Cod.

141002EN
26.10.05 Rev.0

BIOLINE
PORTABLE BIOMETER
INSTALLATION AND OPERATING MANUAL

OPTIKON 2000 S.p.A.

Via del Casale di Settebagni, 13 - 00138 Rome Italy
Tel. +39 06 8888355 - Fax. +39 06 8888388
e-mail mailto:[email protected] - www.optikon.com
OPTIKON 2000 SpA is an ISO 9001 and ISO 13485 certified company
which manufactures surgical and diagnostic devices for ophthalmology.

Its products are manufactured to satisfy the requirements of 93/42/EEC

Medical Devices Directive.
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 ...................................................................................... 5-2
5.3 CIRCUIT DIAGRAMS ....................................................................................................... 5-5
6 INSTALLATION ..........................................................................6-1
6.1 INTRODUCTION .............................................................................................................. 6-1
6.2 UNPACKING AND INSPECTION..................................................................................... 6-1
6.3 INSTALLATION PROCEDURE ........................................................................................ 6-1
7 EQUIPMENT OPERATION ........................................................7-1
7.1 EQUIPMENT LAYOUT ..................................................................................................... 7-1
8 OPERATION ..............................................................................8-1
8.1 AUTOTEST SESSION...................................................................................................... 8-1
8.2 A-SCAN MEASURING SESSION .................................................................................... 8-1
8.3 A-SCAN KEY FUNCTIONS .............................................................................................. 8-2
8.4 SETTING UP THE A-SCAN EXAMINATION.................................................................... 8-3
8.5 IOL CALCULATION SESSION ......................................................................................... 8-5
8.6 FUNCTION OF THE KEYS IN THE IOL CALCULATION ................................................ 8-6
8.7 SETTING UP THE IOL CALCULATION ........................................................................... 8-6
8.8 PROBE TEST ................................................................................................................... 8-8
8.9 SHUT DOWN PROCEDURE............................................................................................ 8-9
9 CLEANING, STERILISATION AND MAINTENANCE.................9-1
9.1 CLEANING........................................................................................................................ 9-1
9.1.1 UNIT ............................................................................................................................. 9-1
9.1.2 ACCESSORIES............................................................................................................ 9-1
9.2 STERILISATION ............................................................................................................... 9-1
9.2.1 UNIT ............................................................................................................................. 9-1
9.3 MAINTENANCE................................................................................................................ 9-1
9.3.1 UNIT ............................................................................................................................. 9-1
9.3.2 ACCESSORIES............................................................................................................ 9-2
9.3.3 REPLACEMENT OF THE PRINTER PAPER .............................................................. 9-3
10 TROUBLESHOOTING GUIDE .................................................10-1
11 INDEX.......................................................................................11-1
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1 DISCLAIMER
OPTIKON 2000 S.p.A. requires the user of this system to carefully read specific
warnings found in this manual. It is responsibility of the user to provide its personnel
with a thorough understanding of the equipment operation 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 operation of the
product.
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 equipment and makes no medical recommendations.
OPTIKON 2000 S.p.A. declares to be liable for safety, reliability and performance
only if:
upgrades, calibrations, repairs are carried out by OPTIKON 2000 S.P.A.
authorized personnel;
the system is used in accordance with its instructions for use;
the mains electric installation to which the system is connected complies with
the IEC Safety Regulations.
IMPORTANT NOTICE
Every effort has been made to have all the illustrations and information
accurately represent the product and its operation as it actually was at the time
this operation manual was printed. Changes in some items may be made
during the life of this manual, so that we may effectively continue to meet the
requirements of users. On occasion, these changes may be made without
notice.
OPTIKON 2000 S.p.A.

Via del Casale di Settebagni, 13

00138 Rome - Italy
Phone +39 06 8888355
Fax. +39 06 8888388
e-mail [email protected]
www.optikon.com

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.

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2 LIMITED WARRANTY CONDITIONS

All OPTIKON 2000 S.P.A. equipment and accessories sold and installed in the European
Union are guaranteed against defective workmanship and material faults for ONE YEAR,
from the date of the invoice. Warranty on consumable materials is limited to the first use
Please, inquire with your local Optikon Distributor for warranty conditions in countries
outside the European Union.
All items under 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 unit, or part(s).
This warranty does not cover the results of misuse, accident, abuse and tampering or
alteration done by anyone other than personnel authorized by OPTIKON 2000 S.p.A.
OPTIKON 2000 S.P.A. reserves the right to ascertain, in case of faults, whether or not the
equipment and/or its accessories have been altered, tampered with, in any way, or have
been damaged by improper use.
OPTIKON 2000 S.P.A. also reserves the right to modify the equipment and/or its accessories
whenever operating techniques necessitate modification(s).
No warranty will be recognized if serial number of the equipment and/or accessories
attributed by OPTIKON 2000 S.P.A. is missing, tampered and/or not clearly readable.
Warranty does not include expenses for return shipment of equipment and accessories: all
expenses for transport, packing etc. are to be borne by the purchaser.
In case of an expressly requested intervention of our technicians, all travel and hotel
expenses will be debited to the client.
OPTIKON 2000 S.P.A. cannot be held liable for damages caused by transportation. If this is
the case, the customer should apply at once to the carrier that handled the consignment.

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3 WARNINGS
The following warnings will help the user to operate the BIOLINE OPTIKON 2000
biometer correctly, resulting in safe use, free from any problems.

General
All the medical personnel working with the instrument must read and understand
the instructions provided in this manual before the system is used. If your
instrument does not behave in the way described in this manual, do not attempt to
use it.
The use of this system is in any event subject to professional medical opinion.
Optikon 2000 s.p.a. cannot be held responsible for any problems of a medical
nature resulting from incorrect use of this instrument, and nor does it make any
recommendations of a medical nature.

Environmental
Do not install the instrument close to sources of heat or expose it to direct
sunlight or high temperatures.
Do not install the instrument in such a way that the ventilation slots are
obstructed.
The system must never be used in the presence of inflammable anaesthetics,
inflammable disinfectants, or other substances which may cause fires or
explosions.
The use of flammable anaesthetics (N20, 02), should be avoided unless they are
removed by a gas aspiration system.
Do not dispose of the BIOLINE unit as unsorted municipal waste. Collect it
separately according to the local laws/regulations on disposal of waste electrical
and electronic equipment.

Electrical
The BIOLINE instrument is provided with thermal protection (with ptc) against
overheating and against any internal short circuits. Consequently no fuses need
to be replaced.
In order to reduce the risk of electric shock, do not remove the cover of the
instrument or the mains adaptor. Employ qualified technical personnel to carry
out maintenance and repairs.

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The standard AC-DC adaptor must be used exclusively to supply the instrument.

Ordinary maintenance
Do not sterilise the probe in hot air or in a chemical autoclave.
Do not use solvents or alcohol to clean the exterior of the instrument.
The probe (and the relating packaging) is not supplied as sterile and must be
disinfected before it is applied to the cornea.

Precautions relating to the normal use of the instrument

Gently apply the probe to the moist cornea, avoiding changing its normal
geometric arrangement.
If you are in doubt about the accuracy of the measurement carry out a
calibration test on the probe and in the event of a negative result or incorrect
functioning, do not use the instrument and seek technical assistance.
Thermal prints tend to deteriorate in time. For long-lasting storage it is advisable
to keep a photocopy of the print.
Turn off the instrument at the switch when not in use

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4 SYMBOLS
Table shown below reports some symbols approved by I.E.C. and their meaning.
When there is not enough room, they are frequently used on medical equipment to
enable an easy and fast communication of information and warnings. Sometimes two
or more symbols may be assembled to obtain a special meaning.
These symbols are used on the BIOLINE label. Before starting to use the unit, you
should familiarize yourself with them and their definitions shown in the table.

SYMBOLS PUBLISHED BY THE IEC

SYMBOL DESCRIPTION

ALTERNATING CURRENT

DIRECT CURRENT

PROTECTIVE EARTH
(GROUND)

ATTENTION CONSULT
ACCOMPANYING
DOCUMENTATION

OPEN (POWER
DISCONNECTED FROM THE
MAINS)
CLOSED (POWER
CONNECTION FROM MAINS)
TYPE B APPLIED TO THE
PATIENT (BODY)

TYPE BF FLOATING PART

APPLIED TO THE PATIENT
(BODY-FLOATING)
SEPARATE COLLECTION OF
WASTE
ELECTRICAL/ELECTRONIC
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. They showed that certain types of crystals (quarz,
tourmaline), when deformed by mechanical causes, generate an internal electric
field. Vice versa when an electric field is applied to these crystals, mechanical
distortion of the material occurs. Some ceramics, treated in an appropriate way using
a polarisation process, acquire the piezoelectric properties of natural crystals. These
ceramics, obtained using up-to-date technology, are defined as piezoelectric. The
BIOLINE probe contains a piezoelectric ceramic which, when stressed with an
electrical impulse vibrates at the frequency of 10 megahertz (10 million oscillations
per second). This movement of the ceramic transductor generates an extremely low
energy ultrasound wave which crosses the cornea, aqueous humor and any other
objects or tissues found along the signal propagation pathway. The ultrasound wave
partly crosses the obstacles and is partly reflected by the latter towards the source
(namely the actual transductor). It takes this reflected energy a certain amount of
time to turn towards the transductor and this time is proportional to the distance from
the obstacle. The measurement of this time and the experimental knowledge of the
speed of the echo, allow the distance from the object (the retina for example) from
the emitter (probe tip) to be mathematically calculated. The characteristics of the
return echo are then processed by a fast microprocessor which detects its reliability
for measuring purposes (automatic acquisition).

5.1 SYSTEM DESCRIPTION

The portable BIOLINE - OPTIKON 2000 Biometer is a portable microprocessor-
based instrument for measuring the axial length of the eye and for calculating the
intraocular lens appropriate for restoring emmetropia, after removing the cataract.
Reliability, versatility, accuracy and simplicity, together with an attractive and
functional design, make this a unique instrument among the various models available
on the world market.
The principal functions are activated by a few dedicated keys. All the other
parameters can be changed by using the four lateral arrows. Presentation of the
echo in real time allows the operator to line up the probe easily even in the most
difficult cases. In order to carry out the measurements more easily it is possible to
select signalling with voice synthesis of standard deviation, in addition to traditional
signalling with acoustic tones. Finally the internal thermal printer provides an
accurate recording of the measurements taken as well as the parameters relating to
the selection of the intraocular lens.

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5.2 TECHNICAL SPECIFICATIONS

PARAMETER SPECIFICATIONS
Manufacturer:............................... OPTIKON 2000 S.p.A.
via del Casale di Settebagni, 13
00138 Rome - Italy
Model: .......................................... BIOLINE
Regulatory compliance: .............. 93/42/EEC Medical Devices Directive (MDD)
Technical standards: ................... EN 60601-1 ; EN 60601-1-1 ;
EN 60601-1-2 ; EN 60601-2-2

ENVIRONMENTAL SPECS
Storage: ....................................... temp range 10C to +70C, humidity 10-100%
(non condensing)
Operation: .................................... temp range +10C to +40C, humidity 30-75%.

ELECTRICAL SPECS
Input voltage: ............................... 100/120 or 220/240 Volt AC
Frequency:................................... 50/60 Hz
Power consumption: .................... 24 Watt Max
Line fuses .................................... N.A.
Supplier protection:...................... automatic thermal switch
Instrument protection: .................. automatic thermal switch

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PARAMETER SPECIFICATIONS

TECHNICAL SPECIFICATIONS
Probe: piezoelectric with fixing light, which can be
assembled on tonometric slide
Frequency: .................................. approx. 10 MHz
Clinical accuracy: ........................ 0.1 mm.
Resolution: .................................. 0.06 mm.
Field of measurement:................. 18-36 mm.
Screen: ........................................ Liquid crystals 240x128 dots.
Speed of presentation: ................ 20 frames per second.
Printer:......................................... 40 columns - 320 dots, thermal.

Modes of measurement:.............. Automatic and manual.

Measurements in the memory: .... up to 5 with indication of average and
standard deviation
Echo amplification: ...................... Manual in 7 levels or Self-regulation
Calculation formula:..................... SRKII , Haigis, Holladay, Gernet, SRK/T
Lens memory:.............................. Up to 15 lenses, with relating storable parameters

Acoustic signalling: ...................... Sound or voice synthesis, selectable

Outputs
For computer: RS232, with 9 pin connector.
For the optional footswitch, with 2 way jack

Acoustic Output Parameters according to IEC/EN/DIN 61157 standard

See page 5-4

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Acoustic Output Parameters

according to IEC/EN/DIN 61157
Manufacturer: Optikon 2000 SpA
Device: Bioline (ref.141002)
Transducer: Biometry probe, 10 MHz (ref.143001)

Parameter Unit Mode A

Maximum Power [mW] 0.003 0.001

Peak negative acoustic pressure [p-] [MPa] 1.3 0.14

Output beam intensity [IOB] [mW/cm] 0.006 0.001

Spatial peak temporal average intensity [ISPTA] [mW/cm] 0.2 0.04

Focal length [lp] [mm] 22.6

Pulse beam width (6 dB, parallel) [wpb6 ] [mm] 0.75

Pulse beam width (6 dB, orthogonal )[wpb6 ] [mm] 0.82

Pulse repetition rate [prr] Hz 20

Scan repetition rate [srr] Hz ---

[mm] 3.1
Output Beam Dimensions
[mm] 3.4

Arithmetic-mean acoustic working frequency [fawf] [MHz] 10.8

Transducer to transducer output face distance [ltt] [mm] ---

Transducer standoff distance [lts] [mm] Contact

Power up fraction 100 %

Acoustical initialization fraction 100 %

Power up mode Default

Initialization mode Default

Freeze output Yes

Modes included ---

Control settings ---

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EQUIPMENT CLASSIFICATION ACCORDING TO IEC 601-1

Type of protection against
electrical discharge: ..................... Class II
Degree of protection against electric shock
U/S:.............................................. type BF
Degree of protection against
harmful ingress of water: ............. IPX1
Degree of safety of application
in the presence of a flammable
anaesthetic mixture:..................... not applicable

DIMENSIONS
Height: ............................................... 15 cm
Width: ................................................ 23 cm
Depth:................................................ 29 cm
Weight: .............................................. 2.2 Kg

NOTE:
1) Weight and dimensions shown are approximate.
2) Specifications are subject to change without notice.

5.3 CIRCUIT DIAGRAMS

OPTIKON 2000 S.p.A. will make available on request circuit diagrams, component
part lists, descriptions, calibration instructions, or other information which will assist
the user's appropriately qualified technical personnel to repair those parts of
equipment which are repairable.

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6 INSTALLATION

6.1 INTRODUCTION
This section details the recommended procedure for installing and checking the
operational functions of the BIOLINE unit.
The operational checks, however, which are performed after the system installation
to verify equipment operation, must be performed exactly as indicated and should not
be regarded as recommended practice or encouragement for any diagnostic
procedures.
To bring your biometer in operation, a series of cable, footswitch and probe
connections must be made.
Follow the installation and operating instructions carefully in a step by step manner
and, within a short time, you will have gained all the knowledge needed for
successful operation of your biometer.

6.2 UNPACKING AND INSPECTION

This unit has been packaged to minimize the risk of damage in shipment. Unwrap the
package and examine the components. Handle all components with care during
unpacking. Use caution cutting the wrapping to ensure that the cut does not
penetrate the packing and damage the components. If external or internal shipping
damage is discovered, notify the carrier (mail, railways or forwarding agents) and
Optikon 2000 as soon as possible. Check the contents against the packing list and
notify Optikon 2000 immediately of any discrepancies.

6.3 INSTALLATION PROCEDURE

NOTE
The operator is responsible for cleaning and disinfecting probes and reusable accessories

The following procedure should be observed to install the system:

Position the instrument in a comfortable way.

Insert the footswitch jack (optional) in the rear panel.
Insert the AC/DC adaptor in the 220 volt socket and the 12 volt connector in the rear
panel.
Connect the biometry probe to the front panel.

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7 EQUIPMENT OPERATION

7.1 EQUIPMENT LAYOUT

FRONT PANEL (FIG.1)

1) LIQUID CRYSTAL DISPLAY (LCD)

Flat screen for presenting graphics and measurements. This screen has the
characteristic of being fully legible in solar light as well as in poorly lit surroundings,
thanks to backlighting. For maximum performance, position the instrument facing the
observer. Adjust the contrast and brightness to the best possible setting.

2) CLEAR KEY
On the measurement page, by pressing the CLEAR button once, the graphic
displayed is cancelled and the relating measurement cleared. To cancel all five
measurements in the memory press the CLEAR key a second time. Make sure that
all the measurements have been cancelled before starting with a new patient (eye).

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3) A-SCAN KEY
Displays the measurement acquisition page with the relating A-SCAN graphic. In the
course of acquisition this same key alternately starts and ends the acquisition.

4) IOL KEY
Displays the page for calculating the intraocular lens, with results which also relate to
correction with spectacles or contact lenses. On the calculation page it selects the 2
principal lenses alternately.

5) D-BASE KEY
Not active in this version. Prepares any interface with an external computer for
patient archiving.

6) SET KEY
Displays the page for setting up the instrument. On this page all the settings for the
lens constants and the biometric examination can be cancelled, and the language for
printing the user guide can be selected.

7) PRINT KEY
Sends the printer the results of the biometry and the IOL calculation.

8) ON LED
This indicator signals the presence of supply voltage when the rear switch is in the
ON position.

9) POINT/ ENTER Key

Press this key to confirm and close the selection of parameters indicated on the
screen.

10) PROBE SOCKET

Input for the biometry probe connector.

11) ARROW KEYS

These are general use keys for changing and entering data. In general, the vertical
arrows are used to select a parameter from those displayed on the screen; the
horizontal arrows, on the other hand, are generally used to change the value of the
parameter selected.

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REAR PANEL (FIG.2)

1) FOOTSWITCH SOCKET
Input for the footswitch connector (optional). The footswitch closes down and
reactivates the biometric measurement on the acquisition page (in a similar way to
the A-SCAN key).

2) RS232 CONNECTOR
Socket for possible connection to a computer (not supported by the current version of
the programme).

3) PLATE
Shows the data on the instrument plate and the serial number.

4) SUPPLY INPUT
Input socket (low voltage) for connection to the feeder model 142001/142002 or to
another source with equivalent characteristics.

5) MAIN SWITCH
Activates and deactivates the instrument supply (display of the symbol O indicates
the off position).

6) BRIGHTNESS CONTROL
This small potentiometer allows the back lighting of the screen to be adjusted from 1
to 9. Adjust to achieve good screen visibility.

7) LCD CONTRAST
This small potentiometer allows the screen contrast to be adjusted in an optimum
way, depending on the visual angle of the screen.

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8 OPERATION

8.1 AUTOTEST SESSION

Turn on the instrument using the switch at the back. The instrument automatically
carries out certain tests, then records the following information on the screen:

SELF TEST: Shows the result of the system test (normally Passed otherwise
the error code ERR.XXX).

PRINTER: Indicates whether the printer is connected (Ready or Absent)

PC-LINK: Indicates whether the connection via RS232 to the personal

computer has been found (Ready or Absent).
One of the sessions indicated in the line at the bottom of the screen can be
selected from this page: A-SCAN - IOL HELP. A simple command memo can
be printed by pressing the PRINT key or the paper can be pushed forward by
pressing the key Arrow up (useful for loading a new roll).

NOTE:

If the self test identifies an error in the memory, a warning message is displayed, before you proceed
to cancel the whole memory:

DELETE ALL DATA IN MEMORY?: YES. Press the Enter key. The data on the intraocular lenses
must then be re-entered by the operator.

8.2 A-SCAN MEASURING SESSION

In the A-scan session, the display shows either the parameters for selecting the
operating mode or the results of the individual biometry. In addition the average of a
maximum number of five biometries and the resulting standard deviation is indicated
in large figures.
It is possible to bring up each of the 5 measurements taken and the relating graphs,
by pressing the left and right arrow keys.
The keys lined up under the display allow the most frequently used functions to be
activated.

The A-scan session page provides the following information:

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The moving A-SCAN graphic allows the operator to check that the probe is
correctly lined up during the examination. After the image is automatically
frozen the A-scan graphic helps to evaluate the quality and accuracy of the
measurement. Two arrow-shaped symbols known as markers indicate the
base of the corneal peak and that of the retina respectively, from which the
axial length of the eye is calculated.

The length of the anterior chamber (AC) the thickness of the lens (LNS) and
the axial length (AXL).
If the mode is manual (MODE = MAN.GATE) or the eye is aphakic, only the
axial length AXL is indicated. All the measurements are in millimetres.

The average of the measurements stored (up to 5). This is indicated in larger
figures; under the average axial length the number of averaged measurements
(AVG = nSamples with n from 1 to 5) is indicated. It is advisable to take from
three to five measurements per patient. The accuracy of the measurements is
deduced from the standard deviation (indicated as +-x.xx in small figures, to
the right of the average). The standard deviation can be indicated vocally if the
mode PRMT:VOX is selected.
The standard deviation of a series of accurate measurements must not exceed
+/-0.3 mm. It is possible to increase the accuracy of the average by taking new
measurements. If 5 measurements have already been taken (maximum
number), the new measurement automatically replaces the worst of those in
the memory.

8.3 A-SCAN KEY FUNCTIONS

In order to simplify the use of the instrument very few keys have been used. Some of
these are reserved for the most frequent operations. In the A-scan session the keys
have the following functions:

CLEAR Clears the A-scan graphic and the measurement displayed on the
screen. By pressing the CLEAR key again all the measurements in the
memory are cleared; the latter operation generally precedes the examination
of the other eye or that of a new patient.

NOTE: It is possible to recover measurements cancelled by mistake. To do this turn

the instrument off immediately after any cancellation and then turn it back on.

ASCAN...Starts or interrupts the acquisition of the A-scan. The same function

can be carried out using the optional footswitch. The two modes are indicated

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by the following wording on the screen: RUN X and STOP X respectively, with
X from 1 to 5
Activation starts up a series of 5 measurements interspersed by a brief pause.
After the acquisition of the fifth measurement a dual tone indicates that the
series of measurements has been completed.

ARROWS < and >: The 5 memories available for biometric

measurements are brought up in succession. (The measurement is
automatically saved when it is taken).

IOL: Forwards to the lens calculation session. The axial length obtained from
the average of the measurements (indicated by AVG) is automatically sent on
to the calculation page.

SET: Allows certain configuration parameters to be reset. The configuration

menu allows either cancellation of all the data stored about the lenses, or
selection of the language (English or Italian) for any printing out of the rapid
user guide.

D-BASE: Forwards to the archiving session if the connection with an external

personal computer is present (via port RS232). If the connection is not
present, the autotest page is displayed.

PRINT: Starts up the printing of the graph and the biometry results. If several
measurements are displayed the one closest to the average is displayed and
sent to be printed.

8.4 SETTING UP THE A-SCAN EXAMINATION

The operating parameters (EYE, MODE, GAIN, PRMT) indicated at the bottom left of
the screen, can be displayed one at a time and modified as follows:

1. Press the ENTER key or the vertical arrows; in this way one parameter for the
input is displayed.
2. Now press the up-down arrows again to move to the desired parameter. Use
the left-right arrows to change the value of the parameter.
3. Finally press the Enter key to close the input and return to operating mode.

The parameters of the A-SCAN session are as follows:

EYE : Specify OS-REF, OD-REF, OS, OD, to indicate, respectively,

reference Left Eye and reference Right Eye, Left Eye (principal), Right
Eye (principal). The selection of a reference eye prior to examining the

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principal one, allows the axial measurement of this eye to be retained,

even after the double CLEAR . At the time of printing, the measurement
of the reference eye is indicated together with the axial measurement
and the A-Scan graph of the principal eye.

MODE : Defines the conditions for acquiring the measurement

APHAKIC : Enables automatic acquisition for an aphakic eye. If peaks

are revealed in the lens zone the message MODE ERR (mode error)
is indicated.

PHAKIC : Enables automatic acquisition with non-cataractic lens.

CATAR. : Enables automatic acquisition with normal or cataractic eye.

PS.PHAK.: Enables automatic acquisition in the case of an artificial

lens

WB.CATA.: For immersion examination (without direct contact between

probe and cornea). Enables automatic acquisition in the case of a
normal or cataractic lens

MAN.GATE: Mode with manual acquisition via A-SCAN or footswitch

key. In any event an automatic procedure for identifying the type of eye
(phakic or aphakic) is active for the correct calculation of axial length. If
the A-scan is frozen it is possible to measure the axial length relating to
peaks other than the one indicated by the marker (small arrow at the
base of the peak). To move the marker to another peak, display EXAM
= MAN.GATE (vertical, then horizontal arrows) then press the key >
. The marker moves to the next peak and the measurements AXL and
AVG will be updated as a result. Finally press Enter to confirm the
measurement indicated and return to operating mode.

NOTE: AFTER ACQUIRING THE A-SCAN IN ONE OF THE AUTOMATIC MODES, IT IS HOWEVER POSSIBLE TO MOVE
TO MAN.GATE MODE IF YOU NEED TO SELECT A DIFFERENT RETINAL PEAK.

GAIN.: Selects the level of echo amplification; from MIN (minimum) to MAX
(maximum) in seven levels. MED/HIGH or MED. are the values normally
recommended. There is also the option GAIN = AUTOSET which allows
automatic adaptation of the amplification to optimum level.

PRMT.: Selects the acoustic signalling mode: BEEP for tone signalling, VOX
for voice signalling of the standard deviation.

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8.5 IOL CALCULATION SESSION

This session allows the power of the intraocular lens, spectacles or contact lens to be
calculated after having specified the two keratometric constants K1 and K2. The axial
length is sent directly from the A-scan session. The type of lens can be selected from
a group of 15 lenses distinguished from one another by their respective serial
number.

The following three values are associated with each lens:

1. ACD : length of the anterior chamber (used in the theoretical formulae).

2. A: Constant A (used in the SRK formula).

3. SF: Surgeon Factor (constant used in the HOLLADAY formula ). If SF = -9.99

the value of SF is taken from the constant A of the lens. Specify -9.99 if SF is
not known.

The aforementioned constants can be changed and remain stored with the relating
lens. The result of the calculation is a table with 5 values, power and refraction,
graded in half diopters. The powers of the contact lens (CONTACT) and the
spectacles (APHAKIC) are also indicated.

An alternative method of inserting the keratometric constants K1, K2 is available in

the form of corneal radius of curvature (in mm), rather than dioptres. In order to
select the format of these values, enter on the preset page by pressing the SET key.

Use the arrow at the bottom in order to move to the last row K READINGS UNITS:;
select using the horizontal DIOPTERS arrows for dioptres or RADIUS MM for
corneal radius of curvature.

Press the Enter key to finish.

On the IOL calculation page, the two rows at the bottom will indicate K1 ,K2 for the
dioptre format or R1, R2 for the radius of curvature format, depending on the
previous selection.

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NOTE: THE MEMORY OF THE LENSES, THE RELATING CONSTANTS AND THE SETTING OF THE A-SCAN, IS
SUPPLIED BY AN INTERNAL 3.6 VOLT LITHIUM BATTERY, LASTING FOR APPROXIMATELY TEN YEARS. IF THE
BATTERY RUNS DOWN THIS WILL NOT PREJUDICE THE EXAMINATION PROCEDURE OR ITS ACCURACY.

8.6 FUNCTION OF THE KEYS IN THE IOL CALCULATION

A-SCAN: Returns to the A-Scan session.

PRINT: Sends the results of the IOL calculation for printing

IOL: Selects one of the two principal lenses, alternately. This key allows the
immediate recalculation of the power-refraction table for the lenses normally
used, referred to as principal lenses. To select the two principal lenses from
among the 15 available ones, simply:
1) Display the IOL field (using the up-down arrows)
2) Bring up the desired lens (right-left arrows)
3) Press the IOL key to store the first principal lens.

Repeat the above for the second lens and end by pressing Enter.

D-BASE: Forwards to the archiving session if there is a connection with an

external personal computer (via port R5232). If there is no connection, the
autotest page is displayed.

NOTE: THE AFOREMENTIONED KEYS ONLY WORK IF NO FIELD IS DISPLAYED. IN ORDER TO TERMINATE THE
INPUT FROM A DISPLAYED FIELD, PRESS THE ENTER KEY.

8.7 SETTING UP THE IOL CALCULATION

In order to change the parameters (type of lens, constants A, ACD, SF K1, K2, AXL,
power PW and refraction RF), use the group of keys on the right of the screen.

First of all select the parameter to be changed (up down arrows), then use the
right- left arrows respectively in order to increase - decrease the value displayed.
Press Enter to confirm the value.

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If the value is a number with an integer part and a decimal part the cursor moves to
the decimal part. Use the keys <-- and --> again to change the decimal figures and
end with Enter, or move to another parameter requiring a change.

Prolonged pressure on the keys <-- and > produces a rapid increase and decrease
in the number displayed.
If the input of one parameter is closed (using the Enter key), the PW-RF table is
recalculated.

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8.8 PROBE TEST

It is possible to carry out a test to check the functioning of the probe and the
accuracy of the biometric measurement. To this end a small tube of transparent
plastic 149001 is supplied on which the value of the measurement test is indicated in
millimetres together with the tolerance (+/-0.1mm.)

N.B.:
The tube material (plexiglas) is subject, like all materials, to thermal expansion. Consequently the
value indicated on the tube refers to a tube surrounding temperature of between 20 C. and 25 C.
For values of below 20C, 01mm must be subtracted from the nominal value indicated on the label.
For values higher than 25C, 0.1 mm must be added to the nominal value indicated on the label.

E.g.: If the value indicated on the label is 20.8 mm and the surrounding temperature is higher than 25
C., the reference value becomes 20.9 mm. Taking into account the tolerance of +/- 0.1 mm, we
should expect an indication on the instrument of between 20.9+0. 1=21.Omm and 20.9-0.1=20.8 mm.

Under no circumstances must the temperature of the tube exceed 30C because in
this circumstance the attenuation of the signal does not allow automatic acquisition.
The recommendation is therefore to place the tube on a flat surface without handling
it or holding it back with the fingers for the strict time required for the measurement.

The procedure to be followed is as indicated below:

1) Enter the A-SCAN session (by pressing the A-SCAN key).

2) Cancel all the measurements (by pressing CLEAR twice)
3) Select the amplification GAIN=MED-HIGH
4) Select the aphakic mode MODEAPHAKIC
5) Place a drop of ultrasound gel on the surface of the probe and smooth it out
on the tube.
6) Activate acquisition by pressing the A-SCAN key or footswitch

If the alignment is correct you will obtain an echo of maximum width with the
consequent automatic acquisition of the measurement. If the width of the echo was
not sufficient for "autofreeze, try to set GAIN= HIGH and if possible MAX. Check that
AXL (or AVG in the event of several consecutive measurements) complies with the
tube reference value.
At the end of the test reset MODE and GAIN in the normal way.

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8.9 SHUT DOWN PROCEDURE

NOTE:
If the equipment is not being used for an extended period, the following procedure should be
observed:

1) Depress the "POWER" switch to the "OFF" position to switch off the control
console.
2) Refer to the chapter "Cleaning, sterilisation and maintenance".

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9 CLEANING, STERILISATION AND MAINTENANCE

The medical personnel must take the responsibility to keep existing instruments and
equipment functioning properly. The following simple steps serve as practical
guidelines in establishing your care and maintenance program.

9.1 CLEANING
9.1.1 UNIT

1) Periodically clean the touch screen LCD with soft dusting cloth dampened with
distilled water. If necessary use only neutral detergent.

2) Do not use alcohol, solvents, or abrasives on the control console.

9.1.2 ACCESSORIES

Treat the accessories as indicated above

9.2 STERILISATION
9.2.1 UNIT

The console and footswitch do not need to be sterilised. For cleaning please refer to
the indications given in the relevant instructions for use.

9.3 MAINTENANCE
9.3.1 UNIT

1) The BIOMETER should be stored in a clean and dry environment at room

temperature.

NOTE:
To maintain system safety, the compliance to EN60601-1 leakage current limits should be tested at
least once a year. Please, inquire with the Bioengineering Department in your clinic or with your local
Optikon Distributor/Service Center.

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9.3.2 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 in the appropriate holder after each use. Avoid propping up the
probe on the table: if it falls over the point could be damaged, putting it out of use.
3) Place the protective caps on the probes when not in use for long periods.

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9.3.3 REPLACEMENT OF THE PRINTER PAPER

THE THERMAL PAPER MUST BE INSERTED AFTER

THREADED HOLE FOR FIXING COVER HAVING CUT THE EDGE AS INDICATED
OF HANDLE GRIP FOR PUSHING
THROUGH PAPER
HANDLE FOR PUSHING
THROUGH PAPER
ROLL INSERTED TO PUSH
THROUGH PAPER

THERMAL PAPER

HOUSING FOR THERMAL

PAPER ROLL

THERMAL PRINTER

(LOCATED IN THE UPPER PART OF THE INSTRUMENT COVER)

THERMAL PRINTER (FIG.3)

A red strip on the edge of the print indicates that the roll will soon run out
(approximately 1.5 metres remaining). To load a new roll of thermal paper, follow the
procedure indicated below:

1) Turn off the machine and cut off any excess paper.
2) Remove the panel-paper cutter.
3) Take out the empty roll.
4) Insert one edge of the new roll in the internal slot, as indicated in fig. 3.
5) Switch on the instrument and press the UP arrow key to push the paper
forwards, until it comes out of the upper part. You can also push the paper
through when the instrument is switched off, by rotating the relevant roll (fig.
3).
6) Insert the roll in the appropriate compartment; close the panel-paper cutter,
after having pushed the paper out of the appropriate slot.

NOTE: If the instrument is not being used for a long period of time, it is advisable to pull through a few
centimetres of paper manually prior to use.

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10 TROUBLESHOOTING GUIDE

PROBLEM INTERVENTION
The instrument cannot be switched on (the Push the rear supply connector firmly
green ON light is out) into place.
Check the socket and the rear switch
The screen is too dark or too light and is not Adjust the contrast using the rear blue
legible "LCD" handle
After the autotest the following message Electrostatic discharge or interference
appears: RAM ERROR RECOVERY- DELETE caused by electronic equipment has
ALL DATA IN MEMORY? damaged the memory. Switch off or
move the equipment away; or the
internal battery has run out. See
chapter 2-3
DURING MEASURING...
The instrument does not respond to keyboard 1) The instrument is awaiting inputs
commands relating to a selected field: press
Enter
2) The printer is in operation; wait until
the printing is completed
The instrument is not freezing Make sure that the mode selected is
correct and that the A-scan key has
been pressed to start off the
acquisition
The instrument finds it difficult to freeze During the examination check the
message displayed in the top left of the
screen. Increase or decrease the
GAIN. If GAIN = AUTOSET select
MED/HIGH.
The average axial measurement (large figures) Make sure that you have pressed the
seems unreliable CLEAR key twice prior to the series
of measurements. Check the ACD,
LNS and AL reliability of each
measurement in the memory.

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11 INDEX

A K
ACD ................................................................... 8-5 K1 ...................................................................... 8-5
Anaesthetics ...................................................... 3-1 K2 ...................................................................... 8-5
APHAKIC Parameter ......................................... 8-4
Arrow keys ......................................................... 7-2
A-SCAN Key ...................................................... 7-2
L
A-scan measuring session ................................. 8-1 LCD Contrast ..................................................... 7-3
Autotest Session ................................................ 8-1 Liquid crystal display.......................................... 7-1

B M
Brightness Control ............................................. 7-3 Main switch ........................................................ 7-3
Maintenance ...................................................... 4-2
C MAN.GATE Mode .............................................. 8-4
Microprocessor .................................................. 5-4
CATAR Parameter ............................................. 8-4
Circuit Diagrams ................................................ 5-4
Clear Key ........................................................... 7-1
O
Connector for biometry probe ............................ 7-2 On LED .............................................................. 7-2
Constant A ......................................................... 8-5 Operating parameters ........................................ 8-3
Overheating ....................................................... 3-1
D
D-BASE Key ...................................................... 7-2
Disposal of electrical and electronic equipment . 3-1
P
PC-LINK............................................................. 8-1
E PHAKIC Parameter............................................ 8-4
Piezoelectric effect............................................. 5-4
Electric shock..................................................... 4-2 POINT/ ENTER Key .......................................... 7-2
Electrical warnings ............................................. 3-1 Precautions........................................................ 4-2
EYE Parameter .................................................. 8-3 PRINTKey.......................................................... 7-2
Probe test .......................................................... 8-8
Protective probe caps ........................................ 9-2
F PS.PHAK. Parameter ........................................ 8-4
Footswitch socket .............................................. 7-3
Fuses ................................................................. 3-1 R
Replacement of the printer paper....................... 9-3
G RS232 Connector .............................................. 7-3
GAIN .................................................................. 8-4
S
H SET Key............................................................. 7-2
Holladay Formula ............................................... 8-5 Solvents ............................................................. 3-2
Supply input ....................................................... 7-3
Symbols ............................................................. 4-2
I
Internal lithium battery........................................ 8-6 T
IOL Calculation .................................................. 8-5
IOL Key.............................................................. 7-2 Thermal print...................................................... 3-2
Thermal protection............................................. 3-1

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W Warnings............................................................ 3-1
WB.CATA parameter ......................................... 8-4
Warranty ........................................................... 2-1

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