Optikon Hiscan Installation and Operation Manual 102

Cod 14101XEN
2014-09-02 Rev.B
HiScan
A/BSCAN ECHOGRAPH
INSTALLATION AND OPERATION MANUAL
OPTIKON 2000 S.p.A.

Via del Casale di Settebagni, 13 - 00138 Rome
Tel. +39 06 8888355 - Fax. +39 06 8888440
E-mail [email protected] - www.optikon.com
ì
OPTIKON 2000 S.p.A. is an ISO 9001 and ISO 13485 certified company
that manufactures surgical and diagnostic devices for ophthalmology.
All OPTIKON 2000 products are manufactured in compliance with the

requirements of Directive 93/42/EEC concerning medical devices.
TABLE OF CONTENTS
PAGE
1 DISCLAIMER ................................................................................. 1-1
2 LIMITED WARRANTY CONDITIONS ............................................ 2-1
3 WARNINGS ................................................................................... 3-1
4 SYMBOLS ..................................................................................... 4-1
5 GENERAL INFORMATION ............................................................ 5-1
5.1 SYSTEM DESCRIPTION ............................................................. 5-1
5.2 TECHNICAL SPECIFICATIONS ..................................................... 5-4
5.3 ELECTROMAGNETIC COMPATIBILITY TABLES................................. 5-10
5.3.1 GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS .... 5-10
5.3.2 GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY .... 5-11
5.3.3 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF
COMMUNICATION EQUIPMENT AND HISCAN .............................................................. 5-12
5.4 CIRCUIT DIAGRAMS .............................................................. 5-13
6 INSTALLATION ............................................................................. 6-1
6.1 INTRODUCTION .................................................................... 6-1
6.2 UNPACKING AND INITIAL INSPECTION .......................................... 6-1
6.3 INSTALLATION PROCEDURE ...................................................... 6-2
6.4 Audible signals..................................................................... 6-4
6.5 How to connect a videoprinter.................................................. 6-4
6.6 Leakage currents in presence of single points of failure .................... 6-5
6.7 Updating the device software ................................................... 6-6
7 USING THE DEVICE...................................................................... 7-1
7.1 User Interface ..................................................................... 7-1
7.1.1 Main menu ............................................................................................ 7-1
7.1.2 BSCAn ................................................................................................. 7-2
7.1.3 Dropdown menu ..................................................................................... 7-4
7.1.4 Biometry .............................................................................................. 7-7
7.1.5 Diagnostic Ascan ................................................................................... 7-14
7.1.6 Pachymetry.......................................................................................... 7-15
7.1.6.1 Warning .......................................................................................... 7-15
7.1.6.2 User interface .................................................................................. 7-15
7.1.6.3 How to operate the device in a pachymetry environment ............................. 7-17
7.1.6.4 Settings of the parameters ................................................................... 7-19
7.1.6.5 Calibrating the pachymeter .................................................................. 7-22
8 OPERATION .................................................................................. 8-1
8.1 SELF-TEST SESSION ................................................................ 8-1
8.2 BIOMETRY PROBE TEST ........................................................... 8-2
8.3 Features ............................................................................ 8-3
8.3.1 Operator .............................................................................................. 8-4
8.3.2 Print ................................................................................................... 8-4
8.3.3 Reset .................................................................................................. 8-8
8.3.4 Keyboard.............................................................................................. 8-8
8.3.5 Record................................................................................................. 8-9
8.3.6 Play .................................................................................................... 8-9
8.3.7 3D ...................................................................................................... 8-9
8.3.8 Zoom .................................................................................................. 8-9
8.3.9 Gain................................................................................................... 8-10
8.3.10 Delay ............................................................................................. 8-10
8.3.11 Image size ....................................................................................... 8-10
8.3.12 Scan Rate ........................................................................................ 8-10
8.3.13 Pulse .............................................................................................. 8-11
8.3.14 Velocity .......................................................................................... 8-11
8.3.15 Image ............................................................................................. 8-11
8.3.16 Filters ............................................................................................ 8-12
8.3.17 Search Function ................................................................................ 8-12
8.3.18 DB (DATABASE) ................................................................................. 8-13
8.4 Using the device................................................................. 8-16
8.4.1. GENERAL INSTRUCTIONS ...................................................................... 8-16
8.4.2. HOW TO USE B-SCAN........................................................................... 8-17
8.4.3. HOW TO USE THE ASCAN FUNCTION IN BSCAN MODE .................................... 8-19
8.4.4. HOW TO USE THE BIOMETRY FUNCTION .................................................... 8-19
8.4.5 USING THE FOOTSWITCH .......................................................................... 8-22
8.5 SHUTDOWN PROCEDURE ....................................................... 8-23
9 CLEANING, STERILIZATION AND MAINTENANCE .................... 9-1
9.1 CLEANING .......................................................................... 9-1
9.1.1 DEVICE ................................................................................................ 9-1
9.1.2 ACCESSORIES ......................................................................................... 9-1
9.2 STERILIZATION ..................................................................... 9-1
9.2.1 DEVICE ................................................................................................ 9-1
9.2.2 Accessories ........................................................................................... 9-1
9.3 Reducing the risk of infections .................................................. 9-1
9.4 MAINTENANCE ..................................................................... 9-2
9.4.1 DEVICE ................................................................................................ 9-2
9.4.2 Accessories ........................................................................................... 9-2
10 TROUBLESHOOTING GUIDE ..................................................... 10-1
11 APPENDIX 1 - 3D IMAGING SOFTWARE .................................. 11-1
11.1 INTRODUCTION .................................................................. 11-1
11.2 DESCRIPTION OF THE 3D SOFTWARE ......................................... 11-3
11.3 HOW TO USE THE 3D RECONSTRUCTOR ..................................... 11-11
11.4 TROUBLESHOOTING AND CORRECTING IMAGE ADJUSTMENT DEFECTS.. 11-13
HiScan Touch Installation and Operation Manual
OPTIKON 2000
1 DISCLAIMER
OPTIKON 2000 S.p.A. requires the user of this device to carefully read the specific
warnings contained in this manual. It is responsibility of the user to ensure that all the
operators are familiar with the operation of the device before use. In no event shall
Optikon 2000 S.p.A. be liable for any injury, incidental or consequential damages
incurred by the purchaser, users or patients as a result of the use of the product.
The use of this device is a matter of professional medical judgment. Optikon 2000
S.p.A. is not responsible for any clinical problem resulting from mishandling this
device and makes no medical recommendations.
OPTIKON 2000 S.p.A. declares to be responsible for the safety, reliability and
performance only if:
• Updates, calibrations and reparations are carried out by personnel specifically
authorised by OPTIKON 2000 S.p.A.
• The device is used in compliance with the user instructions
• The mains electric installation to which the device is connected complies with
the EN Safety Regulations.
IMPORTANT NOTICE:
Every effort has been made so that all the illustrations and information
precisely represent the product and its operation as they were at the time this
manual was printed. It is possible, however, that during the existence of this
manual modifications have been made in order to continue to effectively
satisfy the needs of the users. At times, such modifications are made without
advance notice.
OPTIKON 2000 S.p.A.

Via del Casale di Settebagni, 13
00138 Rome - Italy
Tel. +39 06 8888355
Fax. +39 06 8888440
E-mail [email protected]
www.optikon.com
NOTE
The information contained in this manual is exclusive property of OPTIKON
2000 S.p.A. Partial or total reproduction of this manual is permitted only upon
written authorisation by OPTIKON 2000 S.p.A.
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THIS PAGE HAS BEEN INTENTIONALLY LEFT BLANK
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2 LIMITED WARRANTY CONDITIONS

All OPTIKON 2000 S.p.A. instruments and accessories sold and installed in the European
Union are guaranteed against manufacturing and material defects for ONE YEAR from the
invoicing date. Warranty on consumable material is limited to the first use of the
device.
For information on the warranty conditions outside the European Union, contact your
authorised OPTIKON 2000 S.p.A. distributor.
All items covered by the warranty will be repaired or replaced free of charge..
Warranty includes the research of causes of the faults, reparation of the defect and a final
inspection of the device or its part(s).
This warranty does not cover any problems which are the result of improper use, accidents,
incorrect use and tampering or modifications made by persons who are not part of the
authorised OPTIKON S.p.A. technical support.
OPTIKON 2000 S.p.A. reserves the right to verify, in case of failures, if the device and/or its
accessories have been modified or tampered with in any way, or if they have been damaged
by improper use.
OPTIKON 2000 S.p.A. also reserves the right to modify the device and/or its accessories in
the event operating techniques require such modifications.
The warranty is not valid if the serial number of the device and/or accessories attributed by
OPTIKON 2000 S.p.A. is missing, tampered with and/or unreadable.
The warranty does not include the expenses for returning the device and accessories:
all charges for shipping, packaging, etc. shall have to be paid by the buyer.
In the event of an explicit request for work by OPTIKON technicians, all travelling and lodging
expenses shall be charged to the customer.
OPTIKON 2000 S.p.A. is not liable for damages caused during transport. If this occurs, the
customer must immediately notify the carrier that handled the delivery.
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3 WARNINGS
The following warnings will aid the user to provide adequate safeguards in order to
assure safe and trouble free performance of the HiScan echograph:
General warnings
• All medical personnel should read and understand the instructions in this manual
before using the device. Do not attempt to use the device if it fails to perform as
described in this manual.
• The use of this device is a matter of professional judgement in all cases. Optikon
2000 s.p.a. is not responsible for any clinical problem resulting from mishandling
this device and makes no medical recommendations.
• The alteration of the device without the manufacturer's authorization is
forbidden.
Environmental warnings
• Do not install the device near sources of heat or expose it to direct sunlight or
high temperatures.
• Do not obstruct the ventilation ports.
• The device must never be used in the presence of inflammable anaesthetics,
inflammable disinfectants or other substances which may cause fires or
explosions.
• The use of inflammable anaesthetics, (N2O), (O2), should be avoided unless
they are removed by a gas aspiration system.
• Do not dispose of the “HiScan” device as unsorted municipal waste. Dispose of
it separately according to local electrical and electronic equipment disposal
laws/regulations..
• The use of accessories or cables different from those provided with the device
could cause an increase in emissions or a decrease in the immunity of the
system. The emissions originating from portable equipment for
telecommunications could affect the device performance.
• Carefully follow the instructions for the installation and use of the device, so as
to prevent dangerous interferences with neighbouring equipment. If this device
causes dangerous interferences to other equipment (condition that can be
determined by turning the device on and off), the user is recommended to
attempt to correct this condition with one or more of the following methods:
• - Reposition the other units
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OPTIKON 2000
- Increase the distance between the units

- Connect the device to a power outlet that is different from the one to which the
other units are connected
- Contact the distributor or authorized OPTIKON 2000 Technical Support
Department
Electrical warnings
• To avoid the risk of electrical shocks, always connect the device to a power
supply with appropriate grounding.
• To avoid the risk of electrical shocks, do not remove the covers from the device
and its accessories. Verify that all maintenance and reparation operations are
carried out by qualified technical personnel.
• Connect the device to a power supply having the characteristics shown on the
rear panel of the device. For safety purposes, use hospital grade power cords
and plugs and ground the device.
• The additional equipotential connection through the cable must be used when it
is not possible to guarantee an appropriate grounding protection against indirect
contacts in all or part of the system.
• Before connecting the device to the power supply, or disconnecting it, verify that
the main switch is Off.
• When the echograph is not in use, the main switch should always be in off
position.
• Replace the fuses with the same type of fuses, as indicated on the rear panel of
the device or in this document.
• To immediately disconnect the device from the power supply in case of
emergency, it is sufficient to switch it off using the main switch on the rear of the
device.
Ordinary maintenance
• Do not sterilize the probes using hot air or by chemiclave.
• Do not use solvents or alcohol to clean the external surfaces of the device.
• The probes (and their boxes) are not supplied sterile and must be disinfected
before being applied to patients.
Biometry
• Gently apply the probe on the moistened cornea, being careful not to alter its
normal geometry.
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• In case of doubt on the size, perform a calibration test on the probe. If the test
fails or the probe is not working correctly, do not use the device and contact the
technical support.
Pachymetry
• Gently apply the probe on the moistened cornea, being careful not to alter its
normal geometry.
• In case of doubt on the size, perform a calibration test on the probe. If the test
fails or the probe is not working correctly, do not use the device and contact the
technical support.
Echography
• Gently apply the probe on the patient's eye using ultrasound gel or another
substance suitable to facilitate the penetration of the ultrasounds in the tissues.
• When using an immersion probe, use the special “mini-bath” cup with sclera
support.
• The immersion cup must always be filled with sterile solution.
• Keep the cup in place with one hand without applying an excessive pressure. If
liquid leaks from the sclera supporting ring, apply a thin layer of methocel to
enhance adherence.
• Remove the liquid from the cup using a syringe without needle.
• Clean and sterilise the probes before using them on another patient or applying
them to the other eye of the patient.
Footswitch
• Never lift or move footswitch by the cable to avoid possible damages.

• The footswitch is not autoclaveable.
• The pedal can be used to activate the following functions:
o Freeze/Unfreeze – Starts/stops Bscan, Biometry, Pachymetry or AScan

scans
o Save – Saves the current scan
o Rec – Starts/stops the recording of a movie
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4 SYMBOLS
The table below lists some I.E.C. approved symbols along with their meanings. If
space is insufficient, these symbols are often used on medical instruments to enable
quick and simple communication of information and warnings. At times two or more
symbols are combined together in order to highlight a specific hazard or instruction.
These are the symbols used on the HiScan label. Before using the device, familiarize
yourself with the symbols and definitions provided in the table.
SYMBOLS PUBLISHED BY EN
SYMBOL DESCRIPTION SYMBOL DESCRIPTION
OFF (DEVICE
DISCONNECTED FROM
ALTERNATING CURRENT
THE POWER SUPPLY)
ON
PROTECTIVE EARTH (DEVICE CONNECTED TO
THE POWER SUPPLY)
EQUIPOTENTIAL EARTH TYPE B APPLIED PART
MANUFACTURER AND
IMPORTANT! MANUFACTURING DATE
SEPARATED WASTE
REFER TO THE COLLECTION FOR
INSTRUCTIONS MANUAL ELECTRICAL/ELECTRONI
C EQUIPMENT
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5 GENERAL INFORMATION
The piezoelectric effect in natural crystals was observed for the first time by Pierre
and Jacques Curie in 1880, who proved that, when deformed due to mechanical
causes, some types of crystals (quartzes, tourmaline) produced an internal electric
field. Vice versa, the application of an electrical field caused the mechanical
deformation of the material. If appropriately treated with a polarisation process, some
ceramic materials are able to acquire the piezoelectric properties of natural crystals.
These materials that are obtained with an innovative technology are called
piezoelectric ceramics. Biometry probes have a piezoelectric ceramic component that
"vibrates" at a frequency of 10 megahertz (10 million oscillations per second) when
an electric pulse is applied. This movement of the ceramic transducer generates an
ultrasound wave with an ultra-low energy that passes through the cornea, aqueous
humour and other objects or tissues that are within the signal propagation path. Part
of the ultrasound wave passes through the obstacles, while part of it is reflected back
to the source (that is the transducer). The reflection of this energy back to the
transducer requires some time, which is proportional to the distance of the obstacle.
The measurement of this time and the experimental acquisition of the echo speed
enable to mathematically calculate the distance between the object (for example the
retina) and the emitter (probe tip). The characteristics of the return echo are then
processed by a fast micro-processor that verifies if they are reliable for measuring
purposes (automatic acquisition).
5.1 SYSTEM DESCRIPTION

Echograph A/Bscan HiScan - OPTIKON 2000 - is a device is designed to be used to
perform echographies of the eyeball, measure the axial length of the eye and
calculate the IOL that is more appropriate to restore emmetropy after cataract
removal. This device owes its uniqueness to its reliability, versatility, accuracy and
easiness of use combined with an appealing and functional design. Its main controls
can be managed using the footswitch, touch-screen, mouse or keyboard.
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Figure 5-1 – Description of the device components
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1: LED that indicates that the device is on; 2: probe support; 3: Bscan connector; 4:
biometry connector; 5: USB ports; 6: additional equipotential grounding terminal; 7:
serial port (RS-232); 8: video output; 9: fuse compartment; 10: main switch; 11:
power connector The main features of the echograph are the following:
• B-MODE
Images with ultra-high resolution

Axial resolution up to 35 microns and lateral resolution up to 50 microns in the
anterior segment (50 MHz probe).
It is possible to highlight minimum variations in the eyeball morphology (25 MHz
probe)
Ultra-wide scanning range

The whole anterior segment can be viewed with one scan without having to rebuild
the image via software
Kinetic B-Scan
It is possible to view the movement of ciliary muscles during the accommodation and
movement of the crystalline and accommodative intraocular lenses
High gain
Vitreal or corpuscle non homogeneity can be analysed
Two operating modes

Suitable for in depth diagnoses of the anterior segment, posterior segment, vitreous
and eye socket
Indicated for pre-/post-implant and pre-/post-Lasik measurements (ideal for the
implant of phakic lens)
Biometry in B-mode
Accurate biometry even in presence of pathologies like detached retina or
hypermature cataract
Large “database”
Options to store and display all patients' exams and to export images in JPG format
• BIOMETRY
Accuracy
Possibility of selecting different measurements for pseudo-phakic eyes and for
different implant materials
Safety
Automatic measurement acceptance criteria, depending on the type of eye examined
(normal, pseudo-phakic, etc.)
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Immersion measurements
Cup for accurate biometries in water bath
State-of-the-art formulas
Accurate calculations even for severely ametropic eyes or eyes treated with refractive
surgery
• PACHYMETRY
Accuracy
The 50MHz pachymetry is the up-to-date technique for ultrasound measurement of
the cornea thickness.
Safety
Automatic measurement acceptance criteria, with automatic indication of the
standard deviation for each measurement.
• DIAGNOSTIC A-SCAN
Measurements
Possibility of using the available biometric measurement functions with a non focused
AScan probe at 8 MHz
Diagnostics
Possibility of highlighting the internal reflectivity of injuries
5.2 TECHNICAL SPECIFICATIONS
PARAMETER SPECIFICATIONS
Manufacturer: OPTIKON 2000 S.p.A.
Via del Casale di Settebagni 13
00138 Rome - Italy
Model: A/BScan HiScan Echograph
Regulatory conformity: 93/42/EEC concerning medical devices
Technical standards: EN 60601-1 ; EN 60601-1-1 ;
EN 60601-1-2
ENVIRONMENTAL SPECIFICATIONS
Storage: temperature range: from –10°C to +70°C, Humidity 10-
100% (non condensing)
Operating: temperature range: from +10°C to +35°C, Humidity 30-
75%.
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ELECTRICAL SPECIFICATIONS
Input voltage: 100V~ - 240V~
Frequency: 50/60 Hz
Maximum load: 100VA
Fuses: T1.5AH
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PARAMETER SPECIFICATION
TECHNICAL SPECIFICATIONS
• B-MODE
Gain Variable, from 0 to 115 dB

TGC Software, from 0 to -30 dB
Signal dynamics on “frozen” image from 10 to 80 dB
Contact probes 12 MHz , 20 MHz
Immersion probe 50 MHz
Transducers for immersion probes 25 MHz, 35 MHz
Scanning angle for immersion probes 30°
Scanning angle for contact probes 60°
Image definition (not interpolated) 256 lines x 2048 pixels
Image definition (interpolated) 1024 lines x 2048 pixels
Field of view from 15 to 60 mm (1x zoom)
Grey levels 256
Echographies black and white, colour
Axial resolution (50 MHz probe) 35 microns
Lateral resolution (50 MHz probe) 50 microns
Database size 500 kByte / exam
Measurement capacity Distance 1 and distance 2
Angle, Area
Audible signal Yes
• BIOMETRY
Probe: piezoelectric with fixing light,

designed to be mounted on
tonometric slide
Frequency: approx. 10 MHz
Gain: adjustable
Depth of measurement: from 1 to 60 mm
Electric resolution: app. 40 microns
Operating modes: phakic, cataract, aphakic,
pseudophakic, manual
Type of lens: PMMA, acrylic, silicone, “user def.”
Speed: preset for each segment
or modified by user
Other settings: eye with silicone oil
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Measurements Average of 5 measurements

andstandard deviation
Measuring methods: automatic and manual
Calculation formulas: SRKII , Haigis, Holladay, Hoffer Q,
SRK/T, Post-refractive (Camellin-
Calossi)
• DEVICES AND CONNECTIVITY
HiScan is a PC-based standalone device with Windows operating system and

supports therefore all the devices that can be connected to state-of-the-art PCs, that
is printers, modems, video projectors, burners, video printers, backup units, local
networks, etc.
• ACOUSTIC EMISSION PARAMETERS ACCORDING TO STANDARD

EN/EN 61157
See pages 5-7
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B mode B mode B mode B mode

Unit of Transducer: Transducer: Transducer: Transducer:
Parameter
measurement 12 MHz probe, 20 MHz probe, 35 MHz probe, 50 MHz probe,
ref.143002/143200 ref.143003/143300 ref.143004/143600 ref.143005/143500
Maximum power [mW] 0.9 ± 0.2 0.5 ± 0.1 0.01 ± 0.003 0.01 ± 0.003
Negative peak
acoustic pressure [MPa] 3.137 ± 0.345 2.663 ± 0.274 1.896 ± 0.246 1.196 ± 0.155
[p - ]
Intensity of exit
[mW/cm²] 3.7 ± 0.8 2.0 ± 0.4 0.03 ± 0.01 0.03 ± 0.01
group [I OB ]
Average
temporal intensity
[mW/cm²] 254.2 ± 28 118 ± 24 22.3 ± 5.6 8.1 ± 2.0
of spatial peak
value [I SPTA ]
Focal length [l p ] [mm] 18.3 21.5 12.1 12.2
Width of pulse
group (6 dB,
[mm] 0.65 0.58 0.30 0.26
parallel)
[w pb6 ║]
Width of pulse
group (6 dB,
[mm] 0.67 0.69 0.28 0.26
orthogonal ) [w pb6
┴]
Frequency of
pulse repetition Hz 4729 4729 3598 3598
[prr]
Frequency of
scan repetition Hz 18.5 18.5 14.1 14.1
[srr]
Dimensions of
[mm] 3.5 3.35 3.45 3.42
exit group
[mm] 3.4 3.20 3.40 3.49
Average
frequency of
[MHz] 11.0 15.5 21 22
acoustic
application [f awf ]
Distance
between
transducer and [mm] 3.15 3.15 --- ---
transducer's exit
face [l tt ]
Separation
distance from [mm] Contact Contact 9 9
transducer [l ts ]
Fraction of
acoustic power-
up
Fraction of
acoustic 80 % 80 % 80% 80 %
initialization
Power-up
B B B B
method
Initialization
B B B B
method
Emission
Yes Yes Yes Yes
blockage
Modes included --- --- --- ---
Pulse length Pulse length Pulse length
Control Pulse length
133 ns 83 ns 50 ns
configuration Voltage 249V pp
Voltage 249V pp Voltage 249V pp Voltage 249V pp
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CLASSIFICATION OF THE DEVICE ACCORDING TO EN 60601-1
• Type of protection against electric shocks: class I

• Level of safety of the application in the presence of a mixture of
inflammable anaesthetics: not suitable
APPLIED PARTS
• Biometry output
Class of protection against electric shocks: B
• B-Scan output
Class of protection against electric shocks: B
DIMENSIONS OF THE DEVICE
Height: ............................................... 37 cm
Width: ................................................ 51 cm
Depth: ................................................ 19 cm
Weight: .............................................. 8 Kg
NOTES
1) The weight and dimensions indicated are approximate.
2) Specifications subject to variations without prior notice.
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5.3 ELECTROMAGNETIC COMPATIBILITY TABLES
5.3.1 GUIDANCE AND MANUFACTURER’S DECLARATION –

ELECTROMAGNETIC EMISSIONS
HiScan is intended to be used in the electromagnetic environment specified below.

The customer or user of HiScan should assure that it is used in such environment.
Electromagnetic Environment –
Emissions test Compliance
Guidance
RF emissions HiScan uses RF energy for its
internal functions only. Therefore, its
CISPR 11
Group 1 RF emissions are very low and are
not likely to cause any interference in
nearby electronic equipment.
RF emissions HiScan is suitable for use in all
Class B establishments including domestic
CISPR 11
establishments and those directly
Harmonic emissions connected to the public low voltage
Class A
EN 61000-3-2 supply network that supplies
buildings used for domestic
Voltage purposes.
fluctuations/Flicker
Complies
emissions
EN 61000-3-3
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5.3.2 GUIDANCE AND MANUFACTURER’S DECLARATION –

ELECTROMAGNETIC IMMUNITY
HiScan is intended to be used in the electromagnetic environment specified below.

The customer or user of HiScan should assure that it is used in such environment.
Immunity test EN 60601 test level Compliance level Electromagnetic Environment – Guidance
Electrostatic discharge • ±6 kV contact • ±6 kV contact Floors should be wood, concrete or ceramic tile.
(ESD) If floors are covered with synthetic material, the
• ±8 kV air • ±8 kV air
EN 61000-4-2 relative humidity should be at least 30%.
Electrical/fast • ±2 kV for power supply lines • ±2 kV for power supply lines Mains power quality should be that of a typical
transient/burst commercial or hospital environment
EN 61000-4-4 • ±1 kV for input/output lines • ±1 kV for input/output lines
Surge • ±1 kV differential mode • ±1 kV differential mode Mains power quality should be that of a typical
EN 61000-4-5 commercial or hospital environment
• ± 2kV common mode • ± 2kV common mode
Voltage dips, short • <5% U T (>95% dip in U T ) for • <5% U T (>95% dip in U T ) for Mains power quality should be that of a typical
interruptions, and 0.5 cycles 0.5 cycles commercial or hospital environment. If the user
voltage variations on of HiScan requires continued operation during
• 40% U T (60% dip in U T ) for 5 • 40% U T (60% dip in U T ) for 5
power supply input lines power mains interruptions, it is recommended
EN 61000-4-11 cycles cycles that the Keratron® Scout be powered from an
• 70% U T (30% dip in U T ) for • 70% U T (30% dip in U T ) for uninterruptible power supply or a battery.
25 cycles 25 cycles
• <5% U T (>95% dip in U T ) for • <5% U T (>95% dip in U T ) for
5 seconds 5 seconds
Power frequency (50/60 3 A/m Not applicable Power frequency magnetic fields should be at
Hz) magnetic field The device does not contain any level characteristic of a typical location in a
EN 61000-4-8 magnetically sensitive typical commercial or hospital environment.
components.
Portable and mobile RF communications
Conducted RF 3 Vrms 3 Vrms equipment should be used no closer to any part
EN 61000-4-6 of HiScan, including cables, than the
recommended separation distance calculated
From 150 kHz to 80 MHz from the equation applicable to the frequency of
the transmitter.
Recommended separation distance:
Radiated RF 3V/m d= 1.2 √P
EN 61000-4-3 3V/m d= 1.2 √P From 80MHz to 800 MHz
From 80 MHz to 2.5 GHz d= 2.3 √P From 800MHz to 2.5 GHz
Where P is the maximum output power rating to
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 surveya ,
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:
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NOTES
U T is the a.c. supply voltage prior to the application of the test level
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.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) 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 HiScan is used exceeds the applicable RF compliance level
above, the device should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating HiScan.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
5.3.3 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE

AND MOBILE RF COMMUNICATION EQUIPMENT AND HISCAN
HiScan is intended for use in an electromagnetic environment in which radiated RF

disturbances are controlled. The customer or the user of HiScan can help preventing
electromagnetic interference by maintaining a minimum distance between portable
and mobile RF communications equipment (transmitters) and HiScan as
recommended below, according to the maximum output power of the
communications equipment.
Separation distance according to frequency of transmitter

Rated maximum (m)
output power of From 150 kHz to 80 From 80 MHz to 800 From 800 MHz to 2.5
transmitter (W) MHz MHz GHz
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 12 23
For transmitters rates at maximum output power not listed above, the
recommended separation distance d in metres (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.
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5.4 CIRCUIT DIAGRAMS

On request, OPTIKON 2000 S.p.A. may supply circuit diagrams, list of components,
descriptions, calibration instructions or other information to assist the user's qualified
technical personnel to repair any part that can be repaired.
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6 INSTALLATION
6.1 INTRODUCTION
This section details the recommended procedure to install HiScan.
The operational checks, carried out after the installation of the device to verify its
correct operation, must be carried out exactly as indicated and must never be
considered as recommended practice or encouragement for any diagnostic
procedures.
In order to be able to use the echograph, it is first necessary to connect the cables,
footswitch and probes.
Carefully follow the installation and operation procedure in sequence to be able to
gain the knowledge required to correctly operate the echograph.
6.2 UNPACKING AND INITIAL INSPECTION

The device has been packed to minimise the risk of damage during shipping. Open
the package and examine the components. When opening the package, handle all
the components with care. When cutting the packing material, be careful not to
damage the contents. If the package or contents are damaged, notify the carrier
(post office, railway or shipping agent) and Optikon 2000 as soon as possible. Check
that the contents correspond to those indicated in the attached shipping documents.
Immediately report any discrepancies to Optikon 2000.
Depending on the selected configuration, the package of the A/Bscan HiScan

echograph contains the following standard and optional components:
• 1 echograph
• 1 contact probe, 10 MHz
• 1 contact probe, 20 MHz
• 1 immersion probe, 25 MHz
• 1 immersion probe, 50 MHz
• 1 probe, 12 MHz
• 1 probe, 20 MHz
• 1 probe, 50 MHz (Full configuration only)
• 1 transducer, 25 MHz (Full configuration only)
• 1 transducer, 35 MHz (Full configuration only)
• 1 probe cable
• 1 user manual
• 1 kit of cups for immersion ecography (available in the following sizes: "small",
"medium" and "large")
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• 1 biometry probe, 10 MHz

• 1 diagnostic A-Scan probe, 8 MHz
• 1 Pachymetry probe at 50MHz
• 1 test cylinder for biometry probe
• 1 printer
• 1 supporting trolley with insulation transformer and set of sockets
• 1 “Freeze-Save-Rec” footswtich for echograph
All the mechanical and electrical parts of this device have been carefully inspected
prior to shipping. Before unpacking the device, verify that the packing and its content
are undamaged. If visible transport damages are present, notify them to the carrier,
reseller or the sales office of OPTIKON 2000 in order to request the immediate
reparation or replacement of the device or its components.
6.3 INSTALLATION PROCEDURE
NOTE
The operator is directly responsible for cleaning and disinfecting all reusable probes and accessories..
To install the device, proceed as described below.
Installation and power-up:
1. Place the device on an horizontal surface and in a comfortable position for the
operator.
2. Insert the connector in the footswitch on the rear panel of the device.
3. Connect the device to the power supply using the power cord supplied.
4. Connect the Bscan cable to the front panel of the device.
5. Connect the Bscan probe (10 MHz, 20 MHz, 25 MHz, 35 MHz or 50 MHz) to
the cable
and place the probe in its support.
6. Move the main switch on the rear of the device and the main switch on the
insulation transformer, if available; to position ON.
7. The device powers-up automatically.
8. After the device has powered up and the probe has been inserted, verify that
the probe is correctly detected. Otherwise, select the probe manually
(following the instructions provided in the corresponding paragraph).
9. During pauses, leave the probe in its support and select the "Freeze” mode.
This maximises the life time of the probes that do not require any type of
maintenance.
10. It is generally advisable to switch the echograph off if you are not planning to
use it for long periods of time.
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Figure 6-1 – Connections on the device
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6.4 AUDIBLE SIGNALS
The device issues an audible sign ("beep") when:
• The initial test is in progress

• The probes are automatically detected
• A BSCAN image is stored in the database
• A video is stored in the database
• A biometry or pachymetry is acquired
• A set of biometric measurements is saved or a pachymetry map.
• When the measurements set is completed (pachymetry map or biometry), a
special audible signal is issued.
The audible signal is issued by the internal speaker of the device.
6.5 HOW TO CONNECT A VIDEOPRINTER
To connect a traditional videoprinter to the echograph, it is sufficient to use a

commercial VGA-Composite adapter with BCN adapter.
It is also possible to connect any type of Inkjet or laser printer using the USB port.
It is also possible to use a videoprinter with USB interface.
In this case, the available printing modes will be those of an ordinary printer.
When using a videoprinter, it is not possible to print multiple images as with ordinary
printers.
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6.6 LEAKAGE CURRENTS IN PRESENCE OF SINGLE

POINTS OF FAILURE
The device is fitted with an internal hospital grade power supply and leakage currents
are therefore within the limits indicated in standard EN 60601-1.
Attention: if the device is connected to non-hospital grade devices like

projectors, external storage units or other equipment fitted with power supply,
the leakage currents could exceed the limit value foreseen for electromedical
devices in the event of single point of failure.
In this case, it is advisable to connect an insulation transformer to the HiScan device

and to the devices to which it is connected during the installation phase.
Attention: if an insulation transformer is used, HiScan should not be connected

to a modem or LAN, because leakage currents in case of single point of failure
could exceeed the limit value defined in standards concerning electromedical
devices. The only connections that can be used are those able to guaranteee a
suitable insulation (for example WI-FI, Bluetooth).
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6.7 UPDATING THE DEVICE SOFTWARE
HiScan is supplied ready for use. The software is directly installed by the
manufacturer.
The device is however supplied with a CR-ROM that includes the complete release
of the software and can be used for maintenance or to reinstall the HW updates.
The CD-ROM contains in particular the board drivers and the HiScan software. The
installation instructions of the software are usually printed directly on the CD-ROM.
In all cases the installation procedure is the following:
• Remove previous versions of the HiScan software, if existing (uninstall the
software by following the appropriate procedure in the control panel of
Windows XP or Windows 7 – Add programs).
• During startup the new hardware will be automatically detected and the
operator will be prompted for the applicable drivers: insert the installation CD
in the reader, and select the folder "XPInstall" which contains the required
drivers. Wait until the hardware installation procedure automatically finishes.
• Only at this point, it is possible to install the HiScan software by launching the
program Setup.exe in the installation CD-Rom's main folder (for example,
“D:\setup” if D is the letter designating the CD-Rom drive being used).
• The software installs automatically. It is therefore sufficient so follow the
prompts and confirm. During the software installation, if the device will be used
by several users, you will prompted to select between a "multi-user" or "single-
user" installation. In the first case the HiScan software will be available to all
the users who logon to the device; in the second case it will be available only
to users who enter the "User ID" and the "Password," if any, that were set
during installation.
• Restart HiScan. The program will be launched automatically at the end of the
start-up procedure.
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To view the version of HiScan installed in the echograph, select “Help” + “About
Optikon …..” as shown in the figure.
Fig. 6.2 – Displaying the HiScan version
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7 USING THE DEVICE
7.1 USER INTERFACE
7.1.1 MAIN MENU
After the start-up operations have been completed, the device displays an interface
similar to the one shown in the following figure.
Figure 7-1
The UI of the echograph consists of a "Main" window (see Figure 7-1) that gives
access to the main features of the device.
These features are:
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• BSCAN BScan echography

• BIOMETRY Biometric measurements and IOL calculation
• DIAGNOSTIC ASCAN AScan measurements
• PACHYMETRY Measurements of the cornea thickness (inactive)
To switch between the different functions, it is necessary to return to the "Main"

window.
Windows cannot be resized and are displayed at full screen.
7.1.2 BSCAN
Press button BSCAN on the touchscreen to use the BScan function. The window
show in Figure 7.2 displays.
Figure 7-2
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No further operation is required to use this function, because the device is able to
automatically detect the probes. If the device fails to detect the probe, it is necessary
to select it manually using the dropdown menu:
Select menu "File", option "Choose Probe" and the type of probe used (see Figure 7-
3).
Figure 7-3 – Selection of the B-Scan probe
The BScan UI consists of a "Main" window (see Figure 7-2) with a dropdown menu,
status bar and a series of buttons that can be selected from the touschreen or with
the mouse. This window displays:
• The image window (type A, B or AScan on BScan echographic image)
• Indicator with patient name, the eye being examined (right or left), the date
and time
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• The buttons of the main operating modes and functions

• The Zoom”, “Delay” and “Image size” options
• The tree containing the patients' demographic data in alphabetical order
• The “tabbed controls” with the patients' demographic data, exam data and
biometry, if available
7.1.2.1 DROPDOWN MENU
The dropdown menu is always available and can be activated in the following modes:
BScan, Biometry, AScan and Pachimetry (optional).
The layout of the dropdown menu is shown in the following figure:
Figure 7-4 – Dropdown menu
The following sections illustrate all the menu items.

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“File”
The options of menu “File” are the following:
New Patient – Opens the window in which it is possible to insert the demographic
data of a new patient in the patients' database.
Patients Manager – Opens the window in which it is possible to manage the records
(i.e. edit, delete, etc.) the records in the patients' database.
Operator– Opens the window in which it is possible to enter the operator's name.
Chose Probe – Opens a submenu from which it is possible to select the type of
probe (12.5 MHz, 20 MHz or 35/50 MHz).
Probe Settings – Opens a property sheet that can be used to manage the operating
parameters of the probes and save them on a drive (this option cannot be used by
users).
Save – Saves a complete exam (data + ecographic image) in the patients' database.
Print Preview – Displays a preview of the exam.
Export– Exports the image in a standard PC format.
Print – Prints a complete exam.
Print Selected Images– Allows to the operator to print on a single A4 printout page
up to 6 Bscan images (previously selected) with customized header and diagnosis
(see also <Actions>+<Printout Header>).
“Freeze (Unfreeze)”
Menu “Freeze (Unfreeze)” can be used to activate/deactivate the ultrasound scan of

an echographic probe.
“Mode”
The options of menu “Mode” are the following:

Enhanced – Activates the high resolution mode on the frozen image.
TGC On – Activates the “Time Gain Compensation” on the Bscan Images.
Vertical – Activates the vertical (or orizzontal) viewing of the Bscan Image.
Bilinear Filter On – (Only for frozen Bscan images) activates a smoothing filter on
the image.
Biometry Filter – Open a submenu for the selection of the filtering mode applied to
biometry data.
“Actions”
The options of the “Actions” submenu are the following:

Reset– Loads the factory default parameters.
OS / OD – Displays the window in which it is possible to select the eye (left or right)
to examine.
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Show bang (Hide bang) – Activates/deactivates the display of the ultrasound probe
"bang". The "bang" is always displayed in mode A.
Colors (Gray scale) – Activates/deactivates the display of fake colours in the echo
image in mode B. In other modes, images are always displayed in greyscale.
Biometry Settings – Allows to the operator the modification of the biometry
parameters.
Show Gradient Bar – Visualize the chromatic scale of the Bscan Images.
Select Color’s Gradient – Selection of the chromatic scale.
Show TGC Curve– Visualize the TGC curve.
Select TGC Curve – Selection of a TGC curve and creation of a customized one.
Run 3D Reconstructor – Run the 3D Reconstructor program (see para. 11-Software
for 3D imaging).
Printout Header – Creation of a customized printout header (Only for multiple image
printout – see para. 8.3.2).
“Help”
The “Help” menu can be used to display the About window of the application.
Figure 7-5 – “About” window
The following data are visualized in this window:

• Software version
• Model of the equipment
• Firmware version
“Save”
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As the “Save” button of the footswitch, it allows to the operator to memorize the
actual test in the database.
7.1.3 BIOMETRY
Press button BIOMETRY to access the Biometry function and display the window
shown in Figure 7.6.
Figure 7-6 – Biometry window
In this case, it is necessary to select the biometry probe connected to the device by
using the appropriate connector on the lateral supporting block.
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All the biometry functions (calculation of intraocular lenses, measurements, etc.) can
be selected from the following modules:
• Biometry data
• Biometry Settings
• IOL Calculation
• Keratometric Constants
• IOL Database
“Biometry Data” module
This module displays all data related to biometry (Anterior Chamber, Lens, Axial
Lenght) and enables users to select the type of exam (Phakic, ...). This module can
be used to control the progress of the biometric exam.
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Figure 7-7 - “Biometry Data” module
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“Biometry settings” module
This module displays the "tabbed page" of the routine settings used to calculate
biometry. The module can also be used to recall, edit and save the data related to
the sound propagation speed through the materials of the intraocular lens and in the
eye, and the sampling and noise thresholds.
Figure 7-8- “Biometry settings” module
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“IOL Calculation” module
It is possible to display this module in Biometry mode by simply touching button

"IOL".
This module can be used to display the form used to calculate the intraocular lenses
using the measured biometry parameters (axial length), the data stored in the lens
database, the keratometric constants and the formulas available in the module.
By means of this window it is possible to select two different Intra Ocular Lens (IOL)
and one of the available calculation formulas. The selected lens and formula are
stored automatically and will be immediately available for the following IOL
calculation, also after the switch-off and switch-on of the equipment.
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Figure 7-9- “IOL Calculation” Module
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“Keratometric constants”module
This module can be used to display the box where it is possible to determine the K
and R keratometric constants used to calculate intraocular constants.
Figura 7-10- “Keratometric constants” module
“IOL Database" module

This module can be used to display the form that enables to manage the complete
IOL database.
Figure 7-11- “IOL Database” module
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7.1.4 DIAGNOSTIC ASCAN
Press button AScan diagnostic on the touchscreen to access the Diagnostic Ascan
function and the window shown in Figure 7.12.
Figure 7-12 – Ascan diagnostic window
In this case, it is necessary to select the connected diagnostic Ascan by means of

the appropriate connector on the lateral supporting block. The connector is the
same as the biometry probe. The correct probe must be selected each time by the
operator.
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7.1.5 PACHYMETRY
7.1.5.1 WARNING
Apply the probe gently to the patient’s cornea using the minimum pressure necessary
to keep the tip in contact. The probe tip must be perpendicular to the cornea surface.
The measurement must follows immediately the first contact to the cornea, otherwise
repeat all from the beginning.
7.1.5.2 USER INTERFACE
Figure 7.13: Pachymetry environment
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If the unit is correctly working (the small circle bottom right of the screen is green),
the operator can carry out the following functions:
• Button <DB> : access the patient and tests database.

• Field <OD>: select the eye to link with the test (--, OD, OS).
• Button <Main>: return to main screen.
• Button <Unfreeze> (toggle Freeze): start or stop acquisition.
• Button <Clear>: clear the current screen to start a new test.
• Button <Settings>: access the pachymetry environment settings window.
• Button <Print>: print the acquired pachymetry map.
• Button <Calibration>: calibrate the instrument. See paragraph 7.1.5.5.
• Button <Manual> (toggle Auto): calculate measurements in automatic or
manual mode.
• Button <Image>: allows to go back to the pachymetry main window from
the map selection window.
• Button <Gain>: modify the gain
• Button <Maps>: access the map menu from which the operator can select
one of 10 pre-defined maps and 8 customized by the user.
Figure 7.14: Map selection menu
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By clicking the left button of the mouse (or touching the touchscreen) on one of
the maps between Map1 to Map10 or User1 to User8, the operator can select that
map for the operation. In order to go to the main pachymetry window, just click on
the <Image> button or on the small window with the preview of the selected map.
In the same time the selected map will be available for future acquisitions, also
after the shutdown and switch on of the equipment.
• Button <Modify>: It appear when a customizable map is selected (from User1

to User8). Pushing the “Modify” button the selected map is visualized on the
main window and the operator can add or remove one or more acquisition
points. Just touch an existing point to remove it or touch the specific point to
add a new one. After the modification, in order to save the modified map it is
necessary to push the specific <Save> button (it appear under the “Modify”
button after the first map modification).
7.1.5.3 HOW TO OPERATE THE DEVICE IN A PACHYMETRY

ENVIRONMENT
By activating the instrument using the Freeze/Unfreeze button or the foot-pedal, the
operator can display the signal from the pachymetry probe on bottom right of the
screen.
Figure 7.15: Pachymetry environment and command

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The relevant point of the eye on which the operator needs to carry out the
pachymetry scan is highlighted on the map. When the value has been acquired, the
next point is automatically displayed, and continues in this way until the map is finally
completed.
When the instrument is in automatic mode, acquisition stops as soon as the peaks
are considered a technically valid pachymetry scan. After a few seconds, acquisition
starts again for the next point on the map, and continues in this way until the map is
completed.
When the test is completed, the map will display coloured circles inside which the
measured corneal thickness is shown. The background colour reflects the standard
deviation value for each measurement:
Green: σ < 5
Yellow: 5 ≤ σ < 10
Red: σ ≥10
The background colour assumed by the measured point depends on the standard
deviation value, but for diagnostic purposes has no significance.
Every pachymetry measurement carried out displays the corneal thickness measured
(Thickness) and the standard deviation (Std.dev.).
When the map is completely filled, if the operator wants to repeat the measurement
on some points, follow the intructions:
• Double click with the rigth button of the mouse on that point
• The point become grey and flickering
• Touch again the cornea with the tip of the probe in the same indicated point
• The measurement will be acquired automaticly
• Repeat the procedure for each point with wrong measurement
• Save the map.
On saved map isn’t possible to repeat the measurements but each measure can be
changed manually. In order to change the value, foolow the istructions:
• Select the point on the map
• Click on the small window with the echoes (Bottom/Rigth of the screen)
• The echoes window will be exchanded with the main map window.
• Move the cursor on the desired points
• Store the value pushing the <Store> button in order to change the value on
the map
• Repeat for all the desired points on the map
• Save the map by pusching the <Save> button on the footswitch
At the end of the test, the value of the central corneal thickness (CCT) is displayed in
two of the boxes next to the map, and also of the delta pressure to be used as a
corrective factor in Goldman tonometry (∆IOP).
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By selecting one of the points on the map, the operator can subsequently display the
signal that produced the measurement.
When working in manual mode, the operations are more or less the same except that
the signal peaks are not intercepted automatically.
The operator needs to:
• press the foot-pedal (or the Freeze/Unfreeze button) to stop the acquisition
• Adjust the marker on the desired peacks
• Push the <Store> button in order to put the value on the map
• Automatically the system go to the next point
• Repeat the procedure for all the points on the map
• Save the map by pusching the <Save> button on the footswitch.
In this mode, standard deviation is not calculated, so the little circles on the map will
all be green.
At the end of the test, the operator can select the various points on the map, open
the editing window and position the markers to change the measurements.
7.1.5.4 SETTINGS OF THE PARAMETERS
In the pachymetry environment settings window, the operator can alter some
parameters that determine the measurements.
In order to open the setting windows, push on the <Setting> button.
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Figure 7.16: Pachymetry environment settings window
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From the Settings window it’s possible to change the follows pachymetry parameters:
• “Corneal velocity”: Ultrasound corneal velocity
• “Avg Corneal Thickness” : Parameter utilized in the Delta IOP correction
formulae
• “K-Constant” : Parameter utilized in the Delta IOP correction
formulae
• “Safety Value” : Percentage of the measured value, to be
used for the microkeratome setting.
• “Threshold Level” : Measurement threshold. Decrease the
threshold in case of very thick cornea.
• “Unfreeze on Start” : Starting condition (Freezed or Unfreezed)
In order to reset the parameters values to the predefined one, push the button
<Reset value>
Push the <Apply> button if you want to confirm the changes.
Push the <Cancel> button if you want to abort the changes.
Push the <OK> button in order to close the current window.
It is strongly recommended to avoid any changes of the parameters if you are not
absolutely certain of the new values. Wrong parameters mean wrong
measurements.
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7.1.5.5 CALIBRATING THE PACHYMETER
The first time the operator accesses the pachymetry environment, he or she is asked
to calibrate the instrument.
Figure 7.17: How to calibrate the pachymetry
This is done by placing the pachymetry probe in a glass of water, vertically and not
touching the bottom, as shown in the above diagram, and confirming on the monitor
that he or she wants to continue with the test (or push the <Calibrate> button in
order to start with the calibration procedure).
If calibration ends successfully, a confirmation message, as shown below, will be
displayed,
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Figure 7: Pachymetry calibration done
Otherwise, a calibration failed message will be displayed.
Should this occur, try shaking the probe in water to remove any micro-bubbles from
its sensitive surface and repeat the calibration procedure pressing <Calibrate>
button. If the problem persists, contact the Optikon 2000 service department.
The operator is strongly advised to calibrate the instrument every time the
pachymetry probe is changed, and in any event, at regular intervals, in order to
guarantee the proper functioning of the pachymeter.
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8 OPERATION
8.1 SELF-TEST SESSION

HiScan features a self-test function that enables operators to continuously control that
the echograph is working correctly.
The device is controlled at regular intervals of 5 seconds. If the test is successful, a
green mark appears on the display (see Fig.8-1). If the test fails a red indicator
displays.
In this case, it is necessary to switch HiScan off and check the cable connections.
Switch the device back on and wait for the indicator to switch from red to green
(approximately 5 seconds). If this does not occur, there is a serious fault and the
echograph must be returned to the technical support.
The device also continuously controls the presence of the BScan probe. If the test is
successful, its frequency is shown on the display (see Figure 8-1).
If the test fails, it is necessary to inspect the probe or connection cable and replace
them if required.
Figure 8-1 – Self-test and probe inspection
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8.2 BIOMETRY PROBE TEST

It is possible to run a test in order to check the operation of the probe and the
accuracy of the biometric measurement. This can be done using the small clear
cylinder in plastic (code 149001) showing the test measurement value in millimetres
and the tolerance (+/-0.1 mm.).
NOTE: the cylinder material (Plexiglas) is subject to thermal dilatation like all
materials. Therefore, the value indicated on the cylinder refers to an ambient
temperature ranging from 20 °C to 25 °C.
For values below 20°C, subtract 0.1 mm from the rated value indicated on the label.
For values above 25 ℃, add 0.1 mm fr
EXAMPLE: IF THE VALUE INDICATED ON THE LABEL IS 20.8 MM AND AMBIENT TEMPERATURE IS ABOVE 25 °C, THE
REFERENCE VALUE IS 20.9 MM. CONSIDERING A TOLERANCE OF +/- 0.1 MM, THE DEVICE SHOULD REPORT
20.9+0. 1=21.OMM AND 20.9-0.1=20.8 MM.
In all cases, the cylinder temperature should not exceed 30°C because otherwise the
signal attenuation would not allow any automatic acquisition. For this reason, it is
advisable to place the cylinder on a surface without touching it or, alternatively, to hold
it only for the time strictly necessary to complete the measurement.
The recommended procedure is the following:
• Open the Biometry session.

• Select mode "Aphakic".
• Apply a drop of ultrasound gel on the surface of the probe and distribute it
consistently on the cylinder.
• Perform five measurements in automatic or manual mode.
If the alignment is correct, the echo will have the maximum amplitude and the
measurement will be acquired automatically. If the echo amplitude is insufficient to
"automatically freeze" the image, try increasing the GAIN.
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8.3 FEATURES
The following sections describe in detail the procedures that have to be followed to
activate the functions described above along with the sub-menu windows that display
when these features are activated.
These features are generally available in all operating modes (Bscan, Biometry,
Diagnostic Ascan). Some specific features are however available in some operating
modes only, as specified below.
Information is provided for the following features:
Funzione Tasto
• Operator – Enables the operator's name to be entered
• Print – Print of the current test
• Reset - Reset to the default parameters
• Keyboard – Open a virtual keyboard on the screen
• Record – Record of a movie (the movie is automatically

saved at the end of the acquisition.
• 3D – Reconstruction of a 3D image from a specific movie
• Play – Play of a recorded movie
• Zoom – zoom of images (only Bscan)
• Gain – Modify the amplification applied to the

echographic signal.
• Delay – Move the image along the time axis.
• Image size – Modify the size of the image
• Scan Rate – Modify the frame rate of the image
• Pulse – Duration of the stimulus applied to the transducer
• Velocity – setting of the ultrasound velocity
• DB – Patients and tests database management
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• Image – Measurements and Ascan on BScan

(only BScan)
• Filters – Enables the filters on the Bscan images
8.3.1 OPERATOR
This option can be used to enter the operator's name.

The operator's name is always linked to the exam. Selections are stored in the device
memory. Therefore, the device will continue to display the same name, even after a
power off, until a new operator's name is selected.
To enter an operator's name, press button “Operator” (see Fig. 7.1) or select
"Operator" from the “File” menu.
This is the screen that displays the box where the operator's name can be entered.
Press "OK" to complete the operation.
If no operator's name is specified, the test is linked to the default "Unknown" operator's
name.
Figure 8-2 – Selection of an operator
8.3.2 PRINT
Prints the current image.
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Touch button “Print” or select “Print” from the dropdown menu (see Fig. 7.4) to print
the current Bscan image, the biometry, the pachymetry or the Ascan image,
depending on the selected operating mode (see fig. 8.3a).
Figura 8-3a – Printout
In Bscan mode, operators can use a more advanced print function that enables to print
up to six images with text in A4 format along with the heading. All the information
contained in this form can be edited by the operator (see fig. 8.3b).
In order to have a printout similar to the one showed in fig, 8.3b the operator can do
the following items:
• Define an header for the printout. This item ca be performed during the
equipment installation and the defined header will be available for all the
printout, also after the reboot of the equipment. In order to modify the
printout header it is necessary to select “Printout header” from the menu
“Actions”. See the fig. 8.5 for aprintout header sample.
• Select the images for the printout. With the rigth button of the mouse or a
long touch, by means of the touchscreen, on the images, mark it with
“Select for printing”. It is possible to mark at maximum six images.
• From the menu “File” select the function “Print Selected Images” in order
to start the printout procedure. After that, a specific window for the
inputting of the text with diagnosis will be showed. The operator can input
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the diagnosis, “Import” and modify an existing text, save a diagnosis and
proceed to the print.
Figure 8-3b – Multiple images printout
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Figure 8-4 – Inputting of a diagnosis
Figure 8-5 – Printout header modification
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8.3.3 RESET
Resets the settings.

By pressing “Reset” operators can reload all the default settings of the currently
selected probe and cancel all the zoom, gain, delay pulse length and other settings
modified by the operator.
8.3.4 KEYBOARD
Displays the virtual keyboard on the screen.

By pressing button “Keyboard” operators can display a virtual keyboard on the screen
in order to enter text (patient name, operator's name, comments, parameters, etc.).
The keyboard continues to be displayed until it is closed by pressing the appropriate
button (white X with red background), as shown in figure. 8-6.
Figure 8-6 - Virtual keyboard
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8.3.5 RECORD
Records a movie.
By touching button “Rec”, operators can start recording a movie (this can also be done
using the footswitch).
The maximum recording length is fixed and generally equivalent to 20 seconds.
Operators may however cancel the recording at any time by touching button “Rec”.
It is however possible to change the maximum recording length by changing the
device settings. Operators may set any length ranging from 1 second to hundreds of
seconds. It is important to remember that every second of recording produces
approximately 3-4 Mbyte..
The movie is automatically stored in the database under folder "Movie" and linked to
the patient being examined.
8.3.6 PLAY
Plays a recorded movie.

By touching button "Play”, operators can start playing the currently selected movie. If
no movie has been selected, the device opens the "Movie" folder so that the operator
can manually choose the movie to play.
8.3.7 3D
Rebuilds a 3D ecographic image.

For further information, see Appendix that provides detailed information on the 3D
reconstruction of ecohgraphic images.
8.3.8 ZOOM
Enlarges echographic images (Bscan only).

The "zoom" function, which is available in Bscan mode only, can be used to enlarge
specific areas of an echographic image.
The selection of high zoom levels could cause "artifacts" in the image due to the fact
that the resolution remains unaltered. This problem can be corrected in two ways:
• By applying one of the two available filters (see function "Filters" described
below). This option does not improve the resolution, but makes the image more
aesthetically appealing.
• By increasing, when possible, the resolution by changing the sampling
frequency. For information on how to change the sampling frequency, see
section "Image size".
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8.3.9 GAIN
Controls the amplification of the echographic signal.

It is possible to change the saturation level of the image or the height of the
echographic peaks by modifying the setting of "Gain". For BScan ecographic images,
it is generally advisable to set a high "gain" or amplification gain in order to be able to
view vitreal fogging and reduce the level to be able to measure the thickness (cysts,
melanomas, muscles, interfaces, etc.).
8.3.10 DELAY
If used along with "Zoom" and "Image Size", option "Delay enables to select the image
section to display.
8.3.11 IMAGE SIZE
Dimensions in mm of the image window.

This option enables operators to select the image sampling rate and to consequently
obtain a scannning depth of 63 mm, 31 mm and 15 mm both in BScan mode (with a 1
mm) and Biometry and Ascan mode.
A high full scale enables to obtain full views of the eyeball including the orbit (63 mm).
An intermediate value (31 mm) enables to obtain a detailed view of the eyeball. A
lower value (15 mm) is instead ideal to obtain an optimum view of the details (ciliary
muscles, retina, etc.).
If a low value is used, it is essential to use the delay function to display the desired
detail. Always pay attention to the probe focus that must be on the displayed detail.
Probes have a fixed focus. Therefore, the focus area can be changed only by
approaching or distancing the probe head from the cornea.
8.3.12 SCAN RATE
Number of complete scans per second performed by the probe.
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8.3.13 PULSE
Length of the stimulation pulse generated by the echographic transducer. It is possible

to set any value ranging from approximately 20 nsec to 133 nsec. The optimum pulse
length depends on the frequency of the transducer in the ecographic probe. Generally,
the smaller the length of the puls and the greater the resolution. However, in this case
the penetration depth of the echographic signal is smaller.
8.3.14 VELOCITY
Velocity of the ultrasounds. This value is only used to calculate the distances on
images in the BScan and AScan modes. A standard ultrasound velocity is instead
used to rebuilt images.
Attention: the operator is responsible for selecting each time the velocity that best suits
the tissue being measured.
The velocity is not used to calculate biometric values, because in this case the device
uses the default velocities set for the tissues. Operators may however change the
default values from the dropdown menu (refer to the applicable paragraph) and using
option Settings, which is available in Biometry mode also.
8.3.15 IMAGE
Measurements and activation of the Ascan vector on BScan (BScan only).

Button “Image” can be used to activate a set of actions that can be performed on the
image, depending on the selected operating mode. In BScan mode, it can be used to
activate the "calipers" to measure the distance, angle and area. In this mode, the
button can also be used to activate an additional zoom (unlimited) option and enter
notes in the images.
It is also possible to display an AScan vector on a BScan image.
In Biometry mode, this button can be used to open the tables with the biometric
measurements that have been acquired automatically or, if the appropriate button is
pressed, to view those acquired manually by means of the footswitch.
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8.3.16 FILTERS
Activates the filters on the echographic image (Bscan only).

This option enables operators to activate two types of image filters.
Depending on circumstances, it is possible to activate:
• An interpolation filter that multiplies the number of lines that make the image
from 256 actual lines to 1024 interpolated lines.
• A bi-linear filter that dampens the sudden gaps between two adjacent pixels.
This option basically "smoothens" the image.
It is possible to apply both filters simultaneously.
Their effectiveness is particularly visible with high zoom levels.
8.3.17 SEARCH FUNCTION
Button "Set Filter" enables to set a search filter.

This function enables to configure a set of search parameters based on a classification
of the images that must be chosen by the operator.
Operators can in fact use button “Details” to classify each image as shown in Fig. 8-7.
Button “Set Filter” can be used to display the window shown in Fig. 8-7 where
operators can enter the desired search parameters.
For example, if "Iris" and "Melanoma" are selected and the search is run, the device
displays a list of all the images or movies that have been previously classified as "iris
melanomas".
At this point, operators can use the touchscreen or mouse to display one of the exams
in the list.
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Figure 8-7 –Image classification data - Search parameters
8.3.18 DB (DATABASE)
This function can be used to manage the database that contains information on exams
and patients.
Patients and exams database
The Patients database comprises the following modules:

• “New Patient” module
• Patient” module
• “Test” module
“New Patient” module
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Select “New Patient” from the main menu to access this module.
In this module operators can display the form in which it is possible to enter or edit the
demographic data of patients in database Patients. This form displays additional
features, although its layout is similar to the one where existing data can be edited.
Figure 8-8- “New Patient” module
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Patient” module
This module can be used to display the data of the selected patient in the
demographic data tree.
“Test” module
This module can be used to display the data of the selected exam in the demographic
data tree.
Figura 8-9- “Patient” and “Test” modules
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8.4 USING THE DEVICE

After start-up, the device can be used without configuring specific settings.
ATTENTION
• The use of some programs (like antivirus programs running
continuously) with HiScan may influence the performance of the device
(significantly reducing for example the scanning rate).
8.4.1. GENERAL INSTRUCTIONS
1) Select the desired operating mode from the main menu (Bscan, Biometry,
etc.).
2) Select the operator's name by selecting Operator on the display.
3) Select the operator's name.
a. If the patient already exists, use the tree in the right pane of the
screen.
i. Left click symbol (+) in the left pane of the tree.
ii. Click the patient's name to select the patient as current one.
iii. Click (+) on the left of the name, then click (+) on the left of
the date to display the list of images.
iv. Click an image number to select it (BSCAN displays).
b. If the patient is new, select New Patient. The corresponding window
displays.
i. Enter the surname, name and any other desired data, then
touch SAVE and use the mouse cursor to move to the
subsequent fields. Press SAVE or Cancel.
ii. Current Database displays in the pane.
iii. A new patient can be saved only after the name an
surname have been entered.
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8.4.2. HOW TO USE B-SCAN
1) The BSCAN function can be activated by selecting BScan from the main
menu or by simply using button Freeze/Unfreeze (or the footswitch).
2) Move selector GAIN up or down to adjust the image gain (it is generally
recommendable to increase the GAIN to view the vitreous).
3) Move selector Image PULSE up or down to adjust the pulse length. The
selection of low pulse length increases the resolution but reduces the exam
depth ad the brightness of images. Diversely, the section of higher pulse
lengths increases the visual range and brightness of images, but can
sometimes reduce the resolution. The last operating mode (longest pulse
length) can be useful if silicone oil is present in the eye or if the vitreous is
being tested.
4) Move selector Image Size up or down to select the image scale (do not
change it in ordinary operating conditions because the computer
automatically selects the best scale for each probe).
5) Move selectors ZOOM and Delay up or down to adjust the zoom and
longitudinal position of the image.
6) If no patient name is selected, the patient is configured as "Anonymous".
Otherwise, it is possible to select an patient name from the left tree or add a
new patient. When a new patient is added, this automatically set as Current
patient.
7) Select the eye to examine by pressing F6 or OS/OD/--.
8) Press button SAVE (on the panel or footswtich) to save the current image in
the current patient folder.
9) After the scanning is stopped (by means of the “Freeze” button on the
screen or footswitch), the inputting of a short comment will be requested.
Furthermore, on the main screen appears a cursor that allows to the
operator the selection of the best frame, starting from the current untill the
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previous 16 frames.That function is very usefull in order to visualize very

small and hard to find lesions. After the selection of the best frame, the
operator can store it in the database by means of the “Save” button. (see
fig. 7.2).
10) To perform measurements on the acquired image or saved images, use
the buttons on the left of the BSCAN screen.
a. To perform distance measurements, click with the left button of the
mouse icons (d1) or (d2), then right-click the measurement start point,
select the end point while keeping the mouse button pressed and
finally release the button.
b. To perform angular measurements, click with the left button of the
mouse icon (α), click the vertex of the angle to measure, keep the
button pressed, position the cursor on the first segment, release the
button, click it once more and move to the next segment.
c. To measure an area, click with the left button of the mouse icon (A),
click the right button of the mouse and follow the perimeter of the
surface to measure. Release the mouse button to complete the
measurement.
d. To enlarge an image, click with the left button of the mouse icon (+),
click the right button of the mouse and highlight the image to enlarge.
e. To delete previous measurements, click with the left button of the
mouse icon (X).
11) Press buttons “Filters” + “Colorize” + “Colors” to change an image from
black and white to a different colour or vice versa. By means of the button
“Select Gradient” it is possible to select a specific color palette.
12) To print the image, press Print and verify that the printer is connected
to the PC. It is also possible to print a full size A4 page with: Header, from
one to six images and a diagnosis. (see para. 8.3.2)
13) If the BSCAN mode is active, press REC on the BSCAN screen to start
recording a movie.
14) The recording automatically ends after approximately 20 seconds and the
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movie is saved in the database. It is also possible to end the recording by

pressing once more <enter> on the front panel of the device. The file is
saved in a standard AVI format and can therefore be displayed in Windows
(Windows 2000, Windows XP, Vista, Windows 7 or Windows 8).
15) To recall a specific movie, it is sufficient to click the green triangle in the
BSCAN screen.
8.4.3. HOW TO USE THE ASCAN FUNCTION IN BSCAN MODE
This function improves the identification of tissues and is useful to analyse reflectivity.
1) To perform an ASCAN on a BSCAN image, it is sufficient to press

“Image”+”A/Bscan”+”Active/Canc ASCAN”
2) Click with the left button of the mouse the line at the centre of the screen and,
keep the button pressed and move the cursor to explore the BSCAN image.
The A-Scan image on the BSCAN screen moves along with the mouse.
3) Using a specific Bscan technique (e.g. Immersion) it is possible to image the full
eye, from cornea to macula. Apply the ASCAN on BSCAN on that image and
select the vector from the cornea to the macula. By means of the button
“Biometry on Bscan” it is possible to do the biometric measurement of the eye
and the related IOL calculation.
8.4.4. HOW TO USE THE BIOMETRY FUNCTION
1) Press the Biometry button to allow the device to automatically select the
biometry probe.
2) Select “Unfreeze” or press the spacebar. A shifting red line displays.
3) Use the GAIN up/down arrow keys to adjust the gain.
4) Select the manual or automatic mode.
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5) Select the type of eye (aphakic, phakic, pseudo-phakic, with cataract).

6) Select Immersion to use an immersion cup.
7) Select Silicone Oil if the eye is filled with silicone oil.
8) Perform the measurement of the eye. If you select Auto, the acquisition of
values automatically ends after each measurement has been completed. The
acquisition of values automatically restarts after a preset period of time, which is
generally around 3 seconds, so that the next measurement can be performed.
In manual mode, the acquisition of values must be started and stopped
manually. At the end of the process (up to ten measurements), it is important to
remember to save all the patient data by pressing <save> on the footswitch.
The data is permanently stored in the database.
9) Press the button “Setting” to display the panel in which it is possible to set the
ultrasound rate inside the eye and other constants.
a. Corneal is the US rate inside the cornea.
b. Aqueous is the US rate inside the aqueous humor.
c. Vitreous is the US rate inside the vitreous humor.
d. Lens is the US rate inside the natural crystalline lens.
e. Average is an average value used for internal calculations.
f. PMMA is the US rate for a pseudo-phakic eye with PMMA intraocular
lens (for the lens selection only).
g. Acrylic is the US rate for a pseudo-phakic eye with acrylic intraocular
h. Silicone is the US rate for a pseudo-phakic eye with silicone intraocular
i. Silicone Oil is the US rate in the silicone oil.
j. User defined is an additional setting that can be used for new lens (if
present).
k. Marker can be used to move the white line along the screen and
represents the automatic freezing/unfreezing threshold for biometry
echographs (a choice of a value between 150 to 230 is strongly
recommended).
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l. (a1) and (a2) are constant values used to calculate the Haigis IOL.
10) The button IOL can be used to display the pane in which it is possible to
select the intraocular lens.
a. The measured axial length (AXL) and anterior chamber (ACD), if
present, are automatically copied in the boxes.
b. Add the keratometric value (K). Click the box on the right of“Average K”
to enter the K1 and K2 or R1 and R2 values. The device automatically
calculates the average value (when values R1 and R2 are entered, the
device also calculates values K1 and K2).
c. Select the IOL from the database (Lens Style). The lens data is
automatically entered in the corresponding boxes (A, SF and ACD
constant values).
d. The IOL database is initially empty and must therefore be populated with
the lens data.
1) Click “Edit IOLs” to open the pane in which it is possible to add
the characteristics of a new lens. Before entering the data of a
new lens, click area <Action> with the green triangle. After
entering the data of a new lens, click Save in area <Action> (the
box with the floppy disk symbol). To delete a lens, click the box
with the red rectangle in area <Action>. The first button in area
<Action> can be used to search for a lens.
e. Select a IOL calculation formula. The device performs the calculation
automatically.
f. Click “Print Lens” in the IOL pane to print the data of the IOL to implant
(the printer must be connected to the PC).
g. It is also possible to simultaneously calculate a second lens that will be
printed in the same page (see fig. 8.10).
h. The selected formula and IOL’s will be available as the defaults for the
following calculation, also after the switch off and switch on of the
equipment.
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Figure 8.10- Biometry printout
8.4.5 USING THE FOOTSWITCH
The footswitch has three buttons, “FREEZE”, “SAVE” and “MOVIE”, that can be used
to activate the following features:
• FREEZE/UNFREEZE: press button “FREEZE” for a few seconds to start

scanning the probe or stop it if it is in progress.
• SAVE: press this button for a few seconds to save the displayed image. The
image is saved even if the probe is running a scan.
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• MOVIE REC : press this button to start recording a movie. The recording
ends after the preset interval of time or whenever the footswitch is pressed.
8.5 SHUTDOWN PROCEDURE
NOTE
Follow the procedure described below to shut the device down for long periods of time.
1. Use the "shutdown" procedure in the operating system to shut the device down.
2. Then, move the main switch to position "OFF". Verify that all the LEDs are off.
3. For further information, refer to chapter "Cleaning, sterilization and

maintenance".
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THIS PAGE HAS BEEN INTENTIONALLY LEFT BLANK.
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9 CLEANING, STERILIZATION AND MAINTENANCE
Medical personnel is responsible for keeping all the instrumentation and equipment in
the best operating conditions. The simple steps described below constitute a
practical guideline for defining a suitable care and maintenance program.
9.1 CLEANING
9.1.1 DEVICE
1) Regularly clean the LCD screen with a soft cloth dampened with distilled water. If
necessary, use a neutral detergent only.
2) Do not use alcohol, solvents or abrasives to clean the device.
9.1.2 ACCESSORIES
For information on how to clean the accessories, please refer to the indications given
in the relevant instructions for use.
9.2 STERILIZATION
9.2.1 DEVICE
The device and footswitch cannot be sterilized.
9.2.2 ACCESSORIES
For information on how to sterilize the accessories, please refer to the indications
given in the relevant instructions for use.
9.3 REDUCING THE RISK OF INFECTIONS

To reduce the risk of infections, specifically after using the probes on patients at risk,
it is advisable to thoroughly follow the cleaning, disinfection and sterilization
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instructions provided with the accessories. A disposable protective cap should

always be used in presence of UBM.
9.4 MAINTENANCE
9.4.1 DEVICE
Store the echograph in a clean dry location at room temperature.
NOTE
To keep the device safe, check the device's conformity with electric current leakage limits according to
standard EN60601-1 at least once a year. Contact the bioengineering division of your facility or your
Optikon 2000 authorised distributor/service centre.
9.4.2 ACCESSORIES
1) Avoid dropping or mishandling probes and accessories. It is critical that these

components be handled with outmost care and inspected thoroughly after each
use for any damage or wear.
2) Place the probes on the support after each use. Avoid placing the probes on a
table: a potential fall could damage the tip and make it unusable.
3) Cover the probes with the protective caps if you are not planning to use them for
long periods of time.
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10 TROUBLESHOOTING GUIDE
PROBLEM CORRETIVE ACTION

THE DEVICE DOES NOT SWITCH ON. Inspect the power cords.
Move the rear switch to position ON.
THE OPERATING SYSTEM DOES NOT START The hard disk is damaged or the start-up
(THE WINDOWS SCREEN DOES NOT files are corrupt. Reinstall the operating
DISPLAY) system.
"WINDOWS" STARTS NORMALLY BUT THE Manually run program:

ECHOGRAPH SCREEN DOES NOT DISPLAY
C:\HiScan\BSCANSDI.EXE
If the problem is solved, perform an
automatic reboot from program
BSCANSDI.EXE (start-up menu).
WHEN PERFORMING A MANUAL BOOT, Verify that the drivers have been
PROGRAM BSCANSDI.EXE DOES NOT correctly installed: a copy of the
START AND AN ERROR MESSAGE DISPLAYS drivers is available on the CD-ROM
supplied with the echograph.
THE ECHOGRAPH SCREEN DISPLAYS BUT See paragraph 8.1.

THE LOWER RIGHT CORNER CONTINUES TO
DISPLAY IN RED (FAILED SELF-TEST) AND
THE DEVICE DOES NOT START
THE SELF-TEST ENDS SUCCESSFULLY (THE Try replacing the problem (damaged
LOWER RIGHT CORNER OF THE SCREEN probe).
DISPLAYS IN GREEN) BUT THE DEVICE IS
Replace the probe cable (damaged
NOT ABLE TO DETECT THE INSERTED
probe cable).
PROBE
The device is not working correctly
(contact the technical support).
THE SELF-TEST IS SUCCESSFUL, THE Try replacing the problem (damaged

PROBE IS DETECTED, BUT THE DEVICE probe).
DOES NOT RUN (REMAINS IN FROZEN
Replace the probe cable.
MODE) EVEN WHEN THE MENU IN THE
UPPER LEFT SECTION OF THE DISPLAY IS Contact the technical support.
USED
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HiScan Toch Installation and Operation Manual
OPTIKON 2000
PROBLEM CORRETIVE ACTION

THE SELF-TEST IS SUCCESSFUL, THE Try replacing the problem (damaged
PROBE IS DETECTED AND THE DEVICE probe).
STARTS (A TYPICAL MECHANICAL NOISE
Replace the probe cable.
CAN BE PERCEIVED WHEN APPROACHING
THE PROBE TO THE EAR), BUT NO IMAGE Contact the technical support.
DISPLAYS
THE IMAGE DISPLAYS BUT THERE IS A LOT Move the echograph to another location
OF BACKGROUND NOISE (if there are strong electromagnetic
emissions or noise in the mains, the
quality of images may be degraded).
Use a mains filter and an hospital-grade
insulation transformer (to significantly
attenuate conducted emissions).
Contact the technical support.
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OPTIKON 2000
11 APPENDIX 1 - 3D IMAGING SOFTWARE
Figure 11-1
11.1 INTRODUCTION
The 3D imaging software has now been integrated in the HiScan software.
This software enables to acquire 3D VTK images and is fully compatible with most
commercial 3D software applications.
3D reconstructions are created using as input an AVI movie that is constituted by
parallel section of the object being rebuilt.
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Figure 11-2 - 3D image of a coroidal melanoma
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11.2 DESCRIPTION OF THE 3D SOFTWARE
The main 3D window is illustrated in Figure 11-2.
Figure 11-3 -Main window of a 3D reconstruction
The following controls are available on the menu bar:

• File
• Edit
• Registration
• View
• Help
All the buttons displayed in the window depend on the selected language and on the
language of the operating system.
From menu "File" operators can activate the following functions:
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Figure 11-4 –"File" menu
"Open”: enables operators to open an existing *.VTK 3D image.

This window can be used to select the file to open.
Figure 11-5 - Window “Open”
The selected 3D image is opened in a new window, as shown in the following figure:
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Figure11-6- Loaded 3D image
It is possible to use the mouse to rotate the image around the three axes or enlarge it
by following this procedure:
• Click the left button of the mouse, place the cursor along the edge of the
image and rotate it in the same direction.
• Right-click the upper section of the image to enlarge it.
• Right-click the lower section of the image to reduce it.
It is possible to display small 3D windows and enlarge the images up to the size of
the windows even when using PCs with low performances (the greater the
performances and the faster is the image rendering). If the 3D window takes up the
whole screen and a high zoom level has been selected, the PC may display a
warning to inform the user that the memory is insufficient (in which case it is
necessary to increase the available RAM).
It is also possible to use menu "Open" to open an *.AVI file e convert it to a 3D

image. If the software is run from the main HiScan software, it is not necessary to
open the movie because this operation is performed automatically. If an AVI file has
been opened, it is automatically displayed as shown in the following figure.
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Figure 11-7 – Frame selection form
The green arrow keys can be used to play a movie, to scroll the movie by frames or
to go to the first or last frame. The current frame is displayed in the corresponding
field. An Undo button is also available.
The "Equipment settings" and "Image settings", used during the recording of the
movie, are also displayed in the window (type of probe, scanning angle, gain, zoom,
delay and size of the image in millimetres).
To create a 3D image, select the first frame (Start), the last frame (Stop) and the area
that has to be rebuilt (the red window in the movie).
If the settings have already been configured, click "3D" to start rebuilding the 3D
image.
If the rebuilt image is not displayed in the 3D window, the display parameters are
incorrect. In this case, it is necessary to save the image as "name.VTK" and reopen
the saved file. The display parameters will be reset and the image displays.
The last red button on the right can be used to close the window.
To obtain an optimum 3D image in the simplest way possible, use a single scan (from
left to right or from top to bottom) when recording the movie.
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In this case, it is not necessary to select the first and last frame (that is the first and
last frame of the movie) because these are set automatically. It is in fact sufficient to
drag the red window on the image that has to be rebuilt.
"Save As”: saves the 3D image as *.VTK file.
Figure 11-8 – Window “Save As”
Enter the name of the 3D image to save and click "Save".

The layout of the window changes according to the selected language and the
messages displayed vary according to the operating system installed.
In the example, the Italian version of Windows XP has been installed on the PC.
"Exit” can be used to close the program and return to the operating system or the
main HiScan program (depending on the 3D software settings).
From menu "Edit" operators can select the following submenu:
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OPTIKON 2000
Figure 11-9 – Menu "Edit”
Option "Rendering Parameters” can be used to change the parameters for the 3D
rendering.
The available parameters are the following:
Figure 11-10 – Window “Rendering Parameters”
"Sampling Distances”: these are the distances between the sections on axis X, Y or
Z.
The value of these parameters is dependant on the scan time of the object being
rebuilt.
For optimum results, the values of axes X and Y should correspond to the default
settings. The value of axis Z depends on the lateral speed of the probe during the 3D
scan, which is determined by the motor (for motor-driven scans).
The following figure shows the linear scan to use.
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OPTIKON 2000
Figure 11-11 – Scan results
It is possible to use the axis Z adjustment function to correct the deformation of the
3D image (the length of the image is increased when the value of axis Z is increased
or reduced).
"Noise Threshold” represents the transparency level: if the value is increased, the 3D
image only contains the most widespread points (for example to display the mobile
bodies of the vitreous, it is necessary to decrease the value down to 10-15).
To confirm the changes, click OK. If no parameter has been changed, click Cancel.
From menu "Registration" operators perform a special transformation of the 3D

image
Fig. 11-12 Menu “Registration”

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OPTIKON 2000
This transformation should be performed for "experimental purposes only" and is

recommended to avoid changing the original image.
The available transformations are "Translation” and "Affine”: the first option compares
adjacent frames in order to reduce the "noise" resulting from the probe translation
during a 3D scan, while the second one compares some points on the 3D image in
order to prevent the deformation of the image due to the movement during a 3D
scan.
Menu "View" is inactive and will be made available in future software upgrades.
Menu "Help" enables operators to view information on the release and manufacturer
of the software.
Figure 11-13 – Menu “Help”
Figure 11-14- Window “About”
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OPTIKON 2000
11.3 HOW TO USE THE 3D RECONSTRUCTOR
Follow these steps to create a 3D image:
• Create a movie with a single scan.
Figure 11-15
• Select the movie in the HiScan database.
Figure 11-16
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OPTIKON 2000
• Start 3D Reconstructor.
Figure 11-17
• Drag (with the mouse cursor) the red window on the section of the image that
has to be rebuilt and click button 3D.
Figure 11-18
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OPTIKON 2000
11.4 TROUBLESHOOTING AND CORRECTING IMAGE

ADJUSTMENT DEFECTS
The following figures illustrate some problems that may occur when acquiring 3D
images along with the recommended corrective actions.
Figure 11-19- Result of a multiple scan of the anterior eye segment
If the probe is moved from one side to the other of the eye (from left to right, from
right to left and again from left to right), the resulting 3D image is similar to the one
shown in the previous figure.
To correct this problem, it is possible to select only the four frames of a single scan
and use the first and last frame, as shown in the following figure.
Figure 11-20
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OPTIKON 2000
Figure 11-21 - 3D image with incorrect axis Z parameter
If an incorrect parameter of axis Z is used, the 3D image is elongated.

To correct it, it is necessary to adjust the rendering of axis Z as shown in the figure
above.
The value is dependant on the scan rate of the probe.
Figure 11-22
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OPTIKON 2000
Figure 11-23- 3D image with an excessively high noise threshold
The image is too dark. To correct it, it is necessary to reduce the noise threshold. The
recommended value is 30 (or a lower one).
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Cod 14101XEN

OPTIKON 2000 S.p.A.

All OPTIKON 2000 products are manufactured in compliance with the

OPTIKON 2000 S.p.A.

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2 LIMITED WARRANTY CONDITIONS

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- Increase the distance between the units

• Never lift or move footswitch by the cable to avoid possible damages.

o Freeze/Unfreeze – Starts/stops Bscan, Biometry, Pachymetry or AScan

o Save – Saves the current scan

o Rec – Starts/stops the recording of a movie

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SYMBOL DESCRIPTION SYMBOL DESCRIPTION

EQUIPOTENTIAL EARTH TYPE B APPLIED PART

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5.1 SYSTEM DESCRIPTION

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Figure 5-1 – Description of the device components

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Images with ultra-high resolution

Ultra-wide scanning range

Two operating modes

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5.2 TECHNICAL SPECIFICATIONS

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Gain Variable, from 0 to 115 dB

Probe: piezoelectric with fixing light,

Other settings: eye with silicone oil

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Measurements Average of 5 measurements

• DEVICES AND CONNECTIVITY

HiScan is a PC-based standalone device with Windows operating system and

• ACOUSTIC EMISSION PARAMETERS ACCORDING TO STANDARD

See pages 5-7

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B mode B mode B mode B mode

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CLASSIFICATION OF THE DEVICE ACCORDING TO EN 60601-1

• Type of protection against electric shocks: class I

DIMENSIONS OF THE DEVICE

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5.3 ELECTROMAGNETIC COMPATIBILITY TABLES

5.3.1 GUIDANCE AND MANUFACTURER’S DECLARATION –

HiScan is intended to be used in the electromagnetic environment specified below.

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5.3.2 GUIDANCE AND MANUFACTURER’S DECLARATION –

HiScan is intended to be used in the electromagnetic environment specified below.

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5.3.3 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE