1.Pack the Biological Indicator Monitore - IB1H in a package
(huckaback), following the recommended practices of
sterilization, place the package in a more challenging location
inside the autoclave chamber, usually near the door, or
to the drain.
2. perform the sterilization cycle normally, wait for the time to elapse.
autoclave cooling recommended by the manufacturer and remove
the Biological Indicator Monitor - IB1H from the package and break the

glass ampoule in an appropriate place in the incubator, or by using-
Take a pair of pliers specifically designed for this purpose and insert the

ampoule in an incubator cavity.
3. always use an unprocessed ampoule as a pilot, or
against proof, of the same manufacturing batch, in order to prove the
presence and bacterial growth.
Fluorescence reading
Incubate the processed Biological Indicator Monitore - 1B1H and the
indicator to be used as a pilot or positive counter test by the
period of 1 hour, between 58oC and 62oC in an incubator suitable for
fluorescence reading.
Note: Make sure that the incubator's reading time is correct.
used is compatible with the 1B3H Biological Indicator. Stay
pay attention to the positivity of the pilot vial, which should occur around
1/2 hour after the start of incubation. If the critical parameters
of the autoclave are adequate and successfully achieved, i.e,
temperature, presence of sterilizing agent and time of .

exposure, within 1 hour the reader/incubator should negative the
processed ampoule, by means of an alarm and a (green) light on the panel.
Visual reading
If the sterilization process fails, the culture medium of
purple color will change to gray/green and then
to yellow color, after incubation between 58oC and 62oC for 24
hours, indicating the presence of live Geobacillus spores
Stearotherrnophilus. If the sterilization process is satisfactory,
the culture medium will remain purple.
Attention
Use the Biological Indicator Monitor IB1H - Only for
steam autoclaves. Do not reuse biological indicators.
It is recommended to use at least three units of the Indicator
Biological IB1H, inside the autoclaves to monitor each
steam sterilization cycle.
Storage and disposal
Store away from light, at a temperature between 15°C and 30°C and
relative humidity between 35-60%. Do not freeze.
Do not store near sterilizing or other agents
chemical products.
After using the indicators, dispose of them in accordance with the
health regulations. Positive biological indicators
must be sterilized in an autoclave during its normal cycle
before being discarded.
Validity
24 months from date of manufacture

MS registration. Product not considered a "Health Product"
according to Resolution - RDC 40 / 2015 of the Collegiate Board of
National Health Surveillance Agency, published in the Official Gazette of
26/08/2015.
Classification: AAMI ST79 - ISO 11138-3 - USPXXIII