Icare tonometer one User And Maintenance Manual
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Icare tonometer one User And Maintenance Manual

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ENGLISH
USER'S AN D M AI N TEN AN CE M AN UAL

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Summary of Contents for Icare Icare tonometer one

  • Page 1 ENGLISH USER’S AN D M AI N TEN AN CE M AN UAL...

  • Page 2: Table Of Contents

    The device probe tips have not been evaluated for the presence of endotoxins. The probe tips are for single-use only, and are packaged sterile. WARNING! The Icare ONE Tonometer (TA02) is intended to be used only under supervision and control of the health care professional only. www.icaretonometer.com...

  • Page 3: Indications For Use

    INDICATIONS FOR USE Icare ONE tonometer (TA02) is indicated for the monitoring of intraocular pressure (IOP) of the human eye. It is intended to be used by health care professionals and by patients under supervision and control of the health care professional. Patient use is by prescription only.

  • Page 4: Usage Contraindications

    Icare ONE tonometer can be used by glaucoma patients to monitor their intraocular pressure. Results are stored in the internal memory of the tonometer and can be transferred to a PC through a USB cable using the Icare LINK software. Consult your doctor to interpret the results of the self-measurement.

  • Page 5: Turning The Device On

     English Icare tonometer ONE manual 1. Eye support 2. Support position indicator 3. Measurement button 4. Forehead support 5. Probe 6. Cheek support 7. Probe base 1. IOP indicator LEDs 2. Mode switch 3. Forehead/cheek support adjustment wheel 4. PROBE ERROR LED 5.

  • Page 6: Setting Up The Tonometer Before Taking Measurements

     English Icare tonometer ONE manual Accuracy of display: display is divided into 11 ranges:  5-7 mmHg  7-10 mmHg  10-14 mmHg  14-18 mmHg  18-21 mmHg  21-24 mmHg  24-27 mmHg  27-30 mmHg ...

  • Page 7: Loading The Probe

    Forehead and eye support, with the cheek support in minimum position LOADING THE PROBE The Icare ONE tonometer TA02 uses disposable tonometer probes as shown in figure. Each probe is meant for single use only. The probes are packed individually in blister.

  • Page 8: Measuring Intraocular Pressure

    In addition to showing the IOP range, the accurate IOP value is stored in the internal memory. Icare ONE is constantly controlling the measurement position. When too far or near from eye or if the measurement angle is too tilted, the tonometer beeps twice and displays a red LED indicating an error (Position).

  • Page 9: Patient Use Instructions

    The tonometer’s internal memory stores the time and date of a measurement, the measurement result and the quality level of the measurement. This information can be uploaded to a PC through a USB cable using Icare® LINK software. The tonometer is taken to a health care professional who can transfer the data.

  • Page 10: Error Messages And Indicators

    NOTE: When using Icare LINK software, it assumes by default that the first accepted measurement is for the right eye and the second accepted measurement is for the left eye. In case you end up taking multiple measurements for some reason, the eye details can be incorrect and must be fixed (See Icare LINK user manual).

  • Page 11: Cleaning And Disinfection

     English Icare tonometer ONE manual CLEANING AND DISINFECTION The forehead and cheek supports and the eye support must be cleaned for each new patient with disinfectant for example 70% alcohol solution using wipe. Do not immerse the tonometer in water or other liquid.

  • Page 12: Service Procedures

    Mode switch key  USB cable  Batteries  carry on case These can be purchased from a local distributor of Icare products. TECHNICAL AND PERFORMANCE DATA  Type TA02  The device conforms to CE regulations  Dimensions: approximately 11 cm x 8 cm x 3 cm ...

  • Page 13: Clinical Performance Data

    Performance data is obtained from a clinical study, performed according to ANSI Z80 and ISO 8612 for tonometers. The mean of paired difference (Goldmann-Icare ONE tonometer) were 0.6 (≤16 mmHg 0.1; >16<23 1.0; ≥23 0.8) and and standard deviation is 3.1...

  • Page 14: Symbols

     English Icare tonometer ONE manual SYMBOLS  Caution  Keep dry  See operating instructions  Manufacturing date for more information   BF-type device Lot number   Single-use disposable Sterilized using irradiation   Serial number Stand by ...

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