Dentsply Sirona VDW 6:1 User manual

New as of:
Neu ab:
Nuovo a partire da:
Nuevo a partir de:
Nouveau depuis:
07.2019
VDW 6:1
Instructions for use
Gebrauchsanweisung
Istruzioni d'uso
Manual del operador
Notice d'utilisation
English / Deutsch / Italiano / Español / Français

New as of:
07.2019
VDW 6:1
Instructions for use
English

Table of contents Dentsply Sirona
Instructions for use VDW 6:1
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Table of contents
1Before you begin … ................................................................................................ 4
1.1 Structure of the document............................................................................ 4
1.1.1 Labeling of information................................................................... 4
1.1.2 Formats and symbols..................................................................... 5
1.2 Service life of Sirona Instruments ................................................................ 5
2Safety instructions .................................................................................................. 6
3Technical description .............................................................................................. 7
3.1 Task ............................................................................................................. 7
3.2 Structure of VDW 6:1 ................................................................................... 7
3.3 Technical Data ............................................................................................. 7
3.4 Product labeling ........................................................................................... 8
4Pre-operation .......................................................................................................... 9
4.1 Initial start-up and longer breaks in use ....................................................... 9
5Operation ................................................................................................................ 10
5.1 Replacing the instrument ............................................................................. 10
5.2 Attaching and removing a file....................................................................... 10
5.3 Recommendation for the treatment procedure ............................................ 10
5.4 Fitting and removing a silicon sleeve ........................................................... 12
6Post-operation ........................................................................................................ 13
6.1 After each treatment session ....................................................................... 13
7Reprocessing.......................................................................................................... 14
7.1 Pre-treatment ............................................................................................... 14
7.2 Automated cleaning and disinfection ... ....................................................... 14
7.2.1 ... with a DAC Universal................................................................. 14
7.2.2 ... with cleaning and disinfection equipment .................................. 14
7.3 Manual cleaning and disinfection................................................................. 15
7.4 Manual maintenance.................................................................................... 16
7.4.1 Maintenance of mechanical parts .................................................. 16
7.4.2 Care of the push button chuck....................................................... 16
7.5 Sterilizing ..................................................................................................... 17
8Recommended agents............................................................................................ 18

Dentsply Sirona
Instructions for use VDW 6:1
Table of contents
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9Spare parts and consumables ................................................................................ 19
10 Disposal .................................................................................................................. 20

1 Before you begin …
1.1 Structure of the document
Dentsply Sirona
Instructions for use VDW 6:1
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1Before you begin …
VDW 6:1 complies with the regulations taking into account the state of
the art. VDW 6:1 complies with the ISO 14457 standard.
1. Read the operating instructions prior to using VDW 6:1.
2. Use VDW 6:1 only for the applications described in the operating
instructions.
3. Observe the hygiene standards, occupational safety regulations,
and accident prevention measures applicable to the VDW 6:1 in
your country.
Intended use VDW 6:1 is used to hold and drive burs for the purposes of rotary
processing and is intended for the following uses in dentistry:
● Endodontics
● Endometry
Contraindications none
Target group This product is intended only for use by trained dental personnel in
dental practices and laboratories.
1.1 Structure of the document
1.1.1 Labeling of information
Warnings ➢ To prevent injuries, please observe the warnings.
Warnings are labeled as follows:
DANGER! indicates a danger leading to death or serious injury if not
avoided.
WARNING! indicates a danger that may lead to death or serious
injury if not avoided.
CAUTION! indicates a danger that may lead to injury if not avoided.
Instructions for use ➢ To prevent material damage and additional expenses, please
observe all instructions for use.
Instructions for use are labeled as follows:
NOTE! indicates measures for the prevention of material damage.
IMPORTANT: indicates information on the avoidance of additional
expenses and other important information.
Tip: indicates information for facilitating work.

Dentsply Sirona
Instructions for use VDW 6:1
1 Before you begin …
1.2 Service life of Sirona Instruments
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1.1.2 Formats and symbols
The formats and symbols used in this document have the following
meaning:
üPrerequisite
1. First action step
2. Second action step
or
➢ Alternative action
ÄResult
➢ Individual action step
Requests you to do some-
thing.
Use of formats and sym-
bols [→5].
Identifies a reference to an-
other text passage and
specifies its page number.
● List Identifies a list.
1.2 Service life of Sirona Instruments
When used as intended:
● non-moving parts of Dentsply Sirona instruments have a typical
service life of approx. 5 years
● moving parts of Dentsply Sirona instruments have a typical service
life of approx. 3 years
No warranty claim can be inferred here, as wear may occur earlier or
later than indicated above depending on use, frequency of sterilization,
and frequency of maintenance.
Elastomers, e.g. O-rings, must be replaced depending on their degree
of wear.

2 Safety instructions Dentsply Sirona
Instructions for use VDW 6:1
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2Safety instructions
Obligations of the user ● Use only fault-free materials that do not deviate from the specified
data [→7].
● Protect yourself, patients, and others from danger. To do this,
observe the safety information.
● Comply with the Intended use of the equipment.
● You should always keep these operating instructions within reach for
further reference.
Preventing the spread of infections and
cross contamination
Prevent the spread of infections and cross contamination between
patients, users, and third parties. Sterilize equipment after each patient.
Take the appropriate hygiene measures, e.g. wear protective gloves.
Instrument head overheating If the instrument is defective, the area around the instrument head may
heat up, thus creating a risk of burning the patient's oral mucosa.
Malfunction or damage Discontinue use immediately in case of malfunction, unusual or different
sounds or damage. Damaged instruments may cause injury. Notify the
dental depot or the manufacturer.
Repair Do not repair the instrument yourself.
Spare and accessory parts Use only original parts produced by the manufacturer.
First aid measures in the case of
lubricant accidents General information: Immediately remove any clothing soiled
by the product.
After inhalation: Supply fresh air; consult doctor in case
of complaints.
After skin contact: If skin irritation continues, consult a doc-
tor.
After eye contact: Rinse opened eye for several minutes
under running water.
After swallowing: If symptoms persist consult doctor.
For details download the Dentsply Sirona T1 Spray Material Safety Data
Sheet from the Dentsply Sirona homepage: www.dentsplysirona.com
Operating conditions: Temperature: +10 °C – +35 °C.
If you have any questions, please contact your dental supplies
distributor or the manufacturer.

Dentsply Sirona
Instructions for use VDW 6:1
3 Technical description
3.1 Task
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3Technical description
3.1 Task
The instrument serves for transmitting the driving power and speed of
the electric motor or air motor (handpiece coupling according to ISO
3964) to the preparation tool.
3.2 Structure of VDW 6:1
Contra-angle handpiece
C
B
A
A Instrument head
B Push button
C Opening for the clamping system
Accessories
A Silicon sleeve
B File
3.3 Technical Data
Instrument
VDW 6:1
Gear ratio 6:1
Maximum motor speed in rpm 40 000
Maximum operating speed in rpm 6 700
Clamping system CA
Internal cooling media -
Back suction stop -
Light function -
Apex measuring function I x
Instrument coupling INTRAmatic®
IApex measuring function depending on the treatment center and its accessories

3 Technical description
3.4 Product labeling
Dentsply Sirona
Instructions for use VDW 6:1
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File
VDW 6:1
Shank diameter in mm 2.334 - 2.350
Maximum total length in mm 25
Maximum working diameter in mm
(ISO 2157)
2.1
Gripping length in mm ≥ 11
Standard ISO 1797, Type 1
0123
This product bears the CE marking in accordance with the provisions of
Council Directive 93/42/EEC of June 14, 1993 concerning medical
devices.
3.4 Product labeling
Can be thermal
disinfected
13 °C5
Sterilizable in a
steam sterilizer
(autoclave) at the
temperature speci-
fied
20XX
Date of manufac-
ture
Serial Number
Data matrix code (here: an example)
Content of the data matrix code:
BCD
+E27659942770/$$+5192/16D20170309E
A
A
B
C
D
Manufacturer code (here: E276)
REF number (here: 5994277)
Serial no. (here: 5192)
Manufacture date (YYYYMMDD)

Dentsply Sirona
Instructions for use VDW 6:1
4 Pre-operation
4.1 Initial start-up and longer breaks in use
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4Pre-operation
4.1 Initial start-up and longer breaks in use
➢ Sterilize the instrument and accessories prior to startup.
➢ Clean and maintain the instrument after longer breaks in use.

5 Operation
5.1 Replacing the instrument
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Instructions for use VDW 6:1
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5Operation
NOTE! Use only faultless files in order to prevent fatigue fractures of
the files as far as possible.
CAUTION! Never pull the patient's cheek back with the contra-angle
handpiece! This would actuate the pushbutton, thus creating a risk of
burning the patient's oral mucosa.
IMPORTANT:For application details and operating data of the different
preparation tools, please refer to the information provided by the
manufacturer.
5.1 Replacing the instrument
CAUTION! The instrument should only be fitted or removed when the
motor is at standstill.
Attaching the VDW 6:1
üThe motor is at a standstill.
➢ Insert the instrument until it snaps into place.
Removing the VDW 6:1
üThe motor is at a standstill.
➢ Detach the instrument. Do not pull on the supply hose while doing
this.
5.2 Attaching and removing a file
NOTE! Use only faultless files in order to prevent fatigue fractures of
the files as far as possible.
IMPORTANT: Check the push button to make sure it moves freely!
Attaching a file
üThe drive has come to a stop.
1. Insert the file by gently rotating it until it snaps into place. In doing
so, do not press the pushbutton.
2. Then pull and turn the file to check that it is firmly seated.
Removing a file
üThe file has come to a stop.
➢ Remove it while pressing and holding down the pushbutton.
5.3 Recommendation for the treatment procedure
NOTE! Use only faultless files in order to prevent fatigue fractures of
the files as far as possible.
CAUTION! When using the ApexLocator function, use only
endodontic files with metal shafts to have a proper apex length
determination. Not using files with metal shaft may lead to an incorrect

Dentsply Sirona
Instructions for use VDW 6:1
5 Operation
5.3 Recommendation for the treatment procedure
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apex length determination and therefore to an under or over
instrumentation with risk of injury for the patient.
● The different file systems require different working techniques. For
this reason, please always observe the information provided by the
file manufacturer.
● Work without exerting any pressure on the file.
● The ApexLocator function of VDW 6:1 is used to support the root
canal preparation processwhen used in combination with a
treatment center with the apex length determination function. With
the VDW 6:1 the number of X-rays taken and the exposure to X-rays
to the patient and to the operator can be decreased. However, you
must always take at least one X-ray to determine the length for
preparatory work. A clinical evaluation including knowledge of the
anatomy of root canals is important for interpreting the results.
!
● When performing the Apex length determination, wear appropriate
insulated gloves. We recommend performing the treatment with a
cofferdam, while using a silicon sleeve. This will prevent inaccurate
length determination caused by undesired leakage currents. Avoid
the contact of the instrument with the patient's mucosa, metallic
tooth restorations, or the mucosal electrode.
● If the limit torque is exceeded, a gentle creaking may be heard and
vibrations felt. Remove the file by gently pulling it toward the coronal
end. If this is not possible, switch the drive into the opposite rotation
direction and pull the file out of the channel.
IMPORTANT: Check the file afterwards for damage or deformation
(untwisting) and replace it, when necessary.

5 Operation
5.4 Fitting and removing a silicon sleeve
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Instructions for use VDW 6:1
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5.4 Fitting and removing a silicon sleeve
WARNING! The silicon sleeve is not sterile! To avoid cross-
contamination sterilize the silicon sleeve before use [→17].
NOTE! Silicon sleeves are for single use only. Change the silicon
sleeve after each patient.
Fitting a silicon sleeve
üYou have sterilized the silicon sleeve.
üThe motor is at a standstill.
üA file is not clamped in place.
1. Pull the silicon sleeve fully over the instrument by gently turning it
from one side to the other.
2. Insert the file [→10].
3. Attach the contra-angle handpiece to the motor.
Removing a silicon sleeve
üThe motor is at a standstill.
1. Pull the contra-angle handpiece off of the motor.
2. Remove the file.
3. Remove the silicon sleeve.
4. Dispose of the silicon sleeve [→20].

Dentsply Sirona
Instructions for use VDW 6:1
6 Post-operation
6.1 After each treatment session
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6Post-operation
6.1 After each treatment session
NOTE! Condition immediately, or at the latest, one hour after treatment.
NOTE! Use only Dentsply Sirona T1 Spray.
üWear appropriate protective clothing.
1. Remove the file with tweezers.
2. Pre-disinfect directly at the treatment center/tabletop unit.
3. Detach the instrument from the motor.
4. Transport the instrument to the hygiene room in a suitable transport
container.
5. Conduct automatic reprocessing [→14]. Manual conditioning
[→15] is possible in exceptional cases if the national/local
regulations are followed.
6. Apply spray to the instrument [→16].
7. Sterilize the instrument and accessories [→17].

7 Reprocessing
7.1 Pre-treatment
Dentsply Sirona
Instructions for use VDW 6:1
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7Reprocessing
7.1 Pre-treatment
üWear appropriate protective clothing.
üAll disinfectants must be approved in your country and have proven
bactericidal, fungicidal and virucidal properties. Use only
disinfectants with no protein-fixing properties.
More information to Dentsply Sirona recommended disinfectants
can be found in chapter "Recommended agents [→18]".
1. Wipe the surface with a disinfectant cloth.
2. Wipe the disinfectant off with a cloth.
ÄFor further reprocessing, the instrument should be dry and free of
residue.
Please observe the manufacturer's instructions for using the instrument
disinfectant.
7.2 Automated cleaning and disinfection ...
7.2.1 ... with a DAC Universal
DAC Universal
We recommend using Dentsply SironaDACUniversal for automated
cleaning, disinfection, care, and unwrapped sterilization.
For further details, refer to the operating instructions supplied with the
unit.
üThe pushbutton chuck is manually maintained [→16].
üThe instrument is conditioned using the DAC Universal.
1. Check whether the instrument is clean after reprocessing under
good lighting (min. 500 lux) and color rendering index (min. 80 Ra).
2. If they are still dirty, repeat the process.
ÄFor further reprocessing, the instrument should be dry and free
of residue.
3. Pack the instrument in packaging material suitable for sterilization
and storage. e.g. paper/plastic composite packaging.
4. Conduct sterilization [→17].
7.2.2 ... with cleaning and disinfection equipment
The instrument can also be cleaned and disinfected in a suitable piece
of cleaning and disinfection equipment.
The cleaning and disinfection equipment used must be approved by its
manufacturer for the cleaning and disinfection of dental instruments and
comply with ENISO15883-1 (e.g. 95°C (203°F) and 10 min. holding
time). We recommend a mildly alkaline cleaner with a pH lower than 10.
For further details, refer to the operating instructions supplied with the
unit.

Dentsply Sirona
Instructions for use VDW 6:1
7 Reprocessing
7.3 Manual cleaning and disinfection
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üThe instrument is conditioned with a cleaning and disinfection
device.
1. Check whether the instrument is clean after reprocessing under
good lighting (min. 500 lux) and color rendering index (min. 80 Ra).
2. If they are still dirty, repeat the process.
ÄFor further reprocessing, the instrument should be dry and free
of residue.
3. Blow the instrument out with max. 3 bar.
4. Maintain mechanical parts manually [→16].
5. Maintain the push button chuck manually [→16].
6. Pack the instrument in packaging material suitable for sterilization
and storage. e.g. paper/plastic composite packaging.
7. Conduct sterilization [→17].
7.3 Manual cleaning and disinfection
IMPORTANT: Manual reprocessing is possible in exceptional cases if
the national/local regulations are followed. The national/local regulations
are to be checked before.
NOTE! Condition immediately, or at the latest, one hour after treatment.
NOTE! Never clean in an ultrasonic bath!
NOTE! Never immerse in disinfectants!
NOTE! Use only Dentsply Sirona T1 Spray.
IMPORTANT: Use a soft, clean, and disinfected brush for cleaning.
üWear appropriate protective clothing.
üAll disinfectants must be approved in your country and have proven
bactericidal, fungicidal and virucidal properties. Use only
disinfectants with no protein-fixing properties.
More information to Dentsply Sirona recommended disinfectants
can be found under Recommended agents [→18].
1. Brush the instrument under running water (<38°C, <100°F, at
least drinking water quality) and good lighting (min. 500 lux) and
color rendering index (min. 80 Ra) until no more dirt can be seen,
for at least 10 seconds.
2. Flush the drive channels for 1-2 seconds with Dentsply Sirona T1
Spray.
3. Conduct thermal disinfection or unwrapped steam sterilization
[→14].
4. Lubricate mechanical parts manually [→16].
5. Maintain the push button chuck manually [→16].
6. Pack the instrument in packaging material suitable for sterilization
and storage. e.g. paper/plastic composite packaging.
7. Conduct sterilization [→17].

7 Reprocessing
7.4 Manual maintenance
Dentsply Sirona
Instructions for use VDW 6:1
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7.4 Manual maintenance
7.4.1 Maintenance of mechanical parts
Intervals
● Prior to each sterilization
● After every thermal disinfection without integrated maintenance
Required accessories
A
B
C
A Spray adapter
B O-ring for spray adapter
C T1 Spray
NOTE! Use only Dentsply Sirona T1 Spray.
Procedure
üThe spray adapter is disinfected.
üThe O-ring on the spray adapter is intact.
1. Fit the spray adapter onto the nozzle of the spray can.
2. Insert the instrument until it snaps into place and hold it.
3. Spray the instrument for 1 - 2 seconds.
IMPORTANT: Hold the spray can upright.
4. Wipe any spray that comes out with a disinfection cloth.
5. Repeat the process until the spray that comes out of the instrument
is clear.
7.4.2 Care of the push button chuck
Use Dentsply Sirona T1 Spray on the push-button chuck to remove
deposits and ensure proper functioning of the clamping system.
Interval
● At least once a week
Required accessories
A
B
A Black nozzle insert
B Dentsply Sirona T1 Spray
NOTE! Use only Dentsply Sirona T1 Spray.
Procedure
üThe instrument is clean and disinfected.
1. Press the contra-angle handpiece head with the chuck firmly
against the spray can nozzle.
2. Spray the chuck for 1-2 seconds.
IMPORTANT: Hold the spray can upright.
3. Wipe any spray that comes out with a disinfection cloth.

Dentsply Sirona
Instructions for use VDW 6:1
7 Reprocessing
7.5 Sterilizing
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7.5 Sterilizing
Intervals:
● Prior to initial operation
● Prior each subsequent use
Procedure
üThe instrument is clean and disinfected.
üInstrument maintenance is complete.
üThe instrument must be packed in a packaging suitable for
sterilization and storage, e.g. paper/plastic composite packaging or
container.
➢ Sterilize the instrument and the accessories in the steam sterilizer
with saturated water vapor.
Overpressure: 2.04bar (29.59psi)
Temperature: 135° C (275° F)
Holding time: 3 min.
DAC Professional Plus
+
_
_
0
Steam sterilizers that comply with either EN13060 class B (for
example, DAC Premium / DAC Professional) or EN13060 classS and
are also suitable for the sterilization of straight/contra-angle handpieces
are approved.
NOTE! Do not exceed 140°C (284°F), even during the drying phase.
After sterilizing
1. Remove the instrument from the steam sterilizer immediately.
CAUTION! The instrument is hot. Risk of burns!
NOTE! Do not attempt to accelerate the cooling process by
immersing the instrument in cold water. This can damage your
instrument.
2. Store all instruments so that they are protected from contamination
(dry, cool and dark).
3. Sterilize again once the storage period has elapsed.

8 Recommended agents Dentsply Sirona
Instructions for use VDW 6:1
18 61 34 378 D3451
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8Recommended agents
A continuously updated list of Dentsply Sirona recommended agents
can be downloaded from the Internet on the online portal for technical
documents. You can reach this portal at the address:
www.dentsplysirona.com/manuals
Click on the menu item "General documents" and then open the "Care,
cleaning and disinfection agents" document.
If you do not have access to the Internet, you can order the list (REF 59
70 905) in one of the following two ways:
● Order from your local dental depot
● Order from Dentsply Sirona:
Phone: [phone] / 16-16 70
Fax: [phone] / 16-18 18

Dentsply Sirona
Instructions for use VDW 6:1
9 Spare parts and consumables
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9Spare parts and consumables
Use only original parts produced by the manufacturer.
REF REF
Dentsply Sirona T1 Spray (6
x 250 ml cans)
59 01 665 Spray adapter (ISO) for
spray can
89 17 858
O-ring for spray adapter 70 36 353 Silicon sleeve for Endo 63 24 631