User Manual
Contents
1. 21 Servicing Repairs If a defect occurs always return the complete S5 Endo Motor due to the fact that with malfunctions an inspection of all components is necessary Returns gt Refer all questions to your authorized service organization see page 33 gt Always return equipment in the original packaging 28 15 Sendoline Accessories Use only original Sendoline accessories spare parts or accessories approved by Sendoline 1100001 1100002 Drive handpiece Contra angle head 1100003 Charging station 1100006 301 Handpiece holder W8 amp H Assistina 1100005 Universal adaptor for maintenance units S 10940021 W amp H Service Oil F1 MD 400 02038200 Spray cap with nozzle for contra angle handpieces 1100004 Rechargeable battery Li lon 3 7 V 29 16 Technical data Drive handpiece EB 3SH rechargeable battery type mains voltage rated capacity rotational speed on root canal instrument dimensions WxDxH weight Charging station mains voltage allowable voltage fluctuation frequency rated current power dimensions WxDxH weight Li lon 3 7 V 680 mAh 300 rpm setting I max 4 0 Ncm setting 2 max 3 0 Ncm setting 3 max 2 3 Ncm setting 4 max 1 2 Ncm setting 5 max 0 5 Ncm 140 x 28 x 26 mm 85g 100 240 V 10 50 60 Hz 0 08 0 12 A2. Charging station Description Remedy Charging control LED charge flashes orange Remove and reinsert the drive handpiece Check that the mains cable is plugged in and that the No LED illuminates power switch is set to ON I If one of the error messages described above cannot be rectified by remedy the equipment must be checked by a service and repair organization authorized by Sendoline see Page 33 26 14 Servicing A Regular checking of the S5 Endo Motor Regular testing of function and safety is necessary and should be carried out at least once every three years unless shorter intervals are prescribed by law The inspection must be undertaken by a qualified organization and needs to include the following procedures Charging station gt visual inspection for outside damage gt measurement of housing leakage current gt visual inspection of internal components and electronic boards on suspicion of safety interference e g mechanical damage of the enclosure or indicators for overheated or burned electronic components Drive handpiece gt visual inspection for outside damage gt visual inspection of internal components and electronic boards on suspicion of safety interference e g mechanical damage of the enclosure or indicators for overheated or burned electronic components We recommend that this inspection is only carried out by an authorized service organization See page 33
3. Test run gt Insert root canal instrument gt Start the drive handpiece gt If you observe problems e g vibrations unusual noise or excessive heating stop operation of the drive handpiece immediately and contact an authorized service organization see page 33 15 9 Operating Adjust torque Adjust the torque Start or stop the drive Ker Preset torque is handpiece with the button characterized by the motor ON OFF illuminated LEDs am If you press the motor ON OFF button for more than approx 1 second the drive handpiece will stop auto matically when you let go Kee gt For information about the torques to be set see the attached torque overview or sendoline com gt The torque can only be set when the drive handpiece is stationary gt The last torque setting is saved gt The drive handpiece switches off after it has been idle for 4 minutes gt When the battery capacity display begins to flash a minimum of one more application is possible After this appears Sendoline recommends that the battery should be recharged immediately as otherwise it cannot be ensured that the torque values will be achieved Adjusting torque sequence from low to high torque Press the torque settings button for approx 10 seconds Ker The middle 3 LEDs flash after 5 seconds The change in torque sequence is saved when the 2 outer LEDs flash T To change the factory set torque s
4. KP Sendoline recommends processing in a thermo washer disinfector Follow the manufacturer s recommendations for devices and cleaning agents Lubricate contra angle head immediately after thermo washer disinfection Daily oil service with W amp H Service Oil F1 MD 400 gt Follow the instructions for use of the oil Spray can 23 Hygienic maintenance Daily oil service service with W amp H Assistina gt See instructions for use of Assistina Push the universal adaptor onto the contra angle head Assemble remove the appropriate adaptor onto the maintenance attachment of the Assistina Push the button and remove the universal adaptor from the contra angle head Recommended lubrication cycles W amp H Service Oil F1 und Assistina gt Essential after internal cleaning gt Before each sterilization or gt After 30 minutes of use or gt At least once daily Test run following oil service Push the contra angle head onto the drive handpiece Place the contra angle head with head downwards Run the drive handpiece for 30 seconds to remove excess oil gt Repeat the entire hygienic maintenance process if dirt emerges Wipe the contra angle head and the drive handpiece with gauze or a soft cloth 24 Hygienic maintenance Sterilization and storage F amp F Sendoline recommends sterilization according to EN 13060 class B gt Note the instructions of the unit manufacturer gt Clean
5. All packaging materials have been selected according to environmental compatibility and disposal aspects and can be recycled Please send old packaging materials to the relevant collection and reprocessing system In this way you will contribute to the recycling of raw materials and the avoidance of waste 32 Sendoline Contacts SED Sendoline AB Box 7037 Tillverkarvagen 6 SE 187 11 Taby Sweden Phone 46 0 8 445 88 30 Fax 46 0 8 445 88 33 E mail info sendoline com 33 Letter of indemnity This Sendoline product has been manufactured with great care by highly qualified specialists A wide variety of tests and controls guarantee faultless operation Please note that claims under warranty can only be validated when all the directions in the Instructions for Use have been followed As manufacturer Sendoline is liable for material or manufacturing defects within a warranty period of 12 months from the date of purchase for the drive handpiece contra angle head charging station and the rechargeable battery Li lon 3 7 V We accept no responsibility for damage caused by incorrect handling or by repairs carried out by third parties not authorized to do so by Sendoline Claims under warranty accompanied by proof or purchase must be sent to the vendor or to an authorized Sendoline service point The provision of service under warranty extends neither the warranty period nor any other guarantee period 12 Months Warranty Manufa
6. 12 6 Starting operation Charging station Place the drive handpiece in the charging station Cam Note the positioning All the drive handpiece LEDs light up briefly Oh Connect the mains cable Turn on power switch Rechargeable battery is F The green control LED charging power Comes on FT Orange charging MA control LED charge Ee L SA comes on Cam gt The drive handpiece can remain in the switched on charging station until it is next needed gt Fully charge the battery prior to initial use This process takes approx 100 minutes gt The rechargeable battery is fully charged when the orange LED goes out 13 7 Starting operation Assembly removal of the contra angle head Only change the contra angle head when the drive handpiece is stationary Push on the contra angle head by applying slight axial pressure position selectable Remove the contra angle head by applying slight axial tension 14 8 Changing the root canal instrument Only change the root canal instrument when the drive handpiece is at a complete standstill Push in the root canal Remove the root canal instrument as far as the We instrument by pushing the locating lug a and turn JA press button JA Xx m until it engages b ei Check secure location by applying slight axial EZ tension NA
7. 5 W 95 x 159 x 65 mm 345 g 30 Technical data Contra angle head EB 16S transmission ratio coupling typ recommended root canal instrumente Instrument shaft diameter type 1 in accordance with EN ISO 1797 1 1995 min chuck length weight 16 1 Sendoline coupling files for rotating root canal preparation for min 300 rom 2 35 mm engaging 35 g In choosing the correct operating conditions the user must ensure that there is no risk to the user the patient or third parties Always follow the instructions of the manufacturer of the root canal instruments e g in terms of speed torque described application Physical characteristics Temperature in storage Air humidity in storage Temperature in operation Air humidity in operation 40 C 40 F to 70 C 158 F 8 to 80 relative non condensing at 40 C 104 F 10 C 50 F to 40 C 104 F 15 to 80 relative non condensing at 40 C 104 F 31 Technical data Recycling Sendoline considers that it has a special duty towards the environment The S5 Endo Motor along with its packaging has been designed to be as environmentally friendly as possible Disposal of the S5 Endo Motor charging station drive handpiece rechargeable battery contra angle head Follow your country specific laws directives standards and guidelines for the disposal of used electrical devices Disposal of the packaging material
8. 7 V in the condition as delivered by us This declaration is not valid for unintended external or internal attachments and similar Sendoline AB in T by Sweden can only accept responsibility for the safety reliability and performance of the S5 Endo Motor when there is compliance with the following directions gt The S5 Endo Motor must be used in accordance with these Instructions for Use gt The S5 Endo Motor contains no parts which are repairable by the user Assembly modifications or repairs must be carried out only by an authorized service organisation see page 33 gt The electrical installation at the premises must comply with the international regulations of IEC 60364 7 710 Electrical installations of buildings Part 7 710 Requirements for special installations or locations Medical locations or with the regulations applicable in your country Responsibility of the manufacturer HF Communication Devices During operation please do not use any portable or mobile high frequency communication devices such as mobile telephones These can have a negative effect on electrical medical devices 2 Equipment supplied After unpacking the following parts should be present REF 1100010 O drive handpiece REF 1100001 O contra angle head REF 1100002 O charging station REF 1100003 O rechargeable battery Li lon 3 7 V REF 1100004 O mains cable REF 05464400 Europe alternative specification O mains cable REF 05
9. and drive handpiece may be wiped clean gt For disinfection with surface disinfectants wiping disinfection is recommended gt Use only surface disinfectants which do not contain chlorine and which are certified by officially recognized institutes For USA Use EPA registered surface disinfectants gt Note the manufacturer s specifications for the use of the surface disinfectants 21 Hygienic maintenance contra angle head Pre disinfection gt If heavily soiled Clean first with disinfectant cloths T Only use disinfectants that have no protein fixing effects Manual cleaning internal and external Rinse under demineralized water lt 38 C with the aid of a brush brushing under running water is not recommended in U K Then remove any liquid residues absorbent cloth blow dry with compressed air Manual disinfection gt Disinfection with surface disinfectants wiping disinfection is recommended gt Use only surface disinfectants which do not contain chlorine and which are certified by officially recognized institutes For USA Use EPA registered surface disinfectants gt Note the manufacturer s specifications for the use of the surface disinfectants After manual cleaning disinfection and lubrication you must carry out a final sterilization wrapped in a class B or S steam sterilizer according to EN 13060 Se Hygienic maintenance Mechanical cleaning and disinfection
10. 456100 USA CAN J REF 05457700 UK IRL REF 05467600 AUS NZ 3 Safety notes A A A It is essential to comply with the following instructions gt Always ensure the correct operating conditions gt Perform a test run prior to each use gt Only use REF 1100002 Sendoline contra angle head gt Only insert the contra angle head when the drive handpiece is stationary gt Check the contra angle head for damage and loose parts prior to use e g press button gt Never touch the press button of the contra angle head during use or while slowing down This can cause loosening of the root canal instrument or the press button to become hot gt Avoid contact between the instrument head and soft tissue danger of burning due to the press button heating Up gt Use only perfect root canal instruments and follow the manufacturer s instructions gt Only insert the root canal instrument when the contra angle head is stationary gt Never touch root canal instruments while running or slowing down gt The drive handpiece should only be placed in the holder as it may heat up Do not place it on the patient s body gt Sendoline recommends the use of rubber dam gt Store drive handpiece and charging station for 24 hours at room temperature before starting operation Hygienic maintenance prior to initial use The items are in a clean condition when delivered gt Sterilize and lubricate the contra angle head gt d
11. Sendoline Instructions for use of S5 Endo Motor Sendoline Symbols A A e WARNING ATTENTION General explanations Risk of injury to prevent damage occurring without risk to persons or objects 135C T 555 Thermo washer disinfectable Sterilizable up to the stated temperature Sendoline Service Only for USA Caution Federal law restricts this device to sale by or on the order of a dentist physician or any other practitioner licensed by the law of the state in which he or she practices to use or order the use of the device Sendoline Symbols Symbols on rechargeable battery charging station contra angle head drive handpiece pH Consult Instructions for use X Do not dispose of in general REF Catalogue number waste E SN Serial number V Supply voltage Class II equipment i Data Matrix Code electric insulating for product identification e g AC Alternating current in hygienic maintenance Process W Electric power input of the unit Date of manufacture este Classification mark A Supply current iv d that this product is in compliance with the Hz Frequency of the alternating American and Canadian current SSES rom Revolutions per minute A Not suitable for intracardiac application Type BF mAh Milliampere hours appliance Ncm Newton centimetres Contents ele eine EE 2 1 194 2050 Eed Le EE 5 2 F L PMENESUPPIG OG WE T EE e 8 10 4 Description Charging station EE 11 5 De
12. cturer Sendoline AB Box 7037 Tillverkarv gen 6 SE 187 11 T by Sweden t 46 0 8 445 88 30 f 46 0 8 445 88 33 e info sendoline com sendoline com ISO 13485 93 42 EEC Annex II Form Nr 50632 AEN Rev 002 12 10 2009 Subject to alterations
13. disinfect and lubricate before sterilizing gt Wrap the contra angle head in sterile goods packing according to EN 868 5 gt Make sure that you only remove dry sterile goods gt Store sterile goods dust free and dry Approved sterilization procedures Ke Follow your country specific directives standards and guidelines gt Steam sterilization class B with sterilizers in accordance with EN 13060 Sterilization holding time a minimum of 3 minutes at 134 C 273 2 F or gt Steam sterilization class S with sterilizers in accordance with EN 13060 The manufacturer must give their express approval for the sterilization of contra angles Sterilization holding time a minimum of 3 minutes at 134 C 273 2 F 25 13 Description of failure Remedy Drive handpiece Description Remedy The drive handpiece cannot be activated The rechargeable battery is empty Charge or change it Restore factory settings press and hold the torque settings button for approx 15 seconds After the first 5 seconds the middle 3 LEDs flash after a further 5 seconds the 2 outer LEDs flash and after a further 5 seconds only the middle LED continues to flash this indicates that the factory settings have been restored Internal error all 5 LEDs on the torque display are flashing System failure Disconnect Connect the rechargeable battery The rechargeable battery heats up excessively Change the rechargeable battery
14. equence again from high to low torque repeat this process 16 10 Operating Auto Forward and Auto Reverse mode The factory setting is Auto Forward mode If the preset torque is reached the drive handpiece continues running in an anti clockwise direction so that the root canal instrument becomes free and then it runs in a clockwise direction If the preset torque is reached the drive handpiece continues running in an anti clockwise direction so that the root canal instrument becomes free and then it stops 17 Operating Auto Forward and Auto Reverse mode T If more than 75 of the preset torque is reached the control LED ring for torque lights up Conversion to Auto Reverse mode Press the torque settings button for approx 5 seconds When the middle 3 LEDs flash the mode change is saved T The last torque set is retained T Repeat the procedure in order to change back to the Auto Forward mode Restore factory settings Press and hold the torque settings button for approx 15 seconds The LEDs flash in a particular sequence see page 26 and afterwards the factory setting has been restored 18 11 Exchanging the rechargeable battery T Replace the battery if power fails relatively quickly after a full charge A In order to avoid damaging the device one should avoid opening the battery cover unnecessarily Take the cover off Ins
15. ert the new rechargeable battery Connect the plug contacts Kee Note the positioning Close the cover Cn Note the positioning Disconnect the plug contacts Take the rechargeable battery out 19 12 Hygienic maintenance CS A Follow your country specific directives standards and guidelines for cleaning disinfection and sterilization gt Wear protective clothing Remove the root canal instrument gt Remove the contra angle head from the drive handpiece V gt Clean and disinfect the contra angle head immediately after every treatment to rinse out any liquids that may have entered e g blood saliva etc and prevent seizing up of the internal parts gt Clean and disinfect the drive handpiece immediately after every treatment gt Sterilize the contra angle head following manual or mechanical cleaning disinfection and lubrication gt The charging station and drive handpiece are not approved for mechanical cleaning thermo washer disinfection and sterilisation 20 Hygienic maintenance Charging station and drive handpiece N gt The mains cable of the charging station must not be connected gt Do not submerge the drive handpiece and the charging station or clean them under running water Pre disinfection gt If heavily soiled Clean first with disinfectant cloths Manual cleaning and disinfection T The surface of the charging station
16. harging station for mechanical preparation of the root canal The application area extends to endodontic procedures using a special root canal instrument which is intended by the manufacturer for use in the mechanical and rotary preparation of the root canal Misuse can damage the S5 Endo Motor and involves risk and danger to the user and third parties User qualifications In the development and design of the S5 Endo Motor we have assumed the target group of users to be dentists Skilled application This medical product is intended only for informed use in the medical dental field according to its purpose of use in compliance with the valid health and safety at work regulations the valid accident prevention regulations as well as in compliance with these Instructions for Use The S5 Endo Motor should be maintained according to the manufacturer s recommendations and in line with infection control procedures for the safety and well being of patients Improper use e g poor hygienic maintenance or non compliance with our Instructions or the use of accessories and spare parts which are not approved by Sendoline invalidates all claims under warranty and any other claims Introduction C Production according to EU directive This medical product has been designed and manufactured according to EU Directive 93 42 EEC 0413 and is valid for the gt 5 Endo Motor charging station drive handpiece contra angle head and rechargeable battery Li lon 3
17. isinfect the drive handpiece and charging station prior to initial use see page 20 25 Inappropriate use Improper use in addition to incorrect assembly installation modification or repairs of the S5 Endo Motor or non compliance with our instructions invalidates all claims under warranty and any other claims 8 Safety notes gt The rechargeable battery Li lon 3 7 V is not sterilizable gt Only use REF 1100004 Sendoline rechargeable batterys Using a different model of battery can cause a fire or explosion gt Only use the Sendoline rechargeable battery REF 1100004 in connection with the Sendoline drive handpiece REF 1100001 and the battery charging station REF 1100003 gt The rechargable battery used in the device can cause a risk of fire or acid burns if it is not used properly e g charging in a charging station other than the one provided gt The battery may not be dismantled heated to above 100 C 212 F or burned gt Defective or disused rechargeable batteries must be immediately disposed of in the correct manner gt Keep the rechargeable battery out of the reach of children It is essential to comply with the following instructions when using the rechargeable battery The S5 Endo Motor charging station drive handpiece The unit is classed as conventional equipment closed equipment without protection against the ingress of water System failure A total system failure of the S5 Endo Motor does not cons
18. scription Drive handpiece Rechargeable battery Contra angle head A 12 Ge Staring operation Charging Statii DE 13 7 Starting operation Inserting removing contra angle head mnsesesssssresrrrsrrrsrrrrrrrrrrrrrrrr ran rrrrr rr rr rr KKR KKR KKR RR KR KKR RR SRA Kan 14 6 Changing he TOC Canal in E dE 15 I et ae SESE rer RTE 16 10 Operating Auto Forward and Auto Reverse mode sunssmesrrssrrsrrrsrarsrrsrrrrrrrnrrrrr rss rank rr RAR RKA KKR RR KRA RKS RR RR KKR R RAR nn 17 18 11 Changing the rechargeable battery un 19 12 Hygiene mantenanCeE ssctesatetssactse state tucsetoneiden a bir ss is Os d r se see RUN DK ERS RER NE KK br Eb R RANE KE FN 20 25 13 Descriplon of Tare e EE 26 TA FE lee e BEE 21 28 Eeler ee e 29 Io Teme E e e ME 30 32 SEMOOMME CONACIS asben epea EE E NEEE EEES E AEEA EIE TOERE E RETES E isl scoenetaasccimeudsananedelanadun IRENE 33 Lenor OF maorin liy E 34 1 Introduction These instructions explain to you how to handle your Sendoline product However we must also warn against possible hazardous situations Your safety the safety of your team and of course the safety of your patients is of paramount importance to us f For your safety and the safety of your patients A N It is therefore essential to read the safety notes on pages 8 to 10 Intended use The Sendoline S5 Endo Motor is a modular electrical system comprising a drive handpiece a rechargeable battery a contra angle head and a c
19. titute a critical fault The charging station has been adjusted to fit the Sendoline drive handpiece The use of other charging stations drive handpieces could lead to irregularities or destruction of the electronic system rechargeable battery atmospheres or in potentially explosive mixtures of anesthetics with air oxygen or nitrous oxide or at locations According to IEC 60601 1 UL 60601 1 the S5 Endo Motor must not be used in potentially explosive where concentrations of such gases could occur closed rooms Safety notes The patient zone see diagram represents an area of 2 50 m above and 1 83 m around the patient Do not use the charging station in the patient zone n E M E ES T i Sy a 10 4 Description Charging station charging slot for drive handpiece control LED power 0 ON green S charging control LED charge orange power socket power switch ON OFF I 0 11 5 Description Drive handpiece Rechargeable battery Contra angle head Sendoline coupling for contra angle head a gt button for unit ON and motor ON OFF control LED ring for torque torque display setting 1 4 Ncm max 2400 gem button for unit ON and torque settings rechargeable battery Capacity display charging contacts rechargeable battery cover press button plug contact into drive handpiece
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