OPTIKON HiScan User manual

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. [phone] - Fax. [phone]
E-mail [e-mail] - www.optikon.com

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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
1DISCLAIMER................................................................................. 1-1
2LIMITED WARRANTY CONDITIONS............................................ 2-1
3WARNINGS ................................................................................... 3-1
4SYMBOLS ..................................................................................... 4-1
5GENERAL 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
6INSTALLATION............................................................................. 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
7USING 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
8OPERATION.................................................................................. 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
9CLEANING, 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
Code 14101XEN 1-1 2014-09-02 Rev.B
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. [phone]
Fax. [phone]
E-mail [e-mail]
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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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

HiScan Touch Installation and Operation Manual
OPTIKON 2000
Code 14101XEN 3-2 2014-09-02 Rev.B
- 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.

HiScan Touch Installation and Operation Manual
OPTIKON 2000
Code 14101XEN 3-3 2014-09-02 Rev.B
•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:
oFreeze/Unfreeze – Starts/stops Bscan, Biometry, Pachymetry or AScan
scans
oSave – Saves the current scan
oRec – Starts/stops the recording of a movie

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OPTIKON 2000
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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
ALTERNATING CURRENT
OFF (DEVICE
DISCONNECTED FROM
THE POWER SUPPLY)
PROTECTIVE EARTH
ON
(DEVICE CONNECTED TO
THE POWER SUPPLY)
EQUIPOTENTIAL EARTH TYPE B APPLIED PART
IMPORTANT!
MANUFACTURER AND
MANUFACTURING DATE
REFER TO THE
INSTRUCTIONS MANUAL
SEPARATED WASTE
COLLECTION FOR
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.

HiScan Touch Installation and Operation Manual
OPTIKON 2000
Code 14101XEN 5-2 2014-09-02 Rev.B
Figure 5-1 – Description of the device components

HiScan Touch Installation and Operation Manual
OPTIKON 2000
Code 14101XEN 5-3 2014-09-02 Rev.B
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.)

HiScan Touch Installation and Operation Manual
OPTIKON 2000
Code 14101XEN 5-4 2014-09-02 Rev.B
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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Code 14101XEN 5-5 2014-09-02 Rev.B
ELECTRICAL SPECIFICATIONS
Input voltage: 100V~ - 240V~
Frequency: 50/60 Hz
Maximum load: 100VA
Fuses: T1.5AH

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Code 14101XEN 5-6 2014-09-02 Rev.B
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