Philips HeartStart MRx User manual (2005)

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M3535A/M3536A Instructions for Use

HeartStart MRx

1Table of Contents

1 Introduction 3

Overview 3 Intended Use 5

Defibrillation Therapy 5 Synchronized Cardioversion Therapy 5 Noninvasive Pacing Therapy (Optional) 5 12-Lead ECG Analysis (Optional) 6 Noninvasive Blood Pressure (NBP) Monitoring (Optional) 6 CO2 Monitoring (Optional) 6 Pulse Oximetry (SpO2) Monitoring (Optional) 6

Indications for Use 7 Safety Considerations 8 Documentation and Training 8

2 Getting Acquainted 9

Basic Orientation 10

Front Panel 10 Side Panels 11 Top Pa n e l 12 Back Panel 13

M3538A Lithium Ion Battery 14

Battery Capacity 14 Battery Life 14

Operating Modes 14

Password Security 15

Display Views 15

General Status 16 Wave Se ct or s 17 Parameter Blocks 18 Soft Key Labels 18 Display Menus 19 Message Windows 19 High Contrast Display 20

Controls 20

Therapy Knob 20 General Function Buttons 21 Defibrillation Controls 22 Soft Keys 22 Indicators 23

Responding to Alarms 24 Entering Patient Information 25 Continued Use 25 Return to Owner 26

3 Setting Up 27

Attaching the Carrying Case and Accessory Pouches 27 Storing Accessories 29 Connecting the ECG Cable 31 Connecting the SpO2 Cable 32 Connecting the NBP Interconnect Tubing 33 Connecting the CO2 Nasal FilterLine Connecting the Therapy Cable 35 Installing Paper 36

50mm Printer 36 75mm Printer 37

Installing Batteries 38

Charging Batteries 38 Battery Safety 38

Installing the AC Power Module 39 Installing the Data Card 40

4 ECG and Arrhythmia Monitoring 41

Overview 41 Monitoring View 42 Preparing to Monitor ECG 43 Electrode Placement 45 Lead Selection 47

Lead Choices 47 Selecting the Lead 48

Arrhythmia Monitoring 48

Aberrantly-Conducted Beats 49 Intermittent Bundle Branch Block 49

Heart Rate and Arrhythmia Alarms 50

Arrhythmia Alarm Latching 50 INOP Messages 51

Setting Alarms 52

Changing Heart Rate or Vtach Alarm Limits 52 Enabling/Disabling Heart Rate and Arrhythmia Alarms 52

Responding to HR and Arrhythmia Alarms 52 Displaying an Annotated ECG 53 Arrhythmia Learning/Relearning 54 Troubleshooting 54

5 Semi-Automated External Defibrillation 55

AED View 56 Preparation 57 Using AED Mode 59

Step 1 - Turn the Therapy Knob to AED 59 Step 2 - Follow the Screen and Voice Prompts 60 Step 3 - Press the Orange Shock Button, if Prompted 62

Troubleshooting 63

6 Manual Defibrillation and Cardioversion 65

Overview 65 Code View 66 Preparing for Defibrillation 67

Using Multifunction Electrode Pads 67 Using External Paddles 68 Using Pediatric Paddles 69 Using Internal Paddles 69

Defibrillating (asynchronously) 70 Performing Synchronized Cardioversion 72

Preparing for Synchronized Cardioversion 72 Delivering a Synchronized Shock 73 Delivering Additional Synchronized Shocks 74 Disabling the Sync Function 74

Troubleshooting 74

7 Noninvasive Pacing 75

Overview 75 Alarms 76 Pacing View 77 Demand Mode Versus Fixed Mode 78 Preparing for Pacing 79 Demand Mode Pacing 80 Fixed Mode Pacing 81 Defibrillating During Pacing 82 Troubleshooting 82

iii

8 Pulse Oximetry 83

Overview 83 Understanding Pulse Oximetry 84 Selecting a Sensor 85 Applying the Sensor 87 Monitoring SpO

Pleth Wave 89

Setting SpO2 Alarms 90

Changing the SpO2 Alarm Limits 90 SpO2 Desat Alarm 90 Enabling/Disabling the SpO2 Alarms 90

Setting Pulse Rate Alarms 91

Enabling/Disabling the Pulse Rate Alarms 91 Changing the Pulse Rate Alarm Limits 91

Disabling the SpO2 Monitoring Function 92 Caring for Sensors 92 Troubleshooting 92

9 Noninvasive Blood Pressure 93

Overview 93 Preparing to Measure NBP 94 Measuring NBP 96

Changing the NBP Schedule 96

Alarms 97

Changing NBP Alarms 97 Enabling/Disabling NBP Alarms 97

Troubleshooting 97

10 Monitoring Carbon Dioxide 99

Overview 99 Preparing to Measure EtCO

Selecting the Accessories 100

Setting Up Microstream EtCO2 Measurements 101

Using the Nasal FilterLine 101 Using the FilterLine and Airway Adapter 101

Measuring EtCO

Setting Up the EtCO2 and AwRR Alarms 102

Changing the EtCO2 Alarm Limits 103 Enabling/Disabling the EtCO2 Alarms 103 Changing the AwRR Alarm Limits 103 Changing the Apnea Time Alarm Limit 104 Enabling/Disabling AwRR Alarms 104

Disabling the EtCO2 Monitoring Function 104 Troubleshooting 104

100

102

11 12-Lead ECG 105

Overview 105 Preview Screen 106 Preparation 106 Acquiring the 12-Lead ECG 108 12-Lead Report 109

Accessing Stored Reports 109

Improving Signal Quality 111

Adjusting Wave Size 111

12-Lead Filters 112 Troubleshooting 112

12 12-Lead ECG Transmission 113

Overview 113 Setting Up for Bluetooth Transmission 115

Adding a Bluetooth Device 115 Pairing a Bluetooth Device with the HeartStart MRx 115 Changing Bluetooth Profiles 116 Additional Bluetooth Device Information 116

Transmitting to a Configured Site using Bluetooth 117 Setting Up for RS 232 Transmission 118 Transmitting to a Configured Site Using RS 232 120 Transmitting to a Manually Entered Fax Number 121 Transmission Status 122 Transmitting Stored 12-Lead Reports 123 Cancelling Transmission 123 Troubleshooting 124

13 Configuration 125

Overview 125 Accessing the Configuration Menu 125 Setting the Date and Time 126 Modifying Settings 126 Saving Configuration Settings to a Data Card 127 Loading Configuration Settings from a Data Card 127 Restoring the Default Settings 127 Printing Configuration Settings 127 Configurable Parameters 128

14 Data Management 141

Overview 141 Copying from Internal Memory 142 Viewing and Erasing the Data Card 142 Printing the Event Summary 143 Printing the 12-Lead ECG Report 143 Events Recorded 144 Marking Events 148 Printing Events 149

15 Maintenance 151

Overview 151 Automated Tests 152

Automated Test Summary 153

Ready For Use Indicator 155 Shift Checklist and Operational Check 156

Weekly Shock Test 156

Operational Check (Versions Prior to B.05) 157

Performing the Operational Check 157 Operational Check Report for Versions Prior to B.05 162 Operational Check Summary 165

Operational Check (Versions B.05 and Greater) 166

Performing the Operational Check 167 Operational Check Report for Versions B.05 or Greater 173 Operational Check Summary 177

Battery Maintenance 178

Battery Capacity 178 Battery Life 178 Charging Batteries 179 Battery Calibration 179 Storing Batteries 180 Discarding Batteries 181

Cleaning Instructions 182

Monitor/Defibrillator 182 Printer Printhead 182 Paddles, Therapy Cable 183 ECG Cable 183 Carrying Case 184 NBP Cuff 184 SpO2 Sensor and Cable 184

Disposing of the HeartStart MRx 185

Disposing of Empty Calibration Gas Cylinders 185

Supplies and Accessories 186

16 Troubleshooting 193

Symptoms 194 Audio Tones and Alarm Indications 210 Calling for Service 211

17 Specifications and Safety 213

Specifications 213

General 213 Defibrillator 213 ECG and Arrhythmia Monitoring 216 Display 218 Battery 218 Thermal Array Printer 219 Noninvasive Pacing 219 SpO2 Pulse Oximetry 220 NBP 221 EtCO2 221 AwRR 222 Calibration Gas for CO2 Measurement System 223 12-Lead ECG 223 Patient Data Storage 223 Environmental (M3535A) 223 Environmental (M3536A) 225 Symbol Definitions 227

Clinical Performance Summary - Defibrillation 230

Methods 230 Results 230 Conclusion 230

Clinical Performance Summary - Cardioversion 231

Methods 231 Results 231 Conclusion 232

Clinical Performance Summary - Internal Defibrillation 233

Overview 233 Methods 233 Results 233 Conclusion 233

vii

Safety Considerations 234

General 234 Defibrillation 236 Battery 237 Supplies and Accessories 238

Electromagnetic Compatibility 238

Reducing Electromagnetic Interference 238 Restrictions for Use 239 Emissions and Immunity 239 Guidance and Manufacturer’s Declaration 239

Index 247

viii

Notice

About This Edition

Edition 4

Printed in the USA

Publication number M3535-91900

To determine the product level version to which the Instructions for Use are applicable, refer to the version level appearing on the back cover of this book or on the label of the User Documentation CD-ROM that accompanied this device. This information is subject to change without notice.

Philips shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this material.

Edition History

Edition Print Date

1 December, 2003

2 June, 2004

3 October, 2004

4 October, 2005

Medical Device Directive

The HeartStart MRx complies with the requirements of the Medical Device Directive 93/42/EEC and carries the

mark accordingly.

0123

Manufacturer

Philips Medical Systems 3000 Minuteman Road Andover, MA 01810

Authorized EU-representative

Philips Medizin Systeme Böblingen GmbH Hewlett Packard Str. 2 71034 Böblingen Germany

Canada EMC:ICES-001

For the Declaration of Conformity Statement, please see the Philips Medical web site at http:// incenter.medical.philips.com/PMSPublic. Scroll over the Quality and Regulatory Tab located in the upper left corner of the window. Click to select Regulatory by Modality. Then click to select Defibrillators and select the entry for Declaration of Conformity (DoC)

War ning

Koninklijke Philips Electronics N.V.

All rights are reserved. Permission is granted to copy and distribute this document for your organization’s internal educational use. Reproduction and/or distribution outside your organization in whole or in part is prohibited without the prior written consent of the copyright holder.

SMART Biphasic is a registered trademark of Philips.

Use of supplies or accessories other than those recommended by Philips may compromise product performance.

THIS PRODUCT IS NOT INTENDED FOR HOME USE.

IN THE U.S., FEDERAL LAW RESTRICTS THIS DEVICE TO SALE ON OR BY THE ORDER OF A PHYSICIAN.

Radio frequency (RF) interference from nearby transmitting devices may degrade the performance of the HeartStart MRx. Electromagnetic compatibility with surrounding devices should be assessed prior to using the monitor/defibrillator.

These Instructions for Use contain the following conventions:

WARNING Warning statements describe conditions or actions that can result in personal injury or loss of life.

CAUTION Caution statements describe conditions or actions that can result in damage to the equipment or loss of

data.

NOTE Notes contain additional information on usage.

"Voice" represents voice prompt messages

Text represents messages that appear on the display

[Soft key] represents soft key labels that appear on the display above the

button to which they correspond.

Thank you for choosing the HeartStart MRx monitor/defibrillator. Philips Medical Systems welcomes you to its family of resuscitation devices.

The HeartStart MRx is designed to meet your monitoring and resuscitation needs by providing advanced, multi-parameter monitoring functions and a full range of defibrillation therapies. This guide provides instructions for the safe and proper operation of the device, as well as set-up, configuration, and maintenance information.

Be sure to familiarize yourself with the features and operation of the HeartStart MRx prior to its use.

Overview

The HeartStart MRx is a lightweight, portable, monitor/defibrillator. It provides four modes of operation: Monitor, Manual Defib, AED, and Pacer (optional).

1Introduction

In Monitor Mode you can monitor up to four ECG waveforms, acquired through a 3-, 5-, or 10-lead ECG set. Optional monitoring of pulse oximetry (SpO carbon dioxide (EtCO display and alarms are available to alert you to changes in the patient’s condition.

Monitor Mode also provides an optional 12-Lead ECG function, enabling you to preview, acquire, store, and print 12-lead ECG reports, with or without analysis/interpretation.

Manual Defib Mode offers simple, 3-step defibrillation. You analyze the patient’s ECG and, if appropriate: 1) select an energy setting, 2) charge, and 3) deliver the shock. Defibrillation may be performed using paddles or multifunction electrode pads. Manual Defib Mode also allows you to perform synchronized cardioversion and internal defibrillation. If desired, use of Manual Defib Mode may be password protected (for Version A.02 and later devices).

In AED Mode, the HeartStart MRx analyzes the patient’s ECG and determines whether a shock is advised. Voice prompts guide you through the 3-step defibrillation process, providing easy-to-follow instructions and patient information. Voice prompts are reinforced by messages that appear on the display.

Both Manual Defib and AED Mode incorporate the Philips’ low energy SMART Biphasic waveform for defibrillation. The Q-CPR™ option, available in both Manual Defib and AED Modes, offers realtime, measurement and corrective feedback on the rate, depth, and duration of CPR compressions, as well as the frequency and volume of ventilations. It also provides notification of lack of CPR activity. For more information about Q-CPR refer to the Instructions for Use Addendum for Q-CPR.

NOTE Q-CPR™ is a trademark of Laerdal Medical.

) are also available. Measurements from these parameters are presented on the

), noninvasive blood Pressure (NBP), and

1 Introduction Overview

Optional Pacer Mode offers noninvasive transcutaneous pacing therapy. Pace pulses are delivered through multifunction electrode pads, using a monophasic waveform. If desired, use of Pacer Mode may be password protected (for Version A.02 and later devices).

The HeartStart MRx is powered by rechargeable lithium ion batteries. Available battery power is easily determined by viewing the convenient battery power indicators located on the device display or by checking the gauge on the battery itself. Additionally, an external AC or DC Power Module may be applied as a secondary power source and for continual battery charging.

The HeartStart MRx performs Automated Tests on a regular basis. The results of these tests are reported to the Ready For Use (RFU) indicator. Prominently displayed, the RFU indicator communicates the status of your device, letting you know it is operating correctly, needs attention, or is unable to deliver therapy. In addition, performing the specified Operational Check ensures that the HeartStart MRx is functioning properly.

The HeartStart MRx automatically stores critical event data in its internal memory, such as Event Summaries and 12-Lead Reports. The HeartStart MRx also enables you to store data and event information on an optional data card for downloading to Philips’ data management solution, HeartStart Event Review Pro.

The HeartStart MRx is highly configurable to better meet the needs of diverse users. Be sure to familiarize yourself with your device’s configuration before using the HeartStart MRx. See “Configuration” on page 125.

Intended Use 1 Introduction

Intended Use

The HeartStart MRx is for use in hospital and pre-hospital settings by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support or defibrillation.

When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart MRx is suitable for use by medical personnel trained in basic life support that includes the use of an AED.

When operating in Monitor, Manual Defib or Pacer Mode, the HeartStart MRx is suitable for use by healthcare professionals trained in advanced cardiac life support.

Defibrillation Therapy

Defibrillation therapy is the definitive method for termination of a variety of potentially fatal arrhythmias. The HeartStart MRx provides this therapy through the application of a brief biphasic pulse of electricity to the cardiac muscle. This electrical energy is transferred through attached paddles or disposable multifunction electrode pads applied to the patient’s bare chest.

NOTE Successful resuscitation is dependent on many variables specific to the patient’s physiological state and

the circumstances surrounding the patient event. Failure to have a successful patient outcome is not a reliable indicator of monitor/defibrillator performance. The presence or absence of a muscular response to the transfer of energy during electrical therapy is not a reliable indicator of energy delivery or device performance.

Precautions for Manual Defibrillation Therapy

Defibrillating asystole can inhibit the recovery of natural pacemakers in the heart and completely eliminate any chance of recovery. Asystole should not be routinely shocked.

Precautions for AED Therapy

The AED algorithm is not designed to handle erratic spiking problems caused by a properly or improperly functioning pacemaker. In patients with cardiac pacemakers, the HeartStart MRx may have reduced sensitivity and not detect all shockable rhythms.

NOTE The HeartStart MRx AED mode is not intended for children under 8 years of age. For children older

than 8 years, the American Heart Association recommends that standard operating procedures for AEDs be followed. See the American Heart Association Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Dallas, Texas; AHA; 2000.

Synchronized Cardioversion Therapy

The HeartStart MRx provides synchronized cardioversion therapy by delivering a biphasic, electrical stimulus to the heart immediately following an R-wave detected in the ECG measurement. The SMART Biphasic waveform utilized in the HeartStart MRx has undergone clinical testing demonstrating its effectiveness for cardioversion of atrial fibrillation.

Noninvasive Pacing Therapy (Optional)

The HeartStart MRx provides noninvasive transcutaneous pacing by delivering a monophasic, electrical stimulus to the heart. This stimulus is intended to cause cardiac depolarization and myocardial contraction. The medical care provider selects the stimulus output and rate settings. The energy is delivered through multifunction electrode pads applied to the patient’s bare chest.

1 Introduction Intended Use

12-Lead ECG Analysis (Optional)

The HeartStart MRx 12-lead ECG function uses the Philips 12-Lead Algorithm to analyze acquired 12-lead ECG signals from adult and pediatric patients. The algorithm provides an analysis of amplitudes, durations, and morphologies of the ECG waveforms and the associated rhythm, based on the age and sex of the patient. Measurements and interpretive statements are offered to the clinician on an advisory basis only. This information is to be used in conjunction with the clinician’s knowledge of the patient, the results of the physical examination, the ECG waveforms, and other clinical findings.

Noninvasive Blood Pressure (NBP) Monitoring (Optional)

Oscillometric devices measure the amplitude of pressure changes in the occluding cuff as the cuff is deflated from above the systolic pressure. The amplitude suddenly increases as the pulse breaks through the occlusion in the artery. The pressure at which this occurs is very close to the systolic pressure. As the cuff pressure is decreased further, the pulsations increase in amplitude, reach a maximum (which approximates to the mean pressure), and then diminish rapidly. The index of diastolic pressure is taken where this rapid transition begins.

Studies have shown that, especially in critical cases (arrhythmia, vasoconstriction, hypertension, shock), oscillometric devices are more accurate and consistent than devices using other noninvasive measuring techniques.

The readings obtained from automatic oscillometric devices almost always deviate from those produced by the auscultatory technique. It is of particular importance to understand these deviations in environments such as Emergency and Recovery Departments where comparisons with intra-arterial measurements are seldom available.

CO2 Monitoring (Optional)

Capnometry is the measurement and numerical display of end-tidal CO2 (EtCO2) or the maximum expired CO the concentration or partial pressure of expired CO The capnograph provides information not only regarding pulmonary function, but also indirect cardiac function, ventilator function and perfusion.

concentration during a respiratory cycle. The capnograph is a graphical representation of

during a respiratory cycle in a “waveform” format.

Pulse Oximetry (SpO2) Monitoring (Optional)

A pulse oximeter is a noninvasive device that indicates the oxygen saturation (SpO2) of arterial blood. This measurement is obtained through a probe that directs red and near infrared light through arterial beds. Hemoglobin absorbs these lights differently when it is bound with oxygen. Pulse oximetry measures this difference and translates the measurement into a saturation percentage that is displayed as an SpO

reading.

Indications for Use 1 Introduction

Indications for Use

The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation.

The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.

The SMART Biphasic waveform utilized in the HeartStart MRx has previously undergone clinical testing in adults. These trials support the waveform’s effectiveness for defibrillation of ventricular tachyarrhythmias at 150J. There are currently no clinical studies related to the use of the SMART Biphasic waveform in pediatric applications.

Manual Defibrillation

Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients who are pulseless and unresponsive. Synchronous defibrillation is indicated for termination of atrial fibrillation.

Asynchronous defibrillation therapy is contraindicated in patients that exhibit one or any combination of the following:

• Responsiveness

• Spontaneous breathing

•Palpable pulse

AED Therapy

An AED is to be used in the presence of a suspected cardiac arrest on patients of at least 8 years of age that are:

• Unresponsive

•Not breathing

•Pulseless

An AED is not to be used on patients that exhibit one or any combination of the following:

• Responsiveness

• Spontaneous breathing

•Palpable pulse

Noninvasive Pacing Therapy

The pacing option is intended for treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early.

Noninvasive pacing is contraindicated in the treatment of ventricular fibrillation. Noninvasive pacing in the presence of severe hypothermia may be contraindicated.

1 Introduction Safety Considerations

12-Lead ECG

The 12-Lead ECG function is to be used where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule out causes for symptoms.

Noninvasive Blood Pressure

The NBP option is intended for use to determine the noninvasive measurement of arterial blood pressure for adult and pediatric patients.

NBP monitoring is contraindicated in neonatal patients or infants whose upper arm circumference is less than 13 cm.

End-tidal CO

The EtCO2 option is intended for noninvasive monitoring of exhaled carbon dioxide (EtCO2) and to provide a respiration rate for adult, pediatric, and neonatal patients.

Pulse Oximetry

The SpO2 option is intended for use when it is beneficial to assess oxygen saturation level for adult and pediatric patients.

Safety Considerations

General warnings and cautions that apply to use of the HeartStart MRx are provided in “Specifications and Safety” on page 213. Additional warnings and cautions specific to a particular feature are provided in the appropriate section of this guide.

WARNING Electric shock hazards exist internally. Do not attempt to open the device. Refer servicing to qualified

personnel.

Documentation and Training

Available documentation and training for the HeartStart MRx includes:

• HeartStart MRx Instructions for Use

• HeartStart MRx Quick Reference Cards

• HeartStart MRx Battery Application Note

• HeartStart MRx Web-based User Training (Located at:

www.medical.philips.com/goto/mrxtraining. Enter training access password: meetMRx.)

• HeartStart MRx User Training Video

Other Application Notes can be found on the Philips website at: www.medical.philips.com/goto/productdocumentation.

2Getting Acquainted

The HeartStart MRx is designed with your needs in mind. Controls, indicators, and menus are carefully organized to facilitate ease of use, and display information is tailored to the current task.

This chapter will acquaint you with the HeartStart MRx operational modes, display views, controls, and indicators. It also provides general information on use of the device.

NOTE If your HeartStart MRx does not have optional SpO

or 12-lead ECG transmission functionality, disregard these controls and the related information described in this chapter.

, CO2, NBP, Pacing, 12-lead ECG acquisition,

2 Getting Acquainted Basic Orientation

Basic Orientation

HeartStart MRx controls, indicators, and connections are carefully organized to facilitate ease of use.

Front Panel

The front panel contains operational controls and indicators, as shown below.

Figure 1 Basic Orientation (Front)

Label Recess

Mark Event button

Lead Select button

Display

External Power Indicator

Synchronized Cardioversion (Sync) Button

1-10

acer

onitor

A D

120

150

100

AED

Ready For Use (RFU) Indicator

Therapy Knob

dult ose

170

200

elect

nergy

harge

CHARGE button

SHOCK button

hock

Printer (50 mm)

Printer Door

Latch

Print button

Speaker

Alarm Pause button

Event Summary button

Soft keys (4 total)

Navigation buttons

Menu Select button

The front panel also contains the printer and speaker.

Additional controls and indicators are on the paddles (if used) and batteries.

NOTE A palette of colored decals is included with your HeartStart MRx. These colored decals may be applied

to the label recesses located on the device handle to aid in identification. Use an indelible marker to print identification information on the decal.

Basic Orientation 2 Getting Acquainted

Side Panels

The left side of the HeartStart MRx has ports for monitoring cables, including ECG, pulse oximetry

). The ECG port may be used to

Therapy Connector

CO2 Inlet Port

CO2 Outlet Port

(SpO2), noninvasive blood pressure (NBP), and carbon dioxide (CO connect a 3-, 5-, or 10-lead patient cable. The ECG Out jack may be used to connect to an external monitor. There is also a telephone jack (for future use).

The right side of the HeartStart MRx has a therapy port for paddles (external or internal) or multifunction electrode pads. It also has a slot for a data card to transfer patient information.

Figure 2 Basic Orientation (Right/Left Sides)

™

NBP Port

ECG Port

SpO2 Port

Data Card

ECG Out (Sync) Jack

RJ11 Telephone

Jack

2 Getting Acquainted Basic Orientation

Top Panel

The top of the HeartStart MRx has a handle and basic operating instructions. If optional external paddles are present, they reside on the top panel as shown.

Figure 3 Basic Orientation (Top - with Optional Paddles)

Basic Orientation 2 Getting Acquainted

Back Panel

The back panel of the HeartStart MRx has two compartments for lithium ion batteries. Compartment B may instead be used to connect an AC power module. Between the battery compartments is a DC Power Input port.

The back panel also has an RS 232 serial port for 12-lead ECG transmission. The LAN port is for factory use only.

Figure 4 Basic Orientation (Back)

Battery/AC Compartment B

Battery Compartment

AN Connection

Battery

RS 232 Serial Port

AC Power Module

DC Power Input

2 Getting Acquainted M3538A Lithium Ion Battery

M3538A Lithium Ion Battery

The HeartStart MRx uses the M3538A Lithium Ion Battery. The battery has a fuel gauge with 5 LED indicators, each representing a charge of approximately 20% of capacity. Press the fuel gauge button to illuminate the fuel gauge.

NOTE A battery should be used as the primary power source, with AC/DC as a secondary source, if desired. If

an AC/DC power module is used as the only power source, the HeartStart MRx will take longer to charge to the desired energy level.

Battery Capacity

A new, fully-charged M3538A battery, operating at room temperature 25oC(77oF), provides approximately 5 hours of monitoring, with ECG, SpO measured every 15 minutes, or at least 50 full-energy discharges.

Battery Life

Battery life depends on the frequency and duration of use. When properly cared for, the M3538A Lithium Ion battery has a useful life of approximately 2 years. To optimize performance, a fully (or nearly fully) discharged battery should be charged as soon as possible.

and CO2 monitored continuously and NBP

Operating Modes

The HeartStart MRx has four clinical modes of operation, each with a customized display view. The modes are as follows:

Table 1 Operating Modes and Views

Mode of Operation Display View Description

Monitor Mode Monitoring View, or

12-Lead View

AED Mode AED View Used to analyze ECG and if necessary,

Manual Defib Mode Code View Used to perform asynchronous and

Pacer Mode Pacing View Used to perform demand or fixed mode

NOTE Upon returning to a clinical mode from a non-clinical mode such as Configuration or Data

Management, all settings are re-set to the device’s default values.

Used to monitor ECG, take an optional 12-lead ECG, and monitor optional parameters such as SpO

perform semi-automatic external defibrillation.

synchronous defibrillation (cardioversion).

pacing.

, EtCO2 and NBP.

Display Views 2 Getting Acquainted

Password Security

Access to Manual Defib Mode and Pacer Mode may be password protected (for Version A.02 and later devices) if enabled in Configuration. If enabled, you will be prompted to enter the password upon moving the Therapy Knob to either the Pacer position or an energy selection. The password is entered by using the Navigation buttons to select the password numbers and then selecting Done to complete the entry. The Charge button and the [Start Pacing] soft key remain inactive until the

harge

password is entered.

WARNING Use of the Manual Therapy Security password requires the clinician to know and remember the

password, as defined in Configuration. Failure to enter the correct password will prevent the delivery of manual defibrillation or pacing therapy. Prior to selecting this Configuration option, review this potential risk with your Risk Manager.

Display Views

The HeartStart MRx display layout is segmented as shown in Figure 5.

Figure 5 Display Layout

General Status Area

Mark Event

Inops Area

ECG/HR alarms (R or Y)

HRHR

000000

Wav e Sector 1

Wav e Sector 2

Wav e Sector 3

Wav e Sector 4

Soft Keys

ECG Wave 1ECG Wave 1

Wave 2Wave 2

SpO2SpO2 etCO2

100

Wave 3

Wave 4

Softkey#1Softkey#2Softkey#3Softkey

100

120120

6060

Pulse

000

02 Mar 2003 10:52Adult Paced

HH:MM:SS

NBP q 30 10:40

000/000(000)

AwRR

000

120

SYS

160

rhythm statusrhythm status

Main Menu

Volume

Waves

Measurements/Alarms

Patient Info

Other

Exit

Parameter Block 1

Parameter Block 2

Menu Area

The content of these areas varies with the display view and the function being performed.

2 Getting Acquainted Display Views

General Status

The general status area of the display contains:

• Mark Event button label

• Patient information

Some modes of operation allow for the entry of patient information via a menu choice. If no information is entered, the patient category is defaulted to Adult, unless configured otherwise, and the pacing status is set to Non-Paced, unless the Paced status is set to Paced for an internally paced patient, or the HeartStart MRx is pacing the patient. In Pacer Mode, Paced status is not displayed.

• Date and time

• Battery power indicators

Battery icons, labeled “A” and “B”, correspond with the battery compartments located at the back of the HeartStart MRx. Each battery icon displays the current available battery power, ranging from hollow (fully discharged) to full (fully charged), as shown in Figure 6. If the AC Power Module is inserted in Compartment B, the no battery icon is displayed.

Figure 6 Battery Charge Level Indicators

No Battery Empty Battery 25% Capacity 50% Capacity 75% Capacity 100% Capacit

AAA

• Inop statements

Inop statements appear in the top left of the display if equipment problems are detected.

• ECG/HR alarm status

Alarm messages communicate arrhythmia alarms, as well as overall alarm status (alarms off, alarms paused).

•Event Timer

An Event Timer communicates the elapsed time since the device was turned on.

Display Views 2 Getting Acquainted

Wave Sectors

The HeartStart MRx is configured to populate each wave sector with a predetermined waveform, when powered on in Monitor, Manual Defib, or Pacer Mode. Figure 7 shows the default Waves configuration choices. See “Configuration” on page 125 for more information.

A dashed line in a wave sector or an empty wave sector indicates that the waveform source is not connected to the HeartStart MRx. Wave sectors may contain a variety of information, as appropriate to the parameter, view, and task. Additionally, ECG wave sectors contain a calibration bar.

Figure 7 Default Waves Configuration

Wave Sector 1

Wave Sector 1 will only contain an ECG waveform. This is the waveform used by the arrhythmia, heart rate derivation, and AED analysis algorithms. This waveform may be acquired through the therapy port for pads/paddles or the monitoring port for 3-, 5-, or 10-lead electrodes. If the configured source is not connected to the HeartStart MRx when turned on, the first valid ECG source is displayed in Wave Sector 1. Once the configured source is available, it automatically populates Wave Sector 1. Should the configured source then become invalid, a Leads Off condition is displayed. The HeartStart MRx does not revert to the initial source of ECG.

NOTE If Pads are configured as the primary ECG source for Wave Sector 1, the ECG patient cable must be

connected to the MRx and to the monitoring electrodes on the patient in order to change the ECG source to a Leads selection.

NOTE When monitoring using a 3-lead ECG set, the MRx displays only 1 ECG lead at a time.

2 Getting Acquainted Display Views

Wave Sectors 2-4

Wave Sectors 2 through 4 are automatically populated when parameter sources (cables/tubing) are connected to the HeartStart MRx. If the parameter source is the configured choice of a particular wave sector, it is displayed in that wave sector. If you connect a parameter source that is not configured to be displayed, it is displayed in the first empty wave sector. If you subsequently connect the configured parameter source, it does not replace the current parameter, instead it populates the first available empty wave sector.

Changing Displayed Waveforms

Wave Sector 1 has a dedicated Lead Select button to change the displayed lead/source. Waveforms displayed in other wave sectors may be changed for the current patient through the display menu. See “Display Menus” on page 19.

Parameter Blocks

Measurements for displayed waveforms and monitored parameters are provided in the parameter blocks. Parameter Block 1 always contains the heart rate and HR alarm settings. The NBP schedule, measurements, and alarm settings are also displayed in Parameter Block 1. Parameter Block 2 contains measurements and alarm settings for SpO measurement is labeled and displays the current value and the high and low alarm limit settings or the

(alarms off) icon. A “-?-” is displayed until a valid measurement can be obtained.

, Pulse, EtCO2 and Airway Respiration Rate (AwRR). Each

and EtCO2 measurements are activated when the associated parameter cable/tubing is

SpO

connected. When the SpO and requests approval to turn off the measurement.

Parameter Alarm Messages are displayed in the space above each numeric value, replacing the parameter label.

Soft Key Labels

The four soft key labels correspond to the soft key buttons located immediately below. These labels change, as appropriate, according to the current display view and function. Soft key labels appearing as grey text indicate that the soft key is inactive.

and EtCO2 cable/tubing is disconnected, a prompt message informs you

Display Views 2 Getting Acquainted

Display Menus

Menus with controls and options specific to each function of the HeartStart MRx are easily accessible through the Menu Select and Navigation buttons located on the front panel. Menus are used to adjust volume, select waveforms for display, set alarms, schedule measurements, enter patient information, perform the Operational Check, generate reports, and a variety of other tasks. Menus and submenus are organized to allow you to conveniently make selections and enter information.

To display a menu, press the Menu Select button. Then use the up or down Navigation buttons to scroll through the available choices until the desired selection is highlighted. To activate the selection, press the Menu Select button. Press Exit to close the menu without activating a selection.

Figure 8 Sample Menu

HR/Arrhythmia

Relearn Rhythm

Alarms Off

HR Limits

VTACH Limits

Message Windows

Periodically, message windows appear on the display to provide additional status information, alert you to an error or a potential problem, or direct you to take action. Remain alert to these messages. If a response is required, as shown in Figure 9, use the Navigation and Menu buttons to highlight and select the appropriate answer.

Figure 9 Sample Message Window

Exit

Configuration Not Saved - Exit Anyway?

Yes

2 Getting Acquainted Controls

High Contrast Display

To optimize visibility of the MRx display when used in bright sunlight, Version A.02 and later devices provide a High Contrast feature which may be enabled. In this view, the MRx display appears using a yellow background with all other screen elements appearing in black or shades of gray. High Contrast is enabled in Manual Defib, Pacer and Monitor Modes by pressing the Menu Select button and selecting High Contrast On from the Main Menu.

NOTE The High Contrast feature does not display colors configured as red or blue, therefore, be sure your

device is configured correctly with the appropriate parameter color settings. See Table 16 on page 132 in Configuration.

Controls

The Therapy Knob is used to turn the HeartStart MRx on in the desired mode of operation. Operating controls are organized by function, with general function buttons located along the left and bottom sides of the display, defibrillation controls to the right of the display, and soft keys immediately below the display. (See Figure 1.)

Therapy Knob

The Therapy Knob serves as the power switch for the HeartStart MRx. It can be set to:

•Off

• AED - to enable AED Mode for automated external defibrillation.

• Monitor - to enable Monitor Mode for 3- or 5-lead ECG monitoring, 12-lead ECG acquisition, or

monitoring of optional parameters such as SpO2, CO2, and NBP.

• Pacer - to enable Pacer Mode (optional) for demand or fixed mode pacing.

• Manual Defib - to enable Manual Defib Mode for asynchronous or synchronous defibrillation

(cardioversion) at the selected energy setting.

In Manual Defib Mode the defibrillation energy settings are labeled as 1-9, 10, 15, 20, 30, 50, 70, 100, 120, 150, 170, and 200 Joules. If your unit is equipped with the optional pacing function, the energy settings are labeled as 1-10, 15, 20, 30, 50, 70, 100, 120, 150, 170, and 200 Joules.

Controls 2 Getting Acquainted

General Function Buttons

The general function buttons control monitoring or non-critical resuscitation activities. They include:

Mark Event button - allows you to insert a time-stamped annotation in the Event Summary Report to note events as they occur, including the administration of certain drugs. A Mark Event button label appears at the top left corner of the display.

Lead Select button - changes the ECG lead in Wave Sector 1. Pressing this button cycles through the available ECG waves, changing the displayed wave and label. The list of available ECG waves is based on the current lead set and device configuration, and includes pads or paddles, if the corresponding cable is connected to the device.

Alarm Pause button - The Alarm Pause button pauses all visual and audible physiological alarms and audible inops for the configured time interval. At the end of the pause interval, each alarm returns to its previous setting (On or Off). Pressing the Alarm Pause button during the pause interval also returns alarms to their previous settings.

Print button - The Print button initiates a continuous print-out of the primary ECG and the waveform displayed in Wave Sector 2, either real-time or with a 10-second delay, depending on your configuration.

Event Summary button - The Event Summary button prints the current or most recent Event Summary report.

Menu Select button - Pressing the Menu Select button either brings up the current menu or confirms a menu selection.

Navigation buttons - The Navigation buttons display the current menu just as the Menu Select button does. Additionally, within any menu or list, these buttons move to the next or previous item in the list. They also increase or decrease numbers or values in a sequence. They may be held down to accelerate through the available choices.

2 Getting Acquainted Controls

Defibrillation Controls

The defibrillation controls are shown in Figure 10. They include the:

Therapy Knob - Enables AED or selects an energy for Manual Defib Mode defibrillation or cardioversion.

Charge Button - Charges the defibrillator to the selected Manual Defib energy setting. Used only in Manual Defib Mode. In AED Mode, the defibrillator charges automatically.

Shock Button - Delivers a shock through multifunction electrode pads or switchless internal paddles. In AED mode a 150J shock is delivered. In Manual Defib Mode, the shock is delivered at the selected Manual Defib energy setting.

NOTE When external paddles or switched internal paddles are used, once the HeartStart MRx is fully

charged, the shock is delivered by pressing the Shock button(s) on the paddles.

Sync Button - Toggles between synchronized energy delivery used during cardioversion and asynchronous energy delivery used during defibrillation.

Figure 10 Defibrillation Controls

Soft Keys

Sync Button

Therapy Knob

100

1-10

acer

onitor

dult

ose

120

150

170

200

elect

nergy

harge

AED

hock

Charge Button

Shock Button

The soft keys perform the function displayed as a label appearing immediately above on the display. The labels (and, therefore, the function) change appropriately for the various modes of operation and are described in the chapters which follow.

Controls 2 Getting Acquainted

Indicators

The HeartStart MRx indicators provide a visual display of device status.

Ready For Use Indicator The Ready For Use (RFU) indicator is located on the upper, right corner of the device. It indicates the status of the therapy delivery functions of the monitor/defibrillator using the following definitions:

• A blinking black hourglass symbol indicates the shock, pacing, and ECG functions of the device are ready for use. Sufficient battery power is available for device operation. Additionally, a blinking black hourglass, together with the presence of external power (AC or DC), indicates that installed battery(s) are being charged.

• A blinking red “X” and a periodic audio chirp indicate no battery is present or a low battery condition. The device can be used, but its operation time is limited. If a battery is inserted and charging, the audio chirp is not present.

• A solid red “X” and a periodic audio chirp indicate a failure has been detected that may prevent the delivery of defibrillation therapy, pacing, or ECG acquisition. When turned on, the device displays inop messages for the failures detected.

• A solid red “X” without periodic audio chirps indicates either there is no power available, or the device cannot power on. If, after power is supplied, the indicator reverts to the blinking black hourglass symbol, the device is once again ready for use.

NOTE The RFU indicator may briefly display a solid red "X" when initially turning the device on, when

switching between clinical and non-clinical operating modes, and at the start of any automated test.

External Power Indicator The external power indicator is located above the display. It is green if power is being provided by an external AC or DC power source. See Figure 11.

Figure 11 External Power Indicator

NOTE The external power indicator will momentarily go out when charging for defibrillation with a charged

battery installed. This is normal operation, as the device is switching its power source to the battery for a faster charge time.

2 Getting Acquainted Responding to Alarms

Responding to Alarms

When an alarm condition occurs and an alarm is indicated, visually and audibly, there are several ways to respond. Initially:

1 Attend to the patient.

2 Identify the alarm(s) indicated.

3 Silence the alarm(s). When an alarm is announced, the audio pause label (see Figure12) is

presented above the Navigation and Menu Select buttons. Pressing any of these buttons will silence the alarm audio while you are attending to the patient.

Figure 12 Audio Pause Label

AUDIO PAUSE

For devices with serial numbers US001XXXXX

Then:

4 Address the alarm condition on the HeartStart MRx. The menu shown in Figure 13 appears.

Figure 13 Sample Alarm Response Menu

AUDIO PAUSE

For devices with serial numbers US002XXXXX

SpO2 Alarm

Alarms Off

Acknowledge

New Limits

Alarms Off Turns the monitoring parameter’s alarms off. The alarm message is no longer displayed, and the icon appears next to the parameter value.

Acknowledge The alarm message continues to display and, if after 2 minutes the alarm condition still exists, the alarm audio and response sequence occurs again.

New Limits Adjust the parameter limits accordingly.

WARNING Although the Alarm Pause button can be used when responding to alarms, the response procedures

described above are recommended.

NOTE The information above does not pertain to Heart Rate or Arrhythmia Alarms. For information about

responding to these alarms, see “Responding to HR and Arrhythmia Alarms” on page 52.

Entering Patient Information 2 Getting Acquainted

Entering Patient Information

Patient information may be entered for the following:

•Name

•ID

• Patient Category

•Age

•Sex

•Paced

Information is entered using the Patient Info menu. Patient Name is entered using 2 alphabetical lists, one to enter the last name, followed by another to enter the first name. When each name is complete, select Done or Cancel to close the patient name menu without saving.

Continued Use

Once a patient event is started, the Continued Use feature is activated. This feature facilitates continued treatment of the same patient by retaining the current settings and the patient record when the HeartStart MRx is turned off for less than 10 seconds, for instance when switching between AED and Manual Defib Modes or when the Therapy Knob is inadvertently moved to Off. When turned on within the 10 second time period, the HeartStart MRx retains the most recent settings, including:

• Alarm settings

• Wave Sector settings

•Event Timer

• QRS, alarm tone, and voice prompt volumes

•ECG gain

• Pacing settings

• Patient record in the Event Summary Report; new data is appended to the record.

The Sync feature remains active if the HeartStart MRx is turned off for less than 10 seconds. However, Sync is disabled when AED Mode is activated, and must be turned on upon returning to Manual Defib Mode.

NOTE The Continued Use feature will not function if all sources of power (battery and external AC/DC

power modules) are removed from the device, even briefly.

2 Getting Acquainted Return to Owner

Return to Owner

The Return to Owner feature is available in Version A.02 and later devices and allows the owner of the HeartStart MRx to enable a specified loan period, after which the borrower of the MRx will be reminded to return the device to its owner as identified on the display. The feature is password protected in Configuration and enabled through the Other Menu, where the owner can activate, deactivate, and specify the length of the loan period.

NOTE Monitoring and defibrillation functions are suspended while the Return to Owner set-up screen is

displayed.

NOTE The appearance of the loan expiration message does not disable monitoring and defibrillation

functionality.

To enable the Return to Owner feature:

1 Press the Menu Select button.

2 Select Other from the menu and press the Menu Select button.

3 Select Return To Owner and press the Menu Select button.

4 Press the [Activate] soft key.

5 Enter the number of days in the loan period and press the Menu Select button.

6 Press the [Exit Return-To] soft key.

To disable the Return to Owner feature:

1 Press the Menu Select button.

2 Select Other from. the menu and press the Menu Select button.

3 Select Return To Owner and press the Menu Select button.

4 Press the [Deactivate] soft key.

5 Enter the password and press the Menu Select button.

6 Press the [Exit Return-To] soft key.

3Setting Up

This chapter provides the basic set-up information you need to prepare your device for operation and to connect the optional monitoring accessories to your HeartStart MRx.

NOTE If your HeartStart MRx does not have optional SpO

functionality, or optional accessory pouches, disregard these features and the related information described in this chapter.

Before using the HeartStart MRx, review the configuration settings of your device. Confirm and update the settings as appropriate.

, CO2, NBP, Pacing, or 12-lead ECG

Attaching the Carrying Case and Accessory Pouches

The HeartStart MRx accessory pouches are designed to hold your essential monitoring and defibrillation accessories. Follow the procedures below for assembly and recommended accessory placement.

1 Disconnect all external power and remove all batteries.

2 Lower the device into the sleeve of the carry case. The rear base of the device fits in the sleeve

socket.

Paddle Tray

a. If paddles are connected, disconnect them from the Therapy port and remove them from the

paddle tray.

b. Remove the 4 T-15 screws from the tray plates.

c. Gently lift the paddle tray up, leaving all wires connected.

Handle Only

a. Remove the handle cover by pushing in on either side of the handle cover and lifting up.

b. Remove the 2 T-15 screws.

c. Remove the handle.

d. Gently lift the cap plate up.

3 Setting Up Attaching the Carrying Case and Accessory Pouches

Fold the two sleeve flaps over the top of the device, positioning them so that the screw holes are exposed.

4 Replace the paddle tray or cap plate, as appropriate, so that the molded openings fit over the sleeve

flaps.

5 Secure the front and rear cinch straps using the metal rings provided.

6 Perform an Operational Check as described in, “Maintenance” on page 151.

7 Attach the side pouches using the snaps located inside the pouch pockets.

Figure 14 Accessory Pouch Assembly and Accessory Placement

Storing Accessories 3Setting Up

(

(((

(

(((

(

(((

(

Storing Accessories

1 Store parameter cabling and accessories as shown below.

2 Route the ECG cabling underneath the paper storage cylinder.

3 Setting Up Storing Accessories

(

((

(

((

(

3 Attach the Therapy cable and route it through cable fastener loop, securing the cable just below the

strain relief.

4 Attach the rear pouch using the buckles provided.

NOTE Depressions are provided on the inside of the rear pouch should you wish to make a cut-out to

accommodate external power.

(

WARNING When using the carry bag to transport the HeartStart MRx, it is important to position it with the

display facing away from the body. If not, the Therapy Knob may be bumped and inadvertently moved from its current position.

Connecting the ECG Cable 3Setting Up

Connecting the ECG Cable

To connect a 3-, 5- or 10-lead cable:

1 Align the ECG cable with the white ECG port, as shown in Figure 15. The white key marker on

the ECG cable faces the top of the device.

2 Push the ECG cable firmly into the ECG port, until the white portion of the cable connector is no

longer visible.

Figure 15 Connecting the ECG Patient Cable

ECG

3 Setting Up Connecting the SpO2 Cable

Connecting the SpO2 Cable

To connect the SpO2 cable:

1 Hold the cable connector with the flat side facing front, as shown in Figure 16.

2 Insert the cable into the blue SpO

the cable connector is no longer visible.

Figure 16 Connecting the SpO

port on the HeartStart MRx and push until the blue portion of

Cable

Connecting the NBP Interconnect Tubing 3Setting Up

Connecting the NBP Interconnect Tubing

To connect the NBP Interconnect Tubing:

1 Insert the NBP Interconnect Tubing into the red NBP port as shown in Figure 17.

2 Attach the NBP Interconnect Tubing fitting to the NBP cuff.

Figure 17 Connecting NBP Interconnect Tubing / NBP Cuff

ECG

3 Setting Up Connecting the CO2 Nasal FilterLine

Connecting the CO2 Nasal FilterLine

To connect the CO2 Nasal FilterLine®:

1 Using the end of the nasal FilterLine fitting, slide the CO

2 Insert the fitting into the CO

Inlet port as shown in Figure 18.

3 Turn the fitting clockwise into place.

Figure 18 Connecting the CO

Nasal FilterLine

ECG

compartment door down.

Connecting the Therapy Cable 3Setting Up

Connecting the Therapy Cable

To connect the Therapy cable:

1 Align the white pointer on the cable with the white arrow on the green Therapy port as shown in

Figure 19.

2 Insert the cable into the green Therapy port. Push until you hear it click into place.

Figure 19 Connecting the Therapy Cable

3 Setting Up Installing Paper

Installing Paper

50mm Printer

To install printer paper:

1 Open the printer door by pushing on the latch as shown in Figure 20.

2 If there is an empty or low paper roll in the printer, pull up on the roll to remove it.

3 Place a new roll of printer paper into the paper well, positioning the roll so that the end of the roll

is on the bottom and the grid faces up.

4 Pull the end of the paper out past the paper roller.

5 Close the printer door.

Figure 20 Installing Paper(50mm)

onitor

Installing Paper 3Setting Up

Shock

AED

Monitor

Off

Shock

AED

Monitor

Off

75mm Printer

To install printer paper:

1 Open the printer door by pushing on the latch as shown in Figure 21.

2 If there is an empty or low paper roll in the printer, pull up on the tab holding the paper roll to

remove it.

3 Place a new roll of printer paper into the paper well, positioning the roll as shown in Figure 21.

4 Pull the end of the paper out past the paper roller.

5 Close the printer door.

Figure 21 Installing Paper (75mm)

3 Setting Up Installing Batteries

Installing Batteries

To install the batteries:

1 Align the M3538A Lithium Ion battery in a battery compartment.

2 Insert the battery, and press until you hear it click into place. Ensure that the latches located on

both sides of the battery are engaged fully.

Figure 22 Installing batteries

Charging Batteries

Charge batteries fully upon receipt and prior to use. Be sure to familiarize yourself with the battery maintenance procedures discussed in “Maintenance” on page 151.

Battery Safety

Review the Application Note, M3538A Lithium Ion Battery - Characteristics and Care, provided with your HeartStart MRx. Additionally, read the battery related warnings in “Specifications and Safety” on page 213, prior to using the M3538A Lithium Ion Battery.

Installing the AC Power Module 3Setting Up

Installing the AC Power Module

If not presently installed in your device, insert the M3539A AC power module as follows:

1 Align the M3539A AC power module in Compartment B.

2 Insert the AC power module, and press until you hear it click into place. Ensure that the latched

located on both sides of the AC power module are engaged fully.

3 Insert the power cord into the AC power receptacle.

4 Plug into an AC power outlet.

5 Check that the External Power indicator on the front panel is illuminated.

Figure 23 Installing the AC Power Module

3 Setting Up Installing the Data Card

Installing the Data Card

If not presently installed in your device, install the data card as follows:

1 Insert the data card in the data card tray, sliding it under the tray clip.

2 With the front of the tray facing forward, insert the tray fully into the data card slot located on the

right side of the HeartStart MRx.

Figure 24 Installing the Data Card/Tray

nergy

harge

CAUTION Even if a data card is not used, the data card tray should always be installed to protect the device from

the ingress of liquids or solids.

This chapter describes the basic ECG and arrhythmia monitoring functions of the HeartStart MRx monitor/defibrillator. For specific information related to taking a 12-Lead ECG, refer to Chapter 11, “12-Lead ECG” on page 105.

Overview

The HeartStart MRx can be used for ECG and arrhythmia monitoring. The monitoring function allows you to monitor through:

• multifunction electrode pads, or

4ECG and Arrhythmia

Monitoring

• 3-, 5-, or 10-lead ECG sets.

If both pads and monitoring electrodes are connected, monitoring allows you to select a lead from the 3-, 5- or 10-lead ECG source, or to monitor through the pads.

Configurable heart rate and arrhythmia alarms clearly communicate patient status, both audibly and visually.

4 ECG and Arrhythmia Monitoring Monitoring View

Monitoring View

Monitoring View appears on the display when the Therapy Knob is in the Monitor position. Figure 25 shows the information displayed in Monitoring View.

Figure 25 Monitoring View

Monitoring View can display up to four ECG waves. Numeric values for heart rate and all other available parameters are displayed, as well as any active alarm settings.

Preparing to Monitor ECG 4 ECG and Arrhythmia Monitoring

There are two separate sources of ECG, the ECG leads connection and the Pads/Paddles connection. Leads/pads are displayed according to your device’s configuration. Typically, Lead II is configured as the primary ECG lead source, displayed in Wave Sector 1. You may change this during use with the Lead Select button. You can also configure the HeartStart MRx to display up to 3 additional leads (or pads/paddles) when turned on (see Chapter 13, “Configuration” on page 125). The leads displayed may be changed during use through the Waves menu item.

Monitoring View displays the first valid source of ECG acquired in Wave Sector 1. For example, if your HeartStart MRx has Lead II configured to display in Wave Sector 1, but pads are attached to the patient and connected to the defibrillator before a valid ECG can be obtained from the monitoring electrodes, then Pads will be displayed in Wave Sector 1. However, Lead II will take its place as soon as it is acquired.

NOTE The ECG lead source appearing in Wave Sector 1 is used to determine heart rate and monitor

arrhythmia.

Preparing to Monitor ECG

To prepare for monitoring ECG, perform the following steps.

If monitoring via electrodes:

1 Prepare the patient’s skin prior to applying monitoring electrodes. Skin is a poor conductor of

electricity, so skin preparation is important in achieving good electrode-to-skin contact. – Identify the appropriate electrode sites (See Figures 27 and 28.)

– If necessary, clip hair at the electrode sites (or shave sites if needed).

– Wash sites thoroughly with soap and water. (Never use ether or pure alcohol, as this increases

skin resistance.)

– Dry the electrode sites briskly to increase capillary blood flow in the tissues and to remove oil

and skin cells.

2 Attach the snaps to the electrodes before placing them on the patient.

3 Apply the electrodes by peeling them, one at a time, from the protective backing and sticking them

firmly to the patient’s skin. Refer to Figures 27 and 28 for proper electrode placement. Press around the entire edge of each electrode to ensure they are secure. Make sure the lead wires do not pull on the electrodes.

WARNING Be sure that the electrodes do not come in contact with other conductive materials, especially when

connecting or disconnecting the electrodes to/from the patient.

4 ECG and Arrhythmia Monitoring Preparing to Monitor ECG

If not preconnected, connect the ECG patient cable.

– Align the keyed patient cable connector with the ECG port on the Measurement module, as

shown in Figure 26.

– Push the patient cable firmly into the ECG port until the white portion is no longer visible.

Figure 26 ECG Cable Connection

ECG

If monitoring via multifunction electrode pads:

1 If not preconnected, connect the pads cable to the HeartStart MRx. See Figure 34 on page 57.

2 Connect the pads to the pads cable. See Figure 35 on page 58.

3 Apply the pads as directed on the package.

NOTE If monitoring for extended periods of time, monitoring electrodes and multifunction electrode pads

may need to be changed periodically. Refer to the manufacturer’s documentation for how often to replace the monitoring electrodes or pads.

Electrode Placement 4 ECG and Arrhythmia Monitoring

Electrode Placement

Figure 27 shows the typical electrode placement for a 3-lead ECG set.

Figure 27 3-lead Placement

RA/R placement: directly below the clavicle and

RA/R (White/ Red)

–

LA/L

–

(Black/ Yellow)

near the right shoulder

LA/L placement: directly below the clavicle and near the left shoulder

III

LL/F placement: on the left lower abdomen

LL/F

(Red/

Green)

Figure 28 shows the typical electrode placement for a 5-lead ECG set.

Figure 28 5-lead Placement

RA/R placement:directly below the clavicle and near

the right shoulder

LA/L placement: directly below the clavicle and near the left shoulder

RL/N placement: on the right lower abdomen

RA/R

–

(White/ Red)

V/C (Brown/ White)

aVL

–

LA/L (Black/ Yellow)

–

aVR

III

aVF

LL/F placement: on the left lower abdomen

RL/N (Green/ Black)

LL/F

(Red/ Green)

V/C placement: on the chest; the position depends on your required lead selection. See Figure 29.

4 ECG and Arrhythmia Monitoring Electrode Placement

The V/C lead may be placed in any of the precordial lead positions as shown in Figure 29 (V1/C1 through V6/C6).

Figure 29 V/C Electrode Placement

V1/C1 placement:fourth intercostal space at

right sternal margin.

V2/C2 placement: fourth intercostal space at left sternal margin.

V3/C3 placement: midway between V2 and V4.

V4/C4 placement: fifth intercostal space at left midclavicular line.

V5/C5 placement: same level as V4 on anterior axillary line.

V6/C6 placement: same level as V4 at left mid

line.

axillar

For accurate V/C lead placement and measurement, it is important to locate the fourth intercostal space, as follows:

1 Locate the second intercostal space by first palpating the Angle of Lewis (the small bony

protuberance where the body of the sternum joins the manubrium). This rise in the sternum is where the second rib is attached, and the space just below this is the second intercostal space.

2 Palpate and count down the chest until you locate the fourth intercostal space.

Figure 30 shows the typical electrode placement for a 10-lead ECG set.

Figure 30 10-lead Placement

Conventional 12-Lead ECG In conventional 12-Lead ECG using 10 electrodes, an electrode is placed on the right arm, left arm, right leg, and left leg. Six V/C electrodes are placed on the chest as shown in Figure 30. The right leg electrode is the reference electrode.

Lead Selection 4 ECG and Arrhythmia Monitoring

Lead Selection

It is important to select a suitable lead for monitoring so that a QRS complex can be accurately detected. The guidelines for lead selection are as follows:

For non-paced patients:

• QRS complex should be tall and narrow (recommended amplitude > 0.5mV).

• R-wave should be above or below the baseline (but not biphasic).

• P-wave should be smaller than 1/5 R-wave height.

• T-wave should be smaller than 1/3 R-wave height.

NOTE To prevent detection of P-waves or baselines noises as QRS complexes, the minimum detection level

for QRS complexes is set at 0.15 mV, according to AAMI-EC 13 specifications. If the ECG signal is too weak, you may get false alarms for asystole.

For paced patients with internal/transvenous pacemakers, in addition to the above, the pace pulse should be:

• not wider than the normal QRS complex.

• large enough to be detected (half the height of the QRS complex), with no re-polarization artifact.

NOTE Adjusting the ECG wave size on the display does not affect the ECG signal which is used for

arrhythmia analysis.

Lead Choices

Available monitoring leads vary depending upon what type of ECG cable is connected to your HeartStart MRx and its configuration. Table 2 shows the choice of leads available for 3-, 5-, and 10lead ECG sets.

Table 2 Lead Choices

If you are using: These leads are available:

a 3-lead ECG set I, II, III

a 5-lead ECG set I, II, III, aVR, aVL, aVF, V/C

a 10-lead ECG set I, II, III, aVR, aVL, aVF,

V1/C1, V2/C2, V3/C3, V4/C4, V5/C5, V6/C6

4 ECG and Arrhythmia Monitoring Arrhythmia Monitoring

Selecting the Lead

The ECG lead for Wave Sector 1 is selected through the Lead Select button or through the Waves menu. The ECG lead for Wave Sectors 2-4 is selected through the Wa ve s menu, as follows:

1 Press the Menu Select button.

2 Using the Navigation buttons, select the Wav es menu and press the Menu Select button.

3 Select the Wave Sector and press the Menu Select button.

4 Select the desired lead and press the Menu Select button.

5 If needed, use the Navigation buttons to adjust the ECG wave size (gain) and press the Menu

Select button.

Figure 31 Waves Menu

Main Menu

Volume

Waves

Measurements/Alarms

Patient Info

Other

Exit

Waves

Wave 1

Wave 2

Wave 3

Wave 4

Exit

Wave 1

Paddles

III

aVR

aVL

aVF

1/2

1/4

uto

Arrhythmia Monitoring

The HeartStart MRx uses the ST/AR Basic Arrhythmia Algorithm. Arrhythmia analysis provides information on your patient’s condition, including heart rate and arrhythmia alarms. The HeartStart MRx uses the ECG lead appearing in Wave Sector 1 for single-lead arrhythmia analysis.

NOTE Because the ST/AR Basic Arrhythmia Algorithm is the HeartStart MRx’s cardiotach source and is

needed to generate heart rate and heart rate alarms, the algorithm can never be disabled. However, if desired, arrhythmia and heart rate alarms can be turned off.

During arrhythmia analysis, the monitoring function continuously:

• optimizes ECG signal quality to facilitate arrhythmia analysis. The ECG signal is continuously filtered to remove baseline wander, muscle artifact, and signal irregularities. Also, if the Patient Paced status is set to Yes, pace pulses are filtered out to avoid processing them as QRS beats.

• measures signal features such as R-wave height, width and timing.

• creates beat templates and classifies beats to aid in rhythm analysis and alarm detection.

• examines the ECG signal for ventricular fibrillation, asystole, and noise.

Arrhythmia Monitoring 4 ECG and Arrhythmia Monitoring

Aberrantly-Conducted Beats

As P-waves are not analyzed, it is difficult and sometimes impossible for the algorithm to distinguish between an aberrantly-conducted supraventricular beat and a ventricular beat. If the aberrant beat resembles a ventricular beat, it is classified as a ventricular beat. You should always select a lead where the aberrantly-conducted beats have an R-wave that is as narrow as possible to minimize incorrect classifications.

Intermittent Bundle Branch Block

Bundle branch and other fascicular blocks create a challenge for the arrhythmia algorithm. If the QRS complex changes considerably from the learned normal due to a bundle branch block, the blocked beat may be incorrectly identified as ventricular, and may cause false PVC alarms. You should always select a lead where the bundle branch block beats have an R-wave that is as narrow as possible to minimize incorrect classifications.

NOTE For more information on arrhythmia analysis, refer to the Application Note, “Arrhythmia Monitoring

Algorithm” available on the web at www.medical.philips.com/goto/productdocumentation.

4 ECG and Arrhythmia Monitoring Heart Rate and Arrhythmia Alarms

Heart Rate and Arrhythmia Alarms

The HeartStart MRx detects arrhythmia alarm conditions by comparing ECG data to a set of predefined criteria. An alarm can be triggered by a rate exceeding a threshold (for example HR > XX), an abnormal rhythm (for example, Ventricular Tachycardia), or an ectopic event (for example, PVC > limit).

HR/Arrhythmia Alarms can be generated for the conditions shown in Tables 3 and 4. Once generated, they appear as alarm messages in the alarm status area of the display located just above the HR numeric. The notification of an alarm is indicated by both an audible and visual alert signal.

The presence of multiple alarm conditions is quite possible. Announcing all of the detected alarms would cause confusion and a less serious condition might hide a more serious condition. For this reason, alarms are prioritized and categorized so that the most serious or highest priority alarm condition is the one announced.

Arrhythmia Alarm Latching

Arrhythmia Alarms are categorized as “latching” or “non-latching” alarms. Latching alarms are announced and remain present, regardless of whether the alarm condition still exists, until they are either acknowledged or a higher priority alarm condition occurs. Indications for non-latching alarms are automatically removed when their alarm condition no longer exists.

Latching and non-latching alarms are categorized in Tables 3 and 4.

Table 3 HR/Arrhythmia Red Alarms

Alarm Message Condition Indicator Latching/

Asystole No detectable beats for four

seconds in the absence of Vfib

VFIB/VTACH A fibrillatory wave detected

for four seconds

VTACH Consecutive PVCs and HR

exceed defined limits

Extreme Brady 10 bpm below HR Low

limit, capped at 30 bpm

Extreme Tachy 20 bpm above HR High

limit capped at 200 bpm (adult) or 240 bpm (pedi)

Red alarm message, alarm tone

Non-Latching

Latching

Heart Rate and Arrhythmia Alarms 4 ECG and Arrhythmia Monitoring

Table 4 HR/Arrhythmia Yellow Alarms

Alarm Message Condition Indication Latching/

Non-Latching

HR High The HR exceeds the configured

HR high limit

HR Low The HR is below the configured

HR low limit

PVC/min High (value > limit)

Pacer Not Capture No QRS following a pacer pulse Yellow alarm

Pacer Not Pacing No QRS or pacer pulse detected Yellow alarm

NOTE Pacer Alarm Messages are associated with internal/transvenous pacemakers only

The number of detected PVCs in a minute exceeds the limit of 15(adult/pedi.)

Yellow alarm message, alarm tone

message, alarm tone

INOP Messages

INOP messages communicate conditions that prevent the device from monitoring or analyzing the ECG. INOP messages are displayed just above the HR/Arrhythmia alarm status area. If multiple INOP conditions exist, the associated INOP messages will cycle through, alternating every 2 seconds.

Table 5 ECG INOPS

Alarm Message Condition Indication

Non-Latching

Latching

Cannot Analyze ECG Cannot reliably monitor the ECG in

Wave Se c to r 1.

ECG Cable Failure During the Operational Check, a short

has been detected between a lead wire and ground

Leads Off An electrode used for Wave Sector 1

may be off or not attached securely.

Pads /Paddles Off The multifunction electrode pads used

as the source for the Wave Sector 1 may be off or not attached securely.

ECG Unplugged The primary ECG is derived from leads

and the ECG cable is not connected.

ECG Equip Malfunction A malfunction has occurred in the

ECG hardware.

Pads/Paddles Cable Failure

Pads ECG Equip Malfunction

During the Operational Check, a failure was detected in the pads or paddles cable during the pads/paddles ECG test.

A device hardware failure was detected. INOP message, INOP tone

INOP message, INOP tone

4 ECG and Arrhythmia Monitoring Setting Alarms

Setting Alarms

Alarms are automatically enabled in Monitor and Pacer Modes. In Manual Defib mode alarms are automatically enabled if the Sync function is enabled. If the Sync function is not enabled, alarms are enabled in Manual Defib mode using the Alarm Pause button. Alarm settings for Heart Rate (HR) and VTACH are as configured but may be changed during operation for the current patient. The setting for PVC Rate Limit may only be changed in response to a PVC Rate alarm condition. Settings for other HR and arrhythmia alarms may not be changed.

Changing Heart Rate or Vtach Alarm Limits

To change the HR or Vtach Limits:

1 Press the Menu Select button.

2 Using the Navigation buttons, select Measurements/Alarms from the menu and press the Menu

Select button.

3 Select HR/Arrhythmia and press the Menu Select button.

4 Select HR or VTACH Limits and press the Menu Select button.

5 Using the Navigation buttons, select the new values and press the Menu Select button.

Enabling/Disabling Heart Rate and Arrhythmia Alarms

To enable/disable the HR and Arrhythmia Alarms,

1 Press the Menu Select button.

2 Select Measurements/Alarms from the menu and press the Menu Select button.

3 Select HR/Arrhythmia and press the Menu Select button.

4 Select Alarms On/Off and press the Menu Select button.

Responding to HR and Arrhythmia Alarms

When an alarm is announced, the audio pause label is presented above the Navigation and Menu Select buttons. Pressing any of these buttons silences the alarm audio while you are attending to the patient. See Figure 32.

Figure 32 Audio Pause

AUDIO PAUSE

For devices with serial numbers US001XXXXX

Then respond to the alarm condition on the HeartStart MRx. There are two ways to respond to an HR or Arrhythmia alarm:

AUDIO PAUSE

For devices with serial numbers US002XXXXX

1 Acknowledge the alarm condition.

2 Adjust the limits using the New Limits menu.

Displaying an Annotated ECG 4 ECG and Arrhythmia Monitoring

Displaying an Annotated ECG

You may choose to display an annotated ECG with arrhythmia beat labels in Wave Sector 2. The same ECG source appearing in the Wave Sector 1 is displayed with a six second delay along with white arrhythmia beat labels. See Table 6 below for additional information on beat classification.

Table 6 Arrhythmia Beat Labels

Label Description Displayed Location

N Normal Above QRS

V Ventricular Ectopic Above QRS

PPaced Above QRS

' Pacer spike Above the waveform where the pacer spike is

detected. (If the patient is both atrially and ventricularly paced, the display will show two ' marks above the waveform aligned with the atrial and ventricular pacing.)

L Learning Patient’s ECG Above QRS

A Artifact (noisy episode) Above the waveform where the noise is

detected.

? Insufficient information to classify beats Above QRS

I Inoperative condition (e.g. LEAD OFF) Above the waveform at start of INOP, every

second of INOP, and at end of INOP.

M Pause, Missed Beat, No QRS Above the waveform where the condition is

detected.

To display an annotated ECG:

1 Press the Menu Select button.

2 Using the Navigation buttons, Select Wave s and press the Menu Select button.

3 Select Wav e 2 and press the Menu Select button.

4 Select Annotated ECG and press the Menu Select button.

4 ECG and Arrhythmia Monitoring Arrhythmia Learning/Relearning

Arrhythmia Learning/Relearning

When arrhythmia monitoring starts, a “learning” process is initiated. The goal is to learn the patient's normal complexes and/or paced complexes (if the patient with an internal/transvenous pacemaker is in paced rhythm). The learning process involves the first 15 valid (non-noisy) beats encountered during the learning phase.

The family selected to represent the “normal” complex includes the beat that is the most frequently seen, narrowest, on-time beat. For this reason, learning should not be initiated when the patient's rhythm is primarily ventricular.

Arrhythmia learning/relearning automatically occurs when the Therapy Knob is turned to Monitor, Pacer or Manual Defib, any time there is a change in the lead selection for Wave Sector 1, and after the correction of a “Leads or Pads Off” INOP condition that has been active longer than 60 seconds.

Manual relearning should be initiated if the beat detection is not occurring or if beat classification is incorrect and results in a false alarm. Remember, however, that if the same signal condition which caused the algorithm to perform poorly still persists, relearning will not be able to correct the problem. The problem can only be corrected by improving the quality of the signal (e.g., by selecting a different lead.)

To initiate relearning manually,

1 Press the Menu Select button.

2 Using the Navigation buttons, select Measurements/Alarms from the menu and press the Menu

Select button.

3 Select HR/Arrhythmia and press the Menu Select button.

4 Select Relearn Rhythm and press the Menu Select button.

The messages “Learning ECG” and “Learning Rhythm” appear in the rhythm status area of the display.

WARNING If arrhythmia relearning takes place during a ventricular rhythm or during a period of poor ECG signal

quality, ectopic beats may be incorrectly learned as the normal QRS complex. This may result in missed detection of subsequent events of V-tach and high PVC rates.

For this reason, you should:

• take care to initiate arrhythmia relearning only when the ECG signal is noise-free.

• be aware that arrhythmia relearning can happen automatically.

• respond to any INOP messages (for example, if you are prompted to reconnect electrodes).

• always ensure that the arrhythmia algorithm is labeling beats correctly.

Troubleshooting

If your HeartStart MRx does not operate as expected during ECG monitoring, see “Troubleshooting” on page 193.

5Semi-Automated

External Defibrillation

The HeartStart MRx’s Semi-automated External Defibrillation (AED) Mode is designed to guide you through standard treatment algorithms for cardiac arrest. Configuration choices allow you to customize AED Mode to better meet the unique needs of your organization or resuscitation team.

This chapter describes how to use AED Mode. It explains the prompts that guide you through the defibrillation process and describes how prompts vary depending upon the condition of the patient and the configuration of your device.

For information on annotating, storing, and printing event information acquired in AED Mode, see “Data Management” on page 141.

For information on setting configuration choices, see “Configuration” on page 125.

5 Semi-Automated External Defibrillation AED View

AED View

Once the Therapy Knob is moved to AED, AED View is displayed.

Figure 33 AED View Display

Mark Event

Alarms Off

HRHR

8080

PadsPads

02 Mar 2003 10:52

02:42

Shocks: 2Shocks: 2

ANALYZING

DO NOT TOUCH PATIENT

Pause for CPR

Wave Sectors 1 and 2 are combined so that a large ECG may be shown. The Event Timer is also large for easier viewing. A Shock Counter is displayed just below the ECG and shows the total number of shocks delivered to the patient in AED and Manual Defib Mode. Also below the ECG is a prominent text message window which accompanies the voice prompts annunciated in AED Mode.

NOTE Only the ECG acquired through multifunction electrode pads is displayed in AED Mode.

Preparation 5 Semi-Automated External Defibrillation

Preparation

Confirm that the patient is:

•unresponsive

•not breathing

•pulseless

Then:

1 Remove clothing from the patient’s chest. Wipe moisture from the patient’s chest and, if necessary,

clip or shave excessive chest hair.

2 Make sure the multifunction electrode pads packaging is intact and within the expiration date

shown.

3 Apply multifunction electrode pads to the patient as directed on the pads package. Use the

anterior-anterior electrode placement.

4 If not pre-connected, insert the pads cable into the green Therapy port located on the right side of

the device. See Figure 34.

Figure 34 Pads Cable Connection

5 Semi-Automated External Defibrillation Preparation

5 Connect the pads to the pads cable as shown in Figure 35.

Figure 35 Pads Connection

WARNING Do not use anterior-posterior pads placement (multifunction electrode pads placed on the patient’s

chest and back). The AED algorithm used by the HeartStart MRx has not been validated using this placement.

WARNING Do not let the multifunction electrode pads touch each other or other monitoring electrodes, lead

wires, dressings, transdermal patches, etc. Such contact can cause electrical arcing and patient skin burns during defibrillation and may divert defibrillation current away from the heart.

WARNING During defibrillation, air pockets between the skin and multifunction electrode pads can cause patient

skin burns. To help prevent air pockets, make sure defibrillation pads completely adhere to the skin. Do not use dried-out multifunction electrode pads.

CAUTION Aggressive handling of multifunction electrode pads in storage or prior to use can damage the pads.

Discard the pads if they become damaged.

NOTE Impedance is the resistance between the defibrillator’s pads or paddles that the defibrillator must

overcome to deliver an effective discharge of energy. The degree of impedance differs from patient to patient and is affected by several factors including the presence of chest hair, moisture, and lotions or powders on the skin.

The low-energy SMART Biphasic waveform is an impedance-compensating waveform that is designed to be effective across a wide range of patients. However, if you receive a "No Shock Delivered" message, check that the patient’s skin has been washed and dried and that any chest hair has been clipped. If the message persists, change the pads and/or the pads cable.

Using AED Mode 5 Semi-Automated External Defibrillation

Using AED Mode

To operate the HeartStart MRx in AED Mode, follow these three basic steps:

1 Turn the Therapy Knob to AED.

2 Follow the voice and screen prompts.

3 Press the orange Shock button, if prompted.

These steps are described more fully in the sections that follow.

While operating in AED Mode, the capabilities of the device are limited to those essential to the performance of semi-automated external defibrillation. Only the ECG acquired through pads is displayed. Previously set alarms and scheduled measurements are indefinitely paused and entry of patient information is disabled. Additionally, the Sync, Lead Select, and Alarm Pause buttons are inactive.

Step 1 - Turn the Therapy Knob to AED

When the HeartStart MRx is turned on in AED Mode, it checks to see if the pads cable and multifunction electrode pads are properly connected. If the:

• pads cable is not properly attached, you are prompted to "Connect Pads Cable".

• multifunction electrode pads are not connected to the pads cable, pads are not applied to the patient, or pads are not making proper contact with the patient’s skin, you are prompted to "Apply Pads" and "Plug in Connector".

5 Semi-Automated External Defibrillation Using AED Mode

Step 2 - Follow the Screen and Voice Prompts

Once an ECG is detected through the multifunction electrode pads, the HeartStart MRx automatically analyzes the patient’s heart rhythm and warns you not to touch the patient as shown in Figure 36.

Figure 36 ECG Analysis Screen in AED Mode

Shocks: 2Shocks: 2

ANALYZING

DO NOT TOUCH PATIENT

WARNING Handling or transporting the patient during ECG rhythm analysis can cause an incorrect or delayed

diagnosis. Under these circumstances, if the HeartStart MRx issues a "Shock Advised" prompt, keep the patient as still as possible for at least 10 seconds so the HeartStart MRx can reconfirm the rhythm analysis before you deliver a shock.

If artifact interferes with analysis, the message "Analyzing Interrupted, Do Not Touch the Patient" is annunciated while the HeartStart MRx attempts to continue analyzing. If the artifact persists, the message "Cannot Analyze" is annunciated and the message Paused. Attend To Patient is displayed. While paused, analysis is suspended. Check that the pads are making proper contact with the patient’s skin and minimize movement. Analysis resumes automatically after 30 seconds or when you press

[Resume Analyzing].

Adjusting Voice Prompt Volume

You may adjust the volume of the voice prompts at any time by accessing the Voice Volume menu.

Press the Menu Select button.

Select the desired volume level and press the Menu Select button.

Using AED Mode 5 Semi-Automated External Defibrillation

Shock Advised

If a shockable rhythm is detected, the HeartStart MRx automatically charges to 150J. Charging is accompanied by voice and screen prompts as shown in Figure 37. A steady high-pitched tone is sounded, and the orange Shock button flashes when the device is fully charged.

Heart rhythm analysis continues while the HeartStart MRx charges. If a rhythm change is detected before the shock is delivered and a shock is no longer appropriate, the defibrillator is disarmed.

Figure 37 Shock Advised, Charging Display

Shocks: 2Shocks: 2

SHOCK ADVISED

CHARGING

STAND CLEAR

NOTE When the HeartStart MRx is fully charged, you can disarm it any time by turning the Therapy Knob

to the “Off” position or by pressing the [Pause for CPR] soft key. Resume monitoring the patient by turning the Therapy Knob back to AED.

No Shock Advised (NSA)

If a shockable rhythm is not detected, the HeartStart MRx tells you, "No shock advised". If the NSA Action Configuration Choice is set to:

Monitor - the HeartStart MRx monitors the ECG and automatically resumes analysis if a potentially shockable rhythm is detected. You are periodically prompted to "Check airway, check breathing, check circulation. If needed, press Pause and begin CPR." The frequency of these prompts is defined in the Monitor Prompt Interval Configuration Choice. You may press [Pause for CPR] to suspend monitoring and administer CPR. The pause period is defined by the CPR Time Configuration Choice.

Pause Time- analysis is suspended for the specified period, during which time you may administer CPR and attend to the patient. A Pause status bar is displayed as shown in Figure 38. The pause period is defined by the NSA Time Configuration Choice. At the completion of the pause period, the HeartStart MRx resumes analyzing.

Figure 38 Paused Display

PAUSED

ATTEND TO PATIENT

Shocks: 2Shocks: 2

5 Semi-Automated External Defibrillation Using AED Mode

Step 3 - Press the Orange Shock Button, if Prompted

Once charging is complete, the HeartStart MRx prompts you to "Deliver Shock Now; Press the Orange Button Now". Make sure no one is touching the patient or anything connected to the patient. Call out

clearly and loudly, “Stay Clear.” Then press the orange Shock button to deliver a shock to the patient.

WARNING Defibrillation can cause operator or bystander injury. Do not touch the patient or equipment

connected to the patient during defibrillation.

WARNING The Shock button must be pressed to deliver a shock. The HeartStart MRx will not automatically

deliver a shock.

Delivery of the shock is confirmed by the message "Shock Delivered" and the shock counter on the display is updated to reflect the number of shocks given. The defibrillator returns to analyzing the patient’s heart rhythm to see if the shock was successful. Voice and text prompts continue to guide you through additional shocks, if appropriate.

Upon completing the number of shocks in a shock series (as defined in your Shock Series Configuration Choice), the HeartStart MRx pauses for the configured CPR Timer period and you are prompted to "If Needed, Begin CPR". Prompts may be brief or detailed, as defined by the CPR Prompt Configuration Choice. Analysis begins again at the completion of the pause period or when you press

[Resume Analyzing].

If you press [Pause for CPR] after a shock is delivered in the current Shock Series, the length of the CPR Pause is defined by the CPR Timer Configuration Choice.

NOTE You may return to analyzing the patient’s heart rhythm at any time by pressing the [Resume

Analyzing] soft key.

NOTE Once prompted to "Deliver Shock Now; Press the Orange Button Now", if you do not do so within the

configured Auto Disarm time interval, the HeartStart MRx disarms itself and provides a pause for CPR. The device resumes analyzing at the end of the configurable pause period (with a default of 30 seconds) or when the [Resume Analyzing] soft key is pressed.

Troubleshooting 5 Semi-Automated External Defibrillation

Troubleshooting

If your HeartStart MRx does not operate as expected during defibrillation, see “Troubleshooting” on page 193.

6Manual Defibrillation

and Cardioversion

This chapter explains how to prepare for and perform asynchronous and synchronous (cardioversion) defibrillation using multifunction electrode pads, external paddles, and internal paddles.

NOTE Defibrillation is always performed through paddles or pads. However, during defibrillation you may

choose to monitor the ECG using an alternate ECG source (3-, 5-, or 10-lead monitoring electrodes). If an alternate ECG source is connected, any available lead may be displayed.

For information on monitoring optional SpO the corresponding chapter in these Instructions for Use.

, EtCO2, and NBP while in Manual Defib Mode, see

Overview

In Manual Defib Mode, you must assess the ECG, decide if defibrillation or cardioversion is indicated, select the appropriate energy setting, charge the monitor/defibrillator, and deliver the shock. The entire defibrillation process is under your control. Voice prompts are not present. However, text messages on the display provide relevant information throughout the process. It is important to be attentive to these messages when displayed.

The ECG strip and Event Summary are easily annotated with event information using the Mark Event function button. See “Marking Events” on page 148 for more information.

Monitoring alarms are available in Manual Defib Mode, however, they are indefinitely paused once an energy is selected for defibrillation. Alarms may be turned on in Manual Defib Mode by pressing the Alarm Pause button. Alarms are also reactivated once the Therapy Knob is moved to Monitor or Pacer.

When an energy is selected, automatic NBP measurements are discontinued. If a manual NBP measurement is requested by pressing the [Start NBP] soft key, the NBP information, including the current schedule, is displayed in its normal position, and scheduled NBP measurements resume.

NOTE The use of Manual Defib Mode may be password protected in Version A.02 and later devices, as

defined in Configuration. See “Password Security” on page 15.

6 Manual Defibrillation and Cardioversion Code View

Code View

In Manual Defib Mode, an energy is selected and the Code View is displayed. Code View is optimized to clearly communicate data associated with a resuscitation event. Notice the increased prominence of the Event Timer, as well as the enlarged ECG in Wave Sectors 1 and 2 as shown in Figure 39.

Figure 39 Code View Display

Heart Rate

ECG (enlarged)

Mark Event

Alarms Off

HRHR

bpm

8080 02:4202:42

IIII

SpO2SpO2

100

CO2

100

120

bpm

Pulse

000

120

02 Mar 2003 10:52Adult Non-paced

EtCO2

mmHg

50 30

AwRR

Shocks: 2Shocks: 2Selected Energy: 150 JoulesSelected Energy: 150 Joules

rpm

Event Timer (enlarged)

Shock Status Area

Pleth

Start NBP

NOTE The Shock Counter displays the number of shocks delivered while in AED and Manual Defib Modes.

Preparing for Defibrillation 6 Manual Defibrillation and Cardioversion

Preparing for Defibrillation

In preparation for defibrillation:

1 Connect the appropriate Therapy cable.

2 Apply the paddles or pads as described below.

Using Multifunction Electrode Pads

To prepare for defibrillation using multifunction electrode pads:

1 If not pre-connected, connect the pads cable to the HeartStart MRx by aligning the white pointer

on the pads cable connector with the white arrow on the green Therapy port. Then push until you hear it click into place. See Figure 40.

Figure 40 Pads/Internal Paddles Cable Connection

2 Check the expiration date that appears on the pads package.

3 Inspect the packaging for any damage.

4 Connect the pads connector to the pads cable. See Figure 41.

Figure 41 Pads Connector

5 Apply the pads to the patient as directed on the pads packaging or according to your organization’s

protocol.

6 Manual Defibrillation and Cardioversion Preparing for Defibrillation

Using External Paddles

To defibrillate using external paddles:

1 If not pre-connected, connect the paddles cable to the HeartStart MRx by aligning the white

pointer on the paddles cable connector with the white arrow on the green Therapy port. Then push until you hear it click into place. See Figure 42.

Figure 42 Paddles Cable Connection

2 Remove the Paddle Set from the Paddle Tray by pulling the paddles straight up and out of the

paddle tray.

3 Apply conductive matter to the paddle electrodes.

Do not distribute conductive matter by rubbing the paddle electrodes together.

4 Apply paddles to the patient’s bare chest, using the anterior-anterior placement (or in accordance

with your organization’s protocol).

The sternum paddle contains a patient contact indicator (PCI). See Figure 43. If necessary, as indicated by the appearance of either a red or orange LED on the PCI, adjust paddle pressure and placement to optimize patient contact. Once proper contact is made, the PCI shows a green LED.

Figure 43 Patient Contact Indicator

Patient Contact Indicator (PCI)

NOTE Reasonable effort should be made to obtain a reading of at least one green LED. Due to impedance,

this may not be possible for some patients, and orange LEDs may be the best that can be achieved.

Preparing for Defibrillation 6 Manual Defibrillation and Cardioversion

Using Pediatric Paddles

The HeartStart MRx’s external paddle set comes with pediatric paddles included. To use the pediatric paddles set:

1 Depress the latch at the front of the external paddle set while pulling forward on the adult paddle

electrode.

2 Store the adult paddle electrodes in the paddle tray pockets.

3 To defibrillate, see “Using External Paddles” on page 68.

NOTE Impedance is the resistance between the defibrillator’s pads or paddles that the defibrillator must

The low-energy SMART Biphasic waveform is an impedance-compensating waveform that is designed to be effective across a wide range of patients. However, if you receive a “No Shock Delivered” message, check that the patient’s skin has been washed and dried and that any chest hair has been clipped. If the message persists, change the pads and/or the pads cable.

Using Internal Paddles

To defibrillate using internal paddles:

1 Select the appropriate paddle electrode size.

2 If using switchless internal paddles, connect the paddles to the M4740A Paddle Adapter Cable.

3 Connect the paddles cable (or the paddle adapter cable) to the HeartStart MRx by aligning the

pointer on the paddles cable (or paddle adapter cable) with the white arrow on the green Therapy port. Then push until you hear it click into place. See Figure 40.

6 Manual Defibrillation and Cardioversion Defibrillating (asynchronously)

Defibrillating (asynchronously)

Once you have performed the necessary preparation for defibrillation, perform the following steps:

1 Select Energy - To select the energy setting, rotate the Therapy Knob to the desired energy level as

shown in Figure 44. Energy choices range from 1 to 200, with 150J the recommended level for adult patients.

Figure 44 Energy Selection

1-10

acer

onitor

100

dult

ose

120

150

170

200

elect

nergy

harge

hock

AED

Selecting the 1-10 (1-9) energy setting displays the Select Energy menu, with a default setting of 6J. The low energy setting can be changed using the Navigation buttons to increase or decrease the desired setting. Complete your selection by pressing the Menu Select button. Your current energy selection is shown in the Shock Status area of the display as shown in Figure 39.

WARNING Clinicians must select an appropriate energy level for defibrillation of pediatric patients.

WARNING The HeartStart MRx has a built-in limitation of 50 Joules when using internal paddles.

Defibrillating (asynchronously) 6 Manual Defibrillation and Cardioversion

2 Charge - Press the Charge button on the front panel. If using external paddles, the charge

harge

button on the paddles may be used instead. As the defibrillator charges, the energy selection shown in the Shock Status area changes to show the current charge energy. A continuous, low-pitch charging tone sounds until the desired energy level is reached, at which point you will hear a continuous, high-pitch charge done tone.

You may increase or decrease the selected energy at any time during charging or after charging is complete. Simply move the Therapy Knob to the desired energy level as explained above. The defibrillator charges to the selected energy level automatically.

To disarm the defibrillator, press [

Disarm]. If the Shock button has not been pressed within the

time period specified in the Time to Auto Disarm Configuration setting, the defibrillator disarms automatically.

3 Shock - Confirm that a shock is still indicated and that the defibrillator has charged to the selected

energy level. Make sure no one is touching the patient or anything connected to the patient. Call out loudly and clearly, “Stay Clear!”

If using:

– pads or switchless internal paddles, press the flashing Shock button to deliver a shock to

the patient.

– external paddles, simultaneously press the shock buttons located on the paddles to deliver a

shock to the patient.

– switched internal paddles, press the Shock button located on the paddles to deliver a shock to

the patient.

The number of shocks delivered is displayed in the Shock Status area of the display. This number includes any shocks administered while in AED Mode.

WARNING Defibrillation current can cause operator or bystander injury. Do not touch the patient, or equipment

connected to the patient, during defibrillation.

CAUTION Alarms are turned off when an energy is selected for asynchronous defibrillation, and the “Alarms Off”

message is displayed. Alarms remain paused until toggled on using the Alarm Pause button, the Sync function is enabled, or the Therapy Knob is moved to Monitor or Pacer.

6 Manual Defibrillation and Cardioversion Performing Synchronized Cardioversion

Performing Synchronized Cardioversion

Synchronized Cardioversion allows you to synchronize delivery of the defibrillator shock with the R-wave of the ECG being monitored in Wave Sector 1. You may choose to perform synchronized cardioversion through either:

• multifunction electrode pads, or

• external paddles

When using paddles, you should monitor the ECG through monitoring electrodes connected to a 3-, 5- or 10-lead ECG cable or a Philips bedside monitor. You may choose to monitor through an alternate source when using pads, as well. Cardioversion is still delivered through either pads or paddles.

Preparing for Synchronized Cardioversion

In preparation for synchronized cardioversion:

1 Perform the tasks as described in “Preparing for Defibrillation” on page 67

2 If monitoring through a 3-, 5-, or 10-lead ECG cable, plug the ECG cable into the ECG port on

the HeartStart MRx and apply monitoring electrodes to the patient.(See “ECG and Arrhythmia Monitoring” on page 41.)

3 Use the Lead Select button to select pads, paddles or a lead from attached monitoring

electrodes. The selected ECG source should have a clear signal and a large QRS complex. (See “Lead Selection” on page 47.)

NOTE When the patient is already connected to Philips bedside monitoring equipment, an external ‘Sync’

cable plugs into the ECG Output jack of the bedside monitor and connects to the ECG port of the HeartStart MRx. This connects the ECG signal from the monitor into the HeartStart MRx, where it is displayed and synchronization occurs.

The signal from the bedside monitor is displayed as Lead II on the HeartStart MRx, even though it is not necessarily Lead II coming from the bedside monitor.

WARNING • If you use an external monitor as the ECG source, a biomedical technician MUST verify that the

external monitor and the HeartStart MRx combination will deliver a synchronized shock within 60 ms of the peak of the R-wave. Use a 1 mV QRS complex with a QRS width of 40 ms. This performance cannot be guaranteed with all commercially available monitors.

• When monitoring through paddles only, artifact introduced by paddle movement may resemble an R-wave and trigger a defibrillation shock.

Performing Synchronized Cardioversion 6 Manual Defibrillation and Cardioversion

Delivering a Synchronized Shock

To perform synchronized cardioversion:

1 With the Therapy Knob in the Monitor position, press the Sync button located beside the

Therapy Knob to activate the Sync function. A Sync message appears in the upper right corner of Wave S ec to r 1.

2 Confirm that the Sync marker appears with each R-wave.

3 Turn the Therapy Knob to the desired energy level setting.

4 Press the Charge button on the HeartStart MRx or, if using paddles, the yellow charge

harge

button located on the handle of the Apex paddle. Wait until the charge has reached the energy level selected, and you hear a continuous charge done tone.

To disarm the defibrillator, press [

Disarm]. If Shock has not been pressed within the time period

specified in the Time to Auto Disarm Configuration Choice, the defibrillator disarms automatically.

If desired, you may increase or decrease the selected energy level after pressing the Charge button by moving the Therapy Knob to the desired setting. The defibrillator charges to the modified energy level automatically. Wait until the current charge reaches the selected energy level before proceeding.

5 Make sure no one is touching the patient or anything connected to the patient. Call out clearly and

loudly, “Stay Clear!”.

6 Press and hold the Shock button on the HeartStart MRx or, if you are using external

paddles, press and hold the orange buttons on both paddles. The shock will be delivered when the next R-wave is detected.

NOTE It is important to continue to hold the Shock button (or the paddle shock buttons) until the

shock is delivered. The defibrillator shocks with the next detected R-wave.

NOTE Should a device INOP occur while performing synchronized cardioversion, the HeartStart MRx will

not charge, or if charged, will disarm automatically.

WARNING Defibrillation current can cause operator or bystander injury. Do not touch the patient or equipment

connected to the patient during defibrillation.

6 Manual Defibrillation and Cardioversion Troubleshooting

Delivering Additional Synchronized Shocks

If additional synchronized shocks are indicated, perform the following steps:

1 Make sure the Sync function is still enabled, as indicated by the presence of the Sync message in

the upper right corner of the Wave Sector 1.

2 Repeat Steps 4-6 under “Delivering a Synchronized Shock”.

The Sync function of the HeartStart MRx can be configured to either be enabled or disabled after each shock is delivered. If configured to remain enabled and the Therapy Knob is moved to either Monitor or Pacer, the Sync function is still enabled. However, should the Therapy Knob be moved to either the Off or AED positions, the Sync function is disabled.

Disabling the Sync Function

To turn off the Sync function of the HeartStart MRx, press the Sync button.

Troubleshooting

If your HeartStart MRx monitor/defibrillator does not operate as expected during defibrillation, see “Troubleshooting” on page 193.

This chapter explains the noninvasive transcutaneous pacing option available with the HeartStart MRx and describes how to perform pacing.

Overview

Noninvasive transcutaneous pacing therapy is used to deliver pace pulses to the heart. Pace pulses are delivered through multifunction electrode pads that are applied to the patient’s bare chest.

While in Pacer Mode, the ECG strip and Event Summary are easily annotated with event information using the Mark Event function button. See “Marking Events” on page 148 for more information.

7Noninvasive Pacing

NOTE For treatment of patients with implantable devices such as permanent pacemakers or cardioverter-

defibrillators, consult a physician and the instructions for use provided by the device’s manufacturer.

NOTE Waveforms, ECG monitoring, measurements, and most alarms remain active and retain their settings

when you transition from Monitor or Manual Defib Mode to Pacer Mode. However, the waveform displayed in Wave Sector 4 is replaced by the pacing status bar.

NOTE The use of Pacer Mode may be password protected in Version A.02 and later devices, as defined in

Configuration. See “Password Security” on page 15.

7Noninvasive Pacing Alarms

Alarms

Arrhythmia alarms for Pacer Not Pacing and Pacer Not Capture are associated with nontranscutaneous pacing, therefore, these alarms are off when the HeartStart MRx is in Pacer Mode. All other red and yellow alarms are active if enabled, and their limits may be changed while in Pacer Mode. Refer to the specific chapter for each measurement for information on changing alarm limits.

While pacing, should a Pads Off condition occur or the pads cable is disconnected, a latching, red alarm is generated and pacing is stopped. The message, Pacing Stopped. [Pads Off] [Pads Cable Off] is displayed in the top line of the pacing status bar. Once the condition is corrected, resume pacing by pressing the [Resume Pacing] soft key.

While pacing in demand mode, should the ECG source for Wave Sector 1 become invalid, e.g. a Leads Off condition or the ECG cable is disconnected, a latching, red alarm is generated and pacing is stopped. The message, Pacing Stopped. Leads Off. is displayed in the top line of the pacing status bar. Once the condition is corrected, resume pacing by pressing the [Resume Pacing] soft key.

When pacing in demand mode using a 3-lead ECG set, if the lead in Wave Sector 1 is changed, a latching, red alarm is generated. The message, Pacing Stopped. Leads Off. is displayed in the top line of the pacing status bar. Resume pacing by pressing the [Resume Pacing] soft key.

NOTE The Pacing Stopped red alarm cannot be disabled.

ECG INOPS, as described in “ECG INOPS” on page 51, are also annunciated while in Pacer Mode.

WARNING Heart rate displays and alarms function during pacing, but they can be unreliable. Observe the patient

closely while pacing. Do not rely on the indicated heart rate or heart rate alarms as a measure of the patient’s perfusion status.

Pacing View 7Noninvasive Pacing

Pacing View

Pacing View appears when the Therapy Knob is set to the Pacer position. Figure 45 shows information displayed in Pacing View.

Figure 45

Mark Event

HRHR

7070

IIII

SpO2

100

CO2

Adult

120120

5050

Pulse

120

02 Mar 2003 10:52

EtCO2 AwRR

50 30

02:42

Pacing Markers

PACING ON BATTERIES

Pacing Status

70 ppm 50 mADemand Mode

Start NBP

Pacing View includes a status block which appears in Wave Sector 4 of the display. The first line of the status block communicates whether pacing is active or paused. If pacing is powered by batteries, this is indicated here as well, if configured. The second line of the status block identifies the Pacer Mode (demand or fixed), pacing rate (ppm), and pacing output (mA).

Soft keys are available for setting pacing status ([Start Pacing], [Pause Pacing], [Resume Pacing]) and adjusting [Pacer Rate], [Pacer Output].

Resume Pacing

Pacin

Pacer Rate

Soft Keys

Pacer Output

Area

7Noninvasive Pacing Demand Mode Versus Fixed Mode

NOTE If pacing is interrupted for any reason, the [Resume Pacing] soft key must be pressed to

continue pacing.

A white pacing marker appears on the ECG waveform in Wave Sector 1 each time a pacer pulse is delivered to the patient. If pacing in demand mode, white R-wave markers also appear on the ECG until capture occurs.

NOTE R-wave markers do not appear on paced beats.

Demand Mode Versus Fixed Mode

The HeartStart MRx can deliver paced pulses in either demand or fixed mode.

•In demand mode, the pacer only delivers paced pulses when the patient’s heart rate is lower than the selected pacing rate.

•In fixed mode, the pacer delivers paced pulses at the selected rate.

WARNING Use demand mode pacing whenever possible. Use fixed mode pacing when motion artifact or other

ECG noise makes R-wave detection unreliable or when monitoring electrodes are not available.

The HeartStart MRx requires a 3-, 5-, or 10-lead ECG cable and monitoring electrodes as the source of the ECG during demand pacing. Pace pulses are delivered through the multifunction electrode pads, however, the pads cannot be used to monitor the ECG and deliver pace pulses simultaneously.

NOTE The ECG derived from pads does not need to be displayed in a wave sector in order to deliver pacing

therapy.

NOTE When using demand mode, pads are not an available choice for display in Wave Sector 1, through

either the Lead Select button or the Waves menu.

Preparing for Pacing 7Noninvasive Pacing

Preparing for Pacing

To prepare for pacing:

1 If not pre-connected, connect the pads cable to the HeartStart MRx by aligning the white pointer

on the pads cable with the white arrow on the green Therapy port. Then push until you hear it click into place. See Figure 46.

Figure 46 Pads Cable Connection

2 Make sure the multifunction electrode pads packaging is intact and within the expiration date

shown.

3 Connect the pads connector to the pads cable. See Figure 47.

Figure 47 Pads Connector

4 Apply the pads to the patient as directed on the pads packaging or according to your organization’s

protocol.

5 If pacing in demand mode, apply monitoring electrodes (see “Electrode Placement” on page 45),

and connect the ECG cable to the HeartStart MRx (see “Connecting the ECG Cable” on page 31).

NOTE If pacing for long periods of time, new monitoring electrodes and multifunction electrode pads should

be applied periodically. Refer to the manufacturer’s documentation for replacement recommendations.

7Noninvasive Pacing Demand Mode Pacing

Demand Mode Pacing

To pace in demand mode:

1 Turn the Therapy Knob to the Pacer position.

The message, Pacing Paused, appears in the status block and indicates that the pacing function is enabled, however, pace pulses are not being delivered. Pacing is enabled in demand mode, with the configured lead displayed in Wave Sector 1. If the configured lead is set to Pads, Lead II or the first available monitoring lead is displayed.

2 Press the Lead Select button to select the best lead with an easily detectable R-wave. (See

“Lead Selection” on page 47).

3 Verify that white R-wave markers appear above or on the ECG waveform. A single marker should

be associated with each R-wave. If the R-wave markers do not appear or do not coincide with the R-wave, select another lead.

4 Press [Pacer Rate] and use the Navigation and Menu Select buttons to select the desired

number of pace pulses per minute. The initial rate is configurable.

5 If needed, adjust the initial pacer output. To do this, press [Pacer Output] and use the

Navigation and Menu Select buttons to select the desired output. The initial output is configurable.

6 Press [Start Pacing]. The message, Pacing, appears.

WARNING Use care when handling the multifunction electrode pads on the patient to avoid shock hazard during

pacing.

7 Verify that white pacing markers appear on the ECG waveform.

8 Press [Pacer Output]. Then use the Navigation and Menu Select buttons to:

a. increase the output until cardiac capture occurs. Capture is indicated by the appearance of a

QRS complex after each pacing marker.

b. decrease the output to the lowest level that still maintains capture.

9 Verify the presence of a peripheral pulse.

NOTE Spontaneous beats may be present which are not associated with the delivery of pace pulses.

Additionally, if the patient’s heart rate is above the pacer rate, pace pulses are not delivered and, therefore, pacing markers do not appear.

To stop delivery of pace pulses, press [Pause Pacing]. Once paused, press [Resume Pacing] to resume delivery of pace pulses.

You may also stop delivery of pace pulses by moving the Therapy Knob off the Pacer position.

WARNING When Pacing in demand mode, the ECG cable must be directly connected from the patient to the

HeartStart MRx.

Fixed Mode Pacing 7Noninvasive Pacing

WARNING If you are using the pacing function with battery power and the Low Battery Alarm is annunciated,

connect the device to external power or insert a fully charged battery.

NOTE Routinely assess the patient’s cardiac output.

NOTE Pacing will not start if there is a problem with the multifunction electrode pads connection or patient

contact. Pace pulses will not be delivered if there is a problem with the ECG monitoring electrodes connections. If either situation occurs, a system message is displayed to alert you that a lead is disconnected or that the pads have a poor connection.

Fixed Mode Pacing

To pace in fixed mode:

1 Turn the Therapy Knob to the Pacer position.

The message, Pacing Paused, appears and indicates that the pacing function is enabled, however, pace pulses are not being delivered. Pacing is enabled in demand mode, with the configured lead displayed in Wave Sector 1. If the configured lead is set to Pads, Lead II or the first available monitoring lead is displayed.

2 Change the pacer mode to fixed mode, using the menu selections shown below in Figure 48

Figure 48 Changing Pacer Modes

Main Menu

Pacer Mode

Volum e

Waves

Measurements/Alarms

Patient Info

Other

Exit

3 Use the Lead Select button to select the desired lead for viewing.

4 Press [Pacer Rate] and use the Navigation and Menu Select buttons to select the desired

number of paced pulses per minute. The initial rate is configurable.

5 If needed, adjust the initial pacer output. To do this, press [Pacer Output] and use the

Navigation and Menu Select buttons to select the desired output. The initial output is configurable.

6 Press [Start Pacing]. The message, Pacing, appears.

Pacer Mode

Demand

Fixed

WARNING Use care when handling the multifunction electrode pads on the patient to avoid shock hazard during

pacing.

7 Verify that white pacing markers appear on the ECG waveform.

7Noninvasive Pacing Defibrillating During Pacing

8 Press [Pacer Output]. Then use the Navigation and Menu Select buttons to:

a. increase the output until cardiac capture occurs. Capture is indicated by the appearance of a

QRS complex after each pace pulse marker.

b. decrease the output to the lowest level that still maintains capture.

9 Verify the presence of a peripheral pulse.

10 To pause or stop pacing:

–Press [Pause Pacing] to stop the delivery of paced pulses to the patient, or

– Move the Therapy Knob off the Pacer position.

Defibrillating During Pacing

Should it be necessary to defibrillate the patient during pacing, refer to the procedure for defibrillating in Manual Defib Mode in Chapter 6, or AED Mode in Chapter 5. Once the Therapy Knob is moved from the Pacer position to a Manual Defib Mode energy setting or AED, pacing is stopped.

To resume pacing after defibrillation, repeat the pacing procedure, as described in “Demand Mode Pacing” on page 80 or “Fixed Mode Pacing” on page 81. When pacing is resumed, pacing settings selected prior to defibrillation (mode, rate, and output) are retained. Be sure to confirm that cardiac capture has been maintained.

CAUTION Pacing must be turned off before defibrillating with a second defibrillator. The HeartStart MRx can be

damaged as a result.

Troubleshooting

If your HeartStart MRx does not operate as expected during pacing, see Chapter 15, “Troubleshooting” on page 193.

Pulse Oximetry (SpO2) monitoring is one of the tools available to assist in assessing a patient’s cardiac and respiratory systems. This chapter explains how pulse oximetry works and describes how to use the HeartStart MRx to monitor SpO

Overview

Pulse oximetry is a noninvasive method of continuously measuring oxygen saturation (SpO2) in arterial blood. The resultant SpO arterial blood which are saturated with oxygen.

8Pulse Oximetry

reading indicates the percentage of hemoglobin molecules in the

WARNING Do not rely solely on SpO

caused by:

• Incorrect sensor application or use.

• Significant levels of dysfunctional hemoglobins (such as carboxyhemoglobin or methemoglobin).

• Injected dyes such as methylene blue, or intravascular dyshemoglobins such as methemoglobin or carboxyhemoglobin.

• Exposure to excessive illumination such as surgical lamps (especially those with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight.

The HeartStart MRx allows you to monitor SpO2 while in Monitor, Manual Defib, and Pacer Modes.

NOTE For more information on SpO

readings; assess the patient at all times. Inaccurate measurements can be

, refer to the Application Note, Philips Pulse Oximetry.

8Pulse Oximetry Understanding Pulse Oximetry

Understanding Pulse Oximetry

A pulse oximetry sensor sends light through patient tissue to a receiver on the other side of the sensor. As Figure 49 shows, light emitting diodes transmit red and infrared light through peripheral areas of the body, such as a finger.

Figure 49 Pulse Oximetry Sensor

Light Emitting Diodes

Photodetecto

A photodetector positioned opposite the light emitting diodes compares light absorption before and after pulsation. The amount of light getting through reflects the blood flow in the arterioles. This measurement of light absorption during pulsation is translated into an oxygen saturation percentage and an SpO

For accurate SpO

• The patient must have perfusion in that extremity.

value is displayed.

measurements, the following conditions must apply:

• The light emitter and the photodetector must be directly opposite each other.

• All of the light from the emitter must pass through the patient’s tissue.

• The sensor site should be free of vibration and excessive motion.

• Power cables should be kept away from the sensor cable and connector.

Selecting a Sensor 8Pulse Oximetry

Selecting a Sensor

Table 7 shows the SpO2 sensors that may be used with the HeartStart MRx.

Tab le 7 Sp O

Sensors

Sensor Ty pe Patient Type Patient Size Sensor Site

M1191A Reusable Adult >50 kg Finger

M1192A Reusable Pediatric

Small Adult

M1193A Reusable Adult >50 kg Thumb

M1194A Reusable Adult

Pediatric

M1195A Reusable Pediatric 4-15 kg Finger

M1131A Disposable Adult/

Pediatric

M1903B Disposable Pediatric 10-50 kg Finger

M1904B Disposable Adult > 30 kg Finger

NOTE M1903B and M1904B sensors are available outside the US only.

CAUTION • Do not use disposable sensors in high humidity environments or in the presence of fluids which may

15-50 kg Finger

>40 kg Ear

> 20 kg Finger

contaminate sensor and electrical connections, causing unreliable or intermittent measurements.

• Do not use disposable sensors on patients who have allergic reactions to the adhesive.

• Do not use the ear transducer on patients with small ear lobes, as incorrect measurements may result.

NOTE To use Nellcor sensors (M1903B, M1904B), you must connect the M1943B Nellcor adapter cable to

the HeartStart MRx.

8Pulse Oximetry Selecting a Sensor

The most important factor when selecting a sensor is the position of the light emitting diodes in relation to the photodetector. When a sensor is applied, the diodes and the photodetector must be opposite each other. Sensors are designed for patients with a specific weight range and for specific sites. Be sure to:

• Select a sensor appropriate for the patient’s weight.

• Select a sensor site with adequate perfusion. Improve perfusion at the site by rubbing or warming the site.

• Avoid application to sites with edematous tissue.

Reusable Sensors may be reused on different patients after they have been cleaned and disinfected (see the manufacturer’s instructions supplied with the sensor).

Disposable Sensors should be used only once and then discarded. They may be relocated to another sensor site on the patient if the first location does not give the desired results. Disposable sensors must not be reused on different patients.

NOTE A 2-meter SpO

extension cable (M1941A) is available for use with the HeartStart MRx.

Applying the Sensor 8Pulse Oximetry

Applying the Sensor

Follow the manufacturer’s directions for applying and using the sensor, making sure to observe any warnings or cautions. For the best results:

• Make sure the sensor is dry.

• If the patient is moving, secure the sensor cable loosely to the patient.

• Make sure the transducer is not too tight. Too much pressure can cause venous pulsation or can impede the blood flow, resulting in low readings.

• Keep power cables away from the sensor cable and connection.

• Avoid placing the sensor in an environment with bright lights. If necessary, cover the sensor with opaque material.

• Avoid placing the sensor on an extremity with an arterial catheter, blood pressure cuff, or intravenous infusion line.

WARNING • Failure to apply the sensor properly may reduce the accuracy of the SpO

• Inspect the sensor application site at least every two hours for changes in skin quality, correct optical alignment, and proper sensor application. If skin quality is compromised, change the sensor site. Change the application site at least every four hours. More frequent checking may be required due to an individual patient’s condition.

•Using an SpO the cable so that no inductive loops are formed. If the sensor does not appear to be operating properly, remove it immediately from the patient.

CAUTION Do not use more than one extension cable (M1941A).

Position the sensor cable and connector away from power cables to avoid electrical interference.

sensor during MR imaging can cause severe burns. Minimize this risk by positioning

measurement.

8Pulse Oximetry Monitoring SpO

Monitoring SpO

To monitor SpO2:

1 Connect the appropriate sensor cable to the to the HeartStart MRx as described in “Connecting

the SpO

2 Apply the sensor to the patient.

3 If the HeartStart MRx is not turned on, turn the Therapy Knob to Monitor.

4 The default patient category is set to adult. If necessary, use the Patient Info menu to access Patient

Category and select the correct patient category setting (adult/pediatric). This is used to optimize the calculation of the SpO

A -?- is displayed in Parameter Block 2 while the oxygen saturation is initially measured and a value is calculated. In a few seconds a value appears, replacing the -?-. As the patient’s oxygen saturation changes, the SpO

If SpO turned off, the symbol is displayed instead of the alarm limits. SpO “Setting SpO

The patient’s pulse rate as derived from pulse oximetry, is also displayed in Parameter Block 2. If pulse rate alarms are turned on, alarm limits are displayed to the right of the pulse rate value. If alarms are turned off, the symbol is displayed instead of the alarm limits. Pulse alarms are off by default. See “Setting Pulse Rate Alarms” on page 91.

Cable” on page 32.

value is updated continuously. See Figure 50.

alarms are turned on, alarm limits are displayed to the right of the SpO2 value. If alarms are

Alarms” on page 90.

and pulse values.

alarms are on by default. See

Figure 50 SpO

SpO

100

and Pulse / Parameter Block 2

110

120

EtCO2

50 30

AwRR

rpm

Monitoring SpO

Pleth Wave

The pleth wave is displayed in the configured Wave Sector (with a default of Wave Sector 4), if available. If the configured Wave Sector is already populated, the pleth wave is displayed in the first available empty Wave Sector. It is drawn at an approximate speed of 25 mm/second. Grid lines are displayed to indicate signal quality.When signal quality is good, the pleth wave is auto scaled to the grid lines. When signal quality is poor, the size of the pleth wave is proportionately decreased.

8Pulse Oximetry

Figure 51 Pleth Wave Size

When the Therapy Knob is moved to an energy setting, the SpO

and Pulse values, as well as the pleth

wave, continue to be displayed. When the Therapy Knob is moved to Pacer, the pacing status bar appears in Wave Sector 4, replacing the waveform in that sector. However, the SpO

and Pulse values

and alarm settings are retained even if the pleth wave is no longer displayed. If the Therapy Knob is moved to AED, SpO

and pulse related information is no longer monitored.

8Pulse Oximetry Setting SpO2 Alarms

Setting SpO

Alarms are annunciated if measurements fall outside the configured limits for high or low SpO2, or if the measurement falls below the configured SpO

Alarms are on unless you turn them off during use. Once disabled, alarms remain off until they are turned on.

WARNING Turning off alarms prevents all alarms associated with the SpO

If an alarm condition occurs, NO alarm indication will be given.

Alarms

Desat Limit.

Changing the SpO2 Alarm Limits

To change the SpO2 Alarm Limits, perform the following steps:

1 Press the Menu Select button.

2 Using the Navigation buttons, select the Measurements/Alarms menu and press the Menu Select

button.

3 Select SpO

4 Select SpO

5 Using the Navigation buttons, select the new high limit value and press the Menu Select button.

and press the Menu Select button.

Limits and press the Menu Select button.

measurement from being annunciated.

6 Select the new low limit value and press the Menu Select button.

SpO2 Desat Alarm

The HeartStart MRx also provides an alarm for SpO2 Desat Limit. The SpO2 Desat alarm provides an additional limit setting below the low limit setting to notify you of potentially life threatening decreases in oxygen saturation. This additional limit setting is preset through the Configuration menu.

NOTE If the SpO

Limit value is automatically adjusted to the SpO below this limit, the SpO

Low Limit alarm value is set below the configured SpO2 Desat Limit, the SpO2 Desat

Desat Limit alarm is announced.

Enabling/Disabling the SpO2 Alarms

To e na bl e th e Sp O2 Alarms, perform the following steps:

1 Press the Menu Select button.

2 Using the Navigation buttons, select the Measurements/Alarms menu and press the Menu Select

button.

3 Select SpO

4 Select Alarms On/Off and press the Menu Select button.

NOTE While an NBP measurement is in progress, SpO

and press the Menu Select button.

Low Limit alarm value. Should the SpO2 reading fall

INOP messages are suppressed for up to 60 seconds.

Philips HeartStart MRx User manual (2005)

Specifications and Main Features

Frequently Asked Questions

User Manual

Overview

1Introduction

Intended Use

Defibrillation Therapy

Precautions for Manual Defibrillation Therapy

Precautions for AED Therapy

Synchronized Cardioversion Therapy

Noninvasive Pacing Therapy (Optional)

12-Lead ECG Analysis (Optional)

Noninvasive Blood Pressure (NBP) Monitoring (Optional)

CO2 Monitoring (Optional)

Pulse Oximetry (SpO2) Monitoring (Optional)

Indications for Use

Manual Defibrillation

AED Therapy

Noninvasive Pacing Therapy

12-Lead ECG

Noninvasive Blood Pressure

Pulse Oximetry

Safety Considerations

Documentation and Training

2Getting Acquainted

Basic Orientation

Front Panel

Side Panels

Top Panel

Back Panel

M3538A Lithium Ion Battery

Battery Capacity

Battery Life

Operating Modes

Password Security

Display Views

General Status

Wave Sectors

Wave Sector 1

Wave Sectors 2-4

Changing Displayed Waveforms

Parameter Blocks

Soft Key Labels

Display Menus

Message Windows

High Contrast Display

Controls

Therapy Knob

General Function Buttons

Defibrillation Controls

Soft Keys

Indicators

Responding to Alarms

Entering Patient Information

Continued Use

Return to Owner

3Setting Up

Attaching the Carrying Case and Accessory Pouches

Storing Accessories

Connecting the ECG Cable

Connecting the SpO2 Cable

Connecting the NBP Interconnect Tubing

Connecting the Therapy Cable

Installing Paper

50mm Printer

75mm Printer

Installing Batteries

Charging Batteries

Battery Safety

Installing the AC Power Module

Installing the Data Card

Overview

Monitoring View

Preparing to Monitor ECG

Electrode Placement

Lead Selection

Lead Choices

Selecting the Lead

Arrhythmia Monitoring