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.

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Contents

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

3.2.1 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

3.1.3 Menu map ...........................................................p15

3.2 Measurement .........................................................p16

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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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.

1.4 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.

1.3 Warnings

The Keeler TonoCare should not used in patients with high

corneal astigmatism (>3D).

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

Please pay attention to the description of symbols below, as they will be used throughout the manual, device and packaging.

Follow instructions for use

Mandatory action sign

General warning sign

Warning:

Dangerous voltage

Warning:

Trip hazard

Warning:

Optical radiation hazard

Warning:

Non-ionizing radiation

Manufacturer’s name and address

Date of manufacture

Catalogue number

Serial number

Do not use if package is damaged

Fragile

Keep dry

Temperature 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

Class II Equipment

Power supply polarity

Humidity limits

Atmospheric pressure limits

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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.

Device Controls

On/Standby button

Menu button

Return button

Manual trigger

OD / OS button

Print button

Sounds

LOW

PITCH

Bad or invalid readings

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)

HIGH

PITCH

Valid set of measurements obtained

Self Test Initiate a self-test of the system

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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 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.

• 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.

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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

• 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.

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.

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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.

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

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.

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

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.

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.

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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

• Rear view

17. Charging contacts

18. Infrared receiver

19. Printer door

20. Wall mounting holes

• 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

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3.1.3 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 below for guidance.

Confirm (Print button)

Change selection (Menu button)

Return to previous menu (Return button)

Main Menu

Light Buzzer Time Date Resolution CCT Brightness Self Test

On/Off On/Off HH DD XX

On/Off/Trigger

The software revision is

displayed during start-up

On/Off On/Off

MM MM XX.X

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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.

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.

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.

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3.2.4 Obtaining a measurement

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.

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.

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.

8. Ensure an IOP reading has been recorded on the device.

* Correct position

and size of cross in

measurement area

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3.2.4 Obtaining a measurement (continued)

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

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.

to four readings and using the average.

12. Press the OD/OS button to switch from left to right eye, or

vice-versa.

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3.2.5 Repeatability and reproducibility

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

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.

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).

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3.2.6 Clinical performance data

Summary

The Keeler TonoCare Non-Contact Tonometer (NCT) was

compared with the Perkins Applanation Tonometer (AT) in order

to assess whether the TonoCare meets the requirements of ISO

8612 (comparable to ANSI Z80.10) in design compliance testing.

The Perkins AT uses the same basic principle as the Goldmann

AT, namely, varying the force applied to applanate a fixed area

of the cornea. Both instruments have an applanating ‘cone’

comprised of two prisms with apices joined together to apply an

external force to the cornea to indent and flatten its surface.

There are several scientific articles referring to both instruments

as reference standard tonometers and specifically the Perkins AT

as the portable counterpart to the Goldmann AT (Wessels,I.F et

al.,1990), (Carlos Garcia-Resua et al 2006), useful in domiciliary

visits and for patients with mobility issues.

Two experienced observers acquired data from 144 qualifying

eyes, measuring IOPs ranging from 7mmHg-23mmHg in 50

participants and IOPs greater than 23mmHg in 22 participants.

The results of the study show that the IOP measurements taken

with the TonoCare NCT when compared to the reference Perkins

tonometer (AT) do not exceed the ±5mmHg tolerance in the

three IOP ranges in 143 eyes with only 1 eye exceeding this

tolerance for IOP measured >23mmHg. This falls well below the

requirement that no more than 5% of the paired differences

between TonoCare and the reference tonometer should be

outside the ±5mmHg tolerance in the three IOP ranges.

Overall the mean of IOP differences between TonoCare and

Perkins AT was <0.01 mmHg, with a median of -0.2mmHg,

indicating that the TonoCare NCT is equivalent to the

applanation tonometer.

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3.2.6 Clinical performance data (continued)

Methods

The study conducted was a single visit, single- centre,

non-randomized, non-masked paired crossover study. The study

obtained IOP measurements on each eligible eye with the

TonoCare and the reference standard Perkins tonometer.

Subjects were recruited according to the following inclusion and

exclusion criteria.

Inclusion Criteria

• Subjects must be over 18 years of age

• Subjects must have healthy corneas with no contraindications

for IOP measurements

Exclusion Criteria

• Subjects with only one functional eye

• Subjects with one eye having poor or eccentric fixation

• High corneal astigmatism (>3D)

• Corneal scarring, corneal surgery (including laser corneal surgery)

• Microphthalmosis

• Buphthalmos

• Contact lens wearers

• Dry eyes

• Lid squeezers

• Nystagmus

• Keratoconus

• Any other corneal or conjunctival pathology or infection

A total of 74 eligible participants were recruited, with 2

participants (2.7%) excluded. The reason for exclusion of two

participants was due to excessive blinking or anxiousness resulting

in the participant holding their breath. From the included 72

participants, IOP was measured in both eyes of all participants with

TonoCare and Perkins AT, giving paired IOP measurements for a

total of 144 eyes.

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3.2.6 Clinical performance data (continued)

Results

Table 1 below gives summary of IOP characteristics of the group,

showing measurements to have similar distributions.

Table 1: Summary of TonoCare and Perkins AT IOP measurements.

TonoCare Perkins AT

N, eyes (patients) 144 (72) 144 (72)

Mean IOP, mmHg 21.2 21.2

Median IOP, mmHg 18.0 17.0

SD*, mmHg 7.9 8.0

Range, mmHg 11.8 to 46.3 11.0 to 41.0

IOP 7 to 16mmHg, n (%)

IOP 17 to 23mmHg, n (%)

IOP >23mmHg**, n (%)

No pairing structure is summarised in this table. *Standard deviation.

†

Only Perkins AT IOP categories are used for sub-group analyses, n is given in terms of eyes.

** In order to obtain measurements in this range, an inversion procedure was performed on a

subset of participants while taking IOP measurements.

†

42 (29.2) 51 (35.4)

58 (40.3) 49 (34.0)

44 (30.6) 44 (30.6)

Table 2: Differences between TonoCare and Perkins AT IOP

measurements >5mm Hg overall, and within 3 IOP subgroups.

IOP Group

7 to

16mmHg

Does not

exceed

±5mm Hg

Difference*

* IOP TonoCare – IOP Perkins AT. †Based on Perkins AT measured IOP.

** In order to obtain measurements in this range, an inversion procedure was performed on a

subset of participants while taking IOP measurements.

Exceeds

±5mmHg

Total 51 49 44 144

51 49 43 143

0 0 1 1

17 to

23mmHg >23mmHg** Total

†

Summary parameters of differences between pairs of TonoCare

and Perkins AT IOP measurements are given in Table 3 below, for

the full sample and by each IOP group. Overall the mean of IOP

differences between TonoCare and Perkins AT was <0.01 mmHg,

with a median of -0.2mmHg. The 95% limits of agreement, based

Table 2 categorises the absolute differences between TonoCare

and Perkins AT IOP measurements >5mmHg overall, and within 3

IOP subgroups. A difference greater than the tolerance of

±5mmHg occurred in 1 (0.7%) eye out of 144, well below the

maximum level of 5% according to the standard.

on the mean of IOP differences ±1.96 × the standard deviation of

the IOP differences was -3.4mmHg to +3.4mmHg.

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3.2.6 Clinical performance data (continued)

Table 3: Summary measures of IOP differences taken with

TonoCare and Perkins AT measurements, summarised overall, and

within 3 IOP subgroups.

IOP Group

7 to 16mmHg

(n=51)

Mean 0.3 0.2 -0.6 0.0

Summary measure [mmHg]

†

Based on Perkins AT measured IOP. *Standard deviation. §Interquartile range.

** In order to obtain measurements in this range, an inversion procedure was performed on a

subset of participants while taking IOP measurements.

Median 0.2 0.2 -0.9 -0.2

SD* 1.3 1.5 2.1 1.7

IQR

Range -3 to 4 -4.0 to 4.0 -3.8 to 6.2 -4.0 to 6.2

-0.4 to 1.2 -0.8 to 1.0 -1.8 to 0.1 -1.0 to 1.0

17 to 23mmHg

(n=49)

†

>23mmHg**

(n=44)

It was concluded by the investigators that there are no clinically

meaningful differences in IOP measurements among the

tonometers, and that the TonoCare conforms to the standard

as detailed.

Overall

(n=144)

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3.2.7 CCT correction

1. Press and hold the menu button to open the software menu. Follow

the menu map in section 3.1.3 to ensure the CCT correction function

is enabled.

2. Follow the instructions in section 3.2.4 to retrieve an IOP

measurement. Once a suitable average reading is obtained, follow

the CCT workflow shown below. The CCT group selected for the

patient should correspond to the one measured separately by a

pachymeter. Use the menu button to confirm your selection.

3. The CCT screen will show the CCT group and the correction

applied under the relevant eye.

TonoCare CCT Workflow

Obtain

readings for

either one or

both eyes

Menu button

Short press

OD/OS Button

CCT dialog

(selection list)

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. The biomechanical properties of an individual

cornea may vary, resulting in changes of the relative stiffness

or rigidity of the cornea and altering the measurement.

Other factors to consider include corneal edema and other

corneal abnormalities potentially affecting rigidity (e.g.,

keratoconus, corneal transplant, crosslinking) in addition to

intrinsic structural factors and corneal refractive surgery.

Return button

OD/OS button

toggles:

1. OD

Show CCT

screen:

2. OD+CCT

3. OS

4. OS+CCT

Menu button

Short press

CCT dialog

(selection list)

Return button

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3.2.8 Printing data

The measurement results can be printed by pressing the print

button on the hand unit.

This will automatically include the date and time (if set).

A space is included for manually recording the name of

the patient.

The last four individual readings are printed as whole

numbers ‘XX’.

The average IOP is calculated and printed to

one decimal place ‘XX.X’.

Always verify that the data on the printout and data on

the TonoCare Export application matches the readings

on the hand unit.

Example:

The TonoCare docking station can also be connected to a USB

port on a PC. It will appear as a serial port in the system.

To receive the measurement data, the port needs to be

configured as follows:

- Baud rate: 115200

- Data bits: 8

- Stop bits: 1

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.

- Parity: none

- Flow control: none

Pressing the print button will send the

results to both the printer and

the USB port.

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3.3 Replacing the printer paper

1. Access to the printer paper is via the printer cover. Using your fingertip, locate the lip on the

top of the cover and gently pull towards you to open the printer housing.

2. Remove any leftover paper roll.

3. Place the new roll of paper into the paper holder, making sure the free end is loose at the top

of the roll and oriented as shown.

4. Extend a few centimetres of paper out of the housing. While holding the end of the paper,

close the cover by gently pushing the lip at the top towards the docking station until it is fully

closed and clicks into place.

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.

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3.4 Charging your TonoCare

When not in use Keeler recommends storing your TonoCare on

the docking station, so that it is maintained fully charged and

ready for use.

The LED on the TonoCare pulses when charging.

Once fully charged the LED will be continuously lit.

The LED on the Docking Station will not change when the

TonoCare hand set is stored on the Docking Station.

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4.0 Product care and maintenance

Follow the instructions from this section for the safe

care, cleaning and maintenance of your TonoCare.

4.1 General product care

Always inspect the product before use, checking for normal

start-up.

Do not attempt to perform product disassembly, reassembly or

repair. These should only be done by personnel trained and

qualified by Keeler, following the instructions in the service

manual.

Do not store the product in a dusty environment, as the dust

may enter the puff system, and be dispelled to the patient’s eye

during use.

Regular inspection

Inspect your power supply unit and cable for damage regularly.

Before inspecting, disconnect the power supply from the

TonoCare and the mains supply.

If the outer insulation of the cable appears to be damaged

discontinue use immediately. Contact your local dealer for a

replacement.

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4.2 Cleaning

Do not autoclave or immerse in cleaning fluids. Always

disconnect power supply from source before cleaning.

Disinfect the unit carefully following the procedures and

cleaning solutions described below.

Clean the puff tube lens weekly

1. Moisten a cotton bud with 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.

Clean the hand unit daily and between patients

1. Wipe the external surface with a clean absorbent,

non-shedding cloth dampened with a water/detergent

solution (2% detergent by volume) or water/isopropyl alcohol

solution (70% IPA by volume). Avoid using water/isopropyl

alcohol solution with optical surfaces such as the front

window. These should only be cleaned with a 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.

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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4.3 Maintenance

If your TonoCare is dropped please return it to your local authorised Keeler Service Centre.

Keeler recommends annual service of your TonoCare to

ensure the best performance of the device.

There are no user replaceable parts inside the device, including

the battery. The battery must only be replaced by trained service

personnel following the instructions in the Service Manual.

If you notice a significant reduction of the battery’s

performance, contact Keeler or your authorized distributor for

its replacement.

If the TonoCare is dropped by accident the same service centre

or distributor can verify if the device is still in calibration.

Do not attempt to perform any unauthorized repairs, as

this could endanger the product and patients. Do not

allow unauthorized parts to be fitted in your product.

On request, Keeler will provide necessary circuit diagrams,

component parts lists, descriptions and calibration instructions to

assist service personnel in device repair.

The MOD RECORD label on the rear of the

device is used to indicate the status of the device

in relation to significant changes.

4.4 Fault Codes

If an Error Code between 00 to 34 is seen on the screen, restart

the device and check its function. If the device does not clear

The unit performs a self-function check when switched on and

will indicate if a fault is found. A further self-test can be

activated from the menu (refer to section 3.2.1).

please return it to your nearest authorised Keeler Service Centre.

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5.0 Specifications and electrical ratings

TonoCare Hand Unit

Electric shock protection Class II (or internally powered)

Complies with Electrical Safety (Medical)

IEC 60601-1:2005+AMD1:2012. IEC 60601-1-2:2014 BS EN ISO 15004-1:2009

The Mains plug is the means of isolating the device from the mains supply – ensure the mains plug is accessible at all times.

* If connecting the TonoCare to a computer, the computer shall comply with the requirements of EN 60601-1:2006 ** Whenever the device is connected to other equipment, the combination shall comply with the requirements of EN 60601-1:2006

IP rating IPX0

Dimensions 220 x 136 x 206mm (H x W x D)

Weight 1.044Kg

Calibrated range 5mmHg to 50mmHg

Accuracy +/-5mmHg (95% confidence level)

Displayed accuracy Display accuracy to 1 decimal place

e.g. 12.3

Working distance 11mm from surface of patient’s cornea to front surface of the window.

Display OLED 0.95”

Docking Station

Electric shock protection Class II

IP rating IPX0

Dimensions 153 x 155 x 183mm (H x W x D)

Weight 0.725Kg

Power Supply Unit Switch mode, multi-plug type

(110 – 240V)+/- 10% 350-700mA Compliant to: EN 60601-1, EN 61000-6-2, EN 61000-6-3

Power supply output 30 VA (12V DC 2.5A)

Frequency 50/60 Hz

TonoCare & Docking Station Environmental Conditions

Operation Storage Transport

Temperature limits

Humidity limits

Pressure limits

+10˚C to +35˚C -10˚C to +55˚C -40˚C to +70˚C

30% to 90% 10% to 95% 10% to 95%

800 to 1060hPa 700 to 1060hPa 500 to 1060hPa

Illumination system LED, white and infrared

The ME Equipment includes the hand unit, the docking station, the forehead rest and the power supply.

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5.0 Specifications and electrical ratings (continued)

It is well established that exposure of the eye to intense light

sources for extended periods of time poses a risk of retinal

photic injury. Many ophthalmic instruments illuminate the

eye with intense light. The light levels on the TonoCare have

been set at the lowest level possible.

No visible retinal lesions have been identified as a result of

using Pulsair tonometers, however, young children and

Figure 1: Spectral irradiance of instrument at patient plane

persons with diseased eyes may be at a higher risk. The risk

may also be slightly increased if the person being examined

has had any exposure with the same instrument or another

ophthalmic instrument using an intense visible light source

during the previous 24 hours. This will apply particularly if

the eye has been subjected to retinal photography.

Parameter

ES-CL 250-400 2.358 E-05 μW cm-2

EUV-CL 360-400 2.707 E-07 mW cm-2

EA-R 305-700 1.027 E-02 μW cm-2

EIR-CL 770-2500 2.73 mW cm-2

EVIR-R 380-1400 1.664 E-05 W cm-2

Table 2: Calculated photochemical source radiances

Wavelength

(nm)

Storage Transport

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6.0 Specifications and electrical ratings (EMC)

The Keeler TonoCare is a medical electrical instrument. The instrument requires

special care concerning electromagnetic compatibility (EMC). This section describes the

suitability in terms of electromagnetic compatibility of this instrument. When installing

or using this instrument, please read carefully and observe what is described here.

Portable or mobile-type radio frequency communication units may have an adverse

effect on this instrument, resulting in malfunctioning.

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6.0 Specifications and electrical ratings (EMC) (continued)

Guidance and manufacturer’s declaration – electromagnetic immunity

The Keeler TonoCare is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment.

Immunity test IEC 60601 Test level Compliance level Electromagnetic environment - guidance

Electrostatic

discharge (ESD).

IEC 61000-4-2

Electrical fast

transient/burst.

IEC 61000-4-4

Surge.

IEC 61000-4-5

Voltage dips

IEC 61000-4-11

Voltage Interruptions

IEC 61000-4-11

Power frequency

(50/60 Hz) magnetic

field. IEC 61000-4-8

± 8 kV contact

± 15 kV air

± 2 kV for power supply lines

± 1 kV for input/output lines

± 1 kV line(s) to neutral ± 1 kV line(s) to neutral Mains power quality should be that of a typical

<5% U

(> 95% dip in UT) for 0.5 cycle

<5% U

(> 95% dip in UT) for 1 cycle

40% U

(60% dip in UT ) for 5 cycles

70% U

(30% dip in UT ) for 500ms

<5% U

(>95% dip in UT) for 5s

3 A/m 3 A/m Power frequency magnetic fields should be at a

± 2 kV for power supply lines

± 1 kV for input/output lines

100kHz repetition frequency

At 0°, 45°, 90°, 135°, 180°, 225°,

± 8 kV contact

± 15 kV air

0 % UT; 0,5 cycle

270° and 315°

0 % UT; 1 and 5 cycles

and

70 % UT; 25/30 cycles:

Single phase: at 0°

0 % UT for 250/300 cycles

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Mains power quality should be that of a typical commercial or hospital environment.

commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment.

If the user of the Keeler TonoCare requires continued operation during power mains interruptions, it is recommended that the instrument be powered from an uninterruptible power supply.

level characteristic of a typical location in a typical commercial or hospital environment.

Note UT is the a.c. mains voltage prior to application of the test level.

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6.0 Specifications and electrical ratings (EMC) (continued)

Guidance and manufacturer’s declaration – electromagnetic emissions

The Keeler TonoCare is intended for use in the electromagnetic environment specified below. The customer or user should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions

CISPR 11

RF emissions

CISPR 11

Harmonic emissions

IEC 61000-3-2

Voltage fluctuations /

flicker emissions

IEC 61000-3-3

Group 1

Class B

N/A, Class A < 75W

The Keeler TonoCare uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

The Keeler TonoCare is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

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6.0 Specifications and electrical ratings (EMC) (continued)

Guidance and manufacturer’s declaration – electromagnetic immunity

The Keeler TonoCare is intended for use in the electromagnetic environment specified below. The customer or user should assure that it is used in such an environment.

Immunity test IEC 60601 Test level Compliance level Electromagnetic environment - guidance

Portable and mobile RF communications equipment should be used no closer to any part of the Keeler TonoCare, including cables, than the recommended separation distances calculated from the equation applicable to the frequency of the transmitter.

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

Note 1 At 80MHz and 800MHz, the higher frequency range applies. Note 2 These guide lines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,

objects and people. ¹ Field strengths from fixed transmitters, such as base stations ( cellular / cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Keeler TonoCare is used exceeds the applicable RF compliance level above, the Keeler TonoCare should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orientating or relocating the Keeler TonoCare. ² Over the frequency range 150kHz to 80 MHz, field strengths should be less than 3 V/m.

3 Vrms

150 kHz to 80 MHz

3 V/m

80MHz to 2.7GHz

3 V

3 V/m

Recommended separation distance d = 1.2 √ p d = 1.2 √ p 80MHz to 800 MHz d = 2.3 √ p 800MHz to 2.5GHz

Where p is the maximum output power rating of the transmitter in watts(W) according to the transmitter manufacturer and d is the recommended separation distance in metres(m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey¹, should be less than the compliance level in each frequency range.²

Interference may occur in the vicinity of equipment marked with the following symbol:

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6.0 Specifications and electrical ratings (EMC) (continued)

Recommended separation distances between portable and mobile RF communications equipment and the Keeler TonoCare

The Keeler TonoCare is intended for the use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Keeler TonoCare can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Keeler TonoCare as recommended below, according to the maximum output power of the communications equipment.

Rated maximum

output power of

transmitter

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.74

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

objects and people.

50 kHz to 80MHz

d = 1.2√ p

Separation distance according to frequency of transmitter

80MHz to 800MHz

d = 1.2√ p

800MHz to 2.5GHz

d = 2.3√ p

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7.0 Accessories and warranty

Accessories supplied with the TonoCare

Part Number Description

2418-P-5002 TonoCare docking station

2418-P-5021 Wall mounting kit

2418-P-7000 Forehead rest

EP29-32777 Power supply

Part Number Description

2208-L-7008 Printer paper roll

EP79-40370 USB cable (docking station to PC)

2415-P-7007 Instruction for Use and TonoCare Export App on USB device

TonoCare warranty

The TonoCare and its components are covered by warranty

that they meet their performance standards and are free from

any defects in materials or workmanship. Within 2 years from

delivery by Keeler, the manufacturer shall at no charge to the

customer, upon written notice from the customer, repair or

replace any components which are defective in material or

workmanship.

The customer agrees that it shall have no remedy in the event

The obligations of the manufacturer as set forth in this warranty

are expressly conditioned on the following:

(i) No alterations or repairs of any malfunction of the system

shall be made to the system except by the manufacturer or his

authorized representative, without the prior written approval

of the manufacturer or his authorized representative (and in no

case will the manufacturer assume responsibility for repairs or

alterations made by those other than the manufacturer or his

authorized representative).

of any breach of the foregoing warranty other than as provided

above. This warranty is exclusive, and in lieu of all other

warranties, expressed or implied, and all implied warranties of

merchantability or fitness for a particular purpose are expressly

disclaimed.

And (ii) The customer shall give notice to the manufacturer or

their authorized representative of any malfunction of the system

and shall not use the system for

any diagnostic purpose thereafter.

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8.0 Contact, packaging and disposal information

Keeler Ltd Clewer Hill Road Windsor Berkshire SL4 4AA United Kingdom

Freephone: 0800 521251 Tel: +44 (0) 1753 857177 Fax: +44 (0) 1753 827145

Keeler Instruments Inc. 3222 Phoenixville Pike #50 Malvern PA 19355 United States

Toll Free: +1 800 523 5620 Tel: +1 610 353 4350 Fax: +1 610 353 7814

Disposal of old Electrical and Electronic Equipment

(Applicable in the European Union and other European Countries with

separate collection systems)

This symbol on the product or its packaging indicates that it was put

on the market place after August 2006, and that this product shall

not be treated as household waste.

To Reduce the Environmental impact of WEEE (Waste Electrical Electronic

Equipment) and minimise the volume of WEEE entering landfills we

encourage at Product end of life that this Equipment is recycled and reused.

0088

EP59-70038 Issue F

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Keeler Tonocare User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual