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* Patient Warming Systems
M000 Control Unit Operator’s Manual: U .S .
The KIMBERLY-CLARK* Patient Warming System has been designed to monitor and
control patient temperature . The indications for use of the device include any con-
dition where patient temperature control within the range covering mild hypother-
mia to normothermia is required . The system consists of M000 Control Unit, Fluid
Delivery Line, Thermal Pads and other associated accessories . Using a novel direct
heat conduction approach, the Patient Warming System aids in the elimination of
unplanned hypothermia .
Unplanned hypothermia may occur for a variety of reasons, including exposure to
cold environments, brain injury, or complex surgical procedures . During surgery, a
patient typically experiences mild hypothermia due to the effect of general
anaesthesia on the body’s thermoregulatory system and prolonged exposure of
internal organs . Mild hypothermia in the medical or surgical patient has been proven
to prolong the time to extubation, contribute to coagulopathies, increase the chance
of infection, and increase cardiac demand as a result of shivering .
The use of the Patient Warming System is designed to be an effective means of
counteracting this drop in patient temperature by applying heat to the patient
through a set of patented thermally conductive foam pads .
The KIMBERLY-CLARK* Patient Warming System meets the electrical safety require-
ments of IEC 6060 and UL 260, the relevant safety standard for electrical medical
devices . The control unit has also been tested to meet both the electromagnetic
interference and susceptibility requirements of IEC 6060-, and is compatible with
other equipment that also currently conforms to that standard . There is no known
failure mode in the Patient Warming System M000 Control Unit associated
with electromagnetic interference from other devices .
The Patient Warming System M000 Control Unit bears the following symbols affixed
to the system . (see Table )
1
Schwab S. Schwart S. Spranger M, et al. Moderate Hypothermia in the Treatment of
Patients with Severe Middle Cerebral Artery Infarction.
Stroke
1998;29 (12): 2461-6
. Introduction
.2 Symbols and
Standards