X Series Operators Guide Rev H May 2014.pdf
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X Series Operator’s Guide
®
9650-001355-01 Rev. H
Page 2
The issue date for the X Series Operator's Guide (REF 9650-001355-01 Rev. H) is May, 2014.
If more than 3 years have elapsed since the issue date, contact ZOLL Medical Corporation to determine if
additional product information updates are available.
Copyright © 2014 ZOLL Medical Corporation. All rights reserved. CPR-D-padz, Pedi-padz, OneStep, Real
CPR Help, Rectilinear Biphasic, RescueNet, See-Thru CPR, Stat-padz, SurePower, X Series, 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, and SpMet are trademarks or registered trademarks of Masimo Corporation in
the United States and/or other countries.
IC Model: XSCP-1
ZOLL Medical Corporation
269 Mill Road
Chelmsford, MA USA
01824-4105
ZOLL International Holding B.V.
Newtonweg 18
6662 PV ELST
The Netherlands
0123
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Table of Contents
Chapter 1
General Information
Product Description ............................................................................................................ 1-1
X Series Optional Features ......................................................................................... 1-2
How to Use This Manual..................................................................................................... 1-3
Operator’s Guide Updates .................................................................................................. 1-3
Unpacking ........................................................................................................................... 1-3
Symbols Used on the Equipment ....................................................................................... 1-4
Conventions ........................................................................................................................ 1-7
X Series Indications for Use ............................................................................................... 1-7
Manual Defibrillation ................................................................................................... 1-8
Semiautomatic Operation (AED) ................................................................................ 1-8
ECG Monitoring .......................................................................................................... 1-9
CPR Monitoring .......................................................................................................... 1-9
External Transcutaneous Pacing ................................................................................ 1-9
Non-Invasive Blood Pressure Monitoring ................................................................... 1-9
Temperature Monitoring ............................................................................................. 1-9
SpO2 Monitoring ....................................................................................................... 1-10
Respiration Monitoring .............................................................................................. 1-10
CO2 Monitoring ......................................................................................................... 1-10
Invasive Pressure Monitoring ................................................................................... 1-10
12-Lead Analysis ...................................................................................................... 1-10
X Series Product Functions .............................................................................................. 1-11
Defibrillator Function ................................................................................................. 1-11
Defibrillator Output Energy ....................................................................................... 1-11
External Pacemaker ................................................................................................. 1-11
ECG Monitoring ........................................................................................................ 1-11
Electrodes ................................................................................................................. 1-12
Batteries .................................................................................................................... 1-12
Ready For Use (RFU) Indicator ................................................................................ 1-13
Safety Considerations....................................................................................................... 1-15
Warnings........................................................................................................................... 1-15
General ..................................................................................................................... 1-15
ECG Monitoring ........................................................................................................ 1-16
Defibrillation .............................................................................................................. 1-17
Pacing ....................................................................................................................... 1-18
CPR .......................................................................................................................... 1-19
Pulse Oximeter ......................................................................................................... 1-19
Noninvasive Blood Pressure ..................................................................................... 1-20
IBP ............................................................................................................................ 1-20
CO2 ........................................................................................................................... 1-21
Respiration ................................................................................................................ 1-21
Ferromagnetic Equipment ........................................................................................ 1-21
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Battery ...................................................................................................................... 1-21
Operator Safety ........................................................................................................ 1-22
Patient Safety ........................................................................................................... 1-23
Cautions............................................................................................................................ 1-24
Restarting the Defibrillator ................................................................................................ 1-25
FDA Tracking Requirements............................................................................................. 1-25
Notification of Adverse Events .................................................................................. 1-26
Software License .............................................................................................................. 1-26
Service.............................................................................................................................. 1-27
The ZOLL Serial Number.................................................................................................. 1-28
Chapter 2
Product Overview
Defibrillator Controls and Indicators.................................................................................... 2-1
The Front Panel .......................................................................................................... 2-2
Display Screen ............................................................................................................ 2-4
Battery Status and Auxiliary Power Indicators ............................................................ 2-6
Patient Cables and Connectors .................................................................................. 2-7
External Paddles ....................................................................................................... 2-10
AC Auxiliary Power Adapter ..................................................................................... 2-13
DC Auxiliary Power Supply (optional) ....................................................................... 2-14
Connecting the DC Auxiliary Power Supply to a Suitable Vehicle Power Source .... 2-14
Connecting AC Auxiliary Power Adapter or DC Auxiliary Power Supply to X Series
Unit ......................................................................................................................... 2-15
Navigating the Display Screen.......................................................................................... 2-15
Quick Access Keys ................................................................................................... 2-16
Navigation Keys ....................................................................................................... 2-19
Display Brightness .................................................................................................... 2-19
Common Tasks ................................................................................................................. 2-19
Changing the Display Brightness .............................................................................. 2-19
Replacing a Battery Pack on the X Series ................................................................ 2-20
Using Treatment Buttons .......................................................................................... 2-21
Chapter 3
Monitoring Overview
X Series Monitoring Functions ............................................................................................ 3-1
ECG ............................................................................................................................ 3-2
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 ................................................................................................. 3-3
Configuring the Waveform Display ..................................................................................... 3-7
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Chapter 4
Trends
Displaying the Trends Status Window ................................................................................ 4-1
Displaying and Printing Trend Information.......................................................................... 4-2
Changing the Trends Status Window Display..................................................................... 4-3
Continuous Waveform Recording ............................................................................... 4-3
Chapter 5
Alarms
Visual Alarm Indicators ....................................................................................................... 5-1
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 -- Silencing the Alarm .......................................................... 5-5
Re-enabling an Alarm ................................................................................................. 5-5
Suspending Alarms............................................................................................................. 5-5
The Alarm Suspension Timer ..................................................................................... 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........................................................................................................ 6-2
Preparing the Patient for Electrode Application .......................................................... 6-2
Applying Electrodes to the Patient .............................................................................. 6-3
Connecting the ECG Cable To the X Series Unit ....................................................... 6-5
Selecting ECG Waveforms for Display ....................................................................... 6-6
Selecting the Waveform Trace Size ........................................................................... 6-8
ECG Monitoring and Pacemakers ...................................................................................... 6-9
ECG System Messages...................................................................................................... 6-9
Chapter 7
Monitoring Respiration (Resp) and Heart Rate (HR)
Respiration/Breath Rate Meter ........................................................................................... 7-2
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 ............................................ 7-6
Life Threatening Rhythm Alarms ................................................................................ 7-7
Using the Heart Rate Parameter Control Panel .......................................................... 7-9
RESP System Message ................................................................................................... 7-10
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Chapter 8
Monitoring Non-Invasive Blood Pressure (NIBP)
How does NIBP Work? ....................................................................................................... 8-2
The NIBP Numeric Display ................................................................................................. 8-3
NIBP Setup and Use........................................................................................................... 8-3
Selecting the NIBP Cuff ...................................................................................................... 8-4
Connecting the NIBP Cuff................................................................................................... 8-5
Applying the Cuff to the Patient .......................................................................................... 8-7
Ensuring Correct Cuff Inflation Settings.............................................................................. 8-8
Configuring NIBP Alarms and Settings ............................................................................... 8-9
Enabling/Disabling NIBP Alarms and Setting Alarm Limits ........................................ 8-9
Using the NIBP Parameter Control Panel ................................................................. 8-11
NIBP System Messages ................................................................................................... 8-14
Chapter 9
Monitoring CO2
Overview............................................................................................................................. 9-1
CO2 Monitoring Setup and Use .......................................................................................... 9-2
Selecting the CO2 Sampling Line ............................................................................... 9-3
Connecting the CO2 Sampling Lines .......................................................................... 9-4
Applying a FilterLine Set ............................................................................................. 9-5
Applying a Smart CapnoLine Nasal or Nasal/Oral Cannula ....................................... 9-6
Measuring CO2 ................................................................................................................... 9-7
Setting CO2 and Respiration Rate Alarms.......................................................................... 9-8
Enabling/Disabling Alarms and Setting CO2 Alarm Limits .......................................... 9-8
Using the CO2 Parameter Control Panel .................................................................. 9-10
CO2 System Messages .................................................................................................... 9-11
Patents.............................................................................................................................. 9-12
Chapter 10
Pulse CO-Oximetry (SpO2, SPCO, and SpMet)
Warnings -- SpO2, General ............................................................................................... 10-2
Warnings -- SpO2, Oximeter Sensor................................................................................. 10-3
SpO2 Setup and Use ........................................................................................................ 10-4
Selecting the SpO2 Sensor ............................................................................................... 10-4
Applying the SpO2 Sensor ................................................................................................ 10-4
Applying a Two-Piece Single-Use Sensor/Cable ...................................................... 10-5
Applying a Reusable SpO2 Sensor/Cable ................................................................ 10-7
Cleaning and Reuse of Sensors ............................................................................... 10-8
Connecting the SpO2 Sensor............................................................................................ 10-8
Displaying SpO2, SpCO, and SpMet Measurements ........................................................ 10-8
Enabling/Disabling SpO2 Alarms and Setting Alarm Limits .............................................. 10-9
Setting Upper and Lower SpO2 Alarm Limits ........................................................... 10-9
Setting Upper and Lower SpCO and SpMet Alarm Limits ...................................... 10-10
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Using the SpO2 Parameter Control Panel ...................................................................... 10-10
Selecting the SpCO and SpMet Monitoring ............................................................ 10-10
Specifying the SpO2 Averaging Time ..................................................................... 10-11
Selecting the SpO2 Sensitivity ................................................................................ 10-11
Selecting the Heart Rate/ Pulse Rate (HR/PR) Tone ............................................. 10-11
SpO2 System Messages................................................................................................. 10-11
Functional Testers and Patient Simulators ..................................................................... 10-13
Chapter 11
Monitoring Invasive Pressures (IBP)
Invasive Pressure Transducers ........................................................................................ 11-1
IBP Setup.......................................................................................................................... 11-2
Attaching the Invasive Pressure Transducer .................................................................... 11-2
Zeroing the Transducer..................................................................................................... 11-3
Rezeroing a Transducer ................................................................................................... 11-4
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.................................................................... 12-1
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 ...................................................................................... 12-4
Temperature System Messages ....................................................................................... 12-5
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 ............................................................................................................ 13-3
2 Analyze .................................................................................................................. 13-5
3 Press SHOCK ........................................................................................................ 13-7
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Operating Messages ................................................................................................. 13-8
Audio and Display Messages ................................................................................... 13-8
Switching to Manual Mode Operation ............................................................................. 13-10
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 ............................................................................. 14-4
12-Lead ECG Monitoring Setup........................................................................................ 14-4
Preparing the Patient for Electrode Application ........................................................ 14-4
Applying Electrodes to the Patient ............................................................................ 14-5
Connecting the 12-Lead Cable ................................................................................. 14-7
Observing the 12-Lead Waveform Traces ................................................................ 14-8
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 ...................................................................................... 14-14
Specifying the Number of 12-Lead Print Copies ..................................................... 14-14
Specifying the 12-Lead Print Format ...................................................................... 14-14
Printing 10 Seconds of the Lead ll Waveform Trace .............................................. 14-14
Specifying the 12-Lead Frequency Response ........................................................ 14-14
Enabling 12-Lead Analysis ..................................................................................... 14-15
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 ................................................................................................ 15-3
3 Deliver Shock ......................................................................................................... 15-5
Emergency Defibrillation Procedure with Hands-Free Therapy Electrodes...................... 15-6
Determine the Patient’s Condition Following Local Medical Protocols ..................... 15-6
Begin CPR Following Medical Protocols .................................................................. 15-6
Prepare Patient ......................................................................................................... 15-6
Turn On Unit ............................................................................................................. 15-7
1 Select Energy Level ............................................................................................... 15-7
2 Charge Defibrillator ................................................................................................ 15-8
3 Deliver Shock ......................................................................................................... 15-9
Internal Paddles ................................................................................................................ 15-9
Verification Prior to Use .......................................................................................... 15-10
Synchronized Cardioversion ........................................................................................... 15-11
Synchronized Cardioversion Procedure ......................................................................... 15-12
Determine the Patient’s Condition and Provide Care Following Local Medical
Protocols .............................................................................................................. 15-12
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Prepare Patient ....................................................................................................... 15-12
Turn On Unit ........................................................................................................... 15-12
Press the Sync Key ................................................................................................ 15-12
1 Select Energy Level ............................................................................................. 15-13
2 Charge Defibrillator .............................................................................................. 15-13
3 Deliver Shock ....................................................................................................... 15-14
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
Advisory/CPR Protocol Defibrillation
Advisory/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
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 ................................................................................................ 18-4
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
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5 Set Pacer Rate ...................................................................................................... 18-7
6 Turn On Pacer ....................................................................................................... 18-7
7 Set Pacer Output ................................................................................................... 18-7
8 Determine Capture ................................................................................................ 18-8
9 Determine Optimum Threshold .............................................................................. 18-8
Pediatric Pacing ........................................................................................................ 18-9
Chapter 19
Real CPR Help
CPR Voice Prompts .......................................................................................................... 19-2
CPR Metronome ............................................................................................................... 19-2
CPR Dashboard................................................................................................................ 19-3
Rate and Depth Measurements ................................................................................ 19-3
CPR Release Indicator ............................................................................................. 19-3
Chest Compression Indicator ................................................................................... 19-4
CPR Countdown Timer ............................................................................................. 19-4
CPR Idle Time Display .............................................................................................. 19-4
FULLY RELEASE Prompt ........................................................................................ 19-5
CPR Compression Bar Graph .......................................................................................... 19-5
Chapter 20
See-Thru CPR
Using See-Thru CPR ........................................................................................................ 20-2
Examples .................................................................................................................. 20-2
Chapter 21
Patient Data
Storing Data ...................................................................................................................... 21-1
Log Capacity Indicator .............................................................................................. 21-2
Capturing a Data Snapshot............................................................................................... 21-2
Reviewing and printing snapshots ............................................................................ 21-2
Treatment Summary Report ............................................................................................. 21-3
Printing Treatment Summary Report ........................................................................ 21-3
Transferring Data to a USB Device................................................................................... 21-4
Clearing the Log ....................................................................................................... 21-4
Chapter 22
Wireless Communications
The Wireless Icon ............................................................................................................. 22-2
The Wireless Menu ........................................................................................................... 22-3
Creating a Temporary Access Point Profile .............................................................. 22-3
Bluetooth Device Pairing .......................................................................................... 22-8
Setting up Communications in the Supervisor Menu ...................................................... 22-10
Setting up Wireless Profiles .................................................................................... 22-10
WiFi Access Point Profiles ...................................................................................... 22-12
Setting up Cellular Communications ....................................................................... 22-18
Setting up an Ethernet Connection ......................................................................... 22-22
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Configuring Report Transmissions ......................................................................... 22-23
Sending a 12-lead report ................................................................................................ 22-23
Communications System Messages............................................................................... 22-25
Transmission Status of 12 Lead Snapshots.................................................................... 22-26
Chapter 23
Printing
Printing Patient Data ......................................................................................................... 23-1
Printer Setup ............................................................................................................. 23-2
Automatic Prints ........................................................................................................ 23-2
Printing Waveforms .................................................................................................. 23-2
Printing Reports ........................................................................................................ 23-3
Printing Trends ......................................................................................................... 23-4
Chapter 24
Maintenance
Daily/Shift Check Procedure ............................................................................................. 24-2
Inspection ................................................................................................................. 24-2
Defibrillator/Pacing Test with Hands-Free Therapy Electrodes......................................... 24-3
Defibrillator Testing with External Paddles........................................................................ 24-5
Recommended Minimum Preventive Maintenance Schedule .......................................... 24-7
Annually .................................................................................................................... 24-7
Guidelines for Maintaining Peak Battery Performance ..................................................... 24-7
Cleaning instructions ........................................................................................................ 24-8
Cleaning the X Series unit ........................................................................................ 24-8
Cleaning the NIBP Blood Pressure Cuff ................................................................... 24-8
Cleaning SpO2 Sensors ............................................................................................ 24-9
Cleaning Cables and Accessories ............................................................................ 24-9
Loading Recorder Paper ........................................................................................... 24-9
Cleaning the Print Head .......................................................................................... 24-10
Appendix A Specifications
Defibrillator..........................................................................................................................A-2
Monitor/Display .................................................................................................................A-14
Impedance Pneumography...............................................................................................A-15
Alarms...............................................................................................................................A-16
Recorder ...........................................................................................................................A-17
Battery ..............................................................................................................................A-17
General .............................................................................................................................A-18
Pacer ................................................................................................................................A-19
CO2 ...................................................................................................................................A-19
Pulse Oximeter .................................................................................................................A-20
Non-Invasive Blood Pressure ...........................................................................................A-22
Invasive Pressures ...........................................................................................................A-23
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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
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Chapter 1
General Information
Product Description
The ZOLL® X Series® unit is an easy-to-use portable defibrillator that combines defibrillation
and external pacing with the following monitoring capabilities: ECG, CO-Oximeter, Noninvasive Blood Pressure, IBP, CO2, Temperature, and Respiration. It has been designed for all
resuscitation situations and its rugged, compact, lightweight design makes it ideal for transport
situations. It is powered by auxiliary power and an easily replaced battery pack that is quickly
recharged in the device when it is connected to auxiliary power. In addition, the unit’s battery
may be recharged and tested using a ZOLL SurePower™ Battery Charger Station.
Note:
The X Series 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.
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.
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CHAPTER 1 GENERAL INFORMATION
The X Series 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 ZOLL OneStep™ CPR electrodes, OneStep™ Complete
electrodes, or CPR-D-padz®. 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 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 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 has a patient data review and collection system that allows you to view, store, and
transfer patient data. The X Series unit contains a printer and USB port, which you can use to
print the data and transfer it to a PC.
The X Series unit can send data through a wireless connection to remote locations. The
X Series unit can send 12-lead report snapshots (including trend data) to a recipient via a ZOLL
server. Full disclosure cases, which also contain trend data, can be automatically retrieved from
the X Series unit using ZOLL RescueNet or ePCR software.
X Series Optional Features
The following features are optional in the X Series unit.
Note:
All features are included in this manual, but only purchased features will be available
on your unit.
Figure 1-1 X Series Optional Features
Optional Feature
12-Lead ECG with Interpretation
SpO2 (Masimo®) with SpCO® and SpMet®
NIBP (with Smartcuf® and SureBPTM)
EtCO2 (Oridion® Microstream®)
Temperature (2 Channels)
Invasive Pressures (3 Channels)
Advanced CPR Help
Pacing
Microphone
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How to Use This Manual
How to Use This Manual
The X Series Operator's Guide provides information operators need for the safe and effective
use and care of the X Series 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 24, "Maintenance".
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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CHAPTER 1 GENERAL INFORMATION
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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Symbols Used on the Equipment
Symbol
Description
Fusible link.
Equipotentiality.
Alternating current (ac).
Direct current (dc).
Auxiliary power adapter operation.
Caution, high voltage.
Earth (ground).
Negative input terminal.
Positive input terminal.
Power On/Off
,I
2.
45
2%
)/.
Protective earth (ground).
Contains lithium. Recycle or dispose of properly.
R EC Y C LE
,I )/.
Keep away from open flame and high heat.
Do not open, disassemble, or intentionally damage.
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CHAPTER 1 GENERAL INFORMATION
Symbol
Description
Do not crush.
Do not discard in trash. Recycle or dispose of properly.
Return to a collection site intended for waste electrical and electronic
equipment (WEEE). Do not dispose of in unsorted trash.
Date of manufacture.
Use by.
Latex-free.
Do not reuse.
Do not fold.
Not sterile.
Manufacturer.
Authorized representative in the European Community.
Serial Number.
Catalogue number.
Consult instructions for use.
Refer to instruction manual/booklet.
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Conventions
Symbol
Description
Prescription only.
Battery charging status.
MR
Do not use device, cables, or probes in an MRI environment.
Conventions
This guide uses the following conventions:
Within text, the names and labels for physical buttons and softkeys appear in boldface type (for
example, “Press the Charge button or press the Pacer button”).
This guide uses uppercase italics for audible prompts and for text messages displayed on the
screen (for example, LEAD FAULT).
Warning!
Warning statements alert you to conditions or actions that can result in personal injury
or death.
Caution
Caution statements alert you to conditions or actions that can result in damage to the unit.
X Series Indications for Use
The X Series is intended for use by trained medical personnel who are familiar with basic
monitoring, vital sign assessment, emergency cardiac care, and the use of the X Series.
The X Series is also intended for use by (or on the order of) physicians at the scene of an
emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other
similar areas of a hospital. The usage may be in an ambulance or at the scene of an emergency.
It is also intended to be used during the transport of patients. The X Series will be used
primarily on patients experiencing symptoms of cardiac arrest or in post trauma situation. It
may also be used whenever it is required to monitor any of those functions that are included (as
options) in the device. The X Series unit can be used on pediatric patients (as described in the
following table) and on adult patients (21 years of age or older) with and without heart
dysfunction.
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CHAPTER 1 GENERAL INFORMATION
Pediatric Patient Subpopulation
Approximate Age Range
Newborn (neonate)
Birth to 1 month of age.
Infant
1 month to 2 years of age.
Child
2 to 12 years of age.
Adolescent
12 to 21 years of age.
When the pediatric patient is less than 8 years of age or weighs less than 55 lbs. (25 kg.), use
ZOLL Pedi-padz® pediatric defibrillation electrodes. Do not delay therapy to determine the
patient’s exact age or weight. AED mode and ALS rescue protocol are not intended for use on
neonatal patients.
Manual Defibrillation
Use of the X Series in the manual mode for external and internal defibrillation is indicated on
victims of cardiac arrest where there is apparent lack of circulation as indicated by:
• Unconsciousness.
• Absence of breathing.
• Absence of pulse.
This product should be used only by qualified medical personnel for converting ventricular
fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable
of producing hemodynamically significant heart beats.
The unit can also be used for synchronized cardioversion of certain atrial or ventricular
arrhythmias. Qualified medical personnel must decide when synchronized cardioversion is
appropriate.
The patient population will range from newborn (neonate) to adult.
Semiautomatic Operation (AED)
X Series products are designed for use by emergency care personnel who have completed
training and certification requirements applicable to the use of a defibrillator where the device
operator controls delivery of shocks to the patient.
They are specifically designed 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.
Use of the X Series in the Semiautomatic mode for defibrillation is indicated on victims of
cardiac arrest where there is apparent lack of circulation as indicated by:
• Unconsciousness.
• Absence of breathing.
• Absence of pulse.
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X Series Indications for Use
Specifications for the ECG rhythm analysis function are provided in the section “ECG Analysis
Algorithm Accuracy” on page A-35.
When the patient is less than 8 years of age or weighs less that 55 lbs. (25 Kg), you must use
ZOLL pediatric defibrillation electrodes. Do not delay therapy to determine patient’s exact age
or weight.
ECG Monitoring
The X Series is intended for use to monitor and/or record 3-, 5-, or 12-lead ECG waveform and
heart rate, and to alarm when heart rate is above or below limits set by the operator. The patient
population will range from newborn (neonate) to adult, with and without heart dysfunction.
CPR Monitoring
The CPR monitoring function provides visual and audio feedback designed to encourage
rescuers to perform chest compressions at the AHA/ERC recommended rate of 100
compressions per minute. Voice and visual prompts encourage a minimum compression depth
of at least 1.5 (3.8 cm) or 2.0 inches (5.0 cm), depending on the configuration, for adult
patients. The CPR monitoring function is not intended for use on patients under 8 years of age.
External Transcutaneous Pacing
This product can be used for temporary external cardiac pacing in conscious or unconscious
patients as an alternative to endocardial stimulation.
The purposes of pacing include:
• Resuscitation from standstill or bradycardia of any etiology:
• As a standby when standstill or bradycardia might be expected:
• Suppression of tachycardia.
• Pediatric pacing.
Non-Invasive Blood Pressure Monitoring
The X Series is intended 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. Measurements
are made using an inflatable cuff on the patient's arm or leg. The patient population will range
from newborn (neonate) to adult.
Temperature Monitoring
The X Series is intended 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 patient population will range from newborn (neonate) to adult.
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CHAPTER 1 GENERAL INFORMATION
SpO2 Monitoring
The X Series pulse CO-oximeter, with Masimo Rainbow® SET technology and the Rainbow
series of sensors, is intended for use for continuous noninvasive monitoring of functional
oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation
(SpCO), and/or methemoglobin saturation (SpMet). 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 is intended 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
patient population will range from newborn (neonate) to adult.
CO2 Monitoring
The X Series is intended for use to make continuous noninvasive measurement and monitoring
of carbon dioxide concentration of the expired and inspired breath and breath rate. The patient
population will range from newborn (neonate) to adult.
Invasive Pressure Monitoring
The X Series is intended for use to display and make continuous invasive pressure
measurements from any compatible pressure transducer. The primary intended uses are arterial
blood pressure, central venous pressure and intracranial pressure monitoring. Any contraindications of the particular transducer selected by the user shall apply. The patient population
will range from newborn (neonate) to adult.
12-Lead Analysis
The 12-lead ECG Analysis is intended for use in acquiring, analyzing and reporting ECG data,
and to provide interpretation of the data for consideration by caregivers. The interpretations of
ECG data offered by the device are only significant when used in conjunction with caregiver
overread as well as consideration of all other relevant patient data. The 12-lead ECG Analysis
is intended for use on adults (> 18 years of age).
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X Series Product Functions
X Series Product Functions
Defibrillator Function
The X Series contains a direct current (dc) defibrillator capable of delivering up to 200 joules. It
may be used in synchronized mode to perform synchronized cardioversion using the patient’s
R-wave as a timing reference. The unit uses paddles or disposable, pregelled electrodes for
defibrillation.
Defibrillator Output Energy
X Series defibrillators can deliver biphasic energy from 1 joule to 200 joules. The energy
delivered through the chest wall, however, is determined by the patient’s transthoracic
impedance. An adequate amount of electrolyte gel must be applied to the paddles and a force of
10 to 12 kilograms (22 to 26.4 pounds) must be applied to each paddle in order to minimize this
impedance. If hands-free therapy electrodes are used, make sure that they are properly applied.
(Refer to the instructions on the electrode package).
External Pacemaker
X Series defibrillators include a transcutaneous pacemaker consisting of a pulse generator and
ECG-sensing circuitry. Noninvasive transcutaneous pacing (NTP) is an established and proven
technique. This therapy is easily and rapidly applied in both emergency and nonemergency
situations when temporary cardiac stimulation is indicated.
The output current of the pacemaker is continuously variable from 10 to 140 mA (the output
current is 0 mA when paused). The rate is continuously variable from 30 to 180 pulses per
minute (ppm), by increments of 5 ppm (10 bpm when greater than 100 ppm).
The pacing output pulse is delivered to the heart via ZOLL hands-free defibrillation/pacing
electrodes placed on the patient’s back and the precordium.
Proper operation of the device, together with correct electrode placement, is critical to
obtaining optimal results. Every operator must be thoroughly familiar with these operating
instructions.
ECG Monitoring
The patient’s ECG is monitored by connecting the patient to the unit via a 3-, 5-, or 12-lead
patient cable or hands-free therapy electrodes. The ECG waveform is presented on the display
along with the following information:
• averaged heart rate, derived by measuring R to R intervals
• lead selection - I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 (with ECG cable),
PADDLES, or PADS.
• ECG size - 0.125, 0.25, 0.50, 1.0, 2.0, 4.0 cm/mV, AUTO
• status messages
The ECG bandwidth is user selectable.
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CHAPTER 1 GENERAL INFORMATION
Electrodes
The X Series units will defibrillate, cardiovert, and monitor ECG using hands-free therapy
electrodes. The X Series unit will pace using ZOLL hands-free therapy electrodes.
Energy Select, Charge and Shock controls are located on the paddles and front panel. When
using hands-free therapy electrodes, you must use the controls on the front panel of the unit. To
switch between paddles and hands-free therapy electrodes, remove the multifunction cable
(MFC or OneStep) from the apex paddle and connect the hands-free therapy electrodes to the
cable.
You should always check the expiration date on the electrode packaging. Do not use expired
electrodes, which might result in false patient impedance readings and affect the level of
delivered energy, or cause burns.
This symbol on the electrode package is accompanied by the expiration date.
For Stat-padz® II, this symbol does not appear; the expiration date appears on the
lower right corner of the label, below the lot number.
Note:
ZOLL electrodes contain no hazardous materials and may be disposed of in general
trash unless contaminated with pathogens. Use appropriate precautions when
disposing of contaminated electrodes.
When the patient is less than 8 years old or weighs less than 55 lb. (25 kg), use ZOLL OneStep
Pediatric defibrillation electrodes. Do not delay therapy to determine the patient’s exact age or
weight.
Batteries
X Series models use an easily replaced rechargeable lithium-ion battery pack (the SurePower II
Battery Pack). A new, fully charged battery pack typically delivers more than 6 hours of ECG
monitoring. Use of other functions (such as the defibrillator, printer, or pacemaker) reduces this
time.
When a LOW BATTERY icon appears on the display and the unit emits three beeps in
conjunction with the displayed battery icon, the battery must be replaced and recharged.
You can charge the battery by either of the following methods:
• Internal charging — plug the X Series into an auxiliary power adapter to automatically
begin charging the installed battery pack. The front panel battery indicator operates as
follows:
Note:
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When the indicator is:
It means:
Steady yellow
Battery is charging.
Steady green
Battery is charged.
Alternating yellow and
green
The charge state cannot be
determined or a battery charging
fault has been detected.
Not lit
No battery in device.
Upon power up, it takes approximately 45 seconds for the LEDs on the battery to
accurately display run time.
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X Series Product Functions
• External charging — use the ZOLL SurePower Battery Charger with the X Series battery
adapter to charge the battery pack and test the battery’s capacity. For details, refer to the
SurePower II Battery Pack Guide.
The Recalibration LED icon ( ) lights for approximately 10 seconds (after you press and
release the Display button) if the battery needs to be calibrated. If the Recalibration LED lights,
the runtime indicator will not display run time for that battery. For best performance of the
battery, you should recalibrate the battery as soon as possible.
To manually recalibrate the SurePower II Battery Pack, you can insert the battery into the
SurePower Charger Station and perform a Manual Test (for more information, see the ZOLL
SurePower Charger Station Operator’s Guide).
After you recalibrate the battery, the Recalibration LED will only flash when you press the
Display button.
Ready For Use (RFU) Indicator
The X Series has an RFU indicator on the front panel that indicates if the device is ready for
use. The RFU indicator has three states which are described in the following table.
State
Description
Action
Ready for Use
The device is ready for use. Patient None required.
monitoring, defibrillation, and
pacing parameters are functional
and the battery is above the low
battery capacity.
Note: If the device is plugged into
the auxiliary power adapter, the
Ready for Use indicator may display
even if the battery is depleted.
Check the status of the battery
before removing the device from the
auxiliary power adapter.
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