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Summary of Contents for Keeler K-LED II
- Page 1 Keeler K-LED II Headlamp Instructions for use Instructions for use Next Next...
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Page 2: Table Of Contents
Contents Page 1. Copyright and trademarks ........... 3 2. Introduction ................4 • Product description 3. Symbols .................. 5 4. Safety ..................6 • Device classification • Warnings • Cautions ................7 5. K-LED II Headlamp and charging units ........ 8 • Product description 6. Fitting K-LED II headlamp to your loupe frame ....9 7. K-LED II charging and storage units ........ -
Page 3: Copyright And Trademarks
1. Copyright and trademarks The information contained within this manual must not be reproduced in whole or in part without the manufacturer’s prior written approval. As part of our policy for continued product development we reserve the right to make changes to specifications and other information contained in this document without prior notice. K-LED II is a registered trademark of Keeler Ltd 2012. Copyright © Keeler Limited 2012. Published in the UK 2012. Home Back Next... -
Page 4: Introduction
2. Introduction Thank you for purchasing the Keeler K-LED II Headlamp We have taken the greatest care in the design, development and manufacture of this product to ensure that you get many years of trouble free service. However, it is important that you read the descriptions, installation and operating instructions carefully prior to installing or using your new indirect ophthalmoscope. The K-LED II Headlamp has been designed to be used in dental and surgical environments, to illuminate areas under examination by the user. Please read and follow these instructions carefully. Home Back Next... -
Page 5: Symbols
3. Symbols Read user instructions for warnings, cautions and Follow instructions for use additional information High voltage The CE mark on this product indicates it has been tested to and conforms with the provisions noted Trip hazard within the 93/42/EEC Medical Device Directive Optical radiation hazard Double insulated Hot surface Manufacturer's name and address This way up This Symbol on the product or on its packaging and instructions indicates that it was put on the Keep dry Keep dry market place after August 2005 and that this product shall not be treated as Household Waste Fragile Type B protections against shock Material suitable for recycling Material suitable for recycling Mandatory action sign Home Back Next... -
Page 6: Safety
• Do not dispose of battery in fire, puncture or short circuit Carefully read this Instruction Section before using your Keeler • Do not use a battery that is deformed, leaking, corroded or product. For your own safety and that of your customers visually damaged. Handle a damaged or leaking battery with observe all cautionary information provided in this section. The care. If you come into contact with electrolyte, wash exposed following information is intended to highlight potential safety area with soap and water. If it contacts the eye, seek medical hazards that can be associated with misuse, or damage. attention immediately Warnings and cautions • US Federal law restricts this device to sale by or order of a physician or practitioner Warning Do not fit mains power adapter into a damaged mains • Check your Keeler product for signs of transport / storage outlet socket damage prior to use Route power cords safely to eliminate risk of tripping or • Do not use if the product is visibly damaged, and periodically damage to equipment inspect for signs of damage LED’s can reach high temperatures in use – allow to cool • Do not shine directly into a person’s eye. Do not stare into the before handling light when in use. May be harmful to eyes After removal of the LED do not • Do not hold magnifying glasses or any other optical system in touch the LED contacts and the front of the light patient simultaneously • Do not use in the presence of flammable gases / liquids, or in... -
Page 7: Cautions
4. Safety Caution • Do not charge battery in any environment where the • Use only genuine Keeler approved parts and accessories or temperature may exceed 40˚C or fall below 0˚C. There are no device safety and performance may be compromised user serviceable parts inside. Contact authorised service representative for further information • Use only Keeler approved batteries, chargers and power supplies as per the accessories listed in section 11 • Ensure device is securely held in docking station to minimise risk of injury or damage to equipment • Ensure the equipment is positioned in such a way that it can be disconnected from the mains easily • Follow guidance on cleaning / routine maintenance to prevent personal injury / damage to equipment • The product has been designed to function safely when at an ambient temperature between +10°C and +35°C Switch off the electrical supply and disconnect from the mains electrical supply before cleaning and inspection • Keep out of the reach of children • Dispose of batteries in line with local environmental • To prevent condensation from forming, allow instrument to regulations come to room temperature before use • At product end of life dispose of in accordance with local • For indoor use only (protect from moisture) environmental guidelines (WEEE) • When replacing lithium battery pack, turn K-LED II off and... -
Page 8: K-Led Ii Headlamp And Charging Units
5. K-LED II Headlamp and charging units Description of the Product A Power supply and adaptors B Rechargeable battery pack C Single charger storage unit D Double charger storage unit E LED light source F Connector Home Back Next... -
Page 9: Fitting K-Led Ii Headlamp To Your Loupe Frame
6. Fitting the K-LED II Headlamp to your loupe frame 1 To remove the loupes from the 2 Attach the LED light to the loupe bar. 3 Re-attach the loupes and LED light to frame, hold the loupe bar between Ensure that the LED light is fitted the frame hinge by holding the loupe your thumb and forefinger of one correctly and held securely in position, bar as before. hand and pull away from the hinge as shown. held in your other hand Locate the hinge pins into the loupe bar holes and push the loupes onto the hinge. Home Back Next... - Page 10 6. Fitting the K-LED II Headlamp to your loupe frame 4 If the LED light is to be used on its own without loupes, 5 Connect the LED light lead into the attach the Light to the Adaptor PD bar as shown. Attach the connector port on top of the battery pack. cable to the frame using the Velcro strap provided. Home Back Next...
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Page 11: Power Supply Assembly
7. K-LED II charger power supply assembly Set Plug Replace the blanking plate with the appropriate mains plug adaptor if required, or use IEC 60320 TYPE 7 connector (not supplied). IEC 60320 TYPE 7 connector Home Back Next... -
Page 12: K-Led Ii Charging And Storage Units
7. K-LED II charger and storage units Power up the charger and storage unit by plugging it in to a mains outlet. The green LED shows the unit is powered. Turn the battery pack off, and place into the charging well as shown. A yellow LED indicates the battery pack’s charge state. Single charger storage unit Double charger storage unit Home Back Next... - Page 13 7. K-LED II battery pack charging cycle Charging cycle The battery pack can be used at any time during the charging cycle and will automatically resume charging when replaced in Single charger storage unit the charging well. The battery will take approximately 2 hours to fully The battery pack can be left in the charger storage unit when it charge. is not being used. The charger will automatically stop charging Double charger storage unit the battery pack when fully charged. The battery will take approximately 2 hours to fully Charging the battery pack charge in charging well 1 and approximately 4 hours to fully charge in charging well 2. Green LED Charging storage unit powered No yellow LED Battery charged Flashing yellow LED Top-up charge Solid yellow LED Rapid charge...
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Page 14: Cleaning Instructions
8. Cleaning • Only manual non-immersion cleaning as described should be used for this instrument • Do not autoclave or immerse in cleaning fluids Always disconnect power supply from source before cleaning a 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). 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 e Do not operate LED until thoroughly dry Home Back Next... -
Page 15: Specifications And Electrical Ratings
9. Specifications and electrical ratings Input mains data: 100-240V – 50/60Hz 700mA Power supply rating: 12V : 2.5amps Operation: Continuous Classification: Class II equipment Type B protection against shock Transport, storage and operating conditions Transport Storage Operation Temperature -40°C -10°C +10°C range to +70°C to +55°C to +35°C Relative 10% to 95% 10% to 95% 30% to 75% humidity Home Back Next... -
Page 16: Annex I - Emc Statement And Guidelines
10. Annex I – EMC statement and guidelines The Keeler K-LED II and chargers are medical electrical instruments. These instruments require special care concerning electromagnetic compatibility (EMC). This section describes the suitability in terms of electromagnetic compatibility of these instruments. When installing or using these instruments, please read carefully and observe what is described here. Portable or mobile-type radio frequency communication units may have an adverse effect on these instruments, resulting in malfunctioning. Home Back Next... - Page 17 10. Annex I – EMC statement and guidelines Guidance and manufacturer’s declaration – electromagnetic immunity The Keeler K-LED II and chargers are intended for use in the electromagnetic environment specified below. The customer or the user should assure that they are 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. discharge (ESD). ± 8 kV air ± 8 kV air If floors are covered with synthetic material, the relative IEC 61000-4-2 humidity should be at least 30%. Electrical fast ± 2 kV for power supply lines ± 2 kV for power supply lines Mains power quality should be that of a typical commercial transient/burst. ± 1 kV for input/output lines or hospital environment. IEC 61000-4-4 Surge. ± 1 kV line(s) to line(s) ± 1 kV line(s) to line(s) Mains power quality should be that of a typical commercial IEC 61000-4-5 ± 2 kV line(s) to earth or hospital environment.
- Page 18 10. Annex I – EMC statement and guidelines Guidance and manufacturer’s declaration – electromagnetic emissions The Keeler K-LED II and chargers are intended for use in the electromagnetic environment specified below. The customer or user should assure that they are used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions Group 1 The Keeler K-LED II chargers use RF energy only for their internal function. CISPR 11 Therefore, the RF emissions are very low and are not likely to cause any Single / double interference in nearby electronic equipment. charger only RF emissions Class B The Keeler K-LED II chargers use RF energy only for their internal function. CISPR 11 Therefore, the RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. Harmonic emissions Class A IEC 61000-3-2 Voltage fluctuations / Complies flicker emissions IEC 61000-3-3 The Keeler K-LED II is considered to be inherently EMC benign¹, and therefore is not covered by the statements in this section. ¹ Refer to section 1.1.4 of the Guide for the EMC Directive 2004/108/EC (published 21st May 2007). Home Back...
- Page 19 Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the Keeler K-LED II or chargers, including cables, than the recommended separation distances calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF 3 Vrms d = 1.2 √ p IEC 61000-4-6 150 kHz to 80 MHz d = 1.2 √ p 80MHz to 800 MHz Radiated RF 3 V/m 3 V/m d = 2.3 √ p 800MHz to 2.5GHz IEC 61000-4-3 80MHz to 2.5GHz Where p is the maximum output power rating of the transmitter in watts(W) according to the transmitter manufacturer and d is the recommended separation distance in metres(m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey¹, should be less than the compliance level in each frequency range.² 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, objects and people. ¹ Field strengths from fixed transmitters, such as base stations ( cellular / cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. 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 K-LED II / charger is used exceeds the applicable RF compliance level above, the Keeler K-LED II / charger should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orientating or relocating the Keeler K-LED II / charger. Home Back Next ² Over the frequency range 150kHz to 80 MHz, field strengths should be less than 3 V/m.
- Page 20 10. Annex I – EMC statement and guidelines Recommended separation distances between portable and mobile RF communications equipment and the Keeler K-LED II / charger The Keeler K-LED II and charger are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Keeler K-LED II / charger can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Keeler K-LED II / charger 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 d = 2.3√ p 0.01 0.12 0.12 0.23 0.37 0.37 0.74 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. 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, objects and people. Home Back...
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Page 21: Spare Parts And Accessories
11. Spare parts and accessories The following spares and accessories are available from the distributor: Part Number Description EP29-32777 Power supply EP39-57298 Yellow filter cap 1919-P-5215 Battery pack 1941-P-5350 Twin charger 1941-P-5385 Single charger 2001-P-7027 Adaptor PD Bar Home Back Next... -
Page 22: Warranty
12. 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 instrument and accessories have been used in compliance with these instructions • Proof of purchase accompanies any claim Please note: Batteries are covered by this warranty statement for 1 year only. Home Back Next... -
Page 23: Contact And Disposal Information
13. Contact and disposal information Keeler Limited Keeler Instruments Inc Clewer Hill Road 3222 Phoenixville Pike Windsor Building #50 Berkshire SL4 4AA Malvern, PA 19355 England Freephone: 0800 521 251 Toll Free: 1 800 523 5620 Tel: +44 (0)1753 857177...
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