AED 10 User Manual - Welch Allyn

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82 Specifications Welch Allyn AED 10 Automated External DefibrillatorSummary of studies of waveform safety and effectivenessIntroductionStudy 1ObjectiveMethodsOver 30 years ago, Medical Research Laboratories (MRL) patented a unique monophasictruncated exponential waveform, which utilized a low peak current, impedancecompensated defibrillation waveform. The MRL monophasic waveform was developed asan alternative to the monophasic damped sine (MDS) waveform (often referred to as theEdmark waveform) defibrillator, which was associated with higher peak currents and didnot actively compensate for varying patient impedances. In fact, the MRL monophasicwaveform defibrillator delivers less than half of the peak current of an MDS waveformdefibrillator at equal delivered energies. A new defibrillator (the Welch Allyn AED 10) hasbeen introduced, which offers a biphasic truncated exponential waveform thatincorporates MRL's original low peak current, impedance compensation design. The MRLOrbital biphasic truncated exponential waveform has been extensively tested in multiplescientific safety and effectiveness studies. Over 524 fibrillation/defibrillation shockepisodes have been conducted using the MRL Orbital Biphasic waveform comparing it toMDS, MTS and another commercially available 2kV biphasic (360 J capable) defibrillators.Results of three of the scientific safety and effectiveness studies are summarized below.To evaluate the MRL Orbital Biphasic waveform defibrillator against a monophasicdamped sinusoidal waveform defibrillator.A canine model (n=5, 71±7 lbs) was used in a study that was approved by the InstitutionalAnimal Care and Use Committee. The animals were anesthetized with 20 mpk sodiumpentothal i.v., and maintained as required through an intravenous catheter in the foreleg.The external jugular vein was cannulated and a bipolar pacing catheter was introducedunder fluoroscopic control and advanced into the right ventricle. The femoral artery wascannulated and an intra-arterial line was placed for continuous measurement of arterialblood pressure. The chest was shaved and defibrillating patch electrodes (R2 part number3200-1715) were placed on the left and right chest walls.Fibrillation was induced by delivering 60 Hz current to the right ventricular electrode. Theenergy required to defibrillate was determined by a protocol that has been used in severalother biphasic comparison studies. An initial shock strength of 50 to 70 joules was used. Ifsuccessful, VF is reinduced after a 4-minute rest period, and the shock strength isreduced by approximately 20% for the next defibrillation attempt. If the initial shock fails, arescue shock is delivered, and after a rest period, VF is again induced. The energy is nowincreased about 20% for the next defibrillation attempt. This procedure was continueduntil at least 3 reversals in result were observed with each waveform. Two ED50estimation procedures were run in parallel, with the device being used alternated on eachshock. In practice, actual clinical units were used, so the energy steps were limited tothose selectable on the devices tested.
User Manual Specifications 83ResultsThe study consisted of 82 total fibrillation/defibrillation episodes. ID50 peak currents andED50 delivered energies are shown below for each group. The mean impedance for theseanimals was 62 . The mean ED50 energies were compared and were found to besignificantly different. The significance of difference (p-value) was calculated by the Waldtest in each case, and is shown below. The mean ED50 peak current for the biphasicwaveform was 39 percent of that required with the MDS waveform.Summary table — ED50 and ID50MeanWelch AllynAED 10MonophasicDamped SineID50 Peak Current (Amps) 6.4 16.6Significance of difference (p-value)
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AED 10 TMAutomated External Defibri
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iiiContentsPreface ................
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vPrefaceImportant!Read this Operato
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User Manual Preface viiIndemnificat
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11SafetyConventions used in the man
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User Manual Safety 3Patient safetyG
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User Manual Safety 5Defibrillator a
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User Manual Safety 7Battery careaCa
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User Manual Safety 9Safety symbolsG
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112IntroductionThis chapter provide
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User Manual Introduction 13Getting
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User Manual Introduction 15Installi
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User Manual Introduction 17Getting
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User Manual Introduction 19DisplayT
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User Manual Introduction 21Stand cl
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User Manual Introduction 23Preparin
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253Using the defibrillatorThis chap
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User Manual Using the defibrillator
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User Manual Using the defibrillator
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Page 47 and 48: 394ProgrammingThis chapter explains
Page 49 and 50: User Manual Programming 41Main Menu
Page 51 and 52: User Manual Programming 43Adjusting
Page 53 and 54: User Manual Programming 45Transmitt
Page 55 and 56: User Manual Programming 47Superviso
Page 57 and 58: User Manual Programming 49Superviso
Page 59 and 60: User Manual Programming 51Selecting
Page 61 and 62: User Manual Programming 53Setting t
Page 63 and 64: User Manual Programming 55Setting t
Page 65 and 66: User Manual Programming 57Utility M
Page 67 and 68: 595MaintenanceThis section contains
Page 69 and 70: User Manual Maintenance 61The user
Page 71 and 72: User Manual Maintenance 63Checklist
Page 73 and 74: User Manual Maintenance 65Inspectin
Page 75 and 76: User Manual Maintenance 67Recycling
Page 77 and 78: 696TroubleshootingOverviewThis chap
Page 79 and 80: User Manual Troubleshooting 71Defib
Page 81 and 82: 73ASpecificationsPhysical .........
Page 83 and 84: User Manual Specifications 75Defibr
Page 85 and 86: User Manual Specifications 77Electr
Page 87 and 88: User Manual Specifications 79Guidan
Page 89: User Manual Specifications 81Rhythm
Page 93 and 94: User Manual Specifications 85Study
Page 95 and 96: 87BGlossaryAEDAHAALSautomated exter
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