I-care Icare HOME TA022 User manual

HOME
INSTRUCTION MANUAL FOR
HEALTH CARE PROFESSIONALS
ENGLISH

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Icare HOME
Icare HOME
Icare®HOME (Model: TA022) INSTRUCTION MANUAL TA022-036 EN-3.1
This device complies with:
Medical Device Directive 93/42/EEC
Canadian Medical Device Regulations
Copyright © 2014 Icare Finland Oy
Made in Finland
Icare Finland Oy
Äyritie 22, FI-01510 Vantaa, Finland
Tel. [phone], Fax [phone]
www.icaretonometer.com, info@icarenland.com
1. SAFETY INSTRUCTIONS
WARNING!
Do not bring the tonometer into contact with the eye or push it into the eye (the tip of the
probe should be 4-8mm, or 5/32-5/16” , from the eye).
WARNING!
Keep the tonometer out of the reach of children, because the probe base, battery
compartment cover and probes are so small that a child could swallow them.
WARNING!
The tonometer probe tips have not been evaluated for the presence of endotoxins. The probe
tips are for single-use only, and are packaged 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 oor.
WARNING!
The Icare HOME Tonometer (TA022) is indicated for use only under supervision of a health
care professional.
WARNING!
Health care professionals must inform patients not to modify or discontinue their treatment
plan without receiving instructions from the health care professional.
WARNING!
Do not connect the USB cable during measurement, because the tonometer does not allow
you to take any measurements when the USB is connected.
WARNING!
Do not change the batteries or probe base when the USB cable is connected.
WARNING!
No modication of this equipment is allowed.
WARNING!
Use only the original and certi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-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 eectiveness of the tonometer.
WARNING!
Federal (US) law restricts this device to sale by or on the order of a physician or properly
licensed practitioner.
0044
Icare HOME tonometer Instruction manual for health care professionals Icare HOME tonometer Instruction manual for health care professionalsEnglish English
TABLE OF CONTENTS
1. Safety instructions ............................................................................................ 3
2. Indications for use............................................................................................. 5
3. Introduction ....................................................................................................... 6
4. Package contents .............................................................................................. 6
5. Before you start................................................................................................. 7
6. Setting up the tonometer................................................................................. 8
6.1 Installing or changing the battery ....................................................................8
6.2 Turning the tonometer on ...............................................................................8
6.3 Loading the probe..............................................................................................9
7. Using the tonometer....................................................................................... 11
7.1 Choosing the measurement mode................................................................11
7.2 Adjusting the measurement position............................................................12
7.3 Automatic eye recognition..............................................................................13
7.4 Taking the measurements ..............................................................................14
8. Reading the measurement data.................................................................... 16
9. Troubleshooting............................................................................................... 17
10. Icarehometonometertrainingproceduresforcerticationofhealthcare
providers (HCP) and caregivers...................................................................... 19
11. Icarehometonometertrainingproceduresforcerticationofthepatient
for self-use........................................................................................................ 23
12. Cleaning and disinfection............................................................................... 26
13. Accessories ....................................................................................................... 26
14. Technical and performance data................................................................... 27
15. Symbols............................................................................................................. 28
16. Electromagnetic declaration.......................................................................... 29

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WARNING!
The safety and eectiveness of the Icare HOME tonometer has not been evaluated for
patients with: Uncorrected Near Visual Acuity of 20/200 or worse. Only one functional eye.
Poor or eccentric xation. Hearing impairment to the extent that the individual cannot
hear and converse with others without an assistive aid and/or sign language. High corneal
astigmatism >3D. Disabling arthritis or limited motor coordination aecting self-handling of
the Icare tonometer. Lack of comprehension or willingness to use the tonometer as instructed.
Corneal scarring. History of prior incisional glaucoma surgery or corneal surgery, including
corneal laser surgery. Microphthalmos. Buphthalmos. Contact Lens Use
Dry eyes. Blepharospasm. Nystagmus. Keratoconus. Central corneal thickness greater than
0.60mm or less than 0.50mm. Age < 40 years old.
NOTE!
• 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 ammable substances, including ammable 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 (<1m) a device causing high intensity electromagnetic
emissions, such as a cellular phone. Although the tonometer’s own electromagnetic
emissions are well below the levels permitted by the relevant standards, they may cause
interference in other, nearby devices, 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 container for
disposable needles).
• 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 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ection that causes an
error.
• The tonometer turns o automatically after 3 minutes if you do not use it.
• Do not carry out any other service procedures. Leave all other service and repairs to the
manufacturer or a certied service center.
• Update the tonometer’s time to your local time. It is done automatically by performing the
steps 1 and 2 under section 8. Reading the measurement data.
2. INDICATIONS FOR USE
WARNING!
The safety and eectiveness of the Icare HOME tonometer has not been evaluated for
patients with:
1. Uncorrected Near Visual Acuity of 20/200 or worse
2. Only one functional eye
3. Poor or eccentric xation
4. Hearing impairment to the extent that the individual cannot hear and converse
with others without an assistive aid and/or sign language
5. High corneal astigmatism >3D
6. Disabling arthritis or limited motor coordination aecting self-handling of the
Icare tonometer
7. Lack of comprehension or willingness to use the tonometer as instructed
8. Corneal scarring
9. History of prior incisional glaucoma surgery or corneal surgery, including
corneal laser surgery
10. Microphthalmos
11. Buphthalmos
12. Contact Lens Use
13. Dry eyes
14. Blepharospasm
15. Nystagmus
16. Keratoconus
17. Central corneal thickness greater than 0.60mm or less than 0.50mm
18. Age < 40 years old
The Icare HOME tonometer is a prescription device 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.
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3. INTRODUCTION
The Icare HOME tonometer is a hand-held device for self-use. The great advantage
is that a topical anesthetic is not needed.

The tonometer uses the rebound method. A small and light single-use probe makes
contact with the eye very briey. The tonometer measures the deceleration of the
probe and the rebound time, and calculates the IOP from these parameters.

A measurement sequence includes six measurements. The probe moves to
the cornea and back during every measurement. As a result, after the six
measurements the tonometer calculates the nal IOP and stores it with other
information in the tonometer’s memory, including date, time, eye identication
(right or left) and measurement quality.

The Icare HOME tonometer can record over one thousand measurement results.
You can copy the recorded measurement information to a PC through a USB cable
for management of your glaucoma patients.
4. PACKAGE CONTENTS
WARNING!
Keep the tonometer out of reach of children, because the probe base, battery compartment
cover and probes are so small that a child could swallow them.
NOTE!
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.
The package contains:
• Icare HOME tonometer
• 10 sterilized single-use probes
• 2 batteries
• USB memory stick including the instruction manual for health care professionals
and the Icare LINK software
• USB cable for connecting the Icare HOME tonometer to a PC with Icare LINK
software
• Instructions for downloading the Icare LINK software and registration of the
tonometer
• Patient guide
• Support position tags
• Warranty card
• Carrying case
5. BEFORE YOU START
Find the main parts, buttons and indicator lights of the tonometer in the below gures.
Icare HOME tonometer Instruction manual for health care professionals Icare HOME tonometer Instruction manual for health care professionalsEnglish English
LOAD
MEASURE
REPEAT
DONE
SERVICE
BATTERY
1. Probe base incorporating
indicator light
2. Eye recognition transmitter
3. Eye recognition sensor
4. Cheek support
5. Forehead support
6. Measurement button
7. Forehead support
position indicator
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. Battery cover
11. Silicon lid (USB cover)
12. Type label
8. Forehead support
adjustment wheel
9. Cheek support adjustment
wheel
FRONT PARTS TOP PARTS
BACK PANELBOTTOM PARTSSIDE PARTS
1.
6.
7.
3.
5.
4.
2.
8.
10.
13.
14.
15.
16.
17.
18.
19.
20.
11.
12.
9.

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6. SETTING UP THE TONOMETER
Setting up your Icare HOME tonometer is easy, with few steps. The following
subchapters describe how you get started.
6.1 INSTALLING OR CHANGING THE BATTERY
NOTE!
Make sure you use batteries with built-in PTC protection, for example Energizer Lithium
Photo 123 3V CR123A.
Update the tonometer’s time to your local time. It is done automatically by performing
the steps 1 and 2 under section 8. Reading the measurement data.
Lift the silicon lid that protects the USB port and keeps
the battery compartment cover in place. Open the
battery compartment cover by pressing the silicon lid
slightly and sliding the battery compartment cover as
shown in the gure left.
1. Silicon lid
2. Battery cover
Insert two CR123A lithium batteries in the correct
order: (+) end upwards as shown in the gure left.
Close the cover rmly and press the silicon lid in place
to cover the USB port.
6.2 TURNING THE TONOMETER ON
NOTE!
The tonometer turns o automatically after 3 minutes if you do not use it.
Press the power button (20) to turn the tonometer on. The lights (14-19) are
turned on briey. Following a brief pause, the Load light ashes on the back
panel to remind the user to load the single-use probe into the tonometer prior to
measurement.
6.3 LOADING THE PROBE
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 oor.
WARNING!
Use only the original and certi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-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 eectiveness of the tonometer.
Icare HOME tonometer Instruction manual for health care professionals Icare HOME tonometer Instruction manual for health care professionalsEnglish English
Opening the silicon lid and battery cover
Inserting new batteries
1.
2.
2 x CR123A
The Icare HOME tonometer uses single-use probes
that are packed in a plastic tube and wrapped in blister
packs as shown in the gures left.

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7. USING THE TONOMETER
7.1 CHOOSING THE MEASUREMENT MODE
The tonometer can operate in two modes:
Series mode
The series mode is especially
useful in self-tonometry. In
the series mode, keeping
the button pressed down
(see gure left) initiates the
measurement function, and
the tonometer takes six rapid
measurements one after the
other to obtain the nal IOP
reading.
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 briey
(1 second) for each of the six
measurements to obtain the
nal IOP reading (see gure
left).
Series mode, press the measurement button constantly.
Single mode, press the measurement button briey
(1 second) for each of the six measurements.
Icare HOME tonometer Instruction manual for health care professionals Icare HOME tonometer Instruction manual for health care professionalsEnglish English
LOAD
MEASURE
REPEAT
DONE
SERVICE
BATTERY
LOA
EASU
LO
EAS
1. Unwrap the probe. 2. Remove the lid of the
probe container as
shown in the gure
above. Point the
tonometer upward.
3. Drop the probe into
the probe base (1)
by turning the probe
container upside down.
4. Press the measurement
button (13) briey (1
second) to activate the
probe.
5. The probe moves rapidly
back and forth.
6. See that the Measure
light (15) ashes. If so,
the probe is loaded
correctly and ready for
measurement.
To load the probe:
1X

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7.2 ADJUSTING THE MEASUREMENT POSITION
WARNING!
Do not bring the tonometer into contact with the eye or push it into the eye (the tip of the
probe should be 4-8mm, or 5/32-5/16”, from the eye).
To adjust the measurement position for your patient:
1. Adjust the supports using the adjustment wheels as shown in the above gure.
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
4-8mm (5/32-5/16”) as shown in the below gure.
4. Read the distance setting (forehead A•1, A•2, etc.,
cheek B•1, B•2, etc.) between the arrows on the scale
(7) of the supports , see the gure left, and write it
down on a support position tag for the patient.
5. Do the same for the other eye as well unless only
one eye needs monitoring.
The tonometer has two
adjustable supports (4-5), one
for the forehead and one for the
cheek, as shown in the gure left.
The supports are for ensuring
accurate measurement distance
and alignment.
Tonometer forehead and cheek supports with adjustment wheels.
7.3 AUTOMATIC EYE RECOGNITION
NOTE!
Do not cover the eye recognition transmitters 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ection that causes an error.
The tonometer includes an automatic eye recognition system that identies 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 the gure below. The right-hand transmitter sends invisible infrared light to the
right and the left-hand transmitter to the left. The infrared light reects from your
nose to the sensor. The sensor knows from which transmitter the reected infrared
light came, and thus which eye you are measuring. The resulting eye indication is
included in the data that you can transfer to a PC, as described in the section 9.
Eye recognition system components.
Icare HOME tonometer Instruction manual for health care professionals Icare HOME tonometer Instruction manual for health care professionalsEnglish English
1. Left and right infrared transmitter.
2. Infrared sensor.
EYE RECOGNITION COMPONENTS
2.
1. 1.

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7.4 TAKING THE MEASUREMENTS
WARNING!
Do not bring the tonometer into contact with the eye or push it into the eye (the tip of the
probe should be 4-8mm, or 5/32-5/16”, from the eye).
The probe will make a gentle and brief contact with the eye when you take the
measurement. No topical anesthetic is needed.
To measure intraocular pressure:
1. Check that the Measure light (15) still ashes on the back panel.
2. If the Measure light does not ash, press the power button (20) and wait until
the Measure light illuminates again.
3. The patient should look straight ahead at a specic point while keeping eyes
wide open as shown in the below gure.
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
the patient’s view. See the below gures.
Correct head and eye position.
Correct measurement position.
Incorrect head and eye position.
Incorrect measurement position.
Incorrect head and eye position.
Incorrect measurement position.
5. Press the measurement button:
Single mode:
Press the button briey (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.
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.
6. If both eyes are measured repeat steps 1-5 using your other eye.
7. If an error occurs, press the Measure button briey (1 second) and continue the
measurement. See also section 9 Trouble shooting.
8. Press the power button for three seconds to turn the tonometer o.
9. Dispose of the used probe.
Icare HOME tonometer Instruction manual for health care professionals Icare HOME tonometer Instruction manual for health care professionalsEnglish English
90°
Correct measurement position.
Correct alignment of the
tonometer.
Incorrect measurement position.
Incorrect alignment of the
tonometer.
Incorrect measurement position.
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.

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8. READING THE MEASUREMENT DATA
The tonometer stores information on every complete measurement sequence of six
measurements. The stored information includes the calculated nal eye pressure
reading in mmHg, time and date of the measurement, identication of the eye (right
or left) and the quality level of the measurement.
9. 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 dierent lights and sounds mean. The indicator lights are also presented in the
gure below the table.
Error light Error
sound
Reason Action
Battery No. Battery is soon
empty.
Prepare to change batteries.
Batterylightisashing No. Battery is empty. Change batteries.
Probe base light is solid red. No. Too much vertical
tilt.
Press the measurement button again to clear the
error message.
Position the tonometer horizontally so that the
probe base light is green.
Probebaselightisashingred
andMeasurelightturnso.
Two long
beeps.
a) Probe is too far
from or too near
the eye.
b) Probe
movement was not
perpendicular to
the cornea.
Press the measurement button again to clear the
error message.
a) Set the correct distance 4-8mm (5/32-5/16”)
between the probe tip and the center of the cornea.
b) Set the probe perpendicular to the center of the
cornea.
Repeatlightisashingand
Probebaselightisashingred.
Two long
error
beeps.
a) Too much IOP
deviation during
the measurement,
because the user
did not keep the
tonometer stable.
b) Eye was not
recognized.
Press the measurement button again to clear the
error message.
a) Repeat the measurement
b) Do not move the tonometer during the
measurements, remove your hand or ngers from
the infrared transmitters and sensor, move the
patient’s hair away from his/her temple side of the
eye.
Servicelightisashingand
Probebaseisashingred.
Two long
beeps.
Incorrect or dirty
probe or probe
base.
Contact the seller to arrange sending the device for
service.
DONE
SERVICE
BATTERY
BATTERY
REPEAT
SERVICE
Icare HOME tonometer Instruction manual for health care professionals Icare HOME tonometer Instruction manual for health care professionalsEnglish English
More information about Icare LINK software
http://www.icaretonometer.com/products/icare-link/
Uploading is easy:
1. Start Icare LINK software in your PC.
2. Connect the tonometer to the 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.
3. The internal clock of the tonometer is
automatically updated to the PC’s time by the
Icare LINK software at this point.
4. Copy the data to a selected patient in the Icare
LINK software.
LINK
Connected

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10. ICARE HOME TONOMETER TRAINING
PROCEDURES FOR CERTIFICATION OF HEALTH CARE
PROVIDERS (HCP) AND CAREGIVERS
All health care providers and caregivers must receive training from a certied
trainer and be certied prior to performing tonometry or training others to perform
self-measurement tonometry with the Icare HOME tonometer.
STEP 1 – The system components
1. Open the case and identify the system components by explaining what they
are for (tonometer, single-use probes, case, batteries, Icare LINK software, user
documentation).
2. Install batteries to the tonometer as instructed in the Icare HOME user
documentation.
3. Install Icare LINK software to your PC as instructed in the Icare LINK user
documentation.
STEP 2 – Instruct the HCP or caregiver
1. Show and explain the tonometer’s user interface, including icons and status
indicators:
• O: no lights, no signals.
• Press power button: all indicator lights illuminate after a short time,
and you hear a long beep.
• Load probe: when the green Load light ashes on the back panel.
• Measure: when the green Measure light ashes on the back panel,
you are meant to take a measurement. At the same time, the
probe base light is green if the tonometer’s position is horizontal
enough, otherwise it is red. Explain that if there is an error in your
measurement, the probe base light ashes red and you hear two long
error beeps.
• Repeat: when the yellow Repeat light ashes on the back panel,
you need to repeat the measurement. At the same time, the probe
base light ashes red and you hear two short beeps. The reason is
either too much deviation in your measurement or the automatic
eye recognition system could not recognize the eye because of the
incorrect position of the tonometer.
• Done: when the green Done light illuminates on the back panel,
and you hear a long beep and the probe base light goes out, the
measurement is completed.
• Service: when the Service light and the probe base light ash red on
the back panel and you hear two long error beeps, the tonometer
needs service. At the same time the probe base light ashes red.
• Low battery: when the red Battery light illuminates on the back panel,
the battery charge is low and you should soon change the batteries.
• Empty battery: when the red Battery light ashes on the back panel,
the battery is empty and you must ask for a battery change.
OFF INTIALIZE LOAD
PROBE
MEASURE REPEAT
DONE SERVICE LOW BATTERY EMPTY
BATTERY
LOAD
MEASURE
REPEAT
DONE
SERVICE
BATTERY
LOAD
MEASURE
REPEAT
DONE
SERVICE
BATTERY
LOAD
MEASURE
REPEAT
DONE
SERVICE
BATTERY
LOAD
MEASURE
REPEAT
DONE
SERVICE
BATTERY
LOAD
MEASURE
REPEAT
DONE
SERVICE
BATTERY
LOAD
MEASURE
REPEAT
DONE
SERVICE
BATTERY
LOAD
MEASURE
REPEAT
DONE
SERVICE
BATTERY
LOAD
MEASURE
REPEAT
DONE
SERVICE
BATTERY
LOAD
MEASURE
REPEAT
DONE
SERVICE
BATTERY
LOAD
MEASURE
REPEAT
DONE
SERVICE
BATTERY
LOAD
MEASURE
REPEAT
DONE
SERVICE
BATTERY
LOAD
MEASURE
REPEAT
DONE
SERVICE
BATTERY
LOAD
MEASURE
REPEAT
DONE
SERVICE
BATTERY
LOAD
MEASURE
REPEAT
DONE
SERVICE
BATTERY
LOAD
MEASURE
REPEAT
DONE
SERVICE
BATTERY
LOAD
MEASURE
REPEAT
DONE
SERVICE
BATTERY
LOAD
MEASURE
REPEAT
DONE
SERVICE
BATTERY
LOAD
MEASURE
REPEAT
DONE
SERVICE
BATTERY
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2. Turning the tonometer on:
• Press the power button. All indicator lights on the back panel will ash
once and you will hear a short beep.
• The Load light will ash alone when the tonometer is ready to load the
probe.
• The tonometer turns o automatically after 3 minutes if you do not
use it.
3. Loading the probe:
• Unwrap the probe.
• Remove the lid of the probe container.
• By holding the probe container drop the probe into the probe base
without touching the probe.
• Press the measurement (play) button briey (1 second) to activate the
probe.
4. Adjusting the measurement distance:
• Carefully, without touching the patient’s eye, set the distance between
the tip of the probe and the center of the cornea for the patient at
4-8mm (5/32-5/16”) by turning knobs to adjust forehead and cheek
support positioning as needed.
• Write the settings down on a support position tag for the patient.
• Repeat for the patient’s other eye.
5. Explain and show illustrations for how to position the tonometer (use a
separate illustration sheet from the labeling for this):
• Sit or stand in front of a mirror and hold the tonometer sideways in
front of your face.
• Align probe tip with center of cornea and rotate the tonometer until
probe tip points straight at cornea.
• Make sure probe base light is green. If probe base light is red, make
sure you are facing straight ahead (i.e., head held at a 90° angle) and
tilt tonometer until probe base light turns green.
• The probe base light does not turn red in response to horizontal
deviations. For this reason make sure the probe is centered in sight to
ensure the probe contacts the center of cornea during measurement
even if the probe base light is green. If the probe is not centered
in your sight, repeat 5 and 6. This is very important because the
tonometer with the probe must not be tilted more than 10 degrees
away from the center of the cornea and without visualizing the probe
base light it is dicult to judge the horizontal angle of the device.
6. Explain how to take the measurement:
• Explain that the Measure light will ash when the tonometer is ready
to measure.
• Explain that the user must take six individual measurements for the
IOP result and that the results are stored in the tonometer.
• Explain that the measurement button must be depressed to obtain the
sequence of 6 measurements until a long beep is heard and the green
“Done” light is illuminated on the back panel. The probe base light
turns o at the same time.
7. Show and explain how to collect, display and store the results (for HCPs only):
• Start Icare LINK software in your PC by clicking the Icare LINK icon
• Connect the tonometer to the 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 automatically updated to the
PC’s time by the Icare LINK software at this point).
• Icare LINK software’s device tab opens and you see the results.
• Copy the results to a selected patient (it can be the default patient
“-New patient-“ that you can rename afterwards).
• The Measurements tab opens showing the copied results with date
and time information that all is now stored to the PC.
STEP 3 – Rehearsal
HCP:
1. Position the tonometer on your (HCP trainer) own eye.
2. Ask HCPs, if a given training session includes multiple health care providers, to
observe and learn.
3. Load a new probe, ask the HCPs to position the tonometer and take some self-
measurements as instructed and demonstrated.
4. Observe each HCP and, if necessary, correct the position while the HCP positions
the tonometer, say to the HCP that this is the correct position and ask the HCP to try
again.
5. Repeat 1-3 for up to ten times until the HCPs show consistent device positioning.
CAREGIVER:
6. Position the tonometer on another trainer’s eye.
7. Ask the caregiver to observe and learn.
8. Load a new probe and ask the caregiver to position the tonometer on another
trainer’s eye and to take some measurements as instructed and demonstrated.
9. Observe and, if necessary, correct the position while the caregiver positions the
tonometer, say to the caregiver that this is the correct position and ask the caregiver
to try again.
10. Repeat 1-3 for up to ten times until the caregiver shows consistent device
positioning.
STEP 4 – Reference measurement
HCP:
1. Load a new probe and carefully measure the IOP of the HCP with the tonometer once
in each eye.
CAREGIVER:
2. Load a new probe and carefully measure the IOP of another trainer once in each eye
with the tonometer.
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STEP 5 – Test measurement
HCP:
1. Load a new probe and ask the same HCP to measure his/her own IOP three times in
each eye with the same tonometer used in the reference measurement.
2. Observe if the positioning is correct. Do not supervise or interact.
CAREGIVER:
1. Load a new probe and ask the caregiver to measure IOP three times in each eye
with the same tonometer on the same trainer used in the reference measurement.
Observe if the positioning is correct. Do not supervise or interact.
STEP6–Certication
Connect device to computer and view the readings in the Icare LINK software.
TheHCPpassesthetrainingandiscertiedforperformingtonometryonpatients
with the device and for training others in self-use of the device if the following
conditions are met:
a. The reading taken by the trainer and the rst of the three readings taken by
the HCP dier by 5 mmHg or less.
b. The range (max-min) of the three readings taken by the HCP is 7 mmHg or
less.
c. The positioning of the tonometer was correct during self-use as determined
by the trainer.
HCP’s name: Date (dd mm yy):
CERTIFICATION 0 = Pass; 1 = Fail
CAREGIVER:
TheCaregiverpassesthetrainingandiscertiedforperformingtonometryon
patients with the device if the following conditions are met:
a. The reading taken by the trainer and the rst of the three readings taken by
the Caregiver dier by 5 mmHg or less.
b. The range (max-min) of the three readings taken by the Caregiver is 7 mmHg
or less.
c. The positioning of the tonometer was correct during measurement as
determined by the trainer.
Caregiver’s name: Date (dd mm yy):
CERTIFICATION 0 = Pass; 1 = Fail
11. ICARE HOME TONOMETER TRAINING
PROCEDURES FOR CERTIFICATION OF THE PATIENT
FOR SELF-USE
All patients must receive training from a certied health care professional (HCP) and
be certied prior to performing self-tonometry.
STEP 1 – Instruct the patient
1. Show and explain the tonometer’s user interface, including icons and status
indicators:
• O: no lights, no signals.
• Press power button: all indicator lights illuminate after a short time,
and you hear a long beep.
• Load probe: when the green Load light ashes on the back panel.
• Measure: when the green Measure light ashes on the back panel,
you are meant to take a measurement. At the same time, the
probe base light is green if the tonometer’s position is horizontal
enough, otherwise it is red. Explain that if there is an error in your
measurement, the probe base light ashes red and you hear two long
error beeps.
• Repeat: when the yellow Repeat light ashes on the back panel,
you need to repeat the measurement. At the same time, the probe
base light ashes red and you hear two short beeps. The reason is
either too much deviation in your measurement or the automatic
eye recognition system could not recognize the eye because of the
incorrect position of the tonometer.
• Done: when the green Done light illuminates on the back panel,
and you hear a long beep and the probe base light goes out, the
measurement is completed.
• Service: when the Service light and the probe base light ash red on
the back panel and you hear two long error beeps, the tonometer
needs service. At the same time the probe base light ashes red.
• Low battery: when the red Battery light illuminates on the back panel,
the battery charge is low and you should soon change the batteries.
• Empty battery: when the red Battery light ashes on the back panel,
the battery is empty and you must ask for a battery change or a
working tonometer from the HCP.
2. The HCP turns on the tonometer:
• Press the power button. All indicator lights on the back panel will ash
once and you will hear a short beep.
• The Load light will ash alone when the tonometer is ready to load the
probe.
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Icare HOME
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3. The HCP loads the probe:
• Unwraps the probe.
• Removes the lid of the probe container.
• Drops the probe into the probe base without touching the probe by
holding the probe container.
• Presses the measurement (play) button briey (1 second) to activate
the probe.
4. Explain and show illustrations for how to position the tonometer (use a
separate illustration sheet from the labeling for this):
• Sit or stand in front of a mirror and hold the tonometer sideways in
front of your face.
• Align probe tip with center of cornea and rotate the tonometer until
probe tip points straight at cornea.
• Make sure probe base light is green. If probe base light is red, make
sure you are facing straight ahead (i.e. head held at a 90° angle) and
tilt tonometer until probe base light turns green.
• The probe base light does not turn red in response to horizontal
deviations as illustrated in the gure on the right. For this reason make
sure the probe is centered in sight to ensure the probe contacts the
center of cornea during measurement even if the probe base light is
green. If the probe is not centered in your sight, repeat steps 5 and 6.
This is very important because the tonometer with the probe must not
be tilted more than 10 degrees away from the center of the cornea
and without visualizing the probe base light it is dicult to judge the
horizontal angle of the device.
5. Explain how to take the measurement:
• Explain that the Measure light will ash when the tonometer is ready
to measure.
• Explain that the user must take six individual measurements for the
IOP result and that the results are stored in the tonometer.
• Explain to the patient that the measurement button must be
depressed to obtain the sequence of 6 measurements until a long
beep is heard and the green “Done” light is illuminated on the back
panel. The probe base light turns o at the same time.
STEP 2 – Demonstrate measurements from your (HCP’s) own eye
1. Position the tonometer on your (HCP) own eye as instructed above.
2. Ask the patient to observe and learn.
STEP 3 – Supervised patient use of the icare home
1. Load a new probe and carefully, without touching the patient’s eye, choose the eye
and set the distance between the tip of the probe and the center of the cornea for
the patient at 4-8mm (5/32-5/16”) by turning knobs to adjust forehead and cheek
support positioning as needed. Write the settings down on a support position tag for
the patient.
2. Ask the patient to position the tonometer on the chosen eye and take some self-
measurements as instructed and demonstrated.
3. Observe and, if necessary, correct the position while the patient positions the
tonometer, say to the patient that this is the correct position and ask the patient to
try again.
4. Repeat 1-3 for up to 10 times until the patient shows consistent device positioning.
If the patient cannot consistently measure after this point the patient will be
considered to be unable to measure the IOP using the HOME device.
STEP 4 – Self-measurement by the patient
1. Load a new probe and ask the patient to measure his/her IOP three times with
the same Icare HOME tonometer.
2. Observe if the positioning is correct. Do not supervise or interact.
STEP 5 – Measurement of patient’s IOP by HCP
3. The HCP measures the IOP of the patient once with the GAT tonometer.
STEP6–Certication
Connect device to computer and view the readings in the Icare LINK software.
The patient passes the training and is certied for self-use if the following conditions
are met:
a. The rst of the three HOME readings taken by the patient and the GAT
result measured by the HCP dier by 5 mmHg or less.
b. The range (max-min) of the three readings taken by the patient is 7 mmHg
or less.
c. The positioning of the tonometer was correct during self-use as
determined by the HCP.
Patient ID: Date (dd mm yy):
CERTIFICATION 0 = Pass; 1 = Fail EYE 0 = Right; 1 = Left, 2 = Both
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14. TECHNICAL AND PERFORMANCE DATA
Type TA022
Dimensions: approximately 11cm x 8cm x 3cm.
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): ±1,2mmHg (<20 mmHg) and
±2.2 mmHg (≥20 mmHg).
Repeatability (coecient 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.
The tonometer has BF-type electric shock protection.
Operation environment:
Temperature: +10 °C to +35 °C
Relative humidity: 30% to 90%
Atmospheric pressure: 800hPa – 1060hPa
Storage environment:
Temperature: -10 °C to +55 °C
Relative humidity: 10% to 95%
Atmospheric pressure: 700hPa – 1060hPa
Transport environment:
Temperature: -40 °C to +70 °C
Relative humidity: 10% to 95%
Atmospheric pressure: 500hPa – 1060hPa
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
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12. CLEANING AND DISINFECTION
NOTE!
Do not carry out any other service procedures. Leave all other service and repairs to the
manufacturer or a certied service center.
You must clean the forehead and cheek supports for each new patient. Use a wipe
dampened with a 70% isopropyl alcohol solution. Do not immerse the tonometer in
water or other liquid. The tonometer must not be immersed or cleaned using too
much water.
13. ACCESSORIES
Part number Product Description Weight Dimensions
540 Probe base 4g 7 mm x 38 mm
TA022-001 Probe base collar 2g 20 mm x 15 mm
560 Wrist strap 3g 270 mm x 10 mm x 10 mm
TA022-044 Carrying case 210g 270 mm x 135 mm x 60 mm
7179 Battery cover 3g 26 mm x 23 mm x 7 mm
TA022-035 Patient guide 33g 210 mm x 90 mm x 2 mm
571 Battery 3 V, CR123A 17g 17 mm x 35 mm
TA022-037 Support position tags 40g 70 mm x 41 mm x 13 mm
575 USB cable 23g 1m

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Icare HOME
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15. SYMBOLS 16. ELECTROMAGNETIC DECLARATION
Caution
See operating
instructions for more
information
BF-type device
Single-use disposable
Serial number
Use by <date>
Manufacturer
Keep dry
Manufacturing date
Lot number
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)
SN
STERILE R
LOT
Guidance and manufacturer’s declaration–Electromagnetic emissions
IcareHOMEisintendedforuseintheelectromagneticenvironmentspeciedbelow.
The user of the Icare HOME should assure that it is used in such an environment.
RF emissions CISPR 11 Group 1 Icare HOME is battery operated and use RF energy only for its internal
function. Therefore, its RF emissions are low and are not likely to cause
any interference in nearby equipment.
RF emissions CISPR 11 Class B Icare HOME 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.
Guidance and manufacturer’s declaration– Electromagnetic immunity
IcareHOMEisintendedforuseintheelectromagneticenviromentspeciedbelow.
The customers or users of Icare HOME should assure that it is used in such enviroment.
Immunity test IEC 60601 Test
level
Compliance
level
Electromagnetic environment-Guidance
Electrostatic discharge (ESD) IEC
61000-4-2 ± 6 kV contact ±8 kV air Complies Floors should be wood, concrete or ceramic tile. If oors are covered with synthetic material, the
relative humidity should be at least 30%.
Power frequency (50/60 Hz)
magnetic eld IEC 61000-4-8
3 A/m Complies Power frequency magnetic elds should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
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.
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NOTES
Guidance and manufacturer’s declaration – Electromagnetic immunity
IcareHOMEisintendedforuseintheelectromagneticenvironmentspeciedbelow.
The customer or the user of the Icare HOME should assure that it is used in such an environment.
Immunity test IEC 60601
Test level
Compliance level Electromagnetic environment-Guidance
Radiated RF
IEC 6100-4-3
3 V/m
80MHz to 2,5 GHz
3 V/m Portable and mobile RF communications
equipment should be used no closer to any part
of the Icare HOME, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
d = 1.2 √P
d = 1.2 √P 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2 5 GHz
Field strengths from xed RF transmitters, as
determined by an electromagnetic site survey
should be less than the compliance level in each
frequency range.
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and
reection from structures, objects and people.
Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be
considered. If the measured eld strength in the location in which the Icare HOME is used exceeds the applicable RF
compliance level above, the Icare HOME should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the Icare HOME.
Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communications equipment and
Icare HOME
Icare HOME is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the Icare HOME can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and Icare HOME as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum output power
of transmitter
(W)
Separation distance according to frequency of transmitter
150 kHz to 80 MHz
d= 1,2 √P 80 MHz to 800 MHz d= 1,2 √P 800 MHz to 2,5 GHz d= 1,2 √P
0,01 0.12 0.12 0.23
0,1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.2
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance can be
estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power
rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and
reection from structures, objects and people.
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