Eighteeth Fast-Pack pro User manual

Fast-Pack pro
USER MANUAL

P/N: IFU-6335007
Version: 01
Issued: Nov 04, 2020
Size: 85mm×119mm

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Content
1. Scope of Fast-Pack pro ......................................................................................... 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................................................................................................................. 8
3.1 Intended Use..................................................................... 8
3.2 Contraindications.............................................................. 8
4. Installing the Fast-Pack pro................................................................................ 10
4.1 Installation of heating needle........................................ 10
4.2 Installation of adapter .................................................... 10
4.3 Connecting charge base ................................................11
5. Use Interface........................................................................................................... 12
6. Setting ...................................................................................................................... 13
6.1 Memory Parameter Setting........................................... 13
6.2 Advanced Setting ........................................................... 14
7. Operation................................................................................................................. 15
7.1 Charge ............................................................................. 15
7.2 Heating............................................................................. 16
8. Maintenance............................................................................................................ 17
8.1 Foreword.......................................................................... 17
8.2 General recommendations ........................................... 17
8.3 Autoclavable Components............................................ 18
8.4 Disinfection components .................................................. 22
9. Troubleshooting .................................................................................................... 23
10. Technical Data...................................................................................................... 24
11. EMC Tables ........................................................................................................... 25
12. Statement .............................................................................................................. 30

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

1 Scope of Fast-Pack pro
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1.2 Components and Accessories
Fast-Pack pro
Handpiece (1pcs)
Charge Base
(1pcs)
Adapter (1pcs)
Heating Needle S
(1pcs)
Size: 40/0.025
Color: Black
Heating Needle M
(1pcs)
Size: 50/0.05
Color: Yellow
Heating Needle L
(1pcs)
Size: 60/0.06
Color: Blue
1.3 Options (sold separately)
Handpiece Base

2 Symbols used in the User Manual
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2. Symbols used in the User Manual
WARNIN G
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
Lot of manufacture
Class II equipment
Type B applied part
CE marking
Direct current
WEEE directive marking
Keep dry
134 C
Can be autoclaved up to a maximum temperature
of 134° Celsius
Authorized Representative in the European

2 Symbols used in the User Manual
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Community
55 C
20 C
Temperature limitation
80%
20%
Humidity limitation
106kPa
70kPa
Atmospheric pressure limitation
Manufacturer’s LOGO
Consult instructions for use
Washer-disinfector for thermal disinfection

3 Before Use
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3. Before Use
3.1 Intended Use
Fast-Pack pro is intended for warming and softening gutta-percha master cones and
searing off gutta-percha cones.
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.
WARNIN G
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. 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 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 Fast-Pack pro, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result. Do not charge,
operate or store at high temperatures. Comply with the specified operating and
storage conditions.
4. Gloves and a rubber dam are compulsory during treatment.
5. If irregularities occur in the device during treatment, switch it off. Contact the
agency.
6. No modification of this device is allowed. Never open or repair the device yourself，

3 Before Use
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otherwise, void the warranty.
7. Do not use the device in the presence of free oxygen, flammable anesthetic gas
mixtures or flammable substances.
8. If there is any liquid leaked, it indicates that the battery is leaked. Remove all of
the leaked liquid and contact the local agency.
9. Do not use this device for any dental procedure other than root canal obturation.
10. Thermal hazard risk exists for patients. Cautions should be exercised at
temperature settings above 200℃.
11. The heating needle must be cleaned, disinfected and sterilized prior to and
following every treatment.
12. Please follow the sealer's instruction for use when sealers are used during the
operation.

4 Installing the Fast-Pack pro
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4. Installing the Fast-Pack pro
4.1
Installation of
heating needle
Make sure the hexagon plum
blossom groove on heating needle
is aligned with the hexagon plum
blossom boss 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.
WARNIN G
After the operation is completed, wait
for the heating needle to cool down and
remove it to prevent the heating needle
from being damaged accidentally. The
cooling process will take about 2-3
seconds and the real-time temperature
will show on the screen.
Even if the heating needle cools down
already, we strongly recommend not to
touch the metal part on heating needle,
there is a risk of heat injury or damaging
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.

4 Installing the Fast-Pack pro
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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.
NO TE
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.
NO TE
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

5 Use 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 for 2 seconds to enter memory parameter
setting. Parameter T1 to T5 can be set independently.
Heating
Long press
Turn Power Off
Long press for more than 2 seconds.
Advanced setting
During power off state, holding down press then
press to enter advanced setting. Press till
target setting, press to adjust, then press to
confirm.

6 Setting
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6.Setting
6.1 Memory Parameter Setting
90℃
T1
Fast-Pack pro has 5 memory programs, press
to change during standby state, the memory
number T1 will change accordingly.
Temperature
℃
90
During any memory, holding down press
then press for 2 seconds, the “Temperature”
of this memory can be changed.
Press till target temperature, the
temperature can be set to 90
℃
, 120
℃
, 140
℃
,
150
℃
, 160
℃
, 180
℃
, 200
℃
, 220
℃
, 250
℃
and
300
℃
.
Press to confirm.
Keep heat Time-
Sec
10
Press again, the “Keep-heat Time” of this
memory can be changed.
Press till target time, the time can be set to
3, 5, 8 and 10 seconds.
Press to confirm.
CoolingDisplay
Sec
3
Press again, the “CoolingDisplay” of this
memory can be changed.
Press till target time, the time can be set to
0, 3, 5 and 10 seconds.
Press to confirm.

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

7 Operation
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7.Operation
7.1 Charge
Display the present remaining amount of the battery.
When the battery icon appears and flashes on the
screen, it means the remaining battery power is less than
15%. Please charge the device in time.
NO TE
If the power is less than 15%, the device must be
recharged within 30 days, otherwise the battery will be
damaged.
Alter na ti ve ch arging m ethod
Charge without charge base is also available, connect
adapter to handpiece directly, the charge state will show
on the screen.
Charge with charge base is recommended (See chapter
4.3 Connecting charge base).
NO TE
Only the original adapter could be used.
Do not use the device while charging.
The handpiece power connector can only be used to
connect the original adapter cord for charging purpose.
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.

7 Operation
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7.2 Heating
Press to heat the heating needle.
The indicator LED lights up during heating.
WARNING
Do not place the heated heating needle in the root
canal for more than 4 seconds to prevent thermal
injury to the patient.
Only the end of the heating needle (about 4-5mm)
can be heated. Use this area to cut the gutta percha.
12 3
166℃
2
1
The “Keep-heat Time” will display on the screen.
When the set time is reached, the heating process will
stop.
2
Heating indication
3
Real time heating temperature
2
1
66℃
Release , the heating needle will cool down.
1
Cooling indication
2
Real time cooling temperature
When the set time of “CoolingDisplay” is reached, the
screen will switch to the standby interface.
Tip e rror
If the heating needle is not installed correctly, or the
heating needle is broken, the “Tip error” will appear.
Heating area

8 Maintenance
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8.Maintenance
8.1 Foreword
The part for clinical application contamination is the outer surface of the heating needle.
For hygiene and sanitary safety purpose, the component must be cleaned, disinfected
and sterilized before each usage to prevent any contamination. This concerns the first use
as well as the subsequent uses. Comply with your national guidelines, standards and
requirements for cleaning, disinfection and sterilization.
Reprocessing procedures have only limited implications to these dental instruments. The
limitation of the numbers of reprocessing procedures is therefore determined by the
function / wear of the device. From the processing side there is no maximum number of
allowable reprocessing. The device should no longer be reused in case of signs of
material degradation.
In case of damage, the device should be reprocessed before sending back to the
manufacturer for repair.
8.2 General recommendations
The user is responsible for the sterility of the product for the first cycle and each
further usage as well as for the usage of damaged or dirty instruments, where
applicable after sterility.
For your own safety, please wear personal protective equipment (gloves, safety
glasses, etc.).
Use only a disinfecting solution which is approved for its efficacy (VAH/DGHM-listing,
CE marking, and FDA approval) and in accordance with the DFU of the disinfecting
solution manufacturer.
The water quality has to be convenient to the local regulations especially for the last
rinsing step or with a washer-disinfector.
Thoroughly clean and wash the components before autoclaving.
Do not use bleach or chloride disinfectant materials.

8 Maintenance
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8.3 Autoclavable Components
Autoclavable Components
Heating needle
WARNING
Only the components above can be autoclaved.
Before first use and after each use, sterilize the above components.
Reprocessing Instructions
Preparation
at the Point
of Use:
Before cleaning, disconnect the heating needles from the
handpiece. Refer to Chapter 4.1 of this manual for disassembly
instructions. Remove gross contaminations from the components
with code water (<40°C) immediately after use. Don’t use a fixating
detergent or hot water (>40°C) as this can cause the fixation of
residuals which may influence the result of the reprocessing
process.
Store the instruments in a humid surrounding.
Do not submerge the components or wipe them with any of the
following functional water (acidic electrolyzed water, strong
alkaline solution, or ozone water), medical agents (glutaral, etc.),
or any other special types of water or commercial cleaning liquids.
Such liquids may result in metal corrosion and adhesion of the
residual medical agents to the components.
Transportat
ion:
Safe storage and transportation to the reprocessing area to avoid
any damage and contamination to the environment.
Preparation
for
Decontamin
ation:
The devices must be reprocessed in a disassembled state.
Observe suitable personal protective measures.
Pre-
Cleaning:
Do a manual pre-cleaning, until the components are visually clean.
Submerge the components in a cleaning solution and flush the
lumens with a water jet pistol with cold tap water for at least 10

8 Maintenance
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seconds. Clean the surfaces with a soft bristol brush.
Cleaning:
Regarding cleaning/disinfection, rinsing and drying, it is to
distinguish between manual and automated reprocessing
methods. Preference is to be given to automated reprocessing
methods, especially due to the better standardizing potential and
industrial safety.
Automated Cleaning:
Carefully put the components into the washer-disinfector on a tray
and set the parameters as follows, then start the program:
•4 min pre-washing with cold water (<40°C);
•emptying
•5 min washing with a mild alkaline cleaner at 55°C;
•emptying
•3 min neutralising with warm water (40°C);
•emptying
•5 min intermediate rinsing with warm water (40°C);
•Emptying
The automated cleaning processes have been validated by using
0.5% neodisher MediClean forte (Dr. Weigert).
Note Acc. to EN ISO 17664 no manual reprocessing methods are
required for these devices. If a manual reprocessing method has
to be used, please validate it prior to use.
Use only approved washer-disinfectors according to EN ISO
15883, maintain and calibrate it regularly.
Follow instructions and observe concentrations given by the
manufacturer (see general recommendations).
Disinfection
:
Automated Thermal Disinfection in washer/disinfector under
consideration of national requirements in regards to A0 value (see
EN ISO 15883).
A disinfection cycle of 5 min disinfection at 93°C has been
validated for the device to achieve an A0 value of 3000.
After cleaning, the instruments should be automated disinfected

8 Maintenance
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immediately. A manual disinfection is not recommended. Please
use fully demineralized water.
Drying: Automated Drying:
Drying the instruments according to drying cycle of
washer/disinfector. If needed, additional manual drying can be
performed through lint free towel. Insufflate cavities of instruments
by using sterile compressed air.
Functional
Testing,
Maintenanc
e:
Visual inspection for cleanliness of the instruments and
reassembling. Functional testing according to instructions of use.
If necessary, perform reprocessing process again until the
instrument is visibly clean.
Before packaging and autoclaving, make sure that the
components have been maintained according to the
manufacturer’s instruction.
Packaging:
Pack the instruments in an appropriate packaging material for
sterilization.
WARNING
Check the validity period of pouch given by the manufacturer
to determine the shelf life.
Use pouches which resist to a temperature up to 141℃and
in accordance with EN ISO 11607.
Sterilization
:Sterilization of instruments by applying a fractionated pre-vacuum
steam sterilization process (according to EN 285/EN 13060/EN
ISO 17665) under consideration of the respective country
requirements.
Minimum requirements: 5 min at 134 °C.
Maximum sterilization temperature: 137°C.
Drying time: at least 8min.
Flash sterilization is not allowed on lumen instruments!
WARNING
Use only approved autoclave devices according to EN 13060
or EN 285.
Use a validated sterilization procedure according to EN ISO
17665.