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Terragene BIONOVA MiniBio User Manual

Terragene BIONOVA MiniBio
48 pages
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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

Table of Contents

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Terragene BIONOVA MiniBio Specifications

General IconGeneral
CategoryBiological Indicator Incubator
ModelMiniBio
BrandTerragene
Dimensions65 x 90 x 90 mm
Weight150 g
Incubation Time24 hours
DetectionVisual
DisplayNo
ConnectivityNo

Summary

Composition

Product Description

Describes the Bionova MiniBio Auto-reader's design and function for incubating and reading biological indicators.

Safety Information

Indications for Use

States the purpose of Terragene Bionova Reader Incubators for specific temperature incubation and reading of indicators.

References

Lists numbered components and their descriptions for the Bionova MiniBio Auto-reader.

Symbols

Explains various symbols used in the manual and on the device, covering warnings and operational indicators.

Safety Precautions

Provides essential warnings and guidelines to prevent risks and device damage during operation.

Operating Conditions

Power Supply Specifications

Details the input and output voltage and current requirements for the Bionova MiniBio Auto-reader.

Environmental Operating Conditions

Environmental Conditions

Outlines acceptable environmental parameters such as altitude, temperature, humidity, and voltage for operation.

Device Safety Compliance

Electrical Safety

Lists compliance standards for electrical safety, including IEC 61010 and Low Voltage Directive.

Electromagnetic Compatibility

Details compliance with EMC Directive and EN 61326-1 standards for electromagnetic interference.

European Commission

Mentions compliance with RoHS and WEEE Directives, and photobiological safety standards.

Product Compatibility and Incubation Programs

Bionova® MiniBio Incubation Programs

Lists available incubation programs and advises checking country-specific indications for use.

Bionova® MiniBio Auto-reader Compatible Indicators

Directs users to a website or QR code for checking compatible indicators.

Serial/Batch Number

Explains where to find and register the incubator's serial and batch numbers for identification.

Instructions for Use

Start-up

Guides users through the initial setup and power-on procedure for the Bionova MiniBio Auto-reader.

Temperature and Time Setting

Explains how to set the incubation temperature and select time programs for the device.

Instructions for Use

Reading Process and Results

Details how the incubator reads indicators and indicates positive or negative results via lights and alarms.

Remaining Incubation Time

Describes how to check and print the remaining incubation time for active reading positions.

Positive Control

Emphasizes the importance of using a positive control and its batch matching.

Instructions for Use

Interpretation of Results

Explains how to interpret rapid readout results and visual readout results.

Disposal, Alarm, and Cancellation

Covers SCBI disposal, audible alarms, and cancellation of readings.

Temperature Monitoring

Explains internal temperature control and how to monitor it externally.

Thermal Paper Specifications

Replacement of the Paper Roll

Provides step-by-step instructions for replacing the thermal printer paper roll.

Setup Mode

Modification of Time Zone

Explains how to change the device's time zone using the Setup Mode.

Modification of Printing Language

Details how to change the printer's language setting via Setup Mode.

Additional Features

Time Setting Mode

Explains how to set the time using Bioupdate® Software or Traceability Software.

Cleaning and Maintenance

Provides instructions for cleaning external surfaces and general maintenance advice.

Firmware Update

Guides users on how to update the incubator's firmware using the Bioupdate utility.

Bionova® Traceability Software

Managing Results

Describes how the software manages and stores biological indicator results securely.

Using Bionova® Traceability Software

Explains how to download, install, and use the software with the incubator.

Troubleshooting

Incubator Not Starting

Addresses issues with the incubator not powering on, including possible causes and actions.

Incubation Position Errors

Details common errors related to incubation positions during autotest and how to resolve them.

Printer Issues

Covers problems with the printer not printing or releasing unprinted paper, with solutions.

Software Detection Issues

Explains how to resolve issues where the incubator is not detected by the Traceability Software.

Warranty

Limitation of Liability

States Terragene S.A.'s limitations of liability regarding equipment use.

Technical Assistance

Provides contact information for technical support from Terragene S.A.