Komet F360 Fill Gebrauchsanweisung Seite 6

use of a blunt plastic instrument.
The main part of the oven may be wiped with a slightly damp cloth,
using standard cleaning solutions and surface disinfection products.
Sterilization guide for the removable top part
WARNINGS Discharge damaged products
Limitations on
reprocessing 250 cycles
INSTRUCTIONS
Point of use Remove excess soil with
disposable cloth/paper tissue
Preparation for
decontamination No specifi c requirements
Cleaning: Automated Not recommended
Cleaning: Manual Equipment: Detergent, brush, distilled or
demineralised water
1. Rinse excess soil from cover
2. Using brush, apply detergent solution to
all surfaces
3. Rinse under clear running water
Disinfection Not recommended
Drying Do not exceed 134º C
Maintenance, inspection
and testing Discharge damaged products
Packaging Only pack individually
Sterilization Vacuum autoclave, minimum 18 minutes
at 134º C, pressure 2.2 bar
Do not exceed 134º C
Storage No particular requirements
4. Labelling
?
Consult instructions
Serial number
Medical Electrical Equipment Directive, DS/EN 60601-1:
2006 Electric shock protection, Type B
-
Medical device, Directive MDD
MDD Directive 93/42/EEL
Medical device, class I
Waste Electrical and Electronic Equipment Directive,
WEEE Directive 2002/96/EC
Please return the product for recycling.
F360 Fill obturators
Classifi cation
The F360 Fill obturator is a medical device; class IIA,
in compliance with MDD (Medical Devices Directive) section IX.
The obturator must only be used by dentists. Read and follow the
instructions carefully!
General precautions
- The product should only be used by dentists.
- The product should only be used for root canal procedures in teeth.
- A deformed or defective product should never be used, but should be
discarded.
- It is the responsibility of the user to check the products prior to use
to ensure that they are suited for the intended purpose. The operator is
responsible for the correct use of the instruments. In case of contribu-
tory negligence by the user. Gebr. Brasseler partially or totally declines
liability for all resulting damages, particularly due to the non-obser-
vance of our recommendations for use or warnings as well as inadvert-
ent misuse by the user. For information on the correct use of the prod-
uct, please see the step-by-step guide, section 2.
- The product should be stored in the original packing.
Warnings - obturator
- After heating, the gutta-percha is hot. Avoid any direct contact
between the obturator and skin or mucous membranes. The obturator
should be inserted directly into the root canal.
- It is always recommended to take a control x-ray. If the x-ray is not
satisfactory, take another x-ray from a diff erent angle. If the fi lling still
cannot be satisfactorily documented, remove the obturator.
1. Description of the F360 Fill obturator
1. Description of the F360 Fill obturator
A F360 Fill obturator is a carrier of biocompatible plastic, which is A F360 Fill obturator is a carrier of biocompatible plastic, which is
coated with thermoplastic gutta-percha. The sizes are 20 to 60 accord-
ing to ISO standard. The obturator sizes correspond to the ISO stand-
ards of root canal fi les. A single obturator is all that is needed to fully
obturate a root canal. The result should always be a perfectly placed
root canal fi lling with a tight apical seal.
A F360 Fill obturator consists of three parts:
1. Plastic handle with a metal insertion pin
The plastic handle is color-coded according to the size of the obturator.
The stainless steel insertion pin is 9 mm long and permanently
attached to the plastic handle. The metal insertion pin is placed 6 mm
down in the plastic carrier. When the metal insertion pin is removed it
will leave a hollow part of 6 mm in the plastic carrier.
2. Outer layer of thermoplastic Natural GP™ gutta-percha
The gutta-percha is reversible thermoplastic. This means that it becomes
soft and highly adhesive when heated to temperatures above approx.
100°C. When cooled, it returns to its original fi rm, rigid state. Another
heating will once again make the gutta-percha soft and adhesive.
3. Plastic carrier with endo stop
The tapered plastic carrier is suffi ciently fl exible to negotiate curved
canals.
The F360 Fill plastic carrier is slightly tapered. This insures adequate
back fl ow of the heated gutta-percha. The length of the carrier is 24
mm. The 6 mm coronal portion of the carrier is hollow to accommo-
date the metal insertion pin. A rubber endo stop is provided to indicate
the working distance measurement. The plastic carrier and gutta-
percha are radiopaque.
2. A step-by-step guide
Before using the F360 Fill obturator, assure that you have achieved the
following:
- A properly cleaned and shaped canal – the key to any successful root
canal fi lling. Utilize any technique which provides a smooth tapered
form and coronal access wide enough to give room for the instruments.
- A dry root canal.
- An established working length. The plastic carrier is fl exible enough to
negotiate curved canals. It is highly advised that rotary fi les with a
higher conicity are utilized to create a suffi cient taper for the obturator.
When using fi les with a conicity of 2 %, it is advised to combine them
with a procedure using Gates Glidden Drills or similar fi les which can
be used to create a suffi cient opening in the coronal part of the canal.
The use of size verifi ers is recommended.
STEP 1: Determine the working length and choose the proper
obturator size
The working length is measured all the way to the apex (B1). We rec-
ommend measuring the working length from the edge of the cusp. The
working length may be determined by use of x-ray, fi le and electronic
apex locator. Generally, the appropriate size F360 Fill obturator will be
the same size as the last fi le used at the apex of the canal. TIP: For
very narrow and/or highly calcifi ed canals, it may be useful to select
one size smaller than the last fi le used at the apex. If you do not use
rotary fi les with a taper of 4% or more, you should always verify the size
of the cleaned root canal with a size verifi er before inserting the obturator.
Mark your working length on your F360 Fill obturator.
When the size verifi er has a slightly loose fi t in the apical third of the
root canal, the rubber stop is placed at the working length. Afterwards,
the working length is transferred to the obturator.
STEP 2: Heating of the obturator
Place the selected obturator in the F360 Fill oven and activate it (B2,
B3). See above for more detailed information on the appropriate use of
the oven.
STEP 3: Application of sealer
While the obturator is heating, mix any heat resistant sealer (usually a
non-eugenol sealer) with long working time, e.g. Komet EasySeal,
9978. Make sure that the root canal is completely dry before applying
sealer.