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13. Specifications

13.1 Transport, storage and working conditions

The following ambient condition limits are recommended for
the Keeler Applanation Tonometer, for transport and storage
it is recommended that the Tonometer is kept 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

Air Pressure

500 hPa to 1060 hPa

Relative humidity

10% to 95%

Storage

Temperature

-10

C to +55

Air Pressure

700 hPa to 1060 hPa

Relative humidity

10% to 95%

Storage

Temperature

+10

C to +35

Air Pressure

800 hPa to 1060 hPa

Relative humidity

30% to 75%

Summary of Contents for KAT

Page 1: ...Home Back Instructions for use Next Keeler Applanation Tonometer KAT ...

Page 2: ...0 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 calibra...

Page 3: ... 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 Applana...

Page 4: ...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 abou...

Page 5: ... 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 ...

Page 6: ...2 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 Regulat...

Page 7: ...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 resp...

Page 8: ...rument 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 ...

Page 9: ...d 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 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 Pantasept 3 aqueous...

Page 10: ...eck 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 ...

Page 11: ...omponents of R type and T type KAT 1 Control weight housing 2 Rotating measurement knob 3 Doubling prism 4 Measurement arm 5 Manufacturers data 6 T type mounting assembly 7 R type mounting assembly 8 Calibration arm assembly T type KAT take away Part number 2414 P 2030 3 8 4 5 6 2 1 ...

Page 12: ...on the horizontal guide plate above the slit lamp axis These positions are related to the microscope optics and observation can be made either through the right or the left eye piece The Tonometer will slip easily onto the support plate stability is assured by the locking pins To obtain an image as clear and as free of reflexes as possible the angle between the illumination and the microscope shou...

Page 13: ...the mounting post Swing the Tonometer forward in front of the microscope for examination A notch position ensures exact centring of the prism with the left objective To obtain an image as clear and as free of reflexes as possible the angle between the illumination and the microscope should be about 60 and the slit diaphragm should be fully opened When not in use the instrument is swung around and ...

Page 14: ... be removed When using drops we recommend a 0 5 solution of fluorescein sodium If using a 1 or 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 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 ...

Page 15: ...phragm Clean the doubling prism with Pantasept fluid at between 0 5 and 3 0 concentration or with a similar disinfectant solution that is innocuous to organic glass plexiglass After cleaning rinse the doubling prisms in distilled water and allow to dry Full instructions on cleaning the prism is covered earlier in this manual Place the doubling prism on into the holder and align the zero mark with ...

Page 16: ...o keep 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 ...

Page 17: ...e 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 applanation pressure by rotating the Tonometer mea...

Page 18: ...ssure 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 semi circles 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 clo...

Page 19: ...If possible use a 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 The applanation surface will be too large The image will not change when the measurement drum is rotated Correction Retract the slit lamp until regular pulses ...

Page 20: ... ocular pressure Correction Using the slit lamp height adjustment mechanism lower the slit lamp until the two fluorescein semi circles are equal in size 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 ...

Page 21: ... 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 semi circular 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: ...running 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...

Page 23: ...2 ø 3 06 mm must be applanated in this case the measuring prism forms an angle of 43 to the meridian of maximum radius Home Back Next For example For corneal astigmatism of 6 5mm 30º 52 0 dioptres 30º and 8 5mm 120º 40 0 diopter 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 dioptres 30º and 6 5mm 120º 52 dioptres 120º the...

Page 24: ...libration Position 0 05 Rotate the measurement drum zero calibration downward by the width of one calibration mark see Figure 3 When the sensor arm is in the free movement zone it should move against the stop in the examiner s direction Calibration Position 0 05 Rotate the measurement drum zero calibration upward by the width of one calibration mark see figure 4 When the sensor arm is in the free ...

Page 25: ...to drum position 0 the two immediately to the left and right to position 2 and the outermost two to position 6 The arm is only marked on both sides of 0 to maintain symmetry in order to calibrate Slide the bar in the support until one of the position 2 marks on the weight is located exactly at the reference mark of the weight support figure 5 With the weight of the bar towards the examiner the 2 c...

Page 26: ... by the width of one calibration mark see Figure 6 When the sensor arm is in the free movement zone it should move against the stop in the examiner s direction Calibration Position 2 05 Rotate the measurement drum 2 calibration upward by the width of one calibration mark see figure 7 When the sensor arm is in the free movement zone it should move against the stop in the patient s direction Home Ba...

Page 27: ...ure with a scale 6 calibration is very similar to those described above The checkpoints are 5 9 and or 6 1 Rotate the 6 calibration mark on the drum through interval downward and or upward respectively with respect to the index mark Home Back Next 6 6 11 Routine Instrument Maintenance ...

Page 28: ...nnual calibration of the instrument This must be performed by an authorised service centre or distributor There are no user serviceable parts in this instrument Service manuals will be available to authorised Keeler service centres and Keeler trained service personnel ...

Page 29: ...n 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 Storage Temperature 10 C to 35 C Air Pressure...

Page 30: ...84 mN measurement range Operating temperature range Measurement uncertainty Net weight Keeler T type Keeler R type Part Numbers Keeler T type Keeler R type By leverage weight Fitted to the guide plate on the optical axis for the microscope and illumination unit arm Mountable on post on microscope Assembled on the guide plate on the slit lamp arm 0 80 mmHg 0 10 64 kPa Standard divergence 0 49 mN _ ...

Page 31: ...xury carrying case Part Number 3414 P 7000 14 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 Calibration arm assembly T type guide plate...

Page 32: ... Road Windsor Berkshire SL4 4AA UK Freephone 0800 521251 Tel 44 0 1753 857177 Fax 44 0 1753 827145 USA Sales Office Keeler Instruments Inc 3222 Phoenixville Pike Building 50 Malvern PA 19355 USA Toll Free 1 800 523 5620 Tel 1 610 353 4350 Fax 1 610 353 7814 EP59 70020 Issue D 0088 ...

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