Stryker LIFEPAK 15 Operating Instructions Jan 2019

MONITOR/DEFIBRILLATOR

Operating Instructions

Important Information

Device Tracking The U.S. Food and Drug Administration requires defibrillator manufacturers and distributors to track the location of their defibrillators. If the device is located somewhere other than the shipping address or the device has been sold, donated, lost, stolen, exported, destroyed, permanently retired from use, or if the device was not obtained directly from Physio-Control, please do one of the following: register the device at http://www.physio-control.com, call the device registration phone line at 1.800.426.4448, or use one of the postage-paid address change cards located in the back of this manual to update this vital tracking information.

Text Conventions Throughout these operating instructions, special text characters (for example, CAPITAL LETTERS such as CHECK PATIENT and SPEED DIAL) are used to indicate labels, screen messages, and voice prompts.

Applicable Products These operating instructions are for use with the following product catalog numbers.

99577-001368, 99577-001372, 99577-001373, 99577-001588, 99577-001930, 99577-001931, 99577-001932, 99577-001933, 99577-001934, 99577-001935, 99577-001936, 99577-001937, 99577-001938, 99577-001939, 99577-001940, 99577-001941, 99577-001942, 99577-001943, 99577-001944, 99577-001945, 99577-001946, 99577-001947, 99577-001948, 99577-001949, 99577-001950, 99577-001951, 99577-001952, 99577-001953, 99577-001954, 99577-001955, 99577-001956, 99577-001957, 99577-001958, 99577-001959, 99577-001960, 99577-001961, 99577-001962, 99577-001963, 99577-001964, 99577-001965, 99577-001966

Physio-Control or its affiliates own, use, or have applied for the following trademarks or service marks: LIFEPAK, LIFEPAK CR, LIFEPAK EXPRESS, REDI-PAK, LIFENET, QUIK-LOOK, QUIK-COMBO, CODE SUMMARY, Shock Advisory System, CODE-STAT, DT EXPRESS, SunVue, and cprMAX. All other trademarks are trademarks of their respective owners or holders. The Oridion medical capnography in this product is covered by one or more of the following US patents: 6,428,483; 6,997,880; 5,300,859; 6,437,316 and their foreign equivalents. Additional patent applications pending. Specifications are subject to change without notice.

©2019 Physio-Control, Inc. Publication Date: 01/2019 3314911-011

Contents

Chapter 1 Preface

11

Introduction ... 13 Intended Use... 13 Modes of Operation ... 14 Chapter 2 Safety Information

15

Terms ... 17 General Dangers and Warnings ... 17 Chapter 3 Basic Orientation

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Front View ... 23 Back View ... 33 Batteries ... 35 Home Screen ... 37 Alarms ... 41 Options ... 43 Events ... 45 Chapter 4 Monitoring

47

Monitoring the ECG ... 49 Acquiring a 12-Lead ECG ... 61 Monitoring SpO2, SpCO, and SpMet ... 71 Monitoring Noninvasive Blood Pressure ... 83 Monitoring ETCO2 ... 91 Monitoring Invasive Pressure ... 99 Monitoring Continuous Temperature... 107 Vital Sign and ST Segment Trends ... 111 Chapter 5 Therapy

117

General Therapy Warnings and Cautions ... 119 Therapy Electrode and Standard Paddle Placement ... 121 Automated External Defibrillation (AED) ... 123 Manual Defibrillation ... 137 Synchronized Cardioversion Procedure ... 143 Noninvasive Pacing ... 148 Pediatric ECG Monitoring and Manual Mode Therapy Procedures ... 154 ©2019 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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Chapter 6 Paddle Accessory Options

155

QUIK-COMBO Therapy Electrodes ... 157 Standard Paddles ... 160 Sterilizable Internal Defibrillation Paddles ... 164 Chapter 7 Data Management

165

Patient Records and Reports ... 167 Memory Capacity... 173 Managing Current Patient Records ... 173 Managing Archived Patient Records ... 175 Chapter 8 Data Transmission

179

About Transmitting Patient Records and Reports ... 181 Preparing the Monitor for Transmission ... 182 Using Bluetooth Wireless Communication ... 182 Using a Direct Connection ... 187 Transmitting Reports ... 189 Considerations When Transmitting Data ... 191 Troubleshooting Tips ... 192 Chapter 9 Power Adapter

195

Basic Orientation ... 197 Using the Power Adapter... 199 General Maintenance ... 202 Warranty... 203 Chapter 10 Maintaining the Equipment

205

General Maintenance and Testing ... 207 Battery Maintenance ... 215 Cleaning the Device ... 218 Storing the Device ... 218 Loading Paper... 219 General Troubleshooting Tips ... 220 Service and Repair... 224 Service Life ... 224 Product Recycling Information ... 225

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LIFEPAK 15 Monitor/Defibrillator Operating Instructions

Warranty... 225 Accessories... 226 Appendix A Specifications and Performance Characteristics

229

Specifications and Performance Characteristics ... 231 Appendix B Screen Messages

253

Summary of Screen Messages ... 255 Appendix C Defibrillation Clinical Summaries

261

Defibrillation of Ventricular Fibrillation and Ventricular Tachycardia ... 263 External Cardioversion of Atrial Fibrillation... 265 Intra-Operative Ventricular Defibrillation... 269 Clinical Summary: Monophasic vs. Biphasic Waveforms: Out-of-Hospital Trial ...272 Appendix D Shock Advisory System

275

Overview ... 277 Performance Verification ... 278 Appendix E SpO2 Specifications and Validation

283

SpO2 Specifications and Validation ... 285 Masimo Clinical Validation Data ... 293 Nellcor Clinical Validation Data... 294 Appendix F Electromagnetic Compatibility Guidance

295

Electromagnetic Compatibility Guidance ... 297 Appendix G Symbols

303

Symbols ... 305 Index

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Chapter 1

Preface This chapter provides a brief introduction to the LIFEPAK® 15 monitor/defibrillator and describes the product’s intended use.

Introduction ... 13 Intended Use ... 13 Modes of Operation... 14

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LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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Chapter 1 | Preface

Introduction The LIFEPAK 15 monitor/defibrillator is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. These operating instructions include information and procedures related to all features of the LIFEPAK 15 monitor/defibrillator. Your LIFEPAK 15 monitor/defibrillator may not have all of these features. These operating instructions describe the operation of the LIFEPAK 15 monitor/defibrillator when the factory default settings are used. The factory default settings for all setup options are identified in table, Setup Options Factory Default Settings (on page 250). Your device may be set up with different default settings, based on your protocols. For information about changing default settings, see the LIFEPAK 15 Monitor/Defibrillator Setup Options provided with your device. IMPORTANT! Some LIFEPAK 15 monitor/defibrillator accessories are not interchangeable with accessories that are used with other LIFEPAK monitor/defibrillators. Specific accessory incompatibilities are noted in the related sections.

Intended Use The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel. For information about training options, contact your local Physio-Control representative. The LIFEPAK 15 monitor/defibrillator can be used in out-of-doors and indoor emergency care settings within the environmental conditions specified in Appendix A. The monitor/defibrillator is designed to be used during ground transportation. Monitoring and therapy functions may only be used on one patient at a time. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older. For additional intended use information, and information about the indications and contraindications of the monitoring and therapy functions, see the individual sections identified below. •

ECG Monitoring

See Monitoring the ECG (on page 49)

Standard feature

•

12-Lead Electrocardiography

See Acquiring a 12-Lead ECG (on page 61)

Optional

•

SpO2, SpCO, and SpMet Monitoring

See Monitoring SpO2, SpCO, and SpMet (on page 71)

Optional

•

Noninvasive Blood Pressure Monitoring

See Monitoring Noninvasive Blood Pressure Optional (on page 83)

•

End-Tidal CO2 Monitoring

See Monitoring ETCO2 (on page 91)

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Optional

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Modes of Operation •

Invasive Pressure Monitoring

See Monitoring Invasive Pressure (on page 99)

Optional

•

Temperature Monitoring

See Monitoring Continuous Temperature (on page 107)

Optional

•

Vital Sign and ST Segment Trends

See Vital Sign and ST Segment Trends (on page 111)

Optional

•

Automated External Defibrillation

See Automated External Defibrillation (AED) Standard feature (on page 123)

•

Manual Defibrillation

See Manual Defibrillation (on page 137)

Standard feature

•

Noninvasive Pacing

See Noninvasive Pacing (on page 148)

Standard feature

Modes of Operation The LIFEPAK 15 monitor/defibrillator has the following modes of operation:

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•

AED mode-for automated ECG analysis and a prompted treatment protocol for patients in cardiac arrest.

•

Manual mode-for performing manual defibrillation, synchronized cardioversion, noninvasive pacing, and ECG and vital sign monitoring.

•

Archive mode-for accessing stored patient information.

•

Setup mode-for changing default settings of the operating functions. For more information, see the LIFEPAK 15 Monitor/Defibrillator Setup Options provided with your device.

•

Demo mode-for simulated waveforms and trend graphs for demonstration purposes.

•

Service mode-for authorized personnel to perform diagnostic tests and calibrations. For more information, see the LIFEPAK 15 Monitor/Defibrillator Service Manual.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

Chapter 2

Safety Information This chapter provides important information to help you operate the LIFEPAK 15 monitor/defibrillator. Familiarize yourself with all of these terms and warnings.

Terms ... 17 General Dangers and Warnings ... 17

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Chapter 2 | Safety Information

Terms The following terms are used either in these operating instructions or on the LIFEPAK 15 monitor/defibrillator: Danger: Immediate hazards that will result in serious personal injury or death. Warning: Hazards or unsafe practices that may result in serious personal injury or death. Caution: Hazards or unsafe practices that may result in minor personal injury, product damage, or property damage.

General Dangers and Warnings The following are general danger and warning statements. Other specific warnings and cautions are provided as needed in other sections of these operating instructions.

Explosion Hazard Do not use this defibrillator in the presence of flammable gases or anesthetics.

Shock Hazard The defibrillator delivers up to 360 joules of electrical energy. Unless properly used as described in these operating instructions, this electrical energy may cause serious injury or death. Do not attempt to operate this device unless thoroughly familiar with these operating instructions and the function of all controls, indicators, connectors, and accessories.

Shock Hazard Do not disassemble the defibrillator. It contains no operator serviceable components and dangerous high voltages may be present. Contact authorized service personnel for repair.

Possible Device Failure Do not modify the device.

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General Dangers and Warnings Shock or Fire Hazard Do not immerse any portion of this defibrillator in water or other fluids. Avoid spilling any fluids on defibrillator or accessories. Spilled liquids may cause the defibrillator and accessories to perform inaccurately or fail. Do not clean with ketones or other flammable agents. Do not autoclave or sterilize this defibrillator or accessories unless otherwise specified.

Possible Fire Use care when operating this device close to oxygen sources (such as bag-valve-mask devices or ventilator tubing). Turn off gas source or move source away from patient during defibrillation.

Possible Electrical Interference With Device Performance Equipment operating in close proximity may emit strong electromagnetic or radio frequency interference (RFI), which could affect the performance of this device. If use of equipment in close proximity is necessary, observe the device to verify normal operation in the configuration in which the device will be used. RFI may result in distorted ECG, incorrect ECG lead status, failure to detect a shockable rhythm, cessation of pacing, or incorrect vital sign measurements. Avoid operating the device near cauterizers, diathermy equipment, metal detectors, or electronic articles surveillance gates. Do not rapidly key EMS radios on and off. Refer to Electromagnetic Compatibility Guidance (on page 295) for recommended distances of equipment. Contact Physio-Control Technical Support if assistance is required.

Possible Electrical Interference with Device Performance Portable radio frequency (RF) communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than the distance listed in the Separation Distances (on page 300) table to any part of the LIFEPAK 15 monitor/defibrillator, including cables specified by Physio-Control. Shorter distances may result in compromised performance.

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LIFEPAK 15 Monitor/Defibrillator Operating Instructions

Chapter 2 | Safety Information Possible Electrical Interference This defibrillator should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the defibrillator should be observed to verify normal operation in the configuration in which it will be used.

Possible Electrical Interference Using cables, electrodes, or accessories not specified for use with this defibrillator may result in increased emissions or decreased immunity from electromagnetic or radio frequency interference (RFI) which could affect the performance of this defibrillator or of equipment in close proximity. Use only parts and accessories specified in these operating instructions.

Possible Electrical Interference This defibrillator may cause electromagnetic interference (EMI) especially during charge and energy transfers. EMI may affect the performance of equipment operating in close proximity. Verify the effects of defibrillator discharge on other equipment prior to using the defibrillator in an emergency situation, if possible.

Possible Equipment Damage Use only ECG cables that are specified for use with this device. Protection of the device against defibrillator discharge is dependent on the use of ECG cables that are specified by Physio-Control.

Possible Improper Device Performance Using other manufacturers’ cables, electrodes, power adapters, or batteries may cause the device to perform improperly and may invalidate the safety agency certifications. Use only the accessories that are specified in these operating instructions.

Possible Improper Device Performance Changing factory default settings will change the behavior of the device. Changes to the default settings must only be made by authorized personnel.

©2019 Physio-Control, Inc.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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General Dangers and Warnings Possible Device Shutdown Always have immediate access to a spare, fully charged, properly maintained battery. Replace the battery when the device displays a low battery warning.

Safety Risk And Possible Equipment Damage MR unsafe: Keep the defibrillator away from magnetic resonance imaging (MRI) equipment.

Possible Patient Burns A defect in the neutral electrode connection on HF surgical equipment could cause burns at the lead or sensor site and damage to the monitor/defibrillator. Do not apply patient leads, sensors, or catheters when using high frequency (HF) electrosurgical equipment. Note: The features of the LIFEPAK 15 monitor/defibrillator which could come in either direct or casual contact with the patient or caregiver during normal use are not made with natural rubber latex.

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LIFEPAK 15 Monitor/Defibrillator Operating Instructions

Chapter 3

Basic Orientation This chapter provides a basic orientation to the LIFEPAK 15 monitor/defibrillator device and its controls, indicators, and connectors.

Front View... 23 Back View ... 33 Batteries ... 35 Home Screen ... 37 Alarms ... 41 Options ... 43 Events ... 45

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Chapter 3 | Basic Orientation

Front View This figure shows the front of the LIFEPAK 15 monitor/defibrillator. The front of the device is described in the following sections.

Figure 1 Front View

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LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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Front View

Area 1

Figure 2 Area 1 Controls

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LIFEPAK 15 Monitor/Defibrillator Operating Instructions

Chapter 3 | Basic Orientation Table 1 Area 1 Controls

CONTROL

DESCRIPTION

FOR MORE INFORMATION

VF dose label

Physio-Control recommended energy dose for adult Ventricular Fibrillation (VF).

See Biphasic Clinical Summaries at www.physio-control.com/Biphasic

1

ON

Turns device ON or OFF. LED illuminated when ON. Press and hold to turn device off.

2

ENERGY SELECT

Increases or decreases energy level in Manual mode.

See Manual Defibrillation (on page 137)

3

CHARGE

Charges the defibrillator in Manual mode.

See Manual Defibrillation (on page 137)

Shock button. Initiates discharge of defibrillator energy to patient. LED flashes when charging is complete.

See Manual Defibrillation (on page 137)

Auxiliary power indicator. LED illuminated when defibrillator is connected to auxiliary AC or DC power source, whether defibrillator is turned on or off.

See Using the Power Adapter (on page 199)

Battery charging indicator. LED illuminated See AC Power Adapter Operation when installed batteries are fully charged. (on page 199) LED flashes when either battery is charging. LED is not illuminated when no batteries are installed or a battery is unable to be charged. Illuminated Service LED indicates a condition exists that prevents or could prevent normal defibrillator operation. CPR

ANALYZE

See General Troubleshooting Tips (on page 220)

Controls CPR metronome. LED illuminated See Using the CPR Metronome (on when metronome function is active. page 141) Activates Shock Advisory System™ (AED mode). LED illuminated when AED is analyzing the ECG, and flashes when user is prompted to push ANALYZE.

See Automated External Defibrillation (AED) (on page 123)

LEAD

Changes ECG lead.

See Selecting ECG Lead (on page 50)

SIZE

Changes ECG size.

See Changing ECG Size (on page 51)

SYNC

Activates Synchronized mode. LED illuminated when Sync mode is active and flashes with detection of each QRS.

©2019 Physio-Control, Inc.

See Synchronized Cardioversion Procedure (on page 143)

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

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Front View

Area 2

Figure 3 Area 2 Controls

Table 2 Area 2 Controls

26

CONTROL

DESCRIPTION

FOR MORE INFORMATION

PACER

Activates pacer function. LED illuminated when See Noninvasive Pacing (on function is activated and flashes with each current page 148) pulse.

RATE

Increases or decreases pacing rate.

See Noninvasive Pacing (on page 148)

CURRENT

Increases or decreases pacing current.

See Noninvasive Pacing (on page 148)

PAUSE

Temporarily slows pacing rate.

See Noninvasive Pacing (on page 148)

LIFEPAK 15 Monitor/Defibrillator Operating Instructions