Positive Control; Disposal; Interpretation Of Results - Terragene Bionova IC10/20FR Manual Del Usuario

Instructions for use
ticket will then be printed containing the following
information: reading position, incubation program
and remaining incubation time.
BIONOVA IC10/20FR
RAPID READOUT INCUBATOR
Date: DD/MM/AA
Time: HH:MM:SS
Tube 1:
PROGRAM: X Hs/ X °C
Remaning time= X min.
Tube 3:
PROGRAM: X Hs/ X °C
Remaning time= X min.
Tube 4:
PROGRAM: X Hs/ X °C
Remaning time= X min.
Tube 6:
PROGRAM: X Hs/ X °C
Remaning time= X min.
NOTE: This feature is available starting from the IC10/
20FR Rev. 2.5 Firmware version.
For the detailed procedure for updating the firmware,
please refer to the Firmware Update section of this user
guide.

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®
IC10/20FR incubator.
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.
-Proper functioning of Bionova® IC10/20FR incubator.

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). The processed BI results are
not valid until the biological indicator used as positi-
ve 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) after 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.
Take action on any positive result inmediately. A posi-
tive result indicates a sterilization process failure may
have ocurred. Determine the cause of the positive
BI following current facility policies and procedures.
Always retest the sterilizer and do not use the sterili-
zer for processing loads until 3 consecutive BI results
are negative.
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 readout is made, an hu-
midified incubator will be required to avoid media dry
out). If the sterilization process was not successful, the
growth media contained in the indicator will turn to
yellow. If the sterilization process was successful, the
media will remain unchanged. Color change to yellow
of the growth media shows a failure in the steriliza-
tion process. If after the incubation time (see biolo-
gical 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.
IC10/20FR Page 8