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Summary of Contents for Keeler K-LED II
- Page 1 Keeler K-LED II Headlamp INSTRUCTIONS FOR USE A world without vision loss...
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Page 3: Table Of Contents
CLEANING ......................5 K-LED II HEADLAMP AND CHARGING UNITS ............5 DESCRIPTION OF THE PRODUCT ....................5 FITTING THE K-LED II HEADLAMP TO YOUR LOUPE FRAME ........6 K-LED II CHARGER POWER SUPPLY ASSEMBLY ............. 7 SET PLUG ............................7 K-LED II CHARGER AND STORAGE UNITS ............. 7 K-LED II BATTERY PACK CHARGING CYCLE ............ - Page 4 Use-by date Serial number Catalogue number Medical device Translation The Keeler K-LED II is designed and built in conformity with Directive 93/42/EEC, Regulation (EU) 2017/745 and ISO 13485 Medical Devices Quality Management Systems. Classifi cation: CE: Class I FDA: Class II The information contained within this manual must not be reproduced in whole or part without the manufacturer’s...
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Page 5: Indications For Use
The K-LED II Headlamp has been designed to be used in dental and surgical environments, to illuminate areas under examination by the user. The K-LED II is intended to be used at working distances in the range 340mm to 500mm. The K-LED II is intended to be used only by suitably trained and authorised healthcare professionals. -
Page 6: Contraindication
Note: Lithium Ion batteries contain no toxic heavy metals such as mercury, cadmium or lead. 2.2 CONTRAINDICATION There is no restriction to patient population this device can be used with other than those outlined in the contraindications stated below. The K-LED II may produce discomfort in some photophobic patients due to the high illumination. -
Page 7: Cleaning
3. Surfaces must be carefully hand-dried using a clean non- shedding cloth. 4. Safely dispose of used cleaning materials. 5. Do not operate LED until thoroughly dry. 4. K-LED II HEADLAMP AND CHARGING UNITS 4.1 DESCRIPTION OF THE PRODUCT A Power supply and adaptors... -
Page 8: Fitting The K-Led Ii Headlamp To Your Loupe Frame
KEELER K-LED II 5. FITTING THE K-LED II HEADLAMP TO YOUR LOUPE FRAME 1. To remove the loupes from the frame, 2. Attach the LED light to the loupe bar. hold the loupe bar between your thumb Ensure that the LED light is fitted and forefinger of one hand and pull away correctly and held securely in position. -
Page 9: K-Led Ii Charger Power Supply Assembly
KEELER K-LED II 6. K-LED II CHARGER POWER SUPPLY ASSEMBLY 6.1 SET PLUG Replace the blanking plate with the appropriate mains plug adaptor if required, or use IEC 60320 TYPE 7 connector (not supplied). 7. K-LED II CHARGER AND STORAGE UNITS 1. -
Page 10: Charging Cycle
Charging well 2 9. SPECIFICATIONS AND ELECTRICAL RATINGS The Keeler KLED II and chargers is a medical electrical instrument. The instrument requires special care concerning electromagnetic compatibility (EMC). This Section describes its suitability in terms of electromagnetic compatibility of this instrument. When installing or using this instrument, please read carefully and observe what is described here. -
Page 11: Electromagnetic Immunity
9.2 ELECTROMAGNETIC IMMUNITY Guidance and manufacturer’s declaration – electromagnetic immunity The Keeler Spectra Iris/K-LED is intended for use in the electromagnetic environment specified below. The customer or user should ensure that it is used in such an environment. Immunity test... - Page 12 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Keeler Spectra Iris/K-LED is used exceeds the applicable RF compliance level above, the Keeler Spectra Iris/K-LED should be observed to verify normal operation.
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Page 13: Recommended Safe Distances
Keeler Spectra Iris/K-LED The Keeler Spectra Iris/K-LED are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Keeler Spectra Iris/K-LED can help prevent electromagnetic interference by maintaining a minimum distance... -
Page 14: Spare Parts And Accessories
KEELER K-LED II Environmental Conditions: 1060 hPa °C °C 800 hPa Shock (without packing) 10 g, duration 6 ms STORAGE CONDITIONS 1060 hPa °C °C 700 hPa TRANSPORT CONDITIONS 1060 hPa °C °C 500 hPa Vibration, sinusoidal 10 Hz to 500 Hz: 0.5g... -
Page 15: 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: •... - Page 16 Contact Manufacturer Keeler Limited Clewer Hill Road Windsor Berkshire SL4 4AA UK Freephone 0800 521251 Tel +44 (0) 1753 857177 Fax +44 (0) 1753 827145 USA Sales Office China Office Keeler USA Halma China Group 3222 Phoenixville Pike 名称：沃迈（上海）机电有限公司 Building #50 地址：上海市闵行区金都路1165弄...
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