I-care TA01i User manual

www.icaretonometer.com 1
USER’S AN D M AIN TEN AN CE M AN UAL
ENGLISH
INSTRUCTION MANUAL

Icare tonometer TA01i manual English
www.icaretonometer.com
2
TONOMETER
Icare® TA01i
INSTRUCTION MANUAL TA01i-001 EN-3.1
The information in this document is subject to change without prior notice.
In a conflict situation the English version prevails.
0044
This device complies with:
Medical Device Directive 93/42/EEC
Canadian Medical Device Regulations
Copyright © 2015 Icare Finland Oy
Made in Finland
Icare Finland Oy/Tiolat Oy
Äyritie 22, FI-01510 Vantaa, Finland
Tel. [phone], Fax [phone]
www.icarefinland.com, [e-mail]
TABLE OF CONTENTS
Indications for use...................................................................................................................................................................................................................... 3
Introduction ............................................................................................................................................................................................................................... 3
Safety instructions...................................................................................................................................................................................................................... 3
Parts of the tonometer............................................................................................................................................................................................................... 4
Turning the tonometer on and loading the probe...................................................................................................................................................................... 4
Load the probe in the following way: ................................................................................................................................................................................... 4
Measurement............................................................................................................................................................................................................................. 4
Display after measurements ...................................................................................................................................................................................................... 5
Other functions .......................................................................................................................................................................................................................... 5
Accessing old measurement value........................................................................................................................................................................................ 5
Turning the tonometer OFF .................................................................................................................................................................................................. 5
Error messages ..................................................................................................................................................................................................................... 5
Diagram of tonometer functions................................................................................................................................................................................................ 6
Technical information ................................................................................................................................................................................................................ 6
Performance data....................................................................................................................................................................................................................... 7
Accessories................................................................................................................................................................................................................................. 7
Maintenance .............................................................................................................................................................................................................................. 7
Replacing the probe base...................................................................................................................................................................................................... 8
Cleaning the probe base ....................................................................................................................................................................................................... 8
Cleaning the tonometer........................................................................................................................................................................................................ 8
Replacing the batteries ......................................................................................................................................................................................................... 8
Returning the Icare tonometer for servicing /repair............................................................................................................................................................. 9
Periodic Safety Checks .......................................................................................................................................................................................................... 9
Patents and copyrights............................................................................................................................................................................................................... 9
Symbols...................................................................................................................................................................................................................................... 9
Electromagnetic declaration ...................................................................................................................................................................................................... 9

Icare tonometer TA01i manual English
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3
INDICATIONS FOR USE
The Icare tonometer TA01i is intended to be used for the measurement of intraocular pressure of the human eye.
INTRODUCTION
The Icare tonometer is used in the diagnosis, follow up and screening of glaucoma. It is based on a new, patented, induction-based rebound method,
which allows intraocular pressure (IOP) to be measured accurately, rapidly and without an anesthetic.
Since single-use probes are used for measurement, there is no risk of microbiological contamination. No part of the tonometer or probes are made with
natural rubber latex. Intraocular pressure changes due to the effects of the pulse, breathing, eye movements and body position. Because measurements
are taken using a handheld device in fractions of a second, several measurements are needed to obtain an accurate reading and there fore the software is
pre-programmed for six measurements.
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 1/6 –1/3 inch, from
the eye).
WARNING
The tonometer should only be opened by qualified service personnel. It contains no userserviceable parts, apart from the batteries and a probe base. The
Icare tonometerrequires no routine servicing or calibration other than changing the batteries at least every 12 months or changing or cleaning the probe
base. If servicing is necessary, contact qualified service personnel or your local Icare representative.
WARNING
Never spray, pour or spill liquid onto the Icare tonometer, its accessories, connectors, switches or openings in the chassis. Dry any liquid on the surface of
the tonometer immediately.
WARNING
Use of any accessories and cables other than those specified in the manufacturer’s documentation, with the exception of cables sold by the manufacturer
as replacement parts for internal components, may result in increased emissions or decreased immunity of the Icare TA01i tonometer.
WARNING
Use of any accessory or cable with the Icare TA01i tonometer other than those specified may result in increased emissions or decreased immunity of the
Icare TA01i tonometer.
CAUTION
Read this manual carefully, since it contains important information on using and servicing the tonometer.
Retain this manual for future use.
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 manufacturer or distributor.
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.
This manual contains instructions for replacing batteries and changing the probe base.
Never use the tonometer in wet or damp conditions.
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 inflammable anesthetic agents.
Prior to each measurement, check that a new disposable probe from an intact package is being used.
Be sure that the probe contains the small plastic round tip in front.
Certain microbiological agents (e.g. bacteria) can be transmitted from the forehead support.
To avoid this, the forehead support should be cleaned regularly with a disinfectant, e.g. an alcohol solution.
The tonometer conforms to EMC requirements (IEC 60101-1-2: 2001), 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, e.g. sensitive sensors.
If the device is not to be used for a long time, we recommend that you remove its AA batteries, since they may leak. Removing the batteries will not affect
the subsequent functioning of the tonometer.
Be sure to dispose of the single-use probes properly (e.g. in a container for disposable needles), because they may contain micro-organisms from the
patient.
Batteries, packaging materials and probe bases must be disposed of according to local regulations.

Icare tonometer TA01i manual English
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4
To obtain firm
support for the
patient’s
forehead, in order
to obtain an
accurate
measurement at
the right distance,
you can adjust the
forehead support
by turning the
forehead support
adjusting wheel.
Open the probe tube by removing
the cap and insert the probe into
probe base as shown in the
image. After the probe has been
inserted, be careful not to point it
down before activating the
tonometer in order to prevent
the probe from falling out.
Activate by pressing the
easurement button once and the
tonometer will be ready for
measurement when 00 appears
on the display. After activating
the probe is magnetized and will
not fall out.
CAUTION
Federal law (U.S.) restricts this device to sale by or on the order of a physician.
PARTS OF THE TONOMETER
TURNING THE TONOMETER ON AND LOADING THE PROBE
Place the wrist strap into the wrist strap attachment. Place the wrist strap around your wrist and secure it. The wrist
strap protects the tonometer from dropping onto the floor accidentally. Insert batteries into the tonometer (page 9).
Press the measurement button to turn the tonometer ON. The tonometer display will display all of the LCD segments
(see the figure beside). Check that all of the segments are functional in the four-digit, sevensegment LCD display.
Following a brief pause, the display will show “LoAd,” reminding the user to load the single use probe into the
tonometer prior to measurement.
Load the probe in the following way:
MEASUREMENT
Since local anesthetic may lower the tonometer reading, we recommend that
you refrain from using an anesthetic when performing measurements.
Ask the patient to relax and look straight ahead at a specific point. Bring the
tonometer near the patient’s eye. The central groove should be in a horizontal
position, and the distance from the eye to the front part of the collar should
be the length of the collar. In other words, the distance from the tip of the
1. Forehead support
2. Forehead support adjusting wheel
3. Display
4. Collar
5. Selector button
6. Measurement button
7. Probe base
8. Central groove

Icare tonometer TA01i manual English
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5
probe to the patient’s cornea (see picture) should be 4-8 mm (1/6-1/3 inch).
If necessary, adjust the distance by turning the forehead support adjusting wheel. 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. Six measurements are made consecutively.
After each successful measurement, you will hear a short beep. Once the six measurements have been performed, the IOP will be shown on the display
after the ‘P’.
If there is an erroneous measurement, the tonometer will beep twice and display an error message. Press the measurement button to clear the error
message. If several erroneous measurements appear, see error messages (page 10).
To obtain the most accurate reading, six measurements are required, but the result is also displayed after the first measurement, which can usually be
considered valid. The measurement values displayed are average values for all previous measurements (1.-5.). Single measurement values are not shown.
Should there be variation between the measurements, ‘P’ will flash on the display after the sixth measurement.
Following the performance of the entire measurement, a new measurement series can be begun by pressing the measurement button. The tonometer will
then be ready for the next measurement series (00 will show on the display, see page 8).
If the user doubts the validity of the measurement (for example, if the probe made contact with the eyelid, or missed the central cornea etc.), we
recommend that he/she make a new measurement. In addition, when encountering unusual values (for example over 22mmHg or below 8 mmHg) we
recommend the performance of a new measurement to verify the result.
*Badouin C, Gastaud P. Influence of topical anesthesia on tonometeric values of intraocular pressure. Ophthalmologica 1994;208:309-313
DISPLAY AFTER MEASUREMENTS
Before After the second measurement After the sixth measurement
00 2.13 P 13
After the sixth measurement, the letter P appears on the display, followed by the IOP (Intraocular pressure) reading.
If the P is blinking, it means that the standard deviation of the measurements is greater than normal.
P_(line down) The standard deviation of the different measurements has a slightly greater value than normally, but the effect on the result is unlikely to
be relevant.
P-(line in the middle) The standard deviation of the different measurements is clearly greater than normal, but the effect on the result is probably
irrelevant. A new measurement is recommended if the IOP is over 19 mmHg.
P–(line up) The standard deviation of the different measurements is great and a new measurement is recommended.
OTHER FUNCTIONS
Accessing old measurement value
From the starting position, press the right or left selector button
until ‘Old’ appears on the display. Then press the measurement
button. You can now ‘scroll’ through the old values by pressing
the selector buttons (right=older, left=more recent, from 0-9).
To exit the old values search, press the measurement button.
The display will now show the word ‘Old’. Press either selector button to access other functions (00=measurement, End=turning OFF).
Turning the tonometer OFF
Press either selector button until the display shows ‘End‘. Press
the measurement button for two seconds - the display will show
‘byE’ and the tonometer will switch off. The used probe will be
partially ejected. Use the used package to remove it from the
tonometer. Ensure that you dispose of the probe properly.
Error messages
To clear error messages, press the measurement button, after which the measurement can be repeated. The following messages may appear: