Hartmann Tensoval comfort Instrucciones De Uso página 150

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
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 and
ensure that the tube is not
knotted, kinked, or damaged.
If 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 fulfi lled.
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,
152