icare HOME TA022 Patient Manual
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icare HOME TA022 Patient Manual

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1
PATIENT
GUIDE
ENGLISH
Federal (US) law restricts this device to
sale by or on the order of a physician
or properly licensed practitioner.
Belongs to:

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Summary of Contents for icare HOME TA022

  • Page 1 www.icare-usa.com PATIENT GUIDE ENGLISH Federal (US) law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Belongs to:...

  • Page 2: Table Of Contents

    Icare HOME (Model: TA022) PATIENT GUIDE TA022-035-USA-3.1 This device complies with: Medical Device Directive 93/42/EEC Canadian Medical Device Regulations RoHS Directive 2011/65/EU Copyright © 2019 Icare Finland Oy Copyright © 2020 Icare Finland Oy Made in Finland Made in Finland Icare Finland Oy Äyritie...

  • Page 3: Safety Instructions

    Icare HOME Patient Guide ENGLISH SAFETY INSTRUCTIONS WARNING! You should not use the device in areas with a high noise level where sound error codes cannot be heard. WARNING! Do not push the tonometer into the eye (never use a probe that has no plastic tip).
  • Page 4 Remove any liquid appearing on the surface of the tonometer at once. WARNING! The Icare HOME tonometer is indicated for use only under supervision of a health care professional. WARNING! The tonometer should only be opened by qualified service personnel.
  • Page 5 WARNING! Sources of power frequency magnetic field should be used no closer than 15 cm (6 inches) to any part of Icare HOME (TA022), including cables specified by the manufacturer. Otherwise, degradation of the performance could result.
  • Page 6 • Check that the silicone lid covers the USB port during the measurement. • The measurement method of the Icare HOME tonometer is based on magnetic induction and therefore an external magnetic field in line with the probe may prevent the measurement.

  • Page 7: Glossary

    INTRODUCTION This guide will teach you how to use the Icare HOME tonometer. The Icare HOME tonometer is a prescription device intended as an adjunct to the routine clinical monitoring of intraocular pressure (IOP) of adult patients.

  • Page 8: Contraindications

    Icare HOME Patient Guide ENGLISH The probe is disposable. You can use the same probe for both eyes if the health care professional instructed you to measure both eyes. After you have taken the measurements for both eyes, dispose the probe in a mixed waste bin.

  • Page 9: Risks

    • Have a congenitally (from birth) small eye • Have an enlarged eye from childhood glaucoma • Had a cataract removed within last 2 months The safety and effectiveness of the Icare HOME tonometer has not been evaluated for patients with: •...

  • Page 10: Tonometer Overview

    Icare HOME Patient Guide ENGLISH TONOMETER OVERVIEW FRONT Cheek support adjustment wheel BACK Measure button LOAD indicator MEASURE indicator REPEAT indicator DONE indicator SERVICE indicator BATTERY indicator Power button...
  • Page 11 www.icare-usa.com Forehead support adjustment wheel Forehead support Eye recognition sensors (Detect which eye is measured) Probe base (with indicator light) Probe Cheek support BOTTOM Cheek support position indicator Cheek support adjustment wheel Silicone lid (USB cover) Battery cover...

  • Page 12: Preparing The Tonometer For Use

    Icare HOME Patient Guide ENGLISH PREPARING THE TONOMETER FOR USE Make sure the forehead and cheek support positions match the positions your eye care professional wrote on the support postion tag for you. The support position tag is found in the carrying case.
  • Page 13 www.icare-usa.com...

  • Page 14: Positioning The Tonometer

    Icare HOME Patient Guide ENGLISH POSITIONING THE TONOMETER Hold the tonometer in front of your eye with the forehead and cheek supports against your face. Make sure that the probe base light is visible. WARNING Make sure that the probe or any part of the tonometer does not contact your eyes.
  • Page 15 www.icare-usa.com Green indicator light Red indicator light Correct Slightly Slightly position tilted tilted horizontally vertically...

  • Page 16: Completing The Measurement

    Icare HOME Patient Guide ENGLISH COMPLETING THE MEASUREMENT Press the Measure button to measure pressure (probe will contact eye during measurements). Press and hold down the Measure button until you hear a long beep to collect 6 measurements in a row or press the Measure button 6 individual times to collect each measurement separately.
  • Page 17 www.icare-usa.com Steps 1-10...

  • Page 18: Troubleshooting

    Icare HOME Patient Guide ENGLISH TROUBLESHOOTING ERROR MESSAGE Probe base indicator light is solid red. Cause: Tonometer is not held straight. Probe base indicator light is flashing red and you hear: 2 beeps - Tonometer is not correctly aligned or probe hit eyelid or eyelash.
  • Page 19 www.icare-usa.com SOLUTION Make sure you are facing straight ahead (i.e., head held at a 90° angle). Adjust the tonometer’s tilt angle until probe base light turns green. Press the Measure button to clear error. Adjust the forehead/cheek supports for correct distance if needed. Set the probe perpendicular to the center of the cornea.

  • Page 20: Replacing The Batteries

    Icare HOME Patient Guide ENGLISH REPLACING THE BATTERIES Lift silicone lid from battery cover then slide battery cover open. Remove used batteries and insert 2 new CR123A lithium batteries. Make sure the batteries’ positive end (+) is facing the battery cover.
  • Page 21 www.icaretonometer.com www.icare-usa.com USB port USB port Adjustment wheel Adjustment wheel Silicone lid Silicone lid Probe base Probe base collar...

  • Page 22: Cleaning The Tonometer

    Icare HOME Patient Guide ENGLISH CLEANING THE TONOMETER Slightly dampen a cloth or paper towel with water. Make sure to remove excess water from the cloth or paper towel. Clean the tonometer with the damp cloth or paper towel. WARNING Do not immerse the tonometer in water or any other liquid.
  • Page 23 www.icare-usa.com...

  • Page 24: Clinical Performance Data

    CLINICAL PERFORMANCE DATA A study was conducted with 383 patients performing self-measurements with the Icare HOME tonometer. A summary of the study findings are below: • No complications (including corneal abrasions) were recorded. • The eye pressure ranges measured were ≤16 mmHg, >16 to <23 mmHg and ≥23 mmHg...

  • Page 25: Lifetime

    12 months. The life time of the batteries is about 5000 measurements. TECHNICAL DATA Type: TA022 Dimensions: approximately 11cm x 8cm x 3cm Weight: approximately 150g Power supply: 2 x CR123 non-rechargeable batteries (make sure you use batteries with built-in...

  • Page 26: Symbols

    Icare HOME Patient Guide ENGLISH Operation environment: Temperature: +10 °C to +35 °C Relative humidity: 30% to 90% Atmospheric pressure: 800hPa – 1060hPa Storage environment: Temperature: -10 °C to +55 °C Relative humidity: 10% to 95% Atmospheric pressure: 700hPa – 1060hPa...
  • Page 27 www.icare-usa.com Use by <date> Manufacturing date Manufacturer Lot number Stand by Do not discard this product with IP22 other household-type Protected against waste. Send to insertion of fingers appropriate facility and will not be for recovery and damaged or become recycling.

  • Page 28: Electromagnetic Declaration

    Guidance and manufacturer’s declaration IEC 60601-1-2: 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 (TA022) should assure that it is used in such an environment.
  • Page 29 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 user of the Icare HOME (TA022) should assure that it is used in such an environment.
  • Page 30 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 user of the Icare HOME (TA022) should assure that it is used in such an environment.

  • Page 31: Getting Support

    www.icare-usa.com GETTING SUPPORT If you have any questions or problems using the Icare tonometer, call the service center: (toll-free) 888-422-7313 or email: service@icare-usa.com or visit Icare at: www.icare-usa.com. Please, check the instructions manual for further information. Place other appropriate contact information of the supplier of the device or other source of supplies here:...
  • Page 32 Icare HOME Patient Guide ENGLISH 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.

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