Eighteeth E-xtreme User manual

Endo Motor USER MANUAL
Changzhou Sifary Medical Technology Co., Ltd.
E-xtreme

Version: S02
IFU- 6035009/S02
Issued: Dec. 10 2020
Size：160mm X 92mm

Page 3/52
Content
1. Scope of E-xtreme..........................................................................................5
1.1Parts Identification...................................................................................... 5
1.2Components and Accessories.................................................................. 6
1.3 Options......................................................................................................... 6
2. Symbols used in the User Manual............................................................ 7
3. Before Use.........................................................................................................9
3.1Intended Use................................................................................................ 9
3.2Contraindications........................................................................................ 9
4. Installing the E-xtreme.............................................................................. 11
4.1Installation of the contra angle............................................................. 11
4.2Install the file..............................................................................................11
4.3Charging...................................................................................................... 12
4.4Install the Insulation Sleeve....................................................................13
5. Use Interface................................................................................................. 14
5.1Panel key..................................................................................................... 14
5.2Screen display............................................................................................ 15
5.3Terms and definition.................................................................................16
6. Setting............................................................................................................. 17
6.1Set memory mode.................................................................................... 17
6.2Set parameters...........................................................................................18
6.3Preset programs........................................................................................ 21
6.4Advanced setting...................................................................................... 23

Page 4/52
6.5Parameter logic..........................................................................................26
7. Operation........................................................................................................28
7.1 Charge....................................................................................................... 28
7.2Motor Operation....................................................................................... 30
8. Cleaning, Disinfection and Sterilization................................................... 32
8.1Foreword..................................................................................................... 32
8.2General recommendations..................................................................... 32
8.3Autoclavable Components..................................................................... 33
8.4Disinfection Components........................................................................... 38
9. Error warnings...............................................................................................39
10. Troubleshooting.........................................................................................40
11. Technical Data.............................................................................................42
12. EMC Tables...................................................................................................44
13. Statement.....................................................................................................51

1 Scope of E-xtreme
Page 5/52
1. Scope of E-xtreme
1.1 Parts Identification
1. Contra Angle
2. Motor Handpiece
3. Handpiece Base
4. Insulating Sleeve (optional)
5. Spray Nozzle
6. Adapter
Note: This product does not contain root canal file

1 Scope of E-xtreme
Page 6/52
1.2 Components and Accessories
Motor Handpiece
(1pcs)
Handpiece Base
(1pcs)
Contra Angle
(1pcs)
Adapter (1pcs)
Spray Nozzle (1pcs)
USER MANUAL
(1pcs)
Certificate (1pcs)
Warranty card (1pcs)
1.3 Options
Insulating Sleeve

2 Symbols used in the User Manual
Page 7/52
2. Symbols used in the User Manual
WARNING
If the instructions are not followed properly, operation
may lead to hazards for the product or the user/patient.
NOTE
Additional information, explanation of operation and
performance.
Serial number
Catalogue number
Manufacturer
Date of manufacture
LOT
Batch number
Safety class II device
Type B applied part
CE marking
Direct current
Dispose of in accordance with the WEEE directive
Keep dry
Sterilizable in a steam sterilizer (autoclave) at the
temperature specified
Authorized Representative in the European Community
-20℃
55℃
Temperature limitation
20%
8 0%
Relative humidity limitation

2 Symbols used in the User Manual
Page 8/52
1 06kPa
70kPa
Atmospheric pressure limitation
Manufacturer's LOGO
Consult instructions for use
!
Be careful! Refer to relevant documents
Washer-disinfector for thermal disinfection

3 Before Use
Page 9/52
3. Before Use
3.1 Intended Use
Use for dental root canal treatment using endodontic instruments
in torque controlled continuous rotation and in reciprocating
movement.
This device must only be used in hospital environments, clinics or
dental offices by qualified dental personnel and not used in the
oxygen-rich environment.
3.2 Contraindications
The E-xtreme is contraindicated in cases where patient/user carry
medical implants such as pace makers or cochlear implants etc.
Do not use the device for implants or other non-endodontic dental
procedures.
Safety and effectiveness have not been established in pregnant
women and children.
WARNING
Read the following warnings before use:
1. The device must not be placed in humid surroundings or anywhere
where it can come into contact with any type of liquids.
2. Do not expose the device to direct or indirect heat sources. The
device must be operated and stored in a safe environment.
3. Do not use the equipment in the presence of free oxygen,
anesthetic gas or combustible materials. The equipment must be
operated, used and stored in a safe environment.
4. The device requires special precautions with regard to electrom-
agnetic compatibility (EMC) and must be installed and operated in
strict compliance with the EMC information. In particular, do not use
the device in the vicinity of fluorescent lamps, radio transmitters,
remote controls and do not use this system near the active HF
Surgical Equipment in the hospital. Portable RF communications
equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to
any part of the E-xtreme, including cables specified by the manu-
facturer. Otherwise, degradation of the performance of this equipm-
ent could result.
5. Please do not charge, use or store this equipment at high temp-
erature. Please pay attention to the use and storage conditions.

3 Before Use
Page 10 /52
6. Gloves and a rubber dam are compulsory during treatment.
7. Never open or repair the device yourself，otherwise, void the wa-
rranty.
8. If irregularities occur in the device during treatment, switch it off.
Contact the agency.
9. Please use the original power adapter when charging; do not use
the equipment for treatment during charging.
10. If liquid flows out of the handpiece, it can be judged as battery
leakage. Please stop using immediately and contact the local dealer
for treatment.
11. Do not dismount the contra angle during the operation of the
main engine, otherwise the contra angle and motor gear will be
damaged.
12. Please use the original contra angle.
13. Use continuous file in continuous mode; use reciprocating file in
reciprocating mode, and use according to rotation speed, torque and
return angle recommended by the root canal file manufacturer.

4 Installing the E-xtreme
Page 11 /52
4. Installing the E-xtreme
4.1 Installation of the contra angle
Make sure 4 pins on contra angle
alignment the slots of handpiece,
plug them together until it “clic-
k” securely into place.
The contra angle can be 360 deg-
rees rotated without take off, make
it easy to watch the LCD in trea-
tment by rotating the contra angle.
WARNING
1. Make sure the assembly is connected properly, otherwise might
cause unexpected motor reverse, even hurt the patients
2.After connecting the contra angle and handpiece, pull it gently to
make sure the connection is good.
4.2 Install the file
Install Remove
Install: insert the root ca-
nal file and rotate it slig-
htly from left to right to
ensure that the file needle
is aligned with the inter-
nal bayonet, and then pu-
sh it in slightly to compl-
ete the installation.
Remove: press and hold
the back cover button on
the contral angle to rele-
ase the internal bayonet
and gently pull out the
root canal file.
PUSH
BUTTON

4 Installing the E-xtreme
Page 12 /52
WARNING
1. Inspect the file head before inserting the file. Do not use the
damaged file head.
2. Be careful when inserting and removing files to avoid injury to
fingers.
3. Pull the file gently to make sure that the file is secure in hand-
piece properly, otherwise it may pop out and hurt the patient.
4. When removing the file, press the button tightly to release the
internal bayonet. If the bayonet is not fully released, the bearing
will be damaged.
5. Make sure the motor is stopped when inserting and removing
files.
4.3 Charging
M 1 3.0 N cm
·
400 RPM
Show the remaining power.
This icon indicates that the
remaining power is less than
15%, please charge it in tim-
e.
Connect the power adapter
to E-xtreme as shown.
WARNING
Only the original adapter could be used.
When the power adapter
is connected to E-xtreme,
the screen will display the
figure on the left, which
indicates charging.

4 Installing the E-xtreme
Page 13 /52
4.4 Install the Insulation Sleeve
Install：assemble according
to the left figure
Remove：pull out the cover
in the opposite direction
NOTE
The insulating sleeve is ma-
inly used for secondary isol-
ation to avoid cross infec-
tion.

5 Use Interface
Page 14 /52
5. Use Interface
5.1 Panel key
①●Main swtich
②Display screen
③SSetting key
④+Increase key
⑤-Decrease key
Power on
Press ●more than 0.5 seconds to
turn on the instrument.
Memory Change
Press +or -to change at st-
andby mode.
Operation Mode Change
Press Sonce at standby mode,p-
ress +or -to switch, then p-
ress ●or wait 5 seconds to con-
firm.
Parameter Adjustment
Press Still target parameters are
displayed at standby mode, press +
or -to adjust, then press ●or
wait 5 seconds to confirm.
Preset Program Selection
Long press Sat standby mode to
enter preset program, press +or
-to select deserve program and
press ●to confirm.
Power off
Holding Sand press ●
Advanced Setting
Holding Sthen press ●to ent-
er advanced setting at power off mo-
de, press Still target parameters
are displayed, press +or -to
adjust the parameters, then press ●
to confirm.

5 Use Interface
Page 15 /52
5.2 Screen display
M 1 3.0 N cm
·
400 RPM
Standby interface
1 Residual battery power
2 Speed
3 Unit of speed (Revolutions
Per Minute)
4 Memory mode number
5 Torque
6 Unit of torque (Newton
Centimeter)
7 Operation mode
500rp m
Working mode interface
1 The set maximum torque
2 Real torque
3 Torque display scale
4 The preset speed

5 Use Interface
Page 16 /52
5.3 Terms and definition
Fwd/Fw
Forward ( Clockwise rotation )
Rev/Rv
Reverse ( Counter clockwise rotation )
REC
Reciprocation: Be applied to reciprocating file,
path file and rotary file protection by setting some
special angle
Memory
mode
Such as M0-M9
Operation
mode
Such as Fwd, Rev (set in M1-M9)，Reciprocation
(M0)
TRQ
Torque
MEM
Memory
R·D
Rotate Direction
DIR
Direction
Separation of
instruments
The file used in root canal therapy is broken
accidentally.

6 Setting
Page 17 /52
6. Setting
6.1 Set memory mode
M 1 3.0 N cm
·
400 rpm
M 1 3.0 N cm
·
400 RPM
The device has 10 memory mod-
es (M0-M9) ， press +or -
at standby mode ， memory
number (②) will change
accordingly.
Each memory mode includes its
own speed (①)，operation mode
(④) and torque (③). These para-
meters can be set separately.
(Adjust parameters according
to chapter 6.2).
M 0 180 ° 30°
M0 is a separate mode of recip-
rocating mode. Including forwa-
rd angle(①) and reverse angle
(④). These parameter can be set
separately. (Adjust parameters
according to chapter 6.2).
Figure(②)means Forward ， and
figure(⑤)means Reverse. The bi-
gger figure means angle of this
direction is bigger than the other
one.

6 Setting
Page 18 /52
6.2 Set parameters
WARNING
All parameters must be set according to the recommended values
of root canal file manufacturer. Before starting the device for
operation, make sure that all parameters are correct, otherwise
there is a risk of instrument separation.
M 1 3.0 N cm
·
400 rpm
M 1 3.0 N cm
·
400 RPM
Before starting the motor, check
whether the operation mode (①)
is correct. If it is not the expected
operation mode, press Sonce
on the standby mode to enter
the operation mode selection,
press +or -to switch, and
then press ●or wait for 5 se-
conds to confirm the operation
mode.
M 1
s
TRQ
SPEED: 400
+-
M 1 R D·
TORQUE: 3.0
+-
M 1 MEM
DIR: Fwd
-
s
s
RvF w -
s
M 1 3.0 N cm
·
400 rpm
M 1 3.0 N cm
·
400 RPM
M 1 3.0 N cm
·
400 rpm
M 1 3.0 N cm
·
400 RPM
The left figure describes the set-
ting of common functions of the
device (memory mode M1 to M9
are applicable). In standby mode
(①)press Sto enter the speed
setting, press +or -to set
the speed value; after the speed
value is set, press Sagain to
enter the torque setting, press
+or -to set the torque va-
lue. After the torque value is set,
press Sagain to enter the ro-
tation direction operation mode
(two modes: Fwd and Rev), press
+or -to set, then press ●
or Sor wait for 5 seconds to
confirm the operation mode.

6 Setting
Page 19 /52
NOTE
In different operation modes, the values of parameters will be
different according to the corresponding logic (Adjust
parameters according to chapter 7.2).
M 1 TRQ
SPEED: 400
+-
In M1-M9 memory mode, the s-
peed can be 120rpm-650rpm. Pr-
ess Sat standby mode till sp-
eed (①②) is displayed,press +
or -to set，then press ●or
wait for 5 seconds to confirm. T-
he left figure (③)means after pr-
essing Sagain will enter torq-
ue(TRQ) setting.
M 1 R D·
TORQUE: 3.0
+-
-
The torque value can be set from
0.5 to 4.0 N·cm. Press Sat st-
andby mode till torque (①②) is
displayed, press +or -to
set, then press ●or wait for 5
seconds to confirm. The left fig-
ure (③) means after pressing S
again will enter rotate direction
(R.D.) setting mode.

6 Setting
Page 20 /52
M 1 MEM
DIR: Fwd
RvF w -
Fwd or Rev can be set in opera-
tion mode of M1-M9. Press S
till the operation mode (①②④)
is displayed, press +or -
to set, then press ●or wait 5
seconds to confirm. The left
figure(③) means press Sag-
ain will enter memory mode
(MEM).
NOTE
When Rev operation mode is se-
lected, a continuous alarm sound
will appear after the device is
started to remind the operator
that the motor is in reverse
rotation.
M 0 30 ° 150°
s
s
s
M 0 210 ° 30°
M 0 150 ° 30°
M 0 180 ° 30°
s
M 0 250° 30°
M 0 30° 150°
s
The left figure describes the set-
ting of M0(REC mode):Press S
at M0(①)to switch different reci-
procating preset programs. Th-
ere are altogether 5 sets of pre-
set reciprocating programs.