Application, Safety Information - GE TONOPORT VI Operator's Manual

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Application, Safety Information

1.1 Application
Intended use
TONOPORT VI is a small-size, portable blood pressure
monitor for ambulatory, non-invasive measurement of
the patient's blood pressure. If the blood pressure cuffs
listed in chapter "Order Information" fit the patient, it can
be used on adults, children, and small children.
TONOPORT VI is not suitable for blood pressure
measurements in neonates. Also, it is not suitable for use
in intensive-care medicine. TONOPORT VI is intended
for use following consultation and instruction by a
physician.
The device supports the physician in the diagnosis and
supervision of pathophysiological blood pressures like
hypertension or hypotension. To establish a diagnosis the
measurement values should be combined with other
measurements and physical examinations of the patient.
TONOPORT VI can record up to 400 blood pressure
measurements at selectable intervals and save the results.
Note
CASE / CardioSoft v6.73 supports only up to 200
memory readings.
There is a choice of three different measurement
protocols.
Using TONOPORT VI with CASE/CardioSoft
TONOPORT VI can be operated in conjunction
with CASE (version 6.73 or later) or with the
analysis program CardioSoft (version 6.73 or later)
that is included with TONOPORT VI. If the USB
port is used, it is necessary to install the appropriate
driver first (see "Software Installation"). With these
systems, individual measurement protocols can be
created and the stored data can be reviewed on
screen in tabular and graphic form. The patient ID
used by the analysis program can be stored in
TONOPORT VI to allow the collected data to be
downloaded without selecting the patient first (refer
to the respective Operator Manuals).
2001589-312 Revision B
Application, Safety Information
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 GE
Healthcare or its representative.
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
determined either during deflation of the cuff (deflation
measurement 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 common
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.
Fig. 1-1 Waveform representing the pressure in the cuff
TONOPORT VI
Biocompatibility
during a measurement using the deflation
measurement method: systolic pressure at
125 mmHg, diastolic pressure at 83 mmHg
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