Table of Contents
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Table of Contents
Related Manuals for Essilor Instruments Retina 550
Summary of Contents for Essilor Instruments Retina 550
- Page 1 User manual www.essilor-instruments.com...
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Page 2: Table Of Contents
> C SER MANUAL ONTENTS ONTENTS I. I NTRODUCTION 1. Symbols a. Device symbols 2. General warnings 3. Normative references a. Community directives b. Technical standards c. Quality management systems standards 4. Warranty 5. Manufacturer identification II. S AFETY 1. Safety warnings 2. -
Page 3: Introduction
I. I NTRODUCTION... -
Page 4: Symbols
> I. I SER MANUAL NTRODUCTION The complete user manual is available on a web space. To access, please scan the QR code below using a dedicated application. Le manuel utilisateur complet est disponible sur un espace web. Pour y accéder veuillez scanner le QR code ci-dessous à... -
Page 5: Device Symbols
> I. I SER MANUAL NTRODUCTION a. Device symbols Symbol Meaning Applied part of type B Class II device 2. G ENERAL WARNINGS These instructions refer to the model Retina550 ("Device" from now on). The original manual is in italian. This device is compliant with marking. -
Page 6: Quality Management Systems Standards
> I. I SER MANUAL NTRODUCTION c. Quality management systems standards • ISO 9001:2008 Quality management systems - Requirements. • ISO 13845:2012 Medical devices. Quality management systems - Requirements for regulatory purposes. 4. W ARRANTY The manufacturer is responsible for the device conformity to the Community directive 93/42/EEC as amended by the 2007/47/EC for: •... -
Page 7: Manufacturer Identification
> I. I SER MANUAL NTRODUCTION 5. M ANUFACTURER IDENTIFICATION ESSILOR INTERNATIONAL Instruments Division 147 rue de Paris 94220 Charenton le Pont FRANCE Retina550 - Fundus camera > V1 - 06-2017... -
Page 8: Safety
II. S AFETY... -
Page 9: Safety Warnings
> II. S SER MANUAL AFETY 1. S AFETY WARNINGS Electric shock danger. Do not let water fall on the device. Do not immerse the device in water or other liquids. Electric shock danger. If the power cables are damaged they must be replaced to prevent any risk. -
Page 10: Intended Use
> II. S SER MANUAL AFETY Power suppliers data plate 3. I NTENDED USE The device Retina550 is a medical electrical device for the non-mydriatic fundus camera. The device has been designed for the screening, the acquisition and the elaboration of an image of the retina in the ophthalmic procedure. -
Page 11: Medical Devices Classification
> II. S SER MANUAL AFETY Read the instructions for use of the software. The PC must be compliant to the norm IEC 60950-1 Information technology equipment - Safety - Part 1: General requirements. If the PC is installed in the patient area it is necessary to install an isolation electrical supply compliant with the directive IEC 60601-1 and 3.1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. -
Page 12: Medical Electrical Devices Classification
> II. S SER MANUAL AFETY 5. M EDICAL ELECTRICAL DEVICES CLASSIFICATION Classification in compliance with the technical specification EN 60601- 1 (3rd edition). Technical data Value Type of protection against the direct and indirect Class II contacts Applied parts Type B IPX0 (no protection against liquid or solid Protection degree against humidity... -
Page 13: Disposal At The End The Useful Life
> II. S SER MANUAL AFETY 7. D ISPOSAL AT THE END THE USEFUL LIFE Instruction for disposal of product correctly according to European Directive 2012/19/EU, and 2011/65/EU about the reduction of use of dangerous substances in the electrical and electronic equipments, and waste disposal. -
Page 14: Manufacturer Declarations
> II. S SER MANUAL AFETY 8. M ANUFACTURER DECLARATIONS a. Electromagnetic emissions The device is designed to be used in a room with the following electromagnetic characteristics: Emission test Compliance Electromagnetic environment The device uses radio frequency energy only for its inner functioning. - Page 15 > II. S SER MANUAL AFETY Immunity test IEC 60601-1-2 test level Compliance Electromagnetic environment Floors should be wood, concrete or ceramic tile. If the floors are Electrostatic discharge 8kV contact 2/4/8/15 kV IEC 60601- 1-2 covered with synthetic material Test level IEC 61000-4-2 the relative humidity should be at...
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Page 16: Device Description
III. D EVICE DESCRIPTION... -
Page 17: Provision Description
> III. D SER MANUAL EVICE DESCRIPTION 1. P ROVISION DESCRIPTION With: No. Denomination Description Chinrest (optional) Adjustable height, adjustable distance between chin and forehead. Protection carter Protection against accidental hand crushing. Power supplier Composed by a camera unit equipped with microcamera for the image Device Retina550 acquisition an a firewire cable compatible with the device. -
Page 18: Device Retina550
> III. D SER MANUAL EVICE DESCRIPTION a. Device Retina550 1. Device Retina550 2. Joystick 3. Device blocking knob 4. Cogged wheels 5. Shooting channel 6. Device power cable 7. Power IN 8. USB connection cable between device and PC b. -
Page 19: Electric Table (Optional)
> III. D SER MANUAL EVICE DESCRIPTION d. Electric table (optional) The electric table can be provided in different models. The electric table is composed by a support surface on which the cogged guides are built. One or two telescopic columns, motorized, allow to adjust the height of the support plane. -
Page 20: Device Use
IV. D EVICE USE... -
Page 21: How To Install The Device
> IV. D SER MANUAL EVICE USE 1. H OW TO INSTALL THE DEVICE Danger of device fall. The electric table must be installed on a horizontal and stable surface. Place the electric table in the room. The electric table must be lifted by two people. If present, block the table wheels. - Page 22 > IV. D SER MANUAL EVICE USE Block the two protection carters to the cogged wheels on the support plane. Chinrest installation. Under the support plane, there are two screws to block the chinrest support to the support plane. Electrical connection between the several components. Retina550 - Fundus camera >...
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Page 23: How To Connect The Device
> IV. D SER MANUAL EVICE USE 2. H OW TO CONNECT THE DEVICE With: Denomination USB connection cable between device and PC. Power cable for the connection between the power supplier and the device. Power cable for the connection of the electric table with the power supply. Power cable for the connection of the electric table with the power supply. -
Page 24: How To Turn On The Device
> IV. D SER MANUAL EVICE USE 3. H OW TO TURN ON THE DEVICE Turn on the PC. Push the activation switch of the power supply on "ON". Launch the program. > Wait that the main screen of the software is shown. Click on "NEW PATIENT"... -
Page 25: How To Adjust The Chinrest
> IV. D SER MANUAL EVICE USE 4. H OW TO ADJUST THE CHINREST Tell the patient to take a seat. Ask the patient to put the chin on the chin cup and the forehead against the forehead rest. Verify if the eyes position is correct respectively to the shooting channel. To adjust the height of the eyes you need to lift or lower the chin cup. -
Page 26: How To Acquire The Image
> IV. D SER MANUAL EVICE USE Lift or lower the chin cup as needed. Unscrew the knob. 5. H OW TO ACQUIRE THE IMAGE Move the joystick and place the device with the shooting channel at 5 cm distance from the patient's eye. Move towards the eye with the tool. - Page 27 > IV. D SER MANUAL EVICE USE Bring the image into focus. Act on the roller on the upper part of the joystick. Refer to the graphic indicator to focus the image. Push down the joystick to confirm and acquire the image. The image will be saved in the gallery. Refer to the software instructions for the image managing in the database.
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Page 28: How To Change The Paper For Chin Cup
> IV. D SER MANUAL EVICE USE 6. H OW TO CHANGE THE PAPER FOR CHIN CUP The chin cup paper must be changed for every patient. This device is provided with a package of paper for chin cup. When you use the last paper change the package. -
Page 29: Ordinary Maintenance
V. O RDINARY MAINTENANCE... -
Page 30: Safety Warnings
> V. O SER MANUAL RDINARY MAINTENANCE 1. S AFETY WARNINGS Electric shock danger. Unplug the power cable from the mains socket before disinfecting the device and before any maintenance operation. The device does not contain any piece that requires the user's intervention. Do not dismantle any part of the device. - Page 31 Essilor International 147, rue de Paris – 94220 Charenton-le-Pont France www.essilor.com...
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