Keeler K-LED II User manual

Keeler K-LED II
Headlamp
INSTRUCTIONS FOR USE
A world without vision loss

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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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KEELER K-LED II
Emissions test Compliance Electromagnetic environment – guidance
K-LED/
Spectra Only
RF emissions
CISPR 11
Group 1 The Keeler Spectra Iris and K-LED use 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
Harmonic emissions
IEC 61000-3-2
Class A The Keeler Spectra Iris and K-LED are suitable for use in
all establishments, including domestic establishments
and those directly connected to the public low- voltage
power supply network that supplies buildings used for
domestic purposes.
Voltage fluctuations / flicker
emissions IEC 61000-3-3
Complies
Charger only RF emissions
CISPR 14-1
Complies The Keeler Spectra Iris and K-LED is not suitable for
interconnection with other equipment.
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 IEC 55015 Test
level
Compliance
level
Electromagnetic
environment – guidance
K-LED/Spectra Only
Electrostatic
discharge (ESD).
IEC 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV contact
± 15 kV air
Floors should be wood, concrete
or ceramic tile.
If floors are covered with synthetic
material, the relative humidity
should be at least 30%.
Power frequency
(50/60 Hz)
magnetic field.
IEC 61000-4-8
30 A/m 30 A/m Power frequency magnetic fields
should be at a level characteristic
of a typical location in a typical
commercial or hospital environment.
Charger only
Electrical fast
transient/burst.
IEC 61000-4-4
± 1 kV for power
supply lines
± 1 kV for input/
output lines
± 1 kV for power
supply lines
N/A
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge.
IEC 61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
Mains power quality should be
that of a typical commercial or
hospital environment.

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KEELER K-LED II
Immunity test IEC 55015 Test
level
Compliance
level
Electromagnetic
environment – guidance
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines.
IEC 61000-4-11
<5% UT
(> 95% dip in UT) for
0.5 cycles
40% UT
(60% dip in UT) for
10 cycles
70% UT
(30% dip in UT) for
25 cycles
<5% UT
(> 95% dip in UT) for
0.5 cycles
40% UT
(60% dip in UT) for
10 cycles
70% UT
(30% dip in UT) for
25 cycles
Mains power quality should be
that of a typical commercial or
hospital environment.
If the user of the Keeler Spectra
Iris/K-LED requires continued
operation during power mains
interruptions, it is recommended
that the charger be powered from
an uninterruptible power supply.
Note: UTis the a. c. mains voltage prior to application of the test level.
Immunity
test
IEC 60601
Test level
Compliance
level
Electromagnetic environment
– guidance
Charger only Portable and mobile RF communications equipment
should be used no closer to any part of the Keeler
Spectra Iris/K-LED, including cables, than the
recommended separation distances calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance
d = 1.2 √ p
d = 1.2 √ p 80MHz to 800MHz
d = 2.3 √ p 800MHz to 2.7GHz
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 range².
Interference may occur in the vicinity of
equipment marked with the this symbol.
Conducted
RF IEC
61000-4-6
3 Vrms
150 kHz to
230 MHz
3 V
Spectra/K-LED only
Radiated
RF IEC
61000-4-3
10V/m
80MHz to
2.7GHz
10 V/m
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.
1Field 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 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. If abnormal performance is observed, additional measures may be necessary, such as re-orientating or
relocating the Keeler Spectra Iris/K-LED.
2Over the frequency range 150kHz to 230 MHz, field strengths should be less than 3 V/m.

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KEELER K-LED II
9.3 RECOMMENDED SAFE DISTANCES
Recommended separation distances between portable and mobile RF communications
equipment and the 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
between portable and mobile RF communications equipment (transmitters) and the Keeler
Spectra Iris/K-LED as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum output
power of transmitter (W)
Separation distance according to frequency of
transmitter (m)
150 kHz to 230MHz
d = 1.2√ p
80MHz to 800MHz
d = 1.2√ p
800MHz to 2.7GHz
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
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 guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
9.4 TECHNICAL SPECIFICATIONS
Power Supply
Input mains data: 100-240V – 50/60Hz
700mA
Power supply rating: 12V : 2.5amps
Operation: Continuous
Classification: Class II equipment
Type B applied part
Working distance: 340-500mm

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KEELER K-LED II
Environmental Conditions:
USE
35°C
10°C
90%
30%
1060 hPa
800 hPa
Shock (without packing) 10 g, duration 6 ms
STORAGE CONDITIONS
55°C
-10°C
95%
10%
1060 hPa
700 hPa
TRANSPORT CONDITIONS
70°C
-40°C
95%
10%
1060 hPa
500 hPa
Vibration, sinusoidal 10 Hz to 500 Hz: 0.5g
Shock 30 g, duration 6 ms
Bump 10 g, duration 6 ms
10. SPARE PARTS AND ACCESSORIES
Item Part Number
Power supply EP29-32777
Yellow filter cap EP39-57298
Battery pack 1919-P-5215
Twin charger 1941-P-5350
Single charger 1941-P-5385
Adaptor PD Bar 2001-P-7027

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KEELER K-LED II
11. 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.
12. PACKAGING AND DISPOSAL INFORMATION
Disposal of old electrical and electronic equipment
This symbol on the product or on its packaging and instructions indicates
that this product shall not be treated as household waste.
To reduce 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 ([phone]). (UK only).
Any serious incident that has occurred in relation to the device must be reported to
the manufacturer and the competent authority of your Member State.

A world without vision loss
Contact
Manufacturer
Keeler Limited
Clewer Hill Road
Windsor
Berkshire
SL4 4AA UK
Freephone 0800 521251
Tel [phone]
Fax[phone]
EP59-09812 Issue G Date of Issue 12/05/2021
USA Sales Office
Keeler USA
3222 Phoenixville Pike
Building #50
Malvern, PA 19355 USA
Toll Free 1 800 523 5620
Tel [phone]
Fax [phone]
India Office
Keeler India
Halma India Pvt. Ltd.
Plot No. A0147, Road No. 24
Wagle Industrial Estate
Thane West – 400604, Maharashtra
INDIA
Tel [phone]
China Office
Halma China Group
名称：沃迈（上海）机电有限公司
地址：上海市闵行区金都路1165弄
123号23幢一号厂房三层B座
电话：[phone]
Visiometrics, S. L., Vinyals, 131
08221 Terrassa, Spain