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

13.2 Safety information

Do not leave the device unat-
tended near toddlers or persons
who cannot operate it them-
selves.
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.
Use the device only with the
approved upper arm cuff;
otherwise the device can be
damaged externally or internally.
The cuff tube may only be
removed from the device by
pulling the red connector. Never
pull on the tube itself.
Never inflate the cuff when it is
not properly applied to the
upper arm
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:
Non-invasive blood pressure meas-
uring devices, Part 1: General
requirements and Part 3:
Supplementary requirements for
electro-mechanical blood pressure
measuring systems.
Clinical testing of measurement
accuracy was performed according
to the European Standard EN 1060-
4 as well as the ISO Standard
81060-2.
Portable and mobile high-frequency
and communication devices 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.
15. Calibration check and
service addresses
15.1 Explanation of calibration
check
Each Tensoval duo control device
has been carefully tested by
HARTMANN for measuring accur-
acy, and been developed for a long
useable service life. We recommend
a calibration check at intervals of
two years in the case of profession-
ally used devices, for example in
pharmacies, medical practices or
hospitals. You should also observe
the national regulations determined
170