Translux® Wave - Heraeus Kulzer
Contents
1. Exposure with slowly increasing output Soft Start cycle duration 20 seconds The Soft Start means increase of light intensity from 50 up to 100 within 2 seconds e Ifthe hand piece is in Sleep Mode all the curing mode LEDs on the hand piece are OFF briefly press the Start Stop butte W Briefly press the Start Stop button Ww The light emission will turn on The 10 second LED is on showing that this program is running Once the curing cycle is complete the unit will automatically turn the light off Acoustical signal The following acoustical signals beep are emitted 1 beep while press the Start Stop button 1 beep at the end of the exposure time Exposure 20 seconds Soft Start polymerisation Press and keep pressed for at least one second the Start Stop button Ww The light emission will turn on The 20 second LED is on showing that this program is running Once the curing cycle is complete the unit will automatically turn the light off and the unit returns to the 10 second mode 10 second LED on Acoustical signal The following acoustical signals beep are emitted 1 beep while press the Start Stop button 1 beep after 1 second for acoustic indication of Soft Start mode activation 1 beep after 10 seconds of exposure time 1 beep at the end of the exposure time ay NOTE The exposure cycle can be interrupted at any time before2. Soft Start cycle duration 20 seconds The Soft Start means increase of light intensity from 50 up to 100 within 2 seconds Re NOTE Observe the exposure times of the materials specified by the manufacturer 3 2 For materials with specific exposure times e g 30 40 seconds for dark composites repeat the exposure several times Necessary Safety requirements The effectiveness of the safety instructions with regard to personnel protection handling the unit and handling the processed prodi is to a large degree dependent on the behaviour of the staff working with the equipment WARNING 3 2 1 Prior to initial operation carefully read through these Operating Instructions and observe the information in order to avoid errors and subsequent damage particularly damage to health n addition to the instructions in this operating manual comply with the national laws regulations and directives in your country when setting up and operating the unit General safety instructions on operating the device WARNING INTENDED USE Use the unit only for the purpose for which it is intended see paragraph 3 Intended use Any other uses are strongly contra indicated Any non compliance of this regulation can result in serious injury of the patients or operators of the unit well as damage or faults to the unit Heraeus Kulzer is not liable for consequential damages due to the non observance o the aforementioned provisi
3. 3 C 270 F 5 F Max 500 cycles 10 seconds of exposure time Soft Start exposure Charging time of empty battery Environmental conditions of unit Weight and dimensions Acoustical signals 1 beep at the start of exposure 1 beep at the end of exposure 20 seconds of exposure time The Soft Start means increase of light inten from 50 up to 100 within 2 seconds Acoustical signals 1 beep at the start of exposure 1 beep after 1 second for indication of Soft Start mode activation 1 beep after 10 seconds of exposure 1 beep at the end of exposure Approx 3 hours Operation Transportation and storage Temperature 10 C 35 C 20 C 40 C 50 F 95 F 4 F 104 F Relative humidity 45 85 45 85 Atmospheric pressure 800 1060 hPa 500 1060 hPa Charging unit weight 450 g Dimensions L 140 x W 58 x H 62 mm Hand piece weight 150 g incl light guide Dimensions L 275 mm max 24 mm 12 1 Electromagnetic compatibility EN 60601 1 2 A N WARNING The device requires specific EMC precautions and must be installed and started up in accordance with the EMC information given in this paragraph Portable and mobile radio communication appliances may affect the correct function of the device Guidance and manufacturer s declaration Electromagnetic emissions The Translux Wave is intended for use in the electromagnetic environment specifi
4. Function It indicates the charging unit is powered up 10 7 2 colour LED GREEN YELLOW O Oo N gt Function Light intensity information GREEN Indicates that the light intensity measured with the built in light meter is suitable for effective treatment YELLOW Indicates that the light intensity is insufficient Bottom view charging unit 11 Power supply socket 12 Replaceable charging contact insert 4 2 4 Acoustical signals hand piece Function Error Condition Hand piece Button operation Acoustic signal s emitted Indications on the hand piece POLIMERISATION Press the START STOP e 1 beep when pressing the A tc PROGRAM 10 seconds Satan briefly to start the START STOP button e 1 beep at the end of exposure exposure imne The green LED 10 second light on SOFT START PROGRAM Press the START STOP 1 beep when pressing the A 1 20 seconds ation oraeson START STOP button 1 beep after 1 second for second to start the exposure acoustic indication of Soft Start mode activation 1 beep after 10 seconds of exposure time 1 beep at the end of exposure time The green LED 20 second light on INTERRUPTION OF THE The exposure cycle can be e 1 beep when pressing the EXPOSURE CYCLE interrupted at any time and START STOP button program in use by pressing the AN START STOP button Se BATTERY LOW SIGNAL e 2 beeps at the end of the expos
5. The device continues to work regularly and in 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 commercial or hospital environment Mains power quality should be that of a typical commercial or hospital Voltage dips short lt 5 Ur gt 95 dip in Ut The device can vary from Mains power quality should be that of a interruptions and for 0 5 cycle the required levels of typical commercial or hospital voltage variations 40 Ut 60 dip in Ur immunity with a duration environment on power supply for 5 cycle for as long as the device input lines IEC 70 Ur 30 dip in Ur remains in safety no 61000 4 11 for 25 cycle malfunctions have been lt 5 Ut gt 95 dip in Ut detected and can be for 5 sec restored to pre test status with the intervention of the operator Power frequency The device continues to Power frequency magnetic fields should 50 60 Hz work regularly and in be at levels characteristic of a typical magnetic field IEC safety location in a typical commercial or 61000 4 8 hospital environment NOTE Ur is the a c mains voltage prior to application of the test level Guidance and manufacturer s declaration Electromagnetic immunity The Translux Wave is intended for use in the electromagnetic environment specified below The customer or the user
6. of the Translux Wave should ensure that it is used in such an environment Immunity test IEC 60601 Compliance level Electromagnetic environment Guidance test level Conducted RF 3 Vef 150 kHz to The device Portable and mobile RF communications equipment IEC 61000 4 6 80 MHz continues to work should be used no closer to any part of the disposal regularly and in including cables than the recommended separation Radiated RF 3 V m 80 MHz to safety distance calculated from the equation applicable to the IEC 61000 4 3 2 5 GHz frequency of the transmitter Recommended separation distance d 1 2 vP d 1 2 VP 80 MHz to 800 MHz d 2 3 VP 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 metres 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 b Interference may occur in the vicinity of equipment marked with the following symbol i Notes 1 At 80 MHz and 800 MHz the higher frequency range applies 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 mo
7. a 1 oO w Z O bar m This arrow indicates the orientation with which the battery must be inserted into the hand piece D O lowly slide the battery with the arrow oriented toward the housing into the hand piece until it stops Fig 4 Z O wr m If the battery is inserted in the wrong way i e in the opposite direction of the arrow the hand piece will not function In case the battery is inserted in the wrong way no damage is caused to the hand piece s electronics WARNING D Use original Heraeus Kulzer batteries only The use of other manufacturer batteries or non rechargeable batteries primary batteries is a potential hazard and can cause irreversible damage to the unit 5 Use a flat tool for example a coin to screw clockwise the battery cap of the hand piece NOTE ul The unit will not function properly if the cap of the hand piece is not screwed on completely 5 4 Inserting the fibre optic into the hand piece Rotate the light guide slightly 1 and insert it into the hand piece 2 until final positioning is reached The final position is reached when you hear a click Mount the protective light cone 3 on the top end of the light guide gt Positioning the light guide Rotate the light guide into the desired position for the polymerisation To make full use of the light intensity provided place the light guide as close to the composite as possible Avoid direct c
8. Battery transportation and storage conditions Recommended temperature and relative humidity ranges 20 C 4 F to 40 C 104 F and 45 to 85 RH Always store the battery charged and not for longer than 5 months Ambient air pressure 500 hPa to 1060 hPa 13 NOTE Always fully charge the battery before an extended period of inactivity of the device and at least once every 5 montt In case of extended period of inactivity replace the battery trom the hand piece e Battery Typical Life Characteristics The Translux Wave battery has a typical life expectancy of 300 400 charging cycles depending on the application and environmental conditions in which it is used IB NOTE The battery is a chemical product utilising a chemical reaction so the performance will deteriorate not only through i but also with the passage of time even if it left unused 3 2 5 LIABILITY Work on electronic equipment in the unit must be carried out by Heraeus Kulzer Heraeus Kulzer service partners or qualified specialist personnel only and when the equipment is in a safe status de energised Only use authorised original spare parts and accessories Avoid other parts as they hide unknown risks The operability and safety of the unit is only guaranteed if the necessary tests maintenance and repair work is carried out by Heraeus Kulzer Heraeus Kulzer service partners or trained specialist personnel For possible damage coming from a fault
9. fold out front cover 17 17 17 17 18 18 19 19 19 20 22 23 25 25 25 26 26 26 Please fold out rear cover 1 Application 1 1 In general Translux Wave is a registered trademark of Heraeus Kulzer GmbH These operating instructions apply to 66055012 Translux Wave LED Light curing unit 2013 08 99000943 00 1 2 EC Declaration of Conformity We Heraeus Kulzer GmbH Gruner Weg 11 63450 Hanau hereby declare that the design structure and version introduced to the market of the unit described below correspond to the relevant safety and health requirements of the EU Directive This declaration shall become invalid in the event of an alteration made to the unit without our prior authorisation 1 3 Manufacturer s declaration We hereby confirm that the unit Translux Wave complies with the directive 93 42 EC and the standards IEC 60601 1 and IEC 606 1 2 Hanau 2013 08 Heraeus Kulzer GmbH Gruner Weg 11 63450 Hanau Germany 2 Instructions on using the unit safely Please read this manual and follow its instructions carefully The words WARNING CAUTION and NOTE carry special meanings and must be carefully reviewed see the following paragraph Always keep this manual within easy reach Explanation of symbols and accompanying word s Symbols Accompanying word s Explanation WARNING Implies that death or serious injury could occur if the advice is not followed CAUTION Impli
10. future use Connect the plug of the power cord into the socket on the underside of the charging unit WARNING Check the power cable the power supply unit and the adapter regularly to make sure that they are in good condition If damage is apparent do not use damaged part until it is replaced Use original Heraeus Kulzer spare parts and accessories only 8 Plug the power supply unit with its adapter into the mains power outlet The GREEN LED on the charger unit will light up icon 5 3 Inserting the battery into the hand piece The Translux Wave is supplied with a powerful Lithium ion rechargeable battery The battery is supplied separately in the device packaging and must be inserted into the hand piece before initial operation WARNING Carefully follow all the safety precautions described in the paragraph 3 2 3 BATTERY Safety precautions CAUTION NEVER place the hand piece in the charging unit without the battery inserted in the hand piece Insert the battery into the hand piece in the sequence described below 1 Remove the battery from its packaging WARNING Never short circuit the terminals of the battery with any metal object as it could cause a risk of burns fire and explosic Use a flat tool for example a coin to unscrew counter clockwise the battery cap of the hand piece Fig 1 and 2 gt 5 ed 3 O T 3 mi 14 Q O 5 r gt 14 oO ed MO lt O 2 14
11. horizonte surface oS IMPORTANT The hand piece is intended for use within the patient environment whereas the charger unit and the Switching Power Sup adapter are not intended for use within the patient environment 4 NOTE The patient environment is defined as an area 1 5 m from the patient as per IEC 60601 1 third edition and IEC 60601 1 WARNING Always inspect the unit and its components for any damage before installation If damage is apparent do not proceed with the installation of the device The operator must not come simultaneously into contact with the elements outside the patient environment charger units and switching power supply adapter and the patient Do not connect other external components to the medical system 5 1 Safety requirements during Installation WARNING The electrical installation of the premises where the device is installed and used must comply with existing legislation ana the safety specifications relevant to power systems Install the device in a place where it will be protected from blows and from accidental splashes of water or other liquids L not expose the device to direct sunlight UV light Do not install the device on top or close to sources of heat When installing make sure that there is adequate air circulati around the device Do not install the device close to solvents or flammable liquids as they could damage the plastic casin of the device The plug of the Switchi
12. malfunction of the unit due to improper repair which was not carried out by Heraeus Kulzer service partners or by personnel trained by us or in cases where original spare accessory parts were not used during a pa replacement Heraeus Kulzer GmbH is not liable 4 Unit description 4 1 Delivery contents Charging unit Hand piece Light guide 8 mm Protective light cone Rechargeable Lithium ion battery pack oa fF O N Universal input power supply 100 V 240 V including international mains socket adapters 6a Europe type 1 6b UK type 2 6c US JP type3 4 2 Description of the control and operating elements 4 2 1 Hand piece Transltux Wave Start Stop button Curing modes LEDs GREEN 3 Battery status LED 2 colour GREEN YELLOW 4 Charging unit contacts 5 Alignment key 4 2 2 Alignment key 4 2 2 The alignment key 5 located at the back bottom part of the hand piece s case allows the correct insertion of the hand piece in th charging unit holder When inserting the hand piece into the charging unit the alignment key must be aligned with the guiding slot positioned inside the charging unit A beep confirms that the contacts are in the correct charging position 4 2 3 Charging unit Top view elements g g Q Translux Wave Charging unit cover Hand piece holder with alignment key and replaceable charging unit contacts Light intensity sensor GREEN colour LED
13. of fire DO NOT THROW WATER ON A BURNING BATTERY A class C fire extinguisher according to European Regulation EN 3 must be used WARNING Damaged or exhausted battery disposal Dispose a damaged or exhausted battery after taking the necessary steps to prevent external short circuit by the followin method After having insulated the terminals of the battery with insulating tape dispose off under the law or in accordance with the local council BATTERY Information e Time to charge empty or new battery approx 3 hours D amp B NOTE NEW Battery first charging For the first charge this process will take about 3 hours New batteries or batteries stored for a long time may take more time to charge The battery will reach its full capacity after a few full charge discharge cycles IB NOTE Place the hand piece into the charging unit after each treatment or when not in use e Operating condition Operating temperature 10 C 50 F up to 35 C 95 F Relative humidity 45 to 85 RH Atmospheric pressure 800 hPa to 1060 hPa CAUTION The temperature and relative humidity ranges over which the battery can be charged is 10 C 50 F to 35 C 95 F and 45 to 85 RH Charging the battery at temperatures outside of this range may cause the battery to become hot or damaged Charging the battery outside this temperature range may also harm the performance of the battery or reduce tl battery s life expectancy e
14. signal that the residual charge level of the battery is adequate only for a few subsequent exposure cycles Place the hand piece in the charging unit and re charge the battery see paragraph 5 5 Contact Heraeus Kulzer or local authorised Customer Service agent Allow the hand piece to cool down for at least 4 5 minutes then start the next exposure by pressing the Start Stop button Note The hand piece upon reaching protection temporarily prevents fora operational temperature few minutes the use of the unit No manual reset required During an exposure cycle 3 beeps Overheating protection Allow the hand piece to cool down for at are emitted The hand piece has become least 4 5 minutes then start the next overheated in the course of use and exposure by pressing the Start Stop the temperature overload sensor has button activated The activation of the overheat protection temporarily prevents for a few minutes the use of the unit Malfunctions during charging phase During the battery pre qualification Replace the battery with a new one see phase battery condition completely paragraph 5 3 A beep signal is emitted every empty ref paragraph 4 2 4 and 5 5 second for a period of 30 seconds 2x and the battery status LED on the The electronics detects a defective or hand piece blinks YELLOW malfunction status of the battery and interrupts the charging proces
15. the exposure time is over by pressing again the Start Stop button Acoustical signal An acoustical signal beep is emitted when the Start Stop button is pressed to interrupt the cycle 6 2 Measurement of the Light Intensity The charging unit of the Translux Wave is equipped with an integrated light intensity meter 8 CAUTION Before each treatment always check the light intensity by using the light intensity meter integrated in the Translux Wave charging unit e Without applying pressure place the light guide flat and directly on the testing area 8 Activate the unit by pressing the Start Stop button whichever exposure time selected The light intensity measuring is immediately indicated by the 2 colour LED Symbol w placed at the bottom right of the testir area GREEN LED The light intensity is sufficient for the treatment YELLOW LED The light intensity is insufficient and patient s must not be treated CAUTION If the light intensity is insufficient to carry out the following controls and measures The light guide has not been inserted into the hand piece see paragraph 5 4 Inserting the fibre optic into the hand piece Check the light guide for contamination or defects Clean the light guide of any contamination see paragraph 8 Cleaning disinfection and sterilisation or replace the damaged light guide with a new one Use original Heraeus Kulzer light guides o
16. with urticaria solaris and c porphyria as well as on patients who have been treated with photosensitising medication A 3 2 2 3 2 3 The unit is not used on patients that have had surgery for eye cataracts which are particularly sensitive to light unle they use suitable protective measures such us the use of eye protectors spectacles that filter out blue light Patients whose anamnesis includes retinal diseases must have treatment with Translux Wave authorised by their ophthalmologist A specialist doctor is consulted in all potential risk cases WARNING Control of infections The light guide and the protective light cone must be cleaned disinfected and sterilised steam before every use The light guide and the protective light cone are delivered in NON STERILE condition and must be sterilised before being used for the first time See paragraph 8 4 1 2 Sterilisation parameters Safety Precautions WARNING RISK OF EXPLOSION Do not install the device where there is the risk of explosions The device must not be used where an inflammable atmosphere is present anaesthetic mixtures oxygen nitrous oxide etc Use the device in a well ventilated area WARNING Before using the unit check the mains power cable and plug for damage If they are damaged do not connect the unit to the mains Use only original spare parts or accessories trom Heraeus Kulzer GmbH Heraeus Kulzer provides a light guide suita
17. 00 1060 hPa 2 2 Transport damage Unpacking and inspection The unit is sensitive to shock because it contains electrical components Particular care must therefore be taken during transportation as well as storage The equipment shipped by Heraeus Kulzer was checked thoroughly prior to shipment The unit is correctly protected and packed when delivered Check the unit for damage after receiving it If it is damaged report this to the transportation company within 24 hours of delivery Under no circumstances install or work with a damaged unit and or accessories 2 3 Owner s obligations In addition to complying with the statutory regulations specified the owner must ensure that statutory requirements are observed amp implemented in the workplace i e he must train his personnel and comply with industrial safety legislation and all further valid regulations or laws in force For work on and with the unit written instructions in an understandable form and in the relevant language of the respective employees must be provided by the owner using the operating instructions and on the basis of the work to be carried out 2 4 Machine journal We recommend that you keep a machine journal and document all tests and major work e g servicing changes in it 3 Intended use The Translux Wave is a LED dental curing light unit intended for use in the oral cavity for the polymerisation of light curing dental materials such as
18. 6 2 CHARGING UNIT Replaceable charging contacts Damaged or highly soiled charging unit contacts that cannot be cleaned by following the procedures described in the above paragraph can prevent the contacts conductivity and consequently the battery charging In this case it is possible to replace the damaged charging unit contacts with new ones For additional information regarding replacement of charging unit contacts and spare part supply please contact your local Heraeu Kulzer subsidiary Working instructions Required tool screwdriver for Phillips Screws mid size 1 Remove hand piece out of charger base Disconnect charger from mains Unplug connecting wire from charger Turn charger upside down a SE 2 NL Remove 2 screws from the charging contact bridge see rear fold out cover point 12 m Pull out charging contact bridge Insert new contact bridge and fix connect in reverse way T Do not bend or contaminate the new contact bridge Do care about perfect insert and fixation Do not over tight the screws 9 Shelf storage Storage of the hand piece with battery during extended periods of non use Before or after a long inactivity period fully charge the battery or store it in the operating charging unit Although the built in safety circuit of the battery prevents the full discharge it is strongly recommended to fully charge the battery at least once every 5 months after inactivity 10 Dispos
19. Clean and disinfect the protective light cone with a soft cloth wetted with a mild disinfectant solution featuring a mild pH pH 7 according to the manufacturer s specifications Allow the disinfectant solution to dry 8 3 1 PROTECTIVE LIGHT CONE Inspection before the sterilisation Before proceeding with the sterilisation process carefully check the protective light cone for damaged surfaces veins discolouratic and contamination A WARNING Do not use a damaged protective light cone If damage is apparent replace the protective light cone with a new one A damaged protective light cone cannot provide enough protection from the unit light lf the protective light cone Is still contaminated repeat the cleaning and disinfection 8 4 LIGHT GUIDE and PROTECTIVE LIGHT CONE Packaging before the sterilisation The light guide and the protective light cone can be sterilised by using a single use medical steam sterilisation pouch of the appropriate size zd CAUTION The light guide and the protective light cone must be packed individually in a single pouch When sterilising multiple instruments in one autoclave ensure that the autoclave maximum load is not exceeded D WARNING Ensure that the inner pouch is large enough to contain the single instruments without stressing the seals or tearing the packaging 8 4 1 LIGHT GUIDE and PROTECTIVE LIGHT CONE Sterilisation 8 4 1 1 Sterilisation method Carry ou
20. K OF EXPLOSION Use only the Translux Wave charging unit and the input power supply which are provided with the unit to charge the har pieces battery Never attempt to charge the Translux Wave battery by using any other charging unit The use of any othe charging unit can result in the damage of the battery risk of explosion and fire Never use the Translux Wave recharging unit to charge other types of battery or other units with a rechargeable battery Use only original batteries from Heraeus Kulzer Do not pierce the battery with any sharp objects strike the battery with a hammer tools step on the battery or otherwise subject it to strong impacts or shocks Do not place the battery in fire or apply heat to the battery Never short circuit the end elements of the battery with any m objects due to the risk of burns fire and explosion Never carry or store the battery together with necklaces hairpins or other metal objects WARNING Do not disassemble or modify the battery Safety mechanisms are incorporated in the battery which if damaged may cause the battery to generate heat rupture explode or ignite WARNING Do not place the battery on or near fires or other high temperature locations Do not place the battery in direct sunshine Doing so may cause the battery to generate heat rupture or ignite Using the battery in this manner may also result in a loss of performance and shortened life expectance WARNING In case
21. MAX POWER lt 5 00 mW e IEC 60825 1 1993 A1 1997 A2 2001 Dominant wavelenght Min 440nm Max 465nm e Max power lt 5 00 mW e Dominant wavelength Min 440 nm Max 465 nm A N WARNING Diverging beams Do not observe the emission of light from the LED using optical instruments such as monocles magnifying glasses or microscopes from a distance of less than 100 mm as this could cause a risk of damage to your eyes Collimated beams Do not observe the emission of light trom the LED using optical instruments designed for use at a distance such as telescopes or binoculars since this could cause a risk of damage to your eyes In the event of the LED control circuit failure the LED radiation emission cannot exceed the value in the normal use condition of the medical equipment Labels are provided on the packaging of the device as indicated in the figure here above 5 Installation and putting into initial operation The following sections of this paragraph contain the information and instructions which must be followed to ensure successful and faultless operation of the device Before operating the Translux Wave follow the instructions in the sequence described below The medical system is in compliance with the safety standards only if it is installed by following the instructions described here bel The device must be installed in a suitable place that is handy for its use Place the charging unit on a sturdy dry flat and
22. REF 99000943 00 2013 08 Translux Wave GB Instructions for use Table of contents 1 1 1 1 2 1 3 2 1 2 2 2 3 2 4 Application In general EC Declaration of Conformity Manufacturer s declaration Instructions on using the unit safely Explanation of symbols and accompanying word s Transport damage Unpacking and inspection Owner s obligations Machine journal Oo WwW UU OQ KR BR BR WO 0 3 1 3 2 3 2 1 3 2 2 3 2 3 3 2 4 3 2 5 4 1 4 2 4 2 1 4 2 2 4 2 3 4 2 4 4 2 5 5 1 5 2 5 3 5 4 9 9 6 1 6 2 6 3 6 4 7 1 7 2 7 3 7 4 0 5 8 1 8 2 8 2 1 8 3 8 3 1 8 4 Intended use Description of the device Safety requirements General safety instructions on operating the device Safety Precautions BATTERY Safety precautions BATTERY Information LIABILITY Unit description Delivery contents Description of the control and operating elements Hand piece Alignment key Charging unit Acoustical signals hand piece LED information concerning the radiation emitted Installation and putting into initial operation Safety requirements during Installation Connection of the charging unit to the mains power outlet Inserting the battery into the hand piece Inserting the fibre optic into the hand piece Battery charging Operation Activating and deactivating the exposure cycle Measurement of the Light Intensity Sleep Mode Additional information on the unit operat
23. adhesives and filling materials that are activated in the 440 480 nm wavelength range NOTE Although most light curing dental materials are activated within this wavelength range in case of uncertainty verify the manufacturer s composite specifications or contact the manufacturer A N WARNING Qualified specialists The unit must only be operated by appropriately trained specialist personnel and the dentist see paragraph 2 3 Owner s obligations If the unit is used correctly it will not cause any known side effects 3 1 Description of the device The Translux Wave uses a source of light consisting of a very efficient mono chromatic LED diode with a wavelength comprised between 440 and 480 nm The entire light radiated by the Translux Wave is used to activate the camphorquinone photoinitiator This produces excellent polymerisation results with a significantly lower heat emission The Translux Wave is shipped with a 360 rotating light guide with 8 mm diameter The Translux Wave consists of a charging unit and a hand piece powered by a removable rechargeable Lithium ion battery The hand piece is equipped with a Sleep Mode to minimise the unit s energy consumption The hand piece switches to Sleep Mode if it is not used for a period of about 5 minutes The Translux Wave can operate with two different exposure cycles e Exposure with constant output cycle duration 10 seconds e Exposure with slowly increasing output
24. al NOTE IMPORTANT The device must not be disposed off in normal domestic waste For the disposal of spare parts or the unit please contact the Heraeus Kulzer subsidiary directly in your country Dispose unserviceable batteries and light guides according to the corresponding legal requirements in your country WARNING Damaged or exhausted battery disposal Dispose a damaged or exhausted battery after taking the necessary steps to prevent external short circuit by the followin method After having insulated the terminals of the battery with tape dispose off in accordance with your local council The conditions and precautionary measures for disposing of the device are subject to the valid legal provisions similar to any other electronic device which has become unusable WEEE WEEE Disposal of old equipment according to WEEE Electrical and Electronic Equipment Act ElektroG Troubleshooting 11 WARNING If the below steps do not solve the problem contact Heraeus Kulzer or a local authorised Customer Service agent DO NOT USE the Translux Wave and DO NOT ATTEMPT to service the unit as it may cause serious injury If the device does not seem to be working properly read this user manual again and then check the following table PROBLEM POSSIBLE CAUSE REMEDY The charging unit does not power on The input power supply is not Make sure that the input power supply is The GREEN LED 2 on the charging unit is swit
25. bile 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 Translux Wave is used exceeds the applicable RF compliance level above the Translux Wave should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Translux Wave b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended separation distances between portable and mobile RF communications equipment and the Translux Wave The Translux Wave is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Translux Wave can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Translux Wave as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter m output power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 P d 2 3 VP For transmitters rated at a maximum output power not listed above the recommended separation di
26. ble 1 use with the Translux Wave Other light guides must not be used Heraeus Kulzer GmbH will not accept any lability for damage resulting trom the use of non original Heraeus Kulzer spare parts or accessories BATTERY Safety precautions Heraeus Kulzer GmbH assumes no liability for battery problems that occur when the Safety Precautions listed in the paragraph below are not carefully adhered A WARNING Misusing the battery may cause the battery to get hot rupture or ignite and cause serious injury Be sure to follow the safety rules listed in the below paragraph Use original Heraeus Kulzer batteries only The use of non Heraeus Kulzer batteries or non rechargeable batteries and or primary batteries is a potential danger an can damage the device Keep the battery out of the reach of children Never open puncture or crush the battery it contains poisonous substances If the battery shows corrosion emits an unusual smell or loss of fluids remove the battery from the hand piece immediat Do not expose the battery to water or salt water or allow the battery to get wet Do not store the battery in high humidity lt in a place which may expose the battery to rain gt eb gt 3 2 4 In the event that the battery leaks and the fluid gets into one s eye do not rub the eye Rinse well with water and immediately seek medical care If left untreated the battery fluid could cause damage to eye WARNING RIS
27. ce The rating plate is fitted to the bottom of the charging unit Use only the switching power supply adapter which is provided with the device The use of any other power supply adapt can result in damage of the battery Do not connect the switching power supply adapter to the mains socket by using a multiple portable socket outlet NOTE The Translux Wave power supply unit 6 is supplied with three interchangeable adapters Fig 6 a Europe type 1 Fig 6 b UK type 2 Fig 6 c US JP_ type3 Select the correct adapter between the ones available Europe Type 1 UK Type 2 US JP Type 3 Each adapter has a slot into which the retaining latch on the power supply unit fits With the slot oriented toward the power supply unit place the adapter onto the power supply unit so that the slides on the adap are aligned with their respective slots on the power supply unit 4 Pressing down on the adapter and power supply unit slide the adapter into the power supply unit until a click is heard and the adapter is locked in place I NOTE Pressing down on the adapter during installation ensures that all the slides are held by the retainers on the power sup unit lf the adapter feels loose remove it and re install 5 To remove the adapter from the power supply unit press the latch retainer button marked with the word PUSH and slide the adapter away from the power supply unit and remove the adapter Retain unused adapters for
28. ched off connected to electrical supply outlet securely connected to electrical supply and or to the charging unit power outlet and to the charging unit power socket socket Power outlet carries no voltage Use a different power outlet The interchangeable adapter is not Carefully read paragraph 5 2 of this user properly inserted into the input power manual supply casing The power cable of the input power Replace the input power supply with a new supply is damaged one The input power supply and its cord cannot be separated from each other The input power supply is defective Replace the input power supply with a new one The charging unit is defective Contact Heraeus Kulzer or local authorised Customer Service agent The charging unit contacts are short Eliminate the cause of short circuit circuited If the short circuit condition persists replace the charging unit contacts with new ones Make reference to paragraph 8 6 2 Hand piece NOT inserted into the Hand piece without battery Insert the battery into the hand piece see charging unit paragraph 5 3 Hand piece in Sleep Mode Press the Start Stop button to bring the The light emission does not start p p p g hand piece out of the Sleep Mode when the Start Stop button Make reference to paragraph 6 3 is pressed and no information Empty battery Place the hand piece in the charging unit appears o
29. e battery Never attempt to charge the battery using another battery charging unit or power source due to risk of explosion and fire gt Insert the hand piece with the battery into the Translux Wave charging unit A beep confirms that the contacts are in the correct charging position 4 2 2 IMPORTANT NOTE Alignment key The alignment key 5 located at the back bottom part of the hand piece s case allows the correct insertion of the hand piece in the charging unit When inserting the hand piece into the charging unit the alignment key must be aligned with th slot positioned inside the charging unit gt Battery charging process The Green battery status LED on the hand piece starts blinking When the charging phase is complete battery fully charged the Green status LED is permanently lighted up IMPORTANT NOTE Defective battery In case during the charging phase the hand piece electronics detects a battery malfunction the changing process is interrupted and the status battery LED will blink YELLOW in colour In this condition a beep signal is emitted every second for a period of 30 seconds Replace the defective battery with a new one WARNING Use Heraeus Kulzer batteries only NOTE When the hand piece Is placed in the charging unit its functioning Is inactive The operativeness of the Start Stop butto is prevented The hand piece can be removed from the charging unit durin
30. ed below The customer or the user of the Translux Wave should ensure that it is used in such an environment Compliance Electromagnetic environment Guidance Group 1 The Translux Wave uses RF energy only for its internal function Therefore it s RF emissions are very low and are not likely to cause any interference in nearby electronic equipment including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Emissions test RF emissions CISPR 11 The Translux Wave is suitable for use in all establishments Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 Guidance and manufacturer s declaration Electromagnetic immunity The Translux Wave is intended for use in the electromagnetic environment specified below The customer or the user of the Translux Wave should ensure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment Guidance Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode The device continues to work regularly and in safety The device continues to work regularly and in safety
31. el 7 Alarm conditions 7 1 Faulty battery In the case of a defective battery the Battery status LED on the hand piece will continuously blink blinking YELLOW Fig a A beep sound is emitted every second for a period of 30 seconds a gt 033 IMPORTANT This error condition is detected only when the hand piece Is placed in the charging unit 7 2 Faulty LED When a malfunction LED condition is detected by the microprocessor the green curing mode LED C which is in use starts blinking Fig b blinking 7 3 Overheat protection If multiple curing cycles in rapid Succession occur normally after 18 consecutive cycles each lasting 20 seconds the built in temperature overload sensor may activate Once the overheat protection activates an acoustical signal 3 beeps is emitted at the end of the exposure cycle The activation of the overheat protection temporarily stops the use of the unit for a few minutes Allow the hand piece to cool down for at least 4 5 minutes then start the next exposure by pressing the Start Stop button NOTE The hand piece upon reaching operational temperature No manual reset required 7 4 BUILT IN Temperature overload sensor defective In case of a defective temperature overload sensor 4 beeps are emitted at the start of an exposure cycle 03 NOTE If the temperature overload sensor fault occurs during an exposure cycle the software allows completin
32. es that minor injury or device damage could occur if the advice is not followed Ca NOTE Implies advice that is not related to harm WARNING of explosion observe information and warnings in the chapters and sections marked with the following pictorial symbols WARNING of electric shock Before carrying out the cleaning and disinfection procedures disconnect the charging base from the electrical power source Disposal of old equipment according to WEEE Electrical and Electronic Equipment Act ElektroG Applied part Type B applied part in conformity with technical standards IEC 60601 1 Double insulation Class II device Power supply Alternate current Switching power supply plug polarity Centre positive Use in closed spaces only Device manufactured in conformity with directive 93 42 EEC including technical standards IEC 60601 1 and IEC 60601 1 2 WARNING symbol LED radiation Observe the information and dangers in the paragraph 4 2 5 Consult instructions for use CAUTION consult accompanying documents en ce ra A e q Operating switch Start Stop j j l j j f Registration certificate according to the ministry of health of the Russian federation Keep away from rain Storage temperature limitation 20 C 4 F to 40 C 104 F Storage humidity limitation 45 85 RH Storage atmospheric pressure limitation 5
33. g the charging process however the battery may not be full charged and may shorten the operational duration 6 Operation WARNING Check the condition of the device before starting the treatment Before each treatment always make sure that the device is in proper working order and that the accessories light guide and protective light cone are efficient If anything is noted during treatment do not carry out the treatment and contact Heraeus Kulzer or a local authorised Customer Service agent See paragraph 14 Service Do not use the device and its accessories if damage is apparent Prior to each use of the Translux Wave ensure that the emitted light intensity is suffici to guarantee the polymerisation Check the light intensity by using the light meter integrated into the charging unit see paragraph 6 2 Measurement of the Light Intensity WARNING Control of infections First use The accessories light guide and protective light guide are delivered in NON STERILE condition and must be sterilised before being used for the first time Every use Once used the accessories light guide and protective light guide must be reprocessed prior to reuse according to the procedures described in the paragraph 8 Cleaning disinfection and sterilisation 6 1 Activating and deactivating the exposure cycle The Translux Wave can operate with two different exposure cycles Exposure with constant output cycle duration 10 seconds
34. g the exposure No further exposure cycle is allowed by pressing the Start Stop button and 4 beeps are emitted Any further operation with defect temperature overload sensor is prevented 7 5 Battery low signal When after frequent use the battery charge drops to the minimum level the Translux Wave microprocessor permits another few cycles in any curing mode without re charging the battery This condition is signalled at the end of each cycle by 2 beeps Battery icon is blinking green Charge the battery At the end of a few cycles the remaining battery charge does not allow any further exposure cycle This condition is signalled by 2 beeps Battery icon is blinking green Charge the battery 8 Cleaning disinfection and sterilisation DISCONNECT FROM MAINS Before carrying out the cleaning and disinfection procedures disconnect the charging base from the electrical power sour WARNING Control of infections The light guide and the protective light cone are delivered in NON STERILE condition and must be cleaned disinfected a sterilised steam before being used for the first time as well as before every use Do not sterilise the hand piece and the charging unit Do not sterilise the battery 8 1 Disassembly BD Remove the protective light cone from the light guide BD Remove the light guide Rotate the light guide slightly and pull it out from the hand piece 8 2 LIGHT GUIDE Cleaning and d
35. he charging unit after cleaning Moisture inside the unit could cause damage 033 IMPORTANT Upon completion of the cleaning procedure make sure that the charging contacts inside the charging unit are perfect ary If necessary dry the contacts by blowing air onto them with compressed air 8 6 1 CHARGING UNIT Cleaning charging contacts 033 IMPORTANT After having carried out the cleaning of the charger s plastic casing always clean the charging unit contacts The charging contacts of the charging unit must always be free from possible soil composite and cleaning residues The charging unit contacts must be cleaned regularly at least once a week ana in any case always after having carried out the cleaning of the plastic casing Dirty contacts or contacts exposed to liquids like cleaner or disinfectants can negatively affect the charging process and prevent the battery of being charged E Clean the contacts of the charging unit with an alcohol dampened soft lint free cloth or cotton swab A CAUTION Do not use pointed or sharp objects to clean the charging unit contacts Do not spray or flood the contacts with liquids Do not bend or modify the shape of the charging unit contacts during cleaning Make sure that the charge contacts remain dry after cleaning and are not contacted by metallic and greasy parts If necessary dry the contacts by blowing air onto them with compressed air 8
36. ions Alarm conditions Faulty battery Faulty LED Overheat protection BUILT IN Temperature overload sensor defective Battery low signal Cleaning disinfection and sterilisation Disassembly LIGHT GUIDE Cleaning and disinfection LIGHT GUIDE Inspection before the sterilisation PROTECTIVE LIGHT CONE Cleaning and disinfection PROTECTIVE LIGHT CONE Inspection before the sterilisation LIGHT GUIDE and PROTECTIVE LIGHT CONE Packaging before the sterilisation O N DOA a oO Ff O O WO CO W _ 10 10 11 11 12 12 13 13 14 15 15 15 15 15 15 15 16 16 16 16 16 16 17 17 8 4 1 8 4 1 1 8 4 1 2 8 5 8 6 8 6 1 8 6 2 10 11 12 12 1 12 2 12 3 13 14 14 1 15 LIGHT GUIDE and PROTECTIVE LIGHT CONE Sterilisation Sterilisation method Sterilisation parameters HAND PIECE Cleaning and disinfection CHARGING UNIT Cleaning Casing CHARGING UNIT Cleaning charging contacts CHARGING UNIT Replaceable charging contacts Shelf storage Disposal Troubleshooting Technical specifications Electromagnetic compatibility EN 60601 1 2 Charging unit identification plate Hand piece serial number Warranty Service Service agents Contact in the countries Document history NOTE Please use the book icon to find the chapter images or further information on the fold out cover Please fold out front cover Please fold out rear cover Please
37. isinfection A CAUTION Do not use sharp or pointed instruments to clean the light guide since they could scratch the surface of the light guide an thus decrease light transmission Do not use cleaning disinfectant agents containing organic mineral and oxidising acids hydrogen peroxide chloride iodine bromide and solvents 1 Immediately after use any possible residue such as composite material must be removed from the end surface of the light guide Any polymerised composite should be removed by using ethanol and a plastic spatula or soft nylon brush may help in removing the material residue 2 Disinfect the light guide with a clean soft lint free cloth dampened with a mild disinfectant solution featuring a mild pH pH 7 according to the manufacturer s specifications Allow the disinfectant solution to dry 8 2 1 LIGHT GUIDE Inspection before the sterilisation Before proceeding with the sterilisation process carefully check the light guide for damaged surfaces discolouration and contamination A WARNING Do not use a damaged light guide If damage is apparent replace the light guide with a new one If the light guide is still contaminated repeat the cleaning and disinfection procedure 8 3 PROTECTIVE LIGHT CONE Cleaning and disinfection A CAUTION Do not use cleaning disinfectant agents containing organic mineral and oxidising acids hydrogen peroxide chloride iodine bromide and solvents gt
38. n the hand piece s display oe e aed There is not enough charge in the and re charge the battery see paragraph 2 beeps are emitted at the end of the exposure cycle The light emission does not start MEN when the Start Stop button is pressed The curing LED on the hand piece in use starts blinking GREEN blinking After several consecutive exposure cycles the light emission does not turn on when the Start Stop button y S is pressed and 3 beep 4 signals are emitted Electronics malfunction Defective battery Low battery charge The LED pack is defective Overheating protection The hand piece has become overheated in the course of use and the temperature overload sensor has activated The activation of the overheat battery to turn on the hand piece 5 5 Contact Heraeus Kulzer or local authorised Customer Service agent To verify if the battery is defective place the hand piece in the charging unit A prequalification sequence starts in which Translux Wave micro processor checks the battery status This prequalification sequence can last up to max 30 minutes If during this check sequence a beep signal is emitted every second for a period of 30 seconds and the battery icon on the hand piece is blinking YELLOW the battery is detected to be defective Replace the battery with a new one see paragraph 5 3 The 2 beeps
39. ng Power Supply Direct Plug In model PSACO5R 050 is considered the mean of isolating of the medical equipment from supply mains When the plug is connected the power supply adapter must be easily accessible Leave sufficient free space around it The medical equipment shall not be positioned to make difficult to operate on the disconnection device so on the plug of the Switching Power Supply Never short circuit the end elements of the battery with any metal object as it could cause a risk of burns fire and explosi The device is transportable but it must be handled with care Transport the device in a horizontal position Do not let the device be exposed to shaking or vibrations For sizes and weight see paragraph 12 Technical specifications WARNING RISK OF EXPLOSION Do not install the device where there Is the risk of explosions The device must not be used where an inflammable atmosphere is present anaesthetic mixtures oxygen nitrous oxide etc Install the device in a well ventilated area Connection of the charging unit to the mains power outlet 5 2 6880 Translux Wave The Translux Wave is supplied with a separated universal input unit 6 that accepts 100 to 240 V 50 60 Hz WARNING Before connecting the charging unit 6 to the mains network check carefully that the voltage and frequency of the mains network correspond to the values stated on the rating plate of the devi
40. nly A WARNING If the measures described above do not result in any improvement do not use the device for any treatment Switch of the unit disconnect the charging unit trom the electrical power source and ensure that unauthorised unit re activatior not possible Contact a Heraeus Kulzer s service partner or technically trained personnel authorised by Heraeus Kulz see paragraph 14 Service 6 3 Sleep Mode The hand piece is equipped with a Sleep Mode to minimise the unit s energy consumption Outside the charging unit all internal functions of the hand piece are automatically turned off Sleep Mode if it is not used for approximately 5 minutes In Sleep Mode the curing modes LEDs on the hand piece are turned off gt To terminate the Sleep Mode press the Start Stop button N The hand piece is ready for operation 6 4 Additional information on the unit operations 03 NOTE If the hand piece is placed in the charging unit before the curing cycle is terminated the light emission automatically switches off When the hand piece is placed in the charging unit its functioning is inactive The operativeness of the Start Stop butto The Translux Wave is equipped with microprocessors which continuously check the optimum charging parameters of the battery After every treatment the hand piece should therefore be inserted in the charging unit for storage irrespective of battery lev
41. on WARNING The user is responsible for testing the Translux Wave for its use and suitability for the intended purposes Never point the light towards the eyes Direct or indirect exposure of light into the eyes must always be prevented by wearing protective goggles that filter out blue light When curing position the light guide tip directly over the material that needs to be cured and avoid extraneous exposure to soft tissues Eyes gums soft tissue and other body parts must not exposed to the blue light if necessary these parts must be covered with protection Use a rubber dam to protect the sofi tissues i e gingiva during treatment Exposure must be restricted to the area of the oral cavity in which clinical treatment executed WARNING CONTRA INDICATIONS Do not use the Translux Wave on patients fitted with a pacemaker or other implantable electronic devices This also appli to the operator The unit must not be used by children the blind or the deaf and also not by on persons who are prone to possible epilept seizures The above pre named persons may not recognise the risks of use and operation Due to safety reasons for the operator and the patients with potential risk of epileptic seizures use and operation of the device is prohibited WARNING No modification of this equipment is allowed The owner user must ensure that The unit is not used on patients with a positive anamnesis after light testing for example
42. ontact with the composite material CAUTION Keep the light guide clean at all times to obtain full light intensity The light intensity is considerably reduced if The light guide is not in perfect condition scratched or chipped The light guide is not correctly placed in the hand piece The light guide has composite stains WARNING D A damaged light guide reduces the light intensity and must be replaced with a new one immediately Sharp edges may cause serious injury Use original Heraeus Kulzer light guides only WARNING Infection control D To make treatment as safe as possible for patients and operators the light guide and the protective light cone must be cleaned disinfected and sterilised before each treatment Follow the instructions listed in paragraph 8 Cleaning disinfection and sterilisation step by step Battery charging 5 5 CAUTION NEW Battery first charging The Translux Wave battery has been partially charged at the factory Therefore the battery must be fully charged before using the Translux Wave for the first time NOTE NEW Battery first charging For the first charge this process will take about 3 hours New batteries or batteries stored for a long time may take longel charge The battery will reach its full capacity after a few full charge discharge cycles WARNING RISK OF EXPLOSION Use only the charging unit supplied with the Translux Wave to charge th
43. osure cycles Normal exposure Class one The product has been tested and found to comply to IEC 60601 1 second edition and to IEC 60601 1 1 The product has been tested and found to comply to IEC 60601 1 third edition and to IEC 60601 1 2 third edition for electromagnetic compatibility EMC The hand piece is intended for use within the patient environment whereas th charger unit and the power supply adapter are not intended for use within the patient environment Note The patient environment is defined as an area 1 5 m from the patient as per IEC 60601 1 third edition and IEC 60601 1 1 Class Il Type B Applied Part Light guide with protective cone IP 20 Charging unit IP 20 Translux Wave Translux Wave Charging unit Switching Power Supply Direct Plug In manufactured by Phihong Technology CO LTD Model PSACO5R 050 Input 100 240 V Ny 300 mA 50 60 Hz Output 5 V ZZZ 1 A Max e Class II equipment Rechargeable Lithium ion battery Manufacturer Panasonic Model NCR 18500 Nominal Voltage 3 6 V Nominal capacity Typical 2000 mAh Model Translux Wave Operation Intermittent service 120 ON 40 OFF max 2 times running High luminosity LED Class 2M LED Product IEC 60825 1 Wavelength range 440 480 nm Lead free multi core rod 8 mm diameter Sterilisable in pre vacuum steam autoclave 4 minutes minimum at minimum temperature of 132 C
44. products purchased from a Heraeus Kulzer retailer or importer Heraeus Kulzer offers a warranty of 2 two years from the day of purchase for material and production faults During the warranty period Heraeus Kulzer undertakes to repair or replace if it chooses parts of the products deemed by Heraeus Kulzer to be faulty free of charge No provision has been made for complete replacement of the Heraeus Kulzer products Under no circumstances shall Heraeus Kulzer be liable for any direct or indirect personal injury or damage in the following cases e The unit was not used for its intended purpose e The unit was not used according to the instructions and specifications described in this manual e The electrical installation in the rooms in which the unit is used does not comply with existing legislation and relevant specifications e The assembly additions setting alteration and repair was not performed by Heraeus Kulzer specialist personnel e The conditions for storing the unit do not comply with the specifications listed in paragraph 12 Technical specifications Excluded from the warranty are transportation damage damage caused by improper use or negligence damage caused by connection to a power supply other than that specified for the equipment and damage to the control lamps buttons and all accessories The warranty shall become invalid if the unit is altered or repaired by personnel not belonging to Customer Service When making a wa
45. ree cloth or cotton swab A CAUTION Do not use sharp or pointed instruments to clean the hand piece contacts since they could scratch and damage their surface and thus worsen the conductivity with the charging contacts Before re using the hand piece make sure that the hand piece s surface and the charging contacts are perfectly dried If necessary dry the contacts by blowing air onto them with compressed air CHARGING UNIT Cleaning casing DISCONNECT FROM MAINS Disconnect the inout power supply from the power outlet and charging unit prior to cleaning disinfection WARNING The charging unit casing is not protected against the penetration of liquids Do not spray liquids directly onto the surface of the charging unit casing AN CAUTION DO NOT sterilise the charging unit It will no longer function and may cause a risk of serious damage electrical shock an fire Do not use solvents such as acetone isopropyl alcohol and hydrogen peroxide chloride iodine bromide phenol or othe aggressive solutions to clean the plastic surface of the charging unit These substances may be harmful causing discolouration and or damage to the plastic materials of the charging unit Do not use abrasive cleaners gt Clean and wipe the charging unit casing with a clean soft lint free cloth dampened with a mild surface cleaning agent featurin neutral pH pH7 according to the manufacturer s specifications Be sure to dry t
46. rranty claim the customer forwards the damaged unit at his own cost to the retailer or Heraeus Kulzer importe where he bought the unit The unit including the accessories must be well packed before shipping if possible in the original packaging A card containing the following information must be enclosed with the unit if returning the unit a Name address and telephone number of owner b Name and address of retailer importer c Photocopy of the delivery note purchase receipt for the unit by the owner which shows the date designation and serial numbe the unit d Description of malfunction The warranty does not cover transportation or any transportation damage In the event of damage caused by an accident or improper use or which occurs after expiration of the warranty period repairs will invoiced according to effective material and labour costs 14 Service 14 1 Service agents Contact in the countries 15 Document history 2012 08 Draft version for Prototypes 2013 08 First edition Subject to modifications Dated 2013 08
47. s blinking Hand piece placed in the charging Defect interrupt of charging contacts See paragraph 8 5 and 8 6 2 unit but the charging phase does not start The green battery status LED on the Improper contact between the Check if the hand piece has been inserted charging base and the hand piece in the correct orientation into the charging l unit hand piece is off Alignment key Make reference to the paragraph 4 2 1 points 4 and 5 Charging and or hand piece contacts Clean the hand piece and the charging unit are soiled contacts Make reference to the paragraphs 8 5 and 8 6 1 The light intensity measured with the Light guide not properly inserted into Check light guide for complete insertion in meter integrated in the charging unit the hand piece metal cone of the hand piece is insufficient Light guide output contaminated by Clean the light guide output Sr foreign material or composite Make reference to paragraph 8 2 The LED 7 gt on the charging unit residues that can interfere with light lights YELLOW au l with lig output Light guide damaged or aged Replace the light guide with a new one 12 Technical specifications Classification according to Directive 93 42 EEC Safety Standards Classification according to IEC 60601 1 Charging unit Power supply for the charging unit Power supply for the hand piece Hand piece Light source Light guide Settable exp
48. stance d in metres 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 according to the transmitter manufacturer Notes 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Heraeus Kulzer GmbH 12 2 Charging unit identification plate Pen manufacturer Gr ner Weg 11 63450 Hanau Germany Description of the symbols on the identification plate Charging yA Sl eal Wave 1 CE mark serial number 315AB000 Caution consult accompanying documents made in Italy Consult instructions for use Double insulation device complies with safety class II a Ff W N Disposal of old electrical and electronic equipment Applicable in the European Community and other European countries with AC DC Adapter Model PSACO5R 050 separate collection systems Phihong Technoloy CO LTD 12 3 Hand piece serial number The hand piece serial number is engraved on the l l 312AB000 bottom part of its casing CEN Engraved serial number 13 Warranty Each Heraeus Kulzer unit is subject to a stringent check and final inspection prior to delivery to guarantee perfect operation of the equipment For all new Heraeus Kulzer
49. t the sterilisation by means of a pre vacuum steam autoclaving gt CAUTION Never use any other sterilisation method because of potential incompatibility with the materials with which is made the li guide DO NOT USE the following sterilisation methods Ethylene oxide sterilisation hot air sterilisation flash autoclaving STERRAD sterilisation STERIS system or comparable sterilisation systems DO NOT sterilise the light guide and the protective light cone by using Hydrogen peroxide peracetic acid system formaldehyde and glutaraldehyde sterilisation 8 4 1 2 Sterilisation parameters e Minimum sterilisation parameters that provide a 10 sterility assurance level SAL Cycle Type Minimum Temperature Minimum Exposure Time pouch Minimum Dry Time 132 C 3 C Pre vacuum 20 minutes 270 F 5 F CAUTION Do not exceed 135 C 275 F 5 8 5 HAND PIECE Cleaning and disinfection A WARNING The hand piece Is not protected against the penetration of liquids Do not spray liquids directly onto the surface and charging contacts of the hand piece Cleaning and disinfectant agents must not enter the hand piece NEVER immerse the hand piece in liquids NEVER clean the hand piece under running water Do not sterilise the hand piece Risk of serious damage electrical shock and fire gt Clean and wipe the hand piece casing wi
50. th a clean soft lint free cloth dampened with a mild surface disinfection agent featurir a neutral pH pH7 according to the manufacturer s specifications Allow the disinfectant solution to dry or dry the residual disinfectant on the hand piece casing with a soft lint free cloth A CAUTION Do not use solvents such as acetone isopropyl alcohol and hydrogen peroxide chloride iodine bromide phenol or othe aggressive solutions to clean and disinfect the plastic surface of the hand piece These substances may be harmful caus discolouration and or damage to the plastic materials of the hand piece Do not use abrasive cleaners IMPORTANT Cleaning of the charging contacts of the hand piece After having carried out the cleaning disinfection of the hand piece s plastic casing always clean the charging contacts which are positioned in the bottom part of the hand piece The charging contacts of the hand piece must always be free fi possible soil composite and cleaning disinfectant residues IMPORTANT The hand piece charging contacts must be cleaned regularly at least once a week and always after having carried out t cleaning and disinfection of the hand piece plastic casing Dirty charging contacts or contacts exposed to liquids like cleaner or disinfectants can negatively affect the charging process and prevent the battery of being charged cican the charging contacts of the hand piece with an alcohol dampened soft lint f
51. ure The residual charge level of cycle the battery is sufficient for a e Battery icon is blinking green few exposure cycles Place hand piece into charger base for charging SIGNAL WHEN BATTERY EMPTY e 2 beeps without activation of exposure cycle Following exposure cycle e Battery icon is blinking green can t be activated Place hand piece into charger base for charging DEFECTIVE BATTERY SIGNAL Only with hand piece placed into the charging unit e 1 beep every second for a period of 30 seconds The battery status LED lights YELLOW LED Light source defective No acoustical signal emitted The green exposure cycle LED in use blinks OVERHEATING CONDITION s 3 beeps and the electronics allows termination of the exposure cycle in use BUILD IN Temperature overload sensor defective e 4 beeps at the start of an exposure cycle Charging circuit of the hand Two green LED 10 s 20 s on the piece defective hand piece blinking Note This condition is detected only with hand piece placed inside the charging unit 4 2 5 LED information concerning the radiation emitted This device uses high luminosity LEDs Class 2M IEC 60825 1 AA LED Radiation LED RADIATION i i i i i H hater SANE ATO TAE CE OREN RETS Do not stare into the beam or view directly with optical instruments WITH OPTICAL INSTRUMENTS CLASS 2M LED PRODUCT e Class 2M LED Product IEC 60825 1 1993 A1 1997 A2 2001
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