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49

 

 

Technical Description Concerning Electromagnetic Emission 
Table 1: Declaration - electromagnetic emissions

 

Guidance and manufacturer’s declaration - electromagnetic emissions

 

The model Ai-Motor 

MotoPex is intended for use in the electromagnetic 

environment specified below. The customer or the user of the model Ai-Motor

MotoPex should assure that it is used in such an environment.

 

Emissions test

 

Compliance

 

Electromagnetic environment -

 

guidance

 

 

 

RF emissions 
CISPR 11

 

 
 

Group 1

 

The model Ai-Motor

 

MotoPex uses RF energy

 

only for its internal function. 
Therefore, its RF emissions 
are very low and are not likely 
to cause any interference in 
nearby electronic equipment.

 

RF emissions

 

CISPR11

 

Class B

 

The model Ai-Motor /

 

MotoPex is suitable for use

 

in all establishments, including 
domestic establishments and 
those directly connected to

 

the public low-voltage power 
supply network that supplies 
buildings used for domestic 
purposes.

 

Harmonic emissions

 

lEC 61000-3-2

 

Class A

 

Voltage fluctuations / 
flicker emissions 
lEC 61000-3-3

 

 

Complies

 

 

Technical Description Concerning Electromagnetic Immunity 
Table 2: Guidance & Declaration - electromagnetic immunity

 

Guidance & Declaration — electromagnetic immunity

 

The model Ai-Motor 

、 

MotoPex is intended for use in the electromagnetic 

environment specified below. The customer or the user of the model Ai-Motor

MotoPex 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

 

±2, ±4, ±8, ±15kV

 

air

 

Floors should be wood, 
concrete or ceramic tile. 
If floors are covered with 
synthetic material, the 
relative humidity should

 

be at least 30 %.

 

 

Summary of Contents for Ai-Motor MotoPex

Page 1: ...Please read this User Manual carefully before use for operating instructions care and maintenance ...

Page 2: ...ation instruction 17 5 Troubleshooting 31 6 Cleaning Disinfection and Sterilization 32 7 Storage maintenance and transportation 41 8 Environmental protection 42 9 After service 42 10 European authorized representative 42 11 Symbol instruction 43 12 Statement 43 13 EMC Declaration of conformity 43 ...

Page 3: ...oPex is used in Endodontic treatment It is a cordless endo motor with an integrated apex locator It can be used as an endo motor to prepare and enlarge root canals or as a device for measuring canal length It can be used to enlarge the canals while monitoring the position of the file tip inside the canal Features a Efficient brushless motor low noise long service life b Cordless portable endo moto...

Page 4: ...2 ...

Page 5: ...3 ...

Page 6: ...ironment 1 7 4 This device requires special precautions regarding electromagnetic compatibility EMC and must be in strict accordance with the EMC information for installation and use Do not use this equipment especially in the vicinity of fluorescent lamps radio transmitting devices remote control devices handheld and mobile high frequency communication devices 1 7 5 Reciprocating mode usage for a...

Page 7: ...d for some time 1 7 17 Wireless charging will generate heat and the surface temperature of the charging base and motor handpiece will rise It is recommended that the time of contact between the motor handpiece and charging base during wireless charging should not exceed 10 seconds only for Ai Motor 1 8 Device safety classification 1 8 1 Type of operation mode Continuous operating device 1 8 2 Type...

Page 8: ... 4 Speed rang 100rpm 1200rpm 1 9 5 Wireless charging only forAi Motor Frequency range 112 205KHz Maximum RF output power of the product 9 46dBuA m 3m 1 10 Environment parameters 1 10 1 Environment temperature 5 40 1 10 2 Relative humidity 30 75 1 10 3 Atmospheric pressure 70kPa 106kPa 2 Installation 2 1 Basic accessories of product Motor handpiece Contra angle Ai Motor Charging base MotoPex Chargi...

Page 9: ...isplay Screens 2 2 1 Display Screens for 5 Operation Modes and Standby 2 2 1 1 EAL Mode This mode is for canal measurement The motor handpiece does not run in this mode 2 2 1 2 CW Mode The motor handpiece rotates forward 360º clockwise direction It is used for rotary files such as WOODPECKER W3 Pro ...

Page 10: ...ence between the forward angle and reverse angle should be greater than or equal to 120 degrees otherwise root canals cannot be prepared effectively Forward Angle Reverse Angle such as F 30 R 150 the effective cutting angle is Reverse Angle it is suitable for use of the reciprocating files such as WOODPECKER W3 ONE Forward Angle Reverse Angle such as F 180 R 30 the effective cutting angle is Forwa...

Page 11: ...ad on the file is greater than the set torque limit the file will start to rotate alternately at the set angle 2 2 2 Torque Display This appears when the device is operating Display shows the torque load on the file ...

Page 12: ...gital number 00 indicates that the file has reached the apical foramen Subtract 0 5 1mm from the measured file length as the working length These numbers are used to estimate the canal s working length 2 3 Instructions for contra angle 2 3 1 The contra angle adapts precision gear transmission and the transmission ratio is 6 1 2 3 2 Before the first use and after the treatment please clean and disi...

Page 13: ... corresponding three positioning holes on the motor handpiece a click sound indicates that the installation is achieved The contra angle can be rotated 360 freely The contra angle is free to rotate adapting to the root canal in different positions and it is convenient to watch the display on the device when operating by adjusting the position of the contra angle head 2 4 2 Removal Pull out the con...

Page 14: ...ented with an interior latch groove and slips into place Release the push button to make sure the file is engaged properly in the contra angle head Warnings After plugging the file into contra angle release the push button and assure that the file cannot be taken out by gently pulling it Be careful when inserting files to avoid injury to fingers Inserting and removing files without holding the pus...

Page 15: ...e working length is measured or to simultaneously monitor the working length during canal preparation Connect the measurement cable to the motor handpiece Connect the measurement cable and turn on the device Connect the metal part of the connection hook to the lip clip Make sure that the accessories are cleaned properly before the test Orient measurement cable plug with the notch on the back of th...

Page 16: ...dpiece and after the handpiece is cleaned and disinfected a disposable isolation sleeve should be used to cover the handpiece Take the isolation sleeve out of the isolation sleeve box and cover the motor handpiece from the thin end without any obvious wrinkle After covering the handpiece with the disposable isolation sleeve wrap the barrier film around the handpiece surface clean and disinfect the...

Page 17: ...pter 6 3 for cleaning and disinfection procedures 2 7 2 Removing After each use remove the barrier film and slowly pull the isolation sleeve from the thin end of the handpiece Warming Isolation sleeves are notreusable ...

Page 18: ...etting Press Setting button P till target parameters press Adjusting button to change then press Main button or wait 5 seconds to confirm e Preset program selection Long press Setting button P to enter the preset program during standby state press Adjusting button to select file system press Setting button P to enter the select file number press Adjusting button to select file number then press th...

Page 19: ...Operation mode Working interface a Set speed b Set torque c Real time torque d Torque display scale Working length measurement mode interface a Apical reference point flash bar b EAL Electronic apex locator Working Length measurement state interface a Canal length indicator bar b Indication number Digital numbers 00 16 do not represent the actual length from the apical foramen It simply indicates ...

Page 20: ...otor will function in rotation mode Forward Angle Angle of clockwise rotation of the file Reverse Angle Angle of counterclockwise rotation of the file EAL Electronic apex locator In this mode the device functions as a stand alone apex locator AP Apical foramen Apical Action The file action when file tip reaches the flash bar point Flash Bar Position Shows the point inside the canal where specified...

Page 21: ...or handpiece when the main button is pressed the motor handpiece will enter Standby interface The interface displays are shown below b Under Standby interface press the Main button and then the motor handpiece will enter Working interface The interface displays are as follow c When you press the main button again the motor handpiece will Working interface displays are as follow Working interface d...

Page 22: ...t and all the parameters must be set according to the file system intended to use to prevent the file separation in the canal It has 5 operation modes for canal shaping and measurement CW CCW REC ATR and EAL See chapter 3 3 Terms and definition to get the explanations of these modes Press Setting button P once during standby state press Adjusting button toselect the correct Operation mode Counterc...

Page 23: ...that happen automatically when the file tip reaches the point inside the canal determined by the Flash Bar setting This action is due to the integration of the working length determination function when the file reaches the reference point the motor will respond according to the setting it can either be Reverse Stop or OFF Press the Adjusting button to change OFF It disables the apical Action func...

Page 24: ...the Adjusting button to change OFF Motor does not stop when the file is taken out of the canal The Main button should be used to start and stop the motor handpiece This is the reference point where various apical actions are triggered Press the Adjusting button to select a reference point by change the flash bar The meter s 0 5 reading indicates that the file tip is located very near the physiolog...

Page 25: ...ely Forward Angle Reverse Angle such as F 30º R 150º the effective cutting angle is Reverse Angle is suitable for the reciprocating files such as WOODPECKER W3 ONE Forward Angle Reverse Angle such as F 180º R 30º the effective cutting angle is Forward Angle is suitable for the reciprocating files such as SENDONELINE S1 4 3 Preset program selection For convenience some file systems are preset Press...

Page 26: ... prevent file separation 4 4 Handpiece functions setting 4 5 With the motor handpiece turned off hold down the Setting button P and press the main button to enter handpiece functions setting press Setting button P till target setting press the Adjusting button to adjust then press the main button to confirm With the motor handpiece turned off when the Setting button P held down and pressing the ma...

Page 27: ...ton to select ON then press the Main button to calibrate Before calibrating make sure the original contra angle is installed before inserting any file The torque set will not be correct if calibration is done without the original contra angle or any load is applied on the contra angle chuck and may result in file separation After replacement of the contra angle the contra angle should be calibrate...

Page 28: ...c reverse During operation if the load value exceeds the preset torque value the file rotation mode will automatically change to Reverse Mode The file would return to normal rotation mode once the load is below the preset torque value again ...

Page 29: ...This function is not applicable for CCW mode and ATRmode 4 If the motor handpiece battery indicator indicates a low battery capacity it would be insufficient to support the motor handpiece to reach the preset torque value which leads to improper auto reverse function Please charge it in time 4 7 Motor operation Please set operation mode torque and speed as per the recommended specifications of fil...

Page 30: ...dicator bar please see chapter 3 2 Screen display Setting parameters of automatic functions as needed such as Apical Action Auto Start etc more information about automatic functions please see chapter 4 3 Parameter setting Connection testing It is strongly recommended to check the connection testing every time before use Touch the lip hook with the file inserted to the contra angle and check that ...

Page 31: ...s of Operation modes The measurement cable must be connected with the motor handpiece at the USB socket the white socket connects with the patient s lip by lip hook and the black socket connects with the file clip The canal length indicator bar will be shown on the screen more information about canal length indicator bar please see chapter 3 2 Screen display The file clip must hold the file correc...

Page 32: ... the bars on the meter on the display light up If this is not noticed the measuring wire or file clip should be replaced Root canal with a large apical foramen A root canal that has an exceptionally large apical foramen due to a lesion or incomplete development cannot be accurately measured The results may show a shorter measurement than the actual length ...

Page 33: ...will be inaccurate Please make sure no solution is in contact with oral tissues before measuring the working length Fractured crown If the crown is fractured and gingival tissue overgrows into the access cavity contact between the gingival tissue and the file will result in an inaccurate measurement Pre endo buildup is recommended to avoid the contact tissue with the endodontic file Fractured root...

Page 34: ...n of the file with Teflon so that the file is not in contact with the metal prosthesis while measuring the working length Extremely dry canal If the canal is extremely dry there will be no display of the file movement until it is very near to the apex Moisten the canal with saline to avoid this problem Difference in working length measurement between the apex locator Radiograph Sometimes the readi...

Page 35: ...e same direction for charging When the blue indicator on the charging base flashes it is charging When the motor handpiece is fully charged the blue indicator on the charging base would be always on Only forAi Motor After charging please unplug the power adapter 4 10 Replacing Battery Replace the battery if it seems the battery recharging time becomes shorter Please use the original lithium batter...

Page 36: ...le and grease the contra angle for 2 3s till the oil flows out of contra angle head part 3 Vertically place the end part of the contra angle for more than 30 minutes to let go of the redundant oil under gravity Warnings Motor handpiece should not be filled with oil Cautions a To avoid the contra angle from flying out due to the pressure use hand to safely hold the contra angle while greasing b Do ...

Page 37: ...r after charging Battery capacity reduced Please contact local distributor or manufacturer No sound Beeper Volume set to 0 Vol 0 Mute Set Beeper Volume to 1 2 3 The file is stuck in the root canal when used in Continuous rotation mode Incorrect setting for the file used High torque load on the file Change to CCW Mode start the motor handpiece and remove the file from the contra angle 6 Cleaning Di...

Page 38: ...odontic files refer to the manufacturer s instructions for use 6 2 9 The contra angle needs to be lubricated after cleaning and disinfection but before sterilization 6 3 Cleaning and disinfection steps for the motor handpiece the AC adapter and the base Before and after each use all the objects that were in contact with infectious agents should be cleaned using towels impregnated with a disinfecti...

Page 39: ...m Germany can be used but the concentration temperature and time specified by the disinfectant manufacture must be followed d After cleaning and disinfecting the handpiece disposable isolation sleeve should be installed before use and repeat steps 1 2 and 3 to clean the disposable isolation sleeve For detailed installation steps see section 2 7 6 3 2 Post Op processing After each use clean and dis...

Page 40: ...s have been designed for a large number of sterilization cycles The materials used in manufacturing process were selected accordingly However with every cycle thermal and chemical stresses will result in ageing of the products The maximum number of sterilizations for products is 250 times 6 4 1 Initial processing 6 4 1 1 Processing principles Effective sterilization is possible only after thorough...

Page 41: ...olation sleeve Contra angle and connecting wire from the handpiece in sequence and place them in a clean tray 3 Use a clean soft brush to carefully brush the lip hook file clip protective silicon cover touch probe head and back cover of the contra angle until debris or stains on the surface are not visible 4 Use a soft cloth to dry the products and place them in a clean tray The cleaning agent can...

Page 42: ...40 the contra angle ...

Page 43: ...e product b In the washing stage the water temperature should not exceed 45 C otherwise the protein will solidify and it would be difficult to remove c After cleaning the chemical residue should be less than 10mg L 6 4 3 Disinfection Disinfection must be performed no later than 2 hours after the cleaning phase Automated disinfection is preferred if possible 6 4 3 1Automated disinfection Washer dis...

Page 44: ...emperature should not exceed 45 C to prevent solidification of the protein which is difficult to remove c3 freshly prepared solutions such as pure water distilled water deionized water or multi enzyme solution etc can be used c4 During the use of cleaner the concentration and time provided by the manufacturer must be followed The used cleaner is neodisher MediZym Dr Weigert d Disinfection d1 Direc...

Page 45: ...43 6 4 4 Drying If the cleaning and disinfection process does not have an automatic ...

Page 46: ...arly 6 4 4 Inspection and maintenance 6 4 4 1 Inspection In this chapter we only check the appearance of the product 1 Check the product If any stain or debris is still visible on the product after cleaning disinfection the entire cleaning disinfection process must be repeated 2 Check the product If it is obviously damaged smashed detached corroded or bent it must be scrapped and should not be use...

Page 47: ...vacuum procedure for sterilization and other sterilization procedures are prohibited The steam sterilizer complies with EN13060 or is certified according to EN 285 to comply with EN ISO 17665 standards The highest sterilization temperature is 138 C The sterilization time is at least 4 minutes at a temperature of 132 C 134 C and a pressure of 2 0 bar 2 3 bars Allow a maximum sterilization time of 2...

Page 48: ...ospheric pressure of 70KPa to 106KPa and a temperature of 20 C to 55 C 2 After sterilization the product should be packaged in a medical sterilization bag or a clean sealing container and stored in a special storage cabinet The storage time should not exceed 7 days If it is exceeded it should be reprocessed before use Notes a The storage environment should be clean and must be disinfected regularl...

Page 49: ... as the running properties can change with usage cleaning and sterilization 7 2 6 Replace the battery if it seems to be running out of charge sooner than it should 7 1 Transportation 7 3 1 Excessive impact and shaking should be prevented in transportation Place the device carefully and lightly and don t invert it 7 3 2 Don t place it together with dangerous goods during transportation 7 3 3 Avoid ...

Page 50: ...g the product are reserved to the manufacturer without further notice The pictures are only for reference The final interpretation rights belong to GUILIN WOODPECKER MEDICAL INSTRUMENT CO LTD The industrial design inner structure etc have claimed for several patents by WOODPECKER any copy or fake product must undertake legal responsibilities 13 EMC Declaration of conformity The device has been tes...

Page 51: ...ments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions lEC 61000 3 2 Class A Voltage fluctuations flicker emissions lEC 61000 3 3 Complies Technical Description Concerning Electromagnetic Immunity Table 2 Guidance Declaration electromagnetic immunity Guidance Declarati...

Page 52: ... should be that of a typical commercial or hospital environment If the user of the models Ai Motor MotoPex requires continued operation during power mains interruptions it is recommended that the models Ai Motor MotoPex 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 c...

Page 53: ...Hz to 800 MHz d 2 3 P1 2 800 MHz to 2 7 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 meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur I...

Page 54: ... reorienting or relocating the model Ai Motor MotoPex b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3V m Recommended separation distances between portable and mobile RF communications equipment and the model Ai Motor MotoPex The model Ai Motor MotoPex is intended for use in electromagnetic environment in which radiated RF disturbance is controlled The customer or...

Page 55: ...of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE I At 80 MHz and 800 MHz the separation distance for the higher frequency 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 ...

Page 56: ...ZMN SM 034 V1 9 20210430 ...

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