Terragene Bionova IC10/20FRLCD User manual

Rev.5 | November 2018
IC10/20FRLCD
Innovation in technologies for Infection Control

IC10/20FRLCD Page 3
Protective Cover.
Touch Screen Display
Incubation area for 12 BIs. Protein Pen Detection.
BIs ampoule crusher.
1
2
3
4
5
6
7
8
9
10
Thermal Printer
Indicator Light for Paper Replacement
and Printer Functioning.
Paper’s Traction Button.
Cavity for Paper.
12 volt DC Input.
Hole for External Temperature Control.
Ethernet port (RJ45).
References
Composition
8
9
10
5
6
2
1
4
7
3

IC10/20FRLCD Page 4
Bionova® IC10/20FRLCD Auto-reader has been desig-
ned for the incubation of the following Self-Contained
Biological Indicators (IBs):
• Rapid Readout Self-Contained Biological Indicators:
BT110 for Ethylene Oxide sterilization control, BT220
and BT221 for Steam sterilization control, BT102 for
Formaldehyde sterilization control and BT95 for Plasma
or Vaporized Hydrogen Peroxide sterilization control.
• Super Rapid Readout Self-Contained Biological Indi-
cators: BT222 and BT223 for Steam sterilization control
and BT96 for the control of Plasma or Vaporized Hydro-
gen Peroxide sterilization control.
• Ultra Rapid Readout Self-Contained Biological Indica-
tors: BT224 for Steam sterilization control.
Microorganisms contained within the Biological Indi-
cators vary depending on the sterilization process for
which they have been designed, therefore, incubation
temperatures dier depending on the indicator. Indica-
tors for Ethylene Oxide (EO) sterilization control, should
be incubated at 37 ºC, while those involved in the mo-
nitoring of the rest of the sterilization processes should
be incubated at 60 ºC.
Simultaneous incubation of BIs for EO proces-
ses control within BIs monitoring the other pro-
cesses, is not possible.
Bionova® IC10/20FRLCD Auto-reader allows easy and
rapid detection of positive and negative Biological In-
dicators. Six incubation programs are available: 4 hours
at 37 ºC, 3 hours at 60 ºC, 2 hours at 60 ºC, 1 hour at 60
ºC, 30 minutes at 60 ºC and 20 min. at 60 °C.
A positive result can also be evidenced by culture me-
dium color change to yellow, read the instructions for
use of each 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 laboratory or hospital.
The IC10/20FRLCD Bionova® Auto-reader contains
a special cavity to run quantitative readings of the
Chemdye® PRO System.
The equipment can be connected to a PC through an
Ethernet port. This allows to link the results with the Bio-
nova® Traceability Software for Automatic Readout and
Traceability of Rapid, Super Rapid, Ultra Rapid Biological
Indicators and Hygiene Monitoring System. To down-
load the latest version of the software, go to: http://
www.terragene.com.ar/productos/infection-control/
incubators/software-downloads/.
Description of use
PRO icon
Positioning icons
Screen References
Main screen
Composition
Status position light
Date and Time
Temperature stability ligths
Alarm icon
Temperature icon
Results history icon
Remaining time icon
Bionova® icon
Start PRO icon
Program conguration icon
13:34 hs.
25/02/16
Network connection indicator /
Bionova connection indicator
Cancel PRO icon
Settings for all positions icon
37 60

IC10/20FRLCD Page 5
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.
Symbols
Operating relative humidity.
Operating environmental temperature.
Caution, warning.
Caution: Risk of electric shock.
Caution: Hot surface.
Important, attention.
Manufacturer.
Serial number.
Direct current.
Product denomination.
80 %
30 %
10 ºC
30 ºC
REF
To reduce the risk of using incompletely ste-
rilized loads:
-Make sure to use each BI with its incubation
and reading program:
BT110 (green top) with 4 hs. (37 ºC) 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
BT224 (aquamarine top) with 20 min. (60 ºC)
program
BT102 (red top) with 2 hs. (60 °C) program
BT95 (white top) with 2 hs. (60 °C) program
BT96 (grey 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-
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.

IC10/20FRLCD Page 6
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 IC10/20FRLCD Auto-rea-
der has a unique serial number and a batch number
printed on a label found at the bottom of the au-
to-reader 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: manufactory rmware is printed on a label found
on the bottom of the auto-reader and on its packaging.
Date Version Operator
Please, register your manufactory rmware in this ma-
nual for future reference:
Manufactory Firmware:
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
0 - 50
12
Units.
Meters
ºC
%
°C
DC volts

IC10/20FRLCD Page 7
Instructions for use
Start-up
To change it, press the icon . A screen will be displa-
yed with the incubation program options:
Select the desired option. This conguration will be
stored for that temperature until the user resets it.
A change of incubation program can be made
only in the empty positions.
The auto-reader will keep the selected tempera-
ture (37 ºC or 60 ºC) during the reading process.
The system does not allow to modify the tem-
perature once the reading process has begun,
unless the reading is nished.
Since there is only one incubation program for
37 °C temperature, it will be automatically se-
lected for all positions when this temperature is
selected. Once selected the temperature of 60
°C again, the auto-reader will remember the last
incubation program used in each position for
that temperature.
5-Once the selected temperature has been reached
and remains stable, after turning on the equipment, a
one-time automatic check of the Biological Indicators
and Protein Pen incubation positions will be carried
out. Indicating lights of each position will turn on brin-
ging the result, a green light will show a satisfactory
result while a red light will indicate error.
When the equipment detects an error in any position,
a ticket indicating the day, time and position involved
will be printed. These positions will be deactivated,
thus preventing their use.
For a correct automatic check, the protective co-
ver of the auto-reader should be in its place and
all the positions empty.
Read BIs instructions for use. Before placing the vials in
the auto-reader, press the top to seal the tube. Crush
the ampoule (using the ampoule crusher within the
box of BIs or the one located within the incubation area
of the auto-reader) and make sure that the liquid has
completely wet the spore carrier placed at the bottom
of the biological indicator plastic tube.
1-Place the auto-reader on a rm surface, free from vi-
brations, away from sunlight, currents of hot or cold air,
chemicals and corrosive or ammable substances. Do
not place the equipment in a way that disconnection
of the plug from the power supply could be dicult.
Leave a gap of at least 10 cm from the wall. Do not
move the auto-reader periodically or during its use.
Connect the auto-reader to a secure and stable elec-
trical power source.
Do not wet or heat the auto-reader. If liquid is
spilled on the auto-reader, disconnect it and dry
it immediately. Before turning on, verify that all
reading positions are empty.
2-Turn on the machine by connecting the end of the
AC power supply to the mains and then connect the
other end of the source (plug) on the rear of de IC10/
20FRLCD unit. The printer’s paper light will turn on,
if this light becomes intermittent, this means that
thermal paper must be loaded or that the printer co-
ver is not tightly closed. Otherwise, the light remains
stationary.
3-Enter Website of the equipment and set language,
time zone and clock (see Settings located into Website
of the equipment section).
All equipment is manufactured with the fo-
llowing settings:
- Time zone: UTC +0:00
- Printing language: English
If you wish to change language or time zone, go to Set-
tings located into Website of the equipment.
4- Select incubation program and desired temperature
for each readout position.
Bionova® IC10/20FRLCD allows the selection of
dierent incubation programs for each one of
the readout positions.
It also allows to congure the same program
for the 12 positions simultaneously. To do this,
press the icon . It will change its appearan-
ce to when simultaneous conguration is
possible. For this, no position must have a rea-
dout in progress.
The device will start by taking the last incubation pro-
gram and temperature settings used. To change the
incubation temperature, press icon for 3 seconds
to select 37 ºC or 60 ºC as appropriate. A screen will be
displayed informing that temperature has changed.
The incubation temperature can be modied
only when there is no reading program in pro-
gress.
To select an incubation program for each of the po-
sitions you must press the icon of the corresponding
position, ex. . A screen will be displayed informing
the current program of that position:

IC10/20FRLCD Page 8
Do not remove or change placement of BI 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 indica-
tor is incubated. For more information refer to
the Positive Control section of this user guide.
6-Place the rapid BI in a reading position and wait for
the result. Reading will start automatically. Immedia-
tely after placing the BI in a position, the auto-reader
IC10/20FRLCD will emit an audible alarm to indicate
that the readout started and will show the informa-
tion screen of the initiated position. Status position
light will turn violet and will blink until the result is
informed.
NOTE: If the auto-reader does not run automatically,
it might indicate that the auto-reader temperature is
not steady yet (check the temperature indicating li-
ght to remain steady) or that the incubation position
is disabled due to an error in the initial autotest.
When a BI is removed from it's position du-
ring incubation process, an audible alarm will
sound to indicate the tube should be returned
to the corresponding position.
If the indicator isn’t re-introduced into the rea-
ding position after 10 seconds of being with-
drawn, the reading will be cancelled and the
cancelation will be informed through the prin-
ting of a ticket.
7-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 BI was subject,
has failed. 30 seconds after removing the IB from the
incubation position, the alarm and the red light will
turn o automatically and the position will be availa-
ble to start a new reading.
The negative BIs 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 BI is withdrawn from the
reading position. The auto-reader 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 uorescence nal readout.
8-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 .
9-To register the tickets, press the button for paper
traction, take the paper and pull to cut it with the se-
rrated edge of the printer.
Instructions for use
Positive control
Interpretation of results
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 specied 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®
IC10/20FRLCD Auto-reader.
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
and the generation of uorescence.
-Proper functioning of Bionova® IC10/20FRLCD Au-
to-reader.
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 positive control shows a positive result .
A processed BI with a positive result indicates a failure
in the sterilization process. A negative result (green
light ) after 20 min. (60 °C), 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 eective.
The presence of positive results indicates a steriliza-
tion process failure may have occurred and implies
that the load must be reprocessed immediately. Fa-
cing these results, verify good practices for load pre-
paration and usage of biological indicators. Check the
volume of the load to be sterilized as well as the BI’s
Make sure that the reading position you want to
use is congured with the incubation program
corresponding to the biological indicator you
want to analyze.
NOTE: If the paper runs out, the light of paper repla-
cement will start blinking (see Replacement of the pa-
per roll in the printer).

IC10/20FRLCD Page 9
Disposal
Hygiene monitoring system
Instructions for use
Dispose Bls after use, according to your healthcare
and safety regulations (see BIs instructions for use).
position inside the load. In case the BI has been co-
rrectly used, it should be interpreted that it is likely
that the sterilizer has failed and maintenance is re-
commended.
Visual Readout
The Rapid readout system allows the conrmation of re-
sults by color change after 48 hours or 7 days incubation
analysis (if 7-day incubation is performed, an humidied
environment will be required to avoid media dry out).
If the sterilization process was not successful, the cul-
ture medium in the indicator will turn to yellow, as
shown in the BIs Instructions for Use. If the steriliza-
tion process was successful, the indicator medium will
remain unchanged.
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.
Chemdye®PRO1 MICRO reading system
Chemdye® PRO1 MICRO's incubation position allows
the quantitative analysis of products destined to the
cleaning and contamination control.
The IC10/20FRLCD can run a quantitative analysis of
the PRO1 MICRO Hygiene Monitoring System, adjus-
ted using a BSA (Bovine Seric Albumin) standard cur-
ve. This analysis ensures the traceability of the control
of surface cleaning.
The method has a detection limit of 1 µg and a sensi-
tivity of 0.3 μg.The result is indicated with a resolution
of 0.1μg, and its accuracy is ± 0.5μg (IC95%), in the
range of 0 to 5μg, and ±0.7μg (IC95%), in the range of
5 to 10 μg with a range of 10 μg.
Readings will be able to initiate once the incuba-
tion temperature has been selected and is stable.
The lights corresponding to the selected tempe-
rature (37 ºC or 60 ºC) will blink until the tem-
perature is reached, and then stay stable. PRO1
MICRO readings must be performed at 60 °C.
Reading process
1-Press icon . Then, the following screen will be
displayed:
2-Use PRO1 MICRO pen to collect the sample of the
surface to be analyzed. To do this, follow the instruc-
tions described in Figure 1 (Also explained in the ins-
tructions for use of PRO1 MICRO).
3-Once the solutions contained within the device
have been correctly mixed, proceed with incubation
(remember that the reading cone must not contain
the swab). For this, insert the pen on the incubation/
reading position (Figure 2). Make sure to place PRO-
1MICRO as it is indicated on the auto-reader label. In-
sert the pencil making sure that it stops at the bottom
of the reading position, if it is in the correct position,
check that it cannot be rotated (Figure 2).
4-Press icon to start the incubation and reading
process (15 minutes at 60 ºC). The equipment will re-
turn to the main screen and the PRO status position
light will remain blinking until the reading ends.
If for any reason the reading needs to be can-
celled before it ends, PRO position should be
re-entered by pressing icon . Then, press
icon for 3 seconds. The reading will be can-
celled and its corresponding ticket will be prin-
ted.The equipment will display the main screen
automatically.
Do not move or remove the pen from its position
during the reading process, this can cause erro-
neous readings or even cancellation of the same.
If the auto-reader detects that the protein pen
has not been placed properly in the reading
position, a ticket will be printed indicating:
"Pen not detected. Check result visually".
It is not possible to reuse an already incubated
protein pen.
5-Once the incubation process is complete, an audible
alarm indicates the end of the program. The sample
is read and the protein value is calculated based on a
BSA (Bovine Seric albumin) calibration/standard cur-
ve. Then, the auto-reader will print a ticket conrming
the calculated protein concentration. If the value is
below the selected threshold, a green light will
appear, indicating a negative result, if it is by above
the selected threshold, a red light will appear,
indicating a positive result. In both cases, one of the
lights of the PRO panel will indicate the approximated
rank of concentration calculated between 1 to 5 µg; if

IC10/20FRLCD Page 10
Instructions for use
Figure 1
Remove swab from
the device. Carefully
apply 2 drops of
moisturizer on the
swab.
Swab thorougly the
desired surface.
Place swab back into
the device.
Press the swab
downwards rmly to
activate.
Slide swab upwards.
Shake downwards
vigorously until the
solution turns to
green.
Slide swab
downwards.
Shake for 15 seconds.
Slide swab upwards.
Shake vigorously and
collect solution
in the readout cone.
Readout cone
without swab
the value exceeds the 5 µg all the lights on the panel
will light up. The threshold to determine a positive or
negative result can be congured using the Biono-
va® traceability software. The conguration process
is outlined in the Bionova® traceability software ma-
nual. The factory-set threshold is 1µg.
To visualize the displayed protein value on the screen,
press the icon .
Finally press to return to the main screen.
NOTE: 30 seconds before the end of the program, the
auto-reader will emit an alarm that will last until the
reading is complete, notifying the operator that the
incubation time will be fullled. The color of the so-
lution can be used for a qualitative reading only if the
pen is removed once the program nalizes. If the pen
is not removed at that time, the color of the solution
will continue to evolve.

IC10/20FRLCD Page 11
Instructions for use
Figure 2
Insert the pen in the
incubation/reading
position.
Impossible
to rotate
Impossible
to rotate
Incubate and read.
1/K
1/L
Results history visualization
Audible alarm
The auto-reader is equipped with several alarm functions
that indicate dierent states after the incubation.
In the case of the biological indicators, an alarm will go
o whenever the Bionova® IC10/20FRLCD Auto-reader
emits a positive result. This will allow the user to imme-
diately 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 o 30 seconds befo-
re the program cycle ends and will last until the reading
is complete, notifying the operator that the incubation
time will be fullled.The color of the solution can be used
for a qualitative reading only if the pen is removed once
the program nalizes. If the pen is not removed at that
time, the color of the solution will continue to evolve.
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 dis-
played 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).
Cancelling a reading
Temperature monitoring
The Bionova® IC10/20FRLCD Auto-reader contains an in-
ternal temperature control. If the temperature falls out-
side of the specied range (37±2 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. IC10/
20FRLCD Auto-reader has a special hole for placing the
thermometer which is located at the back of the device.
When a BI is removed from it’s position during incuba-
tion process, an audible alarm will sound to indicate the
tube should be returned to its corresponding position.
If the indicator is not returned to the reading position
within 10 seconds from its removal, the reading will
be canceled and the auto-reader will print out a ticket
conrming the cancellation.
In the hygiene monitoring system, the user can cancel
the reading by pressing the button of the cho-
sen position and the button for three seconds. The
device will cancel the reading and the auto-reader will
print out a ticket conrming the cancellation.
Replacement of the paper roll
The printer uses thermal paper rolls.
Thermal paper specications
1. Pull the handle of the
printer’s door.
2. Open the printer’s
cover and remove the
spent roll.
Recommended paper: JUJO AF50KSE3 or similar (or-
der code ICTP).
Paper width : 58 mm
Maximum paper thickness: 60 g/m2
Maximum diameter size: 50 mm
After reading, discard the hygiene indicators accor-
ding to the sanitary regulations of your country. The
hygiene indicators used cannot be reused (read the
Instructions for use of Chemdye® PRO1 MICRO Hygie-
ne Monitoring System).
Disposal

IC10/20FRLCD Page 12
Network cable specications
Care and cleaning
The use of a category 5 UTP cable with RJ45 connec-
tors for Ethernet networks is recommended.
Firmware update
Clean the exterior surface of the Bionova® IC10/
20FRLCD Auto-reader with a damp cloth moistened
with a small amount of detergent. Do not clean inte-
rior components. If additional cleaning of the wells is
required, contact your distributor or manufacturer.
Always unplug the IC10/20FRLCD Auto-reader
and allow it to cool before cleaning. Do not im-
merse the unit in liquid.
NOTE: Bionova® IC10/20FRLCD does not need routine
maintenance.
Instructions for use
4. Close the printer co-
ver by pressing on the
sides of the lid.
Remaining incubation time |
Congured programs
Bionova® IC10/20FRLCD Auto-reader allows to verify
remaining time of incubation and the congured pro-
grams of each reading position in a very simple way. To
do this, press on the icon .Then, a new screen will
open indicating the remaining readout time of each
position that is performing an incubation. In positions
where there is no readout initiated, the name of the se-
lected program will be displayed.
Press to return to the main screen or just wait one
minute to return automatically.
IC10/20FRLCD Auto-reader allows updating the r-
mware periodically (program that controls the device
and denes its diferent functionalities) through the
use of the Bioupdate Software. This software veri-
es, by using the internet, the latest rmware version
available for IC10/20FRLCD Auto-reader; downloads it
and installs it in a few seconds without the loss of any
device data.
The Bioupdate Software must be downloaded, only
once, from the following web site: http://www.terra-
gene.com.ar/productos/infection-control/incuba-
tors/software-downloads/.
Download le:
To ensure the proper functioning of the Bioupdate
software, before starting the update procedure, make
sure:
- That the Bionova® software is closed. Turn o the
computer for 5 seconds and turn it on again.
- Connect your PC and the auto-reader to the same ne-
twork, preferably through the specied network cable.
Avoid connections of the PC and the auto-reader to
the network through Wi.
- That the rewall and the PC Anti-Virus do not block
the execution of the Bioupdate software.
UPDATING PROCEDURE:
1-Connect the auto-reader to the same network that
your PC is connected through a specied Ethernet ca-
ble and make sure you have an internet connection.
2-Verifythattheconnectionindicatoronthemainscreen
changes from to . This indicates that the
auto-reader has a connection to the network. Enter the
auto-reader Information screen by pressing .
3-Open the Bioupdate program.
4-Select the equipment you want to update, check that
the IP is correct. Press the Start button to update.
5-Wait until the software indicates that the update pro-
cess has been completed. The auto-reader will issue a
ticket indicating the new Firmware version.
NOTE: This process must be repeated every time a new
version of Firmware is available, which will be informed
on the website.
3. Place the new paper
roll with the outer side
up.

IC10/20FRLCD Page 13
In any web browser (from a connected device to the
same network as the auto-reader) enter the following
address: http://xxx.xxx.xxx.xxx. The “X” characters re-
present the IP number reported on the device. Then,
the equipment's website homepage will open.
On this screen you will be able to see the status of each
of the positions as well as the remaining incubation
time of those in the middle of a reading process. Also,
from this screen, you will have access to the history of
results and settings .
You can access this page from the homepage or from
any other page, by clicking on the icon . On this page
you will nd the history of the last 208 results grouped
by 10 per page. By clicking on Previous or Next, you will
be able to scroll all the results that are stored in chro-
nological order.
You can access this page from the homepage or from
any other page, by clicking on the icon . On this page
you will nd language conguration, time zone and
time. These parameters can be congured and synchro-
nized immediately with the auto-reader.
Homepage | Status screen
Results history
Settings
The IC10/20FRLCD Auto-reader has an internal website
that allows knowing in real time and remotely the sta-
tus, conguration and history of results of the device.
You can access the website from any mobile device,
tablet or PC connected to the same network as the au-
to-reader. To access, you must rst know the IP address
that the router in your network has assigned to the au-
to-reader. For this, you must press the icon
on the main screen. A screen will be displayed where
the batch and serial number of the equipment and its IP
address will be informed, besides other data.
Website of the equipment
Calibration
Time setting mode
Modication of the time using the Bioupda-
te® Software
Connect the auto-reader to the same network as your
PC using a specic Ethernet cable and start the pro-
gram. Select the Bionova® IC10/20FRLCD 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®Tracea-
bility Software
Connect the auto-reader to the same network as your
PC using a specic Ethernet cable and start the pro-
gram. The Bionova® IC10/20FRLCD Auto-reader will be
synchronized with the PC's clock. Synchronization can
only be done as long as there is not an ongoing reading.
The calibration procedure of the equipment is des-
cribed in the attached software manual ("Bionova®
Traceability Software for Automatic Reading and Tra-
ceability of Rapid, Super Rapid and Ultra Rapid Bio-
logical Indicators and Hygiene Monitoring System").
You can also download it by going to http://www.
terragene.com.ar/productos/infection-control/incu-
bators/software-downloads/. You can check that the
equipment is connected to theTraceability software if
the Connection Indicator changes from to .
NOTE: When it is necessary to update the graphical en-
vironment, the update process may take 30 minutes or
more. This will be notied with a message to the user
from the Bioupdate software.

IC10/20FRLCD Page 14
Fault Possible cause Action
The auto-reader does not start
The auto-reader gives an error in
one position during“Autotest”.
The auto-reader gives an error in
the“Autotest”.
The auto-reader does not run a BI
reading.
The red light of that position is
blinking.
The auto-reader does not run a BI
readout in any position.
The auto-reader does not run
Chemdye® PRO1 MICRO readings.
The red light of that position is
blinking.
When initiating the PRO incuba-
tion program the machine makes
a sound but it does not initiate.
The auto-reader does not allow to
change the incubation program.
The printer does not print and the
printer indicating light blinks.
The printer releases unprinted
paper.
The Bionova® traceability softwa-
re does not detect the auto-rea-
der.
The update of the auto-reader fails.
Power source is not connected.
A BI is placed in the position at the
moment of starting the auto-reader.
Soil particles might be obstruc-
ting the light path between the
sensors.
The autotest gives an error in that
position, which becomes disabled.
The incubation temperature is not
stable.
The autotest gives an error in the
PRO position, which becomes
disabled.
The incubation temperature is not
stable.
Ongoing reading.
The printer cover is not tightly
locked.
Printer without paper.
Paper roll is placed in the wrong
direction.
The auto-reader is turned o or ne-
twork cable is disconnected.
The auto-reader is connected to the
Bionova® traceability software.
The rewall of the PC operating
system prevents the correct func-
tioning of the Bioupdate software.
Some antivirus programs block the
update of the auto-reader when
running the Bioupdate software.
The auto-reader Information screen
is not open.
The connection of the equipment
to the network to which your PC is
connected fails.
Check that the power source is connec-
ted to the power supply and that the
plug is connected to the auto-reader.
Check that every position is empty at
the moment of starting the auto-reader.
Ensure cleanliness of the incubation
position. Use of air is recommended.
Do not use solid objects that could da-
mage internal components. Restart the
auto-reader.
Make sure that the position is empty
when starting the auto-reader. Restart
the auto-reader.
Wait for temperature to be stable.
Make sure that the PRO position is emp-
ty when starting the auto-reader. Res-
tart the auto-reader.
Wait for temperature to be stable.
Wait for the readings to nish.
Check that the cover is tightly closed.
Place a new paper roll in the right direc-
tion.
Check the paper roll direction.
Verify that the equipment is turned on
and the network cable is correctly con-
nected.
Close the program, restart the auto-rea-
der and try again.
Disable the PC's rewall for a moment.
Once the update process is complete,
activate it again.
Disable the Antivirus of your PC for a
moment. Once the update process is
complete, activate it again.
Before starting your update access the
auto-reader Information screen from the
main screen by pressing the Bionova icon.
Connect the auto-reader to the ne-
twork through the specied network
cable. Avoid connecting your PC to the
network through a Wi-Fi connection. A
wired connection to the network is re-
commended. Make sure your internet
service is working correctly.
Troubleshooting chart

IC10/20FRLCD Page 15
Warranty
Terragene® S.A. guarantees both the quality of the
product material components and the quality of its
manufacturing process. Should any material or ma-
nufacturing 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 liable for any loss or da-
mage 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.

Rev.5 | Noviembre 2018
IC10/20FRLCD
Innovación en tecnologías para el Control de Infecciones

IC10/20FRLCD Pág. 18
Composición
Cubierta protectora.
Display táctil.
Área de incubación para 12 IBs. Lápiz de detec-
ción de proteínas. Rompe ampollas para IBs (crus-
her).
1
2
3
4
5
6
7
8
9
10
Impresora térmica.
Luz indicadora recambio de papel y
funcionamiento impresora.
Botón de tracción de papel.
Cavidad para papel.
Entrada de 12 Voltios DC.
Oricio para control externo de temperatura.
Puerto Ethernet (RJ45).
Referencias
8
9
10
5
6
2
1
4
7
3

IC10/20FRLCD Pág. 19
La Auto-lectora IC10/20FRLCD Bionova® ha sido dise-
ñada para la incubación de los siguientes Indicadores
Biológicos (IBs) Autocontenidos:
• IBs Autocontenidos de Lectura Rápida: BT110 para el
control de esterilización por Óxido de Etileno, BT220 y
BT221 para el control de esterilización por Vapor, BT102
para el control de esterilización por Formaldehído y
BT95 para el control de esterilización por Plasma o Va-
por de Peróxido de Hidrógeno.
• IBs Autocontenidos de Lectura Súper Rápida: BT222 y
BT223 para el control de esterilización por Vapor y BT96
para el control de esterilización por Plasma o Vapor de
Peróxido de Hidrógeno.
• IBs Autocontenidos de Lectura Ultra Rápida: BT224
para el control de esterilización por Vapor.
Los microorganismos contenidos dentro de los indi-
cadores biológicos varían de acuerdo al proceso de
esterilización para el cual han sido diseñados, por ello,
las temperaturas de incubación son diferentes según
el indicador. Los indicadores para el control de esterili-
zación por Óxido de Etileno (OE), deben ser incubados
a 37 °C, mientras que aquellos para el control de los
restantes procesos de esterilización deben incubarse
a 60 °C.
No es posible la incubación simultánea de IBs
para el control de procesos por OE junto con IBs
para el control de los demás procesos.
La Auto-lectora Bionova® IC10/20FRLCD permite la
detección rápida y fácil de indicadores biológicos po-
sitivos y negativos. Dispone de 6 programas de incuba-
ción: 4 hs. a 37 °C, 3hs. a 60 °C, 2 hs. a 60°C, 1 h. a 60 °C,
30 min. a 60 °C y 20 min. a 60 °C.
Un resultado positivo también puede evidenciarse a
través del cambio de color del medio de cultivo al color
amarillo, lea las instrucciones de uso de cada indicador
para más información. La elección de realizar o no la
incubación extendida para conrmación por cambio
de color depende de los protocolos internos de cada
laboratorio u hospital.
La Auto-lectora IC10/20FRLCD Bionova® contiene una
cavidad especial para realizar lecturas cuantitativas del
Sistema Chemdye® PRO1 MICRO.
La Auto-lectora IC10/20FRLCD Bionova® no sólo permi-
te la detección de los resultados, también proporciona
un ticket impreso para su registro.
El equipo puede conectarse a una PC por un puer-
to Ethernet. Éste permite vincular los resultados con
el Software de Trazabilidad Bionova® para la Lectura
Automática y Trazabilidad de Indicadores Biológicos
Rápidos, Súper Rápidos, Ultra Rápidos y Sistema de
Monitoreo de Higiene. Para descargar la última versión
del software ingrese en: http://www.terragene.com.ar/
productos/control-de-infecciones/incubadoras/des-
cargas-de-software/.
Descripción de usoPantalla principal
Composición
Referencias de la pantalla
Ícono PRO
Íconos de posición
Luz de estado de posición
Fecha y hora
13:34 hs.
25/02/16
Luces de estabilidad de temperatura
Ícono Alarma
Ícono Temperatura
Ícono Historial de resultados
Ícono Tiempo restante
Ícono Bionova®
Indicador de conexión a la red /
Indicador de conexión a Bionova
Ícono Iniciar PRO
Ícono Cancelar PRO
Ícono Conguración de programa
Icono Conguración de todas las posiciones
37 60

IC10/20FRLCD Pág. 20
Humedad relativa de funcionamiento.
Temperatura ambiente de funcionamiento.
Precaución, advertencia.
Precaución: riesgo de descarga eléctrica.
Precaución: supercie caliente.
Importante, atención.
Fabricante.
Número de serie.
Corriente directa.
Denominación de producto.
Símbolos
Para evitar riesgos y daños en el equipo
-No coloque el equipo en un ambiente expues-
to a la luz solar directa o a lámparas de alta in-
tensidad lumínica.
-No coloque el equipo cerca de dispositivos
que emiten campos electromagnéticos
-No utilice el equipo sobre supercies con vi-
braciones.
-No vierta ningún líquido en su interior.
-No sumerja la auto-lectora en ningún líquido.
-Utilice sólo en interiores.
-Desconecte el cable de alimentación antes de
proceder a su limpieza.
-No utilice limpiadores o desinfectantes abrasi-
vos o corrosivos.
-En caso de algún desperfecto técnico, contác-
tese con el fabricante para su asesoramiento.
Por favor, evite abrir y/o intentar arreglar la
auto-lectora, ya que esto provoca la pérdida de
la garantía y puede ocasionar un desperfecto
mayor e irreversible.
-Asegúrese que la auto-lectora esté conectada
a la fuente de alimentación correspondiente.
80 %
30 %
10 ºC
30 ºC
REF
Información de seguridad
Para reducir el riesgo de utilización de car-
gas no estériles:
-Asegúrese de utilizar cada IB con su programa
de lectura e incubación adecuado:
BT110 (tapa verde) con el programa de 4 hs. a 37 ºC
BT220 (tapa marrón) con el programa de 3 hs. a 60 ºC
BT221 (tapa azul) con el programa de 1 h. a 60 ºC
BT222 (tapa violeta) con el programa de 1 h. a 60 ºC
BT223 (tapa celeste) con el programa de 30 min. a 60 ºC
BT224 (tapa aguamarina) con el programa de 20 min a
60 ºC
BT102 (tapa roja) con el programa de 2 hs. a 60 °C
BT95 (tapa blanca) con el programa de 2 hs. a 60 °C
BT96 (tapa gris) con el programa de 30 min. a 60 ºC
-Verique que el medio de cultivo humecte el
portador con esporas.
-No retire el IB hasta que el equipo informe el
resultado nal de la lectura, compruebe la im-
presión del ticket de resultado.
Para evitar riesgos de lesiones por los frag-
mentos de vidrio que se generan al romper
la ampolla de vidrio contenida dentro del
tubo plástico del IB:
-Deje enfriar el IB durante el tiempo indicado
antes de romper la ampolla.
-Evite la manipulación excesiva del IB antes de
que el mismo se enfríe, ya que esto puede pro-
vocar que la ampolla estalle.
-Utilice gafas y guantes de seguridad al retirar
el IB del esterilizador.
-Utilice gafas y guantes de seguridad al romper
y presionar la tapa del IB.
-No utilice los dedos al romper el IB.
Para evitar potenciales situaciones de peli-
gro: evite contacto con la supercie caliente
del bloque metálico del incubador.
Para evitar que los IBs absorban residuos
uorescentes: evite que los IBs entren en
contacto directo con indicadores químicos o
cintas.
No utilice este producto de manera no especi-
cada por Terragene® S.A., de lo contrario, la pro-
tección proporcionada por el producto podría
verse afectada.
No sustituya el cable de alimentación de la
fuente por otros no provistos con el producto.
Solo personal autorizado por Terragene® S.A.
puede acceder al interior de la auto-lectora y
sus componentes. Ninguna parte o componen-
te del interior del equipo debe ser manipulada
por el usuario.