instruction manual
ENGLISH
INSTRUCTION MANUAL
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Icare tonometer PRO manual
English
Icare® PRO (Model: TA03) INSTRUCTION MANUAL v2.0 09/13 EN
TABLE OF CONTENTS
1. Safety instructions .................................................................................................................... 4
2. Indications for use .................................................................................................................... 5
3. Introduction ............................................................................................................................... 6
4. Package contents ...................................................................................................................... 6
5. Before using .............................................................................................................................. 7
6. Setting up the tonometer before taking measurements ...................................................... 8
6.1 Turning the tonometer ON ......................................................................................... 8
6.2 Navigating ..................................................................................................................... 8
6.3 Loading the probe ....................................................................................................... 8
6.4 Adjusting the measurement position ........................................................................ 9
7. Measuring intraocular pressure (IOP)................................................................................... 10
7.1 Results......................................................................................................................... 11
7.2 Settings ....................................................................................................................... 12
7.3 Measurement history ................................................................................................ 13
8. Trouble shooting ..................................................................................................................... 13
9. Replacing the probe base ...................................................................................................... 15
10. Cleaning the probe base ...................................................................................................... 15
11. Cleaning the tonometer ....................................................................................................... 15
12. Periodic safety checks .......................................................................................................... 16
13. Maintenance .......................................................................................................................... 16
14. Charging the battery ............................................................................................................. 17
15. Accessories, consumables and spare parts ....................................................................... 18
16. Technical and performance data ........................................................................................ 18
17. Clinical performance data .................................................................................................... 19
18. Symbols ................................................................................................................................. 20
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Icare tonometer PRO instruction manual
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0044
This device complies with:
Medical Device Directive 93/42/EEC
Canadian Medical Device Regulations
Copyright © 2013 Icare Finland Oy
Made in Finland
Icare Finland Oy
Äyritie 22, FI-01510 Vantaa, Finland
Tel. +358 9 8775 1150, Fax +358 9 728 6670
www.icaretonometer.com, info@icarefinland.com
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Icare tonometer PRO instruction manual
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1. SAFETY INSTRUCTIONS
WARNING!
Federal (US) law restricts this device for sale by or on the order of a physician or properly
licensed practitioner.
WARNING!
Do not bring the tonometer into contact with the eye or push it into the eye (the tip of the probe
should be 3–7 mm, or 1/8 – 9/32 inch, from the eye).
WARNING!
Do not touch the probe directly to prevent contamination.
WARNING!
Never spray, pour or spill liquid onto the Icare tonometer, its accessories, connectors, switches
or openings in the chassis. Do not leave the surface of the tonometer wet.
WARNING!
Do not connect the USB cable during measurement.
WARNING!
Do not change the probe base when the USB cable is connected.
WARNING!
The probes are for single use only. Use probes taken only from original intact packaging. The
manufacturer cannot guarantee sterility of the probe once the seal is compromised. Resterilization or re-use of the probe could result in incorrect measurement values or in the
breakdown of the probe and will void all responsibilities and liabilities of Icare Finland Oy
related to safety and effectiveness of the device.
WARNING!
Do not touch the USB cable terminal and patient simultaneously.
WARNING!
When using a PC to charge your Icare PRO keep both the PC and Icare PRO 1.5m/5 ft. or more
from the patient.
WARNING!
No modification of this equipment is allowed.
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WARNING!
The probe base, screws, collar and probes are so small that a child could swallow them. Keep
the tonometer out of the reach of children.
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 manufacturer or distributor.
 Use the tonometer only for measuring intraocular pressure. Any other use is improper
and the manufacturer is not responsible for any damage arising from improper use, or
for the consequences thereof.
 Never open the casing of the tonometer except for to change the probe base.
 Do not use the device near inflammable substances, including inflammable anesthetics.
 Certain microbiological agents (for example, bacteria) can be transmitted from the
forehead support. To avoid this, clean the forehead support for each new patient with
disinfectant, see the chapter ‘Cleaning the tonometer’.
 The tonometer conforms to EMC requirements (IEC 60601-1-2), but interference may
occur if used near (<1m) a device (such as a cellular phone) causing high-intensity
electromagnetic emissions. 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.
 Be sure to dispose of the single-use probes properly (for example, in a container for
disposable needles), because they may contain microorganisms from the patient.
 Dispose of the device, components and accessories according to applicable local
regulations.
 The tonometer turns off automatically after 3 minutes if you do not use it.
2. INDICATIONS FOR USE
WARNING!
The safety and effectiveness of the Icare PRO tonometer has not been evaluated for
patients with:
•
•
•
•
•
•
Only one functional eye.
Poor or eccentric fixation in one eye.
High corneal astigmatism (i.e. those eyes displaying an oval contact image with
the Goldmann tonometer).
Corneal scarring.
History of prior incisional glaucoma surgery or corneal surgery, including corneal
laser surgery.
Microphthalmos.
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Icare tonometer PRO instruction manual
•
•
•
•
•
•
•
•
English
Buphthalmos.
Contact lenses.
Dry eyes.
Squeezed lids (blepharospasm).
Nystagmus.
Keratoconus.
Any other corneal or conjunctival pathology or infection.
Central corneal thickness greater than 0,600 mm or less than 0,500 mm
The Icare PRO tonometer is a prescription device intended for measuring of
intraocular pressure (IOP) in the human eye. It is indicated for use by health care
professional.
3. INTRODUCTION
The Icare PRO tonometer is a hand-held device that uses a small and light single-use
probe that makes contact with the eye very briefly, so that there is no need for a topical
anesthetic.
The Icare PRO tonometer allows you to measure supine patients and patients in normal
upright (sitting/standing) position.
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 to the
tonometer’s memory including date, time, eye identification (right or left) and
measurement quality.
The Icare PRO tonometer records and displays over one thousand measurement results,
their time and date as well as the quality information of the measurement. You can copy
the recorded measurement information to a PC through a USB cable.
4. PACKAGE CONTENTS
WARNING!
The probe base, screws, collar and probes are so small that a child could swallow them. Keep
the tonometer out of the reach of children.
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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 manufacturer or distributor.
The package contains:
 Icare PRO tonometer
 USB cable for connecting to a PC with Icare LINK software
 Icare LINK software on a USB memory stick
 Table stand for holding Icare PRO in rest on a table and protecting the probe base
from dust
 USB charger
 Additional probe base with a probe holder
 100 sterilized single use probes in a box
 Instruction manual in the USB memory stick
 Warranty certificate
 Instructions for downloading LINK software and registration of the device
 Aluminum case
5. BEFORE USING
Read this manual carefully before starting to use the tonometer. Find the main parts and
buttons of the tonometer in the picture below.
1. Forehead support
adjustment wheel
2. Forehead support
3. Collar
4. Probe base
5. Navigation buttons: Up,
Down, Left and Right
6. Display
7. Main button
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6. SETTING UP THE TONOMETER BEFORE TAKING
MEASUREMENTS
Before taking measurements your tonometer must be set up correctly. Set-up includes:
 Turning the tonometer on
 Loading the probe
 Adjusting the measurement position
6.1 TURNING THE TONOMETER ON
Main menu
Press the main button (7) to turn the tonometer on. The
tonometer will show a welcome screen followed by the
menu. The menu has four items:
 Measure
 History
 Settings
 Turn off
6.2 NAVIGATING
There are navigation buttons (5) and a main button (7) for navigation through the menus
in the tonometer. Each navigation button has a light that turns on when the navigation
button is active for use. Use the left navigation button to go back to the previous menu
when there is no ‘Back to menu’ item in the menu.
6.3 LOADING THE PROBE
WARNING!
Do not touch the probe directly to prevent contamination.
The Icare PRO tonometer uses single use tonometer probes.
Probes are in blister packs as shown in the figure on the right.
To load the probe:
1. Go to Measure and press the main button.
An ‘Insert new probe’-message displays.
2. Partially open the probe blister pack.
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3. Insert the probe into the tonometer from the partially
opened pack without touching the probe.
4. While keeping the probe with its partially opened pack
between your index finger and thumb, lightly press the
probe into the probe base until you feel it stops and locks.
Be careful not to bend the probe. To check probe is
correctly inserted tilt unit backward and forward.
5. Go to Measure and press the main button (7) once to activate the inserted probe.
During activation the device magnetizes the probe (the probe moves rapidly back
and forth). Once you activate the probe, the tonometer is ready for measurements.
6.4 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 3–7 mm, or 1/8 – 9/32 inch, from the eye).
NOTE!
The tonometer turns off automatically after 3 minutes if you do not use it.
The Icare PRO tonometer allows measurements on supine patients as well as patients in
normal upright (sitting/standing) position.
To adjust the position:
1. Ask the patient to look straight ahead with both eyes
open and the chin horizontal.
2. Keep the probe as perpendicular to the center of the cornea
as possible to ensure correct measurements.
3. The device indicates by an error message if you need to
correct the position of the patient.
4. The tonometer has an adjustable forehead support to
ensure accurate measurement distance and alignment.
Adjust the forehead support using the adjustment wheel,
so the distance from the tip of the probe to the surface of
the cornea is 3-7mm (1/8 – 9/32 inch).
5. The probe does not drop when measuring a supine patient
because the tonometer holds the probe in place. Also,
when measuring a supine patient, an arrow appears in the
display indicating the position of the probe is vertical
enough for a successful measurement.
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7. MEASURING INTRAOCULAR PRESSURE (IOP)
A measurement sequence is a series of six measurements.
NOTE!
Anesthetic is not required when performing measurements.
NOTE!
The tonometer turns off automatically after 3 minutes if you do not use it.
To measure intraocular pressure:
1. Check that the tonometer is set up correctly.
2. Go to Menu –> Measure and press the main
button. Select the eye you want to measure
using the left and right navigation buttons and
press the main button to confirm.
3. Tell the patient to relax and look straight ahead at a specific point while keeping
eyes wide open.
4. Bring the tonometer near the eye. The distance from the
tip of the probe to the cornea must be 3-7mm (1/8 – 9/32
inch) as shown in the figure on the right. If necessary, adjust
the distance using the forehead support. Keep the probe
perpendicular to the center of the cornea.
5. Press the main button lightly to perform one individual
measurement, taking care not to shake the tonometer. The
tip of the probe should make contact with the central cornea.
A short beep sounds after each measurement and the device displays a reading.
6. Repeat step 5 six times. Once the six measurements are complete, the device
displays the final IOP reading.
7. Press the main button.
8. Choose YES to continue measuring the other eye of the same patient. Select the
eye you want to measure with the navigation button and the press the main button
(OD/OS).
9. If you do not want to continue measuring, choose NO. You can turn off the device
from the main menu or leave it idle.
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7.1 RESULTS
The device displays the reading after each measurement
within the series of six as an average of the
measurements taken until then. The reading shown after
the sixth measurement is an average of four readings
calculated after discarding the highest and lowest
reading.
The device displays a color and a text indication of the reliability of the IOP reading. If
deviation between the measurements is within normal limits the color is green and the
text goes ‘Deviation: OK’. When deviation is slightly high, the reliability indication color is
yellow and the text goes ‘Deviation: DEVIATION’. When deviation is high, the color is red
and the text goes ‘Deviation: REMEASURE’. The below table explains each indication of
reliability.
DISPLAYED
TEXT
DISPLAYED DEVIATION DESCRIPTION
COLOR
ACTION
Deviation: OK.
Green.
-
Deviation:
DEVIATION.
Yellow.
Deviation:
REMEASURE.
Red.
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< 15 % of
the IOP.
15-25 % of
the IOP.
>25 % of
the IOP.
No or insignificant
deviation.
Slight deviation; the
effect of the
deviation is unlikely
to be relevant to the
result unless the
IOP is 19 or higher.
Deviation is too big.
If the IOP is 19 or
higher, take a new
measurement.
Take a new
measurement.
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7.2 SETTINGS
Use the Settings menu to change the tonometer’s settings.
To access settings, go to Menu –> Settings and press the main
button to confirm.
Brightness - Change the display brightness
Increase or decrease brightness using the up/down navigation
buttons and press the main button to confirm.
Volume - Turn the tonometer sounds on or off
Select on or off using the left/right navigation buttons and press the
main button to confirm. If the sound is off you do not hear the
beep.
Date - Set the date
1. Select the month/day/year you want to change using the
left/right navigation buttons.
2. Change month/day/year using the up/down navigation buttons.
3. Press the main button to confirm.
Time - Set the time
1. Select the hour/minute/second you want to change using the
left/right navigation buttons.
2. Change hour/minute/second using the up/down navigation
buttons.
3. Press the main button to confirm.
About – Shows the serial number of and software version in your
Icare PRO tonometer.
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7.3 MEASUREMENT HISTORY
History contains the results of previous measurements.
To access measurement history:
1. Go to Menu –> History and press the main button to confirm. You will
see the most recent measurement.
2. View previous/next measurements using the up/down navigation
buttons.
3. Press left/right/main button to return to the menu.
8. TROUBLE SHOOTING
The tonometer automatically monitors and controls the measurement position and speed
of the probe during the measurements, and indicates errors with messages and signals.
The following table instructs you in error situations.
Error message
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Error signal
Two short
beeps.
Reason
The probe did not make a clean
contact with the cornea,
because the probe hit an eyelid
or eyelashes.
Two short
beeps.
Distance between the probe
and the cornea was too great or
the probe did not hit the cornea
at all.
Two short
beeps.
Distance between the probe
and the cornea was too short.
Two short
beeps.
The tonometer was tilted too
much.
Action
Ensure the eye is
open, press the
main button to clear
the message and
measure again.
Ensure the distance
is 3-7 mm, press the
main button to clear
the message and
measure again.
Ensure the distance
is 3-7 mm, press the
main button to clear
the message and
measure again.
Position the probe
perpendicular to the
center of the
cornea, press the
main button to clear
the message and
measure again.
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Icare tonometer PRO instruction manual
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Two short
beeps.
The probe did not move
correctly or did not move at all,
because the probe and/or
probe base is dirty, bent or
twisted.
Two short
beeps.
The battery is low.
Two short
beeps.
The probe is continuously not
moving smoothly or stops
moving, because the probe
and/or probe base is dirty, bent
or twisted.
English
Check that the
probe and probe
base are intact.
Press the main
button to clear the
message and
measure again. If
the error repeats,
follow the
instructions of the
sections 9 and 10.
Re-charge.
Follow the
instructions of the
sections 9, press the
main button to clear
the message and
measure again.
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9. REPLACING THE PROBE BASE
Replace the probe base with the probe holder every 6 months. Replace or clean the probe
base if the tonometer displays the probe base error ‘Probe didn’t move properly’.
Replacement instruction for the probe base with the probe holder:
• Turn off the tonometer.
• Unscrew the probe base collar and put it in a safe place.
• Remove the probe base and the probe holder by tilting the tonometer downwards and
pull the probe base and the probe holder out of the tonometer with your fingers.
• Insert a new probe base and probe holder into the tonometer.
• Screw the collar back in, to lock the probe base.
10. CLEANING THE PROBE BASE
You can reuse the probe base after careful cleaning. Clean the probe base every 3
months. Clean or replace the probe base if the tonometer displays the probe base error
‘Probe didn’t move properly’.
Cleaning instruction for the probe base:
• Turn the power off.
• Unscrew the probe base collar and remove the probe base with the probe base holder
from the tonometer.
• Carefully remove the probe holder from the probe base.
• Keep the probe base separately outside of the tonometer.
• Carefully inject isopropyl alcohol through the inside of the probe base for instance by a
pipette or a syringe.
• Dry the probe base by blowing some clean canned or compressed air into the probe
base.
• Carefully insert the probe holder to the completely dry probe base.
• Carefully insert the probe base with the probe holder to the tonometer.
• Screw the collar back.
11. CLEANING THE TONOMETER
WARNING!
Never spray, pour or spill liquid onto the Icare tonometer, its accessories, connectors, switches
or openings in the chassis. Do not leave the surface of the tonometer wet.
Icare PRO’s surfaces have been tested and found chemically resistant to the following
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liquids:
• 100 % 2-propanol
• Mild soap solution
• 95% Pursept solution
Cleaning Instructions for surfaces:
• Turn the power off.
• Dampen a soft cloth with one of the liquids mentioned above.
• Lightly wipe the surfaces of the tonometer with the soft cloth.
• Dry the surfaces with a dry soft cloth.
12. PERIODIC SAFETY CHECKS
We recommend that you inspect the device for mechanical and functional damage and
the safety labels for legibility annually/every 12 months.
13. MAINTENANCE
Only the manufacturer or a certified service center can carry out any service and repairs
other than those above. Before sending the device for service, make sure you have stored
your measurement data to a PC using LINK software.
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14. CHARGING THE BATTERY
When the battery is low, an error message indicates that you must recharge the battery. A
full charge takes approximately one hour. When a green light is blinking in the upper
navigation button, the tonometer is charging. When the green light is constant, charging is
complete. There are four alternative ways to charge the battery:
1.
Connect the USB cable between Icare
PRO and the charger. Select and attach a
suitable plug from the alternatives to the
charger. Connect the charger to the
mains. When charging is complete,
disconnect the charger from the mains.
3.
If you have the optional docking station,
connect the USB cable between the USB
charger and the docking station. Place
Icare PRO to the docking station. Connect
the charger to the mains. When charging
is complete, disconnect the charger from
the mains.
4.
Turn on a PC that has Icare LINK software
installed and running. Keep the PC and
Icare PRO 1.5 m or more away from the
patient. Connect the USB cable between
Icare PRO and the PC to charge from the
PC.
2.
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Turn on a PC that has Icare LINK software
installed and running. Connect the USB
cable between the optional docking
station and the PC. Keep the PC and Icare
PRO 1.5 m or more away from the
patient. Place Icare PRO to the docking
station to start charging from the PC.
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15. ACCESSORIES, CONSUMABLES AND SPARE PARTS



Docking station
Icare PRO probes, 100 pieces per package
Probe base kit (includes probe base and probe holder)
16. TECHNICAL AND PERFORMANCE DATA
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Type designation TA03
The device conforms to CE regulations
Dimensions: 225 mm x 46 mm x 90 mm (8.9’’ x 1.8’’ x 3.5‘’)
Weight: 275 g (9.7 oz.)
Power supply: rechargeable Lithium Ion battery. Up to 1000 measurements can be
taken with a fully charged battery.
Measurement range: 5-50 mmHg
Display range: 1-99.9 mmHg
Accuracy: ± 1.2 mmHg (<20 mmHg) and ± 2.2 mmHg (>20 mmHg)
Repeatability (coefficient of variation): <8%
Accuracy of display: 0.1 mmHg
Display unit: mmHg
The serial number can be shown on the screen (Settings/About)
There are no electrical connections from the tonometer to the patient
The device has BF-type electric shock protection
Charger input 100-240 V ~50/60 Hz 300 mA, Output 5.0 V=1200 mA
Operation environment:
Temperature: +10 °C to +35 °C
Relative humidity: 30 % to 90 %
Atmospheric pressure: 800 hPa – 1060 hPa
Storage environment:
Temperature: -10 °C to +55 °C
Relative humidity: 10 % to 95 %
Atmospheric pressure: 700 hPa – 1060 hPa
Transport environment:
Temperature: -40 °C to +70 °C
Relative humidity: 10 % to 95 %
Atmospheric pressure: 500 hPa – 1060 hPa
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17. CLINICAL PERFORMANCE DATA
Performance data was obtained from a clinical study, performed according to ISO 8612
standard for tonometers. The estimate of the effect of the reference tonometer on the
Icare PRO tonometer value is close to one; the coefficient of determination is R2 = 0.890.
The mean of paired difference (Goldmann-Icare PRO tonometer) was 0.0 (≤16 mmHg 0.4;
>16<23 -0.4; ≥23 -0.3) and standard deviation was 2.7.
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18. SYMBOLS
See operating
instructions for more
information.
Manufacturing date
BF-type device
Sterilized using
irradiation
Single-use disposable
Stand by
Serial number
Do not dispose of in
household waste.
Use by <date>
Manufacturer
Keep dry
Warning
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Lot number
20
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