TDK-Lambda EFE400M Mode D'emploi page 13

EFE400M Instruction Manual
Special Instructions for medical applications
IEC/EN 60601-1 3rd Edition
ANSI/AAMI ES 60601-1
CSA C22.2 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.

For Class II installation, these products need to be fixed such that they are isolated from unearthed accessible
conductive parts by at least 2 MOPP's (Reinforced).

The perforated cover when fitted to the EFE400MxD (Class II) must be treated as a live part with 1 MOPP
(Basic/Supplementary) insulation to primary and 1 MOPP (Basic/Supplementary) insulation to secondary.

These products are NOT suitable for use in the presence of flammable anaesthetic mixtures with air or with
oxygen, or with nitrous oxide.

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 and 1 MOPP from
output to earth at 250Vac and due consideration must be given to this in the end product.

These products are suitable for B and BF type medical equipment.

These products are NOT protected against the ingress of water.

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.

EFE400MxD models (Class II) must be assessed for Accessible Parts in the end equipment.

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.
Special Instructions for 60950-1

EFE400MxD models (Class II) must be assessed for Accessible Parts in the end equipment.

EFE400MxD models (Class II) must be assessed for Limited Current in the end equipment.

For Class II installation, these products need to be fixed such that they are isolated from unearthed accessible
conductive parts by Reinforced insulation.
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
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*
54kPa (5000m)/70kPa (3000m) - 106kPa
The unit may be mounted in any orientation except
inverted (mounted on its top) or vertical with the
airflow downwards.
Page 13 of 27
Storage & Transportation
-40°C - +70°C
5 - 95% RH, non-condensing
-200m - 5000m
54kPa - 106kPa
IIIb
2
II
I or II
1 kg max
IPX0
-
ALL
23198 issue 19, February 2022