Hartmann TENSOVAL comfort Instructions For Use Manual page 53

I f you have had a mastectomy,
�
do not carry out the measure-
ment on the arm on the affected
side of the body.
P lease note that the pressure
�
built up by the cuff can lead to
temporary disruption to medical
devices being simultaneously
used on the same arm.
I f 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.
P lease wait for one minute
�
between two measurements and
ensure that the tube is not
knotted, kinked, or damaged.
I f you are carrying out the mea-
�
surement on another person,
please ensure that the use of the
device does not result in persis-
tent impairment of the blood
circulation.
14. Legal requirements and
guidelines
Tensoval comfort 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 mea-
suring devices, Part 1: General
requirements and Part 3: Additional
requirements for electro-mechanical
blood pressure measuring systems.
Clinical testing of measuring accu-
racy was performed according to
the European Standard EN 1060-4.
The requirements according to the
ANSI/AAMI test protocol SP10-1992
are also fulfilled.
Portable and mobile high-frequency
and communication devices, such
as telephone and mobile phone,
can impair the functional capability
of electronic medical devices. In
compliance with European
Standard EN 60601-1-2 further
information can be supplied by
HARTMANN on request.
Over and beyond the legal
requirements, the device has been
validated by the ESH (European
Society of Hypertension) in accor-
dance with the ESH-IP2 protocol.
15. Instructions for the
calibration check
We recommend a calibration check
at intervals of two years in the case
of professionally used devices, for
example in pharmacies, medical
practices, or hospitals. You should
also observe the national regula-
tions determined by the legislator,
150