Instructions for Use and Re-Processing of VDW Products

VW000304 Rev. 7 / 28.03.17

VDW GmbH
R Bayerwaldstr. 15 • 81737 Munich • Germany
Tel. +49 89 62734-0 • Fax +49 89 62734-304
www.vdw-dental.com • [email protected]
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Re-Processing in Line with DIN EN ISO 17664/AAMI ST81 Part 1

General principles guidelines regarding prion inactivation (does not apply to the
USA).
All instruments must be cleaned, disinfected and sterilised prior
to each use; this applies the first time instruments supplied in Cleaning and disinfection
a non-sterile condition are used, to instruments delivered in
a sterile condition that are intended for repeated use, and to Basic Principles
damaged or opened sterile packaging. Thorough cleaning and We recommend an automated procedure to clean and disinfect
disinfection are essential prerequisites for effective sterilisation. the instruments (washer-disinfector). A manual method-
including the use of an ultrasonic bath, should only be used
As part of your responsibility for instruments sterility, always if it is not possible to use an automated method, as it is less
make sure that only validated methods for cleaning/disinfection effective and demonstrates a lower reproducibility. The pre-
and sterilisation are used, that devices (washer-disinfector, treatment process should be performed in every case.
thermal disinfector or steriliser) are regularly serviced and
inspected and that the validated parameters are maintained Pre-Treatment at the place of use
with each cycle. For your own safety, always wear protective Cross contamination (particularly pulp and dentine remnants)
gloves, glasses and a mask when handling contaminated must be removed immediately after the instrument has been
instruments. used on a patient (within maximum 2 hrs).

In addition, always observe all applicable national legal The following procedures must be used to ensure that any
regulations (e.g. KRINKO/RKI/BfArM Re-Processing contamination on the instruments cannot dry on and to make
recommendations) and regulations on hygiene relating to subsequent preparation more effective:
your practice or the hospital.. This applies in particular to the

Procedure A: Procedure B: Procedure C:

Instruments that fit in the interim stand Instruments that do not fit in the interim stand (see Boxes and modules
(see Table 3) Table 3) (see Table 3)
• Place in the interim stand prior to pre-disinfection/ • Place in a pan containing disinfecting agent within • Within two hours, clean to remove contamination under
cleaning and for transport (minimum storage time two hours (minimum storage time according to the flowing water at least 3 x 1 min. on the outside and
according to the disinfecting agent manufacturer’s disinfecting agent manufacturer’s directions for use: particularly on the inside.
directions for use: Max. two hours). Max. two hours) and brush at both the start and end • Then place in a pan (not together with the
• A prepared interim stand with a new foam disc must of pre-treatment. instruments!).
be used for each patient. The interim stand must be • The pan is also used to transport the instruments. • The pan is also used to transport the boxes and
filled at least two thirds of the way with disinfecting modules.
agent.
The following must be taken into account when selecting a disinfecting agent: Use only low-germ (< 10 CFU/ml) water (e.g.
• It must be suitable for disinfecting instruments made from metal and plastic; purified water (PW)); tap water that is particularly
• It must be aldehyde-free (Cidex OPA is permitted due to its special recipe); hard (≥ 14 °dH) is not suitable for this (risk of lime
residue).
• Its effectiveness must have been verified (e.g. VAH/DGHM approval, FDA clearance or CE mark);
• It must be compatible with the instruments (see section “Important notes on material resistance”).

The concentration and minimum contact time specified by the disinfecting agent manufacturer must be
strictly adhered to. Only use freshly prepared solutions and low-germ (< 10 CFU/ml) water
(e.g. purified water (PW)).

Please note that the disinfecting agent used during pre-treatment is for personal protection only and is
not a substitute for the disinfection stage required after cleaning.

Warning: Under no circumstances may instruments that have already come into contact with disinfecting
agent be used to treat a patient again.

All further steps in the preparation process must be performed

on the same day.

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Re-Processing in Line with DIN EN ISO 17664/AAMI ST81

Preparation prior to cleaning

Procedure A: Procedure B: Procedure C:
Instruments that fit in the interim stand Instruments that do not fit in the interim stand (see Boxes and modules
(see Table 3) Table 3) (see Table 3)
• Remove the stopper from the instrument (if present, • Clean to remove contamination under flowing water at • Place in a pan containing cleaning agent for the
see Table 3) and dispose of it. least 3 x 1 minute; to remove contamination manually, prescribed contact time (but no less than
• Then clean to remove contamination under flowing use a soft, clean brush or soft, clean cloth that is only 15 minutes) and brush at both the start and end of
water at least 3 x 1 minute; to remove contamination used for this purpose; never use metal brushes or the contact time on the outside and particularly on the
manually, use a soft, clean brush or soft, clean cloth wire wool. inside for at least one minute each (using a soft, clean
that is only used for this purpose; never use metal • Check that no visible contamination or remnants brush; never use metal brushes or wire wool).
brushes or wire wool. remain, and repeat the pre-cleaning process if • Check that no visible contamination or remnants
• Check that no visible contamination or remnants necessary. remain, and repeat the pre-cleaning process if
remain, and repeat the pre-cleaning process if necessary.
necessary.
Use only low-germ (< 10 CFU/ml) water (e.g. purified water (PW)); tap water that is particularly hard The following must be taken into account when
(≥ 14 °dH) is not suitable for this (risk of lime residue). selecting a cleaning agent:
• It must be suitable for cleaning instruments made from
metal and plastic ;
• It must be compatible with the instruments (see
section “Important notes on material resistance”).
The concentration and minimum contact time
specified by the cleaning agent manufacturer must
be strictly adhered to.
Only use freshly prepared solutions and low-germ
(< 10 CFU/ml) water (e.g. purified water (PW)); tap
water that is particularly hard (≥ 14 °dH) is not
suitable for this (risk of lime residue).

Automated cleaning/disinfection (washer-disinfector)

The following must be taken into account when selecting a The following must be taken into account when selecting a
washer-disinfector: cleaning agent:

• The effectiveness of the washer-disinfector must have been • It must be suitable for cleaning the instruments;
verified (e.g. DGHM approval, FDA clearance or CE mark
• If a thermal disinfection process is not used, a suitable
according to EN ISO 15883);
disinfecting agent with verified effectiveness (e.g. VAH/DGHM
• Where possible, a tested thermal disinfection program must approval, FDA clearance or CE mark) must also be used and
be used (A0 value >3000 or at least five minutes at 90 °C, or this must be compatible with the cleaning agent used;
for older equipment at least 10 min. at 93 °C).
• The chemicals used must be compatible with the instruments
Warning: In the case of chemical disinfection, there is a risk of (see section “Important notes on material resistance”);
disinfecting agent residues remaining on the instruments.
• Neutralisation must not be necessary.
• The program used must be suitable for the instruments and The concentrations, temperatures and contact times specified
include the prescribed rinsing cycles; by the manufacturer of the cleaning agent and, where
applicable, disinfecting agent, must be strictly adhered to. Rinse
• Only sterile or low-germ (< 10 CFU/ml) and low-endotoxin aids must not be used.
(< 0.25 EU/ml) water (e.g. highly purified water HPW) must be
used for subsequent rinsing;
• The washer-disinfector must be regularly maintained and
inspected.
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Re-Processing in Line with DIN EN ISO 17664/AAMI ST81

Procedure A: Procedure B: Procedure C:

Instruments that fit in the interim stand Instruments that do not fit in the interim stand Boxes and modules
(see Table 3) (see Table 3) (see Table 3)
1. • If present (see Table 3): Fit new stoppers to the • Place in a sufficiently large screen basket (Minifix • Place in a sufficiently large screen basket with the
pre-cleaned instruments. measuring gauge: Small parts basket) and insert openings facing down and insert into the washer-
• Sort the instruments into the endo modules (step into the washer-disinfector, ensuring that the disinfector (using a securing net if necessary),
modules for manual instruments and FlexMaster/ instruments are not touching. ensuring that the instruments are not touching.
Mtwo modules for nickel-titanium instruments).
• Place the endo module in the black upper section
(manual instruments, Figure 1) or the blue lower
section (nickel-titanium instruments, Figure 2) of the
LavEndo box and close it (click into place).

Figure 1 Figure 2

Note: Preparation in the socket module is not

permitted.

• Insert the LavEndo box horizontally into the washer-

disinfector.
2. • Start the program.
3. After the program has finished, remove the • After the program has finished, remove the instruments from the washer-disinfector.
LavEndo box from the washer-disinfector.
4. • Check and package the instruments as soon as possible after removing them (see section “Checks, maintenance and packaging”), after leaving them to dry further in
a clean place if necessary.

An independent, accredited, recognised (Section 15 (5) • A disinfecting agent with verified effectiveness
MPG) test laboratory demonstrated the instruments’ intrinsic (e.g. VAH/DGHM approval, FDA clearance or CE mark) must
suitability for effective automated cleaning and disinfection be used and this must be compatible with the cleaning agent
using the G 7836 CD washer-disinfector (thermal disinfection, used;
Miele & Cie. GmbH & Co., Gütersloh) and the Neodisher
• The chemicals used must be compatible with the instruments
Medizym cleaning agent (Dr. Weigert, Hamburg). The laboratory
(see section “Important notes on material resistance”).
used the procedure described above to demonstrate this. The
Cidex OPA disinfecting agent and the Cidezyme cleaning agent Combined cleaning agents/disinfecting agents must not be
(both Johnson & Johnson GmbH, Norderstedt) were used for used.
pre-treatment.
The concentrations, temperatures and contact times specified
Manual cleaning and disinfection by the manufacturer of the cleaning agent and disinfecting
The following must be taken into account when selecting a agent as well as the minimum specifications for subsequent
cleaning agent and disinfecting agent: rinsing must be strictly adhered to. Only use freshly prepared
solutions, sterile or low-germ (< 10 CFU/ml) and low-endotoxin
• They must be suitable for cleaning and disinfecting (< 0.25 EU/ml) water (e.g. highly purified water HPW).
instruments;
• The cleaning agent, if applicable, must be suitable for
ultrasonic cleaning (no foaming);

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Re-Processing in Line with DIN EN ISO 17664/AAMI ST81

Procedure A: Procedure B: Procedure C:

Instruments that fit in the interim stand Instruments that do not fit in the interim stand Boxes and modules
(see Table 3) (see Table 3) (see Table 3)
1. • Sort the instruments, without stoppers, into the endo • Place the instruments in the cleaning bath in a • Place in a sufficiently large screen basket with the
modules (step modules for manual instruments sufficiently large screen basket for the prescribed openings facing down and insert into the ultrasonic
and FlexMaster/Mtwo modules for nickel-titanium contact time (with ultrasound assistance if bath filled with a sufficient amount of cleaning
instruments). necessary), ensuring that the instruments are solution for the prescribed contact time (but no less
• Place the endo module in the black upper section sufficiently covered but are not touching. than five minutes) and brush on the outside and
(manual instruments, Figure 3) or the blue lower • Then remove the screen basket from the cleaning particularly on the inside for at least one minute
section (nickel-titanium instruments, Figure 4) of the bath and rinse thoroughly with water at least 3 each (using a soft, clean brush; never use metal
LavEndo box and close it (click into place). x 1 min. brushes or wire wool).
• Then check that the instruments are not touching
and activate the ultrasound for the prescribed
contact time (but no less than five minutes).
• Then remove the screen basket from the cleaning
bath and rinse thoroughly with water at least 3
x 1 min.

Figure 3 Figure 4

Note: Preparation in the socket module is not

permitted.

• If present (see Table 3): Place new stoppers in a

small parts basket with a sufficiently small mesh
size.
• Insert the LavEndo box horizontally and, if present,
the small parts basket with the new stoppers into
the cleaning bath for the prescribed contact time,
ensuring that the instruments are sufficiently
covered (with ultrasound assistance if necessary).
• Then remove the LavEndo box and, if present,
the small parts basket with the stoppers from the
cleaning bath and rinse thoroughly with water at
least 3 x 1 min.
2. • Insert the LavEndo box horizontally and, if present, • Place in the disinfection bath in a sufficiently large • Place in the disinfection bath in a sufficiently large
the small parts basket with the new stoppers into screen basket for the prescribed contact time, screen basket for the prescribed contact time,
the disinfection bath for the prescribed contact ensuring that the instruments are sufficiently ensuring that the instruments are sufficiently
time, ensuring that the instruments are sufficiently covered but are not touching. covered but are not touching.
covered. • Then remove the screen basket from the disinfection • Then remove from the disinfection bath and rinse
• Then remove the LavEndo box and, if present, bath and rinse thoroughly with water at least 5 thoroughly with water at least 5 x 1 min.
the small parts basket with the stoppers from the x 1 min. • Dry by blowing them down fully with oil-free, filtered
disinfection bath and rinse thoroughly with water at • Dry the instruments by blowing them down fully compressed air (or medical compressed air from
least 5 x 1 min. with oil-free, filtered compressed air (or medical a can) and then leaving them to dry further in a
• Dry the LavEndo box and, if present, the small parts compressed air from a can) and then leaving them clean place.
basket with the stoppers by blowing them down fully to dry further in a clean place. • Check and package as soon as possible (see section
with oil-free, filtered compressed air (or medical • Check and package the instruments as soon as “Checks, maintenance and packaging”).
compressed air from a can) and then leaving them possible (see section “Checks, maintenance and
to dry further in a clean place. packaging”).
• Check and package the instruments as soon as
possible (see section “Checks, maintenance and
packaging”) and, if present (see Table 3), fit stoppers
to the instruments.
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Re-Processing in Line with DIN EN ISO 17664/AAMI ST81

An independent, accredited, recognised (section 15 (5) MPG) • compliance with DIN EN 11607/ANSI AAMI ISO 11607;
test laboratory demonstrated the instruments’ intrinsic
• suitable for steam sterilisation (withstands temperatures of up
suitability for effective manual cleaning and disinfection using
to 142 °C (288 °F) or more, sufficient vapour permeability).
the cleaning agent Cidezyme/Enzol and disinfecting agent Cidex
OPA (Johnson & Johnson GmbH, Norderstedt (Germany)). The
laboratory used the procedure described above to demonstrate
this. The Cidex OPA disinfecting agent and the Cidezyme
cleaning agent (both Johnson & Johnson GmbH, Norderstedt)
were used for pre-treatment.

Inspection
Open the LavEndo boxes and remove the step or FlexMaster/
Mtwo modules. Check all instruments, modules and LavEndo
boxes after cleaning/disinfection. Defective instruments, boxes
and modules should be immediately discarded.

These defects include:

• plastic deformation (e.g. caused by an excessively high

Figure 5
temperature during sterilisation);
• bent instrument; Warning: Sterilisation in the sterilisation trays without additional
packaging is not permitted. The autoclave paper in the boxes is
• untwisted threads;
for added safety only.
• damaged cutting surfaces;
• dull cutting blades; Sterilisation
• missing size marking;
Use only the sterilization methods listed below; other
• corrosion; sterilization methods are not permitted.
• discolouration.
Steam sterilisation:
Numerical restrictions on reuse are listed under “Reusability”. • Fractional vacuum/pre-vacuum method (at least three vacuum
Instruments that are still contaminated must be cleaned and cycles) or gravity displacement method1 with sufficient
disinfected again. product drying²;
• Steam steriliser in accordance with DIN EN 13060 or
Maintenance DIN EN 285, ANSI AAMI ST79;

Warning: Instrument lubricants must not be used. • Validated in accordance with DIN EN ISO 17665 (valid IQ and
OQ plus product-specific performance qualification (PQ));
Packing • Maximum sterilisation temperature of 138 °C (280 °F) must
not be exceeded; plus tolerance according to DIN EN ISO
Place the Step or FlexMaster/Mtwo module in the lower section 17665;
of the black sterilisation tray (Figure 5) and close it with the • See Table 1 for outside the USA, Table 2 for the USA only.
matching cover. Then package the sterilisation trays and
instruments that do not fit in the interim stand (see Table 3) into
disposable sterilisation pouches (disposable packaging) that
meets the following requirements:

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Re-Processing in Line with DIN EN ISO 17664/AAMI ST81

Minimum sterilisation time

Sterilisation procedure Sterilisation temperature
Exposure time at sterilisation temperature
Fractionated vacuum/ pre-vacuum method 134°C (273°F) 3 minutes³
Fractionated vacuum/ pre-vacuum method 121°C (250°F) 20 minutes
Gravity method 134°C (273°F) 5 minutes
Gravity method 121°C (250°F) 60 minutes
Table 1 (outside the USA)

Minimum sterilisation time

Sterilisation procedure Sterilisation temperature Exposure time at sterilisation Minimum drying time2
temperature
Fractionated vacuum/
132°C (270 F) 4 minutes 20 minutes
pre-vacuum method
Fractionated vacuum/
Not applicable at 121°C (250°F)
pre-vacuum method
Gravity method 132°C (270°F) 15 minutes 20 minutes
Gravity method 121°C (250°F) 60 minutes 20 minutes
Table 2 (USA)
1.
The less effective gravity method should only be used if the fractionated Important Information on material resistance
vacuum method is not available.

2.
The drying time that is actually required depends directly on parameters
When selecting cleaning and disinfecting agents, make sure
that are the sole responsibility of the user (loading configuration, how many that they do not contain any of the following substances:
items are loaded and how closely together they are loaded, condition of the
steriliser, etc.) and must therefore be established by the user. However, the -- Phenol;
drying time must never be less than 20 minutes.
-- Strong acids (ph <6) or strong alkalis (ph >8), neutral
3.
Or 18 min. (prion inactivation). enzymatic cleaning agent recommended;

Rapid sterilisation method (USA: Immediate-use steam -- Aldehydes;

sterilization) and the sterilisation method of unpackaged -- Anti-corrosive substances (especially di- or triethanolamine);
instruments (USA: Unwrapped sterilization) are not permitted.
-- Oxidants (hydrogen peroxide, sodium hypochlorite over 5%
Dry heat sterilisation, radiation sterilisation and sterilisation strength);
using formaldehyde, ethylene oxide or plasma are also not -- NiTi instruments may only be placed in oxidants (< 5%
permitted. strength sodium hypochlorite) for a maximum of 5 minutes;

An independent, accredited, recognised (Section 15 (5) -- Solvents;

MPG) test laboratory demonstrated the instruments’ intrinsic -- Oils:
suitability for effective steam sterilisation using the HST 6x6x6
Warning: Never clean the instruments, boxes, modules or the
steam steriliser (Zirbus Technology GmbH, Bad Grund) together
interim stand with metal brushes or wire wool.
with the fractionated vacuum method and the gravity method.
The laboratory used typical conditions found in clinics and
dental practices, as well as the procedure described above, to Never subject any instruments, boxes, modules or the interim
demonstrate this. stand to temperatures above 142°C (288°F). It is particularly
important to ensure that the products to be sterilised are not
Storage stored too close to the walls or floor of the steam steriliser (risk
of excessive temperature and deformation).
After sterilisation, instruments must be stored in the sterilisation
The blue foam insert for the interim stand must only be used
packaging and kept dry and dust-free.
once and must neither be cleaned/disinfected nor sterilised.
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Re-Processing in Line with DIN EN ISO 17664/AAMI ST81

Re-use Overview
Instruments can be reused several times – with proper care and Special/additional proced
if they are not damaged and contaminated;. See Table 3 below.
Each re-use or application of non-validated methods is the sole Product designation Material Manual cleaning/
responsibility of the user. Pre-treatment
disinfection

Certain applications may cause the instruments to prematurely

reach the end of their useful life. The maximum number of Procedure A after
Procedure A in
NiTi, silicone removing and
preparations will not always be reached. FlexMaster LavEndo box with
rubber disposing of the
FlexMaster module
stoppers
All liability is disclaimed for failure to follow these instructions or
use of non-validated methods for the re-use of instruments. Procedure A after
Procedure A in
NiTi, silicone removing and
Mtwo LavEndo box with
rubber disposing of the
Please always ensure that sterile packaging/wrapping is stoppers
Mtwo module
undamaged.
Procedure A after
Procedure A in
NiTi Finger Spreader, NiTi NiTi, silicone removing and
Disposal K-File rubber disposing of the
LavEndo box with
mini step module
stoppers
For proper disposal, always observe national laws and
K-Reamer, K-File, C-File,
recommendations of the authorities. Hedstroem File (up to
Procedure A after
Procedure A in
Stainless steel, removing and
and including a size of LavEndo box with
silicone rubber disposing of the
70), Flexicut Files, Finger mini step module
stoppers
Spreader, Finger Plugger
K-Reamer, K-File,
Hedstroem File (size 80 Procedure A in
and above), K-Reamer, Stainless steel Procedure A LavEndo box with
Hedstroem File for contra- mini step module
angle

Gates, Peeso, B-Reamer, Procedure A in

root filler, Beutelrock Stainless steel Procedure A LavEndo box with
enlarger mini step module

Stainless steel,
Procedure B in
MC instruments temperature- Procedure B
screen tray
resistant plastic
Stainless steel Procedure B in
Machtou Handplugger Procedure B
or NiTi screen tray
Temperature- Procedure B in
Minifix measuring gauge Procedure B
resistant plastic screen tray
Endo boxes, endo
modules, LavEndo box
(if preparation must take
Temperature-
place separately from Procedure C Procedure C
resistant plastic
instruments, particularly
in the case of heavy
contamination)

Procedure B after
Procedure B,
Temperature- removing and
Interim stand storage in screen
resistant plastic disposing of the
tray
foam disc

Procedure A in
Silicone stopper Silicone rubber Procedure A
small parts basket
Table 3

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Re-Processing in Line with DIN EN ISO 17664/AAMI ST81

dure for
Recommended
classification according
Automated cleaning/ Packaging for sterilisation Reusability to RKI/BfArM/KRINKO Notes
disinfection directive (Germany only,
intended use)

FlexMaster SystemBox/
Cleaned and undamaged instruments can be used up to eight times,
Procedure A in AccessoryBox/CombiBox
depending on the curvature of the canal.
LavEndo box with with autoclave paper and 8 Critical B
Please observe the product-specific directions for use.
e FlexMaster module single-use sterilisation
(See also www.vdw-dental.com)
packaging
Mtwo SystemBox with Cleaned and undamaged instruments can be used up to eight times,
Procedure A in
autoclave paper and depending on the curvature of the canal.
LavEndo box with 8 Critical B
single-use sterilisation Please observe the product-specific user manual.
Mtwo module
packaging (See also www.vdw-dental.com)
MiniBox, Basic Box,
Procedure A in SemiBox with step module
LavEndo box with with autoclave paper and 8 Critical B Depending on degree of wear.
mini step module single-use sterilisation
packaging
MiniBox, Basic Box,
Procedure A in SemiBox with step module
LavEndo box with with autoclave paper and 8 Critical B Cleaned and undamaged instruments can be used up to eight times.
mini step module single-use sterilisation
packaging
MiniBox, Basic Box,
Procedure A, SemiBox with step module
LavEndo box with with autoclave paper and 8 Critical A Cleaned and undamaged instruments can be used up to eight times.
mini step module single-use sterilisation
packaging
MiniBox, Basic Box,
Procedure A in SemiBox with step module
LavEndo box with with autoclave paper and 8 Critical A Cleaned and undamaged instruments can be used up to eight times.
mini step module single-use sterilisation
packaging

Procedure B in Single-use sterilisation

8 Critical A Cleaned and undamaged instruments can be used up to eight times.
screen tray packaging

Procedure B in Single-use sterilisation

8 Critical A Depending on degree of wear.
screen tray packaging
Procedure B in Single-use sterilisation If the specified sterilisation temperature and time are exceeded, this may
50 -
small parts box packaging result in plastic deformation.

If the specified sterilisation temperature and time are exceeded, this may
result in plastic cracks or deformation.
Single-use sterilisation
Procedure C 50 - Disassemble during pre-treatment, do not clean or disinfect when
packaging
assembled.

If the specified sterilisation temperature and time are exceeded, this may
result in plastic cracks or deformation.
Procedure B,
Single-use sterilisation Disassemble and dispose of the foam disc during pre-treatment, do not
storage in screen 50 -
packaging clean or disinfect when assembled. The new foam disc can be sterilised
tray
at the same time.

Procedure A, fitted See corresponding The stopper used must be removed during pre-treatment and replaced
Fitted to instrument 1
to instrument instrument. with a new stopper either before or after automated cleaning/disinfection.
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Re-Processing in Line with DIN EN ISO 17664/AAMI ST81

Products for single use only:

Possible damage/risks if
Instrument/product Material Special notes on cleaning/sterilisation Reusability maintenance instructions are not
followed

RECIPROC instruments Please consult respective Directions for Use (see also www.RECIPROC.com).

Instruments marked as “not sterile”

Stainless steel and only: One-off sterilisation before use. Proper removal of pulpal tissue
Barbed broaches temperature-resistant No cleaning/disinfection permitted. For single use only remnants from the barbs cannot
plastic Observe the instructions from the be guaranteed.
section “Packaging” onwards.

Disintegration of the foam if

Reprocessing not permitted.
used more than once; risk of
Foam discs for interim stand Foam Foam disc autoclavable once before For single use only
contamination from dried-on
single use.
residues.

Please consult respective Directions Risk of contamination,

Silver points Silver for Use For single use only deformation, attached sealer
(see also www.RECIPROC.com) remnants etc.

Risk of contamination,
Paper points Paper For single use only
deformation, loss of absorbance.

Guttapercha, zinc Risk of contamination,

Cold disinfection,
Guttapercha points oxide and barium For single use only deformation, adhesion of sealer
e.g. in med. alcohol
sulphate etc.

The stopper used must be removed

Proper cleaning of hole cannot be
Silicone stopper Silicone rubber during pre-treatment and replaced For single use only
guaranteed.
with a new stopper.

Risk of breakage if used

incorrectly; sterilisation alters the
EDDY Please consult respective Directions for Use (see also www.RECIPROC.com). material characteristics, thereby
discolouring the instrument and
making it porous.

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Instruction for the use of VDW instruments Part 2

For the protection of the patient’s airways we recommend to always work with a rubber dam!

1. Hand instruments
Indication for use: Root canal treatment
Contraindication: None known (short-term application)
Manufacturer: VDW GmbH
Instrument/product Application
K-Reamer Pushing/rotating motion (/reaming motion), max. 90° clockwise.
K-Files
Filing motion, max. 45° clockwise. Standard preparation methods, e.g. step back, step down, standardised method,
Flexicut Files
balanced force, etc.
C-PILOT Files
NiTi K-Files are for manual use only.
NiTi K-Files
Pushing and pulling motion without rotation. Rotating motion would cause the sharp blades to block.
Pushing and pulling motion without rotation. Rotating motion would cause the sharp blades to block. If the canal was
Hedstroem Files
enlarged with K-reamers, Flexicut or K-files, the following Hedstroem file should be one size smaller or equal.
MC instruments Pushing and pulling motion without rotation.
Barbed broaches (Exstirpation needles) Push into the canal and pull out following a rotating motion of approx. 180º.
Finger Spreader Lateral condensation of gutta-percha points. The spreader is placed between the points and pushed carefully in apical
NiTi Finger Spreader direction.
Finger Plugger Vertical condensation of gutta-percha points. Carefully condense the
Machtou Plugger gutta-percha points with the blunt instrument tip.

2. Instruments for use in the contra-angle

Indication for use: Root canal treatment
Contraindication: None known (short-term application)
Manufacturer: VDW GmbH

Pull on the instrument to check if it is firmly locked in the contra-angle. Note the instructions in the manufacturerer’s manual.

Instrument/product Application
Please consult respective Directions for Use.
Mtwo, FlexMaster
(also available at www.vdw-dental.com)
Please consult respective Directions for Use.
RECIPROC
(also available at www.vdw-dental.com)
K-Reamer Green contra-angle, max. 800 rpm.

Hedstroem files In yellow contra-angle only with 1/4 rotation, 450 – 800 rpm.
Green contra-angle, 450-800 rpm. High risk of perforation, therefore only to be used for the straight part of the canal.
Beutelrock reamer
Green contra-angle, to be used only for the straight part of the canal, due to high perforation risk.
Beutelrock enlarger Green contra-angle, 450-800 rpm. Use only to clear the canal access and to enlarge the coronal part.
Green contra-angle, 800-1,200 rpm
Peeso enlarger
To prepare the root canal access, to enlarge the coronal section and to create recesses for placing root posts.
Gates enlarger Green contra-angle, 800-1,200 rpm. To prepare the coronal part of the root canal before using files or K-reamers.
Green contra-angle. With the handpiece shut off, submerge root filler in filling material, insert root filler close to the apex,
Root canal filler type “L” and with max. 300 - 600 rpm rotate filling material into the canal whilst slowly withdrawing the instrument from the
canal.
Indication: adjustment of the working lenth of endo instruments, gutta-percha and paper points.
Contra-indications: none known.
Minifix measuring gauge Instruments: Place the stopper in the right-hand grove and adjust length by using the scale.
Gutta-percha points: Measure the length in the left recess and mark with notches on the point using tweezers.
Paper points: Measure the length in the left recess and mark with lateral creases.

These instructions are available in several languages upon request.

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Note:

VW000304 Rev. 7 / 28.03.17

VDW GmbH
Bayerwaldstr. 15 • 81737 Munich • Germany
R
Tel. +49 89 62734-0 • Fax +49 89 62734-304
www.vdw-dental.com • [email protected]