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Table of Contents
Summary of Contents for Keeler JAZZ SERIES
- Page 1 Jazz Instruments Jazz Instruments Instructions for use Home Back Next...
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Page 2: Table Of Contents
Contents 1. Introduction ..............p3 6.4 Replacement of LED 6.5 Spare LEDs 2. Symbols ................p4 6.6 Spare rings ..............p8 3. Safety 7. Ophthalmoscope and accessories 3.1 Device Classification 7.1 Purpose 3.2 Warnings and cautions ..........p5 7.2 Lens wheel and correcting lenses 4. Cleaning instructions 7.3 Apertures and filters ..........p9 4.1 Sterilisation ...............p6 7.4 Bulb/LED replacement 7.5 Spare Bulbs/LEDs 5. Battery handles and start-up 7.6 Spare rings ..............p10 5.1 Purpose 5.2 Start up and insertion and removal of batteries 8. Maintenance ..............p11 5.3 Turning on and off 9. Specifications and electrical ratings .......p12-18 5.4 Changing the colour coded rings ......p7 10. Warranty ...............p19 6. Otoscope and accessories 6.1 Purpose 11. Contact, packaging and disposal information ...p20 6.2 Insertion and removal of ear speculum 6.3 Introduction of external instruments into the ear ..p8... -
Page 3: Introduction
1. Introduction Thank you for purchasing your Keeler Jazz Instruments. Manufactured in compliance with Directive 93/42/EEC for medical products. Please read and follow these instructions carefully. Home Back Next... -
Page 4: Symbols
2. Symbols Read user instructions for Warnings, Cautions 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 Home Back Next... -
Page 5: Safety
Should you have any queries, please contact ambient temperature between +10ºC and +35ºC. your supplier or your Keeler Agent who will be pleased to • Keep out of the reach of children. assist you. For addresses please see the back page of these •... -
Page 6: Cleaning Instructions
4. Cleaning instructions 4.1 Sterilisation Only manual non-immersion cleaning as described should be used for this instrument. Do not autoclave or immerse in Keeler recommend that ear speculum are used once. cleaning fluids. However, the ear speculum maybe sterilised at 134° for a dwell time of 10 minutes in a steam steriliser. a Wipe the external surface with a clean absorbent, non- shedding cloth dampened with a water / detergent solution Single use - repeated use could cause infection. (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 dispose of used cleaning materials. Home Back Next... -
Page 7: Battery Handles And Start-Up
5. Battery handles and start-up 5.1 Purpose Disposal Keeler battery handles are fitted to the Keeler Jazz Please note that batteries are subject to separate disposal. Ophthalmoscope and Jazz Otoscope. For details ask your local authority and/or your environmental officer. 5.2 Start up and insertion and removal of batteries 5.3 Turning on and off Unscrew the Jazz instrument head from the handle in The handle is equipped with an an anti-clockwise direction. Insert two commercial type ‘AA’ On/Off switch. When in the up position, alkaline batteries of 1.5V (IEC standard reference LR6) into the the unit is switched on, when in the case of the handle with the two plus poles towards the upper down position, the unit is off. section of the handle. Warning: 5.4 Changing the colour coded rings • Should the unit not be used for an extended period of time... -
Page 8: Otoscope And Accessories
6. Otoscope and accessories 6.1 Purpose 6.4 Replacement of LED Keeler Jazz Otoscopes described in these instructions have been Remove instrument head from battery handle. produced for lighting and examination of the auditory canal, The LED is in the bottom section of the combined with Keeler ear speculum. -
Page 9: Ophthalmoscope And Accessories
7. Ophthalmoscope and accessories 7.1 Purpose 7.3 Apertures and filters Keeler Jazz Ophthalmoscopes described in these instructions The following apertures and/or filters may be have been designed for the examination of the eye and its selected by the aperture and filter wheel: background. Aperture Function 7.2 Lens wheel and correcting lenses 7.2 Lens wheel and correcting lenses Small Circle Designed specifically for examination of the macular region of the fundus The correcting lenses may be adjusted on where a larger beam would create the lens wheel. excessive papillary reaction or patient comfort The following correcting lenses are available: The following correcting lenses are available:... -
Page 10: Bulb/Led Replacement
7. Ophthalmoscope and accessories 7.4 Bulb/LED replacement 7.5 Spare Bulbs/LEDs Remove instrument head from battery handle. Remove instrument head from battery handle. 1011-P-5530 Jazz Ophthalmoscope Bulb The bulb/LED is located in the bottom section of The bulb/LED is located in the bottom section of 1011-P-5522 Jazz Ophthalmoscope LED (Not available in the instrument head. Remove bulb/LED from the the instrument head. Remove bulb/LED from the Europe or USA) instrument head, by using your thumb and 7.6 Spare rings forefinger. Insert new bulb/LED with the pin on forefinger. Insert new bulb/LED with the pin on the bulb/LED fitted in the recess/slot provided the bulb/LED fitted in the recess/slot provided EP39-37051 Black on the base of the instrument. EP39-37342 Pink EP39-37350 Blue Warning: • The bulb/LED may be hot Home Back Next... -
Page 11: Maintenance
8. Maintenance Jazz instruments and their accessories do not require Jazz instruments and their accessories do not require any specific maintenance. Should an instrument have any specific maintenance. Should an instrument have to be examined for any reason, please return it to 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. Home Back Next... -
Page 12: Specifications And Electrical Ratings
9. Specifications and electrical ratings Dimensions Otoscope - 18cm x 3cm x 7.5cm (H x D x W) (including handle and speculum) Ophthalmoscope - 18cm x 3cm x 3cm (H x D x W) (including handle) Weight Otoscope - 96gm (including handle without batteries) Ophthalmoscope - 87gm (including handle without batteries) Apertures Small Circle, Semi-circle, 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 +35°C 30% to 90% 800 hpa to 1060 hpa Storage: -10°C to +55°C 10% to 95% 700 hpa to 1060 hpa Transport: -40°C to +70°C... - Page 13 9. Specifications and electrical ratings Caution • PC-LED - 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. • Halogen bulb - 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. Home Back Next...
- Page 14 9. Specifications and electrical ratings Guidance and manufacturer’s declaration - The Jazz Otoscope and Ophthalmoscope have been tested (and should electromagnetic compatibility be used only with) the Jazz battery handle and lamp supplied. If the Jazz Otoscope and Ophthalmoscope are used with battery The Jazz Otoscope and Ophthalmoscope have been tested regarding handles other than the one supplied, or with lamps other than those their ability to operate in an environment containing other electrical/ recommended, this may result in increased emissions or decreased electronic equipment (including other medical devices). immunity of the Jazz Otoscope and Ophthalmoscope, in relation to EMC performance. The purpose of this testing is to ensure the Jazz Otoscope and Ophthalmoscope are not likely to adversely affect the normal It should be noted that the Jazz battery handle and lamps provided operation of other such equipment and that other such equipment with the Jazz Otoscope and Ophthalmoscope should not be used is not likely to adversely affect the normal operation of the Jazz on other equipment. To do so may result in increased emissions or Otoscope and Ophthalmoscope. decreased immunity of the other equipment in relation to EMC performance. Despite the testing of the Jazz Otoscope and Ophthalmoscope that has been undertaken, normal operation of the Jazz Otoscope The Jazz Otoscope and Ophthalmoscope should not be used adjacent and Ophthalmoscope can be affected by other electrical/electronic to or stacked with other equipment. If adjacent or stacked use with equipment and portable and mobile RF communications equipment. other equipment is necessary, the Jazz Otoscope and Ophthalmoscope and the other equipment should be observed/monitored, to verify As the Jazz Otoscope and Ophthalmoscope are classed as medical normal operation in the configuration in which it will be used.
- Page 15 9. Specifications and electrical ratings Guidance and manufacturer’s declaration – electromagnetic emissions The Jazz Otoscope / Ophthalmoscope is intended for use in the electromagnetic environment specified below. The customer or the user of the Jazz Otoscope / Ophthalmoscope should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions Group 1 The Jazz Otoscope / Ophthalmoscope uses RF energy only for its internal CISPR 11 function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions Class B The Jazz Otoscope / Ophthalmoscope is suitable for use in all CISPR 11 establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies Harmonic emissions Not Applicable buildings used for domestic purposes. IEC61000-3-2 Voltage fluctuations / Not Applicable flicker emissions IEC61000-3-3 Home Back...
- Page 16 9. Specifications and electrical ratings Guidance and manufacturer’s declaration – electromagnetic immunity The Jazz Otoscope / Ophthalmoscope is intended for use in the electromagnetic environment specified below. The customer or the user of the Jazz Otoscope / Ophthalmoscope should assure that it is used in such an environment. Immunity test IEC 60601 Test level Compliance level Electromagnetic environment - guidance Electrostatic ± 6 kV contact ± 6 kV contact Floors should be wood, concrete or ceramic tile. If floors discharge (ESD) ± 8 kV air ± 8 kV air are covered with synthetic material, the relative humidity IEC61000-4-2 should be at least 30%. Electrical fast ± 2 kV for power supply lines Not Applicable Mains power quality should be that of a typical transient / burst ± 1 kV for input / output lines commercial or hospital environment.
- Page 17 9. Specifications and electrical ratings Guidance and manufacturer’s declaration – electromagnetic immunity The Jazz Otoscope / Ophthalmoscope is intended for use in the electromagnetic environment specified below. The customer or the user of the Jazz Otoscope / Ophthalmoscope should assure that it is used in such an environment. Immunity test IEC 60601 Test level Compliance level Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the Jazz Otoscope / Ophthalmoscope, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance (d) Conducted RF 3 Vrms Not Applicable d = 1.2 √ P IEC61000-4-6 150 kHz to 80 MHz Radiated RF 3 V/m 3 V/m...
- Page 18 9. Specifications and electrical ratings Recommended separation distances between portable and mobile RF communications equipment and the Jazz Otoscope / Ophthalmoscope The Jazz Otoscope / Ophthalmoscope is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Jazz Otoscope / Ophthalmoscope can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Jazz Otoscope / Ophthalmoscope as recommended below, according to the maximum output power of the communications equipment. Rated maximum Separation distance according to frequency of transmitter output power of transmitter 150 kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz d = 1.2√ P d = 1.2√ P...
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Page 19: Warranty
10. Warranty No user serviceable parts – all preventative maintenance and servicing must only be performed by authorised 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. Bulbs/LEDs are guaranteed for 1 year from date of purchase. Home Back Next... -
Page 20: Contact, Packaging And Disposal Information
11. Contact, packaging and disposal information Manufacturer USA Sales Office Keeler Limited Keeler Instruments Inc Clewer Hill Road 3222 Phoenixville Pike Windsor Building #50 Berkshire Malvern, PA 19355 SL4 4AA Freephone: 0800 521251 Toll Free: 1 800 523 5620 Tel: +44 (0) 1753 857177...
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