BPH Photon AutoReader Incubator: The Ultimate Solution for Sterilization Monitoring

The BPH Photon AutoReader Incubator is a sophisticated device designed for the incubation and readout of Instant Self-Contained Biological Indicators (SCBIs). Developed by Terragene®, it ensures precise and rapid monitoring of sterilization processes, catering to industries like healthcare, food, pharmaceuticals, and medical devices. With cutting-edge features and adherence to stringent regulatory standards, the BPH Photon AutoReader is the ideal solution for maintaining high standards of sterilization.

Key Features and Benefits

Efficient Incubation and Readout

• Operates at a consistent 60 °C for simultaneous incubation of SCBIs across its two independent readout positions (38 mm deep, 9 mm diameter).
• Rapid and reliable fluorescence readout ensures results are delivered accurately.

User-Friendly and Intelligent Design

• Features an ampoule crusher and a dedicated hole for an external thermometer.
• Automatic detection of placed indicators and readout cancellation if indicators are removed prematurely.
• Audible alarms notify users of events, enhancing operational efficiency.

Advanced Connectivity

• Equipped with USB, Wi-Fi, and Bluetooth® technology, ensuring seamless integration with digital ecosystems.
• Compatible with the Bionova® Cloud Web Application and Bionova Wireless Assistant Application for mobile devices.
• Easily update firmware directly through user-friendly tools.

Data Traceability

• Each result is assigned a unique ID number, ensuring robust audit trails.
• Stores up to 50 previous results for easy access and compliance with traceability requirements.

Technical Specifications

Feature Specification

Fluorescence Wavelength 460 nm

Voltage Range 100 – 240 V AC

Power Consumption 18 W

Frequency 50 – 60 Hz

Operating Temperature 40 – 50 °C

Dimensions 107 mm (H) x 97 mm (W) x 103 mm (D)

Shelf Life 5 years

Regulatory Compliance

The BPH Photon AutoReader Incubator adheres to rigorous standards to ensure safety and reliability:

Quality Management System: ISO 13485:2016/NS-EN ISO 13485:2016

Electrical Safety: IEC 61010-1; IEC 61010-2-010

Electromagnetic Compatibility: EN 60601-1-2; EN 61526-1; EN 62511

FDA Clearance: DEN220042 under FDA De Novo classification

Environmental Directives:

ROHS Directive 2011/65/EU

WEEE Directive 2012/19/EU

Environmental and Storage Considerations

Manufacturing Conditions

• Temperature: 15 – 35 °C
• Relative Humidity (RH): 35 – 85 %

Storage Conditions

• Temperature: 5 – 40 °C
• RH: 30 – 80 %
• Keep the device in a dark, dust-free environment.

Transport Conditions

• Acceptable temperature excursions: 2 – 5 °C 40 – 65 °C (for no longer than seven days)

• Transport in closed, reinforced boxes to prevent damage.

Packing and Labelling

Packing Details:

1 unit per box

Includes product code, description, storage conditions, and manufacturer details

Labelling:

Labels on the product and box include product code, batch number, serial number, barcode, storage conditions, and manufacturer information.

Precautions for Use

• Do not pour or immerse the device in liquids.
• Use only the included power adapter and cords.
• Disconnect the power cord before cleaning.
• Avoid using abrasive or corrosive cleaners or disinfectants.
• Intended for indoor use only.

Applications

The BPH Photon AutoReader Incubator is versatile and designed to meet the needs of various industries:

• Healthcare: Ensures the sterility of surgical instruments and equipment.
• Pharmaceuticals: Validates sterilization cycles to maintain product safety.
• Food Industry: Monitors sterility in food processing environments.
• Medical Devices: Guarantees compliance with sterilization standards for sensitive equipment.

Why Choose the BPH Photon AutoReader Incubator?

The BPH Photon AutoReader Incubator offers unmatched reliability and efficiency in sterilization monitoring. Its combination of advanced features, robust connectivity, and compliance with international standards makes it an invaluable asset for industries prioritizing safety and quality.

Upgrade your sterilization process today with the BPH Photon AutoReader Incubator—precision and efficiency at your fingertips.