AP-B

Dental Scaler and Air Polisher Instruction Manualc E:

Please read this manual before operating
0197

GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.
https://www.kadashika.jp

Contents
Preface....................................................................................................... 1
1 Introduction............................................................................................ 1
2 Installation and Operation...................................................................... 3
3 Troubleshooting................................................................................... 1 1
4 Cleaning, Disinfection and Sterilization.............................................. 1 35 Maintenance, storage and transportation............................................. 1 96 Environment protection....................................................................... 2 0
7 After service ........................................................................................ 2 1
8 European authorized representative..................................................... 2 1
9 Symbol instruction .............................................................................. 2 1
10 EMC-Declaration of conformity........................................................ 2 2
11 Statement............................................................................................ 2 7https://www.kadashika.jp

Preface
Guilin Woodpecker Medical Instrument Co., Ltd is a professional
manufacturer researching, developing, and producing dental products.
Woodpecker owns a sound quality control system and two brands,
Woodpecker and DTE. Its main products include dental scaler, dental
air polisher, Ultrasurgery, root canal motor, Curing light, dental
implant unit, endo motor, etc.

1 Introduction
AP-B dental scaler and air polisher has both ultrasonic system andairpolishing system. The device features include:
1) Automatically switch the working mode according to the selected
handpiece.
2) Water and power can be adjusted.
3) Special pharmaceutical products such as hydrogen peroxide,sodium hypochlorite and chlorhexidine can be used in automatic watersupply mode to improve clinical therapeutic effect.
4) Ultrasonic handpiece LED lights make clinical operation moreconvenient. Airpolishing handpiece adopts three-section design, whichis easy to load and unload, and convenient to clean and maintain.
5) The handpiece can be free to plug, and can be sterilized in theenvironment of 134°C and 0.22MPa pressure.

1.1 Product model
AP-B

1.2 Product Configuration

For more information, see packing list.

1.3 Structure and components

It mainly consists of main unit, ultrasonic handpiece, airpolishinghandpiece, tips, nozzle, foot switch, powder tank, water bottle, power
adapter, prophylaxis powder, etc.

1.4 Intended use

AP-B Dental Scaler and Air Polisher is suitable for periodontal
treatment and root canal irrigation in dental clinical treatment. It canremove supragingival and subgingval calculus and plaque, so as toachieve the therapeutic effect of consolidating periodontal tissue.

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1.5 Contraindication

1.5.1 The hemophilia patient is forbidden to use this device.
1.5.2 The patients with heart pacemaker are forbidden to use thisdevice.
1.5.3 The doctors with heart pacemaker are forbidden to use thisdevice.
1.5.4 Heart disease patients, pregnant women and children should becautious to use the device.
1.5.5 Patients with respiratory diseases such as asthma and chronic
bronchitis are not allowed to use this device.

1.6 Equipment security classification

1.6.1 Classification by operation mode: Continuous operating device
1.6.2 Type of protection against electric shock: Class Ⅰ
1.6.3 Degree of protection against electric shock: B type applied part
1.6.4 The contact duration time of applied part:
Tips: Less than 30 minutes
Nozzle: Less than 10 minutes
1.6.5 The temperature of the surface of nozzle may reach 45°C if it isused at maximum power.
1.6.6 Degree of protection against harmful ingress of water: Ordinary
equipment (IPX0). Foot switch is anti-drip device (IPX1).
1.6.7 Degree of safety application in the presence of a flammableanesthetic mixture with air, oxygen, or nitrous oxide: Equipment
cannot be used in the presence of a flammable anesthetic mixture withair, oxygen, or nitrous oxide.

1.7 Main technical specification

1.7.1 Power adapter input: 100-240V~ 50/60Hz 1.1A Model: USE48300130SPA3
1.7.2 Main unit input: 30V 1.3A
1.7.3 Main vibration offset of output tip (maximum):100μm,
deviation: ± 50%
1.7.4 Output tip vibration frequency: 30±5kHz
1.7.5 Output half offset force (maximum):10N deviation: ± 50%
1.7.6 Output power of tip: 3W ~ 20W
1.7.7 Main unit insurance: T1.6AL 250V
1.7.8 Air inlet pressure: 5.5bar ~ 7.5bar (0.55MPa ~ 0.75MPa)
1.7.9 Main unit weight:2.0kg
1.7.10 Main unit size: length×width×height 270mm×170mm×90mm

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1.8 Operation environment

1.8.1 Environment temperature: + 5°C ~ + 40°C
1.8.2 Relative humidity: 30% ~ 80%
1.8.3 Atmospheric pressure: 70kPa ~ 106kPa

1.9 Intended place of use

Professional healthcare facility environment.

2 Installation and Operation
2.1 Main unit and main accessories display
2.1.1 Front view of main unit

Fig. 1 Front view of main unit
2.1.2 Back view of main unit

2.1.3 Touch panel

Fig. 2 Back view of main unit3

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Fig. 3 Touch panel
After power on, the button will be blue. If there is no air connection or
the air pressure is insufficient, the blue light flashes.
2.1.4 Schematic diagram of handpiece

Figure 4 ultrasonic handpiece

Fig. 5 Airpolishing handpiece
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2.1.5 Installation diagram of tip

Figure 5 Installation diagram of tip

2.2 Main unit installation

1) Open the package, check whether all the accessories of thisequipment are complete according to the packing list, and put themain unit on the stable desktop to the operator.
2) Take out the foot switch and insert the connector into thecorresponding foot switch socket on the back of the main unit.
3) Take out the external air pipe and connect the air pipe joint with the
air inlet interface on the back of the main unit.
4) Put the power switch in the off state, insert the output plug of thepower adapter into the power socket on the back of the main unit, andthen insert the input plug of the power adapter into the power socket.
5) Release the foot pedal, the handle can stop working, and press thepower switch to shut down.
[Warning 1] To avoid the risk of electric shock, this equipment must
only be connected to a supply mains with protective earth.
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[Warning 2] when the power adapter is connected to the network
power supply, do not place or install the product in a place where it isdifficult to cut off the network power supply.
[Warning 3] Unauthorized modification of this equipment is notallowed.
[Warning 4] This equipment cannot be used in areas where liquids
may appear on the floor such as emergency rooms or surgicaloperating rooms.
[Warning 5] This equipment can only be used by professionals with aphysician or nurse license.
[Warning 6] The device is expected to be connected to anindependent power supply, and the power supply shall be specified aspart of the device or the combination of device and power supply shallbe specified as the ME system.
[Warning 7] Use of this equipment adjacent to or stacked with otherequipment should be avoided because it could result in improper
operation. If such use is necessary, this equipment and the otherequipment should be observed to verify that they are operating
normally.
[Warning 8] Use of accessories, transducers and cables other thanthose specified or provided by the manufacturer of this equipment
could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper
operation.

2.3 Instructions

2.3.1 Handpiece connection and disassembly
Take out the ultrasonic handpiece, install the tip on the handpiece withwrench, twist the wrench. Then connect the ultrasonic handpiece withthe ultrasonic line and put the handpiece on the bracket on the left sideof the main unit.
Take out the airpolishing handpiece, connect the air polishinghandpiece with the airpolishing line, and place the handpiece on thebracket on the right side of the main unit.
2.3.2 Filling with prophylaxis powder
Take out the powder tank and use the three way syringe to blow away
the residual powder. Take out the prophylaxis powder, hold the bottle
and shake it 3-5 times, then pour the powder into the powder tank.
When the powder in the powder tank is used up, please click the“Purging Mode” button twice to remove the compressed air in the6

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powder tank, and then add powder into powder tank. It is unallowed
to add powder when in use.
[Tip 1] Do not exceed the maximum (MAX) mark.
[Tip 2] The supragingival powder can only be used in the
supragingival powder tank. The subgingival powder can only be usedin the subgingival powder tank.
2.3.3 Filling with waterTake out the water bottle, add purified water (or distilled water) to thewater bottle, and then plug the water bottle into the main unit. A small
amount of Vaseline can be applied to the seal ring at the bottom of thewater bottle to lubricate the seal ring, which is convenient for thewater bottle to plug.
2.3.4 Scaling
2.3.4.1 Turn on the power switch of the main unit and pick up theultrasonic handpiece.
2.3.4.2 Assess the patient's oral condition, set the power and waterlevel in advance. It is recommended that the power starts from the
2nd gear, and the water volume starts from the 3rd gear. According
to the sensitivity and comprehensive situation of the patient's oralcavity, adjust the water and power level at any time during the scaling
process.
2.3.4.3 Select an appropriate tip as needed and tighten it on thehandpiece with the wrench.
2.3.4.4 Press on the foot switch, then the tip vibrates, LED on thehead of the handpiece lights, accompanied by water injection . Afterreleasing the foot switch, the vibration and water stops, and the LED
light continues to shine for 10 seconds and then goes out.
2.3.4.5 Hold the handpiece like holding a pen.
2.3.4.6 When the machine works normally, the frequency is extremely
high. Under the condition of ensuring tip vibrate normal, only sidesurface of tip should be used to gently touch the tooth surface andthere is no obvious fever in tip; Do not use too much force or stay too
long when scaling.
2.3.4.7 Please keep zero angular contact between the side of tip andthe tooth surface during scaling, and let the tip vibrate freely without
applying pressure.
2.3.4.8 After scaling, let the device work for 30 seconds with the water
to clean the handpiece and tip.
2.3.4.9 Remove tip for disinfection.
2.3.5 Air polishing7

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2.3.5.1 Assess the patient's oral condition, set the power and waterlevel in advance, and It is recommended that the power starts from the
2nd gear, and the water volume starts from the 3rd gear.
According to the sensitivity and comprehensive situation of thepatient's oral cavity, adjust the water and power level at any time
during the scaling process.
2.3.5.2 Before the treatment, please spray in the external containerfor 1-3 seconds in advance to ensure that the gas and water are evenly
sprayed.
2.3.5.3 Before air polishing, please wear goggles and veil. Users
should wear goggles or protective masks.
2.3.5.4 Hold the handpiece like holding a pen.
2.3.5.5 Make the nozzle align with the tooth surface. It is
recommended that the nozzle outlet keep a distance of 3-5mm fromthe tooth surface. It is recommended that the air polishing direction
and the tooth surface show an angle of 30 °-60 °, as shown in figure 6.
2.3.5.6 Use the high-speed evacuation equipment on the dental
comprehensive treatment machine to absorb the air/powder mixture
reflected from the tooth surface during treatment.

Fig. 6 schematic diagram of grit blasting on gum
2.3.5 Subgingival airpolishing
2.3.5.1 When the depth of the patient's periodontal pocket exceeds
4mm, subgingival airpolishing is recommended.
2.3.5.2 Install the nozzle before use, take out the nozzle assemble thenozzle to the end of the subgingival handpiece. Rotate the nozzle nut
to the head handpiece first, and then lock the nozzle with a wrench, asshown in Fig. 6.
2.3.5.3 Assess the periodontal condition of patients and set the power
and water level in advance. It is recommended that the power starts
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from the 1st gear and the water starts from the 3rd gear. Adjust
thewater and power level at any time during the scaling process.
saccording to the periodontal sensitivity and oral comprehensive
situation of patients.
2.3.5.4 Hold the handpiece like holding a pen.
2.3.5.5 It is recommended to use the nozzle to remove the plaque ofthe 4-9mm depth periodontal pocket, pull up and down when using.
2.3.5.6 It is not allowed to polishing the periodontal pocket at eachpoint for more than 5 seconds. [Tip 3] It is forbidden to pull out the
handpiece in the working state.
[Tip 4] When subgingival airpolishing, it’s just allowed use
subgingical powder, and misusing powder may cause harm to patients.

2.4 MaintenanceFig. 7 Nozzle locking

2.4.1 Air polishing handpiece
2.4.1.1 Remove the air polishing handpiece, loosen the handpiecehead and pull out the handpiece head (For subgingival handpiece, thenozzle needs to be removed in advance), as shown in figure 8.
2.4.1.2 Align the handpiece head with a three way syringe and blow
away the residual powder in the handpiece.
2.4.1.3 Blow the front and rear ends of the handpiece with a three way
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syringe.
2.4.1.4 If the handpiece is blocked, use needle to dredge it.
2.4.1.5 Handpieces, water bottles and powder tanks should not be
maintained when they are being used.

Fig. 8 handpiece cleaning diagram
2.4.2 Powder tank
2.4.2.1 It is recommended to estimate the amount of prophylaxis
powder before use. It is easy to cause blocked that leaving extra
powder in the powder tank for a long time because the powder willclump in a humid environment. Therefore, please pour out the powder
remaining in the powder tank after use.
2.4.2.2 Before turning off the device every day, please use an air gun
to blow off the powder remaining in the powder tank, and blow off
the powder on the threads of the powder tank and the threads of thepowder tank cover. The powder tank that have not been cleaned for along time may reduce the efficiency of airpolishing, and the residual
powder at the threads will affect the sealing performance of thepowder tank and the smoothness of the upper cover screwing.
2.4.3 Daily maintenance2.4.3.1 Before and after using airpolishing system, please click the"Purging Mode" button on the main unit twice and the device willenter into purging mode. The purging mode duration is 20 seconds,
and then stops automatically.
[Tip 5] If powder needs to be added during use, please click the"purging mode" button twice to release the high-pressure air in the
powder tank to prevent powder spraying from the bottom of thepowder tank when the powder tank is unplugged.
2.4.3.2 If the liquid medicine is used during the treatment, then after
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the treatment is completed, you must fill the water bottle with purewater (or distilled water), pick up the handpiece and press the footpedal to let the water flow out of the handpiece to flush the pipe forat least 1 minute. The chemical liquid remaining in the pipeline willcause corrosion of metal parts such as joints and solenoid valves.

3 Troubleshooting
FailurePress foot switch, thetip does not vibrate
and no water sprays

Possible cause
Solutions
Poor contact of power Plug in the power plug
plug.
well
Poor contact of power Plug in the power plug
plug.
well
Bracket switch does
Toggle bracket switch to
not pop up.
make it pop up smoothly
Press foot switch, the The tip is not tightened. Tighten work tip
tip does not vibrate but The connection plugContact local distributors
water sprays out.
or manufacturer.
between the tail line
and the circuit board isloose.
Handpiece failure.
Contact local distributors
or manufacturer.
Press foot switch, the Impurities in solenoid Contact local distributors
tip vibrates but novalve.
or manufacturer.
water spray.
Waterway blockage.
Use three-way syringe todredge waterway
After power-off, there Impurity in the solenoid Contact local distributors
is still water spray.
valve.
or manufacturer.

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Check the air connection
Unconnected air source and ensure that theor low air pressure (≤ pressure meets the3bar).
requirements of thedevice (5bar-7bar).
Use nozzle to dredge
Handpiece blocked.
handpiece.
There is air flow but
Contact local distributors
no water spray.
Tail line blocked.
or manufacturer.
The internal pipeline
Contact local distributorsof the main unit isor manufacturer.
blocked.
Contact local distributors
Solenoid valve failure.
or manufacturer.
The powder adheresto the inner wall of theDisassemble the powder
powder tank after being
tank and reinstall it after
damp, which affects
cleaning and drying.
the normal flow of thepowder.
There is air and water
The supragingival
spray, but no powder.
powder tank should be
Incorrect match
match with supragingicalbetween powder
powder. The subgingival
tank and prophylaxis
powder tank should be
powder.
match with subgingicalpowder.
Contact local distributors
Solenoid valve failure.
or manufacturer.
There is air spray but
Open the main unit
no water.
Solenoid Valve blocked dredge solenoid valve orcontact local distributors
due to impurities.
or manufacturer.
Abnormal foot switch
Reconnect foot switch.
connection.
There is no air andwater spray.
Repair or replace footFoot failure.
switch.
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Seal ring damaged.
Replace seal ring.
The upper cover of
Powder tank leakage
Re-screw the upper
the powder tank is notcover.
screwed in place.
Tail line seal ring
Airpolishing handpiecedamaged, deformed or Replace seal ring.
leakage.
missing.
Handpiece plug
Handpiece snap ring
Replace snap ring.
difficult.
deformation
Note: If the fault cannot be removed, please contact your local distributor
or manufacturer.

4 Cleaning, Disinfection and Sterilization
4.1 Initial processing

4.1.1 Processing principles
It is only possible to carry out effective sterilization after thecompletion of effective cleaning and disinfection. Please ensure that,as part of your responsibility for the sterility of products during use,
only sufficiently validated device and product-specific procedures areused 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, especiallywith regard to the additional requirements for the inactivation ofprions.
4.1.2 Post-operative treatment
The post-operative treatment must be carried out immediately, no later
than 30 minutes after the completion of the operation. The steps are as
follows:
Let the device works for 20-30 seconds at maximum water volume toseparately flush the Air polishing handpiece, and nozzle;
Remove the handpieces from the device and rinse away the dirt on
the surface of handpieces and their accessories with pure water (ordistilled water/deionized water);Dry the handpieces and its accessories with a clean, soft cloth andplace it in a clean tray.
Precautions:1) The water used here must be pure water, distilled water or deionizedwater.
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4.2 Cleaning

The cleaning of handpiece and its accessories should be performed nolater than 24 hours after the operation.
The cleaning can be divided into automated cleaning and manual
cleaning. Automated cleaning is preferred if conditions permit.
4.2.1 Automated cleaning
The cleaner is proved to be valid by FDA, CE certification or inaccordance with EN ISO 15883.
There should be a flushing connector connected to the inner cavity ofthe product.
The cleaning procedure is suitable for the handle, and the flushing
period is sufficient.
It is recommended to use a washer-disinfector in accordance with EN
ISO 15883.
For the specific procedure, please refer to the automated disinfection
section in the section “Disinfection”.
Precautions:1) The cleaning agent does not have to be pure water. It can be
distilled water, deionized water or multi-enzyme. But please ensurethat the selected cleaning agent is compatible with the handpiece.
2) The water temperature should not exceed 45°C, otherwise theprotein will solidify and it is difficult to remove.
4.2.2 Manual cleaning• Soak the handpieces and its accessories in a cleaning agent (suchas multi-enzyme). The soaking time and concentration should atleast reach the time and concentration specified by the detergent
manufacturer;• Carefully clean the surface of the handpieces and its accessories witha disposable soft cloth or soft brush to remove any visible dirt on thesurface;• 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 thecleaning is not complete, repeat the previous cleaning procedures. The
intrinsic suitability of the handpieces and its accessories for effective
cleaning using the above procedure was verified by a validated
facility.
Precautions:14

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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°C, otherwise theprotein will solidify and it is difficult to remove.

4.3 Disinfection

Disinfection must be performed no later than 2 hours after the cleaningphase. Automated disinfection is preferred if conditions permit.
4.3.1 Automated disinfection
If possible, the disinfection cycle should be in accordance with EN
ISO 15883. Please ensure that the following standards are met whenselecting a sterilizer system:• The sterilizer is FDA approved, CE certified or in accordance withEN ISO 15883.
• Use high temperature disinfection function. The temperature does
not exceed 134 °C. The temperature cannot exceed 20 minutes.
• The sterilizer has a flush connecting piece that is connected to theinterior of the handpiece.
• The cleaning procedure is suitable for the handle and the flushingcycle is sufficient (5-10 minutes).
• Only distilled or deionized water with a small amount of
microorganisms (<10cfu/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 filtered 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.
Fastening of the handpieces and its accessories if only permissibleof they are freely moveable in the fixture. The handpieces and its
accessories are not permitted to make contact with one another.
Use a suitable rinsing adaptor, and attach the handpieces to therinsingconnections of the washer-disinfector so that the surface andinternal water lines can be flushed during cleaning process.
Start the program.
After the program is finished, remove the handpieces and its
accessories from the asher-disinfector, inspect (refer to section“Inspection and Maintenance”) and packaging (refer to chapter“Packaging”). Dry the handpieces and its accessories repeatedly ifnecessary (refer to section “Drying”).
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The intrinsic suitability of the handpieces and its accessories for
effective cleaning and disinfection using the above automated cleaningand disinfection procedures was verified by a certified facility. (Usethe washer-disinfector of Shandong Xinhua Medical Instrument Co.,
Ltd. located in Zibo City, Shandong Province, which complies withEN ISO 15883).
Precautions:1) Before use, you must carefully read the operating instructions
provided by the device manufacturer to familiarize yourself with thedisinfection process and precautions.
2) With this device, cleaning, disinfection and drying will be carriedout together.
3) Cleaning: (a) The water temperature should not exceed 45°C,
otherwise the protein will solidify and it is difficult to remove. (b)The solution used can be pure water, distilled water, deionized wateror multi-enzyme solution, etc., and only freshly prepared solutions
can be used. (c) The cleaning agent must be compatible with the
handpiece. Please follow the concentration and contact time provided
by manufacturer.
4.3.2 Manual disinfection
Tools: containers for disinfectant, water guns, air guns, trays Placethe handpieces and its accessories in a disinfectant (e.g.75% medical
alcohol or 2% glutaraldehyde solution) for at least the time specified
by the manufacturer. Remove the handpieces and its accessories
from the disinfectant and rinse it with purified water, distilled wateror deionized water for at least 5 times for not less than 60 seconds ofeach time.
Dry the handpieces and its accessories with filtered compressed air(maximum pressure: 3 bar).
After the program is finished, remove the handpieces and its
accessories from the washer-disinfector, inspect (refer to section“Inspection and Maintenance”) and packaging (refer to chapter“Packaging”). Dry the handpieces and its accessories repeatedly ifnecessary (refer to section “Drying”).
Verification of the fundamental suitability of the handpieces andits accessories for effective manual cleaning and disinfection wasprovided by a verified testing laboratory.
Precautions:1) The disinfectant used to configure the disinfectant must becompatible with the handpieces and cleaning agent, and must be tested
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effective (e.g., DGHM, FDA approved or CE certified).
2) The disinfectant must be used in accordance with the concentrationand contact time specified by manufacturer.
3) The disinfectant used must be freshly prepared solutions and no
foaming is allowed.

4.4 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 flat table, point the
handpieces and its accessories against the white paper (white cloth),and then dry the handpieces and its accessories with filtered drycompressed air (maximum pressure 3 bar). Until no liquid is sprayedonto 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°C~120°C and the time shouldbe 15~40 minutes.
Precautions:1) The drying of product must be performed in a clean place.
2) The drying temperature should not exceed 138°C;
3) The device used should be inspected and maintained regularly.

4.5 Inspection and maintenance

1) Check the handpieces and its accessories. If there is still visible
stain on the handpieces 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 scrappedand not allowed to continue to be used.
3) Check the handpiece. If the structural parts are broken, please
replace it before use. But the replaced parts must be cleaned,disinfected and dried.
5) Do not use the machine when the machine is being cleaned/disinfected/sterilized.

4.6 Packaging

The disinfected and dried handpieces and their accessories areassembled and quickly packaged in a medical sterilization bag (orspecial holder, sterile box).
Precautions:1) The package used conforms to ISO 11607;
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2) It can withstand high temperature of 138°C and has sufficient steam
permeability;3) The packaging environment and related tools must be cleaned
regularly to ensure cleanliness and prevent the introduction ofcontaminants;
4) Avoid contact with parts of different metals when packaging.

4.7 Sterilization

Use only the following steam sterilization procedures (fractional prevacuum procedure*) for sterilization, and other sterilization
procedures are prohibited:
The steam sterilizer complies with EN13060 or is certified according
to EN 285 to comply with EN ISO 17665;
The highest sterilization temperature is 138°C;
The sterilization time is at least 4 minutes at a temperature of 132°C /134°C and a pressure of 2.0 bar ~ 2.3 bars.
Allow a maximum sterilization time of 20 minutes at 134°C.
Verification of the fundamental suitability of the products for
effectivesteam sterilization was provided by a verified testinglaboratory.
Precautions:1) Only products that have been effectively cleaned and disinfected
are allowed to be sterilized;
2) Before using the sterilizer for sterilization, read the Instruction
Manual provided by the device manufacturer and follow the
instructions.
3) Do not use hot air sterilization and radiation sterilization as thismay result in damage to the product;
4) Please use the recommended sterilization procedures forsterilization. It is not recommended to sterilize with other sterilization
procedures such as ethylene oxide, formaldehyde and low temperatureplasma sterilization. The manufacturer assumes no responsibility
for the procedures that have not been recommended. If you use thesterilization procedures that have not been recommended, pleaseadhere to related effective standards and verify the suitability andeffectiveness.
*Fractionation pre-vacuum procedure: a procedure for steam
sterilization by repeating pre-vacuum, the procedure used here is
steam sterilized by three pre-vacuums.

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5 Maintenance, storage and transportation
5.1 Maintenance5.1.1 It is recommended to install air drying device (such as freezing
dryer) in advance before using air polishing device. And check drying
device every day to ensure it work normally. Otherwise it may be easy
to cause prophylaxis powder agglomerating. And the agglomerating
will cause the device or handpiece blocked.
5.1.2 Check sealing ring on the handpiece, tail line, powder tank,water bottle regularly. If finding defects such as rupture, deformation
or falling off, please refer to the instructions and replace them in time,
the accessories are equipped with sealing rings of corresponding
specifications.
5.1.3 Check the air inlet interface filter once a month to confirm
whether there is impurity in the filter. If there is impurity, replace
the filter in time, and check the cleanliness of the air compressor
and the environment where it is located. If there is no impurity, it isrecommended to replace the filter every 24 months. Spare filters areincluded in accessories. The way to replace filter are shown in Figure 9.

5.2 Storage

Fig. 8 Schematic diagram of filter replacement

5.2.1 This device should be carefully placed away from the source,and should be installed or stored in a cool, dry and ventilated place.
5.2.2 Do not mix with toxic, corrosive, flammable and explosive
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articles during storage.
5.2.3 The product should be stored in an environment where therelative humidity is 10% ~ 93%, the atmospheric pressure is 70kPa ~106kPa, and the temperature is -20°C ~ + 55°C.
5.2.4 When this device is not in use for a long time, it should bepowered on and ventilated once a month, at least five minutes eachtime.

5.3 Transportation

5.3.1 Excessive impact and shake should be prevented duringtransport. Lay it carefully and lightly.
5.3.2 Do not put it together with dangerous goods during transport.
5.3.3 Avoid being exposed to sun, rain, and snow during transport.

6 Environment protection
Please discard waste, debris and expired machines or components inaccordance with local regulations.
Toxic or harmful substances or elements
Part

Main unit

(Pb)

(Hg)

(Cd)

(Cr6+)(PBB)(PBDE)

○

○

○

○

○

○

Motor
○
○
○
○
○
○
handpiece
Dental contra○
○
○
○
○
○
angle
Mechanicalelements,
including bolts,
○
○
○
○
○
○
nuts, washers,etc.
○: Indicates that the content of the toxic substance in all homogeneousmaterials of the part is below the limit requirement stipulated in SJ/T-113632006 Limit Requirements for Toxic and Hazardous Substances in Electronic
Information Products.
×: indicates that the content of the toxic substance in at least one of thehomogeneous materials of the part exceeds the limit requirement specified in
SJ/T-11363-2006. Please dispose according to the local laws or consult withdealer from whom you purchased it about waste disposal.
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7 After service
We offer one year free repair to the device according to the warranty
card. The repair of the device should be carried out by professional
technician. We are not responsible for any irretrievable damage
caused by non-professional person. This product is a precision device.
If there is problem that needs to be repaired, returned to Woodpecker
or handled by professionals is recommended. If any component
part needs to be replaced, please contact Woodpecker for relevant
information. Please use accessories or component parts provided orapproved by Woodpecker. Using other accessories or component parts
may cause equipment failure and unacceptable risks.

8 European authorized representative

9 Symbol instruction
Follow Instructions
for UseCE marked product

Date of manufacture

Manufacturer

Type B applied part

RecoveryHandle with care

Keep dry

Ordinary device

Anti-drip device

Used indoor only

Purging mode

Alternating current

Foot switch

Protective earthing

Sterilization under hightemperaturePower Switch

30V DC

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Cooling water orflushing water

Direct current

Appliance compliance WEEE directive
Storage condition, humidity limit: 10% ~ 93%
Storage condition, air pressure limit: 70kPa ~ 106kPa
Storage condition, temperature limit: -20°C ~ +55°C

10 EMC-Declaration of conformity
A list of all cables are replaceable by the RESPONSIBLE
ORGANIZATION :Cable maximum
Port No.
Name
Type*
lengths1
Enclosure
N/E—
2
AC Mains
AC power port
1.5m
Ultrasonic handpiece PATIENT
3
1.5m
Cable
COUPLING PORT
Airpolishing
PATIENT41.7m
handpiece Cable
COUPLING PORT
5
FOOT sw. Cable
SIP / SOP PORT
2.4m
6DC Mains of adapter DC power port
1.5m
Guidance and manufacturer’s declaration - electromagnetic emissions
The model AP-B is intended for use in the electromagnetic environment
specified below. The customer or the user of the model AP-B should assure that
it is used in such an environment.
Emissions test

ComplianceElectromagnetic environment guidance

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RF emissions
CISPR 11

The model AP-B RF energy
only for its internal function.
Therefore, its RF emissions
are very low and are not likely
to cause any interference innearby electronic equipment.

Group 1

RF emissions
CISPR11
Harmonic emissionslEC 61000-3-2
Voltage fluctuations /flicker emissionslEC 61000-3-3Class BThe model AP-B RF energy
only for its internal function.
Therefore, its RF emissions arevery low and are not
likely to cause any interferencein nearby electronic equipment.

Class A
Complies

Guidance & Declaration — electromagnetic immunity
The model AP-B 1s intended for use 1n the electromagnetic environment
specified below. The customer or the user of the model AP-B should assure that
It is used in such an environment.
IEC 60601
test level
Electrostatic± 8 kV contact
discharge (ESD) ± 15 kV airlEC 61000-4-2
Immunity test

Electrical fasttransient/burst
IEC 61000-4-4
Surge
lEC 61000-4-5Compliance level± 8 kV contact± 15 kV air±2kV for power ± 2kV for power
supply lines
supply lines±1kV for Input/ ± 1kV for
output lines
interconnectingcable± 1 kV line to Line-to-line--lie± 0,5 kV, ± 1 kV
± 2 kV line oLine-to-ground--earth± 0,5 kV, ± 1 kV,± 2 kVElectromagnetic
environment - guidance
Floors should be wood,concrete or ceramic tile
If floors are covered withsynthetic material, therelative humidity should
be at least 30 %.
Mains power quality
should be that of atypical commercial or
hospital environment.
Mains power quality
should be that of atypical commercial or
hospital environment.

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0 % UT; 0,5 cycle Mains power quality
0 % UT; 0,5
should be that of acycle At 0°, 45°, At 0°, 45°, 90°,90°, 135°, 180°, 135°, 180°, 225°, typical commercial or
hospital environment
225°, 270° and 270° and 315°
0 % UT; 1 cycle If the user of the model315°
require continued
0 % UT; 1 cycle and
70 % UT; 25/30 operation during powerandmains interruptions, it is
70 % UT; 25/30 cycles
Single phase: at 0° recommended that thecyclesSingle phase: at 0 % UT; 250/300 model be powered froman uninterruptible power
cycle
0°
adapter or a battery.
0 % UT;
250/300 cycle
Power frequency 30 A/m, 50 Hz 30 A/m, 50 Hz and Power frequency(50/60 H)
and 60 Hz
60 Hz
magnetic fields should
magnetic field
be at levels charactenst1c
IEC 61000-4-8
of a typical location ina typical commercial or
hospital environment.
NOTE UT is the ac mains voltage prior to application of the test level.
Voltage
dips, shortinterruptionsand voltage
variations on
power supply
input lines IEC
61000--11

Guidance & Declaration - Electromagnetic immunity
The model AP-B is intended for use in the electromagnetic environment
specified below. The customer or the user of the model AP-B should assure that
it is used in such an environment.
IEC 60601 test
ComplianceElectromagnetic
Immunity test
level
level
environment - guidance

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Portable and mobile

Conducted RF
lEC 61000-4-6
Conducted RF
lEC 61000-4-6
Radiated RF
lEC 61000-4-3

3 V, 0.15 MHz – 80 RF communications
MHz, 6 V in ISM equipment should be
used no closer to any
3 V, 0.15 MHz – 80 bands between
part of the models AP-B,
0.15 MHz – 80
MHz, 6 V in ISM
bands between 0.15 MHz, 80 % AM at including cables, than therecommended separation
MHz – 80 MHz, 80 1 kHz
3 V/m and 10 V/ distance calculated from% AM at 1 kHz
3 V/m and 10 V/m, m, 80 MHz – 2,7 the equation applicable
80 MHz – 2,7 GHz, GHz, 80 % AM at to the frequency of thetransmitter.
80 % AM at 1 kHz 1 kHz
Recommended separation
385 MHz, pulse
385 MHz, pulse
modulation 18 Hz, modulation 18 Hz, distance 1/2
d=1.2×P
27 V/m;27 V/m;
1/2
450 MHz, FM +/- 5 450 MHz, FM +/- d=2×P 1/2
kHz deviation 1 kHz 5 kHz deviation 1 d=1.2×P 80 MHz to 800
kHz sine, 28 V/m; MHz
sine, 28 V/m;
d=2.3×P1/2 800 MHz to710 MHz, 745 MHz, 710 MHz, 745
2.7 GHz
MHz, 780 MHz,780 MHz, pulse
modulation 217 pulse modulation where P is the maximum
output power rating of
217 Hz, 9 V/m;
Hz, 9 V/m;the transmitter In watts
810 MHz, 870 MHz, 810 MHz, 870(W) according to theMHz, 930 MHz,
930 MHz, pulse
transmitter manufacturer
modulation 18 Hz, pulse
modulation 18 Hz, and d Is the recommended
28 V/m;separation distance in
1,720 MHz, 1,845 28 V/m;
MHz, 1,970 MHz, 1,720 MHz, 1,845 meters (m).
MHz, 1,970 MHz, Field strengths frompulse
fixed RF transmitters,
modulation 217 Hz, pulse
as determined by an
modulation 217
28 V/m;electromagnetic siteHz, 28 V/m;
2,450 MHz, pulse
modulation 217 Hz, 2,450 MHz, pulse survey,a should be lessthan the compliance level
modulation 217
28 V/m;in each frequency range.b5,240 MHz, 5,500 Hz, 28 V/m;
MHz, 5,785 MHz, 5,240 MHz, 5,500 Interference may occur In
MHz, 5,785 MHz, the vicinity of equipment
pulse modulation
pulse modulation marked with the following
217 Hz, 9 V/msymbol:217 Hz, 9 V/m

NOTE 1 At 80 MHz - 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects andpeople.
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a Field strengths from fixed transmitters, such as base stations for radio (cellular/
cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due tofixed RF transmitters, an electromagnetic site survey should be considered. If
the measured field strength in the location in which the model is used exceeds
the applicable RF compliance level above, the model should be observed toverify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the model.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less
than
3V/m.
Recommended separation distances between
portable and mobile RF communications equipment and the model
The model is intended for use in electromagnetic environment in which radiatedRF disturbances is controlled. The customer or the user of the model can help
prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) andthe model is recommended below, according to the maximum output power ofthe communications equipment.
Separation distance according to frequency of transmitter
Rated maximumm
output power
800MHz toof transmitter
150kHz to 80MHz 80MHz to 800MHz
2,7GHzW
d=1.2×P1/2
d=1.2×P1/2
d=2.3×P1/2
0,01
0.12
0.12
0.23
0,1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, therecommended separation distance d in meters (m) can be estimated using theequation applicable to the frequency of the transmitter, where P is the maximum
output power rating of the transmitter in watts (W) accordable to the transmitter
manufacture.
NOTE I At 80 MHz - 800 MHz, the separation distance for the higher frequency
rane applies.
NOTE II These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects andpeople.

The device has been tested and homologated in accordance with EN
60601-1-2 for EMC. This does not guarantee in any way that this26

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device will not be affected by electromagnetic interference Avoid
using the device in high electromagnetic environment.

11 Statement
Woodpecker reserves the right to change the design of the device,
the technique, fittings, instruction manual and the content of theoriginal packing list at any time without further notice. The pictures
are only for reference. The final interpretation rights belong to Guilin
Woodpecker Medical Instrument Co., Ltd. The appearance of the
product was authorized patent, and counterfeit will be sued! (Pleaserefer to the packaging label for the date of manufacture. Service life:
10 years)

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ZMN-SM-491 V1.0-20220222

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