Woodpecker ULTRASURGERY Instruction manual

ULTRASURGERY
MANUAL OF USE AND MAINTENANCE
Industrial design patent No.: CN 200830301694.8

Content
1. Introduction------------------------------------------------------------------------------1
1.1 Forward-----------------------------------------------------------------------------1
1.2 Description of the device----------------------------------------------------------1
1.3 Intended use-------------------------------------------------------------------------2
1.4 Safety requirement-----------------------------------------------------------------2
2. Identication data-----------------------------------------------------------------------5
2.1 Identication data------------------------------------------------------------------5
2.2 Data plate of the device-----------------------------------------------------------5
2.3 Data plate of the ULTRASURGERY handpiece--------------------------------5
3. Testing of the device-------------------------------------------------------------------6
4. Delivery----------------------------------------------------------------------------------6
5. List of material included in the supply-----------------------------------------------6
6. Installation-------------------------------------------------------------------------------9
6.1 Safety requirements during Installation-----------------------------------------9
6.2 Initial installation-----------------------------------------------------------------10
6.3 Connection the accessories------------------------------------------------------10
7. Controls---------------------------------------------------------------------------------12
7.1 Description of the controls-------------------------------------------------------12
7.2Description of the display and functions----------------------------------------13
7.3 Safety requirements during use-------------------------------------------------14
7.4 Protection systems and alarms--------------------------------------------------15
7.5 Instruction for use-----------------------------------------------------------------16
7.6 Rules for keeping the device in proper working order------------------------17
7.7 Settings permitted according to insert type------------------------------------17
8. Cleaning, disinfection and sterilization---------------------------------------------18
8.1 CLEAN function—Cleaning of the liquid circuit----------------------------18
8.2 Cleaning and disinfecting the casing of the apparatus------------------------18
8.3 Sterilization procedure-----------------------------------------------------------19
8.4 Autoclave sterilization of the handpiece---------------------------------------19
8.5 Autoclave sterilization of the tips-----------------------------------------------20

8.6 Autoclave sterilization of the torque wrench----------------------------------21
8.7 Autoclave sterilization of the peristaltic pump tube--------------------------21
8.8 Autoclave sterilization of the connection between cord and peristaltic pump
tube connection------------------------------------------------------------------------21
8.9 Autoclave sterilization of the handpiece support------------------------------21
9. Regular maintenance------------------------------------------------------------------21
10. Replacement of the fuses------------------------------------------------------------22
11. Disposal procedures and precautions----------------------------------------------23
12. Tips-------------------------------------------------------------------------------------23
13. Symbols-------------------------------------------------------------------------------24
14. Troubleshooting----------------------------------------------------------------------25
15. Technical data-------------------------------------------------------------------------28
16. After service---------------------------------------------------------------------------30
17. Environmental protection-----------------------------------------------------------30
18. Manufacturer’s right-----------------------------------------------------------------30
19. For technical data, please contact--------------------------------------------------30
20. Declaration of conformity-----------------------------------------------------------31
21. Guarantee------------------------------------------------------------------------------36
22. Statement------------------------------------------------------------------------------38

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)
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

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Thanks to its controlled three-dimensional ultrasound oscillations, the original
ULTRASURGERY 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 effect: Maximum intra-operative visibility (bloodless eld);
The equipment has an automatic tuning circuit that offsets wear of the tips, thus
ensuring work in constant conditions of maximum efciency.
1.3 Intended Use
The ULTRASURGERY 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;

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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
effects. 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 ULTRASURGERY 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.

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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 ef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 off 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 ULTRASURGERY 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.

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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 ef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 Ultrasurgery handpiece is engraved on the ring nut
(Fig.2).
Fig.2

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2.4 Data plate of the foot switch
Fig.3
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
Peristaltic pump 1 Fig.4—Ref.A
Device 1 Fig.4—Ref.B

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Name Quality Ref
Torque wrench 1 Fig.4—Ref.C
ULTRASURGERY
handpiece complete with
cord
1 Fig.4—Ref.D
Connection for the cord
and tube of the peristaltic
pump
1 Fig.4—Ref.E
Connector of handpiece 1 Fig.4—Ref.F
Plug of Footswitch 1 Fig.4—Ref.G
Footswitch 1 Fig.4—Ref.H
Tip Holder Marked on the packing
list
Fig.4—Ref.I
Tip Marked on the packing
list
Fig.4—Ref.J
Input of power-supply
cable
1 Fig.4—Ref.K
Output of power-supply
cable
1 Fig.4—Ref.L
Surgical tray 1 Fig.4—Ref.M
Rod for supporting the bag 1 Fig.4—Ref.N
Support for the handpiece 1 Fig.4—Ref.O
Pump tube 1 Fig.4—Ref.P