icare HOME TA022 User manual

1www.icare-usa.com
TA022-035-USA-1.4
PATIENT
Federal (US) law restricts this device to
sale by or on the order of a physician
or properly licensed practitioner.
Belongs to:
GUIDE
ENGLISH

Icare HOME Patient Guide
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TABLE OF CONTENTS
Safety instrucons
Glossary
Introducon
How does the tonometer work
Contraindicaons
Risks
Benets
Tonometer overview
Preparing the tonometer for use
Posioning the tonometer
Compleng the measurement
Troubleshoong
Replacing the baeries
Replacing the brobe base
Cleaning the tonometer
Transferring the measurement data
Clinical performance data
Lifeme
Technical data
Symbols
Electromagnec declaraon
Geng support
Icare HOME Patient Guide ENGLISH
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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Icare HOME (Model: TA022) PATIENT
GUIDE TA022-035-USA-3.1
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
Icare Finland Oy Äyritie
22, 01510 Vantaa
Finland

Icare HOME Patient Guide ENGLISH
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 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 (same probe to
measure both eyes) 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 Patient Guide ENGLISH4
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er-
ies at least every 12 months and changing 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.

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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 ENGLISH6
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.

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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 prescripon
device intended as an adjunct to the roune
clinical monitoring of intraocular pressure (IOP)
of adult paents.
HOW DOES THE
TONOMETER WORK
The tonometer measures your eye pressure using a
disposable probe that gently contacts your eye
during the measurement. Take measurements at
times directed by your physician.
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.

Icare HOME Patient Guide ENGLISH8
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.

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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 in
obtaining clinical IOP measurements (for
example, due to eyelid squeezing
or tremor)

Icare HOME Patient Guide ENGLISH10
TONOMETER OVERVIEW
Cheek support
adjustment wheel
FRONT
BACK
Measure buon
LOAD indicator
MEASURE indicator
REPEAT indicator
DONE indicator
SERVICE indicator
BATTERY indicator
Power buon

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BOTTOM
Measure buon
LOAD indicator
MEASURE indicator
REPEAT indicator
DONE indicator
SERVICE indicator
BATTERY indicator
Power buon
Cheek support
posion indicator
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 ENGLISH12
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, sterile probe for each
measurement of both eyes.
• 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.
Press MEASURE buon once to acvate the
probe. MEASURE light ashes when
tonometer is ready to take measurement.
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

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Icare HOME Patient Guide ENGLISH14
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 solid 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 green probe
base light ring symmetrically to ensure
the probe contacts the center of the
cornea during measurement.
POSITIONING THE TONOMETER
5
6
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Red indicator lightGreen indicator light
Correct
posion
Slightly
lted
horizontally
Slightly
lted
vercally

Icare HOME Patient Guide ENGLISH16
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 long beep to collect 6 measurements in a row
or press the Measure buon 6 individual mes to
collect each measurement separately.
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
with a green check mark.
If your doctor instructed you to measure both
eyes, repeat steps 1 through 9 for your other eye.
The probes are single use. Use one probe to
measure both eyes then discard. Use a new probe
for next set of measurements.
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 or unl you
hear 3 consecuve 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
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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 long beep to collect 6 measurements in a row
or press the Measure buon 6 individual mes to
collect each measurement separately.
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
with a green check mark.
If your doctor instructed you to measure both
eyes, repeat steps 1 through 9 for your other eye.
The probes are single use. Use one probe to
measure both eyes then discard. Use a new probe
for next set of measurements.
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 or unl you
hear 3 consecuve 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.
Steps
1-10

Icare HOME Patient Guide ENGLISH18
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

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ERROR MESSAGE
1. Make sure you are facing straight
ahead (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 or
temple 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. If this does not resolve the issue, 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 ENGLISH20
i
i
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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 back onto the probe base.
REPLACING THE BATTERIES
REPLACING THE PROBE BASE
1
1
2
3
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.