HEMACOOL
TM
Model HMC-MIL-1 Operations Manual August 2003
Energy Storage Technologies, Inc.
Dayton, Ohio 45459
27
20 Standards Task Details
Temperature Regulation and Display Tracking Test
This test requires placing a calibrated temperature probe into a dummy payload and
measuring the actual payload temperature being maintained by the unit. The temperature
probe may be a calibrated thermocouple for a calibrated thermocouple thermometer. It
may also be a temperature-logging device, such as a Sensitech Temptale™ that has been
calibrated. The dummy payload may be commercial cold packs such as “Kool-Its™” or
“Blue Ice™” or blood bags filled with 30% calcium chloride solution to which 1/8
teaspoon or 0.5 cc of blue food coloring has been added to distinguish the solution from
real blood products. The dummy load must also be
clearly
labeled with its contents, and
in large letters:
NOT FOR MEDICAL USE
.
These tests must not be conducted with a real payload. Real payloads of blood
products require particular temperature ranges. When you switch control points
during this test, the temperature will temporarily go outside safe ranges for any
blood products.
In a room temperature environment, arrange the dummy load in the
HemaCool™
blood
baskets. Place the temperature sensor in the middle of the payload and in intimate
contact with the payload. Set the
HemaCool™
to the
4°C
set point and turn it on. Note
procedures for setting temperature with the “locking toggle” switch, page 9. Allow it to
stabilize with the dummy load for at least 24 hours. After 24 hours of stabilization, if
you are using a thermocouple thermometer, measure the temperature. It should be
between
2°C
and
5°C
± the accuracy tolerance of your thermometer. The displayed
temperature should agree within
1°C
and should not be outside the range of
2°C
and
5°C
.
If you are using a data-logging device, it should be set to log data points every 5 minutes.
The logging device should be placed in the unit at the beginning of the 24 hours