Remaining Incubation Time | Configured Programs; Positive Control; Disposal; Interpretation Of Results - Terragene Bionova IC10/20FRLCD Manual Del Usuario

Instructions for use
Remaining incubation time |
Configured programs
Bionova® IC10/20FRLCD Auto-reader allows to verify
remaining time of incubation and the configured pro-
grams of each reading position in a very simple way. To
do this, press on the icon
open indicating the remaining readout time of each
position that is performing an incubation. In positions
where there is no readout initiated, the name of the
selected program will be displayed. Press
to the main screen or just wait one minute to return
automatically.

Positive control

The positive control should belong to the same
batch of the processed BI.
Use a non-sterilized biological indicator as a
positive control every time a processed indica-
tor is incubated.
Incubate the processed biological indicator
and the indicator used as positive control as
long as specified in the instructions.
Press the cap to seal the tube and crush the ampoule,
make sure the media completely wets the carrier. Wri-
te a C (for control) and the date on the label. The posi-
tive control can be placed in any well of the Bionova®
IC10/20FRLCD Auto-reader.
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 im-
proper storage temperature, humidity, or proximity
to chemicals.
-Capability of the media to promote rapid growth
and the generation of fluorescence.
-Proper functioning of Bionova® IC10/20FRLCD Au-
to-reader.

Disposal

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

Interpretation of results

Rapid Readout
The indicator used as positive control should show
a positive result (red light
results are not valid until the biological indicator used
as positive control shows a positive result
A processed BI with a positive result indicates a failure
in the sterilization process. A negative result (green
light ) after 20 min. (60 °C), 30 min. (60 ºC), 1 h.
(60 ºC), 2 hs. (60 °C), 3 hs. (60ºC) 4 hs. (37 ºC) according
to the used program, indicates that the sterilization
process was effective.
.Then, a new screen will
to return
). The processed BI
.
IC10/20FRLCD Page 9
The presence of positive results indicates a steriliza-
tion process failure may have occurred and implies
that the load must be reprocessed immediately. Fa-
cing these results, verify good practices for load pre-
paration and usage of biological indicators. Check the
volume of the load to be sterilized as well as the BI's
position inside the load. In case the BI has been co-
rrectly used, it should be interpreted that it is likely
that the sterilizer has failed and maintenance is re-
commended.
Visual Readout
The Rapid readout system allows the confirmation of
results by color change after 48 hours or 7 days incuba-
tion analysis (if 7-day readout is made, an humidified
environment will be required to avoid media dry out).
If the sterilization process was not successful, the
culture medium in the indicator will turn to yellow,
as shown in the BIs Instructions for Use. If the sterili-
zation process was successful, the indicator medium
will remain unchanged. Color change to yellow of the
growth media shows a failure in the sterilization pro-
cess. If after the incubation time (see biological indi-
cators 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.

Hygiene monitoring system

Chemdye® PRO1 MICRO reading system
The Chemdye® PRO1 MICRO reading system consists
of an incubation position that allows the quantitative
analysis of the products destinated to cleaning and
contamination control.
IC10/20FRLCD device can perform a quantitative
analysis of the PRO1 MICRO Hygiene Monitoring
System, adjusted by a BSA (Bovine Seric Albumin) ca-
libration curve. This analysis allows carrying out the
traceability of the surface cleaning control.
This method presents a Detection limit of 1 μg and a
Sensibility of 0,3 μg. Nevertheless, for a better inter-
pretetation of results, these are informed with a reso-
lution of 0,5 μg.
Readings will be able to initiate once the incuba-
tion temperature has been selected and is stable.
The lights corresponding to the selected tempe-
rature (37 ºC or 60 ºC) will blink until the tem-
perature is reached, and then stay stable. PRO1
MICRO readings must be performed at 60 °C.
Reading process
1-Press icon . Then, the following screen will be
displayed: