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CSO ETOILE II Instructions For Use Manual

Ophthalmic unit
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COSTRUZIONE STRUMENTI OFTALMICI
ETOILE II
Ophthalmic unit
INSTRUCTIONS FOR USE
COSTRUZIONE STRUMENTI OFTALMICI
phone: +39 055 722191 | fax: +39 055 721557
cso@csoitalia.it | www.csoitalia.it
IFU316EN01.00 - 02/2022
EN
1/174

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  • Page 1 COSTRUZIONE STRUMENTI OFTALMICI ETOILE II Ophthalmic unit INSTRUCTIONS FOR USE COSTRUZIONE STRUMENTI OFTALMICI phone: +39 055 722191 | fax: +39 055 721557 cso@csoitalia.it | www.csoitalia.it IFU316EN01.00 - 02/2022 1/174...

  • Page 3: Table Of Contents

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 INTRODUCTION ..................3 ......................3 YMBOLS 1.1.1 Device symbols ..................... 4 ................... 4 ENERAL WARNINGS ..................5 ORMATIVE EFERENCES 1.3.1 Community directives ................... 5 1.3.2 Technical standards ....................5 1.3.3 Quality management systems standards ............. 5 .......................
  • Page 4 INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 4.8.1 Functions setting ....................39 4.8.2 Setting the slit lamp light intensity ..............40 4.8.3 Adjusting the spotlight intensity ................. 41 4.8.4 Setting buttons AUX1 and AUX2 ................ 42 ................ 42...

  • Page 5: Introduction

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 INTRODUCTION The device is the result of a long research period, conducted by experts to give the product technical innovation, quality and design. Ophthalmic units are characterized by their practicality compatible with a wide range of devices for the modern ophthalmological diagnostic.

  • Page 6: Device Symbols

    Fuse GENERAL WARNINGS THESE INSTRUCTIONS FOR USE REFER TO THE OPHTHALMIC UNIT MODEL ETOILE II ("OPHTHALMIC UNIT" FROM NOW ON). THE ORIGINAL TEXT IS IN ITALIAN. Before using the ophthalmic unit or if you don't use it since a long time, read these instructions carefully.

  • Page 7: Normative References

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 Before using the ophthalmic unit, check that there is no sign of damages due to transport or an incorrect storage, that could compromise the correct functioning of the ophthalmic unit. It is forbidden to reproduce, totally or partially, texts or images contained in these instructions for use without the written authorization of the Manufacturer.

  • Page 8: Warranty

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 WARRANTY The Manufacturer is responsible for the device conformity to the Regulation (EU) 2017/745 of April 5th 2017 for: features safety and reliability CE marking The Manufacturer refuses any responsibility for:...

  • Page 9: Manufacturer Identification

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 The warranty does not cover: repairs of faults originating from natural disasters, mechanical shocks (fall, hit, etc), electrical system faults, negligence, improper use, maintenance or reparations carried out with non-original materials...

  • Page 10: Safety

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 SAFETY SAFETY WARNINGS DANGER Electric shock danger. Do not let water fall on any part of the device. Do not immerse any part of the device into the water or other liquids.
  • Page 11 INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 CAUTION Electric shock risk. Do not leave the power supply cables in contact with sharp corners or objects. Always collect and fasten the power supply cables. CAUTION If you notice a wired odour or smoke coming out of the device or if it emanates heat, turn it off immediately.

  • Page 12: Device Identification

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 DEVICE IDENTIFICATION 2.2.1 REGISTRATION DATA IN THE MEDICAL DEVICES LIST The device registration data can be verified on the Italian Ministry of Health website at this page: Ministero della Salute - Ricerca dispositivi 2.2.2...

  • Page 13: Intended Use

    ETOILE II | IFU316EN01.00 - 02/2022 INTENDED USE The ETOILE II ophthalmic unit is a working station which allows to place three devices on the rotating table top. Thanks to the table top rotation, you can easily and efficiently pass from one device to the other.

  • Page 14: Medical Devices Classification

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 Patient area: any volume in which a patient with applied parts can intentionally or unintentionally come into contact with other electro- medical devices or electro-medical systems or with foreign masses and masses or with other people in contact with these elements.

  • Page 15: Medical Electrical Devices Classification

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 MEDICAL ELECTRICAL DEVICES CLASSIFICATION Classification complying with the standard EN 60601-1:2005 + A1:2012 Technical data Value Type of protection against the direct Class I and indirect contacts Applied parts Type B...

  • Page 16: Disposal At The End Of The Useful Life

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 DISPOSAL AT THE END OF THE USEFUL LIFE Instruction for the correct disposal of the device according to European Directive 2012/19/EU, and 2011/65/EU about the reduction of use of dangerous substances in the electrical and electronic equipment, as well as waste disposal.
  • Page 17 INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 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.

  • Page 18: Manufacturer Declarations

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 MANUFACTURER DECLARATIONS 2.8.1 ELECTROMAGNETIC EMISSIONS The device is designed to be used in a room with the following electromagnetic characteristics: The copy of the documentation of the electromagnetic compatibility (EMC) can be demanded at any time to C.S.O. Costruzione Strumenti Oftalmici SRL.

  • Page 19: Device Description

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 DEVICE DESCRIPTION SUPPLY DESCRIPTION Fig 4 - Supply description This document is the property of C.S.O. SRL. Any reproduction, even partial, it is prohibited. 17/55...
  • Page 20 INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 Denomination Description ETOILE II ophthalmic unit The unit is composed of 3 table tops. Each table top allows to install one medical device. On the table top there is a second electronic tab protected by a dome.
  • Page 21 ETOILE II | IFU316EN01.00 - 02/2022 If requested, the ophthalmic unit can be personalised with the following accessories: ETOILE II ophthalmic unit, version with table top opening on the left accessories for placing the device on the table top chair with electrical elevation...

  • Page 22: Etoile Ii Ophthalmic Unit

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 3.1.1 ETOILE II OPHTHALMIC UNIT Fig 5 - ETOILE II ophthalmic unit Description Projector and spotlight support Adjustable LED spotlight Column Arm with rotating table top in three positions Structure base...
  • Page 23 INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 Fig 6 - Table top for devices Description Outlet for device Outlet for device (120V or 230V depending on the model) Keypad for the regulation of the slit lamp placed on the table top...
  • Page 24 INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 Fig 7 - Electrical connections Description Fuse drawer ON/OFF button Auxiliary joints Power supply outlet for ophthalmic unit Auxiliary power supply outlet Power supply outlet for chair This document is the property of C.S.O. SRL.

  • Page 25: Command Keypad On The Structure

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 3.1.2 COMMAND KEYPAD ON THE STRUCTURE Fig 8 - Keypad Function Description POWER ON/OFF button for ophthalmic unit TABLE Buttons for adjusting table top elevation (only for compatible ophthalmic units) CHAIR Buttons for adjusting chair elevation RET.

  • Page 26: Keypad Placed On The Table Top Arm

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 3.1.3 KEYPAD PLACED ON THE TABLE TOP ARM Fig 9 - Keypad Function Description HOLD Button for blocking the table top TABLE Buttons for adjusting table top elevation (only for compatible ophthalmic units)

  • Page 27: Chin Rest (Optional)

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 CHIN REST (OPTIONAL) 3.1.5 Fig 11 - Chin rest Description Chin rest support. Handle Chin cup adjustment knob Chin cup Forehead rest Chin rest structure The support (A) can be different depending on the table top where the chin rest will be installed.

  • Page 28: Chair (Optional)

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 CHAIR (OPTIONAL) 3.1.6 Different chair models are available accordingly to the client's choice. The base with telescopic column allows to adjust the elevation of the chair. It is possible to adjust elevation and position directly from the unit keypad, depending on the model.

  • Page 29: Accessories For Placing The Device (Optional)

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 ACCESSORIES FOR PLACING THE DEVICE (OPTIONAL) Fig 13 - Table top accessories Description Table top front edge Left cogged guide Sticker pad (for right/left alignment of the device) Scrolling plate Lower inserts for chin rest fixing...

  • Page 30: Technical Data

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 TECHNICAL DATA Version 230V Version 120V Technical data Supply voltage 230 Vac ±10% 120 Vac ±10% Power frequency 50 Hz 60 Hz Network fuses 4A T 5x20 mm 8A T 5x20 mm...

  • Page 31: Ophthalmic Unit Bulk

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 OPHTHALMIC UNIT BULK Fig 14 - ETOILE II ophthalmic unit bulk (*) Electrical elevation of the handicap table top (**) Electrical elevation of the table (***) No elevation for the table top This document is the property of C.S.O.

  • Page 32: Device Use

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 DEVICE USE HOW TO INSTALL THE OPHTHALMIC UNIT For the ophthalmic unit installation procedure refer to the service manual. The installation has to be carried out by expert and competent personnel. The installation must be only carried out by expert authorised personnel.
  • Page 33 INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 Place the sticker pad between the two cogged wheels and the scrolling plate on the table top. Verify the position respectively to the central axis (A). Fig 15 - Placing the sticker pad on the table top This document is the property of C.S.O.

  • Page 34: How To Place The Chin Rest

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 HOW TO PLACE THE CHIN REST On each table top, install chin rests depending on the position chosen for the devices. Place the chin rest support under the table top. Fasten screws (B) to the table top.

  • Page 35: How To Place Devices On The Table Top

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 HOW TO PLACE DEVICES ON THE TABLE TOP Do not place devices weighing more than 20 Kg on each single table top. The Slit Lamp shall be placed in line with the outlet (A) on the table top (B).
  • Page 36 INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 Place the device on the table top and align the cogged wheels on the cogged guides. Lock the two protection carters to the cogged wheels on the table top. Fig 21 - Placement of the device...

  • Page 37: How To Connect The Ophthalmic Unit

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 HOW TO CONNECT THE OPHTHALMIC UNIT Fig 24 - Connecting the ophthalmic unit Denomination Power cable for connecting the ophthalmic unit to the power supply Auxiliary power cable for connecting the ophthalmic unit to a device or an external accessory Power cable for connecting the ophthalmic unit to the chair.

  • Page 38: How To Turn On The Ophthalmic Unit

    Press the CHAIR button (B) to adjust chair elevation. Adjust table top elevation by pressing the TABLE button (C) on the arm keypad (Only for ETOILE II ophthalmic unit with table top elevation). Adjust the spotlight intensity (D).
  • Page 39 INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 Fig 26 - Keypad on the arm of the table top Press the ON/OFF button (B) on the table top keypad to turn on the devices placed on the table tops.

  • Page 40: How To Reset The Chair

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 HOW TO RESET THE CHAIR Chair settings can be reset by using the structure keypad or the arm keypad on the table top. Structure keypad Simultaneously press the chair adjustment buttons placed on the structure keypad.

  • Page 41: How To Set Functions

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 HOW TO SET FUNCTIONS 4.8.1 FUNCTIONS SETTING Press the POWER button (A) on the structure keypad to turn on the ophthalmic unit. Set the desired functions (e.g. AUX1, power instrument, light).

  • Page 42: Setting The Slit Lamp Light Intensity

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 4.8.2 SETTING THE SLIT LAMP LIGHT INTENSITY Press the POWER button (A) to turn on the ophthalmic unit. Press the POWER INSTRUMENT button (E) on the arm keypad to turn on the table top.

  • Page 43: Adjusting The Spotlight Intensity

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 4.8.3 ADJUSTING THE SPOTLIGHT INTENSITY Press the POWER button (A) to turn on the ophthalmic unit. Press the LIGHT button (C) to turn on the spotlight. Press + (B) and - (D) buttons to adjust the spotlight intensity.

  • Page 44: Setting Buttons Aux1 And Aux2

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 4.8.4 SETTING BUTTONS AUX1 AND AUX2 AUX1 and AUX2 buttons can have double or single function according to the settings programmed during the installation stage. Furthermore, the AUX2 button simultaneously commands another...

  • Page 45: How To Use The Oft And Ret Buttons

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 4.10 HOW TO USE THE OFT AND RET BUTTONS The OFT and RET buttons are connected to the 2V and 6V auxiliary ports. To use these ports, connect the cable provided with the device to the jumper2 on the tab.

  • Page 46: How To Place The Table Top To Examine The Patient

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 4.11 HOW TO PLACE THE TABLE TOP TO EXAMINE THE PATIENT Inform the patient to take a seat. Manually place the arm and the table top in front of the patient.

  • Page 47: How To Place The Table Top To Examine Mobility Impaired Patients

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 Check the patient’s height respectively to the chin rest. Press the chair height adjustment button on the command keypad. Perform the check-up with the medical device. Refer to the device user manual and, if needed, the software user manual to perform medical investigations.

  • Page 48: How To Turn Off The Device

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 4.12 HOW TO TURN OFF THE DEVICE CAUTION Do not turn off the unit and do not disconnect the connection cable when it is in use. Before turning off the ophthalmic unit, make sure the devices presenting an integrated operating system that needs to be turned off, if present, have been turned off.

  • Page 49: How To Use The Ophthalmic Unit In The Event Of Electrical Failure

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 4.13 HOW TO USE THE OPHTHALMIC UNIT IN THE EVENT OF ELECTRICAL FAILURE The ophthalmic unit is provided with a system that allows for continuing tests even in the event of a circuit board failure. To restore the proper functioning of the ophthalmic unit, the electronic tab needs to be replaced.

  • Page 50: How To Move And Disassemble The Ophthalmic Unit

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 4.14 HOW TO MOVE AND DISASSEMBLE THE OPHTHALMIC UNIT For the disassembly procedure refer to the installation manual. For the ophthalmic unit disassembly procedure refer to the service manual. The procedure has to be carried out by expert and competent personnel.
  • Page 51 Components weight operators Counterweight 8x8x38 37.4 Base 70x76x68 Structure 74x34x61 80x85x45 45.6 Column 8x8x130 ETOILE II with electrical elevation for the table top Size Weight 170x160x190 174 Kg Components Number of Size (cm) Components weight operators Counterweight 8x8x38 18.7 Motor...

  • Page 52: Ordinary Maintenance

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 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 53: Network Fuses Replacement

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 NETWORK FUSES REPLACEMENT CAUTION Danger of material damages. The fuses have to be replaced only when the power cable is disconnected from the mains power. For any other kind of fault please contact the installation company.

  • Page 54: Spare Parts And Accessories List

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 SPARE PARTS AND ACCESSORIES LIST To order spare parts or accessories, provide the product code as indicated in the list. If not included in the list, contact the Manufacturer or the local Distributor.

  • Page 55: Troubleshooting

    INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 The conical bearing for arm rotation, code 610435-32007, must be ordered together with the rotation locking bracket, code 100813153. TROUBLESHOOTING Issue Cause Solution Note Connect the power Verify the connection cable of the unit to...
  • Page 56 INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 Issue Cause Solution Note The unit turns The diode Check the diode off when the bridge (D1) is bridge is functioning If the problem persists, different damaged or (input 12V alternate replace the tab.
  • Page 57 INSTRUCTIONS FOR USE ETOILE II | IFU316EN01.00 - 02/2022 Issue Cause Solution Note Check that the cables are connected properly. Check Connection the output voltage for each cables are not peripheral device that is not The spotlight or connected working.
  • Page 60 4/174 COSTRUZIONE STRUMENTI OFTALMICI phone: +39 055 722191 | fax: +39 055 721557 cso@csoitalia.it | www.csoitalia.it ETOILE II | IFU316EN01.00 - 02/2022...

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