BHY Hyper Auto-Reader Incubator

The BHY Bionova Hyper Auto-Reader Incubator is a cutting-edge accessory designed for the incubation and readout of Hyper Rapid Self-Contained Biological Indicators. It is an essential tool for professionals in healthcare, food, pharmaceutical, and medical device industries who prioritize accuracy, efficiency, and compliance in infection control protocols.

Usage

This incubator is specially designed for the Bionova™ Hyper Rapid Biological Indicators (BT98 – VH₂O₂). It features a fluorescence system that enables readout after 5 minutes of incubation at 60°C, ensuring rapid and reliable results.

Key Characteristics

Readout Positions:

• Two positions (38 mm deep, 9 mm diameter) for simultaneous incubation at 60°C.

Integrated Features:

• 1 ampoule crusher for easy biological indicator processing.
• Dedicated hole for an external thermometer.

User Convenience:

• Automatic detection and cancellation of readout if indicators are removed prematurely.
• Audible alarms for event notifications.
• Unique ID for each result to enhance audit traceability.
• Stores up to the last 50 results for quick access.

Connectivity:

• USB, Wi-Fi, and Bluetooth technology for seamless data sharing.
• Fully compatible with Bionova™ Cloud Traceability Software and the Terragene Wireless Assistant App.

Advanced Features:

• Fluorescence reading wavelength: 460 nm.
• Easy firmware updates by the user.

Technical Specifications

• Dimensions: 107 mm (H) x 97 mm (W) x 103 mm (D)
• Voltage Range: 100–240 VAC
• Power: 18W
• Frequency: 50-60 Hz

Compliance and Safety Standards

The BHY Bionova™ Hyper Auto-Reader Incubator meets stringent regulatory and safety standards:

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

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

Electromagnetic Immunity & Compatibility:

IEC 60601-1-2, EN 60601-1-2

EN 61326-1, EN 62311

Directives:

RED Directive 2014/53/EU

RoHS Directive 2011/65/EU

WEEE Directive 2012/19/EU

FDA Clearance: FDA 510(k) K221641

Environmental Conditions

Manufacture Conditions:

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

Storage Conditions:

• Temperature: 5–40°C
• Relative Humidity: 30–80%
• Store in a dark place.

Transport Conditions:

• Recommended to follow storage conditions.
• Acceptable excursions:

T = 2–5°C or 40–65°C for no longer than 7 days.

No restrictions for relative humidity.

Shelf Life and Packaging

Shelf Life: 5 years.

Packing Details:

• 1 unit per box.
• Includes product code, description, operation conditions, and manufacturer information.

Labelling

Labelling is provided on both the product and packaging, including:

• Product code and description.
• Operating conditions.
• Batch number, serial number, barcode, and manufacturer details.

Precautions

• Avoid pouring or immersing the incubator in any liquid.
• Use indoors only.
• Disconnect the power cord before cleaning.
• Avoid abrasive or corrosive cleaners.
• Use only the included power supply and cables.

The BHY Bionova™ Hyper Auto-Reader Incubator is the perfect choice for fast, reliable, and efficient biological indicator processing. With its advanced features and compliance with international standards, it ensures optimal infection control practices in a variety of settings.