TDK-Lambda CUS100ME Manual De Instrucciones página 13

CUS100ME Handbook
Special Instructions for medical applications of the following standards:
nd
IEC/EN 60601-1 2 Edition
UL 60601-1 1st Edition
CSA-C22.2 No. 601.1-M90
rd
IEC/EN 60601-1 3 Edition
ANSI/AAMI ES 60601-1
CSA 22.2 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. See the appropriate standard listed
above.
For Class II installation, these products need to be fixed such that they are isolated from unearthed
accessible conductive parts by at least 2 MOPP's.
The chassis/cover/customer fixing points when fitted to the CUS100ME in a Class II configuration
has 1 MOPP (Basic/Supplementary) insulation to Primary and 1 MOPP (Basic/Supplementary)
insulation to Secondary.
These products are NOT suitable for use in the presence of flammable anesthetic mixtures with air or
with oxygen, or with nitrous oxide.
For IEC/EN 60601-1 2
have a reinforced insulation barrier between input and output, with Basic insulation between Input and
Earth/chassis/customer fixing points and between Output and Earth/chassis/customer fixing points.
For IEC/EN 60601-1 3
provide reinforced insulation between input and outputs of 2 MOPPs. 1 MOPP from input to
Earth/chassis/customer fixing points and 1 MOPP from output to Earth/chassis/customer fixing points.
These products are suitable for B and BF type medical equipment.
These products are NOT protected against the ingress of water.
All outputs have basic spacing to earth rated for mains at 250Vac, and due consideration must be
given to this in the end product design.
These products have SELV outputs.
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.
Special Instructions for IEC/EN/UL/CSA 60950-1
The Baseplate/chassis/customer fixing points when fitted to the CUS100ME in a Class II
configuration has (Basic/Supplementary) insulation to Primary and (Basic/Supplementary) insulation
to Secondary.
Special Instructions for IEC/EN/UL/CSA 62368-1
For Single fuse (/E option) the end equipment manufacturer must use a polarised input connector.
nd
Edition, UL 60601-1 1st Edition, CSA-C22.2 No. 601.1-M90, these products
rd
Edition, ANSI/AAMI ES 60601-1, CSA 22.2 No 60601-1, these products
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