Intended Purpose; Contraindication; Overtemperature Protection - Barkey plasmatherm Instructions For Use Manual

Description of the device
2.4

Intended purpose

The Barkey plasmatherm is a thawing and heating device intended for the following ap-
plications:
timed heating of whole blood and blood products
thawing and timed heating of frozen plasma conserves
thawing and timed heating of HPC (haematopoietic progenitor cells)
heating and maintaining the warmth of non-denaturable infusion solutions and other
materials in continuous operation.
The Barkey plasmatherm can be used whenever it is desirable to prevent the cooling of
patients as a result of transfusions, infusion solutions or other materials.
These summarised statements on the intended use of the device are supplemented in this
instruction manual by specific descriptions of the various different applications and of the
handling of the device. You will find these descriptions in the Chapters Safety advice to
Operation of this instruction manual. Please use these chapters to find specific informa-
tion about usage of the device in individual cases.
2.5

Contraindication

The device must not be used to heat or keep warm animals or to thaw, heat or keep warm
objects or fluids of any kind except those as described under „Intended purpose‟.
There are no known contraindications when thawing and/or heating blood and blood
products.
2.6

Overtemperature protection

Independent overtemperature protection systems monitor the temperature of the device.
In the event of a fault or if an overtemperature limit is reached, the device's heating is
switched off, the yellow LED in the display and operating panel lights up and a continu-
ous alarm tone sounds.
Should this occur, switch off the device or disconnect the mains plug and wait for the de-
vice to cool down. This may take several minutes. Then switch on the device again, how-
ever the fault will return if the cause of the problem has not been rectified.
WARNING
If the overtemperature alarm sounds, any preparations that are in the device must
be removed and checked before being transferred to the patient.
The Barkey plasmatherm must not be used if it has a fault. The device should be
examined by Barkey GmbH & Co. KG or authorised personnel.