Invivo ESSENTIAL MRI PATIENT MONITOR User Manual 989803173791

Invivo Corporation MRI PATIENT MONITOR 989803173791

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ESSENTIAL User Manual

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*989803173791*

989803173791

Essential MRI Patient Monitor

(Model 865353)

Instructions for Use

989803173791 Rev 0.6

English

2 989803173791 Rev 0.6

989803173791 Rev 0.6 3

Manufacturer

InvivoCorporation

Orlando,Florida32826

U.S.A.

(407)275‐3220

(800)331‐3220

www.invivocorp.com

REF989803173791Rev.A,October2010

Equipment Classification

NOTE

LawsintheUnitedStatesrestrictthisdevicetosalebyorontheorderofaphysician.

EQUIPMENTCLASSIFICATION(accordingtoIEC60601‐1)

Accordingtothetypeofprotection

againstelectricalshock ClassIequipment

Accordingtothedegreeofprotection

againstelectricalshock: TypeCF(defibrillator‐proof)equipment

Accordingtothedegreeofprotection

againstharmfulingressofwater:

IPX2(enclosedequipmenttilted15degrees

withprotectionagainstdrippingliquid).

Accordingtothemethodsofsterilization

ordisinfection:

Non‐sterilizable.Useofliquidsurface

disinfectantsonly.

Accordingtothemodeofoperation: Continuousoperation

Equipmentnotsuitableforuseinthepresenceofflammableanestheticmixturewithair

orwithoxygenornitrousoxide.

4 989803173791 Rev 0.6

Proprietary Information

Thisdocumentandtheinformationcontainedinitisproprietaryandconfidentialinformationof

Invivoandmaynotbereproduced,copiedinwholeorinpart,adapted,modified,disclosedto

others,ordisseminatedwithoutthepriorwrittenpermissionofInvivo.Thisdocumentis

intendedtobeusedbycustomersandislicensedtothemaspartoftheirInvivoequipment

purchase.Useofthisdocumentbyunauthorizedpersonsisstrictlyprohibited.

Invivoprovidesthisdocumentwithoutwarrantyofanykind,impliedorexpressed,including,but

notlimitedto,theimpliedwarrantiesofmerchantabilityandfitnessforaparticularpurpose.

Invivohastakencaretoensuretheaccuracyofthisdocument.However,Invivoassumesno

liabilityforerrorsoromissionsandreservestherighttomakechangeswithoutfurthernoticeto

anyproductshereintoimprovereliability,function,ordesign.Invivomaymakeimprovementsor

changesintheproductsorprogramsdescribedinthisdocumentatanytime.

Neweditionsofthisdocumentwillincorporateallmaterialupdatedsincethepreviousedition.

Updatepackagesmaybeissuedbetweeneditionsandcontainreplacementandadditionalpages.

Notethatpageswhicharerearrangedduetochangesonapreviouspagearenotconsidered

revised.

Thedocumentationpartnumberandrevisionindicatethecurrentedition.Theprintingdate

changeswhenanewrevisionisprinted.(Minorcorrectionsandupdateswhichareincorporated

atreprintdonotcausethedatetochange.)Thedocumentrevisionletterchangeswhen

extensivetechnicalchangesareincorporated.

Contents

989803173791 Rev 0.6Contentsi

Chapter 1: Important Information

Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

System Conventions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Document Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Cautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Power. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Miscellaneous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Electromagnetic Compatibility (EMC). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Radios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

EMC Emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

EMC Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Recommended Separation Distances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Battery Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Disposing of Batteries in Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Disposing of Batteries in the United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

List of Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Unpacking the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Examining the Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Carry Case. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Mount Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Roll Stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Chapter 2: Getting Started

System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Battery Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Using Batteries Safely . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Main Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Module Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Charging Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Monitor Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Wireless SpO2 Module Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Assigning the Module Network. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Changing the Module Network Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Initial System Power-Up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Display Panel Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Chapter 3: Preparation for Use

Using the Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

System Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

iiContents 989803173791 Rev 0.6

Navigating the Menu Groups and Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Controlling Menu Changes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Locking and Unlocking the Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Patient Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Setup Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Service Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Network Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Alarm Limits Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Sound Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Chapter 4: Monitoring SpO2

SpO2 Sensor and Wireless SpO2 Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Connecting the Sensor and Attachments to the WSpO2 Module. . . . . . . . . . . . . . . . . . . . . . . 52

Patient Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Applying and Positioning the SpO2 Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Positioning the WSpO2 Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Measuring SpO2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Waveform and Vital Sign Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

No Data Available Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Assessing Suspicious SpO2 Readings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Perfusion Index Value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Managing Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Alarm Types, Priorities and Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Physiological Alarm Violations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Technical Alarm Violations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Alarm Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

System Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Chapter 5: Workflow

Workflow Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Chapter 6: Maintenance and Repair

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

Cleaning the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

Cleaning the Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Appendix A: Specifications

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Dimensions and Weights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .78

Display (LCD) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

Displayed Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

989803173791 Rev 0.6Contentsiii

Pulse Oximeter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Power Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Appendix B: Warranty

Warranty Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

Appendix C: Regulatory Information

European Union . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

Declaration of Conformity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

Authorized Representative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

Appendix D: Guidelines and References

Guidelines for the Prevention of Excessive Heating And Burns Associated with Magnetic Reso-

nance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85

References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Notes

ivContents 989803173791 Rev 0.6

989803173791 Rev 0.6Chapter1:ImportantInformation1

Chapter 1: Important Information

Informationregardingthesafety,accessories,installation,andoperationofafullyequipped

EssentialMRIPatientMonitor(Model865353)isincludedinthismanual.Foradditional

informationaboutyouraccessories,pleaseconsultthedocumentationthataccompaniesthe

accessory.

Thisproductwillperforminconformitywiththedescriptioncontainedinthismanualand

accompanyinglabelingwhenassembled,operated,maintained,andrepairedinaccordancewith

theinstructionsprovided.

Thisdevicemustbecheckedperiodically.Amalfunctioningdevicemustnotbeused.Partsthat

arebroken,missing,plainlyworn,distorted,orcontaminatedmustbereplacedimmediately.

Referthedevicetoqualifiedservicepersonnelforrepairorreplacement.Thisdeviceoranyofits

partsmustnotberepairedotherthaninaccordancewithwritteninstructionsprovidedbythe

manufacturer.ThedeviceshallnotbealteredwithoutwrittenapprovalofInvivo.Theuserhas

thesoleresponsibilityforanymalfunctionwhichresultsfromimproperuse,faultymaintenance,

improperrepair,damageoralterationbyanyoneotherthanInvivoorInvivo‐authorizedservice

personnel.

Intended Audience

TheEssentialMRIPatientMonitor(Model865353)isintendedforusebyhealthcare

professionalstrainedintheuseoftheequipmentandvitalsignsmonitoring.

Warnings

BeforeusingtheEssentialMRIPatientMonitor(Model865353),readthewarningshereand

thoseintheSafetysectionbelow.ThewarningsandnotesbelowrefertotheEssentialMRI

PatientMonitor(Model865353)initsentirety.

WARNINGS

• ThoroughlyreadandunderstandtheseInstructionsforUsepriortouse.

•Shockhazardexistsifthesystemisoperatedwithoutcovers.

•UseonlysuppliedpowercordsandconnectonlytoproperlygroundedACoutletsto

avoidelectricalshock.

2Chapter1:ImportantInformation 989803173791 Rev 0.6

WARNINGS

•Patientmotionorpositionoftheaccessoriesmayaffectmeasurementaccuracy.Always

consultaphysicianforinterpretationofmeasurementsprovidedbythesystem.

•Performoperationalverificationpriortouse.Ifthesystemfailstofunctionproperly,

removeitfromuseandcontactInvivoTechnicalSupportpersonnel.

• Screenallpatientsformetallicwires,implants,stents,etc.priortoMRprocedures.These

electricalconductorswillreactwiththeMRenvironmentorwiththeInvivoaccessory(if

applieddirectlyovertheconductor),thusincreasingtheriskofheating.

NOTE

TheEssentialMRIPatientMonitor(Model865353)isnotintendedforuseonapatientbeing

transportedoutsideahealthcarefacility.

Conventions

TheEssentialMRIPatientMonitor(Model865353)usescertainconventionsthroughoutthe

interfacetomakeiteasyforyoutolearnanduse.Thisaccompanyinguserinformationalsouses

documentconventionstoassistyouinfindingandunderstandinginformation.

System Conventions

Theseconventionsareusedinthesystem:

•Operationalcontrolisaccomplishedthroughthedisplaypanel.

•Whencontrolormenuitemsareprovidedonthedisplaypanel,touchingthatcontrolor

itemwillactivateoropenit.

•Toprotectagainstaccidentalchangesofirreplaceabledata,aconfirm/cancelpromptis

associatedwithcertainmenuoptions.Whenapromptisdisplayed,youmustconfirmor

cancelthisaction;otherwise,adelayofapproximately30secondswithoutselectionwillbe

equivalenttoselectingcancel.

Document Conventions

•Allproceduresarenumbered,whileanysub‐proceduresarelettered.Completethesteps

inthesequencepresentedtoensuresuccess.Proceduresareindicatedbythefollowing

table:

989803173791 Rev 0.6Chapter1:ImportantInformation3

•Bulletedlistsindicategeneralinformationaboutaparticularfunctionorprocedure,anddo

notimplyasequentialprocedure.

•Messagesregardingaconditioninthedevicearegivenwithinquotationmarks(“”)spelled

andpunctuatedastheyappearinthesystem,unlessincludedasinformationinatable.

•Controlnames,buttonsandmenuitemsortitlesarespelledandpunctuatedasthey

appearinthesystem.

•Symbolsappearastheyappearonthesystem.

•Selectmeanstotouchortaplightlywithafinger(orstylus)withintheboundariesofa

controlitemonthedisplaypanel.

•Theleftsideofthesystemisonyourleftasyoustandinfrontofthesystem,facingit.The

frontofthesystemisnearestyouasyouoperateit.

•Thefrontofthemoduleisnearestyouasyouoperateit.

Warnings

Warning

WAR NIN G

Warningsprovideinformationyoushouldknowtoavoidinjuringyourself,patientsor

personnel.

Cautions

CAUTION

Cautionsprovideinformationyoushouldknowtoavoiddamagingtheequipmentandsoftware.

Notes

NOTE

Notesprovideadditionalinformationregardingsystemusage.

Step Action

4Chapter1:ImportantInformation 989803173791 Rev 0.6

Accessories

Availableaccessoriesarelistedinthetablesbelow.OnlyuserecommendedInvivopatient

sensors,grips,etc,asotherbrandsmaycompromisethesafetyandaccuracyofthesystem.

SpO2

Power

Description PartNumber

QuickConnectSpO2Clip,Adult 989803166531

QuickConnectSpO2Clip,Pediatric 989803166541

QuickConnectSpO2Grip,Adult,20/box 989803166551

QuickConnectSpO2Grip,Infant,20/box 989803166571

QuickConnectSpO2Grip,Neonatal,20/box 989803166581

QuickConnectSpO2Grip,Pediatric,20/box 989803166561

QuickConnectSpO2Grip,StarterPack 989803167111

QuickConnectSpO2Sensor,MRI 989803161991

WirelessSpO2Module(Expression) 989803163111

WirelessSpO2Module(Precess‐Blueversion) 989803172431

Description PartNumber

MainBattery989803171671

ModuleBattery9065

PowerAdapter 989803171691

PowerCord,Brazil250V989803173901

PowerCord,European220‐230V453564177501

PowerCord,UnitedKingdom220‐240V989803174171

PowerCord,US110V989803168211

PowerCord,Universal220V AS18A

989803173791 Rev 0.6Chapter1:ImportantInformation5

Miscellaneous

Description PartNumber

CarryCase989803171711

MountAdapter 989803171681

RollStand 989803173761

UniversalHolderPoleKit(forusewithRollStand) 989803174281

InformationforUseManual,Chinese,Simplified989803174041

InformationforUseManual,Chinese,Traditional989803174081

InformationforUseManual,Czech989803173911

InformationforUseManual,Dutch989803173921

InformationforUseManual,English989803173791

InformationforUseManual,Finnish 989803173931

InformationforUseManual,French989803173941

InformationforUseManual,German989803173951

InformationforUseManual,Greek 989803173961

InformationforUseManual,Hungarian989803173971

InformationforUseManual,Italian 989803173981

InformationforUseManual,Japanese 989803173991

InformationforUseManual,Norwegian 989803174001

InformationforUseManual,Polish 989803174011

InformationforUseManual,Portuguese 989803174021

InformationforUseManual,Russian 989803174031

InformationforUseManual,Slovak 989803174051

InformationforUseManual,Spanish 989803174061

InformationforUseManual,Swedish 989803174071

InformationforUseManual,Turkish 989803174091

ServiceManual 989803173771

6Chapter1:ImportantInformation 989803173791 Rev 0.6

Safety

Electromagnetic Compatibility (EMC)

Thesystemisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Giventhe

system’selectromagneticemissionsandimmunitycharacteristics,thecustomerortheuser

shouldassurethatthesystemisusedwithinsuchanenvironment.

Radios

FrequencyRange:2402to2482MHz.

ModulationType:GMSK.

MonitorEIRP:4.2dBm(peak).

WSpO2EIRP:0dBm(peak)

EMC WA R NINGS EMC WA R NINGS

•OperationofthesystemoutsidethespecificationsindicatedinAppendixAmaycause

inaccurateresults.

•Theuseofportableandmobileradio‐frequency(RF)communicationsequipmentcan

affecttheoperationofthisdevice.

•TheuseofaccessoriesandcomponentsotherthanthosespecifiedintheAccessorieslist

accompanyingtheseinstructionsforuse(withtheexceptionofitemssoldbyInvivofor

theequipmentorsystemasreplacementpartsforinternalcomponents)willresultin

increasedemissionsordecreasedimmunityoftheequipmentorsystem.

•Thesystemshouldnotbeusedadjacenttoorstackedwithotherequipment(except

otherInvivoequipment,asdetailedinthisdocument)andthatifadjacentorstackeduse

isnecessary,theequipmentorsystemmustbeobservedtoverifynormaloperationin

theconfigurationinwhichitwillbeused.

•ThesystemneedstobeinstalledandputintoserviceaccordingtotheEMCinformation

providedbelow.PortableandmobileRFcommunicationsequipmentcanaffectmedical

electricalequipment.ThesystemmaybeinterferedwithbyotherequipmentwithCISPR

emissionrequirements.

989803173791 Rev 0.6Chapter1:ImportantInformation7

EMC Emissions

Electromagneticemissionsistheabilityofaproduct,adevice,orasystemtointroduce

intolerableelectromagneticdisturbancesintotheuseenvironment.

GuidanceandManufacturer’sDeclaration–

ElectromagneticEmissions

EmissionsTest Compliance ElectromagneticEnvironment‐Guidance

TheEssentialMRIPatientMonitor(Model865353)isintendedforuseintheelectromagneticenvironment

specifiedbelow.ThecustomerortheuseroftheEssentialMRIPatientMonitor(Model865353)shouldassure

thatitisusedinsuchanenvironment.

RFEmissions

CISPR11 Group1

ThesystemusesRFenergyonlyforitsinternalfunctions.

Therefore,itsRFemissionsareverylowandarenot

likelytocauseanyinterferenceinnearbyelectronic

equipment.

RFEmissions

CISPR11 ClassA

Thesystemissuitableforuseinallestablishments,other

thandomesticestablishmentsandthosedirectly

connectedtothepubliclow‐voltagepowersupply

networkthatsuppliesbuildingsusedfordomestic

purposes.

HarmonicEmissions

IEC61000‐3‐2ClassA

VoltageFluctuations/flicker

emissions

IEC61000‐3‐3

Complies

8Chapter1:ImportantInformation 989803173791 Rev 0.6

EMC Immunity

Electromagneticimmunityistheabilityofaproduct,adevice,orasystemtofunction

satisfactorilyinthepresenceofelectromagneticinterference.

GuidanceandManufacturer’sDeclaration‐ElectromagneticImmunity

ImmunityTest IEC60601

TestLevel

Compliance

Level ElectromagneticEnvironment‐Guidance

TheEssentialMRIPatientMonitor(Model865353)isintendedforuseintheelectromagneticenvironment

specifiedbelow.ThecustomerortheuseroftheEssentialMRIPatientMonitor(Model865353)shouldassure

thatitisusedinsuchanenvironment.

ConductedRF

IEC61000‐4‐6

RadiatedRF

IEC61000‐4‐3

3Vrms

150KHzto80MHz

3V/m

80MHzto2.5GHz

V1=3Vrms

E1=3V/m

PortableandmobileRFcommunications

equipmentshouldnotbeusedclosertoanypart

ofthesystem(includingcabling)thanthe

recommendedseparationdistance,ascalculated

bytheequationapplicabletothefrequencyof

thetransmitter.Recommendedseparation

distance:

d=(3.5/V1)

d=(3.5/E1)

(80MHzto800MHz)

d=(7/E1)

(800MHzto2.5GHz)

WherePisthemaximumtransmitteroutput

powerratinginwatts(W),accordingtoitsmanu‐

facturer,anddistherecommendedseparation

distanceinmeters(m).

FieldstrengthsfromfixedRFtransmitters,as

determinedbyanelectromagneticsitesurvey,a

shouldbelessthanthecompliancelevelineach

frequencyrange.b

Interferencemayoccurinthevicinity

ofequipmentmarkedwiththis

symbol:

NOTES

•At80MHzand800MHz,thehigherfrequencyrangeapplies.

•Theseguidelinesmaynotapplyinallsituations,aselectromagneticpropagationisaffectedbyabsorption

andreflectionfromstructures,objectsandpeople.

aFieldstrengthsfromfixedtransmitters,suchasbasestationsforradio(cellular/cordless)telephonesandland

mobileradios,amateurradio,AMandFMradio,andTVbroadcastscannotbepredictedtheoreticallywith

accuracy.ToassesstheelectromagneticenvironmentduetofixedRFtransmitters,anelectromagneticsite

surveyshouldbeconsidered.IfthemeasuredfieldstrengthinthesystemlocationexceedstheapplicableRF

compliancelevelabove,thesystemshouldbeobservedtoverifynormaloperation.Ifabnormaloperationis

observed,additionalmeasuresmaybenecessary,suchasreorientingorrelocatingthesystem.

bOverthefrequencyrange150KHzto80MHz,fieldstrengthsshouldbelessthan3V/m.

989803173791 Rev 0.6Chapter1:ImportantInformation9

Recommended Separation Distances

ThesystemisintendedforuseinanelectromagneticenvironmentwhereradiatedRF

disturbancesarecontrolled.Thecustomeroruserofthesystemcanhelpprevent

electromagneticinterferencebymaintainingaminimumdistancebetweenportableandmobile

RFcommunicationsequipment(transmitters)andthesystemasrecommendedbelow,according

tothemaximumoutputpowerofthecommunicationsequipment.

RecommendedSeparationDistancesbetweenPortableandMobileRFCommunicationsEquipment

andtheSystem

RatedMaximum

OutputPowerof

Transmitter

(W)

SeparationDistanceAccordingtoFrequencyofTransmitter(m)

150KHzto80MHz

d=(3.5/V1)

80MHzto800MHz

d=(3.5/E1)

800MHzto2.5GHz

d=(7/E1)

TheEssentialMRIPatientMonitor(Model865353)isintendedforuseintheelectromagneticenvironment

specifiedbelow.ThecustomerortheuseroftheEssentialMRIPatientMonitor(Model865353)shouldassure

thatitisusedinsuchanenvironment.

0.01 0.117 0.117 0.233

0.1 0.369 0.369 0.738

1 1.167 1.167 2.333

10 3.689 3.689 7.379

100 11.667 11.667 23.333

Fortransmittersratedataminimumoutputpowernotlistedabove,therecommendedseparationdistance(d)

inmeters(m)canbeestimatedusingtheequationapplicabletothefrequencyofthetransmitter,wherePisthe

maximumoutputpowerratingofthetransmitterinwatts(W)accordingtoitsmanufacturer.

NOTES

•At80MHzand800MHz,thehigherfrequencyrangeapplies.

•Theseguidelinesmaynotapplyinallsituations,aselectromagneticpropagationisaffectedbyabsorption

andreflectionfromstructures,objectsandpeople.

10Chapter1:ImportantInformation 989803173791 Rev 0.6

Battery Disposal

Thesystemuseslithiumbatteriesthataresubjecttostrictdisposalregulationsforuserand

environmentalsafety.

Caution

CAUTIONS

•Storebatteriesinadryplace,between0°Cto40°C.

• Neverheatorthrowabatteryintofire.Heatingthebatterywilldamagethesafety

circuitry,whichcancauseruptureorignitionofthebattery.

• Neverdisassemblethebattery.Thebatteriescontainhazardousmaterialthatmustbe

recycledordisposedofproperly.(Refertothedisposalguidelinesbelow.)

Disposing of Batteries in Europe

TheEuropeanCommunity(EC)hasissuedtwodirectivesregardingbatterydisposal:91/157/EEC

and93/86/EEC.Eachmembercountryimplementstheseindependently.Thus,ineachcountry

themanufacturers,importers,andusersareresponsiblefortheproperdisposalorrecyclingof

batteries.Confirmproperdisposalrequirementswithyourhealthcarefacilityordistributor.

Disposing of Batteries in the United States

LithiumbatteriesareneitherspecificallylistednorexemptedfromtheFederalEnvironmental

ProtectionAgency(EPA)hazardouswasteregulations,asconveyedbytheResources

ConservationandRecoveryAct(RCRA).Theonlymetalofpossibleconcerninthebatteryisthe

lithiummetal,whichisnotlistedorcharacterizedasatoxichazardouswaste.Asignificant

amountofspentcellsandbatteriesthatareuntreatedandnotfullydischargedareconsideredas

reactivehazardouswaste.Thus,hazardouswasteofspentcellsandbatteriescanbedisposed

aftertheyarefirstneutralizedthroughanapprovedsecondarytreatmentpriortodisposal(as

requiredbyU.S.LandBanRestrictionoftheHazardousandSolidWasteAmendmentsof1984).

Disposalofspentbatteriesmustbeperformedbyanauthorized,professionaldisposalcompany,

whichhastheknowledgeintherequirementsoftheFederal,theStateandtheLocalauthorities

regardinghazardousmaterials,transportation,andwastedisposal.Confirmproperdisposal

requirementswithyourhealthcarefacility,distributor,and/orlocalEPAoffice.

989803173791 Rev 0.6Chapter1:ImportantInformation11

List of Symbols

Thefollowingsymbolsareusedonthesystem,packingmaterials,andinthisdocument:

Attention,consult

accompanyingdocuments

MRConditional:Useinthe

MRenvironmentisrestricted

tocertainconditionsofuseto

ensurepatientandoperator

safety.

Non‐ionizingradiationNotMRsafe

Poweron/offPercentoxygenpulse

saturation

Productpartnumber Earthground

Alternatingcurrent Antenna

Directcurrent Deviceconformstothe

MedicalDeviceDirective

Productserialnumber WarningShockHazard

Warning/Caution

Dateofmanufacture

YYYY‐MM

12Chapter1:ImportantInformation 989803173791 Rev 0.6

Defibrillator‐ProoftypeCF

equipment(IEC60601‐1)

protectionagainstshock

Attention:Electrostaticsafety

device,observeprecautions

Potentialrestrictionsfor

equipmentincludingradios

mayapplywithinoneormore

European(EU)member

states.

Dangerousvoltage

TypeCFappliedpart Patient

MainbatterygaugeModulebatterygauge

NoBatteryCommunications No(Module)Communications

EnergyStarratedproduct GreenSealproduct

Donotadjustwithout

referringtoservicemanual

Radionetwork(wireless

modules)

NetworkANetwork1

NetworkBNetwork2

989803173791 Rev 0.6Chapter1:ImportantInformation13

NetworkCNetwork3

NetworkDNetwork4

NetworkENetwork5

Deviceconformstothe

R&TTEDirective(Radio&

TelecommunicationsTermina l

Equipment)

CanadianStandards

Association(CSA)SafetyMark

fortheUnitedStatesand

Canada

FederalCommunications

Commission

Disposeofthebatteryin

accordancewithyour

country’srequirements

Disposeofelectrical

equipmentinaccordance

withyourcountry’s

requirements

Indoor,drylocationuseonly

Deviceconformstothe

ElectricalApplianceand

MaterialsLawofJapan

Externalpowersupply

internationalefficiencymark,

level4

UnderwritersLaboratories

RecognizedComponent

Mark,complianceinCanada

andU.S.A.

14Chapter1:ImportantInformation 989803173791 Rev 0.6

Unpacking the System

Removethecontentsfromtheshippingcontainer(s).Carefullyexamineallitemsforsignsof

damagethatmayhaveoccurredduringshipment.Also,checkallitemsagainstthepackinglist

andthepurchaserequest.

Toreportshippingdamageortoresolveanyissuesorconcernswithyourorder,contactInvivo

CustomerService.(Saveallpackingmaterialsandrelatedshippingdocuments,asthesewillbe

requiredtoprocessadamageclaimwiththecarrier.)

CAUTION

TheEssentialMRIPatientMonitor(Model865353)mustbeusedandstoredaccordingtothe

environmentalspecificationsinAppendixA.Failuretofollowthesespecificationsmayaffect

systemaccuracy.

Examining the Contents

Thesystemincludestheseitems:

•Monitorandbattery

•Poweradapter(notMRsafe)

•Powercord

•IFUmanual

• WirelessSpO2module,batteryandaccessories(optional)

Accessories

Optionalaccessoriesareavailabletoprotect,carryandmountthesystem.

CAUTION

Whenusingtheaccessoriesmakesurethattheviewofthedisplaypanelisnotobstructed.

Carry Case

Thecarrycase(REF989803171711)offersconvenientprotectedstorageforthemonitor,even

duringoperation.Alargeclearwindowallowsvisualandoperationalaccesstothedisplaypanel,

whilesideandrearpocketsofferstorageformodulesandaccessories.

989803173791 Rev 0.6Chapter1:ImportantInformation15

Caution

CAUTIONS

•Donotplacemagneticitemsinsidethecarrycase,astheycouldbeinadvertentlybrought

intotheMRIsystemroom.

•Ensurethatthealarmtoneisaudiblewhenoperatingthemonitorusingthecarrycase.

•Usecautionwhenoperatingthemonitorusingthecarrycase,asthealarmlightwillnotbe

visible.

Mount Adapter

Themountadapter(REF989803171681)isasecuresolutionwhenattachingthemonitortoa

poleorrail.

1Pins

2Thumbscrew

3Clamp

4Knob

16Chapter1:ImportantInformation 989803173791 Rev 0.6

Toinstallthemonitorontothemountadapter,followthestepsbelow:

Roll Stand

Therollstand(REF989803173761)offersawheeledmobilitysolution

whentransportingthemonitor(mountadapteroptionalsorequired).

And,forconvenientstorageofthemoduleandaccessories,theUniversal

HolderPoleKit(REF989803174281)isavailable.

Step Action

1Alignthepins(Item1)ofthemountadaptertothelocatorholesin

thebaseofthemonitor.

2InserttheThumbscrew(Item2)intothebaseofthemonitorthen

tightentosecurethemonitortothemount.

3Withthemonitorinthedesiredlocation,placetheclamp(Item3)

aroundapoleorrailthensecurelytightentheknob(Item4).

4Ifneeded,pivotthemounthorizontallyorverticallytoorientthe

monitorforviewing.

5Ifneeded,loosentheknob(Item4)slightlytoreadjustthemonitor

fortheoptimumviewinganglethenretightentheknob.This

completestheprocedure.

989803173791 Rev 0.6Chapter2:GettingStarted 17

Chapter 2: Getting Started

TheEssentialMRIPatientMonitor(Model865353)isintendedforusebyhealthcareprofessionals

monitoringpulseoximetryandpulserateinanMRIsystemroomandincloseproximitytothe

scannermagnet.Additionally,thismonitoringisprovidedbefore,duringandafteractivescanning

intheMRIenvironment.

Thesystemcombineswirelesscommunications,radiofrequencyshielding,digitalsignal

processingandadaptablemountingtechnologiestoprovideaccurate,continuousandreliable

patientmonitoringperformanceinthedynamicMRIenvironment.

TheEssentialMRIPatientMonitor(Model865353)canbeconfigured,accessedandadjustedfor

theuniquevitalneeds,conditionsandsituationsofawidespectrumofpatientsfromneonateto

adult,specifically:

•Criticallyillpatients

• Interventionprocedures

•Intraoperativeprocedures

•PatienttransportwithintheMRenvironment

NOTE

Thesystemissuitableforuseinthepresenceofelectrosurgery.

System Components

ThecomponentsthatcompriseaworkingEssentialMRI

PatientMonitor(Model865353)systemincludethe

monitorandaWSpO2modulewithattachments.

CAUTION

Tominimizethechanceofimageartifacts,noneofthemonitoringcomponentsshouldbeplaced

withintheMRIFieldofView.

18Chapter2:GettingStarted989803173791 Rev 0.6

Battery Operation

TheEssentialMRIPatientMonitor(Model865353)operatesfromrechargeablebatteriesthat

provideapproximately8hoursofcontinuouspower.Visualindicationsofthechargedcapacityof

thebatteriesisconstantlyreported,whilealarmsprovidealertswhenlowpowerconditionsare

detected.

Using Batteries Safely

Thebatteriesinthissystemarenon‐magneticandcanbehandledsafelyintheMRsystemroom.

WAR NIN G

DonotuseortakethepoweradapterinsidetheMRsystemroom.Thedeviceismagneticand

willbepulledintotheMRsystem.Thedeviceisintendedforusewiththemainbatteryandthe

modulebatteryonlywhenoutsidetheMRsystemroom.

Batterieshavelifecycles.Whentheequipmentoperatingtimeprovidedbybatterypower

becomesmuchshorterthanusual,thebatterylifeisatanend.Immediatelyremoveabattery

thathasanexpiredlifecycleandreplaceitwithanewInvivospecifiedbattery;refertoBattery

DisposalinChapter1whendiscardingabattery.Toensurethesafetyofoperatorsandpatients,

observethefollowingwarningsandcautions.

WAR NIN G

Stopusinganybatterythatexhibitsabnormalheat,odor,color,deformation,orother

condition.Ifabatteryispuncturedorifbatteryliquidleaksontoyourskinorclothing,

immediatelywashtheareaandclothingwithfreshwater.Ifbatteryliquidgetsintoyoureyes,

donotrubyoureyes;immediatelyflushyoureyeswithcleanwaterandconsultaphysician.

CAUTIONS

•Ifthebatterycontactsbecomedirty,wipethemcleanwithadryclothbeforeuse.

• Keepmetalobjectsawayfromthebatterycontacts.

Main Battery

Themainbatteryfitsthecontourofthemonitorandlatchesintothebatterycompartment.

CAUTION

Neverforcethebatteryintothebatterycompartmentasdamagetothebatteryand/orthe

monitorcouldoccur.

989803173791 Rev 0.6Chapter2:GettingStarted 19

Installing the main battery

Toinstallthemainbatteryfollowthesesteps:

Step Action

1PlacethecoverovertheDCinletonthemainbattery.

2Lowerthemainbatteryintothebatterycompartmentthenpivotit

intoplace,asshownbelow.

3Slidethelockingtabtotheleftuntillatched.

Cover

DC inlet

Battery compartment

Locking tab

20Chapter2:GettingStarted989803173791 Rev 0.6

Removing the main battery

Toremovethemainbatteryfollowthesesteps:

Module Battery

Themodulebatterylatchesintothewirelessmodule.

Installing the module battery

Toinstallthemodulebattery,slidethebatteryinbetweentheslotsonthemoduleuntilboth

lockingtabslatch.

Step Action

1Slidethelockingtabonthemainbatterytotheright.

2Liftthemainbatteryoutofthebatterycompartment.

Locking tab Main battery

Battery compartment

Slot

Locking tab

Module battery

989803173791 Rev 0.6Chapter2:GettingStarted 21

Removing the module battery

Toremovethemodulebattery,pressbothlockingtabsandthenslidethebatteryoutofthe

module.

Charging Batteries

Theintelligentcharger,anintegralpartofthemainbatteryassembly,simultaneouslychargesthe

mainandmodulebatteries,whiletheexternalpoweradaptersuppliestheappropriateDCinput.

NOTE

Beforeinitialuse,placethemainbatteryonthechargerforatleast5seconds,asthebatteryis

shippedinahibernating,partiallycharged,condition.

Slot

Locking tab

Module battery

1Modulebattery

2Poweradapter(ACcordnotshown)

3DCplug

4DCinlet(withcover)

5Mainbatterychargeindicator

6Powerindicator

7Modulebatterychargeindicator

8Mainbattery

9Chargingbay

22Chapter2:GettingStarted989803173791 Rev 0.6

WAR NIN G

DonotuseortakethepoweradapterinsidetheMRsystemroom.Thedeviceismagneticand

willbepulledintotheMRsystem.Thedeviceisintendedforusewiththemainbatteryandthe

modulebatteryonlywhenoutsidetheMRsystemroom.

Tochargebatteriesfollowthesesteps:

Step Action

1Pressthepowerswitchforatleast1secondtoturnoffthe

monitor.

2 Removethemainbattery;seeRemovingthemainbattery,above.

3 Removethemodulebattery;seeRemovingthemodulebattery,

above.

4Insertthemodulebatteryintothechargingbayonthemain

battery.(Thechargingbayiskeyedforproperbatteryinsertion;do

notforcethebattery.)

5 RemovethecoverfromtheDCinletonthemainbattery.

6ConnecttheACcordtotheACinletonthepoweradapter.

7ConnecttheACcordtoanACoutletlocatedoutsideoftheMR

systemroom.

989803173791 Rev 0.6Chapter2:GettingStarted 23

Monitor Overview

Themonitorisanintegrateddevicethathousescommunication,display,processingandpower

technologies(includingthetransceiversandantennas).Themonitorhasthefollowinguser

features:

CAUTION

Whenusingthemonitor,ensurethatyourviewofthedisplaypanelremainsunobstructed.

8ConnectthepoweradaptertotheDCinlet.

Observethepower(PWR)indicatorand

verifythatpowerisapplied:

• Green=DCpowerisconnected.

•None=Nopowerisconnectedoran

errorwasdetected.(Ensurethatthe

poweradapterisproperlyconnected

totheACoutlet.)

9Allowbothbatteriestofullycharge,as

indicatedbythechargeindicators:

• Green=Chargingcomplete

• Yellow=Batterycharging

•None=Nobatteryisinstalledoran

errorwasdetected.

10 DisconnectthepoweradapterfromtheDCinlet.

11 Removethemodulebatteryfromthechargingbay.

12 Insertthemodulebatteryintothemodule;seeInstallingthe

modulebattery,above.

13 Insertthemainbatteryintothemonitor;seeInstallingthemain

battery,above.Thiscompletestheprocedure.

24Chapter2:GettingStarted989803173791 Rev 0.6

1.Powerswitch()‐Controlspowertothemonitor,wherepressingtheswitchformorethan

0.5secondsturnspoweron,andpressingtheswitchformorethan1secondturnspoweroff.

NOTE

Ifcommunicationshavenotbeendetectedfor15minutes,themonitorwillautomaticallyturnoff.

2.Handle‐Providesportabilityandhousestheantennas.

3.Speaker‐Providesaudiblepromptsandalarmindications,atamaximumvolumeofupto85

dB;seeSoundMenuinChapter3fordetails.

4.Alarmlight‐Providesa360degreevisualalertforalarmconditions,glowingyelloworred,

dependingupontheconditiondetected;seeManagingAlarmsinChapter4fordetails.

5.Displaypanel‐Providesvisualinformationandistheall‐touchinterfaceforoperation,control

andsetupofthemonitor.

Wireless SpO2 Module Overview

Thewirelesspulseoximetry(WSpO2)moduleprovidesthepatient’sreadings,asdetectedsignals

areconvertedthentransmittedforprocessinganddisplay.Themodulehasthefollowinguser

features:

1Powerswitch

2Handle

3Speaker

4Alarmlight

5Displaypanel

23 4

989803173791 Rev 0.6Chapter2:GettingStarted 25

1.Networkselectionbutton‐Selectsthenetworksettingofthemodule.

2.Sensorconnector‐ConnectsthemoduletotheSpO2QuickConnectsensor.

3.Statusindicator‐Indicatesthepowerandcommunicationconditionsofthemodule:

4.Networkicons‐Indicatethewirelessnetworkdesignatedformodulecommunications,where

theilluminatedicondenotesthecurrentnetwork.

Assigning the Module Network

Themodulecommunicatesthroughabidirectional2.4GHzspread‐spectrumlink,whichis

automaticallyestablisheduponmonitorpower‐up.Thewirelessnetworkcanbechangedas

neededtocomplywiththerequirementsofyouroperatingenvironment,butshouldalways

1Networkselectionbutton

2Sensorconnector

3Statusindicator

4Networkicons

StatusindicatorMeaning

Color State PowerCommunication

None Not

applicable

Thebatteryisnotinstalledoritlacks

sufficientchargetopowerthemodule. Notapplicable

Green Flashing Batterypowergood Notcommunicating

Green Solid Batterypowergood Goodcommunications

Red Flashing Lowbatterycondition

(lessthat45minutesremain) Notcommunicating

Red Solid Lowbatterycondition

(lessthat45minutesremain) Goodcommunications

26Chapter2:GettingStarted989803173791 Rev 0.6

matchthesettingassignedtothemonitor;seeNetworkMenuinChapter3formonitorsetup

details.

Thewirelessnetworkforthemoduleisindicatedbyitsilluminatedicon,whilethecurrently

assignednetworkforthemonitorisindicatedbythenetworkbuttononthedisplaypanel.

CAUTION

Forsystemcommunications,themonitorandmodulemusthavethesamenetworksetting.

Changing the Module Network Setting

Thewirelessnetworkforthemoduleischangedviaitsnetwork

selectionbutton,locatedbeneaththeoverlay,inthefrontupper

leftcornerofthedevice.(Aslightbumpcanbefeltwhenyoupassa

fingeroverthebutton.)

Whenselectinganetworkforthemodule,placethemoduleona

flatsteadysurface,orholditasshownintheillustration,anduse

yourthumbtopressthenetworkselectionbutton.

Beforestartingtheprocedure,takenoteoftheseconventionsthat

areusedtoexplaintheprocess:

•Intheprocedurebelow,thefollowingsymbolsareusedtoconveythestateofthenetwork

icononawirelessmodule.

•Intheprocedurebelow,thefollowingillustrationsareusedtoconveyactionsconcerning

theuseofthenetworkselectionbutton:

Iconilluminated Iconflashing

Pressthe

button

Releasethe

button

Pressandhold

thebutton

Repeatas

desired

989803173791 Rev 0.6Chapter2:GettingStarted 27

NOTE

Anypartoftheabovesequencenotcompletedwillcausethemoduletoreverttothenetwork

previouslyset30secondsafterthenetworkselectionbuttonwaslastreleased.

Toassignthewirelessmoduletothemonitor’snetworkfollowthesesteps:

Step Action

1 Identifythenetworksettingofthemonitor,asindicatedbythe

networkbutton.



2 Removethemodulebatteryfromthemodule;seeModuleBattery,

above.

3Installthemodulebattery.Thenetworkiconswillflashbrieflyand

thenthecurrentnetworkiconwillilluminate(forexample,

NetworkCintheillustrationbelow).

NOTE

Dependinguponyourmodule,thenetworkiconsmayhaveletteror

numericdesignators;and,thoughtheseexamplesshowletter

designators,theprocessisthesamefornumericdesignators.

Network button

28Chapter2:GettingStarted989803173791 Rev 0.6

4Setthenetworkofthemoduletothesamenetworkasthemonitor

(seeStep1).Enterthenetworkchangemode.Afterthecurrent

networkiconhasbeenilluminated(andwithin15secondsfrom

modulepower‐up)pressandholdthenetworkselectionbutton

untilthecurrentnetworkiconbeginsflashingrapidly.Thenrelease

thenetworkselectionbutton.

NOTE

Ifthenetworkchangesequenceisnotstartedwithin15seconds

afterthemodulehasbeenturnedon,anetworkchangewillnotbe

allowed.Youmustcyclemodulepowerandrestartthesequence.

5Changingthenetwork,pressthebuttonagainuntiltheiconstops

flashing,thenreleasethebutton.Whenyoudothis,thenext

networkiconinthesequencewillblinkrapidly.(Inotherwords,if

themodulewasoriginallyusingnetwork“C,”nowthe“D”iconwill

beflashing.)Repeatthissequenceofpressingandreleasingthe

buttonuntiltheiconofthenetworkyoupreferisrapidlyflashing.If

youpassthedesirednetwork,simplycontinuepressingand

releasingthebuttonuntilthedesirednetworkisflashingagain.

Step Action

989803173791 Rev 0.6Chapter2:GettingStarted 29

Initial System Power-Up

Toapplypowertothesystemfollowthesesteps:

Step Action

6Whenyoureachthedesirednetwork,pressandholdthebuttonfor

approximately5secondstolockandsavethenewnetwork.The

selectednetwork'siconwillturnoffwhilethebuttonisdepressed.

Thenitwillilluminate(notblink)whenthenewnetworksettingis

saved.Onceilluminated,releasethebutton.Themodulewillbegin

usingtheselectednetwork.

WAR NIN G

Ifthemessagebox,“WARNING!Multiplewirelessmodules

detectedonnetwork”isdisplayed,amodulenetworksetting

conflicthasbeendetectedbythemonitor.Beforeproceeding,for

properfunction,ensurethatonlyoneSpO2modulepernetwork

hasbeenassignedandisbeingused.

Step Action

1Ensurethatthemainbatteryisinstalledinthemonitor;seeMain

Battery,above.

2Ensurethatthemodulebatteryisinstalledthemodule;seeModule

Battery,above.

30Chapter2:GettingStarted989803173791 Rev 0.6

3Pressthepowerswitchforatleast0.5secondstoturnonthe

monitor.

4Thefirsttimethemonitoristurnedon,setthedisplaylanguagefor

thesystem:

NOTE

Itcantakeupto30secondsuntiltheboot‐upprocesshasfinished

andthemonitorbecomesready.

•IntheLanguagemenu,selectadisplaylanguagebytouching

acorrespondingLanguagebutton;seeNavigatingtheMenu

GroupsandControlsinChapter3fordetails.

(Ifnotsetinitially,theLanguagemenuwillcontinuetoappearat

subsequentpower‐upsuntiladisplaylanguageisselected.)

Step Action

Language buttons

989803173791 Rev 0.6Chapter2:GettingStarted 31

5Ensuresufficientmonitorpowerbycheckingthemainbattery

indicators,where:

•Graygaugeandtime=BatterypowerOK,timeremaining

fieldindicatesapproximateremainingchargeinhoursand

minutes.

• Flashingyellowgaugeandtime=Lowbatterypower(45

minutesorlesspowerremaining).

•NoBatteryCommunicationssymbol=No

communicationsbetweenthemonitorandthemainbattery.



Step Action

Main battery indicators

32Chapter2:GettingStarted989803173791 Rev 0.6

6Ensuresufficientmodulepowerandcommunicationswiththe

monitorbycheckingthemodulebatteryindicators,where:

•Bluegaugeandtime=BatterypowerOK(timeremaining

fieldindicatesapproximateremainingchargeinhoursand

minutes)andgoodcommunications.

• Flashingyellowbatterygaugeandtime=Lowbatterypower

(45minutesorlesspowerremaining).

•NoCommsymbol=Nocommunicationsbetween

themonitorandthemodule.



7VerifyproperoperationoftheSpO2parameter;seeChapter4.

Step Action

Module battery indicators

989803173791 Rev 0.6Chapter2:GettingStarted 33

Display Panel Overview

Thedisplaypanelprovidesthefollowingfunctionsandinformation:

1SpO2waveform

2SpO2messagearea

3Speakerbutton

4Alarmsbutton

5Informationalmessagearea

6DemoModeindicator

7Patientcategorybutton

8SpO2parameteridentifier(inpercent)

9SpO2highalarmlimitindicator

10 SpO2vitalsignnumeric

11 SpO2lowalarmlimitindicator

12 Heartrate(HR)parameteridentifier(inbeatsperminute)

13 Heartratehighalarmlimitindicator

14 Heartratevitalsignnumeric

15 Heartratelowalarmlimitindicator

16 MainScreenbutton

17 Setupbutton

18 Networkbutton(dependentuponthenetworkselection)

19 Mainbatteryindicators

20 Modulebatteryindicators

21 AlarmsPausebutton

22 AlarmsSilencebutton

23 Perfusionindexvalue

*****

3456

34Chapter2:GettingStarted989803173791 Rev 0.6

NOTE

Displayupdateperiodistypically1second,uptoamaximumof30seconds.

1.SpO2waveform‐Providestheplethysmographicwaveform,fixedacrossthescreenand

updatedwithanerasebar,wherearedwaveformindicatesanalarmcondition;seeWaveform

andVitalSignInformationinChapter4fordetails.

2.SpO2messagearea‐DisplaysSpO2relatedmessages.Foralisting,seeSystemMessagesin

Chapter4fordetails.

3.Speakerbutton‐Setsthevolumeforalarmtone,touchandpulsetones;seeSoundMenuin

Chapter3fordetails.

4.Alarmsbutton‐SetsthehighandlowalarmlimitsforSpO2andheartratealarms;seeSetup

MenuinChapter3fordetails.

5.Informationalmessagearea‐DisplaysalarmmessageswhentheAlarmsPausebuttonorthe

AlarmsSilencebuttonisselected.Foralisting,seeSystemMessagesinChapter4fordetails.

6.DemoModeindicator‐Indicatesthatthemonitorisoperatingindemonstrationmode;see

ServiceMenuinChapter3fordetails.

7.Patientcategorybutton‐Indicatesandallowschangestothepatientcategory;seePatient

MenuinChapter3fordetails.

8.Parameteridentifier‐IndicatestheSpO2parameterandunitofmeasurement.

9.SpO2highalarmlimitindicator‐Indicatesandallowschangestothehighlimitsettingforthe

SpO2alarm;seeAlarmLimitsMenuinChapter3fordetails.

10.SpO2vitalsignnumeric‐IndicatestheSpO2vitalsignofthepatient(givenasapercentage)

andallowschangestotheSpO2alarmlimits;seeWaveformandVitalSignInformationinChapter

4fordetails.

NOTE

Normalresponsetimeofthenumericsisapproximately10seconds;however,incaseofartifactor

poorsignalconditions,theupdateperiodcanbelonger.

11.SpO2lowalarmlimitindicator‐Indicatesandallowschangestothelowlimitsettingforthe

SpO2alarm;seeAlarmLimitsMenuinChapter3fordetails.

12.Parameteridentifier‐Indicatestheheartrateparameterandunitofmeasurement.

13.Heartratehighalarmlimitindicator‐Indicatesandallowschangestothehighlimitsetting

fortheheartratealarm;seeAlarmLimitsMenuinChapter3fordetails.

989803173791 Rev 0.6Chapter2:GettingStarted 35

14.Heartratevitalsignnumeric‐Indicatestheheartratevitalsignofthepatient(giveninbeats

perminute)andallowschangestotheheartratealarmlimits;seeWaveformandVitalSign

InformationinChapter4fordetailsfordetails.

NOTE

Normalresponsetimeofthenumericsisapproximately10seconds;however,incaseofartifactor

poorsignalconditions,theupdateperiodcanbelonger.

15.Heartratelowalarmlimitindicator‐Indicatesandallowschangestothelowlimitsettingfor

theheartratealarm;seeAlarmLimitsMenuinChapter3fordetails.

16.MainScreenbutton‐Closesanyopenmenus,returnsthedisplaytothenormaloperating

view,andcanlockthescreen;seeLockingandUnlockingtheScreeninChapter3fordetails.

17.Setupbutton‐OpenstheSetupmenu;seeSetupMenuinChapter3fordetails.

18.Networkbutton‐Opensthenetworksetupmenu;seeNetworkMenuinChapter3for

details.

19.Mainbatteryindicators:

•Displaystheremainingmainbatterypowerasagaugeandatimeremaining

counter(formattedinhours:minutes).Whenlessthanforty‐five(45)minutesremain,the

timewillflashinyellowandanalarmwillbedeclared;seeManagingAlarmsinChapter4

fordetails.

•Flashes

theNoBatteryCommunicationssymbolifcommunicationsarenot

established,orhavebeenlost,betweenthemonitorandthemainbattery.

20.Modulebatteryindicators:

•Displaystheremainingmodulebatterypowerasagaugeandatimeremaining

counter(formattedinhours:minutes).Whenlessthanforty‐five(45)minutesremain,the

timewillflashinyellowandanalarmwillbedeclared;seeManagingAlarmsinChapter4

fordetails.

•FlashestheNoCommsymbolifcommunicationsarenotestablished,orhavebeen

lost,betweenthemonitorandthemodule;alsoseeNoDataAvailableIndicationin

Chapter4fordetails.

21.AlarmsPausebutton‐Allowsyoutotemporarilydeactivatealarmfunctions,whereduring

deactivationa2minutetimer,flashinginred,willcountdownintheinformationalmessagearea;

seeManagingAlarmsinChapter4fordetails.

22.AlarmsSilencebutton‐Allowsyoutomutethealarmsoundandturnoffthealarmlight

duringanalarm(thoughindicationswillcontinuetoappearintheinformationalmessagearea,

andthealarmingnumericwillcontinuetoflash).Anewalarmwillcausereactivationofalarm

functions.Whenselected,the“AlarmsSilenced”message,flashinginred,willbedisplayedinthe

informationalmessagearea;seeManagingAlarmsinChapter4fordetails.

23.Perf‐Istheperfusionindex,anumericvaluefortheportionofthemeasuredsignalcaused

byarterialpulsation;seeWaveformandVitalSignInformationinChapter4fordetails.

36Chapter2:GettingStarted989803173791 Rev 0.6

989803173791 Rev 0.6Chapter3:PreparationforUse37

Chapter 3: Preparation for Use

TheEssentialMRIPatientMonitor(Model865353)providestheflexibilityneededtoperform

standardSpO2monitoring,whileallowingyoutocustomizeoperationstofityourneeds.

Warning

WAR NIN G

Alwaysverifypropercommunicationsbetweenthemoduleandmonitorpriortopatientuse.

CAUTIONS

•Avoidtheuseofcellularphonesorotherradio‐frequencytransmittersintheproximityof

anoperatingsystem.

•AminorbutnoticeabledegradationinthewirelessSpO2radiocommunicationswilloccur

inthepresenceofhigh‐poweredradios.

Using the Monitor

ObserveallwarningsandcautionswhenusingtheEssentialMRIPatientMonitor(Model

865353).

Warning

WAR NIN G

KeeptheEssentialdisplayoutoftheMRsystemboreandavoidcontactwiththepatient’sbare

skinwhiletheMRIscanisrunning.Thedeviceiselectronicandsusceptibletoexcessiveheating

fromtheMRIscanRFonlyifplacedinsidetheboreoftheMRsystemduringthatscan.Failure

todosomayresultinpatientinjury.

Warning

WAR NIN G

DonotuseortakethepoweradapterinsidetheMRsystemroom.Thedeviceismagneticand

willbepulledintotheMRsystem.Thedeviceisintendedforusewiththemainbatteryandthe

modulebatteryonlywhenoutsidetheMRsystemroom.

38Chapter3:PreparationforUse989803173791 Rev 0.6

System Parameters

TheEssentialMRIPatientMonitor(Model865353)facilitatesprocessinganddisplayofthe

plethysmographicwaveform,andtheassociatednumericvaluesandalarmsfortheoxygen

saturationofarterialbloodandthederivedheartrate.Allpatientinformationisprovidedonthe

displaypanel.

Navigating the Menu Groups and Controls

ThemenugroupsandcontrolsfortheEssentialMRIPatient

Monitor(Model865353)areaccessedandnavigatedby

touchingtheactiveareasonthetouchscreen.

Touchinganactivebuttonorindicatorwithyourfingerora

passiveobject(suchasastylus)willcausethesystemto

produceatouchtoneandopenthatmenuorselectthat

option,settingorvalue.(Notethatsimultaneouslytouching

twoormoreareasofthescreenmayproduceunpredictable

results.)

Toguardagainstaccidentalchanges,alockingfeatureallows

youtoprotectthemonitorsettings.

CAUTION

Neverusesharpobjectsonthedisplaypanelorapplyunnecessarypressuretothedisplaypanel,

asactioncanresultinscreendamageorfailure.

Controlling Menu Changes

Dependinguponthemenu,thesebuttonscontrolchangesmadetotheoptionsandsettings:

NOTE

Ifamenuisopen,delayingselectionofanoptionforlongerthan30secondsclosesthemenu.

•ConfirmandClosebutton:Touchtosavechangesandclosethemenu.

•Closebutton:Touchtodiscardchangesthatrequireconfirmationandclosethe

menu.(Ortouchanotherbutton.)

989803173791 Rev 0.6Chapter3:PreparationforUse39

•MainScreenbutton:Touchtocloseanopenmenu(andsaveanychanges‐

exceptthosethatrequireconfirmation)andreturntothenormaloperatingview.

Locking and Unlocking the Screen

Thetouchscreencanbelockedtoprotectagainstaccidentalchangestothesetuporalarm

controls,whileallowingmonitoringfunctionstocontinue.Whenlocked,thetouchscreen

functionswillbeinaccessible,asdenotedbythe“ScreenLocked”messagewhichwillappearfor

about2.5secondsafterabuttonorindicatoristouched.Torestoreoperationtoalockedscreen,

pressandholdtheUnlockScreenbuttonforabout3seconds.Lockingandunlockingmethodsare

describedbelow.

NOTE

TheMainScreenbuttonisdynamic,changingtoreflectthecurrentstateofthedisplaywhere

“MainScreen”indicatesanunlockedconditionand“UnlockScreen”indicatesalockedcondition.

Tolockthescreen:

TouchtheMainScreenbuttonforabout3seconds.

Tounlockthescreen:

TouchtheUnlockScreenbuttonforabout3seconds.

Main Screen button

40Chapter3:PreparationforUse989803173791 Rev 0.6

Patient Menu

ThePatientmenuallowsyoutoselectthepatientcategory.

Determiningtheappropriatepatientcategory

Eachsafetyagencyrecognizesthatthepatientcategorydescriptionscanbearbitraryandthat

thefollowingpatientfactorsaremoreaccurateindeterminingtheappropriatemethodof

patientmonitoringandtreatment:

•Weight

•Bodysize

•Limbcircumference

• Physiologicaldevelopment

•Neurological

development

• Neuromuscularcoordination

CAUTION

Theremaybeoccasionswhenaparticularpatientcategoryisnotsuitableforitsapparent

categorizationbasedonlyonage.Inthesecases,aclinicaldecisionshallbemadetouseanother

patientcategoryormeasurementtechnique.Theclinicaldecisionshallbebasedonallofthe

factorslistedinDeterminingtheappropriatepatientcategory(above)toensurethebestpossible

andmosttimelymeasurementacquisitions.

NOTES

•Thepatientcategorybuttonisdynamic,changingtoreflectthecurrentpatientcategory.

•Alarmlimitdefaultsettingsareappliedwheneverthepatientcategoryischanged,and

previouslychangedalarmsettingsforacertainpatientcategorywillbelost;seeAlarm

LimitsMenu(below)fordetails.

Unlock Screen button

989803173791 Rev 0.6Chapter3:PreparationforUse41

ToenterthePatientmenu:

TouchthePatientcategorybutton.

Thefollowingoptionsareavailable:

•Adult:Allowsyoutosetthemonitoringfunctionsforadultpatients.

•Pediatric:Allowsyoutosetthemonitoringfunctionsforpediatricpatients.

•Neonatal:Allowsyoutosetthemonitoringfunctionsforneonatalpatients.

Setup Menu

TheSetupmenuoptionsconfigurethealarmlimits,adjustthebrightnessofthedisplaypaneland

accesstheservicefunctions.

ToentertheSetupmenu:

TouchtheSetupbutton.

Thefollowingoptionsareavailable:

Patient menu

Patient category

button

Setup button

Setup menu

42Chapter3:PreparationforUse989803173791 Rev 0.6

•AlarmLimits:AllowsyoutoaccesstheAlarmLimitsmenu(seebelow).

•Brightness:Allowsyoutosetthedesiredintensityofthedisplay,where:

–3(Brightest)

–2(Bright)

–1(Normal)

NOTE

BrightnessoptionshigherthantheNormalsettingwillreducebatteryruntime.

•Service:AllowsyoutoaccesstheServicemenu(seebelow).

Service Menu

TheServicemenuallowsyoutoexaminethestatusofthehardwareandsoftwarerevisionlevels,

andtosetthelanguagedisplayedbythemonitor.Otheroptionsremainreservedforuseby

qualifiedserviceproviders,asnotedbelow.

ToentertheServicemenu:

TouchtheSetupbuttonandthenService.

Thefollowingoptionsareavailable:

•Status:AllowsyoutochecktheRealTimeClock,andtodisplaythecommunicationstatus

ofthemoduleandthemainbattery.

Setup menu

Setup button

Service menu

989803173791 Rev 0.6Chapter3:PreparationforUse43

•RevisionInfo:Allowsyoutoexaminethefirmwareandsoftwarelevelofthebootloader,

applicationandpowerprograms.

•DemoMode:Allowssystemoperationstobesimulated;seetheservicemanualfordetails.

NOTE

Thecorrectpasswordisrequiredforaccess:12151.

Warning

WAR NIN G

TheEssentialMRIPatientMonitor(Model865353)isequippedwithasimulationmodethat

displayscomputergenerateddatafortrainingpurposes.Asasafetyfeature,a“DemoMode”

messageisdisplayedwhileinsimulationmode.Donotattachapatienttothesystemwhenin

simulationmodeanddonotactivatesimulationmodewhenapatientisconnectedtothe

system.Thesystemwillnotmonitorpatientswhileinthesimulationmode.Failuretoproperly

monitorthepatientwillresult.Toexitsimulationmode,turnoffDemoModeusingthemenu,

orpoweroffthemonitor,orremovethebattery.

•Radio:Allowsaserviceprovidertochangetheradioandtotestradiopower;seethe

servicemanualfordetails.

NOTE

Thecorrectpasswordisrequiredforaccess.

•Language:Allowsyoutosetthelanguageusedtodisplaymenus,messagesandinterface

items,wherethefollowingoptionsareavailable:

– English

–Espanol

–Deutsch

– Francais

–Nederlands

–Dansk

–Svenska

– Italiano

–Norsk

–Portugues

44Chapter3:PreparationforUse989803173791 Rev 0.6

Network Menu

TheNetworkmenuallowsyoutosetthenetworkusedbythemonitorto

communicatewiththe

WSpO

module.Forpropercommunications,themonitorandmodulemustbelinkedonthesame

network.Foreaseofidentification,

networkselectionbuttonshaveuniqueshapes,designators

andcolors.

(Tochangethemodule’snetworksetting,see

AssigningtheModuleNetwork

in

Chapter2

.)

Warning

WAR NIN G

Ifthemessagebox,“WARNING!MULTIPLEWIRELESSMODULESDETECTEDONNETWORK”is

displayed,recheckthedesiredconfigurationofthemoduleandmonitor.Inenvironments

wheremultiplesystemsarebeingused,youmustbeawareofeachsystem’snetworksetting.

Operatingmultiplesystemsonthesamenetwork(orwithanincorrectnetworksetting)will

interferewithcommunications,andincorrectpatientvitalsignsinformationmaybeobtained

anddisplayedasaresult.Beforeproceeding,youmustresolvetheconflictingassignments.

NOTE

Thenetworkbuttonisdynamic,changingtoreflectthecurrentnetworksetting.

ToentertheNetworkmenu:

TouchtheNetworkbutton.

ThefollowingoptionsareavailablebypressingtheassociatedNetworkselectionbutton:

•



(Network1):

Allowsyoutos

et

systemcommunicationsforwirelessnetwork1



(compatibility

withaPrecessMRIPatientMonitorandmodule,Model3160‐Blueversion)

•(Network2):

Allowsyoutos

et

systemcommunicationsforwirelessnetwork2

(compatibility

withaPrecessMRIPatientMonitorandmodule,Model3160‐Blueversion).

Network menu

Network button

Network selection buttons

989803173791 Rev 0.6Chapter3:PreparationforUse45

•(Network3):

Allowsyoutos

et

systemcommunicationsforwirelessnetwork3

(compatibility

withaPrecessMRIPatientMonitorandmodule,Model3160‐Blueversion)

•(Network4):

Allowsyoutos

et

systemcommunicationsforwirelessnetwork4

(compatibility

withaPrecessMRIPatientMonitorandmodule,Model3160‐Blueversion)

•(Network5):

Allowsyoutos

et

systemcommunicationsforwirelessnetwork5

(compatibility

withaPrecessMRIPatientMonitorandmodule,Model3160‐Blueversion)

•(NetworkA):

Allowsyoutos

et

systemcommunicationsforwirelessnetworkA

(compatibility