P1 Patient Monitor User’s Manual
12-2
Do not measure NIBP on patients with sickle-cell disease or on the limb where
skin damage has occurred or is expected.
Use clinical judgment to determine whether to perform frequent automatic
blood pressure measurements on patients with severe blood clotting disorders
because of the risk of hematoma in the limb fitted with the cuff.
Do not use the NIBP cuff on a limb with an intravenous infusion or arterial
catheter in place. This could cause tissue damage around the catheter when the
infusion is slowed or blocked during cuff inflation.
Do not apply cuff on the arm on the side of a mastectomy.
Continuous cuff pressure due to connection tubing kinking may cause blood
flow interference, and resulting in harmful injury to the patient.
NIBP reading can be affected by the measurement site, the position of the
patient, exercise, or the patient's physiologic condition. If you doubt the NIBP
measurements, determine the patient’s vital signs by alternative means, and
then verify that the monitor is working correctly.
In automatic or continuous measurement mode, if prolonged, cuff friction with
limb may lead to purpura, ischemia, and neuropathy. In patient care, color,
temperature, and sensitivity of distal extremities should be frequently
examined. Check more frequently when making automatic or STAT
measurements. If any abnormalities are observed, the site of the cuff should be
changed or the NIBP measurement should be stopped. Auto NIBP
measurements with one and two minute intervals are not recommended for
extended periods of time.
NIBP diagnostic significance must be decided by the physician.
As the monitor uses an alternative small-bore connector design different from
those specified in the ISO 80369 series, there is a possibility that a
misconnection can occur between the monitor and a medical device using a
different alternative small-bore connector, which can result in a hazardous
situation causing harm to the patient. Special measures need be taken by the
user to mitigate these reasonable foreseeable risks.