Loading Example - KaVo STERIclave B 2200 Operating Instruction

Operating Instruction STERIclave B 2200 / 2200 P

5 Loading example

5 Loading example
The validation of the example loads was carried out and successfully concluded with
the following programs:
▶ STERIclave B program 1 / Sterilise 1
134℃ + - 1℃, three pre-vacuum phases, holding time: 5 min
▶ STERIclave B Program 3/Fast Cycle
134℃ + - 1℃, two pre-vacuum phases, holding time: 4 min
The example loads represent the loads which are most difficult to sterilise according
to KaVo in the field of dental medicine. it is not possible or recommendable to vali‐
date all the loads conceivable in practice.
An experienced user can, however, draw conclusions from the loads that he spe‐
cifies.
The loads must be rated against the example loads.
The rating specially depends on the type and amount of instruments and their sterile
packaging.
If the rating indicates that the load/packaging deviates from the sterilisability of the
example load, another validation must be performed. The responsibility lies with the
operator of the medical device (see medical device operator instructions MP-Be‐
treibV).
KaVo recommends a process evaluation system according to EN 13060:2004, An‐
nex B for the STERIclave 2200 (without a printer).
EN 13060:2004 / Annex B (informative)/process evaluation system
Normally, a steam sterilisation process is evaluated by recording the physical pa‐
rameters of pressure, temperature and time. A well trained user is capable of
evaluating the sterilisation process and deciding if the loads are sterilised and ready
to use or not. Users of small steam sterilisers are not always able to evaluate the
sterilisation process based on the records of the physical parameters.
The use of a recording device for a small sterilisers should be considered if the user
is expected to provide an appropriate evaluation, or when a printout is needed. As
an alternative to a strip chart recorder, a process evaluation system can be used.
This system monitors the different factors that are necessary for ensuring sterilisa‐
tion and shows the user if the cycle can be accepted or not. A process evaluation
system should answer the same questions as a user who is evaluating the recor‐
dings.
▶ Was/were the pressure(s) in the first vacuum and all subsequent vacuums low
enough?
▶ Was the time to achieve the pressure(s) within the limits?
▶ Was/were the pressure(s) in the first steam injection and all subsequent injecti‐
ons high enough?
▶ Was the time to achieve the pressure(s) within the limits?
▶ Was/were the pressure(s) during the holding time within the limits?
▶ Was the time to achieve the pressure(s) within the limits?
▶ Was the temperature during the holding time within the limits?
▶ Were the temperatures including the theoretical temperature during the holding
time within the limits?
▶ Was the holding time long enough?
▶ Was/were the pressure(s) during drying low enough?
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