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INSTRUCTIONS FOR USE

 

 

COBRA HD | IFUCOBRAHDEN00

 

 

 

 This document is the property of  
CSO Costruzione Strumenti Oftalmici srl. 
Any reproduction, even partial, it is prohibited.  

 

10/48

 

 

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. 

2.2

 

DEVICE IDENTIFICATION 

2.2.1

 

REGISTRATION DATA IN THE MEDICAL DEVICES LIST 

CND (national medical devices classification)

 

Repertoire number (progressive system number attributed to the device)

 

Market release date

 

The device registration data can be verified on the Ministero della 

Salute website on this page: 

Ministero della Salute - Ricerca dispositivi  

2.2.2

 

DEVICE DATA PLATE 

 

Fig 1 - Plates position 

 

Pos

 

Description

 

A

 

Device data plate 

 

Summary of Contents for COBRA HD

Page 1: ...RA HD COSTRUZIONE STRUMENTI OFTALMICI 1 174 EN COSTRUZIONE STRUMENTI OFTALMICI phone 39 055 722191 fax 39 055 721557 cso csoitalia it www csoitalia it 0051 INSTRUCTIONS FOR USE Non mydriatic fundus camera ...

Page 2: ......

Page 3: ...pply data plate 11 2 3 INTENDED USE 12 2 4 MEDICAL DEVICES CLASSIFICATION 14 2 5 MEDICAL ELECTRICAL DEVICES CLASSIFICATION 15 2 6 ENVIRONMENTAL CONDITIONS 15 2 7 DISPOSAL AT THE END THE USEFUL LIFE 16 2 8 MANUFACTURER DECLARATIONS 18 2 8 1 Electromagnetic emissions 18 3 DEVICE DESCRIPTION 22 3 1 PROVISION DESCRIPTION 22 3 1 1 Device Cobra HD 24 3 1 2 Power supply 26 3 1 3 Chin rest 27 3 1 4 Electr...

Page 4: ...HD IFUCOBRAHDEN00 This document is the property of CSO Costruzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 2 48 5 2 DEVICE CLEANING 42 5 3 SPARE PARTS AND ACCESSORIES LIST 43 5 4 TROUBLESHOOTING 44 ...

Page 5: ... 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 1 1 SYMBOLS Within the instructions for use on the package or on the device there can be the following symbols Symbol Meaning Caution Warning electricity Read the instructions for use General mandatory action sign Note Useful information for the user General p...

Page 6: ...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 If you should decide to sell this appliance to other people remember to also include these instructions complete an...

Page 7: ...oncerning 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 1 General requirements for basic safety and essential performance EC 60601 1 2 2014 Edition 4 Collateral Standard Electromagnetic disturbances Requirements and tests UNI EN ISO 15004 1 2009 Ophthalmic Instruments Funda...

Page 8: ...lectrical 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 2...

Page 9: ...or maintenance carried out by personnel non authorized by the Manufacturer To ask maintenance interventions or to have technical information about the device address to an Authorized Service Center or directly to the device Manufacturer The client will not be refunded for damages originating from the device halt 1 5 MANUFACTURER IDENTIFICATION CSO S r l Costruzione Strumenti Oftalmici Via degli St...

Page 10: ...er to prevent any risk DANGER Electric shock danger Unplug the power cable from the mains socket before disinfecting the device and before any maintenance operation CAUTION Do not use the device if visibly damaged Periodically inspect the device and the connection cables to verify if there are damage signs CAUTION Always keep the device out of the reach of children CAUTION Danger of device fall Do...

Page 11: ...at turn it off immediately Do not keep using a damaged product or a damaged part Danger of injuries CAUTION The electrical net must have a Residual Current Circuit Breaker IΔn 30mA Thermal Magnetic Circuit Breaker Vn 230V to protect the device Place the device in such a way that the power socket is easily accessible it is forbidden to carry out any technical operation on the device that is not rec...

Page 12: ... appliances No preventive or corrective actions are required 2 2 DEVICE IDENTIFICATION 2 2 1 REGISTRATION DATA IN THE MEDICAL DEVICES LIST CND national medical devices classification Repertoire number progressive system number attributed to the device Market release date The device registration data can be verified on the Ministero della Salute website on this page Ministero della Salute Ricerca d...

Page 13: ... document is the property of CSO Costruzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 11 48 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 ...

Page 14: ...e AVR application software allows the measurement of the relationship between the branch arteriolar venous diameter A low relationship between the dimension of the vessels could be predictive of ictus and other cardiovascular events in adult patients Meibography The device allows to analyze the Meibomian glands in a non invasive method The miebography is performed through the infrared illumination...

Page 15: ...enix System minimum requirements PC 4 GB RAM Video Card 1 GB RAM not shared resolution 1024 x 768 pixels Operating system Windows XP Windows 7 and Windows 10 32 64 bit Read the instructions for use of the application software The PC must be compliant to the norm IEC 60950 1 Information technology equipment Safety Part 1 General requirements If the PC is installed in the patient area it is necessar...

Page 16: ... install an isolation electrical supply compliant with the directive IEC 60601 1 2005 A1 2102 Medical electrical equipment Part 1 General requirements for basic safety and essential performance Patient area any volume in which intentional or unintentional contact can occur between patient and parts of the system or between patient and other persons touching parts of the system Fig 5 Patient area 2...

Page 17: ...sinfected Protection degree in presence of anesthetics or inflammable detergents No protection Electrical connection degree between device and patient Appliances with part applied on the patient Use conditions Continuous functioning 2 6 ENVIRONMENTAL CONDITIONS Phase Technical data Min Max Transport Temperature 40 C 70 C Atmospheric pressure 500 hPa 1060 hPa Relative humidity 10 95 Storage Tempera...

Page 18: ... resources On the label of the device there is the symbol of the of the crossed out wheeled bin The graphic symbol of the crossed out wheeled bin indicates the obligation to collect and dispose separately the electrical and electronic equipment at the end of their useful life The user has to consider the effects potentially dangerous for the environment and the human health originating from an imp...

Page 19: ...spose a used device put on the market after the 13th August 2005 the Distributor or the Manufacturer have to collect it the Manufacturer takes care by joining a consortium for the technological devices waste of the treatment and the recycling of the used device by paying its costs The Manufacturer is available to give the user all the information about the dangerous substances contained in the dev...

Page 20: ...ause interferences with the near appliances Radio frequency emission CISPR 11 Class B The device can be used in all the environments included the domestic environment The device can be connected directly to a low tension power supply net as there is in the housing units Harmonic emissions IEC 61000 3 2 Class A The device can be used in all the environments included the domestic environment The dev...

Page 21: ... supply lines Non applicable Mains power quality shall be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality shall be that of a typical commercial or hospital environment Voltage dips Short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 Un for...

Page 22: ... and mobile RF communication equipment should be used no closer to any part of the device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter d 1 167 sqrt P d 1 167 sqrt P 80 MHz to 800 MHz d 2 333 sqrt P 800 MHz to 2 5 GHz P is the maximum output power rating of the transmitter in watts W according to the transmitte...

Page 23: ...reproduction even partial it is prohibited 21 48 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 ...

Page 24: ...OBRA HD IFUCOBRAHDEN00 This document is the property of CSO Costruzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 22 48 3 DEVICE DESCRIPTION 3 1 PROVISION DESCRIPTION Fig 6 Provision description ...

Page 25: ... images USB cable for connection between device and computer E Application software Application software for image capture and device management F Protective cover optional Place on the device when it is not in use to protect it from dust G Set of hex keys with screws optional H Package of paper for chin cup I Electric table optional Adjustable electric support surface with one or two columns Draw...

Page 26: ...CTIONS FOR USE COBRA HD IFUCOBRAHDEN00 This document is the property of CSO Costruzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 24 48 3 1 1 DEVICE COBRA HD Fig 7 Device Cobra HD ...

Page 27: ...i srl Any reproduction even partial it is prohibited 25 48 Pos Description A Device Cobra HD B Focus knob C LED illuminator D USB connector socket cover E Joystick F Device blocking knob G Cogged wheels H Shooting channel I Device power supply cable J Power supply connector K USB cable between device and computer ...

Page 28: ...nti Oftalmici srl Any reproduction even partial it is prohibited 26 48 3 1 2 POWER SUPPLY Fig 8 Power supply Pos Description A Data plate B Power supply C Power ON control light D ON OFF switch E Power supply out connector F Power supply mains connector G Power supply cable H Device power supply cable ...

Page 29: ...CSO Costruzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 27 48 3 1 3 CHIN REST Fig 9 Chin rest Pos Description A Connection cable for fixation point B Chin rest support C Handle D Knob E Chin cup F Forehead rest G Chin rest structure H Fixation point ...

Page 30: ...NAL 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 Fig 10 One column table Fig 11 Two columns table Read the instructions for use of the electric table ...

Page 31: ...0 x 410 mm Weight 6 kg Chin rest stroke 70 mm 1 Minimum height of the chin cup from the working plan 23 cm Base movement x y z 105 x 110 x 30 mm Working distance 20 mm Light sources Technical data Value Auxiliary Led 850nm Flash Led 450 650nm Retinography Technical data Value Spherical ametropia correction from 20D to 10D through handle placed on the joystick Image resolution 2448 x 2051 5 MPixel ...

Page 32: ...installed on a horizontal and stable surface 1 Place the electric table in the room The electric table must be lifted by two people 2 If present block the table wheels Lower the lever of the brake 3 Place the power supply under the support plane Screw the screws in the four holes Fig 12 Table placement Fig 13 Power supply placement 4 Place the device on the support surface on the cogged guides 5 B...

Page 33: ...oduction even partial it is prohibited 31 48 Fig 14 How to place the device Fig 15 Protection carters placement 6 Install the chin rest Under the support plane there are two screws to block the chin rest support to the support plane 7 Carry out the electrical connection between the several components Fig 16 Chin rest placement ...

Page 34: ... FOR USE COBRA HD IFUCOBRAHDEN00 This document is the property of CSO Costruzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 32 48 4 2 HOW TO CONNECT THE DEVICE Fig 17 Device connection ...

Page 35: ...or the connection between the power supply and the device D Power cable for the connection of the electric table with the power supply E Power cable for the connection of the electric table with the power supply To connect the cable USB 3 0 and the device you need to open the protection carter on the front part of the device 1 Unscrew the screw and remove the protection carter 2 Connect the USB co...

Page 36: ...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 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 It is forbidden to use any extension cable not ...

Page 37: ...er the support plane 4 4 HOW TO TURN ON THE DEVICE 1 Turn on the PC 2 Push the activation switch of the power supply on ON 3 Launch the application software Phoenix 4 Wait until the main screen of the application software is shown 5 Click on NEW PATIENT and enter his personal data If the patient is already present in the database you can automatically search the surname in the surname command line...

Page 38: ... Any reproduction even partial it is prohibited 36 48 4 5 ADJUST THE CHIN REST 1 Tell the patient to take a seat 2 Ask the patient to put the chin on the chin cup and the forehead against the forehead rest 3 Verify the correct eyes position respectively to the shooting channel Fig 22 Patient position on the chin rest ...

Page 39: ...TRUCTIONS FOR USE This document is the property of CSO Costruzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 37 48 4 Lift or lower the chin cup as needed Fig 23 Knob rotation Fig 24 Chin cup placement ...

Page 40: ...lign with the retinal reflection until the image of the retina appears 3 Slightly move the joystick in order to obtain the best condition of the image for what it concerns the illumination homogeneity and the field wideness Fig 25 How to place the device Fig 26 Distance from the patient 4 Focus the image by means of the roller on the upper part of the device Refer to the graphic indicator to focus...

Page 41: ...is document is the property of CSO Costruzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 39 48 Fig 27 Image focus Fig 28 Image capture Refer to the application software instructions for the image managing in the database ...

Page 42: ...cup in order to always have a new and hygienic one for the next patient This device is provided with a package of paper for chin cup When you use the last paper change the package 1 Extract the two plastic rivets 2 Place the new package of paper for chin cup 3 Insert the plastic rivets in the holes of the package and in the holes of the chin cup Fig 29 How to change the papers for chin cup To orde...

Page 43: ...N 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 1 Immobilize the device Turn the locking knob 2 Exit the images management systems program Turn off the computer 3 Push the activation switch of the power supply on OFF 4 Place the protective cover on the device to prevent dust to fall on the device Fig 30 Device...

Page 44: ...requires the user s intervention Do not dismantle any part of the device it is forbidden to carry out any maintenance operation on the device that is not recalled in instructions for use In case of operational faults or malfunctions or for every operation not mentioned in the instructions for use there is the obligation to address an authorized technical assistance center of the device Manufacture...

Page 45: ...0 Isolation transformer 230V 230V Power supply cable 800 VA maximum charge 4014020 Package of paper for chin cup 50 pieces 4013095 Protective cover 103301800 Table top 45x90 mm 10070144 Electric support plane with one column 230 V 50 Hz 33071095 Power supply cable for electric support 95 cm 103103900 PSP2402 input 100 240 V AC 50 60 Hz max 0 9 A output 24 VDC 2 A 100104700 Chin rest for the table ...

Page 46: ...evice is powered trough the auxiliary power supply of the table check the connection of the table to the power line Check the functioning of the table fuses The PC does not start Power cable not connected with the power supply Connect the power cable to the power supply Push the button of the power supply on ON Replace the PC Make sure the power outlet of the room works properly PC Operating syste...

Page 47: ...tem Reinstall the application software Phoenix Contact the Technical Assistance Center The installation of the application software Phoenix needs the administrator privileges The application software Phoenix does not work properly The connection cable between device and PC does not work properly The anti virus software interferes with the drivers of the application software Phoenix The application...

Page 48: ...ble properly fit in USB port Switch the mouse button in position ON Replace mouse batteries only for wireless mouse From the control panel of the PC check that there are no devices conflicts The keyboard of the PC does not work Connection cable with the PC disconnected Keyboard switch in position OFF The keyboard batteries are down only for wireless keyboard Check that the keyboard connection cabl...

Page 49: ...tion screen of the database is specified the correct path to the phoenix mdb file Restore the connection to the database file Check the functioning of the net connection Replace the USB cable Regularly verify the connections with the data net Failed image capture The patient moved or closed the eyes during the capture Ask the patient to keep the eyes open look the fixation light and not to move th...

Page 50: ...ctor Install the black sticker below the base of the device Some colors and material of the table top may not reflect the infrared light Move a white paper below the base of the device to check the functioning of the positioning detector Device movement difficulties ahead back left right The joystick plastic protection has not been removed from the base during the installation Device blocking knob...

Page 51: ......

Page 52: ...COSTRUZIONE STRUMENTI OFTALMICI phone 39 055 722191 fax 39 055 721557 cso csoitalia it www csoitalia it 4 174 COBRA HD IFUCOBRAHDEN00 del 06 2018 ...

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