Sanitas SBC 15, Instructions For Use Manual, Page: 32 / 80

• This device complies with European Stand-
ard EN 60601-1-2 (in accordance with CISPR 11,
EN 61000-4-2, EN 61000-4-3, EN 61000-4-8) and is
subject to particular precautions with regard to electro-
magnetic compatibility. Please note that portable and
mobile HF communication systems may interfere with
this unit.
• The device complies with the EU Medical Devices
Directive 93/42/EEC, the German Medical Devices Act
(Medizinproduktgesetz) and the standards EN 1060-1
(Non-invasive sphygmomanometers – Part 1: General
requirements), EN 1060-3 (Non-invasive sphygmoma-
nometers – Part 3: Supplementary requirements for
electro-mechanical blood pressure measuring sys-
tems) and IEC 80601-2-30 (Medical electrical equip-
ment – Part 2 – 30: Particular requirements for the
basic safety and essential performance of automated
non-invasive sphygmomanometers).
• The accuracy of this blood pressure monitor has been
carefully checked and developed with regard to a long
useful life. If using the device for commercial medical
purposes, it must be regularly tested for accuracy by
appropriate means. Precise instructions for checking
accuracy may be requested from the service address.
Subject t
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or and changes
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