Instructions for use ENG
Contents
1. E Brandon BRILLIANT BY DESIGN Instructions for use SMA CLED11 PPS Examination light SYMBOLS The warning symbols indicate all instructions that are important for safety Failure to comply with them can lead to injury damage to the luminaire or the equipment In combination with the following signal words the warning symbols means DANGER Can lead to death or serious injury WARNING Can lead to injury Comply with operating Instructions CE conformity mark Mainswitch on Mainswitch off Appliance of protection class ll Storage humidity Storage temperature Disposal Manufacturer VARIANTS CLED11FX PPS CONTENTS 1 OA Edy ING HAWG TIONS iio ectedtie Maeta n acondeudshwundecbaccaascatnus nn otderatseaneincoacdaanceteas ack 3 1 1 Mended US Erase oni N ee ne a E Ea 3 KA USERDONG Siei e Tae OR reo TC eR Oe ee en nee ee een ee eae ree ee 3 L SATSLYWNSMUGTION Sieve hoses shetiasetc ce a a a a o T 3 tA Waning IEVESTS e E AN 4 2 SCOPRE OFC UPPL zoana a a a a eee eRe ere ee 4 2 1 GEED MPA actos acini eee osteo atybas gaan coc etsoesb oa sessecsea btu apteaas peat emad veises ce satyiane dese macaaeeseamasaceeseataetiiees 4 Zio GLEDIISA PRPS soa a a ia eet kl etl a seal eee a alee 4 3 WY OS epee etter neki et eater eee ent i er eee tree rac eee scien een ec ree in eee eee cee ener een eee a eee ree ee 4 4 OPERATION ceaiin a a ucedembcnaaata a taeda saecsiona tb e 4 5 DISINFECTION CLEA2. life LED User profiles All By manufacturer service only Electrician see type label of the luminaire 50 60Hz 13W 18VA 0 09A 0 72 40 000 Ix 18cm 7 1 9cm 3 54 4400K gt 93 gt 90 lt 180 W m 10 20 tolerance 20 C to 70 C 4F to 158 F 10 C to 35 C 50 F to 95 F max 5 1 4kg 3 09 Ib 1 4kg 3 09 Ib Continuous operation Schutzklasse II IP 20 Class EN IEC 60601 1 EN IEC 60601 2 41 EN IEC 60601 1 2 12276 30 000h L70 B50 12 ELECTROMAGNETIC COMPATIBILITY EMC Electromagnetic emission guidelines The medical device is intended for operation in an electromagnetic environment such as the one specified below The user must ensure that it is operated in such an environment Emissions I accordance Electromagnetic environment High frequency emissions Group 1 The medical device uses HF energy exclusively for its internal function This CISPR 11 means that its HF emissions are very low and it is unlikely that adjacent electronic devices will receive interference The medical device is intended for use in all facilities including residential CISPR 11 buildings and facilities that are directly connected without a transformer to the same low voltage network as residential buildings Emissions from harmonics Class A IEC 61000 3 2 fluctuations flicker IEC 61000 3 3 Electromagnetic interference resistance guidelines The med
3. regulations and the requirements of national bodies with responsibilities for hygiene and disinfection 6 SAFETY INSPECTIONS Electric shocks are life threatening gt Remove the connector from the power supply and put the switch in the OFF position The connector cable must be checked for damage at least once per year Maintenance and repairs must only be carried out by qualified electricians The corresponding user profile is described in Chapter 1 Safety instructions 7 DEMOUNTING Electric shocks are life threatening gt Remove connector from the power supply and put the switch in the OFF position before demounting 7 1 Disposal Do not dispose the luminaire in household refuse Dispose the luminaire at a disposal point in accordance with local regulations or take them to a dealer that provides an appropriate disposal service Cut off the cable directly on the housing as The products listed above are more than 95 recyclable The luminaires have been constructed to be compatible with recycling so that a high proportion of the materials used in these products can be recycled or converted into energy after the end of service life They contain no materials that are dangerous or that need to be monitored 8 ACCESSORIES 16mm MOBILE BASE HWSCAM14255 COOLVIEW WALL BRACKET ASSEMBLY CABW14271 Rail Mount Bkt 16mm CABKTR16 1 Meter Medirail kit Boxed with endcaps CADIS TIAI 16mm Desk Clamp OABKT
4. 16D 9 ADDITIONAL INSTRUCTIONS The luminaire itself is maintenance free You can obtain additional documents about this product from the manufacturer upon request These luminaires do not affect any other devices To save energy the luminaire should only be switched on when actually needed 10 TROUBLESHOOTING Fault Possible cause The luminaire does not light Contact problem The luminaire does not light Lamp defective The luminaire does not light No mains voltage 11 TECHNICAL DATA Electrical Nominal input voltage Frequency range Power consumption Input current Power factor Lighting data Central illuminance Ec at 1 0m 3 28 feet distance Light field diameter d10 at 1 0m 3 28 feet distance Light field diameter d50 at 1 0m 3 28 feet distance Colour temperature Colour rendering index Ra Colour rendering index R9 Total irradiance Ee at maximum intensity Troubleshooting Switch on again Contact manufacturer service Check mains voltage check all connections Environmental conditions for transport storage and operation Ambient temperature Storage and transport Ambient temperature operation Relative humidity non condensing Weight CLED11FX PPS CLED11SX PPS Operating mode Operating mode Klassifizierung CLED11FX SX PPS Degree of protection as per IEC 529 According to standard 93 42 EWG Electrical safety test and EMC according to GMDN Code Service life of light source Service
5. 5 ft 0 74 m 2 43 ft 2 33 m 7 64 ft 7 37 m 24 18 ft 16 48 m 54 07 ft 23 3 m 76 44 ft Brandon MEDICAL BRILLIANT BY DESIGN Brandon Medical Co Ltd Elmfield Road Morley Leeds LS27 QEL Telephone 44 0 113 27 77393 Fax 44 0 113 27 28844 http www brandon medical com e mail enquiries brandon medical com These installation and operating instructions are for customer information only and will only be updated or replace upon request by the customer Brandon Medical Co Ltd D80 021 000 04 2014 Index 1 1 Subject to modification printed in Switzerland CE
6. NING rtn e a a deco eateaniacs 4 6 SAPET VANS EG TON eiin a a a a a a a ce etee idea geeteate 5 7 DEMOUNTING ceina A S 5 7 1 LIS OOS ell aires att cesses a a a a dees 5 8 ACCESSORIE Oparien ae Ea A bs 5 9 ADDITIONAHINSTRUCTIONS iseina a a 5 10 TROUBLESHOOTING aisar a a a e E 6 11 TECHNICALIDA TA conrra a A E O 6 12 ELEC TROMAGNETIG COMPATIBILIT Y EMG reises a a a tale a eral aT 7 1 SAFETY INSTRUCTIONS 1 1 Intended use The luminaire CLED11 is an examination luminaire Its intended use is to illuminate the body of the patient to support diagnosis or treatment An interruption of the diagnosis or treatment caused by a light failure is always possible without a risk for the patient The luminaire can not be used in operating rooms 1 2 User profiles Medical professional A medical professional is any person who has completed medical training and is working in his or her professional field Cleaning professional A cleaning professional is trained in national and job related hygiene regulations Electrician An electrician is trained in the fields of electronics and electrical engineering and is familiar with the relevant standards and regulations Qualified professional A qualified professional is capable of mounting and dismounting the luminaire thanks to professional training knowledge and experience and knowledge of the regulations 1 3 Safety instructions gt Operation by a medical professional gt The instruct
7. The quality of the mains power supply should match that of a typical business or hospital environment In proximity of this medical device do not operate devices with unusually strong network frequency magnetic fields transformer stations etc The supply voltage quality should be that of a typical business or hospital environment If the user requires continued function during any interruption of the energy supply system we recommend that the medical device be powered by an uninterrupted power supply or a battery Recommended minimum distance of portable and mobile radio devices of PEIRP radiated power to the medical device including its cables d 1 17VP Recommended minimum distance of portable and mobile radio devices of PEIRP radiated power to the medical device including its cables 80MHz 800MHz d 1 17VP 800MHz 2 5GHz d 2 33VP d recommended safe distance m P Rated Power of the sender W Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with o Recommended safe distances from portable and mobile HF communications equipment Rated Power of the sender W 150 kHz 800 MHz 0 12 m 0 39 ft 0 37 m 1 21 ft 1 17 m 3 84 ft 3 7 m 12 14 ft 8 27 m 27 13 ft 11 7 m 38 39 ft 0 01 0 1 10 50 100 800 MHz 2 5 GHz 0 23 m 0 7
8. ical device is intended for operation in an electromagnetic environment such as the one specified below The user must ensure that it is operated in such an environment Interference resistance to IEC 60601 1 2 testing Conformity level of the Electromagnetic environment level medical device Electrostatic discharge ESD Contact discharge 6 kV Floors made of timber concrete or ceramics tiles IEC 61000 4 2 Air discharge 8 kV are preferred Where synthetic floor covering is used the relative humidity should be at least 30 The quality of the mains power supply should High frequency emissions Class B Fast transients Power supply cables 2 2kV electrical disturbance kV variables Longer input and bursts IEC 61000 4 4 output cables 1 kV Surge voltages surges 1 kV phase to phase IEC 61000 4 5 voltage 2 kV phase to earth voltage Magnetic field in the power supply frequency 50 60 Hz IEC 61000 4 8 Voltage dips and short interruptions to the power voltage IEC 61000 4 1 1 Cut gt 95 0 5 periods Cut 60 5 periods Cut 30 25 periods Cut gt 95 5 seconds 3 V m 80 MHz 2 5 GHz Radiated HF disturbance variable IEC 61000 4 3 Conducted HF disturbance values IEC 61000 4 6 3 Vims value 150 kHz 80 MHz Not applicable Cut gt 95 0 5 periods Cut 60 5 periods Cut 30 25 periods Cut gt 95 5 seconds N mis value match that of a typical business or hospital environment
9. ions form part of the product They must be stored and made accessible to all subsequent users gt Any work on the luminaire including repairs must be carried out by qualified electricians only Mounting must be performed by a qualified professional only vvv Yy v M The luminaire must not be altered or manipulated in any way Only approved original parts must be used Any use other than the intended use with original parts may give rise to other technical values and life threatening danger Operation in potentially explosive areas is prohibited The luminaire power supply is a potential ignition source The luminaire must only be operated in dry dust free rooms The luminaire must not be left switched on without supervision Do not use any luminaire that is damaged Defective cables are also potential hazards Do not place the cable close to any heat source or on sharp edges Damage to the eyes Never look directly into the light source Replace any glass that is damaged before operating the luminaire again Never place additional loads on the luminaire head or the arm The luminaire must not be covered by a cloth or any similar item while it is in operation The ventilation openings where they exist must be free whenever the luminaire is in operation The luminaire must not be operated near to external heat sources that exceed the maximum ambient temperature of the luminaire The luminaire must not be used in envi
10. ronmental conditions other than those for which it is intended The luminaire must only be used for the intended use described in this document The manufacturer cannot be held responsible for any injury or damage that is caused as a result of any use other than the intended use or of any failure to comply with safety instructions and warnings Its recommended to protect the luminaire with an additional earth leakage circuit breaker 1 4 Warning levels Indication of hazards that can lead to death or serious injury if measures are disregarded Indication of hazards that can lead to injury if measures are disregarded CAUTION Indication of hazards that can lead to damage to property if measures are disregarded 2 SCOPE OF SUPPLY 2 1 CLED11FX PPS The following are included in the scope of supply 1x Luminaire 1x Power cable 2 2 CLED11SX PPS The following are included in the scope of supply 1x Luminaire 1x Power cable 3 MOUNTING gt The luminaires are equipped with an adapter pin The luminaire must be positioned in one of the accessories described in chapter 8 4 OPERATION Electric shocks are life threatening Do not insert any power cable that is damaged If there is any sign of damage to the power cable replace it immediately with a new one The supply voltage and frequency must match the data on the type plate Risk of eye damage gt Never look directly into the beam of light T
11. sree z F gt gt _ gt E TRT af be Phe D D he ET Kee t es pe On ee Put hte gt Ta e z am P D b ay A Sn Pod Mn IA amp N tys De A ed Ana Pu gt a A d v gt Insert power cable to the luminaire gt Connect the power cable with the power supply gt Switch the luminaire on off 5 DISINFECTION CLEANING Electric shocks are life threatening gt Remove the connector from the power supply and put the switch in the OFF position before the disinfection celaning CAUTION Damage to property caused by incorrect cleaning No cleaning agents containing alcohol solvents chlorine or abrasive products must be used Those agents can cause damages in the plastic parts The cleaning and disinfection agents must be Suitable and approved for plastics like PC PMMA PA and ABS Concentrated disinfectants may damage the cover Pay attention to the specifications from the data sheet of the agent for concentration and residence time Unsuitable cloths can cause scratches Dirt decreases luminosity gt Clean regularly to keep the cover clean gt Disinfection only by wiping is permitted gt Clean the PMMA cover with a suitable cleaning cloth and a suitable cleaning agent CAUTION To minimize the risk of disease transmission in addition to complying with this user manual you must also comply with the applicable occupational health and safety
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