Keeler Tonocare User manual

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The information contained within this manual must not be reproduced in whole or part
without the manufacturer’s prior written approval.
The manufacturer reserves the right to make changes to specifications and other information
contained in this document without prior notice.
TonoCare™ is a registered Trademark of Keeler Limited 2017.
Copyright © Keeler Limited 2016. Published in the UK 2017.

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1.0 Introduction....................................................................p4
1.1 Device Classification.................................................p4
1.2 Indication for use.....................................................p4
1.3 Warnings...................................................................p4
1.4 Principle of operation..............................................p4
1.5 Symbols information................................................p5
1.6 Symbols used on controls and display....................p6
1.7 Warnings and cautions............................................p7
2.0 Installation......................................................................p9
2.1 Tools required ..........................................................p9
2.2 Packaging content ...................................................p9
2.3 Table top installation.............................................p10
2.4 Wall mount installation.........................................p11
3.0 Using the TonoCare .....................................................p12
3.1 Controls and indicators..........................................p12
3.1.1 Hand unit.............................................................p12
3.1.2 Docking station ...................................................p14
3.1.3 Menu map ...........................................................p15
3.2 Measurement .........................................................p16
3.2.1 Routine checks and functional tests..................p16
3.2.2 Preparing the unit ..............................................p17
3.2.3 Preparing the patient .........................................p17
3.2.4 Obtaining a measurement .................................p18
3.2.5 Repeatability and reproducibility ......................p20
3.2.6 Clinical performance data ..................................p21
3.2.7 CCT correction .....................................................p25
3.2.8 Printing data .......................................................p26
3.3 Replacing the printer paper..................................p27
3.4 Charging your TonoCare .......................................p28
4.0 Product care and maintenance ...................................p29
4.1 General product care.............................................p29
4.2 Cleaning..................................................................p30
4.3 Maintenance ..........................................................p31
4.4 Fault Codes .............................................................p31
5.0 Specifications and electrical ratings...........................p32
6.0 Specifications and electrical ratings (EMC)................p34
7.0 Accessories and warranty ...........................................p39
8.0 Contact, packaging and disposal information ..........p40
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Contents

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1.0 Introduction
Thank you for purchasing the Keeler TonoCare™.
These Instructions For Use are addressed to healthcare
professionals using the TonoCare Non-contact Tonometer.
The device should only be used by trained and qualified
personnel.
1.1 Device Classification
CE Regulation 93/42 EEC: Class IIa
FDA: Class II
1.2 Indication for use
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.
1.3 Warnings
The Keeler TonoCare should not used in patients with high
corneal astigmatism (>3D).
1.4 Principle of operation
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.
The device is intended to be used in accordance with
these instructions. Please read them carefully and keep
this document safe for future reference.

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1.5 Symbols information
Follow instructions for use
Mandatory action sign
General warning sign
Warning:
Dangerous voltage
Warning:
Trip hazard
Warning:
Optical radiation hazard
Warning:
Non-ionizing radiation
Class II Equipment
Power supply polarity
Manufacturer’s name and address
Date of manufacture
Catalogue number
Serial number
Do not use if package is damaged
Fragile
Keep dry
Temperature limits
Humidity limits
Atmospheric pressure limits
This way up
The CE mark on this product
indicates it has been tested to, and
conforms with the provisions noted
within the 93/42/EEC Medical Device
Directive
This symbol on the product or its
packaging indicates it was put on
the market place after August 2006,
and this product shall not be treated
as household waste
RoHS compliant
Material suitable for recycling
Please pay attention to the description of symbols below, as they will be used throughout the manual, device and packaging.

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1.6 Symbols used on controls and display
Please pay attention to the description of the symbols and sounds below, as they will be used on the device and display during operation.
On/Standby button
Menu button
Return button
Manual trigger
OD / OS button
Print button
Bad or invalid readings
Valid set of measurements obtained
Device Controls Display Symbols Description
Light Turn on / off illumination LEDs
Sound Turn on/off audible alerts
Time Set the system time
Date Set the system date
IOP Format Select the IOP format ( XX / XX.X)
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)
Brightness Set the brightness for the displays
(value between 1 and 15)
Self Test Initiate a self-test of the system
Sounds
LOW
PITCH
HIGH
PITCH

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1.7 Warnings and cautions
Warnings and Cautions – failure to follow these instructions may pose a risk of injury
Environment
• The product has been designed to function safely when at an
ambient temperature between +10ºC and +35ºC.
• Do not use in the presence of flammable gases / liquids, or in an
oxygen rich environment.
• 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).
• Do not bring the TonoCare into a magnetic resonance environment.
• 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 subdued lighting.
Installation and setup
• Please add mounting hole labels to covering the key holes unless
wall mounting the TonoCare.
• Only mount on wall according to Keeler Instructions.
• Keep out of reach of children.
• Do not mount anything on the docking station other than the
hand unit and forehead rest.
• The mains plug is the means of isolating the device from mains
supply - ensure the mains plug is accessible at all times.
• 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.
• Route power cords safely to eliminate risk of tripping to user, or
damage to device.
• TonoCare is not intended to be used with wireless technology.
Do not plug a wireless dongle into the USB port on the docking
station.
Operation and use
• USA Federal law restricts this device to sale by, or order of a
physician.
• The 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.
• Do not use if the product is visibly damaged, and periodically
inspect for signs of damage.
• This product should not be immersed in fluids.

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1.7 Warnings and cautions (continued)
Warnings and Cautions – failure to follow these instructions may pose a risk of injury
Operation and use (continued)
• Only use the approved Keeler accessories from the list in section
7.0, or the instrument may malfunction.
• 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.
• To prevent condensation from forming, allow instrument to come
to room temperature before use.
• 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 3.2 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 4.2.
• The printer on the docking station contains a sharp serrated blade
to help cut the paper. Exercise caution to avoid contact with this
blade whenever replacing printer paper rolls or tearing printouts
from the device.
• Always verify that the printout matches the readings on the hand
unit.
Maintenance
• To maintain device performance, and ensure its safety and
effectiveness it should be serviced in accordance with the
instructions in section 4.3.
• Only decontaminate/clean in accordance with the instructions
given in section 4.2.
• If the device is not used regularly it must be recharged for at least
12 hours monthly to ensure optimum battery life.

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2.0 Installation
This chapter will instruct how to unpack and prepare the
TonoCare for use.
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.
2.1 Tools Required
• Safety knife
For wall mounting:
• Pencil
• Spirit Level
• Electric drill
• PH1 screwdriver
2.2 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.
• An extendable forehead stabilizer.
• A USB cable to connect the docking station with a computer
(not provided) for data export.

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2.3 Table Top 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. Before use remove the protective film covering the
IR window on the docking station.
The TonoCare hand unit should not be used in the
proximity of the docking station.
4. Pull open the printer door, found on the left-hand side of the
docking station, and insert the roll of thermal paper provided.
Proceed to section 3.3 for further instructions on installation /
replacement of thermal paper.
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 stabilizer 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 geography 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 60601-1:2006 (see section 5.0)

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2.4 Wall Mount Installation
Your TonoCare has been supplied with a wall mounting plate,
4 screws and 4 rawlplugs. Follow the instructions below for wall
mounting.
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.
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 unit on the
docking station for charging.
Charge the unit for a minimum of 12 hours before
first use.

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3.0 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.
3.1 Controls and indicators
3.1.1 Hand Unit
• Top view
1. Forehead rest mounting
2. Manual trigger
3. OD / OS button
4. LED indicator
5. Digital display
6. On / Off
7. Print button
8. Menu button
9. Return button
Note: The LED indicator on the TonoCare pulses when
charging and remains solid when fully charged.
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3.1.1 Hand Unit (continued)
• Isometric view from the user and left side
10. Forehead rest
11. Eyepiece
• View from underneath the device
12. Charging contacts
13. Power input
• Patient view
14. Puff tube and window
15. LED indicator
16. Infrared transmitter

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3.1.2 Docking station
• Underside view
21. Power input
22. USB interface
• Allows device to be connected to a PC for raw data
upload purposes
• View to show position of Hand
Unit with Docking Station
• Rear view
17. Charging contacts
18. Infrared receiver
19. Printer door
20. Wall mounting holes

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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 below for guidance.
3.1.3 Menu Map
Confirm (Print button)
Change selection (Menu button)
Return to previous menu (Return button)
The software revision is
displayed during start-up
Main Menu
Light Buzzer Time Date Resolution CCT Brightness Self Test
On/Off On/Off HH DD XX On/Off/Trigger On/Off On/Off
MM MM XX.X
YY

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3.2 Measurement
3.2.1 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 unit has been subjected to any impacts or moisture
ingress do not use the device. 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 unit up, ensuring it is plugged into the mains power supply.
b. Rest the unit on its side on a flat surface, such as on a desk. Do not hold the unit.
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 device will puff a number of times, and display a series of numbers as it progresses
through the test.
g. Once the self-test is complete the device will indicate that it has passed or failed on the
display.

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3.2 Measurement (continued)
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 in order to reduce the impact of
these variants to a constant IOP. Keeler recommends using the
average of four readings rather than any individual reading.
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.
3.2.2 Preparing the unit
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.
3.2.3 Preparing the patient
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. In order 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 device after the demonstration.

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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.
2. Hold the hand unit with the dominant hand, and position the
device so it is aligned with the patient’s eye from a distance of
about 30 cm or 12 inches.
3. Move the device 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 device.
5. Using your preferred eye, look through the eyepiece so that you
can see the patient’s eye. Keep moving the instrument forward
whilst aligning the positioning ring to the patient’s iris. 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 device is approximately 15mm (0.5 inches) away
from the patient’s eye, a cross will appear to indicate the
position of the device relative to the eye. Move the device 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 device 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 device.
3.2.4 Obtaining a measurement
* Correct position
and size of cross in
measurement area

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8. Slowly move the device backwards and allow the patient’s
eye to rest for a few seconds, maintaining the alignment
position.
9. When the patient is ready for another reading, move the
device closer until the alignment cross appears again and
another reading is triggered.
10. Repeat the previous steps for further readings until the
measurement averaged from the individual readings is
acceptable.
11. When two consecutive readings are within 1mmHg an
audible high pitch notification will be heard indicating that
sufficient readings may have been taken (if sounds are
enabled in the menu settings). If successive readings are not
within 1mmHg of each other, Keeler recommends taking up
to four readings and using the average.
12. Press the OD/OS button to switch from left to right eye, or
vice-versa.
13. Press and hold the OD/OS button to clear all the readings.
14. Pressing the print button will produce a paper printout from
the printer installed in the docking station. The infra-red
window in the docking station and hand unit should be
unobstructed, and aligned within 1m (3 feet). The Docking
Station LED will flicker during the transmission of the IR data
and then extinguish when printing.
15. If the docking station is connected to a computer, pressing
the print button will export the raw data to the computer, as
long as the serial port has been enabled as described below.
3.2.4 Obtaining a measurement (continued)

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Repeatability and reproducibility of TonoCare were assessed by
measuring a manometrically controlled test eye.
Repeatability was measured using a single TonoCare device and
a series of approximately 50 individual readings for each of 5
pressure values spaced evenly between the 5 to 50mmHg
working range. Readings were cross referenced with a reference
pressure meter and a Pulsair IntelliPuff device. Failed readings
were rejected and averages of 3 subsequent readings were
calculated to give a set of approximately 16 measurements at
each of the 5 pressure values. Results demonstrate standard
deviations ranging from 0.14mmHg to 1.11mmHg within the 5
to 50mmHg pressure range respectively.
Reproducibility was assessed by analysing measurements from
three different TonoCare units by two different operators across
5 pressure values spaced evenly between the 5 to 50mmHg
working range. Two measurements (an average of 4 readings) at
the 5 pressure values were taken for each of the six test cases
(each operator using each of the three TonoCare devices).
An Analysis of Variance (ANOVA) conducted on the data
indicates a p-value of less than 0.05 and an R-square value of
98% or 99%, which signifies excellent reproducibility across
operator and across devices.
3.2.5 Repeatability and reproducibility