Terragene Bionova IC10FR User manual

Rev.1 FDA | May 2019
IC10/20FR
Warning: this product contains dry natural rubber

IC10/20FR Page 3
Terragene Bionova® IC10/20FR Auto-reader has been
designed for the incubation of the following Self-Con-
tained Biological Indicators (BIs):
• Rapid Readout Self-Contained Biological Indicators:
BT220 and BT221 for Steam sterilization control.
• Super Rapid Readout Self-Contained Biological Indi-
cators: BT222 and BT223 for Steam sterilization control.
Indicators for sterilization control, should be incubated
at 60 ºC.
Terragene Bionova® IC10/20FR Auto-reader allows easy
and rapid detection of positive and negative Biological
Indicators. Incubation programs are available: 3 hours
at 60 ºC, 1 hour at 60 ºC, 30 minutes at 60 ºC. A positive
result can also be evidenced by culture medium color
change to yellow, read the instructions for use of each
Description of use
Constituent parts
15
16
indicator for more information. The choice to perform
or not the extended incubation to conrm by color
change depends on the internal protocols of each labo-
ratory or hospital. The auto-reader allows selection of
incubation time programs for two zones in an indepen-
dent way. Zone 1 includes positions 1 to 6, and zone 2
comprises positions 7 to 12.
Terragene Bionova® IC10/20FR Auto-reader not only
allows the detection of results, but also provides a prin-
ted ticket to record them. In addition, the auto-reader
can be connected to computers by USB. This allows lin-
king the results with the Bionova® Traceability Software
for Automatic Reading and Traceability of Rapid and Su-
per Rapid Biological Indicators. To download the latest
version of the software, go to: http://www.terragene.
com.ar/productos/infection-control/incubators/sof-
tware-downloads/ ?lang=en, from there you can also
download the user manual.
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1
2
3
10
11
9
12
14
13
8
6
712

IC10/20FR Page 4
Safety information
To avoid risks and damaging the equipment
-Do not place the auto-reader in an environ-
ment exposed to direct sunlight or high inten-
sity light lamps.
-Do not place the auto-reader near devices that
emit electromagnetic elds.
-Do not use the equipment on vibrating surfa-
ces.
-Do not pour any liquid inside.
-Do not immerse into any liquid.
-Use indoors only.
-Disconnect the power cord before cleaning.
-Do not use abrasive, corrosive cleaners or di-
sinfectans.
-In case of technical fault, contact the manufac-
turer for support. Please, do not try to open or
repair the auto-reader on your own, since this
will imply the loss of product warranty and
could lead to a major and irreversible damage.
-Make sure that the auto-reader is connected
to a properly rate power cord.
To reduce the risk of using incompletely ste-
rilized loads:
-Make sure to use each BI with its incubation
and reading program:
BT220 (brown top) with 3hs. (60 ºC) program.
BT221 (blue top) with 1 h. (60 ºC) program.
BT222 (violet top) with 1 h. (60 ºC) program.
BT223 (light blue top) with 30 min. (60 ºC) program.
-Check that culture medium completely wets
the spore carrier.
-Do not remove the BI until the equipment re-
ports the nal readout result, check the impre-
sion of the ticket.
To avoid the risk of injury, because of glass
fragments generated after the glass ampou-
le inside the BI tube is crushed:
-Cool the BI during the indicated time before
crushing the ampoule.
-Do not handle the BI excessively since this mi-
ght cause the glass ampoule to burst.
-Wear safety glasses and gloves when remo-
ving the BI from the sterilizer.
-Wear safety protective glasses and gloves to
crush the ampoule and to press the cap of BI.
-Do not use your nger for crushing BI.
To avoid a potencially hazardous situation:
avoid contact with the hot surface of the metal
auto-reader block.
To avoid BIs from absorbing uorescent re-
sidues: avoid BIs direct contact with chemical
indicators or tapes.
Do not use this product in a manner not speci-
ed by Terragene® S.A., otherwise the protec-
Symbols
References
Operating relative humidity.
Operating environmental temperature.
Caution, warning.
Caution: Risk of electric shock.
Caution: Hot surface.
Important, attention.
Manufacturer.
European conformity.
Serial number.
Direct current.
Product denomination.
80 %
30 %
10 ºC
30 ºC
REF
Protective cover.
Red light/Positive indicator/Position Light.
Green Light/Negative indicator/Position Light.
Reading position number.
Program selector.
Temperature Selector.
Alarm Cancellation Button.
Thermal printer.
Printer’s light.
Paper’s traction button.
Cavity for paper.
USB port.
Input for power source plug (12V DC).
Control Panel.
Incubation area for 12 BIs. Protein pen detec-
tion. BIs Ampoule crusher.
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2
3
4
5
6
7
8
9
10
11
12
13
14
15
16 Hole for external temperature control.

IC10/20FR Page 5
Power supply specications
Environment operating conditions
Terragene® recommends using a UPS instead of stabi-
lizers, since the former has two functions: it stabilizes
and provides a continual power source during energy
cuto.
Serial/Batch Number
For easy identication, each IC10/20FR Auto-reader
has a unique serial number and a batch number prin-
ted on a label found at the bottom of the auto-rea-
der and on its packaging. Please, register your serial
number and batch number in this manual for future
reference:
Serial Number:
Batch Number:
Safety information
Record Table
Use the following table to record rmware updates.
NOTE: manufactury rmware is printed on a label found
on the bottom of the auto-reader and on its packaging.
tion provided by the product might be aec-
ted.
Do not replace the power supply cord for other
not provided within the product.
Only personnel authorized by Terragene® S.A
can access the inside of the auto-reader and
its components. Parts or components inside
the machine should not be manipulated by the
user.
Input parameters
Voltage range
Frequency
Current
Output parameters
Voltage
Current
Operating
Condittion
(100-240)
50/60
0.2
Values
12
4
Units
Volts
Hertz
Ampers
Units
DC Volts
Ampers
Environmental conds.
Altitude
Operation temperature
Relative humidity
Installation/overvoltage
Degree of contamination
Storage temperature
Voltage
Functional conds.
3500 (máx.)
10-30
30-80
category II
2
10-30
12
Units.
Meters
ºC
%
°C
DC volts
Date Version Operator
Please, register your manufactory rmware in this ma-
nual for future reference:
Manufactury Firmware: