Hartmann Tensoval compact Instrucciones De Uso página 15

13. Legal requirements and
guidelines
Tensoval compact complies with
the requirements of the EC direc-
tive, 93/42/EEC on Medical devices
and bears the CE-marking.
The device complies with the EN
1060 standard relating to non-inva-
sive blood pressure monitors Part 1:
General requirements EN 1060-1:
1995 and Part 3: Additional requi-
rements for electromechanical
blood pressure measuring systems
EN 1060-3: 1997. Clinical testing
of measurement accuracy was
performed according to the testing
protocol recommended by EN
1060-3 (according to DIN 58130
and ANSI/AAMI SP10-1992).
Manufacturer:
PAUL HARTMANN AG
89522 Heidenheim
Germany
16
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14. Accessories and spare parts
To ensure measurement accuracy,
only use original HARTMANN
accessories which may be obtained
from your pharmacist or specialist
med-ical supplier.
Draw-clamp cuff
Code No.: 900 179
Upper arm circumference
22 – 32 cm
Pumping bulb
Code No.: 900 190