X Series Operators Guide Advanced Rev D

The issue date for the X Series Advanced Operator's Guide (REF 9650-005355-05 Rev. D) is Oct. 2021. Copyright © 2021 ZOLL Medical Corporation. All rights reserved. AccuVent, AED Pro, AED Plus, AutoPulse, CPR-D-padz, OneStep, Pedi-padz, Perfusion Performance Indicator, RapidShock, Real BVM Help, Real CPR Help, Rectilinear Biphasic, RescueNet, ResQCPR, See-Thru CPR, Stat-padz, SurePower, X Series Advanced, and ZOLL 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. Masimo, Rainbow, SET, SpCO, SpMet, SpHb, SpOC, and PVI are trademarks or registered trademarks of Masimo Corporation in the United States and/or other countries. Propaq is a registered trademark of Welch Allyn Inc. Oridion Microstream FilterLine® and Smart CapnoLine® are registered trademarks of Medtronic plc. This product and accompanying components are manufactured and sold under one or more patents listed at the following internet address: http://www.zoll.com/patents

ZOLL Medical Corporation 269 Mill Road Chelmsford, MA USA 01824-4105 ZOLL International Holding B.V. Newtonweg 18 6662 PV ELST The Netherlands

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Indications for Use Defibrillator Function The X Series Advanced system is indicated for defibrillation on victims of cardiac arrest where there is apparent lack of circulation as indicated by: • Unconsciousness. • Absence of breathing. • Absence of pulse.

The X Series Advanced system in the Manual mode is indicated for synchronized cardioversion of certain atrial or ventricular arrhythmias. A qualified physician must decide when synchronized cardioversion is appropriate. The X Series Advanced system Semiautomatic and Manual mode is indicated for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol. The X Series Advanced system Semiautomatic and Manual mode is indicated for adult and pediatric patients.

Electrocardiogram (ECG) Monitoring The X Series Advanced system is indicated to monitor and/or record 3-, 5-, or 12-lead electrocardiogram (ECG) waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator. ECG monitoring is indicated for patients from newborn (neonate) to adult, with and without heart dysfunction.

CPR Monitoring The X Series Advanced system is indicated to provide visual and audio feedback via the CPR Monitoring function, designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended depth and rate of 2 inches (5 cm) and 100 compressions per minute.

External Transcutaneous Pacing The X Series Advanced is indicated for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. External Pacing is indicated for pediatric and adult patients.

Non-Invasive Blood Pressure Monitoring The X Series Advanced system is indicated for use to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user. The non-invasive blood pressure monitoring feature is indicated for patients from newborn (neonate) to adult.

Temperature Monitoring The X Series Advanced system is indicated for use to make continuous temperature measurements of rectal, esophageal, or surface temperatures, and to alarm if the temperature is outside of the limits set by the user. The temperature monitoring feature is indicated for use in patients from newborn (neonate) to adult.

SpO2 Monitoring The X Series Advanced system is indicated for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and/or carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), pleth variability index (PVI), and perfusion index (PI) via the pulse Co-oximeter and accessories. The pulse Co-oximeter and accessories are indicated for use on adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, or in mobile environments.

Respiration Monitoring The X Series Advanced system is indicated for use to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator. Because the measurement method actually measures respiratory effort, apnea episodes with continued respiratory effort (such as obstructive apnea) may not be detected. It is not intended to be used as an apnea monitor. The respiration monitoring feature is indicated for use on patients from newborn (neonate) to adult.

CO2 Monitoring The X Series Advanced system is indicated for use in continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and breath rate. The CO2 monitoring feature is indicated for use on patients from newborn (neonate) to adult.

Invasive Pressure Monitoring The X Series Advanced system is indicated for use to display and make continuous invasive pressure measurements via a compatible pressure transducer. The invasive pressure monitoring feature is indicated for use on patients from newborn (neonate) to adult.

Ventilation Feedback The Ventilation Feedback function is intended for use to make noninvasive measurements of ventilation rate and inspired volumes of manually delivered breaths. The Ventilation Feedback function is intended for use in Adult patients only.

12-Lead Analysis The X Series Advanced system is indicated for use in acquiring, analyzing and reporting physiological data via 12-lead ECG Analysis, and to provide interpretation of the data for consideration by caregivers. The 12-lead ECG Analysis feature is indicated for use on adults (> 18 years of age).

TBI Dashboard The X Series Advanced system is indicated to provide graphical trend data for SpO2, Systolic BP (SBP) and EtCO2 as well as ventilation assistance relevant to the management of a TBI patient.

Web Console The X Series Advanced system is indicated for the remote display of physiological data displayed on connected X Series Advanced systems via the Web Console feature, including electrocardiogram (ECG), non-invasive blood pressure (NIBP), temperature, and heart rate.

RescueNet® Live The X Series Advanced RescueNet® Live Web application is intended for use by trained medical personnel familiar with basic monitoring, vital sign assessment, and emergency cardiac care in order to remotely view near real-time patient and device data transmitted from connected X Series Advanced devices. It requires a clinician at the patient’s side next to the X Series Advanced device. The information streamed to the Web application helps the remote clinician make decisions on patient care supplemental to the clinician on site with the patient. Caution

The remote clinician should not use RescueNet Live as a primary diagnostic device, but instead use the data to consult with the clinician at the patient side.

Contraindications Semiautomatic Operation Contraindications for Use The rhythm analysis function may not reliably identify ventricular fibrillation in the presence of an implanted pacemaker. Inspection of the electrocardiogram and clinical evidence of cardiopulmonary arrest should be the basis for any treatment of patients with implanted pacemakers. Do not use the rhythm analysis function during patient movement on a stretcher. A patient must be motionless during ECG analysis. Do not touch the patient during analysis. Cease all movement of the stretcher prior to analyzing the ECG.

General Information Federal (U.S.A.) law restricts this defibrillator to sale by or on the order of a physician.

TABLE OF CONTENTS

Table of Contents Chapter 1

General Information

Product Description ... 1-1 X Series Advanced Optional Features ... 1-3 How to Use This Manual... 1-3 Operator’s Guide Updates ... 1-3 Unpacking ... 1-4 Symbols Used on the Equipment ... 1-4 Conventions ... 1-8 Intended Use ... 1-9 X Series Advanced Product Functions ... 1-10 Defibrillator Function ... 1-10 Defibrillator Output Energy ... 1-10 External Pacemaker ... 1-10 ECG Monitoring ... 1-10 Electrodes ... 1-11 Batteries ... 1-12 Ready For Use (RFU) Indicator ... 1-13 Safety Considerations... 1-14 Warnings... 1-14 General ... 1-14 ECG Monitoring ... 1-16 Defibrillation ... 1-17 Pacing ... 1-18 CPR ... 1-19 Pulse Oximeter ... 1-19 Noninvasive Blood Pressure ... 1-19 IBP ... 1-20 AccuVent Sensor ... 1-20 TBI Dashboard ... 1-20 CO2 ... 1-20 Respiration ... 1-21 Ferromagnetic Equipment ... 1-21 Battery ... 1-21 Operator Safety ... 1-21 Patient Safety ... 1-22 Cautions... 1-24 Restarting the Defibrillator ... 1-24 FDA Tracking Requirements ... 1-25 Notification of Adverse Events ... 1-26 Software License ... 1-26 Service... 1-26 The ZOLL Serial Number... 1-28

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Chapter 2

Product Overview

Defibrillator Controls and Indicators... 2-1 The Front Panel ... 2-2 Display Screen ... 2-5 Battery Status and Auxiliary Power Indicators ... 2-6 Patient Cables and Connectors ... 2-7 AutoPulse with Shock Sync™ ... 2-10 External Paddles ... 2-10 AC Auxiliary Power Adapter ... 2-14 DC Auxiliary Power Supply (optional) ... 2-15 Connecting the DC Auxiliary Power Supply to a Suitable Vehicle Power Source ... 2-15 Connecting AC Auxiliary Power Adapter or DC Auxiliary Power Supply ... 2-16 Navigating the Display Screen... 2-16 Quick Access Keys ... 2-16 Navigation Keys ... 2-20 Display Brightness ... 2-20 Common Tasks ... 2-20 Setting the Date and Time ... 2-20 Changing the Display Brightness ... 2-22 Replacing a Battery Pack on the X Series Advanced ... 2-22 Using Treatment Buttons ... 2-23

Chapter 3

Monitoring Overview

X Series Advanced Monitoring Functions ... 3-1 ECG ... 3-1 Heart Rate ... 3-2 Respiration Rate ... 3-2 Temperature ... 3-2 Invasive Pressures (IBP) ... 3-2 Non-Invasive Blood Pressure (NIBP) ... 3-2 Capnography (CO2) ... 3-3 Pulse Oximetry (SpO2) ... 3-3 Monitoring Display Options ... 3-4 Configuring the Waveform Display ... 3-7

Chapter 4

Trends

Displaying the Trends Status Window ... 4-2 Printing Trend Information ... 4-3 Printing Trend Summary of All Trends ... 4-3 Printing an Individual Trend Snapshot ... 4-3 Printing The 10 Most Recent Trend Snapshots ... 4-3 Printing Specific Trend Snapshots ... 4-3 Changing the Trends Status Window Display... 4-4 Continuous Waveform Recording ... 4-5

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Chapter 5

Alarms

Visual Alarm Indicators ... 5-2 Audible Alarm Indicators ... 5-2 Alarm Indicator Self-Test... 5-2 Patient Alarm Display... 5-3 Life Threatening Rhythm Alarms... 5-4 Equipment Alert Display... 5-4 Responding to Active Alarms ... 5-5 Re-enabling an Alarm ... 5-5 Latching Alarms ... 5-5 Pausing (Suspending) Alarms ... 5-6 Alarm Reminders ... 5-6 Alarm Options ... 5-7 Selecting Default Alarm Limits ... 5-8 Setting Alarm Limits Relative to the Patient -- Stat Set Option ... 5-8

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 X Series Unit ... 6-6 Selecting ECG Waveforms for Display ... 6-6 Selecting the Waveform Trace Size ... 6-9 ECG Monitoring and Pacemakers ... 6-10 ECG System Messages... 6-11 ECG Lead Fault Identification ... 6-12

Chapter 7

Monitoring Respiration (Resp) and Heart Rate (HR)

Respiration/Breath Rate Meter ... 7-1 Using Impedance Pneumography to Measure Respiration ... 7-2 Configuring Respiration (RR/BR) Alarms and Settings... 7-3 Enabling/Disabling RR/BR Alarms and Setting Alarm Limits ... 7-3 Using the Resp Parameter Control Panel ... 7-4 Heart Rate Meter ... 7-5 Configuring Heart Rate (HR) Meter Alarms ... 7-5 Enabling/Disabling HR Alarms and Setting Alarm Limits ... 7-5 Life Threatening Rhythm Alarms ... 7-7 Using the Heart Rate Parameter Control Panel ... 7-9 RESP System Message... 7-9

Chapter 8

Monitoring Non-Invasive Blood Pressure (NIBP)

How does NIBP Work? ... 8-3 The NIBP Numeric Display ... 8-4 NIBP Setup and Use... 8-4 9650-005355-05 Rev.D

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Selecting the NIBP Cuff ... 8-5 Connecting the NIBP Cuff... 8-6 Applying the Cuff to the Patient ... 8-9 Ensuring Correct Cuff Inflation Settings... 8-10 Configuring NIBP Alarms and Settings ... 8-11 Enabling/Disabling NIBP Alarms and Setting Alarm Limits ... 8-11 Using the NIBP Parameter Control Panel ... 8-14 NIBP System Messages ... 8-17

Chapter 9

Monitoring CO2

Overview... 9-1 CO2 Monitoring Setup and Use ... 9-2 Selecting the CO2 Sampling Line ... 9-2 Connecting the CO2 Sampling Lines ... 9-3 Applying a FilterLine Set ... 9-4 Applying a Smart CapnoLine Nasal or Nasal/Oral Cannula ... 9-5 Measuring CO2... 9-6 Setting CO2 and Respiration Rate Alarms ... 9-7 Enabling/Disabling Alarms and Setting CO2 Alarm Limits ... 9-7 Using the CO2 Parameter Control Panel ... 9-9 CO2 System Messages ... 9-10

Chapter 10

Pulse CO-Oximetry (SpO2)

Warnings -- SpO2 General ... 10-3 Cautions... 10-5 SpO2 Accuracy Specifications ... 10-7 SpO2 Setup and Use ... 10-11 Selecting the SpO2 Sensor ... 10-12 Applying the SpO2 Sensor ... 10-12 Applying a Two-Piece Single-Use Sensor/Cable ... 10-13 Applying a Reusable Sensor/Cable ... 10-14 Cleaning and Reuse of Sensors ... 10-15 Connecting the SpO2 Sensor ... 10-15 Displaying Measurements ... 10-16 Enabling/Disabling SpO2 Alarms and Setting Alarm Limits ... 10-16 Setting Upper and Lower SpO2 Alarm Limits ... 10-17 Setting Upper and Lower SpCO and SpMet Alarm Limits ... 10-17 Setting Upper and Lower SpHb Alarm Limits ... 10-18 Setting Upper and Lower SpOC Alarm Limits ... 10-18 Setting Upper and Lower PVI Alarm Limits ... 10-19 Setting Upper and Lower PI Alarm Limits ... 10-19 Using the SpO2 Parameter Control Panel ... 10-20 SpCO and SpMet, and SpHb, SpOC, PVI and PI Monitoring ... 10-20 Specifying the SpO2 Averaging Time ... 10-20 Selecting the SpO2 Sensitivity ... 10-20 iv

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Selecting SpHb Venous Mode ... 10-21 Specifying the SpHb Averaging Time ... 10-21 Selecting the Heart Rate/ Pulse Rate (HR/PR) Tone ... 10-21 SpO2 System Messages ... 10-21 Functional Testers and Patient Simulators... 10-22

Chapter 11

Monitoring Invasive Pressures (IBP)

Invasive Pressure Transducers ... 11-1 IBP Setup... 11-2 Attaching the Invasive Pressure Transducer ... 11-3 Zeroing the Transducer... 11-4 Rezeroing a Transducer ... 11-5 Displaying IBP Measurements... 11-5 Conditions Affecting IBP Measurements ... 11-5 Enabling/Disabling IBP Alarms and Setting Alarm Limits... 11-6 Setting Upper and Lower Systolic (SYS) Alarm Limits ... 11-6 Setting Upper and Lower Diastolic (DIA) Alarm Limits ... 11-7 Setting Upper and Lower Mean Arterial Pressure (MEAN) Alarm Limits ... 11-7 Setting IBP Source Label ... 11-8 IBP System Messages... 11-9

Chapter 12

Monitoring Temperature

Temperature Monitoring Setup ... 12-1 Selecting and Applying Temperature Probes ... 12-2 Connecting the Temperature Probe ... 12-2 Displaying Temperature ... 12-2 Enabling/Disabling Temperature Alarms and Setting Alarm Limits ... 12-3 Setting Upper and Lower Temperature Alarm Limits ... 12-3 Setting Upper and Lower Temperature Alarm Limits ... 12-4 Selecting the Temperature Label ... 12-5 Temperature System Messages ... 12-6

Chapter 13

Automated External Defibrillator (AED) Operation

AED Operation... 13-2 Determine Patient Condition Following Medical Protocols ... 13-2 Begin CPR Following Medical Protocols ... 13-2 Prepare Patient ... 13-3 1 Turn on unit ... 13-4 2 Analyze ... 13-5 3 Press SHOCK ... 13-7 RapidShock ... 13-8 The Shock Conversion Estimator ... 13-8 Operating Messages ... 13-8 Audio and Display Messages ... 13-9 Switching to Manual Mode Operation ... 13-10 9650-005355-05 Rev.D

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Chapter 14

12-Lead ECG Interpretive Analysis

Entering Patient Information ... 14-2 Entering the Patient Name and ID ... 14-3 Entering Patient Age and Gender ... 14-3 12-Lead ECG Monitoring Setup... 14-4 Preparing the Patient for Electrode Application ... 14-5 Applying Electrodes to the Patient ... 14-5 Connecting the 12-Lead Cable ... 14-7 Observing the 12-Lead Waveform Traces ... 14-7 12-Lead Interpretive Analysis ... 14-8 Fault Conditions Affecting 12-Lead Interpretive Analysis ... 14-11 Printing 12-Lead Waveform Traces ... 14-12 12-Lead Print and Display Options ... 14-13 Selecting 12-Lead Acquire ... 14-13 Specifying the Number of 12-Lead Print Copies ... 14-13 Specifying the 12-Lead Print Format ... 14-14 Printing 10 Seconds of Waveform Traces ... 14-16 Specifying the 12-Lead Frequency Response ... 14-16 Enabling 12-Lead Analysis ... 14-16 Enabling Interpretive Text ... 14-16

Chapter 15

Manual Defibrillation

Emergency Defibrillation Procedure with Paddles ... 15-1 Determine the Patient’s Condition Following Local Medical Protocols ... 15-2 Begin CPR Following Local Medical Protocols ... 15-2 Turn On Unit ... 15-2 1 Select Energy Level ... 15-2 2 Charge Defibrillator ... 15-4 3 Deliver Shock ... 15-6 Emergency Defibrillation Procedure with Hands-Free Therapy Electrodes... 15-7 Determine the Patient’s Condition Following Local Medical Protocols ... 15-7 Begin CPR Following Medical Protocols ... 15-7 Prepare Patient ... 15-7 Turn On Unit ... 15-8 1 Select Energy Level ... 15-8 2 Charge Defibrillator ... 15-9 3 Deliver Shock ... 15-10 Internal Paddles ... 15-10 Verification Prior to Use ... 15-11 Synchronized Cardioversion ... 15-12 Synchronized Cardioversion Procedure ... 15-13 Determine the Patient’s Condition and Provide Care Following Local Medical Protocols ... 15-13 Prepare Patient ... 15-13 Turn On Unit ... 15-13

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Press the Sync Key ... 15-13 1 Select Energy Level ... 15-14 2 Charge Defibrillator ... 15-14 3 Deliver Shock ... 15-15

Chapter 16

Advisory Defibrillation

Advisory Defibrillation Procedure... 16-2 Determine the Patient’s Condition Following Local Medical Protocols ... 16-2 Begin CPR Following Local Medical Protocols ... 16-2 Prepare Patient ... 16-2 1 Turn on unit ... 16-3 2 Press ANALYZE Button ... 16-4 3 Press SHOCK button ... 16-5

Chapter 17

Analysis/CPR Protocol Defibrillation

Analysis/CPR Protocol Defibrillation Procedure ... 17-2 Determine the Patient’s Condition Following Local Medical Protocols ... 17-2 Begin CPR Following Local Medical Protocols ... 17-2 Prepare Patient ... 17-2 1 Turn on unit ... 17-3 2 Press ANALYZE Button ... 17-4 3 Press SHOCK button ... 17-5 RapidShock ... 17-6 The Shock Conversion Estimator ... 17-6

Chapter 18

External Pacing

External Pacing... 18-2 Pacer Modes ... 18-2 Pacing in Demand Mode ... 18-2 Determine Patient Condition and Provide Care Following Local Medical Protocols . 18-2 Prepare the Patient ... 18-2 1 Turn On Unit ... 18-2 2 Apply ECG Electrodes/Hands-Free Therapy Electrodes ... 18-3 3 Press PACER button ... 18-3 4 Set Mode ... 18-4 5 Set Pacer Rate ... 18-4 6 Turn On Pacer ... 18-4 7 Set Pacer Output ... 18-4 8 Determine Capture ... 18-5 9 Determine Optimum Threshold ... 18-5 Pacing in Fixed Mode ... 18-6 1 Turn On Unit ... 18-6 2 Apply ECG Electrodes/Hands-Free Therapy Electrodes ... 18-6 3 Press PACER button ... 18-7 4 Set Mode ... 18-7 5 Set Pacer Rate ... 18-7 6 Turn On Pacer ... 18-7 7 Set Pacer Output ... 18-8 9650-005355-05 Rev.D

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8 Determine Capture ... 18-8 9 Determine Optimum Threshold ... 18-8 Pediatric Pacing ... 18-9 Pace Fault ... 18-9

Chapter 19

Real CPR Help

CPR Voice Prompts (Adult Only) ... 19-3 CPR Metronome ... 19-3 Constant Metronome Enabled ... 19-3 Constant Metronome Disabled ... 19-4 FULLY RELEASE Prompt ... 19-5 CPR Dashboard... 19-5 CPR Rate and Depth Measurements ... 19-5 CPR Release Indicator (Adult Only) ... 19-6 Chest Compression Indicator (Adult Only) ... 19-6 CPR Countdown Timer ... 19-6 CPR Idle Time Display ... 19-6 CPR Compression Bar Graph (Adult Only) ... 19-7 Real CPR with AutoPulse ... 19-7 Real CPR with the ResQCPR™ System ... 19-7

Chapter 20

See -Thru CPR

Using See-Thru CPR ... 20-2 Examples ... 20-3

Chapter 21

Real BVM Help

Overview... 21-8 Ventilation Feedback ... 21-8 Volume ... 21-8 Breath Rate ... 21-9 Ventilation Quality ... 21-9 The Real BVM Help Display ... 21-9 Using Real BVM Help ... 21-11

Chapter 22

TBI Dashboard

Overview... 22-2 Parameter Trend Graphs ... 22-3 SBP Trending ... 22-4 EtCO2 Trending ... 22-4 SpO2 Trending ... 22-4 Ventilation Assistance ... 22-5 Ventilation Assistance with AccuVent Sensor ... 22-6 Using the TBI Dashboard... 22-7 References ... 22-7 viii

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Chapter 23

Patient Data

Storing Data ... 23-2 Log Capacity Indicator ... 23-2 Capturing a Data Snapshot ... 23-2 Reviewing and printing snapshots ... 23-3 Treatment Summary Report ... 23-3 Printing Treatment Summary Report ... 23-3 Transferring Data to a USB Device... 23-4 Clearing the Log ... 23-5

Chapter 24

Communications

The Wireless Icon ... 24-2 The Wireless Menu ... 24-4 Selecting a Pre-Configured Access Point Profile ... 24-5 Creating a Temporary Access Point Profile ... 24-6 Bluetooth Device Pairing ... 24-10 Sending a 12-Lead Report... 24-12 Sending Disclosure Logs ... 24-13 Automatic Case Push ... 24-14 Connecting to RescueNet Live ... 24-15 Transmitting Readiness Test Logs ... 24-16 Communications System Messages... 24-17 Transmission Status Icons... 24-18

Chapter 25

Printing

Printing Patient Data ... 25-1 Printer Setup ... 25-2 Automatic Prints ... 25-2 Printing Waveforms ... 25-2 Printing Reports ... 25-3 Printing Trends ... 25-4 Printing Readiness Test Logs ... 25-5

Chapter 26

Maintenance

Daily/Shift Check Procedure ... 26-2 Inspection ... 26-2 Defibrillator/Pacing Test with Hands-Free Therapy Electrodes... 26-3 Defibrillator Testing with External Paddles... 26-5 Recommended Minimum Preventive Maintenance Schedule ... 26-7 Annually ... 26-7 Guidelines for Maintaining Peak Battery Performance ... 26-7 Cleaning instructions ... 26-8 Cleaning the X Series Advanced unit ... 26-8 Cleaning the NIBP Blood Pressure Cuff ... 26-8 Cleaning SpO2 Sensors ... 26-8 9650-005355-05 Rev.D

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Cleaning Cables and Accessories ... 26-9 Loading Recorder Paper ... 26-9 Cleaning the Print Head ... 26-10

Appendix A

Specifications

Defibrillator...A-2 CPR Monitoring ...A-14 Compression depth ...A-14 Compression rate ...A-14 Monitor/Display ...A-14 Impedance Pneumography...A-15 Alarms...A-16 Recorder ...A-17 Battery ...A-17 General ...A-18 Pacer ...A-20 CO2 ...A-20 Pulse Oximeter ...A-21 Non-Invasive Blood Pressure ...A-25 Invasive Pressures ...A-26 AccuVent Sensor ...A-27 Temperature...A-27 Clinical Trial Results for the Biphasic Waveform ...A-28 Randomized Multicenter Clinical Trial for Defibrillation of Ventricular Fibrillation (VF) and Ventricular Tachycardia (VT) ...A-28 Randomized Multi-Center Clinical trial for Cardioversion of Atrial Fibrillation (AF) ...A-29 Pre-Clinical Study ...A-31 Published Clinical Data ...A-32 Synchronized Cardioversion of Atrial Fibrillation ...A-33 Electromagnetic Compatibility Guidance and Manufacturer’s Declaration ...A-34 Electromagnetic Immunity (IEC 60601-1-2) ...A-35 Electromagnetic Immunity ...A-36 ECG Analysis Algorithm Accuracy ...A-40 Clinical Performance Results ...A-40 Shock Conversion Estimator ...A-43 Wireless Output Guidance and Manufacturer’s Declaration ...A-45 RF Transmission Emitted (IEC 60601-1-2) ...A-45 FCC Notice ...A-45 Canada, Industry Canada (IC) Notices ...A-45

Appendix B Accessories ...B-1

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Chapter 1 General Information Product Description The ZOLL® X Series® Advanced unit is an easy-to-use portable defibrillator that combines defibrillation and external pacing with the following monitoring capabilities: • ECG

• CO-Oximeter

• Non-invasive Blood Pressure • IBP

• CO2

• Temperature • Respiration

The X Series Advanced unit is a rugged, compact and lightweight unit that is designed for all resuscitation situations and is ideal for transport. The X Series Advanced unit is powered by auxiliary power as well as an easily replaceable battery pack that quickly recharges when the X Series Advanced unit is connected to auxiliary power. In addition, you can use a ZOLL SurePower™ Battery Charger Station to recharge and test the X Series Advanced battery. Note:

The X Series Advanced unit has defibrillation and pacing functionality, but some of the monitoring functions are optional features. See the complete list of options in Fig. 1-1. All features are included in this manual, but only purchased features will be available on your unit. The product is designed for use in both the hospital and the rugged EMS environment. The device is a versatile automated external defibrillator with manual capabilities and may be configured to operate in Manual, Advisory or Semiautomatic modes. It can be configured to start up in Semiautomatic (AED) mode or manual mode.

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When operating in manual configuration, the device operates as a conventional defibrillator where the device’s charging and discharging is fully controlled by the operator. In Advisory and AED modes, some features of the device are automated and a sophisticated detection algorithm is used to identify ventricular fibrillation and determine the appropriateness of defibrillator shock delivery. Units may be configured to automatically charge, analyze, recharge, and prompt the operator to “PRESS SHOCK”, depending on local protocols. The unit is switched from AED mode to Manual mode for ACLS use by pressing the appropriate key on the front panel. The X Series Advanced unit assists caregivers during cardiopulmonary resuscitation (CPR) by evaluating the rate and depth of chest compressions and providing feedback to the rescuer. Real CPR Help® requires the use of authorized ZOLL CPR electrodes. When using these pads, the displayed ECG waveforms can be adaptively filtered, using the See-Thru CPR® feature, to reduce the artifact caused by chest compressions. The X Series Advanced unit assists caregivers during manual ventilations by providing volume and rate information of delivered breaths. The Real BVM Help feature requires use of ZOLL AccuVent sensor and cable. The unit has a large colorful LCD display of numerics and waveform data that provides easy visibility from across the room and at any angle. ECG, plethysmograph, and respiration waveform traces can be displayed simultaneously, giving easy access to all patient monitoring data at once. The display screen is configurable, so you can choose the best visual layout to fit your monitoring needs. The X Series Advanced unit includes a transcutaneous pacemaker consisting of a pulse generator and ECG sensing circuitry. Pacing supports both demand and fixed noninvasive pacing for adult patients and adolescent, child, and infant pediatric patients. The X Series Advanced unit has a patient data review and collection system that allows you to view, store, and transfer patient data. The X Series Advanced unit contains a printer and USB port, which you can use to print the data and transfer it to a PC. The X Series Advanced unit can send data through a wireless connection to remote locations. The X Series Advanced unit can send 12-lead report snapshots (including trend data) or Disclosure Logs to a recipient via a ZOLL server. In addition full disclosure cases, which also contain trend data, can be automatically retrieved from the X Series Advanced unit using ZOLL RescueNet or ePCR software.

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How to Use This Manual

X Series Advanced Optional Features The following features are optional in the X Series Advanced unit. Note:

All features are included in this manual, but only purchased features will be available on your unit.

Figure 1-1 X Series Advanced Optional Features Optional Feature 12-Lead ECG with Interpretation SpCO® and SpMet® SpHb® (Masimo®) with SpOCTM, PVI® and PI NIBP (with Smartcuf® and SureBPTM) EtCO2 (Oridion® Microstream®) Temperature (2 Channels) Invasive Pressures (3 Channels) Pacing Microphone

How to Use This Manual The X Series Advanced Operator's Guide provides information operators need for the safe and effective use and care of the X Series Advanced product. It is important that all persons using this device read and understand all the information contained within. Please thoroughly read the safety considerations and warnings section. Procedures for daily checkout and unit care are located in the Chapter 26, "Maintenance". This manual is supplemented by manual insert(s) for option(s) available on the X Series Advanced unit. These insert(s) contain additional warnings, precautions, and safety-related information.

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Operator’s Guide Updates An issue or revision date for this manual is shown on the front cover. If more than three years have elapsed since this date, contact ZOLL Medical Corporation to determine if additional product information updates are available. All users should carefully review each manual update to understand its significance and then file it in its appropriate section within this manual for subsequent reference. Product documentation is available through the ZOLL website at www.zoll.com. From the Products menu, choose Product Manuals.

Unpacking Carefully inspect each container for damage. If the shipping container or cushion material is damaged, keep it until the contents have been checked for completeness and the instrument has been checked for mechanical and electrical integrity. If the contents are incomplete, if there is mechanical damage, or if the defibrillator does not pass its electrical self-test, U.S.A. customers should call ZOLL Medical Corporation (1-800-348-9011). Customers outside of the U.S.A. should contact the nearest ZOLL authorized representative. If the shipping container is damaged, also notify the carrier.

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Symbols Used on the Equipment

Symbols Used on the Equipment Any or all of the following symbols may be used in this manual or on this equipment: Symbol

Description Class II equipment.

Dangerous voltage.

General warning: Observe and follow all safety signs.

Hot surface.

Fragile, handle with care.

Keep dry.

This end up.

Temperature limitation.

Conformité Européenne Complies with medical device directive 93/42/EEC.

Type B patient connection.

Type BF patient connection.

Type CF patient connection.

Defibrillator-proof type BF patient connection.

Defibrillator-proof type CF patient connection.

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