B medical systems MRB 3000 SDD, Instructions For Use Manual

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2.4 Intended Use
2.4.1. Intended purpose
Ice-lined blood storage refrigerators are devices intended to be used in the blood transfusion medicine
for the support on the diagnosis, prevention and treatment of diseases or injuries by keeping whole blood
or blood components at a protective and stable temperature between 2°C to 6°C until they are ready for
use. The devices comprise an icelined compression cooling system and an integrated alarm system that
warns against unexpected temperature excursions and power failures.
2.4.2. Intended target population
Pharmacists, doctors, laboratory staff or other staff that are trained and/or experienced in dealing with
whole blood and blood components.
The Ice-lined blood storage refrigerators must be operated by individuals in organizations that have the
knowledge of the relevant FDA, AABB, EU or any other applicable regulations on storage and distribution
of blood and blood components. The organization must implement and validate procedures for the
storage and distribution of blood and blood components according to these regulations, including the
necessary storage temperature and the suitable storage period.
Service technicians with a recognized license or certificate as required by local authorities for installation,
servicing and repair of refrigeration systems and equipment, and properly trained on the ice-lined blood
storage refrigerators.
Patients do not come into direct contact with the refrigerators.
2.4.3. Intended use environment
The Ice-lined blood storage refrigerators are stationary type devices and are intended to operate indoors
in hospitals, blood donation services, blood transfusion centers and clinical laboratories.
The devices are designed for an ambient temperature range from +10°C to +43°C under operation, and
from -30°C to +55°C during transport and storage. The ambient humidity range during transport,
storage and operation lies between 5% and 95%.
The devices must not be used outdoors.
2.4.4. Indications
The Ice-lined blood storage refrigerators are intended for the safe storage of whole blood and blood
components used in the clinical medicine for diagnosis, prevention and treatment of diseases or injuries.
Whole blood, red cells, and other blood components intended to be used for transfusion, like leucocyte-
depleted whole blood and red cells, must be kept at a controlled temperature between 2°C and 6°C
during storage and can be stored for a period of time of up to 35 days, depending on the
anticoagulant/preservative solution used.
Long storage of whole blood and blood components above 6°C increases the risk of bacterial
contamination (septicemia), which may progress to septic shock. Septic shock has a death rate as high
as 50%, depending on the type of organism involved, and therefore requires urgent medical
intervention.
The storage of blood and blood components below 2°C increases the risk of rupture of the red cells
(haemolysis).