LIFEPAK 20e Defibrillator Monitor Operating Instructions

Operating Instructions

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LIFEPAK 20e DEFIBRILLATOR/MONITOR ®

Operating Instructions

LIFEPAK 20e DEFIBRILLATOR /MONITOR ®

OPERATING INSTRUCTIONS

Important Information !USA Rx Only !USA 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 tracking coordinator 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 are used to indicate labels, screen messages, and voice prompts: • Operating control labels: CAPITAL LETTERS such as ON/OFF and SHOCK. • Screen messages and voice prompts: CAPITAL ITALICIZED LETTERS such as CONNECT ELECTRODES.

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

99507-000094, 99507-000095, 99507-000103, 99507-000107

Physio-Control or its affiliates own, use, or have applied for the following trademarks or service marks: LIFEPAK, FAST-PATCH, DERMA-JEL, QUIK-LOOK, QUIK-COMBO, CodeManagement Module, ADAPTIV, CODE-STAT, CODE SUMMARY, REDI-PAK, and Shock Advisory System. All other trademarks are trademarks of their respective owners or holders. Specifications are subject to change without notice. ©2019 Physio-Control, Inc. Publication Date: 01/2019

3313187-034

CONTENTS

Preface About Automated External Defibrillation ... x About Defibrillation Therapy ...xi About Noninvasive Pacing ...xii About SpO2 Monitoring ...xii About ECG Monitoring ...xii About EtCO2 Monitoring ... xiii

1 Safety Information Terms... 1-2 General Warnings and Cautions... 1-2 Symbols ... 1-5

2 Basic Orientation Introduction ... 2-2 Unpacking and Inspecting ... 2-3 Controls, Indicators, and Connectors ... 2-4 Area 3... 2-7 Area 4... 2-9 Area 7... 2-12 Changing Printer Paper... 2-14 Back View... 2-15 Side View of CodeManagement Module ... 2-16 Entering Patient Data... 2-17 Setting Alarms ... 2-19 Managing Alarms ... 2-21 Connecting to Power ... 2-22 AC Operation... 2-22

iii

Battery Operation ...2-22 LIFEPAK 20e Defibrillator/Monitor Battery ...2-22 CodeManagement Module Battery ...2-25

3 Monitoring Monitoring the ECG...3-2 ECG Monitoring Warning...3-2 Selecting ECG Lead and Size ...3-2 Adjusting the Systole Tone Volume...3-3 Monitoring with the Patient ECG Cable ...3-5 Troubleshooting Tips for ECG Monitoring ...3-7 Monitoring SpO2 ...3-9 SpO2 Warnings and Cautions ...3-9 When to Use a Pulse Oximeter ...3-10 How a Pulse Oximeter Works...3-10 SpO2 Monitoring Considerations...3-11 SpO2 Monitoring Procedure ...3-12 SpO2 Waveform ...3-12 SpO2 Volume ...3-12 Sensitivity...3-12 Averaging Time...3-13 Pulse Oximeter Sensors ...3-13 Cleaning...3-13 Troubleshooting Tips for SpO2...3-14 Monitoring EtCO2...3-16 EtCO2 Warnings and Cautions...3-16 How Capnography Works...3-17 EtCO2 Monitoring Waveform Analysis ...3-18 EtCO2 Monitoring Procedure...3-19 CO2 Display...3-20 CO2 Alarms ...3-20 CO2 Detection ...3-21 Cleaning...3-21 Troubleshooting Tips for EtCO2 ...3-22

4 Therapy General Therapy Warnings and Cautions...4-2 Therapy Electrode and Standard Paddle Placement ...4-3 Anterior-lateral Placement ...4-3 Anterior-posterior Placement ...4-3 Special Placement Situations ...4-4 Automated External Defibrillation...4-5 AED Warnings ...4-5 AED Setup ...4-5 AED Procedure...4-6 Special AED Setup Options...4-10 Troubleshooting Tips for AED Mode...4-13 Switching from AED to Manual Mode ...4-14 Manual Defibrillation...4-14 Manual Defibrillation Warnings ...4-15 Impedance ...4-15 Defibrillation Procedure ...4-16 CPR Metronome ...4-17

LIFEPAK 20e Defibrillator/Monitor Operating Instructions

Synchronized Cardioversion Procedure ... 4-18 Remote Synchronization Procedure... 4-20 Pediatric Defibrillation ... 4-21 Pediatric Paddle Placement ... 4-21 Defibrillation Procedure ... 4-22 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion ... 4-22 Noninvasive Pacing ... 4-25 Noninvasive Pacing Warnings... 4-25 Demand and Nondemand Pacing ... 4-25 Noninvasive Pacing Procedure ... 4-26 Troubleshooting Tips for Noninvasive Pacing ... 4-27

5 Paddle Accessory Options Therapy Electrodes... 5-2 About Therapy Electrodes ... 5-2 Electrode Placement ... 5-3 Cable Connection ... 5-4 ECG Monitoring and Therapy Procedures ... 5-4 Replacing and Removing Electrodes ... 5-4 Testing... 5-5 Cleaning and Sterilizing... 5-5 Standard Paddle Set (Optional) ... 5-6 About the Standard Paddle Set... 5-6 Accessing the Pediatric Paddles ... 5-6 Replacing the Adult Paddle Attachment ... 5-7 Cleaning the Standard Paddle Set ... 5-7 Sterilizable Internal Defibrillation Paddles... 5-8

6 Data Management Overview of Data Storage and Retrieval... 6-2 Data Storage ... 6-2 Report Types... 6-2 Memory Capacity ... 6-2 CODE SUMMARY Report ... 6-2 Preamble ... 6-3 Event/Vital Signs Log ... 6-3 Waveform Events ... 6-4 CODE SUMMARY Format ... 6-5 Managing Archived Patient Records... 6-7 Entering Archives Mode... 6-7 Printing Archived Patient Reports ... 6-7 Transmitting Archived Patient Records... 6-9 Editing Archived Patient Records ... 6-10 Deleting Archived Patient Records ... 6-11 Overview of Connections for Transmitting Reports ... 6-12 Data Transfer from TrueCPR Device... 6-13 Troubleshooting Tips for Data Transmission ... 6-14

7 Maintaining the Equipment General Maintenance and Testing... 7-2 Maintenance and Testing Schedule ... 7-2 Daily Auto Test ... 7-3 User Test ... 7-4

Cleaning...7-5 Function Checks ...7-5 General Troubleshooting Tips ...7-10 Service and Repair...7-12 Product Recycling Information ...7-12 Recycling Assistance...7-12 Preparation ...7-12 Recycling of Disposable Electrodes ...7-12 Packaging ...7-12 Warranty...7-13 Accessories, Supplies, and Training Tools ...7-13

8 Setup Options Setup Options ...8-2 Print Configurations Before Service or Repair...8-2 Passcode Security ...8-2 Entering Setup Options ...8-3 General Setup Menu ...8-4 Manual Mode Setup Menu ...8-5 AED Mode Setup Menu ...8-7 CPR Metronome Setup Menu ...8-8 Pacing Setup Menu...8-9 Monitoring Menu ...8-9 Channels Setup Menu ...8-9 Waveform Sets Setup Menu...8-10 CO2 Setup Menu ...8-10 Events Setup Menu...8-10 Alarms Setup Menu...8-11 Printer Setup Menu ...8-11 Auto Print Setup Menu...8-12 Clock Setup Menu...8-12 Reset Defaults Setup Menu ...8-13 Print Defaults...8-13 Send Configuration Setup Menu ...8-13 Set Passcodes Setup Menu...8-14 Service Mode ...8-14

A Specifications and Performance Characteristics B Defibrillation Clinical Summaries Defibrillation of Ventricular Fibrillation and Ventricular Tachycardia ... B-1 External Cardioversion of Atrial Fibrillation ... B-3 Intra-Operative Ventricular Defibrillation ... B-7 Monophasic vs. Biphasic Waveforms: Out-of-Hospital Trial ... B-10

C Screen Messages D Operator’s Checklist E Shock Advisory System F SpO2 Specifications and Validation G About cprMAX Technology H Docking Station

LIFEPAK 20e Defibrillator/Monitor Operating Instructions

I Electromagnetic Compatibility Guidance Index

vii

Preface

PREFACE

About Automated External Defibrillation About Defibrillation Therapy About Noninvasive Pacing About SpO2 Monitoring About ECG Monitoring About EtCO2 Monitoring

page x xi xii xii xii xiii

Preface

ABOUT AUTOMATED EXTERNAL DEFIBRILLATION The following considerations and guidelines apply when using the LIFEPAK® 20e defibrillator/monitor as an automated external defibrillator (AED).

Operator Considerations The LIFEPAK 20e defibrillator/monitor, when in AED mode, is a semiautomatic defibrillator that uses a patented Shock Advisory System™. This software algorithm analyzes the patient’s electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The LIFEPAK 20e defibrillator/monitor in AED mode requires operator interaction to defibrillate the patient. The LIFEPAK 20e defibrillator/monitor in AED mode is intended for use by personnel who are authorized by a physician/medical director and have, at a minimum, the following skills and training: • CPR training. • AED training equivalent to that recommended by the American Heart Association. • Training in the use of the LIFEPAK 20e defibrillator/monitor in AED mode. For information about training options, contact your local Physio-Control representative.

Indications The AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient’s ECG rhythm. In AED mode, the LIFEPAK 20e defibrillator/monitor is not intended for use on pediatric patients less than 8 years old.

Contraindications None known.

LIFEPAK 20e Defibrillator/Monitor Operating Instructions

Preface

ABOUT DEFIBRILLATION THERAPY Operator Considerations A direct current defibrillator applies a brief, intense pulse of electricity to the heart muscle. The LIFEPAK 20e defibrillator/monitor delivers this energy through disposable electrodes, standard paddles or internal paddles applied to the patient’s chest. Defibrillation is only one aspect of the medical care required to resuscitate a patient with a shockable ECG rhythm. Depending on the situation, other supportive measures may include: • Cardiopulmonary resuscitation (CPR) • Administration of supplemental oxygen • Drug therapy Successful resuscitation is related to the length of time between the onset of a heart rhythm that does not circulate blood (ventricular fibrillation, pulseless ventricular tachycardia) and defibrillation. The American Heart Association has identified the following as critical links in the chain of survival from cardiac arrest: • Early access • Early CPR by first responders or bystanders • Early defibrillation • Early advanced life support The physiological state of the patient may affect the likelihood of successful defibrillation. Thus, failure to resuscitate a patient is not a reliable indicator of defibrillator performance. Patients will often exhibit a muscular response (such as jumping or twitching) during an energy transfer. The absence of such a response is not a reliable indicator of actual energy delivery or device performance.

Indications Defibrillation is a recognized means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia and, in relatively stable patients, ventricular tachycardia.

Contraindications Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA) such as idioventricular or ventricular escape rhythms, and in the treatment of asystole.

Preface

ABOUT NONINVASIVE PACING A noninvasive pacemaker is a device that delivers an electrical stimulus to the heart, causing cardiac depolarization and myocardial contraction. The energy is delivered through large adhesive electrodes placed on the chest. In addition to noninvasive pacing, other supportive measures may be necessary. Among other factors, it is recognized that successful pacing of a patient is related to the length of time between the onset of a dysrhythmia and the initiation of pacing. Rapid pacing and prompt follow-up care are essential. The physiologic state of the patient may affect the likelihood of successful pacing or of skeletal muscle activity. The failure to successfully pace a patient is not a reliable indicator of pacemaker performance. Similarly, the patient’s muscular response to pacing is not a reliable indicator of energy delivered. Refer to the booklet, Noninvasive Pacing: What You Should Know for further information.

Indications Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse.

Contraindications Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole.

ABOUT SPO2 MONITORING A pulse oximeter is a noninvasive device that checks the saturation of oxygen in arterial blood (SpO2). It uses an optical sensor that directs light through the patient’s finger and then measures the received light with a detector. This received light is translated into a saturation percentage and is displayed as an SpO2 reading.

Indications A pulse oximeter is indicated for use in any patient who is at risk of developing hypoxemia.

Contraindications None known.

ABOUT ECG MONITORING The ECG (electrocardiogram) is a recording of the electrical activity of the heart. ECG monitoring allows for identification and interpretation of cardiac rhythms or dysrhythmias and calculation of heart rate. The ECG is obtained by placing either electrodes or paddles on the patient and allows the heart’s electrical activity to be monitored and recorded.

xii

LIFEPAK 20e Defibrillator/Monitor Operating Instructions

Preface

ABOUT ETCO2 MONITORING The end-tidal carbon dioxide (EtCO2) monitor is a capnograph device that uses non-dispersive infrared spectroscopy to continuously measure the amount of CO2 during each breath and report the amount present at the end of exhalation (EtCO2). The sample is obtained by the side stream method and can be used with intubated or nonintubated patients. Respiration rate is also measured and displayed in breaths per minute. The EtCO2 monitor is a tool to be used in addition to patient assessment. Care should be taken to assess the patient at all times; do not rely solely on the EtCO2 monitor.

Indications EtCO2 monitoring is used to detect the level of expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully.

Contraindications None known.

xiii

SAFETY INFORMATION 1 Safety Information

This section provides important information to help you operate the LIFEPAK 20e defibrillator/ monitor. Familiarize yourself with all of these terms, warnings, and symbols. Terms General Warnings and Cautions Symbols

page 1-2 1-2 1-5

1-1

Safety Information

TERMS The following terms are used either in these operating instructions or on the LIFEPAK 20e defibrillator/ monitor: 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 WARNINGS AND CAUTIONS The following are general warning and caution statements. Other specific warnings and cautions are provided as needed in other sections of these operating instructions. WARNINGS! Shock hazard. The defibrillator delivers up to 360 J 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. Shock hazard. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. 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 or explosion. Do not use this device in the presence of flammable gases or anesthetics. 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 could emit strong electromagnetic or radio frequency disturbances that could cause electromagnetic interference (EMI) and affect the performance of this defibrillator. EMI may result in improper defibrillator operation, distorted ECG, failure to detect a shockable rhythm, or cessation of pacing. Avoid operating the defibrillator near cauterizers, diathermy equipment, cellular phones, metal detectors, or electronic articles surveillance gates. Do not rapidly key EMS radios on and off. Refer to the Recommended Separation Distances table (on page I-4) for recommended distances of equipment. Contact a technical support representative if assistance is required.

1-2

LIFEPAK 20e Defibrillator/Monitor Operating Instructions

Safety Information

WARNINGS! (CONTINUED) 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 Recommended Separation Distances table (on page I-4) to any part of the LIFEPAK 20e defibrillator, including cables specified by Physio-Control. Shorter distances may result in compromised performance. Possible electrical interference. Using cables, electrodes, or accessories not specified for use with this device may result in increased emissions or decreased resistance to electromagnetic interference which could affect the performance of this device or of equipment in close proximity. Use only parts and accessories specified in these operating instructions. Possible electrical interference.

1 Safety Information

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 defibrillator in an emergency situation, if possible. Possible electrical interference. The 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 defibrillator shutdown. When operating on battery power, adhere to battery maintenance and replacement intervals discussed in the Battery Performance and Life section to prevent possible defibrillator shutdown. If the defibrillator shuts down without warning, or if a LOW BATTERY: CONNECT TO AC POWER message appears on the monitor screen, immediately connect the AC power cord to an outlet. Possible device failure. Do not modify the defibrillator or CodeManagement Module. 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 defibrillator performance. Changing factory default settings will change the behavior of the device. Changes to the default settings must only be made by authorized personnel. Possible improper defibrillator performance. Using other manufacturers’ cables, electrodes, or batteries may cause the device to perform improperly and invalidates the safety agency certification. Use only the accessories specified in these operating instructions. Possible failure to detect an out of range condition. Reselecting QUICK SET will reset the alarm limits around the patient’s current vital sign values. This may be outside the safe range for the patient.

1-3

Safety Information

WARNINGS! (CONTINUED) 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 or sensors when using high frequency (HF) electrosurgical equipment.

1-4

LIFEPAK 20e Defibrillator/Monitor Operating Instructions

Safety Information

SYMBOLS The symbols below may be found in these operating instructions or on various configurations of LIFEPAK 20e defibrillator/monitor and accessories.

Defibrillation-proof type CF applied part Defibrillation-proof type BF applied part Operating instructions

1 Safety Information

Follow instructions for use. (Symbol has blue background and graphical symbol is white.) Caution General warning. (Symbol has yellow background and graphical symbol is black.) Warning, high voltage Type BF applied part Static sensitive device (SSD) MR unsafe: keep away from magnetic resonance imaging (MRI) equipment Protective earth (ground) Fuse Equipotential connector Positive terminal Negative terminal Use by date shown: yyyy-mm-dd Reorder number (on serial number label*)

Date of manufacture shown: YYYY-MM-DD (on serial number label*)

1-5

Safety Information

Do not reuse Indoor use only Alarm on Alarm off VF/VT alarm on VF/VT alarm silenced Greater than Less than

Joules

Adult defibrillation paddle

Infant defibrillation paddle

Home screen button

Battery status indicator (refer to page 2-23) Heart rate/pulse rate indicator

(x)

Shock count (x) on screen Direct current voltage Alternating current voltage (on serial number label*) On (power: connection to the AC Mains) Off (power: disconnection from the AC Mains)

1-6

LIFEPAK 20e Defibrillator/Monitor Operating Instructions

Safety Information

Power on/off

AC power indicator (CodeManagement Module only) [signal] Input [signal] Output CO2 Input

1 Safety Information

CO2 Exhaust This end up Fragile. Handle with care.

Keep dry Recommended storage temperature 5° to 45°C (41° to 113°F). Storage at extreme temperatures of -20° or 60°C (-4° or 140°F) is limited to seven days. If storage at these temperatures exceeds one week, the electrode shelf-life is reduced. Recommended storage temperature range 5° to 45°C (41° to 113°F).

Recommended shipping temperature range -20° to 60°C (-4° to 140°F).

Relative humidity range 5% to 95%.

Recycle this item Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See www.physio-control.com/recycling for instructions on disposing of this product. (Symbol appears on serial number label.*) Symbol for China RoHS indicating the Environmentally Friendly Use Period (EFUP) denoting the number of years before any substance is likely to leak out into the environment. (Symbol appears on serial number label.*) System connector/Data in

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LIFEPAK 20e Defibrillator Monitor Operating Instructions