Philips M3535A, M3536A User Manual

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English

Instructions For Use

HeartStart MRx

M3535A/M3536A

About This Edition

Publication number: 989803160421

Edition 1 Printed in the USA

To determine the product level version to which these 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.

Edition	Print Date
1	April 2009

NOTE: To obtain Instructions for Use for previous versions of the HeartStart MRx, visit the Philips Documentation and Downloads web site at http://www.philips.com/ProductDocs and search for resuscitation.

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.

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.

Rosetta-Lt™, Rosetta-Rx™ and CAREpoint™ are trademarks of General Devices. Microstream® and FilterLine® are registered trademarks of Oridion Medical Ltd. Smart CapnoLine™ is a trademark of Oridion Medical Ltd. Q-CPR® is a registered trademark of Laerdal Medical AS. The HeartStart MRx contains an Ezurio PC Card with Bluetooth® wireless technology. The Bluetooth wordmark and logos are owned by the Bluetooth SIG, Inc. and any use of such marks by Ezurio is under license. Coverage Plus® and Coverage Plus NPD® are registered trademarks of Steris Corp. CidexPlus® is a registered trademark of Advanced Sterilization Products. Nellcor® is a registered trademark of Nellcor Puritan Bennett, Inc. TransPac® IV is a registered trademark of ICU Medical, Inc. TruWave® is a registered trademark of Edwards Lifescience Corp. DTX Plus™ is a trademark of Becton, Dickinson & Co.

Notice

RelyOn and Virkon are registered trademarks or trademarks of E.I. du Pont de Nemours and Company or its affiliates. Other trademarks and trade names are those of their respective owners.

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

THIS PRODUCT IS NOT INTENDED FOR HOME USE. U.S. FEDERAL LAW RESTRICTS THIS DEVICE TO SALE ON OR BY THE ORDER OF A PHYSICIAN.

Medical Device Directive

The HeartStart MRx complies with the requirements of the Medical Device Directive 93/42/EEC and carries the 0123 mark accordingly.

Manufacturer

Philips Medical Systems

3000 Minuteman Road

Andover, MA 01810 USA

Authorized EU-representative

Philips Medizin Systeme Böblingen GmbH

Hewlett Packard Str. 2

71034 Böblingen

Germany

Canada EMC:ICES-001

U.S. FCC and Industry Canada Radio Compliance:

Contains FCC ID: PQC-WMTS-MODULE

When using the IntelliVue networking option, operation of this equipment requires the prior coordination with a frequency coordinator designated by the FCC for the Wireless Medical Telemetry Service. This device complies with Part 15 of the FCC rules and RSS-210 of Industry Canada. Operation is subject to the following conditions:

•This device may not cause harmful interference.

•This device must accept any interference received, including interference that may cause undesired operation.

Notice

Any changes or modifications to this equipment not expressly approved by Philips Medical Systems may cause harmful radio frequency interference and void your authority to operate this equipment.

China:

After Sales Service: Beijing MEHECO-PHILIPS Medical Equipment Service Center.

After Sales Service Address: No. 208, 2nd District, Wang Jing Li Ze Zhong Yuan, Chao Yang District, Beijing. Postal code: 100102.

Telephone: 8008100038.

Registration number: SFDA(I)20083211481. Product Standard number: YZB/USA 1863-2008.

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).

Warning

Radio frequency (RF) interference coming from devices other than the HeartStart MRx may degrade the performance of the 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.

Images of the HeartStart MRx display and menus appearing in this document are for illustration purposes only. Menu choices on your device are driven by the options you have purchased and selections you make in Configuration Mode.

iii

Table of Contents

	1 Introduction	1
	Overview	1
	Intended Use	2
	Indications for Use	3
	AED Therapy	3
	Manual Defibrillation	3
	Noninvasive External Pacing Therapy	3
	Pulse Oximetry	3
	Noninvasive Blood Pressure Monitoring	3
	End-tidal CO2	3
	12-Lead ECG	3
	Q-CPR	4
	Invasive Pressures	4
	Temperature	4
	ACI-TIPI	4
	TPI	4
	Safety Considerations	5
	Documentation and Training	5
	2 Getting Acquainted	7



	Basic Orientation	8
	Front Panel	8
	Side Panels	9
	Top Panel	10
	Back Panel	11
	M3538A Lithium Ion Battery	12
	Battery Capacity	12
	Battery Life	12
	Operating Modes	12
	Password Security	13
	Display Views	13
	General Status	14
	Wave Sectors	15
	Parameter Blocks	16
	Turning Parameters On/Off	16
	Soft Key Labels	16
	Menus	17
	Message Windows	18
	High Contrast Display	18

	Controls	19
	Therapy Knob	19
	General Function Buttons	20
	Defibrillation Controls	21
	Soft Keys	21
	Indicators	22
	Audio Recording	23
	Reviewing Recorded Audio	23
	Alarms	24
	Responding to Alarms	24
	Printing on Alarms	26
	Identifying Your Device	26
	Entering Patient Information	27
	Continued Use	27
	Printing Waveforms	28
	Return to Owner	29
	3 Setting Up	31



	Attaching the Carrying Case and Accessory Pouches	31
	Storing Accessories	33
	Connecting the ECG Cable	35
	Connecting the SpO2 Cable	36
	Connecting the NBP Interconnect Tubing	37
	Connecting the Invasive Pressures Cable	38
	Connecting the Temperature Cable	39
	Connecting the CO2 FilterLine	40
	Connecting the Therapy or Pads/CPR cables	41
	Installing Paper	42
	50 mm paper	42
	75mm Printer (optional)	43
	Installing Batteries	44
	Charging Batteries	44
	Battery Safety	44
	Installing the AC Power Module	45
	Installing the Data Card	46
		46
	4 ECG and Arrhythmia Monitoring	47

	Overview	47
	Monitoring View	48
	Preparing to Monitor ECG	49
	Electrode Placement	51
	Lead Selection	53
	Lead Choices	53
	Selecting the Lead	54
	Arrhythmia Monitoring	54

	Aberrantly-Conducted Beats	55
	Intermittent Bundle Branch Block	55
	Heart Rate and Arrhythmia Alarms	56
	Arrhythmia Alarm Latching	56
	INOP Messages	58
	Setting Alarms	59
	Changing Heart Rate or VTACH Alarm Limits	59
	Enabling/Disabling Heart Rate and Arrhythmia Alarms	59
	Responding to HR and Arrhythmia Alarms	59
	Displaying an Annotated ECG	60
	Arrhythmia Learning/Relearning	61
	Troubleshooting	61
	5 AED Mode	63



	Precautions for AED Therapy	63
	AED View	64
	Preparation	65
	Using AED Mode	66
	Step 1 - Turn the Therapy Knob to AED	67
	Step 2 - Follow Screen and Voice Prompts	67
	Step 3 - Press Shock Button, if Prompted	69
	Using Q-CPR in AED Mode	69
	Troubleshooting	69
	6 Manual Defibrillation and Cardioversion	71

	Overview	71
	Precautions for Manual Defibrillation Therapy	72
	Synchronized Cardioversion Therapy	72
	Code View	73
	Preparing for Defibrillation	74
	Using Multifunction Electrode Pads	74
	Using External Paddles	75
	Using Pediatric Paddles	76
	Using Internal Paddles	76
	Defibrillating (asynchronously)	77
	Performing Synchronized Cardioversion	79
	Preparing for Synchronized Cardioversion	79
	Delivering a Synchronized Shock	80
	Delivering Additional Synchronized Shocks	81
	Disabling the Sync Function	81
	Using Q-CPR in Manual Mode	81
	Troubleshooting	81
	7 Noninvasive Pacing	83

	Overview	83
	Alarms	84

vii

	Pacing View	85
	Demand Mode Versus Fixed Mode	86
	Preparing for Pacing	87
	Demand Mode Pacing	88
	Fixed Mode Pacing	89
	Defibrillating During Pacing	91
	Troubleshooting	91
	8 Pulse Oximetry	93

	Overview	93
	Understanding Pulse Oximetry	94
	Selecting a Sensor	95
	Applying the Sensor	96
	Monitoring SpO2	97
	Pleth Wave	98
	SpO2 Alarms	99
	Changing the SpO2 Alarm Limits	99
	SpO2 Desat Alarm	100
	Enabling/Disabling the SpO2 Alarms	100
	Pulse Rate Alarms	100
	Enabling/Disabling the Pulse Rate Alarms	101
	Changing the Pulse Rate Alarm Limits	101
	Disabling the SpO2 Monitoring Function	101
	Caring for Sensors	102
	Troubleshooting	102
	9 Noninvasive Blood Pressure	103



	Overview	103
	Preparing to Measure NBP	104
	Measuring NBP	106
	Changing the NBP Schedule	106
	Alarms	107
	Changing NBP Alarms	107
	Enabling/Disabling NBP Alarms	108
	Troubleshooting	108
10 Monitoring Carbon Dioxide		109

	Overview	109
	Preparing to Measure EtCO2	110
	Selecting the Accessories	110
	Setting Up Microstream EtCO2 Measurements	111
	Using the Nasal FilterLine	111
	Using the FilterLine and Airway Adapter	111
	Measuring EtCO2	112
	EtCO2 and AwRR Alarms	112
	Changing the EtCO2 Alarm Limits	113

viii

	Enabling/Disabling the EtCO2 Alarms	113
	Changing the AwRR Alarm Limits	113
	Changing the Apnea Time Alarm Limit	114
	Enabling/Disabling AwRR Alarms	114
	Disabling the EtCO2 Monitoring Function	114
	Troubleshooting	114
11 Invasive Pressures		115

	Overview	115
	Setting up for a Pressure Measurement	115
	Selecting a Pressure to Monitor	117
	Pressure Waves	118
	Zeroing the Pressure Transducer	119
	Zeroing Using the Menu Select Button	119
	Zeroing Using a Soft Key in Monitor Mode	119
	Calibration	121
	Known Calibration Factor	121
	Calibrating Reusable Transducer CPJ840J6	122
	Calibration Confirmation	123
	Last Zero/Calibration	124
	Non-Physiological Artifact Suppression	124
	Alarms	125
	Enabling/Disabling alarms	126
	Viewing/Changing/Setting Source for Alarms	126
	CPP Alarms	127
	Wedge	127
	Pulse	128
	Pulse Sources	128
	Changing Pulse Source	129
	Setting Pulse Alarms	129
	Enabling/Disabling Pulse Alarms	129
	Pulse Alarm Limits	130
	Changing Default Pulse Source and Alarm Limits	130
	Caring For Your Transducers and Probes	130
	Troubleshooting	130
12 Temperature		131

	Overview	131
	Selecting a Temperature Label	131
	Monitoring Temperature	132
	Alarms	132
	Setting Temperature Alarms	132
	Changing Temperature Alarm Limits	133
	Enabling/Disabling Temperature Alarms	133
	Changing Degree Units	133
	Disabling the Temperature Function	134

	Caring For Your Temperature Cables and Probes	134
	Troubleshooting	134
13 12-Lead ECG		135

	Overview	135
	Preparation	136
	Preview Screen	137
	Acquiring a 12-Lead ECG	138
	Acquiring a 12-lead ECG with ACI-TIPI and/or TPI Analysis	139
	Critical Values	143
	Culprit Artery	145
	12-Lead Report	146
	Accessing Stored Reports	148
	Improving Signal Quality	149
	Adjusting Wave Size	149
	12-Lead Filters	150
	Troubleshooting	150
14 Vital Signs Trending		151

	Overview	151
	Reviewing Trending Data	151
	About The Data Displayed	152
	Vital Signs Trending Report Parameter List Order	153
	Scrolling in the Vital Signs Trending Report	153
	Vital Signs Trending Report Intervals	153
	Adjusting Vital Signs Trending Report Interval	153
	Printing the Vital Signs Trending Report	154
	Exiting Vital Signs Trending Report	155
	Troubleshooting	155
15 Q-CPR and Data Capture		157

	Overview	157
	Preparing to Use Q-CPR	159
	Connecting the Pads/CPR Cable	159
	Connecting the CPR Meter to the Pads/CPR Cable	160
	Applying Multifunction Electrode Pads	160
	CPR Meter	161
	Attaching the CPR Meter Adhesive Pad	162
	Placing the CPR Meter on the Patient	163
	Starting CPR with the CPR Meter	164
	CPR Meter Display	165
	Q-CPR Feedback on the HeartStart MRx	167
	Advanced View	167
	Basic View	170
	Using Q-CPR in Manual Defib Mode	171
	Using Q-CPR in AED Mode	171

	Feedback Prompts	172
	Adjusting CPR Feedback Volume	173
	After Each Use	174
	Q-CPR Data Capture	174
	Q-CPR Feedback Setting	174
	Data and Events Recorded	175
	Research Storage Setting	175
	Reviewing Q-CPR Data	175
	Troubleshooting	175
16 Networking		177

	IntelliVue Networking Display	178
	Connecting to the Network	179
	Physical Connections	179
	Wired Connection	180
	Wireless Connection	180
	Combined Connection	181
	Configuring to Work on the Network	181
	Using the Device Location Option	182
	Network Settings	183
	Admit, Discharge, Transfer of Patients	184
	Admit	184
	Discharge	185
	Transfer	187
	Transfer Mode	188
	Sharing Information on the Network	190
	Patient Information	190
	Conflict Handling	192
	Viewing Patient Incident Data	193
	Alarms	193
	Printing	193
	Turning a Networked Device Off	193
	Leaving a Clinical Mode	194
	Events Logged	195
	INOPs, Alarms and Messages at the Information Center	195
	Troubleshooting	197
17 Configuration		199

	Overview	199
	Accessing the Configuration Menu	199
	Setting the Date and Time	200
	Modifying Settings	200
	Saving Configuration Settings to a Data Card	201
	Loading Configuration Settings from a Data Card	201
	Restoring the Default Settings	201
	Printing Configuration Settings	201

	Configurable Parameters	202
18 Working with Data		225

	Overview	225
	Initiating an Event Summary	226
	Entering Data Management Mode	226
	Copying from Internal Memory	227
	Viewing and Erasing the External Data Card	228
	Printing During a Patient Event	229
	Event Summaries	229
	Vital Signs Trending Reports	229
	12-Lead ECG Reports	229
	Printing Individual Events	230
	Printing from Data Management Mode	231
	Events Stored in Event Summary	232
	Marking Events	237
19 Data Transmission		239



	Overview	239
	Transmitting During a Critical Care Event	240
	Preparing for Transmission	241
	Modifying Reference IDs	241
	Setting up Bluetooth Transmissions	242
	Setting up Rosetta Transmissions	245
	Connecting Rosetta-Lt	246
	Setting Up for RS-232 Transmissions	247
	Transmitting in 12-Lead Mode	248
	Transmitting to a Manually Entered Fax Number	249
	Transmitting to a Personal Computer	249
	Periodic Clinical Data Transmission	250
	Transmitting Clinical Values	250
	PCDT Contents	250
	Starting a Periodic Clinical Data Transmission	252
	Ending a Periodic Clinical Values Transmission	253
	Transmitting Event Summaries Post Event	254
	Transmitting in Data Management Mode	255
	Tracking Data Transmission	257
	Transmission Errors	257
	Cancelling a Transmission	257
	Queuing Transmissions	258
	Finding Transmission Results	258
	Batch LAN Data Transfer	259
	Setting Up for Batch LAN Data Transfer	259
	Transferring Files with BLDT	260
	Troubleshooting	261

xii

20 Maintenance		263
	Overview	263
	Automated Tests	264
	Automated Test Summary	265
	Ready For Use Indicator	266
	Shift Checklist	267
	Weekly Shock Test	267
	HeartStart MRx Shift Checklist	268
	Operational Check	270
	Performing the Operational Check	271
	Operational Check Report	277
	Operational Check Summary	282
	Battery Maintenance	283
	Battery Life	283
	Charging Batteries	284
	Battery Calibration	284
	Storing Batteries	286
	Discarding Batteries	286
	Cleaning Instructions	287
	Monitor/Defibrillator	287
	Printer Printhead	287
	Paddles, Therapy Cable	288
	ECG Cable	288
	Carrying Case	289
	NBP Cuff	289
	SpO2 Sensor and Cable	289
	Invasive Pressures Transducer and Cable	289
	Temperature Probe and Cable	289
	CPR meter	289
	HeartStart MRx Disposal	290
	Empty Calibration Gas Cylinders Disposal	290
	CPR Meter and Adhesive Pads Disposal	290
21 Supplies & Accessories		291

	Overview	291
22 Troubleshooting		297

	Symptoms	298
	Audio Tones and Alarm Indications	318
	Calling for Service	319
23 Specifications and Safety		321

	Specifications	321
	General	321
	Defibrillator	321

xiii

ECG and Arrhythmia Monitoring	324
Display	326
Battery	326
Thermal Array Printer	327
Noninvasive Pacing	327
SpO2 Pulse Oximetry	328
NBP	329
Invasive Pressures	330
Temperature	331
EtCO2	331
AwRR	332
Calibration Gas for CO2 Measurement System	332
CPR Meter	333
Patient Adhesive Pads	333
12-Lead ECG	333
Networking	333
Patient Data Storage	334
Environmental (M3535A)	334
Environmental (M3536A)	335
Bluetooth	336
Symbol Definitions	337
Units and Abbreviations	340
Clinical Performance Summary - Defibrillation	341
Methods	341
Results	341
Conclusion	341
Clinical Performance Summary - Cardioversion	342
Methods	342
Results	342
Conclusion	343
Clinical Performance Summary - Internal Defibrillation	344
Overview	344
Methods	344
Results	344
Conclusion	344
Safety Considerations	345
General	345
Defibrillation	348
Battery	349
Supplies and Accessories	350
Electromagnetic Compatibility	350
Reducing Electromagnetic Interference	350
Restrictions for Use	351
Emissions and Immunity	351
Guidance and Manufacturer’s Declaration	351

xiv

Index

359

Introduction

Thank you for choosing the HeartStart MRx monitor/defibrillator. Philips Healthcare 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, a full range of defibrillation therapies, industryleading algorithms and a suite of data transmission options. 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 your 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).

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 (SpO2), noninvasive blood pressure (NBP), carbon dioxide (EtCO2), temperature, and invasive pressures are also available. Measurements from these parameters are presented on the display. Alarms are available to alert you to changes in the patient’s condition. You can also display a Vital Signs Trending Report to view all key parameters and their measurements at a glance.

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. In addition, there are several STEMI decision support tools, including STEMI Culprit Artery, Critical Values and the Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (ACI-TIPI) and Thrombolytic Predictive Instrument (TPI) algorithms. You can also transmit 12-Lead reports and Event Summaries via the 12Lead ECG Transmission and Event Summary Data Transfer options. Other transmission options are available. See “Data Transmission” on page 239.

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.

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 on the display.

1 Introduction

Intended Use

The Manual Defib and AED modes incorporate Philips’ low energy SMART Biphasic waveform for defibrillation. Both modes also offer the Q-CPR® option. Q-CPR offers real-time measurement and corrective feedback on the rate, depth/complete release of compressions (and lack of CPR activity) and ventilation rate. The HeartStart MRx displays a CPR Timer and compression counter to assist with protocol management.

The HeartStart MRx also has an optional Audio function which allows you to record audio during a patient event.

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.

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. The prominently displayed 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, such as Event Summaries, 12-Lead Reports and Vital Signs Trending, in its internal memory. 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, or you can send the data electronically via several methods to your destination point.

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 Chapter 17 “Configuration” for more details.

Intended Use

The HeartStart MRx is intended 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.

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.

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.

AED Therapy

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 and pulseless.

Manual Defibrillation

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

Noninvasive External 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.

Pulse Oximetry

The SpO2 option is intended for use when it is beneficial to assess a patient’s oxygen saturation level.

Noninvasive Blood Pressure Monitoring

The NBP option is intended for noninvasive measurement of a patient’s arterial blood pressure.

End-tidal CO2

The EtCO2 option is intended for noninvasive monitoring of a patient’s exhaled carbon dioxide and to provide a respiration rate.

12-Lead ECG

The 12-Lead ECG function is to provide a conventional diagnostic 12-Lead ECG report, which may include measurements and interpretative statements.

1 Introduction

Indications for Use

Q-CPR

The Q-CPR option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time).

The Q-CPR option is contraindicated as follows:

•The Q-CPR option is contraindicated for use on neonatal and pediatric patients (under 8 years of age or weighing less that 25 kg).

•The Q-CPR option is not for use when CPR is contraindicated.

Invasive Pressures

The Invasive Pressures option is indicated for measuring arterial, venous, intracranial and other physiological pressures on patients.

Temperature

The Temperature option is indicated for measuring temperature in patients.

ACI-TIPI

This device is intended to be an aid to clinicians by focusing their attention on indicators of Acute Cardiac Ischemia.

TPI

Indications for Use: Physiological purpose: To aid the clinician deciding whether to administer thrombolytic therapy or to provide another avenue of treatment; Condition: Patient is a potential candidate for thrombolytic therapy; Patient Population: adult (35 to 75 years) patients diagnosed as having symptoms of Acute Myocardial Infarction; Body or type of tissue interacted with: No body or tissue contact. Prescription versus over-the-counter: TPI is a prescription device.

Contraindications: NOTE: The Thrombolytic Predictive Instrument (TPI) is contraindicated for patients with conditions which mimic acute myocardial infarction. Some of these conditions are: Prinzmetal variant angina, acute pericarditis, acute myocarditis, cardiomyopathy, and primary and secondary cardiac neoplasms.

The Thrombolytic Predictive Instrument (TPI) is also contraindicated for patients with conditions whom the administration of thrombolytics is contraindicated. Some of these conditions are: aortic dissection, acute myocardial infarction due to bacterial endocarditis, vasculitis, intracardiac thrombi, and acute nonsuppurative and suppurative pericarditis mimicking acute myocardial infarction.

These situations, as well as Posterior Acute Myocardial Infarction, were not considered or covered in the development of the predictive instrument calculations.

NOTE See note on page 140 for additional details on contraindications for TPI therapy.

Safety Considerations

1 Introduction

Safety Considerations

General warnings and cautions that apply to use of the HeartStart MRx are provided in “Specifications and Safety” on page 321. 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.

WARNING Use only supplies and accessories approved for use with your HeartStart MRx. Use of non-approved supplies and accessories could affect performance and results.

WARNING Use single-use supplies and accessories only once.

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 Improving ECG Quality 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 Videotape and DVD

•To purchase additional copies of the Instructions for Use or Quick Cards, visit the Philips Healthcare eStore at: www.philips.com/healthcarestore.

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

Getting Acquainted

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

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

NOTE If your HeartStart MRx does not have some of the optional functionality listed in this chapter, disregard these controls and the related information described throughout this manual.

2 Getting Acquainted

Basic Orientation

HeartStart MRx controls, indicators, and connections are carefully organized.

Front Panel

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

Figure 1 Basic Orientation (Front)

External Power Indicator

Label Recess

Mark Event button

Lead Select button

Display

Synchronized

Cardioversion (Sync)

c Syn

								Adult
							120	Dose
				ib		100	120	150
			f		70			170
	l	D	e		70
	l	D		50
	a			50
u
n
a			30
M			30
		20
			15
				1-10
			Pacer			On	Off	On

Monitor AED

Location of Networking icon

(if device is network enabled)

Ready For Use

(RFU) Indicator

Therapy Knob

		Charge
		button
200	1
Select
Energy		Shock
Charge	2	Shock
	2	button
Shock	3

Printer (50 mm)

Button

Printer Door

Latch

Speaker

Alarm Pause button Summary	Soft keys	Navigation	Microphone
button	(4 total)	buttons	Menu Select button

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 (SpO2), noninvasive blood pressure (NBP), invasive pressure (2), temperature and carbon dioxide (CO2). The ECG port may be used to connect a 3-, 5-, or 10-lead patient cable. The ECG Out jack may be used to connect to an external monitor.

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

Figure 2 Basic Orientation (Right/Left Sides)

CO2 Inlet

Port

CO2

Outlet Port

Temperature

Port

ECG Out

(Sync) Jack

CO2
				™
				a
			t r	e
	r o	s
ic	r o
ic
M

ECG

Therapy

Connector

Data Card slot

Invasive Pressure ports

NBP Port

ECG Port

SpO2 Port

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 also 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 or setting up a wireless connection to the IntelliVue Network. The LAN port is for a wired connection to the IntelliVue Network or for Batch LAN Data Transfer.

Figure 4 Basic Orientation (Back)

	Battery
Battery/AC	Compartment A
Compartment B

LAN Port

RS-232

Serial Port

AC Power		Module			Input	Battery
			DC Power

WARNING The HeartStart MRx LAN port is intended for connection to the IntelliVue Clinical Network or for Batch LAN Data Transfer. It should only be used for connection to devices that comply with IEC 60950-1 and IEC 60601-1. During real-time patient monitoring, the HeartStart MRx wired LAN connector should only be connected to the IntelliVue Network. For post-event Batch LAN Data Transfer, the HeartStart MRx should only be connected to the facility network.

The RS-232 Serial Port is intended for connection to the IntelliVue wireless backpack. It is also for connecting with the Rosetta-Lt and cellphones for data transmission. Improper system operation may result if any other device is connected to this port.

2 Getting Acquainted

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 at least 20% of capacity. Press the fuel gauge button to illuminate the fuel gauge.

CAUTION A battery should be used as the primary power source. AC/DC should be used as a secondary source, if desired. If an AC/DC power module is used as the only power source, the HeartStart MRx takes longer to charge to the desired energy level and, in the event of power loss, all settings reset to the default settings and a new incident is created when power is returned. All stored data remains intact and can be found by retrieving the previous incident. Keep your unit charged.

Battery Capacity

A new, fully-charged M3538A battery, operating at room temperature 25oC (77oF), provides at least 5 hours of monitoring, with ECG, SpO2, CO2, temperature, two invasive pressures monitored continuously, NBP measured every 15 minutes, and 20 200J discharges. A fully charged new battery provides approximately 3.5 hours of monitoring, with ECG, SpO2, CO2, temperature, two invasive pressures monitored continuously, NBP measured every 15 minutes, and pacing at 180ppm at 160mA.

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.

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	Used to monitor ECG, take an optional 12-lead ECG, and monitor
	12-Lead View	optional parameters such as SpO2, EtCO2, NBP, Invasive Pressures,
		Temperature and for viewing Vital Signs Trending data.
AED Mode	AED View	Used to analyze ECG and if necessary, perform semi-automatic external
		defibrillation. Q-CPR available.

Manual Defib Mode	Code View	Used to perform asynchronous and synchronous defibrillation
		(cardioversion). Q-CPR available.

Pacer Mode	Pacing View	Used to perform demand or fixed mode pacing.

NOTE Upon returning to a clinical mode from a non-clinical mode such as Configuration or Data Management, all settings reset to the default settings.

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