Cod.390889 Rev.

OPTIKON 2000 S.p.A.

®
HiScan
Ultrasound Imaging
A/B_SCAN

USER AND INSTALLATION MANUAL

Pagina 1
TABLE OF CONTENTS
Page

1. DISCLAIMER.............................................................................................4

2. LIMITED WARRANTY...............................................................................4

3. WARNINGS ...............................................................................................6

4. GENERAL INFORMATION .......................................................................8

4.1. INTRODUCTION .......................................................................................8

4.2. COMPANY PROFILE ................................................................................8

4.3. WORKING WITH YOU ..............................................................................8

4.4. Q.C./TESTING ...........................................................................................9

4.5. HOW TO ORDER ......................................................................................9

4.6. DESIGN AND SPECIFICATIONS .............................................................9

4.7. THEORY OF OPERATION......................................................................10

5. SYSTEM DESCRIPTION.........................................................................11

5.1. B-MODE ..................................................................................................11

5.2. BIOMETRY ..............................................................................................11

5.3. TECHNICAL CHARACTERISTICS .........................................................12

5.3.1. Technical specification .......................................................................12
5.3.1.1. B-MODE.......................................................................................12
5.3.1.2. BIOMETRY ..................................................................................12
5.3.1.3. ELECTRICAL AND MECHANICAL REQUIREMENTS ................13

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6. INSTALLATION AND USE......................................................................14

6.1. PACKING ................................................................................................14

6.2. INSTALLATION.......................................................................................14

6.3. SHUTDOWN OF THE SYSTEM ..............................................................15

6.4. USE OF THE BSCAN..............................................................................16

6.4.1. COMMANDS ON THE FRONTAL PANEL.........................................17
6.4.2. GRAPHIC USER INTERFACE ..........................................................18
6.4.2.1. Introduction ..................................................................................18
6.4.2.2. Main Menu ...................................................................................20
6.4.2.3. “File”sub-menuu ...........................................................................20
6.4.2.4. “Freeze (Unfreeze)” sub-menuu...................................................21
6.4.2.5. “Mode” sub-menu.........................................................................21
6.4.2.6. Sub-menu “Options”.....................................................................21
6.4.2.7. “Help” sub-menu ..........................................................................22
6.4.2.8. Main function description .............................................................22
6.4.2.8.1.How to select the operator ........................................................22
6.4.2.8.2.Biometry....................................................................................23
6.4.2.8.3.Database Patients end examinations........................................28
6.4.3. How to use the HISCAN.....................................................................30
6.4.3.1. General function...........................................................................30
6.4.3.2. How to use the B-SCAN...............................................................31
6.4.3.3. How to use the ASCAN on BSCAN..............................................33
6.4.3.4. How to use the BIOMETRY .........................................................33

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 1. DISCLAIMER
The OPTIKON 2000 S.p.A. manufactures surgical and diagnostical devices for ophthalmology.
Our international reputation for product quality and performance is well established. We feel we
have the additional obligation to provide product information and WARNINGS to customers to
assist them in utilizing our products in a reasonable and safe manner.
The user of OPTIKON 2000 A/B SCAN Hiscan system is cautioned to review specific warnings
found in this manual. In no event shall OPTIKON 2000 S.p.A. be liable or responsible to user for
any injury, and incidental or consequential damages. It is incumbent upon user to provide its
personnel with a thorough understanding of the instrument operation before use. OPTI KON
2000 S.p.A. reserves the right to revise this manual without notice, for any reason. This includes
but is not Iimited to, utilization of advance in the state of the art and changes thereof. Liability for
difficulties arising from unknown or unforeseen technical limitation is disclaimed.

OPTIKON 2000 S.p.A.

Via del Casale di Settebagni, 13
00138 - Roma (ITALY)
Teleph. + 39 6 8888355 or + 39 6 8888366
Fax. + 39 6 8888388

NOTICE:
INFORMATION CONTAINED IN THIS MANUAL IS PROPRIETARY WITH OPTIKON 2000
S.p.A. REPRODUCTION OF ANY PART OR WHOLE MAY ONLY BE PERFORMED WITH
WRITTEN PERMISSION FROM OPTIKON 2000 S.p.A.

2. LIMITED WARRANTY
OPTIKON 2000 S.p.A. warrants the A/Bscan HiScan system to be free from defective parts and
workmanship for a period of one (1) year from the date of first purchase for use. Liability under
this warranty is expressly Iimited to repair or replacement of defective products at the option of
OPTIKON 2000.

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This warranty does not cover the results of misuse, accident or abuse of any parts of ‘OPTI KON
2000 A/Bscan HiScan system which have been repaired, tampered with, or altered by anyone
other than personnel authorized by OPTIKON 2000 S.p.A.

Products returned to OPTIKON 2000 S.p.A. for repair or replacement shall be received prepaid.

If found not to be defective under the terms of warranty a charge wiII be made for repair or
replacement and freight costs wiII be at customer’s expense.

Specifications subject to change without notice, prices subject to change without notice.

OPTIKON 2000 S.p.A. declares to be liable for safety, reliability and performances only if:

• upgrades

• calibrations

• repairs

are carried out by OPTI KON 2000 authorized personnel and if:
the mains electric installation to which the OPTIKON 2000 A/BScan is connected complies to the
UL Safety Regulations.

IMPORTANT NOTICE:
PRODUCT ENHANCEMENT RESULTING FROM OUR CONTINUING
QUALITY IMPROVEMENT EFFORT MAY NECESSITATE CHANGES
IN SPECIFICATIONS WITHOUT NOTICE.

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3. WARNINGS

Care in the handling of OPTIKON 2000 A/BSCAN HISCAN system is one of the first principles
and no amount of warnings can take place of such care.

NOTE: THIS INFORMATION IS BELIEVED TO BE CURRENT AT THE

TIME OF PUBLICATION, BUT IS PROVIDED WITHOUT WARRANTY OF
ANY KIND AND WE ASSUME NO RESPONSIBILITY WITH RESPECT
THERETO.

The following warnings wiII aid the user to provide adequate safeguards to assure safe,
troublefree performance:

1) ALL MEDICAL PERSONNEL SHOULD READ AND UNDERSTAND THE INSTRUCTIONS IN

THIS MANUAL PRIOR TO THE SYSTEM IS USED. DO NOT ATTEMPT TO USE THE SYSTEM
IF IT FAILS TO PERFORM AS SET OUT IN THE OPERATION PROCEDURES, IN THIS
MANUAL.

2) USE OF THE SYSTEM SHOULD BE RESTRICTED TO QUALIFIED MEDICAL PERSONNEL

3) USE OF THIS SYSTEM IS A MATTER OF PROFESSIONAL MEDICAL JUDGMENT IN ALL

CASES. OPTIKON 2000 S.p.A. IS NOT RESPONSIBLE FOR ANY CLINICAL PROBLEM
RESULTING FROM MISHANDLING THIS INSTRUMENT AND MAKES NO MEDICAL
RECOMMENDATIONS.

4) THE SYSTEM SHOULD NEVER BE USED IN THE PRESENCE OF FLAMMABLE

ANAESTHETICS, DISINFECTING AGENTS, CLEANING AGENTS, ETC., DUE TO POSSIBLE
FIRES OR EXPLOSION.

5) TO REDUCE THE RISK OF ELECTRIC SHOCK, DO NOT REMOVE COVER (OR BACK).
REFER SERVICING TO QUALIFIED SERVICE PERSONNEL

6) THE “OPTIKON 2000 A/BSCAN HISCAN CONTROL CONSOLE SHOULD BE CONNECTED

TO A MAINS SUPPLY ONLY AS MARKED.

7) FOR OPERATING SAFETY DO NOT INSTALL THE SYSTEM IN A LOCATION WHERE IT

WILL BE EXPOSED TO HEATING EQUIPMENT OR RADIATORS. DIRECT SUNLIGHT, AND
ANY OTHER SOURCE OF EXTREMELY HIGH TEMPERATURES.

8) DO NOT INSTALL THE “OPTIKON 2000 A/BSCAN HISCAN SYSTEM IN SUCH A WAY
THAT THE VENTILATING OPENINGS ARE BLOCKED.

9) BE SURE THAT THE POWER SWITCH ON THE CONTROL CONSOLE IS OFF WHEN
PLUGGING IN, OR REMOVING THE AC POWER ADAPTER FROM A WALL OUTLET.

10) TURN 0FF THE MAIN POWER SWITCH WHENEVER THE “OPTIKON 2000 A/BSCAN IS
NOT IN USE.

11) NEVER LIFT OR MOVE FOOTSWITCH BY THE CABLE. DAMAGE MAY RESULT.

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12) DO NOT ATTEMPT TO SEPARATE THE HANDPIECE OR PLUG FROM THE CABLE.

13) DO NOT SUBJECT THE HANDPIECE TO HOT AIR STERILIZATION, CHEMCLAVE OR

AUTOCLAVE.

Pagina 7
4. GENERAL INFORMATION

OPTIKON 2000 S.p.A. electro-medical product line has earned an international reputation for
being technically sophisticated, while remaining highly reliable and easy-to-use. Our ‘Research
and Development’ department prides itself on being able to produce innovative products to meet
demanding needs of the hospitals, clinics, and surgeons.

One of the factors that enables OPTIKON 2000 to produce such reliable products Is our
manufacturing and quality assurance programs. OPTIKON 2000 precision products are
meticulously manufactured in our own facilities by highly skilled technicians. We utilize special
production processes that optimize the reliability of our equipment.

And we undertake life cycle testing of every piece of OPTIKON 2000 equipment prior to shipping.
The result is equipment that is rarely returned for repair, and which we back with a
comprehensive one-year warranty.

This installation and operating manual is designed to give all needed information and instructions
required for successful operation of your ‘OPTIKON 2000 A/BSCAN HISCAN’ system.

Please read through these Installation and Operating Instructions carefully and then you
wiII know how to operate your “OPTIKON 2000 A/BSCAN HISCAN” system properly. After
you have finished reading this instruction manual, put it away in a safe pIace for future
reference.

A handy indexing system at the beginning of this manual gives you quick and direct
access to desired paragraphs.

Included in the Iast pages of this manual are engineering illustrations and other reference
information useful to the user of a ‘OPTIKON 2000 A/BSCAN HISCAN” system.

Optikon 2000 S.p.A. is proud to continue the work that OPTIKON OFTALMOLOGIA began in
1966 by putting themselves at the forefront of innovation, in the ophthalmic surgery and
diagnostic instrumentation field. We are recognized by the most demanding hospitals, clinics and
surgeons as being a cut above the rest of the industry.

This kind of widespread acceptance didn’t just happen. lt’s the result of nearly three decades of
inventive engineering, manufacturing expertise, uncompromising quality control procedures and
dedicated management.

Today, OPTIKON pioneering research has produced state-of-the-art products that address
almost every conceivable application of ocular surgery and diagnostics.

We constantly strive to maintain our position as the market leader in ocular surgery and allied
systems. Understanding our customer’s ophthalmic needs Is important, however more important
is our ability and commitment to convert that understanding to practical results.

OPTIKON 2000 S.p.A. is geared for customer support. We strive to develop a dose working
relationship with our customers and if we cannot meet your requirements with a standard

Pagina 8
product, we wiII be pleased to develop a customized design specifically suited to your
application. Whether your needs are straightforward or complex, we wiII find the appropriate
solution for your application.

OPTIKON 2000 maintains a fully approved instrument test department capable of testing to all
electrical, and mechanical requirements. Life cycle testing of production devices is conducted on
a continuing basis, monitoring overall quality of the end product. Each equipment is fully tested
and burned-in to ensure that It meets or exceeds all performance requirements.

Every OPTIKON 2000 product is available through a worldwide network of authorized

distributors. Whether you have a technical question, desire a product demonstration, or require
after sales service, every distributor has been trained to serve your needs.

At OPTIKON, our international department is staffed with personnel fluent in several Ianguages
to assist you. Please, contact us for the name and address of the OPTIKON distributor in your
area.

Due to improvements in design and/or specifications, some products may differ slightly from the
instruction manual representation/description.

IMPORTANT

THE SYSTEM IS MANUFACTURED TO SATISFY THE STRINGENT

REQUIREMENTS OF ‘GOOD MANUFACTURING PRACTICE’ (GMP) BOTH IN CONTROL
SYSTEM DESIGN AND ALL COMPONENTS OF BASIC PACKAGE AND ACCESSORIES.

The OPTIKON 2000 A/BSCAN HISCAN is optimally safeguarded and built according to the
Iatest INTERNATIONAL SECURITY STANDARDS as defined by IEC 601-1 and UL 544.

Pagina 9
The phenomena of piezoelectric effect of natural crystals was first observed by PIERRE and
JACQES CURIE in the 1880s. They showed that when certain types of crystals (quartz,
tormaline) are deformed by mechanical stress, they produce electric charge. This is commonly
referred to as the “GENERATOR EFFECT”. Conversely, when an electric field is applied to the
crystal it undergoes to a mechanical deformation. This is commonly referred to as the “MOTOR
EFFECT”. The concentrated research and material development led to the present highly
effective polarized piezoelectric ceramic materials. The piezoelectric ceramics differ from the
natural crystals in that they must undergo a poling procedure for the piezoelectric phenomenon
to occur. Their piezoelectric properties can be controlled as they result from the formulation and
the manufacturing process.
The A/BSCAN HISCAN probes contain a piezoelectric ceramic designed to resonate at the
frequency from 12.5 MHz to 50 MHz. An instantaneous electric field is applied to the ceramic
that, due to the MOTOR EFFECT, undergoes a mechanical stress and generates an ultrasonic
wave. The ultrasonic wave crosses the patients eye tissues, it is reflected by the echogen
structures and returns to the probe causing a mechanical stimulation to the ceramic that, due to
the GENERATOR EFFECT produces a small electric signal. The A/BSCAN HISCAN measures
the time delay from the excitation peak to the return wave (echo) and, as the propagation speed
of the ultrasonic wave in the eye is a known parameter, it uses this time delay, the echoes
amplitude and the transducer position to generate the image of the eye.

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5. SYSTEM DESCRIPTION
The A/Bscan HiScan - OPTIKON 2000 - is a unit, based on PC, for the imaging
of the ocular bulb and the measurement of the axial length of the eye and for
the calculation of the intraocular lens suitable for the restoration of the
emmetropia after the removal of the cataract. Reliability, versatility, accuracy
and simplicity, together with a pleasant and functional design, make the HiScan
unique among the various models available on the world market. The principal
functions can be performed by simply touching some keys on the basic module
of the system or on the pop-up menu of the PC.
The main characteristics are:

High resolution images

Up to 50 micron of axial and lateral resolution in the anterior segment (50 MHz probe). It is
possible to highlight minimum variations of the vitreo-retinal morphology (20 MHz probe).

Wide scanning field

Display, with only one scanning, of the entire anterior segment without the need of post-
processing.

B-scan movies
Movies recording of the B-scan window.
That function, can be used for the post analisys of the ciliary muscles movement during
accommodation and of the shifting of the lens or of the IOL.

High gain
Analysis of the Vitreal heterogeneity and corpuscles.

Double use
Wide diagnostic use of the anterior segment, posterior segment, of the vitreous and of the orbit.
Used for the pre/post measures of the lens and pre/post Lasik (ideal for the insertion of the
phakic lenses).

B-mode biometry
Accurate biometry also in patients with pathologies such as retinal detachment and hypermature
cataracts.

Large " data base "

Storage and display of all patients examinations.

Accuracy
Differential measurements also for the pseudophakic eyes in relation to the various kinds of
lenses.

Safety
Automatic standards (heuristics) for the acceptance of the measurements.

Immersion measurements
Cup to effect accurate immersions biometries

Last generation formulae

Accurate calculation also in case of high myopic eyes

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Manufacturer: OPTIKON 2000 S.p.A. ,Via del casale di
Settebagni, 13 00138 Roma.

Model: Ultrasound Imaging System A/BScan HiScan

5.3.1. Technical specification

5.3.1.1. B-MODE

Gain variable from 35 to 105 dB

TGC software from 0 to –30 dB
Contact probes 12.5 MHz and 20 MHz

Immersion probes 35 MHz and 50 MHz

Scan angle for contact probes 15° - 70°
Scan angle for immersion probes 10° - 30°
Immagine resolution (no interpolation) 256 lines x 2048 points
View zone from 30 mm to 60 mm
(zoom at 1)
Grey levels 256
Images Grey levels and colours
Axial resolution 50 microns
Lateral resolution 50 microns
Database dimension 500 kByte / image
Measures distance 1 and distance 2;
Angle; Area

5.3.1.2. BIOMETRY

Gain variable
Probe with fixation light 10 MHz
Mesurement zone from 1 to 60 mm
Electrical resolution about 30 micron

Operating modes phakic, cataractous,

aphakic,pseudophakic,
manual

Lens type PMMA, acrilyc,

silicone, “user def.”

Pagina 12
Velocity predefined for each eye
tissues and user defined

Other settings Eye with silicone oil

Measures average on till 5 measures

and standard deviation

5.3.1.3. ELECTRICAL AND MECHANICAL REQUIREMENTS

(computer and monitor are excluded)

Main 110/220 volt

Frequency 50/60 Hz
Power 120 VA max
Dimension (150 x 280 x 360mm)

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6. INSTALLATION AND USE

The package of the A/Bscan HiScan includes the followings parts:

Base
1) N°1 Base module up to 20 MHz or Expanded module up to 50 MHz
2) N°1 PCboard and cables
3) N°1 CDrom with HiScan software
4) N°1 CDrom with HiScan documentation
5) N°1 User Manual
6) N°1 Foot-switch "Freeze-Save" for Hiscan
Optional
7) N°1 expansion for basic module up to 50 MHz
8) N°1 PC complete of monitor, PCboard and cables instead of previous point 2.
9) N°1 Contact probe (12.5 MHz)
10) N°1 Contact probe (20 MHz )
11) N°1 Immersion probe (35 or 50 MHz)
12) N°1 Probe cable
13) N°1 Cup for immersion imaging
14) N°1 Probe for Biometry (10 MHz)
15) N°1 Test cylinder for biometry probe
16) N°1 Printer
17) N°1 Trolley complete of insulation transformer and a series of electrical connectors

Mechanical and electrical inspection has been performed on this unit before the
delivery. Before opening the box verify that the pack is not damaged. and If the content
is damaged due to transportation, notify it to the driver, to the retailer or directly to the
sales office of the OPTIKON 2000 for the immediate activation of the reparation or
substitution of the unit or the parts.

• Position the equipment in a comfortable way.

• Insert the jack of the pedal (optional) in the back panel of the basic module.
• Insert the special cable in the connector type D located in the back panel of the
basic module and in the PC and lock the screw.
• Connect the equipment to the mains (PC, Base module, Monitor and printer)
using the inlet available on the trolley.
• Insert the trolley cable into the main outlet.
• Connect the Bscan cable in the front panel of the unit
• Connect a Bscan probe (12.5 MHz, 20 MHz, 35 MHz or 50 MHz) to the cable
and put back the probe in the special probe holder of the basic module.

Pagina 14
• Turn on the general switch on the trolley and verify that the red light is on. If
the light is not on, verify the connection with the main.
• Verify the green light on the anterior panel of the basic module and the monitor.
Otherwise turn on the equipments through the special switches set near lights.
• Only after having effected with success all the preceding steps, press the button
of the PC and startup the system.
• After the system is on, select the probe installed on BScan (only for the version
3, since from the version 4 the probe is automatically recognized by the system)
and operate normally.
• During the pause, always leave the probe in the special probe holder and the
system in "Frozen". This guarantees a long duration of the probes that don't
need any type of maintenance.
• In the case of long operating pauses it is recommended to shutdown the system
following the procedure described herebelow.
• Don't forget to switch of the HiScan unit when the computer is switched off.

• Perform the computer “shutdown” (by means of the special button) and
positionate the switch of the trolley on “OFF” position.
• Verify that all the light are off. Don’t switch off any single equipment by
means of the specific button. Switch off the single equipment in case of system
disassembling or transportation.
• The HiScan unit must be always switched off if the computer is switched
off.

Pagina 15
After switching the unit on, the equipment displays the following image and the system
is able to work correctly.

In order to work properly the system automatically recognizes the probe used.
If it is necessary, it’s possible to select manually the type of probe through the special
pop-up menu:
From the menu"File"menu select "Choose Probe" and then the type of probe in use.

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 6.4.1. COMMANDS ON THE FRONTAL PANEL

From the frontal panel of the basic module it is possible to choose among the various
additional functions of the system.

The main commands are available also from the PC keyboards or mouse.
Commands description:
B-Scan - activates the BScan mode and the relative representation.
A-Scan - activates the AScan mode and the relative representation using the BScan
probes. If it is activated, the A type curve is overlapped to the B image. The toggle
button allows to the operator to switch on and off the function.
Biometry - activates the biometry function and the relative representation and sets the
tool for the use of the biometry probe.
IOL - the key is active if the system is in biometry mode, and in such case it allows to
effect the lens calculation.
Markers – The toggle button switches on and off the HiRes (High Resolution)
function. That function can be activated only with the immersion high frequency probes
(35 and 50 MHz probes). In HiRes mode, the scan angle changes from 30° to 10° and
the lateral field of view changes from about 16 mm to about 5 mm.
OD/ OS - it allows to change the selection of the eye (left or right) for the examination.
Freeze (Unfreeze) - ‘freezes’ on the display the image last acquired until this key or the
foot-switch are pressed again.

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Save - allows to save the whole examination (data and image) inside the patient
database.
Print - allows to print the examination.
Colors (Gray scales) - Activates / Disactivates in toggle way the visualization in false
colors of the ultrasound image in B mode. In the other modes the visualization is always
in grey scale.
Zoom - with the use of the arrows it is possible to increase or to decrease the value of
zoom of the image. The function is active both with frozen images or during the
acquisition.
Delay - moves the visualization zone. In case of magnified images it allows the
centering on the display.
Gain - allows to increase or to decrease the amplification. The function is active both
with frozen images or during the acquisition.
Energy - allows to vary the energy of the ultrasounds impulse transmitted by the
probes.
Select – allows to the operator the selection of the pulse duration length (the values
changes according also to the probes characteristics). That addictional function can be
used to maximize the performances of the equipment. In particular mode if shorter pulse
values are selected, the resolution of the equipment can be increased (but the deepness
of the analysis field will be reduced and also the brightness of the images). On the
contrary, if longer pulse values are selected, the field of view and the brightness of the
images are increased but the resolution can decrease. The last operational mode (longer
pulses duration) can be very helpful in case of eye with silicone oil inside or vitreous
analysis.
Enter – the first pressure of this button, during an examination, allows the operator to
start the movie recording and a new pressure stops the recording. In any case, about 20
seconds after the first pressure, the movie recording is stopped automatically. This
button is active only in B-Mode.

6.4.2. GRAPHIC USER INTERFACE

6.4.2.1. Introduction
Even if it is possible to use the equipment without changing any setting on the
computer, to activate some advanced functions it is necessary to use some available
graphic interface on the PC. This is particularly true for the functions related with the

Pagina 18
database (Patient, IOL, examinations). For convenience of the operator the interface
includes also all other functions available on the panel of the basic module.
The graphic interface for the operator of the HISCAN consists of a "main" window with
popup menu and bar of state. Inside said window there are:

• The window of the ultrasound image type A., B or A on B;

• The indicator with the name of the patient, the eye in examination (OD or OS),
Date and Time;

• The buttons of the operational modes and the main functions;

• The buttons for calipers (distance1, distance2, angle, area), for the software
zooming and for the selections cancellation;

• The command to switch from Low resolution to High Resolution and viceversa.

• The commands for movie recording and playback (The movies are linked in the
database to the selected patient and can be selected and executed directly from
the database tree);

• The "Zoom", "Delay", "Image size" and “Swept” indicators;

• The “d1”, “d2”, “Angle” and “Area" measurements indicators;

• The tree containing the names of the registered patients in alphabetical order;

• The "tabbed control" with the data of the patient, the data of the examination and
the possible biometry.

The main window size is unchangeable and the whole displayable area is occupied.

Pagina 19
 6.4.2.2. Main Menu
The main menu with sub-menus is the following:

Fig. 3

6.4.2.3. “File”sub-menuu
The “File” sub-menu options are the following:

• New Patient – Opens the window for the patient data insertion..

• Patients Manager – Opens the options for the managing of the patient records
(edit, delete, etc) of the patient database.

• Surgeon – Opens the window for the operator data insertion.

• Choose Probe – Opens the sub-menu for the probes selection (12.5 MHz, 20
MHz or 35/50 MHz).

• Probe Settings – Opens the windows for the probes parameters setting and for
the saving on the disk. (only for maintenance and not available to the operator)

• Save – Allows the complete saving (data + image) in the tests database.

• Print Preview – Shows the preview of the printed image.

• Export – Allows the exportation of the images in a standard format for the PC as
JPEG or RAW.

• Print – Prints the displayed image (or data).

• Exit – Exits to the OS. (not available to the operator)

Pagina 20
 6.4.2.4. “Freeze (Unfreeze)” sub-menuu
The “Freeze (Unfreeze)” sub-menu allows the operator to freeze and unfreeze in toggle
mode the images.

6.4.2.5. “Mode” sub-menu

The options of the “Mode” sub-menu are:

• B-Scan – Activates the Bscan operation and visualization mode.

• A-Scan – Activates the Ascan vector representation from the B probes. If also
the B mode visualization is activated, the Ascan is super-imposed on the BScan
image.

• Biometry – Opens the window for the Biometry acquisition and for the
acquisition type selection. Both the sub-menu functions activate the biometry
function and the biometry probe.

6.4.2.6. Sub-menu “Options”

The contents of the “Options” sub-menu are:

• Reset – For the factory values restore of the main settings (Zoom, delay, gain,
energy, pulse duration).

• OS / OD – Shows the eye selection windows..

• Show bang (Hide bang) – Enables / Disables in toggle mode the transmitted
pulse visualization. The transmitted pulse is visualized automatically when the
system is in the A-mode.

• Colors (Gray scale) – When the system is in B-mode, Enables / Disables in

toggle mode the false colour visualization of the ultrasound images. In the other
operating modes the visualization is in grey scale.

Pagina 21
 6.4.2.7. “Help” sub-menu
The Help sub-menu opens the About window of the application.

6.4.2.8. Main function description

The procedures of activation of the principal functions previously described are

herebelow described in detail, with particular attention to the sub-menu windows that
are activated recalling such functions.
Particularly they will be describing:
a) Operator Name
b) Biometry
c) Patient Database and examinations

6.4.2.8.1. How to select the operator

The name of the operator always comes in conjunction with the examination. Once
effected the selection this is memorized and the equipment will continue to use the same
name, also after turning off and re-boot, until a new selection is effected

Pagina 22
To insert the name of the operator is necessary to choose from menu the selection
"Surgeon."
The following form visualizes the window for the insertion of the name of the operator.
Once the operation is finished, press "OK."

6.4.2.8.2. Biometry
With the Biometry, the specific functions are activated.
All the functions of biometry (calculation of the intraocular lenses, measures, etc.) are
activated through the followings forms:
1. Biometry data
2. Biometry Settings
3. IOL Calculation
4. Keratometric Constants

5. IOL Database

“Biometry Data” module

The form visualizes the data related to the biometry (Anterior Chamber, Lens, Axial
Length) and it allows to select the type of examination (Phakic,...). Through such form
it is possible to check the correct execution of the biometric examination of the eye.

Pagina 23
When the measurement are acquired the related data are shown in the form. Normally
the system acquires automatically or manually till 5 measures.
In particular mode the AC (anterior chamber) the LENS (natural or artificial lens) and
the AXL (axial length) are acquired in Phakic or Pseudo-Phakic or Cataractous mode.
When the Aphakic mode is selected, only the AXL is acquired.
The possible acquisition mode are:
PHAKIC: Normal eye
PSEUDO-PHAKIC: eye with an IOL implanted
APHAKIC: Eye without the lens
CATARACTOUS: Normal eye with cataract
By means the checking of the “Immersion” option, it is possible to use the biometry cup
to perform the immersion biometry. In that case the first echo is not considered for the
measurements.
By means of the checking of the “Silicone oil” option, it is possible to adjust the
ultrasound velocity for the rigth measurements of eye with silicone oil inside.

“Biometry settings” module

The form visualizes "the tabbed page" related to the data of setting used by the routines
of calculation of the biometry. Through such control it is possible to recall, to modify
and to save the data related to the speeds of propagation of the sound in the constituent
materials of the intraocular lenses and in the eye.

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It is also possible to show and set the level of a threshold for the automatic biometry
data acquisition. A normal value for the threshold is about 60 but the operator must
change the value according to the characteristics of the eye.
If the echoes are highly attenuated it is better to decrease the value but if the echoes are
very high and many spurious echoes exists, due to the presence of vitreous alteration or
others, the threshold can be increased in order to avoid the freezing on unwanted
echoes.

Both eye and material velocity can be changed by the operator but in that case the
measured values for anterior chamber, lens and axial length will be affected. In
order to go back to the standard values, the “Restore Factory Defaults” can be clicked.
The operator can also change the values of the costants “a1” and “a2” used in the Haigis
formula for the IOL power calculation.

In any case, the change of any of the previous values must be operated by expert
user only.

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“IOL Calculation” module
The form visualizes the window through which the calculation of the intraocular lenses
is performed, using the parameters of measured biometry (axial length and anterior
chamber), the data contained in the lenses database , the keratometric constants and the
formulas availables in the same form.

Four different sections are on the previous form .

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“Keratometric constants” module
The form visualizes the window for the determination of the keratometric constants K
and R used in the calculation of the intraocular lenses. After the input of the values K1
and K2 or R1 and R2 click on the “Averages” button and automatically the average
value is calculated and also the R or K values.

“IOL Database” module

This module visualizes the form for the complete management of the IOL database.

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 6.4.2.8.3. Database Patients end examinations

The Patients database is composed by the following modules:

1. “New Patient” module
2. “Patient” module
3. “Test” module

“New Patient” module

It is activated through the "New Patient"sub-menu on the principal menu.
The form visualizes the window through which it is possible to insert or to edit the
registry data of the patient in the Patient database. The form for the insertion of new
data, also having the same aspect of it, it has different functionality from the form for
the change of the existing data.

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“Patient” module
The form visualizes the patient's data selected in the tree of the database.

“Test” module
The form visualizes the test’s data selected in the tree of the database.

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 6.4.3. How to use the HISCAN

After the system start-up it is possible to start with normal operation without special
setting.

ATTENTION:

• The use of some programs (as the continous scanning anti-virus) in the
same time of the HiScan, can reduce the performances of the equipment
(Scan rate can be drastically reduced).

• Don't forget to switch-off the HiScan unit when the PC is switched-off. The
green light on the front panel must be switched off.

6.4.3.1. General function

1) Selection of the operator name (F11 on keyboard or Surgeon on the display)

2) Selection of the patient name

a. For existing patient select the name using the Tree on the left of the
screen.

i. Click with the left button of the mouse on the (+) on the left
of the Tree.

ii. Click on the name of the patient if you want to select him as
the current patient.

iii. Click on the (+) on the left of the name and successively on
the (+) on the left of the date in order to see the list of
images.

iv. Click on the image number in order to select one (it appears
on the BSCAN screen).

b. For New patient push the F1 key or New Patient on the display and
the specific panel appears on the screen.

i. Insert the surname, name, etc. of the patient and push SAVE
(use the mouse pointer in order to advance from a box to
another box and to push the save or cancel)

ii. On the panel it’s indicated also the Current Database

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 iii. Only if the surname and the name are inserted it’s possible to
save the new patient.

6.4.3.2. How to use the B-SCAN

1) When the system starts the BSCAN function is automatically activated and
it’s possible to work just pushing the freeze/Unfreeze button (or footswitch).

2) Use the GAIN up and down arrow in order to adjust the gain on the image
(it’s useful to increase the GAIN in order to see the vitreous).

3) Use the ENERGY up and down arrow in order to change the energy of the
ultrasound pulses (PLEASE for normal use don’t change!).

4) Use the SELECT up and down button to change the pulse duration. In
particular mode if shorter pulse values are selected, the resolution of the
equipment can be increased (but the deepness of the analysis field will be
reduced and also the brightness of the images). On the contrary, if longer
pulse values are selected, the field of view and the brightness of the images
are increased but the resolution can decrease. The last operational mode
(longer pulses duration) can be very helpful in case of eye with silicone oil
inside or vitreous analysis.

5) Use the S/Rate up and down arrow in order to select the scale of the images
(Please don’t change in normal use, the system automatically select the best
scale for each probe).

6) Use the ZOOM up and down key and the Delay up and down key to adjust
the zooming and the longitudinal position of the image.

7) If the patient is not selected the current patient name is “Anonymous”, in

other case, select the patient name from the tree on the left or add a new
patient (when you add a new patient, it’s automatically selected as the
current Patient).

8) Select the eye to be observed using the toggle key F6 or the OS/OD button.

9) Pushing the SAVE button (on the panel or on the footswitch) the current
image is saved on the current Patient.

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10) On the frozen image or on the saved images it’s possible to make
measurements using the buttons on the right of the BSCAN screen.

a. For distance measurements, click with the left button of the mouse on
(d1) or (d2) icons, then click with the right button of the mouse on
the start point to be measured and, maintaining the button down,
move to the end point of the segment and release the button of the
mouse.

b. For Angle measurements, click with the left button of the mouse on

( ) icon, click on the vertex of the angle to be measured and,

maintaining the button down, move to the first segment, release and
click again the button and move to the next segment.

c. For Area measurements, click with the left button of the mouse on
(A) icon, right click and follows the perimeter of the surface to be
measured. Release the mouse button to complete the measurement.

d. To Zoom on the image, click with the left button of the mouse on (+)
icon, right click and move on the image to be zoomed.

e. In order to erase any previous measurement, click with the left button
of the mouse on (X) icon.

11) Pushing the F8 key or the Colour button it’s possible to change the image
from Black and White to false color and viceversa.

12) In order to print the image, push the F9 key or the Print button (if the printer
is installed on the PC).

13) When the BSCAN is running, click on the red dot on the right of the
BSCAN screen in order to start the recording.

14) After about 20 seconds the recording stops automatically and the movie is
stored in the database. The file is saved in AVI standard and can be
visualized in windows operating system (Windows 2000, Windows XP).

15) Clicking on the green triangle on the right of the Bscan screen it is possible
to recall the movie to playback.

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 16) Clicking the “Hi” button on the screen or the “Marker” button on the main
panel of the Hiscan Unit it is possible to activate the High Resolution
function. This function works only with the immersion probes (35MHz and
50 MHz probes) and allows to the operator to see the image with an higher
resolution. Activating that function, the lateral field of view becomes about 5
mm instead of the about 16 mm of the normal resolution mode. In order to
go again to that Low resolution it is necessary a second click on the “Hi”
button on the screen or the “Marker” button on the main panel of the Hiscan
Unit.

6.4.3.3. How to use the ASCAN on BSCAN

1) On a BSCAN image it’s possible to make the ASCAN just pushing the ASCAN
button or F3 key.

2) Left click on the line at the center of the screen and, maintain the button down,
move the pointer of the mouse in order to explore the BSCAN image.
Consequentely the Ascan image on the BSCAN screen changes according to the
position.

6.4.3.4. How to use the BIOMETRY

1) Push the biometry button or the F4 key (the biometry probe will be
automatically selected).

2) Unfreeze the system. A red moving line appears on the screen.

3) Use the GAIN up and down arrows in order to adjust the gain.

4) Select the manual or auto mode of operation.

5) Select the type of the eye (Aphakic, Phakic, Pseudophakic, Cataractous)

6) Select Immersion if you want to operate with the immersion cup.

7) Select Silicone Oil if the eye is filled with silicone oil.

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8) Perform the measurement of the eye (if Auto is selected, the system autofreezes
and saves at the end of each measurement. In order to make the successive
measurement the system automatically unfreezes after a certain time (normally 3
sec). In Manual mode it’s necessary to freeze and save manually).

9) Pushing the F7 key or the Setting button, a panel for setting the velocity of the
ultrasound inside the eye and for setting some constants, appears.

a. Corneal is the US velocity inside the cornea.

b. Acqueous is the US velocity inside the Acqueous humor.

c. Vitreous is the US velocity inside the Vitreous humor.

d. Lens is the US velocity inside the natural lens.

e. Average is a mean value useful for internal calculation.

f. PMMA is the US velocity for pseudophakic eye having a PMMA Intra

Ocular Lens (only for the lens section).

g. Acrylic is the US velocity for pseudophakic eye having a acrylyc Intra

Ocular Lens (only for the lens section).

h. Silicone is the US velocity for pseudophakic eye having a silicone Intra

Ocular Lens (only for the lens section).

i. Silicone Oil is the US velocity in the silicone oil.

j. User defined is an additional possibility for new lens (if any).

k. Marker moves the white line on the screen and is the threshold for
automatic freezing on the biometry echoes (70 is a recommended value)

l. Noise is the noise level for biometry display; It depend by the gain but a
value between 0 and 50 it’s reccommended (It’s only for display and
don’t have any effect on the measures!)

m. (a1) and (a2) are constants for the Haigis IOL calculation formula.

10) Pushing the F8 key or the IOL button, the IOL selection panel appears.

a. The measured Axial length (AXL) and anterior chamber (ACD), if any,
are automatically copied in the boxes.
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b. Add the K value (clicking on the box at the right of the “Average K” it is
possible to introduce K1 and K2 or R1 and R2 and the system
automatically calculates the average (if you insert the R1 and R2 values
the K1 and K2 are also calculated).

c. Select the IOL from the database (Lens Style) and automatically the lens
data are written in the specific boxes (A, SF, and ACD constants).

d. At the beginning the IOL database is empty and it is necessary to add the
lens data.

1) Clicking on the “IOL Database” button a specific panel appear

and it is possible to add the caracteristics of the new lens. When
a new lens data is inserted, click on the save button on the IOL
panel (the box with the floppy disk image).

e. Now select the IOL calculation formula to be used and the system
automatically performs the calculation.

f. Click on the Print button of the IOL panel and the IOL data to be
implanted will be printed out (if the printer is installed on the PC)

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