Side-Effects - septodont Biodentine Mixer Manual De Instrucciones

3. Mixing
3.1. Transfer the cartridge from the activation socket to the Mixing arm (see picture G step 1)
3.2. lock the cartridge manually by making a clockwise quarter turn. (See picture G step 2)
3.3. Close the lid (see picture H step 1)
3.4. Press the Start button (see picture H step 2)
Warning; The START button is magnetically engaged, do not wear any magnet.
3.5. The START button will progressively become green indicating the mixing time elapsed
(time of the mix : 30secondes)
3.6. At the end of the mix, the START button will blink green and will beep twice.
3.7. Open the lid. (see picture I step 1)
3.8. Unlock the cartridge from the mixing arm making a counterclockwise quarter turn and
remove it. (see picture I step 2 and 3)
3.9. Close the lid
3.10. Use the cartridge following the Biodentine XP instructions for use.
3.11. Turn off the mixer when further operation is no longer needed.
WARNINGS
1. This device is designed to activate and mix Biodentine
cartridges manufactured by Septodont.
2. Manipulate the device with appropriate personal protective equipment
3. Remove the foam around the mixing arm before first use
4. Always put Biodentine™ Mixer on a flat surface.
5. Please follow the instruction for use
6. For more information about the Biodentine
read the Biodentine
7. The lid must be closed before pressing the START button to allow the mixer to start running.
8. The mixing process starts by simply pushing the START button.
9. Speed level is electronically controlled and regulated to ensure a consistent speed.

SIDE-EFFECTS

No known side effects.
Please report any serious incident that occurred in relation to the device to Septodont
(vigilance@septodont.com) and to the local competent authority for medical devices.
TROUBLESHOOTING
Scenario
The device fails
to function after
pressing START
button
The device moves
while mixing
The cartridge cannot
be insert in the
Mixing arm
The cartridge is
ejected during the
mixing
The mix stops
The START button
blinks red with
beeping sound
(Failure mode)
The device has been tested to meet the following standards: IEC60601-1-2: 2014, EN60601-
1-2: 2014, (EU) MDR 2017/745
WARRANTY
SEPTODONT warrants that the product will be free from substantial defects in material and
workmanship, and will substantially perform in accordance with the technical specifications set
XP cartridge instructions for use.
TM
Cause
Main switch has not
been turned on
Power cord has come
loose
Lid has not been shut
The device is not
placed on flat surface
The cartridge is not
correctly activated
The Mixer lever was
not pulled down until
the clicking sound
The cartridge is not
correctly locked onto
the Mixing arm
The lid is opened
during the mixing
The lid is opened for
more than 10 seconds
XP 200 / Biodentine
TM
XP 200 / Biodentine
TM
Turn on the main switch
Fully plug in the power cord
Make sure the lid is shut before mixing
Make sure the device is placed on flat
surface
Place the cartridge on the activation
socket and pull down the mixer lever
until you hear the clicking sound
Open the lid, discard the cartridge.
Close the lid and press "START"
Discard the cartridge.
5
TM
XP 500, please
TM
Solution
XP 500