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2.4 Functional testing of the autoclave_________________________________________
2.4.1 Continuous monitoring _______________________________________________________________
The operator of the autoclave can monitor the effectiveness of the sterilization or disinfection processes by
checking the values displayed on the autoclave itself, or by reading the log output by the printer. The user
can assume that the sterilization or disinfection process has been satisfactorily carried out if the following
conditions are met:
1. The parameters of pressure and temperature (which depend on the program executed) agree with the
display on the autoclave
2. The sterilization or disinfection time was correct as stipulated.
The parameter control system of the Vacuklav
®
31 automatically monitors whether these conditions are in
fact met. If they are not in range, the Vacuklav
®
31 will issue an error report.
In addition, the operator can install a printer which outputs a printout log, with a list of the process-relevant
parameters for each program.
2.4.2 Periodic testing (every six months) _____________________________________________________
German DIN 58 946, Part 8, Section 3.2, recommends as follows:
"Periodic testing is conducted at regular intervals (e.g., every six months) at the site of installation and opera-
tion. The purpose of this periodic testing is to verify that a small-size sterilization unit satisfactorily carries
out sterilization when it is used according to the operating instructions."
The operator can request test spores from hygiene institutes and government medical testing offices. These
institutions send test spores as requested, analyze them when they are returned after sterilization, and con-
firm the results of sterilization on an official test log.
Spore tests to confirm the effectiveness of sterilization of an autoclave provide valid results only in conjunc-
tion with the
sterilization
programs of the Vacuklav
®
31.
When conducting a spore test, the operator must absolutely and strictly observe sterile working conditions.
For example: the spore packets may not after sterilization be placed back into the envelopes from which
they were taken before the process. Contaminated tweezers may also not touch the spore samples. Oth-
erwise, the spore substance will be recontaminated. The MELAG company therefore recommends that the
tweezers be sterilized together with the spore sample. The positive sample which is not sterilized must be
kept separate from the sterilized sample.
2.4.3 Maintenance / service of the autoclave __________________________________________________
The functional effectiveness and the long service life of the autoclave will depend on periodic service / main-
tenance of the unit.
The MELAG company recommends that annual service of the Vacuklav
®
31 be performed: but only by
trained customer-service technicians and in accordance with the Vacuklav
®
31 Maintenance Worksheet.
This annual service consists of a visual inspection and a functional test. Such annual service not only in-
cludes testing of all equipment components and electrical elements, but also requires the replace of worn
parts.
If the Vacuklav
®
31 is operated in conjunction with a MELAdem
®
45 reverse-osmosis system, then the ME-
LAdem
®
45 must be serviced at intervals of not longer than six months. If the Vacuklav
®
31 is operated in
conjunction with water-treatment systems manufactured by other companies (OEM), the service instructions
of these OEM companies must be strictly observed.
For information concerning these service operations, please get in touch with your specialist dealer, or with
the MELAG Customer Service Department.
