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Summary of Contents for Guilin Woodpecker Medical Instrument Endo 3
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Page 2: Table Of Contents
Contents Preface -------------------------------------------------------------------- 1 1 Product introduction --------------------------------------------------- 1 2 Product components -------------------------------------------------- 1 3 Basic technical parameters ------------------------------------------- 2 4 Installation and removal method ------------------------------------- 3 5 Operation --------------------------------------------------------------- 4 6 Charging instructions -------------------------------------------------- 5 7 Safety precautions ----------------------------------------------------- 5 8 Product contraindications --------------------------------------------- 6 9 Cleaning, disinfection and sterilization ------------------------------- 7 10 Daily maintenance -------------------------------------------------- 1 3... -
Page 3: Preface
1.3.2 Scope of application Endo 3 Ultrasonic Endo Activate Device applies to root canal irrigation. 2 Product components This product is composed of host, charging base, tips, Endo wrench, 5V... -
Page 4: Basic Technical Parameters
power adapter, disposable isolation sleeve, protective silicone cover. Note: The isolation sleeve is for single use only, please do not reuse. 3 Basic technical parameters 3.1 Dimensions: 173.8mm×25.8mm×35.8mm 3.2 Net weight: 78g 3.3 Machine configuration list: See details in packing list 3.4 Classified by power supply: Powered by rechargeable batteries 3.5 Rechargeable lithium battery: Battery mode: DLG 14500... -
Page 5: Installation And Removal Method
Relative humidity at 30% -75% Atmospheric pressure:70kPa ~ 106kPa 3.10 Device safety classification: 3.10.1 Applied part: Tips 3.10.2 Type of Operation mode: Non continuous operating device. Duty cycle:ON/OFF:Max 1min/Min 2min 3.10.3 Type of protection against electric shock: Class II equipment with internal power supply 3.10.4 The contact duration of applied part:No more than 1 minute. -
Page 6: Operation
Screw the tip with an Endo wrench in clockwise direction and press the button to use the machine. (Rotate the tip counterclockwise to remove it.) The installation and removal method of the tip is shown in the figure below: Note: The installation or removal of the tip shall be carried out under the shutdown mode of the host. -
Page 7: Charging Instructions
switching button and the ring switch button at the same time, the host will enter the time adjustment state (at this time, the middle character will jump constantly). And then, lightly press the mode switching button to select the duration time of the irrigation mode. There are four kinds of working time of this machine: 10, 15, 20 and --, which means 10s, 15s, 20s and 10min respectively.After selection, press the mode switching button and ring switch button at the same time again, the host will exit the time adjustment... -
Page 8: Product Contraindications
goggles, masks, etc. to prevent cross-infection while operating. 7.4 The use of the product must meet the requirements of the relevant operation normalization and relevant regulations of medical department, and the use is limited to the trained doctors or technicians. 7.5 The tip,protective silicone cover and Endo wrench must be sterilized before each treatment. -
Page 9: Cleaning, Disinfection And Sterilization
8.3 The patients with heart pacemaker are forbidden to use this equipment. 8.4 Heart disease patients, pregnant women and children should be cautious to use the equipment. 9 Cleaning, disinfection and sterilization This product is provided non-sterile, please clean, disinfect and sterilize tip, Endo wrench and protective silicon cover before use.The cleaning, disinfection and sterilization of tip, Endo wrench and protective silicon cover are as follow. - Page 10 a) The water used here must be pure water, distilled water or deionized water. 9.2 Preparation before cleaning Steps: Tools: Endo wrench, tray, soft brush, clean and dry soft cloth 1. Remove the tip from host with Endo wrench provided by Guilin Woodpecker Medical Instrument Co., Ltd, and then put the tip and wrench into a clean tray.
- Page 11 It is recommended to use a washer-disinfector in accordance with EN ISO 15883. For the specific procedure, please refer to the automated disinfection section in the next section "Disinfection". Notes a) The cleaning agent used here must be compatible with the product and only freshly prepared solutions can be used.
- Page 12 product to be treated. The flushing period should be sufficient (5-10 minutes). Pre-wash for 3 minutes, wash for another 5 minutes, and rinse it for twice with each rinse lasting for 1 minute. (c2) In the washing stage, the water temperature should not exceed 45 °C, otherwise the protein will solidify and it is difficult to remove.
- Page 13 9.6.3 Check the product. If the accessories are found to be damaged, please replace it before use. And the new accessories for replacement must be cleaned, disinfected and dried. 9.6.4 If the service time (number of times) of the product reaches the specified service life (number of times), please replace it in time.
- Page 14 not been recommended. If you use the sterilization procedures that have not been recommended, please adhere to related effective standards and verify the suitability and effectiveness. * Fractional pre-vacuum procedure = steam sterilization with repetitive pre- vacuum. The procedure used here is to perform steam sterilization through three pre-vacuums.
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Page 15: Daily Maintenance
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 as Oxytech from Germany, but you must respect the concentration, temperature and time specified by the disinfectant manufacturer. -
Page 16: Troubleshooting
11 Troubleshooting Fault Possible cause Solution The battery capacity of Connect the power Endo 3 Ultrasonic Endo supply to charge / Activate Device is low. replace the battery The battery is damaged. Replace the battery Continuously using for a l... -
Page 17: After-Sales Service
12.5 Do not put it together with dangerous goods during transportation. 12.6 Avoid being exposed to sun, rain, and snow during transportation. 13 After-sales service Since the date of sale, for the ill function of this machine caused by quality problem, our company is responsible for the maintenance during warranty. -
Page 18: Electromagnetic Compatibility
17.2 Guidance and manufacturer’s declaration – electromagnetic emissions Guidance and manufacturer’s declaration – electromagnetic emissions Endo 3 Ultrasonic Endo Activate Device is intended for being used in the electromagnetic environment specified below. The customers or users of Endo 3 Ultrasonic Endo Activate Device should assure that it is used in such an environment. - Page 19 Guidance and manufacturer’s declaration – electromagnetic immunity Endo 3 Ultrasonic Endo Activate Device is intended for being used in the electromagnetic environment specified below. The customers or users of Endo 3 Ultrasonic Endo Activate Device should assure that it is used in such environment. IEC 60601...
- Page 20 Guidance and manufacturer’s declaration – electromagnetic immunity Endo 3 Ultrasonic Endo Activate Device is intended for being used in the electromagnetic environment specified below. The customers or users of Endo 3 Ultrasonic Endo Activate Device should assure that it is used in such environment. IEC 60601...
- Page 21 Endo 3 Ultrasonic E n d o A c t i v a t e D e v i c e , i n c l u d i n g c a b l e s .
- Page 22 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be taken into consideration. If the measured field strength in the location where Endo 3 Ultrasonic Endo Activate Device is used exceeds the applicable RF compliance level above, the Endo 3 Ultrasonic Endo Activate Device should be observed to verify normal operation.
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Page 23: Statement
Endo 3 Ultrasonic Endo Activate Device has been tested in accordance with YY 0505-2012/IEC 60601-1-2-2014. This does not guarantee in any way that this device will not be affected by electromagnetic interference. - Page 24 ZMN-SM-280 V1.0-20220622...
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