Woodpecker PT-A User manual

Contents
Forward............................................................................................................................1
1 Introduction...................................................................................................................1
2 Installation.....................................................................................................................4
3 Function and operation .................................................................................................7
4 Troubleshooting ..........................................................................................................12
5 Cleaning, disinfection, and sterilization......................................................................15
6 Maintenance, storage, and transport ...........................................................................20
7 Environmental protection............................................................................................21
8 After service ................................................................................................................21
9 Manufacturer’s right ..................................................................................................21
10 Symbol instruction ...................................................................................................22
11 European authorized representative ..........................................................................23
12 EMC-Declaration of conformity...............................................................................23
13 Statement...................................................................................................................27

1
Forward
Guilin Woodpecker Medical Instrument Co., Ltd is a professional manufacturer re-
searching, developing, and producing dental products. Woodpecker owns a sound qua-
lity control system and two brands, Woodpecker and DTE. Its main products include
Ultrasonic air polishing Periodontal Treatment Device, Ultrasonic Scaler, Curing light,
Apex locator, Ultrasurgery, automatic water supply system, etc.
1 Introduction
1.1 Brief introduction
PT-A Dental Scaler and Air Polisher has both ultrasound system and air polishing
system. It is suitable for periodontal treatment and root canal irrigation in dental clini-
cal treatment. It can remove subgingival and supragingival calculus and plaque, so as
to achieve the therapeutic eect of consolidating periodontal tissue. The features of this
device are:
1) According to the selected handpiece, automatically switch the working mode.
2) The front panel adopts touch LCD screen, and the function selection and working
status indication are simple and clear.
3) The rounded vibration trajectory of the tip realizes treatment and polishing at the
same time. With small amplitude of tip, achieve painless treatment.
4) Titanium alloy tip will not hurt cementum or enamel.
5) In the automatic water supply mode, special chemical solutions such as hydrogen
peroxide, sodium hypochlorite and chlorhexidine can be used to improve the clinical
treatment eect.
6) The automatic frequency tracking system is used to automatically search for the
best working condition, which brings more stable performance of device.
7) The three-piece design of air polishing handpiece is easy to load and unload for
cleaning and maintenance.
8) The powder tank adopts a side cone structure to eectively reduce the residual
amount of powder.
9) Detachable ultrasonic handpiece and air polishing handpiece can be sterilized un-
der high temperature of 134℃ and high pressure of 0.22MPa.
10) The working process is fully automatic controlled by microcomputer, which is
convenient and simple to operate and if of high eciency.
1.2 Model
PT-A
1.3 Device conguration
Please refer to the packing list for device congurations.
1.4 Structure and components
It consists of main unit, water bottle, powder tank, prophylaxis powder (Sodium

2
bicarbonate, hydrophobic silica, edible essence), air polishing handpiece, ultrasonic
handpiece, working tips, sand blasting nozzle, power adapter and foot petal, etc.
Appled part:working tips, sand blasting nozzle.
1.5 Scope of application
1.5.1 Ultrasound system
① Scaling
· Removal of supragingival calculus
· Removal of stains
② Endo
· Preparation, cleaning and irrigation of root canals
· Retrograde preparation of root canals
· Condensing gutta-percha
· Removal of crown, bridges and restorations
③ Restorative
· Cavity preparation
· Luting inlays and onlays
· Condensing of amalgams
④ Perio
· Scaling and root planing
· Periodontal treatments
1.5.2 Air polishing system
· Remove dental plaque
· Surface preparation before bonding/cementation of inlays, onlays, crowns and ve-
neers
· Perform the tooth surface preparation before placing the composite restoration.
· Cleaning before sticking orthodontic brackets
· Eectively remove plaque and tartar for orthodontic patients
· Cleaning the implant xture before loading
· Stain removal for shade determination
· Remove plaque before uoride treatment
· Remove plaque and tartar before whitening procedure
1.6 Contraindications
1.6.1 The hemophilia patient is forbidden to use this equipment.
1.6.2 The patients with heart pacemaker are forbidden to use this equipment.
1.6.3 The doctors with heart pacemaker are forbidden to use this equipment.
1.6.4 Heart disease patients, pregnant women and children should be cautious to use
the equipment.
1.6.5 Patients with respiratory diseases such as asthma and chronic bronchitis are not
allowed to use this device.
1.6.6 Patients with a low-salt diet are prohibited from air polishing function.

3
1.7 Device safety classication
1.7.1 Classied by operation mode: Continuous operating device
1.7.2 Type of protection against electric shock: Class Ⅰ
1.7.3 Degree of protection against electric shock: B type applied part
1.7.4 Degree of protection against harmful ingress of water: Ordinary equipment
(IPX0). Foot pedal is anti-drip device (IPX1)
1.7.5 Degree of safety application in the presence of a ammable anesthetic mix-
ture with air, oxygen, or nitrous oxide: Equipment cannot be used in the presence of a
ammable anesthetic mixture with air, oxygen, or nitrous oxide.
1.8 Main technical specication
1.8.1 Power adapter input: 220-240V~ 50Hz/60Hz 400mA
1.8.2 Power adapter output: 25V~ 50Hz/60Hz 2.8A
1.8.3 Main unit input: 25V~ 50Hz/60Hz 2.8A
1.8.4 Output main vibration oset of tip (maximum): 90μm;
Deviation: +50%
1.8.5 Output vibrating frequency of tip: 30±5kHz
1.8.6 Output semi- (maximum)oset force: 5N Deviation: +50%
1.8.7 Output power of tip: 3W~20W
1.8.8 Main unit fuse: T5AH 250V
1.8.9 Power adapter fuse: T1.0AL250V
1.8.10 Water inlet pressure: 1bar~5bar (0.1MPa~0.5MPa)
1.8.11 Air inlet pressure: 5.5bar~7.5bar (0.55MPa~0.75MPa)
1.8.12 Water outlet temperature of air polishing system: 0~45℃
1.8.13 Main unit weight: 2.75Kg
1.8.14 Main unit size: 330mm×280mm×120mm
1.9 Operation environment
1.9.1 Environmental temperature: +5℃~ +40℃
1.9.2 Relative humidity: 30% ~ 75%
1.9.3 Atmospheric pressure: 70kPa~106kPa
1.9.4 Cooling water temperature: +5℃~ +25℃

4
2 Installation
2.1 Front view of the main unit
Figure 1 Front view of main unit
2.2 Rear view of the main unit
Figure 2 Rear view of the main unit

5
2.3 Touch panel
Ultrasonic scaling
Air polishing scaling
Cleaning mode
Scaling/supragingival air polishing
Perio/subgingival air polishing
Endodontic treatment
Turn down water volume/power/air pressure
Turn up water volume/power/air pressure

6
Setting
Figure 3 Schematic diagram of touch panel
2.3 Schematic diagram of handpiece
Figure 4 Ultrasonic handpiece
Figure 5 Air polishing handpiece
2.4 Schematic diagram of tip installations
Figure 6 Schematic diagram of tip installation

7
2.5 Installation procedures
① Open the package, check whether the equipment is complete as per the packing
list, and place the main unit on a solid plane, holding it directly facing the operator.
②Connect the power adapter with main unit.
③Plug the external air pipe connector into the air intake connector on the back of
the main unit.
Figure 7 Schematic diagram of external air pipe installation
④ Insert the foot pedal plug into the foot switch socket.
⑤ Connect the ultrasonic handpiece and air polishing handpiece with corresponding
tail cords respectively, and place the handpieces on the brackets on both sides of the
main unit. The ultrasonic handpiece is on the left and the air polishing handpiece is on
the right.
Warning1: When the machine is connected to the network power supply, the pro-
tec- tion ground must be linked.
Warning2: When the machine is connected to the network power supply,do not pla-
ce or install the product where it is dicult to disconnect thenetwork power supply.
3 Function and operation
3.1 Multi-function foot pedal
① According to the installation procedures, insert the foot pedal plug into the main
unit, tighten it, and place the foot pedal face up on a at surface.
② The multi-function pedal is as shown in the gure, and the functions of each but-
ton are as follows:
Button Working mode Function
Ultrasound system air polishing system
A Standard Vibration + water Air, powder + water
B Anhydrous mode Vibration Air only
C (+A) Enhance【Note】Power increases by
two levels
Air pressure increases by
two levels

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D Irrigation Only water spray Air+Water
【Note】In the Enhance mode, the power/air pressure is increased by three levels
based on the original level, and the maximum is level 12. When the pedal button C is re-
leased, the gear position is automatically restored to the previously set gear position.
Figure 8 Schematic diagram of multi-function foot pedal
3.2 Ultrasound system
3.2.1 Scaling
1. Install the product correctly according to the product installation steps, and the ope-
rator is facing the machine.
2. Turn on the power switch on the main unit and pick up the ultrasonic handpiece. At
this time, the panel automatically jumps into the Ultrasound system interface.
3. This machine uses the touch panel. Directly click the “G” on the panel to enter the
teeth scaling mode.
4. Select the appropriate water supply method and click on the water bottle/faucet icon
on the panel to switch between water bottle supply and external water.
5. Select proper tip as per need, and use torque wrench to tighten it to the handpiece.
6. When the foot button A is pressed, the tip vibrates, and the LED light on the head
of handpiece is illuminated, accompanied by the cooling water spray (For the rst time
after booting, as there is more air in the pipeline, it takes a few seconds to drain.) After
releasing the foot pedal, the vibration and water spray stop, and the LED light continues
to light for 10 seconds and then goes out.
7. Generally, hold the handpiece with the gesture of holding a pen.
8. The frequency of the tip is extremely high. In the condition of normal tip vibration
and water spray, lightly touch the tooth surface with the side of tip and move in a certain
to-and-fro motion to eliminate the calculus without obvious heating. Avoid local ove-

9
rexertion or overstay in scaling.
9. Vibrating intensity: Adjust the vibrating intensity according to your need. Generally
start with level 1 power, and adjust the vibrating intensity according to the teeth sensitivi-
ty and hardness of calculus during clinical application.
10. Water volume: For water bottle supply mode, click the water volume adjusting
knob on penal to adjust. For external water supply mode, adjust the water volume throu-
gh the water volume adjusting knob on the back of main unit.
11. In clinical scaling, please keep the side of the tip in contact with and parallel to the
tooth surface. Do not apply pressure so as to allow the tip to vibrate freely.
12. After operation, please keep device working for 30s with water supply to wash the
handpiece and tips.
13. Remove the tip for disinfection.
3.2.2 Ultrasonic periodontal treatment
1. Use a torque wrench to tighten the periodontal treatment tip to the ultrasonic han-
dpiece. Click the “P” key on panel to enter the periodontal treatment mode.
2. The rest of the operation and adjustment methods are similar to the ultrasonic sca-
ling mode.
3.2.3 Endodontic irrigation
1. Tighten the Endo le to the Ultrasonic handpiece with Endo wrench.
2. Click the “E” key on panel to enter the Endodontic irrigation mode.
3. After switching to the Endodontic irrigation mode, the default power level is level 1.
Select higher power level according actual need during clinical treatment.
4. Select the appropriate Endo le and slowly place it into the root canal of the pa-
tient’s teeth. Start the foot pedal to perform ultrasonic endodontic irrigation.
5. When the Endo le is in the root canal, please do not the press it too tight.
6. Only after the Endo le is in the root canal can the foot pedal can be activated.
7. The recommended power level of Endodontic irrigation is level 1 – level 5.
3.3 Air polishing system
1. Add appropriate amount of powder to the supragingival powder tank (the amount
of powder should to be controlled between the “Max” amount and “Min” amount on the
surface of the tank), then tighten the cover of powder tank and plug the powder tank into
the powder tank socket just above the device.
2. Pick up the air polishing handpiece, the panel automatically jumps to working inter-
face of air polishing mode.
3. Click the panel to adjust the water volume to the maximum level (level 12), adjust
the air pressure (POWER) to level 1, align the nozzle with the pool, and press the button
A on foot pedal to conrm whether the nozzle can normally emit gas, powder and water
mist. The device can be used later after the nozzle can normally emit gas, powder and
water mist.
4. Before air polishing treatment, please help patient to wear the goggles and give
patient a mask to cover the face or let. And the users should wear goggles or a protective
mask.

10
5. Generally, hold the handpiece with the gesture of holding a pen.
6. Adjust the water volume and air pressure to appropriate level. Normally the water
volume starts with level 5, and air pressure starts with level 1. During clinical applica-
tion, adjust the water volume and air pressure according to the teeth sensitivity and den-
tal plaque condition. Increase of air pressure will enhance the cleaning eect, but will
weaken the polishing eect. Increase of water volume will enhance the polishing eect,
but weaken the cleaning eect.
7. During scaling, align the nozzle with the tooth surface, but not directly contact it.
Keep it 3-5mm away from the tooth surface at the angle of 30°-60°. The smaller the an-
gle, the bigger the cleaning area will be. During scaling, please perform a small circular
motion on the tooth surface. Do not point the nozzle at the gums or periodontal parts.
8. The air/powder mixture reected from the tooth surface should be evacuated by
using a strong suction device on the dental unit during treatment.
9. After treatment, adjust the water volume to the maximum level, and polish the sur-
face of all teeth.
3.4 Cleaning mode
It is recommended to flush and disinfect the pipe of the unit daily. The Cleaning
mode allows the pipes to be cleaned and disinfected to reduce crystal accumulation and
the amount of bacteria in the pipe.
1. Fill the water bottle with distilled or dematerialized water.
2. Pick up the ultrasonic handpiece, point the handpiece at the sink, click the “Cle-
aning” button on the screen, and press the button D on foot pedal to start cleaning the
pipeline. At this time, the pedal can be released.
3. After cleaning for 30 seconds, the device will automatically stop the “Cleaning”
mode. You can also press the button D on foot pedal again in the “Cleaning” mode or
click “Purge” on the screen to stop cleaning.
4. After cleaning, put the ultrasonic handpiece back into the bracket. And then, pick
up the air polishing handpiece, point the handpiece nozzle at the pool, and click the
“Cleaning” button again, so that the device will automatically blow out the residual
powder in the pipeline and release the high pressure gas in powder tank.
5. After cleaning for 20 seconds, the device will automatically exit the “Cleaning”
mode. You can also click “Purge” on the screen to stop cleaning.
3.5 Function setting
Click the Setting key on the panel to enter the setting interface for language selec-
tion and the start or closure of heater. The power and water volume are automatically
restored to the gear positions set at the factory when you click the ‘Restore the factory
setting’.
3.6 Precautions
1. Please keep the device clean before and after operation.

11
2. Allow the machine to work with water for 10 seconds before each clinical opera-
tion to remove any water remaining in the pipe.
3. Operators should be equipped with adequate protection (e.g., goggles, masks,
etc.) to prevent cross-contamination.
4. Product use must comply with the relevant operation specications and relevant
regulations of the medical department. And the operation is limited to trained doctors or
technicians.
5. Before each operation, please disinfect the accessories such as ultrasonic handpie-
ce, tip, torque wrench, air polishing handpiece and nozzle.
6. Please do not load or unload the tip while stepping on the foot pedal or the han-
dpiece is vibrating.
7. Do not step on the foot pedal button while the tail cord of the air polishing han-
dpiece has been removed from the main unit.
8. Before using the ultrasonic handpiece, make sure that the tail cord of the air po-
lishing handpiece is correctly placed on the handpiece bracket; similarly, before using
the air polishing handpiece, make sure that the ultrasonic handpiece tail plug is cor-
rectly placed on the ultrasonic handpiece bracket.
9. The tip must be tightened.
10. When the tip is damaged or worn, the vibration intensity will decrease. The ope-
rator should replace it with a new one in time according to the clinical situation.
11. Do not bend or grind the tip.
12. If the equipment is used in the anhydrous mode for a while, the temperature of
the tip may be more than 51 °C. It is recommended that the tip continuously works for
2 seconds and pause for at least 15 seconds in the anhydrous mode.
13. Under no circumstances should the air polishing handpiece nozzle be aimed at
people.
14. If the powder accidentally sprays into the eyes, it may damage eyes. We strongly
recommend that all personnel (doctors, nurses, patients) wear goggles during air po-
lishing treatment.
15. During the air polishing process, if you need to add powder to the powder tank,
please click the “Cleaning” key on the screen, wait for the internal pressure of the pow-
der tank to be released, then remove the powder tank from the machine and load the
appropriate amount of powder.
16. Before replacing the air polishing handpiece or the nozzle, please use a syringe
to blow the moisture at the joints at both ends (especially the gas interface) to prevent
moisture from entering the gas path and avoid clogging of the powder in the pipeline.
17. Do not use unclean water.
18. If a pressureless water source is used, the water surface of the pressureless water
source should be more than one meter above the patient’s head.
19. Do not pull the tail cord hard during the use of the device to avoid damage to the
tail cord.

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20. Do not hit or scratch the handpiece.
21. After operation, turn o the power supply and unplug the power plug.
22. If there is any problem with the power adapter, please return it to the manufactu-
rer or have it repaired by an authorized professional.
23. Our company is specialized in the production of medical devices. Only when
the maintenance, repair and modication of the machine is carried out by our company
or our authorized dealer, the replacement parts are the Woodpecker accessories and the
operation is in accordance with the instruction manual, we are responsible for its securi-
ty.
24. The inner thread of the tip manufactured by certain manufacturers are rough,
rusty and will break the teeth or adopt other thread system, the combination between the
above mentioned inner thread with our handpiece will damage the outer thread of han-
dpiece, which will cause irreparable damage to the scaler. Please use corresponding tips
of the Woodpecker brand.
25. If you find that the sealing ring is damaged when using PT-A, please refer to
the annex Sealing Ring Specications in the Manual and get it replaced with suitable
sealing ring. There are seals of various specications in the supplied accessories. If you
have any questions, please contact the manufacturer or local distributor.
4 Troubleshooting
4.1 Troubleshooting
Fault Possible cause Solutions
The tip does not
vibrate and there
is no water spray
after power on and
stepping on the foot
pedal.
Loose contact of power supply
plug. Plug the power supply plug well.
Loose contact of foot pedal. Plug the foot pedal plug well.
The fuse is broken. Contact local distributor or
manufacturer.
The bracket switch does not
pop up.
Move the bracket switch to make
it pop up smoothly.
The tip does not
vibrate and there
is water spray
after power on and
stepping on the foot
pedal.
Loose tip Tighten the tip (gure 6)
The connection between the
tail wire and the circuit board is
loose.
Contact local distributor or
manufacturer.
Handpiece failure Contact local distributor or
manufacturer.
Tail cord failure Contact local distributor or
manufacturer.

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The tip vibrates but
there is no water
spray after power on
and stepping on the
foot pedal.
Water volume adjustment knob
is not open.
Open the water volume
adjustment knob. 【Note1】
Wrong selection of water
supply mode
Keep the water supply mode
displayed on screen consistent
with the actual water supply.
Filter clogging Clean the lter
Impurity in the solenoid valve Contact local distributor or
manufacturer.
Water line clogging Use syringe to drain.
After power-o,
there is still water
spray.
Impurity in the solenoid valve Contact local distributor or
manufacturer.
Heating handpiece
Water volume is too small Turn up the water volume.
【Note1】
Device fault Contact local distributor or
manufacturer.
The euent water
temperature is too
high (over 45 ° C)
Thermocouple failure Contact local distributor or
manufacturer.
Water spray is too
small
Water volume is too small Turn up the water volume.
【Note1】
Water pressure is not enough Increase the water pressure
Water line clogging Use syringe to drain.
Weakened tip
vibration
Tip is not tightened. Tighten the tip (Figure 6)
Tip is loose Tighten the tip (Figure 6)
Broken tip 【Note2】Replace the tip
The Endo le does
not vibrate The nut is not tightened Tighten the nut
There is no air spray
and water spray
after power on and
stepping on the foot
pedal.
Loose contact of power supply
plug. Plug the power supply plug well.
Loose contact of foot pedal. Plug the foot pedal plug well.
The bracket switch does not
pop up.
Move the bracket switch to make
it pop up smoothly.
The nozzle does
not spray gas but
there is water spray
after power on and
stepping on the foot
pedal.
Nozzle clogging Dredge the nozzle
Handpiece clogging Dredge the handpiece
Clogging of handpiece tail cord
Remove the tail cord from the
main unit, dredge the tail cord or
replace it.
Solenoid valve failure Contact local distributor or
manufacturer.

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There is air ow
but no water spray
after power on and
stepping on the foot
pedal.
Water volume adjustment knob
is not open.
Open the water volume
adjustment knob. 【Note1】
Wrong selection of water
supply mode
Keep the water supply mode
displayed on screen consistent
with the actual water supply.
Filter clogging Clean the lter
Impurity in the solenoid valve Contact local distributor or
manufacturer.
Water line clogging Contact local distributor or
manufacturer.
Leaking air of
powder tank
The O-ring on base of powder
tank is broken.
Contact local distributor or
manufacturer.
The rubber ring on upper cover
of powder tank is broken. Replace the rubber ring.
There is powder residue at the
thread, so that the screw is not
in place.
Remove the residual powder at
the thread part.
The upper cover of powder tank
is broken.
Replace the upper cover of
powder tank.
The thread of powder tank is
broken so that the screw is not
in place.
Replace the upper cover of
powder tank.
Water leakage of air
polishing handpiece Broken O-ring of handpiece Replace the O-ring
The air powder
scaling eciency is
reduced.
The powder in tank is not
enough. Add powder to the tank.
Powder residue in pipe,
handpiece, or nozzle passage
Clean the passage with a ne
needle and blow it o with
compressed air.
Touch panel pops up
prompt message
No powder chamber Check the powder chamber and
reinstall.
Insucient pressure Increase pressure of external air.
Do not take two handpieces at
the same time
Choose one handpiece when
working and put another one
back into the bracket.
Please adjust water volume by
the knob
Use the knob on the rear of main
unit to adjust water volume when
in the external water mode.
Heating system failure! Please
stop heating.
Turn o heating and contact
local distributor or manufacturer.
Note: if the problems cannot be solved, please contact local distributor or manufactu-
rer.

15
4.2 Notice
【Note1】As shown in the picture, the water volume can be increased or decrease
through adjusting the water volume adjustment knob.
【Note2】If the tip is surely tightened and there is water mist spray, the tip is consi-
dered to be damaged with the following phenomena:
1) The vibration intensity of the tip and the degree of water atomization are signi-
cantly weakened.
2) The tip makes a harsh “click” sound during operation.
5 Cleaning, disinfection, and sterilization
5.1 Initial processing
5.1.1 Processing principles
It is only possible to carry out eective sterilization after the completion of eective
cleaning and disinfection. Please ensure that, as part of your responsibility for the steri-
lity of products during use, only suciently validated equipment and product-specic
procedures are used for cleaning/disinfection and sterilization, and that the validated
parameters are adhered to during every cycle.
Please also observe the applicable legal requirements in your country as well as the
hygiene regulations of the hospital or clinic, especially with regard to the additional re-
quirements for the inactivation of prions.
5.1.2 Post-operative treatment
The post-operative treatment must be carried out immediately, no later than 30 mi-
nutes after the completion of the operation. The steps are as follows:
Let the device works for 20-30 seconds at maximum water volume to separately
ush the Ultrasonic handpiece, tip, Air polishing handpiece, and nozzle;
Remove the handpieces from the device and rinse away the dirt on the surface of
handpieces and their accessories (tip, nozzle and torque wrench) with pure water (or
distilled water/deionized water);
Dry the handpieces and its accessories with a clean, soft cloth and place it in a clean
tray.
Precautions:
1) The water used here must be pure water, distilled water or deionized water.
5.2 Cleaning
The cleaning of handpiece and its accessories should be performed no later than 24
hours after the operation.
The cleaning can be divided into automated cleaning and manual cleaning. Automa-
ted cleaning is preferred if conditions permit.
5.2.1 Automated cleaning
The cleaner is proved to be valid by FDA, CE certication or in accordance with EN
ISO 15883.

16
There should be a ushing connector connected to the inner cavity of the product.
The cleaning procedure is suitable for the handle, and the ushing period is su-
cient. But ultrasonic cleaning is not allowed for Ultrasonic handpiece.
It is recommended to use a washer-disinfector in accordance with EN ISO 15883.
For the specic procedure, please refer to the automated disinfection section in the sec-
tion “Disinfection”.
Precautions:
1) The cleaning agent does not have to be pure water. It can be distilled water, deio-
nized water or multi-enzyme. But please ensure that the selected cleaning agent is com-
patible with the handpiece.
2) The water temperature should not exceed 45℃, otherwise the protein will solidify
and it is dicult to remove.
5.2.2 Manual cleaning
· Soak the handpieces and its accessories in a cleaning agent (such as multi-enzyme).
The soaking time and concentration should at least reach the time and concentration
specied by the detergent manufacturer;
· Carefully clean the surface of the handpieces and its accessories with a disposable
soft cloth or soft brush to remove any visible dirt on the surface;
· Rinse the handpieces and its accessories under clean running water (desalted water,
distilled water or deionized water) for at least 5 times with duration of no less than 60
seconds for each time.
· Check whether the cleaned parts are clean or damaged. If the cleaning is not com-
plete, repeat the previous cleaning procedures.
The intrinsic suitability of the handpieces and its accessories for eective cleaning
using the above procedure was veried by a validated facility.
Precautions:
1) The cleaning agent used here must be compatible with the handpieces and only
freshly prepared solutions can be used.
2) The water temperature should not exceed 45℃, otherwise the protein will solidify
and it is dicult to remove.
5.3 Disinfection
Disinfection must be performed no later than 2 hours after the cleaning phase. Auto-
mated disinfection is preferred if conditions permit.
5.3.1 Automated disinfection
If possible, the disinfection cycle should be in accordance with EN ISO 15883. Plea-
se ensure that the following standards are met when selecting a sterilizer system:
• The sterilizer is FDA approved, CE certied or in accordance with EN ISO 15883.
• Use high temperature disinfection function. The temperature does not exceed 134 °
C. The temperature cannot exceed 20 minutes.
• The sterilizer has a ush connecting piece that is connected to the interior of the
handpiece.

17
• The cleaning procedure is suitable for the handle and the ushing cycle is sucient
(5-10 minutes).
• Only distilled or deionized water with a small amount of microorganisms (<10
cfu/ml) can be used for all rinsing steps. (For example, pure water that is in accordance
with the European Pharmacopoeia or the United States Pharmacopoeia).
• The air used for drying must be ltered by HEPA.
• Regularly repair and inspect the disinfector.
Cleaning and disinfecting steps by using Washer-disinfector
Carefully place the handpieces and its accessories in the disinfection basket. Faste-
ning of the handpieces and its accessories if only permissible of they are freely movea-
ble in the xture. The handpieces and its accessories are not permitted to make contact
with one another.
Use a suitable rinsing adaptor, and attach the handpieces to the rinsing connections
of the washer-disinfector so that the surface and internal water lines can be ushed du-
ring cleaning process.
Start the program.
After the program is nished, remove the handpieces and its accessories from the
washer-disinfector, inspect (refer to section “Inspection and Maintenance”) and packa-
ging (refer to chapter “Packaging”). Dry the handpieces and its accessories repeatedly
if necessary (refer to section “Drying”).
The intrinsic suitability of the handpieces and its accessories for eective cleaning
and disinfection using the above automated cleaning and disinfection procedures was
veried by a certied facility. (Use the washer-disinfector of Shandong Xinhua Medical
Instrument Co., Ltd. located in Zibo City, Shandong Province, which complies with EN
ISO 15883).
Precautions:
1) Before use, you must carefully read the operating instructions provided by the
equipment manufacturer to familiarize yourself with the disinfection process and pre-
cautions.
2) With this equipment, cleaning, disinfection and drying will be carried out toge-
ther.
3) Cleaning: (a) The water temperature should not exceed 45℃, otherwise the pro-
tein will solidify and it is dicult to remove. (b) The solution used can be pure water,
distilled water, deionized water or multi-enzyme solution, etc., and only freshly prepa-
red solutions can be used. (c) The cleaning agent must be compatible with the handpie-
ce. Please follow the concentration and contact time provided by manufacturer.
5.3.2 Manual disinfection
Tools: containers for disinfectant, water guns, air guns, trays
Place the handpieces and its accessories in a disinfectant (e.g.75% medical alcohol
or 2% glutaraldehyde solution) for at least the time specied by the manufacturer.
Remove the handpieces and its accessories from the disinfectant and rinse it with
puried water, distilled water or deionized water for at least 5 times for not less than 60

18
seconds of each time.
Dry the handpieces and its accessories with ltered compressed air (maximum pres-
sure: 3 bar).
After the program is nished, remove the handpieces and its accessories from the
washer-disinfector, inspect (refer to section “Inspection and Maintenance”) and packa-
ging (refer to chapter “Packaging”). Dry the handpieces and its accessories repeatedly if
necessary (refer to section “Drying”).
Verication of the fundamental suitability of the handpieces and its accessories for
eective manual cleaning and disinfection was provided by a veried testing laboratory.
Precautions:
1) The disinfectant used to congure the disinfectant must be compatible with the
handpieces and cleaning agent, and must be tested eective (e.g., DGHM, FDA appro-
ved or CE certied).
2) The disinfectant must be used in accordance with the concentration and contact
time specied by manufacturer.
3) The disinfectant used must be freshly prepared solutions and no foaming is
allowed.
5.4 Drying
If your cleaning and disinfection process does not have an automatic drying function,
dry it after cleaning and disinfection.
Methods:
1) Spread a clean white paper (white cloth) on the at table, point the handpieces and
its accessories against the white paper (white cloth), and then dry the handpieces and its
accessories with ltered dry compressed air (maximum pressure 3 bar). Until no liquid
is sprayed onto the white paper (white cloth), the drying is completed.
2) It can be dried directly in a medical drying cabinet (or oven). The recommended
drying temperature is 80℃~120℃ and the time should be 15~40 minutes.
Precautions:
1) The drying of product must be performed in a clean place.
2) The drying temperature should not exceed 138℃;
3) The equipment used should be inspected and maintained regularly.
5.5 Inspection and maintenance
1) Check the handpieces and its accessories. If there is still visible stain on the han-
dpieces and its accessories after cleaning/disinfection, the entire cleaning/disinfection
process must be repeated.
2) Check the handpieces and its accessories. If it is obviously damaged, smashed,
detached, corroded or bent, it must be scrapped and not allowed to continue to be used.
3) Check the handpiece. If the structural parts (O-ring, LED light, light guide, etc.)
are broken, please replace it before use. But the replaced parts must be cleaned, disin-
fected and dried.