Positive Control; Interpretation Of Results; Disposal; Results History Visualization - Terragene IC10/20FRLCD Manual De Instrucciones

Instructions for use
9.To register the tickets, press the button for paper traction, take
the paper and pull to cut it with the serrated edge of the printer.
NOTE: If the paper runs out, the light of paper
replacement will start blinking (see Replacement of the
paper roll in the printer).
NEGATIVE POSITIVE

Positive control

The positive control should belong to the same
batch of the processed SCBI.
Incubate the processed biological indicator and
the indicator used as positive control as specified
in the SCBI instructions.
Read the instructions for use of each SCBI for
more information.
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 well of the Bionova
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 the
generation of fluorescence.
•Proper functioning of Bionova

Interpretation of results

Rapid Readout
The indicator used as positive control should show a positive
result (red light ). The processed SCBI results are not
valid until the biological indicator used as positive control
shows a positive result
positive result indicates a failure in the sterilization process. A
negative result (green light
(60 ºC), 1 h. (60 ºC), 2 hs. (60 °C), 3 hs. (60 ºC) 4 hs. (37 ºC)
according to the used program, indicates that the sterilization
process was effective.
The presence of positive results indicates a sterilization
process failure may have occurred and implies that the load
CANCELED
IC10/20FRLCD Auto-reader.
®
IC10/20FRLCD Auto-reader.
®
. A processed SCBI with a
) after 20 min. (60 °C), 30 min.
IC10/20FRLCD Page 9
must be reprocessed immediately. Facing these results, verify
good practices for load preparation and usage of biological
indicators. Check the volume of the load to be sterilized as well
as the SCBI's position inside the load. In case the SCBI has been
correctly used, it should be interpreted that it is likely that the
sterilizer has failed and maintenance is recommended.
Visual Readout
The Rapid readout system allows the confirmation of results
by color change after 48 hours or 7 days incubation analysis (if
7-day incubation is performed, 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
SCBIs Instructions for Use. If the sterilization process was
successful, the indicator medium will remain unchanged.
The color of the growth media in the SCBI 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
immediately as shown in the biological indicators
instructions for use.

Disposal

Dispose SCBls after use, according to your country's healthcare
and safety regulations (see SCBIs instructions for use). It is not
possible to reuse a SCBI.

Results history visualization

IC10/20FRLCD Auto-reader automatically stores the last 208
reading results. You can access these results by pressing the icon
. After this, a screen will be displayed to show the results ordered
cronologically. The ticket of the desired result will be reprinted by
pressing on its corresponding line.
You can also access the visualization of the results by accessing the
website of the equipment (see Website of the equipment section).

Audible alarm

The auto-reader is equipped with several alarm functions that
indicate different states after the incubation.
In the case of the biological indicators, an alarm will go off whenever
the Bionova IC10/20FRLCD Auto-reader emits a positive result.
®
This will allow the user to immediately detect a positive result
without visually verifying the result on the equipment.
The alarm can be cancelled by pressing the button
The hygiene monitoring system, is equipped with an alarm that the
auto-reader will set off 30 seconds before the program cycle ends
and will last until the reading is complete, notifying the operator that
the incubation time will be fulfilled. The color of the solution can be
used for a qualitative reading only if the pen is removed once the
program finalizes. If the pen is not removed at that time, the color of
the solution will continue to evolve.
.