Icare IC200 Instruction Manual
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Icare IC200 Instruction Manual

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iCare
IC200
ENGLISH
Instruction Manual
1

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Summary of Contents for Icare IC200

  • Page 1 IC200 ENGLISH Instruction Manual...
  • Page 2 Finland Oy, all other trademarks are the property of their respective owners. Made in Finland. 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

    Maintenance ............................24 Replacing the probe base ........................ 25 20 Cleaning the tonometer ........................25 Returning the iCare tonometer for service or repair ..............25 22 Periodic safety checks ........................25 23 Symbols ...............................26 24 Information to the user regarding the radio communication part of the device ....27...

  • Page 4: Safety Information

    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 changing the probe base.
  • Page 5 WARNING! The responsible organization should identify, analyze, evaluate, and control any additional risks resulting from the IC200 tonometer connected to IT networks including other equipment. WARNING! The tonometer must not be repaired or re-assembled by any other than the manufacturer or its authorized service center.
  • Page 6 PRECAUTION! Use only the types of battery specified in the Technical Information section of this instruction manual. PRECAUTION! 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 7: Intended Use

    (IOP) to be measured by a healthcare professional accurately, rapidly and without an anesthetic. 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.

  • Page 8: Package Content

    7. Select button 8. Measure button 7 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).

  • Page 9: Installing The Batteries For The First Time

    The tonometer can be activated in one of two ways. Either press the Select or the Measure button once. The following figure sequences illustrate the two alternative ways of starting the tonometer: 16/03/2017 16:36:10 IC200 MEASURE After pressing the Select button...

  • Page 10: Patient Id

    (see figure). The tonometer will magnetize the probe and hold it in the probe base. A probe can be loaded into the iCare IC200 tonometer even if the device has not yet been turned on. In this case, the...

  • Page 11: Measurement

    the tonometer device and probe by emitting a red light – if the device is tilted too far up – or a green light when the orientation of the device is acceptable. Secondly, the indicator light color changing to red can communicate an error situation during the measurement sequence, in addition to messages shown on the device’s display screen (see Chapter 13 Error and info messages).
  • Page 12 The tonometer is now ready to measure, indicated by the Play symbol displayed on the screen. If you have selected and confirmed the eye side or the patient ID, this information is also displayed on the screen. ID 9 Ready to measure display with the eye’s side Patient ID selected selection options: OD, no information, OS.
  • Page 13 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 14: Quick Measure

    Measure (to the right of the default Measure) and select it by either pressing on the Select button or the Measure button. Once you have selected the Quick Measure, load an iCare probe as instructed in Chapter 8 Loading the probe, and perform the measurement as you would when using the default Measure function.

  • Page 15: User Interface Functions

    Quick Measure are also identified with the Quick Measure symbol. 11 User interface functions 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 device. Pressing either of the two Navigation buttons (left/right arrows) allows for changing a selection in a displayed menu, the center Select button is for activating a selection.
  • Page 16 SOUND – Adjusting the beep volume The tonometer offers three sound levels, in addition to a silent mode. The sound level is indicated with a 3-level bar. SOUND SOUND SOUND LIGHT – Adjusting the Probe base light brightness The intensity of the Probe base light can be adjusted to one of three levels, or switched to LIGHT LIGHT...

  • Page 17: Bluetooth

    12.1 Printer 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. The connection (pairing) is automatically stored, and if disconnected, resuming is fast and simple by activating the connection.
  • Page 18 MODE ME21 REMOVED • Press the Select button to remove the pairing between the IC200 device and the printer. To print the results to the paired printer ID 9 right after the completed measurement: • Navigate with the Navigation buttons to PRINT.

  • Page 19: Export

    BLUETOOTH EXPORT and the mac id in turn on the screen. • If the pass key is incorrect, IC200 will display PAIRING ERROR. The error needs to be acknowledged by pressing the Select button. To activate the pairing with the...

  • Page 20: Error And Info Messages

    • Select the IC200 device in the iCare EXPORT software. • At this point measurements are sent to cloud for further management with software. • You will also be able to set software to send measurements to cloud from the IC200 device as you take measurements.
  • Page 21 In 2 seconds the IC200 returns to the screen computer is lost. previously used. Try to reconnect. CONNECTION LOST The Select button was In 2 seconds the IC200 returns back to the PAIR pressed to exit the pairing NEW screen. on the EXPORT MODE. PAIRING CANCELLED...

  • Page 22: Measurement Flow Chart

    14 Measurement flow chart Turn the tonometer ON by pressing the Select or Measure button IC200 This is displayed if you pressed the Select button, pressing of the Measure button would lead you directly to Load Probe MEASURE Load probe...

  • Page 23: Technical Information

    16 x 90 mm 567* Silicone grip, dark gray 26 g 45 x 35 x 113 mm 577E USB memory stick, iCare IC200 44 g 98 x 11 x 93 mm 544B Probe base cover, iCare IC200 19 x 11 mm...

  • Page 24: Network Specifications

    IT Network over Bluetooth. The IC200 tonometer is designed to work stand-alone without the Bluetooth connection. The IC200 tonometer is designed such that network failures will not prevent the IC200 tonometer from working normally.

  • Page 25: Performance Data

    (iCare-GAT) in sitting position were 0.52 mmHg and 1.72 mmHg. A scatterplot and Bland-Altman plot of the results is shown in Figure 1 and Figure 2.” (Figure 1 = deming regression IC200 vs. GAT, Figure 2 = Bland-Altman plot IC200 vs. GAT).

  • Page 26: Quick Measure

    17.2 Quick Measure Quick Measure performance data was obtained from a retrospective clinical data analysis in which Quick Measure function was retrospectively compared to the clinical data of iCare IC200. In the analysis Quick Measure met ANSI Z80.10:2014 performance goals per GAT reference tonometer.

  • Page 27: Maintenance

    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.

  • Page 28: Replacing The Probe Base

    • Screw the collar down until it firmly locks the probe base. 20 Cleaning the tonometer 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 29: Symbols

    Applicable in Germany only: Messtechnische Kontrolle nach MPG (Medizinproduktegesetz) alle 12 Monate. 23 Symbols General warning sign Lot number Consult operating instructions Manufacturing date Serial number Sterilized using irradiation Single use only Keep dry Use by Non-ionizing radiation Protected against access to hazardous parts with a finger.

  • Page 30: Information To The User Regarding The Radio Communication Part Of The Device

    2. This device must accept any interference received, including interference that may cause undesired operation Changes or modifications not expressly approved by Icare Finland Oy 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 31: Electromagnetic Declaration

    CISPR 32 and CISPR 35. The 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 32 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. RF emissions CISPR 11 Group 1 iCare IC200 (TA031) is battery operated and uses RF energy only for its internal function.
  • Page 33 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 IEC 60601 test level...
  • Page 34 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 IEC 60601 test level...
  • Page 36 Icare Finland Oy. Icare Finland Oy, Icare USA, Inc., iCare World Australia Pty Ltd and Centervue S.p.A., are parts of Revenio Group and represent the brand iCare. Not all products, accessories, services or offers are approved or offered in every market and approved labelling and instructions may vary from one country to another.

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