COOLTONE User Manual
Appendix B
:
System Specifications
-C
43
Medical Safety Standards
The system complies with the following medical safety standards:
•
IEC60601-1 AMD.1.ED.3.1.B2012
•
IEC 60601-2-10:2016
Electromagnetic Compatibility
With regards to the EMC (electromagnetic compatibility) 4
th
Edition, medical electrical devices such
-
as
the CoolTone are subject to special safety measures and must be installed and commissioned in
accordance with the EMC instructions in the operating instructions or accompanying documents.
Portable and mobile HF communications equipment (e.g mobile telephones, cell phones) can
impact medical electrical devices.
The CoolTone may only be operated using the original power cable indicated in the scope of delivery list.
Operating the device with another power cable can lead to increased emissions or reduced interference
resistance of the device.
The
CoolTone
must not be operated near active HF surgery devices or magnetic resonance tomography
that can cause high levels of electromagnetic interference.
The device was tested for RF immunity only at selected frequencies. Nearby transients at other
frequencies may result in degraded operation. The frequencies tested are listed in Table 4.
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could
result in improper operation. If such use is necessary, this equipment and the other equipment should be
observed to verify that they are operating normally.
Use of accessories, applicators and cables other than those specified or provided by the manufacturer of
this equipment could result in increased electromagnetic emission or decreased electromagnetic
immunity of this equipment and result in improper operation.
Portable RF communication equipment (including peripherals such as antennas) should be used no
closer than 30 cm (approx. 1 foot) to any part of the device
CoolTone
including cables specified by the
manufacturer. Otherwise, degradation of the performance of this equipment could result.
The
CoolTone
is developed according to the recognized standards of technology; the information on the intended
use of the components is taken into account.
The electromagnetic compatibility of the
CoolTone
device has been tested on the original device with the
applicators.
The
CoolTone device
contains no interchangeable components, cables or power cord that lead to deterioration
of the EMC.
The
CoolTone device
does not contain any components which age over the course of the device life time and
could lead to a deterioration of the electromagnetic compatibility. Thus, no maintenance is required during the life
of the device to ensure basic safety. All tests according to standard IEC 60601-1-2 Ed. 4.0 were performed. No
other standards and regulations for electromagnetic compatibility have been applied.
