C-4 Starling Monitor - User Guide
NIBP Module
Accuracy of any blood pressure measurement may be affected by the position of the
subject, his or her physical condition and use outside of the operating instructions
detailed in this user guide. Interpretation of blood pressure measurements should be
made only by a physician or trained medical staff.
All air hoses and cuffs used to connect the patient to the module must be either supplied
or approved by Baxter. Hoses of a certain material and/or durometer may cause the
module to perform in an improper fashion. Also, cuffs that are extremely small or large
in volume may cause errors to occur depending on the BP mode selection.
If the blood pressure cuff is on the same limb as monitoring equipment (i.e., pulse
oximeter probe), the pressurization within the cuff can cause temporary loss of function
of the monitoring equipment.
If the blood pressure cuff is on the same limb as a pulse oximeter probe, the oxygen
saturation results will be altered when the cuff occludes the brachial artery.
To obtain accurate blood pressure readings, the cuff must be the correct size, and also
be correctly fitted to the patient. Incorrect size or incorrect fitting may result in
incorrect readings.
When a cuff is used on a patient for an extended length of time, be sure to occasionally
check the limb for proper circulation.
Intra-arm differences vary between people. Do not assume that measurements from
both arms are same.
The module may not operate correctly if used or stored outside the relevant
temperature or humidity ranges described in Table C-2.
Intended patient populations include adult, pediatric and neonate patients. Safety and
effectiveness on pregnant women has not been tested.
For neonate populations, the clinical effectiveness of this device has not been
established in the presence of dysrhythmias. Arterial reference sites included femoral,
umbilical and radial arteries.
Note
For adult and pediatric populations, K5 was used to clinically validate diastolic pressure.