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Related Manuals for OPTIKON BIOLINE
Summary of Contents for OPTIKON BIOLINE
- Page 1 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:sales@optikon.com - www.optikon.com...
- Page 2 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.
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Page 3: Table Of Contents
TABLE OF CONTENTS Page DISCLAIMER................1-1 LIMITED WARRANTY CONDITIONS ........2-1 WARNINGS................3-1 SYMBOLS ..................4-1 GENERAL INFORMATION ............5-1 SYSTEM DESCRIPTION ....................5-1 TECHNICAL SPECIFICATIONS ..................5-2 CIRCUIT DIAGRAMS ....................... 5-5 INSTALLATION ................6-1 INTRODUCTION ......................6-1 UNPACKING AND INSPECTION..................6-1 INSTALLATION PROCEDURE ..................6-1 EQUIPMENT OPERATION ............7-1 EQUIPMENT LAYOUT ..................... - Page 4 THIS PAGE IS INTENTIONALLY BLANK...
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Page 5: Disclaimer
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. - Page 6 BIOLINE Manual for installation and use OPTIKON 2000 THIS PAGE IS INTENTIONALLY BLANK Code 141002EN 26.10.05 Rev.0...
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Page 7: Limited Warranty Conditions
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. - Page 8 BIOLINE Manual for installation and use OPTIKON 2000 THIS PAGE IS INTENTIONALLY BLANK Code 141002EN 26.10.05 Rev.0...
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Page 9: Warnings
), 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. - Page 10 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.
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Page 11: Symbols
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. - Page 12 BIOLINE Manual for installation and use OPTIKON 2000 THIS PAGE IS INTENTIONALLY BLANK Code 141002EN 26.10.05 Rev.0...
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Page 13: General Information
(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. -
Page 14: Technical Specifications
BIOLINE Manual for installation and use OPTIKON 2000 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: .... - Page 15 BIOLINE Manual for installation and use OPTIKON 2000 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.
- Page 16 BIOLINE Manual for installation and use OPTIKON 2000 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 ±...
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Page 17: Circuit Diagrams
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. - Page 18 BIOLINE Manual for installation and use OPTIKON 2000 THIS PAGE IS INTENTIONALLY BLANK Code 141002EN 26.10.05 Rev.0...
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Page 19: Installation
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. - Page 20 BIOLINE Manual for installation and use OPTIKON 2000 THIS PAGE IS INTENTIONALLY BLANK Code 141002EN 26.10.05 Rev.0...
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Page 21: Equipment Operation
BIOLINE Manual for installation and use OPTIKON 2000 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. - Page 22 BIOLINE Manual for installation and use OPTIKON 2000 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.
- Page 23 BIOLINE Manual for installation and use OPTIKON 2000 REAR PANEL (FIG.2) 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).
- Page 24 BIOLINE Manual for installation and use OPTIKON 2000 THIS PAGE IS INTENTIONALLY BLANK Code 141002EN 26.10.05 Rev.0...
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Page 25: Operation
BIOLINE Manual for installation and use OPTIKON 2000 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 •... -
Page 26: A-Scan Key Functions
BIOLINE Manual for installation and use OPTIKON 2000 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. -
Page 27: Setting Up The A-Scan Examination
BIOLINE Manual for installation and use OPTIKON 2000 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. - Page 28 BIOLINE Manual for installation and use OPTIKON 2000 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.
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Page 29: Iol Calculation Session
BIOLINE Manual for installation and use OPTIKON 2000 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. -
Page 30: Function Of The Keys In The Iol Calculation
BIOLINE Manual for installation and use OPTIKON 2000 NOTE: THE MEMORY OF THE LENSES THE RELATING CONSTANTS AND THE SETTING OF THE 3.6 V SUPPLIED BY AN INTERNAL OLT 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... - Page 31 BIOLINE Manual for installation and use OPTIKON 2000 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.
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Page 32: Probe Test
BIOLINE Manual for installation and use OPTIKON 2000 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.) -
Page 33: Shut Down Procedure
BIOLINE Manual for installation and use OPTIKON 2000 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. - Page 34 BIOLINE Manual for installation and use OPTIKON 2000 THIS PAGE IS INTENTIONALLY BLANK Code 141002EN 8-10 26.10.05 Rev.0...
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Page 35: Cleaning, Sterilisation And Maintenance
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. Code 141002EN 26.10.05 Rev.0... -
Page 36: Accessories
BIOLINE Manual for installation and use OPTIKON 2000 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. -
Page 37: Replacement Of The Printer Paper
BIOLINE Manual for installation and use OPTIKON 2000 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... - Page 38 BIOLINE Manual for installation and use OPTIKON 2000 THIS PAGE IS INTENTIONALLY BLANK Code 141002EN 26.10.05 Rev.0...
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Page 39: Troubleshooting Guide
BIOLINE Manual for installation and use OPTIKON 2000 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... - Page 40 BIOLINE Manual for installation and use OPTIKON 2000 THIS PAGE IS INTENTIONALLY BLANK Code 141002EN 10-2 26.10.05 Rev.0...
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Page 41: Index
BIOLINE Manual for installation and use OPTIKON 2000 11 INDEX 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 A-scan measuring session ......... 8-1 LCD Contrast ............. 7-3 Autotest Session .......... - Page 42 BIOLINE Manual for installation and use OPTIKON 2000 Warnings............3-1 WB.CATA parameter ......... 8-4 Warranty ............2-1 Code 141002EN 11-2 26.10.05 Rev.0...