Keeler K-LED II Instructions For Use Manual

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Keeler K-LED II
Headlamp
Instructions for use
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Contents
1. Copyright and trademarks ................................................... 3
• Product description
• Device classification
• Warnings
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
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
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
Keep dry
Material suitable for recycling
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
Follow instructions for use
High voltage
Trip hazard
Optical radiation hazard
Hot surface
This way up
Keep dry
Type B protections against shock
Mandatory action sign
Fragile
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)
• 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
• Dispose of batteries in line with local environmental
regulations
• At product end of life dispose of in accordance with local
environmental guidelines (WEEE)
inspection
• 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
Note: Lithium Ion batteries contain no toxic heavy metals
such as mercury, cadmium or lead
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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
B
A
C
D
E
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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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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
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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
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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
Charging well 2
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 1
Belt clip
A clip is provided to allow the user to wear the
battery pack on a belt.
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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
Relative
humidity
-40°C
to +70°C
10% to 95% 10% to 95% 30% to 75%
-10°C
to +55°C
+10°C
to +35°C
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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
Electrical fast transient/burst. IEC 61000-4-4
Surge. IEC 61000-4-5
Voltage dips, short interruptions and voltage variations on power supply input lines. IEC 61000-4-11
Power frequency (50/60 Hz) magnetic field. IEC 61000-4-8
± 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%.
± 2 kV for power supply lines ± 1 kV for input/output lines
± 1 kV line(s) to line(s) ± 2 kV line(s) to earth
<5% U (> 95% dip in U
40% U
T
) for 0.5 cycles
T
T
(60% dip in UT ) for 5 cycles
70% U (30% dip in U
<5% U
T
) for 25 cycles
T
T
(>95% dip in UT) for 5 s
± 2 kV for power supply lines N/A
± 1 kV line(s) to line(s) N/A
<5% U (> 95% dip in U
40% U
T
) for 0.5 cycles
T
T
(60% dip in UT ) for 5 cycles
70% U (30% dip in U
<5% U
T
) for 25 cycles
T
T
(>95% dip in UT) for 5 s
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.
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.
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
RF emissions CISPR 11
Single / double charger only
RF emissions CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations / 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.
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.
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
Class A
Complies
interference in nearby electronic equipment.
¹ Refer to section 1.1.4 of the Guide for the EMC Directive 2004/108/EC (published 21st May 2007).
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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
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.
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3
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.
3 Vrms 150 kHz to 80 MHz
3 V/m 80MHz to 2.5GHz
3 V
3 V/m
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:
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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
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.
150 kHz to 80MHz d = 1.2 p
Separation distance according to frequency of transmitter
m
80MHz to 800MHz d = 1.2 p
800MHz to 2.5GHz d = 2.3 p
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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
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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.
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13. Contact and disposal information
Keeler Limited Clewer Hill Road Windsor Berkshire SL4 4AA England
Freephone: 0800 521 251 Tel: +44 (0)1753 857177 Fax: +44 (0)1753 827145
Keeler Instruments Inc 3222 Phoenixville Pike Building #50 Malvern, PA 1 USA
Toll Free: 1 800 523 5620 Tel: 1 610 353 4350 Fax: 1 610 353 7814
Disposal of old Electrical and Electronic Equipment
(Applicable in the European Union and other European Countries with
separate Collection Systems).
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.
9355
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 (+44 1691 676124).
EP59-09812 Issue D
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