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Woodpecker DTE Implant-X, Инструкция по эксплуатации, Страница: 3 / 34

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Contents

1. Product introduction

 ........................................................................................................1

2. Accessories description

 ...................................................................................................3

3. Control of host and foot pedal 

 .......................................................................................4

4. Installation 

 ......................................................................................................................7

5. Operation 

 ......................................................................................................................

10

6. Clean, disinfection, and sterilization 

 ............................................................................

19

7. Error code and solution (error alarm interface)

 ............................................................21

8. Storage and maintenance 

 .............................................................................................21

9. Symbols

.........................................................................................................................23

10. Specifications

 ..............................................................................................................24

11. After-sales service

 .......................................................................................................

25

12. Environment protection 

 .............................................................................................

25

13. Statement 

 ....................................................................................................................

25

14. Guarantee

 ....................................................................................................................

25

15. EMC-Declaration of comformity

 ................................................................................

26

Содержание DTE Implant-X

Страница 1: ...nt Co Ltd Woodpecker reserves the right to change the design of the equipment the technique fittings instruction manual and the content of the original packing list at any time without further notice The product were authorized appearance patent counterfeit will be sued Guilin Woodpecker Medical Instrument Co Ltd ...

Страница 2: ...of safety application in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide Equipment cannot be used in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide 6 Operating mode Continuous operation Precautions 1 Please read these precautions before operation and operate in correct way 2 The following icons is for ensuring safe operation preventi...

Страница 3: ...allation 7 5 Operation 10 6 Clean disinfection and sterilization 19 7 Error code and solution error alarm interface 21 8 Storage and maintenance 21 9 Symbols 23 10 Specifications 24 11 After sales service 25 12 Environment protection 25 13 Statement 25 14 Guarantee 25 15 EMC Declaration of comformity 26 ...

Страница 4: ... device to make it difficult to operate the disconnection device 4 Implant X requires special precautions for EMC and needs to be installed and put into service according to the EMC environment 5 Device with electromagnetic launcher will affect the normal operation of Implant X do not run both devices at the same time 6 Implant X cannot be used in operating rooms containing potentially flammable g...

Страница 5: ...n with the method of disposing medical waste 11 The operation mode of Implant X is continuous operation mode i e there will be 10 minutes pause after 3 minutes operation If there is no system overheating it will prevent the patients users or the third party from hurt The user should be responsible for the use and shutdown of system This instruction manual is intended to indicate the safety require...

Страница 6: ...ocrine system should be cautious to use this equipment 8 Pregnant women lactating women and women have a plan of birth should be cautious to use this equipment 1 3 Scope of use This product is intended for use in dental surgery thus other uses are not allowed There will be potential danger if it is used for other purposes 1 4 Safety requirement Guilin Woodpecker Medical Instrument Co Ltd will NOT ...

Страница 7: ...4 3 Control of host and foot pedal 3 1 Control of host keys 3 1 1 Working interface and control of keys ...

Страница 8: ...d hold to accelerate the speed change 7 Speed control key Used to set rotating speed of motor for speed up while for slow down Press and hold to accelerate the speed change 8 Program key Touch the icons to choose corresponding programs Please refer to the Clause 5 1 for the functions of each program 3 1 2 Interface of restoring the factory settings Whether to restore the factory settings Yes No Fi...

Страница 9: ...ace As shown in Figure 3 the warning 0x indicates alarm number Please refer to section 7 Error code and solution for specific number and the corresponding content 3 2 Foot pedal control 1 Water volume adjustment button Used for choosing 6 cooling water flow levels The water level is incremented each time the button is stepped At the maximum ...

Страница 10: ...ring installation Danger Equipment is installed on the premise that the installation must meet the appropriate standards and related electrical safety requirements Danger Never install the device in an explosion hazardous area and the device must not be operated in areas with flammable gases anesthetic mixture oxygen etc Danger Installation site should be able to protect device from shocks and spl...

Страница 11: ...the device Figure 4 D 4 2 3 Installation of infusion bottle holder Insert the infusion bottle holder into the fixing hole on the right rear of the shell Figure 4 A 4 2 4 Installation of infusion bottle Hang the infusion bottle The infusion bottle contains purchased normal saline injection on its holder 4 2 5 Installation of motor Plug the tail cord of motor into the output socket on the front of t...

Страница 12: ...the peristaltic pump knob clockwise to the CLOSE position and close the pump head Figure 5 D 4 2 7 Complete machine effect after installations of all accessories Figure 6 Figure 6 4 2 8 Switch on Figure 4 C start to use the machine as it display normally Step on the pedal after the parameters such as speed torque and water are set properly The device starts to work When the pedal is released the d...

Страница 13: ...rogram 1 Touch the corresponding icons on the screen 2 Step on the Program switchover button on the foot pedal 5 1 2 Function description of programs The function of each program is as shown as follow Icon Function Description Positioning Accurate positioning on the alveolar bone by using a positioning drill ...

Страница 14: ...he dental implant User defined mode Change straight handpiece contra angle with different speed ratios for different dental procedures Cleaning Water discharging without motor rotation is convenient for flushing 5 1 3 Factory Settings Before delivery several parameters mainly including speed torque speed ratio and water output have been set according to the actual application These parameters can ...

Страница 15: ...00 2500 800 D 5 80 35 D 16 1 20 1 27 1 20 1 D 40 Hole broadening 200 2500 600 D 5 80 35 D 16 1 20 1 27 1 20 1 D 40 Tapping 15 100 20 D 5 80 35 D 16 1 20 1 27 1 20 1 D 40 Implanting 15 100 20 D 5 80 35 D 16 1 20 1 27 1 20 1 D 0 Lock the abutment screw 15 100 20 D 5 15 10 D 16 1 20 1 27 1 20 1 D 0 User defined mode 15 40000 1200 D 5 80 45 D 1 1 1 2 1 3 1 5 16 1 20 1 27 1 20 1 D 40 Cleaning 80 Note t...

Страница 16: ...s are as follow 1 Maximum speed 2 Maximum torque 3 Water output 4 Speed ratio 5 2 1 Maximum speed adjustment Touch the Speed key to adjust motor speed The speed will change each time after touching the Speed key Long press the Speed key to accelerate the change of speed setting value ...

Страница 17: ...ent Touch the Torque key to adjust maximum torque output of motor The torque will change each time after touching the Torque key Long press the Torque key to accelerate the change of torque setting value 5 2 3 Water output adjustment ...

Страница 18: ...ater levels The water level will change to the next level after each touch Step on the blue Water volume adjustment button to adjust water volume 5 2 4 Speed ratio adjustment Adjust by pressing the Speed Ratio button to match the gear ratio of the handpiece to be used ...

Страница 19: ... 5 3 Motor rotating direction adjustment Touch the key shown above to change the rotating direction of motor Step on the Forward reverse rotation during operation to change the rotating direction of motor ...

Страница 20: ...nt Touch the LED button to for setting to determine the on or off state of LED while stepping on foot pedal The state of LED will change once after each touch Only the device with LED owns this function 5 5 Save the parameters ...

Страница 21: ... on the Program switchover button on the foot pedal to choose the program 3 Confirm that the speed torque water flow forward reverse rotation speed ratio and other parameters of corresponding program meet the requirements 4 Step on the foot pedal and then motor starts to rotate Deep step to accelerate the maximum speed value is the current program speed setting value light step to reduce the speed...

Страница 22: ... cloth and wipe with a soft cloth dampened with alcohol Handpiece and motors can be disinfected with heat sterilizers Plug in motor disinfection stopper before disinfection of motor Before the first use it is recommended to let it be autoclaved under 134 and 0 20 0 23 MPa for not less than 4 minutes Warning Never place the main unit and foot controller in a washer disinfector autoclave or ultrason...

Страница 23: ...SO 15883 1 and refer to the instructions of the cleaning machine Do not automatically clean the main unit Disinfection After any pre cleaning wipe all visible surfaces of the device including water bottle hooks pedals and cables with a disposable soft cloth dampened with disinfectant at least 30 s to ensure that all surfaces are wet and allow to act contact time 30 minutes If large surfaces have t...

Страница 24: ...s not connected Make sure that the foot pedal is connected If the problem cannot be solved please contact local distributors or manufacturer Error 02 Motor over current Please contact local distributors or manufacturer Error 03 Motor overheat Please contact local distributors or manufacturer Error 04 Motor phase default Please contact local distributors or manufacturer Error 05 Motor light abnorma...

Страница 25: ...ied oil and disinfected as per requirements If it is not used for a period please clean it apply oil to it and disinfect is at least once a week Replacement of fuse Power supply shall be cut off while intending to conduct the following operations And disconnect power supply cable and main power supply See Figure 7 Refer to B Figure 7 1 Danger Switch off the apparatus 2 Insert a flat blade screwdri...

Страница 26: ...f Strong water spraying experiment Type B applied part Can be autoclaved Caution Protective earthing Serial number Humidity limit for storage Atmospheric pressure for storage Temperature limit for storage Appliance complies with WEEE directive CE marked product Authorised Representative in the EUROPEAN COMMUNITY Note Please refer to product packaging label for production date ...

Страница 27: ...ure 41 8 Maximum water volume 110ml min Dimension 265mm 263mm 119mm Operation environment Environment temperature 5 40 Relative humidity 30 75 Atmosphere pressure 70kPa 106kPa Device case material PC ABS Handpiece material brass 10 2 Motor specifications Model SPM58L SPM58NL SPM58 SPM58LS Rotating speed range 300 40 000 rpm Torque range 5 80 Ncm ratio 20 1 Input voltage DC27V Dimension Maximum dia...

Страница 28: ...14 Guarantee 14 1Before being put into market all woodpeckers device should be thoroughly inspected to ensure proper use 14 2Woodpecker promised that for any new products purchased from authorized distributors or importers of Woodpeckers if ill function is resulted from the quality problem you are entitled to free replacement during the warranty period One year since the date of purchasing equipme...

Страница 29: ...lowing information 14 8 1 Buyer information including phone numbers etc 14 8 2 Distributor or importer information 14 8 3 A copy of the photo of the goods date of purchase problem of part part name and serial number 14 8 4 Description of the problem 14 9Any damage caused during transportation is not under warranty If the problem is caused by incorrect use the repair fee should be undertaken by the...

Страница 30: ...e Declaration electromagnetic immunity The model Implant X is intended for use in the electromagnetic environment specified below The customer or the user of the model Implant X should assure that It is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD lEC 61000 4 2 8kV contact 2 4 8 15kV air 8kV contact...

Страница 31: ...odels Implant X be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field lEC 61000 4 8 30A m 30A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level Table 3 Guidance Declaration electromagnetic imm...

Страница 32: ...requency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically ...

Страница 33: ...er m 150kHz to 80MHz d 1 2 P1 2 80MHz to 800MHz d 1 2 P1 2 800MHz to 2 7GHz d 2 3 P1 2 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 estimated using the equation applicable to the frequency of the transmitter where P is the maximum output pow...

Страница 34: ...ZMN WI 09 426 V1 3 20181218 ...

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