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Burn Navigator® User’s Manual
Page 4
in a particular patient, such as can happen with acute renal failure or use of
diuretics, consult with attending physician for appropriate fluid therapy.
WARNING! The Weight-based protocol is not intended for patients weighing less
than 10 kg, because immature kidneys may not regulate output during
hypovolemia.
WARNING! Patients with inhalation injuries may need a higher rate of fluid
resuscitation than the Burn Navigator algorithm recommends. Consult physician
regarding appropriate fluid rates for a patient with an inhalation injury.
WARNING! Giving fluids in addition to the primary resuscitation fluid may require
an adjustment to the fluid infusion rate by the user, different from the rate
recommended by Burn Navigator.
The attending physician should be contacted to
determine the appropriate fluid infusion rate.
MR Unsafe.
The Burn Navigator should
not
be used during a magnetic resonance
imaging (MRI) procedure. Do
not
use the Burn Navigator in the same room or an
adjacent room to the room where an MRI procedure is being performed. Consult
the MRI device manual to determine the appropriate safe distance of use.
Essential Performance:
The Burn Navigator provides fluid therapy
recommendations for serious burn patients. If the Burn Navigator fails to
generate a recommendation, clinicians will use an alternative guide to fluid
resuscitation (e.g. Parkland or Modified Brooke formulas). The generation of a
recommendation is not considered essential performance for patient safety. The
other Burn Navigator features provide additional views to aid clinical judgment
and also are not considered essential performance for patient safety.
The Burn Navigator needs special precautions regarding electromagnetic
compatibility (EMC) and needs to be installed and put into service according to
the EMC information provided in this manual.
The Burn Navigator should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, observe the device to verify
normal operation in the configuration in which it will be used.
Portable and mobile radio-frequency (RF) communications equipment can affect
medical electrical equipment.