6 Product description
ASTOTHERM PLUS Instructions for Use
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6 Product description
6.1 Introduction
ASTOTHERM PLUS is a device for specific heating of blood and fluids which are
delivered to the patients by transfusion, infusion or irrigation. The warming of the
liquid supports the prevention and therapy of hypothermia during or after surgery;
during longer procedures such as dialysis, hemofiltration, or apheresis the warm-
ing leads to a well-being. The applications of the ASTOTHERM PLUS therefore
include transfusion, infusion, dialysis, hemofiltration and apheresis.
The ASTOTHERM PLUS Warmer can be used to warm fluids administered to a
patient at flow rates of 0 to 6000 ml/h (i.e. 0 to 100 ml/min), see
figure 1
.
The infusion extension ASTOTUBE is considered as applied part acc. to IEC/EN
60601-1.
6.2 Technical description
During operation of the Warmer heat is transferred from the internal heating
element to the heat exchanger. Infusion extensions can simply be inserted in the
circumferential groove. The heat from the heat exchanger is transferred through
the inserted infusion extension to the fluid to be warmed.
The temperature of the heat exchanger is monitored by a microprocessor
controlled temperature control system and by two independent alarm systems
designed to alert the operator to failure conditions and, if necessary, to switch off
the heating process automatically in the event of excessively high temperatures.
During operation, the mean temperature of the heat exchanger is displayed; this is
not equal to the temperature of the medium to be warmed. ASTOTHERM PLUS
neither regulates nor monitors/displays the current temperature of the medium to
be warmed. The temperature of the medium (fluid) depends on a variety of factors,
such as, but not limited to additional factors:
Room temperature and ventilation
Inlet temperature of the fluid (warmed-up or cold)
Flow rate