ZOLL M2 Manual

ZOLL M2™Operator’s Guide
9650-000860-01 Rev. C

The issue date for the ZOLL M2 Operator's Guide (REF 9650- 000860-01 Rev. C) is September, 2019.
Copyright © 2019 ZOLL Medical Corporation. All rights reserved. CPR-D-padz, Pedi-padz, R Series,
Real CPR Help, Rectilinear Biphasic, RescueNet, Stat-padz, SurePower, X Series, ZOLL, and ZOLL M2 are
trademarks or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries.
All other trademarks are the property of their respective owners.
Suzhou ZOLL Medical Technology Co., Ltd.
Room 102-2, Block 19, No.8 Jinfeng Road
Suzhou New District, 215163 Suzhou
Jiangsu, P.R. China
Manufactured for:
ZOLL Medical Corporation
269 Mill Road
Chelmsford, MA USA
01824-4105
TEL: [phone]
FAX: [phone]
WEB: www.zoll.com
EMAIL: [email protected]
ZOLL International Holding B.V.
Newtonweg 18
6662 PV ELST
The Netherlands
0123

9650-000860-01 Rev. C ZOLL M2 Operator’s Guide i
Table of Contents
Chapter 1 General Information
Product Description ............................................................................................................1-1
Contraindications ........................................................................................................ 1-2
How to Use This Manual..................................................................................................... 1-2
Operator’s Guide Updates .................................................................................................. 1-3
Unpacking........................................................................................................................... 1-3
Starting up the ZOLL M2..................................................................................................... 1-3
Symbols Used on the Equipment ....................................................................................... 1-4
ZOLL M2 Indications for Use .............................................................................................. 1-8
Manual Defibrillation ................................................................................................... 1-8
Semiautomatic Operation (AED) ................................................................................ 1-9
ECG Monitoring .......................................................................................................... 1-9
CPR Monitoring .......................................................................................................... 1-9
External Transcutaneous Pacing ................................................................................ 1-9
SpO2 Monitoring ....................................................................................................... 1-10
ZOLL M2 Product Functions ............................................................................................. 1-10
Defibrillator Function ................................................................................................. 1-10
Defibrillator Output Energy ....................................................................................... 1-10
External Pacemaker ................................................................................................. 1-10
ECG Monitoring ........................................................................................................ 1-11
Electrodes ................................................................................................................. 1-11
Batteries .................................................................................................................... 1-11
Safety Considerations....................................................................................................... 1-12
Warnings........................................................................................................................... 1-13
General ..................................................................................................................... 1-13
ECG Monitoring ........................................................................................................ 1-14
Defibrillation .............................................................................................................. 1-15
Pacing ....................................................................................................................... 1-16
CPR .......................................................................................................................... 1-17
SpO2 ......................................................................................................................... 1-17
Ferromagnetic Equipment ........................................................................................ 1-17
Battery ...................................................................................................................... 1-17
Operator Safety ........................................................................................................ 1-18
Patient Safety ........................................................................................................... 1-19
Cautions............................................................................................................................ 1-20
Restarting the Monitor/Defibrillator ................................................................................... 1-20
Software License .............................................................................................................. 1-21
Service.............................................................................................................................. 1-21
The ZOLL Serial Number.................................................................................................. 1-22

TABLE OF CONTENTS
ii www.zoll.com 9650-000860-01 Rev. C
Chapter 2 Product Overview
Overview............................................................................................................................. 2-1
Controls and Indicators....................................................................................................... 2-2
The Front Panel .......................................................................................................... 2-3
Display Screen ............................................................................................................ 2-5
Battery Status and AC Power Indicators .................................................................... 2-6
Patient Cables and Connectors .................................................................................. 2-7
External Paddles ....................................................................................................... 2-10
Navigating the Display Screen.......................................................................................... 2-13
Quick Access Keys ................................................................................................... 2-13
Trim Knob ................................................................................................................. 2-15
Display Brightness .................................................................................................... 2-15
Using Code Markers ................................................................................................. 2-16
Replacing a Battery Pack on the ZOLL M2 Unit ............................................................... 2-16
Chapter 3 Monitoring Overview
ZOLL M2 Monitoring Functions........................................................................................... 3-1
ECG ............................................................................................................................ 3-2
Heart Rate .................................................................................................................. 3-2
Selecting the Waveform Display ......................................................................................... 3-2
Inserting, Removing, or Replacing a Waveform Trace ............................................... 3-3
Chapter 4 Trends
Displaying the Patient Trend Data Window ........................................................................ 4-1
Viewing the Patient Trend Data window ..................................................................... 4-2
Printing Trend Information .................................................................................................. 4-3
To Print Incidents ........................................................................................................ 4-3
Chapter 5 Alarms
Alarm Indicator Self-Test..................................................................................................... 5-2
Patient Alarm Display..........................................................................................................5-2
Equipment Alert Display...................................................................................................... 5-3
Visual and Audible Alarm Indicators.................................................................................... 5-4
Responding to Active Patient Alarms.................................................................................. 5-5
Silencing Patient Alarms ............................................................................................. 5-5
Disabling Patient Alarms ............................................................................................. 5-6
Alarm Reminders ........................................................................................................ 5-6
Latching Alarms .......................................................................................................... 5-6
Responding to Equipment Alarms ...................................................................................... 5-7
Setting Alarm Limits ............................................................................................................ 5-7

TABLE OF CONTENTS
9650-000860-01 Rev. C ZOLL M2 Operator’s Guide iii
Chapter 6 Monitoring ECG
ECG Monitoring Setup........................................................................................................ 6-3
Preparing the Patient for Electrode Application .......................................................... 6-3
Applying Electrodes to the Patient .............................................................................. 6-4
Connecting the ECG Cable To the ZOLL M2 Unit ...................................................... 6-6
Selecting Patient Type ................................................................................................ 6-6
Selecting ECG Waveforms for Display ....................................................................... 6-7
Selecting the Waveform Trace Size ........................................................................... 6-8
Diagnostic ECG .......................................................................................................... 6-9
ECG Monitoring and Implanted Pacemakers ............................................................. 6-9
Accessing the ECG Setting Window................................................................................. 6-10
Heart Rate Meter .............................................................................................................. 6-11
Configuring Heart Rate (HR) Meter Alarms ...................................................................... 6-11
Enabling/Disabling HR Alarms and Setting Alarm Limits .......................................... 6-12
Check Patient Alarm ................................................................................................. 6-12
ECG System Messages.................................................................................................... 6-13
Chapter 7 Monitoring SpO2
Cautions.............................................................................................................................. 7-3
SpO2 Setup and Use.......................................................................................................... 7-4
Selecting the SpO2 Sensor ................................................................................................ 7-4
Applying the SpO2 Sensor ................................................................................................. 7-4
Connecting the SpO2 Sensor ............................................................................................. 7-5
Displaying SpO2 Measurements ........................................................................................ 7-5
Adjustable SpO2 Settings................................................................................................... 7-6
Setting the Sensitivity Level ........................................................................................ 7-6
Adjusting the Plethysmogram Display ........................................................................ 7-7
Enabling/Disabling SpO2 Alarms and Setting Alarm Limits ........................................ 7-8
SpO2 System Messages .................................................................................................... 7-9
Chapter 8 Automated External Defibrillator (AED) Operation
Modes of Operation .................................................................................................... 8-1
Patient Type ................................................................................................................ 8-2
Determine Patient Condition Following Medical Protocols ......................................... 8-3
Begin CPR Following Medical Protocols .................................................................... 8-3
Prepare Patient ........................................................................................................... 8-3
Turn on Unit ................................................................................................................ 8-4
Set Patient Type ......................................................................................................... 8-5
1 Analyze .................................................................................................................... 8-5
3 Press SHOCK .......................................................................................................... 8-8
Perform CPR .............................................................................................................. 8-8
CPR Dashboard .......................................................................................................... 8-9
Operating Messages ................................................................................................. 8-10
Audio and Display Messages ................................................................................... 8-10
Switching to Manual Mode Operation............................................................................... 8-12

TABLE OF CONTENTS
iv www.zoll.com 9650-000860-01 Rev. C
Chapter 9 Manual Defibrillation
Emergency Defibrillation Procedure with Paddles.............................................................. 9-1
Modes of Operation .................................................................................................... 9-2
Patient Type ................................................................................................................ 9-2
Determine the Patient’s Condition Following Local Medical Protocols ....................... 9-2
Begin CPR Following Local Medical Protocols ........................................................... 9-2
Prepare Patient ........................................................................................................... 9-2
Turn on Unit ................................................................................................................ 9-3
Set Patient Type ......................................................................................................... 9-3
1 Select Energy Level ................................................................................................. 9-3
2 Charge Defibrillator .................................................................................................. 9-5
3 Deliver Shock ........................................................................................................... 9-7
Emergency Defibrillation Procedure with Hands-Free Therapy Electrodes........................ 9-8
Determine the Patient’s Condition Following Local Medical Protocols ....................... 9-8
Begin CPR Following Medical Protocols .................................................................... 9-8
Prepare Patient ........................................................................................................... 9-8
Turn on Unit ................................................................................................................ 9-9
Set Patient Type ......................................................................................................... 9-9
1 Select Energy Level ............................................................................................... 9-10
2 Charge Defibrillator ................................................................................................ 9-11
3 Deliver Shock ......................................................................................................... 9-12
Synchronized Cardioversion............................................................................................. 9-14
Synchronized Cardioversion of Atrial Fibrillation ...................................................... 9-15
Synchronized Cardioversion Procedure ........................................................................... 9-15
Determine the Patient’s Condition and Provide Care Following Local Medical
Protocols ................................................................................................................ 9-15
Prepare Patient ......................................................................................................... 9-15
Turn on Unit .............................................................................................................. 9-16
Set Patient Type ....................................................................................................... 9-16
1 Select Energy Level ............................................................................................... 9-17
2 Charge Defibrillator ................................................................................................ 9-17
3 Deliver Shock ......................................................................................................... 9-18
Internal Paddles................................................................................................................ 9-18
Verification Prior to Use ............................................................................................ 9-19
Chapter 10 Real CPR Help
CPR User Interface........................................................................................................... 10-2
CPR Dashboard ........................................................................................................ 10-2
CPR Rate Metronome .............................................................................................. 10-3
CPR Compression Voice Prompts (Adult Patients Only) .......................................... 10-3
CPR Compression Bar Graph .................................................................................. 10-4

TABLE OF CONTENTS
9650-000860-01 Rev. C ZOLL M2 Operator’s Guide v
Chapter 11 External Pacing
External Pacing................................................................................................................. 11-2
Pacer Modes ............................................................................................................. 11-2
Pacing in Demand Mode .................................................................................................. 11-2
Prepare the Patient ................................................................................................... 11-2
1 Apply ECG Electrodes ........................................................................................... 11-3
2 Apply Hands-Free Therapy Electrodes .................................................................. 11-3
3 Turn Mode Selector to PACER .............................................................................. 11-4
4 Set Pacer Mode ..................................................................................................... 11-4
5 Set Pacer Rate ...................................................................................................... 11-4
6 Start Pacer ............................................................................................................. 11-5
7 Set Pacer Output ................................................................................................... 11-5
8 Determine Capture ................................................................................................ 11-5
9 Determine Optimum Threshold .............................................................................. 11-6
Pacing in Fixed Mode ....................................................................................................... 11-6
Determine Patient Condition and Provide Care Following Local Medical Protocols . 11-6
Prepare the Patient ................................................................................................... 11-6
1 Apply ECG Electrodes ........................................................................................... 11-6
2 Apply Hands-Free Therapy Electrodes .................................................................. 11-7
3 Turn Mode Selector to PACER .............................................................................. 11-7
4 Set Pacer Mode ..................................................................................................... 11-8
5 Set Pacer Rate ...................................................................................................... 11-8
6 Start Pacer ............................................................................................................. 11-8
7 Set Pacer Output ................................................................................................... 11-8
8 Determine Capture ................................................................................................ 11-9
9 Determine Optimum Threshold .............................................................................. 11-9
Pediatric Pacing ...................................................................................................... 11-10
Pacing Messages ........................................................................................................... 11-10
Chapter 12 Incident Data and Reports
Data Storage..................................................................................................................... 12-2
Summary Report............................................................................................................... 12-2
Printing Summary Report ......................................................................................... 12-3
Event Log.......................................................................................................................... 12-4
Snapshots......................................................................................................................... 12-6
Snapshot Types ........................................................................................................ 12-7
Printing Snapshots .................................................................................................. 12-12
Full Disclosure Recording............................................................................................... 12-13
Transferring Full Disclosure Recording Using USB ................................................ 12-13
Transferring Full Disclosure Recording Using WiFi ................................................ 12-15
Deleting a Rescue Incident............................................................................................. 12-16
Setting Up a Wireless Configuration/SFTP Server ......................................................... 12-17
To Set Up A Wireless Configuration ....................................................................... 12-17
To Set Up An SFTP Server .................................................................................... 12-19

TABLE OF CONTENTS
vi www.zoll.com 9650-000860-01 Rev. C
Chapter 13 Maintenance and Troubleshooting
Daily/Shift Check Procedure............................................................................................. 13-2
Inspection ................................................................................................................. 13-2
Defibrillator/Pacing Test .................................................................................................... 13-3
Defibrillator Testing with External Paddles........................................................................ 13-5
SpO2 Functional Check.................................................................................................... 13-6
Recommended Minimum Preventive Maintenance Schedule .......................................... 13-7
Guidelines for Maintaining Peak Battery Performance ..................................................... 13-7
Cleaning instructions ........................................................................................................ 13-8
Cleaning the ZOLL M2 unit ....................................................................................... 13-8
Cleaning SpO2 Sensors ........................................................................................... 13-8
Cleaning Cables and other Accessories ................................................................... 13-8
Cleaning the Print Head ............................................................................................ 13-9
Loading Recorder Paper ........................................................................................... 13-9
Troubleshooting .............................................................................................................. 13-11
Appendix A Specifications
Defibrillator..........................................................................................................................A-2
Display ................................................................................................................................A-2
ECG ....................................................................................................................................A-2
Pulse Oximetry (SpO2).......................................................................................................A-4
Alarms.................................................................................................................................A-5
Recorder .............................................................................................................................A-6
Battery ................................................................................................................................A-7
General ...............................................................................................................................A-7
Pacer ..................................................................................................................................A-8
Chest Compression Monitoring ..........................................................................................A-8
WiFi.....................................................................................................................................A-8
Essential performance ...................................................................................................... A-11
Defibrillation ..............................................................................................................A-11
Transcutaneous Pacing ............................................................................................A-11
ECG Monitoring ........................................................................................................A-11
SpO2 Monitoring .......................................................................................................A-11
CPR Feedback .........................................................................................................A-11
Overload Protection ..................................................................................................A-11
Performance on AC Power .......................................................................................A-11
Performance on Battery Power .................................................................................A-11
Electromagnetic Compatibility (EMC) .......................................................................A-12
ZOLL M2 Rectilinear Biphasic Waveform Characteristics ................................................A-13
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
Electromagnetic Compatibility Guidance and Manufacturer’s Declaration .......................A-28

TABLE OF CONTENTS
9650-000860-01 Rev. C ZOLL M2 Operator’s Guide vii
Electromagnetic Immunity (IEC 60601-1-2) ..............................................................A-29
Electromagnetic Immunity: Professional Healthcare Facility and Home Healthcare
Environments .........................................................................................................A-30
Electromagnetic Immunity: Professional Healthcare Facility and Home Healthcare
Environments .........................................................................................................A-31
ECG Analysis Algorithm Accuracy ....................................................................................A-32
Clinical Performance Results ....................................................................................A-32
Wireless Output Guidance and Manufacturer’s Declaration.............................................A-34
RF Transmission Emitted (IEC 60601-1-2) ...............................................................A-34
Appendix B Accessories
Appendix C Messages

TABLE OF CONTENTS
viii www.zoll.com 9650-000860-01 Rev. C