ANUFACTURER DECLARATIONS 2.8.1 Electromagnetic emissions ................. 18 DEVICE DESCRIPTION ................22 ..................22 ROVISION DESCRIPTION 3.1.1 Accessory device Polaris ..................24 3.1.2 Tools kit ......................25 ....................26 ECHNICAL DATA DEVICE USE ..................... 27 ................27 OW TO INSTALL THE DEVICE ................
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POLARIS | IFU312EN00 ................... 43 AFETY WARNINGS ..................... 43 EVICE CLEANING ..............44 PARE PARTS AND ACCESSORIES LIST ..................44 ROUBLESHOOTING This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 2/44...
Read the instructions for use General mandatory action sign Note. Useful information for the user General prohibition sign Manufacturer CE Marking (Directive 93/42/EEC) This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 3/44...
Class II equipment GENERAL WARNINGS THESE INSTRUCTIONS FOR USE REFER TO THE ACCESSORY DEVICE POLARIS ("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.
1.3.3 QUALITY MANAGEMENT SYSTEMS STANDARDS UNI CEI EN ISO 13845:2016 - Medical devices. Quality management systems - Requirements for regulatory purposes This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 5/44...
Manufacturer damages caused by service lack or inefficiency, originating by causes or circumstances out of the Manufacturers control This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 6/44...
CSO S.r.l. Costruzione Strumenti Oftalmici Via degli Stagnacci, 12/E 50018 - Scandicci (FI) - ITALY phone: +39-055-722191 - fax +39-055-721557 cso@csoitalia.it www.csoitalia.it This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 7/44...
CAUTION Electric shock risk. Do not touch the power supply cables with wet hands. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 8/44...
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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. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 9/44...
Fig 2 - Device data plate INTENDED USE POLARIS is a device for the advanced analysis of the tear film. Itallows to estimate the quality and quantity of the tear film. Through non- invasive break up time test (NIBUT) it is possible to analyze its stability and regularity.
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The following picture shows an example of interferometric images. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 11/44...
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The device can be used in combination with a PC and the application software Phoenix. System minimum requirements This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 12/44...
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IEC 60601-1:2005 + A1:2102 - "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance". This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 13/44...
MEDICAL DEVICES CLASSIFICATION Technical data Value Classification in compliance with the attached IX to the Directive 93/42/EEC Class I and successive modifications This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 14/44...
-10°C +55°C Atmospheric pressure 700 hPa 1060 hPa Relative humidity Temperature +10°C +35°C Atmospheric pressure 800 hPa 1060 hPa Relative humidity This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 15/44...
The user has to consider the effects potentially dangerous for the environment and the human health originating from an improper disposal of the whole device or its parts. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 16/44...
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Strict sanctions for transgressors are provided for by law. For specific information about the disposal in other countries than Italy, contact the local Dealer. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 17/44...
IEC 61000-3-3 power supply net as there is in the housing units. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 18/44...
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(50/60Hz) 3 A/m magnetic fields should be that of 3 A/m magnetic fields. a typical commercial or hospital IEC 61000-4-8 environment. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 19/44...
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Interference may occur in the vicinity of equipment marked with the following symbol: This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 20/44...
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At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 21/44...
INSTRUCTIONS FOR USE POLARIS | IFU312EN00 DEVICE DESCRIPTION PROVISION DESCRIPTION Fig 4 - Provision description This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 22/44...
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Power supply USB optional Device case For the list of accessories and available models contact the Manufacturer or the local Distributor. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 23/44...
INSTRUCTIONS FOR USE POLARIS | IFU312EN00 3.1.1 ACCESSORY DEVICE POLARIS Fig 5 - Device Polaris Description Observation hole ON/OFF button USB power connector Lighting head Movable arm Fixed arm Lamp clamping nut Slit Lamp mount This document is the property of CSO Costruzione Strumenti Oftalmici srl.
Placido's disk allows to evaluate the tear film break distortion or irregularity. Fig 6 - Fine grid Fig 7 - Placido's disk Fig 8 - Negative grid This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 25/44...
Light source White LED light Dimensions (Height x Length x Depth) 217 x 22 x 74.5 mm Weight 300 g Alignment Manual This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 26/44...
90° angle. Remove the lid on the slit lamp arm seat. Fig 9 - Slit lamp lighting head displacement This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 27/44...
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POLARIS | IFU312EN00 Place the lamp mount in the slit lamp arm seat. Fig 10 - How to place the device This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 28/44...
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Turn the device clamp nut to block it to the slit lamp. Fig 11 - Blocking the device with the clamp nut This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 29/44...
How to connect the device to the PC USB port. Fig 12 - How to connect the device to the PC This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 30/44...
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How to connect the device to the external power supply USB port. Fig 13 - How to connect the device to the external power supply This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 31/44...
Collect and attach always the power supply cables. It is forbidden to use any extension cable not authorized by the manufacturer. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 32/44...
Turn on the Slit Lamp. deactivate the lighting system of the Slit Lamp. Refer to the Slit Lamp instructions for the turning ON/OFF. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 33/44...
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. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 34/44...
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Fig 17 - Patient position on the chin rest Lift or lower the chin cup as needed. Fig 18 - Knob rotation Fig 19 - Chin cup placement This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 35/44...
Fig 20 - Eyepleces adjustment for the operator ametropia correction Fig 21 - How to adjust the upper arm. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 36/44...
You will observe a black line near the convex part of the meniscus profil, it is typical of the normal tear meniscus. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 37/44...
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Fig 25 - Black line on an abnormal tear meniscus Fig 26 - Abnormal tear meniscus profile This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 38/44...
Fig 27 - Regular tear film Fig 28 - Irregular tear film This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 39/44...
Closer rings correspond to areas of steeper curved cornea, while more distance between rings correspond to flatter cornea area. Fig 29 - Placido's disk reflection This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 40/44...
Rotate the device clamp nut. Lift the device from its seat in the slit lamp arm and place it in the device case. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 41/44...
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INSTRUCTIONS FOR USE POLARIS | IFU312EN00 Fig 31 - Clamp nut rotation This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 42/44...
Clean the external parts of the device using a damp non-abrasive cloth to avoid damaging the material. CAUTION Danger of material damages. Do not use solvents or diluent to clean the device. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 43/44...
Replace the device not generate any Technical Service PC does not work or power cable. light Center. is disconnected. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 44/44...
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