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6. Safety

The Keeler Portable Slit Lamp is designed and built in conformity

with EC Directive 93/42/EEC and the ISO 9000 and EN 46000 series

quality standards.

The

(European Community) mark attests that the Slit Lamp

complies with the provisions of Annexes I, VI, and VII of EC

Directive 93/42/EEC.

Classification: CE Regulation 93/42 EEC: Class I

FDA: Class II

Production processes, testing, start-up, maintenance, and repairs

are conducted in strict conformity with the applicable laws and

international reference standards.

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Содержание PSL Classic

Страница 1: ...Instructions for use Home Back Next ...

Страница 2: ...le Slit Lamp prior to use Preparing the patient 12 Problem solving 13 Changing the bulb 14 Routine instrument maintenance 15 Specifications and electrical ratings 16 Technical specifications 17 Accessories 18 Contact packaging and disposal information Please click on the contents to go straight to your chosen section or navigate by using the Next and Back buttons to the right Clicking on Home will...

Страница 3: ...magnification optics Base charger unit Power supply switch mode all voltages frequencies Part 1941 P 7778 User instructions and quick guide Lens cloth The information contained within this manual must not be reproduc in whole or part without the manufacturer s prior written approval The manufacturer reserves the right to make changes to specifications and other information contained in this docume...

Страница 4: ... B protections against shock This way up Consult instructions for use Material suitable for recycling Manufacturers name and address This Symbol on the Product or on its Packaging and instructions indicates that it was put on the market place after August 2005 and that this product shall not be treated as Household Waste Home Back Next 4 ...

Страница 5: ...nation of the anterior eye segment from the cornea epithelium to the posterior capsule It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment This device is intended to be used only by suitably trained and authorised healthcare professionals Home Back Next 5 ...

Страница 6: ...oscope The lamp facilitates an examination of the anterior segment or frontal structures and posterior segment of the human eye which includes the eyelid sclera conjunctiva iris natural crystalline lens and cornea The binocular Slit Lamp examination provides stereoscopic magnified view of the eye structures in detail enabling anatomical diagnoses to be made for a variety of eye conditions Home Bac...

Страница 7: ...e battery powering the illumination system The illumination system and fixation targets are activated using a double click trigger located on the front of the grip handle To increase or reduce the light intensity there is a rheostat located below the eyepieces on the rear of the grip handle PSL Classic The 10x and 16x magnification optical system is controlled using a flip lever located under the ...

Страница 8: ...uropean Community mark attests that the Slit Lamp complies with the provisions of Annexes I VI and VII of EC Directive 93 42 EEC Classification CE Regulation 93 42 EEC Class I FDA Class II Production processes testing start up maintenance and repairs are conducted in strict conformity with the applicable laws and international reference standards Home Back Next 8 ...

Страница 9: ... and persons with diseased eyes may be at a higher risk The risk may also be slightly increased if the person being examined has had any exposure with the same instrument or an other ophthalmic instrument using an intense visible light source during the previous 24 hours This will apply particularly if the eye has been subjected to retinal photography Caution The light emitted from this instrument...

Страница 10: ...al hazard is a product of the radiance and the exposure time If the value of radiance were reduced in half twice the time would be needed to reach the maximum exposure limit While no acute optical radiation hazards have been identified for slit lamps it is recommended that the intensity of light directed into the patient s eye be limited to the minimum level which is necessary for diagnosis Infant...

Страница 11: ...rnal 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 Avoid optical surfaces b Ensure that excess solution does not enter the instrument Use caution to ensure cloth is not saturated with solution c Surfaces must be carefully hand dried using a clean non shedding cloth d Safely dispo...

Страница 12: ...turers packaging Before use the Slit Lamp should be allowed to adjust to the ambient room temperature for several hours This is especially important when the unit has be stored or transported in a cold environment this can cause severe condensation on the optical elements Working environment 10 C to 35 C 30 to 75 relative humidity Transport and storage conditions Transport 40 C to 70 C Storage 10 ...

Страница 13: ...d repairs furthermore any such actions will invalidate the warranty Should the instrument suffer shocks for example should it accidentally fall and the optical system or the illumination system are damaged it may be necessary to return the instrument to the manufacturer for repair Always carefully observe the safety rules and other precautions published herein This device is intended to be used on...

Страница 14: ... value 5 Latex free protective sleeves These sleeves can be folded forwards to better suit spectacle wearers 6 Fixation targets Provides a light source for the patient to focus upon Double click similarly to a computer mouse button to turn both the illumination lamp and fixation targets on 7 Objective lenses These lenses are flush with the external surface at a magnification of 10x and protrude fr...

Страница 15: ...his wheel clockwise increases the brightness of the illumination lamp Rotating this wheel anti clockwise decreases the brightness of the illumination lamp Portable Slit Lamp base charger unit 17 15 Power socket for Keeler 12V Power Supply Connect the power supply cable to this socket and the place the slit lamp body in the charger unit to charge the device 16 Recharging connection pins Connects th...

Страница 16: ... supplied 2 Connect the output power supply cable to the socket on the underside of the recharging base unit 3 Place the Portable Slit Lamp on the base charger unit the yellow LED will illuminate to indicate the unit is being charged From fully discharged to fully charged usually takes 2 5 hours Illumination on time 50 minutes when used at full intensity from fully charged IEC 60320 TYPE 7 connect...

Страница 17: ...ces one at a time Adjust the eyepiece to it s highest plus setting and looking through the optics at the peripheral focus marker slowly adjust the eyepiece towards the minus setting until the focus marker is sharply in focus Repeat this for the other eyepiece Peripheral focus marker it automatically switches off Note for very small or young patients babies in arms and some animals sometimes it may...

Страница 18: ...p is designed to be ambidextrous hold the Slit Lamp in your preferred hand simultaneously squeezing the trigger on off switch To improve stability especially at higher magnifications you may like to use your other hand as a bridge between the Slit Lamp body and the patient As with other Slit Lamp examination procedures it may be necessary to elevate the patient s lid Home Back Next 18 ...

Страница 19: ...ly illumination Check and if necessary change the bulb Slit slanted at an Check the position of the slit disc it may not be located correctly at a slit angle position Circle incomplete Check the position of the slit and filter discs it may not be located or offset correctly at a slit position Poor focus Check the dioptric settings of the eyepieces Home Back Next 19 ...

Страница 20: ...the bulb 1 To change the bulb first allow 5 minutes for it to cool down if the Slit Lamp has been in use This is how you change a bulb 1 Unscrew the black plastic bulb cover by turning anti clockwise 2 Remove the old bulb allow 5 minutes for it to cool down if the Slit Lamp has been in use 2 3 3 Insert the new bulb ensuring the notch is facing upwards as shown Home Back Next 20 ...

Страница 21: ...e should the instrument be tampered with in any manner or should routine maintenance be omitted or performed in manners not in accordance with these manufacturer s instructions Caution Keeler Slit Lamps should be cleaned and serviced regularly Any servicing or repairs should only be carried out by Keeler Ltd or by suitably trained and authorised distributors There are no user serviceable parts in ...

Страница 22: ...ne s to line s Mains power quality should be that of a typical IEC 61000 4 5 1 kV line s for input 1 kV line s for input commercial or hospital environment output line s output line s Voltage dips short 5 UT 95 dip in UT 5 UT 95 dip in UT Mains power quality should be that of a interruptions and 40 UT 40 UT typical commercial or hospital environment voltage variations on If the user of the Keeler ...

Страница 23: ...Slit Lamp is intended for use in the electromagnetic environment specified below The customer or user should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The Keeler Portable Slit Lamp uses RF energy only for its CISPR 11 internal function Therefore its RF emissions are very low and are not likely to cause any inte...

Страница 24: ...s determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Note 1 At 80MHz and 800MHz the higher frequency range applies Note 2 These guide lines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures...

Страница 25: ...Rated maximum Separation distance according to frequency of transmitter output power of m transmitter 50 kHz to 80MHz 80MHz to 800MHz 800MHz to 2 5GHz W d 1 2 p d 1 2 p d 2 3 p 0 01 0 12 0 12 0 23 0 01 0 37 0 37 0 74 1 1 2 1 2 2 3 10 3 7 3 7 7 4 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be determined using t...

Страница 26: ...ctive lens working distance 10x 100mm PSL One PSL Classic Objective lens working distance 16x 80mm PSL Classic Field of view 10x 16mm PSL One PSL Classic Field of view 16x 10 5mm PSL Classic PD range 50mm to 72mm Eyepiece dioptric adjustment range 7 Dioptres Size Hand held device 238 x 116 x 210 mm Docking station 205 x 138 x 40 mm Weight Hand held device 900g Docking station 300g Home Back Next 2...

Страница 27: ... Illumination control Continuously variable from low to full brightness Power supply Power supply unit Switch mode 110V 240V 10 multi plug compliant to EN60601 1 EN 61000 6 2 EN 61000 6 3 Power supply output 30VA 12V DC 2 5A Complies with Electrical Safety Medical BS EN 60601 1 2006 Electromagnetic compatibility EN 60601 1 2 2007 Ophthalmic instruments Fundamental requirements and test methods ISO...

Страница 28: ...art Number 3010 P 7000 Test Bar Part Number EP39 70737 Power Supply Part Number 1941 P 7778 2x Rubber Eye Caps Part Number 3010 P 7004 iPhone 4 Adapter Part Number 3010 P 7010 Consumables Slit Lamp 6V 15W Bulb Part Number 1030 P 7187 Home Back Next 28 ...

Страница 29: ...ountries with separate Collection Systems This Symbol on the Product or on its Packaging and instructions indicates that it was put on the market place after August 2005 and that this product shall not be treated as Household Waste To Reduce the Environmental impact of WEEE Waste Electrical Electronic Equipment and minimise the volume of WEEE entering landfills we encourage at Product end of life ...

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