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 measu-
ring systems. Clinical testing of
measurement precision was perfor-
med 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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Instructions for the measure-
ment function check:
A device function check can be car-
ried out on people or using a suita-
ble simulator. Measurement func-
tion check involves testing for leak
tightness of the pressure system
and possible deviations of the pres-
sure reading.
Remove at least one battery in
order to switch to calibration mode.
Hold down on the START/STOP but-
ton and then insert the battery.
Release the button and, after a few
moments, two zeros will appear
one above each other on the dis-
play.
Instructions on the measurement
function check will be supplied on
request to competent authorities or
authorised maintenance providers
by HARTMANN.
15.2 Contact information for
customer queries
ESCoor Electronic Service
Coordination GmbH
D-21337 Lüneburg, Germany
PAUL HARTMANN AG, Heidenheim
0800-400 400 9
(toll free within Germany)
English
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