Plasma freezer F381 by B-Medical-Systems

The Plasma Freezer F381 by B Medical Systems represents the pinnacle of innovation in the 'F' Series, seamlessly integrating advanced multifunction electronics with robust safety mechanisms, including an array of alarm systems and reliable battery backup. This system is fully compatible with the °B Connected solution, enabling comprehensive remote monitoring and data logging capabilities.

The unit boasts a durable polypropylene frame, crafted using a one-piece print to ensure lifetime protection against corrosion. B Medical Systems has designed this model to conform to stringent safety standards, offering assured safe storage of plasma preparations while prioritizing user safety at every step.

Compliant with both national and international medical device standards, the F381 ensures reliability, efficiency, and safety, all at an optimal cost. Its specifications include:

• **Plasma Storage Capacity:** Accommodates up to 284 bags of 350ml each
• **Temperature Alarm Thresholds:** -37°C for cold alarms and -27°C for warm alarms
• **Compliance Certifications:** Meets DIN 58375 and AABB Standards, classified as a Medical Device under MDR (EU) 2017/745, Class IIa
• **Precision Electronics:** Features multifunction electronics with a clear 0.1°C display
• **Corrosion Protection:** Life-guaranteed anticorrosion structure

Control Panel Features:

• Multifunctional electronics
• Audiovisual alarm systems with remote transmission capabilities for unexpected temperature fluctuations and power outages
• Compatible with °B Software for remote monitoring, logging, and archiving
• Electronic temperature recorder and USB port for easy data export
• Data backup battery functionality

Design Elements:

• Constructed from thick polypropylene ensuring unparalleled thermal insulation and corrosion resistance
• Equipped with the ecological R290 refrigerant and a minimized ecological footprint
• Ergonomically designed for safe operation, featuring a lifetime-guaranteed corrosion-resistant structure with no sharp edges for simplified maintenance and cleaning

Standard Equipment and Accessories:

• Includes 2 keys for secure door operations
• Lockable electronics
• Automatic fan shutdown upon door opening to prevent cold loss
• Backup battery supports approximately 48 hours of operation
• Acoustic alarms for temperature deviations and general alerts
• Remote and open door alarms
• Sensor input port
• Includes one standard drawer and two adjustable shelves

Regulatory and Compliance Certifications:

• In accordance with European Medical Device Regulation: MDR (EU) 2017/745, Class IIa
• EMC Directive: 2014/30/EU
• Low Voltage Directive: 2014/35/EU
• FDA Regulation-Medical Device: 21CFR Part 864.9700, Class II
• cCSAus Certification: Yes
• GMP Cleanroom Classification: Class ISO 6 / EC GMP B

The Plasma Freezer F381 by B Medical Systems is meticulously engineered to deliver superior performance and reliability, embodying an elegant synthesis of innovative technology and user-centric design.