Guilin Woodpecker Medical Instrument Endo 3 User manual

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-------------------------------------------------- 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

1
Preface
Guilin Woodpecker Medical Instrument Co., Ltd is a professional
manufacturer researching, developing, and producing dental products.
Woodpecker owns a sound quality control system. Its main products
include Ultrasonic Scaler, Ultrasonic Endo Ultrasonic Endo Activate Device,
Curing light, Apex locator, Ultrasurgery, Automatic water supply system,
etc.
1 Product introduction
1.1 The features of Endo 3 Ultrasonic Endo Activate Device
a) Adopt microcomputer automatic control for the working process, which
makes the operation easier and efficient. There are one mode switching
button and a switch ring button. Press the mode switching button to adjust
the working state of the machine, and press the switch ring button to start
or shut down the machine.
b) This machine has three modes: shutdown mode, hot standby mode (in
this mode, power adjustment and time adjustment can be carried out) and
irrigation mode (working mode).
c) The machine has stable performance and adopts an automatic
frequency tracking system to automatically search for the best working
state.
d) The tips, Endo wrench and protective silicone cover can be autoclaved
under high temperature of 134°C and high pressure of 0.22Mpa.
e) The small vibration amplitude and high frequency of the tip enable the
efficient and safe irrigation.
1.2 Product model
Endo 3
1.3 Product principle and scope of application
1.3.1 Product principle
Endo 3 Ultrasonic Endo Activate Device mainly generates high-frequency
oscillating signals from the high-frequency oscillating circuit and acts on the
ultrasonic transducer. The ultrasonic vibration is generated by the inverse
piezoelectric effect, and the tip is stimulated to generate resonance. It can
deep into the root canal and utilizes various effects produced by ultrasonic
waves to drive the drug or liquid in the root canal, generating ultrasonic
flow and cavitation effects, and achieving the effect of irrigating stains and
debris.
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

2
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
Nominal voltage: 3.6V
Capacity: 750mAh
3.6 Power adapter:
Input: 100V-240V~ 50Hz/60Hz 0.4A MAX
Output: DC 5V/1A
Build-in fuse: T1AL 250V
3.7 Working tip parameters:
Output tip vibration frequency: 40kHz±10kHz
3.8 Software Version:V1.0.0
3.9 Environment parameters:
Environment temperature: +5°C ~+40°C

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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.
3.10.5 The temperature of the surface of applied part may reach 48℃.
3.10.6 Degree of protection against electric shock: BF type applied part
3.10.7 Degree of protection against harmful ingress of water: Ordinary
equipment (IPX0)
3.10.8 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
Before use: Install the disposable isolation sleeve first, then install the
protective silicone cover, and finally install the tip.
After use: First remove the tip, then remove the protective silicone cover,
and finally remove the disposable isolation sleeve.
4.1 Installation and removal of disposable isolation sleeve
4.1.1 Installation
Before each use of the host and after the host is cleaned and disinfected,
put on a disposable isolation sleeve. Take the isolation sleeve out of the
isolation sleeve box, then insert the isolation sleeve into the host from the
thin end of the host, and install the isolation sleeve until there is no obvious
wrinkle.
4.1.2 Removing
After each use, slowly pull the isolation sleeve from the thin end of the
host.
Warning: Isolation sleeves are not reusable.
4.2 Installation and removal of protective silicone cover
4.2.1 Installation
Before each use of the host, put on a sterilized protective silicone cover.
Align the protective silicone cover with the head of the host and put it on
gently.
4.2.2 Removal
After each use, slowly remove the protective silicone cover from the host.
4.3 Installation and removal of the tip

4
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.
Tighten clockwise to install the tip Unscrew counterclockwise to remove the tip
4.4 For battery charging, plug the host into the charging base and press
tightly to make the host and base tightly match. While not charging, please
keep the charging base power off.
5 Operation
Buttons and screen display:
5.1 Under the shutdown mode of the host, press the mode switching
button lightly and the host would enter the hot standby mode. Under
the hot standby mode, lightly press the mode switching button to select
the power level of the host. After selecting the power, press the mode

5
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
state.
5.2 When using, first inject the liquid medicine into the root canal, next set
the power level and the irrigation time of the host, then put the tip into the
appropriate position of the root canal, lightly press the ring switch button
of the host, and the host will automatically adjust to the best working
condition for work. After the irrigation, press the ring switch button to stop
irrigation (or the host will stop irrigation after the irrigation time is over). After
replacing the liquid medicine, lightly press the ring switch button again to
re-enter the irrigation mode. In general, a complete root canal irrigation
requires replacing the liquid medicine 7-8 times.
5.3 After the treatment, long press the mode switching button and the host
would enter the shutdown mode.
5.4 The tip and Endo wrench can be autoclaved under high temperature
of 134°C and high pressure of 0.22MPa.
5.5 Low voltage indication: If the screen shows that there is only 1 grid
voltage left, it means that the battery is about to be exhausted and needs
to be charged as soon as possible.
6 Charging instructions
6.1 Use the charging base corresponding to this machine to charge:
Connect the power adapter to the charging base and turn on the power,
and then put the main unit of Ultrasonic Endo Activator on the charging
base. When charging, the battery indicator on the screen will continue
to flip. When the indicator stops at 4 grids position and stops flipping, it
means charging is finished. Under normal circumstances, it takes 4 hours
to charge. When fully charged, the machine can continue to work for 1
hours.
6.2 The battery used in this product has no memory and can be charged
at any time.
6.3 Before first use of this machine, please charge for at least 4 hours.
7 Safety precautions
7.1 A tip engraved with the "WOODPECKER" logo cannot be used on a
host engraved with the "DTE" logo and vice versa.
7.2 Keep the machine clean before and after operation.
7.3 Operators should be equipped with adequate protections such as

6
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.
7.6 Please install or remove the tip under shutdown mode.
7.7 The tip must be tightly screwed.
7.8 During operation, it is necessary to drip water for cooling. At the same
time, the water dripping instrument needs to be isolated from the earth.
7.9 The damage or wear of working tip will result in vibration intensity
decrease. The operator should replace the work tip according to the clinical
situation.
7.10 Don’t twist or polish work tip.
7.11 Don’t strike or scratch the host.
7.12 When charging with the adapter, keep the contact with the adapter
housing for less than 1 min.
7.13 Please long press the mode switching button to make the host enter
the shutdown mode after each treatment.
7.14 Replacement of lithium batteries by inadequately trained personnel
and incorrect replacement of lithium batteries could result in a HAZARD,so
please contact local distributors to replace the battery if necessary.
7.15 The adapter plug can be used to disconnect from the network
power supply.Don't position the device to make it difficult to operate the
disconnection device.
7.16 Woodpecker is specialized in producing medical instrument. We are
only responsible for the safety on the following conditions:
a) The maintenance, repair, and modification are made by the manufacturer
or the authorized dealers.
b) The charged components are original of “DTE or Woodpecker” and
operated according to instruction manual.
7.17 The internal thread of Ultrasonic Endo activating file produced by
some 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 host, resulting in damage beyond repair of
the Ultrasonic Endo activating file. Please use “DTE or Woodpecker” brand
work tips.
7.18 HAZARDS that can result from unauthorized modification of the
device.
8 Product contraindications
8.1 The hemophilia patient is forbidden to use this equipment.
8.2 The patients with heart pacemaker are forbidden to use this equipment.

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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.
Unless otherwise stated, they will be hereinafter referred to as “products”.
Warnings
The use of strong detergent and disinfectant (alkaline pH>9 or acid pH<5)
will reduce the life span of products. And in such cases, the manufacturer
takes no responsibility.
The products may not be exposed to temperature above 138°C.
Processing limit
The products have been designed for a large number of sterilization cycles.
The materials used in manufacture were selected accordingly. However
with every renewed preparation for use, thermal and chemical stresses will
result in ageing of the products. The maximum number of sterilizations for
tips is 300 times. For wrench, it is 1000 times. And for protective silicon
cover, it is 300 times.
9.1 Initial processing
9.1.1 Processing principles
It is only possible to carry out effective sterilization after the 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.
9.1.2 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. Wet the soft cloth completely with distilled water or deionized water,
and then wipe all the surfaces of the 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 clean tray.
Notes:

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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.
2. Remove the protective silicon cover from host and put it into the tray.
3. Remove the disposable isolation sleeve from host.
Disassembling steps
9.3 Cleaning
The cleaning should be performed no later than 24 hours after the
operation.
The cleaning can be divided into automated cleaning and manual cleaning.
Automated cleaning is preferred if conditions permit.
9.3.1 Automated cleaning
• The cleaner is proved to be valid by CE certification in accordance with
EN ISO 15883.
• There should be a flushing connector connected to the inner cavity of the
product.
• The cleaning procedure is suitable for the product, and the irrigating
period is sufficient.

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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.
b) In 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 in accordance with the
cytotoxicity test.
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. Start the program.
3. 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").
The intrinsic suitability of the product for effective cleaning and disinfection
using the above automated cleaning and disinfection procedures was
verified by a certified facility. (Use the G 7836 CD washer disinfector,
Miele & Cie. KG, Gutersloh,(thermal disinfection), and the cleaning agent
neodisher MediZym (Dr. Weigert)).
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

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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 is cold deionized
water. (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) For the disinfection here, the temperature is 93 °C, the
time is 5 min, and A0>3000.
e) Only deionized water with a small amount of microorganisms (<10 cfu/
ml) can be used for all rinsing steps. (For example, deionized water that
is in accordance with the European Pharmacopoeia or the United States
Pharmacopoeia).
f) After cleaning and disinfection, the chemical residue should be in
accordance with the cytotoxicity test.
g) The air used for drying must be filtered by HEPA.
h) Regularly repair and inspect the disinfector.
9.5 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). Until no liquid is
sprayed onto the white paper (white cloth), the product drying is completed.
2. It can also be dried directly in a medical drying cabinet (or oven). The
recommended drying temperature 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.
9.6.1 Check the product. If there is still visible stain on the product after
cleaning/disinfection, the entire cleaning/disinfection process must be
repeated.
9.6.2 Check the product. If it is obviously damaged, smashed, detached,
corroded or bent, it must be scrapped and not allowed to continue to be
used.

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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.
9.6.5 If necessary,please contact your local dealer for replacement
or maintenance.We will make available on request circuit diagrams,
component part lists,etc.that will assist local dealers to repair the device.
9.7 Packaging
Install the disinfected and dried product and quickly package it in a medical
sterilization bag (or special holder, sterile box).
Notes
a) The package used conforms to ISO 11607;
b) It can withstand high temperature of 138 °C and has sufficient steam
permeability;
c) The packaging environment and related tools must be cleaned regularly
to ensure cleanliness and prevent the introduction of contaminants;
d) Avoid contact with parts of different metals when packaging.
9.8 Sterilization
Use only the following steam sterilization procedures (fractional pre-
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;
• The highest sterilization temperature is 138 °C;
• The sterilization time is at least 5 minutes at a temperature of 134 °C.
• Allow a maximum sterilization time of 20 minutes at 134 °C.
Verification of the fundamental suitability of the products for effective steam
sterilization was provided by a verified testing laboratory. (Used the Systec
DX-150 Middle-sized hospital moist heat sterilizer, MMM GmbH, Eurofins
Munich ).
Notes
a) Only products that have been effectively 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 sterilize with other sterilization procedures such
as ethylene oxide, formaldehyde and low temperature plasma sterilization.
The manufacturer assumes no responsibility for the procedures that have

12
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.
9.9 Storage
1. Store in a clean, dry, ventilated, non-corrosive atmosphere with a relative
humidity of 10% to 93%, an atmospheric 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
regularly;
b) Product storage must be batched and marked and recorded.
9.10 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.
The cleaning and disinfection of host and base are as follows.
1 Pre-Op processing
Before each use, the host must be cleaned and disinfected. The specific
steps are as follows:
Warning: The host cannot be cleaned and disinfected with automatic
equipment. Manual cleaning and disinfection is required.
1.1 Manual cleaning steps:
1. Wet the 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 75% alcohol
2. Wipe all surfaces of host with a wet soft cloth for at least 3 minutes.
3. Wipe the surface of the host with a dry soft nap-free cloth.
Note:

13
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.
d) After cleaning and disinfecting the host, you must install a disposable
isolation sleeve before use. (For detailed installation steps, see section 4.1)
2 Post-Op processing
After each use, clean and disinfect the host and base within 30 minutes.
The specific steps are as follows:
Tools: Nap-free soft cloth, tray
1. Remove the protective silicon cover from the host, place it in a clean
tray, and then remove the disposable isolation sleeve from the host.
2. Soak the nap-free soft cloth with distilled water or deionized water, and
then wipe all the surfaces of the components such as the host, tip, etc.
until the surface of the component is not stained.
3. Remove the tip from the host, place it in a clean tray.
4. Wet the dry soft cloth with 75% alcohol, and then wipe all surfaces of
the host for 3 minutes.
4. Put the host back into the clean storage area.
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 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 Endo wrench, protective silicon cover and tips
can be sterilized under high temperature of 134°C and high pressure of
0.22MPa. For the other spare parts, they can be cleaned or sterilized by
using water or disinfectant to scrub their surface. Do not soak them in the
solution. Do not use volatile and diffluent solvent to clean as it will result in
the color fading of the marks on machine.
10.3 Please turn off the power switch, unplug the power plug when the
device is not in use. If not use for a long time, please make the device get
through to the power for five minutes once per month.

14
11 Troubleshooting
Fault Possible cause Solution
No indication; no action
The battery capacity of
Endo 3 Ultrasonic Endo
Activate Device is low.
Connect the power
supply to charge /
replace the battery
The battery is damaged. Replace the battery
Continuously using for a l
o n g t i m e , t h e r m a l
protection circuit action.
Stop using for few
minutes, and then it will
function normally.
Charging interface short
circuit results in lithium
battery getting into
protection state.
Plug the device into the
charging base to charge,
and it will function
normally.
Endo 3 Ultrasonic Endo
Activate Device is broken.
Contact with local dealers
or manufacturer.
Tips abnormally 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 shorter time after
charging
Battery capacity
becomes smaller
Send to maintenance
department
12 Storage and transportation
12.1 The equipment should be handled carefully and lightly. Be sure that it
is far from the vibration, and installed or kept in a cool, dry, and ventilated
place.
12.2 Do not store the machine together with articles that is poisonous,
combustible, caustic, or explosive.
12.3 This machine should be stored in a room where the relative humidity
is10%～93%, atmospheric pressure is 70kPa～106kPa, and the
temperature is -20°C～+55°C.
12.4 Excessive impact and shake should be prevented during
transportation. Lay it carefully and lightly.

15
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.
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
Date of manufacture CE marked product
BF type applied part Class II equipment
Ordinary equipment Anti-drip device
Serial number Used indoor only
Manufacturer Mode switching button
Products comply with
WEEE directive 5V Direct current
Sterilizable up to the
temperature specified
Follow instructions for
use
Keep dry Handle with care
Recovery Do Not Reuse
Ring switch button

16
Humidity limit for storage: 10% ~ 93%
Atmospheric pressure for storage: 70kPa—106kPa
Temperature limit for storage: -20°C ~ +55°C
Authorised Representative in the EUROPEAN COMMUNITY
17 Electromagnetic compatibility
Attention:
1) Without Woodpecker agreement and authorization, private modification
of device may result in the electromagnetic compatibility problem of that
device or other devices.
2) The design and test of Endo 3 Ultrasonic Endo Activate Device
complies with the related operation regulations of electromagnetic
compatibility.
Note: In the case of an electrical fast transient burst test, there may be a
situation in which the power cannot be adjusted due to the interference of
the touch key. This does not affect the output of the whole power and is
self- 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, transducers, etc. will result in a
significant reduction in electromagnetic compatibility emission and immunity
performance. Please do not privately replace the machine parts.
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.
Emmission test Compliance Electromagnetic environment – guidance

17
RF emissions GB
4824 Group 1
Endo 3 Ultrasonic Endo Activate Device
use 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 device.
Conducted
emissions
GB 4824
Class B
Endo 3 Ultrasonic Endo Activate Device
is suitable for being used in domestic
establishment and in establishment that is
directly connected to a low voltage power
supply network which is for domestic power
supply.
Harmonic
emissions GB
17625.1
Not
applicable
Voltage
fluctuations/ flicker
emissions
GB 17625.2
Compliance
17.3 Guidance and manufacturer’s declaration – electromagnetic immunity
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.
Immunity test IEC 60601
test level
Compliance
level
Electromagnetic
environment – guidance
Electrostatic
discharge (ESD)
lEC 61000-4-2
±6kV Contact
discharge
±8kV Air
discharge
±6kV contact
discharge
±8kV Air
discharge
Floors should be made of
wood, concrete or ceramic
tile. If floors are covered
with synthetic material, the
relative humidity should at
least reach 30%.
Electrical fast
transient bursts
GB/T 17626.4
±2kV For power
supply lines
±1kV For Input/
Output lines
±2kV For
power supply
lines
±1kV For
interconnecting
cable
Mains power should be
of the quality to be used
in commercial or hospital
environment.
Surge
GB/T 17626.5
±1kV Line to line
±2kV Line to
earth
±1kV Line to
line
Mains power should be
of the quality to be used
in commercial or hospital
environment.

18
Voltage
dips, short
interruption
and voltage
variations on
power supply
input lines.
GB/T 17626.11
＜5%UT, (＞
95% dip in UT)
for 0.5 circle
40%UT, (60%
dip in UT) for 5
circles 70%UT,
(30%
dip in UT) for 25
circles
＜5%UT, (＞
95% dip in UT)
for 5s
＜5%UT, (＞
95% dip in UT)
for 0.5 circle
40%UT, (60%
dip in UT) for 5
circles 70%UT,
(30%
dip in UT) for
25 circles
＜5%UT, (＞
95% dip in UT)
for 5s
Mains power should be
of the quality to be used
in commercial or hospital
environment. If the user of
Endo 3 Ultrasonic Endo
Activate Device requires
continued operation during
power mains interruptions,
it is recommended that
the Endo 3 Ultrasonic
Endo Activate Device be
powered from an
uninterruptable power
supply or a battery.
Power
frequency
magnetic field
(50/60Hz) GB/T
17626.8
3A/m 3A/m
Power frequency magnetic
field should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Note: UT is the alternative current mains voltage prior to application of the test
level.
17.4 Guidance and manufacturer’s declaration – electromagnetic immunity
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.
Immunity test IEC 60601
test level
Compliance
level
Electromagnetic environment
- guidance