KaVo Surgery Portfolio Current Questions and Answers

Transcription

1 Current Questions and Answers 1

2 The perfect fit for your daily challenges Operate safely with high precision Rely on high performance Save time with easy-to-use features 2

3 1.Questions regarding Technical Service 3

4 Who is able to carry out the repeated inspection (technical safety check / TSC) and when? This check may only be carried out by an electrician who has received appropriate training for the medical product by KaVo. This check is required by law and has to be conducted for the EXPERTsurg and MASTERsurg every two years. The contents and given tests are based on the international standard IEC This standard applies worldwide for tests of medical electric devices or medical electric systems based on IEC

5 Who is able to conduct the KaVo service check and when? The service check is conducted directly by the regional KaVo Service Organization. (Please contact the regional KaVo Service Center listed on the service Flyer shipped with the product) The service check of the EXPERTsurg and MASTERsurg should be conducted every 2 years according to the technical instruction. Content of the KaVo service check: Check of the functionality Update of the software Calibration and check of the performance Repeated inspection (TSC) Thus the dentist is always on the safe side at a fair fixed price. 5

6 What does the Service Check Icon at the Display mean? EXPERTsurg requires every 2 years a service check: Even if the last date (red wrench) is exceeded, the device works without limitations! 6

7 Are loaner units for bridging time of repairs or device checking available? Yes. If required KaVo is offering a loaner units to bridge time a device has been sent in for repair or service check. Please contact the regional KaVo Service Organization listed on the Service Flyer shipped with the product. 7

8 Which warranty offers KaVo for the EXPERTsurg and MASTERsurg and the SURGmatic instruments? KaVo offers a warranty of one year. 8

9 Current Questions and Answers How to conduct a software update? Download the software from KaVo Homepage. Save the Software on a SD card (1-32 GB in FAT) Turn off the device Insert the SD card with the new firmware file into the unit. Make sure that only a single firmware file with the.bin file extension (the downloaded current file) is stor ed on the SD card. Turn on the device Update will be started automatically. After the update the device is ready with the new software Info: After the update the filename of the software file is renamed from.bin to.old 9

10 2.Questions regarding Instruments 10

11 Which instruments can be checked with the One Touch Calibration? All instruments of the SURGmatic S201 line as well as INTRA LUX contra-angles with a reduction ratio of 27:1 (CL3-09; C9/C3) and 16:1 (3624 N und 67 RIC) can be checked. 11

12 One Touch Auto Kalibrierung 1. Only Contra-angles. 2. Compare transmission of the used handpiece with the display. 3. Press the button. 4. Follow the display. The auto calibration thus provides for a more accurate torque on the contra-angle handpiece. 12

13 Can the SURGmatic instruments be reprocessed according to RKI requirements? KaVo SURGmatic instruments fulfill the strict German RKI-requirements through a proven reprocessing. The effectiveness of the procedure (see user manual) is approved by tests of an accredited hygiene institute. The instruments should be reprocessed in assembled condition, as it corresponds to the validated reprocessing process (see user manual). The instrument can be disassembled in head and shank for manual non-fixing* pre-cleaning. *non fixing: no alcohols, no aldehydes 13

14 Are the new SURGmatic instruments compatible with the INTRAsurg surgery devices or devices of other manufacturers? Yes. But the function for the automatic detection of the instrument can not be used on the KaVo INTRASurg

15 Are the previous KaVo surgery instruments compatible with the new Surgery devices? Yes. If the instruments have the following transmissions: 1:1 / 16:1 / 20:1 / 27:1 15

16 Are the heads of the INTRAsurg line (e.g. CL 3, C 3 and 67 RIC) compatible with the new SURGmatic S201 shanks? No, see table with examples Shank Head Effect Picture S201 CL 3 gap + no spray clip S201 C 3 no fixation 16

17 Are the heads of the new SURGmatic S201 line compatible with the INTRAsurg shanks (CL 04, CL09, 3620N, etc.)? No, see table with examples Shank Head Effect Picture C 09 S 201 head CL 04 S 201 head Big gap 2 spray clips 17

18 Why are the heads not sold separately? Offering complete instruments to the user facilitates choosing the right product. This prevents complex training in different, mostly special possible combinations. The surgical contra angle S201 series covers all relevant speed and torque ranges. Changing heads is not necessary anymore. Of course all heads are available as spare parts. 18

19 Are the heads with HEXAGON clamping system compatible to shanks S201 L or S201 C (contra-angles without HEXAGON)? No, because for this combination no validation concerning function and reprocessing exists. 19

20 Current Questions and Answers Are my previous drills and inserting tools without HEXAGON shanks compatible with the HEXAGON clamping system? Yes. But the advantages of the optimized torque transmission and durability of instruments and tools cannot be used. 20

21 Which maximum torque can be reached at the tool? The devices including the motor INTRA LUX S600 LED generate a torque up to 80 Ncm at the instrument. As the SURGmatic contra-angles are only approved to a maximum torque of 55 Ncm, torques over 55 Ncm should be avoided with these instruments. Torques over 55 Ncm are clinically irrelevant and therefore rarely used. 21

22 What is the weight of instruments? The weight of the S201 instrument is without bur or external spray clip only 81 g. Therefore they are comparable with the proven KaVo instruments CL03-09 etc. 22

23 3.Questions regarding the INTRA LUX S600 LED 23

24 Is the motor tested and released for the prior program (sterilization with 18 minutes holding time)? Number of reprocessing cycles far exceed the standard requirement - even when using the challenging prion program. 24

25 What happens if there s an error display during the motor calibration/checking of instruments? If an error is displayed, the user should first do a calibration process without instrument. If there s no further error displayed the instrument is worn. use another instrument. If there is also without the instrument an error displayed, the motor is the reason. The case that a magnet got stronger and therefore produces a higher torque is physical not possible. If the magnet becomes weaker the torque goes down. 25

26 KaVo Suregery Portfolio What has to be considered during the change of the Mini LED of the motor? Proceed as follows: Separate motor from cable Remove ring by twisting Push out the old LED with a tweezers Insert the new LED in the slot, with the KaVo logo pointing outward Attach the ring by twisting Test the LED by starting the motor There have to be no special measures concerning electrostatic discharge. 26

27 4. Questions regarding the devices in general 27

28 What can be adjusted at the foot control with the blue closure head? EXPERTsurg: The slot under the lid has no function MASTERsurg: The slot contains the batteries (Alkaline AA) In general: The lid must be closed during the cleaning in order to prevent the penetration of water. 28

29 How long lasts the battery in the foot control of MASTERsurg? It depends how often you use the device. But normally over 3 months. After some minutes the foot control changes in a sleep mode to save energy. Activation by pressing of the foot pedal. Before battery is empty a warning message appears. Once after turning on the device: You should prepare new batteries. Repeated after 10 minutes: You have to change the battery now. 29

30 Saving / recording of data? EXPERTsurg: Saving / recording of data / parameters during a treatment is not provided. Exception: maximum reached torque is displayed until the motor starts again. This can be manually documented. The SD-card slot is only used for software updates. MASTERsurg: Recording of the data while inserting the implant is possible as well as a continuous recording of all device data A.bmp and.csv file is stored on the SD card 30

31 The torque graph at the display doesn t appear. What is wrong? Is the documentation mode turned on in the device settings? Implant must be activated. The program step / activity Inserting implant must be activated. The graph only appears if there is a torque at the instrument. 31

32 What is documented within the.bmp file? Date Entert Position Name of the Program Settings at the end of the record Torque over the time Device Signature 32

33 When is the.bmp and.csv file stored? After 60 Seconds if there is no further activity After changing the Program step After changing the implant position 33

34 Which adjustments are possible? Values can ONLY be edited within the predefined range of the dedicated icons! 34

35 Which parts of the tubing can be sterilized and which cannot? The complete tubing for the irrigation medium is just for single use and must be thrown away after every patient. This leads to higher patient safety, longer lifetime and better flexibility of the motor tube. The motor tube as well as the motor can be thermally disinfected and sterilized. 35

36 Disinfection of housing surface All device surfaces can be disinfected with wipe disinfection. Material test and approval was carried out with following medium: FD 322 Dürr Microcide AF Liquid (Schülke & Mayr) 36

37 Is it possible to use the device in potentially explosive atmospheres? No, the device must not be used in potentially explosive atmospheres. Furthermore the device must not be used in oxygen enriched areas (see instruction of use). 37

38 4. General Trouble Shooting 38

39 - Pump symbol shows yellow background spray-hose is not connected -Display does not match with reality pre-selected tranission is wrong 39

40 - Motor symbol shows yellow background Motor is not connected, defect motor tube or motor -Auto calibration fails Defect contra-angles or motor 40

41 - I can t preselect my request speed. -> Limitation by pre-selected icon - Warning E 42 or E 47 Hardware failure -> Moisture inside the plug of the motor hose 41

42 Non-functional device The unit is switched off. - Switch-on the mains switch on the rear of the unit. Neither end of the power cable is plugged in. - Plug in the power input cable. Unknown - Turn the unit off and on. Blown fuse. - Contact customer service. 42

43 No coolant in the hand piece. The coolant flow pre-selec ted. Pump is off. - Pre-select coolant flow. Hose fixation is not plug ged in. - Plug in the hose fixation. Bottle is empty. - Connect new bottle. Hose clamp is closed. - Open the hose clamp. 43

44 No coolant in the hand piece. Pump locking mechanism is not closed. - Check and close, if needed, the closing mechanism Hose is kinked. - Check hose and remove the kink, if any. Glass bottle containing the coolant is not ventilated. - Open the cap on the ventilation valve of the puncture needle. 44

45 Insufficient coolant flow in the instrument. Spray nozzles are crusty or soiled. - Clean the spray nozzles with the nozzle needle or reprocess the part. Glass bottle containing the coolant is not ventilated - Open the cap on the ventilation valve of the puncture needle. 45

46 The motor makes a grinding noise or does not run smoothly. The motor is not correctly plugged on or screwed on. - Firmly insert the motor hose into the housing. - Firmly screw on the motor hose to the motor. - Check if all the connections and couplings are firmly seated. 46

47 No light on the straight or contra-angle handpiece. The light is not turned on. - Turn on the light. The straight and contra-angle handpiece is improperly attached. - Attach the straight and contra-angle handpiece until the catch audibly locks. Defective LED. - Replace the LED. Not a suitable straight and contra-angle handpiece. - Use a suitable light, straight and contra-angle handpiece. 47

48 Error messages from software Event E3: Release the foot pedal Foot control was activated while the unit started up. - Release the foot control. Event E4: Data initialisation Setting data newly initialised - Confirm message and check or correct the program settings. If the problem persists, notify service engineer Event E6: Internal communication error Internal system error. - Turn the unit off and on. If the problem persists, notify service engineer. 48

49 Error messages from software Event E9: Setting the time and date Time was not reset after re-start. - Setting the date and time. - If the problem persists, have a service engineer replace the battery of the real-time clock. Event E29: SD card write protection SD memory card is write-protected or defective. - Switch the write-protect switch on the left side of the card upwards to "unlock", "write" or the like. - If the problem persists, use a new SD memory card. - If the problem persists, notify service engineer. 49

50 Error messages from software All events >30: Hardware error Internal system error. - Turn the unit off and on. If the problem persists, notify service engineer. Events E36 and E37: Motor overload Overtemperature on stator. Over-current > nominal current. - Let the motor rest. If the problem persists, notify service engineer. 50

51 Error messages from software Event E47 Residual moisture in the plug of the motor cable can lead to false recognition of an E47 error during the startup test of the device. - Turn the device off. - Disconnect the motor cable from the device. - Turn the device on. - Connect the motor cable. - Make sure that water cable and motor plug are absolutely dry. - Do not drive with compressed air as this may drive liquid into the plug. - If the problem persists, notify service engineer. 51

52 Error messages from software Foot control symbol has a yellow background Foot control malfunction. - Check if the foot control plug is plugged in. - Check if the foot control is installed correctly. - If the problem persists, notify service engineer. Motor symbol has a yellow background. No motor attached. - Connect the motor. Pump symbol has a yellow background. Hose fixation is not plugged in. - Plug in the coolant hose. 52

53 Error messages from software One-touch calibration failed. Straight or contra-angle handpiece is too sluggish. - Perform a run in the absence of the straight or contra-angle handpiece. - If no error message is displayed, the handpiece runs too sluggish. - Use a different straight or contra-angle handpiece. If the run in the absence of the straight or contra-angle handpiece again produces an error message, the motor torque is too low. - Use a different motor; possibly return the motor for repair. 53

54 Error messages from software Service symbol is green Service is due soon. - Arrange a precautionary appointment at a KaVo subsidiary or with a KaVo authorised dealer. Service symbol is yellow Service period is expired. - Arrange an appointment at a KaVo subsidiary or with a KaVo authorised dealer. Service symbol is red Service overdue: > 4 months - Arrange an appointment immediately at a KaVo subsidiary or with a KaVo authorised dealer. 54

55 Error message from software Error message "SD card defective" during software update SD card is formatted incorrectly or SD card is defective. - Format SD card in FAT16 or FAT32 format or use new CD card. Then repeat the updating process. 55