Rigel 344 User manual

RIGEL344 UserManualRev 2.0
RIGEL 344
Defibrillator Tester/PacerAnalyser/ ECGSimulator
Operating Manual
BrackenHill
SouthWestIndustrialEstate
Peterlee,CountyDurham
SR82SW,England
Phone:[phone] Fax:[phone]
www.rigelmedical.com

RIGEL344 UserManual 2
Copyright
Copyright ©2003by Rigel Medical,part ofSeawardElectronicLtd.All rights
reserved.No part ofthispublication maybereproducedortransmittedinanyform
otherthanforthepurchaser’spersonal usewithout writtenpermission fromSeaward
ElectronicLtd.
QualityAssurance
SeawardElectronicLtdisISO9001-2000Certified.Thisinstrument wasthoroughly
testedand inspectedaccording toSeawardElectronic’ISO9001-2000 qualitystandards
and test proceduresand found tomeet thosespecificationswhenit wasshippedfromthe
factory.
Warranty
Rigel Medical warrantstheRIGEL 344 against defectsinmaterialsand workmanship
foroneyearfrom thedateoforiginal purchase.Thestandardwarrantyisextendedfora
second yeariftheinstrumentisreturnedtoRigelMedical foritsrecommendedyearly
recalibration.
During thewarrantyperiod,wewill repairor,atouroption,replace atno chargea
product that provestobedefective,providedyou returntheproduct shipping prepaidto
Rigel Medical.Thiswarrantydoesnot applyiftheproduct hasbeendamagedby
accident ormisuseorastheresult ofservice ormodificationby otherthanRigel
Medical,orifitsserial numberisdefacedorremoved.
Rigel Medical reservestheright todiscontinuetheRIGEL 344 at any time,andchange
itsspecifications,price,ordesign without notice and withoutincurring any obligation.
Rigel Medical guaranteesavailabilityofservice partsfor5yearsafterthemanufacture
oftheunit isdiscontinued.
Thewarrantyisvoidifyouelect tohavetheunit servicedand /orcalibratedby
someoneotherthanRigel Medical.
Thepurchaserassumesall liabilityforany damagesorbodilyinjurywhichmayresult
from theuseormisuseoftheunit by thepurchaser,hisemployees,agents,or
customers. Innoevent shall SeawardElectronicLtdbeliableforconsequential
damages
Trademarks
Rigel Medical and RIGEL 344 aretrademarksofSeawardElectronicLtd.Any other
trademarknamesusedinthismanual areonlyforeditorial purposesand thebenefit of
therespectivetrademarkownerwithno intention ofimproperlyusing that trademark.

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TableofContents
1. GeneralOverview
1.1Introduction ------------------------------------------ 06
1.2SafetyConsiderations------------------------------------ 07
1.3Specifications ------------------------------------------ 08
1.4Accessories ------------------------------------------ 10
2. OperatingInstructions
2.1 Getting Started------------------------------------------ 11
2.2 InstrumentFamiliarity----------------------------------- 12
2.3 PowerUp and Initialisation ---------------------------- 13
2.4 Menu Structure-------------------------------------------- 13
2.5 Testing aDefibrillator------------------------------------16
2.5.1Energy Measurement---------------------------- 16
2.5.2PeakVoltageand Current-----------------------17
2.5.3Viewing WaveformOutput---------------------- 17
2.5.4Measuring Cardioversion (Sync.)Time------ 17
2.6Testing Semi/AutoDefibrillator---------------------- 18
2.6.1SelectingWaveforms----------------------------18
2.6.2Measuring Energy --------------------------------19
2.7Printing DefibrillatorMeasurementData-------------19
2.8ECGArrhythmiaSimulator----------------------------21
2.8.1GeneratingNormalSinusRhythm Waveform21
2.8.2GeneratingArrhythmiaWaveforms------------22
2.8.3ArrhythmiaWaveformDefinitions------------- 22
2.8.4AmplitudeSelection -------------------------------22
2.8.5GeneratingPerformance Waveforms-----------23
2.9Testing TransthoracicPacers --------------------------- 24
2.9.1SelectingPacerManufacturer-------------------24
2.9.2Selecting50 Ohm TestLoad------------------- 25
2.9.3SelectingVariableTestLoads------------------25
2.9.4Measuring PulseParameters-------------------- 25
2.9.5Measuring RefractoryPeriods----------------- 26
2.9.6Demand SensitivityTests------------------------27
2.9.7ImmunityTests-----------------------------------28
2.9.8Measuring Energy --------------------------------28
2.10 Testing ExternalTransvenousPacers (AV)---------- 29
2.10.1Measuring PulseParameters------------------- 29
2.10.2Measuring RefractoryPeriods----------------29
2.10.3Demand SensitivityTests---------------------- 30

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2.10.4ImmunityTests-----------------------------------31
2.10.5Measuring AV Interval------------------------32
2.10.6Measuring Energy ------------------------------ 32
2.10.7PacemakerTypeSelection ---------------------32
2.11 Printing PacerMeasurements-------------------------- 33
2.11.1PrintingWithoutaHeader---------------------33
2.11.2PrintingWithaHeader-------------------------33
2.12 AutomaticPacerTesting ---------------------------------34
2.13 PrinterFunctions-----------------------------------------34
2.14 AuxiliaryFunctions--------------------------------------36
2.14.1AV PacerTestFunction -----------------------36
2.14.2TranscutaneousPacerTestFunction--------37
2.14.3Calibration Check------------------------------37
2.14.4PrinterFormatSelection ----------------------38
2.14.5PacemakerBatteryCurrentTest-------------39
3. PalmPilotInterface
3.1 Introduction ------------------------------------------39
3.2RigelPalmSoftSetUpProcedure-------------- 39
3.3Receiving and Saving Data----------------------- 40
4. TheoryofOperation
4.1Introduction ---------------------------------------- 41
4.2DefibrillatorOutputMeasurement ------------41
4.3PacemakerOutputMeasurement ------------41
4.4Circuit BlockDescriptions----------------------- 42
5.TroubleshootingRIGEL 344 --------------------------- 45
6.Appendix------------------------------------------------------- 46

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ThisManualisprovidedtoexplaintheoperation oftheRIGEL344
DefibrillatorTester/PacemakerAnalyser/ECGSimulatortestinstrument.
Itisintendedforthebiomedicalengineering orclinicalengineering technician
involvedinthetesting ofdefibrillatorsandexternalpacemakers.
Theoperatormustbefamiliarwithandfollowthesafetyprotocols
recommendedby thedevice manufacturer.
SafetyNotes:
1. Before usingtheRIGEL 344 readtheinstructionmanualand
becomefamiliarwiththefunctions and controls.
2. Dischargeadefibrillatoronlyintothepaddlecontactsofthe
RIGEL 344.Donotdischargeadefibrillatorintoanyother
connectorsoftheRIGEL 344.
3. Theoperatinginstructions ofthemanufacturersofall
defibrillatorsand pacemakersbeingtestedmustbefollowed.
Specialattentionshouldbepaidtoautomaticandsemi-
automaticdefibrillators.
4. Donotconnecttransthoracicand transvenouspacemakers
simulataneously.Testonlyonetypeatatime.
5. Donotchangethevariablepacertestloadwhilea
transthoracicpacemaker isturnedon.Turnthepacemaker
off before selectingatestload.

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GENERALOVERVIEWSection1
1.1Introduction
The RIGEL 344 isabiomedicaltestinstrumentthatcombinesthe
completetesting functionsofadefibrillatortester,apacemakeranalyser,and
anECGarrhythmiasimulatorintoonecompactinstrument.
The Rigel344 isdesignedtoaccuratelymeasuretheoutputparametersof
defibrillators andexternalpacemakers,including bothtransthoracicand
transcutaneousdevices.Itsimulatesawidevarietyofarrhythmiawaveforms
fortesting automaticdefibrillatorsand ECGequipment.
Itiscompact,lightweight,and rugged.The Rigel344 isoperatedvia
easytousemenusdisplayedon itslargedisplay.ItmaybebatteryorAC
operated.
1.1.1DefibrillatorTestFunctions
TheRigel344 measuresthedeliveredenergy ofadefibrillatorinJoules
(watt –seconds).Thebuilt intestload(50Ohms)simulatesthehumanbody’s
resistance.Theenergy ismeasuredintworanges:0-100 Joules(LOW)or0–
1000 Joules(HI). ThePeakVoltageand Currentaredisplayed
simultaneously.
Thecardioversion delaytimeofadefibrillatorinitssynchronizedmodeis
measuredinmillisecondsfrom theRwavepeakofthesimulatedECG
waveform.
ThedefibrillatorpulsewaveformcanbereplayedviatheECGjackson the
sidepanelorthroughthepaddlestoprinton arecorderorview onan
oscilloscope.
1.1.2Pacemaker TestFunctions
TheRigel344 makesseveralmeasurementsoftransthoracicand
transvenous(A-V)pacemakers.
1.1.2.1TransthoracicPacers
Testload:50 Ohmsoruserselectableloadfrom 100 to1000Ohms.
Measures:Peakcurrent,pulsewidth,pulserate,pacedrefractoryperiod,
sensedrefractoryperiod,and pulseenergy.

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1.1.2.2TransvenousPacers
Measures:Peakcurrent,pulsewidth,pulserate,pacedrefractoryperiod,
sensedrefractoryperiod,immunitytest(50Hz/60 Hz), A/Vinterval,and
pulseenergy.
Measuresthecurrentdrain(ON/OFF) ofthepacemaker,using theoptional
adapter(PNxxxxx).
1.1.3ECG/ArrhythmiaSimulatorFunctions
TheRigel344 simulatesanormalsinusrhythm ECGwaveformalong with
severalarrhythmias.Italsogeneratessine,square,triangle,and pulse
performance waveforms.
1.2SafetyConsiderations
Beforeusing theRIGEL344,theoperatormustfollowthesafetyprecautions
listedinthismanual.
1.2.1Defibrillators
Defibrillators deliverhighvoltageshockstoapatientinordertostop aheart
attack.Thedefibrillatordischargepulseispotentiallydangerous.
1.2.2AutomaticDefibrillators
Automaticdefibrillatorsdischargeautomaticallywhentheydetectalife
threatening heartcondition,whichrequiresashock.
TheRIGEL344 simulatesavidevarietyofarrhythmiawaveforms.Whenthe
instrumentisconnectedtoanautomaticdefibrillatorand aventricular
fibrillation(VFB)orventriculartachycardiawaveformisselected,the
defibrillatorwill discharge.Thefullyautomaticdefibrillatorwillwarntheuser
thatit isabouttodischarge.Alwaysheedtheaudiblewarningsofthe
defibrillator.Usetherecommendedpaddleadapters forconnecting tothe
RIGEL 344.Do nottouchthepaddleorelectrodecontacts.

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1.3Specifications
1.3.1DefibrillatorTester
Energy Measurement
LoadResistance:50 Ohms ±1%Non Inductive.
Range(High): 1000Joules.
Resolution:1Joule.
Range(Low): 0–100 Joules.
Resolution:0.1Joules.
Maximum Voltage:5200 volts(HIRange), 1750 volts(Low
Range).
Maximum Current:100 Amp (HIRange),32 Amps(LowRange).
Accuracy:HIRange: ±2%oftheReading ±2Joules.
LOWRange: ±2%ofReading ±0.1Joule.
Cardioversion(Sync.)Time
Range:0-250 ms.
Measurement:From peakofRwave.
Accuracy:1%ofFullScale ±1ms.
DischargeWaveformOutput
RealTime:Output1000:0.5Volts.
Stored:Timeexpansion 200:1repeatedevery8seconds.
1.3.2ExternalPacer Analyser
1.3.2.1Transthoracic
TestLoad:50Ohms(Fixed).
and Variable100 to1000Ohmsuserselectable.
Current:1to200 mA.
Accuracy: ±5%+.5mA
PulseWidth:0.5to80 ms.
Accuracy: ±1%+.1ms.
Refractory:20–500 ms.
Accuracy: ±2%or+10ms.
1.3.2.2Transvenous(AtrialandVentricular)
TestLoad:500Ohms ±1%.
Current:1to25 mA.
Accuracy: ±5%+.5mA.
PulseRate:30 to800 ppm.
PulseWidth:0.5to80 ms.
Accuracy: ±1%+.1ms.