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Summary of Contents for Guilin Woodpecker Medical Instrument Endo Pace

  • Page 2: Table Of Contents

    Contents Preface ----------------------------------------------------------- 1 1 Product introduction ---------------------------------------- 1 2 Installation ----------------------------------------------------- 3 3 Function and operation of product -------------------- 5 4 Operation instruction -------------------------------------- 7 5. Motor operation --------------------------------------------12 6 Cleaning, Disinfection and Sterilization ---------------14 7 Storage and transportation -----------------------------20 8 Environmental protection --------------------------------20 9 After service -------------------------------------------------20 10 European authorized representative -----------------20...
  • Page 3: Preface

    1 Product introduction 1.1 Product description Endo Pace is mainly used in Endodontic treatment. It is a cordless endo motor which can be connected to the matched Apex locator to add an apex locator function. It can be used as a endo motor for preparation and enlargement of root canals.
  • Page 4 1.8 Warnings 1.8.3 Do not directly or indirectly place this device near heat source. Operate and store this device in reliable environment. 1.8.4 This device requires special precautions regarding electromagnetic compatibility (EMC) and must be in strict accordance with the EMC information for installation and use.
  • Page 5: Installation

    overheated frequently, please contact local distributor. 1.8.6 Please use the original contra angle. Otherwise it will not be used or cause adverse consequences. 1.8.7 Please do not make any changes to the device. Any changes may violate safety regulations, causing harm to the patient. There will be no 1.8.8 Please use original power adapter.
  • Page 6 USB Wire Disposable insulation sleeves Protective silicon cover 2.2 Instructions for contra angle 2.2.1 The contra angle adopts precision gear transmission, and the transmission ratio is 6:1. contra angle with disinfectant of neutral PH value. After disinfection, lubricate high pressure (134°C, 2.0bar~2.3bar (0.20MPa~0.23MPa)). 2.2.3 The contra angle can only be used cooperatively with this device.
  • Page 7: Function And Operation Of Product

    Warnings: handpiece. b) After installation, please check and confirm that the contra angle has been well installed. Warnings: Be careful when inserting files to avoid injury to fingers.Inserting and contra angle. – 2.350 mm) Warnings: Before plugging and pulling out the file, the motor handpiece must be stopped.
  • Page 8 Clockwise rotation, forward ration Counter clockwise rotation, reverse rotation hydroxide and other solutions Reciprocating motion some special angle. Adaptive torque reverse Up to setting torque, the motor will move with reciprocating ATR mode ; when torque reduce to normal value, the motor will clockwise rotate. Activating in REC and ATR operation mode.
  • Page 9: Operation Instruction

    Forward Angle<Reverse Angle, such as F: 30/R: 150, effective cutting Forward Angle>Reverse Angle, such as F: 180/R: 30, effective cutting SENDONELINE S1. 3.3.1.4 ATR Mode ATR: Adaptive Torque Reverse function. 3.3.2 Torque Display This appears when the motor is running. Meter shows the torque loadon the 4 Operation instruction 4.1 Working environment parameters 4.1.1 Environment temperature: +5°C ~ +40°C...
  • Page 10 c) Hold down the Setting button “P”, then press Main button to turn off motor handpiece. In the standby interface without any key operation, 3 ~ 30 4.3 Selecting customized program sequence number The motor handpiece has 10 memory programs(M0-M9) and 5 preset programs, press Adjusting button “+”/“-”...
  • Page 11 point inside the canal determined by the Flash Bar setting. reaches the reference point, the motor will response according to setting, it can be Reverse , Stop and OFF. Press Adjusting button “+”/“-” to change. reach the reference point. Stop: automatically rotation stop when reach the reference point, upward a little bit and will rotate again.
  • Page 12 button “P” and press Main button to entry handpiece functions setting, the software version number will appear on the display screen. After 3 seconds of displaying the Software Version on the screen, the time of "Auto Power OFF" can be change, press Adjusting The default value is 5 min.
  • Page 13 2.In REC mode, when the load value is higher than preset torque value, if change to reverse rotation, and if Forward angle is less than Reverse angle, 3.This function is forbidden under CCW mode, ATR mode. 4.When the motor handpiece battery indicator indicates a low battery capacity, the low battery capacity is insufficient to support the motor handpiece to reach the limit torque value, that is, the auto-reverse function will not work properly.
  • Page 14: Motor Operation

    Warnings Cautions safely hold the contra angle while greasing. b: Do not use a swirling nozzle. Swing nozzle can only be used for injection of gas, not for oiling. 5. Motor operation 5.1 Please set operation mode, torque and speed as per the Motor alone mode When using as motor alone mode, the torque bar will show on the...
  • Page 15 It foramen. c. Apical foramen. 1) Make sure that Endo Pace is well connected with the Apex locator. 2) Hook the lip hook in the corner of the patient’s mouth. 3) Power on the motor handpiece to operate.
  • Page 16: Cleaning, Disinfection And Sterilization

    6 Cleaning, Disinfection and Sterilization 6.1 Foreword For hygiene and sanitary safety purposes, the contra-angle, the protective silicon cover must be cleaned, disinfected and sterilized before each usage to prevent any contamination. This concerns the first use, as well as all subsequent uses.
  • Page 17 Note: a) The cleaning and disinfection must be performed within 10min before use. b) The disinfectant used must be used immediately, no foaming is allowed. c) In addition to 75% alcohol, you can use non-residue disinfectants such Oxytech from Germany, but you must respect the concentration, d) After cleaning and disinfecting the handpiece, you must install a disposable isolation sleeve before use.
  • Page 18 regard to the additional requirements for the inactivation of prions. 6.4.1.2 Post-operative treatment The post-operative treatment must be carried out immediately, no later than 30 minutes after the completion of the operation. The steps are as follows: 1. Remove the products from the base, and rinse away the dirt on the surface of handpiece with pure water (or distilled water/deionized water);...
  • Page 19 Notes: a) The cleaning agent does not have to be pure water.It can be distilled water, deionized water or multi-enzyme. But please ensure that the selected cleaning agent is compatible with the product. b) In washing stage, the water temperature should not exceed 45 °C, c) After cleaning, the chemical residue should be less than 10mg / L.
  • Page 20 h) Regularly repair and inspect the disinfector. 6.4.5 Drying If your cleaning and disinfection process does not have an automatic drying function, dry it after cleaning and disinfection. Methods: 1. Spread a clean white paper (white cloth) on the flat table, point the product against the white paper (white cloth), and then dry the product with filtered dry compressed air (maximum pressure 3 bar).
  • Page 21 Use only the following steam sterilization procedures (fractional pre- vacuum procedure*) for sterilization, and other sterilization procedures are prohibited: 285 to comply with EN ISO 17665 or is cleared by FDA; The validated sterilization cycle is one (1) fraction cycle, three (3) consecutive half cycle and one (1) full cycle.
  • Page 22: Storage And Transportation

    source, and should be installed or kept in a cool, dry and ventilated place 7.3 This equipment should be stored in a room where the relative humidity is 10% ~ 93%, atmospheric pressure is 70kPa to106kPa, and the temperature is -20°C ~ +55°C. 7.4 Excessive impact and shake should be prevented in transportation.
  • Page 23: Emc-Declaration Of Conformity

    Technical Description Concerning Electromagnetic Emission Table 1: Declaration - electromagnetic emissions Guidance and manufacturer’s declaration - electromagnetic emissions below. The customer or the user of the model Endo Pace should assure that it is used in such an environment. Emissions test...
  • Page 24 Table 3: Guidance & Declaration - electromagnetic immunity concerning Conducted RF & Radiated RF Guidance & Declaration - Electromagnetic immunity below. The customer or the user of the models Endo Pace should assure that it is used in such an environment. IEC 60601...
  • Page 25 The model Endo Pace is intended for use in electromagnetic environment in which radiated RF disturbances is controlled. The customer or the user of the model Endo Pace can help prevent electromagnetic interference by maintaining a minimum distance between portable...

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