Ener-C CTM Controller 1600 - CTM Exchanger Guide

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Appendix B – Manufacturer‘s declaration
This equipment has been tested and found to comply with the limits for medical devices in
EN 60601-1-2:2015. These limits are designed to provide reasonable protection against harmful
interference in a typical medical installation.
Guidance and Manufacturer’s declaration – Electromagnetic emissions
The CTM Controller® 1600 is suitable for use in the electromagnetic environment specied below.
The customer or the user of the CTM Controller® 1600 should assure that it is used in an environment
as described below.
Table 1 for Emissions
Emission Test
RF emission
CISPR 11
RF Emission
Harmonic Emissions
EN 61000-3-2
Flicker emissions
EN 61000-3-3
Compliance
Group 1
Class B
Class A
Complies
Guidance and Manufacturer’s declaration – Electromagnetic immunity
The CTM Controller® 1600 is suitable for use in the electromagnetic environment specied below. The customer
or the user of the CTM Controller® 1600 should assure that it is used in an environment as described below.
Table 2 for Transient Electromagnetic Immunity
Immunity Test
Electrostatic
Discharge (ESD)
EN 61000-4-2
Radiated RF
EN 61000-4-3
Electrical Fast
transient
EN 61000-4-4
Surge
EN61000-4-5
Conduct
disturbances
EN 61000-4-6
Power frequency
magnetic eld
(50Hz/60Hz)
EN 61000-4-8
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
IEC 60601 Test
Level
± 8 kV contact
± 15 kV air
10 V/m
80 MHz to 3 GHz
± 2 kV for power
supply lines
± 1 kV for input/
output lines
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
10 Vrms
3 A/m
U
T
= 0% 0,5p
0°, 45°, ..., 315°
U
T
= 0% 1p
0°
U
T
= 70% 25/30p
0°
U
T
= 0% 250/300p
Electromagnetic Environment Guidance
DIPS
Interrupt
Compliance –
Level
± 8 kV contact
± 15 kV air
10 V/m
80 MHz to 3 GHz
± 2 kV for power
supply lines
± 1 kV for input/
output lines
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
10 Vrms
30 A/m
U
T
= 0% 0,5p
0°, 45°, ..., 315°
U
T
= 0% 1p
0°
U
T
= 70% 25/30p
0°
U
T
= 0% 250/300p
NOTE: U
T
is the AC mains voltage prior to application of the test level.
Ener-C | CTM Controller® 1600 | Operating manual | Appendix B – Manufacturer's declaration | Rev. 1.1 | 2017-12-12 Ener-C | CTM Controller® 1600 | Operating manual | Appendix B – Manufacturer's declaration | Rev. 1.1 | 2017-12-12