Bomedent iRoot pro User manual

Operation Manual for iRoot pro
Endo motor for root canal preparation
with integrated apex locator.
Read this Operation carefully before use. Keep this Operation
Manual for future reference.


1
Thanks you for purchase of the Endo Motor with integrated apex locator.
Read this Operation Manual carefully before use for operation
instructions and care and
maintenance guidelines. Keep this Operation Manual for future reference.
Please do not hesitate to contact manufacturer for help with any doubt or problem that may
arise during consultation of this manual.
Consult accompanying documents (user manual)
This symbol, found on the labels of the unit and accessories, reminds the user to consult this
User Manual.
Intended use
This device
is a cordless micro-motor used primarily for mechanical root canal
preparation with integrated apex locator for endodontic treatment. While root canal
preparation is made, the root canal
measurement
can be simultaneously carried out.
Alternatively, the Independent apex locator measurement is possible, using the separate
file clamp for measuring file.
User
This device is only allowed to be used in hospital environments, clinics or dental offices by
qualified dentists and other legally licensed professionals. Do not use this device for anything
other than its specified dental purpose.
Prohibition
The product cannot be used to expand the grossly twisted root canal;
The product cannot be used for treatment other than implantation or other root canal therapy;
Hemophilia patients, patients with pacemakers and doctors are prohibited;
Patients with heart disease, pregnant women and young children are cautious.
Classification of Devices
Classification by type of protection against electric shock
-
Class
Ⅱ
devices
Classification by degree of protection against electric shock
-
Applied part type B
Classification by sterilization or disinfection method allowed by the
manufacturer
-
Refer to Sterilization
Classification by mode of operation
-
Continuously operating device

2
Symbols:
This conforms to CE European Directive
Follow the waste of electric and electronic equipment (WEEE) Directive to dispose of the
product and accessories.
ClassⅡequipment
Type B applied part
Refer to the instruction Manual
Consult accompanying documents (user manual)
Manufacturer Serial number Direct current
Date of manufacture Authorized representative in the
European Community

3
Table of Contents
1. General Precautions...............................................................................................................................................4
1.1 General Warnings and Conditions for Operation.........................................................................................4
2. Getting Started.......................................................................................................................................................6
2.1 Functions description and installation.........................................................................................................6
2.2 Discription of each part and its accessories.................................................................................................8
2.3 Installation contra angle ..............................................................................................................................8
2.4 Mounting and Removing File......................................................................................................................9
2.5 Charging......................................................................................................................................................9
3. Description of user-interface................................................................................................................................10
3.1 Keypad and Display..................................................................................................................................10
4. Operations
...........................................................................................................................................................13
4.1 QS (Quick Start ON/OFF KEY function)
..............................................................................................13
4.1.1
QS quick start key using ...............................................................................................................13
4.1.2 QS quick start key setting
...........................................................................................................13
4.2 Integrated Apex Locator............................................................................................................................14
4.2.1 Four working mode .......................................................................................................................14
4.2.2 Useful tips for accurate length determination
............................................................................15
4.2.3 Optional Apical Line
...................................................................................................................15
4.2.4 Operation of Apex Locator—Auto Start, Auto reverse exit
......................................................16
4.3 Rotation and settings in different modes
................................................................................................18
4.3.1
Rotation in different modes
.........................................................................................................18
4.3.2 Rotation Mode setting
.................................................................................................................19
4.4 Speed, Torque Settings
............................................................................................................................19
4.5 Convenient function
................................................................................................................................20
4.5.1 Program
........................................................................................................................................20
4.5.2 Alarm Sound Setting
...................................................................................................................20
4.5.3 OTR Settings (Normal reciprocating mode)
..............................................................................20
4.5.4 Wireless Transmission (Optional)
..............................................................................................20
4.5.5 Factory Default Parameters
.........................................................................................................21
4.5.6 Left-hander & Right-hander setting
...........................................................................................22
4.5.7 Auto Calibration setting.................................................................................................................22
5. Cleaning, Disinfection
.......................................................................................................................................23
6. Maintenance.........................................................................................................................................................24
6.1 Change battery ..........................................................................................................................................24
6.2 Lubricating contra angle............................................................................................................................24
7.
Technical Specification
......................................................................................................................................25
8. Error code ............................................................................................................................................................26
9. Troubleshooting...................................................................................................................................................26
10. Disposing Product
...........................................................................................................................................28
11. Warranty
............................................................................................................................................................28
12. Electromagnetic emissions and immunity
......................................................................................................28
Warranty Card
........................................................................................................................................................33

4
1. General Precautions
Most operation and maintenance problems result from insufficient attention being paid to
basic safety precautions and not being able to foresee the possibilities of accidents.
Problems and accidents are best avoided by foreseeing the possibility of danger and
operating the unit in accordance with the manufacturer’s recommendations.
Warning:
If the instructions are not being followed properly, operation may result in hazards for the product or
the user/patient.
Note:
Additional information, explanation on operation and performance.
1.1 General Warnings and Conditions for Operation
Warning: CONTRAINDICATION
Use of the device is contraindicated in patients and in users with pacemaker!
General Warnings
Use the specified battery for this product. Never use any other battery than manufacturer
specifies
High pressure from the outside will cause a liquid leakage or explosion
Keeping the central unit away from water, high-temperature and chemical solution which may
cause short circuit, fire, and other dangerous environment.
Sterilizing the motor by heat or steam may cause a liquid leakage or explosion.
Do not disassemble the central unit.
The product is used for dental treatment only by qualified personnel.

5
Conditions for Operation
This equipment is for indoor use only.
Environment temperature: 10-40℃.
Relative humidity: 10-70% (Non condensing).
The accuracy of the torque, rotation speed and apical position is guaranteed only when the
original contra angle is used which is supplied by manufacturer.
Do not sterilize the central unit, nor place it into autoclave or ultrasonic tank.
Do not use the system in the presence of free oxygen or flammable gas mixtures.
Portable and mobile RF communications equipment can affect Medical Electrical equipment.
Do not use RF equipment outskirts for the product.
Follow the instruction of file manufacture to set the rotation and speed of the motor.
If the Central unit has not been used for long time, check it before use
There is electric circuit which control the torque (TORQUE LIMITER Function) to prevent
files from breaking; however, files may still break due to metal fatigue if the torque is
conditioned to be higher. Please check the working instruction of file before use.
The battery charger must be supplied at a voltage in the range: 100V-240V (+/-10%), 50-60Hz
(+/-10%). Use only original parts.
Should any anomalies arise during operation, suspend work and contact your technical service
center.

6
2. Getting Started
2.1 Functions description and installation
Apex locator and Endo motor collaborative working function
Automatically rotate when entering the root canal
Automatically slow down when approaching to the apical
Automatically reverse when reaching the apical
Automatically stop when exiting the root canal
The device automatically identifies whether the lip hook cable is inserted
Inserting the lip hook cable means that the user needs to start the root canal measurement and
root canal preparation at the same time.
Apex locator function
When start only apex locator mode, the user can insert the measuring cable to start root canal
measurement.
Endo motor function
Quick start
User program
Forward (Auto reverse)
Reverse
Optimum Torque Reverse (Reciprocating)

7
Smarter Mode
———————————Notice————————————
——————————————————————————
The default setting in the quick start mode is: Machine standby in Reciprocating mode
I—Rotation in Reciprocating mode I—Standby in Reciprocating mode II —Rotation in
reciprocating mode II, in sequence.
Machine standby in (Reciprocating/Clockwise Rotation/Anti-Clockwise Rotation) mode
I—Rotation in (Reciprocating/Clockwise Rotation/Anti-Clockwise Rotation) mode I, standby
in (Reciprocating/Clockwise Rotation/Anti-Clockwise Rotation) mode II, Rotation in
(Reciprocating/Clockwise Rotation/Anti-Clockwise Rotation) mode II, in sequence.
Operation setting details, please refer to 4.1.2.
When the motor is in quick start mode, you can long press “P” to
change the reciprocating speed and direction.
Second press “ ”, rotation in
reciprocating mode I.
Third press “ ”, standby in
reciprocating mode II.
First press
“ ”
, standby in
reciprocating mode I.
Forth press “ ”, rotation in
reciprocating mode II.
Power off

8
2.2 Discription of each part and its accessories
The iRoot pro system is made up of the components listed below:
Components
Type
Number
Central Unit
iRoot pro
1PC
Contra angle
BMCA0001
1PC
Contra angle sleeve
BMCA1001
3PCS
Spray nozzle
BMSN0001
1PC
Measuring cable A
BMMV2001
1PC
Measuring cable B
BMMV1001
1PC
Lip hook
BMLH0001
3PCS
File clamp
BMFC0001
1PC
Power Adaptor
BMPA0001
1PC
USB cord
BMUC0001
1PC
Battery charger
BMBC0001
1PC
Operation manual
\
1PC
Wireless Pedal (optional)
BMWP0001
1PC
Remarks:
Measuring cable A to connect lip hook and file clamp (for only apex locator mode)
Measuring cable B to connect lip hook (Apex locator control motor mode, or separately working
together)
2.3 Installation contra angle
The contra angle can be connected with the
central unit
at 6 adjustable head positions. Align
the
positioning pins of the contra angle with the positioning slots of the
central unit
and insert the
head until
they click. When removing the
contra angle head, pull it out axially.
Central Unit
Contra angle
Spray nozzle
Contra angle sleeve
Power Adaptor
Lip hook
USB cord
Battery charger
Measuring cable B
Measuring cable A
File clamp

9
Warning:
Turn off the power to remove or attach the contra angle
Do not use the contra angle other than manufacturer specifies
Check that the contra angle is securely connected to the central unit
2.4 Mounting and Removing File
Mounting: Insert file to contra angle, lightly turn
the file until it engages with the
latch mechanism.
Removing: Press the push-key and pull out the file
2.5 Charging
a) Insert the power cord jack into the inlet at the back of the battery
charger.(Fig. a)
b)
Insert the power cord andplug in. Makesure you have the correct
model.(Fig. b)
c) Turn on the power switch. At this time, check that the power lamp
lights up.
d) Insert the central unit into the battery charge. Charging
starts with the charge mark flashing on oled
screen. (Fig.c) When the buzzer sounds and is played on the oled screen, charging is completed.
The central unit can be charged directly by USB cable.
Please ensure the central unit and the battery charger is placed in dry and clean condition.
Never use the battery charger for anything other than the device of this product by
manufacturer.
The charging normally takes approx. 90 minutes, but it depends on battery use conditions,
battery freshness, ambient temperature, etc.
Under the charging condition, the central unit was not allowed to rotate.
The completely discharged will cause the damage of the battery. The user should charge the
battery completely once a month if the central unit will not be used for long term.
Pull out the central unit from the charger base up straightly after the battery fully charged.
Warning:
When the central unit is charging, but the buzzer does not sound and the charging animation is
not displayed, please take the central unit out from the battery charger, check the ”ERROR
CODE” to find out the problem.

10
3. Description of user-interface
3.1 Keypad and Display
- KEY
Meter
The "Apex" icons
flashes when the file
tip is beyond the
root apical point.
Apex working
length indicator
bars
+ KEY
The meter’s 0.5 reading indicates
that the tip of the file is in or very
near the apical. * The numerals on
the meter gauge do not represent
millimeters. The”◁” icons flashes
when the file tip is beyond the root
apical point.
ON/OFF KEY
SELECT KEY
Program No
*Speed=Rotation speed of
the file
Digital display
Independent apex locator
Battery
Indicator
OLED Screen
PROGRAM KEY
Wireless
transmission
Alarm
Symbol
Working mode
Speed
Torque
Rotation Mode
POWER KEY
<OLED Screen>
Speed display
Independent endo motor
Torque display, the
column bar reflects
the actual torque in
real time.

11
POWER Key ( )
The POWER key: long press power key to turn on or turn off the motor.
ON/OFF ( )
Normal rotation operation: when the power is on
-
Pressing this key to start the motor and pressing this key again to stop the motor.
QS (Quick Start Key): when the power is off, press this key to enter in the quick start mode.
SELECT Key ( )
Torque, Rotation, Working mode setting and other operation setting.
1) Short press this key to set torque, rotation and working mode, when the machine is on.
To adjust the settings in the select box by “+/-” key, the sequence are as follows
“Torque—Rotation—Working mode”, the setting will be saved automatically, to press “P”
to exit.
2) Long press this key to start other operation setting, when the machine is on.
To adjust the icon of “Volume—Reciprocating—Apex—Bluetooth—Factory
Default—Left-Hander & Right-Hander—Auto Calibration” by “+/-”key, the settings will be
saved automatically, and press “P” to exit.
PROGRAM Key ( )
A program can be selected
QS( Quick Start Key) setting(The details to see “ 4.1.2 The QS quick start key setting”)
+/- Key ( / )
Use these keys to increase or reduce the speed of the motor.
As other function to adjust the value.
OLED Screen
Working mode option display: When the machine is on, press “S” key ,and to select the
working mode (Apex locator control endo motor—Apex locator only—Endo motor
only—Independent Endo motor and Independent apex locator) by “+/-”key as follows:(The
details to see “ 4.2.1 Four working mode”)
Apex locator control motor rotation
Apex locator and endo motor working
separately with no control

12
—
Motor working for the root canal preparation and apex locator working for the measurement
of the apical length at the same time, apex locator will control the rotation of motor.
—
Apex locator only, motor will not work
—
Motor only, apex locator will not work
—
Motor and apex locator will work at same time, but apex locator will not control motor
rotation
Apical length display
—The position of the file tip is shown by the canal length indicator
bar on the display. The Flash bar flashes ON and OFF once file is
inserted into root canal.
—APEX 00 displays reaching the apical,“--”and flashing means
beyond the apical. The meter’s 0.5 reading indicates that the tip of the
file is in or very near the apical.
(The numerals on the meter gauge do not represent millimeters.)
—If the file tip reaches the apical foramen, a single, sustained beep will sound, and the word
“APEX” and the little triangle next to the Flash Bar will start to flash ON and OFF.
Rotation mode
—
: Forward,
Rotation is in clockwise motion. When the load is beyond the set
torque limit or reach the apical, it will automatically reverse out, when the load is
removed, it will start normal rotation again.
—
: Reverse, Rotation is in anti-clockwise motion.
—
:
Optimum Torque Reverse, Rotation
is in
reciprocating
mode
.
Battery Symbol
The symbol is indicating the capacity of battery. The symbol will be animated when the battery
is being charged
:
The battery is full power or nearly full power
:
About 30-80 % remains
:
Less than about 30% remains
:
Battery are drained or the symbol flashing with alarm. Please charge the battery at once.
Notice:
The symbol indicating the remaining capacity of the battery. When load is applied to the file, the
symbol indicating the remaining capacity of the battery appears to become lower.

13
Alarm Symbol(The details to see “4.5.2
Alarm Sound Setting”
)
:
Max alarm
:
Medium alarm
: Lower alarm
: OFF
4. Operations
4.1 QS (Quick Start ON/OFF KEY function)
4.1.1
QS quick start key using
In order to make maximum imitation of dentists’ operation habits, we develop this Quick start function.
The doctor can set the most commonly used parameters to this function. Such as speed, rotation mode.
When the machine is off, press “” key to enter in quick start function:
1. Standby
in reciprocating mode I
2. Rotation
in reciprocating mode I
3. Standby
in reciprocating mode II
4.
Rotation in reciprocating mode II
4.1.2 QS quick start key setting
The default setting in the quick start mode:
Machine standby in Reciprocating mode I—Rotation in Reciprocating
mode I—Standby in Reciprocating mode II—Rotation in Reciprocating
Power off
First press
“ ”
, standby in
reciprocating mode I.
Forth press “ ”, rotation in
reciprocating mode II.
Press this
key for long
time
Second press “ ”, rotation in
reciprocating mode I.
Third press “ ”, standby in
reciprocating mode II.

14
mode II, in sequence.
Further options for quick start mode:
Machine standby in (Reciprocating/Clockwise Rotation/Anti-Clockwise Rotation) mode
I—Rotation in (Reciprocating/Clockwise Rotation/Anti-Clockwise Rotation) mode I, —standby in
(Reciprocating/Clockwise Rotation/Anti-Clockwise Rotation) mode II, —Rotation in in
(Reciprocating/Clockwise Rotation/Anti-Clockwise Rotation) mode II, in sequence.
Enter the setting:
When the motor is in quick start mode, long press “P” to enter in Quick Start mode setting, to
select OTR
(
reciprocating
)
—Forward (Clockwise Rotation)—Reverse ,adjust by
“+/-”
key
Adjustable Parameters:
Speed can adjust by
“+/-”
key
Torque are adjustable in Forward / Reverse mode
The Reciprocating direction and angle are adjustable in OTR mode
(Note: Details please refer to Guide for Quick start function.)
Exit setting:
Long press
“P”
key or short press on/off key to exit the setting.
4.2 Integrated Apex Locator
iRoot pro is equipped with an integrated apex locator.
WARNING:
Combined apical length measurement by using the contra angle and lip clip give only accurate
results when using the original contra angle by manufacturer supplied.
Use only endodontic NiTi files with a metal handle for this type of root canal measurement.
In some clinical cases accurate root canal measurement is impossible! ( for details see chapter
9 “Troubleshooting”)
Electric root canal measurement uses minimal auxiliary current. The values used in the device
are far below the values required in IEC 60601-1. Nevertheless, in rare cases electrical
sensation during the apical length measurement can occur. In this case, do not continue the
treatment with this patient.
4.2.1 Four working mode
There are four types of working mode related to Endo motor an Apex Locator.
Mode, Apex locator control motor how to rotate.

15
Mode, Apex locator is working independently, and endo motor is invalid.
Mode, Independent Endo motor, Apex locator is invalid.
Mode, Apex locator and motor work separately.
To short press “S” key to enter the working mode option, to select working mode in the select
box by “+/-”key, when the machine is on.
NOTICE:
In working mode, motor and apex locator will work at same time, but both work
independently without control to each other. When reach apical, the apex locator only indicate
the apical length, will not control motor to switch to anti-clockwise rotation and reverse out.
In working mode, motor and apex locator will work at same time, apex locator will control
the preparation of motor. Endo motor will auto start, auto reverse out
according to the root canal measurement of the apex locator.
4.2.2 Useful tips for accurate length determination
Gloves and rubber dam are recommended in order to isolate the tooth.
Dry the access cavity with the suction pump or a cotton-pellet.
Avoid any direct contact between the contra angle file and mucosa. Use the silicone sleeve for
the contra angle.
4.2.3 Optional Apical Line
This feature is convenient for users to make marks of the
relative distance from apical point;
The range of markers is from 15 to 27;
According to user labeled apical scale, when reaching marker
position, better visual and sound cues.
Complete following steps to change the marks of apical point
Long press “S” to enter other operation mode, keep short press “S” until it indicates apex
locator working length bar, to adjust by “+/-” key.
NOTICE:
Settings will be saved automatically
This mark for the apical is available in all working mode including QS mode and apex locator
control motor working mode once set.
Set the apical line from 15 to 27

16
Combined apical length
measurement
4.2.4 Operation of Apex Locator
We are committed to producing safe and reliable medical equipment to let doctors handier to use, so we
recommend doctors to use the apex locator control motor mode.
4.2.4.1 Connecting
For combined apical length measurement use the contra angle, covered by the silicone sleeve.
Connect the lip clip cable to the Micro USB port at bottom of the central unit. Insert the lip clip
into the connector at the end of the cable. Ensure the connection is solid.
Put the pip clip in the patient’s mouth (we recommend positioning it on the opposite side of the
tooth undergoing therapy).
For independent apex locator measurement use the separate file clamp with a manual measuring file
instead of the contra angle.
Connect the Measuring cable for apex locator to the Micro USB port at bottom of the central
unit. Insert the lip clip into one of the connectors, insert the file clamp into another connector.
And ensure both the connection is solid.
Put the lip clip in the patient’s mouth ( on the opposite side of the tooth undergoing therapy)
4.2.4.2
Measuring loop detection
A. For combined apical length measurement (Insert a Measuring cable
B,Contact with the lip clip and file,select the Apex locator
control motor rotation mode)
Contact the file installed on the Contra angle with the lip hook will cause
the following conditions:
1) File will anti-clockwise rotate
2) The warning will sound rapidly
3) Display on the screen:Root canal indicator scale full grid, the root canal indicator data: “- -”, APEX
non-stop flashing
At this time, it is proved that the measuring circuit is normal, and the next operation can be carried out
Independent apex locator measurement
Combined apical length measurement

17
Independent apex locator
measurement
B. For Independent apex locator(insert a
Measuring cable A and select the Independent endo motor mode)
Contact with the lip clip and file clamp will cause the following conditions:
1) The warning will sound rapidly
2) Display on the screen: Root canal indicator scale full grid, the root canal
indicator data: “- -”, APEX non-stop flashing
If the above-mentioned problems are not present, the reason for abnormal loop may be as follows:
One cable may be broken or in bad contact
The connecting of the cable is not good
The contact between lip hook and file climp or the lip hook and file is too short
The file is in poor conductivity
4.2.4.3 Application steps
Operation: After setting above parameters, connecting measuring cable, detecting measurement
loop, hand the lip hook on the patient’ s lip, the treatment can be started
The response of motor:
1)Putting the file into the root canal, the file will self-acting rotate as setting speed, torque. Or press
ON/OFF to drive the file to rotate
2)When the file approaching the apical foramen, the motor will automatically slow down, when
reaching the apical foramen, the motor will auto reverse.
Circuit detection normal display
interface
Abnormal operation interface of
loop detection
Circuit detection normal
display interface
Abnormal operation interface of
loop detection

18
Response of alarm:
With the file depth, alarm sound from slow to fast, to APEX, the alarm sound becomes constant, over
APEX the alarm sound rapidly changes
Screen display:
With the file depth, the root canal relative value will change to the apical/APEX appears, Root canal scale
is full, the root canal relative value is “00”; over apical, APEX flashing, Root canal scale is full, the root
canal relative value is “- -”.
4.3 Rotation and settings in different modes
4.3.1
Rotation in different modes
Forward: Rotation is in clockwise motion.
When the load is beyond the set torque limit or reach the apical, it will automatically reverse out,
when the load is removed, it will start normal rotation again.
Reverse: Rotation is in Anti-clockwise Motion.
I
n the general condition, when the Endo Motor Rotate in counter- clockwise motion will be claim as
reverse motion. The traditional rotary files are drawing from the canal by reverse motion. Therefore,
beep sound will occur when using this function.
Load lower than the set
torque limit value
Reverse rotation when load continues or
reach the apical, stop and return to clockwise
rotation when load is removed.
Load higher than the set
torque limit value,
anti-clockwise
Anti-Clockwise Rotation
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