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3. Safety

3.1 Device Classification

CE Regulation 93/42 EEC: Class 1

3.2 Warnings and cautions

            Warning 

• Please read these instructions carefully prior to use and keep  
  in a safe place. 
Should you have any queries, please contact   
  your supplier or your Keeler Agent who will be pleased to    
  assist you. For addresses please see the back page of these    
  instructions. The address of your authorised Keeler Agent can  
  be supplied on request.

• Please note that any instruments described in these    
  instructions are only suited for application by trained   

 

 operators.

• Correct and safe operation of instruments will only be  

 

  guaranteed when Keeler instruments and accessories are used  
 throughout.

• Do not use if the product is visibly damaged and periodically  
  inspect for signs of damage.

• Do not use in the presence of flammable gases or an oxygen  
  rich environment

• This product should not be immersed in fluids.

• Batteries must be inserted as per instructions - see section 5.2

• No modification to this equipment is allowed.

• Do not touch battery terminals and patient simultaneously.

• Instrument may become hot if used for extended periods
  of time.

             Caution

• The product has been designed to function safely when at an  
  ambient temperature b10ºC and +35ºC.

• Keep out of the reach of children.

• To prevent condensation from forming, allow instrument to   
  come to room temperature before use.

• LEDs become hot during use, caution should be taken  

 

  when replacing LEDs.

• The light emitted from this instrument is potentially    
  hazardous. The longer the duration of exposure, the   

 

  greater the risk of ocular damage. Exposure to light from this  
  instrument when operated at maximum
  intensity will exceed the safety
  guideline after 30 minutes.

Содержание Jazz Ultra SERIES

Страница 1: ...Next Jazz Ultra Instruments Instructions for use ...

Страница 2: ... Replacement of LED 6 5 Spare LEDs 6 6 Spare rings p8 7 Ophthalmoscope and accessories 7 1 Purpose 7 2 Lens wheel and correcting lenses 7 3 Apertures and filters p9 7 4 LED replacement 7 5 Spare LEDs 7 6 Spare rings p10 8 Maintenance p11 9 Specifications and electrical ratings p12 17 10 Warranty p18 11 Contact packaging and disposal information p19 Please click on the contents to go straight to yo...

Страница 3: ...me Back 3 1 Introduction Thank you for purchasing your Keeler Jazz Ultra Instruments Manufactured in compliance with Directive 93 42 EEC for medical products Please read and follow these instructions carefully ...

Страница 4: ...and 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 Type B protections against shock ...

Страница 5: ...inspect for signs of damage Do not use in the presence of flammable gases or an oxygen rich environment This product should not be immersed in fluids Batteries must be inserted as per instructions see section 5 2 No modification to this equipment is allowed Do not touch battery terminals and patient simultaneously Instrument may become hot if used for extended periods of time Caution The product h...

Страница 6: ...sopropyl 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 dispose of used cleaning materials 4 1 Sterilisation Keeler recommend that ear speculum are used once However the ear speculum maybe ...

Страница 7: ...educed thus affecting examination For maximum light yield it is recommended to always insert new high quality batteries on replacement Never immerse handles in fluid Ensure that no fluid or condensation penetrates into the handle Disposal Please note that batteries are subject to separate disposal For details ask your local authority and or your environmental officer 5 3 Turning on and off The han...

Страница 8: ...3 Introduction of external instruments into the ear When intending to introduce external instruments into the ear such as forceps turn magnifying lens approx 2 5X enlargement on otoscope head in anti clockwise direction Replace cover lens in reverse direction 6 4 Replacement of LED Remove instrument head from battery handle The LED is in the bottom section of the instrument head Remove LED by usin...

Страница 9: ...following apertures and or filters may be selected by the aperture and filter wheel 7 Ophthalmoscope and accessories Aperture Function Small Circle Designed specifically for examination of the macular region of the fundus where a larger beam would create excessive papillary reaction or patient comfort Semi circle For reduction of reflexes of small pupils Large Circle For standard fundus examinatio...

Страница 10: ...e LED from the instrument head by using your thumb and forefinger Insert new LED with the pin on the LED fitted in the recess slot provided on the base of the instrument Warning The LED may be hot 7 5 Spare LEDs 1011 P 7122 Jazz Ultra Ophthalmoscope LED 7 6 Spare rings EP39 37051 Black EP39 37342 Pink EP39 37350 Blue 7 Ophthalmoscope and accessories ...

Страница 11: ...ts and their accessories do not require any specific maintenance Should an instrument have to be examined for any reason please return it to your supplier or an authorised dealer in your area Addresses can be supplied on request or visit www keeler co uk ...

Страница 12: ...le Large Circle Fixation Star Red free filter Cobalt Blue filter see page 9 Diopters 0 to 20 and 0 to 20 see page 9 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 15004 1 2006 Optical radiation hazard ISO 15004 2 2007 Environment Temperature Humidity Pressure Use 10 C to...

Страница 13: ...nto service in accordance with the instructions guidance provided herein and are used only in the configuration as supplied The Jazz Ultra Otoscope and Ophthalmoscope have been tested and should be used only with the Jazz Ultra battery handle and lamp supplied If the Jazz Ultra Otoscope and Ophthalmoscope are used with battery handles other than the one supplied or with lamps other than those reco...

Страница 14: ... RF emissions CISPR 11 Group 1 The Jazz Ultra Otoscope Ophthalmoscope uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The Jazz Ultra Otoscope Ophthalmoscope is suitable for use in all establishments including domestic establishments and those directly conn...

Страница 15: ...y should be that of a typical commercial or hospital environment Surge IEC61000 4 5 1 kV line s to line s 2 kV line s to earth Not Applicable Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip ...

Страница 16: ...elds strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affec...

Страница 17: ...the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80MHz d 1 2 P 80MHz to 800MHz d 1 2 P 800MHz to 2 5GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 3 For transmitters rated at a maximum output power not listed above the recommended separation distance d in met...

Страница 18: ...d Keeler representatives Your Keeler product is guaranteed for 3 years and will be replaced or repaired free of charge subject to the following Any fault due to faulty manufacture The device has been used in compliance with these instructions Proof of purchase accompanies any claim LEDs are guaranteed for 1 year from date of purchase ...

Страница 19: ...the Environmental impact of WEEE Waste Electrical Electronic Equipment and minimise the volume of WEEE entering landfills we encourage at Product end of life that this Equipment is recycled and reused If you need more information on the collection reuse and recycling then please contact B2B Compliance on 01691 676124 44 1691 676124 Manufacturer Keeler Limited Clewer Hill Road Windsor Berkshire SL4...

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