General Recommendations; Temperature Monitoring; Intended Use - Thermo Scientific TSX Series Installation And Operation Manual

General Recommendations

5 General
This section includes some general recommendations for your unit.
Recommendations
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 an authorized and adequately
trained personnel. It is considered a medical device and has therefore been
registered with the medical device regulatory body FDA.
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.
Thermo Scientific TSX -30°C Plasma Freezers 7