I-care HOME User manual

Icare HOME tonometer Instruction manual for health care professionals ENGLISH
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INSTRUCTION
MANUAL
FOR HEALTH CARE
PROFESSIONALS
ENGLISH

Icare®HOME (Model: TA022) INSTRUCTION MANUAL TA022-036 EN-3.2
Icare®HOME (Model: TA022) INSTRUCTION MANUAL TA022-036 USA-2.0
The information in this document is subject to change without prior notice.
In a conict situation the English version prevails.
This device complies with:
Medical Device Directive 93/42/EEC
Canadian Medical Device Regulations
Copyright © 2017 Icare Finland Oy, Made in Finland
0044
TABLE OF CONTENTS
1. Safety instructions ............................................................................................ 3
2. Indications for use............................................................................................. 6
3. Contradictions ................................................................................................... 6
4. Warning .............................................................................................................. 6
5. Precaution .......................................................................................................... 6
6. Introduction ....................................................................................................... 7
7. Package contents .............................................................................................. 7
8. Before you start................................................................................................. 6
9. Setting up the tonometer................................................................................. 9
9.1 Installing or changing the battery ....................................................................9
9.2 Turning the tonometer on ...............................................................................9
9.3 Loading the probe............................................................................................10
10. Using the tonometer....................................................................................... 12
10.1 Choosing the measurement mode................................................................12
10.2 Adjusting the measurement position............................................................13
10.3 Automatic eye recognition..............................................................................14
10.4 Taking the measurements ..............................................................................15
11. Reading the measurement data.................................................................... 17
12. Troubleshooting............................................................................................... 18
14. Cleaning the probe base ................................................................................. 20
15. Cleaning the disinfection................................................................................ 20
16. Accessories ....................................................................................................... 21
17. Lifetime ............................................................................................................ 21
18. Technical and performance data................................................................... 21
18.1 Clinical performance data...............................................................................22
19. Symbols ............................................................................................................ 29
20. Electromagnetic declaration.......................................................................... 30
Appendix 1. Icare home tonometer training procedures for certication of
health care providers (HCP) ............................................................ 34
Appendix 2. Icare home tonometer training procedures for certication of
the patient for self-use .................................................................... 38
Icare Finland Oy
Äyritie 22, FI-01510 Vantaa, Finland
Tel. [phone], Fax [phone]
www.icaretonometer.com, info@icarenland.com
Icare HOME tonometer Instruction manual for health care professionals ENGLISH
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1. SAFETY INSTRUCTIONS
WARNING!
Do not push the tonometer 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 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 floor.
WARNING!
The Icare HOME Tonometer is indicated for use only under supervision of a health care
professional.
WARNING!
Patients must be certified and trained for the procedures described in this manual
prior to the device being prescribed for home use.
WARNING!
Health care professionals must inform patients not to modify or discontinue their
treatment plan without receiving instructions from the health care professional.
WARNING!
For cybersecurity do not connect to the USB port except when uploading patient
measurement data using the Icare LINK software or when upgrading the HOME TA022
software using the Icare LINK software. Also the tonometer does not allow you to take
any measurements when the USB is connected. All other traditional cybersecurity
controls (anti-virus software, malware software, separate network for the device, etc.)
do not apply since the device is stand alone, is not networked, and does not contain
operating system software.
WARNING!
Do not change the batteries or probe base when the USB cable is connected.
WARNING!
No modification of this equipment is allowed.
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Icare HOME tonometer Instruction manual for health care professionals
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Icare HOME tonometer Instruction manual for health care professionals
Icare HOME 4
WARNING!
Federal (US) law restricts this device to sale by or on the order of a physician or properly
licensed practitioner.
WARNING!
Use only the original and certified probes made by the manufacturer. The probes are for
single-use (one per testing session only). Each testing session is defined by one successful
measurement in both eyes (or only one eye measurement if indicated). 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
effectiveness of the tonometer.
WARNING!
The probe should be replaced if it contacts or is suspected of having contacted the
eyelashes or eyelid such as might occur during a blink.
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!
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.
PRECAUTION!
•The patient should be instructed to thoroughly wash and dry their hands with soap
and a clean towel prior to handling the probe.
•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 flammable substances, including flammable
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’.
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Icare HOME
PRECAUTION!
•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 bin for metal waste).
•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 fingers. Keep your hand, hair etc. and objects such as pillows away from the temple side of
your eye, as they produce an infrared reflection that causes an error.
•The tonometer turns off automatically after 3 minutes if it is not used.
•Do not carry out any other service procedures than those described in the chapters 10-12. Leave
all other service and repairs to the manufacturer or a certified 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.
•Icare HOME tonometer is not intended for routine clinical use.
•As the Icare HOME is intended to acquire serial measurements of intraocular pressure over an
extended period of time, individual IOP measurements are not to be considered separate from
their associated IOP curves. This IOP 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.
•Bench testing of the Icare HOME tonometer on model eyes showed that there was no impact on
probe function and performance with 30 repeated uses within a single testing session. The
impact on probe function and performance when the probe is repeatedly used over 30 times is
unknown.
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Icare HOME tonometer Instruction manual for health care professionals
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Icare HOME
PRECAUTION!
•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 bin for metal waste).
•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 fingers. Keep your hand, hair etc. and objects such as pillows away from the temple side of
your eye, as they produce an infrared reflection that causes an error.
•The tonometer turns off automatically after 3 minutes if it is not used.
•Do not carry out any other service procedures than those described in the chapters 10-12. Leave
all other service and repairs to the manufacturer or a certified 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.
•Icare HOME tonometer is not intended for routine clinical use.
•As the Icare HOME is intended to acquire serial measurements of intraocular pressure over an
extended period of time, individual IOP measurements are not to be considered separate from
their associated IOP curves. This IOP 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.
•Bench testing of the Icare HOME tonometer on model eyes showed that there was no impact on
probe function and performance with 30 repeated uses within a single testing session. The
impact on probe function and performance when the probe is repeatedly used over 30 times is
unknown.
English
Icare HOME tonometer Instruction manual for health care professionals
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Icare HOME tonometer Instruction manual for health care professionals
2. INDICATIONS FOR USE
The Icare HOME tonometer is a prescription device intended as an adjunct to the
routine clinical monitoring of intraocular pressure (IOP) of adult patients.
3. CONTRAINDICATIONS
Patients with any of the following conditions should not be prescribed the HOME
tonometer:
1) Active ocular infection including infectious conjunctivitis
2) Recent ocular trauma including corneal laceration or corneal/scleral
perforation
3) Inability to demonstrate proficiency with Icare Home tonometer after
training and failure to complete certification procedures. Patients for whom
initial agreement between GAT and HOME measurements in the clinic is
poor should not be prescribed the Icare HOME device for home use.
4) Disabling arthritis or limited motor coordination affecting self-handling of
the Icare tonometer
5) Blepharospasm
6) Nystagmus
4. WARNING
Patients with the following conditions are generally not eligible for use of the HOME
tonometer as they have the potential to introduce unsafe conditions during use or
to impair measurement acquisition:
1) Uncorrected near visual acuity of 20/200 or worse
2) Only one functional eye
3) Poor or eccentric fixation
4) Hearing impairment to the extent that the individual cannot hear and
converse with others without an assistive aid and/or sign language
5) Contact lens use
6) Dry eyes
7) Keratoconus
8) Microphthalmos
9) Buphthalmos
10)
Icare HOME
Cataract extraction within last 2 months
5. PRECAUTION
The safety and effectiveness of the Icare HOME tonometer has not been evaluated for
patients with:
1) High corneal astigmatism >3d
2) History of prior incisional glaucoma surgery or corneal surgery including corneal
laser surgery
3) Corneal scarring
4) Central corneal thickness greater than 0.60mm or less than 0.50mm
5) Known history of difficulty in obtaining Goldmann IOP measurements or any
factors that might contribute to inaccurate Goldmann IOP measurements (e.g. lid
squeezing or tremor)
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Icare HOME
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Icare HOME tonometer Instruction manual for health care professionals
6. INTRODUCTION
The Icare HOME tonometer is a hand-held device for self-use.
The tonometer uses the rebound method. A small and light single-use probe makes
contact with the eye very briefly. 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 final IOP and stores it with other
information in the tonometer’s memory, including date, time, eye identification
(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.
7.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.
PRECAUTION!
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
• Patient guide
• Support position tags
• Warranty card
• Carrying case
•Wrist strap
•Probe base cleaning container
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Icare HOME
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. Silicone 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.
Icare HOME tonometer Instruction manual for health care professionals
8. BEFORE YOU START
Find the main parts, buttons and indicator lights of the tonometer in the below gures.
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PRECAUTION!
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 silicone lid that protects the USB port and
keeps the battery compartment cover in place. Open
the battery compartment cover by pressing the
silicone lid slightly and sliding the battery
compartment cover as shown in the figure left.
1. Siliconelid
2. Battery cover
Insert two CR123A lithium batteries in the correct
order: (+) end upwards as shown in the figure left.
Close the cover firmly and press the silicone lid in
place to cover the USB port.
9.2 TURNING THE TONOMETER ON
PRECAUTION!
The tonometer turns o automatically after 3 minutes if it is not used.
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.
English
Opening the silicone lid and battery cover
Inserting new batteries
1.
2.
2 x CR123A
Icare HOME tonometer Instruction manual for health care professionals
9. SETTING UP THE TONOMETER
Setting up your Icare HOME tonometer is easy, with few steps. The following
subchapters describe how you get started.
9.1 INSTALLING OR CHANGING THE BATTERY
Icare HOME
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Icare HOME
PRECAUTION!
The patient should be instructed to thoroughly wash and dry their hands with soap and a
clean towel prior to handling 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 floor.
WARNING!
Use only the original and certified probes made by the manufacturer. The probes are for
single-use (one per testing session only). Each testing session is defined by one successful
measurement in both eyes (or only one eye measurement if indicated). 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
effectiveness of the tonometer.
The Icare HOME tonometer uses single-use probes that are packed in a plastic
tube (container) and wrapped in blister packs as shown in the figures below.
After using the tonometer to measure IOP, the user can remove the probe
either by powering off the device and allowing the probe to slide out of the
probe base or by pulling the probe out of the probe base. The probe can be
discarded by placing the probe back in its container and disposing of it properly.
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Icare HOME tonometer Instruction manual for health care professionals
9.3 LOADING THE PROBE
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