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The SteriSet System
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VALVE CONCEPT
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SteriSet's valves are electrolytically polished stainless
steel disks of a certain shape which, in the absence of a pressure difference, are sealed together by a
spring.
So closed they form an effective barrier against
microbial penetration during hospital storage and handling, but when exposed to the changes in pressure during a sterilization
cycle, the discs are pushed open and allow passage of gases with virtually no resistance to flow (a filter by
comparison has a greater resistance to flow) until pressure equalization is achieved.
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The valve members (green
and blue in the below pics.)
are assembled in the inner protected lid of SteriSet containers
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Red = outer environment
White =between the two lids
Green=OUTER valve member
Blue = INNER valve member
Yellow = inside the container
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When pressure is raised, steam travels trough the annulous gap between the two
lids,
penetrates the perforated OUTER VALVE MEMBER, pushes the INNER VALVE MEMBER open against his inner spring, then
travels trough the now open pathway into the container ...
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When pressure drops (vacuum), steam pushes the INNER and OUTER VALVE MEMBER upwards
against both springs in the system, travels through the now open pathway(s) and finally escapes through the
annulous gap between the two lids from the container...
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In the absence of a difference of pressure the spring loaded valve members snap back
to the sealed status...
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Sealed: the polished steel disks contact their counterpart - forming a
very long and narrow gap (which is not gas tight, but a effective
barrier against microbial penetration during hospital storage and
handling).
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The SteriSet
valve system is a example for a technologically advanced system for supply of sterile goods to the OR.
It complies to the
relevant standards
- CEN
(European
Standard on packaging materials for sterilization) 868-1 and –8
- (former) DIN 58 952 / 58 953 (German Standard Institute)
- CE-mark
declared
(= conformity to the European
Medical Device Directive)
- FDA (US Food&Drug association) 510K
Pre-marketing Notification
for class II device on file.
The
VALVE system increases the safety of handling containers (no
exchange of filters needed), is truly cost
effective (no disposables) to use and designed for being
truly reusable.
During
the serviceable life (of typical 10 years) the system needs no other special care or maintenance as the regular
control for absence of corrosion and physical integrity of the general shape - as it is also done with
other comparable systems.
(Use acccoring instructions provided)
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