Woodpecker surgic touch (LED) Instruction manual

Content
1. Introduction .......................................................................................1
2. Identication data .............................................................................4
3. Testing of the device ..........................................................................5
4. Delivery ..............................................................................................6
5. List of material included in the supply ...........................................6
6. Installation .........................................................................................8
7. Controls ............................................................................................ 11
8. Cleaning ,disinfection, Sterilization and maintenance .................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 ....................................................................29
19.Guarantee .......................................................................................29
20. Statement .......................................................................................30
21.Declaration of conformity- EMC...................................................30

1
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 Touch(LED) near equipment that releases
magnetic waves.
Surgic Touch(LED) 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
Touch(LED) , 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

2
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 Touch (LED) 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 Touch (LED) 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.

3
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 Touch (LED) 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.

4
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 switch of the Surgic Touch (LED) 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 itm.
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).

5
LED
Fig.1
2.3 Data plate of the scaler handpiece
The serial number of the Surgic Touch (LED) 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.

6
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-founction foot pedal 1 Fig.4—Ref.B
Normal saline 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 Touch (LED) handpiece
complete with cord 2 Fig.4—Ref.G
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

7
A
D
B
G
H
J
C
E
F
K
M
L
N
Fig.4

8
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

9
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 Touch
(LED):
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).

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Danger: personnel injury.
The footswitch of the Surgic Touch (LED) 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 footswitch to the casting of the device by inserting the plug
into the footswitch 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 Touch (LED) 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

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7. Controls
7.1 Description of the controls
This section illustrates the parts of the front panel of the Surgic Touch (LED)
unit, enabling the controls described in this manual to be located immediately.
7.1.1Description of bone function:
Water
increase/decrease
Power
increase/decrease
Bone function
Fig.8
7.1.2 Description of perio function:
Water
increase/decrease
Power
increase/decrease
Perio function
Fig.9

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7.1.3 Description of Endo function:
Water
increase/decrease
Power
increase/decrease
Endo function
Fig.10
7.1.4 Description of clean function:
Clean function
Fig.11
7.2 Description of the display and functions
There are three functions of bone root, clean for this Surgic Touch (LED).
7.2.1 BONE function (Fig.8)
In bone function, both the water and power model are available.Seven power
levels as follows:
a)Power 6-7: Very high bone density
b)Power 4-5: High bone density

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c)Power 3-4: Middle bone density
d)Power 2-3: Low bone density
e)Power 1: Very 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.
7.2.2 ENDO function (Fig.10)
In this function, both the water and power model are available, one model as
follow:Endo.
7.2.3 CLEAN function (Fig.11)
In this function, press the footswitch, the device can clean the tube .(Recommed
at least 25 seconds)
7.3 Safety requirements during use.
Danger: Contraindications.
Do not use the Surgic Touch (LED) 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.

14
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
footswitch 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.

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Warning code Warning description Solution
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 Touch (LED) handpiece until it is
ush 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 Touch (LED) 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.

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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
US1-US2-US3-US4-US5-US6-
US1L-US1R
BONE Power1-Power7
UL1-UL2-UL3-UL4-UL5 BONE Power1-Power7
UC1 BONE Power1-Power1
UI1-UI2-UI7-UI8-UI9 BONE Power1-Power7
UP1-UP2-UP3-UP4-UP5-UP6-
UP7
Perio Power1-Power7
UE1-UE2-UE3-UE4 Endo Power1-Power7
8. Cleaning ,disinfection, Sterilization and
maintenance
8.1 Preparation
Basic principles
It is only possible to carry out effective sterilization after the completion of
effective cleaning . Please ensure that, as part of your responsibility for the
sterility of products during use, only sufficiently validated equipment and

17
product-specic procedures are used for cleaning 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. This applies especially with
regard to the additional requirements for the inactivation of prions.
Our methods of cleaning and sterilization are veried to be eective.The cleaning
and sterilization procedure apply to the accessories .
8.2 Cleaning :Automated Cleaning
Notice: tips, tip holder, torque wrench, pump line, handpiece holder, silicone
handpiece holder, and pump line connector can be automated cleaning with a
washer-disinfector.
Thermal disinfection should be used if this function is available on your washer-
disinfector.Use if possible a disinfecting cycle compliant with the standard EN
ISO 15883.
Note that there is a risk of disinfectant residue on products when using chemical
disinfectants.
Ensure the following criteria are met when selecting a washer-disinfector system:
• Washer-disinfector is proven eective through testing (e.g. FDA approved or
CE marked / EN ISO 15883 compliant).
• Washer-disinfector has suitable baskets to hold small fragile products and has
rinsing connections for the attachment to product lumina.
• The cleaning program is suitable for products to be processed and the rinsing
cycle is sucient.
• Only low microbe count (<10 cfu/ml) distilled or deionized water is used for
all rinsing steps. (E.g. Aqua puricata, as per the specications of Pharm. Eur. or
USP).
Washer-disinfectoris serviced and checked on a regular basis.
8.2.1 Steps for automated cleaning with a washer-disinfector
a. Carefully place the products in the disinfection basket. Fastening of the
products is only permissible if they are freely moveable in the fixture. The
products are not permitted to make contact with one another.

18
b. Using a suitable rinsing adaptor, connect the product lumina to the rinsing
connections of the disinfector.
c. Start the program.
d. Remove the products from the disinfector and start the inspection (see section
Inspection and maintenance) after the program ends.
e. Wrap the products directly fol lowing disinfection and drying (see section
Packaging and sterilization). If necessary, repeat drying of the product in a clean
place.
Sequence and parameters applicable to the cycle:
- 3 mins., Pre-wash with cold water;
- 5 mins., Washing with 0,5% neutral pH detergent at 45°C;
- 2 mins., Rinsing with tap water;
- 2 mins., Rinsing with cold demineralised water;
- 5 mins., Thermodisinfection at 93°C with demineralised water.
The automated thermodisinfection was not experimentally tested. According to
standard ISO 15883-1, Table 2.1 [4] the thermodisinfection at a temperature of
90°C for 5 mins. determines an A0 value of 3000);
WARNING: The automatic cleaning cycle, as described above, must always be
preceded by the manual cleaning steps.
8.2.2 Auto Cleaning Mode to clean pipeline
a) Change the bag containing water (demineralized water is recommended);
b) Check whether the water system is connected correctly;
c) Start the CLEAN function (Fig.11);
d) Press the footswitch to start the cleaning cycle, as soon as the peristaltic pump
starts up, a status bar will appear on the display to indicate progressively the
time remaining to completion of the tempo CLEAN cycle. The cycle lasts for 25
seconds and cannot be stopped;
e) Once the cleaning cycle has been completed, the device exits from the CLEAN
function and returns to BONE function (Fig.9);
f) On completion of the cleaning operations, empty the tubes and dry the
accessories that have been through the cleaning cycle.