OPTIKON BIOLINE User manual

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. [phone] - Fax. [phone]
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
1DISCLAIMER..............................................................................1-1
2LIMITED WARRANTY CONDITIONS ........................................2-1
3WARNINGS................................................................................3-1
4SYMBOLS ..................................................................................4-1
5GENERAL INFORMATION ........................................................5-1
5.1 SYSTEM DESCRIPTION ................................................................................................. 5-1
5.2 TECHNICAL SPECIFICATIONS ...................................................................................... 5-2
5.3 CIRCUIT DIAGRAMS ....................................................................................................... 5-5
6INSTALLATION ..........................................................................6-1
6.1 INTRODUCTION .............................................................................................................. 6-1
6.2 UNPACKING AND INSPECTION..................................................................................... 6-1
6.3 INSTALLATION PROCEDURE ........................................................................................ 6-1
7EQUIPMENT OPERATION ........................................................7-1
7.1 EQUIPMENT LAYOUT ..................................................................................................... 7-1
8OPERATION ..............................................................................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
9CLEANING, 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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BIOLINE Manual for installation and use
OPTIKON 2000
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 [phone]
Fax. [phone]
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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BIOLINE Manual for installation and use
OPTIKON 2000
• 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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