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 require-
ments 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 17
14. Accessories and spare parts
To ensure measurement accuracy,
only use original HARTMANN acces-
sories which may be obtained from
your pharmacist or specialist med-
ical supplier.
䡵
Draw-clamp cuff
Code No.: 900 179
Upper arm circumference
22 – 32 cm
䡵
Pumping bulb
Code No.: 900 190
English
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