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Bionova® IC10/20FR 

9

incubating an exposed SCBI. Please refer to the sterilizer 
instructions for use for more information.

If a negative result is obtained when incubating an exposed SCBI 
(green light

), this indicates that the sterilization process 

to which the SCBI was exposed has been successful. This result is 
valid if a positive result is obtained for the positive control SCBI.

!

A positive result should always be obtained by the incubator 
when incubating a positive control SCBI. Refer to the 

Positive 

control

 section for more information.

Positive control

A positive control is a non-sterilized SCBI used as a reference 
during the incubation process. The use of a positive control is 
a recommended practice as it helps to ensure:

 The correct incubation temperature is reached.
 Viability of spores has not been altered due to improper 

storage temperature, humidity, or proximity to chemicals.

 The aptitude of the media to promote rapid growth and 

fluorescence generation.

 Proper functioning of the incubator.

For  the  incubation  of  a  positive  control  SCBI,  first  press  the 

cap to seal the SCBI and crush the ampoule, making sure 
the media completely wets the spore carrier. Identify the 
control SCBI on its label. Place the positive control in an empty 
incubation position and incubate as described in the SCBI 
instructions for use.

!

The positive control and the exposed SCBI should belong to 
the same batch.

Disposal

Discard the SCBIs according to your country’s sanitary 
regulations. Positive SCBIs can be sterilized before discarding 
following the SCBI instructions for use. It is not possible to use 
or incubate an SCBI more than once.

Reprinting of results

The auto-reader allows reprinting of the last 13 results. For 
printing the results, press the   button for 5 seconds.

Audible alarm

An audible alarm will sound every time a positive result is 
detected by the incubator. The alarm allows the user to 
immediately detect a positive result without the need to 

 

Instructions for use

visually check the device. The alarm can be canceled by 
pressing the   button.

Temperature monitoring

The Bionova

®

 IC10/20FR Auto-reader features an automated 

internal temperature control. If the incubation temperature 

falls outside of the specified range of 37 ± 2 ºC or 60 ± 2 ºC, the 

temperature stability indicator light will start to blink.

The incubation temperature can be externally monitored 
by placing an external thermometer in the hole for external 
temperature control located at the back of the device.

Thermal paper specifications

Recommended paper: JUJO AF50KSE3 or similar (order code 
ICTP).

Paper width : 57 mm

Maximum paper thickness: 60 g/m

2

Maximum diameter size: 50 mm

Replacement of the paper roll

1|To replace the paper roll, pull the handle of the printer’s 
door.

2|Open the printer’s cover and remove the spent roll.

3|Place the new paper roll with the outer side up.

Summary of Contents for IC10/20FR

Page 1: ...WARNING this product contains dry natural rubber Rev 31 February 2022 Bionova IC10 20FR Auto reader for Rapid Super Rapid and Ultra Rapid Biological Indicators and Hygiene Monitoring systems...

Page 2: ......

Page 3: ...results 9 Audible alarm 9 Temperature monitoring 9 Thermal paper specifications 9 Replacement of the paper roll 10 Set up mode 10 Date format and time zone selection mode 11 Time setting mode 12 Print...

Page 4: ...of the sterilization processes should be incubated at 60 C Simultaneous incubation of SCBIs for monitoring EO processes along with SCBIs for monitoring other sterilization processes is not possible Pl...

Page 5: ...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...

Page 6: ...he user Operating conditions Power supply specifications Input parameters Operating conditions Units Voltage range 100 240 Volts Frequency 50 60 Hertz Current 0 2 Amperes Output parameters Values Unit...

Page 7: ...selection mode Press again to select the desired temperature After 4 seconds the temperature modification will be accepted automatically 5 Select the appropriate incubation time for the SCBI you are p...

Page 8: ...efore the selected time limit as part of its normal operation Please refer to the Product compatibility and incubation settings section for more information When a negative result is detected in a rea...

Page 9: ...se The positive control and the exposed SCBI should belong to the same batch Disposal Discard the SCBIs according to your country s sanitary regulations Positive SCBIs can be sterilized before discard...

Page 10: ...here are three types of date format DD MM YY MM DD YY and YY MM DD Press the or button to move back and forth between each of the 3 available options After 2 seconds a ticket with the selected format...

Page 11: ...C and start up the program Select the Bionova IC10 20FR 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...

Page 12: ...button To decrease Instructions for use ten minutes value press button Note Possible values for ten minutes are 0 1 2 3 4 and 5 Minutes setting Unit minutes hh mM Press button to turn on the blue ligh...

Page 13: ...dications detailed on Threshold Mode selection on Bionova Cloud Environment section All devices are manufactured with the following settings Default Threshold Mode HTM 01 01 Default Protein Threshold...

Page 14: ...alues selected on your Auto reader Please refer to the Interpretation of results of PRO1 indicators section for more information After a Readout result is informed remove the indicator from the incuba...

Page 15: ...otein level upper limit of acceptable protein contamination after processing is 5 g BSA equivalent per instrument side indicating as well that lower levels may be recommended for particular applicatio...

Page 16: ...ce area to obtain a readout result in g cm2 that can be comparable with the selected Alarm and Alert thresholds also in g cm2 Once the protein quantity in the sample has been obtained by the Auto read...

Page 17: ...pplication and the Bionova Cloud Agent which is a Microsoft Windows App that acts as an interface between the Terragene compatible devices and the web based application Bionova Cloud Traceability Soft...

Page 18: ...and swabbing surface data in cm2 informed by the Surface Eye App throughout the Bionova Cloud Environment allows the creation of ratios of protein quantities and swabbing surface area in g cm2 that ca...

Page 19: ...on The APP will upload all the surface information to your Bionova Cloud Environment account Bionova Cloud Environment 8 The surface acquisition details can be edited from the Apps home menu swiping t...

Page 20: ...nd the protein quantities that correspond to the alert and action thresholds for the defined swabbing area Bionova Cloud Environment Cleaning and maintenance Cleaning and decontamination of external s...

Page 21: ...The printer cover is not tightly closed Printer without paper Paper roll is not placed correctly Bionova Cloud Agent is running on the PC The Auto reader is turned off The Auto reader is not connected...

Page 22: ...The warranty period for electronic products marketed by Terragene will be 1 one year from the date of first use of the product and may never be extended beyond the product s useful life 5 five years f...

Page 23: ......

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