Dowell PIEZOEX1 Instruction manual
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Content
1. Introduction .......................................................................................1
,GHQWL¿FDWLRQGDWD .............................................................................4
3. Testing of the device ..........................................................................5
4. Delivery ..............................................................................................6
/LVWRIPDWHULDOLQFOXGHGLQWKHVXSSO\ ...........................................6
,QVWDOODWLRQ.........................................................................................8
7. Controls ............................................................................................ 11
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5HJXODUPDLQWHQDQFH ......................................................................24
5HSODFHPHQWRIWKHIXVHV ..............................................................24
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7LSV ................................................................................................. 25
6\PEROV ..........................................................................................26
7URXEOHVKRRWLQJ.............................................................................26
7HFKQLFDOGDWD................................................................................29
16. After service ...................................................................................30
(QYLURQPHQWDOSURWHFWLRQ ........................................................... 30
0DQXIDFWXUHU¶VULJKW .................................................................... 30
*XDUDQWHH .......................................................................................30
6WDWHPHQW .......................................................................................32
'HFODUDWLRQRIFRQIRUPLW\(0&...................................................32
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:
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In the presence of electromagnetic interference environment, the device may be
malfunctioning. Do not install 3LH]R(; near equipment that releases
magnetic waves.
3LH]R(; requires special precautions for EMC and needs to be installed and
put into service according to the EMC environment.
Device with electromagnetic launcher will affect the normal operation of
3LH]R(;, 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.
'2:(//'(17$/ 352'8&76 is committed to continuous up-dating
of the products, which may entail changes to components of the
equipment. Ifthere 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
3LH]R(; 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;
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1.3 Intended Use
The 3LH]R(;is a piezoelectric device for bone surgerythat enables
osteotomy and osteoplasty techniques to be applied to in almost any anatomical
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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
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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
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the tissues.
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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.
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Do not use the Surgery-X(LED) on patients with pace-makers or other
implantable electronic devices. The same requirement applies also to the
operator.
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An electrosurgical knife could interfere with correct functioning of the device.
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SURGXFWV
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.
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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
WKHDFFHVVRULHVDUHH൶FLHQW'RQRWFDUU\RXWWKHWUHDWPHQWLIDQ\SUREOHPVDUH
encountered in operating the device. If the problems concern the equipment
contact an authorized technical service centre.
4
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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
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used. It is necessary to instruct the patient to breathe though his nose during the
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H[SORVLRQV
This equipment cannot function in places where there is an inflammable
atmosphere. (anaesthetic mixture, oxygen, etc)
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The foot switch of the Surgery-X(LED) must not be activated when the door of
the peristaltic pump open. (Fig.5—Ref.B).Moving parts could injure the operator.
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Do not carry out this treatment on metal or ceramic prosthetic artifacts. The
ultrasonic vibrations could lead to decrementing of such artifacts.
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After autoclave sterilizing of the handpiece, wait for it to cool down completely
before using itm.
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An exact description of the model including the serial number of the equipment
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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
Fig.1
2.3 Data plate of the scaler handpiece
The serial number of the Surgery-X(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.
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The material included in the supply may vary in case of promotional campaigns.
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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
Surgery-X(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
K
M
L
N
Fig.4
8
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6.1 Safety requirements during Installation
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UHOHYDQWHOHFWULFDOVDIHW\UHTXLUHPHQWV
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LQÀDPPDEOHDWPRVSKHUHVDQDHVWKHWLFPL[WXUHVR[\JHQHWF
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KHDW,QVWDOOLWVXFKDZD\WKDWWKHUHLVDQDGHTXDWHFLUFXODWLRQRIDLUDURXQG
LW/HDYHVX൶FLHQWIUHHVSDFHDURXQGLWLQSDUWLFXODUZLWKUHIHUHQFHWRWKH
IDQRQWKHUHDU)LJ
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RI89OLJKW
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ZLWKFDUHZKHQLWLVPRYHG
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9
WKHHOHFWULFDOFRQWDFWVDUHSHUIHFWO\GU\,IQHFHVVDU\GU\WKHPZLWKWKHDLU
syringe.
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FRQQHFWHGWRDVXSSO\PDLQVZLWKSURWHFWLYHHDUWK
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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 Surgery-X(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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10
The footswitch of the Surgery-X(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 Surgery-X(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;
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Fig.6
Fig.7
11
7. Controls
7.1 Description of the controls
This section illustrates the parts of the front panel of the Surgery-X(LED) unit,
enabling the controls described in this manual to be located immediately.
7.1.1Description of bone function:
Fig.8
7.1.2 Description of perio function:
Fig.9
12
7.1.3 Description of Endo function:
Fig.10
7.1.4 Description of clean function:
Fig.11
7.2 Description of the display and functions
There are three functions of bone root, clean for this Surgery-X(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
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.
13
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.
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Do not use the Surgery-X(LED) on patients with pacemakers or other implantable
electronic devices. This requirement also applies to the operator.
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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
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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.
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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.
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Do not carry out this treatment on metal or ceramic prosthetic artifacts. The
ultrasonic vibrations could lead to decrementing of such artifacts.
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After autoclave sterilizing of the handpiece, wait for it to cool down completely
before using it.
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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
14
cycle. If necessary, dry the contacts by blowing air onto them with the syringe.
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IRRWVZLWFKDQGVWDUWLWXSZLWKRXWOHWWLQJWKHWLSUHVWRQWKHSDUWWREH
WUHDWHG7KLVZLOODOORZWKHHOHFWURQLFFLUFXLWWRGHWHFWWKHSRLQWZKHUH
UHVRQDQFHRIWKHWLSLVZLWKRXWDQ\LQWHUIHUHQFHWKXVHQDEOLQJRSWLPXP
SHUIRUPDQFH
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.
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SDVVHG
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.
15
Warning code Warning description Solution
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;
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against it;
7.5.3 To use the torque wrench correctly (Fig.7) proceed as follow;
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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 Surgery-X(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
SRZHUUHTXLUHGGL൵HUHQWIURPWKHW\SHWKDWKDVEHHQVHWXVHNH\³0´RQ0XOWL
founction foot pedal to switch;
7.5.6 Check the display to see the power level that has been set, if the type of
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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;
16
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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
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The cleaning, disinfection and sterilization of handpiece, Torque wrench,Pump
tube, Support for the handpiece,Brine bottle connector,Connection for the cord
and tube of the peristaltic pump,tips,tip holder,Surgical tray and Silica gel support
for the handpiece are as follow.Unless otherwise stated, they will be hereinafter
referred to as “products”.
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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.
17
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3URFHVVLQJOLPLW
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, support for the
handpiece, torque wrench and surgical tray is 1000 times.
8.1 Initial processing
8.1.1Processing 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
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HTXLSPHQWDQGSURGXFWVSHFL¿FSURFHGXUHVDUHXVHGIRUFOHDQLQJGLVLQIHFWLRQDQG
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:
8OWUDVRQLFERQHVXUJHU\LVRSHUDWHGLQÀXVKLQJPRGHIRUVHFRQGVWRÀXVK
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);
1RWH
1)The package used conforms to ISO 11607;
18
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;
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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;
1RWH
a)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
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