2:2001 you may contact our customer support (see section 13, Contact) for further
documentation.
10.1
DIN EN 550112
Industrial, scientific and medical high frequency devices (ISM devices) Radio frequency interference
– limit values and measuring procedure
Interference emission
Interference voltage
RFI field strength (not accredited testing)
10.2
DIN EN 60601 1-1-2
Medical electrical equipment
Part 1-2: General requirements for safety:
Collateral standard: electromagnetic compliance; requirements and testing
10.3
DIN EN 60601 1-2-47
Medical electrical equipment
Part 2-47: Specific requirements for safety including essential performance characteristics for
outpatient electrocardiographic systems
Interference immunity against
Static electrical discharge
High frequency electromagnetic fields (80 – 2500 mHz)
Fast transient disturbances (chest)
Surge voltages
Conducted disturbances, induced by high frequency
Energy-related frequency – Magnetic field 50 Hz (Helmholtz coil)
Voltage dips, short-term interruptions
Test levels as % of UT duration in supply frequency cycles
All testing at 100 V and 240 V each 50 Hz
11 Disposal
Warning:
Ensure proper disposal of CardioSecur (electronic waste).
Labelling on CardioSecur, its packaging, and this user manual indicate that CardioSecur must not
be disposed together with ordinary household refuse after its lifetime. Dispose of CardioSecur
separately, so that harm to the environment or human health is not caused by uncontrolled
disposal.
V12.0
Limit value class
--
B
Testing accuracy
normative
tested
air
8 kV
8 kV
contact
6 (8) kV
8 kV
housing
3 V/m
10 V/m
mains
2 kV
2 kV
I/O
1 kV
unsym.
2 kV
sym.
1 kV
1 kV
mains
3 V
10 V
I/O
3 V
housing
3 A/m
3 A/m
mains UT
<5 %
<5 %
100 – 240V
0,5 Per.
0,5 Per
50 / 60 Hz
40 %
40 %
100 Per.
100 Per.
70 %
70 %
500 Per.
500 Per.
<5 %
<5 %
5000 Per.
5000 Per.
Result
n/a
OK
Result
OK
OK
OK
n/a
-
n/a
-
n/a
n/a
n/a
-
n/a
n/a
n/a
n/a
n/a
n/a
19