LIFEPAK 20 Operating Instructions Aug 2010

LIFEPAK 20 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. The address to which this particular device was shipped is now listed as the current tracking location. 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 either 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.

Responsibility for Information It is the responsibility of our customers to ensure that the appropriate person(s) within their organization have access to this information, including general safety information provided in Section 1.

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.

Version History These operating instructions describe LIFEPAK 20 defibrillator/monitor devices with Operating Software Version 3202609-064 or later.

LIFEPAK, FAST-PATCH, DERMA JEL, QUIK-LOOK, QUIK-COMBO, and LIFE•PATCH are registered trademarks of Physio-Control, Inc. ADAPTIV, CODE-STAT, CODE SUMMARY, REDI-PAK, and Shock Advisory System are trademarks of Physio-Control, Inc. Masimo and LNOP are registered trademarks of Masimo Corporation. EDGE System is a trademark of Ludlow Technical Products. Microsoft and Windows are registered trademarks of Microsoft Corporation. Specifications are subject to change without notice. ©2002-2010 Physio-Control, Inc. All rights reserved.

Publication Date: 08/2010

MIN 3200750-018

TABLE OF CONTENTS

Preface About Automated External Defibrillation... viii About Defibrillation Therapy ... viii About Noninvasive Pacing ... ix About SpO2 Monitoring ... x About ECG Monitoring ... x

1 Safety Information Terms ... 1-2 General Warnings and Cautions ... 1-2 Symbols... 1-3

2 Basic Orientation Introduction... 2-2 Unpacking and Inspecting ... 2-2 Controls, Indicators, and Connectors ... 2-2 Area 3... 2-5 Area 4... 2-7 Area 6... 2-9 Changing Printer Paper... 2-10 Back View ... 2-12 Entering Patient Data ... 2-13 Setting Alarms ... 2-14 Managing Alarms ... 2-15 Connecting to Power ... 2-16 AC Operation ... 2-16 Battery Operation ... 2-16 Battery Performance and Life ... 2-17

3 Monitoring Monitoring the ECG... 3-2

LIFEPAK 20 Defibrillator/Monitor Operating Instructions ©2002–2010 Physio-Control, Inc.

iii

ECG Monitoring Warning ...3-2 Selecting ECG Lead and Size ...3-2 Adjusting the Systole Tone Volume ...3-3 Monitoring ECG with Paddles Accessories ...3-4 Monitoring with the Patient ECG Cable ...3-5 Troubleshooting Tips for ECG Monitoring ...3-7 Monitoring SpO2...3-8 SpO2 Warnings and Cautions ...3-8 When to Use a Pulse Oximeter ...3-9 How a Pulse Oximeter Works...3-10 SpO2 Monitoring Considerations ...3-10 SpO2 Monitoring Procedure ...3-11 SpO2 Waveform ...3-11 SpO2 Volume ...3-12 Sensitivity ...3-12 Averaging Time ...3-12 Pulse Oximeter Sensors...3-12 No Implied License ...3-12 Cleaning ...3-12 Troubleshooting Tips for SpO2 ...3-13

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 ...4-12 Switching from AED to Manual Mode...4-13 Manual Defibrillation ...4-14 Manual Defibrillation Warnings...4-14 Impedance...4-15 Defibrillation Procedure ...4-15 Synchronized Cardioversion Procedure ...4-16 Remote Synchronization Procedure...4-17 Pediatric Defibrillation ...4-18 Pediatric Paddle Placement ...4-18 Defibrillation Procedure ...4-19 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion ...4-19 Noninvasive Pacing ...4-21 Noninvasive Pacing Warnings...4-21 Demand and Nondemand Pacing ...4-22 Noninvasive Pacing Procedure ...4-22 Troubleshooting Tips for Noninvasive Pacing ...4-23

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 ...5-5

iv

LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Testing...5-6 Cleaning and Sterilizing...5-6 Standard Paddle Set (Optional)...5-6 About the Standard Paddle Set ...5-7 Accessing the Pediatric Paddles ...5-7 Replacing the Adult Paddle Attachment ...5-7 Cleaning the Standard Paddle Set ...5-8 Internal Handles with Discharge Control (MIN 3010901) ...5-9 About Internal Handles with Discharge Control...5-9 Inserting the Paddles...5-10 Removing the Paddles ...5-10 Internal Defibrillation Procedure ...5-10 Internal Paddles Synchronized Cardioversion Procedure ...5-10 Handling Internal Paddles ...5-11 Cleaning and Sterilizing...5-11 Testing...5-11

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 ...6-6 Entering Archives Mode ...6-6 Printing Archived Patient Reports...6-7 Editing Archived Patient Records ...6-8 Deleting Archived Patient Records ...6-9 Overview of Connections for Transmitting Reports ...6-10

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 Patient ECG Cable Check ...7-5 General Troubleshooting Tips ...7-10 Service and Repair ...7-11 Product Recycling Information...7-12 Recycling Assistance ...7-12 Preparation ...7-12 Recycling of Disposable Electrodes ...7-12 Packaging...7-12 Warranty ...7-12 Accessories, Supplies, and Training Tools ...7-12

8 Defining Setup Options Setup Options ...8-2 Print Configurations Before Service or Repair...8-2 Passcode Security...8-2 Entering Setup Options ...8-3

LIFEPAK 20 Defibrillator/Monitor Operating Instructions ©2002–2010 Physio-Control, Inc.

v

General Setup Menu ...8-3 Manual Mode Setup Menu ...8-4 AED Mode Setup Menu ...8-5 Pacing Setup Menu ...8-7 Monitoring Menu ...8-8 Channels Setup Menu ...8-8 Waveform Sets Setup Menu ...8-8 Events Setup Menu ...8-9 Alarms Setup Menu ...8-9 Printer Setup Menu...8-9 Auto Print Setup Menu ...8-10 Clock Setup Menu ...8-10 Reset Defaults Setup Menu...8-11 Print Defaults ...8-11 Send Configuration Setup Menu ...8-11 Set Passcode Setup Menu ...8-12 Service Mode...8-12

A Specifications and Performance Characteristics B Clinical Summaries C Screen Messages D Operator’s Checklist E Shock Advisory System F About cprMAX Technology G Docking Station H Electromagnetic Compatibility Guidance Index

vi

LIFEPAK 20 Defibrillator/Monitor Operating Instructions

PREFACE

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

LIFEPAK 20 Defibrillator/Monitor Operating Instructions ©2002–2010 Physio-Control, Inc.

page viii viii ix x x

vii

Preface

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

Operator Considerations The LIFEPAK 20 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 20 defibrillator/monitor in AED mode requires operator interaction to defibrillate the patient. The LIFEPAK 20 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 20 defibrillator/monitor in AED mode.

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 20 defibrillator/monitor is not intended for use on pediatric patients less than 8 years old.

Contraindications None known.

ABOUT DEFIBRILLATION THERAPY Operator Considerations A direct current defibrillator applies a brief, intense pulse of electricity to the heart muscle. The LIFEPAK 20 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

viii

LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Preface Preface

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. For further information, refer to the booklet, Defibrillation: What You Should Know.

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. The biphasic defibrillation waveform used in this device has only been clinically tested on adults; it has not been tested on pediatric patients.

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.

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.

LIFEPAK 20 Defibrillator/Monitor Operating Instructions ©2002–2010 Physio-Control, Inc.

ix

Preface

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 The 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.

x

LIFEPAK 20 Defibrillator/Monitor Operating Instructions

SAFETY INFORMATION 1 Safety Information

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

LIFEPAK 20 Defibrillator/Monitor Operating Instructions ©2002–2010 Physio-Control, Inc.

page 1-2 1-2 1-3

1-1

Safety Information

TERMS The following terms are used either in these Operating Instructions or on the LIFEPAK 20 defibrillator/ monitor: Danger: Warning: Caution:

Immediate hazards that will result in serious personal injury or death. Hazards or unsafe practices that may result in serious personal injury or death. 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 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 may emit strong electromagnetic or radio frequency interference (RFI) which could affect the performance of this device. RFI may result in improper device operation, distorted ECG, failure to detect a shockable rhythm, or cessation of pacing. Avoid operating the device near cauterizers, diathermy equipment, cellular phones, or other portable and mobile RF communications equipment. Maintain equipment separation of at least 1.2 m (4 ft) and do not rapidly key EMS radios on and off. Contact a technical support representative if assistance is required. 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.

1-2

LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Safety Information

WARNINGS! 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 defibrillator in an emergency situation, if possible. Possible defibrillator shutdown.

When operating on battery power, the large current draw required for defibrillator changing may cause the defibrillator to reach shutdown voltage levels with no low battery warning. 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 improper device performance.

1 Safety Information

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 device 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. Safety risk and possible equipment damage.

Monitors, defibrillators, and their accessories (including electrodes and cables) contain ferromagnetic materials. As with all ferromagnetic equipment, these products must not be used in the presence of the high magnetic field created by a Magnetic Resonance Imaging (MRI) device. The high magnetic field created by an MRI device will attract the equipment with a force sufficient to cause death or serious personal injury to persons between the equipment and the MRI device. This magnetic attraction may also damage the equipment and affect the performance of the equipment. Skin burns will also occur due to heating of electrically conductive materials such as patient leads and pulse oximeter sensors. Consult the MRI manufacturer for more information.

SYMBOLS The symbols below may be found in these operating instructions or on various configurations of LIFEPAK 20 defibrillator/monitor and accessories: Defibrillation-proof type CF terminal

Defibrillation protected, type BF patient connection

Attention, consult accompanying documents Warning, high voltage

LIFEPAK 20 Defibrillator/Monitor Operating Instructions ©2002–2010 Physio-Control, Inc.

1-3

Safety Information

Type BF patient connection

Static sensitive device (SSD) Safety ground. Protective earth connection Fuse

Equipotential connector Positive terminal Negative terminal

LOT YYWW

Lot number (batch code) Use by date shown: yyyy-mm-dd

REF YYYY

Reorder number Date of manufacture

Manufacturer

Authorized European Community Representative

Single use only

Indoor use only

Alarm on

Alarm off

VF/VT alarm on

VF/VT alarm silenced

Greater than

1-4

LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Safety Information

Less than

J

Joules

Contrast

Adult defibrillation paddle

Infant defibrillation paddle 1 Safety Information

Home screen button

Heart rate/pulse rate indicator

(x) 0123

Shock count (x) on screen Mark of conformity according to the European Medical Device Directive 93/42/EEC. Canadian Standards Association certification for Canada and the United States. Recognized component mark for Canada and the United States

DC voltage AC voltage On (power: connection to the AC mains)

Off (power: disconnection from the AC mains)

Power on/off [signal] Input [signal] Output

LIFEPAK 20 Defibrillator/Monitor Operating Instructions ©2002–2010 Physio-Control, Inc.

1-5

Safety Information

ECG/SYNC connector

This end up Fragile/breakable Handle with care Protect from water

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.

Recycle this item

System connector/Data in LIFEPAK 20 defibrillator/monitor to LIFEPAK 20 defibrillator/monitor cable (Refer to Send Configuration Setup Menu, page 8-11) Turn counterclockwise to unlock

Switch on

Switch off

Pace arrow, noninvasive pacing

Pace arrow, internal pacing

R-wave sense marker

Event marker

Biphasic defibrillation shock

Shock button

1-6

LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Safety Information

!USA

For USA audiences only

CAT

Catalog number used for placing orders

MIN or PN

Manufacturer’s Item Number (Part Number)

SN

Serial Number

IPX1

Protected from dripping water per IEC 60529 Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See http:// recycling.medtronic.com for instructions on disposing of this product. Federal law restricts this device to sale by or on the order of a physician

LIFEPAK 20 Defibrillator/Monitor Operating Instructions ©2002–2010 Physio-Control, Inc.

1 Safety Information

Rx Only

1-7

BASIC ORIENTATION

This section provides a basic orientation to the LIFEPAK 20 defibrillator/monitor.

LIFEPAK 20 Defibrillator/Monitor Operating Instructions ©2002–2010 Physio-Control, Inc.

page 2-2 2-2 2-2 2-13 2-14 2-15 2-16

2 Basic Orientation

Introduction Unpacking and Inspecting Controls, Indicators, and Connectors Entering Patient Data Setting Alarms Managing Alarms Connecting to Power

2-1

Basic Orientation

INTRODUCTION The LIFEPAK 20 defibrillator/monitor is an acute cardiac care response system used by authorized healthcare providers in hospital and clinic settings. The LIFEPAK 20 defibrillator/monitor offers the following optional features: •

Semiautomatic defibrillator

•

Noninvasive pacemaker

•

Pulse oximeter

•

Paddle accessories

Note: These operating instructions include information and procedures related to all features of the LIFEPAK 20 defibrillator/monitor. Your LIFEPAK 20 defibrillator/monitor may not have all of these features. For more information, contact your Physio-Control representative or call the number listed on the back cover of these operating instructions. The LIFEPAK 20 defibrillator/monitor is available only with the biphasic defibrillation waveform. For a description of the defibrillation waveform, refer to Appendix A. The LIFEPAK 20 defibrillator/monitor uses QUIK-COMBO™ pacing/defibrillation/ECG electrodes or FAST-PATCH® disposable defibrillation/ECG electrodes for ECG monitoring and patient therapy. The therapy cable connects the QUIK-COMBO or FAST-PATCH electrodes to the defibrillator. For more information about QUIK-COMBO or FAST-PATCH electrodes, refer to Section 3 of these operating instructions. The standard paddle set is an accessory for the LIFEPAK 20 defibrillator/monitor and includes adult and pediatric defibrillator (hard) paddles. The standard paddles can be used for QUIK-LOOK® ECG monitoring, defibrillation, and synchronized cardioversion therapies. When using standard paddles, a conductive interface designed for defibrillation, such as defibrillation gel or gel pads, must be used between the paddle electrode surface and the skin. The adult standard paddles can be used for any pediatric patient weighing approximately 10 kg (22 lb) or more as long as the paddles fit completely on the chest and there is at least 2.5 cm (1 in.) of space between the paddle electrodes. Pediatric paddles should be used for patients weighing 10 kg (22 lb) or less or those whose chests are too small to accommodate the adult paddles. Optional internal paddles are also available. For more information about using paddle accessories, refer to Section 5 of these operating instructions.

UNPACKING AND INSPECTING After you have removed the LIFEPAK 20 defibrillator/monitor from the shipping container, make sure you have all the required supplies and accessories including cables and ECG paper. Examine the defibrillator and all accessories for any sign of damage that may have occurred during shipping. If possible, save the shipping container and foam inserts in case you have to ship the defibrillator at a later date.

CONTROLS, INDICATORS, AND CONNECTORS The following figures provide a brief description of the controls, indicators, and connectors for the LIFEPAK 20 defibrillator/monitor. Figure 2-1 shows the front view of the LIFEPAK 20 defibrillator/ monitor and Figure 2-2 shows the front view divided into six areas. Figure 2-3 through Figure 2-12 show details of each area. Figure 2-13 shows the back view of the defibrillator. Additional information about areas 3, 4, and 6 follow the applicable figures. The light emitting diode (LED) in a function button is on when the corresponding function is active. For example, the ANALYZE button LED is on when the

2-2

LIFEPAK 20 Defibrillator/Monitor Operating Instructions