Keeler K-LED II Headlamp Loupe Practice Light System Instructions

Keeler K-LED II Headlamp Loupe Practice Light System

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.

 SAFETY

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 fl ammable gases / liquids, or in an oxygen rich environment.
•  This product should not be immersed in fl uids.
•  Do not disassemble or modify the battery. There are no serviceable parts inside.
•  Do not dispose of battery in fi re, 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 fi t mains power adapter into a damaged mains outlet socket.
•  Route power cords safely to eliminate risk of tripping or damage to user.
• 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 authorized service representative for further information
•  Ensure device is securely held in a docking station to minimize risk of injury or damage to equipment.
•  Follow the 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.

 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.

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
  4. cloth.
  5.  Safely dispose of used cleaning materials.
  6.  Do not operate LED until thoroughly dry.

K-LED II HEADLAMP AND CHARGING UNITS

DESCRIPTION OF THE PRODUCT

•  Power supply and adaptors
•  Rechargeable battery pack
•  Single charger storage unit
•  Double charger storage unit
•  LED light source
•  Connector

Note:
Loupes shown in this image are not sold with the product.

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 befsaore. 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.

 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).

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.

 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 LED light Battery charged
• Flashing yellow LED Top-up charge Solid
• yellow LED Rapid charge
• Flashing yellow 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.

SPECIFICATIONS AND ELECTRICAL RATINGS

The Keeler KLED II and chargers is a medical electrical instruments. The instrument requires special care concerning electromagnetic compatibility (EMC). This Section describes its suitability in terms of the 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 caution

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.

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.

ELECTROMAGNETIC IMMUNIT Y
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.
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% U T

(> 95% dip in U T) for

0.5 cycles 40% U T

(60% dip in U T) for

10 cycles 70% U T

(30% dip in U T) for

25 cycles

| <5% U T

(> 95% dip in U T) for

0.5 cycles 40% U T

(60% dip in U T) for

10 cycles 70% U T

(30% dip in U T) 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.

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. 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 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. 2 Over the frequency range 150kHz to 230 MHz, field strengths should be less than 3 V/m.

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

Environmental Conditions:

USE

| ****

10°C

| ****

35°C

| ****

30%

| 90%| ****

800 hPa

| 1060 hPa
| Shock (without packing)| 10 g, duration 6 ms
STORAGE CONDITIONS
| ****

-10°C

| ****

55°C

| ****

10%

| 95%| ****

700 hPa

| 1060 hPa
TRANSPORT CONDITIONS
| ****

-40°C

| ****

70°C

| ****

10%

| 95%| ****

500 hPa

| 1060 hPa
| Vibration, sinusoidal| 10 Hz to 500 Hz: 0.5g
| Shock| 30 g, duration 6 ms
| Bump| 10 g, duration 6 ms

SPARE PARTS AND ACCESSORIES

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.

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 (+44 1691 676124). (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.

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