I-care Icare HOME TA022 User manual

EN INSTRUCTION MANUAL
DE BEDIENUNGSANLEITUNG
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
TA022-088-3.1

Icare HOME Instruction Manual ENGLISH
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Icare HOME Instruction Manual ENGLISH
ENGLISH
1. Safety instructions............................................................................................1
2. Glossary.............................................................................................................3
3. Indications for use............................................................................................3
4. How does the tonometer work ......................................................................3
5. Contraindications.............................................................................................4
6. Risks...................................................................................................................4
7. Benefits..............................................................................................................4
8. Package contents .............................................................................................4
9. Before you start................................................................................................4
10. Setting up the tonometer................................................................................5
10.1 Installing or changing the battery ........................................................5
10.2 Turning the tonometer on ...................................................................5
10.3 Loading the probe..................................................................................5
11. Using the tonometer........................................................................................5
11.1 Choosing the measurement mode......................................................5
11.2 Automatic eye recognition....................................................................6
11.3 Adjusting the measurement position..................................................6
11.4 Taking the measurements ....................................................................6
12. Transferring the measurement data .............................................................7
13. Troubleshooting...............................................................................................7
14. Replacing the probe base................................................................................8
15. Cleaning and disinfection................................................................................9
16. Accessories, detachable parts and other supplies.......................................9
17. Lifetime..............................................................................................................9
18. Technical and performance data ...................................................................9
19. Symbols .......................................................................................................... 10
20. Electromagnetic declaration........................................................................ 11
21. Training........................................................................................................... 13

1
www.icaretonometer.com
Icare Finland Oy
Äyritie 22, 01510 Vantaa
Tel. [phone], Fax [phone]
www.icaretonometer.com, [email protected]
1. SAFETY INSTRUCTIONS
WARNING!
Do not push the tonometer into the eye (the tip of the probe should be
4-8mm, or 5/32-5/16”, from the eye). Never use a probe that has no plastic tip.
WARNING!
Keep the tonometer out of the reach of children and pets, because the probe
base, battery compartment cover and probes are so small that a child could
swallow them.
WARNING!
The probes are for single-use only, and are packed sterile.
WARNING!
To prevent contamination, do not touch the bare probe, do not use a probe if
it touches a non-sterile surface like a table or a floor.
WARNING!
Health care professionals must inform patients not to modify or discontinue
their treatment plan without receiving instructions from the health care
professional.
WARNING!
For cybersecurity do not connect to the USB port except when uploading
patient measurement data. Also the tonometer does not allow you to take any
measurements when the USB is connected. All other traditional cybersecurity
controls (anti-virus software, malware software, separate network for the
device, etc.) do not apply since the device is stand alone, is not networked,
anddoes not contain operating system software.
WARNING!
Do not change the batteries or probe base when the USB cable is connected.
WARNING!
No modification of this equipment is allowed.
WARNING!
Use only the original and certified probes made by the manufacturer.
Theprobes are for single-use (single pair of measurement sequences) only.
Use probes taken only from the intact, original packaging. The manufacturer
cannot guarantee sterility of the probe once the seal is compromised.
Re-sterilization or 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-sterilization or re-use will void all
responsibilities and liabilities of the manufacturer concerning the safety and
effectiveness of the tonometer.
WARNING!
Use of accessories, transducers and cables other than those specified 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.
ENGLISH
Icare® HOME (Model: TA022) INSTRUCTION MANUAL
The information in this document is subject to change without prior notice.
In a conflict situation the English version prevails.
This device complies with: Medical Device Directive 93/42/EEC
Canadian Medical Device Regulations
RoHS Directive 2011/65/EU
Copyright © 2020 Icare Finland Oy
Made in Finland
0598

2Icare HOME Instruction Manual ENGLISH
WARNING!
Never immerse the Icare tonometer in liquid. Do not spray, pour or spill liquid
onto the Icare tonometer, its accessories, connectors, switches or openings
inthe chassis. Remove any liquid appearing on the surface of the tonometer
at once.
WARNING!
The tonometer should only be opened by qualified service personnel.
Itcontains no user-serviceable parts, apart from the batteries and a probe
base. The Icare tonometer requires no routine servicing or calibration other
than changing the batteries at least every 12 months and the probe base
every 6 month. If there is reason to believe servicing of the device is necessary,
contact qualified service personnel or your local Icare representative.
WARNING!
In the event of battery short circuit, the batteries and the device handle could
get hot and there is a possible risk of a burn if touched. In such case the
device handle could heat up to 60°C and batteries up to 90°C and the device
should not be used.
WARNING!
When reading the measurement data in a clinic or hospital environment make
sure the tonometer and the PC/mobile device are located a minimum of 1.5 m
from the patient.
WARNING!
Do not use the tonometer in the restricted environments defined in Chapter
18 of this manual.
WARNING!
Do not connect anything to the USB port but the USB cable supplied with the
tonometer.
WARNING!
For assistance, if needed, in setting up, using or maintaining the tonometer
or to report unexpected operation or events, contact the manufacturer
orthemanufacturer's representative.
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!
Sources of power frequency magnetic field should be used no closer than
15cm (6 inches) to any part of Icare HOME (TA022), including cables specified
by the manufacturer. Otherwise, degradation of the performance could result.
PRECAUTION!
• 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 who sold the
tonometer to you.
• Use the tonometer only for measuring intraocular pressure. Any other use
is improper and the manufacturer is not liable for any damage arising from
improper use, or for the consequences of such use.
• Never open the casing of the tonometer, except for the battery compartment.
• Never allow the tonometer to get wet.
• Do not use the tonometer near flammable substances, including flammable
anesthetic agents.
• Certain microbiological agents (for example, bacteria) can be transmitted
from the forehead or cheek support. To prevent this, clean the forehead
and cheek support for each new patient with disinfectant. See the chapter
'Cleaning and disinfection'.
• The tonometer conforms to EMC requirements (IEC 60601-1-2), but
interference may occur within the tonometer if used near (<1m) a device
causing high intensity electromagnetic emissions, such as a cellular phone.
Although the tonometer's own electromagnetic emissions are well below

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the levels permitted by the relevant standards, they may cause interference
in other, nearby devices, for example sensitive sensors.
• If you do not use the tonometer for a long time, remove the batteries, as
they may leak.
• Be sure to dispose of the single-use probes properly (for example, in a mixed
waste bin).
• Batteries, packaging materials and probe bases must be disposed of
according to local regulations.
• Make sure you use batteries with built-in PTC protection, for example
Energizer Lithium Photo 123 3V CR123A.
• Do not cover the eye recognition transmitters or sensor during the
measurement, for example with your fingers. Keep your hand, hair etc.
and objects such as pillows away from the temple side of your eye, as they
produce an infrared reflection that causes an error.
• The tonometer turns off automatically after 3 minutes if you do not use it.
• Update the tonometer's time to your local time. It is done automatically
byperforming the steps 1 and 2 under section 12. Reading the
measurement data.
• Check that the silicone lid covers the USB port during the measurement.
• The measurement method of the Icare HOME tonometer is based on
magnetic induction and therefore an external magnetic field in line with
the probe may prevent the measurement. In such case the tonometer
will continuously ask to repeat the measurement. Situation can be solved
either by removing the source of interference from the vicinity of the
deviceor by performing the measurement in different location with no
suchinterference.
2. GLOSSARY
Tonometer= a device for measuring your IOP
mmHg= units of measurement for the pressure in your eye
Position tag= support positions for your eyes are written on it
Probe= tonometer's single-use item that lightly touches your eye
Probe base light= light ring that assists you to position the probe
Shelf life= the time the probe remains sterile in its intact packing
Cornea= the eye's outermost dome shaped clear layer
Forehead/cheek supports= tonometer's adjustable supports
Expected service life= expected life time before replacement
3. INDICATIONS FOR USE
The Icare HOME tonometer is intended for monitoring of intraocular pressure
(IOP) of the human eye. It is indicated for use by patients or their caregivers
under supervision of an eye care professional.
4. HOW DOES THE TONOMETER WORK
The tonometer measures your eye pressure using a disposable probe that
gently contacts your eye during the measurement. You may need a mirror to
help you determine the correct measurement position. The recommended
frequency of measurements is according to the healthcare professional's
instruction or 3-6 times per day.
A complete measurement is a series of six very rapid measurements. It may
take from several seconds to a minute to take the measurement. The probe
moves to the cornea and back during each of the six rapid measurement.
After the series of six measurements, the tonometer calculates your final
eyepressure and stores it in the tonometer's memory.
The probe is disposable. You can use the same probe for both eyes if the
health care professional instructed you to measure both eyes. After you have
taken the measurements for both eyes place the probe back in its container
and dispose of it in a mixed waste bin.
The tonometer includes infra-red eye recognition sensors to identify which eye,
right or left, you are measuring. It is important not to cover these sensors with
your fingers, hand, hair etc., because covering the sensors causes an error.
Itisalso important to keep objects such as pillows away from the temple side
of your eye, as they produce an infrared reflection that causes anerror.
Do not take the device into use before you have been trained in its use.
Donot modify or discontinue your treatment plan without receiving guidance
from a health care professional.

4Icare HOME Instruction Manual ENGLISH
The Essential Performance of the Icare HOME (TA022) tonometer is to
measure the intraocular pressure (IOP) with specified accuracy (section 18)
and transfer the data (section 12).
5. CONTRAINDICATIONS
You should not use the HOME tonometer if you:
1. Have an active ocular infection (for example, pink eye)
2. Had recent trauma to your eye
3. Have disabling arthritis or difficulty handling the Icare tonometer
4. Have a severe difficulty in opening your eyes including abnormal
contractions or twitches of the eyelid
5. Have involuntary, rapid and repetitive movement of the eyes
6. RISKS
You may not be eligible for use of the HOME tonometer if you:
1. Have poor uncorrected near vision
2. Have only one working eye
3. Have poor or off-center visual fixation
4. Have poor hearing without an aid and/or communicate using sign
language
5. Use contact lens
6. Have dry eyes
7. Have Keratoconus (a corneal disorder)
8. Have a congenitally (from birth) small eye
9. Have an enlarged eye from childhood glaucoma
The safety and effectiveness of the Icare HOME tonometer has not been
evaluated for patients with:
1. High corneal astigmatism
2. History of prior invasive glaucoma surgery or corneal surgery including
corneal laser surgery (for example, LASIK)
3. Corneal scarring
4. Very thick or very thin corneas
5. Patients for whom there is already difficulty in obtaining clinical IOP
measurements (for example, due to eyelid squeezing or tremor)
7. BENEFITS
You can take measurements of your eye pressure at various times during the
day and night with the Icare HOME tonometer. These measurements taken
outside your office visits may help your doctor better understand your eye
pressure, especially if you already have a glaucoma diagnosis.
8. PACKAGE CONTENTS
The package contains:
• Icare HOME tonometer
• 10 sterilized single-use probes
• 2 batteries
• USB memory stick including the instruction manual
• USB cables
• Support position tags
• Warranty card
• Carrying case
• Wrist strap
• Spare probe base
9. BEFORE YOU START
Find the main parts, buttons and indicator lights of the tonometer. The figures
are located at the beginning of this document.
FRONT PARTS (Figure 1)
1. Probe base incorporating indicator light
2. Eye recognition transmitter
3. Eye recognition sensor
4. Cheek support
5. Forehead support

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TOP PARTS (Figure 2)
6. Measurement button
7. Forehead support position indicator
SIDE PARTS (Figure 3)
8. Forehead support adjustment wheel
9. Cheek support adjustment wheel
BOTTOM PARTS (Figure 4)
10. Battery cover
11. Silicone lid (USB cover)
12. Type label
BACK PANEL (Figure 5)
13. Measurement button
14. LOAD light
15. MEASURE light
16. REPEAT light
17. DONE light
18. SERVICE light
19. BATTERY light
20. POWER button
10. SETTING UP THE TONOMETER
Setting up your Icare HOME tonometer is easy, with few steps. The following
subchapters describe how you get started.
10.1 INSTALLING OR CHANGING THE BATTERY
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
the Figure 6.
1. Silicone lid
2. Battery cover
Insert two CR123A lithium batteries in the correct order: (+) end upwards
asshown in the figure left. Close the cover firmly and press the silicone lid in
place to cover the USB port.
10.2 TURNING THE TONOMETER ON
Press the power button (20) to turn the tonometer on. The lights (14-19) are
turned on briefly. Following a brief pause, the Load light flashes on the back
panel to remind the user to load the single-use probe into the tonometer
priorto measurement.
10.3 LOADING THE PROBE
The Icare HOME tonometer uses single-use probes that are packed in a
plastictube and wrapped in blister packs as shown in the Figures 8 and 9.
To load the probe:
1. Unwrap the probe (Figure 10).
2. Remove the lid of the probe container as shown in the Figure 11.
Pointthe tonometer upward.
3. Drop the probe into the probe base by turning the probe container
upside down as shown in the Figure 12.
4. Press the measurement button briefly (1 second) to activate the probe
(Figure 13).
5. The probe moves rapidly back and forth (Figure 14).
6. If the green Measure light flashes, the probe is loaded correctly and
ready for measurement (Figure 15).
11. USING THE TONOMETER
11.1 CHOOSING THE MEASUREMENT MODE
The tonometer can operate in two modes:
Series mode
In the series mode, keeping the button pressed down (see Figure 16) initiates
the measurement function, and the tonometer takes six rapid measurements

6Icare HOME Instruction Manual ENGLISH
one after the other to obtain the final IOP reading. The button must be
pressed for at least 3 seconds.
Single mode
You can use the single mode to take individual measurements one at a time.
The single mode is especially useful for those patients who tend to blink
heavily. Here you press the measurement button briefly (1 second) for each
ofthe six measurements to obtain the final IOP reading (Figure 17).
11.2 AUTOMATIC EYE RECOGNITION
The tonometer includes an automatic eye recognition system that identifies
which eye, right or left, you are measuring. The system has two infrared
LED transmitters just below the probe base and one infrared LED sensor
above theprobe base, as in Figure 21. The right-hand transmitter sends
invisible infrared light to the right and the left-hand transmitter to the left.
Theinfraredlight reflects from your nose to the sensor. The sensor knows
from which transmitter the reflected infrared light came, and thus which
eye you are measuring. The resulting eye indication is included in the data
that you can transfer, as described in the section 11. Do not cover the eye
recognition sensors, because covering the sensors causes an error.
EYE RECOGNITION COMPONENTS (Figure 21)
1. Left and right infrared transmitter
2. Infrared sensor
11.3 ADJUSTING THE MEASUREMENT POSITION
The tonometer has two adjustable supports (see points 4 and 5 in Figure 1),
one for the forehead and one for the cheek, as shown in Figure18.
The supports are for ensuring accurate measurement distance and alignment.
To adjust the measurement position:
1. Adjust the supports using the adjustment wheels as shown in Figure 18.
2. Keep the probe horizontal and pointing perpendicularly to the center of
the cornea.
3. Set the distance between the tip of the probe and the center of the
cornea to be 4-8mm (5/32-5/16”) as shown in Figure 19.
4. Read the distance setting (forehead A•1, A•2, etc., cheek B•1, B•2,
etc.) between the arrows on the scale (see point 7 in Figure 2) of the
supports (see Figure 20) and write it down on a support position tag for
a reference if the setting is changed. The support position tag is found in
the Icare tonometer carrying case.
5. Do the same for the other eye unless only one eye needs monitoring.
6. Regularly verify that the support positions are correct. If the distances
are incorrect during measurement, there will be error indications
(section 13).
11.4 TAKING THE MEASUREMENTS
The probe will make a gentle and brief contact with the eye when you take the
measurement. No topical anesthetic is needed. The recommended frequency
of measurements is 3-4 daily with a maximum of 5-6.
To measure intraocular pressure:
1. Check that the MEASURE light still flashes on the back panel.
2. If the MEASURE light does not flash, press the power button and wait
until the MEASURE light illuminates again.
3. Look straight ahead at a specific point while keeping eyes wide open as
shown in Figure 22.
4. Bring the tonometer near the eye, the probe pointing perpendicular to
the center of the cornea without a vertical or horizontal tilt. The position
is correct when the probe base light is green and appears symmetrically
in the center of your view. See Figure 23 and 24.
• Correct alignment of the tonometer (see Figure 25).
• Incorrect alignment of the tonometer (see Figure 26).
• Incorrect alignment of the tonometer. Readjust so that you see only
the front of the tonometer and the green light symmetrically in the
center of your view (see Figure 27).

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5. Press the measurement button:
Single mode:
Press the button briefly (1 second) and you hear a short beep, repeat
it to take one measurement at a time till you hear a long beep and
seetheDone light (17) illuminated on the back panel (Figure 5).
Series mode:
Keep the measurement button down to obtain the sequence of
six measurements till you hear a long beep and see the Done light
illuminated on the back panel. The button must be pressed for at
least3seconds (Figure 29).
6. If an error occurs, press the Measure button briefly (1 second) and
continue the measurement. See also section 13 Troubleshooting.
7. If both eyes are measured repeat above steps under 11.3 and 11.4
usingyour other eye.
8. Press the power button for three seconds to turn the tonometer off.
Theprobe slides out of the probe base. Note that the tonometer
willpower off automatically if unused for 3 minutes.
9. Remove and discard the used probe properly.
12. TRANSFERRING THE MEASUREMENT DATA
The tonometer stores information on every complete measurement sequence
of six measurements. The stored information includes the calculated
final eyepressure reading inmmHg, time and date of the measurement,
identification of the eye (right or left) and the quality level ofthe
measurement. Uploading is easy:
1. Start Icare software in your mobile device or PC (Figure 30).
2. Connect the tonometer to the mobile device or PC using the USB cable.
The Load and Measure lights will flash. If no lights flash or the SERVICE
and BATTERY lights flash, reconnect the USB cable.
3. The internal clock of the tonometer is automatically updated to the
mobile device's or PC's time by the Icare software at this point (Figure31).
More information about Icare software
http://www.icaretonometer.com
13. TROUBLESHOOTING
The tonometer automatically monitors and controls the measurement
position and speed of the probe during the measurements, and indicates
errors with sounds and lights. The following table instructs you in error
situations and explains what the different lights and sounds mean. All the
back panel indicator lights are presented in the list after the table.
Error light Error
sound
Reason Action
Battery
(Figure32)
No Battery is soon
empty.
Prepare to change batteries.
Battery light
isflashing
No Battery is
empty.
Change batteries.
Probe base
light is solid
red(Figure33)
No Too much
vertical tilt.
1. Press the measurement
button again to clear the error
message.
2. Position the tonometer
horizontally so that the probe
base light is green.

8Icare HOME Instruction Manual ENGLISH
Error light Error
sound
Reason Action
Probe base light
is flashing red
and Measure
light turns off
(Figure34)
Two long
beeps
Three
long
beeps
Five
short
beeps
Tonometer is
not correctly
aligned or
probe hit eyelid
or eyelash.
Tonometer is
too far from
eye.
Tonometer is
too close to
eye.
1. Press the measurement
button again to clear the error
message.
2. Set the probe perpendicular
to the center of the cornea.
3. Adjust the forehead/cheek
supports for correct distance.
4. Repeat measurement.
Repeat light is
flashing and
Probe base light
is flashing red
(Figure 35)
Two long
beeps
a) Too much
IOP deviation
during the
measurement,
because the
user did not
keep the
tonometer
stable.
b) Eye was not
recognized.
1. Press the measurement
button again to clear the error
message.
2. Repeat the measurement.
3. Do not move the tonometer
during the measurements,
remove your hand or fingers
from the infrared transmitters
and sensor, move the patient's
hair away from his/her temple
side of the eye.
Service light is
flashing and
Probe base is
flashing red
(Figure 36)
Two long
beeps
Damaged or
dirty probe or
probe base.
1. Change the probe and/or
probe base.
2. Contact provider of the
tonometer or a certified
service center.
The indicator lights on the back panel:
OFF (Figure 37)
1. Lights off
INTIALIZE (Figure 38)
2. LOAD (green icon)
3. MEASURE (green icon)
4. REPEAT (yellow icon)
5. DONE (green icon)
6. SERVICE (red icon)
7. BATTERY (red icon)
LOAD PROBE (Figure 39)
8. LOAD (green icon)
MEASURE (Figure 40)
9. MEASURE (green icon)
REPEAT (Figure 41)
10. REPEAT (yellow icon)
DONE (Figure 42)
11. DONE (green icon)
SERVICE (Figure 43)
12. SERVICE (red icon)
LOW BATTERY (Figure 44)
13. BATTERY (red icon)
EMPTY BATTERY (Figure 45)
14. BATTERY (red icon)
14. REPLACING THE PROBE BASE
Conditions during the use or transport of the tonometer can include lint,
dust, heat, moisture, hair, grease or other debris that can get to the probe
base andimpair the probe movement. To resolve these conditions replace
the probe base at least every 6 months. Change the probe, replace the probe
baseif the SERVICE light flashes.

9
www.icaretonometer.com
Instructions for replacing the probe base:
• Turn off 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
fingers 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
15. CLEANING AND DISINFECTION
The forehead and cheek supports must be cleaned for each new patient.
The health care professionals should use a wipe dampened with a 70-100%
isopropyl alcohol solution. The patients should use a cloth or paper towel
dampened with water. Do not immerse the tonometer in water or other liquid.
The tonometer must not be immersed or cleaned using too much water.
16. ACCESSORIES, DETACHABLE PARTS AND OTHER SUPPLIES
Part number Product Description Weight Dimensions
540 Probe base 4g 38mm × 7mm
TA022-118 TA022 narrow collar 2g 20mm × 13mm
560 Wrist strap 3g 270mm × 10mm × 10mm
TA022-044 Carrying case 210g 270mm × 135mm × 60mm
7179 Battery cover 3g 26mm × 23mm × 7mm
571 Battery 3 V, CR123A 17g 35mm × 17mm
TA022-037 Support position tags 40g 70mm × 41mm × 13mm
575 USB cable 23g 1m
113 Probe Icare TP022,
50pcs/box
55,14g 195 mm × 82 mm × 35 mm
17. LIFETIME
The expected service life of the device is 5 years. The maintenance described
in the chapters 12-15 is required during the the expected service life.
Theshelflife of the probes in their intact original packaging is 3 years.
Pleasecheck the shelf life (expiry date) from the probe label. We recommend
that you inspect the device for mechanical and functional damage and the
safety labels for legibility annually/every 12 months. The life time of the
batteries is about 5000 measurements.
Applicable in Germany only: Messtechnische Kontrolle nach MPG
(Medizinproduktegesetz) alle 24 Monate.
18. TECHNICAL AND PERFORMANCE DATA
Type: TA022
Dimensions: approximately 11cm x 8cm x 3cm
Weight: approximately 150g
Power supply: 2 x CR123 non-rechargeable batteries (make sure you use
batteries with built-in PTC protection, for example Energizer Lithium Photo
123 3V CR123A)
Measurement range: 5-50mmHg
Accuracy (95% tolerance interval relatively to manometry): ±1,2mmHg
(≤20mmHg) and ±2.2mmHg (>20mmHg)
Repeatability (coefficient of variation): <8%
The serial number is located on the inside of the battery compartment cover.
The lot number of the probes is on the side of the probe box and the blister
packing.
There are no electrical connections from the tonometer to the patient. Allthe
parts of the tonometer are applied parts and the tonometer has BF-type
electric shock protection.

10 Icare HOME Instruction Manual ENGLISH
Environmental restrictions for professional use include:
• Medivac vehicles or similar where vibration or noise levels are so high
thatthe user cannot hear error signals.
Environmental restrictions for lay operators (patients):
• Environments where noise is so high that the user cannot hear the
errorsignals.
Mode of operation: continuous
19. SYMBOLS
Caution
See operating instructions for
more information
BF-type device
Single-use disposable
SN Serial number
Use by <date>
Manufacturer
IP22
Protected against insertion of fingers
and will not be damaged or become
unsafe during a specified test in
which it is exposed to vertically or
nearly vertically dripping water.
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
It is recommended to cool the tonometer for an hour from the maximum
storage temperature or to warm the tonometer for an hour from the
minimum storage temperature before use.
Transport environment:
Temperature: -40°C to +70°C
Relative humidity: 10% to 95%
Atmospheric pressure: 500hPa- 1060hPa
Class 1 LED product
This product meets the power
requirements for a Class 1 LED
product to IEC/EN 60825-1 (2001)
under normal operating conditions
and those of single fault failure.
Keep dry
Manufacturing date
LOT Lot number
STERILE R Sterilized using irradiation
Stand by
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)
Storage environment
Transport environment
Temperature
limits
Humidity
limits
Atmospheric
pressure limits

11
www.icaretonometer.com
20. ELECTROMAGNETIC DECLARATION
Icare HOME is class B equipment and needs special precautions regarding
EMC and needs to be installed and put into service according to EMC
information provided below.
Guidance and manufacturer's declaration–Electromagnetic emissions
Icare HOME (TA022) is intended for use and should be used in the
electromagnetic environment specified below.
RF emissions CISPR 11 Group 1 Icare HOME (TA022) is battery
operated and uses 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 HOME (TA022) 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
Power level of Icare HOME (TA022)
is below standard requirement,
batteries are not rechargeable.
Voltage fluctuations
flickering emissions
IEC 61000-3-3
NOT
APPLICABLE
Icare HOME (TA022) batteries are
not rechargeable.
Guidance and manufacturer's declaration–Electromagnetic immunity
Icare HOME (TA022) is intended for use and should be used in the
electromagnetic environment specified below.
Immunity test IEC 60601
Testlevel
Compliance
level
Electromagnetic
environment-
Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8kV contact
±2kV, ±4kV, ±8kV,
±15kV air
±8kV contact
±15kV air Floors should be wood, concrete or ceramic
tile. If floors are
covered with synthetic
material, the relative
humidity should be at
least 30%.
Electrical fast
Transients/burst
IEC 61000-4-4
±2kV 100kHz
repetition
frequency
NOT
APPLICABLE Icare HOME (TA022) tonometer is not
operational when
connected to an
external computer,
Icare HOME (TA022)
batteries are not
rechargeable.
Surge
IEC 61000-4-5 ±1kV for line(s) toline(s)
±2kV for line(s)
toearth
NOT
APPLICABLE Icare HOME (TA022) tonometer is not
operational when
connected to an
external computer,
Icare HOME (TA022)
batteries are not
rechargeable.
Voltage dips,
short interruption
and voltage
variations on
power supply
lines
IEC 61000-4-11
0% UT for 0.5cycle
(1phase)
0% UT for 1 cycle
70% UT for 25/30
cycles (50/60Hz)
0% UT for 250/300
cycles (50/60Hz)
NOT
APPLICABLE
Icare HOME (TA022)
tonometer is not
operational when
connected to an
external computer,
Icare HOME (TA022)
batteries are not
rechargeable.

12 Icare HOME Instruction Manual ENGLISH
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
30A/m 30A/m Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment.
WARNING: Sources
of power frequency
magnetic field should
be used no closer than
15cm (6 inches) to any
part of Icare HOME
(TA022), including
cables specified by
the manufacturer.
Otherwise, degradation
of the performance
could result.
The measurement
method of the Icare
HOME tonometer is
based on magnetic
induction and therefore
an external magnetic
field in line with the
probe may prevent the
measurement.
In such case the
tonometer will
continuously ask
to repeat the
measurement.
Situation can be solved
either by removing the
source of interference
from the vicinity of the
device or by performing
the measurement in
different location with
no such interference.

13
www.icaretonometer.com
Guidance and manufacturer's declaration– Electromagnetic immunity
Icare HOME (TA022) is intended for use and should be used in the
electromagnetic environment specified below.
Immunity test IEC 60601
Test level
Compliance
level
Electromagnetic
environment-
Guidance
Conducted RF
IEC 61000-4-6
3 V
0,15MHz- 80MHz
3 V WARNING:
Portable RF
communications
equipment (including
peripherals such as
antenna cables and
external antennas)
should be used no
closer than 30cm
(12inches) to any
partof the Icare HOME
(TA022), including
cables specified by
the manufacturer.
Otherwise, degradation
of the performance of
this equipment could
result.
6 V in ISM and
amateur radio bands
between 0,15MHz
and 80MHz 80%
AM at 1kHz
6 V
Radiated RF
IEC61000-4-3
10V/m 80MHz-
2,7GHz 80% AM at
1kHz
10V/m
Proximity fields
from RF wireless
communications
equipment
IEC61000-4-3
380-390MHz
27V/m; PM 50%;
18Hz
27V/m
430-470MHz 28V/m;
(FM ±5kHz, 1kHz
sine) PM; 18Hz
28V/m
704-787MHz 9V/m;
PM 50%; 217Hz
9V/m
800-960MHz
28V/m; PM 50%;
18Hz
28V/m
1700-1990MHz
28V/m; PM 50%;
217Hz
28V/m Interference may
occur in the vicinity of
equipment marked
with the following
symbol:
2400-2570MHz
28V/m; PM 50%;
217Hz
28V/m
5100-5800MHz
9V/m; PM 50%;
217Hz
9V/m
21. TRAINING
All health care professionals, patients and caregivers should practice the
use of the tonometer with this instruction manual or the patient guide and
a training video, or receive training from a trained professional prior to
performing tonometry.

Icare HOME GEBRAUCHSANWEISUNG DEUTSCH
DEUTSCH
1. Sicherheitsvorschriften................................................................................. 15
2. Glossar............................................................................................................ 17
3. Verwendungszweck ...................................................................................... 17
4. Funktionsweise des Tonometers ................................................................ 17
5. Kontraindikationen ....................................................................................... 18
6. Risiken ............................................................................................................ 18
7. Nutzen ............................................................................................................ 18
8. Lieferumfang ................................................................................................. 19
9. Vor dem Beginn............................................................................................. 19
10. Einrichten des Tonometers.......................................................................... 19
10.1 Einsetzen oder Auswechseln der Batterie ....................................... 19
10.2 Einschalten des Tonometers ............................................................ 19
10.3 Einsetzen des Messgebers................................................................. 20
11. Nutzung des Tonometers............................................................................. 20
11.1 Auswahl des Messmodus................................................................... 20
11.2 Automatische Augenerkennung........................................................ 20
11.3 Einstellen der messposition............................................................... 20
11.4 Durchführung der Messung: ............................................................. 21
12. Übertragung der Messdaten ....................................................................... 21
13. Fehlersuche.................................................................................................... 22
14. Austausch des Messgebereinsatzes ........................................................... 23
15. Reinigung und Desinfektion......................................................................... 23
16. Zubehör, abnehmbare teile und sonstige betriebsstoffe........................ 23
17. Laufzeit ........................................................................................................... 24
18. Technische und Leistungsdaten.................................................................. 24
19. Symbole.......................................................................................................... 25
20. Elektromagnetische Angaben...................................................................... 25
21. Schulung......................................................................................................... 27

15
www.icaretonometer.com
Icare Finland Oy
Äyritie 22, 01510 Vantaa
Tel. +358987751150, Fax +35897286670
www.icaretonometer.com, info@icarenland.com
1. SICHERHEITSVORSCHRIFTEN
WARNUNG!
Drücken Sie das Tonometer nicht in das Auge (der Messkopf sollte 4-8 mm
oder 5/32-5/16“ vom Auge entfernt sein). Verwenden Sie keinesfalls einen
Messkopf ohne Kunststospitze.
WARNUNG!
Bewahren Sie das Tonometer außerhalb der Reichweite von Kindern und Tie-
ren auf, da der Messgebereinsatz, der Batteriefachdeckel und die Messgeber
so klein sind, dass ein Kind sie verschlucken könnte.
WARNUNG!
Die Messgeber sollen nur ein Mal verwendet werden und sind steril verpackt.
WARNUNG!
Berühren Sie den ungeschützten Messgeber nicht und verwenden Sie keine
Messgeber, die in Kontakt mit einer nicht sterilen Oberäche wie einem Tisch
oder dem Boden gekommen sind, um eine Kontamination zu vermeiden.
WARNUNG!
Medizinische Fachkräfte müssen ihre Patienten darüber informieren, dass die
Behandlung nicht ohne ärztliche Beratung abgebrochen oder verändert wer-
den darf.
WARNUNG!
Nutzen Sie den USB-Anschluss aus Gründen der Cybersicherheit nur zum
Hochladen von Patientenmessdaten. Das Tonometer wird es Ihnen auch nicht
erlauben, Messungen vorzunehmen, während das USB-Kabel angeschlossen
ist. Alle anderen traditionellen Cybersicherheit-Kontrollen (Antivirus-Software,
Malware-Software, getrenntes Netzwerk für das Gerät usw.) gelten nicht, da es
sich um ein Einzelgerät handelt, welches nicht vernetzt ist und keine Betriebs-
systemsoftware enthält.
WARNUNG!
Solange das USB-Kabel angeschlossen ist, dürfen weder die Batterien noch
der Messgebereinsatz ausgetauscht werden.
WARNUNG!
An dem Gerät dürfen keinerlei Modikationen vorgenommen werden.
WARNUNG!
Verwenden Sie nur die vom Hersteller produzierten und zertizierten Ori-
ginal-Messgeber. Die Messgeber dürfen nur einmal (für ein einzelnes Paar
Messsequenzen) verwendet werden. Verwenden Sie nur Messgeber aus un-
versehrten Originalverpackungen. Bei Beschädigung der Verpackung kann die
Sterilität des Messgebers nicht gewährleistet werden. Erneute Sterilisierung
oder Wiederverwendung des Messgebers kann zu falschen Messergebnissen,
Defekt des Messgebers, Kreuzkontamination durch Bakterien oder Viren und
DEUTSCH
Icare® HOME (Modell: TA022) GEBRAUCHSANWEISUNG
Die in diesem Dokument enthaltenen Informationen können ohne Vorankün-
digung geändert werden.
Bei Widersprüchen zwischen den Sprachversionen ist die englische Fassung
maßgeblich.
Dieses Gerät entspricht: Richtlinie 93/42/EWG für medizinische Geräte
Canadian Medical Device Regulations
RoHS-Richtlinie 2011/65/EU
Copyright © 2020 Icare Finland Oy
Hergestellt in Finnland
0598

16 Icare HOME GEBRAUCHSANWEISUNG DEUTSCH
zu einer Infektion des Auges führen. Bei erneuter Sterilisierung oder Wieder-
verwendung verfällt die Verantwortung und Haftung des Herstellers bezüglich
der Sicherheit und Wirksamkeit des Tonometers.
WARNUNG!
Die Verwendung von Zubehör, Signalgebern und Kabeln, die nicht speziziert
oder vom Hersteller dieses Geräts zur Verfügung gestellt wurden, könnte zu
erhöhter elektromagnetischer Strahlung oder zu verminderter elektromagne-
tischer Immunität dieses Geräts und zu unsachgemäßer Bedienung führen.
WARNUNG!
Tauchen Sie das Icare Tonometer niemals in Flüssigkeit. Lassen Sie keine Flüs-
sigkeiten an das Icare Tonometer, seine Zubehörteile, Anschlüsse, Schalter
oder Gehäuseönungen gelangen. Wischen Sie eventuelle Spritzer auf der
Oberäche des Tonometers sofort ab.
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 Kali-
brierungsmaßnahmen außer dem Batteriewechsel mindestens alle 12 Monate
und dem Auswechseln des Messgebereinsatze alle 6 Monate. Sollten ander-
weitige Wartungsmaßnahmen erforderlich sein, wenden Sie sich bitte an den
Kundendienst von Icare Finland oder an Ihren örtlichen Fachhändler.
WARNUNG!
Im Fall eines Batteriekurzschluss könnten die Batterien und das Gerät heiß
werden. Bei Berührung besteht dann eine mögliche Verbrennungsgefahr.
DasGerät kann in diesem Fall eine Temperatur bis zu 60°C und die Batterien
bis zu 90°C erreichen, weshalb das Gerät nicht verwendet werden sollte.
WARNUNG!
Achten Sie beim Ablesen der Messdaten in Kliniken oder Krankenhäusern
darauf, dass sich Tonometer und PC/Mobilgerät in einem Abstand von min-
destens 1,5m zum Patienten benden.
WARNUNG!
Verwenden Sie das Tonometer nicht in eingeschränkten Umgebungen wie in
Kapitel 18 dieser Anleitung beschrieben.
WARNUNG!
Schließen Sie ausschließlich nur das mit dem Tonometer mitgelieferte USB-
Kabel an den USB-Anschluss an.
WARNUNG!
Um bei Bedarf Unterstützung bei der Einstellung, Verwendung oder Wartung
des Tonometers zu erhalten oder um unerwünschte Betriebsverläufe oder
Zwischenfälle zu melden, wenden Sie sich bitte an den Hersteller oder dessen
Vertreter.
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 ande-
re Geräte zu beobachten, um deren normalen Betrieb zu überprüfen.
WARNUNG!
Magnetfeldquellen mit Netzfrequenz dürfen nicht näher als 15cm (6 Zoll) an
irgendeinem Teil des Icare HOME (TA022) verwendet werden, einschließlich
der vom Hersteller spezizierten Kabel. Andernfalls droht ein Leistungsabfall.
VORSICHT!
• Kontrollieren Sie das Gerät nach dem Önen der Verkaufspackung auf
sichtbare Schäden, insbesondere am Transportkoer. Wenden Sie sich bei
Verdacht auf Fehler am Tonometer an den Händler, der Ihnen das Tono-
meter verkauft hat.
• Verwenden Sie das Tonometer ausschließlich zur Messung des intraokula-
ren Drucks. Jegliche anderweitige Verwendung ist zweckwidrig. Der Herstel-
ler haftet nicht für Schäden, die aus dem unsachgemäßen Gebrauch des
Geräts resultieren, noch für die Folgen einer derartigen Nutzung.