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Control and operation
HICO-VARIOTHERM 550
43
6.2.9 Obligations during operation
6.2.9.1 Indication-based
Danger caused by overestimation and underestimation of
the performance of the system!
Dangers may arise from the unit if it is put to unintended use
when:
► improper observation of physical connections in external unit
accessories and environmental conditions (pad size, ambient
temperature etc.),
► individual and unpredictable patient reactions.
The reliable therapeutic application of the system requires
the user to carry out a careful risk assessment between the
desired indication and performance of the system, as well as
continuous monitoring and care of the patient, with regards
to side effects, the prophylaxis of pressure induced lesions
by heat or cold.
For low-risk application of hypo/hyperthermia, an external
continuous monitoring of the body core temperature (e.g. by
taking a measurement in the urinary bladder) is of the utmost
importance, since uncontrolled hypo/hyperthermia is associated
with increased patient mortality. See chapter 5.4.2 for indications
/ side effects / contraindications.
The medical information provided here, due to continuously new
knowledge in the field hypo/hyperthermia, does not claim to be
complete. Hirtz & Co. KG has no responsibility or liability for
negligence or false applications and also cannot specify any
medical recommendations and procedures. The user must
independently weigh up what is used and how this is carried out.