Disposal; Interpretation Of Results; Audible Alarm; Cancellation Of A Reading - Terragene Bionova MiniBio Manual De Usuario

Instructions for use
Incubate the processed biological indicator and the
indicator used as positive control as long as speci-
fied in the instructions.
Press the cap to seal the tube and crush the ampoule, make
sure the media completely wets the carrier. Write a C (for
control) and the date on the label. The positive control can
be placed in any position of the Bionova® MiniBio incuba-
tor. The positive control should belong to the same batch
of the processed BI.
It is a good practice to use a positive control, this helps
ensuring:
-Correct temperature is reached.
-Viability of spores has not been altered due to improper
storage temperature, humidity, or proximity to chemicals.
-Capability of the media to promote rapid growth and fluo-
rescence generation.
-Proper functioning of Bionova® MiniBio incubator.

Disposal

Dispose Bls after use, according to your healthcare and
safety regulations. Positives BIs can be sterilized (see BIs
instructions for use).

Interpretation of results

Rapid Readout
The indicator used as positive control should show a po-
sitive result (red light). The processed BI results are not
valid until the biological indicator used as positive control
shows a positive result (red light). A processed BI with a
positive result (red), indicates a failure in the sterilization
process. A negative result, (green light) after 30 min. (60
ºC), 1 h. (60 ºC), 2 hs. (60 °C), 3 hs. (60 ºC) 4 hs. (37 ºC) accor-
ding to the used program, indicates that the sterilization
process was effective.
Take action on any positive result immediately. A positive
result indicates a sterilization process failure may have
occurred. Always retest the sterilizer and do not use the
sterilizer for processing loads until 3 consecutive BI results
are negative.
Visual Readout
The Rapid readout system allows the confirmation of re-
sults by color change after 48 hours or 7 days incubation
analysis (if 7-day readout is made, an humidified incuba-
tor will be required to avoid media dry out). If the sterili-
zation process was not successful, the growth media con-
tained in the indicator will turn to yellow, as it is shown
in Instruction of Use of BIs. If the sterilization process
was successful, the media will remain unchanged. Color
change to yellow of the growth media shows a failure in
the sterilization process. If after the incubation time (see
biological indicators directions for use), no color change
is noticed in the processed indicators, then the result is
negative (the sterilization process was successful).
The color of the growth media in the BI used as
positive control must turn to yellow during the
process of incubation for the results to be valid.
Record the positive ones and discard them im-
mediately as shown in the biological indicators
instructions for use.

Audible alarm

An audible alarm will sound every time a positive result
is detected in the Bionova® MiniBio incubator. The alarm
allows the user to immediately detect a positive result
without the need to visually control the equipment. The
alarm can be cancelled by pressing the button

Cancellation of a reading

When a BI is removed from its position during incubation
process, an audible alarm will sound to indicate that the
tube should be returned to the corresponding position.
If the indicator is not re-introduced into the reading posi-
tion after 10 seconds of being withdrawn, the reading will
be cancelled and the cancelation will be informed throu-
gh the printing of a ticket.

Temperature monitoring

The Bionova® MiniBio incubator contains an internal tem-
perature control. If the temperature falls outside of the spe-
cified range (37±2) ºC or (60±2) ºC, the blue temperature
led light will start to twinkle.
Temperature can be externally monitored by using a Bio-
nova® TB- IC1020 thermometer or other similar. The Au-
to-Reader MiniBio has a special hole for placing the ther-
mometer which is located at the right side of the device.
Bionova® MiniBio Page 9
.