TDK-Lambda NV350FEP Handbuch Seite 13

NV350FEP Handbook
Special Instructions for medical applications (IEC 60601-1:1988 + A1:1991 + A2:1995; EN 60601-1: 1990 +
A1:1993 + A2:1995; UL 60601-1, 1st Edition, 2006-04-26 (includes National Differences for USA) CAN/CSA-
C22.2 No. 601.1-M90 (R2005) (includes National Differences for Canada); IEC 60601-1:2005; EN 60601-1:2006;
ANSI/AAMI ES 60601-1:2005; CSA 22.2 No 60601-1:2008) - Applicable to products with L, R and T Input
Filter Options only
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.
For IEC60601-1, EN60601-1 and UL/CSA 60601-1 (Second Edition standards), the NV350 FEP range provides
basic insulation between input and outputs. The outputs to earth are functional insulation.
For IEC 60601-1:2005; EN 60601-1:2006; ANSI/AAMI ES 60601-1:2005; CSA 22.2 No 60601-1:2008), the NV350
FEP range provides reinforced insulation between input and outputs (2 MOOPs) for all products. The outputs to
earth are functional insulation.
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) serried 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 FEP PSU is connected to the main incoming earth conductor of the end
equipment, the installer must cover the NV350 FEP earth symbol with a label bearing the earth symbol of IEC60417-
5019.
Environmental Specifications:
Description
Use
Temperature
Humidity
Altitude
Pressure
Orientation
Material Group
Pollution Degree
Overvoltage Category
Class
Weight
IP Rating
† - 5000m for 60601-1 Edition 3 only, 3000m for other standards applicable.
Operation
Indoor
0 to 65°C (derating 2.5% per °C above 50°C)
5 to 95% RH, non-condensing
-200m to 5000m†
70kPa to 106kPa.
Horizontal with chassis lowest, on either
side or vertical with the airflow upwards.
-40°C to +70°C (-25°C for IEC inlet)
IIIb
2
II
I
0.9 Kg
IPX0
Page 13 of 22
Storage
-
5% to 95% RH, non-condensing
-200m to 5000m
54kPa to 106kPa.
All
17197 issue 13, June 2014