5
Statement
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. Anyone who
connects additional equipment to the signal input part or signal output part is
configuring 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.
