I-care ic100 User manual

EN INSTRUCTION MANUAL
DE GEBRAUCHSANWEISUNG
ES MANUAL DE INSTRUCCIONES
IT MANUALE DI ISTRUZIONI
SV ANVÄNDARHANDBOK
FI KÄYTTÖOHJE
NO BRUKSANVISNING
PL INSTRUKCJA OBSŁUGI
DA BRUGERMANUAL
PT MANUAL DE INSTRUÇÕES
NL GEBRUIKSAANWIJZING
FR MODE D’EMPLOI
TA011-122-1.0

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Icare ic100 tonometer manual

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Icare ic100 tonometer manual
ENGLISH
Safety instructions ...........................................................................................................................................1
Intended use.....................................................................................................................................................2
Introduction......................................................................................................................................................2
Package contents.............................................................................................................................................2
Parts of the tonometer ...................................................................................................................................3
Installing or changing the batteries ..............................................................................................................3
Turning the tonometer on..............................................................................................................................3
Loading the probe ...........................................................................................................................................3
Probe base light indication.............................................................................................................................3
Measurement...................................................................................................................................................3
Menu functions ................................................................................................................................................5
MEASURE – Access to measurement ..................................................................................................5
HISTORY – Old measurements ............................................................................................................5
SOUND – Setting of Tonometer buzzer..............................................................................................5
LIGHT – Setting of Probe base light ....................................................................................................5
LANGUAGE – Language setting ...........................................................................................................5
INFO – Device information...................................................................................................................5
Turning the tonometer o..............................................................................................................................6
Error and info messages.................................................................................................................................6
Measurement ow chart.................................................................................................................................7
Accessories .......................................................................................................................................................8
Technical information .....................................................................................................................................8
Performance data............................................................................................................................................8
Maintenance.....................................................................................................................................................8
Replacing/cleaning the probe base ...............................................................................................................9
Cleaning the tonometer..................................................................................................................................9
Returning the Icare tonometer for servicing / repair..................................................................................9
Periodic Safety Checks ....................................................................................................................................9
Symbols...........................................................................................................................................................10
Electromagnetic declaration.........................................................................................................................10
Guidance and manufacturer’s declaration–Electromagnetic emissions.................................................11
Guidance and manufacturer’s declaration–Electromagnetic immunity .................................................11
Recommended separation distances between portable and mobile RF communications equipment
and Icare ic100 ...............................................................................................................................................13

1
English
ENGLISH
TONOMETER
Icare® ic100
INSTRUCTION MANUAL
The information in this document is subject to
change without prior notice.
In a conflict situation the English version
prevails.
0598
This device complies with:
Medical Device Directive 93/42/EEC
Canadian Medical Device Regulations
RoHS Directive 2011/65/EU
Copyright © 2017 Icare Finland Oy
Made in Finland
Icare Finland Oy/Tiolat Oy
Äyritie 22, FI-01510 Vantaa, Finland
Tel. [phone], Fax [phone]
www.icaretonometer.com,
info@icarenland.com
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 push the tonometer into the eye (the tip
of the probe should be 4-8mm, or 5/32 - 5/16
inch, from the eye).
WARNING
The tonometer should only be opened by
qualied service personnel. It contains no
userserviceable 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
or changing or cleaning the probe base.
If servicing is necessary, contact qualied
service personnel or your local Icare
representative.
WARNING
Never immerse the Icare tonometer, 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 this equipment adjacent to or stacked
with other equipment should be avoided
because it could result in improper operation.
Ifsuch use is necessary, this equipment and the
other equipment should be observed to verify
that they are operating normally.
WARNING
Use of accessories other than those
specied or provided by the manufacturer
of this equipment could result in increased
electromagnetic emissions or decreased
electromagnetic immunity of this equipment
and result in improper operation.
WARNING
Use only the original and certied probes made
by the manufacturer. The probes are for single-
use (one per testing session) only. Use probes
taken only from the intact, original packaging.
Re-use of the probe could result in incorrect
measurement values, in the breakdown of
the probe, cross-contamination of bacteria
or viruses, and infection of the eye. Re-use
will void all responsibilities and liabilities of
the manufacturer concerning the safety and
eectiveness of the tonometer.
CAUTION
Read this manual carefully, since it contains
important information on using and servicing
the tonometer.
Retain this manual for future use.
Do not use anesthetic to numb the eye, because
no anesthetic is required when performing
measurements and anesthetic can aect the
measurement results.
If you do not use the tonometer, it will switch
o automatically after 3 minutes.
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

2
Icare ic100 tonometer manual
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 if it is broken.
Do not use the device near inammable
substances, including inammable 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, clean the forehead support after
each patient with a disinfectant, e.g. an alcohol
solution.
The tonometer conforms to EMC requirements
(IEC 60101-1-2), 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, 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 aect 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.
No part of the tonometer or probes are made
with natural rubber latex.
INTENDED USE
The Icare ic100 tonometer is intended to be
used for the measurement of intraocular
pressure of the human eye.
INTRODUCTION
The Icare ic100 tonometer is based on a
patented, induction-based rebound method,
which allows intraocular pressure (IOP) to be
measured accurately, rapidly and without an
anesthetic.
The tonometer uses the rebound method. A
small and light single-use probe makes contact
with the eye very briey. The tonometer
measures the deceleration of the probe and
the rebound time, and calculates the IOP from
these parameters.
A measurement sequence includes six
measurements. The probe moves to the
cornea and back during every measurement.
As a result, after the six measurements the
tonometer calculates the nal IOP and stores it
in the tonometer’s memory.
PACKAGE CONTENTS
CAUTION
When you have opened the package, check for
any external damage or aws, particularly for
damage to the case. If you suspect that there is
something wrong with the tonometer, contact
the manufacturer or distributor.
The package contains:
• Icare ic100 tonometer
• 4 x AA batteries
• 100 single use probes in a box
• wrist strap
• silicone grip
• IOP pad
• aluminium case
• screw driver
• additional probe base collar
• probe base cover
• spare probe base
• probe base cleaning container
• quick guide
• USB memory stick including instruction
manuals
• warranty card

3
English
PARTS OF THE TONOMETER
(Figure 1)
1. Forehead support
2. Probe base
3. Collar
4. Display
5. Forehead support adjusting wheel
6. Navigation buttons
7. Measure button
8. Select button
INSTALLING OR CHANGING THE BATTERIES
Unscrew the battery compartment locking
screw with a screwdriver. Remove the battery
compartment cover.
Place the wrist strap into the wrist strap
attachment at the end of the tonometer.
Insert a new set of four AA batteries. Insert the
batteries accordance with Figure 2. Do not use
rechargeable batteries.
Replace the battery compartment cover and
secure it by screwing it in lightly using the
screwdriver (Figure 2). Take care not to use
excessive force when screwing the cover into
place.
TURNING THE TONOMETER ON
Place the wrist strap around your wrist
and secure it. The wrist strap protects the
tonometer from dropping onto the oor
accidentally.
To turn the tonometer on press the Select or
Measure button. The following gures show two
alternative ways of starting the tonometer:
Pressing the Select button
MEASURE
Pressing the Measure button
LOAD
LOADING THE PROBE
Step 1. Remove the probe base cover (do not
dispose of the cover) and open the probe tube
by removing the cap and insert the probe into
the probe base as shown in Figure 3.
Step 2. After loading the probe the tonometer
will be ready for measurement when Play-
symbol appears on the display (Figure 4).
PROBE BASE LIGHT INDICATION
The probe base light serves two purposes.
First, it helps guide alignment of the device by
showing a red light when the device is in the
wrong position (i.e. too much vertical tilt) and
a green light when the orientation is correct.
Second, it indicates errors (see section Error
and Info Messages) in addition to the display
during the measurement sequence. When any
of these errors occurs, the probe base light
ashes red until the error is cleared by pressing
the “Measure” button. The probe base light
ashes red also when the text REPEAT with
the yellow repeat symbol come on the display
indicating a measurement sequence with too
high deviation.
MEASUREMENT
CAUTION
If you do not use the tonometer, it will switch
o automatically after 3 minutes.
CAUTION
No anesthetic is required when performing
measurements. *Since local anesthetic may
lower the tonometer reading, we recommend
that you refrain from using an anesthetic when
performing measurements.
Step 1. Ask the patient to relax and look straight
ahead at a specic point. Bring the tonometer
near the patient’s eye.
Correct head and eye position (Figure 5).
Incorrect head and eye position (Figure 6 and 7).

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Icare ic100 tonometer manual
Step 2. The device should be in a horizontal
position. Keep the probe horizontal and
pointing perpendicularly to the center of the
cornea. The distance from the tip of the probe
to the patient’s cornea (Figure 8) should be 4-8
mm (5/32 - 5/16 inch).
If necessary, adjust the distance by turning the
forehead support adjusting wheel.
Correct alignment of the tonometer and green
probe base light indication (Figure 9).
If probe base light indication is set OFF green
arrows will indicate the correct alignment of the
tonometer (Figure 10).
Incorrect alignment of the tonometer and red
probe base light indication (Figure 11).
If probe base light indication is set OFF red
arrows will indicate the incorrect alignment of
the tonometer (Figure 12).
Step 3. You may perform the measurement in
single or series mode (Figure 13).
Single mode: Press the Measure 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 should be made
consecutively, blue segments will be lit after
every successful measurement. After each
successful measurement, you will hear a short
beep.
Series mode: Keep the Measure button down
to obtain the sequence of six measurements,
blue segments will be lit after every successful
measurement.
To obtain the nal reading, six measurements
are required. The measurement values
displayed before the nal result are average
values for all previous measurements (1.-5.).
Single measurement values are not shown.
TOO NEAR
If there is an erroneous
measurement, the tonometer will beep twice
and display an error message. Press the
Measure button to clear the error message. If
several erroneous measurements appear, see
error messages.
Step 4. Once the six measurements have been
performed, you will hear a long beep. The
nal IOP will be shown on the display rounded
by green (perfect, Figure 14) or yellow (some
variation, Figure 15) segments. If variation is too
big. Repeat will be displayed.
REPEAT
The displayed result is an average of four
measurements as the highest and the lowest
reading are discarded before the average
calculation.
The colors green and yellow as well as repeat
indication are related to the standard deviation
(SD) of the probe’s motion parameters of the
four remaining measurements.
Step 5. Following the performance of the entire
measurement, a new measurement series can
be begun by pressing the Measure button. The
tonometer will then reactivate the probe and
be ready for the next measurement series with
the Play symbol on the display (Figure 16). The
measurement sequence can be aborted by
pressing the Select button. Place the probe base
cover back to cover the probe base when the
tonometer is not in use.
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.), it is recommended that he/she
repeat the measurement. In addition, when
encountering unusual values (for example, very
high or very low values) it is recommended that
a repeat measurement be taken either with the
Icare tonometer or an alternative method to
verify the result.
*Badouin C, Gastaud P. Inuence of topical
anesthesia on tonometeric values of intraocular
pressure. Ophthalmologica 1994;208:309-313.

5
English
MENU FUNCTIONS
(Figure 17)
Scrolling between the Menu functions starts from the MEASURE display, press either of the
Navigation buttons located around the Select button.
Menu functions are MEASURE, HISTORY, SOUND, LIGHT, LANGUAGE and INFO
MEASURE
LOAD
MEASURE – Access to measurement
Press the Select button to access.
If the probe is not loaded the LOAD display appears.
Tonometer is ready for measurement when Play-symbol
display appears.
To exit, press the Select button.
HISTORY
HISTORY – Old measurements
Press the Select button to access.
Scroll through the old values by pressing either of the
Navigation buttons.
Value colors green and yellow are related to Standard
deviation (SD).
To exit, press the Select button.
SOUND
ON ON OFF
SOUND – Setting of Tonometer buzzer
Blue text and symbol is active setting.
Press the Select button to access.
Turn the sound ON and OFF by pressing either of the
Navigation buttons.
To accept selection, press the Select button.
LIGHT
ON ON OFF
LIGHT – Setting of Probe base light
Blue text and symbol is active setting.
Press the Select button to access.
Turn the light ON and OFF by pressing either of the
Navigation buttons.
To accept selection, press the Select button.
LANGUAGE
ENGLISH
SVENSKA DEUTCH
LANGUAGE – Language setting
Blue text is active setting.
Press the Select button to access.
Scroll through the language options by pressing either of the
Navigation buttons.
To accept selection, press the Select button.
INFO
INFO – Device information
Press the Select button to access.
Serial number (SN) of the tonometer.
Software version (SW) of the tonometer.
To exit, press the Select button

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Icare ic100 tonometer manual
TURNING THE TONOMETER OFF
Press the Select button (Figure 18) until the display shows the End-symbol (Figure 19).
If you do not use the tonometer, it will switch o automatically after 3 minutes.
ERROR AND INFO MESSAGES
The following messages may appear on the display:
MESSAGE DESCRIPTION ACTIONS
Battery charge is low. Prepare to replace the batteries.
CHANGE
The batteries are empty. Turn the tonometer OFF by pressing Select button.
Replace the batteries.
CHANGE
The probe did not move. Change the probe. The probe was twisted or
otherwise inserted incorrectly. To clear error
messages, press the Measure button, after which
the measurement can be repeated.
CLEAN
CHANGE
The probe did not move
properly for several times
during the measurement
sequence.
Remove and clean the probe base or replace it
with new one as instructed in Replacing/cleaning
the probe base. To clear error messages, press the
Measure button, after which the measurement can
be repeated.
TOO FAR
The probe did not touch the eye. Adjust correct measurement distance 4-8 mm. The
measurement was taken from too far away.
TOO NEAR
Too short measurement
distance between the probe and
the cornea.
Adjust correct measurement distance 4-8 mm. The
measurement was taken from too close. To clear
error messages, press the Measure button, after
which the measurement can be repeated.
REPEAT
The probe did not move
properly. The probe did not
make clean contact with the
cornea, because the probe hit
an eyelid or eyelashes.
Ensure that the eye is open, measure again. To
clear error messages, press the Measure button,
after which the measurement can be repeated.
SERVICE
Internal error detected. Turn the tonometer OFF by pressing Select button.
Contact the seller to arrange sending the device for
service.

7
English
MEASUREMENT FLOW CHART
Turn Tonometer ON by pressing Select or Measure button
MEASURE
This is displayed if you pressed the Select button, pressing of Measure button
would lead you directly to Load Probe
LOAD
Load Probe
Ready to
measure
Measure 6 times by pressing Measure button (blue color bar
shows theprogress)
Successful
measurement
REPEAT
Repeat the measurement
Tonometer OFF
by pressing
Select button
>3seconds

8
Icare ic100 tonometer manual
Atmospheric pressure: 500 hPa-1,060 hPa
Mode of operation: continuous
PERFORMANCE DATA
The performance data is obtained from
a clinical study, performed according to
American National Standard ANSI Z80.10-
2003 and International Standard ISO 8612.2
for tonometers. The study was performed in
the Department of Ophthalmology, Helsinki
University Central Hospital. In the study, 158
patients were measured. The mean paired
dierence and standard deviation (Goldmann-
Icare) were -0.4 mmHg and 3.4 mmHg. A
scattergram and Bland-Altman plot of the
results is shown in Figure 20.
MAINTENANCE
Follow local regulations and recycling
instructions regarding the disposal or recycling
of the Icare tonometer and accessories.
WARNING
The tonometer should only be opened by
qualied service personnel. It contains no
userserviceable 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
or changing or cleaning the probe base. If
servicing is necessary, contact qualied service
personnel or your local Icare representative.
TECHNICAL INFORMATION
Type: TA011
Dimensions: 24 - 29 mm (W) * 35 - 95 mm (H) *
215 mm (L).
Weight: 140 g (without batteries), 230 g (4 x AA
batteries).
Power supply: 4 x AA non-rechargeable
batteries, 1.5V alkaline LR6.
Measurement range: 7-50 mmHg
Accuracy: ±1.2 mmHg (≤20 mmHg) and ±2.2
mmHg (>20 mmHg).
Repeatability (coecient of variation): <8 %.
Accuracy of display: 1 mmHg.
Display unit: Millimeter of mercury (mmHg).
The serial number is 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.
Operation environment:
Temperature: +10 °C to +35 °C
Relative humidity: 30 % to 90 %
Atmospheric pressure: 800 hPa-1,060 hPa
Storage environment:
Temperature: -10 °C to +55 °C
Relative humidity: 10 % to 95 %
Atmospheric pressure: 700 hPa-1,060 hPa
Transport environment:
Temperature: -40 °C to +70 °C
Relative humidity: 10 % to 95 %
ACCESSORIES
SKU PRODUCT DESCRIPTION WEIGHT DIMENSIONS
104 Box of 100 probes 89 g 53 x 109 x 36 mm
7217 TA011/TV011 collar 4 g 18 x 18 mm
7218 TA011/TV011 collar narrow 1 g 17 x 18 mm
540 Probe base 4 g 7 x 38 mm
559 Wrist strap with lock 4 g 10 x 10 x 270 mm
525 Aluminium case, Icare ic100 800 g 240 x 280 x 72 mm
7169 Battery cover & screw, Icare ic100 6 g 110 x 25 x 12 mm
623 IOP pad, Icare ic100 38 g 50 x 53 x 16 mm
543 Probe base cleaning container 3 g 20 x 56 mm
565 Silicone grip - white, Icare ic100 26 g 45 x 35 x 113 mm
548 Screw driver, Icare 15 g 16 x 90 mm
577 USB memory stick 44 g 98 x 11 x 93 mm
544 Probe base cover 1 g 19 x 11 mm

9
English
REPLACING/CLEANING THE PROBE BASE
(Figure 21)
Replace the probe base every twelve months.
Clean the probe base every six months. Clean
or replace the probe base if the error message
Clean Change is displayed.
Instructions for replacing the probe base:
• Replace every twelve months.
• Turn o the tonometer.
• Unscrew the probe base collar and put it in a
safe place.
• Remove the probe base by tilting the
tonometer downwards and use your ngers
to pull the probe base out of the tonometer.
• Insert a new probe base into the tonometer.
• Screw the collar in, to lock the probe base.
Instructions for cleaning the probe base:
• Clean every six months.
• Fill the probe base cleaning container or
other clean container with 70-100 % isopropyl
alcohol.
• Turn the power o.
• Unscrew the probe base collar.
• Invert the probe base over the container,
drop in the probe base into the container and
let soak for 5–30 minutes.
• Remove the probe base from alcohol.
• Dry the probe base by blowing clean canned
or compressed air into the hole in the probe
base. This will additionally remove possible
residual dirt.
• Insert the probe base into the tonometer.
• Screw the collar in, to lock the probe base.
CLEANING THE TONOMETER
WARNING
Never immerse the Icare tonometer, 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.
Icare ic100’s surfaces have been tested and
found chemically resistant to the following
liquids:
• 70-100 % isopropyl alcohol
• Mild soap solution
• 95 % Pursept solution
Cleaning instructions for surfaces:
• Turn the power o.
• Dampen a soft cloth with one of the liquids
mentioned above.
• Lightly wipe the surfaces of the tonometer
with the soft cloth.
• Dry the surfaces with a dry soft cloth.
RETURNING THE ICARE TONOMETER FOR
SERVICING / 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
accessories along with the tonometer. Use a
suitable carton with the appropriate packaging
material to protect the device during shipment.
Return the device using any shipping method
that includes proof of delivery.
PERIODIC SAFETY CHECKS
We recommend that the following checks be
performed every 24 months.
Equipment inspection for mechanical and
functional damage.
Inspection of safety labels for legibility.
Applicable in Germany only: Messtechnische
Kontrolle nach MPG (Medizinproduktegesetz)
alle 24 Monate.

10
Icare ic100 tonometer manual
SYMBOLS
Attention!!! See instructions
See operating instructions for more
information
Serial number
Single use only
BF-type device
Rx Only Federal law (U.S.) restricts this device to
sale by or on the order of a physician.
LOT Lot number
SN
Manufacturing date
Keep dry
Manufacturer
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)
-10°C
55°C 95%
10%
1060hPa
700hPa
-40°C
70°C 95%
10%
1060hPa
500hPa
Storage environment
Transport environment
Temperature
limits
Humidity
limits
Atmospheric
pressure limits
ELECTROMAGNETIC DECLARATION
WARNING
Use of this equipment adjacent to or stacked
with other equipment should be avoided
because it could result in improper operation.
Ifsuch use is necessary, this equipment and the
othe requipment should be observed to verify
that they are operating normally.
WARNING
Use of accessories other than those
specied or provided by the manufacturer
of this equipment could result in increased
electromagnetic emissions or decreased
electromagnetic immunity of this equipment
and result in improper operation.
TA011 is class B equipment and needs special
precautions regarding EMC and needs to be
installed and put into service according to EMC
information provided in Instruction for use
manual.

11
English
GUIDANCE AND MANUFACTURER’S DECLARATION–ELECTROMAGNETIC EMISSIONS
Icare ic100 (TA011) is intended for use in the electromagnetic environment specied below.
The user of the Icare ic100 (TA011) should assure that it is used in such an environment.
RF emissions CISPR 11 Group 1 Icare ic100 (TA011) is battery operated and
use RF energy only for its internal function.
Therefore, its RF emissions are low and are
not likely to cause any interference in nearby
equipment.
RF emissions CISPR 11 Class B Icare ic100 (TA011) is suitable for use in
all establishments, including domestic
establishments and those directly connected to
public low-voltage power supply network that
supplies buildings used for domestic purposes
Harmonic emissions
IEC 61000-3-2
NOT APPLICABLE
Voltage uctuations
ickering emissions
IEC 61000-3-3
NOT APPLICABLE
GUIDANCE AND MANUFACTURER’S DECLARATION–ELECTROMAGNETIC IMMUNITY
Icare ic100 (TA011) is intended for use in the electromagnetic enviroment specied below.
The customers or users of Icare ic100 (TA011)) should assurre that it is used in such an enviroment
Immunity test IEC 60601 Test level Compliance level Electromagnetic environment-
Guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
± 6 kV contact
±8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete or
ceramic tile. If oors are covered
with synthetic material, the relative
humidity should be at least 30 %
Electrical fast
Transients/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/
output lines
NOT
APPLICABLE
NOT APPLICABLE
Surge
IEC 61000-4-5
±1 kV for line(s) to
line(s)
±2 kV for line(s) to
earth
NOT
APPLICABLE
NOT APPLICABLE
Voltage dips, short
interruption and
voltage variations on
power supply lines
IEC 61000-4-11
<5 % UT (>95 %
dip in UT) for
0,5cycle
40 % UT (60 % dip
in UT) for 5 cycles
70 % UT (30 %
dip in UT) for
25cycles
<5 % UT (>95 %
dip in UT) for 5 s
NOT
APPLICABLE
NOT APPLICABLE
Power frequency
(50/60 Hz) magnetic
eld
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic elds
should be at levels characteristic
of a typical location in a typical
commercial or hospital environment.

12
Icare ic100 tonometer manual
GUIDANCE AND MANUFACTURER’S DECLARATION–ELECTROMAGNETIC IMMUNITY
Icare ic100 (TA011) is intended for use in the electromagnetic enviroment specied below.
The customers or users of Icare ic100 (TA011)) should assurre that it is used in such an enviroment
Immunity test IEC 60601 Test level Compliance level Electromagnetic environment-
Guidance
Radiated RF
IEC 61000-4-3
3 V/m
80MHz to 2,5 GHz
3V/m Portable and mobile RF
communications equipment should
be used no closer to any part of the
Icare ic100 (TA011), including cables,
than the recommended separation
distance calculated from the
equation applicable to the frequency
of the transmitter.
Conducted RF
IEC 61000-4-6
3Vrms
150 kHz to
80MHz
NOT
APPLICABLE Recommended separation distance
d = 1.2 √P
d = 1.2 √P 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2 5 GHz
Where P is the maximum output
power rating of the transmitter
in watts (W) according to the
transmitter manufacturer and d
is the recommended separation
distance in metres (m).
Field strengths from xed RF
transmitters, as determined by an
electromagnetic site survey ashould
be less than the compliance level in
each frequency range b.
Interference may occur in the vicinity
of equipment marked with the
following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by
absorption and reection from structures, objects and people.
a Field strengths from xed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to xed RF transmitters, an electromagnetic site survey should be considered. If the measured
eld strength in the location in which the Icare ic100 (TA011) is used exceeds the applicable RF
compliance level above, theIcare ic100 (TA011) should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting
or relocating the Icare ic100 (TA011).
b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3V/m.

13
English
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF
COMMUNICATIONS EQUIPMENT AND ICARE IC100
Icare ic100 (TA011) is intended for use in an electromagnetic environment in which radiated RF-
disturbances are controlled. The customer or the user of the Icare ic100 (TA011) can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and Icare ic100 (TA011) as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter
(W)
Separation distance according to frequency of transmitter, m
150 kHz to 80 MHz
d= 1.2 √P
80 MHz to 800 MHz
d= 1.2 √P
800 MHz to 2.5 GHz
d= 2.3 √P
0.01 NOT APPLICABLE 0.12 0.23
0.1 NOT APPLICABLE 0.38 0.73
1 NOT APPLICABLE 1.2 2.3
10 NOT APPLICABLE 3.8 7.2
100 NOT APPLICABLE 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in metres (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by
absorption and reection from structures, objects and people.

Handbuch Icare ic100 Tonometer
DEUTSCH
Sicherheitsvorschriften ...................................................................................................................................1
Bestimmungsgemäße Verwendung ..............................................................................................................2
Einleitung ..........................................................................................................................................................2
Lieferumfang....................................................................................................................................................3
Teile des Tonometers .....................................................................................................................................3
Einsetzen oder Auswechseln der Batterien..................................................................................................3
Einschalten des Tonometers..........................................................................................................................3
Einsetzen des Messgebers..............................................................................................................................3
Anzeige der Messgebereinsatzleuchte..........................................................................................................3
Messvorgang ....................................................................................................................................................4
Menüfunktionen ..............................................................................................................................................5
MESSEN – Zugri auf die Messung .....................................................................................................5
VERLAUF – Alte Messungen .................................................................................................................5
TON – Einstellung des Tonometer-Summers ....................................................................................5
LICHT – Einstellung der Messgebereinsatzleuchte ..........................................................................6
SPRACHE – Spracheinstellung..............................................................................................................6
INFO – Geräteinformationen ...............................................................................................................6
Ausschalten des Tonometers.........................................................................................................................6
Fehlermeldungen und Informationen...........................................................................................................6
Flussdiagramm der Messung.........................................................................................................................7
Zubehör.............................................................................................................................................................8
Technische Daten ............................................................................................................................................8
Leistungsdaten.................................................................................................................................................8
Wartung ............................................................................................................................................................9
Austausch/Reinigung desMessgebereinsatzes ...........................................................................................9
Reinigung des Tonometers.............................................................................................................................9
Einsendung des Icare® Tonometers zwecks Wartung/Reparatur...........................................................10
Periodische Sicherheitskontrollen...............................................................................................................10
Symbole ..........................................................................................................................................................10
Elektromagnetische Angaben ......................................................................................................................11
Leitlinien und Herstellererklärung – Elektromagnetische Emissionen ...................................................11
Leitlinien und Herstellererklärung – Elektromagnetische Immunität.....................................................11
Empfohlene Abstände zwischen tragbaren und mobilen RF-Kommunikationsgeräten und
Icare HOME.....................................................................................................................................................14

1
Deutsch
DEUTSCH
TONOMETER
Icare® ic100
GEBRAUCHSANWEISUNG
Die in diesem Dokument enthaltenen
Informationen können ohne Vorankündigung
geändert werden.
Bei Widersprüchen zwischen den
Sprachversionen ist die englische Fassung
maßgeblich.
0598
Dieses Gerät entspricht:
Richtlinie 93/42/EWG für medizinische Geräte
Canadian Medical Device Regulations
RoHS-Richtlinie 2011/65/EU
Copyright © 2017 Icare Finland Oy
Hergestellt in Finnland
Icare Finland Oy/Tiolat Oy
Äyritie 22, FI-01510 Vantaa, Finnland
Tel. [phone], Fax [phone]
www.icaretonometer.com,
info@icarenland.com
SICHERHEITSVORSCHRIFTEN
WARNUNG
Das Tonometer darf nicht mit den Augen
desPatienten in Berührung kommen. Lediglich
der Messgeber darf die Hornhaut während
der Messung für den Bruchteil einer Sekunde
berühren.
Drücken Sie das Tonometer nicht direkt an
dasAuge (der Messkopf sollte 4-8mm vom
Auge entfernt sein).
WARNUNG
Das Tonometer darf nur durch qualiziertes
Fachpersonal geönet werden. Es enthält
keine Komponenten, die vom Benutzer
gewartet werden können, mit Ausnahme
der Batterien und des austauschbaren
Messgebereinsatzes. Das Icare Tonometer
erfordert keine routinemäßigen Wartungs-
oder Kalibrierungsmaßnahmen außer dem
Batteriewechsel (mindestens alle 12 Monate)
und dem gelegentlichen Auswechseln oder
derReinigung des Messgebereinsatzes.
Sollten anderweitige Wartungsmaßnahmen
erforderlich sein, wenden Sie sich bitte an den
Kundendienst von Icare Finland oder an Ihren
örtlichen Fachhändler.
WARNUNG
Tauchen Sie das Icare-Tonometer niemals
in Flüssigkeit ein und vermeiden Sie ein
Besprühen, Begießen oder Verschütten von
Flüssigkeiten auf das Icare-Tonometer, seine
Zubehörteile, Anschlüsse, Schalter oder
Gehäuseönungen. Wischen Sie eventuelle
Spritzer auf der Oberäche sofort ab.
WARNUNG
Die Verwendung dieses Geräts neben oder
gestapelt auf anderen Geräten sollte vermieden
werden, da dies zu unsachgemäßer Bedienung
führen kann. Sollte eine derartige Verwendung
notwendig sein, sind dieses Gerät und andere
Geräte zu beobachten, um deren normalen
Betrieb zu überprüfen.
WARNUNG
Die Verwendung von Zubehör, das nicht
speziziert oder vom Hersteller dieses Geräts
zur Verfügung gestellt wurde, könnte zu
erhöhter elektromagnetischer Strahlung oder
zu verminderter elektromagnetischer Immunität
dieses Geräts und zu unsachgemäßer
Bedienung führen.
WARNUNG
Verwenden Sie nur die vom Hersteller
produzierten und zertizierten Original-
Messgeber. Die Messgeber sind nur für die
einmalige Verwendung bestimmt (Eins pro
Messvorgang). Verwenden Sie nur Messgeber
aus unversehrten Originalverpackungen.
Eine Wiederverwendung des Messgebers
kann zu falschen Messergebnissen, Defekt
des Messgebers, Kreuzkontamination durch
Bakterien oder Viren und zu einer Infektion des
Auges führen. Bei einer Wiederverwendung
verfällt die Verantwortung und Haftung des
Herstellers bezüglich der Sicherheit und
Wirksamkeit des Tonometers.
ACHTUNG
Bitte lesen Sie dieses Handbuch sorgfältig
durch. Es enthält wichtige Informationen zur
Bedienung und Wartung des Tonometers.
Bewahren Sie das Handbuch für die zukünftige
Verwendung auf.

2
Handbuch Icare ic100 Tonometer
Betäuben Sie das Auge nicht mit
Betäubungsmittel, da bei der Durchführung
der Messungen keine Betäubung erforderlich
ist und diese die Messergebnisse beeinussen
könnte.
Wenn das Tonometer länger als drei Minuten
nicht verwendet wird, schaltet es sich
automatisch ab.
Kontrollieren Sie das Gerät nach dem Önen
der Verkaufspackung auf sichtbare Schäden,
insbesondere am Transportkoer. Falls Sie
eine Beschädigung des Tonometers vermuten,
wenden Sie sich bitte an den Hersteller oder
Vertragshändler.
Verwenden Sie das Tonometer ausschließlich
zur Messung des intraokularen Drucks. Jegliche
anderweitige Verwendung ist zweckwidrig.
Der Hersteller kann nicht für direkte oder
Folgeschäden haftbar gemacht werden, die aus
dem unsachgemäßen Gebrauch des Geräts
resultieren.
Önen Sie niemals das Gehäuse des
Tonometers, mit Ausnahme des Akkufachs.
Der Messgebereinsatz kann bei Bedarf
ausgewechselt werden.
Anweisungen zum Auswechseln der Batterien
und des Messgebereinsatzes nden Sie in
diesem Handbuch.
Verwenden Sie das Tonometer niemals in
nasser oder feuchter Umgebung.
Messgebereinsatz, Batteriefachabdeckung,
Schrauben, Manschette und Messgeber sind
Kleinteile, die verschluckt werden können.
Bewahren Sie das Tonometer außer Reichweite
von Kindern auf.
Verwenden Sie das Gerät nicht, wenn es kaputt
ist.
Verwenden Sie das Gerät nicht in der Nähe
entzündlicher Substanzen, einschließlich
brennbarer Betäubungsmittel.
Vergewissern Sie sich vor jeder Messung,
dass ein neuer Einweg-Messgeber aus einer
unbeschädigten Packung eingesetzt wurde.
Überprüfen Sie, dass der Messgeber die kleine
runde Plastikspitze (den eigentlichen Messkopf)
enthält.
Die Stirnstütze kann mikrobiologische Keime
(z.B. Bakterien) übertragen. Um dies zu
vermeiden ist die Stirnstütze regelmäßig nach
jedem Patienten mit einem Desinfektionsmittel,
z.B. einer Alkohollösung, zu reinigen.
Das Tonometer entspricht den EMV-
Anforderungen (IEC 60101-1-2), doch
Interferenzen sind möglich, falls das Instrument
in unmittelbarer Nähe (< 1m) eines Geräts
verwendet wird, das starke elektromagnetische
Strahlung emittiert (z.B. Mobiltelefon). Obwohl
die vom Tonometer selbst ausgehende
elektromagnetische Strahlung deutlich
unter dem in den diesbezüglichen Normen
zugelassenen Wert liegt, besteht die Möglichkeit
von Interferenzen mit in der Nähe bendlichen
Geräten wie z.B. empndlichen Sensoren.
Falls Sie das Gerät längere Zeit nicht verwenden,
sollten Sie die Batterien herausnehmen, da
diese sonst auslaufen können. Das Entfernen
der Batterien schadet der Funktionsweise des
Tonometers in keiner Weise.
Die Einweg-Messgeber müssen nach dem
Gebrauch sachgerecht entsorgt werden (z.B.
in einem Sammelbehälter für gebrauchte
Spritzen), da sie vom Patienten stammende
Mikroorganismen enthalten können.
Batterien, Verpackung und Messgeber müssen
gemäß den örtlichen Bestimmungen entsorgt
werden.
Kein Teil des Tonometers oder Messgebers
wurde aus Naturkatuschuklatex hergestellt.
BESTIMMUNGSGEMÄSSE VERWENDUNG
Das Icare ic100 Tonometer dient zum Messen
des intraokularen Drucks im menschlichen
Auge.
EINLEITUNG
Das Icare ic100 Tonometer basiert auf
einem patentierten Rückprallverfahren auf
Induktionsbasis, mit dem der intraokulare
Druck (IOD) akkurat, schnell und ohne
Betäubung gemessen werden kann.
Das Tonometer verwendet das
Rückprallverfahren. Ein kleiner, leichter Einmal-
Messgeber berührt das Auge sehr kurz. Das
Tonometer berechnet den IOD anhand der
Rückpralldauer und der Verlangsamung des
Messgebers.
Eine Messsequenz besteht aus sechs
Messungen. Dabei berührt der Messgeber jedes
Mal kurz die Hornhaut und prallt wieder zurück.
Infolgedessen berechnet das Tonometer nach
den sechs Messungen den endgültigen IOD-
Wert und speichert diesen im Speicher des
Tonometers ab.