TDK-Lambda NV350 Manual De Instrucciones página 13

NV350 Handbook
Special Instructions for medical applications of the following standards:
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IEC/EN 60601-1 2 Edition +A1 + A2
UL 60601-1, 1st Edition
CAN/CSA-C22.2 No. 601.1-M90
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IEC/EN 60601-1 3 Edition + A1
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.
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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For IEC/EN60601-1 2 Edition + A1 + A2, UL60601 1 Edition, CAN/CSA-C22.2 No. 601-M90, the NV350 range
provides the following levels of insulation: For PSU's fitted with C and/or CM Modules only there is Reinforced
insulation between input and outputs. For all other PSU's there is a basic insulation between input and outputs. For
PSU's fitted wiith CM Modules only, there is basic insulation at the working voltage between the CM module outputs
and earth (provided that a CM module is not fitted in slot 1).
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For IEC/EN 60601-1 3 Edition + A1, ANSI/AAMI ES 60601-1, CSA 22.2 No. 60601-1, the NV350 range provides
reinforced insulation between input and outputs (2 MOOPs) for all products. For PSU's fitted wiith CM Modules only,
there is basic insulation at the working voltage between the CM module outputs and earth (1 MOPP) (provided that a
CM module is not fitted in slot 1). For PSU's fitted with C and CM modules there are two MOPPs from input to output
at 4000 meters only.
Connect only apparatus complying with the standards listed above as appropriate to the signal ports.
All outputs are SELV except possibly when they are connected in series and depending on the total voltage.
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.
These products have not been assessed to IEC/EN60601-1-2 (EMC) but EMC test data is available from TDK-
Lambda UK Ltd.
WARNING: No modification of this product is allowed.
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
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.
If the equipment is used in a manner not specified by the manufacturer, the protection provided by the equipment
may be impaired.
If the earth terminal of the NV350 PSU is connected to the main incoming earth conductor of the end equipment, the
installer must cover the NV350 earth symbol with a label bearing the earth symbol of IEC60417-5019.
Special instructions for IEC/EN/UL/CSA 62368-1
Outputs that may have been previously SELV (in accordance with 60950, 61010) need to be reconsidered as Energy
Sources 1, 2 and 3 under 62368-1. Please refer to the Energy Source Classification Table of this document and the
safety file for further guidance.
Page 13 of 30 17158 issue 32, February 2020