Technical - Manual Clarity v5 PDF

Planmed Clarity ™
EN
technical manual
20009440_5
Table of contents
Chapter A: GENERAL & TECHNICAL DATA

1 INTRODUCTION ................................................................................................................. 7
1.1 Associated documentation .......................................................................................................... 7
1.2 How to find information in this manual ......................................................................................... 8
2 PLANMED CLARITY FFDM SYSTEM .................................................................................. 9
2.1 System setups ............................................................................................................................. 9
2.2 Mammography unit .................................................................................................................... 12
2.3 Characteristics of use ................................................................................................................ 13
3 WARNINGS AND PRECAUTIONS ..................................................................................... 15
4 SYMBOLS AND PRODUCT LABELS ................................................................................. 17
4.1 Symbols on product labels ........................................................................................................ 17
4.2 Product labels ............................................................................................................................ 18
5 SOFTWARE VERSIONS & COMPATIBILITY ..................................................................... 24
6 TECHNICAL SPECIFICATIONS ........................................................................................ 25
6.1 X-ray tube assembly .................................................................................................................. 26
6.2 Bucky grid .................................................................................................................................. 28
6.3 Automatic Exposure Control (AEC) ........................................................................................... 28
6.4 C-arm ......................................................................................................................................... 28
6.5 Mechanical data ........................................................................................................................ 29
6.6 Temperatures and humidity ....................................................................................................... 29
6.7 Dimensions ................................................................................................................................ 29
7 USER’S STATEMENT ....................................................................................................... 30
7.1 Definition of measurement criteria ............................................................................................. 30
7.2 X-ray tube ratings ...................................................................................................................... 32
7.3 Cooling curves for the X-ray tubes ............................................................................................ 33
8 AMORPHOUS SILICON (-Si) FLAT PANEL DETECTOR .................................................. 34
9 RADIATION SHIELD ......................................................................................................... 35
10 EMC INFORMATION ......................................................................................................... 36
11 LIST OF ABBREVIATIONS ................................................................................................ 40
Chapter B: CONTROL PANEL DISPLAYS

1 TOUCH SCREEN OVERVIEW ........................................................................................... 44
1.1 Common icons and buttons ....................................................................................................... 44
1.2 Information and About sheets .................................................................................................... 45
1.2.1 Information button ...................................................................................................... 45
1.2.2 Information sheet ....................................................................................................... 45
1.2.3 About sheet ................................................................................................................ 46
2 SERVICE & CONFIGURATION MENU ............................................................................... 47
2.1 Entering and exiting SERVICE & CONFIGURATION menu ..................................................... 48
2.1.1 To enter SERVICE & CONFIGURATION menu ......................................................... 48
2.1.2 To enter SERVICE & CONFIGURATION menu password protected views .............. 48
Technical manual Planmed Clarity 2D/3D 1

Table of contents
2.1.3 To exit SERVICE & CONFIGURATION menu ........................................................... 49

3 NOTIFICATION AND ERROR MESSAGES ........................................................................ 50
3.1 Mammography unit errors .......................................................................................................... 51
3.2 Mammography unit notifications ................................................................................................ 65
Chapter C: PREVENTIVE MAINTENANCE

1 SYSTEM MAINTENANCE ................................................................................................. 67
1.1 Cleaning ..................................................................................................................................... 67
1.2 Operator’s maintenance schedule ............................................................................................. 67
2 PREVENTIVE MAINTENANCE CHECKS ........................................................................... 69
2.1 Preventive maintenance schedule ............................................................................................. 69
2.2 Calibration and verification of the instruments ........................................................................... 69
2.3 Determining Half Value Layer (HVL / beam quality) .................................................................. 69
2.4 Checking X-ray tube radiation output ........................................................................................ 72
2.5 Image quality evaluation ............................................................................................................ 74
3 OTHER PREVENTIVE CHECKS ........................................................................................ 75
3.1 Verifying compression force measurement ............................................................................... 75
3.2 Verifying filament pre-heating voltages ...................................................................................... 75
3.3 Verifying anode voltage (kV) ...................................................................................................... 75
3.3.1 Measurement procedure using Mult-O-Meter ............................................................. 75
3.3.2 Measurement procedure using digital multimeter ....................................................... 76
3.4 Verifying tube current (mA) and exposure time ......................................................................... 77
3.5 Verifying X-ray beam alignment ................................................................................................. 79
3.6 Verifying light field beam illumination ......................................................................................... 79
3.7 Verifying light field alignment ..................................................................................................... 80
3.8 Measuring light field contrast ..................................................................................................... 80
3.9 Verifying electrical safety ........................................................................................................... 80
Chapter D: ADJUSTMENT & CALIBRATION

1 REGIONAL AND INITIAL SET-UPS BEFORE USING X-RAY UNIT ..................................... 81
2 ADVANCED ADJUSTMENTS ............................................................................................ 82
2.1 Calibrating compression force ................................................................................................... 82
2.2 Calibrating paddle offsets .......................................................................................................... 84
2.3 Calibrating movements .............................................................................................................. 88
2.3.1 Calibrating tilt .............................................................................................................. 88
2.3.2 Calibrating lift .............................................................................................................. 89
2.3.3 Calibrating rotation ..................................................................................................... 90
2.3.4 Calibrating compression ............................................................................................. 92
2.4 Calibration X-ray tube filament pre-heating voltage ................................................................... 93
2.5 Changing unit to and from transportation mode ........................................................................ 94
2.5.1 Changing unit to transportation mode ........................................................................ 94
2.5.2 Changing unit from transportation mode to operating mode ...................................... 95
2.6 Adjusting movement settings ..................................................................................................... 96
2.7 Adjusting exposure settings ....................................................................................................... 97
2.8 Updating maintenance information ............................................................................................ 98
2.9 Calibrating exposure radiation output ........................................................................................ 98
2.10 Adjusting diagnostic settings ..................................................................................................... 98
2.11 Adjusting acquisition settings ................................................................................................... 101
3 FULL FIELD FLEX AEC CALIBRATION PROCEDURE ..................................................... 103
4 2D CALIBRATIONS ........................................................................................................ 106
5 3D CALIBRATIONS ........................................................................................................ 106
2 Planmed Clarity 2D/3D Technical manual

Table of contents
6 CALIBRATING AND VERIFYING X-RAY FIELD SIZE ....................................................... 107

6.1 Calibrating X-ray field size ....................................................................................................... 108
6.2 Verifying X-ray field size .......................................................................................................... 110
6.2.1 Verifying X-ray field size for large focus ................................................................... 111
6.2.2 Verifying X-ray field size for tomosynthesis .............................................................. 117
6.3 Troubleshooting failed X-ray field verification .......................................................................... 122
6.3.1 If X-ray field verification fails ..................................................................................... 122
6.3.2 Manually adjust X-ray field size ................................................................................ 122
6.3.3 Acceptable X-ray field size ....................................................................................... 123
7 ADJUSTING LIGHT FIELD .............................................................................................. 124
7.1 Adjusting large focus and small light fields .............................................................................. 124
Chapter E: PARTS REPLACEMENT AND REPAIR

1 REMOVING COVERS ..................................................................................................... 130
1.1 Base covers ............................................................................................................................. 131
1.1.1 Removing side base covers ..................................................................................... 131
1.1.2 Removing rear base cover ....................................................................................... 131
1.2 Column covers ......................................................................................................................... 132
1.2.1 Removing hood ........................................................................................................ 132
1.2.2 Removing telescopic column back cover ................................................................. 133
1.2.3 Removing stationary column back cover .................................................................. 133
1.3 C-arm covers ........................................................................................................................... 134
1.3.1 Removing C-arm upper cover .................................................................................. 134
1.3.2 Removing C-arm back cover .................................................................................... 135
1.3.3 Removing C-arm lower cover ................................................................................... 136
2 UPDATING X-RAY UNIT SOFTWARE ............................................................................. 137
3 REPLACING MAIN FUSES .............................................................................................. 140
4 REPLACING BATTERIES & PCBs ................................................................................... 141
4.1 Replacing RTC PCB battery .................................................................................................... 141
5 REPLACING POWER CORD ........................................................................................... 144
6 REPLACING MECHANICAL PARTS ................................................................................ 146
6.1 Replacing gas spring ............................................................................................................... 146
6.2 Replacing detector ................................................................................................................... 147
6.3 Replacing lifting motor assembly ............................................................................................. 154
Chapter F: PLANMED CLARITY MANAGER

1 INSTALLING PLANMED CLARITY MANAGER ................................................................. 158
1.1 Computer settings ................................................................................................................... 158
1.1.1 Date and number format .......................................................................................... 158
1.1.2 Checking regional settings ....................................................................................... 158
1.1.3 Windows user accounts ........................................................................................... 158
1.1.4 Security settings ....................................................................................................... 158
1.1.5 Automatic updates ................................................................................................... 158
1.2 Installing Planmed Clarity Manager software .......................................................................... 159
1.3 Software uninstalling/reinstalling ............................................................................................. 160
1.4 Licensing Planmed Clarity Manager ........................................................................................ 160
1.5 Installing and activating 2D image processing licence ............................................................ 161
1.6 Configuring AWS ..................................................................................................................... 161
2 CONFIGURING PLANMED CLARITY MANAGER ............................................................. 162
2.1 SERVICE & CONFIGURATION menu .................................................................................... 162
2.1.1 Imaging / Device ...................................................................................................... 163

Table of contents
2.1.2 Imaging / Quality Control .......................................................................................... 164

2.1.3 Imaging / Calibration ................................................................................................. 165
2.1.4 Imaging / Enhancement ........................................................................................... 166
2.1.5 Imaging / AEC .......................................................................................................... 168
2.1.6 Imaging / Tomo ........................................................................................................ 170
2.1.7 Imaging / Clarity Guide ............................................................................................. 171
2.1.8 Imaging / DICOM ...................................................................................................... 172
2.1.9 Imaging / Display and Print ....................................................................................... 183
2.1.10 Clarity Guide ............................................................................................................. 184
2.1.11 Infra / Database ........................................................................................................ 185
2.1.12 Infra / Transfer .......................................................................................................... 187
2.1.13 Infra / Security .......................................................................................................... 188
2.1.14 Infra / Groups ........................................................................................................... 189
2.1.15 Infra / Users .............................................................................................................. 190
2.2 SUPPORT menu ..................................................................................................................... 192
3 PLANMED CLARITY FPD EMULATOR ............................................................................ 194
3.1 Using FPD emulator ................................................................................................................ 194
4 TROUBLESHOOTING ..................................................................................................... 195
5 LIST OF ABBREVIATIONS .............................................................................................. 196
Chapter G: PLANMED CLARITYGUIDE

1 TESTING AND CONFIGURING ....................................................................................... 198
1.1 Testing hand-held control box ................................................................................................. 198
1.2 Testing motor ........................................................................................................................... 199
1.3 Setting needle properties ......................................................................................................... 200
1.4 Configuring X correction .......................................................................................................... 201
2 CALIBRATING NEEDLE GUIDANCE UNIT ...................................................................... 202
2.1 Preparing X-ray unit for stereotactic biopsy ............................................................................. 202
2.2 Positioning X-ray unit ............................................................................................................... 202
2.3 Initiating calibration from Planmed Clarity Manager ................................................................ 203
2.4 Taking exposures .................................................................................................................... 204
2.5 Verifying calibration results and adjusting Z-correction parameter .......................................... 207
2.5.1 Preparing X-ray unit .................................................................................................. 207
2.5.2 Taking exposures ..................................................................................................... 208
2.5.3 Verifying positioning accuracy .................................................................................. 209
2.5.4 Marking targets on images ....................................................................................... 210
2.5.5 Adjusting Z-correction parameter ............................................................................. 212
2.5.6 Resetting X-ray unit from stereotactic biopsy ........................................................... 214
3 CALIBRATING MOTORIZED COMPRESSION ................................................................. 215
4 DETERMINING NEEDLE LENGTH AND SAFETY DISTANCE .......................................... 216
4.1 Determining needle length ....................................................................................................... 216
4.2 Determining safety distance .................................................................................................... 219
Chapter H: DIAGRAMS

Table of contents
The manufacturer, assembler and importer are responsible for the safety, reliability and
performance of the unit only if:
- installation, calibration, modification and repairs are carried out by qualified author-
ised personnel
- electrical installations are carried out according to the appropriate requirements such
as IEC 60364
- equipment is used according to the operating instructions.
Planmed pursues a policy of continual product development. Although every effort is

made to produce up-to-date product documentation this publication should not be re-
garded as an infallible guide to current specifications. We reserve the right to make
changes without prior notice.
COPYRIGHT PLANMED
Publication number 20009440 Revision 5
Released 13 February 2018

Table of contents

Chapter A: GENERAL & TECHNICAL
DATA
1 INTRODUCTION
This manual includes instructions for configuration, adjustment, calibration, and
maintenance of the Planmed mammography X-ray unit, as well as the Planmed Clarity
Manager software installed on the AWS computer.
This manual is intended for the technical support personnel only.
NOTE
Service and maintenance must always be performed by a qualified service technician.
This manual applies to both the Planmed Clarity 2D/3D Full Field Digital Mammography
(FFDM) and to the Digital Breast Tomosynthesis (DBT) systems, which are further in the
text jointly referred to as Planmed FFDM/DBT system, while the respective FFDM/DBT X-
ray units are referred to as the Planmed X-ray unit, or just X-ray unit. Any features
differentiating said systems or X-ray units from each other are specified further in the text.
NOTE
The stereobiopsy and tomosynthesis features are optional depending on the distribution
region, and may not be included in the Planmed Clarity mammography X-ray unit delivery.
1.1 Associated documentation

The following manuals are provided with the Planmed FFDM/DBT system:
• Planmed Clarity 2D/3D User’s Manual (20009437)
includes detailed descriptions of all the main parts of the X-ray unit and instructions
for taking images with the Planmed FFDM/DBT system. This manual is intended for
the technologists in their daily work.
• Planmed Clarity 2D/3D Installation Manual (20009439)
includes unpacking and installation instructions of the Planmed X-ray unit. This
manual is intended for the technical support personnel only.
• Planmed Clarity Spare Parts Manual
includes detailed descriptions and figures of all spare parts that are available for the
Planmed X-ray unit. This manual is intended for the technical support personnel only.

Chapter A: GENERAL & TECHNICAL DATA
1.2 How to find information in this manual

For operating instructions, please refer to the Planmed Clarity X-ray Unit User’s Manual.
Said manual contains also full explanations of all adjustments that the user can make from
the control panels.
For navigation, please refer to the table of contents in the beginning of this manual. A brief
description of the chapters in this manual is given below.
Chapter A: "GENERAL & TECHNICAL DATA" on page 7 (this

chapter)
This chapter contains general information, detailed technical specifications of the X-ray
unit and a list of abbreviations used in this manual. Here you can find answers to all
questions related to the technical specifications of the X-ray unit. This chapter also
includes a brief overview of the whole Planmed FFDM/DBT system.
Chapter B: "CONTROL PANEL DISPLAYS" on page 43

This chapter contains an overview of the user interface functions that are available for
service purposes. For explanation of normal user operations, refer to the Planmed Clarity
User’s Manual.
The detailed descriptions of all adjustments performed through the touch screen can be
found in Chapter D: "ADJUSTMENT & CALIBRATION" on page 81.
Chapter C: "PREVENTIVE MAINTENANCE" on page 67

This chapter describes the regular maintenance procedures of the operator. Complete
step-by-step instructions on how to check the performance of the X-ray unit are also
included. Some of these checks must be performed annually and before using the X-ray
unit.
Chapter D: "ADJUSTMENT & CALIBRATION" on page 81

This chapter contains instructions on how to perform adjustments and calibrations using
the keyboard, mechanical adjustments, as well as adjustments of sensors and switches.
Chapter E: "PARTS REPLACEMENT AND REPAIR" on page 129

This chapter contains instructions on how to replace both mechanical and electrical parts
of the X-ray unit. It also describes the possible calibrations and adjustments that must be
performed after replacing particular parts. Instructions on how to update the software
versions on the CPUs are also included in this chapter.
Chapter F: "PLANMED CLARITY MANAGER" on page 157

This chapter describes how to install and configure the Planmed Clarity Manager software.
Chapter G: "PLANMED CLARITYGUIDE" on page 197

This chapter describes the calibrating and testing procedures of the Planmed ClarityGuide
system.
Chapter H: "DIAGRAMS" on page 221

This chapter contains the electrical wiring diagrams and schematics of the X-ray unit.

Chapter A: GENERAL & TECHNICAL DATA 2 PLANMED CLARITY FFDM SYSTEM
2 PLANMED CLARITY FFDM SYSTEM
2.1 System setups

The following figures show the main parts of the Planmed Clarity FFDM/DBT system.
Figure 1: Planmed Clarity FFDM/DBT system, basic setup.
Planmed
DigiPad
Nuance_wiring_new2.eps

2 PLANMED CLARITY FFDM SYSTEM Chapter A: GENERAL & TECHNICAL DATA
Figure 2: Planmed Clarity FFDM/DBT system, an optional setup
1
10
Planmed
DigiPad
Clarity_AWS2_new.eps
e
c 2
3
c
a
d
The Planmed Clarity FFDM/DBT system includes the following main elements, see the
figure 1 and figure 2, and the table below.
Item Cables, length (part number)

1) Review Workstation (RWS, optional) a) Detector Ethernet cable, 2,7m (20008880)
2) Private network b) Control Ethernet cable, 2,7m (20008880)
3) Medical grade isolation c) Foot control cable, 1,8m (20000537)
4) Radiation shield d) Remote control cable, 3,5m (20008286)
5) Planmed Wave acquisition desk e) Mains cable EU, 4,5m (07827711)
(optional)
6) Acquisition Workstation (AWS)
7) Clarity Isolation Transformer (CIT)
8) Ethernet cable
9) Ethernet cable
10) Planmed Clarity mammography unit
NOTE
In order to avoid excess patient leakage currents the AWS must be isolated from the local
area network with a medical grade isolation device.

NOTE
Only Clarity Isolation Transformer (CIT) provided by Planmed is allowed to be used.
Planmed offers a choice of two different radiation shields, shown in the above figures:
• A separate screen (Planmed Radiation Shield, PRS)
• An integrated screen which is attached to the acquisition desk (Planmed Wave)
NOTE
PRS is an optional item. However, radiation protection must be provided by any radiation
shield that fulfils the following requirements:
- The minimum required protective shielding is 60 cm (24 in) wide, minimum 185 cm (73 in)
high, and less than 15 cm (6 in) above the floor
- The material used must have a minimum attenuation equivalent of 0.08 mm of lead (pb)
and it must provide visibility to the patient and equipment
NOTE
Local regulations must be obeyed in case they differ from the above.
The Planmed X-ray unit includes a digital Flat Panel Detector (FPD) that utilises
amorphous silicon to convert the incoming X-ray photons into an electrical signal.
Digital mammography images are acquired and optimised at the AWS consisting of a
computer, a display, and a keyboard. The AWS is connected the X-ray unit with an
Ethernet cable.
NOTE
Only workstation provided by Planmed is allowed to be used in the AWS.
The AWS can be located in the optional Planmed Wave acquisition desk which is
equipped with motorised height adjustment, and an isolation transformer.
The AWS contains Planmed Clarity Manager software application. It is used for acquiring
mammographic images with the Planmed FFDM/DBT system, and for calibrating the
digital detector, for quality assurance, and for monitoring and maintaining the performance
of the Planmed X-ray unit.
The optional RWS includes the Planmed Review application, which can be used to review
the mammographic images to make a diagnosis. The RWS is connected to the AWS
through a local area network (for example, a hospital network).

2.2 Mammography unit

The following figure shows a general side view of the Planmed Clarity mammography unit.
2
3
Clarity_left_BOM.eps
1. C-arm 2. Touch screen

3. Digital detector 4. Column
5. Base

2.3 Characteristics of use

For image acquisition the X-ray unit and the Acquisition workstation (AWS) work as a
unified whole. They both have clearly defined roles but are dependent of each other to
achieve imaging.
For non-imaging activities the X-ray unit and AWS can be viewed as independent entities
that can perform different tasks simultaneously.
1. The X-ray unit focuses on the next image to be acquired.
Imaging view and

values are selected
from the touch-
screen.
Imaging mode is
activated with
Clarity_CharOfUse_1
imaging equipment.
Breast positioning is
done with many
manual controls.
2. AWS focuses on patient information and the acquired images.
Workstation is used
to handle patient
data, set up study
and to verify image
quality.
Clarity_CharOfUse_2

3. Together the X-ray unit and AWS display a unified imaging status.
Exposure switch is
used to acquire an
image.
Clarity_CharOfUse_3

Chapter A: GENERAL & TECHNICAL DATA 3 WARNINGS AND PRECAUTIONS
3 WARNINGS AND PRECAUTIONS
WARNING
The following warnings, cautions and notes must always be considered while ser -
vicing in order to avoid either personal injury or damage to the X-ray unit.
CAUTION
RADIATION SAFETY RULES
Some procedures described in this manual produce X-ray radiation. Always follow
the rules for radiation safety.
Never touch or scratch the surface of the X-ray tube radiation window. The window
is made of beryllium, which can be harmful if inhaled or swallowed.
Never attempt to open the tubehead. It does not contain any serviceable parts.
Opening the tubehead makes it inoperable and voids the warranty.
Never make any exposures without an appropriate filter (Rh/Ag) in the radiation
beam, or without the beam-limiting device (collimator) in place. Otherwise the radi -
ation safety cannot be guaranteed.
CAUTION
ELECTRICAL SAFETY RULES
The X-ray unit contains hazardous voltages. While servicing internal parts, always
disconnect the X-ray unit from the mains (if possible) by removing the plug from the
wall outlet, and wait for 2 minutes before touching any electrical parts.
Always replace the fuses with ones of the same type and rating. Otherwise patient,
operator, and equipment safety cannot be guaranteed.
The circuit boards can be damaged due to static discharges and require careful
handling and storage.
CAUTION
GENERAL SAFETY RULES
The X-ray unit must be serviced only by qualified personnel that is trained by
Planmed. Repairs and parts replaced by unqualified personnel are not under war -
ranty.
Periodic maintenance as described in this manual must be performed on a regular

basis to ensure safety of the X-ray unit and image quality.
Some procedures described in the manual may jeopardize the function of the X-ray
unit, if not followed as stated.
CAUTION
The Planmed X-ray unit is not suitable for use in the presence of a flammable
anaesthetic mixture with air or with oxygen or nitrous oxide.
NOTE
There are parts where toxics, including lead (Pb), are used in this product. Therefore,
please execute proper processing of disposal in accordance with law, after consulting with
our distributor about the disposal.
NOTE
Portable and mobile RF communication equipment can affect the Planmed X-ray unit.

3 WARNINGS AND PRECAUTIONS Chapter A: GENERAL & TECHNICAL DATA
NOTE
Handle the Planmed X-ray unit according to the instructions given in this manual. Do not
handle the Full Field Digital detector with sharp objects and do not place or drop anything
on it. The Planmed limited warranty does not cover damage which is due to misuse,
neglect, or any cause other than ordinary application.
NOTE
Keep the room temperature between +10 °C and +33 °C (+50 °F and +91 °F) at all times.

Chapter A: GENERAL & TECHNICAL DATA 4 SYMBOLS AND PRODUCT LABELS
4 SYMBOLS AND PRODUCT LABELS
4.1 Symbols on product labels
Type B applied part (Standard IEC 60601-1).
Alternating current (Standard IEC 60601-1).
Attention, consult accompanying documents (Standard IEC 60601-1).
X-ray source assembly: emitting (Standard IEC 60417).
Separate collection for electrical and electronic equipment according to Directive 2002/96/
EC (WEEE).
Attention, consult accompanying documents (Standard ISO 7010-M002).
Notes, Cautions, and Warnings
NOTE
Note messages are used to indicate information which may be helpful or of special interest
to the reader.
CAUTION
Caution statements alert the user to the possibility of a problem with the unit asso-
ciated with its use or misuse. Such problems include unit malfunction, unit failure,
damage to the unit or damage to other property.
WARNING
Warning statements alert the user to the possibility of personal injury to the user or
the patient, or other serious damage associated with the use or misuse of the unit.

4 SYMBOLS AND PRODUCT LABELS Chapter A: GENERAL & TECHNICAL DATA
4.2 Product labels
Sign labels
Clarity_stickers.eps

Connections and fuse labels
Clarity_stickers2.eps
X-ray unit and tube head labels
MAMMOGRAPHY X-RAY UNIT

TYPE: PLANMED CLARITY
SN: X : XX/20XX
208 VAC 50/60 Hz-240 VAC 50 Hz, STANDBY 250 VA/4,5 kVA 5 s
MINIMUM OVERCURRENT RELEASE 16 AT (USA 15 AT)
MAXIMUM APPARENT RESISTANCE OF SUPPLY MAINS: 0,5 Ω
LIFT AND C-ARM ROTATION MOTORS’ OPERATION:
Intermittent operation, ED 8 %, 25 sec “ON”, 300 sec “OFF”
35 kV maximum TOTAL FILTRATION: 60 μm Rh, 75 μm Ag kV
LBL-7870503-B
MANUFACTURER: mA
PLANMED OY, SORVAAJANKATU 7,
00880 HELSINKI, FINLAND
Complies with DHHS radiation perfor-
mance standard 21 CFR subchapter J 0598 -C
Complies with IEC 60601-2-45:2011
(01) 0 0000000 00000 0

(11) 000000
(21) serialnumber
MAMMOGRAPHY X-RAY UNIT MEDICAL - APPLIED ELECTROMAGNETIC

RADIATION EQUIPMENT AS TO
TYPE: PLANMED CLARITY ELECTRICAL SHOCK, FIRE AND
SN: X : XX/20XX MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH
208 VAC 50/60 Hz-240 VAC 50 Hz, STANDBY 250 VA/4,5 kVA 5 s ANSI/AAMI ES60601-1 (2005)+AMD 1 (2012)
MINIMUM OVERCURRENT RELEASE 16 AT (USA 15 AT) CAN/CSA C22.2 No. 601601-1 (2014)
E481915
MAXIMUM APPARENT RESISTANCE OF SUPPLY MAINS: 0,5 Ω
30011292/A
CAUTION
LIFT AND C-ARM ROTATION MOTORS’ OPERATION: FEDERAL LAW RESTRICTS THIS
Intermittent operation, ED 8 %, 25 sec “ON”, 300 sec “OFF” DEVICE TO SALE BY OR ON THE
35 kV maximum TOTAL FILTRATION: 60 μm Rh, 75 μm Ag ORDER OF A PHYSICIAN
kV
LBL-7870503-B
MANUFACTURER:
mA
PLANMED OY, SORVAAJANKATU 7,
00880 HELSINKI, FINLAND
Complies with DHHS radiation perfor-
mance standard 21 CFR subchapter J
Complies with IEC 60601-2-45:2011 0598 -C
Clarity_stickers3_1.eps
MEDICAL - APPLIED ELECTROMAGNETIC

RADIATION EQUIPMENT AS TO
ELECTRICAL SHOCK, FIRE AND
MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH
ANSI/AAMI ES60601-1 (2005)+AMD 1 (2012)
CAN/CSA C22.2 No. 601601-1 (2014) (01) 0 0000000 00000 0
E481915 (11) 000000
30011292/A
CAUTION (21) serialnumber

FEDERAL LAW RESTRICTS THIS
DEVICE TO SALE BY OR ON THE
ORDER OF A PHYSICIAN

Detector label
Clarity_stickers_shelf.eps
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Det so m p th pla hing
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70
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L-
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WARNING! Do not lay anything on the top of the
detector if bucky is not in place.
Keep the surface clean, wipe with soft,
damp cloth. Use specified cleaning
LBL-7870550-A
solutions only, if needed. Do not use
excessive force when cleaning.
Varian Detector 3024M SN: XXXXXX
Face guard label

LBL-7870538-A
Face Guard Ocean

20009177 XX/20XX
MANUFACTURED BY: PLANMED OY, 00880 HELSINKI FINLAND
uard.eps
Clarity_stickers_face_g

Bucky/platform label
Clarity Bucky 24 x 30
20009103
SN: XXXXXX XX/20XX
MANUFACTURED BY: Complies with DHHS
LBL-7870522-A
radiation performance
PLANMED OY, standard 21 CFR
00880 HELSINKI FINLAND subchapter J
-A
52
04
7
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LB
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MANUFACTURED BY: PLANMED OY, 00880 HELSINKI FINLAND
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Tube head and beam limiting device labels
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Clarity_stickers_tube_head.eps
Generator label
Clarity_stickers_generator.eps

5 SOFTWARE VERSIONS & COMPATIBILITY Chapter A: GENERAL & TECHNICAL DATA
5 SOFTWARE VERSIONS & COMPATIBILITY

Basic provisions
Since the Planmed X-ray unit is fully microprocessor controlled, its operation is controlled
by the currently installed software. Planmed reserves the right to improve functionality or
to add new features to the product by modifying the software and/or hardware. Manuals
are updated accordingly and technical bulletins published in order to inform about changes
or additions.
To check the latest manual and software versions as well as their compatibility
information, visit the Planmed Dealer Support web pages at the address:
https://dealersupport.planmed.com
The technical bulletins can also be found there.
Software numbering & compatibility

The X-ray unit contains five microprocessors that must be able to communicate with each
other. Incompatible software versions should never be used together. In this case, the X-
ray unit may be totally non-functional, produce continuous error codes, or some important
features or functions may be missing. However, no damage or safety hazard will result if
two non-compatible software versions are accidentally used together.
Current software versions

This technical manual is valid for the following software version:
• Clarity Embedded SW 1.3.0
• Clarity Manager SW 1.3.0
If you find that your Planmed X-ray unit does not have some user interface functions, or its
user interface functions differ from those described in this manual, then either the software
must be replaced with at least the above mentioned version, or you have to refer to an
older version of this manual. The former procedure is recommended.
Hardware compatibility
As a general rule, new software releases are compatible with all existing hardware. New
software releases (or possible upgrading kits containing new software) are normally
directly compatible with existing hardware, but not necessarily without some re-calibration
procedures.

Chapter A: GENERAL & TECHNICAL DATA 6 TECHNICAL SPECIFICATIONS
6 TECHNICAL SPECIFICATIONS
ORIGINAL MANUFACTURER
Planmed Oy
Sorvaajankatu 7
00880 Helsinki
Finland
Tel.: +358-20-7795 300
Fax: +358-20-7795 664
MODEL AND APPROVALS

Model Planmed Clarity 2D / Planmed Clarity 3D
Approvals • IEC safety class: I
• IEC degree of protection: B
• IEC enclosure class: IP20
This mammographic X-ray equipment complies with following standards for Medical
electrical equipment:
IEC 60601-2-45:2015 Particular requirements for the basic safety and essential
performance of mammographic X-ray equipment and
mammographic stereotactic devices

6 TECHNICAL SPECIFICATIONS Chapter A: GENERAL & TECHNICAL DATA
6.1 X-ray tube assembly
X-RAY TUBE
X-ray tube type Varian M113T
Anode type Rotating anode (9700 rpm at 180 Hz)
Anode braking Automatic, electrical
Anode thermal capacity 300 000 HU
Anode target material Tungsten
Anode target angles • 16 degrees (large focus)
• 10 degrees (small focus)
Tube port material 0.63 mm Beryllium
Focus sizes 0.3 mm / 0.1 mm (IEC60336)
Filtration 75 µm Ag and 60 µm Rh
Weight 17.5 kg (39 lbs)
Nominal continuous anode input power 250 W (at maximum anode voltage under
any operating condition)
Maximum nominal input power 3200 W
X-RAY FIELD SIZE

X-ray field size for 24x30 cm image 235 x 300 mm ±5 mm
receptor
X-ray field size for spot imaging Square 80 x 140 mm ±5 mm
GENERATOR ASSEMBLY
Generator Constant potential, high frequency
Anode voltage range 23 - 35 kV ± 2 kV, virtually DC
Anode current range/0.3mm focus 91 - 120 mA ± 5 mA
Anode current range/0.1mm focus 31 - 42 mA ± 3 mA
mAs range/0.3mm focus 5 - 600 mAs
± 4 mAs or ±10% (whichever is larger)
mAs range/ 0.1mm focus 10 - 400 mAs
Exposure time /0.3mm focus 0.1 - 5 seconds ±5%
Exposure time / 0.1mm focus 0.1 - 9.9 seconds ±5%
Cooling Automatically controlled (internal fan)
Line voltage 208 VAC 50/60 Hz - 240 VAC
50 Hz, single phase
Line voltage compensation Automatic ±10%
Line voltage regulation ±10% (absolute minimum/maximum)
187 V~ / 265 V~)
Fuses 2 x 15 AT / 250 V

Total power consumption Max. 250 VA idle

4500 VA max. for 5 seconds
Power factor > 0.95
Mode of operation Intermittent, 5 sec. ON
Maximum mains resistance 0.5 Ω
Maximum continuous heat dissipation < 250 W, 850 BTU/h
Figure 3: X-ray tube assembly

196 500
68 (LF)
66 (SF)
30 (SF)
24 (LF)
196
SF = SMALL FOCAL SPOT CENTRAL BEAM AND

LF = LARGE FOCAL SPOT REFERENCE AXIS
8˚
PATIENT SUPPORT
90

6 TECHNICAL SPECIFICATIONS Chapter A: GENERAL & TECHNICAL DATA
6.2 Bucky grid

Grid movement Variable speed sweep
Grid ratio r5
Grid lines per cm N31
Focusing distance f065
Material of absorbing strips Pb

Contrast improvement ratio K1.44
Grid exposure factor K1.91
Max. deviation between the central line 2 mm
indication and the true central line
6.3 Automatic Exposure Control (AEC)

Sensors Full field detection
Function modes AEC utilizes Flex AEC technology
AEC kV range ±3 kV from initial kV
6.4 C-arm
Rotation Motorized, range -135° to +180°
Vertical movement Motorized, range 810 mm to 1380 mm
(31.9 in to 55.1 in)
Focal spot to Skin Distance (FSD) • 470 mm to 635 mm (18.5 to 25 in) in
contact mode
• 262 mm to 427 mm (10.3 to 16.8 in) in
magnification mode 1.6
• 262 mm to 382 mm (10.3 to 15 in) in
magnification mode 1.8
• 485 mm to 635 mm (19.1 to 25 in) in
tomosynthesis mode
SID 650 mm
Attenuation equivalent of patient support 0.12 mm Al (at 30kV)
Compression Motorized
Magnification 1.6 or 1.8
Max. patient load 4 kg
Lift and C-arm rotation motors’ operation Intermittent operation
Effective duty cycle is 8%, 25 sec “ON”, 300
sec “OFF”

6.5 Mechanical data

Dimensions (H x D x W) 1026 x 994 x 755 mm minimum
(40.4 x 39.1 x 29.7 in minimum)
Weight 185 kg (408 lbs), unpacked
Colour RAL 9016 (with 5 selectable accentuation
colours)
6.6 Temperatures and humidity

Operating temperature +10°C to +33°C (50°F to 91°F)
Operating humidity Up to 90% non-condensing
Storage temperature -20°C to +70°C (-4°F to +168°F)
Transportation temperature -20°C to +70°C (-4°F to +168°F)
6.7 Dimensions
69...84 cm 100 cm
27.1...33.1” 39.4”
15 59.8
2 ”
cm
0...16 cm
0...6.3”
157...217 cm
61,8...85.4”
°
180
. ..+
35
-1 31,9...54.3”
81...138 cm
78 cm 76 cm
30.7“ 29.9“

7 USER’S STATEMENT Chapter A: GENERAL & TECHNICAL DATA
7 USER’S STATEMENT
The maximum-rated peak tube potential is 35 kVp and the maximum rated continuous
tube current is 3.5 mA for the maximum-rated peak tube voltage.
Minimum filtration
The beam-limiting device contains two different filtrations: 75 µm silver and 60 µm
rhodium. The measured half value layers are for silver (Ag) 0.574 mmAl at 24 kVp and for
rhodium (Rh) 0.442 mmAl at 22 kVp.
Rated line voltage

208 - 240V~ ±10%. Line voltage regulation 10%
Maximum line current

Maximum 22 Amperes at absolute minimum stated mains voltage (187 V~)
Technique factors that constitute the maximum line current

condition
33 kV / 97mA
Generator rating and duty cycle

3.2 kW. The duty cycle and wait period can be calculated using the following formulas:
• Wait period = Tw = kV* mA* exp. Time / 500 W
• Duty Cycle = 1 / (1 + kV* mA / 500 W)
Maximum deviation of peak tube potential from indicated value

±2 kV
Maximum deviation of tube current from indicated value

±5 mA large focus, ±3 mA small focus
Maximum deviation of exposure time tube current product from

indicated value
±4 mAs or ±10%, whichever is larger
Maximum deviation of exposure time from indicated value

±5%
7.1 Definition of measurement criteria
Exposure time
The beginning and end points of the exposure time are defined at 70% of the peak
radiation waveform measured with a calibrated X-ray monitor.

Chapter A: GENERAL & TECHNICAL DATA 7 USER’S STATEMENT
Peak tube potential

Peak tube potential is defined as the measured high voltage mean value measured with a
calibrated non-invasive kVp meter.
Tube current
Tube current is defined using the resistance and voltage over the feedback resistor
measured with a calibrated multimeter. The mA value is then the voltage divided by the
resistance.
mAs product
mAs product is defined as the integral of tube current measurements over the exposure
time.
Nominal X-ray voltage together with the highest X-ray tube current
obtainable from the high-voltage generator when operated at its
nominal X-ray tube voltage
Varian M113T: 35 kV 91 mA - large focus, 35 kV 31 mA - small focus
Highest X-ray tube current together with the highest X-ray tube
voltage obtainable from the high-voltage generator when operated
at its highest X-ray tube current
Varian M113T: 120 mA 26 kV - large focus, 42 mA 26 kV - small focus
X-ray tube voltage and X-ray tube current which result in the
highest electric output power
Varian M113T: 33 kV 97 mA - large focus, 29 kV 38 mA - small focus
Nominal electric power for a load time of 0.1 s and at the nominal
X-ray tube voltage
Varian M113T: 33 kV 97 mA - 3201 W large focus, 29 kV 38 mA - 1102 W small focus
Nominal electric power at 30 kV, for loading time of 1 s, a cycle

time of 1 minute
Varian M113T: 30kV 106 mA -3,18 kW large focus, 30 kV 36 mA -1,08 kW small focus
Reference current time product

large focus: for all kV values 40 mA / 0.1s / 4 mAs
small focus: for all kV values 10 mA / 0.1s / 1 mAs
Lowest current time product within the specified range of

compliance
For manual exposures: 10.0 mAs
For AEC exposures:
large focus: 5 mAs
small focus: 5 mAs

7 USER’S STATEMENT Chapter A: GENERAL & TECHNICAL DATA
Nominal shortest irradiation time in the AEC mode

270 ms (lowered current)
X-ray tube reference axis

Centered laterally, one end directly above the chest wall edge at 630 mm distance from
the patient support surface, and the other end at the patient support surface 163 mm in
from the chest wall edge.
For stereotactic operation the end of the reference axis that is not at the patient support
surface is tilted 15 degrees clockwise and counter clockwise in the stereotactic
projections.
Focal spot location

Varian M113T: Both laterally centred with ±1.5 mm tolerance.
Large focus: 5.35 ±1.5 mm from the reference axis upper end towards the anode and 5.6
±1.5 mm below the reference axis upper end.
Small focus: 3.57 ±1.0 mm from the reference axis upper end towards the anode and 3.8
±1.5 mm over the reference axis upper end.
Radiation measurement
The radiation measurement value shown on the angle display of the mammography X-ray
unit is the radiation output measured at the height of 45 mm above the Bucky surface
without compression paddle.
7.2 X-ray tube ratings
Manual exposures
With manual exposures the tube kV and mAs can be selected by the user. In order to keep
the exposure times at minimum the required mAs is always achieved at the highest
possible tube current for the kV selected. The parameters are listed in the following table.
The possible mAs values are: 10, 11, 12.5, 14, 16, 18, 20, 22, 25, 28, 32, 36, 40, 45, 50,
56, 63, 71, 80, 90, 100, 110, 125, 140, 160, 180, 200, 225, 250, 280, 320, 360, 400, 450,
500, 560.
Automatic exposures
Automatic exposures are terminated when the radiation detector indicates that the
required dose has been reached. In this mode the kV is selected automatically and mA is
chosen to be the maximum allowed mA for the selected kV.
Thermal ratings
Two separate methods are used to protect the tube from overload. One is measuring the
tube head enclosure temperature and if it exceeds 60°C no further exposures are allowed
until it falls below 60°C.
The other method keeps the average input power into the tube below or equal to 500 W.
The exposure parameters are limited as indicated by the following table, but this feature
forces a waiting time between the exposures to ensure that the average power into the
tube never can exceed this limit. If an exposure of 24 kV, 100 mAs is performed, for
example, a wait period of 5 seconds is calculated and no further exposures are allowed
until this time has elapsed.

Chapter A: GENERAL & TECHNICAL DATA 7 USER’S STATEMENT
There is no way to bypass these safety features under any circumstances, and it is thus
virtually impossible to overload the X-ray tube.
Heat dissipation in normal use is 250 W (850 BTU/h.) that does not require any external
cooling preservations to be made for room operated in.
Maximum mA for tube M113T vs. different modes
MANUAL AND AUTOMATIC (AEC) EXPOSURE MODE MODE
Large focus Small focus

(0.3 mm) (0.1 mm)
M - Manual
0.1 - 0.6 0-6 0 - 10 A - AEC
kV sec. with grid sec. sec.
23 108 38 M
24 112 39 M
25 116 41 M
26 120 42 M
mA = mAs / 0.6 sec.
27 118 40 M
28 114 39 M/A
29 110 38 M/A
30 106 36 M/A
31 103 35 M/A
32 100 34 M/A
33 97 33 M/A
34 94 32 M/A
35 91 31 M/A
7.3 Cooling curves for the X-ray tubes

Figure 4: Cooling curves for Varian M113T
700
TUBE HOUSING
HEAT DISSIPATION CAPACITY
600
500
HEAT STORAGE (kHU)
400
300
200
100
0
0 50 100 150 200 250
TIME (min)

8 AMORPHOUS SILICON (-Si) FLAT PANEL DETECTOR Chapter A: GENERAL & TECHNICAL DATA
8 AMORPHOUS SILICON (-Si) FLAT PANEL

DETECTOR
ORIGINAL MANUFACTURER
VARIAN Medical Systems / Varex Imaging
1678 South Pioneer Road
Salt Lake City
UT 84104-4298
USA
MODEL AND MECHANICAL DATA

Model Pax Scan 3024M
Detector technology TFT/PIN Photodiode amorphous silicon
FPD
Overall dimensions (L x W x H) 330 x 261 x 49 mm
Power consumption 30 W
Weight 3.0 kg
ENVIRONMENTAL REQUIREMENTS
Operating temperature +10 °C to +35 °C (50 °F to 95 °F)
Operating humidity Up to 90% non-condensing
Storage temperature -20 °C to +70 °C (-4 °F to +158 °F)
Transportation temperature -20 °C to +70 °C (-4 °F to +158 °F)
GENERAL CHARACTERISTICS
Pixel pitch 83 x 83 µm
Resolution 2816 x 3584 pixels
Active area 234 x 297 mm
CsI scintillator thickness 250 µm
Read time 0.7 s
Time between X-ray images Approx. 20 s

Chapter A: GENERAL & TECHNICAL DATA 9 RADIATION SHIELD
9 RADIATION SHIELD
GENERAL REQUIREMENTS
Minimum height 1850 mm (72.8 in.)
Minimum width 600 mm (23.6 in.)
Minimum lead equivalency 0.083 mmPb
Material used Must provide visibility to the patient and to
the equipment
Distance from the floor Less than 150 mm (5.9 in.)
NOTE
Follow local regulations if they differ from the above.
PLANMED RADIATION SHIELD

Height 1880 mm (74 in.)
Width 775 mm (30.5 in.)
Lead equivalency 0.3 mmPb
0.5 mmPb
Weight 0.3 mmPb 56 kg (123 lbs)
0.5 mmPb 60 kg (132 lbs)
Protective leaded acrylic plate 0.3 mmPb at tube voltage 50 kV

10 EMC INFORMATION Chapter A: GENERAL & TECHNICAL DATA
10 EMC INFORMATION
WARNING
Use of any accessories and cables other than those specified in Planmed X-ray
unit’s documentation, with the exception of cables sold by Planmed as replacement
parts for internal components, may result in increased emission or decreased
immunity of the Planmed X-ray unit.
WARNING
The Planmed X-ray unit should not be used adjacent to or stacked with other equip -
ment. If adjacent or stacked use is necessary, the Planmed X-ray unit should be
observed to verify the normal operation in the configuration in which it will be used.
Guidance and manufacturer’s declaration - electromagnetic emissions

The Planmed X-ray unit is intended for use in the electromagnetic environment specified below.
The customer or the user of the Planmed X-ray unit should assure that it is used in such an
environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions The Planmed X-ray unit uses RF energy only for
Group 1 its internal function. Therefore, its RF emissions
are very low and are not likely to cause any
CISPR 11
interference in nearby electronic equipment.
RF emissions The Planmed X-ray unit is suitable for use in all
Class B establishments, including domestic
establishments and those directly connected to
CISPR 11
the public low-voltage power supply network that
Harmonic emissions supplies buildings used for domestic purposes.
Class A
IEC 61000-3-2
Voltage fluctuations/
flicker emissions Complies
IEC 61000-3-3

Chapter A: GENERAL & TECHNICAL DATA 10 EMC INFORMATION
Guidance and manufacturer’s declaration - electromagnetic immunity

The Planmed X-ray unit is intended for use in the electromagnetic environment specified below. The
customer or the user of the Planmed X-ray unit should assure that it is used in such an environment.
Immunity test IEC 60601 Compliance level Electromagnetic environment
test level guidance
Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete
discharge (ESD) ±8 kV air ±8 kV air or ceramic tile. If floors are
IEC 61000-4-2 covered with synthetic material,
the relative humidity should be at
least 30%.
Electrical fast ±2 kV for power ±2 kV for power Mains power quality should be
transient/burst supply lines supply lines that of a typical commercial or
IEC 61000-4-4 ±1 kV for input/output ±1 kV for input/output hospital environment
lines lines
Surge ±1 kV line to line ±1 kV line to line Mains power quality should be
IEC 61000-4-5 ±2 kV line to earth ±2 kV line to earth that of a typical commercial or
hospital environment.
Voltage dips, short <5% UT <5% UT Mains power quality should be

interruptions and (>95% dip in UT) (>95% dip in UT) that of a typical commercial or
voltage variations for 0.5 cycle for 0.5 cycle hospital environment.
on power supply
input lines 40% UT 40% UT
(60% dip in UT) (60% dip in UT)
IEC 61000-4-11
for 5 cycles for 5 cycles
70% UT 70% UT
(30% dip in UT) (30% dip in UT)
for 25 cycles for 25 cycles
<5% UT <5% UT
(>95% dip in UT) (>95% dip in UT)
for 5 s for 5 s
Power frequency 30 A/m 30 A/m Power frequency magnetic fields
(50/60 Hz) should be at levels characteristic
magnetic field of a typical location in a typical
IEC 61000-4-8 commercial or hospital
environment. The power
frequency magnetic field should
be measured in the intended
installation location to assure that
it is sufficiently low.
Note: UT is the a.c. mains voltage prior to the application of the test level.

10 EMC INFORMATION Chapter A: GENERAL & TECHNICAL DATA
Guidance and manufacturer’s declaration - electromagnetic immunity

The Planmed X-ray unit is intended for use in the electromagnetic environment specified below. The
customer or the user of the Planmed X-ray unit should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance Electromagnetic environment guidance
level
Portable and mobile RF communications
equipment should be used no closer to any
part of the Planmed X-ray unit, including
cables, than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance
Conducted RF 3 Vrms 3 Vrms d = 1,2 P
IEC 61000-4-6 150 kHz to 80 MHz
d = 1,2 P 80 MHz to 800 MHz
Radiated RF 3 V/m 3 V/m d = 2,3 P 800 MHz to 2.5 GHz

IEC 61000-4-3 80 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey,a should be less than the compliance
level in each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the Planmed X-ray unit is used exceeds the applicable RF compliance level above, the
Planmed X-ray unit should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the Planmed X-ray unit.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Chapter A: GENERAL & TECHNICAL DATA 10 EMC INFORMATION
Recommended separation distances between portable and mobile RF communications equipment and the
Planmed X-ray unit
The Planmed X-ray unit is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of Planmed X-ray unit can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Planmed X-ray unit as recommended below, according to
the maximum output power of the communications equipment.
Rated maximum output power Separation distance according to frequency of transmitter
of transmitter m
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
W
d = 1,2 P d = 1,2 P d = 2,3 P
0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12.0 12.0 23.0
For transmitters rated at a maximum output power not listed above, the recommended separation distance d
in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 Mhz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

11 LIST OF ABBREVIATIONS Chapter A: GENERAL & TECHNICAL DATA
11 LIST OF ABBREVIATIONS
Table 1: Abbreviations
Abbreviation Definition
ACR American College of Radiology
AEC Automatic Exposure Control
Ag Silver
AGD Average Glandular Dose
Al Aluminum
AWS Acquisition Workstation
C/D Contrast/Dose
CC Cranio-Caudal
CPU Central Processing Unit
CR Computed Radiography
DICOM Digital Imaging and Communications in Medicine
DBT Digital Breast Tomosynthesis
DQE Detective Quantum Efficiency
EC European Community
EEC European Economic Community
EMC Electromagnetic Compatibility
Er Error
EXP Exposure
FB From Below
FDA Food and Drug Administration
FFDM Full Field Digital Mammography
FPD Flat Panel Detector
HE Help
HVL Half Value Layer
IEC International Electrotechnical Commission
LAT Lateral
LCC Left Cranio-Caudal
LLM Left Latero-Medial
LLMO Left Latero-Medial Oblique
LM Latero-Medial
LMLO Left Medio-Lateral Oblique
MAG Magnification
MAN Manual
ML Medio-Lateral
MTF Modulation Transfer Function
MV MaxView

Chapter A: GENERAL & TECHNICAL DATA 11 LIST OF ABBREVIATIONS
Table 1: Abbreviations
OBL Oblique
PA Posterior-Anterior
PACS Picture Archiving and Communication System
PC Personal Computer
PCB Printed Circuit Board
PIM Panel Interface Module
PMMA Polymethylmetacrylate
PRS Planmed Radiation Shield
RCC Right Cranio-Caudal
RF Radio Frequency
Rh Rhodium
RLM Right Latero-Medial
RLMO Right Latero-Medial Oblique
RMLO Right Medio-Lateral Oblique
RWS Review Workstation
SID Source to Image Distance
SSP Special System Parameter
ST Stereotactic
WEEE Waste Electrical and Electronic Equipment

11 LIST OF ABBREVIATIONS Chapter A: GENERAL & TECHNICAL DATA

Chapter B: CONTROL PANEL
DISPLAYS
It is important to configure the Planmed Clarity mammography X-ray unit user interface to
meet user's preferences and needs. The user interface can be easily optimised for
different purposes, e.g. for screening mammography or for diagnostics mammography.
NOTE
By optimising the user interface to be as simple as possible, the better user experience it
is for both, the patient and the user. As well as the time used per patient gets shorter.

1 TOUCH SCREEN OVERVIEW

The touch screen control panel is used to control all operations of the Planmed Clarity
mammography unit. There’s a touch screen on both sides of the device. They are identical
and either, or both of them, can be used to operate the device.
This manual, focuses on the SERVICE & CONFIGURATION menu functions, intended
only for trained technicians. In addition, few maintenance and information related menus
are introduced in this manual. Other menu functions are described and instructed in the
Clarity User’s manual.
NOTE
The views and values shown in this manual are only examples.
CAUTION
Do not use sharp objects to operate the touch screen.
1.1 Common icons and buttons

In the following, few graphical elements, common for all service & configuration menu
screens are explained.
Top menu button

To open the top menu, touch the Top menu button.
Save button
To save and activate changes in the current view, touch the Save
button.
Restore button
To restore the default values to the current view, touch the Restore
button.

1.2 Information and About sheets
1.2.1 Information button

At the top of all touch screen menus there is an Information button, see figure below.
By touching the Information button, the Information sheet appears, see next section.
1.2.2 Information sheet

In the Information sheet (the figure below), there are few buttons and information
available, see descriptions under the figure.
• Device status box

• In the Compression release item, there is a pair of buttons to enable or disable
compression auto release.
• The 2nd item in the box displays the current focus mode.
• The 3rd item displays the currently activated filter.
• By touching the About button a separate About sheet appears, see the next
section.
• Touch screen cleaning box
By touching the Disable for 15 s. button, the touch screen goes inactive, enabling
easy cleaning of the display.
• Last notifications box
The latest error and notice messages are displayed.

1.2.3 About sheet

The About sheet contains several information fields.
• Software versions box

The Clarity software version(s) currently active is displayed.
• Last preventive maintenance box
Displays the date of the last preventive maintenance and displays the days left for the
next recommended maintenance.
• Exposure counter box
Displays the count of taken exposures for both 2D and tomosynthesis.
• Serial numbers box
Displays the serial numbers of different parts of the X-ray unit.

Chapter B: CONTROL PANEL DISPLAYS 2 SERVICE & CONFIGURATION MENU
2 SERVICE & CONFIGURATION MENU

The SERVICE & CONFIGURATION menu provides easy diagnostics and special set-up
and calibration functions. In addition, there are some special control and display modes
that are not normally available.
CAUTION
Some of the functions in the service & configuration menu may jeopardize the
proper operation of the X-ray unit. Never use the service & configuration menu
functions if you are not familiar with the operation.
WARNING
Never allow patients to touch the screen when they are positioned in the X-ray unit.

2 SERVICE & CONFIGURATION MENU Chapter B: CONTROL PANEL DISPLAYS
2.1 Entering and exiting SERVICE & CONFIGURATION menu
2.1.1 To enter SERVICE & CONFIGURATION menu

1. In the main view of the control panel, touch the top menu button in the top right corner
of the screen.
2. Touch the SERVICE & CONFIGURATION field in the top menu.
2.1.2 To enter SERVICE & CONFIGURATION menu password protected views

Most of the functions in the SERVICE & CONFIGURATION menu are meant for service
personnel only and are protected with a password.
The password protected views under the SERVICE & CONFIGURATION menu are:
• Maintenance
For more information on the Maintenance view, see section 2.8 "Updating
maintenance information" on page 98.
• Configuration: Drives and Exposure tabs
For more information on the Configuration view, see section 2.6 "Adjusting movement
settings" on page 96.
• Calibration: all tabs
For more information on the Calibration view, see section 2.1 "Calibrating
compression force" on page 82.
• Diagnostics: all tabs
For more information on the Diagnostics view, see section 2.10 "Adjusting diagnostic
• Transportation
For more information on the Transportation view, see section 2.5 "Changing unit to
and from transportation mode" on page 94.
• Acquisition: all tabs
For more information on the Acquisition view, see section 2.11 "Adjusting acquisition
There are two ways of using the functions in the password protected menus:
• Commonly, the service personnel logs in to the Clarity Manager using an
administrator account with full SERVICE & CONFIGURATION menu access. In this
case the Clarity X-ray unit allows the administrator personnel to open all password
protected menus.

Chapter B: CONTROL PANEL DISPLAYS 2 SERVICE & CONFIGURATION MENU
• Other way is to enter the password when accessing the password protected views,
see instructions below.
• Enter the PIN code in the appearing numeric keypad. The PIN code is 1643.
- left arrow (<--) button clears last entered number
- 4th entered number acknowledges the PIN code
- Cancel button exits the PIN Code popup.
If the PIN code is correct, the selected screen appears.
2.1.3 To exit SERVICE & CONFIGURATION menu

Before exiting SERVICE & CONFIGURATION menu, remember to save the changes you
made to store them permanently.
1. Touch the top menu button in the top right corner of the screen.
2. Select and touch the desired mode.

3 NOTIFICATION AND ERROR MESSAGES Chapter B: CONTROL PANEL DISPLAYS
3 NOTIFICATION AND ERROR MESSAGES

If the device malfunctions or you make a mistake when using the equipment, an error
message appears on the display. Before corrective actions can be taken, clear the error
message from the display.
The following sections list the error messages and corrective actions.

Chapter B: CONTROL PANEL DISPLAYS 3 NOTIFICATION AND ERROR MESSAGES
3.1 Mammography unit errors
CODE MESSAGE CAUSES AND CORRECTIVE ACTIONS

100 The exposure switch is Cause: Exposure switch pressed for more than 8 seconds
activated. after exposure has ended.
Corrective action: Release exposure switch when
exposure has ended (beep has ended).
Check exposure switch.
101 Emergency stop button has Cause: STOP button has been activated.
been pressed. Corrective action: Release STOP button to restart the unit.
Cause: Open circuit in STOP line / CPUs are not able to
control or read the internal emergency STOP signal.
Corrective action: Check that the STOP signal wiring is OK
(this signal can be found on almost all boards). If the error
still occurs, replace the REAR CPU.
102 Emergency stop button Cause: STOP line active during startup.
failure or active during self Corrective action: Remove the obstruction.
test.
Release STOP button to restart the unit.
Cause: Open circuit in STOP line / CPUs are not able to
control or read the internal emergency STOP signal.
Corrective action: Check that the STOP signal wiring is OK
(this signal can be found on almost all boards). If the error
still occurs, replace the REAR CPU.
104 Exposure switch failure Cause: Exposure switch active during startup.
(short circuit) or pressed Corrective action: Remove the obstruction. Clear the error
during self test. code and the X-ray unit can be used.
Cause: Failure in the exposure switch.
Corrective action: Check the external exposure switch and
the cables for damage or short circuit. Disconnect the
remote control cable from the X-ray unit. If the error still
occurs, the problem is internal. Check the wiring from the
remote connector in the base to the Base Interface PCB,
and the wires from here to the Rear Interface PCB.
If you cannot find the fault, replace the PIM CPU. You can
view the switch signal using the diagnostic display.
105 Foot control switch failure Cause: One of the foot control switches was being held
(short circuit) or pressed down as the X-ray unit was carrying out its self-test during
during self test. start up, or there is a failure (short circuit) in the foot control
switch.
Corrective action: Remove the obstruction. Close the error
message to continue using the unit.
Check for mechanical damage on the switches. Disconnect
the foot controls from the X-ray unit. If the error still occurs,
the problem is internal. You can view the switch signal
using the diagnostic display of internal signals.

106 C-arm switch failure (short Cause: C-arm controls active during startup. This error can
circuit) or pressed during self occur only during the self-test when the X-ray unit checks
test. that all keys are open (the normal state if the key is not
pressed).
Corrective action: Remove the obstruction. Close the error
message to continue using the unit.
Cause: Key in short-circuit.
Corrective action: Replace defective Side Button PCB.
107 MaxView switch failure Cause: MaxView switches active during startup.
(short circuit) or pressed Corrective action: Remove the obstruction. Close the error
during self test. message to continue using the unit.
Cause: Key in short-circuit.
Corrective action: Replace defective MaxView module
control panel or C-arm control panel.
112 Exposure function disabled. Cause: Unit is in demo mode.
Configure to normal mode and restart.
113 STOP line integrity failure. Cause: STOP line test procedure failed during startup -
STOP line state not same on all CPUs.
Corrective action: Trace the STOP-named line from the
REAR CPU to the TUBE CPU and to the Shelf CPU.
Check the wiring between the processors. If everything
seems to be OK (check also for possible short circuits),
replace the TUBE CPU, the REAR CPU and the Shelf CPU
(replace the parts in this order).
Cause: STOP line test procedure failed during startup -
motor rotates when STOP is active.
Corrective action: Trace the STOP-named line from the
REAR CPU to the Rotation Drive PCB and Base Power
PCB. Check the wiring between the boards. If everything
replace the Rotation Drive PCB, the Base Power PCB
(replace the parts in this order).
Cause: Wrong connections on PIM PCB. PIM to Rear
Interface CAN cable disconnected or Clarity Guide
Handbox to PIM connector and PIM to Rear Interface CAN
cable cross-connected.
Corrective action: Check connections on PIM PCB.

114 Exposure line integrity Cause: Exposure line state is not same on all CPUs.
failure. Corrective action: Trace the EXP named line from the
REAR CPU to the PIM CPU and to the TUBE CPU. Check
the wiring between the two processors. If everything
replace the TUBE CPU and/or the REAR CPU and/or PIM
CPU PCB (replace the parts in this order).
Cause: EXP line should be active or inactive
simultaneously on Tube CPU, REAR CPU and PIM CPU.
You can view all the three switch signals using the
diagnostic display.
Corrective action: Trace the EXP named line from the
REAR CPU to the PIM CPU and to the TUBE CPU. Check
the wiring between the three processors. If everything
replace the TUBE CPU and/or the REAR CPU and/or PIM
CPU PCB (replace the parts in this order).
117 Tilt limit sensor failure. Cause: SLIM1 and SLIM2 limit sensors simultaneously
active.
Corrective action: Check the sensors and the wiring. You
can also view the sensor signals using the diagnostic
display.
Check C-arm Slot Sensor PCB, Stereo PCB, Shelf
Collector PCB and Tubehead Interface PCB and their
connections.
118 Compression limit sensor Cause: Upper and lower compression limit sensor
failure. simultaneously active.
can also view the sensor signals using the diagnostic
display.
Check Compression Connector PCB, Shelf CPU Interface
PCB and Rear Interface PCB, and their connections.
119 Rotation limit sensor failure. Cause: More than one of the rotation limit signals (upper,
lower or reference) active simultaneously.
can view the sensor signals using the diagnostic display.
Cause: The Rotation reference PCB in the rear of the
moving column is not functional or there is a problem in the
wiring.
Corrective action: Check the cable from the Rear interface
PCB to the Rotation reference PCB. This PCB has two
LED indicators: one for the power, the other for the signal.
120 Lift limit sensor failure. Cause: More than one of the lift limit signals (upper, lower
or reference) active simultaneously, when not in low limit.
Note that in low limit position both reference and low limit
signals are simultaneously active.
can view the sensor signals using the diagnostic display.
Check Rear Interface PCB.

121 Restoring configuration Cause: Reading of EEPROM configuration data block

failed. failed.
Corrective action: Check the cable from PIM PCB to RTC
PCB.
Cause: Faulty RTC PCB or PIM CPU PCB.
Corrective action: Replace RTC PCB or PIM CPU PCB.
122 Restoring configuration Cause: CRC of EEPROM configuration data block failed.
(CRC) failed. Corrective action: Check the cable from PIM PCB to RTC
PCB.
123 Saving configuration failed. Cause: Writing of EEPROM configuration data block failed.
PCB.
124 Exposure switch released Cause: Exposure switch released before exposure
during exposure. sequence has ended
Corrective action: Clear the error message. Take another
exposure. Remember to hold the exposure button down for
the whole duration of the exposure.
If the switch really was pressed firmly during the whole
exposure, the most probable cause for this error is a faulty
exposure switch or cable.
You can view the signal from the exposure switch using the
diagnostic display. The signal goes from the exposure
switch to Base Interface PCB, Rear Interface PCB, Tube
Interface PCB and to PIM CPU.
125 Exposure prepare phase Cause: Tube CPU has not acknowledged end of exposure
timeout. prepare phase in time.
Corrective action: If this error occurs constantly, replace
the TUBE CPU PCB.
126 Panel configuration timeout. Cause: Panel configuration ready acknowledgement not
received from AWS in time.
Corrective action: Restart unit. Check connection between
workstation and Flat Panel Detector.
127 Panel window timeout. Cause: Exposure window signal not received from detector
in time.
Corrective action: Check Varian Panel Control cable
between PIM CPU PCB and flat panel detector.
128 AEC parameter timeout. Cause: AEC main pulse parameters not received in time
from AWS.
Corrective action: Check connection between workstation
and unit.
129 X-ray tube cathode filament Cause: Filament calibration data is not present or is not
preheating voltages are not valid data.
calibrated. Corrective action: Perform the filament pre-heating
calibration.
130 Hardware configuration not Cause: Communication to one or more of the CPUs (Tube,
complete. Rear, Beam, Shelf) is down.
Corrective action: Check CAN bus wiring to all CPUs.

131 Software configuration Cause: Software version in one or more of the CPUs
incomplete (Tube, Rear, Beam, Shelf) is not according to currently
installed Embedded Software package.
Corrective action: Perform Embedded Software Update
procedure.
132 Tilt movement calibration Cause: Tilt movement calibration data in not present or is
information incomplete. not valid.
Corrective action: Perform tilt movement calibration.
Cause: Faulty RTC PCB.
Corrective action: Replace RTC PCB.
133 Up/down movement Cause: Lift movement calibration data in not present or is
calibration information not valid.
incomplete. Corrective action: Perform lift movement calibration.
134 Rotation movement Cause: Rotation movement calibration data in not present
calibration information or is not valid.
incomplete. Corrective action: Perform rotation movement calibration.
135 Force offset calibration Cause: Compression sensor offset control failed.
information incomplete. Corrective action: Perform compression force calibration.
Cause: Failure in wirings or in connections.
Corrective action: Check Compression Connector PCB,
Shelf CPU Interface PCB and Rear Interface PCB, and
their connections.
Cause: Faulty force sensor.
Corrective action: Replace Compression Arm.
136 Exposure pulse timeout. Cause: Tube CPU has not acknowledged end of exposure
pulse in time.
Corrective action: If this error occurs constantly, replace
the TUBE CPU.
137 RTC board initialization Cause: Initial communication with the Real Time Clock on
failed. RTC PCB has failed.
PCB.
Cause: Empty RTC PCB battery.
Corrective action: Replace RTC PCB battery.

138 Compression calibration Cause: Compression movement calibration - upper

information incomplete. (extension code 1) or lower (extension code 3) limit not
found.
Corrective action: Perform compression movement
calibration. Check Compression Connector PCB, Shelf
CPU Interface PCB and Rear Interface PCB, and their
connections. Replace compression columns.
Force calibration - upper limit not found (extension code
101), offset adjustment failed (extension code 103), force
input out of range (extension code 104).
Perform compression force calibration. Check
Compression Connector PCB, Shelf CPU Interface PCB
and Rear Interface PCB, and their connections. Replace
Compression Arm.
Cause: Paddle offset calibration - upper limit not found
(extension code 111), offset adjustment failed (extension
code 113), force rises too early (extension code 114), force
sensor open circuit (extension code 115), force not rising -
position (extension code 116), force decreasing (extension
code 117), force not rising - rate (extension code 118),
calibration data not valid (extension code 119), max force
not reached (extension code 120).
Corrective action: Perform paddle offset calibration. Check
paddle. Check corrective actions 1 and 2.
139 Compression motor timeout. Cause: Compression mechanism not moving even when
commanded - motor not rotating or position measurement
signal not changing. You can view the potentiometer signal
using the diagnostic display.
Corrective action: Check compression position sensor
cable from compression column to PIM CPU PCB.
Cause: Faulty position sensor.
Corrective action: Replace compression column.
Check function of PIM CPU PCB.
140 Exposure sequence failure. Cause: PEN signal not active at Tube CPU (extension
code 1), Exposure enabling failed (extension code 2). You
can view the signals using the diagnostic display.
Corrective action: Check PEN signal wiring (tubehead
interface cable). Check Rear CPU PCB and Tube CPU
PCB.
141 Guide unit was not removed Cause: Clarity guide was removed before executing the
safely. 'Remove guide unit' procedure.
Corrective action: Always execute the 'Remove guide unit'
procedure before removing guide unit.
Cause: Guide unit recognition failure or connection failure.
Corrective action: Check guide unit attachment,
connections and stereo interconnection cable, and stereo
cable.

142 Platform was removed Cause: Stereo biopsy platform removed before executing
during Stereo Procedure. 'End Procedure’.
Corrective action: Always execute 'End Procedure' before
removing stereo biopsy platform.
If the error appears during stereo procedure, problem
could be platform recognition failure or connection failure.
Check stereo biopsy platform attachment. Check platform
recognition and that the magnets on the platform are
correctly installed. Check Bucky sensor PCB.
143 Guide unit was removed Cause: Clarity Guide was removed before executing 'End
during Stereo procedure Procedure' procedure.
unsafely. Corrective action: Always execute 'Remove guide unit'
procedure before removing guide unit.
Cause: Guide unit recognition failure or connection failure.
Corrective action: Check guide unit attachment,
connections and stereo interconnection cable, as well as
stereo cable.
144 Do not remove Cause: Tomo platform removed before paddle (platform
Tomosynthesis Platform. hits paddle).
Corrective action: Always remove paddle before removing
tomosynthesis platform.
Cause: Platform recognition failure or connection failure.
Corrective action: Check tomosynthesis platform
attachment. Check platform recognition and that the
magnets on the platform are correctly installed. Check
Bucky sensor PCB.
145 Paddle offset calibration Cause: Paddle offset calibration data is not present for
information incomplete. currently connected paddle.
Corrective action: Perform paddle offset calibration.
Cause: Paddle recognition not working correctly -
connected paddle incorrectly detected. You can view if and
which paddle is detected using the diagnostic display.
Check paddle recognition and magnets on the paddle lock.
146 UI software configuration Cause: Clarity Flow touch panel software version is not
incomplete according to currently installed Embedded Software
package.
Corrective action: Update Clarity Embedded software.
147 Calibration of the unit Cause: Some of the calibrations are not completed.
incomplete Corrective action: Check calibrations in service mode and
complete calibrations.
148 Paddle detection dailure Cause: Paddle recognition not working correctly -
connected paddle incorrectly detected. You can view if and
which paddle is detected using the diagnostic display.
Corrective action: Check paddle recognition and magnets
on the paddle lock.
If the problem occurs and no paddle is attached, check the
connection between compression sensor PCB and PIM
CPU PCB.

201 Filament calibration invalid. Cause: The RTC CPU includes a non-volatile memory that
contains the preheating voltages for the X-ray tube
filaments and these parameters must be re-calibrated
whenever the Tubehead is replaced.
Corrective action: Perform the filament pre-heating
calibration.
202 Bucky motor drive failure. Cause: The Bucky grid mechanism not in reference
position. This error appears only during self test when
Bucky is attached or after exposure.
Corrective action: Make sure that the Bucky is locked
properly in place. You can view the sensor signal using the
diagnostic display.
Check bucky motor and connections. Check Shelf CPU
Interface PCB and Tubehead Interface PCB.
203 Tilt motor drive failure. Cause: The Stereo PCB cannot read the stereo motor
signals, or a faulty stereo motor. This may be caused by a
scratched pulse plate, by a faulty Stereo PCB, or by a
communication error between the Stereo PCB, the Clarity
Shelf CPU Interface PCB, and the TUBE CPU PCB.
Corrective action: Check the distance between the pulse
plate and the optical sensor on the Stereo PCB. Check the
communication between the Stereo PCB, the Clarity Shelf
CPU Interface PCB, and the TUBE CPU PCB.
Cause: When tilt movement calibration is performed center
limit is not active when calibration drive is started. You can
view the signals using the diagnostic display.
Corrective action: Check operation of the tilt limit sensors.
204 Anode motor drive failure. Cause: Incorrect anode stator resistance. A fault in the
tubehead internal stator winding or its wiring.
Corrective action: Check the winding resistances through
the 32-way connector, after you have removed the tube
power supply. Check also the condition of the tubehead
connector and its mating connector in the Tube Power
Supply.
Cause: Fault in anode motor drive circuitry.
Corrective action: Replace Tube CPU PCB, Tube Power
Supply or Tubehead. Try replacing parts in this order.
205 kV not rising. Cause: Tube voltage has not reached 15 kV in time.
Corrective action: See error 207 - kV too low.
206 mA not rising. Cause: Tube current has not reached 75% of the target
current level in time.
Corrective action: See error 208 - mA too low.

207 kV too low. Cause: The tube voltage is sampled periodically (by the
TUBE CPU) and if the actual, measured kV value is below
the setting this error message appears.
Corrective action: Check that the incoming mains voltage
does not drop below 187 Vrms during the exposure. Try to
perform the filament pre-heating voltage calibration.
If the error occurs constantly, replace the Tube CPU PCB,
the Tube Power Supply, and/or the tubehead (replace the
parts in this order).
Cause: PFC not working.
Corrective action: Replace Base Power PCB.
208 mA too low. Cause: The tube current is sampled periodically (by the
TUBE CPU) and if the actual mA value is lower than the
setting, this error message appears. An open circuit inside
the tubehead in the filament circuit may also cause this
error.
Corrective action: Perform the filament pre-heating voltage
calibration. Follow the tube filament voltage in the display.
If the display is stuck close to 0 V, replace the power
supply. Check the filament resistances (<0.5 ohm) through
the 32-way tubehead connector (refer to the schematics).
Check the mA feedback resistance through this same
connector.
209 kV too high. Cause: This condition is monitored (by the TUBE CPU)
during the whole exposure. If the anode voltage rises
above 40 kV, the exposure is stopped immediately and this
error message appears. One reason may be a partial X-ray
tube arcing (current spikes can cause the voltage
regulating electronic servo to overshoot). This kind of
arching can occur now and then without a particular
reason, and should be considered as a normal
phenomenon.
Corrective action: Close the error message and check that
the unit works correctly.
Cause: A bad galvanic contact between the Tube Power
Supply heat sink surface (the small rectangular surfaces
under the power supply bottom) and the mating tubehead
cast surfaces may also cause this error.
Corrective action: Make sure that the surfaces are totally
clean and grease-free, and that the power supply is
tightened firmly to the tubehead (but not too tight).

210 mA too high. Cause: The tube current is sampled periodically (by the
TUBE CPU) and if the actual, measured mA value is above
the setting, this error message appears. An incorrect
filament preheating voltage may also cause this error.
Corrective action: Perform the filament pre-heating voltage
calibration. Follow the tube filament voltage. If the display
is stuck to over 6.0V, replace the power supply. Check the
filament resistances (<0.5 ohm) through the 32-way
tubehead connector (refer to the schematics) and replace
the tubehead if necessary.
211 kV drop detected. Cause: This condition is monitored (by the TUBE CPU)
during the whole exposure. If the voltage suddenly drops
more that 6 kV below the actual setting, the exposure is
aborted and this error message appears.
Corrective action: One reason may be the X-ray tube
arching (in this case, a knocking sound can be heard).
Perform the same corrective actions as in Error 209.
212 Filament voltage not settled. Cause: The tube filament voltage is sampled periodically
(by the TUBE CPU) and if the actual, measured filament
voltage differs from the required, this error message
appears. The filament power supply (inside the Tube
Power Supply) may be faulty, or there may be a problem in
the filament feedback signals.
Corrective action: Performing the filament pre-heating
voltage calibration to recalibrate the filament voltages may
help. Check the tube filament voltage in the display. If the
display is stuck to over 6.0V, replace the Tube Power
Supply. The filament pre-heating voltage is displayed
during the calibration in the display.
213 Filament voltage over range. Cause: The tube filament voltage is sampled periodically
(by the TUBE CPU) and if the actual, measured filament
voltage differs from the required, this error message
appears. The filament power supply (inside the Tube
Power Supply) may be faulty, or there may be a problem in
the filament feedback signals.
Corrective action: Performing the filament pre-heating
voltage calibration to recalibrate the filament voltages may
help. Check the tube filament voltage in the display. If the
display is stuck to over 6.0V, replace the Tube Power
Supply. The filament pre-heating voltage is displayed
during the calibration in the display.
214 Bias voltage not settled. Cause: Fault in Tube Power Supply.
Corrective action: Replace Tube Power Supply.
215 Exposure time too long. Cause: Exposure pulse exceeds maximum pulse time.
Corrective action: Replace Tube Power Supply.

216 kV feedback open. Cause: There is an open circuit in the kV feedback signal
from the tubehead to the Tube CPU PCB. When the
feedback signal is open-circuited, the Tube CPU prevents
all exposures (both in normal and in service mode) to
ensure tubehead safety.
Corrective action: Check the condition of the 32-way
tubehead connector and the mating one in the Tube Power
Supply. Remove the power supply and measure the kV
feedback resistance at the 32-way tubehead connector
(refer to the schematics). If you cannot find the problem,
replace the Tube CPU PCB, the Tube Power Supply or the
tubehead (replace the parts in this order).
217 mA feedback open. Cause: There is an open circuit in the mA feedback signal
from the tubehead to the Tube CPU PCB. When the
feedback signal is open-circuited, the Tube CPU prevents
all exposures (both in normal and in service mode) to
ensure tubehead safety.
Supply. Remove the power supply and measure the mA
feedback resistance at the 32-way tubehead connector
(refer to he schematics). If you cannot find the problem,
replace the Tube CPU PCB, the Tube Power Supply or the
tubehead (replace the parts in this order).
218 Filament feedback open. Cause: There is an open circuit in the filament voltage
feedback from the tubehead to the Tube CPU PCB. When
the feedback signal is open circuited, the Tube CPU
prevents all exposures (both in normal and in service
mode) to ensure the safety of the tubehead.
Supply. Remove the power supply and measure the
filament feedback resistance at the 32-way tubehead
connector (refer to the schematics). If you cannot find the
problem, replace the Tube CPU PCB, the Tube Power
Supply, and/or the tubehead (replace the parts in this
order).
219 Tube head temperature Cause: See error 220.
sensor short circuit. Corrective action: If the problem does not disappear by
disconnecting the sensor wire from the Tubehead interface
PCB, check the cables, or replace the Tube CPU PCB if
necessary.
220 Tube head temperature Cause: All exposures are inhibited by the TUBE CPU
sensor open. during this error situation. The temperature of the tubehead
is measured by the TUBE CPU using a sensor at the rear
of the tubehead. The sensor is a NTC resistor and it has a
nominal resistance of 1k+ at 25 °C.
Corrective action: Check the cable and the connector from
the temperature sensor to the Tubehead interface PCB,
and/or the connector and the cables from the Tubehead
interface PCB to the Tube Power Supply. The sensor can
be verified with an ohm meter. The other wire of the sensor
is connected to the chassis ground (at the rear of the
tubehead cast). Check that this wire is not loose or open.

221 Generator temperature Cause: All exposures are inhibited by the Tube CPU during
sensor short circuit. this error situation. The temperature of the heatsink inside
the Tube Power Supply is measured by the Tube CPU with
a similar sensor as the tubehead temperature (see Error
219 and 220). This sensor is located inside the Tube
Power Supply and cannot be replaced.
Corrective action: Replace the Tube CPU PCB or the Tube
Power Supply (replace the parts in this order).
222 Generator temperature Cause: See error 221.
sensor open. Corrective action: Replace the Tube CPU PCB or the Tube
Power Supply (replace the parts in this order).
223 15V supply voltage level Cause: The analog circuitry in the Tube CPU board needs
failure. proper ±15 V voltages to operate.
Corrective action: Turn off the X-ray unit for at least 30
seconds and turn it back on. If the problem still occurs,
replace the Tube CPU PCB. If this does not help, then
replace the Tube Power Supply.
224 Grid position error. Cause: This error indicates missing steps in the stepper
motor that controls the Bucky grid movement. If the grid is
totally jammed or the sensors are faulty, this error
message is generated.
Corrective action: Check that the grid movement operates
properly. The grid plate should not hit either side of the
support mechanism during the back and forth movement.
Check Bucky motor and connections. Check Shelf CPU
Interface PCB and Tubehead Interface PCB.
226 Exposure sequence aborted. Cause: Exposure sequence aborted either internally or
requested externally.
Corrective action: Check if other error messages were
created simultaneously. Restart the unit.
227 Exposure sequence Cause: Exposure prepare or pulse phase abnormally
exception. terminated.
Corrective action: Check if other error messages were
created simultaneously. Restart the unit.
301 Rotation motor pulses no Cause: There are pulses from the rotation sensor even if
drive. you have not commanded the C-arm to rotate.
Corrective action: If the C-arm starts to rotate immediately
after turning on the power, check that the connectors at the
Rear Interface PCB are not cross connected (some of
them have the same pin count). This may happen
especially after servicing the X-ray unit when the Rear
interface PCB has been removed.
If the C-arm still rotates by itself, replace the Rotation drive
PCB.
If the C-arm does not rotate, and this error appears, check
the motor rotation sensor signal to make sure that there
are no faulty pulses. Check the connections. Replace the
Rotation drive PCB or the Rear CPU PCB.

302 Rotation motor timeout. Cause: The pulses from the rotation sensor of the C-arm
motor do not reach the Rear CPU.
Note: The motor contains a self-resetting circuit breaker
that operates if the motor becomes too hot. Allow the
motor to cool down before you continue to troubleshoot.
Corrective action: If the motor does not rotate: Check if
there is a mechanical obstruction. Check the condition of
the motor and the cables going to the Rotation drive PCB.
Check the connections. Check the cables from the
Rotation drive PCB to the Rear Interface PCB. Replace the
Rotation drive PCB if necessary.
If the motor rotates: Check the rotation sensor wire from
the motor to the Rear Interface PCB. The motor rotation
sensor may be faulty.
303 Lift motor pulses no drive. Cause: There are pulses from the lift motor rotation sensor
even the motor is not commanded.
Corrective action: If the motor is running by itself, replace
the Base Power PCB.
If the motor is not running by itself, check the lift motor
rotation sensor and its connections, and the connections
going from the Base Power PCB through Base Interface
PCB to the Rear Interface PCB.
304 Lift motor timeout. Cause: No pulses from lift motor rotation detector, or the
motor does not rotate even if commanded.
Note: The motor contains a self-resetting circuit breaker
that operates if the motor becomes too hot. Allow the
motor to cool down before you continue to troubleshoot.
Corrective action: Check the condition of the cables and
connections between the Base Power PCB, Base Interface
PCB and the Rear Interface PCB.
If the motor does not rotate: Check if there is a mechanical
obstruction. Check the condition of the motor and the
cables going to the Base Power PCB. Check the motor
connections.
If the motor rotates: Check the rotation sensor wires from
the motor to the Rear Interface PCB. The motor rotation
sensor may be faulty.
305 Compression motor timeout. Cause: Compression motor overcurrent.
Corrective action: Check wiring to compression motor.
Check if the motor is short-circuited.
401 Filter drive failure. Cause: The filter driving mechanism inside the collimator
assembly does not reach its limit sensor or the sensor
signal is missing. The sensor is located inside the
collimator.
Corrective action: View the sensor signal using the
diagnostic display. If the error appears continuously
replace collimator.
402 Mirror drive failure. Cause: The mirror driving mechanism inside the collimator
signal is missing.
Corrective action: Close the error message and check if
If the error appears continuously replace collimator.

403 Lamp drive failure. Cause: The lamp driving mechanism inside the collimator
signal is missing.
the unit works correctly. If the error appears continuously
replace collimator.
404 Collimator left drive failure. Cause: The collimator driving mechanism inside the
collimator assembly does not reach its limit sensor or the
sensor signal is missing.
405 Collimator right drive failure. Cause: The collimator driving mechanism inside the
406 Collimator front drive failure. Cause: The collimator driving mechanism inside the
407 Collimator rear left drive Cause: The collimator driving mechanism inside the
failure. collimator assembly does not reach its limit sensor or the
408 Collimator rear right drive Cause: The collimator driving mechanism inside the
failure. collimator assembly does not reach its limit sensor or the
501 MaxView upper drive failure. Cause: Limit sensor not activated or active continuously.
Corrective action: Check cabling, MaxView module
connections, Shelf Interface PCB and Shelf CPU PCB.
Replace MaxView module.
Cause: Obstruction inside the MaxView Module.
Remove obstruction inside the MaxView module.
502 MaxView lower drive failure. Cause: Limit sensor not activated or active continuously.
Corrective action: Check cabling, MaxView module
connections, Shelf Interface PCB and Shelf CPU PCB.
Replace MaxView module.
Cause: Obstruction inside the MaxView Module.
Remove obstruction inside the MaxView module.

3.2 Mammography unit notifications
CODE MESSAGE CORRECTIVE ACTION

5000 Safety switch is open. Close the safety switch to proceed.
5001 Unable to change view. Release compression to change view.
5002 Unable to change view. End procedure and release compression to change
view.
5003 Unable to adjust compression. End procedure to enable patient positioning.
5004 Unable to adjust rotation. End procedure to enable patient positioning.
5005 Unable to adjust height. End procedure to enable patient positioning.
5006 Foot pedal is already pressed. Release the foot pedal before selecting view.
5007 Unable to remove guide unit. End procedure and release compression first.
5008 Guide unit must be removed first. Please attach the stereo platform to resume use.
5009 Needle guide reset failed. Press OK to retry.
5010 Multiple foot pedals are Check that nothing is pressing the switches. If not, the
simultaneously pressed. most probable cause is a faulty foot control cable or
switch.
5011 Movement is not allowed with Reduce compression to allow movement.
compression force more than 5
daN.
5012 Unable to use AEC. Choose manual exposure values or acquire scout
image in AEC mode first to enable AEC use for stereo
images.
5013 Unable to drive rotation. Adjust height upwards.
5014 Unable to use AEC without Attach compression adapter.
motorized compression.
5015 Drive stopped. Select view to complete drive.
5100 Unable to drive SideAccess. Select view first.
5101 SideAccess drive active. Return C-arm to centre position.
5102 Unable to drive SideAccess. SideAccess is not available with selected view angle.
5104 Unable to drive SideAccess. SideAccess is not enabled.
5200 Unsuitable imaging equipment Replace equipment or select imaging mode from top
combination. menu for assistance.
5201 Unable to compress. Select view first.
5202 Unable to compress. Activate imaging mode first.
5301 Tube head has overheated. Wait for the temperature to drop below 60 degrees.
5302 Generator has overheated. Wait for the temperature to drop below 70 degrees.


Chapter C: PREVENTIVE
MAINTENANCE
1 SYSTEM MAINTENANCE
1.1 Cleaning
CAUTION
When disinfecting the X-ray unit surfaces, always disconnect the X-ray unit from the
mains. The X-ray unit must not be exposed to gaseous disinfectants or explosive
anaesthetics.
CAUTION
Never spill any liquids on the X-ray unit.
For more information on the cleaning processes and the recommended cleaning agents
for Planmed Clarity parts, see the Planmed Clarity 2D/3D user’s manual (publication
number 20009437).
1.2 Operator’s maintenance schedule

The following inspections must be performed on a monthly basis by the responsible
operator of the X-ray unit.
Exposure indicators
Confirm that both exposure indicators lights turn on in the control panels and the remote
control for the length of the exposure. Check also the optional external indicator, if one is
attached.
Audible exposure indicator

Confirm that the exposure indicator tone comes on for the length of the exposure. A lower
tone should be heard during the 2–5 second start-up period (anode acceleration and pre-
heating of the filament) and a higher tone during the actual exposure when radiation is
generated.
Exposure switch
Confirm that the exposure switch requires continuous activation to maintain the exposure.
Releasing the exposure switch during the radiation should produce the Error 124
Exposure switch released during exposure message on the displays (clear it by pressing
the OK button). Make a visual check that the exposure switch spiral cable is not damaged.

Chapter C: PREVENTIVE MAINTENANCE
Labels
Check that no labels (compression paddles, shields of the X-ray unit) are detached or
worn and that they are all legible.
Full Field Flex AEC performance

Take an exposure of your test phantom and compare the image with older images on the
database. If necessary, perform the Full Field Flex AEC calibration procedure, see section
3 "FULL FIELD FLEX AEC CALIBRATION PROCEDURE" on page 103.
Compression force display

Put a soft spacer between the paddle and a scale. Compress with the front edge of the
paddle a small scale and compare the value with the compression display in the X-ray
unit. The deviation should be less than ± 15%.

Chapter C: PREVENTIVE MAINTENANCE 2 PREVENTIVE MAINTENANCE CHECKS
2 PREVENTIVE MAINTENANCE CHECKS

NOTE
These checks must be performed by a qualified service technician during the installation of
the X-ray unit and thereafter on an annual basis. Failure to do so could affect image quality
or patient safety.
NOTE
To avoid direct exposure to the detector when performing repeated exposures for
measurements that do not require AEC functionality and interpretation of images, place a
steel or lead plate on the Bucky to cover the whole active area.
2.1 Preventive maintenance schedule

The preventive maintenance inspection must be scheduled by the user of the X-ray unit to
be performed by an authorized service representative.
The checks described in this chapter must be performed once a year.
2.2 Calibration and verification of the instruments

The used measurement and test instruments must be calibrated once a year by
authorized calibration officials to ensure long-term accuracy.
2.3 Determining Half Value Layer (HVL / beam quality)
Instruments and tools required

• Aluminium sheets (8 pcs) 0.1 x 100 x 100 mm (type 1100 alloy)
• Radiation meter calibrated at mammographic X-ray
beam energies (calibration factor constant
within ±1% over the HVL range of 0.2 to
0.8 mm Al)
• Steel or lead plate
Preparations for the measurements

1. Place the radiation meter sensor 4.5 cm above the Bucky, 5 cm in from the chest wall
edge and centred on the X-ray field.
2. Remove the compression paddle.
3. Place a steel or lead plate on the Bucky to cover the whole active area in order to
avoid direct exposure to the detector.
Measurement procedure
1. Set the exposure parameters: manual mode, 30 kV, 100 mAs, Ag-filter and large
focus.
2. Take an exposure.
3. Make sure that the radiation meter sensor is fully exposed.
4. Record the radiation meter reading (as E0).
5. Add 0.2 mm of Al between then X-ray tubehead and the radiation meter.
6. Take an exposure and record the radiation meter reading.

2 PREVENTIVE MAINTENANCE CHECKS Chapter C: PREVENTIVE MAINTENANCE
7. Repeat the step as described above with additional 0.1 mm Al sheets between the X-
ray tube and the radiation meter, recording the radiation meter reading each time until
the reading is less than one-half the unattenuated exposure reading (E0).
8. Remove all aluminium sheets, take an exposure and record the reading.
9. If the result of this repeated E0 measurement differs by more than 2% from the
exposure E0 measured in Step 4, repeat the measurement sequence.
10. Repeat Steps 1.– 9. for Rh-filter.
Data analysis and interpretation

To calculate the HVL value by logarithmic interpolation use the following notation and
procedure. Denote the direct exposure reading without aluminium as E0.
• Divide this value in half and find the two exposure readings and added aluminium
thicknesses that bracket the E0 /2 exposure.
• Let Ea be the exposure reading that is just greater than one half of E0 and ta be the
corresponding aluminium thickness.
• Let Eb be the exposure reading that is just less than one half of E0 and tb be the
corresponding aluminium thickness.
NOTE
Ea will be greater than Eb while ta will be smaller than tb.
The HVL value may be computed using the following formula:

tb ln[2Ea/Eo] - ta ln[2Eb/Eo]
HVL =
ln[Ea/Eb]
where the HVL will be given in the same units as ta and tb, usually in millimetres of
aluminium.
Rejection limit
At a given kVp setting in the mammographic kilovolt range, the measured HVL (the
compression paddle not in place) must be greater than the following value:
kVp
HVL ≥ (in units of mm aluminum)
100
For example, if the nominal tube potential is 28 kVp, the HVL value must be equal or
exceed 0.28 mm of aluminium. If the measured HVL is below this limit at any kVp setting,
service personnel should be contacted to check whether appropriate filtration is in place.
If the HVL value is excessive, both subject contrast and image contrast will be reduced. It
is recommended that the HVL is within a constant value (C) of the minimum acceptable
HVL:
kVp
HVL < + C (in mm of aluminum)
100
where C = 0.36 mm Al for W/Rh and C = 0.46 mm Al for W/Ag.
NOTE
These HVL upper limits are based on rhodium filter thickness of 25 µm or less.

Excessive HVL violates no standards, but it should prompt a check by service personnel to
ensure that the filtration is correctly installed.

2.4 Checking X-ray tube radiation output
When to calibrate
This calibration must be performed:
• During the annual maintenance
• If tube head or tube CPU has been replaced

• Radiation meter Calibrated at mammographic X-ray
0.8 mm Al)
Preparations
1. Remove the compression paddle and attach Bucky.
2. Place the radiation meter sensor 4.5 cm above the Bucky, 5 cm from the chest wall
edge and centred on the X-ray field.
Clarity_Xray_TubeRadiationOutput.eps
4,5 cm
5 cm
1. Enter the SERVICE & CONFIGURATION menu, see section 2.1 "Entering and exiting
SERVICE & CONFIGURATION menu" on page 48.

2. Select Calibration and Exposure tab.
3. Select the measurement in the Radiation output field.

The measurement must be made for all four options (one at the time):
• large focus with Rh-filter (30 kV, 100 mAs)
• large focus with Ag-filter (30 kV, 100 mAs)
• small focus with Rh-filter (30 kV, 100 mAs)
• small focus with Ag-filter (30 kV, 100 mAs)
The exposure parameters (30 kV, 100 mAs) are automatically set by the system.
4. Take the exposure.
Make sure that the radiation meter sensor is fully exposed.
5. Record the radiation meter reading in µGy.
Divide the reading by the mAs used, so that as a result you will get µGy/mAs.
NOTE
Depending on the radiation meter model, the radiation reading unit may vary. Do the
conversion accordingly to get the value in µGy/mAs.
6. Check if the calculated value (=radiation output) differs from the value which is
already in the memory of the X-ray unit.
If a difference is noticed, set the new value into the correct field. Use + (plus) and -
(minus) buttons to modify the values in the screen.

7. Make the same measurement for the other options listed in Step 3.
8. When all measurements are done, click Save button to store the values.
Rejection limit
Compare the radiation reading to the reading that was measured when the equipment was
first taken into use. If the current value is less than 70% of the initial value, the tube
radiation output has lowered so much that it is recommended to replace the X-ray tube.
If there are no earlier readings available, the radiation reading should exceed 30 µGy/mAs
for small focal spot and 35 µGy/mAs for large focus with W target and Ag filter.
2.5 Image quality evaluation

• Planmed Clarity Manager software
• Manual: Planmed Clarity Quality Control Manual (20009709)
• Mammographic Accreditation Phantom RMI, Model 156
• Manual: Mammographic Accreditation Phantom RMI 156 (by Gammex)
Preparations for the measurement

1. Drive the Planmed FFDM X-ray unit to the CC position, refer to Clarity Manager
User’s Manual.
1. Follow the instructions given in the Mammographic Accreditation Phantom RMI 156
manual.
2. Verify that the phantom is centred and 1 cm in from the chest wall edge.
3. Repeat the procedure for both focal spots.
Rejection limit
The score is calculated as instructed in the Mammographic Accreditation Phantom RMI
156 manual. A minimum score of 4 for fibres, 3 for specks, and 4 for masses should be
achieved to meet the ACR criteria.
WARNING
The operator must protect himself against radiation which will be generated when
taking the exposure.

Chapter C: PREVENTIVE MAINTENANCE 3 OTHER PREVENTIVE CHECKS
3 OTHER PREVENTIVE CHECKS
3.1 Verifying compression force measurement

• A scale
1. Place the scale on the Bucky and a soft pad (thickness 5–10 cm) between the front
edge of the upper compression paddle and the scale.
2. Run the upper compression paddle down until the scale shows 15 kg.
3. Check that the X-ray unit shows the same value within ± 1 kg (14...16 kg). If not, see
section 2.1 "Calibrating compression force" on page 82 for the calibration instructions.
3.2 Verifying filament pre-heating voltages

It is recommended that the filament pre-heating voltages are calibrated (they cannot be
measured) once a year to compensate for any changes in the X-ray tube parameters. See
section 2.4 "Calibration X-ray tube filament pre-heating voltage" on page 93 for
instructions on how to perform this.
3.3 Verifying anode voltage (kV)

There are two different measurement procedures that can be used:
• 3.3.1 "Measurement procedure using Mult-O-Meter" on page 75
• 3.3.2 "Measurement procedure using digital multimeter" on page 76
In both procedures, place a steel or lead plate on the Bucky to cover the whole active area
in order to avoid direct exposure to the detector.
3.3.1 Measurement procedure using Mult-O-Meter

• Mult-O-Meter For example, Unfors Model Xi
1. Place the Mult-O-Meter (kVp meter) on the breast support table so that it is centered
and 5 cm in from the chest wall edge.
2. Set the Mult-O-Meter to the correct target / filter combination and with paddle / without
paddle setting in accordance with the Mult-O-Meter user’s manual.
3. Set the exposure parameters: manual mode, 27 kV, 50 mAs, Rh-Filter (60 µm Rh),
large focus.
4. Make sure that the Automatic kV selection and the AEC modes are not selected.
5. Take an exposure and read the kVp value from the display of the Mult-O-Meter.
6. Use the calibration coefficients to determine the actual kVp and record it.
7. Repeat the procedure using 31 kV and 35 kV.

3 OTHER PREVENTIVE CHECKS Chapter C: PREVENTIVE MAINTENANCE
3.3.2 Measurement procedure using digital multimeter

• Digital multimeter For example, FLUKE Model 187
• Feedback measuring cable Order No. 07827773
1. Turn off the X-ray unit.
2. Remove C-arm upper cover, C-arm back cover and C-arm lower cover, see section
1.3 "C-arm covers" on page 134.
3. Remove the tube head power supply cover.
4. Connect the Feedback measuring cable to the P3 connector on the TUBE CPU Stand
PCB (109-10-15). The board is located in the rear end of the power supply (see figure
below).
A
C
mA+
C
mA-
kV+
kV-
A
P3
connector
mA
mA/kV
connector
kV
black
red
plug
plug
5. Connect the cable to the multimeter: the red plug to the Vand the black plug to the
COM connections (see figure above).
6. Connect the mA/kV connector to the kV cable connector (see figure above).
7. Switch the multimeter to the DC voltage range.
8. Turn the X-ray unit on.
CAUTION
The X-ray unit may be damaged if an exposure is made when the multimeter is
on the resistance range.
9. Set the exposure parameters: manual mode, 23 kV, 200 mAs, large focus.
10. Make sure that the Automatic kV selection and the AEC modes are NOT selected.

11. Take an exposure and record the multimeter value during exposure. The right kV
value is calculated from the measured voltage value by multiplying it by 8950, for
example:
2.289 V x 8950 = 20.5 kV
12. Repeat the measurement with the following values:
• 28 kV 200 mAs large focus
• 35 kV 200 mAs large focus
Rejection limits
All measured kV values must be within ± 1.5 kV of the pre-selected kV values.
3.4 Verifying tube current (mA) and exposure time

• Radiation meter calibrated at mammographic X-ray
0.8 mm Al)
• Digital multimeter For example, FLUKE Model 187
• Feedback monitoring cable Order No. 07827773
1. Turn off the X-ray unit.
2. Place the radiation meter to the Bucky so that the meter is in the centre of the front
edge and 5 cm in from the chest wall edge.
4. Remove C-arm upper cover, C-arm back cover and C-arm lower cover, see section
1.3 "C-arm covers" on page 134.
5. Remove the tube head power supply cover.

6. Connect the Feedback measuring cable to the P3 connector on the TUBE CPU Stand
PCB (109-10-15). The board is located in the rear end of the power supply (see figure
below).
A
C
mA+
C
mA-
kV+
kV-
A
P3
connector
mA
mA/kV
connector
kV
black
red
plug
plug
7. Connect the cable to the multimeter: the red plug to the Vand the black plug to the
COM connections (see figure above).
8. Connect the mA/kV connector to the mA cable connector (see figure above).
9. Switch the multimeter to the resistance range and record the mA feedback line
resistance value (R) (nominal 34 ).
10. Switch the multimeter to the DC voltage range.
11. Set the radiation meter to register the exposure time.
12. Turn on the X-ray unit.
CAUTION
The X-ray unit may be damaged if an exposure is made when the multimeter is on
the resistance range.
13. Set the exposure parameters: manual mode, 28 kV, 50 mAs, small focus.
14. Make sure that the Automatic kV Selection and the AEC modes are NOT selected.
15. Take an exposure and record the multimeter voltage value (U) during exposure.
16. Record also the time reading on the display of radiation meter.
17. The right current (I) value is calculated from the measured voltage value by dividing it
by the measured resistance value, for example:
R = 34.2 
U = 341 mV
I = U/R = 341 mV/34.2  = 9.98 mA
18. The corresponding mAs value is calculated by multiplying the mA value by the
exposure time value.

19. Repeat the measurement with the following values.

Table 2: Measurement values
kV mAs Maximum tube current for Exposure time and focus size
set kV/mAs combination
28 kV 50 mAs 39 mA 1.28 sec. small focus (above)
35 kV 50 mAs 31 mA 1.61 sec. small focus
28 kV 140 mAs 114 mA 1.23 sec. large focus
35 kV 140 mAs 91 mA 1.54 sec. large focus
Rejection limits
• All measured mA values must be within ± 4 mA of the pre-selected mA values when
the large focus is used and within ±2 mA when the small focus is used
• All measured times must be within ±4% of the pre-selected times
3.5 Verifying X-ray beam alignment

Verify the alignment of the X-ray beam according to the instructions given in Chapter D:
"ADJUSTMENT & CALIBRATION" on page 81.
Rejection limits
The X-ray beam must reach the inner edges of the X-ray field borders of the X-ray beam
alignment tool. The accepted total overlap is 2% of the distance between the X-ray source
and the detector.
This distance is 650 mm and the total overlap may be 13 mm. The overlaps on the both
sides are added up and the sum may be this 13 mm. That is, if the overlap on the right side
is 5 mm, the overlap on the left side may be max. 8 mm.
3.6 Verifying light field beam illumination

• Lux-meter For example, Delta Ohm Model HD8366
1. Remove the additional light limiter in the measuring device so that full field size of the
equipment is used.
2. Divide the light field area into four equal quadrants.

3. Measure the illuminance of the light localiser from the centre of each quadrant.
4. Record these readings.
Rejection limits
All measured illumination values must be more than 160 lux.
3.7 Verifying light field alignment

Verify the alignment of the light fields (large focus and small focus).
Rejection limits
The maximum allowed misalignment of the edges of the light field with the respective
edges of the X-ray field is 13 mm (including the measurement of the front, the back and
both side edges).
3.8 Measuring light field contrast

• Lux-meter For example, Delta Ohm Model HD8366
1. Switch on the light field.
2. Starting at the chest wall side, measure the illumination 3 millimetres from the edge of
the light field towards the centre of the field, and the illumination 3 millimetres from the
edge of the light field away from the centre of the field.
3. Record these results.
4. Switch off the light field and measure the ambient light (that is, light illumination in the
room).
5. Subtract the ambient light from the values measured above.
6. Divide these results and record the contrast ratio on the same sheet.
7. Repeat the above procedure for all other three edges.
Rejection limits
The minimum contrast ratio on the edges of the light field is 4.
3.9 Verifying electrical safety
Protective earth
Measure with an Ohm meter from the mains plug ground terminal against any bare metal
part in the X-ray unit, the display must be under 0.2 ohms.
External cable conditions

Check visually the mains cable, the remote control cable, the spiral cable to the exposure
switch and the foot control cables.

Chapter D: ADJUSTMENT &
CALIBRATION
1 REGIONAL AND INITIAL SET-UPS BEFORE

USING X-RAY UNIT
The X-ray unit is tested and adjusted at the factory to comply with various regional safety
requirements. Parameters that are controlled by software (stored in the X-ray unit's
internal memory) should be verified before the X-ray unit is taken into normal operation
since they may vary from region to region. In addition, after replacing CPU(s) or other
electrical units, the regional set-ups must be verified and some calibrations have to be
performed.
The adjustments that must be performed always before using the X-ray unit for the first
time are listed below. There are also a number of other adjustments that affect the
behaviour of the X-ray unit. These are preset at the factory to suitable values. Therefore,
no re-adjustment is normally needed.
Maximum allowed exposure time / mAs

The maximum allowed exposure time can be either 5 seconds, 6 seconds or 300 mAs
(milliampereseconds).
To adjust maximum exposure time, see section 2.7 "Adjusting exposure settings" on
page 97.
Maximum allowed breast compression force

The X-ray unit is capable of compressing the breast up to 25 daN (20 daN is the
factory default).
To adjust maximum compression force, see instructions in Planmed Clarity User
manual.
Enable/disable height-control during compression

The X-ray unit is delivered so that the height control is inoperative if the breast is
being compressed.
Enable/disable C-arm rotation without foot control activation

In some countries regulations require that the motorised movement of the C-arm is
not allowed without a continuous activation of a (foot) control switch.
To adjust rotation safety settings, see section 2.6 "Adjusting movement settings" on
page 96.
Correct time and date

The time and date are automatically set when the Clarity Manager is connected to the
X-ray unit.

2 ADVANCED ADJUSTMENTS Chapter D: ADJUSTMENT & CALIBRATION
2 ADVANCED ADJUSTMENTS
Some advanced adjustments and functions can be performed only in the SERVICE &
CONFIGURATION menu. In order to perform the adjustments and calibrations described
in this section you must first enter the SERVICE & CONFIGURATION menu.
CAUTION
The SERVICE & CONFIGURATION menu is intended only for an experienced ser -
vice technician, and should not be entered by the user under normal circumstances.
2.1 Calibrating compression force
When to calibrate
• If the compression mechanism has been replaced
• If any malfunctions observed in compression function

• Compression calibration gauge (20002069)
Calibration
1. Drive C-arm to upright position.
3. Select Calibration vertical tab and Compression force horizontal tab.

Chapter D: ADJUSTMENT & CALIBRATION 2 ADVANCED ADJUSTMENTS
4. Attach Bucky and Large Paddle to the mammography unit.
5. Touch Start Calibration button.
6. Place compressor calibration gauge symmetrically, as shown in the touch screen and
manually compress to 15 daN.
7. Touch the Save Calibration button.

8. When the calibration is ready a Calibrated green box appears to the screen.
2.2 Calibrating paddle offsets
When to calibrate
• When a new compression paddle is taken into use
• If compression mechanism has been replaced

• Compression calibration gauge (20002069)
Calibration
NOTE
The C-arm drive button is not visible if the C-arm is already in upright position.

3. Select Calibration vertical tab and Paddle Offsets horizontal tab.
4. Touch Drive C-arm button.
5. Attach compression paddle and related platform.

6. Place compression calibration gauge symmetrically, as shown in the touch screen.
7. Touch Start Calibration button to start the calibration process.

8. When the calibration is ready a Calibrated green box appears to the screen.

2.3 Calibrating movements
2.3.1 Calibrating tilt
When to calibrate
• Together with the side access mechanism maintenance
• If any malfunction observed in movements
• If any motor or compression mechanism has been replaced

No special tools or instruments are needed for the calibration.
3. Select Calibration vertical tab and Movements horizontal tab.
4. In the Tilt box, touch Release Brake button to release tilt brake to begin calibration.
5. Center the breast support table mechanism manually in the middle position of the C-
arm.

Tip! Placing a spirit level on the cassette table makes the adjustment easier.
6. When ready, touch the Calibrate button.
When the calibration is ready a Calibrated green box appears to the screen.
2.3.2 Calibrating lift
When to calibrate

4. In the Lift box, touch Start Calibration button.

When the calibration is ready, a green Calibrated box displays.

2.3.3 Calibrating rotation
When to calibrate
• Together with the side access mechanism maintenance

3. In the Rotation box, touch Start Calibration button.

4. Drive C-arm upwards to allow calibration and touch Start Calibration button.
5. Adjust the tilt to 0 degrees with - (minus) and + (plus) buttons, and touch the Continue
Calibration button.

2.3.4 Calibrating compression
When to calibrate

3. Remove any paddles.

4. In the Compression box, touch Start Calibration button.

2.4 Calibration X-ray tube filament pre-heating voltage
WARNING
Some X-ray radiation is emitted during this calibration (duration from 60 to 120 sec -
onds) even though the light field beam mirror is not driven out of the X-ray beam.
Always shield yourself against radiation.
When to calibrate
• If tube head, tube CPU or power supply has been replaced

Calibration
1. Prepare acquisition mode in Clarity Manager:
a. Start Clarity Manager with service level profile.
b. In the Home screen, click the main selection button.
c. Select Acquisition and click the Enable Acquisition button.
2. In the X-ray unit, enter the SERVICE & CONFIGURATION menu, see section 2.1
"Entering and exiting SERVICE & CONFIGURATION menu" on page 48.
3. Select Calibration vertical tab and Filament preheat horizontal tab.
4. Touch the Start Calibration button.
5. Press and hold the exposure button down for the entire duration of the exposure.

2.5 Changing unit to and from transportation mode
2.5.1 Changing unit to transportation mode

The unit should never be transported if it is not in the transportation position. In the
transportation position, the unit runs the C-arm as low as possible and turns the tubehead
against the floor. This ensures that the centre point of gravity is as low as possible.
2. Select Transportationn vertical tab.
3. Touch the Play button.

The X-ray unit drives to the transportation mode.
4. When the unit is in the transportation mode, the following screen appears.

Before moving the X-ray unit, lower the C-arm to the locking knob and shut down the
X-ray unit.
NOTE
In fault situations, it is possible to drive the unit to locking knob in diagnostics mode.
2.5.2 Changing unit from transportation mode to operating mode
CAUTION
Ensure that there is enough free space around the X-ray unit so that the C-arm
does not hit any obstacles during the movement. To stop the C-arm in an emer -
gency situation, press the emergency STOP button or the compression foot con -
trols.
1. Switch on the X-ray unit.

After short time of self tests, the unit control panel displays automatically the
SERVICE & CONFIGURATION menu in Transportation tab and requires PIN code.
2. After entering the PIN code, the following screen appears.
3. To activate the normal use mode, touch the Play button.

2.6 Adjusting movement settings

2. Select Configuration vertical tab and Drives horizontal tab
3. Change the settings, if needed, according to the descriptions below.

View movement
• Automatic: C-arm moves automatically
• Continuous activation: All C-arm movements need foot pedal activation
SideAccess movement
The selected option defines how the Side access patient positioning feature is
operated:
• Automatic: Side access movement is fully automatic.
• Manual return: Side access switch must be kept pressed only when the C-arm
returns to the 0 position.
• Manual: Side access rotation is done by keeping the Side access button pressed
for the whole duration of the movement.
• Not in use: Side access feature is not in use.
Compression release movement
• Automatic: The compression paddle is automatically driven to the highest
position after the exposure.
• Continuous activation (only foot pedal use): No automatic release. The breast
must be released manually with foot pedal, or by driving the compression paddle
upwards using the controls.
4. Touch Save button to store the settings.

2.7 Adjusting exposure settings

2. Select the Configuration vertical tab and the Exposure horizontal tab.
3. Change the settings, if needed, according to the descriptions below.

Maximum mA
• Tick the Enable 80 mA limit check box to enable the maximum mA value to 80.
Time accuracy test mode
• Tick the Enable check box to activate the time accuracy test mode.
Filter change thickness
• Use minus (-) and plus (+) buttons to change filter thickness value, in case the
filter is changed.
Exposure time
• Choose the desired maximum exposure time from the Maximum drop down
menu.
AEC type
• AEC (default): Normal AEC function.
• AEC with locked kV: AEC with kV locked.

2.8 Updating maintenance information

2. Select the Maintenance vertical tab.
In the Maintenance tab you can reset maintenance counters as well as modify serial
numbers for replaced parts.
2.9 Calibrating exposure radiation output

For more information on calibrating exposure radiation output, see section 2.4 "Checking
X-ray tube radiation output" on page 72.
2.10 Adjusting diagnostic settings

2. Select the Diagnostic vertical tab.
In the diagnostic vertical tab you can view internal signals (on the Signals tab), drive
individual motors and calibrate MaxView modules.

• Beam
Drive different motors in the

collimator and switch the light on
and off.
NOTE: The rear left and rear right

motors are connected to same
collimation plate. Driving the
motors unevenly can result in the
collimator motors jamming.
The Limit reading displays if the optical limit sensor is active or inactive inside the
collimator.
• Rotation
Drive the rotation motor and

display state of limit sensors.
Ref: Reference sensor

Low: Lower limit sensor (Should
not be activated when driving to
180 degrees)
High: Upper limit sensor
• Lift
Drive the lift motor and display the

state of limit sensor.
Ref: Reference sensor

High: Upper limit sensor
Low: Lower limit sensor
• Compression
Drive compression motors and

display information from sensors
inside compression mechanism.
High: Upper limit sensor for

compression mechanism
Low: Lower limit sensor for
compression mechanism
Force: Display compression force in daN
Force ADC: Signal from force sensor after AD-conversion
Force offset output: Value for force sensor offset
Thickness: Thickness with compensation for the connected paddle
Thickness raw: Thickness without any compensation for paddle
Thickness ADC: Signal value from potentiometer after AD conversion

• Tilt
Adjust the tilt position in 15-degree

increments or use the arrow
buttons.
SLIM1: Active when 15°

recognised in C-arm slot sensor
PCB
ZERO: Active when 0° recognised
in C-arm slot sensor PCB
SLIM2: Active when -15° angle between support table and C-arm recognised in
C-arm slot sensor PCB
SPLS1: Active when rotation disk in Stereo PCB recognised as black by SPLS1
optical sensor
SPLS2: Active when disk in Stereo PCB recognised as black by SPLS2 optical
sensor
30: Active when angle between support table and C-arm is 30°
-15: Active when angle between support table and C-arm is -15°
-30: Active when angle between support table and C-arm is -30°
NOTE: *If SLIM2 and ZERO are both active angle is -30°. If SLIM1 and ZERO are
both active angle is 30°.
• MaxView
Arrow buttons drive upper or lower

module in or out.
Calibrate: Calibrate position for

MaxView upper or lower module
Load: Drive to position where
MaxView sheets can be inserted
Eject: Release the MaxView sheet
Limit: Active when limit sensor inside the module is recognised
• Grid
Start: Drive the exposure sequence

with grid motor
Stop: Stop driving the grid motor
Calibrate: Calibrates the grid
motor movement
Limit: Displays if the limit sensor
is active

• Imaging equipment
Displays which paddle and

platform is recognised by Paddle
Sensor PCB and the Clarity Bucky
Sensor PCB.
2.11 Adjusting acquisition settings

2. Select the Acquisition vertical tab.
In the Acquisition tab you can make exposures with or without the AWS connected.
When making exposures in acquisition mode, some automatic safety processes are
disabled. For example, there is no automatic filter selection when compressing.
The screen has the following function buttons:

• Clarity set to Online/Offline
In online mode you need to enable acquisition from Clarity

Manager Calibration->Acquisition tab in order to take images.
AEC and AEC with locked kV can be used in online mode.
In offline mode you can make exposures with manual values without sending the
image to AWS. Always remember to cover the detector with Detector shield
(20010164) in order to avoid ghosting when taking exposures in offline mode. It is
not possible to AEC or AEC locked kV modes if offline is selected.
• Focus size selection and filter selection

• Manual collimation
• Drive compression mechanism up
• Selection of imaging mode
For more information on the functions, see the Planmed Clarity 2D/3D User’s Manual
(publication number 20009437).

Chapter D: ADJUSTMENT & CALIBRATION 3 FULL FIELD FLEX AEC CALIBRATION PROCEDURE
3 FULL FIELD FLEX AEC CALIBRATION

PROCEDURE
To ensure proper Full Field Flex AEC performance the calibration procedure described
below should be carried for all used modes: Examination, Magnification and Stereo
Biopsy.
When to calibrate
• Prior to taking the Planmed Clarity mammography X-ray unit into use
• If tube head, tube CPU, collimator, power supply or sensor has been replaced

• 4 pcs Clarity AEC phantom plate (part number 20009748)
WARNING
Protect yourself from radiation when taking an exposure.
1. Attach Bucky, platform and paddle according to the calibration to be made, see the list
below:
• Prepulse, Examination:
- Bucky
- large compression paddle
• Prepulse, Magnification:
- magnification platform
- compression paddle (bigger one, if two in use)
• Prepulse, Stereo Biopsy:
- stereo biopsy platform
- no any paddle
2. Place 4 pieces of Clarity AEC phantom plate on the Bucky, the magnification platform
or the stereo biopsy platform (which is in use for the calibration).
3. On the X-ray unit’s screen, select R-CC view.
Compress to 45 mm in Examination and Magnification calibration.

3 FULL FIELD FLEX AEC CALIBRATION PROCEDURE Chapter D: ADJUSTMENT & CALIBRATION
4. Turn the key on the interface adapter to Remote mode. The key is located in the
bottom of the lower shelf, see the figure below.
Clarity_key.eps
Remote - Device mode message should appear on the X-ray unit’s display.
5. Start Clarity Manager with service level profile.
6. In the Home screen, click the main selection button, click Calibration icon and select
Prepulse tab.
7. Select the Calibration Mode.
WARNING
Protect yourself from radiation when the exposures are taken.
8. Click Start Calibration button.

9. Confirm that the setup is correct.

Chapter D: ADJUSTMENT & CALIBRATION 3 FULL FIELD FLEX AEC CALIBRATION PROCEDURE
The following images show different prepulse calibration notifications for examination
and magnification, and stereo biopsy setup.
Click OK for each notification.

The X-ray field size calibration starts. During the calibration multiple exposures are
taken automatically.
During the calibration, the status information of the calibration progress is shown on
the Clarity Manager display.
10. Wait until the Calibration completed successfully message is displayed.
11. Turn the key on the interface adapter to Normal mode.
Clarity_key2.eps
For more information on adjusting the Full Field Flex AEC settings, see section 2.1.5
"Imaging / AEC" on page 168.

4 2D CALIBRATIONS Chapter D: ADJUSTMENT & CALIBRATION
4 2D CALIBRATIONS
For instructions on the 2D calibration of Planmed Clarity, refer to the 2D calibration
instructions in the Planmed Clarity 2D/3D User’s Manual (publication number 20009437).
The instructions include flat field (2D) calibration instructions for examination and
magnification calibrations.
5 3D CALIBRATIONS
For instructions on the 3D calibration of Planmed Clarity, refer to the tomosynthesis
calibration instructions in the Planmed Clarity 2D/3D User’s Manual (publication number
20009437).
The instructions include background calibration and flat field (3D) calibration instructions
for different kV and platform configurations.

Chapter D: ADJUSTMENT & CALIBRATION 6 CALIBRATING AND VERIFYING X-RAY FIELD SIZE
6 CALIBRATING AND VERIFYING X-RAY FIELD

SIZE
Follow the instructions in these sections for:
• Section 6.1 "Calibrating X-ray field size" on page 108
• If the collimator assembly has been loosened or detached
• If the tube head, collimator or detector has been replaced
• If the X-ray field is misdirected for some other reason
• Section 6.2 "Verifying X-ray field size" on page 110
• For quality control purposes
• After calibrating the X-ray field size
• When any adjustments to the X-ray field settings have been made
• Section 6.3 "Troubleshooting failed X-ray field verification" on page 122
• For troubleshooting the failed X-ray field size verification
• Section 6.3.3 "Acceptable X-ray field size" on page 123
• For more information on the X-ray field size tolerances
NOTE
Follow these instructions together with the on-line instruction on the X-ray unit screens and
on the Clarity Manager views.

6 CALIBRATING AND VERIFYING X-RAY FIELD SIZE Chapter D: ADJUSTMENT & CALIBRATION
6.1 Calibrating X-ray field size
When to calibrate
• If the collimator assembly has been loosened or detached
• If tube head, collimator or sensor has been replaced
• If the X-ray field is misdirected for some other reason

Calibration procedure
1. Attach Bucky and remove compression paddle from the X-ray unit.
2. In the X-ray unit’s screen, select R-CC view.
3. Turn the key on the interface adapter to Remote mode. The key is located in the
Clarity_key.eps
Remote - Device mode message should appear on the X-ray unit’s display.
Field Size tab.

WARNING
7. Click OK button in the following dialog.
The X-ray field size calibration starts. During the calibration multiple exposures are
taken automatically.
During the calibration, the status information of the calibration progress is shown on
the Clarity Manager display.
8. Wait until the Calibration completed successfully message is displayed.
Clarity_key2.eps
10. Verify the X-ray field size, see instructions in the section 6.2 "Verifying X-ray field
size" on page 110.

6.2 Verifying X-ray field size

This section gives the instructions on how to verify the X-ray field size, separately for the
large focus (includes the small focus verification) and for the tomosynthesis modes.
The X-ray field is verified by using two different phantoms (see the Tools required section
below).
WARNING
When to verify
• For quality control purposes
• After calibrating the X-ray field size
• When any adjustments to the X-ray field settings have been made

• Left-Right phantom
• Front-Rear phantom

NOTE
Test exposure images are stored in C:\Planmed\test_images\ folder. If you need to store
the images with measurements included, acquire them into a study. Always clear ‘Apply
Enhancement’ check box before adjusting histogram, when acquiring images to a study.
6.2.1 Verifying X-ray field size for large focus

1. Attach Bucky and remove face guard and compression paddle from the X-ray unit.
2. In the X-ray unit’s screen, select R-MLO view.
4. Select Acquisition vertical tab.
5. Check that the large focus in the Focus size field is selected.
In the X-ray unit's screen, manually select 30 kV and 20 mAs.

Acquisition tab.
8. Click the Enable Acquisition button.

9. Attach the Front-Rear phantom between the collimator plates as shown in the figure
below.
• It is easier to put first the phantom’s rear side towards the rear collimator plate
and then fit the phantom’s front side towards the front plate
• The phantom edges contain small grooves; place the phantom so that the
collimator plates fit into the grooves
• Locate the phantom in the middle of the collimator plates
WARNING
10. Take the exposure by pressing and holding down the exposure button for the entire
duration of exposure.

11. Adjust the levels of the image according to the following steps:
a. Using the Draw Rectangle tool, draw a representation of the signal values. The
rectangle’s dimensions do not matter.
The tool automatically generates the Min, Max, Avg and StDev values (in white in
the example above) for the rectangle.
b. Take the Avg value. In the example above, the Avg value is 2216.6.
c. Multiply the Avg value by 0.8. In the example above, 2216.6 x 0.8 = 1773.28.
The result is therefore approximately 1773.
d. Reduce the value by 200 (1773 - 200 = 1573 in the example) and feed it into the
Adjust Levels window’s minimum value field.
e. Increase the value by 200 (1773 + 200 = 1973 in the example) and feed it into the
Adjust Levels window’s maximum value field.

f. Click OK.
12. Measure the visible part of the phantom base on the both sides, in the front and rear
edges.
• Use the measurement tool in the Clarity Manager

• Use zoom, move and other tools in the Clarity Manager to get accurate
measurements
• Always measure up to the edge of the image
• In the acceptable image the measurement tolerances are as follows:
Front: 18,5 mm - 22,5 mm
Rear: 16,0 mm - 23,7 mm
NOTE
If the tolerances are not met, see more instructions in section 6.3 "Troubleshooting
failed X-ray field verification" on page 122.
13. Remove the phantom from the collimator.

14. Attach the Left-Right phantom between the collimator’s plates as shown in the figure
below.
WARNING

f. Click OK.

17. Measure the visible part of the phantom base on the both sides, in the left and right
edges.

measurements
• In the acceptable image the measurement tolerances are as follows:
Left and right: 17,4 mm - 23,2 mm
NOTE
NOTE
When all measurements (front, rear, left and right) are within the tolerances, the X-ray field
size is successfully verified.
6.2.2 Verifying X-ray field size for tomosynthesis

1. Attach tomosynthesis platform and tomosynthesis compression paddle.
The tomosynthesis imaging mode is activated.
2. In the X-ray unit’s screen, select R-CC view.

3. Attach the Front-Rear phantom between the collimator plates as shown in the figure
below.
• It is easier to put first the phantom’s rear side towards the rear collimator plate
and then fit the phantom’s front side towards the front plate
4. Compress paddle to less than 12 cm height, to get the X-ray unit to Ready-state.
5. In the X-ray unit’s screen, manually select 30 kV and 32 mAs.
Acquisition tab.
8. Click Enable Acquisition button.
WARNING
10. In the Clarity Manager, browse through all frames and check visually that no frames
have collimator plates visible in the image.
11. Select 2 - 3 frames (e.g. 1st, 7th and 15th) for verifying the front edge of the
tomosynthesis X-ray field, close all other frame images from the Clarity Manager
view.


f. Click OK.
13. Measure the visible part of the phantom base on the both sides in the front edge.

measurements

• Measure the visible part starting from the middle of the blurred area, see the
figure below
• In the acceptable image the measurement tolerance is 18.5 mm - 22.5 mm

14. Measure all other selected frames, start again from the Step 11.
NOTE
NOTE
When all measurements are within the tolerance, the X-ray field size for tomosynthesis is
successfully verified.

6.3 Troubleshooting failed X-ray field verification

In some rare cases, the automatically made X-ray field calibration is not able to set the X-
ray field size so that it meets the tolerances (see section 6.3.3 "Acceptable X-ray field size"
on page 123), in this case, follow the instructions below to troubleshoot.
6.3.1 If X-ray field verification fails

Follow the instructions below to troubleshoot the problem with the X-ray field size.
1. Carry out the X-ray field calibration as described in section 6.1 "Calibrating X-ray field
size" on page 108, and verify again the X-ray field size as described in section 6.2
"Verifying X-ray field size" on page 110.
2. Check the physical placement of the collimator, for example if the collimator has bent
or damaged during transportation.
3. If the problem persists, contact your local service representative.
6.3.2 Manually adjust X-ray field size

If some manual changes are desired to make to the X-ray field size, follow the instructions
below.
WARNING
These instructions are meant only for experienced and qualified service technician
user. These settings can affect image quality or patient safety.
NOTE
The following procedure under the Field Size tool tab causes a physical reconfiguration in
the collimator. Any changes in collimation are recommended to be done by running the field
size calibration as instructed in section 6.1 "Calibrating X-ray field size" on page 108. Any
adjustments performed in Field Size Tool are reset if field size calibration is run.
2. Select Calibration vertical tab and Field Size Tool horizontal tab.
Focus size
Rear edge
Left edge Right edge
Front edge
a. Focus size: Select correct focus size.

b. Change the desired setting (front, rear, left or right) depending on which edge of
the X-ray field needs to be corrected. On the rear edge, there are two separate
settings:
- the +/plus button moves collimator plate towards center narrowing aperture
- the -/minus button moves collimator plate outwards widening aperture
c. Click Save button after changes are made.
3. Always verify the manual adjustments, see instructions in section 6.2 "Verifying X-ray
field size" on page 110.
6.3.3 Acceptable X-ray field size

The aim of adjusting the X-ray field is to set the X-ray field front, rear, left and right edges
properly in relation to the sensor active area. The X-ray field in each edge should be
slightly over (offset) the sensor active area edges, as shown in the figure below.
Clarity_Xray_Field_intro_1.eps
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X-ray field edges
rear: 0 - 8 mm
left: 0 - 6 mm
right: 0 - 6 mm
sensor active
area
front: 0 - 4 mm
Table 3: Acceptable offset ranges
Sensor edge Offset acceptable range

Front (chest wall) 0 mm - 4 mm
Rear 0 mm - 8 mm
Left 0 mm - 6 mm
Right 0 mm - 6 mm

7 ADJUSTING LIGHT FIELD Chapter D: ADJUSTMENT & CALIBRATION
7 ADJUSTING LIGHT FIELD

This section gives the instructions on how to check and adjust the light field.
Standards define the size and the position of the X-ray field and the light field in relation to
each other and to the X-ray source.
The light field is adjusted for both, small and large focuses and checked by taking test
exposures.
Small focus is mainly used with magnification platform. However, the light field
adjustments are made with Bucky. If the requirements are fulfilled with the Bucky, they are
always fulfilled with the magnification platform.
WARNING
When to calibrate
• If tube head or collimator has been replaced

• 4 small metal objects, for example, coins/washers (Ø 14 mm - 20 mm)
7.1 Adjusting large focus and small light fields

Carry out the following procedure for both the small and large focuses.
1. Drive the C-arm to the upright position.
2. Remove face guard from the X-ray unit.
3. Attach Bucky to the X-ray unit.
4. In the Clarity X-ray unit touch screen, select Calibration vertical tab and Field size
horizontal tab.
5. Select large or small focus (depending on which light field you are adjusting) in the
Focus size field in Acquisition screen.
6. Set the lights on.

Chapter D: ADJUSTMENT & CALIBRATION 7 ADJUSTING LIGHT FIELD
7. Place 4 similar metal objects to each corner of the light field.

sensor
light field
metal objects
• The outer edge of the objects should be in the middle of the shady edge area of
the light field (which is approx. 3 mm wide)
Acquisition tab.
10. Click Enable Acquisition button.

11. Take a test exposure.
12. Analyse the image and adjust the light field accordingly.
The optimal situation is reached when the difference between the X-ray field and the
light field is as small as possible on the four edges.
The maximum allowed misalignment of the edges of the light field with the respective
edges of the X-ray field is 13 mm (including the measurement of the front, the back
and both side edges).
NOTE
Take into account that the comparison is made to the actual X-ray field size, that is, the
X-ray field edges are more wide than the sensor active area, see more in section 6.3.3
"Acceptable X-ray field size" on page 123.

13. Adjust the light field, if necessary.

a. Remove C-arm upper cover, see section 1.3.1 "Removing C-arm upper cover" on
page 134.

Chapter D: ADJUSTMENT & CALIBRATION 7 ADJUSTING LIGHT FIELD
b. Adjust the light field:

To adjust the light field left-right direction, turn the adjustment screw located in
the C-arm as shown in the figure below.
To adjust the light front-rear direction, loosen the holding screw inside the
collimator with an Allen key size 2.
Adjust the front-rear direction with the flat head screw accessible from the front of

the collimator, and then tighten the holding screw.
c. Take a new test exposure to verify the changes.

14. Repeat the above adjustment procedure until you reach an acceptable result for both
the large focus and the small focus light fields.

Chapter E: PARTS REPLACEMENT
AND REPAIR
WARNING
The X-ray unit contains hazardous voltages. Always disconnect the X-ray unit from
the mains by removing the plug from the wall outlet, and wait for 2 minutes before
starting to remove covers.

1 REMOVING COVERS
To be able to access the inner parts some covers must be removed in a particular order.
All the covers are shown in the figure below. In the texts and descriptions of this manual
the covers are referred to by the names shown in the figure below.
6
10
11
1 7
12
2
13
14
3
4 15
9 Clarity_covers.eps
1 Telescopic column back cover 6 Hood 11 C-arm upper cover

2 Telescopic column front cover 7 C-arm back cover 12 C-arm lower cover
3 Stationary column back cover 8 Base rear cover 13 Beam window frame
4 Stationary column front cover 9 Side base cover (2 pcs) 14 C-arm vertical cover
5 Emergency stop knob 10 C-arm upper cover nut 15 Base front plug (2 pcs)
NOTE
The following instructions only describe the removing of the covers. To reattach the covers,
follow the steps in reverse order.

1.1 Base covers
1.1.1 Removing side base covers

1. Remove the side base covers by lifting them up carefully.
Rem_base_covers.eps
1.1.2 Removing rear base cover

1. Turn off the X-ray unit and unplug it from the mains.
2. Loosen the four screws of the base rear cover (1, two located the side near the On/Off
switch and at the other end of the cover) and lift the cover up (2).
co
v er.
ep
s
3
ck_
_ ba
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ba
m_
Re
3. Detach the grounding cable from the base rear cover and remove the cover (3).

1.2 Column covers
1.2.1 Removing hood

2. Remove the two cover plugs (1) and unscrew the two attachment screws (2).
1
2
3. Remove the handle (3) by lifting it upwards.

Note the two washers (4) when lifting the handle.
4. Carefully lift up the hood (5) and detach the emergency switch cable from the
connector (6).

1.2.2 Removing telescopic column back cover
NOTE
Remove first the hood, see section 1.2.1 "Removing hood" on page 132.
2. Lift and carefully pull backwards the telescopic column back cover (1).
s
ep
er.
ov
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a ck
n _b
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Re
3. Detach the grounding cable (2) from the telescopic column back cover.
1.2.3 Removing stationary column back cover
NOTE
Remove first the telescopic column back cover, see section 1.2.2 "Removing telescopic
column back cover" on page 133, and the rear base cover, see section 1.1.2 "Removing
rear base cover" on page 131.
2. Lift and carefully pull backwards the stationary column back cover (1).
Rem_column_back_cover2.eps

3. Detach the grounding cable (2) from the telescopic column back cover.
1.3 C-arm covers
1.3.1 Removing C-arm upper cover

2. Remove chin guard from the X-ray unit.
3. Unscrew the two screws (1) connecting the C-arm upper cover through the beam
window frame.
REM_C-arm-top_cover.eps
4. Unscrew the C-arm upper cover nut (2) on the top of the cover.
5. Lift up to detach the C-arm upper cover.

1.3.2 Removing C-arm back cover
NOTE
Remove first the C-arm upper cover, see section 1.3.1 "Removing C-arm upper cover" on
page 134.
2. Detach the C-arm back cover by pulling it backwards.
Rem_c-arm_back_cover.eps

1.3.3 Removing C-arm lower cover
NOTE
Remove first the C-arm back cover, see section 1.3.2 "Removing C-arm back cover" on
page 135.
2. Turn the breast support table system (1) to the left (or right) to make it easier to
remove the C-arm lower cover.
2 3
Rem_c-arm_bottom_cover.eps
3. Detach both TWO C-arm control button cables (2 and 3) from the connectors.
4. Unscrew the four attachment screws (4) of the beam window frame and remove the
beam window frame.
Rem_c-arm_bottom_cover2.eps
5. Slide the C-arm lower cover (5) off.

Chapter E: PARTS REPLACEMENT AND REPAIR 2 UPDATING X-RAY UNIT SOFTWARE
2 UPDATING X-RAY UNIT SOFTWARE

The X-ray unit software can be updated by the Planmed Clarity Manager, follow the steps
below to update the X-ray unit software.
NOTE
If updating Planmed Clarity software from a version older than the previous release, you
must also install the updates between your current version and the latest release.
NOTE
If the Planmed Clarity and Planmed Clarity Manager software versions are not compatible,
Planmed Clarity Manager will otherwise work but does not allow exposures to be taken.
NOTE
Before starting, the new Planmed Clarity software zip file must be available e.g. on a USB
flash drive connected to the Planmed Clarity Manager USB port.
1. Turn the key on the interface adapter to SW update mode. The key is located in the
Clarity_key_SWupdate.eps
2. Switch on or restart the X-ray unit.

4. In the Home screen, click the main selection button and click Service icon.
5. Click Update Clarity software button.

6. Browse and select the Planemed Clarity software zip-file (e.g.
ClarityEmbedded_1.1.0.0.zip), and click Open button.

2 UPDATING X-RAY UNIT SOFTWARE Chapter E: PARTS REPLACEMENT AND REPAIR
7. Check that the desired software version is shown in the Update SW: field.
8. Click the Update SW button.

Wait until the software update is finished. The update can take a few minutes.
NOTE
Pressing the Force SW Update button updates all software versions even if the
versions are already up to date. Pressing the Update SW button updates only those
software versions that are not up to date.
From the Update Status field you can follow the update progress.
9. When the update process has finished, check that the new software version is shown
in the Clarity SW: field, and click OK button.

Chapter E: PARTS REPLACEMENT AND REPAIR 2 UPDATING X-RAY UNIT SOFTWARE
Clarity_key2.eps
11. Restart the X-ray unit.

12. Retart the Clarity Manager.

3 REPLACING MAIN FUSES Chapter E: PARTS REPLACEMENT AND REPAIR
3 REPLACING MAIN FUSES
WARNING
Always replace a fuse with the same type and rating. Failure to do so may risk
patient and operator safety.
NOTE
When checking the condition of a fuse, always use an ohmmeter or equivalent to check the
conductivity. Do not perform a sight inspection only, as a fuse may be broken even if it looks
intact.
2. Remove the right side base cover, see section 1.1 "Base covers" on page 131.
3. Change the fuses (2 x 15 AT/250 V (slow blow) 6.3 x 32 mm) as shown in the figure
below.
IB S
S
S E
E
U S
L
F U
F
S E E N
T E D IB E TIO
V
F S U
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50
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E
T S P S E O
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IB
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A L N L Q P
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S
5
A N M R R E
S 1
U
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4. Attach the removed side cover.

Chapter E: PARTS REPLACEMENT AND REPAIR 4 REPLACING BATTERIES & PCBs
4 REPLACING BATTERIES & PCBs
4.1 Replacing RTC PCB battery

2. Turn the breast support table system (1) upside down.
Turn_C-arm_upsidedown.eps
3. Place a screwdriver though the hole as shown in the figure below.
4. Use the screwdriver to lift and pull the C-arm bottom cover simultaneously.

4 REPLACING BATTERIES & PCBs Chapter E: PARTS REPLACEMENT AND REPAIR
5. When the cover has moved to the position shown in the image below, lift it away.
6. Remove the old battery from its socket on the RTC PCB and place a new 20 mm
Lithium Coin Cell Battery 3V (type CR2032) to the battery socket.
7. Attach removed covers in reverse order.

Chapter E: PARTS REPLACEMENT AND REPAIR 4 REPLACING BATTERIES & PCBs
RTC PCB electrical layout

5 REPLACING POWER CORD Chapter E: PARTS REPLACEMENT AND REPAIR
5 REPLACING POWER CORD

1. Turn off the X-ray unit and unplug the power supply cord from the mains.
2. Remove the right side base cover, see section 1.1 "Base covers" on page 131.
3. Unscrew the four attachment screws of the fuse panel.
4. Carefully lift up and turn the fuse panel to reach the power cord terminal block.
5. Unscrew the phase (L) and neutral (N) wire terminal screw and detach the wires.
Detach the protective earth wire (yellow-green) from the fuse holder block. Detach the
ferrite from protective earth wire.

Chapter E: PARTS REPLACEMENT AND REPAIR 5 REPLACING POWER CORD
6. Open the strain-relief connector with 17 mm open-end wrench and remove the old
power cord.
7. Attach new power cord in reverse order and attach the removed covers.

6 REPLACING MECHANICAL PARTS Chapter E: PARTS REPLACEMENT AND REPAIR
6 REPLACING MECHANICAL PARTS
6.1 Replacing gas spring
CAUTION
The C-arm must be in upright (CC) position before replacing the gas spring.
WARNING
Do not switch the unit off. Be careful not to touch any electronic parts during assem -
bly.
1. Remove hood, telescopic column back cover and stationary column back cover, see
section 1.2 "Column covers" on page 132.
2. Drive the X-ray unit to the upright position.
3. Remove the locking washers at both ends of the gas spring assembly.
Washers
Locking ring
Nut shaft
Gas spring grease cup
Locking ring
Washers
NOTE
There are two washers in the upper attachment axle and two washers in the lower
attachment axle. Use these washers with the new gas spring.
4. Gently pull out the gas spring.

5. Install a new gas spring.
6. Rotate the C-arm from one end to the other.
If the gas spring makes a loud noise when you rotate the C-arm, make sure that the
gas spring felt ring is properly greased.
To grease the gas spring felt ring:
a. Remove the gas spring grease cup from the lower end of the gas spring.
b. Remove the felt ring from the bottom of the cup.
c. Grease the felt ring properly with Klüber Polylub GLY 801.

Chapter E: PARTS REPLACEMENT AND REPAIR 6 REPLACING MECHANICAL PARTS
d. Place the grease ring back into the cup. Make sure that the grease does not stain
the inner surface of the cup (otherwise the cup will not stay in place).
e. Attach the grease cup back to the gas spring.
7. Check that there is vaseline in the upper attachment nut shaft as well as in both
attachment axles.
8. Insert vaseline to the attachment axles and the nut shaft, if necessary.
9. Insert the washers and the gas spring to the axle.
10. Secure the gas spring to its position with the locking rings.
11. Attach removed covers.
6.2 Replacing detector
Removing detector
1. Remove the platform so that you can see the detector.
2. Remove the plastic cover on top the Lower MaxView Module. Open the two finger
screws (1 in the image below.) so that metal cover can be removed in front of the
Lower MaxView Module.
3. Remove the two screws that hold the Lower MaxView Module in place (2 in the image
below).

4. Open and remove the two screws on both sides of the Lower MaxView Module.
5. Remove the Lower MaxView Module together with the metal cover.
6. Remove the two screws that keep the metal plate assembly behind the detector in
place and remove the metal plate.

7. Detach the cable from the Platform recognition PCB and the grounding cable from the
shelf grounding point.
8. Remove the four screws holding the detector in place.
9. Carefully lift the detector so that the cables connected to the detector from below can
be detached.

10. Remove the frame from the detector.
Replacing detector
1. Place the replacement detector carefully upside down on a soft surface and put the
frame on top of the detector.
2. Attach the frame to the detector with four screws so that you can still move the frame
a little. You can also attach the cables seen in picture to the detector.

3. Slide the detector into the examination platform and lock it in place.
4. Push the detector towards the front side of the platform. While pushing the detector,
tighten the four screws that attach the detector to the frame.
5. Remove the detector from the platform.

6. Place the detector on the Planmed Clarity shelf and attach the cables between the
detector and Planmed Clarity.
7. Attach the detector from the frame with four screws to the shelf.
8. Attach all the remaining parts to Planmed Clarity in the reverse order to their
detachment.
Installing detector files on Acquisition Workstation (AWS)

The detector is shipped with an installation disc with detector-specific files that need to be
installed on the AWS.
1. Boot the AWS normally
When Clarity Manager has started, close Clarity Manager.
2. Browse to C:\IMAGERs and move the content of that folder to a secure place, for
example, the Documents folder.
3. Insert the detector installation disc and install the content to the IMAGERs folder.
4. When the installation has finished, start Clarity Manager and login in as a System
Administrator.

5. Open the Service view and click the button on the right side of Detector serial number.
6. Browse to C:\IMAGERs folder and select the folder that is named with the detector
serial number that is currently installed to Planmed Clarity.
7. Save changes and restart Clarity Manager.
Verifying installation
After Clarity Manger has started, verify that the connection between detector and Clarity
manager is working.
If the detector temperature is seen in the lower right hand corner of the Clarity manager,
then the connection is established properly.
Changing license file

After the detector change, the license file needs to be updated. The license file is sent
together with the detector.
1. Copy the license file to the AWS and start the Clarity Manager.
2. Log in as a System Administrator and open the Support view.
3. Click the Install License button and browse to the location where the license file was
copied.
4. Select the license file and click Open.
5. Restart Clarity Manager and check that no notice messages about Not Licensed for
Clinical use are visible.
Calibrating detector
After the detector has been changed, all the detector calibrations (Field size, 2D, 3D and
Prepulse) and quality tests must be performed before starting any patient studies.
Verify the X-ray field size as instructed in section 6.1 "Calibrating X-ray field size" on page
108.

6.3 Replacing lifting motor assembly
WARNING
The X-ray unit contains hazardous voltages. While servicing internal parts, always
disconnect the X-ray unit from the mains (if possible) by removing the plug from the
wall outlet, and wait for 2 minutes before touching any electrical parts.
The lifting motor assembly includes a

three-phase lift motor, a pulse sensor
and worm screw nut assembly.
1. Turn off the unit and remove the
rear base cover, hood, telescopic
column back cover and stationary
column back cover.
For more information, see section 1
"REMOVING COVERS" on page
130.
2. Turn on the unit and place a
wooden rod on the base.

3. Drive the telescopic column carefully to hit the rod.
4. Turn off Clarity.

5. Unscrew the lift motor worm screw nut's screws.

6. Unscrew the lift motor worm screw and nut.
7. Remove the base power cover and all the connections for the lift motor.
8. Take the motor out. Put the new lift motor assembly in reverse order.
9. Calibrate the lift motor from the user interface.
a. Go to Service & Configuration.
b. Choose the Calibration tab and Movements.
c. Press Start Calibration under Lift.

Chapter F: PLANMED CLARITY
MANAGER
This chapter describes how to install and configure the Planmed Clarity Manager software.
The Planmed Clarity Manager application serves as user interface for both the Planmed
Clarity 2D/3D Full Field Digital Mammography (FFDM) and to the Digital Breast
Tomosynthesis (DBT) systems.
Instructions in this chapter are intended to be used by the system administrator who has
knowledge of the Microsoft® Windows® operating system. If you are not familiar with
Microsoft® Windows® operating systems please consult the appropriate Microsoft
documentation before using this manual.
Technical manual Planmed Clarity Manager 157

1 INSTALLING PLANMED CLARITY MANAGER
1.1 Computer settings
1.1.1 Date and number format

The Planmed Clarity Manager application uses the date format and number format
specified by your workstation’s regional settings. You should check your regional settings
to ensure that your workstation uses the most common date and number format used in
your region to avoid confusion. We also recommend that you set the workstation to
recognize four-digit years.
1.1.2 Checking regional settings

1. From the Task bar, click Start --> Control Panel.
2. In the Control Panel, click Region and Language.
3. Ensure that the most common language, number, and date settings for the region are
selected. The date style should include four-digit years.
4. Click Apply and OK.
5. In the Control Panel, click Date and Time.
6. Check that the date and time are correct.
7. Check that the appropriate time zone is selected.
8. Click Apply and OK, and close the Control Panel.
1.1.3 Windows user accounts

By default, one user account called “Planmed” has been defined. The password is clarity.
This user has been assigned administrator rights.
1.1.4 Security settings

Computer viruses can prevent the applications from working properly.
CAUTION
Make sure that the workstation is protected with firewall and an up to date anti-virus
software. If possible, isolate the workstation from the office network.
CAUTION
Do not install any other third party applications to the workstation except anti-virus
software.
NOTE
Real time scanning should be disabled. Daily system check should be scheduled to be
performed every night.
1.1.5 Automatic updates

Automatic Windows updates are disabled by Clarity Manager setup, as Planmed cannot
guarantee that the automatic updates would not affect the functionality of Clarity Manager.
Automatic Java updates have been disabled for the same reason.
158 Planmed Clarity Manager Technical manual

1.2 Installing Planmed Clarity Manager software
NOTE
Before installation the virus protection must be temporarily disabled.
The software applications and files needed in the installation procedures are delivered in
the Planmed Clarity Manager installation media.
1. Insert the Planmed Clarity Manger software installation media into the computer.
The following window opens.
2. Click Next to continue.

3. On the following window click Install.
4. The setup will now install Clarity Manager software and other necessary components
on your computer.
This will take approximately few minutes.
NOTE
If not already installed the following auxiliary programs will be installed on your
computer:
• Microsoft SQL 2008

• Windows Installer 4.5
• Microsoft NET Framework 3.5 Service Pack 1

• Windows PowerShell 1.0.

These programs may require restarting of the computer.
5. Follow the instructions carefully in order to successfully install the application and
allow restarts when required.
1.3 Software uninstalling/reinstalling

When you uninstalling or reinstalling the Planmed Clarity software, all of the application
files are removed including the application’s database and license files.
CAUTION
Be sure to back up any required patient and image data and license files before
uninstalling the software.
1.4 Licensing Planmed Clarity Manager

Send the serial number of your system and detector as well as your End user name and
city to the address:
[email protected]
Your Planmed representative will provide you with the ClarityManager.lic file, by e-
mail or on the CD.
Copy the file to the folder C:\Planmed\license or use Install license in the Support
window.
The licence becomes valid after the software has been restarted.2

1.5 Installing and activating 2D image processing licence

This chapter describes how to install and activate the 2D image processing license.
1. Plug in the green USB-dongle to free USB port on the computer.

2. Start the licence manager software:
a. Browse to the C:\Planmed\ClarityManager\ folder.
b. Double-click the ELicenseManager.bat file.
3. In the licence manager, check the serial number from the Security Info tab (see the
figure below).
4. Click Add License... button and select the license file corresponding the serial
number.
5. Activate the license, if the activation is successful, the following notice is displayed.
6. Click OK button and close the license manager.
1.6 Configuring AWS

Configure the AWS computer display in the ui.properties file located in the
C:\Planmed\ClarityManager folder.
• If you have a 1536 x 2048 resolution display, select screenType = 0
• If you have a 1080 x 1920 resolution display, select screenType = 1

2 CONFIGURING PLANMED CLARITY MANAGER Chapter F: PLANMED CLARITY MANAGER
2 CONFIGURING PLANMED CLARITY MANAGER
2.1 SERVICE & CONFIGURATION menu

To access the SERVICE & CONFIGURATION menu, follow the steps below.
2. In the Home screen, click the main selection button and click Service icon.
In all SERVICE & CONFIGURATION menu views the performed modifications are saved
by clicking Save button and the previous settings can be returned by clicking Restore
button.

Chapter F: PLANMED CLARITY MANAGER 2 CONFIGURING PLANMED CLARITY MANAGER
2.1.1 Imaging / Device
Clarity
• IP Address
Default -button sets the IP address to the default value of the Clarity X-ray unit.
Demo -button sets the IP address value to localhost. The demo mode can be used
e.g. for fine-tuning image enhancement settings.
• Device serial number
• Detector serial number
• Operating temperature (°C)
• Save raw images
This option should be used only for troubleshooting purposes for example if it is
suspected that the detector has been damaged. If this option is selected raw images
will be saved to folder:
C:\Planmed\temp_images
• Update Clarity software
CD/DVD Recording Device
NOTE
Normally no modifications are required.
CD/DVD recording device specific settings can also be selected during CD/DVD burning
process.
• Device Bus
• Default volume label
• Show maximum burning speed

To show the maximum burning speed in the user interface (16x for DVD, 48 for CD)
select the Show maximum burning speed option.
Some DVD/CD burning devices do not support the maximum burning speed. If this is
the case with your burning device uncheck this option.
Logging
The logging settings can be configured if problems occur when using the system.
• Logging level
Normally logging level should be set to 0.
• Log messages from Clarity -check box
Logs Clarity status information. This option should always be on.
2.1.2 Imaging / Quality Control
Exposure values for tests

These settings apply for those tests in which one exposure is required.
• kV and mAs
To modify kV or mAs value enter new values in the corresponding field.
• Filter
To modify the filter select the appropriate filter from the Filter drop-down menu by
clicking the arrow on the field at right.
Tests
• Test name / Scheduled
Click the drop-down menu on the field next to the test and select the appropriate
frequency for the test.

• Configure -button
Click the Configure on the field next to the test to configure Phantom test parameters.
Select the appropriate exposure mode, and to change Window width and level enter
the new values in the corresponding fields. When ready, click OK.
2.1.3 Imaging / Calibration
NOTE
Generally the calibration settings should not be changed. However, for troubleshooting
purposes it may be temporarily in order.
Calibration settings
• Delay start of calibration (hours:minutes)
• Delay between exposures (seconds)
• Number of stabilization exposures
• Filters (0=Ag, 1=Rh)
• Save temporary files -button
To modify the calibration settings, type the new time / value in the corresponding fields.
Examination
• Number of Exposures
• kV
• mAs
To modify the number of exposures, kV and mAs values type new values in the
corresponding fields.

Tomosynthesis, flat-field
• mAs
To modify the number of exposures and mAs values type new values in the corresponding
fields.
Tomosynthesis, background
• kV
• mAs
Magnification
• kV
• mAs
2.1.4 Imaging / Enhancement
Default Enhancement
• Contrast
• Brightness

• Sharpness
• Use legacy segmentation algorithm -button
To modify contrast, brightness or sharpness, enter new values in the corresponding fields.
Biopsy Enhancement
• Contrast
• Brightness
• Sharpness
Magnification Enhancement
• Contrast
• Brightness
• Sharpness
Spot Compression Enhancement

• Contrast
• Brightness
• Sharpness
Tomo Enhancement
• Parameter file
To change the tomo enhancement parameter file, click the button next to the Parameter
file field, and browse the desired parameter file.

2.1.5 Imaging / AEC
Calculation mode
• Calculation mode
• Absolute
By selecting Absolute, the AEC exposure parameters are counted according to
the number of areas configured in the Area count limit field, if those areas have
human tissue detected by the AEC. If human tissue is detected on less number of
areas, only those areas with detected human tissue are counted in.
• Percentage
By selecting Percentage, the AEC exposure parameters are counted by taking as
many areas with human tissue as needed to get the average glandular dose to
go below the value configured in the Glandularity limit % field. If the average
glandular dose does not go below the configured Glandularity limit %, all areas
are counted in.
• Glandularity limit %
See the description of the Calculation mode/Percentage above.
• Area count limit
See the description of the Calculation mode/Absolute above.

AEC curve and target signals

Values in these fields are for adjusting the prepulse kV value for different compression
thicknesses, and for adjusting the desired signal levels for different compression
thicknesses, that is, to control the dose level the patient receives.
From the drop-down Mode menu, select the mode:
• Examination (includes Spot Compression and Biopsy modes)
• Magnification 16.
• Magnification 1.8
• Stereo Biopsy
The adjustment tool for each of the above modes can be adjusted with a Filter (Rh or Ag)
and kV Voltage values in 9 different Thickness ranges. These 9 setting intervals are
defined by the AEC operating range of 0 - 120 mm, except for stereo biopsy which ranges
from 0 - 100 mm.
The MIN target count determines the left side of the thickness range, while the MAX target
determines the right side of the thickness. The target counts are calculated by
interpolating the MIN target and MAX target if they match the thickness listed in the middle
of the control interval.
The width of the adjustment slot can be changed by dragging the red ball horizontally.
The kV value of the adjustment range can be changed by dragging the blue ball vertically.
NOTE
If Planmed Clarity Manager is upgraded from a version older than 1.2, the old dosage
settings will not automatically update to the new tool. If you want to preserve the old values,
configure them with Planmed Clarity Manager 1.2 at the time of installation.
Nominal tomosynthesis exposure settings

Values in these fields are for adjusting the tomosynthesis exposure parameters.
The kV and mAs values are given in 10 mm scale. Between the 10 mm steps, the kV and
mAs values are defined with linear interpolation.
NOTE
The nominal values are calculated assuming a system with an X-ray tube output of 50 uGy/
mAs. Real exposure values can vary depending on the actual tube output, and need to be
adjusted to maintain dose consistency between Planmed Clarity units.

2.1.6 Imaging / Tomo
Reconstruction Parameters
• Pixel size
• Iterations
• Regularization
• Streak suppression
Reconstruction Padding
• Bottom
• Top
Reconstruction Grid
• Origin X
• Origin Y
• Origin Z
• Size X
• Size Y
Viewing
• Show volume visualizer
• Default slab thickness
• Default slab method

2.1.7 Imaging / Clarity Guide
Device parameters
• R*sin(alpha)
• R*cos(alpha)

2.1.8 Imaging / DICOM

In the DICOM tab you can make required configuration changes for communicating with
other DICOM enabled systems and define what information is sent to PACS with images.
Local
The local settings should be adjusted to suit the specific hospital environment and optional
printers and worklist.

In order to configure DICOM destinations the following information is needed from the
local network administrator.
• Institution Name
• Institution Address
• Department Name
• Station Name
• Scheduled AE Title
The scheduled AE title can generally be set to same as calling AE title.
• Calling AE Title
If there are several Planmed AWS workstations in the network the workstations
should have unique AE titles, for example PLANMED_AWS_1, PLANMED_AWS_2
etc. The default AE title is PLANMED_AWS_1.
• Local Port
Includes the SSL enabled check box. For more information, see section "Enabling
SSL layer" on page 174.
• Default Protocol Name
• Specific Character Set
To configure the character set click the Configure button, select the appropriate
character set(s) and click OK.
Remote
In the Remote field you can select, deselect, verify and configure (configuration applies to
Storage, Printer, Worklist and MPPS AEs) DICOM application entities. The verification can
be used to make sure the remote AE's are correctly configured and that the systems are
up and running.
AE titles, Port numbers and IP addresses for the needed DICOM services are:
• Storage AE
• Printer AE
• Query / Retrieve AE
• Worklist AE
• MPPS AE

The calling AE title for workstation (default AE title is PLANMED_AWS_1) is needed for
most of the services.
Other settings
In the Other settings field you can select, deselect and configure other DICOM settings.
• Modality Performed Procedure Step (MPPS) enabled
• Create new Series for each image
• Patient ID’s are unique (Social Security Number or equivalent)
• Maximum number of Storage retries
• DICOM Logging level (0=Errors only, 4=Detailed)
Enabling SSL layer

Secure Sockets Layer (SSL) technology allows secure communication between Planmed
Clarity Manager and PACS. SSL can only be used if PACS supports it. When SSL is
enabled both Planmed Clarity Manager and PACS encrypt all data before sending and
decrypted it upon receipt.
The following is an example .pem certificate and key file creation for PACS.
Certificates are created using openssl and keystore tools. Keystore tool is included in the
java package and openssl can be downloaded here:
https://sourceforge.net/projects/gnuwin32/files/openssl/0.9.8h-1/
openssl-0.9.8h-1-setup.exe/download?use_mirror=10gbps-io
1. Create key.pem and certificate.pem for server(PACS) and client(ClarityManager):
openssl req -newkey rsa:2048 -nodes -keyout C:\serverkey.pem -
x509 -days 365 -out C:\servercertificate.pem
openssl req -newkey rsa:2048 -nodes -keyout C:\clientkey.pem -
x509 -days 365 -out C:\clientcertificate.pem
2. Convert clientkey.pem and clientcertificate.pem files to one clientkeystore.p12 file:
openssl pkcs12 -inkey C:\clientkey.pem -in
C:\clientcertificate.pem -export -out C:\clientkeystore.p12
Insert password for clientkeystore.p12 file. This password will be inserted to the
Clarity Manager key file password field.
3. Add server (PACS) certificate.pem to client (ClarityManager) clientkeystore.p12 file:
openssl x509 -outform der -in C:\servercertificate.pem -out
C:\servercertificate.der
C:/"Program Files"/Java/jre1.8.0_151/bin/keytool -import -alias
clientcertificate -keystore C:\clientkeystore.p12 -file
C:\servercertificate.der
4. Add password to serverkey.pem file.
openssl rsa -aes256 -in C:\serverkey.pem -out
C:\serverkeyencrypted.pem
5. Configure SSL connection in PACS.
key file: serverkeyencrypted.pem
cert file: servercertificate.pem
trusted certificates -> specific certificate files: clientcertificate.pem
6. Configure SLL connection to Clarity Manager.
Add the clientkeystore.p12 file to Service/DICOM/Local and Service/DICOM/Remote
Key file fields and insert the password.

Service\DICOM\Local
Secure socket layer (SSL) requires keyfile (JKS format) and password. The key file must
be in pkcs12 format, password protected and contain both Clarity Manager private key
and public keys for all trusted clients.
1. Save the key file to the C:\Planmed\config\cerficates folder.
2. Check the Secure socket layer (SSL) enabled check box.
3. Press the Key file Browse button (button with three dots next to key file field) and
select the key file.
4. Write the key file password in the Password field.
5. Press Save.
6. Restart Clarity Manager.
Service\DICOM\Remote
Secure socket layer (SSL) can be enabled for any AE title. The SSL layer requires keyfile
(JKS format) and password. The key file must be JKS format and password protected.
1. Save the key file to C:\Planmed\config\cerficates folder.
2. Press the Select button and Add (to add new AE title) or Edit (to add SSL layer for
existing AE title) from the Select Storage AE pop-up.
3. Check the Secure socket layer (SSL) enabled check box.
4. Press the Key file Browse button (button with three dots next to key file field) and
select the key file.
5. Write the key file password in the Password field.
6. Press OK to close the DICOM Application Entity (AE) pop-up.
7. Press OK to close the Select Storage AE pop-up.
8. Press Save.
9. Restart Clarity Manager.

Adding / editing application entity settings

1. Click the Select button next to the application entity you want to modify.
2. In the opening window click the AE title you want to modify and then click Add or Edit
button.
3. Enter the necessary information in the opening window and when finished click OK.
Deleting AE titles
1. Click the Select button next to the entity you want to delete.
2. In the confirmation window click Yes.
To close the window without deleting the AE, click No.

DICOM Storage AE configuration

1. To access the configuration dialogue, click the Configure button of the Storage AE.
2. In the opening window the following features can be configured.
Storage
• Auto Storage Destination / Auto Storage Destination for Quality Control
The auto storage destination for patient images and for Quality Control images
can be defined separately.
After selecting Accept study in the Planmed Clarity Manager imaging window the
images will be sent to the location(s) that has been defined here.
• Send FOR PRESENTATION images
The exported Images are enhanced versions of the original images that have
been optimized for viewing and reading. Normally this option should be selected.
• Send FOR PROCESSING images
The exported images are original, unprocessed images also called as raw
images. These images are usually only needed when used with a CAD
(Computer Assisted Detection) software. These images can also be used for
research purposes, for example for testing new image enhancement software.
Normally this option should not be selected.
The software always saves the FOR PROCESSING images, so no separate
setting is needed for this. However, it is possible to define a different Auto delete
interval for FOR PROCESSING images. Before the study has been accepted the
FOR PROCESSING image can be displayed if the image enhancement is turned
off. After the study has been accepted it is not possible to show the FOR
PROCESSING image at the moment.
NOTE
If no selection of format is made, images are sent as standard CT format.
• Use Breast Tomosynthesis format

• Use Enhanced CT format

• IHE Compatibility
IHE is an initiative by healthcare professionals and industry to improve the way
computer systems in healthcare share information.
IHE specification requires that certain DICOM attributes must exist in images,
such as Pixel Padding Value. However, some older DICOM software are not IHE
compatible and IHE compatibility can cause problems for them. If there is a
compatibility issue with an older software de-select this option.
In case of IHE incompatibility the background of an exported image appears
white instead of black.
• Compress tomosynthesis images before sending
If this option is selected, tomosynthesis images are compressed to reduce
storage sending time.
The storage AE may be incompatible with the compressed DICOM format. If this
is the case, images are automatically sent in uncompressed format.
Storage Commitment
• Storage Commitment enabled
By selecting this option the system will request storage commitment from the
storage server.
• Wait for Commitment N-EVENT
By selecting this option the system will wait for commitment response during
same association.
• Storage Commitment Port
Storage Commitment service normally uses the same port as Storage. In this
case leave this field empty. Otherwise type in the Storage Commitment port used
by the receiving system.
Annotation policy
The annotations are the markings that user can add on top of the images, for example
arrows or text. The annotation policy defines how these annotations are handled as
they are normally not exported with the image data.
By selecting No annotations the annotations are ignored when exporting the image.
Network
• Send buffer size / Receive buffer size
Increasing the Send and receive OS network buffer size values will greatly
improve network performance on networks with minimal network activity. Settings
these values to an even multiple of the TCP/IP MSS (Maximum Segment Size) of
1460 bytes (for example 64240) can help increase performance.
• Disable Nagle’s algorithm
The Nagle’s algorithm is a a means of improving the efficiency of TCP/IP
networks by reducing the number of packets that need to be sent over the
network.
To increase the DICOM storage speed the algorithm can be disabled.
DICOM Printer Configuration

In case a DICOM Print license is purchased and installed, images can be printed with
DICOM compatible printers.
DICOM Printer needs to be configured before the DICOM printer can be used. If
necessary please refer to the printer’s DICOM Conformance Statement for more
information.
1. To access the configuration dialogue, click the Configure button of the Printer AE.

2. In the opening window the following features can be configured.
Film box
• Bit depth
The same window center / width values are used for 8 and 12 bit LUTs. In 12 bit
case the output is scaled to 12 bits instead of 8 bits.
• Orientation
Select the appropriate orientation from the Orientation drop-down menu.
• Film size
At minimum the film size should be specified. Select the appropriate size from the
drop-down menu.
The default size is defined by the printer manufacturer.
To configure sizes click the Configure Sizes button.
In the following window select the appropriate film size and uncheck the sizes you are
not using. This way no unnecessary film sizes will be listed.
You can also adjust the width and height by typing the appropriate value in the
Maximum width (mm) and Maximum height (mm) fields.

Check the actual millimeter values of the film sizes from the printer’s manual or
DICOM Conformance Statement.
• Magnification Type
The Default magnification type refers to the Printer’s default value. In this case
the application does not send the Magnification Type value at all. The printer’s
default value should be found in the printer’s DICOM Conformance Statement.
REPLICATE: fast but coarse.
BILINEAR: slower but smoother.
CUBIC: slowest but leads to best available image quality.
NOTE
All printers do not necessarily support all the values of replicate, bilinear and cubic
options. See the printer’s Conformance Statement for details.
• Smoothing type
The smoothing type further specifies the type of the interpolation function. Values
are defined in Conformance Statement. Only valid for Magnification Type CUBIC
• Magnification
The magnification factor 1.0 corresponds to true size printing.
• Header Text Height
Header refers to the text that is printed on top of the film. The header text shows
the institution and the date the image was printed.
The header text in DICOM print will be right aligned on L images. This will be an
optional feature.
The used unit is the same as in font sizes.
• Footer Text Height
The footer text is at the bottom of the film and includes the text Planmed Clarity
Manager.
The footer text in DICOM print will be right aligned on L images. This will be an
optional feature.
The used unit is the same as in font sizes.
• View Label Text Height
View Label is the orientation/projection text, like L-CC, R-CC. This separate
configuration allows for printing orientation/projection text (e.g. L-CC) in larger
size as the other text.
The unit is the same as used in font sizes.

• Annotation Text Height

Annotations refer to the text that user writes on top of the images.The used unit is
the same as in font sizes.
Format
• Print one image per film
This setting is selected by default.
• Print scale bar
Select the Print scale bar option to print the scale bar to images in DICOM
printers.
By selecting this option a cm scale bar will show in both images (left and right)
when printed.
If you do not want the scale bar to be printed uncheck this option.
• Align images by laterality
When printing one image per film the images will be aligned to left or right based
on projection. This is a configurable feature. Example: if the configuration is on,
left (L) images will be aligned to the left side of the film. If the configuration is off,
the images will be centred to the film.
This option is only for the situation where Print one image per film is selected. If
this option is selected: images of left breast are left aligned and images of right
breast are right aligned. If Align images by laterality is not selected, the images
are centred to the film
• Align header and footer text by laterality
Header is the text printed on top of the film. The header text consists of Institution
name and of the date the image is printed.
Footer is the text at the bottom of the film entitled Planmed Clarity Manager.
Header and footer text in DICOM print will be right aligned on left (L) images. This
is a configurable feature. Example: if the configuration is on, in left (L) images
header and footer text is aligned to the right. If this configuration is off, header
and footer text will always be aligned to the left.
This option is only for the situation where Print one image per film is selected and
only for images of left breast. If this option is selected, the header and footer text
for the L images are right aligned like the other image text. If this option is not
selected, the header and footer text for L images are left aligned.
• Crop image to fit to film if needed
If the image size is larger than the selected film, image will be cropped to fit the
film. This is a configurable feature.
If an image is printed to a film that is smaller than the image, the image must be
either scaled down or cropped. If Crop image to fit to film is needed is selected,
the image will be printed in true size but the area that does not fit to the film is
cropped out.
If this option is not selected, the image is scaled down to fit to the film.
Network
• Send buffer size / Receive buffer size
Increasing the Send / Receive buffer size values will greatly improve network
performance on networks with minimal network activity. Setting these values to
an even multiple of the TCP/IP MSS (Maximum Segment Size) of 1460 bytes (for
example 64240) can help increase performance.
• Disable Nagle’s algorithm
The Nagle’s algorithm is a a means of improving the efficiency of TCP/IP
networks by reducing the number of packets that need to be sent over the
network.
To increase the DICOM storage speed the algorithm can be disabled.
Other settings
• Modality Performed Procedure Step (MPPS)

DICOM MPPS SCU service is used together with DICOM Modality Worklist SCU
service. If MPPS service is configured, the ID, status and dates of studies as well as
patient name will be sent to HIS/RIS/MIS when starting the exposure. Dates and
compete list of images including X-ray parameters will be sent to the HIS/RIS/MIS
server after the study has been accepted.
To use MPPS specify the corresponding AE title and check the MPPS option.
• Create new Series for each image
If you are using a general purpose radiological imaging viewer select this setting.
If you are using a dedicated mammography viewer this setting is generally not
required.
• Patient ID’s are unique
Select this setting if the priors are been retrieved from other system into the software.
This setting determines how the patient data is combined.
• Maximum number of storage retries
Sending images to other systems by DICOM Storage can sometimes fail e.g due to
network problem, or the receiving system may be out of resources for a while.
If storage fails, Clarity Manager retries it for a configured number of times. Default is 3
• DICOM logging level (0 = Errors only, 4 = Detailed)
The default setting is 0. The value can be adjusted between 0 and 4 and increased for
troubleshooting purposes.
NOTE
Make sure to set the value back to 0 when finished with troubleshooting.

2.1.9 Imaging / Display and Print

In the Display and Print tab you may select what information is shown in the imaging
window or printout.
Patient info
To select whether the patient ID or date of birth will be shown in the patient list and images
and whether to use the short date of birth format check the appropriate box.
Patient name order

To select whether to display the patient’s first or last name as first on the list check the
appropriate option.
Optional list columns

Select the worklist columns which you want to be displayed in the user interface. The
columns include: Age, Gender, Referring Physician, Operator, Protocol, Scheduled
Station, Accession number, Modality and Study description.
The optional list columns refer to both Modality Worklist and Local Study Archive. The
columns Protocol and Scheduled Station are only in Modality Worklist and the column
Operator is only in Local Study Archive.
The columns that are left unchecked do not appear in the lists. You need to click Save and
restart Clarity Manager before the setting is applied.

Fonts
In the Fonts field the font size can be defined for:
• Annotations
• View label
• Export (Burn in)
Type the appropriate font size in the corresponding field.
The minimum font size is 12 and the maximum 24. The maximum export font size is 99.
Image view
By selecting the Show scale bar option the scale bar will be shown next to the exposures
taken.
Show image parameters

Select the parameters displayed in the interface by checking the box next to the
parameter. To unselect a parameter uncheck the box.
Print image parameters

Select the parameters displayed in the interface by checking the box next to the
parameter. To unselect a parameter uncheck the box.
To save the settings click the Save button.
To restore the previous settings click the Restore button.
2.1.10 Clarity Guide

For a description of the settings in the Clarity Guide / Motor tests, Handbox tests, Needle
properties and X Corrections tabs, refer to the Chapter G: "PLANMED CLARITYGUIDE"
on page 197.

2.1.11 Infra / Database

In the Infra / Database tab you can set auto delete time and define auto delete conditions,
set the number of day the images are stored, permanently delete rejected images, clear
history records and storage queue, run auto delete, set the patient and study list to be
fetched at startup, set auto generation for patient ID’s, and set the history records to be
kept.
To change these settings click the corresponding button or enter the appropriate value to a
corresponding field.
To save your settings click Save. To restore previous defaults click Restore.
Auto delete
For automatic removal of images check Auto delete enabled option.
To set the auto delete time enter the appropriate time to the Run at (HHMM, 24h clock)
field.
Auto delete conditions

The auto delete conditions are configured at start up and after this once a day.
• Storage commitment is required
By selecting this option the system will request storage commitment from the storage
server.
• Media storage qualifies for auto delete
By selecting this option the images are automatically deleted if they have been stored
on a CD/DVD, USB memory or other external media even if not sent to PACS.
• Delete patient information after all images are deleted
Check this option for automatic removal of patient information once there is no more
images stored for that specific patient.

Number of days to keep

To set the number of days the different types of images are kept enter the number of days
to the corresponding field.
• Acquired FOR PRESENTATION images
The exported Images are enhanced versions of the original images that have been
optimized for viewing and reading. Normally this option should be selected.
• FOR PROCESSING images
The exported images are original, unprocessed images also called as raw images.
These images are usually only needed when used with a CAD (Computer Assisted
Detection) software. These images can also be used for research purposes, for
example for testing new image enhancement software. Normally this option should
not be selected.
The software always saves the FOR PROCESSING images, so no separate setting is
needed for this. However, it is possible to define a different Auto delete interval for
FOR PROCESSING images. Before the study has been accepted the FOR
PROCESSING image can be displayed if the image enhancement is turned off. After
the study has been accepted it is not possible to show the FOR PROCESSING image
at the moment.
NOTE
At least one of these options must be selected, otherwise no images are sent.
• Rejected images
You can set the storage time for images that no longer show in the study list but are
still saved in the database by entering the number of days in the corresponding field.
• Imported images
You can set the time period after which the imported images are automatically deleted
from the database by entering the desired number of days in the corresponding field.
• Quality Contol images
The quality control images are taken during Quality control tests. For more
information see Planmed Clarity Quality Control Manual (publication number
20009709).
Actions
• Delete rejected images
Click this button to delete the rejected images from the database.
• Clear history records
History records show what information was modified or deleted from the database
and by whom.
• Clear storage queue
This function can be used for example if the storage destination is unavailable due to
technical problems.
If you clear the storage queue, the unsent studies should later be manually resent. To
resend the studies go to Local Study Archive select the studies to be sent and select
Send.
To clear the storage queue click the Clear Queue button.
• Run auto delete
By clicking this button the studies can be deleted. The number of deleted images and
studies is shown after the button is pressed.

Other settings
• Fetch patient list at start-up
By selecting this option the list of all patients stored in the database will be fetched
and shown when starting the software.
• Fetch study list at start-up
By selecting this option the list of all studies stored in the database will be fetched and
shown when starting the software.
• Auto-generate patient ID’s
By selecting this option an ID for each patient will be automatically generated if no ID
is entered in local patient registry.
• Keep history records (not recommended)
History records mean information about who and when modified or deleted data from
the database. Keeping the history records in the database can gradually slow down
the performance of the system.
• Compress tomosynthesis images in database
Tomosynthesis images are compressed in the local database to save disk space.
• Check compressed tomo pixel data integrity
Compressed tomosynthesis pixel data is checked when the image is sent to storage
and when the study is opened.
This check verifies that the original pixel data has not changed.
2.1.12 Infra / Transfer

The settings can be copied and returned from one workstation to another for example in
case a computer collapses.
• Save settings to file
Click the button to save Clarity Manager settings to a file. Browse the folder, enter a
filename for the settings file and click the Save button.
By default the file is save to C:\Planmed\settings folder with CM_Settings.cfg
filename.
The settings will also be saved to the ZIP file created by Collect logs function in the
Support menu.
• Load settings from file
Click the button to load Clarity Manager settings from a file. Browse the file and click
Open button to load the settings.

2.1.13 Infra / Security

The Login settings affect the information requested when logging into Planmed Clarity
Manager.
Login Username and Password

In the Login Username and Password field you can define username and password
requirements at login by checking the appropriate check box from the following options:
• username and password are required
• username required, password is optional
• neither username nor password is required.
Password
In the Password field you can set the minimum number of characters required for
password by typing the appropriate number in the corresponding field.
NOTE
The recommended minimum number of characters is 5.
NOTE
In case you change the login setting from Username not required from then on you cannot
use the software without knowing username or/and password.
Automatic login
If you are registered in the database as a Windows user, logging in is not required and the
main window of the Clarity Manager opens automatically.
The username of the current user is shown on the top right corner of the window after
login.
For more information on logging in, see the user’s manual (publication number 20009437).

2.1.14 Infra / Groups

In the Groups tab you can add new user groups and update or delete existing user groups.
Adding new user group
NOTE
All permissions are granted at group level. Every user must belong to at least one user
group.
1. Click the Add button.

2. In the following window enter the description of the group in the Description field and
name the group by entering the name in the Group Name field.
3. Set the group permissions. The options are:

• All permissions
• Access Service Mode
• Perform Quality Control
• Perform Calibrations
• Manage users
• Acquire images
• Delete studies
4. When finished click OK.
To exit the settings without saving the settings click Cancel.

Updating existing user groups

1. Select the user group to be updated from the list.
2. Click the Update button.
3. Set the group permissions. The options are:
• All permissions
• Access Service Mode
• Perform Quality Control
• Perform Calibrations
• Manage users
• Acquire images
• Delete studies
To exit the settings without saving the settings click Cancel.
Deleting existing user group

1. Select the user group to be deleted from the list.
2. Click the Delete button.
NOTE
Built-in user groups cannot be deleted.
3. Confirm the action, click OK button.
2.1.15 Infra / Users

In the Users tab you can add, update or delete individual users from the database.
Adding new user

1. Click the Add button.

2. In the Add User window’s User field, enter the necessary user information by typing or
selecting options from the drop-down menu.
NOTE
The Username field is obligatory. The default user can be used if necessary.
NOTE
Only one default user should be defined.
NOTE
Only users with administrator rights can set the user interface language.
For more information on setting language for existing user profiles, see the user’s
manual (publication number 20009437).
3. In the Add User window’s Member of Groups field, select at least one of the created
groups.
4. When finished, click OK.
To exit the screen without saving your modifications click Cancel.
Updating existing user

1. Select the user to be updated from the list.
2. Click the Update button.

3. In the following window update the necessary user information.
The default user can be used if using a username is not obligatory.
NOTE
Only one default user should be defined.
4. In the Member of Groups field select at least one of the groups.

To exit the screen without saving the modifications click Cancel.
2.2 SUPPORT menu

The Planmed Clarity Manager Support menu includes information on logs, licenses and
manuals.

Pressing the Collect logs button in the Support menu opens the Collect Logs pop-up
where it is possible to configure a desired time period from which to collect logs.
For more information on the Support menu, see the user’s manual (publication number
20009437).

3 PLANMED CLARITY FPD EMULATOR Chapter F: PLANMED CLARITY MANAGER
3 PLANMED CLARITY FPD EMULATOR

Bundled with Planmed Clarity Manager is software that can be used to emulate image
acquisition with Planmed Clarity flat panel detector (FPD).
The emulator can be used for:
• demonstrating image acquisition
• fine-tuning image windowing / enhancement parameters
3.1 Using FPD emulator

1. Add images suitable for emulation to the folder C:\Planmed\demo_images.
Naming convention for screening image files is:
<Laterality>-<Projection>.tif (for example L-CC.tif).
Stereo procedure images are named as ST1.tif ST2.tif and Scout.tif.
It is best to use TIFF images saved by Clarity Manager during image acquisition. The
uncalibrated files are saved to folder C:\Planmed\temp_images if setting Save raw
images has been selected in Settings / Device.
2. Acquire screening or stereo procedure images (St1, St2, Scout) with Planmed Clarity.
3. Copy the files from C:\Planmed\temp_images to C:\Planmed\demo_images.
4. Rename the files using naming convention as described above.
5. To change the IP address on the SERVICE & CONFIGURATION view, select the
Imaging / Device tab and click the Demo button.
6. To save the settings click the Save button at the bottom of the screen.
7. Open the emulator by clicking
C:\Planmed\ClarityManager\StartClarityEmu.bat
8. Restart Planmed Clarity Manager and start a new study.
9. When the system is ready for acquisition, click the required view button in Planmed
Clarity Emulator window.
NOTE
Remember to change the settings back to original values before starting to acquire patient
images.

Chapter F: PLANMED CLARITY MANAGER 4 TROUBLESHOOTING
4 TROUBLESHOOTING
If an error situation occurs, first try the following corrective actions (if not otherwise
instructed):
1. Store and close all patient studies.
2. Close all software applications that are running.
3. Check that all cables are connected.
4. Restart the Acquisition workstation and the software applications.
5. If this does not help, shut down the Planmed FFDM/DBT mammography X-ray unit
and the AWS workstation.
6. Switch on the X-ray unit, and turn on the AWS workstation.
If the problem persists, contact your local technical support.

5 LIST OF ABBREVIATIONS Chapter F: PLANMED CLARITY MANAGER
5 LIST OF ABBREVIATIONS
Table 4: List of abbreviations
Abbreviation Definition
AWS Acquisition Workstation
CD/DVD Compact Disc / Digital Video Disc
DBT Digital Breast Tomosynthesis
DICOM Digital Imaging and Communications in Medicine

FFDM Full Field Digital Mammography
FPD Flat panel detector
GSPS Gray scale Soft copy Presentation State
HIS/RIS/MIS Hospital Information System / Radiology Information System /

Mammography Information System
HV High Voltage
kV Kilovolt
LUT Look Up Table
mAs Milliampere second
MG Mammography
mm Millimeter
MPPS Modality Performed Procedure Step
QC Quality Control
SCU Service Class User
TIFF Tagged Image File Format

Planmed ClarityGuide is a digital biopsy imaging system compatible with Planmed Clarity
FFDM X-ray unit.
The Planmed ClarityGuide system consists of the Planmed Clarity FFDM X-ray unit that is
equipped with the needle guide unit and the Acquisition Workstation (AWS), including a
personal computer with the Planmed Clarity Manager software, which is used for acquiring
mammography images, determining the lesion coordinates, and taking the biopsy.
To ensure the accuracy of the Planmed ClarityGuide system, the required calibrating and
testing procedures are described in this chapter.
NOTE
Planmed ClarityGuide system service, including the calibrating and testing procedures
must be done by qualified personnel only.
Technical manual Planmed ClarityGuide 197

1 TESTING AND CONFIGURING
1.1 Testing hand-held control box

2. Prepare the X-ray unit for stereotactic biopsy, by attaching:
• stereo biopsy platform
• needle guide unit
• stereo biopsy paddle
• compression adapter
as described in section SYSTEM SETUP FOR STEREOTACTIC BIOPSY in the
Planmed Clarity Guide user’s manual.
3. Adjust the stereo biopsy paddle to the lowest position (at 0).
4. Attach the hand-held control box (part number 07004080).
The hand-held control box is connected to the Control box connector behind the X-ray
unit.

6. In the Home screen, click the main selection button, click Service icon and select
Clarity Guide and Handbox tests tabs.
7. Click Start Test button to initiate the handbox test sequence and follow the
instructions on the screen, by pressing the desired control box buttons and safety
switch.
8. Click Continue button when instructed - the test is completed.
If some test fails, check the hand-held control box connection. If problem persists,
contact your Planmed representative.
198 Planmed ClarityGuide Technical manual

1.2 Testing motor

Clarity Guide and Motor tests tabs.
6. Click Start Test button to initiate the motor test and reference point sequence and
follow the instructions on the screen, that is, click Continue button when each phase
of the reference run is completed.
7. When the test is ready, click the Clear button.

1.3 Setting needle properties
NOTE
Also see 4 "DETERMINING NEEDLE LENGTH AND SAFETY DISTANCE" on page 216
and 4.2 "Determining safety distance" on page 219.

Clarity Guide and Needle properties tabs.
5. Select a needle from the Needle Name field and click Edit button.
6. Modify the settings of the selected needle, and click Update button.
7. Exit the Clarity Manager to update changes.

1.4 Configuring X correction

The X correction parameter of the needle guide is adjustable. This allows user to
compensate if needle guide is not in line with the movements in X direction.
NOTE
Usually there is no need for changing this setting at all.

Clarity Guide and X Correction tabs.
4. In the appearing window set new value to the X Correction field and click Save button.

2 CALIBRATING NEEDLE GUIDANCE UNIT Chapter G: PLANMED CLARITYGUIDE
2 CALIBRATING NEEDLE GUIDANCE UNIT
2.1 Preparing X-ray unit for stereotactic biopsy

unit.
2.2 Positioning X-ray unit

1. Select CC view.
2. Touch the St1 button on the X-ray unit touch screen.
3. Drive the X-ray unit to the St1 position using the middle foot pedal.
Clarity_foot_control3.eps

Chapter G: PLANMED CLARITYGUIDE 2 CALIBRATING NEEDLE GUIDANCE UNIT
2.3 Initiating calibration from Planmed Clarity Manager

2. In the main window, select Local Patient Registry tab.
3. Click Start Study button.
4. In the Start Study window, tick option Quality Control Phantom at the bottom of the
window, then click OK button.
5. In the next window, click the Calibration button (under the ClarityGuide title).
6. Click Calibrate button to begin and follow the instructions on the screen.
7. Wait until the needle guidance unit stops.
8. Open and close the safety switch as instructed on the screen.
safety_switch.eps
en
op
clo
e n s ed
op
9. Insert the guide bushes for the test needle into the upper and lower needle guides.
10. Place 90 mm test needle in needle holder.
11. With the hand-held control box, drive the needle guidance unit to the following
location: X=0.0, Y=37.0 and Z=needle tip 0.1 mm from platform.

Drive carefully the Z-direction down until the needle tip is close to the platform. With
the feeler gauge (0.05 mm, delivered with the calibration toolkit, part number
07004090) check and verify the distance between the needle tip and platform.
NOTE
The space between the platform and the needle tip should be 0.05 - 0.1 mm. Test the
space use the feeler gauge delivered with the needle guidance unit.
12. Continue to St1 and St2 image acquisition by clicking More images... button at the
Clarity Manager.
13. Continue from the next section 2.4 “Taking exposures” on page 204.
2.4 Taking exposures

1. Protect yourself from radiation.
2. Take St1 exposure and wait for the image to appear on the screen.
After the image has been taken, the data will be transferred to the computer and St1
image appears at the bottom left of the monitor.

image appears at the bottom right of the monitor.
7. Click Calibration button.
The program returns to the Calibration screen.
8. Follow the instructions on the screen:
a. Mark points 1 and 2 on the upper image.

b. Mark points 3 and 4 on the lower image, as shown in the figure below.
9. The program calculates new correction parameters. Click Save button.
NOTE
This takes few seconds.
• If the correction parameters are within the allowed range, the system saves them.
• If the correction parameters are not within the allowed range, the system rejects
them. Start the calibration procedure from the beginning.
NOTE
Verify that the parameters were updated. In case the parameters were not in
acceptable range the needle guide must be mechanically realigned so that the
software correction parameters settle within their range:
X-correction +150 to +350

Y-correction +250 to +400
Z-correction +1800 to +2200
X1, X2, Y1, Y2 from -1000 to + 1000
10. Click Done.

The calibrating procedure is complete.

11. When the calibration is completed successfully, remove the needle from the needle
holder and close the safety switch (turn lever to the middle).
safety_switch.eps
en
op
clo
en se d
op
12. Wait until the needle guide stops.

13. Verify the needle accuracy as instructed in section 2.5 "Verifying calibration results
and adjusting Z-correction parameter" on page 207.

2.5 Verifying calibration results and adjusting Z-correction parameter
NOTE
After you have calibrated the needle, the calibration results must be tested on a phantom
as instructed below.
2.5.1 Preparing X-ray unit

1. Place the calibration phantom to the stereo biopsy paddle opening.

2.5.2 Taking exposures

1. Select CC view.


image appears at the bottom right of the monitor.

2.5.3 Verifying positioning accuracy

1. Click the Targeting procedure button in the Clarity Manager.
2. Wait until the needle guidance unit stops. To continue, open and close the safety
switch of the needle guidance unit when instructed.
safety_switch.eps
en
op
clo
e n s ed
op

2.5.4 Marking targets on images

1. Mark targets 1 and 2 to both images.
a. Mark target1 by clicking the desired target point on the upper image. A cross will
mark the point, and horizontal lines will extend across the upper and lower
images. After your selection Mark target 1 is ticked and you are able to mark
target 2.
b. Mark target 2 by clicking the desired target point on the lower image. You must
click between the green horizontal lines. After your selection Mark target 2 is
ticked.
See example below.
2. The Needle Selection window appears, select the 90 mm needle for calibration.
Confirm your selection by clicking Select button.
The selected needle and the maximum compression thickness are displayed in the
needle guide workflow panel at Clarity Manager.
The compression thickness shown on the touch panel must be less than the
maximum compression thickness indicated by the system.
3. Check that the stereo biopsy paddle is below the maximum compression value.
4. Start the needle guide motors by clicking Drive needle guide button.
When the needle guide has reached the target, it will be shown in the needle guide
workflow panel (Target Reached). The selected needle, needle length and safety
distance are displayed.
5. Wait until the needle guidance unit stops and open the safety switch (turn lever to the
side).

6. Insert a 90 mm test needle into the needle holder.

7. Verify that the needle is correctly positioned in X and Y-directions.
The distance between the needle tip and the target must be less than 0.5 mm in X and
Y directions.
If not, repeat calibration procedure in section 2 "CALIBRATING NEEDLE GUIDANCE
UNIT" on page 202.
8. Check the Z-direction.
The distance between the needle tip and the phantom surface (Z-direction) should be
0.8 mm or less.
If necessary, drive the needle guidance unit up/down with the hand-held control box
and note down the distance driven (Z-value).
NOTE
To check the needle height use the feeler gauge delivered with the needle guidance
unit.
9. If the distance between the needle tip and the target is greater than 0.8 mm in Z-
direction, click Return to imaging... button, and follow the instructions in the section
2.5.5 "Adjusting Z-correction parameter" on page 212.

2.5.5 Adjusting Z-correction parameter

1. Modify the Z Correction parameter by adding the deviation (reading on the handbox
display, in the previous section, multiplied by 10) to the Z Correction field.
E.g. if the Z-value in the hand-held control box is -2.7, and the existing value in the Z
Correction field is +2105, the new value to be set should be:
+2105 + (-2.7 x 10) = +2078
2. Click Save. The Parameters saved indication appears, click Done button.
Follow the instructions for resetting the needle guide unit.
3. Click More images... button.
4. Click Targeting Procedure button.
5. Verify the needle tip positioning accuracy at each corner of the calibration phantom by
repeating the steps in section 2.5.4 "Marking targets on images" on page 210.
A1 A9
G1 G9
6. Click Next Target to reset needle guide and open and close the safety switch as
instructed.
7. Click Return to imaging button.
8. Adjust the stereo biopsy paddle to the height of 8 cm from the platform.

15. Take St2 exposure by pressing the exposure button.

16. Repeat the procedure starting from section 2.5.4 "Marking targets on images" on
page 210, but this time modify the Z-correction parameter by adding only half of the
deviation to the Z-correction field.
17. To verify the positioning accuracy repeat the targeting and positioning procedures at
the lowest and highest positions.
NOTE
The limit values for the hand-held control box are ± 0.5 mm in X and Y direction and ±
0.8 mm in Z direction.

18. In case the required accuracy is not met repeat the calibration procedure from the
beginning paying particular attention to the marking of points 1 - 4 and the needle tip
locations. Even the slightest error in position marking may affect to the accuracy.
19. Finally, when the calibration and verification are successfully completed, click the
Accept button in the study to save and close the results.
2.5.6 Resetting X-ray unit from stereotactic biopsy

1. On the X-ray unit touch screen select End procedure. and accept it with Yes.
2. Open and close the safety switch of the needle guide unit. The needle guide is reset.
3. Touch the Scout button and drive the the X-ray unit to the position using the middle
foot pedal.
4. Touch the Remove DigiGuide button.
5. Remove the needle guide bushes, the stereo biopsy paddle and the phantom, and
finally the needle guide unit.

Chapter G: PLANMED CLARITYGUIDE 3 CALIBRATING MOTORIZED COMPRESSION
3 CALIBRATING MOTORIZED COMPRESSION

• compression bars
4. Raise the stereo biopsy paddle of the needle guidance unit until it reaches the
compression adapter magnets.
Magnets
Stereo biopsy
paddle
5. Select Calibration vertical tab and Paddle Offsets horizontal tab.
6. Place the compression calibration gauge (part number 20002069) to the front and
symmetrically middle of the stereo biopsy platform (as shown in the X-ray unit’s
diplay).
Once the calibration is ready, Calibrated on a green background is shown in the X-ray
unit’s diplay.

4 DETERMINING NEEDLE LENGTH AND SAFETY DISTANCE Chapter G: PLANMED CLARITYGUIDE
4 DETERMINING NEEDLE LENGTH AND SAFETY

DISTANCE
4.1 Determining needle length
NOTE
Determining the needle length must be done in co-operation with Planmed’s authorized
trainer and a radiologist. Never attempt to do this without adequate training.
NOTE
In addition to the needle length, a safety distance for each biopsy needle must be
determined and programmed. Refer to section 4.2 "Determining safety distance" on page
219.
NOTE
Make sure to use the right needle holder, either low or normal sized.
CAUTION
Planmed recommends to protect this procedure by password to avoid unintentional
changing of the needle length.
CAUTION
When programming the needle guide for biopsy needles, choose either low
(optional) or high needle holder. If you use the lateral arm, make sure the correct
needle length and the correct needle holder have been programmed and chosen.
Never use the lateral arm without adequate training.
CAUTION
When programming the low needle holder, 28 mm (2,8 cm) must be added to the
needle length. The length is indicated in millimetres
The needle length indicated on the package can only be regarded as a rough guide. The
actual length of a needle applicable to the needle guidance unit depends on how deep the
needle housing is located in the guide bush.
The length of each needle should be determined accurately (within 0.1 mm) as described
below for different stroke distances, and stored into the ClarityGuide memory as instructed
in section 1.3 "Setting needle properties" on page 200.
NOTE
When measuring the needle length for a biopsy gun only the mandrel is inserted into the
unlocked biopsy gun.


Chapter G: PLANMED CLARITYGUIDE 4 DETERMINING NEEDLE LENGTH AND SAFETY DISTANCE
4. Insert the test phantom into the rectangular window of the stereo biopsy paddle.

unit.
6. Set the needle holder to a height of 60 mm using the hand-held control box (z display:
60.0).
7. Open the safety switch (turn lever to the side) to release the path for the needle.
safety_switch.eps
en
op
en
op
clo
se
d
8. Insert the guide bushes for the test needle into the upper and lower needle guides.
9. Slide the 90 mm test needle in with the long side down into the guide bushes as far as
possible.
10. Slide the stereo biopsy paddle up carefully until the phantom surface just touches the
tip of the needle.
11. Lock the stereo biopsy paddle with the paddle locks.

12. Remove the test needle and the guide bushes.

13. Insert the guide bushes for the biopsy needle.
14. Carefully slide the biopsy needle in (the relaxed state when using a needle gun) so far
that the needle base touches the upper guide bush, and estimate the deviation of
needle tip from the phantom surface.
• If there is no deviation, continue from step 18.
15. Remove the biopsy needle and close the safety switch (lever switch in middle
position).
16. Using the hand-held control box, move the needle holder in the Z direction by the
estimated deviation (the lower switch up or down).
17. Open the safety switch (turn lever to the side), continue from step 14, and repeat step
14 – step 17 until the needle tip is in the correct position.
18. Read the Z value from the hand-held control box and write it down.
19. Calculate the needle length in mm (L). The needle length (L) is the distance between
the end of the housing and the centre of the needle/sample notch.
Needle tip to middle of sample notch length (K)
Needle length (L)

Biopsy_Gun_Needle_Length.eps
Needle base/housing Needle tip
Middle of
needle/sample
notch
a. Measure the distance between the needle tip and the centre of the notch K.
b. Calculate the needle lenght setting value with the following formula:
L = 150.0 - Z - K
NOTE
If an automatic biopsy gun is NOT used: The elasticity of the finding causes it to recede
from the needle tip and this is why the needle has to be inserted deeper than what is
calculated by the needle guidance unit. The needle length value entered into the needle
guidance unit computer must therefore be at least 5 mm less than the actual needle length.
Depending on the specific nature of the breast tissue, the examiner has to further correct
the position of the needle using the hand-held control box.
NOTE
If an automatic biopsy gun IS used, there is no need to program a shorter needle length
because, owing to the high penetration speed, the finding will not be displaced.
WARNING
Owing to the distance between needle tip and centre of the notch (between 11 mm
and 18 mm) the needle tip may be significantly below the lesion, depending on the
needle type.

Chapter G: PLANMED CLARITYGUIDE 4 DETERMINING NEEDLE LENGTH AND SAFETY DISTANCE
20. Store the needle length (L) into the memory of the operator’s console (see section 1.3
"Setting needle properties" on page 200).
21. Repeat this procedure for all biopsy needles that will be used in the biopsy
examinations.
22. Having determined and stored the needle length for all needles to be used in the
biopsy examinations, each needle must be tested by driving it to the lowest position
with the hand box. The needle must not hit the lower stereo biopsy paddle. If the
needle hits the lower stereo biopsy paddle it must be re-programmed, re-tested and
stored again in the memory.
NOTE
If the needle does not hit the wanted target adjust the needle length again.
4.2 Determining safety distance
NOTE
This should always be done under the supervision of a radiologist.
In addition to the needle length, it may be necessary to determine and program a safety
distance for each biopsy needle. The safety distance is required when biopsy guns and
vacuum-assisted biopsy devices are used.
In order to program the safety distance consult the needle supplier. It is usually
determined according to the length of the stroke in the biopsy gun (for example, 22 mm or
15 mm with Bard Magnum Biopsy Gun) by adding between 1 mm - 5 mm to the stroke
length depending on the location of the target. The needles must be programmed
separately for each stroke length.
NOTE
When using localization wires in vertical (CC) projection the safety distance must be
programmed.


Chapter H: DIAGRAMS
Compression Paddle Recognition

ID - MAGNETS :
Code 20002418 NAME:
NUMBER: A B C D E
J1
1 +VAA 1 Large 24 x 30 Paddle - - - - X
Compression Mechanism 2
3
4
FMS
PWF
GND
2
3
Small 19 x 23 Shifting Paddle
Spot 9 x 6 Paddle
-
-
-
-
-
-
X
X
-
X
5 +VAA
6 FEX
4 Spot 10 x 10 Paddle - - X - -
7 XUL 5 Short and Deep Paddle - - X - X
8 MLFB
9 MLFF
6 Perforated Biopsy Paddle - - X X -
+15
PUL
10 MUFB ... ...
11 MUFF
GND 12 GND
11 Stereo Biopsy Compression Adapter with Bars - X - X X
MXXA1
... ...
MXXB1
13 MXB2
MXA2
MXB2
MUFF
MUFB
+VAA
MLFB
MLFF
GND
XUL
14
FEX
MXXB1
15 MXA2
20 Tomosynthesis 24 x 33 Paddle X - X - -
16 MXXA1 1 2 3 4 5 6 7 8 9 10 11 12 ... ...
COMPRESSION UP LIMIT 17 SCA
GRN
WHT
25 Mag. Spot 9 x 6 Paddle X X - - X
GRN
PINK
WHT
PINK
BRN
GRY
BRN
GRY
YEL
YEL
18 +5V
19
20
SCL
2/D 8/B 26 Mag. Spot 10 x 10 Paddle X X - X -
GND
1/E 4/C 16/A
MAXVIEW UPPER MODULE

Code 20002684 TO TUBEHEAD B D
INTERFACE PCB
MUFB
MUFF
CONNECTOR P2
MLFB
MLFF
GND
A
FEX
C E
MUFF
MUFB
MLFB
MLFF
GND
FEX
TO TUBEHEAD
GRN
YEL /GRN
WHT
PINK
GRN
WHT
PINK
YEL /GRN
BRN
GRY
BRN
GRY
YEL
YEL
1 2 3 4 5 6 7 8 9 10 11 1213 14
3 YEL/GRN
2 BLK
1 RED
+15
PLL
GND 1 2 3 4 5 6
MUFB
MUFF
MLFB
MLFF
GND
FEX
COMPRESSION LOW LIMIT MAXVIEW KEYBOARD P3 1 2 3 4 5 6 1 2 3 4 5 6
ADAPTER PCB
GRN
WHT
PINK
MUFB
BRN
MUFF
GRY
MLFB
MLFF
YEL
GND
FEX
MXD2
MXD1
MUFB
MXC2
MXC1
MUFF
+VAA
MLFB
MLFF
GND
XUL
FEX
P2 1 2 3 4 5 6 7 8 9 10 11 1213 14
WHT
MUFB 1
P1 MLFB 2
BRN
Code 20002676
Code 20007240
WHT +VAA GRN
3
GRN
WHT
WHT
3
PINK
FEX
GRN
MXD2
MXD1
BRN
BRN
1
GRY
RED
MXC2
MXC1
BLU
MUFB
Code 7827813
YEL
YEL
GRN XUL YEL
2 MLFF 4
2 MLFF J1 BRN GRY
1 GND MUFF 5
3 MLFB
PINK
4 XUL GND 6
5 FEX
BLU
Code 20000487
Code 20002675
6 GND
1 2 3 4
+VAA
RED
7 GND +VCC
GRN
8 PWF J3 DISP
9 FMS
J5 BRN
GND 1
+VAA
10 +VAA GRN
GND
XUL
PUL 2
11 GND WHT
+15V 3
12 SCL
13 +5V J4
14 SCA GND 1
BRN
MUFB
MUFF
+VAA
MLFB
MLFF
GND
15 MXXA1 GRN
FEX
XLL
PLL 2
16 MXA2
3
WHT
+15V
17 MXXB1 P4 8 7 6 5 4 3 2 1
18 MXB2 Code 20000488
PINK
WHT
GRN
BRN
GRY
RED
BLU
YEL
19 GND
20
MXXA1
MXXB1
MUFF
MXA2
+VAA
MXB2
MUFB
MUFF
+VAA
+VAA
MLFB
MLFF
GND
PWF
GND
GND
PUL
FMS
XUL
PLL
FEX
J2
RED 1 2 3 4 5 6 7 8 9 10 11 12 13 141516 17 181920
Code 20009148
1 GND
BLU
2 SCL
WHT/PINK
SHELF CPU INTERFACE PCB P1

WHT/GRN
WHT/GRY
PINK/BRN
GRY/PINK
BRN/GRN
GRY/BRN
WHT/YEL
YEK/BRN
RED/BLU
GRN 3 SCA
YEL 4
WHT
PINK
GRN
BRN
GRY
RED
BLU
+5V
BLK
YEL
VIO
J5 SHELF CPU INTERFACE PCB P2

Signals
Code 20002674 SHELF CPU INTERFACE PCB P9 SHELF CPU INTERFACE PCB P8
COMPRESSION MOTOR
+VCC +33VDC Supply Voltage Code 20009595 PIM PCB J16
+VAA +15VDC Supply Voltage Code 20009453 ETHERNET SWITCH PCB J5
3 RED WHT 1 WHT
3 MPB1 1
BLU YEL BRN
5
+VDC +370VDC 5 MPB2
7 YEL BLU
2 2
GRN
PIM PCB J22
7 MPA1 3 3
9 MPA2 9 WHT RED 4 4 YEL
-VDC -370VDC
Code 20009450
GND System Ground
ROTATION BOTTOM LIMIT
Code 20009345
Code 20009147
A(CDLL) Compression Encoder A-channel

B(CDLR) Compression Encoder B-channel
CANH CAN-Bus High Wire STOP
Code 7827742
Code 20009671 Code 20002663 SW.
CANL CAN-Bus Low Wire
Code 20007243
CLKL Clock Signal to Left Display
L.GRN
PURP
GRN
WHT
PINK
ORG
WHT
BRN
RED
GRY
YEL
BLU
BLK
WHT
GRN
BRN
PINK
GRN
GRN
BRN
BLU
YEL
GRY
YEL
GRN
RED
BLU
RED
BLU
1
2
CLKR Clock Signat to Right Display J1 1 2 3 4 5 6 J2 1 2 3 4 5 6 J3 1 2 3 4 5 6 7 8 J4 1 2 3 4 J5 1 2 3 4 5 6 7 8 9 10 11 12

J20 1 2 3 4 5 6
DIRL Lift Motor Direction Control Signal
MPA1
MPA2
CANH
MPB1
MPB2
+VAA
+VAA
GND
MSCL
+VCC
+VCC
+VCC
SYNC
CANL
CDLR
STOP
STOP
CDLL
GND
GND
GND
GND
DISP
GND
PWF
FMS
PEN
PUL
EXP
PRL
PLL
J7 +VAS
DIRR Rotation Motor Direction Control Signal REL LEFT 1 WHT ROB
BRN
2
DISP Needle Unit Power On/Off REAR INTERFACE PCB PRE LEFT
3
GRN GND
REL RIGHT YEL
PRE RIGHT 4
GRY
ELMP Exposure Lamp WHT
J11 DISP 5
RED
YEL
3 +VAS PNK
GRN PHCL 6
2 LIU BLU
EXP Exposure Signal BRN 1 GND
DIRL 7
8
RED 1 2
PLSL
J12 9
BLK 1 2
FEX MaxView Foil Exchange Button WHT
3 +VAS KEYL
10
VIO
RED
YEL
GRN ROU TX
2 GRY/PNK
RX 11
FMS Force Measurement Signal BRN 1 GND
DGND 12
BLU/RED
WHT
J13
LID Lift Down Limit GRN
3
2
+VAS
LID
J6
WHT/GRN
BRN ELMP 1
1 GND
LIR Lift Reference Signal J14 SRL 2
BRN/GRN
WHT/YEL
WHT +VAS STOP 3
3 YEL/BRN
LIU Lift Upper Limit GRN
2 ROB 4
WHT/GRY
BRN EXP 5
1 GND GRY/BRN
MLFB MaxView Lower Module Backward Button WHT
J15 SCNT
GND
6
7
WHT/PNK
3 +VAS PNK/BRN
GRN 8
MLFF MaxView Lower Module Forward Button BRN
2 LIR CLKL
1 GND J8 BLK
MUFB MaxView Upper Module Backward Button WHT
J16 SYNC 1
BRN
3 +VBS 2
GRN PLSR RED
2 ROR 3
MUFF MaxView Upper Module Forward Button BRN 1 GND
STOP YEL
Code 7827804
+VCC 4
GRN
PHCR 5
MPA1 Stepper Motor Phase A1 J19 SCNT 6
BLU
WHT
1 GND 7
PURP
MPA2 Stepper Motor Phase A2 1 +VCC DIRR 8
2 2 J9
MPB1 Stepper Motor Phase B1 3 GND STOP 1 RED
2 YEL
GND
MPB2 Stepper Motor Phase B2
PRE RIGHT
REL RIGHT
PRE LEFT
MSCL Serial Communication Line (Mammo)

REL LEFT
MPB17
RTCLK
MPA1
MPA2
+VCC
+VCC
MPB2
+VAA
MSCL
+VCC
+VCC
SCNT
+VAA
CDLL
CDLR
PHCL
ELMP
PHCR
STOP
SYNC
CLKR
KEYR
KEYL
CLKL
TEST
PLSL
GND
PLSR
GND
GND
GND
ROU
DIRR
PWF
DISP
ROB
ROR
DIRL
FMS
PRB
PEN
PRU
+5V
EXP
SRL
PRR
CAI
LIU
LIB
LIR
PEN Power Enable

c1
c2
c3
c4
c5
c6
c7
c8
c9
a1
a2
a3
a4
a5
a6
a7
a8
a9
c10
c11
c12
c13
c14
c15
c16
c17
c18
c19
c20
c21
c22
c23
c24
c25
c26
c27
c28
c29
c30
c31
c32
a10
a11
a12
a13
a14
a15
a16
a17
a18
a19
a20
a21
a22
a23
a24
a25
a26
a27
a28
a29
a30
a31
a32
PHCL Lift Motor Speed Control Signal

PHCR Rotation Motor Speed Control Signal
PLL Compression Lower Limit
PLSL Lift Motor Pulse Sensor
PLSR Rotation Motor Pulse Sensor
PRE LEFT Compression Left Pedal Signal
PRE RIGHT Compression Left Pedal Signal
PRL Compression Release Limit sensor
PUL Compression Upper Limit
PWF Pulse Width Force Sensor
REL LEFT Release Left Pedal Signal
LIFT REFERENCE SENSOR
Code 7827716
REL RIGHT Release Right Pedal Signal

ROB Rotation Bottom Limit
REAR CPU PCB
ROR Rotation Reference Signal

ROU Rotation Upper Limit WHT +VAS
3
GRN LIR
RX RS-232 Receive Data
20010276
2
BRN 1 GND
SCNT Sensor Control

SCA I²C Bus Data
SCL I²C Bus Clock
SRL Serial Remote Line
STOP Stop Signal
SYNC Mains Syncronisation Signal
Code 7827741
TX RS-232 Transmit Data

Code 7827749
+VAS
LIU
LIFT UP LIMIT GND Code 20007240 ROTATION REFERENCE PCB
+VAS 1 RED
LIFT DOWN LIMIT LID 2 BLK Code 7827716

GND
WHT +VBS
3
GRN
2 ROR
BRN
1 GND
2 BLK
1 RED
YEL /GRN
Code 7827715
ROTATION DRIVE PCB
Code 7827739
P4
SYNC BLK +VAS
1
PLSR BRN
2 ROU
STOP 3 RED
YEL GND
YEL /GRN
+VCC 4
PHCR 5 GRN
SCNT 6 BLU
GND 7 WHT
DIRR 8
PURP ROTATION UP LIMIT
Exposure switch
20008285
P5
MAINS INPUT RED
- 1
GRN
208 VAC - 240 VAC + 2
YEL
A 3
50 / 60 Hz B 4
BLU
121-10-43
EXP2 PCB
MOTOR TEMP. SW
P8
≈
1
2
J1
Code 20008398
Code 20008400
REMOTE CONTROL RJ-12

Code 20008399
1 EXP
Brown
Blue
2 +VCC
Yell/Green
3
4
5 ELMP
6 SRL
Exposure Spiral
Cable 20008286
Code 20009964
BRN
BLU
(PE wire 5 passes through

Code 20003347 EMI toroid)
15A SLOW BLOW
15A SLOW BLOW
NOTE
N1
N2
Code 20000136
L
P6 1 2 3 4
Cross connected Cable
REMOTE CONTROL DIN-5
BRN
BLU
BLK
Code 20003347 ROTATION MOTOR

RED
ROTATION
1 +VCC
BA + -
GRN
2 EXP
Code 20008734 M YEL
BLU
PULSE
3 ELMP
4 GND
5 SRL
Code 20007211 BASE INTERFACE PCB

P1
WHT/GRN
BRN/GRN 1 ELMP MAXVIEW FOOTCONTROL
WHT/YEL 2 SRL
YELL /GRN
YEL/BRN 3 STOP
WHT/GRY 4 +VCC
GRY/BRN 5 EXP
Code 20000739
WHT/PNK 6 SCNT WHT GND
CLARITY MAINS FILTER PCB
PNK/BRN 7 GND 1
BRN UP
8 CLKL 2 GRN
9 DOWN
6 3 YEL
10 MAXIN
4 GRY
REL
MAINS 5 PINK PRE
Part No. 20009699
P6 P4
SWITCH +VCC
WHT
BRN
1 REL LEFT
109-10-57-C10
1 2 PRE LEFT
BRN GRN 3 REL RIGHT
L P5 YEL 4 PRE RIGHT MAXVIEW FOOTCONTROL
1 GRY 5 DSP
3 PNK 6 PHCL Code 20000739
Code 20004556 N
2
GND
BLU 7 DIRL WHT GND
RED 8 PLSL
3 BLK BRN UP
9 KEYL 1
VIO 2 GRN
10 TX DOWN
GRY/PNK 11 RX 6 3 YEL MAXIN
BLU/RED 4 GRY
BLU 12 DGND REL
5 PINK
Code 20003345 P3 PRE
BRN PLSL
1
RED +5V
2
YEL STOP
3
GRN +VCC
4
BLU PHCL
5
GRY DIRL
6
WHT GND
7
BLK 8 SCNT
YEL /GRN
P3
1 1 +VDC
2 2 -VDC
Code 20007287
MOTOR TEMP. SW 1 2 P9
P7
- RED 1
B BLK 2
A YEL 3
+ GRN 4
P1
BLU MAC P4
1 PLSL 1
BRN
BRN MAM RED
+VCC
2
GND
+5V 2
YEL
STOP 3
BLK MAS
3 +VCC 4
GRN wiring option 1
P10
BLU 6 5 4 3 2 1
4 PHCL 5
GRY
DIRL 6
BLU
RED
WHT
~
GND 7
LIFT MOTOR SCNT 8 BLK P7 to BASE DISPLAY J7
Code 20008733 M Code 20009647
+ -
AB
RED
Aux. Warning Light
BLK
YEL
GRN
BASE POWER PCB
Code 20007210 wiring option 2
LIFT
PULSE
Code 20000136 P7
~ Date Product
09.03.2017 Clarity Mammo Unit
Designer Name
Wiring diagram 1/3
J.Pennanen Compression Mechanism,
Sorvaajankatu 7 Drawn
00880 Helsinki Upper MaxView, Enhanced C-arm
H.Lehtinen Drive
Finland
Size Code
Tel. +358 20 7795 300
590 x 810 mm 20009472
Fax + 358 20 7795 309
Scale Drawing no.
www.planmed.com
1:1 7038-02-01-1/3 Rev. 1.3

Chapter H: DIAGRAMS

Chapter H: DIAGRAMS
J1 J2 J3
1 M5A1 M4A1 M6A1
1 1
M5A2 M4A2 M6A2
2 LEFT REAR
2 2
M5B1 M4B1 FRONT EDGE M6B1 RIGHT REAR
3 3 3
M5B2 M4B2 M6B2
4 4 4
109-10-96-A10
Code 20009852
UPPER LEFT KEYBOARD

UPPER RIGHT KEYBOARD
J4
1 RED
2 BLK
RED 8 GND
Code 20008690
BLU 7 +VCC J5
PINK 6 CRL M7A1
GRY 1
5 MRL M7A2
YEL 2
4 M/FC 3 M7B1 LAMP
GRN
3 F/C M7B2
BRN 4
2 SCL
WHT
1 EXP J6
1 M1A1
J8 M1A2
2 FILTER
M1B1
3
M1B2
4
J7
1 M0A1
M0A2
2 MIRROR
M0B1
3
M0B2
4
+VCC
CCW
DWN
GND
SAL
CW
UP
+VCC
CCW
DWN
GND
SAR
J1 1 2 3 4 5 6 7
CW
UP
PINK
WHT
GRN
GRY
BRN
BLU
YEL
J1 1 2 3 4 5 6 7
PINK
WHT
GRN
GRY
BRN
BLU
YEL
Code 20009108 Code 20008940
Code 20009108
Code 20008938
J12
M3A1
Code 20009142 Code 20008939
1
M3A2
Signals 2
3 M3B1 RIGHT EDGE
M3B2
Code 20009149
+VCC
4
CCW
DWN
GND
SAR
+VCC
Code 20008941
CCW
DWN
CW
GND
UP
SAL
J10
CW
UP
+VCC +33VDC Supply Voltage
WHT
BRN
PINK
RED
GRY
GRN
YEL
BLU
PINK
WHT
PINK
PINK
GRN
PINK
WHT
WHT
WHT
GRN
GRY
GRN
PINK
BRN
GRN
WHT
GRY
GRY
BRN
BRN
GRY
GRN
BRN
BLU
GRY
BRN
RED
YEL
BLU
BLU
BLU
RED
YEL
YEL
YEL
BLU
YEL
BLK
BLU
VIO
+VAA +15VDC Supply Voltage P13
P9 1 2 3 4 5 6 7 8 9 10 1 2 3 4 1 2 3 4 5 6 7 8 P17 P4 1 2 3 4 5 6 7 8 P6 1 2 3 4 5 6 7 8 P15 1 2 3 4 5 6 7 8 9 10 P18 1 2 3 4 5 6 7 8 9 10
-VBB -15VDC Supply Voltage
GND
+VCC
+VCC
+VCC
M/FC
GND
GND
SOC
MRL
EXP
EXP
CRL
SCL
SCL
SS1
SS2
SS3
F/C
X+
GND Ground P12
X-
P7
6 RED
GND 1
A(CDLL) Compression Encoder Output A 5 2
M2A1
4 3 2
BLU 3 CANL BLU Code 20009142 M2A2
B(CDLR) Compression Encoder Output B RED 2
CANH
+VCC 4 1
3 M2B1 LEFT EDGE
1 P2 4 M2B2
CANL CAN-Bus Low SYNC 1 WHT
BRN
P5 SCL 2
CANH CAN-Bus High BRN 1 DIRM STOP 3 GRN
YEL
WHT 4
2 ZERO +VCC
GRY
CCW C-Arm Counter Clockwise Rotation Signal EXP 5
WHT 6
1 MA2
BLU
CW C-Arm Clockwise Rotation Signal BRN
GRN
2 MSB1 GND 7
RED Code 20009671
3 NC PEN 8
YEL
BPL Bucky Position Limit GRY
4 +VAA
FAN
5 BRL
PINK
6
BRL Bucky Reference Limit BLU
7
EJER
CDSL
RED P3
8 MSA1 BLU
BVC Bias Voltage Control BLK
9 MB2
-FAN
+FAN
1
2 RED
VIO
10 +VCC
C/S Relay Collimator/Shelf Collector GRY/PINK
RED/BLU
11 BPL
WHT/GRN
12 CPL
TUBE POWER PCBPart No. 20007212
CDBL Cassette Big Limit BRN/GRN
13 CDBL PAPST 3414 NGM
14 GND
WHT/YEL
CDSL Cassette Small Limit YEK/BRN
15
16
STOP
EXP
WHT/GRY
17 MDL POWER SUPPLY Wire Hassle Cable
CPL Cassette Position Limit GRY/BRN
18 SCHEMATIC 64 Pin Ribbon Cable
WHT/PINK
SCL TUBEHEAD
19 MUL DIAGRAM
CRL Collimator Reference Limit PINK/BRN
20 EJEL (CONNECTORS) Code 20006431
MGEN
MSB1
+VCC
+VCC
SYNC
+VCC
MTB1
MTA1
CDSL
MSA1
PLSM
STOP
STOP
STOP
STOP
STOP
+VCC
+VCC
+VAA
+VAA
CDBL
+LMP
DIRM
M/FC
DWN
GND
GND
GND
GND
SOC
GND
GND
GND
GND
GND
MRL
MDL
MUL
MA2
MB2
MB2
MA2
BRL
CRL
EXP
FAN
PRE
PEN
FRL
SS3
CPL
REL
SCL
SCL
DIRA Anode Motor Direction
BPL
SS1
SS2
LRL
P11
L/B
F/C
UP
T+
X+
X-
DIRM Tilt Brake Control J6
a10
a11
a12
a13
a14
a15
a16
a17
a18
a19
a20
a21
a22
a23
a24
a25
a26
a27
a28
a29
a30
a31
a32
c10
c11
c12
c13
c14
c15
c16
c17
c18
c19
c20
c21
c22
c23
c24
c25
c26
c27
c28
c29
c30
c31
c32
a1
a2
a3
a4
a5
a6
a7
a8
a9
c1
c2
c3
c4
c5
c6
c7
c8
c9
DOWN Lift Down GND

+VCC
TUBE CONNECTOR PCB
+VAA
SAL Side Access Left Button -VBB
MAC c32
SAR Side Access Right Button +LMP MAC a32
c30
EXP Exposure K2 VR6
a30
ANODE
F/C Relay Filter/Collimator D27

MAS
MAS
c28
a28
M MOTOR
R62
HST MAM c26
MAM
FAN +24VDC to Fan P4 FAN
a26
c24
DIRA a24
FEX Foil Exchange Button
TO POWER SUPPLY PCB J5

PHCA
PLSA c22
KVC a22
FIC Filament Common HEN HV2 c20
EXP HV2 a20
LAMP
FILF Filament Large Focus BVC
SFE HV2
c18
a18
LFE
FISF Filament Small Focus VFC
HV1 c16
a16
FILF
FIC HV1 c14
FRL Filter Reference Limit FISF HV1 a14
MAF+ HV-TRANSFORMER
MAF- c12
HEN H-Bridge Enable KVF+ a12
KVF-
c10
HST Heat Sink Temperature FILF
a10
c8
a10
a12
a13
a14
DIRA a15
PHCA a16
MGEN a17
DIRM a18
STOP a19
a20
a21
a22
a23
a24
SYNC a25
a26
LAMP a27
a28
a29
a30
MAF+ a31
KVF+ a32
c32
c10
c12
c13
c14
c15
c16
PLSA c17
PLSM c18
c19
c20
c21
DWN c22
c23
c24
c25
c26
c27
c28
c29
c30
MAF- c31
CDBL a11
CDSL c11
J4
a2
a3
a4
a5
a6
a7
a8
a9
c1
c2
c3
c4
c5
c6
c7
c8
c9
a1
KVC Kilovolt Control BIAS

FIC
a8
c6
+VCC
+VAA
+VAA
M/FC
-VBB
KVF-
GND
GND
SOC
FISF
MRL
MUL
MDL
HEN
MB1
MB2
MA1
MA2
PRE
KVC
PEN
BVC
FILF
CRL
HST
FAN
EXP
VFC
BRL
CPL
REL
SCL
SFE
FRL
BPL
SS1
SS2
SS3
GTI
LRL
LFE
FISF
C/S
F/C
FIC
KVF- Kilovolt - Feedback
L/B
a6
UP
X+
T+
X-
MAF- c4
TO TUBE CPU STAND PCB P1 MAF+
a4
KVF+ Kilovolt + Feedback KVF- c2
a17 MGEN
a16 PHCA
SYNC
c7 +VCC
c18 PLSM
LAMP
a11 CDBL
c11 CDSL
a19 STOP
c17 PLSA
a18 DIRM
a7 +VAA
c8 +VAA
FISF-
a5 M/FC
a15 DIRA
c22 DWN
FILF-
a8 -VBB
a6 GND
c6 GND
FIC+
c14 SOC
a4 MRL
KVF+
a20 MUL
c20 MDL
c23 HEN
a1 MB1
c1 MB2
a2 MA1
c2 MA2
MA+
a21 PRE
a23 KVC
PEN
BVC
c3 CRL
c5 HST
EXP
VFC
c9 BRL
c10 CPL
c21 REL
SCL
FAN
SFE
a3 FRL
a10 BPL
a12 SS1
a13 SS2
c13 SS3
KV+
a9 LRL
LFE
MA-
GTI
c16 C/S
a2
c4 F/C
KV-
c12 L/B
a22 UP
c15 X+
c19 T+
L/B Relay Labeling/Bucky

a14 X-
a24
a25
a26
a27
a28
a29
a30
a31
a32
c32
c24
c25
c26
c27
c28
c29
c30
c31
TUBE CPU STAND PCB
LAMP On/Off Signal to Lamp

LFE Large Focus Enable
LRL Labeling Reference Limit
M/FC Relay Mirror/Filter or Collimator D1
MAF- Milliamp - Feedback D2
MAF+ Milliamp + Feedback

D3
ANODE MOTOR STATOR RESISTANCE
MDL MAG Down Limit D4
MGEN MAG Enable Signal TUBE a28 - a32 a26 - a32

D5
MLFB MaxView Lower Foil Backward Button Toshiba 7272 57ohm 27ohm
4 mA-
MLFF MaxView Lower Foil Forward Button R2
3 mA+ Toshiba 7290 28ohm 10ohm
2 kV-
9 10 11 12 13 14 15 16 10 9 12 11 14
MRL Mirror Reference Limit R1
1 kV+ Varian M113SP 46ohm 15ohm
RN2 RN1
MUFB MaxView Upper Foil Backward Button 8 7 6 5 4 3 2 1 7 8 5 6 3

a10
a12
a13
a14
a15
a16
a17
a18
a19
a20
a21
a22
a23
a24
a25
a26
a27
a28
a29
a30
a31
a32
c32
c10
c12
c13
c14
c15
c16
c17
c18
c19
c20
c21
c22
c23
c24
c25
c26
c27
c28
c29
c30
c31
a11
MUFF MaxView Upper Foil Forward Button

c11
a2
a3
a4
a5
a6
a7
a8
a9
c1
c2
c3
c4
c5
c6
c7
c8
c9
a1
MGEN
PHCA
SYNC
LAMP
PLSM
+VCC
+VCC
STOP
CDSL
CDBL
DIRM
PLSA
+VAA
FISF-
M/FC
DIRA
DWN
FILF-
-VBB
GND
GND
FIC+
SOC
MUL
MDL
MRL
HEN
MA+
MB1
MB2
MA1
MA2
PEN
PRE
BVC
KVC
HST
EXP
CRL
VFC
SCL
FAN
BRL
CPL
REL
SFE
KV+
SS1
SS2
SS3
FRL
BPL
LRL
LFE
MA-
MUL MAG Upper Limit

GTI
C/S
F/C
KV-
L/B
UP
X+
T+
X-
NAS Needlequide Assembled YEL/GRN
DIP-SWITCH
PEN Power Enable
POSITIONS Code 20007240 BLK
3
2
PHCA Anode Motor Phase Control 1
RED
PLSA Anode Motor Pulse CLARITY

S1 YEL/GRN
PLSM Pulse MAG

2 1
PRE Press
REL Release
CLARITY TUBE CPU PCB Part No. 20010273
ON
SCL Serial Communication Line
SFE Small Focus Enable
SOC Sensor Offset Control
CLARITY
SS1 AEC Sensor Select 1 S2
SS2 AEC Sensor Select 2
TO REAR INTERFACE PCB J3
ON
SS3 AEC Sensor Select 3
TO BASE POWER PCB P3
STOP Stop
1 2
SYNC Syncronize Pulse
T+ Tubehead Temperature Signal
T- Tubehead Temperature GND
UP Lift Up
VFC Voltage Filament Control
X- AEC Measurement Signal
X+ AEC Measurement Signal
XLL MaxView Lower Module Reference Sensor
TO COMPRESSION CONNECTOR PCB J1
XUL MaxView Upper Module Reference Sensor
TO COMPRESSION MOTOR
ZERO Tilt Zero Angle Information
RED
BLU
TO PIM PCB J5
J1 1 2 3 4
+VCC
GND
RED
BLU
J1 1 2 3 4
a1 MB2 a1 MXC2
+VCC
GND
b1 NC b1 NC
c1 MSB1 c1 MXD2
a2 MA2 a2 MXC1
b2 NC b2 NC
c2 MSA1 c2 MXD1
a3 GND a3 MUFF
b3 GND b3 NC
c3 GND c3 GND Code 20002672
a4 SCL a4 MLFF
b4 EXP b4 NC
WHT 1 Ground
c4 STOP c4 MUFB 1
a5
BRN 2 NC
CPL a5 XLL 3
b5 CDBL b5
GRN
4 3 Output A
NC
YEL 4 + Vcc
c5 BPL c5 MLFB 5
a6 CDSL a6 NC 5 Output B
b6 +VCC b6 NC
c6 EJER c6 FEX
a7 BRL a7 +VAA (MAXVIEW)
b7 +VCC b7 NC
COMPRESSION ENCODER
c7 EJEL c7 +VAA (BUCKY)
a8 GND a8 +VCC
b8
LOWER LEFT KEYBOARD c8
NC b8 NC
GND c8 +VCC
a9 MDL a9 LSB
b9 NC b9 NC LOWER RIGHT KEYBOARD
c9 MUL c9 CPLR
a10 NC a10 CPLL
b10 +VAA (MAG LOW) b10 NC
c10 +VAA (MAG UP) c10 BRL
a11 +VAA (MAXVIEW) a11 BPL
b11 NC b11 NC
c11 FEX c11 SPLS2
a12 XUL a12 STOP
b12 NC b12 NC
c12 MLFB c12 SLIM1
a13 MLFF
b13 NC
20010277 a13 NC
b13 NC
c13 MUFB c13 SLIM2
a14 MUFF a14 GND
b14 NC b14 NC
c14 GND c14 GND
a15 MXXA1 a15 MA2
b15 NC b15 NC
c15 MXXB1 26 Pin Ribbon Cable c15 MSA1
a16 MXA2 a16 MB2
b16 NC
Code 20002678
b16 NC
c16 MXB2 c16 MSB1
Code 20009445
+VCC
CCW
DWN
GND
SAL
CW
UP
J1 1 2 3 4 5 6 7 Code 20002674
+VCC
CCW
DWN
GND
SAR
CW
UP
PINK
WHT
GRN
GRY
BRN
BLU
YEL
Code 20002673 Code 200026659 J1 1 2 3 4 5 6 7

PINK
Code 20002664
WHT
GRN
GRY
BRN
BLU
YEL
STEREO/SIDE ACCESS MOTOR

DIP-SWITCH Code 20002685
Code 20003365 Code 20008939
POSITIONS
GRY/PINK
RED/BLU
WHT/PINK
WHT/PINK
WHT/GRY
PINK/BRN
WHT/GRN
GRY/PINK
WHT/GRY
PINK/BRN
WHT/GRN
GRY/BRN
BRN/GRN
GRY/PINK
GRY/BRN
BRN/GRN
WHT/YEL
YEK/BRN
WHT/YEL
YEK/BRN
RED/BLU
RED/BLU
CLARITY
PINK
WHT
GRN
GRY
BRN
RED
WHT
BLU
GRN
YEL
BLK
BRN
YEL
VIO
PINK
WHT
GRN
PINK
GRY
WHT
WHT
BRN
RED
GRN
GRY
GRN
BRN
RED
BLU
YEL
BLK
BRN
YEL
BLU
YEL
BLK
VIO
VIO
S2
GREEN WHITE
RED WHITE
P3 1 2 3 4 5 6 7 8 9 1011 1213141516 17181920 P4 1 2 3 4 P8 1 2 3 4 5 6 7 8 9 101112 P9 1 2 3 4 P1 1 2 3 4 5 6 7 8 9 1011 1213141516 17181920

1
+VAA
MXXB1
MXXA1
GREEN
MPA1
MPA2
CDLR
MPB1
MPB2
STOP
PWF
GND
+VAA
CDLL
FMS
MPB1
MPB2
MPA1
MPA2
ON
STOP
CDBL
MSB1
MSA1
GND
+VCC
CDSL
MUFB
MXB2
MXA2
MUFF
+VAA
EJER
+VAA
EJEL
MLFB
MLFF
PUL
PRL
+VAA
+VAA
GND
PLL
MDL
MUL
PWF
GND
SCL
EXP
MA2
MB2
GND
GND
BRL
CPL
FMS
PUL
BPL
RED
FEX
XUL
PLL
NC
P5 J1 1 2 3 4
6
MSA1
MSB1
MA2
MB2
5
4 J2
CANL 3 BLU WHT
RED +VCC 1
CANH 2 BRN
1
NAS 2
GRN
SPLS2 3
YEL
P6 STOP 4
GRY
6 SLIM1 5
PINK
5 SLIM2 6
BLU
4 SPLS1 7
RED
CANL 3 BLU SPL 8
RED BLK
CANH 2 +5V 9 VIO
1 0° 10 GRY/PINK
11
RED/BLU
P10 CPLCTRL 12
WHT/GRN
6 L/B 13 BRN/GRN
B(CDLR) 5 BRN GND 14
WHT/YEL
TO CYTOGUIDE CONTROL PCB
+5V 4 GRN MSA1 15

YEL/BRN
A(CDLL) 3 YEL MA2 16
WHT/GRY
2 MSB1 17
WHT GRY/BRN
GND 1 MB2 18
J3
WHT
P17 BRK 2
DIRM 1 BRN
+VCC 1
WHT BRAKE
WHT
ZERO 2
Code 20002686
CPLCTRL
GNDS
+VSS
SLIM2
SLIM1
SPLS2
SPLS1
GND
BRAKE
SLIM1
SLIM2
MSB1
MSA1
NDL
STR
STOP
+VCC
GND
Code 20009449
GND
MB2
+5V
MA2
NAS
SPL
+5V
L/B
0°
MUFB
0°
MUFF
MUFB
MLFB
MUFF
MXD2
MXD1
MXC2
MXC1
RELEASE
MLFF
MLFB
MLFF
+VAA
GND
GND
FEX
FEX
XLL
J4 1 2 3 4 5 6 7 8 J5 1 2 3 4 5 6
GRY/PINK
RED/BLU
PURP
RED
BLU
PINK
GRY
YEL
GRN
BRN
WHT
YEL/BRN
WHT/YEL
BRN/GRN
WHT/GRN
BLK
P12 1 2 3 4 5 6 7 8 9 1011 1213141516 1718

WHT/PINK
BUTTON
WHT/PINK
GRY/BRN
P11 1 2 3 4 5 6 7 8 P10 1 2 3 4 5 6 7 8 9 101112

RED/BLU
PINK
WHT
GRN
GRY
BRN
RED
WHT/GRY
WHT/GRN
BLU
YEL
GRY/PINK
GRY/BRN
BRN/GRN
WHT/YEL
YEK/BRN
RED/BLU
GRY/PINK
WHT
RED/BLU
BRN
BLU
PINK
WHT
GRN
GRY
BRN
RED
BLU
YEL
BLK
VIO
18
17
16
15
14
13
12
11
10
PINK
WHT
9
8
7
6
5
4
3
2
1
GRN
PINK
WHT
VIOL
GRY
BRN
GRN
GRY
BRN
RED
YEL
BLU
YEL
BLK
18
17
16
15
14
13
12
11
10
9
8
7
6
5
4
3
2
1
GRY/PINK
RED/BLU
PURP
RED
BLU
PINK
GRY
YEL
GRN
BRN
WHT
YEL/BRN
WHT/YEL
BRN/GRN
WHT/GRN
BLK
WHT/PINK
Code 20002666 Code 20009448

WHT/PINK
WHT/GRN
GRY/BRN
BRN/GRN
WHT/PNK
GRY/PNK
WHT/YEL
RED/BLU
RED/BLU
YEL/BRN
PURP
WHT
WHT
GRN
GRY
BRN
BRN
RED
PNK
BLU
BLU
YEL
BLK
PINK
WHT
WHT
GRN
GRN
GRY
BRN
RED
BRN
BLU
YEL
YEL
1 2 3 4 5 6 7 8 9 1011 1213141516 17181920 21222324

1 2 3 4 5 6 7 8 9 1011121314
GND
+5V
+8V
XM
YM
ZM
YD
NS
XC
YC
XA
YP
XB
ZC
ZA
ZB
MUFB
MUFF
MXD2
MXD1
MXC2
MXC1
MLFB
MLFF
+VAA
GND
FEX
XLL
1 2 3 4 5 6 7 8 9 1011 1213141516 17181920 21222324

WHT/GRN
BRN/GRN
WHT/PNK
WHT/PNK
GRY/BRN
GRY/PNK
WHT/YEL
RED/BLU
RED/BLU
YEL/BRN
PURP
WHT
WHT
GRN
GRY
BRN
RED
BRN
PNK
BLU
BLU
YEL
BLK
Code 20009447
WHT/GRN
GRN
BRN/GRN
WHT/GRY
WHT/YEL
GRY/PNK
GRY/BRN
YEL/BRN
RED/BLU
1 GND
BRN
PURP
2 XLL
WHT
GRN
RED
GRY
BRN
WHT
PNK
BLK
BLU
YEL
3 +VAA
Code 20002679
1 2 3 4 5 6 7 8 9 1011 1213141516 17181920 21222324 25262728

GND
+8V
+5V
XC
YC
ZC
XM
YM
XB
NS
ZM
ZB
YP
YD
XA
ZA
1 2 3 4 5 6 7 8 9 1011121314 MAXVIEW LOWER MODULE

J1 1 7 14
WHT
WHT
WHT
GRN
GRN
GND
BRN
BRN
1
YEL
BRN
Code 20002667 SLIM2 2
GRN
0° 3
SLIM1 YEL
4
GRY 28 15
5
PINK
Code 20002668 6
PINK
WHT
BLU
GRN
GRY
BRN
YEL
7
RED
WHT
GRN
BRN
+5V
YEL
8
6 5 4 3 2 1
MUFB
MUFF
MLFB
MLFF
3
5
7
9
GND
FEX
LOWER MAXVIEW Date Product

MXC1
MXC2
MXD1
MXD2
6 5 4 3 2 1
MOTOR 28.10.2016 Clarity Mammo Unit
Designer Name
Wiring diagram 2/3
J.Pennanen
Sorvaajankatu 7 Drawn
Tubehead, Lower MaxView,
00880 Helsinki H.Lehtinen Breast Support
MUFB
MUFF
MLFB
MLFF
Finland
GND
FEX
Size Code
Tel. +358 20 7795 300
590 x 780 mm 20009473
Fax + 358 20 7795 309
Scale Drawing no.
www.planmed.com
1:1 7038-02-01-2/3 Rev. 1.2

Chapter H: DIAGRAMS

Chapter H: DIAGRAMS
Left Touch Panel Right Touch Panel
Code 20009168 Code 20009167
J5
1
2
1 +VCC Code 20009649
2 GND
3
4
5
6
To Base Ethernet Connector “CONTROL”
Code 20009648
To Rear Interface PCB Code 20009345
Code 20009356
Code 20009355
Code 20009649
RED
1
GRN COM
BLU
Code 20008869
To Shelf CPU Interface PCB RED

GRN
1 BOOT +24VDC 1
BLU
2 RED
EXP GND 2
BLU
To Compression Connector PCB 3 CAL
J2
J1
To Tubehead Interface PCB Code 20009149 VIO FAN PAPST 614 NGHH 24VDC 3,6W
1 EXP
BLK Code 20009343
To Ethernet Switch PCB RED
2
3
MSCL
SS3
BLU
4 SS2
To Rear Interface PCB PINK
5 SS1
GRY
6 SOC
To Rear Interface PCB YEL
7 GND
GRN
BRN
8 +VCC
To Base Ethernet WHT 9 X+
10 X-
Connector J5
“DETECTOR”
Code 20009146
Code 20009648
Signals BLK Code 20009148
GND 1
BRN
SCL 2
RED
+VAA +15VDC Supply Voltage SDA
+5V
3
ORG
4
+VCC +33VDC Supply Voltage J22
RED
+5V 1
+32V +VCC 1 2 BLU
GRN
2 3
+24VDC 24VDC Detector Supply Voltage 4 4 YEL
WHT
8 5
+5V +5VDC Supply Voltage 6
7
VREF 2,5V Reference Voltage 8
9 BLK
GND Ground Code 20002686 GND 10
WHT
1 J19
BOOT Software Load Mode Signal BRAKE WHT
2
+32VDC
BRK RED
GND 1
BLU
BRK Brake Control J25 SCL 2
GRN
SDA 3
YEL
BRL Bucky Reference Limit RED
+5V 4
Code 20009145
1 GND J21
CAL Calibration Mode Signal GRN
2 CPOS
WHT
BLU
GRN
RED
BLU
BLK
YEL
3 VREF
CANH CAN-Bus High Wire Code 20009673 J27 Code 20009341
J1 1 2 3 4 5 6
CANL CAN-Bus Low Wire 1 PREP_P
GND
+5V
WHT/GRN
GRY/PINK
2
RED/BLU
CPOS Compression Position Signal PREP_M

8
4
2
1
3
WHT
GRN
BRN
EXP_REQ_P
VIO
4 EXP_REQ_M
EXP Exposure Signal 5 GND
J1 3 5 7 9
1
2
3
6 EXP_OK_M
MSCL Mammo Serial Communication Signal RED 7 EXP_OK_P
+VAA
MSA1
MSB1
GND
BRL
MA2
MB2
BLU 8 HKD_M
SCL I²C-Bus CLK signal GRN 9 +5V
PartNo. 20000854
SCA I²C-Bus Data Signal J14

BLU, RED
109-10-42-A
SOC AEC Sensor Offset Control YEL, GRN

1
2
+24VDC
GND
SS1 AEC Sensor select 1 J15
1
SS2 AEC Sensor select 2 1 +32V
Code 20008809 2
2
SS3 AEC Sensor select 3 3 GND
J16
X- AEC Measurement Signal
1
RED
X+ AEC Measurement Signal BLUE
2 CANH
3 CANL
1 Platform Recognition Signal D 4
5
Code 20009147 GREEN
2 Platform Recognition Signal C 6 GND
J17
4 Platform Recognition Signal B
Code 20009143
8 Platform Recognition Signal A Code 20009144

GRN
RED
BLU
YEL
9
8
7
6
5
4
3
2
1
1 2 3 4
+24VDC
+24VDC
+5V
HKD_M
EXP_OK_P
EXP_OK_M
GND
EXP_REQ_M
EXP_REQ_P
PREP_M
PREP_P
GND
GND
Varian 3024M Flat Panel

+5V
SDA
SCL
GND
J21 4 3 2 1
YEL
BLU
RED
GRN
Code 20009446
Platform Recognition
ID MAGNETS:
NAME:
NUMBER: A B C D
1 Clarity Bucky 24x30 - - - X
2 Clarity Tomosynthesis platform - - X -
3 Clarity MAG platform 1.6 - - X X
4 Clarity MAG platform 1.8 - X - -
5 -
6 Clarity biopsy platform - X X -
7 -
8 -
9 -
10 -
Base Display
Code 20009694
Code 20009698
BLU
GND 1
RED
+VCC 2
3
4
5 Code 20009647
6
7
8
To Base Interface PCB P10 Date
20.05.2015
Product
Clarity Mammo Unit
Designer Name
Code 20009719 J7 H.Lehtinen Wiring diagram 3/3
Sorvaajankatu 7 Drawn Clarity Head
00880 Helsinki H.Lehtinen with PIM and Power Supply
Finland
Size Code
Tel. +358 20 7795 300
420x594 mm 20009474
Fax + 358 20 7795 309
Scale Drawing no.
www.planmed.com
7038-02-01-3/3 Rev. 1.1

Chapter H: DIAGRAMS

Planmed Oy | Sorvaajankatu 7 | 00880 Helsinki | Finland
tel. +358 20 7795 300 | fax +358 20 7795 664 | [email protected] | www.planmed.com

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What are the main components of the Planmed Clarity FFDM system?

What are the main components of the Planmed Clarity FFDM system?

What safety warnings and precautions are mentioned?

What safety warnings and precautions are mentioned?

Planmed Clarity ™

Chapter A: GENERAL & TECHNICAL DATA

Chapter B: CONTROL PANEL DISPLAYS

Technical manual Planmed Clarity 2D/3D 1

2.1.3 To exit SERVICE & CONFIGURATION menu ........................................................... 49

Chapter C: PREVENTIVE MAINTENANCE

Chapter D: ADJUSTMENT & CALIBRATION

2 Planmed Clarity 2D/3D Technical manual

6 CALIBRATING AND VERIFYING X-RAY FIELD SIZE ....................................................... 107

Chapter E: PARTS REPLACEMENT AND REPAIR

Chapter F: PLANMED CLARITY MANAGER

Technical manual Planmed Clarity 2D/3D 3

2.1.2 Imaging / Quality Control .......................................................................................... 164

Chapter G: PLANMED CLARITYGUIDE

4 Planmed Clarity 2D/3D Technical manual

Planmed pursues a policy of continual product development. Although every effort is

Technical manual Planmed Clarity 2D/3D 5

6 Planmed Clarity 2D/3D Technical manual

1.1 Associated documentation

Technical manual Planmed Clarity 2D/3D 7

1.2 How to find information in this manual

Chapter A: "GENERAL & TECHNICAL DATA" on page 7 (this

Chapter B: "CONTROL PANEL DISPLAYS" on page 43

Chapter C: "PREVENTIVE MAINTENANCE" on page 67

Chapter D: "ADJUSTMENT & CALIBRATION" on page 81

Chapter E: "PARTS REPLACEMENT AND REPAIR" on page 129

Chapter F: "PLANMED CLARITY MANAGER" on page 157

Chapter G: "PLANMED CLARITYGUIDE" on page 197

Chapter H: "DIAGRAMS" on page 221

8 Planmed Clarity 2D/3D Technical manual

2 PLANMED CLARITY FFDM SYSTEM

2.1 System setups

Technical manual Planmed Clarity 2D/3D 9

Figure 2: Planmed Clarity FFDM/DBT system, an optional setup

Item Cables, length (part number)

10 Planmed Clarity 2D/3D Technical manual

Technical manual Planmed Clarity 2D/3D 11

2.2 Mammography unit

1. C-arm 2. Touch screen

12 Planmed Clarity 2D/3D Technical manual

2.3 Characteristics of use

Imaging view and

2. AWS focuses on patient information and the acquired images.

Technical manual Planmed Clarity 2D/3D 13

14 Planmed Clarity 2D/3D Technical manual

3 WARNINGS AND PRECAUTIONS

Periodic maintenance as described in this manual must be performed on a regular

Technical manual Planmed Clarity 2D/3D 15

16 Planmed Clarity 2D/3D Technical manual

4 SYMBOLS AND PRODUCT LABELS

4.1 Symbols on product labels

Type B applied part (Standard IEC 60601-1).

Alternating current (Standard IEC 60601-1).

Attention, consult accompanying documents (Standard IEC 60601-1).

X-ray source assembly: emitting (Standard IEC 60417).