SHOULDER PACEMAKER
TM
- User Manual 04-06EN
11
Guidance and manufacturer's declaration - electromagnetic emissions
Shoulder Pacemaker
TM
is designed to operate in the electromagnetic environment specified below. The customer or user of the device should
ensure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment
CISPR 11 RF emission
Group 1
Shoulder Pacemaker
TM
uses RF energy only for its internal operation. As a result,
RF emissions are very low and are unlikely to cause any interference in nearby
electronic devices
CISPR 11 emission
Class B
Shoulder Pacemaker
TM
is suitable for the use in all environments, including
those directly connected to a public low-voltage grid supply.
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage fluctuations / flicker
emissions IEC 61000-3-3
Not applicable
Table 1:
electromagnetic emissions
Guidance and manufacturer's declaration - electromagnetic immunity
Shoulder Pacemaker
TM
is designed to operate in the electromagnetic environment specified below. The customer or user of the device should
ensure that it is used in such an environment
Proof of Immunity
Test level of IEC 60601
Level of compliance
Electromagnetic field
Electrostatic discharge (ESD)
IEC 61000-4-2
in c- 8kV
In c- 8kV
Floors must be wood, concrete or ceramic tiles.
If the floors are covered with synthetic material,
the relative humidity should be at least 30%.
in air +- 2;4;8;15kV
in air +- 2;4;8;15kV
High frequency magnetic
field (50/60Hz) IEC 61000-4-
8
30 A/m
30 A/m
Power frequency magnetic fields should have
characteristic levels of a typical location in a
commercial or hospital environment.
Table 2:
electromagnetic immunity
Summary of Contents for SHOULDER PACEMAKER SPM Series
Page 1: ......
