MS-39
COSTRUZIONE STRUMENTI OFTALMICI
INSTRUCTIONS FOR USE
1/174
EN
phone: +39 055 722191 | fax: +39 055 721557
[email protected] |
www.csoitalia.it
0051
AS-OCT
IFU302EN00 - 03/2019
Страница 1: ...MS 39 COSTRUZIONE STRUMENTI OFTALMICI INSTRUCTIONS FOR USE 1 174 EN COSTRUZIONE STRUMENTI OFTALMICI phone 39 055 722191 fax 39 055 721557 cso csoitalia it www csoitalia it 0051 AS OCT IFU302EN00 03 2019 ...
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Страница 3: ...upply data plate 11 2 3 INTENDED USE 12 2 4 MEDICAL DEVICES CLASSIFICATION 17 2 5 MEDICAL ELECTRICAL DEVICES CLASSIFICATION 18 2 6 ENVIRONMENTAL CONDITIONS 18 2 7 DISPOSAL AT THE END THE USEFUL LIFE 19 2 8 MANUFACTURER DECLARATIONS 21 2 8 1 Electromagnetic emissions 21 3 DEVICE DESCRIPTION 24 3 1 PROVISION DESCRIPTION 24 3 1 1 Device MS 39 AS OCT 26 3 1 2 Power supply unit 27 3 1 3 Chin rest 28 3 ...
Страница 4: ...00 03 2019 This document is the property of CSO Costruzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 2 52 5 1 SAFETY WARNINGS 46 5 2 DEVICE CLEANING 46 5 3 SPARE PARTS AND ACCESSORIES LIST 47 5 4 TROUBLESHOOTING 48 ...
Страница 5: ...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 1 1 SYMBOLS Within the instructions for use on the package or on the device there can be the following symbols Symbol Meaning Caution Danger of electric shock Read the instructions for use General obligation Note Useful information for the user General ...
Страница 6: ...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 and readable Keep the original box and packaging...
Страница 7: ...c 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 Fundamental requirements and test methods Part 1 General requirements applicable to a...
Страница 8: ...rer 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 ...
Страница 9: ...use 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 Centre 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 degl...
Страница 10: ...hock 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 falling down Do not leave free cables which can...
Страница 11: ... 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 recalled or described in these instructions for use It is forbidden to place the device in humid dusty places or environments sub...
Страница 12: ...tion even partial it is prohibited 10 52 2 2 DEVICE IDENTIFICATION 2 2 1 REGISTRATION DATA IN THE MEDICAL DEVICES LIST The device registration data can be verified on the Ministero della Salute website at this page Ministero della Salute Ricerca dispositivi 2 2 2 DEVICE DATA PLATE Fig 1 Plates position Pos Description A Device data plate ...
Страница 13: ...STRUCTIONS FOR USE This document is the property of CSO Costruzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 11 52 Fig 2 Device data plate 2 2 3 POWER SUPPLY DATA PLATE Fig 3 Power supply PSP2404 data plate ...
Страница 14: ... mesopic photopic conditions and in dynamic mode and their integration with corneal map On the basis of the pachymetry map and corneal elevation data the device allows the intrastromal rings system planning for the correction of refractive defects and some forms of keratoconus The device allows the glaucoma screening and gives the measurement of irido corneal angles and pachymetry These values and...
Страница 15: ...ondition 50 lux Perform the dynamic pupillometry measurement starting form 400 lux and turning off the luminous source so that the pupil dilates to its maximal extension Evaluate the pupillary decentralization with respect to the corneal vertex for each of the conditions described above and the pupillary centre deviation during the dilatation Analysis of the tear film The Placido s disk allows the...
Страница 16: ... measure the crystalline lens thickness its distance from the cornea and its equator Glaucoma screening The device allows the glaucoma screening and gives the measurement of irido corneal angles AOD TISA and corneal pachymetry These values and the most common IOP correction formulas are useful to diagnose some diseases which can be due to the conformation of the anterior chamber Keratoconus screen...
Страница 17: ...ap maps summaries analysis of the anterior segment aberrations analysis of the differential maps advanced editing system of the rings which allows to modify the position of the edges in order to provide a proper reconstruction even on distorted surfaces availability of the following maps sagittal curvature map tangential curvature map elevation refractive power Gaussian curvature map corneal thick...
Страница 18: ...s of the cornea such as Sim K to simulate the measurement of an ophthalmoscope with fixed targets for the anterior surface principal corneal meridians in the zones of 3 mm 5 mm and 7 mm flatter and steeper hemi meridians in the zones of 3 mm 5 mm and 7 mm peripheral degrees pupil decentralization pupil diameter and corneal diameter size keratorefractive indices calculated in the pupil area for an ...
Страница 19: ...rists within the limits of the law and the regulations for the exercise of the profession 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 4 Patient area 2 4 MEDICAL DEVICES CLASSIFICATION Technical data Value Classification in compliance with the attached IX...
Страница 20: ... disinfected Protection degree in presence of anaesthetics 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 Tem...
Страница 21: ...and 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 ...
Страница 22: ...o dispose 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...
Страница 23: ...ot cause 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...
Страница 24: ... Test level Portable and mobile RF communication equipment should be used no closer to any part of the device including cables Minimum distance 30 cm Electrical fast transient burst IEC 61000 4 4 2kV for power supply lines 1kV for input output lines 3 m IEC 60601 1 2 Test level Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 0 5 1kV differenti...
Страница 25: ...1000 4 11 0 Un for 0 5 cycle 0 Un for 1 cycle 70 Un for 25 cycles 0 Un for 5 s IEC 60601 1 2 Test level Mains power quality should be that of a typical commercial or hospital environment If the user of the device requires continued operation during power mains interruptions it is recommended that the device is powered from an uninterrupted power supply or battery Power frequency 50 60Hz magnetic f...
Страница 26: ...Costruzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 24 52 3 DEVICE DESCRIPTION 3 1 PROVISION DESCRIPTION Fig 5 Supply description Optional accessory not provided with the basic supply Accessories marked by are essential for the proper functioning of the device ...
Страница 27: ... micro video cameras for capturing the images USB cable for connection between device and computer F Personal Computer and application Software Application software for image capture and device management G Protective cover Place on the device when it is not in use to protect it from dust H Hex wrench with screws I Package of paper for chin cup Papers to be placed on the chin cup of the chin rest ...
Страница 28: ...ci srl Any reproduction even partial it is prohibited 26 52 3 1 1 DEVICE MS 39 AS OCT Fig 6 Device MS 39 AS OCT Pos Description A Device MS 39 AS OCT B Joystick C Device blocking knob D Cogged wheels E USB connection cable between device and computer F Power port G Device power cable H Shooting channel I Calibration rod ...
Страница 29: ...nti Oftalmici srl Any reproduction even partial it is prohibited 27 52 3 1 2 POWER SUPPLY UNIT Fig 7 Power supply Pos Description A Data plate B Power supply unit C Supply status control light D ON OFF switch E Power supply out connector F Power supply mains connector G Power supply cable H Device power cable ...
Страница 30: ...t is the property of CSO Costruzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 28 52 3 1 3 CHIN REST Fig 8 Chin rest Pos Description A Chin rest support B Handle C Chin cup adjustment knob D Chin cup E Forehead rest F Chin rest structure ...
Страница 31: ...PHTHALMIC TABLE 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 9 One column table Read the instructions for use of the ophthalmic table ...
Страница 32: ...t Read the instructions for use of the application software Fig 10 Personal Computer 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 necessary to install an insulating transformer compliant with the directive IEC 60601 1 2005 A1 2012 Medical electrical equipment Part 1 General requ...
Страница 33: ... with the directive IEC 60601 1 2005 A1 2102 Medical electrical equipment Part 1 General requirements for basic safety and essential performance 3 2 TECHNICAL DATA Technical data Value Data transfer USB 3 0 Mains power External power supply 24 VCC In 100 240Vac 50 60Hz 2A Out 24Vdc 100W Net cable with C14 socket Dimensions Height x Length x Depth 505 x 315 x 251 mm Weight 10 4 kg Chin rest stroke ...
Страница 34: ...d points 31232 anterior surface 25600 posterior surface Topographic covering 10 mm Dioptric range from 1D to 100D Accuracy Class A according to UNI EN ISO 19980 2012 Section Technical data Value Image field 16 mm x 8 mm Axial resolution 3 6 µm in tissue Transverse resolution 35 µm in air Image s resolution Keratoscopy 640x480 25 radial scans over transverse field of 16 mm 1024 A scan Section over ...
Страница 35: ...NSTALL THE DEVICE CAUTION Danger of device falling down The table must be installed on a horizontal and stable surface 1 Place the ophthalmic table in the room The 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 11 Table placement Fig 12 Power supply unit plac...
Страница 36: ...l it is prohibited 34 52 4 Verify the sticker position respectively to the central axis A 5 Remove the protection film Place the sticker pad between the two cogged wheels and the scrolling plate Respect the indicated distances while placing the sticker pad for right left identification on the table top Fig 13 Distances Fig 14 How to place the sticker pad ...
Страница 37: ...tion A placed under the device base Fig 15 Protection removal 7 Place the device on the support plane and align the cogged wheels on the cogged guides 8 Block the two protection carters to the cogged wheels on the support plane Fig 16 Placing the device Fig 17 Placing protection carters 9 Install the chin rest Under the support plane there are two screws to block the chin rest support to the suppo...
Страница 38: ...02EN00 03 2019 This document is the property of CSO Costruzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 36 52 10 Carry out the electrical connection between the several components Fig 18 Placing the chin rest ...
Страница 39: ...ited 37 52 4 2 HOW TO CONNECT THE DEVICE Fig 19 Device connection Pos Denomination A USB connection cable between device and PC B Power cable for the connection between the power supply and the device C Power cable for the connection of the electric table with the power supply To power the table basement read instructions for use of the table or of the ophthalmic unit ...
Страница 40: ...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 authorized by the manufacturer For the proper placement of electrical cables and connection to the elevation column read instructions for use of ophthalmic tables or of ophthalmic units The instruction manual can a...
Страница 41: ...lication software The instruction manual can also be downloaded from the website www csoitalia it_ or you can read the application software guide 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 6 A new examination will be created automatically 7 Select the device to use 8 The i...
Страница 42: ... Any reproduction even partial it is prohibited 40 52 4 5 HOW TO ADJUST THE CHIN REST 1 Inform 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 20 Patient position on the chin rest ...
Страница 43: ...INSTRUCTIONS FOR USE This document is the property of CSO Costruzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 41 52 4 Lift or lower the chin cup as needed Fig 21 Knob rotation Fig 22 Placing the chin cup ...
Страница 44: ...ith the patient s eye 2 Move towards the eye with the tool Keep centred the reflection of the corneal vertex in both the images 3 Perform some micro movements with the joystick to obtain the best image alignment Fig 23 Placing the device Fig 24 Distance from the patient 4 Push down the joystick to confirm and capture the image The image will be saved in the gallery 5 Double click on the captured i...
Страница 45: ... FOR USE This document is the property of CSO Costruzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 43 52 Fig 25 Image acquisition Refer to the application software instructions for the image managing in the database ...
Страница 46: ...chin 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 26 How to change the chin cup papers To ord...
Страница 47: ...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 1 Immobilize the device Turn the locking knob 2 Launch the application software Phoenix 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 27 Dev...
Страница 48: ...hat 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 centre of the device Manufac...
Страница 49: ...ver 10070524 Table top 45x90 mm 103301800 Electric support plane with one column 230 V 50 Hz 103106H00 Mobile multivoltage table 100 240V 50 60Hz with double column for support plane for OCT instrument and PC screen 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 300409135 Power supply cable 1 5 m 300409136 Power supp...
Страница 50: ... the device 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...
Страница 51: ...tall the application software Phoenix Contact the Technical Service Centre 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 antivirus software interferes with the drivers of the application software Phoenix The application software Pho...
Страница 52: ...n cable 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 ...
Страница 53: ... 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 the eyes Poor image quality from Placido s disk The tear film is not well distribut...
Страница 54: ...detector Install the black sticker below the base of the device Some colours 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...
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Страница 56: ...4 174 COSTRUZIONE STRUMENTI OFTALMICI phone 39 055 722191 fax 39 055 721557 cso csoitalia it www csoitalia it MS 39 AS OCT IFU302EN00 03 2019 ...
