Rigel 344 User manual
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.
RIGEL344 UserManual 3
RIGEL344 UserManual 4
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
RIGEL344 UserManual 5
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.
RIGEL344 UserManual 7
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.
RIGEL344 UserManual 8
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.
RIGEL344 UserManual 9
RIGEL344 UserManual 10
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.
RIGEL344 UserManual 11
Refractory:20–500 ms.
Accuracy: ±2%or+10ms.
ImmunityTest:50/60Hz.
1.3.3ECGArrhythmiaSimulator
ECGWaveform:
NormalSinusRhythm
Rates:30,60,80,120,180,240,300 BPM
Performance Waveforms:
Sine,Square,Triangle,and Pulse
Rates:0.5,1,2,10,15,20,25,40 Hz.
ArrhythmiaWaveforms:
VFBC,VFBF, VTAC,AFIB,PVC,PVC1,PVC2,BGY,RBB,
AFIB,AFT,PVCM.
Amplitudes:0.5,1,1.5,2,2.5,3mv.
Waveform Output:
LowLevel:12 LeadECGand Paddle
HiLevel:OutputJacks
Accuracy:
Rate: ±1%
Amplitude: ±2%(LA-LL), ±10%(Paddles)
1.3.4RS232 Output
Acomputerinterface isavailabletoprinttestresultsortosavethemon a
PC.ThetestresultscanbesaveddirectlytoaPalmPilotusing Rigel
Medical’soptionalpalmsoftware.
1.3.5Power Requirements
Two9-VoltAlkalineBatteriesorACadapter.
1.3.6PhysicalCharacteristics
1.3.6.1Dimensions
25.4x27.9x5.7cm
1.3.6.2Weight
1.9Kg
1.3.7EnvironmentalOperatingSpecifications
StorageTemperature:-25 to50oC
Operating temperature:15 to40oC
RIGEL344 UserManual 12
Maximum Humidity:95%RelativeHumidity
1.4Accessories
1.4.1StandardAccessories
Operating Manual650-USER-MANUAL
Carrying Case 650-CASE
UniversalPaddleAdapters(setof2) 653
UnterminatedBananaPlug (setof2) 6383-02
ECGSnapAdapters(setof10)1000
1.4.2OptionalAccessories
ACAdapter(110 VAC) 301 (110VAC)
ACAdapter(220 VAC) 301-220 (220VAC)
Printer DPM411
SerialPrinterInterface Cable 903
SoftwareforPC650-PC-SOFT
PalmPilotInterface Software 650-PALM-SOFT
PalmPilotInterface Cable650-PALM-CABLE
AEDPaddleAdapters:
HP651-HP
Zoll651-Zoll
PhysioControl 651-Physio
Marquette651-MARQ
Laerdhal 651-LAED
UniversalA/VPacerAdapterCable 652
PacemakerBatteryTestAdapterCable652-BATT
TranscutaneousPacerAdapters:
ZollCall forPartNumber
HPCall forPartNumber
PhysioControlCall forPartNumber
RIGEL344 UserManual 13
OPERATINGINSTRUCTIONS Section2
2.1GettingStarted
Beforeunpacking theRIGEL344 inspecttheshipping boxforany visual
damage.If damageisfound,do notunpacktheunit and immediatelynotifythe
shipping carrier.
If no damageisfound totheshippingbox,openthebox and performavisual
inspection oftheRigel344.If any damagetotheunit isobservedpleasecontact
RigelMedicalCustomerService.
TheRigelMedicalwarrantystatementislistedinthewarrantysection ofthis
manual.Whenshipping aninstrumenttoRigelMedicalforrepairorcalibration
makesurethattheinstrumentisproperlypacked.AcompletedtheService
ReturnFormmustbeincludedwiththereturnedinstrumenttoensurethetimely
repairand returnofyourinstrument.TheService ReturnFormmaybe
obtainedatourwebsite www.rigelmedical.com orfromtheRigelMedical
CustomerService Department.
RIGEL344 UserManual 14
2.2InstrumentFamiliarity
Beforeproceeding tousetheRIGEL344 makesureyoureadthismanualand
becomefamiliarwiththefunctionsall ofthecontrolsand themenu operation.
1. Defib.PaddleContacts:
Apex(R)Sternum(L)
2. SerialPort
3. ECGOutput–10Lead
4. ECGHiLevel
5. RealTimeOutput
6. Defib/PacerSelector
7. LCDDisplay
8. Function Keys
9. PowerSwitch
10. DCPowerInput
11. A/VPacerInput
12. PacerInputSelector
13. TranscutaneousInput
14. TranscutaneousInputLoadSelector.
2.3
6
9
10
11
12
13
7
8
14
5
4
3
1
2
10
5
2
3
4
11
12
14
13
RIGEL344
RIGEL344 UserManual 15
PowerUpandInitialisation
TheRIGEL344 isbatterypowered.ThepowerOn/Off switchislocatedon
thetop righthand sideoftheinstrument.Thefunction selectorDEFIB/
PACERswitchislocatedonthetop lefthand sideoftheinstrument.Whenthe
instrumentisturnedon,thefunction selectedand theversionand revision level
ofthesoftwarearedisplayedforabout5seconds.
2.3.1RS232Setup
TheRigel344 canbeconnectedtoaprinteroraPCviatheRS232CSERIAL
PORTlocatedon thesideoftheinstrument.
Thedefault settingsfortheserialcommunication are:
Baud Rate=9600,DataBits=8,Parity=None,Stop Bit =1
ThesesettingsmustbethesameforthePCorthePrinter.Toretrievethedata
intoaPalmPilotusetheoptionalinterfacecableforthePalmPilot.
2.4Menu Structure
TheRIGEL344 iseasilyoperatedviaamenu systemutilising aneight
keykeypadlocatedon thefrontoftheinstrumentbelowthedisplay.
Menusappearon thedisplayabovethefourkeyslabeled‘F1’, ‘F2’,‘F3’,
and ‘F4’.Thefourlowerkeysarelabeled‘←’, ‘ESC’,‘PRN’and ‘→’.
Theinstrumentisusedby following theinstructionson thedisplayand
pressing theappropriatekey.
The‘ESC’keyhastwodifferentfunctions.Insomemenusit will
changethedisplaytothepreviousmenu,and insomesituationsitconfirms
themenu selection.The‘PRN’keyactivatesanoptionalprinter.The
arrowkeys,‘←’and ‘→’, movethedisplayforwardorbackwardwithina
group ofpossibleselections.
Thefollowingare samplesofmainmenu displays:
DefibrillatorPower UpInitialisationMenu:Displayedfor3
Seconds
R I G E L 3 4 4
D e f i b / S i m V e r 2 . 0 r 6
RIGEL344 UserManual 16
DefibrillatorMainMenu:AutomaticallyDisplayedAfter Power Up
E n e r g y : 0 0 0 0 J o u l e s
P e a k : V
o l t s
P e a k : A
m
p
E - H
I C
A
R D
A
E D
S I M
F1 F2 F3 F4
DefibrillatorMenu:‘F1’KeyPressed=Energy Range=Low
E n e r g y : 0 0 . 0 0 J o u l e s
P e a k : V
o l t s
P e a k : A
m
p
E - L O
C
A
R D
A
E D
S I M
F1 F2 F3 F4
CardioversionTestMenu: ‘F2’KeyPressed=Cardio.Time
C
a r d i o : - 0 0 0 m
S
E n e r g y : 0 0 0 0 J o u l e s
E C
G
: 6 0 b p m
E - H
I C
A
R D
A
E D
S I M
F1 F2 F3 F4
AEDTestMenu:‘F3” KeyPressed=‘AED’inDefibrillatorMenu
E n e r g y : 0 0 0 0 J o u l e s
A
R
R
T
H
E
C
G
F1 F2 F3 F4
SimulatorMenu:‘F4’KeyPressed=SimulatorMenu
S i m
u l a t o r
A
M
P : 1 m
V
E
C
G
: 6 0 b p m
E C
G
A
R
R
T H
P E R
F A
M
P L
F1 F2 F3 F4
RIGEL344 UserManual 17
Pacer TestMenu: FunctionSelectedisPacer
Pacer Power UpInitialisationMenu:Displayedfor3Seconds
R I G
E L 3 4 4
P a c e r V
e r 2 . 0 r 6
Pacer Main Menu:AutomaticallyDisplayedAfter Power Up
S e l e c t P a c e r T
y p e
P r e s s F 1 o r F 4
A
t r i a l V
e n t r i
F1 F2 F3 F4
Pacer TransthoracicMenu:Switchin TRANS.INPUTPosition
X
T h o r a c i c T y p e
S e l e c t
m
a n u f .
<
- P R N
=
H
e a d e r - >
Z O
L L H
P M
D
E L I
F
E
F1 F2 F3 F4
2.5TestingADefibrillator
2.5.1Energy Measurement
TheRIGEL344hashigh andlowenergymeasurementranges.Up
to1000 joulesmaybemeasuredinthehigh rangemodeand up to
100 joulesmaybemeasuredinthelowrangemode.
A. Turnon thedefibrillatortobetestedand selecttheenergy
outputfollowingthemanufacturer’sinstruction manual.
B. TurntheRIGEL344 on and movethefunction selector
switchtotheDEFIBmode.TheDefibrillatorMainMenu,
Figure1,will bedisplayed.
C. TheRIGEL 344 isintheenergy measurementmodeand is
ready tomakeanenergy measurement.
RIGEL344 UserManual 18
D. Tomeasureenergy inthelowrangepress theF1key.‘E-HI’
will changeto‘E-LO’asinFigure2.
E. Tomeasuretheenergy,dischargethedefibrillatorpaddles.
F. Inthelowrange,ifthedischargedenergy exceeds100
joules,thedisplaywill flashHIGH.
Figure 1
DefibrillatorMainMenu
E N
E r g y : 0 0 0 0 J o u l e s
P e a k : V
o l t s
P e a k : A
m
p
E - H
I C
A
R D
A
E D
S I M
F1 F2 F3 F4
Figure 2
DefibrillatorMenu:Energy Range‘E-LO’F1KeyPressed
E N
E r g y : 0 0 . 0 0 J o u l e s
P e a k : V
o l t s
P e a k : A
m
p
E - L O
C
A
R D
A
E D
S I M
F1 F2 F3 F4
2.5.2PeakVoltageand Current
Eachtimethedefibrillatorisdischarged,thedisplaywill updatethe
peakvoltageandthepeakcurrent(displayedinAmps)measurement
readings.
2.5.3ViewingWaveformOutput
2.5.3.1OnaDefibrillatorMonitor
1. Afterthedefibrillatorisdischarged,and whiletheRIGEL 344 is
intheenergy mode,thecapturedwaveformwill beavailable
through theECGleads,thepaddlecontacts,and thehigh level
outputjackon thesidepanel.
2. Waveformson theECGleadsand paddlesareamplitudescaledto
providemaximum output.Timeisscaledtoprovideatime
expansion of1:200.TheDischargedwaveisrepeatedat8-second
intervals.
RIGEL344 UserManual 19
RIGEL344 UserManual 20
2.5.3.2OnanOscilloscope
Anattenuateddefibrillatordischargewaveformcanbedisplayedon
anoscilloscope.Theamplitudereductionis1000:1volts.
A. Connectanoscilloscopetothesidepaneloutputjacklocatedon
the
leftside.
B. Setthesweepto1ms/divand theverticalgainto1volt.
Discharge
thedefibrillatoron thepaddlecontacts,andobservethewaveform
on theoscilloscope.
C.If itisastorageoscilloscope,activatethestoragemodebefore
discharging energytotheRIGEL344.
2.5.4MeasuringCardioversion(Sync.)Time
TheRIGEL 344 measuresthesynchronisation time(cardioversion
time)ofthedefibrillator.AsimulatedECGwaveform@60 BPMis
outputthrough theECGjacksand thepaddlecontactplates.During
normaloperation,thedefibrillatorrecognisesandrespondstothis
triggerbydischarging withinacertainperiod oftime.
TheRIGEL344 iscapableofmeasuring thecardioversion(sync.)
timeifthedefibrillatordischargeenergy iswithin ±250 msofthe
peakoftheRwave.
A. Press‘CARD’softkey(F2)fromtheMainmenu.
B. AsimulatedECGwaveform@60BPMisoutputthrough the
ECGleadsand paddles.
C. Selectthesource oftheECGwaveformon yourdefibrillator.
ObservetheECGcoming outoftheRIGEL 344on your
defibrillatormonitor.
D. Setthedefibrillatortothesynchronize mode.
E. Dischargetheenergyon theRIGEL 344.
F. Thecardiversion (sync.)timewill bedisplayed.
G. If thecardioversiontimeisgreaterthan ±250 msofthepeakof
theRwave,theRIGEL344 willdisplay‘overrange’.
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