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Ackermann
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SHAVER SYSTEM
with the receiving ring (20) facing downwards. The Handpiece and the cable must be completely covered by cleaning
solution. The valve control (21) must be set in MAX position, when choosing the cleaning solution, make sure that:
• the solution is suitable for cleaning instruments with metal and plastic components,
• all chemicals contained in the solution are compatible with the medical devices (see chapter 6.3.9 material
compatibility),
• the solution is suitable for ultrasonic baths (i.e. no foaming).
5.
Rinse the entire Handpiece. Rinse all lumina, e.g. the suction channel and the closing mechanism of the receiving ring
with a water pistol with cold water for at least 10 seconds (static water pressure: 3.8 bar). Make sure that the valve control
(21) is in MAX position to prevent any contamination from remaining in the receiving ring or in the suction channel.
Please note that the above pre-cleaning process and the cleaning agents used (see point 2 and 3) merely serve to protect
the person carrying out the reprocessing procedure. This does not in any way replace the disinfection cycle which is
absolutely essential.
For manual removal of contamination (see point 2 and 3), only use soft brushes and soft clean clothes that are intended
for this purpose. The use of metal brushes and steel wool is not permitted as these would damage the surface. Take great
care when cleaning the Handpiece, especially when cleaning the lumina in the receiving ring and the suction channel (see
point 3 and 5). In absence of an ultrasonic bath (see point 4), an ordinary bath is acceptable in exceptional cases, in which
case a minimum immersion time of 20 minutes must be observed.
The suitability of these medical devices for effective pre-cleaning was tested and proved by an independent test laboratory.
The detergent Neodisher Mediclean forte (0.5 %) (Dr. Wiegert GmbH & Co. KG, Hamburg) was used. The above work flow was
determined by the tests in the test laboratory.
6.3. 3. MEChANICAl ClEANING AND DISINfECTION
When choosing the washer / disinfector, make sure that:
• the suitability of the washer/disinfector has been proven (e.g. authorized by the FDA or provided with a CE mark pursuant
to DIN EN ISO 15883),
• a program for thermal disinfection is available (Ao value> 3000 or - in older devices - a minimum hold time of 5 minutes at
90°C). A chemical disinfection involves the risk of residues being left on the Handpiece,
• the program is suitable for these medical devices and that it comprises a sufficient number of rinsing cycles,
• the final rinse is done with sterile water, almost sterile water or water with a low content of Endotoxin (max. number of
Endotoxin units: 0,25/ml) (e.g. processed water),
• the air used for drying is filtered,
• the washer / disinfector is serviced and checked in regular intervals.
When choosing the detergent, make sure that:
• it is suitable for cleaning medical devices with metal and plastic components,
• if thermal disinfection is not an option, a suitable disinfectant with proven suitability (e.g. approved by the German
Association for Hygiene and Microbiology (DGHM) or the Association for Applied Hygiene (VAH), authorized by the FDA or
provided with a CE mark) must be used. The disinfectant must be compatible with the detergent,
• all chemicals used during the process must be compatible with the present medical devices (see chapter 6.3.9 material
compatibility).
The concentrations specified by the manufacturers of the detergents and disinfectants have to be strictly observed.
Work flow:
1.
Loosely coil up the cable of the Handpiece with a diameter of 30 cm.
2.
Immerse the Handpiece in the washer /disinfector. Make sure that the Handpiece does not touch any other instruments
and that the receiving ring (20) is facing downwards. It can be placed in vertical or diagonal position.
3.
The aspiration port (23) of the suction channel must be connected to a flexible tube at the basket. Make sure that the
valve control (21) is in MAX position.
4.
Start the program.