Appendix b accessories – ZOLL X Series Monitor Defibrillator Rev H User Manual
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Temperature......................................................................................................................A-24
Clinical Trial Results for the Biphasic Waveform ..............................................................A-25
Randomized Multicenter Clinical Trial for Defibrillation of Ventricular Fibrillation (VF)
and Ventricular Tachycardia (VT) ...........................................................................A-25
Randomized Multi-Center Clinical trial for Cardioversion of Atrial Fibrillation (AF) ...A-26
Synchronized Cardioversion of Atrial Fibrillation ......................................................A-28
Electromagnetic Compatibility Guidance and Manufacturer’s Declaration .......................A-29
Electromagnetic Immunity (IEC 60601-1-2) ..............................................................A-30
Electromagnetic Immunity: Life-Supporting Functions .............................................A-31
Electromagnetic Immunity: Non Life-Supporting Functions ......................................A-32
ECG Analysis Algorithm Accuracy....................................................................................A-35
Clinical Performance Results ....................................................................................A-35
Wireless Output Guidance and Manufacturer’s Declaration.............................................A-36
RF Transmission Emitted (IEC 60601-1-2) ...............................................................A-36
FCC Notice ...............................................................................................................A-36
Canada, Industry Canada (IC) Notices .....................................................................A-36
Appendix B
Accessories