X Series Operators Guide Rev H May 2014

Page 1

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

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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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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State

Description

Action

Flashing

One or more of the following has

occurred:

Install a fully charged battery in the

unit and check the RFU indicator

again. If the RFU indicator

continues to flash, remove the unit

from service and contact the

appropriate technical personnel or

the ZOLL Technical Service

Department.

• The battery is not properly

installed.

• A low battery is installed.

• A battery fault has occurred.

• There is no battery installed

while connected to auxiliary

power.

• One or more patient monitoring

parameters have failed self-test

(NIBP, SpO2, CO2, IBP, or

Temp).

• The front panel button self-test

failed.

• The speech database self-test

failed.

Do Not Use

One or more of the following has

occurred:

• The battery is not properly

installed.

• No battery is installed and

auxiliary power is not present.

• A very low battery (below

software shutdown limit) was

installed.

• ECG, defibrillator, or pacer selftests have failed, or other critical

self-tests have failed.

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Install a fully charged battery in the

unit and check the RFU indicator

again. If the RFU indicator

continues to display the Do Not

Use symbol, remove the unit from

service and contact the appropriate

technical personnel or the ZOLL

Technical Service Department.

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Safety Considerations

Safety Considerations

All operators should review these safety considerations before using the X Series unit.

X Series units are high-energy defibrillators capable of delivering 200 joules. To completely

deactivate the unit, press the power switch to turn the unit off.

To manually disarm a charged (or charging) defibrillator, do one of the following:

• Press the Disarm quick access key.

• Change the selected energy.

• Press the power switch to turn the unit off.

For safety, the X Series automatically disarms if left charged for more than 60 seconds if the

shock button ( ) is not pressed.

Warnings

General

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

Only appropriately trained, skilled personnel who are familiar with equipment operation should

perform emergency defibrillation. The prescribing physician should determine what training,

such as Advanced Cardiac Life Support (ACLS) or Basic Life Support (BLS) certification, is

appropriate.

Only skilled personnel trained in Advanced Cardiac Life Support (ACLS) and who are familiar

with equipment operation should perform synchronized cardioversion. The precise cardiac

arrhythmia must be determined before attempting defibrillation.

These operating instructions describe the functions and proper operation of the X Series

products. They are not a substitute for a formal patient care training course. Operators should

obtain formal training from an appropriate authority before using this defibrillator for patient

care.

Proper operation of the unit and correct electrode placement is critical to obtaining optimal

results. Operators must be thoroughly familiar with proper device operation.

The use of external pacing/defibrillation electrodes, accessories, or adapter devices from

sources other than ZOLL is not recommended. ZOLL makes no representations or warranties

regarding the performance or effectiveness of its products when used with pacing/defibrillation

electrodes or adapter devices from other sources. Defibrillator failures attributable to the use of

pacing/defibrillation electrodes or adapters not manufactured by ZOLL might void ZOLL’s

warranty.

At receipt of shipment, check pacing/defibrillation electrodes to ensure compatibility.

Allow ample slack in cables to make sure that cables do not tug at electrodes.

Do not disassemble the unit. A shock hazard exists. Refer all problems to authorized service

personnel.

Follow all recommended maintenance instructions. If a problem occurs, obtain service

immediately. Do not use the defibrillator until it has been inspected by appropriate personnel.

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The X Series unit might not perform to specifications when stored at the upper or lower

extreme limits of storage temperature and then immediately put into use. The X Series unit

should not be stored or used outside of the environmental limits provided in Appendix A of this

manual.

Avoid using the X Series adjacent to, or stacked on, other equipment. If unavoidable, verify that

the unit operates normally in this configuration before clinical use.

The X Series unit should be installed and put into service according to the EMC information in

Appendix A of this manual.

Do not use internal paddles while the X Series unit’s auxiliary power source is connected to an

aircraft AC power operating at a frequency of 400 Hz.

The use of accessories, transducers, and cables other than those specified in this manual and

related X Series option manual inserts may result in increased emissions or decreased immunity

of the X Series.

Perform functional test of internal paddles prior to use.

Do not use or place the unit in service if the Ready For Use indicator (at the upper right of the

front panel) displays a red circle with a line through it.

Carefully route patient cables to avoid tripping over them, or inadvertently pulling the unit onto

the patient.

Always inspect the unit for damage if it has been dropped.

Only authorized personnel should use the Supervisor menus.

If uncertain about the accuracy of any measurement, first check the patient’s vital signs by

alternate means, and then make sure the monitor is functioning correctly.

ECG Monitoring

Implanted pacemakers might cause the heart rate meter to count the pacemaker rate during

incidents of cardiac arrest or other arrhythmias. Dedicated pacemaker detection circuitry may

not detect all implanted pacemaker spikes. Check the patient's pulse; do not rely solely on heart

rate meters. Patient history and physical examination are important factors in determining the

presence of an implanted pacemaker. Pacemaker patients should be carefully observed. See

“Pacemaker Pulse Rejection:” on page A-15 of this manual for disclosure of the pacemaker

pulse rejection capability of this instrument.

Use only ECG electrodes that meet the AAMI standard for electrode performance

(AAMI EC-12). Use of electrodes not meeting this AAMI standard could cause the ECG trace

recovery after defibrillation to be significantly delayed.

Prior to attempting synchronized cardioversion, ensure the ECG signal quality is good and that

sync markers are displayed above each QRS complex.

Do not place electrodes directly over an implanted pacemaker.

The X Series unit detects ECG electrical signals only. It does not detect a pulse (effective

circulatory perfusion). Always verify pulse and heart rate by physical assessment of the patient.

Never assume that the display of a nonzero heart rate means that the patient has a pulse.

Excessive artifact can result due to improper skin preparation of the electrode sites. Follow skin

preparation instructions in Chapter 6: “Monitoring ECG.”

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Warnings

Equipment such as electrocautery or diathermy equipment, RFID readers, electronic article

surveillance (EAS) systems, or metal detectors that emit strong radio frequency signals can

cause electrical interference and distort the ECG signal displayed by the monitor, thereby

preventing accurate rhythm analysis. Ensure adequate separation between such emitters, the

device, and the patient when performing rhythm analysis.

Shock Hazard: Use of accessories, other than those specified in the operating instructions, may

adversely affect patient leakage currents.

Certain line-isolation monitors may cause interference on the ECG display and may inhibit

heart rate alarms.

Monitoring ECG through the paddles may result in inaccurate heart rate display due to artifact.

Defibrillation

The ZOLL X Series can deliver 200 joules of electrical energy. If this electrical energy is not

discharged properly, as described in the this manual, the electrical energy could cause personal

injury or death to the operator or bystander.

To avoid possible damage to the X Series unit, turn off pacing before defibrillating the patient

with a second defibrillator.

After a synchronized cardioversion, the SYNC mode may be cleared after each shock or

disarm. The user may have to reselect (press) the SYNC button after each synchronized

cardioversion shock performed on a patient. In Defib/Pacer Default settings in the Supervisor

Setup menu, the X Series can be configured to remain in the SYNC mode after each

synchronized cardioversion.

Synchronized cardioversion can be performed in the paddle monitoring mode. However, it is

possible that artifact can be produced by the moving paddles, which could cause the

defibrillator to trigger on the artifact. It is recommended that monitoring in leads I, II or III be

used during synchronized cardioversion. Paddle monitoring should not be used for elective

cardioversions procedures.

To avoid stress to the defibrillator or the tester, never attempt to repeatedly charge and

discharge the defibrillator in rapid succession. If a need for repetitive testing arises, allow a

waiting period of at least 2 minutes after every third discharge.

In the SYNC mode, the defibrillator does not discharge without a command signal (R-wave

detection) from the ECG monitor indicated by a SYNC marker on the trace and a flashing

SYNC indicator.

If conductive gel forms a continuous path between the defibrillator electrodes, delivered energy

may be dramatically reduced to zero. In this case, reposition the electrodes to eliminate the

shunting path before attempting additional shocks.

Improper defibrillation technique can cause skin burns. To limit possible skin burns, use only

ZOLL defibrillation gel on paddles, ensure the gel covers the entire paddle surface and press

firmly against patient’s chest.

If a new energy level is selected after the CHARGE button is pushed and while the defibrillator

is charging or charged, the defibrillator will disarm. The CHARGE button will need to be

pressed again to charge to the new energy level.

Prior to defibrillation, disconnect from the patient any medical electronic device that is not

labeled “defibrillation protected.”

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Before charging the defibrillator, verify that the energy selected on the display is the desired

output.

Defibrillation takes priority over external pacing. Should the defibrillator be charged during the

administration of external pacing, the pacer turns off and the defibrillator charges to the

selected energy.

Pacing

Ventricular fibrillation does not respond to pacing and requires immediate defibrillation.

Therefore, the patient’s dysrhythmia must be determined immediately, so that you can employ

appropriate therapy. If the patient is in ventricular fibrillation and defibrillation is successful but

cardiac standstill (asystole) ensues, you should use the pacemaker.

Ventricular or supraventricular tachycardias can be interrupted with pacing, but in an

emergency or during circulatory collapse, synchronized cardioversion is faster and more

certain.

Pulseless electrical activity (PEA) can occur following prolonged cardiac arrest or in other

disease states with myocardial depression. Pacing might then produce ECG responses without

effective mechanical contractions, making other effective treatment necessary.

Pacing can evoke undesirable repetitive responses, tachycardia, or fibrillation in the presence of

generalized hypoxia, myocardial ischemia, cardiac drug toxicity, electrolyte imbalance, or

other cardiac diseases.

Pacing by any method tends to inhibit intrinsic rhythmicity. Abrupt cessation of pacing,

particularly at rapid rates, can cause ventricular standstill and should be avoided.

Noninvasive temporary pacing can cause discomfort of varying intensity, which occasionally

can be severe and preclude its continued use in conscious patients.

Similarly, unavoidable skeletal muscle contraction might be troublesome in very sick patients

and might limit continuous use to a few hours. Erythema or hyperemia of the skin under the

hands-free therapy electrodes often occurs; this effect is usually enhanced along the perimeter

of the electrode. This reddening should lessen substantially within 72 hours.

There have been reports of burns under the anterior electrode when pacing adult patients with

severely restricted blood flow to the skin. Prolonged pacing should be avoided in these cases

and periodic inspection of the underlying skin is advised.

There are reports of transient inhibition of spontaneous respiration in unconscious patients with

previously available units when the anterior electrode was placed too low on the abdomen.

The pacing rate determination can be adversely affected by artifact. If the patient’s pulse and

the heart rate display are significantly different, external pacing pulses may not be delivered

when required.

Artifact and ECG noise can make R-wave detection unreliable, affecting the HR meter and the

demand mode pacing rate. Always observe the patient closely during pacing operations.

Consider using asynchronous pacing mode if a reliable ECG trace is unobtainable.

Transcutaneous pacing should not be used to treat V FIB (ventricular fibrillation). In cases of

V FIB, immediate defibrillation is advised.

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Warnings

Transcutaneous pacing may cause discomfort ranging from mild to severe, depending on the

patient’s tolerance level, muscle contractions and electrode placement. In certain cases,

discomfort may be decreased by slightly relocating the pacing pads.

It is important to monitor the patient closely to verify that both mechanical and electrical

capture are occurring. Electrical capture can be verified by observing the presence of a large

ectopic beat after the pacing pulse is delivered. The size and morphology of the beat are

dependent on the patient. In some instances the beat may appear as a relatively normal looking

QRS pulse. Mechanical capture can be verified by checking for signs of increased blood flow

i.e., reddening of the skin, palpable pulses, increased blood pressure, etc. Continuously observe

the patient during pacing administration, to insure capture retention. Do not leave the patient

unattended when administering external pacing therapy.

Warning!

This device can only be used for external pacing of patients and cannot be used for

internal pacing. Do not connect internal pacing lead wires to the X Series defibrillator.

CPR

The CPR monitoring function is not intended for use on patients under 8 years of age.

Place the patient on a firm surface before performing CPR.

The patient must be motionless during CPR for accurate CPR measurements.

Pulse Oximeter

Keep the ZOLL finger probe clean and dry.

SpO2 measurements may be affected by certain patient conditions: severe right heart failure,

tricuspid regurgitation or obstructed venous return.

SpO2 measurements may be affected when using intravascular dyes, in extreme

vasoconstriction or hypovolemia or under conditions where there is no pulsating arterial

vascular bed.

SpO2 measurements may be affected in the presence of strong EMI fields, electrosurgical

devices, IR lamps, bright lights, improperly applied sensors; the use of non-ZOLL sensors, or

damaged sensors; in patients with smoke inhalation, or carbon monoxide poisoning, or with

patient movement.

Tissue damage can result if sensors are applied incorrectly, or left in the same location for an

extended period of time. Move sensor every 4 hours to reduce possibility of tissue damage.

Do not use any oximetry sensors during MRI scanning. MRI procedures can cause conducted

current to flow through the sensors, causing patient burns.

Do not apply SpO2 sensor to the same limb that has an NIBP cuff. The SpO2 alarm may sound

when the arterial circulation is cut off during NIBP measurements, and may affect SpO2

measurements.

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In some instances, such as obstructed airway, the patient's breathing attempts may not produce

any air exchange. These breathing attempts can still produce chest size changes, creating

impedance changes, which can be detected by the respiration detector. It is best to use the pulse

oximeter whenever monitoring respirations, to accurately depict the patient's respiratory

condition.

Noninvasive Blood Pressure

Only a physician can interpret pressure measurements.

Blood pressure measurement results may be affected by the position of the patient, his or her

physiological condition and other factors.

Substitution of a component different from that supplied by ZOLL (e.g., cuff, hoses, etc.) may

result in measurement error. Use only ZOLL-approved cuffs and hoses. To avoid the risk of

intravenous line misconnection and possible introduction of air into a patient’s blood, do not

modify the NIBP system or hoses with Luer Lock adapters.

Do not use a blood pressure cuff on the limb being used for IV infusion or for SpO2 monitoring.

Accurate pressure readings may not be achieved on a person experiencing arrhythmias,

shaking, convulsions or seizures. Medication may also affect pressure readings. The correct

size cuff is essential for accurate blood pressure readings.

Blood pressure hoses must be free of obstructions and crimps.

If the patient’s cuff is not at heart level, an error in measurement may result.

When monitoring blood pressure at frequent intervals, observe the cuffed extremity of the

patient for signs of impeded blood flow.

Do not monitor one patient’s NIBP while monitoring another patient’s ECG.

Blood pressure measurement may be inaccurate if taken while accelerating or decelerating in a

moving vehicle.

If an NIBP measurement result is questionable or “motion” indication is displayed, repeat the

measurement. If the repeated measurement result is still questionable, use another blood

pressure measurement method.

Do not use the NIBP on cardiopulmonary bypass patients.

IBP

To ensure compatibility and electrical safety, accessory pressure sensors should comply with

ANSI/AAMI BP-22 and IEC 60601-2-34 for IBP or ANSI/AAMI NS28 for ICP.

Follow instructions supplied with any accessory pressure sensor regarding calibration and

removal of trapped air.

Avoid touching metal parts of any transducer while it is in contact with the patient.

Do not reuse any components that are labeled for single use only.

Transducers should be rated to withstand an accidental drop of at least a meter onto a hard

surface.

Transducers that are subject to immersion in liquids should be rated as watertight.

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Warnings

CO2

During MRI scanning, the monitor must be placed outside the MRI suite. When the monitor is

used outside the MRI suite, EtCO2 monitoring can be implemented using a long FilterLine®

which permits placement of the monitor outside the MRI suite.

When using the monitor with anesthetics, nitrous oxide or high concentrations of oxygen,

connect the gas outlet to a scavenger system.

Use only Oridion Microstream CO2 sampling lines.

Microstream CO2 sampling lines are labeled for single patient use only. Do not reuse sampling

lines.

If using the CO2 Monitor for extended critical care, replace the airway adapter every 24 hours

or when it becomes occluded.

CO2 readings and respiratory rate can be affected by sensor application errors, certain ambient

environmental conditions, and certain patient conditions.

Respiration

Do not operate the X Series with any other monitor with respiration measurements on the same

patient. The two devices could affect the respiration accuracy.

The device should not be used as an apnea monitor.

Ferromagnetic Equipment

Biomedical equipment and accessories, such as ECG electrodes, cables, and oximeter probes

contain ferromagnetic materials. Ferromagnetic equipment must not be used in the presence of

high magnetic fields created by magnetic resonance imaging (MRI) equipment.

The large magnetic fields generated by an MRI device can attract ferromagnetic equipment

with an extremely violent force, which could cause serious personal injury or death to persons

between the equipment and the MRI device.

Battery

Although the device can operate with auxiliary power alone, ZOLL strongly recommends that

you operate the unit with a battery installed at all times. Operating the unit with a battery

provides a backup in case of AC power shortage, and results in faster charge time. The battery

can be automatically recharged while it is installed in the unit. Keep a fully charged spare

battery pack with the defibrillator at all times.

Test battery packs regularly. A battery that does not pass the ZOLL charger’s capacity test

might cause the X Series unit to shut down unexpectedly.

If the Low Battery indication occurs at any time during operation, immediately replace the

battery pack.

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CHAPTER 1 GENERAL INFORMATION

If the LOW BATTERY icon appears, plug the X Series unit into a power source or install a fully

charged battery pack. When the warning low battery shutdown prompt appears, immediately

replace the battery pack with a fully charged pack or plug the X Series unit into a power source,

as unit shut down due to a low battery condition is imminent.

If mistreated, a battery pack might explode. Do not disassemble a battery pack or dispose of it

in fire.

Operator Safety

The X Series can deliver 200 joules of electrical energy. If this electrical energy is not

discharged properly, as described in this manual, the electrical energy could cause personal

injury or death to the operator or bystanders.

Do not use the X Series in the presence of oxygen-rich atmospheres, flammable anesthetics, or

other flammable agents (such as gasoline). Using the unit in such environments might cause an

explosion.

Do not use the unit near or within standing water. Electrical safety might be compromised when

the defibrillator is wet.

Never discharge the unit with the defibrillation electrodes or paddles shorted together or in

open air.

Do not discharge the defibrillator except as indicated in the instructions. Discharge the

defibrillator only when defibrillation electrodes or paddles are properly applied to the patient.

To avoid risk of electrical shock, do not touch the gelled area of the hands-free therapy

electrodes during pacing or defibrillation.

To avoid risk of electrical shock, do not allow electrolyte gel to accumulate on hands or paddle

handles.

To avoid risk of electrical shock, do not allow patient connectors to contact other conductive

parts, including earth.

For defibrillation using paddles, use only high-conductivity electrolyte gel specified for such

use by the manufacturer.

When using paddles for defibrillation, use your thumbs to operate the SHOCK buttons. Doing

so avoids inadvertent shock to the operator.

The use of accessory equipment that does not comply with the equivalent safety requirements

of the X Series defibrillator could reduce the level of safety of the combined system. When

choosing accessory equipment, consider the following:

• Use of the accessory in the patient vicinity.

• Evidence that the safety certification of the accessory has been performed in accordance

with the appropriate IEC (EN) 60601-1 and/or IEC (EN) 60601-1-1 harmonized national

standards.

Always check that the equipment functions properly and is in proper condition before use.

Disconnect all electro-medical equipment that is not defibrillation-protected from the patient

prior to defibrillation.

Before discharging the defibrillator, warn everyone to STAND CLEAR of the patient.

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Warnings

Do not touch the bed, patient, or any equipment connected to the patient during defibrillation.

A severe shock can result. To avoid hazardous pathways for the defibrillation current, do not

allow exposed portions of the patient's body to touch any metal objects, such as a bed frame.

To avoid risk of electrical shock, do not allow printer to come into contact with other conducive

parts, such as equipment connected to the USB port.

Patient Safety

Inappropriate defibrillation or cardioversion of a patient (for example, with no malignant

arrhythmia) may precipitate ventricular fibrillation, asystole, or other dangerous arrhythmias.

Defibrillation without proper application of electrodes or paddle electrolyte gel might be

ineffective and cause burns, particularly when repeated shocks are necessary. Erythema or

hyperemia of the skin under the paddles, or electrodes often occurs; this effect is usually

enhanced along the perimeter of the paddles or electrodes. This reddening should diminish

substantially within 72 hours.

This equipment should be connected to only one patient at a time.

Use only OneStep Pediatric electrodes to defibrillate patients under 8 years of age. Use of adult

electrodes, or pediatric electrodes other than OneStep Pediatric electrodes, can result in the

delivery of excessive energy doses.

Neonatal and pediatric defibrillation energy level settings should be based on site-specific

clinical protocols.

To ensure patient safety, do not place the monitor in any position that might cause it to fall on

the patient.

To ensure patient safety, connect the X Series only to equipment with circuits that are

electrically isolated.

Use only high-quality ECG electrodes. ECG electrodes are for rhythm acquisition only; you

cannot use ECG electrodes for defibrillation or pacing.

Do not use therapy or ECG electrodes if the gel is dried, separated, torn or split from the foil;

patient burns may result from using such electrodes. Poor adherence and/or air pockets under

therapy electrodes can cause arcing and skin burns.

Check the expiration date on the electrode packaging. Do not use electrodes after their

expiration date.

Excessive body hair or wet, diaphoretic skin can inhibit electrode coupling to the skin. Clip

excess hair and dry any moisture from the area where an electrode is to be attached.

Therapy electrodes should be replaced periodically during continuous pacing. Consult

electrode directions for proper replacement instructions.

Prolonged pacing (more than 30 minutes), particularly in neonates or adults with severely

restricted blood flow, may cause burns. Periodically inspect the skin under the electrodes.

Carefully route the patient cables away from the patient’s neck to reduce the possibility of

patient entanglement or strangulation.

To avoid electrosurgery burns at monitoring sites, ensure proper connection of the

electrosurgery return circuit so that a return path cannot be made through monitoring electrodes

or probes.

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CHAPTER 1 GENERAL INFORMATION

During electrosurgery, observe the following guidelines to minimize electrosurgery unit (ESU)

interference and provide maximum operator and patient safety:

• Keep all patient monitoring cables away from earth ground, ESU knives, and ESU return

wires.

• Use electrosurgical grounding pads with the largest practical contact area.

Always ensure proper application of the electrosurgical return electrode to the patient.

Check electrical leakage levels before use. Leakage current might be excessive if more than one

monitor or other piece of equipment is connected to the patient.

Cautions

If the unit is to be stored longer than 30 days, remove the battery pack.

Do not sterilize the defibrillator, or its accessories unless the accessories are labelled as

sterilizable.

Do not immerse any part of the defibrillator in water.

Do not use the defibrillator if excessive condensation is visible on the device. Wipe only the

outside with a damp cloth.

Do not use ketones (such as acetone or MEK) on the defibrillator.

Avoid using abrasives (including paper towels) on the display window.

To achieve the specified level of protection against spilled or splashed liquids, thoroughly dry

all exposed surfaces of this device prior to operation or connections to auxiliary power.

If liquids enter the device connectors, remove all liquid from the connectors and allow the

device to dry thoroughly prior to use.

Grounding reliability can be achieved only when the equipment is connected to a receptacle

marked “HOSPITAL ONLY,” “HOSPITAL GRADE,” or equivalent. If the grounding integrity

of the line cord or ac receptacle is questionable, operate the defibrillator using battery power

only.

Do not connect to an electrical outlet controlled by a wall switch or dimmer.

To protect the unit from damage during defibrillation, for accurate ECG information, and to

protect against noise and other interference, use only internal current-limiting ECG cables

specified or supplied by ZOLL.

For continued safety and EMI performance, use only the line cord supplied by ZOLL.

Electrical installation of the room or the building in which the monitor is to be used must

comply with regulations specified by the country in which the equipment is to be used.

Dispose of battery packs in accordance with national, regional and local regulations. Battery

packs should be shipped to a reclamation facility for recovery of metal and plastic compounds

as the proper method of waste management.

Do not place the device where the controls can be changed by the patient.

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Restarting the Defibrillator

Restarting the Defibrillator

Certain events require the X Series products to be restarted after they shut off or become

inoperative (for example, when the battery runs down and the unit shuts off).

In such a case, always try to restore defibrillator operation as follows:

1. Press the power switch on the top of the unit to turn it off.

2. If necessary, replace a depleted battery with a fully charged pack, or connect the defibrillator

to auxiliary power.

3. Press the power switch on the top of the unit to turn it back on.

This sequence is necessary to restart the defibrillator and can also be used to clear some fault

messages when immediate use of the defibrillator is required.

If the X Series unit is powered off for less than 2 minutes, all patient monitoring parameter

settings will be retained. If the unit has been powered off for at least two minutes, it will be

considered a New Patient and all of the patient-specific parameters (alarm limits, defibrillator

energy, etc.) will be reset to their default values.

FDA Tracking Requirements

U.S. Federal Law (21 CFR 821) requires the tracking of defibrillators. Under this law, owners

of this defibrillator must notify ZOLL Medical Corporation if this product is

• received

• lost, stolen, or destroyed

• donated, resold, or otherwise distributed to a different organization

If any such event occurs, contact ZOLL Medical Corporation in writing with the following

information:

1. Originator's organization – Company name, address, contact name, and contact phone

number

2. Model number, and serial number of the defibrillator

3. Disposition of the defibrillator (for example, received, lost, stolen, destroyed, distributed to

another organization), new location and/or organization (if known and different from

originator’s organization) – company name, address, contact name, and contact phone

number

4. Date when the change took effect

Please address the information to:

ZOLL Medical Corporation

Attn: Tracking Coordinator

269 Mill Road

Chelmsford, MA 01824-4105

Fax:

(978) 421-0025

Telephone: (978) 421-9655

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CHAPTER 1 GENERAL INFORMATION

Notification of Adverse Events

As a health care provider, you may have responsibilities under the Safe Medical Devices Act

(SMDA), for reporting to ZOLL Medical Corporation, and possibly to the FDA, the occurrence

of certain events.

These events, described in 21 CFR Part 803, include device-related death and serious injury or

illness. In addition, as part of our Quality Assurance Program, ZOLL Medical Corporation

requests to be notified of device failures or malfunctions. This information is required to ensure

that ZOLL Medical Corporation provides only the highest quality products.

Software License

Note:

Read this Operator’s Guide and License agreement carefully before operating any of

the X Series products.

Software incorporated into the system is protected by copyright laws and international

copyright treaties as well as other intellectual property laws and treaties. This software is

licensed, not sold. By taking delivery of and using this system, the Purchaser signifies

agreement to and acceptance of the following terms and conditions:

1. Grant of License: In consideration of payment of the software license fee which is part of

the price paid for this product ZOLL Medical Corporation grants the Purchaser a nonexclusive license, without right to sublicense, to use the system software in object-code

form only.

2. Ownership of Software/Firmware: Title to, ownership of and all rights and interests in the

system software and all copies thereof remain at all times vested in the manufacturer, and

Licensors to ZOLL Medical Corporation and they do not pass to purchaser.

3. Assignment: Purchaser agrees not to assign, sublicense or otherwise transfer or share its

rights under the license without the express written permission of ZOLL Medical

Corporation.

4. Use Restrictions: As the Purchaser, you may physically transfer the products from one

location to another provided that the software/firmware is not copied. You may not disclose,

publish, translate, release or distribute copies of the software/firmware to others. You may

not modify, adapt, translate, reverse engineer, decompile, crosscompile, disassemble or

create derivative works based on the software/firmware.

NO IMPLIED LICENSE

Possession or purchase of this device does not convey any express or implied license to use the

device with replacement parts which would, alone, or in combination with this device, fall

within the scope of one or more of the patents relating to this device.

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Service

Service

The X Series only requires recalibration of the CO2 module. Service is required after 20,000

hours of use of the CO2 module. Appropriately trained and qualified personnel should,

however, perform periodic tests of the defibrillator functionality to verify proper operation.

If a unit requires service, contact the ZOLL Technical Service Department.

For customers In the U.S.A.

For customers outside the U.S.A.

Telephone:

1-800-348-9011

1-978-421-9655

Call the nearest authorized ZOLL Medical Corporation

representative.

Fax:

1-978-421-0010

To locate an authorized service center, contact the

International Sales Department at

ZOLL Medical Corporation

269 Mill Road

Chelmsford, MA 01824-4105

Telephone: 1-978-421-9655

When requesting service, please provide the following information to the service

representative:

•

•

•

•

•

•

Unit serial number

Description of the problem

Department using the equipment and name of the person to contact

Purchase order to allow tracking of loan equipment

Purchase order for a unit with an expired warranty

Sample ECG or other stripcharts demonstrating the problem (if available and applicable),

less any confidential patient information.

Returning a unit for service

Before sending a unit to the ZOLL Technical Service Department for repair, obtain a service

request (SR) number from the service representative.

Remove the battery pack from the unit. Pack the unit with its cables and battery in the original

containers (if available) or equivalent packaging. Be sure the assigned service request number

appears on each package.

For customers

Return the unit to

In the U.S.A.

ZOLL Medical Corporation

269 Mill Road

Chelmsford, MA 01824-4105

Attention: Technical Service Department (SR number)

Telephone: 1-800-348-9011

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CHAPTER 1 GENERAL INFORMATION

For customers

Return the unit to

In Canada

ZOLL Medical Canada Inc.

1750 Sismet Road, Unit #1

Mississauga, ON L4W 1R6

Attention: Technical Service Department (SR number)

Telephone: 1-866-442-1011

In other locations

The nearest authorized ZOLL Medical Corporation representative.

To locate an authorized service center, contact the International Sales

Department at

ZOLL Medical Corporation

269 Mill Road

Chelmsford, MA 01824-4105

Telephone: 1-978-421-9655

The ZOLL Serial Number

Each ZOLL product displays a serial number that contains information about that product.

From left to right, ZOLL serial numbers are structured as follows:

• A two-character product code

• A three-character date-of-manufacture code

• A product serial number of six or more alphanumeric characters

The first two characters of the date-of-manufacture code give the last two digits of the year (for

example, “06” appears for products manufactured in 2006). The last character of the date-ofmanufacture code gives the month in which the product was manufactured. The month appears

in the form of a single alphanumeric character: “A” for January, “B” for February, “C” for

March, and so on through “L” for December.

The product serial number is a unique set of alphanumeric characters that ZOLL assigns to each

individual unit.

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Page 41

Chapter 2

Product Overview

Defibrillator Controls and Indicators

3

1

2

SHOCK

1

2

3

0!#%2

¸

6

4

7

6

6

5

8

9

10

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CHAPTER 2 PRODUCT OVERVIEW

Table 2-1.

X Series Unit Features

Item

Description

1

Handle

Integrated carrying handle.

2

Front panel

Includes the display screen and primary controls.

3

Microphone (optional)

Records audio activity in the vicinity of the X Series unit.

4

Speaker

Emits R-wave detection beeps and alarm tones.

5

Paper Compartment

Holds the paper for the printer.

6

Patient connectors

For details, refer to “Patient Cables and Connectors” on

page 2-7.

7

USB device connector

For connecting the X Series defibrillator to a USB device.

For details, refer to “Transferring Data to a USB Device” on

page 21-4“.

8

Battery compartment

Holds a rechargeable lithium ion battery pack.

9

Auxiliary power connector

For connecting the device to an auxiliary power adapter.

10

Dock connector

For connecting the device to a docking station.

The Front Panel

The front panel of the X Series device includes the display screen, quick access keys, battery

and auxiliary power indicators, Ready For Use (RFU) indicator, and the defibrillation front

panel buttons: Pacer, Analyze, Energy Select, Charge, and Shock (

). See Figure 2-1.

Refer to Table 2-2 on page 2-3 for information about the controls and indicators.

Microphone (optional)

Visual Alarm Indicators

Power button

Display screen

RFU indicator

Silence/reset

Display

Seven quick

access keys

Navigation keys

Snapshot

NIBP

SHOCK

1

Auxiliary power LED

Shock

¸

Charge

Pacer

Analyze

2–2

3

0!#%2

Battery charge LED

Figure 2-1.

2

Energy Select

X Series Front Panel

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Defibrillator Controls and Indicators

Table 2-2.

X Series Controls and Indicators

Control or Indicator

Description

Display screen

Shows therapeutic settings, physiological waveforms and other

information for each monitored parameter, messages, time, and quick

access key labels.

Quick access keys

Seven buttons control different functions of the unit. Labels for the quick

access keys appear on the monitor display to the right of each key.

Auxiliary power LED

Illuminated when the unit is plugged in to an auxiliary power adapter.

Battery charge LED

Indicates battery status:

Steady yellow:

Steady green:

Alternating green and yellow:

Battery is charging.

Battery is charged.

The charge state cannot be determined

or a battery charging fault has been

detected.

No light:

Battery is not installed.

Visual alarm

indicators

Red, yellow, and green lights located on the top of the unit that flash on

and off when the unit is powered up and are used to indicate a patient

alert, equipment alert, and data transfer.

Pacer button

Displays pacer settings window to start/stop pacing activity or change

the rate, output, or mode settings.

PACER

ANALYZE button

Displays in Manual mode only. Initiates ECG analysis to determine

whether or not a shockable rhythm is present.

ENERGY SELECT

buttons

Two sets of up-down arrow buttons control the selection of defibrillator

energy; one set is located on the front panel and the other set is located

on the STERNUM paddle.

CHARGE Button

Charges the defibrillator to the selected energy. In addition to the

CHARGE button on the front panel, there is one located on the APEX

paddle handle.

Shock Button

The front panel Shock button is only active when using hands-free

therapy electrodes or internal defibrillation paddles without a discharge

button. The Shock button illuminates when the device is charged and

ready.

To discharge the defibrillator when using paddles (internal or external)

with discharge buttons, press and hold the SHOCK buttons on the

paddles.

NIBP button

Starts/stops an NIBP measurement.

Snapshot button

Records 24 seconds of numeric and waveform data.

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CHAPTER 2 PRODUCT OVERVIEW

Table 2-2.

X Series Controls and Indicators (continued)

Control or Indicator

Description

Navigation keys

The up (clockwise) arrow will cause the cursor to travel in an

upward direction if the cursor is being used to navigate through a

vertical list or in a clockwise direction if the cursor is being used to

navigate around the full screen. Likewise, the down (counterclockwise)

arrow will cause the cursor to travel in a downward direction if the cursor

is being used to navigate through a vertical list or in a counterclockwise

direction if the cursor is being used to navigate around the full screen.

The up (clockwise) and down (counterclockwise) arrows may also be

used to modify parameter settings.

The Select button acts based on what is highlighted.

Display/Home button

Cycles through three available display modes or functions as a Home

button when in a menu.

Silence/Reset button

Silences the current alarm tone for 90 seconds or resets a silenced

alarm tone.

RFU indicator

Shows the status of the unit, based on its most recent readiness check.

Ready

Do Not Use

A red circle with a line through it indicates that the unit’s readiness has

been compromised and that it may not be ready for therapeutic use.

Power button

Located on the top of the unit, this button turns the unit on and off.

Microphone (optional)

Records audio activity in the vicinity of the X Series unit.

Charge Indicator Light

(not shown)

Located on the APEX paddle, this light turns on when the defibrillator is

charged and ready.

Display Screen

The front panel includes a color display which shows:

• Date and time

• Patient mode

• Battery status indicator

• Time elapsed (since unit was turned on)

• Quick access keys

• Waveform source

• Color-coded waveforms and ECG lead identifiers

• SpO2 numeric data

• Heart rate numeric data

• Respiration rate numeric data

• Temperature numeric data

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Defibrillator Controls and Indicators

• Non-invasive blood pressure numeric data

• EtCO2 numeric data

• Invasive pressure numeric data

• The selected energy, charging status, and delivered energy for defibrillation and

synchronized cardioversion

• The output current and stimulus rate for pacing

• Messages and prompts

Figure 2-2 shows the layout of parameter values, waveforms, system data, and quick access key

labels.

Date and time

06/06/2011

Status queue

Patient mode

12:34:56

Some

alarm

limits

disabled.

EtCO2Check

SpO2

Low Alarm

Sensor

Battery status

Adult

Time elapsed

00:17:43

Message

I, II,

III...

II

1 cm/mV

12

CO2

Quick

access

keys

Waveform

R

SYNC

HR

bpm NIBP

80 121

ºF

T1

98.6

79

Heart rate

NIBP data

mmHg CO2

Figure 2-2.

38

(96)

Current temp

mmHg SpO2

BR

%

SpO2 data

97

12

CO2 data

Respiration rate

X Series Display Screen

Color coding

To differentiate information for various parameters, the unit displays each type of information

in a specific user-configurable color.

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CHAPTER 2 PRODUCT OVERVIEW

Battery Status and Auxiliary Power Indicators

The battery status indicator displays various battery icons to indicate the approximate

remaining unit run time based on the charged state of the battery. Additionally, these icons

provide indications of the status of the battery connection and communication with the unit.

The auxiliary power indicator indicates that the unit is being powered by the auxiliary power

adapter.

Note:

Upon powering up the X Series unit, the battery capacity will be displayed within

approximately 15 seconds under normal conditions. Under some circumstances, such

as activating the defibrillator immediately after the unit is turned on, the battery icon

may display less than one hour battery capacity for up to two minutes after exiting the

defibrillation mode.

Icon

Low

Status

Indication/Action

Auxiliary power adapter is

connected

The unit is being powered by the

auxiliary power adapter.

No battery detected

Either there is no battery in the unit

while it is being powered by the

auxiliary power adapter, or the

device cannot detect that the

battery is connected.

Low battery capacity

Replace the battery soon.

Communication failure

The unit is unable to establish

communication with the battery

and the battery capacity is

unknown. Check the battery

contacts.

Battery fault

A battery fault has been detected.

Replace the battery.

Battery Level 1

The battery has less than one hour

of remaining battery capacity.

Battery Level 2

The battery has greater than one

hour of remaining battery capacity.

Battery Level 3

The battery has greater than two

hours of remaining battery

capacity.

Battery Level 4

The battery has greater than three

hours of remaining battery

capacity.

Battery Level 5

The battery is fully charged.

1:00+

2:00+

3:00+

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Defibrillator Controls and Indicators

Patient Cables and Connectors

The left and right sides of the unit include sets of connectors for patient cables.

Note:

The SPO2, NIBP, CO2, Temperature, and IBP functions are optional. If your unit does

not include these options, it does not have the applicable connectors.

ECG

SpO2

NIBP

CO2

CO2

Exhaust

Figure 2-3.

Patient Cable Connectors on Left Side of Unit

USB

MFC

Temp

IBP

Figure 2-4.

9650-001355-01 Rev. H

Patient Cable Connectors on Right Side of Unit

X Series Operator’s Guide

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Page 48

CHAPTER 2 PRODUCT OVERVIEW

Connector

Description

ECG

For connecting 3- or 5-lead ECG cable (12-lead monitoring is

optional).

SpO2

For connecting Masimo SpO2/CO cable.

NIBP

For connecting NIBP hose.

CO2

For connecting CO2 sampling line.

Temp

For connecting temperature probe(s).

Multifunction Cable (MFC)

For connecting paddles or ZOLL hands-free therapy and pacing

electrodes.

USB

For connecting the X Series defibrillator to a USB device.

IBP

For connecting IBP cable(s).

Multifunction Cable (MFC)

The unit ships with an MFC that is used to defibrillate the patient. Any other cables that ship

with your unit depend on the options you have purchased.

Figure 2-5.

MFC

Inserting MFC into Unit

Plug the MFC connector into the therapy input connector on the right side of the unit. Push the

connector in with the arrows aligned. The connector will click when it locks into place.

1. Insert MFC into unit.

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2. Connector is locked

into place.

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Defibrillator Controls and Indicators

Removing MFC from Unit

Twist the connector to the left to unlock it, and pull out the MFC connector.

1. Twist MFC connector

to the left.

2. Pull out connector.

OneStep Cable (optional)

The OneStep™ cable is used with OneStep electrodes for ECG monitoring and for use with

Real CPR Help.

Figure 2-6.

OneStep Cable

When connecting a OneStep electrode to the OneStep cable, push the two connectors together

until the latch clicks, as shown.

Latch

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CHAPTER 2 PRODUCT OVERVIEW

When disconnecting the OneStep electrode and OneStep cable, press down the latch with your

thumb as shown.

Latch

External Paddles

Paddles are defibrillation-proof Type BF equipment.

The external paddles on the X Series device are used for defibrillation and synchronized

cardioversion.

Caution

You cannot use paddles for external transcutaneous pacing.

Attaching the MFC cable

Attach the MFC from the X Series unit to the connector at the base of the APEX paddle.

1. Align MFC as shown.

Figure 2-7.

2. Insert MFC into APEX handle.

Attaching the MFC to the APEX Paddle

MFC connected to

APEX paddle

MFC Connected to

APEX Paddle

Figure 2-8.

2–10

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Defibrillator Controls and Indicators

If you need to detach the MFC from the APEX paddles, push the RELEASE button (see Figure

2-11) in the direction of the arrow and unplug the MFC.

Attaching the OneStep Cable

When connecting a OneStep electrode to the OneStep cable, push the two connectors together

until the latch clicks, as shown.

Latch

When disconnecting the OneStep electrode and OneStep cable, press down the latch with your

thumb as shown.

Latch

When attaching the OneStep cables to paddles, attach the OneStep cable from the X Series unit

to the connector at the base of the apex paddle.

1. Align OneStep cable as shown.

Figure 2-9.

9650-001355-01 Rev. H

2. Insert OneStep cable into APEX paddle.

Attaching the OneStep Cable to the APEX Paddle

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CHAPTER 2 PRODUCT OVERVIEW

OneStep cable connected

to APEX paddle

Figure 2-10.

OneStep Cable Connected to APEX Paddle

If you need to detach the OneStep cable from the APEX paddles, push the RELEASE button

(see Figure 2-11) in the direction of the arrow and unplug the OneStep cable.

Refer to Chapter 15, "Manual Defibrillation" before using paddles for defibrillation. The

paddles include controls for selecting defibrillation energy, charging, and delivering a shock.

SHOCK

Buttons

RECORDER

Button

ENERGY

SELECT

Buttons

CHARGE

Button

Charge Ready

Indicator

Connector

and RELEASE

button for

MFC or

OneStep cable

STERNUM Paddle

Figure 2-11.

2–12

APEX Paddle

External Paddles

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9650-001355-01 Rev. H

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Defibrillator Controls and Indicators

Pediatric-size electrodes are built in to the paddle assembly beneath the standard electrode

plates. The user must manually adjust energy settings to pediatric levels consistent with their

institution’s protocols.

PEDI button

To expose the pediatric plate, press the PEDI button at

the top of the paddle, then slide the Adult plate upward.

Before replacing the Adult plate, be sure to clean the

pediatric plate and surrounding area thoroughly.

Slide the Adult plate onto the paddle until it locks into

place.

Figure 2-12.

Note:

Pediatric Plate

The X Series defibrillator also supports ZOLL autoclavable internal handles for use

during open chest defibrillation procedures.

AC Auxiliary Power Adapter

The AC auxiliary power adapter is used as backup power to operate the X Series unit. When it

is connected to the unit, it powers the unit and charges the battery that is installed inside it.

When the power cord is plugged in and the auxiliary power connector is inserted into the back

of the X Series unit, the auxiliary power LED on the front panel illuminates and the auxiliary

power icon (

) displays at the top of the display screen. See “Connecting the AC Auxiliary

Power Adapter or DC Auxiliary Power Supply” on page 2-15 for instructions on connecting the

adapter to the X Series unit.

Figure 2-13.

Caution

AC Auxiliary Power Adapter

To ensure continuous operation, always keep a battery installed in the device that is being

powered by the AC Auxiliary Power Adapter.

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CHAPTER 2 PRODUCT OVERVIEW

DC Auxiliary Power Supply (optional)

The DC auxiliary power supply is used as backup power to operate the X Series unit. When it is

connected to the unit, it powers the unit and charges the battery that is installed inside it. When

the vehicle power input plug is connected to vehicle power and the power supply output

connector is inserted into the back of the X Series device, the auxiliary power LED on the front

panel illuminates and the auxiliary power icon (

) displays at the top of the display screen.

Vehicle Power Input Plug

Power Supply

Output Connector

Figure 2-14.

Warning!

DC Auxiliary Power Supply

Do not connect the DC Auxiliary Power Supply to any power source other than DC

voltage, within the range 12-24 VDC.

Do not perform any unauthorized modification to the DC Auxiliary Power Supply.

Caution

To prevent heat buildup while in use, place the DC Auxiliary Power Supply in a location that

allows unrestricted air circulation.

When the DC Auxiliary Power Supply is in use, assess electromagnetic compatibility with

surrounding devices.

To ensure continuous operation, always keep a battery installed in the device that is being

powered by the DC Auxiliary Power Supply.

Connecting the DC Auxiliary Power Supply to a Suitable Vehicle Power Source

Connect the input plug (Hubbell part number HBL7545C) of the DC Auxiliary Power Supply

to the vehicle power source. When the input plug is connected to the vehicle, the brass blade

(red wire) of the Hubbell connector connects to the DC positive (+) vehicle supply terminal,

and the silver blade (black wire) connects to the DC negative (-) vehicle supply terminal.

2–14

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Navigating the Display Screen

Connecting AC Auxiliary Power Adapter or DC Auxiliary Power Supply to X Series Unit

To connect the AC auxiliary power adapter or the DC auxiliary power supply to the X Series

unit, align the white arrow of the auxiliary power connector with the arrow on the input

connector on the back of the unit and push it in. To disconnect the auxiliary power adapter/

power supply, grasp the connector and pull it out.

Figure 2-15.

Connecting the AC Auxiliary Power Adapter or DC Auxiliary Power Supply

Navigating the Display Screen

You can access the X Series functions using the quick access keys that are located on the left

side of the display screen, and the navigation keys that are located on the right side of the front

panel.

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CHAPTER 2 PRODUCT OVERVIEW

Quick Access Keys

The seven quick access keys on the left side of the display screen are an easy way to access the

functionality of the X Series. When you press the last key (left arrow), five more keys are

displayed.

First level keys

Second level keys

I, II,

III...

12

IBP

CO2

R

LOG

SYNC

Table 2-3.

X Series Quick Access Keys

Quick access key

Description

Lead

Selects the ECG input source for the first waveform trace.

I, II,

III...

12 lead

Displays the 12-lead monitoring screen.

12

CO2

Turns CO2 on and off.

Treatment

Displays the current clinical treatment options.

R

Sync

Activates the synchronized cardioversion mode.

SYNC

Print

2–16

Starts or stops a continuous chart print.

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Navigating the Display Screen

Table 2-3.

X Series Quick Access Keys

Quick access key

Description

More/Back

Goes to the next or previous level of quick access keys.

Brightness

Changes the brightness setting -- toggles through high contrast

display (white background), color display (black background), and

night vision goggle (NVG) friendly display.

IBP

Displays IBP setup and zero buttons.

IBP

Alarms

Displays the Limits option to allow the user to view/set all parameter

alarm limits and the alarm suspend button.

Log

Opens the Log Control panel.

LOG

Setup

Displays the Setup menu to allow the user to configure settings such

as ECG, display/volume, printer, trends, operational checklist, and

supervisor.

Treatment Summary

Displays treatment summary cases, which you can print.

Manual Mode

Allows user to change from AED Mode to Manual Mode.

Manual

Mode

Pause

Allows user to Pause the rescue cycle.

Pause

Print Trends

Prints the trends that are displayed in the Trend Summary window.

Print

Trends

Trend Settings

Displays settings for trend display format, trend on interval, and trend

on alarm.

Transfer Log

Transfers the current data in the log to a USB drive.

Clear Log

Deletes the current data in the log.

Acquire

Collects 10 seconds of 12-lead data for print.

12

Stop Acquisition

Stops acquisition of 12-lead data.

STOP

Patient Information

9650-001355-01 Rev. H

Allows you to enter information to accompany 12-lead data: patient

name, age, gender, and ID.

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CHAPTER 2 PRODUCT OVERVIEW

Table 2-3.

X Series Quick Access Keys

Quick access key

Description

Row Up

Allows you to move to the previous row when entering patient

information.

Row

Row Down

Allows you to move to the next row when entering patient information.

Row

12-Lead Review

Reviews all your 12-lead captured data.

12-Lead Review Next

Goes to the next page of the 12-lead snapshot you are reviewing.

Transmit

Transmits 12-lead data.

Exit 12-Lead

Exits the 12-lead monitoring screen.

Exit

12

Stat Set

Sets all alarm limits relative to the patient’s current vital signs.

Stat

Set

Alarm Cancel

Suspends the current alarm.

Limits

Displays the current alarm settings.

Limits

Disarm

Disarm

Disarm

2–18

Safely discharges the defibrillator internally. No energy is delivered to

the patient.

IBP Setup

Brings up the IBP Control Panel for the corresponding channel (P1,

P2, or P3).

IBP Zero

Zeroes the IBP transducer for the corresponding channel (P1, P2, or

P3).

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Page 59

Common Tasks

Navigation Keys

Use the navigation keys (up/clockwise arrow, down/counterclockwise arrow, and select button)

to navigate through windows and make selections.

Using Up/Clockwise and Down/Counterclockwise Arrows

Use the up/clockwise down/counterclockwise arrows to do the following:

• Move clockwise and counterclockwise through the main display windows.

• Move up and down in a window.

• Change parameter settings.

Using the Select Button

Use the Select button to do the following:

• Display the settings window while a parameter is highlighted in the main window.

• Select options from a window.

Display Brightness

The monitor can display in two different brightness modes:

• high contrast with white background (for optimal display in bright sunlight)

• color with black background (numerics and waveforms are easy to read)

Common Tasks

The section contains procedures for the following tasks:

• “Changing the Display Brightness” on page 2-19.

• “Replacing a Battery Pack on the X Series” on page 2-20.

• “Using Treatment Buttons” on page 2-21

Changing the Display Brightness

The following procedure shows how to select the different brightness options.

1. Press the power switch to turn the unit on.

2. Press the Brightness quick access key (

) repeatedly to toggle through the brightness

options until you find your selection.

Note:

Selecting a higher brightness setting (such as 70%) will deplete the battery pack at a

faster rate than when choosing a lower brightness setting (such as 30%). To select the

brightness setting, go to the Setup>Display/Volume>Display Brightness menu to

adjust the display percentage.

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CHAPTER 2 PRODUCT OVERVIEW

Replacing a Battery Pack on the X Series

This section describes how to replace a battery pack on the X Series.

Replacing a Battery Pack on the X Series

To remove a battery pack, use your fingers to grasp and raise the latch and pull the battery pack

out of the compartment.

Figure 2-16.

Removing a Battery Pack

To install a battery pack:

1. Line up the battery so it will slide into the battery well.

2. Push the battery into place.

Figure 2-17.

2–20

Installing a Battery Pack

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Common Tasks

Using Treatment Buttons

Pressing the Treatment quick access key ( R ) causes the unit to display preconfigured buttons

that contain clinical actions. These buttons allow you to add a treatment snapshot (which

itemizes drugs or treatments administered to the patient) to a Treatment Summary Report.You

can do this by selecting Print on Treatment Snapshot from Setup>Supervisor>Printer. The

following is a list of preconfigured treatment buttons:

•

•

•

•

•

•

•

•

•

•

O2

ASA

Nitro

Morph

IV

B Block

Lido

MgSO4

Valium

Sedate

Customizing Treatment Buttons

You can also customize up to 9 treatment buttons by pressing the Setup quick access key (

),

and then selecting Supervisor>Log>Treatment Options. Highlight Define Custom Labels, and

then can customize up to 9 buttons.

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2–22

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Chapter 3

Monitoring Overview

This chapter provides an overview of the X Series unit’s monitoring functions. It describes the

types of vital sign monitoring that X Series provides, and the flexibility that the X Series unit

gives you in displaying a patient’s vital signs information.

X Series Monitoring Functions

The X Series unit provides an array of standard, and optional, monitoring functions, and allows

you to view the vital signs measurements that these functions provide in a variety of formats.

The X Series unit also allows you to set alarm limits for each monitoring function. Should a

patient’s vital signs measurements go outside of these limits, the X Series issues an audible

alarm tone and displays visual alarm indications to alert you.

If the X Series unit is powered off for less than 2 minutes, all patient monitoring parameter

settings are retained. If the X Series unit is powered off for 2 minutes or longer, the unit

operates as if there is a New Patient and all patient-specific parameters (alarm limits,

defibrillator energy, etc.) are reset to their default values.

The X Series unit can monitor the following patient vital signs:

ECG

Heart Rate

Respiration Rate

Temperature

Invasive Pressures (IBP)

Non-invasive Blood Pressure (NIBP)

Capnography (CO2)

• Pulse Oximetry (SpO2)

•

•

•

•

•

•

•

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CHAPTER 3 MONITORING OVERVIEW

ECG

An ECG waveform trace appears at the top of the display area. You can specify that the unit

display the waveform trace of any available ECG source, such as Pads, ECG Leads l, ll, or lll,

and so on, in this area. You can configure the X Series unit to display up to four ECG waveform

traces. In addition to being able to specify the ECG source for each waveform trace, you can

adjust the display scale of those traces to make them easier to view.

Heart Rate

A Heart Rate meter gives the patient’s heart rate in Beats Per Minute (bpm). By default, the X

Series unit derives the heart rate from the patient’s ECG, but can be configured to use other

monitoring functions to derive the patient’s heart rate.

Respiration Rate

A Respiration Rate meter gives the patient’s respiration rate in Breaths Per Minute (br/min).

The X Series unit can be configured to derive the respiration rate from the patient’s ECG or

from the optional CO2 monitoring function.

Temperature

The Temperature (Temp) meter can display temperature measurements from up to two

temperature probes. The X Series unit provides two separate temperature monitoring channels

and, if both are used, displays the monitored temperatures, in degrees F or C, one after the

other, followed by the difference between those temperatures.

Invasive Pressures (IBP)

The X Series unit provides three separate channels for monitoring arterial, venous, or

intracranial pressure using internal probes. The pressure measurements for each pressure

channel appear in a labeled (P1, P2, P3) numeric display.

Non-Invasive Blood Pressure (NIBP)

The X Series unit provides patented Smartcuf motion-tolerant technology for NIBP monitoring.

NIBP monitoring measures the patient’s systolic, diastolic, and mean blood pressure through an

inflatable blood pressure cuff that the X Series unit inflates/deflates. NIBP measurements can

be taken automatically or on-demand by pressing the NIBP button ( ) on the front panel of the

X Series unit. The blood pressure measurements appear in a labeled (NIBP) numeric display.

You can also specify that the X Series unit display non-invasive pressure waveforms in the

waveform trace area.

3-2

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Monitoring Display Options

Capnography (CO2)

CO2 monitoring measures the CO2 concentration in a patient’s exhaled breath (End Tidal

Carbon Dioxide --EtCO2). CO2 monitoring can also measure a patient’s breath rate and the

CO2 concentration in the gasses supplied to intubated patients (Fractional Inspired Carbon

Dioxide -- FiCO2). Since FiCO2 represents the amount of CO2 present during inhalation, it also

serves as an indicator for rebreathing in non-intubated patients. CO2 monitoring can be used for

both intubated and non-intubated patients.

The EtCO2, breath rate, and FiCO2 measurements appear in a labeled (EtCO2) numeric

display. The EtCO2 and FiCO2 measurements can appear as values given in millimeters of

mercury (mmHg). You can also specify that the X Series unit display a CO2 capnogram in the

waveform trace display area.

Pulse Oximetry (SpO2)

Pulse Oximetry monitoring measures the oxygen saturation (SpO2) of arterial blood at a

peripheral site such as a finger or toe. If optional features SpCO and SpMet are installed, it also

monitors carboxyhemoglobin saturation (SpCO), and methemoglobin saturation (SpMet).

SpO2 monitoring determines the ratio of oxygenated hemoglobin to total hemoglobin in arterial

blood and displays this ratio as percent SpO2 in a labeled (SpO2) numeric display. If optional

features SpCO and SpMet are installed, these values alternate and display as SpCO and SpMet

under the SpO2 display. You can also specify that the X Series unit display an SpO2

plethysmograph in the waveform trace display area.

Monitoring Display Options

The X Series unit gives you great flexibility in how you display a patient’s vital signs

information. By pressing the Display/Home button ( ) on the front panel, you can

successively display the patient’s vital signs information in these three windows:

• Waveform Display window, which initially displays an ECG waveform trace and numeric

displays for each monitoring function.

• Trends Status window, which displays a report listing vital signs measurements that the X

Series unit logs automatically, and the primary ECG waveform trace.

• Large Numerics Display window, on which large numeric displays of all vital signs

measurements appear.

The Waveform Display window appears when you power on the X Series unit. Initially, the

Waveform Display window displays a single ECG waveform trace. All other monitored values

appear in numeric display areas at the bottom of the screen:

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CHAPTER 3 MONITORING OVERVIEW

06/06/2011

I, II,

III...

12

CO2

R

SYNC

You can display up to four waveform traces that you specify on the Waveform Display window.

You will determine how to add waveform traces to this window later in this chapter.

Press the Home/Display button when viewing the Waveform Display window, and the unit

displays the Trends Status window. The Trends Status window reports the patient’s vital sign

measurements, which the X Series logs automatically at a configurable interval (see the

following chapter, Trends, for more detailed information about the Trends Status window). The

primary ECG waveform trace appears above the Trends report:

3-4

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Monitoring Display Options

06/06/2011

I, II,

III...

12:34:56

Adult

00:17:43

80

12

NIBP mmHg

121

79

CO2

NIBP Trends

R

bpm

HR

1 cm/mV

II

Time

HR/PR

bpm

SpO2

%

NIBP

mmHg

(96)

RR/BR

br/min

EtCO2 mmHg

SYNC

38

12:30:21

72

97

122/60 (85)

12

12:25:21

80

96

122/60 (85)

14

12:20:21

81

97

122/60 (85)

15

SpO2

12:15:21

73

97

124/63 (86)

13

97

BR

12

T1

%

ºF

98.6

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CHAPTER 3 MONITORING OVERVIEW

Press the Home/Display button when viewing the Trends Status window and the Large

Numerics Display window appears. The patient’s vital signs measurements appear in large

labeled numeric displays; no waveform trace appears on this screen:

06/06/2011

I, II,

III...

12:34:56

HR

CO2

NIBP

SYNC

P1

mmHg

80

121

79

S

00:17:43

SpO2

bpm

12

R

Adult

D

121 79

M

97

38

mmHg EtCO2

(96)

P2

mmHg

BR

12

23:45

(96) mmHg

%

25 9

P3

(15) mmHg

12.4

T1

ºF

98.6

Press the Home/Display button to redisplay the Primary Display window.

Note:

3-6

When the X Series unit is displaying the Defibrillation or Pacing Control panels, the

unit will not allow the display the Large Numerics Display window.

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Page 69

Configuring the Waveform Display

Configuring the Waveform Display

You can display up to four waveform traces on the Waveform Display window. The first

waveform trace always uses an ECG lead as its source (such as Pads or Leads l, ll, or lll, and so

on. The default is Pads). If Pads are not connected, the unit can be configured to

automatically default to another ECG lead for the first trace. As you insert the remaining three

traces, you can specify that the traces use an ECG lead as the waveform source, or that the trace

derive its waveform from other available monitoring functions (such as Resp, CO2, SpO2 or

IBP channels P1, P2, or P3).

If configured, the unit can display four ECG traces on startup, when no other monitoring

devices are attached.

The X Series unit can also cascade a trace onto the adjoining trace area to double the duration

of the trace display.

On the Waveform Display window, to insert a new trace (Insert) or cascade (Cascade) a

displayed trace, highlight and select the trace label above the trace. In the following example,

the unit is configured to cascade the ECG Lead l trace:

06/06/2011

I, II,

III...

II

12

CO2

R

12:34:56

Adult

00:17:43

Source

1 cm/mV

Pads

I

II

III

aVR

aVL

aVF

V

Insert

Cascade

SYNC

HR

bpm NIBP

80 121

79

98.6

T1

Note:

mmHg CO2

mmHg SpO2

38

(96)

ºF

BR

%

97

12

The X Series unit automatically inserts a new waveform when you turn on a parameter

(CO2) or a new sensor signal is present (SPO2, IBP). The X Series unit automatically

removes a waveform when you turn off a parameter or remove a sensor and the unit

displays the resulting equipment alert.

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CHAPTER 3 MONITORING OVERVIEW

When the unit cascades the ECG Lead lI trace, the Waveform Display window appears as

follows:

06/06/2011

I, II,

III...

II

12:34:56

Adult

00:17:43

1 cm/mV

12

CO2

R

SYNC

HR

bpm NIBP

mmHg CO2

80 121

T1

98.6

ºF

38

(96)

79

mmHg SpO2

BR

%

97

12

The following screens demonstrate how to insert two more waveform traces into the window. A

third trace is inserted for ECG lead aVR, and fourth trace for EtCO2 (a capnogram). Notice

that when the third trace is inserted, the numeric displays move to the right side of the window

to allow more room for the waveform traces.

3-8

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Configuring the Waveform Display

Inserting a third waveform trace for ECG lead aVR:

06/06/2011

I, II,

III...

II

12

CO2

R

12:34:56

Adult

00:17:43

Source

1 cm/mV

Pads

I

II

III

aVR

aVL

aVF

V

Insert

Cascade

SYNC

HR

bpm NIBP

80 121

ºF

T1

I, II,

III...

12:34:56

BR

Adult

mmHg SpO2

38

(96)

79

98.6

06/06/2011

mmHg CO2

%

97

12

00:17:43

bpm

HR

II

1 cm/mV

80

12

NIBP mmHg

121

79

CO2

(96)

R

EtCO2 mmHg

SYNC

aVR

1 cm/mV

38

BR

12

SpO2

%

97

T1

ºF

98.6

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CHAPTER 3 MONITORING OVERVIEW

Inserting a capnogram (CO2) into the fourth trace area:

06/06/2011

12:34:56

Adult

00:17:43

bpm

HR

I, II,

III...

Source

1 cm/mV

Pads

I

II

III

aVR

aVL

aVF

V

SpO2

Resp

CO2

P1

P2

P3

aVR

1 cm/mV

Insert

Cascade

Remove

II

12

CO2

R

SYNC

80

NIBP mmHg

121

79

(96)

EtCO2 mmHg

38

BR

12

%

SpO2

97

ºF

T1

98.6

06/06/2011

12:34:56

Adult

00:17:43

bpm

HR

I, II,

III...

II

1 cm/mV

80

12

NIBP mmHg

121

79

CO2

(96)

R

avR

1 cm/mV

EtCO2 mmHg

38

SYNC

60

CO2

0 to 60 mmHg

BR

12

SpO2

%

97

30

0

T1

ºF

98.6

3-10

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Chapter 4

Trends

The X Series unit accumulates a patient’s trend information by logging all monitored vital sign

measurements to memory at a user-configurable interval. It also logs all monitored vital sign

measurements when the following occurs:

• An NIBP measurement is taken and the Trend on NIBP option is on

• You press the Snapshot button (

) on the front panel

• A patient alarm occurs and the Trend on Alarm option is on

The X Series unit can store at least 24 hours of trend information when logged at a 1 minute

trend interval. You can view, print, or save to external memory all logged trend information.

Displaying the Trends Status Window

The X Series unit displays the logged trend information in the Trends status window. Press the

Display/Home button (

) to display the Trends window, the primary ECG trace, and the

small numeric displays for each monitoring function:

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CHAPTER 4 TRENDS

06/06/2011

I, II,

III...

12:34:56

Adult

00:17:43

1 cm/mV

II

12

CO2

NIBP Trends

Time

HR/PR

bpm

SpO2

%

NIBP

mmHg

RR/BR

br/min

12:30:21

72

97

122/60 (85)

12

97

mmHg122/60

CO2(85)

97

(96)124/63 (86)

R

SYNC

12:25:21

HR

12:20:21bpm NIBP

81

80 121

12:15:21

73

38

NavigateHere

HeretotoScroll

Scroll

Through

Trends

Navigate

Through

Trends

T1

98.6

ºF

79

mmHg

15 SpO2

BR

13

%

97

12

Figure 4-1 Trends Status window

The Trends status window displays the logged trend information and the time at which the trend

measurements were logged. While trend measurements are logged to memory at a userconfigurable interval, the Trends status window can display the logged information at an

interval that you specify, with the exception of NIBP measurements, which are logged and

reported at the times they are taken. The Trends status window reports the trends information at

5-minute intervals.

Displaying and Printing Trend Information

To navigate in the Trends status window:

1. Use the navigation keys to highlight the Navigate Here to Scroll Through Trends bar, then

press Select.

2. Press the Up/Down buttons ( ) to scroll through the trend information.

3. To print all trends for the current patient, highlight the NIBP Trends field, then press Select.

Press the Print Trend Summary button in the Trend Settings menu.

4. To select which trends to print for the current patient, press the Log quick access key (

),

then press the Print Trends button (

).

LOG

Print

Trends

4-2

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Changing the Trends Status Window Display

Changing the Trends Status Window Display

By default, the Trends status window displays all logged trend information. It displays the

numeric information for all monitoring functions, which the unit logs at a user-configurable

interval, and when you take NIBP measurements, when a patient alarm occurs, and when you

press

.

LOG

To configure the display of the Trends status window, press (

) and press the Trend Settings

quick access key ( ) to display the Trends Settings control panel. On the Trends Settings

control panel, select Trend Display Format to specify the following monitored vital signs that

appear in the Trends status window:

Trend Format

Vital Signs Displayed

Resp

HR, SpO2, RR, EtCO2, FiCO2

NIBP

HR, SpO2, NIBP, RR

IBP1

HR, SpO2, IBP1, RR

IBP2

HR, SpO2, IBP2 RR

IBP3

HR, SpO2, IBP3, RR

Temp

HR, SpO2, T1, T2, ' T

Continuous Waveform Recording

Continuous waveform recording allows you to record continuous waveforms to a full

disclosure case log for the patient being monitored. This feature needs to be enabled by a

supervisor. The supervisor can access this feature by pressing the Setup quick access key (

),

and then selecting Supervisor>Log>Waveform Recording. In this menu, the following settings

can be customized:

• Record Displayed Waveforms – Record only the top waveform that is displayed or record

all waveforms that are displayed.

• Record Additional Waveforms – Always record the CO2 waveform or always record the

IBP and the CO2 waveforms.

There is an additional waveform that can be enabled in the Waveform Recording menu. This

option, Record Pads Imp. Waveform, measures the patient’s impedance between

defibrillation electrodes.

Note:

When Continuous waveform recording is disabled, no waveforms (except snapshots)

are recorded.

The full disclosure case can, at a minimum, concurrently store the following information:

• 32 monitor snapshots

• 500 non-ECG events

• 24 hours of continuous ECG (4 waveforms), Capnography, IBP (3 channels), and Pads

Impedance

The actual information that is stored depends on usage. Also, the specific combination of stored

continuous waveform data depends on how the waveform recording settings are configured in

the Supervisor menu.

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CHAPTER 4 TRENDS

4-4

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Chapter 5

Alarms

The X Series unit supports the detection and indication of patient alarms and technical alerts.

A patient alarm is any alarm condition that is caused by a monitored patient-related variable,

such as a measured vital sign that falls outside of a configured alarm limit. You can configure

patient alarm limits for each of the physiologic monitoring functions.

A technical alert is monitored equipment-related variable that the X Series unit can detect, such

as a disconnected sensor, internal diagnostics failures, and so on. Technical alerts are always

enabled and are not user-configurable.

Patient alarms are always classified as high-priority alarms. Technical alerts are classified as

medium or low priority alarms.

Alarm conditions from patient alarms and technical alerts are stored in the Event Log and

retained with normal power down or total loss of power.

Visual Alarm Indicators

In addition to status messages that appear on the display, the X Series unit lights the red or

yellow LED on the front panel to indicate the priority level of the highest-priority active alarm.

The X Series LEDs indicate the priority level of the highest-priority active alarm as shown in

the following table.

Active Alarm Priority

Visual Alarm Indicator

High Priority -- Patient Alarm

Flashing Red LED

Medium Priority -- Technical Alert

Flashing Yellow LED

Low Priority -- Technical Alert

Continuous Yellow LED

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CHAPTER 5 ALARMS

Audible Alarm Indicators

The X Series unit sounds an audible alarm to indicate the priority level of highest-priority

active alarm. The X Series indicates the priority level of the highest-priority active alarm by

sounding the audible alarm tones described in the following table.

Active Alarm Priority

Audible Alarm Indicator

Alarm/Alert Volume

High Priority -Patient Alarm

Two sets of five short beep tones,

repeated at 15-second intervals

Volume is adjustable, up to a

maximum sound pressure of at

least 70 dBA (measured at 1m)

Medium Priority -Technical Alert

One set of three longer beep tones,

repeated at 30-second intervals

Volume is 3 to 12 dBA below high

priority alarm

Low Priority -Technical Alert

A single short beep tone, not

repeated

Volume is 3 to 6 dBA below the

medium priority alert

Audible alarms can be silenced or suspended. More detailed information about how to silence

and suspend audible alarms is included later in this chapter.

Alarm Indicator Self-Test

The X Series unit performs a self-test of the audio and visual alarm indicators upon power-up.

To ensure that the alarms and alerts are functioning properly, verify that two alarm tones are

heard and the green, yellow, and red LEDs are illuminated upon power up.

5-2

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Patient Alarm Display

Patient Alarm Display

When a patient’s vital signs measurements trigger an alarm, in addition to sounding the patient

alarm, the X Series unit displays an alarm message, and changes the display characteristics of

the monitoring function’s numeric display (the alarming parameter appears in red against a

white background).

In the following example, the EtCO2 measurement (22 mmHg) has dropped below the lower

alarm limit (EtCO2 Low Alarm):

06/06/2011

12:34:56

Adult

00:17:43

EtCO2 Low Alarm

I, II,

III...

II

1 cm/mV

12

CO2

R

SYNC

HR

bpm NIBP

80 121

T1

98.6

9650-001355-01 Rev. H

ºF

79

mmHg CO2

mmHg SpO2

38

22

(96)

BR

X Series Operator’s Guide

%

97

12

33

5-3

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CHAPTER 5 ALARMS

Life Threatening Rhythm Alarms

When LTA monitoring is enabled, the X Series will monitor for the following life threatening

ECG rhythms: asystole, ventricular fibrillation, ventricular tachycardia, extreme bradycardia,

and extreme tachycardia.

Depending upon configuration of the unit, it generates visible and audible alarms as needed.

Note:

LTA monitoring is not available in AED mode.

Equipment Alert Display

When a problem with the X Series unit or an attached sensor triggers an alert, in addition to

sounding an equipment alert, the X Series unit displays an alert message (yellow background,

black text).

Warning!

Always respond immediately to a system alarm since the patient may not be monitored

during certain alert conditions.

In the following example, an equipment alert message indicates that the SpO2 sensor has

become unattached (SpO2 Check Sensor) from the unit:

06/06/2011

12:34:56

Adult

00:17:43

SpO2 Check Sensor

I, II,

III...

II

1 cm/mV

12

CO2

R

SYNC

HR

bpm NIBP

mmHg CO2

80 121

T1

98.6

5-4

ºF

38

(96)

79

www.zoll.com

mmHg SpO2

BR

%

Check

Sensor

12

9650-001355-01 Rev. H

Page 81

Responding to Active Alarms -- Silencing the Alarm

Responding to Active Alarms -- Silencing the Alarm

When a patient alarm is triggered and the alarm tone sounds

1. Check the patient and provide appropriate care.

2. Press the Alarm Silence/Reset button (

)on the X Series unit’s front panel to silence the

alarm briefly (90 seconds).

3. After caring for the patient, check that the appropriate alarms are set (for more information

about setting and enabling alarms, see appropriate monitoring chapters later in this manual).

Note:

Pressing

suspends the alarm tone for all active alarms. If the patient’s vital signs

measurements trigger another, different alarm, the patient alarm tone will sound, even

if the first alarm silence period hasn’t expired.

Re-enabling an Alarm

To re-enable an alarm before the alarm silence period has expired, press the Alarm Silence/

Reset button.

Warning!

Do not silence the audible alarm if patient safety may be compromised.

Suspending Alarms

When caring for a patient, you may want to suspend potential or current patient alarms and

equipment alerts for a period of time. To suspend patient alarms

1. Press the More quick access key (

)to access the second set of quick access keys and

press the Alarms quick access key.

2. Press the Alarms Suspend quick access key ( ).

No alarms will sound while alarms are suspended; however, if an alarm occurs during the

suspension period, the X Series unit will display visual alarm indicators -- alarm messages in

the message area (white text on a red background) and red/white numeric displays).

The duration of the alarm suspension can be configured to be for 2, 4, or 15 minutes, or for an

indefinite period of time. The ability to suspend alarms can also be disabled.

Warning!

When audible alarms are disabled, make sure that the patient is closely observed.

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CHAPTER 5 ALARMS

The Alarm Suspension Timer

During an alarm suspension, the window displays an alarm suspension timer at the top of the

display next to the message area:

Alarm Suspension Timer

06/06/2011

12:34:56

Adult

1:30

EtCO2 Low Alarm

I, II,

III...

II

00:17:43

1 cm/mV

12

CO2

R

SYNC

HR

bpm NIBP

mmHg CO2

80 121

T1

98.6

5-6

ºF

38

22

(96)

79

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mmHg SpO2

BR

%

97

12

33

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Page 83

Alarm Options

Alarm Options

The X Series unit provides alarm options that you can specify through the Supervisor parameter

control panel (access to Supervisor is passcode-controlled).

Press the More quick access key ( ), press the Setup quick access key ( ), and select

Supervisor. Using the navigation keys, select the four digits in the Supervisor passcode. Press

SAVE when you are finished. Once you have entered your supervisor passcode, you will be

able to access the configurable options in the Supervisor menu.

Select Alarms to display the alarms parameter control panel:

Setup > Supervisor > Alarms

General

Default Adult

Default Pediatric

Default Neonate

Figure 5-1 Alarms Parameter Control Panel

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CHAPTER 5 ALARMS

Selecting Default Alarm Limits

The first three options -- Default Adult, Default Pediatric, Default Neonate -- allow you to set all

alarm limits to the X Series unit’s factory-specified default values, by patient type.

Warning!

•

A potential hazard exists if different alarm limits are used for the same or similar

equipment in any single area.

•

Confirm the alarm limits are appropriate for the patient each time there is a new

patient case.

•

Do not set alarm limits to such extreme values that render the alarm system useless.

Setting Alarm Limits Relative to the Patient -- Stat Set Option

The X Series unit also allows you to set all alarm limits relative to the patient’s current vital

signs measurements by performing the following actions:

1. Press

.

2. Press the Alarm quick access key (

3. Press the Stat Set quick access key (

).

Stat

Set

). The X Series unit sets all parameters to a new value

based on the current values as follows:

Parameter

(units)

HR/PR

(bpm)

IBP

(mmHg)

NIBP

(mmHg)

RR/BR

(/min)

5-8

Range

Upper Limit Calculation

Lower Limit Calculation

Numeric < 26

Limit is unchanged

Limit = 25

26 dNumeric d 99

Limit = Numeric x 1.2

Limit = Numeric x 0.8

100 d Numeric d 250

Limit = Numeric + 20

Limit = Numeric – 20

Numeric > 250

Limit = 250

Limit is unchanged

Numeric < 26

Limit = Numeric + 5

Limit = Numeric – 5

26 d Numeric d 99

Limit = Numeric x 1.2

Limit = Numeric x 0.8

Numeric > 99

Limit = Numeric + 20

Limit = Numeric – 20

Numeric < 26

Limit = Numeric + 5

Limit = Numeric – 5

26 d Numeric d 99

Limit = Numeric x 1.2

Limit = Numeric x 0.8

Numeric > 99

Limit = Numeric + 20

Limit = Numeric – 20

Numeric < 26

Limit = Numeric + 5

Limit = Numeric – 5

26 d Numeric d 99

Limit = Numeric x 1.2

Limit = Numeric x 0.8

Numeric > 99

Limit = Numeric + 20

Limit = Numeric – 20

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Page 85

Alarm Options

Entire range

Limit = 100 (Adult and

Pediatric)

Limit = Numeric + 5 (Neonate)

Limit = Numeric – 5

SpCO

(%)

Entire range

Limit = Numeric + 2

Upper limit 40

Limit = Numeric - 2

Lower limit 0

SpMet

(%)

Entire range

Limit = Numeric + 2

Upper limit 15

Limit = Numeric - 2

Lower limit 0

EtCO2

Entire range

Limit = Numeric + 10

Limit = Numeric - 5 mmHg

unless the numeric falls

below the lower alarm limit

range, in which case Stat

Set sets the lower limit to

15 mmHg.

Entire range

Limit = Numeric + 5

N/A

Temp

(°C)

Entire range

Limit = Numeric + 0.5

Limit = Numeric – 0.5

Temp

(°F)

Entire range

Limit = Numeric + 0.9

Limit = Numeric – 0.9

SpO2

(%)

(mmHg)

FiCO2

(mmHg)

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CHAPTER 5 ALARMS

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Page 87

Chapter 6

Monitoring ECG

This chapter describes how to use the X Series unit to monitor ECG.

X Series units can perform ECG monitoring through 3-, 5-, or 12-lead ECG patient cables,

Multi-Function Pads, or standard defibrillation paddles. The use of an ECG patient cable and

electrodes is required, however, to monitor ECG during pacing.

OneStep cables and electrodes cannot be used for ECG monitoring.

You can use a 3-lead, 5-lead, or 12-Lead wire configuration for ECG monitoring (see Running

H/F 1 for more information on 12-lead monitoring).

Warning!

•

Excessive body hair or wet, sweaty skin may interfere with electrode adhesion.

Remove the hair and/or moisture from the area where the electrode is to be attached.

•

Use only electrodes that are well within the expiration date indicated on the package.

•

Remove ECG electrodes from their sealed package immediately prior to use. Using

previously opened or out-of- date electrodes may degrade the ECG signal quality.

•

Monitoring electrodes may become polarized during defibrillator discharge, causing

the ECG waveform to briefly go off screen. ZOLL Medical Corporation recommends

the use of high quality silver/silver chloride (Ag/AgCl) electrodes to minimize this

effect; the circuitry in the instrument returns the trace to the monitor display within

a few seconds.

•

To assure protection against the effects of defibrillator discharge, use only

ZOLL-approved accessories.

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CHAPTER 6 MONITORING ECG

•

To avoid a shock hazard and interference from nearby electrical equipment, keep

electrodes and patient cables away from grounded metal and other electrical

equipment.

•

To avoid electrosurgery burns at monitoring sites, ensure proper connection of the

electrosurgery return circuit so that the return paths cannot be made through

monitoring electrodes or probes.

•

Check the operation and integrity of the X Series unit and ECG cable regularly by

performing the Daily Operational Verification Test.

•

Implanted pacemakers may cause the heart rate meter to count the pacemaker rate

during incidents of cardiac arrest or other arrhythmias. Carefully observe

pacemaker patients. Check the patient's pulse; do not rely solely on heart rate

meters. Dedicated pacemaker detection circuitry may not detect all implanted

pacemaker spikes. Patient history and physical exam are important in determining

the presence of an implanted pacemaker.

ECG Monitoring Setup

The proper application and placement of electrodes is essential for high quality ECG

monitoring. Good contact between the electrode and skin minimizes motion artifact and signal

interference.

The following procedure describes how to monitor a patient’s ECG using 3- and 5-Lead ECG

cables. For information on the application and use on MultiFunction Pads and External

Paddles, which you can also use to monitor ECG, see Chapter 15, Manual Defibrillation.

To monitor a patient’s ECG using 3- and 5-Lead ECG cables, perform the following steps:

1. Prepare the patient's skin for electrode application:

2. Apply the electrode pads to the patient.

3. Connect each lead of the ECG cable to the appropriate electrode.

4. Insert the patient cable plug into the ECG input connector on the X Series unit.

5. Select the ECG waveforms to be displayed on the waveform trace display screen.

6. Observe the patient‘s electrocardiogram on the display, and adjust size of the ECG waveform

trace, as necessary.

Preparing the Patient for Electrode Application

The proper application of electrodes is essential for high quality ECG monitoring. Good contact

between the electrode and skin minimizes motion artifact and signal interference.

Before applying electrodes, prepare the patient’s skin, as necessary:

•

•

•

6-2

Shave or clip excess hair at electrode site.

Clean oily skin with an alcohol pad.

Rub site briskly to dry.

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9650-001355-01 Rev. H

Page 89

ECG Monitoring Setup

Applying Electrodes to the Patient

The following sections show where to place electrodes when using 3- and 5-Lead cables to

perform ECG monitoring. For 3-Lead ECG cables, apply electrodes as in Figure 4-1, 3-Lead

Electrode Placement. For 5-Lead ECG cables, apply electrodes as in Figure 4-2, 5-Lead

Electrode Placement.

Avoid placing electrodes over tendons and major muscle masses.

Make sure that the ECG electrodes are placed to allow defibrillation, if necessary.

3-Lead Electrode Placement

Depending upon local usage, the ECG leads are marked either RA, LA, and LL (or R, L, and

F). The following table shows the markings and color codes for the different lead sets.

AHA Color Coding

IEC Color Coding

Placement of Electrodes

RA/White Electrode

R/Red Electrode

Place near patient’s right mid-clavicular line,

directly below clavicle.

LA/Black Electrode

L/Yellow Electrode

Place near patient’s left mid-clavicular line,

directly below clavicle.

LL/Red Electrode

F/Green Electrode

Place between 6th and 7th intercostal

space on patient’s left mid-clavicular line.

Figure 6-1 3-Lead Electrode Placement

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CHAPTER 6 MONITORING ECG

5-Lead Electrode Placement

Depending upon local usage, the ECG leads are marked either RA, LA, LL, RL, and V or R, L,

F, N and C. The following table shows the markings and color codes for the different lead sets.

AHA Color Coding

IEC Color Coding

Placement of Electrodes

RA/White Electrode

R/Red Electrode

Place near patient’s right mid-clavicular line,

directly below clavicle.

LA/Black Electrode

L/Yellow Electrode

Place near patient’s left mid-clavicular line,

directly below clavicle.

LL/Red Electrode

F/Green Electrode

Place between 6th and 7th intercostal

space on patient’s left mid-clavicular line.

RL/Green* Electrode

N/Black* Electrode

Place between 6th and 7th intercostal

space on patient’s right mid-clavicular line.

V/Brown* Electrode

C/White* Electrode

Single movable chest electrode. Place this

electrode in one of the positions, V1 - V6,

as shown in the following figure.

V1 -- 4th intercostal space at right sternal

margin.

V2 -- 4th intercostal space at left sternal

margin.

V3 -- Midway between V2 and V4 leads.

V4 -- 5th intercostal space at mid-clavicular

line.

V5 -- Same transverse level as V4 at left

anterior-axillary line.

V6 -- Same transverse level as V4 at left

mid-axillary line.

6-4

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Page 91

ECG Monitoring Setup

Figure 6-2 5-Lead Electrode Placement

Connecting the ECG Cable To the X Series Unit

The X Series unit accepts Welch Allyn Propaq® ECG cables as well as ZOLL

X Series ECG cables. Connect the ECG cable to the ECG connector on the left side of the X

Series unit as follows:

Figure 6-3 Connecting ECG Cable to X Series Unit

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CHAPTER 6 MONITORING ECG

Selecting ECG Waveforms for Display

You can fit up to four waveforms on the X Series display. The first waveform at the top of the

display is always an ECG waveform. (If Pads are not connected, the unit can be configured to

automatically default to another ECG lead.) In the following example, Lead II (RA-LL), is the

source of the ECG waveform trace:

06/06/2011

I, II,

III...

12

CO2

R

SYNC

The X Series unit is configured to display Pads by default for the top trace. If configured, the

unit can also display four ECG traces on startup, when no other monitoring devices are

attached.

The are two ways to specify which ECG lead is the source of the primary waveform trace. One

I, II,

way is to press the ECG lead selection quick access key III... to display the available ECG

waveform sources. The available waveform sources are determined by the type of ECG cable

connected to the unit.

The other way to specify the source of the primary waveform trace is to navigate to and select

the source label for the primary ECG waveform (Lead l in the screen below). The X Series unit

then displays the available ECG waveform sources. The following example illustrates the

waveform source list that the X Series unit displays when a 5-lead ECG cable is connected to it.

The list of available ECG waveform sources includes Leads I, II, III, aVR, aVL, aVF, and V. You

can select Lead lI (the default), or use the navigation keys to highlight and select another

displayed ECG lead as the source for the waveform trace.

6-6

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ECG Monitoring Setup

06/06/2011

I, II,

III...

I

12

CO2

R

12:34:56

Adult

00:17:43

Source

1 cm/mV

Pads

I

II

III

aVR

aVL

aVF

V

Insert

Cascade

SYNC

HR

bpm NIBP

80 121

T1

98.6

ºF

mmHg CO2

38

(96)

79

mmHg SpO2

BR

%

97

12

Select a current waveform source, and the unit displays the waveform immediately. If you

select a waveform source that is not currently available, the unit displays the message, LEAD

FAULT.

For more information on how to configure the display of waveforms on the X Series unit, see

Chapter 3, Monitoring Overview.

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CHAPTER 6 MONITORING ECG

Selecting the Waveform Trace Size

The X Series unit allows you to select the waveform trace size to adjust the size of displayed

the ECG waveform.

To select the waveform size, use the navigation keys to highlight and select the trace size that

appears to the right of the electrode label:

06/06/2011

I, II,

III...

II

12:34:56

Adult

00:17:43

Lead II Size

1 cm/mV

0.125 cm/mV

0.25 cm/mV

0.50 cm/mV

1.0 cm/mV

2.0 cm/mV

4.0 cm/mV

Auto

12

CO2

R

SYNC

HR

bpm NIBP

80 121

T1

98.6

ºF

mmHg CO2

38

(96)

79

mmHg SpO2

BR

%

97

12

The default trace size is 1cm/mV. You can select a larger (2.0, 4.0 cm/mV) or smaller

(0.125, 0.25, 0.50 cm/mV) trace size. You can also specify that the X Series unit select a best-fit

trace size (AUTO).

6-8

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Page 95

ECG Monitoring and Pacemakers

ECG Monitoring and Pacemakers

When the unit performs ECG monitoring on a patient with an implantable pacemaker, the unit’s

Pacer indicator feature can indicate the occurrence of pacemaker signals.

If the Pacer Indicator setting is ON, the X Series performs the following actions:

• detects the implantable pacemaker pulses

• blanks the pacemaker pulses from the waveform—preventing them from disturbing the

ECG waveform and allowing for an accurate QRS detection

• displays and prints vertical dashed lines to indicate the detected pacemaker signals

If the Pacer Indicator setting is OFF, the X Series does not perform the following actions:

• detect the implantable pacemaker pulses

• blank the pacemaker pulses from the waveform

• display or print the vertical dashed line pacer markers

You can turn the Pacer Indicator ON/OFF from the Setup>ECG menu.

There are situations where ECG artifact could simulate pacemaker signals which could cause

false pacemaker detection and blanking. These situations may cause inaccurate QRS detection

and it may be desirable to turn the Pacer Indicator off. Inversely, when the Pacer Indicator

setting is OFF, implantable pacemaker signals may cause inaccurate QRS detection and it may

be desirable to turn the Pacer Indicator on.

ECG System Messages

When monitoring ECG, the X Series unit may display the following messages:

System Message

Cause

LEAD FAULT

The current ECG source lead is defective (check

lead and replace, if necessary).

-- OR -An unavailable waveform source has been specified

for the trace display (check specified waveform

source and correct, if necessary).

PADDLE FAULT or CABLE FAULT Check the pad, paddle or cable and replace if

necessary.

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CHAPTER 6 MONITORING ECG

6-10

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Page 97

Chapter 7

Monitoring Respiration (Resp) and Heart Rate (HR)

This chapter describes how to use the X Series unit to monitor Respiration (Resp) and Heart

Rate (HR).

The X Series unit displays Respiration (Resp) and Heart Rate (HR) meters. The Respiration and

Heart Rate meters display values that the X Series unit derives from measurements taken by

other X Series monitoring functions.

06/06/2011

I, II,

III...

II

12:34:56

Adult

00:17:43

1 cm/mV

12

CO2

R

SYNC

HR

bpm NIBP

80 121

T1

Heart Rate

Meter

98.6

9650-001355-01 Rev. H

ºF

mmHg Resp

(96)

br/min SpO2

16

%

97

79

Respiration Meter

X Series Operator’s Guide

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Page 98

Chapter 7 Monitoring Respiration (Resp) and Heart Rate (HR)

Note:

The respiration rate is disabled during defibrillation. During defibrillation, the

respiration rate will display ??? on the snapshot.

Respiration/Breath Rate Meter

If enabled, the X Series unit displays the patient’s respiration in the Respiration/Breath Rate

Meter.

The respiration meter displays the respiration rate that it derives, by default, from the unit’s

CO2 monitoring function. If CO2 monitoring is not available, the unit derives the respiration

rate through impedance pneumography, using a specified ECG electrode configuration. If ECG

monitoring isn’t functioning, the Resp/BR meter will not display a respiration rate.

Using Impedance Pneumography to Measure Respiration

Impedance pneumography detects respiration by applying a high-frequency, low-current AC

signal to the patient and measuring the changes in impedance through ECG electrode Lead l

(RA-LA) or Lead ll (RA-LL). As the patient inhales and chest volume expands, impedance

increases; as the patient exhales, impedance decreases.

Warning!

7-2

•

Impedance pneumography detects respiratory effort through changes in chest

volume. However, No Breath episodes with continued respiratory effort may go

undetected. Always monitor and set alarms for SpO2 when using impedance

pneumography to monitor respiratory function.

•

With any monitor that detects respiratory effort through impedance pneumography,

artifact due to patient motion, apnea mattress shaking, or electrocautery use may

cause apnea episodes to go undetected. Always monitor and set alarms for SpO2

when using impedance pneumography to monitor respiratory function.

•

When using impedance pneumography, don’t use the X Series unit with another

respiration monitor on the same patient, because the respiration measurement

signals may interfere with one another.

•

Impedance pneumography is not recommended for use on paced patients, because

pacemaker pulses may be falsely counted as breaths.

•

Impedance pneumography is not recommended for use with high frequency

ventilation.

•

Since impedance pneumography uses the same leads as the ECG channel, the

X Series unit determines which signals are cardiovascular artifact and which signals

are the result of respiratory effort. If the breath rate is within five percent of the

heart rate, the monitor may ignore breaths and trigger a respiration alarm.

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Configuring Respiration (RR/BR) Alarms and Settings

Configuring Respiration (RR/BR) Alarms and Settings

The X Series unit allows you to enable and disable the Respiration (RR/BR) Rate alarm, to set

alarm limits, and to specify the ECG monitoring source for the Respiration rate.

Enabling/Disabling RR/BR Alarms and Setting Alarm Limits

When enabled, the X Series unit sounds alarms whenever the patient’s respiration rate is above

or below the specified respiration rate alarm limits.

To enable (or disable) Resp alarms and set Upper and Lower alarm limits, you can either do so

through the Alarms quick access key (

), or the Resp Parameter Control Panel.

To configure RR/BR alarms through the Alarms quick access key:

1. Press

2. Press

.

.

3. Press the Limits quick access key ( Limits). Use the navigation keys to highlight and select the

RR/BR Alarm menu selection.

4. On the RR/BR Alarm Settings menu, use the navigation keys to select the fields that you want

to change:

•

•

•

•

Upper Limit Enable

Lower Limit Enable

Upper Limit

Lower Limit

5. When you are finished changing values on the alarm menu, navigate to the Backarrow key

to confirm your choices and exit the menu.

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Chapter 7 Monitoring Respiration (Resp) and Heart Rate (HR)

Respiration Rate Alarm Limits

Initially, the Resp Alarm Settings menu specifies that Resp alarms are enabled (ON) or

disabled (OFF), and displays the default Upper and Lower respiration rate alarm limits. The

upper and lower limits can be ON or OFF (default is OFF).The following table lists the default

respiration rate alarm limits for adult, pediatric, and neonate patients, and gives the range in

which you can set these limits:

Patient Type

Respiration Rate Default

Respiration Rate Range

Adult

Lower: 3 br/min

Lower: 0 to 145 br/min

Upper: 50 br/min

Upper: 5 to 150 br/min

Lower: 3 br/min

Lower: 0 to 145 br/min

Upper: 50 br/min

Upper: 5 to 150 br/min

Lower: 12 br/min

Lower: 0 to 145 br/min

Upper: 80 br/min

Upper: 5 to 150 br/min

Pediatric

Neonate

Using the Resp Parameter Control Panel

To configure alarms through the Resp Parameter Control Panel, use the navigation keys to

highlight and select the Respiration Rate meter and display the Resp Parameter Control Panel:

Resp

RR/BR Alarm

Lower

Upper

10

30

No Breath Alarm

30 sec

Resp Monitoring

On

Resp Lead

Lead II (RA-LL)

CO2/Resp Sweep Speed

12.5 mm/s

Figure 7-1 Respiration Parameter Control Panel

The Resp Parameter Control Panel allows you to set the following parameters:

• RR/BR Alarm -- enable/disable the Resp alarm and set high/low alarm limits.

• No Breath Alarm -- sets the duration of the No Breath alarm, or disables alarm by selecting

“Off”.

• Resp Monitoring -- enable/disable respiration monitoring.

• Resp Lead -- selects the Resp lead, Lead I (RA-LA) or Lead II (RA-LL), from which the X

Series unit calculates the respiration rate. Resp Lead selection is independent of ECG Lead

selection.

• CO2/Resp Sweep Speed -- sets the respiratory sweep speed on the display.

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Heart Rate Meter

Enabling/Disabling Resp Monitoring

Select the Resp Monitoring prompt to enable or disable Resp monitoring. When Resp

Monitoring is set to On (the default), the X Series unit displays the Respiration Rate Meter.

When set to off, X Series removes the Respiration Rate meter from the display.

Warning!

When using impedance pneumography, the X Series unit automatically rejects

cardiovascular artifact (CVA). This function requires the accurate ECG R-wave

detection. Therefore, always select the ECG lead with the most prominent QRS complex

when using impedance pneumography to monitor respiration.

Heart Rate Meter

The Heart Rate meter displays the heart rate that it derives from the ECG monitoring function

(by default) or from a monitoring function that you specify. If the ECG (or user-specified

monitor function) measurements are not available, the Heart Rate meter derives the heart rate

from the following monitoring functions, if they are available, in this order: User-selected

default source, ECG, IBP channel 1, SpO2, IBP channel 2, IBP channel 3, and NIBP. The Heart

Rate meter is labeled HR (as in the following example) if the source is ECG, and PR if any

other source is used.

Note:

The Heart Rate meter displays heart rates below 20 as three dashes (---) and heart rates

above 300 as three plus signs (+++).

Configuring Heart Rate (HR) Meter Alarms

The X Series unit allows you to enable and disable the Heart Rate (HR) alarm, to set alarm

limits, and to select a Heart Rate tone.

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Chapter 7 Monitoring Respiration (Resp) and Heart Rate (HR)

Enabling/Disabling HR Alarms and Setting Alarm Limits

When enabled, the X Series unit sounds alarms whenever the patient’s heart rate is above or

below the specified heart rate alarm limits.

To enable (or disable) HR alarms and set Upper and Lower alarm limits, you can either do so

through the Alarms quick access key (

) or the HR/PR Parameter Control Panel.

To configure HR alarms through the Alarms quick access key:

1. Press

.

2. Press

.

3. Press

.

4. Use the navigation buttons to highlight and select HR/PR Alarm.

5. On the HR/PR Alarm Settings menu, use the navigation keys to select the fields that you want

to change:

Limits

•

•

•

•

Upper Limit Enable

Lower Limit Enable

Upper Limit

Lower Limit

When you are finished changing values on the alarm menu, navigate to the Backarrow key to

confirm your choices and exit the menu.

Heart Rate (HR/PR) Alarm Limits

Initially, the HR/PR Alarm Settings menu specifies that alarms are enabled (ON) or disabled

(OFF), and displays the default Upper and Lower heart rate alarm limits. The upper and lower

limits can be ON or OFF (default is OFF). The following table lists the default HR alarm limits

for adult, pediatric, and neonate patients, and gives the range in which you can set these limits:

Patient Type

HR Default

HR Range

Adult

Lower: 50 BPM

Lower: 30 to 298 BPM

Upper: 120 BPM

Upper: 32 to 300 BPM

Lower: 50 BPM

Lower: 30 to 298 BPM

Upper: 150 BPM

Upper: 32 to 300 BPM

Lower: 100 BPM

Lower: 30 to 298 BPM

Upper: 200 BPM

Upper: 32 to 300 BPM

Pediatric

Neonate

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Configuring Heart Rate (HR) Meter Alarms

Life Threatening Rhythm Alarms

When LTA monitoring is enabled, the X Series unit will monitor for the following life

threatening ECG rhythms: asystole, ventricular fibrillation, ventricular tachycardia, extreme

bradycardia, and extreme tachycardia. These events are also displayed on Treatment Summary

Reports, Alarm Snapshots, and Continuous Waveform printouts.

The following example shows an Asystole alarm event:

To enable or disable LTA alarms and set Extreme Brady/Tachy alarm limits, you can either do

so through the Alarms quick access key (

), or the HR/PR Parameter Control Panel.

To configure LTA alarms through the Alarms quick access key:

1. Press

2. Press

3. Press

•

•

.

.

Limits

. Use the navigation keys to highlight and select the fields that you want to change:

LTA Monitoring

Extreme Brady/Tachy Alarms

When you are finished changing values on the alarm menu, navigate to the Backarrow key to

confirm your choices and exit the menu.

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Chapter 7 Monitoring Respiration (Resp) and Heart Rate (HR)

Extreme Bradycardia and Extreme Tachycardia Alarm Limits

The Extreme Brady/Tachy Alarm Settings menu specifies the configured delta values that are

applied to the HR lower limit alarm and HR upper limit alarm for the Extreme Bradycardia and

Extreme Tachycardia LTA alarm detection, respectively. For example, if the HR lower limit

alarm is configured to 50 and the Extreme Brady delta value is configured to -10, the Extreme

Bradycardia LTA detection threshold will be at 40 bpm. Likewise, if the HR upper limit alarm

is configured to 120 and the Extreme Tachy delta value is configured to +20, the Extreme

Tachycardia LTA detection threshold will be at 140 bpm. The HR lower and upper limit alarms

are not required to be enabled for the Extreme Bradycardia and Extreme Tachycardia LTA

alarm detection to be enabled. The Extreme Bradycardia and Extreme Tachycardia LTA alarms

will not activate until 20 seconds after the alarm limit threshold is crossed.

The following tables list the default Extreme Bradycardia and Extreme Tachycardia alarm

limits for adult, pediatric, and neonate patients, and the ranges in which you can set these

limits:

Extreme Bradycardia Alarm Limits

Patient Type

Default

Delta Value Range

Adult

-10

-5 to -30 in increments of 5

Pediatric

-10

-5 to -30 in increments of 5

Neonate

-10

-5 to -30 in increments of 5

Extreme Tachycardia Alarm Limits

Patient Type

Default

Delta Value Range

Adult

+20

+5 to +30 in increments of 5

Pediatric

+20

+5 to +30 in increments of 5

Neonate

+20

+5 to +30 in increments of 5

Acknowledging LTA Alarms

LTA alarms are latching, which means that the alarm indication will persist until both of the

following conditions are met:

1. The alarm has been acknowledged by pressing the Alarm Silence/Reset button on the front

panel of the unit.

2. The alarming condition no longer exists.

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Configuring Heart Rate (HR) Meter Alarms

Using the Heart Rate Parameter Control Panel

To configure alarms through the Heart Rate Parameter Control Panel, use the navigation keys to

highlight and select the Heart Rate meter and display the HR/PR Parameter Control Panel:

Figure 7-2 HR/PR Parameter Control Panel

Selecting the HR/PR Alarm prompt displays the HR/PR Alarm Settings menu, on which you

can enable/disable Heart Rate alarms and set alarm limits.

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Chapter 7 Monitoring Respiration (Resp) and Heart Rate (HR)

RESP System Message

When monitoring Respiration using impedance pneumography, the X Series unit may display

the following message:

7-10

System Message

Cause

RESPIRATION FAULT

The impedance measured through the ECG lead is

too high for the unit to detect Respiration changes,

but not high enough to indicate an ECG lead fault

(the impedance may vary between 1800 and 2800

ohms).

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Chapter 8

Monitoring Non-Invasive Blood Pressure (NIBP)

The X Series NIBP input is Type CF defibrillator proof.

This chapter describes how to use the X Series unit to perform Non-Invasive Blood Pressure

(NIBP) measurements using an inflatable cuff to measure arterial pressure.

The X Series uses the enhanced NIBP features of Welch Allyn’s SureBP and patented Smartcuf

motion-tolerant technology.

The X Series unit must perform ECG monitoring when using Smartcuf.

The SureBP monitoring software allows the X Series unit to take an NIBP measurement as the

cuff is inflating, which saves time -- the measurement takes about 15 seconds -- and improves

patient comfort.

The Smartcuf monitoring software enables the X Series unit to make accurate NIBP

measurements in the presence of extreme artifact, weak pulses, and some dysrhythmias by

synchronizing the NIBP measurements with the patient’s R-wave.

Warning!

•

Observe the patient’s limb periodically to ensure that circulation is not impaired for

a prolonged period of time.

•

Never use the X Series to monitor NIBP on one patient while simultaneously

monitoring ECG on another patient.

•

If a non-invasive blood pressure measurement is suspect, repeat the measurement. If

you are still uncertain about the measurement, use another method.

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CHAPTER 8 MONITORING NON-INVASIVE BLOOD PRESSURE (NIBP)

•

Do not use NIBP without proper training. Check that the correct patient mode has

been selected to ensure that the initial inflation pressure is set correctly. Patient

movement, very low pulse volume, or vibration from outside sources can influence

the accuracy of blood pressure measurements.

•

Do not attempt to take NIBP measurements on patients during cardiopulmonary

bypass procedures.

•

Some or all NIBP safety functions are disabled when performing the NIBP test in the

Service menu. Do not conduct NIBP tests when the cuff is attached to a patient.

How does NIBP Work?

The blood pressure cuff and hose connect to the X Series unit through the NIBP connector on

the side panel of the unit. The NIBP button on the front panel of the unit allows you to initiate

and terminate blood pressure measurements, which are displayed in the NIBP area of the

monitor.

The X Series unit’s NIBP module measures the oscillometric pulses transmitted through the

blood pressure cuff and hose, and calculates the blood pressure measurements accordingly. The

pressure measurement proceeds as follows:

1. The cuff inflates to a preconfigured pressure (determined by patient type) above the

patient’s systolic blood pressure. As the cuff inflates, the X Series unit measures the

oscillometric pulses transmitted from the cuff through the hose, and the SureBP monitoring

software calculates the patient’s systolic, diastolic, and mean blood pressure. Once these

measurements are taken, the cuff deflates. The X Series unit takes these measurements in

about 15 seconds.

The SureBP feature requires the use of a cuff and dual lumen hose.

2. If high artifact prevents an accurate measurement during cuff inflation, or if you use a cuff

and single lumen hose, the cuff inflates to its target pressure to occlude blood flow through

the arteries in the monitored limb. The cuff deflates incrementally, allowing blood to flow

through the cuff and into the monitored limb. As blood flows through the partially deflated

cuff, it produces pressure oscillations that are transmitted to the X Series unit through the

hose.The X Series unit measures the oscillometric pulses and uses them to calculate the

corresponding systolic, diastolic, and mean blood pressure. This measurement takes about 30

seconds.

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The NIBP Numeric Display

3. The NIBP option automatically adjusts the blood pressure measurement procedure in

response to certain error conditions such as:

Condition

Adjustment/Response

The unit cannot detect systolic

pressure

The unit automatically increases the cuff inflation

pressure and completes the blood pressure measurement

The unit cannot detect systolic,

diastolic or mean pressure after

180 seconds

The unit aborts the blood pressure measurement and

deflates the cuff

The unit detects a fault

The unit displays a corresponding error message on

the monitor and aborts the measurement

The NIBP Numeric Display

When NIBP monitoring has been set up and the X Series unit has begun taking NIBP

measurements, the systolic, diastolic, and mean blood pressure measurements appear on the

NIBP numeric display as follows:

NIBP

mmHg

138 (112)

89

The following sections describe how to set up NIBP monitoring.

NIBP Setup and Use

To take safe and accurate NIBP measurements using the X Series unit, you must perform the

following steps, each of which corresponds to a section in this chapter. Read each section

carefully before you perform NIBP measurements.

1. Select the correct size cuff.

2. Apply the cuff to the patient.

3. Connect the inflation hose to the X Series unit and to the cuff.

4. Configure NIBP alarms and settings (if the current NIBP alarms and settings are not

appropriate).

5. Press the NIBP button on the X Series unit’s front panel and take the blood pressure

measurement.

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CHAPTER 8 MONITORING NON-INVASIVE BLOOD PRESSURE (NIBP)

Selecting the NIBP Cuff

To take accurate measurements, you must use the proper sized cuff: the cuff’s bladder length

should be at least 80 percent of the limb circumference, while the cuff width should be equal to

40 percent of the limb circumference.

Caution

Use only hoses and cuffs that are approved by ZOLL Medical Corporation. See Appendix B,

Accessories, for a listing of the approved hoses and cuffs. Use the following guidelines when

selecting the appropriate hose and cuff:

Adult Mode

Pediatric Mode

Neonate Mode

Adult, Large Adult,

Small Adult, Child,

Thigh

Child, Small Child,

Small Adult, Infant,

Newborn

Neonate #1 to #5

-- disposable

Recommended Limb

Circumference

15 cm or greater.

7.7 to 25 cm

15 cm or less

Hoses

Adult

Adult

Neonate/Infant

(Disposable Cuff only)

Cuffs (typical cuff

labeling)

Newborn (#6), Infant

(#7) -- reusable

* Reusable Newborn

(#6) and Infant (#7)

cuffs use the Adult

Hose.

Caution

Selection of the correct cuff is critical to the accuracy of NIBP measurements. Using a cuff that

is too small results in measurements higher than the patient’s actual blood pressure. Using a cuff

that is too large results in measurements lower than the patient’s actual blood pressure.

The X Series unit uses the same definitions of Neonates, Pediatrics, and Adults as defined in

the AAMI SP10:2002 standard:

8-4

Neonate or Newborn

Children 28 days or less of age if born at term (37 weeks

gestation or more); otherwise, up to 44 gestational weeks

Pediatric or Child

(other than newborn)

Individuals between 29 days and 12 years of age

Adult

Individuals greater than 12 years of age

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Connecting the NIBP Cuff

Connecting the NIBP Cuff

Connecting the NIBP cuff requires you to attach the inflation hose to the X Series unit and the

NIBP cuff. To use the SureBP feature, which enables the X Series unit to measure blood

pressure on cuff inflation, you must use the FlexiPort cuff and dual lumen (two-tube) adaptor

and hose. You can also use a single lumen (one-tube) hose and adaptor with the X Series unit,

but the unit will only measure blood pressure on cuff deflation.

To connect the NIBP cuff to the X Series unit:

1. Attach the inflation hose’s threaded metal connector to the NIBP connector on the side

panel of the X Series unit. Mesh the threads carefully so that the connector turns easily and

then turn the connector in a clockwise direction until it is snug. Attach a double lumen hose

as follows:

Figure 8-1 Attaching a Dual Lumen Hose to the X Series Unit

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CHAPTER 8 MONITORING NON-INVASIVE BLOOD PRESSURE (NIBP)

Attach a single lumen hose as follows:

Figure 8-2 Attaching Single Lumen Hose to the X Series Unit

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Applying the Cuff to the Patient

2. Insert the plastic connectors on the NIBP hose into the cuff hose connector, and twist the

connectors until they lock. The connectors are the same; you can insert either of the plastic

connectors into either of the cuff hose connectors in any order.

Applying the Cuff to the Patient

To apply the cuff to the patient:

1. Ensure the patient is sitting or lying down with the limb relaxed, extended, and placed on a

smooth surface for support.

2. Squeeze as much air from the cuff as possible before placing it on the patient.

3. Place the cuff 2 to 5 cm above the elbow crease or 5 to 10 cm (1.9 to 3.9 in.) above the knee

crease.

Warning!

Do not place the NIBP cuff on the same arm or leg as an SpO2 sensor. Inflation of the

cuff causes the SpO2 monitor to read incorrectly. Also, do not attach the cuff to a limb

being used for IV infusion. Cuff inflation might block the infusion, causing harm to the

patient.

4. Adjust the cuff so that the artery marker on the cuff is over the artery, pointing to the hand or

5.

6.

7.

8.

foot.

Check that the cuff ends between the range lines marked on the cuff.

If they do not line up, use a different size cuff.

Wrap the deflated cuff snugly around the limb without impeding blood flow.

Ensure that the hose is routed to avoid kinking or compression.

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CHAPTER 8 MONITORING NON-INVASIVE BLOOD PRESSURE (NIBP)

Caution

•

Using a cuff that is loosely applied or too small results in measurements higher than the

patient’s actual blood pressure.

•

Using a cuff that is too large results in values lower than the patient’s actual blood pressure.

•

Ideally, the cuff should be at the same level as the heart. Cuff placement substantially above

or below heart level will result in blood pressure measurements that are erroneously low or

high.

The following illustrates one possible cuff placement for adult/pediatric patients and, to the

right, possible cuff placements for neonates:

Figure 8-3 Applying Cuff to the Patient

Ensuring Correct Cuff Inflation Settings

Before taking an NIBP measurement for a new patient, ensure that the cuff inflation settings are

appropriate for that patient.

Check that the correct patient mode is selected. The initial Cuff Inflation Target (CIT) pressure

is dependent on the patient type and the configured CIT preset. The default and configurable

CIT presets for each patient type are indicated in the following table (default values are in

bold).

Note:

You can configure the CIT pressure from the Setup>NIBP menu.

Adult

8-8

Pediatric

Neonate

120 mmHg

80 mmHg

60 mmHg

140 mmHg

90 mmHg

70 mmHg

160 mmHg

100 mmHg

80 mmHg

180 mmHg

110 mmHg

90 mmHg

200 mmHg

120 mmHg

100 mmHg

220 mmHg

130 mmHg

110 mmHg

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Configuring NIBP Alarms and Settings

Adult

Pediatric

Neonate

240 mmHg

140 mmHg

120 mmHg

260 mmHg

150 mmHg

130 mmHg

In order to accurately measure systolic pressure, the CIT pressure must be high enough to

occlude the underlying artery. However, setting the CIT pressure too high may unnecessarily

increase the reading determination time and patient discomfort.

After each NIBP measurement, the X Series unit adjusts the cuff inflation pressure to optimize

the next NIBP measurement.

Note:

Warning!

The maximum cuff inflation pressure for neonates is 153 mmHg.

Before using the X Series unit to monitor a new patient, power down the unit for at least

2 minutes to reset all patient parameters and eliminate all adjustments made for the

previous patient.

Configuring NIBP Alarms and Settings

The last step in preparing to perform NIBP measurements is to ensure that the necessary alarms

are enabled (or disabled), that alarm limits are appropriate, and that the NIBP settings are

correct.

Enabling/Disabling NIBP Alarms and Setting Alarm Limits

When enabled, the X Series unit sounds alarms whenever measurements are outside set limits

for the following:

• High and Low Systolic Pressure

• High and Low Diastolic Pressure

• High and Low Mean Arterial Pressure (MAP)

To enable (or disable) NIBP alarms and set upper and lower alarm limits, you can do so through

the Alarms quick access key (

) or the NIBP Parameter Control Panel.

To configure NIBP alarm limits through the Alarms quick access key:

1. Press the More quick access key ( ).

2. Press the Alarms quick access key ( ).

3. Press the Limits quick access key ( Limits).

4. Use the navigation keys to highlight and select the appropriate alarm menu selection. For

NIBP, the alarm menu selections are NIBP Systolic Alarm, NIBP Diastolic Alarm, and

NIBP MAP Alarm.

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5. On the selected NIBP alarm settings menu, use the navigation keys to select the fields that

you want to change. The fields are

•

•

•

•

Upper Limit Enable

Lower Limit Enable

Upper Limit

Lower Limit

6. When you are finished changing values on the alarm settings menu, select the back arrow to

exit the menu.

Setting Upper and Lower Systolic Alarm Limits

Initially, the NIBP Systolic Alarm Settings menu specifies that the NIBP systolic pressure

alarms are enabled (ON) or disabled (OFF), and displays the default upper and lower systolic

limits. The upper and lower limits can be ON or OFF (default is OFF). The following table lists

the default NIBP Systolic limits for adult, pediatric, and neonate patients, and gives the range in

which you can set these limits:

Patient Type

NIBP Systolic Limit Default

NIBP Systolic Limit Range

Adult

Lower: 75 mmHg

Lower: 30-258 mmHg

Upper: 220 mmHg

Upper: 32-260 mmHg

Lower: 75 mmHg

Lower: 30-158 mmHg

Upper: 145 mmHg

Upper: 32-160 mmHg

Lower: 50 mmHg

Lower: 20-118 mmHg

Upper: 100 mmHg

Upper: 22-120 mmHg

Pediatric

Neonate

Setting Upper and Lower Diastolic Alarm Limits

Initially, the NIBP Diastolic Alarm Settings menu specifies that the NIBP diastolic pressure

alarms are enabled (ON) or disabled (OFF), and displays the default Upper and Lower diastolic

limits. The upper and lower limits can be ON or OFF (default is OFF). The following table lists

the default diastolic limits for adult, pediatric, and neonate patients, and gives the range in

which you can set these limits:

Patient Type

Diastolic Limit Default

Diastolic Limit Range

Adult

Lower: 35 mmHg

Lower: 20-218 mmHg

Upper: 110 mmHg

Upper: 22-220 mmHg

Lower: 35 mmHg

Lower: 20-128 mmHg

Upper: 100 mmHg

Upper: 22-130 mmHg

Lower: 30 mmHg

Lower: 10-108 mmHg

Upper: 70 mmHg

Upper: 12-110 mmHg

Pediatric

Neonate

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Configuring NIBP Alarms and Settings

Setting Upper and Lower NIBP MAP Alarm Limits

Initially, the NIBP MAP Alarm Settings menu specifies that NIBP MAP alarms are enabled

(ON) or disabled (OFF), and displays the default Upper and Lower MAP limits. The upper and

lower limits can be ON or OFF (default is OFF). The following table lists the default MAP alarm

limits for adult, pediatric, and neonate patients, and gives the range in which you can set these

limits:

Patient Type

MAP Default

MAP Range

Adult

Lower: 50 mmHg

Lower: 25-230 mmHg

Upper: 120 mmHG

Upper: 23-228 mmHg

Lower: 50 mmHg

Lower: 25-140 mmHg

Upper: 110 mmHg

Upper: 23-138 mmHg

Lower: 35 mmHg

Lower: 15-110 mmHg

Upper: 80 mmHg

Upper: 13-108 mmHg

Pediatric

Neonate

Using the NIBP Parameter Control Panel

Use the navigation keys to highlight and select the NIBP numeric display to display the NIBP

Parameter Control Panel:

NIBP

Lower

Upper

NIBP Systolic Alarm

75

220

NIBP Diastolic Alarm

35

110

NIBP MAP Alarm

50

NIBP Mode

120

Manual

NIBP Auto Mode Interval

5 min

On

SmartCuf On/Off

Start TurboCuf

59

50

100

150

200

250

300

Figure 8-4 NIBP Parameter Control Menu

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On the NIBP Parameter Control Panel, you can select an alarm configuration option (SYS, DIA,

or MAP) to enable/disable alarms and set high and low alarm limits (as described previously).

You can also configure these NIBP options:

•

•

•

•

NIBP Mode (Mode)

NIBP Automatic Measurement Interval (Auto Interval)

Enable/Disable Smartcuf motion artifact filter (Smartcuf)

Start/Stop Turbocuf Measurements (Turbocuf)

Specify NIBP Mode

You can specify that the X Series unit operate in either Manual or Automatic Mode.

In Manual Mode, the X Series unit takes a single NIBP measurement when you press the NIBP

button on the front panel(

again (select Manual).

). To repeat the NIBP measurement, you must press the NIBP key

In Automatic Mode, the X Series unit takes the first of a series of NIBP measurements when

the Auto Interval timer expires, and then repeats the NIBP measurement at this specified

interval.

Note:

You can press the NIBP button and manually initiate an NIBP reading at any time

while in Automatic Mode. Manually initiated NIBP readings will not affect the timing

of subsequent NIBP readings in Automatic Mode.

Specify the Automatic NIBP Measurement Interval

You can specify the time interval between NIBP measurements in Automatic Mode. The

default interval between measurements is 5 minutes.

You can specify intervals of 1, 2, 3, 5, 10, 15, 30, and 60 minutes between NIBP measurements.

Enable/Disable Smartcuf Motion Artifact Filter

Enabling the use of the Smartcuf motion artifact filter increases the accuracy of NIBP

measurements when motion artifact or weak pulses are present.

NIBP measurements can be adversely affected by many factors, such as cardiac arrthythmias,

sudden changes in blood pressure, body motions such as shivering and convulsions, bumping

the cuff, vibration, vehicle motion, or weak pulses. The Smartcuf filter synchronizes the NIBP

reading with the R-wave of the patient’s ECG to eliminate noise created by patient motion or

vibration.

Note:

The X Series unit must perform ECG monitoring when using Smartcuf.

If artifact is severe, a special symbol appears on the display and printouts:

Figure 8-5 High Artifact Symbol

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Configuring NIBP Alarms and Settings

By default, Smartcuf is Enabled.

There are situations where you may choose to disable Smartcuf. These may include

• Very extreme motion artifact

• Certain types of arrhythmias

• Situations that prevent getting a ECG signal.

NIBP measurements can still be performed with Smartcuf disabled.

Start/Stop TurboCuf

Selecting Start TurboCuf starts Short-term Automatic (STAT) NIBP measurements. The X

Series unit begins its first NIBP measurement, after which it continues to perform as many

NIBP measurements as possible over a 5-minute period.

Select Stop TurboCuf to immediately stop STAT measurements.

WARNING!

Repeated use of STAT measurements on the same patient over a short time interval can

affect blood pressure readings, limit circulation to the limb, and cause injury to the

patient.

Setting the NIBP Display Format

You can specify the appearance of the NIBP numeric display format. The display format allows

you to choose whether or not you will display MAP measurement (M) with the

Systolic (S) and Diastolic (D) measurements in one of the following formats:

• S/D

• S/D (M) (default display)

• (M) S/D

Note:

If a MAP alarm is active when the S/D format is selected, the display format will be

S/D (M) until you clear the MAP alarm.

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CHAPTER 8 MONITORING NON-INVASIVE BLOOD PRESSURE (NIBP)

NIBP System Messages

When monitoring NIBP, the X Series unit may display the following messages:

System Message

Cause

READING IN PROGRESS

The unit is taking an NIBP measurement and

functioning normally.

READING STOPPED

The unit has stopped an NIBP measurement,

because the operator has pressed the NIBP button

and cancelled the measurement.

READING FAILED

The patient’s pulse is too weak to obtain an NIBP

measurement, or the cuff requires adjustment.

ARTIFACT

Excessive artifact is preventing the NIBP

measurement. If ECG is available, consider turning

SmartCuf on.

NEONATE ALERT

The unit has detected a neonate cuff when in Adult

mode. Replace cuff or correct patient mode, as

appropriate. If the detection is in error, dismiss the

alert and reattempt the NIBP measurement.

AIR LEAK

A major air leak is preventing cuff inflation. Check

hose and cuff connections, replace a defective hose

or cuff, as necessary, and reattempt NIBP

measurement.

KINKED HOSE

An air obstruction is preventing the correct operation

of the unit. Check hose for kinks. If using a dual

lumen hose, verify the correct placement of the O

ring on the hose connector. Eliminate kinks or

replace hose, if necessary.

NIBP DISABLED

A system error has occurred, and the X Series unit

should be serviced.

NIBP CALIBRATION CHECK DUE The annual calibration check is due. You can

continue to use the device, however, we recommend

that you contact your trained specialist or the ZOLL

Technical Service Department or a ZOLL authorized

service representative as soon as possible to

perform the recommended annual NIBP calibration

check.

PLEASE WAIT

8-14

After completing an NIBP request in Automatic mode

or STAT (TurboCuf) mode, the unit must wait up to

30 seconds before initiating the next NIBP

measurement request.

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NIBP System Messages

System Message

Cause

PRESS. LIMIT EXCEEDED

The cuff pressure has exceeded the allowable limit.

Restrict patient movement and check the hose for

kinks. Eliminate kinks or replace the hose, if

necessary.

TEMP OUT OF RANGE

The NIBP module is outside of its operating

temperature range. Move unit to proper operating

temperature and reattempt the NIBP measurement.

WEAK PULSE

The patient’s pulse is too weak to obtain an NIBP

measurement or the cuff requires adjustment.

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CHAPTER 8 MONITORING NON-INVASIVE BLOOD PRESSURE (NIBP)

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Chapter 9

Monitoring CO2

This chapter describes how to use the X Series unit to monitor End Tidal Carbon Dioxide

(EtCO2), breath rate, and Fractional Inspired Carbon Dioxide (FiCO2). These options use the

same connector on the X Series unit and may be used interchangeably.

Overview

The X Series unit uses the Oridion Microstream FilterLine® and Smart CapnoLine® sidestream

systems to monitor CO2.

The FilterLine and Smart CapnoLine sidestream systems draw small samples of gas from the

patient’s airway via a nasal/oral cannula or airway adapter, and pass these gases through a solid

state infrared sensor (located away from the patient’s airway) that measures CO2. The

Microstream system can be used for CO2 measurements on intubated and non-intubated infant,

pediatric, and adult patients.

The Microstream CO2 sensor generates infrared light, and beams it through the sampled

breathing gases and determines CO2 concentration by measuring the amount of light absorbed

by gases.

The X Series unit displays EtCO2 (the concentration of carbon dioxide detected at the end of

each exhalation) and FiCO as a numerical value in millimeters of mercury (mmHg). In

addition, the unit can display a capnogram. The capnogram is a valuable clinical tool that can

be used to assess patient airway integrity and proper endotracheal (ET) tube placement. The

unit calculates respiration rate by measuring the time interval between detected peaks of the

CO2 waveform. The technology differentiates between waveforms caused by breathing and

those caused by cardiogenic oscillations and artifact.

The X Series is equipped with automatic barometric pressure compensation.

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CHAPTER 9 MONITORING CO2

Warning!

Caution

•

When using a sampling line for intubated patients with a closed suction system, do

not place the airway adapter between the suction catheter and endotracheal tube.

This is to ensure that the airway adapter does not interfere with the functioning of

the suction catheter.

•

Do not cut or remove any part of the sample line. Cutting the sample line could lead

to erroneous readings

•

If too much moisture enters the sampling line (i.e., from ambient humidity or

breathing of unusually humid air), the message Clearing FilterLine will appear in

the message area. If the sampling line cannot be cleared, the message FilterLine

Blockage will appear in the message area. Replace the sampling line once the

FilterLine Blockage message appears.

•

Do NOT use the Microstream sidestream CO2 accessories in the presence of

flammable anesthetics or other flammable gases.

•

Loose or damaged connections may compromise ventilation or cause an inaccurate

measurement of respiratory gases. Securely connect all components and check

connections for leaks according to standard clinical procedures.

•

Always ensure the integrity of the patient breathing circuit after insertion of the

airway adapter by verifying a proper CO2 waveform (capnogram) on the monitor

display.

Microstream® EtCO2 sampling lines are designed for single patient use, and are not to be

reprocessed. Do not attempt to clean, disinfect, sterilize or flush any part of the sampling line as

this can cause damage to the monitor.

Dispose of sampling lines according to standard operating procedures or local regulations for the

disposal of contaminated medical waste.

Before use, carefully read the Microstream EtCO2 sampling line’s Directions for Use.

CO2 Monitoring Setup and Use

Follow these steps to set up CO2 monitoring:

1. Select the correct CO2 sampling line for the patient.

2. Attach the sampling line to the unit’s CO2 inlet port.

3. Apply the Filterline airway adaptor or Smart CapnoLine Nasal or Nasal/Oral cannula to the

patient.

4. Check that the X Series unit is set up for the correct patient type -- Adult, Pediatric, or

Neonate.

5. Configure alarms (if the current alarm settings are not appropriate) and other CO2 features.

CO

6. Press the CO2 quick access key (

)to initiate CO2 monitoring.

2

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CO2 Monitoring Setup and Use

Selecting the CO2 Sampling Line

To select the correct CO2 sampling line, you must determine the following:

• Is the patient adult, pediatric, or neonate?

• Is the patient intubated (ventilated) or non-intubated (non-ventilated)?

You can use the following Oridion Microstream accessories for sidestream CO2 monitoring

with the X Series unit:

Table 7-1. Oridion Microstream CO2 Sampling Lines for use with X Series units.

Warning!

Accessory

Type

Part Number

FilterLine Set (Adult/Pediatric), box of 25

Intubated sampling

line and airway

adapter for short

term monitoring

8300-0520-01

FilterLine H Set (Adult/Pediatric), box of 25

Intubated sampling

line and airway

adapter for humid

environments

8300-0521-01

FilterLine H Set (Infant/Neonate), box of 25

Intubated sampling

line and airway

adapter for humid

environments

8300-0522-01

VitaLine H Set (Adult/Pediatric), box of 25

Intubated sampling

line and airway

adapter for high

ambient humidity

8300-0523-01

Smart Capnoline Plus with O2 (Adult), box of 25 Non-Intubated Oral/

Nasal sampling with

O2 delivery

8300-0524-01

Smart Capnoline Plus with O2 (Pediatric),

box of 25

8300-0525-01

Non-Intubated

Dual Purpose

Use only CO2 Microstream accessories authorized by ZOLL Medical Corporation. ZOLL

Medical Corporation does not guarantee the use of non-authorized accessories.

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CHAPTER 9 MONITORING CO2

Connecting the CO2 Sampling Lines

To connect the FilterLine or Smart CapnoLine:

1. Slide open the X Series unit’s CO2 inlet port cover.

2. Put the fitting at the end of the sidestream tubing over the CO2 inlet port connector.

3. Turn the fitting clockwise to tighten.

Figure 9-1 Connecting the Sampling Line Connector to the CO2 Inlet Port

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CO2 Monitoring Setup and Use

WARNING! •

The exhaust port for the Microstream sidestream CO2 apparatus is an output for only

expired gases from the patient and any connected breathing apparatus. The exhaust

port is intended only for connection to gas collection equipment, such as gas scavenger

devices -- there should be no other connections to the exhaust port.

•

When connecting the Microstream sidestream CO2 accessory to patients who are

receiving or have recently received anesthetics, connect the CO2 exhaust port to a

scavenging system, or to the patient’s anesthetic machine or ventilator to prevent

exposing medical staff to anesthetics.

•

Do not lift the monitor by the FilterLine, as it could disconnect from the monitor,

causing the monitor to fall on the patient.

•

The FilterLine may ignite in the presence of high O2 concentrations when directly

exposed to laser or ESU devices. Use caution when performing these procedures.

Note:

Note:

If you use a gas scavenging system, ensure that it is installed according to the

manufacturers instructions. The gas scavenging system should comply with

ISO 8835-3:1997 (E).

In order to avoid moisture buildup and sampling line occlusion during nebulization or

suction for intubated patients, remove the sampling line luer connector from the

monitor.

Applying a FilterLine Set

The FilterLine set is intended for the CO2 monitoring of intubated patients.

Before attaching the airway adapter to the breathing circuit, verify that the adapter is clean, dry,

and undamaged. Replace if necessary.

Caution

The disposable FilterLine set is intended for single patient use. Do NOT reuse or sterilize any

part of the FilterLine Set, as the monitor may be damaged by cleaning or reuse.

1. Place the airway adapter at the proximal end of the airway circuit between the elbow and the

ventilator circuit wye. Do NOT place the airway adapter between the ET tube and the elbow

as this may allow patient secretions to accumulate in the adapter.

2. If pooling does occur, the airway adapter may be removed from the circuit, rinsed with water

and reinserted into the circuit. To prevent moisture from draining into the sample tubing,

ensure that the sampling tube exits from the top of the airway adapter, not its bottom or sides.

See the following figure.

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CHAPTER 9 MONITORING CO2

Applying a Smart CapnoLine Nasal or Nasal/Oral Cannula

The nasal and nasal/oral cannulas are intended for monitoring CO2 in non-intubated patients.

Oral/nasal sampling cannulas are especially valuable for patients who are prone to mouth

breathing, since most (if not all) of the CO2 is exhaled through the mouth. If a standard nasal

CO2 sampling cannula is used on such patients, the EtCO2 values and capnogram displayed will

be substantially lower than the actual CO2 levels present in the patient’s expired breath.

WARNING! •

•

The disposable Smart CapnoLine nasal and nasal/oral cannula sets are intended for

single patient use. Do NOT reuse or sterilize any part of this product, as the monitor

may be damaged by reuse of the sampling line.

If oxygen is being delivered while using sidestream CO2, be sure to use a CO2 sampling

with O2 delivery. Using a different type of cannula will not enable oxygen delivery.

Remove the cannula from the package. Verify that the cannula is clean, dry, and undamaged.

Replace if necessary.

Placing the Cannula onto the Patient

Place the oral/nasal cannula onto the patient as follows:

Caution

9-6

Dispose of Microstream EtCO2 consumables according to standard operating procedures or

local regulations for the disposal of contaminated medical waste.

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Measuring CO2

Measuring CO2

CO2

Once setup is complete, press

to begin monitoring CO2. The numeric CO2 display appears

on the screen and displays the message, INITIALIZING. The CO2 display gives the current

EtCO2 value, and after a delay of approximately 1 minute, the patient’s Respiration Rate (in

Breaths/Minute), identified as BR:

EtCO2

mmHg

36

BR

16

Check that connections have been made correctly by verifying the display a proper capnogram

(the waveform is inserted automatically on the waveform display window).

06/06/2011

I, II,

III...

II

12:34:56

Adult

00:17:43

1 cm/mV

12

CO2

R

SYNC

CO2

60

0 to 60 mmHg

30

0

HR

bpm NIBP

80 121

T1

98.6

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ºF

mmHg CO2

38

(96)

79

X Series Operator’s Guide

mmHg SpO2

BR

%

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CHAPTER 9 MONITORING CO2

Setting CO2 and Respiration Rate Alarms

The X Series unit sounds alarms whenever measurements are outside set limits for the

following:

• High and Low EtCO2

• High and Low Respiration Rate (in Breaths/Minute)

• High FiCO2

• No Breath Alarm

Note:

Use the Resp Parameter Control Panel to set the duration of the No Breath Alarm, or to

disable it (see “Using the Resp Parameter Control Panel” on page 7-4).

Enabling/Disabling Alarms and Setting CO2 Alarm Limits

You can enable (or disable) CO2 alarms and set upper and lower alarm limits through the

Alarms quick access key (

) or the CO2 Parameter Control Panel.

To configure CO2 alarms through the Alarms quick access key:

1. Press the More quick access key (

).

2. Press

.

3. Press the Limits quick access key (

).

4. Use the navigation buttons to select appropriate alarm menu. For CO2, the alarm menus are:

EtCO2 Alarm, FiCO2 Alarm, or RR/BR Alarm.

5. On the alarm settings menu, use the navigation keys to select the fields that you want to

change. The fields are

Limits

•

•

•

•

Upper Limit Enable

Lower Limit Enable (only EtCO2 and RR/BR Alarms)

Upper Limit

Lower Limit (only EtCO2 and RR/BR Alarms)

6. When you are finished changing values on the alarm menu, select the Backarrow key to exit

the menu.

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Setting CO2 and Respiration Rate Alarms

Setting Upper and Lower EtCO2 Limits

Initially, the EtCO2 Alarm menu specifies that the EtCO2 alarms are enabled (ON) or disabled

(OFF), and displays the default Upper and Lower EtCO2 Limits. The upper and lower limits can

be ON or OFF (default is OFF). The following table lists the default EtCO2 limits for adult,

pediatric, and neonate patients, and gives the range in which you can set these limits:

Patient Type

EtCO2 Limit Default

EtCO2 Limit Range

Adult

Lower: 8 mmHg

Lower: 0-145 mmHg

Upper: 60 mmHg

Upper: 5-150 mmHg

Lower: 8 mmHg

Lower: 0-145 mmHg

Upper: 60 mmHg

Upper: 5-150 mmHg

Lower: 8 mmHg

Lower: 0-145 mmHg

Upper: 60 mmHg

Upper: 5-150 mmHg

Pediatric

Neonate

Caution

In high-altitude environments, EtCO2 values may be lower than values observed at sea level, as

described by Dalton’s law of partial pressures. When using the X Series unit in high-altitude

environments, it is advisable to adjust EtCO2 alarm settings accordingly.

Setting Upper FiCO2 Limits

Initially, the FiCO2 Alarm menu specifies that the FiCO2 alarms are enabled (ON) or disabled

(OFF), and displays the default upper limit. The upper limit can be ON or OFF (default is OFF).

The following table lists the default FiCO2 upper limits for adult, pediatric, and neonate

patients, and gives the range in which you can set these limits:

Patient Type

Upper FiCO2 Limit

Default

Upper FiCO2 Limit

Range

Adult

8 mmHg

2-98 mmHg

Pediatric

8 mmHg

2-98 mmHg

Neonate

8 mmHg

2-98 mmHg

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CHAPTER 9 MONITORING CO2

Setting Upper and Lower Respiratory Rate (RR/BR) Limits

Initially, the RR/BR Alarm menu specifies that RR/BR alarms are enabled (ON) or disabled

(OFF), and displays the default Upper and Lower respiratory limits. The upper and lower limits

can be ON or OFF (default is OFF). The following table lists the default Respiratory limits for

adult, pediatric, and neonate patients in Breaths/Minute, and gives the range in which you can

set these limits:

Patient Type

Respiration Rate Default

Respiration Rate Range

Adult

Lower: 3 BPM

Lower: 0 to 145 BPM

Upper: 50 BPM

Upper: 5 to 150 BPM

Lower: 3 BPM

Lower: 0 to 145 BPM

Upper: 50 BPM

Upper: 5 to 150 BPM

Lower: 12 BPM

Lower: 0 to 145 BPM

Upper: 80 BPM

Upper: 5 to 150 BPM

Pediatric

Neonate

Using the CO2 Parameter Control Panel

Use the navigation keys to highlight and select the CO2 numeric display to display the

CO2 Parameter Control Panel:

CO2

CO2 Scale

Lower

Upper

EtCO2 Alarm0 to 30 mmHg

28

50

RR/BR Alarm

0 to 60 mmHg

10

30

0 to 100 mmHg

FiCO2 Alarm

0

10

0 to 150 mmHg

No Breath Alarm

CO2/Resp Sweep Speed

30 sec

12.5 mm/s

Figure 9-2 CO2 Parameter Control Menu

On the CO2 Parameter Control Panel, you can select a CO2 alarm (EtCO2, Breath Rate, or

FiCO2). On the selected alarm settings menu, you can enable/disable alarms and set alarm

limits (as described previously). You can also set the CO2 sweep speed.

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CO2 System Messages

Setting the CO2 Sweep Speed

The EtCO2 sweep speed determines the X-axis scale of the capnogram. For patients with

slower respiration rates, a slower sweep speed will make the capnogram easier to view. You can

specify sweep speeds of 3.13, 6.25, and 12.5 mm/second. The default sweep speed is

6.25 mm/second.

CO2 System Messages

When monitoring CO2, the X Series unit may display the following messages:

System Message

Cause

INITIALIZING

The unit is initializing the CO2 monitoring function

measurement, is functioning normally, and will display

CO2 measurement after a brief delay.

CHECK FILTERLINE

The sampling line is not connected. Check sampling line

connection. Replace airway adaptor or cannula, if

defective.

FILTERLINE OCCLUSION

The sampling or exhaust line is blocked. Check sampling

and exhaust lines. Make sure that the sampling line and

any inputs to the patient breathing apparatus are not

connected to the exhaust port. If the current FilterLine is

correctly attached, replace the FilterLine.

AUTO ZERO

The X Series unit displays AUTO ZERO when the CO2

module performs periodic self-maintenance. During selfmaintenance, the CO2 module performs one or more of

the following tests: ambient pressure measurement, auto

zero, and a flow test. The CO2 module completes its selfmaintenance tests in approximately 10 seconds.

PURGING

The CO2 module performs a purging whenever it detects

an occlusion in the line or airway adaptor, and displays

PURGING while it tries to clear the occlusion. If the CO2

module cannot clear the occlusion within 30 seconds, the

X Series unit issues an equipment alert and displays the

message FILTERLINE OCCLUSION. At this point, if the

current FilterLine is correctly attached, replace the

FilterLine.

VALUE OVER RANGE

The CO2 value exceeds the specified range.

CO2 DISABLED

An error has occurred with the CO2 module, and the X

Series unit has disabled the module for the duration of the

unit’s power cycle. If the problem persists, the unit may

require servicing.

CO2 MONITORING FAILURE

The X Series unit has determined that the CO2 module is

not functioning correctly. If the problem persists, the unit

may require servicing.

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CHAPTER 9 MONITORING CO2

Patents

The capnography component of the X Series unit is covered by one or more of the following

US patents: 6,428,483; 6,997,880;5,3000,859; 6,437,316; 7,488,229; and their foreign

equivalents. Additional patent applications pending.

NO IMPLIED LICENSE

Possession or purchase of this device does not convey any express or implied license to the

device with unauthorized consumable CO2 sampling consumable products, which would,

alone, or in combination with this device, fall within the scope of one or more of the patents

relating to this device and/or CO2 sampling consumable products.

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Chapter 10

Pulse CO-Oximetry (SpO2, SPCO, and SpMet)

The X Series SpO2 input is Type CF defibrillator proof.

This chapter describes how to use the X Series unit to monitor Pulse CO-Oximetry (SpO2), as

well as the optional features: SpCO and SpMet.

The X Series pulse CO-Oximeter continuously and noninvasively measures the oxygen

saturation of arterial hemoglobin (SpO2), carboxyhemoglobin saturation (SpCO), and

methemoglobin saturation (SpMet) at a peripheral site, such as the foot, toe, or finger. This

monitoring gives information about the cardiac and respiratory systems, and provides details of

oxygen transportation in the body. It is widely used because it is noninvasive, continuous,

easily applied, and painless.

The X Series pulse CO-oximetry option is intended for use only with ZOLL / Masimo Rainbow

sensors. The CO-oximetry sensor contains light-emitting diodes (LEDs) that transmit various

visible and infrared light through the body’s extremities. The transmitted light is then received

by a photodetector, which converts it to an electronic signal. The signal is then sent to the X

Series unit for processing.

Oxygen-saturated blood absorbs light differently than unsaturated blood. Thus the amount of

visible and infrared light absorbed by blood flowing through a suitable peripheral area of the

body, typically the finger in adults and the foot in neonates, can be used to calculate the ratio of

oxygenated hemoglobin to total hemoglobin in arterial blood. The monitor displays this ratio as

percent SpO2, alternating with SpCO and SpMet values. Normal SpO2 values typically range

from 95% to 100% at sea level. The SpCO and SpMet measurements rely on multiwavelength

calibration equations to estimate the percentages of carboxyhemoglobin and methemoglobin in

arterial blood.

The quality of measurements depends on the correct size and application of the sensor,

adequate blood flow through the sensor site, and the sensor’s exposure to ambient light. For

correct placement and location of the sensors, refer to the Directions for Use contained with all

Rainbow oximetry sensor packages.

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CHAPTER 10 PULSE CO-OXIMETRY (SPO2, SPCO, AND SPMET)

Warnings -- SpO2, General

• SpO2 style pulse oximeter measurements may be affected by numerous factors such as

bright lights, improperly applied probes, use of non-ZOLL approved sensors, patient

conditions/movements. The clinician should use good clinical judgment when

interpreting SpO2 measurements. Should the clinician question an SpO2

measurement, an arterial blood gas oxygen saturation measurement should be

obtained.

• Interfering substances: Carboxyhemoglobin and methemoglobin can erroneously alter

SpO2 readings. The level of change is approximately equal to the amount of

carboxyhemoglobin or methemoglobin present. Dyes or any substance containing dyes

that alter arterial pigmentation might cause erroneous readings.

• Do not use the X Series pulse oximeter or oximeter sensors during magnetic resonance

imaging (MRI). Induced current could cause burns. The pulse oximeter might affect

the MRI image and the MRI unit might interfere with the accuracy of oximetry

measurements.

• Carefully arrange patient cabling to reduce the possibility of patient entanglement or

strangulation.

• Inaccurate measurements may be caused by venous pulsations.

• The pulse oximeter can be used during defibrillation, but the readings may be

inaccurate for a short time.

• Pulse rate measurement is based on the optical detection of a peripheral flow pulse and

therefore may not detect certain arrhythmias. The pulse oximeter should not be used

as a replacement or substitute for ECG based arrhythmia analysis.

• Severe anemia may cause erroneous SpO2 readings.

• If using pulse CO-oximetry during full body irradiation, keep the sensor out of the

irradiation field. If the sensor is exposed to the irradiation, the reading might be

inaccurate or the unit might read zero for the duration of the active irradiation period.

• Elevated levels of Total Bilirubin may lead to inaccurate SpO2, SpMet, SpCO

measurements.

• Very low arterial Oxygen Saturation (SpO2) levels may cause inaccurate SpCO and

SpMet measurements.

• Loss of pulse signal can occur when:

- The sensor is too tight.

- The patient has hypotension, severe vasoconstriction, severe anemia, or

hypothermia.

- There is arterial occlusion proximal to the sensor.

- The patient is in cardiac arrest or is in shock.

• The pulsations from intra-aortic balloon support can be additive to the pulse rate on

the oximeter pulse rate display. Verify patient's pulse rate against the ECG heart rate.

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Warnings -- SpO2, Oximeter Sensor

Warnings -- SpO2, Oximeter Sensor

• Use only ZOLL-approved Masimo oximeter sensors. Other manufacturers’ sensors

might not perform properly with the X Series oximeter.

• Tissue damage can result from incorrect application or use of a sensor (for example,

wrapping the sensor too tightly, applying supplemental tape, failing to periodically

inspect the sensor site). To ensure skin integrity, correct positioning, and sensor

adhesion, inspect the sensor site as directed in the Directions for Use provided with the

sensor.

• Do not use damaged sensors or cables.

• Do not use a sensor with exposed optical components.

• Do not sterilize a sensor by irradiation, steam, or ethylene oxide. Refer to the cleaning

instructions in the Directions for Use for reusable Masimo sensors.

• Do not allow the sensor to remain on the same site for a prolonged period, especially

when monitoring neonates. Check the application site at regular intervals (at least

every 2 hours) and change the site if any compromise in skin quality occurs.

• Do not attach the oximeter sensor to a limb being monitored with a pressure cuff or

with restricted blood flow.

• A poorly applied sensor might give incorrect saturation readings. A weak pulse signal

on the display might indicate a poorly applied sensor or a poorly chosen monitoring

site.

• Choose a site with sufficient perfusion to ensure accurate oximetry values.

• Certain nail aberrations, nail polish, fungus, and so on might cause inaccurate

oximetry readings. Remove any nail polish or move the sensor to an unaffected digit.

• Exposure to high ambient light from surgical lamps (especially those with a xenon light

source), bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight

can affect the accuracy of oximetry readings. To prevent interference from ambient

light, ensure that the sensor is properly applied. If necessary, cover the sensor with

opaque material.

• Always remove the sensor from the patient and completely disconnect the patient from

the pulse CO-Oximeter before bathing the patient.

• Do not attempt to reprocess, recondition or recycle any Masimo sensors or patient

cables as these processes may damage the electrical components, potentially leading to

harm.Do not modify or alter the sensor in any way. Alterations or modification may

affect performance and/or accuracy.

• To avoid cross contamination only use Masimo single use sensors on the same patient.

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CHAPTER 10 PULSE CO-OXIMETRY (SPO2, SPCO, AND SPMET)

SpO2 Setup and Use

To take accurate SpO2 measurements using the X Series unit, you must perform the following

steps, each of which corresponds to a section in this chapter.

1. Select the correct SpO2 sensor.

2. Apply the SpO2 sensor to the patient.

3. Connect the sensor to the X Series unit.

4. Configure SpO2 alarms and settings (if the current SpO2 alarms and settings are not

appropriate).

Pulse oximetry measurements begin as soon as the sensor is applied to the patient and

connected to the X Series unit.

Selecting the SpO2 Sensor

When selecting the SpO2 sensor, consider the patient’s weight, the adequacy of perfusion, the

available sensor sites, and the anticipated duration of monitoring. For more information, refer

to the Accessories section of this chapter, which provides a list of ZOLL-approved reusable and

single-use SpO2 sensors for adult, pediatric, and neonate patients. Before applying the sensor,

always familiarize yourself with the Directions for Use that the manufacturer provides with the

sensor.

Applying the SpO2 Sensor

Choose a site that is well perfused and restricts a conscious patient's movements the least. The

ring finger or middle finger of the nondominant hand is preferred.

Alternatively, you can use the other digits on the nondominant hand. Be sure the sensor's

detector is fully covered by flesh. You can use the great toe or long toe (next to the great toe) on

restrained patients or patients whose hands are unavailable.

To prevent interference from ambient light, ensure that the sensor is properly applied, and cover

the sensor site with opaque material, if required. Failure to take this precaution in high ambient

light conditions may result in inaccurate measurements.

Do not select an SpO2 sensor site on the same arm/leg as an NIBP cuff. Inflation of the cuff will

cause the SpO2 values to read incorrectly.

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Applying the SpO2 Sensor

Applying a Two-Piece Single-Use Sensor/Cable

When applying a single-use SpO2 sensor, be careful not to wrap the adhesive too tightly as this

can cause venous pulsations that could lead to inaccurate saturation measurements.

1. Remove plastic backing from the sensor and locate transparent windows on the adhesive

side. The transparent windows cover the optical components. An index finger is the

preferred sensor location. Alternatively, apply the sensor to a small thumb, smaller finger, or

great toe.

Note:

When selecting a sensor site, priority should be given to an extremity free of an arterial

catheter, blood pressure cuff, or intravascular infusion line.

2. Orient the sensor so the dashed line in the middle of the sensor is centered on the tip of the

digit. Wrap adhesive flaps on non-cable end around the digit. Note that the cable must be

positioned on the top of the hand.

Detector Window

ZM 040024A

3. Fold cable end over top of digit so that windows are directly opposite each other. Wrap

adhesive securely around sides of digit.

Note:

If the sensor does not track the pulse reliably, it may be incorrectly positioned or the

sensor site may be too thick, thin, or deeply pigmented, or otherwise deeply colored

(for example, as a result of externally applied coloring such as nail polish, dye, or

pigmented cream) to permit appropriate light transmission. If any of these situations

occurs, reposition the sensor or choose an alternate sensor for use on a different site.

4. Lift the clear plastic protective cover from the female end of the extension cable, then plug

the sensor cable’s male connector into the extension cable connector -- make sure that the

plug is all the way into the connector:

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CHAPTER 10 PULSE CO-OXIMETRY (SPO2, SPCO, AND SPMET)

Sensor Cable Connector

Connector

Figure 10-1 Plug the Sensor Connectors Together

5. Lower the clear plastic cover over the connection to secure it:

Clear Protective

Cover

Figure 10-2 Lower Plastic Cover Over Cable Connection

6. See “Connecting the SpO2 Sensor” on page 10-8 to connect the cable to the unit.

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Applying the SpO2 Sensor

Applying a Reusable SpO2 Sensor/Cable

The following instructions describe how to apply a reusable Rainbow sensor. For all other

reusable sensors, refer to the sensor packaging and the manufacturer’s Directions for Use for

instructions on how to apply the sensor.

Note:

A reusable sensor is not intended for use on the thumb or across a child’s hand or foot.

After selecting a monitoring site, apply the reusable sensor as follows:

1. Place the selected digit over the sensor window, making sure that the sensor cable runs over

the top of the patient’s hand.

2. On finger sites, make sure the tip of the finger touches the raised digit stop inside the sensor.

If the fingernail is long, it may extend over and past the finger stop.

3. Check the sensor position to ensure that the top and bottom halves of the sensor are parallel.

To ensure accurate data, you must have complete coverage of the detector window.

Note:

With smaller digits, the digit may not need to be pushed all the way to the stop to

completely cover the detector window.

4. Based on the type of patient cable you are using, do one of the following:

If you are using a direct one-piece patient cable, see “Connecting the SpO2 Sensor” on

page 10-8.

• If you are using the two-piece patient cable, lift the clear plastic protective cover from

the female end of the extension cable, then plug the sensor cable’s male connector into

the extension cable connector -- make sure that the plug is all the way into the connector

(see Figure 10-1).

5. Lower the clear plastic cover over the connection to secure it (see Figure 10-2).

6. See “Connecting the SpO2 Sensor” on page 10-8 to connect the cable to the unit.

•

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CHAPTER 10 PULSE CO-OXIMETRY (SPO2, SPCO, AND SPMET)

Cleaning and Reuse of Sensors

Reusable sensors can be cleaned as follows:

Disconnect the sensor from the patient cable, if appropriate. Wipe the entire sensor clean with a

70% isopropyl alcohol moistened pad. Allow the sensor to air dry before returning it to use.

Connecting the SpO2 Sensor

To connect the SpO2 sensor to the X Series unit:

1. When using a sensor extension cable, inspect the cable before use. Replace the cable if it

shows any signs of wear, breakage, or fraying. Plug the sensor extension cable into the SpO2

receptacle on the side of the X Series unit:

Figure 10-3 Connecting the SpO2 Sensor to the X Series Unit

Displaying SpO2, SpCO, and SpMet Measurements

When the connection is made between the SpO2 sensor and the unit, the message,

INITIALIZING, appears in the SpO2 display. After a brief delay, the unit displays the SpO2