Keeler KAT Manual de usuario

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Instructions for use

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

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.

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