Philips M3535A, M3536A User Manual

English

HeartStart MRx

M3535A/M3536A

Instructions For Use

Notice

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.

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

mark accordingly.

0123

Manufacturer

Philips Medical Systems 3000 Minuteman Road Andover, MA 01810 USA

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 trademarks of General Devices. Microstream FilterLine

™

, Rosetta-Rx™ and CAREpoint™ are

are registered trademarks of Oridion Medical

and

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

NPD

are registered trademarks of Steris Corp.

CidexPlus

is a registered trademark of Advanced Sterilization Products. Nellcor of Nellcor Puritan Bennett, Inc. TransPac registered trademark of ICU Medical, Inc. TruWave

and Coverage Plus

is a registered trademark

IV is a

is a registered trademark of Edwards Lifescience Corp. DTX Plus

™

is a trademark of Becton, Dickinson & Co.

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

1Table 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 CO 12-Lead ECG 3 Q-CPR 4 Invasive Pressures 4 Te m p e r a t u r e 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 Pan el 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 Sec to rs 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

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 SpO

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 EtCO

Selecting the Accessories 110

Setting Up Microstream EtCO2 Measurements 111

Using the Nasal FilterLine 111 Using the FilterLine and Airway Adapter 111

Measuring EtCO

EtCO2 and AwRR Alarms 112

Changing the EtCO2 Alarm Limits 113

110

112

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 Tu rn in g a Ne t wo rk e d D ev ic e Of f 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 Sh ock Tes t 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 Te m pe r at u r e 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

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).

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 dioxide (EtCO 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.

), temperature, and invasive pressures are also available. Measurements from these

), noninvasive blood pressure (NBP), carbon

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 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.

option. Q-CPR offers real-time measurement and

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 CO

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.

2Getting 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

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)

Label Recess

Mark Event button

Lead Select button

Display

External Power Indicator

Synchronized Cardioversion (Sync)

Sync

1-10

Pacer

Monitor

Adult Dose

120

150

100

Off

AED

Location of Networking icon

(if device is network enabled)

Ready For Use (RFU) Indicator

Therapy Knob

Charge

170

200

Select Energy

Charge

Shock

button

Shock button

Printer (50 mm)

Print Button

Printer Door

Printer Door Latch

Speaker

Alarm Pause button

Summary button

Soft keys (4 total)

Navigation buttons

Menu Select button

Microphone

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

), noninvasive blood pressure (NBP), invasive pressure (2), temperature and carbon dioxide

(SpO

(CO

). 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)

Therapy Connector

Data Card slot

Inlet

Port

Outlet Port

Temperature Port

™

ECG

Invasive Pressure ports

NBP Port

ECG Port

Port

SpO

ECG Out (Sync) 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 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 B

Compartment A

LAN Port

RS-232 Serial Port

AC Power Module

WARNING The HeartStart MRx LAN port is intended for connection to the IntelliVue Clinical Network or for

DC Power Input

Battery

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

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, SpO continuously, NBP measured every 15 minutes, and 20 200J discharges. A fully charged new battery provides approximately 3.5 hours of monitoring, with ECG, SpO pressures monitored continuously, NBP measured every 15 minutes, and pacing at 180ppm at 160mA.

, CO2, temperature, two invasive pressures monitored

, CO2, temperature, two invasive

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

12-Lead View

AED Mode AED View Used to analyze ECG and if necessary, perform semi-automatic external

Manual Defib Mode Code View Used to perform asynchronous and synchronous defibrillation

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.

Used to monitor ECG, take an optional 12-lead ECG, and monitor optional parameters such as SpO Temperature and for viewing Vital Signs Trending data.

defibrillation. Q-CPR available.

(cardioversion). Q-CPR available.

, EtCO2, NBP, Invasive Pressures,

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