Summary of Contents for S4Optik Antares
- Page 1 ANTARES Corneal topographer INSTRUCTIONS FOR USE S4OPTIK, LLC 250 Cooper Ave., Suite 100 Tonawanda, NY, 14150 +1-888-224-6012 +1 800 313 8696 info@s4optik.com 0051 1/174...
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Page 3: Table Of Contents
ISPOSAL AT THE END THE USEFUL LIFE ..............ANUFACTURER DECLARATIONS ................2.8.1 Electromagnetic emissions ................. 21 DEVICE DESCRIPTION ..............24 ROVISION DESCRIPTION ..................3.1.1 Device ANTARES ....................26 3.1.2 Power supply ...................... 27 3.1.3 Chin rest ......................28 3.1.4 Electric table (optional) ..................29 ECHNICAL DATA ....................... - Page 4 INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 PARE PARTS AND ACCESSORIES LIST ..................ROUBLESHOOTING ........................This document is the property of S4Optik. Any reproduction, even partial, it is prohibited. 2/48...
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Page 5: Introduction
INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 INTRODUCTION The device is the result of a long research period, conducted by experts to give the product technical innovation, quality and design. The device can be easily used thanks to the guided manual capture and the electronic control of all the functions of the device. -
Page 6: Device Symbols
Type B applied part Class II equipment GENERAL WARNINGS THESE INSTRUCTIONS FOR USE REFER TO THE DEVICE ANTARES ("DEVICE" FROM NOW ON). THE ORIGINAL TEXT IS IN ITALIAN. Before using the device or if you don't use it since a long time, read these instructions carefully. -
Page 7: Normative References
INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 It is forbidden to reproduce, totally or partially, texts or images contained in these instructions for use without the written authorization of the Manufacturer. The Manufacturer reserves himself the right to modify the contents of the instructions for use, without notice. -
Page 8: Warranty
INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 WARRANTY The Manufacturer is responsible for the device conformity to the Community directive 93/42/EEC as amended by the 2007/47/EC for: features safety and reliability CE marking The Manufacturer refuses any responsibility for: installation and activation not activated in conformity to the... -
Page 9: Manufacturer Identification
INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 - the parts subject to usage and/or deterioration originating from the normal use and those that might be broken because of an improper use or maintenance carried out by personnel non- authorized by the Manufacturer. -
Page 10: Safety
INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 SAFETY SAFETY WARNINGS DANGER Electric shock danger. Do not let water fall on the device. Do not immerse the device in water or other liquids. DANGER Electric shock danger. If the power cables are damaged they must be replaced in an Authorized Service Center to prevent any risk. - Page 11 INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 CAUTION Electric shock risk. Do not touch the power supply cables with wet hands. CAUTION Electric shock risk. Do not leave the power supply cables in contact with sharp corners or objects. Collect and attach always the power supply cables.
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Page 12: Device Identification
INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 The device does not generate and does not receive any electromagnetic interference if it is placed near other electrical appliances. No preventive or corrective actions are required. DEVICE IDENTIFICATION 2.2.1 REGISTRATION DATA IN THE MEDICAL DEVICES LIST... -
Page 13: Power Supply Data Plate
POWER SUPPLY DATA PLATE Fig 3 - Power supply PSP2402 data plate INTENDED USE ANTARES Corneal topographer is an electro-medical device used to perform the corneal topography and for the diagnostic of the lacrimal dysfunction. The device has been designed for the capture and the elaboration of an image of the cornea in the ophthalmic procedure. - Page 14 INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 The device provides information on the curvature, the elevation and the refractive power, and a great number of concise parameters for the diagnostic and the follow-up of the corneal surface. Corneal topography The device provides information on elevation, curvature and dioptric power of the anterior corneal surfaces over a diameter of 10 mm.
- Page 15 INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 Meibography The device allows to analyze the Meibomian glands in a non-invasive method. The miebography is performed through the infrared illumination which enhance the contrast, magnifying the anatomic structure of the glands without causing any discomfort to the patient.
- Page 16 INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 Advanced editing system of the rings which allows to modify the position of the edges in order to provide a proper reconstruction even on distorted surfaces. Availability of the following maps: sagittal curvature map, tangential curvature map, elevation, refractive power, Gaussian curvature map, corneal thickness.
- Page 17 INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 Peripheral degrees Pupil decentralization, pupil diameter, and corneal diameter size Keratorefractive indices calculated in the pupil area for an evaluation of the patient's visual quality Keratoconus screening index for diagnosis and follow-up The device must be used only by practitioners, within the limits of the law and the regulations for the exercise of the profession.
- Page 18 INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 The accessories must be compliant to the norm IEC 60950-1 Information technology equipment - Safety - Part 1: General requirements. If the accessories are installed in the patient area it is necessary to install an isolation electrical supply compliant with the directive IEC 60601-1:2005 + A1:2102 - "Medical electrical equipment - Part 1:...
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Page 19: Medical Devices Classification
INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 MEDICAL DEVICES CLASSIFICATION Technical data Value Classification in compliance with the attached IX to the Directive 93/42/EEC Class Im and subsequent modifications MEDICAL ELECTRICAL DEVICES CLASSIFICATION Classification in compliance with the technical specification EN 60601-... -
Page 20: Environmental Conditions
INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 ENVIRONMENTAL CONDITIONS Phase Technical data Transport Temperature -40°C +70°C Atmospheric pressure 500 hPa 1060 hPa Relative humidity Storage Temperature -10°C +55°C Atmospheric pressure 700 hPa 1060 hPa Relative humidity Temperature +10°C +35°C Atmospheric pressure... -
Page 21: Disposal At The End The Useful Life
INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 DISPOSAL 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 22 INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 in the event that a new device is purchased from the same Manufacturer to replace an old one placed on the market before 13 August 2005, equivalent and with the same functions of the new device, the Distributor or Manufacturer are legally required to collect the old device.
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Page 23: Manufacturer Declarations
INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 MANUFACTURER DECLARATIONS 2.8.1 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. The radio Radio frequency emission. - Page 24 INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 IEC 60601-1-2 Conformity Immunity test Electromagnetic environment test level level Floors should be wood, concrete or ceramic tile. If the floors are Electrostatic ±6 kV contact. ±6 kV contact. discharge. IEC ±8 kV air covered with synthetic material ±8 kV air...
- Page 25 INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 Conformity IEC 60601-1-2 Immunity test Electromagnetic environment test level level 3 Vrms from 150 kHz to RF conduced IEC 80 MHz 61000-4-6 3 Vrms 3 V/m RF conduced IEC 3 V/m from 80 MHz to 61000-4-3 2.5 GHz...
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Page 26: Device Description
INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 DEVICE DESCRIPTION PROVISION DESCRIPTION Fig 5 - Provision description This document is the property of S4Optik. Any reproduction, even partial, it is prohibited. 24/48... - Page 27 INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 Denomination Description Chin rest Adjustable height Adjustable distance between chin and forehead Protection carter Protection against accidental hand crushing. Power supply Device ANTARES Composed by a camera unit equipped with one or several micro video cameras for capturing the images.
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Page 28: Device Antares
INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 3.1.1 DEVICE ANTARES Fig 6 - Device ANTARES Description Device ANTARES Joystick Device blocking knob Cogged wheels USB connection cable between device and computer Power supply connector Device power supply cable Shooting channel This document is the property of S4Optik. -
Page 29: Power Supply
INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 3.1.2 POWER SUPPLY Fig 7 - Power supply Description Data plate Power supply Power ON control light ON/OFF switch Power supply out connector Power supply mains connector Power supply cable Device power supply cable This document is the property of S4Optik. -
Page 30: Chin Rest
INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 3.1.3 CHIN REST Fig 8 - Chin rest Description Chin rest support Handle Knob Chin cup Forehead rest Chin rest structure This document is the property of S4Optik. Any reproduction, even partial, it is prohibited. -
Page 31: Electric Table (Optional)
INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 3.1.4 ELECTRIC TABLE (OPTIONAL) Different table models are available accordingly to the client's choice. The electric table is composed by a support surface on which are installed the cogged guides for the device housing. The table has one or two telescopic columns, motorized, that allow to adjust the height of the support plane. - Page 32 INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 Technical data Value Minimum height of the chin cup from 24 cm the working plan Base movement (x, y, z) 105 x 110 x 30 mm Working distance 74 mm Light sources Technical data...
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Page 33: Device Use
INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 DEVICE USE HOW TO INSTALL THE DEVICE CAUTION 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. - Page 34 INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 Fig 13 - How to place the device Fig 14 - Protection carters placement Install the chin rest. Under the support plane, there are two screws to block the chin rest support to the support plane.
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Page 35: How To Connect The Device
INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 HOW TO CONNECT THE DEVICE Fig 16 - Device connection This document is the property of S4Optik. Any reproduction, even partial, it is prohibited. 33/48... - Page 36 INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 Denomination USB connection cable between device and PC 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...
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Page 37: How To Place The Electric Cables
INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 HOW TO PLACE THE ELECTRIC CABLES CAUTION Danger of device fall. Do not leave free cables which can represent an obstacle or a danger for the patient or the operator. CAUTION Danger of stumbling and falling. Do not let the power cord or the connection cables free in a place where people could walk. -
Page 38: How To Turn On The Device
INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 The power socket is on the column of the electric table, below, and it has to be used for the connection with the mains power. One of the power sockets on the column of the electric table, on top, is dedicated to the device power supply. -
Page 39: Adjust The Chin Rest
INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 ADJUST THE CHIN REST 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 the correct eyes position respectively to the shooting channel. - Page 40 INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 Lift or lower the chin cup as needed. Fig 20 - Knob rotation Fig 21 - Chin cup placement This document is the property of S4Optik. Any reproduction, even partial, it is prohibited. 38/48...
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Page 41: How To Capture The Image
INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 HOW TO CAPTURE THE IMAGE Turn the joystick and align the device with the patient's eye. Move towards the eye with the tool. Keep centered the reflection of the corneal vertex. Push the button on the joystick. Perform some micro movements back and forward with the joystick and keep the best image alignment. - Page 42 INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 Refer to the application software instructions for the image managing in the database. This document is the property of S4Optik. Any reproduction, even partial, it is prohibited. 40/48...
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Page 43: How To Change The Paper For Chin Cup
INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 HOW TO CHANGE THE PAPER FOR CHIN CUP At the end of each exam remove the paper for chin cup in order to always have a new and hygienic one for the next patient. -
Page 44: How To Turn Off The Device
INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 HOW TO TURN OFF THE DEVICE CAUTION Do not turn off the computer and do not disconnect the connection cable between the computer and the device when the program is in use. Immobilize the device. Turn the locking knob. -
Page 45: Ordinary Maintenance
INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 ORDINARY MAINTENANCE SAFETY WARNINGS DANGER Electric shock danger. Unplug the power cable from the mains socket before disinfecting the device and before any maintenance operation. CAUTION The device does not contain any piece that requires the user's intervention. - Page 46 INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 SPARE PARTS AND ACCESSORIES LIST Code Description 30010071D3F Power supply cable Isolation transformer 230V/230V. Power supply cable 10101300 800 VA (maximum charge) 4014020 Package of paper for chin cup (50 pieces) 4013090 Protective cover...
- Page 47 INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 TROUBLESHOOTING Inconvenient Cause Solution Note If the device is powered trough the auxiliary power Connect the power supply of the table, Power cable not cable of the device The device does check the connected with the...
- Page 48 INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 Inconvenient Cause Solution Note The connection Unplug and plug in cable between again the device and PC does connection cable not work properly. between device and The installation of The anti virus The application PC.
- Page 49 INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 Inconvenient Cause Solution Note Check that the Connection cable keyboard with the PC connection cable disconnected. properly fit in USB From the control The keyboard of Keyboard switch in port. Switch the panel of the PC, the PC does not position OFF.
- Page 50 INSTRUCTIONS FOR USE ANTARES | IFUANTARESEN00 Inconvenient Cause Solution Note The tear film is not Ask the patient to Poor image quality well distributed on close and open the from Placido's disk the cornea surface eyes. (dry eye) Presence of dust of...
- Page 52 4/174 S4OPTIK, LLC 250 Cooper Ave., Suite 100 Tonawanda, NY 14150 +1-888-224-6012 +1 800 313 8696 info@s4optik.com ANTARES | IFUANTARESEN00 - 07/2018...