Keeler Tonocare User manual

Tonometer
INSTRUCTIONS FOR USE
EN JA VI

EN
JA
VI
TonoCare
取扱説明書................................................................... 32
TonoCare
Instructions For Use.......................................................... 1
TonoCare
Hướng dẫn Sử dụng................................................... 63

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TonoCare by KEELER
CONTENTS
1. INDICATIONS FOR USE ................................................................................................... 5
1.1 INTENDED USE / PRINCIPLE OF OPERATION............................................................................ 5
2. SAFETY.................................................................................................................................. 5
2.1 PHOTOTOXICITY .................................................................................................................................... 5
2.2 WARNINGS AND CAUTIONS............................................................................................................ 6
2.3 CONTRAINDICATION........................................................................................................................... 8
3. CLEANING INSTRUCTIONS ............................................................................................. 8
3.1 CLEAN THE PUFF TUBE LENS WEEKLY: ........................................................................................ 8
3.2 CLEAN THE HAND UNIT DAILY AND BETWEEN PATIENTS ................................................. 9
4. INSTALLATION .................................................................................................................... 9
4.1 TOOLS REQUIRED................................................................................................................................... 9
4.2 PACKAGING CONTENT ...................................................................................................................... 9
4.3 TABLETOP INSTALLATION.................................................................................................................10
4.4 WALL MOUNT INSTALLATION .........................................................................................................10
5. USING THE TONOCARE.................................................................................................... 11
5.1 CONTROLS AND INDICATORS........................................................................................................11
5.2 MENU MAP................................................................................................................................................13
6. MEASUREMENT PROCEDURE ........................................................................................14
6.1 ROUTINE CHECKS AND FUNCTIONAL TESTS.........................................................................14
6.2 PREPARING THE DEVICE....................................................................................................................15
6.3 PREPARING THE PATIENT..................................................................................................................15
6.4 TAKING THE READING........................................................................................................................15
6.5 CCT CORRECTION............................................................................................................................... 17
7. PRINTING............................................................................................................................. 19
8. REPLACING THE PRINTER PAPER ................................................................................. 19
8.1 CHARGING YOUR TONOCARE.....................................................................................................20
9. MAINTENANCE ................................................................................................................. 20
9.1 FAULT CODES .........................................................................................................................................21
10. WARRANTY ........................................................................................................................ 21
11. SPECIFICATIONS AND ELECTRICAL RATINGS ........................................................ 22
11.1 ELECTROMAGNETIC EMISSIONS .................................................................................................22
11.2 ELECTROMAGNETIC IMMUNITY...................................................................................................22
11.3 RECOMMENDED SAFE DISTANCES ............................................................................................24
12. TECHNICAL SPECIFICATIONS......................................................................................25
13. ACCESSORIES AND SPARES ........................................................................................ 27
14. PACKAGING AND DISPOSAL INFORMATION .......................................................... 27

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TonoCare by KEELER
15. APPENDIX...........................................................................................................................28
15.1 REPEATABILITY AND REPRODUCIBILITY....................................................................................28
15.2 CLINICAL PERFORMANCE DATA..................................................................................................28

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TonoCare by KEELER
Consult instructions for use General warning sign
Date of manufacture Warning: Non-ionizing radiation
Manufacturer’s name and
address Warning: Electricity
Country of manufacture Warning: Optical radiation
Waste Electrical and Electronic
Equipment (WEEE) recycling Warning: Floor level obstacle
This way up Keep dry
Type BF applied part Fragile
Temperature limit Do not use if package is
damaged
REPEC
Authorised representative in
the European Community
REPCH
Authorised representative in
Switzerland
0120
United Kingdom Conformity
Assessed, with the Notified
Body number for SGS UK 1639
Conformité Européene, with the
Notified Body number for SGS
Belgium NV
Catalogue number Class II equipment
Serial number Atmospheric pressure limitation
Medical device Humidity limitation
Translation
The Keeler TonoCare is designed and built-in conformity with Directive 93/42/EEC, Regulation (EU) 2017/745 and ISO
13485 Medical Devices Quality Management Systems.
Classification: CE / UKCA: Class IIa
FDA: Class II
The information contained within this manual must not be reproduced in whole or part without the manufacturer’s
prior written approval. As part of our policy for continued product development we the manufacturer reserve the right
to make changes to specifications and other information contained in this document without prior notice.
This IFU is also available on the Keeler UK and Keeler USA websites.
Copyright © Keeler Limited 2023. Published in the UK 2023.

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TonoCare by KEELER
Symbols used on controls and display
These symbols will be used on the device and display during operation.
Device Controls Display Symbols Description
On / Standby
button
Light Turn On / Off illumination LEDs
Menu button Sound Turn On / Off audible alerts
Return button Time Set the system time
Manual trigger Date Set the system date
OD / OS button IOP Format Select the IOP format (XX /
XX.X)
Print button Pachymetry Pachymetry options of OFF/ON/
TRIGGER
(If set to ‘TRIGGER’, the
pachymetry option only
appears if the measured IOP
value is greater than 15)
Sounds
LOW
PITCH Bad or invalid
readings Brightness Set the brightness for the
displays (value between 1
and 15)
HIGH
PITCH Valid set of
measurements
obtained Self-Test Initiate a self-test of the system

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TonoCare by KEELER
1. INDICATIONS FOR USE
These devices are intended to be used only by suitably trained and authorised healthcare
professionals.
The TonoCare Non-contact Tonometer should be used only by trained
personnel. USA Federal law restricts this device to sale by or order of a
physician.
1.1 INTENDED USE / PRINCIPLE OF OPERATION
The Keeler TonoCare Tonometer is a hand-held, battery operated, non-contact tonometer
intended to be used for measuring intraocular pressure (IOP) of the human eye with less than
3D in corneal astigmatism.
The Keeler TonoCare should not be used in patients with high corneal astigmatism (>3D).
The Keeler TonoCare Tonometer uses the principle of air impulse tonometry – this is a variation
of general applanation tonometry, however, does not require direct contact with the surface of
the eye.
Applanation tonometry is a technology to accurately measure IOP as an equivalent of the force
required to flatten a defined area of the cornea by mechanical stimuli, as a direct application of
the Imbert-Fick law.
The air impulse technique requires direction of a packet of air with restricted pressure and
volume towards the central portion of the cornea, and the detection of the pre-defined
flattening of the cornea via the electrical measurement of a light beam reflected from the
corneal surface.
2. SAFETY
2.1 PHOTOTOXICITY
CAUTION: The light emitted from this instrument is potentially hazardous.
The longer the duration of exposure, the greater the risk of ocular
damage.
While no acute optical radiation hazards have been identified for Keeler
Tonometers, we recommend keeping the intensity of the light reaching
the patient’s retina to the minimum possible for the respective diagnosis.
Children, people with aphakia and people suffering from eye conditions
are most at risk. An increased risk may also occur if the retina is exposed
to the same or a similar device with a visible light source within 24 hours.
This applies, in particular, if the retina has been photographed with a
flashbulb in advance.
Keeler Ltd shall on request, provide the user with a graph showing the
relative spectral output of the instrument.

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TonoCare by KEELER
2.2 WARNINGS AND CAUTIONS
Please note that the proper and safe functioning of our instruments is only guaranteed if
both the instruments and their accessories are exclusively from Keeler Ltd. The use of other
accessories may result in increased electromagnetic emissions or reduced electromagnetic
immunity of the device and may lead to incorrect operation.
Observe the following precautions in order to ensure safe operation of the instruments.
WARNINGS
• Never use the instrument if visibly damaged and periodically inspect it for signs of damage
or misuse.
• Check your Keeler product for signs of transport / storage damage prior to use.
• US Federal Law restricts this device to sale by or on the order of a physician or practitioner.
• The device is intended for use in various clinical settings such as hospitals, eye clinics and
optometric practices.
• Only use approved Keeler power supply EP29-32777 or instrument may malfunction.
• If transporting the TonoCare in temperatures of less than 10°C, ensure the device has had
at least three hours to acclimatise to room temperature before use.
• The owner of the instrument is responsible for training personnel in its correct use.
• Never use the instrument if the ambient temperature, atmospheric pressure, and / or
relative humidity are outside the limits specified in this manual.
• Do not use in the presence of flammable gases / liquids, or in an oxygen rich environment.
• This device is intended to be used only by suitably trained and authorised healthcare
professionals.
• This product should not be immersed in fluid.
• Do not mount anything on the Docking Station other than the Hand Unit and Forehead
Rest.
• TonoCare is not intended to be used with wireless technology. Do not plug a wireless
dongle into the USB port on the Docking Station.
• The mains plug is the means of isolating the device from the mains supply. Ensure both the
power switch and mains plug are always accessible.
• Do not position the equipment so that is difficult to remove the mains plug from the wall
socket.
• Do not fit mains power adapter into a damaged mains outlet socket.
• Using the device out of specification or where there is a fault can lead to an
electric shock, overheating and/or burns.
• Route power cords safely to eliminate risk of tripping or damage to user.

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TonoCare by KEELER
CAUTION
• Use only genuine Keeler approved parts and accessories or device safety and performance
may be compromised.
• Keep out of the reach of children.
• Accuracy of IOP measurements is known to be affected by variations and changes in
corneal rigidity due to differences in corneal thickness, intrinsic structural factors or
corneal refractive surgery. It is recommended that these factors are considered during IOP
measurement.
• To prevent condensation from forming, allow instrument to come to room temperature
before use.
• Please add mounting hole labels to covering the key holes unless wall mounting the TonoCare.
• Only mount on wall according to Keeler Instructions.
• The TonoCare cannot be used in the vicinity of sources known to cause electromagnetic
disturbance (magnetic resonance imaging, computed tomography, radio-frequency
identification, metal detectors, electronic article surveillance and other electromagnetic
security systems).
• Keep the front window and nozzle area away from large amounts of dust or fine particles.
• This product should be used in a room with low / dimmed lighting.
• The device will require a minimum 12-hour charge before first use.
• The device will require several 12-hour charge cycles before the battery functions optimally.
• Before using the TonoCare, press the Manual fire button to dispel any minute particles of
dust or moisture which may have settled whilst the instrument was not in use.
• Check the function of the device in accordance with the instructions in section 6 prior to
use on the patient.
• The patient should not be in the proximity of the Docking Station.
• Do not touch the electrical contacts on the Docking Station and the patient simultaneously.
• The Forehead Rest is composed of aluminium, and it is the only part which may touch the
patient. The housing of the instrument is made of PC-ABS. Do not touch these parts if you
have a known allergy to any of the materials.
• Do not use the Forehead Rest in the Docking Station for any other instrument, or the
performance of the product may be compromised.
• Contact of the front window / nozzle area of the TonoCare with the eye of the patient
should be avoided. If accidental contact occurs, clean the front window and surrounding
area according to the cleaning instructions in section 3.1.
• Always verify that the printout matches the readings on the Hand Unit.
• For indoor use only (protect from moisture).
• There are no user serviceable parts inside. Contact authorised service representative for
further information.

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TonoCare by KEELER
• Follow guidance on cleaning / routine maintenance to prevent personal injury / damage to
equipment.
• Failure to carry out recommended routine maintenance as per the instructions in this IFU
may reduce the operational lifetime of the product.
• If the device is not used regularly it must be recharged for at least 12 hours monthly to
ensure optimum battery life.
• At product end of life dispose of in accordance with local environmental guidelines (WEEE).
Maintenance
• To maintain device performance, and ensure its safety and effectiveness it should be
serviced in accordance with the instructions in section 9.
• Only decontaminate / clean in accordance with the instructions given in section 3.1.
• If the device is not used regularly it must be recharged for at least 12 hours monthly to
ensure optimum battery life.
2.3 CONTRAINDICATION
There is no restriction to patient population this device can be used with other than those
outlined in the contraindications stated below.
Accuracy of IOP measurements is known to be affected by variations and changes in corneal
rigidity due to differences in corneal thickness, intrinsic structural factors or corneal refractive
surgery. It is recommended that these factors are considered during IOP measurement. The
Keeler TonoCare should not be used in patients with high corneal astigmatism (>3D).
3. CLEANING INSTRUCTIONS
CAUTION: Only manual non-immersion cleaning as described should be
used for this tonometer. Do not autoclave or immerse in cleaning fluids.
Always disconnect power supply from source before cleaning.
3.1 CLEAN THE PUFF TUBE LENS WEEKLY:
1. Moisten a cotton bud with de-ionised water / detergent solution (2% detergent by
volume).
2. Move the tip of the bud around the lens in a circular motion.
3. After one circle the bud should be discarded to avoid smearing on the lens.
4. Look at the Puff Tube lens from the patient’s side, if traces of tear film can still be seen,
repeat above steps until clear.
Note: Care should be taken not to damage the Puff Tube assembly during cleaning.
CAUTION: Care should be taken not to damage the Puff Tube assembly
during cleaning. Never use a dry cotton bud or tissue to clean the Puff
Tube lens. Never use a silicone impregnated cloth or tissue to clean the
puff tube lens.

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TonoCare by KEELER
3.2 CLEAN THE HAND UNIT DAILY AND BETWEEN PATIENTS
1. Wipe the external surface with a clean absorbent, non-shedding cloth dampened with
de-ionised water / detergent solution (2% detergent by volume) or water / isopropyl
alcohol solution (70% IPA by volume).Avoid using de-ionised water / isopropyl alcohol
solution with optical surfaces such as the front window. These should only be cleaned
with a de-ionised water / detergent solution
2. Ensure that excess solution does not enter the instrument. Use caution to ensure cloth is
not saturated with solution.
3. Surfaces must be carefully hand-dried using a clean non-shedding cloth.
4. Safely dispose of used cleaning materials.
4. INSTALLATION
This section will instruct how to unpack and prepare the TonoCare for use.
CAUTION: When you open the package, check for any external damage or
flaws, particularly damage to the case. If you suspect there is something
wrong with the tonometer, contact the manufacturer or distributor.
Replace the blanking plate with the appropriate mains plug adapter if required, or use IEC
60320 TYPE 7 connector (not supplied).
4.1 TOOLS REQUIRED
• Safety knife
For wall mounting:
• Pencil
• Spirit Level
• Electric drill
• PH1 screwdriver
4.2 PACKAGING CONTENT
Your TonoCare has been supplied with:
• A Hand Unit with pre-installed battery for IOP standalone measurement.
• A Docking Station for printing, data export and charging functions.
• A metal wall mounting plate with 4 screws and 4 rawlplugs for wall mounting of the
Docking Station.
• A power supply for directly charging the Hand Unit (in transport) or via the Docking
Station.
• A roll of thermal paper to be used in the printer located in the Docking Station.
• A USB device containing the Instructions for Use.

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TonoCare by KEELER
• An extendable Forehead Rest.
• A USB cable to connect the Docking Station with a computer (not provided) for data
export.
• A Tonometer Face Shield to provide a layer of protection between the patient and user.
4.3 TABLETOP INSTALLATION
1. Position the product package so that the arrow points upward
2. Use a safety knife to cut the tape sealing the box on the top and remove the polystyrene
layer covering the package contents.
Use caution to avoid injury from sharp edges when handling the safety
knife, and the unsealed carton edges.
3. Lift the Docking Station from the package and place it in a clean area intended for the
charging of the TonoCare when not in use.
The TonoCare Hand Unit should not be used in the proximity of the
Docking Station.
4. Insert the roll of thermal paper provided, according to instructions on section 8.
5. Remove the Hand Unit from the package and allow the handle to fit the lower recess in
the Docking Station and the Measurement Window to slide onto the top of the Docking
Station. Before use, remove the protective film covering the TonoCare display, the Front
Window and the IR Window.
6. Take the Forehead Rest from the package and allow it to be held by its magnets at the
top of the Docking Station, in the area provided for it.
7. Remove the power supply from the package, plug it to the back of the Docking Station
and after fitting the suitable adapter for your country,connect it to the AC inlet.
Route power cords safely to eliminate risk of tripping to user, or damage
to device.
8. The LED indicator in the Hand Unit should now light up to indicate the TonoCare battery
is charging.
9. Use the USB cable provided to connect the Docking Station to a computer (not provided)
for data export. The computer must be compliant to EN 60601-1 (see section 12)
4.4 WALL MOUNT INSTALLATION
1. Choose carefully the intended location for your TonoCare Docking Station with particular
consideration to the routing of the power cable and the patient screening position.
Ensure that the mains plug is accessible at all times, as this is the primary means of
mains power disconnection.

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TonoCare by KEELER
The TonoCare Hand Unit should not be used in the proximity of the
Docking Station. The Docking Station should not be fixed over live
utilities, as the drilling process could interrupt the utility supply and cause
injury. The recommended height is 1.2m (4 feet).
2. Use the metal plate as a template to mark the position of the retaining screws with a
pencil, holding a spirit level to the base of the plate to guarantee horizontal alignment.
3. Drill the appropriate size holes following the marks left from the previous step.
Use extreme caution when operating the drill, following the instructions
provided with the instrument.
4. Insert the rawlplugs in the holes drilled in the previous step, and fix the metal plate on
the wall with the screws provided, using a PH1 screwdriver.
5. Position the Docking Station on the wall mounting plate so the 2 retaining pins on the
metal plate slide into the holes in the rear of the housing, and the plate supports the
unit from below.
6. You may now plug the power cable into the Docking Station, and connect it to mains
power. The Docking Station will blink twice at power up. Once powered, rest the hand
5. USING THE TONOCARE
This section will instruct the user on how to interpret the controls and indicators of the
TonoCare, and how to perform the IOP measurement on a patient using the device.
Familiarise yourself with the instructions for the measurement of the IOP
using the TonoCare, before using the instrument on a patient.
5.1 CONTROLS AND INDICATORS
Hand Unit
Top view
1Forehead Rest mounting
2Manual Trigger
3OD / OS button
4LED indicator
5Digital Display
6On / Off
7Print button
8Menu button
9Return button
1
65
3
2
4
79
8

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Note: The LED indicator on the TonoCare pulses when charging and remains solid when fully
charged
Isometric view from the user and left side
10 Forehead Rest
11 Eyepiece
View from underneath the tonometer
12 Charging contacts
13 Power input
Patient view
14 Puff Tube and window
15 LED indicator
16 Infrared transmitter
Docking Station
Rear view
17 Charging contacts
18 Infrared receiver
19 Printer door
20 Wall mounting
holes
11
10
13
12
18
17
20
19
15
14
16

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TonoCare by KEELER
Underside view
21 Power input
22 USB interface – Allows tonometer to be connected
to a PC for raw data upload purposes.
5.2 MENU MAP
Press the Menu button to open the Software Menu. Once in Software Menu, use the Menu
button to change your selection, the Print button to confirm and the Return button to move to
the previous menu. Follow the Menu Map in the figure on page 14 for guidance.
21
22
View to show position
of Hand Unit with
Docking Station
The software revision is
displayed during start-up
Confirm (Print button)
Change selection (Menu button)
Return to previous menu (Return
button)

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6. MEASUREMENT PROCEDURE
6.1 ROUTINE CHECKS AND FUNCTIONAL TESTS
1. Before daily use, visually examine the Hand Unit and Docking Station, looking for any
signs of obvious damage. If you suspect the tonometer has been subjected to any
impacts or moisture ingress do not use the tonometer. Contact Keeler or your local
service centre for advice.
2. Keeler recommends performing a weekly self-test on the Hand Unit to confirm
functionality. This verifies operation of the puff generation system and the pressure
sensor. To access the self-test facility, follow these steps:
a) Power the tonometer up, ensuring it is plugged into the mains power supply.
b) Rest the tonometer on its side on a flat surface, such as on a desk. Do not hold the
tonometer.
c) Press and hold the Menu button and scroll through until the icon appears on
the display.
d) Using the Print or Return button set this to ON.
e) Press and hold the Menu button again to exit the menu (approximately 2 seconds).
f) The tonometer will puff several times and display a series of numbers as it
progresses through the test.
g) Once the self-test is complete the tonometer will indicate that it has passed or failed
on the display.
Remember to prepare the patient before initiating the measurement. A
patient’s anxiety may delay the measurement and adversely affect its
accuracy.
A single reading can be misleading as the IOP will vary in response to
pulse, respiratory and diurnal fluctuations. Other factors may affect
IOP, such as blinking, eye squeezing, fluid intake, physical activity, body
position, etc. Up to 4 readings may be required to reduce the impact of
these variants to a constant IOP. Keeler recommends using the average of
four readings rather than any individual reading.
Main Menu
Light
On/O
ff
Buzzer
On/Off
Time
HH
MM
Date
DD
MM
YY
Resolution
XX
XX.X
CCT
On/Off/
Trigger
Brightness
On/Off
Self T
est
On/Off

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The TonoCare software will recognise the readings and give an audible notification when two
consecutive readings are within 1mmHg of each other, indicating that further measurements
may not be required.
6.2 PREPARING THE DEVICE
1. Before lifting the Hand Unit from the Docking Station, check the LED indicator is steady
on to ensure full battery capacity. A full battery will last up to 2 days of intensive use.
Performance will deteriorate over time.
2. Remove the Hand Unit from the Docking Station and press the Power On button. The
Hand Unit will enter Standby Mode if not used for more than 90 seconds.
6.3 PREPARING THE PATIENT
Before using the TonoCare tonometer you should make your patient feels at ease and ensure
they are in an optimum reading location, preferably with their head supported. This is because
apprehension and nervousness may adversely affect the readings obtained. Follow the points
outlined below to achieve this:
1. Ensure that the patient is comfortable and in a relaxed position.
2. Ask the patient to remove their contact lenses or spectacles if worn and to breathe
normally. The patient’s eyes should be fully open and blinking normally throughout the
complete measurement procedure.
3. To reassure the patient, you can demonstrate the measurement procedure using the
Manual trigger button towards one of the patient’s fingers. Re-set (long press OD / OS)
the tonometer after the demonstration.
Before taking a reading, you should:
1. Ask the patient to blink to ensure a good and reflective tear film.
2. Ensure the patient and tonometer optics are not positioned under direct lighting (i.e.
spot lights or sunlight).
3. Ensure the patient’s eyes are fully opened. This helps to prevent squeezing, where the
patient unconsciously tenses their eyelids and increases IOP.
4. Throughout the reading process, you should allow the patient to blink at intervals to
maintain the corneal tear film.
6.4 TAKING THE READING
Once the TonoCare and the patient are prepared, you are ready to take a reading.
1. If you haven’t done it in the previous step, use the manual trigger / demo button to
dispel any minute particles of dust or moisture which may have settled whilst the
TonoCare was not in use.
The TonoCare is set to automatically select the right eye as the first eye to
be measured. If you wish to select the left eye, press the OD / OS button.
Ensure you are recording the measurement for the intended eye.

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2. Hold the Hand Unit with the dominant hand and position the tonometer so it is aligned
with the patient’s eye from a distance of about 30cm or 12 inches.
3. Move the tonometer in towards the patient until the Forehead Rest is positioned against
their forehead. You may choose to rest your fingers on the Forehead Rest to gain more
stability.
4. Ask the patient to focus on the green target inside the tonometer.
5. Using your preferred eye, look through the eyepiece so that you can see the patient’s
eye. Keep moving the tonometer forward whilst aligning the positioning ring to the
patient’s limbus. The entire iris does not need to be visible as it may be covered by an
eyelid. Centre the measurement area with the pupil of the patient’s eye and make note
of the reflected LED crescents. These should be central on the pupil as well.
6. When the tonometer is approximately 15mm (0.5 inches) away from the patient’s eye, a cross
will appear to indicate the position of the tonometer relative to the eye. Move the tonometer
so that the edges of the cross are just inside the corners of the measurement brackets.
The cross must not be larger than the measurement area, as this would
indicate that the tonometer is too close to the eye.
7. Once the cross reaches the correct alignment position, a gentle air impulse will trigger
an IOP reading. Ensure eyelids and eyelashes are clear of the measurement brackets to
obtain accurate results.
If no applanation was recorded during the puff, a low-pitch tone will be
heard (if sounds are enabled in the menu setting) and two stars (**) will
be shown on the internal display.
8. Ensure an IOP reading has been recorded on the
tonometer.
9. Slowly move the tonometer backwards and allow the
patient’s eye to rest for a few seconds, maintaining the
alignment position.
10. When the patient is ready for another reading, move the tonometer closer until the
alignment cross appears again and another reading is triggered.
11. Repeat the previous steps for further readings until the measurement averaged from the
individual readings is acceptable.
12. When two consecutive readings are within 1mmHg, an audible high pitch tone will be
heard indicating that sufficient readings may have been taken (if Buzzer is enabled in the
User Menu Options). If successive readings are not within 1mmHg of each other, Keeler
recommends taking up to four readings and using the average.
*Correct position and size of
cross in measurement area