PaX-Primo
4
Responsibilities of the Manufacturer
When the situation is as below, the manufacturer has the responsibilities for the safe and proper working
of the system.
z When the system is installed as per installation manual.
z When the user uses the system as per user manual and instructions on the program.
z When the user software is installed as per software installation manual.
z When repairs are made by manufacturer’s engineers and/or trained engineers from the
manufacturer.
z When user uses authorized components or approved components.
Standards and Regulations
This product is designed and produced to meet the following standards:
EN 60601-1, EN 60601-1-3, EN 60601-2-7, EN 60601-2-28, EN 60601-2-32,
EN 60601-1-2, EN 61000-3-2, EN 61000-3-3
EN ISO 9001, EN ISO 13485
CE symbol grants the product compliance to the European Directive for
Medical Devices 93/42 as a class IIB device. Authorized by Grand-Duche De
Luxemburg.
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