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Sendoline Endo Motor Instruction Manual

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  • Page 2: Table Of Contents

    Contents 1 Product introduction ................1 2 Installation .................... 5 3 Function and operation of product ............12 4 Operation instruction ................15 5 Troubleshooting................... 30 6 Cleaning, Disinfection and Sterilization ..........31 7 Storage, maintenance and transportation ..........40 8 Environmental protection ..............

  • Page 3: Product Introduction

    Endo Motor (mode ： Ai-Motor) is mainly used in Endodontic treatment. It is a cordless endo motor with root canal measurement capability. It can be used as an endo motor for preparation and enlargement of root canals, or device for measuring canal length. It can be used to enlarge the canals while monitoring the position of the file tip inside the canal.
  • Page 5 1.5 Indications for Use Endo Motor, Ai-Motor is cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used for preparation and enlargement of root canals, or measuring the canal length. And it can be used to enlarge the canals while monitoring the position of the file tip inside the canal.
  • Page 6 1.9.7 Please use original power adapter. Other power adapter will result in damage to lithium battery and control circuit. 1.9.8 The motor handpiece cannot be autoclaved. Use disinfectant of neutral pH value or ethyl alcohol to wipe its surface. 1.9.9 Before the contra angle stopping rotating, do not press the push cover of contra angle.

  • Page 7: Installation

    1.11 Primary technical specifications 1.11.1 Battery Lithium battery in motor handpiece: 3.7V /2000mAh 1.11.2 Power adapter (Model: ADS-6AM-06N 05050/UE08WCP- 050100SPA) Input: ~100V-240V 50Hz/60Hz 0.4A Max Output: 5.0V 1.11.3 Torque rang: 0.4Ncm-5.0Ncm （ 4mNm ~ 50mNm ） 1.11.4 Speed rang: 100rpm~1800rpm 1.11.5 Wireless charging (only for Ai-Motor) Frequency range: 112-205KHz Maximum RF output power of the product: 9.46dBuA/m@3m...
  • Page 8 Power adapter Measuring wire File clip Lip hook Touch probe Disposable insulation sleeves Display Screens 2.2.1 Display Screens for 6 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.
  • Page 9 2.2.1.3 CCW Mode The motor handpiece rotates counterclockwise direction only. This mode is used to inject calcium hydroxide and other medicant. When this mode is being used, a double-beep sounds continuously. 2.2.1.4 SGP Mode Safety Glide Path Mode F: Forward angle, R: Reverse angle The rotation angle is adjustable, but the forward angle must be equal to the reverse angle.
  • Page 10 2.2.3 Canal Measurement Display This appears when a file is inside the canal and the lip hook is contacting the patient mouth. Bars in meter show the location of the file tip. In the EAL Mode, If the length is less than 1.0, the display will be enlarged.
  • Page 11 Align any locating pin of the contra-angle with the positioning slot on the motor handpiece and push the contra-angle horizontally. The three locating pins on the contra-angle are inserted into those three positioning holes on the motor handpiece. A “click” sound indicates that the installation is in place.
  • Page 12 Before starting the device, plug the file into the hole of contra angle head. Hold down the push button on the contra angle and insert the file. Turn the file back and forth until it is lined up with interior latch groove and slips into place.
  • Page 13 chuck of contra angle. 2.6 Canal measurement functional connection This is not required if the canal measurement function will not be used. Connect the measuring wire to the motor handpiece. Line up the measuring wire plug with the notch on the back of the motor and push it all the way in.

  • Page 14: Function And Operation Of Product

    2.7.1 Installation Before each use of the handpiece and after the handpiece is cleaned and disinfected,put on a disposable insulating sleeve. Take the insulating sleeve out of the insulating sleeve box, then insert the insulating sleeve into t h e motor handpiece from the thin end of the handpiece and install the insulating sleeve until there is no obvious wrinkle.
  • Page 15 f. Handpiece functions setting With the motor handpiece turned off, hold down the Setting button “P” and press Main button to entry handpiece functions setting, press Setting button “P” till target setting, press Adjusting button “+”/“-” to adjust, then press Main button to confirm. 3.2 Screen display Standby interface a.
  • Page 16 Apical reference point setting interface a. Apical reference point flash bar b. Apical foramen c. Digital “02” meter reading, very near physiological apical foramen. 3.3 Terms and definition Clockwise rotation, forward ration Be applied to rotary file Counter clockwise rotation, reverse rotation Be applied to special file, inject calcium hydroxide and other solutions Safety Glide Path Mode...

  • Page 17: Operation Instruction

    5 operation modes for canal shaping and Operation Mode measurement. Such as CW, CCW, SGP, ATR and EAL. Speed File rotation speed. For CW and CCW modes, the torque value Torque (Torque Limit) that triggers reverse rotation. For (Torque Limit / ATR mode, the torque value (Trigger Torque) Trigger Torque) that triggers ATR action.
  • Page 18 sequence number during standby state. M0-M9 is a memory program for canal shaping and measurement, every memory program has its own parameters such as Operation mode, speed and torque, all these parameters can be changed.
  • Page 19 4.3 Parameter setting Before starting of motor handpiece, please check the operation mode is correct. It has 5 operation modes for canal shaping and measurement: CW, CCW, SGP, ATR and EAL(See chapter 3.3 Terms and definition to get the explanations of these modes.) Press Setting button “P”...
  • Page 20 The torque setting can be adjusted from 0.4Ncm to 5.0Ncm. Press Adjusting button “+”/“-” to increase or decrease torque. Long press to fast increase or fast decrease torque. In ATR mode, the Trigger Torque of 0.4Ncm~ 4.0Ncm are available. In SGP mode, the torque of 2.0Ncm~5.0Ncm are available.
  • Page 21 Rotation stops automatically when the file is taken out of the canal and the canal length indicator bar lights up less than 2 bars before the file is taken out. Press Adjusting button “+”/“-” to change. OFF: Motor does not stop when file is taken out the canal.
  • Page 22 4.4 Preset program selection For convenience, we preset some common file system. Press Adjusting button “+”/“-” to switch to preset program(M0-M9, preset program 1-5 ), the interface will show as left. Long press Setting button “P” to entry preset program during standby state, the interface will show as left.
  • Page 23 After 3 seconds of displaying the version number on the screen, the "Auto Power OFF" can be change, press Adjusting button “+”/“-” to adjust, then press to "Main" button to confirm. It can be set from 3 to 30 minutes in 1 minute increments.
  • Page 24 Press Setting button “P” again, the "Restore Defaults" can be change, press Adjusting button “+”/“-” to select “ON”, then press to "Main" button to restore defaults. 4.6 Protective function of automatic reverse During operation, if the load value exceeds the preset torque value, the file rotation mode will automatically change to Reverse Mode.
  • Page 25 Motor alone mode When using as motor alone mode, the torque bar will show on the screen. (more information about torque bar, please see chapter 3. 2 Screen display) Motor combined canal measurement function mode When using motor combined canal measurement function, the measuring wire must be connecting with motor handpiece by USB socket, and white socket connects...
  • Page 27 4.8 Canal measurement operation When using as alone apex locator mode. We suggest put the motor handpiece on the charging base to get better visual angle. Press Setting button “P” once during standby state, press Adjusting button “+”/“-” to select EAL Operation mode, then press Main button to confirm.
  • Page 28 Connection testing Strongly recommend check the connection testing every time before use. Clip the holder onto lip hook and check that all the bars on the meter on the screen light up, otherwise, the measuring wire or file clip should be replaced.
  • Page 29 Root canal with blood overflowing from the opening If blood overflows from the opening of the root canal and contacts the gums, this will result in electrical leakage and an accurate measurement cannot be obtained. Wait for bleeding to stop completely. Clean the inside and opening of the canal thoroughly to get rid of all blood, and then make a measurement.
  • Page 30 Re-treatment of a root filled with gutta- percha The gutta-percha must be completely removed to eliminate its insulating effect. After removing the gutta-percha, pass a small file all the way through the apical foramen and then put a little saline in the canal, but do not let it overflow the canal opening.
  • Page 31 The actual apex for the canal is not the same as that for the anatomical apex. There are frequently cases where the apical foramen is located up towards the crown. In these cases, an X-ray might indicate that the file has not reached the apex even though it has actually reached the apical foramen.

  • Page 32: Troubleshooting

    2. Next, plug the nozzle into the end part of contra angle, and then grease the contra angle for 2-3s till the oil flow out of contra angle head part. 3. Vertically place the end part of contra angle more than 30 minutes to let go the redundant oil under gravity.

  • Page 33: Cleaning, Disinfection And Sterilization

    No sound Beeper Volume set to 0. Set Beeper Volume to Vol.0: Mute. 1,2,3. The continuously Incorrect specification Choose CCW Mode, rotating file is stuck at start the motor setting. the root canal. handpiece, and take the Too high load torque of file.
  • Page 34 aldehyde free solution) approved by VAH/DGHM-listing, CE marking, FDA and Health Canada. Warning: Do not sterilize the motor handpiece, the AC adapter and the base. 6.3.1 Pre-Op processing Before each use, the handpiece, charger, and base must be cleaned and disinfected. The specific steps are as follows: Warning: The handpiece, charger, and base cannot be cleaned and disinfected with automatic equipment.
  • Page 35 6.3.2 Post-Op processing After each use, clean and disinfect the handpiece, charger, and base within 30 minutes. The specific steps are as follows: Tools: Nap-free soft cloth, tray 1. Remove the contra-angle from the handpiece, place it in a clean tray, and then remove the disposable insulating sleeve from the handpiece.
  • Page 36 completion of effective cleaning and disinfection. Please ensure that, as part of your responsibility for the sterility of products during use, only sufficiently validated equipment and product-specific procedures are used for cleaning/disinfection and sterilization, and that the validated parameters are adhered to during every cycle. Please also observe the applicable legal requirements in your country as well as the hygiene regulations of the hospital or clinic, especially with regard to the additional requirements for the inactivation of prions.
  • Page 37 Disassembling steps a) Press the push-button and pull out the shank/file. b) When removing the protective silicon cover, pull it straight out slowly. c) When inserting and removing the contra-angle, turn the handpiece power off beforehand. 6.4.3 Cleaning The cleaning should be performed no later than 24 hours after the operation.
  • Page 38 otherwise, the protein will solidify and it would be difficult to remove. c) After cleaning, the chemical residue should be less than 10mg / L. 6.4.4 Disinfection Disinfection must be performed no later than 2 hours after the cleaning phase. Automated disinfection is preferred if conditions permit. 6.4.4.1 Automated disinfection-Washer-disinfector ·The washer-disinfector is proved to be valid by CE certification in accordance with EN ISO 15883.
  • Page 39 (Dr. Weigert). d) Disinfection: (d1) Direct use after disinfection: temperature ≥ 90 ° C, time ≥ 5 min or A0 ≥ 3000; Sterilize it after disinfection and use: temperature ≥ 90 ° C, time ≥1 min or A0 ≥ 600 (d2) For the disinfection here, the temperature is 93 °...
  • Page 40 please replace it before use. And the new accessories for replacement must be cleaned, disinfected and dried. 4. If the service time (number of times) of the product reaches the specified service life (number of times), please replace it in time. 6.4.6.2 Maintenance Sterilizable Oil lubrication shall be applied to dried contra angle.
  • Page 41 Exposure Drying Mode Vacuum Temperature Cycle Time Time Fraction 30 seconds 20 minutes Half 1 2 minutes 20 minutes Half 2 2 minutes 20 minutes PreVac - 80 kPa (132-134) °C Half 3 2 minutes 20 minutes Full 4 minutes 20 minutes Verification of the fundamental suitability of the products for effective steam sterilization was provided by a verified testing laboratory.

  • Page 42: Storage, Maintenance And Transportation

    b) Product storage must be marked and recorded. 6.4.10 Transportation 1. Prevent excessive shock and vibration during transportation, and handle with care; 2. It should not be mixed with dangerous goods during transportation. 3. Avoid exposure to sun or rain or snow during transportation. 7 Storage, maintenance and transportation 7.1 Storage 7.1.1 This equipment should be stored in a room where the relative...

  • Page 43: Environmental Protection

    8 Environmental protection Please dispose according to the local laws. 9 After service From the date this equipment has been sold, based on the warranty card, we will repair this equipment free of charge if there are quality problems. Please refer to the warranty card for the warranty period. 10 European authorized representative 11 Symbol instruction Follow Instructions...

  • Page 44: Emc-Declaration Of Conformity

    All rights of modifying 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.
  • Page 45 The model Ai-Motor is intended for use in the electromagnetic environment specified below. The customer or the user of the model Ai-Motor should assure that It is used in such an environment. Electromagnetic IEC 60601 Immunity test Compliance level environment - guidance test level ±8kV contact ±8kV contact...
  • Page 46 Table 3: Guidance & Declaration - electromagnetic immunity concerning Conducted RF & Radiated RF Guidance & Declaration - Electromagnetic immunity The model Ai-Motor is intended for use in.the electromagnetic environment specified below. The customer or the user of the models Ai-Motor should assure that it is used in such an environment.
  • Page 47 ZMN-SM-410 V1.5-20220110 107070_IFU_SendolineEndoMotor_EN...

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