B medical systems MT100, Instructions For Use Manual

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2.4 Intended use
2.4.1 Intended Purpose
Blood refrigerator/incubators 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, or platelet components between
20°C to 24°C, until they are ready for use. They are electrically-powered devices and include an active
system to regulate the temperature, handles and/or wheels for transportation, and alarms which signal
unintentional changes in temperature and power failures.
2.4.2 Intended Target Users
Pharmacists, doctors, laboratory staff or other staff that are trained and/or experienced in dealing with
whole blood and blood components.
Blood refrigerator/incubators 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, as well as platelet components. The organization must implement and validate
procedures for the storage and distribution of blood and blood components, as well as platelet 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 blood
refrigerator/incubators.
Patients do not come into direct contact with the devices.
2.4.3 Intended Use Environment
Blood refrigerator/incubators are intended to operate indoors in hospitals, blood donation services, blood
transfusion centers and clinical laboratories, or outdoors during transport inside vehicles.
The devices are designed for an ambient temperature range from -2°C to +43°C under operation, and from
-30°C to +70°C during transport and storage. The ambient humidity range during transport and storage lies
between 5% and 95%, and up to 75% under operation.
2.4.4 Indications
Blood refrigerator/incubators are intended for the safe transport and storage of whole blood and blood
components, as well as platelet components, used in the clinical medicine for diagnosis, prevention and
treatment of diseases or injuries. The transport and/or storage duration of platelet components must not
exceed 24 hours.
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).
During a maximum transit time of 24 hours, the temperature of whole blood or other blood components
must at no time 10°C. Temperature excursions above +10°C increases the risk of sepsis due to
bacterial contamination.