Keeler KSL-H, KSL-Z, Slit Lamp Instructions For Use Manual

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&
SLIT LAMP
INSTRUCTIONS FOR USE
Digital IFU supplement
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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.
Copyright © Keeler Limited 2015. Published in the UK 2015.
KSL-H AND KSL-Z by KEELER
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CONTENTS
Please click on the contents to go straight to your chosen section or navigate by using the ‘Next’ and ‘Back’ buttons to the right. Clicking on ‘Home’ will bring you back to this page.
Introduction 2 Symbols used in these Instructions for Use 3
including the Slit Lamp and packaging
Indications for use 4
Intended use/purpose of instrument Brief description of the instrument
Safety 5 Cleaning and disinfection instructions 7
Transport, storage and working conditions
Installation and setup of digital unit 8 Controls 11 Electromagnetic emissions 12 Technical Specification 14 Contact, packaging and disposal Information 15
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1 INTRODUCTION
Thank you for choosing this Keeler product.
These Instructions for Use are aimed solely at hardware installation on the slit lamp of the digital camera assembly (DCA), which to display captured images needs to be used in conjunction with CE compliant or FDA cleared imaging software installed on a medically approved PC. For detailed instructions on use of the Keeler Desktop Slit Lamp please refer to the Slit Lamp Manual EP59-70040.
Please read this manual carefully before using your Keeler Slit Lamp, this will ensure the safety of the patient and ensure you get the best performance from this precision optical device.
This manual should be read in conjunction with the Keeler Slit Lamp H- series IFU (EP59-70040) or Keeler Slit Lamp Z-series IFU (EP59-
70043). Contact your distributor if do not have a copy of this IFU.
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2 SYMBOLS USED IN THESE INSTRUCTIONS FOR USE AND THE PACKAGING OF THE UNIT:
Manufacturer’s name and address
Mandatory action sign
Follow Instructions for Use
Optical radiation hazard
Trip Hazard
Hot surface
General warning sign
Type B Applied Part
Non-ionizing radiation
Date of manufacture
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
This way up
Material suitable for recycling
Fragile
The symbol on the Product or on it’s Packaging and instructions indicates it was put on the market place after August 2005 and this product shall not be treated as Household Waste
Operating Instructions
+
Exposure +
-
Exposure –
REF
SN
Keep dry
Reference Number
Serial Number
PC connection
Camera connection
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3 INDICATIONS FOR USE
5 BRIEF DESCRIPTION OF THE INSTRUMENT
This Keeler Slit Lamp is an AC-powered slit lamp biomicroscope and is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment.
This device is intended to be used only by suitably trained and authorised healthcare professionals.
Caution: Federal Law restricts this device to sale by or on the order of a physician or practitioner.
4 INTENDED USE / PURPOSE OF INSTRUMENT
The Slit Lamp is an instrument consisting of a light source that can be focused to shine a thin sheet (slit) of light into the eye. It is used in conjunction with a biomicroscope. The lamp facilitates an examination of the anterior segment, or frontal structures and posterior segment, of the human eye, which includes the eyelid, sclera, conjunctiva, iris, natural crystalline lens, and cornea. The binocular Slit Lamp examination provides stereoscopic magnified view of the eye structures in detail, enabling anatomical diagnoses to be made for a variety of eye conditions. The digital camera allows pictures to be captured of this pathology.
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This Keeler Slit Lamp can either be mounted onto a custom table top supplied by Keeler or can be mounted on a third parties table top (refraction unit) by suitably trained technicians.
The Keeler Digital Slit Lamp consists of multiple subassemblies; Illumination Tower; Observation System; XYZ Translation Base; Chinrest Assembly, Digital Camera Assembly and a Table Top with Power Supply and Accessory Drawer, (not applicable to the refraction stand unit).
The light intensity is controlled by a variable rheostat located on the XYZ Translation Base. There are a number of selectable filters allowing the user to control the characteristics of the examination light. The digital module is fitted between the magnification drum and viewing optics and is used to capture an image of the patients pathology.
Many ophthalmic instruments illuminate the eye with intense light. The light intensity on the Keeler Slit Lamp is continuously adjustable from maximum to zero. In addition there is an infra-red filter incorporated in the illumination system of the Keeler Slit Lamp H-series to reduce IR light levels.
The Keeler Slit Lamp is designed and built in conformity with EC Directive 93/42/EEC and the ISO 9000 and ISO 13485 series of quality standards.
The ‘CE’ (European Community) mark attests that the Keeler Slit Lamp complies with the provisions of the EC Directive 93/42/EEC.
Classification: CE Regulation 93/42 EEC: Class I FDA: Class II IEC/EN Standard 60601-1: H-series - Safety Class II Application part: Type B Operation mode: continuous operation
Production processes, testing, start-up, maintenance, and repairs are conducted in strict conformity with the applicable laws and international reference standards.
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PHOTO TOXICITY
Because prolonged intense light exposure can damage the retina, the use of the device for ocular examination should not be unnecessarily prolonged, and the
brightness setting should not exceed what is needed to provide clear visualization of the target structures. This device should be used with filters that eliminate UV radiation (< 400 nm) and, whenever possible, filters that eliminate short-wavelength blue light (<420 nm).
The retinal exposure dose for a photochemical hazard is a product of the radiance and the exposure time. If the value of radiance were reduced in half, twice the time would be needed to reach the maximum exposure limit.
While no acute optical radiation hazards have been identified for slit lamps, it is recommended that the intensity of light directed into the patient’s eye be limited to the minimum level which is necessary for diagnosis. Infants, aphakes and persons with diseased eyes will be at greater risk. The risk may also be increased if the person being examined has had any exposure with the same instrument or any other ophthalmic instrument using a visible light source during the previous 24 hours. This will apply particularly if the eye has been exposed to retinal photography.
CAUTION- The light emitted from this instrument is potentially hazardous. The longer the duration
of exposure, the greater the risk of ocular damage. Exposure to light from this instrument when operated at maximum intensity will exeed the recommended maximum exposure (RME) of 2.2J/ cm², unless additional action is taken by the user to minimise exposure, after 1.40 min (70 seconds for Z-series). The risk of retinal injury at an exposure of 2.2J/cm² is not high, but becasue some patients may be more susceptible that others, caution is advised if this radiant exposure value is exceeded. However, because of significant risk of injury at exposures exeeding 10 J/cm², the user should avoid exposures longer that 6.4 mins (5.3 mins for Z-Series) when using the ancillary 90D lens.
The relative spectra output for Keeler Slit Lamp H-series and Z-series is provided below
Figure 1. Relative
Spectral output Keeler
Slit Lamp H-series
It is well established that exposure of the eye to intense light sources for extended periods of time poses a risk of retinal photic injury/ocular damage.
Figure 2. Relative
Spectral output Keeler
Slit Lamp Z-series
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WARNINGS AND CAUTIONS
Observe the following prescriptions in order to ensure safe operation of the instrument For the safety warning regarding the Keeler Slit Lamp please consult the Keeler Slit Lamp IFU.
• It is important that the Digital Camera Assembly is configured and installed/put
into service, in accordance with the instructions/guidance provided herein and is used only in the configuration as supplied.
• Do not exceed maximum recommended exposure time.
WARNINGS
• Never use the instrument if visibly damaged and periodically inspect it for signs of damage or misuse.
• Check your Keeler product for signs of transport / storage damage prior to use.
• Do not use in the presence of flammable gases / liquids, or in an oxygen rich environment.
• 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.
• This product should not be immersed in fluid.
• Repairs and modifications to the instrument must be made only by the specialized technicians of the manufacturer’s Technical Service Centre or by personnel trained and authorised by the manufacturer. The manufacturer declines any and all responsibility for loss and/or damages resulting from unauthorised repairs; furthermore, any such actions will invalidate the warranty.
• Route power cords safely to eliminate risk of tripping or damage to user.
• Before any cleaning of the instrument or the base unit ensure the power lead is disconnected.
• Should the instrument suffer shocks (for example, should it accidentally fall), and the optical system or the illumination system are damaged it may be necessary to return the instrument to the manufacturer for repair.
• Care should be taken when handling halogen bulbs. Halogen bulbs can shatter if scratched or damaged.
• After removal of the bulb, do not touch the Slit Lamp bulb electrical contacts and patient simultaneously.
• The owner of the instrument is responsible for training personnel in its correct use.
• Ensure the instrument or instrument table is placed on a level and stable surface.
• Use only genuine Keeler approved parts and accessories or device safety and performance may be compromised.
• Shut down after every use. In case the dust cover is used: risk of overheating.
• For indoor use only (protect from moisture).
• Electrical equipment can be affected by electromagnetic interference, for example videostream may freeze for one minute or more. If this occurs whilst using this equipment, switch the unit off and reposition. Essential performance is determined as continuous videostream which cannot be interrupted for longer than one minute.
• Do not touch accessible connectors and the patient simultaneously.
• As the Digital Camera Assembly is medical equipment, special precautions are needed regarding EMC (electromagnetic compatibility)
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• Despite the testing of the Digital Camera Assembly that has been undertaken, normal operation of the Digital Camera Assembly can be affected by other electrical/electronic equipment and portable and mobile RF communications equipment.
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• Keeler digital KSL is not intended to be used with wireless technology. Do not plug a wireless dongle into USB port. It is advisable to disable wireless technology on the computer to prevent unauthorised access to the camera.
• Keeler digital KSL cannot be used in the vicinity of sources known to cause electromagnetic disturbance (magnetic resonance imaging, computed tomography, radio-frequency identification, metal detectors, electronic article surveillance and other electromagnetic security systems). Do not bring the Keeler digital Slit lamp into magnetic resonance environment.
• The Digital Camera Assembly should not be used adjacent to or stacked with other equipment. If adjacent or stacked use with other equipment is necessary, the Digital Camera Assembly and the other equipment should be observed/monitored, to verify normal operation in the configuration in which it will be used.
7 CLEANING AND DISINFECTION INSTRUCTIONS
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.
8 TRANSPORT, STORAGE AND WORKING CONDITIONS
The following ambient condition limits are recommended for the Keeler Slit Lamp, for transport and storage it is recommended that the Slit Lamp is kept in its original manufacturers packaging.
WORKING ENVIRONMENT
+10°C to +35°C 30% to 75% relative humidity
Before any cleaning of the instrument or the base unit, ensure
the power leads and USB cables are disconnected.
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.
TRANSPORT AND STORAGE CONDITIONS
Transport: -10°C to +60°C Storage: -10°C to +55°C
Before use, the Slit Lamp should be allowed to adjust to the ambient room temperature for several hours. This is especially important when the unit has been stored or transported in a cold environment; this can cause severe condensation to develop on the optical elements.
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9 INSTALLATION OF DIGITAL UNIT
For ‘Digital Ready’ variants of the Keeler Slit Lamp a Digital Camera Assembly (DCA) must be purchased separately, contact Keeler or your local distributor for details.
Set up the Slit Lamp as directed in the Instructions For Use (IFU) EP59-70040, Contact your distributor if you are unable to locate a copy of these Instructions.
1 Install the Digital Camera Assembly (DCA) - carefully remove the
eyepiece assembly from the magnification block by unscrewing the securing knob at the same time as supporting the eyepieces. The eyepieces assembly is a dovetail type fit to the magnification block.
securing knob
2 Fit the digital camera assembly to the rear of the magnification
block and tighten the securing knob to hold it in place.
3 Re-fit the eyepiece assembly to the rear of the DCA and secure
it by tightening the securing knob.
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Care must be taken to avoid getting any dirt or dust on any of the optical components.
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4 Rotate the swing arm to either side of the unit, and with a suitable
philips screw driver remove the cable channel cover plate.
6 Connect the shorter USB cable (3020-P-7107) to the socket on
the underside of the DCA and to the appropriate socket on the USB hub located on the Slit Lamp base. Ensure that there is plenty of slack at the USB hub end to allow Slit Arm rotation.
to camera
5 Remove the cover to the USB hub on the Slit Lamp base by undoing the
small Phillips head screw and lifting off the cover.
7 Route the cable in the groove in the Slit Lamp arm and replace
the cover plate.
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8 Connect the longer USB cable for connection to the PC to the hub and
replace the USB hub cover plate, this secures the cables.
to PC
10 Fit the background illumination fibre optic cable, The short end
to the top of the lamp housing, the long end to the fibre optic swing arm adjacent to the mirror.
long end
KSL-H SERIES SLIT LAMP
9 Clip the auxiliary diffuser and blue filter in place on the Slit Lamp
tower upright posts, above the level of the mirror. Align the slot to the flattened post section.
short end
11 If CE compliant or FDA cleared imaging software has been
installed, connect the PC USB cable to the PC.
KSL-Z SERIES SLIT LAMP
12 No fitting of the background light is required
as the Slit Lamp comes fully assembled.
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10 CONTROLS
BACKGROUND ILLUMINATION ADJUSTMENT, KSL-H SERIES SLIT LAMP
BACKGROUND ILLUMINATION ADJUSTMENT, KSL-Z SERIES SLIT LAMP
EXPOSURE AND REVIEW BUTTONS
Pressing these buttons provides adjustment of the camera exposure
Increase exposure time (milliseconds) Review freeze frame images forwards
CAPTURE BUTTON
Press once to ‘freeze frame’ Use image review buttons to select best frame Press again to capture selected frame
KEYBOARD SHORTCUTS
Ctrl + Alt + Shift : F6 Right eye F7 Left eye F8 Freeze frame / Trigger F9 Longer exposure time F9 Review freeze frame images forwards F10 Shorter exposure time F10 Review freeze frame images backwards
Decrease exposure time (milliseconds) Review freeze frame images backwards
DIGITAL ACCESSORIES/SPARES
USB Cable camera to hub 3020-P-7107 USB cable hub to PC 3020-P-7029 External illuminator, H-series 3020-P-5039 Auxiliary diffuser, H-series 3020-P-7034 Auxiliary blue filter, H-series 3020-P-7035
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11 ELECTROMAGNETIC EMISSIONS
Guidance and manufacturer’s declaration – electromagnetic emissions
The Digital Camera Assembly is intended for use in the electromagnetic environment specified below. The customer or user of the Digital Camera Assembly should ensure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations / flicker emissions IEC 61000-3-3
Group 1 The Digital Camera Assembly uses RF energy
Class B The Digital Camera Assembly is suitable for use
Not Applicable
Not Applicable
only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
in a professional healthcare facility environment. The Digital Camera Assembly is not intended for use in home environment.
Guidance and manufacturer’s declaration – electromagnetic immunity
The Digital Camera Assembly is intended for use in the electromagnetic environment specified below. The customer or user of the Digital Camera Assembly should assure that it is used in such an environment.
Immunity test
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
Note: UT is the a. c. mains voltage prior to application of the test level.
IEC 60601 Test level
± 6 kV contact ± 8 kV air
± 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
T
(> 95% dip in UT) for 0.5 cycle
40% U
T
(60% dip in UT) for 5 cycles
70% U
T
(30% dip in UT) for 25 cycles
<5% U
T
(>95% dip in UT) for 5 s
3 A/m 3 A/m Power frequency magnetic fields
Compliance level
± 6 kV contact ± 8 kV air
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Electromagnetic environment
- guidance
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Mains power quality should be that of a typical professional healthcare facility environment.
Mains power quality should be that of a typical professional healthcare facility environment.
Mains power quality should be that of a typical professional healthcare facility environment. If the user of the Digital Camera Assembly requires continued operations during power mains interruptions, it is recommended that the Digital Camera Assembly be powered from an uninterruptible power supply.
should be at a level characteristic of a typical location in a typical professional healthcare facility environment.
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Guidance and manufacturer’s declaration – electromagnetic immunity
The Digital Camera Assembly is intended for use in the electromagnetic environment specified below. The customer or user of the Digital Camera Assembly should assure that it is used in such an environment.
Immunity test
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3
Note: At 80MHz and 800MHz, the higher frequency range applies. 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 Digital Camera Assembly is used exceeds the applicable RF compliance level above, the Digital Camera Assembly should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orientating or relocating the Digital Camera Assembly.
2
Over the frequency range 150kHz to 80 MHz, field strengths should be less than 3 V/m.
IEC 60601 Test level
3 Vrms 150kHz to 80MHz
3 V/m 80MHz to
2.5GHz
Compliance
Electromagnetic environment - guidance
level
Portable and mobile RF communications equipment should be used no closer to any part of the Digital Camera Assembly, including cables, than the recommended separation distances calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
3 V d = 1.2 √ p
3 V/m 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 this symbol.
Recommended separation distances between portable and mobile RF communications equipment and the Digital Camera Assembly
The Digital Camera Assembly is intended for the use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Digital Camera Assembly can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Digital Camera Assembly 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 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
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
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: At 80MHz and 800MHz, the separation distance for the higher frequency applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
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12 TECHNICAL SPECIFICATION
DIGITAL SYSTEM CAMERA
Camera Resolution 2048 x 1536
Pixel Class: 3 MPixel
Sensor size: 1/1.8"
Sensor Technology: CMOS COLOR
PC Specification Medically approved PC
CPU: Intel Core 2 Duo 2.33GHz 15 or higher
Memory: 4Gb RAM or higher
USB port: 3.0 or higher
Hard disk speed 5200 rpm or higher
Operating system: Microsoft Windows XP Service pack 3 or
higher,
Windows 7/8 32-Bit or 64 Bit
Software requirements CE compliant or FDA cleared camera imaging software
WEIGHT, PACKED (APPROX.)
Digital Slit Lamp complete 20.0Kg, 75 x 54 x 45cm W x D x H
POWER SUPPLY Part number
Power supply unit
Power supply output 24V DC: 2.2 amps must be IEC/EN 60601 compliant
Complies with Electrical Safety (Medical) BS EN 60601-1
If the Digital camera Assembly is used with power supplies or cables other than those supplied, this may result in increased emissions or decreased immunity of the Digital Camera Assembly in relation to EMC performance.
It should be noted that neither the power supply nor the cables provided with the Digital Camera Assembly should be used on other equipment. To do so may result in increased emissions or decreased immunity of the other equipment in relation to EMC performance.
Switch Mode, (100V-240V input) +/- 10% multi plug compliant to EN60601-1 EN 61000-6-2, EN 61000-6-3
Electromagnetic compatibility EN 60601-1-2
Ophthalmic instruments - Fundamental requirements and test methods ISO 15004-1
Ophthalmic instruments - Optical radiation hazard ISO 15004-2
3020-P-5020/ 3020-P-7033
ENVIRONMENTAL
Temperature Humidity Pressure
Use +10°C to +35°C 30% to 90% 800 hpa to 1060 hpa
Storage -10°C to +55°C 10% to 95% 700 hpa to 1060 hpa
Transport -10°C to +60°C 10% to 95% 500 hpa to 1060 hpa
PROTECTION AGAINST INGRESS IPxO
CLASS II ME EQUIPMENT
Insulation between mains parts and the functional earth provide at least two means of protection.
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13 CONTACT, PACKAGING AND DISPOSAL INFORMATION
MANUFACTURER
Keeler Limited Clewer Hill Road Windsor Berkshire SL4 4AA UK
Freephone 0800 521251 Tel +44 (0) 1753 857177 Fax +44 (0) 1753 827145
USA SALES OFFICE
Keeler USA 3222 Phoenixville Pike Building #50 Malvern, PA 19355 USA
Toll Free 1 800 523 5620 Tel 1 610 353 4350 Fax 1 610 353 7814
INDIA OFFICE
Keeler India Halmer India Pvt. Ltd. B1-401, Boomerang, Chandivali Andheri (East) Mumbai – 400072 India
Tel +91 (22) 6708 0405 Fax +91 (99303) 11090
CHINA OFFICE
Keeler China, 1012B, KunTai International Mansion, 12B ChaoWai St. Chao Yang District, Beijing, 10020 China
Tel +86 (10) 51261868 Fax +86 (10) 58790155
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.
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).
EP59-70041 Issue 8
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