Terragene BIONOVA MiniBio User manual

Rev.8 | May 2020
MiniBio
Innovation in technologies for Infection Control
Warning: this product contains dry natural rubber
A
uto-reade
r
for Rapid, Super Rapid and
Ultra Rapid Biological Indicators

Composition....................................................................................................................................................................... 4
Product description................................................................................................................................................................................................4
Indications for Use.................................................................................................................................................................................................5
References...............................................................................................................................................................................................................5
Safety information.............................................................................................................................................................. 5
Symbols....................................................................................................................................................................................................................5
Operating conditions .............................................................................................................................................................................................6
Power supply specifications ......................................................................................................................................................................6
Environment operating conditions............................................................................................................................................................7
Device Safety Compliance....................................................................................................................................................................................7
Product Compatibility and Incubation programs ............................................................................................................................................7
Bionova®MiniBio Incubation Programs ..................................................................................................................................................7
Bionova®MiniBio Auto-reader compatible indicators...........................................................................................................................7
Serial/Batch Number .......................................................................................................................................................... 7
Instructions for use ............................................................................................................................................................ 8
Start-up.....................................................................................................................................................................................................................8
Remaining incubation time ..................................................................................................................................................................................9
Positive Control.......................................................................................................................................................................................................9
Interpretation of results .......................................................................................................................................................................................10
Disposal...................................................................................................................................................................................................................10
Audible alarm .........................................................................................................................................................................................................10
Cancellation of a reading.....................................................................................................................................................................................10
Temperature monitoring......................................................................................................................................................................................10
Thermal paper specifications.............................................................................................................................................................................11
Replacement of the paper roll ............................................................................................................................................................................11
Reprinting of results .............................................................................................................................................................................................11
Setup Mode ............................................................................................................................................................................................................11
Time setting mode................................................................................................................................................................................................12
Cleaning and maintenance..................................................................................................................................................................................12
Additional features ............................................................................................................................................................ 12
Firmware update ...................................................................................................................................................................................................12
Bionova®Traceability Software..........................................................................................................................................................................13
Troubleshooting ................................................................................................................................................................ 14
Warranty............................................................................................................................................................................ 15
Limitation of liability..............................................................................................................................................................................................15
Technical assistance............................................................................................................................................................................................15
Index

Bionova®MiniBio Page 4
1
2
34
5
6
Bionova®MiniBio Auto-reader has been designed for the
incubation and automatic readout of Terragene®Rapid, Super
Rapid and Ultra Rapid Self-contained biological indicator(SCBIs)
appropriate for a wide range of sterilization control applications.
Bionova®MiniBio allows two different incubation temperatures,
37°C or 60°C. Microorganisms contained within the SCBIs vary
depending on the sterilization process for which they have been
designed, therefore, incubation temperatures and incubation
times differ depending on the SCBI being used. Bionova®
MiniBio allows independent time settings selection for each one
of the three incubation positions.
SCBIs for Ethylene Oxide (EO), should be incubated at 37 ºC,
while those used for the monitoring of the rest of the sterilization
processes should be incubated at 60 ºC.
Product description
Composition
17
16
18
7
8
9
11
12 13
10
14
15
Please check the Product Compatibility and Incubation programs
section for more information about Incubation Programs and
new available Indicators for your Bionova®MiniBio.
Bionova®MiniBio Auto-reader allows easy and rapid detection
of positive and negative SCBIs using advanced fluorescence
techniques. A positive result can also be evidenced by culture
medium color change when performing extended incubations.
Read the instructions for use of each SCBI for more information.
The option to perform or not an extended incubation depends
on the internal protocols of each laboratory or hospital.
Bionova®MiniBio Auto-reader also provides a printed ticket
each time an incubation is completed for recording the results.
This allows for easy result management, for documentation
compliance and safe-keeping.
Simultaneous incubation of SCBIs for monitoring
EO processes along with SCBIs for monitoring other
sterilization processes is not possible.

Bionova®MiniBio Page 5
References
Indications for Use
Symbols
Safety information
To avoid risks and/or damaging the device:
•For indoor use only.
•Do not place the incubator in a room exposed to
direct sunlight or to high luminous intensity lamps.
•Do not place the incubator near devices that emit
strong electromagnetic fields.
•Do not use the incubator on leaned surfaces
or on surfaces that are subject to shocks,
vibrations,temperature or high relative humidity.
•Disconnect the power cord before cleaning.
•Do not use abrasive, corrosive cleaners or
disinfectants.
•Do not immerse into any liquid . Do not pour any
liquid inside.
•Make sure the incubator is connected to an
appropriate electrical mains outlet socket.
•Use only the included power supply (AC power
Terragene®Bionova©Reader Incubators (Mini-Bio) incubate
at 60°C and 37°C and read the Terragene®Bionova©SCBI for
fluorescent results at the times prescribed in the User Manuals.
Blue Attention Light.
Protective Cover.
1
Incubation Area.
2
Control Panel.
3
Incubation Time Selection Buttons / Time Left.
8
9
Red Light / Positive Indicator.
10
7Incubation Temperature Selection Button.
6Thermal Printer.
Green Light / Negative Indicator.
11
Incubation Position.
12
Alarm Cancellation Button.
13
15 Configuration / Paper Traction Button.
5Cavity for Paper.
17 Input for Power Supply Plug (12Volts DC).
16 Hole for External Temperature Control.
14 Reprint of Results.
4Ampoule Crusher.
USB Port.
18
Operating relative humidity.
Operating temperature.
Caution, Warning, Attention - Refer to the
instructions for use.
Caution: Hot surface.
Important.
Direct current.
For indoor use only.
Keep away from sunlight.
Batch code.
Manufacturer.
Separate collection for waste of electrical and
electronic equipment.
80 %
30 %
10 ºC
30 ºC
LOT
Safety information

Bionova®MiniBio Page 6
Important
Do not use this product in a manner not specified by
Terragene®S.A., otherwise the protection provided
by the product might be affected.
Only Terragene®S.A. authorized personnel can
access or service the internal components of the
Incubator. Parts or components inside the Incubator
should not be manipulated by the user.
Power supply specifications
Operating conditions
Input
parameters
Voltage range
Frequency
*Current
Output parameters
Voltage
**Current
Operating
conditions
(100-240)
50/60
0,5
Values
12
2
Units
AC Volts
Hertz
Amperes
Units
DC Volts
Amperes
* 1 Ampere in USA and Canada.
** 3 Amperes in USA and Canada.
Terragene®S.A. recommends the use of UPS instead of voltage
stabilizers, since they fulfill two functions: to stabilize and
maintain the energy during a power outage.
Safety information
adapter), power supply’s AC plug, power supply
cords, and USB cable. Verify that all the included
elements are in good condition on daily basis. If
any of them is damaged, discontinue their use.
The use of cables, adapters, cords, and/or power
supplies different from the ones included may
cause fires, electrical shocks, or even physical
injuries.
•Do not plug any devices into the Incubator’s USB
port other than a personal computer (PC). The PC
has to be compliant with IEC60950-1, IEC 62368-1
or comparable, with safety extra-low voltages on
its USB ports. Ask a qualified technician to verify
device compatibility. Attaching any other device to
the USB port may damage the incubator and may
not be safe for the user.
•Do not attempt to repair the incubator by yourself,
that could lead to major and irreversible damages
to the device. In case of device malfunction,
contact your local distributor for further
assistance.
To reduce the risk of using incompletely
sterilized loads:
•Please read, understand, and follow the
Instructions for Use of each SCBI before its
incubation.
•Do not remove the SCBI before the incubator
reports the final readout result. Check a result
ticket is printed.
•Check that culture medium completely wets the
spore carrier.
To avoid the risk of injury, related to glass
fragments produced when crushing the glass
ampoule inside the SCBI tube:
•Cool the SCBI during the indicated time before
crushing the ampoule.
•Do not handle the SCBI excessively since this
might cause the glass ampoule to burst.
•Wear safety gloves and glasses when removing
the SCBI from the sterilizer, pressing the SCBI’s
cap, and crushing the SCBI’s ampoule.
•Do not use your finger for crushing SCBI. Use the
Ampoule Crusher instead.
To avoid a potentially hazardous situation:
•Avoid contact with the hot metal block inside each
incubation position.
•Do not insert your fingers, or any other element,
inside the incubation positions.
•Place only compatible indicators inside the
incubation positions.
To avoid SCBIs from absorbing fluorescent particles:
•Avoid direct contact between the SCBIs and Chemical
Indicators or Tapes before the SCBI incubation.

Bionova®MiniBio Page 7
Select the appropriate incubation program before
the incubation of any Indicator.
Bionova®MiniBio Auto-reader Incubator complies with the
following standards and directives:
We develop new Indicators for extending the features of our
incubators regularly. Please visit www.terragene.com.ar/
compatible or scan the QR code below to check the latest
compatible Indicators developed for your incubator.
Bionova®MiniBio Auto-reader Incubator do not represent
photobiological risk and do not generate dangerous optical
radiation in any of its normal operation conditions as per the
requirements of IEC 62471 Standard.
Designed under Quality Management System standards ISO
13485:2016/NS-EN ISO 13485:2016.
The following incubation programs are available for your
Bionova®MiniBio. Verify which incubation programs are available
for your country checking the Indications for Use section.
To select the appropriate incubation program for the Indicator you
are planning to use, follow each Indicator’s Instructions for use.
Environment operating conditions
Device Safety Compliance
Bionova®MiniBio Auto-reader compatible indicators
Product Compatibility and
Incubation programs
Bionova®MiniBio Incubation Programs
Environmental
Conditions
Altitude
Operation temperature
Relative Humidity
Installation/overvoltage
Degree of contamination
Storage temperature
Voltage
Electrical Safety.
Electromagnetic
Compatibility (EMC).
European Commission.
Operating
Conditions
3500 (máx.)
10-30
30-80
category II
2
10-30
12
IEC 61010-1
IEC 61010-2-010
Low Voltage Directive
2014/35/EU.
EN 61326-1
EMC Directive 2014/30/EU
RoHS Directive 2011/65/EU.
WEEE Directive 2012/19/EU.
Units
Meters
Celsius
%
Celsius
DC Volts
Serial/Batch Number
For easy identification, each Bionova®MiniBio Auto-reader
Incubator has a distinctive serial and batch numbers. The number
can be found printed on two labels, one placed at the bottom of the
Incubator, and one on its packaging. Please, register your serial and
batch numbers in this manual for future reference:
Serial number:
Batch number:
Temperature
selection
60 ºC
37 ºC 4 hs. 4 hours at 37°C
Time selection
20 min (Ultra)
30 min
1 hs.
2 hs.
3 hs.
Incubation Program
20 min. at 60°C
30 min. at 60°C
1 hour at 60°C
2 hours at 60°C
3 hours at 60°C
Safety information

Bionova®MiniBio Page 8
All devices are manufactured with the following
settings:
- Time zone: UTC +0:00
- Printing language: English.
Before power on, verify that all incubation
positions are empty.
If the Blue Attention light starts blinking after
powering on the Incubator, check that the
printer’s door is tightly closed and that the printer
has paper, if not follow the instructions on the
Replacement of the paper roll section.
temperature program must be selected. Press the button
to select the incubation temperature program, 37 ºC or 60 ºC.
After 3 seconds, temperature modification will be accepted.
For 37 ºC, Bionova®MiniBio Auto-reader will automatically
select 4 hs. final readout for all positions.
For 60 ºC the incubator allows choosing between Ultra (20
minutes), 30 minutes, 1 hour, 2 hours or 3 hours final readout.
It is possible to select an incubation program for each of the
positions depending on the final reading characteristics of the
indicators to be used.
Check that the time setting is appropriate for the SCBIs to be
incubated in each position.
To change the time program, press the button of the
correspondent position as many times as necessary to choose
the right setting.
5- Wait for the temperature of the machine to be stable. Once is
stable, the indicator of the desired temperature will remain steady.
Instructions for use
Start-up
Instructions for use
1. Place the Bionova®MiniBio Auto-reader Incubator on a
firm surface, free from vibrations, away from direct sunlight,
currents of hot or cold air, chemical and corrosive or flammable
substances. Do not place the Incubator in a way that
disconnection of the power supply’s AC plug from mains could
be difficult. Leave a space of at least 10 cm from the Incubator
to the closest wall. Do not move the Incubator periodically or
during its use. Connect the Incubator to a secure and stable
electrical mains outlet socket.
Do not wet or heat the device. If liquid is spilled
on the Incubator, disconnect it and follow the
instructions on the Cleaning and maintenance
section.
2. Power on your Bionova®MiniBio by connecting the power
supply’s AC plug to mains and then connect the plug at the
other end of power supply to the rear of the Incubator. The last
incubation program used (time and temperature combination)
will be selected by default.
3. Set the incubator internal clock to correspond to your local time.
See configuration methods in the Time setting mode section.
If you want to change the time zone, or the printing language
refer to Modification of time zone, or Modification of printing
language on the Set-up mode section.
4- Check that required incubation temperature is correct. To
change it, press button for 3 seconds. Lights corresponding
to 37 ºC and 60 ºC will start blinking, indicating that the
Do not place any biological indicator in read
positions until the incubator does not confirm
temperature stability.
The incubator will keep running the incubation program during
all reading process. The system does not allow the incubation
program to be modified once the reading is started, except it
has been completed.
6- Reading can be initiated when the temperature blue light
remains stable indicating that incubation temperature was
met. Then an automatic testing of the status of the incubation
positions of the biological indicators will be performed. The
indicating lights of each position will be turned on to show the
result: green light will show a satisfactory result while red light
will indicate error.
When the device detects an error in any position, it will print
a ticket indicating date, time and positions with error. To
guarantee the reliability of the results, these positions will be
deactivated avoiding their use. To make this clear, red light in
that position will remain blinking indefinitely to indicate that the
position has been disabled.
For the correct performance of the automatic check,
it should be done with the protective cover closed.
Read SCBI´s instructions for use. Before placing
the vials in the incubator, press the top to seal
the tube. Crush the internal ampoule (using the

Bionova®MiniBio Page 9
The Bionova®MiniBio allows verifying the remaining incubation
time in every reading position by ticket printing. Whenever a
reading process is in course, press and hold the button for 3
seconds, a ticket will then be printed informing reading position,
incubation program and remaining incubation time.
To verify remaining incubation time of 2 or more readings in
course press 2 buttons simultaneously; the device renders a
ticket informing remaining incubation time of all positions.
Remaining incubation time
Instructions for use
The positive control should belong to the same batch
of the processed SCBI.
Positive Control
POSITIVE CANCELEDNEGATIVE
ampoule crusher within the box of SCBIs or the one
located within the incubation area of the incubator)
and make sure that the liquid has completely wet the
spore carrier placed at the bottom of the biological
indicator plastic tube.
Do not remove or change placement of SCBI once
the reading process has begun. If this occurs,
results may be invalidated.
Use a non-sterilized biological indicator as a
positive control every time a processed indicator is
incubated. For more information refer to the Positive
Control section of this user guide.
7-Place the rapid SCBI in a reading position, close the protective
cover and wait for the result. Reading will start automatically.
Immediately after placing the SCBI in a position, Bionova®
MiniBio Auto-reader will emit a sound alarm indicating that
reading has successfully began and status position light will
turn on and will blink until the result is informed.
NOTE: If the incubator does not run automatically, it might
indicate that the incubator temperature is not steady yet
(check the temperature indicating light to remain steady)
or that the incubation position is disabled due to an error
in the initial autotest.
8- When a positive result is detected, the red light and the
audible alarm will turn on. This will indicate that the sterilization
process to which the SCBI was subject, has failed. 30 seconds
after removing the SCBI from the incubation position, the alarm
and the red light will turn off automatically and the position will
be available to start a new reading.
The negative SCBIs will be informed with a green light in the
corresponding position, this will indicate that the sterilization
process to which it was subject has been successful. The
green light will remain on for up to 30 seconds after the SCBI is
withdrawn from the reading position.
The incubator will inform results within 20 min. (60° C), 30
min. (60 ºC),1 h. (60 ºC), 2 hs. (60 °C), 3 hs. (60 ºC) or 4 hs.
(37 ºC), according to the program selected. These periods of
incubation are the time-limits used by the equipment to inform
the fluorescence final readout.
9- Every time a positive result is detected, it will be informed
through the printing of the corresponding ticket and with an
audible alarm. The alarm can be cancelled by pressing the
button .
10- To register the tickets, take the paper and press up for the
paper to be cut with the serrated edge of the printer.
NOTE:If the paper for ticket printing is finished, the attention
blue light will flash rapidly. To replace the paper, follow the
instructions in Replacing the roll paper in the printer. The
incubator will save the last 3 results, for re-printing, follow
the Reprinting of the last results instructions.

Bionova®MiniBio Page 10
Use a non-sterilized biological indicator as a
positive control every time a processed indicator
is incubated.
Incubate the processed biological indicator and
the indicator used as positive control as long as
specified in the instructions.
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.
Interpretation of results
Instructions for use
Dispose SCBls after use, according to your healthcare and
safety regulations. Positives SCBIs can be sterilized (see SCBIs
instructions for use). It is not possible to reuse a SCBIs.
Disposal
An audible alarm will sound every time a positive result is
detected in the Bionova®MiniBio incubator. The alarm allows
the user to immediately detect a positive result without the need
to visually control the equipment. The alarm can be cancelled by
pressing the button .
When a SCBI is removed from its position during incubation
process, an audible alarm will sound to indicate that the tube
should be returned to the corresponding position.
If the indicator is not re-introduced into the reading position
after 10 seconds of being withdrawn, the reading will be
cancelled and the cancelation will be informed through the
printing of a ticket.
Cancellation of a reading
Audible alarm
The Bionova®MiniBio incubator contains an internal
temperature control. If the temperature falls outside of the
specified range (37±2) ºC or (60±2) ºC, the blue temperature
led light will start to twinkle.
Temperature can be externally monitored by using a Bionova®
TB-IC1020 thermometer or other similar. The Auto-Reader
MiniBio has a special hole for placing the thermometer which is
located at the right side of the device.
Temperature monitoring
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
position of the Bionova®MiniBio incubator. The positive control
should belong to the same batch of the processed SCBI.
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
fluorescence generation.
•Proper functioning of Bionova®MiniBio incubator.
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 . A processed SCBI with a
positive result, indicates a failure in the sterilization process. A
negative result, (green light ) after 20 min. (60 ºC), 30
min. (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.
Take action on any positive result immediately. Always retest
the sterilizer and do not use the sterilizer for processing loads
until 3 consecutive SCBI 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 humidified 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, as it is shown in Instruction of Use of SCBIs. If
the sterilization process was successful, the media will remain
unchanged.

Bionova®MiniBio Page 11
The printer uses thermal paper rolls.
Instructions for use
Setup Mode
Bionova®MiniBio has a setup mode from which, the equipment
time zone and the print language can be set up. To enter Setup
mode, turn on the incubator while holding down the button .
The red and green LEDs in the three positions will remain on,
indicating that the device is in this mode. The printer will render
a ticket indicating that it is in Setup Mode.
To change the time zone and the print language, follow the
instructions below. When finished, restart the computer to exit
Setup mode.
Replacement of the paper roll
Thermal paper specifications
Recommended paper: JUJO AF50KSE3 or similar (order code
ICTP).
Paper width : 58 mm
Maximum paper thickness: 60 g/m2
Maximum diameter size: 23 mm
1. To replace the paper roll,
pull the handle of the printer’s
door. Open the printer’s cover
and remove the spent roll.
2. Place the new paper roll
with the outer side up.
3. Close the printer cover by
pressing on the sides of the
lid.
NOTE:You can check the correct paper replacement
by pressing , this button will force the advance of
the paper a few centimeters.
The incubator allows reprinting of the last 3 results by
fluorescence readout. For printing the results, press the button
for 3 seconds.
Reprinting of results
NOTE: Remember that it is possible to synchronize
the time with the Bioupdate®software and Bionova®
Traceability Software.
Modification of time zone
The time zone modification function allows changing the time
zone of the device to suit the time zone of your country.
To make this change, the incubator must be started in Setup
mode (see Setup Mode), then press the button .
The current time will be printed to set a reference.
To subtract hours, press the button as many times as
necessary. To add hours, press the button as many times as
necessary. After 2 seconds, a ticket will be printed informing the
selected time.
To confirm the change hold down the button for 3
seconds. To discard the changes, unplug the incubator from
the power source.
Modification of printing language
This functionality allows changing the language in which the
incubator printer renders the tickets.
To make this change, the device must be started in Setup mode
(see Setup Mode), then press the button .

Bionova®MiniBio Page 12
Time setting mode
Maintenance
Firmware update
Additional features
Update process
Cleaning and maintenance
Cleaning and decontamination of external surfaces
Modification of the time using the Bioupdate®Software
Connect the auto-reader via the USB port to a PC and start-up
the program. Select the Bionova®MiniBio Auto-reader and press
the Clock Sync button, the auto-reader will be synchronized with
the PC's clock. Synchronization can only be done as long as there
is not an ongoing reading.
Change the time using the Bionova®Traceability Software
Connect the auto-reader via the USB port to a PC and start-
up the program. The Bionova®MiniBio Auto-reader will be
synchronized with the PC's clock. Synchronization can only be
done as long as there is not an ongoing reading.
Disconnect the power supply cable and the USB cable from
the incubator. If the device is hot, wait until it has cooled down
before handling it.
Clean the external surfaces of the device using a microfiber
cloth moistened with a solution of mild dish washing detergent
and water. Wring the cloth so it is damp but not dripping
before cleaning, and wipe the outer surfaces of the incubator.
Afterwards, moisten a clean microfiber cloth with water
only, and repeat the procedure until all traces of detergent
are removed from the external surfaces of the device. After
cleaning, allow the Incubator to air dry for at least 1 hour before
connecting the power supply cable or the USB cable again.
This cleaning procedure can be followed whenever considered
appropriate.
The current language and list of available languages will be
printed to establish a reference. Press the button to scroll
up and to scroll down. After 2 seconds, a ticket will be
printed informing the selected language.
To confirm the change, press and hold the button for 3
seconds. To discard the change, unplug the incubator from the
power source.
This cleaning procedure must be followed every time a spill
occurs on any of the external surfaces of the incubator.
If further cleaning is required, or if you have doubts about
the cleaning agents you may use, please contact your local
distributor.
Bionova®MiniBio does not require routine maintenance.
Bionova®MiniBio Auto-reader Incubator allows the update of
its firmware (program inside the Incubator that controls and
defines its different features) by using the firmware update
utility Bionova®Bioupdate. Bionova®Bioupdate connects to
the internet to verify, download, and install, the latest firmware
version available for your incubator. The update process only
lasts a few seconds and is carried out without the loss of any
Incubator’s data. Please visit www.terragene.com.ar/software
to download Bionova®Bioupdate.
Before updating the device, make sure that the Bionova®
Traceability Software is closed. Power Off the Incubator for five
seconds, afterwards Power On the Incubator and follow the
next steps:
1. Using the included USB cable, connect your Bionova®MiniBio
to a PC where Bionova®Bioupdate has been previously installed.
Make sure the PC has a working internet connection.
2. Run Bionova®Bioupdate.
3. Select the Incubator from the list and press the Start button
to update.
4. Wait until the software indicates that update process has
been completed. The Incubator will print an update confirmation
ticket. If it was already up to date, the ticket will not be printed.
Do not clean the internal parts of the device.
Do not pour or immerse the device into any liquid.
Do not allow any liquid to run inside the device
during its cleaning.
Additional features

Bionova®MiniBio Page 13
Bionova®Traceability Software is a proprietary software
designed by Terragene®to manage and store the results of Self-
contained biological indicators and Hygiene Monitoring System
Indicators in a secure and user-friendly way.
Bionova®Traceability Software allows matching the information
of an Indicator result with the sterilizer or washing machine used,
the operator, cycle characteristics, and all relevant information
for allowing each institution achieve reliable documentation
compliance and safe-keeping. All saved information is stored
in a password protected encrypted database to assure its
integrity. Furthermore, all previously saved information can be
reprinted at any time to generate a hard copy of the results.
Visit www.terragene.com.ar/software to download the latest
version of Bionova®Traceability Software, its User Manual, and
to check its newest features and capabilities.
To use Bionova®Traceability Software along with your incubator,
please download the software from our webpage and install
it in a compatible Personal Computer (PC). The PC minimum
requirments are listed in the Traceability Software User Manual.
After the installation is complete, connect your Bionova®MiniBio
via the USB port to the PC and run Bionova®Traceability Software.
NOTE: This process must be repeated every time that a
new firmware version is available, this will be informed
in the Terragene®S.A. website.
Bionova®Traceability Software
Managing results with Bionova®Traceability Software
Using Bionova®Traceability Software
Additional features

Bionova®MiniBio Page 14
Troubleshooting
The incubator does not start.
The Incubator informs an error in an
incubation position during “Autotest”.
The Incubator informs an error in an
incubation position during “Autotest”.
An incubation can not be run in a
SCBI incubation position (position’s
red light is on).
The Incubator does not run an
incubation in any position.
Is not possible to change temperature
and/or time setting.
The printer does not print (blue
attention light blinks quickly).
The printer releases unprinted paper.
The Incubator can not be updated.
the Incubator is not detected by
Bionova®Traceability Software.
Power supply is not connected.
A indicator is placed in the incubation
position during the Autotest.
Dust particles might be obstructing
the readout mechanism.
Position disabled. Error in that position
during “Autotest”.
Incubation temperature not stable.
Ongoing reading.
The printer cover is not tightly closed.
Printer without paper.
Paper roll is not placed correctly.
Bionova®Traceability Software is
being run.
the Incubator is turned off / incubator
is not connected to the PC.
Check that the power supply is connected to
a proper mains. Check that the DC plug of
the power supply is connected to the rear of
the Incubator.
Check that every incubation position is
empty during the Autotest.
Avoid using the Incubator in dusty
environments. Use air to dust-off inside a
position. Do not insert solid objects. Once
cleared, restart the Incubator.
Make sure that the position is empty when
starting the Incubator. Once cleared, restart
the Incubator.
Wait until temperature is stable before any
incubations.
Wait for any incubation to complete, and try
again.
Check that the cover is tightly closed.
Place a new paper roll in the right direction.
Place the paper according to the directions
on the Replacement of the paper roll section.
Close Bionova®Traceability Software and
restart the Incubator.
Follow the directions on the Start-up section
to set-up the device properly.
Fault Possible cause Action

Bionova®MiniBio Page 15
Terragene®S.A. guarantees both the quality of the product
material components and the quality of its manufacturing
process. Should any material or manufacturing faults be
detected within the warranty period (1 year from the time of
purchase), the only obligation of Terragene®S.A. will be product
repairing or substitution.
Limitation of liability
Technical assistance
Terragene®S.A. shall not be held liable for any loss or damage
that may result from the unsuitable use of the equipment,
negligence or user’s full responsibility.
Terragene®S.A
Ruta Nacional Nº 9, Km 280 - CP 2130.
Parque Industrial Micropi- Alvear-Santa Fe-Argentina.
Warranty

Innovación en tecnologías para el Control de Infecciones
Rev.8 | Mayo 2020
MiniBio
Advertencia: este producto contiene caucho natural seco.
para Indicadores Biológicos
Rápidos, Súper Rápidos y Ultra Rápidos
Auto-lectora

Indice
Composición ..................................................................................................................................................................... 20
Descripción de uso................................................................................................................................................................................................20
Indicaciones de uso..............................................................................................................................................................................................21
Referencias.............................................................................................................................................................................................................21
Información de seguridad .................................................................................................................................................. 21
Símbolos .................................................................................................................................................................................................................21
Condiciones de operación...................................................................................................................................................................................22
Especificaciones de la fuente de alimentación.....................................................................................................................................22
Condiciones ambientales de operación..................................................................................................................................................23
Cumplimiento de normas y directivas..............................................................................................................................................................23
Compatibilidad de productos y programas de incubación...........................................................................................................................23
Programas de incubación para Auto-lectora MiniBio..........................................................................................................................23
Indicadores compatibles con Auto-lectora Bionova® MiniBio ..........................................................................................................23
Número de serie y lote....................................................................................................................................................... 24
Instrucciones de uso ......................................................................................................................................................... 24
Puesta en marcha.................................................................................................................................................................................................24
Tiempo restante de incubación..........................................................................................................................................................................25
Control positivo......................................................................................................................................................................................................26
Interpretación de los resultados ........................................................................................................................................................................26
Descarte..................................................................................................................................................................................................................26
Alarma sonora........................................................................................................................................................................................................26
Cancelación de una lectura.................................................................................................................................................................................26
Monitoreo de temperatura ..................................................................................................................................................................................27
Especificaciones del papel térmico...................................................................................................................................................................27
Reemplazo del rollo de papel..............................................................................................................................................................................27
Reimpresión de resultados .................................................................................................................................................................................27
Modo Configuración.............................................................................................................................................................................................27
Modificación de hora............................................................................................................................................................................................28
Limpieza y mantenimiento..................................................................................................................................................................................28
Características adicionales................................................................................................................................................ 28
Actualización del firmware..................................................................................................................................................................................28
Software de Trazabilidad Bionova®...................................................................................................................................................................29
Tabla de solución de problemas......................................................................................................................................... 30
Garantía ............................................................................................................................................................................ 31
Limitaciones de responsabilidad .......................................................................................................................................................................31
Asistencia técnica.................................................................................................................................................................................................31

Bionova®MiniBio Pág. 20
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2
34
5
6
La Auto-lectora Bionova®MiniBio ha sido diseñada para la
incubación y lectura automática de Indicadores Biológicos
Autocontenidos Terragene®(SCBIs por sus siglas en inglés)
Rápidos, Súper Rápidos y Ultra Rápidos apropiados para el
control de una amplia gama de aplicaciones de esterilización.
La Auto-lectora MiniBio permite dos temperaturas diferentes
de incubación, 37°C ó 60°C. Los microorganismos contenidos
en los SCBIs varían según el proceso de esterilización para
el que han sido diseñados, por lo tanto, las temperaturas de
incubación y los tiempos de incubación varían según el SCBI
que usted pretenda utilizar. La Auto-lectora Bionova®MiniBio
permite la selección de tiempos de incubación independientes
para cada una de sus posiciones.
Los SCBIs para Óxido de Etileno (OE) deben incubarse a 37 ºC,
mientras que los utilizados para el monitoreo del resto de los
procesos de esterilización deben incubarse a 60 ºC.
Descripción de uso
Composición
17
16
18
7
8
9
11
12 13
10
14
15
Consulte la sección Compatibilidad de productos y programas de
incubación para obtener más información sobre los programas
de incubación y los nuevos indicadores disponibles para su
Auto-lectora MiniBio.
La Auto-lectora Bionova®MiniBio permite la detección fácil
y rápida de SCBIs positivos y negativos utilizando técnicas
avanzadas de fluorescencia. Un resultado positivo también se
puede evidenciar por el cambio de color del medio de cultivo al
realizar incubaciones extendidas. Lea las instrucciones de uso
de cada SCBI para más información. La opción de realizar o no
una incubación extendida depende de los protocolos internos
de cada laboratorio u hospital.
La Auto-lectora Bionova®MiniBio también proporciona un
ticket impreso cada vez que se completa una incubación para
registrar los resultados. Esto permite una sencilla gestión
de resultados, para facilitar el cumplimiento de requisitos de
documentación y de integridad de registros.
No es posible la incubación simultánea de
SCBIs para el monitoreo de procesos de OE
conjuntamente con SCBIs para el monitoreo de
otros procesos de esterilización.