Icare HOME2 User Manual Download

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ENGLISH

Instruction Manual

iCare

HOME2

Rx Only (U.S.)

Summary of Contents for HOME2

Page 1: ...ENGLISH Instruction Manual iCare HOME2 Rx Only U S...

Page 2: ...property of their respective owners Made in Finland Android is a registered trademark or trademark of Google Inc Google Play is a trademark of Google LLC App Store is a trademark of Apple Inc The Blu...

Page 3: ...ct measurement position 17 8 4 Adjust the supports and position the tonometer 18 8 5 Measure your eye pressure 20 8 6 Measure your eye pressure in the supine position 22 8 7 Errors during the measurem...

Page 4: ...36 17 Technical information 37 17 1 Technical description 37 17 2 System requirements for iCare CLINIC 37 17 3 IT network specifications 38 17 4 Intended information flow 38 17 5 Potential hazardous s...

Page 5: ...healthcare professional WARNING The tonometer must not be dropped To avoid dropping the tonometer and to ensure safe handling always use the wrist strap to keep the tonometer attached to your wrist w...

Page 6: ...e tonometer in liquid Do not spray pour or spill liquid on the tonometer its accessories connectors switches or openings in the cover Immediately remove any liquid from the surface of the tonometer WA...

Page 7: ...recognition may be interfered PRECAUTION To ensure the correct functioning of the tonometer change the probe base every six months PRECAUTION Non ME equipment computer or mobile device used in the sy...

Page 8: ...software system If the essential performance of the tonometer is lost or degraded due to electromagnetic disturbances the tonometer continuously displays error messages during the measurement and asks...

Page 9: ...eligible for use of the iCare HOME2 tonometer if you have poor uncorrected near vision of 20 200 or worse have only one working eye have poor or off center visual fixation have poor hearing without a...

Page 10: ...w the measurement data iCare CLINIC On premises a version of iCare CLINIC that can be installed on a hospital s or clinic s own server With iCare CLINIC On premises the measurements cannot be viewed f...

Page 11: ...urements is 3 6 times a day Keep a record of your eye pressure for your healthcare professional A single measurement does not provide accurate information on your eye pressure level You need to take a...

Page 12: ...anuals Probe applicator Quick Guides Screwdriver Torx TX8 Spare probe base Sterilized single use probes USB C to Micro USB B adapter USB cable for PC connection USB C to USB A USB cable for mobile dev...

Page 13: ...ng the safety and effectiveness of the tonometer 1 2 5 3 4 8 9 10 11 12 12 14 13 15 16 6 7 1 Measure button 2 Navigation buttons 3 Select button 4 Return button 5 Display 6 Battery cover 7 USB C port...

Page 14: ...er or the distributor of the tonometer 7 1 Insert the batteries WARNING Remove the batteries from the tonometer if it is not likely to be used for some time PRECAUTION Use only the battery type specif...

Page 15: ...o not use probes without a plastic tip Do not use deformed probes Contact the manufacturer or local distributor if you notice faulty probes or probe packages WARNING Use only original and certified pr...

Page 16: ...16 2 Place the probe applicator over the probe base 3 Open the packaging 4 Remove the cap 5 Drop the probe from the container to the probe applicator 6 Remove the probe applicator...

Page 17: ...he iCare EXPORT software Press down until you hear a beep The text Start is shown on the display OR 3s 3s Alternatively press down until you hear a beep Then press again to enter the measurement mode...

Page 18: ...difference of infrared reflections received from the transmitters the nose side reflects more than the temple side If the transmitters become dirty the recognition may be interfered PRECAUTION Do not...

Page 19: ...ter against your face and look into the probe base START The probe points perpendicularly to the center of your eye when the blue and green rings in the probe base are symmetrical 4 If the rings are n...

Page 20: ...n ring The tonometer is now at the correct distance from your eye START 5 mm 0 2 inches 8 5 Measure your eye pressure 1 Start the measurement when you see only a symmetrical green ring Press the Measu...

Page 21: ...urement sequence consists of six measurements 6x NOTE You can also take the measurement sequence by pressing and holding the Measure button down until all six measurements have been taken 5 When all s...

Page 22: ...ght ahead Avoid bending your head and neck backwards 2 Place the tonometer at a 90 degrees angle on your face and take the measurement as as instructed in 8 5 Measure your eye pressure START NOTE Befo...

Page 23: ...ter so that the probe points perpendicularly to the center of your eye Keep your eye properly open REPEAT 2 short beeps The probe did not move properly or did not make a clean contact with the cornea...

Page 24: ...tem The measurement quality is an indication of how much variation there was between the six individual measurement results The measurement quality indication green or yellow is not related to the lev...

Page 25: ...ou hear 3 beeps and the display turns off The tonometer turns off if you don t use it for three minutes 3s Remove the probe and put it back to the probe container Dispose of the probe and container in...

Page 26: ...e With the iCare CLINIC software the healthcare professional can set the tonometer to the rental mode which allows the healthcare professional to set a rental time for the tonometer During the rental...

Page 27: ...3 Press or until you see the time format you want and press 4 Press or until you see the time zone you want and press 5 Press or until you see the hour you want and press 6 Press or until you see the...

Page 28: ...ce with which the healthcare professionals and patients can view the measurement data iCare PATIENT2 mobile application with which the patients and healthcare professionals can view measurement data a...

Page 29: ...e IT network is in chapter 17 3 IT network specifications 12 2 Install the software Before the healthcare professional or the patient can start transferring data from the tonometer to the iCare CLINIC...

Page 30: ...ot use the USB connection Use the Bluetooth connection instead USB C Micro USB USB A USB C 1 Open the iCare EXPORT software on your computer or the iCare PATIENT2 application on your mobile device 2 C...

Page 31: ...nd you need to start it from the beginning 9 When you see BLUETOOTH CONNECTED on the tonometer display press 10 Follow the instructions shown on your mobile device or computer 12 4 Bluetooth notificat...

Page 32: ...the pairing Press to acknowledge the notification and repeat the pairing process from the start SERVICE ID Internal error Write down the service ID shown on the display Switch off the tonometer Conta...

Page 33: ...amage keep the tonometer out of the reach of children and pets The probe base battery cover screws collar and probes are small objects and may be accidentally swallowed WARNING Do not change the batte...

Page 34: ...re USA 14 2 Clean and disinfect the tonometer WARNING Never immerse the tonometer in liquid Do not spray pour or spill liquid on the tonometer its accessories connectors switches or openings in the co...

Page 35: ...n normal use The performance of the batteries may vary depending on the battery brand and model 14 4 Return the tonometer for service or repair NOTE Before contacting for service write down the serial...

Page 36: ...e base a replaceable part that guides the probe s movement during measurements Probe base light colored light rings or a solid light help you place the tonometer correctly on your face Shelf life the...

Page 37: ...F Relative humidity 30 to 90 Atmospheric pressure 800 hPa to 1 060 hPa Storage environment Temperature 10 C to 55 C 14 F to 131 F Relative humidity 10 to 95 Atmospheric pressure 700 hPa to 1 060 hPa T...

Page 38: ...meter connected to IT networks including other equipment PRECAUTION Changes to the IT network could introduce new risks requiring additional analysis by the responsible organization The changes includ...

Page 39: ...ither diagnosed glaucoma patients or glaucoma suspects A random eye was selected as the study eye for each patient Safety No adverse events including corneal abrasions were recorded in the study popul...

Page 40: ...cibility was assessed by a test in which two operators performed three measurements with three different iCare HOME2 tonometers Three different pressure levels 7 10 20 30 40 and 50 mmHg and three diff...

Page 41: ...cian or properly licensed practitioner Bluetooth communication The Regulatory Compliance Mark RCM in Australia and New Zealand Technical conformity mark and certification number of the Ministry of Int...

Page 42: ...equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there...

Page 43: ...nce In such case reconnect the tonometer to the computer or mobile device If this does not solve the issue perform the data transfer in other location with no such interference The measurement data wi...

Page 44: ...l fast Transients burst IEC 61000 4 4 2 kV 100 kHz repetition frequency NOT APPLICABLE NOT APPLICABLE Surge IEC 61000 4 5 1 kV for line s to line s 2 kV for line s to earth NOT APPLICABLE NOT APPLICAB...

Page 45: ...5 MHz and 80 MHz 80 AM at 1 kHz 3 V 6 V WARNING Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to...

Page 46: ...ent IEC 61000 4 3 380 390 MHz 27 V m PM 50 18 Hz 430 470 MHz 28 V m FM 5 kHz 1 kHz sine PM 18 Hz 704 787 MHz 9 V m PM 50 217 Hz 800 960 MHz 28 V m PM 50 18 Hz 1700 1990 MHz 28 V m PM 50 217 Hz 2400 25...

Page 47: ...47...

Page 48: ...brochure are approved or offered in every market and approved labeling and instructions may vary from one country to another Product specifications are subject to change in design and scope of deliver...

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