M3-Safe Path Files

FOR DENTAL USE ONLY

Instruction for use

0) COMPOSITION
The cutting part of these instruments is made of a nickel-titanium alloy.

1) INDICATIONS FOR USE

Applications: catheterization of the root canal.These instruments are to be used only in a clinical
or hospital environment, by qualified users.
Users are responsible for checking whether the product can be used for the purpose intended.

2) CONTRAINDICATIONS
None known

3) WARNINGS
This product contains Nickel and should not be used for individuals with known allergic sensitivity
to this metal.
In order to prevent infectious agent transfer it is highly recommended to use a rubber dam
system during the endodontic procedure.

4) PRECAUTIONS

 Multiple use and re-processing cycles may lead to increased risk of file separation.
 These instruments should not continuously be immersed in a sodium hypochlorite solution.
 Instrument decontamination (Only applicable for the non-sterile version of the instruments):
strictly follow decontamination instructions from the manufacturer.
 Irrigate abundantly and frequently.
 Before using the M3-Safe Path Files, establish a glide path using hand files, to at least an ISO
size 010.
 Use at constant rotation at a speed of 300 rpm.
 Clean flutes frequently and check for signs of distortion or wear.
 Use the Files with light pressure.
 Use the files to follow the canal to the working length, and then withdraw.

5) ADVERSE REACTIONS
In the present technical state, no adverse reaction has been reported to date.

6) STEP BY STEP INSTRUCTIONS FOR M3-Safe Path Files

1) Establish a manual Glide Path with standard stainless steel K-File # 008, # 010.
2) Identify the working length with the #010 K-File in combination with an Apex Locator.
3) Irigate.
4) Use the M3-Safe Path Files #013 (P1) to working length.
5) Irrigate.
6) Use the M3-Safe Path # 016 (P2) to working length.
7) Irrigate.
8) Use the M3-Safe Path #019 (P3) to working length
9) Irrigate.
10) Before starting the canal shaping with M3 shaping files, confirm your working ength with a
K-File #015 combined with an Apex Locator.

7) DISINFECTION, CLEANING AND STERILIZATION

Reprocessing procedure for dental instruments.
For those devices that are not labelled “single use”, re-processing of the devices should be carried
out as per this IFU. For hygiene and sanitary safety purposes, these instruments must be cleaned
and sterilized before each re-use to prevent any contamination.
Excluded devices:
Uniclip and Mooser Calcinable plastic posts cannot be sterilized and must be disinfected by
immersion NaOCl (2,5 % at least) during 5 min. at ambient temperature.
GENERAL RECOMMENDATION:
1) Use only a detergent solution, with disinfecting effect, which is approved for its efficacy
(VAH/DGHM-listing, CE marking, FDA approval) and in accordance with the IFU of the detergent
solution manufacturer. For all metal devices, it is recommended to use anticorrosion disinfecting
and cleaning agents.
2) For your own safety, please wear personal protective equipment (gloves, glasses, mask).
3) The user is responsible for the sterilization or disinfection of the product for the first cycle and
each further usage as well as for the usage of damaged or dirty devices where applicable after
sterilization.
4) It is safest for the practitioner to use our devices only once. Should our devices be reused, we
recommend that they should not be used more than 5 times. After each processing they should
be carefully inspected before use: the appearance of defects such as deformations (bent,
unwound), breakage, corrosion, loss of colour coding or marking, indicate that the devices are
not able to fulfil the intended use with the required safety level and must therefore be discarded.

For our root canal shaping instruments we recommend not to exceed the following maximum
number of uses:
Type of canal Stainless Steel Stainless Steel NiTi instruments
Instruments with a Instruments with a
diameter ≤ISO 015 diameter >ISO 015

Extremely curved 1 canal max. 2 canals max. 2 canals max.

(>30°) or S-shaped
canals
Moderately curved 1 canal max. 4 canals max. 4 canals max.
canals (10° to 30°)
Slightly curved 1 canal max. 8 canals max. 8 canals max.
(<10°) or straight
canals

5) Single use marked devices are not approved for re-use.

6) For the final rinsing step deionised water use is mandatory, whether using an automated
washerdisinfector or a manual cleaning method. Tap water is permissible for the other rinsing
steps.
7) Instruments with plastic handles, and NiTi instruments should not be used with Hydrogen
Peroxide solution which is known to degrade them.
8) Only the active part of the NiTi instrument, which is in contact with the patient should be
immersed in a NaOCl solution concentrate at NOT more than 5%.
9) Avoid device to dry out, prior to, or during pre-disinfection, or cleaning. Dried biological
material can be difficult to remove.
10) Use only device appropriated support for reprocessing.
11) Do not use label systems or identification markers directly on the device.

8) STEP-BY-STEP INSTRUCTIONS

STEP-BY-STEP INSTRUCTIONS

Instruction A
Operation Activities Warning and remarks
1 Disassemblin -Disassemble the device, if -Remove and discard silicone stops.
g applicable.
2 Pre-Disinfecti -Soak all devices -Follow instructions and respect
on immediately after use in a concentrations and immersion times given
disinfection solution. Use a by the manufacturer (an excessive
tray made from high concentration may cause corrosion or others
density polyethylene or defects on devices).
stainless steel. -The pre-disinfection solution should be a
specific solution targeted by the supplier for
pre-disinfection. It should be used at the
dilution specified by the supplier. It should
contain, or be combined with a proteolytic
enzyme.
-The pre-disinfection solution should be
aldehyde free (to avoid blood impurities
fixation) and without di- or triethanolamines
 as corrosion inhibitor. Change the
pre-disinfection solution regularly i.e. When
it becomes soiled, or when efficacy is
diminished due to exposure to microbial
loads.
-Do not use pre-disinfecting solutions
containing Phenol or any products, which
are not compatible with the devices(See
general recommendations).
-For visible impurities observed on
instruments a pre-cleaning is recommended
with a soft brush (made from either nylon,
polypropylene, acrylic). Manually brush the
device until visible impurities are removed.
3 Rinsing - Abundant rinsing (at least -Use tap water for rinsing.
1 min) under running -If a pre-disinfectant solution contains a
water (ambient corrosion inhibitor, it is recommended to do
temperature). the rinsing step just before starting the
cleaning step
4 Automated - Place the devices in a kit, -Discard any devices with large obvious
Cleaning with support, or container defects (broken, bent,…).
washer- (made from stainless steel -Avoid any contact between instruments or
disinfector or titanium) to avoid any posts when placing in the washer
contact between devices disinfector use kits, supports or containers.
or posts. -Follow instructions and concentrations
-Place the devices in the given by the manufacturer of the detergent
washerdisinfector and solution(see also general
execute the defined cycle recommendations).
(Ao value > 3000 or, at -Follow the instructions of the
least 5 min at 90°C). washer-disinfector and verify the success
-Use a detergent solution criteria after each cycle have been met as
with cleaning properties stated by the manufacturer.
-The final rinse step should be with
deionised water. For other steps follow the
water quality defined by the manufacturer
-Use only approved washer-disinfector
according to EN ISO 15883, maintained and
validated regularly.
-It is recommended to use an alkaline
detergent with tensides, which has grease
removal, disinfection (against bacteria/
fungi) and corrosion inhibition properties.
The detergent should be approved for its
efficacy (VAH/DGHM-listing, CE marking,
 FDA approval) and used in accordance with
its IFU The detergent should be aldehyde
free and without di- or triethanolamines as
corrosion inhibitor.

Instruction B
1 Manual -Place the devices in a kit, -No visible impurities should be observed on
Cleaning support or container the devices.
assisted by an (made from stainless steel, -If visible impurities are observed on the
ultrasonic polypropylene or titanium) devices, the device must be manually
device to avoid any contact brushed t with a soft brush (made from
between devices. either nylon, polypropylene, acrylic) until
-Immerse in the detergent visible impurities are removed.
solution with cleaning -Discard any devices with large obvious
properties. defects (broken, bent, and unwound).
-Follow instructions, observe water quality,
concentrations and cleaning time stated by
the manufacturer of the cleaning solution
(see also general recommendations).
-It is recommended to use an alkaline
detergent with tensides, which has grease
removal, disinfection (against bacteria/
fungi) and corrosion inhibition properties.
The detergent should be approved for its
efficacy (VAH/DGHM-listing, CE marking,
FDA approval) and used in accordance with
the IFU of the detergent solution
manufacturer).
-The detergent should be aldehyde free and
without di- or triethanolamines as corrosion
inhibitor.
2 Rinsing -Abundant rinsing (at least -Use deionised water for rinsing.
1 min) under running -If the previously used cleaning solution
water (ambient contains a corrosion inhibitor, it is
temperature). recommended to do the rinsing step just
before starting the autoclaving.

3 Drying - Devices should be -Dry on a single use non-woven cloth, or

thoroughly dried before with a hot air drier at not more than 110°C.
inspection and packaging. -Devices should be dried until visual traces
of moisture are eliminated
-Particular attention has to be paid to
effectively dry joints or cavities within a
device
4 Inspection -If applicable assemble the -Dirty devices must be cleaned again.
devices (including the -Do not re-use silicon stops.
placement of new silicon -Discard devices, which show any defect as
stops). described in the General Recommendation
-Inspect the devices above .
functionality.
-Inspect devices and sort
out those with defects.

5 Packaging -Place the devices in a kit, -Use packaging which are resistant up to a
support or container to temperature of 141°C (286°F) and in
avoid any contact between accordance with EN ISO 11607. -Avoid any
instruments or posts and contact between instruments or posts
pack the devices in during sterilization. Use kits, supports or
“Serialization pouches”. containers.
-For sharp devices that are not contained
within a box, silicon tubes should be placed
around the devices to prevent packaging
piercing.
-Seal the pouches according to the
recommendation of the pouch
manufacturer. If a thermo-sealer is used, the
process must be validated.
-Check the validity period of the pouch
given by the pouch manufacturer to
determine the shelf life.

6 Sterilization - Steam sterilisation at -The instruments and posts must be

134°C / 273°F during 18 sterilized according to the packaging
min is recommended for labelling.
these devices, for the -Place the pouches in the steam steriliser
purpose of de- activating according to the recommendation given by
 potential prions. the steriliser manufacturer.
-Use only steam steriliser that are matching
the requirements of EN 13060 (class B, small
steriliser), EN 285 (full size steriliser).
-Use a validated sterilisation procedure
according to ISO 17665 with a minimum
drying time of 20 min.
-Respect the maintenance procedure of the
steriliser given by the steriliser
manufacturer.
-Control the efficiency and acceptance
criteria of the sterilisation procedure
(packaging integrity, no humidity, no colour
change of packaging, positive
physico-chemical indicators, conformity of
actual cycle parameters, to reference cycle
parameters).
-Store traceability records and define
shelf-life according to packaging
manufacturer guidelines.
-Shorter sterilisation cycles according to
local regulations are possible but are not
guaranteed to de-activate prions.

7 Storage -Keep devices in -Sterility cannot be guaranteed if packaging

sterilization packaging in a is open, damaged or wet.
clean environment, away -Check the packaging and the medical
from sources of moisture devices before using them (packaging
and direct sunlight. Store integrity, no humidity and use by date).
at ambient temperature.

Manufacturer EC REP

United Dental Changzhou

Add:Buliding,B1,No.9 Prolinx GmbH

Changyang road,Wujin District, Brehmstr. 56, 40239, Duesseldorf,

Changzhou, Jiangsu Province Germany

213145,China.
www.udg-dental.com