Related Manuals for CSO POLARIS
Summary of Contents for CSO POLARIS
- Page 1 COSTRUZIONE STRUMENTI OFTALMICI POLARIS Advanced analysis of the tear lm INSTRUCTIONS FOR USE COSTRUZIONE STRUMENTI OFTALMICI phone: +39 055 722191 | fax: +39 055 721557 cso@csoitalia.it | www.csoitalia.it 1/174...
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Page 3: Table Of Contents
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 ................ - Page 4 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...
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Page 5: Introduction
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... -
Page 6: Device Symbols
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. -
Page 7: Normative References
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... -
Page 8: Warranty
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... -
Page 9: Manufacturer Identification
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... -
Page 10: Safety
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... - Page 11 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...
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Page 12: Device Identification
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. - Page 13 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...
- Page 14 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...
- Page 15 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...
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Page 16: Medical Devices Classification
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... -
Page 17: Medical Electrical Devices Classification
-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... -
Page 18: Disposal At The End The Useful Life
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... - Page 19 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...
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Page 20: Manufacturer Declarations
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... - Page 21 (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...
- Page 22 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...
- Page 23 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...
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Page 24: Device Description
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... - Page 25 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...
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Page 26: Accessory Device Polaris
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. -
Page 27: Tools Kit
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... -
Page 28: Technical Data
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... -
Page 29: Device Use
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... - Page 30 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...
- Page 31 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...
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Page 32: How To Connect The Device
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... - Page 33 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...
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Page 34: How To Place The Electric Cables
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... -
Page 35: How To Insert The Film In The Device Lighting Head
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... -
Page 36: Adjust The Chin Rest
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... - Page 37 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...
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Page 38: How To Visualize The Image
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... -
Page 39: How To Analyze The Lipid Film
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... - Page 40 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...
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Page 41: How To Analyze The Tear Film Stability And Regularity
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... -
Page 42: How To Analyze The Corneal Surface Regularity
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... -
Page 43: How To Capture The Image
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... - Page 44 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...
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Page 45: Ordinary Maintenance
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... -
Page 46: Spare Parts And Accessories List
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... - Page 48 4/174 COSTRUZIONE STRUMENTI OFTALMICI phone: +39 055 722191 | fax: +39 055 721557 cso@csoitalia.it | www.csoitalia.it POLARIS | IFU312EN00 - 09/2018...
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