SHAVER SYSTEM
Ackermann
Page: 16 // 28
5.
Once the entire cycle is completed, remove the Handpiece from the washer /disinfector.
6.
Check the Handpiece to make sure that it is ready for use. Wrap immediately after removal from the washer /disinfector
(see chapter 6.3.5 Inspection/lubricants and 6.3.6 Packaging). If the Handpiece is still wet, dry at a clean place.
The suitability of these medical devices for effective mechanical cleaning and disinfection was tested and proved by an
independent test laboratory. A washer /disinfector G7735 CD (Co. Miele & Cie. KG, Gutersloh, Germany) and the detergent
Neodisher Mediclean forte (0.5 %)(Dr. Wiegert GmbH &Co. KG, Hamburg) were used. The above work flow was determined by
the tests in the test laboratory.
6.3. 4. MANUAl ClEANING AND DISINfECTION
Manual reprocessing (including ultrasonic bath) should only be chosen if mechanical reprocessing is not an option. Manual
cleaning and disinfection may only take place if the division/entity in charge is in possession of an officially approved
device and product specific process validation and if they are prepared to assume responsibility for the process.
When choosing the detergent, make sure that:
• it is suitable for cleaning medical devices with metal and plastic components,
• its suitability has been proved (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),
• all chemicals used are compatible with the present medical device (see chapter 6.3.9 material compatibility).
We recommend a combined solution for cleaning and disinfection, for example Korsolex plus (Co. Bode Chemie). The
concentration and immersion time specified by the manufacturers of the detergents and disinfectants have to be strictly
observed. Use sterile water, almost sterile water or water with a low content of Endotoxin (max. number of Endo-toxin
units: 0.25/ml) (e.g. processed water) only. The air used for drying must be filtered.
Work flow:
1.
Immerse the Handpiece in a bath filled with cleaning/disinfectant solution. Make sure that the Handpiece is in upright
position, with the receiving ring (20) facing downwards. The Handpiece and the cable must be completely covered with
cleaning solution. The valve control (21) must be in MAX position.
2.
During the immersion time, clean the lumina of the receiving ring and the suction channel several times with a brush of
matching diameter, whilst moving the valve control (21) back and forth.
3.
Lift the Handpiece out of the bath and rinse with sterile or almost sterile water for at least 10 minutes. Make sure that
the receiving ring (20) and the suction channel are completely free of residues of tissue and chemicals.
4.
Dry the Handpiece with filtered compressed air. Ensure that the receiving ring and the suction canal are free of any
residual moisture.
5.
Check the Handpiece to make sure that it is ready for use and wrap immediately (see chapter 6.3.5 Inspection/lubricants
and 6.3.6 Packaging). If the Handpiece is still wet, dry at a clean place.
6.3. 5. INSPECTION/lUBRICANTS
After cleaning and disinfection, remove the protective cap (27) from the plug (26) and check the Handpiece for corrosion,
damaged surfaces, spalling and visual contamination. Discard damaged Handpieces (see chapter 6.4 Reusability). In case
of residual contamination, repeat the complete cleaning and disinfecting process.
The inside of the Handpiece must not be moistened with any type of lubricant!
6.3. 6. PACkAGING
Place the protective cap (27) back onto the plug (22). The valve control (21) must be open (MAX position) when the Handpiece
is sterilized, which is why you have to ensure during wrapping that the valve control is in correct position. Loosely coil up
the cable of the Handpiece with a diameter of 30 cm. Wrap the Handpiece in disposable sterilization pouches (single or
double) and/or in a sterilization container, according to the following conditions:
• EN ISO 11607/ ANSI AAMI ISO 11607,
