Environmental Specifications - TDK-Lambda Alpha 1000 Mode D'emploi

Alpha 1000 Handbook
Special Instructions for medical applications of the following standards:
nd
IEC/EN 60601-1 2 Edition +A1 + A2
UL 60601-1, 1st Edition
CAN/CSA-C22.2 No. 601.1-M90
rd
IEC/EN 60601-1 3 Edition + A1
ANSI/AAMI ES 60601-1
CSA 22.2 No 60601-1
Applicable to products with LL, RL and TL 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.
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 Alpha 1000 range provides
Basic insulation between input and outputs, Basic insulation between input and ground and functional insulation
between outputs and earth.
For IEC 60601-1:2005; EN 60601-1:2006; ANSI/AAMI ES 60601-1:2005; CSA 22.2 No 60601-1:2008), the Alpha
1000 range provides reinforced insulation between input and outputs (2 MOOPs) and Basic insulation (1 MOOP)
between input and ground for all products. Between outputs and earth there is functional insulation only.
Connect only apparatus complying with the standards listed above as appropriate to the signal ports.
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.

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 - 2.25 - 2.35kVDC
Primary mains circuits to transformer core - 4.25 - 4.35kVDC*
Primary mains circuits to secondary -4.25 - 4.35kVDC.*
Outputs to each other and to earth are isolated to 500VDC.
*This test is not possible with Y capacitors fitted to the unit as damage to these capacitors may occur)
Operation
Indoor
0 to 50°C (derating 2.5%°C above 50°C to 65°C -
Not covered by approvals).
5 to 95% RH non-condensing
-200m to 3000m
70kPa to 106kPa
Horizontal with chassis lowest, on either side or
vertical with the airflow upwards.
Page 13 of 30
IIIb
2
II
I
3 kg (Dependent on configuration)
IPX0
Storage
-
-40°C to +70°C
5% to 95% RH non-
condensing
-200m to 5000m.
54kPa to 106kPa
All
17027 issue 29, September 2018