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

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 cuff.
The device must not be altered,
dismantled or repaired by the
user.
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 relating to non-invasive blood
pressure measuring devices, Part 1:
General requirements and Part 3:
Additional requirements for electro-
mechanical blood pressure meas-
uring 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 mobil device has
been carefully tested by HARTMANN
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 indicated Service address, by
competent authorities or authorised
maintenance providers against
compensation
Instructions for the measure-
ment function check:
A device function check can be
carried out on people or using a
suitable simulator. Measurement
function check involves testing for
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