TiOLAT iCare Operating instructions

TONOMETER
User’s and Maintenance Manual
®
V2. 6/03

Introduction
The ICare
®
tonometer is used in the diagnosis, follow
up, and screening of glaucoma.
The ICare
®
is based on the new patented induction
based rebound method, which allows intraocular pressure
(IOP) to be measured accurately, rapidly and without an
anaesthetic.
There is no risk of microbiological contamination, as
one-use probes are used in the measurement.
Intraocular pressure changes due to the effects of
pulse, breathing, eye movements, and body position.
Because the measurement is made handheld in fractions
of a second, several measurements are needed to obtain
an accurate reading. The software is pre-programmed for
six measurements, but the result can be seen from the
first successful measurement.
The ICare
®
is CE-approved.
Introduction
Parts of the tonometer 2
Loading a new disposable probe 3
Turning the device on and magnetizing the probe 4
Adjustment of the forehead support 4
Measurement 5
Other functions 6
Accessing old measurement values 6
Turning the tonometer off 6
Safety instructions 7
Replacing the probe base 8
Replacing the batteries 9
Error messages 0
Service 0
Technical information
Spare parts and supplies
Diagram of tonometer functions
1
Contents

Forehead support
adjustment wheel
arts of the tonometer
Display
Selector button
left / right
Grip
Battery
compartment
Collar
Central groove
Forehead support
Measurement
button
2

Turn to the device and the probe
package at the same time, so that
the probe package is uppermost.
Check that the probe has dropped
into the probe base before
removing the package.
The probe in the probe base.
Open the disposable package.
Place the opened disposable pack-
age against the collar component.
Hold the disposable probe in your
hand, open the package, and load the
probe into the sensor base, according
to the illustrations.
Loading a new
disposable probe
Accurate measurement is guaranteed
only when using probes made by
Tiolat Oy.
3

The device is ready for measure-
ment when the reading 00
appears in the display.
If the display shows the message
LoAd, there is either no probe in
the device, or the probe is stuck.
Check that the probe has not
dropped out, or press the func-
tion button again.
Raise the device to the vertical
operating position, ensuring
that the probe cannot fall out
of the probe base. Press the
measurement button. The
probe will be magnetized by
moving back and forward for a
short time, and the mechanism
that prevents the probe drop-
ping out accidentally will start.
Turning the device ON and
magnetizing the probe
4
Adjusting the
forehead support
The forehead support can be
adjusted back and forward by
turning the adjustment wheel.
This allows the correct measure-
ment distance to be set for each
individual.

Before
00
After the second
measurement
2.13
After the sixth measure-
ment.
P 13
Measurement
The measurement should be done without anesthetic, because an anesthetic
may reduce the tonometer reading*.
Ask the subject to relax and look straight ahead to a specific point. Bring the
tonometer near to the subject’s eye. The central groove should be in a horizontal
position. The distance from the eye to the front part of the collar is the lenght of
the collar. The distance should be 4-8 mm from the tip of the probe to the cornea
of the eye. If necessary, adjust the distance by turning the forehead-support
adjustment wheel.
Measure takes place by lightly pressing the measurement button. The tip of
the probe should hit the central cornea. Six measurements are made consecutive-
ly. Press the measurement button carefully, to avoid shaking the tonometer. After
each successful measurement there is a short beep. After the six measurements,
the IOP is shown on the display after the P letter.
If there is an erroneous measurement, the tonometer will beep twice and
show an error message (page 0). Press the measurement button to clear the
error message. If several erroneous measurements appear, see the section ”Error
messages” (page 0).
Display after the measurements:
5
After the sixth measurement, the letter P appears in 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 different measurements is slightly bigger
value than normally, but the effect to the result is not likely to be relevant.
P_(line in the middle) The standard deviation of different measurements is clearly
greater than normal, but the effect on the result is usually not relevant. A new
measurement is recommended if the IOP is more than 9 mmHg.
P_(line up) The standard deviation of different measurements is great and a new
measurement is recommended.
*
Badouin C, Gastaud P. Influence of topical anesthesia on tonometeric values of intraocular pressure. Ophthalmologica 994;208:309-3 3

Other functions
Accessing old measurement
values.
Starting position
Press the right or left selector button until Old
appears on the display. Then press the measure-
ment button. The old values can now be scanned
back and forward by pressing the selector buttons
(right= older, left=recent)
Press the measurement button to exit the old
values search. Old is on the display. Press either of
the selector buttons to access the other functions
(00=measurement, End=turning OFF).
Turning the tonometer
OFF
Press either of the selector buttons until the
display shows End.
Press the measurement button for two seconds -
The display shows ByE and the tonometer turns
off. The used probe is ejected from the tonometer
Be careful to dispose of the probe properly (p.7)
The tonometer turns off automatically after two
minutes idle time.
6

Safety instructions
Read this manual carefully, because it contains important information on
using and servicing the tonometer.
• Keep this manual for future use.
• When you have opened the package, check for any external damage
or faults. Check especially that the casing is not damaged. If you suspect
that there is something wrong with the tonometer, contact the manufac-
turer or the distributor.
•Use the tonometer only for measuring intraocular pressure. Any other
use is incorrect. The manufacturer cannot be held responsible for any
damage arising from improper use, or for the consequences thereof.
•Never open the casing of the tonometer, except for the battery com-
partment or to change the probe base.
• The manual contains instructions for replacing batteries and changing
the probe base.
• Never use the tonometer in wet place.
•The probe base, battery compartment cover, 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 the substances that are flammable -
including flammable anaesthetic agents.
•Check that a clean new disposable probe is used before each meas-
urement.
•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 must not come into contact with the eye, except for
the probes for a fraction of a second during the measurement, therefore
Do not bring the tonometer into contact with the eye or push it to the
eye (tip of the probe should be 4-8mm from eye).
•The tonometer conforms to EMC requirements (IEC 60 0 - -2: 200 ),
but interference may occur in it if used near to (< m) a device causing
high-intensity electromagnetic emissions (like a cellular phone). Though
the tonometer’s own electromagnetic emissions are well below the levels
in the relevant standards, they may cause interference in another device,
e.g. a sensitive sensor, nearby.
•If the device is not to be used for a long time, removing the batteries
is recommended, as the AA batteries may leak. Removing the batteries
will not affect the subsequent functioning of the tonometer.
•Be sure to dispose of the one-use probes properly (e.g., in a container
for disposable needles), because they may contain micro-organisms from
the measured patient.
•Batteries, packaging materials, and probe bases must be disposed of
according to local regulations.
PL 29, 0066 Helsinki, Finland
fax [phone], e-mail: [email protected]
internet: www.tiolat.fi 7
T O LATOY

Unscrew the probe base collar and
put it in a safe place.
Remove the probe base by tilting the
tonometer downward and pull the
probe base out of the tonometer.
Put a new probe base into the
tonometer.
Screw the collar in, to lock the probe
base.
Replacing the probe base
After several months of use, dust may collect in the probe base,
affecting the probe movement. The probe base should be replaced if
the probe no longer moves smoothly.
8

Replacing the
batteries
Unscrew the battery compartment
locking screw with a screwdriver or a
small coin.
Remove the battery compartment
cover.
Remove the old batteries.
Put new AA batteries into the tonome-
ter according to figures inside the
battery compartment.
+terminals should be down on the
display side of the tonometer (behind).
-terminals should be up on the
measurement side (the front side).
Replace the battery compartment
cover and secure it in place by
screwing it lightly with the coin or
screwdriver. Be careful not to use
excessive force when screwing the
cover in place.
9

Error messages:
Press the central button to clear error messages, after which the
measurement can be repeated.
The following messages may appear:
•bAtt ........................... the batteries are low. Replace the batteries
•E 0 ........................... The probe did not move at all.
If this error message is repeated, turn the tonometer so that the col-
lar faces down for a short time. If the error message is still repeated
take out the probe and replace with a new one. If the error message
continues to appear, replace the probe base.
• E02 .............................The probe did not touch the eye.
The measurement was made from too far away or the probe base is
dirty.
•E03 ..............................Probe speed was too low.
The measurement was made from too far away or the tonometer
was tilted upwards too much.
•E04 ..............................Probe speed was too high.
The tonometer was tilted downwards. Be sure the groove is in the
horizontal position.
•E05 ...............................The hit was too "soft"
The probe hit the eyelid.
•E06 ................................The hit was too "hard"
The probe hit the opening eyelid or calcification in the cornea.
•E07 ................................"Bad bounce"
The probe did not hit the central cornea.
Service procedures
•Replace the batteries when the <bAtt> message appears.
•Change the probe base if the probe does not move smoothly.
•There are no other service procedures that can be carried out by
the user. All other servicing and repairs must be carried out by the
manufacturer or certified service facilities.
•The device can be cleaned with a damp cloth containing
desinfectant.
10

Technical information
Type: TA0 .
The device conforms to CE regulations.
Dimensions: 3 – 32 mm (W) * 45 – 80 mm (H) * 230 mm (L).
Weight: 55 g (without batteries) , 250 g (4 x AA batteries).
Power supply: 4 x AA batteries.
Measurement range: -99 mmHg.
Accuracy of display: .
Measurement accuracy: 2.8 (5-30 mmHg), 5% (30-80 mmHg).
Display unit: Millimetre mercury (mmHg).
The serial number is on the back of the battery compartment cover.
There are no electrical connections from the tonometer to the patient.
The device has B-type electrical shock protection.
Storing/transportation environment
Temperature +5 to +40 °C
Spare parts and supplies
•Probes in one-use package
•Probe base replacement kit
11
Tonometer ON Ready for measurement Old values search Turning OFF
Shutdown
OLD00 END 00
. 8
5. 8
P. 8
P0 8
P9 8
Earlier measurement
values (0-9)
Final result
Central button (measure, confirm)
selecting buttons (left and right)
Diagram of tonometer functions
0537
▲
!CAUTION -Indicates that important operating instructions are
included in this User’s and Maintenance Manual.
Rel. humidity 0 to 80 % (without condensation)