Bionova®
TERRAGENE S.A. · Model BT221
Self-contained Biological Indicator for monitoring steam sterilization processes
Intended use: A sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device.
Key tips
- ·A no-signal/flatline alarm gets checked on the patient first, not the monitor - rule out a real clinical event before troubleshooting.
- ·Recalibrate NIBP against a reference manometer, not just a self-test pass.
- ·Reused patient cables (SpO2, ECG leads) are a common source of intermittent-fault complaints - swap the cable before the module.
PM Checklist
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
- ·Routine cable and lead-wire inspection for fraying/wear
- ·Battery conditioning cycle
- ·NIBP calibration check against a reference manometer
- ·ECG / SpO2 accuracy verification against a patient simulator
- ·Annual electrical safety test
Technical Specs
- Storage Environment Temperature
- 10°C to 30°C
- Storage Environment Humidity
- 30 Percent (%) Relative Humidity to 80 Percent (%) Relative Humidity
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- No
- Single use
- Yes
- Prescription use
- OTC
- FDA distribution status
- In Commercial Distribution
- Device type (GMDN)
- Biological sterilization indicator
- FDA product classification
- Indicator, Biological Sterilization Process
- Manufacturer support
- +5493415587007 · info@terragene.com
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- ICU / CCU
- Emergency Department
- OR / PACU
- General med-surg floors
- Step-down units
- Telemetry units
Documents & Manuals
No documents available for this device yet.
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