Related Manuals for Nidek Medical Affinity OT-2200
Summary of Contents for Nidek Medical Affinity OT-2200
- Page 1 Consultation unit OT-2200 For any advice or technical queries, Don’t forget that you can order please do not hesitate to contact our after parts via our online shop sales service on +33 (0)1 49 80 97 97 Instruction Manual...
- Page 2 Manufacturer: NIDEK SA 9, rue Benjamin Franklin 94370 Sucy-en-Brie Tel.: +33 (0)1 49 80 97 97...
- Page 3 Instruction manual | Affinity Read this instruction manual before use or carrying out any maintenance This manual contains the information required to use NIDEK’S Affinity consul- tation unit, such as how to use it, precautions for use, specifications and maintenance instructions. This instruction manual is essential for ensuring the correct use of the unit.
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Page 5: Table Of Contents
Instruction manual | Affinity Contents The Affinity Range –––––––––––––––––––––––––––––––––––––––––––––––––– 6 1.1. Description of the consultation unit –––––––––––––––––––––––––––––– 6 1.2. Introduction to the different versions ––––––––––––––––––––––––––––– 6 Safety Instructions –––––––––––––––––––––––––––––––––––––––––––––––– 8 2.1. Installation precautions ––––––––––––––––––––––––––––––––––––––––– 8 2.2. Electrical connection ––––––––––––––––––––––––––––––––––––––––––– 8 2.3. -
Page 6: The Affinity Range
The Affinity Range 1.1. Description of the consultation unit Affinity is a consultation unit for performing refraction tests. This device eliminates the need for the practitioner and patient to move, by adjusting the position of ophthalmic instruments for them, either manually or electronically. - Page 7 Instruction manual | Affinity Affinity blue • Left-handed • Table top for 2 instruments • Electrically tilting refractor arm • FE-3001 exam chair with reclining back • 1 cabinet for trial lenses and one two- drawer unit • Exam chair with back-and-forth adjustment (motorised option available) Affinity 3 anthracite •...
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Page 8: Safety Instructions
Safety Instructions The safety precautions detailed below must be always be observed. This logo is used to draw attention to a potentially dangerous situation which, if not avoided, CAUTION may result in minor or serious injuries or damage to property. Carefully follow the instructions regarding CAUTION 2.1. -
Page 9: Precautions For Use
Instruction manual | Affinity Do not place heavy objects on the power cable and do not pinch it. The cable cover may become worn, which may result in a fire or an electric shock. If the metal core of the power cable is exposed, if the display unit turns on and off when the power cable is moved (there is a loose connection), or if the cable or plug becomes so hot that it cannot be held, then the power cable is damaged. -
Page 10: Serious Incident Reporting
2.4. Serious incident reporting If you think that a serious incident has occurred in relation to the unit, this incident must be reported to NIDEK SA and the competent authority in the Member State in which you reside. For example, in France this information can be reported via the Agence Nationale de Sécurité... - Page 11 Instruction manual | Affinity 2.6.2 Label The following label and indications are affixed to the unit for the operator’s attention. Manufacturer’s logo Head office address In accordance with Regulation (EU) 2017/745 on medical devices EEE waste(3) is subject to selective waste collection Review the precautions for use and instructions for use Medical device Maximum power...
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Page 12: Description Of The Unit
Unit Description 3.1. Affinity 2 instruments Ambient lighting Éclairage de vision de près Electrically operated refractor arm with tilting option Equipment table: can support 2 instruments plus the refractor. Electrically adjustable height over 18 cm (75 to 93 cm). Connected to an electrically controlled chair, it can accommodate both children and adults. -
Page 13: Instruments
Instruction manual | Affinity 3.2. Affinity 3 instruments Ambient lighting Near vision test lighting Electrically operated refractor arm Equipment table: can support 3 instruments plus the refractor. Remote console Adjustable height over 18 cm (75 to 93 cm). Connected to an electrically controlled chair, it can accommodate both children and adults. -
Page 14: Affinity Rt
3.3. AFFINITY RT Ambient lighting Motorised near vision test Electrically operated refractor arm with tilting option Console table Electrically adjustable height over 18 cm (75 to 93 cm) Exam chair with electrical height adjustment (25 cm adjustment and 200 kg capacity) TAB-DOC-37 | V10 –... -
Page 15: How To Use
Instruction manual | Affinity 4.1. Turning the unit on The unit must first be properly connected to a power source (see § 2.2 ‘Electrical connection’). The thermal circuit breaker (located at the back of the unit) must be switched to position ‘I’: its blue light will turn on and the ‘ALERT’... -
Page 16: Using The Control Panel
4.4. Using the control panel READY : • Solid light: unit is now working • Flashing light: the unit is initialising ALERT : • Light flashing slowly: safety features have been activated ‘READY’ light RT Arm Tilting ‘ALERT’ light ON/OFF Table top Lighting Raise/Lower... -
Page 17: Using The Remote Console (Affinity 3 Only)
Instruction manual | Affinity 4.5. Using the remote console (Affinity 3 only) The Affinity consultation unit has the option of including a manual 3-instrument table. If you choose this option, a second control panel is positioned in the centre of the table. It controls the unit’s main functions: raising/lowering the chair and table, brakes and changing the ambient lighting. -
Page 18: Customising Preferred Height And Ambient Lighting
4.7. Personalising the preferred height and ambient lighting To position the table top at your preferred height and adjust the intensity of the ambient lighting, take the following steps: • Position the table at your preferred working height. When you turn the unit on by pressing the ‘ON/OFF’ button (see button circled in red) or using the initialisation button, the table top will automatically reposition itself to this height. -
Page 19: Using The Near Vision Test
Instruction manual | Affinity 4.8. Using the electronically-powered NV test (optional) The near vision test is a device for remotely performing a Parinaud(4) test on a patient during a refraction exam. This device allows 2 height settings for the test (to be set by the NIDEK technician or the approved distributor) and rotation. -
Page 20: Safety Device
4.9. Safety device 4.9.1. Affinity 2 instruments A safety device, integrated into the instrument table, prevents the patient’s legs from being crushed. In order to prevent crushing on retraction/extension of the table and the electronically-powered RT arm (optional), a force limit is applied to the motors. Sécurité... -
Page 21: Maintenance
Instruction manual | Affinity Maintenance CAUTION Before any maintenance activities are carried out or wearing parts are changed, unplug the electrical power cable (unless otherwise indicated). 5.1. Troubleshooting guide In the event the consultation unit is not working properly, carry out the following checks before calling NIDEK or your approved distributor. -
Page 22: Maintenance And Checks
5.2. Maintenance and checks Check the condition of the consultation unit daily Carry out the following checks: • Control panel (with the naked eye), • Proper functioning of various movements. In the event of any abnormalities, contact NIDEK or your approved distributor. -
Page 23: Specifications And Technical Information
Instruction manual | Affinity Specifications and Technical Information 6.1. CE Classification Rules 1 and 13 of the classification described in Annex VIII of Regulation (EU) 2017/745 on medical devices identify Affinity as a Class I medical device. Protection against electric shocks: as a Class I device, the Affinity consultation unit provides protection against electric shocks. - Page 24 Manufacturer’s declaration - electromagnetic radiation This device is intended to be used in the electromagnetic environment specified below. It is the customer’s or user’s responsibility to ensure that it is used in such an environment. Operation mode(s): Mode N°1: waiting for movementt Mode N°2: continuous movements N.A: not applicable N.I: not implemented...
- Page 25 Instruction manual | Affinity Manufacturer’s declaration - electromagnetic immunity This device is intended to be used in the electromagnetic environment specified below. It is the customer’s or user’s responsibility to ensure that it is used in such an environment. N.A: not applicable N.I: not implemented N.R: not requested Meets...
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Page 26: Technical Specifications
6.3. Technical specifications General specifications Approximate net weight 200 kg (without devices or desk) Electrical supply 230V AC/50 Hz/1500W Electrically adjustable height from 75 to 93 cm with saved preferred height Table top Table maximum load(6): 40 kg per position (2 x 40 = 80 kg for 2 instruments and 3 x 40 = 120 kg for 3 instruments) Refractor on electrically operated and tilting (optional) arm (for 2 instruments only) -
Page 28: Dimensions
6.4. Dimensions 6.4.1. Affinity 6.4.2. Affinity 6.4.3. Affinity RT 2 instruments 3 instruments Single unit Single unit Single unit Affinity 2 instruments Affinity 3 instruments with desk with desk NIDEK SA NIDEK SA Head Office Design and assembly site Écoparc for consultation units 9, rue Benjamin Franklin Multiparc de Parilly...
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