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Summary of Contents for CSO DELUXE2
- Page 1 COSTRUZIONE STRUMENTI OFTALMICI FUTURE Ophthalmic unit INSTRUCTIONS FOR USE DELUXE2 / DELUXE3 COSTRUZIONE STRUMENTI OFTALMICI phone: +39 055 722191 | fax: +39 055 721557 cso@csoitalia.it | www.csoitalia.it IFU318EN01.00 - 02/2022 Colour Inside 1/174...
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Page 3: Table Of Contents
INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 INTRODUCTION ..................3 ......................3 YMBOLS 1.1.1 Device symbols ..................... 4 ................... 5 ENERAL WARNINGS ..................6 ORMATIVE EFERENCES 1.3.1 Community directives ................... 6 1.3.2 Technical standards ....................6 1.3.3 Quality management systems standards ............. 6 ....................... - Page 4 INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 4.11 .................. 33 OW TO RESET THE CHAIR 4.12 ........... 34 OW TO PLACE THE TABLE TOP TO EXAMINE THE PATIENT 4.13 ................34 OW TO TURN OFF THE DEVICE ORDINARY MAINTENANCE ..............35 ...................
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Page 5: Introduction
INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 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
INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 CE Marking (EU Regulation 2017/745) Medical device Waste disposal in compliance with the Directive 2012/19/EU (WEEE), and 2011/65/EU (RoHS II) 1.1.1 DEVICE SYMBOLS Symbol Meaning Type B applied part Fuse This document is the property of C.S.O. SRL. Any reproduction, even partial, it is prohibited. -
Page 7: General Warnings
INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 GENERAL WARNINGS THIS INFORMATION FOR USE REFERS TO OPHTHALMIC UNIT, MODEL FUTURE DELUXE ("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 carefully this information for use. -
Page 8: Normative References
INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 NORMATIVE REFERENCES 1.3.1 COMMUNITY DIRECTIVES Regulation (EU) 2017/745 of the European Parliament and of the Council of 5th April 2017 on medical devices Directive 2012/19/EU on waste electrical and electronic equipment (WEEE) 1.3.2 TECHNICAL STANDARDS IEC 60601-1: 2005 + A1:2012 - Medical electrical equipment - Part... - Page 9 INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 electrical system of the space where the device is installed not in compliance with the technical standards, the laws and regulations in effect in the country of installation of the device direct or indirect consequences or damages to objects or persons, originating from the improper use of the device or erroneous clinical analysis originating from its use The Manufacturer guarantees the device for 24 months after invoicing.
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Page 10: Manufacturer Identification
MANUFACTURER IDENTIFICATION C.S.O. SRL 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 C.S.O. SRL. Any reproduction, even partial, it is prohibited. 8/39... -
Page 11: Safety
INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 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. DANGER Electric shock danger. - Page 12 INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 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.
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Page 13: Device Identification
INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 DEVICE IDENTIFICATION 2.2.1 REGISTRATION DATA IN THE MEDICAL DEVICES REPERTOIRE 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 DEVICE DATA PLATE Fig 1 - Data plate position... -
Page 14: Intended Use
INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 INTENDED USE FUTURE, models DELUXE 2/DELUXE 3, is an ophthalmic unit equipped with the most sophisticated electronic controls that allows for the use of several devices. Through a controlled handling from microprocessor allows the optimal use of the equipment. -
Page 15: Medical Devices Classification
INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 The device must be only used by specialist practitioners and operators (such as optometrists), within the limits of the law and the regulations for the exercise of the profession. 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 16: Medical Electrical Devices Classification
INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 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 IP20 (no protection against liquid Protection degree against humidity infiltration) Sterilization or disinfection method... -
Page 17: Disposal At The End Of The Useful Life
INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 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 18 INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 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.
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Page 19: Manufacturer Declarations
INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 MANUFACTURER DECLARATIONS 2.8.1 ELECTROMAGNETIC EMISSIONS The unit 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 20: Device Description
INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 DEVICE DESCRIPTION SUPPLY DESCRIPTION Fig 5 - Ophthalmic unit – front view This document is the property of C.S.O. SRL. Any reproduction, even partial, it is prohibited. 18/39... - Page 21 INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 Denomination Description LED ceiling light Ceiling light with 3 LED lights with adjustable intensity, spotlight and ambient light. Column Wheel-cover Cover for the table top arm carter Structure There are two backlit keypads and a drawer for the tonometer.
- Page 22 INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 Fig 6– Ophthalmic unit – rear view Denomination Description Projector support Plastic gasket to cover the pole Chair mains power Power cable for the chair is provided socket with the ophthalmic unit Main switch General mains power Power cable is provided with the...
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Page 23: Accessories On Demand
INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 ACCESSORIES ON DEMAND In what follows, are indicated the accessories on demand for the ophthalmic unit: Self-balancing arm for phoropter Auxiliary spot Manual or electrical back/ forward movement of the chair Video camera system Special supports for chin rest LCD monitor arm Drawer and desk... -
Page 24: Keypads
INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 KEYPADS 3.3.1 FUNCTION OF KEYPAD BUTTONS Fig 7 - Structure keypad Function Description CHAIR Movable chair to adjust elevation and back/forward movement (optional) RESET The chair returns to the lower position (this happens also when the unit is turned off) ON/OFF ON/OFF button for ophthalmic unit... -
Page 25: Function Of The Table Keypad Buttons
INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 3.3.2 FUNCTION OF THE TABLE KEYPAD BUTTONS Fig 8 - Table keypad Function Description CHAIR Chair position adjustment Voltage Booster Raises to maximum the light intensity of the Slit Lamp SL regulation Dimming of the Slit Lamp light through semi-circular part touching (only if the function is enabled) Auxiliary device ON/OFF button... -
Page 26: Technical Data
INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 TECHNICAL DATA Technical data Value Supply voltage from 90 V to 264V Power frequency from 47Hz to 63 Hz Network fuses from 4A T 5x20mm to 8AT 5x20mm Auxiliary sockets (chair and from 120Vac 50Hz to 230Vac 60Hz Maximum power absorbed by the 100VA... -
Page 27: Bulk
INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 BULK Fig 9 - FUTURE DELUXE 2 size Never place the heavier device on the external part of the table top. Devices shall be placed on the table top after considering their single weight. - Page 28 INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 Fig 10 - FUTURE DELUXE 3 size Never place the heavier device on the external part of the table top. Devices shall be placed on the table top after considering their single weight.
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Page 29: Device Use
INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 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 30 INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 The device shall be placed considering its weight. One of the devices might not need the sticker pad. 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).
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Page 31: How To Place The Chin Rest
INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 HOW TO PLACE THE CHIN REST The chin rest can be placed on the table top in two different ways, depending on the chosen devices to be installed on the same table top: using a support for adjusting chin rest: when moving the table top, the chin rest will be placed in front of the device to be used for... - Page 32 INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 For the unit version with opening on the left, there is a specific attachment for the fixation point cable connection. Make sure the chin rest is properly aligned with accessories on the table top. Move the table top in front of the chair until activating the locking system of the table top.
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Page 33: How To Place Devices On The Table Top
INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 HOW TO PLACE DEVICES ON THE TABLE TOP Place the device on the table top and align the cogged wheels on the cogged guides. Fasten the two wheel cover carters to the cogged wheels on the table top. -
Page 34: How To Place Electric Cables
INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 HOW TO PLACE ELECTRIC CABLES Fig 17– Ophthalmic unit – rear view Chair mains power socket Main switch General mains power socket Auxiliary socket CAUTION Danger of stumbling and falling. Do not let the power cables or the connection cables free in a place where people could walk. -
Page 35: How To Turn On The Ophthalmic Unit
INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 HOW TO TURN ON THE OPHTHALMIC UNIT CAUTION Danger of keypad damages. The protective film of the keypad has to be removed when the ophthalmic unit is off. Removing the film while the ophthalmic unit is ON might damage the keypad. Remove the protective film from the keypad. - Page 36 INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 4.12 HOW TO PLACE THE TABLE TOP TO EXAMINE THE PATIENT Inform the patient to take a seat. Place the table top in front of the patient. Press the button < or > to shift the plane and place the device in front of the patient.
- Page 37 INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 ORDINARY MAINTENANCE SAFETY WARNINGS DANGER Electric shock danger. Unplug the power cable from the mains socket before disinfecting or cleaning the ophthalmic unit and before any maintenance operation. It is forbidden to carry out any maintenance operation on the ophthalmic unit that is not recalled in the information for use.
- Page 38 INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 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. Pull out the fuse drawer.
- Page 39 Electronic tab 610540-HK4020 Bearing for rotation 4109010 Decelerator 100818130 Main control panel 100818330 Table control panel 100819550 CSO ceiling light 300502320 Moving motor 330801050 Leg protection micro switch 3020690 Switching 100818821V Table top 10081834V Upper table top for two devices...
- Page 40 INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 TROUBLESHOOTING Issue Cause Solution Note Verify the connection Power cable not Connect the between the connected to the power cable of ophthalmic unit The ON/OFF power supply unit. the unit to the and the mains button on the The keypad-circuit...
- Page 41 INSTRUCTIONS FOR USE FUTURE | IFU318EN01.00 - 02/2022 Issue Cause Solution Note Check that the table top is levelled off. Check that the steel cable anchored to Install the table The movable the tie-rod is well top properly. table top does The table top is not tightened.
- Page 44 4/174 COSTRUZIONE STRUMENTI OFTALMICI phone: +39 055 722191 | fax: +39 055 721557 cso@csoitalia.it | www.csoitalia.it FUTURE | IFU318EN01.00 - 02/2022...
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