Icare ic200 Instruction Manual

Icare ic200 Instruction Manual

Tonometer
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INSTRUCTION MANUAL
ENGLISH

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  • Page 1 INSTRUCTION MANUAL ENGLISH...
  • Page 2: Table Of Contents

    RoHS Directive 2011/65/EU Radio equipment directive 2014/53/EU. Copyright © 2018 Icare Finland Oy. All rights reserved. Icare is a registered trademark of Icare Finland Oy, all other trademarks are the property of their respective owners. Made in Finland. Icare Finland Oy/Tiolat Oy Äyritie 22, FI-01510 Vantaa, Finland...
  • Page 3: Safety Instructions

    Changes or modifications not expressly approved by Icare Finland Oy could void the user’s authority to operate the equipment. WARNING Never immerse the Icare tonometer in liquid. Do not spray, pour or spill liquid onto the Icare tonometer, its accessories, connectors, switches or openings in the chassis. Remove any liquid appearing on the surface of the tonometer immediately.
  • Page 4 Use only the types of battery specified in the Technical Information section of this instruction manual. The measurement method of the Icare ic200 tonometer is based on magnetic induction and therefore an external magnetic field in line with the probe may prevent the measurement.
  • Page 5: Intended Use

    The Icare ic200 tonometer allows for a patient’s IOP to be measured for patients in the supine position as well as in upright (sitting or standing) positions. With the Icare rebound measurement method, a miniature, light-weight probe is launched in a direction perpendicular to the surface of the center of the cornea of the eye.
  • Page 6: Taking The Device Into Use

    ENGLISH TAKING THE DEVICE INTO USE Before using the Icare ic200 tonometer for the first time, attach the wrist strap and insert the batteries. INSTALLING THE WRIST STRAP Thread the string loop at the end of the wrist strap through the two holes at the bottom of the device (see figure below). Take hold of the end of the wrist strap, turn it back and bring it through the loop.
  • Page 7: Turning The Tonometer On

    1.10 ID 9 ID 9 ID 9 A probe can be loaded into the Icare ic200 tonometer even if the device has not yet been turned ID 9 ID 9 ID 9 on. In this case, the tonometer recognizes that a probe has been inserted when entering the...
  • Page 8: Measurement

    Icare ic200 tonometer manual ENGLISH MEASUREMENT PRECAUTION If the tonometer is not used for 3 minutes, it will automatically switch itself off. PRECAUTION Do not use any anesthetic to numb the eye, an anesthetic can affect the measurement results (Badouin C, Gastaud P. Influence of topical anesthesia on tonometeric values of intraocular pressure.
  • Page 9 18/09/2017 07:37:45 AM ID 9 Icare ic200 tonometer manual ENGLISH 2/100 STEP 3. Ensure that the forehead support is fully extended by turning the forehead support adjustment wheel. In order to perform a successful measurement, the distance from the tip of the probe to the patient’s cornea (see picture) should be about 5 mm (about 3/16 inch). Bring the tonometer in front of the patient’s 18/09/2017 eye with the probe pointing to the center of the cornea until the forehead support touches the forehead.
  • Page 10 In addition, if you observe an unusually high or low displayed value of IOP, it is recommended that you make another measurement, either with the Icare tonometer or using an alternative method in order to verify the unusual reading.
  • Page 11: User Interface Functions

    ID 9 HISTORY PATIENT ID BLUETOOTH BLUET The Icare ic200 tonometer device uses a large, color display screen as part of its user interface. Three buttons below the screen allow the user to control the MEASURE HISTORY PATIE PATIENT ID...
  • Page 12: Bluetooth

    ID 9 ME21 ID 9 ID 9 To print you first need to pair the ic200 with a Bluetooth (Classic) printer. Pairing means that you create a connection between the ic200 device and the printer. 2/100 TO MENU 12.8 12.3 12.6...
  • Page 13: Export

    12.5 PATIENT ID To export the measurement results you first need to pair the ic200 with the computer having a Bluetooth (Low Energy) functionality and the Icare EXPORT If connection to PC/ Mobile device already exists If connection to PC/ Mobile device already exist...
  • Page 14: Error And Info Messages

    PAIRING 740A CANCELLED CHANGE 14.0 CHANGE CHANGE 13.9 The connection to the computer is lost. In 2 seconds the ic200 returns to the screen previously used. Try to reconnect. UNPAIR 14.1 14.3 14.2 TOO NEAR REPEAT TOO FAR 740A 14.5 14.6...
  • Page 15: Measurement Flow Chart

    18/09/2017 07:37:45 AM ID 9 ID 9 2/100 ID 9 ID 9 Document name: GUI Flowchart TA031 BACK BACK Icare ic200 tonometer manual ENGLISH 2/100 2/100 Document number: TA031-GUI 2/100 18/09/2017 Revision: 04 07:37:45 AM mmHg Date: 11.14.2017 mmHg 17.4 17.2 17.8...
  • Page 16: Accessories

    Intended Information Flow: Measurement data is collected by the ic200 Tonometer. This data is sent via Bluetooth connection either to a wireless printer (Bluetooth Classic), or to the computer (Bluetooth Low Energy, BLE) which has the Icare Export application installed. The Icare Export will transfer the data into the Icare CLINIC software.
  • Page 17: Performance Data

    WARNING The tonometer should only be opened by qualified service personnel. It contains no user-serviceable parts, apart from the batteries and a probe base. The Icare tonometer requires no routine servicing or calibration other than changing the batteries at least every 12 months and the probe base. If there is reason to believe servicing of the device is necessary, contact qualified service personnel or your local Icare representative.
  • Page 18: Returning The Icare Tonometer For Servicing Or Repair

    Contact Icare Finland’s Technical Services Department (see www.icaretonometer.com) or your local Icare representative for shipping instructions. Unless otherwise instructed by Icare Finland, 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 device during shipment.
  • Page 19: Information To The User Regarding The Radio Communication Part Of The Device

    Changes or modifications not expressly approved by Icare Finland Oy could void the user’s authority to operate the equipment. Icare ic200 (TA031) device contains a Bluetooth transmitter working at frequencies between 2.402 GHz and 2.480 GHz. Due to the limited size available on the device, many of the relevant approval markings are found in this document.
  • Page 20: Electromagnetic Declaration

    Icare ic200 (TA031) tonometer is a class B equipment and needs special precautions regarding EMC and needs to be installed and put into service according to EMC information provided in following tables.
  • Page 21 GUIDANCE AND MANUFACTURER’S DECLARATION IEC 60601-1-2:2014; EDITION 4.0 - ELECTROMAGNETIC IMMUNITY Icare ic200 (TA031) is intended for use in a professional healthcare environment with electromagnetic characteristics specified below. The user of the Icare ic200 Tonometer (TA031) should assure that it is used in such an environment. Immunity test...
  • Page 22 GUIDANCE AND MANUFACTURER’S DECLARATION IEC 60601-1-2:2014; EDITION 4.0 - ELECTROMAGNETIC IMMUNITY Icare ic200 (TA031) is intended for use in a professional healthcare environment with electromagnetic characteristics specified below. The user of the Icare ic200 Tonometer (TA031) should assure that it is used in such an environment. Immunity test...
  • Page 23 Icare ic200 tonometer manual ENGLISH NOTES www.icaretonometer.com...

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