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VPD 3in1 User Manual

Multiparameter for self testing use
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USER MANUAL

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Summary of Contents for VPD 3in1

  • Page 1 Multiparameter for self testing use USER MANUAL...

  • Page 2: Table Of Contents

    Contents: •.3in1..meter •.3in1. glucose.strips.10.pcs •.Lancing.device.1.pc •.Sterile.lancets.10.pcs. •.User.manual •.Rapid.guide Introduction..................1 System.................. 1 Meter..................2 Display................... 3 Mode..................3 The.measurement................4 Coding.the.meter..............4 How.to.obtain.a.drop.of.blood............ 6 Application.of.blood..............7 Procedure.to.test.glucose............7 Procedure.to.test.cholesterol.and.triglycerides......8 Warnings....................9 Strips....................10 Control.solutions................11...

  • Page 3: 3In1

    System Thank.you.for.choosing.the.3in1..system. 3in1..is.a.new.system,.useful.for.the.monitoring.of.glucose,. cholesterol.and.triglycerides.in.the.blood. 3in1..has.two.different.technologies: •.amperometric,.with.3in1..glucose.electrodes.strips. •.reflectometric,.with.3in1..cholesterol.and.triglycerides.strips. Self–monitoring.of.glucose,.cholesterol.and.triglycerides.could.be. helpful,.but.the.treatment.to.be.applied.should.be.agreed.with.the. physician..The.3in1..system.is.plasma-calibrated. Information about system line 3in1. The.3in1..system.line.includes.everything.necessary.for.self.testing: •.3in1..meter •.3in1..strips.10.pcs •.Lancing.device.1.pc •.Sterile.lancets.10.pcs •.3in1..control.solutions.-.available.by.extra.order •.3in1..data.manager.software.-.by.special.request. Read.carefully.the.instructions.for.use.inside.the.box.of.3in1..strips. that.you.want.to.use.and.read.carefully.the.instructions.for.the.use.of. the.lancing.device.that.are.included.in.the.3in1..meter.box.

  • Page 4: Meter

    Meter Display.–.shows.test.results,.messages,.and.results. stored.in.memory. Power.Button.–.press.this.button.to: Turn.on.the.meter.or.turn.off.the.meter. Enter.the.SET.mode.in.the.STANDBY.mode. Go.to.the.next.step.in.the.SET.mode. Exit.the.SET.mode.and.enter.the.STANDBY. mode. “+”.Button.--.press.this.button.to: Enter.the.MEMORY.mode. Recall.previous.stored.results.in.the.MEMORY. mode. Change.parameters.displayed.and.increase. values.in.the.SET.mode. “-”.Button.–.press.this.button.to: Enter.the.MEMORY.mode. . R ecall.next.stored.results.in.the.MEMORY. mode. . C hange.parameters.displayed.and.decrease. values.in.the.SET.mode. . R eset.the.test.results. Test.Strip.Slot.–.insert.test.strip.here..The.meter. automatically.enters.the.TEST.mode.when.a.test. strip.is.inserted. PC.Connector.–.transfers.data.from.the.meter.to.a. computer. Cover.–.open.this.for.cleaning.. Battery.Cover. Put.your.finger.on.this.to.let.the.battery.cover.slide. Data-Chip.Slot.–.insert.the.data-chip. Ejector.–.press.to.discharge.the.used.strip.

  • Page 5: Display

    Display Data-chip.inserting Meter.mode Low.battery.warning Test.results.and.messages Unit.of.measurement Test.analytes Abnormal.temperature.warning Time Day.and.month Alarm Mode The.3in1..meter.has.three.modes. You.can.check.the.present.mode.of.the.meter.by.seeing.the.top.of display. 1. Standby Mode Press.and.release.the.power.button. A.strip-shaped.symbol.will.twinkle.and.the.meter.will.display.the.data. chip.number,.time.and.date. 2. Memory Mode Press.and.release.the.“+”.or.“-”.button.in.the.standby.mode. The.meter.will.display.a.“MEM”.symbol.on.the.top.of.the.display. 3. Set Mode Press.and.release.the.power.button.in.the.standby.mode. Press.again.the.power.button.for.3.seconds. The.meter.will.display.a.“SET”.symbol.on.the.top.of.the.display.

  • Page 6: The.measurement

    Coding the meter ....Attention!..The.code.chip.is.not.necessary.for.glucose.measuring. The.3in1..meter.uses.a.data-chip.that.is.inside.the.strips box..It.will.be.necessary.to.change.the.data-chip.in.the.following cases: before.using.a.new.strips.box, when.you.want.to.change.the.analyte. Remove.the.data-chip.from.the.strips.box. Insert.the.data-chip.in.the.proper.space.in.the.back.part.of.the. meter. Gently.press.the.data-chip.up.to.the.complete.insertion.
  • Page 7 Press.power.button.and.check.the.three.digit.number.is.the.same. of.the.one.printed.on.the.strips.vial. If.the.data-chip.is.not.inserted,.it.is.impossible.to.perform.the. measurement. Analytes:. CH = CHOLESTEROL (GREEN) TGL=TRIGLYCERIDES (YELLOW)

  • Page 8: How.to.obtain.a.drop.of.blood

    When switching on the meter, check that the date and the hour are correct. How to obtain a drop of blood To.perform.a.measurement.with.the.3in1..system,.it.is.necessary.to withdraw.a.drop.of.capillary.blood.by.following.the.procedure: •. Wash.the.hands.with.warm.water.to.increase.blood.circulation.in. the.fingers.to.simplify.the.withdrawal.of.blood. •. Dry.your.hands. •. Check.that.the.finger.to.be.pricked.is.completely.dried. •. Prepare.the.lancing.device.that.is.inside.the.3in1..kit.by.inserting. the.sterile.lancet. Read.carefully.the.instruction.for.use.of.the.lancing.device. contained.in.the.meter.kit. Use.a.new.lancet.for.each.prick.and.use.the.lancing.device.only.on. yourself. Before.insertion,.verify.that.the.lancets.and.the.protection.of.the. lancets.are.intact. Only.an.intact.lancet.protection.can.guarantee.that.the.lancet.remains.

  • Page 9: Application.of.blood

    Application of blood Read.carefully.the.instructions.for.the.use.strips.that.you.want.to.use. to.perform.the.measurement.. Press.the.Power.button..Insert.data-chip. only.for.cholesterol.and.triglycerides. measurements..The.symbol.that.appears. on.the.display.(3in1..for.glucose.or.a. three.digit.number.for.cholesterol.and. triglycerides).has.to.match.the.symbol. printed.on.the.strips.vial..If.they.do.not. match,.contact.Customer.Service. Glucose.measurements.do.no.require. coding.. Take.a.strip.from.the.vial.and.insert.it.in.the.meter.with.the.printed. or.coloured.part.on.the.upper.side..You.will.hear.a.click.and.the. meter.will.emit.an.acoustic.signal.. 3. Procedure.to.test.glucose: 3.a.Perform.the.prick.on.the.finger.with.the. lancing.device.. Apply.a.drop.of.blood.on.the.part.of.the. strip.that.comes.outside.the.meter.. Let.the.strip.aspirate.the.blood.up.to.see. the.moving.segments.on.the.display..If the volume is not sufficient the measurement does not start.

  • Page 10: Procedure.to.test.cholesterol.and.triglycerides

    Procedure.to.test.cholesterol.and.triglycerides 3.b.Sit.down.for.one.minute.with.the.arm.along.the.body.. Massage.the.finger.to.be.pricked.in.order.to.increase.the.blood. flow.. Prick.the.finger,.remove.the.first.drop.with.sterile.gauze.and. gently.press.the.finger.to.obtain.a.second.drop..Without.touching. and.pressing.the.finger.on.the.strip,.apply.the.drop.on.the.white. circular.area.of.the.strip.that.comes.out.of.the.meter.. Wait.until.moving.segments.will.appear.on.the.display.. The.meter.will.emit.an.acoustic.signal. and.the.result.will.be.visualised.on.the. display.and.automatically.stored.in.the. memory.of.the.meter.(refers.to.the. instruction.for.use,.that.you.are.using. to.know.the.reading.time). Press.the.ejector.key.to.remove.the.strip.that.you.used,.pointing. the.meter.down.for.the.low.

  • Page 11: Warnings

    Warnings If.the.results.obtained.do.not.correspond.to.the.well-being.of. the.user,.proceed.with.a.check.up.of.the.3in1. instrument.and. contact.your.physician..If.the.results.are.too.high.(Hi).or.too.low. (Lo),.contact.your.physician.immediately. When.the.measuring.is.finished,.it.is.possible.to.turn.OFF.the.3in1. meter..The.instrument.will.shut.down.automatically.after.60.seconds.if. not.used.for.other.operations. The.measured.value,.along.with.date.and.time,.will.be.saved.in. position.1.in.the.memory.of.the.instrument.. The.values.previously.measured.will.be.saved.in.positions.2,.3.etc.. starting.from.the.most.recent..Descriptions.on.how.to.recall.data.from. the.memory.and.how.to.erase.memorised.values.are.presented.on. page.12. Strips.and.used.materials.have.to.be.properly. disposed,.avoiding.contamination..The.meter. has.to.be.disposed.following.the.rules.regarding. electric.and.electronic.waste.disposal. In.a.laboratory.and.in.a.hospital,.the.procedures. of.biological.safety.must.be.followed.when. handling.potentially.infected.material,.in. particular.when.measurements.are.performed. on.different.patients. To.avoid.infections.clean.the.instrument.regularly. and.dispose.of.the.used.strips.in.a.way.that. there.is.no.risk.of.infections.for.other.people.

  • Page 12: Strips

    Strips The.correct.use.of.3in1..strips.is.very. important.for.obtaining.accurate.results.. Therefore.it.is.important.to.keep.in.mind.the. following:. •. The.strips.are.sensitive.to.light.and. humidity:. keep.the.strips.only.in.their.original.vial. •. Protect.the.vial.from.direct.sunlight.and. keep.at.a.temperature.between.5.and. 30 °C.(41.-.86°F). •. Use.the.strips.immediately.after.removing. them.from.the.vial.and.close.the.vial. immediately •. The.strips.must.not.be.used.after.the.expiry. date. •. Write.the.date.of.the.first.opening.on.the. vial:. the.strips.must.be.used.within.90.days.after. the.vial.has.been.opened. •. Do.not.use.strips.that.are.damaged. •. Carefully.read.the.instructions.contained.in. the.package.of.strips. •. Take.measurements.only.with.original. 3in1..strips.

  • Page 13: Control.solutions

    Control Solutions Read.carefully.the.instructions.for.use.of.the.control.solution.that.you. want.to.use. It.is.possible.to.check.the.working.of.the.3in1..meter.by.using.the. 3in1..control.solutions. The.control.solutions.can.be.obtained.as.a.separate.accessory. through.specialised.retailers. The.control.solution.is.applied.on.the.strip.just.like.blood. When.testing.is.done.with.the.control.solution,.the.obtained.result. must.be.within.the.interval.as.shown.on.the.label.of.the.strip’s.vial. In.this.way,.it.is.possible.to.learn.how.to.use.the.3in1..properly and.at.the.same.time.to.check.if.it.is.functioning.properly. Write.the.date.of.opening.on.the.vial.when.the.solution.is.opened.for the.first.time. The.control.solution.must.be.used.within.90.days.from.first.opening,. if.the.expiry.date.is.valid. When.is.it.necessary.to.perform.a.check-up.with.control.solutions: •. When.suspecting.a.possible.defect.of.the.3in1..meter. •. When.suspecting.that.the.possibility.of.a.malfunction.or.wrong. measurement. The.result.obtained.with.the.control.solutions.has.to.be.deleted.by. the.memory.of.the.meter.in.order.to.not.interfere.with.the.average. calculation.of.the.glycaemia.

  • Page 14: Memory.functions

    Memory functions: recalling and deleting results from the memory The.3in1..meter.stores.up.to.500.test.results.for.all. analytes,.letting.you.to.review.them.in.the.order.from. the.most.recent.(“1”).to.the.oldest.(“500”). If.you.insert.the.glucose.data-chip.in.the.meter,.you. allow.to.recall.only.previous.glucose.test.results..The. same.applies.for.other.analytes.. Press.and.release.the.“+”.or.“-”.button.in.the. STANDBY.mode.. The.meter.will.enter.MEMORY.mode.and.the. average.of.test.results.is.displayed.. While.pressing.the.“+”.or.“-”.button,.memory. number.will.be.displayed..If.you.hold.down.the. “+”.or.“-”.button,.the.meter.scrolls.quickly.and. only.memory.positions.are.displayed..Result.is. not.shown.until.you.release.the.button..When. releasing.the.“+”.or.“-”.button,.the.corresponding. result.will.be.displayed.. Repeat.step.2.to.see.the.remaining.stored.results.. Keep.the.power.button.pressed.and.then.press. the.“-”.button.for.1.second.to.delete.one.test. result.stored.in.the.meter.. Press.“-”.button.for.5.seconds.together.with.the. power.button.to.delete.all.test.results.stored.in.the. meter.

  • Page 15: General.settings

    Modification of settings Press.and.release.the.power.button.to.select.the. month.. Press.and.release.the.“+”.or.“-”.button.up.to.get. the.correct.month.. Press.and.release.the.power.button.to.select.the. day.. Press.and.release.the.power.button.to.change.. Press.and.release.the.power.button.to.choose.the. date.format.. Press.and.release.the.“+”.or.“-”.button.to.choose. between.month-day.(mm-dd).or.day-month.(dd- mm).. Press.and.release.the.power.button.to.change.the. year..Press.and.release.the.“+”.or.“-”.button.up.to. reach.the.current.year.. The.meter.enables.to.change.the.year.from.2011. to.2025.. Press.continuously.the.power.button.for.3. seconds..The.meter.will.enter.in.the.SET.mode. and.it.will.be.possible.to.change.the.hour.. Press.and.release.the.“+”.or.“-”.button.up.to.reach. the.correct.hour.. Press.and.release.the.power.button.to.change.the. minutes..Press.and.release.the.“+”.or.“-”.button. up.to.get.the.correct.minutes..

  • Page 16: Setting.the.acoustic.signal

    Press.and.release.the.power.button.to.change. the.hour.format..Press.and.release.the.“+”.or.“-”. button.to.choose.between.12.or.24.hours.. Press.and.release.the.power.button. to.change.the.unit.of.measurement.. Press.and.release.the.“+”.or.“-”. button.to.choose.between.mg/dL. and.mmol/L.. Press.and.release.the.power.button.to.select. how.many.days.will.be.included.in.the.average. result..Press.and.release.the.“+”.or.“-”.button.up. to.get.the.desired.number.of.days.(0,7,14,21,28. days.-“0”.means.that.the.meter.will.not.show.any. average.of.the.measurements). Setting the acoustic signal Switch.on.the.meter.and. continuously.press.the.power. button.to.enter.in.the.SET.mode.. Press.and.release.the.power.button. up.to.see.“bp”.fixed.and.“On”. blinking.on.the.display. Press.the.“+”.or.“-”.button.to. activate.or.deactivate.the.acoustic. signal. Setting the alarms Follow.these.instructions.to.set.the.alarms: Press.and.release.the.power.button.. Press.the.power.button.continuously.to.enter.in. the.SET.mode..Press.and.release.up.to.see.the. icon.of.the.alarm.fixed.and.“0”.blinking.

  • Page 17: Enabling.data.transfer.to.pc

    Press.the.“+”.or.“-”.button.to.select.the.number.of. the.alarm.to.be.set.(0,.1,.2,.or.3). Press.the.power.button.again.to.select.the.hour. and.the.minutes.related.to.the.alarms.that.you.are. setting. You.can.exit.by.using.the.SET.mode.at.any. moment.by.pressing.continuously.the.power. button.for.three.seconds.. The.alarms.are.not.activated.if.they.are.set.to. 12.00.or.0.00. Enabling data transfer to PC All.the.test.results.that.are.stored.in.the.3in1..meter.can. be.downloaded.to.a.computer. Install.the.software.according.to.the.manufacturer’s.instructions. Insert.the.cable.into.the.USB.port.of.the.computer.and.the.jack.of. the.cable.into.the.meter. Press.and.release.the.power.button..“PC”.will.appear.on.the. meter’s.display. Set.up.your.computer.software.to.receive.information.from.the. meter.. After.the.data.has.been.transferred,.you.can.turn.off.the.meter.by. pressing.the.power.button.and.removing.the.jack.cable.from.the. port.of.the.meter.

  • Page 18: Maintenance.and.preservation.conditions

    For. taking. measurements. on. different. people,. like. in. a. hospital. for. example,. clean. the. instrument. after. every. measurement. with. a. 70%. alcohol. solution. before. proceeding.with.the.next.measurement. Preservation and measuring conditions To.assure.the.accuracy.of.each.measurement,.it.is.important.to.meet. the.following.conditions. The.measurement.with.3in1..strips.has.to.be.performed.between. 10.and.40°C.(50-104°F)..The.3in1..kit.(meter.and.strips).may.not. be.stored.at.temperature.lower.than.5°C.(41°F).or.higher.than.30°C. (86°F). Note. If.the.instrument.is.too.cold.or.too.hot.(e.g..after.being.in.a.car.at. very.low.or.high.temperatures),.allow.it.to.cool.down.or.to.heat. up.slowly.at.room.temperature.(about.20.minutes).

  • Page 19: Error.messages

    Error messages Error. Problem Solution message The.temperature.is.out. Place.the.instrument.in.an.area. of.the.allowed.range. with.temperature.between. 10°C.(50°F).and.40°C.(104°F). and.wait.for.the.instrument.to. equilibrate.with.the.external. temperature,.before.performing. the.measurement. The.strip.is.used.or. Use.a.new.strip.to.perform.the. the.reactive.area.is. measurement. coloured. The.blood.was.applied. Take.a.new.strip,.insert.it.in. on.the.strip.before. the.instrument.and,.only.after. waiting.for.the.drop. visualised.blinking.drop.on.the. blinking.on.the.display. display,.aspirate.the.blood.on. the.strip. The.reading.window. Open.the.plastic.cover.where.you. is.dirty. insert.the.strip.and.clean.the.glass. window.using.only.water..Dry.the. glass.without.scratching.it..Do.not. use.solvents.or.soap..Close.the. plastic.counter.and.repeat.the.test. The.strip.is.removed. Switch.off.the.meter.by.using. from.the.meter.without. the.power.button..Insert.the.strip.

  • Page 20: Error Messages

    Error messages Error. Problem Solution message Data-chip.error Remove.the.data-chip.and.insert.it. again..If.E05.still.remains,.contact. 3in1. .Customer.Service. There.is.not.enough. Repeat.the.test.and.apply.more. blood blood. The.data-chip.is.not. Insert.the.data-chip.corresponding. inserted to.the.strips.that.you.want.to.use. The.result.is.lower. If.the.result.does.not.correspond. than.the.limit.of.that. to.the.personal.sensations,.repeat. parameter.(see.also. the.test,.applying.a.big.drop.of. instructions.for.use.of. blood... the.strips) If.LO.is.obtained.again,.contact. your.physician.for.additional. information.
  • Page 21 Error messages Error. Problem Solution message Value.is.higher.than.the. Immediately.contact.your. limit.of.reading.of.that. physician.and.repeat.the.test.in.a. parameter. hospital.laboratory. Get.new.batteries. Replace.the.batteries.before. taking.a.measurement. Check.expiry.date.of.the.strips. and.use.new.strips.to.perform.the. measurements..Blinking.result.is. not.saved.in.the.memory.

  • Page 22: Change.of.batteries

    Changing the batteries The.3in1..meter.houses.two.3V.lithium.batteries.(type.CR.2032).. If.the.battery.icon.is.blinking,.the.charge.is.low.and.the.battery.must. be.replaced.before.taking.a.measurement. Always.insert.new.batteries.and.not.a.used.one.. Shut.down.the.instrument.before.removing.the.batteries.. Check.the.new.batteries.to.see.if.they.apply. How.to.change.the.batteries: •. Open.the.sliding.rear.panel.of.the.instrument.(1). •. Remove.the.batteries.from.the.plastic.holder.(2). •. Place.the.new.batteries.so.that.the.type.is.readable..The.negative. side.of.the.batteries.must.be.at.the.top.(3). •. Close.the.back.cover.until.a.click.is.heard. Flat.batteries.can.be.disposed.of.in.recycling.centers. NOTE. If.the.batteries.are.replaced.or.simply.removed.for.more.than.60. seconds,.it.is.necessary.to.set.time.and.date.again.

  • Page 23: Warranty

    Information on the conditions of warranty VPD,.Bled,.d.o.o..company.grants.to.the.customer.that.the. instrument.will.be.free.of.material.defects.and.manufacturer.handling. for.3.years.starting.from.the.purchasing.date..During.such.period,. VPD,.Bled,.d.o.o..should.replace.the.defected.instrument.with.an. equivalent.version.or.the.same.model.after.verifying.the.defect. Such.warranty.is.subject.to.exception.and.limitation.as.described. below..The.warranty.is.limited.to.the.replacement.due.to.defects. in.some.parts.and.handling..Instruments.with.defects.caused.by.. improper.use,.alteration,.negligence,.technical.assistance.performed. by.unauthorised.personnel,.or.due.to.an.accident,.abuse.or.using. strips.that.differ.from.the.original.3in1..strips.will.not.be.replaced. VPD,.Bled,.d.o.o..reserves.the.right.to.apply.technical.modifications. to.3in1..meter.without.the.obligation.to.insert.such.specifications.to. already.marketed.products. Other.warranty.will.be.granted.for.this.product.if.the.replacement. option.described.above.shall.not.deem.possible. The.responsibility.for.special,.indirect.or.consequential.damage.is. excluded.
  • Page 24 Name Surname Street City.&.Postal.code Telephone E-mail Serial.number Date.of.purchase Date Signature Send.to: VPD,.Bled,.d.o.o. Pot.na.Lisice.4,.4260.Bled,.Slovenia,.EU...

  • Page 25: Symbols

    Symbols used on the packaging Follow.instructions In-Vitro-Diagnosticum Use.until... Batch.number... Store.at.temperatures 3V.direct.current.and.battery.type CE.mark Do.not.dispose.the.instrument.in.urban.waste..Collect. separately,.specifically.for.electric.and.electronic. waste.or.give.the.instrument.to.the.distributor.when. you.buy.a.new.one.or.when.you.want.to.substitute.it.. Please.refer.to.local.updated.regulations.

  • Page 26: Performance

    10-600.mg/dL.(0.6-33.3.mmol/L).glucose.electrodes 130-400.mg/dL.(3.3..-.10.2.mmol/L).cholesterol 50-500.mg/dL.(0.56-5.6.mmol/L).triglycerides Power.source: 2x3V.lithium.button.cell,.type.CR.2032.. The.battery.can.be.used.for.approx..1.year.with.3. measurements.per.day.(approx..1000.measur.) Dimensions: 97.mm.–.length 49.mm.–.height 20.5.mm.-.width Weight: 65.g.(incl..battery) Display: Temperature.limits: 10.to.40°C.(50°F.to.104°F) Humidly.limits: 0%.to.90%.relative.humidity.(non-condensing) Memory.capacity: 500.measured.values.with.time.and.date Interface.for.data. Connecting.cable processing: Special.requirements. The.CE.mark.on.the.device.indicates.that.it.complies. for.electromagnetic. with.the.requirements.of.the.EC.directives.89/336/EEC. radiation: relating.to.electro-magnetic.compatibility.73/23/EEC. for.electrical.equipment.intended.for.the.use.in.areas.of. specific.voltage.levels Hint.for.Healthcare. The.appropriate.legal.provisions.apply.for.the.use.of. 3in1. Professionals: ..The.accuracy.of.the.instrument.should.be. checked.after.3.years. Waste.management. Please.refer.to.local.updated.regulation! disposal:...
  • Page 28 VPD, Bled, d.o.o. Pot na Lisice 4, 4260 Bled Slovenia, EU tel.: +386 4 574 50 70 fax: +386 4 574 50 71 email: info@3in1.si web: www.3in1.si EDitioN DAtE AND LASt REViSioN DAtE: 2014-02-01...

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