WOODPECKER D600 LED Ultrasonic Scaler Instruction Manual

WOODPECKER D600 LED Ultrasonic Scaler

The installation and components of equipment

Instruction
Guilin Woodpecker Medical Instrument Co., Ltd. is a professional manufacturer in researching, developing and producing ultrasonic scalers. The product is mainly used for teeth cleaning and also an indisensable equipment for teeth disease prevention and treatment.
The ultrasonic scaler D600 LED has scaling, perio functions with the following features:

• The handpiece can be autoclaved to high temperature 134°C and high pressure 0.22Mpa.
• Automatic frequency tracking ensures that the machine always works on the best frequency and more steadily.
• Digital control, easy operation and more efficient for scaling.

Components
The components of machine are listed in the packing list.

Product performance and structural composition
Ultrasonic scaler D600 LED is composed of electrocircuit, water way and ultrasonic transducer.

Scope of application
Ultrasonic scaler D600 LED is used for the dental calculus elimination and root canal treatment.

The main technical specifications

Technical specifications of ultrasonic scaler

• Main unit input: 220-240V~ 50Hz/60Hz 150mA
• Output primary tip vibration excursion: ≤90μm
• Output half-excursion force: <2N
• Output tip vibration frequency: 28kHz±3kHz
• Output power: 3W to 20W
• Main unit fuse: T0.5AL 250V
• Water pressure: 0.01MPa to 0.5MPa
• Weight of main unit: 1.8kg
• Operating mode: Continuous operation
• Type of protection against electric shock: class II equipment
• Degree of protection against electric shock: Type BF applied part
• Applied part of the equipment: handpiece and tip
• Degree of protection against harmful ingress of water: Ordinary equipment, the foot switch is drip-proof equipment (IPX1)
• Degree of safety of application in the presence of a Flammable Anesthetic Mixture with air, Oxygen or Nitrous Oxide: Equipment not suitable for being used in the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide.

Instruction of the main components

Instruction and component sketch map
Front of the main unit sketch map

Back of the main unit sketch map

Instruction of using a wrench

Installation and adjustment

Operation
Open the packing box, make sure that all the parts and accessories are complete according to the packing list, take the main unit out of the box, and put it on the the stable plane facing to the operator.

• Turn the water control knob to the max according to the picture 1 direction, Do not screw it over tight in case of damage. [ note 1]
• Insert the plug of the foot switch to its socket. (see picture 2)
• Connect one end of the water pipe to the water entrance, and the other end to the clean water sourse. (see picture 2)
• Choose the scaling tip according to the requirement, and fix the scaling tip with the wrench. ( see picture 4)
• Turn on the power switch, the power indicator lighted and the machine is ready for work. Touch panel is applied to this machine, water supply mode or power can be adjusted by directly touching the water supply mode identification or power indicator on the touch panel.
• Under normal working condition, the frequency of the tips is very high, light touch and a certain to-and-from motion will eliminate the tartar without obvious heating, overexetion and overatay are forbidden.
• Vibrating intensity: Adjust the vibrating intensity according to your need, usually adjust to the middle grade, and adjust the vibrating during the clinical treatment according to the patient’s sensitivity and the rigidity of the tartar.
• Step on the foot switch, the tip begins to vibrate, and the LED lamp on the top of the handpiece shines.
• Release the foot switch, the LED lamp keep shining for 10 seconds.
• Water volume adjustment: Step on the foot switch, and the tip begins to vibrate, then turn the water control switch to fine spray to cool down the handpiece and clean the teeth.
• The handpiece can be handled in the same gesture as a pen in hand.
• Be sure not to make the end of the tip touch the teeth vertically, and not use too much pressure when the tip touch the surface of the teeth, in order not to hurt the teeth and the tip.
• After finishing operation, keep the machine working for 30 seconds with the water supply to clean the handpiece and the tip.
• Unscrew the scaling tip and sterilize it.

Note: Don’t screw the scaling tips when stepping on the foot switch, and the machine is working.

Cleaning mode

It is suggested to wash and disinfect the water pipe after scaling everyday. The “Cleaning mode” can wash and disinfect the water pipe, reducing the crystal substance and bacterias in water pipe.
Operation:

1. Put distilled water or mineral substance into water tank.
2. Press the automatically water supply button and outside water button at the same time (1s) to start the “Cleaning mode” after buzzer beeps. The button of automatic water supply mode would flashes and others buttons will go out.
3. Link the connector and the handpiece with the drainage device.
4. Step the pedal, the device would start self-cleaning. After that the pedal could be loosen.
5. After cleaning for 30s, the device would stop self-cleaning. Or u can stop by step the pedal again or press the automatic water supply button.
6. After cleaning, press the automatically water supply button and outside water button at the same time (1s) to exit the “Cleaning mode” after buzzer beeps.

Maintenance

Troubleshooting

The scaling tip doesn’t vibrate and there is no water flowing out when stepping on the foot switch.| The power plug is in loose

contact.

| Make the plug insert to

the socket well.

The foot switch is in loose

contact.

| Insert the foot switch to

its socket tightly.

The fuse in the main unit is

broken.

| Contact our dealers or us.
Fault| Possible cause| Solutions
---|---|---

The scaling tip doesn’t vibrate but there is water flowing out when stepping on the switch.

|

The tip is in loose contact.

| Screw the tip on the handpiece tightly (See Picture 6).
The connect plug between the handpiece and the circuit

board is in loose contact.

|

Contact our dealers or us.

Something wrong with the

handpiece.

| Send the handpiece to our

company to repair.

Something wrong with the

cable.

| Contact our dealers or us.
The scaling tip vibrates but there is no spray when stepping on the foot switch.|

The water control knob is not on.

|

Turn on the water contrl knob [note 1].

The vibration of the tip becomes weak.

|

The tip hasn’t been screwed on to the handpiece tightly.

| Screw the tip on the handpiece tightly (See Picture 4).
The tip is loose because of

vibration.

| Screw on the tip tightly

(See Picture 4).

The coupling between the handpiece and the cable isn’t

dry.

|

Dry it by the hot air.

The tip is damaged [note 2].| Change a new one.
There is water seeping from the coupling between the handpiece

and cable.

|

The waterproof “O”ring is damaged.

|

Change a new waterproof “O”ring.

There is water flow out when turn off the power.| There is impurity in the solenoid valve.| Contact with the local distributor or manufacturer.
Fault| Possible cause| Solutions
---|---|---

The handpiece generates heat.

| The amount of spouting water is too little.| Turn the water control

switch to a higher grade [note 1].

The potentiometer is broken.| Change a new one.

The amount of spouting water is too little.

| The water control knob is a

low grade.

| Turn the knob to a high

grade [note 1].

The water pressure is not

enough.

| Enhance the water

pressure.

The water pipe is jammed.

| Clean water pipe with multi-function syringe [note2].
The vibrating intensity control knob is seized

up.

| The potentiometer is damaged.| Contact with the local distributor or our

company.

The u-file doesn’t

vibrate.

|

The screw is loose.

|

Tighten it.

Endochuck is damaged.| Change a new one.
There is noise coming

from the endochuck.

| The screw is loose.| Tighten it.

LED light don’t work

| Poor contact| Contact tightly
Something wrong with LED

light

| Change a new one
There is no water coming out from the handpiece (automatic water supply mode).|

There is air in the water pipe.

| Turn the water control to the Max, reinsert the bottle.

If the problem still can’t be solved, please contact with local dealer or manufacturer.
Notice
[Note 1] The water control knob can adjust the water volume according to the symbol.
[Note 2] To clean the water pipe with the multi-function syringe of the dental unit ( see picture 5):

• Snip the water pipe at a distance of 10cm to 20cm from the water entrance.
• Turn on the power switch, get through to the power.
• Connect the multi-function syringe of the dental unit to the water pipe.
• Screw off the scaling tip or pull out the handpiece.
• Step on the foot switch.
• Turn on the switch of the multi-function syringe, press the air or water into the water pipe to clean and eliminate the impurity.

[Note 3 ] If the scaling tip has been screwed on tightly and there is fine spray too, the following phenomena show that the scaling tip is damaged:

• The vibrating intensity and the pulverization degree become weak obviously.
• During operating, there is some buzz when the scaling tip is working.

Cleaning, Disinfection and Sterilization

The cleaning, disinfection and sterilization of handpiece, tip, and wrench (include torque wrench and Endo wrench) are as follow. Unless otherwise stated, they will be hereinafter referred to as “products”.
Warnings

• The use of strong detergent and disinfectant (alkaline pH>9 or acid pH <5) will reduce the life span of products. And in such cases, the manufacturer takes no responsibility.
• Do not clean the handpiece with ultrasound cleaning machine. This device shall not be exposed to high temperature above 138℃.

Processing limit
The products have been designed for a large number of sterilization cycles. The materials used in manufacture were selected accordingly.
However with every renewed preparation for use, thermal and chemical stresses will result in ageing of the products. The maximum number of sterilizations for handpiece is 600 times. For tips, it is 300 times. And for wrench, it is 1000 times.

Initial processing
Processing principles
It is only possible to carry out effective sterilization after the completion of effective cleaning and disinfection. Please ensure that, as part of your responsibility for the sterility of products during use, only sufficiently validated equipment and product-specific 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

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:

1. Let the Ultrasonic scaler works for 20-30 seconds under irrigation mode to flush the handpiece and tip;
2. Remove the handpiece from the Ultrasonic scaler, and rinse away the dirt on the surface of product with pure water (or distilled water/deionized water);
3. Dry the product with a clean, soft cloth and place it in a clean tray.

Notes
The water used here must be pure water, distilled water or deionized water.

Preparation before cleaning
Steps
Tools: Torque wrench, tray, soft brush, clean and dry soft cloth.

1. Remove the tip from product with torque wrench provided by Guilin Woodpecker Medical Instrument Co., Ltd, and then put the tip and wrench into a clean tray.
2. Unscrew the nipple of product counterclockwise, remove the sealing ring, light pipe (if any), and LED lamp(if any), and put them in the tray.
3. Use a clean soft brush to carefully brush the joints between product and the connector of cable, front thread, horn, nipple, seal ring, light pipe (if any) and LED lamp(if any) until the dirt on surface is not visible. Then use soft cloth to dry the product and accessories and put them into a clean tray. The cleaning agent can be pure water, distilled water or deionized water.

Cleaning
The cleaning should be performed no later than 24 hours after the operation. The cleaning can be divided into automated cleaning and manual cleaning. Automated cleaning is preferred if conditions permit.

Automated cleaning

• The cleaner is proved to be valid by CE certification in accordance with EN ISO 15883.
• There should be a flushing connector connected to the inner cavity of the product.
• The cleaning procedure is suitable for the product, and the irrigating period is sufficient.
• Do not clean the handpiece with ultrasound.
• 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 next section “Disinfection”.

Notes

• The cleaning agent does not have to be pure water. It can be distilled water, deionized water or multi enzyme. But please ensure that the selected cleaning agent is compatible with the product.
• In washing stage, the water temperature should not exceed 45 °C, otherwise the protein will solidify and it would be difficult to remove.
• After cleaning, the chemical residue should be less than 10mg / L.

Disinfection
Disinfection must be performed no later than 2 hours after the cleaning phase. Automated disinfection is preferred if conditions permit.

Automated disinfection-Washer-disinfector

• The washer-disinfector is proved to be valid by CE certification in accordance with EN ISO 15883.
• Use high temperature disinfection function. The temperature does not exceed 134 ° C, and the disinfection under the temperature cannot exceed 20 minutes.
• The disinfection cycle is in accordance with the disinfection cycle in EN ISO 15883.

Cleaning and disinfecting steps by using Washer-disinfector

1. Carefully place the product into the disinfection basket. Fixation of  product is needed only when the product is removable in the device. The products are not allowed to contact each other.
2. Use a suitable rinsing adaptor, and connect the internal water lines to the rinsing connection of the washer-disinfector.
3. Start the program.
4. After the program is finished, remove the product from the washer disinfector, inspect (refer to section “Inspection and Maintenance”) and packaging (refer to chapter “Packaging”). Dry the product repeatedly if necessary (refer to section “Drying”).

Notes

• Before use, you must carefully read the operating instructions provided by the equipment manufacturer to familiarize yourself with the disinfection process and precautions.
• With this equipment, cleaning, disinfection and drying will be carried out together.
• Cleaning: (c1) The cleaning procedure should be suitable for the product to be treated. The flushing period should be sufficient (5-10 minutes). Pre-wash for 3 minutes, wash for another 5 minutes, and rinse it for twice with each rinse lasting for 1 minute. (c2) In the washing stage, the water temperature should not exceed 45 °C, otherwise the protein will solidify and it is difficult to remove. (c3) The solution used can be pure water, distilled water, deionized water or multi-enzyme solution, etc., and only freshly prepared solutions can be used. (c4) During the use of cleaner, the concentration and time provided by manufacturer shall be obeyed. The used cleaner is neodisher MediZym (Dr. Weigert).
• Disinfection: (d1) Direct use after disinfection: temperature ≥ 90 ° C, time ≥ 5 min or A0 ≥ 3000. (d2)Sterilize it after disinfection and use: temperature ≥ 90 ° C, time ≥ 1 min or A0 ≥ 600. (d3) For the disinfection here, the temperature is 93 ° C, the time is 2.5 min, and A0>3000.
• 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).
• After cleaning, the chemical residue should be less than 10mg / L.
• The air used for drying must be filtered by HEPA.
• Regularly repair and inspect the disinfector.

Inspection and maintenance
In this chapter, we only check the appearance of the product. After inspection, if there is no problem, the handpiece should be immediately reassembled, installing the sealing ring, LED, light guide, and cone head in sequence to the handpiece, and then tighten the cone head clockwise.

• Check the product. If there is still visible stain on the product after cleaning/disinfection, the entire cleaning/disinfection process must be repeated.
• Check the product. If it is obviously damaged, smashed, detached, corroded or bent, it must be scrapped and not allowed to continue to be used.
• Check the product. If the accessories are found to be damaged, please replace it before use. And the new accessories for replacement must be cleaned, disinfected and dried.
• If the service time (number of times) of the product reaches the specified service life (number of times), please replace it in time.

Storage

1. Store in a clean, dry, ventilated, non-corrosive atmosphere with a relative humidity of 10% to 93%, an atmospheric pressure of 70KPa to 106KPa, and a temperature of -20 °C to +55 °C;
2. After sterilization, the product should be packaged in a medical sterilization bag or a clean sealing container, and stored in a special storage cabinet. The storage time should not exceed 7 days. If it is exceeded, it should be reprocessed before use.

Transportation

1. Prevent excessive shock and vibration during transportation, and handle with care;
2. It should not be mixed with dangerous goods during transportation.
3. Avoid exposure to sun or rain or snow during transportation.

The cleaning and disinfection of main unit are as follows.

• Before each use, wipe the surface of the connector of cable and cable with a soft cloth or paper towel soaked in 75% medical alcohol. Repeat the wipe for at least 3 times.
• Before each use, please let the Ultrasonic scaler work under irrigation mode for 20-30s, then install the handpiece.
• After each use, please let the Ultrasonic scaler work under irrigation mode for 20-30s, then remove the handpiece.
• After each use, wipe the surface of the connector of cable and cable with a soft cloth soaked in clean water (distilled or deionized water) or a clean disposable wipe. Repeat the wipe for at least 3 times.

Precaution

usage notice

• Keep the scaler clean before and after operation.
• The scaling tip, wrench and handpiece must be sterilized before each treatment.
• Don’t screw the scaling tip when stepping on the foot switch.
• The scaling tip must be fastened. There must be fine spray coming out from the tip when operating.
• Change a new one when the tip is damaged or worn excessively.
• Don’t twist or rub the tip.
• While scaler working, the heat of scaling tip will become higher if there is no water flowing out, please keep the water flow smoothly.
• Don’t use impure water source, and be sure not to use normal brine instead of pure water source.
• If use the water source without hydraulic pressure, the watersurface should be one meter higher than the head of the patient.
• Don’t knock or rub the handpiece.
• After each clinical operation with clinical liquid, change a bottle with purified water, turn the water supply to max, make the machine work with autowater supply for 30 seconds in order to keep the water way and spare parts clean and durable.
• Please put the power plug into the socket easy to pull out, to make sure it can be pull out in emergency.
• When using the equipment, please keep the water get through smoothly, otherwise patient’s tooth surface would be injured by overheat in the handpiece.
• After operating, turn off electrical source, and then pull out the plug.

Transportation

• Excessive impact and shake should be prevented in transportation. Lay it carefully and lightly and don’t invert it.
• Don’t put it together with dangerous goods during transportation.
• Avoid solarization and getting wet in rain or snow during transportation.

Working condition

• Environment temperature: +5°C to +40°C
• Relative humidity: 30%~75%
• Atmosphere pressure: 70kPa to 106kPa
• A temperature of the water at the inlet：not higher than +25°C

After service

We offer one year free repair to the equipment according to the warranty card. The repair of the equipment should be carried out by professional technician. We are not responsible for any irretrievable damage caused by the not professional person.

Symbol instruction

Environmental protection
Please dispose according to the local laws.

Manufacturer’s right

We reserve the rights to change the design of the equipment, the technique, fittings, the instruction manual and the content of the original packing list at any time without notice. If there are some differences between blueprint and real equipment, take the real equipment as the norm.

EMC – Declaration of conformity

The device has been tested and homologated in accordance with EN 60601-1-2 for EMC. This does not guarantee in any way that this device will not be effected by electromagnetic interference Avoid using the device in high electromagnetic environment.

Guidance and manufacturer’s declaration – electromagnetic emissions

The models D600, D600 LED are intended for use in the electromagnetic environment specified below. The customer or the user of the models D600, D600 LED should assure that it is used in such an environment.
Emissions test| Compliance| Electromagnetic environment – guidance

RF emissions CISPR 11

|

Group 1

| The models D600, D600 LED use RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR11| Class B|

The models D600, D600 LED are suitable for used in domestic establishment and in establishment directly connected to a low voltage power supply network which supplies buildings used for domestic purposes.

Harmonic emissions lEC 61000-3-2|

Class A

Voltage fluctuations

/  flicker emissions

lEC 61000-3-3

|

Complies

Guidance & Declaration — electromagnetic immunity

The models D600, D600 LED are intended for use in the electromagnetic environment specified below. The customer or the user of the models D600, D600 LED should assure that It is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
Electrostatic discharge (ESD)

lEC 61000-4-2

| ±8 kV contact

±2 kV, ±4 kV, ±8

kV, ±15 kV air

| ±8 kV contact ±2

kV, ±4 kV, ±8 kV,

±15 kV air

| Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the

relative humidity should be

at least 30 %.

Electrical fast transient/burst IEC 61000-4-4| ±2kV for power

supply lines

±1 kV for Input/

output lines

| ±2kV for power supply lines ±1kV for

interconnecting

cable

| Mains power quality should be that of a typical commercial or hospital environment.
---|---|---|---
Surge

lEC 61000-4-5

| ±1 kV line to line

±2 kV line to earth

| ±1 kV line to line| Mains power quality should be that of a typical commercial or hospital environment.
Voltage  dips, short interruptions and voltage variations on

power supply input lines IEC 61000-4-

| <5 % UT

(>95% dip in UT.) for 0.5 cycle

40 % UT

(60% dip in UT) for 5 cycles

70% UT

(30% dip in UT) for 25 cycles

<5% UT

(>95 % dip in UT) for 5 sec

| <5 % UT

(>95% dip in UT.)

for 0.5 cycle

40 % UT

(60% dip in UT) for 5 cycles

70% UT

(30% dip in UT) for 25 cycles

<5% UT

(>95 % dip in UT)

for 5 sec

| Mains power quality should be that of a typical commercial or hospital environment. If the user of the models D600, D600 LED require continued operation during power mains interruptions, it

is recommended that the models D600, D600

LED be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz)

magnetic field

lEC 61000-4-8

|

30A/m

|

30A/m

| Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE _U T _is the a.c. mains voltage prior to application of the test level.
Guidance & Declaration – Electromagnetic immunity

The models D600, D600 LED are intended for use in the electromagnetic environment specified below. The customer or the user of the models D600, D600 LED should assure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment

– guidance

Conducted RF lEC 61000-4-6

Radiat ed RF lEC 61000-4-3

|

3 Vrms

150 kHz to 80 MHz

3 V/m

80 MHz to 2.5 GHz

|

3 Vrms

3 V/m

| Port able and mobile RF communications equipment should be used no closer to any part of the models D600, D600 LED, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d=[3,5/V1]×P1/2

d=1.2×P1/2 80 MHz to 800 MHz

d=2.3×P1/2 800 MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter In watts (W) according to the transmitter manufacturer and d Is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b

Interference may occur In the vicinity of equipment marked with the following symbol:

---|---|---|---
NOTE I At 80 MHz end 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 and people.

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 to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the models D600, D600 LED are used exceeds the applicable RF compliance level above, the model D600, D600 LED should be observed to verify normal operation. If abnormal performance   is observed, additional measures may be necessary, such as reorienting or relocating the models D600, D600 LED.

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 models D600, D600 LED

The models D600, D600 LED are intended for use in electromagnetic environment in which radiated RF disturbances is controlled. The  customer or the user of the models D600, D600 LED can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile  RF communications equipment (transmitters) and the models D600, D600 LED are recommended below, according to the maximum output power of the  communications equipment.
Rated maximum output power of transmitter

W

| Separation distance according to frequency of transmitter m
150kHz to 80MHz d=1.2×P1/2| 80MHz to 800MHz d=1.2×P1/2| 800MHz to 2,5GHz 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, the recommended separation distance d in meters (m) can be estimated using the equation 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 manufacturer.

NOTE I At 80 MHz and 800 MHz. the separation distance for 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 and people.

Statement
Woodpecker reserves the right to change the design of the equipment, the technique, fittings, instruction manual and the content of the original 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.

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