AtriCure cryoICE BOX ACM1, User Manual, Page: 26 / 62

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9 . ELECTROMAGNETIC COMPATABILITY TABLES
Electromagnetic Emissions
Guidance and manufacturer’s declaration – Electromagnetic Emissions
The AtriCure cryo ICE BOX is intended for use in the electromagnetic environment specified below. The
customer or the user of the AtriCure cryo ICE BOX unit should assure that it is used in such an environment.
Phenomenon Professional healthcare facility environment
a)
Conducted and radiated RF EMISSIONS CISPR 11 (Group 1, Class A)
Harmonic distortion See IEC 61000-3-2
b)
(Class A)
Voltage fluctuations and flicker IEC 61000-3-3
b)
a) Professional healthcare facility environment.
b) This test is not applicable in this environment unless the AtriCure cryo ICE BOX used there will be con -
nected to the PUBLIC MAINS NETWORK and the power input Is otherwise within the scope of the Basic
EMC standard.
Electromagnetic Immunity – Enclosure Port
Guidance and manufacturer’s declaration – Enclosure Port Immunity
The AtriCure cryo ICE BOX is intended for use in the electromagnetic environment specified below. The cus -
tomer or the user of the AtriCure cryo ICE BOX unit should assure that it is used in such an environment.
Phenomenon Basic EMC standard or test method
Immunity Test Levels
Professional healthcare facility environ-
ment
ELECTROSTATIC DIS -
CHARGE
IEC 61000-4-2
± 8 kV contact
± 2kV, ± 4kV, ± 8kV, ± 15 kV air
Radiated RF EM fields
a)
IEC 61000-4-3
3 V/m
f)
80 MHz – 2.7 GHz
b)
80% AM at 1kHz
c)
Proximity fields from RF
wireless communications
equipment
IEC 61000-4-3
Refer to Table 9 in IEC 60601-1-2:2014 – Test
specification for Enclosure Port Immunity to
RF wireless communication equipment
Rated power frequency
magnetic fields
d) e)
IEC 61000-4-8
30 A/m
g)
50 Hz or 60 Hz
a) The interface between the PATIENT physiological signal simulation, if used, and the AtriCure cryo ICE BOX shall be located within 0.1 m of the
vertical plane or the uniform field area in one orientation of the AtriCure cryo ICE BOX .
b) ME EQUIPMENT and ME SYSTEMS that intentionally receive RF electromagnetic energy for its operation shall be tested at the frequency of re -
ception. Testing may be performed at other modulation frequencies identified by the RISK MANAGEMENT PROCESS. This test assesses the BASIC
SAFETY and ESSENTIAL PERFORMANCE of an intentional receiver when an ambient signal is in the passband. It is understood that the receiver
might not achieve normal reception during the test.
c) Testing may be performed at other modulation frequencies identified by the RISK MANAGEMENT PROCESS.
d) Applies only to ME EQUIPMENT and ME SYSTEMS with magnetically sensitive components or circuitry.
e) During the test, the AtriCure cryo ICE BOX may be powered at any NOMINAL input voltage, but with the same frequency as the test signal.
f) Before modulation is applied.
g) This test level assumes a minimum distance between the
AtriCure cryo ICE BOX and sources of power frequency magnetic field of at least 15
cm. If the RISK ANALYSIS shows that the AtriCure cryo ICE BOX will be used closer than 15 cm to sources of power frequency magnetic field, the
IMMUNITY TEST LEVEL shall be adjusted as appropriate for the minimum expected distance.