Wincomm WPC-766, User Manual, Page: 10 / 58

WPC-766/WPC-766E User’s manual x
When networking with electrical devices, the operator is
responsible for ensuring that the resulting system meets the
requirements set forth by the following standards:
– EN 60601-1 (IEC 60601-1)
Medical electrical equipment
Part 1: General requirements for safety
– EN 60601-1-1 (IEC 60601-1-1)
Medical electrical equipment
Part 1-1: General requirements for safety
Collateral standard: Safety requirements for
Medical electrical systems
– EN 60601-1-2 (IEC 60601-1-2)
Medical electrical equipment
Part 1-2: General requirements for safety
Collateral standard: Electromagnetic compatibility;
Requirements and tests
Accessory
equipment
connected
to the
analog and
digital
interfaces
must be in
compliance with the respective nationally harmonized IEC
standards (i.e. IEC 60950 for data processing equipment, IEC
60065 for video equipment, IEC 61010-1 for laboratory
equipment, and IEC 60601-1 for medical equipment.)
Furthermore all configurations shall comply with the system
standard IEC 60601-1-1. Everybody who connects additional
equipment to the signal input part or signal output part
configures a medical system, and is therefore, responsible that
the system complies with the requirements of the system
standard IEC 60601-1-1. The unit is for exclusive interconnection
with IEC 60601-1 certified equipment in the patient environment
and IEC 60XXX certified equipment outside of the patient
environment. If in doubt, consult the technical services
department or your local representative.