Keeler K-LED II Manuale utente

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

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.

3 EN

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.

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.

5 EN

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

B C

Note: Loupes shown in this image

are not sold with the product.

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.

7 EN

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

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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