Esaote 350009500, Getting Started, Page: 52 / 114

MyLab
- G E T T I N G S T A R T E D
4 - 12
Safety Concept
MyLab
in its mobile configuration has the option to be equipped with an insulation
transformer to provide required separation from AC mains for both the system
and the auxiliary devices.
Additional equipment connected to
MyLab
must comply with respective IEC or
ISO standards (e.g. IEC 60950 for data processing equipment). Furthermore all
configurations shall comply with the requirements for medical electrical systems
(see IEC 60601-1-1 or clause 16 of the 3rd Edition of IEC 60601-1, respectively).
Anybody connecting additional equipment to medical electrical equipment
configures a medical system and is therefore responsible that the system complies
with the requirements for medical electrical systems. Attention is drawn to the fact
that local laws take priority over the above mentioned requirements. If in doubt,
consult your local representative or the technical service department
Medical environments
Based on IEC60601 three different conditions can be defined for patient
environment:
A) Patient area