CyberMed H22/N22 User’s manual
xi
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.
