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CSO Cobra+ Instructions For Use Manual

Non-mydriatic fundus camera
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COSTRUZIONE STRUMENTI OFTALMICI
Non-mydriatic Fundus camera
INSTRUCTIONS FOR USE
Cobra+
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
COBRA+IFUENGCSO0104032024
0051
ENG

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  • Page 1 COSTRUZIONE STRUMENTI OFTALMICI Non-mydriatic Fundus camera INSTRUCTIONS FOR USE Cobra+ 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 COBRA+IFUENGCSO0104032024 0051...

  • Page 3: Table Of Contents

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 INTRODUCTION ..................5 ......................5 YMBOLS 1.1.1 Device symbols ..................... 6 ................... 6 ENERAL WARNINGS ..................7 EFERENCE EGULATIONS 1.3.1 EU Directives ......................7 1.3.2 Technical standards ....................7 1.3.3 Quality management system standards ............... 7 .......................
  • Page 4 INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 .................. 46 LECTRICAL SAFETY CHECK ................47 LEANING AND DISINFECTION 5.3.1 Recommended products for cleaning and disinfection ........48 5.3.2 Classification of the criticality of the device ............49 5.3.3 Device cleaning ....................49 5.3.4 Cleaning the applied parts.................. 50 5.3.5...

  • Page 5: Introduction

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 INTRODUCTION The device is the result of extensive research, conducted with experts to ensure the product's technical innovation, quality and design. The device can be used easily thanks to the guided manual acquisition and the electronic control of all its functions.

  • Page 6: Device Symbols

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 Medical device Waste disposal in compliance with Directives 2012/19/EU (WEEE) and 2011/65/EU (RoHS II) 1.1.1 DEVICE SYMBOLS Symbol Meaning Type B applied part Class II device GENERAL WARNINGS THESE INSTRUCTIONS FOR USE REFER TO THE COBRA+ DEVICE (HEREINAFTER “DEVICE”).

  • Page 7: Reference Regulations

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 Check potential damage device caused transport/storage prior to its use. It is forbidden to reproduce, in full or in part, texts or images contained in these instructions for use without the written authorization of the Manufacturer.

  • Page 8: Warranty

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 WARRANTY The Manufacturer is responsible for the compliance of the device with EU Directive 93/42/EEC as amended by 2007/47/EC for: performance safety and reliability CE marking The Manufacturer rejects all responsibility for: installation and start-up that is not carried out in compliance with...

  • Page 9: Manufacturer Identification

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 The warranty does not cover: repairs of malfunctions caused by natural disasters, mechanical shocks (falls, collisions, etc.), electrical system defects, negligence, misuse, maintenance or repairs carried out with non-original materials any other misuse or use not intended by the Manufacturer...

  • Page 10: Safety

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 SAFETY SAFETY WARNINGS DANGER Danger of electric shock. Do not let water fall on the device. Do not immerse the device in water or other liquids. DANGER Danger of electric shock. If the power supply cables are damaged, they must be replaced by an authorised Service Centre to prevent any risk.
  • Page 11 INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 CAUTION Danger of falling device. Do not leave loose cables, as they might be of obstacle or danger for the patient or operator. CAUTION Danger of tripping and falling. Do not leave the power supply or connection cables loose in places where people may walk.

  • Page 12: Device Identification

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 DEVICE IDENTIFICATION 2.2.1 REGISTRATION DATA IN THE LIST OF MEDICAL DEVICES The device registration data can be verified on this page of the website of the Ministry of Health: Ministero della Salute - Ricerca dispositivi 2.2.2 DEVICE DATA PLATE Fig.

  • Page 13: Power Supply Unit Data Plate

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 2.2.3 POWER SUPPLY UNIT DATA PLATE Fig. 3 - PSP2402 power supply unit data plate INTENDED USE Cobra+ is a medical device for observing the retinal fundus of the eye. The device is a non-mydriatic fundus camera designed for the detection, acquisition and processing of an image of the retina in ophthalmic practice.
  • Page 14 INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 The automatic measurement of the Cup to Disk ratio is very useful and fast in glaucoma screening. The measurement of the Cup to Disk ratio can be redefined manually by simply drawing its edge using the mouse.

  • Page 15: Medical Device Classification

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 Patient area: any volume in which a patient with applied parts may intentionally or unintentionally come into contact with other electromedical devices or electromedical systems, masses or foreign masses, or other people in contact with these elements.

  • Page 16: Electromedical Device Classification

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 ELECTROMEDICAL DEVICE CLASSIFICATION Classification in compliance with technical specification IEC 60601-1 Technical data Value Type of protection against direct and indirect Class I contacts Applied parts Type B IP20 (no protection against Degree of protection against humidity...

  • Page 17: Disposal At The End Of The Useful Life

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 DISPOSAL AT THE END OF THE USEFUL LIFE Instructions for the correct disposal of the device pursuant to European Directives 2012/19/EU and 2011/65/EU regarding the reduction of the use of dangerous substances in electrical and electronic equipment, as well as waste disposal.
  • Page 18 INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 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 as the new device, the Distributor or Manufacturer is legally required to collect the old device.

  • Page 19: Manufacturer Declarations

    Other products installed near or connected to the device. Accessories, cables and spare parts not specified in the instructions for use and not sold by CSO as spare parts. When using the device, certain precautions must be taken to respect EMC, including: Observe the instructions for use.
  • Page 20 INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 CAUTION The use of accessories, transducers and cables other than those specified or supplied by the manufacturer of this equipment could lead to increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
  • Page 21 INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 The device is designed to be used in a room with the following electromagnetic characteristics: Emission test Compliance Electromagnetic environment The device uses radio frequency energy only for its internal Radio frequency functioning. The device's emission.
  • Page 22 INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 IEC 60601-1-2 Compliance Electromagnetic Immunity test test level level environment The floors must be made of wood, concrete or ceramic Electrostatic ±6 kV in ±6 kV in contact. ±8 tile. If the floors are discharge. contact. ±8...
  • Page 23 INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 IEC 60601-1-2 Compliance Electromagnetic Immunity test test level level environment The magnetic fields at Magnetic field at mains frequency must mains frequency have the same levels 3 A/m 3 A/m (50/60Hz). as a typical IEC 61000-4-8 commercial or hospital environment.
  • Page 24 INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 (1) Portable and mobile RF communication equipment must be used no closer to any part of the device, including cables, than the recommended separation distance (d) calculated from the equation applicable to the frequency of the transmitter.

  • Page 25: Device Description

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 DEVICE DESCRIPTION SUPPLY DESCRIPTION Fig. 5 - Supply description Optional: accessory not provided with the basic supply. This document is the property of C.S.O. SRL. Any reproduction, even partial, is prohibited. 25/60...
  • Page 26 INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 Pos Name Description Adjustable height. Adjustable distance Chin rest between chin and forehead. Fixation point included. Protection against accidental crushing of Wheel cover fingers. Power supply A cable is provided with the power supply unit unit.

  • Page 27: Cobra+ Device

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 3.1.1 COBRA+ DEVICE Fig 6 - Cobra+ Device Pos Description Cobra+ Device Joystick Device locking knob Cogwheels Sliding rod USB connection cable between device and PC Connector Device power supply cable Shooting channel This document is the property of C.S.O. SRL.

  • Page 28: Power Supply Unit

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 3.1.2 POWER SUPPLY UNIT Fig. 7 - Power supply unit Pos Description Data plate Power supply unit Power supply status control light ON/OFF switch Device out connector Power grid connector Power supply cable from electric network Device power supply cable This document is the property of C.S.O.

  • Page 29: Chin Rest

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 3.1.3 CHIN REST Fig. 8 - Chin rest Pos Description Fixation point power supply cable Chin rest support Handle Chin cup adjustment knob Chin cup Forehead rest Chin rest structure Fixation point This document is the property of C.S.O. SRL.

  • Page 30: Ophthalmic Table

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 3.1.4 OPHTHALMIC TABLE Different table models are available based on the customer's choice. The table is composed of a table top on which the cogged wheels for the device compartment are installed. The table has one or two motorised telescopic columns that permit the height adjustment of the table top.
  • Page 31 INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 Fig. 10 - Personal Computer The PC must comply with Directive IEC 62368-1 Information technology equipment - Safety - Part 1: General requirements. If the PC is installed in the patient area, it is also necessary to install an isolation transformer compliant with Directive IEC 60601-1 - "Medical electrical equipment - Part 1: General requirements for...

  • Page 32: Technical Data

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 TECHNICAL DATA Technical data Value Data transfer USB3 External power supply unit 24 VCC Power supply In: 100-240Vac - 50/60Hz - 0.9-05A Out: 24 VDC 2A Network cable with C14 socket Dimensions (Height x Length x Depth)

  • Page 33: Device Use

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 DEVICE USE HOW TO INSTALL THE DEVICE CAUTION Danger of falling device. The table must be installed on a horizontal and stable surface. Place the ophthalmic table in the room. The table must be lifted by two people.
  • Page 34 INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 Check the position of the sticker with respect to the central axis (A). Remove the protective film. Place the sticker pad between the two cogged wheels and the sliding plate. While placing the sticker pad (sticker for right/left identification) on the table top, observe the specified distances.
  • Page 35 INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 Remove the joystick protection (B) under the device base. Fig. 15 – Protection removal Place the device on the table top and correctly align the cogwheels on the cogged guides. Fasten the two wheel covers to the cogged guides on the table top.
  • Page 36 INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 Install the chin rest. Beneath the table top, there are two screws to fasten the chin rest support to the table top. The chin rest must be installed so that the eye-level indicator (1) is placed at a height of 380 mm from the table top.
  • Page 37 INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 If the eye-level indicator does not reach the required height, adjust the chin rest. Loosen the 4 locking grub screws placed on the chin rest support. Slide the chin rest rods until the required height of 380 mm is reached.

  • Page 38: How To Connect The Device

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 HOW TO CONNECT THE DEVICE Fig. 22 - Device connection Pos Name USB connection cable between device and PC Power supply cable for the connection of the power supply unit to the device Power supply cable to connect the electric table to the power supply unit Power supply cable of the fixation point on the chin rest This document is the property of C.S.O.

  • Page 39: How To Arrange The Electric Cables

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 HOW TO ARRANGE THE ELECTRIC CABLES CAUTION Danger of falling device. Do not leave loose cables, as they might be of obstacle or danger for the patient or operator. CAUTION Danger of tripping and falling. Do not leave the power supply or connection cables loose in places where people may walk.

  • Page 40: How To Turn On The Device

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 HOW TO TURN ON THE DEVICE Before using the device, read the instructions in the Phoenix application software handbook. Turn on the PC. Switch the power switch of the power supply unit to turn it Start the Phoenix application software.

  • Page 41: How To Adjust The Chin Cup

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 HOW TO ADJUST THE CHIN CUP Ask the patient to sit down. Show the patient how to position their face against the chin cup and forehead rest. Check that the eye is correctly positioned in relation to the shooting channel.

  • Page 42: How To Acquire An Image

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 Raise or lower the chin cup by rotating the knob. Fig. 24 - Knob rotation Fig. 25 - Chin cup placement HOW TO ACQUIRE AN IMAGE Rotate the joystick and align the device with the patient's eye.
  • Page 43 INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 Focus the image using the wheel on the top of the joystick. Refer to the graphic indicator to focus the image. Press the joystick button to acquire the image. The image will be saved in the gallery.

  • Page 44: How To Replace Chin Cup Papers

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 HOW TO REPLACE CHIN CUP PAPERS At the end of each examination, always remove the chin cup paper, so that there is always a new sheet, to ensure hygiene for the next patient. This device is provided with a package of chin cup papers. After using the last chin cup paper, replace the pack.

  • Page 45: How To Turn Off The Device

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 HOW TO TURN OFF THE DEVICE CAUTION Do not turn off the computer and do not disconnect the connection cable between the computer and the device when the program is in use. Lock the device. Turn the locking knob.

  • Page 46: Ordinary Maintenance

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 ORDINARY MAINTENANCE SAFETY WARNINGS DANGER Danger of electric shock. Unplug the power supply cable from the power socket before disinfecting or cleaning the device and before any maintenance operation. CAUTION The device does not contain any parts requiring user intervention.

  • Page 47: Cleaning And Disinfection

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 CLEANING AND DISINFECTION CAUTION Carefully follow the instructions for cleaning and disinfection described in this manual, in order to avoid any damage to the device and accessories. CAUTION A correct cleaning and disinfection procedure, together with appropriate operating procedures, is essential to preventing the spread of infections or cross contamination.

  • Page 48: Recommended Products For Cleaning And Disinfection

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 5.3.1 RECOMMENDED PRODUCTS FOR CLEANING AND DISINFECTION CAUTION Danger of material damage. Do not use solvents, acidic or basic solutions (pH <4,5 or >8,0), abrasive or caustic substances, chlorine- based and chlorine-derived products. The Manufacturer is not liable for any damage caused by using disinfectant products not indicated in this manual.

  • Page 49: Classification Of The Criticality Of The Device

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 5.3.2 CLASSIFICATION OF THE CRITICALITY OF THE DEVICE CAUTION The device supplied is not sterile and must not be sterilised prior to use. This device is classified as "non-critical" since it is only used on intact skin and therefore has a low infectious risk.

  • Page 50: Cleaning The Applied Parts

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 5.3.4 CLEANING THE APPLIED PARTS CAUTION Danger of material damage. Only use detergent and disinfectant products specifically approved for medical devices or medical- surgical devices. The applied parts that come into direct contact with the patient during the examination must be thoroughly cleaned after each use with a disinfectant approved for the purpose.

  • Page 51: Device Excursion Check

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 DEVICE EXCURSION CHECK Check that the base sliding rod is well cleaned. Move the device base all the way to the right and all the way to the left, back and forth. Check that the device performs all movements completely.

  • Page 52: Troubleshooting

    INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 TROUBLESHOOTING Issue Cause Solution Note If the device is Connect the power powered through the supply cable of the table, check the The device Power cable not device to the power connection of the does not connected to the power supply unit.
  • Page 53 INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 Issue Cause Solution Note Unplug and then re- The connection cable plug the connection between the device and cable between the PC does not work device and the PC. The Phoenix properly. Replace the The installation of the...
  • Page 54 INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 Issue Cause Solution Note Check that the keyboard connection cable is Connection cable with properly inserted the PC disconnected. into the USB port. The power switch of the Turn on the Check whether there The PC...
  • Page 55 INSTRUCTIONS FOR USE COBRA+IFUENGCSO0104032024 Issue Cause Solution Note Make sure the Presence of dust or Clean the optical Failed image patient does not grease on the optical parts of the device focusing touch the optical parts of the device. with a soft cloth.
  • Page 60 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 COBRA+IFUENGCSO0104032024...

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