LINET AVE 2 - Overview of Basic Versions; Overview of Colour Verisons; Safety

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4.1 Overview of basic versions
PPB-AX
basic type
4.2 Overview of colour verisons
Substituted by the letter “X”.
A – Purple
M – Corn Yellow
B – Brilliant Blue
P - Orange
F – Ocean Green
T - Pink
4.3 Safety
Standards
The product meets the requirements of valid standards EN 60 601-1 ed. 3 and IEC 60 601-1-2 ed. 2.
According to the current text of the Directive on Medical Instrumentation 93/42/EEC, the birthing bed
is classified as medical device of 1
st
class, non-sterile, without measuring function.
The bed complies with the following standards and directives:
 ANSI/AAMI ES60601-1
 ANSI/AAMI/IEC 60601-1-2
 IEC 60601-1-6
 IEC 60601-2-52
 ANSI/AAMI/ISO 14971
 AAMI/ANSI/ISO 10993
 16 CFR 1632
The manufacturer complies with the following standards:
 21 CFR 820
 ISO 9001
 ISO 14001
 ISO 13485
Function
Warning:
Caution
The essential functions are lying, sitting and supporting the woman in labour. Additionally, it is the CPR
position.