Haag-Streit Perkins Mk3 Скачать руководство пользователя страница 13 | Manualshive

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Haag-Streit Perkins Mk3 Скачать руководство пользователя страница 13

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en

3. Safety and Regulatory Information -

continued

3.

10

Product Labelling and Safety Symbols

The labels affixed to the equipment are there to remind you of safety precautions.

Do not remove these labels.

3.

11

Safety Symbols

The Perkins Mk3 Tonometer and its labels include the following markings:

!

Caution (Consult ‘Instructions for use’)

0120

This product complies with the essential requirements of the

medical devices directive (93/42/EEC).

Compliance has been verified by UK notified body per 0120

(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 T3

Serial number Perkins Mk3 Tonometer (Example)

Consult ‘Instructions for use’

Off Power

On Power

Storage & Transport

On / Off

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Содержание Perkins Mk3

Страница 1: ...Perkins Mk3 Hand Held Applanation Tonometer Instruction Manual Please read these instructions before using the equipment CLEMENT CLARKE OPHTHALMIC 0120 ...

Страница 2: ...Symbols 12 4 Taking a Pressure Measurement 13 14 5 To Prepare the Prism for Use 15 5 1 Remove Perkins Mk3 Tonometer From Case 15 5 2 Doubling Prism 15 5 3 To Insert Prism into Prism Holder 15 5 4 Tonosafe Disposable Prism 15 6 Operating the Equipment 16 6 1 Preparing the Patient 16 6 2 Instruction to the Patient 17 7 Cleaning the Equipment 18 8 General Notes 19 8 1 Astigmatism 19 8 2 To Use the In...

Страница 3: ...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 A pair of spiral wound flat springs connected in series are progressively tensioned 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 t...

Страница 4: ...p a glaucoma examination medical and ocular history visual acuity testing refraction to measure the glasses or lens correction tonometry testing for IOP 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 The intraocular pressure in mm Hg is ...

Страница 5: ...4 en 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 ...

Страница 6: ...5 en 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 8 9 10 11 12 7 ...

Страница 7: ...nst the ingress of water or other fluids Warning No modification of this equipment is allowed The following instructions should be observed to ensure the safety of patients Avoid examinations in cases of eye infections or injured corneas There is no known contraindication for performing tonometry Medical assessment is necessary and due care is to be exercised in cases of eye infections and injurie...

Страница 8: ...a figure on the number of times and or period of time that a measuring prism can safely be used for Our experience and that of our users indicates that under normal usage i e as per the instructions contained within this instruction manual a maximum of two years provides an adequate safety factor HAAG STREIT therefore recommend strongly that no measuring prism is used beyond two years from it s da...

Страница 9: ... 33 according to the corresponding operating instructions The battery charger is exempt from the above standard but has been tested for Transport Conditions only within the carry case 3 4 Notes on Usage Only qualified and trained personnel may operate the equipment The training of the operating personnel is the responsibility of the equipment user This type of sensitive measuring equipment should ...

Страница 10: ...ety regulations displayed in the operating instructions are to be observed with special care Caution Strictly observe all warning notices 3 7 Regulatory Information CE Mark The products fulfil the requirements according to the following standards Safety EN60601 1 Part 1 General Requirements for Safety Medical Electrical Equipment Electrical EN60601 1 2 Part 2 Collateral Standard Electromagnetic Co...

Страница 11: ...on 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 01279 414969 who will instruct you how to return the device...

Страница 12: ...aximum levels of electromagnetic emissions for medical devices Medical devices manufactured by Haag Streit UK Ltd conform to this EN60601 1 2 standard for both immunity and emissions 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 ...

Страница 13: ... for use 0120 This product complies with the essential requirements of the medical devices directive 93 42 EEC Compliance has been verified by UK notified body per 0120 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 S...

Страница 14: ... ten SI Units according to standard ISO 1000 According to ISO 1000 the derived unit of force is the N Newton and its decimal sub multiple the mN milli Newton The conversion of mm Hg into the SI pressure unit kPa Kilo Pascal can be made on the comparison scale in Fig 3 The measurement of the flattened surface is made directly on the cornea The built in duplication system in the measuring prism divi...

Страница 15: ...re based on the assumption that a cornea with a normal thickness is being measured alteration of the corneal thickness leads to changes in the measured IOP A normal corneal thickness is considered to be within the area of 530 560 microns There is no universally agreed formula for the adjustment of the measured tonometry reading against altered corneal thickness The users should bear these two fact...

Страница 16: ... moves forward Fig 4a pressed and the prism holder out Fig 4b the prism can be pushed into place 2 Gently pinch together the Tonogrip cone arm securing buttons Fig 4a on either side to hold the prism holder in position N B Failure to follow these instructions could result in severe damage being caused to the instrument 5 4 Tonosafe Disposable Prism Alternatively Tonosafe disposable prisms may be u...

Страница 17: ...esthetic fluorescein eye drops can be used When using drops a solution of sodium fluorescein 0 25 to 0 5 is advisable Caution If the prism touches the cornea without any force applied the pressure arm can vibrate and may disturb the patient For this reason the scale is set to read 1 before applying the prism face to the cornea The Perkins tonometer should be held so that the thumb rests on the mil...

Страница 18: ...e optimum fluorescence only when the prism cone is at its calibrated position i e when the rim of the prism holder is level with or not more than 1 mm above the case surface 6 2 Instruction to the Patient Fig 6 Instruct the patient to look straight ahead or slightly upward and if necessary use a fixation light for this purpose It is recommended that patients are repeatedly asked to keep their eyes...

Страница 19: ... it is disconnected from the charger and the unit is switched off pointer reaches just below zero before commencing the cleaning procedure Wearing protective clothing immerse the cleaning cloth in the detergent solution and wring thoroughly Commencing with the upper surface of the item wipe thoroughly ensuring that detergent solution does not enter the electrical components Periodically rinse the ...

Страница 20: ...cedure lasts too long on one eye drying will occur on the cornea epithelium of both eyes A ring of fluorescein positive deposits around the contact positions of the cornea and the measuring element will occur on the eye under examination On the other eye map like fluorescein positive dried places will occur which will not allow a reliable measuring procedure Extensive drying phenomena disappear af...

Страница 21: ... simply by connecting the anterior chamber to a reservoir and taking tonometer readings at different pressure levels In most cases it will be found that the tonometric reading is lower than that obtained for the human eye The eyes of rhesus and cynomolgus monkeys behave very similarly to the human eye but those of the rabbit and cat give lower readings Note If the instrument is used on animals the...

Страница 22: ...the semicircles appear large and are not reduced by diminishing the force of the spring the tonometer has been pushed too close to the eye and withdrawing it slightly will bring the prism within the range of free movement If it is desired to use the Perkins tonometer without any forehead rest the instrument can be steadied by resting the fingers against the patient s malar region while the prism i...

Страница 23: ...tact commence observing the cornea A regular pulsation of the two semi circular fluorescein rings which can be of varying size dependent on the ocular pressure when the measuring drum is at setting 1 will show that the tonometer is in the correct measuring position 4 The pressure on the eye is increased by turning the milled thumb wheel on the tonometer until the edges of both fluorescein rings ju...

Страница 24: ...ntly Should the patient withdraw the head further then the fluorescein rings will disappear altogether Should the tonometer be moved forward towards the patient or should the patient move towards the tonometer whilst the measurement is being taken then the feeler arm will come into contact with a sprung stop piece The applanation surface is then too large The tonometer should be withdrawn and the ...

Страница 25: ... Centering Result Image in ocular Cause Correction The measuring prism is not focused on the eye The eye is too far on the right The measuring prism is not focused on the eye The eye is still too far on the right The measuring prism is focused precisely on the eye The measuring prism is not focused on the eye The eye is still too far on the left The measuring prism is not focused on the eye The ey...

Страница 26: ...he ocular 9 3 Inaccurate Vertical Centering Result Image in ocular Cause Correction The measuring prism is not focused on the eye The eye is too far up The measuring prism is not focused on the eye The eye is still too far up The measuring prism is not focused on the eye The eye is still too far up The measuring prism is not focused on the eye The eye is still too far up The measuring prism is foc...

Страница 27: ...ings touch each other 9 4 Inaccurate Pressure Result Image in ocular Cause Correction Pressure is too strongly reduced The pressure is reduced The pressure is too strongly increased Accurate pressure precise focusing of the measuring prism Increase the pressure by turning the milled thumb wheel Increase the pressure by turning the milled thumb wheel Reduce the pressure by turning the milled thumb ...

Страница 28: ...10 Case Contents 1 Perkins Tonometer Mk3 5 Five gram weight 2 Forehead Rest 6 Battery Charger 3 Doubling Prism Black Tonosafe Holder 7 Adaptor UK US EU 4 Two gram weight 8 Setting Block Fig 14 7 2 3 5 4 8 6 1 ...

Страница 29: ...ness of one scale line Place the instrument on a flat horizontal surface with the setting block under the body and the prism cone upwards as shown in Fig 15 Place the 2 g weight recess downward centrally on the prism cone and check that it carries the prism positively down to its lowest position 5 Also as a rough check set the scale reading above the 2 mark by the full thickness of the scale line ...

Страница 30: ...wnward into the hole in the foam interior of the carrying case Fig 14 3 The tonometer should then be returned to the carrying case Do not pack the Perkins tonometer with the prism still in the instrument Never store the instrument with the spring under load i e return the milled thumb wheel to below zero The suppliers cannot accept responsibility for the performance reliability or safety of this e...

Страница 31: ...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 Fully charged orange Several hours of use left approx red Battery needs to be charged Warning The battery pack requires no maintenance and should give substantial use before replacement is required ...

Страница 32: ...s the Tonometer battery is almost fully charged the battery charger LED switches to green with short flashes of yellow up to 1 hour to complete the charge When the top off charge is complete the battery charger LED will switch to solid green trickle charge indicating the Tonometer battery is fully charged Please Note If after the analysis mode the LED alternately flashes between orange and green t...

Страница 33: ...J Ophthalmol 1971 55 644 646 Dunn JS and Brubaker RF Perkins applanation tonometer clinical and laboratory evaluation Arch of Ophthalmol 1973 89 149 151 Radtke ND and Cohan BE Intraocular pressure measurement in the newborn Am J Ophthalmol 1974 78 501 504 Al Abrak MH and Samuel JR Effects of general anaesthesia on the intraocular pressure in man Br J Ophthalmol 1974 58 806 810 Fujikawa LS Salahudd...

Страница 34: ... Doubling prism 5806028 Battery charging unit 5805100 1 box of 100 prisms and 5 prism holders EU 5805080 1 box of 100 prisms and 5 prism holders USA only 5805091 1 box of 20 Tonosafe prisms 1 Holder 5806046 Adaptor UK 5806047 Adaptor EU 5806048 Adaptor US Whilst the information is provided in good faith and is based on the latest information available at the time of issue this booklet gives only a...

Страница 35: ...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 Issue no 7 09 17 For the full IFU Instructions for use see Haag Streit UK website www haagstreituk com ifu ...

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