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Precautions/adverse Reactions
. ● Isolated.cases.of.skin.irritation.may.occur.at.the.site.of.electrode.placement.following.long-term.
application.
. ● Stimulation.should.be.stopped.and.electrodes.removed.until.the.cause.of.the.irritation.can.be.de-
termined.
. ● Effectiveness.is.highly.dependent.upon.patient.selection.by.a.person.qualified.in.the.management.
of.pain.patients.
. ● If.the.device.treatment.becomes.ineffective.or.unpleasant,.stimulation.should.be.discontinued.until.
reevaluation.by.a.physician/clinician.
. ● . A lways.turn.the.device.off.before.applying.or.removing.electrodes.
. ● Skin.irritation.and.electrode.burns.are.potential.adverse.reactions.
DANGER
The.device.does.not.have.AP/APG.protection..Explosion.hazard.is.possible.if.used.in.the.presence.of.
explosives,.flammable.materials.or.flammable.anesthetics..Caution.should.be.used.when.applying.the.
device.to.patients.suspected.of.having.heart.disease..Further.clinical.data.is.needed.to.show.if.there.
are.adverse.side.effects.on.those.with.heart.disease.
COMTENS III _3 languages.indd 6
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2013/2/23 AM 09:11:08
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