CSO POLARIS Instructions For Use Manual

Advanced analysis of the tear film

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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
IT
1/174

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  • 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...
  • 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...
  • 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...
  • 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...
  • 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...
  • 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...
  • 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...
  • 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...
  • 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...
  • 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...
  • 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...
  • 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...
  • 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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