Keeler K-LED II Instructions For Use Manual

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Keeler K-LED II

Headlamp

Instructions for use

Page 2

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

Click on the headings above to go directly to that section. Use the buttons on the right to navigate the document.

Clicking ‘Home’ from any page brings you back to this contents page.

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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.

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

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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

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

) for 0.5 cycles

(60% dip in UT ) for 5 cycles

70% U (30% dip in U

<5% U

) for 25 cycles

(>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

) for 0.5 cycles

(60% dip in UT ) for 5 cycles

70% U (30% dip in U

<5% U

) for 25 cycles

(>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.

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

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.

objects and people.

150 kHz to 80MHz d = 1.2√ p

Separation distance according to frequency of transmitter

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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