Roche CoaguChek XS Training Manual
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Roche CoaguChek XS Training Manual

Measures blood-clotting time
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Summary of Contents for Roche CoaguChek XS

  • Page 1 CoaguChek ® System Professional Training Manual for Self-Testing...
  • Page 2 Roche Diagnostics has made every reasonable effort to ensure that all the information contained in this manual is correct at the time of printing. However, Roche Diagnostics reserves the right to make any changes necessary without notice as part of ongoing product development.
  • Page 3 Revisions to this document are provided by Roche Diagnostics when necessary. No part of this document may be reproduced in any form or by any means without prior written consent. Manual version Revision date Changes Version 1.0 November 2009 New document Version 2.0...

  • Page 4: Table Of Contents

    Table of Contents Introduction ......................1 Overview of Warfarin Therapy and the CoaguChek XS System ....3 Materials for User Training ................... 5 User Selection Guidelines ..................7 Overview............................7 Clinical.Study..........................8 Performance.Characteristics.....................9 Training Users for Self-Testing ................13 Preparation............................13...

  • Page 5: Introduction

    Roche.Diagnostics.is.pleased.to.present.this.guide.to.assist.you.in.training. individuals.in.the.use.of.the.CoaguChek .XS.System..The.guide.contains.a.variety. ® of.materials.to.help.you.plan.the.curriculum: •. . a n.overview.of.the.CoaguChek.XS.System. •. . a .description.of.training.mat. e rials.available.from.Roche.Diagnostics •. . a .guide.to.selecting.appropriate.individuals.to.participate.in.self-testing •. . a .suggested.outline.for.the.training.class •. . S kills Checklist.and.Knowledge Test. •. . C ertificate of Completion.to.be.given.to.trainees •. . s uggestions.for.refresher.training. If.you.have.questions,.please.contact.the.Roche.Diagnostics.Technical.Service.

  • Page 7: Overview Of Warfarin Therapy And The Coaguchek Xs System

    Overview of Warfarin Therapy and the CoaguChek XS System OVERVIEW The.CoaguChek.XS.System.from.Roche.Diagnostics.measures.blood-clotting. time.for.people.who.are.taking.anticoagulation.medications.such.as.warfarin. (for.example.Coumadin )..Warfarin.is.an.oral.anticoagulant.that.changes.the. ® formation.of.certain.blood.factors.produced.in.the.liver.in.such.a.way.that. the.clotting.time.is.slowed..(Refer.to.the.latest.warfarin.package.insert.for. contraindications.).The.goal.is.to.prevent.clots.from.forming.or.moving..At.the. same.time,.however,.it.is.important.to.avoid.excessive.anticoagulation,.or.blood. thinning,.which.carries.a.risk.of.hemorrhage. People.on.warfarin.therapy.must.be.monitored.closely.for.two.reasons..First,.as. indicated.above,.it.is.very.important.to.keep.blood.coagulation.time.within.an. optimal.therapeutic,.or.target.range..Second,.each.individual.reacts.differently.to. warfarin,.and.the.medication’s.ability.to.prevent.a.clot.is.affected.by.a.person’s. metabolism,.diet,.and.other.medications. The.variability.of.laboratory.results.due.to.reagent.differences.is.a.common. problem..The.CoaguChek.XS.System.minimizes.the.variability.that.is.seen. with.traditional.PT/INR.assay.reagents..Each.lot.of.test.strips.is.compared.to.a. reference.material.by.Roche.Diagnostics..The.strips.are.then.assigned.a.“code,”. which.standardizes.the.reported.result.via.a.mathematical.algorithm,.thus. minimizing.lot-to-lot.variability..No.manual.calibration.of.the.system.is.required;. each.lot.of.strips.comes.with.a.code.chip.that.stores.the.information.needed.for. automatic.calibration. The.CoaguChek.XS.System.offers.significant.advantages.in.both.convenience.. and.reliability..It.is.a.hand-held,.battery-operated.system.that.can.perform.a.PT/ INR.blood.test.on.a.fresh.whole.blood.sample.from.a.fingerstick..A.test.strip.. is.inserted.into.the.meter.and.a.blood.sample.applied.to.the.strip..The.test.result. is.displayed.in.about.one.minute..The.need.for.trips.to.the.laboratory.or.for. venipuncture.is.virtually.eliminated. The.CoaguChek.System.by.Roche.Diagnostics.has.been.used.successfully.

  • Page 9: Materials For User Training

    Materials for User Training Roche.Diagnostics.has.developed.the.following.materials,.provided.in.the. product.care.kit,.specifically.for.your.use.in.training.new.users.to.self-test.with. the.CoaguChek.XS.System: Training DVD This.program,.which.runs.approximately.15.minutes,.provides.step-by-step. instruction.in.setting.up.the.meter,.preparing.for.and.performing.a.fingerstick. blood.test,.and.cleaning.the.meter..It.is.intended.to.be.the.basis.of.the.training. session..You.may.also.use.the.DVD.as.a.trainee.selection.aid;.individuals.who.are. unsure.of.what.self-testing.involves.may.be.shown.the.DVD.to.help.them.decide. if.they.want.to.go.through.training.and.try.self-testing. CoaguChek XS System A.copy.of.the.manual.is.provided.with.each.CoaguChek.XS.Meter..It.is.intended. User Manual to.be.used.as.an.ongoing.reference.guide.by.users,.but.should.also.be.used.in. training.to.familiarize.trainees.with.the.content.and.structure.of.the.manual.and. make.them.comfortable.with.referring.to.it. Getting Started Guide A.Getting.Started.reference.guide.is.included.in.each.CoaguChek.XS.System.. Care.Kit..It.provides.an.easy.reference.for.testing. Both.the.test.strips.and.lancet.device.have.package.inserts.with.information. Package Inserts about.proper.storage.and.use..It.is.important.to.call.the.users’.attention.to.the. inserts.during.training.

  • Page 11: User Selection Guidelines

    User Selection Guidelines OVERVIEW It.is.important.that.users.be.screened.carefully.before.beginning.a.self-testing. program..The.following.questions.are.designed.to.guide.the.physician,.clinic. nurse,.or.other.healthcare.professional.in.determining.an.individual’s.suitability. for.self-testing. Are specific diagnoses No,.the.specific.diagnosis.is.not.necessarily.indicative.of.who.should.or.should. not.self-test..However,.prior.to.beginning.self-testing,.users.should.be.stabilized. more appropriate for self- on.anticoagulation.medications.such.as.warfarin..People.with.chronic.conditions. testing? (for.example,.congestive.heart.failure,.atrial.fibrillation,.prosthetic.heart.valve. replacement).who.will.need.frequent.monitoring.over.a.long.period.of.time.are. certainly.candidates.for.self-testing. What personal The.person.must.be.reliable,.compliance-oriented,.and.able.to.follow.instructions. characteristics must the potential user have? What do I look for Consider.the.following: in judging these •.

  • Page 12: Clinical.study

    User Selection Guidelines Once the potential user has Explain.to.the.person.in.general.terms.what.will.be.involved.and.provide.an. passed the initial screening, opportunity.to.ask.questions..If.he.or.she.expresses.interest,.send.a.copy.of. what do we do next? the.training.DVD.home.or.show.it.in.the.office..Stress.that.this.overview.is.only. intended.to.give.a.better.idea.of.what.self-testing.involves.and.that.more.detailed. training.and.follow-up.support.will.be.provided..Each.potential.user.will.be. instructed.on.the.fingerstick.procedure.and.perform.a.fingerstick.as.part.of.the. screening..If.the.person.wants.to.continue.participation.after.seeing.the.DVD.and. performing.a.fingerstick,.he.or.she.should.be.enrolled.in.a.training.class. Clinical Study Information A.clinical.study.was.conducted.by.Roche.Diagnostics.consisting.of.four.visits.to. the.clinical.site..Informed.consent.and.randomization.occurred.at.Visit.1..Testing. began.at.Visit.2..Ninety-one.individuals.completed.at.least.one.visit.after.Visit. 1..The.following.table.outlines.the.demographic.information.for.the.users.who. completed.at.least.one.visit.after.Visit.1. Demographic Number Percent Total.number.of.users 100% Caregivers 4.4% Males Females Age.range...

  • Page 13: Performance.characteristics

    User Selection Guidelines There.were.107.people.enrolled..A.total.of.88.people.completed.all.four.visits.to. the.site..The.reasons.for.drop-outs.were.as.follows: Reason for Drop-Out # of Subjects Felt.it.was.too.stressful Didn’t.have.time Didn’t.want.to.use.meter.on.his.own Didn’t.think.he.could.learn.to.use.meter Was.having.knee.surgery Study.terminated.prior.to.Visit.4 Unknown Disqualified.due.to.target.INR.range.outside.of.study.protocol PERFORMANCE ChARACTERISTICS Measuring Range: The.CoaguChek.XS.System.has.a.PT/INR.measuring.range.of.0.8–8.0.INR.and.. 9.6–96.0.seconds.. Accuracy: A.study.was.conducted.comparing.test.results.obtained.by.trained.users. with.those.obtained.by.healthcare.professionals,.when.both.were.using. the.CoaguChek.XS.System..The.correlation.was.very.good,.as.indicated.by. the.following.statistics:.N=463,.Slope=1.000,.Intercept=0.0.and.Correlation. Coefficient=0.977..This.study.shows.that.trained.users.are.able.to.obtain.results. that.are.as.accurate.as.those.obtained.by.healthcare.professionals.trained.in.the. use.of.the.CoaguChek.XS.System.
  • Page 14 User Selection Guidelines N = 297 PB: y = 1.154x - 0.2 Slp CI (1.111,1.198) Int CI (-0.3, -0.2) Correlation = 0.934 N = 463 PB: y = 1.000x + 0.0 Slp CI (1.000,1.030) Int CI (-0.05, 0) Correlation = 0.977...
  • Page 15 User Selection Guidelines Precision: A.study.was.conducted.and.the.precision.of.duplicates.for.capillary.blood.results. was.calculated.for.both.trained.users.and.healthcare.professionals..The.following. results.were.obtained: User Professional Results Results 249. Mean 2.57 2.52 0.13 0.13 5.13 5.36 This.study.shows.that.trained.users.are.able.to.obtain.results.that.are.as. precise.as.those.obtained.by.healthcare.professionals.trained.in.the.use.of.the. CoaguChek.XS.System.. During.the.study,.the.following.error.rates.were.observed: Visit 1 Visit 2 Visit 3 Overall Error.6 Test.Strip. 0.8% 0.9% 0.5% 0.7% Interference Error.5 Blood.Application 31.7% 23.9% 18.9% 25.2%...

  • Page 17: Training Users For Self-Testing

    However.the.training.is.scheduled,.it.is.important.to.allow.plenty.of.time.for. trainees.to.practice.the.testing.procedure.and.ask.questions. Training.is.mandatory..Users.should.not.be.permitted.to.take.a.meter.home. without.satisfactorily.completing.a.training.session.and.passing.the.Knowledge Test.and.Skills Checklist. Schedule.training.in.a.room.free.of.distractions.and.with.adequate.facilities.for. trainees.to.take.notes.and.practice.with.the.meters. Limit.training.classes.to.small.groups.so.trainees.can.have.individual.attention. during.the.practice.session..It.may.be.helpful.to.have.an.assistant. Organize.the.presentation,.gather.the.needed.supplies,.and.make.sure.the. meters.are.operational. SUPPlIES CoaguChek XS Testing •. . C oaguChek.XS.System.Care.Kit,.consisting.of: Supplies. •. CoaguChek.XS.Meter (one.set.for.each.trainee.. •. 4.AAA.batteries. plus.one.for.demonstration) •. CoaguChek.XS.System.User.Manual •. CoaguChek.XS.System.Getting.Started.Guide •. CoaguChek.XS.System.Prothrombin.Time.Self-Testing.Log.Book •. ACCU-CHEK .Softclix.lancet.device.and.lancets ® •. CoaguChek.XS.System.Training.DVD...

  • Page 18: Training.outline

    •. . B iohazard.waste.and.sharps.containers.for.disposal.of.supplies.and.lancets. used.during.practice •. . D isposable.gloves.for.instructor.and.assistants.to.wear.when.assisting.trainees. in.practicing.fingersticks •. . D VD.player •. . T V.monitor •. . S ufficient.copies.of.the.class.outline,.Knowledge Test,.Skills Checklist,.Log.Book,. Certificate of Completion,.and.key.sections.of.the.CoaguChek XS System User Manual,.especially.the.Error Messages section. TRAINING OUTlINE User Training Topic Time CoaguChek XS System Introduction.and.Overview.of.Training.Session.
  • Page 19 Test and Skills Checklist. 3.. . R eview.the.agenda.for.the.training.session..(This.outline.may.be.copied.and. distributed.to.attendees.as.a.detailed.reference.) Show.the.15-minute.Training.DVD,.which.gives.an.overview.of.the.testing. CoaguChek XS System Training DVD procedure,.built-in.quality.control.testing,.and.maintenance. 1.. . R eview.components.of.the.CoaguChek.XS.Meter Review of CoaguChek XS System and Operating •. Display.panel Guidelines •. M.(memory).button •. ON-OFF.button •. Test.strip.guide.cover •. Test.strip.guide. •. Battery.compartment.cover •.
  • Page 20 Training Users for Self-Testing 3.. . R eview.operating.conditions.of.the.meter.and.proper.storage.conditions.of.test. strips •. Operate.meter.at.room.temperature,.59˚. . to.90˚.F.(15˚. . to.32˚.C). •. Operate.meter.with.10%.to.85%.relative.humidity,.without.condensation. •. Avoid.bright.sunlight. •. Operate.the.meter.on.a.flat.surface,.free.of.vibrations. •. Use.the.provided.carrying.case. •. . R ead.the.information.packaged.with.the.test.strips.regarding.up.to. date.product.specifications.and.limitations. •. Read.the.latest.warfarin.package.insert.for.contraindications. Review System Set-Up 1.. . T he.CoaguChek.XS.System.uses.four.AAA.alkaline.batteries,.inserted.into. the.battery.compartment.on.the.back.of.the.meter..Explain.the.importance. of.entering.the.correct.date.and.time..(Each.time.you.run.a.test,.the.meter. compares.its.date.with.the.test.strip’s.expiration.date..If.the.test.strip.is.expired,. the.meter.displays.an.error.message.and.prevents.you.from.running.a.test.) 2..
  • Page 21 Training Users for Self-Testing 2.. . R eview.how.to.prepare.the.lancet.device... Users.pull.off.the.cap.and.insert.a.new.lancet..Provide.these.instructions:. Twist.off.the.lancet’s.protective.cap..Put.the.cap.back.on.the.lancet.device.. To.place.the.cap.back.on,.line.up.the.notch.on.the.cap.with.the.center.of. the.semi-circle..Turn.the.dial.so.that.the.center.of.the.semi-circle.points.to.5.. (The.lancet.device.has.multiple.depth.settings,.so.the.user.can.use.the.setting. that.works.best..The.higher.the.number,.the.deeper.the.penetration..The.first. time.a.person.uses.it,.try.a.depth.setting.of.5..If.the.blood.drop.you.get.is.not. sufficient,.try.a.higher.setting.). Instruct.the.user.to.press.the.plunger..A.yellow.dot.appears.in.the.release. button,.telling.the.user.that.the.device.is.ready..Tell.the.user.to.set.it.aside. while.preparing.for.the.fingerstick. 3.. . R eview.how.to.prepare.for.a.fingerstick,.instructing.the.user.to: •. Wash.the.hand.in.warm,.soapy.water..This.cleans.and.warms.the.hand. •. Massage.the.finger.from.its.base. •. Let.the.hand.hang.loosely.at.his.or.her.side.for.10.to.30.seconds. •. Use.these.techniques.until.the.fingertip.has.good.color. 4.. . R eview.testing.procedures,.instructing.the.user.to.follow.this.process: •. . T he.correct.code.chip.must.be.in.the.meter..The.code.chip. automatically.provides.the.meter.with.the.information.that.is.specific. to.each.lot.of.test.strips..Each.box.of.test.strips.comes.with.a.matching.
  • Page 22 Training Users for Self-Testing 5.. . R eview.collecting.and.applying.the.sample,.instructing.the.user.to.follow.. this.process: •. . M assage.the.finger.from.the.base.until.there.is.increased.color.in.the. fingertip..Keeping.the.hand.down,.press.the.tip.of.the.lancet.firmly. against.the.side.of.the.fingertip..Press.the.release.button. •. . T he.meter.must.be.on.a.table..Find.the.target.area.on.the.test.strip.. •. . W ithin 15 seconds of sticking the fingertip, apply the blood drop from the fingertip to the target area from the side..See.the.user. manual.for.more.information.
  • Page 23 When.the.quality.control.test.is.finished,.a.check.mark.(√).appears.following.the. letters.QC..Then.the.meter.continues.to.run.the.blood.test. The.built-in.quality.control.helps.you.know.that.your.test.strip.has.not.been. damaged..If.you.receive.a.test.error,.look.in.the.manual.for.an.explanation.of.. all.test.errors.. Cleaning/Disinfecting the Review.cleaning.procedures.with.the.user,.instructing.them.to.follow.the.process. detailed.in.the.following.text..Failure.to.follow.these.procedures.may.cause. CoaguChek XS System malfunction.of.the.meter. •... C lean.the.meter.only.when.contaminated.with.blood.. •... D o.not.use.sprays.of.any.sort.. •... E nsure.that.swab.or.cloth.is.only.damp,.not.wet.. Useful tip: to prevent contamination, apply blood via side-dosing directly from the fingertip. To.clean/disinfect.the.exterior.of.the.meter: •... U se.only.the.following.items.for.cleaning/disinfecting.the.CoaguChek.
  • Page 24 Training Users for Self-Testing 1... W ith.the.meter.turned.off,.wipe.the.meter’s.exterior.clean.. Apply.cleaning.agent.for.a.contact.time.of.>1.minute.(refer.to.the. corresponding.product.labeling). Do.not.let.liquid.accumulate.near.any.opening..Make.sure.that.no. liquid.enters.the.meter. 2... W ith.a.lint-free.tissue,.wipe.away.residual.moisture.and.fluids.after. cleaning.the.exterior.. Allow.wiped.areas.to.dry.for.at.least.10.minutes.before.performing.a.test. To.clean/disinfect.the.test.strip.guide: •... U se.only.70%.isopropyl.alcohol.or.10%.bleach.solution.to.clean.the.. CoaguChek.XS.test.strip.guide.. •... D o not use any other cleaning/disinfecting solutions on the test strip guide. Use of other cleaning/disinfecting solutions could result in damage to the meter..

  • Page 25: Testing.the.trainees

    Training Users for Self-Testing TESTING ThE TRAINEES 1.. . C omplete.the.Skills Checklist,.included.in.this.package,.after.observing.each. trainee.during.the.hands-on.practice.session..One.or.more.assistants.may.be. helpful.in.completing.the.checklists.without.slowing.down.the.class. 2.. . H ave.trainees.complete.the.Knowledge Test,.included.in.this.package,.at.the. end.of.the.training.presentation.and.practice.sessions. 3.. . S core.the.test.with.the.answer.key.and.review.any.areas.of.confusion. 4.. . D evelop.a.plan.before.the.training.class.for.remedial.action.if.trainees.do.not. perform.adequately.on.either.of.the.tests..In.some.cases,.it.may.be.necessary. to.return.the.trainee.to.a.laboratory.testing.regimen. The.Skills Checklist.and.Knowledge Test.master.forms.can.be.copied.as.needed. and.are.included.in.the.back.of.this.booklet. CERTIFICATE OF COMPlETION Each.trainee.who.successfully.completes.the.class.and.the.tests.should.be.given. a.certificate..A.certificate.that.can.be.copied.as.needed.is.included.in.the.Forms. section.at.the.back.of.this.booklet. FOllOW-UP VISITS Remind.all.trainees.they.are.required.to.return.for.two.follow-up.visits.where.they.

  • Page 27: Proficiency Checks

    •. . . D uring.the.interview,.record.your.observations.on.the.6-month. Performance.Evaluation.form. •. . . I nspect.the.meter.thoroughly. •. . . O bserve.the.user.cleaning.the.CoaguChek.XS.meter..If.necessary,. stress.the.importance.of.maintaining.a.regular.cleaning.schedule. •. . . O bserve.the.user.performing.a.blood.test..If.necessary,.offer. suggestions.for.improvement..A.2-week.follow-up.is.recommended. whenever.competency.needs.reassessment. •. . . T he.healthcare.professional.will.perform.a.user.blood.test.after.the. trainee.performs.a.self-test..The.test.should.match.within.30%;.this. verifies.that.the.meter.is.performing.properly..If.this.test.indicates.a. problem.with.the.meter.or.test.strips,.repeat.the.test..If.the.result.is.still.in. question,.please.contact.the.Roche.Diagnostics.Technical.Service.Center. 1-800-428-4674,.24.hours.a.day,.7.days.a.week,.365.days.a.year. •. . . I f.the.test.result.is.within.range.and.the.user.performs.all.tests. satisfactorily,.make.an.appointment.for.six.months.in.the.future.

  • Page 29: Forms

    Forms Follow-up for People Who Are Self-Testing OVERVIEW Introduction The.following.forms.are.included.as.part.of.the.CoaguChek.XS.System.training. for.self-testing. These.forms.should.be.used.as.originals..Please.feel.free.to.copy.them.as. needed. •. . . S kills Checklist •. . . K nowledge Test •. . . A nswer.Key •. Certificate of Completion...
  • Page 30 COAGUChEk XS SySTEM SkIllS ChECklIST Trainer.should.check.each.activity.as.it.is.demonstrated.or.described. Assembles Equipment o. . . C oaguChek.XS.meter o. . . C ontainer.of.test.strips. o. . . T est.strip.code.chip o. . . A CCU-CHEK.Softclix.lancet.device.and.lancet Reviews Procedure o. . . S tates.when.coding.is.needed o. . . T urns.meter.off.before.inserting.or.removing.code.chip o.
  • Page 31 COAGUChEk XS SySTEM SkIllS ChECklIST Recalls Results from o. . C orrectly.recalls.results.stored.in.memory Memory Problem Solving o. . R efers.to.Error Messages.in.the.user.manual.when.a.problem.occurs Cleaning o. . S tates.minimum.cleaning.frequency o. . D emonstrates.exterior.cleaning.procedure.as.stated.in.the.user.manual o. . P roperly.cleans.test.strip.guide Battery Replacement o. . D emonstrates.removal.and.replacement.of.batteries Trainee.Name:.._____________________________________________________ Training.Date:.._____________________________________________________...
  • Page 32 COAGUChEk XS SySTEM kNOWlEDGE TEST Mark “T” if the statement is true and “F” if the statement is false. _____. 1 .. . W hen.coding.the.CoaguChek.XS.Meter,.you.must.use.the.code.chip. from.the.same.test.strip.container.that.you.are.using. _____. 2 .. . A fter.removing.a.test.strip.from.the.container,.it.is.important.to.close.the. cap.tightly. _____. 3 .. . W hen.performing.a.blood.test,.it.is.important.to.hold.the.finger.to.the. strip.until.the.meter.beeps.
  • Page 33 13.. What.would.cause.Error.5.to.appear.on.the.display? .______________________________________________________________ .______________________________________________________________ .______________________________________________________________ .______________________________________________________________ 14.. . A fter.inserting.a.test.strip,.the.code.flashes.on.the.display..What.is.the.next.step? .______________________________________________________________ .______________________________________________________________ .______________________________________________________________ .______________________________________________________________ 15.. . W hy.is.it.important.to.apply.blood.to.the.test.strip.within.15.seconds.. of.sticking.the.finger? .______________________________________________________________ .______________________________________________________________ .______________________________________________________________ .______________________________________________________________ Trainee.Name:.._____________________________________________________ Training.Date:.._____________________________________________________ COAGUCHEK,.ACCU-CHEK.and.SOFTCLIX. Training.Site:..______________________________________________________ are.trademarks.of.Roche. Trainer.Name:.._____________________________________________________ All.other.trademarks.are.property.of.their. respective.owner. Trainer.Signature:.. _ _______________________________ .Date:.. _ ____________ ©2007–2015.Roche.Diagnostics... All.rights.reserved.. 04999096003-0515...
  • Page 34 ANSWER kEy For CoaguChek XS System knowledge Test . 1 ... T . 2 ... T . 3 ... T . 4 ... F .–.The.sample.must.be.applied.to.the.test.strip.within.10.minutes.of.removing. the.strip.from.the.container. . 5 ... T . . 6 ... T . 7 ... F .–.If.the.built-in.quality.control.does.not.pass,.a.flashing.“QC”.will.appear.on.
  • Page 35 CoaguChek ® System Certificate of Completion presented to for successfully completing Self-Testing training on the CoaguChek XS System ® Dated:_________________________________ Certified Training Consultant COAGUCHEK,.ACCU-CHEK.and.SOFTCLIX.are. trademarks.of.Roche. All.other.trademarks.are.property.of.their. respective.owner. ©2007–2015.Roche.Diagnostics... All.rights.reserved.. 04999096003-0515...
  • Page 36 ACCU-CHEK,.COAGUCHEK.and.SOFTCLIX.. are.trademarks.of.Roche. Manufactured.for.and.distributed.in.the.U.S.A..by:.. Roche.Diagnostics.. 9115.Hague.Road.. Indianapolis,.IN.46256 . Roche.Diagnostics.GmbH.. Sandhofer.Strasse.116.. 68305.Mannheim.. Germany www.coaguchek-usa.com...

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