The Smart-Max device has multiple functions *:
1. Preparing cellular products for cryopreparation with automated mixing and cooling technology
2. Preparing cellular products for infusion by dry thawing of frozen products
3. Adding reagents such as cryoprotectant or dilution media at a controlled rate into cellular products
4. Potential to be used in incubation, digestion, and other cell therapy applications

The Smart-Max is a hands-free device designed for safe and reproducible procedures. It allows multiple units of various sizes to be connected at once. A data storage and transfer function allows the traceability of each unique unit. Injection rates/volumes/times, temperatures, and compatible bag information is available per Smart-Max protocol.

 

Smart-Max Features

 

Dimensions	W: 27 cm, L: 32 cm, H: 17 cm (10.6” x 12.6” x 6.7”) 8.5 kg (18.7 lbs)
User interface	Color touch screen display (640×480 pixels), Graphical User Interface
Communication	Windows 7 Embedded, CAS, USB and Ethernet
Core technology	Mechanical platform cooled or heated by a Pelletier module, pneumatic circuitry for mixing and electrical motor for pumping and infusing
Traceability	Barcode reader with multiple code reading capabilities and desktop printer Procedure data management with pdf report and procedure graph
Product volume capacity	200 ml

 

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Unique Features

• USB ports to connect printer, barcode scanner, memory sticks and other usual PC interfaces.
• LAN, WLAN integration.
• User selectable multi-language support.
• Enhanced traceability features (e.g.: collect patient file via USB).
• Pneumatic mixing technology for optimal product mixing during reagent infusion.
• Universal cooling plate for small and large volume blood bags.
• Possibility of cooling down to 1°C and heating up to 50°C.
• 2 peristaltic pumps for DMSO infusion, parallel infusions possible.
• Possibility to inject DMSO in two cryobags at the same time (dual platform).
• Remote access possibility via internet.

 

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Main Components

• The mechanical platform for cooling and heating
• The pneumatic cuff bags for mixing
• The peristaltic pumps for the injection of biological additives

 

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Safety and Performance

Smart-Max complies with the directive 93/42/CEE for medical devices, including the electrical safety standard IEC 60601-1.

 

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Storage Requirements

The Smart-Max should only be operated on a flat, horizontal and clean surface with enough surrounding space to allow proper ventilation and operation procedures. The Smart-Max must only be used/ stored under the following environmental conditions:

 

	Operation	Storage and Transport
Temperature	+7°C to +27°C	0°C to 50°C
Relative humidity	30% to 75%, non-condensing	20% to 75%, non-condensing
Maximum altitude	2000m, 80kPa	2000m, 80kPa

 

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