________________________________________________________________________________________________________________________________
TensioMed® Arteriograph24™
4
1. Introduction and the intended use of the device
Thank you for choosing TensioMed® Arteriograph24™.
The intended use of the device
The TensioMed® Arteriograph24™ device measures the brachial blood pressure, the
heart rate, and the arterial function parameters intermittently throughout one or more
days.
The measurements are performed non-invasively using a brachial cuff.
The device with its adherent TensioWin software provides the values of brachial blood
pressure, heart rate and several arterial function parameters. It is plausible to use on
those patients, where the information about aortic blood pressure and other arterial
function parameters are desired, but according to the physician’s opinion, the risk of
measuring these parameters by catheter and other invasive methods are higher than the
benefit gained by knowing these parameters.
The Arteriograph24 is a
multiple use device
. The Arteriograph24 device cannot be
connected to any other instrument.
The Arteriograph24 is a professional medical instrument
and cannot be used in a home
environment, i.e., patients cannot use it on their own. The assessment of the measurement
results requires extensive
medical knowledge
.
If the patient has a
pacemaker
, this does not affect the applicability of the Arteriograph24.
If the patient's physiological functions are monitored with
other instruments
(e.g. ECG,
respiratory rate, temperature, oxygen saturation), this does not affect the applicability of
the Arteriograph24.
Do not use the device on patients if high frequency electrosurgical equipment is applied
on them.
If the patient is in a
hyperbaric oxygen chamber
, the Arteriograph24 should not be used.
If the patient has a
skin disease or wound on the upper
arm where the cuff is planned to
be placed, the Arteriograph24 should not be performed.
The device is not recommended to be used in case of atrial fibrillation and other forms of
severe arrhythmia (bigeminy or trigeminy) or in case of severe tremor (e.g. Parkinson
disease). There is no risk to the patient’s health in using the device even in these cases,
but the device will most probably not provide any measurement results. The less severe
forms of arrythmia do no influence the accuracy of the device.
Regarding brachial blood pressure, the limit values and therapeutic recommendations
formulated in the valid national and international methodological guidelines for
hypertension apply.
Unfortunately, the limit values and application recommendations for arterial functions
(PWVao, Aix-ao, SBPao, RT, SAI, DAI, DRA) in methodological guidelines are currently not
yet available, although many studies have been performed to determine the clinical value
of these parameters.
The device is explicitly designed for professional (clinical) use,
not
for public use. In the international medical field,
the standard language is English, and the doctors communicate in English internationally. Thus, we identified the
language requirements, and found English to be the proper international language for the markets of all EU
