Photon Biological Incubator Auto Reader Device

The Photon Biological Incubator Auto Reader Device is an advanced, high-precision diagnostic device designed for the rapid incubation and automatic readout of Self-Contained Biological Indicators (SCBIs), specifically for monitoring steam sterilization processes. Utilizing sophisticated fluorescence-based detection technology, the system provides near-instantaneous validation of sterilization efficacy, significantly reducing the quarantine time for processed medical instruments. It serves as a cornerstone for modern infection control departments, offering a digitalized approach to sterilization monitoring that integrates seamlessly into healthcare and pharmaceutical traceability ecosystems.

Features:

• Instantaneous 7-Second Readout: The system utilizes high-sensitivity fluorescence techniques to deliver definitive "Pass/Fail" results in just 7 seconds for compatible indicators (such as the Bionova® BT225), representing one of the fastest biological monitoring solutions available.
• Dual Independent Readout Positions: Features two incubation wells that operate independently, allowing for the simultaneous or staggered processing of different biological indicators without cross-interference.
• Advanced Connectivity and Traceability: Equipped with integrated Wi-Fi, Bluetooth, and USB connectivity, the device enables real-time data synchronization with the Bionova® Cloud web application and mobile assistants for comprehensive electronic record-keeping.
• Integrated Analysis Tools: The unit includes a built-in ampoule crusher to simplify the activation of biological indicators and a dedicated port for an external thermometer to allow for independent temperature verification.
• Standardized Incubation Environment: Maintains a stable incubation temperature of 60 ± 2 °C, optimized for the growth and enzymatic activity of Geobacillus stearothermophilus spores.
• Regulatory and Safety Compliance: FDA cleared (under De Novo classification DEN220042) and manufactured under ISO 13485:2016 standards; the device also complies with IEC 61010-1 electrical safety and EN 60601-1-2 electromagnetic compatibility requirements.
• Compact and Ergonomic Design: Designed with a small footprint (107 mm height x 97 mm width x 103 mm depth) and a digital LCD interface, making it suitable for space-constrained dental clinics and large-scale sterile processing departments alike.

Documents:

• Brochure
  
• Instructions for Use
• Product Classification Decision