Maico MA 27 Operation Manual page 11

Operation Manual MA 27 / MA 27e
This equipment is intended to be connected to other equipment
thus forming a Medical Electrical System. External equipment
intended for connection to signal input, signal output or other
connectors shall comply with the relevant product standard e.g.
IEC 60950-1 for IT equipment and the IEC 60601-series for
medical electrical equipment. In addition, all such combinations
– Medical Electrical Systems – shall comply with the safety
requirements stated the general standard IEC 60601-1, edition
3, clause 16. Any equipment not complying with the leakage
current requirements in IEC 60601-1 shall be kept outside the
patient environment i.e. at least 1.5 m from the patient support
or shall be supplied via a separation transformer to reduce the
leakage currents. Any person who connects external equipment
to signal input, signal output or other connectors has formed a
Medical Electrical System and is therefore responsible for the
system to comply with the requirements. If in doubt, contact
qualified medical technician or your local representative. If the
instrument is connect to a PC (IT equipment forming a system)
ensure not to touch the patient while operating the PC.
If the instrument is connect to a PC (IT equipment forming a
system) assembly and modifications shall be evaluated by
qualified medical technician according to safety regulations in
IEC 60601.
8104818 Rev.2.0 7 04/16