Keeler K-LED II Manual de usuario
Keeler K-LED II
Headlamp
INSTRUCTIONS FOR USE
A world without vision loss
1 EN
KEELER K-LED II
CONTENTS
1. INDICATIONS FOR USE ........................................................................................ 3
2. SAFETY................................................................................................................. 3
2.1 WARNINGS AND CAUTIONS..........................................................................................................3
2.2 CONTRAINDICATION.....................................................................................................................4
3. CLEANING ............................................................................................................ 5
4. K-LED II HEADLAMP AND CHARGING UNITS........................................................ 5
4.1 DESCRIPTION OF THE PRODUCT....................................................................................................5
5. FITTING THE K-LED II HEADLAMP TO YOUR LOUPE FRAME .................................. 6
6. K-LED II CHARGER POWER SUPPLY ASSEMBLY..................................................... 7
6.1 SET PLUG......................................................................................................................................7
7. K-LED II CHARGER AND STORAGE UNITS............................................................. 7
8. K-LED II BATTERY PACK CHARGING CYCLE .......................................................... 7
8.1 CHARGING CYCLE.........................................................................................................................8
9. SPECIFICATIONS AND ELECTRICAL RATINGS........................................................ 8
9.1 ELECTROMAGNETIC EMISSIONS....................................................................................................8
9.2 ELECTROMAGNETIC IMMUNITY ....................................................................................................9
9.3 RECOMMENDED SAFE DISTANCES ..............................................................................................11
9.4 TECHNICAL SPECIFICATIONS.......................................................................................................11
10. SPARE PARTS AND ACCESSORIES ....................................................................... 12
11. WARRANTY ........................................................................................................ 13
12. PACKAGING AND DISPOSAL INFORMATION....................................................... 13
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KEELER K-LED II
Consult instructions for use General warning sign
Date of manufacture Warning: Electricity
Manufacturer’s name and
address Warning: Floor level obstacle
Country of manufacture Warning: Non-ionizing
radiation
Waste Electrical and Electronic
Equipment (WEEE) recycling Warning: Optical radiation
This way up Warning: Hot surface
Keep dry Conformité Européene
Fragile Type B applied part
Do not use if package is
damaged Class II equipment
Temperature limit Atmospheric pressure
limitation
Authorised representative in
the European Community Humidity limitation
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.
Classification: CE: Class I
FDA: Class II
The information contained within this manual must not be reproduced in whole or part without the manufacturer’s
prior written approval. As part of our policy for continued product development we the manufacturer reserve the right
to make changes to specifications and other information contained in this document without prior notice.
This IFU is also available on the Keeler UK and Keeler USA websites.
Copyright © Keeler Limited 2021. Published in the UK 2021.
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KEELER K-LED II
1. INDICATIONS FOR USE
Indications for Use/Intended 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.
2. SAFETY
2.1 WARNINGS AND CAUTIONS
Please note that the proper and safe functioning of our instruments is only guaranteed if
both the instruments and their accessories are exclusively from Keeler Ltd. The use of other
accessories may result in increased electromagnetic emissions or reduced electromagnetic
immunity of the device and may lead to incorrect operation.
Observe the following precautions in order to ensure safe operation of the K-LED II Headlamp.
WARNINGS
• Check your Keeler product for signs of transport / storage damage prior to use.
• Never use the product if visibly damaged and periodically inspect it for signs of damage
or misuse.
• Do not shine directly into a person’s eye. Do not stare into the light when in use. May be
harmful to eyes.
• Do not hold magnifying glasses or any other optical system in front of the light.
• Do not use in the presence of flammable gases / liquids, or in an oxygen rich environment.
• This product should not be immersed in fluids.
• Do not disassemble or modify the battery. There are no serviceable parts inside.
• Do not dispose of battery in fire, puncture or short circuit.
• Do not use a battery that is deformed, leaking, corroded or visually damaged. Handle a
damaged or leaking battery with care. If you come into contact with electrolyte, wash
exposed area with soap and water. If it contacts the eye, seek medical attention immediately
• US Federal Law restricts this device to sale by or on the order of a physician or practitioner.
• This device is intended to be used only by suitably trained and authorised healthcare
professionals.
• Do not fit mains power adapter into a damaged mains outlet socket.
• Route power cords safely to eliminate risk of tripping or damage to user.
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KEELER K-LED II
• LED’s can reach high temperatures in use – allow to cool before handling.
CAUTION
• Use only genuine Keeler approved parts and accessories or device safety and performance
may be compromised.
• Use only Keeler approved batteries, chargers and power supplies as per the accessories
listed in section 11.
• Ensure the equipment is positioned in such a way that it can be disconnected from the
mains easily.
• The product has been designed to function safely when at an ambient temperature
between +10°C and +35°C.
• Keep out of the reach of children.
• To prevent condensation from forming, allow instrument to come to room temperature
before use.
• For indoor use only (protect from moisture).
• When replacing lithium battery pack, turn K-LED II off and attach new pack.
• Remove battery pack when device may not be used for prolonged periods.
• Do not charge battery in any environment where the temperature may exceed 40˚C or
fall below 0˚C. There are no user serviceable parts inside. Contact authorised service
representative for further information
• Ensure device is securely held in docking station to minimise risk of injury or damage to
equipment.
• Follow guidance on cleaning / routine maintenance to prevent personal injury / damage to
equipment.
• Switch off the electrical supply and disconnect from the mains electrical supply
before cleaning and inspection.
• At product end of life dispose of in accordance with local environmental
guidelines (WEEE).
• Dispose of batteries in line with local environmental regulations.
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.
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KEELER K-LED II
3. 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.
1. Wipe the external surface with a clean absorbent, non-shedding cloth dampened with
a de-ionised water / detergent solution (2% detergent by volume) or water / isopropyl
alcohol solution (70% IPA by volume). Avoid optical surfaces.
2. Ensure that excess solution does not enter the instrument. Use caution to ensure cloth is
not saturated with solution.
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
APower supply and adaptors
BRechargeable battery pack
CSingle charger storage unit
DDouble charger storage unit
ELED light source
FConnector
A
B C
D
Note: Loupes shown in this image
are not sold with the product.
F
E
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KEELER K-LED II
5. FITTING THE K-LED II HEADLAMP TO YOUR LOUPE FRAME
1. To remove the loupes from the frame,
hold the loupe bar between your thumb
and forefinger of one hand and pull away
from the hinge held in your other hand.
2. Attach the LED light to the loupe bar.
Ensure that the LED light is fitted
correctly and held securely in position.
3. Re-attach the loupes and LED light to
the frame hinge by holding the loupe
bar as before. Locate the hinge pins into
the loupe bar holes and push the loupes
onto the hinge.
4. If the LED light is to be used without
loupes, attach the light to the adaptor
PD bar. Attach the cable to the frame
using the strap provided.
5. Connect the LED light lead into the
connector port on top of the battery
pack. To remove the lead pull in the
direction of the arrows on the connector
do not twist or unscrew.
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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. Power up the charger and storage unit by plugging it in to a mains outlet.The green LED
shows the unit is powered.
2. Turn the battery pack off, and place into the charging well.
3. A yellow LED indicates the battery pack’s charge state.
8. K-LED II BATTERY PACK CHARGING CYCLE
The battery pack can be used at any time during the charging cycle and will automatically
resume charging when replaced in the charging well.
The battery pack can be left in the charger storage unit when it is not being used.The charger
will automatically stop charging the battery pack when fully charged.
Charging the battery pack
Green LED Charging storage
unit powered
Flashing yellow LED Top-up charge
No LED light Battery charged Solid yellow LED Rapid charge
Double charger storage unit Single charger storage unit
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KEELER K-LED II
Battery pack
Flashing yellow LED Battery requires charging
Belt clip
A clip is provided to allow the user to wear the battery pack on a belt.
8.1 CHARGING CYCLE
Single charger storage unit
The battery will take approximately 2 hours to fully charge.
Double charger storage unit
The battery will take approximately 2 hours to fully charge in charging well 1 and
approximately 4 hours to fully charge in 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.
Portable or mobile-type radio frequency communication units may have an adverse effect on
this instrument, resulting in malfunctioning.
Keeler Spectra Iris and K-LED are designed with similar electrical systems and therefore share
EMC characteristics and cautions
9.1 ELECTROMAGNETIC EMISSIONS
Guidance and manufacturer’s declaration – electromagnetic emissions
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.
Charging well 1
Charging well 2
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