35 en – Compex SP8.0 User Manual

Page 37

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35

EN

RF DATA
Transmission frequency band: 2.4[GHz] ISM

The characteristics of the type and frequency of modulation: GFSK, +/-320[kHz] deviation

Effective emission power: 4.4 [dBm]

STANDARDS
To ensure your safety, the stimulator has been designed, manufactured and distributed in accordance with
the requirements of the amended European Directive 93/42/CEE covering medical devices.

The stimulator also complies with the CEI 60601-1 standard covering general safety requirements for
electromedical devices, with the CEI 60601-1-2 standard covering electromagnetic compatibility and the CEI
60601-2-10 standard covering special safety requirements for nerve and muscle stimulators

In accordance with current international standards, a warning must be given about applying electrodes to the
thorax (increased risk of cardiac fibrillation).

The stimulator also complies with Directive 2002/96/CEE covering electrical equipment and electronic waste
(WEEE).

INFORMATION ABOUT ELECTROMAGNETIC COMPATIBILITY (EMC)
The Compex is designed to be used in typical domestic approved environments in accordance with the
safety standard EMC EN 60601-1-2.

This device emits very low levels in the radiofrequency interval (RF) and is therefore not likely to cause
interference with electronic equipment nearby (radios, computers, telephones, etc.).

The Compex is designed to support anticipated disturbance originating from electrostatic discharge,
magnetic fields for the power supply or radiofrequency emitters.

However, it is not possible to guarantee that the stimulator will not be affected by powerful RF fields
(radiofrequency) originating from other sources.

For more information about electromagnetic emission and immunity, please contact Compex.

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