Haag-Streit Perkins Mk3 Instruction Manual

Haag-Streit Perkins Mk3 Instruction Manual

Hand-held applanation tonometer

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Perkins Mk3
Hand-Held
Applanation Tonometer
Instruction Manual
Please read these instructions
before using the equipment
0120
CLEMENT CLARKE
OPHTHALMIC

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Summary of Contents for Haag-Streit Perkins Mk3

  • Page 1 Perkins Mk3 Hand-Held Applanation Tonometer Instruction Manual Please read these instructions before using the equipment 0120 CLEMENT CLARKE OPHTHALMIC...
  • Page 2: Table Of Contents

    ......15 5.1 Remove Perkins Mk3 Tonometer From Case ..... . 15 5.2 Doubling Prism .
  • Page 3: Introduction

    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.
  • Page 4: Indications For Use

    Purpose for use The Perkins Mk3 Tonometer is an essential tool used in the global examination of all eye check-ups and specifically for a glaucoma examination, these tests together 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.
  • Page 5: General Layout

    2. General Layout Fig 1 Forehead rest Forehead rest locking screw Forehead rest stem Prism holder Doubling prism Illumination LEDs...
  • Page 6: General Layout

    2. General Layout - continued Fig 2 Viewing lens Milled thumb-wheel Scale Tonogrip (Cone arm securing buttons) Battery Indicator Charging Port...
  • Page 7: Safety And Regulatory Information

    3. Safety and Regulatory Information 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.
  • Page 8: Measuring Prism Replacement

    • HAAG-STREIT therefore recommend strongly that no measuring prism is used beyond two years from it’s date of first usage (a measuring prism may be retained as a spare indefinitely - deterioration does not start until it is first used).
  • Page 9: Transportation And Storage

    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. • The Perkins Mk3 should not be used while connected to the battery charger.
  • Page 10: Statutory Requirements

    3. Safety and Regulatory Information - continued Statutory Requirements • The Applanation Tonometer is designed as a Class IIa device under the Medical Device Directive 93/42/EEC. • The Applanation Tonometer complies with the Tonometer regulation ISO 8612:2009 & ISO 15004-1: 2006. Caution •...
  • Page 11: Waste Electrical Electronic Equipment (Weee)

    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 01279 414969, who will instruct you how to return the device for disposal. Environmental Conditions of Use Temperature: +10ºC to +35ºC...
  • Page 12: Emc (Electromagnetic Compatibility) Declaration

    Nevertheless, special precautions need to be observed: The use of accessories and cables other than those specified by Haag-Streit-UK Ltd, with the exception of cables sold by Haag-Streit-UK Ltd as replacement parts for internal components, may result in increased emission or decreased immunity of the device.
  • Page 13: Product Labelling And Safety Symbols

    The labels affixed to the equipment are there to remind you of safety precautions. Do not remove these labels. Safety Symbols The Perkins Mk3 Tonometer and its labels include the following markings: Caution (Consult ‘Instructions for use’) This product complies with the essential requirements of the medical devices directive (93/42/EEC).
  • Page 14: Taking A Pressure Measurement

    The inner border of the ring represents the line of demarcation between the cornea flattened by applanation and the cornea HAAG-STREIT BERN not flattened. Fig 3 Comparative scale...
  • Page 15: Taking A Pressure Measurement

    4. Taking a Pressure Measurement - continued The major advantage of applanation tonometry is the small bulbous deformation that amounts to only 0.56 mm . The values found by this method of tonometry are only slightly influenced by scleral rigidity and radius of corneal curvature. Nevertheless, in order to obtain exact results, the method of use indicated must be strictly followed.
  • Page 16: To Prepare The Prism For Use

    5. To Prepare the Prism for Use Remove Perkins Mk3 Tonometer from case Remove the Perkins tonometer from the carrying case by holding the main body. Under no circumstances should it be lifted by the prism holder (Fig 1, 4).
  • Page 17: Operating The Equipment

    Regular calibration of the Tonometer is advised. Do not use without prism fitted. It is recommended that only Haag-Streit original Goldmann prisms or Tonosafe are used. Preparing the Patient 1. Both eyes must always be anaesthetized (e.g. 2-3 drops each of an anaesthetic within half a minute) to reduce movements of the lids during examination.
  • Page 18: Instruction To The Patient

    Preparing the Patient - continued When seen through the viewing lens (Fig 2, 7) the semicircles of fluorescein should now be clearly visible and appear equal in size, denoting that the contact point is central on the cornea. The light is switched off by turning the thumb-wheel until the scale reading (Fig 2, 9) is below zero.
  • Page 19: Cleaning The Equipment

    7. Cleaning the Equipment Cleaning (manual) – non-immersion for Ophthalmic medical devices. Scope of Action Non-immersion manual cleaning methods are appropriate for low risk items (those items that come into contact with intact skin or do not contact the patient) where soaking in aqueous solution, e.g.
  • Page 20: General Notes

    8. General Notes Note Only the shortest possible measuring time periods should be carried out on each eye. Should drying of the cornea epithelium be observed, then vision and field of sight should be checked in advance. The measuring procedure can be repeated several times. Excited or anxious patients often display a higher ocular pressure during the first measurement.
  • Page 21: To Use The Instrument On Animals

    Astigmatism - continued For example If the corneal astigmatism amounts to 6.5 mm/ 30˚ = 52.0 D/30˚ and 8.5 mm/120˚ = 40.0 D/120˚ the graduation value 120˚ of the prism is set at the 43˚ mark of the prism holder. If there is a corneal astigmatism of 8.5mm/30˚...
  • Page 22: Measurement

    9. Measurement Measurement of the force necessary to flatten a corneal surface of constant (ø 3.06mm) size. Dial indicator Force Pressure 9.81 mN 1.33 kPa = 10mm Hg too light applanation correct applanation too heavy applanation Fig 7 decentred Adjust the force by turning the thumb-wheel (Fig 2, 8) until the inner margins of the semicircles coincide (Fig 7).
  • Page 23 9. Measurement - continued Note 1. Immediately before taking the measurements, The following are schematically simplified the patient should be made to close the eyes briefly so that the cornea becomes sufficiently illustrations! moistened with the lacrimal fluid and fluorescein. 2.
  • Page 24: Sources Of Error

    Sources of Error 4.5.1 Fluorescein ring / Distance to the patient Result Image in ocular Cause Correction The fluorescein ring The measuring prism was The tonometer should be is too wide not dried after cleaning, withdrawn and the meas- or the eyelids came into uring prism dried with a contact with the cotton wool swab.
  • Page 25: Inaccurate Horizontal Centering

    Inaccurate Horizontal Centering Result Image in ocular Cause Correction The upper semi The measuring prism is Move the tonometer to circular ring appears not focused on the eye. the right. partly The eye is too far on the right. The upper semi The measuring prism is Move the tonometer to circular ring appears...
  • Page 26: Inaccurate Vertical Centering

    Inaccurate Vertical Centering Result Image in ocular Cause Correction A semi circular ring The measuring prism is Move the tonometer appears partly in the not focused on the eye. upwards. upper half The eye is too far up. The ring appears The measuring prism is Move the tonometer completely in the...
  • Page 27: Inaccurate Pressure

    Inaccurate Pressure Result Image in ocular Cause Correction The outer edges of Pressure is too strongly Increase the pressure by the fluorescein rings reduced turning the milled thumb touch each other wheel. The fluorescein rings The pressure is reduced Increase the pressure by coincide and form a turning the milled thumb line...
  • Page 28: Case Contents

    10. Case Contents Perkins Tonometer Mk3 Five-gram weight Forehead Rest Battery Charger Doubling Prism/Black Tonosafe Holder Adaptor (UK, US, EU) Two-gram weight Setting Block Fig 14...
  • Page 29: Calibration Check

    11. Calibration Check Regular calibration of the Tonometer is advised. Please see 7.3 Special Precautions Proceed as follows:- 1. Insert the doubling prism (Fig 1, 5) into the prism holder (Fig 1, 4). Check for zero position 2. Adjust the milled thumb-wheel (Fig 2, 8) so that the scale reading is below zero by the full thickness of one scale line.
  • Page 30: Storage Of Prism And Tonometer

    11. Calibration Check - continued Check at the 5 g position 6. Repeat the process as described in 4. and 5. above, but using the 5 mark on the scale and a setting one-and-a-half lines width above and then below the 5 mark and with the 5 g weight on the prism cone.
  • Page 31: Charging The Battery

    2116 manufactured by Mascot AS in Norway. 14. Battery Pack The Perkins Mk3 Tonometer is powered by a 3.6V Ni MH chargeable battery pack that will last for approx. 25 hours. The battery indicator LED (Fig 2, 11) indicates: green...
  • Page 32: Charger Unit

    15. Charger Unit The charger unit has a 3 coloured LED ( yellow, orange and green ) that flashes 6 different modes (see printing on charger). When the Tonometer is first plugged into the battery charger, the battery charger LED will show orange for several seconds while it gives a short charge to the Tonometer battery.
  • Page 33: References

    References Perkins ES: Hand-held applanation tonometer. Br J Ophthalmol 1965 49 591. Perkins ES: Tonometry in experimental animals. Evaluation of Drug Effects on the Eye 1968 43-47. Heid S and Flament J: Aplanotonométrie à main. Bulletin des Sociétés d’Ophtalmologie de France 1968 68 655. Flament J: Aplanotonométrie à...
  • Page 34: Accessories

    Catalogue Description Number 5806000 Standard device, comprising - The Perkins hand-held tonometer, doubling prism, patient’s forehead rest, instruction manual and Certificate of Accuracy. The setting block and weights (5g and 2g) are also carried in the case provided. Accessories Catalogue Description Number 5806030...
  • Page 35 For the full IFU (Instructions for use) see Haag-Streit UK website www.haagstreituk.com/ifu Haag-Streit UK Ltd., Edinburgh Way, Harlow, Essex CM20 2TT UK Tel: +44 (0)1279 414969 Fax: +44 (0)1279 635232 Patented in Great Britain & countries throughout the world Instruction Manual no: 1902538...

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