Eighteeth Ultra X User manual

0197
Ultra X Ultrasonic Activator
USER MANUAL
Changzhou Sifary Medical Technology Co.,Ltd.

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Content
Scope of Ultra X.................................................................................................................................3
Parts Identification............................................................................................................3
Components and Accessories........................................................................................4
Symbols Used.....................................................................................................................................5
Before Use...........................................................................................................................................6
Scope of application.........................................................................................................6
Contraindications..............................................................................................................6
Setting up the Ultra X........................................................................................................................8
Installing the sleeve..........................................................................................................8
Installing the tip.................................................................................................................8
Tip Removal ......................................................................................................................8
Connecting the adapter...................................................................................................9
Use Interface.....................................................................................................................................10
Panel key.........................................................................................................................10
Operation...........................................................................................................................................11
Charge..............................................................................................................................11
Operation.........................................................................................................................13
Cleaning, Disinfection and Sterilization ....................................................................................15
Foreword..........................................................................................................................15
General recommendations............................................................................................15
Autoclavable Components............................................................................................15
Disinfection components...................................................................................................19
Error Warning ...................................................................................................................................20
Troubleshooting...............................................................................................................................21
Technical Data................................................................................................................................22
EMC Tables......................................................................................................................................23
Statement.........................................................................................................................................27

1 Scope of Ultra X
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Scope of Ultra X
Parts Identification
2
5
1
34
6
Accessories list
1. Tips(6pcs)
2. Wrench
3. Insulating sleeve
4. Ultra X handpiece
5. Adapter
6. Handpiece Base

1 Scope of Ultra X
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Components and Accessories
Ultra X handpiece (1pcs)
ORDER CODE: 6251001
Tip: S21(1 pcs)
ORDER CODE: 6251041
Tip: G18 (1 pcs)
ORDER CODE: 6251042
Tip: B18 (1 pcs)
ORDER CODE: 6251043
Insulating sleeve (1 pcs)
ORDER CODE: 6204002
Adapter (1 pcs)
ORDER CODE: 6016001
Wrench (1 pcs)
ORDER CODE: 6251007
Handpiece base(1pcs)
ORDER CODE: 6005002
User manual (1 pcs)
ORDER CODE: 6235001

2 Symbols Used
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Symbols Used
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
Class II equipment
Type B applied part
0197
CE marking
Direct current
WEEE directive marking
Keep dry
Consult instructions for use
134 C
Can be autoclaved up to a maximum temperature of 134°Celsius
Authorized Representative in the European Community
55C
20C
Temperature limitation
20%
8 0%
Humidity limitation
kPa
70
106
Atmospheric pressure limitation
Washer-disinfector for thermal disinfection
Manufacturer Logo

3 Before Use
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Before Use
Scope of application
Ultra X is used in endodontic treatment by application of ultrasonic energy. The
Ultra X can provide the energy for tip oscillation and vibration in frequency
(45KHz+5KHz) required to create sufficient acoustical streaming and cavitation
necessary to effectively clean, penetrate, and remove vapor lock. A cleaned root
canal system makes for better outcomes and reduces retreatment rate.
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.
Contraindications
The Ultra X 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. 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 E-connect S, including

3 Before Use
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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. Never open or repair the device by yourself, otherwise, void the warranty.

4 Setting up the Ultra X
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Setting up the Ultra X
Installing the sleeve
Always use a silicone sleeve.
Installing the tip
Make sure the thread on the tip is
aligning to the stud of the handpiece.
Plug them together and turn it carefully
NOTE
Only the original tip can be used.
The Activator tips are not sterile
when deliver and must be
autoclaved before being used for
the first time
Clean and disinfect the Activator
tips before every use
Tighten the tip clockwise with provided
wrench until the tip secure.
When you set the tip on the device, the
tip can be set within a range of 10°,
therefore, do not tighten the tip in
excess.
Warning
Inspect the tip before inserting. Do
not use the damaged tip.
Make sure the device is stopped
when inserting and removing tips.
Pull the tip gently to make sure that
the tip is secure in handpiece
properly, otherwise it may pop out
and hurt the patient.
Tip Removal
Loosen the tip counterclockwise with
provided wrench until the tip shedding.
Warning
Estimated case number of uses per
tip: 20, taking 2 root canals per case
as a reference.
Be careful when inserting and removing
tips to avoid injury to fingers.

4 Setting up the Ultra X
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Connecting the
adapter
Connect the USB cable to the
handpiece power connector, and
plug the other end into a power
outlet. The Power LED on the
handpiece will flash (yellow).
NOTE
Only the original adapter can be
used.
Do not use the device while
charging.
Handpiece base is recommended to be
used to place the Ultra X to protect the tip
when the device is not in use.
Power LED

5 Use Interface
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Use Interface
Panel key
1
2
3
①Main switch
②Mode LED
③Power LED
Turn Power On
Press to turn on the device.
Output Power Adjustment
Long press can switch to “High Output
Power Mode” or “Low Output Power Mode”
during working.
HIGH OUTPUT POWER MODE
LOW OUTPUT POWER MODE
Turn Power Off
Press to turn off the output during
working. The Ultra X will turn off the output
and enters the standby state. The Ultra X will
shut down after 1 minute of standby
automatically.

6 Operation
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Operation
Charge
Power LED light up in “GREEN”
Battery power is >50%.
Power LED light up in “YELLOW”
Battery power is 15%~50%.
Power LED light up in “RED”
Battery power is <15%.
NOTE
If the power is less than 15%, the device
must be recharged within 30 days, otherwise
the battery will be damaged.
Power LED flashes in “RED”
Battery power is <5%. The device will stop
working and have voice prompt, please
charge immediately.
NOTE
The remaining amount of battery mark
indicates a voltage. When a load is applied
to the handpiece, the remaining amount of
battery mark appears to become lower

6 Operation
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Connect the adapter to the handpiece.
NOTE
Only the original adapter can be used.
3
Charging indication appears on the power
LED, and flashes in “YELLOW”(③), when
the battery is fully charged or in a state near
full charge, the flash will stop and light up in
“GREEN” (③).
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.
NOTE
When changing, other function will forcibly
stop and get in to the charging mode.
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.

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Operation
Turn on the device：Press on main switch
to turn on the device. Power LED will light
up.
Turn on the device: press on main switch
to turn power on. Power LED and Mode
LED will light up.
NOTE
●Once the device is started, it will
vibrate at the ultrasonic frequency. Do
not touch the tip at this time.
●Do not let the device vibrate for a long
time without load.
●Ensure that there is sufficient rinsing
fluid for cooling during use. Do not
operate without flushing fluid.
●Ensure that the tip is upper 2mm from
working length when moving the tip up
and down
●Activate intracanal solution for 30-60
seconds for optimal canal cleanliness
Long press on main switch for more than
1s during working, you can switch the
output power in cycle.
Turn off the device: Press on main switch
to turn off the device. The Ultra X will turn
off the output and enters the standby
state. The Ultra X will shut down after 1
minute of standby automatically.

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The Ultra X will automatically shut down after 3 minutes of continuous operation;
In addition, the machine has a timed reminder function, and there is a beep every
5s during the work.
Warning
Use the Ultra X outside the oral cavity to make sure that the device is
functioning properly.
Replace the tip on time to avoid file separation within the canal. Tips may
separate because of metal fatigue.
Heavy force / hand pressure on handpiece while using may even cause tip
separation.
NOTE
If there is any abnormal functioning, stop using the device and report to the
company.
This device is not suitable for all types of root canals. Do not use this device
on extremely deformed root canal.
Gloves and a rubber dam are compulsory during treatment.
Do not forget to remove the tip from the device after its use.

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Cleaning, Disinfection and Sterilization
Foreword
For hygiene and sanitary safety purpose, the components (Tips, Wrench, and
Insulating sleeve) 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.
General recommendations
7.2.1 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.
7.2.2 For your own safety, please wear personal protective equipment (gloves,
safety glasses, etc.).
7.2.3 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.
7.2.4 The water quality has to be convenient to the local regulations especially for
the last rinsing step or with a washer-disinfector.
7.2.5 Thoroughly clean and wash the components before autoclaving.
7.2.6 Do not clean the tips and wrench with an ultrasonic cleaning device.
7.2.7 Do not use bleach or chloride disinfectant materials.
Autoclavable Components
Autoclavable Components
Tip
Wrench
Insulating sleeve
WARNING
Only the components above can be autoclaved.
Before first use and after each use, sterilize the above components.
STEP NO.
INSTRUCTIONS
1
Initial treatment
Immediately after using, wipe gross

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at point of use
contaminations from the components, and
put them in container for transportation.
Prepare the components directly after
treatment.
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 orcommercial cleaning liquids.
Such liquids may result in metal corrosion
and adhesion of the residual medical agents
to the components.
2
Preparation
before cleaning
Remove and disconnect the components
(Tips, Wrench, and Insulating sleeve) before
cleaning. Refer to "Chapter 4- Setting up the
Ultra X" of this manual for disassembly
instructions.
Observe suitable personal protective
measures.
The following Step 2 to Step 4 are operated in a washer-disinfector:
WARNING
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).
Sufficient rinsing step should be available in purified water (max 10
germs/ml and max 0.25 endotoxin units/ml)
Avoid any contact between the tips and any instrument, kit, support or
container.
Make sure the components are dry before moving to the #5 step.
3
Cleaning:
Automated
Carefully put the components (Tips, Wrench,
and Insulating sleeve) into the washer-
disinfector and set the parameters as follows:
- Pre-cleaning: water temperature <30℃, 2

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min;
- Cleaning: water temperature 45℃, 5 min;
use an enzyme detergent solution (mild
and aldehyde free solution) which is
suitable to be used with washer-
disinfector, and use in accordance with
the IFU of the detergent solution
manufacturer;
- Rinsing: water temperature 45℃, 1 min
(rinsing twice).
4
Disinfection:
Thermal
Thermal disinfection at least 5 min at 90℃
/194°F, make sure A0 value≥3000.
5
Drying
Heat: 20min, 90℃/194°F
6
Maintenance
and Inspection
Inspect components and sort out those with
defects. Dirty components must be cleaned
and disinfected again.
7
Packaging
Pack each component in a separate steam-
sterilization pouch.
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℃(286°F) and in
accordance with EN ISO 11607.

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8
Sterilization
Steam sterilization at 134 ℃at least 6
minutes.
Minimum drying time after sterilization: 10
minutes.
WARNING
Use only approved autoclave devices
according to EN 13060 or EN 285.
Use a validated sterilization procedure
according to ISO 17665.
Respect the maintenance procedure of
the autoclave device given by the
manufacturer.
Use only this recommended sterilization
procedure.
Control the efficiency (packaging
integrity, no humidity, color change of
sterilization indicators, physicochemical
integrators, digital records of cycles
parameters).
The sterilization procedure must comply
with ISO 17665.
Waiting for cooling before touching.
9
Storage
Keep the components in sterilization
packaging in a dry and clean environment.
WARNING
Sterility cannot be guaranteed if
packaging is open, damaged or wet.
Check the packaging before using it
(packaging integrity, no humidity and
validity period).

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The instructions provided above have been validated by the manufacturer of
the medical device as being capable of preparing a medical device for use.
It remains the responsibility of the processor to ensure that the processing,
as actually performed using equipment, materials and personnel in the
processing facility, achieves the desired result. This requires verification
and/or validation and routine monitoring of the process. Likewise, any
deviation by the processor from the instructions provided should be properly
evaluated for effectiveness and potential adverse consequences.
Disinfection components
Handpiece
Handpiece Base
Adapter
Wipe all the surfaces with a cloth lightly moistened with Ethanol for Disinfection
(Ethanol 70 to 80vol%) at least 2min, repeat for 5 times.
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.

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Error Warning
The device stops working
and beeping with Power LED
flashes in red.
The power is very low. Charge it immediately
Power LED lights up in
“BLUE”
The main board is broken. Please stop using the
device immediately and remove the battery.
Contact your local distributor.