Philips HeartStart MRx User manual (2005)
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
i
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
®
34
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
ii
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
2
88
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
2
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
iv
2
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
v
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
vi
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
Copyright
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
.
Copyright © 2005
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.
1
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.
2
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).
1
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
2
), noninvasive blood Pressure (NBP), and
2
3
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.
4
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.
5
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
2
during a respiratory cycle in a “waveform” format.
2
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.
2
6
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.
7
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
2
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.
8
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.
2
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
9
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
c
n
y
S
u
u
n
n
a
a
M
M
l
l
a
a
20
M
30
15
P
e
e
D
D
1-10
acer
onitor
A
D
120
b
b
150
i
i
100
f
f
70
50
n
O
O
n
O
ff
AED
Ready For Use (RFU)
Indicator
Therapy Knob
dult
ose
170
200
S
elect
E
nergy
1
C
harge
CHARGE button
SHOCK button
2
S
hock
3
Printer
(50 mm)
Printer Door
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.
10
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
2
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)
2
O
C
r
c
i
M
1
2
™
m
a
e
r
t
s
o
G
C
E
NBP Port
ECG Port
SpO2 Port
Data Card
ECG Out (Sync)
Jack
RJ11 Telephone
G
C
E
Jack
11
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)
12
Basic Orientation 2 Getting Acquainted
L
A
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
13
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
2
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.
2
14
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
C
harge
2
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
90
120120
6060
Pulse
000
02 Mar 2003 10:52Adult Paced
HH:MM:SS
NBP q 30 10:40
000/000(000)
AwRR
000
#4
50
000
30
120
50
SYS
160
90
rhythm statusrhythm status
30
8
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.
15
2 Getting Acquainted Display Views
y
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
AA
No Battery Empty Battery 25% Capacity 50% Capacity 75% Capacity 100% Capacit
A
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.
16
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.
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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
2
and EtCO2 measurements are activated when the associated parameter cable/tubing is
SpO
2
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
2
18
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
No
19
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.
20
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