour scale is only displayed in CFM modes (single or multi-pad modes) and is always
associated to the grey scale (when colour scale is displayed, grey scale also displayed). In
this mode, two different types of colour scales can be displayed.
• the 128 colour levels are displayed in Power and Velocity mode
• if imaging of turbulence is activated in Velocity mode 32 colour levels and 96 turbulence
levels distributed into 128 colours are displayed.
The colour baseline shift has no influence on the number of displayed colours, which is always
equal to 128 levels.
Colour & Grey scale design

+31

Baseline
Wall filter Velocity
marker Range

Colour Threshold -31

cm/s

Grey scale Colour scale

Unit

1.5.1.3 Technical Data

See Chapter 1.5.3, “Technical Data Area”, on page 1-38.

1.5.1.4 Measurement Results

See Chapter 3.14, “Measurements”, on page 3-67.

1-34 SIGMA 110/SIGMA 330 15.10.01

1.5.1.5 Icons

Four types of icons can be displayed on the SIGMA screen:

the freeze symbol icon displayed when the system is frozen

the magnify icon displayed when the 2D or CFM image is magnified

displayed with tiltable probes (6.5 EV). This symbol indicates the
the tilt icon
current scanned part

temporary displayed when the user press on one of the two print
the print icon
keys

1.5.1.6 Zoom Indicator

On the left side of the menu the range scale is drawn. This scale locates
the zoomed part of the 2D image. By moving the trackball up or down
the current displayed area will be moved and the zoom range indicator Zoom range
indicator
will be modified.

1.5.1.7 ECG

Menu and ECG pads are always displayed one above the other. The menu is always displayed.

Menu

The colour of the ECG trace is CYAN with a colour monitor and WHITE with a B/W monitor.

1.5.1.8 Auto Frequency Adjustment (AFA)

The Auto Frequency Adjustment marker (A.F.A.) shows the current ultrasound
5
working frequency bandwidth of the transducer in 2D. This working frequency MHz
bandwidth depends on actual selected scan depth and on the Freq+/Freq- setting.
For each transducer, depth and frequency setting, A.F.A selects the optimal fre-
quency bandwidth of the transducer.
A.F.A. is available in single 2D mode and Freeze mode. 1
AFA display is selectable in the Preferences Menu. MHz

15.10.01 INSTRUMENT DESCRIPTION 1-35

1 .5.2 Menu

1.5.2.1 Function Key Menu

Function Keys on the keyboard are named F1 to F10 and Menu Items on the screen M1 to M10
to get understanding of the following description easier.
MP, as Menu Potentiometer, is for the incremental potentiometer.
MK is for the MENU key.
(<) is for the PREVIOUS key
(>) is for the NEXT key.
Function Keys F1 to F10 are respectively attached to the corresponding Menu Items
M1 to M10 (e.g. pressing F1 acts on M1)

2 F1 F2 F3 F4 F5
0

MENU
F6 F7 F8 F9 F10

Figure 1 -1 5: Function Keys

A specific menu exists for each mode. The current menu is automatically displayed when enter-
ing mode. For example, pressing 2D key enters 2D mode and displays 2D menu. MK key is used
to display or hide menu. (<) (>) keys are used to access previous/next menu page when more
than one is available.
There are two types of displayed menu: single or double.
‰ Single Menu is displayed on 1 line and consists of 5 Menu Items M1 to M5.

M1 M2 M3 M4 M5

F1 F2 F3 F4 F5

F1’ F2’ F3’ F4’ F5’

Figure 1 -1 6: Single Menu Display

For Single Menu the Fi and Fi' keys have the same action. Press indifferently F1 or F1' to select
M1 menu item.
‰ Double Menu is displayed on 2 lines and consists of 10 Menu Items M1 to M10.

1-36 SIGMA 110/SIGMA 330 15.10.01

 M1 M2 M3 M4 M5

M6 M7 M8 M9 M10

F1 F2 F3 F4 F5

F6 F7 F8 F9 F10

Figure 1 -1 7: Double Menu Display

1.5.2.2 PopUp Menu Used for Labels and Body markers

When activating label or body marker menu, a list is displayed in place of the technical and
measurement data. More details on labels and body marker management are available in
Appendix L, “Body Markers”, on page 7-111

15.10.01 INSTRUMENT DESCRIPTION 1-37

1 .5.3 Technical Data Area
This chapter describes technical data of SIGMA 110/330 in the different modes.
In multi-pad mode, the common parameters (i.e. Gamma, Smooth, ...) are the ones of the active
pad.

1.5.3.1 Technical Data Formats

Most of parameter values are preceded by a character label so that the user can easily identify
their meaning. In the following sections the different value formats are described: xx means that 2
characters are displayed.

‰ Non labelled data

• Probe: probe name (including its working frequency).
• Application: the probe medical application.
• Sub-Application in CFM mode1: name of the selected CFM Sub-Application (Liver &
Vein, Kidney, Abdom. Artery, Periph. Artery, Periph. Vein and Fetal Heart) or the scan-
ning method (Scan Fast or Scan Normal in Cardio).
• Depth: xx cm
• Quality: Freq+ or Freq-
• Doppler frequency (SPFreq): x MHz
• Doppler mode: CW or PW
• CFM frequency (CFMFreq): x.xMHz
• Frame rate in 2D and CFM mode: xx fps

‰ Labelled data
• 2D Gain: BGainxx
• Gamma: Gamma x
• Rainbow: Rainb x
• Enhance: Enh x
• Reject: Rej x
• Smooth: Smoothx
• Zoom Factor: Mag x.x
• Gate size: Gatexxmm
• Spectral Wall filter: WxxxxHz
• Vector: Vec+xx°
• Doppler Gain: DGainxx
• Spectral Energy: En -xxdB
• CFM Gain: CGainxx
• Resolution: Res Low, Res Med or Res Hi
• Persistence: Pers x
1. The parameter Sub-application is different from the biometry Medical Application. The later is only relevant
to annotation, body marker, measurement and biometry modules.

1-38 SIGMA 110/SIGMA 330 15.10.01

 • Colour Map: ColMapx
• CFM Energy: En -xxdB
• Thermal Index1: TISx.x or TIBx.x (or MI x.x when the probe is a
pencil probe or TIC x.x when the probe is a TCD2
probe).
• Mechanical Index: MI xx.x

1.5.3.2 2D and [2D]/TM Technical Data

The techdata for the 2D and [2D]/TM modes are organized as described below:
Probe Probe Appl. name Application
Depth xx cm BGainxx 2D Gain
Quality Freq+ Smooth x Smooth
Enhance Enh x Rej x Reject
Gamma Gamma x Rainb x Rainbow
Zoom Factor Mag x.x xx fps Frame Rate
TI/MI TI xx.x

The “Zoom Factor” field is optional: it contains the zoom or the magnify factor and will only be dis-
played if Mag or Zoom is on.

1.5.3.3 2D/[TM] Technical Data

These ones contains the 2D data (except the “Zoom Factor”) and the TM data:
Probe Probe Appl. name Application
Depth xx cm BGainxx 2D Gain
Quality Freq+ Smooth x Smooth
Enhance Enh x Rej x Reject
Gamma Gamma x Rainb x Rainbow
xx fps Frame Rate
TI/MI TI xx.x

1.5.3.4 TM Technical Data

In this mode, only the information relevant to the TM single pad are displayed:
Probe Probe Appl. name Application
Depth xx cm BGainxx 2D Gain
Quality Freq+
Enhance Enh x Rej x Reject
Gamma Gamma x Rainb x Rainbow

TI/MI TI xx.x

1.5.3.5 Double 2D and Quad 2D Modes

In these modes the technical data window contains the information concerning the active image.
See Chapter 1.5.3.2, “2D and [2D]/TM Technical Data”, on page 1-39.

1. Only one of the thermal or the mechanical index will be displayed at a time.

15.10.01 INSTRUMENT DESCRIPTION 1-39

1.5.3.6 2D/SP, 2Di/SP Technical Data

These technical data contains the 2D data and also the PW ones:
Probe Probe Appl. name Application
Depth xx cm BGainxx 2D Gain
Quality Freq+ Smooth x Smooth
Enhance Enh x Rej x Reject
Gamma Gamma x Rainb x Rainbow
Zoom Factora Mag x.x TI xx.x Frame Rate

PW/CW PW DGainxx Doppler Gain

SPFreq x.x MHz Vec+xx° Vector
SPWall Filter WxxxxHz En -xxdB SP Energy
GateSizeb
Gatexxmm TI xx.x

TIx/MIc
a. Zoom mode only
b. PW mode only
c. only displayed when image is active and live

1.5.3.7 CFM and [CFM]/TM Technical Data

The most relevant CFM information are displayed here:

Probe Probe Appl. name Application
Sub-Application Subappl. name
Depth xx cm CGainxx CFM Gain
Resolution Res Low Pers x Persistence
CFMFreq x.x MHz xx fps Frame Rate
Color Map ColMapx En -xxdB CFM Energy
2D Gain BGain xx
Zoom Factora Mag x.x
TIxb
TI xx.x

a. only if Mag or Zoom is on

b. in live mode only

When “Color Off” is pressed, the 2D technical data are displayed (See Chapter 1.5.3.2, “2D and
[2D]/TM Technical Data”, on page 1-39).

1.5.3.8 CFM/[TM] Technical Data

See Chapter 1.5.3.3, “2D/[TM] Technical Data”, on page 1-39

1-40 SIGMA 110/SIGMA 330 15.10.01

1.5.3.9 [CFM]/SP Technical Data

The CFM information is inserted in the 2D/SP techdata:

Probe Probe Appl. name Application
Sub-Application Subappl. name
Depth xx cm CGainxx CFM Gain
Resolution Res Low Pers x Persistence
CFMFreq x.x Mhz xx fps Frame Rate
Color Map ColMapx En -xxdB CFM Energy
2D Gain BGainxx

PW/CW PW
SPFreq. x.x MHz DGainxx Doppler Gain
SPWall Filter WxxxxHz Vec+xx° Vector
GateSizea Gatexxmm En -xxdB SP Energy
TI/MIb
TI xx.x

a. PW mode only
b. in live mode only
When the “Color Off” key is pressed, the 2D/SP technical data are displayed (Chapter 1.5.3.6,
“2D/SP, 2Di/SP Technical Data”, on page 1-40).

1.5.3.10 CFM/[SP] Technical Data

Chapter 1.5.3.6, “2D/SP, 2Di/SP Technical Data”, on page 1-40

15.10.01 INSTRUMENT DESCRIPTION 1-41

1 .6 Display Modes
1 .6.1 2D Modes

2D (single 2D) 2D+2D (dual) Quad 2D

zoomed zoomed
area image area

magnified
zone

Mechanical zoom Linear zoom

Magnified 2D
only the zoomed area is displayed

Figure 1 -1 8: 2D Display Modes

1 .6.2 TM Modes

2D or CFM+TM TM

Figure 1 -1 9: TM Display Modes

1-42 SIGMA 110/SIGMA 330 15.10.01

1 .6.3 CW and PW Modes

2D+CW 2Di+CW

2D or CFM+PW 2Di or CFMi+PW

Figure 1 -20: CW and PW Display Modes

Remark: the CFM+CW modes are not available because the CFM is only possible with linear
probes and the CW mode only with mechanical or pencil probes.

1 .6.4 CFM Formats

CFM Linear zoom

Magnified CFM
only the zoomed areas are displayed
magnified
zone

Figure 1 -21 : CFM Display

These formats are only available for linear transducers. It is composed of 2 images displayed one
over the other: the 2D image (on the back) and the Colour Flow Mapping image (on the front)

15.10.01 INSTRUMENT DESCRIPTION 1-43

1 .7 SIGMA 1 1 0 Technical Specifications
1 .7.1 General
The SIGMA 110 is a 2D, TM and spectral Doppler transportable ultrasound scanner for general
purpose applications:
• Abdominal
• Breast
• Cardiology
• Emergency
• Endocrinology
• Gastro-enterology
• Gynaecology
• Obstetrics
• Paediatrics
• Small parts
• Musculoskeletal
• Neonatology
• Urology
• Vascular
SCANNING TECHNIQUES
• Electronic linear scanning
• Electronic convex scanning
• Annular array sector scanning
• Doppler Pencil probes
DISPLAY MODES
• Real time 2D (B-Mode) display modes:
• Single 2D format
• Double 2D format
• Quad 2D format
• 2D panoramic zoom (for mechanical probes only)
• 2D scroll zoom (for LINEAR/CONVEX probes only)
• 2D magnification
• TM (M-Mode) display modes:
• Quasi Duplex 2D + TM: 2D (50% screen) + TM (50% screen)
• Full screen TM
• CW display modes:
• Quasi Duplex 2D + CW: 2D (50% screen) + CW (50% screen)
• 2Di (icon) + CW
• PW display modes:

1-44 SIGMA 110/SIGMA 330 15.10.01

 • Quasi Duplex 2D + PW: 2D (50% screen) + PW (50% screen)
• 2Di (icon) + PW
MONITOR
• Black & White monitor, 10" diagonal
• 640 x 480 pixels resolution
• Direct management of brightness and contrast
• includes loudspeakers and control knob for volume
KEYBOARD
• Six languages: English, French, German, Italian, Spanish and Russian (Cyrillic)
• Backlightening of all keys and knobs
• Ten software controlled function keys for menu selection
• Full alphanumeric capabilities
• B/W video printer remote control
• Trackball for focus point setting, TM, CW/PW line steering, annotations positioning,
measurements, cine-mode review and arrow pointing
• Layout removable for cleaning operation
• Trackball removable for cleaning operation
INFRARED REMOTE CONTROL (option)
• Ensure system control in any inadequate examination condition
• Allow the remote control for scanning parameters, freeze and image printing
• Dedicated place on keyboard
SCREEN LAYOUT
• Patient identification field including patient name clinic name, operator name, time and
date
• Technical data field showing all pertinent imaging parameters
• Measurement field displaying the last ten measurement results
• Menu field activated by the corresponding function key
• Freeze mode indicator
• Cine-loop memory index (option)
• Annotation arrows and user defined annotations with trackball controlled positioning
• Image orientation indicator
• Over 51 body markers with scan plane indication
• Dot lines for TM/CW/PW beam orientation
• Real time ECG trace display
• Biopsy channel indication with automatic calibration of depth, probe type, left/right
guides and angle up/down orientation
SETTINGS
• Default settings related to the medical application and transducer for image quality opti-
mization
• User settings memorized in the system as well as on a flash card

15.10.01 INSTRUMENT DESCRIPTION 1-45

1 .7.2 2D (B-Mode)
SCANNING SECTOR
• Angle: 40, 45, 60, 75, 90, 110 and 140° for Annular Sector (Probe dependent)
• Angle: 30, 45, 60, 75, 90 and 110° for Convex Array (Probe dependent)
• Depth: 2 cm to 24 cm, up to 10 depths (Probe dependent)
• Nominal frequency range: 2 to 14 MHz (Probe dependent)
FRAME RATE
• Up to 200 fps (probe and medical application dependent)
• Depending on depth, angle and medical application
SIGNAL PROCESSING
• Large bandwidth: 1.5 - 18 MHz
• Overall Gain: 32 steps
• Time Gain Compensation: 5 sliders
• Dynamic focusing on reception
• Up to four focus zones on transmission
• Automatic adjustment of reception bandwidth for each depth
• Contour enhancement: 7 positions application dedicated
• Dynamic range control (reject): 4 positions to increase the contrast and reduce weak
echoes
• Frame filter: 4 non linear smoothing filters + OFF position
• Automatic Frequency Adjustment (A.F.A.) for standard and less echogenic patient
(Freq+/Freq-)
• Grey scale optimization thanks to 8 Gamma curves (probe dependent)
IMAGE PRESENTATION
• Single, Double and Quad image representation
• Freeze mode
• Left/right
• Up/Down
• Video inversion
RESOLUTION
• 512 x 512 pixels on screen for 2D image display
• 256 grey levels
IMAGE MEMORY (option)
• Cine Mode: up to 282 images (probe and medical application dependent)

1 .7.3 TM (M-Mode)
SIGNAL PROCESSING
• Same as 2D mode
IMAGING PARAMETERS
• Scrolling speed:

1-46 SIGMA 110/SIGMA 330 15.10.01

 • 2, 3, 5, 8 sec./screen (full screen)
• 1, 1.5, 2.5, 4 sec./screen (2D + TM)
M LINE STEERING
• Trackball controlled over complete 2D sector
DISPLAY
• 2D (50% screen) + TM (50% screen)
• Full screen TM
IMAGE MEMORY
• Cine Mode:
• up to 16 trace screens in full TM
• up to 5 trace screens in 2D + TM

1 .7.4 Spectral Doppler Mode

AVAILABLE MODES
• Steerable PW
• Steerable CW
SIGNAL PROCESSING
• Multi-frequency Doppler mode: 2, 3, 4 and 8 MHz (probe dependent)
• Velocity range:
• PW: +/-1 kHz to +/- 10 kHz
• CW: +/-1 kHz to +/- 20 kHz
• +/- 10 cm/sec. to +/- 3.5 m/s (PW), +/- 7.2 m/sec. (CW), full scale, depending on
probe and operating frequency
• High pass wall filter: 10 cut-off frequencies adjustable between 50 to 1000 Hz
• Grey scale optimization with 8 post-processing curves (probe dependent)
• Spectrum gain control: 11 selections between 0 and 30 dB
• 120 dB dynamic range for best sensitivity
• 256 point FFT, computing time of 0.2 ms
• Doppler transmit power control: 8 selections between 0 dB and -21 dB
• Doppler angle correction: from -80 to 80 °
• Scrolling speed:
• 2, 3, 5, 8 sec./screen (full screen)
• 1, 1.5, 2.5, 4 sec./screen (2D + SP)
• Adjustable audio volume
PW GATE
• PW gate adjustable for sample volumes between 1 and 15 mm (8 selections)
• PW gate adjustable with the trackball between 0 and maxi depth of the image format
DISPLAY
• 2D (50% screen) + Doppler (50% screen)
• 2D icon + Doppler

15.10.01 INSTRUMENT DESCRIPTION 1-47

 • Base line shift: 9 positions for optimal signal display, avoiding spectrum aliasing
• VMEAN real time trace display
• VMAX+ and VMAX- real time trace display
• Quasi duplex automatic refresh: 4 levels, according to scrolling speed
IMAGE MEMORY
• Cine Mode:
• up to 16 trace screens in full Doppler
• up to 5 trace screens in 2D + Doppler
ACOUSTIC POWER OUTPUT
• Fulfils acoustic output display standards
• Complies with FDA acoustic output limits
• Automatic power output adjustment versus medical application for optimal Doppler per-
formance (ALARA)
• User selectable Doppler transmit power attenuation:
8 positions between 0 dB and -21 dB

1 .7.5 Digital Archiving: KIPRISM

• Digital archiving on Memory Card: the number of ultrasound images which can be
stored, is depending on memory card capacity
• up to 32 images on 4 megabytes memory card
• up to 64 images on 8 megabytes memory card
• etc.
• Transfer on Personal Computer via memory card (PCMCIA standard, DOS format)

1 .7.6 ECG Module (option)

FORMATS
• for all single or dual pad formats
INPUT
• Isolated input, type CF, Defibrillator proof (IEC 601-1)
• through serial port, 240 x 8 bit / second, QRS trigger available
• ECG Gain: 1000 (1V / 1 mV)
• Heart rate: up to 180 bpm
• Recovery time after defibrillator shock: > 5 sec
B MODE TRIGGER
• in single and dual B mode available, trigger moment may be set by user.
• For dual pad modes two independent triggers can be set.
DISPLAY and CINE REVIEW
• Display trace (on video screen)
• Indication of time relationship between 2D mode image and ECG trace by marker on
ECG trace. Cine review on trace modes is also available.

1-48 SIGMA 110/SIGMA 330 15.10.01

1 .7.7 EasyPrintTM
• Direct output to inkjet printer
• Compatible with HP PCL level III

1 .7.8 USB-LinkTM
• Digital transfer of images and report text files to Personal Computer through USB cable
• Compatibility: refer to Chapter 3.18.2, “Compatibility”, on page 3-99.

1 .7.9 Peripherals (Optional)

The following peripherals can be connected to the system:
• VCR (VHS and S-VHS)
• B/W video printer
• Parallel DeskJet printer (PC compatible) for images (EasyPrintTM) and report printout
• B/W monitor

1 .7.1 0 Inputs/Outputs
• S-VHS/VHS (including audio) input/output for VCR connection, PAL/NTSC compatible,
video playback automatically fed to the monitor
• Black & White video composite output for B/W video printer connection
• Double footswitch (Freeze/ Print/ Select image)
• Memory card connector (PCMCIA) dedicated to software upgrade, user setup storage
and digital archiving (KIPRISM)
• RGB video output for external monitor and color video printer
• Parallel port for images and report printout
• Serial port for peripheral devices
• USB port for data transfer to PC

1 .7.1 1 Measurement
CALIPERS
• Trackball controls the multiple callipers
• Complete measurement capabilities on frozen images
• 2D: distance, surface and circumference of area, surface and circumference of ellipse,
angle; distance and area ratio
• TM: distance, time, slope, heart rate, distance and time ratio, LV studies
• PW/CW: speed gradient, frequency, time, acceleration, integral, PI & RI, RI, heart rate,
speed, gradient and time ratio
• Specific measurements for OB/GYN
• Up to 10 result lines on screen

15.10.01 INSTRUMENT DESCRIPTION 1-49

ANNOTATIONS
• Annotation collection
• Text, arrows, body markers
PATIENT REPORT
• Automatic selection of relevant measurement from patient report
• Comprehensive report for each medical application: Radio, Vasc., Ob/Gyn, Pediatry,
Cardio.
• Peripheral vascular: stenosis percentage, continuity equation, resistance index, steno-
sis index, pulsatility index, spectral broadening index, flow volume, frequency
• Abdominal: volume 1 to 4 (user-defined), cardiac output, diameter, continuity equation
• Pediatric: hip angles
• Ob/Gyn: extensive measurements capabilities including BPD, FML, CRL, BOD, ABD,
THD, AC, GES, HC, OFD, APD, TAD, Foetal Weight, Estimated Birth Date
• Cardio: left ventricular volumetry using Simpson, area length single and bi-plane formu-
las, systolic and diastolic volume using Teichholz rule, shortening fraction, myocardial
mass and mass index, left ventricular circumference, ejection fraction, cardiac output
and index, stroke volume and index, mean velocity, pressure and mean pressure gradi-
ent, pressure half time and valve area, time to peak velocity in systole, right and left ven-
tricular ejection time and pre-ejection period, right ventricular systolic pressure,
continuity equation, QP/QS
• All applications: body surface area (BSA)
MEASUREMENT ACCURACY
Mode: Parameters: Typical accuracy:
• Distance • < +/- 3%
• 1 mm, when 3% of the measured
2D value is less than 1 mm
• Angle < +/- 2.5 °
• Distance • < +/- 1%
• 0.5 mm, when 1% of the meas-
ured value is less than 0.5 mm
TM
• Time < +/- 1%
• Slope < +/- 2%
• Speed < +/- 5% of max. displayed velocity
• Frequency < +/- 5% of max. displayed frequency
SP • Gradient < +/- 10%
• Time < +/- 1%
• Acceleration < 10%
HR • Heart rate computed by ECG +/- 1 bpm

Table 1 -4: Measurement Accuracy

1-50 SIGMA 110/SIGMA 330 15.10.01

1 .7.1 2 Acoustic Power
SIGMA 110 complies with the FDA Standards.
Acoustic power depends on Medical Application.
• ISPPA < 190 W/cm2 (Medical Application independent)
• Im < 310 W/cm2 (Medical Application independent)
• ISPTA in situ, in mW/cm2

MEDICAL
CARDIO VASC. RADIO, OB/GYN
APPLICATION
ISPTA In situ, in mW/cm2 < 430 < 720 < 94

Table 1 -5: Acoustic Intensity

• Accuracy of MI display: +/- 30 %
• Accuracy of TI display: +/- 50 %

1 .7.1 3 Environment
TEMPERATURE
• Operating temperature: 10 °C to 40 °C (50 °F to 104 °F)
• Storage temperature: -20 °C to 40 °C (-4 °F to 104 °F)
HUMIDITY
• Operating humidity: 30% to 80%, non condensing
• Storage humidity: 30% to 95%, non condensing
ATMOSPHERIC PRESSURE
• Operating pressure: 700 mbar to 1060 mbar
• Storage pressure: 500 mbar to 1060 mbar
ELECTRICAL SPECIFICATIONS
• Input voltage: 100 - 127 V~ and 200 - 240 V~
• Mains frequency: 50 - 60 Hz
• Consumption: 340 VA
ELECTROMAGNETIC FIELD
• Maximum field strength without degradation of performance: 1 V/m

1 .7.1 4 Regulation and Safety

• CE MDD mark
• German K.V. regulation
• IEC 601-1 Class 1 Type B (Electrical Safety)
• IEC 1157 (Acoustic power reporting)
• FDA 510 (k)

15.10.01 INSTRUMENT DESCRIPTION 1-51

1 .7.1 5 Dimensions
• Height: 380 mm
• Width: 470 mm
• Depth: 526 mm
• Weight: 29 kg

1-52 SIGMA 110/SIGMA 330 15.10.01

1 .8 SIGMA 330 Technical Specifications
1 .8.1 General
The SIGMA 330 is a 2D, TM, Spectral Doppler and Color Flow Mapping ultrasound scanner for
general purpose applications:
• Abdominal
• Breast
• Cardiology
• Emergency
• Endocrinology
• Gastro-enterology
• Gynaecology
• Musculoskeletal
• Neonatology
• Obstetrics
• Paediatrics
• Small parts
• Urology
• Vascular
SCANNING TECHNIQUES
• Electronic linear scanning
• Electronic convex scanning
• Annular array sector scanning
• Doppler Pencil Probes
DISPLAY MODES
• Real time 2D (B-Mode) display modes:
• Single 2D format
• Double 2D format
• Quad 2D format
• 2D panoramic zoom (for AS probes only)
• 2D scroll zoom (for LINEAR/CONVEX probes only)
• 2D magnification
• 3D1
• 3D-Fetal ViewTM
• 3D-Vascular ViewTM
• TM (M-Mode) display modes:
• Quasi Duplex 2D + TM: 2D (50% screen) + TM (50% screen)
• Full screen TM

1. SIGMA 330 Excellence only

15.10.01 INSTRUMENT DESCRIPTION 1-53

 • CW display modes:
• Quasi Duplex 2D + CW: 2D (50% screen) + CW (50% screen)
• 2Di (icon) + CW
• PW display modes:
• Quasi Duplex 2D + PW: 2D (50% screen) + PW (50% screen)
• 2Di (icon) + PW
• CFM display modes:
• Single CFM
• Quasi Duplex CFM + PW: CFM (50% screen) + PW (50% screen)
• CFMi (icon) + PW
• Colorised 2D, TM, PW & CW mode display
MONITOR
• Colour monitor
• 10" diagonal
• 640 x 480 pixels resolution
• PAL/NTSC compatible
• Direct management of brightness and contrast
• includes loudspeakers and control knob for volume
• LCD flat panel colour monitor1
• 15" diagonal
• 800 x 600 pixels resolution
KEYBOARD
• Six languages: English, French, German, Italian, Spanish and Russian (Cyrillic)
• Backlightening of all keys and knobs
• Ten software controlled function keys for menu selection
• Full alphanumeric capabilities
• B/W and colour video printer remote control
• Trackball for TM, CW/PW line steering, PW gate positioning, CFM colour window resiz-
ing and positioning, focus point setting, annotation positioning, measurements and cine-
mode review
• Layout removable for cleaning operation
• Trackball removable for cleaning operation
INFRARED REMOTE CONTROL
• Ensure system control in any inadequate examination condition
• Allow the remote control for scanning parameters, freeze and image printing
• Dedicated place on keyboard
SCREEN LAYOUT
• Patient identification field including patient name, clinic name, operator name, time and
date
1. SIGMA 330 Excellence only

1-54 SIGMA 110/SIGMA 330 15.10.01

 • Technical data field showing all pertinent imaging parameters
• Measurement field displaying the last ten measurement results
• Menu field activated by the corresponding function key
• Freeze mode indicator
• Cine-loop memory index
• Annotation arrows and user defined annotations with trackball controlled positioning
• Image orientation indicator
• Over 51 body markers with scan plane indication
• Indication of CFM ROI position and size
• Dot lines for TM/CW/PW beam orientation
• Real time ECG trace display
• Biopsy channel indication with automatic calibration of depth, probe type, left/right
guides and angle up/down orientation
• CFM window
SETTINGS
• Default settings related to the medical application and transducer for image quality opti-
mization
• User settings memorized in the system as well as on a flash card

1 .8.2 2D (B-Mode)
SCANNING SECTOR
• Angle: 40, 45, 60, 75, 90, 110 and 140° for Annular Sector (Probe dependent)
• Angle: 30, 45, 60, 75, 90 and 110° for Convex Array (Probe dependent)
• Depth: 2 cm to 24 cm, up to 10 depths (Probe dependent)
• Nominal frequency range: 2 to 14 MHz (Probe dependent)
FRAME RATE
• Up to 218 fps
• Depending on depth, angle and medical application
SIGNAL PROCESSING
• Large bandwidth: 1.5 - 18 MHz
• Overall Gain: 32 steps
• Time Gain Compensation: 5 sliders
• Dynamic focusing on reception
• Up to four focus zones on transmission
• Automatic adjustment of reception bandwidth for each depth
• Contour enhancement: 7 positions application dedicated
• Dynamic range control (reject): 4 positions to increase the contrast and reduce weak
echoes
• Frame filter: 4 non linear smoothing filters + OFF position

15.10.01 INSTRUMENT DESCRIPTION 1-55

 • Automatic Frequency Adjustment (A.F.A.) for standard and less echogenic patient
(Freq+/Freq-)
• Grey scale optimization thanks to 8 Gamma curves (probe dependent)
• Iris colour system
IMAGE PRESENTATION
• Single, Double and Quad image representation
• Freeze mode
• Left/right
• Up/Down
• Video inversion
RESOLUTION
• 512 x 512 pixels on screen for 2D image display
• 256 grey levels
IMAGE MEMORY
• Cine Mode: up to 282 images (probe and medical application dependent)

1 .8.3 TM (M-Mode)
SIGNAL PROCESSING
• Same as 2D mode
IMAGING PARAMETERS
• Scrolling speed:
• 2, 3, 5, 8 sec./screen (full screen)
• 1, 1.5, 2.5, 4 sec./screen (2D + TM)
M LINE STEERING
• Trackball controlled over complete 2D sector
DISPLAY
• 2D (50% screen) + TM (50% screen)
• Full screen TM
IMAGE MEMORY
• Cine Mode:
• up to 16 trace screens in full TM
• up to 5 trace screens in 2D + TM

1 .8.4 Spectral Doppler Mode

AVAILABLE MODES
• Steerable PW and CW
• Multi-frequency Doppler modes
• Spectral colorization
• Automatic 2D image update when adjusting Doppler cursor position
SIGNAL PROCESSING

1-56 SIGMA 110/SIGMA 330 15.10.01

 • Doppler frequencies: 2, 3, 4 and 8 MHz (probe dependent)
• Velocity range:
• PW: +/-1 kHz to +/- 10 kHz
• CW: +/-1 kHz to +/- 20 kHz Doppler shift (PRF/2)
• +/- 10 cm/sec. to +/- 3.5 m/s (PW), +/- 7.2 m/sec. (CW), full scale, depending on
probe and operating frequency
• High pass wall filter: 10 cut-off frequencies adjustable between 50 to 1000 Hz
• Grey scale optimization with 8 post-processing curves (probe dependent)
• Spectrum gain control: 11 selections between 0 and 30 dB
• 120 dB dynamic range for best sensitivity
• 256 point FFT, computing time of 0.2 ms
• Doppler transmit power control: 8 selections between 0 dB and -21 dB
• Doppler angle correction: from -80 to 80 °
• Scrolling speed:
• 2, 3, 5, 8 sec./screen (full screen)
• 1, 1.5, 2.5, 4 sec./screen (2D + SP)
• Adjustable audio volume
• Iris colour system
PW GATE
• PW gate adjustable for sample volumes between 1 and 15 mm (8 selections)
• PW gate adjustable with the trackball between 0 and maxi depth of the image format
DISPLAY
• 2D (50% screen) + Doppler (50% screen)
• 2D icon + Doppler
• Base line shift: 9 positions for optimal signal display, avoiding spectrum aliasing
• VMEAN real time trace display
• VMAX+ and VMAX- real time trace display
• Quasi duplex automatic refresh: 4 levels, according to scrolling speed
IMAGE MEMORY
• Cine Mode:
• up to 16 trace screens in full Doppler
• up to 5 trace screens in 2D + Doppler
ACOUSTIC POWER OUTPUT
• Fulfils acoustic output display standard
• Complies with FDA acoustic output limits
• Automatic power output adjustment versus medical application for optimal Doppler per-
formance (ALARA)
• User selectable Doppler transmit power attenuation: 8 positions between 0 and -21 dB

15.10.01 INSTRUMENT DESCRIPTION 1-57

1 .8.5 Colour Doppler Modes
MODES
• Steerable Color Flow Mapping (CFM) on electronic array probes
• Velocity, Variance and Power mode
• Automatic 2D/CFM image update when adjusting Doppler cursor position
SIGNAL PROCESSING
• Multi frequency CFM mode: 2.5, 3, 5 and 6 MHz (Probe dependent and user selectable)
• High pass wall filter: 6 cut-off frequencies adjustable between 44 to 4400 Hz (depend-
ant on velocity range)
• Colour gain control: 32 positions between 0 and 20 dB
• 4 positions colour persistence
• Velocity Ranges: from ± 125 Hz to ±7.5 kHz Doppler shift (PRF/2) or ±1.6 cm/s to
±2.8 m/s full scale, depending on probe, frequency and medical application
CFM WINDOW
• From 10% to full length of 2D sector, trackball controlled resize
• From 10% to full width of 2D sector, trackball controlled resize
• Trackball control of window position within 2D sector
DISPLAY
• Up to 128 colour shades, 8 levels of turbulence
• 8 user selectable colour maps for optimum rendering of either low velocities, high veloc-
ities and turbulence
• 9 positions of baseline shift
• Turbulence on/off
• Colour invert
• Chroma maps for optimum rendering of 2D echo structures
• Up to 64 frames cine memory
ACOUSTIC OUTPUT
• Fulfils acoustic output display standard
• Complies with FDA acoustic output limits
• Automatic power output adjustment versus medical application for optimal Doppler per-
formance (ALARA)
• User selectable Doppler transmit power attenuation: 8 positions between 0 dB and - 21
dB

1 .8.6 3D Imaging1
2 highly intuitive user interface packages:
‰ 3D - Fetal View™ (2D reconstruction)

‰ 3D - Vascular View ™ (2D and CFM reconstruction)

• Quick and easy 3D acquisition

1. SIGMA 330 Excellence only

1-58 SIGMA 110/SIGMA 330 15.10.01

 • Instantaneous multiplanar 3D reconstruction (MPR)
• 3D application specific rendering algorithms
• 3D segmentation tools (advanced filter operations)
• Image export to standard PC file format (.bmp and .avi)
• Digital archiving

1 .8.7 Digital Archiving: KIPRISM

• Digital archiving on Memory Card:
• up to 32 images on 4 megabytes memory card
• up to 64 images on 8 megabytes memory card
• Transfer on Personal Computer via memory card (PCMCIA standard, DOS format)
• Images in PCX format, report in TXT format
• Up to 15000 color images per archiving media (640 MB)
• DICOM 3.0 compatible (with PACS option)

1 .8.8 ECG Module (option)

FORMATS
• for all single or dual screen formats
INPUT
• Isolated input, type CF, Defibrillator proof (IEC 601-1)
• through serial port, 240 x 8 bit / second, QRS trigger available
• ECG Gain: 1000 (1V / 1 mV)
• Heart rate: up to 180 bpm
• Recovery time after defibrillaror shock: > 5 sec
B MODE TRIGGER
• in single and dual B mode available, trigger moment may be set by user.
• For dual pad modes two independent triggers can be set.
DISPLAY and CINE REVIEW
• Display trace (on video screen)
• Indication of time relationship between 2D mode image and ECG trace by marker on
ECG trace. Cine review on trace modes is also available.

1 .8.9 EasyPrintTM
• Direct output to inkjet printer
• Compatible with HP PCL level III

1 .8.1 0 USB-LinkTM
• Digital transfer of images and report text files to Personal Computer through USB cable.
• Compatibility: refer to Chapter 3.18.2, “Compatibility”, on page 3-99.

15.10.01 INSTRUMENT DESCRIPTION 1-59

1 .8.1 1 Peripherals (Optional)
All the following peripherals can be connected to the system:
• VCR (VHS and S-VHS)
• B/W video printer
• Color video printer
• Parallel DeskJet printer (PC compatible) for images (EasyPrintTM) and report printout
• B/W monitor
• Color monitor

1 .8.1 2 Inputs/Outputs
• S-VHS/VHS (including audio) input/output for VCR connection, PAL/NTSC compatible,
video playback automatically fed to the monitor
• Black & White video composite output for B/W video printer connection
• Double footswitch (Freeze / Print/Select image)
• Memory card connector (PCMCIA) dedicated to software upgrade, user setup storage
and digital archiving (KIPRISM)
• RGB video output for external monitor and color video printer
• Parallel port for images and report printout
• Serial port for peripheral devices
• USB port for data transfer to PC

1 .8.1 3 Measurement
CALIPERS
• Trackball controls the multiple callipers
• Complete measurement capabilities on frozen images
• 2D: distance, surface and circumference of area, surface and circumference of ellipse,
angle, volume; distance and area ratio
• TM: distance, time, slope, heart rate; distance and time ratio; LV studies
• PW/CW: speed gradient, frequency, time, acceleration, integral, PI & RI, RI, heart rate;
speed, gradient and time ratio
• CFM: velocity, velocity profile and frequency
• Specific measurements for OB/GYN
• Up to 10 result lines on screen
ANNOTATIONS
• Annotation lists: user-defined
• Text, arrows, body markers
PATIENT REPORT
• Automatic selection of relevant measurement from patient report
• Comprehensive report for each medical application: Radio, Vasc., Ob/Gyn, Pediatry,
Cardio.

1-60 SIGMA 110/SIGMA 330 15.10.01

 • Peripheral vascular: stenosis percentage, continuity equation, resistance index, steno-
sis index, pulsatility index, spectral broadening index, flow volume, frequency
• Abdominal: volume 1 to 4 (user-defined), cardiac output, diameter, continuity equation
• Pediatric: hip angles
• Ob/Gyn: extensive measurements capabilities including BPD, FML, CRL, BOD, ABD,
THD, AC, GES, HC, OFD, APD, TAD, Foetal Weight, Estimated Birth Date
• Cardio: left ventricular volumetry using Simpson, area length single and bi-plane formu-
las, systolic and diastolic volume using Teichholz rule, shortening fraction, myocardial
mass and mass index, left ventricular circumference, ejection fraction, cardiac output
and index, stroke volume and index, mean velocity, pressure and mean pressure gradi-
ent, pressure half time and valve area, time to peak velocity in systole, right and left ven-
tricular ejection time and pre-ejection period, right ventricular systolic pressure,
continuity equation, QP/QS
• All applications: body surface area (BSA)
MEASUREMENT ACCURACY
Mode: Parameters: Typical accuracy:
• Distance • < +/- 3%
• 1 mm, when 3% of the measured
2D value is less than 1 mm
• Angle < +/- 2.5 °
• Distance • < +/- 1%
• 0.5 mm, when 1% of the meas-
ured value is less than 0.5 mm
TM
• Time < +/- 1%
• Slope < +/- 2%
• Speed < +/- 5% of max. displayed velocity
• Frequency < +/- 5% of max. displayed frequency
SP • Gradient < +/- 10%
• Time < +/- 1%
• Acceleration < 10%
• Velocity < +/- 10% of the velocity range
CFM
• Frequency < +/- 10% of the frequency range
HR • Heart rate computed by ECG +/- 1 bpm

Table 1 -6: Measurement Accuracy

1 .8.1 4 Acoustic Power

The acoustic power depends on Medical Application.
• ISPPA < 190 W/cm2 (Medical Application independent)
• Im < 310 W/cm2 (Medical Application independent)

15.10.01 INSTRUMENT DESCRIPTION 1-61

 • ISPTA In situ, in mW/cm2, is shown in the table below

MEDICAL
CARDIO VASC. RADIO, OB/GYN
APPLICATION
ISPTA In situ, in mW/cm2 < 430 < 720 < 94

Table 1 -7: Acoustic Intensity

• Accuracy of MI display: +/- 30 %
• Accuracy of TI display: +/- 50 %

1 .8.1 5 Environment
TEMPERATURE
• Operating temperature: 10 °C to 40 °C (50 °F to 104 °F)
• Storage temperature: -20 °C to 40 °C (-4 °F to 104 °F)
HUMIDITY
• Operating humidity: 30% to 80%, non condensing
• Storage humidity: 30% to 95%, non condensing
ATMOSPHERIC PRESSURE
• Operating pressure: 700 mbar to 1060 mbar
• Storage pressure: 500 mbar to 1060 mbar
ELECTRICAL SPECIFICATIONS
• Input voltage: 100 - 127 and 200 - 240 V~
• Mains frequency: 50 - 60 Hz
• Consumption: 340VA (main unit only), 680 VA (with integrated cart and peripherals)
ELECTROMAGNETIC FIELD
• Maximum field strength without degradation of performance: 1 V/m

1 .8.1 6 Regulation and Safety

• CE MDD mark
• German K.V. regulation
• IEC 601-1 Class 1 Type B (Electrical Safety)
• IEC 1157 (Acoustic power reporting)
• FDA 510 (k)

1 .8.1 7 Dimensions
SIGMA 330 Master
• Height: 380 mm
• Width: 470 mm
• Depth: 526mm
• Weight: 29 kg

1-62 SIGMA 110/SIGMA 330 15.10.01

SIGMA 330 Expert
• Height: 1230 mm (min.) - 1305mm (max.)
• Width: 580 mm
• Depth: 684 mm
• Weight: 90 kg
SIGMA 330 Excellence
• Height: 1230 mm (min.) - 1305 mm (max.)
• Width: 580 mm
• Depth: 684 mm
• Weight: 103 kg

15.10.01 INSTRUMENT DESCRIPTION 1-63

 This page is intentionally left blank

1-64 SIGMA 110/SIGMA 330 15.10.01

 2. INSTALLATION

10.12.01 INSTALLATION 2-1

2-2 SIGMA 110/SIGMA 330 10.12.01
2.1 Installation Requirements
Be sure that the site is sufficiently ventilated and do not install the instrument near any important
heat source.
In order to prevent an overheating, ensure that the ventilation openings are not covered and keep
the rear panel away from a vertical wall.
Bring the package relief as close as possible to the required operating location.
It is recommended to provide two people for removing SIGMA 110/330 from its package.

2.2 Unpacking
2.2.1 Warning
Installation must be performed by authorized KONTRON MEDICAL SAS personnel. Any attempt
by unauthorized personnel to install the instrument may invalidate the KONTRON MEDICAL SAS
warranty.
If the instrument is received in damaged conditions, request an immediate inspection by the car-
rier and local KONTRON MEDICAL representative.

2.2.2 Unpacking the Instrument

SIGMA 110 and SIGMA 330 instruments are packed in non-returnable packings.

2.2.2.1 SIGMA 110 Light/Master and SIGMA 330 Master

These models are packed in a cardboard box. Remove it carefully.

2.2.2.2 SIGMA 330 Expert and SIGMA 330 Excellence

The upper part (Monitor) is packed in a cardboard box. Remove it carefully.

For SIGMA 330 Excellence, the flat screen and micro-computer are packed in a separate card-
board box. Remove them carefully.
The instrument body (Cart) is packed into a wood crate:
‰ Remove the top and side boards.

‰ Remove the foam protecting the instrument.

‰ Remove the instrument from the pallet.

2.3 Checking the Instruments Identification

The identification label with designation, reference number and serial number is affixed to the
rear panel (see figure 1-10, “SIGMA 330 Expert rear panel”, on page 1-23, figure 1-11, “SIGMA
330 Excellence rear panel”, on page 1-25 and figure 1-12, “SIGMA 110 Light, Master and SIGMA
330 Master rear panel”, on page 1-26).

10.12.01 INSTALLATION 2-3

2.4 Checking the Delivery
Check the contents of the consignment with the delivery note that is supplied with each system. If
parts are missing or damaged, inform your local KONTRON MEDICAL representative.
Following standard parts are supplied with the instrument.
For ordering optional accessories, refer to Chapter 6.3, “Accessories”, on page 6-5.

Qty. Ref. Designation

1 100 250 250 ml bottle of ultrasound gel
1 411 353 Power cable (EURO/D CEE 22)
1 (or) 487 848 Power cable "North American Hospital Grade" (for US)
1 485 055 Memory card 4 MB (PCMCIA) for SIGMA 110 Light and Master
1 477 729 Memory card 4 MB - SRAM (PCMCIA) for SIGMA 330 Master
1 484 164 Memory card label
1 DOC31001EN Operator Manual - English (according to system language)
1 462 489 Medical Ultrasound Safety Guide (for US only)
1 (or) DOC31001FR Operator Manual - French (according to system language)
1 (or) DOC31001GE Operator Manual - German (according to system language)
1 (or) DOC31001IT Operator Manual - Italian (according to system language)
1 (or) DOC31001SP Operator Manual - Spanish (according to system language)
1 (or) DOC31001CY Operator Manual - Russian (Cyrillic, according to system language)
1 483 184 Remote control Unit - English (according to system language)a
1 (or) 483 176 Remote control Unit - French (according to system language)a
1 (or) 483 168 Remote control Unit - German (according to system language)a
1 (or) 483 141 Remote control Unit - Italian (according to system language)a
1 (or) 483 133 Remote control Unit - Spanish (according to system language)a
1 (or) 483 125 Remote control Unit - Cyrillic (according to system language)a
2 524 204 Fuse, 5 x 20 mm, T 2 A
2 717 150 Fuse, 5 x 20 mm, T 4 A (according to line voltage)
1 487 090 Notice for NTSC fuses
1 481 033 Remote control cable for Video printer
1 862 169 Coaxial cable (75, BNC/BNC, L = 2 m)
1 487 163 USB cable (A/BM/M 15 Pts, L = 1.8 m)b
2 471 059 Air filter
1 426 016 Quality Control form

Table 2-1 : Supplying list for SIGMA 110 Light/Master and SIGMA 330 Master
a. only for SIGMA 330 Master
b. when USB-Link™ option is installed

2-4 SIGMA 110/SIGMA 330 10.12.01

 Qty. Ref. Designation
1 100 250 250 ml bottle of ultrasound gel
1 411 353 Power cable (EURO/D CEE 22)
1 (or) 487 848 Power cable "North American Hospital Grade" (for US)
1 477 729 Memory card 4 MB - SRAM (PCMCIA)
1 484 164 Memory card label
1 DOC31001EN Operator Manual - English (according to system language)
1 462 489 Medical Ultrasound Safety Guide (for US only)
1 (or) DOC31001FR Operator Manual - French (according to system language)
1 (or) DOC31001GE Operator Manual - German (according to system language)
1 (or) DOC31001IT Operator Manual - Italian (according to system language)
1 (or) DOC31001SP Operator Manual - Spanish (according to system language)
1 (or) DOC31001CY Operator Manual - Russian (Cyrillic, according to system language)
1 483 184 Remote control Unit - English (according to system language)
1 (or) 483 176 Remote control Unit - French (according to system language)
1 (or) 483 168 Remote control Unit - German (according to system language)
1 (or) 483 141 Remote control Unit - Italian (according to system language)
1 (or) 483 133 Remote control Unit - Spanish (according to system language)
1 (or) 483 125 Remote control Unit - Cyrillic (according to system language)
2 524 204 Fuse, 5 x 20 mm, T 2 A
2 (or) 717 150 Fuse, 5 x 20 mm, T 4 A (according to line voltage)
2 528 129 Fuse, 5 x 20 mm, T 6.3 A
2 503 126 Fuse, 5 x 20 mm, T 8 A (according to line voltage)
2 481 033 Remote control cable for Video printer
1 862 169 Coaxial cable (75, BNC/BNC, L = 2 m)
1 481 076 VCR cablea
1 481 068 Footswitch
1 (or) 487 082E Integrated PC without frame-grabber boardb
1 487 082OE Integrated PC with frame-grabber boardc
1 487 341 External PC Monitorb,c
1 487 163 USB cable (A/BM/M 15 Pts, L = 1.8 m)b,c,d
1 485 519 SIGMA/ORION VIDEO Cablec
1 487 376 PC Keyboard, QWERTY 86 Keysb,c
3 487 309 Keyboard Label "CTRL-ALT-ALTGR"b,c
3 487 368 Keyboard Label "CAPS-DEL"b,c
1 487 724 Allen key N°6 b,c
1 410 713 CEE22 socket male 2x10A + Tb,c
2 471 059 Air filter
1 426 016 Quality Control form

Table 2-2: Supplying list for SIGMA330 Expert and SIGMA 330 Excellence
a. when CFM option is installed on SIGMA 330 systems
b. for SIGMA 330 Excellence without frame-grabber board
c. for SIGMA 330 Excellence with frame-grabber board
d. when USB-Link™ option is installed

10.12.01 INSTALLATION 2-5

2.5 Transport
‰ For transport, SIGMA 110 and SIGMA 330 equipments must be placed in their original
package provided at their delivery.
‰ Peripherals must be placed in their original package provided at their delivery.
‰ Before carrying the SIGMA 330 Expert or SIGMA 330 Excellence unit, follow these instruc-
tions:
1. Disassemble the upper part (Monitor) which is attached on the top of the cart.
2. Remove the flat screen attached on the side of SIGMA 330 Excellence.
3. Remove the integrated computer from SIGMA 330 Excellence

2-6 SIGMA 110/SIGMA 330 10.12.01

2.6 Installation of SIGMA 330 Expert and SIGMA 330 Excel-
lence
2.6.1 Installation of the integrated cart
After unpacking, to assemble the SIGMA 330 Expert or SIGMA 330 Excellence unit:
‰ place the upper part on the cart

‰ connect the following cables :

1. Reference 412 139: power cable (labelling: ECHOGRAPHE)

2. Reference 411 353: mains cable
3. Reference 481 068: Footswitch
For connecting the other cables, see Chapter 2.9, “Connection of Peripherals”, on
page 2-15.
‰ fasten the two milled screws 1 inside the cabinet dedicated to VCR (Front view), see fig-
ure 2-1, “Installation of SIGMA 330 Expert or SIGMA 330 Excellence”, on page 2-7

Figure 2-1 : Installation of SIGMA 330 Expert or SIGMA 330 Excellence

10.12.01 INSTALLATION 2-7

2.6.2 Installation of the flat panel monitor
After unpacking, to assemble the monitor on the unit:
‰ place the monitor on its holder and tighten the screw 1 .

‰ make firm the cables with both cable fasteners 2 .

‰ connect the following cables:

1. Reference 487155: VGA monitor cable (for SIGMA 330 Excellence) 3

Reference 485659: signal monitor cable (for SIGMA 330 Expert)
2. DC power cable 4

2 1

Figure 2-2: Installation of the flat panel monitor

2.6.3 Installation of the integrated compact PC (SIGMA 330 Excellence only)

After unpacking, to assemble the PC into the cart:
‰ Mount both supports on the right and left side of the PC; use the M5x6 screws mounted on
the PC
‰ Remove the lower panel from the lower compartment of the cart with screwdriver Pozidriv
N°6
‰ Place the PC in the lower compartment and connect the following cables (see figure 2-3,
“Integrated PC (rear panel)”, on page 2-9):
1. Reference 487163: USB cable between PC and USB connector of SIGMA 330 Excel-
lence. 1
2. Reference 487163: USB cable between PC and your USB Hub or your USB periph-
eral (if any) 2
3. Reference 485519: Matrox Orion Video cable between PC and "COLOR PR/MONI-
TOR" connector of SIGMA 330 Excellence (only necessary for the 487082OE PC) 3
4. Reference 487155: VGA Monitor Cable between PC and Flat 15" Monitor:
4 for the 487082E PC and 5 for the 487082OE PC.

5. AC power cable to PC 6

2-8 SIGMA 110/SIGMA 330 10.12.01

 6. Reference 487775: DC power cable to Monitor 7
7. Ethernet Network cable (if necessary) 8
8. FireWire (IEEE-1394) cable to FireWire magneto-optical disk drive 9
9. Reference 488364: AC power cable to FireWire magneto-optical disk drive 10
‰ Connect the small PS/2 PC keyboard to the PC 11
‰ Push the PC at the bottom of the compartment (see figure 2-4)
‰ Wind up the panel again (see figure 2-4)

6 10 5 3 9 11 7

Figure 2-3: Integrated PC (rear panel)

Figure 2-4: Integrated PC (front view mounted in the cart)

10.12.01 INSTALLATION 2-9

2.7 Power Source Connection
2.7.1 Input Power Source
The SIGMA 110 and SIGMA 330 instruments are designed to operate on single phase line sup-
ply.
The unit is automatically grounded via the power cable, provided a 3 pin wall socket with a
grounded third pin is used.

2.7.1.1 SIGMA 110 Light/Master and SIGMA 330 Master

FUSES
MAINS VOLTAGE
Rating Type
100 - 127 V ~ T4A 5 x 20 mm
200 - 240 V ~ T2A 5 x 20 mm

Table 2-3: Line voltage/Fuses rating for SIGMA 110 Light/Master and SIGMA 330 Master

RATED INPUT POWER RATED FREQUENCY

340 VA / 100 - 127 V ~ 50 & 60 Hz
340 VA / 200 - 240 V ~ 50 & 60 Hz

Table 2-4: Power/Frequency rating for SIGMA 110 Light/Master and SIGMA 330 Master

Check that the selected voltage range corresponds to local power line voltage.
See figure 1-12, “SIGMA 110 Light, Master and SIGMA 330 Master rear panel”, on page 1-26 to
locate fuses.

2.7.1.2 SIGMA 330 Expert and SIGMA 330 Excellence

FUSES
MAINS VOLTAGE Rating
Type
Top Bottom
100 -127 V ~ T4A T8A 5 x 20 mm
200 - 240 V ~ T 2A T 6.3 A 5 x 20 mm

Table 2-5: Power/Frequency rating for SIGMA 330 Expert/Excellence

RATED INPUT POWER RATED FREQUENCY

680 VA / 110 - 127 V ~ 50 & 60 Hz
680 VA / 200 - 240 V ~ 50 & 60 Hz

Table 2-6: Power/Frequency rating for SIGMA 330 Expert/Excellence

2-10 SIGMA 110/SIGMA 330 10.12.01

The "top" fuses, located at the top part of the instrument are dedicated to electronic cabinet.
The "bottom" fuses, located at the bottom are dedicated to the complete SIGMA 330 Expert and
SIGMA 330 Excellence power supply including electronic cabinet and power output for peripher-
als.
See figure 1-10, “SIGMA 330 Expert rear panel”, on page 1-23 to locate fuses.

2.7.2 Output Power Source

SIGMA 330 Expert and SIGMA 330 Excellence include three auxiliary mains outlets to supply
some peripheral units, such as VCR, Printers and other peripherals, plus another one to supply
the Electronic Cabinet. (See Chapter III.2.1, “Electrical Safety”, on page -xix)
Power voltage supplied by the auxiliary mains is the same as local power line.
Before connecting a peripheral to the SIGMA 330 power output, be sure that its voltage range
corresponds to the local power line voltage and its consumption fits with the output rating for
peripherals.

MAX. CONTINUOUS OUTPUT

MAINS VOLTAGE
RATING for PERIPHERALS
100 - 127 / 200 - 240 V ~ 340 VA

Table 2-7: Output Voltage/Power rating

CAUTION
When the SIGMA 330 System includes more than three peripherals (or must provide more
than 340 VA), the additional peripherals must be supplied through a medical grade isolat-
ing transformer. Never connect them directly to wall outlets.
(See Chapter III.2.1 , Þ
Electrical Safetyß, on page -xix)

10.12.01 INSTALLATION 2-11

2.8 Connecting a Probe
2.8.1 SIGMA 330 Expert and SIGMA 330 Excellence Probe Assignment

P2

P3

P4

P6

P5

Figure 2-5: SIGMA 330 Expert/Excellence probe assignment

Both "P-2" and "P-3" ports, dedicated to Annular Sectorial probes (AS), the "P-4" port to Doppler
pencil probes and the "P-5" and "P-6" ports to Linear/Convex probes, are assigned in the probe
menu as shown in figure 2-5, “SIGMA 330 Expert/Excellence probe assignment”, on page 2-12
and in Chapter 3.5.2.2, “Probe Main Menu, with Two Linear Probes”, on page 3-12.

2-12 SIGMA 110/SIGMA 330 10.12.01

2.8.2 SIGMA 1 1 0 Light/Master and SIGMA 330 Master Probe Assignment

P1

P2

P3

P4
Figure 2-6: SIGMA 110 Light/Master and SIGMA 330 Master probe assignment

The "P-1" port, dedicated to Linear/Convex probes, both "P-2" and "P-3" ports to Annular Secto-
rial probes (AS) and the "P-4" port to Doppler pencil probes are assigned in the probe menu as
shown in figure 2-6, “SIGMA 110 Light/Master and SIGMA 330 Master probe assignment”, on
page 2-13 and in Chapter 3.5.2.1, “Probe Main Menu, with One Linear Probe”, on page 3-12.

2.8.3 Probe Connection

To connect or change a LINEAR/CURVE PROBE, insert the probe connector, cable side down,
into the probe socket. Rotate the connector lock handle 1/4 turn clockwise to lock the connector
in place.

Figure 2-7: Connecting a Linear/Curve Probe

10.12.01 INSTALLATION 2-13

To disconnect probe, rotate the lock handle 1/4 turn counter clockwise and pull the probe con-
nector away from the socket.

Figure 2-8: Disconnecting a Linear/Curve Probe

To connect a SECTOR/PENCIL PROBE, align the red point side up and push the probe connec-
tor in the socket.

Figure 2-9: Connecting a Mechanical Probe

.
Never connect or disconnect probe in live mode. When system operates in live
mode, press the FREEZE key before connecting or disconnecting probe.

2-14 SIGMA 110/SIGMA 330 10.12.01

2.9 Connection of Peripherals
2.9.1 Electrical safety with peripherals
The peripherals should be marked with CE identification mark and be in compliance with IEC 950
or IEC 601-1 Standards.

2.9.1.1 SIGMA 330 Excellence

‰ All equipments (printers, video recorders, external TV monitors and other peripherals)
should be connected to the three isolated outputs provided by the system or powered
through a medical grade isolating transformer when the system includes more than three
peripherals or their total consumption exceeds 340 VA.
Never connect additional peripherals directly to wall outlets; use the outlet availa-
ble in the cart or a medical grade isolating transformer which must comply with IEC
601 -1 specifications. Wrong connections may compromise the electrical safety of
the system. KONTRON MEDICAL provides a medical grade isolating transformer on
request, see Chapter 6.3, Þ Accessoriesß, on page 6-5 for ordering.
‰ RJ -45 Network Isolator must be used for connecting the system to network.
Never connect Network (RJ-45) directly to the system; use a medical grade network
isolator which must comply with IEC 601 -1 specifications. Wrong connections may
compromise the electrical safety of the system. KONTRON MEDICAL provides a
medical grade isolator on request, see Chapter 6.3, ÞAccessoriesß, on page 6-5 for
ordering.

2.9.1.2 SIGMA 330 Expert

‰ All equipments (printers, video recorders, external TV monitors and other peripherals)
should be connected to the three isolated outputs provided by the system or powered
through a medical grade isolating transformer when the system includes more than three
peripherals or their total consumption exceeds 340 VA.
Never connect additional peripherals directly to wall outlets; use the outlet availa-
ble in the cart or a medical grade isolating transformer which must comply with IEC
601 -1 specifications. Wrong connections may compromise the electrical safety of
the system. KONTRON MEDICAL provides a medical grade isolating transformer on
request, see Chapter 6.3, Þ Accessoriesß, on page 6-5 for ordering.

10.12.01 INSTALLATION 2-15

2.9.1.3 SIGMA 110 Light/Master and SIGMA 330 Master

‰ All equipments (printers, video recorders, external TV monitors and other peripherals)
should be powered through a medical grade isolating transformer or connected via appro-
priate isolating accessories.
KONTRON MEDICAL provides the following isolating devices on request:

Peripheral/Option Dedicated isolator/Isolating transformer

B&W video Printer BNC Video Isolation Amplifier (ref. 488550)
Colour Video Printer Isolation Transformer
VCR S-Video Isolator (ref. 488542)
Parallel printer/ EasyPrint™ Printer Port Isolator (ref. 489859)
Colour repetition monitor Isolation Transformer
Colour flat panel repetition monitor S-Video Isolator (ref. 488542)
USB-Link™ Isolation Transformer

‰ When no dedicated isolating accessory is available, the Isolation Transformer must be

used.
‰ KONTRON MEDICAL provides a medical grade isolating transformer and isolating acces-
sories on request, see Chapter 6.3, “Accessories”, on page 6-5 for ordering.
• Maximum power of Isolation Transformer is 750 VA. Sum of power of the different
peripherals connected to the Isolation Transformer must be less than 475 VA (ultrasound
system requires less than 275 VA).
• Isolation Transformer is recommended when two or more isolators are required for cost
and cabling reasons.
Never connect additional peripherals directly to wall outlets if no medical grade iso-
lating device provides a galvanic isolation between the peripheral and the ultra-
sound system. Use a medical grade isolating transformer which must comply with
IEC 601 -1 specifications. Wrong connections may compromise the electrical safety
of the system.
(See also, Chapter III.2.1, “Electrical Safety”, on page -xix)
It is recommended to turn the system OFF before connecting any peripheral.

2-16 SIGMA 110/SIGMA 330 10.12.01

2.9.2 Recommended Peripherals
The following peripherals are recommended for use in SIGMA 110/330 Systems:
‰ Black & white Video Printer

• MITSUBISHI P91E
• SONY UP890MD
• SONY UP895MD
‰ Colour Video Printer

• MITSUBISHI CP700E
• SONY UP-2300
‰ S-VHS Video Cassette Recorders

• PANASONIC SVHS AG MD830E (PAL 220 V)

• PANASONIC SVHS AG MD830 (NTSC 110 V)
• SONY SVO-9500MDP
‰ Parallel Printer

Parallel printer compatible with PCL level III language:

• HEWLETT PACKARD Deskjet 930C
• HEWLETT PACKARD Deskjet 970Cxi
• HEWLETT PACKARD Deskjet 990Cxi
‰ External colour Monitor

• Eye Q 300M, flat 15" TFT colour monitor

• CABEL C34N48X15H90A
• SONY PVM-14M2MD or equivalent
A standard B & W VCR (PAL or NTSC) and an external standard B & W monitor (PAL or NTSC)
can be connected to the SIGMA 330 and SIGMA 110 systems.
For using any other peripherals than those above mentioned, please contact your local service.
To get more information for using these peripherals, consult their proper user’s manual.

2.9.3 Archiving on Personal Computer

Archiving of digitized ultrasound images can be performed from SIGMA 110/SIGMA 330 systems
to Personal Computer via PCMCIA Memory Cards.
‰ PCMCIA reader
The recommended PCMCIA reader for PC is: SCM MICROSYSTEMS SWAPBOX SBI-D2P

10.12.01 INSTALLATION 2-17

2.9.4 Connection of B&W Video Printer
The black & white video printer must be connected to B/W output of the SIGMA 110/SIGMA 330.
This configuration is recommended for the MITSUBISHI P91 Black & White video printer:

1 2

Black & White

VIDEO PRINTER

Figure 2-1 0: B & W Video Printer Connection

1. Reference 481 033: Remote control cable for Video Printer

2. Reference 862 169: Signal cable for Video Printer
For optimizing the printout image quality, set the DIP SWITCH and the control panel configura-
tion on P91 video printer:

DIP SWITCH: CONTROL PANEL:

IMP : 75 Ohms BRT :0
: HIGH (when ext. monitor) CONT :5
N-TRAP : OFF Gamma :1
P-TRAP : OFF Print size : SCa
IMAGE : POSI
AFC : OFF
DIR : REVb
MEMORY : FRAME
SCAN : UNDER (NTSC)
: OVER (PAL)
SAVING : OFF
PAPER : HDc
a. SC setting is the largest print format.
b. REV is for printing the first image on top of a paper stream.
c. For best print results use only K65HM paper.

2-18 SIGMA 110/SIGMA 330 10.12.01

2.9.5 Connection of Colour Video Printer
The colour video printer must be connected to the colour video output of the SIGMA 330 sys-
tems. This configuration is recommended for the MITSUBISHI CP700E colour video printer:

1 2

Colour
VIDEO PRINTER

Figure 2-1 1 : Colour Video Printer Connection

1. Reference 481 033: Remote control cable for Colour Video Printer
2. Reference 479 764: Signal cable for Colour Video Printer

10.12.01 INSTALLATION 2-19

2.9.6 Video Recorder (VCR)
SIGMA 110 and SIGMA 330 systems include a Super-VHS interface which allows the user to
perform high quality record with S-VHS system. Any PAL or NTSC compatible VCR’s can be con-
nected to SIGMA 110 and SIGMA 330.
The VCR output can be configured at the factory to either S-VHS or VHS standard.

2.9.6.1 S-VHS VCR

The system features one VCR socket for S-VHS video input and output with sound.

S-VHS VCR

Figure 2-1 2: Connection of "S-VHS" VCR

1. Reference 481 076: integrated signal cable for S-VHS VCR

The recommended "S-VHS" VCR is PANASONIC AG-MD830E.

This recorder includes a "S-VHS AUTO/OFF" selector on its front panel. Set this selector AUTO
for S-VHS operation.
To obtain the best performances use Super VHS Video Cassettes.The switch "MODE LOCK"
have to be set to "OFF". The switch "Hi-Fi/NORM" must be set to "Hi-Fi".

2-20 SIGMA 110/SIGMA 330 10.12.01

2.9.6.2 VHS VCR

The system features one VCR socket for VHS video input and output with sound.

VHS VCR

Figure 2-1 3: Connection of "VHS" VCR

1. Reference 487 252: integrated signal cable for VHS VCR

2.9.6.3 Black & White VHS VCR

A Black & White VHS VCR can be connected to S-VHS VCR output using an adapter:

Black & White VHS to S-VHS

VCR ADAPTER

Figure 2-1 4: Connection of "VHS" VCR on S-VHS output

1. Reference 481 076: integrated signal cable for SVHS VCR

2. Reference 468 434: VHS to S-VHS adapter

10.12.01 INSTALLATION 2-21

2.9.7 ECG Module
The optional ECG Module can be coupled to SIGMA 110 and SIGMA 330 systems via the COM1
port located on the rear connector panel.
The ECG Module includes an ECG signal amplifier for displaying the trace on the video screen
and a QRS detector for synchronizing the 2D image.
The ECG Module is not intended for electrocardiography or monitoring use.
Nevertheless, its isolated input is protected against the effects of a defibrillator and classified as
"Type CF".

Black: Right Leg

Yellow: Left Arm

ECG Module
(483 281) Red: Right Arm

Figure 2-1 5: Connection of ECG Module

The figure 2-15 shows the connection of the ECG Module to SIGMA 110/330.
The patient cable must be connected to the patients right arm (Red), left arm (Yellow) and right
leg (Black) by means of the included ECG electrode clamps or by clipping it to disposable ECG
electrodes.

2-22 SIGMA 110/SIGMA 330 10.12.01

2.9.8 Colour Monitors

2.9.8.1 Connection of Colour Monitors

SIGMA 330 features an output port dedicated for an additional video monitor.
The following configurations are shown in figure for recommended colour monitors.

3 2 1

Additional
Colour Monitor

Flat Panel
Colour Monitor
EYE-Q 300M

Figure 2-1 6: Connection of additional Colour Monitor

1. DC power Input (12 V) for EYE-Q 300M

2. Reference 485 659: signal cable for EYE-Q 300M
3. Reference 485 861: signal cable for CABEL
Reference 479 764: signal cable for SONY PVM-14M2MD or equivalent

10.12.01 INSTALLATION 2-23

2.9.8.2 Settings for Flat Panel Monitor EYE-Q 300M

For optimizing the image quality, the following settings are recommended and set in factory:
EYE-Q 300M
OSD Settings
(VGA/S-VHS Settings)
Contrast 68
Luminosity Back Light 7
Brightness 95
Size Mode variable
Red 51
Colour Coordinates Green 56
Blue 57
Colour Resolution High
INTL Yes
Video Mode VTR VTR
IN3 S-Video
Saturation 50
Colour Control
Hue 55

Table 2-8: Settings for Flat Panel Monitor EYE-Q 300M

The Luminosity setting (Contrast, Back Light and Brightness) should be set by the user, in
accordance with environmental conditions.
In the Setting Mode (OSD = On Screen Display) the settings can be made using the operating
keys 1 .

Figure 2-1 7: Colour Monitor EYE-Q300M

2-24 SIGMA 110/SIGMA 330 10.12.01

2.9.9 Black & White Monitor
SIGMA 110 and SIGMA 330 feature output port dedicated for an additional video monitor.
Use only 75 Ohm (not 50 Ohm) coaxial cables to connect the external monitor.
If the monitor includes UNDERSCAN/OVERSCAN option, choose OVERSCAN for PAL standard
and UNDERSCAN for NTSC.

2 1

Black & White

VIDEO PRINTER Black & White
1
MONITOR

Figure 2-1 8: Connection of B & W monitor with Video Printer

1. Reference 862 169: Signal cable for Monitor and Video Printer (BNC/BNC, 75 Ohm)
2. Reference 481 033: Remote control cable for Video Printer/ECG

Black & White

MONITOR

Figure 2-1 9: Connection of B & W monitor

1. Reference 862 169: Signal cable for Monitor (BNC/BNC, 75Ohm)

10.12.01 INSTALLATION 2-25

2.9.1 0 Printer
An optional Parallel Printer can be coupled to SIGMA 110 and SIGMA 330 systems via
PRINTER output located on the rear connector panel.
It is recommended to use a standard cable 1 (length should not exceed 2 meters).
The printer must comply with Hewlett Packards PCL level 3 printer language.

Line Printer

Figure 2-20: Connection of Line Printer

The recommended printers are HEWLETT PACKARD Deskjet 930C, Deskjet 950C, Deskjet
990Cxi and 9xx series. For these printers, a parameter set can be saved by the system.

2.9.10.1 Printer settings

The user preferences for the printer are available from the second page of the Preference Sys-
tem Menu:
SETUP > Prefs > System.

DEPTH Printer Foot

page 2 Encoder Setup Pedal

2-26 SIGMA 110/SIGMA 330 10.12.01

When “Printer Setup” key is pressed (F2 key), the following screen is displayed:
14/02/01 08:30:31
GENERAL
Images per page: 1 √2 Background color: √White
3 4 As is
5 6
Paper size: √A4
Font type: Courier US Letter
√Times
Univers Paper type: √Plain
Glossy
Print borders: √Yes No Transparency

Print head/foot: √Yes No Background printing:√Yes No

Header
General Gamma Default
& Footer

The button “General” (F1 key) is automatically selected and general printer parameters are dis-
played. The selection of a parameter is easy: the cursor is placed on a field of interest, the corre-
sponding text is display in inverse video. This field is selected using the up left trackball key: a tick
mark is displayed in front of it. Note that only one parameter can be selected in a group (paper
size, paper type,...). The different groups are explained below.
Once all the desired parameters are chosen, the user selection is validated by leaving the
“Printer Setup” menu with ESC. The NoVRAM is then updated.
The “Default” key restores the default values and stores them in the NoVRAM. The default values
are given in the following sections.
‰ General Parameters

• Images per page

This parameter selects the number of images to be displayed on a page. The size and the posi-
tion are optimized in order to maximize the image size.
Available values: 1, 2, 3, 4, 5 and 6 images per page
Default value: 2 images per page

10.12.01 INSTALLATION 2-27

The following page layouts are defined:

Mr. Samuel JONES Andrews Hospital Mr. Samuel JONES Andrews Hospital Mr. Samuel JONES Andrews Hospital

B C
Image Title
Image Title
A

Image Title B C C
Image Title Image Title
Image Title
Kontron Medical layout1 page 1 Kontron Medical layout2 page 1 Kontron Medical layout3 page 1

Mr. Samuel JONES Andrews Hospital Mr. Samuel JONES Andrews Hospital Mr. Samuel JONES Andrews Hospital

C C C
C C
Image Title Image Title Image Title
Image Title Image Title

C C C C
Image Title Image Title Image Title Image Title
C C
C C C C
Image Title Image Title
Image Title Image Title Image Title Image Title

Kontron Medical layout4 page 1 Kontron Medical layout5 page 1 Kontron Medical layout6 page 1

Figure 2-21 : Predefined page layouts

These layouts are available with both A4 and US letter formats.

A: Image size 16.8 cm x 12.7 cm.
B: Image size 11.2 cm x 8.5 cm.
C: Image size 8.4 cm x 6.4 cm.
• Font Type
Available values: Courier, Times, Univers.
Default value: Times
• Print Borders
This parameter displays a black border around each image.
Available values: yes and no.
Default value: yes
• Print Head/Foot
This parameter displays a header and a footer on each page.
Available values: yes and no.
Default value: yes
• Paper color

2-28 SIGMA 110/SIGMA 330 10.12.01

This parameter selects the way the background has to be displayed. The background can be dis-
played in white or as is, i.e. as saved on the flash card.
Available values: “white” and “as is”
Default value: white
• Paper Size
Available values: A4 and US letter.
Default values: A4 for PAL video systems and US letter for NTSC video systems.
• Paper Type
Available values: plain, glossy and transparency
Default value: plain
• Background process
This parameter manages the print task. If the user selects yes, he can use the SIGMA normally
but print process will take more time, else the SIGMA is no more available during the printing.
Available values: yes and no.
Default value: yes
‰ Header & Footer

When “Header & Footer” is pressed (F2 key), the following screen is displayed:
14/09/00 08:30:31
HEADER

####LEFT #####CENTER ######RIGHT Date and time

ROW1: $Laboratory $Operator ##$DateAndTime Laboratory
Patient Name
ROW2: $PatientName •••••••••••••••• ••••••••••••••• Physician
Operator
ROW3: •••••••••••••• •••••••••••••••• ••••••••••••••• Page number
FOOTER

#LEFT #CENTER RIGHT

ROW1: ••••••••••••••• ••••••••••••••• •••••••••••••••
ROW2: ••••••••••••••• ••••••••••••••• •••••••••••••••
ROW3: $System ••••••••••••••• ####$PageNumber

Header
General Gamma Default
& Footer

Three lines are reserved for the header, three others are for the footer. On each line, three places
are available: right aligned, centred or left aligned.
A popup menu is displayed on the right side of the screen. It contains the name of some prede-
fined system variables: date and time, operator,...
The user may select one of these “system variables” to place it in any field.
Note that the KONTRON MEDICAL copyright and the system type are printed left aligned on the
third line of the footer (Cf. § • Copyright and System values on page 2-30). This field cannot be
neither moved nor deleted.
• Definition of the header and footer

10.12.01 INSTALLATION 2-29

The definition of the footer and header is equivalent:
Using the trackball, the user selects a location. The selected field is displayed in inverse video.
Now, if the user presses the backspace key the selected field is deleted,
Else, if he presses the “Enter” key or the up left trackball key the edition mode is turned on.
In edition mode, the user can select predefined variables from the popup menu.
The “Enter” key or the up left trackball key validates then the definition of the field.
Note that the ‘$’ character is used as a leading character for predefined variables name.
These steps must be fulfilled for each field to print in the footer or in the header.
When all the relevant fields are defined, the user saves its work by leaving the “Printer Setup”
menu. These fields are then stored in NoVRAM and retrieved each time the system is started.
If the user presses the “Default” key, the default values are restored. Default values are defined in
the figure above.
• Copyright and System values
The $System parameter describes:
the KONTRON MEDICAL mark
the system type: SIGMA 110, SIGMA 330, ...
and is defined in the following way:
the text is:
“SIGMA 330, KONTRON MEDICAL” for a SIGMA 330 system
“SIGMA 110, KONTRON MEDICAL” for a SIGMA 110 system
the text must be discreet, and so it will be displayed using a special font style (italic).
Note: The user cannot delete the system variable.
• Variables deletion
The user can delete a variable by pressing the <SPACE> key or the <BACKSPACE> key.

2-30 SIGMA 110/SIGMA 330 10.12.01

 ‰Gamma
When “Gamma” is pressed (F3 key), the following screen is displayed:
14/09/00 08:30:31
Gamma

Contrast : 0 (-5..+5)
Brightness : 0 (-5..+5)

Header
General Gamma Default
& Footer

From here, the user can tune the printers gamma and correct the output image. The user can
change both contrast and brightness. He saves its setup by leaving the “Printer Setup” menu.

10.12.01 INSTALLATION 2-31

2.9.1 1 Connection with medical grade isolators
When required, KONTRON MEDICAL can provide medical grade isolators on request. In case of
doubt, for more details to connect additional peripherals contact your local distributor.
See also, Chapter III.2.1, “Electrical Safety”, on page -xix and Chapter 2.9.1, “Electrical safety
with peripherals”, on page 2-15.

Printer Port 2
Isolator PC Printer
489859

AC/DC
110/220 VAC

110/220 VAC

Figure 2-22: Connection with isolating accessories

1. Reference 490 199: Cable DSUB 25 M/F, L = 1.5 m

2. Reference 870 072: Cable PC/Printer, L = 1.8 m

2-32 SIGMA 110/SIGMA 330 10.12.01

2.9.1 2 Connection with S-Video Distributor
When required, KONTRON MEDICAL can provide medical grade isolators on request. In case of
doubt, for more details to connect additional peripherals contact your local distributor.
See also, Chapter III.2.1, “Electrical Safety”, on page -xix and Chapter 2.9.1, “Electrical safety
with peripherals”, on page 2-15.

110/220 VAC
1

VHS/S-VHS VCR S-VHS

Adaptor
S-VIDEO 489689
Distributor
490024
LCD Flat Panel 2
Repetition Monitor
AC/DC
AC/DC

110/220 VAC 110/220 VAC

Figure 2-23: Connection with isolating accessories

1. Reference 481 076: signal cable for S-VHS VCR

2. Reference 441 562: S-VHS signal cable for EYE-Q 300M

10.12.01 INSTALLATION 2-33

 This page is intentionally left blank

2-34 SIGMA 110/SIGMA 330 10.12.01

 3. OPERATING INSTRUCTIONS

10.12.01 OPERATING INSTRUCTIONS 3-1

3-2 SIGMA 110/SIGMA 330 10.12.01
3.1 Operating Precautions
If the SIGMA 110/330 is being plugged in for the first time, refer to Chapter 2.7, “Power Source
Connection”, on page 2-10.
Connect the mains inlet connector to a suitable supply source.
Make sure that the power line supply complies with the voltage selected on SIGMA 110/330.
Be certain that the power source receptacle is a 3 pin socket with the third pin grounded.

Note:
The unit can be connected to the patient's bed by using the equalization potential terminal (Chas-
sis Ground); see figure 1-10, “SIGMA 330 Expert rear panel”, on page 1-23.

Check the connections of transducers, auxiliary and optional equipment, such as recorders
(VCR), printers and other peripherals.
Make sure that connections are properly and securely made and that cables and connectors are
in good condition:
• Cables free of unnecessary stress or friction for the length of the cable.
• Cables covering and insulation undamaged.
• Connectors secured at the cable end and matching securely at connection.

10.12.01 OPERATING INSTRUCTIONS 3-3

3.2 Switching the Instrument ON
3.2.1 Switching ON SIGMA 1 1 0 and SIGMA 330 Master
The power ON/OFF sequence consists of 3 states: Instrument OFF, STAND-BY, ON.
To switch the instrument ON:

1.Push the ON/OFF power switch on the rear panel of SIGMA 110 (see figure 1-12,
“SIGMA 110 Light, Master and SIGMA 330 Master rear panel”, on page 1-26).
The green power indicator lamp, located in front of the control panel, will blink.
This light shows that the system is in wait state.
2. When the power indicator lamp blinks, press the ON/OFF key on the keyboard or on the
remote control.
A beep sounds when the program enters the start-up procedure. The green power indicator
lamp, located in front of the control panel, illuminates.The initialization sequence starts, see
Chapter 3.2.4, “Initialization of SIGMA”, on page 3-5.

3.2.2 Switching ON SIGMA 330 Expert

The power ON/OFF sequence consists of 3 states: Instrument OFF, STAND-BY, ON.
To switch the instrument ON:

1.Push both ON/OFF power switches on the rear panel at the bottom and behind the mon-
itor of SIGMA 330 (see figure 1-10, “SIGMA 330 Expert rear panel”, on page 1-23).
The green power indicator lamp, located in front of the control panel, will blink.
This light shows that the system is in wait state.
2. When the power indicator lamp blinks, press the ON/OFF key on the keyboard or on the
remote control.
A beep sounds when the program enters the start-up procedure. The green power indicator
lamp, located in front of the control panel, illuminates. The initialization sequence starts, see
Chapter 3.2.4, “Initialization of SIGMA”, on page 3-5.

3.2.3 Switching SIGMA 330 Excellence ON

The power ON/OFF sequence consists of 3 states: Instrument OFF, STAND-BY, ON.
To switch the instrument ON:

1.Push both ON/OFF power switches on the rear panel at the bottom and behind the mon-
itor of SIGMA 330 (see figure 1-10, “SIGMA 330 Expert rear panel”, on page 1-23).
The green power indicator lamp, located in front of the control panel, will blink.
This light shows that the system is in wait state.
2. When the power indicator lamp blinks, press the ON/OFF key on the keyboard or on the
remote control.
A beep sounds when the program enters the start-up procedure. The green power indicator
lamp, located in front of the control panel, illuminates. The initialization sequence starts, see
Chapter 3.2.4, “Initialization of SIGMA”, on page 3-5.
The compact internal PC is automatically started, the Flat Panel Monitor is lighted (if not, press
the Power ON button) and "Starting up for Windows 2000 Pro" appears on the PC screen.

3-4 SIGMA 110/SIGMA 330 10.12.01

For operating SIGMA 330 Excellence or PC applications such as 3D Imaging, see Chapter 3.7.6,
“3D imaging”, on page 3-46 and Chapter 3.20, “Integrated PC (SIGMA 330 Excellence)”, on
page 3-110.

3.2.4 Initialization of SIGMA

After a short delay, the system displays the "welcome" screen:

SIGMA XXX
Printer
icon Version E5.XX

Doppler
icon VLCUS PRESENT (05.xx)
COL_DOP PRESENT (04)
CFM LINEAR PRESENT (05)
icon
SWITCH BOX PRESENT
CINE PRESENT
Iris SUBSI PRESENT (01)
icon
ECG PRESENT
VIDEO TYPE PAL
Cardio
icon KEYBOARD 2.10

Digital
Storage
icon

‰ SIGMA xxx displays the SIGMA type (110 Light, 110 or 330)
‰ The software version and the installed hardware are displayed
‰ SIGMA configuration icons:
Icon Description Icon Description
Iris icon means that the Iris
Displayed when Easy-
PrintTM option is available EHEI features and colour monitor
are available

Doppler icon means that the

Cardio icon means that the
Spectral Doppler features are
Cardio features are available
available
SP
CFM icon means that the
KIPRISM icon means the
Colour Doppler features (Col-
Digital Storage features are
our Flow Mapping) are avail-
CFM KIPRISM available
able

Displayed when USB-LinkTM

option is available

A "progress bar" indicates the machine is initialising.

Then the 2D image area and PROBE Menu are displayed (except when a user setup shows
another mode).

Note :
After turning the system off, always wait five to ten seconds before turning the power on again.

10.12.01 OPERATING INSTRUCTIONS 3-5

3.3 Switching the Instrument OFF
3.3.1 Switching OFF SIGMA 1 1 0 and SIGMA 330
To switch the instrument OFF, press the power ON/OFF key on the keyboard. The Power OFF
Menu is displayed:

Power Cancel
Off

• Press POWER OFF (F1) to confirm the current switching OFF sequence
• Press CANCEL to abort the current switching OFF sequence
This switching OFF sequence is designed to avoid switching OFF by mistake.
After the POWER OFF confirmation, the power indicator blinks and the instrument is in stand-by
mode.
With the remote control, the machine can be powered off immediately if the user presses the
POWER OFF button.
Press the power switch on the rear to completely switch the machine OFF.

Note:
When the instrument is not used for 10 minutes, the image automatically goes into frozen state.
Then, most function keys become inactive. A beep warns the user. Press FREEZE key to return
to previous mode.

3.3.2 Switching OFF SIGMA 330 Excellence

To switch the instrument OFF, press the power ON/OFF key on the keyboard. The Power OFF
Menu is displayed:

Power Cancel
Off

• Press POWER OFF (F1) to confirm the current switching OFF sequence
• Press CANCEL to abort the current switching OFF sequence
(This switching OFF sequence is designed to avoid switching OFF by mistake.)
• Select Shut Down on the PC dialog
• The system is automatically powered off
After the POWER OFF confirmation, the power indicator blinks and the instrument is in stand-by
mode.
Press the power switch on the rear to completely switch the machine OFF.

3-6 SIGMA 110/SIGMA 330 10.12.01

3.4 Menus
Menus are used to access functions or parameters. There is a specific menu for each mode, for
setups and for processing features settings (see mode selection chapters in Chapter 3.7, “Major
Modes”, on page 3-25).
The menus are displayed in gray.
The inside text is displayed in black if the menu button is selected and in white if not.

3.4.1 Notes
‰ The following syntax is used in this document to describe the formats:
[XX]/YY describes a dual format with pad XX being active.

3.4.2 Menu Key Conventions

As a general convention, the menu keys are always displayed in the same place independent of
the modes.
A menu key can be enabled, disabled or not available. If a menu key is disabled it is drawn
ghosted. If it is not available it is not drawn at all.
The following rules are used to distinguish between disabled and not available menu keys:
‰ If the functionality represented by the key is enabled in one mode but doesn’t work in an
other mode, the key is disabled in the other mode.
‰ If the functionality is never enabled in any mode, it is not available and so not displayed.
‰ Exceptions which will improve the user interface are introduced.

3.4.3 Menu Types

Two different types of menus can be displayed according to whether the current application is
single or double.
A Single Menu consists of one Menu Item row that can contain two character lines (see figure
1-16, “Single Menu Display”, on page 1-36).
A Double Menu consists of two Menu Item rows that contain one character line each (see figure
1-17, “Double Menu Display”, on page 1-37).

3.4.4 Menu Display

Note that the menu corresponding to the active mode is automatically displayed when the user
enter the mode.
The user can also press the PREVIOUS (<) or NEXT (>) keys to access in a circular fashion the
previous or next menu page (if more than one menu page exists in the current menu).

Note: the > symbol in the lower right corner of menu field M5, M10, M20,... is only displayed if
more than one menu page exists.

10.12.01 OPERATING INSTRUCTIONS 3-7

 M1 M2 M3 M4 M5

M6 M7 M8 M9 M10

M1 M2 M3 M4 M5

To hide (and disable) a menu, press the MENU key.

The menu is hidden during the print phase and displayed again when printing is finished.

3.4.5 Menu Items

There are two types of menu items: selectable and incremental.
Choosing a selectable menu item causes the action to be carried out immediately when the
‰
associated key is pressed.
‰ Choosing an incremental menu item dedicates the incremental potentiometer to the current
action when the associated key is pressed. The Ú Symbol is used to identify an incremen-
tal menu item (e.g. for Angle or Vector adjustment).
The related Function keys (F1 to F10) are used to select Menu Items (see figure 1-16, “Single
Menu Display”, on page 1-36 and figure 1-17, “Double Menu Display”, on page 1-37).

3.4.5.1 Selectable Menu Items

Selectable Menu Items

‰

The user only needs to press the associated function key to activate the action.
‰ Selectable menu items with toggle action

Toggle menu items have a different behaviour: the menu item string changes dynamically and
describes the next action to be performed when the button is pressed and not the state of the
system.
For instance: Up/Down image inversion in 2D mode is controlled by the 2D Inv. menu item as fol-
lows:

3-8 SIGMA 110/SIGMA 330 10.12.01

 Angle Dual Zoom Freq Biopsy1

2D Inv. Right Tilt AddFocus Trigg 1

Angle Dual Zoom Freq Biopsy1

2D Inv. Right Tilt AddFocus Trigg 1

Convention: Throughout this document toggle menu items contain the symbol "/", such as Left/
Right ..., but note that only Up or Down will be displayed at a given time.

3.4.5.2 Incremental Menu Items

Incremental menu items are associated with the adjustment of a parameter. The user presses
the associated function key to select the item and eventually adjusts (increments or decrements)
the parameter using the incremental potentiometer.
Turn the button clockwise to increase the parameter value and counter clockwise to decrease it;
when the minimum or maximum value is reached a beep warns the user.
For example to change the angle of 2D sector:

1. Select the Angle (F1) function key

2. Turn MP left or right to decrease/increase the scanning angle

10.12.01 OPERATING INSTRUCTIONS 3-9

 Angle Dual Zoom Freq Biopsy1
1.
2D Inv; Right Tilt AddFocus Trigg 1

2. 2
0

3-10 SIGMA 110/SIGMA 330 10.12.01

3.5 Probes
3.5.1 Probe Selection
Press the PROBE key to display the Probe Menu. This menu shows the names of the probes
that are connected to the system. Up to 5 probes can be simultaneously connected to SIGMA
330 Expert including Doppler function and SIGMA 330 Excellence, 4 probes for SIGMA 110 Mas-
ter and SIGMA 330 Master models including Doppler option; and 3 probes for the SIGMA 110
Light including Doppler option:
‰ Two Linear Probes (or Convex Linear Probes), one Doppler Probe (Pencil Probe) and two
AS probes for SIGMA 330 Expert and SIGMA 330 Excellence.
‰ One Linear Probe (or Convex Linear Probe), one Doppler Probe (Pencil Probe) and two
AS probes for SIGMA 1 1 0 Master and SIGMA 330 Master.
‰ Two Annular Sector probes and one Doppler probe (pencil probe) for SIGMA 1 1 0 Light.

The following drawing shows the probe menu with 4 probes connected. The probe which is
selected by default when switching the instrument on can be determined by the user via the
Setup menu. Pressing F2 softkey selects the probe connected to connector "P-3" (e.g. 5.0 GP).

P-2 P-3 P-4 P-1

3.5 GP 5.0 GP PEN 2 7.5 LV

When selecting Probe, the system looks for a setup for this probe. First priority search is user
setup; second priority search is factory setup.

3.5.2 Menu Display

The key corresponding to the current probe used is displayed pressed.
If a probe is not recognized by the system (bad ID), “Invalid Probe” is displayed instead of the
probe name and the key is disabled.
If a probe is recognized by the system but can’t be used (e.g. Pencil probe with no doppler
board), the probe name is displayed but the key is disabled.

10.12.01 OPERATING INSTRUCTIONS 3-11

3.5.2.1 Probe Main Menu, with One Linear Probe

P-2 P-3 P-4 P-1

AS 1 AS 2 PEN Linear 1

3.5.2.2 Probe Main Menu, with Two Linear Probes

(SIGMA with Switch Box)

P-2 P-3 P-4 P-5 P-6

AS 1 AS 2 PEN Linear 1 Linear 2

The recommended probes according to Medical Applications, are listed in the table i on page xvi.
The main features of the probes are shown in the table ii on page xviii.

3-12 SIGMA 110/SIGMA 330 10.12.01

3.6 Setup
This function allows the user to select factory or user setup parameters. Factory Setups are pre-
set by the Manufacturer and cannot be modified by user. User Setups are created by users and
can be modified, renamed and deleted. Each Setup is assigned to one probe and stores all the
user accessible parameters for all the scanning modes (2D, TM, ..., 2D + TM, ...), depending on
the dedicated application.

3.6.1 Setup Menu

Load Save Delete PCMCIA

page 1 Prefs
SETUP SETUP SETUP Card

System
page 2 Info

Press SETUP on the user interface to display the setup menu.

3.6.2 Loading a Setup

Press Load SETUP (F1) function key to select a dedicated setup of the current probe.
The System displays only the setups dedicated to the current probe, including the Factory Set-
ups.
The Factory setups are always displayed after the user setups.
User setups are displayed in upper case and factory setups in lower case.
At most 20 user setups can be defined for all probes. If more than 5 setups exist for the current
probe, a second page is added to the menu; each setup page is accessed by using PREVIOUS
(<) or NEXT (>) key.

USER USER USER USER

page 1 Radio
SETUP 1 SETUP 2 SETUP 3 SETUP 4

page 2 Vasc.

3.6.3 Saving a Setup

The user can save more than one setup for each probe and up to 20 setups for all probes.

To save a Setup:

1. Press SETUP key to enter SETUP menu.

10.12.01 OPERATING INSTRUCTIONS 3-13

 2. Press Save Setup (F2)
3. Press New Setup (F1)

New USER USER USER

Setup SETUP 1 SETUP 2 SETUP 3

4. Enter the new setup name using the alphanumeric keyboard

5. Validate with RETURN key
The sequence can be aborted at any time using the ESC key.
A new user setup has been created and stored in the system. It appears in the setup menu.
Press ESC key to return to previous menu. For renaming a setup, the user must select the setup
and save it again on itself. For saving, a new name is always requested.

3.6.4 Deleting a Setup

To delete a User Setup:

1. Press Delete Setup (F3). The Delete Setup Menu displays all user setups stored in the
system (for every probe and every application).
2. Select the setup to be erased with the corresponding function key. The confirmation
menu is displayed.
3. Answer Y (Yes) to confirm or C to cancel the erasing sequence.

3.6.5 Preferences
Press Prefs (F4) function key of SETUP menu to display the preferences menu.

Meas./
Date Display System Time
Biom.

3.6.5.1 Date

The system displays the date. According to the version PAL or NTSC, the date is automatically
displayed in a specific order:
• DD/MM/YYYY for the PAL version (DD: day, MM: month, YYYY: year)
• MM/DD/YYYY for the NTSC version (DD: day, MM: month, YYYY: year)

Using the Date menu the user can modify the current date of the system. The Date menu
includes Day, Month, Year, Validate and Abort keys:

3-14 SIGMA 110/SIGMA 330 10.12.01

 Day Month Year Validate Abort

To modify the day (e.g.):

1. Press Date (F1)

2. Press Day (F1)
3. Rotate the softpot to get the right day
4. Then press Validate (F4)
Proceed similarly for changing month and year.

3.6.5.2 Display

kHz Pt ID Off TecD Off Annot ScrnSave

Refr On ECG Off Time AFA Off Rent On

‰ Doppler scale: m/s or kHz

Doppler information can be shown in m/s or kHz. Use m/s / Hz (F1) function key to select
the desired scale.
‰ Patient Identification: On/Off
Patient Identification can be displayed on the screen. Use Pat ID (F2) function key to dis-
play or not the Patient Identification.
‰ Technical Data: On/Off
Technical Data can be displayed on the screen. Use TecD (F3) function key to display or
not the Technical Data.
‰ Annotation:

Erase annotation on Unfreeze

(preference is now Keep Annot)

Keep Annot Erase Annot

The annotations displayed on the screen are kept or erased when the display is unfrozen.
Choose between keep or remove annotations with the Annot key (F4). Press on the char-
acter corresponding to the first letter of the strings in the buttons.

10.12.01 OPERATING INSTRUCTIONS 3-15

 ‰ Screen Saver:

Screen saver’s settings

1.Off
2.10 minutes
3. 20 minutes
4. 30 minutes

Ok Cancel

With this dialogue box, the user can select the time until a screen saver will be started if the
machine is not used. By touching any key or the trackball the screen saver will be stopped.
The default value is off.
‰ Refresh: On/Off
Refresh function in Doppler and TM modes can be enabled or disabled. Use Refr (F6)
function key to enable or not this function. When it is on, 2D image is refreshed at the end
of each SP or TM sweep.
‰ Time

Time display

1. 24 hour clock

2. 12 hour clock

Ok Cancel

The user can select Time display on 24 hours or on 12 hours.

Default setting is 24 hours for PAL (ex: 14:50:36)
Default setting is 12 hours for NTSC (ex: 2:50:36 PM)
‰ AFA
Enables or disables the display of Automatic Frequency Adjustment marker in 2D.
‰ ECG: On/Off
ECG function can be enabled or disabled. When it is on, ECG trace is displayed on the
screen. Press ECG function key (F7) to toggle.
‰ Rent: On/Off (Time Renting option)
Enable or disable display of time renting informations.

3-16 SIGMA 110/SIGMA 330 10.12.01

3.6.5.3 Measurement and Biometry Preferences

Circumf. Line VTI LV Cardio

page 1
draw meas. study setup

page 2 Volumes

‰ Circumference

Circumference drawing
(preference is now Ellipse)

Ellipse Area.

In Obstetrics, the circumference measurements (Abdominal circumference and Head cir-

cumference) are made from either Ellipse or Area drawing. User can select either Ellipse or
Area in SETUP/Preferences menu using Circumf. (F1)
• Preference for Ellipse: circumference is computed from ellipse circumference.
• Preference for Area: circumference is computed from area contour.
Press the character corresponding to the first letter of the strings in the buttons to select
your option.
‰ Line draw: dashed line/no line

Line drawing on distance measurement

(preference is now Dash line)

Dash line No line.

Distance measurement can be initialized with two different types of drawing. User can
select either Dash line or No line in SETUP/Preferences menu, using Line draw (F2).
• Preference for Dash line: a dashed line is drawn between the two end points of the dis-
tance to be measured.
• Preference for No line: there is no line between the two points.
Press on the character corresponding to the first letter of the strings in the buttons to select
your option.

10.12.01 OPERATING INSTRUCTIONS 3-17

 ‰ LV Study: default mode for LV Study

LV Study setup for REPORT

(preference is now Full)

Full Abbr.

LV Study can be initialized in two different modes. User can select either Full LV-study or
Abbreviated LV-study with LV Study (F4) function key.
Press on the character corresponding to the first letter of the strings in the buttons to select
your option.
‰ VTI: default mode for VTI measurement

VTI measurement mode

(preference is now Auto.)

Auto. Manual

VTI measurement can be initialized either in Automatic or in Manual mode with VTI Meas.
function key (F3).
Press on the character corresponding to the first letter of the strings in the buttons to select
your option.
‰ Cardio setup:

Cardio new study start-up page

1. Left ventricle study

2. Mitral valve study
3. Aortic valve study
4. Right ventricle study

Ok Cancel

With this dialogue box, the user can select the page which is to be displayed each time a
new Cardio Study is displayed.
• Left Ventricle Study: Press alphanumeric key "1"
• Mitral Valve Study: Press alphanumeric key "2"
• Aortic Valve Study: Press alphanumeric key "3"
• Right Ventricle Study: Press alphanumeric key "4"
Press the character corresponding to the first letter of the strings in the buttons to validate
or cancel your action.

3-18 SIGMA 110/SIGMA 330 10.12.01

 ‰ Volumes
The standard Radiology Study REPORT page is displayed. The user can define the calcu-
lation type for the volume measurement.

3.6.5.4 System

Probe PRINT Config. Renting

page 1 KIPRISM
Select Select Key Key

Depth Printer Foot PCMCIA

page 2
Encoder Setup Pedal Card

‰ Probe Select: Probe selection at switching on.

The Dialogue box allows the user to determine which probe is selected when the system
starts.
At switching on, the system searches probes that are connected and starts with the one
that is selected in the dialogue box for probe preference.
• configuration with one Linear/Convex Probe:

Start looking for a probe on connector:

1. P-1 (Linear)
2. P-2 (Mech1)
3. P-3 (Mech2)
4. P-4 (Pencil)

Ok Cancel

• configuration with two Linear/Convex Probes:

Start looking for a probe on connector:

1. P-2 (Mech1)
2. P-3 (Mech2)
3. P-4 (Pencil)
4. P-5 (Linear1)
5. P-6 (Linear2)

Ok Cancel

Press on the character corresponding to the first letter of the strings in the buttons to validate or
cancel your option.

10.12.01 OPERATING INSTRUCTIONS 3-19

 ‰ PRINT Select
With the PRINT select key the user can assign the PRINT2 key of the keyboard and the
PRINT key on the remote control to following functions:

Assign PRINT2 key to

1. Nothing
2. Colour Video Printer
3. Archiving

Ok Cancel

• Nothing: PRINT2 key has no function (press alphanumeric key "1")

• Colour Video Printer: If PRINT2 is assigned to the Colour Video Printer, the key gener-
ates a remote signal for a colour video printer which can be attached only to SIGMA 330
systems (press alphanumeric key "2").
• Archiving: PRINT2 key acts as save key if KIPRISM is installed on the system and a for-
matted Flashcard is entered in the slot.
(press alphanumeric key "3")
The actual image is stored in memory by pressing the PRINT2 key. If the KIPRISM
option is enabled, the default action is set to the image storage.
In this case:
- The user can save images when the machine is in LIVE mode.
- a beep is generated if there is no space left on the memory card or if the flash
card system is not correctly formatted.
Press the character corresponding to the first letter of the strings in the buttons to validate
or cancel your action.
Then the next dialogue box appears:

Assign Remote Controller’s PRINT key to

1. Nothing
2. Black & White video printer
3. Colour video printer
4. Archiving

Ok Cancel

The functions are the same as for the PRINT2 configuration.

‰ Config. Key
The Config Key is used to enter the keywords that enable the EasyPrint options. These
keywords are provided by the factory.

3-20 SIGMA 110/SIGMA 330 10.12.01

 ‰ Renting Key
Press this key for entering new time renting credit to the system. These keywords are pro-
vided by the factory.
‰ KIPRISM
With the KIPRISM key the user can select a black background or a white background
when storing images on memory card.

Store images on flashcard with

1. Black background (as on screen)

2. White background (recommended
when printing on ink jet printer)

Ok Cancel

• Press alphanumeric key "1" to select a black background.

• Press alphanumeric key "2" to select a white background. This option is recommended
when printing on ink jet printer.
‰ Depth encoder
Depth encoder preference allows the user to select the sense of the DEPTH encoder:

Increase depth when turning

DEPTH encoder:
1. Clockwise
2. Counterclockwise

Ok Cancel

• Press alphanumeric key "1" to select "Clockwise" : turning the Depth encoder clockwise
increases depth.
• Press alphanumeric key "2" to select "Counterclockwise".
‰ Printer Setup
Press this key to display the screen for setting the printer parameters, see Chapter
2.9.10.1, “Printer settings”, on page 2-26.

10.12.01 OPERATING INSTRUCTIONS 3-21

 ‰ Foot Pedal
Foot Pedal allows the user to select the action associated to the left pedal of the footswitch.
The right pedal is always assigned to FREEZE/UNFREEZE.
Action associated to left
footswitch pedal:
1. Print
2. Image select

Ok Cancel

‰ PCMCIA Card
PCMCIA allows the user to select the option "Read only or Full access" for the PCMCIA
memory card..
Data stored on PCMCIA Card are:

1. Read only accessed

2. Full accessed
required for PACS

Ok Cancel

3.6.5.5 Time

The system displays the current time. Using the Time menu the user can modify the current time
of the system. The Time menu includes Hour, Minute, Second, Validate and Abort keys.

Hour Minute Second Validate Abort

To modify the hour (e.g.):

1. Press Time (F5)

2. Press Hour (F1)
3. Rotate the softpot to get the right hour
4. Then press Validate (F4)
Proceed similarly for changing minute and second.

3-22 SIGMA 110/SIGMA 330 10.12.01

3.6.6 PCMCIA CARD

Backup Restore List Format Battery

Config Config Content Check

The system offers the possibility of saving and restoring user configurations using a PCMCIA
memory card. This is very useful in case of multi-application and multi-user; each physician using
the system can get a personal memory card to store his configuration.

‰ Backup Configuration
The function key Backup Config (F1) backs up the user configuration (laboratory, operator
and physician names, Ob/Gyn setup and user reference tables, user probe setup and pref-
erences) on the memory card. This operation must be done periodically and before any
software update.
‰ Restore Configuration
The function key Restore Config (F2) restores the user configuration saved on the mem-
ory card and replaces the current settings with the restored ones.
‰ List Content
The function key List Content (F3) lists a summary of the memory card content: the labo-
ratory, operator and physician names and the probe setup names.
‰ Format
The function key Format (F4) formats the memory card for digital archiving of ultrasound
images.
‰ Battery Check
The function key Battery Check (F5) checks the battery charge level of the memory card.
The following messages are returned:
• BATTERY STATE: Full 100%, normal operating conditions
• LOW BATTERY: exchange the battery as soon as possible.
• EMPTY BATTERY: replace the battery immediately.

3.6.7 System Info

Boards Software Software Power on Key

page 1
version ext. ver stats historic

Time
page 2
Renting

The System Information Menu allows the user to display:

• installed boards and their version
• software version

10.12.01 OPERATING INSTRUCTIONS 3-23

 • extended software versions
• power on statistics
• key historic
• time renting information

3-24 SIGMA 110/SIGMA 330 10.12.01

3.7 Major Modes
SIGMA 110 can include four major imaging modes: 2D, TM, PW, CW (PW and CW are optional).
SIGMA 330 can include five or six major imaging modes: 2D, TM, PW, CW, CFM and additionally
3D on SIGMA 330 Excellence (CFM and 3D are optional).

3.7.1 2D Mode
Press 2D key to select 2D mode (see figure 1-4, “Keyboard”, on page 1-13 to locate the key).

Note
This mode is automatically set when the instrument is switched ON, if no personal setup has
been previously defined and if the probe which is automatically selected by the system is able to
do 2D.

3.7.1.1 2D Mode Selection

The legend used to identify the image state in the following pictures is shown below:

no ultrasound image

shading filling for live image

shading filling for frozen image

shading filling for refreshed image

this symbol shows the LEFT/RIGHT scanning direction

this symbol shows the selected image (live image or latest frozen image)

this symbol shows that image is frozen

trackball

Figure 3-1 : 2D Mode Selection

10.12.01 OPERATING INSTRUCTIONS 3-25

 Figure 3-2: Double 2D Selection

3-26 SIGMA 110/SIGMA 330 10.12.01

 Figure 3-3: Quad 2D Selection

10.12.01 OPERATING INSTRUCTIONS 3-27

3.7.1.2 2D Live Menu

This menu is displayed in active 2D mode:

Angle Dual Zoom Freq Biopsy1

page 1
2D Inv. Right Tilt AddFocus Trigg 1

Gamma Smooth Enhance Reject

page 2
Rainbow TI

‰ Angle
This function allows the user to modify the angle of the image sector for Annular Sector
and Convex probes. Use the MP potentiometer to select the desired angle. For available
angles see table -ii, “Probe Features,” on page -xviii.
‰ Single/Dual/Quad
This function displays single, double and quad multi-format. Select Dual to display double
2D images, then select Quad to display quad 2D images and select Single to return to sin-
gle 2D image. In dual mode, press 2D to return to single 2D.
‰ Zoom: Panoramic Zoom for Annular Sector probes
Press Zoom to magnify an area of the ultrasound image. The trackball is used to select the
area to be enlarged by moving a window on the image; the magnified zone is displayed
beside the entire image. The softpot allows the image to be magnified by: 1.14 to 2.73. The
magnifying factor depends on image depth; it is displayed in the technical data area on the
right side of the screen. Press Single or turn the softpot counter clockwise to exit.
‰ Zoom: Scrolling Zoom for Linear/Convex probes
Press Zoom to magnify an area of ultrasound image. The trackball is used to move the
enlarged area on the initial image, in the image depth direction; only the magnified zone is
displayed. A Zoom Range Indicator is displayed on the left of the 2D Zoom Menu to locate
the current enlarged area. For instance, the drawing below shows a full scale of 24 cm cor-
responding to the explanation depth of entire image and the displayed area (x 1.85),
approximately from 5.5 to 18.5 cm.

Angle Zoom Out Zoom Freq

2D Inv. Right

The magnifying factor depends on the image depth and the operating probe; according to
depth, 1 to 3 magnifying factors are available. The softpot is used to select the desired
magnifying factor: 1.15 to 3. The magnifying factor is displayed in the technical data area
on the right side of the screen. Press Zoom Out to exit.

3-28 SIGMA 110/SIGMA 330 10.12.01

 ‰ Freq ↑ / Freq ↓
This function allows the user to choose Freq + (higher frequency) for a standard patient or
Freq- (lower frequency) for a less echogenic patient. Pressing Freq ↓ decreases transmit-
ting frequency and displays Freq− in the technical data area. Pressing Freq ↑ increases
transmitting frequency and displays Freq+ in the technical data area on the right side of
the screen.
‰ Biopsy 1 /2/OFF
• Biopsy 1 displays the biopsy guide lines on the screen in single 2D format.
According to the operating probe, none, one or two guide lines are available. A biopsy
kit including two needle guide inclinations can be fitted on the 6.5 MR multiplane tran-
srectal probe; for this probe:
• Biopsy 2
displays the second biopsy guide lines corresponding to the second inclination of needle
guide.
• Biopsy OFF
is used to clear the screen of the lines.
‰ 2D Inv.
This function reverses the up/down orientation of the 2D-image displayed on the screen.
‰ Left/Right
This function changes the left/right orientation of the 2D-image.
The KONTRON MEDICAL Logo, at the top right/left of the 2D-image sector, indicates the
image orientation.
‰ Tilt
This function is used to tilt 2D angle. It is useful with the transvaginal probe (6.5 EV only)
for ovarian exploration. MP softpot shifts the image sector. A graphic symbol shows the
shooting angle direction.
‰ AddFocus
For Linear/Convex probes it is possible to set up to four focus areas. Select "AddFocus" to
add a focal point. Use the trackball to move it. When 4 focus zones are selected, pressing
the "AddFocus" key sets the image back to 1 focus zone.
‰ Trigger
This function enables ECG trigger(s) when ECG Option is installed. See Chapter 3.16,
“ECG (Option)”, on page 3-95.
‰ Gamma
Eight compression curves (1 to 8) are selectable by using MP softpot. The first six ones
vary gradually from dark and soft image (Number 1) to light and contrasted image (Number
6); the numbers 7 and 8 are inverted. Default Gamma setting is probe dependent.
‰ Smooth
Four different (0 to 3) settings of image filtering are selectable to improve image smooth-
ness and reduce noise level. Smooth 0: without "Smooth" filtering.
‰ Enhance
This function offers the possibility to improve the image sharpening, enhancement of ves-
sel wall and organ contour. Enhancement increases from number -3 to +3.
‰ Reject
This function controls the dynamic range of the ultrasound echoes and allows a better dif-
ferentiation of tissues.

10.12.01 OPERATING INSTRUCTIONS 3-29

 • Reject 0: maximum dynamic range, soft image.
• Reject 3: maximum rejection, more contrasted image.
‰ Rainbow (SIGMA 330 only)
This function controls the colorisation of the ultrasound image. The MP softpot allows the
selection of 8 sets of colour (Rainb 0 to Rainb 7). The one selected is shown in the Techni-
cal Data Window. Rainb 0 corresponds to black and white image display. Rainb 1 to 7 cor-
respond to colorised image.
‰ TI/MI
This feature displays/hides the Thermal or Mechanical Indexes.

3.7.1.3 2D Frozen Menu

This menu is displayed by pressing the FREEZE button:

Gamma Store

Rainbow Cine Archive

‰ Store (if KIPRISM is available)

To store the actual frozen image in memory, this button has to be pressed.
‰ Archive (if KIPRISM is available)
Enters the KIPRISM archive, if a minimum of one image is stored on the formatted Flash
Card.
‰ Cine
Displays the menu dedicated to cine replay management.
For details of Store/Archive function see Chapter 3.11, “Digital Archiving: KIPRISM”, on page
3-51.

3.7.1.4 2D Gain

‰ Overall gain is controlled by rotating the uppermost knob on the right side of the keyboard.
32 positions are available.
‰ TGC is controlled by sliding the five rectilinear potentiometers on the top-right of the key-
board. These five compensation gain controls are independently acting on the correspond-
ing exploration areas. Normal setting is all five TGC potentiometers centered.

3-30 SIGMA 110/SIGMA 330 10.12.01

3.7.2 TM (Time Motion)
Press TM key to select TM mode (see figure 1-4, “Keyboard”, on page 1-13 to locate the key).
The TM marker is positioned over the 2D image. The echoes corresponding to the selected
beam are displayed on a scrolling trace.

1. The first time that you press TM key, you enter double image 2D+TM display. The TM
line marker is superimposed on 2D live Image. The 2D/TM Menu is displayed on the
screen. Use the trackball to move the line over the 2D image, so as to place it on the
area which has to be studied.
2. Set the TM line to the desired position. When releasing the trackball the 2D image is
automatically frozen and the Time Motion becomes active. If the TM line is repositioned
using the trackball the 2D image will get unfrozen again. The 2D image can be refreshed
at the end of each TM sweep.The "Refresh" option can be enabled or disabled in the
"Preferences" Menu (SET UP > Prefs > Display > Refr ON/OFF).
3. If the user want to get the 2D image active without changing again to TM, press the
SELECT key. To restart the automatic changing between 2D and TM press the SELECT
key again.
4. Press a second time the TM key to display a TM single format.

10.12.01 OPERATING INSTRUCTIONS 3-31

3.7.2.1 TM Mode Selection

or

Figure 3-4: TM Mode Selection

3-32 SIGMA 110/SIGMA 330 10.12.01

3.7.2.2 TM Live Menu

This menu is displayed when TM mode is selected.

Sweep Freq
page 1
TM Inv.

Gamma Enhance Reject

page 2
Rainbow TI

‰ Sweep
This function allows the user to select different time bases, approximately from 1 to 4 sec-
onds in 2D + TM and 2 to 8 sec. in full screen TM. Turning the softpot clockwise increases
scrolling speed and consequently decreases time base.
‰ Freq ↑ / Freq ↓
This function allows the user to choose Freq ↑ for a standard patient or Freq ↓ for a less
echogenic patient.
‰ TM Inv.
This function reverses the up/down orientation of the 2D-image displayed on the screen.
‰ Gamma
8 compression GAMMA curves are selectable by using the MP potentiometer.
‰ Enhance
increasing contour enhancement to improve the image sharpening.
7 positions are available between -3 and 3.
‰ Reject
This function controls the dynamic range of the echoes that are displayed on the screen.
‰ Rainbow (SIGMA 330 only)
This function controls the colorisation of ultrasound image. The MP softpot allows the
selection of 8 sets of colour (Rainbow 0 to Rainbow 7). The one selected is shown in the
Technical Data Window.
Rainbow 0 corresponds to black and white image display.
Rainbow 1 to 7 corresponds to colorised image.
‰ TI/MI
Display/Hide Thermal or Mechanical Indexes.

3.7.2.3 TM frozen Menu

See 2D frozen menu in Chapter 3.7.1.3, “2D Frozen Menu”, on page 3-30.

3.7.2.4 TM Gain

Overall gain is controlled by rotating the uppermost knob on the right side of the keyboard. 32
positions are available.
Slope is controlled by using 5 rectilinear potentiometers on the top-right of the keyboard.

10.12.01 OPERATING INSTRUCTIONS 3-33

3.7.3 PW Doppler
SIGMA 110 and SIGMA 330 can perform Pulse Wave Doppler (PW) if Doppler option is installed.
Press PW key to select PW mode

1. The first time that you press the PW key, you enter PW mode, 2D+PW is displayed. The
marker and the gate are displayed on the 2D image. The trackball allows the user to
move the marker on the image and to slide the gate on the marker, to reach the
required area.
If CFM option is installed (SIGMA 330), in CFM/PW mode the PW gate never exits the
CFM window (region of interest). So, moving the PW gate moves also the CFM window.
2. Set the PW line to the desired position. When releasing the trackball the 2D image is
automatically frozen and the PW mode becomes active. If the PW line is repositioned
using the trackball the 2D image will get unfrozen again. The 2D image is refreshed at
the end of each PW sweep.The "Refresh" option can be enabled or disabled in the
"Preferences" Menu (SET UP > Prefs > Display > Refr ON/OFF).
3. If the user want to get the 2D image active without changing again to PW, press the
SELECT key. To restart the automatically changing between 2D and PW press the
SELECT key again.
4. Press a second time the PW key to display a 2D icon/PW format.

3-34 SIGMA 110/SIGMA 330 10.12.01

3.7.3.1 PW Mode Selection

or

Figure 3-5: PW Mode Selection

10.12.01 OPERATING INSTRUCTIONS 3-35

3.7.3.2 PW Live Menu

If PW is active the following SP menu is displayed on the screen (2D+PW display).

Sweep Gatesize Baseline VelRange PRFx2

page 1
Sp. Inv. Freq D Angle Energy Steer\

Gamma Max WallFilt

page 2
Rainbow TI

‰ Sweep
This function allows the user to select different sweep speeds, approximately from 1 to 4
seconds in 2D + SP and 2 to 8 sec. in full screen SP. Turning MP potentiometer clockwise
increases scrolling speed and consequently decreases time base.
‰ Gatesize
This function adjusts gate size. The user can select a sample volume size of: 1, 2, 4, 6, 8,
10, 12 and 15 mm.
‰ Baseline
The soft-pot shifts the spectrum baseline. 9 positions are selectable: -100, -75, -50, -25, 0,
+25, +50, +75, +100%.
‰ VelRange
This function changes the Velocity Range. Velocity range depends on Doppler frequency. It
can be displayed in kHz or m/s. When selecting m/s, it is displayed in cm/s for velocities
lower than 1 m/s and in m/s for velocities greater than 1m/s.
‰ PRF/PRFx2/PRFx3
This function changes the Pulse Repetition Frequency. PRFx2 and PRFx3 are extended
ranges where PRF is multiplied by 2 and 3 respectively.
‰ WallFilt
This function is used to select the wall filter cut-off frequency. The selected frequency value
is displayed on the screen in the technical data area on the right side of the screen. The fol-
lowing wall filter frequencies are available: 50, 75, 100, 150, 200, 300, 400, 500, 750, 1000
Hz.
‰ Sp. Inv.
This function reverses the up/down orientation of the spectrum displayed on the screen.
‰ Freq
This function is used to select the different Doppler frequencies: 2, 3, 4, 8 MHz Doppler fre-
quencies are available and can be selected by using MP potentiometer. An optimized Dop-
pler frequency is automatically selected according to the operating probe. However, the
operator can select another frequency (except for pencil probes).
Note :
The available Doppler frequencies are dependent of the selected probe. For instance, Pencil
Probes are used at only one frequency.

3-36 SIGMA 110/SIGMA 330 10.12.01

 ‰ D Angle
This function is used to adjust angle correction. Use the MP potentiometer to rotate the
flow direction cursor on the line marker. The angle is adjustable from -70 to 70 degrees.
The velocity scale is automatically changed according to the angle.
‰ Energy
This parameter depends on operating probe and its dedicated applications. It is stored in
the Factory Setup. When selecting Energy, the associated MP potentiometer allows the
user to reduce the transmit energy: 0, -3, -6, -9, -12, -15, -18, -21 dB attenuation. 0 dB cor-
responds to maximum energy which is smaller or equal to the recommended level for the
selected application (see Chapter 1.7.12, “Acoustic Power”, on page 1-51).
‰ Steer
This function is available when Linear Probe is selected. It allows the user to choose the
steering angle of the Doppler beam: no steering, left steering, right steering. The steering
angle depends on the selected probe and the emitted frequency.
‰ Gamma
When selecting Gamma, the associated MP potentiometer selects different compression
curves which perform a compression of spectrum gray levels on the screen.
‰ Max / Mean / Max+Mean
SIGMA 110 and SIGMA 330 can calculate mean and max velocities and display the corre-
sponding curves on Doppler spectrum.This button functions in a circular manner:
• Off: no trace display
• Max: display of Vmax+ and Vmax- curves in orange on Doppler spectrum.
• Mean: display of Vmean curve in blue on Doppler spectrum.
• Max + Mean: display of Vmax+ and Vmax- curves in orange and Vmean curve in blue
simultaneously on Doppler spectrum.
Note :
The automatic integral or PI/RI calculations are based on Vmax trace. They can be selected
even though Vmax trace is not displayed. MVI is based on Vmean trace.
‰ Rainbow (SIGMA 330 only)
This function controls the colorisation of spectrum image. The MP softpot allows the selec-
tion of 8 sets of colour (Rainbow 0 to Rainb 7). The selected one is shown in the technical
data area on the right side of the screen.
Rainbow 0 corresponds to black and white image display.
Rainbow 1 to 7 corresponds to colorised spectrum.
‰ TI/MI
Display/Hide Thermal or Mechanical Indexes.

3.7.3.3 PW Frozen Menu

Gamma Max Store

Rainbow D Angle Archive

10.12.01 OPERATING INSTRUCTIONS 3-37

See section PW live menu above for details of items.
See 2D frozen menu in Chapter 3.7.1.3, “2D Frozen Menu”, on page 3-30.

3.7.3.4 PW Doppler Audio Amplifier

SIGMA 330 and SIGMA 110 include a stereo amplifier with associated loudspeakers to amplify
Doppler audio signal. Volume is adjustable by rotating the uppermost knob on the left side on the
front of the monitor housing.

3-38 SIGMA 110/SIGMA 330 10.12.01

3.7.4 CW Doppler
SIGMA 110 and SIGMA 330 perform Continuous Wave Doppler (CW) when Doppler option is
installed.
Not all of the transducers are CW compatible. See table -i, “Probe applications,” on page -xvi for
the CW compatible probes.

1. The first time that you press the CW key, you enter CW mode, 2D+CW is displayed.
The CW line marker is displayed on the 2D image. The trackball allows the user to move
the marker on the image to reach the required area.
2. Set the CW line to the desired position. When releasing the trackball the 2D image is
automatically frozen and the CW mode becomes active. If the CW line is repositioned by
the trackball the 2D image will get unfrozen again. The 2D image is refreshed at the end
of each CW sweep.The "Refresh" function can be enabled or disabled in the "Prefer-
ences" Menu (SET UP > Prefs > Display > Refr ON/OFF).
3. If the user want to get the 2D image active without changing again to CW, press the
SELECT key. To restart the automatically changing between 2D and CW press the
SELECT key again.
4. Press a second time the CW key to display a 2D icon/CW format.

10.12.01 OPERATING INSTRUCTIONS 3-39

3.7.4.1 CW Mode Selection

or

Figure 3-6: CW Mode Selection

3-40 SIGMA 110/SIGMA 330 10.12.01

3.7.4.2 CW Live Menu

If CW mode is active the following SP menu is displayed on the screen. The 2D image is frozen
or refreshed at the end of each SP sweep.

Sweep Baseline VelRange

page 1
Sp. Inv. Freq D Angle Energy

Gamma Max WallFilt

page 2
Rainbow TI

The CW menu is similar to the PW menu except:

‰ Gate Size which is not significant in CW Doppler can not be selected.

‰ Steering function is not available.

See section PW live menu in Chapter 3.7.3.2, “PW Live Menu”, on page 3-36 for details of the dif-
ferent items.

3.7.4.3 CW frozen menu

Gamma Max Store

Rainbow D Angle Archive

See section PW frozen menu in Chapter 3.7.3.3, “PW Frozen Menu”, on page 3-37 for details of
items.
See 2D frozen menu in Chapter 3.7.1.3, “2D Frozen Menu”, on page 3-30.

3.7.4.4 CW Doppler Audio Amplifier

SIGMA 330 and SIGMA 110 include a stereo amplifier with associated loudspeakers to amplify
Doppler audio signal. Volume is adjustable by rotating the uppermost knob on the left side on the
front of the monitor housing.

10.12.01 OPERATING INSTRUCTIONS 3-41

3.7.5 CFM Mode
SIGMA 330 can perform Colour Flow Mapping (CFM) when CFM option is installed and CFM
compatible probe is used.
See table -i, “Probe applications,” on page -xvi for the CFM compatible probes.
Press CFM key to select CFM mode (see figure 1-4, “Keyboard”, on page 1-13 to locate the key).

3.7.5.1 CFM Mode Selection

Figure 3-7: CFM Mode Selection

3.7.5.2 Sub-Application Menu

When selecting the CFM mode by pressing the CFM key, the sub-application menu is displayed
first. The user can select between the different sub-applications for his actual examination. By
selecting an appropriate sub-application the optimum parameter set for the application is loaded.

Liver & Periph. Fetal Periph.

Vein Kidney Artery Heart Vein

The displayed sub-application menu is dependent on the linear probe which is selected.
The sub-application menu does not exist for Cardio application and the CFM live menu is dis-
played when pressing the CFM key.

3-42 SIGMA 110/SIGMA 330 10.12.01

3.7.5.3 CFM live menu

From the previous menu, Sub-Application, press ESC to display the CFM live menu:

SubAppl. Zoom Baseline

page 1
PwrMode Col.Inv. Col. Off VelRange Steer \

Col Map Turb On Resolu. Freq WallFil

page 2
Persist Energy TI

‰ SubAppl.
This button displays the sub-application menu described in Chapter 3.7.5.2, “Sub-Applica-
tion Menu”, on page 3-42, to change between the different sub-applications.
‰ Fast/Normal
In Cardiology, Fast/Normal replaces the SubAppl button. This function modifies the frame
rate. Select Normal for a higher sensitivity and Fast for a higher Frame rate.
‰ Baseline
Pressing this button selects the CFM baseline shift which can be changed with the MP. The
actual baseline position is displayed at the left side of the colour scale (see Chapter
1.5.1.2, “Colour/Grey Scale”, on page 1-34). The baseline position can be changed in 25%
steps between -100% and 100%.
‰ Pwr/VelMode
The user can select with the Power/Vel. key between power or velocity mode.
‰ Zoom
By pressing this button you can enter the Zoom mode.
‰ Col. Off
This button is used to hide the colour flow data. The mode is changed from CFM to 2D. All
of the CFM menu keys are no longer selectable.
The 2D menu is displayed including the Col. On key to switch back to CFM mode ("Tilt"
and "Ad Focus" items are not available when colour is off. See Chapter 3.7.1.2, “2D Live
Menu”, on page 3-28 for details).

Angle Zoom Freq Biopsy1

page 1
2D Inv. Right Col. On AddFocus Trigg 1

Gamma Smooth Enhance Reject

page 2
Rainbow TI

10.12.01 OPERATING INSTRUCTIONS 3-43

 ‰ VelRange
Pressing this button selects the velocity range which can be changed with the MP accord-
ing to the Doppler frequency.
‰ Steer
With this button the user can switch between three steering angles, left straight and right.
The angle depends on the selected probe and the selected CFM transmit frequency.
‰ Col Map
Pressing this button selects the colour map which can be changed with the MP. 8 different
colour maps are available.
‰ Turb On/Off
Display or hide the turbulence colour information.
‰ Resolu.
This key activates the changing of the colour flow resolution with the MP. Three different
resolutions are available: Low, Medium and High.
‰ Freq
This key activates the changing of the Doppler frequency according to the selected probe
with the MP.
‰ WallFilt
This key activates the changing of the wall filter cut-off frequency which can be manipu-
lated with the MP. The selectable cut-offs depend on the actual velocity range.
‰ Col Invert
Pressing this button toggles between inverted and non inverted colour map.
‰ Persist
Pressing this button activates the changing of the persistence of the colour pixels on
screen.
Three different persistence modes are available with the MP: 0 (no persistence), 1 and 2.
‰ Energy
Pressing this button activates the increasing/decreasing of the transmit energy. The energy
can be adjusted between -21dB and 0 dB in steps of 3dB with the MP. 0 dB corresponds to
maximum energy which is smaller or equal to the recommended level for the selected
application (see Chapter 1.7.12, “Acoustic Power”, on page 1-51).
‰ TI/MI
Display/Hide Thermal or Mechanical Index.

3.7.5.4 CFM Frozen Menu

When pressing the FREEZE button in CFM live mode, the following menu is displayed on
screen:

Col Map Thresh Baseline Store

Col.Inv. Col. Off Cine Archive

‰ Thresh
Pressing this key activates the setting of the threshold level between CFM and 2D informa-
tion in order to select whether the CFM or the 2D information is displayed. For low thresh-

3-44 SIGMA 110/SIGMA 330 10.12.01

 old the 2D information gets higher priority over the CFM information. The Threshold level
can be set by the MP.
See CFM live menu in Chapter , “From the previous menu, Sub-Application, press ESC to display
the CFM live menu:”, on page 3-43 for function details of the other buttons.
For Store and Archive function see Chapter 3.11, “Digital Archiving: KIPRISM”, on page 3-51.
The following menu is displayed if colour is off:

Gamma Store

Rainbow Col. On Cine Archive

See CFM live menu in Chapter , “From the previous menu, Sub-Application, press ESC to display
the CFM live menu:”, on page 3-43 for function details of the buttons.

3.7.5.5 CFM Window

‰ Overview
The colour flow mapping is related to the CFM Window. The CFM Window is the region of
interest where the user wants to display colour information. The wider the CFM window is,
the slower the frame rate - with an unchanged velocity range- is. Sizing and moving the
CFM window is a simple mean for the user to define the first and the last CFM beam.
‰ Moving and sizing CFM window
CFM window size and position are changed using the trackball. By pressing on one of the
upper two trackball keys, the user toggle the trackball assignment between these two oper-
ations. The distinction is made by drawing a sign inside the displaced corner when the
CFM window is sized.
‰ Position limitation
The position of the CFM window is limited in the angular and radial direction (x and y direc-
tion for flat probes):
• the CFM window cannot start at depth 0.
• the selected PRF limits the scanned CFM depth. When the user wants to exceed this
limit, the PRF is automatically modified.
‰ PRF Auto Adjustment
As above mentioned, the CFM window position and size is limited by the PRF. When the
user wants to exceed this limit, an auto adjustment will be performed: the PRF is set to the
next available lower value. The original value is restored as soon as the CFM window is
moved to a suitable position.

3.7.5.6 Trackball Assignment

In CFM mode, the trackball is assigned to different actions:

• in live mode
• resizing of the CFM window
• positioning of the CFM window
• moving Cursor pointer

10.12.01 OPERATING INSTRUCTIONS 3-45

 • moving zoomed window in zoomed CFM
• moving TM line in CFM/TM
• moving PW gate in CFM/PW
• in freeze mode:
• moving Cine loop
• moving Cursor pointer
• moving magnified area

3.7.6 3D imaging
This function uses the internal compact PC, see Chapter 3.20, “Integrated PC (SIGMA 330
Excellence)”, on page 3-110.
‰ 3D-FetalView
TM : for using this software module, please consult its proper user manual.

‰ 3D-VascularView
TM : for using this software module, please consult its proper user man-
ual.

3-46 SIGMA 110/SIGMA 330 10.12.01

3.8 Print
This function controls the Video Printer. The user can select between 2 print keys:
‰ Press PRINT 1 function key to print a "screen copy" on the B & W Video Printer

‰ Press PRINT 2 function key to print a "screen copy" on the Colour Printer or to store the
image in the digital archive (equivalent to the Store menu key in FREEZE mode).
See Chapter 3.6.5.4, “System”, on page 3-19 for PRINT2 configuration setting.
See Chapter 2.9.2, “Recommended Peripherals”, on page 2-17 for recommended Video Printer.

10.12.01 OPERATING INSTRUCTIONS 3-47

3.9 Cine Mode
The Cine mode is a specific function used to analyse a biological movement. This function allows
the user to store, in real time, up to 282 images in the SIGMA 110/330 Memory (with Cine Mode
Option installed for SIGMA 110). The tables summarize the number of images or trace screens
stored depending on format, medical application and probe.

FORMAT 2D IMAGES TRACE SCREENS

Annular Sector AS probes
Linear probes/
probes Radio, Vasc, TM Doppler
Convex probes
Cardio Ob/Gyn
min. - max min. - max min. - max
2D 44 - 282 66 - 130 45 - 92 NA NA
2D+TM
37 - 230 56 - 109 38 - 77 5 5
2Di+Doppler
2Di+Doppler 30 - 194 45 - 89 31 - 63 5 5
TM Doppler NA NA NA 16 16

Table 3-9: Cine Mode Memory in 2D

5.0 LV/ 3.5 MC/

FORMAT 7.5 LV 6.5 VMC 6.5 MC
7.5 LVS 3.5 CV
CFM 52 64 64 52-64 63-64
CFM / TM 44 64 64 44-64 53-64
CFMi / SP 35 60 60-64 35-64 43-64

Table 3-1 0: Cine Mode Memory in CFM

In CFM mode, the number of images stored depends mainly on the angle of the 2D sector; the
number of trace screens stored is the same as in 2D.
These images can be displayed and analysed image by image on the SIGMA 110/330 screen.
This function is always activated for all modes and formats, so the user can easily use it by
pressing the FREEZE key and using the trackball to select the images. In dual image formats
such as 2D/TM, 2D/PW use the SELECT key to switch between the two cine modes.

3.9.1 Storing Pictures

The system is continuously recording ultrasound images in memory. Press FREEZE key to stop
the recording.
The last images are stored in the SIGMA 110/330 memory. The latest is displayed on the video
screen. The displayed image number is shown at the bottom right of the video screen.

Note
By pressing the FREEZE key again, the previous stored images are overwritten. A new recording
is started.

3-48 SIGMA 110/SIGMA 330 10.12.01

3.9.2 Displaying Pictures
The user can analyse the images previously recorded. The trackball is used to perform either for-
ward or backward review. The displayed image number is shown at the bottom right of the video
screen.

3.9.3 Cine Auto-Replay

For each 2D and CFM frozen menu, Cine key is displayed. Pressing the Cine key displays the
Cine Menu that allows the user to easily manage the cine replay.

fps Store

Reset Archive

‰ / : play (in the defined limits using the selected frame rate) / stop the current cine
sequence. Note that when the cine is played, the cine frame counter is hidden.
The corresponding menu key is a two states key, the default action is “play”. Note that the
icon representing the next action is always displayed. So, when the cine is played, the stop
icon is displayed and vice versa.
‰ : play the cine step by step (in the defined limits using the selected step):
‰ select the start and the end images of the cine replay:

Start image End image

To select the start and the end images of the cine loop sequence, the user selects them
using the trackball (the cine loop is in manual mode) and validates his choice by selecting
the suitable key.
‰ reset the start and end image selection using the Reset key. The complete cine loop
sequence can then be played.
‰ define the number of frames per second (fps) displayed during the cine replay using the
fps key. This key is an incremental key and the frame rate replay is changed using the
incremental pot. The frame rate of the cine replay is always lower or equal to the acquisi-
tion frame rate and has to be chosen among the following values: 1, 2, 4, 6, 8, 12, 16, 25
fps.
The default value is 12 fps when this value is possible else 1 fps is selected.
‰ store the selected image on a SRAM flashcard using the Store key.
‰ review the images stored on a SRAM using the Archive key.

10.12.01 OPERATING INSTRUCTIONS 3-49

3.1 0 Magnifier in 2D and CFM Mode
Press MAGNIFY key to magnify the image displayed on the screen.
Use the trackball to move and select the portion of the image to be displayed.
In 2D/CFM mode use the upper left select key of the trackball to switch between moving magni-
fied image and moving CFM window if magnifying is active.
Press MAGNIFY key once more or 2D to return to the normal format.
The graphic symbol below shows that the image is magnified:

The magnification function works equally well on live images and frozen ones.
NOTE
Magnify can use a zoom factor up to 6 dependent on the different probes.

3-50 SIGMA 110/SIGMA 330 10.12.01

3.1 1 Digital Archiving: KIPRISM
The SIGMA 110 and SIGMA 330 systems include the KIPRISM features which allows the user to
store ultrasound images, report and patient information on Memory Cards (SRAM flash cards).
The KIPRISM logo is displayed on the bottom left of the SIGMA Start-up
screen.
KIPRISM allows displaying and storing images in thumbnail format as well as
full screen format on a memory card. The memory card can be read by any PC
equipped with a recommended PCMCIA driver, refer to Chapter 2.9.3, “Archiv-
ing on Personal Computer”, on page 2-17.
All selections can be done with the trackball and the three associated SET keys.
KIPRISM features:
‰ report printout.

‰ user interface for images: multi patient environment, multi images (Thumbnails presenta-
tion) with calibration information, image storage and restore from memory cards.
‰ user interface for report: store report and patient information. Display report preview and
report sheets from the memory card.
‰ DICOM compatibility.

‰ used for EasyPrint: printing images with connected inkjet printer.

3.1 1 .1 Image Storage and Freeze Menu

STORE and ARCHIVE functions are available from every freeze menu in all modes.
Press FREEZE key to display the following menu:

xxxx xxxx xxxx xxxx Store

xxxx xxxx xxxx xxxx Archive

‰ The STORE key stores the current image, displayed on the SIGMA screen, in the memory
card. This key is automatically disabled if there is no space left on the memory card or if the
memory card does not use the KIPRISM format.
‰ The ARCHIVE key enters the archive mode. This key is automatically disabled if no data
are stored in the memory card, if the memory card does not use the KIPRISM format or no
card is inserted.
‰ The PRINT 2 key of the user interface can be configured to store images on memory cards.
In the setups, the user can select the action of this key: print on a colour video printer or
save on the memory card. If the KIPRISM option is enabled, the default action is set to the
image storage on memory card.
If the PRINT 2 key is associated to the memory card:
• The user can save images when the machine is in LIVE mode.
• A beep will be generated if there is no space left on the memory card, if the memory
card does not use the KIPRISM format or no card is inserted.
If the memory card format is not valid, a dialogue box offers the possibility to format it. For format-
ting a memory card, refer to Chapter 3.6.6, “PCMCIA CARD”, on page 3-23.

10.12.01 OPERATING INSTRUCTIONS 3-51

To store an image on a memory card:

1.Insert the memory card in the dedicated slot on the right side of system. Put the card in
the slide guide, respecting the connection direction (label side up), and push it gently up
to the connector stop.
2. Press FREEZE key
3. Press Store key
If the PRINT 2 key is associated with storing pictures on memory cards, you can directly press
the PRINT 2 key to freeze the screen and store the picture on memory card.

3.1 1 .2 Archive: Display of Stored Images

3.11.2.1 Panels of 16 Images

Pressing Archive displays the archive menu and a screen layout divided in 16 locations dedi-
cated to insert the images stored on the memory card.
The image selected by
default is the last one 02/04/01 10:53:35
stored. The border of the
selected image is high-
lighted (in yellow for SIGMA
330).
For selecting an image use
the trackball.
Each image can be named
by the user.
The title of the selected
image is automatically dis-
played between the menu
and the bottom of the
panel. SIMPSON: Left Ventricle„
Delete Del.All
Undo
A set of 16 images can be Image Imag-
displayed; this consists of
an images panel. When
more than 16 images are stored, more than one panel exists.
Press one of the upper SET key of the trackball to invoke the full screen display mode; the
selected image is displayed.

3.11.2.2 Menus

The labels of the menu are automatically updated when the user changes the trackball assign-
ment, but the actions associated do not change:
‰ The first key selects the previous panel of items (patients or the thumbnails). This key
is disabled for the titles or if only one panel exists for the thumbnails.
‰ The second key selects the next panel of items (patients or thumbnails). This key is
disabled for the titles or if only one panel exists for the thumbnails.

3-52 SIGMA 110/SIGMA 330 10.12.01

 ‰ The third key is used to delete the current selected item (patients, titles or thumbnails).
When the user presses it, a dialogue box appears for a confirmation (not for the title).
‰ The fourth key is used to delete all items of the selection (patients, titles or thumbnails).
When the user presses it a dialogue box appears for a confirmation.
‰ The fifth key is used to undo the deletion of items. It restores all deleted items, it is not an
“undo action”. This key is not available for the titles. This key is disabled if no items have
been deleted.
This menu is available when the selection is assigned to the thumbnails:

Delete Del.All
Undo
Image Images

This menu is available when the selection is assigned to the Titles.

Delete Del.All
Undo
Title Titles

3.11.2.3 Principles of Selection and Validation

‰ The three SET keys change the assignment of the trackball. The trackball can be
assigned to the image list, or to the title (to change the position of the character cursor), or
to the list of patients.

1 2

4 3

‰ The UPPER SET keys 1 2 :

• If the trackball is assigned to the thumbnails, it opens the selected images in full screen
mode.
• If the trackball is not assigned to the thumbnails, it assigns the trackball to the thumb-
nails and validates the current selection i.e. the patient selected or the title selected.
‰ The BOTTOM SET key 3 :
• If the trackball is assigned to the title, it validates the new title, and assigns the trackball
to the thumbnails. (like the UPPER SET key).
• If the trackball is not assigned to the title, it assigns the trackball to the title.
‰ The TRACKBALL 4 : To choose an image, a patient or character in the title.
‰ The ENTER key: Can be used to validate the title, instead of the UPPER SET key or the
BOTTOM SET key.

10.12.01 OPERATING INSTRUCTIONS 3-53

3.11.2.4 Full Screen Display

In this mode the image selected is displayed in its normal size.

The image stored is inde-
pendent from the video for- SMITH 02/04/01 10:53:35
mat (PAL or NTSC), but it
depends on the original
screen colours (B/W or Col- Technical
our). data
The title of the image is dis-
played at the bottom of the
image, above the menu
and can be modified as
explained before.
‰ The Keys 1 to 6
select the corre-
sponding image
index. Left Ventricle„
‰ The key selects 1 2 3 Delete
the next image found 4 5 6 Icons
in the list. The menu
is automatically
updated. If only one image is stored, this key is disabled.
‰ The key selects the previous image found in the list. The menu is automatically updated.
If only one image is stored, this key is disabled.
‰ The Delete key deletes the image. A dialogue box appears for a confirmation. If the user
chooses Ok, the image is deleted and the program returns automatically to the thumbnails
mode. After this action, the UNDO key is enabled.
‰ The Icons key returns to the image panel mode.

3.11.2.5 Exit Archive mode

‰ The keys allowing to quit this mode are: ESCAPE, FREEZE and PROBE.
‰ The POWER_OFF key is always enabled.
‰ When the user exits this mode all deleted items are definitely erased and lost.

3.1 1 .3 Using the Memory Card on PC

The memory card can be used on a standard Personal Computer equipped with a PCMCIA card
reader. See Chapter 2.9.3, “Archiving on Personal Computer”, on page 2-17 for recommended
PCMCIA card adapter.
With KIPRISM, image files (.PCX) and report files (.TXT) can be saved on a SRAM via the
SIGMA PCMCIA drive. These files can be read directly on a PC via its PCMCIA drive using an
image editor for image files and a text editor for reports.
File name consists of 8 characters for the actual name, plus 3 characters for the file name exten-
sion.
The name (8 characters) is split into two parts:

3-54 SIGMA 110/SIGMA 330 10.12.01

 ‰ the six first characters are based on the patient name or the image title as shown below:
Patient name Image Title File name of image files File name of report files
Not defined Not defined Default namea Default namea
Defined Not defined Patient nameb Patient nameb
Not defined or
Defined Titlec
Defined

a. IMAGE or REPORT.
b. 6 first characters of the patient name (completed if necessary by “_” characters).
c. 6 first characters of the title (completed if necessary by “_” characters).
‰ the two last characters are reserved for the number of the image or report (e.g. “01”, “02”,
“03”... “99”).

3.1 1 .4 Patient Report and Patient ID with KIPRISM

The icon is used to store the current state of the report. For details on the different icons
see Appendix B, “Report Menu”, on page 7-5.

3.11.4.1 Ob/Gyn Medical Application Report Menu

This menu is available on the Report when the medical application Ob/Gyn is chosen:

Report

The STORE key doesn’t save the current medical application or the current page displayed, but
saves all valid measurement in all medical applications.

3.11.4.2 Vasc., Cardio and Radio Medical Application Report Menus

This menu is available on the Report when the medical applications Vasc., Cardio or Radio are
chosen:

Report

The STORE key does not save the current medical application, but save all valid measurement in
all medical applications.

10.12.01 OPERATING INSTRUCTIONS 3-55

3.11.4.3 Report Print Preview menu

This menu is available on the Report in Print Preview mode:

3.11.4.4 Patient and Study Information

This menu is available when the user enters Patient ID:

ID

The STORE key will create a new patient file on the memory card if the user has pressed the new
patient key, else it will modify the last patient saved. Each time the STORE key is pressed, a dia-
logue box appears for a confirmation. To avoid confusion, a unique identifier is created internally
for each patient.

3.11.4.5 Reports

As above mentioned (Chap-

ter 3.11.2.1, “Panels of 16 27/04/00 10:53:35
FILE: SMITH.TXT
Images”, on page 3-52), the CREATED: 19/11/97 10:01:54
SIZE: 8.38KB
REPORT01.TXT
mode entered when press- PAGES: 13
REPORT03.TXT
ing on the “Archive” key of PATIENT INFORMATION SMITH.TXT
WESSON.TXT
the Freeze menu is the Laboratory........: SAINTE-ANNE
“Thumbnails” mode and the Physician.........:
Operator..........: MH
corresponding menu is dis-
PATIENT REFERENCES
played. To select the “Report
Patient name......: SMITH
Archive” mode, press on Address...........:
MENU NEXT; the screen is Phone number......:

changed as shown below: a

popup menu is displayed on
the right showing all reports
present on the flashcard and
the key information stored in
Delete Del.All Undo
the selected report text file is Report Reports
displayed on screen.

3-56 SIGMA 110/SIGMA 330 10.12.01

 ‰ The third menu key is used to delete a report. When the user presses it a dialogue box for
confirmation is then displayed and the report text file is deleted if the user selects “Yes”.
Do you really want to delete SMITH.TXT file?

Yes No

‰ The fourth key is used to delete all reports stored on the flashcard. When user presses it a
confirmation dialogue is displayed (“Do you really want to delete all reports? Yes/No”).
‰ The fifth key is used to Undo the deletion of reports. It restores all deleted reports. This key
is disabled if no items have been deleted.
Remark: the Undo action is impossible after Archive mode exit.

3.11.4.6 Patient

As above mentioned (Chap-

27/04/00 10:53:35
ter 3.11.2.1, “Panels of 16 PATIENT INFORMATION

Images”, on page 3-52), the Laboratory........: SAINTE-ANNE

CLARK
mode entered when press- Physician.........:
Operator..........: MH Undefined
ing on the “Archive” key of PATIENT REFERENCES
SMITH
WESSON
the Freeze menu is the LEVIS
Patient name......: SMITH Undefined
“Thumbnails” mode and the Address...........:
corresponding menu is dis- Phone number......:

played. To select the FILES: 5

“Patient Archive” mode, SMITH05.PCX 19/11/97 10:02:06

SMITH06.PCX 19/11/97 10:02:54
press on MENU PREVI- STENOS07.PCX 19/11/97 10:04:41
OUS; the screen is changed SMITH08.PCX 19/11/97 10:05:35
SMITH03.TXT 19/11/97 10:01:12
as shown below: a popup
list containing all the
patients present on the
flashcard is displayed on the Delete Del.All
right and the information for Patient Patients
the selected patient is dis-
played on the left.
‰ The third menu key is used to delete a Patient (ALL information relative to a patient). When
the user presses it, a dialogue box for confirmation is then displayed.

Do you really want to delete all data for patient SMITH?

Deletion cannot be undone

Yes No

‰ The 4th menu key is used to delete all data for all patients stored on the flashcard. When
the user presses it a dialogue box appears for a confirmation “Do you really want to delete
all data for all patients? Deletion cannot be undone. Yes/No”. With “Yes” the SRAM is for-
matted.

10.12.01 OPERATING INSTRUCTIONS 3-57

3.11.4.7 Battery State

When the user plugs a SRAM with a low state battery, a warning message is displayed to inform
the user.
If this message appears, the user should change the battery. The operation is described by the
SRAM manufacturer. After, this operation, the user must verify the format of its SRAM on the PC
and on the SIGMA. If the SRAM is no more formatted, the user must format it again on the
SIGMA.

3-58 SIGMA 110/SIGMA 330 10.12.01

3.1 2 Annotations
The ANNOTATE key displays the ANNOTATION Menu. This menu is used to write annotation,
labels or arrows on the screen.

Text Arrows Medical

page 1
Clear Clear ClearAll

User1 User2 Def. List Medical

page 2
User3 User4 Del. List Clear ClearAll

Note: Menu items links to F1, F2, F6 and F7 keys contains the reference to lists defined by the
user. In this document, these 4 lists are called User1, User2, User3 and User4. These four fields
are empty, when they contains no reference to a list (e.g. first use of the sigma).

3.1 2.1 Entering Annotation Mode

Annotate Freeze
Annotation Menu

Annotate

According to the last selected page of this menu, the first or the second page is displayed.

3.1 2.2 Exiting the Annotation Mode

Freeze Annotate

LIVE

Freeze

10.12.01 OPERATING INSTRUCTIONS 3-59

3.1 2.3 Manual Text Annotation
When the user enters the annotation menu, the manual text entry mode is selected by default (if
the page, which contains this menu item, is displayed). To activate it (after an arrow annotation
for instance) press on the Text key. To write text on screen, the user puts the calliper (trackball
cursor) at desired position and enters text by using alphanumeric keys
The number of text annotations is limited to 20.

Text

Annotation
Q W E R T
A S D F G
Z X C V B

To delete a part of annotation, place the cursor on the area to be deleted using the trackball and
press Backspace key (Õ Õ).
This is an annotation

Text

This is an annotation Backspace This is an annotation

To delete the entire text select Clear (Text).

To validate the text press ENTER (line feed is performed) or move the trackball for a new location
or press Text (or ANNOTATE to exit)

3.1 2.4 Labels

From the main ANNOTATION Menu, the user can enter predefined text (Labels).

3.12.4.1 Create a Label List

The user can create up to 4 labels lists for each Medical Application; each label list can include
up to 100 labels, but the entire number of labels is limited to 100.

3-60 SIGMA 110/SIGMA 330 10.12.01

 1. Press Annotate key and MENU NEXT to display the LABEL Menu.

Left
Right
Lobe
Isthmus
Thyroid
Longitudinal

Thyroid

User1 User2 Def. List Medical

User3 User4 Del. List Clear ClearAll

2. Press Def.Lst (Define List) key.

User1 User2 Def. List Medical

User3 User4 Del. List Clear ClearAll

3. Pressing New list, displays a dialogue box "List name"

New list

4. Enter the list name: ... [ex: Cardio 1, (max. 8 char.)], then press ENTER.
Creating a new list

Enter the list name:

The new list name appears in the list menu and a window is displayed on the top right of
the screen.
5. Enter the labels in the window using the keyboard (14 char. max/label), then press
ENTER.
6. Press Def.Lst to end the new list

10.12.01 OPERATING INSTRUCTIONS 3-61

3.12.4.2 Delete a Label List

1. Press Del.List

User1 User2 Def. List Medical

User3 User4 Del. List Clear ClearAll

2. Select the list to be deleted

User list User list

1 2

3. Confirm in the dialogue box: Yes or No

Deleting the list xxx

Do you want to continue?

Yes No

3.12.4.3 Renaming a User Label List

1. To rename a user label list, the user should press on the F3 key (Def. list) in the Anno-
tation menu.

New list User list User list

1 2

2. To rename one of the list, the user presses on the corresponding function key and
enters the new name.
Renaming the list xxx

Enter the new name:

On the label menu, the current name is automatically updated.

Remark: The number of user label list is limited to 4 for each medical application.

3.12.4.4 Label List

The size of the labels should be less than (or equal to) 14 characters. At the same time, only 6
labels can be displayed in the list box. If the label list is greater than 6 labels, only the first 6 ones
are displayed. Arrows (scrolling Up/Down Arrow) are displayed on the top and on the bottom to
scroll the list (page scrolling).

3-62 SIGMA 110/SIGMA 330 10.12.01

 ‰ Adding and deleting user labels
To add user labels in the current label list, the user selects the empty field at the end of the
list (by pressing on the upper left trackball key or any alphanumeric key) enters its new
label and validates this label by pressing on the <ENTER> key.
To delete a label, select it and press on the <BACKSPACE> key, the complete label will be
removed.
‰ Moving the label list Up/Down
By moving the trackball the user puts the focus rectangle on the scrolling Up or Down
arrow. When the focus rectangle is on the scrolling Up (Down) Arrow, the list scrolls up
(down) automatically by step of one page until the beginning (end) of the list is reached).
scrolling Up Arrow
Left
Right
Lobe
Isthmus
Thyroid Focus rectangle
Longitudinal

scrolling Down Arrow

3.12.4.5 Changing Current Displayed List

By using the function keys (F1, F2, F6, F7), another label list is selected. On the right part of the
screen the current displayed label list is replaced by the new one.

3.12.4.6 Displaying a Label on the Ultrasound Image

The user selects a label by moving the trackball up or down and validates it by pressing on the
upper left trackball key. A rectangle is displayed on the ultrasound image, the user moves it to the
desired place. By pressing on the upper left trackball key, the user fixes the label at the current
position.
Left Left
Right Right
Lobe Lobe
Isthmus Isthmus
Thyroid Thyroid

SET
Longitudinal Longitudinal

SET
Longitudinal

3.12.4.7 Erasing Labels

‰ Clear label
By pressing on the Clear key, the user will erase the last displayed label.
‰ Clear all labels
By pressing on the Clear all key, the user will erase all the displayed annotation (labels,
texts, arrows and body marker).
Remark: Labels are identical to text annotation, so in the preference menu you can choose
between keeping text and labels when unfreezing or not. See Chapter 3.6.5.2, “Display”, on page
3-15, issue Annotation for details.

10.12.01 OPERATING INSTRUCTIONS 3-63

3.1 2.5 Arrows
Selecting Arrows in the ANNOTATION Menu displays an arrow on the left side of the screen.
Use the trackball to move the arrow anywhere on the screen and the softpot to change its orien-
tation (8 positions are available). It is possible to display up to 20 arrows anywhere on the screen.

Arrows

To delete an arrow select Clear (Arrow).

3-64 SIGMA 110/SIGMA 330 10.12.01

3.1 3 Body Markers
A set of body markers is available for each medical application. The body markers are used to
annotate the ultrasound image. They show the examined part of the body.
The orientation marker shows the scan plane. For Cardiology, there is no orientation marker; the
body marker shows the plane itself.
The body markers are accessible from the main ANNOTATION Menu and FREEZE Menu.

3.1 3.1 Displaying Body markers

To display the body markers:

1. Press the Body Marker key to display the Body Marker Menu.

ChgBdyM ScanDir Move Medical

Clear ClearAll

2. Select the desired BODY MARKER in the

scrolling list, using the trackball then press scrolling Up Arrow
Upper SET key. The Body Marker is displayed
in the bottom right corner of the selected Focus rectangle
image.
To scroll the body marker list, the user puts the
focus rectangle on the scrolling Up or Down
arrow. When the focus rectangle is on the
scrolling Up (Down) Arrow, the list is automati-
cally scrolling up (down) in order to select other scrolling Down Arrow
available body markers.

3. Use the Trackball to move the scan direction marker and/or

Use MP potentiometer to modify the orientation of the scan plane
marker (except in cardiology application) then press Upper SET
key.
The angle of the marker can vary from -75° to +75°, by step of 15°.

4. Press ESCape to exit the BODY MARKER Menu.

10.12.01 OPERATING INSTRUCTIONS 3-65

3.1 3.2 Moving Body Markers
In Dual, Quad and Archive mode, the Body Markers can be moved anywhere on the selected
image.
To move the body markers:

1. Press the Move key.

2. Select the desired image using the SELECT key. 3
3. Move the marker using the Trackball.
4. Then press Upper SET key.

4
3.1 3.3 Deleting Body markers
To delete the body markers:
Selecting Clear (Body Mrk) erases the last Body Marker.
Selecting ClearAll clears the screen of all Body Markers and all annotations.
Different body markers are available in the different medical applications (see Chapter 3.13.4,
“Medical”, on page 3-66 and Appendix L, “Body Markers”, on page 7-111)

3.1 3.4 Medical

Selecting Medical in the ANNOTATION Menu displays the Medical Application menu:
The user can select one of the Medical Applications: Ob/Gyn, Radio, Vasc. and Cardio. The cor-
responding set of Body Markers will be available. The Medical Application menu can be
accessed from Study sheet by selecting "Medical Application" icon.
Note that the setting parameters of the operating probe are not affected by this change.

Medical Ob/Gyn Radio Vasc. Cardio

F1, F2, F3,F4

Selects a medical application

3.1 3.5 Deleting All Annotations

Select ClearAll to clear the screen of all annotations.

3-66 SIGMA 110/SIGMA 330 10.12.01

3.1 4 Measurements
Measurement can be made on any image. Callipers are available from 2D-Mode, TM-Mode,
Doppler spectrum and CFM to measure distances, areas, angles, times, slopes, velocities, etc.
The results are automatically displayed on the screen. Up to ten results of the most recent meas-
urements can be displayed on the right side of the screen.

3.1 4.1 Generalities

3.14.1.1 Entering the Measurement Mode

To enter the measurement mode press the MEASURE key.

The MEASURE Menu is displayed on the screen and ultrasound image is frozen.

3.14.1.2 Quitting the Measurement Mode

Press FREEZE key to quit the MEASUREMENT mode and return to live image of the current
imaging mode.
Press MEASURE key to quit the MEASUREMENT mode and return to frozen image of the cur-
rent imaging mode.

3.14.1.3 Validation Keys

Generally the trackball is used to move something on the screen. The trackball is joined with two
validation keys (upper trackball keys); one or the other have the same function. These keys are
named SET in the following description.
The trackball and attached keys are used to perform measurements.

3.14.1.4 Other Useful Keys

‰ Undo Soft Key

With the Undo key the user can delete one by one the different measurements he has
made (last in, first out).
‰ Escape Key
The ESCape key (ESC) can be used to abort the current measurement. When using this
key the system returns to the measurement menu.
‰ Backspace Key
The Backspace key (Õ Õ) in the alphanumeric keypad can be used to erase the last point,
for example, when tracing an area contour.

3.14.1.5 Result Display

Measurement results are displayed on the right side of the screen, just under the technical data.
Ten result lines could be displayed at the same time. The results are displayed from the top to the
bottom. Each displayed result contains: the order number of the result, the type, the value and
the unit.

10.12.01 OPERATING INSTRUCTIONS 3-67

3.14.1.6 Including Measurement in Biometry Study

When a measurement has been made in the measurement mode, the result can be integrated in
the biometry study. For this, press REPORT key, the current biometry page is displayed; then
select the desired field by moving the cursor with the trackball and valid with SET key.

Note
The report must be entered from measurement mode to allow inclusion.

3.14.1.7 Formulas of the Displayed Measurements

For details about the formulas which stand behind the displayed measurement see Chapter 7,
“APPENDICES”, on page 7-1.

3.1 4.2 Starting a Measurement

1. Press MEASUREMENT key to enter Measurement Mode. The measurement menu is

displayed on the screen and the ultrasound image is frozen.
2. Use the function keys to select the desired measurement.
3. Use the trackball to move the cursor to the desired position.
4. Press SET key (upper left trackball key). The value is automatically displayed on the
screen (example: velocity) or the second cursor appears for the measurement which
needs several cursors (example: distance, area, etc....).
5. Press SET key (upper left trackball key) to perform one more measurement of same
type or press a menu key to make another measurement.
6. Select Undo in the measurement menu to erase the most recent measure.
7. Press FREEZE key or MEASUREMENT key to quit Measurement Mode.

3.1 4.3 2D Measurement

If you press on MEASUREMENT key, SIGMA 110/330 displays the following menu:
‰ in 2D-mode

Distance Area Ellipse Angle

Ratio Undo

‰ In dual 2D and Quad 2D

Distance Area Ellipse Angle Volume

Ratio Undo

3-68 SIGMA 110/SIGMA 330 10.12.01

 ‰ in [2D]/SP :

Distance Area Ellipse Angle BloodFl.

Ratio Undo

Note
Distance is automatically selected when entering Measurement mode.

3.14.3.1 Measuring a Distance

Technical Data

7
6#K 7535 v v
7#K 6535 v v

Distance Area Ellipse Angle

Ratio Undo

1. Press F1 (Distance) to select distance measurement (Distance is automatically

selected when entering Measurement mode).
2. Use the trackball to move the first marker to the desired position.
3. Press upper left SET key to fix the marker; the second end marker is now available.
4. Use the trackball to move the second marker to the desired position. A doted line
appears to show the position of the distance measurement.
5. Press upper left SET key. The result is automatically displayed on the screen. The
doted line stays if the preference "doted line" has been selected in the set up preference
menu. The doted line disappears if the preference "no doted line" has been selected in
the set up preference menu.
During the measurement, the user can delete a part of the current measurement by pressing on
the BACKSPACE (Õ Õ) key.
Distance results are always in millimetres.

10.12.01 OPERATING INSTRUCTIONS 3-69

3.14.3.2 Measuring an Area

Technical Data

6
6#H 5377 l v 7
6#J 63=8 l v

Distance Area Ellipse Angle

Ratio Undo

1. Press F2 (Area) to select area measurement.

2. Use the trackball to move the first marker to the desired position.
3. Press upper left SET key to fix the marker; the second marker is now available.
4. Use the trackball to move the marker and draw the area.
5. there are two ways of finishing the measurement:
• Press upper left SET key. The result is automatically displayed on the screen.
• Return on the start point of the area measurement, when the two markers are super-
posed the area measurement is ended.

During the measurement, the user can delete a part of the current curve by pressing on the
BACKSPACE (Õ Õ) key.
For this measurement, two results are displayed: the area in square centimetres and the circum-
ference (perimeter) in centimetres.

3.14.3.3 Measuring an Ellipse

Technical Data

6#H 5377 l v 7
6#J 63=8 l v
6

Distance Area Ellipse Angle

Ratio Undo
6

1. Press F3 (Ellipse) to select ellipse measurement.

2. Use the trackball to move the first marker to the desired position.
3. Press upper left SET key to fix the first marker; the second marker is now available.

3-70 SIGMA 110/SIGMA 330 10.12.01

 4. Use the trackball to move the marker and define the length of the first axis.
5. Press upper left SET key to fix the first ellipse axis; an ellipse is now displayed.
6. Use the trackball to modify the ellipse shape; superpose the ellipse and the element to
be measured.
7. Press upper left SET key to finish the measurement. The result is immediately dis-
played on the screen.
For this measurement, two results are displayed: the area in square centimetres and the circum-
ference in centimetres.

3.14.3.4 Measuring an Angle

Technical Data

6
6#Hwp 9@3@

Distance Area Ellipse Angle

Ratio Undo

1. Press F4 (Angle) to select angle measurement.

2. Use the trackball to move the first marker (angle vertex) to the desired position.
3. Press upper left SET key to fix the marker; the second end marker of the first angle side
is now available.
4. Use the trackball to move the second marker to the desired position.
5. Press upper left SET key to fix the first angle side; the second end marker of the sec-
ond angle side is now available.
6. Use the trackball to move this marker to the desired position.
7. Press upper left SET key to fix the second angle side. The result is automatically dis-
played on the screen.
Angle is always displayed in degrees.

10.12.01 OPERATING INSTRUCTIONS 3-71

3.14.3.5 Volume

The volume measurement is composed of three distance measurements: height and width dis-
tance measurements on the first 2D pad and depth distance measurement on the second one, or
vice versa.
6
6
6#J 3
6 6#K6 3vv
6#K7 3vv
6#K8 3vv
6#] 3lv8

Ellipse Thyroid
Undo
0.523 0.479

The coefficient used for the volume computation is also displayed in the measurement result
Measurement results
C xxx.x C : Coefficient
D1 xxx.x mm D1: Distance
D2 xxx.x mm D2: Distance
D3 xxx.x mm D3: Distance
V xxx.x cm3 V : Volume

pad.
When the “Volume” key is pressed, the following sub-menu is displayed:

Ellipse: Thyroid:
Undo
0.523 0.479
.

A maximum of four volume measurements are available. The labels displayed in the measure-
ment key give information about:
• the kind of volume the measurement apply to,
• the coefficient used in the computation. The volumes are computed according to the fol-
lowing formula:
V D α ⋅ ( D1 ⋅ D2 ⋅ D3 )

α : coefficient
D1 : Distance 1 in millimetres
D2 : Distance 2 in millimetres
D3 : Distance 3 in millimetres
V : Volume in cm3

The labels and coefficients are defined by the user in the Radiology Study Sheet (see Chapter H,
ÚRadiology StudyÛ , on page 7-85). If the relevant data are not defined in the Radiology Study
Sheet, the default measurements are the following:
• ellipsoid volume using a coefficient of 0.523:
4⁄3⋅π
V D ------------- ⋅ ( D1 ⋅ D2 ⋅ D3 )
8
α : coefficient = 0.523
D1 : Distance 1 in millimetres
D2 : Distance 2 in millimetres

3-72 SIGMA 110/SIGMA 330 10.12.01

 D3 : Distance 3 in millimetres
V : Volume in cm3
• thyroid volume using a coefficient of 0.479:
V D 0,479 ⋅ ( D1 ⋅ D2 ⋅ D3 )

α : coefficient = 0.479
D1 : Distance 1 in millimetres
D2 : Distance 2 in millimetres
D3 : Distance 3 in millimetres
V : Volume in cm3

3.14.3.6 Ratio

The ratio computation is a special measurement related to the last measurement: e.g. if the user
has made a distance measurement, by using the Ratio key, the user will make a second distance
measurement and the ratio between the first distance measurement and the second one will be
automatically computed.
The 2D ratio calculation is available for the:
• Distance measurement
• Area measurement
Ratio on 2D distance measurement

Technical Data

7
6#K 7535 v v
7#K 6535 v v
7#Yj } #<535 )

Distance Area Ellipse Angle

Ratio Undo

For the ratio on a 2D distance measurement, the result of the distance measurement and of the
distance ratio measurement is displayed.

Ratio on 2D area measurement

Technical Data

7 6#H 6>3><l v 7
6#J 6@3><l v
7#H #9395 l v 7
7#J <375 l v
7#Yj } 793>@)

Distance Area Ellipse Angle

Ratio Undo

10.12.01 OPERATING INSTRUCTIONS 3-73

For the ratio on a 2D area measurement, the values of the area result and of the area ratio meas-
urement is displayed.

3.14.3.7 Specific 2D Ob/Gyn Measurement

The specific Ob/Gyn (CRL, GES, ...) measurement can be classified in two groups:
‰ the specific measurements which use the distance measurement (CRL, FML, ...)

‰ the specific measurements which use area or ellipse measurement (AC, HC).

All these specific measurements work like a distance or an area/ellipse measurement. So the
distance (or area/ellipse) results and the EFA (Estimated Foetal Age) results computed from the
current measurement are displayed.
1 BPD 2.00 mm Distance measurement
1 EFA 3+2 wk
2 A 17.7 cm2 Area/Ellipse measurement
2 AC 19.7 cm
2 EFA 6+3 wk
Remarks:
‰ the EFA is computed according to the current Ob/Gyn tables (selection made through the
Ob/Gyn report).
‰ the report is automatically updated, according to the current measurement.

‰ If the user changes its working Ob/Gyn tables, the measurement pad will be automatically
erased, to keep coherence between displayed data and Ob/Gyn setup. (report automati-
cally updated).
‰ For more information refer to Appendix F, “Ob/Gyn Studies”, on page 7-37.

2D Ob/Gyn measurement menu (NWA <= 1 5 weeks)

Distance CRL ChD GES FML

page 1
TAD AC HC BPD Undo

Distance Area Ellipse Angle Volume

page 2
Ratio Undo

3-74 SIGMA 110/SIGMA 330 10.12.01

2D Ob/Gyn generic measurement menu (NWA > 1 5 weeks or unknown LMP)

Distance BPD HC AC TAD

page 1
APD FML THD HuL Undo

Distance Area Ellipse Angle Volume

page 2
Ratio Undo

3.1 4.4 CFM Measurement

This is only available if CFM mode is installed on the SIGMA system. Refer to table 1-3, “System
configuration and options,” on page 1-6 for SIGMA systems with CFM.
CFM measurement menuA

Distance Area Ellipse Angle

Velocity Freq. Vel. Prof Ratio Undo

The CFM measurement menu contains all the 2D measurements and some specific CFM meas-
urements:
‰ CFM velocity mode:

• the velocity and the frequency measurement: both are measured at the calliper posi-
tion
• the velocity profile measurement: the velocity is measured and displayed along a line.
‰ CFM power mode:

• velocity and frequency measurement: not available.

• power profile measurement: the power is measured and displayed along a line.
The blood flow measurement is available only in [CFM]/SP mode.
When entering in the CFM measurement menu, the distance measurement is set by default.

3.14.4.1 Distance

See 2D Measurement, Chapter 3.14.3.1, “Measuring a Distance”, on page 3-69

3.14.4.2 Area

See 2D Measurement, Chapter 3.14.3.2, “Measuring an Area”, on page 3-70

3.14.4.3 Ellipse

See 2D Measurement, Chapter 3.14.3.3, “Measuring an Ellipse”, on page 3-70

10.12.01 OPERATING INSTRUCTIONS 3-75

3.14.4.4 Angle

See 2D Measurement, Chapter 3.14.3.4, “Measuring an Angle”, on page 3-71

3.14.4.5 Velocity

Technical Data

6
6#] 7835 l v 4|

Distance Area Ellipse Angle

Velocity Freq. Vel. Prof. Ratio Undo

The CFM velocity measurement is made by setting one point on the image. The CFM velocity at
this point is computed according to the current image format (velocity range), and is displayed in
cm/s or m/s on the right side of the screen.

3.14.4.6 Frequency

Technical Data

6 6#M 7385 t O

Distance Area Ellipse Angle

Velocity Freq Vel. Prof. Ratio Undo

The CFM frequency measurement is made by setting one point on the image. The CFM fre-
quency at this point is computed according to the current image format (velocity range), and is
displayed in kilo Hertz on the right side of the screen.

3-76 SIGMA 110/SIGMA 330 10.12.01

3.14.4.7 Velocity/Power Profile

Technical Data

Legend
Positive Velocity
Negative Velocity
6

Distance Area Ellipse Angle

Velocity Freq. Vel. Prof. Ratio Undo

The CFM Velocity Profile measurement is made by setting two points on the image. When the
second point is set, a graphical display of the CFM velocity or power from each point of this line
will be made. No results are displayed on the right side of the screen.

3.14.4.8 Ratio

See 2D Measurement, Chapter 3.14.3.6, “Ratio”, on page 3-73

3.1 4.5 TM Measurement

If you press on MEASURE key in TM-mode, SIGMA 110/330 displays the following menu:

Distance Time Slope Heart

Rate

Ab.LVSt Fu.LVSt Ratio / Undo

Delta%

• Distance: default selection

¿ Time
¿ SLOPE
• HeartRate: Heart Rate
• Ab_LVSt: Abbreviated Left Ventricle Study
• Fu_LVSt: Full Left Ventricle Study
• Ratio/Delta%: Delta = 1-d1/d2 for distance; Ratio = A/B for other meas.
¿ Undo

10.12.01 OPERATING INSTRUCTIONS 3-77

3.14.5.1 Distance

Technical Data

6#K 75355 v v

Distance Time Slope Heart

Rate

Ab.LVSt Fu.LVSt Delta% Undo

The TM distance measurement is made by setting two points on the image. The two cursors
used for this measurement can only be moved in the vertical way. The distance between these
points is computed according to the current image format (depth), and is displayed in millimetres
on the right side of the screen.

3.14.5.2 Time

Technical Data

6 6

6#[ 6355 |

Distance Time Slope Heart

Rate

Ab.LVSt Fu.LVSt Ratio Undo

The TM Time measurement is made by setting two lines on the image (start and end line). The
time between these two lines is computed according to the current scrolling speed, and is dis-
played in seconds on the right side of the screen.

3-78 SIGMA 110/SIGMA 330 10.12.01

3.14.5.3 Slope

Technical Data

6
6#Z 7355 l v 4|
6#[ 7355 |
6#K 9535 v v

Distance Time Slope Heart

Rate

Ab.LVSt Fu.LVSt Ratio Undo

The TM Slope measurement is made by setting two points on the image. The slope between
these two points is computed according to the current image format (depth for the distance and
scrolling speed for the time), and is displayed in cm/s on the right side of the screen.

3.14.5.4 Heart Rate

Technical Data
6 6

6#M =5 k4v w
6#[ 6355 |

Distance Time Slope Heart

Rate

Ab.LVSt Fu.LVSt Ratio Undo

The TM Heart Rate measurement is made by setting two lines on the image (start and end line).
The heart rate and the time between these two lines is computed according to the current scroll-
ing speed, and is displayed in seconds for the time and in beats per minute for the heart rate on
the right side of the screen.

10.12.01 OPERATING INSTRUCTIONS 3-79

3.14.5.5 Left Ventricular Study

The Left Ventricle Study can be computed as a full measurement or as an abbreviated measure-
ment.
So two different entries are implemented in the TM measurement menu:
‰ Fu.LVSt: Full Left Ventricle Study:

6
6
PZm PZ|
6PZm 735<l v
6SKm 83@@l v
6W^ m 63>5 l v
SKm 6PZ| 63>5 l v
SK|
6SK| 838>l v
6W^ | 6387 l v
6PZ 6>35>)
W
^ m W
^ | 6SK 6<3<9 )
6W^ 7738<)
6LM{ 8837>)

Distance Time Slope Heart

Rate

Ab.LVSt Fu.LVSt Ratio Undo

• ISd: Inter Ventricular Septal Thickness (diastole) in cm

• LDd: Left Ventricle Diameter (diastole) in cm
• PWd: Posterior Left Ventricular Wall (diastole) in cm
• ISs: Inter Ventricular Septal Thickness (systole) in cm
• LDs: Left Ventricle Diameter (systole) in cm
• PWs: Posterior Left Ventricular Wall (systole) in cm
• IS: Inter Ventricular Septal Thickness ratio
• LD:Left Ventricle Diameter ratio
• PW: Posterior Left Ventricular Wall ratio
• EFr:Ejection Fraction

3-80 SIGMA 110/SIGMA 330 10.12.01

 ‰ Ab.LVSt: Abbreviate Left Ventricle Study

PZm
6PZm 735<l v
6 6SKm 83@@l v
6W^ m 63>5 l v
SKm 6SK| 838>l v
SK|
6SK 6<3<9 )
6LM{ 8837>)

W^ m

Distance Time Slope Heart

Rate

Ab.LVSt Fu.LVSt Ratio Undo

3.14.5.6 TM Ratio or Delta Ratio

The TM ratio (or delta ratio) calculation is available for the:

• TM Distance measurement (delta ratio)
• TM Time measurement (ratio)
Delta ratio on TM distance measurement

Technical Data

6 7

6#K 75355 v v
7#K 65355 v v
7#∆D #65535 )

Distance Time Slope Heart

Rate

Ab.LVSt Fu.LVSt Delta% Undo

For the delta ratio on a TM distance measurement, the result of the distance measurement and
of the distance delta ratio measurement is displayed.

10.12.01 OPERATING INSTRUCTIONS 3-81

Ratio on TM time measurement

Technical Data

6 7 7 6

6#[ 6355 |
7#[ #537<|
7Yj } 7<355 )

Distance Time Slope Heart

Rate

Ab.LVSt Fu.LVSt Ratio Undo

For the ratio on a TM time measurement, the result of the time measurement in seconds and of
the time ratio measurement in percent is displayed.

3.1 4.6 Doppler Measurement

If you press on MEASURE key in SP-mode, SIGMA 110/330 displays the following menu,
depending on Medical Application:
‰ Cardio application:

SpeedGr. Freq. VTI Time HeartRt

page 1
PI&RI Mitral PHT Ratio Undo

Acceler. MVI
page 2
BloodFl. RI Undo

‰ Ob/Gyn application:

SpeedGr. Freq. VTI Time HeartRt

page 1
PI&RI RI PHT Ratio Undo

Acceler. MVI
page 2
BloodFl. Mitral Undo

‰ other applications:

3-82 SIGMA 110/SIGMA 330 10.12.01

 SpeedGr. Freq. VTI Time HeartRt
page 1
BloodFl. RI PHT Ratio Undo

Acceler. MVI
page 2
PI&RI Mitral Undo

Note that the Doppler vector angle must be carefully adjusted before the blood flow meas-
urement is started. A message is displayed just above the menu, when the measurement
is entered:
"Please check the position of the Doppler vector angle before the measure starts"

3.14.6.1 Speed/Gradient Measurement

For the Speed/Gradient measurement (and the frequency measurement), the start point is linked
to the baseline and it can only be moved horizontally. When the user turns the trackball in the
vertical direction, he moves the second point, which gives the velocity (this point can be moved in
the positive and the negative areas).

1. Press F1 (SpeedGr.) to select speed gradient measurement.

2. Use the trackball to move the marker to the desired position.
3. Press upper left SET key to fix the marker. The result is automatically displayed on the
screen. The doted line stays if the preference "doted line" has been selected in the set
up preference menu. The doted line disappears if the preference "no doted line" has
been selected in the set up preference menu.
During the measurement, the user can delete a part of the current measurement by pressing on
the BACKSPACE (Õ Õ) key.

- 1.0
- 0.8
- 0.6 6
- 0.4 +
- 0.2
-0 + 6#] nu 53<5#v 4|
- 0.2 6#W tN 6355#v v Op
- 0.4
- 0.6
- 0.8
- 1.0
m/s

SpeedGr. Freq. VTI Time HeartRt

PI&RI RI PHT Ratio Undo

The result of the Speed/Gradient measurement depends on the current SP scale and is dis-
played in centimetres per seconds (if the maximal scale velocity is in centimetres per seconds) or
in meters per second on the right side of the screen.

10.12.01 OPERATING INSTRUCTIONS 3-83

3.14.6.2 Frequency Measurement

The frequency measurement is made like the Speed/Gradient measurement, but the result is
displayed in kHz.

1.
Press F2 (Freq.) to select frequency measurement.
2.
Use the trackball to move the marker to the desired position.
3.
Press upper left SET key to fix the marker. The result is automatically displayed on the
screen. The doted line stays if the preference "doted line" has been selected in the set
up preference menu. The doted line disappears if the preference "no doted line" has
been selected in the set up preference menu.
During the measurement, the user can delete a part of the current measurement by pressing on
the BACKSPACE (Õ Õ) key.

- 1.0
- 0.8
- 0.6 6
- 0.4 +
- 0.2
-0 + 6#M 7385 t O
- 0.2
- 0.4
- 0.6
- 0.8
- 1.0
m/s

SpeedGr. Freq. VTI Time HeartRt

PI&RI RI PHT Ratio Undo

The result of the frequency measurement depends on the current SP scale and is displayed in
kHertz on the right side of the screen.

3.14.6.3 Velocity Time Integral and Mean Velocity Integral Measurement.

By adding VMean/VMax automatic detection feature, the integral measurement has been modi-
fied to be made automatically or manually on the two different integrals types:
‰ VMax integral

‰ VMean integral

On the ultrasound page these two integral measurement results are always called I for Integral,
but on the biometry pages, these two results are called differently to be easily distinguished.
If VTI or MVI measurement is selected by the user, a sub-menu is displayed to erase the last dis-
played points (equivalent to the Backspace key) or to be able to switch from automatic to manual
integral computation (for VTI only, MVI is always automatic).

3-84 SIGMA 110/SIGMA 330 10.12.01

Automatic VMax and VMean measurement

VTI TAMX MVI TAV

or MnV or MnV

+ +
- -

Biometry results for VMax Biometry results for VMean

VTI xx.xx cm MVI xx.xx cm
PkV xx.xx cm/s PkV xx.xx cm/s
TAM xx.xx cm/s TAV xx.xx cm/s
PkG xx.xx mmHg PkG xx.xx mmHg
MnG xx.xx mmHg MnG xx.xx mmHg

1. When the first integral point is set, the integral (VMax or VMean) will be drawn automat-
ically by moving the trackball to the right (follows the blue points in a VMean integral
measurement and the orange points in a VMax integral measurement).
2. To finish the integral measurement, the user will press on the Upper Left Set Key.
3. By pressing on the VTI/MVI key, the following menu will be displayed (when MVI is
pressed, the Auto/Manual button is disabled).

Auto./
Manual.

For VTI, the drawing mode defined in the preference menu is activated (default VMax
auto.). So in the preference menu, an entry permits to choose between the automatic or
manual VTI computation.
4. If the user agrees the default drawing mode, he starts his measurement by setting the
first integral point at the desired position by pressing the Upper Left Set Key If he wants
to use another drawing mode, he just presses on the Manual/Auto key.

Remarks:
‰ During automatic VTI computation, the user can switch to the manual mode by pressing on
the Manual/Auto key and return to the previous automatic mode by pressing on the same
key (auto/manual toggle key on F1 ).
‰ During automatic VTI/MVI computation, the user can erase a part of the current measure-
ment, by pressing on the Backspace key on the right of the alphanumeric keyboard or on
the F4 key (same function as backspace) or on the F5 key (equivalent to 5 backspace) or
move the trackball from the right to the left.
‰ Manual integral measurement (VTI only):
By choosing this mode (available only for VTI), the user can draw the integral himself.

10.12.01 OPERATING INSTRUCTIONS 3-85

3.14.6.4 Time

See TM Measurement, Chapter 3.14.5.2, “Time”, on page 3-78 for details.

3.14.6.5 Heart Rate

See TM Measurement, Chapter 3.14.5.4, “Heart Rate”, on page 3-79 for details.

3.14.6.6 Blood Flow

This measurement is only available in 2D/SP, 2Di/SP, CFM/SP or CFMi/SP modes.

6
6#K #v v #
6[ H] #l v 4|
6#I M #u4v w

Distance Area Ellipse Angle BloodFl.

Ratio Undo

Measurement results

D x.xx mm Diameter of the vessel

TAV xxx.x cm/s Time Average Velocity

BF x.xx l/mm Blood Flow

The blood flow is measured in two steps and a message displayed for each step just above the
menu:
• first doing a distance measurement on the 2D image.
The message "Distance measurement" is displayed.
• then doing a MVI measurement on the SP pad to get the TAV
The message "<SET>: select the first point of the MVI integral" is displayed. Once, the
first point is selected, the MVI sub-menu is displayed (see Chapter 3.14.6.3, ÚVelocity
Time Integral and Mean Velocity Integral Measurement.Û , on page 3-84).
The blood flow is computed by using the formula:

π 2
TAV ⋅ 60 ⋅ --- ⋅ D
4
BF D ------------------------------------------
-
1000

BF : Blood Flow in l/min.

TAV : Time Average Velocity in cm/s
D : Diameter of the vessel in cm

3-86 SIGMA 110/SIGMA 330 10.12.01

Note that the calliper moves are automatically limited to the right pad (2D pad for distance meas-
urement and PW pad for MVI measurement).

3.14.6.7 Pulsatility and Resistance Index Measurement

Like for the VTI/MVI measurement, the PI/RI measurement can be made in automatic or manual
mode, the same menu than the integral menu is displayed when pressing on the PI & RI key.
This measurement is similar to the VMax Integral (Chapter 3.14.6.3, “Velocity Time Integral and
Mean Velocity Integral Measurement.”, on page 3-84).
The PI and RI measurements are computed by drawing an integral on the Doppler spectrum and
by setting the Diastole point (the Systole point is automatically computed and is equal to the
Peak Velocity). All these results are displayed on the right side of the screen.

3.14.6.8 Resistance Index Measurement

The RI measurement is computed by setting two velocities on the Doppler spectrum and the
result is displayed on the right side of the screen.

1. Press F7 (RI) to select resistance index measurement.

2. Use the trackball to move the first velocity marker to the desired position.
3. Press upper left SET key to fix the marker; the first velocity is set, the second velocity
marker is now available.
4. Use the trackball to move the second marker to the desired position.
5. Press upper left SET key to fix the second velocity marker. The result is automatically
displayed on the screen.

- 1.0
- 0.8
- 0.6 6+
- 0.4
- 0.2 7
+
-0 + + 6#Z | 53=v 4|
- 0.2 6#Krj 539 v 4|
- 0.4 6#YP 5388
- 0.6
- 0.8
- 1.0
m/s

SpeedGr. Freq. VTI Time HeartRt

PI&RI RI PHT Ratio Undo

The Systolic velocity is displayed in cm/s or m/s.

The Diastolic velocity is displayed in cm/s or m/s.

3.14.6.9 Pressure Half Time Measurement

The Pressure Half Time is measured by setting two points (like for the acceleration measure-
ment) on the Doppler spectrum.

1. Press F8 (PHT) to select pressure half time measurement.

2. Use the trackball to move the first marker to the desired position.

10.12.01 OPERATING INSTRUCTIONS 3-87

 3. Press upper left SET key to fix the marker; the second end marker is now available.
4. Use the trackball to move the second marker to the desired position.
5. Press upper left SET key to fix the second marker. The result is automatically displayed
on the screen.

- 1.0
- 0.8
- 0.6 6
- 0.4 +
- 0.2
-0 + 6#W O[ 9>>3<v |
- 0.2 6#] nu 7<3=l v 4|
- 0.4
6#Hl l 536=v 4| 7
- 0.6
- 0.8
- 1.0
m/s

SpeedGr. Freq. VTI Time HeartRt

PI&RI RI PHT Ratio Undo

Pressure Half Time is displayed in ms.

Peak Velocity is displayed in m/s.
Acceleration is displayed in m/s2.

3.14.6.10Ratio Measurement

‰ On Speed measurement and on frequency measurement:

- 1.0
- 0.8 6
- 0.6 8
- 0.4 7
9
- 0.2
-0
6#] nu 53<5#v 4|
- 0.2
6#W tN 6355#v v Op
- 0.4 7#] nu 537<v 4|
- 0.6 7#W tN 537<#v v Op
- 0.8 7#Yj } <5355 )
- 1.0
m/s
8#M 7385 RO
SpeedGr. Freq. VTI Time HeartRt 9#M 6365 RO
9#Yj } 9>3@5 )

PI&RI RI PHT Ratio Undo

For the ratio on a Speed (or Frequency) measurement, the result of the speed (or fre-
quency) and of their ratio is displayed.
‰ On Doppler Time measurement:
Refer to Chapter 3.14.5.6, “TM Ratio or Delta Ratio”, on page 3-81

3.14.6.11 Acceleration Measurement

The Acceleration is measured by setting two points on the Doppler spectrum. The acceleration
between these points is computed according to the current image format (velocity and scrolling
speed), and is displayed in meter per square second on the right side of the screen.

3-88 SIGMA 110/SIGMA 330 10.12.01

 1. Press F1 on menu page 2 (Acceler.) to select acceleration measurement.
2. Use the trackball to move the first marker to the desired position.
3. Press upper left SET key to fix the marker; the second end marker is now available.
4. Use the trackball to move the second marker to the desired position.
5. Press upper left SET key to fix the second marker. The result is automatically displayed
on the screen.

- 1.0
- 0.8
- 0.6 6
- 0.4 +
- 0.2
-0 +
6H 738? v 4| 7
- 0.2
- 0.4
- 0.6
- 0.8
- 1.0
m/s

Acceler. Mitral MVI

Undo

Acceleration is displayed in m/s2.

3.14.6.12Mitral Valve Measurement

The Mitral Valve Area is measured by setting two points (like for the acceleration measurement)
on the Doppler spectrum.

1. Press F2 on menu page 2 (Mitral) to select mitral measurement.

2. Use the trackball to move the first marker to the desired position.
3. Press upper left SET key to fix the marker; the second end marker is now available.
4. Use the trackball to move the second marker to the desired position.
5. Press upper left SET key to fix the second marker. The result is automatically displayed
on the screen.

- 1.0
- 0.8
- 0.6 6
- 0.4 +
- 0.2
-0 +
6H 738? l v 7
- 0.2 6#WO[ @738 v |
- 0.4
- 0.6
- 0.8
- 1.0
m/s

Acceler. Mitral MVI

Undo

Mitral Valve Area is displayed in cm2.

Pressure Half Time is displayed in ms.

10.12.01 OPERATING INSTRUCTIONS 3-89

3.1 5 Biometry and Report
See also Chapter 7, “APPENDICES”, on page 7-1

3.1 5.1 Biometry Pictograms

The pictograms which appear on all biometry/report sheets are described in Appendix 7,
“APPENDICES”, on page 7-1

3.1 5.2 Patient Information

The patient identification screen contains the information concerning patient and laboratory. (See
Appendix C, “Patient Information”, on page 7-7)
For each new patient, the user must invoke this mode to clear all biometry measurement and
results.
Some data which appears on this screen can be modified in the report; data modified in the
report are automatically changed on this page.
The best way to start a new patient study is:

1. Press ID key to display the Patient information sheet.

2. Select New Patient to erase all patient information.
3. Enter information concerning the new patient with the alphanumeric keyboard.
To enter text:
• Move the cursor on the area to be filled in with the trackball; the selected zone is high-
lighted.
• Enter the characters.
• End with © (ENTER key).

3.1 5.3 Biometry Patient Study

The Biometry patient study is made of measurements and calculations according to medical
applications.
The different biometry pages have the following arrangement:
‰ At the top of the page, the patient and laboratory information is displayed, and can be mod-
ified directly. The patient identification page will be automatically updated according to this
modification. When some modifications are made from the Patient Identification page, the
information displayed on the biometry page is updated.
‰ The second part of this page contains the different biometry calculation (medical applica-
tion dependent).
‰ The third part contains the different tools icons. Remark: an inverted video icon means that
it is selected.
The cursor can be moved with the trackball. When the cursor is over a valid measurement field,
the selected field is displayed in inverted video. To select the current measurement, the user
press on the SET key or ENTER key.
By selecting the REPORT icon, the user displays the printable report of his measurement.
The TRASH icon is used to delete a result.
To delete a result:

3-90 SIGMA 110/SIGMA 330 10.12.01

 1. Select the field to be cleared (a selected field is displayed in inverted video).
2. Select the TRASH icon, the selected field will be reset to zero.

By pressing F1 (MEDICAL APPLICATION), the user can change the medical application.

The CURVE VIEW icon is used to display the different curves:

‰ from OB/GYN STUDY sheet: place the cursor on the measurement of interest; when the
field is highlighted press F3 (CURVE VIEW); the corresponding curve is displayed.
‰ from OB/GYN SETUP sheet: place the cursor on the name of the desired gestational table
and press F3 (CURVE VIEW); the corresponding curve is displayed.
The "Curve View" sheet displays the selected curve, the related measurement values and the
Number of Weeks of Amenorrhea (NWA). Note that a point is displayed on the curve; this point is
the measurement of interest when NWA is less than 15 weeks; else, the displayed point matches
with NWA.
See the different Biometry sheets in Chapter 7, “APPENDICES”, on page 7-1.

3.1 5.4 Report

This function produces a document with all the measurement values, calculation results and
patient data, reasonably arranged in patient report. All information is shown in an explicit form.
The report can be displayed on the screen by pressing REPORT icon in the Biometry Study
Menu.
The report can be printed on parallel printer by pressing PRINT icon in the Biometry Study Menu.

3.1 5.5 Starting a Study

To start a study on a new patient, the following operations are required:

1. Editing a patient identification sheet

2. Editing a biometry study sheet

3.15.5.1 Editing a Patient Identification Sheet

To edit a patient identification sheet:

1. Press ID key.
The complete patient identification data sheet appears on the screen.

Note
The New Patient icon deletes all data, except those related to Laboratory identification. This
function is recommended to restart a study at the beginning or to start a study on a new patient.

2. Type on alphanumeric keyboard to fill out the desired areas. Please refer to Chapter
3.12.3, “Manual Text Annotation”, on page 3-60.
3. Press REPORT key to display the biometry study sheet which corresponds to current
mode and medical application

10.12.01 OPERATING INSTRUCTIONS 3-91

 • or press ID key to return to a frozen image.
• or press FREEZE key to return to a live image.

3.15.5.2 Editing a Biometry Study Sheet

To edit a biometry sheet:

1. Acquiring the required ultrasound image

2. Press REPORT key. The specific biometry study sheet appears on the screen.
3. Click1 on the desired area corresponding to measurement to be performed.
• The ultrasound image appears on the screen
• Perform the required measurement. See Chapter 3.14, “Measurements”, on page 3-67.
• After completing the measurement the screen automatically toggles to the biometry
sheet.
• The value of the measurement is stored in the current field.
4. Repeat the operations in item 3 as many time as required.
5. Select REPORT pictogram to edit the corresponding report or select NEXT PAGE picto-
gram to display the next page of the Biometry study.

The user can exit the current Biometry Study using the following keys:
‰ REPORT to return to the frozen image
‰ FREEZE to return to the live image
‰ MAGNIFY to magnify the frozen image
‰ MEASURE to enter Measurement Menu (frozen image)
‰ ANNOTATE to enter Annotate Menu (frozen image)
‰ ESC to exit Biometry Study when first sheet is displayed (see also Chapter 1.4, “System
Controls”, on page 1-28).

Note
During some transfers, "Please wait..." message appears on the screen to show that the system
is changing display format.

3.1 5.6 Radiology Study

The abdominal and pediatrics study is included on the radiology study sheet. See Radiology
study sheet, measurements and equations in Appendix H, “Radiology Study”, on page 7-85.

1. Click = TRACKBALL/CURSOR + SET, move the cursor to the desired area (when the cursor is over a
selectable area, the corresponding field is highlighted) and press SET.

3-92 SIGMA 110/SIGMA 330 10.12.01

3.1 5.7 Obstetrics/Gynaecology Study
From Ob/Gyn Medical Application:

3.15.7.1 EBD according to LMP

1.Press REPORT key to display Ob/Gyn Study Sheet.

2.Highlight LMP area with trackball and enter the date of Last Menstrual Period with
alphanumeric keyboard as:
• Day/Month/Year for PAL version Example: 26/02/2001 (26 February 2001)
• Month/Day/Year for NTSC version Example: 02/26/2001 (February 26th, 2001)
When LMP date information is entered, the system calculates EBD (Estimated Birth Date) and
NWA (Number of Weeks of Amenorrhea).

3.15.7.2 Fetus Age according to Physical Measurement

1. Acquire an ultrasound image in 2D mode.

2. Press REPORT key to display Ob/Gyn Study Sheet.
3. Select (in the "Meas" column) the field corresponding to the parameter to be measured;
when it is highlighted ...
4. Press SET key; the system switches to the ultrasound image display.
5. Perform the required measurement; the according value and estimated foetus age
appear on screen; when the measurement is confirmed, the study sheet is displayed
again. The measured value is stored and displayed in the study sheet.
6. For each measurement, the system determines the Age of the fetus and EBD, using a
table. When all measurements are performed, the system calculates some parameters
and ratios such as AUA..., HC/AC...

3.15.7.3 Growth Curves

The CURVE VIEW icon is used to display the different growth curves:
‰ from OB/GYN STUDY sheet: place the cursor on the measurement of interest; when the
field is highlighted press F3 (CURVE VIEW); the corresponding curve is displayed.
‰ from OB/GYN SETUP sheet: place the cursor on the name of desired gestational table and
press F3 (CURVE VIEW); the corresponding curve is displayed.

10.12.01 OPERATING INSTRUCTIONS 3-93

 14/01/00 08:30:31

BPD from Hadlock

cm

50

45

40

35

30

25
Length(cm) : 26.8
20 Age : 7 wk 5 d
+/- : 2 d
15

10 NWA: 7.5 wk

0 week
0 2 4 6 8 10

The point displayed is obtained with the NWA (according to the LMP), and the value measured.
Its position, compared to the reference curve, gives an immediate indication of the fetus growth.
See OB/GYN study sheet, SETUP sheet, USER SETUP table, measurements and equations in
Appendix F, “Ob/Gyn Studies”, on page 7-37.

3.1 5.8 Vascular Study

The Vascular study sheet is displayed in Vasc. Medical Application.
A vascular study sheet is available in Radio Medical application when PW or CW mode is
selected.
See Vascular study sheet, measurements and equations in Appendix E, “Vascular Study”, on
page 7-31.

3.1 5.9 Cardiology Study

The Cardiology study includes four study sheets:
‰ Left Ventricle Study

‰ Mitral Valve Study

‰ Aortic Valve Study

‰ Right Ventricle Study

See Cardiology study sheets, measurements and equations in Appendix D, “Cardiology Study”,
on page 7-11.

3-94 SIGMA 110/SIGMA 330 10.12.01

3.1 6 ECG (Option)
The optional ECG Module can be coupled to SIGMA 110 and SIGMA 330 systems via COM1
input located on the rear connector panel.
The ECG Module includes an ECG signal amplifier for displaying the trace on the video screen
and a QRS detector for synchronizing the 2D image.
ECG is activated for Cardio Setups (enabling is probe setup dependent). It is disabled by default
for other applications.
To enable ECG:

1. Press SETUP key on the keyboard

2. Press Prefs in the Setup Menu
3. Press Display in the Preferences Menu
4. Press ECG ON in the Display Menu
Heart Rate (HR, in b/min.) is automatically calculated by the system (average on 5 QRS periods)
when the QRS waveform appears on the screen, and displayed at the bottom right of the screen.
The ECG Module can provide four error messages: "NO ECG", "LEAD OFF", "ECG ERROR"
and "BAD ELECTRODE". These messages are displayed in red, in the place of Heart Rate when
they occur.
‰ NO ECG: ECG not connected or connected wrongly
‰ LEAD OFF: clamps are defective or not correctly placed on the patient
‰ BAD ELECTRODE: clamps are defective or not connected
‰ ECG ERROR: when a failure happens in the ECG software module. Freeze,
then unfreeze the system to work out the problem.
The Trigger mode allows the synchronization of 2D image. The softkey Trigger Off/1/1+2 is used
to disable/enable one or two triggers.
The ECG On/Off preference can be selected for each probe and saved in each probe setup.

10.12.01 OPERATING INSTRUCTIONS 3-95

3.1 7 EasyPrintÄ Options
These options are:
‰ EasyPrint™ B & W for SIGMA 110 systems; this option requires CINE Option.

‰ EasyPrint™ Color for SIGMA 330 systems.

The EasyPrint™ Options allow the user to print Patient Reports and ultrasound images. The
images must be previously saved on a memory card before printing. The printing process is done
while the system can continue to perform other tasks. This allows the user to work during the
images are printed.

3.1 7.1 Printing of images

3.17.1.1 Selection of images for printing

‰ Store the images to be printed on a memory card (SRAM), see Chapter 3.11.1, “Image
Storage and Freeze Menu”, on page 3-51.
‰ View the Panel of 16 images (thumbnails), see Chapter 3.11.2, “Archive: Display of Stored
Images”, on page 3-52.

19/11/00 10:53:35

SIMPSON: Left Ventricle„

Delete Del.All Undo
Image Images

‰ Select each image to print with the trackball and by pressing the “SELECT” key; the
number of selected images is displayed over the thumbnail; it defines also the position of
the image on the printed page.
‰ You can also press directly on the PRINT2 key: all the images from the current patient will
be selected and printed.

3-96 SIGMA 110/SIGMA 330 10.12.01

 19/11/00 10:53:35

1 3

4 2

SIMPSON: Left Ventricle„

Delete Del.All Undo
Image Images

‰ An image can be removed from the list at any time: just press on the “SELECT” key again
when it is highlighted (use the trackball). If the user unselects the image labelled “2”, the
thumbnail page is updated as shown below:

19/11/00 10:53:35

1 2

SIMPSON: Left Ventricle„

Delete Cancel Undo
Image Print

‰ To print the selected images, press on PRINT2.

Note that the image title is always printed when available.
Be careful, do not remove the memory card during this process; otherwise the print process will
be cancelled.

10.12.01 OPERATING INSTRUCTIONS 3-97

3.17.1.2 Print Deletion

The “Delete All Images” menu item is changed into “Cancel Print” during the print process. When
this key is selected, a confirmation dialogue box is displayed first. The print is cancelled if the
user validates it.

Do you want to cancel the printing process?

Yes No

Moreover, if the flashcard is removed while the print is in progress, the print is automatically can-
celled and an error message is displayed. See Chapter 5.5.17, “Error 16: Flashcard removed
while printing”, on page 5-21.

3.1 7.2 Printing of Report

Printing of Patient Report is available from the Report menu.

3-98 SIGMA 110/SIGMA 330 10.12.01

3.1 8 USB-LinkÄ Option
3.1 8.1 Overview
The USB-Link™ option allows the connection of the ultrasound scanner to a computer, and so
extends the KIPRISM capabilities. With USB-Link™, the SRAM memory card is recognized by
the computer as if it was a removable hard-disk. All the images, report and patient information
saved on it can be read from the computer.
Note that no more PCMCIA card reader is required to archive the SRAM memory card content
on a personal computer.

3.1 8.2 Compatibility

The USB-Link™ option is compliant with:
‰ MacOS 9 or upper,
® ®
‰ Microsoft Windows 2000 with Service Pack 3 installed

Please contact your local KONTRON MEDICAL representative for more information about sys-
tem requirements.

3.1 8.3 Usage example with Windows 2000

3.18.3.1 Device identification

When the SIGMA and the computer are not connected together, typically you may have the fol-
lowing view from your file Explorer.

10.12.01 OPERATING INSTRUCTIONS 3-99

When the computer and the SIGMA are connected together, the SIGMA is recognized as a
removable device.

3.18.3.2 List flashcard content

If clicking on the removable disk device whereas no flashcard is plugged in the SIGMA, the fol-
lowing message is displayed:

When a flashcard is plugged, its content is displayed, as shown below:

3-100 SIGMA 110/SIGMA 330 10.12.01

3.1 8.4 Read data from a computer
Once the flashcard has been recognized as a removable hard disk, any PCX or TXT file can be
read from the computer:
‰ from the file explorer, double-click on a file to open it.

‰ from a standard image viewer (Imaging) or a text editor (Notepad), open a file with the
File ->Open menu.

3.1 8.5 Copy data to the computer

To copy images and text files from the flashcard to the computer, just drag-and-drop the files to
copy from the file Explorer to the destination directory.

10.12.01 OPERATING INSTRUCTIONS 3-101

3.1 8.6 Interface with PACS
PACS can be interfaced with SIGMA 110 or SIGMA 330 when using USB-Link™. In this case,
data stored on the flashcard are imported and processed by the PACS. For more information
about the PACS software refer to the User Manual of the PACS software delivered with the sys-
tem.
Please contact your local KONTRON MEDICAL representative for information about supported
PACS.

3.1 8.7 Limitations

Only read accesses are allowed. In consequence, the following are forbidden from the computer:
• no flashcard format,
• no file can be modified, or deleted,
• no file can be created or copied,
• no file can be renamed,
• no directory can be created,
The flashcard organization must be solely managed by the SIGMA. If one of the above listed
actions are done anyway, then the SIGMA will not recognize these data and the PACS may not
import them. Therefore, the flashcard must be formatted from the SIGMA: saved data are then
lost.
The user will be responsible to preserve the flashcard content (no changes must be done from
the computer, only read and copy operations are allowed).
All the files the SIGMA writes on the flashcard are read-only. But, if the user intends to modify or
delete a file, the Operating System just warns him that the file is write protected, but the user can
delete or modify it anyway.

3-102 SIGMA 110/SIGMA 330 10.12.01

3.1 9 SonoWin Lite and SonoWin Basic PACS
3.1 9.1 Overview

3.19.1.1 SonoWin¾ Lite

SonoWin® Lite PACS1 software offers the following features:

‰ Transfer of patient information data and images between the SIGMA 110/330 and the
PACS
‰ Transfer of images in digital format (no loss of quality contrary to a frame grabber)

‰ Powerful database for fast patient sorting regardless the number of patients and images,

‰ Intuitive user interface and research criteria,

‰ Export and import of most commonly used image formats (.bmp, .pcx, .jpg, etc.),

‰ Fast access to images by a double click on images,

‰ Selectable backup frequency,

‰ Very reliable backup (impervious to dust, magnets, moisture, and shock) thanks to the
Magneto Optical Disk drive and disk delivered with the software.

1. Picture Archiving and Communication System.

10.12.01 OPERATING INSTRUCTIONS 3-103

3.19.1.2 SonoWin¾ Basic

In addition to SonoWin® Lite features, SonoWin® Basic PACS software offers:

‰ Transfer of calibration data and measurement between the SIGMA 110/330 and the PACS

‰ Flexible configurable report templates for reduced working time,

‰ Simple drag and drop to include images into a report.

3.19.1.3 Advanced features

Additionally, following options are available:

‰ Post Measurement Module for doing measurements on archived images

‰ DICOM-int for importing DICOM images

‰ DICOM-ext for exporting DICOM images

Please contact your local KONTRON MEDICAL representative for more information.

3.1 9.2 Start a Study

The correct assignment of individual data to a particular patient is based on a patient ID. This
unique identification is entered in the host ultrasound device under the “FOLDER N” field of the
patient ID page.

The simplest way to set up a new patient is to always create a patient record in SonoWin® first.
Then, before starting a new study on the ultrasound device, it is essential to press the “New
patient” icon (this will reset all the biometry and patient fields) and store the generated
patient ID in the “FOLDER N” field. The other patient data, such as name, date of birth etc., are
then automatically and correctly assigned in SonoWin® and do not have to be entered again in
the ultrasound device.

3-104 SIGMA 110/SIGMA 330 10.12.01

3.1 9.3 Save images, reports and patient information
During an examination, the operator can store patient data, report and images on a formatted
PCMCIA SRAM. Images are stored when the “Store” key is pressed in any freeze menu.

Reports and patient information are stored from any biometry page or from the patient ID page
when the “Store” key is pressed.

10.12.01 OPERATING INSTRUCTIONS 3-105

3.1 9.4 Transfer data to SonoWinÂ
Once relevant data have been stored on the PCMCIA SRAM, the transfer can be done. As previ-
ously mentioned, SonoWin® supports two modes of operation: data transfer via PCMCIA SRAM
card or via USB cable connection.

3.19.4.1 Transfer via a PCMCIA SRAM

When this operating mode is used, the SRAM must be inserted in the PCMCIA drive located on
the computer. When SonoWin® is running, the system reads the relevant data on the card and
the KIPRISM data are automatically stored in the correct SonoWin® records. When the PCMCIA
SRAM is inserted again in the SIGMA, the memory card content is automatically erased.
Note that if certain measurements cannot be assigned automatically to SonoWin® measurement
records (e.g. in case of user-defined measurements), the assignment can be performed manu-
ally. Please refer to “SonoWin®-2000 User’s Manual”.

3.19.4.2 Transfer via a USB connection

This operating mode is based on a USB cable connection between the ultrasound device and the
computer. Unlike the operating mode described above, the SRAM card remains in its drive on the
ultrasound device all the time.
There are several ways to start a transfer from the SIGMA to SonoWin®:
‰ press on the “Transfer” key in any freeze menu

The data currently stored on the memory card are transferred to SonoWin®.

3-106 SIGMA 110/SIGMA 330 10.12.01

 ‰ start a new patient study: press on the new patient icon from the patient ID page

The data relevant to the previous patient are automatically transferred.

‰ power off the SIGMA: if KIPRISM data are stored on the SRAM, the operator is prompted
to transfer data.

As soon as SonoWin® has successfully read all the information stored on the card, the input data
will be automatically deleted from the SRAM card by the ultrasound device. If individual measure-
ments cannot be assigned automatically, the procedure for the manual assignment is the same in
this operating mode as in the mode described above.
Note that the following error message may be displayed by SonoWin® after having started.

10.12.01 OPERATING INSTRUCTIONS 3-107

This means that SonoWin® can not work because it has not full accesses to the PCMCIA card.
The setup on PCMCIA card accesses must be modified in the preferences menu
(“Setup”>”Prefs”>”System”>”PCMCIA card”) and the option “Full accessed” must be selected.

Selecting this option is absolutely essential otherwise (option “Read only accessed” is selected)
the data transfer between the ultrasound device and the PC via a USB cable connection is not
possible.

3-108 SIGMA 110/SIGMA 330 10.12.01

3.1 9.5 Data Assignment
This chapter is only valid for the Basic version of SonoWin®.
Important note: any SonoWin® user with administrator privileges can change any data assign-
ment and so this document may not be up to date compared to modified settings. Here only the
default settings are described.

3.19.5.1 Assignment of KIPRISM data to existing SonoWin¾ parameters

KIPRISM data are assigned to SonoWin® parameters using a conversion table. To check which
values are assigned and which ones are ignored during this process, click on the KIPRISM icon
in the SonoWin® main window or select the menu item “Window” – “Kiprism”.
This opens a window displaying the results of the assignment process. Please refer to
“SonoWin®-2000 User’s Manual” for more details.

3.19.5.2 Assignment of KIPRISM data to user-defined SonoWin¾ parameters

Some KIPRISM data are not assigned to SonoWin® parameters. The user can assign them to an
existing parameter in an existing chapter (see Section 3.19.5.1 on page 109), or create a specific
chapter and/or a specific parameter. To do so, select the menu item “Window” – “Measured Val-
ues” or click on the corresponding icon in the SonoWin® main window, and then select
“Configuration” in the system menu.
Please refer to “SonoWin®-2000 User’s Manual” for more details.

3.19.5.3 Multiple Assignment of KIPRISM data to SonoWin¾ parameters

One SonoWin® parameter may be mapped to more than one KIPRISM data (see Appendix K for
a detailed list). The assignment of some measurements from SIGMA to the same SonoWin®
value is intended, because mostly only one of these is used.
If, in rare case, there is a need for a customer to use two or more of these values simultaneously,
he can assign them to user-defined measurements, and proceed as described below:
‰ Open the measurement table (click )
‰ Open “Configuration” in the system menu

‰ Mark the chapter where an item has to be add, or create a new chapter

‰ Add the item(s)

‰ Close this window.

‰ Assign the transferred values to the newly defined measurements, by clicking on .

Please refer to “SonoWin®-2000 User’s Manual” for more details.

10.12.01 OPERATING INSTRUCTIONS 3-109

3.20 Integrated PC (SIGMA 330 Excellence)
3.20.1 Overview
The SIGMA 330 Excellence includes a high-end PC running Microsoft® Windows® 2000 Profes-
sional; the keyboard and trackball of the SIGMA can be used as a standard PC keyboard and PC
mouse; the Universal Serial Bus (USB) interface is used to perform the communication link
between the SIGMA system and the integrated PC.
The following drawings show the PACS configuration and 3D tool configuration:

LCD monitor
Keyboard, trackball and
SIGMA 110/330 images data
(USB interface)
PC with PACS

Frame Grabber
Video signal

LCD monitor

SIGMA 110/330
Keyboard and trackball data
(USB interface)

PC with 3D tool

3.20.2 SAFETY PRECAUTIONS

Please review the information in this section before using the Integrated PC. Please
also review the information in the user manuals of the 3D and/or PACS software.
Maintenance, service, changes of the device, installation, upgrades, setups may only be
performed by KONTRON MEDICAL trained and authorized personal. Warranty might be
void.
Technical documentation is worthless without adequate training. Please contact KON-
TRON MEDICAL for further information.
DO NOT INSTALL ANY OTHER SOFTWARE. Contact your local KONTRON MEDICAL
representative if you want to install software.
Do only use accessories and replacements which are recommended by KONTRON
MEDICAL.
Do not remove disks from the disk drive (optional) during disk read and write operations
(when the disk drive light is on). Removing a disk during read and write operations can
cause incomplete storage of data files, resulting in data loss.
KONTRON MEDICAL is not responsible for problems attributable to unauthorized
changes, additions or deletions to KONTRON MEDICAL software or hardware, or unau-
thorized installation of third party software.
KONTRON MEDICAL is not responsible for loss of data; KONTRON MEDICAL recom-
mends that you back up regularly your data.

3-110 SIGMA 110/SIGMA 330 10.12.01

3.20.3 Entering PC remote control mode
In standard mode, SIGMA keyboard and trackball control the ultrasound system. A specific key
sequence has to be entered on the keyboard of the SIGMA to remote control the PC:
SHIFT+SELECT.
Once in PC remote control mode, trackball actions and most of the keyboard actions are sent to
the PC like a standard mouse/keyboard. When the user switches to PC mode keyboard, a spe-
cific menu is displayed on the SIGMA screen.

3.20.4 PC remote control features description

The trackball emulates a three buttons mouse.

Mouse middle key

Mouse left key Mouse right key

Mouse move
Mouse double left
key action
(double-click)

3.20.5 Leaving PC remote control mode

PC remote control can be left at any time by pressing SHIFT+SELECT, F5 or FREEZE .

3.20.6 Keyboard in PC mode

3.20.6.1 Introduction

This section defines the use of the SIGMA keys in PC mode. In PC mode the SIGMA keyboard
becomes a PC one, but some keys are still affected to SIGMA functions.

3.20.6.2 SIGMA keys

The following keys remain assigned to the SIGMA:

‰ Sliders,

‰ B-gain, D-gain,

‰ DEPTH,

‰ PRINT 1,

‰ FREEZE,

‰ MENU and POWER OFF

3.20.6.3 PC keys

Four set of keys can be distinguished:

10.12.01 OPERATING INSTRUCTIONS 3-111

 ‰ standard keys as letters and digits.
‰ control keys as CTRL, ALT.

‰ “menu keys” allowing access to function keys and some special characters.

‰ trackball keys and events.

The following scheme shows a SIGMA keyboard with, in white, the keys used for the PC key-
board and trackball, and their affectation. The keys in grey are not used for the PC keyboard and
trackball but for the SIGMA as usual.

MENU
-
+

1 2 3 4 5 6 7 8 9 0

q w e r t y u i o p

a s d f g h j k l

z x c v b n m SPACE

ESC SELECT CAPS

TAB
CTRL
INS
ALT
DEL
Alt GR

MEASUREMENT

PRINT1

PRINT2

3-112 SIGMA 110/SIGMA 330 10.12.01

Menu keys
The menu keys allow to access the keys which are not accessible directly from the SIGMA key-
board or are not intuitive enough. They allow also to hide such application specific key combina-
tions.
They are presented on 2 menu pages:

Start/End Show/Hide End Back to

Scan. CFM win. now SIGMA

F1 F2 F3 F4 F5

F6 F7 F8 F9 F10

Application specific menu key can help the user by allowing direct access to complex key
sequences or specific controls. These specific keys are:
‰ Start / stop scan, Used by 3D software
‰ Show/hide CFM window. Hide or show CFM window and wall filter marker.
‰ End now Ends the shut down process without waiting for the PC shut-
down (only valid in a shut down sequence).
WARNING: use this key with care. Hard disk of the PC
can be damaged and open files will not be saved.
Shift keys
Using shift key combination allows access to country specific codes.
Lower, upper case
Usually, we use the shift key combination to select an upper case character. Here on the SIGMA
keyboard the user must press CAPS LOCK key to select upper case mode and then press it again
to go back on lower case mode.
Print 2 key
This key is affected in PC mode to send a print command to the active application.

3.20.6.4 Stickers for Keyboard

Keys as CTRL and ALT are frequently used in a PC user interface, so they have to be found
easily on the keyboard. Their affectation is indicated on the keyboard by using stickers as shown
below.
ESC ID
Caps

BODYMARK SETUP
Ctrl Tab
ANNOT PROBE
Alt Ins
REPORT MAGNIFY
Alt Gr Del

10.12.01 OPERATING INSTRUCTIONS 3-113

3.20.7 Errors and warnings
When the user intends to enter the PC mode and when no PC has been detected on the USB
port a warning message is displayed. For more information, refer to Chapter 5.4.4.16, “Warning
25: No PC connected to USB port”, on page 5-17.

3.20.8 PC power on
The integrated PC starts automatically when the system is powered on. When the following win-
dow is shown the user has to press on CTRL+ALT+DEL and enter his user name and password in

the LOGIN window. The default user name is "sigma" with the "sigma" password.

Please contact your local KONTRON MEDICAL representative to change the user name and/or
the password or to log on the system as "Administrator".

3.20.9 PC power off

During the shut down process requested by the user, commands are sent throughout the USB
interface. SIGMA sends a CTRL+ALT+DEL key sequence to the PC and then waits for the PC shut
down completion. At this moment the user is responsible of closing and saving his documents.
He can use the SIGMA keyboard and trackball which are automatically affected to PC mode.
Select "Shutdown" in the different dialogues displayed.

When the PC has finished its shutdown process, the SIGMA system is automatically powered off.

3-114 SIGMA 110/SIGMA 330 10.12.01

3.20.1 0 3D VascularViewÄ and 3D FetalViewÄ
The settings have been specially adapted to easily control the 3D software directly from the
SIGMA, using menu keys or the footswitch. This chapter describes only these shortcuts.
For more information about the 3D software refer to the User Manual of the 3D software deliv-
ered with the system.

3.20.10.1Menu keys

Refer to “Menu keys” on page 3-113.

3.20.10.2Foot switch

The foot switch allows the user to send some commands to the SIGMA. In PC mode the two but-
tons are affected according to the following:
‰ acquisition mode:
• left button -> nothing
• right button press event -> start scan and stop scan
‰ review mode (when acquisition is stopped):
• short step (< 1 second) on the right button -> open save dialogue,
• long step (> 1 second) on the right button -> open delete dialogue,
• step on the right button -> OK
• step on the left button -> CANCEL

3.20.1 1 PACS option

For more information about the PACS software refer to the User Manual of the PACS software
delivered with the system.

3.20.1 2 Connection to a Network

The SIGMA 330 Excellence provides a RJ-45 10/100 Mbps Ethernet connector. Please contact
your local KONTRON MEDICAL representative to change the parameters of the Network con-
nection.
Never connect Network (RJ-45) directly to the system; use a medical grade network
isolator which must comply with IEC 601 -1 specifications. Wrong connections may
compromise the electrical safety of the system. KONTRON MEDICAL provides a
medical grade isolator on request, see Chapter 6.3, ÞAccessoriesß, on page 6-5 for
ordering.

3.20.1 3 Installation of peripherals

Please contact your local KONTRON MEDICAL representative to install peripherals on the sys-
tem.
Never connect additional peripherals directly to wall outlets; use the outlet availa-
ble in the cart or a medical grade isolating transformer which must comply with IEC
601 -1 specifications. Wrong connections may compromise the electrical safety of
the system. KONTRON MEDICAL provides a medical grade isolating transformer
on request, see Chapter 6.3, Þ Accessoriesß, on page 6-5 for ordering.

10.12.01 OPERATING INSTRUCTIONS 3-115

 This page is intentionally left blank

3-116 SIGMA 110/SIGMA 330 10.12.01

 4. MAINTENANCE

10.12.01 MAINTENANCE 4-1

4-2 SIGMA 110/SIGMA 330 10.12.01
4.1 Cleaning
4.1 .1 Probes
It is recommended that all probes be cleaned, adequately disinfected between patients.
Gently clean the probe with a very mild detergent solution and a slightly dampened cloth.
Do not apply pressure.
Never immerse the probe in any liquid, except for disinfection (see Chapter 4.2, “Disinfection”, on
page 4-5).

4.1 .2 TV Monitor
Caution, TV Monitor screen includes an anti-reflecting coating.
For cleaning, spray anti-static screen cleaner (e.g. cleaning products for computer), wiping with
soft wiper.

4.1 .3 EYE-Q 300M Monitor

• For cleaning monitor cover it is recommended to use Johnson Glass Clue; it is possible to use
Alkaline cleaner or IPA (Isopropylalcool).
• For cleaning monitor panel it is recommended to use Sanwa CD-41NT.
• For cleaning monitor air filter any IPA can be used.

4.1 .4 Keyboard
The top grid and the silicon layer of the keyboard and the trackball can be easily removed for
cleaning; they are washable.
To remove the grid, press it as shown in figure 4-1, “Keyboard Cleaning”, on page 4-3 and pull it
forward. Then, the silicon layer and the trackball are accessible.

Figure 4-1 : Keyboard Cleaning

10.12.01 MAINTENANCE 4-3

4.1 .5 Instrument
Clean the surface of the SIGMA 110/330 with a dry cloth. If more extensive cleaning is required,
switch off the instrument and disconnect the power cord. Use a slightly dampened soft cloth and
very mild detergent solution to clean exterior surfaces.
Never use strong solvents, slosh water on the instrument, or immerse any part of the instrument
in any liquid.
Never remove the protective covers of the SIGMA 110/330. Hazardous voltage levels exist.
If more extensive cleaning is required, contact your Customer Service Representative.

4-4 SIGMA 110/SIGMA 330 10.12.01

4.2 Disinfection
It is recommended that all probes be cleaned, adequately disinfected between patients.
All probes may be disinfected with Cidex 1.
The recommended duration for disinfection is 10 minutes.
For detailed information on disinfection of probes and duration of disinfection refer to the probes
manufacturer's recommendations.
For special applications and specific transducers refer to their proper Operating Manual.
The following figure shows the immersible part for the different probe types

3.5GP/5.0GP/7.5GP/14PV PEN2/PEN4/PEN8/TCD2

Figure 4-2: Immersion limit of Annular Sector and Pencil probes

1. Cidex is a Trademark of Johnson & Johnson

10.12.01 MAINTENANCE 4-5

.

7.5LV/7.5LVS 3.5CV

5.0LV 3.5MC/6.5MC

Figure 4-3: Immersion limit of Linear/Convex probes

4-6 SIGMA 110/SIGMA 330 10.12.01

 6.5MR/6.5VMC/6.5EV

Figure 4-4: Immersion limit of endocavitary probes

10.12.01 MAINTENANCE 4-7

4.3 Repairs and Maintenance
The SIGMA 110/330 system is designed to be maintained by factory-trained Customer Service
Representatives.
The manufacturer, assembler, installer or importer considers himself responsible for the effects
on safety, reliability and performance of this product only if:
• Assembly operations, extensions, readjustments, modifications or repairs are carried out by
personnel authorized by the Manufacturer.
• The electrical installation of the facility where the product is used complies with the IEC
requirements or Electrical Codes of the country.
• The product is used in accordance with the instructions of use.

4.3.1 User Maintenance

The user of SIGMA 110/330 units can do some maintenance by himself.

4.3.1.1 Air filter replacement

Depending on the system configuration and on the environmental conditions, it is necessary to

replace the air filter more or less regularly:
• When working in non polluted environments, the air filter must be replaced twice a year.
• When working in very polluted environments, it must be replaced every month.
It is mandatory to replace the air filter when the "Warning 18" is displayed.
Note that a worn and cleaned filter will never be as efficient as a new one.
It is recommended to replace the filter by the KONTRON MEDICAL genuine part (PN: 471059).
The air filter is located on the backside of the instrument. To replace it:

Figure 4-5: Air filter replacement

• Pull on the air filter grid as shown on the figure 4-5 to remove it.
• Remove the used filter.
• Place the new one.

4-8 SIGMA 110/SIGMA 330 10.12.01

 • Position back the air filter grid.

4.3.1.2 Remote Control Unit

The Remote Control Unit is powered by two "LR03.AAA.MN 2400" batteries. Replace batteries
only with batteries of the same type.

4.3.2 Manufacturer Maintenance

A yearly maintenance visit is advisable. It should be carried out by personnel authorized by the
Manufacturer.

10.12.01 MAINTENANCE 4-9

4.4 Product Recycling and Disposal
The SIGMA 110 and SIGMA 330 contains electronic boards, batteries and tubes.

Before you dispose the system, these boards, batteries and tubes must be removed and dis-
carded according to local regulations or recycled where facilities exist. Contact your local KON-
TRON MEDICAL company or agent for further informations.

For battery disposal contact your local waste disposal facility.

4-10 SIGMA 110/SIGMA 330 10.12.01

 5. TROUBLESHOOTING

15.10.01 TROUBLESHOOTING 5-1

5-2 SIGMA 110/SIGMA 330 15.10.01
5.1 Handle Error and Warning Messages
This troubleshooting procedure lists the checks for remedying simple defects. Extensive trouble-
shooting is explained in the technical service manual and is only performed by the local service
engineer.
Points to check by the user to avoid Error and Warning Messages:
• Check control settings. Incorrect control settings may suggest a fault that does not exist. If
there is any question about the correct function of any control, consult Sections 2 and 3 of this
manual.
• Check connections and fuses.
• Check cables for proper interconnection.
• Disconnect the unit from the power source and check the fuses in the power source recepta-
cle (if the receptacle is fused).
• Check monitor operation.

15.10.01 TROUBLESHOOTING 5-3

5.2 Introduction and Rules
This chapter contains a description of the different warnings and errors managed by SIGMA 110/
330.

5.2.1 Rules
Warnings and Errors messages are written:
• in a dialogue box

Warning 5:Flashcard not present.

Please plug a SRAM flashcard

OK

• directly on the screen (in red on colour monitors)

example: NO ECG is written on the bottom right side of the screen

5.2.2 Definition
Different terms to qualify the displayed messages are used in this document:
• Status messages: have no effect on the system, but inform the user of a bad manipula-
tion.
• Warnings: signify to the user that the system is in an incorrect state, or that the user has
performed a non authorized action.
• Errors: inform the user of a system failure due to hardware problems (broken board) or
software failure.

5.2.3 Remarks
• The different messages (warnings and errors) are displayed in English.
• Doppler board is either SP_DOP or COL_DOP board

5-4 SIGMA 110/SIGMA 330 15.10.01

5.3 Status Messages
5.3.1 ECG
When ECG mode is active different error cases can be detected: the different ECG warning
messages are always displayed on the bottom right side of the screen in red.
Date & Time
General information and Patient name

Grey scale
Technical data

Zoom indicator

Meas. result

ECG message

Tilt Body Mark.

icon Menu Mag.
icon

5.3.1.1 ECG Activation

There are two ways to activate the ECG mode the user should:
• load the cardio setup for the current probe
• switch the ECG ON via the PREF menu

5.3.1.2 NO ECG Message

No ECG
Angle Dual Zoom Freq Biopsy

2D Inv. Right AddFocus Trigger

NO ECG is displayed when ECG mode is active and

• ECG is not connected or not correctly connected
• there is a defect serial port on the SIGMA
• there is a defect ECG
To correct this problem the user should verify the ECG connection, if the problem persists he
should call the service team.

15.10.01 TROUBLESHOOTING 5-5

5.3.1.3 LEAD OFF Message

Lead Off
Angle Dual Zoom Freq Biopsy

2D Inv. Right AddFocus Trigger

LEAD OFF is displayed when ECG mode is active and

• clamps are defective
• clamps are not correctly set on the patient
- Red clamp on right arm
- Yellow clamp on left arm
- Black clamp on right leg
To correct this problem verify the clamps position on the patient or verify the clamps, or call the
service team, if the problem persists.

5.3.1.4 BAD ELECTRODE Message

Bad Elect
Angle Dual Zoom Freq Biopsy

2D Inv. Right AddFocus Trigger

BAD ELECTRODE is displayed when ECG mode is active and

• clamps are defective
• clamps are not connected
To correct this problem connect the clamps to the patient or verify the clamps, or call the service
team, if the problem persists.

5.3.1.5 ECG ERROR Message

ECG Error
Angle Dual Zoom Freq Biopsy

2D Inv. Right AddFocus Trigger

ECG ERROR is displayed when ECG mode active and a failure in the ECG software module
happens.

5-6 SIGMA 110/SIGMA 330 15.10.01

To correct this problem, freeze and unfreeze the system. Call the service team, if the problem
persists.

5.3.2 Measurement and Biometry

5.3.2.1 Invalid Results

Software performs checking of measurements for proper range before displaying results.
• Out of range measurement result
The “out of range” result is displayed with question marks (?) or sharp marks (#).
1D ###.## mm
BDP 11.5 mm
EFA ??w?d

Distance BPD HC AC TAD

APD FML THD Hul Undo

In this case the user restarts the current measurement, to have a valid result (denominator
equal to 0, or too high measurement result).
• Out of range Ob/Gyn biometry result
The current measurement result is out of range for the foetal age computation.

Value is out of limits

Limits: from 4.2 to 77.8 mm

OK

In this case the user restarts the current measurement, to have a valid result.
• Invalid biometry result
An invalid result (negative computed mass, invalid date, ...) is displayed as ###.## or ###
according to the result type.

5.3.2.2 Other Cases

When restoring users preferences from flash card, the compliance of the restored data is
checked. In case of incompatibility (inconsistent values restored) the following message is dis-
played:

15.10.01 TROUBLESHOOTING 5-7

 Some Ob/Gyn user’s preferences
are no more valid.
Restoring default values

OK

5.3.3 Transmit Voltage Indicator

This symbol message (TVI) warns the user that the Transmit High Voltage for probes is out of
range. If the message persists, contact your local service representative.
In live mode, the system continuously checks the probe high voltage in all modes except in CFM
while the probe voltage continuously changes from the 2D voltage to the Doppler voltage.
When the Probe high voltage is outside the limits, the high voltage warning icon is displayed on
screen.
Date & Time
General information and Patient name
Grey scale

Technical data
Zoom indicator

Meas. result

ECG message

Body
Tilt
icon Menu Mag. Mark.
icon

The first time the problem occurs the ÚWarning 24: Transmit Voltage is not under controlÚis dis-
played (see page 5-16)

5-8 SIGMA 110/SIGMA 330 15.10.01

5.4 Warnings
5.4.1 Start-up checks

5.4.1.1 Transducer Check

At system start-up or for each transducer change, the current plugged transducers codes are
checked according to the current recognised transducers list.

P-2 P-3 Invalid Invalid P-6

3.5GP 7.5GP Probe Probe 3.5CV

If one of the plugged transducer is not included in this list, on the probe menu “Invalid Probe” is
displayed instead of the current probe name, or the transducer name is displayed in grey.
• Transducer name is displayed in grey, when:
• the user wants to use a pencil probe without a Doppler board
• a PEN 2 MHz transducer is plugged without the Cardio option.
• “Invalid Probe” can be displayed if:
• the current probe is not recognised by the system (transducer no more or not currently
available)
• bad transducer code is read due to probe or transducer cable defect
• the connector on the system is broken or has contact problems
• LA DSP sends bad transducers codes
If one of the both message persists, the user must inform the service team.

5.4.1.2 Warning 0: NOVRAM reset

After a software upgrade the non volatile RAM (NOVRAM) is reset to guarantee its content.
So before upgrading the software, the current configuration will be saved on the delivered flash
card or SRAM (menu <SETUP>, <PCMCIA CARD>, <BACKUP CONFIG>), and restored after
software upgrade (menu <SETUP>, <PCMCIA CARD>, <RESTORE CONFIG>).
Note: the restore operation can not be done for a version below V5.00 (i.e. V2.50) to a V 5.XX
version (Chapter 5.5.2, ÚError 1: Can not restore backed up configurationÛ
, on page 5-18)

Warning 0: NOVRAM reset

The software has been upgraded.

The NOVRAM has been reset
The user setups are lost!!

OK

15.10.01 TROUBLESHOOTING 5-9

5.4.1.3 Warning 1: Backed up RAM reset

Two different cases can involve a backed up RAM (NOVRAM) reset:

• the backed up RAM content is corrupted (checked at system start-up)
• failure in the backed up RAM battery

Warning 1: Backed up RAM reset

The backed up RAM has been reset
The user setups have been lost!!
Please signal this problem to your
service team.

OK

5.4.1.4 Warning 2: Transducer handling advise

Unplugging a transducer in live mode may generate some damages on the transducer or on the
board, so when the user unplugs the current transducer in live mode the following message is
displayed and the system is frozen.

Warning 2:Transducer handling advise

Please do not unplug transducers
in live mode.
Thank you!

OK

Remark: this message can be displayed when the transducer cable is broken (can not read the
transducer code).

5.4.2 System Configuration Check

5.4.2.1 Warning 3: Hardware board version

During system start-up a check of the different available boards revision (software version
dependant) is made. If one of the board (VLCUS, LA, COL_DOP/SP_DOP) is not in the list of the
current available board revision, a warning message is displayed just after system start-up to
inform the user that one or more of the board should not be used with this software version.

Warning 3: invalid hardware detected

Invalid LA board version 01

OK

5-10 SIGMA 110/SIGMA 330 15.10.01

By pressing on any key, the dialogue box disappears.

This message is displayed at each system start-up until the invalid board is modified or replaced
by the service team.

5.4.2.2 Warning 4: Invalid system configuration

For each type of system a list of the available boards is defined. At system start-up, the different
boards are checked according to the current type, if some boards are found that are normally not
included in this system type, a warning is displayed.
e.g: system type: SIGMA 110 Light on which no COL_DOP board should be connected

Warning 4: Invalid configuration

=> SIGMA 110 Light
COL_DOP board: PRESENT

OK

This message is displayed at each system start-up until the non authorized hardware is removed
by the service team.

5.4.3 Flash card and SRAM

5.4.3.1 Warning 5: Flash card not present

Displayed when trying to store images without a flashcard plugged. A SRAM should be plugged

Warning 5:Flashcard not present.

Please plug a SRAM flashcard

OK

5.4.3.2 Warning 6: Flash card is write protected

The current plugged flash card is write protected, the user should change the flash card or
remove the write protection.

Warning 6:Flashcard is write protected

OK

15.10.01 TROUBLESHOOTING 5-11

5.4.3.3 Warning 7: SRAM battery status

The SRAM battery state is checked when the user plugs a SRAM. If the SRAM battery is low or
empty, one of the following message is displayed and the user should replace the battery

Warning 7: SRAM status battery Warning 7: SRAM status battery

is low. Can maintain data integrity. is empty. Can not maintain data integrity.
Change battery ASAP. Change battery now.

OK OK

When the second message is displayed (empty battery), the saved data could be lost.
The battery state can also be checked, via the PCMCIA menu.

5.4.3.4 Warning 8: No data to restore

This warning is displayed when the user tries to restore a configuration from an empty flashcard.

Warning 8: No data to restore

OK

5.4.3.5 Warning 9: Invalid flashcard for archive

A formatted flashcard is plugged instead of a SRAM and the user wants to archive images. A
SRAM must be plugged.

Warning 9: This is not a SRAM

Archive is not possible with this flashcard

OK

5-12 SIGMA 110/SIGMA 330 15.10.01

5.4.4 Miscellaneous checks

5.4.4.1 Warning 10: Invalid VLCUS serial number

This warning message is displayed at start-up if the serial number of the VLCUS board is not
correct.

Warning 10: Invalid VLCUS serial number

VLCUS serial number not defined

OK

If the message persists, the user must inform the service team.

5.4.4.2 Warning 11: Printer not responding

This message is displayed when the printer is not responding. The user must check the printer
(broken printer, printer Off, ...), the printer cable.
If the problem persists, the user must inform the service team.

5.4.4.3 Warning 12: Invalid configuration key

This message is displayed when the user enters an invalid configuration key from the preference
menu.

Warning 12: Invalid configuration key

Configuration key is invalid, no option
will be activated

OK

5.4.4.4 Warning 13: Name for a label list already exists

This message is displayed when the user enters a label list name that already exists.

Warning 13: A list with the name

you specified already exists.
Enter a new name.

OK

15.10.01 TROUBLESHOOTING 5-13

5.4.4.5 Warning 14: EasyPrint option is no more available

This message is displayed when the EasyPrint option has been temporary set (with a service
dongle) and is no more available. This message is displayed after the start-up.

Warning 14: EasyPrint option.

This option is no more available.
. has expired.
The date of validity

OK

5.4.4.6 Warning 15:

This message is displayed when anyone tries to change the date of any “not for sale” version. A
checksum to test software data integrity has been implemented to prevent hazardous modifica-
tions.

Warning 15:
The date of the version is not valid.

OK

5.4.4.7 Warning 16: Invalid time renting key

This message is displayed when an invalid time renting key is entered.

Warning 16: Invalid time renting key

Time renting key is invalid, no new
time will be activated

OK

5.4.4.8 Warning 17: Invalid time or date

At start-up, the system check the date and the time. If one of both is invalid then this message is
displayed to indicate that the date and time must be updated.

5-14 SIGMA 110/SIGMA 330 15.10.01

 Warning 17: Invalid Time or Date
Time or Date must be updated

OK

5.4.4.9 Warning 18: Internal temperature too high

Periodically, the system checks for its internal temperature. If a too high temperature is measured
for a long period the following message will be displayed..

Warning 18: Internal temperature too high

Change air filters as soon as possible

OK

It is displayed each 5 minutes until the internal temperature returns to a acceptable temperature
(below 65°C). This message is also displayed at system power up, if the internal temperature is
too high (65°C or more)

5.4.4.10 Warning 19: Time renting usage has expired

The following message is displayed when the usage duration has expired: the system is locked
until the user contacts the sales service to buy new hours.

Warning 19: There is no more time left in

your time renting contract.
Please contact your sales service.

OK

5.4.4.11 Warning 20: Internal temperature too low for mechanical transducers

To prevent damages on mechanical transducer, this warning is displayed if internal temperature

is too low (below 16°C).

Warning 20: Internal temperature too low

Mechanical transducers can be damaged,
if used at low temperature.

OK

Note: the system temperature is displayed in the System Info.->Boards window.

15.10.01 TROUBLESHOOTING 5-15

5.4.4.12 Warning 21: File is too long

This warning is displayed when the image file to save on the flashcard is too long (greater than
192 kB).

Warning 21: File is too long.

Cannot store the image.

OK

5.4.4.13 Warning 22: Not enough place on SRAM

This warning is displayed when there is no more room on the flashcard to save a file (image,
report save, ...).

Warning 22: Not enough place on SRAM.

Cannot store the image.

OK

5.4.4.14 Warning 23: Undefined Patient Name

This warning can be displayed only when the KIPRISM option is on. It is displayed the first time
an image is saved with an undefined patient name.

Warning 23: Patient Name is not defined.

OK

5.4.4.15 Warning 24: Transmit Voltage is not under control

This warning is displayed the first time the probe high voltage check fails (see Chapter 5.3.3,
“Transmit Voltage Indicator”, on page 5-8).

Warning 24: Transmit voltage is not

under control

OK

5-16 SIGMA 110/SIGMA 330 15.10.01

5.4.4.16 Warning 25: No PC connected to USB port

When the user intends to enter the PC mode and when no PC has been detected on the USB
port the following warning message is displayed.

Warning 25: No PC connected on USB port.

OK

15.10.01 TROUBLESHOOTING 5-17

5.5 General Failures and Errors
A system general failure can be caused by hardware, software or transducer failure. All the errors
described below are the most important errors which could happen during the system use. For
some of them a restart of the system is involved.
Remark: the user should press on any key to acknowledge the message.

5.5.1 Error 0: Internal unexpected interrupt

Internal and unexpected CPU errors are displayed with a generic “Fatal Error” dialogue box.
This error is displayed when an unexpected interrupt raise or when an internal protected mode
violation is detected. CPU registers and interrupt number are displayed in the dialogue box.
If this message is displayed, the user must send this information (video printout,...) to the service
team. This will help the development team to correct the problem.

Error 0: Fatal Error

INT:XX CS:EIP:XX:XXXXXXXX ESP:XXXXXXXX

EFL:XXXXXXXX EAX:XXXXXXXX EBX:XXXXXXXX
ECX:XXXXXXXX EDX:XXXXXXXX ESI:XXXXXXXX
EDI:XXXXXXXX EBP:XXXXXXXX

RESTART

5.5.2 Error 1 : Can not restore backed up configuration

Error 1: Can not restore backed up

configuration

The flashcard content is not compatible

with the current software version.

OK

This message is displayed when the user tries to restore from a flashcard a backed up configura-
tion that is not compatible with the current software version.
The configuration must be set manually by the user and saved again on the flashcard.

5-18 SIGMA 110/SIGMA 330 15.10.01

5.5.3 Error 2: Tracking problem - Fatal error
In case of a fatal error due to a transducer or a hardware problem, the following message is dis-
played and the system will be shut down after the user acknowledge the message.

Error 2: Fatal error

Your transducer does not track
the intended position.
Please signal this error to your service
team.
System will be shut down.

OK

Different causes can produce this error:

• Endocavity probe temperature exceed 41° C: cool the transducer and restart the system
• Mechanical transducer broken or locked: e.g transducer motor problems
Call service to signal probe problem
• Problem on probe cable
• Problem on VLCUS board

5.5.4 Error 3: Memory allocation error - Fatal error

The memory allocation error message do not cause a lock of the system, but the current action
(e.g add new annotation) can not be performed. If the user wants to use this function, he should
restart the system.
If the problem persists, the user should inform the service team.

5.5.5 Error 4: Divide by 0 - Fatal error

The divide by 0 error message is displayed when a divide by 0 happens in the software (e.g cor-
rupted stack, corrupted data by stack overflow, ...). When its happens the system is locked and
the user should restart it by using the switch ON/OFF button.
If the problem persists, the user should inform the service team.

5.5.6 Error 5: Communication error

An error has occurred on the COM1 serial port. If the problem persists, the user should inform
the service team.

5.5.7 Error 6: Flash card read error

The content of the flashcard can not been read, it may be broken. The user should change the
flashcard. If the problem persists, the user should inform the service team.

5.5.8 Error 7: Flash card write error

The system can not write on the current plugged flashcard:
• the flashcard is write protected, the user should remove the write protection
• the flashcard is broken, the user should change the flashcard.

15.10.01 TROUBLESHOOTING 5-19

If the problem persists, the user should inform the service team.

5.5.9 Error 8: Invalid flash card type

The current plugged flashcard is not recognised by the system. The user should use a recom-
mended flashcard. (see Chapter 6.3, “Accessories”, on page 6-5).

5.5.1 0 Error 9: Ob/Gyn restore error

When restoring users preferences from flashcard, the compliance of the restored data is
checked. In case of incompatibility (inconsistent values restored) the following message is dis-
played:
Error 9: Some Ob/Gyn user’s preferences
are no more valid.
Restoring default values

OK

5.5.1 1 Error 1 0: Flashcard not correctly formatted

The SRAM format failed, or there is a problem with the current SRAM (archive). Re-format
SRAM. If problem persists, SRAM is broken and should be changed

Error 10: Flashcard is not

correctly formatted

OK

5.5.1 2 Error 1 1 : Internal Communication - Fatal error

Internal communication error happens when the host does not receive message acknowledge-
ment from one of the DSPs. After a time out, the “internal communication” error message is dis-
played. To acknowledge this message the user presses on any key and a message informs the
user that the system will be powered off.
This error can happen when one of the DSPs has been reset due to software or hardware prob-
lems. If this problem persists, the user should call the service team.
To help the service team to find the cause of this problem, the user must press on the <H> key
(when dialogue is displayed), and printout the current displayed screen. This screen contains
information concerning the last sent messages.

5.5.1 3 Error 1 2: Cannot program TMPAVG

The TMPAVG (temporal average) is programmed at system start-up. If an error is detected (bro-
ken flash PROM, contact problems on it, etc., this error message can be displayed:
• when a new software is downloaded
• when the system is re-configured (with a new configuration key)
If this message is displayed, the user must inform the service team, its system may have a hard-
ware problem.

5-20 SIGMA 110/SIGMA 330 15.10.01

5.5.1 4 Error 1 3: CFM Frame Filter LUT Error
At start-up, the frame filter LUT content is checked and updated if needed.
This error is displayed when the LUT can not be reprogrammed; this is usually due to a hardware
problem.
If this message is displayed, the user must inform the service team.

5.5.1 5 Error 1 4: CFM Function LUT Error

At start-up, the function LUT content is checked and updated if needed.
This error is displayed when the LUT can not be reprogrammed; this is usually due to a hardware
problem.
If this message is displayed, the user must inform the service team.

5.5.1 6 Error 1 5: CFM LUT programming time out error

This error is displayed when one of the LUT located on COL_DOP board can not be repro-
grammed, usually due to a hardware problem.
If this message is displayed, the user must inform the service team

5.5.1 7 Error 1 6: Flashcard removed while printing

The following error is displayed if the flashcard is removed while the SIGMA is printing images on
a printer.
Error 16: Flashcard removed while printing

The flashcard has been removed while printing

Print process cancelled.

OK

5.5.1 8 Error 1 7: Internal communication - Fatal error

This internal communication error is similar to the Error 11, but it happens when the host does
not receive message acknowledgement from the processor located on the SUBSI board. In this
case, the “internal communication” error message is displayed. To acknowledge this message
the user presses on any key and a message informs the user that the system will be powered off.
This error can happen when the SUBSI processor has been reset due to software or hardware
problems. If this problem persists, the user should call the service team.
To help the service team to find the cause of this problem, the user must press on the <H> key
(when dialogue is displayed), and printout the current displayed screen. This screen contains
information concerning the last sent messages..

15.10.01 TROUBLESHOOTING 5-21

 This page is intentionally left blank

5-22 SIGMA 110/SIGMA 330 15.10.01

 6. OPTIONS AND ACCESSORIES

10.12.01 OPTIONS AND ACCESSORIES 6-1

6-2 SIGMA 110/SIGMA 330 10.12.01
6.1 Options

SIGMA 110 Options:

450 847 Cine Mode Option
483 281 ECG Option (including set of clamp electrodes)
483 311 Spectral Doppler Option
472 204 Bolero Cart Option
483 184 IR Remote Control Unit Option - ENG
483 176 IR Remote Control Unit Option - FRE
483 168 IR Remote Control Unit Option - GER
483 141 IR Remote Control Unit Option - ITA
483 133 IR Remote Control Unit Option - SPA
483 125 IR Remote Control Unit Option - CYR
481 068 Footswitch
482 765 Ext. Switch box for Master
485 926 Ext. Switch box for Bolero Cart
486 523B EasyPrint™ Black & White
488 852 USB-Link™ option
487 260 VHS option
486531EN/486531GE/486531FR/486531SP SonoWin Lite™ (English/German/French/Spanish version)
488798EN/488798GE/488798FR/488798SP SonoWin Basic™ (English/German/French/Spanish version)
486 345 Flat LCD 15" screen repetition monitor + Holder Kit

Table 6-1 : SIGMA 110 Options

SIGMA 330 Options:

480 908 Colour Flow Mapping Option
483 281 ECG Option (including set of clamp electrodes)
481 068 Footswitch
482 765 Ext. Switch box for Master
485 926 Ext. Switch box for Bolero Cart
486 523 EasyPrint™ Color
488 852 USB-Link™ option
487 260 VHS option
486728EN/486728GE/486728FR/486728IT 3D-FetalView™ (English/German/French/Italian version)
486191EN/486191GE/486191FR/486191IT 3D-VascularView™ (English/German/French/Italian version)
486531EN/486531GE/486531FR/486531SP SonoWin Lite™ (English/German/French/Spanish version)
488798EN/488798GE/488798FR/488798SP SonoWin Basic™ (English/German/French/Spanish version)
486 345 Flat LCD 15" screen repetition monitor + Holder Kit

Table 6-2: SIGMA 330 Options

10.12.01 OPTIONS AND ACCESSORIES 6-3

6.2 List of Probes
Reference No. Probe Type
Convex Linear Probes
471 933 3.5 MHz CV
484 385 3.5 MHz MC
485 497 6.5 MHz MC
Linear Probes
484 474 5.0 MHz LV
474 460 7.5 MHz LV
483 656 7.5MHz LVS
Endocavitarian Probes
469 017 6.5 MHz EV
469 025 6.5 MHz MR
479 101 6.5 MHz VMC
Mechanical Sector Probes
469 041 3.5 MHz GP
469 068 5.0 MHz GP
469 076 7.5 MHz GP
469 033 14 MHz PV
Doppler Pencil Probes
478 733 2.0 MHz PEN
468 517 4.0 MHz PEN
468525 8.0 MHz PEN
468 509 2.0 MHz TCD

Table 6-3: List of Probes

6-4 SIGMA 110/SIGMA 330 10.12.01

6.3 Accessories
Reference No. Designation
100 250 250 ml bottle of ultrasound gel
469 122 Alkaline Battery 1.5 V for Remote control
477 729 Memory card (PCMCIA - SRAM 4 M)
480 266 Memory card (PCMCIA - SRAM 8 M)
485 055 Memory card (Flash 4 M) for backing up
481 068 FREEZE/PRINT Footswitch
503 126 Fuse 5 X 20 mm, T 8 A
528 129 Fuse 5 X 20 mm, T 6.3 A
717 150 Fuse 5 X 20 mm, T 4 A
524 204 Fuse 5 X 20 mm, T 2 A
411 353 Power cable EURO/D CEE 22
487 848 Power cable North American Hospital Grade
412 139 Power cable CEE22M/CEE22F (for integrated peripherals)
488 364 Power cable CEE22M/French female (for peripherals)
481 033 Remote control cable for Video Printer
862 169 Coaxial cable (75 Ohm, BNC/BNC, L = 2m)
486 434 VCR adapter for SVHS
481 076 Cable for S-VHS VCR
487 252 Cable for VHS VCR
485 659 Single S-VHS cable for color printer
479 764 Cable for Sony colour monitor or colour video printer
479 772 Mitsubishi colour monitor cable
485 861 CABEL colour monitor cable
479 802 Patient cable for ECG
430 706 Cable for equalization potential
487 163 USB Cable
485 519 Matrox/Orion Video Cable
487 155 VGA Video Cable
487 309 Keyboard Sticker "CTRL-ALT-ALTGR"
487 368 Keyboard Sticker "CAPS-DEL"
490 199 Cable D-Sub 25 M/F L = 1.5 m
489 859 Printer port isolator
488 542 S-Video isolator
490 024 S-Video distributor
488 550 BNC Video Isolation Amplifier
489 689 Adaptor S-VHS F/F mini DIN
487 732 Medical Grade isolating transformer (max. 750 VA)
DOC31001EN Operator Manual SIGMA 110/330 - English
DOC31002EN Service Manual SIGMA 110/330 - English
DOC31004EN Operator Manual 3D-Vascular/Fetal View - English

Table 6-4: Accessories

10.12.01 OPTIONS AND ACCESSORIES 6-5

 Reference No. Designation
462 489 Medical Ultrasound Safety Guide
870072 Printer cable Par. Bi-direct Subd 25M - Centronic 36M L= 1.8 m
488 216 RJ-45 Network isolator
482 951 Handle (for SIGMA 110 and SIGMA 330 Master)
462 519 Wall shelf
489 336 External FireWire 1.3 GB Magneto-Optical Disk Drive
489 506 Re-writable 1.3 GB Magneto-Optical Disk
488 763 Kit of 10 air filters
NA HEWLETT PACKARD Deskjet 990Cxi (local purchasing)
NA B & W Video Printer MITSUBISHI P91E (local purchasing)
NA B & W Video Printer SONY UP890MD (local purchasing)
NA Colour Video Printer MITSUBISHI CP700E (local purchasing)
NA B & W VHS VCR (local purchasing)
NA Additional B & W Monitor (local purchasing)

Table 6-4: Accessories

6-6 SIGMA 110/SIGMA 330 10.12.01

 7. APPENDICES

15.10.01 APPENDICES 7-1

7-2 SIGMA 110/SIGMA 330 15.10.01
Appendix A: Overview

A.1 Entering the Biometry

To enter the Biometry, press <REPORT> key. The image is automatically frozen if needed, and
according to the current medical application (Radio, ObGyn,...) and current mode (2D, TM,...), a
specific biometry screen is displayed.

xxx study abc study zzz study

---- 0.00 ---- 0.00 ---- 0.00
--- 0.00 ------ 0
------- 0.00
Freeze --- 0
def study yyx study
---- 0.00
Report ---
------
0
0
----
------
0.00
0 --- 0.00
------- 0.00
xyy study fgt study --- 0
--- 0
---- 0.00 ---- 0.00 ------ 0

Report ...... ...... ...... ...... ......

A.2 Exiting the Biometry

There are several means to exit the biometry:
• using the <REPORT> key, the user returns to the frozen image,

xxx study abc study zzz study

---- 0.00 ---- 0.00 ---- 0.00
--- 0.00 ------ 0
------- 0.00 def study yyx study
--- 0
---
------
0
0
----
------
0.00
0
----
---
0.00
0.00 Report
------- 0.00
xyy study fgt study --- 0
--- 0
---- 0.00 ---- 0.00 ------ 0

...... ...... ...... ...... ......

FROZEN

• using the <ESCAPE> key is the same as using the <REPORT> key
• using the <FREEZE> key, the user returns to a live image
• using the <MEASUREMENT> key, the user returns to a frozen image with the measure-
ment menu active.
• using the <ANNOTATION> key, the user returns to a frozen image with the annotation
menu active.
• using the <PROBE> key, the user returns to a frozen image with the probe menu active.
• using the <MAGNIFY> key, the user returns to a frozen magnified image when the cur-
rent mode is the single 2D.

A.3 Make a Measurement from Report

The represents the cursor used to select an object (measurement field or information field).
This arrow can be moved with the trackball. When this arrow is over a valid object, the selected
field is displayed in inverted video. To enter the selection, the user presses on the <ENTER> or
<SET> key. When the selected field is a main field, the sigma switches to the frozen ultrasound

15.10.01 APPENDICES 7-3

image and the measurement associated with the selection is automatically started. The user has
now the possibility to:
• finish the measurement: the sigma switches then to the report screen and automatically
updates the selected field and if needed, updates results fields and computed fields.
• abort the measurement and return to the report screen: the user aborts the measure-
ment by pressing on the <ESCAPE> key.
• abort the measurement and exit the biometry: the user presses on the <FREEZE> key.
The sigma returns then to the live mode.

A.4 Importing Measurements in Report

After having done a measurement, the user wants to insert it in the report; he selects the suitable
report sheet and moves the trackball cursor on the fields of interest. When a relevant field is
pointed, it highlights to indicate the insertion is possible. The user then presses on the CURSOR
SET key to insert the last measurement. All the related results and computed fields are automat-
ically updated if all data are available.
Note: to activate the import mode, the measurement menu must be displayed before entering
the report.

7-4 SIGMA 110/SIGMA 330 15.10.01

Appendix B: Report Menu
The meaning of the icons present in the different report menus are explained hereunder:

Select a new medical application

Go to next page

Go to previous page

Reset the selected field to zero

View the selected ObGyn curve

View printable report preview

Start a new study;

erase all the biometry fields

Display setup screen for ObGyn

Validate the user’s choice on the displayed sh

Exit current sheet

Return to the previously displayed sheet

Print the report on the printer

Save the report on the flashcard

By pressing the icon, the user changes the medical application. This modification
concerns only the biometry study (the medical application of the probe does not change). After
this operation a new biometry page (according to the current medical application) is proposed.

The icon is only displayed when the current medical application study has more
than one page. Pressing on this key displays the next page of the study.
Note : the report sheets are organized as a circular list :

first page + = last page

15.10.01 APPENDICES 7-5

last page + = first page

The icon is used in the print preview menu. Pressing on this key displays the previ-
ous page of the study. When the first page or the last page is displayed, the following rule is
applied:
first page + = last page

last page + = first page

The icon is used to delete a field. Pressing this key will delete the selected field
(video inverted field)

By selecting the icon, the user displays the printable report of his measurement.

The icon is used to print the report on an external printer.

The icon display the currently selected ob/gyn curve (i.e. the curve corresponding to
the selected field in the master ob/gyn page or the selected curve from the Ob/gyn setup page).

The icon is used to change the working set of ob/gyn growth curves.

Before starting a new study with a new patient, the user must press on the icon.
Doing so, all the fields will be reset to zero.

The is used to validate user’s choice in setup and user setup pages. Doing so, all
the user’s changes are recorded in NoVRAM. If the user doesn’t need to save his changes, he
exists the displayed sheet using the <ESCAPE> key on keyboard.

The is used to exit the print preview and return to the previous screen.

7-6 SIGMA 110/SIGMA 330 15.10.01

Appendix C: Patient Information

C.1 First Page

C.1.1 Description
The user enters this page when he presses on the <PATID> key while an ultrasound image is
displayed.
14/02/01 08:30:31
______ LABORATORY INFORMATION _______________________ Page 1 ______

LAB. : •••••••••••••••••••••••••••••••••••••••••••••••••••••
PHYSICIAN : •••••••••••••••••••••••••••••••••••••••••••••••••••••
OPERATOR : •••••••••••••••••••••••••••••••••••••••••••••••••••••

______ PATIENT INFORMATION ___________________________________

EXAM.N : ••••• FOLDER N : ••••• TAPE : •••••

NAME : •••••••••••••••••••••••••••••••••••••••••••••••••••••
ADDRESS : •••••••••••••••••••••••••••••••••••••••••••••••••••••
•••••••••••••••••••••••••••••••••••••••••••••••••••••
PHONE : •••••••••

HEIGHT : ... cm WEIGHT : ... kg BSA : m2

BIRTHDATE : ../../.... SEX : ... HR : ... b/mn
______ OB/GYN STUDIES ___________________________________________

LMP : ../../.... NWA : wk EBD:

Note: the LMP, NWA and EBD information are always displayed on start page.

The icon is used to reset the whole study.

For more details on report menu, see Appendix B, “Report Menu”, on page 7-5.

C.1.1.1 Laboratory Information :

LAB. : Laboratory
PHYSICIAN : Physician name
OPERATOR : Operator name

C.1.1.2 Patient Information :

EXAM. N : Exam Number

FOLDER N : Folder Number

15.10.01 APPENDICES 7-7

 TAPE : Tape
NAME : Patient Name
ADDRESS : Patient Address
PHONE : Phone Number
HEIGHT : Height in cm
WEIGHT : Weight in kg
BSA : Body Surface Area in m2
BIRTHDATE : Patient birth date
SEX : Patient sex
HR : Patient Heart Rate in beats per minute.
This field is unused in computations, it is only an information field.

The three following fields are useful for obstetrician:

LMP : Last Menstrual Period
NWA : Number of Weeks of Amenorrhea
EBD : Estimated Birth Date

C.1.2 Equation
• Body Surface Area in m2 (BSA) from Dubois and Dubois
4 0,425 0,725
BSA D 71,84 ⋅ 10 ⋅W ⋅H

• W: weight in kg
H : height in cm

7-8 SIGMA 110/SIGMA 330 15.10.01

C.2 Second Page

If the user presses on the icon of first patient information page, the following sheet
is displayed. If the user presses the same icon from the second patient information page, the first
page is displayed again. For more details on report menu, see Appendix B, “Report Menu”, on
page 7-5.

14/02/01 08:30:31

______ PATIENT INFORMATION _________________________ Page 2 ______

REF.PHYS. :
•••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••
EXAMINATION REASONS :
•••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••
•••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••
•••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••

TREATMENT :
•••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••
•••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••

COMMENTS :
•••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••
•••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••
•••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••
•••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••
•••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••

REF. PHYS : Referring physician

EXAMINATION REASONS
TREATMENT
COMMENTS

15.10.01 APPENDICES 7-9

 This page is intentionally left blank

7-10 SIGMA 110/SIGMA 330 15.10.01

Appendix D: Cardiology Study
The cardiology report sheets are ordered according to the studied function (left ventricle, mitral
valve, aortic valve, right ventricle ...). The following drawing locates the main studied functions:

AORTA
PULMONIC PULMONARY ARTERY
VALVE

AORTIC VALVE

MITRAL VALVE

TRICUSPID
VALVE LEFT VENTRICLE

Hereunder, the functions and measurements available in the cardio study sheet are described.

15.10.01 APPENDICES 7-11

D.1 Left Ventricle Study
D.1.1 Description
This sheet owns three parts as described here under:
14/01/98 08:30:31
LAB. : •••••••••••••••••••••••••••••••••••••••••••••••••••••
OPER. : •••••••••••••••••••••••••••••••••••••••••••••••••••••
NAME : •••••••••••••••••••••••••••••••••••••••••••••••••••••
EXAM.N:••••• SEX:•••H:...cm W:...kg AGE: y BSA: m2 HR:...b/mn
__ CARDIOLOGY STUDIES : LEFT VENTRICLE ___________________________________
LEFT VENTRICLE (TM) ->CO[l/mn] LV SIMPSON (2D)
RVDd[cm] ____ ->CI[l/mn/m2] SAA1d[cm2] ____
IVSd[cm] ____ ->H/R SAA2d[cm2] ____
*LVDd[cm] LALd[cm] ____
*PLVWd[cm] LEFT VENTRICLE (2D) SAA1s[cm2] ____
*IVSs[cm] LALd[cm] ____ SAA2s[cm2] ____
*LVDs[cm] LAAd[cm2] ____ LALs[cm] ____
*PLVWs[cm] LALs[cm] ____ ->VOLd[cm3]
LVET[s] ____ LAAs[cm2] ____ ->VOLs[cm3]
->VOLd[cm3] ->VOLd[cm3] ->EF[%]
->VOLs[cm3] ->VOLs[cm3] ->SV[ml]
->SF[%] ->EF[%] ->SI[ml/m2]
->LVM[g] ->SV[ml] ->CO[l/mn]
->LVMI[g/m2] ->SI[ml/m2] ->CI[l/mn/m2]
->VCF[circ/s] ->CO[l/mn]
->EF[%] ->CI[l/mn/m2] HEART RATE
->SV[ml] HR[b/mn] ____
->SI[ml/m2]

D.1.1.1 Left Ventricle Study

a) 2D measurements

LALd : Long Axis Length at diastole in cm

LAAd : Long Axis Area at diastole in cm2
LALs : Long Axis Length at systole in cm
LAAs : Long Axis Area at systole in cm2
->VOLd : Diastolic Volume in cm3
->VOLs : Systolic Volume in cm3
->EF : Ejection Fraction in percent
->SV : Stroke Volume in millilitres
->SI : Stroke Index in millilitres
->CO : Cardiac Output in litres per minute
->CI : Cardiac Index in litres per minute per square meters

b) TM measurements

RVDd : Right Ventricle Diameter at diastole in cm

IVSd : Inter Ventricular Septal Thickness at diastole in cm

7-12 SIGMA 110/SIGMA 330 15.10.01

 *LVDd : Left Ventricle Diameter at diastole in cm
*PLVWd : Posterior Left Ventricular Wall at diastole in cm
*IVSs : Inter Ventricular Septal Thickness at systole in cm
*LVDs : Left Ventricle Diameter at systole in cm
*PLVWs : Posterior Left Ventricular Wall at systole in cm
LVET : Left Ventricle Ejection Time in second
->VOLd : Diastolic Volume (Teichholz formula) in cm3
->VOLs : Systolic Volume (Teichholz formula) in cm3
->SF : Shortening Fraction in percent
->LVM : Left Ventricle Mass in grams
->LVMI : Left Ventricle Mass Index in grams per square meters
->VCF : Velocity of Circumferential Fibre Shortening in circumference per second
->EF : Ejection Fraction in percent
->SV : Stroke Volume in millilitres
->SI : Stroke Volume Index in millilitres per square meters
->CO : Cardiac Output in litres per minute
->CI : Cardiac Output Index in litres per minute per square meter
->H/R : Ratio Left Ventricular Wall (diastole) on Left Ventricle Radius (diastole)

D.1.1.2 Left Ventricle Study (Simpson)

SAA1d : Short Axis Area 1 at Diastole in cm2

SAA2d : Short Axis Area 2 at Diastole in cm2
LALd : Long Axis Length at Diastole in cm
SAA1s : Short Axis Area 1 at Systole in cm2
SAA2s : Short Axis Area 2 at Systole in cm2
LALs : Long Axis Length at Systole in cm
->VOLd : Diastolic Volume in cm3
->VOLs : Systolic Volume in cm3
->EF : Ejection Fraction in percent
->CO : Cardiac Output in litres per minute
->CI : Cardiac Index in litres per minute per square meters
->SV : Stroke Volume in millilitres
->SI : Stroke Index in millilitres

D.1.1.3 Heart Rate (TM and SP Measurement)

HR : Heart rate in beats per minutes measured on Left Ventricle. This field is used
for the computation of the left ventricle study sheet

D.1.2 Equations

D.1.2.1 General Information

• Body Surface Area in m2 (BSA) from Dubois and DuboisW: weight in kg

4 0,425 0,725
BSA D 71,84 ⋅ 10 ⋅W ⋅H

W : weight in kg
H : height in cm

15.10.01 APPENDICES 7-13

D.1.2.2 Left Ventricle Study

a) 2D study:

• End Diastolic Volume in cm3 (VOLd))

2
8 ⋅ LAAd
VOLd D ------------------------------
3 ⋅ π ⋅ LALd

LAAd : Long Axis Area at diastole in cm2

LALd : Long Axis Length at diastole in cm

• End Systolic Volume in cm3 (VOLs)

2
8 ⋅ LAAs
VOLs D ------------------------------
3 ⋅ π ⋅ LALs

LAAs : Long Axis Area at systole in cm2

LALs : Long Axis Length at systole in cm

• Ejection Fraction in percent (EF)

VOLd VOLs
EF D -------------------------------------- ⋅ 100
VOLd

VOLd : End diastolic Volume in cm3

VOLs : End systolic Volume in cm3

• Stroke Volume in millilitres (SV)

SV D VOLd VOLs

VOLd : End diastolic Volume in cm3

VOLs : End systolic Volume in cm3

• Stroke Volume Index in square meters (SI)

SV
SI D ------------
BSA

SV : Stroke Volume in millilitres

BSA : Body Surface Area in m2

• Cardiac Output in litres per minute (CO)

SV ⋅ HR
CO D ---------------------
1000

SV : Stroke Volume in millilitres

HR : Heart Rate in beats per minute

7-14 SIGMA 110/SIGMA 330 15.10.01

 • Cardiac Output Index in litres per minute per square meters (CI)
CO
CI D ------------
BSA

CO : Cardiac Output in litres per minute

BSA : Body Surface Area in m2

b) TM study

• End Diastolic Volume in cm3 with Teichholz (VOLd)

3
7 ⋅ LVDd
VOLd D -----------------------------
2,4 0 LVDd

LVDd : Left Ventricle Diameter (diastole) in cm

• End Systolic Volume in cm3 with Teichholz (VOLs)

3
7 ⋅ LVDs
VOLs D ----------------------------
-
2,4 0 LVDs

LVDs : Left Ventricle Diameter (systole) in cm

• Shortening fraction in percentage (SF)

LVDd LVDs
SF D ------------------------------------- ⋅ 100
LVDd

LVDd : Left Ventricle Diameter (diastole) in cm

LVDs : Left Ventricle Diameter (systole) in cm

• Left Ventricle Mass in grams (LVM)

3 3
LVM D 1,04 ⋅ ( IVSd 0 LVDd 0 PLVW ) LVDd 13,6

IVSd : Inter Ventricular Septal thickness (diastole) in cm

LVDd : Left Ventricle Diameter (diastole) in cm
PLVWd : Left Ventricular posterior wall (diastole) in cm

• Left Ventricle Mass Index in grams per square meters (LVMI)

LVM
LVMI D -------------
BSA

LVM : Myocardial Mass in grams

BSA : Body Surface Area in m2

15.10.01 APPENDICES 7-15

 • Left Ventricle circumferential in circumference per second (VCF)

VCF D LVDd LVDs

-------------------------------------
LVDd ⋅ LVET

LVDd : Left Ventricle Diameter (diastole) in cm

LVDs : Left Ventricle Diameter (systole) in cm
LVET : Left Ventricle Ejection Time in second

• Ejection Fraction in percent (EF)

VOLd VOLs
EF D -------------------------------------- ⋅ 100
VOLd

VOLd : End diastolic Volume in cm3 (Teichholz)

VOLs : End systolic Volume in cm3 (Teichholz)

• Stroke Volume in millilitres (SV)

SV D VOLDs VOLSs

VOLd : End diastolic Volume in cm3 (Teichholz)

VOLs : End systolic Volume in cm3 (Teichholz)

• Stroke Volume Index in millilitres per square meters (SI)

SV -
SI D -----------
BSA

SV : Stroke Volume in millilitres

BSA : Body Surface Area in m2

• Cardiac Output in litres per minute (CO)

CO D SV ⋅ HR
---------------------
1000

SV : Stroke Volume in cm2

HR : Heart Rate in beats per minute

• Cardiac Output Index in litres per minute per square meters (CI)
CO
CI D -----------
-
BSA

CO : Cardiac Output in litres per minute

BSA : Body Surface Area in m2

• Ratio Left Ventricular Wall at diastole on Left Ventricle Radius at diastole (H/R)

IVSDd 0 PLVWd
H ⁄ R D ----------------------------------------------
LVDd

7-16 SIGMA 110/SIGMA 330 15.10.01

 IVSDd :Inter Ventricular Septal Thickness at diastole
PLVWd :Posterior Left Ventricular Wall at diastole
LVDd :Left Ventricle Diameter at diastole

D.1.2.3 Left Ventricle Study (Simpson)

• End Diastolic Volume in cm3 (VOLd)

VOLd D  SAA1d 0 2 ⋅ SAA2d- ⋅  LALd

-------------------------- ---------------
 3   2 

SAA1d : Short Axis Area 1 at diastole in cm2

SAA2d : Short Axis Area 2 at diastole in cm2
LALd : Long Axis Length at diastole in cm

• End Systolic Volume in cm3 (VOLs)

VOLs D  SAA1s 0 2 ⋅ SAA2s LALs

 -------------------------- ⋅  --------------
3 2

SAA1s : Short Axis Area 1 at systole in cm2

SAA2s : Short Axis Area 2 at systole in cm2
LALs : Long Axis Length at systole in cm

• Ejection Fraction in percent (EF)

VOLd VOLs
EF D -------------------------------------- ⋅ 100
VOLd

VOLd : End diastolic Volume in cm3

VOLs : End systolic Volume in cm3

• Cardiac Output in litres per minute (CO)

SV ⋅ HR
CO D ---------------------
1000

SV : Stroke Volume in millilitres

HR : Heart Rate in beats per minute

• Cardiac Output Index in litres per minute per square meters (CI)
CO-
CI D -----------
BSA

CO : Cardiac Output in litres per minute

BSA : Body Surface Area in m2

• Stroke Volume in millilitres (SV)

SV D VOLd VOLs

VOLd : End diastolic Volume in cm3

VOLs : End systolic Volume in cm3

15.10.01 APPENDICES 7-17

 • Stroke Volume Index in millilitres per square meters (SI)
SV
SI D -----------
-
BSA

SV : Stroke Volume in millilitres

BSA : Body Surface Area in m2

D.2 Mitral Valve Study

D.2.1 Description
14/01/98 08:30:31
LAB. : •••••••••••••••••••••••••••••••••••••••••••••••••••••
OPER. : •••••••••••••••••••••••••••••••••••••••••••••••••••••
NAME : •••••••••••••••••••••••••••••••••••••••••••••••••••••
EXAM.N:••••• SEX:•••H:...cm W:...kg AGE: y BSA: m2 HR:...b/mn
__ CARDIOLOGY STUDIES : MITRAL VALVE _____________________________________

MV ANNULUS (2D) MITRAL VALVE (SP) MITRAL VALVE EOA

MVD[cm] ____ VTI[cm] ____ *CONTINUITY EQUATION
MVA[cm2] ____ *PkV[m/s] SAD[cm] ____
*PkG[mmHg] ->SAA[cm2]
*MnG[mmHg] VTIsa[cm]____
MITRAL VALVE (TM) PkVE[m/s] ____ VTImv[cm]____
EFsl[cm/s] ____ PkVA[m/s] ____ ->EOA[cm2]
ESd[cm] ____ IVRT[s] ____
->E/A *PHT
HEART RATE ->SV[ml]
PHT[ms]____
HR[b/mn] ____ ->SI[ml/m2]
->CO[l/mn] *PkVE[m/s]
->EOA [cm2]
->CI[l/mn/m2]

D.2.2 2D measurements
MVD : Mitral Valve Diameter in cm
MVA : Mitral Valve Area in cm2

a) TM measurements

EFsl : Slope between E- and F-waves in cm/s

ESd : Distance from E-wave to septum in cm

b) SP measurements

VTI : Velocity Time Integral in cm

*PkV : (VTI) Peak Velocity in m/s
*PkG : (VTI) Peak Gradient in mmHg

7-18 SIGMA 110/SIGMA 330 15.10.01

 *MnG : (VTI) Mean Gradient in mmHg
PkVE : Peak Velocity for the E-wave in m/s
PkVA : Peak Velocity for the A-wave in m/s
IVRT : IsoVolumetric Relaxation Time in second
->E/A : Ratio Peak Velocity E-wave on Peak Velocity A-wave (PkVE/PkVA)
->SV : Stroke Volume in millilitres
->SI : Stroke Volume Index in millilitres per square meters
->CO : Cardiac Output in litres per minute
->CI : Cardiac Output Index in litres per minute per square meters

c) Heart rate (TM or SP measurement)

HR : Patient heart rate in beats per minutes on mitral valve.

This field is used for the computation of the mitral valve study sheet

d) Mitral Valve Effective Opening Area

• Continuity Equation
SAD : Sub Aortic Diameter in cm
->SAA : Area in cm2 computed from DiamAOV
VTIaov : Sub Aortic Velocity Time Integral in cm
VTImv : Velocity Time Integral at Mitral Valve in cm
->EOA : Mitral Valve EOA in cm2 computed from VTIaov and VTImiv

• Pressure Half Time

PHT : Pressure Half Time in millisecond
*PkVE : Peak Velocity for E-wave in m/s
->EOA : Valve Area in cm2 computed from Pressure Half Time

D.2.3 Equations

a) SP study

• Velocity Time Integral (VTI) in cm

VTI= ∑ Vi ⋅ ∆t
Df ⋅ C
V D -----------------------------
2 ⋅ f 0 ⋅ cos α

Vi : Velocity (in m/s) during each Dt (in s) of measured spectral area

Df : Doppler frequency in Herz
C : Sound velocity (1540 m/s)
f0 : Ultrasound frequency in Herz
a : Angle between the ultrasound beam and blood velocity

15.10.01 APPENDICES 7-19

 • Pressure Time Integral in seconds per mmHg (PTI)

PTI= ∑ Pi ⋅ ∆t
2
P D 4v

Pi : Pressure (in mmHg) during each Dt (in s) of the velocity spectrum

Computed from simplified Bernouilli equation.
v : Velocity in m/s

• Mean Gradient in mmHg (MnG)

PTI
MnG D --------------
Time

PTI : Pressure Time Integral

Time : Duration flow in seconds

• Pressure Half Time in millisecond (PHT)

PV ⋅ ( 1 2)
PHT D ---------------------------------
S

PV : Peak Velocity in metres per millisecond

S : Slope in metres per square seconds

• Mitral Valve Area in cm2 (EOA) computed from PHT

220
EOA D ------------
PHT

PHT : Pressure Half Time in milliseconds

• Cardiac Output in litres per minute (CO)

CO D SV ⋅ HR
---------------------
1000

SV : Stroke Volume in millilitres

HR : Heart Rate in beats per minute

• Cardiac Output Index in litres per minute per square meters (CI)
CO
CI D -----------
-
BSA

CO : Cardiac Output in litres per minute

BSA : Body Surface Area in square meters

7-20 SIGMA 110/SIGMA 330 15.10.01

 • Stroke Volume in millilitres(SV)

SV D MVA ⋅ VTI
2
π ⋅ MVD
MVA D -------------------------
4

VTI : Velocity Time Integral in cm

MVD : Mitral Valve Diameter in cm

• Stroke Index Volume in millilitres per square metres (SI)

SV
SI D ------------
BSA

SV : Stroke Volume in millilitres

BSA : Body Surface Area in square meters

b) Continuity equation

• Area in cm2 computed from SAD (SAA)

2
SAA D π ⋅ SAD -
----------------------
4

SAD : Sub Aortic Diameter in cm

• Mitral Valve EOA in cm2 computed from velocities time integral (EAO)

EAO D SAA ⋅ VTIsa-

--------------------------------
VTImv

VTIsa : Sub Aortic Velocity Time Integral in cm

VTImv : Mitral Valve Velocity Time Integral in cm

15.10.01 APPENDICES 7-21

D.3 Aortic Valve Study
D.3.1 Description
14/01/98 08:30:31
LAB. : •••••••••••••••••••••••••••••••••••••••••••••••••••••
OPER. : •••••••••••••••••••••••••••••••••••••••••••••••••••••
NAME : •••••••••••••••••••••••••••••••••••••••••••••••••••••
EXAM.N:••••• SEX:•••H:...cm W:...kg AGE: y BSA: m2 HR:... b/mn
__ CARDIOLOGY STUDIES : AORTIC VALVE ___________________________________
AORTIC VALVE (2D) AORTIC VALVE (TM) LVOT (SP)
AVD[cm] ____ AoD[cm] ____ VTI[cm] ____
AVA[cm2] ____ LAD[cm] ____ *PkV[m/s]
AORTIC VALVE (SP) AVO[cm] ____ *PkG[mmHg]
VTI[cm] ____ LVET[s] ____ *MnG[mmHg]
*PkV[m/s] LVPEP[s] ____ ->SV[ml]
*PkG[mmHg] ->LAD/AoD ->SI[ml/m2]
*MnG[mmHg] ->LVPEP/LVET ->CO[l/mn]
PHT[ms] ____ ->CI[l/mn/m2]
LVPEP[s] ____ HEART RATE AORTIC VALVE EOA
->SV[ml] HR[b/mn]____ LVOTD[cm]____
->SI[ml/m2] *LVOTA[cm2]
->CO[l/mn] LVOT (2D) VTIlvot[cm]____
->CI[l/mn/m2] LVOTD[cm] ____ VTIao[cm]____
DESCENDING AORTA(SP) LVOTA[cm2] ____ ->EOA[cm2]
VTIs[cm] ____ Vlvot[m/s]____
VTId[cm] ____ Vao[m/s]____
->VTId/VTIs ->EOA[cm2]

D.3.2 Aortic Valve

a) 2D study

AVA : Aortic Valve Area in cm2

AVD : Aortic Valve Diameter in cm

b) SP study

VTI : Velocity Time Integral in cm

*PkV : (VTI) Peak Velocity in m/s
*PkG : (VTI) Peak Gradient in mmHg
*MnG : (VTI) Mean Gradient in mmHg
PHT : Pressure Half Time in millisecond
LVPEP : Left Ventricle Pre Ejection Period in second
->SV : Stroke Volume in millilitres
->SI : Stroke Volume Index in millilitres per square meters
->CO : Cardiac Output in litres per minute
->CI : Cardiac Output Index in litres per minute per square meters

7-22 SIGMA 110/SIGMA 330 15.10.01

 c) TM study

AoD : End diastolic Aortic Root diameter in cm

LAD : Left Atrial end systolic diameter in cm
AVO : Aortic Valve Opening in cm
LVET : Left Ventricle Ejection Time in second
LVPEP : Left Ventricle Pre-Ejection Period in second
->LAD/AoD : Ratio Left Atrial, Aortic Root Diameter
->LVPEP/LVET: Ratio Pre Ejection Period, Ejection Time

d) Effective Opening Area Aortic Valve

LVOTD : Left Ventricle Output Trunk Diameter in cm

*LVOTA : Area in cm2 computed from Divot
Vlvot : Velocity at Left Ventricle Output Trunk in meters per second
Vao : Velocity at Aortic Valve in meters per second
VTIlvot : Velocity Time Integral at Left Ventricle Output Trunk in cm
VTI : Velocity Time Integral at Aortic Valve in cm
->EOA : Effective Opening Area of the Aortic Valve in cm2. This area can be com-
puted from VTIlvot and VTIao, or from Vao and Vlvot.

D.3.2.1 Left Ventricle Output Trunk

a) 2D study

LVOTD : LVOT Diameter in cm

LVOTA : LVOT Area in cm2

b) SP study

VTI : Velocity Time Integral in cm

*PkV : Peak Velocity in m/s
*PkG : Peak Gradient in mmHg
*MnG : Mean Gradient in mmHg
->SV : Stroke Volume in millilitres
->SI : Stroke Volume Index in millilitres per square meters
->CO : Cardiac Output in litres per minute
->CI : Cardiac Output Index in litres per minute per square meters

D.3.2.2 Descending Aorta (SP Measurement)

VTIs : Velocity Time Integral at Systole in cm

VTId : Velocity Time Integral at Diastole in cm
VTId/VTIs : Ratio VTI Diastole, VTI Systole

D.3.2.3 Heart Rate (TM or SP Measurement)

HR : Heart Rate in beat per minute on aortic valve

This field is used for the computation of the aortic valve study sheet

15.10.01 APPENDICES 7-23

D.3.3 Equations

a) SP study

• Velocity Time Integral (VTI) in cm

VTI= ∑ Vi ⋅ ∆t
D ⋅C
f
V D ----------------------------
-
2 ⋅ f 0 ⋅ cos α

Vi : Velocity (in m/s) during each Dt (in s) of measured spectral area

Df : Doppler frequency in Herz
C : Sound velocity (1540 m/s)
f0 : Ultrasound frequency in Herz
a : Angle between the ultrasound beam and blood velocity

• Pressure Time Integral in seconds per mmHg (PTI)

PTI= ∑ Pi ⋅ ∆t
2
P D 4v

Pi : Pressure (in mmHg) during each Dt (in s) of the velocity spectrum

Computed from simplified Bernouilli equation
v : Velocity in m/s

• Mean Gradient in mmHg (MnG)

PTI
MnG D --------------
Time

PTI : Pressure Time Integral

Time : Duration flow in seconds

• Pressure Half Time in millisecond (PHT)

PV ⋅ ( 1 0,707 )
PHT D ----------------------------------------
S

PV : Peak Velocity in metres per millisecond

S : Slope in metres per square seconds

• Cardiac Output in litres per minute (CO)

SV ⋅ HR
CO D ---------------------
1000

SV : Stroke Volume in millilitres

HR : Heart Rate in beats per minute

7-24 SIGMA 110/SIGMA 330 15.10.01

 • Cardiac Output Index in litres per minute (CI)
CO
CI D ------------
BSA

CO : Cardiac Output in litres per minute

BSA : Body Surface Area in square meters

• Stroke Volume in millimetres (SV)

SV D area ⋅ VTI
2D
2
area π⋅D
D --------------
2D -
4

VTI : Velocity Time Integral

D : Diameter of vessel in centimetres

• Stroke Index Volume in millilitres per square metres (SI)

SV
SI D -----------
-
BSA

SV : Stroke Volume in millilitres

BSA : Body Surface Area in square meters

b) Continuity equation

• Area in cm2 computed from LVOTD (LVOTA)

2
π ⋅ LVOTD
LVOTA D -------------------------------
4

LVOTD :Left Ventricle Output Trunk Diameter in cm

• Effective Opening Area at Aortic Valve in cm2 computed from velocities (EOA)

LVOTA ⋅ Vlvot
EOA D ----------------------------------------
Vao

Vlvot : Velocity at Left Ventricle Output Trunk in m/s

Vao : Velocity at Aortic Valve in m/s

• EOA at Aortic Valve in cm2 computed from velocities time integral (EOA)

EOA D LVOTA ⋅ VTIlvot-

---------------------------------------------
VTIao

VTIlvot : Velocity Time Integral at Left Ventricle Output Trunk in cm

VTIao : Velocity Time Integral at Aortic Valve in cm

15.10.01 APPENDICES 7-25

D.4 Right Ventricle Study
D.4.1 Description
14/01/98 08:30:31
LAB. : •••••••••••••••••••••••••••••••••••••••••••••••••••••
OPER. : •••••••••••••••••••••••••••••••••••••••••••••••••••••
NAME : •••••••••••••••••••••••••••••••••••••••••••••••••••••
EXAM.N:••••• SEX:•••H:...cm W:...kg AGE: y BSA: m2 HR:... b/mn
__ CARDIOLOGY STUDIES: RIGHT VENTRICLE ____________________________________
PULMONIC VALVE (2D) TRICUSPID VALVE (TM) CONTINUITY EQUATION
PAD[cm] ____ DEsl[cm/s] ____ Diam1[cm] ____
*AREA1[cm2]
PULMONIC VALVE (SP) TRICUSPID VALVE (SP) VTI1[cm] ____
VTI[cm] ____ TRV[m/s] ____ VTI2[cm] ____
*PkV[m/s] ->RVRAGr[mmHg] ->Area2[cm2]
*PkG[mmHg] VEL1[m/s] ____
*MnG[mmHg] VEL2[m/s] ____
RVPEP[s] ____ HEART RATE ->AREA2[cm2]
->SV[ml] HR[b/mn] ____
->SI[ml/m2]
->CO[l/mn]
->CI[l/mn/m2]

D.4.2 Pulmonic Valve

a) 2D measurements

PAD :Pulmonary Artery Diameter in cm

b) SP measurements

VTI : Velocity Time Integral in cm

*PkV : (VTI) Peak Velocity in m/s
*PkG : (VTI) Peak Gradient in mmHg
*MnG : (VTI) Mean Gradient in mmHg
PHT : Pressure Half Time in millisecond
RVPEP : Right Ventricle Pre Ejection Period in second
->SV : Stroke Volume in millilitres
->SI : Stroke Volume Index in millilitres per square meters
->CO : Cardiac Output in litres per minute
->CI : Cardiac Output Index in litres per minute per square meters

D.4.2.1 Tricuspid Valve

a) TM measurements

DEsl : Slope between D- and E-wave in cm/s

7-26 SIGMA 110/SIGMA 330 15.10.01

 b) SP measurements

TRV : Tricuspid Regurgitation Velocity in m/s

->RVRAGr : Right Ventricular Right Atrial Gradient mmHg

D.4.2.2 Continuity Equation (Free Measurement)

a) 2D measurements

Diam : Diameter in cm
->AREA1 : Area 1 in cm2 computed from Diam1

b) SP measurements

VTI1 : Velocity Time Integral 1 in cm

VTI2 : Velocity Time Integral 2 in cm
->AREA2 : Area 2 in cm2 computed from VTI1 and VTI2
Vel1 : Velocity 1 in meters per second
Vel2 : Velocity 2 in meters per second
->AREA2 : Area 2 in cm2 computed from VEL1 and VEL2

D.4.2.3 Heart Rate (SP or TM Measurement)

HR : Heart rate in beats per minutes on right ventricle.

This field is used for the computation of the right ventricle study sheet

D.4.3 Equations

D.4.3.1 Pulmonic Valve

• Velocity Time Integral (VTI) in cm

VTI= ∑ Vi ⋅ ∆t
Df ⋅ C
V D -----------------------------
2 ⋅ f 0 ⋅ cos α

Vi : Velocity (in m/s) during each Dt (in s) of measured spectral area

Df : Doppler frequency in Herz
C : Sound velocity (1540 m/s)
f0 : Ultrasound frequency in Herz
a : Angle between the ultrasound beam and blood velocity

• Pressure Time Integral in seconds per mmHg (PTI)

PTI= ∑ Pi ⋅ ∆t
2
P D 4v

Pi : Pressure (in mmHg) during each Dt (in s) of the velocity spectrum

15.10.01 APPENDICES 7-27

 Computed from simplified Bernouilli equation
v : Velocity in m/s

• Mean Gradient in mmHg (MnG)

PTI
MnG D -------------
-
Time

PTI : Pressure Time Integral

Time : Duration flow in seconds

• Pressure Half Time in millisecond (PHT)

PV ⋅ ( 1 0,707 )
PHT D ---------------------------------------
-
S

PV : Peak Velocity in metres per millisecond

S : Slope in metres per square seconds

• Cardiac Output in litres per minute (CO)

SV ⋅ HR
CO D ---------------------
1000

SV : Stroke Volume in millilitres

HR : Heart Rate in beats per minute

• Cardiac Output Index in litres per minute (CI)

CO
CI D -----------
-
BSA

CO : Cardiac Output in litres per minute

BSA : Body Surface Area in square meters

• Stroke Volume in millimetres (SV)

SV D area 2D ⋅ VTI
2
π⋅D-
area 2D D --------------
4

VTI : Velocity Time Integral

D : Diameter of vessel in centimetres

• Stroke Index Volume in millilitres per square metres (SI)

SV
SI D ------------
BSA

SV : Stroke Volume in millilitres

BSA : Body Surface Area in square meters

7-28 SIGMA 110/SIGMA 330 15.10.01

D.4.3.2 Tricuspid Valve

• Right Ventricular Right Auricular Gradient in mmHg (RVRAGr)

2
RVRAGR D 4 ⋅ TRV

TRV : Tricuspid Regurgitation Velocity in meters per second

D.4.3.3 Continuity Equation

• Area in cm2 computed from 2D diameter (AREA1)

2
AREA1 D π ⋅ Diam -
-------------------------
4

Diam :Diameter in cm

• Area in cm2 computed from velocities (AREA2)

AREA1 ⋅ Vel1
AREA2 D --------------------------------------
Vel2

Vel1 : Velocity 1 in m/s

Vel2 : Velocity 2 in m/s

• Area in cm2 computed from velocities time integral (AREA2)

AREA2 D AREA1 ⋅ VTI1

--------------------------------------
VTI2

VTI1 : Velocity Time Integral 1 in cm

VTI2 : Velocity Time Integral 2 in cm

15.10.01 APPENDICES 7-29

 This page is intentionally left blank

7-30 SIGMA 110/SIGMA 330 15.10.01

Appendix E: Vascular Study

E.1 Description
14/01/98 08:30:31
LAB. : •••••••••••••••••••••••••••••••••••••••••••••••••••••
OPER. : •••••••••••••••••••••••••••••••••••••••••••••••••••••
NAME : •••••••••••••••••••••••••••••••••••••••••••••••••••••
EXAM.N:••••• SEX:•••H:000cm W:000.0kg AGE: 0y BSA: 0m2 HR:000b/mn
__ VASCULAR STUDIES ______________________________________________
STENOSIS PERCENTAGE SPEC. BROA. INDEX CONTINUITY EQUATION
Vel1[m/s] ____ VTI[cm] ____ Diam1[cm] ____
Vel2[m/s] ____ *TAMX[m/s] ÆAREA1[cm2]
ÆS%[%] *PkV[m/s] Vel1[m/s] ____
STENOSIS INDEX MVI[cm] ____ Vel2[m/s] ____
VTI[cm] ____ *TAV[m/s] ÆAREA2[cm2]
*TAMX[m/s] ÆSBI VTI1[cm] ____
*PkV[m/s] VTI2[cm] ____
ÆSTI CARDIAC OUTPUT ÆAREA2[cm2]
VOLUME VTI[cm] ____ RES.IND. PUL.IND.
d1[cm] ____ Diam[cm] ____ PI ____
d2[cm] ____ ÆSV[ml] *TAMX[m/s]
d3[cm] ____ ÆSI[ml/m2] *VELs[m/s]
ÆV[cm3] ÆCO[l/mn] *VELd[m/s]
VOLUME FLOW ÆCI[l/mn/m2] ÆVELs/VELd
MVI[cm] ____ HEART RATE RI ____
*TAV[m/s] HR[b/mn] ____ *VELs[m/s]
Diam[cm] ____ FREQUENCY *VELd[m/s]
ÆBF[l/mn] Freq[kHz] ____ ÆVELs/VELd

E.2 Stenosis Percentage

Vel1 : Velocity on the stenosis in m/s
Vel2 : Velocity before or after the stenosis in m/s
ÆS : Stenosis in percentage

a) Stenosis Index

VTI : Velocity Time Integral in cm

*TAMX : Time Average Maximum Velocity in m/s
*PkV : Peak Velocity in m/s
ÆSTI : Stenosis Index

E.2.1 Volume
d1 : Distance 1 in cm
d2 : Distance 2 in cm
d3 : Distance 3 in cm

15.10.01 APPENDICES 7-31

 ÆV : Vascular Volume in cm3

E.2.2 Volume Flow

MVI : Mean Velocity Integral in cm
*TAV : Time Average Velocity in m/s
Diam : Diameter of the vessel in cm
ÆBF : Blood Flow in l/mn

E.2.3 Spectral Broadening Index

VTI : Velocity Time Integral in cm
*TAMX : Time Average Maximum Velocity in m/s (Mean Velocity)
*PkV : Peak Velocity in m/s
MVI : Mean Velocity Integral in cm
*TAV : Time Average Velocity in m/s
ÆSBI : Spectral Broadening Index

E.2.4 Cardiac Output

VTI : Velocity Time Integral in cm
Diam : Diameter of the vessel in cm
ÆSV : Stroke Volume millilitres
ÆSI : Stroke Volume Index in millilitres per square meters
ÆCO : Cardiac Output litres per minute
ÆCI : Cardiac Output Index in litres per minute per square meters

E.2.5 Frequency
Freq : Doppler frequency shift in kHz

E.2.6 Heart Rate (SP or TM measurement)

HR : Measured Heart rate in beats per minutes. This field is used for the
computation of the aortic valve study sheet

E.2.7 Continuity Equations

Diam1 : Diameter 1 in cm
*AREA1 : Area 1 in cm2
Vel1 : Velocity 1 in m/s
Vel2 : Velocity 2 in m/s
ÆAREA2 : Area 2 with the Velocity in cm2
VTI1 : Velocity Time Integral 1 in cm
VTI2 : Velocity Time Integral 2 in cm
ÆAREA2 : Area 2 with the Velocity Time Integral in cm2

E.2.8 Resistance Index, Pulsatility Index

RI : Resistance Index
PI : Pulsatility Index
*Vels : Velocity at Systole in m/s
*Veld : Velocity at Diastole in m/s
*TAMX : Mean Velocity in m/s

7-32 SIGMA 110/SIGMA 330 15.10.01

 ÆVels/Veld : Ratio Velocity Systole/Diastole

The resistance index can be either deduced from the PI calculation or computed separately.
Since it can be computed separately, some parameters are duplicated.

E.3 Equations
E.3.1 Velocity Time Integral
• Velocity Time Integral (VTI) in cm

VTI= ∑ Vi ⋅ ∆t
D ⋅C
f
V D ----------------------------
-
2 ⋅ f 0 ⋅ cos α

Vi : Velocity (in m/s) during each Dt (in s) of measured spectral area

Df : Doppler frequency in Herz
C : Sound velocity (1540 m/s)
f0 : Ultrasound frequency in Herz
a : Angle between the ultrasound beam and blood velocity

E.3.2 Stenosis Percentage

• Stenosis percentage (S)

S D 1 Vel2
------------ ⋅ 100
 Vel1

Vel1 : Velocity on the stenosis in m/s

Vel2 : Velocity before or after the stenosis in m/s

E.3.3 Stenosis Index

• Time Average Maximum Velocity in metres per second (TAMX)
VTI -
TAMX D -------------
Time
VTI : Velocity Time Integral
Time : Duration flow in seconds

• Stenosis Index (STI)

STI D  1 TAMX ⋅ 0,9

 -----------------
PkV

TAMX : Time Average Maximum Velocity in m/s

PkV : Peak Velocity at systole in m/s

15.10.01 APPENDICES 7-33

E.3.4 Ellipsoid Volume
• Ellipsoid volume in cm3 (V)

D1 ⋅ D2 ⋅ D3
V D 4 ⁄ 3 ⋅ π ⋅ --------------------------------
8

D1 : Distance 1
D2 : Distance 2
D3 : Distance 3

E.3.5 Spectral Broadening Index

• Time Average Velocity in metres per second (TAV)

MVI
TAV D --------------
Time

MVI : Mean Velocity Time Integral

Time : Duration flow in seconds

• Time Average Maximum Velocity in metres per second (TAMX)

VTI
TAMX D --------------
Time

VTI : Velocity Time Integral

Time : Flow duration flow in seconds

• Spectral broadening Index (SBI)

TAV
SBI D  1 ----------------- ⋅ 100
 TAMX

TAV : Time Average Velocity in m/s

TAMX : Time Average Maximum Velocity in m/s

E.3.6 Cardiac Output

• Stroke Volume in millilitres (SV)

SV D area 2D ⋅ VTI
2
area 2D D π ⋅D-
--------------
4

VTI : Velocity time integral

D : Diameter of vessel in centimetres

• Stroke Index Volume in millilitres per square metres (SI)

SV
SI D ------------
BSA

SV : Stroke Volume in millilitres

BSA : Body Surface Area in square meters

7-34 SIGMA 110/SIGMA 330 15.10.01

 • Cardiac Output in litres per minute (CO

SV ⋅ HR
CO D ---------------------
1000

SV : Stroke Volume in millilitres

HR : Heart Rate in beats per minute

• Cardiac Index in litres per minute per square metres (CI)

CO
CI D -----------
-
BSA

CO : Cardiac Output in litres per minute

BSA : Body Surface Area in square meters

E.3.7 Volume Flow

• Time Average Velocity (TAV)
MVI
*TAV D --------------
Time

*TAV : Time Average Velocity in cm/s

MVI : Mean Velocity Integral in cm (corrected according to the angle)
Time : Duration flow in seconds

• Blood Flow using VMean (BF)

π 2
TAV ⋅ 60 ⋅ --- ⋅ D
4
BF D -------------------------------------------
1000
BF : Blood Flow in l/min.
TAV : Time Average Velocity in cm/s
D : Diameter of the vessel in cm

E.3.8 Continuity Equation

• Area in cm2 computed from 2D diameter (AREA1)
2
π ⋅ Diam
AREA1 D --------------------------
4

Diam :Diameter in cm

• Area in cm2 computed from velocities (AREA2)

AREA1 ⋅ Vel1
AREA2 D --------------------------------------
Vel2

Vel1 : Velocity 1 in m/s

Vel2 : Velocity 2 in m/s

15.10.01 APPENDICES 7-35

 • Area in cm2 computed from velocities time integral (AREA2)

AREA1 ⋅ VTI1
AREA2 D -------------------------------------
-
VTI2

VTI1 : Velocity Time Integral 1 in cm

VTI2 : Velocity Time Integral 2 in cm

E.3.9 Resistance Index, Pulsatility Index

• Time Average Maximum Velocity in metres per second (TAMX)

VTI
TAMX D -------------
-
Time

VTI : Velocity Time Integral

Time : Duration flow in seconds

• Resistance Index from Pourcelot (RI)

Vels Veld
RI D -------------------------------
Vels

Vels : Velocity at systole m/s

Veld : Velocity at diastole in m/s

• Pulsatility Index

Vels Veld
PI D -------------------------------
TAMX

Vels : Velocity at systole m/s

Veld : Velocity at diastole in m/s
TAMX : Time Average Maximum Velocity in m/s

7-36 SIGMA 110/SIGMA 330 15.10.01

Appendix F: Ob/Gyn Studies

F.1 2D Sheet
F.1.1 Description
14/03/01 08:30:31
LAB. : •••••••••••••••••••••••••••••••••••••••••••••••••••
OPER. : •••••••••••••••••••••••••••••••••••••••••••••••••••
NAME : •••••••••••••••••••••••••••••••••••••••••••••••••••
EXAM.N: •••••
__ OB/GYN STUDIES ____________________________________________
LMP : ../../.... NWA : wk EBD :

Meas(cm) AGE +/-

CRL : ____ ÆCI[%]
GES : ____ ÆHC/AC[%]
ChD : ____ ÆFML/AC[%]
BPD : ____ ÆFML/BPD[%]
BOD : ____
OFD : ____ WEIGHT[g]
HC : ____ +/-[g]
TAD : ____ AUA
APD : ____ AEBD
AC : ____
THD : ____
FML : ____
HuL : ____

*AC :
*HC :

Second function keys page

LMP : Last Menstrual Period

EBD : Estimated Birth Date
NWA : Number of Weeks of Amenorrhea

CRL : Crow Rump Length in cm

GES : Gestational Sac in cm
ChD : Chorion Diameter in cm
BPD : Biparietal Diameter in cm
BOD : Binocular Distance in cm
OFD : Occipital Frontal Diameter in cm

15.10.01 APPENDICES 7-37

 HC : Head Circumference in cm
TAD : Transabdominal Diameter in cm
APD : Anterior Posterior Diameter in cm
AC : Abdominal Circumference in cm
THD : Thoracic Diameter in cm
FML : Femur Length in cm
HuL : Humerus Length in cm
*AC : Abdominal Circumference Calculated in cm
*HC : Head Circumference Calculated in cm
ÆCI : Cephalic Index (BPD/OFD) in percentage
ÆHC/AC : Head Circumference / Abdominal Circumference
ÆFML/AC : Femur Length / Abdominal Circumference
ÆFML/BPD : Femur Length / Biparietal Diameter
WEIGHT : Foetal Weight in kg
+/- : Uncertainty in kg
AUA : Average Ultrasound Age in week
AEBD : Average Estimated Birth Date

F.1.2 Equations
• Estimated Foetal Age (Age) and uncertainty(+/-)
For each kind of measurement (BPD, FML,...), the foetal age and its uncertainty are esti-
mated according to Ob/Gyn curves. For more details on Ob/Gyn curves, see Appendix F.4,
“Setup Sheet”, on page 7-44.
• Estimated birth date (EBD)
EBD D LMP 0 280 days

LMP : Last Menstrual Period

• Numbers of Weeks of Amenorrhea

NWA D CurrentDate LMP

LMP : Last Menstrual Period

• Ratios
BPD
CI D ------------- ⋅ 100 valid if 14 ≤ AUA ≤ 40 weeks
OFD

HC
--------- valid if 13 ≤ AUA ≤ 42 weeks
AC

FML
------------ ⋅ 100 valid if 21 ≤ AUA ≤ 42 weeks
AC

FML
------------- ⋅ 100 valid if 23 ≤ AUA ≤ 40 weeks
BPD

CI : Cephalic Index
BPD : Biparietal Diameter in cm
OFD : Occipital Frontal Diameter in cm
HC : Head Circumference in cm
AC : Abdominal Circumference in cm

7-38 SIGMA 110/SIGMA 330 15.10.01

 • Calculated abdominal circumference in cm (*AC)
π ⋅ ( APD 0 TAD )
*AC D --------------------------------------------
2

APD : Anterior Posterior Diameter in cm

TAD : Transabdominal Diameter in cm

• Calculated head circumference in cm (*HC)

*HC D π ⋅ ( BPD 0 OFD -)

--------------------------------------------
2

BPD : Biparietal Diameter in cm

OFD : Occipital frontal Diameter in cm

• Average ultrasound age in weeks and days (AUA)

Average of non zero ultrasound age values calculated on BPD, FML, CRL, AC, HC values.
n

∑ UAi
i D1
AUA D ----------------------
n

• Average Estimated birth date (AEBD)

AEBD D CurrentDate 0 280 AUA

AUA : Average Ultrasound Age in days

• Foetal weight (Weight)

Four methods are proposed: the Shepard and Campbell methods are useful for western popula-
tion, while Hsieh and Woo methods are for asian people.
• Shepard method1: dependency on Abdominal Circumference and Biparietal Diameter
measurements:

log ( Weight ) D 1,2508 0 0,166 ⋅ BPD 0 0,046 ⋅ AC 2,646 ⋅ AC ⋅ BPD-

-------------------------------------------
10 1000

AC : Abdominal circumference in cm
BPD : Biparietal Diameter in cm
Weight : foetal weight in grams

1. Shepard, M. J. et al., "An Evaluation of Two Equations for Predicting Fetal Weight by Ultrasound", Ameri-
can Journal of Obstetrics and Gynaecology, 1982, Volume 142, Page 47

15.10.01 APPENDICES 7-39

 • Campbell method1 : dependency on Abdominal Circumference measurement
The foetal weight is accessed from the reference table shown below :

AC (cm) Weight (g) +/-

21 900 130
25 1510 210
31 2690 370
36 3640 490
38 3920 540
40 4100 580

AC : Abdominal circumference in cm

• Woo method2: dependency on Abdominal Circumference and Biparietal Diameter

measurements:

log ( Weight ) D 1,13 0 0,18 ⋅ BPD 0 0,05 ⋅ AC 3,35 ⋅ AC ⋅ BPD-

----------------------------------------
10 1000

AC : Abdominal circumference in cm
BPD : Biparietal Diameter in cm
Weight : foetal weight in gramms

• Hsieh method3: dependency on Abdominal Circumference and Biparietal Diameter-

measurements:

5,6541 ⋅ AC ⋅ BPD 1,5515 ⋅ AC 2 ⋅ BPD 1,9782 ⋅ AC 3 5,2594 ⋅ BPD

log 10( Weight ) D ----------------------------------------------- ------------------------------------------------ 0 -------------------------------- 0 -------------------------------- 0 2,13153
1000 10000 100000 100

AC : Abdominal circumference in cm
BPD : Biparietal Diameter in cm
Weight : foetal weight in gramms

1. Campbell, D. Wilkin, "Ultrasonic Measurement of Fetal Abdomen circumference in the estimation of fetal
weight", British Journal of Obstetrics and Gynaecology, Sept. 1975, Volume 82, No 9, pages 689 to 697
2. “Clinical Validation of Two Equations in Antenatal Prediction of Chinese Fetal Weight by Ultrasonography”,
FM Chang, HC Ko, BL Yao, CH Wu (J. Formosan Med. Assoc. 1991; 90:1086-92)
3. “Clinical Validation of Two Equations in Antenatal Prediction of Chinese Fetal Weight by Ultrasonography”,
FM Chang, HC Ko, BL Yao, CH Wu (J. Formosan Med. Assoc. 1991; 90:1086-92)

7-40 SIGMA 110/SIGMA 330 15.10.01

F.2 TM/SP Sheet
F.2.1 Description
14/01/98 08:30:31
LAB. : ••••••••••••••••••••••••••••••••••••••••••••••••••••
OPER. : ••••••••••••••••••••••••••••••••••••••••••••••••••••
NAME : ••••••••••••••••••••••••••••••••••••••••••••••••••••
EXAM.N: ••••• HR : ... b/mn
__ OB/GYN STUDIES ____________________________________________

HEART RATE: _ b/mn

Velocity: ____ m/s Frequency: ____ kHz

ARTERIES Uterine L. Uterine R. Umbilical Cerebral

PI ____ ____ ____ ____

*TAMX[m/s]
*VELs[m/s]
*VELd[m/s]
ÆVELs/VELd

RI ____ ____ ____ ____

*VELs[m/s]
*VELd[m/s]
ÆVELs/VELd

F.2.2 Second function keys page

F.2.2.1 TM and SP Measurement

Heart Rate : Foetal Heart Rate in b/mn

F.2.2.2 SP Measurement

a) Velocity and Frequency measurement

Velocity : Velocity in m/s

Frequency : Frequency in kHz

When one of these fields is measured, the others is automatically computed.

b) Resistance and Pulsatility Index:

Four groups of measurement are available: Uterine Left, Uterine Right, Umbilical and Cerebral.
For each group the following measurements are available:

15.10.01 APPENDICES 7-41

 *Vels : Velocity at Systole in m/s
*Veld : Velocity at Diastole in m/s
*TAMX : Mean Velocity in m/s
RI : Resistance Index
PI : Pulsatility Index
ÆVels/Veld : Ratio Velocity Systole/Diastole
The resistance index can be either deduced from the PI calculation or computed separately.
Since it can be computed separately, some parameters are duplicated.

F.2.3 Equation
• Time Average Maximum Velocity in metres per second (TAMX)

VTI
TAMX D --------------
Time

VTI : Velocity Time Integral

Time : Duration flow in seconds

• Resistance Index from Pourcelot (RI)

Vels Veld
RI D -------------------------------
Vels

Vels : Velocity at systole m/s

Veld : Velocity at diastole in m/s

• Pulsatility Index

PI D Vels Veld
-------------------------------
TAMX

Vels : Velocity at systole m/s

Veld : Velocity at diastole in m/s
TAMX : Time Average Maximum Velocity in m/s

7-42 SIGMA 110/SIGMA 330 15.10.01

F.3 Foetal Information Sheet
To access this page, the user must select the icon from one of the previous
screens.

If the user selects the icon from the fetal information sheet, the 2D or SP/TM
sheet will be displayed again, according to the current mode (2D, TM, ...)..
14/02/01 08:30:31
LAB. : •••••••••••••••••••••••••••••••••••••••••••••••••••••
OPER. : •••••••••••••••••••••••••••••••••••••••••••••••••••••
NAME : •••••••••••••••••••••••••••••••••••••••••••••••••••••
EXAM.N: •••••
__ PAROUS EXPERIENCE __________________________________________

GRAVIDITAS : ••• PARA Term : •••

Prema : •••
Abortion : •••
Living : •••

__ FETAL DESCRIPTION __________________________________________

GENDER : ••••• FETAL MOVEMENT : ••••••••••

FETAL BREATHING : ••••••••••
CARDIAC ACTIVITY :
•••••••••••••••••••••••••••••••••••••••••••••••••••••••

PRESENTATION :
•••••••••••••••••••••••••••••••••••••••••••••••••••••••
•••••••••••••••••••••••••••••••••••••••••••••••••••••••

Second function keys page

Information concerning Mother:

GRAVIDITAS : Number of pregnancies
Term : Number of birthes having reached time
Prema : Number of premature birthes
Abortion : Number of abortion
Living : Number of alive infant at birth

Information concerning Foetus:

FOETAL HEART RATE
FOETAL MOUVEMENT
FOETAL BREATHING
GENDER : most likely sex made on 2D images
PRESENTATION

15.10.01 APPENDICES 7-43

F.4 Setup Sheet
F.4.1 Description
The calculations collected in the obstetric/gynaecology package are designed to estimate the
age of a foetus according to the size of a specific body element (e.g., femur length, thoracic
diameter,...). The age is subsequently determined, using a reference table, where a linear inter-
polation is made for each measurement which lies between two tabulated points. For each
measurement, the user can use his personal table (see Appendix F.5, “User Table Sheet”, on
page 7-47), or a reference table.
To select the curves he wants to work with, the user must enter the user setup sheet by selecting
the softkey. The following screen is then displayed.

• First Page

14/02/01 08:30:31

__OB / GYN SETUP ____________________________________________

ChD
CRL ÷Rempen BOD
÷Robinson User ÷Jeanty
Hohler User
Chev/Jean BPD
Hansmann ÷Bessis OFD
Rempen Merz ÷Merz
User Hadlock User
Campbell
GES Chev/Hobb HC
÷Ramzin Hohl/Sabb ÷Hadlock
Hellman Hansmann Merz
Hansmann Lai/Yeo Lai/Yeo
User User User

The user selects a curve using the trackball and validates his choice with the <CURSOR_SET>
key. A tick is displayed in front of the selected curve.
If the user wants to work with his own curves, he selects the “USER” item. A specific screen is
displayed (see Appendix F.5, “User Table Sheet”, on page 7-47).
The user can also display an ob/gyn curve; once the curve label is video inverted, he presses the
icon.

7-44 SIGMA 110/SIGMA 330 15.10.01

 • Second page

14/02/01 08:30:31

__OB / GYN SETUP ____________________________________________

TAD THD HuL

÷Merz ÷Hansmann ÷Merz
User User Lai/Yeo
User
APD FML
÷Ramzin ÷Bessis WEIGHT
Bessis Hadlock ÷Shepard
Merz Obri/Camp Campbell
User Jeanty Hsieh
Hohler Woo
AC Merz
÷Hadlock Hansmann
Merz Lai/Yeo
Lai/Yeo User
User

F.4.2 Short Description of Reference Tables

The following table summarizes the reference tables. For more information, see the related page
in appendix 7.

Sound ve- Meas range Age range Error range

Meas Author locity (m/s) (cm) (wk) (wk)
AC Hadlock 1540 10-36.5 15.6-40.8 1.9-2.5 page 7-78
AC Merz 1540 6.2-34.3 12.5-41.5 1.2-3.6 page 7-79
AC Lai/Yeo 1540 8.7-34.1 15-41 0.8-2.1 page 7-80
APD Bessis 1540 2.5-8.8 14-37.2 1.2-4.8 page 7-69
APD Merz 1540 1.9-10.9 12.5-41.5 1.2-3.5 page 7-70
APD Ramzin 1540 5.18-10 22-40 3.5-4.5 page 7-69
BOD Jeanty 1540 1.5-6.5 10.4-40.1 0.7-2 page 7-84
BPD Bessis 1540 1.9-9.7 11.6-39.9 0.8-4.5 page 7-49
BPD Campbell 1540 2.3-9.8 13.1-40 0.2-2.2 page 7-50
BPD Hadlock 1540 2-10 12.2-42 0.8-3.6 page 7-51
BPD Hansmann 1600 1.6-9.8 11-39 1.2-5 page 7-52
BPD Hobbins 1540 1-6.8 9.1-26.4 2.7-2.7 page 7-54
BPD Hohler 1540 2-10 11.8-42.1 0-0 page 7-55
BPD Merz 1540 2.5-9.8 12.5-41.5 1.2-5.5 page 7-53

15.10.01 APPENDICES 7-45

 BPD Lai/Yeo 1540 2.5-9.6 14-41 0.8-3.3 page 7-56
ChD Rempen 1540 0.2-7.3 4.86-14.14 0.8 page 7-57
CRL Hansmann 1600 1.3-16.0 8-22 1.5-2.5 page 7-74
CRL Hohler 1540 0.6-7.8 6.3-14 0.34-0.34 page 7-72
CRL Jeanty 1540 0.6-5.4 6.6-12.1 0.7-0.7 page 7-73
CRL Rempen 1540 0.2-7.8 6-13.71 1.4 page 7-75
CRL Robinson 1540 0.42-7.78 6-14 0.6-0.8 page 7-71
FML Bessis 1540 1.04-7.34 13-41 1.0-4 page 7-58
FML Hadlock 1540 1-7.9 12.8-40.4 0.7-1.6 page 7-59
FML Hansmann 1600 1.4-7.5 15-40 1.0-3.5 page 7-62
FML Hohler 1540 1-8 12-40.8 0-0 page 7-61
FML Jeanty 1540 1-8 12.6-40 1.4-1.4 page 7-60
FML O'Brien 1540 1-4.6 12-23.5 0.5-0.5 page 7-60
FML Merz 1540 0.9-7.7 12.5-41.5 0.25-4 page 7-63
FML Lai/Yeo 1540 1.3-7.3 14-41 0.8-2.7 page 7-64
GES Hansmann 1540 0.7-3.4 2.9-7 1.1-1.1 page 7-77
GES Hellman 1540 0.4-4.7 4.7-10.3 1-1 page 7-76
GES Ramzin 1540 0.77-5.71 5-12 1.2-1.2 page 7-76
HC Hadlock 1540 8-36 13.4-41.6 1.3-3.4 page 7-81
HC Merz 1540 9.2-35 12.5-41.5 1-5.8 page 7-82
HC Lai/Yeo 1540 8.6-33 14-41 0.8-4 page 7-83
HuL Merz 1540 0.8-6.7 12.5-41.5 0.7-4.5 page 7-65
HuL Lai/Yeo 1540 1.9-6.1 16-41 1-4 page 7-66
OFD Merz 1540 3-11.5 12.5-41.5 1-6.5 page 7-84
TAD Merz 1540 2-11 12.5-41.5 1-3.5 page 7-67
THD Hansmann 1540 3.1-10.8 15.5-41 1.9-4.1 page 7-68

7-46 SIGMA 110/SIGMA 330 15.10.01

F.5 User Table Sheet
14/01/98 08:30:31

__OB / GYN SETUP ___________________________________________________

Sound velocity: 1540

cm wk +/-
1. ...... ...... ......
2. ...... ...... ......
3. ...... ...... ......
4. ...... ...... ......
5. ...... ..... ......
6 ..... ..... ......
7. ...... ...... ......
8. ...... ...... ......
9. ...... ...... ......
0. ...... ...... ......

When the user selects the USER item in the setup sheet, this page is displayed.
The user can here enter his own curve. The default sound velocity is set to 1540 m/s (reference
value). The user can enter a different value. In this case, the system automatically performs a
ratio between the reference value and the user velocity before computing the interpolation.

If he presses the icon, his curve is drawn on screen.

Note: the week and uncertainty values must be entered in week as a floating value (3 weeks and
2 days = 3.3 weeks).

15.10.01 APPENDICES 7-47

F.6 Curve View

When the user presses on the icon from one of the previous screens while a meas-
urement field (BPD, FML,...) or a gestational curve (Bessis in BPD group) is highlighted, the
corresponding curve is drawn on the screen. Others informations are also displayed as the
measured length, the NWA, the age.

14/01/98 08:30:31

BPD from Hadlock

cm

50

45

40

35

30

25
Length(cm) : 26.8
20 Age : 7 wk 5 d
+/- : 2 d
15

10 NWA: 7.5 wk

0 week
0 2 4 6 8 10

A point is displayed on the curve graph. This point matches the estimated information (Age,
length) if the NWA is lower than 15 weeks. When NWA is equal or greater than 15 weeks, the
displayed point matches the (NWA, length) information.

7-48 SIGMA 110/SIGMA 330 15.10.01

Appendix G: Reference Tables for Ob/Gyn

G.1 Biparietal Diameter (BPD)

G.1.1 BPD from Bessis
BPD (cm) EBD (week) +/-
1.9 11.6 0.8
2.35 13 0.8
3.65 17 0.8
4.9 21 1
6.05 25 1.3
7.2 29 1.7
8.15 33 2.6
8.75 37 4.5
9.7 39.9 4.5

BPD from Bessis

45

40

35

30

EBD (week)
25
EBD+ (week)
20 EBD- (week)

15

10

0
0 2 4 6 8 10
BPD (cm)

G.1.1.1 Source: The data are those provided by Dr. Bessis to M. Le Bel. (Same as SIGMA 20,
see memo from Ch. Gähwiller dated, June 23, 1983)

15.10.01 APPENDICES 7-49

G.1.2 BPD from Campbell
BPD (cm) EBD (week) +/-
2.3 13.1 0.2
3.4 15.2 0.4
5.7 22 0.4
6.4 23.9 0.5
7.5 27.7 0.6
8.9 33.2 1
9.5 37 1.9
9.8 40 2.2

BPD from Campbell

45

40

35

30

EBD (week)
25
EBD+ (week)
20 EBD- (week)

15

10

0
0 2 4 6 8 10
BPD (cm)

G.1.2.1 Source: S. Campbell; G.B. Newman. Growth of the fetal biparietal diameter during nor-
mal pregnancy. The Journal of Obstetrics and Gynaecology of the British Commonwealth.
78:513, June 1971.

7-50 SIGMA 110/SIGMA 330 15.10.01

G.1.3 BPD from Hadlock
BPD (cm) EBD (week) +/-
2 12.2 0.8
4 18 0.8
4.5 19.5 1.39
5 21.2 1.39
7 28.3 1.34
7.5 30.4 2
8.5 34.7 2
10 42 3.6

BPD from Hadlock

50

45

40

35

30
EBD (week)
25 EBD+ (week)
EBD- (week)
20

15

10

0
0 2 4 6 8 10
BPD (cm)

G.1.3.1 Source: Hadlock, F.P.: Deter, R.L.: Harist, B.: Park, S.K. Fetal Biparietal Diameter:
A Critical Re-evaluation of the Relation to Menstrual Age by Means of Real-time Ultrasound.
J. Ultrasound Med. 1:97, April 1982.

15.10.01 APPENDICES 7-51

G.1.4 BPD from Hansmann
BPD (cm) EBD (week) +/-
1.6 11 1.2
2.4 13 1.2
3.8 17 1.2
5.2 21 1.5
6.5 25 2
7.7 29 3
8.5 32 3.5
9.5 37 5
9.8 39 5

BPD from Hansmann

45

40

35

30

EBD (week)
25
EBD+ (week)
20 EBD- (week)

15

10

0
0 2 4 6 8 10
BPD (cm)

G.1.4.1 Source: The values provide from A. De Lavernette (Kontron France).

Author Dr. Hansmann

7-52 SIGMA 110/SIGMA 330 15.10.01

G.1.5 BPD from Merz
BPD (cm) EBD (week) +/-
2.5 12.5 1.5
3.5 16 1.2
4.6 19 1.2
5.7 22.5 1.5
6.7 25.5 1.6
7.7 29 2
8.5 32 2.5
9.2 35.5 4.2
9.6 38.5 4
9.8 41.5 5.5

BPD from Merz

50

45

40

35

30
EBD (week)

25 EBD+ (week)
EBD- (week)
20

15

10

0
0 2 4 6 8 10
BPD (cm)

G.1.5.1 Source: Eberhard Merz "Ultrasound in Gynecology and Obstetrics", Textbook and
Atlas, 1991, Georg Thieme Verlag

15.10.01 APPENDICES 7-53

G.1.6 BPD from Hobbins
BPD (cm) EBD (week) +/-
1 9.1 2.7
2.6 13.4 2.7
4.6 19 2.7
5.6 22.1 2.7
6.8 26.4 2.7

BPD from Hobbins

30

25

20

EBD (week)
15 EBD+ (week)
EBD- (week)

10

0
0 1 2 3 4 5 6 7
BPD (cm)

G.1.6.1 Source: Chervenak, F.A.: Jeanty, P.: Hobbins, J.C.: Current Status of Fetal Age and
Growth Assessment.

7-54 SIGMA 110/SIGMA 330 15.10.01

G.1.7 BPD from Hohler
BPD (cm) EBD (week) +/-
2 11.8 0
4.5 17.3 0
5.5 22 0
7 27.3 0
8 31.3 0
9 36.1 0
10 42.1 0

BPD from Hohler

45

40

35

30

25

20

15

10

0
0 2 4 6 8 10
BPD (cm)

G.1.7.1 The table values have been adapted from Sabbagha by Hohler.

Sabbagha, R.E.: Hughey, F.&M. Standardization of Sonar Cephalometry and Gestational Age.
Obstet. Gynecol. 52:402-406, 1978.

15.10.01 APPENDICES 7-55

G.1.8 BPD from Lai/Yeo

BPD (cm) EBD (week) +/-

2.85 14.8 0.8
4.38 19.0 0.9
5.39 22.0 1.0
6.33 25.0 1.2
7.18 28.0 1.4
7.93 31.0 1.7
8.37 33.0 1.9
8.76 35.0 2.4
9.09 37.0 3.0
9.19 37.7 3.3

BPD from Lai/Yeo

43.0

38.0

33.0
EBD+ (w eek)
28.0 EBD (w eek)
EBD- (w eek)
23.0

18.0

13.0
2 4 6 8 10
BPD (cm )

G.1.8.1 Source: F.M. Lai, G.S.H Yeo: Reference Charts of foetal biometry in Asian, Singapore
Med J 1995; Vol 36: 628-636

7-56 SIGMA 110/SIGMA 330 15.10.01

G.2 Chorion Diameter (ChD) from Rempen
ChD (cm) EBD (week) +/-
0.2 4.86 1.4
1 5.71 1.4
1.8 6.72 1.4
2.6 7.55 1.4
3.4 8.59 1.4
4.2 9.69 1.4
5 10.73 1.4
5.8 11.85 1.4
6.6 13 1.4
7.3 14.14 1.4

ChD from Rempen

16

14

12

10
EBD (week)

8 EBD+ (week)
EBD- (week)

0
0 2 4 6 8
ChD (cm)

15.10.01 APPENDICES 7-57

G.3 Femur Length (FML)
G.3.1 FML from Bessis
FML (cm) EBD (week) +/-
1.04 13 1
2.22 17 1.1
3.37 21 1.2
4.45 25 1.4
5.42 29 1.6
6.42 33 2.1
6.9 37 2.9
7.34 41 4

FML from Bessis

45

40

35

30

EBD (week)
25
EBD+ (week)
20 EBD- (week)

15

10

0
0 2 4 6 8
FML (cm)

G.3.1.1 Source: The data are those provided by Dr. Bessis to M. Le Bel. (Same as SIGMA 20,
see memo from Ch. Gähwiller dated, June 23, 1983)

7-58 SIGMA 110/SIGMA 330 15.10.01

G.3.2 FML from Hadlock
FML (cm) EBD (week) +/-
1 12.8 0.7
2 15.7 0.7
2.5 17.2 1.6
5 26.5 1.6
7.9 40.4 1.6

FML from Hadlock

45

40

35

30

EBD (week)
25
EBD+ (week)
20 EBD- (week)

15

10

0
0 2 4 6 8
FML (cm)

G.3.2.1 Source: publication

Title: Fetal Femur Length as a Predictor of Menstrual Age: Sonographically Measured.
Authors: F.P. Hadlock, R.B. Harrist, R.L. Deter, S.K. Park
Reference: Americal Journal Roentgenology, Vol 138, May 1982

15.10.01 APPENDICES 7-59

G.3.3 FML from O'Brien
FML (cm) EBD (week) +/-
1 12 0.5
4.6 23.5 0.5

G.3.3.1 Source: Jeanty, P.: Rodesh, F.: Delbeke, D.: Dumont, J.: Estimation of Gestational Age
from Measurements of Fetal Long Bones. J. Ultrasound Med. 3:75, 1984.

G.3.4 FML from Jeanty

FML (cm) EBD (week) +/-
1 12.6 1.4
2 15.9 1.4
3 19.4 1.4
4 23.1 1.4
5 27 1.4
6 31.1 1.4
7 35.5 1.4
8 40 1.4

FML from Jeanty

45

40

35

30

EBD (week)
25
EBD+ (week)
20 EBD- (week)

15

10

0
0 2 4 6 8
FML (cm)

G.3.4.1 Source: Jeanty, P.: Rodesh, F.: Delbeke, D.: Dumont, J.: Estimation of Gestational Age
from Measurements of Fetal Long Bones. J. Ultrasound Med. 3:75, 1984.

7-60 SIGMA 110/SIGMA 330 15.10.01

G.3.5 FML from Hohler
FML (cm) EBD (week) +/-
1 12 0
2.5 16.9 0
5 23.5 0
6 31 0
7 35.7 0
8 40.8 0

FML from Hohler

45

40

35

30

25

20

15

10

0
0 2 4 6 8
FML (cm)

G.3.5.1 Source: Hohler, C.W.: Quetel, T.A.

Fetal femur length: Equations for computer calculation of gestational age from ultrasound meas-
urements.
Am. J. Obstet. Gynecol. 143:479-481, 1982.

15.10.01 APPENDICES 7-61

G.3.6 FML from Hansmann

FML (cm) EBD (week) +/-

1.4 15 1
2.6 19 1.5
3.5 22 1.7
4.3 25 2
5.1 28 2.5
6 32 3
6.8 36 3.3
7.5 40 3.5

FML from Hansmann

45

40

35

30

EBD (week)
25
EBD+ (week)
20 EBD- (week)

15

10

0
0 2 4 6 8
FML (cm)

G.3.6.1 Source: Prof. Dr. Hansmann, Prof. Dr. Hackelöer und Prim. Prof. Dr. Staudach "Ultras-
challdiagnostik in Geburtshilfe und Gynäkologie", p. 413+418, ISBN Nr. 3-540-11428-9,
Springer-Verlag

7-62 SIGMA 110/SIGMA 330 15.10.01

G.3.7 FML from Merz
FML (cm) EBD (week) +/-
0.9 12.5 0.2
2.1 16 1
3 19 1.2
4 22.5 1.5
4.8 25.5 1.7
5.6 29 2.1
6.2 32 2.2
6.9 35.5 2.7
7.4 38.5 3
7.7 41.5 4

FML from Merz

50

45

40

35

30
EBD (week)

25 EBD+ (week)
EBD- (week)
20

15

10

0
0 2 4 6 8
FML (cm)

G.3.7.1 Source: Eberhard Merz "Ultrasound in Gynecology and Obstetrics", Textbook and
Atlas, 1991, Georg Thieme Verlag

15.10.01 APPENDICES 7-63

G.3.8 FML from Lai/Yeo

FML (cm) EBD (week) +/-

1.6 14.8 0.8
2.5 18.0 0.9
3.0 20.0 1.0
4.1 24.0 1.1
4.6 26.0 1.2
5.3 29.0 1.4
5.7 31.0 1.6
6.3 34.0 1.8
6.8 37.0 2.3
6.9 38.3 2.7

FML from Lai/Yeo

45,0

40,0
35,0
30,0
EBD (weeks)
25,0
"EBD+ (weeks)"
20,0
"EBD- (weeks)"
15,0
10,0
5,0
0,0
1,6 2,5 3,0 4,1 4,6 5,3 5,7 6,3 6,8 6,9
FML (cm)

G.3.8.1 Source: F.M. Lai, G.S.H Yeo: Reference Charts of foetal biometry in Asian, Singapore
Med J 1995; Vol 36: 628-636

7-64 SIGMA 110/SIGMA 330 15.10.01

G.4 Humerus Length (HuL)
G.4.1 Humerus Length (HuL) from Merz
HuL (cm) EBD (week) +/-
0.8 12.5 0.7
2 16 1
2.8 19 1.4
3.7 22.5 1.5
4.3 25.5 1.7
5 29 2
5.5 32 2.5
6.1 35.5 3.2
6.4 38.5 3.5
6.7 41.5 4.5

HuL from Merz

50

45

40

35

30
EBD (week)

25 EBD+ (week)
EBD- (week)
20

15

10

0
0 1 2 3 4 5 6 7
HuL (cm)

G.4.1.1 Source: Eberhard Merz "Ultrasound in Gynecology and Obstetrics", Textbook and
Atlas, 1991, Georg Thieme Verlag

15.10.01 APPENDICES 7-65

G.4.2 HuL from Lai/Yeo

HuL (cm) EBD (week) +/-

2.2 17.0 1.0
2.4 18.0 1.0
3.3 22.0 1.2
3.9 25.0 1.5
4.5 28.0 1.7
4.8 30.0 1.9
5.1 32.0 2.3
5.4 34.0 2.8
5.7 36.0 3.3
5.8 37.0 4.0

Hul from Lai/Yeo

45,0

40,0

35,0
EBD (weeks)
30,0 "EBD+ (weeks)"
"EBD- (weeks)
25,0

20,0

15,0
2,0 3,0 4,0 5,0 6,0
HuL (cm)

G.4.2.1 Source: F.M. Lai, G.S.H Yeo: Reference Charts of foetal biometry in Asian, Singapore
Med J 1995; Vol 36: 628-636

7-66 SIGMA 110/SIGMA 330 15.10.01

G.5 Transabdominal Diameter (TAD) from Merz
TAD (cm) EBD (week) +/-
2 12.5 1
3.2 16 1.2
4.3 19 1.6
5.5 22.5 1.6
6.5 25.5 1.7
7.6 29 2
8.5 32 2.4
9.6 35.5 2.9
10.4 38.5 2.7
11 41.5 3.5

TAD from Merz

45

40

35

30

25 EBD (week)
EBD+ (week)
20 EBD- (week)

15

10

0
0 2 4 6 8 10 12
TAD (cm)

G.5.0.1 Source: Eberhard Merz "Ultrasound in Gynecology and Obstetrics", Textbook and
Atlas, 1991, Georg Thieme Verlag

15.10.01 APPENDICES 7-67

G.6 Thoracic Diameter (THD) from Hansmann
THD (cm) EBD (week) +/-
3.1 15.5 1.9
5.19 22.5 2.5
7.79 31.5 3.3
9.35 36 3.7
10.8 41 4.1

THD from Hansmann

50

45

40

35

30
EBD (week)
25 EBD+ (week)
EBD- (week)
20

15

10

0
0 2 4 6 8 10 12
THD (cm)

G.6.0.1 Source: Hansmann (Ellison Roynon, Kontron Medical)

Sound Velocity: 1540 m/s (Values are scaled from a sound velocity of 1600 m/s as in the publica-
tion, 1540 m/s for the table).
Uncertainty: two standard deviation.

7-68 SIGMA 110/SIGMA 330 15.10.01

G.7 Anterior Posterior Diameter (APD)
G.7.1 APD from Ramzin
APD (cm) EBD (week) +/-
5.18 22 3.5
10 40 4.5

G.7.1.1 Source: Dr. Ramzin, Basel

Sound Velocity: 1540 m/s
Uncertainty: two standard deviation

G.7.2 APD from Bessis

APD from Bessis

45

40

35

30

25 EBD (week)
EBD+ (week)
20 EBD- (week)

15

10

0
0 2 4 6 8 10
APD (cm)

APD (cm) EBD (week) +/-

2.5 14 1.2
7 28.7 2.1
7.5 30.7 2.4
8 32.6 3.1
8.2 33.5 3.2
8.4 34.4 3.5
8.6 35.7 4.1
8.8 37.2 4.8

G.7.2.1 Source: The values have been picked on the graphic provided by Dr. Gortchakoff.
Author Dr. Bessis

15.10.01 APPENDICES 7-69

G.7.3 APD from Merz
APD (cm) EBD (week) +/-
1.9 12.5 1.2
3.1 16 1.2
4.2 19 1.4
5.4 22.5 1.7
6.3 25.5 1.9
7.5 29 2.1
8.4 32 2.4
9.4 35.5 2.7
10.2 38.5 3
10.9 41.5 3.5

APD from Merz

45

40

35

30

25 EBD (week)
EBD+ (week)
20 EBD- (week)

15

10

0
0 2 4 6 8 10 12
APD (cm)

G.7.3.1 Source: Ultrasound in Gynaecology and Obstetrics Textbook and Atlas, Thieme Medi-
cal Publishers, Inc., New York, 1991.

7-70 SIGMA 110/SIGMA 330 15.10.01

G.8 Crown Rump Length (CRL)
G.8.1 CRL from Robinson
CRL (cm) EBD (week) +/-
0.42 6 0.6
0.88 7 0.7
1.46 8 0.7
2.18 9 0.7
3.03 10 0.7
4.01 11 0.7
5.14 12 0.7
6.39 13 0.7
7.78 14 0.8

CRL from Robinson

16

14

12

10
EBD (week)
8 EBD+ (week)
EBD- (week)

0
0 2 4 6 8
CRL (cm)

G.8.1.1 Source: The data are those reported by Robinson and Flemming, Brit. J. Obst. Gyn.
V82, 1975, p. 702-710. (Same as SIGMA 20, see memo Ch. Gähwiler)
Author: Robinson
Sound Velocity: 1540 m/s (Values are scaled from a sound velocity of 1530 m/s as in the publica-
tion to 1540 m/s for the table).
Uncertainty: two standard deviation

15.10.01 APPENDICES 7-71

G.8.2 CRL from Hohler
CRL (cm) EBD (week) +/-
0.6 6.3 0.34
1.2 7.6 0.34
2.4 9.3 0.34
3.4 10.4 0.34
4.4 11.4 0.34
5.2 12 0.34
6 12.7 0.34
7.8 14 0.34

CRL from Hohler

16

14

12

10
EBD (week)
8 EBD+ (week)
EBD- (week)

0
0 2 4 6 8
CRL (cm)

G.8.2.1 Source: Charles W. Hohler; MD. University of Miami School of Medicine (Adapted from
Robinson & Flemming, BJ Obs & Gyn. 82, 702, 1975).

7-72 SIGMA 110/SIGMA 330 15.10.01

G.8.3 CRL from Jeanty
CRL (cm) EBD (week) +/-
0.6 6.6 0.7
1.6 8.1 0.7
1.8 8.6 0.7
2.4 9.1 0.7
2.6 9.6 0.7
4.2 11.1 0.7
4.4 11.1 0.7
5.4 12.1 0.7

CRL from Jeanty

14

12

10

8 EBD (week)
EBD+ (week)
EBD- (week)
6

0
0 1 2 3 4 5 6
CRL (cm)

G.8.3.1 Source: Chervenak, F.A.: Jeanty, P._ Hobbisn, J.C.: Current Status of Fetal Age and
Growth Assessment

15.10.01 APPENDICES 7-73

G.8.4 CRL from Hansmann
CRL (cm) EBD (week) +/-
1.3 8 1.5
1.8 9 1.5
2.6 10 1.5
6 13 2
9.7 16 1
12 18 1.5
14 20 2
15 21 2.5
16 22 2.5

CRL from Hansmann

25

20

15
EBD (week)
EBD+ (week)
EBD- (week)
10

0
0 5 10 15 20
CRL (cm)

G.8.4.1 Source: Dr. HAnsmann, "Ultraschalldiagnostik in Geburtshilfe und Gynäkologie", pages

419 to 421, Springer Verlag, ISBN 3-540-11428-9

7-74 SIGMA 110/SIGMA 330 15.10.01

G.8.5 CRL from Rempen
CRL (cm) EBD (week) +/-
0.2 6 0.8
1.1 7.28 0.8
1.9 8.28 0.8
2.8 9.43 0.8
3.6 10.28 0.8
4.5 11.14 0.8
5.3 11.86 0.8
6.2 12.57 0.8
7 13.14 0.8
7.8 13.71 0.8

CRL from Rempen

16

14

12

10
EBD (week)
8 EBD+ (week)
EBD- (week)

0
0 2 4 6 8
CRL (cm)

15.10.01 APPENDICES 7-75

G.9 Gestational Sac (GES)
G.9.1 GES from Ramzin
GES (cm) EBD (week) +/-
0.77 5 1.2
5.71 12 1.2

G.9.1.1 Source: Dr. Ramzin, Basel

Sound Velocity: 1540m/s
Uncertainty: two standard deviation

G.9.2 GES from Hellmann

GES (cm) EBD (week) +/-
0.4 4.7 1
4.7 10.3 1

G.9.2.1 Source: Provided by the marketing: Adapted from Hellmann, I.M.: Am. J. Obstet. Gyne-
col. 103 : 789, 1969; based on the average sac diameter in three dimensions.

7-76 SIGMA 110/SIGMA 330 15.10.01

G.9.3 GES from Hansmann
GES (cm) EBD (week) +/-
0.7 2.9 1.1
0.9 3.7 1.1
1 4 1.1
1.3 4.3 1.1
1.5 4.7 1.1
2.4 5.4 1.1
2.8 6.3 1.1
3.4 7 1.1

GES from Hansmann

EBD (week)
5
EBD+ (week)
4 EBD- (week)

0
0 0.5 1 1.5 2 2.5 3 3.5
GES (cm)

G.9.3.1 Source: Dr. Hansmann, "Ultraschalldiagnostik in Geburtshilfe und Gynäkologie", page

39, Springer Verlag, ISBN 3-540-11428-9

15.10.01 APPENDICES 7-77

G.10 Abdominal Circumference (AC)
G.10.1 AC from Hadlock

AC (cm) EBD (week) +/-

10 15.6 1.9
17.5 22.5 1.9
23 27.3 2
30 34.1 3
36.5 40.8 2.5

AC from Hadlock

45

40

35

30

EBD (week)
25
EBD+ (week)
20 EBD- (week)

15

10

0
0 10 20 30 40
AC (cm)

G.10.1.1 Source: F.P. Hadlock; R.L. Deter; R.B. Harrist; S.K. Park. Fetal Abdominal Circumfer-
ence as a Predictor of Menstrual Age. Am. J. Roentgenology. 139:367, 1982.

7-78 SIGMA 110/SIGMA 330 15.10.01

G.10.2 AC from Merz
AC (cm) EBD (week) +/-
6.2 12.5 1.2
10 16 1.2
13.2 19 1.4
17 22.5 1.6
20.2 25.5 1.8
23.7 29 2
26.6 32 2.3
29.8 35.5 2.7
32.3 38.5 2.9
34.3 41.5 3.6

AC from Merz

50

45

40

35

30
EBD (week)

25 EBD+ (week)
EBD- (week)
20

15

10

0
0 5 10 15 20 25 30 35
AC (cm)

G.10.2.1 Source: Ultrasound in Gynaecology and Obstetrics Textbook and Atlas, Thieme Medi-
cal Publishers, Inc., New York, 1991.

15.10.01 APPENDICES 7-79

G.10.3 AC from Lai/Yeo

AC (cm) EBD (week) +/-

9.6 15.8 0.8
14.5 20.0 1.0
19.9 25.0 1.2
22.0 27.0 1.4
23.0 28.0 1.5
23.9 29.0 1.4
25.9 31.0 1.7
28.6 34.0 2.0
30.3 36.0 2.1
32.3 38.5 2.5

AC from Lai/Yeo

45,0

40,0

35,0

30,0 EBD (weeks)

EBD+ (weeks)
25,0 EBD- (weeks)

20,0

15,0

10,0
5,0 10,0 15,0 20,0 25,0 30,0 35,0
AC (cm)

G.10.3.1 Source: F.M. Lai, G.S.H Yeo: Reference Charts of foetal biometry in Asian, Singapore
Med J 1995; Vol 36: 628-636

7-80 SIGMA 110/SIGMA 330 15.10.01

G.11 Head Circumference (HC)
G.11.1 HC from Hadlock
HC (cm) EBD (week) +/-
8 13.4 1.3
20 22.1 1.6
26 28 2.3
29 31.6 2.3
32 35.5 2.7
33.5 37.7 3.4
35 40 3.4
36 41.6 3.4

HC from Hadlock

45

40

35

30

EBD (week)
25
EBD+ (week)
20 EBD- (week)

15

10

0
0 10 20 30 40
HC (cm)

G.11.1.1 Source: F.P. Hadlock; R.L. Deter; R.B. Harrist; S.K. Park. Fetal Head Circumference:
Relation to Menstrual Age. Am. J. Roentgenology. 138:649, 1982

15.10.01 APPENDICES 7-81

G.11.2 HC from Merz
HC (cm) EBD (week) +/-
9.2 12.5 1.3
13 16 1
16.8 19 1
21.2 22.5 1.2
24.7 25.5 1.3
28.3 29 1.7
30.9 32 2.1
33.2 35.5 3.8
34.5 38.5 3.7
35 41.5 5.8

HC from Merz

50

45

40

35

30
EBD (week)

25 EBD+ (week)
EBD- (week)
20

15

10

0
0 5 10 15 20 25 30 35
HC (cm)

G.11.2.1 Source: Ultrasound in Gynaecology and Obstetrics Textbook and Atlas, Thieme Medi-
cal Publishers, Inc., New York, 1991.

7-82 SIGMA 110/SIGMA 330 15.10.01

G.11.3 HC from Lai/Yeo

HC (cm) EBD (week) +/-

9.7 14.8 0.8
16.7 20.0 0.9
20.3 23.0 1.1
22.5 25.0 1.1
25.5 28.0 1.3
27.3 30.0 1.6
28.1 31.0 1.7
30.2 34.0 2.2
30.8 35.0 2.5
31.8 37.0 4.0

HC from Lai/Yeo

45,0

40,0
35,0
30,0
EBD (weeks)
25,0
EBD+ (weeks)
20,0
EBD- (weeks)
15,0
10,0
5,0
0,0
0,0 5,0 10,0 15,0 20,0 25,0 30,0 35,0
HC (cm)

G.11.3.1 Source: F.M. Lai, G.S.H Yeo: Reference Charts of foetal biometry in Asian, Singapore
Med J 1995; Vol 36: 628-636

15.10.01 APPENDICES 7-83

G.12 Binocular Distance (BOD) from Jeanty
BOD (cm) EBD (week) +/-
1.5 10.4 0.7
6.5 40.1 2

G.12.0.1 Source: Jeanty, P.; Cantraine, F.; Cousaert, E.; Romero, R.; Hobbins, J.C. The Binocu-
lar Distance: A New Way to Estimate Fetal Age. J Ultrasound Med 3:241-243, 1984.

G.13 Occipital Frontal Diameter (OFD) from Merz

OFD (cm) EBD (week) +/-
3 12.5 1.2
4.3 16 1
5.6 19 1.4
7.1 22.5 1.2
8.2 25.5 1.5
9.4 29 2.2
10.2 32 2.4
11 35.5 3
11.3 38.5 4.5
11.5 41.5 6.5

OFD from Merz

50

45

40

35

30
EBD (week)

25 EBD+ (week)
EBD- (week)
20

15

10

0
0 2 4 6 8 10 12
OFD (cm)

G.13.0.1 Source: Ultrasound in Gynaecology and Obstetrics Textbook and Atlas, Thieme Medi-
cal Publishers, Inc., New York, 1991.

7-84 SIGMA 110/SIGMA 330 15.10.01

Appendix H: Radiology Study

H.1 Description

14/03/01 08:30:31
LAB. : •••••••••••••••••••••••••••••••••••••••••••••••••••••
OPER. : •••••••••••••••••••••••••••••••••••••••••••••••••••••
NAME : •••••••••••••••••••••••••••••••••••••••••••••••••••••
EXAM.N:••••• SEX:• H:...cm W:...kg AGE: y BSA: m2 HR:...b/mn
__ ABDO 2D STUDIES ____________________________________________
VOLUMES label1 label2 CARDIAC OUTPUT
Coeff. coeff1 coeff2
d1[cm] ____ ____ Diam[cm] ____
d2[cm] ____ ____
d3[cm] ____ ____ CONTINUITY EQUATION
ÆV[cm3] Diam1[cm] ____

VOLUMES label3 label4

Coeff. coeff3 coeff4
d1[cm] ____ ____
d2[cm] ____ ____
d3[cm] ____ ____
ÆV[cm3]
__ PAEDIATRICS STUDIES ________________________________________
HIP ANGLES
Alpha [dg] ____ Beta [dg] ____
ÆType ÆType

a) Volumes

Volume label : user-defined (label1, label2, label3, label4)

Coeff. : user-defined (coeff1, coeff2, coeff3, coeff4)
d1 : Distance 1 in cm
d2 : Distance 2 in cm
d3 : Distance 3 in cm
ÆV : Volume in cm3
Volume label and related coefficient can be defined by user.
By default, the system uses the following values:
Default Name Default Coeff.
label1 Ellipse 0.523
label2 Ellipse 0.523
label3 Thyroid 0.479
label4 Thyroid 0.479

15.10.01 APPENDICES 7-85

 b) Cardiac Output

Diam : Diameter of the vessel in cm

c) Continuity Equations

Diam1 : Diameter 1 in cm

d) Hip Angles

Alpha : Alpha angle in degrees

ÆType : Type of the Alpha angle
Beta : Beta Angle in degrees
ÆType : Type of the Beta angle

This measurement is made in 3 steps:

• The Baseline is a line drawn from the ilium to the epiphysis.
• The Alphaline is a line drawn from the triradiate cartilage to the lateral aspect of the bony
acetabulum.
• The Betaline is a line drawn from the lateral aspect of the labrum to the bony margin of
the acetabulum.

H.2 Equations
• Volumes in cm3

V D Coeff ⋅ D1 ⋅ D2 ⋅ D3

Coeff : User modifiable coefficient

D1 : Distance 1 in centimetres
D2 : Distance 2 in centimetres
D3 : Distance 3 in centimetres
V : Volume in cm3

• Ellipsoid Volumes in cm3 (by default)

D1 ⋅ D2 ⋅ D3
V D 4 ⁄ 3 ⋅ π ⋅ --------------------------------
8

D1 : Distance 1 in centimetres
D2 : Distance 2 in centimetres
D3 : Distance 3 in centimetres
V : Volume in cm3

7-86 SIGMA 110/SIGMA 330 15.10.01

 • Thyroid volumes in cm3 (by default)

V D 0,479 ⋅ D1 ⋅ D2 ⋅ D3

D1 : Distance 1 in centimetres
D2 : Distance 2 in centimetres
D3 : Distance 3 in centimetres
V : Volume in cm3

Reference:
W. Wiedermann, K. Wurster, H.Czempiel :
"Sonographie und Szintigraphie der Schilddrüse"

• HIP angles
• Alpha angle
The Alpha Angle is the angle formed by the Baseline and the Alphaline

Type = 6 if Alpha > =5

Type = 7 if Alpha ≥ 98#and Alpha ≤ 60
Type = 8###if Alpha < 43#
####
Type : #Type of the Alpha angle

• Beta angle :
The Beta Angle is the angle formed by the Baseline and the Betaline.

Type = 6 if Beta < <<

Type = 7 if Beta ≥ 55 and Beta ≤ 77
Type = 8###if Beta > 77
###
Type## : #Type of the Beta Angle

15.10.01 APPENDICES 7-87

 This page is intentionally left blank

7-88 SIGMA 110/SIGMA 330 15.10.01

Appendix I: Measurement Interface
A report sheet is a collection of fields ordered by function (Mitral Valve, Pulmonary Artery, ...) -
see screens description above. The user can fill the report in two ways:
• the report being displayed, the user activates a measurement by clicking on a field.
• after having done a measurement, the user can insert it in the report.

I.1 Doing a Measurement from Report

Press the REPORT key to display a report sheet on screen.

I.1.1 Operating Mode

To make a measurement, the user selects a main field by pointing it with the report cursor. If the
measurement is possible to do, the pointed field highlights. To start the related measurement,
the user clicks on the CURSOR SET keyboard key. Then, the ultrasound screen appears, and
the user starts the measurement. Now, the user can:
• move the trackball and finish the measurement; the report sheet is displayed again and all the
related fields are updated (main field, results fields and computed fields if all data are availa-
ble)
• abort the measurement and return to the report screen: he presses on the ESCAPE keyboard
key, no field is modified.
• abort the measurement, exit the report and return to a live image: he presses on the FREEZE
key, no field is modified.

When is a measurement possible to do?

Each measurement is associated to a specific mode. For example: 2D for area, TM for time, SP
for velocity integral. A measurement is possible to do if its related mode was displayed at screen
just before the user entered the report. The table below summarizes all the possible states:

Authorized
System mode Comments
measurements
2D or CFM 2D measurements
Double 2D 2D measurements
Quad 2D 2D measurements
Zoom 2D measurements
2D/TM or 2D measurements if TM is active, switch on 2D pad
CFM/TM TM measurements if 2D is active, switch on TM pad
TM TM measurements
2D measurements if SP is active, switch on 2D pad
2D/SP
SP measurements if 2D is active, switch on SP pad
2Di/SP or 2D measurements if SP is active, switch on 2D pad
CFMi/SP SP measurements if 2D is active, switch on SP pad

15.10.01 APPENDICES 7-89

I.1.2 Special Cases

I.1.2.1 Cardiac Output Diameter

This field duplicates the Cardiac Output Diameter field of the vascular study sheet.
When this field is modified, the value displayed in the vascular page is automatically updated and
conversely.

I.1.2.2 Continuity Equation Diameter

This field duplicates the Continuity Equation Diameter field of the vascular study sheet.
When this field is modified, the value displayed in the vascular page is automatically updated and
conversely.

I.1.2.3 Hip Angle

The hip angle is computed either from the Alpha or the Beta field.
Once a field is selected, the sigma switches to the frozen ultrasound image and the angle meas-
urement starts. This measurement is made in three steps:
step 1 : the user places his baseline
step 2 : the user places his alpha line
step 3 : the user places his betaline
The hip angle is then computed and the ultrasound image remains displayed. Here, the user can
correct the computed alpha and/or beta angles. This correction is needful to balance careless
mistakes. In fact, there are two values to define an angle between two lines.
C L1
A
b
a
B
D
L2

In the above example, a and b defines the same angle formed by L1 and L2. The computed
angle depends on the way the lines L1 and L2 are drawn: if drawing L1 from C to D and L2 from
B to A gives the angle b, then drawing L1 from C to D and L2 from A to B will gives the angle a.
Notice that the following relation is always right:
a=p-b
b is the complement of a to p
The following menu will be displayed while processing the hip angle measurement.

Compl. Compl. Finish

Alpha Beta Meas

If the user remarks the Alpha angle is bad because points are set in reverse order, then he
presses on the softkey1 “Complement Alpha” and adjusts the Alpha angle.

7-90 SIGMA 110/SIGMA 330 15.10.01

If the user remarks the Beta angle is bad because points are set in reverse order, then he
presses on the softkey2 “Complement Beta” and adjusts the Beta angle.
When all the angles are correct, he presses on the F5 “Finish Meas” or on the <CURSOR_SET>
key to return to the biometry screen.

I.1.2.4 Left Ventricle Study

• When the TM-measurement menu is displayed, both full and abbreviate version of the left
ventricle measurement are available.
When the user activates a TM-measurement on the left ventricle from the cardio report sheet,
the measurement is done in either abbreviate or full version, according to user preference.
User preferences are defined in the preference menu.

I.1.2.5 Automatic Integral

Velocity Integral can be made either in automatic or in manual mode. The default mode is
defined by user in a preference menu.
In automatic mode, the Vmax or the Vmean profile will be chosen, according to the current meas-
urement, as described hereunder:
Velocity
Profile Type
Integral
MVI VMean
PI VMax
VTI VMax

Table 7-1:
While measurement is in progress, the user can switch between manual or automatic mode.
Manual mode is only available with Vmax.

I.1.2.6 PI/RI Measurement

Computing the Pulsatility Index updates also the Resistance Index.

But, the Resistance Index can be computed separately.

I.1.2.7 Area Measurements

An area can be computed either with an ellipse or an area measurement, according to user’s
preferences.
User preferences are defined in the preference menu.

I.2 Importing Measurements in Report

The user can do a measurement from the measurement menu and can insert the last measure-
ment in the report sheet.

15.10.01 APPENDICES 7-91

I.2.1 Operating Mode
After having done a measurement from the measurement menu, the user can insert it in the
report. The user selects the suitable report sheet and moves the trackball cursor on the main
fields of interest. When a relevant field is pointed, it highlights to indicate the insertion is possi-
ble. The user then presses on the CURSOR SET key to insert the last measurement. All the
related results and computed fields are automatically updated if all data are available.
Note: to activate the import mode, the measurement menu must be displayed before entering
the report.

I.2.2 Special Cases

I.2.2.1 Ratio Measurement

All ratios measurement can be inserted in the corresponding fields (e.g. a distance/ratio can be
inserted in a distance field, a speed/ratio can be inserted in a speed field, ...)

I.2.2.2 PI and RI Measurement

A PI measurement can be inserted in the PI fields. The RI value is updated.

A RI measurement can be inserted in the RI field only.

I.2.2.3 Speed and Frequency

A speed measurement can be inserted in a frequency field and conversely.

A speed/ratio measurement can be inserted in a speed or in a frequency field.

I.2.2.4 Heart Rate and Time

A time measurement can be inserted in a heart rate field and conversely.

A time/ratio measurement can be inserted in a time or in a heart rate field.

I.2.2.5 Area Measurement

Both area and ellipse measurement can be inserted in the relevant report fields.
An Area/ratio measurement can be inserted in both area and ellipse fields.

I.2.2.6 Left Ventricle Study

Both abbreviate and full version of the left ventricle TM-measurement can be inserted in the rele-
vant report fields. Only the available data will be displayed for the abbreviate measurement.

I.2.2.7 Automatic Integral

Both manual and automatic integral can be inserted in the relevant report fields.

I.2.2.8 Hip Angle

This measurement cannot be imported because it is not available in the measurement menu.

7-92 SIGMA 110/SIGMA 330 15.10.01

Appendix J: Print Preview

J.1 Edit the Printable Report

To edit the printable report, the user must press on the icon.

The print preview is displayed according to the following template:

14/02/01 08:30:31
Name :

Measurement Results

Page 2/3

Like for the measurement page, the report page is divided in three parts :
• At the top of the page, the patient name is displayed.
• The second part contains the results of the different calculations which has been done
by the user. These results are sorted by medical application first and by measurement
group then.
For example, when the user has made measurement in different medical application, he
will find first the results of the vascular study measurement, then the abdominal study
measurements, .... The patient and laboratory information are always displayed at the
end of the report preview.

15.10.01 APPENDICES 7-93

 The following figure give an example of a print preview screen.
.
DUBOIS 14/02/01 08:30:31

RADIOLOGY STUDY

STENOSIS PERCENTAGE
Velocity on the Stenosis : 0.42 m/s
Velocity forward or backward the stenosis : 0.62 m/s
Stenosis Percentage : 48.92 %

STENOSIS INDEX
Velocity Time Integral : 71.75 cm
Time Average Maximum Velocity : 0.94 m/s
Peak Velocity : 1.07 m/s
Stenosis Index : 0.11

VASCULAR VOLUME
Diameter 1 : 6.58 cm
Diameter 2 : 3.28 cm
Diameter 3 : 4.94 cm
Vasc. Volume : 55.44 cm3

Page 1/3

• The print preview will be modified according to printout improvements.

• The third part contains the different tools icons. See Appendix B, “Report Menu”, on
page 7-5 for more information.

J.2 Print the Report on an External Printer

The user can here print the whole study on an external printer. To do this, he must press the
icon.

J.3 Save the Report on a Flashcard

The user can store the report in a text file on the flashcard. To do this, the KIPRISM option must
be enabled and he must press the icon.

7-94 SIGMA 110/SIGMA 330 15.10.01

Appendix K: KIPRISM / SonoWin® Basic
Conversion Tables

K.1 Overview
This section describes the correspondance between the SIGMA measurement values and the
SonoWin® Basic ones. These correspondances are shown in tables sorted by medical applica-
tion and have to be read as shown below:

Description SIGMA SonoWin® Chapter

Long Axis Length at diastole LALd cm LVLD mm Card 2D LV Single Plane

Description as found in SIGMA SonoWin® The package where

Appendix D to H sections. measurement measurement the measurement is
name and unit. name and unit. stored in SonoWin®
database.

K.2 Cardiology Measurements

K.2.1 Left Ventricle study

K.2.1.1 2D measures (Single Plane)

Description SIGMA SonoWin® Chapter

Long Axis Length at diastole LALd cm LVLD mm Card 2D LV Single Plane
Long Axis Area at diastole LAAd cm2 LVALD cm2 Card 2D LV Single Plane
Long Axis Length at systole LALs cm LVLS mm Card 2D LV Single Plane
Long Axis Area at systole LAAs cm2 LVALS cm2 Card 2D LV Single Plane
Diastolic Volume VOLd cm3 EDV ml Card 2D LV Simpson’s Rule
Systolic Volume VOLs cm3 ESV ml Card 2D LV Simpson’s Rule
Ejection Fraction EF % EF Card 2D LV Simpson’s Rule
Stroke Volume SV ml SV ml Card 2D LV Single Plane
Stroke Index SI ml SI ml/m2 Card 2D LV Single Plane
Cardiac Output CO l/min CO l/min Card 2D LV Single Plane
Cardiac Index CI l/min/m2 CI l/min/m2 Card 2D LV Single Plane

15.10.01 APPENDICES 7-95

K.2.1.2 2D measures (Simpson)

Description SIGMA SonoWin® Chapter

Short Axis Area 1 at Diastole SAA1d cm2 LVAMD cm2 Card 2D LV Biplane
Short Axis Area 2 at Diastole SAA2d cm2 LVAPD cm2 Card 2D LV Simpson’s Rule
Long Axis Length at Diastole LALd cm LVLD mm Card 2D LV Simpson’s Rule
Short Axis Area 1 at Systole SAA1s cm2 LVAMS cm2 Card 2D LV Biplane
Short Axis Area 2 at Systole SAA2s cm2 LVAPS cm2 Card 2D LV Simpson’s Rule
Long Axis Length at Systole LALs cm LVLS mm Card 2D LV Simpson’s Rule
Diastolic Volume VOLd cm3 EDV ml Card 2D LV Biplane
Systolic Volume VOLs cm3 ESV ml Card 2D LV Biplane
Ejection Fraction EF % EF - Card 2D LV Biplane
Cardiac Output CO l/min CO l/min Card 2D LV Simpson’s Rule
Cardiac Index CI l/min/m2 CI l/min/m2 Card 2D LV Simpson’s Rule
Stroke Volume SV ml SV ml Card 2D LV Biplane
Stroke Index SI ml/m2 SI ml/m2 Card 2D LV Biplane

K.2.1.3 TM measures (Teichholtz)

Description SIGMA SonoWin® Chapter

Right Ventricle Diameter at diastole RVDd cm RVDD mm Card M LV Teichholtz
Inter Ventricular Septal Thickness at
IVSd cm IVSTS mm Card M LV Teichholtz
diastole
Left Ventricle Diameter at diastole LVDd cm LVIDD mm Card M LV Teichholtz
Posterior Left Ventricular Wall at dias-
PLVWd cm LVPWD mm Card M LV Teichholtz
tole
Inter Ventricular Septal Thickness at
IVSs cm IVSTS mm Card M LV Teichholtz
systole
Left Ventricle Diameter at systole LVDs cm LVIDS mm Card M LV Teichholtz
Posterior Left Ventricular Wall at systole PLVWs cm LVPWS mm Card M LV Teichholtz
Left Ventricle Ejection Time LVET sec ET ms Card M LV Teichholtz
Diastolic Volume (Teichholz formula) VOLd cm3 EDV ml Card M LV Teichholtz
Systolic Volume (Teichholz formula) VOLs cm3 ESV ml Card M LV Teichholtz
Shortening Fraction SF % FS - Card M LV Teichholtz
Left Ventricle Mass LVM gr LV_mass g Card M LV Teichholtz
Left Ventricle Mass Index LVMI gr/m2 LV_massI g/m2 Card M LV Teichholtz
Velocity of Circumferential Fibre Short-
VCF circ/sec MVCF circ/s Card M LV Teichholtz
ening
Ejection Fraction EF % EF - Card M LV Teichholtz
Stroke Volume SV ml SV ml Card M LV Teichholtz
Stroke Volume Index SI ml/m2 SI ml/m2 Card M LV Teichholtz
Cardiac Output CO l/min CO l/min Card M LV Teichholtz
Cardiac Output Index CI l/min/m2 CI l/min/m2 Card M LV Teichholtz
Ratio Left Ventricular Wall (diastole) on LVPWD/
H/R - - Card M LV Teichholtz
Left Ventricle Radius (diastole) LVIDD

7-96 SIGMA 110/SIGMA 330 15.10.01

K.2.1.4 Heart rate (TM and SP measurement)

Description SIGMA SonoWin® Chapter

Heart rate measured on Left
HR bpm HR bpm Card 2D LV Simpson’s Rule
Ventricle

K.2.2 Mitral Valve page

K.2.2.1 2D measures

Description SIGMA SonoWin® Chapter

Mitral Valve Diameter MVD cm DIAM mm Card D Mitral Value
Mitral Valve Area MVA cm2 VA1 mm2 Card D Mitral Value

K.2.2.2 TM measures

Description SIGMA SonoWin® Chapter

Slope between E- and F-waves EFsl cm/s EFSLP mm/s Card M MV and Aorta
Distance from E-wave to septum ESd cm EIVS_d mm Card M MV and Aorta

K.2.2.3 SP measures

Description SIGMA SonoWin® Chapter

Velocity Time Integral VTI cm VTI m Card D Mitral Valve
(VTI) Peak Velocity PkV m/s Vpeak_calc m/s Card D Mitral Valve
(VTI) Peak Gradient PkG mmHg peakPG mmHg Card D Mitral Valve
(VTI) Mean Gradient MnG mmHg meanPG mmHg Card D Mitral Valve
Peak Velocity for the E-wave PkVE m/s E VEL m/s Card D Mitral Valve
Peak Velocity for the A-wave PkVA m/s A VEL m/s Card D Mitral Valve
IsoVolumetric Relaxation Time IVRT sec IRT ms Card D Mitral Valve
Ratio Peak Velocity E-wave on Peak
E/A - E/A - Card D Mitral Valve
Velocity A-wave (PkVE/PkVA)
Stroke Volume SV ml SV ml Card D Mitral Valve
Stroke Volume Index SI m2 SI ml/m2 Card D Mitral Valve
Cardiac Output CO l/min CO l/min Card D Mitral Valve
Cardiac Output Index CI l/min/m2 CI l/min/m2 Card D Mitral Valve

K.2.2.4 Heart rate (TM or SP measurement)

Description SIGMA SonoWin® Chapter

Patient heart rate in beats per
HR bpm HR bpm Card D Mitral Valve
minutes on mitral valve

15.10.01 APPENDICES 7-97

K.2.2.5 Mitral Valve Effective Opening Area

Description SIGMA SonoWin® Chapter

Sub Aortic Diameter SAD cm DIAM mm Card D Mitral Valve
Area computed from DiamAOV SAA cm2 VA2 mm2 Card D Mitral Valve
Sub Aortic Velocity Time Integral VTIaov cm VTI11 m Card D Mitral Valve
Velocity Time Integral at Mitral
VTImv cm VTI12 m Card D Mitral Valve
Valve
Mitral Valve EOA computed from
EOA cm2 MVA2 mm2 Card D Mitral Valve
VTIaov and VTImiv
Pressure Half Time PHT msec PHT ms Card D Mitral Valve
Peak Velocity for E-wave PkVE m/s Vpeak1 m/s Card D Mitral Valve
Valve Area computed from Pres-
EOA cm2 MVA cm2 Card D Mitral Valve
sure Half Time

K.2.3 Aortic Valve

K.2.3.1 2D study

Description SIGMA SonoWin® Chapter

Aortic Valve Diameter AVD cm DIAM mm Card D Mitral Valve
Aortic Valve Area AVA cm2 MVA cm2 Card D Mitral Valve

K.2.3.2 SP study

Description SIGMA SonoWin® Chapter

Velocity Time Integral VTI cm VTI m Card D Aortic Valve
(VTI) Peak Velocity PkV m/s Vpeak_calc m/s Card D Aortic Valve
(VTI) Peak Gradient PkG mmHg peakPG_calc mmHg Card D Aortic Valve
(VTI) Mean Gradient MnG mmHg meanPC_calc mmHg Card D Aortic Valve
Pressure Half Time PHT msec PHT ms Card D Aortic Valve
Left Ventricle Pre Ejection
LVPEP sec PEP ms Card M MV and Aorta
Period
Stroke Volume SV ml SV ml Card D Aortic Valve
Stroke Volume Index SI ml/m2 SI ml/m2 Card D Aortic Valve
Cardiac Output CO l/min CO l/min Card D Aortic Valve
Cardiac Output Index CI l/min/m2 CI l/min/m2 Card D Aortic Valve

K.2.3.3 TM study

Description SIGMA SonoWin® Chapter

End diastolic Aortic Root diameter AoD cm AOD mm Card M MV and Aorta
Left Atrial end systolic diameter LAD cm LAD mm Card M MV and Aorta
Aortic Valve Opening AVO cm AVD mm Card M MV and Aorta
Left Ventricle Ejection Time LVET sec ET ms Card M MV and Aorta
Left Ventricle Pre-Ejection Period LVPEP sec PEP ms Card M MV and Aorta
Ratio Left Atrial, Aortic Root Diameter LAD/AoD - LA/AO - Card M MV and Aorta

7-98 SIGMA 110/SIGMA 330 15.10.01

 Description SIGMA SonoWin® Chapter
LVPEP/
Ratio Pre Ejection Period, Ejection Time - PEP/ET - Card M MV and Aorta
LVET

K.2.3.4 Effective Opening Area

Description SIGMA SonoWin® Chapter

Left Ventricle Output Trunk Diameter LVOTD cm LVOT mm Card D Aortic Valve
Area computed from Dlvot LVOTA cm2 LVOT_AREA cm2 Card D Aortic Valve
Velocity Time Integral at Left Ventricle Out-
VTIlvot cm VTI1 m Card D Aortic Valve
put Trunk
Velocity Time Integral at Aortic Valve VTIao cm VTI2 m Card D Aortic Valve
Effective Opening Area of the Aortic Valve EOA cm2 AREA_VTI12 cm2 Card D Aortic Valve
m/
Velocity at Aortic Valve Vao V1 m/s Card D Aortic Valve
sec
m/
Velocity at Left Ventricle Output Trunk Vlvot V2 m/s Card D Aortic Valve
sec
Effective Opening Area of the Aortic Valve EOA cm2 AREA_V12 cm2 Card D Aortic Valve

K.2.3.5 Left Ventricle Output Trunk

• 2D study:
Description SIGMA SonoWin® Chapter
LVOT Diameter LVOTD cm OT_D mm Card D Aortic Valve
LVOT Area LVOTA cm2 OT_AREA cm2 Card D Aortic Valve

• SP study:
Description SIGMA SonoWin® Chapter
Velocity Time Integral VTI cm VTI m Card D Aortic Valve
Peak Velocity PkV m/s Vmax m/s Card D Aortic Valve
Peak Gradient PkG mmHg peakPG mmHg Card D Aortic Valve
Mean Gradient MnG mmHg meanPG mmHg Card D Aortic Valve
Stroke Volume SV ml SV ml Card D Aortic Valve
Stroke Volume Index SI ml/m2 SI ml/m2 Card D Aortic Valve
Cardiac Output CO l/min CO l/min Card D Aortic Valve
Cardiac Output Index CI l/min/m2 CI l/min/m2 Card D Aortic Valve

K.2.3.6 Descending Aorta (SP measurement)

Description SIGMA SonoWin® Chapter

Velocity Time Integral at
VTIs cm AOdesc_VTI_s m Card D Aortic Valve
Systole
Velocity Time Integral at
VTId cm AOdesc_VTI_d m Card D Aortic Valve
Diastole
Ratio VTI Diastole, VTI Sys-
VTId/VTIs - VTI_d/VTI_s - Card D Aortic Valve
tole

15.10.01 APPENDICES 7-99

K.2.3.7 Heart Rate (TM or SP measurement)

Description SIGMA SonoWin® Chapter

Heart Rate on aortic valve HR bpm HR bpm Card D Aortic Valve

K.2.4 Right Ventricle study

K.2.4.1 Pulmonic Valve

• 2D measures:
Description SIGMA SonoWin® Chapter
Pulmonary Artery Diameter PAD cm PAD mm Card D Pulmonic Valve

• SP measures:
Description SIGMA SonoWin® Chapter
Velocity Time Integral VTI cm VTI m Card D Pulmonic Valve
Peak Velocity PkV m/s Vpeak_calc m/s Card D Pulmonic Valve
Peak Gradient PkG mmHg peakPG_calc mmHg Card D Pulmonic Valve
Mean Gradient MnG mmHg meanPG_calc mmHg Card D Pulmonic Valve
Right Ventricle Pre Ejection
RVPEP sec PEP ms Card D Pulmonic Valve
Period
Stroke Volume SV ml SV ml Card D Pulmonic Valve
Stroke Volume Index SI ml/m2 SI ml/m2 Card D Pulmonic Valve
Cardiac Output CO l/min CO l/min Card D Pulmonic Valve
Cardiac Output Index CI l/min/m2 CI l/min/m2 Card D Pulmonic Valve

K.2.4.2 Tricuspid Valve

• TM measures:
Description SIGMA SonoWin® Chapter
Slope between D- and E-wave DEsl cm/s RV_DESLP mm/s Card M MV and Aorta

• SP measures:
Description SIGMA SonoWin® Chapter
Tricuspid Regurgitation Velocity TRV m/s Reg_V m/s Card D Pulmonic Valve
Right Ventricular Right Atrial
RVRAGr mmHg peakPG mmHg Card D Pulmonic Valve
Gradient

K.2.4.3 Continuity equation (Free measurement)

• 2D measures:
Description SIGMA SonoWin® Chapter
Diameter Diam cm DIAM mm Card D Pulmonic Valve
Area 1 computed from Diam1 AREA1 cm2 AreaD cm2 Card D Pulmonic Valve

7-100 SIGMA 110/SIGMA 330 15.10.01

 • SP measures:
Description SIGMA SonoWin® Chapter
Velocity Time Integral 1 VTI1 cm VTI1 m Card D Pulmonic Valve
Velocity Time Integral 2 VTI2 cm VTI2 m Card D Pulmonic Valve
Area 2 computed from VTI1 and
AREA2 cm2 A1 cm2 Card D Pulmonic Valve
VTI2
Velocity 1 Vel1 m/sec V1 m/s Card D Pulmonic Valve
Velocity 2 Vel2 m/sec V2 m/s Card D Pulmonic Valve
Area 2 in cm2 computed from
AREA2 cm2 A2 cm2 Card D Pulmonic Valve
VEL1 and VEL2

K.2.4.4 Heart rate (SP or TM measurement)

Description SIGMA SonoWin® Chapter

Heart rate on right ventricle HR bpm HR bpm Card D Pulmonic Valve

15.10.01 APPENDICES 7-101

K.3 Vascular measurements
K.3.1 Stenosis Percentage

Description SIGMA SonoWin® Chapter

Velocity on the stenosis Vel1 m/s VMT2 m/s Angio Flow Volume (Vmean)
Velocity before or after the stenosis Vel2 m/s VMB2 m/s Angio Flow Volume (Vmean)
Stenosis S % D1%S % Angio Stenosis %

K.3.2 Stenosis Index

Description SIGMA SonoWin® Chapter

Velocity Time Integral VTI cm VTI1 m Angio Flow Volume (VTI)
Time Average Maximum Velocity TAMX m/s VMB1 m/s Angio Flow Volume (VTI)
Peak Velocity PkV m/s VMT1 m/s Angio Flow Volume (VTI)
Stenosis Index STI - STI - Angio Flow Volume (VTI)

K.3.3 Volume

Description SIGMA SonoWin® Chapter

Distance 1 d1 cm Tumor4_L mm Small Parts Mamma
Distance 2 d2 cm Tumor4_H mm Small Parts Mamma
Distance 3 d3 cm Tumor4_W mm Small Parts Mamma
Angio Volume V cm3 Tumor4_V mm3 Small Parts Mamma

K.3.4 Volume flow

Description SIGMA SonoWin® Chapter

Mean Velocity Integral MVI cm VTI2 m Angio Flow Volume (VTI)
Time Average Velocity TAV m/s Vmean1 m/s Angio Flow Volume (VTI)
Diameter of the vessel Diam cm Diam mm Angio Flow Volume (VTI)
Blood Flow BF l/mn FVOL1 l/min Angio Doppler Auto Trace

K.3.5 Spectral Broadening Index

Description SIGMA SonoWin® Chapter

Velocity Time Integral VTI cm VTI2 m Angio Flow Volume (VTI)
Time Average Maximum Velocity
TAMX m/s MV2 m/s Angio Doppler Auto Trace
(Mean Velocity)
Peak Velocity PkV m/s MV1 m/s Angio Doppler Auto Trace
Mean Velocity Integral MVI cm VTI1 m Angio Flow Volume (VTI)
Time Average Velocity TAV m/s Vmean2 m/s Angio Flow Volume (VTI)
Spectral Broadening Index SBI - SBI - Angio Flow Volume (VTI)

7-102 SIGMA 110/SIGMA 330 15.10.01

K.3.6 Cardiac Output

Description SIGMA SonoWin® Chapter

Velocity Time Integral VTI cm VTI1 m Angio Flow Volume (VTI)
Diameter of the vessel Diam cm Diam mm Angio Doppler Auto Trace
Stroke Volume SV ml SV2 ml Angio Flow Volume (VTI)
Stroke Volume Index SI ml/m2 CI2 ml/m2 Angio Flow Volume (VTI)
Cardiac Output CO l/min CO1 l/min Angio Flow Volume (VTI)
Cardiac Output Index CI l/min/m2 CI1 l/min/m2 Angio Flow Volume (VTI)

K.3.7 Frequency

Description SIGMA SonoWin® Chapter

Doppler frequency shift Freq kHz Frequ Hz Angio Flow Volume (VTI)

K.3.8 Heart rate (SP or TM measurement)

Description SIGMA SonoWin® Chapter

Measured Heart rate HR bpm Vasc_HR bpm Angio Flow Volume (VTI)

K.3.9 Continuity Equations

Description SIGMA SonoWin® Chapter

Diameter 1 Diam1 cm Diam mm Angio Doppler Auto Trace
Area 1 AREA1 cm2 AREA1 mm2 Angio Doppler Auto Trace
Velocity 1 Vel1 m/s VpeakS1 m/s Angio Doppler Auto Trace
Velocity 2 Vel2 m/s VpeakS2 m/s Angio Doppler Auto Trace
Area 2 with the Velocity AREA2 cm2 AREA1 mm2 Angio Flow Volume (VTI)
Velocity Time Integral 1 VTI1 cm VTI1 m Angio Flow Volume (VTI)
Velocity Time Integral 2 VTI2 cm VTI2 m Angio Flow Volume (VTI)
Area 2 with the Velocity Time
AREA2 cm2 AREA2 mm2 Angio Flow Volume (VTI)
Integral

K.3.10 Resistance Index, Pulsatility Index

Description SIGMA SonoWin® Chapter

Pulsatility Index PI - PI1 - Angio Doppler Auto Trace
• Mean Velocity TAMX m/s Vmean_P1 m/s Angio Doppler Auto Trace
• Velocity at Systole Vels m/s VpeakS1 m/s Angio Doppler Auto Trace
• Velocity at Diastole Veld m/s VED1 m/s Angio Doppler Auto Trace
• Ratio Velocity Systole/Diastole Vels/Veld - S/D1 - Angio Doppler Auto Trace
Resistance Index RI - RI1 - Angio Doppler Auto Trace
• Velocity at Systole Vels m/s VpeakS2 m/s Angio Doppler Auto Trace
• Velocity at Diastole Veld m/s VED2 m/s Angio Doppler Auto Trace
• Ratio Velocity Systole/Diastole Vels/Veld - S/D2 - Angio Doppler Auto Trace

15.10.01 APPENDICES 7-103

K.4 Obstetric and Gynaecology
K.4.1 2D measures
In the following table, SonoWin® defines
Description SIGMA SonoWin® Chapter
Last Menstrual Period LMP Date LMP Date Patient data
Estimated Birth Date EBD Date EDD Date Patient data
weeks
Number of Weeks of Amenorrhea NWA weeks DGA + Patient data
days
CRL,
Crow Rump Length CRL see a CRL_WEK, see b Ob Fet 1
CRL_SD
see see
<nor- <nor-
mal>< SAC, mal><s
Gestational Sac GES super- SAC_WEK, uper- Ob Fet 1
script SAC_SD script>b
>a<no <nor-
rmal> mal>

see see
<nor- <nor-
mal>< CHD, mal><
Chorion Diameter ChD super- CHD_WEK, super- Ob Fet 1
script CHD_SD script
>a<no >b<no
rmal> rmal>
see see
<nor- <nor-
mal>< BPD, mal><
Biparietal Diameter BPD super- BPD_WEK, super- Ob Fet 1
script BPD_SD script
>a<no >b<no
rmal> rmal>
see see
<nor- <nor-
mal>< ORB, mal><
Binocular Distance BOD super- ORB_WEK, super- Ob Fet 1
script ORB_SD script
>a<no >b<no
rmal> rmal>
see see
<nor- <nor-
mal>< OFD, mal><
Occipital Frontal Diameter OFD super- OFD_WEK, super- Ob Fet 1
script OFD_SD script
>a<no >b<no
rmal> rmal>
see see
<nor- <nor-
mal>< HC, mal><
Head Circumference HC super- HC_WEK, super- Ob Fet 1
script HC_SD script
>a<no >b<no
rmal> rmal>

7-104 SIGMA 110/SIGMA 330 15.10.01

 Description SIGMA SonoWin® Chapter
see see
<nor- <nor-
mal>< ATD, mal><
Transabdominal Diameter TAD super- ATD_WEK, super- Ob Fet 1
script ATD_SD script
>a<no >b<no
rmal> rmal>
see see
<nor- <nor-
mal>< ALD, mal><
Anterior Posterior Diameter APD super- ALD_WEK, super- Ob Fet 1
script ALS_SD script
>a<no >b<no
rmal> rmal>
see see
<nor- <nor-
mal>< AC, mal><
Abdominal Circumference AC super- AC_WEK, super- Ob Fet 1
script AC_SD script
>a<no >b<no
rmal> rmal>
see see
<nor- <nor-
mal>< THD, mal><
Thoracic Diameter THD super- THD_WEK, super- Ob Fet 1
script THD_SD script
>a<no >b<no
rmal> rmal>
see see
<nor- <nor-
mal>< FL, mal><
Femur Length FML super- FL_WEK, super- Ob Fet 1
script FL_SD script
>a<no >b<no
rmal> rmal>
see see
<nor- <nor-
mal>< HUM, mal><
Humerus Length HuL super- HUM_WEK, super- Ob Fet 1
script HUM_SD script
>a<no >b<no
rmal> rmal>
see see
<nor- <nor-
mal>< AC, mal><
Computed Abdominal Circumference AC super- AC_WEK, super- Ob Fet 1
script AC_SD script
>a<no >b<no
rmal> rmal>
see see
<nor- <nor-
mal>< HC, mal><
Computed Head Circumference HC super- HC_WEK, super- Ob Fet 1
script HC_SD script
>a<no >b<no
rmal> rmal>
Cephalic Index (BPD/OFD) CI % CI % Ob Fet 1

15.10.01 APPENDICES 7-105

 Description SIGMA SonoWin® Chapter
Head Circumference / Abdominal Circum-
HC/AC % HC/AC % Ob Fet 1
ference
Femur Length / Abdominal Circumference FML/AC % FL/AC % Ob Fet 1
Femur Length / Biparietal Diameter FML/BPD % FL/BPD % Ob Fet 1
Foetal Weight in gramms WEIGHT g EFW g Ob Fet 1
Uncertainty in gramms +/- g EFW_SD g Ob Fet 1
weeks
Average Ultrasound Age AUA weeks USGA + Patient data
days
Average Estimated Birth Date AEBD date USDD date Patient data
a. This measure is defined on the SIGMA by a distance (in cm), an estimated fetal age (in weeks and days) and an uncertainty (in
weeks and days) on the fetal age
b. This measure is defined on SonoWin® by a distance (in mm), an estimated fetal age (in weeks and days) and an uncertainty (in
weeks and days) on the fetal age

K.4.2 SP measures

K.4.2.1 Heart Rate

Description SIGMA SonoWin® Chapter

Heart rate HR bpm HEART_R bpm Ob Fet 1

K.4.2.2 Velocity and Frequency measurement

Description SIGMA SonoWin® Chapter

Velocitya Velocity m/s - - -
Frequency<normal><super-
Frequency kHz - - -
script>a<normal>

a. This SIGMA measure is not assigned to a variable in SonoWin®. The user has to assign it manually to SonoWin®
parameter.

K.4.2.3 Resistance and Pulsatility Index

• Uterine Left Artery:

Description SIGMA SonoWin® Chapter
Pulsatility Index PI - PI-AUT-l - Ob Fet 1
• Mean Velocity TAMX m/s VTAMX-AUT-l cm/s Ob Fet 1
• Velocity at Systole Vels m/s Vsyst_AUT-l cm/s Ob Fet 1
• Velocity at Diastole Veld m/s Venddiast_AUT-l cm/s Ob Fet 1
• Ratio Velocity Systole/Diastole Vels/Veld - S/D_AUT-l - Ob Fet 1
Resistance Index RI - RI-AUT-l - Ob Fet 1
• Velocity at Systole Vels m/s Vsyst_AUT-l cm/s Ob Fet 1
• Velocity at Diastole Veld m/s Venddiast_AUT-l cm/s Ob Fet 1
• Ratio Velocity Systole/Diastole Vels/Veld - S/D_AUT-l - Ob Fet 1

7-106 SIGMA 110/SIGMA 330 15.10.01

 • Uterine Right Artery:
Description SIGMA SonoWin® Chapter
Pulsatility Index PI - PI-AUT-r - Ob Fet 1
• Mean Velocity TAMX m/s VTAMX-AUT-r cm/s Ob Fet 1
• Velocity at Systole Vels m/s Vsyst_AUT-r cm/s Ob Fet 1
• Velocity at Diastole Veld m/s Venddiast_AUT-r cm/s Ob Fet 1
• Ratio Velocity Systole/Diastole Vels/Veld - S/D_AUT-r - Ob Fet 1
Resistance Index RI - RI-AUT-r - Ob Fet 1
• Velocity at Systole Vels m/s Vsyst_AUT-r cm/s Ob Fet 1
• Velocity at Diastole Veld m/s Venddiast_AUT-r cm/s Ob Fet 1
• Ratio Velocity Systole/Diastole Vels/Veld - S/D_AUT-r - Ob Fet 1

• Umbilical Artery:
Description SIGMA SonoWin® Chapter
Pulsatility Index PI - PI-AUM - Ob Fet 1
• Mean Velocity TAMX m/s VTAMX-AUM cm/s Ob Fet 1
• Velocity at Systole Vels m/s Vsyst_AUM cm/s Ob Fet 1
• Velocity at Diastole Veld m/s Venddiast_AUM cm/s Ob Fet 1
• Ratio Velocity Systole/Diastole Vels/Veld - S/D_AUM - Ob Fet 1
Resistance Index RI - RI-AUM - Ob Fet 1
• Velocity at Systole Vels m/s Vsyst_AUM cm/s Ob Fet 1
• Velocity at Diastole Veld m/s Venddiast_AUM cm/s Ob Fet 1
• Ratio Velocity Systole/Diastole Vels/Veld - S/D_AUM - Ob Fet 1

• Cerebral Artery:
Description SIGMA SonoWin® Chapter
Pulsatility Index PI - PI-ACM - Ob Fet 1
• Mean Velocity TAMX m/s VTAMX-ACM cm/s Ob Fet 1
• Velocity at Systole Vels m/s Vsyst-ACM cm/s Ob Fet 1
• Velocity at Diastole Veld m/s Venddiast_ACM cm/s Ob Fet 1
• Ratio Velocity Systole/Diastole Vels/Veld - S/D_ACM - Ob Fet 1
Resistance Index RI - RI-ACM - Ob Fet 1
• Velocity at Systole Vels m/s Vsyst-ACM cm/s Ob Fet 1
• Velocity at Diastole Veld m/s Venddiast_ACM cm/s Ob Fet 1
• Ratio Velocity Systole/Diastole Vels/Veld - S/D_ACM - Ob Fet 1

15.10.01 APPENDICES 7-107

K.4.3 Foetal information

Description SIGMA SonoWin® Chapter

Number of pregnancies GRAVIDITAS - GRAV - Patient data
Number of birthes having reached time Term - TERM - Patient data
Number of premature birthes Prema - PREM - Patient data
Number of abortion Abortion - ABORT - Patient data
Number of alive infant at birth Living - LIV - Patient data
CARDIAC
Foetal Cardiac Activity - card_Act - Ob Fet 1
ACTIVITY
FOETAL MOVE-
Foetal Movement - MOVE - Ob Fet 1
MENT
FOETAL
Foetal Breathing - BREATH - Ob Fet 1
BREATHING
Foetal Gender GENDER - SEX - Ob Fet 1
PRESENTA-
Foetal Presentation - PRES - Ob Fet 1
TION

K.5 Radiology Study

K.5.1 Volumes In Abdo 2D Studies

Description SIGMA SonoWin® Chapter

Tumor1_L, Abdomen,
Tumor2_L, Abdomen,
Distance 1 d1 cm mm
Tumor1_L, Small Parts Mamma
Tumor2_L Small Parts Mamma
Tumor1_H, Abdomen,
Tumor2_H, Abdomen,
Distance 2 d2 cm mm
Tumor1_H, Small Parts Mamma
Tumor2_H Small Parts Mamma
Tumor1_W, Abdomen,
Tumor2_W, Abdomen,
Distance 3 d3 cm mm
Tumor1_W, Small Parts Mamma
Tumor2_W Small Parts Mamma
Tumor1_V, Abdomen,
Tumor2_V, Abdomen,
Volume V cm3 mm3
Tumor1_V, Small Parts Mamma
Tumor1_V Small Parts Mamma

K.5.2 Cardiac Outputs

Description SIGMA SonoWin® Chapter

Diameter of the vessel Diam cm DIAM mm Card D Mitral Valve

K.5.3 Continuity Equation

Description SIGMA SonoWin® Chapter

Diameter 1 Diam1 cm Diam mm Angio Doppler Auto Trace
Area 1 AREA1 cm2 AREA1 mm2 Angio Doppler Auto Trace

7-108 SIGMA 110/SIGMA 330 15.10.01

K.5.4 Hip Angles

Description SIGMA SonoWin® Chapter

Alpha angle Alpha angle degrees Alpha degrees Pediatrics
Type of the Alpha
Type of the Alpha angle - TypeForAlpha - Pediatrics
angle
Beta Angle Beta Angle degrees Beta degrees Pediatrics
Type of the Beta
Type of the Beta angle - TypeForBeta - Pediatrics
angle

K.6 Multiple associations

Sometimes, several SIGMA data are assigned to the same SonoWin® data. It is the user’s
responsibility to choose which one will be used.

SonoWin® Item SIGMA value Description

OG2DAC Abdominal circumference
AC
OG2DCAC Computed abdominal circumference
OG2DAC_SD Uncertainty on foetal age estimated from AC
AC_SD
OG2DCAC_SD Uncertainty on foetal age estimated from computed AC
OG2DAC_WEK Foetal age estimated from AC
AC_WEK
OG2DCAC_WEK Foetal age estimated from computed AC
AVOTCO_COI Cardiac index
CI
AVSPCO_COI Cardiac index
AVOTCO_CO Cardiac output
CO
AVSPCO_CO Cardiac output
ANCEQ_D Diameter for Continuity Equation
Diam
ANDIA Diameter for Continuity Equation
AV2DMVD Diameter
DIAM MVCE_D Diameter
MVD Diameter
OG2DCHC Head circumference
HC
OG2DHC Head circumference
OG2DCHC_SD Uncertainty on foetal age estimated from computed HC
HC_SD
OG2DHC_SD Uncertainty on foetal age estimated from HC
OG2DCHC_WEK Foetal age estimated from computed HC
HC_WEK
OG2DHC_WEK Foetal age estimated from HC
LVTMIVd_IVS Inter ventricular septum thickness at diastole
IVSTS
LVTMIVs_IVS Inter ventricular septum thickness at systole
AV2DMVA Mitral valve area
MVA
MVPHT_Area Mitral valve area computed from PHT
AVSPPEP Aortic valve pre ejection period (SP meas)
PEP
AVTMLPP Aortic valve pre ejection period (TM meas)
OGSPPIC_VelS/VelD Ratio syst./diast. velocity medial cerebral artery (computed on PI)
S/D_ACM
OGSPRIC_VelS/VelD Ratio syst./diast. velocity medial cerebral artery (computed on RI)

15.10.01 APPENDICES 7-109

 SonoWin® Item SIGMA value Description
OGSPPIU_VelS/VelD Ratio syst./diast. velocity umbilical artery (computed on PI)
S/D_AUM
OGSPRIU_VelS/VelD Ratio syst./diast. velocity umbilical artery (computed on RI)
OGSPPIL_VelS/VelD Ratio syst./diast. velocity uterine artery left (computed on PI)
S/D_AUT-l
OGSPRIL_VelS/VelD Ratio syst./diast. velocity uterine artery left (computed on PI)
OGSPPIR_VelS/VelD Ratio syst./diast. velocity uterine artery right (computed on PI)
S/D_AUT-r
OGSPRIR_VelS/VelD Ratio syst./diast. velocity uterine artery right (computed on RI)
AVOTSV_SI Stroke volume index computed on left ventricle output trunk
SI
AVSPSV_SI Stroke volume index computed on aortic valve
AVOTSV_SV Stroke volume computed on left ventricle output trunk
SV
AVSPSV_SV Stroke volume computed on aortic valve
OGSPPIC_VelD Enddiastolic velocity cerebral medial artery computed on PI
Venddiast_ACM
OGSPRIC_VelD Enddiastolic velocity cerebral medial artery computed on RI
OGSPPIU_VelD Enddiastolic velocity umbilical artery computed on PI
Venddiast_AUM
OGSPRIU_VelD Enddiastolic velocity umbilical artery computed on RI
OGSPPIL_VelD Enddiastolic velocity uterine artery left computed on PI
Venddiast_AUT-l
OGSPRIL_VelD Enddiastolic velocity uterine artery left computed on RI
OGSPPIR_VelD Enddiastolic velocity uterine artery right computed on PI
Venddiast_AUT-r
OGSPRIR_VelD Enddiastolic velocity uterine artery right computed on RI
MVCE_Vel1 Velocity from mitral valve continuity equation
Vpeak1
MVPHT_PKV Max velocity from mitral valve PHT
ANCEQ_Vel1 Velocity 1 from vascular continuity equation
VpeakS1
ANPI_Vels Max Velocity from vascular PI
ANCEQ_Vel2 Velocity 2 from vascular continuity equation
VpeakS2
ANRI_Vels Max Velocity from vascular RI
OGSPPIC_Vels Systolic velocity cerebri media artery (computed on PI)
Vsyst_ACM
OGSPRIC_Vels Systolic velocity cerebri media artery (computed on RI)
OGSPPIU_Vels Systolic velocity umbilical artery (computed on PI)
Vsyst_AUM
OGSPRIU_Vels Systolic velocity umbilical artery (computed on RI)
OGSPPIL_Vels Systolic velocity uterine artery left (computed on PI)
Vsyst_AUT-l
OGSPRIL_Vels Systolic velocity uterine artery left (computed on RI)
OGSPPIR_Vels Systolic velocity uterine artery right (computed on PI)
Vsyst_AUT-r
OGSPRIR_Vels Systolic velocity uterine artery right (computed on RI)
ANCEQ_VTI1 VTI1 from vascular continuity equation
ANSBI_MVI MVI from vascular spectral broadening index
VTI1
ANSI_VTI VTI from vascular stenosis index
ANVTI VTI from vascular cardiac output
ANBF_MVI MVI from vascular blood flow
VTI2 ANCEQ_VTI2 VTI2 from vascular continuity equation
ANSBI_VTI VTI from vascular spectral broadening index

7-110 SIGMA 110/SIGMA 330 15.10.01

Appendix L: Body Markers

L.1 Vascular
1 Neck (chin up) 10 Arm (right)

2 Neck left (head up) 11 Arm (left)

3 Neck right (head up) 12 Back

4 Body female 13 Head (face)

5 Body male 14 Head (left)

6 Body (right) 15 Head (right)

7 Body (left) 16 Neck

8 Leg (back) 17 Eye (right)

9 Leg (front) 18 Eye (left)

L.2 Radiology
Two sets of body markers are gathered under the radio application
• Abdominal body marker set

1 Body female 6 Breast

2 Body male 7 Neck (with chin up)

3 Back 8 Neck left (head up)

4 Body (right) 9 Neck right (head up)

5 Body (left) 10 Head (face)

• Paediatry body marker set

11 Body 12 Head

15.10.01 APPENDICES 7-111

L.3 Obstetrics/ Gynaecology
1 Body 7 Foetus

2 Body female 8 Foetus

3 Body pregnant 9 Foetus

4 Body pregnant (right) 10 Foetus (back)

5 Body pregnant (left) 11 Foetus (back)

6 Foetus

L.4 Cardiology
A set of 10 body markers is available in Cardiology. No scan direction is needed for this type of
body markers.

1 Parasternal long axis 6 Apical two chamber view

2 Mitral valve level 7 Subcostal four chamber view

3 Papillary muscle level 8 Parasternal short axis

4 High short axis 9 Subparasternal application parallel

Subparasternal application trans-

5 Apical four chamber view 10
verse

7-112 SIGMA 110/SIGMA 330 15.10.01

Appendix M: Acoustic Output Tables

M.1 Track3 Summary Tables

In the following tables, each transducer/mode combination for which the global maximum dis-
played MI and/or TI is greater than 1.0, is checked with a "÷". For these combinations, details are
given in the Acoustic Output Reporting Tables in section L.3.
Shaded fields are combinations which are not supported by SIGMA 110/330.

Table 7-1: Track 3 Summary Table: Possible Operating Modes

Mechanical Scanheads
Transducer Model
Operating modes
3.5 GP 5.0 GP 7.5 GP 6.5 EV 6.5 MR 14 PV
B-Mode
M-Mode
PW-Doppler √ √
CW-Doppler
Color Doppler
Combined
Other

Table 7-2: Track 3 Summary Table: Possible Operating Modes

Linear and Convex Probes
Transducer Model
Operating modes
3.5 CV 7.5 LV 7.5 LVS 6.5 VMC 3.5 MC 5.0 LV 6.5 MC
B-Mode √ √ √
M-Mode √ √ √
PW-Doppler √ √ √ √ √
CW-Doppler
Color Doppler √ √ √ √ √ √ √
Combined
Other

15.10.01 APPENDICES 7-113

 Table 7-3: Track 3 Summary Table: Possible Operating Modes
Doppler Probes
Transducer Model
Operating modes 2 MHz 2 MHz 4 MHz 8 MHz
TCD Pen Pen Pen
B-Mode
M-Mode
PW-Doppler √
CW-Doppler
Color Doppler
Combined
Other

M.2 Definition of Terms

For each transducer/mode combination checked with a "÷" in table 7-1 on page 7-113, table 7-2
on page 7-113 and table 7-3 on page 7-114 an output reporting table is given in Chapter M.3,
“Acoustic Output Tables”, on page 7-116.
The symbols used in the acoustic output tables are explained below:
MI mechanical index
TISscan soft tissue thermal index in auto-scanning mode
TISnon-scan soft tissue thermal index in non-autoscanning mode
TIB bone thermal index
TIC cranial thermal index
Aaprt area of active aperture
pr.3 derated rarefactional pressure
W0 ultrasonic power, in scanned modes ultrasonic power passing through a one
centimeter window
W.3(z) derated ultrasonic power at axial distance z
ITA.3(z) derated spatial-peak temporal-average intensity at axial distance z
z1 axial distance corresponding to the location of
max[min(W.3(z), ITA.3(z)x 1 cm2)]
zbp minimum axial distance for measurements (break point depth), 1.69 * sqrt(Aaprt)
zsp for MI: axial distance of maximum ITA.3
for TIB: axial distance of maximum ITA.6 = zB.3
deq(z) equivalent beam diameter at axial distance z, deq(z)= [(4/p) (W0 / ITA(z))]0.5
where ITA(z) is the temporal-average intensity as a function of z.
fc center frequency

7-114 SIGMA 110/SIGMA 330 15.10.01

Dim. of Aaprt active aperture dimensions for the azimuthal (x) and elevational (y) planes
PD pulse duration
PRF pulse repetition frequency
pr@PIImax peak rarefactional pressure where the spatial-peak pulse intensity integral is
maximum
deq@PIImax equivalent beam diameter at the point where the spatial-peak pulse intensity
integral is maximum
FL focal length
IPA.3@MImax derated pulse-average intensity at the point of maximum MI

15.10.01 APPENDICES 7-115

M.3 Acoustic Output Tables
The following tables show the detailed measurement results for transducer/mode combinations
which have a maximum thermal and/or mechanical index exceeding a value of 1.0:

Transducer Model: 3.5MHz GP Operating Mode: PW-mode

TIS TIB TIC
non-scan
Index Label MI non-
scan Aaprt Aaprt scan
<=1 >=1
Global Maximum Index value (a) - - < 1.0 2.3 (b)
pr.3 MPa #
Assoc. Acoustic Parameters

W0 mW - - 96.7 #
min of [W.3(z1), ITA.3(z1)] mW #
z1 cm #
zbp cm #
zsp cm # 6.25
deq(zsp) cm 0.42
fc MHz # - - # 3.07 #
x cm - - # 1.6 #
Dim. of Aaprt
y cm - - # 1.6 #
PD msec # - - # 10.0 #
Other Information

PRF Hz #
pr@PIImax MPa #
deq@PIImax cm 0.42
FLx cm - - # #
Focal Length
FLy cm - - # #
IPA.3@MImax W/cm 2 #
application # - - # Vasc. #
Doppler frequency MHz # - - # 3 #
Control

gate size mm # - - # 8 #
velocity range kHz # - - # 3.2 #
energy dB # - - # 0 #

Notes:
(a) This index is not required for this operating mode; see section 4.1.3.1 of the Output
Display Standard (NEMA-UD-3).
(b) This probe is not intended for transcranial or neonatal cephalic uses.
(c) This formulation for TIS is less than that for an alternate formulation in this mode.
# No data are reported for this operating condition since the global maximum index value
is
not reported for the reason listed.

7-116 SIGMA 110/SIGMA 330 15.10.01

 Transducer Model: 5.0 MHz GP Operating Mode: PW-mode
TIS TIB TIC
non-scan
Index Label MI non-
scan Aaprt Aaprt scan
<=1 >=1
Global Maximum Index value (a) - - < 1.0 1.6 (b)
pr.3 MPa #
Assoc. Acoustic Parameters

W0 mW - - 32.2 #
min of [W.3(z1), ITA.3(z1)] mW #
z1 cm #
zbp cm #
zsp cm # 3.29
deq(zsp) cm 0.22
fc MHz # - - # 4.10 #
x cm - - # 1.14 #
Dim. of Aaprt
y cm - - # 1.14 #
PD msec # - - # 10.1 #
Other Information

PRF Hz #
pr@PIImax MPa #
deq@PIImax cm 0.21
FLx cm - - # #
Focal Length
FLy cm - - # #
IPA.3@MImax W/cm 2 #
application # - - # Vasc. #
Doppler frequency MHz # - - # 4 #
Control

gate size mm # - - # 8 #
velocity range kHz # - - # 3.2 #
energy dB # - - # 0 #

Notes:
(a) This index is not required for this operating mode; see section 4.1.3.1 of the Output
Display Standard (NEMA-UD-3).
(b) This probe is not intended for transcranial or neonatal cephalic uses.
(c) This formulation for TIS is less than that for an alternate formulation in this mode.
# No data are reported for this operating condition since the global maximum index value
is
not reported for the reason listed.

15.10.01 APPENDICES 7-117

 Transducer Model: 7.5 MHz LV Operating Mode: PW-mode
TIS TIB TIC
non-scan
Index Label MI non-
scan Aaprt Aaprt scan
<=1 >=1
Global Maximum Index value (a) - 1.9 - 1.4 (b)
pr.3 MPa #
Assoc. Acoustic Parameters

W0 mW - - 38.3 #
min of [W.3(z1), ITA.3(z1)] mW 21.0
z1 cm 1.07
zbp cm 1.07
zsp cm # 1.96
deq(zsp) cm 0.31
fc MHz # - 8.19 - 8.19 #
x cm - 0.88 - 0.88 #
Dim. of Aaprt
y cm - 0.45 - 0.45 #
PD msec # - 10.5 - 10.5 #
Other Information

PRF Hz #
pr@PIImax MPa #
deq@PIImax cm 0.30
FLx cm - 2.06 - #
Focal Length
FLy cm - 2.06 - #
IPA.3@MImax W/cm 2 #
application # - Vasc. - Vasc. #
Doppler frequency MHz # - 8 - 8 #
Control

gate size mm # - 8 - 8 #
velocity range kHz # - 3.2 - 3.2 #
energy dB # - 0 - 0 #

Notes:
(a) This index is not required for this operating mode; see section 4.1.3.1 of the Output
Display Standard (NEMA-UD-3).
(b) This probe is not intended for transcranial or neonatal cephalic uses.
(c) This formulation for TIS is less than that for an alternate formulation in this mode.
# No data are reported for this operating condition since the global maximum index value
is
not reported for the reason listed.

7-118 SIGMA 110/SIGMA 330 15.10.01

 Transducer Model: 7.5 MHz LVS Operating Mode: PW-mode
TIS TIB TIC
non-scan
Index Label MI non-
scan Aaprt Aaprt scan
<=1 >=1
Global Maximum Index value (a) - 1.7 - 1.0 (b)
pr.3 MPa #
Assoc. Acoustic Parameters

W0 mW - - 33.7 #
min of [W.3(z1), ITA.3(z1)] mW 17.0
z1 cm 1.20
zbp cm 1.20
zsp cm # 2.23
deq(zsp) cm 0.30
fc MHz # - 819 - 8.19 #
x cm - 0.77 - 0.77 #
Dim. of Aaprt
y cm - 0.65 - 0.65 #
PD msec # 10.5 - 10.5 #
Other Information

PRF Hz #
pr@PIImax MPa #
deq@PIImax cm 0.29
FLx cm - 2.34 - #
Focal Length
FLy cm - 2.34 - #
IPA.3@MImax W/cm 2 #
application # - Vasc. - Vasc. #
Doppler frequency MHz # - 8 - 8 #
Control

gate size mm # - 8 - 8 #
velocity range kHz # - 3.2 - 3.2 #
energy dB # - 0 - 0 #

Notes:
(a) This index is not required for this operating mode; see section 4.1.3.1 of the Output
Display Standard (NEMA-UD-3).
(b) This probe is not intended for transcranial or neonatal cephalic uses.
(c) This formulation for TIS is less than that for an alternate formulation in this mode.
# No data are reported for this operating condition since the global maximum index value
is
not reported for the reason listed.

15.10.01 APPENDICES 7-119

 Transducer Model: 2 MHz TCD Operating Mode: PW-mode
TIS TIB TIC
non-scan
Index Label MI non-
scan Aaprt Aaprt scan
<=1 >=1
Global Maximum Index value (a) - - < 1.0 2.6 2.8
pr.3 MPa #
Assoc. Acoustic Parameters

W0 mW - - 69.0 69.0
min of [W.3(z1), ITA.3(z1)] mW -
z1 cm -
zbp cm -
zsp cm # 3.85
deq(zsp) cm 0.35
fc MHz # - - - 2.04 2.04
x cm - - - 1.5 1.5
Dim. of Aaprt
y cm - - - 1.5 1.5
PD msec # - - - 10.0 10.0
Other Information

PRF Hz #
pr@PIImax MPa #
deq@PIImax cm 0.34
FLx cm - - - 4.20
Focal Length
FLy cm - - - 4.20
IPA.3@MImax W/cm 2 #
application # - - - Vasc. Vasc.
Doppler frequency MHz # - - - 2 2
Control

gate size mm # - - - 8 8
velocity range kHz # - - - 3.2 3.2
energy dB # - - - 0 0

Notes:
(a) This index is not required for this operating mode; see section 4.1.3.1 of the Output
Display Standard (NEMA-UD-3).
(b) This probe is not intended for transcranial or neonatal cephalic uses.
(c) This formulation for TIS is less than that for an alternate formulation in this mode.
# No data are reported for this operating condition since the global maximum index value
is
not reported for the reason listed.

7-120 SIGMA 110/SIGMA 330 15.10.01

 Transducer Model: 3.5 MHz CV Operating Mode: Color Flow Doppler
TIS TIB TIC
non-scan
Index Label MI non-
scan Aaprt Aaprt scan
<=1 >=1
Global Maximum Index value (a) 1.1 - - - (b)
pr.3 MPa #
Assoc. Acoustic Parameters

W01 mW 63.8 - - #
min of [W.3(z1), ITA.3(z1)] mW -
z1 cm -
zbp cm -
zsp cm # -
deq(zsp) cm -
fc MHz # 3.1 - - - #
x cm 1.28 - - - #
Dim. of Aaprt
y cm 1.20 - - - #
PD msec # 3.90
Other Information

PRF Hz #
pr@PIImax MPa #
deq@PIImax cm -
FLx cm 6.40 - - #
Focal Length
FLy cm 6.40 - - #
IPA.3@MImax W/cm 2 #
depth cm # 15 - - - #
Doppler frequency MHz # 3.10 - - - #
color depth # min. - - - #
color angle # min. - - - #
Control

resolution # med - - - #
wall filter # off - - - #
energy # 0 dB - - - #
application # Vasc. - - - #
velocity range Hz # 250 - - - #
steering angle degrees # 0 - - - #

Notes:
(a) This index is not required for this operating mode; see section 4.1.3.1 of the Output
Display Standard (NEMA-UD-3).
(b) This probe is not intended for transcranial or neonatal cephalic uses.
(c) This formulation for TIS is less than that for an alternate formulation in this mode.
# No data are reported for this operating condition since the global maximum index value
is
not reported for the reason listed.

15.10.01 APPENDICES 7-121

 Transducer Model: 7.5 MHz LV Operating Mode: Color Flow Doppler
TIS TIB TIC
non-scan
Index Label MI non-
scan Aaprt Aaprt scan
<=1 >=1
Global Maximum Index value (a) 1.6 - - - (b)
pr.3 MPa #
Assoc. Acoustic Parameters

W01 mW 43.6 - - #
min of [W.3(z1), ITA.3(z1)] mW -
z1 cm -
zbp cm -
zsp cm # -
deq(zsp) cm -
fc MHz # 6.13 - - - #
x cm 0.88 - - - #
Dim. of Aaprt
y cm 0.45 - - - #
PD msec # 1.40 - - - -
Other Information

PRF Hz #
pr@PIImax MPa #
deq@PIImax cm -
FLx cm 2.07 - - #
Focal Length
FLy cm 2.07 - - #
IPA.3@MImax W/cm 2 #
depth cm # 4 - - - #
Doppler frequency MHz # 6.1 - - - #
color depth # min. - - - #
color angle # min. - - - #
Control

resolution # med - - - #
wall filter # off - - - #
energy # 0 dB - - - #
application # Vasc. - - - #
velocity range kHz # 250 - - - #
steering angle degrees # 0 - - - #

Notes:
(a) This index is not required for this operating mode; see section 4.1.3.1 of the Output
Display Standard (NEMA-UD-3).
(b) This probe is not intended for transcranial or neonatal cephalic uses.
(c) This formulation for TIS is less than that for an alternate formulation in this mode.
# No data are reported for this operating condition since the global maximum index value
is
not reported for the reason listed.

7-122 SIGMA 110/SIGMA 330 15.10.01

 Transducer Model: 7.5 MHz LVS Operating Mode: Color Flow Doppler
TIS TIB TIC
non-scan
Index Label MI non-
scan Aaprt Aaprt scan
<=1 >=1
Global Maximum Index value (a) 1.8 - - - (b)
pr.3 MPa #
Assoc. Acoustic Parameters

W01 mW 49.1 - - #
min of [W.3(z1), ITA.3(z1)] mW -
z1 cm -
zbp cm -
zsp cm # -
deq(zsp) cm -
fc MHz # 6.13 - - - #
x cm 0.77 - - - #
Dim. of Aaprt
y cm 0.65 - - - #
PD msec # 1.40
Other Information

PRF Hz #
pr@PIImax MPa #
deq@PIImax cm -
FLx cm 2.30 - - #
Focal Length
FLy cm 2.30 - - #
IPA.3@MImax W/cm 2 #
depth cm # 3 - - - #
Doppler frequency MHz # 6.1 - - - #
color depth # min. - - - #
color angle # min. - - - #
Control

resolution # med - - - #
wall filter # off - - - #
energy # 0 dB - - - #
application # Vasc. - - - #
velocity range kHz # 250 - - - #
steering angle degrees # 0 - - - #

Notes:
(a) This index is not required for this operating mode; see section 4.1.3.1 of the Output
Display Standard (NEMA-UD-3).
(b) This probe is not intended for transcranial or neonatal cephalic uses.
(c) This formulation for TIS is less than that for an alternate formulation in this mode.
# No data are reported for this operating condition since the global maximum index value
is
not reported for the reason listed.

15.10.01 APPENDICES 7-123

 Transducer Model: 6.5 MHz VMC Operating Mode: Color Flow Doppler
TIS TIB TIC
non-scan
Index Label MI non-
scan Aaprt Aaprt scan
<=1 >=1
Global Maximum Index value (a) 1.5 - - - (b)
pr.3 MPa #
Assoc. Acoustic Parameters

W01 mW 43.6 - - #
min of [W.3(z1), ITA.3(z1)] mW -
z1 cm -
zbp cm -
zsp cm # -
deq(zsp) cm -
fc MHz # 6.13 - - - #
x cm 0.67 - - - #
Dim. of Aaprt
y cm 0.65 - - - #
PD msec # 1.40
Other Information

PRF Hz #
pr@PIImax MPa #
deq@PIImax cm -
FLx cm 4.06 - - #
Focal Length
FLy cm 4.06 - - #
IPA.3@MImax W/cm 2 #
depth cm # 6 - - - #
Doppler frequency MHz # 6.1 - - - #
color depth # min. - - - #
color angle # min. - - - #
Control

resolution # med - - - #
wall filter # off - - - #
energy # 0 dB - - - #
application # ObGyn - - - #
velocity range kHz # 250 - - - #
steering angle degrees # 0 - - - #

Notes:
(a) This index is not required for this operating mode; see section 4.1.3.1 of the Output
Display Standard (NEMA-UD-3).
(b) This probe is not intended for transcranial or neonatal cephalic uses.
(c) This formulation for TIS is less than that for an alternate formulation in this mode.
# No data are reported for this operating condition since the global maximum index value
is
not reported for the reason listed.

7-124 SIGMA 110/SIGMA 330 15.10.01

 Transducer Model: 3.5 MC Operating Mode: B-mode
TIS TIB TIC
non-scan
Index Label MI non-
scan Aaprt Aaprt scan
<=1 >=1
Global Maximum Index value 1.8 (a) - - - (a)
pr.3 MPa 2.7
Assoc. Acoustic Parameters

W0 mW # - - #
min of [W.3(z1), ITA.3(z1)] mW -
z1 cm -
zbp cm -
zsp cm 3.46 -
deq(zsp) cm -
fc MHz 2.40 # - - - #
Dim. of Aaprt x cm # - - - #
y cm # - - - #
PD msec 0.84
Other Information

PRF Hz 1000
pr@PIImax MPa 3.5
deq@PIImax cm -
Focal Length FLx cm # - - #
FLy cm # - - #
IPA.3@MImax W/cm 2 354.2
depth cm 24 # - - - #
Control

frequency f+ / f- f- # - - - #
angle ° 75 # - - - #
focus cm 3 # - - - #

Notes:
(a) This index is not required for this operating mode; see section 4.1.3.1 of the Output
Display Standard (NEMA-UD-3).
(b) This probe is not intended for transcranial or neonatal cephalic uses.
(c) This formulation for TIS is less than that for an alternate formulation in this mode.
# No data are reported for this operating condition since the global maximum index value
is
not reported for the reason listed.

15.10.01 APPENDICES 7-125

 Transducer Model: 3.5 MC Operating Mode: M-mode
TIS TIB TIC
non-scan
Index Label MI non-
scan Aaprt Aaprt scan
<=1 >=1
Global Maximum Index value (a) - - <1.0 1.7 (b)
pr.3 MPa #
Assoc. Acoustic Parameters

W0 mW - - 39.4 #
min of [W.3(z1), ITA.3(z1)] mW #
z1 cm #
zbp cm #
zsp cm # 3.62
deq(zsp) cm 0.33
fc MHz # - - # 2.40 #
x cm - - # 1.09 #
Dim. of Aaprt
y cm - - # 1.20 #
PD msec # # 0.84 #
Other Information

PRF Hz #
pr@PIImax MPa #
deq@PIImax cm 0.33
FLx cm - - # #
Focal Length
FLy cm - - # #
IPA.3@MImax W/cm 2 #
depth cm # - - # 24 #
frequency f+ / f- # - - # f- #
Control

focus cm # - - # 3 #

Notes:
(a) This index is not required for this operating mode; see section 4.1.3.1 of the Output
Display Standard (NEMA-UD-3).
(b) This probe is not intended for transcranial or neonatal cephalic uses.
(c) This formulation for TIS is less than that for an alternate formulation in this mode.
# No data are reported for this operating condition since the global maximum index value
is
not reported for the reason listed.

7-126 SIGMA 110/SIGMA 330 15.10.01

 Transducer Model: 3.5 MC Operating Mode: PW-mode
TIS TIB TIC
non-scan
Index Label MI non-
scan Aaprt Aaprt scan
<=1 >=1
Global Maximum Index value (a) - - <1.0 3.2 (b)
pr.3 MPa #
Assoc. Acoustic Parameters

W0 mW - - 93.5 #
min of [W.3(z1), ITA.3(z1)] mW #
z1 cm #
zbp cm #
zsp cm # 3.82
deq(zsp) cm 0.40
fc MHz # - - # 2.05 #
x cm - - # 1.09 #
Dim. of Aaprt
y cm - - # 1.2 #
PD msec # # 10.08 #
Other Information

PRF Hz #
pr@PIImax MPa #
deq@PIImax cm 0.40
FLx cm - - # #
Focal Length
FLy cm - - # #
IPA.3@MImax W/cm 2 #
application # - - # Vasc. #
Doppler frequency MHz # - - # 2 #
Control

gate size mm # - - # 8 #
velocity range kHz # - - # 3.2 #
energy dB # - - # 0 #

Notes:
(a) This index is not required for this operating mode; see section 4.1.3.1 of the Output
Display Standard (NEMA-UD-3).
(b) This probe is not intended for transcranial or neonatal cephalic uses.
(c) This formulation for TIS is less than that for an alternate formulation in this mode.
# No data are reported for this operating condition since the global maximum index value
is
not reported for the reason listed.

15.10.01 APPENDICES 7-127

 Transducer Model: 3.5 MC Operating Mode: Color Flow Doppler
TIS TIB TIC
non-scan
Index Label MI non-
scan Aaprt Aaprt scan
<=1 >=1
Global Maximum Index value (a) 1.5 - - - (b)
pr.3 MPa #
Assoc. Acoustic Parameters

W01 mW 100.3 - - #
min of [W.3(z1), ITA.3(z1)] mW -
z1 cm -
zbp cm -
zsp cm # -
deq(zsp) cm -
fc MHz # 3.05 - - - #
x cm 1.09 - - - #
Dim. of Aaprt
y cm 1.20 - - - #
PD msec # 2.95
Other Information

PRF Hz #
pr@PIImax MPa #
deq@PIImax cm -
FLx cm 5.08 - - #
Focal Length
FLy cm 5.08 - - #
IPA.3@MImax W/cm 2 #
depth cm # 5 - - - #
Doppler frequency MHz # 3.1 - - - #
color depth # min. - - - #
color angle # min. - - - #
Control

resolution # hi - - - #
wall filter # max. - - - #
energy dB # 0 - - - #
application # Vasc. - - - #
velocity range Hz # 250 - - - #
steering angle degrees # 0 - - - #

Notes:
(a) This index is not required for this operating mode; see section 4.1.3.1 of the Output
Display Standard (NEMA-UD-3).
(b) This probe is not intended for transcranial or neonatal cephalic uses.
(c) This formulation for TIS is less than that for an alternate formulation in this mode.
# No data are reported for this operating condition since the global maximum index value
is
not reported for the reason listed.

7-128 SIGMA 110/SIGMA 330 15.10.01

 Transducer Model: 5.0 LV Operating Mode: B-mode
TIS TIB TIC
non-scan
Index Label MI non-
scan Aaprt Aaprt scan
<=1 >=1
Global Maximum Index value 1.5 (a) - - - (a)
pr.3 MPa 2.9
Assoc. Acoustic Parameters

W0 mW # - - #
min of [W.3(z1), ITA.3(z1)] mW -
z1 cm -
zbp cm -
zsp cm 3.11 -
deq(zsp) cm -
fc MHz 3.88 # - - - #
Dim. of Aaprt x cm # - - - #
y cm # - - - #
PD msec 0.54
Other Information

PRF Hz 1000
pr@PIImax MPa 4.2
deq@PIImax cm -
Focal Length FLx cm # - - #
FLy cm # - - #
IPA.3@MImax W/cm 2 342.4
depth cm 15 # - - - #
Control

frequency f+ / f- f+ # - - - #
angle ° 75 # - - - #
focus cm 3 # - - - #

Notes:
(a) This index is not required for this operating mode; see section 4.1.3.1 of the Output
Display Standard (NEMA-UD-3).
(b) This probe is not intended for transcranial or neonatal cephalic uses.
(c) This formulation for TIS is less than that for an alternate formulation in this mode.
# No data are reported for this operating condition since the global maximum index value
is
not reported for the reason listed.

15.10.01 APPENDICES 7-129

 Transducer Model: 5.0 LV Operating Mode: M-mode
TIS TIB TIC
non-scan
Index Label MI non-
scan Aaprt Aaprt scan
<=1 >=1
Global Maximum Index value (a) - - <1.0 <1.0 (b)
pr.3 MPa #
Assoc. Acoustic Parameters

W0 mW - - # #
min of [W.3(z1), ITA.3(z1)] mW #
z1 cm #
zbp cm #
zsp cm # #
deq(zsp) cm #
fc MHz # - - # # #
x cm - - # # #
Dim. of Aaprt
y cm - - # # #
PD msec # - - # # #
Other Information

PRF Hz #
pr@PIImax MPa #
deq@PIImax cm #
FLx cm - - # #
Focal Length
FLy cm - - # #
IPA.3@MImax W/cm 2 #
depth # - - # # #
frequency # - - # # #
Control

focus # - - # # #
# - - # # #
# - - # # #

Notes:
(a) This index is not required for this operating mode; see section 4.1.3.1 of the Output
Display Standard (NEMA-UD-3).
(b) This probe is not intended for transcranial or neonatal cephalic uses.
(c) This formulation for TIS is less than that for an alternate formulation in this mode.
# No data are reported for this operating condition since the global maximum index value
is
not reported for the reason listed.

7-130 SIGMA 110/SIGMA 330 15.10.01

 Transducer Model: 5.0 LV Operating Mode: PW-mode
TIS TIB TIC
non-scan
Index Label MI non-
scan Aaprt Aaprt scan
<=1 >=1
Global Maximum Index value (a) - - 1.7 3.2 (b)
pr.3 MPa #
Assoc. Acoustic Parameters

W0 mW - - 142.1 #
min of [W.3(z1), ITA.3(z1)] mW 85.0
z1 cm 1.82
zbp cm 1.82
zsp cm # 3.54
deq(zsp) cm 0.38
fc MHz # - - 4.10 4.10 #
x cm - - 1.28 1.28 #
Dim. of Aaprt
y cm - - 0.90 0.90 #
PD msec # 10.22 10.22 #
Other Information

PRF Hz #
pr@PIImax MPa #
deq@PIImax cm 0.37
FLx cm - - 3.95 #
Focal Length
FLy cm - - 3.95 #
IPA.3@MImax W/cm 2 #
application # - - Vasc. Vasc. #
Doppler frequency MHz # - - 4 4 #
Control

gate size mm # - - 8 8 #
velocity range kHz # - - 3.2 3.2 #
energy dB # - - 0 0 #

Notes:
(a) This index is not required for this operating mode; see section 4.1.3.1 of the Output
Display Standard (NEMA-UD-3).
(b) This probe is not intended for transcranial or neonatal cephalic uses.
(c) This formulation for TIS is less than that for an alternate formulation in this mode.
# No data are reported for this operating condition since the global maximum index value
is
not reported for the reason listed.

15.10.01 APPENDICES 7-131

 Transducer Model: 5.0 LV Operating Mode: Color Flow Doppler
TIS TIB TIC
non-scan
Index Label MI non-
scan Aaprt Aaprt scan
<=1 >=1
Global Maximum Index value (a) 2.0 - - - (b)
pr.3 MPa #
Assoc. Acoustic Parameters

W01 mW 87.5 - - #
min of [W.3(z1), ITA.3(z1)] mW -
z1 cm -
zbp cm -
zsp cm # -
deq(zsp) cm -
fc MHz # 4.88 - - - #
x cm 1.28 - - - #
Dim. of Aaprt
y cm 0.90 - - - #
PD msec # 1.99
Other Information

PRF Hz #
pr@PIImax MPa #
deq@PIImax cm -
FLx cm 3.6 - - #
Focal Length
FLy cm 3.6 - - #
IPA.3@MImax W/cm 2 #
depth cm # 3 - - - #
Doppler frequency MHz # 4.9 - - - #
color depth # min. - - - #
color angle # min. - - - #
Control

resolution # med - - - #
wall filter # max. - - - #
energy dB # 0 - - - #
Periph.
application # Vessel
- - - #
velocity range Hz # 250 - - - #
steering angle degrees # 0 - - - #

Notes:
(a) This index is not required for this operating mode; see section 4.1.3.1 of the Output
Display Standard (NEMA-UD-3).
(b) This probe is not intended for transcranial or neonatal cephalic uses.
(c) This formulation for TIS is less than that for an alternate formulation in this mode.
# No data are reported for this operating condition since the global maximum index value
is
not reported for the reason listed.

7-132 SIGMA 110/SIGMA 330 15.10.01

 Transducer Model: 6.5 MC Operating Mode: B-mode
TIS TIB TIC
non-scan
Index Label MI non-
scan Aaprt Aaprt scan
<=1 >=1
Global Maximum Index value 1.5 (a) - - - (a)
pr.3 MPa 3.0
Assoc. Acoustic Parameters

W0 mW # - - #
min of [W.3(z1), ITA.3(z1)] mW -
z1 cm -
zbp cm -
zsp cm 2.00 -
deq(zsp) cm -
fc MHz 4.07 # - - - #
Dim. of Aaprt x cm # - - - #
y cm # - - - #
PD msec 0.54
Other Information

PRF Hz 1000
pr@PIImax MPa 4.0
deq@PIImax cm -
Focal Length FLx cm # - - #
FLy cm # - - #
IPA.3@MImax W/cm 2 312.6
depth cm 10 # - - - #
Control

frequency f+ / f- f- # - - - #
angle ° 75 # - - - #
focus cm 3 # - - - #

Notes:
(a) This index is not required for this operating mode; see section 4.1.3.1 of the Output
Display Standard (NEMA-UD-3).
(b) This probe is not intended for transcranial or neonatal cephalic uses.
(c) This formulation for TIS is less than that for an alternate formulation in this mode.
# No data are reported for this operating condition since the global maximum index value
is
not reported for the reason listed.

15.10.01 APPENDICES 7-133

 Transducer Model: 6.5 MC Operating Mode: M-mode
TIS TIB TIC
non-scan
Index Label MI non-
scan Aaprt Aaprt scan
<=1 >=1
Global Maximum Index value (a) - - <1.0 <1.0 (b)
pr.3 MPa #
Assoc. Acoustic Parameters

W0 mW - - # #
min of [W.3(z1), ITA.3(z1)] mW #
z1 cm #
zbp cm #
zsp cm # #
deq(zsp) cm #
fc MHz # - - # # #
x cm - - # # #
Dim. of Aaprt
y cm - - # # #
PD msec # - - # # #
Other Information

PRF Hz #
pr@PIImax MPa #
deq@PIImax cm #
FLx cm - - # #
Focal Length
FLy cm - - # #
IPA.3@MImax W/cm 2 #
depth # - - # # #
frequency # - - # # #
Control

focus # - - # # #
# - - # # #
# - - # # #

Notes:
(a) This index is not required for this operating mode; see section 4.1.3.1 of the Output
Display Standard (NEMA-UD-3).
(b) This probe is not intended for transcranial or neonatal cephalic uses.
(c) This formulation for TIS is less than that for an alternate formulation in this mode.
# No data are reported for this operating condition since the global maximum index value
is
not reported for the reason listed.

7-134 SIGMA 110/SIGMA 330 15.10.01

 Transducer Model: 6.5 MC Operating Mode: PW-mode
TIS TIB TIC
non-scan
Index Label MI non-
scan Aaprt Aaprt scan
<=1 >=1
Global Maximum Index value (a) - 2.5 - 4.0 (b)
pr.3 MPa #
Assoc. Acoustic Parameters

W0 mW - - 127.4 #
min of [W.3(z1), ITA.3(z1)] mW 92.8
z1 cm 1.12
zbp cm 1.12
zsp cm # 2.55
deq(zsp) cm 0.37
fc MHz # - 4.10 - 4.10 #
x cm - 0.67 - 0.67 #
Dim. of Aaprt
y cm - 0.65 - 0.65 #
PD msec # - 10.08 - 10.08 #
Other Information

PRF Hz #
pr@PIImax MPa #
deq@PIImax cm 0.35
FLx cm - - 3.07 #
Focal Length
FLy cm - - 3.07 #
IPA.3@MImax W/cm 2 #
application # - - Vasc. Vasc. #
Doppler frequency MHz # - - 4 4 #
Control

gate size mm # - - 8 8 #
velocity range kHz # - - 3.2 3.2 #
energy dB # - - 0 0 #

Notes:
(a) This index is not required for this operating mode; see section 4.1.3.1 of the Output
Display Standard (NEMA-UD-3).
(b) This probe is not intended for transcranial or neonatal cephalic uses.
(c) This formulation for TIS is less than that for an alternate formulation in this mode.
# No data are reported for this operating condition since the global maximum index value
is
not reported for the reason listed.

15.10.01 APPENDICES 7-135

 Transducer Model: 6.5 MC Operating Mode: Color Flow Doppler
TIS TIB TIC
non-scan
Index Label MI non-
scan Aaprt Aaprt scan
<=1 >=1
Global Maximum Index value (a) 2.5 - - - (b)
pr.3 MPa #
Assoc. Acoustic Parameters

W01 mW 87.1 - - #
min of [W.3(z1), ITA.3(z1)] mW -
z1 cm -
zbp cm -
zsp cm # -
deq(zsp) cm -
fc MHz # 6.1 - - - #
x cm 0.67 - - - #
Dim. of Aaprt
y cm 0.65 - - - #
PD msec # 1.43
Other Information

PRF Hz #
pr@PIImax MPa #
deq@PIImax cm -
FLx cm 3.64 - - #
Focal Length
FLy cm 3.64 - - #
IPA.3@MImax W/cm 2 #
depth cm # 2 - - - #
Doppler frequency MHz # 6.1 - - - #
color depth # min. - - - #
color angle # min. - - - #
Control

resolution # med - - - #
wall filter # max - - - #
energy dB # 0 - - - #
application # Carotid - - - #
velocity range Hz # 250 - - - #
steering angle degrees # 0 - - - #

Notes:
(a) This index is not required for this operating mode; see section 4.1.3.1 of the Output
Display Standard (NEMA-UD-3).
(b) This probe is not intended for transcranial or neonatal cephalic uses.
(c) This formulation for TIS is less than that for an alternate formulation in this mode.
# No data are reported for this operating condition since the global maximum index value
is
not reported for the reason listed.

7-136 SIGMA 110/SIGMA 330 15.10.01