Keeler K-LED II User manual
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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 .................................. 11
• Power supply assembly
• Charging battery packs ................................................ 12
8. Cleaning instructions .......................................................... 14
9. Specifications and electrical ratings .................................. 15
• Electrical specifications
• Transport, storage and operation
10. Annex I – EMC statement and guidelines ......................... 16
11. Spare parts and accessories ................................................ 21
12. Warranty .............................................................................. 22
13. Contact and disposal information ..................................... 23
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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.
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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.
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3. 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
Double insulated
Manufacturer's name and address
This Symbol on the product or on its packaging
and instructions indicates that it was put on the
market place after August 2005 and that this
product shall not be treated as Household Waste
Type B protections against shock
Mandatory action sign
Follow instructions for use
High voltage
Trip hazard
Optical radiation hazard
Hot surface
This way up
Keep dry
Fragile
Material suitable for recycling
Keep dry
Material suitable for recycling
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4. Safety
Device classification
CE Regulation 93/42 EEC: Class I
FDA: Class II
Carefully read this Instruction Section before using your Keeler
product. For your own safety and that of your customers
observe all cautionary information provided in this section. The
following information is intended to highlight potential safety
hazards that can be associated with misuse, or damage.
Warnings and cautions
Warning
• Check your Keeler product for signs of transport / storage
damage prior to use
• Do not use if the product is visibly damaged, and periodically
inspect for signs of damage
• 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 order of a
physician or practitioner
Do not fit mains power adapter into a damaged mains
outlet socket
Route power cords safely to eliminate risk of tripping or
damage to equipment
LED’s can reach high temperatures in use – allow to cool
before handling
After removal of the LED do not
touch the LED contacts and the
patient simultaneously
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4. Safety
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
• Dispose of batteries in line with local environmental
regulations
• At product end of life dispose of in accordance with local
environmental guidelines (WEEE)
Note: Lithium Ion batteries contain no toxic heavy metals
such as mercury, cadmium or lead
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6. 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,
as shown.
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.
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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,
attach the Light to the Adaptor PD bar as shown. Attach the
cable to the frame using the Velcro strap provided.
5 Connect the LED light lead into the
connector port on top of the battery pack.
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Double charger storage unit
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
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7. 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
No yellow LED Battery charged
Flashing yellow LED Top-up charge
Solid yellow LED Rapid charge
Battery pack
Flashing LED Battery requires charging
Belt clip
A clip is provided to allow the user to wear the
battery pack on a belt.
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.
Charging
well 2
Charging
well 1
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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
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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
range
-40°C
to +70°C
-10°C
to +55°C
+10°C
to +35°C
Relative
humidity 10% to 95% 10% to 95% 30% to 75%
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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.
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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
discharge (ESD).
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 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%.
Electrical fast
transient/burst.
IEC 61000-4-4
± 2 kV for power supply lines
± 1 kV for input/output lines
± 2 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)
N/A
Mains power quality should be that of a typical commercial
or hospital environment.
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 5 cycles
70% UT
(30% dip in UT ) for 25 cycles
<5% UT
(>95% dip in UT) for 5 s
<5% UT
(> 95% dip in UT) for 0.5 cycles
40% UT
(60% dip in UT ) for 5 cycles
70% UT
(30% dip in UT ) for 25 cycles
<5% UT
(>95% dip in UT) for 5 s
Mains power quality should be that of a typical commercial or
hospital environment.
If the user of the Keeler K-LED II charger requires continued
operation during power mains interruptions, it is
recommended that the charger be powered from an
uninterruptible power supply.
Power frequency
(50/60 Hz) magnetic
field. IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic fields should be at a level
characteristic of a typical location in a typical commercial or
hospital environment.
Note UT is the a.c. mains voltage prior to application of the test level.
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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
Single / double
charger only
RF emissions
CISPR 11
Group 1 The Keeler K-LED II chargers use RF energy only for their internal function.
Therefore, the RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B The Keeler K-LED II chargers use RF energy only for their internal function.
Therefore, the RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Complies
¹ Refer to section 1.1.4 of the Guide for the EMC Directive 2004/108/EC (published 21st May 2007).
The Keeler K-LED II is considered to be inherently EMC benign¹, and therefore is not covered by the statements in this section.
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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 user should assure
that they are used in such an environment.
Immunity test IEC 60601 Test level Compliance level Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80MHz to 2.5GHz
3 V
3 V/m
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
d = 1.2 √ p
d = 1.2 √ p 80MHz to 800 MHz
d = 2.3 √ p 800MHz 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.
² Over the frequency range 150kHz to 80 MHz, field strengths should be less than 3 V/m.
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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
output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80MHz
d = 1.2√ p
80MHz to 800MHz
d = 1.2√ p
800MHz to 2.5GHz
d = 2.3√ p
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.2 1.2 2.3
10 3.7 3.7 7.4
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 guide lines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.
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