Application, Safety Information
8
BPAro
ENG Revision A
1
Application, Safety Information
1.1
Application
Intended Use
The ABPM device is intended to be used in combination
with a suitable blood pressure cuff for the automatic non-
invasive measurement of the blood pressure (single or 24-
h-measurement of the systolic, diastolic and mean value),
the heart rate and other vital or non-vital sign parameters
of human beings in the clinical daily routine.
Indications
If the blood pressure cuffs listed in chapter "Order
Information" fit the patient, it can be used on adults,
children, and small children
In order to measure the blood pressure, a cuff is wrapped
around the upper arm. The blood pressure is measured by
the oscillometric method, during the deflation of the cuff
(deflation method).
The device additionally can measure the blood pressure
measurement during the inflation of the cuff (inflation
method).
The choice between the inflation and the deflation method
is done during the preparation of the device, either directly
on the device or by using the corresponding PC software.
The heart rate is measured from the time distances of the
maximal pressure oscillations occurring in the rhythm of
the heart beat.
The devices support 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.
The intended patient populations for the blood pressure
measurement are adults, children and infants but not
neonates, with a circumference of the upper arm in the
range of 17 to 46 cm. The appropriate approved cuffs have
to fit to the upper arm circumference. The cuffs are
wrapped around the uninjured upper arm, so that they
come in contact only with intact skin.
The devices are not intended to be used in intensive care
medicine or for raising alarm in life-threatening
conditions. The application of the cuff is prohibited on an
arm with a dialysis shunt, fresh operation wounds, or
mastectomy.
If the doctor ascertains a positive benefit-risk ratio, the
application of the cuff is allowed on the arm with a
lymphedema, a paresis or an arterial or venous vascular
access.
A measurement has to be performed at rest.
The devices are available on prescription in health care
medicine and are intended for use following a consultation
and instruction of the patient by a physician (family doctor,
specialist or hospital). They can be used if the
physical condition of the patient allows an
automatic, non-invasive blood pressure measuring under
his observation. Medically trained staff like a doctor or
nurse, etc. should do this judgement as well as the
accommodation of the patients and the preparation and
application of the device. The device can be applied to the
patient during day and night time. The patient does not
operate with the device by himself.
A long-term observation of the blood pressure is limited
by the battery charge or the maximal number of 400
measurement values which can be stored. The devices are
intended to measure and store the blood pressure in
different programmed intervals. The programming is done
by using the corresponding PC-software or by selecting
one of three predefined measuring protocols.
The Oscillometric Measurement Method
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
CardiAI or its representative.
