Safety Information; Legal Requirements And Guidelines - Hartmann Tensoval mobil Mode D'emploi

13.2 Safety information

The device is not waterproof!
Do not leave the device
unattended near toddlers or
persons who cannot operate it
themselves.
Use the device for taking blood
pressure measurements on the
wrist only.
Do not under any circumstances
carry out blood pressure mea-
surements on babies or toddlers.
Do not expose the device to
hard knocks or vibrations.
Do not drop the device to the
fl oor.
The device must not be altered,
dismantled, or repaired by the
user.
Do not excessively bend or fold
the cuff.
Never infl ate the cuff when it is
not properly applied to the wrist.
Please do not apply the cuff over
a wound, as this may result in
further injuries.
If you have had a mastectomy,
do not carry out the measure-
ment on the arm on the affected
side of the body.
Please note that the pressure
built up by the cuff can lead to
4 TM IV_GA_GB.indd 118 4 TM IV_GA_GB.indd 118
temporary disruption to medical
devices being simultaneously
used on the same arm.
If an intravenous treatment is
being carried out or a venous
catheter is present on the arm,
blood pressure measurements
can lead to injury. Never use the
cuff on the arm on which these
conditions apply.
Please wait for one minute
between two measurements.
If you are carrying out the
measurement on another
person, please ensure that the
use of the device does not result
in persistent impairment of the
blood circulation.
14. Legal requirements and
guidelines
Tensoval mobil complies with the
requirements of the EC directive
93/42/EEC on medical devices
(Medical Device Directive MDD) and
bears the CE mark.
The device complies, for example,
with the European Standard EN
1060: Non-invasive blood pressure
measuring devices, Part 1: General
requirements and Part 3: Additional
requirements for electro-mechanical
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