Hartmann Tensoval comfort Instrucciones De Uso página 10

14. Legal requirements and guidelines
Tensoval comfort complies with the
requirements of the EC directive,
93/42/EEC on Medical devices and bears
the CE-marking.
The device complies with the EN 1060
standard relating to non-invasive blood
pressure monitors Part 1/1995: General
requirements and Part 3/1997: Additional
requirements for electromechanical blood
pressure measuring systems. Clinical
testing of measurement accuracy was
performed in Germany according to the
testing protocol recommended by EN
1060-3 (DIN 58130: Central Hospital
Reinkenheide, Prof. Anlauf, Germany, and
according to ANSI/AAMI SP10-1992).
Manufacturer:
PAUL HARTMANN AG, 89522 Heidenheim
Germany
15. Accessories and spare parts
To ensure measurement accuracy, only
use original HARTMANN accessories
which may be obtained from your pharma-
cist or specialist medical supplier.
HARTMANN mains adapter
Code No.: 900 153
"Moulded cuff", normal
Code No.: 900 166
Upper arm circumference 22 – 32 cm
"Draw-clamp cuff" normal
Code No.: 900 154
Upper arm circumference 22 – 32 cm
"Draw-clamp cuff" large
Code No.: 900 155
Upper arm circumference 32 – 42 cm
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