Rigel 344 Manuel utilisateur

RIGEL344 UserManualRev 2.0

RIGEL 344

Defibrillator Tester/PacerAnalyser/ ECGSimulator

Operating Manual

BrackenHill

SouthWestIndustrialEstate

Peterlee,CountyDurham

SR82SW,England

Phone:+44 (0)191 586 3511 Fax:+44(0)191 5860227

www.rigelmedical.com

RIGEL344 UserManual 2

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

RIGEL344 UserManual 6

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.

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