TABLE OF CONTENTS
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Appendix A Specifications
Defibrillator..........................................................................................................................A-2
Monitor/Display .................................................................................................................A-14
Impedance Pneumography...............................................................................................A-15
Alarms...............................................................................................................................A-16
Recorder ...........................................................................................................................A-17
Battery ..............................................................................................................................A-17
General .............................................................................................................................A-18
Pacer ................................................................................................................................A-19
CO2 ..................................................................................................................................A-19
Pulse Oximeter .................................................................................................................A-20
Non-Invasive Blood Pressure ...........................................................................................A-23
Invasive Pressures ...........................................................................................................A-24
Temperature......................................................................................................................A-25
Clinical Trial Results for the Biphasic Waveform ..............................................................A-26
Randomized Multicenter Clinical Trial for Defibrillation of Ventricular Fibrillation (VF)
and Ventricular Tachycardia (VT) ...........................................................................A-26
Randomized Multi-Center Clinical trial for Cardioversion of
Atrial Fibrillation (AF) ..............................................................................................A-27
Synchronized Cardioversion of Atrial Fibrillation ......................................................A-29
Electromagnetic Compatibility Guidance and Manufacturer’s Declaration .......................A-30
Electromagnetic Immunity (IEC 60601-1-2) ..............................................................A-31
Electromagnetic Immunity: Life-Supporting Functions .............................................A-32
Electromagnetic Immunity: Non Life-Supporting Functions ......................................A-33
ECG Analysis Algorithm Accuracy ....................................................................................A-36
Clinical Performance Results ....................................................................................A-36
Wireless Output Guidance and Manufacturer’s Declaration.............................................A-37
RF Transmission Emitted (IEC 60601-1-2) ...............................................................A-37
FCC Notice ...............................................................................................................A-37
Canada, Industry Canada (IC) Notices .....................................................................A-37
Appendix B Accessories
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