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The safety measures of the Suprasorb
®
CNP P3 therapy unit comply with the regulations of
theGerman Medical Devices Act (MPG) and the generally recognised rules of technology.
Suprasorb
®
CNP P3 is approved in accordance with EU Council Directive 93/42/EEC
onmedical devices and fulfils in particular the essential requirements of Annex I of the
samedirective.
Suprasorb
®
CNP P3 is amedical suction device and has been classified as aClass IIa
medicaldevice in accordance with Annex IX, Rule 11 of EC Directive 93/42/EEC.
Suprasorb
®
CNP P3 satisfies the requirements of the IEC 60601-1-2/EN 60601-1-2
“Electromagnetic Compatibility – Medical electrical equipment” standard.
This minimises electromagnetic interference and interactions.
The quality management system in place at L&R has been certified in accordance with
thepertinent international standards.
Last revised 07-2017
Copyright © 2017
© This document, including excerpts, must not be republished.
The contents as awhole or parts thereof may not be reproduced,
copied or provided to third parties in any shape or form without
the written consent of L&R.
Subject to change without notice. Errors and omissions excepted.