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CSO POLARIS, Instructions For Use Manual, Page: 4 / 48

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Page 1: ...TRUZIONE STRUMENTI OFTALMICI 1 174 IT COSTRUZIONE STRUMENTI OFTALMICI phone 39 055 722191 fax 39 055 721557 cso csoitalia it www csoitalia it POLARIS Advanced analysis of the tear film INSTRUCTIONS FOR USE ...

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Page 3: ...AL 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 Accessory device Polaris 24 3 1 2 Tools kit 25 3 2 TECHNICAL DATA 26 4 DEVICE USE 27 4 1 HOW TO INSTALL THE DEVICE 27 4 2 HOW TO CONNECT THE DEVICE 30 4 3 HOW TO PLACE THE ELECTRIC CABLES 32 4 4 HOW TO INSERT THE ...

Page 4: ...N00 This document is the property of CSO Costruzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 2 44 5 1 SAFETY WARNINGS 43 5 2 DEVICE CLEANING 43 5 3 SPARE PARTS AND ACCESSORIES LIST 44 5 4 TROUBLESHOOTING 44 ...

Page 5: ...oduct technical innovation quality and design The device is an accessory for the slit lamp it allows an accurate analysis of the patient s tear film 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 ...

Page 6: ...ARIS 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 ...

Page 7: ...ications and integrations concerning 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 O...

Page 8: ...trical 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 m...

Page 9: ... 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 Stag...

Page 10: ...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 down Do not leave free cables which can represe...

Page 11: ...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 the instructions for use It is forbidden to place the device in humid dusty places or environments subject to ...

Page 12: ... PLATE Fig 1 Plate position Pos Description A Device data plate Fig 2 Device data plate 2 3 INTENDED USE POLARIS is a device for the advanced analysis of the tear film Itallows to estimate the quality and quantity of the tear film Through non invasive break up time test NIBUT it is possible to analyze its stability and regularity Others test allows to evaluate the corneal surface and the lower tea...

Page 13: ...uminator The light source of white light prevents excessive tearing or evaporation of the tear film Through the Slit Lamp microscope the image projected by the device reflected on the patient s eye tear film is observed by the microscope The device can be perfectly integrated with the application software Phoenix Lipid film quality and quantity The device enables interferometric examination of the...

Page 14: ...e non invasive break up time is the measurement in seconds of the time between the last complete blinking and the appearance of the film discontinuity on the tear film The observed pre rupture phase indicates the tear film thinning time These measurements can be taken with or without contact lenses Corneal surface regularity The device can also be used to assess the regularity of the corneal surfa...

Page 15: ...ical supply compliant with the directive IEC 60601 1 2005 A1 2012 Medical electrical equipment Part 1 General requirements for basic safety and essential performance It is possible to connect other accessories to the PC printer modem scanner etc through the analogical or digital interfaces The accessories printer modem scanner etc must be installed outside the patient area The accessories must be ...

Page 16: ...ient 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 3 Patient area 2 4 MEDICAL DEVICES CLASSIFICATION Technical data Value Classification in compliance with the attached IX to the Directive 93 42 EEC and successive modifications Class I ...

Page 17: ...ection against liquid infiltration Sterilization or disinfection method This device can be disinfected 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 Temper...

Page 18: ... the end of its useful life the device must not be disposed of as urban waste The device can be delivered to the appropriate separate waste collection centers set up by municipal administrations or to retailers that offer this service Separately disposing an electrical device prevents possible negative consequences for the environment and health caused by its improper disposal and lets the materia...

Page 19: ...tion in charge for waste collection 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 if the user decides to dispose a used device put on the market after the 13th August 2005 th...

Page 20: ...e 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 device...

Page 21: ...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 0 5 cycles 40 Un for 5 cycles 70 Un for 25 cycles 5 Un for 5 s 5 Un for 0 5 cycles 40 ...

Page 22: ...ce 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 transmitter Manufacturer d is the recommended distance in metres m at which the portable radio fr...

Page 23: ...roduction even partial it is prohibited 21 44 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: ...E POLARIS IFU312EN00 This document is the property of CSO Costruzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 22 44 3 DEVICE DESCRIPTION 3 1 PROVISION DESCRIPTION Fig 4 Provision description ...

Page 25: ...d of a white LED illumination unit USB power stick and cable compatible with the device for the connection between computer or external power supply to use it without a PC B Tools kit The set includes three film grids fine grid negative grid Placido s disk C Isolation transformer optional D Power supply USB optional E Device case For the list of accessories and available models contact the Manufac...

Page 26: ...ione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 24 44 3 1 1 ACCESSORY DEVICE POLARIS Fig 5 Device Polaris Pos Description A Observation hole B ON OFF button C USB power connector D Lighting head E Movable arm F Fixed arm G Lamp clamping nut H Slit Lamp mount ...

Page 27: ...id negative grid Placido s disk The film once inserted in the lighting head enables to analyze the tear film by means of the reflection visible on the patient s eye surface The image created by the fine or negative grids allows to evaluate the break up time means the tear film break up time The image created by the Placido s disk allows to evaluate the tear film break distortion or irregularity Fi...

Page 28: ...struzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 26 44 3 2 TECHNICAL DATA Technical data Value Mains connector USB Mains power 5V 100mA Light source White LED light Dimensions Height x Length x Depth 217 x 22 x 74 5 mm Weight 300 g Alignment Manual ...

Page 29: ...ial it is prohibited 27 44 4 DEVICE USE 4 1 HOW TO INSTALL THE DEVICE CAUTION Danger of device fall down The device must be correctly installed on the Slit Lamp 1 Turn the lighting head of the slit lamp on the left or on the right oriented with a 90 angle 2 Remove the lid on the slit lamp arm seat Fig 9 Slit lamp lighting head displacement ...

Page 30: ...OLARIS IFU312EN00 This document is the property of CSO Costruzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 28 44 3 Place the lamp mount in the slit lamp arm seat Fig 10 How to place the device ...

Page 31: ... srl Any reproduction even partial it is prohibited 29 44 4 Place the device so that the lighting head faces the patient s eye and the device observation hole is aligned with the microscope shooting channel 5 Turn the device clamp nut to block it to the slit lamp Fig 11 Blocking the device with the clamp nut ...

Page 32: ...i Oftalmici srl Any reproduction even partial it is prohibited 30 44 4 2 HOW TO CONNECT THE DEVICE The device can be powered in two different ways connection with the PC connection with an external power supply How to connect the device to the PC USB port Fig 12 How to connect the device to the PC ...

Page 33: ...document is the property of CSO Costruzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 31 44 How to connect the device to the external power supply USB port Fig 13 How to connect the device to the external power supply ...

Page 34: ...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 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 an...

Page 35: ...ilm shaping it like a cone make sure that the design is in the internal part of the cone 2 Insert the cone within the device lighting system The film shall be completely inserted in the device observation hole Fig 14 Shaping the film like a cone Fig 15 Inserting the film 4 5 HOW TO TURN ON THE DEVICE 1 Turn on the Slit Lamp 2 deactivate the lighting system of the Slit Lamp Refer to the Slit Lamp i...

Page 36: ... Fig 16 ON OFF button The device can be perfectly integrated with the application software Phoenix Refer to the application software and Slit lamp instructions for the image capture and management mode 4 6 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 respectivel...

Page 37: ...document is the property of CSO Costruzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 35 44 Fig 17 Patient position on the chin rest 4 Lift or lower the chin cup as needed Fig 18 Knob rotation Fig 19 Chin cup placement ...

Page 38: ...the patient s eye the shortest the distance between device and eye is the bigger the illuminated area is 3 Set a small magnification Later you can set a bigger magnification to examine the interferometric images and the tear meniscus 4 If necessary bring the image into focus by rotating the oculars for the operator ametropia correction 4 If necessary slightly press the upper arm back or forward to...

Page 39: ...yer this may appear like any of the following amorphous structure marble appearance wavy appearance yellow brown blue or reddish interference fringes Fig 22 Lipid film visualization 4 9 HOW TO ANALYZE THE INFERIOR TEAR MENISCUS HEIGHT 1 Observe the inferior eyelid border to evaluate the produced tear liquid volume Consider the height regularity and shape In case of reflection the evaluation could ...

Page 40: ...line on a normal tear meniscus Fig 24 Normal tear meniscus profile 3 An abnormal tear meniscus presents a lowered and irregular shape near the eyelid margin You will observe a black line near the convex part of the meniscus profil irregular and broken it is typical of the abnormal tear meniscus Fig 25 Black line on an abnormal tear meniscus Fig 26 Abnormal tear meniscus profile ...

Page 41: ...ow to insert the film in the device lighting head at page 33 2 Verify the correct eyes position respectively to the shooting channel 3 Ask the patient to look ahead and open and close the eyes for a few seconds so that the tear film is evenly distributed on the corneal surface 4 Ask the patient to keep the eyes open as long as possible during the exam 5 Check the time between the last patient s bl...

Page 42: ... 33 2 Ask the patient to look ahead and open and close the eyes for a few seconds so that the tear film is evenly distributed on the corneal surface 3 Observe the image reflected on the corneal surface A regular corneal surface will result in a reflected image with concentric rings all at the same distance Any irregularities in the corneal surface of the will result in irregularities of the reflec...

Page 43: ...it Lamp and application software instructions for the image managing mode 4 13 HOW TO TURN OFF THE DEVICE 1 Press the switch on of the device 2 Disconnect the USB connector from the power socket or from the PC Fig 30 ON OFF button 3 Remove the film used for the exam and place it in the device case 4 Rotate the device clamp nut 5 Lift the device from its seat in the slit lamp arm and place it in th...

Page 44: ...INSTRUCTIONS FOR USE POLARIS IFU312EN00 This document is the property of CSO Costruzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 42 44 Fig 31 Clamp nut rotation ...

Page 45: ...e 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 the instructions for use In case of operational faults or malfunctions or for every maintenance operation not mentioned in the instructions for use there is the obligation to address an authorized technical assistance center of the device Manufa...

Page 46: ...convenient Cause Solution Note The device does not switch on Power cable not connected properly Connect the device power cable Press the switch on of the device If 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 Device movement difficulties ahead back Contact the Technical Service Cent...

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Page 48: ...COSTRUZIONE STRUMENTI OFTALMICI phone 39 055 722191 fax 39 055 721557 cso csoitalia it www csoitalia it 4 174 POLARIS IFU312EN00 09 2018 ...

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