Special Instructions - TDK-Lambda QM5 Mode D'emploi

QM5 AND QS5 HANDBOOK
Special Instructions for medical applications
IEC/EN 60601-1 3rd Edition
ANSI/AAMI ES 60601-1
CSA C22.2 No 60601-1
These products are designed for continuous operation within an overall enclosure, and must be mounted
such that access to the mains terminals is restricted.
These products are NOT suitable for use in the presence of flammable anaesthetic mixtures with air or with
oxygen, or with nitrous oxide.
For IEC 60601-1, EN 60601-1, ANSI/AAMI ES 60601-1, CSA 22.2 No 60601-1 (Third Edition standards) the
QM and QS range provide reinforced insulation between input and outputs (2 MOPPs) and Basic insulation (1
MOPP) between Input and Earth and from Output to Earth.
These products are classed as ordinary equipment and are not protected against the ingress of water (IPX0).
Reference should be made to local regulations concerning the disposal of these products at the end of their
useful life.
Where any part of this product is made accessible to the operator in the end use equipment, the operator
must not touch this part and the patient at the same time.
WARNING: No modification of this product is allowed.

Special instructions:

Whilst all individual outputs are classed as SELV or ES1 outputs in accordance with the standards
IEC/EN/UL/CSA60950-1 or IEC/EN/UL/CSA 62368-1 (<60Vdc or 42.4V peak), seriesed combinations of
these outputs may exceed these values and become Non-SELV or ES2 and ES3 output voltages. Refer to
Output Limitations for further details.
In addition, for IEC/EN/UL/CSA 60601-1 approved products. Series connected outputs with an output voltage
between 60Vdc and up to 160Vdc may increase the working voltages across safety barriers. This may reduce
one level of protection (1 MOPP) between primary and secondary circuits.
For IEC/EN/UL/CSA 60950-1 or IEC/EN/UL/CSA 62368-1 approved products, safety barriers are maintained
with series connected outputs up to 160Vdc.
Page 13 of 37 260362-07, Mar 2020