
8
1.7 Functional testing of the steam sterilizer _________________________________
Regular checks
The microprocessor control for the MELAtronic auto-
matically monitors sterilization temperature and time.
You can check the pressure gauge during sterilization
(white pointer). After sterilization, the red non-return
(slave) pointer will show the maximum pressure
reached. If there is no error message in the display at
the end of the program, and if the red non-return
pointer is between 1 and 1.3 bar for Program 1
(121°C) or between 2 and 2.4 bar for Program 2
(134°C), and if the loading instructions have been cor-
rectly observed (see Sections 3.1 and 3.2), then you
can assume that effective sterilization has taken
place.
Periodic checks (every six months)
German standard DIN 58 946, Part 8, Section 3.2,
recommends:
“Period testing should take place at the site of use, at
recommended intervals of six (6) months. The pur-
pose of testing is to verify that the small-size sterilizer
effectively sterilizes upon observance of operating in-
structions.”
Hygiene institutes and state medical laboratories will
provide test spores upon request. They analyse these
spores and provide test results on a test form.
DIN 58 946, Part 4 and DAB 10 (official German Phar-
macopoeia), stipulate that Bacillus Stearothermophi-
lus spores (for example, the product ATCC 7953, Pa-
per Spore Strips, supplied by the company Oxoid, Cd.
number BR 23), must be used to test steam steam
sterilizers.
As stipulated, five bioindicators (plus a positive sam-
ple) are necessary to test the MELAtronic 23 (cham-
ber volume > 5 dm³), in accordance with
DIN 58 946, part 8.
If the test spores already are already packed (for ex-
ample, spore strips in paper packs, test tubes, or the
product Attest), do not pack them again in addi-
tional enclosures when you place them in the steam
sterilizer.
When conducting a spore test, the most stringent ste-
rility precautions are necessary to prevent re-contam-
ination. For example, after sterilization do not pack
the spore packets into the same envelopes used to
send them to you. Also do not use the same tweezers
after testing as before. We recommend sterilizing the
tweezers along with the test spores. To avoid falsify-
ing your results in making your analysis, do not allow
the non-sterilized positive sample to come into con-
tact with the sterilized test spores. For transport pur-
poses, you can also submit your positive sample in a
paper package that you have also sterilized.
Important note:
If the test spores are in a tube that is perforated only
on one side (for example, the product Attest by 3M),
then observe the following:
Never place these tubes into the steam sterilizer with
the perforation pointing upward (with Attest, the per-
foration is in the brown closure cap). Since this steam
sterilizer functions by the gravitation principle, the
perforation should ideally point downward: but at least
toward the side (as is the case for tubes).
If you are using “handmade” test-spore products that
are directly sealed in a paper-film package, then en-
sure that the paper sides are freely exposed to the
steam. The paper sides of the package should like-
wise point to the side or downward.
2 Placing the steam sterilizer into operation
2.1 Setting up the steam sterilizer __________________________________________
Electrical connection
The steam sterilizer must be powered from a sepa-
rate circuit. This circuit must be additionally protected
by a quick circuit breaker.
Open intervals to the sides
The steam sterilizer must be set up with an open in-
terval of at least 10 cm from the nearest walls. The
open space above the steam sterilizer should be at
least 30 cm. It is very important for proper sterilization
that the steam sterilizer be correctly set up. The fol-
lowing instructions must therefore be very carefully
followed: both for the first installation, as well as for
any change in location.
Correct setting up of the steam sterilizer
This MELAG steam sterilizer uses its own, direct
supply of water. This convenience makes it very im-
portant that the steam sterilizer operate on a per-
fectly level surface. Please use a spirit level (water
level) to properly level the steam sterilizer. To ena-
ble proper alignment of the steam sterilizer, MELAG
supplies a graduated measuring beaker with every
steam sterilizer. To check whether the steam steri-
lizer has been properly levelled, use this graduated
measuring beaker to fill the following amounts of dis-
tilled or demineralized water from the front into the
sterilization chamber: 400 ml.
If the steam sterilizer has been correctly aligned, the
water filled into the unit will just be visible at monitor-
ing section (14) of the tray rack. If the water is not
visible as described above, turn the front adjustable
feet of the steam sterilizer (15) until the steam steri-
lizer is properly levelled, and the water is just visible.
Important: When putting the steam sterilizer into
operation for the first time, be sure first to run the
134°C sterilization cycle once without any objects
in the sterilization chamber.
Incorrect: setting up on a surface sloping toward
the front of the steam sterilizer
If you try to install this steam sterilizer on a surface
that slopes to the front of the steam sterilizer, the dis-