BIOLOGICAL INDICATOR READER / INCUBATOR (MiniBio)
Valid Article
OC subscriptions: included in supply or field order tools (e.g. UniField)
|
|
SC subscriptions: included in supply or field tools
|
|
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)
|
|
BIOLOGICAL INDICATOR READER / INCUBATOR (MiniBio)
Definition
A mains electricity (AC-powered) device designed to accept a biological sterilization indicator (bacterial spores) and to rapidly indicate whether adequate sterilization conditions have been achieved by testing the resistance of the biological indicator previously exposed to a sterilization process (e.g., by steam, or chemical sterilization). It is a bench-top unit intended to provide suitable incubation conditions for the biological indicator and to detect fluorescent enzymatic signals that correlate with the resistance of the biological indicator.
Specifications
The Auto‑reader is designed to incubate and automatically read Ultra Rapid Readout Biological Indicators, BT224, at 60°C for a final fluorescent result at 20 minutes. Biological indicators (BIs) from other brands are not compatible with this device and cannot be used.
Incubation period: 20 minutes
Components
- incubator
- power supply
- usb cable
- digital thermometer
- quick start guide
Technical specifications
- 3 positions for rapid fluorescence readout self-contained biological indicators:
- 38mm deep
- 9mm diameter
- 1 ampoule crusher
- special hole for external thermometer
- incorporated top cap
- dual temperature system: allows selcting between two different incubation temperatures 37°C and 60°C
- USB connection for registering results in a PC through Reading and Traceability Software
- thermal printer to record results
- sound alarm for event indication
- detection and automatic cancellation of the fluorescence reading of the biological indicator
- fluorescence reading wabelength: 460 nm
- power supply
- Voltage Range100‑240 Volts AC
- Frequency 50/60 Hertz
- Power: 28 W
- Output: 12VDC 4A
- operating conditions
- temperature 15– 30°C
- telative humidity: 35-85%
- working temperature 37°C or 60°C +/-2°C
Dimensions
105 x 156 x 145 mm
To be Ordered Separately
- ESTEBIRT0201 BIOLOGICAL INDICATOR, steam, air-remov., BT224
- ESTETBOD1-- TEST, BOWIE-DICK, ready to use pack, s.u.
- ESTETSTI51- TST INDICATOR STRIP, Type 5
Instructions for use
Product Use: Incubation of BI
Use the MiniBio Auto-Reader to incubate Biological Indicator BT224.
Frequency:
- should be used for routine monitoring of steam sterilization cycles at least weekly, preferably daily, each time the autoclave is used
- in every load containing implants (All loads that contain implantable devices - that are implanted in the Operating Theatre and remain in the patient for at least 30 days)
Precautions for Use
- Do not pour any liquid inside
- Do not immerse into any liquid
- Only for indoor use
- Disconnect the power cord before cleaning
- Do not use abrasive or corrosive cleaners or disinfectants
- Make sure that the incubator is connected to a properly rated power cord
Maintenance
The Auto-reader does not require routine maintenance.
Storage
- temperature between 5 and 40°C
- relative humidity: 30-80%
- keep in a dark place
- shelf life: 5 years
Waste management
Recycle electronic equipment
| P410 | Protect from sunlight. |
| P210 | Keep away from heat/sparks/open flames/hot surfaces. – No smoking. |
MSF requirements
Included as part of the Quality Assurance test for the new Tuttnauer autoclave Class B.
Are required:
- ESTEBIRE02- BIOLOGICAL INDICATOR READER / INCUBATOR (MiniBio)
- ESTEBIRT0201 BIOLOGICAL INDICATOR, steam, air-remov., BT224
- ESTETBOD1-- TEST, BOWIE-DICK, ready to use pack, s.u.
- ESTETSTI51- TST INDICATOR STRIP, Type 5
The sterilization procedure should be monitored routinely by using a combination of mechanical, chemical, and biological indicators (BIs) to evaluate the sterilizing conditions and indirectly the microbiologic status of the processed items.
BIs measure the sterilization process directly by using the most resistant microorganisms (i.e., Bacillus spores); they are designed to demonstrate whether the conditions during a steam (autoclave) cycle were adequate to achieve a defined level of microbial inactivation.
![[ESTEBIRT0201] BIOLOGICAL INDICATOR, class B steam, BT224](/web/image/product.template/587587/image_256/%5BESTEBIRT0201%5D%20BIOLOGICAL%20INDICATOR%2C%20class%20B%20steam%2C%20BT224?unique=905b0cf)
![[ESTETBOD1--] TEST, BOWIE-DICK, ready to use pack, s.u.](/web/image/product.template/569669/image_256/%5BESTETBOD1--%5D%20TEST%2C%20BOWIE-DICK%2C%20ready%20to%20use%20pack%2C%20s.u.?unique=481c0f1)
![[ESTETSTI51-] TST INDICATOR STRIP, Type 5](/web/image/product.template/572358/image_256/%5BESTETSTI51-%5D%20TST%20INDICATOR%20STRIP%2C%20Type%205?unique=62132a6)