Safety Information; Legal Requirements And Guidelines; Measurement Function Check And Service Addresses; Explanation Of Measurement Function Check - Hartmann Tensoval duo control Instructions For Use Manual

13.2 Safety information

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
upper arm only.
Do not expose the device to
hard knocks or vibrations.
Do not drop the device to the
floor. Do not excessively bend or
fold the arm cuff and the air
tube.
The device must not be altered,
dismantled or repaired by the
user.
14. Legal requirements and
guidelines
Tensoval duo control 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 relating to non-invasive blood
pressure measuring devices, Part 1:
General requirements and Part 3:
Additional requirements for electro-
mechanical blood pressure measur-
ing systems. Clinical testing of meas-
urement precision was performed
according to the European
Standard EN 1060-4.
Manufacturer: PAUL HARTMANN
AG, D-89522 Heidenheim, Germany
15. Measurement function check
and service addresses
15.1 Explanation of measure-
ment function check
Each Tensoval duo control device
has been carefully tested by HART-
MANN for measuring precision, and
been developed for a long useable
service life.
We recommend a check of the
measurement function at intervals
of two years in the case of profes-
sional users, such as pharmacies,
medical practices or hospitals. You
should also observe the national
regulations, such as, in Germany,
the "Medizinprodukte-Betreiberver-
ordnung" (Medical Device
Operating Regulation).
Measurement function checks can
be carried out either by the indica-
ted Service address, by competent
authorities or authorised maintenan-
ce providers against compensation.
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