Environmental Specifications - TDK-Lambda EFE300M Handbuch

EFE300M Handbook
Standard Specific Safety Instructions:
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.
These products have a Reinforced barrier between input and output in accordance with the standards listed
above . They are NOT protected against the ingress of water.
Connect only apparatus complying with the standards listed above as appropriate to the signal ports.
All outputs have basic spacings to earth rated for mains - 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.
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.
Special instructions for applications covered by IEC/EN/UL/CSA61010-1
If the equipment is used in a manner not specified by the manufacturer, the protection provided by the
equipment may be impaired.

Environmental Specifications:

Description
Use
Temperature
Humidity
Altitude
Pressure
Orientation
Material Group
Pollution Degree
Overvoltage Category
Class
Weight
IP Rating
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.
Safety Approvals:
Operation
Indoor
0°C - +70°C (derating at 2.5%/°C above 50°C) -
Covered by approvals.
5 - 95% RH, non-condensing
-200m to 5000m for UL/CSA/IEC/EN60950-1,
UL/CSA/IEC/EN61010-1
-200M to 3000m for the 60601-1 standards
70kPa - 106kPa
The unit may be mounted in any orientation except
inverted (mounted on its top) or vertical with the
airflow downwards.
Page 13 of 24
5 - 95% RH, non-condensing
-200m - 5000m
54kPa - 106kPa
IIIb
2
II
I
1 Kg max
IPX0
17342 issue 24, October 2018
Storage
-
-40°C - +70°C
ALL