Plasma freezer F901 by B-Medical-Systems

Introducing the Plasma Freezer F901 from B-Medical Systems' esteemed 'F' PREMIUM series—a pinnacle of advanced technology and precision for plasma storage. Engineered with exceptional quality and equipped with cutting-edge features, this unit stands as an epitome of safety and performance.

UNPARALLELED TEMPERATURE CONTROL AND SECURITY

• Incorporates a controlled air cooling mechanism for consistent and stable temperature regulation.
• Automated defrost system ensures temperature stability is maintained.
• Swift temperature recovery even with frequent door openings.
• Features a safety thermostat to prevent undesired freezing.
• Offers extended autonomy during power outages.
• Equipped with acoustic and visual alarms, including remote notifications via SMS or email.
• Compatible with °B Connected universal software for seamless remote archiving and compliant reporting (FDA 21 CFR Part 11).

SUPERIOR EFFICIENCY

• Complies with US SNAP and F-GAS, utilizing highly efficient natural refrigerant gas.
• High-performance compressor ensuring reduced energy consumption.
• Constructed with a polypropylene chassis—life-long corrosion resistance and fully recyclable.

USER-FRIENDLY CONVENIENCE

• 7-inch touch-screen for intuitive parameter access.
• Card reader offering secured entry or password protection.
• Facilitates data export through USB or card reader.
• Anti-bacterial coating ensures supreme hygiene.
• Operates with minimal noise and heat emission.
• Features modular internal equipment and accessible drawers and trays.
• Constructed with top-grade stainless steel.
• Operational Set Point: -41°C.

PRODUCT SPECIFICATIONS - F901 Plasma Freezer

• Capacity: Holds up to 690 plasma bags (350ml each).
• Temperature Alarm Limits: Low: -46°C; High: -32°C.
• Classified as a Medical Device under MDR (EU) 2017/745, Class IIa.
• Equipped with multifunction electronics featuring a 0.1°C precision touchscreen and monitoring software.

MULTIFUNCTIONAL ELECTRONICS FOR ENHANCED RELIABILITY

• Multifunction electronics system.
• Audiovisual alarm with remote alerts during temperature fluctuations or power outages.
• '°B Software' compatibility for remote monitoring, logging, and data archiving.
• Includes an electronic temperature recorder.
• Easy data export via USB port, backed by a reliable battery for data preservation.

ENERGY-EFFICIENT DESIGN

• Thick, corrosion-resistant polypropylene insulation for optimal thermal efficiency—100% recyclable.
• Minimizes cold air loss to maintain efficiency.
• Utilizes ecological refrigerant R290, sustaining a minimal ecological footprint.

DURABLE CONSTRUCTION

• Life-long corrosion-resistant design.
• Manufactured using rotational molding techniques for enhanced insulation and strength.
• Ergonomically designed without sharp edges for straightforward maintenance and cleaning.

COMPLIANCE AND CERTIFICATIONS

• Compliant with European Medical Device Regulation: MDR (EU) 2017/745, Class IIa.
• Adheres to EMC directive: 2014 / 30 / EU.
• Meets Low voltage directive: 2014 / 35 / EU requirements.
• FDA regulation compliance for Medical Devices: 21CFR Part 864.9700, Class II.
• cCSAus certified.
• Meets GMP - Clean Room Classification standards: Class ISO 6 / EC GMP B, Class ISO 5 / EC GMP A.

The Plasma Freezer F901 reflects B-Medical Systems' unwavering commitment to quality, safety, and innovation in medical storage solutions.