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Summary of Contents for OPTIKON I.V.
- Page 1 Code 181004EN 2007-10-09 Rev. 0 EQUIPMENT CART WITH ELECTRIC I.V. POLE INSTALLATION AND OPERATING MANUAL OPTIKON 2000 S.p.A. Via del Casale di Settebagni 13 - 00138 Rome – Italy Tel. +39 06 88884355 – Fax +39 06 8888440 e-mail: sales@optikon.com...
- Page 2 OPTIKON 2000 S.p.A. is an ISO 9001 and ISO 13485 certified company that manufactures surgical and diagnostic devices for ophthalmology. All OPTIKON 2000 products are manufactured in compliance with the requirements of Directive 93/42/EEC on medical devices.
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Page 3: Table Of Contents
TABLE OF CONTENTS DISCLAIMER ......................1-1 LIMITED WARRANTY CONDITIONS ..............2-1 WARNINGS......................3-1 SYMBOLS........................ 4-1 GENERAL INFORMATION..................5-1 SYSTEM DESCRIPTION ........................5-1 CONTROLS AND INDICATORS....................... 5-1 TECHNICAL SPECIFICATIONS ....................... 5-3 CIRCUIT DIAGRAMS ........................5-4 INSTALLATION AND OPERATING PROCEDURE..........6-1 INTRODUCTION ..........................6-1 INITIAL INSPECTION ........................ - Page 4 THIS PAGE HAS BEEN INTENTIONALLY LEFT BLANK...
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Page 5: Disclaimer
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. Optikon 2000 S.p.A. is not responsible for any clinical problem resulting from mishandling this equipment and makes no medical recommendations. - Page 6 I.V. Pole cart Installation and operating manual OPTIKON 2000 THIS PAGE HAS BEEN INTENTIONALLY LEFT BLANK Code 181004EN 2007-10-09 Rev. 0...
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Page 7: Limited Warranty Conditions
OPTIKON S.p.A. technical service. OPTIKON 2000 S.p.A. reserves the right to verify, in case of failures, if the instrument and/or its accessories have been modified or tampered with in any way, or if they have been damaged by improper use. - Page 8 I.V. Pole cart Installation and operating manual OPTIKON 2000 THIS PAGE HAS BEEN INTENTIONALLY LEFT BLANK Code 181004EN 2007-10-09 Rev. 0...
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Page 9: Warnings
USE OF THE SYSTEM SHOULD BE RESTRICTED TO QUALIFIED MEDICAL PERSONNEL. • 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. •... - Page 10 LABELING OF THE CART). • TO AVOID POSSIBLE ELECTRIC SHOCK TO THE PATIENT DUE TO EXCESSIVE LEAKAGE CURRENT INSUFFICIENT DIELECTRIC STRENGTH, PLUG TO THE CART COMPATIBLE OPTIKON EQUIPMENT ONLY (SEE COMPATIBILITY CHART TECHNICAL SPECIFICATIONS). • DO NOT DISPOSE OF THE TROLLEY AS UNSORTED MUNICIPAL WASTE.
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Page 11: Symbols
I.V. Pole cart Installation and operating manual OPTIKON 2000 4. SYMBOLS The following symbols are often used on medical equipment, with the function of delivering information and warnings in a limited space. The user should become acquainted to these symbols before using the equipment. - Page 12 I.V. Pole cart Installation and operating manual OPTIKON 2000 THIS PAGE HAS BEEN INTENTIONALLY LEFT BLANK Code 181004EN 2007-10-09 Rev. 0...
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Page 13: General Information
5. GENERAL INFORMATION SYSTEM DESCRIPTION The Optikon equipment cart 181004 has been designed to host the Optikon surgical systems console and to move them conveniently in the Operating Room area. It is also provided with a mayo tray mounted on a swing arm for sustaining the surgical instruments connected to the console during the setup and the surgical procedure. - Page 14 This protection cover, located at the rear of the cart, was designed to prevent the use of the cart's power outlets to connect any device other than approved Optikon instruments. The lid must be removed by a qualified technician when the console is first installed. The lid must be restored in place once the equipment has been installed.
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Page 15: Technical Specifications
I.V. Pole cart Installation and operating manual OPTIKON 2000 TECHNICAL SPECIFICATIONS SPECIFICATIONS PARAMETER Manufacturer:....... OPTIKON 2000 S.p.A. Via del Casale di Settebagni 13 00138 Roma - Italia Model ........... I.V. Pole cart Regulatory conformity: ....93/42/EEC Directive on medical devices Technical standards ..... -
Page 16: Circuit Diagrams
. 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 17: Installation And Operating Procedure
INITIAL INSPECTION This instrument was carefully inspected, mechanically and electrically, prior to shipment. Before unpacking the OPTIKON Equipment Cart, inspect the carton for damage. If it is damaged, be especially careful when inspecting the contents for any mechanical damage which may have occurred during shipment, and test the electrical performance. If physical damage is found, you should apply at once to the carrier that handled the consignment (mail, railways or forwarding agents) and have an appropriate certificate established. -
Page 18: Installation
Lock the arm into place by manually tightening the knob at the top of the extension. b. Place the Optikon Console on the equipment tray. c. Remove the protection cover from the electric sockets by unscrewing the 4 socket-head screws. Removing the protection cover will give you access to the mains sockets (Fig. -
Page 19: Shutdown Procedure
Switch on the equipment and the cart, then proceed according to the hosted equipment user manual. SHUTDOWN PROCEDURE If the Optikon cart is not being used for an extended period, the following procedure should be observed: Set the pole to the minimum height. - Page 20 I.V. Pole cart Installation and operating manual OPTIKON 2000 NOTE: OPTIKON 2000 S.p.A. reserves the right to change design and specifications without notice because of its policy of continuous product research and development. CAUTION DO NOT USE SYNTHETIC DETERGENTS OR OIL-BASED SOAPS.
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Page 21: Troubleshooting Guide
The TROUBLE-SHOOTING GUIDE lists some malfunctions which may occur, the symptoms and the corrective actions. If the system remains inoperative even after performing the corrective actions indicated below, contact OPTIKON 2000 S.p.A. sales/service department. SYMPTOMS CORRECTIVE ACTION Mains power supply System completely inoperative A.C.