Intended Use; Warnings And Safety Notes - Beurer BM 35 Mode D'emploi

3. Intended use

Intended use
The blood pressure monitor is intended for the fully automatic,
non-invasive measurement of arterial blood pressure and pulse
values on the upper arm.
Target group
It is designed for self-measurement by adults in the home envi-
ronment and is suitable for users whose upper arm circumfer-
ence is within the range printed on the cuff. The device is also
ideal for taking blood pressure measurements on women who
are pregnant. This was successfully tested as part of a clinical
study (Tempestas, Institut für Medizinische Forschung, Clop-
penburg, Germany).
Indication/clinical benefits
The user can record their blood pressure and pulse values
quickly and easily using the device. The recorded values are
classified according to internationally applicable guidelines and
evaluated graphically. Furthermore, the device can detect any
irregular heart beats that occur during measurement and inform
the user via a symbol in the display. The device saves the re-
corded measurements and can also output average values of
previous measurements. This blood pressure monitor also has
a haemodynamic stability display, which is referred to as a rest-
ing indicator throughout these instructions for use. This shows
whether you, and consequently your circulatory system, are suf-
ficiently at rest when the blood pressure measurement is being
taken, and whether the measured blood pressure thus corre-
sponds to your blood pressure when at rest. Read more about
this under "Resting indicator" in the section on using the device.
The recorded data can provide healthcare service providers
with support during the diagnosis and treatment of blood pres-
sure problems, and therefore plays a part in the long-term moni-
toring of the user's health.

4. Warnings and safety notes

Contraindications
• Do not use the blood pressure monitor on newborns, children
or pets.
• People with restricted physical, sensory or mental skills
should be supervised by a person responsible for their safety
and receive instructions from this person on how to use the
device.
• If you have any of the following conditions, it is essential you
consult your doctor before using the device: cardiac arrhyth-
mia, circulatory problems, diabetes, pregnancy, pre-eclamp-
sia, hypotension, chills, shaking.
• People with pacemakers or other electrical implants should
consult their doctor before using the device.
• The blood pressure monitor must not be used in connection
with a high-frequency surgical unit.
• Do not use the cuff on people who have undergone a mastec-
tomy.
• Do not place the cuff over wounds as this may cause further
injury.
• Make sure that the cuff is not placed on an arm in which the
arteries or veins are undergoing medical treatment, e.g. intra-
vascular access or intravascular therapy, or an arteriovenous
(AV) shunt.
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