Electromagnetic Compatibility - SUBLIMED actiTENS Gebrauchsanleitung

27. ELECTROMAGNETIC COMPATIBILITY

medical device is intended to be used in a home healthcare environment (for example at
actiTENS
home, in the street or at the restaurant) or in a professional healthcare facility environment, while
considering the precautions for use and the conditions described in this chapter.
The kit is designed for use in an electromagnetic environment specified below.
actiTENS
The must ensure that it is used in such an environment.
actiTENS
WARNINGS
ƒ Portable radio frequency communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the
actiTENS, including its cables. Otherwise, degradation of the performance of the
these devices could result. See table 2 for further details on the appliances tested.
ƒ Use of the
actiTENS
could result in improper operation. If such use is necessary, the
should be observed to verify that they are operating normally.
ƒ Use of accessories, transducers and cables other than those specified or provided with the
could result in increased electromagnetic emissions or decreased electromagnetic
actiTENS
immunity of the
actiTENS
Table 1: Manufacturer's directives and declaration – Electromagnetic emissions
EMISSION TEST
CISPR RF emissions
11
CISPR RF emissions
11
Harmonic emissions
IEC 61000-3.-2.
Voltage fluctuations /
flicker IEC 61000-3-3
94
adjacent to or stacked with other equipment should be avoided because it
and result in improper operation.
COMPLIANCE
Group 1
Class B
Class A
Compliant
actiTENS
ELECTROMAGNETIC ENVIRONMENT -
DIRECTIVES
The only uses RF power for its internal
actiTENS
functions. Therefore its RF emissions are very low
and are not likely to cause interference with a nearby
appliance.
The is suitable for use in all places,
actiTENS
including in the home and in places directly
connected to the low voltage mains for domestic
buildings.
actiTENS
and the other equipment
SBM1AL001 – Notice_202202_V10
and