1 User considerations
Thermo Scientific
5
50112712_082007_GB
1 User
considerations
This operating manual is directed at users and operators (or their representatives) of
VARIOKLAV Type 65 TC benchtop steam sterilizers. It deals with personal safety
and sterilization reliability and quality.
DANGER
The VARIOKLAV Type 65 TC benchtop sterilizer must only be
operated by skilled or semi-skilled personnel able to ensure its
proper operation. In Germany, its use is subject to the
Regulation for the Operation of Medical Devices
(Medizinprodukte-Betreiberverordnung – MPBetreibV –) of
June 1998.
This audience consists of three target groups:
Target group 1:
Skilled hospital hygiene and sterilization staff
Target group 2:
Semi-skilled hospital hygiene and sterilization staff
Target group 3:
Service technicians skilled for medical units
Operators and target groups 1 and 3 should read the entire operating manual and
its supplements. Chapters 1 through 10 are directed at target group 2.
Correct use
INFORMATION
Thermo will only release load samples in accordance with the
validation documentation as available to the persons
responsible for supply matters.
The VARIOKLAV Type 65 TC benchtop sterilizer is a Class IIa medical device
pursuant to EU Guideline 93/42/EEC. The sterilizer is intended for use in a clinical
environment. Prior to sterilization, all items must be thoroughly cleaned and
disinfected. The items to be sterilized must be packaged in accordance with their
intended use. Sterile packaging must conform to all applicable EN and national
standards. Packaged hollow, solid, or porous items may be sterilized.
The unit can be used as follows:
Ö
For sterilizing solids such as glassware, heat-resistant rubber items, massive
metal items (instruments, bowls).
Ö
For sterilizing and drying porous materials, textiles, or tubes where it is
indicated that these are suitable for steam sterilization.
Ö
Implants certified for steam sterilization by the manufacturer and possessing no
lumens or fillings.
