USER MANUAL
Contents
1. Compliant with international standards 60601 1 IEC 601 2 18 IEC 60417 and DIN EN 980 e Class Laser risk group 2 12 011364B 02 2012 ELECTROMAGNETIC COMPATIBILITY 11 1 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS The device is intended for use in the electromagnetic environment specified below The user should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissi This device uses RF energy only for its internal function Therefore its emissions aie y CISPR 11 Group 1 RF emissions are very low and are not likely to cause any interference in nearby electronic eguipment RF emissions CISPR 11 ane This device is suitable for use in all establishments and those directly connected to the public low voltage network that Harmonic emissions supplies buildings used for domestic purposes IEC 61000 3 2 Classa Voltage fluctuations Flicker Compliant IEC 61000 3 3 011364B 02 2012 13 11 2 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY This device is intended for use in the electromagnetic environment specified below The user should assure that it is used in such an environment IEC 60601 Compliance Immunity test Electromagnetic environment guidance Test level level Electrostatic discharge ESD 6 kV dans contact 6 kV Floors should be2. led USER MANUAL SOPRO X USER MANUAL ENGLIS CONTENT O INTRODUCTION dedito 3 O DESCRIPTION OF LIGHT SOURCE 3 O SAFETY INSTRUCTIONS 4 REGULATIONS atan ni 6 4 1 CONFORMITY 4 2 ELECTROMAGNETIC INTERFERENCE AND ELECTROSTATIC DISCHARGE 4 3 MEDICAL DEVICE VIGILANCE 4 4 DISPOSAL INSTALLATION cosas cir e i e 7 5 1 POWER SUPPLY CONNECTION 5 2 CONNECTION OF LIGHT CABLE USER SETTINGS a 8 6 1 SWITCHING ON 6 2 ADJUSTING THE LIGHT INTENSITY 6 3 POWER LEVEL MEMORY TU o o 9 7 1 DESCRIPTION OF FANS 7 2 MAINS TRANSFORMER PLUG 7 3 SPECIFICATIONS AND SYMBOLS ON THE PRODUCT RECOMMENDED DECONTAMINATION PROCEDURE 10 CUSTOMER SERVICE amp MAINTENANCE 11 9 1 THE INDICATOR LIGHT L DOES NOT GO ON AFTER THE DEVICE HAS BEEN SWITCHED ON 9 2 THE LIGHT GOES ON BUT THE LUMINOUS POWER IS POOR 9 3 THE DELIVERED IMAGES ARE TOO BRIGHT OR SATURATED 9 4 THERE IS NO LIGHT BUT THE FANS CONTINUE TO OPERATE 9 5 THE LIGHT ALTERNATELY SWITCHES ON AND OFF 9 6 THE INDICATOR LIGHT ILLUMINATES BLUE 10 TECHNICAL CHARACTERISTICS 12 Q ELECTROMAGNETIC COMPATIBILITY 13 011364B 02 2012 O INTRODUCTION We would like to thank you for the confidence you showed
3. such as compressors motors transformers HF generators etc 4 3 MEDICAL DEVICES VIGILANCE Like all medical products this device is subject to the Medical Devices Vigilance regulations Therefore any serious malfunction must be immediately notified to the relevant authorities and the manufacturer as detailed as possible For manufacturer contact details see last page of manual 4 4 DISPOSAL This device is marked with the recycling symbol pursuant to EU directive 2002 96 EC on waste electrical and electronic eguipment WEEE By correctly disposing of this device you avoid potential damage to the environment or human health The symbol on the device or on the documents supplied means that the device must not be treated as household waste It must be deposited at a designated collection facility which is dedicated to the recycling of waste electrical and electronic eguipment In addition all local regulations regarding disposal applicable in the country in which you work must be observed For more information on treatment recovery and recycling of the device please contact your nearest distributor who will instruct you on the procedure to be followed 6 011364B 02 2012 INSTALLATION Place the device on a stable surface and connect the different accessories which are reguired for operation If using a cabinet ensure sufficient ventilation at all sides min 15 cm around the device 5 1 POWER SUPPLY CONNECTION e Select the s
4. to operate the device with a defective power cord v To disconnect the cable from the power supply always pull the plug never the cable itself v Disconnect the device from the power supply if you intend not to use it for several days or a longer period v Do not place the light source on textile surfaces carpet blankets etc v This light source is exclusively intended for use with the endoscopes recommended in chapter 2 v If other cables or accessories are used than the ones specified this may result in an increase emissions or a decrease of the noise immunity of the device v The fans must not be covered D 4 011364B 02 2012 Y Ensure sufficient ventilation in order to avoid overheating inside the device at least 15cm at all sides of the device Do not cover the device and ensure that the legs of the device are always visible v Never place the device near a heat source or in a location where it is exposed to vibration and or shock v Never use corrosive or abrasive products to clean the device but only the disinfectant agents as recommended in chapter Cleaning Y This device is not suitable for use in an ionizing environment v Do not expose the device to laser radiation v The device is not sterile v Before every use check the device for rough surfaces sharp edges or protruding elements which could present a safety risk Y When removing the fibre from its light guide after use of the lamp the temperature of the
5. wood concrete or ceramic tile If floors are covered EN 61000 4 2 8 KV dans air 8 kV with synthetic material the relative humidity should be at least 30 Electrical fast 2 kV pour les lignes dana d alimentations 12 kV Mains power quality should be that of a typical commercial or transient burst i 1 kV pour les lignes 1kV hospital environment EN 61000 4 4 d entr e sortie Surge Mains power quality should that of a typical commercial or EN 61000 4 5 Moagidirferentiet i KV hospital environment Voltage dips short interruptions lt 5 UT for 10 ms lt 5 UT 10 ms Mains power quality should be that of a typical commercial or and voltage variations on power 40 UT for 100 ms lt 40 UT 100 ms hospital environment If the user of the device requires continued supply input lines 70 UT for 500 ms lt 70 UT 500 ms operation during power mains interruptions it is recommended that EN 61000 4 11 lt 5 UT for5 s lt 5 UT5s the device be powered from an inverter or a battery Power freguency Power freguency magnetic fields should be at levels characteristic 50 60 Hz 3 A m 3 A m of a typical location in a typical commercial or hospital magnetic field environment Portable and mobile RF communications eguipment should be used no closer to any part of the device including cables than the recommended separation distance calculated from the eguation applicable to the freguency of the transmitte
6. HT ALTERNATELY SWITCHES ON AND OFF Check if the light cable has been connected correctly 9 6 THE INDICATOR LIGHT ILLUMINATES CYAN The light source is in temperature protection mode check if the temperature range specified in the present manual is observed 011364B 02 2012 11 TECHNICAL SPECIFICATIONS Main functions LED technology e Power rating 30W the light intensity corresponds to a 100 watt Xenon lamp e Colour temperature gt 4500 K e Typical LED life span 50 000 hours under normal conditions of use Compatible light cable Storz only Electronic aperture e Adjustment of light intensity manual Anti blinding system with light cable sensor e Automatic overheat protection system Power level memory Supply voltage of the transformer 100 240VAC 50 60Hz Transformer 12VDC Power consumption 30VA e Dimensions L 180mm D 95mm H 35mm Weight 3209 e Continuous service Environment Operating temperature 10 C 40 C e Operating humidity 30 to 75 e Transport and storage temperature 10 C 45 C e Humidity during transport and storage 20 to 85 e Atmospheric pressure during operation transport and storage 700hPa to 1 060hPa Not splash proof IPXO e Not suitable for use with mixtures of flammable anaesthetics with air and oxygen or nitrous oxide Regulatiory Electrical safety class 2 type BF 5 Compliant with EU directive 93 42 EEC class 1
7. Light cable 4 5mm L 2 5m power supply connector Storz only Endoscopes with diameter 1 9 2 7 3 4 8 5mm 011364B 02 2012 3 SAFETY INSTRUCTIONS v Read the user manual carefully v Observe the conditions of use and storage v Before connecting the light source to the mains supply check if the parameters of your power circuit match the specifications on the device Information regarding the electric voltage the consumption etc can be found on the power supply unit v Never look directly in the light source or the end of the light cable v Do not submit the device to excessive dust exposure v The device should only be opened by a qualified technician authorized by the manufacturer v Do not insert any other objects than the light cable in the socket B as otherwise damage to the optical system may result Do not insert metallic objects in the device as this may result in risk of electric shock fire short circuit or hazardous emission v Do not expose the device to splash water or use in an environment with excessive humidity v Do only use the accessories supplied with the device or recommended by the manufacturer as an option v The device is not explosion proof Therefore never use it together with flammable anaesthetics v Do not place heavy objects on the device v If the power cord or the transformer are damaged immediately isolate the light source from the electric circuit It is extremely dangerous
8. be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the device b Above the freguency range 150kHz to 80MHz field strengths should be less than 10 V m 14 011364B 02 2012 ENGLISH 11 3 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE DEVICE This device is intended for use in an environment in which radiated RF disturbances are controlled The user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the device as recommended below according to the maximum output power of the communications equipment Separation distance ai to frequency of transmitter Rated PEE i ST 150KHzto80MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 16VP d 1 16VP d 233VP 0 01 0 116 0 116 0 233 0 1 0 366 0 366 0 736 1 1 16 1 16 2 33 10 3 66 3 66 7 36 100 11 6 11 6 23 3 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be determined using the eguation 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 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range app
9. ected properly to the mains supply 9 2 THE LIGHT GOES ON BUT THE LUMINOUS POWER IS POOR Check if the reguirements of chapter 6 User settings are met Check the condition of the light cable and your optical system 9 3 THE DELIVERED IMAGES ARE TOO BRIGHT OR SATURATED Check if the light intensity is set too high Check the camera settings 9 4 THERE IS NO LIGHT BUT THE FANS CONTINUE TO OPERATE light cable is disconnected e The light source has an integrated safety device which automatically switches off the light in case of excessive internal temperature of the device After the temperature decreased the lamp can be used again Ensure that there is sufficient space around the device for adeguate cooling minimum 15cm at all sides of the device Ensure that the ventilation slots at the rear and the bottom of the source are not covered If the fault persists and you need to return the device to customer service please return the device in its original packaging after disinfecting it AN The product must be disinfected before returning it for repair When returning a product check its condition and inform the carrier of any comments to be recorded on the delivery note by registered letter within 48 hours If goods shipped by us are damaged during transport the repair amount will be either charged to the carrier if the comments were made in a timely manner or otherwise they will be charged to the receiver 9 5 THE LIG
10. ight source is a medical product which is not heat resistant and must not be immersed in liguid Conseguently disinfection is made using a non woven fabric cloth to which a disinfecting agent is applied A The disinfecting agent can be chosen from the category F in the list of admitted disinfectants by the French Society of Hospital Hygiene A The cleaning depends on the selected products methods and or tools and is thus the sole responsibility of the involved personnel AN The disinfection procedures indicated for this type of material indicate that disinfection is made with either one or the other of these two solutions for the entire life cycle of the product AN the device is not autoclavable A Alkaline solutions available for disinfection of certain medical products are NOT allowed for disinfection of this device A The procedures described in this chapter are to be understood as guidelines only and can in no event replace official recommendations or directives 011364B 02 2012 CUSTOMER SERVICE MAINTENANCE Make sure that the fans D are not obstructed by dust If this is the case isolate the device from the mains supply and vacuum the dust In case of incidents please contact our customer service or our nearest distributor We remind you that faults due to incorrect use are not covered by the guarantee 9 1 THE INDICATOR LIGHT L DOES NOT GO ON AFTER THE DEVICE HAS BEEN SWITCHED ON Check if the mains transformer is conn
11. in us by purchasing this device Please read this manual carefully in order to fully benefit from the device while complying with all necessary precautions Sentences marked with this symbol A require particular attention Sentences marked with this symbol i contain useful information In order to facilitate the installation and utilisation of this device we intended to make this manual more practical Therefore throughout the manual you will find references to the image page on the back of the cover e g in form of D1 which will help you to identify the corresponding parts of the product O DESCRIPTION OF LIGHT SOURCE This 30 Watt LED light source has been especially designed for endoscopic diagnosis applications in medical practices of the following special fields ent gynecology urology veterinary It is equipped with an electronic iris with fibre optic sensor an automatic thermal protection system and a power level memory Its ease of use its illuminating power and a precise manual light intensity regulation make it an ideal medical device for multiple disciplines It comprises the light source itself the power adapter 12V transformer including a set of international plugs e the user manual ZN In order to ensure conformity of the product please only use the supplied transformer This equipment was supplied to you in a cardboard packaging which you should keep for potential transport Recommended accessories e
12. lies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 011364B 02 2012 ANNEXE 1 SYMBOLS SYMBOLES PICTOGRAMAS SIMBOLI BILDZEICHEN Manufacturing date Date de fabrication Fecha de fabricacion Data di produzione Herstellung datum Manufacturer Fabricant Fabrica Produzione Hersteller Comply with the European Directive 93 42 CEE Conforme la directive europ enne 93 42 42 CEE Conforme a la directiva europea 93 42 CEE Conforme alla direttiva europea 93 42 CEE Entspricht des Europ ischen Weisung 93 42 CEE Read the User Manual Lire le manuel d utilisation Observe la documentacion adjunta Leggere la documentazione allegata Begleitpapiere beachten Dispositif de type BF Type BF device Apparecchio mod BF Aparato del tipo BF Ger t des Typs BF UK Disposal of electric and electronic equipment marketed after 13 August 2005 This symbol indicates that the product cannot be treated with domestic waste Appareil de classe Il Class Il device Apparecchio di classe II Aparato del classe Il Ger t des Klasse Il ZAC Ath lia IV Avenue des Gen vriers 13705 la Ciotat cedex FRANCE T l 33 0 442 98 01 01 Fax 33 0 442 71 76 90 Email info soprocomeg com Web www soproccomeg com Non contractual document Ref 011364B 02 2012 Copyright O 2010 SOPRO COMEG A
13. ll rights reserved No information or part of this document may be reproduced or transmitted in any form without the prior permission of SOPRO COMEG
14. metal coupler is very high and injuries may occur when touching v The luminous power at the outlet of the cable can cause damage to the eye Be careful when handling the light cable when the lamp is operating at full power Y Never touch the patient or other flammable material bed sheets dressings surgical drapes directly with the end of the light cable or the endoscope as it can become very hot risk of burning A Class Laser risk group 2 Caution Possibly hazardous optical radiation emitted from this product Do not stare at operating lemp may be harmful to the eyes 011364B 02 2012 5 REGULATIONS 4 1 CONFORMITY This product was designed and manufactured by a company which has a certified guality system in place It complies with the reguirements of EU directive 93 42 EEC on medical products It therefore also complies with the electrical safety standards IEC and the applicable standards for electromagnetic compatibility EMC 4 2 ELECTROMAGNETIC INTERFERENCE AND ELECTROSTATIC DISCHARGE Despite compliance with the EMC standards it may occur under certain circumstances that the device interferes with other devices or is subjected to interferences by other devices and or in an electromagnetic environment In order to avoid such incidents we recommend the following e Ensure the quality of the electric supply especially grounding of all devices and tables trolleys Keep the device away from electromagnetic sources
15. r Recommended separation distance d 1 1606 Conducted RF 3Vrms 3V d 1 16VP to 800MHz EN 61000 4 6 150kHz to 80MHz d 2 33VP 800 to 2 5GHz Radiated RF 3V m EN 61000 4 3 80MHz to 2 5GHz 3V m 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 meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE UTisthe nominal value of the supply voltage applied during the testing NOTE 1 At 80MHz and 800MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio 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 device is used exceeds the applicable RF compliance level above the device should
16. uitable connector at the power adapter AN Only use the wall mounted transformer supplied FRIWO type FW 7362M 12 Connect the power cable to the light source A Connect the power adapter to the mains supply 5 2 CONNECTION OF LIGHT CABLE A Do not attempt to unscrew or pull the round connector at the front of the device e As a standard the light source is equipped with a fixed adapter for the Storz type light cable which cannot be replaced Insert the cable in the intended opening B you should hear a clicking noise indicating that the cable in locked Connect the other end of the light cable to your endoscope i Before connecting an endoscope or a fiberscope check the condition of the endoscope clean distal lens quality of optical fibres adjust if necessary 011364B 02 2012 USER SETTINGS 6 1 SWITCHING ON The LED source is eguipped with a switch at the top of the device C After switching on the device an automatic test of 3 seconds is performed to check all components Then the lamp switches in standby mode and the indicator light L flashes yellow 6 2 ADJUSTING THE LIGHT INTENSITY When switched on the device is started at its maximum power gt Connect a light cable to have luminous power gt Press the button C the luminous power is set to the maximum continuous blue light gt By pressing button C for a longer period the luminous power is decreased flashing blue to reach the lo
17. w intensity level continuous green light release gt From the low intensity level a long pressure on C will increase the luminous power flashing green until you reach the maximum power continuous blue light release gt Select then the reguired luminous power the LED may flash green or blue which indicates that a long pressure will respectively increase or decrease the luminous power 6 3 POWER LEVEL MEMORY To switch the LED in standby mode light and fans off simply press button C for a short time If pressed again the light will come back with the same luminous power as before satnad by mode except in case of power cut 8 011364B 02 2012 DESCRIPTION 7 4 DESCRIPTION OF FANS fans must not be covered in order to prevent overheating light source is equipped with an automatic safety device which stops the light intensity in case of excessive internal temperature 7 2 MAINS TRANSFORMER PLUG The power supply of the device is realised by means of a mains transformer supplied with the system 7 3 SPECIFICATIONS AND SYMBOLS ON THE PRODUCT The specifications and symbols at the bottom of the product allow identification of the camera complying with the international standards IEC 60601 1 IEC 60601 2 18 IEC 60417 and DIN EN 980 see annex 1 011364B 02 2012 9 RECOMMENDED DECONTAMINATION PROCEDURE A This procedure applies exclusively to the enclosure of the LED light source AN The LED l
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