Coltene Diatech Gebrauchsinformation Seite 2

75305 11.19
Instructions for use
These Instructions for use and reprocessing apply to all DIATECH
diamond instruments used on patients.
Definition
DIATECH diamond instruments are rotary grinding instruments
for dentists, for the treatment of hard tooth substances, com-
posites, metals, ceramics and similar dental restorative materi-
als. DIATECH diamond instruments consist of a working part
with diamond grains in a galvanic nickel bond on a stainless
steel shaft.
Indications
• Preparation of cavities
• Preparation of crowns
• Removal of old fillings
• Fine adjustment
• Crown separation
• Endo-access
Contraindications
DIATECH diamond instruments contain small amounts of nickel.
The instruments should not be used in patients with a known
nickel allergy, as hypersensitivity may occur in extreme cases.

Safety Information
• Only supplied to dentists and dental laboratories or upon
their instructions.
• Wear safety glasses to protect eyes from emitted particles.
• Wear respiratory protection and use suction to prevent inha-
lation of aerosol and/or dust generated during application.
• The use of non-sterile diamond instruments increases the risk
of infection. The diamond instruments must be cleaned and
sterilised in accordance with the reprocessing instructions
below, before the first and each subsequent application.

• The use of blunt, damaged or no longer smooth-running dia-
mond instruments increases the risk of injury and can have a
negative effect on the work result.
• Tilting the diamond instrument and using the diamond in-
strument with a wedge or lever action can increase the risk of
breakage.
• The development of heat during preparation can lead to
damage of the tooth substance, pulp and adjacent fillings.
• Exceeding the maximum specified speed may result in exces-
sive heat generation and/or damage to the diamond instru-
ment.
• The use of diamond instruments with excessive contact pres-
sure can lead to excessive heat development and/or damage
to the diamond instrument.
• The use of a technically faulty handpiece increases the risk of
injury and can have a negative effect on the work result.
• Dental material or other residues that are detached during
application can be aspirated or swallowed.
Application
• Only use technically and hygienically perfect handpieces and
diamond instruments. Diamond instruments with blank areas
on the working part as well as blunt, damaged, bent or no
longer smooth-running diamond instruments must be sorted
out immediately and disposed of properly.
• Use a rubber dam to prevent aspiration or swallowing.
• The diamond instruments have to be selected (shape, size,
type) primarily according to the type of preparation.
• Diamond instruments with coarse grain are suitable for gross
reduction. Diamond instruments with fine grain are suitable
for fine finishing.
• Secure the diamond instruments carefully and completely in-
to the handpiece.
• Check that the diamond instrument is securely connected to
the handpiece.
• Before applying the diamond instrument to the preparation
site, bring it up to working speed. Ensure that the instrument
rotates without unbalance and that the water cooling func-
tions properly.
• Place the diamond instrument rotating at working speed on
the preparation site and begin with preparation. The ergo-
nomic principles must be taken into account during the
working procedures. Do not use the instrument with a wedge
or lever action. Once the preparation has been completed, re-
move the rotary instrument from the site and allow it to
come to a standstill.
• During use, move the diamond instrument continuously and
use with sufficient water cooling (min. 50ml/min).
• Use speeds as indicated on the packaging label.
• The recommended force applied (reference value 1.5 N) is
based upon the diameter of the diamond instrument and the
substrate to be worked on.
Storage
Diamond instruments should be stored in a dry environment.
DIATECH Diamond grinding instruments for the dental practice
Whenever possible, the diamond instruments should be stored
in their original packaging to enable them to be identified and
traced.
Marking:

The number is shown on the package label.
REPROCESSING INSTRUCTIONS
The instructions given below were validated by the manufac-
turer of the medical device as being suitable for the preparation
of a medical device for its reprocessing. The reprocessor is re-
sponsible for ensuring that the actual reprocessing with the
equipment, materials and personnel employed in the reprocess-
ing plant delivers the desired results. This requires verification
and/or validation and routine monitoring of the process.
Safety instructions

• DIATECH diamond instruments are supplied non-sterile and
must be reprocessed before the first and each further use.
• If not cleaned and sterilised properly, there is a risk of infec-
tion.
• Protective clothing, gloves and goggles must be worn at all
times during reprocessing.
• Only use a cleaning agent/disinfectant suitable for diamond
instruments.
• Strongly acidic and alkaline cleaning agents can lead to im-
pairment of the diamond instruments. It is recommended to
use pH neutral detergents.
• Simple cold disinfectant solutions are unsuitable for repro-
cessing. Such solutions do not result in sufficient sterility and
may contain corrosive substances that reduce the perfor-
mance and resistance of the diamond instrument.
• Use a cleaning agent containing a corrosion inhibitor.
• The cleaning agent manufacturer's instructions must be fol-
lowed.
• Use sterilizing devices according to the manufacturers rec-
ommended procedure.
• It is the responsibility of the user to ensure that sterilisation is
effective.
Reprocessing limitations
Repeated reprocessing has a minimal effect on the diamond in-
struments.
The end of use is determined by the wear and damage of the
diamond instrument during its use. Diamond instruments must
be checked for wear and damage before each use.
INSTRUCTIONS
Initial treatment at the site of use
Remove surface contamination immediately after use on the pa-
tient using a disposable cloth, then place diamond instruments
in container.
Storage and transport:
Transport diamond instruments in a closed container to the re-
processing site immediately. Start cleaning immediately.
 The drying of impurities makes cleaning of diamond instru-
ments more difficult.
Ultrasonic cleaning
1. For pre-cleaning, place diamond instruments in a bath with a
suitable enzymatic cleaning agent (e.g. BioSonic UC32, man-
ufactured by Coltène/Whaledent Inc., contact time: 5 min-
utes). Ensure that the diamond instruments are completely
covered by the cleaning agent and do not come into contact
with each other.
2. Remove remaining impurities with a soft brush.
Special attention must be taken to ensure that difficult-to-

access areas of the diamond instruments are cleaned and
that spreading of germs through spraying is prevented.
3. Remove the diamond instruments from the cleaning agent
and rinse with cold water for 2 minutes.
4. Dry the diamond instruments with a fibre-free cloth.
5. Fill the ultrasonic device with a suitable enzymatic cleaning
agent (e.g. BioSonic UC32, manufactured by Coltène/
Whaledent Inc.).
6. To avoid damage, insert the diamond instruments into a suit-
able instrument holder and place in the ultrasonic device.
7. Treat the diamond instruments in an ultrasonic bath for 10
minutes.
8. Remove the diamond instruments from the ultrasonic device
at the end of the program and rinse under cold water for 2
minutes.
Drying
Dry the diamond instruments with a fibre-free cloth.
Maintenance, inspection and testing
Visual inspection for cleanliness and integrity, using magnifica-
tion if necessary. In case of visible contamination, the process
must be repeated. Damaged or rusting diamond instruments
must be disposed of.
 Diamond instruments cannot be properly sterilised unless
they have been thoroughly cleaned and are free from contami-
nation.
Packaging for sterilisation
Pack diamond instruments in bags which have been validated
for sterilisation (e.g. self-adhesive bags from SPSmedical).
Sterilisation
Diamond instruments can be sterilised by applying a sterilisa-
tion cycle with dynamic air removal. Sterilise in a bag at full cycle
with a minimum holding time of 3 minutes at 132 °C (270 °F).
 DIATECH diamond instruments are not suitable for sterilisa-
tion with hot air or in chemiclaves, as these reprocessing meth-
ods have not been validated.
Storage
Store the diamond instrument in the sterilisation bag until use.
Recommended Speeds
Head diameter in
1/10 mm
007-011
012-015
016-019
021-023
024-028
029-032
033-041
042-054
055-060
Manufacturer Contact:
Coltène/Whaledent AG
Feldwiesenstrasse 20
9450 Altstätten / Switzerland
T +41 71 757 5300
F +41 71 757 5301
info.ch@coltene.com
Date of issue: 11-2019
Keep out of the reach of children.
EN
Speed range
(r.p.m.)
75.000-150.000
60.000-110.000
45.000-88.000
40.000-75.000
30.000-65.000
25.000-56.000
22.000-45.000
20.000-37.000
17.000-32.000