Bomedent Actor I pro User manual

Ultrasonic Endo Activation Device
User Manual
Changzhou Bomedent Medical Technology Co., Ltd.

Thank you very much for choosing the Ultrasonic Endo Activation Device of
Bomedent
To give full play to the function of this device, and operate and maintain it
correctly and safely, please read this User Manual carefully before using it, and
keep this User Manual properly for reference at any time
Classification of device safety level:
Classification of electric shock protection type: Class II
Classification of electric shock protection level: Class B
Classification of liquid entry prevention level: IPX0
Sterilization or disinfection method: please refer to the cleaning and disinfection
section
Classified by the safety level in the case of using the product with flammable
anesthetic gas mixed with air or flammable anesthetic gas mixed with oxygen or
nitrous oxide: not to be used in the case of using the product with flammable
anesthetic gas mixed with air or flammable anesthetic gas mixed with oxygen or
nitrous oxide
Operation mode: intermittent load continuous operation

Contents
1. Product Introduction.............................................................................................................. 1
1.1 Brief Introduction............................................................................................................ 1
1.2 Model............................................................................................................................... 1
1.3 Scope of Application....................................................................................................... 1
1.4 Contraindications............................................................................................................. 1
1.5 Precautions for Use.......................................................................................................... 1
2. Product Configuration........................................................................................................... 3
2.1 External Structure of Main Frame of Product................................................................. 3
2.2 Main Accessories of Product........................................................................................... 3
2.3 Accessories List............................................................................................................... 4
3. User Interface ........................................................................................................................ 4
4. Product Installation................................................................................................................ 6
4.1 Installation of Silicone Case............................................................................................ 6
4.2 Installation of Working Tip............................................................................................. 6
4.3 Removal of Working Tip................................................................................................. 6
5. Product Use ........................................................................................................................... 7
5.1 Operation......................................................................................................................... 7
5.2 Charging.......................................................................................................................... 9
5.3 Wireless Foot Control.................................................................................................... 10
6. Troubleshooting................................................................................................................... 12
7．Cleaning, Disinfection and Sterilization.......................................................................... 13
7.1 Cleaning and Sterilization of Working Tip, Wrench and Silicone Case....................... 13
8. Storage, Maintenance and Transportation........................................................................... 15
9. Technical Parameters........................................................................................................... 16
10. Symbol Description........................................................................................................... 17
11. Environmental Protection.................................................................................................. 17
12. After-sales Service............................................................................................................. 17
13. EMC Statement ................................................................................................................. 18

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1. Product Introduction
1.1 Brief Introduction
Ultrasonic Endo Activation Device (hereinafter referred to as “Actor I pro” or
“device”) is an auxiliary device for dentists to perform root canal treatment. It is
mainly used to effectively clean the root canal with the help of ultrasonic cavitation,
so as to assist dentists to complete root canal treatment.
The features of this device are as follows:
a) The working process of this device is under full automatic control of
microchip, which is convenient and simple to operate;
b) The vibration amplitude of the working tip can be adjusted so as not to harm
the root canal, and its frequency can be dynamically adjusted to ensure cleaning
efficiency;
c) The working tip, silicone case and wrench can be sterilized by high
temperature and high pressure.
d) This device can be illuminated to make it clearer.
1.2 Model
Actor Ⅰ pro
1.3 Scope of Application
Intended use: for cleaning of the root canal area of teeth.
User: dentist
Use place: hospital or dental clinic
1.4 Contraindications
a) It is contraindicated by hemophiliacs, patients with cardiac pacemaker or
cochlear implant and doctors;
b) It should be used with caution on patients with heart disease, pregnant
women and young children
1.5 Precautions for Use
Please read this User Manual carefully before use.

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This device may not work properly due to the following environmental
factors:
1) Portable or movable radio frequency transmitters are present nearby.
2) Electromagnetic interference may cause abnormal operation of this device.
As with all electronic devices, this device has electromagnetic interference
and should not be used on patients with cardiac pacemaker.
During operation and cleaning, be sure to pay attention to the direction and
position of the working tip, so as not to hurt the patient and the operator.
Please fully check whether there is looseness, noise or heating on the
working tip. For any abnormal phenomenon, please stop using it and contact
the local distributor or manufacturer.
Please beware of collision, especially falling.
When the working tip and silicone case need to be removed, please turn off
the power first. So as not to accidentally touch the switch on the handle, thus
leading to its accidental starting and causing injury to human body.
When the battery on the screen displays flashing, please timely charge it.
When charging, please use the original power adapter.
Please use the original accessories. Accessories from other manufacturers
may make this device unusable or damaged.
Please do not disassemble and repair this device without permission,
otherwise it may automatically lose the warranty qualification.
Please do not place this device in a damp place or where it may come into
contact with any liquid.
Please do not expose this device to direct or indirect heat sources. This
device must be operated and stored in a safe environment.

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2. Product Configuration
2.1 External Structure of Main Frame of Product
2.2 MainAccessories of Product
Working tip Wrench Silicone case
Power adapter Power cord Charging base
Wireless foot switch (optional)

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2.3 Accessories List
Please see the packing list for the device configuration.
3. User Interface
①: switch button with built-in power indicator light
②: battery power indicator light and charging indicator light
③: bluetooth button with built-in bluetooth indicator light
④: illuminating light
⑤: Charging indicator light on charging base
Switch button
①
:
Power on: when the device is off, press and hold the switch button for 1 second,
and the device will enter the standby state with the ring tone;
Power off: in standby state, press and hold the switch button for 1 second, and the
device will be turned off with the ring tone.
Operation and stop: in standby state, press the switch button for 0.1 seconds, and
the device will enter the working state and start vibrating. Press the switch button

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again to stop working.
Power setting: press and hold the switch button for 1 second in the working state
to switch between "high" power and "low" power
Power indicator light:
Under "high" power: the power indicator light is always green;
Under "low" power: the power indicator light flashes in green
Battery power indicator light
②
Blue: it means that the battery power is above 50%;
Yellow: it means that the battery power is between 10% and 50%;
Flash in yellow: it means that the battery power is less than 10%, and the
battery should be charged in time;
Green: when the green light is always on, it indicates that the device is being
charged. When the device is fully charged, the green light will turn off
automatically.
Bluetooth button
③
Turn on bluetooth: when both the wireless foot switch and the device are in
standby state, press any button of the wireless foot switch first, and then press the
bluetooth button ③to open the bluetooth;
Turn off bluetooth: when the bluetooth is on, press the bluetooth button ③to turn
off the bluetooth;
Bluetooth indicator light:
The indicator light is always on in blue: it means that the bluetooth has been
turned on, but the device is not connected with the wireless foot switch;
The indicator light flashes in blue: it means that the device has been
connected with the wireless foot switch, and they can communicate normally;
The indicator light is off: the bluetooth is not turned on.
Illuminating light
④
This indicator light is always on when the device is working
Charging indicator light on the charging base
⑤
When the charging base is powered on, the charging indicator light on the

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charging base is always on in green;
When the main frame is placed on the charging base to charge: the charging
indicator light on the charging base is always on in blue.
4. Product Installation
4.1 Installation of Silicone Case
Align the silicone case with the head and gently put it on.
4.2 Installation of Working Tip
Align the thread on the working tip with the stud on the main frame, insert them
together to make sure the thread matches correctly, and rotate gently clockwise.
Align the wrench with the slot of the working tip, rotate the wrench clockwise,
and slowly apply force until the working tip is tightened.
After the working tip is tightened, deviation within 10° is normal.
Warning:
When installing the working tip, please ensure that the main frame is
powered off;
When the working tip is installed on the main frame, it will not become
loose or fall off to ensure that the working tip is firmly installed;
Before inserting the working tip, check the assembly interface between the
working tip and the main frame. Please do not use the damaged working tip
or device;
If the working tip is not firmly installed, it may lead to unpredictable rotation
or the working tip may fall off, and even hurt the patient.
Please use the original working tip;
The working tip has not been disinfected and sterilized before leaving the
factory. Please use it after sterilization;
After each treatment, the working tip should be cleaned, disinfected and
sterilized.
4.3 Removal of Working Tip
Align the wrench with the slot of the working tip, rotate the wrench

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counterclockwise to loosen the working tip, and continue to rotate the wrench until
the working tip comes out.
Caution:
The number of use of the working tip should not exceed 20 operations, with the
number of 2 root canals per operation as the reference.
Warning:
When installing or removing the working tip, please be careful not to injure
your finger;
When installing or removing the working tip, please make sure the main
frame stops working.
5. Product Use
5.1 Operation
Start the device: press and hold the switch button for 1 second, the device starts up
and enters the standby state.
Run the device: in standby state, press the switch button to run the device, the power
indicator light is on, the illuminating light opens, and the working tip begins to
vibrate.
Warning:
Once the device is started, please do not touch the working tip to avoid
scalding;
Please do not operate the device without flushing fluid in the root canal.
Make sure there is enough flushing fluid in the root canal for cooling during
the use of the device;
Caution:
Hold for 30 to 60 seconds at a time for a better cleaning effect.
Switch between "high/low" power working states: in the working state of the
device, press and hold the switch button for 1 second to switch between high and low
power working states. In the "high" power working state, the power indicator light is

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always on in green; in the "low" power working state, the power indicator light
flashes in green.
Stop working: when pressing the switch button in the working state, the working tip
will stop vibration, and the device will enter the standby state. The device will be
powered off automatically after standby for 1 minute. Be sure to remove the working
tip after the use of the device.
After 3 minutes of continuous working, the device will automatically turn off the
output and enter the standby state; in the course of operation, if the device stops
suddenly, restart the device. In addition, the device has the function of timing prompt,
and there is a prompt tone every 5s in the working process.
Warning:
Before using the device for treatment, try it out of the mouth to make sure
the device is functional;
The working tip may be damaged suddenly when it enters the root canal
which is too curved or not in good shape. If the user feels uncomfortable,
please stop using the device immediately.
Even in normal use, the working tip may be separated from the main frame
due to metal fatigue and wear. Please replace it in time. Please do not use the
working tip more than its recommended times of use.
When the working tip suffers excessive external force, it may break. When
using this device, please do not apply excessive external force to the
working tip.
Please do not disassemble the working tip during the treatment, because it
may scratch the operator or the patient.
Caution:
Please stop using this device when any abnormalities occur. This device is
not suitable for all types of root canals. Please do not use this device for
extremely deformed root canals.
Please use disposable gloves and rubber dam during treatment;

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Be sure to remove the working tip after each treatment.
5.2 Charging
Please use the charging base corresponding to this device for charging:
Insert the USB cable into the power adapter (Figure a);
Insert the USB cable into the charging base (Figure b);
Connect the USB cable to the charging base and turn on the power. Then put
the main frame of Actor I pro into the charging base for charging. When the
main frame is placed in the charging base for charging, the main frame will
be powered off automatically. The charging indicator light of the main frame
will always be on in green. If it goes off, the charging is completed. When
the charging base is powered on, the charging indicator light on the charging
base is always on in green, and when the main frame is placed on the
charging base, the charging indicator light on the charging base turns to be
on in blue. It is expected that the time for the device to be fully charged is
about 4 hours, which can guarantee the operation of the device in the state of
maximum power consumption for about 3 hours.
Figure a Figure b
Caution:
When the battery power indicator light flashes in yellow, accompanied by
the prompt tone, the battery power is low, and the device should be charged
in time;
The battery used in this product lacks of memory property and can be
charged at any time;
Please charge the device for at least 4 hours before the first charge;

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When the main frame is inserted into the charging base, but it does not enter
the charging state, please stop charging it immediately and then contact the
local distributor;
When charging with the charging base, please place the charging base or the
main frame in a dry and safe place where they are not easily knocked over;
Please use the power adapter and cable provided by the manufacturer for
charging;
After the battery is discharged completely, the battery may not be recharged,
thus causing it to be damaged. When the device is not used for a long time, it
should be fully charged every one to two months;
Do not place the charging base or main frame in dust, or especially in the
environment with metal debris. Please pay special attention to the protection
of charging port;
Please pull out the main frame vertically upward after full charge.
5.3 Wireless Foot Control
We always design the product from the perspective of the doctor's use to make its
operation easier. Actor I pro is a safe, accurate, compact and convenient product.
When a doctor performs root canal treatment on the molar teeth, they need to go deep
into the mouth, so it is inconvenient to press the buttons on the device. In order to
provide doctors with more convenient operation experience, we also provide an
optional wireless control solution. You can choose our wireless foot switch to achieve
this function.
Actor I pro can be connected wirelessly with our wireless foot switch through
bluetooth. After successful connection, the operation of Actor I pro can be controlled
within 5 meters.
Bluetooth connection setting of Actor I pro:
Step on any button of the foot switch to open the power supply of the foot switch;
Turn on the power of Actor I pro, press the bluetooth button ③, turn on the
bluetooth, and the indicator light is always on in blue; Actor I pro will
automatically search, pair and connect to the wireless foot switch.

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After the connection is successful, the bluetooth indicator light flashes. After
pressing and holding any button of the foot switch, Actor I pro starts to run;
release the button to stop its operation;
Caution:
Only when the wireless foot switch is in standby state, the bluetooth can be
turned on by pressing the bluetooth button of Actor I pro;
This device is only for one-to-one connection through bluetooth, that is, one
module can only be connected with one product;
When multiple devices are searching and pairing at the same time, the target
device may not be connected, so please pair it with one to one separately;
When turning on the bluetooth function, please stay away from other
bluetooth, WiFi and other 2.4G wireless products;
After successful bluetooth connection, the device information of the wireless
foot switch will be automatically saved in the internal storage space of Actor
I pro. This function is turned off by default.

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6. Troubleshooting
Fault
phenomenon Check items Fault analysis and handling method
Reference
chapter or
section
The device does
not work after
starting up
The battery power is low. Charge it in time. 5.2
The time to press the switch
button is too short Please press and hold the switch button 5.1
The device is
not charged
properly
The wrong power adapter is
used Please use the original power adapter 1.5
The charging base is not
powered on Please check the connection 5.2
The main frame is not
inserted into the charging
base properly
Please che
ck whether there is any
foreign body in the main frame 5.2
The working tip
fails to vibrate
1. The working tip is not
tightened;
2. The working tip is
damaged.
3. The main frame is
damaged
1. Tighten the working tip with a
wrench;
2. Replace the working tip with a new
one.
3. Please contact the distributor
4.2
The indicator
light on the
main frame is
not on
The main frame is damaged Please contact the distributor 3
The main frame
has not sound The mainboard is damaged Please contact the distributor 5.1
The main frame
gives an alarm
and the battery
power indicator
light is on
The battery power is low Please charge it in time 5.2

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7
．
Cleaning, Disinfection and Sterilization
Caution:
 No part of Actor I pro is sterilized before leaving the factory
Warning:
 Please do not soak the main frame in the ultrasonic cleaning machine
 It is recommended to use a soft cloth soaked in alcohol to wipe and disinfect the
surface of the main frame of Actor I pro;
 Please do not use liquid or spray cleaner directly on the main frame.
 Please do not disinfect the main frame by heating;
 Parts of the Actor I pro that can be sterilized include the working tip, wrench, and
silicone case
The work tip, wrench and silicone case have biocompatibility (in line with
standard EN ISO 10993-1). The work tip, wrench and silicone case must be sterilized
before they are used for each patient. High temperature and high pressure steam
sterilization method is recommended. The recommended high temperature and high
pressure steam sterilization parameters are as follows:
a) Perform steam sterilization at 134℃for 5 minutes (placed in a sterilization
bag). The sterilization temperature should not exceed 135℃. The steam sterilizer shall
be used in accordance with Standard EN 13060.
b) The working tip, wrench, and silicone case can be repeatedly sterilized.
Warning:
 Except for the above mentioned working tip, wrench, and silicone case, no other
parts of Actor I pro can be sterilized
 Do not sterilize by heating, radiation, formaldehyde, ethylene oxide and plasma.
7.1 Cleaning and Sterilization of Working Tip, Wrench and Silicone Case
1) Cleaning
Steps Parameters
1.
Wash
Wash the working tip, wrench and silicone case with running water for 2 minutes to remove their
surface contaminants.

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2.
Wipe
Wet the soft clean cloth in the cleaner, and then use it to wipe the surface of the working tip,
wrench and silicone case thoroughly 5 times. Replace it with a new one after each wipe. If there
are still visible contaminants, wipe repeatedly until no contaminants are visible to naked eyes.
3.
Scrub
Scrub the working tip
, wrench and silicone case thoroughly for 3 minutes with an instrument
brush with cleaner.
4. Soak Soak the working tip, wrench and silicone case in the cleaner for 5 minutes.
5.
Rinse
Rinse the working tip, wrench and silicone case with purified water f
or 2 minutes to remove
residual cleaner on its surface.
6. Dry
Use a dry, absorbent and soft cloth to wipe the residual water on the surface of the working tip,
wrench and silicone case.
2) Sterilization
Steps Parameters
Sterilize
Put the cleaned working tip, wrench and silicone case into the disposable sterilization bag. The
sterilization temperature should be 134℃. The sterilization time should be 5 minutes. The
pressure should be 205.8kPa.

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8. Storage, Maintenance and Transportation
1. Storage
a. This product should be handled with care, kept away from earthquake source,
and stored in a dry and ventilated place.
b. This product should not be placed together with toxic, corrosive, flammable
and explosive items.
c. The relative humidity of the storage environment should be 10%~80%, the
atmospheric pressure should be 500-1060hPa, and the temperature should be
-10℃~ +50℃.
2. Maintenance
a. This product does not contain self-repair spare and accessory parts. Repair of
this product should only be carried out by specialized maintenance personnel
or special repair shops.
b. Please keep this product dry. Rainwater, moisture and liquids may contain
minerals that can corrode the electronic circuit of this product.
c. Do not throw, knock or vibrate this product. Rough handling of this product
may damage its internal circuit board and wires.
d. Do not apply paint to this product, as it will leave debris in the removable
parts, thus affecting its normal operation.
3. Transportation
a. During the transportation, excessive impact and vibration should be
prevented. Handle it with care. placing it upside down should be avoided.
b. This product should not be transported together with dangerous goods.
c. This product should not be exposed to the sun, rain or snow during
transportation.

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9. Technical Parameters
Manufacturer
Changzhou Bomedent Medical Technology Co., Ltd.
Product name
Ultrasonic Endo Activation Device
Model
Actor Ⅰpro
Dimensions Main frame: 169*26*28mm
Charging base: 82*64*73 mm
Weight
700g
Power supply mode
Lithium battery, DC 3.7V, 1600mAh
Charging base Input: DC5V/1A
Output: DC 5V, 0.5A max
Power adapter Input: AC100-240V, 50/60Hz 0.15A max
Output: DC5V/1A
Liquid permeation
protection
IPX0
Classification of electric
shock protection type
Class II, Internal power unit
Classification of electric
shock protection level
Class B
Main vibration offset of
working tip
<100μm
Vibration frequency of
working tip
45kHz±5kHz
Effective connection
range of bluetooth
≤5m
Power consumption
<3W
Use environment
Temperature: 10-40℃
Humidity: 10-70%
Atmospheric pressure: 700-1060hPa
Storage/transportation
environment:
Temperature: -10-50℃
Humidity: 10-80%
Atmospheric pressure: 500-1060hPa
Expected service life 4 years

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10. Symbol Description
Refer to the user manual
Warning: please read this manual
before use
Type B application device Class II device
The product complies with the
directive on WEEE. This device
must be disposed of as municipal
solid waste when abandoned
Serial number
Manufacturer Date of manufacture
For indoor use Upward
Damp-proof Fragile. Please handle it with care
11. Environmental Protection
This product does not contain harmful ingredients and can be disposed and
destroyed according to the relevant local regulations.
12. After-sales Service
Since the date of sale, if this device cannot work normally due to quality
problems, it can be repaired by our company or the designated agent by showing your
warranty card. Please refer to the warranty card for warranty period and scope.