ZOLL M Series Defibrillator Rev YH User Manual
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Table of Contents
Section 1 General Information
Product Description ............................................................................................................ 1-1
How to Use This Manual..................................................................................................... 1-2
Manual Updates.................................................................................................................. 1-2
Unpacking ........................................................................................................................... 1-2
Accessories ........................................................................................................................ 1-2
Symbols Used on the Equipment ....................................................................................... 1-3
Defibrillator Function ........................................................................................................... 1-4
Intended Use — Manual Operation ............................................................................ 1-4
Intended Use — Semiautomatic Operation (AED) ..................................................... 1-4
Intended Use — CPR Monitoring ............................................................................... 1-4
Semiautomatic Operation Contraindications for Use .................................................. 1-4
Defibrillator Complications .......................................................................................... 1-4
Defibrillator Output Energy ......................................................................................... 1-4
External Pacemaker (Pacer Version Only) ......................................................................... 1-5
Intended Use — Pacemaker ....................................................................................... 1-5
Pacemaker Complications .......................................................................................... 1-5
Pediatric Pacing .......................................................................................................... 1-6
Monitor ................................................................................................................................ 1-6
Recorder Function .............................................................................................................. 1-6
Paddle — Electrode Options .............................................................................................. 1-6
Batteries.............................................................................................................................. 1-6
Internal Battery Charger ..................................................................................................... 1-6
External Battery Charger .................................................................................................... 1-7
Diagnostics ......................................................................................................................... 1-7
Safety Considerations......................................................................................................... 1-8
WARNINGS ................................................................................................................ 1-8
CAUTIONS ............................................................................................................... 1-10
Restarting the Device........................................................................................................ 1-10
FDA Regulations............................................................................................................... 1-11
Tracking Requirements ............................................................................................. 1-11
Notification of Adverse Events .................................................................................. 1-11
Warranty (U.S. Only)......................................................................................................... 1-11
Software License .............................................................................................................. 1-12
Service .............................................................................................................................. 1-12
U.S.A. Customers ..................................................................................................... 1-12
International Customers ............................................................................................ 1-12
Defibrillator Waveform Information ................................................................................... 1-13
ECG Analysis Algorithm Accuracy.................................................................................... 1-14
Clinical Performance Results .................................................................................... 1-14