Content

1. Introduction ........................................................................................ 1

2. Identication data ..............................................................................4

3. Testing of the device ........................................................................... 5

4. Delivery ...............................................................................................5

5. List of material included in the supply ............................................5

6. Installation .......................................................................................... 7

7. Controls ............................................................................................10

8. Cleaning, Disinfection and Sterilization .......................................16

9. Regular maintenance ......................................................................22

10. Replacement of the fuses ..............................................................23

11. Disposal procedures and precautions ......................................... 23

12. Tips ................................................................................................. 24

13. Symbols ..........................................................................................24

14. Troubleshooting .............................................................................25

15. Technical data ................................................................................27

16. After service ................................................................................... 28

17. Environmental protection ........................................................... 28

18. Manufacturer’s right .................................................................... 28

19.Guarantee .......................................................................................28

20. Statement .......................................................................................30

21.Declaration of comformity-EMC ...................................................30

1. Introduction

1.1 Foreword

Before proceeding with the installation, use, maintenance or any other activities

on the equipment please read the manual carefully.

Important: To avoid causing personal injuries or damages to property, read all the

points concerning “safety requirement” contained in this manual with particular

attention.

Depending on the level of risk involved, safety requirements are classed under

the following indications:

Danger(always referred to personal injury)

Warning(referred to possible damage to property)

Not to position the device to make it dicult to operate the disconnection device.

In the presence of electromagnetic interference environment, the device may

be malfunctioning. Do not install Surgic smart near equipment that releases

magnetic waves.

Warning, all unauthorized device modication may cause danger, please do not

try!

Surgic smart requires special precautions for EMC and needs to be installed and

put into service according to the EMC environment.

Device with electromagnetic launcher will aect the normal operation of Surgic

smart , do not run both devices at the same time.

To avoid the risk of electric shock, this equipment must only be connected to a

supply mains with protective earth.

The purpose of this manual is to ensure that operators are aware of the safety

requirements, of the installation procedures and of the instructions for correct use

and maintenance of the apparatus.

The user is not authorized to tamper with the equipment under any circumstances.

If any problems are encountered, please contact a Woodpecker Service Centre.

Any attempts on the part of the user or any unauthorized personnel to tamper with

or alter the apparatus will invalidate the warranty and release the Manufacturers

from any liability in respect of any harm or damage to persons or property.

The information and illustration contained in this manual are up-dated to the date

of publication indicated on the last page.

WOODPECKER is committed to continuous up-dating of the products,

which may entail changes to components of the equipment. If there are any

discrepancies between the descriptions contained in this manual and your

equipment, please contact your dealer or the WOOKPECKER After-sale service

for explanations.

Using this manual for purposes other than those relating to the installation, use

and maintenance of the equipment is strictly prohibited.

1.2 Description of the Device

Thanks to its controlled three-dimensional ultrasound oscillations, the original

Surgic smart technique rings in a new age for osteotomy and osteoplasty in

Implantology, Periodontology, Endodontics and Orthodontic Surgery. Its main

features are:

Micrometric cutting: Maximum surgical precision and intra-operative sensibility;

Selective cutting: Maximum safety for the soft tissues;

Cavitation eect: Maximum intra-operative visibility (bloodless eld);

The equipment has an automatic tuning circuit that osets wear of the tips, thus

ensuring work in constant conditions of maximum eciency.

1.3 Intended Use

The Surgic smart is a piezoelectric device for bone surgery that enables

osteotomy and osteoplasty techniques to be applied to in almost any anatomical

situation. This equipment can be used in the following elds:

a) Oral surgery;

b) Orthopedic surgery;

c) Maxillofacial surgery;

d) Cosmetic surgery;

e) Neurosurgery;

f) Otolaryngology.

This equipment cannot function in places where there is an inflammable

atmosphere (anaesthetic mixture, oxygen, etc).

1.4 Safety requirements

Woodpecker will not accept any liability for direct or incidental personal injury

or damage to property in the following cases:

1.4.1 If the equipment is used for purposes other than that for which it is

intended;

1.4.2 If the equipment is not used in accordance with all the instructions and

requirements described in this manual;

1.4.3 If the wiring system in the room where the equipment is used does not

comply with the application standard and appropriate requirements;

1.4.4 If any assembly operations, extensions, settings, alterations or repairs have

been carried out by personnel not authorized by Woodpecker;

1.4.5 If the environmental conditions in which the device is kept and stored

do not comply with the requirements indicated in the chapter on technical

specications.

Danger: Qualied and specialized personnel.

This equipment may be used only by specialized and suitably trained personnel

such as surgeons. If correctly used, this equipment does not give rise to side

eects. Improper use, on the other hand, will give rise to transmission of heat to

the tissues.

Danger: Intended use.

Use the equipment solely for the purpose for which it is intended (see point 1.3),

failure to comply with this requirement could lead to serious harm to the patient

and/or to the operator and/or damage to/failure of the equipment.

Danger: Contraindications.

Do not use the Surgic smart on patients with pace-makers or other implantable

electronic devices. The same requirement applies also to the operator.

Danger: Contraindications.

An electrosurgical knife could interfere with correct functioning of the device.

Danger: Cleaning, disinfection and sterilization of new or repaired

products.

All new or repaired products are delivered in no sterile conditions. Before being

used for treatments, all new or repaired products should be cleaned, disinfected

and sterilization following the instructions provided under point 8 strictly.

Danger: Use only original Woodpecker accessories and spare parts.

Danger: Check the condition of the device before treatment.

Always make sure that there is no water under the apparatus. Before each

treatment always check that the equipment is in proper working order and that

the accessories are ecient. Do not carry out the treatment if any problems are

encountered in operating the device. If the problems concern the equipment

contact an authorized technical service centre.

Danger: Breakage and wear of the tips.

The high-frequency vibrations and wear may, very occasionally, lead to breakage

of the tip. Tips of which the shape has been changed or which are otherwise

damaged are liable to break during use. Any such tips should denitely not be

used. It is necessary to instruct the patient to breathe though his nose during the

treatment in order to avoid ingestion of the broken o fragment of the tip.

Danger: Do not install this equipment anywhere there is a risk of

explosions.

This equipment cannot function in places where there is an inflammable

atmosphere. (anaesthetic mixture, oxygen, etc)

Danger: Personnel injury.

The foot pedal of the Surgic smart must not be activated when the door of the

peristaltic pump open. (Fig.5—Ref.B).Moving parts could injure the operator.

Danger: Contraindication.

Do not carry out this treatment on metal or ceramic prosthetic artifacts. The

ultrasonic vibrations could lead to decrementing of such artifacts.

Danger: Contraindication.

After autoclave sterilizing of the handpiece, wait for it to cool down completely

before using item.

2. Identication data

2.1 Identication data

An exact description of the model including the serial number of the equipment

will make it easier for our After-Sale Service to respond quickly and eciently to

your enquiry.

Always provide the above information whenever you contact a Woodpecker

Service Centre.

2.2 Data plate of the device

Each device has its own data plate (Fig.1), on which technical specifications

and serial number are indicated. The data plate is on the rear of the device. The

remaining data are included in this manual (see point 15).

Fig.1

2.3 Data plate of the scaler handpiece

The serial number of the Surgic smart handpiece is engraved on the ring nut

(Fig.2).

Fig.2

3. Testing of the device

All the devices are checked and tested by Woodpecker completely, including all

the parts.

When testing, all the parts will work in intermittent operation.

The test emphasized that all the problems are from the failure parts. This

procedure ensures the function and reliability of all the parts.

4. Delivery

Avoid the excessive concussion, shake, cover in delivery.

Do not mix with the danger articles.

Avoid the sunlight, rain and snow in delivery.

5. List of material included in the supply

The material included in the supply may vary in case of promotional campaigns.

Warning: Handpiece and cord can’t be detached.

Name Quality Ref

Device 1 Fig.4—Ref.A

Multi-function foot pedal 1 Fig.4—Ref.B

Brine bottle connector 2 Fig.4—Ref.C*

Hook 1 Fig.4—Ref.D

Pump tube 8 Fig.4—Ref.E*

Peristaltic pump 1 Fig.4—Ref.F

Surgic smart handpiece 2 Fig.4—Ref.G*

Name Quality Ref

Silicone handpiece holder 2 Fig.4—Ref.H*

Connection for the cord and

tube of the peristaltic pump

4 Fig.4—Ref.J*

Torque wrench 1 Fig.4—Ref.K*

Sterilize box 2 Fig.4—Ref.L*

Tip Holder and Tips

Marked on the

packing list

Fig.4—Ref.M*

Power-supply cable 1 Fig.4—Ref.N

Fig.4

6. Installation

6.1 Safety requirements during Installation

Danger: The wiring system of the premises where the apparatus

is installed and used must comply with the applicable standards and the

relevant electrical safety requirements.

Danger: Do not install the apparatus in places where there is a risk

of explosion. The apparatus may not be used in areas where there are

inammable atmospheres (anaesthetic mixtures, oxygen, etc).

Danger: Install the apparatus in a place where it will be protected from

blows and from accidental sprays of water or other liquids.

Danger: Do not install the device on or in the vicinity of sources of

heat. Install it such a way that there is an adequate circulation of air around

it. Leave sucient free space around it, in particular with reference to the

fan on the rear. (Fig.6)

Warning: Do not expose the apparatus to direct sunlight or to sources of

UV light.

Warning: The apparatus is transportable, however it must be handled

with care when it is moved.

Warning: Before connecting the cord to the device, make sure that

the electrical contacts are perfectly dry. If necessary, dry them with the air

syringe.

Warning: To avoid risk of electric shock, this equipment must only be

connected to a supply mains with protective earth.

Warning: The capacity of brine bottle hang on brine bottle holder

should not be more than 1000ml, and the weight should not exceed 1Kg.

6.2 Initial installation

To ensure perfect operation of the equipment, it is installed by technical

personnel authorized by Woodpecker. The equipment will be installed in a

suitable and handy place for it to be used.

The technician must:

6.2.1 Install the device in a suitable place;

6.2.2 Explain the main aspects of correct installation to the user;

6.2.3 Fill in the installation form, including the purchaser’s data;

6.2.4 Send the installation form to Woodpecker to ensure traceability and

activation of the warranty.

Fig.5

6.3 Connection the accessories

The accessories listed as follow should be connected with the Surgic smart :

6.3.1 Insert the silicone tube into the peristaltic pump, proceeding as follows:

a) Open the door(Fig.5—Ref.A)as far as it will go.

b) Position the tube in the impeller(Fig.5—Ref.B,C).

c) Close the door completely(Fig.5—Ref.D).

Danger: personnel injury.

The foot pedal of the Surgic smart must not be activated when the door of the

peristaltic pump open. (Fig.5—Ref.A).Moving parts could injure the operator.

6.3.2 Insert the rod for supporting the bag into the holes provided for it (Fig.6—

Ref.A);

6.3.3 Connect the foot pedal to the casting of the device by inserting the plug into

the foot pedal socket (Fig.6—Ref.E);

6.3.4 Plug the power cable into the connector on the casting of the device (Fig.6—

Ref.D) and then into the power outlet;

6.3.5 Insert the tube of Surgic smart cord to the cord connector on the device

(Fig.6—Ref.B);

6.3.6 Connect end of the tube of the peristaltic pump;

6.3.7 Connect the flow-control system to the bag containing the appropriate

liquid for the treatment;

6.3.8 Use the torque wrench to screw the tip (Fig.7) till the clattering voice;

6.3.9 Press the button “on/o” (Fig.6—Ref.C), then can use the device.

Fig.6

Fig.7

Fig.8

7. Controls

7.1 Description of the controls

This section illustrates the parts of the front panel of the Surgic smart unit,

enabling the controls described in this manual to be located immediately.

7.1.1 Description of bone function:

Fig. 9

As shown in Fig. 9, when the mode name "Bone " is selected in the green frame,

the device is in bone cutting mode;In this mode, there are "power" and "water

volume" that can be adjusted by sliding;Among them, the “power” in the 1~10

levels respectively correspond to the bone density pictures “D4~D1” on the left.

In this interface, there is also the "H/S" key to switch the bone cutting depth:

Surface cortical bone and deep cancellous bone;There is an "enhance" button,

which can increase the current power by 30% with one button, which is convenient

for eciency improvement;There is a "light" button, which can switch the LED

light on the handle;There is a "Settings" button for system settings and function

introduction.

7.1.2 Description of perio function:

Fig.10

As shown in Fig. 10, when the mode name " perio " is selected in the green

frame, the device is in periodontal mode; in this mode, the function buttons are in

the same bone cutting mode

7.1.3 Description of Endo function:

Fig.11

As shown in Fig. 11, when the mode name "Endo" is selected in the green frame,

the device is in theEndo mode; in this mode, the function buttons are the same as

the bone mode.

7.1.4 Description of clean function:

Fig.12

7.1.5 Description of Flush function:

Fig.13

As shown in Figures 12 and 13, when the mode name "Clean" is selected in the

green frame, the device is in the cleaning mode; in this mode, the device has only

the water output function and no ultrasonic vibration is output; it is divided into

the "cleaning mode" "And "Flush Mode". "Clean mode" shown in Figure 12,

is used to ush the pipeline with clean water after the operation; "Flush mode"

shown in Figure 13, can adjust the output of quantitative water each time you

step on the pedal.

7.2 Description of the display and functions

There are three functions of bone root, clean for this Surgic smart .

7.2.1 BONE function (Fig.8)

In bone function, both the water and power model are available.Ten power levels

as follows:

a) Power 9-10: D1,Very high bone density

b) Power 6-8: D2,High bone density

c) Power 3-5: D3,Middle bone density

d) Power 1-2: D4,Low bone density

7.2.2 PERIO function (Fig.9)

In this function, both the water and power model are available, one model as

follow:Perio.

7.2.3 ENDO function (Fig.10)

In this function, both the water and power model are available, one model as

follow:Endo.

7.2.4 CLEAN function (Fig.11)

In this function, press the foot pedal, the device can clean the tube .(Recommed

at least 25 seconds)

7.2.5 FLUSH function (Fig.12)

In this function, Step on the foot pedal once, out of a certain amount of water,

water adjustable: The range is 0.5 ~ 5 ml/time .

7.3 Safety requirements during use.

Danger: Contraindications.

Do not use the Surgic smart on patients with pacemakers or other implantable

electronic devices. This requirement also applies to the operator.

Danger: Breakage and wear of the tips.

The high-frequency vibrations and wear may, very occasionally, lead to breakage

of the tip. Tips of which the shape has been changed or which are otherwise

damaged are liable to break during use. Any such tips should denitely not be

used. It is necessary to instruct the patient to breathe through his nose during the

treatment in order to avoid ingestion of the broken fragment of the tip.

Danger: Control of infections.

For maximum safety of both the patient and the operator, clean, disinfect and

sterilize the piezo electronic handpiece, the tips and the torque wrench after each

treatment.

Warning: Contraindication.

Do not carry out this treatment on metal or ceramic prosthetic artifacts. The

ultrasonic vibrations could lead to decrementing of such artifacts.

Warning: Contraindication.

After autoclave sterilizing of the handpiece, wait for it to cool down completely

before using it.

Warning: The electrical contacts inside the cord connector must be dry.

Before connecting the handpiece to the device, make sure the electrical contacts

of the connector are perfectly dry, in particular after the autoclave sterilization

cycle. If necessary, dry the contacts by blowing air onto them with the syringe.

Warning: To use the device correctly, it is necessary to press the foot

pedal and start it up without letting the tip rest on the part to be treated.

This will allow the electronic circuit to detect the point where resonance of

the tip is without any interference, thus enabling optimum performance.

If this is not done, contact with the part to be treated or with other surfaces before

start-up could cause tripping of the protection systems.

Warning: For spray treatment, use only tips through which liquid is

passed.

7.4 Protection systems and alarms.

The device has a diagnostics circuit that is used to recognize tripping of the

protection system and of the alarms. These are shown on the display, as follows:

Warning code Warning description Solution

Warn 01

The handle is not

completely dry or

reduced in performance

Please ensure that the handle is

completely dry. If the alarm is not

removed, replace the handle.

Warn 02

There is no reliable

connection in the handle

Please reconnect the handle interface

Warn 03 Fan failure

Please call the Woodpecker service

centre immediately.

Warn 04 Pump failure

Please call the Woodpecker service

centre immediately.

Warn 05 Abnormal power failure

Please call the Woodpecker service

centre immediately.

Warn 06

Abnormal handle or

work tip loosening

Please reconnect the handle and

tighten the working tips. If the alarm

is not eliminated, please contact the

local sales or woodpecker company.

Warn 07

Abnormality of bone

cutting pattern

Please restart the device, if the

problem persists, stop using it and

call the Woodpecker service centre

immediately.

7.5 Instruction for use

7.5.1 Open the air intake on the drip system;

7.5.2 Screw the chosen tip onto the Surgic smart handpiece until it is flush

against it;

7.5.3 To use the torque wrench correctly (Fig.7) proceed as follow;

a) Hold the body of the handpiece rmly;

Warning: Do not grip the end part of the handpiece or the cord, only the

plastic casting (Fig.7) and do not turn it while fastening the tip in place;

b) Turn the wrench in a clockwise direction until the cultch engages (till making

clicking sound);

c) The tip is now properly tightened in place;

7.5.4 Make sure that the Surgic smart handpiece is correctly connected to the

handpiece connector (Fig.6-Ref.B);

7.5.5 Check the display to see the type of power that has been set. If the type of

power required dierent from the type that has been set, use key “M” on Multi-

founction foot pedal to switch;

7.5.6 Check the display to see the power level that has been set, if the type of

power required diers from the level that has been set, use the key “P”on Multi-

founction foot pedal for selecting, depending on the type of function that has

been set;

7.5.7 Check the display to see the delivery rate of the peristaltic pump, if

the delivery rate required is other than the level that has been set, use the key

“Water”on Multi-founction foot pedal to choose, depending on the type of

function that has been set.

7.6 Rules for keeping the device in proper working order

7.6.1 Check the state of wear of the tips periodically and replace any for which a

drop in performance is noted;

7.6.2 Do not alter the shape of the tips by bending or lling them;

7.6.3 Replace any tip that has become deformed or damaged by impacts;

7.6.4 Always make sure that any threaded parts and their contact surfaces are

perfectly clean;

7.6.5 If an tip becomes too worn, the device will stop working.

7.7 Settings permitted according to insert type

The following table shows the Mode and Power settings permitted for correct use

of the device.

Insert Mode Power

SS1-SS2-SS3-SS4-SS5-SS6-

SS1L-SS1R

BONE Power1-Power10

SL1-SL2-SL3-SL4-SL5 BONE Power1-Power10

SC1 BONE Power1-Power10

SI1-SI2-SI7-SI8-SI9 BONE Power1-Power10

SP1-SP2-SP3-SP4-SP5-SP6-

SP7

Perio Power1-Power10

SE1-SE2-SE3-SE4 Endo Power1-Power10

7.8 When the equipment is nished, turn o the power switch, press the

button “o” (Fig.6—Ref.C), then remove the power plug.

8. Cleaning, Disinfection and Sterilization

The cleaning, disinfection and sterilization of :

1. Handpiece,

2. Torque wrench,

3. Pump tube,

4. Brine bottle connector,

5. Connection for the cord and tube of the peristaltic pump,

6. Tips,

7. Tip holder,

8. Silica gel support for the handpiece,

9. Sterilize box.

Unless otherwise stated, they will be hereinafter referred to as “products”.

Warning:

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.

The products 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 recommended sterilization times for pump tube is 8 times; the

maximum allowable sterilization times for handpiece and Silica gel support for

the handpiece is 100 times; the maximum allowable sterilization times for tip

is 300 times; the maximum allowable sterilization times for connection for the

cord and tube of the peristaltic pump, brine bottle connector, torque wrench and

Sterilize box is 300 times.

8.1 Initial processing

8.1.1 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 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 requirements for the inactivation of prions.

8.1.2 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:

1.Ultrasonic bone surgery is operated in ushing mode for 20-30 seconds to ush

the handpiece and tip;

2.Remove the handpiece from the Ultrasonic bone surgery, and rinse away the

dirt on the surface of the products with pure water (or distilled water/deionized

water);

Note:

1) The package used conforms to ISO 11607;

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 of contaminants;

4) Avoid contact with parts of dierent metals when packaging.

8.2 Preparation before cleaning

Tools: Ultrasonic bone surgery torque wrench, tray, soft brush, clean and dry soft

cloth

1. Adjust the machine to the cleaning mode, step on the pedal for 3s to start the

cleaning procedure;

Note:

1. Pure water, distilled water or deionized water should be used at this time.

2. Screw the handpiece interface sealing sleeve of the machine into the interface

to ensure that the interface is not eroded by water;

3. Remove the tip from product with Ultrasonic bone surgery torque wrench

provided by Guilin Woodpecker Medical Instrument Co., Ltd, and then put the

tip and torque wrench into a clean tray.

4. Unscrew the nipple at the front end of the handpiece in a counterclockwise

direction, remove the light pipe and LED lamp, and put them into the tray.

5. Use a clean soft brush to carefully brush the front thread, horn, nipple, light

pipe and LED lamp until the dirt on surface is not visible. Then use soft cloth to

dry the handpiece and accessories and put them into a clean tray. The cleaning

agent can be pure water, distilled water or deionized water.

Disassembling steps

8.3 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.

8.3.1 Automated cleaning

• The cleaner is proved to be valid by CE certicationin 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 products, and the ushing period is

sucient.

• Do not clean the handpiece with ultrasound.

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 next section «Disinfection».

Note:

a) 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 products.

b) In washing stage, the water temperature should not exceed 45 °C, otherwise

the protein will solidify and it would be dicult to remove.

c) After cleaning, the chemical residue should be less than 10mg / L.

8.4 Disinfection

Disinfection must be performed no later than 2 hours after the cleaning phase.

Automated disinfection is preferred if conditions permit.

8.4.1 Automated disinfection-Washer-disinfector

• The washer-disinfector is proved to be valid by CE certication 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 products into the disinfection basket. Fixation of products

is needed only when the product is removable in the device. The products are not

allowed to contact each other.

2. Connect the inner cavity of the product to the flushing connection of the

washer-disinfector with a proper cleaning connector.

3. Start the program.

4. After the program is nished, remove the products from the washer-disinfector,

inspect (refer to section «Inspection and Maintenance») and packaging (refer to

chapter «Packaging»). Dry the products repeatedly if necessary (refer to section

«Drying»).

Note:

1) Before use, you must carefully read the operating instructions provided by the

equipment manufacturer to familiarize yourself with the disinfection process and

precautions.

2) With this equipment, cleaning, disinfection and drying will be carried out

together.

3) Cleaning: (a) The cleaning procedure should be suitable for the products to be

treated. The ushing period should be sucient (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. (b) In the washing stage, the water temperature should not exceed

45 °C, otherwise the protein will solidify and it is dicult to remove. (c) The

solution used can be pure water, distilled water, deionized water or multi-enzyme

solution, etc., and only freshly prepared solutions can be used. (d)During the use

of cleaner, the concentration and time provided by manufacturer shall be obeyed.

The used cleaner is neodisher MediZym (Dr. Weigert).

4) Disinfection: (a) Direct use after disinfection: temperature ≥ 90 ° C, time ≥ 5

min or A0 ≥ 3000;

Sterilize it after disinfection and use: temperature ≥ 90 ° C, time ≥ 1 min or A0 ≥

600

(b) The disinfection temperature used here is 93 ℃, the time is 2.5 min, and

A0>3000

5) 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).

6) After cleaning, the chemical residue should be less than 10mg / L.

7) The air used for drying must be ltered by HEPA.

8) Regularly repair and inspect the disinfector.

8.5 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 products

against the white paper (white cloth), and then dry the products with ltered dry

compressed air (maximum pressure 3 bar). Until no liquid is sprayed onto the

white paper (white cloth), the products drying is completed.

2. It can also 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.

Note:

1)The drying of product must be performed in a clean place.

2)The drying temperature should not exceed 138 °C;

3)The equipment used should be inspected and maintained regularly.

8.6 Inspection and maintenance

In this chapter, we only check the appearance of the products. After inspection, if

there is no problem, the handpiece should be immediately reassembled, installing

the LED, light guide, and cone head in sequence to the handpiece, and then

tighten the cone head clockwise.

1. Check the products. If there is still visible stain on the products after cleaning/

disinfection, the entire cleaning/disinfection process must be repeated.

2. Check the products. 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 products. 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.

4. If the service time (number of times) of the products reaches the specified

service life (number of times), please replace it in time.

8.7 Packaging

Install the disinfected and dried products and quickly package it in a medical

sterilization bag (or special holder, sterile box).

Note:

1) The package used conforms to ISO 11607;

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 of contaminants;

4) Avoid contact with parts of dierent metals when packaging.

8.8 Sterilization

Use only the following steam sterilization procedures (fractional pre-vacuum

procedure*) for sterilization, and other sterilization procedures are prohibited:

1.The steam sterilizer complies with EN13060 or is certied according to EN 285

to comply with EN ISO 17665;

2. The highest sterilization temperature is 138 ° C;

3. 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.

4. Allow a maximum sterilization time of 20 minutes at 134 °C.

Verication of the fundamental suitability of the products for eective steam

sterilization was provided by a veried testing laboratory.

Note:

1) Only products that have been eectively cleaned and disinfected are allowed

to be sterilized;

2) Before using the sterilizer for sterilization, read the Instruction Manual

provided by the equipment manufacturer and follow the instructions.

3) Do not use hot air sterilization and radiation sterilization as this may result in

damage to the product;

4) Please use the recommended sterilization procedures for sterilization. It is not

recommended to sterilize with other sterilization procedures such as ethylene

oxide, formaldehyde and low temperature plasma sterilization. The manufacturer

assumes no responsibility for the procedures that have not been recommended.

If you use the sterilization procedures that have not been recommended, please

adhere to related eective standards and verify the suitability and eectiveness.

Fractional pre-vacuum procedure = steam sterilization with repetitive pre-

vacuum. The procedure used here is to perform steam sterilization through three

pre-vacuums.

8.9 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.

Note:

1)The storage environment should be clean and must be disinfected regularly;

2)Product storage must be batched and marked and recorded.

8.10 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.

3. The cleaning and disinfection of main unit are as follows:

• Before each use, wipe the surface of the machine and the tail cord of the

handpiece with a soft cloth or paper towel soaked in 75% medical alcohol.

Repeat the wiping for at least 3 times.

• Before each use, please let the Ultrasonic Periodontal Treatment Device work

under irrigation mode for 20-30s, and then install the handpiece.

• After each use, please let the Ultrasonic Periodontal Treatment Device work

under irrigation mode for 20-30s, and then remove the handpiece.

• After each use, wipe the surface of the device and the tail cord of the handpiece

with a soft cloth soaked in clean water (distilled or deionized water) or a clean

disposable wipe. Repeat the wiping for at least 3 times.

9. Regular maintenance

9.1 Handle this device gently, keep away from the shake source, and should

install and store in shade.

9.2 Do not mix with poison, causticity, explosive and combustible things

together.

9.3 This equipment should be stored in a room where the relative humidity is

10% ~ 93%, atmospheric pressure is 70kPa to106kPa, and the temperature is

-20℃ ~ +55℃.

9.4 If the device is not used for a long time running, it is better to connect the

electricity and water one time per month, 5 minutes per time.

9.5 Disconnect the device from the power mains.

Danger: Check regularly that the power cable is intact, if it is

damaged, replace it with an Woodpecker spare.

10. Replacement of the fuses

Danger: Switch o the apparatus.

Always turn off the apparatus by means of the switch (Fig.5-Ref.B) and

disconnect it from the power outlet before carrying out the following maintenance

activities.

10.1 Insert the at tip of a screwdriver into the recess in the fuse compartment

below the power socket and use it as a lever (Fig.12-Ref.A);

10.2 Pull out the fuse compartment(Fig.12-Ref.B);

10.3 Danger: Replace the fuses, using fuses of the type indicated on the

identication label on the bottom of the apparatus;

10.4 Put the compartment back into place (Fig.12-Ref.B).

Fig.12

11. Disposal procedures and precautions

Danger: Hospital waste

Treat the following items as hospital waste

- Tips, when worn or broken.

- Tube of the peristaltic pump, after 8 sterilizing cycles.

- Torque wrench for tightening tips, when worn or broken.

12. Tips

12.1 Sharp tips

The sharp edges of these tips can be used to treat bone structures eciently and

effectively. Sharp tips are used in osteotomy and osteoplasty when a fine and

well-dened cut in the bone structure concerned it required, there are also tips

with sharp edges for osteoplasty techniques and for removing bone fragments.

12.2 Smoothing tips

The smoothing tips have surfaces shaped in such a way that they can be used to

work the bone structures with precision and in a controlled manner. Smoothing

tips are used in osteotomy when it is necessary to prepare dicult and delicate

structures such as those for preparing a maxillary sinus window or to complete

preparation of the site of an implant.

12.3 Blunt tips

Blunt tips are used for separating the soft tissues, for example for detaching

schneider’s membrane or for lateralizing nerves. In periodontology, these tips are

used to smooth the root surfaces.

13. Symbols

Mark

Follow instructions for use Use indoor only

Alternating current

Socker for the foot

pedal

Manufacturer Drip-proof

Can be autoclaved Date of manufacture

Protective earthing

Caution mechanical

injury

1.6A, 250V Pwtective tube Type B applied part

Serial number CE marked product

Atmospheric pressure for

storage

Temperature

limitation for

storage

Humidity limitation for

storage

Appliance

compliance WEEE

directive

Strong water spraying

experiment

Input voltage

Authorised Representative in the EUROPEAN COMMUNITY

14. Troubleshooting

If the device does not seem to be working properly, read the instruction again and

then check the following table:

Problem Possible cause solution

The device does not turn

on when the switch it

positioned on ON.

The connector on the end of

the power cable is plugged

into the socket on the rear

of the device properly.

Check that the power

cable is rmly connected.

The power cable is faulty.

Check that the power

outlet is working

properly. Replace the

power cable.

The fuses blew out.

Replace the fuses.

The connector on the

end of the power cable is

plugged into the socket

on the rear of the device

properly.

The connector of the

foot pedal is not properly

plugged into the socket.

Insert the foot pedal

connector

properly.

The foot pedal will not

work.

Contact the nearest

dealer or authorized

Woodpecker service

centre.

A faint whistle can be

heard coming from

the Surgic Touch Pro

handpiece during

operation.

The tip is not correctly

tightened onto the

handpiece.

Unscrew the tip and

screw it back into place

correctly.

Problem Possible cause solution

The device is switched

on but does not work, the

message WARN appears

on the display.

The tip is not tted correctly

into the handpiece.

Unscrew the tip and

screw it back into place

correctly.

The tip is worn, broken or

deformed.

Replace the tip.

The connector of the cord

is wet.

Dry the connectors.

The device is switched

on but will not work, the

message WARN appears

on the display.

Cord not connected to the

device.

Connect the cord to the

device.

Lack of continuity of a lead

in the cord.

Contact the nearest

dealer or authorized

Woodpecker service

centre.

Handpiece failure.

Contact the nearest

dealer or authorized

Woodpecker service

centre.

Malfunctioning of the

tuning circuit.

Contact the nearest

dealer or authorized

Woodpecker service

centre.

No liquid comes out of

the tip during operation.

The tip is of the type with

no through-ow of liquid.

Use an tip of the type

with through-ow of

liquid.

The bag of liquid is empty.

Replace the bag with a

full one.

The cover of pump that

connected with the water

tube is open.

Close the cover.

The tubes of the drip system

and of the pump have not

been correctly installed.

Check the connections of

the tubes.

The tip is clogged.

Free the passage in the

tip through which the

water passes.

Problem Possible cause solution

No liquid comes out of

the tip during operation.

The handpiece is clogged.

Contact the nearest

dealer or authorized

Woodpecker service

centre.

The device is working

properly, but the pump is

being forced.

Too much pressure by the

impeller on the tube in the

peristaltic pump.

Check that the tube in

the peristaltic pump has

been correctly inserted.

The pump is running

correctly but when it

stops liquid comes out of

the handpiece.

The door of the peristaltic

pump is not closed

properly.

Make sure that the door

of the peristaltic pump is

properly closed.

Insucient power.

The tip is not correctly

tted to the handpiece (the

message WARN appears on

the display).

Unscrew the tip and

screw it back into place

correctly.

The tip is worn, broken

or deformed (the message

WARN appears on the

display).

Replace the tip.

LCD screen mess or

imcomplete display.

Voltage interference.

Stop any operation,

change the model then

return to the original

model or restart the

machine.

15. Technical data

15.1 Device in accordance with Directive 93/42EEC.

15.2 According to EN60529: IPX1 (device)

IPX6 (foot pedal)

15.3 Software version: BoneSurgical4-V1.0.0

15.4 Device for intermittent operation: 60s ON, 10s OFF

15.5 Power-supply voltage: ~100V-240V 50Hz/60Hz 170VA

15.6 Fuses: 2×1.6AT 250V

15.7 Working frequency: 24kHz~36kHz

15.8 Flow: 25~110ml/m

15.9Applied parts: Tips

15.10 Protection systems and tripping time of the APC:

No handpiece connected: 10ms

Cord interrupted: 10ms

Tips broken or not correctly tightened:

＜

500ms

Protection by discharge to earth: 10ms

15.11 Alarm: Front display show the e (see point 7.3 and 14)

15.12 Operation environment:

a) Environment temperatuer: +5°C~+40°C

b) Relative humidity: 30%~75%

c) Atmosphere pressure: 70kPa~106kPa

d) Temperature in the water inlet of water-cooling equipment is not higher than

25°C

15.13 Delivery and store environment: This equipment should be stored in a

room where the relative humidity is 10% ~ 93%, atmospheric pressure is 70kPa

to106kPa, and the temperature is -20℃ ~ +55℃.

15.14 Pump tube: less than 8 sterilization cycles is highly recommended

15.15 Size of main unit: 276 mm×267 mm×110mm

15.16 Weight of main unit: 2.8kg

15.17 Type of protection against electric shock: Class Ⅰ equipment

15.18 Degree of protection against electric shock: Type B applied part

16. After service

We oer two year, free repair to the equipment according to the warranty card.

The repair of the equipment should be carried out by our professional technician.

We are not responsible for any irretrievable damage caused by the non-

professional person.

Woodpecker state that the we can provide circuit diagrams, component lists,

drawings, calibration details, or other information to help maintenance personnel

repair Surgic smart components that can be repaired by maintenance personnel

designated as required.

17. Environmental protection

Please dispose according to the local laws.

18. Manufacturer’s right

We reserve the right to change the design of the equipment, the technique,

ttings, 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.

19.Guarantee

19.1 Before being placed on the market, all WOODPECKER equipment

undergoes a thorough nal check to ensure that it is are in proper working order.

19.2 WOODPECKER guarantees its products, purchased new from a

WOODPECKER dealer or importer, to be free from manufacturing or material

defects for:

-TWO YEAR from the date of purchase for the device;

-ONE YEAR from the date of purchase for the handpiece with its cord.

19.3 Throughout the warranty period, WOODPECKER undertakes to repair (or,

at their sole discretion, to replace) free of charge any parts that, in their opinion,

are faulty.

Complete replacement of WOODPECKER products is excluded

19.4 Woodpecker cannot accept any liability for direct or incidental damage or

personal injury in the following cases:

19.4.1 If the equipment is used for purposes other than that for which it is

intended;

19.4.2 If the equipment is not used in accordance with all the instruction and

requirement described in this manual;

19.4.3 If the wiring system in the room where the equipment is used does not

comply with the applicable standards and appropriate requirements;

19.4.4 If any assemble operations, extensions, settings, alterations or repairs have

been carried out by personnel not authorized by Woodpecker;

19.4.5If the environmental conditions in which the device is kept and stored

do not comply with the requirements indicated in the chapter on technical

specications.

19.5 Accidental damages due to transport, incorrect use or carelessness or to

connection to power supplies other than as envisaged and damage to the signaling

lamps handpiece and all accessories are excluded from the warranty.

The warranty will no longer apply if the apparatus has been tampered with or

repaired by unauthorized personnel.

19.6 Warning:

The warranty is valid only if the warranty slip enclosed with the product has been

completed in full and returned to us or, if appropriate, to your WOODPECKER

dealer or importer within 20 days from the date of purchase, as proven by the

consignment note/invoice issued by the dealer/importer.

In order to benefit from the warranty service, the customer must return the

apparatus to be repaired to the WOODPECKER dealer/importer from which it

was purchased, at his own expense.

19.7 The apparatus should be returned suitable packed (possibly in its original

packing material).

19.8 Accompanied by all the accessories and by the following information:

19.8.1 Owner’s details, including his telephone number;

19.8.2 Details of the dealer/importer;

19.8.3 Photocopy of the consignment note/purchase invoice of the apparatus

issued to the owner and indicating, in addition to the date, also the name of the

apparatus and its serial number;

19.8.4 A description of the problem.

19.9 Transport and any damages caused during transport are not covered by the

warranty

In the event of failure due to accidents or improper use, or if the warranty has

lapsed, repairs to WOODPECKER produces will be charged on the basis of the

actual cost of the materials and labour required fro such repairs.

20. Statement

This is to certify that all the functions of the equipment have been tested rigidly.

All the functions run normally. In special condition, abnormal phenomenon may

happen due to the unavoidable interference.

In the equipment, power network or static interference may make the display

screen display white ake. This phenomenon does not inuence the operation of

normal functions. Solvents: Stop the equipment, press the top-right key-press on

the display panel to change the display of screen, then return. Thus the equipment

can display normally. Or turn o the power supply, restart the equipment.

All rights of modifying the product are reserved to the manufacturer without

further notice. The pictures are only for reference. The nal interpretation rights

belong to GSILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.

The industrial design, inner structure, etc, have claimed for several patents by

WOODPECKER, any copy or fake product must take legal responsibilities.

21.Declaration of comformity-EMC

Guidance and manufacturer’s declaration - electromagnetic emissions

The models Ai-surgrey, Surgic smart are intended for use in the electromagnetic

environment specied below. The customer or the user of the models Ai-surgrey,

Surgic smart should assure that they are used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions

CISPR 11

Group 1

The models Ai-surgrey, Surgic smart 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 Ai-surgrey, Surgic smart 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

uctuations

/ icker

emissions lEC

61000-3-3

Complies

Guidance & Declara tion — electromagnetic immunity

The models Ai-surgrey, Surgic smart are intended for use in the electromagnetic

environment specied below. The customer or the user of the models Ai-surgrey,

Surgic smart should assure that they are used in such an environment.

Immunity test

IEC 60601

test level

Compliance

level

Electromagnetic environment -

guidance

Electrostatic

discharge

(ESD)

IEC 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 oors are

covered with synthetic material,

the relative humidity should be at

least 30 %.

Electrical fast

transienUburst

IEC 61000-4-4

2kV

for power

supply lines

1 kV

for Input/

output lines

2kV for

power supply

lines

Mains power quality should be

that of a typical commercial or

hospital environment

Surge

IEC 61000-4-5

±0.5 kV, ±1

kV line to

line

±0.5 kV, ±1

kV, ±2

kV line to

ground

±0.5 kV, ±1 kV

line to line

±0.5 kV, ±1 kV,

±2

kV line to

ground

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 % U

(>95% dip

in U

for 0.5

cycle

<5 % U

(>95% dip

in U

)

for 1 cycle

70% U

(30% dip in

)

for 25/30

cycles

<5% U

(>95 % dip

in U

)

for 5/6 sec

<5 % U

(>95% dip in

for 0.5 cycle

<5 % U

(>95% dip in

)

for 1 cycle

70% U

(30% dip in U

)

for 25/30 cycles

<5% U

(>95 % dip in

)

for 5/6 sec

Mains power quality should be

that of a typical commercial

or hospital environment. If the

user of the models Ai-surgrey,

Surgic smart require continued

operation during power mains

interruptions, it is recommended

that the models Ai- surgrey,

Surgic smart be powered from an

uninterruptible power supply or a

battery.

Power

frequency

(50/60 Hz)

magnetic eld

IEC 61000-4-8

30A/m 30A/m Power frequency magnetic elds

should be at levels characteristic

of a typical location in a typical

commercial or hospital

environment

NOTE U

is the a.c. mains voltage prior to application of the test level.

Guidance & Declaration - Electromagnetic immunity

The models Ai-surgrey, Surgic smart are intended for use in the electromagnetic

environment specied below. The customer or the user of the models Ai-surgrey,

Surgic smart should assure that they are used in such an environment.

Immunity test

IEC 60601 test

level

Compliance

level

Electromagnetic environment

- guidance

Conducted

IEC 61000-4-

Radiated RF

lEC 61000-4-

3 Vrms

150 kHz to 80

MHz

6 Vrms in ISM

and amateur

radio bands

10 V/m

80 MHz to 2.7

GHz

385MHz-

5785MHz

Test

specication

s for

ENCLOSURE

PORT

IMMUNITY to

RF wireless

communicati

on equipment

(Refer to table 9

of IEC 60601-

2:2014)

3 Vrms

150 kHz to 80

MHz

6 Vrms in ISM

and amateur

radio bands

10 V/m

80 MHz to 2.7

GHz

385MHz-

5785MHz

Test

specication

s for

ENCLOSURE

PORT

IMMUNITY to

RF wireless

communicati

on equipment

(Refer to table 9

of IEC 60601-

2:2014)

Portable and mobile RF

communications equipment

should be used no closer to any

part of the models Ai- surgrey,

Surgic smart, including

cables, than the recommended

separation distance calculated

from the equation applicable

to the frequency of the

transmitter.

Recommended separation

distance

=[3,5/V

]×P

1/2

d=1.2×P

1/2

80 MHz to 800

MHz

d=2.3×P

1/2

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 xed RF

transmitters, as determined

by an electromagnetic site

survey,

should be less than

the compliance level in each

frequency range.

Interference may occur In the

vicinity of equipment marked

with the following symbol:

NOTE 1 At 80 MHz and 800 MHz. the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic

propagation is aected by absorption and reection from structures, objects and

people.

Field strengths from xed 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 xed RF transmitters, an

electromagnetic site survey should be considered. If the measured eld strength

in the location in which the models Ai-surgrey, Surgic smart is used exceeds

the applicable RF compliance level above, the models Ai-surgrey, Surgic

smart should be observed to verify normal operation. If abnormal performance

is observed, additional measures may be necessary, such as reorienting or

relocating the models Ai- surgrey, Surgic smart.

Over the frequency range 150 kHz to 80 MHz, eld strengths should be less

than 3V/m.

Recommended separation distances between

portable and mobile RF communications equipment and the models Ai-

surgrey, Surgic smart

The models Ai-surgrey, Surgic smart are intended for use in electromagnetic

environment in which radiated RF disturbances is controlled. The customer or

the user of the models Ai-surgrey, Surgic smart can help prevent electromagnetic

interference by maintaining a minimum distance between portable and mobile

RF communications equipment (transmitters) and the models Ai-surgrey, Surgic

smart 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

150kHz to 80MHz

d=1.2×P

1/2

80MHz to 80MHz

d=1.2×P

1/2

800MHz to 2.5GHz

d=2.3×P

1/2

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 1 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 aected by absorption and reection from structures, objects and

people

ZMN-SM-445 V1.0-20211220

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