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Information
on Use
General Information
Please
make sure the instrument is suitable for the intended use.
Preparation Before First
Use
Before
the first use an instrument must be cleaned thoroughly, tested, and
sterilized, i.e. it must be subjected to the same reprocessing procedure
as an instrument after the operation. Please make sure the instrument has
not been damaged in transit or storage.
Instruments
may only be reprocessed by personnel who have undergone the relevant
training. The recommendations issued by the German Commission for Hospital
Hygiene and Infection Prevention at the Robert Koch Institute (RKI)
concerning "Hygiene Requirements for the Reprocessing of Medical
Devices" must be observed. We assume that trained personnel will have
knowledge of these recommendations.
Reprocessing of Instruments
According
to EN/ISO 17664 the manufacturer of medical devices is obliged to draw
attention to at least one method of cleaning by machine. The
process of cleaning by machine explained below was validated in a Miele GD
7735CD with the chemical Deconex 28 AlkaOne (Borer, Zugwil/Switzerland)
using the radioisotope method.
Of
course other detergents and machines can also be used for reprocessing. In
such cases ask your chemical supplier or machine manufacturer whether
their products are just as effective as the products with which the method
was validated.
Reprocessing Instructions
1. Preliminary Cleaning
Manual Preliminary Cleaning
Rinse
all the instruments carefully using warm water as soon as the operation
has been completed. Remove any stubborn deposits with a cotton swab. Use
soft cleaning brushes for cavities. Rinse out cannulas with a water jet
(1.8 bar) for 5 sec. Never use metal brushes or scouring powder. Dismantle
take-apart instruments. In the case of forceps, clamps and other
instruments with a locking mechanism open the lock.
Ultrasonic Cleaning
As
an alternative to or in addition to manual cleaning you can soak the
instruments in an ultrasonic cleaning bath for 5 minutes. We recommend
ultrasonic cleaning systems with a frequency of at least 40 kHz.
Rinsing and Drying
After
cleaning, rinse with purified water (Aqua purificata). Allow the water to
drain off properly. Dry carefully with soft cloths or sponges.
2. Cleaning by Machine
(cleaning cycle with
chemical/thermal disinfection).
Place
the instruments in suitable holders in the washing machine in accordance
with the operating instructions issued by the washing machine manufacturer
(Miele). Connect cannulas up to the special nozzles.
Run the following cleaning cycle:
4
min Pre-wash with cold water
6
min Clean at 70°C, deconex 28 Alka One 0.5% (Borer Zuchwil)
3
min Neutralize with warm water (>40°C).
2
min Rinse with warm water (>40°C)
Dry
Functional Test
Determination
of pH with indicator paper for at least one instrument per cycle.
Functional
test in accordance with Miele's operating instructions.
Visual
examination for cleanliness.
Check
the instruments for loose parts, cracks, rust, and function.
In
the case of scissors, hemostats, and other instruments with joints,
lubricate the joints with a suitable oil or grease (available from us).
Packaging
Use
suitable packaging for sterilization. (Either use transparent sterile
packaging or a suitable sterilization box (observe the instructions for
use issued by the manufacturer of the sterilization box).
Sterilization
We
recommend that our instruments be sterilized in an autoclave at 134° C.
Observe the operating instructions for the autoclave and the DIN 58946
standard. Flash sterilization is not permitted for instruments with a
lumen.
Storage
Store
the sterilized instruments in a dry, clean, and dust-free environment at
moderate temperatures.
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CARL
TEUFEL GMBH & CO.
KG
Medical
Device Manufacturing
Tuttlinger
Str. 30
D-78576
Liptingen, Germany
Telephone
+49(0)7465 1022
Fax +49(0)7465 1024
E-mail:
office@carl-teufel.de