curing light built-in c user`s manual
Contents
1. E E E E E E E E N 1041 2008 N ISO 14971 2009 N ISO 7405 2008 N ISO 17664 2004 N ISO 17665 1 2006 N ISO 10993 1 2009 N ISO 10993 5 2009 N ISO 10993 10 2010 19 2 EMC Declaration of conformity Guidance and manufacturer s declaration electromagnetic emissions The model BUILT IN C is intended for use in the electromagnetic environment specified below The customer or the user of the model BUILT IN C should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions The model BUILT IN C uses RF energy only for its internal CISPR 11 Group 1 function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The model BUILT IN C is suitable for used in domestic CISPR11 1 Hamonic emission establishment and in establishment directly connected to a low Ec Hop P Class A voltage power supply network which supplies buildings used for Voltage fluctuations flicker emissions IEC 61000 3 3 Not applicable domestic purposes Guidance amp Declaration electromagnetic immunity The model BUILT IN C is intended for use in the electromagnetic environment specified below The customer or the user of the model BUILT IN C should assure that It is used in such an environment Immunity test IEC 60601 test level Compliance level2. Electromagnetic environment guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile If floors are covered discharge ESD IEC patie 2 8 kV air 8 KV air with synthetic material the relative E humidity should be at least 30 Electrical fast 2kV for power supply Mains power quality should be that lines 2kV for power of a typical commercial or hospital transientiburst supply lines environment IEC 61000 4 4 1 kV for Input output lines Surge 1 kV line to line 42 kV line to Mains power quality should be that earth of a typical commercial or hospital IEC 61000 4 5 2 kV line to earth environment Voltage dips short 5 Ur Mains power quality should be that interruptions and lt 5 Ur gt 95 dip in of a typical commercial or hospital voltage variations on gt 95 dip in Ur Ur environment If the user of the power supply input for 0 5 cycle for 0 5 cycle model BUILT IN C requires lines 40 Ur 40 Ur continued operation during power IEC 61000 4 11 60 dip in Ur 60 dip in Uz mains interruptions it is for 5 cycles for 5 cycles recommended that the model 70 Ur 70 Ur BUILT IN C be powered from an 30 dip in Uz for 25 cycles 30 dip in Ur for 25 cycles uninterruptible power supply or a battery lt 5 Ur lt 5 Ur gt 95 dip in U7 gt 95 dip in for 5 sec Ur for 5 sec Power frequency magnetic fields pied ne should
3. Guilin Guangxi 541004 P R China Tel Europe Sales Dept 86 773 5873196 86 773 2125222 North America South America amp Oceania Sales Dept 86 773 5873198 86 773 2125123 Asia amp Africa Sales Dept 86 773 5855350 86 773 2125896 Fax 86 773 5822450 E mail woodpecker mailgl cn sales glwoodpecker cn Website http www glwoodpecker com Wellkang Ltd www CE Marking eu 29 Harley St LONDON W1G 9QR UK ZMN WI 04 560 2 3 Edition
4. be at levels characteristic of magnetic field 3 Alm 3 Alm a typical location in a typical commercial or hospital IEC 61000 4 8 environment NOTE Uz is the a c mains voltage prior to application of the test level 11 Guidance amp Declaration Electromagnetic immunity The model BUILT IN C is intended for use in the electromagnetic environment specified below The customer or the user of the model BUILT IN C should assure that it is used in such an environment IEC 60601 test Compliance Immunity test y level level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the model BUILT IN C including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms a 71 IEC 61000 4 6 150 kHz to 80 MHz 3V Clee Radiated RF 3 V m 1 2 IEC 61000 4 3 B0 MHz to 2 5 GHz 3 ORARE 200 MEETS 00 Ml d 2 3xP 800 MHz to 2 5 GHz 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 should be less than the compliance level in each frequency range Interference may occur In the vicinity of equipme
5. including ultrasonic pizeo scaler curing light micro motor apex locator and ultrasurgery etc 2 Principle and usage 2 1 BUILT IN C adopts the principle of ray radiation to solidify the light sensitive resin by shooting at it in a short time 2 2 This product is used to restore teeth and solidify material for whitening teeth 3 Structure and components BUILT IN C is composed mainly of high power LED optical fiber main unit 4 Technical specifications 4 1 Power supply 24V 50 60Hz 4 2 Rated current 0 3A 4 3 Applied part optical fiber 4 4 Lightsource 4 4 1 Blue light 4 4 2 Wave length 420nm 480nm 4 4 3 Light intensity 850mW cm 1000mW cm 4 5 Working condition 4 5 1 Environment temperature 5 C to 40 C 4 5 2 Relative humidity lt 80 4 6 Dimensions 23mm 250mm 4 7 Net weight 160g 4 8 Consumption power lt 8W 4 9 Protection type against electrical shock class II 4 10 Protection against electrical shock type B 4 11 Protection against harmful ingress of water or particular matter Ordinary equipment IPXO 4 12 Safety in the presence of flammable anesthetic mixture with air oxygen or nitrous oxide not suitable under this condition 4 13 Applied part optical fiber Notice the equipment needs to be installed in the medical power supply and to ensure that the final product meets the requirements of IEC 60601 1 5 Assembly and disassembly 5 1 Connect the power line which marked with 24V to the dental
6. unit 24V output lace the nylon thread to the dental unit it s ready to be operated Caution when assembling the power of the dental unit should be cut off The power line in the cable should be longer than the nylon thread in case break the power line when operating Optical fiber Light hood Digital screen On Off button Time button Full mode Ramping mode Pulse mode Mode switch 3 Cable 24V Input picture 1 5 2 Take off the red cap from the optical fiber and then insert the metal part into the front of BUILT IN C revolving make sure to screw the fiber to the end 5 3 To install the light hood on as show in picture 1 5 4 Uninstall the LED just reverse the procedure above 6 Operation 6 1 Press the time button to choose the solidification time 4 working time modes are available 5 10 15 20 seconds 6 2 Lightly press the mode key Following three modes are available 6 2 1 Full power mode blue light shine in full power 6 2 2 Ramping mode The power of the blue light turns from weak to stronger and reaches the highest power in 5 seconds 6 2 3 Pulse mode blue light work in the mode of pulse 6 3 During the operation aim blue light at the position needing solidification The machine will gives off a sound di when it is on It is strong blue light after 2 seconds with week blue light Then it counts down to 0 second to end the solidification 6 4 After the operation please
7. WOODPECKER CURING LIGHT BUILT IN C USER S MANUAL LY e Please read this manual before operating tog b Certified Management z System TOveheiniand EN ISO 9001 2 S ENISO 13485 N 0000033 GUILIN WOODPECKER MEDICAL INSTRUMENT CO LTD www glwoodpecker com Content T Installation ttc a Ptr cipe 1 2 Principle and usage iussus ette 1 3 Structure and components sese 1 4 Technical specifications sssssse 1 5 Assembly and disassembly sss 2 6 Operation eiie b e RE EUR ds 4 T CCAWUOTIS 35 eienen E ceteri pt egent oan acess 5 8 Contramdications siisii irinen piiriin 5 9 Maintenalic erret ia Hae e OR EH E PES EES 5 I0 After ServiC6 i oieniain eei NE E ERE 6 11 Trouble shooting ssseeeee 6 12 Storage and transportation sssssssees 6 13 Environmental protection 7 14 Packing list iiie he ERE RS 7 15 Manufacturer s right esse 7 16 For technical data please contact suse 8 17 Symbol instruction sss 8 18 Statements si aste nu veseiniini bino 9 19 Declaration of conformity ssssssessss 10 1 Installation Guilin Woodpecker Medical Instrument Co Ltd is a high tech enterprise in researching developing and producing dental equipment and has a perfect quality assurance system main products
8. act Wellkang Ltd www CE Marking eu 29 Harley St LONDON W1 G 9QR UK 17 Symbol instruction gem Trademark C CE marked product e iN Type B applied part FLA FDA marked product IPXO Ordinary equipment Date of manufacture Class II equipment t n Alternating current oy Manufacturer is e Recovery 1 Used indoor only Keep dry a Screw inside outside Handle with care a L els r 55 C D ape X Temperature limitation 80 Humidity limitation 0 106 Atmospheric pressure for storage Appliance compliance WEEE directive n ee Consult the accompanying documents Authorised Representative in the EUROPEAN COMMUNITY cennedvnsgenee Got the quality management system certification stem EN ISO 3001 ymo and CE certification issued by T V Rheinland 7o 00003 18 Statement All rights of modifying the product are reserved to the manufacturer without further notice The pictures are only for reference The final interpretation rights belong to GUILIN WOODPECKER MEDICAL INSTRUMENT CO LTD The industrial design inner structure etc have claimed for several patents by WOODPECKER any copy or fake product must take legal responsibilities 19 Declaration of conformity 19 1 Product conforms to the following standards N 60601 1 2006 N 60601 1 2 2007 N 61000 3 2 2006 N 61000 3 3 2008 N 60601 1 4 1996 N 60825 1 2007 N 980 2008 ISO 9687 1993 tj tmr m t tm y
9. ber insufficient cracked 3 Wipe off the resin 3 There is resin remained on the surface of optical fiber If any malfunction case was found please contact with the dealer the unit was purchased or our company 12 Storage and transportation 12 1 This equipment should be handled carefully kept away from shaking point installed or stored at shadowy dry cool and ventilated places 12 2 Don t store it together with articles that are combustible poisonous caustic and explosive 12 3 This equipment should be stored in the environment where the relative humidity is lt 80 the atmosphere pressure is 70kPa to 106kPa and the temperature is 10 C to 55 C 12 4 Excess impact or shake should be avoided during transportation 12 5 Don t mix it with dangerous articles during transportation 12 6 Keep it away from sun or snow or rain during transportation 13 Environmental protection There is not any harmful element in this equipment It can be disposed of according to the local laws 14 Packing list The components of the epuipment are listed in the packing list 15 Manufacturer s right We reserve the rights to change the design of the equipment the technique fittings the instruction manual and the content of the original packing list at any time without notice If there are some differences between blueprint and real equipment take the real equipment as the norm 16 For technical data please cont
10. clean the fiber with calico in order not to affect the light intensity 6 5 The depth of solidification of composite is no less than 4mm per 10 seconds 6 6 The optical fiber can be spinned off by 360 and autoclaved to 135 C and 0 22MPa 7 Cautions 7 1 When in clinical operation make sure the light source be aimed at the resin directly improperty position will affect the solidification 7 2 Avoid aiming at eyes directly WARNING If the curing light works for 40s continously the temperature of the top of optical fiber may reach 56 C WARNING Do not modify this equipment without authorization of the manufacturer 8 Contraindications Heart disease patients pregnant women and children should be cautious to use this equipment 9 Maintenance 9 1 Only the optical fiber can be autoclaved under high temperature and pressure other parts should be waped by clean water or disinfectants if necessary never immersed 9 2 After operation each time clean the optical fiber 10 After service Two year warranty according to the warranty card 11 Trouble shooting 1 The main unit doesn t l Check with the on indication connect well with the connection of the main unit on act nit or the power doesn t and the unit 2 Make sure the power is on 1 The optical fiber is not 1 Insert the optical fiber inserted till the botton again correctly Light intensity 2 The optical fiber has 2 Change the optical fi
11. nt marked with the following symbol aD NOTE At 80 MHz end 800 MHz 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 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 model BUILT IN C is used exceeds the applicable RF compliance level above the model BUILT IN C should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the model BUILT IN C Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3V m 12 Recommended separation distances between portable and mobile RF communications equipment and the model BUILT IN C The model BUILT IN C is intended for use in electromagnetic environment in which radiated RF disturbances is controlled The customer or the user of the model BUILT IN C can help prevent electromagnetic interference by maintaining a minimum distance between por
12. table and mobile RF communications equipment transmitters and the model BUILT IN C as recommended below according to the maximum output power of the communications equipment Rated maximum output Separation distance eecorng to frequency of transmitter power of transmitter 150kHz to 80MHz poete 800MHz to 2 5GHz w d 1 2xP det 2xpi d 2 3xP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 12 23 10 3 8 3 8 73 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W accordable to the transmitter manufacturer NOTE At 80 MHz and 800 MHz the separation distance for 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 The device has been tested and homologated in accordance with EN 60601 1 2 for EMC This does not guarantee in any way that this device will not be effected by electromagnetic interference Avoid using the device in high electromagnetic environment 13 Scan and Login website for more information psa Guilin Woodpecker Medical Instrument Co Ltd tal Information Industrial Park National High Tech Zone
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