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Dynamic electrical- and dynamic magnetic interference fi elds may interact with the device and the system.
These interactions may have an infl uence on the measurement of the actual stimulus current, and in the
extreme case, they may lead to an error in indication and perhaps to a safety-shutdown of the device.
The MultiStim SWITCH may not be used near equipment emitting strong magnetic fi elds, e.g. radio-
telephones, surgical RF-devices, short wave- or microwave-therapy devices. Any potential introduction
of high-frequency currents into the stimulation cannula may lead to a damaging of the nerves.
The device may not be connected with other equipment. If the MultiStim SWITCH is operated nearby
to another device, then the devices or the system must be monitored and the correct functioning as
intended must be verifi ed in this arrangement as it is being used.
Under unfavorable conditions, the MultiStim SWITCH may disturb other equipment in its function. We
therefore recommend to check all other equipment and facilities for compatibility with the MultiStim
SWITCH, and if necessary, to remove these from the patient.
The operation of other equipment or systems with the accessories may lead to increased emissions or
to reduced interference immunity of these systems. Please observe the enclosed EMC (electromagnetic
compatibility) information regarding installation, start-up and operation of the equipment or system
(see chapter Electromagnetic Compatibility (EMC)).
To avoid damaging the connector cable and the device, please do not hold or carry the device by its con-
nector cables or by its accessories. Do not wind the cable around the device or around other facilities.
The winding of the connector cable during normal operation of the stimulator will produce inductive
components and may, if very short stimulation pulses are being used, lead to a reduction of stimula-
tion performance or to faulty measurement of the actual stimulation current. Misinterpretations of the
reported values can be the consequence.
In case of battery leakage, the device should not be operated anymore for security reasons the device
must be returned to the manufacturer for proper cleaning.
Avoid unclean connections. Water and dirt will deteriorate the contact properties of the plug-in connec-
tions and lead to unintentional short-circuits or leakage-currents. These may lead to partial- or even total
diversion of the stimulation currents, which will cause the stimulation effect to decline, or even to fail
completely. In this case, the device cannot display the actually fl owing patient current correctly any more.
To avoid damaging the MultiStim SWITCH and its accessories, do not use aggressive cleaning agents,
further details may be found under item “Cleaning and Disinfection of the Device”. Check all accesso-
ries in regular intervals. The insulation of the lines and hardware connections may show no damages.
The User Instructions are to be followed for the operation of the MultiStim SWITCH and the corre-
sponding accessories. When sterile accessories are being used, please always provide for sterile environ-
mental conditions.
Avoid unintentional bone contact with the stimulation cannula, since the cannula may thereby be
substantially damaged which may consequently cause a traumatization of the tissue.
Keep the accessories and MultiStim SWITCH away from live / current bearing objects. The electrostatic
and electromagnetic fi elds radiated therefrom may have an infl uence on the stimulation result, and
these themselves may even lead to unwanted stimulation effects in the tissue.
The device, the connector cables and the plugs must be kept completely clean and dry before and
during the application. Moisture and uncleanness will affect the function of the nerve stimulator and/or
the stimulation result.
Please note the position of metal implants in the tissue (e.g. plates or electrode cables). They may
perhaps conduct the stimulation signals to other locations and can cause detrimental effects there.
Implanted electronic equipment may be impaired by the stimulation current, which in turn will lead to
a malfunctioning of these implants or may even destroy them.
To avoid malfunctions of the MultiStim SWITCH, please check all functions before the intervention and
make sure that the accessories are suitable for the application. The accessories used must correspond to
safety class type BF.
To protect the patient from electrophysiological shock by electrostatic discharge (ESD), it is necessary to
wear corresponding clothing and to move about in an appropriately protected environment. An elec-
trostatic discharge (ESD) can cause extremely high current densities to appear at the tip of the cannula,
which can damage the surrounding tissue.
XS190174B MultiStim SWITCH GB.indd 27
XS190174B MultiStim SWITCH GB.indd 27
12.03.10 13:53
12.03.10 13:53
