System Specifications
Electromagnetic Compatibility
User Manual
81
CAUTION: When the system is interconnected with other electrical devices,
leakage currents may be additive, resulting in electromagnetic emissions that
can interfere with the normal function of electronic medical equipment. To
properly control electromagnetic emissions and avoid potential harm to the
patient or user, ensure all electrical devices are installed and interconnected
according to the requirements of IEC 60601-1-1.
CAUTION: Install the system in a room that complies with all applicable IEC, CEC,
and NEC requirements for safety of electrical devices.
CAUTION: Portable and mobile RF communications equipment may affect the
normal function of the system.
CAUTION: Use of the system adjacent to or stacked with other equipment may
result in unexpected electromagnetic circumstances. Prior to such use, test the
operation of the system in the proposed configuration and ensure it meets all
requirements as defined in the tables below. Consult the tables below for
guidance in placing the system.
CAUTION: Use ports on the system exactly as instructed in this manual. Any
other use of these ports may cause unexpected results. See System Overview on
page 23.
CAUTION: Do not use cables or accessories other than those provided by ZELTIQ.
The use of other cables or accessories may result in increased electromagnetic
emissions or decreased immunity to such emissions.
Guidance and Manufacturer
’
s Declaration -- Electromagnetic Emissions
The system is intended for use in the electromagnetic environment specified below. The customer or user of the system
should ensure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic Environment - Guidance
RF Emissions CISPR 11
Group 1
The system uses RF energy only for its internal function; therefore, its RF
emissions are very low and are not likely to cause any interference in
nearby electronic equipment.
RF Emissions CISPR 11
Class A
(A) The system is suitable for use in all establishments other than
domestic, and may be used in domestic establishments and those directly
connected to the public low-voltage power supply network that supplies
buildings used for domestic purposes, provided the following warning
statement is heeded:
CAUTION: The system is intended for use by healthcare professionals only.
The system may cause radio interference or may disrupt the operation of
nearby equipment. It may be necessary to take mitigation measures, such
as reorienting or relocating the system or shielding the location.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
Flicker emissions
IEC 61000-3-3
Class A
