Lowenstein Medical Allegra M30, Инструкция по эксплуатации, Страница: 50 / 145

1
EN
The safety of the
secretion aspirator Allegra M30
complies with the ac-
knowledged rules of technology and meets the requirements of the
German Medical Devices Act
.
The
secretion aspirator Allegra M30
bears the
CE marking CE0197
in
accordance with the EU Council Directive 93/42/EEC concerning medical devices
and meets the essential requirements of Annex I of this directive.
The
secretion aspirator Allegra M30
has been tested in accordance with IEC
62353.
The
quality management system
applied by
Löwenstein Medical GmbH & Co. KG is certified in compliance with the relevant
international standards.
The
secretion aspirator Allegra M30
is a medical aspirator classified as class
lla in accordance with EU Council Directive 93/42/EEC, Annex IX.
Errors and omissions excepted.