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Icare HOME Instruction Manual
Summary of 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: Table of Contents
Icare ® home (model: ta022) instruction manual ta022-036 en-3.2 icare ® home (model: ta022) instruction manual ta022-036 usa-2.0 the information in this document is subject to change without prior notice. In a conflict situation the english version prevails. This device complies with: medical device...
Page 3: 1. Safety Instructions
Www.Icaretonometer.Com 3 icare home 1. Safety instructions warning! Do not push the tonometer into the eye (the tip of the probe should be 4-8mm, or 5/32-5/16” , from the eye). Warning! Keep the tonometer out of the reach of children, because the probe base, battery compartment cover and probes are ...
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Www.Icaretonometer.Com english icare home tonometer instruction manual for health care professionals icare home 4 warning! Federal (us) law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Warning! Use only the original and certified probes made by t...
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Www.Icaretonometer.Com 5 icare home precaution! • the tonometer conforms to emc requirements (iec 60601-1-2), but interference may occur within the tonometer if used near ( electromagnetic emissions, such as a cellular phone. Although the tonometer’s own electromagnetic emissions are well below the ...
Page 6: 2. Indications For Use
Www.Icaretonometer.Com 6 english icare home tonometer instruction manual for health care professionals 2. Indications for use the icare home tonometer is a prescription device intended as an adjunct to the routine clinical monitoring of intraocular pressure (iop) of adult patients. 3. Contraindicati...
Page 7: 6. Introduction
Www.Icaretonometer.Com 7 icare home english icare home tonometer instruction manual for health care professionals 6. Introduction the icare home tonometer is a hand-held device for self-use. The tonometer uses the rebound method. A small and light single-use probe makes contact with the eye very bri...
Page 8: Front Parts
Www.Icaretonometer.Com 8 icare home load measure repeat done service battery 1. Probe base incorporating indicator light 2. Eye recognition transmitter 3. Eye recognition sensor 4. Cheek support 5. Forehead support 6. Measurement button 7. Forehead support position indicator 13. Measurement button 1...
Page 9: 9.2
Www.Icaretonometer.Com 9 precaution! Make sure you use batteries with built-in ptc protection, for example energizer lithium photo 123 3v cr123a. Update the tonometer’s time to your local time. It is done automatically by performing the steps 1 and 2 under section 8. Reading the measurement data. Li...
Page 10: 9.3
Www.Icaretonometer.Com 10 icare home precaution! The patient should be instructed to thoroughly wash and dry their hands with soap and a clean towel prior to handling the probe. Warning! To prevent contamination, do not touch the bare probe, do not use a probe if it touches a non-sterile surface lik...
Page 11: To Load The Probe:
Www.Icaretonometer.Com 11 english load measure repeat done service battery loa easu lo eas 1. Unwrap the probe. 2. Remove the lid of the probe container as shown in the figure above. Point the tonometer upward. 3. Drop the probe into the probe base (1) by turning the probe container upside down. 4. ...
Page 12: 10.
Www.Icaretonometer.Com 12 icare home series mode the series mode is especially useful in self-tonometry. In the series mode, keeping the button pressed down (see figure left) initiates the measurement function, and the tonometer takes six rapid measurements one after the other to obtain the final io...
Page 13: 10.2
Www.Icaretonometer.Com 13 to adjust the measurement position for your patient: 1. Adjust the supports using the adjustment wheels as shown in the above figure. 2. Keep the probe horizontal and pointing perpendicularly to the center of the cornea. 3. Set the distance between the tip of the probe and ...
Page 14: Eye Recognition Components
Www.Icaretonometer.Com 14 icare home precaution! Do not cover the eye recognition transmitters or sensor during the measurement, for example with fingers. Keep your hand, hair etc. And objects such as pillows away from the temple side of your eye, as they produce an infrared reflection that causes a...
Page 15: 90°
Www.Icaretonometer.Com 15 warning! Do not push the tonometer into the eye (the tip of the probe should be 4-8mm, or 5/32-5/16”, from the eye). Warning! The probe should be replaced if it contacts or is suspected of having contacted the eyelashes or eyelid such as might occur during a blink. The prob...
Page 16
Www.Icaretonometer.Com 16 icare home 5. Press the measurement button: single mode: press the button briefly (1 second) and you hear a short beep, repeat it to take one measurement at a time till you hear a long beep and see the done light (17) illuminated on the back panel. Series mode: keep the mea...
Page 17: Uploading Is Easy:
Www.Icaretonometer.Com 17 english more information about icare link software http://www.Icaretonometer.Com/products/icare-link/ link connected warning! For cybersecurity do not connect to the usb port except when uploading patient measurement data using the icare link software or when upgrading the ...
Page 18: 12.
Www.Icaretonometer.Com 18 icare home the tonometer automatically monitors and controls the measurement position and speed of the probe during the measurements, and indicates errors with sounds and lights. The following table instructs you in error situations and explains what the different lights an...
Page 19
Www.Icaretonometer.Com 19 off intialize load probe measure repeat done service low battery empty 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 measure repeat done servic...
Page 20: 14. Cleaning The Probe Base
Www.Icaretonometer.Com 20 icare home done service low battery empty battery icare home tonometer instruction manual for health care professionals 13. Replacing the probe base replace the probe base every twelve months. Replace or clean the probe base if the service light flashes. Instructions for re...
Page 21: 17. Lifetime
Www.Icaretonometer.Com 21 icare home 17. Lifetime the expected service life of the device is 5 years. The maintenance described in the chapters 10-12 is required during the the expected service life. The shelf life of the probes in their intact original packaging is 3 years. We also recommend that y...
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Www.Icaretonometer.Com 22 icare home • medivac vehicles or similar where vibration or noise levels are so high that theuser cannot hear error signals. Environmental restrictions for lay operators (patients): • environments where noise is so high that the user cannot hear the error signals. Mode of o...
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23 icare home icare home tonometer instruction manual for health care professionals english (~10% for each bin) and smaller for the high iop range (~7.5%). No adverse events (including corneal abrasions) were recorded in this study population of 383 eyes. Only certified users were able to proceed to...
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Www.Icaretonometer.Com 24 icare home icare home tonometer instruction manual for health care professionals english • high corneal astigmatism >3d in the study eye(s) based on their current refractive prescription if available. Those without a prescription will undergo auto-refraction to obtain kerat...
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Www.Icaretonometer.Com 25 icare home icare home tonometer instruction manual for health care professionals english table 2 provides descriptive statistics for the iop measurements from the icare home, gat, and ta01i. Table 2. Descriptive statistics of iop measurements (effectiveness analysis cohort)...
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Www.Icaretonometer.Com 26 icare home icare home tonometer instruction manual for health care professionals english table 3 provides the limits of agreement between the home tonometer and the two reference tonometers. All ansi performance goals were met as less than 5% of measurements fell outside ± ...
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Www.Icaretonometer.Com 27 icare home icare home tonometer instruction manual for health care professionals english cct home gat difference 95% ci for mean 95% loa for mean outside ± 5 mmhg outside ± 7.5 mmhg group n mean (sd) mean (sd) mean (sd) difference difference n (%) n (%) 500-520 94 17.43 (5....
Page 28: 19.
Www.Icaretonometer.Com 28 icare home icare home tonometer instruction manual for health care professionals english safety: no adverse events (including corneal abrasions) were recorded in this study population of 383 eyes. Anterior corneal epithelial grading was performed at baseline and after each ...
Page 29: 19.
Www.Icaretonometer.Com 29 icare home keep dry manufacturing date lot number sn sterile r lot storage environment transport environment temperature limits humidity limits atmospheric pressure limits -10°c 55°c 95% 10% 1060hpa 700hpa -40°c 70°c 95% 10% 1060hpa 500hpa class 1 led product english icare ...
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Www.Icaretonometer.Com 30 warning! Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. War...
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Www.Icaretonometer.Com 31 icare home guidance and manufacturer’s declaration iec 60601-1-2: edition 4.0; 2014-02 - electromagnetic immunity icare home (ta022) is intended for use in a home healthcare environment with electromagnetic characteristics specified below. The customers or users of icare ho...
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Www.Icaretonometer.Com 32 icare home icare home tonometer instruction manual for health care professionals english guidance and manufacturer’s declaration iec 60601-1-2: edition 4.0; 2014-02 – electromagnetic immunity icare home (ta022) is intended for use in a home healthcare environment with elect...
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Icare home tonometer instruction manual for health care professionals english www.Icaretonometer.Com 33 icare home guidance and manufacturer’s declaration iec 60601-1-2: edition 4.0; 2014-02 – electromagnetic immunity icare home (ta022) is intended for use in a home healthcare environment with elect...
Page 34: Providers (Hcp)
Www.Icaretonometer.Com 34 appendix 1. Icare home tonometer training procedures for certification of health care providers (hcp) all health care providers must receive training from a certified trainer and be certified prior to performing tonometry or training others to perform self- measurement tono...
Page 35
Www.Icaretonometer.Com 35 icare home 2. Turning the tonometer on: • press the power button. All indicator lights on the back panel will flash once and you will hear a short beep. • the load light will flash alone when the tonometer is ready to load the probe. • the tonometer turns off automatically ...
Page 36
Www.Icaretonometer.Com 36 7. Show and explain how to collect, display and store the results (for hcps only): • • connect the tonometer to the pc using the usb cable. The load and • pc’s time by the icare link software at this point). • • copy the results to a selected patient (it can be the default ...
Page 37
Www.Icaretonometer.Com 37 icare home 1. Load a new probe and ask the same hcp to measure his/her own iop three times in each eye with the same tonometer used in the reference measurement. 2. Observe if the positioning is correct. Do not supervise or interact. Step 6 – certification connect device to ...
Page 38: For Self-Use
Www.Icaretonometer.Com 38 appendix 2. Icare home tonometer training procedures for certification of the patient for self-use and measurements. Reasons for certification failure. Step 1 – instruct the patient 1. Show and explain the tonometer’s user interface, including icons and status indicators: pr...
Page 39
Www.Icaretonometer.Com 39 icare home 3. The hcp loads the probe: • unwraps the probe. • • drops the probe into the probe base without touching the probe by holding the probe container. • the probe. 4. Explain and show illustrations for how to position the tonometer (use a separate illustration sheet...
Page 40
Www.Icaretonometer.Com 40 step 4 – self-measurement by the patient 1. The same icare home tonometer. 2. Do not supervise or interact. Step 5 – measurement of patient’s iop by hcp 1. The hcp measures the iop of the patient once with the gat tonometer. Step 6 – certification are met: a. B. Or less. C. ...
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Www.Icaretonometer.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-usa.Com.
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Icare home tonometer instruction manual for health care professionals english 42 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) comb...