Guilin Woodpecker Medical Instrument Endo 1 Instruction Manual Download Page 11

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9.4 Disinfection

Disinfection must be performed no later than 2 hours after the cleaning 

phase. Automated disinfection is preferred if conditions permit. 

9.4.1 Automated disinfection-Washer-disinfector
·The washer-disinfector is proved to be valid by CE certification in 

accordance with EN ISO 15883.

·Use high temperature disinfection function. The temperature does not 

exceed 134 ° C, and the disinfection under the temperature cannot exceed 
20 minutes.

·The disinfection cycle is in accordance with the disinfection cycle in EN 

ISO 15883.

Cleaning and disinfecting steps by using Washer-disinfector
1. Carefully place the product into the disinfection basket. Fixation of 

product is needed only when the product is removable in the device. The 
products are not allowed to contact each other.

2. Use a suitable rinsing adaptor, and connect the internal water lines to 

the rinsing connection of the washer-disinfector. 

3. Start the program.
4. After the program is finished, remove the product from the washer-

disinfector, inspect (refer to section "Inspection and Maintenance") and 
packaging (refer to chapter "Packaging"). Dry the product repeatedly if 
necessary (refer to section "Drying").

Notes:

a) Before use, you must carefully read the operating instructions provided 

by the equipment manufacturer to familiarize yourself with the disinfection 
process and precautions.

b) With this equipment, cleaning, disinfection and drying will be carried out 

together.

c) Cleaning: (c1) The cleaning procedure should be suitable for the 

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. (c3) The solution used can be pure water, distilled water, 
deionized water or multi-enzyme solution, etc., and only freshly prepared 
solutions can be used. (c4)During the use of cleaner, the concentration and 
time provided by manufacturer shall be obeyed. The used cleaner is neodisher 
MediZym (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 

Summary of Contents for Endo 1

Page 1: ......

Page 2: ...nstructions 5 7 Safety precautions 5 8 Product contraindications 6 9 Cleaning disinfection and sterilization 6 10 Daily maintenance 13 11 Troubleshooting 14 12 Storage and transportation 14 13 After sales service 15 14 European authorized representative 15 15 Environment protection 15 16 Symbol instruction 15 17 Electromagnetic compatibility 16 18 Statement 21 ...

Page 3: ...oclaved under high temperature of 134 C and high pressure of 0 22Mpa e Root canal vibration amplitude is small which will not hurt the root canal Meanwhile it is closer to the bottom of the root canal Root canal vibration frequency is high making Irrigation more efficient 1 2 Product model Endo 1 1 3 Product principle and scope of application 1 3 1 Product principle Endo 1 Ultrasonic Endo Activate...

Page 4: ...onfiguration list See details in packing list 3 4 Classified by power supply Powered by rechargeable batteries 3 5 Rechargeable lithium battery Battery model DLG14500 Nominal voltage 3 6V Capacity 750mAh 3 6 Power adapter Input 100V 240V 50Hz 60Hz 0 5 0 2A Output DC 5V 1A Build in fuse T1A 250V ...

Page 5: ...tection against electric shock BF type applied part Degree of protection against harmful ingress of water Ordinary equipment IPX0 Degree 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 4 Installation and removal method 4 1 Open the pac...

Page 6: ...4 4 2 Screw the tip in clockwise direction and press the button to use the machine The methods of removing tips are as follow ...

Page 7: ...h pressure of 0 22MPa 5 3 Low voltage indication If the light of mode switching button turns dark or the power is not enough it means that the battery capacity is low and it needs to charge immediately 6 Charging instructions 6 1 Use the corresponding charging base Connect the power adapter with charging base and plug the host into the charging base While charging the mode switching button light w...

Page 8: ...ome other manufacturers maybe coarse rusty collapse or use other standard thread It will be easy to be broken or cause slide teeth while matching the external thread of handpiece resulting in damage beyond repair of the Ultrasonic Endo activating file Please use DTE brand work tips 8 Product contraindications 8 1 The hemophilia patient is forbidden to use this equipment 8 2 The patients with heart...

Page 9: ...reatment 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 Wet the soft cloth completely with distilled water or deionized water and then wipe all the surfaces of the handpiece tip and host until the surface of the component is not stained 2 Dry the product with a clean soft cloth and place it in a...

Page 10: ...oduct and the irrigating period is sufficient Do not clean the handpiece with ultrasound 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 does not have to be pure water It can be distilled water deionized water or multi enzyme But pl...

Page 11: ...ction and Maintenance and packaging refer to chapter Packaging Dry the product repeatedly if necessary refer to section Drying Notes a Before use you must carefully read the operating instructions provided by the equipment manufacturer to familiarize yourself with the disinfection process and precautions b With this equipment cleaning disinfection and drying will be carried out together c Cleaning...

Page 12: ...rature is 80 C 120 C and the time should be 15 40 minutes Notes a The drying of product must be performed in a clean place b The drying temperature should not exceed 138 C c The equipment used should be inspected and maintained regularly 9 6 Inspection and maintenance In this chapter we only check the appearance of the product After inspection if there is no problem the handpiece should be immedia...

Page 13: ...cleaned and disinfected are allowed to be sterilized b Before using the sterilizer for sterilization read the Instruction Manual provided by the equipment manufacturer and follow the instructions c Do not use hot air sterilization and radiation sterilization as this may result in damage to the product d Please use the recommended sterilization procedures for sterilization It is not recommended to ...

Page 14: ... soft cloth completely with distilled water or deionized water and then wipe all the surfaces of the host until the surface of the component is not stained 2 Wipe the surface of the host with a dry soft nap free cloth 3 Repeat the above steps at least 3 times Note a Use distilled water or deionized water for cleaning at room temperature 1 2 Manual disinfection steps 1 Soak the dry soft cloth with ...

Page 15: ... as Oxytech from Germany but you must respect the concentration temperature and time specified by the disinfectant manufacturer 10 Daily maintenance 10 1 This product does not contain self repair spare parts The machine maintenance should be done by designated professionals or in the authorized maintenance shop 10 2 For this product only handpiece torch wrench and tips can be sterilized under high...

Page 16: ... working Malfunction of host Send to maintenance department Do not charge after connecting to power adapter The power supply was not well connected Pull out and connect again The power supply is broken or the specification does not match Replace the battery There are impurities on the thimble of charging base Use ethyl alcohol to clean the thimble on charging base The battery can be used for a sho...

Page 17: ... during warranty The warranty period and scope of warranty refers to the product warranty card 14 European authorized representative 15 Environment protection The device does not contain any harmful ingredients It can be handled or destroyed in accordance with the relevant local regulations 16 Symbol instruction Product registered trademark Product registered trademark Connection of handpiece and ...

Page 18: ...f recoverable after the test is completed According to the experienced clinician and those professionals who are capable of using specific device or system this risk is acceptable 17 1 Electromagnetic compatibility key components The electromagnetic compatibility key components of this product consist of power cord circuit board IC chip The use or replacement of non supporting accessories cables t...

Page 19: ... electromagnetic environment specified below The customer or the user of the model Endo 1 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 8 kV contact 2 kV 4 kV 8 kV 15 kV air 8 kV contact 2 kV 4 kV 8kV 15 kV air Floors should be wood concrete or ceramic tile If f...

Page 20: ...ruptions it is recommended that the model Endo 1 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 17 4 Guidance D...

Page 21: ... the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 3 5 V1 P1 2 d 1 2 P1 2 80 MHz 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 stre...

Page 22: ...hould be less than 3V m 17 5 Recommended separation distances between portable and mobile RF communications equipment and the model Endo 1 Recommended separation distances between portable and mobile RF communications equipment and the model Endo 1 The model Endo 1 is intended for use in electromagnetic environment in which radiated RF disturbances is controlled The customer or the user of the mod...

Page 23: ... propagation is affected by absorption and reflection from structures objects and people Endo 1 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 Avoid using the device in high electromagnetic environment 18 Statement Woodpecker reserves the righ...

Page 24: ...ZMN SM 190 V1 8 20201103 ...

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