Medtronic NIM-Response 2.0 User manual

Brand: Medtronic

Model: NIM-Response 2.0

Type: User manual

NIM-Response

2.0

Nerve Integrity Monitor

USER’S GUIDE

Language Order

EN/ES/FR/PT/EL

Rx Only

NIM-Response

2.0 Helpline

1-800-874-5797

For Questions and Service

NIM-Response

2.0

™ are trademarks and

are registered marks of Medtronic Xomed, Inc.

HP DeskJet™ is a trademark of Hewlett Packard Company

Manufacturer:

Medtronic Xomed, Inc.

6743 Southpoint Drive North

Jacksonville, FL 32216-0980 USA

Authorized Representative (for EC regulatory matters)

Medtronic B.V.

Earl Bakkenstraat 10

6422 PJ Heerlen

The Netherlands

Tel.: 011-31-45-566-8000

Fax: 011-31-45-566-8668

Patents Pending

2005 Medtronic Xomed, Inc.

Made in U.S.A.

This device complies with MDD 93/42/EEC.

The information contained in this document was accurate at time of publication. Medtronic Xomed reserves the right

to make changes in the product described in this manual without notice and without incorporating those changes in any

products already sold.

Table of Contents Page

Explanation of Symbols Used in the Labeling .................................................................................................. 1

1.0 Customer Service Information ............................................................................................................ 2

2.0 Introduction ......................................................................................................................................... 3

2.1 Device Description .............................................................................................................................. 3

2.2 Indications for Use .............................................................................................................................. 3

2.3 Contraindications ................................................................................................................................. 3

2.4 Unpacking the NIM-Response® 2.0 ................................................................................................... 3

2.5 The Front Panel ................................................................................................................................... 3

2.6 The Rear Panel .................................................................................................................................... 4

2.7 The Patient Interface ............................................................................................................................ 4

2.8 The Muting Probe ................................................................................................................................ 5

2.9 The NIM-Response® 2.0 Patient Simulator ........................................................................................ 5

3.0 Warnings and Precautions ................................................................................................................... 6

4.0 Powering Up the NIM Console ........................................................................................................... 9

4.1 Self test ................................................................................................................................................ 9

4.2 Touch Screen Calibration .................................................................................................................... 9

5.0 Audio – Understanding What You Hear .............................................................................................. 9

5.1 Alarms ................................................................................................................................................. 9

5.2 EMG Audio ......................................................................................................................................... 10

6.0 Screen and Control Descriptions ......................................................................................................... 11

6.1 General User Interface Overview ........................................................................................................ 11

6.2 Settings: EMG Tab .............................................................................................................................. 12

6.3 Settings: Audio Tab – Selecting audio options .................................................................................... 13

6.4 Settings: Display Tab – Display Adjustments ..................................................................................... 13

6.5 Settings: System – Adjusting System Information .............................................................................. 14

6.6 Patient Information .............................................................................................................................. 14

6.7 The Main Display ................................................................................................................................ 15

6.8 Reading the EMG Screen .................................................................................................................... 15

6.9 Stimulator adjustments ........................................................................................................................ 15

6.10 Adjusting the Event Threshold ............................................................................................................ 16

6.11 Other EMG screen adjustments / selections ........................................................................................ 17

7.0 Special Functions and Features ........................................................................................................... 19

7.1 Channels .............................................................................................................................................. 19

7.2 Muting ................................................................................................................................................. 19

7.3 Event Threshold, Auto, Event Capture and “Largest” ......................................................................... 20

7.4 Freeze .................................................................................................................................................. 21

7.5 Quick Help ........................................................................................................................................... 21

7.6 Event Log ............................................................................................................................................ 21

7.7 View Event (Waveform Data) ............................................................................................................. 21

7.8 Output Device Button (Print or Save) ................................................................................................. 21

7.9 Volume Control .................................................................................................................................... 21

7.10 Edit a Channel Label ........................................................................................................................... 22

7.11 Electrode Placement Screen ................................................................................................................ 22

7.12 Recognizing Artifact ............................................................................................................................ 22

7.13 Manufacturing Test .............................................................................................................................. 22

8.0 Operating Room Set-Up ...................................................................................................................... 23

8.1 Typical Set-Up ..................................................................................................................................... 23

8.2 Recommended Patient Interface Set Up .............................................................................................. 23

8.3 Electrodes ............................................................................................................................................ 23

8.4 Stimulator ............................................................................................................................................ 24

8.5 Muting Probe Set up ............................................................................................................................ 25

8.6 Anesthesia Requirements .................................................................................................................... 25

9.0 How to Monitor ................................................................................................................................... 26

9.1 Standard Set-Up (Using “Mastoid” as an example) ............................................................................ 26

9.2 Custom Set-Up .................................................................................................................................... 28

9.3 Saving a Set-Up ................................................................................................................................... 30

10 Cleaning and Maintenance .................................................................................................................. 31

10.1 Cleaning (after each use) ..................................................................................................................... 31

10.2 Fuses .................................................................................................................................................... 31

10.3 Storage ................................................................................................................................................. 31

10.4 Service and Repair Procedures ............................................................................................................ 31

11.0 Troubleshooting ................................................................................................................................... 32

12.0 Technical Specications ...................................................................................................................... 34

13.0 Guidance and manufacturer’s declaration – electromagnetic immunity and emissions ..................... 36

14.0 Limited Warranty ................................................................................................................................. 39

Appendix A: NIM-Response® 2.0 System Components & Accessories........................................................ 40

Appendix B Preventive and Corrective Maintenance ....................................................................................... 41

 PowerOff/PowerOn M  TypeBFAppliedPart

 RadioButton Volume

 Select/Deselect

 CheckBox Help

 Select/Deselect

 ExitPop-UpWindow Fuse

 PatientCable O CEMarkPerMDD93/42/EEC



 Input/Output  Headphoneout



 PrinterOut BipolarStimulatorProbe



 AudioOut MonopolarStimulusReturn 

  (Anode)



 MonopolarStimulusProbe VoiceMonitoringScreen

 (Cathode) Control-On

 ToneMonitoringScreen

 Control-On Thisportisforfutureuseonly

 Equipotential IP21 Indicationofthedegreeof

  protectionoftheenclosure:

  1

Number:2–protectsagainstngers

  touchinghazardousparts2

Number:1

  –equipmentisminimallyprotected

   fromdripping.

Explanation of Symbols Used in the Labeling

RF Transmitter (Interference

mayoccur)

1.0 CUSTOMER SERVICE INFORMATION

U.S. Customer Service Contact Information

Generalcustomerserviceandtechnicalsupportareavailabletoll-free:

800-874-5797or904-296-9600

Monday-Friday:8:00AM–6:00PME.S.T.

www.xomed.com

Microelectronics Repair

TechnicalSupport:

800-872-9877

904-296-6448(FAX)

Monday-Friday 8:00AM–5:00PME.S.T.

www.xomed.com

Return Address:

MedtronicXomed,Inc.

6743SouthpointDriveNorth

Jacksonville,FL32216-0980USA

Attn.:RepairDepartment

Customer Service Information

Forfurtherinformationregardingtheuseofthisproductortoreportanyproblems,pleasecontactMedtronicXomed

usingtheappropriateinformationprovidedontheblueandwhitecontactinformationcardpackagedwitheachdevice;or

contactyourlocaldistributor.

The NIM Helpline.

Shouldyouneedimmediatehelpwithatechnicalquestionorguidancethroughtheappropriateprotocol,justcallthe

NIMHelpLineat1-800-874-5797.

Note: WhencontactingourCustomerServiceandTechnicalSupport,pleasehavetheappropriateproduct

number,productserialnumber,dateofpurchase,andnatureofinquiryavailable.



 ProductNumber:___________________________

 

 SerialNumber: ___________________________



 DateofPurchase:___________________________

A: TheTouch ScreendisplaysEMGwaveforms

andcontrolsmanyofthefunctionsoftheNIM

Console.

B: TheSpeakerprovidesaudioalarms,acoustic

 EMGmonitoring,andvoiceprompts.

C: TheSoftware Versioninstalledisdisplayed

 onthestart-up“splashscreen”.



NIM-Response

2.0

2.0 INTRODUCTION

2.1 Device Description

TheNIM-Response

2.0isafour-channelEMGmonitorforintraoperativeuseduringsurgeriesinwhichamotornerve

isatriskduetounintentionalmanipulation.TheNIM-Response

2.0recordselectromyographic(EMG)activityfrom

musclesinnervatedbytheaffectednerve.Themonitorwillassistearlynerveidenticationbyprovidingthesurgeonwith

atooltohelplocateandidentifytheparticularnerveatriskwithinthesurgicaleld.ItwillcontinuouslymonitorEMG

activityfromthemusclesinnervatedbythenerveatrisktominimizetraumabyalertingthesurgeonwhenaparticular

nervehasbeenactivated.

2.2 Indications for Use

Thisdeviceisintendedforuseinsurgicalproceduresforpatient-connectedintraoperativenervemonitoring,i.e.assisting

thesurgeoninlocatingandmappingmotornervesthroughtheuseofelectromyographic(EMG)signalsandelectrical

stimulusofnerves.

Thisdeviceisindicatedforlocatingandidentifyingcranialandperipheralmotornervesduringsurgery.

2.3 Contraindications

Theuseofparalyzinganestheticagentswillsignicantlyreduce,ifnotcompletelyeliminate,EMGresponsestodirector

passivenervestimulation.Whenevernerveparalysisissuspected,consultananesthesiologist.

2.4 Unpacking the NIM-Response

2.0

WhenyouunpacktheNIM-Response

2.0,savethecartonsandpackingmaterialinwhichyourmonitorarrived.Ifthe

instrumentistobeshippedfromonelocationtoanother,thecustomdesignedshippingpackagewillprovidethebest

protection.

Whentheboxisunpacked,checkoffthecontentsoftheboxagainsttheitemslistedonthepackingslip.Ifthecontents

areincomplete,orifthereisdamage,notifyMEDTRONICXOMEDCustomerService.Iftheshippingcontaineris

damaged,orthecushioningmaterialshowssignsofstress,notifythecarrieraswell.Keeptheshippingmaterialsfor

carrierinspection.

2.5 The Front Panel

2.6 The Rear Panel

AllconnectionstotheNIM-Response

2.0consoleareviatherearpanel.Pleaseconnectaccessoriesinstrict

accordancewiththeinformationbelow.

2.7 The Patient Interface

 ThePatientInterfaceandcableprovidethemeansforconnectingthepatienttotheNIM-Response

2.0console.

TheNIM-Response

2.0patientinterfacehasfourcolorcodedpairsofelectrodeinputs,agroundelectrodeinputjack,

astimulusreturninputjack,plusthestimulatoroutputthatisconguredtoacceptmonopolarorbipolarstimulating

probes.

A: Chassis Ground

B. USB Out:TheUSBOutisanindustrystandardUSBtype

connector(twoport)thatcanbeusedwithmassstorage

devices.Note:Seeyoursalesrepresentativeforfurther

informationonthecorrectCFCardandreader.

C. VGA Output:AVGAoutputisavailablethroughthe

standardVGA15pinconnectoronthebackpanel.The

NIM-Response

2.0canbeconnecteddirectlytoaVGA

monitor.

D. Mini Jack:Standardcongurationisforprivatelistening

throughStereoHeadphones.

E. Printer Port:TheprinterportisaCentronicsprinterport

thatcanbeusedwithstandardindustrysupportedprinters.

F. Muting Probe Inputs:TherearefourMutingProbe

Inputs.

G. Power Connector:Thepowercordplugsintothe

backoftheNIM-Response

2.0console.Theinput

fusesandaccessoryoutputisinthepowerentry

module.PlugthepowercordintotheA/Cpower

outlet.

H. Power Switch:Thepowerswitchturnsthepower

ONorOFF.

I. Fuse Access:TheACpowerfusesarelocatedonthe

backoftheunits.

J. Patient Interface Connector:Thepatientinterface

connectorisa25-pinD-sub.

K. Factory / Custom Mode Switch:TheFactory/

Custommodeswitchallowstheunittobereturned

tooriginalfactorysettings.TheCustommode(“C”)

allowstheusertosaveCustomcongurations.

L. Accessory Power Outlet:TheAccessoryPower

OutletpowersperipheraldevicesusedwiththeNIM

Console.

M.RCA Audio Jack:AnRCAaudiojackisprovided

tooutputanaudiosignalthatcanbeoverlaidontoa

videosignalwhenusingindustrystandardrecording

devices.Theoutputwillbeaudiolinelevel(1Vp-p).

N.Forfutureuseonly.

Important:

IntraoperativeuseoftheVGAOut,RCAPhone

Jack,andUSBCompactFlashDriverequiresspecial

considerationstoremaincompliantwithUL2601

(IEC60601-1).ContactMedtronicXomedfor

recommendationsifintraoperativeuseoftheVGA

Out,RCAPhoneJack,orUSBCompactFlashDriveis

Monitoring Electrodes

Twoelectrodesperchannel,plusagroundelectrode,arerequired.

(Groundconnectorjack)

Theelectrodepairsforeachchannelplugintothecolor-codedpairedjacksasindicatedabove.

Stimulator Connections

Thestimulatoroutputscanbeconnectedappropriatelyformonopolarandbipolarstimulatingprobes,as

shownbelow.

Monopolar Stimulation:

Inputs  ConnectionDiagram

Intheappropriatemulti-channelelectrodeset,theredelectrodewiththewhitewireisusedfor

monopolarstimulation,asthestimulusreturn(anode).Plugtheredconnectorofthewhiteelectrode

intothewhitejackwiththeredring(+).

Plugtheblackmonopolarstimulatorprobeconnectorintotheblackjack(-).Theprobedelivers

currenttothepatient(cathode).

TheauxiliaryjackmarkedAUX(-)canbeusedifmorethanonemonopolarstimulatorprobeis

required.Insuchacase,boththeprobessharethesamestimulatorsettings.

Bipolar Stimulation

Inputs  ConnectionDiagram

Whenbipolarstimulationisrequired,onlyonestimulatorprobecanbeused.Thebipolarstimulator

cablehasaredandablackconnector.Plugtheredconnectorintothewhitejackwitharedring

(+).Plugtheblackconnectorintotheblackjack(-).TheblackAUX(-)jackcannotbeusedinthis

application.

2.8 The Muting Probe

TheMUTINGPROBEisdesignedtodetectthepresenceofnoisefromexternaldevicesthatmaycauseinterferenceon

theEMGmonitor.Thisisdonebydetectingcurrentowthroughtheexternaldevice’scables.Intheoperatingroom

environment,anelectrocautery/electrosurgicalunitisatypicalsourceofthisinterference.

Themutingprobeisattachedtotheelectrosurgicaldevicebyclampingitaroundtheactivecauterycable(notthereturn

padcable).Inasimilarmanner,itmaybepossibletoconnecttheMutingProbetootherequipmentthatmaycause

interferencesuchasaCUSA,electricdrills,etc.(seeSection7.2).

2.9 THE NIM-Response

2.0 Patient Simulator

TheNIM-Response

2.0PatientSimulatorisintendedtoserveasa“patient”forthemonitoringconsole.Itmaybeused

bothfortraining/demonstrationpurposesandasatroubleshootingaidinanon-clinicalsetting.

Forcompletedetailsofoperation,pleaseseethePatientSimulatorUser’sGuidethataccompaniesthesimulator.

3.0 WARNINGS AND PRECAUTIONS

ItisimportantthattheNIM-Response

2.0operatorbefamiliarwiththismanual,itsprecautions,proceduresandsafety

issues.Threelabelsareusedinthismanualtoidentifyimportantconcerns,conditions,orprocedures:

• Warnings: Describesseriousadversereactionsandpotentialsafetyhazardsthatcanoccurdur-

ing   theproperorimproperuseofadevice.

• Precautions: Anyspecialcaretobeexercisedbyapractitionerorpatientforthesafeandeffective

  useofthedevice.

• Additional Precautions: Identiesconditionsorpracticesthatcouldresultindamagetothe 

   equipment.

Warnings

W1 TheNIM-Response

2.0doesnotpreventthesurgicalseveringofnerves.Ifmonitoringiscompromised,

the surgical practitioner mustrely on alternatemethods, or surgicalskills,experience, andanatomical

knowledgetopreventdamagetonerves.

W2 Toavoidpatientburns:

 W2a DonotactivateelectrosurgicalInstrumentwhilethestimulatorisincontactwithtissue.

 W2b Donotleavestimulatingelectrodesorprobesinsurgicaleld.

 W2c DonotstorestimulatingelectrodesorprobesinelectrosurgicalInstrumentholder.

 W2d Donotallowasecondsurgeon(i.e.fatharvesting)touseelectrosurgicalinstrumentwhilestimulator

isinuse.

 W2e Specialoperatorattentionmayberequiredforstimuluscurrentsexceeding2mARMS/cm2.The

RMSvalueofcurrentisgenerallylowerthanthestimulatorcurrentsettinginmA.TocalculateRMS

current,waveformmorphology,pulsewidth,repetitionrate,andthestimulatorcurrentdelivered

mustbeconsidered.

W3 WhileMutingisactivated,auditoryandvisualmonitoringaredisabled.

W4 Toavoidfalsenegativeresponses,verifystimulatorcurrentsettingishighenough,andverifystimulus

deliverybytone,voice,ordisplay.Lowstimulatorcurrentmaycauseafalsenegativeresponse.

W5 Highstimulatorcurrentmaycauseinvoluntarypatientmovementresultinginpatientinjury.

W6 High stimulator current activating ofthe fth cranialnerve or Mastication muscles maycause tongue

lacerations.

W7 Falsenegativeresponses(failuretolocatenerve)mayresultfrom:

 W7a ShortedEMGelectrodeorcabling(conductivepartsofappliedneedleelectrodesorcablescontacting

eachother).

 W7b PatientInterfacefuseblown(32mA,250V.XomedPartNo.:8250615).

 W7c PatientInterfacedefective.

 W7d Inadequatestimuluscurrent.

 W7e Inadequatecurrentforstimulationofnervethroughhardware,suchasstimulusdissectioninstruments,

mayvarybasedonthephysicalsize,shapecharacteristics,anddesignofthehardwareandproximity

tothenerve.

 W7f Neuromuscularfatiguefromprolongedorrepeatedexposuretoelectricalstimuli.

 W7g InadvertentsimultaneouscurrentdeliveryfrombothStimulator(PatientInterface)probeoutputs.

Thismayresultincurrentshunting,divisionbetweenthestimulatorprobes.

 W7h Shortedinternalamplier(characterizedbybaselineactivityof<3µVp-p)

W8 Donotpower-ontheNIM-Response

2.0whenthestimulatorisinthesurgicaleld.

W9 Toavoideyeinjuryduringelectrodeplacement,theelectrodeneedlesshouldbedirectedawayfromthe

globeandadequatelysecuredwithtape.

W10 Toavoidtheriskofreorexplosion,donotusetheNIM-Response

2.0inthepresenceofammable

anestheticsand/oroxygenrichenvironments.

W11 Toavoidelectricalshock,donotattachunapprovedcomponentsoraccessoriestotheNIM.

W12 ToavoidtheriskofinfectionwhileusingtheNIM-Response

2.0touchscreenstylus,theusermustmaintain

goodsterilitypractices.

W13 ElectrocardiogrammonitoringartifactsmaybecausedbyNIM-Response

2.0stimuluscurrentdeliveryor

EMGelectrodeimpedancemonitoring.

W14 Directstimulatorcontactmaydisrupttheoperationofactiveimplanteddevices.

W15 Whilestimulating,itisrecommendedtouseonlyapprovedEMGmonitor(s)equippedwithactiveaudio

and/orvisualcurrentdeliveredfeedbacksystemstoensuredeliveryofcurrenttointendedtissues.

W16 Properhandling,insertion,andplacementofelectrodesandprobesiscriticalforsafeandaccurateEMG

monitoring:

 W16aImproperlyplacedorbentneedlesincreasetheriskofneedlebreakingoffinthepatient.

 W16bDonotattempttostraightenbentneedlesbecausethismaycausestressandweakendevice,causing

needletobreakoffinpatient.

 W16cExtremecaremustbetakenwhenhandlinginstrumentswithsharppointsoredges.

W17 Thesurgicalpractitionermustchoosetheappropriatesizeelectrodesandprobesbasedontheprocedureto

beperformedandthestimulatingcurrentnecessaryfortheapplication.

W18 Avoid trans-thoracicstimulation;whenpossible,maintainanodeandcathode stimulatingsitesinclose

proximity.

W19 Reuseofsingleuseelectrodesandprobesincreasetheriskofinfectionandmaycausedegradedorineffective

monitoring.

Precautions

P1 Specialcaremustbeexercisedtodistinguishbetweenthehigh-pitchedbeepoftheEventTones(EMG

activityoverthreshold),andtheStimulusWarbleTone(indicatesthesetcurrentisbeingdelivered).

P2 When the “BleedleAlarm” (BLEE-dle-DEET) sounds, the cause must be identied and eliminated

immediately.

P3 Toavoidloud,extraneousmonitoringnoiseduringelectrosurgicalunitactivation,ensuretheMutingProbe

isproperlyattachedtotheactiveelectrosurgicallead.

P4 Inadequatestimuluscurrentowmaybecausedbynon-ushcontactbetweenthestimulatingelectrodeor

probeandthenerve,inadequatestimulatorprobeelectricalcontactsurfacearea,orhighimpedance.

P5 Inabilitytodeliverstimuluscurrentowmaybecausedby:

 P5a Stimulatorreturnelectrodenotconnected,orotherincompleteelectricalconnectionbetweenthe

NIM-Response

2.0,monitoringelectrodeandstimulatorprobe.

 P5b STIM1(EMG)PatientInterfacefuseblown(32mA,250V,REF8250615).

 P5c Stimulussetto0.00mA.

 P5d Defectivestimulatingelectrodeorprobe.

P6 ToavoidfalsepositiveEMGevents(stimulusartifacts):

 P6a Ensuretherecordingelectrodesandthestimulator(+)or(-)cablingareroutedseparatelyandnot

tangled.

 P6b EnsureEMGground(greenwire)isphysicallyplacedbetweenthestimulatorreturnelectrode(white

wirewithredplug)andtheEMGchannelinputelectrodes.

P7 ProperplacementandsetupoftheelectrosurgicalunitawayfromtheNIM-Response

2.0willreduceor

minimizeunnecessarymuting,interference,andoffsets.

P8 Useofunapprovedstimulators,stimulusprobes,stimulus-dissectioninstrumentsorelectrodesmayresult

incompromisedNIM-Response

2.0operation,suchas,butnotlimitedto,decreasedaccuracy.

P9 Electrodeintegrityshouldbe checked (on the “electrodes”screen)afterelectrodeinsertionandbefore

electroderemovaltogiveadditionalassurancethatelectrodecontinuitywasmaintainedthroughoutthe

entireprocedure.Ifelectrodeimpedanceisveryhigh,discontinueuseandreplace.

P10 ThePatientInterfacecable,andMutingProbecableshouldbesecuredtotheoorwithtapeorothernon-

tripdevice.

P11 Excessiveorinsufcientmutingmayresultfromimpropermutinggain.Forexcessivemuting,movethe

MutingProbetoalowerjacknumber.Forinsufcientmuting,movetheMutingProbetoahigherjack

number.Standardpositionisnumber3.

P12 Toavoidexcessivemuting:

 P12a DonotplacetheNIM-Response

2.0incloseproximitytotheelectrosurgicalunit.

 P12b DonotplacePatientInterfaceorelectrodewiresincloseproximitytotheelectrosurgicalunitor

electrosurgicalunitwires.

 P12c Avoidhigh-powerelectrosurgicalunitmonopolarsettings.Notethatmutingcausedbyelectrode

chargingmaylastseveralsecondsafterelectrosurgicalInstrumentuse.

 P12d Be aware of external sources that may induce muting including cellular phones, diathermy,

electrocauteryusedinadjacentoperatingrooms,orothersourcesofelectromagneticinterference.

P13 Avoidaccidentalcontactbetweenconnectedbutunappliedelectrodesandotherconductiveparts.

P14 Contaminatedsingleuseelectrodesandprobesmustbedisposedofinanappropriatesharpsbiohazard

containerinaccordancewithhospitalorotheruserfacilitiespolicy.

P15 Forextra-ocularmonitoring,itisrecommendedthatelectrodeplacementbedoneunderthedirectionofa

neurologistorophthalmologist.

P16 T h e  P a t i e n t  I n t e r f a c e  s a f e t y  f u s e  u s e d  i n  a l l  N I M  P a t i e n t  I n t e r f a c e s

BoxesfortheStimulatorOutputarespecicallytestedforECUprotection. 

UseXomed11270048Fuse,5x20mm,32mA,250V.Order8250615FuseKitforreplacements. 

Additional Precautions

AP1 Toavoidsystemdamage,donotconnectanydeviceother thanNIM-Response

2.0MutingProbesinto

anyofthefourmutingprobeinputsontherearpaneloftheNIM-Response

2.0.

AP2 DisconnectthepoweroftheNIM-Response

2.0oraconnectedprinterbeforecleaning.Topreventcleaning

solutionsfromseepingintotheelectronicportionsoftheinstrument,spraycleanerlightlyonacottoncloth,

thenwipetheinstrumentwiththecloth.Beespeciallycarefularoundthecontrols,connectorsandpanel

edges.Donotuseabrasivecleaners(especiallyonthetouchscreen).

AP3 Repairand/ormodicationtotheNIM-Response

2.0,oranyaccessorybyanyoneotherthanqualied

servicepersonnelmaysignicantlycompromisetheunitsabilitytomonitornerveactivityand/orvoidthe

equipmentwarranty.Forbestperformance,itisrecommendedthatallservicebeperformedbyMedtronic

Xomedservicepersonnel.The Manufacturing Test is not intended for end users and is to be used only

under the direct supervision of Medtronic Xomed Personnel (see section 7.13).

AP4 MedicalElectricalEquipmentneedsspecialprecautionsregardingEMCandneedstobeinstalledandput

intoserviceaccordingtotheEMCinformationprovidedinthisGuide.

AP5 PortableandmobileRFcommunicationsequipmentcanaffectMedicalElectricalEquipment.

AP6 Use of accessoriesand cables otherthan those speciedand soldby Medtronic Xomedmay result in

increasedemissionsanddecreasedimmunityofthisunit.

AP7 TheNIM-Response

2.0shouldnotbeusedadjacenttoorstackedwithotherequipment.Ifadjacentor

stackeduseisnecessary,theNIM-Response

2.0shouldbeobservedto verifynormaloperationinthe

congurationinwhichitwillbeused.

4.0 POWERING UP THE NIM-Response

2.0

4.1 Self testAninternalintegritycheckisautomaticallyperformedeachtimethesystemisturnedON. (See Warning W8)

OnPower-upaseriesofmessagesarebrieydisplayedincludingthesoftwareversionnumberandrevisiondate,thenthe

consoledoesaseriesofself-testsonthehardware:

MASTER PROGRAM - Masterprogramlesarecheckedforintegrity.

MASTER RAM - Checkedtoensureenoughextendedmemoryexists.

TOUCH PROGRAM - Thetouchscreencontrollerischeckedforthecorrectrevisionnumber.

TOUCH RAM - ThetouchscreencontrollersRAMischeckedbywritingtoeachlocation.

WATCHDOG TIMER - Thetouchscreencontrollerscommunicationlinkistested.

A TO D SPEED - ThedisplayshowstheAnalogtodigitalspeedtestresults.

SYSTEM MEMORY - Thememoryischeckedfortheexistenceofthecongurationles.

LANGUAGE–Thedisplayshowstheselectedlanguage.

CONFIGURATION – Thedisplayshowsthecurrentconguration(factoryorcustom).

4.2 Touch Screen Calibration

Ifthetouchscreenrespondsinanunexpectedmannerorregistersapressinthewrongareaofthescreen,itmayneed

calibrating.

Note:

Forthehighestaccuracy,itisrecommendedthatyoucalibratethescreenusingastylusratherthanangertip.

Calibrate the screen as follows:

1. TurnthepowerOFFforatleast5seconds,andthenturnitONagain.

2. Whenthe“SplashScreen”(withthedevicenameandMedtroniclogo)appears,

 pressthescreenuntilyouarepromptedtoremoveyourhandbythetextmessage

“Pleaseremoveyourhandfromthescreentocontinue”.

3. Thescreenwillthendisplaytwobuttons,thelargeoneatthetopislabeled:

“TouchScreenCalibration”.

 Pressthisbutton.

4. Thescreenwillthendisplaythetextmessage:“Touchthelowerleftofthescreen”

 -preciselypressthelowerleftcornerofthedisplayscreen.

5. Thescreenwillthendisplaythetextmessage:“Touchtheupperrightofthescreen”

 -preciselypresstheupperrightcornerofthedisplayscreen.

6. Thescreenwillthendisplaythetextmessage:“Presscircletoverifycalibration”

 -preciselypressthecenterofthecircledisplayedonthescreen.

7. Ifthetouchscreendoesnot“sense”thenaltouchasbeinginthecenterofthedisplayedcircle,thecalibration

 sequencewillrepeat.Onsuccessfulcompletionofthecalibration,theNIMwillenternormaloperatingmode.

5.0 Audio – Understanding What You Hear

TheNIM-Response

2.0NerveMonitorproducesmanydifferentsoundsthroughoutsurgicalprocedurethatrequire

understandingbythepersonperformingmonitoring.InadditiontoEMGsounds,variousbeepsandvoicesprovideuseful

information.

5.1 Alarms

Thealarmsdrawattentiontoanycondition,whichpreventspropermonitoring.Noneoftheaudiblealarmsshouldbe

ignored.Onemustassumethatvalidmonitoringhasstoppedanddetermineimmediatelywhythealarmsounded.There

arethreedistinctalarms:

 5.1.1 BEEP Alarm

Thehigh-pitched,repetitivebeepisusedtoregisterfailureofinternalmicroprocessorhardware.

Ifyouhearitatanytimeotherthanatpowerup,stopusingtheNIM-Response

2.0Systemandcontact

MEDTRONICXOMEDCustomerService(seeSection2).

 5.1.2 BLEEDLE Alarm

Thisisathree-notealarm(BLEE-dleDEET)thatcannotbedisabled.Itrepeatsuntiltheresponsibleconditionis

remedied.Thealarmisheardunderthefollowingconditions:

•CheckElectrode-Contactwithanelectrodeislost.Onthemainmenuthechannelinquestionwillbe

ashing.After20seconds,theelectrodeImpedancescreenwillturnon.Thebleedlealarmwillrepeatevery

20Secondsuntiltheconditionisremedied.Thisisfollowedoncebythe“CHECKELECTRODE”voice

unlessthishasbeendisabled.

• Muting-TheNIM-Response

2.0SystemhasbeeninMUTEmodeformorethan30seconds(unlessyou

areinELECTRODECHECK).Thebleedlealarmisfollowedoncebythe“MUTING”voiceandwill

repeatevery30secondsuntiltheconditionisremedied.

5.1.3 Voice Alarms

Therearetwovoicealarmsthatareselectable,andworkinunisonwiththebleedlealarm.Theycanbeturned

onoroffandhavevolumecontrols.Thesealarmsare“checkelectrodes”and“muting,”andaredescribedin

5.1.2.

5.1.4 Voice Annunciation

Thereareseveralvoiceannunciationtypes,stimulationdeliveryconrmation,numericstimulatorcurrent

values,andactivationofautothreshold.

NIM-Response

2.0Voices:

Point Five Baselineincreased

Zero Six Checkelectrodes

One Seven Electrodes

Two Eight Muting

Three Nine Stimulus

Four Baselinedecreased

Precautions

P1 SpecialcaremustbeexercisedtodistinguishbetweentheEventTones(EMGactivityover

 threshold),andtheStimulusTone(indicatesthesetcurrentisbeingdelivered).

P2 Whenthe“BleedleAlarm”(BLEE-dle-DEET)sounds,thecausemustbeidentiedand

 eliminatedimmediately.

5.2 EMG Audio

TheEMGaudioistheampliedsoundofmuscleactivitythatisheardinstantaneouslyasthenerveisstimulated.All

EMGactivity,regardlessofamplitude,isaudiblewhentheEMGaudioisON.TheEMGactivitymaysoundlikealow-

pitched“drumbeat”,ahigh-pitched“crackle,”ora“growl”.Whenmultiplechannelsaremonitored,itisunlikelythat

youwillbeabletodifferentiatetheEMGsignalsastotheirchanneloforiginstrictlybythesoundstheyproduce.

5.2.1 Event Tones

EventTonesareheardwhentheEMGamplitudeislargerthantheEventThresholdsetting.TheEventTones

areeasilyheardoverO.R.noiseandareheardatthesametimewiththeEMGaudio,previouslymentioned.

TheEventTonesaredifferentforeachchannelsothatthechanneloforigincanbedistinguished.Thetonefor

channel1activityislowerinpitchthanthechannel2toneandsoonforchannels3and4.Thisletsyoutell

bythetone’spitchwhichchannelisinvolved.WhenEMGactivityexceedingtheeventthresholdoccursatthe

sametimeonmultiplechannels,onlytwoofthetonessoundatonce.

5.2.2 Baseline – Voice

TheNIM-Response

2.0hastwo(2)baselinevoices:“BASELINEINCREASED”-“BASELINE

DECREASED”.

ThesevoicesareusedaspartoftheAutoEventThresholdfeaturewhenautomaticadjustmentsaremade.

PleaseseetheAutoEventThresholdsectionofthemanual.

5.2.3 Stimulus

 5.2.3.1 Stimulus - Tone

Thestimulustoneannouncesthedeliveryofcurrenttothepatient.

• IfSTIMULUS,CONTINUOUSisused,thendeliveryofstimuluscurrentisaccompaniedbya

continuous,warbled,high-lowtone(referredtoas“StimulusWarbleTone”).

• IfSTIMULUS,BRIEFisused,thendeliveryofstimuluscurrentisaccompaniedbyabrief

warbledtone.

Note:Stimulustoneswillnotsoundforstimuluscurrentlevelsbelow0.05mA.Stimulustonesarenot

heardifanEventTonehasbeengenerated.

 5.2.3.2 Stimulus - Voice

  Thestimulusvoiceannouncesthedeliveryofcurrenttothesurgicaleldbyvoice.

• “STIMULUS”VOICE

With“Stimulus”,deliveryofcurrenttothesurgicaleldisannouncedbytheword,

“STIMULUS”.Itmaybeturnedonoroffandhasvolumecontrol.

• “SETTING”VOICE

The“Setting”voiceannouncesthevalueoftheSTIMULUSsetting.Italsoannouncesanynew

stimulussettingwhenadjustmentsaremade.Example:0.50mAwouldbeannouncedas“Point

Five”.Itmaybeturnedonoroffandhasvolumecontrol.

Note:Settingvoiceor“Stimulus”voicewillnotsoundforstimuluscurrentlevelsbelow0.05mA.

StimulusvoicesarenotheardifanEventTonehasbeengenerated.

5.2.4 Other EMG Responses

6.0 SCREEN AND CONTROL DESCRIPTIONS

6.1 General User Interface Overview

Thetouch-sensitiveareasofthescreenprovideinformationandcontroloptions.Someoftheseoptionsare:

6.1.1 Preference / Control Options

6.1.2 Channel Button

Warnings

W3WhileMutingisactivated,auditoryandvisualmonitoringaredisabled.

Action

ChannelButton

ToggleButton-turnschannelOn/Off.If“ChannelMute”

isselected(Settings/Audio)buttonrotatesthroughaseries

ofOn/Offfunctions.

ChannelNumber

DisplaysChannelNumber.

MicroVoltActivity

MuscleGroupName

On/OffIndicator

BellIcon

SpeakerIcon

DisplaysBaselineActivityorEventpeakvalue.White

boxindicateschannelwithhighestlevelofactivity.

DisplaysnameofMuscleGroupassignedto

IndicatesOn/Offstatusofchannel.

IndicatesthatEventTonesareturnedon,andcanbe

turnedOff/OnusingtheChannelButton.

IndicatesthatEMGAudioisturnedon,andcanbeturned

Off/OnusingtheChannelButton.

If“Channel

Mute”is

selectedat

Settings/Audio

Illustration

Name

On/OffIndicator

RadioButtons

CheckBoxes

ScrollButtons

CoarseAdjustButtons

FineAdjustButtons

ForpreferenceselectionwhereselectingoneRadioButton

willautomaticallydeselectanother.

Forpreferenceselection.

Forviewingalist.

Forroughorfastadjustment.

Forne-tuningofanadjustment.

Action

Illustration

Name

6.1.3 Volume

6.2 Settings: EMG Tab



 Pressthe“EMG”,“Electrodes”,“Settings”and“Patient”tabstotogglebetweentheprimaryscreens.Forsaving 

settings,pleaseseeSection9.3.

• Settingstimulatingoptions

• SettingFilter

SETTING: EMG

1.ChangetoAudioScreen.

AdjustingRate

1.Thebuttondisplaywilltogglethroughthepreset

valueswitheachpress.

FILTER-Anadjustabledelayallowingthesmall

amountofelectronicnoisecausedbystimulation

(StimulusArtifact)tostabilizebeforereadingEMG

data.

Movelterlineto

heretoavoidartifact.

Originallterlineshown

onMainDisplay

Action

Name

Illustration

Settings/Audio

VoiceVolume

Settings/Audio

HeadphoneVolume

MainScreen

Volume

TonesvolumeadjustmentsecondarytoMainScreen

Volume.

VoicevolumeadjustmentsecondarytoMainScreen

Volume.

HeadphonevolumeadjustmentsecondarytoMainScreen

Volume.

Mainorprimaryvolumeadjustment.Allothervolume

slidebarsaresubordinate.Exampleincreasingmain

volume10%increasesallvolumes10%.

Settings/Audio

TonesVolume

StimulusArtifact

AdjustingPulseWidth

1.Thebuttondisplaywilltogglethroughthepre

setvalueswitheachpress.

Fineadjustment

Coarseadjustment

6.3 Settings: Audio Tab – Selecting audio options

SETTINGS: AUDIO

1.Selectdesiredoptions.

2.ChangetoSettings:Display.

NOTE:

Ofthefourradiobuttons,Brief,Continuous,Voice

Setting,andStimulusVoicesoneisalwaysselected

whiletheotherthreeareautomaticallydeselected.

Tones

EMG Audio:AppliesRawEMGtothespeakers.

Event Tones:Anyeventisheardasabeep.

Channel Mute:Enablesthe“Tones”and

“Audio”iconsonthe“MonitoringScreen”.

EXAMPLE

Stimulus Audio

Brief:Stimulationisa“BLEE-dleDEETTone”.

Continuous:Stimulationisa“WarbleTone”.

Help Voices

Check Electrode:Soundswhencontactwithan

electrodeislost.

Muting:SoundswhensystemhasbeeninMUTEfor

morethan30seconds.

Stimulus Voices

Stimulus Voices:Stimulationisannouncedby

“STIMULUS”.

Voice Setting:Stimulationisannouncedbythe

setting.

Example:0.50mAwouldbeannouncedas“POINT

FIVE”.

Alsoannouncesnewsettingswhenstimulusis

changed.

SETTINGS: DISPLAY

6.4 Settings: Display Tab – Display Adjustments

EMG View

Select“Event Capture”or“Largest”fordisplay

onthemainscreen.

“Show on Main Display”enablesdisplaybuttons

for:

Freeze,QuickHelp,EMGScales(Timeand

Amplitude)onthemaindisplay.

EMG Scales, Amplitude and Time

ControlshowanEVENTisdisplayed.

• Amplitude-VerticalportionoftheEMG

display.

• Time-HorizontalportionoftheEMGdisplay.

Note:Changingthescalesonlyaffectshowthe

dataappearsonthescreen.Itdoesnotmodifythe

sensitivityoftheunit.

1.Selectoptionsand/oradjustAmplitudeandTime.

2.ChangetoSettings:System.

ExampleofMainDisplay

ShowingQuickHelp,Freeze,Time,AmplitudeandLargest

(left),EventCapture(right),buttonsonthemaindisplay.

Amplitude

Time

6.5 Settings: System Tab

SETTINGS: SYSTEM

Date/Time

Format:AM/PMor24hourclockandmonth-day-

yearorday-month-yeararrangement.

Date/TimeButtons:OpensKeypadforentering

Date/Time.

Output Device

UsedtoselectWHEREdataissent(Printeror

CompactFlash.

Output Type

Usedtoselecttheformatofthedataoutput.

Image  Screenimageissenttotheprinteror

  CompactFlash.

Text  Comma-delimitedEMGwaveform

  dataissenttotheprinter.

EventLog Thelast300detectedeventsaresentto

  theprinterorCompactFlashinalog

  outputformat.

Diagnostics Info –isforuseunderthesupervisionof

qualiedservicepersonnelONLY.

Language

Usedtoselectcurrentdisplaylanguage.

6.6 Patient Information

PATIENT INFORMATION

• AddPatient,PatientID,ProcedureandComments

toSavedorPrintedEvents.

Patient buttons

• Eachbuttonopensakeyboardfordataentry.

1.ChangetoMainDisplay(EMGTab).

1.Selectoptions.

2.ChangetoPatientScreen.

SetupName

ChannelButtons

Time

ScreenTabs

BasicAdjustmentButtons

PreferenceButtons

Print/SaveButton

Volume

6.7 The Main Display

6.8 Reading the EMG Screen

Theamplitudeofthesignalis representedbytheverticalportionoftheEMGdisplay.Theamplitudescaleisuser-

adjustable(seeSection6.11).Thescreenisdividedinto40divisionswitheachchannelcenteredat5divisions(2and

1/2positive,2and1/2negative).

Note:Changingthescaleonlyaffectshowthedataappearsonthescreen.Itdoesnotmodifythesensitivityoftheunit.

ThehorizontalportionoftheEMGdisplayrepresentstimeandthescaleisalsoadjustable(seeSec6.11).Thescreen

isdividedinto10divisions.Thisdiffersfromthe“Amplitudescale”inthatthe“Timescale”selectionistheentire

horizontalportionofthescreen.

Note:Changingthescaleonlyaffectshowthedataappearsonthescreen.Itdoesnotmodifythesensitivityoftheunit.

6.9 Stimulator adjustments

AdjustingtheStimulator.StimulatoradjustmentinvolvesthecurrentadjustmentshownhereaswellastheRate,Pulse

Width,andFilteradjustmentsshowninsection6.2.

Important Note:

Theabsolutestimulusintensityrequiredtoadequatelystimulateanymotornerveisdeterminedbyacomplex

combinationofseveralfactorsincluding(butnotlimitedto)thefollowing:

• Thefunctionalhealthofthenerveitself.

• Thetypeofstimulationprobeused(monopolarorbipolar).

• Proximitytothenerve.

• Thepulsewidthofthestimulus.

YoushouldusethesmallestamountofstimulusnecessarytoelicitadetectableEMGevent.Stimuluscurrentlevelsof

0.3mAmaybehighenoughforadequatedirectmonopolarstimulationofthefacialnerves,butmayelicitlittleorno

responsewhenmonitoringmotorevokedpotentials.Thebestguidelineforsettingthestimulusintensitylevelistouse

thelowestamountofstimulationthatproducesanEMGevent.

The surgeon should be aware:

• ThatSTIMULUSiscontinuouslybeingappliedtotheSTIMULATORprobe.

• STIMULATINGthepatientistheresultofphysicalcontactbetweenthepatientandtheSTIMULATORprobe.

• TheSTIMULATORprobeshouldbekeptISOLATEDwhenNOTSTIMULATINGthepatient.

EMG

EVENTAREA

Stimulator adjustments continued

MAIN DISPLAY (EMG SCREEN)

Noticeadditionaldisplayfeatures:

• Time,Amplitude,Freeze,andQuickHelp

(?Button)areturnedonatSettings:Display

Screen.

1.PressmAbuttontoopenadjustmentarrows.

6.10 Adjusting the Event Threshold

 SeeSection7.3fordetails.

• EVENTTHRESHOLDisahighlysensitivelter

usedtodenewhereEMGactivitybecomes

signicant.

• EMGactivityexceedingthis“THRESHOLD”is

denedasan“EVENT”andresultsinEventTones

(alarms)sounding.

Coarseadjustmentisinincrementsof50.0µV.

Fineadjustmentisinincrementsof5.0µV.

Note:Totaladjustablerangeis20µVto2500µV.

AdjustEventThreshold

AdjustStimulusCurrent

Resetsthestimulustozero

Note:Topreventinadvertenthighstimuluslevels,the

rsttimeinaprocedurewhenastimuluslevelexceeds

3mA,adialogboxwillopen:

STIM 1 LEVEL WARNING

Stim1inexcessof3mA

PressOKtoallowstimulus

Coarseadjustment.

Fineadjustment

Coarseadjustment.

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Medtronic NIM-Response 2.0 User manual

Medtronic NIM-Response 2.0 User manual

Medtronic NIM-Response 2.0 User manual

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