Keeler D-KAT Instructions For Use Manual Download Page 2

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Contents

Introduction

1.1 Brief description of the instrument

1.2 Intended use / purpose of instrument

1.3 How the intraocular pressure (IOP) is measured

1.4 Advantages of using a Goldmann type Tonometer

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
7  Switching on / off and configuring the D-KAT

7.1 Switching on / off

7.2 Changing decimal point setting

7.3 Changing the display brightness

7.4 Battery status

8. Measurement procedure

8.1 Installation on to the Slit Lamp

8.2 Preparing the patient

8.3 Preparing the Slit Lamp instrument for examinations

at 10x magnification

8.4 Using the instrument / taking a measurement

8.4.1 Instructions to the patient

8.4.2 Taking the measurement

9.  Problem solving
10.  General information and suggestions concerning measurement
11.  Astigmatism
12.  Routine instrument maintenance

12.1 Check procedure with test arm set to 20

12.2 Check procedure with test arm set to 60

13. Servicing and calibration

13.1 Battery replacement

14. Specifications

14.1 Transport, storage and working conditions

14.2 Technical specifications

15. Accessories and warranty
16. Contact information

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Summary of Contents for D-KAT

Page 1: ...Instructions for use Next Keeler Digital Applanation Tonometer D KAT Z type ...

Page 2: ... the Slit Lamp instrument for examinations at 10x magnification 8 4 Using the instrument taking a measurement 8 4 1 Instructions to the patient 8 4 2 Taking the measurement 9 Problem solving 10 General information and suggestions concerning measurement 11 Astigmatism 12 Routine instrument maintenance 12 1 Check procedure with test arm set to 20 12 2 Check procedure with test arm set to 60 13 Servi...

Page 3: ...e Tonometer head is then adjusted using the dial until the inner edges of these green semicircles 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 Digital Applanation Tonometer is indicated for measuring intraocular pressure to aid in the screening and diagnosis...

Page 4: ...ntages of using a Goldmann Type Tonometer Intraocular pressure can be measured during a 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 intraocular pressure by ...

Page 5: ...rial suitable for recycling Fragile This symbol on the Product or on its Packaging and instructions indicates it was put on the market place after August 2005 and this product shall not be treated as Household Waste Keep dry Manufacturers name and address Mandatory action sign Power function button General warning sign Type B Applied Part Non ionizing radiation Battery orientation ...

Page 6: ...suring 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 the Ophthalmic Instruments Standard ISO 8612 Tonometer and ISO 15004 1 fundamental requirements and methods Classification CE Directive 93 42 EEC Class IIa FDA C...

Page 7: ...t use corrosive products or alcohol This product should not be immersed in fluid 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 fu...

Page 8: ...nt 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 the cloth is not saturated with solution Surfaces must be carefully hand dried using a clean non shedding cloth Safely dispose of used cleaning materials Continued ...

Page 9: ...vary 4 Rinse the disinfectant from the prism in running water for between 10 and 30 minutes 5 Dry the disinfected Tonometer prism with a clean soft non shedding cloth 6 Store 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 Pantasep...

Page 10: ...nometer prism under the Slit lamp and ensure there are no cracks chips the chemical used in the diagnosis process for example Fluorescein will get into the cracks and will show up if observed under the slit lamp Do not use it if there is any sign of cracks chips ...

Page 11: ...nts 1 Power function button 2 Main body 3 Rotating measurement drum 4 Doubling prism 5 Measurement arm 6 Manufacturers data 7 Test arm attachment point 8 Battery cover 9 LED display D KAT Z type Part number 2414 P 2010 9 3 6 8 7 5 4 2 1 ...

Page 12: ...on and the D KAT will return to the pressure readings display 7 3 Changing the display brightness Turn on the D KAT and press the function button for more than 3 seconds The display will flash briefly Release the function button dP decimal point or ndP no decimal point will be displayed Press the function again for more than 3 seconds the display will flash and once the function button is released...

Page 13: ...in front of the microscope for examination Rotate the Tonometer body until the prism is in the center of the view through the eyepiece Carefully tighten the two retaining grub screws in turn until the Tonometer is secure on the mount and the prism is in the center of view To obtain an image as clear and as free of reflexes as possible the angle between the illumination and the microscope should be...

Page 14: ...2 solution use a glass rod to introduce a small quantity of liquid into the conjunctival sac Seat the patient at the Slit Lamp and place his her chin on the chinrest and ensure the forehead touches the forehead rest Adjust the chinrest height so that the patients eye is at the correct height most Slit lamps have a marker on the chinrest pole for correct height adjustment Reusable prisms are not di...

Page 15: ...0 to minimise unwanted reflections Insert the blue filter on the slit lamp beam path and fully open the slit diaphragm Clean and disinfect prism as described in section 4 of this document Place the doubling prism on into the holder and align the zero mark with the white alignment line on the prism holder this ensures the mires have a horizontal split Insert the measurement arm so that the measurem...

Page 16: ...p his her eyes wide open If necessary the examiner may use the tips of his fingers to hold the lids open taking care not to exert pressure on the eye When elevating the lids the angle between the microscope and the lighting unit must be reduced to about 10 so that the light beam passes through the body of the prism In this position it should be possible to obtain an image with no reflections Immed...

Page 17: ...ythmically when the Tonometer is in the correct position for measurement Use the Slit Lamp joystick control to make any corrections needed until the applanated surface is observed as two semicircular surfaces of equal area at the Centre of the field of vision Figure 1 Small adjustments downward made with the joystick will have no effect on the sizes of the semicircular images Increase the applanat...

Page 18: ...e reading is higher than the real intraocular pressure Correction Move the slit lamp back and dry the measuring prism with a wad of sterile cotton wool or lint free cloth Cause The fluorescein semicircles are too narrow The lacrimal fluid has dried during prolonged measurement The pressure reading is lower than real ocular pressure Correction Move the Slit Lamp back and ask the patient to close hi...

Page 19: ...band to hold the patient s head in place Cause If during measurement the slit lamp is moved forward toward the patient or the patient moves toward the slit lamp the sensor arm will be pushed into contact with a stop spring and an audible alarm will sound The applanation surface will be too large The image will not change when the measurement drum is rotated Correction Retract the slit lamp until r...

Page 20: ...r pressure Correction Using the slit lamp height adjustment mechanism lower the slit lamp until the two fluorescein semi circles are equal in size The measurement pressure will then be reduced Correction Using the joystick move the slit lamp up and to the left Cause The rings are too far to the right Correction Using the joystick move the slit lamp to the right Continued ...

Page 21: ...s shown in the last illustration Correct final position The inner margins of the fluorescein semicircular images are aligned and just touching each other Cause The semicircular images are well centred The outer margins are aligned but the inner margins are not Correction Increase pressure by rotating the measurement drum Cause In this case the inner margins of one semicircle are aligned with the o...

Page 22: ...ing a preliminary measurement procedure on each eye the results of which need not be taken into consideration After completing the preliminary procedure run three measurement procedures on each eye These readings will be correct if the pressure has stabilised When the measurement procedures are performed correctly the results of the subsequent measurements will vary by only about 0 5 mmHg When the...

Page 23: ... 3 06 mm must be applanated in this case the measuring prism forms an angle of 43 to the meridian of the maximum radius Home Back Next For example For corneal astigmatism of 6 5mm 30º 52 0 diopters 30º and 8 5mm 120º 40 0 diopters 120º the 120 prism value will be aligned with the 43 A mark on the prism support For corneal astigmatism of 8 5mm 30º 40 0 diopters 30º and 6 5mm 120º 52 diopters 120º t...

Page 24: ...o 20 This is the most important check procedure since measurement of intraocular pressure in this area is highly significant We recommend running this check daily This check is made using the test arm figure 5 The arm is engraved with 5 rings The centre ring corresponds to 0 mmHg the immediate left and right rings correspond to 20 mmHg and the outer rings correspond to 60 mmHg Slide the bar along ...

Page 25: ...ntil the measurement arm moves forward Check to ensure the display reads between 19 5 and 20 5 Position 20 5 Turn the drum in the direction of the arrow until the LED display reads 20 5 Then continue to rotate the drum slowly until the measurement arm moves backwards Check to ensure the display reads between 19 5 and 20 5 Home Back Next 12 Routine Instrument Maintenance Continued ...

Page 26: ...wly until the measurement arm moves forward Check to ensure the display reads between 59 0 and 61 0 Check 61 0 limit Turn the drum in the direction of the arrow until the LED display reads 61 0 Then continue to rotate the drum slowly until the measurement arm moves backwards Check to ensure the display reads between 59 0 and 61 0 Home Back Next 12 Routine Instrument Maintenance ...

Page 27: ...in this instrument Service manuals will be available to authorised Keeler service centres and Keeler trained service personnel 13 1 Battery replacement To replace the battery press in and slide off the battery cover noting that the positive terminal of the battery is at the top The correct battery to use is 1 5v AA ALKALINE TYPE Remove the battery if the unit is to be stored for a period of 2 mont...

Page 28: ... in it s original manufacturers packaging Before use the Tonometer should be allowed to adjust to the ambient room temperature for several hours Ambient Conditions Transportation Temperature 40 C to 70 C Air Pressure 500 hPa to 1060 hPa Relative humidity 10 to 95 Storage Temperature 10 C to 55 C Air Pressure 700 hPa to 1060 hPa Relative humidity 10 to 95 Use Temperature 10 C to 35 C Air Pressure 8...

Page 29: ...e Installation Assembled on the guide plate on the slit lamp Measurement range 5 65 mmHg 0 66 8 65kPa Measurement deviation 0 49 mN or 1 5 of measurement value whichever is the greater Operating temperature range From 10 C to 35 C Reverse span Hysteresis 0 49 mN Net weight Keeler digital Z type 0 6 kg without accessories Part Numbers Keeler digital Z type 2414 P 2010 ...

Page 30: ...38 Battery Part Number 1909 P 7129 15 2 Product warranty 2 years against faulty workmanship materials and labour Warranty will be conditional on routine maintenance and will not cover calibration or mechanical issues caused as a result of lack of maintenance poor use incorrect transport or inappropriate storage conditions Tonometer doubling prism Test arm assembly Z type post R Home ...

Page 31: ...ict Beijing 10020 China Tel 86 10 51261868 Fax 86 10 58790155 Disposal of old electrical and electrical equipment Applicable in the European Union and other European Countries with separate Collection Systems This symbol on the Product or on its Packaging and instructions indicates it was put on the market place after August 2005 and this product shall not be treated as Household Waste To reduce t...

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