icare HOME TA022 User manual

1www.icaretonometer.com
TA022-035-USA-1.4
Belongs to:
PATIENT
GUIDE
ENGLISH

Icare HOME Patient Guide ENGLISH
Icare HOME Patient Guide ENGLISH
Icare HOME (Model: TA022) PATIENT
GUIDE TA022-035
TABLE OF CONTENTS
Safety instrucons................................................ 3
Glossary................................................................
Introducon..........................................................
How does the tonometer work ............................
Contraindicaons .................................................
Risks .....................................................................
Benefits ................................................................
Tonometer overview ............................................
Preparing the tonometer for use .........................
Posioning the tonometer ...................................
Compleng the measurement .............................
Troubleshoong ..................................................
Replacing the baeries ........................................
..................................... 20
..................
........................... ......
............................................................. .
SAFETY INSTRUCTIONS
WARNING!
WARNING!
WARNING!
WARNING!
WARNING!
WARNING!
WARNING!
WARNING!
D
WARNING!
WARNING!
WARNING!
Icare Finland Oy Äyritie
22, 01510 Vantaa
Copyright © 2019 Icare Finland Oy
Made in Finland
0598
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.................................................... 31
SAFETY INSTRUCTIONS
WARNING!
You should not use the device in areas with a high noise level where
sound error codes cannot be heard.
WARNING!
Do not push the tonometer into the eye (never use a probe that has
no plasc p).
WARNING!
Keep the tonometer out of the reach of children and pets, because
the probe base, baery compartment cover and probes are so small
that a child or pet could swallow them.
WARNING!
The probes are for single-use only, and are packaged sterile.
WARNING!
To prevent contaminaon, do not touch the bare probe, do not use
a probe if it touches a non-sterile surface like a table or a oor.
WARNING!
Do not to modify or disconnue your treatment plan without
receiving instrucons from the health care professional.
WARNING!
For cybersecurity do not connect anything to the USB port except
when uploading paent measurement data. All other tradional
cybersecurity controls (an-virus soware, malware soware,
separate network for the device, etc.) do not apply since the device
is stand alone, is not networked, and does not contain operang
system soware.
WARNING!
Do not change the baeries or probe base when the USB cable is
connected.
WARNING!
Do not connect the USB cable during measurement, the tonometer
will not allow you to take measurements while the USB cable is
connected.
WARNING!
No modicaon of this equipment is allowed.
WARNING!
Use only the original and cered 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-sterilizaon
or re-use of the probe could result in incorrect measurement values,
in the breakdown of the probe, cross-contaminaon of bacteria or
viruses, and infecon of the eye. Re-sterilizaon or re-use will void
all resposibilies and liabilies of the manufacturer concerning the
safety and eecveness of the tonometer.
Icare HOME (Model: TA022) PATIENT
GUIDE TA022-035-EN-4.0
This device complies with:
Medical Device Directive 93/42/EEC
Canadian Medical Device Regulations
RoHS Directive 2011/65/EU
Copyright © 2019 Icare Finland Oy
Made in Finland
Icare Finland Oy Äyritie
22, 01510 Vantaa
Finland
TABLE OF CONTENTS
Safety Instrucons....................................................3
Glossary....................................................................7
Introducon..............................................................7
How does the tonometer work ................................7
Contraindicaons .....................................................8
Risks..........................................................................9
Benets ....................................................................9
Tonometer overview ..............................................10
Preparing the tonometer for use............................12
Posioning the tonometer .....................................14
Compleng the measurement ...............................16
Troubleshoong .....................................................18
Replacing the baeries...........................................20
Replacing the probe base .......................................20
Cleaning the tonometer .........................................22
Transferring the measurement data.......................22
Clinical performance data ......................................24
Lifeme...................................................................25
Technical data.........................................................25
Symbols ..................................................................26
Electromagnec declaraon...................................28
Geng support ......................................................31

Icare HOME Patient Guide ENGLISH
5www.icaretonometer.com4
WARNING!
Use of accessories, transducers and cables other than those
specied or provided by the manufacturer of this equipment
could result in increased electromagnec emissions or
decreased electromagnec immunity of this equipment and
result in improper operaon.
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 Icare HOME tonometer is indicated for use only under
supervision of a health care professional.
WARNING!
The tonometer should only be opened by qualied service
personnel. It contains no user-serviceable parts, apart from the
baeries and the probe base. The Icare tonometer requires
no roune servicing or calibraon other than changing the
baeries at least every 12 months and the probe base every
6 months. If there is reason to believe servicing of the device is
necessary, contact qualied service personnel or your local Icare
representave.
WARNING!
In the event of baery short circuit, the baeries 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 the baeries 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 paent.
WARNING!
Do not use the tonometer in the restricted environments
dened in the Technical data secon 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 seng up, using or maintaining the
tonometer or to report unexpected operaon or events, contact
the manufacturer or the manufacturer’s representave.
WARNING!
Use of this equipment adjacent to or stacked with other
equipment should be avoided because it could result in
improper operaon. If such use is necessary, this equipment
and the other equipment should be observed to verify that they
are operang normally.
WARNING!
Sources of power frequency magnec eld should be used no
closer than 15 cm (6 inches) to any part of Icare HOME (TA022),
including cables specied by the manufacturer. Otherwise,
degradaon of the performance could result.
WARNING!
The probe should be replaced if it contacts or is suspected of
having contacted the eyelashes or eyelid such as might occur
during a blink.
PRECAUTION!
• When you have opened the package, check for any external
damage or faults, parcularly 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
baery compartment.
• Never allow the tonometer to get wet.
• Do not use the tonometer near ammable substances,
including ammable anesthec agents.
• Certain microbiological agents (for example, bacteria) can be
transmied from the forehead or cheek support. The health
care professionals should use a wipe dampened with a 70-
100% isopropyl alcohol soluon. The paents should use a
cloth or paper towel dampened with water.
• The tonometer conforms to EMC requirements (IEC 60601-1-
2), but interference may occur within the tonometer if used
near (<1m) a device causing high intensity electromagnec
emissions, such as a cellular phone. Although the
tonometer’s own electromagnec emissions are well below
the levels permied by the relevant standards, they may
cause interference in other, nearby devices, for example
sensive sensors.

Icare HOME Patient Guide ENGLISH
7www.icaretonometer.com6
PRECAUTION!
• If you do not use the tonometer for a long me, remove the
baeries, as they may leak.
• Be sure to dispose of the single-use probes properly (for
example, in a mixed waste bin).
• Baeries, packaging materials and probe bases must be
disposed of according to local regulaons.
• Make sure you use baeries with built-in PTC protecon, for
example Energizer Lithium Photo 123 3V CR123A.
• Do not cover the eye recognion transmiers or sensor
during the measurement, for example with your ngers. Keep
your hand, hair etc. and objects such as pillows away from
the temple side of your eye, as they produce an infrared
reecon that causes an error.
• The tonometer turns o automacally aer 3 minutes if you
do not use it.
• Update the tonometer’s me to your local me. It is done
automacally by performing the steps under secon
Transferring 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 magnec inducon and therefore an external
magnec eld in line with the probe may prevent the
measurement. In such case the tonometer will connuously
ask to repeat the measurement. Situaon can be solved
either by removing the source of interference from the
vicinity of the device or by performing the measurement in
dierent locaon with no such interference.
Safety incidents: For reporng a serious incident with the
Icare HOME tonometer or soware used with it, contact Icare
technical service at www.icaretonometer.com
GLOSSARY
Goldmann Applanaon Tonometry = the standard eye test that
can detect your eye pressure (IOP)
Tonometer = a device for measuring your IOP
mmHg = units of measurement for the pressure in your eye
Probe = tonometer’s single-use item that lightly touches your eye
Probe base light = light ring that assists you to posion the probe
Shelf life = the me 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 me before replacement
Electromagnec immunity = tonometer’s ability to withstand
disturbances from other electrical equipment
INTRODUCTION
This guide will teach you how to use the Icare HOME
tonometer.
The Icare HOME tonometer is a device intended
for monitoring of intraocular pressure (IOP) of the
human eye. It is indicated for use by paents or
their caregivers under supervision of an eye care
professional.
HOW DOES THE TONOMETER
WORK
The tonometer measures your eye pressure using
a disposable probe that gently contacts your eye
during the measurement. The recommended
frequency of measurements is 3-4 mes 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. Aer the series of six measurements,
the tonometer calculates your nal eye pressure and
stores it in the tonometer’s memory.

Icare HOME Patient Guide ENGLISH
9www.icaretonometer.com8
BENEFITS
You can take measurements of your eye pressure
at various mes during the day and night with
the Icare HOME tonometer. Measurements taken
outside your oce visits may help your doctor
beer understand your eye pressure, especially if
you already have a glaucoma diagnosis.
RISKS
You may not be eligible for use of the HOME
tonometer if you:
• Have poor uncorrected near vision
• Have only one working eye
• Have poor or o-center visual xaon
• Have poor hearing without an aid and/or
communicate using sign language
• Use contact lens
• Have dry eyes
• Have Keratoconus (a corneal disorder)
• Have a congenitally (from birth) small eye
• Have an enlarged eye from childhood glaucoma
• Had a cataract removed within last 2 months
The safety and eecveness of the Icare HOME
tonometer has not been evaluated for paents
with:
• High corneal asgmasm
• History of prior invasive glaucoma surgery or
corneal surgery including corneal laser surgery
(for example, LASIK)
• Corneal scarring
• Very thick or very thin corneas
• Paents for whom there is already diculty
inobtaining clinical IOP measurements (for
example, due to eyelid squeezing or tremor)
CONTRAINDICATIONS
You should not use the HOME tonometer if you:
• Have an acve ocular infecon (for example, pink
eye)
• Had recent trauma to your eye
• Have disabling arthris or diculty handling the
Icare tonometer
• Have a severe diculty in opening your eyes
including abnormal contracons or twitches of
the eyelid
• Have involuntary, rapid and repeve movement
of the eyes
The probe is disposable. You can use the same
probe for both eyes if the health care professional
instructed you to measure both eyes. Aer you
have taken the measurements for both eyes,
dispose the probe in a mixed waste bin.
The tonometer includes infra-red eye recognion
sensors to idenfy which eye, right or le, you
are measuring. It is important not to cover these
sensors with your ngers, 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 reecon that causes an error.
It is important that you carefully read all
instrucons before using the tonometer.

Icare HOME Patient Guide ENGLISH
11www.icaretonometer.com10
TONOMETER OVERVIEW
Cheek support
adjustment wheel
FRONT
BACK BOTTOM
Measure buon
LOAD indicator
MEASURE indicator
REPEAT indicator
DONE indicator
SERVICE indicator
BATTERY indicator
Power buon
Cheek support posion
indicator
Type label
Cheek support
adjustment wheel
Silicone lid (USB cover)
Baery cover
Forehead support adjustment wheel
Forehead support
Eye recognion sensors (Detect which
eye is measured)
Probe base (with indicator light)
Probe
Cheek support

Icare HOME Patient Guide ENGLISH
13www.icaretonometer.com12
Make sure the forehead and cheek support
posions match the posions your eye care
professional wrote on the support poson tag
for you.
The support posion tag is found in the carrying
case. If needed, turn the support wheels to set
supports to correct sengs.
Press and hold down the Power buon
for 3 seconds. All the indicator lights on the
back panel will ash once and you will hear a
short beep.
The LOAD indicator will connue to ash
indicang that the tonomoter is ready to load
the probe.
Gather new probe and unwrap package.
WARNING
• Use only original and cered probes made
by the manufacturer.
• Do not touch the probe.
• The shelf life of the probes is 3 years.
• Use a new, unused probe aer measurements
for both eyes have been taken.
• You should thoroughly wash your hands with
soap and water and dry them with a clean
towel prior to handling the probe.
Hold the probe container upright, with the
container cap on top. Uncap the container,
lt the container to allow the probe to drop
into the probe base, then press the Measure
buon .
LOAD light ashes unl probe is loaded.
MEASURE light starts ashing when tonometer
is ready to measure. Keep the probe container
as the probe will be disposed of in it.
WARNING
• Do not touch the probe.
• Do not point the tonometer down.
• Do not use the probe if it touches a non-
sterile surface like table or oor.
PREPARING THE TONOMETER
FOR USE
1
2
3
4

Icare HOME Patient Guide ENGLISH
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Red indicator lightGreen indicator light
Hold the tonometer in front of your eye with the
forehead and cheek supports against your face.
Make sure that the probe base light is visible.
WARNING
Make sure that the probe or any part of the
tonometer does not contact your eyes.
Make sure the probe base light is green.
If the probe base light is red, make sure you are
facing straight ahead (i.e., head held at a 90° angle)
and lt the tonometer unl the probe base light
turns green.
PRECAUTION
Do not cover the eye recognion sensors,because
covering the sensors causes an error.
Make sure you see the probe base light ring
symmetrically to ensure the probe contacts the
center of the cornea during measurement.
Correct
posion
Slightly lted
horizontally
Slightly lted
vercally
POSITIONING THE TONOMETER
5
6
7
i

Icare HOME Patient Guide ENGLISH
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Press the Measure buon to measure
pressure (probe will contact eye during
measurements).
Press and hold down the Measure buon unl
you hear a beep to collect 6 measurements
in a row, or press the buon briey 6 mes to
collect one measurement at a me.
PRECAUTION
If an error occurs (two, three or ve beeps and
the probe base light is ashing red), follow the
instrucons in chapter Troubleshoong.
When the measurement ends successfully, you
will hear a long beep, the probe base light will
power o, and the Done light illuminates.
If your doctor instructed you to measure both
eyes, repeat steps 1 through 9 for your other
eye. The probes are single use. Use a new,
unused probe when you do measurements the
next me.
WARNING
You should replace the probe if it comes into
contact with your eyelashes or eyelid or you
suspect it did.
Aer compleng all measurements, power
o the tonometer by pressing and holding the
Power buon down for 3 seconds unl
you hear 3 beeps.
You can remove the probe aer measuring the
eye pressure. Power o the tonometer and
allow the probe to slide out. Place the probe
back in its container and dispose of it in a
mixed waste bin.
PRECAUTION
The tonometer will power o automacally if
unused for 3 minutes.
COMPLETING THE
MEASUREMENT
8
9
10
i
i
Steps 1-10

Icare HOME Patient Guide ENGLISH
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Probe base indicator light is
solid red.
Cause: Tonometer is not held
straight.
Probe base indicator light is
ashing red and you hear:
2 beeps - Tonometer is not
correctly aligned or probe hit
eyelid or eyelash.
3 slow beeps - Tonometer is
too far from the eye.
5 fast beeps - Tonometer is too
close to eye or probe hit eyelid
or eyelash.
Probe base indicator light is
ashing red and REPEAT light
on the back panel is ashing
and you hear 2 beeps.
Cause: Eye recognion failed
or too much variaon between
measurements.
Probe base indicator light is
ashing red and SERVICE light
is ashing and you hear 2
beeps.
Cause: The probe or probe
base is dirty or damaged.
BATTERY light is ashing.
Cause: Baery power is low.
ERROR MESSAGE
TROUBLESHOOTING
1. Make sure you are facing straightahead (i.e.,
head held at a 90° angle).
2. Adjust the tonometer’s lt angle unl probe
base light turns green.
1. Press the Measure buon to clear error.
2. Adjust the forehead/cheek supports for correct
distance if needed.
3. Set the probe perpendicular to the center of the
cornea.
4. Repeat measurement.
1. Press the Measure buon to clear error.
2. Make sure to complete a reading for one eye
before switching to other eye.
3. Make sure the eye recognion sensors ortemple
side of the eye are not covered as covering them
causes the eye recognion to fail and the error.
4. Repeat measurement.
1. Change the probe and/or probe base.
2. Contact provider of the tonometer or a cered
service center.
Change the baery.
See pages 20-21 for instrucons.
SOLUTION

Icare HOME Patient Guide ENGLISH
21www.icaretonometer.com20
i
i
i
Li silicone lid from baery cover then slide
baery cover open.
Remove used baeries and insert 2 new
CR123A lithium baeries.
Make sure the baeries’ posive end (+) is
facing the baery cover.
Slide the baery cover back over the baery
opening and insert the silicone lid back into
the USB port.
Turn power o from the tonometer. By hand,
unscrew the probe base collar and place it in
a safe locaon. Pull the probe base out of the
tonometer using thumb and ngers. Insert a
new probe base into the tonometer. Screw the
collar in unl it locks the probe base.
REPLACING THE BATTERIES
REPLACING THE PROBE BASE
1
1
2
3
Silicone lid
USB port
Adjustment wheel
PRECAUTION
Do not use rechargeble baeries.
PRECAUTION
Change the probe base every six months.
PRECAUTION
Do not screw the collar in too ghtly to
prevent the collar from breaking.
Icare HOME Patient Guide ENGLISH 21
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20
Make sure the baeries’ posive end
(+) is facing the baery cover.
opening and insert the silicone lid back into
the USB port.
REPLACING THE BATTERIES
1
2
3
Silicone lid
USB port
Adjustment wheel
1
REPLACING THE PROBE BASE
i
Turn power off from the tonometer. By hand,
unscrew the probe base collar and place it in a
safe locaon. Pull the probe base out of the
tonometer using thumb and fingers. Insert a
new probe base into the tonometer. Screw the
collar in unl it locks the probe base.
PRECAUTION
in
PRECAUTION
Change the probe base every six months.
PRECAUTION
Do not use rechargeable baeries.
Probe base collar
Probe base

Icare HOME Patient Guide ENGLISH
23www.icaretonometer.com22
Connected
Slightly dampen a cloth or paper towel with
water.
Make sure to remove excess water from the
cloth or paper towel.
Clean the tonometer with the damp cloth or
paper towel.
WARNING
Do not immerse the tonometer in water or any
other liquid.
Start Icare soware in your mobile device
or PC. Connect the tonometer to the mobile
device or PC using the USB cable. The LOAD
and MEASURE lights will ash. If no lights
ash or the SERVICE and BATTERY lights ash,
reconnect the USB cable. The internal clock
of the tonometer is automacally updated to
the mobile device’s or PC’s me by the Icare
soware at this point.
CLEANING THE TONOMETER
TRANSFERRING THE
MEASUREMENT DATA
1
1
2

Icare HOME Patient Guide ENGLISH
25www.icaretonometer.com24
CLINICAL PERFORMANCE DATA
• No complicaons (including corneal abrasions)
were recorded.
• The eye pressure ranges measured were ≤16
mmHg, >16 to <23 mmHg and ≥23 mmHg (mmHg
is the unit of measure for eye pressure).
• The average dierence of Icare HOME versus
the gold standard measurement method
(Goldmann measurement device that is used in
eye clinics) was approximately 0.5 mmHg (the
average pressure measurement in the study was
approximately 18 mmHg with a range of 5 to 50
mmHg).
• Compared to the Goldmann tonometer, less than
5% of measurements fell outside ± 5 mmHg at
each pressure range and less than 1% fell outside
± 7.5 mmHg at each pressure range.
• The Icare HOME’s variability (dierence of repeat
measurements) on the same eye was ~10% for
the low and medium pressure range and ~7.5%
for the high pressure range.
• Only cered users were able to proceed to
self-tesng. 10.7% of the paents failed to pass
training/cercaon.
• In this study, self-tesng was limited to a single
session 10 minutes aer cercaon.
A study was conducted with 383 paents
performing self-measurements with the
Icare HOME tonometer. A summary of the
study ndings are below:
LIFETIME
The expected service life of the device is 5 years.
Following the instrucons described in this
manual 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 (expiraon date) from the probe label.
We recommend that you inspect the device for
mechanical and funconal damage and the safety
labels for legibility annually/every 12 months.
The life me of the baeries is about 5000
measurements.
TECHNICAL DATA
Type: TA022
Dimensions: approximately 11cm x 8cm x 3cm
Weight: approximately 150g
Power supply: 2 x CR123 non-rechargeable baeries
(make sure you use baeries with built-in PTC
protecon, Energizer, Varta, Panasonic or Toshiba
Lithium 3V CR123A)
Measurement range: 5-50 mmHg
Accuracy (95% tolerance interval relavely to
manometry): ±1,2mmHg (≤20 mmHg) and ±2.2
mmHg (>20 mmHg)
Repeatability (coecient of variaon): < 8%
The serial number is located on the inside of the
baery compartment cover. The lot number of the
probes is on the side of the probe box and the blister
packing. There are no electrical connecons from
the tonometer to the paent. All the parts of the
tonometer are applied parts and the tonometer has
BF-type electric shock protecon.

Icare HOME Patient Guide ENGLISH
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Operaon environment:
Temperature: +10 °C to +35 °C
Relave humidity: 30% to 90%
Atmospheric pressure: 800hPa – 1060hPa
Storage environment:
Temperature: -10 °C to +55 °C
Relave humidity: 10% to 95%
Atmospheric pressure: 700hPa – 1060hPa
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
Relave humidity: 10% to 95%
Atmospheric pressure: 500hPa – 1060hPa
Environmental restricons for professional use
include:
• Medivac vehicles or similar where vibraon or
noise levels are so high that the user cannot hear
error signals.
Environmental restricons for lay operators
(paents):
• Environments where noise is so high that the user
cannot hear the error signals.
Mode of operaon: connuous
SYMBOLS
Cauon
See operang
instrucons for
more informaon
BF-type device
Single-use disposable
Keep dry
SN Serial number
Use by <date>
Manufacturer
Stand by
IP22
Protected against inseron
of ngers and will not be
damaged or become unsafe
during a specied test
in which it is exposed to
vercally or nearly vercally
dripping water.
Class 1 LED product
This product meets the
power requirements for a
Class 1 LED product to IEC/
EN 60825-1 (2001) under
normal operang condions
and those of single fault
failure.
Manufacturing date
LOT Lot number
Do not discard
this product with
other household-
type waste. Send to
appropriate facility for
recovery and recycling.
EU WEEE (European
Union Direcve for
Waste of Electronic
and Electrical
Equipment)
STERILE R Sterilized using irradiaon
Storage
environment
Transport
environment
Temperature
limits
Humidity
limits
Atmospheric
pressure limits

Icare HOME Patient Guide ENGLISH
29www.icaretonometer.com28
ELECTROMAGNETIC DECLARATION
WARNING!
Use of accessories, transducers and cables other than those
specied or provided by the manufacturer of this equipment
could result in increased electromagnec emissions or decreased
electromagnec immunity of this equipment and result in
improper operaon.
WARNING!
Use of this equipment adjacent to or stacked with other
equipment should be avoided because it could result in improper
operaon. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operang
normally.
PRECAUTION!
The measurement method of the Icare HOME tonometer is based
on magnec inducon and therefore an external magnec eld in
line with the probe may prevent the measurement. In such case
the tonometer will connuously ask to repeat the measurement.
Situaon can be solved either by removing the source of
interference from the vicinity of the device or by performing the
measurement in dierent locaon with no such interference. Icare
HOME (TA022) tonometer is a class B equipment and needs special
precauons regarding EMC and needs to be installed and put into
service according to EMC informaon provided in following tables.
Portable and mobile RF communicaons equipment can aect
Icare HOME (TA022) tonometer. The Essenal Performance of
the Icare HOME (TA022) tonometer is to measure the intraocular
pressure (IOP).
Guidance and manufacturer’s declaraon IEC 60601-1-2: Edion 4.0; 2014-02 -
Electromagnec emissions
Icare HOME (TA022) is intended for use in a home healthcare environment with
electromagnec characteriscs specied below. The user of the Icare HOME
(TA022) should assure that it is used in such an environment.
RF emissions CISPR 11 Group 1 Icare HOME (TA022) is baery operated
and uses RF energy only for its internal
funcon. 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 domesc
establishments and those directly
connected to public low-voltage power
supply network that supplies buildings
used for domesc purposes.
Harmonic emissions
IEC 61000-3-2
Not applicable Power level of Icare HOME (TA022) is
below standard requirement, baeries are
not rechargeable.
Voltage uctuaons
ickering emissions
IEC 61000-3-3
Not applicable Icare HOME (TA022) baeries are not
rechargeable.
Guidance and manufacturer’s declaraon IEC 60601-1-2: Edion 4.0; 2014-02 -
Electromagnec immunity
Icare HOME (TA022) is intended for use in a home healthcare environment with
electromagnec characteriscs specied below. The user of the Icare HOME
(TA022) should assure that it is used in such an environment.
Immunity test IEC 60601 Test
level
Compliance
level
Electromagnec
environment-Guidance
Electrostac
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 2kV, ±4kV, ±8kV,
±15 kV air
± 8 kV contact
± 15 kV air
Floors should be wood,
concrete or ceramic le.
If oors are covered with
synthec material, the
relave humidity should be
at least 30%.
Electrical fast
Transients / burst
IEC 61000-4-4
± 2 kV 100
kHz repeon
frequency
Not applicable Icare HOME (TA022)
tonometer is not
operaonal when
connected to an external
computer, Icare HOME
(TA022) baeries 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
operaonal when
connected to an external
computer, Icare HOME
(TA022) baeries are not
rechargeable.
Voltage dips,
short interrupon
and voltage
variaons 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
operaonal when
connected to an external
computer, Icare HOME
(TA022) baeries are not
rechargeable.
Power frequency
(50/60 Hz)
magnec eld
IEC 61000-4-8
30 A/m 30 A/m Power frequency magnec
elds should be at levels
characterisc of a typical
locaon in a typical
commercial or hospital
environment.
WARNING: Sources of
power frequency magnec
eld should be used no
closer than 15 cm (6
inches) to any part of Icare
HOME (TA022), including
cables specied by the
manufacturer. Otherwise,
degradaon of the
performance could result.
See also the note below.
NOTE: The measurement method of the Icare HOME tonometer is
based on magnec inducon and therefore an external magnec eld
in line with the probe may prevent the measurement. In such case the
tonometer will connuously ask to repeat the measurement. Situaon
can be solved either by removing the source of interference from the
vicinity of the device or by performing the measurement in dierent
locaon with no such interference.

Icare HOME Patient Guide ENGLISH
31www.icaretonometer.com30
GETTING SUPPORT
If you have any quesons or problems using the
care tonometer, contact your local distributor.
You can nd your local distributor here:
www.icaretonometer.com/where-to-buy/
An instructonal video can be watched here:
www.youtube.com/user/icarenland
Please, check the instrucons manual for
further informaon.
Place other appropriate contact informaon of the
supplier of the device or other source of supplies
here:
Guidance and manufacturer’s declaraon IEC 60601-1-2: Edion 4.0; 2014-02 –
Electromagnec immunity
Icare HOME (TA022) is intended for use in a home healthcare environment with
electromagnec characteriscs specied below. The user of the Icare HOME
(TA022) should assure that it is used in such an environment.
Immunity test IEC 60601 Test level Compliance
level
Electromagnec
environment-Guidance
Proximity
elds from RF
wireless co
municaons
equipment
IEC 61000-4-3
380 - 390 MHz 27 V/m;
PM 50%; 18 Hz
430 - 470 MHz 28 V/m;
(FM ±5 kHz, 1 kHz sine)
PM; 18 Hz
704 - 787 MHz 9 V/m;
PM 50%; 217 Hz
800 - 960 MHz 28 V/m;
PM 50%; 18 Hz
1700 - 1990 MHz 28 V/m;
PM 50%; 217 Hz
2400 - 2570 MHz 28 V/m;
PM 50%; 217 Hz
5100 - 5800 MHz 9 V/m;
PM 50%; 217 Hz
27 V/m
28 V/m
9 V/m
28 V/m
28 V/m
28 V/m
9 V/m
WARNING: Portable
RF communicaons
equipment (including
peripherals such as
antenna cables and
external antennas)
should be used no closer
than 30 cm (12inches) to
any part of the device1),
including cables specied
by the manufacturer.
Otherwise, degradaon
of the performance of
this equipment could
result.
Interference may
occur in the vicinity of
equipment marked with
the following symbol:
Guidance and manufacturer’s declaraon IEC 60601-1-2: Edion 4.0; 2014-02 -
Electromagnec immunity
Icare HOME (TA022) is intended for use in a home healthcare environment
withelectromagnec characteriscs specied below. The user of the Icare HOME
(TA022) should assure that it is used in such an environment.
Immunity test IEC 60601 Test
level
Compliance
level
Electromagnec environment
-Guidance
Conducted
disturbances
induced by
RF elds IEC
61000-4-6
3 V
0,15 MHz –
80 MHz
6 V in ISM and
amateur radio
bands between
0,15 MHz and
80 MHz 80 % AM
at 1 kHz
3 V
6 V
WARNING: Portable RF
communicaons 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
specied by the manufacturer.
Otherwise, degradaon of the
performance of this equiment
could result.
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz –
2,7 GHz
80% AM at 1 kHz
10 V/m WARNING: Portable RF
communicaons 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
specied by the manufacturer.
Otherwise, degradaon of the
performance of this equiment
could result.
Interference may occur in the
vicinity of equipment marked
with the following symbol:

Icare HOME Patient Guide ENGLISH
32
ICARE FINLAND OY
Äyritie 22, FI-01510 Vantaa, Finland
Icare Finland is the original developer and global leader
in handheld tonometry. Our patented technology
(over 20 patents/patent applications) combined with
ISO 13485 certified quality system has made us a
respected player in our field of expertise.
The advanced Icare®product line offers reliable,
high precision, reproducible accuracy in measuring
intraocular pressure in any circumstances, in both
experienced and inexperienced hands. A variety of
Icare®tonometers are available for several uses:
Icare®ic100, Icare®TA01i, Icare®HOME, Icare®
TONOVET, Icare®TONOLAB
Made in Finland.