Apex Digital com-TEns111 User manual

CE
com-TE n s 111
Transcutaneous
Ele€trical Nerve
Stimulation
Model: GM3AlOT/GM3AlOT (O)
Care for a Healthy Life
0120
Please read the instruction manual befare use.

Introduction......................................................................................1
Introducción.....................................................................................22
Introdução.......................................................................................42

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SYMBOLS
Manufacturer
Authorised.representative.in.the.European.Community
0 1 2 0
CE.mark.and.notified.body.registration.number,.the.Annex.II.(ex-
cluding.section.4).article.3.of.EC.directive.93/42/EEC.have.been.
met..
“BF”.symbol,.indicate.this.product.is.according.to.the.degree.of.
protecting.against.electric.shock.for.type.BF.equipment..
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GENERAL DESCRIPTION
Electric.myostimulation.has.proven.its.high.value.as.a.method.of.pain.therapy.and.is.a.great.help.to.
the.experienced.therapist.
With.some.indications,.physicians.can.prescribe.unit.to.patients.for.the.use.at.home.
The.unit.is.a.dual-Channel.electric.stimulator.for.active.treatment.application,.which.output.as.well.as.
an.8-bit.micro.computer.for.controlling.the.system.
The.electronics.of.the.unit.create.electric.impulses:.the.intensity,.duration,.frequency.per.second.and.
modulation.of.these.impulses.can.be.adjusted.through.the.switch.or.knob.
SYSTEM COMPONENTS
Your.device.may.include.the.following.components.or.accessories:
● Unit
● Carrying case
● Lead wires / Electrodes
● 9-volt battery
● Operation Manual
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WARRANTY
This.device.carries.a.one-year.warranty.from.the.date.of.purchase..The.warranty.applies.to.the.de-
vice.and.necessary.parts.and.labor.relating.thereto..The.distributor.reserves.the.right.to.replace.or.
repair.the.unit.at.their.discretion.
The.warranty.does.not.apply.to.electrode,.battery,.lead.wires,.carrying.case,.damage.resulting.from.
failure.to.follow.the.operating.instructions,.accidents,.abuse,.alterations.or.disassembly.by.unauthor-
ized.individuals.
INDICATIONS AND CONTRAINDICATIONS
Read.the.operation.manual.before.using.the.device.
Federal.law.(USA).restricts.this.device.to.sale.by.or.on.the.order.of.a.physician..Observe.your.phy-
sician’s.precise.instructions.and.let.him.show.you.where.to.apply.the.electrodes..For.a.successful.
therapy,.the.correct.application.of.the.electrodes.is.an.important.factor.
Carefully.write.down.the.settings.your.physician.recommended.
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Indications for use
This.device.is.a.prescription.device.and.only.for.symptomatic.relief.of.chronic.intractable.pain.
Contraindications
●. Any.electrode.placement.that.applies.current.to.the.carotid.sinus.(neck).region.
●. Patients.with.implanted.electronic.devices.(for.example,.a.pacemaker).or.metallic.implants.should.
not.undertake.
●. Any.electrode.placement.that.causes.current.to.flow.transcerebrally..(through.the.head).The.use.of.
unit.whenever.pain.symptoms.are.undiagnosed,.unit.etiology.is.determined.
●. The.use.of.TENS.whenever.pain.syndromes.are.undiagnosed,.until.etiology.is.established.

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WARNINGS AND PRECAUTIONS
Warnings
●. The.device.must.be.kept.out.of.reach.of.children.
●. The.safety.of.device.for.use.during.pregnancy.or.delivery.has.not.been.established.
●. Do.not.place.electrodes.on.front.of.the.throat..This.may.result.is.spasms.of.the.laryngeal.and.pha-
ryngeal.muscles.
●. Do.not.place.the.electrodes.over.the.carotid.nerve.
●. The.device.is.not.effective.for.pain.of.central.origin.(headaches).
●. The.device.may.interfere.with.electronic.monitoring.equipment.(such.as.ECG.monitors.and.ECG.
alarms).
●. Electrodes.should.not.be.placed.over.the.eyes,.in.the.mouth,.or.internally.
●. These.devices.have.no.curative.value.
●. TENS.devices.should.be.used.only.under.the.continued.supervision.of.a.physician.
●. TENS.is.a.symptomatic.treatment.and.as.such.suppresses.the.sensation.of.pain.which.would.oth-
erwise.serve.as.a.protective.mechanism.

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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.
●. .Always.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.

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ABOUT THE DEVICE
Your.device.offers.two.controllable.output.channels..This.device.creates.electrical.impulses.whose.
amplitude,.width,.rate.and.modulation.can.be.altered.with.the.switches.or.knobs..The.device.controls.
are.very.easy.to.use.and.the.slide.cover.protects.accidental.changes.in.settings.
GM3A10T: With Timer GM3A10T(0): Without Timer

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THE DEVICE CONTROLS
Slide cover
A.cover.conceals.the.controls.for.Mode,.Time.(for.GM3A10T.only),.Width,.Rate..Press.the.topside.of.
the.cover.and.pull.down.in.order.to.open.the.cover.
Intensity
The.intensity.knobs.are.located.on.the.top.of.the.unit.for.the.strength.adjustment.of.the.stimulation.and.
also.function.as.ON/OFF.controls.
Mode
The.Mode.switch.is.used.to.select./.set.the.type.of.treatment.utilized..The.three.modes.are.Burst.(B),.
Continuous.(C),.Modulation.(M).
TIME (for GM3A10T only)
Treatment.Time.of.device.can.be.pre-select./.set.with.Time.switch..There.are.two.programs.fixed.dura-
tion.of.30.and.60.minutes.and.one.program.of.continuous.output..Set.the.switch.to.the.position.desired.
To.reset.timer,.turn.both.channels.off...When.you.are.ready.to.begin.another.treatment.cycle.(at.least.
rest.for.7.seconds),.turn.the.unit.on.as.normal...The.timer.will.be.reset.to.its.current.setting.
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WIDTH
The.pulse.Width.controller.regulates.the.pulse.width.for.both.channels.
RATE
The.pulse.Rate.controller.regulates.the.number.of.pulse.per.second.for.both.channels.

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ATTACHING THE LEAD WIRES
The.lead.wires.provided.with.the.device.insert.into.the.jack.sockets.located.on.top.of.the.unit..Holding.
the.insulated.portion.of.the.connector,.and.pushing.the.plug.end.of.the.wire.into.one.of.the.jacks..After.
connecting.the.wires.to.the.stimulator,.attach.each.wire.to.an.electrode.
Lead.wires.provided.with.the.device.are.compliant.with.mandatory.compliance.standards.as.set.forth.
by.the.FDA.
Note: Use carefully when you plug and unplug the wires. Pulling on the lead wire instead of its insulated
connector may cause wire breakage.
Caution: Never insert the plug of the lead wire into an AC power supply socket.
ELECTRODE SELECTION AND CARE
Your.physician/practitioner.should.decide.which.type.of.electrode.is.best.for.your.condition..Follow.
application.procedures.outlined.in.electrode.packaging.to.maintain.stimulation.and.prevent.skin.irrita-
tion..The.electrode.packaging.will.provide.instruction.for.care,.maintenance.and.proper.storage.of.your.
electrodes.
Be.sure.to.use.the.electrodes.provided.by.the.manufacturer.and/or.the.similar.FDA.legally.marketed.
electrode.in.particular.the.same.cross.section.area.

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TIPS FOR SKIN CARE
Good.skin.care.is.important.for.comfortable.use.of.your.device.
●. .Always.clean.the.electrode.site.with.mild.soap.and.water.solution,.rinse.well,.and.blot.dry.thoroughly.
prior.to.any.electrode.application.
●. .Any.excess.hair.should.be.clipped,.not.shaved,.to.ensure.good.electrode.contact.with.the.skin.
●. .You.may.choose.to.use.a.skin.treatment.or.preparation.that.is.recommended.by.your.physician..
Apply,.let.dry,.and.apply.electrode.as.directed..This.will.both.reduce.the.chance.of.skin.irritation.and.
extend.the.life.of.your.electrodes.
●. .Avoid.excessive.stretching.of.the.skin.when.applying.electrodes,.this.is.best.accomplished.by.ap-
plying.the.electrode.and.smoothly.pressing.it.in.place.from.the.center.outward.
●. .When.removing.electrodes,.always.remove.by.pulling.in.the.direction.of.hair.growth.
●. .It.may.be.helpful.to.rub.skin.lotion.on.electrode.placement.area.when.not.wearing.electrodes.

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CONNECTING THE DEVICE
1. Prepare the Skin
Prepare.the.skin.as.previously.discussed.and.according.to.instructions.provided.with.your.electrodes..
Before.attaching.the.electrodes,.identify.the.area.in.which.your.physician/practitioner.has.recommend-
ed.for.electrode.placement.
2. Connect lead wires to the electrodes
Connect.the.lead.wires.to.the.electrodes.before.applying.the.electrodes.to.the.skin.
Note: Be sure both intensity controls for Channel 1 and 2 are turned to the “OFF” position.
3. Place Electrodes on Skin
Place.the.electrodes.on.the.skin.as.recommended.by.your.clinician.
4. Insert Lead Wire Connector to device
Plug.end.of.lead.wire.into.the.channel.output.receptacle.to.be.used,.pushing.plug.in.as.far.as.it.will.go.
5. Select Treatment Settings
Check.and.be.sure.your.unit.is.set.to.the.proper.settings.as.recommended.by.your.physician/practi-
tioner.

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6. Adjusting Channel Intensity Control
Locate.the.intensity.control.knobs.at.the.top.of.the.unit.under.the.cap..Open.the.cap.first,.slowly.turn.
the.intensity.control.knob.for.Channel.1.clockwise.until.you.reach.the.intensity.recommended.by.your.
medical.professional..Always.start.with.the.lowest.step.and.increase.slowly..Repeat.the.same.process.
for.Channel.2,.if.appropriate..Close.the.cap.after.intensity.setting.ok.
If the stimulation levels are uncomfortable or become uncomfortable, reduce the stimulation amplitude to a
comfortable level. Cease stimulation and contact your physician/practitioner if problems persist.
BATTERY INFORMATION
A.9-volt.disposable.battery.is.provided.with.your.unit..Dimming.of.the.indicator.light.signifies.that.the.
battery.should.be.replaced.with.a.new.one.as.soon.as.possible..However,.the.stimulator.will.continue.
to.operate.for.several.more.hours.

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CHANGING THE BATTERY
To.replace.the.battery:
1.. Remove.the.slide.cover.by.pressing.the.top.and.sliding.down.until.it.is.completely.removed.from.
the.unit..This.will.reveal.the.battery.compartment.
2.. Remove.the.discharged.battery.from.the.device.
3.. Place.a.new.battery.in.the.compartment..Note.the.proper.polarity.alignment.indicated.on.both.the.
battery.and.the.compartment.
CLEANING FOR YOUR DEVICE
Your.device.may.be.cleaned.by.wiping.gently.with.a.damp.cloth.moistened.with.mild.soap.and.water..
Never.immerse.the.device.in.water.or.other.liquids.
Wipe.lead.wires.with.a.damp.cloth.as.above.if.they.become.soiled.
To.properly.store.the.device.for.an.extended.period.of.time,.remove.the.battery.from.the.unit..Put.the.
unit.and.accessories.in.the.carrying.case.and.store.in.a.cool,.dry.location.

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TROUBLESHOOTING
If.the.device.does.not.function.properly:
1.. Make.sure.the.battery.is.properly.installed,.or.replace.the.battery..Be.sure.to.observe.proper.
polarity.markings.when.replacing.the.battery..If.the.indicator.light.is.not.on.when.the.unit.is.
turned.on,.replace.the.battery.and.check.again.
2.. If.the.intensity.has.been.adjusted.and.there.is.no.stimulation,.check.that.the.lead.wires.are.
properly.connected.and.the.electrodes.are.in.place..If.the.unit.appears.to.be.functioning.and.no.
stimulation.occurs,.the.lead.wires.or.electrodes.may.need.to.be.replaced.
3.. If.the.battery.appears.to.be.charged.and.the.unit.is.not.functioning,.turn.both.intensity.Control.
Knobs.to.the.OFF.position.(counter-clockwise).for.about.7.sec..Then.gradually.turn.the.intensity.
Control.Knob.clockwise.until.stimulation.is.felt..If.device.still.is.not.working,.turn.the.unit.off.and.
contact.your.distributor.
If.any.other.problems.occur,.please.consult.or.return.the.device.to.your.distributor..Don’t.try.to.repair.
a.defective.device.

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TECHNICAL SPECIFICATIONS
Channel Dual, isolated between channels
Pulse intensity Adjustable 0-80mA peak into 500 Ωload each channel, constant current
Pulse Rate 2Hz-120Hz (adjustable).
Pulse Width 40μs - 260μs (adjustable).
Timer (for GM3A10T
only) 30, 60 minute and continuous mode selectable

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Function Modes:
TENS
BCycle Bursts, 2Bursts/sec, 9pulses/Burst, 100Hz, width is adjustable.
CContinuous mode. Pulse rate, pulse width and intensity are adjustable.
M
Modulated Width. Pulse width is automatically varied in an interval of
6 seconds.The modulation range of pulse width is from setting value to
35% less than the control setting value, then returns to the setting value.
Rate, width and intensity are fully adjustable.
Wave form Asymmetrical Bi-phasic square pulse.
Voltage 0-110 Volt (Open Circuit).
Max charge per pulse 21 micro-coulombs
Power Source 9-Volt Battery.
Dimensions 95 mm(H) ×61.5mm(W) ×26m(T).
Weight Approx. 120grams (battery included).
All electrical specificationsare ±10% except the amplitude is +/- 20% ( 500Ω load).

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EMC INFORMATION
Recommended.separation.distances.between.portable.and.mobile.RF.communications.equipment.and.the.ME.
equipment
The.ME.equipment.is.intended.for.use.in.an.electromagnetic.in.which.radiated.RF.disturbances.are.controlled..The.
customer.or.the.user.of.the.ME.equipment.can.help.prevent.electromagnetic.interence.by.maintaining.a.minimum.
distance.between.portable.and.mobile.RF.communications.equipment.(transmitters).and.the.ME.equipment.
as.
recommended.below,.according.to.the.maximum.output.power.of.the.communications.equipment.
Rated.maximum.output.power.of.transmitter
WSeparation.distance.according.to.frequency.of.transmitter.m
150 kHz to 80
MHz d=1,2 P80 MHz to 800
MHz d=1,2. P800 MHz to 1.0
GHz d=2,3 P .
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
11.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23