pajunk MultiStim SENSOR Gebrauchsanweisung Seite 44

EN 60 601-1, EN 60 601-1-1, as well as with those of the applicable sub-norms. It is to be taken into
account, that in the most unfavorable case, all leakage currents or the auxiliary patient currents may
perhaps add up cumulatively and the patient may be endangered by these inadmissibly high values,
even if all the rules for the individual facilities have been complied with. It is therefore to be checked in
advance, whether the interconnection of the facilities will perhaps cause the permissive limiting values
to be exceeded. Improper interconnection of equipment and facilities (system formation) can injure the
patient vitally.
The patient himself may not come into contact with metallic objects which are earthed or which have
an electrically conductive connection with other facilities, or which permit capacitive coupling. That is
why we recommend the use of a sufficiently insulating/ non-conductive, antistatic pad on the operat-
ing table.
The MultiStim SENSOR may under no circumstances be operated with instruments and accessories
other than those which have been authorized, supplied or recommended by the manufacturer. Only
PAJUNK accessories have been technically tested with regard to EMC (electromagnetic compatibil-
®
ity). Accessories of other vendors may lead to seriously harming the equipment- and system proper-
ties and may cause lasting impairment to the patient, the user or the equipment.
The simultaneous application of surgical RF-devices will evoke the acute risk of burns caused by touch-
ing the connections of the MultiStim SENSOR, the connector cable, the cannula tip or the adhesive
electrode. It is therefore necessary to disengage all connections to the MultiStim SENSOR and to
remove the stimulation cannula from the tissue before surgical RF-devices are used. The stimulation
cannula with its connector cable acts as an antenna for RF-energy, which may cause the induction
of a very high current density at the tip of the cannula. Nerve fibres in the vicinity may be irrevers-
ibly destroyed. The connected stimulator may simultaneously cause the rectification of the RF-energy,
which will lead to extremely high direct currents and voltage potentials at the electrodes. The direct
current stimulus emitted thereby can be very painful and may trigger intense, irreversible electrophysi-
ological reactions.
To avoid that poor contact of the adhesive electrode will lead to a malpositioning of the stimulation
cannula, please ensure that the adhesive electrode, which functions as a neutral electrode here, is in
sufficiently sound contact with a low tissue impedance. Fatty tissue, hair, uncleanness, repeatedly used
adhesive electrodes and electrodes of inferior quality can influence this tissue impedance adversely and
thereby evoke the risk of nerve damage. We therefore recommend, that the contact surface is selected
carefully: select only muscular areas with sufficient blood perfusion, and clean, shave and degrease the
skin. The position of the adhesive electrode should also not be too far away from the location of the
puncture. However, please avoid the thoracal application of the skin-electrode.
The MultiStim SENSOR should not be used on patients with implanted electrical devices (e.g. cardiac
pacemaker) without previously seeking corresponding medical advice from a specialist. Possibly occur-
ring disturbances of the implanted electrical devices through the stimulating current may constitute a
hazard for the patient. The attachment of electrodes in the vicinity of the thorax (rib cage, heart) may
increase the risk of ventricular fibrillation (cardiac fibrillation).
The stimulator may no longer be used if it displays a direct current- or perhaps a direct voltage-compo-
nent at the output, please send it in for repair.
The patient current should not fall below the following values: 0.3 mA invasive (cannula)
Operate the MultiStim SENSOR only with the genuine, CE-labeled PAJUNK
must be subjected to a visual inspection at regular intervals. The insulation of the patient lines may not
show any damage.
Use only high-quality, commercially available (CE-labeled) single-use ECG-adhesive electrodes with pre-
gelled silver/ silver chloride contacts. For optimal nerve stimulation, please use only electrodes which
are intact and have not dried out.
The adhesive electrodes may not be attached in the area of injuries.
When discarding the MultiStim SENSOR and the listed accessories, the users must comply with the
respective current regulations for the disposal of waste.
Special precautions apply for electric medical equipment with regard to EMC (electromagnetic com-
patibility). Portable and mobile RF-communication facilities may influence the MultiStim SENSOR. This
may lead to a malfunction of the device or of the system.
44
XS190056I.indb 44
accessories. All accessories
®
08.12.17 09:33
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