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Summary of Contents for CSO COBRA HD
- Page 1 COSTRUZIONE STRUMENTI OFTALMICI COBRA HD Non-mydriatic fundus camera INSTRUCTIONS FOR USE COSTRUZIONE STRUMENTI OFTALMICI phone: +39 055 722191 | fax: +39 055 721557 cso@csoitalia.it | www.csoitalia.it 0051 1/174...
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Page 3: Table Of Contents
................18 ANUFACTURER DECLARATIONS 2.8.1 Electromagnetic emissions ................. 18 DEVICE DESCRIPTION ................22 ..................22 ROVISION DESCRIPTION 3.1.1 Device Cobra HD ....................24 3.1.2 Power supply ...................... 26 3.1.3 Chin rest ......................27 3.1.4 Electric table (optional) ..................28 ....................29 ECHNICAL DATA DEVICE USE ..................... - Page 4 INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 ..................... 42 EVICE CLEANING ..............43 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. 2/48...
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Page 5: Introduction
INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 INTRODUCTION The device is the result of a long research period, conducted by experts to give the product technical innovation, quality and design. The device can be easily used thanks to the guided manual capture and the electronic control of all the functions of the device. -
Page 6: Device Symbols
Class II equipment GENERAL WARNINGS THESE INSTRUCTIONS FOR USE REFER TO THE DEVICE COBRA HD("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. Read the instructions given in the instructions manual and reported on the device? Keep this manual close by for future consultation. -
Page 7: Normative References
INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 Verify the presence of damage signs on the device caused by the transport/storage, before using the device. 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 COBRA HD | IFUCOBRAHDEN00 WARRANTY The Manufacturer is responsible for the device conformity to the Community directive 93/42/EEC as amended by the 2007/47/EC for: features safety and reliability CE marking The Manufacturer refuses any responsibility for: installation and activation not activated in conformity to the... -
Page 9: Manufacturer Identification
INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 the parts subject to usage and/or deterioration originating from the normal use and those that might be broken because of an improper use or maintenance carried out by personnel non- authorized by the Manufacturer. -
Page 10: Safety
INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 SAFETY SAFETY WARNINGS DANGER Electric shock danger. Do not let water fall on the device. Do not immerse the device in water or other liquids. DANGER Electric shock danger. If the power cables are damaged they must be replaced in an Authorized Service Center to prevent any risk. - Page 11 INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 CAUTION Electric shock risk. Do not touch the power supply cables with wet hands. CAUTION Electric shock risk. Do not leave the power supply cables in contact with sharp corners or objects. Collect and attach always the power supply cables.
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Page 12: Device Identification
INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 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. DEVICE IDENTIFICATION 2.2.1 REGISTRATION DATA IN THE MEDICAL DEVICES LIST... -
Page 13: Power Supply Data Plate
INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 Fig 2 - Device data plate 2.2.3 POWER SUPPLY DATA PLATE Fig 3 - Power supply PSP2402 data plate Fig 4 - Power supply PSP2404 data plate This document is the property of CSO Costruzione Strumenti Oftalmici srl. -
Page 14: Intended Use
INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 INTENDED USE COBRA HD non-mydriatic Fundus camera is an electro-medical device for the observation of the retinal fundus of the eye. The device is a non-mydriatic fundus camera which has been designed for the screening, the capture and the elaboration of an image of the retina in the ophthalmic procedure. - Page 15 INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 retinal image overlap with multifocal ERG Edge enhancement Contrast and luminance control and control of each RGB component and range correction Image in grayscale, ref free, and channel separation Image with inverted colors The device must be used only by practitioners, within the limits of the law and the regulations for the exercise of the profession.
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Page 16: Medical Devices Classification
INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 The accessories must be compliant to the norm IEC 60950-1 Information technology equipment - Safety - Part 1: General requirements. If the accessories are installed in the patient area it is necessary to install an isolation electrical supply compliant with the directive IEC 60601-1:2005 + A1:2102 - "Medical electrical equipment - Part 1:... -
Page 17: Medical Electrical Devices Classification
INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 MEDICAL ELECTRICAL DEVICES CLASSIFICATION Classification in compliance with the technical specification EN 60601- 1:2005 + A1:2012 Technical data Value Type of protection against the direct Class II and indirect contacts Applied parts Type B... -
Page 18: Disposal At The End The Useful Life
INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 DISPOSAL AT THE END THE USEFUL LIFE Instruction for disposal of product correctly according to European Directive 2012/19/EU, and 2011/65/EU about the reduction of use of dangerous substances in the electrical and electronic equipments, and waste disposal. - Page 19 INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 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 20: Manufacturer Declarations
INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 MANUFACTURER DECLARATIONS 2.8.1 ELECTROMAGNETIC EMISSIONS 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 inner functioning. - Page 21 INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 IEC 60601-1-2 Conformity Electromagnetic Immunity test test level level environment Floors should be wood, concrete or ceramic tile. If Electrostatic ±6 kV contact. ±6 kV contact. the floors are covered discharge. IEC ±8 kV air ±8 kV air...
- Page 22 INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 IEC 60601-1-2 Conformity Electromagnetic Immunity test test level level environment Power frequency of the Power frequency magnetic fields should be (50/60Hz) 3 A/m 3 A/m that of a typical magnetic fields. commercial or hospital IEC 61000-4-8 environment.
- Page 23 INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 (Un) is the AC mains voltage prior to application of the test level. 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.
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Page 24: Device Description
INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 DEVICE DESCRIPTION PROVISION DESCRIPTION Fig 6 - Provision description This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 22/48... - Page 25 INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 Denomination Description Chin rest Adjustable height Adjustable distance between chin and forehead Protection carter Protection against accidental hand crushing. Power supply Device Cobra HD Composed by a camera unit equipped with micro video camera for capturing the images.
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Page 26: Device Cobra Hd
INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 3.1.1 DEVICE COBRA HD Fig 7 - Device Cobra HD This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 24/48... - Page 27 INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 Description Device Cobra HD Focus knob LED illuminator USB connector socket cover Joystick Device blocking knob Cogged wheels Shooting channel Device power supply cable Power supply connector USB cable between device and computer This document is the property of CSO Costruzione Strumenti Oftalmici srl.
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Page 28: Power Supply
INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 3.1.2 POWER SUPPLY Fig 8 - Power supply Description Data plate Power supply Power ON control light ON/OFF switch Power supply out connector Power supply mains connector Power supply cable Device power supply cable This document is the property of CSO Costruzione Strumenti Oftalmici srl. -
Page 29: Chin Rest
INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 3.1.3 CHIN REST Fig 9 - Chin rest Description Connection cable for fixation point Chin rest support Handle Knob Chin cup Forehead rest Chin rest structure Fixation point This document is the property of CSO Costruzione Strumenti Oftalmici srl. -
Page 30: Electric Table (Optional)
INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 3.1.4 ELECTRIC TABLE (OPTIONAL) Different table models are available accordingly to the client's choice. The electric table is composed by a support surface on which are installed the cogged guides for the device housing. The table has one or two telescopic columns, motorized, that allow to adjust the height of the support plane. -
Page 31: Technical Data
INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 TECHNICAL DATA Technical data Value Data transfer USB 3.0 External power supply 24 VCC. In: 100- Mains power 240Vac - 50/60Hz - 0.9-05A Out: 24Vdc - 40W Net cable with C14 socket Dimensions (Height x Length x Depth) -
Page 32: Device Use
INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 DEVICE USE HOW TO INSTALL THE DEVICE CAUTION Danger of device fall. The electric table must be installed on a horizontal and stable surface. Place the electric table in the room. The electric table must be lifted by two people. - Page 33 INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 Fig 14 - How to place the device Fig 15 - Protection carters placement Install the chin rest. Under the support plane, there are two screws to block the chin rest support to the support plane.
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Page 34: How To Connect The Device
INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 HOW TO CONNECT THE DEVICE Fig 17 - Device connection This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 32/48... - Page 35 INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 Denomination USB 3.0 cable between device and PC Connection cable for fixation point on the chin rest Power cable for the connection between the power supply and the device Power cable for the connection of the electric table with the power...
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Page 36: How To Place The Electric Cables
INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 HOW TO PLACE THE ELECTRIC CABLES CAUTION Danger of device fall. Do not leave free cables which can represent an obstacle or a danger for the patient or the operator. CAUTION Danger of stumbling and falling. Do not let the power cord or the connection cables free in a place where people could walk. -
Page 37: How To Turn On The Device
INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 The power socket is on the column of the electric table, below, and it has to be used for the connection with the mains power. One of the power sockets on the column of the electric table, on top, is dedicated to the device power supply. -
Page 38: Adjust The Chin Rest
INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 ADJUST THE CHIN REST Tell the patient to take a seat. 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. - Page 39 INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 Lift or lower the chin cup as needed. Fig 23 - Knob rotation Fig 24 - Chin cup placement This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited.
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Page 40: How To Capture The Image
INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 HOW TO CAPTURE THE IMAGE Turn the joystick and align the device with the patient's eye. Move towards the eye with the tool and align with the retinal reflection until the image of the retina appears. - Page 41 INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 Fig 27 - Image focus Fig 28 - Image capture Refer to the application software instructions for the image managing in the database. This document is the property of CSO Costruzione Strumenti Oftalmici srl.
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Page 42: How To Change The Paper For Chin Cup
INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 HOW TO CHANGE THE PAPER FOR CHIN CUP At the end of each exam remove the paper for chin cup in order to always have a new and hygienic one for the next patient. -
Page 43: How To Turn Off The Device
INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 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. Immobilize the device. Turn the locking knob. -
Page 44: Ordinary Maintenance
INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 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 45 INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 SPARE PARTS AND ACCESSORIES LIST Code Description 30010071D3F Power supply cable Isolation transformer 230V/230V. Power supply 10101300 cable 800 VA (maximum charge) 4014020 Package of paper for chin cup (50 pieces) 4013095 Protective cover...
- Page 46 INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 TROUBLESHOOTING Inconvenient Cause Solution Note If the device is powered trough Connect the the auxiliary power cable of power supply of Power cable not The device does the device to the the table, check...
- Page 47 INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 Inconvenient Cause Solution Note Hard Disk failure. The anti virus Replace the Hard Contact the software impedes Disk. Check the Technical the starting of the settings of the Assistance application anti virus Center. The The application software Phoenix.
- Page 48 INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 Inconvenient Cause Solution Note Check that the Connection cable mouse with the PC connection cable disconnected. From the control properly fit in USB Mouse switch in panel of the PC, The mouse of the port.
- Page 49 INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 Inconvenient Cause Solution Note Verify that in the configuration screen of the database is The database is specified the not connected correct path to with the The images can't application Regularly verify “phoenix.mdb”...
- Page 50 INSTRUCTIONS FOR USE COBRA HD | IFUCOBRAHDEN00 Inconvenient Cause Solution Note Some colors and material of the table top may not Missing Missing reflect the installation of acknowledgment Install the black infrared light. black sticker of eye position sticker below the...
- Page 52 4/174 COSTRUZIONE STRUMENTI OFTALMICI phone: +39 055 722191 | fax: +39 055 721557 cso@csoitalia.it | www.csoitalia.it COBRA HD| IFUCOBRAHDEN00 del 06/2018...
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