Eighteeth Fast-Pack User manual

Fast-Pack
USER MANUAL

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Content
1. Scope of Fast-Pack...........................................................................................................................4
1.1 Parts Identification............................................................................................................4
1.2 Components and Accessories........................................................................................5
1.3 Options (sold separately)................................................................................................5
2. Symbols used in the User Manual.................................................................................................6
3. Before Use...........................................................................................................................................7
3.1 Intended Use.....................................................................................................................7
3.2 Contraindications..............................................................................................................7
4. Installing the Fast-Pack....................................................................................................................8
4.1 Installation of heating needle..........................................................................................8
4.2 Installation of adapter.......................................................................................................8
4.3 Connecting charge base .................................................................................................9
5. Use Interface.....................................................................................................................................10
6. Setting.................................................................................................................................................11
6.1 Memory Parameter Setting...........................................................................................11
6.2 Advanced Setting...........................................................................................................12
7. Operation...........................................................................................................................................13
7.1 Charge..............................................................................................................................13
7.2 Heating.............................................................................................................................14
8. Maintenance......................................................................................................................................16
9. Troubleshooting...............................................................................................................................18
10. Technical Data................................................................................................................................19
11. EMC Tables......................................................................................................................................20
12. Statement.........................................................................................................................................24

1Scope of Fast-Pack
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1. Scope of Fast-Pack
1.1 Parts Identification
1
2
3
4
1.Charge Base
2.Handpiece
3.Heating Needle(3PCS)
4.Adapter

1Scope of Fast-Pack
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1.2 Components and Accessories
Fast-Pack Handpiece (1pcs)
Part No. 6351001
Charge Base (1pcs)
Part No. 6351003
Adapter (1pcs)
Part No. 6316001+6316005
Heating needle S (1pcs)
Size: 40/0.025
Color: Black
Part No. 6351006
Heating needle M (1pcs)
Size: 50/0.05
Color: Yellow
Part No. 6351007
Heating needle L (1pcs)
Size: 60/0.06
Color: Blue
Part No. 6351008
1.3 Options (sold separately)
Handpiece Base
Part No. 6005002

2Symbols used in the User Manual
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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
Safety class II device
Type B applied part
CE marking
Direct current
Do not dispose of with normal household waste
Store in a dry place
134 C
Can be autoclaved up to a maximum temperature of 134°
Celsius
Authorized Representative in the European Community
55 C
20C
Temperature limitation
80%
20%
Relative humidity
106kPa
70kPa
Atmospheric pressure
Manufacturer’s LOGO

3Before Use
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3. Before Use
3.1 Intended Use
Fast-Pack is intended for heating and cutting Gutta-percha outside the mouth
during root canal treatment.
This device must only be used in hospital environments, clinics or dental
offices by qualified dental personnel.
3.2 Contraindications
This device must not be used in cases where a patient has been fitted with an
implanted heart pacemaker (or other electrical equipment) and has been cautioned
against the use of small electrical appliances (such as electric shavers, hair dryers,
etc.)
Safety and effectiveness have not been established in pregnant women and
children.
WARNING
Read the following warnings before use:
1. Do not use this device for any dental procedure other than root canal obturation.
2. Do not use the device in the presence of free oxygen, flammable anesthetic gas
mixtures or flammable substances.
3. The device must not be placed in humid surroundings or anywhere where it can
come into contact with any type of liquids.
4. Thermal hazard risk exists for patients.
5. Do not expose the device to direct or indirect heat sources. The device must be
operated and stored in a safe environment.
6. The device requires special precautions with regard to electromagnetic
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, portable or mobile RF
communication devices and do not charge, operate or store at high
temperatures. Comply with the specified operating and storage conditions.
7. Gloves and a rubber dam are compulsory during treatment.
8. If irregularities occur in the device during treatment, switch it off. Contact the
agency.
9. Never open or repair the device yourself，otherwise, void the warranty.

4Installing the Fast-Pack
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4. Installing the Fast-Pack
4.1 Installation of heating
needle
Make sure one of the dents on heating
needle aligning the small triangle on
handpiece, push till to position.
Holding the grey shell to pull the heating
needle out from the handpiece.
The heating needle can be installed in
any one of 6 orientations. Pull it out
from handpiece then can be installed in
other orientations.
WARNING
➢To remove the heating needle, wait
for it to cool down, it takes about 2-3
seconds, and real-time temperature
will show on the screen.
➢Even the heating needle cool down
already, we strongly recommend not
touch the metal part on heating
needle, there is a risk of heat injure or
damage the heating needle, hold the
grey shell to remove.
4.2 Installation of adapter
Plug the head into the base if they are
separated in the package.

4Installing the Fast-Pack
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4.3 Connecting charge
base
Plug the USB of adapter into the charge
base, and plug the other end into a
power outlet.
The Power LED on charge base will
light up.
NOTE
Only the original adapter could be
used.
Put the handpiece all the way into the
charge base, the charge state will show
on the screen.
NOTE
Put the handpiece into the charge base
in the right direction, otherwise the
handpiece will not be charged.
If only need a base to put the device on
dentist element of dental chair (without
charge function), handpiece base is
recommended to use instead of charge
base.
Power LED

5Use Interface
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5.Use Interface
1
2
3
①Main switch
②Display Screen
③Power switch
Turn Power On
Long press
Change Memory
Shot press to change temperature memory
from T1 to T5
Memory Parameter Setting
During standby state, holding down press
then press in 2 seconds to entry memory
parameter setting, parameter of T1 to T5 can be
set independently
Heating
Long press
Turn Power Off
Long press more than 2 seconds
Advanced setting
During power off state, holding down press
then press to entry advanced setting, Press
till target setting, press to adjust, then
press to confirm

6Setting
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6.Setting
6.1 Memory Parameter Setting
90℃
T1
Fast-Pack has 5 memory programs, press to
change during standby state, the memory number
T1 will change according.
Tempera t u re
℃
90
During any Memory, holding down press then
press in 2 seconds, the “Temperature”of this
memory can be change.
Press till target temperature, the temperature
can be set from 90℃to 250℃.
press to confirm.
Keep heat Time-
Sec
10
Press again, the “Keep-heat Time” of this
memory can be change.
Press till target time, the time can be set 3, 5, 8
and 10 seconds.
press to confirm.
CoolingDisplay
Sec
3
Press again, the “CoolingDisplay” of this
memory can be change.
Press till target time, the time can be set 0, 3, 5
and 10 seconds.
press to confirm.

6Setting
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6.2 Advanced Setting
AutoPow e r Off
Min
5
During power off state, holding down press
then press to entry advanced setting, the
“AutoPowerOff” will appear on the display screen.
Press to adjust, the auto power off time can be
set 5, 10 and 15 minutes
press to confirm.
Beep Volume
Vol 1
Press again, the “Beep Volume” can be
change, press to adjust, the “Beep Volume” can
be set 0, 1 and 2.
press to confirm.
RestoreSettings
NO YES
Press again, the “RestoreSettings” can be
change, press to adjust, press to confirm.
NOTE
If choice “YES”, all the setting parameters will be
covered by factory settings.
Sa ve
NO YES
Press again, confirm the setting need to save
or not, press to adjust, press to save and
power off.

7Operation
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7.Operation
7.1 Charge
Displays the present remaining amount of the
battery.
Less than 15% remains, please charge.
NOTE
If the power if less than 15%, must be recharged
within 30 days, otherwise the battery will be
damaged.
Alternative charging method
Charge without charge base also available, using
adapter connect to handpiece directly, the charge
state will show on the screen.
Charge with charge base is recommended (See
chapter 4.3 Connecting charge base 错误!未找到
引用源。).
NOTE
Only the original adapter could be used.
Charging indication appears on the screen, and
flashes slowly, when battery is fully charged or in a
state near full charge, the flash will stop. Fully
charged will take about 4 hours, depending on
residual battery power and battery state.
It can be recharged 300-500 times, depending on
the operating conditions of the device.
WARNING
Do not change the battery, only trained technician
or distributor can change the battery, the electronic
parts will be damaged if use a wrong battery or
install with a wrong way.

7Operation
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7.2 Heating
Press and hold the raised ridge on the ring
switch to heat the heating needle.
The indicator LED lights up during heating.
Only the end of heating needle (about
4-5mm) will be heated, use this area to cut
the gutta percha.
12 3
166℃
2
1
The “Keep-heat Time” will display on
screen, When the set time is reached,
heating process will switch off.
2
Heating indication
3
Real time heating temperature
Heating area

7Operation
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2
1
66℃
Release your finger from the ring switch,
the heating needle will be cooling.
1
the cooling indication will appear.
2
Real time temperature of cooling
heating needle will appear.
When the set time of “CoolingDisplay” is
reached, will change to standby interface.
Tip e rror
If the heating needle isn’t installed
properly, or the heating needle broken, the
“Tip error” will appear.

8Maintenance
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8.Maintenance
Autoclavable Components
Heating needle
Autoclavable Procedure
Cleaning Disinfection
Packing
Sterilization
Storage
Cleaning: Clean the components with running water with a soft cloth.
Disinfection: Wipe the components with a piece of gauze that has been
dampened with Ethanol for Disinfection (Ethanol 70 to 80 vol%) and wrung out
thoroughly.
Packing: Pack the components in“Sterilization pouches”.
Sterilization: Steam sterilization at 134°C at least 4 minutes or
Steam sterilization at 121°C at least 35 minutes.
Minimum drying time after sterilization: 10 minutes.
Storage: Keep the components in sterilization packaging in a dry and clean
environment.
WARNING
Comply with your national guidelines, standards and requirements for cleaning,
disinfection and sterilization.
Be careful to avoid cross contamination when performing maintenance.
Must be autoclaved after use for each.
Only heating needle can be autoclavable.
NOTE
Heating needle head is easy to damage by external force, take care during
maintenance.

8Maintenance
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Disinfection components
Motor Handpiece
Charge Base
Adapter
Handpiece Base
Wipe the components with a piece of gauze that has been dampened with Ethanol for
Disinfection (Ethanol 70 to 80 vol%) and wrung out thoroughly.
NOTE
Do not use anything except Ethanol for Disinfection (Ethanol 70 to 80 vol%).
Do not use too much ethanol as it’s going into machine and damage the
components inside.

9Troubleshooting
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9.Troubleshooting
When trouble is found, check the following points before contacting your distributor.
If none of these are applicable or the trouble is not remedied even after action has
been taken, the product may have failed. Contact your distributor.
Problem
Cause
Solution
Ref.
chap
The power is not
turned on.
The battery is flat.
Charge the battery.
7.1
Press the power switch too
short time.
Long press the power
switch.
5
The power LED
on charge base
does not light.
Using a wrong adapter.
Use the original
adapter.
4.3
The adapter is not
connected.
Check the connection.
4.3
The plug of the adapter is not
inserted into the outlet.
Check the connection.
/
There is no electricity in the
outlet.
Check the connection.
/
No charge
indicator flash
on handpiece
screen
Put the handpiece into the
charge base in the wrong
direction.
Check the direction.
4.3
Charge pin of charge base
unable to rebound.
Remove debris which
between move part and
base of the charge pin.
/
Contactors are dirty.
Cleaning the surface of
contactors.
/
The charge base broken.
Using adapter connect
to handpiece directly,
and Contact your
distributor.
/
Handpiece
screen does not
appear
The handpiece broken.
Check if there is a sound
of beep or motor, and
Contact your
distributor.
/
No sound.
Beep volume set to 0.
Set beep volume to 1, 2
or 3.
6.2

10 Technical Data
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10.Technical Data
Manufacturer
Changzhou Sifary Medical Technology Co.,Ltd
Model
Fast-Pack
Dimensions
21.5cm x 17.5cm x 9cm±1cm (Outer box)
Weight
1kg±10%
Power supply
Lithium ion battery: 3.63V, 2600mAh, ±10%
Charger power supply
AC 100-240 V, ±10%
Charger power output
6V 3A
Frequency
50/60Hz, ±10%
Temperature
90℃~250℃
Electrical safety class
Class II
Applied part
B
Operating conditions
Use: in enclosed spaces
Ambient temperature: 5°C / 40 °C
Relative humidity: <80%
Operating altitude < 2000m above sea level
Transport and storage
conditions
Ambient temperature: -20 °C / +55 °C
Relative humidity: 20% - 80 %
Atmospheric pressure: 70kPa-106kPa

11 EMC Tables
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11.EMC Tables
Guidance and manufacturer’s declaration – electromagnetic emissions
The Fast-Pack is intended for use in the electromagnetic environment specified below.
The customer or the user of the Fast-Pack should assure that it is used in such an
environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions CISPR
11
Group 1
The Fast-Pack uses 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 equipment.
RF emissions CISPR
11
Class B
The Fast-Pack is suitable for use in all
establishments, including domestic
establishments and those directly connected to
the public low-voltage power supply network
that supplies buildings used for domestic
purposes.
Harmonic emissions
IEC61000-3-2
Not
applicable
Voltage
fluctuations/flicker
emissions
IEC 61000-3-3
Not
applicable
Guidance and manufacturer’s declaration – electromagnetic immunity
The Fast-Pack is intended for use in the electromagnetic environment specified below.
The customer or the user of the Fast-Pack should assure that it is used in such an
environment.
Immunity test
IEC 60601 test
level
Compliance level
Electromagnetic
environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
+6 kV contact
+8 kV air
+2, 4, 6 kV
contact
+2, 4, 8 kV air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be at
least 30 %.