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5. General Recommendations
This section includes some general recommendations for your unit.
5.1 Temperature Monitoring
IMPORTANT NOTE
We recommend the use of a redundant and independent temperature monitoring system so that
the device can be monitored continuously for performance commensurate with the value of the product stored. Please
use the probe in glycerin bottle (if present) as the temperature reading reference point for all calibration / validation
procedures.
5.2 Intended Use
The -30°C plasma freezers described in this manual are intended for the storage of blood and blood products in a
frozen state. All materials stored in these products must be in sealed blood bags. Product must not be stored in
open containers. These products are intended for storing samples or inventory at operating temperatures
between -35°C and -18°C.
Expected users of this equipment include but are not limited to personnel from the following areas: Professional
and clinical (blood bank) laboratories, Pharma and Biotech facilities, Industrial and Government facilities or those
trained in laboratory protocols put in place at your facility. The units are not for use by the general public.
These products should only be used by authorized and adequately trained personnel.
It is considered a medical device and has therefore been registered with the medical device regulatory body FDA and
is considered a Class 1 medical device by the FDA. This product is classified as product code
JRM, regulation number
862.2050 and is considered 510(K) exempt
. This unit is not intended for use in classified hazardous locations,
nor to be used for the storage of flammable or corrosive inventory.
Storage of unsealed corrosive substances may cause the interior of the unit to corrode.
Blood bags and blood products CANNOT be stored together with other materials (drugs, reagents and generic use
substances). Blood and blood components must be stored in accordance with the temperature settings recommended
by the manufacturer and must follow general guidelines around suitable storage period.
