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Related Manuals for Topcon COMPU VISION CV-5000
Summary of Contents for Topcon COMPU VISION CV-5000
- Page 1 CV-5000 INSTRUCTION MANUAL COMPU VISION CV-5000...
- Page 2 Instruksjonshåndbøker på offisielle virallisilla kielillä olevat käyttöohjeet språk i EUs land er tilgjengelige på [fi] [no] ovat saatavilla seuraavalla verkko- følgende nettsted: sivustolla: Τα εγχειρίδια οδηγιών στις επίσημες γλώσσες των κρατών μελών της [el] Ευρωπαϊκής Ένωσης διατίθενται στον ακόλουθο δικτυακό τόπο: https://global.topcon.com/Manuals_IFUs/...
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Page 3: Introduction
INTRODUCTION Thank you for purchasing the TOPCON COMPU VISION CV-5000. INTENDED USE / INDICATIONS FOR USE This instrument is used to measure the refractive power of the eye and to test binocular functionality. CLINICAL BENEFITS Target all patient's eyes to be determined for prescription value. - Page 4 2. The contents of this manual are correct to the best of our knowledge. Please inform us of any ambiguous or erroneous descriptions, missing information, etc. 3. This manual is translation of the original instructions.This manual was originally written in English. ©2014 TOPCON CORPORATION ALL RIGHTS RESERVED...
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Page 5: Table Of Contents
CONTENTS INTRODUCTION ....................... 1 DISPLAY AND SYMBOLS FOR SAFE USE ..............5 GENERAL SAFETY INFORMATION ................7 DISCLAIMERS ........................9 WARNING DISPLAYS AND POSITIONS ............... 10 1.BEFORE USE 1.1 CHECKING THE ACCESSORIES ..................12 STANDARD ACCESSORIES ..................12 OPTIONAL ACCESSORIES ..................13 PRODUCTS SOLD SEPARATELY ................ - Page 6 OPERATING PRINCIPLE ..................21 DISPOSAL ......................... 22 PATIENT’S ENVIRONMENT ..................23 ELECTROMAGNETIC COMPATIBILITY ..............24 REQUIREMENT TO THE EXTERNAL CONNECTION DEVICES ......28 IT NETWORK ENVIRONMENT ................. 28 SPECIFICATIONS OF PERSONAL COMPUTER (COMMERCIAL PRODUCT) TO BE CONNECTED ....................29 6.OPERATING AND USAGE METHOD Usage method ......................
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Page 7: Display And Symbols For Safe Use
DISPLAY AND SYMBOLS FOR SAFE USE To encourage safe and proper use and to prevent danger to the operator and others or potential damage to property, important cautionary messages are placed on the instrument body and inserted in the manual. We suggest that everyone using the instrument understand the meaning of the following displays, icons and text before reading the "SAFETY CAUTIONS"... - Page 8 Symbol Description Authorised Representative in the European Community Authorised Representative (Responsible Person) in the United Kingdom. Medical Devices Unique Device Identification (UDI) Humidity limitation Atmospheric pressure limitation Temperature limit Keep away from sunlight Fragile, handle with care Keep dry This way up Maximum number of identical packages which may be stacked on one another.
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Page 9: General Safety Information
GENERAL SAFETY INFORMATION WARNING Ensuring the Safety of Patients and Operators Be careful not to bump the patient's eyes or nose with the instrument during operation. The patient may be injured. Preventing Electric Shocks and Fires. To avoid fire and electric shock, install the instrument in a place free of water and other liquids. To avoid fire and electric shock, do not put cups or other containers with liquids near the instru- ment. - Page 10 CAUTION Ensuring the Safety of Patients and Operators When moving the instrument body up and down, be careful not to bump it against the patient's face. The patient may be injured. This instrument should only be used by skilled operators. To prevent the instrument from tipping over or falling and to avoid injury, do not install the instrument on an uneven, unsteady or sloping surface.
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Page 11: Disclaimers
TOPCON is not responsible for any damage caused by unauthorized access from out- side, malware or viruses. Diagnoses made shall be the responsibility of the user and TOPCON shall not take any responsibility for the results of such diagnoses. -
Page 12: Warning Displays And Positions
To ensure safety, the machine provides warning displays. Use the instrument correctly by observing the display instructions. If any of the following display labels are missing, contact your TOPCON dealer or your local Topcon office listed on the back cover of this manual. - Page 13 In case of combination of PC operation. Label Meaning WARNING Electoric shock may cause bums or a possible fire. Turn the power switch OFF and unplug the power cord before replacing the fuses. Replace only with fuses of the correct rating. WARNING To avoid injury caused by electric shock, do not open the cover.
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Page 14: Before Use
BEFORE USE 1.1 CHECKING THE ACCESSORIES Install the devices (RM, CL and others), which will be connected with CAUTION the optional accessories, out of the CV-5000 patient's environment. STANDARD ACCESSORIES Upon unpacking, make sure that all the following standard accessories are included. Figures in ( ) are the quantities. -
Page 15: Optional Accessories
Power cord (1) 1Dial Controller connection cable (1) The shape is different according to the destination. Measuring head connection cable (1) Install CD (1)* Depending on the destination, this is not attached. For combination of KB-50S or mouse operation only. For combination of PC operation only. -
Page 16: Products Sold Separately
• POWER SUPPLY UNIT for CV-5000 (BUILT-IN PC TYPE) (for combination of KB-50S or mouse operation) • POWER SUPPLY UNIT for CV-5000 (PC EXTERNAL TYPE) (for combination of PC operation) * The PC and Mouse are commercial products. For usable external devices and connection cables, please contact your local distributor or contact address on the back cover. -
Page 17: Maintenance
MAINTENANCE USER MAINTENANCE ITEMS Item Inspection time Contents • Inspection Before using The instrument must operate correctly. • The examination window and corneal align- ing window must be free of stain or flaw. • Cleaning When the part is Examination window and corneal aligning stained window •... -
Page 18: Appendices
APPENDICES 3.1 SHAPE OF PLUG Country Voltage/frequency Shape of plug Mexico 110V/50Hz Type C&E Argentina 220V/60Hz Type A Peru 220V/60Hz Type A Venezuela 110V/50Hz Type C&E Bolivia & Type A (Most common) 220V/60Hz Paraguay Type H (Infrequently) Chile 220V/60Hz Type A Colombia 110V/50Hz Type C... - Page 19 Country Voltage/frequency Type of plug Italy 230V/50Hz Type C / F / L Latvia 230V/50Hz Type C / F Lithuania 230V/50Hz Type C / F Luxembourg 230V/50Hz Type C / F Malta 230V/50Hz Type G Netherlands 230V/50Hz Type C / F Poland 230V/50Hz Type C / E...
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Page 20: Specifications And Performance
SPECIFICATIONS AND PERFORMANCE MEASURING HEAD Measuring range +27.00 to -27.00D Spherical power Measuring step 0.25D/1.00D/2.00D/3.00D Measuring range +8.00 to -8.00D Cylinder power Measuring step 0.25D/1.00D Measuring range 0 to 180° Cylinder axis Measuring step 1°/5°/15° Measuring range 0 to 20 (all direction) Prism Measuring step 0.1 ... -
Page 21: General Information On Usage And Maintenance
GENERAL INFORMATION ON USAGE AND MAINTENANCE INTENDED PATIENT POPULATION • The patient who undergoes an examination by this instrument must maintain concentration for a few minutes and keep to the following instructions: To fix the face to the forehead rest. To understand and follow instructions when undergoing an examination. -
Page 22: Electric Rating
(4) Do not store the instrument where chemicals are stored or gas is generated. 5. Usage period 8 years from delivery providing regular maintenance is performed (according to the self- certification [Topcon data]) ELECTRIC RATING Power supply voltage : AC100-240V, 50-60Hz... -
Page 23: System Classification
SYSTEM CLASSIFICATION Types of protection against electric shocks: This instrument is classified as Class I equipment. Class I equipment does not depend only on basic insulation for protection against electric shocks, but also provides a means of connection to a protective earth system of facilities so that metal parts that come into contact do not become conductive while the basic insulation is in failure. -
Page 24: Disposal
• Contact your dealer or Topcon European Representative (if you are in EU members). This symbol is applicable for EU member countries only. To avoid potential negative consequences for the environment and possibly human... -
Page 25: Patient's Environment
PATIENT’S ENVIRONMENT When the patient or operator may touch the devices (including the connected devices) or when the patient or operator may touch the person contacting the devices (including the connecting devices), the patient's environment is shown below. In the patient's environment, use the device conforming to IEC60601-1. If you are compelled to use any device not conforming to IEC60601-1, use an insulation transformer. -
Page 26: Electromagnetic Compatibility
ELECTROMAGNETIC COMPATIBILITY This product conforms to the EMC standard IEC 60601-1-2:2014(Ed.4.0). The expected electromagnetic environment for the whole life cycle is home medical treatment environment. a ) MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the ACCOM- PANYING DOCUMENTS. - Page 27 Guidance and manufacturer's declaration - electromagnetic emissions The CV-5000 is intended for use in the electromagnetic environment specified below. The cus- tomer or the user of the CV-5000 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance The CV-5000 uses RF energy only for its internal func-...
- Page 28 Guidance and manufacturer's declaration - electromagnetic immunity The CV-5000 is intended for use in the electromagnetic environment specified below. The cus- tomer or the user of the CV-5000 should assure that it is used in such an environment. IEC 60601 Electromagnetic Immunity test Compliance level...
- Page 29 Guidance and manufacturer's declaration - electromagnetic immunity The CV-5000 is intended for use in the electromagnetic environment specified below. The cus- tomer or the user of the CV-5000 should assure that it is used in such an environment. Immunity IEC 60601 Compliance Electromagnetic environment - test...
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Page 30: Requirement To The External Connection Devices
Those who connect the additional device to the signal input/output units should make a medi- cal system and therefore take total responsibility to obey the requirements of IEC60601-1 about their system. If someone has a question, he/she must contact the TOPCON authorized dealer or TOPCON office at the address on the back cover. -
Page 31: Specifications Of Personal Computer (Commercial Product) To Be Connected
Output of measured data, patient information and device information. (LAN) CV-5000 RM/KR-1 RM/KR-800 (LAN) CL-300 Output of measured data, patient information. SPECIFICATIONS OF PERSONAL COMPUTER (COMMERCIAL PRODUCT) TO BE CONNECTED • When you connect this instrument on the personal computer con- nected to a network, ensure security properly in order to prevent the infection with computer virus, leak of information and other troubles. -
Page 32: Operating And Usage Method
OPERATING AND USAGE METHOD Usage method With KB-50S or a commercially available mouse and monitor connected Connect the main unit, POWER SUPPLY UNIT for CV-5000 (BUILT-IN PC TYPE), KB- 50S or a commercially available mouse and monitor. Connect the power supply cord to a commercial power source. Adjust the instrument distance between the patient's pupils and the distance between instrument's pupils. - Page 33 Measure the distance from the corneal vertex to the main unit. Operate the PC and use each lens installed within the main unit to conduct a subjective refraction test. After use, turn OFF the PC power supply switch. After use, turn OFF the POWER SUPPLY UNIT for CV-5000 (PC EXTERNAL TYPE) switch and remove the instrument from the power source.
- Page 35 Period of use: Please inform us of the date of purchase. Defective condition: Please provide us with as much detail as possible on the problem. COMPU VISION CV-5000 INSTRUCTION MANUAL Revision 1 Date of issue 2023-2-10 Published by TOPCON CORPORATION...
- Page 36 COMPU VISION CV-5000 1056516-01-B...
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