Icare HOME2 Instruction Manual
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Icare HOME2 Instruction Manual

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iCare
HOME2
ENGLISH
Instruction Manual
Rx Only (U.S.)

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Summary of Contents for Icare HOME2

  • Page 1 HOME2 ENGLISH Instruction Manual Rx Only (U.S.)
  • Page 2 Google LLC. App Store is a trademark of Apple Inc. The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Icare Finland Oy is under license. Other trademarks and trade names are those of their respective owners.

  • Page 3: Table Of Contents

    Volume settings ................27 11.5 Probe base light settings .............. 28 11.6 Display brightness settings ............28 11.7 Tonometer’s serial number and firmware version ....28 12 iCare software system ................28 12.1 Compliancy standards..............29 12.2 Install the software ................ 29...
  • Page 4 12.3 Transfer measurement data to iCare CLINIC or iCare CLOUD .. 12.4 Bluetooth notifications and errors ..........31 13 Troubleshooting ..................32 14 Maintenance ....................33 14.1 Replace the probe base ..............33 14.2 Clean and disinfect the tonometer ..........34 14.3...

  • Page 5: Safety Information

    WARNING! Only probes are intended for contacting the eye. Avoid touching the eye with other parts of the tonometer. Do not push the tonometer into the eye. WARNING! If you need help in using the iCare HOME2 tonometer, contact your healthcare professional.
  • Page 6 Do not take any measurements when the USB cable is connected. WARNING! The tonometer should only be opened by qualified iCare service personnel. The tonometer does not contain any user-serviceable parts, apart from the batteries and the probe base.
  • Page 7 PRECAUTION! Before taking measurements, update the tonometer’s time to your local time manually from the tonometer’s settings or automatically by connecting the tonometer to the iCare PATIENT2 application or to the iCare EXPORT software. PRECAUTION! Do not cover the eye recognition transmitters or sensor during the measurement, for example with your fingers.

  • Page 8: Intended Use

    Intended use The iCare HOME2 tonometer is a prescription device intended as an adjunct to the routine clinical monitoring of intraocular pressure (IOP) of adult patients. Clinical benefits With the iCare HOME2 tonometer, you can measure your eye pressure at various times during the day and night.

  • Page 9: Restrictions Of Use

    (blepharospasm) • have involuntary, rapid, and repetitive movement of the eyes (nystagmus) You may not be eligible for use of the iCare HOME2 tonometer if you: • have poor uncorrected near vision of 20/200 or worse •...

  • Page 10: Introduction

    WARNING! The tonometer is intended for personal use only and measuring other people, animals, or objects is forbidden. WARNING! If you need help in using the iCare HOME2 tonometer, contact your healthcare professional. WARNING! Federal law (U.S.) restricts this device to sale by or on the order of a physician or properly licensed practitioner.

  • Page 11: Information On Intraocular Pressure

    (supine position). The tonometer includes infrared eye recognition sensors to identify which eye, right or left, you are measuring. After the measurement, you can transfer the measurement data to iCare CLINIC or iCare CLOUD using your computer or mobile device.

  • Page 12: Sales Package Contents

    Sales package contents The iCare HOME2 sales package contains: • iCare HOME2 tonometer • Carrying case • Instruction Manuals • Probe applicator • Quick Guides • Screwdriver Torx TX8 • Spare probe base • Sterilized single-use probes • USB-C to Micro-USB B adapter •...

  • Page 13: Buttons And Parts

    Buttons and parts WARNING! Removing, covering, or defacing any label or sign on the tonometer voids all the responsibilities and liabilities of the manufacturer concerning the safety and effectiveness of the tonometer. Measure button Probe Navigation buttons 12. Probe base Select button 13.

  • Page 14: Get Started

    Get started 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 when in use. If the tonometer is dropped and the tonometer casing opens, press the casing to close the openings.

  • Page 15: Take A Measurement

    PRECAUTION! Before taking measurements, update the tonometer’s time to your local time manually from the tonometer’s settings or automatically by connecting the tonometer to the iCare PATIENT2 application or to the iCare EXPORT software. To ensure a reliable measurement result: •...
  • Page 16 Place the probe applicator over the probe base. Open the packaging. Remove the cap. Drop the probe from the container to the probe applicator. Remove the probe applicator.

  • Page 17: Switch On The Tonometer

    Make sure that the date and time shown on the display are correct. If they are incorrect, update them from the tonometer’s settings or by connecting the tonometer to the iCare PATIENT2 application or to the iCare EXPORT software. Press down until you hear a beep.

  • Page 18: Adjust The Supports And Position The Tonometer

    <90° If you see a red light in the probe base, the tonometer is tilted too much downwards. You should straighten your posture and lift your chin. Adjust the supports and position the tonometer WARNING! Only probes are intended for contacting the eye. Avoid touching the eye with other parts of the tonometer.
  • Page 19 Shorten the supports two clicks at a time to prevent the tonometer from getting too close to your eye. Place the tonometer 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.

  • Page 20: Measure Your Eye Pressure

    Keep both eyes open. Covering the eye not being tested may help you see the rings more clearly. Shorten the supports by rotating them clockwise two clicks at a time until you only see a symmetrical green ring. The tonometer is now at the correct distance from your eye.
  • Page 21 If the probe base flashes red and you hear multiple beeps, the measurement was not successful. The display and sounds indicate the source of the error. Look at the display and press to acknowledge the error. Make the necessary corrections and repeat the measurement. The errors and corrective actions are explained in chapter “8.7 Errors during the measurement”.

  • Page 22: Measure Your Eye Pressure In The Supine Position

    Measure your eye pressure in the supine position Before measuring, lie down (supine position) for a moment. Take a comfortable position on your back with a pillow behind your neck. Look straight ahead. Avoid bending your head and neck backwards. 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.

  • Page 23: Errors During The Measurement

    Errors during the measurement Screen Text Sound Description Actions Press the Measure TOO FAR 3 long The measurement button once to beeps was taken too acknowledge the error. far from the eye. Turn the supports The probe did not clockwise until the touch the eye.

  • Page 24: Check The Measurement Quality

    You can view your eye pressure readings using a mobile phone or a computer. For more information, see chapter “12 iCare software system”. The measurement quality is an indication of how much variation there was between the six individual measurement results.

  • Page 25: Switch Off The Tonometer And Dispose Of The Probe

    5–Green result means good measurement quality, yellow means acceptable quality. See chapter “12.3 Transfer measurement data to iCare CLINIC or iCare CLOUD” for advice on how to transfer your measurement results to the iCare CLINIC or the iCare CLOUD. Switch off the tonometer and dispose of...

  • Page 26: Rental Mode

    Once the rental time expires, the patient can no longer take measurements with the tonometer. For instructions on setting the rental mode, see the iCare CLINIC, EXPORT and PATIENT2 Instruction Manual for Healthcare Professionals. To see when the rental expires: Press and hold down to switch on the tonometer.

  • Page 27: Language Settings

    Press Press to move between the various settings. To select a setting, press To exit the settings, press SETTINGS BLUETOOTH PRACTICE LANGUAGE TIME DATE SOUND LIGHT BRIGHTNESS MODE ENGLISH 17:20 09/05/2019 11.1 Language settings To change the language, press until you see LANGUAGE. Press Press until you see the language you want, and press...

  • Page 28: Probe Base Light Settings

    CLINIC On-premises or iCare CLOUD Patients can store their measurement data to a private account in the iCare CLOUD service, if their tonometer is not registered to a healthcare professional’s iCare CLINIC account. For information on how to set up a private account, read the labelling material in the tonometer’s carrying case.

  • Page 29: Compliancy Standards

    Android) or App Store (for iOS) on the mobile device and search for iCare PATIENT2. Follow the installation instructions shown on the display. For information on how to set up a private account to the iCare CLOUD, read the Getting started guide in the tonometer’s carrying case.

  • Page 30: Transfer Measurement Data To Icare Clinic Or Icare Cloud

    Micro USB USB-C USB-A Open the iCare EXPORT software on your computer, or the iCare PATIENT2 application on your mobile device. Connect the tonometer to your mobile device or computer with the USB cable provided in the tonometer’s sales package. If your mobile device has a micro-USB port, use the adapter provided in the sales box.

  • Page 31: Bluetooth Notifications And Errors

    BLUETOOTH OFF Bluetooth is off. 000000 Bluetooth PIN code for Enter the PIN code on pairing the tonometer your mobile device or PIN CODE with iCare EXPORT or computer. iCare PATIENT2. BLUETOOTH Tonometer is Press CONNECTED connected to iCare acknowledge the EXPORT or iCare notification.

  • Page 32: Troubleshooting

    Write down the service ID shown on the display. Switch off the tonometer. Contact the organization from which you obtained the tonometer or Icare USA to arrange service for the tonometer. See chapter “14.4 Return the tonometer for service or repair”.

  • Page 33: Maintenance

    Maintenance WARNING! The tonometer should only be opened by qualified iCare service personnel. The tonometer does not contain any user-serviceable parts, apart from the batteries and the probe base. The tonometer does not require any routine servicing or calibration other than changing the batteries at least annually and the probe base every six months.

  • Page 34: Clean And Disinfect The Tonometer

    Turn the collar clockwise until it is firmly in place. Do not use excess force. Dispose of the used probe base. To order new probes or probe bases, contact the organization from which you obtained the tonometer or Icare USA. 14.2 Clean and disinfect the tonometer WARNING! Never immerse the tonometer in liquid.

  • Page 35: Lifetime

    Icare USA’s technical services department (go to https://www.icare-world.com/us/) for shipping instructions. Unless otherwise instructed by Icare USA, there is no need to ship any accessories with the tonometer. Use a suitable cardboard or similar box with the appropriate packaging material to protect the tonometer during shipment.

  • Page 36: Glossary

    (0.4” x 0.4” x 10.7”) Probe applicator 28 mm x 51 mm (0.01 lbs) (1.1” x 2.0”) Other supplies 7214 Probe base collar, iCare HOME2 19.5mm x 19.5mm (0.004 lbs) (0.8” x 0.8”) 577F USB manual, iCare HOME2 575B USB cable for PC connection-...

  • Page 37: Technical Information

    All the parts of the tonometer are applied parts and the tonometer has BF-type electric shock protection. 17.2 System requirements for iCare CLINIC • Internet connection • Minimum web browser versions: IE 11, Chrome (v 58), Firefox (v 53) and Safari (5.1.7)

  • Page 38: Network Specifications

    The iCare HOME2 tonometer collects measurement data. This data is sent via Bluetooth or USB connection to a computer (Bluetooth Low Energy, BLE) which has the iCare EXPORT software installed or to a mobile device with the iCare PATIENT2 application installed.

  • Page 39: Required Characteristics Of The It Network

    Safety: No adverse events (including corneal abrasions) were recorded in the study population. Results: The mean paired difference and standard deviation (iCare HOME2 - iCare IC200) were 0.55 mmHg and 2.69 mmHg. The iCare HOME2’s variability (difference of repeat measurements) for each patient was ~7.9% for all the IOP ranges.

  • Page 40: Symbols And Trademarks

    HOME2 tonometer demonstrated agreement with the true manometric pressures, R-squared values being at least 99.7%, regardless of the angle of measurement (0, 45 or 90 degrees). On average, the iCare HOME2 tonometer underestimated the pressure by 0.04 mmHg with respect to the true manometric pressures with standard deviation of 0.37 mmHg.

  • Page 41: Part Of The Tonometer

    Information for the user regarding the radio communication part of the tonometer The iCare HOME2 tonometer contains a Bluetooth transmitter working at frequencies between 2.402 GHz and 2.480 GHz. Due to the limited physical size of the tonometer, many of the relevant approval markings are found in...

  • Page 42: Bluetooth Module Information

    • This device must accept any interference received, including interference that may cause undesired operation Changes or modifications not expressly approved by Icare USA could void the user’s authority to operate the equipment. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules.

  • Page 43: Electromagnetic Declaration

    Guidance and Manufacturer’s Declaration IEC 60601-1-2:2014; Edition 4.0 Electromagnetic Emissions iCare HOME2 tonometer (TA023) is intended for use in a home healthcare environment with electromagnetic characteristics specified below. The user of the iCare HOME2 tonometer (TA023) should assure that it is used in such an environment.
  • Page 44 Guidance and Manufacturer’s Declaration IEC 60601-1-2:2014; Edition 4.0 Electromagnetic Immunity iCare HOME2 tonometer (TA023) is intended for use in a home healthcare environment with electromagnetic characteristics specified below. The user of the iCare HOME2 tonometer (TA023) should assure that it is used in such an environment.
  • Page 45 Guidance and Manufacturer’s Declaration IEC 60601-1-2:2014; Edition 4.0 Electromagnetic Immunity iCare HOME2 tonometer (TA023) is intended for use in a home healthcare environment with electromagnetic characteristics specified below. The user of the iCare HOME2 tonometer (TA023) should assure that it is used in such an environment.
  • Page 46 Guidance and Manufacturer’s Declaration IEC 60601-1-2:2014; Edition 4.0 Electromagnetic Immunity iCare HOME2 tonometer (TA023) is intended for use in a home healthcare environment with electromagnetic characteristics specified below. The user of the iCare HOME2 tonometer (TA023) should assure that it is used in such an environment.
  • Page 48 Icare Finland oy. Centervue S.p.A, Icare Finland Oy, and Icare USA Inc. are parts of Revenio Group and represent the brand iCare. Not all products, services or offers referenced in this brochure are approved or offered in every market and approved labeling and instructions may vary from one country to another.

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