System Specifications
CoolSculpting® Elite
System User Manual
68
CS-UM-CM3-02-EN-D
Medical Safety Standards
The system complies with the following medical safety standards:
•
IEC 60601-1:2005/A1:2012
Electromagnetic Compatibility
The system has been tested and found to comply with Medical Standard Electromagnetic Compatibility
(EMC) IEC 60601-1-2:2014. The system complies with the standards outlined below.
This system requires special precautions to ensure electromagnetic compatibility with other electrical
medical devices. To ensure EMC, the system must be installed and operated according to the
information provided in this manual.
When the system is interconnected with other electrical devices, it may result 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.
Install the system in a room that complies with all applicable IEC, CEC, and NEC requirements
for safety of electrical devices.
Portable and mobile RF communications equipment may affect the normal function of the
system.
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.
Use ports on the system exactly as instructed in this manual. Any other use of these ports may
cause unexpected results. See “System Overview”.
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.
The system is intended for use in the electromagnetic environment specified in Table 27: Guidance and
Manufacturer’s Declaration - Electromagnetic Emissions. The customer or user of the system should
ensure that it is used in such an environment.
