dent weld - manual - english
Contents
1. To sterilize the parts listed above it is suggested to use the standard autoclave sterilization 1340C for 20 minutes Since the number of sterilization cycles in autoclave is limited the operator is advised to check carefully the sterilized pieces after every cycle in order to verify their integrity Specifically verify that they do not have any scratch break or modification to dimensions structure or color In case of any damage or doubt about the integrity of a component replace the piece immediately In any case it is advisable to replace tongs and electrodes after 200 sterilization cycles Manual code Model Device code Pag 31 DOC MAN DWD rev 100201 DENT WELD PASEOEWD002 1 D swiss WEGMAN medical equipment Important notes on waste disposal INFORMATION FOR USERS In accordance with article 13 of Law Decree No 151 dated 25 July 2005 Enforcement of directives 2002 95 EC 2002 96 EC and 2003 108 EC related to reduction of dangerous substances in electrical and electronic devices and to waste disposal The symbol of the crossed out rubbish bin shown on the device or on the wrapping indicates that the product must be collected separately from other waste at the end of its useful life It is forbidden then to dispose of this equipment like any other urban waste The user who needs to dispose of the used or disused device may contact a waste collection center for waste electr2. Manual code Model Device code Pag 10 DOC MAN DWD rev 100201 DENT WELD PASEOEWDO02 1 rnedical equipment D swiss WEGMAN Contraindications ATTENTION This paragraph specifically concerns safety instructions It is recommended that particular attention be paid to reading it and all instructions be followed Dent Weld produces very high current pulses and consequently remarkable electromagnetic fields However it is suitable for use in any medical or surgical context its emission limits widely comply with the standards imposed by regulations on electromagnetic compatibility for medical devices However in the absence of sufficient information about it it is advised no to use Dent Weld with patients or operators carrying pace makers implanted defibrillators or other electronic devices for life maintenance The electrodes and the intraoral tongs are made of materials usually well tolerated by most people but it cannot be excluded that some subjects may be allergic to them Such metals are Brass Nickel Steel AISI 316 Copper Chrome It must be pointed out that the patient gets in contact with only few parts of the handpiece and for a very short time Therefore depending on each case the dentist will decide whether or not to use the device after an evaluation of the side effects which must be tolerable and lesser than the benefits Side effects It is recommended that particular attention be p
3. The compliance with regulations on electromagnetic compatibility is important to warrant the safety of devices and systems since electromagnetic phenomena with different intensity levels occur in the location where the devices are usually used Dent Weld must be installed and set according the EMC Electromagnetic Compatibility standards listed in this handbook ATTENTION Portable and mobile RF communication equipments could affect the operation of the device AN ATTENTION Dent Weld is not to be used near nor lain upon or under other devices Manual code Model Device code Pag 15 DOC MAN DWD rev 100201 DENT WELD PASEOEWD002 1 D swiss WEGMAN medical equipment Position and size of the cables A Network connection cable 3 x 0 75 mm B Pedal cable coaxial cable 1 x 0 25 mm sleeve lt 3 m C Cable for handpiece 1 x 16 mm 1 x 16 mm a network connection cable Dent Weld c Pliers cables b Pedal cable lt 3m View from above Map strongly recommended to use only the cables and accessories supplied by the manufacturer The use of any other cable can cause malfunctioning of the device an increase of emissions or a decrease of immunity ATTENTION Do not use cables and accessories different from the ones indicated It is Manual code Model Device code Pag 16 DOC MAN DWD rev 100201 DENT WELD PASEOEWDO02 1
4. UP UP It means that on first start UP key must be pressed four times to insert the password If a wrong password is inserted the device will ask for it again As soon as the device recognizes the correct password it will wait for five seconds while if the password is to be changed the CHANGE key must be pressed Then the display will ask for the new password that may be recorded pressing a combination of four keys choosing between UP and DOWN After the sequence has been keyed in press and keep on pressing the CHANGE key to memorize it Once the correct password is inserted the last program used will be displayed If it is the first start the first program of the list will be displayed Manual code Model Device code Pag 27 DOC_MAN DWD rev 100201 DENT WELD PASEOEWDO02 1 D swiss WEGMAN medical equipment Program selection By pressing the CHANGE key the program parameter will flash on indicating that such parameter is now active By pressing the UP and DOWN keys it is possible to scroll through all programs stopping at the chosen one As the programs are scrolled their related parameters are displayed Welding power modification Once a treatment has been selected all related parameters are set automatically It is suggested to use the pre set parameters but if the user decides to change power parameter it is sufficient to press the C
5. D swiss WEGMAN medical equipment TABLE OF CONTENTS Chapter 1 Introduction o ooooncccccconnccnnncnnoncnnnnonnnnnnnnnnnrennnnnnnrrnrnn rere sears senna nennen nnn nenne 4 Yee EI iio 4 Symbol Attention eie arre tee ali 4 CE Marking compliance with regulations and directiVeS cccoooocccnccnonnccnnnnnancncnnnnancnnnnnnnranennnnnennnnnnnos 5 Product IdentificatiOm isisisi neiere innnan iese eraa UM 6 Accessories supplie disisian E aa r Eea aa a LA a M 6 Accessories available by separate order eesssesessssessssseeeen nennen nennen nennen nnne 6 Manufacturer s IAEA Mee 6 Chapter 2 Scope of se 5 reos iii ies po ES ENTE Ex e YE YR RR ERENKRRE E EENR T EIE DER YERES 7 ur gel C M 7 y veje Ifer ie ai oC 8 Principle OF ACUON DH 8 Benefits of using intraoral welding oooooncccconnncnnnnnnncnnnenononennnnonnnnncnn nn rnrrnn nennen nnne 9 COMEPAIMGI CAT ONS acciona a 11 Side MC ES e 11 Chapter 3 Labels coords 13 Label 1 Handpiece inicia 13 Label 2 Pedal COME rr in 13 Label 3 Conformity Markos A AA N EE ES 14 Labels Storage COn Sii oi A A AA A A 14 Chapter 4 Warnings iieiaeie a dd cin 15 Requirements for electromagnetic compatibility occcooonncnnnnononnnnnnnnanenennnnnnnnnnnnnnncnrcnnnnnnrrrnnnnnns 15 Manual code Model Device c
6. Device code Pag 25 DOC MAN DWD rev 100201 DENT WELD PASEOEWDO002 1 D swiss WEGMAN medical equipment Pre operative sequence Take all components out of the packaging and lay them on a horizontal surface Remove all plastic wrappings from the components Keep all wrappings and packaging available for any future handling of the device Arrangement and connection of the handpiece 1 Insert the electrodes on the ends of the tongs and fasten them by tightening the setscrews The two electrodes must be inserted as shown in the picture 2 Connect the cables of the handpiece to the tongs by inserting the female connector in the proper connector and rotate it clockwise until completely locked 3 Connect the other cable end to the device by inserting the male connector in the proper connector and rotate it clockwise until completely locked A ATTENTION On delivery the tongs are provided within an nonsterile wrapping The tongs must be sterilized before use Installation of equipment 1 Insert the pedal connector in the proper socket located on the front face of the device 2 After checking carefully the network connection cable integrity connect it to the proper power socket placed on the back face of the device just pressing it lightly 3 Before such operation make sure that the network connection cable is disconnected from the power system 4 Check that Dent Weld is switched off an
7. CHAPTER 3 LABELS Permanently affixed to the device are the following labels clearly visible during operation maintenance and repair of the equipment Label 1 Handpiece EL A reminder label representing the tong shaped handpiece is placed exactly on the point where the connecting cables must be inserted Label size 15 x 6 mm Label 2 Pedal Connector P ail A label is placed to indicate the exact position where the control pedal must be connected Label size 10 x 10 mm Manual code Model Device code Pag 13 DOC MAN DWD rev 100201 DENT WELD PASEOEWDO02 1 rnedical equipment D swiss WEGMAN Label 3 Conformity Mark Swiss amp Wegman s r l Mod Dent Weld Cod PASEOEWD002 1 S N 091220 A 230VAC 10W Fuse T2 5A Class I BF CE 0476 Made in Italy An identification label is positioned on the back side of the device Label size 60 x 30 mm Label 4 Storage Conditions A label indicating the storage conditions is positioned on the top part of the case Label size 105 x 45 mm Manual code Model Device code Pag 14 DOC MAN DWD rev 100201 DENT WELD PASEOEWDOO2 1 D swiss WEGMAN medical equipment CHAPTER 4 WARNINGS Requirements for electromagnetic compatibili It is recommended that particular attention be paid to reading it and all instructions be 1 ATTENTION This paragraph specifically concerns safety instructions followed
8. City State BRIEF DESCRIPTION OF THE PROBLEM Write a brief description of the problem indicating conditions under which it first occurred Furthermore indicate whether or not the product can still be used FREQUENCY If applicable indicate how often the problem happens ex it suddenly turns off once a day Manual code Model Device code Pag 34 DOC_MAN DWD rev 100201 DENT WELD PASEOEWDO002 1 D swiss WEGMAN medical equipment Preventive maintenance Yearly and whenever it is considered appropriate it is advised to perform the following procedure to check the correct function of the equipment and prevent any breakage Unplug the network connection cable Check if the case is in a good condition without signs of damage such as rust paint scratches dents breakages cracks Open the upper cover by unscrewing the 4 side screws and lay the cover aside being careful not to stretch excessively the cables that connect the upper cover to ground Remove any dust from the inside by using compressed air Do not touch any internal parts Check that the wiring is in good condition without any sign of damage or blackening Reposition the cover and close the device Check that all labels are in good condition by comparing them with those illustrated in this handbook Check that the network connection cable is in a good state without any sign of breakage or wear Test the protection cable continuity Connect the net
9. Emissions D swiss WEGMAN medical equipment Guide and manufacturer s declarations Electromagnetic emissions Dent Weld is intended for use in the electromagnetic environment specified below The customer or the user of the system should assure that it is used in such an environment Emission Test Compliance Electromagnetic environment guide Group 1 Dent Weld uses RF energy only for its internal RF emissions function Therefore its RF emissions are very low CISPR 11 and are not likely to cause any interference in nearby electronic equipment Dent Weld is suitable for use in all locations Harmonic emissions Class A including domestic environments and those directly IEC 61000 3 2 Voltage Fluctuation flicker emissions IEC 61000 3 3 Compliant connected to the public low voltage power network that supplies buildings used for residential purposes Manual code DOC MAN DWD rev 100201 Model Device code Pag 17 DENT WELD PASEOEWDOO2 1 Immunity Es SWISSSIWECMAN rnedical equipment Guide and manufacturer s declarations Electromagnetic immunity Dent Weld is intended for use in the electromagnetic environment specified below The customer or the user of the system should ensure that it is used in such an environment Immunity Test IEC 60601 test level Compliance level Electromagnetic environment Guide Electrostatic disch
10. It is advised that the room intended for use be cleared out of any extraneous material The location should be clean and tidy Dent Weld can be installed on a table or an appropriate tray attached to the dental chair unit The supporting surface must be stable resistant without dips disconnections or cracks Verify that the electrical system be installed correctly according to the regulation standards and be connected to ground Check that the electrical power supply complies with the device electrical requirements in particular the network voltage the available power and the network frequency must be in accordance with the specified technical features of the device The equipment must be placed at a safe distance from other devices with which electromagnetic interference may occur Do not place the equipment in direct contact with walls or objects that could obstruct the natural air flow The environment must be maintained at a temperature between 10 and 35 C and humidity between 30 and 90 Manual code Model Device code Pag 22 DOC MAN DWD rev 100201 DENT WELD PASEOEWDOO2 1 D swiss WEGMAN medical equipment Device handling The whole package containing Dent Weld and its accessories weighs about 7 kg Therefore adequate personnel is required for unloading and transporting the equipment deficiency in following all precautions advised for loading unloading and handling the 1 ATTENTION The manufacturer dis
11. Weld is designed to be used only by specialized dental staff in dental clinics or in health facilities Principle of action This device has a very simple working principle In order to weld two metals it uses the Joule effect according to which the current passing through a resistance produces an energy which is completely transformed into heat equal to IX Ix Rx T Iis the current passing through the resistance R during time T The total resistance is composed by the resistance of the metals to be welded and the contact resistance between those metals The contact resistance is much higher than the metal resistance so that most of the power and heat thereby will be localized exactly on that point Current passes through the metals by means of two electrodes that hold the metals tightly together and are connected to a discharge loop The contact resistance between electrodes and metals as well as the resistances characteristic of the electrodes must be smaller than the resistance between the metals to be welded so that all the power is localized on the welding point and is not dispersed along the remaining parts of the discharge loop For this reason it is strongly recommended to keep the electrodes the tongs and the contacts of the connecting cables clean and in a good state of maintenance As the total resistance is very small it is necessary to supply high currents to produce enough energy and thereby enough heat to melt the metal The cur
12. Working 8 hours a day it is expected to last more than 5 years After this time it is necessary to replace it Manual code Model Device code Pag 36 DOC MAN DWD rev 100201 DENT WELD PASEOEWDOO2 1 CHAPTER 7 SPECIFICATIONS D swiss WEGMAN medical equipment Label data Manufacturer SWISS amp WEGMAN s r l Model Dent Weld Power supply 230V AC Network frequency 50 60 Hz Input average power 10 W Maximum peak power during welding phase 1 KW Medical Device Class 2B Insulation Class I Handpiece Type BF Protection against anesthetic Equipment not suitable for use in the presence of a flammable anesthetic mixture with oxygen or nitrous oxide IP degree of protection IPXO Mode of use Continuous operation Working conditions Temp RH Press 10 C 350C 30 90 700 1100 hPa Storage conditions Temp RH Press 50C 500C 30 90 700 1100 hPa External connections Pedal Size 30x22x17 cm length x width x height Weight About 7 kg Main parameters Power 20J 300J Emission mode Selectable Single Double pulse Time between two pulses 5s Mode of use Continuous Welding power stability 20 Manual code DOC_MAN DWD rev 100201 Model Device code DENT WELD PASEOEWDOO2 1 Pag 37 E SWISSSWEGMAN medical equipment CHAPTER 8 LIABILITY FOR DEFECTIVE PRODUCTS We guarante
13. in the oral cavity thanks to their shape The handpiece has been designed to apply high pressure with the electrodes in order to hold the metals to be welded in the correct position before and during the welding process Before starting the welding phase through pedal pressure it is necessary to make sure that the tongs are correctly placed and steady When pressing the pedal welding does not occur immediately because it is preceded by a phase of power charge before the discharge release During this time a beep will be heard The welding process is over only when the light signal turns off Do not move nor take off the tongs from their welding position until the beep stops sounding In double emission mode where the welding pulse is preceded by a pre heating pulse this phase lasts longer because it consists in two charge phases and two discharge phases Anyway the welding process takes from 0 5 to 2 5 seconds When the welding phase is over it will not be possible to repeat it for 5 seconds The device s internal microprocessor inhibits the use of the pedal to prevent unintentional activation of the welding process Indeed 5 seconds are considered as the minimum time needed to remove and reposition the tongs Manual code Model Device code Pag 29 DOC MAN DWD rev 100201 DENT WELD PASEOEWD002 1 Errors and alarms D swiss WEGMAN medical equipment Errors indicate a malfunction of the device In case any ERROR occ
14. product is CE marked according to the European guidelines in particular 1 Directive 93 42 CEE on medical devices adopted in Legislative Decree 0476 46 97 2 Directive 2002 95 CE RoHS adopted in Legislative Decree 151 2005 3 Directive 2002 96 CE RAEE adopted in Legislative Decree 151 2005 Conformity was obtained by complying with the following regulations CEI EN 60601 1 1998 Electromedical devices Part 1 General Safety Standards CEI EN 60601 1 2 2003 07 Electromedical devices Part 1 General Safety Standards 2 Collateral Standard Electromagnetic compatibility Limitations and tests e CEI EN 60601 1 4 1997 Electromedical devices Part 1 General Safety Standards 2 Collateral Standard Programmable electromedical systems UNI CEI EN ISO 14971 2007 Medical devices Application of risk management to medical devices e UNI EN ISO 9001 2008 Quality management systems UNI EN ISO 13485 2004 Quality management systems Medical Devices Manual code Model Device code Pag 5 DOC MAN DWD rev 100201 DENT WELD PASEOEWDO02 1 D swiss WEGMAN medical equipment Product Identification This handbook has been written referring to the following device e Dent Weld Intraoral welder for dental use Accessories supplied Item HANDPIECE SURGICAL TONGS PAMANPINOO1 1 COPPER ELECTRODES CEELTEWD6090AAA CONTROL PEDAL PAINTPEDOO3 1 CONNECTING CABLES FOR TONGS PACAVEWDOO1 1 Acce
15. DO002 1 E SwISSSWEGMAN medical equiprment Disconnect all cables from the main case especially the network connection cable Keep the device packed in a dry place with a temperature between 59 and 509C and humidity between 30 and 9096 Main elements Front face On the front face of the device the following elements can be observed 1 2 3 4 5 6 7 8 9 Alarm status led indicator identified with Check Main liquid crystal display Wait Ready buttons identified with the symbol O Button to select the parameter modification identified with the symbol C Button to increase the selected parameter identified with the symbol A Button to decrease the selected parameter identified with the symbol V Power on led light identified with Power ON Ready status led indicator identified with Ready Status verification led indicator identified with Welding 10 Error status led indicator identified with Alarm 11 Socket for the pedal connector identified with the symbol Ta 12 Two connectors to insert the cables of the handpiece Manual code Model Device code Pag 24 DOC_MAN DWD rev 100201 DENT WELD PASEOEWDOO2 1 medical equipment E SwISGSWEGMAN Back face On the back face we can observe 1 Master switch Connector for network power socket Power fuses 2 x T2 5 Ampere gt N Identification label Intraoral tongs Manual code Model
16. F communication equipments and Dent Weld Dent Weld is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of Dent Weld can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipments transmitters and Dent Weld as recommended below according to the maximum output power of the communication equipment Rated maximum Separation distance according to transmitter frequency m output power of transmitter W From 150 kHz to From 80 MHz to From 800 MHz to 80 MHz 800 MHz 2 5 GHz d 1 2 VP d 1 2 VP d 2 3 VP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer 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 Recommended separation distances Examples Manual code DOC_MAN DWD rev 100201 Model Devic
17. HANGE key until the power parameter flashes to indicate that such parameter is now active Then use the UP and DOWN keys to set the value required Power can be set up from a min of 20 J to a max of 200 J Welding mode modification Once a program has been selected all related parameters are set automatically It is suggested to use the pre set parameters but if the user decides to change the emission mode parameter it is enough to press the CHANGE key until the related parameter flashes to indicate that such parameter is now active Then use the UP and DOWN keys to set the required value It is possible to select 2 modes e SINGLE one welding pulse DOUBLE the welding pulse is preceded by a current pulse equal to a quarter of the welding power to pre heat the joint to be welded Device activation Once the required parameters have been selected press the READY button to switch the device to the ready status On pressing the READY button the ready status indicator will light up with red Position the handpiece on the spot to be welded Press the pedal switch to trigger the current discharge Manual code Model Device code Pag 28 DOC MAN DWD rev 100201 DENT WELD PASEOEWD002 1 D swiss WEGMAN medical equipment Positioning the handpiece The handpiece consist of a pair of tongs on whose ends are two copper electrodes The electrodes can easily be inserted
18. aid to reading it and all instructions be 1 ATTENTION This paragraph specifically concerns safety instructions followed A misuse of the device can bring about unwanted side effects sometimes dangerous The main side effect to bear in mind is the risk to burn soft tissues near the weld site within the oral cavity This device has been designed to minimize the risk of such side effects In any case understanding such risks and using Dent Weld properly prevent the occurrence of such effects The current discharge loop can only take place within the circuit formed by welding device cables tongs and joints to be welded However during the welding process the absence of other conductors within the oral cavity is recommended to avoid the occurrence of unexpected discharge loops Manual code Model Device code Pag 11 DOC MAN DWD rev 100201 DENT WELD PASEOEWDOO2 1 D swiss WEGMAN medical equipment The heat produced during the welding process remains confined within the welding core and the increase of temperature along the rest of the metal is negligible In spite of this it is advised that patients avoid leaning their tongue on the metal joints to be welded The danger of spark formation in the welding phase is significantly reduced thanks to the tongs clamping force which prevents the formation of empty spaces during the discharge phase In fact a reduction of metal thickness takes place because of local meta
19. arge ESD IEC 61000 4 2 6 kV at contact 8 kV on air 6 kV at contact 8 kV on air Floors should be wood concrete or ceramic tile If floors are covered with synthetic materials the relative humidity should be at least 3096 Electrical fast transient burst IEC 61000 4 4 12 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Network power quality should be that of a typical commercial or hospital environment Surge 1 kV differential mode 1 kV differential mode Network power quality should be that of a typical commercial or IEC 61000 4 5 2 kV common mode 2 kV common hospital environment mode lt 5 UT lt 5 UT Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 gt 95 dip in UT for 0 5 cycles 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT for 5 sec gt 95 dip in UT for 0 5 cycles 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT for 5 sec Network power quality should be that of a typical commercial or hospital environment If the user of the system needs continuous operation during power blackouts it is recommended that Implant Weld 300 be powered from an uninterruptible power supply UPS or a battery Networ
20. claims all responsibility in case of noncompliance or device and its accessories Check upon delivery Upon delivery it is important to check the integrity and completeness of the material in the presence of the carrier In particular it is necessary to check The number of packages and their correspondence with the related codes The external packaging conditions and possibly the presence of damaged internal parts The package contents compared with the attached packing list It is important to point out immediately to the carrier any nonconformity found upon checking the delivery or sign an acceptance of the goods under reserve In accordance with national and international laws goods are transported at the customer s risk Besides the goods are always shipped without insurance coverage unless clearly specified in the contract Package contents The following items will be found inside the package 1 An intraoral welder Model Dent Weld A control pedal A network connection cable Welding tongs Two fuses Ov Ur Ro 09 TJ The user s manual to be read carefully before any operation Subsequent handling If handling or shipping of the equipment is needed it is recommended to follow these instructions For shipment use the packaging material provided with upon delivery Be sure that the master switch is turned off Manual code Model Device code Pag 23 DOC MAN DWD rev 100201 DENT WELD PASEOEW
21. d connect the network connection cable plug to the network socket AN ATTENTION Make sure that the network socket has an efficient ground connection Make also sure that it is compatible with absorption standards indicated in the specifications Manual code Model Device code Pag 26 DOC MAN DWD rev 100201 DENT WELD PASEOEWDO02 1 D swiss WEGMAN medical equipment ATTENTION Do not use any adapter nor multiple sockets of any kind ATTENTION Be sure that the electrical network complies with the regulation standards and is well connected to ground ATTENTION Check that electrical network complies with the electrical requirements of the device In particular it should be verified that the network power is in accordance with the specified technical features of the device in its availability and frequency gt gt gt Now Dent Weld is installed and ready to be used Operation sequence Before switching on for the first time wait at least two hours until the device temperature is adapted to the room temperature Switch on the back button The switch on status is signaled by a green light corresponding to the label Power ON The main display will show the software version for a while then it will ask for a password Password The Dent Weld password consists in a combination of four keys chosen between UP and DOWN The pre set value is UP UP
22. d strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Ka 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 mobile radios amateur radios 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 Dent Weld is used exceeds the applicable RF compliance level above Dent Weld should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating Dent Weld Manual code Model Device code Pag 19 DOC MAN DWD rev 100201 DENT WELD PASEOEWDO02 1 D swiss WEGMAN medical equipment B Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3V m Recommended separation distance between portable and mobile R
23. e code DENT WELD PASEOEWDO02 1 Pag 20 medical equipment D swiss WEGMAN General Risks ATTENTION This paragraph specifically concerns safety instructions AN It is recommended that particular attention be paid to reading it and all instructions be followed in order to avoid fire or explosion risks Intrinsic features of the device may present fire or explosion risks in case of misuse It is recommended to follow these simple rules Never use flammable gases while using the device Any flammable solvent or solution must be evaporated before using the device Avoid using potentially flammable anesthetics or gases such as oxygen and nitric oxide The saturation of oxygen may set fire to some kinds of materials such as cotton or cotton wool if exposed to sparks produced by the electric discharge Besides it is important that all flammable solutions used normally for disinfection be evaporated before using the device Manual code Model Device code Pag 21 DOC MAN DWD rev 100201 DENT WELD PASEOEWDOO2 1 D swiss WEGMAN medical equipment CHAPTER 5 MODE OF USE Installation During transportation and installation the device must be handled very carefully it is recommended that the requirements here described be fulfilled The first operations to perform are arranging the place to position the equipment checking the parts received and installing the device Place of use
24. e to our customers that on purchase the device and its accessories do not have any defect and that being it a device for professional use should any malfunction occur during the first year from purchase date it will be covered by warranty The warranty is not applied to any defect damage or breakdown due to misuse wrong maintenance negligence or noncompliance with the dictates of the user s manual Our warranty does not include support to repair any damage resulting from handling by unauthorized personnel In order to get a repair replacement under warranty it is necessary to communicate the defect in advance by fax letter or e mail sending the form Technical Service Request properly filled up The request will be verified by our technical staff and in case it is an intervention covered by warranty the most suitable manner for providing support will be communicated The warranty includes all costs of labor and any repaired or replaced part that our technical staff considers to be the cause of the defect found provided that such defect is not due to the user s negligence as mentioned above The warranty excludes all costs due to replacement of components subject to wear Such components are listed in the section of the user s manual concerning maintenance procedures The equipment may be repaired or replaced depending on cost effectiveness Transport or shipment of defective equipment from the user s premises to the technical suppor
25. e to replace the components considered defective with equal ones not with equivalent ones e after repairing to perform all tests for preventive maintenance to perform an electrical safety verification Manual code Model Device code Pag 33 DOC MAN DWD rev 100201 DENT WELD PASEOEWDOO2 1 E SWISSSWEGMAN medical equipment Technical service request Product name Code S N Purchaser Address Date Contact person Tel e mail Place of departure address Place of delivery address Brief description of the problem Frequency Date Signature Fill in the blanks according to the following instructions PRODUCT Indicate the product name as shown on the label attached to the back face of the device CODE Indicate the code as shown on the label attached to the back face of the device S N Indicate the S N as shown on the label attached to the back face of the device PURCHASER Indicate the company name of the buyer as written on the invoice ADDRESS Indicate the buyer s address DATE Indicate the date of the delivery note that accompanied the shipment KEY PERSON Indicate the contact person s name and surname PHONE E MAIL Indicate the contact person s phone number and or e mail DEPARTURE PLACE Indicate address of the place where the device is presently DELIVERY PLACE Indicate address of the place where the device must be delivered after technical service has been made Addressee Street ZIP code
26. ed of an endosteal screw emerging out the soft tissue with a post that allows rehabilitations with a cemented prosthesis Intraoral welding of a titanium bar or winged abutments to implants of either groups at the end of the implant placement session stabilizes the implants Subsequently the dentist will place the provisional teeth screwed and or cemented according to the implant system chosen which will enable the patient to chew immediately with some precautions and almost eliminates any inconvenience in social interactions The titanium bar and or wing abutments are essential to perform the immediate load because they preserves the primary stability of the implants a basic condition for osteointegration In fact they provides each implant with an absolute stability The welded bar and or the wing abutments do not just stabilize the implants but also distribute the chewing forces on the whole implant structure This is the reason why bracing of the implants with a welded bar and or wing abutments allow both their immediate loading and their full functionality Immediate functionality accelerates peri implant bone regeneration and improves bone reshaping and thus the osteointegration process secondary stability The intraoral welder designed for welding titanium parts enables the implantologist to build superstructures on implants commonly used thus achieving strength and a well balanced distribution of masticatory loads on them
27. ical and electronic equipment or give it back to his distributor upon buying a new one The proper differentiated waste collection of the disused device followed by its recycling processing and proper disposal helps to avoid negative side effects on environment and health and favors the reuse and or recycle of the materials the device is made of Unauthorized waste disposal of the device by its holder implies administrative sanctions according to the applicable law e For further details please see the law mentioned above Manual code Model Device code Pag 32 DOC MAN DWD rev 100201 DENT WELD PASEOEWDO02 1 D swiss WEGMAN medical equipment CHAPTER 6 PREVENTIVE AND CORRECTIVE MAINTENANCE Upon written request the manufacturer makes available the circuit diagrams and test instructions for those parts of the system that are considered serviceable to enable qualified staff authorized by the manufacturer to repair or test the device Corrective maintenance The manufacturer strongly suggests to prevent improperly trained personnel from repairing the device It is advised to fill in the enclosed form for technical service request and send it to the manufacturer Any user who intends to repair the device on his own assumes all responsibility for any possible damage to device patients operators or any other person Besides it is advised to contact the manufacturer in any case to communicate the intended repair
28. intraoral welding The use of the intraoral welder Dent Weld facilitates dental implantology surgeries by allowing a functional and aesthetic recovery of edentulisms cases that would be incurable with other implant techniques without laborious and unpredictable bone reconstructions often requiring a long time before permanent prostheses can be placed By using the intraoral welder to build structures to brace dental implants such implants reach the best possible primary stability an essential condition to reach osteointegration histologically demonstrated This sound primary stability allows also the immediate placement of temporary prostheses and of permanent prosthesis in predictable times and with reliable results The immediate load method is based on implants specifically designed to hold fixed temporary prostheses immediately after implant placement With immediate loading systems the patient who needs tooth extractions or fixed prostheses can have provisional fixed teeth placed in a single session Traditional implant protocols associated with two stage implants call for a waiting period 4 6 months while the implants are hidden under the gum before the implants are loaded After that period during which removable provisional prostheses are used the dentist has to cut the gum again to complete the implant procedure to place the permanent prosthesis On the contrary cutting the gum again is not necessary with immediate load implant protoco
29. k frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Network frequency magnetic fields should be at levels normal for a typical residential or commercial environment Note UT is the a c network voltage prior to application of the test level Manual code DOC MAN DWD rev 100201 Model Device code DENT WELD PASEOEWDO002 1 Pag 18 E SWISSSWEGMAN medical equipment Electromagnetic immunity Guide and manufacturer s declarations Electromagnetic immunity Dent Weld is intended for use in the electromagnetic environment specified below The customer or the user of the system should assure that it is used in such an environment Immunity test IEC 60601 Compliance Electromagnetic environment Guide test level level Conducted RF 3 Vrms 3V Portable and mobile RF communications equipment should be used no closer to any part of Dent Weld including cables than the recommended separation distance calculated from the equation applicable to the IEC 61000 4 6 150 kHz to frequency of the transmitter 80 MHz Recommended separation distance Radiated RF 3 V m 3 V m d 1 2 VP d 1 2 VP from 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz d 2 3 VP from 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 Fiel
30. l melting If the tongs did not reduce accordingly the distance between electrode tips empty spaces would be created between electrodes and metal In order to continue to flow within the discharge loop the current would form arcs thus causing sparks As previously said such risk is minimized by the tongs capability to constantly apply a strong pressure on the metals even during the welding phase However the operator is well advised to verify that mucous membranes soft tissues or suture threads are not pinched between metals and electrodes Another element to take into consideration is the choice of proper welding parameters Exceedingly high power levels passing through thin metals could cause the whole metal to be melted instead of welded thus resulting in metal splitting and spattering of molten metal pieces within the oral cavity The choice of welding parameters is simplified by using the preset programs However the operator is advised to make some extra oral welding tests to select the most appropriate parameters for the kind of implant and bar used encouraged to make some extra oral welding tests to select the most appropriate setting 1 ATTENTION It is possible to use preset welding parameters but the operator is for the kind of implant and bar and or wing abutment used Manual code Model Device code Pag 12 DOC MAN DWD rev 100201 DENT WELD PASEOEWDOO2 1 D swiss WEGMAN medical equipment
31. lece 5 i eorr aaan ii cri 29 Errors arid Alarms rr Re EET ERR ERE dbl adi s 30 Tong steriliZatiOn coucou Fern A M RD Ue XE a da 31 Important notes on waste diSpOSAl cccoooonccnnncononcnncnnnnnnnnnnnnncnnnnnnnnennnnnnnrrnrrnn nennen nennen nnns 32 Chapter 6 Preventive and corrective maintenance ssesssseseeeeenn 33 Corrective Malta ars o a codes 33 Technical Service ROQUES decicion gei aene ecu A A A A 34 PREVENUVE maintenance IEEE 35 Chapter 7 Technical Features cc cceceeec nett eee rere ee ener eee eee aaa ee sana eee eaaaeeeesanaaies 37 Chapter 8 Liability for defective product cccceceeeeeseeeee eee eee eeeeea eee eee saan eeeesaaaeeeeenaaes 38 Manual code Model Device code Pag 3 DOC_MAN DWD rev 100201 DENT WELD PASEOEWDO002 1 D swiss WEGMAN medical equipment CHAPTER 1 INTRODUCTION Symbols Used Symbol Attention AN This symbol stands for paying careful attention to the text embedded in this panel because it contains important instructions regarding safety Although symbols facilitate the reading of the manual a complete reading is recommended in order to avoid an unsafe or incorrect use of the device Manual code Model Device code Pag 4 DOC_MAN DWD rev 100201 DENT WELD PASEOEWDOO2 1 D swiss WEGMAN medical equiprnent CE Marking compliance with regulations and directives This
32. ls Single stage implant protocols are different Indeed through a minimally invasive surgery a titanium screw is inserted with a post protruding out of the gum in the space that used to be occupied by the Manual code Model Device code Pag 9 DOC_MAN DWD rev 100201 DENT WELD PASEOEWDO002 1 E SWISSSWEGMAN medical equipment tooth root A temporary artificial tooth is applied on the post emerging out of the gum the same place where the permanent tooth will be placed later Single stage implant systems often can adapt to the patient s anatomy better than other systems allowing for the solid placement of implants even in cases of atrophic bone Immediate loading technique implies shorter rehabilitation times as little surgery is performed on mucous and bone tissues thus reducing the healing period Often one single session is sufficient to perform the whole necessary sequence including extractions other oral hygiene procedures and implant placement ending with the placement of temporary fixed teeth After this first session the patient has to wait two to three months for final prostheses to be placed with cement and or screw retained implant restoration methods The most frequently used implant groups for immediate loading are Two piece implants composed of an endosteal part and an abutment screwed to it which allows a rehabilitation using a cemented and or a screwed prosthesis One piece monolithic implants compos
33. ly the following indications The system must be installed and used according to the instructions given in this manual with special consideration for those concerning safety Any operation of modification calibration and maintenance must be carried out by qualified staff authorized by the manufacturer The electrical installation for which the device is intended must be in compliance with both IEC requirements and all local codes The system must be connected to ground The manufacturer the installer and the importer are responsible for safety reliability and efficiency of the device only if all the above mentioned conditions are fulfilled The manufacturer makes available on written request the circuit diagrams and testing instructions for those parts of the system that can be repaired to allow qualified staff authorized by the manufacturer to repair or test the device Manual code Model Device code Pag 7 DOC MAN DWD rev 100201 DENT WELD PASEOEWDOO2 1 D swiss WEGMAN medical equipment Application field Dent Weld is an electrical device for dental use In its normal application by a dentist the handpiece transfers energy in the form of electric power that converts into heat to two parts to be welded within the patient s oral cavity Dent Weld has no therapeutic and or diagnostic effect It is a surgical device to be used in dental implant surgery The application field of Dent Weld is dental surgery Dent
34. ode Pag 1 DOC MAN DWD rev 100201 DENT WELD PASEOEWDO002 1 D swiss WEGMAN medical equipment Position and siz of the Cal cri ii ia 16 ccn E 17 Iul E 18 a eurerser re n nennen a aa ENA 19 E cd ote Q 21 Chapter 5 Mode of USE ccoo ice Rx ER Aaa E n Jo On Eua Reb Rx Ine ko ceca 22 liiis Wr EEEa 22 Place of SG We T 22 DEVICES handling dao A A A a a ERA 23 ee diera ds dar ai e cd 23 Package contents artis er Y cosas ea EiYv sede ne Vv en hh xvii a YR RHNER ES RENE ERE EE ER ERES ES R Ver eua EY Ya Ee RES 23 Subsequent handlirigs tette II Nee RERO E eed Rc 23 Mar tEl MENS erica 24 o o 24 BACK rl da 25 Intraoral A O 25 Pre Operative SEQUE iii A a 26 Arrangement and connection of the DandpieCe ooccccconncncncnonocinnnnonnnnncnnnnnnnncnnanennnrnnnnrrnrnrnnrnnnnnns 26 Installation Of e Molto A Ea ie A E EAT Ea telex 26 Operation Sequence ius id e ic aia do IA 27 PASS WO EE 27 Program seleciona Doe A A id 28 Welding power Modifica ON iS 28 Welding mode modification eios eee or reno rrr a ice 28 Manual code Model Device code Pag 2 DOC MAN DWD rev 100201 DENT WELD PASEOEWDO002 1 D swiss WEGMAN medical equipment Device activation c 28 Positioning the handp
35. rent necessary to weld two metals in this way is provided by a current pulse Two additional important aspects must be taken into consideration the welding surface and the duration of the energy application If energy is supplied on a very small contact surface between metals the energy density defined as energy per surface unity will be very high as a consequence it Manual code Model Device code Pag 8 DOC MAN DWD rev 100201 DENT WELD PASEOEWDO02 1 E SWISSSWEGMAN medical equipment will be possible to localize it on a very small area and produce an important temperature increase The size of the contact surface is not a settable parameter but depends on the shapes of the items to be welded The other parameter to be considered is duration Too long a duration would allow heat to spread within the metals as they are notoriously good conductors The metal volume would increase therefore the temperature necessary to melt metals would not be reached On the other hand too short a current pulse would not allow heat to spread enough within the metals causing a superficial effect and a poor quality weld Therefore the current pulse has been set to last enough time to assure the best possible quality of welding The welder can also produce a reduced current pulse to pre heat the materials before the actual welding current pulse is produced in order to produce high quality welding even with thick metals Benefits of
36. ssories available by separate order HANDPIECE SURGICAL TONGS PAMANPINOO1 1 Manufacturer s Identification The manufacturer responsible for the product is Swiss amp Wegman S r l Via Svezia 8 35020 Ponte San Nicol Padova ITALY Manual code Model Device code Pag 6 DOC MAN DWD rev 100201 DENT WELD PASEOEWDO02 1 D swiss WEGMAN medical equipment CHAPTER 2 SCOPE OF USE Warnings It is recommended that particular attention be paid to reading it and all instructions be followed 1 ATTENTION This paragraph specifically concerns safety instructions Dent Weld is a medical device specifically designed for dental practice It exploits the Joule effect to produce the heat necessary to melt titanium in order to obtain high quality welding directly within the oral cavity Thanks to its high capacity to transfer energy Dent Weld is able to weld very thick surfaces It is possible to set special parameters for welding or simply choose one of the pre set programs The pre installed programs are the results of careful laboratory tests that perfected the parameters able to guarantee the best performance in specific conditions of use The manufacturer is not responsible for any direct or consequential undesirable effect due to misuse of the device Such undesirable effects remain under the direct responsibility of the operator The user is strongly recommended to app
37. t premises will be at the customer s expense including any transport insurance cost Therefore warranty does not cover any shipment and round trip freight charges In case of delivery by mail railway or courier it is recommended to use the original packaging The Customer will be responsible for making sure the goods do not suffer damage during transportation Our warranty does not cover any damage due to transportation No responsibility is accepted nor compensation to customer is provided for any damage or contingency direct or consequential accidental or resulting from lack of use during the time between defect detection and restoration of the device Manual code Model Device code Pag 38 DOC_MAN DWD rev 100201 DENT WELD PASEOEWDO02 1
38. urs turn the device off and turn it on again If the problem persists contact the manufacturer Alarms indicate that the device is being used under conditions not allowed ELECTRICAL ERROR Indicates malfunction of the internal circuit board Switch off the device wait for thirty seconds and turn it on again If the problem persists take note of the error code that follows errore elettrico Contact the manufacturer and reference such code TEMPERATURE ERROR It indicates that the device temperature is not adequate for use Stop using the device and and wait at least 15 minutes before starting to use it again Shouldn t such measures solve the problem please contact the manufacturer ALARM OPEN TONGS If the tongs are open or badly tightened when the welding starts such alarm is produced Be sure that tongs are not open or the contact point between electrodes and metals to be welded is clean Manual code DOC MAN DWD rev 100201 Model Device code Pag 30 DENT WELD PASEOEWDO002 1 D swiss WEGMAN medical equipment Tong sterilization All pieces that may get in contact with the patient s organic parts can and must be sterilized The equipment pieces that can be sterilized are e tongs e electrodes ATTENTION Components requiring sterilization must be always properly separated and prepared by removing any solid organic residue
39. work connection cable to the unit and to a 220 V AC socket Connect the control pedal Turn on the device without connecting the handpiece Enter the password Keep the DOWN key pressed A test on display and on light indicators will start Check that the indicators are working and in good condition During this test all the main displays READY CHECK and ALARM indicators will light up in sequence while the POWER ON indicator of presence of power will be lit up with green throughout all the test Charging indicator will be off When the test is over a beep will sound and the device will turn on normally Select a treatment Press the READY key Press the control pedal The device should show ALLARME PINZA APERTA ALARM OPEN TONGS Manual code Model Device code Pag 35 DOC_MAN DWD rev 100201 DENT WELD PASEOEWDOO2 1 D swiss WEGMAN medical equipment Connect the handpiece equipped with tongs and put it in the rest position with electrodes in contact e Press READY key the system indicates to conclude the welding process without signaling any error e Execute an electrical safety test for CLASS I devices with a BF handpiece Inform manufacturer about any abnormal condition The only elements subject to wear are The power accumulator capacitor must be replaced after 3 years of use e The EEPROM internal memory can perform at most 1 000 000 cycles of writings
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