I-care Icare HOME TA022 User manual

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

Icare HOME Patient Guide ENGLISH
Icare HOME (Model: TA022)
PATIENT GUIDE TA022-035 USA-2.0
Date of prinng:
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TABLE OF CONTENTS
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
Cleaning the tonometer
Clinical performance data
Geng support
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.
Posion tag = support posions for your eyes are wrien on it.
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 to be used in addion to roune clinical
monitoring of intraocular pressure (IOP) of adult
paents.
You must be cered and trained by a health care
professional for the procedures described in this
manual prior to the device being prescribed for
home use.
The health care professional will provide you with
a support posion tag that has the correct dis-
tance sengs for you if you accidently change the
distance by mistake or you need to have dierent
distance sengs to measure your other eye. You
should keep the tag with the tonometer.
Please note that paents for whom inial agreement
between Goldmann applanaon tonometry (GAT)
and Icare HOME measurements in the clinic is poor
(dierence of more than 5 mm Hg) should not be
prescribed the Icare HOME device for home use.

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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
posion. The recommended frequency of measure-
ments is 3-4 mes per day with a maximum of 5-6
mes per day.
A complete measurement is a series of six very rap-
id 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 mea-
surements, the tonometer calculates your nal eye
pressure and stores it in the tonometer’s memory.
The probe is disposable, but you can use the same
probe for both eyes if the health care professional
instructed you to measure both eyes. Dispose of
the probe in a normal trash container or a metal
waste bin aer you have taken the measurements
for both eyes.
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 im-
portant 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 in this guide before using the tonometer.
CONTRAINDICATIONS
You should not be prescribed the HOME
tonometer if you:
• Have an acve ocular infecon
(for example, pink eye)
• Had recent trauma to your eye
• Cannot demonstrate you are able to use the
Icare HOME tonometer aer training and fail
to complete the cercaon procedures.
This includes poor agreement between
Goldmann applanaon tonometry (GAT)
and Icare HOME measurements.
• 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

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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. These measurements taken
outside your oce visits may help your doctor
determine whether you have glaucoma or have
a beer understanding of your glaucoma, if you
already have a glaucoma diagnosis.
RISKS
You are likely not 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)

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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
Device 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

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Support posion tag
Support posion tag
Make sure the forehead and cheek support
posions match the posions your eye care
professional wrote on the support posion
tag for you.
The support posion tag is found in the Icare
tonometer carrying case. If needed, turn the
support wheels to your set support sengs.
Press and release the Power buon to
power on the tonometer. All 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on 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 measure-
ments 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 and uncap the container,
lt the container to allow the probe to drop into
the probe base, then press the Measure buon
briey (1 second).
The ash indicator light stops once the probe
is loaded and the MEASURE indicator starts to
ash when the tonometer is ready to measure.
Keep the probe container to reuse when ready
to dispose of the probe.
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
Cheek support Forehead support

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Red indicator light
Green indicator light
Green indicator light Green indicator light
Stand in front of a mirror and hold the
tonometer sideways in front of your face.
This will help you to align the tonometer
to your eye.
WARNING
Make sure that the probe or any part of the
tonometer does not contact your eyes.
Align the probe p with center of cornea
and rotate the tonometer unl the
probe p points straight at cornea.
WARNING
Make sure that the probe or any part of the
tonometer does not contact your eyes.
PRECAUTION
Do not cover the eye recognion sensors,
because covering the sensors causes an error.
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.
Make sure the probe is centered in sight
to ensure the probe contacts the center of
the cornea during measurement.
If the probe is not centered in your sight,
repeat steps 5 and 6.
POSITIONING THE TONOMETER
5
6
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Press the Measure buon to measure
pressure (probe will contact eye during
measurements).
Press and hold the buon (3 seconds) to collect 6
measurements in a row, or press the buon briey (1
second) 6 times to collect one measurement at a time.
PRECAUTION
If an error occurs (two short beeps and the probe
base light is ashing red), press the Measure but-
ton briey (1 second) and connue measurement.
When the measurement ends successfully,
you will hear a long beep, the probe base
light will power o, and the Done light
illuminates.
Aer using the tonometer to measure your eye
pressure, you can remove the probe by powering
o the device and allowing the probe to slide
out of the probe base. Place the probe back in
its container and dispose of it in a normal trash
container or a metal waste bin.
WARNING
You should replace the probe if it comes into
contact with your eyelashes or eyelid or you
suspect it did.
If your doctor instructed you to measure both
eyes, repeat steps 1 through 10 using your
other eye. Use a new, unused probe aer mea-
surements for both eyes have been taken.
Aer compleng all measurements, power
o the tonometer by pressing and holding the
Power buon down unl you hear 3 short
beeps.
PRECAUTION
The tonometer will power o automacally if
unused for 3 minutes.
COMPLETING THE
MEASUREMENT
9
10
11
12
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Probe base indicator light is
solid red and the Measure
indicator light turns o.
Cause: Tonometer is not held
straight.
Probe base indicator light is
ashing red and you hear 2
beeps.
Cause: Tonometer is too far
from or too close to eye or
not held straight.
Probe base indicator light is
ashing red and Repeat light
is ashing and you hear 2
beeps.
Cause: Too much variaon
between measurements or
eye recognion failed.
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.
Baery light is ashing.
Cause: Baery power is low.
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.
3. Repeat measurement.
1. Press the Measure buon to clear error.
2. 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.
3. Repeat measurement.
Contact the health care professional you received
your tonometer from or a cered service center
to have the tonometer serviced.
Change the baery.
See pages 18-19 for instrucons.
SOLUTION

Icare HOME Patient Guide ENGLISH 19www.icare-usa.com18
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.
Rechargeable baeries should not be used.
Slide the baery cover back over the baery
opening and insert the silicone lid back into
the USB port.
REPLACING THE BATTERIES
1
2
3
Silicone lid
USB port
Adjustment wheel

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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.
Make sure the baeries’ posive end
(+) is facing the baery cover.
PRECAUTION
Do not immerse the tonometer in water or any
other liquid.
PRECAUTION
Any maintenance services other than baery
replacement and cleaning must be performed
by the manufacturer or a cered service
center.
PRECAUTION
The expected service life of the device is
5 years.
CLEANING THE TONOMETER
1
2
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CLINICAL PERFORMANCE
DATA
A study was conducted with 383 paents
performing self-measurements with the Icare
HOME tonometer. A summary of the study
ndings are below:
• 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.
If you have any quesons or problems using the
Icare tonometer, call the service center:
888-389-4022 (toll-free)
or email: [email protected]
or visit Icare at: www.icare-usa.com.
Place other appropriate contact informaon
of the supplier of the device or other source of
supplies here:
GETTING SUPPORT

Icare HOME Patient Guide ENGLISH24
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
certied quality system has made us a respected player in
our eld of expertise.
e advanced Icare® product line oers reliable, high pre-
cision, 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.