TDK-Lambda CFE400M Mode D'emploi page 13

CFE400M Handbook
Special Instructions for medical applications of the following standards:
nd
IEC/EN 60601-1 2 Edition
UL 60601-1 1st Edition
CAN/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 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.
They are NOT protected against the ingress of water.
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.
For IEC/EN 60601-1 3rd Edition, ANSI/AAMI ES 60601-1, CSA 22.2 No 60601-1, these products provide
reinforced insulation between input and outputs of 2 MOPPs. 1 MOPP from input to earth and 1 MOPP from
output to earth.
These products are suitable for B and BF type medical equipment.
Connect only apparatus complying with the standards listed above as appropriate to the signal ports.
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.
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.
Environmental Specifications:
Description
Use
Temperature
Humidity
Altitude
Pressure
Orientation
Material Group
Pollution Degree
Overvoltage Category
Class
Weight
IP Rating
* - 3000m for 60601-1 Edition 2
Level of Insulation:
Dielectric Strength testing is carried out as follows:
Primary mains circuit to earth: 2.515 to 2.525kVDC
Primary mains circuits to secondary: 5.66kVDC*
Secondary circuits to earth: 2.515 to 2.525kVDC
*Important Note: This test is not possible with Y capacitors fitted to the unit as damage to these
capacitors may occur. It is also necessary to short circuit the outputs together and to earth.
Operation
Indoor
0°C - +70°C (See O/P tables for deratings)
5 - 95% RH, non-condensing
-200m - 5000m*
54kPa - 106kPa
The unit may be mounted on either side, vertical
with input lowest and horizontal. (Customer Air
versions can be mounted in any orientation).
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5 - 95% RH, non-condensing
-200m - 5000m*
54kPa - 106kPa
IIIb
2
II
I
1 Kg max
IPX0
Storage
-
-40°C - +70°C
All
24085 rev 13, April 2020