Application, Safety Information
8
PHYSIO-PORT / PHYSIO-PORT AS
A8136 Revision A
1
Application, Safety Information
1.1 Application
Intended Use
PHYSIO-PORT are small size, portable (long-term)
blood pressure monitors for non-invasive measurement of
the patient’s blood pressure. The blood pressure is
measured using the oscillometric method, optionally in
the inflation or deflation phase using a blood pressure
cuff on the upper arm.
The variant PHYSIO-PORT AS can additionally perform
a pulse wave analysis. During an additional holding phase
after the blood pressure measurement the central blood
pressure and the pulse wave velocity can be determined
in a non-invasive way.
If the approved blood pressure cuffs fit the patient, the
PHYSIO-PORT can be used on adults, children and
infants, to support the physician during his diagnosis of
pathological blood pressure. The variant AS is intended
for patients from 12 years of age, to support the physician
during his diagnosis of pathological vascular alteration.
Measurements should be conducted at rest and
not
during
excessive physical activity. The devices are
not
suitable
for blood pressure measurements in neonates and patients
with arrhythmias or acute peripheral occlusion. Also, they
are
not
suitable for use in intensive-care medicine. The
devices are intended for use following consultation and
instruction by professional
medical personnel like
physicians, nurses or medical assistant.
The Oscillometric Measurement Method
The blood pressure is measured by the oscillometric
method. The criteria for this method are the pressure
pulsations superimposed with every systole on the air
pressure in the cuff.
In order to measure the blood pressure, a blood pressure
cuff wrapped around the upper arm needs to be inflated
and subsequently deflated. The blood pressure is deter-
mined either during deflation of the cuff (deflation mea-
surement method) or, by using a novel and faster
technology, already during inflation of the cuff (inflation
measurement method).
The deflation measurement method is the most com-mon
method used. With this technique, the cuff is inflated to a
pressure which must be clearly above the expected
systolic value. Including cuff inflation, the measurement
typically takes approx. 40 seconds. (see Fig. 1-1).
Fig. 1-1 Waveform representing the pressure in the cuff
during a measurement using the deflation mea-
surement method: systolic pressure at 125 mmHg,
diastolic pressure at 83 mmHg
Biocompatibility
The parts of the equipment described in this
manual, including all accessories that come in
contact with the patient during the intended
use, fulfill the biocompatibility requirements
of the applicable standards if used as intended.
If you have questions in this matter, please
contact PAR Medizintechnik or its re-
presentative.
Note
For the visualization of the long-term measure-
ment results, the software PhysioPortWin as of
version 1.5 can be used.
