Keeler KAT User manual

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Instructions for use
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Keeler Applanation Tonometer (KAT)

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Contents
1. Introduction
1.1 Brief description of the instrument
1.2 Intended use / purpose of instrument
1.3 How the intraocular pressure is measured
1.4 Advantages of using a Goldmann Tonometer
2. Symbols used
3. Safety
3.1 Standards applied
3.2 Warnings and Cautions
4. Cleaning and disinfection instruction
4.1 Cleaning Tonometer body
4.2 Disinfecting the Tonometer prisms
5. Tonometer Prism field check
6. Name of components of R type and T type KAT
7. Measurement procedure
7.1 Installation on to the Slit Lamp
7.1.1 Keeler Applanation Tonometer (T type)
7.1.2 Applanation Tonometer ‘Keeler Fixed’ (R type)
7.2 Preparing the patient
7.3 Preparing the Slit Lamp instrument for examinations
at 10 x magnification
7.4 Using the instrument/ taking a measurement
7.4.1 Instructions to the patient
7.4.2 Taking the measurement
8. Problem solving
9. General information and suggestions concerning measurement
10. Astigmatism
11. Routine instrument maintenance
11.1 Check procedure with the measurement drum set to 0
11.2 Check procedure with measurement drum set to 2
11.3 Check procedure with the calibration arm set to 6
12. Servicing and calibration
13. Specifications
13.1 Transport, storage and working conditions
13.2 Technical specifications
14. Accessories and warranty
15. Contact information
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As part of our policy for continued product development we reserve the right to amend specifications at any time without prior notice.

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1. Introduction
Thank you for choosing this Keeler Applanation Tonometer (KAT).
Please read this manual carefully before using your KAT.
This will ensure the safety of the patient and your confidence
in the measurements it provides. This manual should be stored
safely for future use.
1.1 Brief description of the instrument
The Keeler Applanation Tonometer operates according to the
“Goldmann method”, by measuring intraocular pressure from the
force required to flatten (applanate) a constant area (3.06mm) of
the cornea. A special disinfected (or single use) prism is mounted
on the Tonometer head and then placed against the cornea.
The examiner, using a slit lamp biomicroscope at 10x
magnification, with a blue filter views two fluorescing green
semi circles. The force applied to the Tonometer head is then
adjusted using the dial until the inner edges of these green
semi-circles meet.
Because physical contact with the cornea takes place it is
necessary to apply to the patients cornea a suitable topical
anaesthetic.
1.2 Intended use /
purpose of instrument
The Keeler Applanation Tonometer is
indicated for measuring intraocular pressure to
aid in the screening and diagnosis of glaucoma.
The Keeler Applanation Tonometer (KAT) is
an accessory item for most ‘Tower Illumination’
type of Slit Lamps and thanks to its versatility,
the KAT Tonometer can be mounted on
and used with slit lamps produced by
many manufacturers.
The KAT should be used only by trained personnel. USA Federal
law restricts this device to sale by or order of a physician.
The manufacturer declines any and all responsibility and warranty
coverage should the instrument be tampered with in any manner
or should routine maintenance be omitted or performed in
manners not in accordance with these manufacturer’s instructions.
R type (fixed) KAT on Slit Lamp

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1. Introduction
1.3 How the intraocular pressure is measured
The cornea is flattened by an acrylic measuring prism on a
ring support at the end of the Tonometer sensor arm assembly.
It is flat with smooth or rounded margins to avoid any damage
to the cornea.
The measuring prism is brought into contact with the patient’s
eye by moving the slit lamp forward. The measurement drum is
then turned to increase the pressure on the eye until a continuous,
uniform applanated surface 3.06 mm in diameter (7,354 mm² area)
is obtained. The doubling prism divides the image and presents
the two opposing semicircular halves at 3.06mm (see section 7.4.2
Measurement procedure for further details).
1.4 Advantages of using a Goldmann Type Tonometer
• Intraocular pressure can be measured during routine
examination with the Slit Lamp.
• The standard deviation among single measurements is
approximately < _ 0,5 mmHg.
• The value is expressed in mmHg and is read directly on the
instrument.
• Scleral rigidity need not be taken into consideration because
the small volume moved (0,56 mm3) increases intra-ocular
pressure by only about 2.5%.
• There are no difficulties as regard standardisation and
calibration.
Position of the
measurement drum
Force
mN
Pressure
kPa mmHg
19.81 1.33 10
2 19.62 2.66 20
3 29.43 39.9 30
4 39.24 53.2 40
5 49.05 66.5 50
6 58.86 79.8 60
7 68.67 93.1 70
8 78.48 10.64 80
Relationship between the pressure of the
measurement drum and the force and
pressure on the applanated surface.
The intra-ocular pressure, expressed in
mmHg, is calculated by multiplying the
drum measurement by ten (for conversion
from one unit to another).

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2. Symbols used
Read user instructions for Warnings, Cautions and
additional information
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
Consult instructions for use
Manufacturers name and address
Keep dry
Fragile
Material suitable for recycling
0088

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3. Safety
Use this instrument only in strict accordance with the
instructions contained in this manual.
3.1 Standards applied
The Keeler Applanation Tonometer is designated as Class I
non-invasive measuring device under EC Directive 93/42/EEC for
medical equipment products.
The CE mark on this product indicates it has been tested to
and conforms to the provisions noted within the 93/42/EEC
Medical Device Directive.
It also complies with ISO 15004-1:2006 ophthalmic instruments-
Fundamental requirements and test methods and BS EN ISO
14971:2007 Medical Devices - Application of Risk Management
to Medical Devices.
Classification
CE Regulation 93/42 EEC: Class 1m (Measuring function)
FDA: Class II

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3. Safety
3.2 Warnings and Cautions
• The owner of the instrument is responsible for training
personnel in its correct use.
• Accuracy of applanation 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 the product if visibly damaged and periodically
inspect for signs of damage or misuse.
• The contact surface of this prism should be checked before
each use for damage and discarded if damage is found.
• We recommend that the prism is not used when it becomes
more than two years of age as, after this time it is possible
that body or sterilising fluids may seep inside leading to
possible sterility and cross contamination issues.
• Only decontaminate / clean in accordance with method given
in Cleaning Section 4 of this instruction manual.
• Use only cloths dampened with water to clean the
Applanation Tonometer body. Do not use corrosive products
or alcohol.
• Keeler Applanation Tonometers should be serviced and
calibrated annually. Any servicing or repairs/modifications
should only be carried out by Keeler Ltd. or by suitably
trained and authorised distributors. The manufacturer declines
any and all responsibility for loss and/or damages resulting
from unauthorised repairs; furthermore, any such actions will
invalidate the warranty.
• Never use the instrument if the ambient temperature,
atmospheric pressure, and/or relative humidity are outside the
limits specified in this manual.
• Should the instrument suffer shocks (for example, should it
accidentally fall), follow the check procedure outlined in the
“Calibrations” section 12 ; if necessary, return the
instrument to the manufacturer for repair.
• Use only the listed accessories in conjunction with the
instrument; use said accessories only in accordance with the
procedures set forth in the instruction manuals.
• Always carefully observe the safety rules and other
precautions published herein.

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4. Cleaning and disinfection instruction
4.1 Cleaning Tonometer body
• Only manual non-immersion cleaning as described should be
used for this instrument.
• 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).
• Use caution to ensure cloth is not saturated with solution.
• Surfaces must be carefully hand-dried using a clean
non-shedding cloth.
• Safely dispose of used cleaning materials.

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4. Cleaning and disinfection instruction
4.2 Disinfecting the Tonometer prisms
Always disinfect the Tonometer prisms before use. Hand hygiene
must be considered to prevent any contamination.
1Carefully remove the
Tonometer prism from
the prism holder.
2Wash the Tonometer prism
under cold running water for
approximately 1 minute, to
ensure Tonometer prism
is physically clean before
exposed to disinfection
process.
3Immerse the Tonometer prism
in the disinfectant fluid. Types
of disinfectant fluid vary.
4Rinse the disinfectant from
the prism in running water
for between 10 and 30
minutes.
5Dry the disinfected
Tonometer prism with a
clean soft cloth.
6Store the Tonometer prism in a
suitable container ready for use.
Safely dispose of the
disinfectant fluids used.
Please follow disinfectant solution guidelines for instructions, concentration and
time of immersion. (For example: Pantasept - 3% aqueous solution for 10 minutes,
Hydrogen Peroxide 3% aqueous solution for 10 minutes, Sodium Hypochlorite,
10% aqueous solution for 10 minutes etc.).
Do not disinfect using
the following:
Alcohol, Acetone, UV radiation,
Sterilisation, Immersion in fluid for
more than one hour,
Temperatures greater than 60°C
1 min
10 mins
10-30
mins

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5. Tonometer Prism field check
Check Tonometer prism under Slit lamp and ensure there is no
cracks/chips. Chemical used in diagnosis process (for example:
Fluorescein) will get into the cracks and will show up if observed
under slit lamp. Do not use it if there is any sign of crack or chip.