I-care HOME2 User manual
EN INSTRUCTION MANUAL
FI KÄYTTÖOHJE
SV ANVÄNDARHANDBOK
DA BRUGERMANUAL
NO BRUKSANVISNING
EL ΕΓΧΕΙΡΙΔΙΟ ΟΔΗΓΙΩΝ
Instruction Manual
iCare HOME2
2 3
The information in this document is subject to change without prior notice. Should a conflict
situation arise concerning a translated document, the English language version shall prevail.
This device complies with:
Medical Device Directive 93/42/EEC
RoHS Directive 2011/65/EU
Radio equipment directive 2014/53/EU
0598
Copyright © 2021 Icare Finland Oy. All rights reserved. iCare is a registered trademark of Icare
Finland Oy, all other trademarks are the property of their respective owners. Made in Finland.
Android is a registered trademark or trademark of Google Inc. Google Play is a trademark of
Google LLC. App Store is a trademark of Apple Inc.
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc.
and any use of such marks by Icare Finland Oy is under license. Other trademarks and trade
names are those of their respective owners.
Icare Finland Oy
Äyritie 22, FI-01510 Vantaa, Finland
Tel. +358 9 8775 1150
www.icare-world.com, info@icare-world.com
English
Contents
1 Safety information ....................................................................................... 5
1.1 For healthcare professionals ......................................................... 5
1.2 For patients and healthcare professionals................................. 5
2 Intended use................................................................................................. 8
3 Clinical benefits ........................................................................................... 8
4 Essential performance................................................................................ 8
5 Restrictions of use....................................................................................... 9
5.1 Contraindications ............................................................................. 9
5.2 Environmental restrictions............................................................. 9
6 Introduction .................................................................................................10
6.1 Information on intraocular pressure............................................11
6.2 Support materials ............................................................................11
6.3 Sales package contents.................................................................12
6.4 Buttons and parts ...........................................................................13
7 Get started ...................................................................................................14
7.1 Insert the batteries .........................................................................14
8 Take a measurement..................................................................................15
8.1 Insert the probe...............................................................................15
8.2 Switch on the tonometer .............................................................. 17
8.3 Find the correct measurement position.................................... 17
8.4 Adjust the supports and position the tonometer....................18
8.5 Measure your eye pressure .......................................................... 20
8.6 Measure your eye pressure in the supine position................. 22
8.7 Errors during the measurement ................................................. 23
8.8 Check the measurement result .................................................. 24
8.9 View your previous measurements ............................................ 24
9 Switch off the tonometer and dispose of the probe......................... 25
10 Tonometer modes...................................................................................... 25
10.1 Practice mode................................................................................. 25
10.2 Rental mode .................................................................................... 26
10.3 Hide mode ....................................................................................... 26
11 Tonometer settings.....................................................................................27
11.1 Language settings ...........................................................................27
11.2 Time settings....................................................................................27
11.3 Date settings ....................................................................................27
11.4 Volume settings .............................................................................. 28
11.5 Probe base light settings.............................................................. 28
11.6 Display brightness settings .......................................................... 28
11.7 Tonometer’s serial number and firmware version .................. 28
4 5
12 iCare software system .............................................................................. 28
12.1 Compliancy standards................................................................... 29
12.2 Install the software........................................................................ 29
12.3 Transfer measurement data to iCare CLINIC or
iCare CLOUD.................................................................................... 30
12.4 Bluetooth notifications and errors..............................................31
13 Troubleshooting.......................................................................................... 32
14 Maintenance................................................................................................ 33
14.1 Replace the probe base................................................................ 33
14.2 Clean and disinfect the tonometer............................................ 35
14.3 Lifetime ............................................................................................ 35
14.4 Return the tonometer for service or repair.............................. 35
14.5 Recycle ............................................................................................. 35
15 Glossary ....................................................................................................... 36
16 Accessories, parts, and other supplies................................................. 36
17 Technical information ................................................................................37
17.1 Technical description .....................................................................37
17.2 System requirements for iCare CLINIC ......................................37
17.3 IT network specifications ............................................................. 38
17.4 Intended information flow ........................................................... 38
17.5 Potential hazardous situations resulting from the failure
of the IT network............................................................................ 38
17.6 Required characteristics of the IT network.............................. 39
17.7 Performance data........................................................................... 39
17.8 Symbols and trademarks ............................................................. 40
17.9 Information for the user regarding the radio
communication part of the tonometer ...................................... 41
17.10 Bluetooth module information.....................................................41
17.11 Statement of compliance..............................................................41
17.12 Electromagnetic declaration........................................................ 42
1 Safety information
1.1 For healthcare professionals
WARNING! Healthcare professionals must inform patients not to modify or discontinue
their treatment plan without receiving instructions from the healthcare professional.
WARNING! When reading the measurement data in a clinic or hospital environment,
make sure the tonometer and the computer or mobile device which are not medical
equipment are located outside of the patient environment, i.e. 1.5 m (5 feet) from the
patient.
WARNING! Connection of the tonometer to IT networks including other equipment could
result in previously unidentified risks to patients, operators, or third parties.
WARNING! The responsible organization should identify, analyze, evaluate, and control
any additional risks resulting from the tonometer connected to IT networks, including
other equipment.
PRECAUTION! Certain microbiological agents (for example, bacteria) can be transmitted
from the forehead or cheek support. To prevent this, clean the forehead and cheek
supports with disinfectant for each new patient.
PRECAUTION! Changes to the IT network could introduce new risks requiring additional
analysis by the responsible organization. The changes include:
• changes in the IT network configuration
• connection of additional items to the IT network
• disconnecting items from the IT network
• update or upgrade of equipment connected to the IT network
1.2 For patients and healthcare professionals
WARNING! The tonometer is intended for personal use only. Measuring other people,
animals, or objects is forbidden.
WARNING! Do not use the tonometer in the restricted environments defined in chapter
“5.2 Environmental restrictions” of this manual.
WARNING! Patients must not modify or discontinue their treatment plan without
receiving guidance from a healthcare professional.
WARNING! The tonometer must not be dropped. To avoid dropping the tonometer and
to ensure safe handling, always use the wrist strap to keep the tonometer attached to
your wrist when in use. If the tonometer is dropped and the tonometer casing opens,
press the casing to close the openings.
WARNING! Removing, covering, or defacing any label or sign on the tonometer voids all
the responsibilities and liabilities of the manufacturer concerning the safety and
effectiveness of the tonometer.
WARNING! Remove the batteries from the tonometer if it is not likely to be used for
some time.
WARNING! Only probes are intended for contacting the eye. Avoid touching the eye with
other parts of the tonometer. Do not push the tonometer into the eye.
WARNING! If you need help in using the iCare HOME2 tonometer, contact your
healthcare professional.
WARNING! Use of eye drops right before the measurement or topical anesthesia may
affect the measurement result.
WARNING! Do not use probes without a plastic tip. Do not use deformed probes.
Contact the manufacturer or local distributor if you notice faulty probes or probe
packages.
WARNING! Use only original and certified probes made by the manufacturer. The probes
are for single use (single pair of measurement sequences) only. Each session is defined
by one successful measurement in both eyes, but in case either eye is inflamed or
infected, measure the healthy eye first.
WARNING! Use probes taken only from an intact, original packaging. The manufacturer
cannot guarantee the sterility of the probe once the seal is compromised.
Re-sterilization or re-use of the probe could result in incorrect measurement values,
breakdown of the probe, cross-contamination of bacteria or viruses, and infection
of the eye. Re-sterilization or re-use will void all the responsibilities and liabilities
of the manufacturer concerning the safety and effectiveness of the tonometer.
WARNING! To prevent contamination, keep unused probes in their box. Do not touch
WARNING! Shorten the cheek and forehead supports of the tonometer only slightly at
6 7
WARNING! Do not connect anything to the tonometer’s USB port but the USB cable
supplied with the tonometer.
WARNING! Keep the USB cable out of the reach of children and pets due to the risk of
strangulation.
WARNING! The tonometer’s batteries are not rechargeable. Do not try to charge the
tonometer with USB chargers connected to a mains voltage.
WARNING! Do not connect the USB cable to the tonometer’s USB port except when
uploading patient measurement data. Do not take any measurements when the USB
cable is connected.
WARNING! The tonometer should only be opened by qualified iCare service personnel.
The tonometer does not contain any user-serviceable parts, apart from the batteries
other than changing the batteries at least annually and the probe base every six months.
If there is a reason to believe that the servicing of the tonometer is necessary, contact
the manufacturer or local distributor.
WARNING! The tonometer must not be repaired or re-assembled by any other than the
manufacturer or its authorized service center. If the tonometer is broken, do not use it.
Take it to an authorized iCare service center for repair.
WARNING! To avoid possible damage, keep the tonometer out of the reach of children
and pets. The probe base, battery cover, screws, collar, and probes are small objects and
may be accidentally swallowed.
WARNING! Do not change the batteries or the probe base when the USB cable is
connected.
WARNING! Servicing or maintenance actions must not be performed while the
tonometer is in use.
WARNING! The tonometer must be switched off when the probe base is changed.
WARNING! The probe base must be changed, not cleaned.
WARNING! Never immerse the tonometer in liquid. Do not spray, pour, or spill liquid
Immediately remove any liquid from the surface of the tonometer.
WARNING! Do not modify the tonometer in any way. Changes or modifications not
expressly approved by the manufacturer could void the user’s authority to operate the
tonometer.
WARNING! Use of this equipment adjacent to or stacked with other equipment should
be avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are
operating normally.
WARNING! Use of accessories, transducers, and cables other than those specified or
provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this equipment
and result in improper operation.
WARNING! Interference may occur in the vicinity of equipment marked with the
non-ionizing radiation symbol.
WARNING! Sources of power frequency magnetic field should be used no closer than
manufacturer, to avoid the degradation of performance.
WARNING! Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30 cm (12 inches)
to any part of the tonometer, including the cables specified by the manufacturer, to
avoid the degradation of performance.
PRECAUTION! Read this manual carefully, as it contains important information about
using and servicing the tonometer.
PRECAUTION! Use the tonometer only for measuring intraocular pressure. Any other use
is improper. The manufacturer is not liable for any damage arising from improper use,
PRECAUTION! Do not use the tonometer near inflammable substances, including
inflammable anesthetic agents.
PRECAUTION! Report any serious incidents related to the tonometer to your competent
health authority and the manufacturer or the manufacturer’s representative.
PRECAUTION! When removing the tonometer from its packaging, and each time before
use, visually inspect the tonometer for any external damage, particularly for possible
damage to the tonometer casing. If you suspect damage to the tonometer, contact the
manufacturer or the distributor of the tonometer.
PRECAUTION! Use only the battery type specified in the technical specification section
of this manual. Do not use rechargeable batteries, as they do not have sufficient voltage.
PRECAUTION! The tonometer switches off the display when it has not detected any
movement for 15 seconds. The tonometer switches off automatically if it has not been
used for 3 minutes.
PRECAUTION! Before taking measurements, update the tonometer’s time to your local
time manually from the tonometer’s settings or automatically by connecting the
tonometer to the iCare PATIENT2 application or to the iCare EXPORT software.
PRECAUTION! Do not cover the eye recognition transmitters or sensor during the
measurement, for example with your fingers. Keep your hand, hair, and objects such
that causes an error.
PRECAUTION! Eye detection is based on the difference of infrared reflections received
from the transmitters: the nose side reflects more than the temple side. If the
transmitters become dirty, the recognition may be interfered.
PRECAUTION! To ensure the correct functioning of the tonometer, change the probe
base every six months.
PRECAUTION! Non-ME equipment (computer or mobile device) used in the system
requirements for multimedia equipment: CISPR 32 and CISPR 35.
PRECAUTION! The measurement method of the tonometer is based on a magnetically
induced motion of a probe and therefore an external magnetic or radiated RF
electromagnetic field disturbing the probe may prevent the measurement. In such a
case the tonometer continuously displays error messages during measurement and asks
you to repeat the measurement. Situation can be solved either by removing the source
of interference from the vicinity of the tonometer or by performing the measurement in
different location with no such interference.
PRECAUTION! The measurement data transfer may be interrupted during electromagnetic
data is transferred successfully.
PRECAUTION! Portable and mobile RF communications equipment can affect the
tonometer.
PRECAUTION! 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.
8 9
2 Intended use
The iCare HOME2 tonometer is a device intended for monitoring of
intraocular pressure (IOP) of the human eye. It is indicated for use by
patients or their caregivers.
3 Clinical benefits
With the iCare HOME2 tonometer, you can measure your eye pressure at
various times during the day and night. These measurements taken outside
your clinic visits may help your doctor better understand your eye pressure.
High-peak and mean eye pressure as well as large eye pressure fluctuations
are risk factors for glaucoma progression (1, 2). There may be eye pressure
peaks and fluctuations outside of office hours and those would remain
undetected without home eye pressure monitoring (3, 4, 5). Diurnal eye
pressure data helps in treatment decisions, for example, when evaluating
medication (6, 7).
This eye pressure measurement tool is an adjunct to the standard of care
and does not replace the conventional methods used to diagnose and
manage patients, nor should it alter the follow-up schedule otherwise
indicated for a particular patient.
4 Essential performance
The essential performance of the iCare HOME2 tonometer is to measure
intraocular pressure with specified accuracy, to display the measurement
result or error conditions, and to transfer the data into the iCare software
system.
If the essential performance of the tonometer is lost or degraded due
to electromagnetic disturbances, the tonometer continuously displays
error messages during the measurement and asks you to repeat the
measurement. See chapter “17.12 Electromagnetic declaration” for
instructions on proper electromagnetic environment.
5 Restrictions of use
WARNING! The tonometer is intended for personal use only. Measuring other people,
animals, or objects is forbidden.
WARNING! Do not use the tonometer in the restricted environments defined in chapter
“5.2 Environmental restrictions” of this manual.
PRECAUTION! Use the tonometer only for measuring intraocular pressure. Any other use
is improper. The manufacturer is not liable for any damage arising from improper use,
PRECAUTION! Do not use the tonometer near inflammable substances, including
inflammable anesthetic agents.
5.1 Contraindications
You should not use the iCare HOME2 tonometer if you:
• have an active ocular infection (for example, pink eye or infectious
conjunctivitis)
• have had a recent trauma to your eye including corneal laceration or
corneal or scleral perforation
• have disabling arthritis or difficulty handling the tonometer
• have severe difficulty with opening your eyes, including abnormal
contractions or twitches of the eyelid (blepharospasm)
• have involuntary, rapid, and repetitive movement of the eyes (nystagmus)
You may not be eligible for use of the iCare HOME2 tonometer if you:
• have poor uncorrected near vision of 20/200 or worse
• have only one working eye
• have poor or off-center visual fixation
• have poor hearing without an aid or communicate using sign language
• use contact lenses
• have dry eyes
• have keratoconus (a corneal disorder)
• have a congenitally (from birth) small eye (microphthalmos)
• have an enlarged eye from childhood glaucoma (buphthalmos)
The safety and effectiveness of the iCare HOME2 tonometer has not
been evaluated for patients with:
• high corneal astigmatism (>3d)
• history of prior invasive glaucoma surgery or corneal surgery including
corneal laser surgery (for example, LASIK)
• corneal scarring
• very thick or very thin corneas (central corneal thickness greater than
• whom it is already difficult to obtain clinical intraocular measurements
• cataract extraction within the last 2 months
5.2 Environmental restrictions
The iCare HOME2 tonometer should not be used in medical vehicles or
similar environments where the vibration or noise levels are so high that the
user cannot hear error signals.
See chapter “17.12 Electromagnetic declaration” for the correct
electromagnetic use environment.
NOTE! When not in use, keep the tonometer in the carrying case to protect it from dirt and
direct sunlight that might cause damage to the tonometer.
1) Asrani et al., “Large diurnal fluctuations in
intraocular pressure are an independent risk factor
134-142.
2) Cvenkel et al., “Self-monitoring of intraocular
pressure using iCare HOME tonometry in clinical
practice.” Clin Ophthalmol 13, 841-847 2019 May 10.
3) Barkana et al., “Clinical utility of Intraocular
pressure monitoring outside of normal office hours
in patients with glaucoma.” Arch. Ophthalmol.
4) Nakakura et al., “Relation between office
intraocular pressure and 24-hour intraocular
pressure in patients with primary open-angle
glaucoma treated with a combination of topical
5) Hughes E et al., “24-hour monitoring of
intraocular pressure in glaucoma management:
6) Awadalla et al., “Using Icare HOME tonometry
for follow-up of patients with open-angle glaucoma
before and after selective laser trabeculoplasty.”
Clinical & experimental ophthalmology vol. 48,3
(2020): 328-333.
7) Astakhov et al., “The role of self-dependent
tonometry in improving diagnostics and treatment of
patients with open angle glaucoma.” Ophthalmology
10 11
6 Introduction
WARNING! Healthcare professionals must inform patients not to modify or discontinue
their treatment plan without receiving instructions from the healthcare professional.
WARNING! Patients must not modify or discontinue their treatment plan without
receiving guidance from a healthcare professional.
WARNING! The tonometer is intended for personal use only and measuring other
people, animals, or objects is forbidden.
WARNING! If you need help in using the iCare HOME2 tonometer, contact your
healthcare professional.
PRECAUTION! Do not cover the eye recognition transmitters or sensor during the
measurement, for example with your fingers. Keep your hand, hair, and objects such as
pillows away from the temple side of your eye, as they produce an infrared reflection
that causes an error.
PRECAUTION! Read this manual carefully, as it contains important information about
using and servicing the tonometer.
PRECAUTION! Report any serious incidents related to the tonometer to your competent
health authority and the manufacturer or the manufacturer’s representative.
The iCare software system consists of the following:
• iCare HOME2 tonometer
• iCare CLINIC, a browser-based software service with which the healthcare
professional and patient can view the measurement data
• iCare CLINIC On-premises, a version of iCare CLINIC that can be installed
on a hospital’s or clinic’s own server. With iCare CLINIC On-premises,
or uploaded from outside, only from within hospital or clinic using the
iCare EXPORT.
• iCare PATIENT2 mobile application with which the patient and healthcare
professionals can view measurement data and transfer it to the iCare
CLINIC cloud service
• iCare EXPORT computer software with which the patients and healthcare
professionals can view the measurement data and transfer it into the
iCare CLINIC cloud service or iCare CLINIC On-premises
See chapter “12 iCare software system” for details.
If a patient’s tonometer is not registered to a healthcare professional’s
iCare CLINIC account, the patient can store their measurement data to a
private account in the iCare CLOUD service. For information on how to set
up a private account, read the Getting started guide in the tonometer’s
carrying case.
With the iCare HOME2 tonometer, you can measure your eye pressure.
During the measurement, the tonometer’s probe gently touches your eye six
times. After the six successful measurements, the tonometer calculates your
eye pressure and stores it in the tonometer’s memory. The device history
shows the 100 most recent measurement results.
If your healthcare professional instructed you to measure both eyes, you can
use the same probe for both. After you have taken the measurements, place
the probe back in its container and dispose of it in a mixed waste bin. Use a
new, unused probe when you take a measurement the next time.
You can measure your eye pressure when you are sitting, standing, or lying
down. The tonometer includes infrared eye recognition sensors to identify
which eye, right or left, you are measuring.
After the measurement, you can transfer the measurement data to
iCare CLINIC using your computer or mobile device.
Familiarize yourself thoroughly with the tonometer, software, and the
operational procedures before use.
6.1 Information on intraocular pressure
The normal eye pressure ranges from 10 to 20 mmHg (1). The risk for
glaucoma increases if the eye pressure is above this range. In normal tension
glaucoma, the optic nerve is damaged even though the eye pressure is not
very high. The optimal target pressure in glaucoma and ocular hypertension
needs to be defined case by case. Ask your healthcare professional for
your target eye pressures. Agree when you need to contact your healthcare
professional about your eye pressure measurement results.
Follow your healthcare professional’s instructions on the frequency of
measurements. Unless otherwise instructed, the recommended frequency
of measurements is 3-6 times a day. Keep a record of your eye pressure
for your healthcare professional. A single measurement does not provide
accurate information on your eye pressure level. You need to take and record
several measurements over time. Try to measure your eye pressure at the
same times each day for consistency.
An elevated eye pressure as well as fluctuations in the eye pressure are
underlying risk factors for glaucoma (2,3). When you measure your eye
pressure in a variety of situations and at different times of the day, you and
your healthcare professional get a comprehensive view of the changes in
your eye pressure and the effectiveness of your medication.
6.2 Support materials
To learn to use the tonometer, read this manual carefully. The USB stick
provided in the tonometer’s sales package contains a quick guide, this
instruction manual, and a training video to help you get started with
the tonometer. If you have problems using the tonometer, contact the
organization from which you obtained the tonometer or Icare Finland.
You can find contact information for Icare Finland at www.icare-world.com.
1) Dan T. Gudgel, “Eye Pressure.” American Academy
of Ophthalmology, 2018 [https://www.aao.org/eye-
health/anatomy/eye-pressure]
2) Asrani et al., “Large diurnal fluctuations in
intraocular pressure are an independent risk
3) Cvenkel et al., “Self-monitoring of intraocular
pressure using iCare HOME tonometry in clinical
practice.” Clin Ophthalmol 13, 841-847 2019 May 10.
12 13
6.3 Sales package contents
AA/LR6
The iCare HOME2 sales package contains:
• iCare HOME2 tonometer
• Carrying case
• Instruction Manuals
• Probe applicator
• Quick Guides
• Screwdriver
• Spare probe base
• Sterilized single-use probes
• USB-C to Micro-USB B adapter
• USB cable for PC connection (USB-C to USB-A)
• USB cable for mobile device connection (USB-C to USB-C)
• USB stick with instruction materials
• Warranty card
• Wrist strap
• 4 x AA 1.5 V Alkaline batteries
6.4 Buttons and parts
WARNING! Removing, covering, or defacing any label or sign on the tonometer voids all
the responsibilities and liabilities of the manufacturer concerning the safety and
effectiveness of the tonometer.
1
2
5
3
4
8
9 1011 12
12
14
13
15
16
67
1. Measure button
2. Navigation buttons
3. Select button
4. Return button
5. Display
6. Battery cover
7. USB-C port and USB cover
8. Wrist strap
9. Forehead support
10. Cheek support
11. Probe
12. Probe base
13. Infrared LED transmitters
14. Infrared LED sensor
15. Probe applicator
16. Screwdriver
14 15
7 Get started
WARNING! The tonometer must not be dropped. To avoid dropping the tonometer and
to ensure safe handling, always use the wrist strap to keep the tonometer attached to
your wrist when in use. If the tonometer is dropped and the tonometer casing opens,
press the casing to close the openings.
PRECAUTION! When removing the tonometer from its packaging, and each time before
use, visually inspect the tonometer for any external damage, particularly for possible
damage to the tonometer casing. If you suspect damage to the tonometer, contact the
manufacturer or the distributor of the tonometer.
7.1 Insert the batteries
WARNING! Remove the batteries from the tonometer if it is not likely to be used for
some time.
PRECAUTION! Use only the battery type specified in the technical specification section
of this manual. Do not use rechargeable batteries, as they do not have sufficient voltage.
NOTE! The quality of the batteries affects the number of measurements that can be taken with
a single set of batteries.
NOTE! Replace all batteries with new ones at the same time.
1. Use the screwdriver to open the battery cover and open it up.
The batteries are in the tonometer carrying case under the box of
probes.
AA/LR6
AA/LR6
AA/LR6
2. Insert the batteries according to the markings inside the battery
compartment.
AA/LR6
AA/LR6
3. Close the battery cover and lock the cover with the screwdriver.
AA/LR6
NOTE! The battery charge level is shown when you switch the tonometer on:
8 Take a measurement
WARNING! Only probes are intended for contacting the eye. Avoid touching the eye with
other parts of the tonometer. Do not push the tonometer into the eye.
WARNING! Use of eye drops right before the measurement or topical anesthesia may
affect the measurement result.
PRECAUTION! Before taking measurements, update the tonometer’s time to your
To ensure a reliable measurement result:
• Take the measurement in a quiet place
• Remain still and avoid talking and looking around during the measurement
If you feel unsure about taking the measurement, practice the measurement
in the practice mode of the tonometer. See chapter “10.1 Practice mode”.
8.1 Insert the probe
WARNING! Do not use probes without a plastic tip. Do not use deformed probes.
Contact the manufacturer or local distributor if you notice faulty probes or probe
packages.
WARNING! Use only original and certified probes made by the manufacturer. The probes
are for single use (single pair of measurement sequences) only. Each session is defined
by one successful measurement in both eyes, but in case either eye is inflamed or
infected, measure the healthy eye first.
WARNING! Use probes taken only from an intact, original packaging. The manufacturer
cannot guarantee the sterility of the probe once the seal is compromised. Re-sterilization
or re-use of the probe could result in incorrect measurement values, breakdown of
Re-sterilization or re-use will void all the responsibilities and liabilities of the
manufacturer concerning the safety and effectiveness of the tonometer.
WARNING! To prevent contamination, keep unused probes in their box. Do not touch
1. Do not use a probe if it has touched your hand, a table, or other
non-sterile surface.
16 17
2. Place the probe applicator over the probe base.
3. Open the packaging.
4. Remove the cap.
5. Drop the probe from the container to the probe applicator.
6. Remove the probe applicator.
8.2 Switch on the tonometer
PRECAUTION! The tonometer switches off the display when it has not detected any
movement for 15 seconds. The tonometer switches off automatically if it has not been
used for 3 minutes.
Make sure that the date and time shown on the display are correct. If they
are incorrect, update them from the tonometer’s settings or by connecting
the tonometer to the iCare PATIENT2 application or to the iCare EXPORT
software.
Press down until you hear a beep. The text “Start” is shown on the
display.
OR 3s
3s
Alternatively, press down until you hear a beep. Then press again to
enter the measurement mode. The text “Start” is shown on the display.
8.3 Find the correct measurement position
The forehead support A rests on your forehead and the cheek support B
rests on your cheek.
START 90°
Look straight ahead and the tonometer is at a 90-degree angle to your
face. The probe is about 5 mm (3/16 inches) from your eye and points
perpendicularly to the center of your eye.
18 19
START
<90°
If you see a red light in the probe base, the tonometer is tilted too much
downwards. You should straighten your posture and lift your chin.
8.4 Adjust the supports and position the tonometer
WARNING! Only probes are intended for contacting the eye. Avoid touching the eye with
other parts of the tonometer. Do not push the tonometer into the eye.
WARNING! Shorten the cheek and forehead supports of the tonometer only slightly at a
time to prevent the tonometer from getting too close to your eye.
PRECAUTION! Eye detection is based on the difference of infrared reflections received
from the transmitters: the nose side reflects more than the temple side. If the
transmitters become dirty, the recognition may be interfered.
PRECAUTION! Do not cover the eye recognition transmitters or sensor during the
measurement, for example with your fingers. Keep your hand, hair, and objects such as
pillows away from the temple side of your eye, as they produce an infrared reflection
that causes an error.
1. Before the measurement, adjust the forehead and cheek supports to
the correct length. Start with the supports at the maximum length.
You can take the measurement sitting, standing, or lying down (supine
position).
START
90°
START
START
90°
START 90°
2. Shorten the supports two clicks at a time to prevent the tonometer
from getting too close to your eye.
3. Place the tonometer against your face and look into the probe base.
START
The probe points perpendicularly to the center of your eye when the
blue and green rings in the probe base are symmetrical.
4. If the rings are not symmetrical, the probe does not point
perpendicularly to the center of your eye. Correct the position
of the tonometer.
START
20 21
5. Keep both eyes open. Covering the eye not being tested may help
you see the rings more clearly.
6. Shorten the supports by rotating them clockwise two clicks at a
time until you only see a symmetrical green ring. The tonometer is
now at the correct distance from your eye.
START
5 mm
8.5 Measure your eye pressure
1. Start the measurement when you see only a symmetrical green ring.
Press the Measure button once. The probe gently touches your
eye.
1x
START
2. A single beep indicates a successful measurement. Continue taking
measurements, until you hear a long beep and the light in the probe
base turns off.
3. If the probe base flashes red and you hear multiple beeps,
indicate the source of the error.
Look at the display and press to acknowledge the error. Make
the necessary corrections and repeat the measurement. The errors
and corrective actions are explained in chapter “8.7 Errors during the
measurement”.
4. A measurement sequence consists of six measurements.
6x
NOTE! You can also take the measurement sequence by pressing and holding the Measure
button down until all six measurements have been taken.
5. When all six measurements have been successfully taken, you hear
a longer beep. The light in the probe base turns off, and you see the
result on the display.
The measurement results are explained in chapter “8.8 Check the
measurement result”.
NOTE! If you doubt the validity of a measurement result, for example, if you suspect
that the probe missed the center of your eye or contacted your eyelid, repeat the
measurement.
6. Press and repeat the measurement on your other eye, if needed.
22 23
8.6 Measure your eye pressure in the supine position
Before measuring, lie down (supine position) for a moment.
1. Take a comfortable position on your back with a pillow behind your
neck. Look straight ahead.
Avoid bending your head and neck backwards.
2. Place the tonometer at a 90 degrees angle on your face and take the
measurement as as instructed in 8.5 Measure your eye pressure.
START
NOTE! Before measuring, the forehead and cheek supports may need to be adjusted to be
slightly shorter.
3. After a successful measurement, press the Measure button once.
Repeat the measurement on your other eye.
8.7 Errors during the measurement
Screen Text Sound Description Actions
TOO FAR 3 long
beeps
The measurement
was taken too
far from the eye.
The probe did not
touch the eye.
Press the Measure
button once
to acknowledge
the error. Turn the
supports clockwise
until the probe is
about 5 mm from
your eye and you see
a green light ring.
TOO NEAR 5 short
beeps
The measurement
was taken too
close to the eye.
Press the Measure
button once
to acknowledge
the error. Turn
the supports
counterclockwise until
the probe is about
5 mm from your eye.
INCORRECT
ALIGNMENT
2 short
beeps
The probe was not
perpendicular to
the cornea or the
probe hit an eyelid
or eyelashes.
Press the Measure
button once to
acknowledge the
error. Position the
tonometer so that
the probe points
perpendicularly to
the center of your
eye. Keep your eye
properly open.
REPEAT 2 short
beeps
The probe did not
move properly or
did not make a
clean contact with
the cornea.
Press the Measure
button once to
acknowledge the
error. Measure again
or change the probe.
CHANGE 2 short
beeps
The probe did not
move.
Press the Measure
button once to
acknowledge the
error. Change to a new
probe.
DETECTION
ERROR
2 short
beeps
The eye side could
not be detected
automatically.
Press , then press
until the correct
eye is shown on the
display. Press ,
or press the return
button to cancel the
measurement.
REPEAT 2 short
beeps
The variation in the
measurements was
too high.
Press the Measure
button once to
acknowledge the
error. Repeat the
measurement.
Press to acknowledge the error and to continue measuring.
24 25
8.8 Check the measurement result
After a successful measurement, the measurement result is shown on the
display. The quality of the measurement is indicated with a color:
mmHg
17
Green: good measurement quality
mmHg
17
Yellow: acceptable measurement quality
The variation between the measurements was too high. Repeat the
measurement.
The tonometer stores the calculated eye pressure reading in mmHg, the
time and date of the measurement, which eye was measured and the
quality of the measurement.
The measurement quality is an indication of how much variation there was
between the six individual measurement results. The measurement quality
indication (green or yellow) is not related to the level of eye pressure
8.9 View your previous measurements
1. Press after you have seen the measurement result on the display.
2. Press until you see HISTORY on the display.
3. Press .
4. Press and to view your measurement results. The tonometer shows
the last 100 measurement results.
5. To exit the view, press .
1
4
5
2
3
1–Date and time of the measurement
2–Measured eye
3–Measurement ordinal
4–Horizontal arrow indicates that you were standing or sitting during the
measurement, diagonal arrow indicates tilted position, and vertical arrow
indicates that you were lying down
5–Green result means good measurement quality, yellow means acceptable
quality.
See chapter “12.3 Transfer measurement data to iCare CLINIC or iCare CLOUD”
for advice on how to transfer your measurement results to the iCare CLINIC
or the iCare CLOUD.
9 Switch off the tonometer and dispose of
the probe
To switch off the tonometer, press and hold down until you hear 3 beeps
and the display turns off. The tonometer turns off if you don’t use it for three
minutes.
3s
Remove the probe and put it back to the probe container.
Dispose of the probe and container in a mixed waste bin.
10 Tonometer modes
10.1 Practice mode
If you want to practice with the tonometer before taking a measurement,
use the practice mode. In the practice mode, you take 10 measurements,
and the display shows if a measurement was successful: the blue segments
on the circle are successful measurements and the red ones unsuccessful.
These measurement results are not stored on the tonometer’s memory.
26 27
PRACTICE
MODE START
70%
SUCCESSFUL:
7
ERRORS:
3
ERRORS:
1 TOO FAR
1 TOO NEAR
0ALIGNMENT
1REPEAT
SETTINGS
1. Press and hold down to switch on the tonometer.
2. Press until you see SETTINGS on the display.
3. Press .
4. Press until you see PRACTICE MODE on the display.
5. Press .
6. Insert the probe to the tonometer.
7. Press .
8. Adjust the tonometer to your face and press 10 times.
When the tonometer shows your success rate, press the navigation buttons
to see what kind of errors occurred during the practice measurements.
To measure again, press , or press to return to the settings.
10.2 Rental mode
With the iCare CLINIC software, the healthcare professional can set the
tonometer to the rental mode which allows the healthcare professional to
set a rental time for the tonometer. During the rental time, the patient can
take measurements with the tonometer. Once the rental time expires, the
patient can no longer take measurements with the tonometer.
For instructions on setting the rental mode, see the iCare CLINIC, EXPORT
and PATIENT2 Instruction Manual for Healthcare Professionals.
To see when the rental expires:
1. Press and hold down to switch on the tonometer.
2. Press until you see INFO.
3. Press .
4. Press .
5. To exit the view, press .
RENTAL
EXPIRES
dd.mm.yyyy
hr:min
10.3 Hide mode
With the iCare CLINIC software, the healthcare professional can set the
tonometer to the hide mode which hides the measurement results from
the patient. The quality of the measurement is shown with a green or yellow
color as in the normal mode. The HISTORY view shows all other information
related to measurements, except for the measurement result.
mmHg
LEFT
1
18/09/2017
07:37 AM
mmHg
18/09/2017
07:37 AM
2
RIGHT
mmHg
18/09/2017
07:37 AM
3
RIGHT
RESULT HISTORY
For instructions on setting the hide mode, see the iCare CLINIC, EXPORT and
PATIENT2 Instruction Manual for Healthcare Professionals.
11 Tonometer settings
1. Press and hold down to switch on the tonometer.
2. Press until you see SETTINGS on the display.
3. Press .
4. Press or to move between the various settings.
5. To select a setting, press .
6. To exit the settings, press
PRACTICE
MODE
SETTINGS
BLUETOOTH
OFF
LANGUAGE
ENGLISH
TIME
17:20
DATE
09/05/2019
SOUND LIGHT BRIGHTNESS
11.1 Language settings
1. To change the language, press or until you see LANGUAGE.
2. Press .
3. Press or until you see the language you want, and press .
4. To go back to the settings, press .
11.2 Time settings
1. To change the time, press or until you see TIME.
2. Press .
3. Press or until you see the time format you want, and press .
4. Press or until you see the time zone you want, and press .
5. Press or until you see the hour you want, and press .
6. Press or until you see the minutes you want, and press .
11.3 Date settings
1. To change the date, press or until you see DATE.
28 29
2. Press .
3. Press or until you see the date format you want, and press .
4. Press or until you see the year you want, and press .
5. Press or until you see the month you want, and press .
6. Press or until you see the day you want, and press .
11.4 Volume settings
1. To change the volume level, press press or until you see SOUND.
2. Press .
3. Press or until you hear the volume level you want, and press .
11.5 Probe base light settings
1. To change the brightness of the probe base light, press or until you
see LIGHT.
2. Press .
3. Press or until you see the brightness level you want, and press .
11.6 Display brightness settings
1. To change the brightness of the display, press or until you see
BRIGHTNESS.
2. Press .
3. Press or until you see the brightness level you want, and press .
11.7 Tonometer’s serial number and firmware version
1. Press and hold to switch on the tonometer.
2. Press until you see INFO on the display.
3. Press .
4. To exit the view, press .
NOTE! The serial number is also printed on the label at the back of the tonometer.
12 iCare software system
WARNING! When reading the measurement data in a clinic or hospital environment,
make sure the tonometer and the computer or mobile device which are not medical
equipment are located outside of the patient environment, i.e. 1.5 m (5 feet) from the
patient.
The iCare software system consists of the following:
• iCare HOME2 tonometer
• iCare CLINIC, a browser-based software service with which the healthcare
professionals and patients can view the measurement data
• iCare PATIENT2 mobile application with which the patients and healthcare
professionals can view measurement data and transfer it to the iCare CLINIC
cloud service
• iCare EXPORT computer software with which the patients and healthcare
professionals can view the measurement data and transfer it into the
iCare CLINIC cloud service or iCare CLINIC On-premises
Patients can store their measurement data to a private account in the
iCare CLOUD service, if their tonometer is not registered to a healthcare
professional’s iCare CLINIC account. For information on how to set up a
private account, read the labelling material in the tonometer’s carrying case.
You can transfer data from the tonometer using a USB cable connection or
Bluetooth®.
Note that if you transfer the measurement results using iCare EXPORT, once
you have transferred the results, they will be automatically deleted from the
tonometer’s memory.
For instructions on using the software system, see the iCare CLINIC, EXPORT
and PATIENT2 Instruction Manual for Healthcare Professionals or the iCare
CLINIC, EXPORT and PATIENT2 Instruction Manual for Patients.
START
12.1 Compliancy standards
The mobile device or computer connected to the iCare HOME2 tonometer
within the patient environment must be compliant with IEC 60601-1.
Equipment not complying to IEC 60601-1 must be kept outside the patient
environment and must comply to IEC 60950-1 or IEC 62368-1 or a similar
safety standard.
Any person who connects a mobile device or a computer to the iCare
HOME2 tonometer has formed a Medical Electrical System according to
the definition of IEC 60601-1 and is therefore responsible for the system
to comply with the requirements of IEC 60601-1. If in doubt, contact Icare
Finland.
For more information on the iCare software, go to www.icare-world.com.
The technical specification for the IT network is in chapter “17.3 IT network
specifications”.
12.2 Install the software
• Before the healthcare professional or the patient can start transferring
data from the tonometer to the iCare CLINIC cloud service, the healthcare
professional
needs to subscribe to iCare CLINIC at www.icaremhome.com
.
• To install iCare EXPORT on a computer, download the software from the
Help menu of iCare CLINIC.
30 31
• To install iCare PATIENT2 on a mobile device, open Google Play (for Android)
or App Store (for iOS) on the mobile device and search for iCare PATIENT2.
Follow the installation instructions shown on the display.
For information on how to set up a private account to the iCare CLOUD, read
the Getting started guide in the tonometer’s carrying case. A private account
in iCare CLOUD may be used in case the tonometer is not registered to a
health care professional’s CLINIC account.
12.3 Transfer measurement data to iCare CLINIC or iCare
CLOUD
12.3.1 Use a USB connection
WARNING! Do not connect anything to the tonometer’s USB port but the USB cable
supplied with the tonometer.
WARNING! Keep the USB cable out of the reach of children and pets due to the risk of
strangulation.
WARNING! Do not connect the USB cable to the tonometer’s USB port except when
uploading patient measurement data. Do not take any measurements when the USB
cable is connected.
WARNING! The tonometer’s batteries are not rechargeable. Do not try to charge the
tonometer with USB chargers connected to a mains voltage.
NOTE! If you have an iPhone, you cannot use the USB connection. Use the Bluetooth connection
instead.
USB-C
Micro USB
USB-AUSB-C
1. Open the iCare EXPORT software on your computer, or the iCare
PATIENT2 application on your mobile device.
2. Connect the tonometer to your mobile device or computer with the USB
cable provided in the tonometer’s sales package. If your mobile device
has a micro-USB port, use the adapter provided in the sales box.
3. Follow the instructions shown on your mobile device or computer.
4. After removing the USB cable, put the USB cover on the tonometer’s
USB port.
12.3.2 Use a Bluetooth connection
1. Open the iCare EXPORT software on your computer, or the iCare
PATIENT2 application on your mobile device.
2. Press and hold to switch on the tonometer.
3. Press until you see SETTINGS on the display.
4. Press .
5. Press until you see BLUETOOTH, and press .
6. Press and press .
7. On your mobile device or computer, go to the device list, and select the
tonometer from the drop-down list. Make sure that the serial number of
the tonometer matches with the one at the back of the tonometer.
8. Once the software prompts you for a PIN code, enter the PIN code you
see on the tonometer’s display.
012345
PIN CODE
If you enter a wrong code, the pairing stops and you need to start it
from the beginning.
9. When you see BLUETOOTH CONNECTED on the tonometer display,
press .
10. Follow the instructions shown on your mobile device or computer.
12.4 Bluetooth notifications and errors
Screen Text Description Actions
BLUETOOTH ON Bluetooth is on.
BLUETOOTH OFF Bluetooth is off.
000000
PIN CODE
Bluetooth PIN code for
pairing the tonometer
with iCare EXPORT or
iCare PATIENT2.
Enter the PIN code on
your mobile device or
computer.
32 33
Screen Text Description Actions
BLUETOOTH
CONNECTED
Tonometer is
connected to iCare
EXPORT or iCare
PATIENT2.
Press to
acknowledge the
notification.
PAIRING CANCELLED Pairing stopped. Press to
acknowledge the
notification, and
repeat the pairing
process from the start,
if needed.
BLUETOOTH ERROR PIN code was
incorrect, or iCare
EXPORT or iCare
PATIENT2 removed the
pairing.
Press to
acknowledge the
notification, and
repeat the pairing
process from the start.
13 Troubleshooting
Screen Text Description Actions
CHANGE Batteries are empty. Insert new batteries.
USB connection error. Remove the USB cable
from the tonometer and
connect it again.
BLUETOOTH
ERROR
PIN code was
incorrect, or iCare
EXPORT or iCare
PATIENT2 removed the
pairing.
Press to acknowledge
the notification, and
repeat the pairing process
from the start.
SERVICE ID Internal error. Write down the service
ID shown on the display.
Switch off the tonometer.
Contact the organization
from which you obtained
the tonometer or Icare
Finland to arrange service
for the tonometer. See
chapter “14.4 Return the
tonometer for service or
repair”.
Force shutdown error.
The tonometer displays
the error code (NN) for
3 seconds and shuts
down.
Switch the tonometer
on. If the error occurs
repeatedly, contact
the organization from
which you obtained the
tonometer or Icare Finland
to arrange service for the
tonometer.
Screen Text Description Actions
RENTAL
EXPIRED
Tonometer’s rental
time has expired, and
measuring is disabled.
Return the rented
tonometer to the clinic
or discuss extending your
rental period with the
clinic.
14 Maintenance
WARNING! The tonometer should only be opened by qualified iCare service personnel.
The tonometer does not contain any user-serviceable parts, apart from the batteries and
the probe base. The tonometer does not require any routine servicing or calibration
other than changing the batteries at least annually and the probe base every six months.
If there is a reason to believe that the servicing of the tonometer is necessary, contact
the manufacturer or local distributor.
WARNING! The tonometer must not be repaired or re-assembled by any other than the
manufacturer or its authorized service center. If the tonometer is broken, do not use it.
Take it to an authorized iCare service center for repair.
WARNING! To avoid possible damage, keep the tonometer out of the reach of children
and pets. The probe base, battery cover, screws, collar, and probes are small objects and
may be accidentally swallowed.
WARNING! Do not change the batteries or the probe base when the USB cable is
connected.
WARNING! Servicing or maintenance actions must not be performed while the
tonometer is in use.
14.1 Replace the probe base
WARNING! The tonometer must be switched off when the probe base is changed.
WARNING! The probe base must be changed, not cleaned.
PRECAUTION! To ensure the correct functioning of the tonometer, change the probe
base every six months.
NOTE! Change the probe base if the tonometer constantly prompts REPEAT or CHANGE and
changing the probe does not resolve the issue.
The probe base may function improperly if dirt or liquid gets inside it.
1. Switch off the tonometer.
2. Turn the probe base collar counterclockwise until it becomes loose.
3. Lift the collar off the tonometer.
34 35
To prevent cross-contamination, the healthcare professional must disinfect
the outer surfaces of the tonometer using 70%-100% isopropyl alcohol or
70% ethanol before lending the tonometer to patients. If the tonometer
gets dirty during use, the patient should clean it with a cloth or paper towel
dampened with water.
To clean the applicator, rinse it with clean water and then dry it before use
or wipe it with ethanol or isopropyl alcohol.
14.3 Lifetime
The expected service life of the tonometer is 5 years. The maintenance
procedures described in this manual are required during the expected
service life.
The shelf life of the probes in their intact original packaging is 3 years.
Check the expiry date from the probe package label.
Inspect the tonometer for mechanical and functional damage and the safety
labels for legibility and integrity annually. Contact the manufacturer or local
distributor if you detect any damage or deterioration.
A set of batteries is expected to last over 1000 measurements in normal use.
The performance of the batteries may vary depending on the battery brand
and model.
Applicable in Germany only: Messtechnische Kontrolle nach MPG
(Medizinproduktegesetz) alle 24 Monate.
14.4 Return the tonometer for service or repair
NOTE! Before contacting for service, write down the serial number of your tonometer, the
LOT number of the probe package in use and, if applicable, the service ID number from the
tonometer display.
Contact the organization from which you obtained the tonometer or Icare
Finland’s technical services department (go to www.icare-world.com) for
shipping instructions. Unless otherwise instructed by Icare Finland, there
is no need to ship any accessories with the tonometer. Use a suitable
cardboard or similar box with the appropriate packaging material to protect
the tonometer during shipment. Return the tonometer using any shipping
method that includes a proof of dispatch and delivery.
NOTE! For assistance in setting up, using, or maintaining the tonometer or to report unexpected
operation or events, contact the manufacturer or manufacturer’s representative.
14.5 Recycle
Do not dispose of the tonometer with household waste. Send it to an
appropriate facility for recovery and recycling. The tonometer should
be recycled as electronic waste.
The separate collection and recycling of your product or its battery at the
time of disposal help conserve natural resources and ensure that it is
recycled in a manner that protects human health and the environment.
The sales package and the probe boxes are carton and can be recycled.
Waste carton generally includes paper, carton, and cardboard packages.
Recycle according to local laws and regulations.
Put the probes back to their containers and dispose of as mixed waste.
4. Pull the probe base off.
5. Insert a new probe base into the tonometer.
6. Put the collar back to the tonometer.
7. Turn the collar clockwise until it is firmly in place. Do not use excess
force.
Dispose of the used probe base. To order new probes or probe bases,
contact the organization from which you obtained the tonometer or
Icare Finland.
14.2 Clean and disinfect the tonometer
WARNING! Never immerse the tonometer in liquid. Do not spray, pour, or spill liquid
Immediately remove any liquid from the surface of the tonometer.
WARNING! The probe base must be changed, not cleaned.
PRECAUTION! Certain microbiological agents (for example, bacteria) can be transmitted
from the forehead or cheek support. To prevent this, clean the forehead and cheek
supports with disinfectant for each new patient.
36 37
The plastic probe boxes are of polypropylene. Dispose or recycle
them as plastic according to local laws and regulations.
15 Glossary
• Cornea: the eye’s outermost dome-shaped clear layer
• Expected service life: expected lifetime before replacement
• Forehead/cheek supports: the tonometer’s adjustable supports
• GAT: Goldmann applanation tonometry, the standard eye test that can
detect your eye pressure
• Intraocular pressure: eye pressure
• IOP: intraocular pressure
• mmHg: the unit of measurement for the eye pressure
• Probe: the tonometer’s single-use item that lightly touches your eye
• Probe base: a replaceable part that guides the probe’s movement during
measurements
• Probe base light: colored light rings or a solid light help you place the
tonometer correctly on your face
• Shelf life: the time that the probe remains sterile in its intact packaging
• Supine position: lying on your back with your face upwards
16 Accessories, parts, and other supplies
SKU Product description Weight Dimensions
(height x depth x width)
Accessories
114 Probe iCare TP022, 20 pcs/box 50 g 31 mm x 53 mm x 103 mm
113 Probe iCare TP022, 50 pcs/box 56 g 35 mm x 82 mm x 195 mm
Parts
540 Probe base 4 g 7 mm x 38 mm
559 Wrist strap with lock 4 g 10 mm x 10 mm x 270 mm
551 Probe applicator 6 g 28 mm x 51 mm
Other supplies
7214 Probe base collar, iCare HOME2 2 g 19.5mm x 19.5mm
577F USB manual, iCare HOME2
575B USB cable for PC connection-
Type C male to A male
30 g 1 m
648B USB cable-Type C male to C
male+USB C to B adapter
6 g 20 cm
528 Carrying case for iCare HOME2 310 g 88 mm x 145 mm x 315 mm
548 Screwdriver 15 g 16 mm x 90 mm
17 Technical information
17.1 Technical description
WARNING! Do not modify the tonometer in any way. Changes or modifications not
expressly approved by the manufacturer could void the user’s authority to operate
NOTE! A separate service manual is available for service personnel.
Type: TA023
Dimensions: 50 mm x 94 mm x 152 mm (supports extended to maximum)
Weight: 205 g without batteries, 300 g with batteries
Power supply: 4 x 1.5 V, AA, non-rechargeable batteries, alkaline LR6
Measurement range: 7 – 50 mmHg
Accuracy:
Repeatability (coefficient of variation): <8%
Precision of display: 1 mmHg
Display unit: millimeters of mercury (mmHg)
Operation environment:
Temperature: +10 °C to +35 °C (50 °F to 95 °F)
Relative humidity: 30 % to 90 %
Atmospheric pressure: 800 hPa to 1,060 hPa
Storage environment:
Temperature: -10 °C to +55 °C (14 °F to 131 °F)
Relative humidity: 10 % to 95 %
Atmospheric pressure: 700 hPa to 1,060 hPa
Transport environment:
Temperature: -40 °C to +70 °C (-40 °F to 158 °F)
Relative humidity: 10 % to 95 %
Atmospheric pressure: 500 hPa-1,060 hPa
NOTE! It is recommended to let the tonometer temperature stabilize for about an hour to room
temperature before taking the tonometer to use after transport or storage.
The tonometer and its materials are compliant with RoHS Directive 2011/65/EU.
The tonometer and its parts are not made of natural rubber latex.
Method of sterilization of the probes: gamma-irradiation
Mode of operation: continuous
The serial number is located on the back of the tonometer. The LOT number
of the probes is on the side of the probe box and the blister packing. There
are no electrical connections from the tonometer to the patient. All the parts
of the tonometer are applied parts and the tonometer has BF-type electric
shock protection.
17.2 System requirements for iCare CLINIC
• Internet connection
• Minimum web browser versions: IE 11, Chrome (v 58), Firefox (v 53) and
Safari (5.1.7)
17.2.1 Minimum computer requirements for iCare EXPORT
• x86 or x64 1 GHz Pentium processor or equivalent
• 512 MB RAM
• 512 MB of hard disk space (in addition, 4.5 GB if .NET not already installed)
• USB 2.0 connection
• 800 x 600 resolution display with 256 colors
• DirectX 9 compatible graphics card
• .NET Framework 4.6.1 or greater
• Operating System: Windows 7, Windows 8, or Windows 10
• Internet connection
• Using Bluetooth requires a computer with Windows 10 version 1703 or
newer and Bluetooth BLE card / chip.
17.2.2 Minimum system requirements for iCare PATIENT2
38 39
• Android smart phone or tablet with USB OTG support, operating system
v6.0 or newer or iPhone with operating system iOS 12 or newer
• USB OTG C male – C male cable, supplied with the tonometer
• Internet connection
To verify the required USB OTG support in the smart phone or tablet, use the
OTG? application available on Google Play or another application providing
similar functionality.
17.3 IT network specifications
WARNING! Connection of the tonometer to IT networks including other equipment could
result in previously unidentified risks to patients, operators, or third parties.
WARNING! The responsible organization should identify, analyze, evaluate, and control
any additional risks resulting from the tonometer connected to IT networks including
other equipment.
PRECAUTION! Changes to the IT network could introduce new risks requiring additional
analysis by the responsible organization. The changes include:
• changes in the IT network configuration
• connection of additional items to the IT network
• disconnecting items from the IT network
• update or upgrade of equipment connected to the IT network
To transfer the measurement data from the tonometer to a mobile device
or a computer, the tonometer must be connected via Bluetooth or USB.
The mobile device or computer must be connected to the internet or the
hospital’s IT network. The tonometer can be used as a stand-alone without a
Bluetooth or USB connection. The tonometer is designed in such a way that
network failures do not prevent the tonometer from working normally.
17.4 Intended information flow
The iCare HOME2 tonometer collects measurement data. This data is sent
via Bluetooth or USB connection to a computer (Bluetooth Low Energy, BLE)
which has the iCare EXPORT software installed or to a mobile device with
the iCare PATIENT2 application installed.
iCare EXPORT or iCare PATIENT2 transfers the data into the iCare CLINIC
software. You can access the data online using the iCare CLINIC software
with a web browser.
17.5 Potential hazardous situations resulting from the
failure of the IT network
If the IT network connection is lost during the data transfer, no data is lost
from the tonometer. The measurement data can still be found from the
tonometer memory and transferred once the connection is re-established.
Failure or misconfiguration of the IT network may result in data not being
transferred.
17.6 Required characteristics of the IT network
The responsible organization is strongly recommended to maintain
virus protection up to date on the computers and mobile devices used.
to the used web browsers, computers, and mobile devices when available.
17.7 Performance data
17.7.1 Pre-clinical testing
The iCare HOME2 tonometer is an incremental design to the predicate
tonometer iCare HOME. It features the same underlying rebound technology
with enhanced usability and user interface.
The performance data was obtained from a clinical study performed
according to ANSI Z80.10-2009 and ISO 8612 with the predicate tonometer
iCare HOME. In this extensive (N=376) multi-center clinical trial, iCare HOME
was found to fulfil the performance goals set in ANSI Z80.10-2009.
Results: The mean difference and standard deviation (iCare HOME - GAT)
were -0.53 mmHg and 2.43 mmHg, respectively. All ANSI performance goals
were met as 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.
Safety: No adverse events (including corneal abrasions) were recorded in
this study population.
Group N HOME Reference Difference 95% CI
for Mean
Difference
95% LOA
for Mean
Difference
Outside
± 5 mmHg
Outside
± 7.5 mmHg
Mean (SD) Mean (SD) Mean (SD) n (%) n (%)
Reference: GAT (Mean/Median Measurement)
143 12.44
(3.18)
12.86
(2.17)
-0.84
(2.54)
-0.84,
-0.00
-5.50, 4.65 4 (2.8%) 1 (0.7%)
>16 to <23
mmHg
167 18.26
(2.91)
18.99
(1.78)
-0.73
(2.36)
-1.09,
-0.37
-5.45, 3.99 7 (4.2%) 0 (0.0%)
66 26.18
(5.52)
26.41
(4.86)
-0.23
(2.39)
-0.81,
-0.36
-5.00, 4.55 1 (1.5%) 0 (0.0%)
Overall 376 17.44
(6.01)
17.96
(5.50)
-0.53
(2.43)
-0.77,
-0.28
-5.39, 4.34 12 (3.2%) 1 (0.3%)
Accuracy and repeatability of the iCare HOME2 tonometer was assessed in
a bench test. The test was done by measuring a manometrically controlled
artificial cornea. The test pressures (7, 10, 20, 30, 40, and 50 mmHg) covered
the specified measurement range of the iCare HOME2 tonometer. To assess
the accuracy and repeatability, 20 measurements were performed with three
iCare HOME2 tonometers at three different measurement angles (the probe
pointing at the artificial cornea at 0, 45, and 90 degrees to the horizontal).
Same measurements were repeated with three different iCare IC200
tonometers. This resulted in 180 measurements with each tonometer type
Results: The iCare HOME2 tonometer demonstrated a high agreement with
the manometric pressure as with the reference tonometer IC200, regardless
of the pressure level or the measurement angle. The maximum difference
with respect to the manometric pressure was observed at a 30 mmHg
pressure level (+1.3 mmHg) and the maximum difference with respect to
(+0.21 mmHg).
The iCare HOME2 tonometer fulfilled the accuracy and repeatability
coefficient of variation less than 8%.
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