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Icare HOME tonometer Instruction manual for health care professionals

ENGLISH

www.icare-usa.com

ICARE FINLAND OY

Äyritie 22, FI-01510 Vantaa, Finland

Icare Finland is the original developer and global leader in handheld tonometry.

Our patented technology (over 20 patents/patent applications) combined with ISO 13485

certified quality system has made us a respected player in our field of expertise.

The advanced Icare® product line offers reliable, high precision, reproducible accuracy in

measuring intraocular pressure in any circumstances, in both experienced and inexperienced

hands. A variety of Icare® tonometers are available for several uses:

Icare

ic100

, Icare

TA01i

, Icare

HOME

, Icare

TONOVET

, Icare

TONOLAB

Made in Finland.

-0

-U

-2

Summary of Contents for HOME

Page 1: ...Icare HOME tonometer Instruction manual for health care professionals ENGLISH 1 www icare usa com INSTRUCTION MANUAL FOR HEALTH CARE PROFESSIONALS ENGLISH...

Page 2: ...obe 10 10 Using the tonometer 12 10 1 Choosing the measurement mode 12 10 2 Adjusting the measurement position 13 10 3 Automatic eye recognition 14 10 4 Taking the measurements 15 11 Reading the measu...

Page 3: ...ssionals must inform patients not to modify or discontinue their treatment plan without receiving instructions from the health care professional WARNING For cybersecurity do not connect to the USB por...

Page 4: ...ns or decreased electromagnetic immunity of this equipment and result in improper operation WARNING Use of this equipment adjacent to or stacked with other equipment should be avoided because it could...

Page 5: ...it is not used Do not carry out any other service procedures than those described in the chapters 10 12 Leave all other service and repairs to the manufacturer or a certified service center Update th...

Page 6: ...following conditions are generally not eligible for use of the HOME tonometer as they have the potential to introduce unsafe conditions during use or to impair measurement acquisition 1 Uncorrected ne...

Page 7: ...e recorded measurement information to a PC through a USB cable 7 PACKAGE CONTENTS WARNING Keep the tonometer out of reach of children because the probe base battery compartment cover and probes are so...

Page 8: ...RY light 20 POWER button 10 Battery cover 11 Silicone lid USB cover 12 Type label 8 Forehead support adjustment wheel 9 Cheek support adjustment wheel FRONT PARTS TOP PARTS BACK PANEL BOTTOM PARTS SID...

Page 9: ...mly and press the silicone lid in place to cover the USB port 9 2 TURNING THE TONOMETER ON PRECAUTION The tonometer turns off automatically after 3 minutes if it is not used Press the power button 20...

Page 10: ...ncorrect measurement values in the breakdown of the probe cross contamination of bacteria or viruses and infection of the eye Re sterilization or re use will void all responsibilities and liabilities...

Page 11: ...probe container upside down 4 Press the measurement button 13 briefly 1 second to activate the probe 5 The probe moves rapidly back and forth 6 See that the Measure light 15 flashes If so the probe is...

Page 12: ...is especially useful for those patients who tend to blink heavily Here you press the measurement button briefly 1 second for each of the six measurements to obtain the final IOP reading see figure le...

Page 13: ...me for the other eye as well unless only one eye needs monitoring 6 Verify that the support positions are correct each and every time the patient comes in for a clinic visit The tonometer has two adju...

Page 14: ...The right hand transmitter sends invisible infrared light to the right and the left hand transmitter to the left The infrared light reflects from your nose to the sensor The sensor knows from which tr...

Page 15: ...til the Measure light illuminates again 3 The patient should look straight ahead at a specific point while keeping eyes wide open as shown in the below figure 4 Bring the tonometer near the eye the pr...

Page 16: ...easure button briefly 1 second and continue the measurement See also section 9 Trouble shooting 8 Press the power button for three seconds to turn the tonometer off The probe slides out of the probe b...

Page 17: ...every complete measurement sequence of six measurements The stored information includes the calculated final eye pressure reading in mmHg time and date of the measurement identification of the eye rig...

Page 18: ...8mm 5 32 5 16 between the probe tip and the center of the cornea b Set the probe perpendicular to the center of the cornea Repeat light is flashing and Probe base light is flashing red Two long error...

Page 19: ...RE REPEAT DONE SERVICE BATTERY LOAD MEASURE REPEAT DONE SERVICE BATTERY LOAD MEASURE REPEAT DONE SERVICE BATTERY LOAD MEASURE REPEAT DONE SERVICE BATTERY LOAD MEASURE REPEAT DONE SERVICE BATTERY LOAD...

Page 20: ...ainer with 70 100 isopropyl alcohol Turn the power off Unscrew the probe base collar Invert the probe base over the container drop in the probe base into the container and let soak for 5 30 minutes Re...

Page 21: ...ometrically by an attached calibrated pressure sensor as reference The measurements were taken using the Icare HOME and additionally verified by a reference tonometer Differences between Icare HOME an...

Page 22: ...dy staff then acquired three measurements on the Icare TA01i tonometer then an eye care professional took two GAT measurements a third if the first two were not within 2 mm Hg of each other Other test...

Page 23: ...meter after training and failed to complete the certification procedures described in the protocol The reasons for failing certification were three Home readings differed by 7mmHg 0 7 the first Home r...

Page 24: ...atoconus Any other corneal or conjunctival pathology or infection Central corneal thickness greater than 0 60 mm or less than 0 50 mm in the study eye Inability to demonstrate proficiency with Icare H...

Page 25: ...ort Not Spanish Hispanic Latin o Mexican Mexican Am Chicano Puerto Rican Other Spanish Hispanic Latino Handedness Right Left Ambidextrous Study Eye OD Right OS Left IOP Group 16 mmHg 16 to 23 mmHg 23...

Page 26: ...Agreement between Home and Reference Effectiveness Analysis Cohort N is the number of eyes with measurements from both devices Difference HOME Reference 95 confidence interval CI for mean difference i...

Page 27: ...of each study eye was used in the analysis The Mean Median of GAT was used in the analysis the median was used if the eye had three measurements Otherwise the mean was used if the eye had two measure...

Page 28: ...HOME measurements to four plus the one GAT certification measurement the number of eyes experiencing an increase in staining increased to 11 3 however only five 1 3 eyes experienced a clinically signi...

Page 29: ...r on the order of a physician Rx Only IP22 Sterilized using irradiation Stand by Do not discard this product with other household type waste Send to appropriate facility for recovery and recycling EU...

Page 30: ...1 2 Edition 4 0 2014 02 Electromagnetic emissions Icare HOME TA022 is intended for use in a home healthcare environment with electromagnetic characteristics specified below The user of the Icare HOME...

Page 31: ...line s to earth Not applicable Icare HOME TA022 tonometer is not operational when connected to an external computer Icare HOME TA022 batteries are not rechargeable Voltage dips short interruption and...

Page 32: ...able RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the Icare HOME TA022 including cables s...

Page 33: ...0 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 2570 MHz 28 V m PM 50 217...

Page 34: ...s green if the tonometer s position is horizontal enough otherwise it is red Explain that if there is an error in your measurement the probe base light flashes red and you hear two long error beeps Re...

Page 35: ...nts straight at cornea Make sure probe base light is green If probe base light is red make sure you are facing straight ahead i e head held at a 90 angle and tilt tonometer until probe base light turn...

Page 36: ...rements tab opens showing the copied results with date and time information that all is now stored to the PC STEP 3 Rehearsal 1 Position the tonometer on your HCP trainer own eye 2 3 measurements as i...

Page 37: ...f use of the device if the following conditions are met a The reading taken by the trainer and the rst of the three readings taken by the HCP di er by 5 mmHg or less b The range max min of the three r...

Page 38: ...rement At the same time the probe eye recognition system could not recognize the eye because of the incorrect position of the tonometer and you hear a long beep and the probe base light goes out the m...

Page 39: ...n If the probe is not centered in your sight repeat steps 5 and 6 be tilted more than 10 degrees away from the center of the cornea 5 Explain how to take the measurement to measure IOP result and that...

Page 40: ...t 2 Both English Icare HOME tonometer Instruction manual for health care professionals STEP 3 Supervised patient use of the icare home 1 Load a new probe and carefully without touching the patient s e...

Page 41: ...retonometer com 41 Icare HOME English Icare HOME tonometer Instruction manual for health care professionals Icare HOME tonometer Instruction manual for health care professionals ENGLISH 41 www icare u...

Page 42: ...patent applications combined with ISO 13485 certified quality system has made us a respected player in our field of expertise The advanced Icare product line offers reliable high precision reproducib...

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