ENGLISH
USER’S AN D M AI N TEN AN CE M AN UAL
Icare tonometer ONE manual
Icare® ONE (Model: TA02) INSTRUCTION MANUAL v1.12
 English
01/14 EN
0044
This device complies with:
Medical Device Directive 93/42/EEC
Canadian Medical Device Regulations
Copyright © 2012 Icare Finland Oy
Made in Finland
Icare Finland Oy
Äyritie 22, FI-01510 Vantaa, Finland
Tel. +358 9 8775 1150, Fax +358 9 728 6670
www.icarefinland.com, info@icarefinland.com
TABLE OF CONTESTS
Table of contests ................................................................................................................................................................................................................2
Safety instructions .............................................................................................................................................................................................................2
Indications for use .............................................................................................................................................................................................................3
Usage contraindications ....................................................................................................................................................................................................4
Introduction .......................................................................................................................................................................................................................4
Package contents ...............................................................................................................................................................................................................4
Turning the device on ........................................................................................................................................................................................................5
Setting up the tonometer before taking measurements ...................................................................................................................................................6
Choosing a measurement mode ........................................................................................................................................................................................6
Adjusting the measurement position.................................................................................................................................................................................6
Loading the probe ..............................................................................................................................................................................................................7
Measuring intraocular pressure .........................................................................................................................................................................................8
Patient Use Instructions .....................................................................................................................................................................................................9
Error messages and indicators .........................................................................................................................................................................................10
Differences between professional user and the patient using the Icare ONE Tonometer ...............................................................................................10
Cleaning and disinfection .................................................................................................................................................................................................11
Changing the batteries .....................................................................................................................................................................................................11
Service procedures ..........................................................................................................................................................................................................12
Spare parts .......................................................................................................................................................................................................................12
Technical and performance data .....................................................................................................................................................................................12
Clinical performance data ................................................................................................................................................................................................13
Symbols ...........................................................................................................................................................................................................................14
SAFETY INSTRUCTIONS
WARNING!
The tonometer must not come into contact with the patient’s eyes, except for the probes, which may do so for a fraction of a second during
measurement. Do not bring the tonometer into contact with the eye or push it into the eye (the tip of the probe should be 4-8mm, or 5/32-5/16
inch, from the eye).
WARNING!
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.
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WARNING!
Health care professionals must inform patients not to modify or discontinue their treatment plan without receiving instructions from the health care
professional.
WARNING!
Do not change your medication or dosage without consulting your doctor.
WARNING!
IOP accuracy and repeatability are unknown for patients with corneal astigmatism > 3.00 D of astigmatism, irregular astigmatism and keratoconus.
WARNING!
Patients with hearing loss may not detect signals that indicating correct measurements.
WARNING!
Patients with physical challenges may experience difficulty in using the hand-held tonometer.
WARNING!
No modification of this equipment is allowed
CAUTION!
Before using the tonometer read this manual carefully. Keep it for future use. It contains important information on using and servicing the
tonometer.
CAUTION!
Federal (US) law restricts this device to sale by or on the order of a physician or properly licensed practitioner.
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When you have opened the package, check for any external damage or faults, particularly for damage to the case. If you suspect
that there is something wrong with the tonometer, contact the dealer.
Use the tonometer only for measuring intraocular pressure. Any other use is improper and the manufacturer cannot be held liable
for any damage arising from improper use, or for the consequences thereof.
Never open the casing of the tonometer, except for the battery compartment or to change the probe base.
Never use the tonometer in wet or damp conditions nor allow the tonometer to get wet.
The probe base, battery compartment cover, screws, collar and probes are so small that a child could swallow them. Keep the
tonometer out of the reach of children.
Do not use the device near inflammable substances, including flammable anesthetic agents.
Certain microbiological agents (for example, bacteria) can be transmitted from the forehead, eye or cheek support. To avoid this,
the forehead and cheek support and eye piece must be cleaned for each new patient with disinfectant, for example an alcohol
solution.
The tonometer conforms to EMC requirements (IEC 60601-1-2), but interference may occur in it if used near (<1m) a device (such as
a cellular phone) causing high-intensity electromagnetic emissions. Although the tonometer’s own electromagnetic emissions are
well below the levels permitted by the relevant standards, they may cause interference in other, nearby devices, for example,
sensitive sensors.
If the device is not to be used for a long time, remove its batteries, as they may leak. Removing the batteries restores the device to
normal measurement mode.
For every patient to be measured take a new probe to avoid cross contamination of bacteria or viruses and infection of the eye
Use probes taken only from original intact packaging. Sterility of the probe cannot be guaranteed once the seal is compromised.
The tonometer probes are labeled single-use only. Re-sterilization or re-use of the probe can result in incorrect measurement or
damage to the probe head.
Be sure to dispose of the single-use probes properly (for example, in a container for disposable needles). Probes may become
contaminated with micro-organisms after one-time use.
Do not connect the USB cable during measurements. When connected it is impossible to perform measurement.
Do not change the batteries or probe base when the USB-cable is connected.
Batteries, packaging materials and probe bases must be disposed of according to local regulations. Use only original probes (see
Figure 5) and accessories.
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.
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USAGE CONTRAINDICATIONS
The TA02 tonometer is contraindicated in the presence of the following conditions:
Corneal Scarring, Microphtalmos, Buphthalmos, Nystagmus, Keratoconus, abnormal central corneal thickness, and topical anesthetics.
INTRODUCTION
Icare ONE tonometer is intended to monitor intra-ocular Pressure (IOP) of the human eye. It is indicated to be used by health care professionals and
by patient under prescription use only.
It is based on a patented, induction-based rebound method, which allows intraocular pressure (IOP) to be measured accurately, rapidly and without
an anesthetic.
Icare One uses sterilized disposable probes in order to reduce the risk of microbiological contamination to a negligible level.
Intraocular pressure changes are due to the effects of pulse, breathing, eye movements, and body position. Several measurements are taken using
the handheld device within fractions of a second to average the micro changes of IOP that occur during measurement. In the automated mode, six
pre-programmed measurements are needed to obtain an accurate reading.
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.
PACKAGE CONTENTS
The package contains:
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Icare ONE tonometer
10 sterilized single-use probes
2 eye supports (small and large)
2 Batteries
USB cable
User manual
Instructions for downloading Icare LINK software
Warranty card
Carry-on case
Mode switch key
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3.
1.
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6
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7.
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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. POSITION ERROR LED
6. REPEAT ERROR LED
7. CLEAN ERROR LED
TURNING THE DEVICE ON
6. REPEAT LED
Press the measurement button to turn the tonometer on. All LEDs are displayed briefly.
7. CLEAN LED
One of the lower IOP indicator LEDs remains lit for 2 seconds while other LEDs switch off. The LED indicates the battery voltage.
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GREEN = OK
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YELLOW = REDUCED
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RED = LOW, change battery
IOP indicator LEDs
One indicator LED remains lit for 2 seconds to show battery voltage
PROBE LED
POSITION LED
REPEAT LED
CLEAN LED
Tonometer LED panel
Following a brief pause, the PROBE LED blinks to remind the user to load the single use probe into the tonometer prior to measurement.
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Accuracy of display: display is divided into 11 ranges:
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5-7 mmHg
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7-10 mmHg
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10-14 mmHg
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14-18 mmHg
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18-21 mmHg
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21-24 mmHg
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24-27 mmHg
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27-30 mmHg
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30-35 mmHg
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35-40 mmHg
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40-50 mmHg
SETTING UP THE TONOMETER BEFORE TAKING MEASUREMENTS
Before taking measurements your tonometer, the measurement position must be adjusted correctly by health care professional. Set-up includes:
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Choosing a measurement mode
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Adjustment of the measurement position
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Loading the probe before each measurement
CHOOSING A MEASUREMENT MODE
The device can operate in two modes:
Normal
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Normal mode is used to take individual measurements one at a time. The measurement button must be pressed once to initiate each of
the six measurements to obtain final IOP reading. Normal mode is generally used when measurements are taken by someone other than
the patient.
Automatic
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Automatic mode is especially useful in self tonometry. In automatic mode a single press of the measurement button initiates the
measurement function and the tonometer takes six measurements automatically to obtain final IOP reading.
NOTE!
Device is designed to perform six subsequent movements of probe to cornea /measurements after which the device calculates the final IOP range.
The final IOP range is displayed on device LED panel.
To change the measurement mode:
1. Turn on the tonometer.
2. Insert a straight pin into the mode switch hole on the side of the tonometer.
Mode switch hole
Measurement mode switch
3.
Push the switch with mode switch key provided with the tonometer on the bottom of the mode switch hole of the tonometer until the
mode change signal is heard. The switch must be pressed for approximately three seconds for the mode to change.
The audible sound indicates the measurement mode:
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one beep: normal mode
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three beeps: automatic mode
ADJUSTING THE MEASUREMENT POSITION
The tonometer has two adjustable supports, one for the forehead and one for the cheek as shown in figure. These supports are adjusted to ensure
accurate measurement distance and alignment. Adjust the supports using the adjustment wheels, so the distance from the tip of the probe to the
surface of the cornea is 4-8 mm (5/32-5/16 inch) and the probe is horizontal.
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Forehead support
Adjustment wheels
Cheek support
Tonometer forehead and cheek supports with adjustment wheels
An optional eye support can be used for easy alignment and additional stability during measurement. When the eye support is used, the cheek
support is not used and needs to be adjusted to minimum setting. The eye support can be used for both eyes by rotating it from one side.
Eye support
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.
Disposable tonometer probe and probe container
To load the probe:
1. Open the lid of the probe container as shown in figure.
CAUTION!
To prevent contamination do not touch the probe tip with fingers.
Open the probe container
2.
Insert the probe into the probe base by turning the probe container upside down as shown in figure.
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Inserting probe into probe base
3.
After the probe has been inserted, be careful not to point the tonometer downward to prevent the probe from falling out.
4.
Press the measurement button once to activate the inserted probe. During activation the device magnetizes the probe (probe
moves rapidly back and forth).
Once the probe is activated, the PROBE LED remains lit. The tonometer is now ready to take a measurement.
MEASURING INTRAOCULAR PRESSURE
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A measurement sequence is a set of six measurements. The measurement value, shown after all six measurements are taken, is
displayed on LED display. The measurement value is an average of four successful interim measurements of those six interim
measurements performed. The highest and the lowest value is left out from final value displayed. If there is too much variation in
average (SD) error code REPEAT is lit on LED display. See error messages and indicators.
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In the automatic mode the six measurements in a sequence are taken automatically and in the normal mode the user must take
each measurement individually until all six measurements are taken.
To measure intraocular pressure:
1.
2.
Check that the tonometer is set up correctly and the measurement position is adjusted by a doctor or a nurse.
The patient should relax, and look straight ahead at a specific point while keeping eyes wide open.
Patient with the tonometer correctly positioned
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3.
Bring the tonometer near the eye in front of a wall mirror as shown in Figure (Measurement step). Move the tonometer closer so
that the forehead and cheek support touch the skin. The distance from the tip of the probe to the center of the cornea must be
4-8 mm (5/32-5/16 inch).
4.
Press the measurement button lightly to perform the measurement, taking care not to shake the tonometer. The tip of the probe
should make contact with the central cornea. The way you take measurements depends on the chosen mode.
In Automatic mode, press the measurement button once to perform the measurement. A long beep indicates the end of one
measurement sequence (six measurements). In automatic mode single measurement values are not shown.
In Normal mode, press the measurement button to take one individual measurement at a time. A short beep sounds after each
measurement. A long beep sounds when the six measurement sequence is complete.
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). Press the measurement button again to clear the error message and
follow the corrective actions according to indicators described on page 10.
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In normal mode a value is shown briefly after each successful measurement. When the six measurements in sequence are completed and the
measurement result is valid, the final value range is displayed. If there is too much variation between the measurements, the REPEAT ERROR LED is
displayed and the measurement needs to be performed again. The device stores the quality of the measurement in its internal memory, which is
only accessible by downloading to a PC using the Icare® LINK software.
A new measurement needs to be taken if:
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REPEAT ERROR LED is displayed, for example, if the probe made contact with the eyelid.
Encountering unusual values, for example, over 22 mmHg or below 8 mmHg.
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.
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.
MEASUREMENT STEP
Measurement position
PATIENT USE INSTRUCTIONS
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When taking measurements:
NOTE
Before performing self tonometry the patient must have the tonometer set up by a health care professional. The doctor or nurse has adjusted the
distance between the tip of the probe and the center of the cornea with the forehead and cheek support to be 4-8 mm, (5/32-5/16 inch).
NOTE
The tonometer must be held in a vertical position. Angle of inclination has limited to ± 22° to ensure reliable outcome.
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Doctor or nurse has adjusted the measurement position.
Doctor or nurse has demonstrated to the patient how to use the tonometer
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Switch on the unit, load the probe
Go in front of a wall mirror
Take the tonometer in your hand with the white main button pointing upwards
Move the tonometer sideways toward your eye so that you see in the mirror the white tip of the probe in front of the black pupil
Move the tonometer closer so that the forehead and cheek supports touch the skin
Check that the white tip of the probe is seen in front of the center of the cornea (pupil)
Turn the tonometer from the sideway position so that the tonometer with the loaded probe points straight to the center of the cornea
(pupil)
Open your eyes wide and try not to blink your eye while measuring
Press the measurement button once. You will get the final result after the probe touched you eye for six times and after one long beep.
In automatic mode the six interim measurements are taken in sequence.
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CAUTION!
Always perform measurement on RIGHT eye first followed by LEFT eye. Complete the RIGHT eye measurement sequence before changing to the
LEFT eye.
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A new measurement needs to be taken if:
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REPEAT ERROR LED is displayed, for example, if the probe made contact with the eyelid.
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Encountering unusual values, for example, over 22 mmHg or below 8 mmHg.
ERROR MESSAGES AND INDICATORS
Icare Tonometer ONE display panel shows the following LEDs:
LED
State
Description and Action
PROBE
BLUE blinking
Load probe
BLUE lit
Ready to use
POSITION
RED lit
Check distance and alignment
REPEAT
RED lit
Standard deviation too high – repeat the whole measurement sequence
CLEAN
RED lit
Clean or change the probe base
DIFFERENCES BETWEEN PROFESSIONAL USER AND THE PATIENT USING THE ICARE ONE
TONOMETER
Instructions for the health care professional
1.
2.
3.
4.
5.
6.
Check that the tonometer is set up correctly by a
doctor or a nurse.
The patient should relax, and look straight ahead at a
specific point while keeping eyes wide open.
Bring the tonometer near the eye. Move the
tonometer closer so that the forehead and cheek
support touch the skin. Check that the white tip of the
probe is seen in front of the center of the cornea
(pupil). The distance from the tip of the probe to the
center of the cornea must be 4-8 mm (5/32-5/16 inch).
Press the measurement button lightly to perform the
measurement, taking care not to shake the tonometer.
The tip of the probe should make contact with the
central cornea (pupil). The way you take
measurements depends on the chosen mode.
In normal mode a value is shown briefly after each
successful measurement. When the six measurements
in sequence are completed and the measurement
valid, the final value of IOP is displayed. If there is too
much variation between the measurements, the
REPEAT ERROR LED is displayed and the measurement
needs to be performed again. The device stores the
quality of the measurement in its internal memory,
which is only accessible by downloading to a PC using
the Icare LINK software.
A new measurement needs to be taken if:
REPEAT ERROR LED is displayed, for example, if the
probe made contact with the eyelid.
Encountering unusual values, for example, over
22 mmHg or below 8 mmHg.
Instruction for the patient
1.
2.
3.
4.
5.
6.
7.
8.
9.
Switch on the unit, load the probe
Go in front of a wall mirror
Take the tonometer in your hand with the white
main button pointing upwards
Move the tonometer sideways toward your eye so
that you see in the mirror the white tip of the probe
in front of the black pupil
Move the tonometer closer so that the forehead
and cheek supports touch the skin
Check that the white tip of the probe is seen in
front of the center of the cornea
Turn the tonometer from the sideway position so
that the tonometer with the loaded probe points
straight to the center of the cornea (pupil)
Open your eyes wide and try not to blink your eye
while measuring
Press the measurement button once. You will get
the final result after the probe touched you eye for
six times and after one long beep. In automatic
mode the six interim measurements are taken in
sequence.
A new measurement needs to be taken if:
REPEAT ERROR LED is displayed, for example, if the
probe made contact with the eyelid.
7.
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. If a patient does not have the
software, the tonometer is taken to a health care
professional who can transfer the data.
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).
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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.
If the tonometer displays a CLEAN error (CLEAN LED), the probe base (see Figure below) may be dirty or dusty. To clean the probe base first unscrew
the probe base off the tonometer. Carefully inject isopropyl alcohol (rubbing alcohol) through the top of the probe base. Dry the probe base by
injecting air into the probe base and drying the part gently. If it is not possible to clean the probe base, then replace it with a new one.
Probe base
Tonometer probe base
Probe base
Tonometer probe base unscrewed
CHANGING THE BATTERIES
Lift the silicone lid that protects the USB-port and keeps the battery compartment cover in place. Open the battery compartment cover by pressing
the silicone lid slightly and sliding the battery compartment cover as shown in figure.
Battery compartment
cover
Silicone lid
Opening the silicone lid and battery cover
Insert two CR123A lithium batteries in the correct order: (+) end upwards as shown in figure. Close the cover firmly and press the silicone lid in place
to cover the USB port.
NOTE
Make sure you use batteries with built-in PTC protection, For Example Energizer Lithium Photo 123 3V CR123A.
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Inserting new batteries
SERVICE PROCEDURES
Replace the batteries when the device indicates low battery voltage.
Clean or change the probe base if the probe does not move smoothly (CLEAN LED is lit).
NOTE
No other service procedures can be carried out by the user. All other service and repair must be carried out by the manufacturer or a certified
service center.
SPARE PARTS
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Single-use probes (10 included with the tonometer when purchased)
Probe base kit
Eye supports
Mode switch key
USB cable
Batteries
carry on case
These can be purchased from a local distributor of Icare products.
TECHNICAL AND PERFORMANCE DATA
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Type TA02
The device conforms to CE regulations
Dimensions: approximately 11 cm x 8 cm x 3 cm
Weight: approximately 150 g
Power supply: 2•CR123 batteries (make sure you use batteries with built-in PTC protection, For Example Energizer Lithium Photo
123 3V CR123A)
Measurement range: 5-50 mmHg
Display range: 5-50 mmHg
Accuracy (95% tolerance interval relatively to manometry): ± 1.8 mmHg
Repeatability (coefficient of variation):
< 9% @ IOP ≤20 mmHg
< 3% @ IOP >20 mmHg
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
30-35 mmHg
35-40 mmHg
40-50 mmHg
Display unit: mmHg
The serial number is located on the inside of the battery compartment cover
There are no electrical connections from the tonometer to the patient
The device has BF-type electric shock protection
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Operation environment
Temperature: +10 °C to +35 °C
Relative humidity: 30 % to 90 %
Atmospheric pressure: 800 hPa – 1060 hPa
Storage environment
Temperature: -10 °C to +55 °C
Relative humidity: 10 % to 95 %
Atmospheric pressure: 700 hPa – 1060 hPa
Transport environment
Temperature: -40 °C to +70 °C
Relative humidity: 10 % to 95 %
Atmospheric pressure: 500 hPa – 1060 hPa
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
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SYMBOLS
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Caution
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See operating instructions
for more information
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Manufacturing date
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BF-type device
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Lot number
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Single-use disposable
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Sterilized using irradiation
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Serial number
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Stand by
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Do not discard this product with other household-type waste.
Send to appropriate facility for recovery and recycling.
EU WEEE (European Union Directive for Waste of Electronic
and Electrical Equipment)
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Use by <date>
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Keep dry
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