TDK-Lambda Vega 900 Instrucciones De Uso página 13

Vega 900 Handbook
Special Instructions for medical applications
IEC/EN 60601-1 2nd Edition
UL 60601-1 1st Edition
CSA-C22.2 No. 601.1-M90
IEC/EN 60601-1 3rd Edition
ANSI/AAMI ES 60601-1
CSA C22.2 No 60601-1
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These products are designed for continuous operation within an overall enclosure, and must be mounted such
that access to the mains terminals is restricted.
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These products are NOT suitable for use in the presence of flammable anaesthetic mixtures with air or with
oxygen, or with nitrous oxide.
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The Vega 900 range provides Reinforced insulation between input and outputs, and functional insulation between
outputs and earth.
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For SELV and ES ratings see "ES ratings (IEC/EN/UL/CSA 62368-1) and Outputs Connected In Series" and
"SELV ratings and Outputs Connected In Series" section below.
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These products are classed as ordinary equipment and are not protected against the ingress of water (IPX0).
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Reference should be made to local regulations concerning the disposal of these products at the end of their
useful life.
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For IEC/EN 60601-1 2nd Edition, UL 60601-1 1st Edition, CSA-C22.2 No. 601.1-M90, these products have a
reinforced insulation barrier between input and output and Basic insulation barrier between input and Earth.
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For IEC/EN 60601-1 3rd Edition, ANSI/AAMI ES 60601-1, CSA C22.2 No 60601-1, these products provide
reinforced insulation between input and outputs of 2 MOPPs. 1 MOPP from input to earth (except the IEC inlet
and cooling options D and E which are 1 MOOP) and due consideration must be given to this in the end product.
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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.
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These products have not been assessed to IEC/EN60601-1-2 (EMC) but EMC test data is available from TDK-
Lambda UK Ltd.
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WARNING: No modification of this product is allowed.
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Except for permanently installed equipment, the overall equipment into which these products are installed must
have double pole fusing on the input mains supply. The products themselves have single pole fusing in the live
line only.
Special Instructions for IEC/EN/UL/CSA 61010-1
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Whilst all individual module single outputs are classed as SELV outputs in accordance with IEC/EN/60950
(<60Vdc or 42.4V peak) series combinations of these modules may exceed these values and become hazardous
output voltages. For IEC/EN61010-1 the equivalent limits are 70Vdc, 33Vrms or 46.7V peak. Provided these
levels are not exceeded, the outputs are not considered hazardous for IEC/EN61010-1.
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If the equipment is used in a manner not specified by the manufacturer, the protection provided by the equipment
may be impaired.
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If the earth terminal of the Vega PSU is connected to the main incoming earth conductor of the end equipment,
the installer must cover the Vega earth symbol with a label bearing the earth symbol of IEC60417-5019.
Page 13 of 34 17155 issue 26, Sept 2019