Essential Performance; Defibrillation; Transcutaneous Pacing; Ecg Monitoring - ZOLL M2 Operator's Manual

Essential performance

The Essential performance of ZOLL M2 unit has met the requirements of the applicable
standards (IEC60601-1, IEC60601-2-4, IEC60601-2-27, IEC 60601-1-2, IEC 60601-1-6,
IEC 62366, IEC 60601-1-8).

Defibrillation

Energy output accuracy, charge time, synchronized cardioversion, sync delay, AED rhythm
recognition.

Transcutaneous Pacing

Pacing pulse shape, pulse duration and stability, pulse current, pulse rate and stability.

ECG Monitoring

Input impedance, frequency response, bandwidth, common mode rejection, linearity, dynamic
range, noise, channel crosstalk, gain control, sweep speed, baseline reset, pacemaker pulse
display capability, QRS detection range, aspect ratio, tall T-wave rejection, heart rate accuracy,
low and high heart rate alarms.
SpO Monitoring
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SpO measurement accuracy, pulse rate accuracy, low and high alarms for SpO
2

CPR Feedback

Accuracy of compression depth measurement, visual and audible CPR feedback, proper
metronome rate.

Overload Protection

Defibrillation protection, defibrillation energy reduction, electrosurgery protection.

Performance on AC Power

For power interruptions of 30 seconds or less: no change of operator settings shall occur,
including the mode of operation, and all stored patient data shall remain available.
For power interruptions longer than 30 seconds, the subsequent operation shall be one of the
following: reversion to the manufacturer's default settings, reversion to the supervisor's default
settings.
If a battery is installed when mains power is interrupted, the monitor shall automatically switch
to battery power, with no change in mode of operation, operator settings, or stored data. There
shall be a visual indication that the monitor is operating on battery power.

Performance on Battery Power

Battery capacity, battery shelf life, low battery indication, low battery shutdown.
9650-000860-01 Rev. C ZOLL M2 Operator's Guide

Essential performance

, and pulse rate.
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A-11