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CLEMENT CLARKE OPHTHALMIC

Perkins Mk3

Hand-Held

Applanation Tonometer

Instruction Manual

Please read these instructions

before using the equipment 0120

Manuel d'instructions

Bedienungsanleitung

Manuale di istruzioni

Manual de instrucciones

1639

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Page English.............................................................. 3 French............................................................... 36 German............................................................. 69 102
Spanish............................................................. 13 5 en ..................................................................... 3 fr ....................................................................... 36 de ..................................................................... 69 it ....................................................................... 102 es ...................................................................... 135

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Contents

1. Introduction

4

1.1 Technical Description . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . 4

1.2a Indications for use . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . 5

1.2b Purpose for use . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . 5

1.3 Brief Description of the Appliance . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . 5

2. General Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . 6

3. Safety and Regulatory Information . . . . . . . . . . . . . . . . . . . . . . . . 8

3.1 Safety Notices . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . 8

3.2 Measuring Prism Replacement . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . 9

3.3 Transportation and Storage . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . 10

3.4 Notes on Usage . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . 10

3.5 Statutory Requirements . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . 11

3.6 Caution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . 11

3.7 Regulatory Information: CE Mark . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . 11

3.7.1 Waste Electrical Electronic Equipment (WEEE). . . . . . . . . .

. . . . . . . . . . 12

3.8 Environmental Conditions of Use . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . 12

3.9 (Electromagnetic Compatibility) Declaration. . . . . . . . . . . .

13

3.10 Product Labelling and Safety Symbols . . . . . . . . . . . . . . .

. . . . . . . . . . 14

3.11 Safety Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . 14

4. Taking a Pressure Measurement . . . . . . . . . . . . . . . . . . . . . . . . . 15

5. To Prepare the Prism for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

5.1 Remove Perkins Mk3 Tonometer From Case . . . . . . . . . . . . . . .

. . . . . . . 17

5.2 Doubling Prism . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . 17

5.3 To Insert Prism into Prism Holder . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . 17

5.4 Tonosafe Disposable Prism . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . 17

6. Operating the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

6.1 Preparing the Patient . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . 18

6.2 Instruction to the Patient . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . 19

7. Cleaning the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

8. General Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . 21

8.1 Astigmatism . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . 21

8.2 To Use the Instrument on Animals . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . 22

8.3 Special Precautions . . . . . . . . . . . . . . . . . . . . . . . .

22

9. Measurement

23

9.1 Sources of Error . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . 25

9.2 Inaccurate Horizontal Centering . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . 26

9.3 Inaccurate Vertical Centering . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . 27

9.4 Inaccurate Pressure . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . 28

10. Case Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . 29

11. Calibration Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 30

12. Storage of Prism and Tonometer . . . . . . . . . . . . . . . . . . . . . . . . .

31

13. Charging the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

14. Battery Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

32

15. Charger Unit

33
33

References

34

Accessories

35

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1. Introduction

We would like to thank you for your decision to purchase this CLEMENT CL

ARKE product.

product will give you reliable and trouble-free usage. We will be forced to disclaim any warranty and liability if the instrume nt is altered in any way or if routine maintenance is neglected or not carried out accord ing to fac- Only original CLEMENT CLARKE accessories are to be used to ensure contin ued reliability of the instrument.

Following the popular Mark 2 Perkins tonometer, comes the technically advanced and well designed Mark 3 model. Its improved LED illumination and convenience are some of the many features which maintain the reputation of Perkins hand-held instruments in the forefront of tonometry.

Because the

Perkins

tonometer is capable of being used in all positions, the mass of the Goldmann doubling prism must be controlled accurately. Only HAAG-STREIT prisms should be used or the disposable Tonosafe prism can be used to prevent cross-infection. Any other prisms may give a false reading if used in the Perkins tonometer.

1. 1 Technical Description

by rotation of the operator's calibrated thumb-wheel. The resulting force stored in the spring is transmitted through a balanced arm to the applanation doubling prism or the

Tonosafe prism mounted at its end.

vide illumination. These are powered by a 3.6V, 280 mAh Ni-Mh rechargeable b attery. The LED meets the requirements for a Class 1 LED product to IEC/EN 60825 -1 (2001) under normal operating conditions and those of single fault fai lure. The battery charger conforms to Class II insulation and has also been te sted to

EN60601 and UL60601-1.

This equipment is designed and manufactured to be as safe as is reasonab ly practicable manufacturer's instructions. Any misuse, incorrect assembly or instal lation could result in the equipment becoming unsafe. It must not be repaired except by compete nt persons under the manufacturer's instructions.

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1. Introduction - continued

1. 2a Indications for use

The Perkins Mk3 Tonometer is used to measure intraocular Pressure (IOP) which is 1.

2b Purpose for use

The Perkins Mk3 Tonometer is an essential tool used in the global examination of give a complete picture of the patient's ocular health and are therefore important in understanding the risks of developing and/or controlling diseases such as cataracts, macular degeneration, or glaucoma. The following tests make up a glaucoma examination:

1. 3 Brief Description of the Appliance

The Applanation Tonometer functions according to the "Goldmann" method: The measuring of the pressure required to maintain a uniform applanation of the surface of the cornea. by ten. displacement of 0.56 mm

3 increases the intraocular tension by about

2.5% only.

Hospital and Optician use only

Caution: Federal Law restricts this device to sale by or on the order of a physician.

Caution: ќ

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1. Introduction - continued

1. 2a Indications for use

The Perkins Mk3 Tonometer is used to measure intraocular Pressure (IOP) which is 1.

2b Purpose for use

The Perkins Mk3 Tonometer is an essential tool used in the global examination of give a complete picture of the patient's ocular health and are therefore important in understanding the risks of developing and/or controlling diseases such as cataracts, macular degeneration, or glaucoma. The following tests make up a glaucoma examination:

1. 3 Brief Description of the Appliance

The Applanation Tonometer functions according to the "Goldmann" method: The measuring of the pressure required to maintain a uniform applanation of the surface of the cornea. by ten. displacement of 0.56 mm

3 increases the intraocular tension by about

2.5% only.

Hospital and Optician use only

Caution: Federal Law restricts this device to sale by or on the order of a physician.

Caution:

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2. General Layout

Fig 1 1

Forehead rest

2

Forehead rest locking screw

3

Forehead rest stem

4

Prism holder

5

Doubling prism

6

Illumination LEDs

1 2 4 3 5 6

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2. General Layout - continued

Fig 2 7

Viewing lens

8 Milled thumb-wheel

9 Scale

10 Tonogrip

(Cone arm securing buttons)

11 Battery Indicator

12 Charging Port

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3. Safety and Regulatory Information

3. 1 Safety Notices

No user serviceable parts inside.

Do not open the Tonometer case moulding under any circumstances. Caution: In the event of any malfunction, contact your local distributor or visit our website to contact us directly.

Use only the charger supplied with the device.

The operator should not touch the accessible charger connector and the patient simultaneously.

This product is intended for indoor use only.

anaesthetic mixture with air or with oxygen or with nitrous oxide. The following instructions should be observed to ensure the safety of patients: Avoid examinations in cases of eye infections or injured corneas is necessary and due care is to be exercised in cases of eye infections and injuries to the cornea. Only clean and disinfected measuring prisms should be used prisms. disinfected before use.

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3. Safety and Regulatory Information - continued

No damaged prisms should be used

Before each use the contact surface of all prisms should be checked for contamination or damage (such as scratching, rips or sharp edges). of 10x to 16x. patient's eye while tonometry is taking place, leading to irritation of the cornea. Defective measuring prisms should not be used, to avoid any damage to th e patient's cornea. 3.

2 Measuring Prism Replacement

material used, number of patients, handling etc. - it is almost impossib le to put a safely be used for. per the instructions contained within this instruction manual) a maximu m of two years provides an adequate safety factor. this time period - damaged prisms should be immediately discarded. Incorrect medical disinfecting can cause patients to be infected and ca n also cause damage to the eyes. therefore rinse throughly.

Applied Parts

Tonosafe Disposable Prism

Goldmann Doubling Prism

Head Rest

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3. Safety and Regulatory Information - continued

3.

3 Transportation and Storage

Transport Conditions and should always be stored in its carry case when not in use.

Transport Conditions

Relative Humidity: 10% to 95%

Atmospheric Pressure: 500hPa to 1060hPa

Vibration, Sinusoidal: 10Hz to 500Hz: 0.5g

Shock: 30g, duration 6 ms

Bump: 10g, duration 6 ms

Storage Conditions

Relative Humidity: 10% t0 95%

Atmospheric Pressure: 1060hPa

according to the corresponding operating instructions.

Transport Conditions only within the carry case.

3.

4 Notes on Usage

to external force (e.g. unintentional shocks or being allowed to fall) and if necessary, should be returned to the manufacturer for repair. resulting from unauthorized intervention. In particular, it is forbidden to loosen any screws; this may reduce the accuracy of the measurement. All ensuing warranty claims will be deemed null and void as a result of unauthorized intervention.

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3. Safety and Regulatory Information - continued

3.

5 Statutory Requirements

IIa device under the Medical

Device Directive 93/42/EEC.

ISO 8612:2009 & ISO 15004-1: 2006.

3.

6 Caution

observed with special care.

Caution

Strictly observe all warning notices!

3. 7 Regulatory Information: CE-Mark

standards: Safety: EN60601-1 Part 1: General Requirements for Safety,

Medical Electrical Equipment

Electrical: EN60601-1-2 Part 2: Collateral Standard: Electromagnetic

Compatibility

Infrared: EN60825-1 Part 1: Safety of Laser Products: Equipment

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3. Safety and Regulatory Information- continued

3. 8 Environmental Conditions of Use

Temperature: +10ºC to +35ºC

Relative Humidity: 30% to 90%

Atmospheric Pressure: 800hPa to 1060hPa

Shock ( without packing): 10g, duration 6 ms

3. 7.1 Waste Electrical Electronic Equipment (WEEE)

End of Life and Disposal

The battery may contain toxic or hazardous material and must be disposed of as

Waste Electrical Electronic Equipment (WEEE).

For all applicable devices under the WEEE directive, which have reached their end of life, please contact Haag-Streit customer services on +44 (0) 1279 414969, who will instruct you how to return the device for disposal.

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3. Safety and Regulatory Information - continued

3. 9 (Electro Magnetic Compatibility) Declaration

With the increased number of electronic devices such as PC's and mobi les, med- ical devices in use may be susceptible to electromagnetic interference f rom these devices. Which may result in incorrect operation of the medical device a nd create a potentially unsafe situation. Medical devices should also not interfer e with other devices. In order to regulate the requirements for with the aim to prevent un safe product the levels of immunity to electromagnetic interferences as well as maxim um levels of electromagnetic emissions for medical devices. Medical devices manufactured by Haag-Streit-UK Ltd conform to this EN606

01-1-2

standard for both immunity and emissions. Nevertheless, special precautions need to be observed: with the exception of cables sold by Haag-Streit-UK Ltd as replacement p arts for internal components, may result in increased emission or decreased immun ity of the device. The medical devices should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is unavoidable, the medical device should be seen to operate normally as it should in this situation. Further guidance regarding the environment (in accordance with EN60601-1-2) in which the device should be used is available at:

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3. Safety and Regulatory Information - continued

3. 10 Product Labelling and Safety Symbols

Do not remove these labels.

3. 11 Safety Symbols

The Perkins Mk3 Tonometer and its labels include the following markings: 0120
This product complies with the essential requirements of the medical devices directive (93/42/EEC). (SGS United Kingdom Ltd).

Do not dispose of with household refuse.

Please contact your local authority for your nearset recycling centre.

Manufacturer

Direct Current (D.C.)

Medical Electrical Equipment Type B

2010

Year of Manufacture

e.g. SN0001 T3Serial number Perkins Mk3 Tonometer (Example)quotesdbs_dbs24.pdfusesText_30

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