The safety standards developed by B Medical Systems define unique technical characteristics, guaranteeing the safe storage of preparations and establishing the highest safety standards for the user.
This instrument complies with national and international guidelines and regulations for Medical Devices. It offers reliability, efficiency and safety at an optimal price.
- Storage capacity (350ml plasma bags): 460
- Cold/hot temperature alarm limit: -46°C / -32°C
- Medical Device according to MDR (EU) 2017/745, Class IIa
- Wide range of functions and accessories
ACCURATE TEMPERATURE AND 24 HOURS GUARANTEED
- Controlled air cooling system for uniform and stable temperature distribution
- Automatic defrost with stable temperature maintenance
- Quick temperature recovery even after numerous door openings
- Safety thermostat to prevent freezing
- Long autonomy in the event of a power failure
- Acoustic and visual alarms with remote notification via SMS or email
- °B Connected universal software for remote archive, report (FDA 21 CFR Part 1 compliant
EFFICIENCY
- High efficiency natural gas compliant with US SNAP and F-GAS
- High performance and low consumption compressor
- One-piece printed polypropylene chassis guaranteed for life against corrosion and fully recyclable
CONVENIENCE
- Easy access to parameters via 7 'touch-screen
- Card reader for reserved entrance or with password
- Data export via USB or card reader
- Anti-bacterial coating for the best cleaning
- Low noise
- Low heat emission
- Modular interior equipment
- Easy access to internal drawers-trays
- Highest quality stainless steel
- Set Point -41°C
MULTIFUNCTIONAL ELECTRONICS FOR MAXIMUM RELIABILITY
- Multi-function electronics
- Audio-visual alarm system with remote transmission in case of unexpected temperature changes and power failure
- Compatible with universal '°B Software' connected for remote monitoring, recording and long-term archiving
- Electronic temperature recorder
- USB port for easy export of recorded data
- Data backup battery
DESIGN OPTIMIZED FOR ENERGY EFFICIENCY
- Often polypropylene insulation, without corrosion and with perfect thermal insulation, 100% recyclable
- Minimized cold air loss
- Ecological refrigerant R290
- Ecological footprint reduced to a minimum
IMPROVED STRUCTURE AND BUILT FOR ETERNAL DURABILITY
- Anti-corrosion structure guaranteed for life
- Constructed by rotational molding, in high quality polypropylene for better insulation and strength
- No sharp edges for easier maintenance and cleaning
- Ergonomic design for safe use at all times
FIRST-CLASS EQUIPMENT
- European Medical Device Regulation: MDR (EU) 2017/745, Class IIa (models: 220-240 V - 50/60 Hz & 230 V - 50 Hz)
- EMC directive: 2014/30 / EU (models: 220-240 V - 50/60 Hz & 230 V - 50 Hz)
- Low voltage directive: 2014/35 / EU (models: 220-240 V - 50/60 Hz & 230 V - 50 Hz)
- FDA regulation-Medical Device: 21CFR Part 864.9700, Class II (models: 115-127 V - 60 Hz & 220 V - 60 Hz)
- cCSAus certificate: Yes (models: 115-127 V - 60 Hz & 220 V - 60 Hz)
- GMP - Clean room classification: Class ISO 6 / EC GMP B Class ISO 5 / EC GMP A
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