Usage

For incubation and readout of:

Bionova® Rapid Fluorescence Readout Biological Indicators: BT220 (Steam): 3 h at 60 °C, BT221 (Steam): 1 h at 60 °C and BT110 (E0): 4 h at 37 °C, BT102 (Formaldehyde): 2 h at 60 °C, BT95 (VH202): 2 h at 60 °C.

Bionova® Super Rapid Fluorescence Readout Biological Indicators: BT222 (Steam): 1 h at 60 °C, BT223 (Steam): 30 min. at 60 °C, BT96 (VH202): 30 min. at 60 °C.

Bionova® Ultra Rapid Fluorescence Readout Biological Indicators: BT224 (Steam): 20 min. at 60 °C.

Chemdye® Protein Pen system: 7 min. at 60 °C.

Applicable regulation

Designed under Quality Management System standards ISO 13485:2016/NS-EN, ISO 13485:2016.

Low Voltage Directive 2014/35/EU.

Electromagnetic Compatibility Directive 2014/30/EU.

RoHS Directive 2011/65/EU.

WEEE Directive 2012/19/EU.

FDA 510(k) K191021

Characteristics

12 metal positions (3.8 cm deep, 0.9 cm diameter) to incubate Rapid/Super Rapid/Ultra Rapid Fluorescence Readout Self-contained biological indicators, 1 position (3.8 cm deep, 1.3 cm diameter) to incubate Protein Pen, 1 ampoule crusher, 1 special hole for external thermometer.

3.5 ” touchscreen LCD. Visual information of the remaining time of the incubation process.

Temperature display on the screen and remaining time for each position.

Dual Temperature System: Allows selecting between two different incubation temperatures (37 °C y 60 °C). Allows running different incubation times simultaneously, provided they are of equal incubation temperature.

Audible alarm for event indications.

ETHERNET connection for recording results on PC using a Reading and Traceability software.

Remote display of the screen in PC and Smartphones.

It stores the last 208 results.

Thermal Printer of Results. Allows to reprint the last 208 results. Automatic detection and cancelation of biological indicator fluorescence reading.

Firmware update by the user.

Fluorescence reading wavelength: – 460 nm. Dimensions: 18.0 cm high, 26.0 cm diameter. Voltage range: 100 – 240 VAC.

Power: 28 W.

Frequency: 50-60 Hz.

Environmental conditions during manufacture T = 15-30 °C, RH = 35-85 %.

Storage conditions

T = 5-40 °C, RH = 30-80 %, keep in a dark place.

Transport conditions

It is recommended to respect the storage conditions during transport.

Products should be transported in closed and reinforced boxes in order to avoid damages. The transport of this product does not represent any risk for human health.

Acceptable excursions during transport are as follows:

T = 2-5 °C and T = 40-65 °C for no longer than seven days. No restrictions for relative humidity.

Shelf life 5 years.

Packing

1 unit per box.

Packing information: product code and description, storage conditions and manufacturer information.

Labelling

On the product and on product’s box: product code and description, storage conditions, batch number, serial number, barcode and manufacturer information.

Possible target markets

Healthcare, Food, Pharmaceutical and medical devices industries.

Other important information

The IC10/20FRLCD incubator has an automatic readout system and a printer to record data. It also has a history of records to query the last 208 results, which can be viewed from the device screen or remotely accessing the embedded web server.