SHAVER SYSTEM
Ackermann
Page: 14 // 28
In addition to the above, the country specific legal provisions regarding reprocessing of medical devices have to be
observed!
Safety precautions!
Always wear protective clothing during the reprocessing of contaminated medical instruments, i.e. eye and mouth
protectors, chemical-resistant gloves and moisture repellent clothes. Blood, residual tissues and other infectious
materials pose an increased risk of infection.
6.2. ClEANING AND DISINfECTION Of CONTROl UNIT AND fOOTSWITCh
Always make sure to remove the power cable from the plug and the power cable socket (15) on the rear panel of the Control
Unit prior to cleaning. During the cleaning process, the device must not be connected to the power supply in any way.
The Control Unit and the Footswitch must be cleaned and disinfected after every use. To remove dust and other dirt or
contamination use a clean cloth moistened with cleaning and disinfectant solution. Make sure that the cloth is just moist
and not soaking wet to prevent moisture from entering the sockets (2), (3) and (4) of the Control Unit.
When choosing the cleaning and disinfection solution, make sure:
• to use a product that is suitable for wet wipe disinfection of metal and plastic components,
• to choose a product 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), for example Microbac
forte, Velox AF or other.
• that the detergent is compatible with the disinfectant,
• that both agents are compatible with the Control Unit and its accessories (see chapter 6.3.9. material compatibility).
The concentration and immersion time indicated by the manufacturer of the detergents and disinfectants have to be
strictly observed.
6.3. ClEANING, DISINfECTION AND STERIlIzATION Of hANDPIECE
6.3. 1. GENERAl INfORMATION
Give preference to mechanical cleaning and disinfection of the Handpiece in the washer /disinfector. 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 they are prepared to assume responsibility for the process.
In both cases, pre-cleaning is absolutely essential!
Reusable instruments, such as shaver blades, must be reprocessed as indicated in the instruction pamphlet enclosed
with the instruments or according to the information provided by the manufacturer.
6.3. 2. PRE-ClEANING
Any visible contamination must be removed from the Handpiece immediately (within two hours at the very latest).
Procedure:
1.
When removing the Handpiece from the Control Unit, make sure to pull it out by holding the plug (26) and not by pulling
the cable. Seal plug with protective cap (27).
2.
Use a soft brush or a soft clean cloth with tap water or a disinfectant solution to remove any contamination from the
Handpiece. If using a disinfectant solution, make sure that this is free of aldehyde (risk of protein fixation) and suitable for
disinfecting the materials involved (see chapter 6.3.9 material compatibility). Choose a product 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).
3.
For pre-cleaning the inner lumina choose a brush with matching diameter. This applies to the suction channel and the
receiving ring (20). Move valve control (21) back and forth repeatedly during cleaning.
4.
Next, place the Handpiece into an ultrasonic bath filled with cleaning solution. Place the Handpiece in upright position,
