Medtronic NIM-Response 2.0 User manual

Medtronic
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
Copyright
©
2005 Medtronic Xomed, Inc.
Made in U.S.A.
This device complies with MDD 93/42/EEC.
O
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
1
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
st
Number:2–protectsagainstngers
touchinghazardousparts2
nd
Number:1
–equipmentisminimallyprotected
fromdripping.
Explanation of Symbols Used in the Labeling
RF Transmitter (Interference
mayoccur)
2
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:___________________________
3
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
4
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
5
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.
6
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needleelectrodesorcablescontacting
eachother).
W7b PatientInterfacefuseblown(32mA,250V.XomedPartNo.:8250615).
W7c PatientInterfacedefective.
W7d Inadequatestimuluscurrent.
W7e Inadequatecurrentforstimulationof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.
7
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singleuseelectrodesandprobesincreasetheriskofinfectionand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 “BleedleAlarm” (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.
8
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 thanNIM-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.
9
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.
10
• 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.
11
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
A
B
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.
C
Action
Illustration
Name
D
12
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
13
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
14
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.
15
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
16
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
Fineadjustment
Coarseadjustment.
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
  • Page 1 1
  • Page 2 2
  • Page 3 3
  • Page 4 4
  • Page 5 5
  • Page 6 6
  • Page 7 7
  • Page 8 8
  • Page 9 9
  • Page 10 10
  • Page 11 11
  • Page 12 12
  • Page 13 13
  • Page 14 14
  • Page 15 15
  • Page 16 16
  • Page 17 17
  • Page 18 18
  • Page 19 19
  • Page 20 20
  • Page 21 21
  • Page 22 22
  • Page 23 23
  • Page 24 24
  • Page 25 25
  • Page 26 26
  • Page 27 27
  • Page 28 28
  • Page 29 29
  • Page 30 30
  • Page 31 31
  • Page 32 32
  • Page 33 33
  • Page 34 34
  • Page 35 35
  • Page 36 36
  • Page 37 37
  • Page 38 38
  • Page 39 39
  • Page 40 40
  • Page 41 41
  • Page 42 42
  • Page 43 43
  • Page 44 44
  • Page 45 45
  • Page 46 46

Medtronic NIM-Response 2.0 User manual

Medtronic
Brand
Medtronic
Model
NIM-Response 2.0
Type
User manual
Download PDF
report

Ask a question and I''ll find the answer in the document

Finding information in a document is now easier with AI

Related papers

Other documents