Physio Control Lifepak 20 User manual

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LIFEPAK20

OPERATING INSTRUCTIONS

DEFIBRILLATOR / MONITOR

LIFEPAK20

OPERATING INSTRUCTIONS

DEFIBRILLA TOR/ MONITOR

Important Information

!USA

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.

MIN

3200750-018

Publication Date: 08/2010

Rx Only

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

Text Conventions

Throughout these operating instructions, special text characters are used to indicate labels, screen

messages, and voice prompts:

Section 1.

• 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.

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 iii

Monitoring SpO2..........................................................................................................................3-8

4 Therapy

General Therapy Warnings and Cautions ...................................................................................4-2

Therapy Electrode and Standard Paddle Placement...................................................................4-3

Automated External Defibrillation ................................................................................................4-5

Manual Defibrillation ..................................................................................................................4-14

Pediatric Defibrillation................................................................................................................4-18

Noninvasive Pacing ...................................................................................................................4-21

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

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

Anterior-lateral Placement ....................................................................................................4-3

Anterior-posterior Placement................................................................................................4-3

Special Placement Situations...............................................................................................4-4

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 Warnings...........................................................................................4-14

Impedance..........................................................................................................................4-15

Defibrillation Procedure ......................................................................................................4-15

Synchronized Cardioversion Procedure .............................................................................4-16

Remote Synchronization Procedure...................................................................................4-17

Pediatric Paddle Placement ...............................................................................................4-18

Defibrillation Procedure ......................................................................................................4-19

Troubleshooting Tips for Defibrillation and Synchronized Cardioversion ...........................4-19

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

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 page viii About Defibrillation Therapy viii About Noninvasive Pacing ix About SpO2 Monitoring x About ECG Monitoring x

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 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 (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.

™

. This software algorithm analyzes the patient’s electrocardiographic

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

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.

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.

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 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

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

Te r ms page 1-2 General Warnings and Cautions 1-2 Symbols 1-3

1 Safety Information

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 1-1

Safety Information

TERMS

The following terms are used either in these Operating Instructions or on the LIFEPAK 20 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 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.

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.

1 Safety Information

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 1-3

Safety Information

LOT

YYWW

YYYY

Type BF patient connection

Static sensitive device (SSD)

Safety ground. Protective earth connection

Fuse

Equipotential connector

Positive terminal

Negative terminal

Lot number (batch code)

REF

Use by date shown: yyyy-mm-dd

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

Less than

(x)

0123

Joules

Contrast

Adult defibrillation paddle

Safety Information

Infant defibrillation paddle

Home screen button

Heart rate/pulse rate indicator

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

1 Safety Information

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 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

For USA audiences only

!USA

Safety Information

CAT

MIN or PN

IPX1

Rx Only

Catalog number used for placing orders

Manufacturer’s Item Number (Part Number)

Serial Number

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

1 Safety Information

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 1-7

BASIC ORIENTATION

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

Introduction page 2-2 Unpacking and Inspecting 2-2 Controls, Indicators, and Connectors 2-2 Entering Patient Data 2-13 Setting Alarms 2-14 Managing Alarms 2-15 Connecting to Power 2-16

2 Basic Orientation

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 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 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 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.

pacing/defibrillation/ECG electrodes or

ECG

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

2-2 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

ANALYZE button LED is on when the

advisory function is active.

Area 6

Area 5

Area 4

Area 3

Area 1

Area 2

Recommended

Adult VF Dose XXX-XXX-XXXJ

Basic Orientation

Figure 2-1 Front View with Door

The door on the LIFEPAK 20 defibrillator/monitor hides the manual defibrillation and noninvasive pacing buttons. When the door is closed, the appearance and operation of the device is simplified for the automated external defibrillator (AED) user.

To enter manual mode, press the

MANUAL button located on the lower left corner of the door. This

opens the door and automatically takes the device out of AED mode and allows access to manual mode defibrillation and pacing. After entering manual mode, closing the door does not affect operation.

2 Basic Orientation

Figure 2-2 Front View without Door

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 2-3

Basic Orientation

AED MODE

LED illuminates when

AED mode is active.

Refer to page 4-5.

ANALYZE

Activates Shock Advisory

System (SAS).

Refer to page 4-7.

Switches power on or off.

SHOCK

Discharges defibrillator energy to the patient. Refer to page 4-15.

CHARGE

Charges the defibrillator in manual mode. Refer to page 4-13.

ENERGY SELECT

Selects energy levels in manual mode. Refer to page 4-13.

SYNC

Activates sychronized mode. Refer to page 4-16.

Area 1

Adult VF Dose: xxx-xxx-xxxJ

Recommended

Adult Ventricular Fibrillation Energy Label

Refer to page F-1

RATE

Selects pacing rate. Refer to page 4-21.

CURRENT

Adjusts pacing current.

Refer to page 4-21.

PAUSE

Temporarily slows pacing rate. Refer to page 4-21.

PACER

Activates the pacing function.

Refer to page 4-21.

Area 2

Figure 2-3 Area 1

Figure 2-4 Area 2

2-4 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Basic Orientation

HOME SCREEN

Returns immediately

to Home Screen.

Refer to page 2-5.

CONTRAST

Adjusts screen

contrast.

Refer to page 2-5.

OPTIONS

Accesses optional functions. Refer to page 2-6.

EVENT

Activates user-defined

events.

Refer to page 2-5.

LED

Illuminates when the Speed Dial is active. Refer to page 2-7.

LEAD

Changes ECG lead.

Refer to page 3-2.

SIZE

Changes ECG size. Refer to page 3-2.

ALARMS

Activates and silences alarms. Refer to page 2-14.

Area 3

Figure 2-5 Area 3

Area 3

The following paragraphs provide additional information about the controls shown in Area 3, page 2-5.

Contrast (Passive Display Only)

Press the the defibrillator is turned on, the contrast setting defaults to the previously adjusted setting.

Home Screen

The home screen is the background screen that displays during ECG monitoring. Pressing

SCREEN

or during manual defibrillation charging and shocking.

Event

After pressing

CONTRAST button and rotate the Speed Dial to adjust the screen contrast/brightness. When

HOME

returns you to the home screen from any menu screen or overlay, except during AED analysis

EVENT, the screen displays the following overlay.

Use the Speed Dial to scroll through and select menu choices.

2 Basic Orientation

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 2-5

Basic Orientation

PACING

Selects demand or

nondemand pacing.

Selects internal pacer

detection on/off.

PATIENT

Enters patient name,

patient ID, location, age,

and sex.

DATE/TIME

Sets the date and time. For changes to take effect, cycle power.

Area 4

IrDA PORT

Refer to page 6-11

Refer to warning, page 2-12.

Figure 2-7 Area 4

Area 4

The following paragraphs provide additional information about the Speed Dial and the therapy cable connector shown in Area 4.

Speed Dial

The Speed Dial is active when the indicator LED is illuminated. When active, you can rotate the Speed Dial to highlight and select certain areas of the screen and displayed menu items. Pressing the Speed Dial activates the highlighted menu item. Default menu items are highlighted with a gray background; after a menu item is selected, the background is black.

Therapy Cable Connector

WARNING!

Possible equipment damage and inability to deliver therapy.

To protect the therapy cable connector from damage or contamination, keep the therapy cable connected to the defibrillator at all times.

Connecting the Therapy Cable

To connect a therapy cable to the therapy cable connector:

1 Orient the therapy cable so that the arrow is on top with the cable angled to the right (refer to

Figure 2-8).

2 Insert the therapy cable into the therapy cable connector on the defibrillator.

2 Basic Orientation

3 Rotate the locking ring on the therapy cable clockwise until you feel the connector “click.” Pull

gently on the locking ring to check that the cable is locked in place.

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 2-7

Basic Orientation

Locking Ring

Area 5

Starts or stops the printer.

CODE SUMMARY

Prints a CODE SUMMARY critical event record. Refer to page 6-2.

AC MAINS

LED illuminates when AC

power (line power) is

connected and providing

power. Internal battery is

charging.

SERVICE

Indicates that service is required.

Disconnecting the Therapy Cable

To disconnect a therapy cable from the defibrillator:

1 Rotate the locking ring on the therapy cable in the direction of the arrow (counterclockwise) until it

stops (refer to Figure 2-9).

2 Gently pull out the cable.

Note: LIFEPAK 20 defibrillator/monitors with hardwired standard paddles do not have this feature.

Figure 2-8 Therapy Cable Orientation Figure 2-9 Disconnecting the Therapy Cable

Figure 2-10 Area 5

2-8 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Basic Orientation

Area 6

MONITORING AREA

Displays heart rate, time, SpO2,

indicators for VF/VT alarm and selected energy.

Refer to page 2-10.

STATUS MESSAGE AREA

Displays status and alarm messages.

WAVEFORM

CHANNEL

AREA

Displays up to two

waveform channels.

Refer to

page 2-10.

Figure 2-11 Area 6

Area 6

The following paragraphs provide additional information about Area 6.

Monitoring Area—Heart Rate

The LIFEPAK 20 defibrillator/monitor displays a heart rate between 20 and 300 beats per minute (bpm). A heart rate symbol flashes with each beat. If the heart rate is below 20 bpm or pacing is enabled, the screen displays dashes (– – –). Heart rates above 300 bpm do not yield valid systole tones and the displayed heart rate will not be valid. The heart rate indicator is a tool to be used in addition to patient assessment. Care should be taken to assess the patient at all times and not to rely solely on the heart rate displayed.

2 Basic Orientation

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 2-9

Basic Orientation

WARNING!

Failure to detect a change in ECG rhythm.

Heart rate meters may continue to count the internal pacing pulses during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely on heart rate meter alarms. Keep pacemaker patients under close surveillance.

QRS detection is essential for using the digital heart rate display, systole tone, synchronized cardioversion, and noninvasive demand pacing. The QRS detector in the LIFEPAK 20 defibrillator/ monitor selectively detects QRS complexes. It discriminates against most noise, muscle artifact, Twaves, and other spurious signals.

The QRS detect algorithm automatically adjusts itself to the amplitude of the QRS complexes. Changing the gain of the ECG has no effect on QRS detection. For optimum QRS detection performance, use the lead with the greatest QRS amplitude.

Monitoring Area—Pulse Rate. If the ECG is not active, the SpO2 monitor can display pulse rate. The pulse rate source is indicated by

PR (SPO2).

Monitoring Area—SpO2 (pulse oximeter). The oxygen saturation level is shown as a percentage from 50 to 100. Saturation below 50% is shown as <50%. A fluctuating bar graph represents the pulse signal strength.

Waveform Channel Area

Channel 1. This is the top channel. It displays the primary ECG waveform and is always visible when

ECG is displayed.

Channel 2. This is the bottom channel. It can display an additional waveform or a continuation of the

Channel 1 ECG.

Selecting Waveform Channels

The monitor power must be turned on.

1 At the home screen, rotate the Speed Dial

to highlight Channel 1 or 2.

2 Press the Speed Dial. An overlay appears

with the monitoring choices for the selected channel.

3 Rotate and press the Speed Dial to select

monitoring choices for that channel.

Changing Printer Paper

CAUTION!

Possible printer malfunction.

Using other manufacturers’ printer paper may cause the printer to function improperly and/or damage the print head. Use only the printer paper specified in these operating instructions.

2-10 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Basic Orientation

Loading 50 mm Paper (MIN 804700)

The printer is equipped with an out-of-paper sensor to protect the printhead. The sensor automatically turns off the printer if paper runs out or if the printer door is open.

To load the paper:

1 Press the black button to open the printer door.

2 Remove the empty paper roll.

3 Insert the new paper roll, grid facing upward.

4 Pull out a short length of paper.

5 Push the printer door in to close.

Figure 2-12 illustrates the steps for loading 50 mm paper.

Figure 2-12 Printer

2 Basic Orientation

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 2-11

Basic Orientation

ECG/SYNC connector

System connector

Ground (equipotential connector)

AC power connector

ECG/SYNC connector

System connector

Refer to warning, page 2-12

Back View

The following paragraphs provide additional information about the back view (refer to Figure 2-13).

Figure 2-13 Back View

WARNING!

Shock hazard.

If you are monitoring a patient and using the system connector, all equipment connected to the system connector must be battery powered or electrically isolated from AC power according to EN 60601-1. If in doubt, disconnect the patient from the monitor before using the system connector. For more information, contact Physio-Control Technical Support.

System Connector

The system connector allows access to another LIFEPAK 20 defibrillator/monitor, so that setup information can be transferred between devices.

ECG/SYNC Connector

The ECG/SYNC connector provides remote synchronization and real-time ECG output to a third party monitor.

2-12 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Basic Orientation

ENTERING PATIENT DATA

The following paragraphs describe how to enter or edit a patient’s name, identification (ID), age, or sex.

1 Press OPTIONS. 2 Select

To enter or edit a patient’s name or ID:

1 Select LAST NAME, FIRST NAME, or ID.

PATIENT.

LAST NAME is used as an example

(for this procedure).

To enter or edit a patient’s age:

2 Rotate the Speed Dial to scroll through

the alphabet.

3 Press the Speed Dial to select the desired

character. The character appears in the highlighted area.

4 Repeat steps 2 and 3 until the name is

complete.

5 Scroll and select

END to return to the

Options/Patient screen as shown previously.

There are three additional commands:

BACKSPACE – moves highlight bar left

one space

CLEAR – clears all characters in the name

field

SPACE – inserts a blank space

6 To exit, press the

SCREEN

button.

OPTIONS or HOME

1 Select AGE. 2 Rotate the Speed Dial to scroll to the

desired age.

3 Press the Speed Dial.

2 Basic Orientation

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 2-13

Basic Orientation

To enter or edit a patient’s sex:

1 Select SEX. 2 Rotate the Speed Dial to highlight

FEMALE.

MALE or

3 Press the Speed Dial.

SETTING ALARMS

Alarms for the LIFEPAK 20 defibrillator/monitor can be configured to ON or OFF, and are enabled when the monitor is turned on. When the alarms are configured these limits, press the ALARMS button. The limits will appear to the right of the parameter value. To change the limits, select

When the alarms are configured

QUICK SET.

OFF, the ALARMS button must be pressed and QUICK SET selected to

enable alarms.

When you press the

ALARMS button, the following Alarms overlay appears:

ON, predetermined limits are set. To view

1 Select QUICK SET to activate the alarms

for all active parameters. The quick set limits are set automatically based on the patient’s current vital sign values (refer to

Table 2-1). The alarm limits default to the

setting (

WIDE or NARROW) displayed on

the overlay.

2 Select LIMITS to change the alarm limits to

WIDE or NARROW (refer to Table 2-1).

3 Select SUSPEND to turn off the audible

alarm for up to 15 minutes. If an alarm limit is exceeded while the alarm is silenced, the violated parameter flashes, an alarm message appears, but the alarm tone remains silent.

2-14 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Table 2-1 Wide and Narrow Alarm Limits

Parameter Range

Heart Rate (bpm)

<60 -20 +35 -10 +25 30–150 100–250

60–79 -25 +40 -20 +30

Wide Limits

Low High Low High Low High

80–104 -30 +40 -30 +30

105 -35 +45 -25 +25

SpO2 (%)

Numbers are + from patients’ initial value

Numbers are absolute range values

90 -5 +3 -5 +3 50 90–100

<90-5+3-5+3

Basic Orientation

4 Select VF/VT ALARM to turn on continuous

monitoring for ventricular fibrillation and ventricular tachycardia in manual mode.

A symbol appears above the primary ECG when the alarm is on .

Reselect

VF/VT ALARM to turn off this

alarm.

Note: When the VF/VT alarm is on, you are limited to paddles lead or lead II. Refer to Selecting ECG

Lead and Size, page 3-2.

Note: The VF/VT alarm will be suspended when the noninvasive pacemaker is on and when standard paddles are attached and

LEAD

is selected. The alarm is also

PADDLES

suspended when the device is charging or is fully charged.

Narrow Limits

Limits Range

2 Basic Orientation

MANAGING ALARMS

The alarm bell symbol indicates when alarms are on or off . When alarms are on and an alarm limit is exceeded, a tone sounds, the violated parameter flashes, and an alarm message appears.

To manage an alarm:

1 Press

2 Assess the cause of the alarm.

3 Assess the appropriateness of the limits setting (

4 If the patient is unstable, consider silencing the alarm for up to 15 minutes while attending to the

5 Once the patient is stable, reselect QUICK SET if necessary.

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 2-15

ALARMS. This silences the alarm for 2 minutes.

patient. Do not reselect

QUICK SET.

WIDE or NARROW).

Basic Orientation

WARNING!

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.

When alarms are on, you can silence them preemptively for up to 15 minutes.

To silence alarms preemptively:

1 Press

ALARMS.

2 Select

SUSPEND.

3 Select a silence duration of 2, 5, 10, or 15 minutes.

4 The message ALARMS SUSPENDED appears on the bottom of the screen.

CONNECTING TO POWER

The LIFEPAK 20 defibrillator/monitor operates on AC (line) power or its internal battery. You can switch from battery to AC power or AC power to battery while the device is on and in use by plugging in or unplugging the AC power cord.

WARNING!

Possible defibrillator shutdown.

When operating on battery power, the large current draw required for defibrillator charging 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.

AC Operation

When the LIFEPAK 20 defibrillator/monitor operates on AC power, the AC Mains LED illuminates. When the defibrillator is not in use, the battery charge is best maintained if the power cord is connected to an AC outlet and the defibrillator is turned off.

Battery Operation

The internal nickel-metal hydride battery is rechargeable and intended to be used for standby operation. The defibrillator automatically switches to battery power when the power cord is disconnected from an AC outlet or from the defibrillator.

A new, fully charged battery provides approximately 90 360-joule discharges, 70 minutes of pacing, or approximately 120 minutes of continuous monitoring before the defibrillator turns off. When the LOW BATTERY: CONNECT TO AC POWER message appears on the screen, immediately plug the power cord into an AC outlet to continue use and begin recharging the battery. If low battery messages frequently appear, the battery may need to be replaced. Contact Physio-Control Technical Service or qualified service personnel for assistance.

Connect the defibrillator to AC power after each use to recharge the battery. Typically, new fully depleted batteries recharge for 2.5 hours to regain full capacity. Partially depleted batteries recharge for a time period equivalent to the time the defibrillator was in use. For example, if the defibrillator was used one hour, the required recharge time will be approximately one hour.

2-16 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Basic Orientation

New batteries or batteries that have been stored for an extended time should be recharged before they are used. Connect the defibrillator to an AC power outlet for 2.5 hours to bring the battery to full charge.

Battery Performance and Life

Several factors can contribute to the nickel-metal hydride battery’s performance and life cycle, including:

1 The defibrillator’s use for assisting patients (“on time” and shocks).

2 The defibrillator’s use when the battery is at minimum capacity (low battery condition).

3 The battery’s normal self-discharge rate and the energy used by defibrillator self-tests.

To maximize battery performance and life, plug the defibrillator/monitor into an AC outlet to recharge the battery whenever the defibrillator/monitor is not in use. As a reminder, you can set up the LIFEPAK 20 defibrillator/monitor to sound a series of warning beeps, identified as AC LOSS ALERT, whenever the defibrillator is turned off and not plugged into an AC outlet (refer to the General Setup

Menu, page 8-3).

Note: Even when properly maintained, the internal rechargeable nickel-metal hydride battery should be replaced every two years.

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 2-17

2 Basic Orientation

MONITORING

3 Monitoring

This section describes the monitoring features of the LIFEPAK 20 defibrillator/monitor.

Monitoring the ECG page 3-2 Monitoring SpO2 3-8

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 3-1

Monitoring

MONITORING THE ECG

The following subsections describe:

• ECG Monitoring Warning

• Selecting ECG Lead and Size

• Adjusting the Systole Tone Volume

• Monitoring ECG with Paddles Accessories

• Monitoring with the Patient ECG Cable

• Troubleshooting Tips for ECG Monitoring

ECG Monitoring Warning

WARNING!

Possible misinterpretation of ECG data.

The frequency response of the monitor screen is intended only for basic ECG rhythm identification; it does not provide the resolution required for diagnostic and ST segment interpretation. For diagnostic or ST segment interpretation, or to enhance internal pacemaker pulse visibility, attach the ECG cable. Then print the ECG rhythm in diagnostic frequency response (DIAG).

Selecting ECG Lead and Size

There are two methods for selecting or changing the ECG lead. Both methods are available on your LIFEPAK 20 defibrillator/monitor. The leads available depend on the ECG cable (3-wire or 5-wire) connected to the device.

To change the ECG lead using the

Note: If one or more lead sets are preconfigured, the menu will display the lead sets. Refer to

page 8-8 for information about configuring lead sets.

LEAD button:

1 Press the LEAD button. If an ECG lead

appears, the lead automatically changes to paddles. If paddles lead appears, the lead automatically changes to lead II.

2 When the Lead menu appears, press the

LEAD button again or rotate the Speed Dial

to select another lead. The highlighted selection shows the ECG lead.

Note: When the VF/VT alarm is on, you are limited to paddles lead or lead II in Channel 1. Refer to Setting

Alarms, page 2-14.

3-2 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

To select or change the ECG lead using the Speed Dial:

Monitoring

3 Monitoring

1 Highlight and select Channel 1 and then

Lead to obtain the primary ECG lead choices.

2 Change ECG lead by rotating the Speed

Dial. The highlighted selection shows the ECG lead.

3 Repeat steps 1 and 2 to select or change

displayed waveforms for Channel 2.

You can select or change the ECG size by using the

SIZE button or the Speed Dial. If an ECG is in

Channel 2, the size is automatically changed to match the Channel 1 size.

To select or change the ECG size using the

SIZE button:

1 Press the SIZE button. 2 When the Size menu appears, press the

SIZE button again or rotate the Speed Dial.

The highlighted selection shows the current ECG size.

To select or change the ECG size using the Speed Dial:

1 To obtain the primary ECG, highlight and

select Channel 1 and then Size.

2 Change ECG size by rotating the Speed

Dial. The highlighted selection shows the current ECG size.

Adjusting the Systole Tone Volume

To adjust the systole tone volume, highlight and select heart rate (HR) in the monitoring area of the screen.

The following overlay appears:

1 Rotate the Speed Dial to the desired

volume.

2 Press the home screen to exit.

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 3-3

Monitoring

Lateral

FAST-P ATCH

Electrodes

QUIK-COMBO

Electrodes

Standard

Paddles

Lateral

Apex

Sternum

Monitoring ECG with Paddles Accessories

Anterior-lateral Placement

Anterior-lateral placement is the only placement that should be used for ECG monitoring with paddles accessories.

1 Place either the ♥ or

midaxillary line, with the center of the electrode in the midaxillary line, if possible.

Figure 3-1.

+ therapy electrode or the apex paddle lateral to the patient’s left nipple in the

Refer to

Figure 3-1 Anterior-lateral Placement

2 Place the other therapy electrode or sternum paddle on the patient’s upper right torso, lateral to the

sternum and below the clavicle as shown in Figure 3-1.

Special Placement Situations

When placing therapy electrodes or standard paddles, be aware of the special requirements in the following possible situations.

Obese Patients or Patients with Large Breasts

Apply therapy electrodes or standard paddles to a flat area on the chest, if possible. If skin folds or breast tissue prevent good adhesion, it may be necessary to spread skin folds apart to create a flat surface.

Thin Patients

Follow the contour of the ribs and spaces when pressing the therapy electrodes or standard paddles onto the torso. This limits air spaces or gaps under the electrodes and promotes good skin contact.

Patients with Implanted Pacemakers

If possible, place therapy electrodes or standard paddles away from internal pacemaker generator.

Patients with Implanted Defibrillators

Apply therapy electrodes or standard paddles in the anterior-lateral position and treat this patient as any other patient requiring emergency care.

Paddles Monitoring Procedure

To monitor using therapy electrodes or standard paddles:

1 Press

ON. Adjust contrast if necessary.

2 Prepare the patient’s skin:

• Remove excessive chest hair as much as possible. Avoid nicking or cutting the skin. If possible, avoid placing therapy electrodes or standard paddles over broken skin.

• Clean and dry the skin.

• Do not use alcohol, tincture of benzoin, or antiperspirant to prep the skin.

3-4 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Monitoring

5-Wire cable

3-Wire cable

AHA Labels IEC Labels

RA Right Arm R Right LA Left Arm L Left RL* Right Leg N Negative LL Left Leg F Foot C* Chest C Chest

*Note: Not used for 3-wire cable.

LA/LRA/R

LL/FRL/N

C/C

3 Apply the therapy electrodes or standard paddles in the anterior-lateral position.

For therapy electrodes, confirm that the package is sealed and the Use By date has not passed. For standard paddles, apply conductive gel over the entire electrode surface.

4 Connect the disposable therapy electrodes to the therapy cable.

5 Select paddles lead.

Monitoring with the Patient ECG Cable

There are two ECG cables available for ECG monitoring as shown in Figure 3-2: the 3-wire and 5-wire cables.

Connecting the Patient ECG Cable

Connect the cable by inserting the main cable connector into the green electrically isolated ECG connector on the monitor.

3 Monitoring

Figure 3-2 3-wire and 5-wire ECG Cables

ECG Monitoring Procedure

1 Press

ON. Adjust contrast if necessary.

2 Attach the ECG cable to the monitor.

3 Identify the appropriate electrode sites on the patient as shown in Figure 3-3.

Figure 3-3 Electrode Placement for ECG monitoring

4 Prepare the patient’s skin for electrode application:

• Shave excessive hair at electrode site. Avoid locating electrodes over tendons and major muscle masses.

• For oily skin, clean skin with an alcohol pad.

• Dry the site with a brisk rub.

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 3-5

Monitoring

5 Apply ECG electrodes:

• Confirm package is sealed and Use By date has not passed.

• Attach an electrode to each of the lead wires.

• Grasp electrode tab and peel electrode from carrier.

• Inspect electrode gel and ensure the gel is intact (discard electrode if gel is not intact).

• Hold electrode taut with both hands. Apply the electrode flat to the skin. Smooth tape outwardly. Avoid pressing the center of the electrode.

• Secure the trunk cable clasp to the patient’s clothing.

6 Select the lead on the monitor screen.

7 If necessary, adjust ECG size.

8 Press

PRINT to obtain an ECG printout.

ECG Electrode Requirements

Electrode quality is critical for obtaining an undistorted ECG signal. Always check the date code on electrode packages for the Use By date before applying the electrodes to a patient. Do not use electrodes with expired Use By date codes. Disposable electrodes are intended for a single use.

For best ECG monitoring results, use silver/silver chloride (Ag/AgCl) electrodes. The post-defibrillation ECG will display in less time than expected with other types of electrodes.

Leads Off Messages

If an electrode or lead wire disconnects during ECG monitoring, the monitor emits an audible alarm and displays a leads off message. The ECG trace becomes a dashed line

. The alarm and messages

continue until the electrode or lead wire is replaced.

Color Coding for ECG Leads

The lead wires and the electrode snaps for the patient ECG cable are color coded according to AHA or IEC standards as listed in Table 3-1.

Table 3-1 ECG Leads Color Codes

Leads AHA Label AHA Color IEC Label IEC Color

Limb Leads RA White R Red

LA Black L Yellow

RL Green N Black

LL Red F Green

CBrownCBrown

Monitoring Patients with Internal Pacemakers

The LIFEPAK 20 defibrillator/monitor typically does not use internal pacemaker pulses to calculate the heart rate. However, the monitor may detect internal pacemaker pulses as QRS complexes. This may result in an inaccurate heart rate display.

Smaller amplitude internal pacemaker pulses may not be distinguished clearly. For improved detection and visibility of internal pacemaker pulses, turn on the internal pacemaker detector, and/or connect the ECG cable, select an ECG lead, and print the ECG in diagnostic frequency response.

Large amplitude pacemaker pulses may overload the QRS complex detector circuitry so that no paced QRS complexes are counted. To help minimize ECG pickup of large unipolar pacemaker pulses when monitoring patients with internal pacemakers, place ECG electrodes so the line between the positive and negative electrodes is perpendicular to the line between the pacemaker generator and the heart.

3-6 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Monitoring

The LIFEPAK 20 defibrillator/monitor annotates internal pacemaker pulses with a hollow arrow on the display and the printed ECG if this feature is configured or selected

ON. False annotations of this

arrow may occur if ECG artifacts mimic internal pacer pulses. If false annotations occur, you may deactivate the detection feature using the Options/Pacing/Internal Pacer menu (refer to Figure 2-6). Also refer to the Pacing Setup Menu in Tab le 8 - 8. Patient history and other ECG waveform data, such as wide QRS complexes, should be used to verify the presence of an internal pacemaker.

Troubleshooting Tips for ECG Monitoring

If problems occur while monitoring the ECG, check the list of observations in Table 3-2 for aid in troubleshooting. For basic troubleshooting problems such as no power, refer to General

Troubleshooting Tips in Section 7.

Table 3-2 Troubleshooting Tips for ECG Monitoring

Observation Possible Cause Corrective Action

1 Screen blank and ON

LED lighted.

2 Any of these messages

displayed:

CONNECT ELECTRODES CONNECT ECG LEADS ECG LEADS OFF XX LEADS OFF

3 Poor ECG signal quality. Poor electrode-skin contact. • Reposition cable and/or lead wires to

Screen not functioning properly. • Print ECG on recorder as backup.

• Contact service personnel for repair.

Therapy electrodes are not connected.

One or more ECG electrodes are

• Confirm therapy electrode connections.

• Confirm ECG electrode connections.

disconnected.

ECG cable is not connected to

• Confirm ECG cable connections.

monitor.

Poor electrode-to-patient adhesion.

• Reposition cable and/or lead wires to prevent electrodes from pulling away from patient.

• Prepare skin and replace electrode(s).

• Select another lead.

Broken ECG cable lead wire. • Select paddles lead and use standard

paddles or therapy electrodes for ECG monitoring.

• Check ECG cable continuity.

prevent electrodes from pulling away from patient. Secure trunk cable clasp to patient’s clothing.

• Prepare skin and replace electrode(s).

Outdated, corroded, or dried-out electrodes.

• Check date codes on electrode packages.

• Use only silver/silver chloride electrodes with Use By dates that have not passed.

• Leave electrodes in sealed pouch until time of use.

Loose connection. Damaged cable or connector/lead wire.

• Check/reconnect cable connections.

• Inspect ECG and therapy cables.

• Replace if damaged.

• Check cable with simulator and replace if malfunction observed.

Noise because of radio frequency interference (RFI).

• Check for equipment causing RFI (such as a radio transmitter) and relocate or turn off equipment power.

3 Monitoring

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 3-7

Monitoring

Table 3-2 Troubleshooting Tips for ECG Monitoring (Continued)

Observation Possible Cause Corrective Action

4 Baseline wander

(low frequency/high amplitude artifact).

Inadequate skin preparation. Poor electrode-skin contact. Diagnostic frequency response.

• Prepare skin and reapply electrodes.

• Check electrodes for proper adhesion.

• Print ECG in monitor frequency response.

5 Fine baseline artifact

(high frequency/low amplitude).

Inadequate skin preparation. Isometric muscle tension in arms/ legs.

• Prepare skin and reapply electrodes.

• Confirm that limbs are resting on a supportive surface.

• Check electrodes for proper adhesion.

6 Systole beeps not heard

or do not occur with

Volume too low. QRS amplitude too small to detect.

• Adjust volume.

• Change ECG lead.

each QRS complex.

7 Monitor displays dashed

lines with no ECG leads

Paddles lead selected but patient connected to ECG cable.

• Select one of the limb leads.

off messages.

8 Heart rate (HR) display

different than pulse rate.

Monitor is detecting the patient’s internal pacemaker pulses.

• Change ECG lead.

• Change monitor lead to reduce internal pacemaker pulse size.

9 Internal pacemaker

pulses difficult to see.

Pulses from pacemaker are very small. Monitor the visibility of frequency response limits.

• Turn on internal pacemaker detector (refer to page 2-7).

• Connect ECG cable and select ECG lead instead of paddles.

• Print ECG in diagnostic mode (refer to

page 2-7).

MONITORING SpO2

The following paragraphs describe:

• SpO2 Warnings and Cautions

• When to Use a Pulse Oximeter

• How a Pulse Oximeter Works

• SpO2 Monitoring Considerations

• SpO2 Monitoring Procedure

• Pulse Oximeter Sensors

• SpO2 Volume

• Troubleshooting Tips for SpO2

SpO2 Warnings and Cautions

WARNINGS!

Shock or burn hazard.

Before use, carefully read these operating instructions, the sensor and extension cable directions for use, and precautionary information.

Shock or burn hazard.

Other manufacturers’ oxygen transducers may cause improper oximeter performance and invalidate safety agency certification. Use only oxygen transducers approved for this product.

3-8 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Monitoring

WARNINGS!

Inaccurate pulse oximeter readings.

Do not use a damaged extension cable or one with exposed electrical contacts. Never use more than one extension cable between the pulse oximeter and the sensor.

Inaccurate pulse oximeter readings.

Do not use a damaged sensor. Do not alter the sensor in any way. Alterations or modifications may affect performance and/or accuracy.

Inaccurate pulse oximeter readings.

Sensors exposed to ambient light when incorrectly applied to a patient may exhibit inaccurate saturation readings. Securely place the sensor on the patient and check the sensor’s application frequently to help ensure accurate readings.

Inaccurate pulse oximeter readings.

Severe anemia, significant blood levels of carboxyhemoglobin or methemoglobin, intravascular dyes that change usual blood pigmentation, excessive patient movement, venous pulsations, electrosurgical interference, exposure to irradiation and placement of the sensor on an extremity that has a blood pressure cuff, intravascular line or externally applied coloring (such as nail polish) may interfere with oximeter performance. The operator should be thoroughly familiar with the operation of the oximeter prior to use.

3 Monitoring

Inaccurate pulse oximeter readings.

The pulsations from intra-aortic balloon support can be additive to the pulse rate. Verify patient’s pulse rate against the ECG heart rate.

Skin injury.

Prolonged, continuous use of a sensor may cause irritation, blistering, or pressure necrosis of the skin. Check the sensor site regularly based on patient condition and type of sensor. Change the sensor site if skin changes occur. Do not use tape to hold the sensor in place, as this may cause inaccurate readings or damage to the sensor or skin.

Possible strangulation.

Carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.

CAUTION!

Possible equipment damage.

To avoid damaging the extension cable or the sensor, hold the connectors, rather than the cables, when disconnecting.

When to Use a Pulse Oximeter

A pulse oximeter is a noninvasive tool that checks the saturation of oxygen in arterial blood (SpO2) and is not to be used as an apnea monitor. It is used for monitoring patients who are at risk of developing hypoxemia. If a pulse oximeter is not used, the only indications of hypoxemia are a patient’s dusky skin, nail beds, and mucous membranes, accompanied by restlessness and confusion. These indications are not conclusive, however, and do not appear until after the patient has developed hypoxemia. Pulse oximetry is to be used in addition to patient assessment. Care should be taken to assess the patient at all times and to not solely rely on the SpO2 reading. If a trend toward patient deoxygenation is indicated, blood samples should be analyzed using laboratory instruments to completely understand the patient’s condition.

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 3-9

Monitoring

Sensor (holds LEDs and

detector)

Red Infrared

Light emitting

diodes

Light receiving

detector

How a Pulse Oximeter Works

A pulse oximeter sensor directs light through a fleshy body site (usually the finger or earlobe). The sensor sends light from the emitting diodes to the receiving detector as shown in Figure 3-4. Oxygen saturated blood absorbs light differently as compared to unsaturated blood. The pulse oximeter translates the amount of light received into a saturation percentage and displays an SpO2 reading. Normal values typically range from 95% to 100% at sea level.

Figure 3-4 How a Pulse Oximeter Works

The quality of the SpO2 reading depends on correct sensor size and placement, adequate blood flow through the sensor site, patient motion, and exposure to ambient light. For example, with very low perfusion at the monitored site, readings may read lower than core arterial oxygen saturation. Test methods for accuracy are available by contacting your local Physio-Control representative.

SpO2 Monitoring Considerations

Each oximeter sensor is applied to a specific site on the patient. Use the following criteria to select the appropriate sensor:

• Patient weight

• Patient perfusion to extremities

• Patient activity level

• Available application sites on the patient’s body

• Sterility requirements

• Anticipated duration of monitoring

To help ensure optimal and accurate performance:

• Use a dry and appropriately sized sensor.

• Keep the sensor site at the same level as the patient’s heart.

• Apply it according to the Directions for Use provided with the sensor.

• Observe all warnings and cautions noted in the sensor’s Directions for Use.

3-10 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Monitoring

The sensors are sensitive to light. If excessive ambient light is present, cover the sensor site with an opaque material to block the light. Failure to do so could result in inaccurate measurements.

If patient movements present a problem, consider the following possible solutions:

• Be sure the sensor is secure and properly aligned.

• Use a new sensor with fresh adhesive backing.

• If possible, move the sensor to a less active site.

Note: Wrapping the sensor too tightly or using supplemental tape to hold the sensor in place may cause inaccurate measurements.

SpO2 Monitoring Procedure

The defibrillator controls power to the pulse oximeter. When the defibrillator is turned on, the oximeter turns on and performs a self-test that requires up to 10 seconds. When the defibrillator is turned off, the oximeter also turns off.

To conserve battery power, the pulse oximeter goes into “sleep mode” when not in use. Sleep mode is activated within 10 seconds of disconnecting the sensor. During sleep mode, the screen does not display SpO2 information. The oximeter returns to normal mode after detecting a sensor or a patient signal. The oximeter performs the self-test when it returns from sleep mode to active mode.

The pulse oximeter measures SpO2 levels between 1% and 100%. When SpO2 levels are between 70% and 100%, oximeter measurements are accurate from ±3 digits. When the pulse oximeter measures SpO2 levels less than 50%, the display shows < 50%.

3 Monitoring

To measure the patient’s SpO2 levels:

1 Connect the SpO2 cable to the monitor.

2 Attach the sensor to the SpO2 cable and the patient.

3 Press

ON.

4 Observe the pulse bar for fluctuation. Amplitude of the pulse bar indicates relative signal strength.

5 Adjust sensitivity, averaging time, and SpO2 volume as necessary.

SpO2 Waveform

The SpO2 waveform can be displayed on waveform Channel 2 by selecting waveform Channel 2 and then selecting SpO2 from the Waveform menu. The SpO2 waveform automatically sizes itself to provide optimum waveform viewing.

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 3-11

Monitoring

SpO2 Volume

To adjust the pulse tone volume, highlight and select SPO2 on the home screen.

The following overlay appears:

1 Highlight and select SPO2 VOLUME. 2 Rotate the Speed Dial to the desired

volume.

3 Press the Speed Dial to set the volume.

Sensitivity

The sensitivity setting allows you to adjust the oximeter for differing perfusion states. To adjust the sensitivity to either normal or high, highlight and select

SENSITIVITY.

The normal sensitivity setting is the recommended setting for most patients. The high sensitivity setting allows for SpO2 monitoring under low perfusion states such as the severe hypotension of shock. However, when the SpO2 sensitivity is set to high, the signal is more susceptible to artifact. It is recommended that the patient be monitored closely when the high sensitivity setting is in use.

SPO2 on the home screen and then select

Averaging Time

The averaging time setting allows you to adjust the time period used to average the SpO2 value. Four time periods are provided for averaging: 4, 8, 12, and 16 seconds. To adjust the averaging time, highlight and select

The averaging time of 8 seconds is recommended for most patients. For patients with rapidly changing SpO2 values, the 4-second time is recommended. The 12 and 16 second periods are used when artifact is affecting the performance of the pulse oximeter.

SPO2 on the home screen and select AVERAGING TIME.

Pulse Oximeter Sensors

Refer to the LIFEPAK 20 Accessories Catalog for the sensors and extension cables to be used with the LIFEPAK 20 defibrillator/monitor. Carefully read the directions for use provided with these sensors and cables for complete descriptions, instructions, warnings, cautions, and specifications. To order sensors and extension cables, contact your local Physio-Control representative

No Implied License

Possession or purchase of this oximeter does not convey any express or implied license to use the oximeter with replacement parts which would, alone or in combination with the oximeter, fall within the scope of one or more of the patents relating to this device.

Cleaning

To clean the sensors, first remove them from the patient and disconnect them from the connector cable. Clean LNC and LNOP DCI sensors by wiping them with a 70% isopropyl alcohol pad. Allow the sensors to dry before placing them on a patient. Do not attempt to sterilize.

3-12 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Monitoring

To clean the connector and adapter cables, first remove them from the defibrillator and then wipe them with a 70% isopropyl alcohol pad. Allow them to dry before reconnecting them to the defibrillator. Do not attempt to sterilize.

Note: Do not soak or immerse the cables in any liquid solution.

Troubleshooting Tips for SpO2

Table 3-3 Troubleshooting Tips for SpO2

Observation Possible Cause Corrective Action

1 The oximeter measures a

pulse, but there is no oxygen saturation or pulse rate.

SpO2 or pulse rate changes

rapidly; pulse amplitude is erratic.

SpO2 value is displayed.

3 No

SPO2: NO SENSOR DETECTED

message appears.

SPO2: CHECK SENSOR

message appears.

Excessive patient motion. • Keep patient still.

• Check that sensor is secure.

• Relocate sensor.

• Replace sensor.

Patient perfusion may be too low. • Check patient.

• Increase sensitivity.

Excessive patient motion. • Keep patient still.

• Check that sensor is secure.

• Relocate sensor.

• Replace sensor.

• Increase sensitivity.

An electrosurgical unit (ESU) may be interfering with performance.

• Move the monitor as far as possible from the ESU.

• Plug the ESU and monitor into different circuits.

• Move the ESU ground pad as close to the surgical site as possible.

• Sensor may be damp, replace it.

• Remove sensor extension cable and connect the sensor directly.

Oximeter may be performing a

• Wait for completion.

self-test (requires 10 seconds).

Sensor is not connected to patient or cable disconnects from device.

Sensor is disconnected from patient or cable.

• Check that sensor and cable are connected properly.

• Attach the sensor.

• Check that sensor is secure.

Excessive ambient light. • Remove or block light source if

possible.

• Cover sensor with opaque material, if necessary.

Patient has a weak pulse or low blood pressure.

• Test sensor on someone else.

• Check if patient perfusion is adequate for sensor location.

• Check if sensor is secure and not too tight.

• Check that sensor is not on extremity with blood pressure cuff or intravascular line.

• Change sensor location.

3 Monitoring

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 3-13

Monitoring

Table 3-3 Troubleshooting Tips for SpO2 (Continued)

Observation Possible Cause Corrective Action

6 SPO2: UNKNOWN SENSOR

message appears.

SPO2: SEARCHING FOR PULSE

message appears.

A sensor is connected to the device that is not a Physio-Control approved sensor.

A sensor is connected to the patient and is searching for a

• Check that the sensor is an approved Physio-Control sensor.

• Wait for completion.

pulse.

SPO2: LOW PERFUSION

Patient has a weak pulse. • Change sensor location.

message appears.

3-14 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

THERAPY

This section describes patient therapy.

General Therapy Warnings and Cautions page 4-2 Therapy Electrode and Standard Paddle Placement 4-3 Automated External Defibrillation 4-5 Manual Defibrillation 4-14 Pediatric Defibrillation 4-18 Noninvasive Pacing 4-21

4Therapy

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 4-1

Therapy

GENERAL THERAPY WARNINGS AND CAUTIONS

WARNINGS!

Shock hazard.

The defibrillator delivers up to 360 J of electrical energy. When discharging the defibrillator, do not touch the paddle electrode surfaces or disposable therapy electrodes.

Shock hazard.

If a person is touching the patient, bed, or any conductive material in contact with the patient during defibrillation, the delivered energy may be partially discharged through that person. Clear everyone away from contact with the patient, bed, and other conductive material before discharging the defibrillator.

Shock hazard.

Do not discharge the defibrillator into the open air. To remove an unwanted charge, change the energy selection, select disarm, or turn off the defibrillator.

Possible fire, burns, and ineffective energy delivery.

Do not discharge standard paddles on top of therapy electrodes or ECG electrodes. Do not allow standard paddles (or therapy electrodes) to touch each other, ECG electrodes, lead wires, dressings, transdermal patches, etc. Such contact can cause electrical arcing and patient skin burns during defibrillation and may divert defibrillating energy away from the heart muscle.

Possible defibrillator shutdown.

When operating on battery power, the large current draw required for defibrillator charging may cause the defibrillator to reach a shutdown voltage level 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 skin burns.

During defibrillation or pacing, air pockets between the skin and therapy electrodes may cause patient skin burns. Apply therapy electrodes so that entire electrode adheres to skin. Do not reposition the electrodes once applied. If the position must be changed, remove and replace with new electrodes.

Possible skin burns and ineffective energy delivery.

Therapy electrodes that are dried out or damaged may cause electrical arcing and patient skin burns during defibrillation. Do not use therapy electrodes that have been removed from foil package for more than 24 hours. Do not use electrodes beyond expiration date. Check that electrode adhesive is intact and undamaged. Replace therapy electrodes after 50 shocks.

Possible interference with implanted electrical device.

Defibrillation may cause implanted devices to malfunction. Place standard paddles or therapy electrodes away from implanted devices if possible. Check implanted device function after defibrillation.

CAUTION!

Possible equipment damage.

Prior to using this defibrillator, disconnect all equipment from the patient that is not defibrillatorprotected.

4-2 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Therapy

FAST-PAT CH

Electrodes

Standard

Paddles

QUIK-COMBO

Electrodes

Lateral

Apex

Sternum

Lateral

THERAPY ELECTRODE AND STANDARD PADDLE PLACEMENT

The following paragraphs describe therapy electrodes and standard paddles placement, including special placement situations.

Anterior-lateral Placement

Anterior-lateral placement allows for ECG monitoring, defibrillation, synchronized cardioversion, and noninvasive pacing.

1 Place either the ♥ or + therapy electrode, or apex paddle lateral to the patient's left nipple in the

midaxillary line, with the center of the electrode in the midaxillary line, if possible. Refer to

Figure 4-1.

4Therapy

Figure 4-1 Anterior-lateral Placement

2 Place the other therapy electrode or sternum paddle on the patient’s upper right torso, lateral to the

sternum, and below the clavicle as shown in Figure 4-1.

Anterior-posterior Placement

Anterior-posterior is an alternative position for noninvasive pacing, manual defibrillation, and synchronized cardioversion, but not for ECG monitoring or automated defibrillation. The ECG signal obtained through electrodes in this position is not a standard lead.

1 Place either the ♥ or + therapy electrode over the left precordium as shown in Figure 4-2. The

upper edge of the electrode should be below the nipple. Avoid placement over the nipple, the diaphragm, or the bony prominence of the sternum if possible.

2 Place the other electrode behind the heart in the infrascapular area as shown in Figure 4-2. For

patient comfort, place the cable connection away from the spine. Do not place the electrode over the bony prominences of the spine or scapula.

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 4-3

Therapy

QUIK-COMBO Electrodes

FAST-PATCH Electrodes

POSTERIOR

Figure 4-2 Anterior-posterior Placement for Noninvasive Pacing or Defibrillation

Special Placement Situations

When placing therapy electrodes or standard paddles, be aware of the special requirements in the following possible situations.

Synchronized Cardioversion

Alternative anterior-posterior placements for cardioversion of supraventricular arrhythmias include:

• Place the ♥ or + therapy electrode over the left precordium and the other electrode on the patient’s right posterior infrascapular area

– or –

• Place the ♥ or + therapy electrode to the right of the sternum and the other electrode on the patient’s posterior left infrascapular area.

Obese Patients or Patients with Large Breasts

Thin Patients

Follow the contour of the ribs and spaces when pressing the therapy electrodes onto the torso. This limits air spaces or gaps under the electrodes and promotes good skin contact.

Patients with Implanted Pacemakers

If possible, place therapy electrodes or standard paddles away from the internal pacemaker generator to help prevent damage to the pacemaker. Treat the patient like any other patient requiring care. When operating the defibrillator in AED mode, pacemaker pulses may prevent advisement of an appropriate shock, regardless of the patient’s underlying rhythm.

Patients with Implanted Defibrillators

Apply therapy electrodes or standard paddles in the anterior-lateral position and treat this patient as any other patient requiring emergency care. If defibrillation is unsuccessful, it may be necessary to try alternate electrode placement (anterior-posterior) due to the insulative properties of implanted defibrillator electrodes.

4-4 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

AUTOMATED EXTERNAL DEFIBRILLATION

The following paragraphs include:

• AED Warnings

• AED Setup

• AED Procedure

• Special AED Setup Options

• Troubleshooting Tips for AED Mode

• Switching from AED to Manual Mode

AED Warnings

Therapy

WARNINGS!

Possible misinterpretation of data.

Do not analyze while patient is moving or being transported. Motion artifact may affect the ECG signal resulting in an inappropriate shock or no shock advised message. Motion detection may delay analysis. Stop motion and stand clear of patient during analysis.

Pediatric patient safety risk.

In AED mode, this defibrillator is not designed to administer energy at pediatric joule settings. The American Heart Association recommends AEDs be used only on patients who are more than eight years old.

AED Setup

You can setup the LIFEPAK 20 defibrillator/monitor to turn on in AED mode before placing the defibrillator in use (refer to Section 8).

When illuminated, the AED mode LED indicates that the Continuous Patient Surveillance System (CPSS) is active. CPSS automatically monitors the patient ECG for a potentially shockable rhythm.

When the analysis system that advises the user if it detects a shockable or nonshockable rhythm.

The LIFEPAK 20 defibrillator/monitor can be setup to display the ECG waveform in AED mode or to not display a waveform. The operation in AED mode remains the same whether or not the ECG waveform is displayed.

ANALYZE button is pressed, the Shock Advisory System (SAS) is activated. SAS is an ECG

When the ECG waveform is set to ON in the setup options (refer to Section 8), the ECG appears with all of the AED messages and prompts, as shown in the screen to the left.

4Therapy

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 4-5

Therapy

When the ECG waveform is set to OFF in the setup options, the messages and prompts fill the screen as shown in the screen to the left.

AED Procedure

The following descriptions of voice prompts and messages are based on the factory default settings for AED mode. The default settings are consistent with 2005 American Heart Association (AHA) and European Resuscitation Council (ERC) guidelines. Changing the setup options may result in different AED behavior. Refer to Section 8 for setup option choices.

1 Verify that the patient is in cardiopulmonary arrest (unresponsive, not breathing normally, and

showing no signs of circulation.

2 Press

3 Prepare the patient for electrode placement (refer to Paddles Monitoring Procedure, page 3-4).

ON.

The CONNECT ELECTRODES message and voice prompt occur until the patient is connected to the AED.

4 Connect the therapy electrodes to the therapy cable, and confirm cable connection to the

defibrillator.

5 Apply the electrodes to the patient's chest in the anterior-lateral position (refer to Anterior-lateral

Placement, page 4-3).

6 Press the

ANALYZE button to initiate analysis. Stop CPR.

The PUSH ANALYZE message and voice prompt occur when the patient is properly connected to the AED. The message will stay on the screen and the analyze LED flashes until

PUSH ANALYZE

ANALYZE is pressed.

4-6 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

7 Follow screen messages and voice prompts provided by the AED.

You will see and hear ANALYZING NOW,

STAND CLEAR

patient or therapy cable during analysis. ECG analysis requires approximately 6 to 9 seconds. The analyze LED illuminates during analysis.

Therapy

. Do not touch or move the

The SAS analyzes the patient's ECG and advises either

Shock Advised

SHOCK ADVISED or NO SHOCK ADVISED.

If the AED detects a shockable ECG rhythm, you will see and hear SHOCK ADVISED. The AED begins charging to the setup joule setting for shock #1. A rising tone indicates that the AED is charging.

When charging is complete, the AED displays the available energy.

You will see and hear STAND CLEAR, PUSH

TO SHOCK

( ) followed by a “shock ready”

tone. The shock LED flashes.

Clear everyone away from the patient, bed, or any equipment connected to the patient.

4Therapy

Press the button to discharge the AED.

Note: If you do not press the button within 60 seconds, the AED disarms the shock button, and the

DISARMING message appears.

When the button is pressed you will see the message

ENERGY DELIVERED indicating

energy transfer was completed.

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 4-7

Therapy

2:00

When energy transfer is complete the shock counter increases by 1. This will continue to increase incrementally with every energy transfer.

No Shock Advised

After a shock is delivered you will see and hear START CPR. A countdown timer (min:sec format) continues for the duration specified in

CPR TIME 1 setup option.

the

When the CPR countdown time ends, you will see and hear message stays on the screen and the voice prompt will repeat every 20 seconds until you press the

If the AED detects a nonshockable rhythm, you will see and hear NO SHOCK ADVISED. The AED will not charge, and a shock can not be delivered.

ANALYZE button.

PUSH ANALYZE. This

After a NO SHOCK ADVISED prompt you will see and hear (min:sec format) continues for the duration specified in the CPR TIME 2 setup option. (Refer to Section 8).

When the CPR countdown time ends, you will see and hear PUSH ANALYZE. This message stays on the screen and the voice prompt will repeat every 20 seconds until you press the

START CPR. A countdown timer

ANALYZE button.

4-8 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Proper Connection

Therapy

If therapy electrodes are not connected to the therapy cable or not placed on the patient’s chest, the CONNECT ELECTRODES message and voice prompt occur until the patient is connected to the AED.

If the therapy cable is not connected to the defibrillator, you will see the

CABLE

message until the cable is

CONNECT

connected.

If the test plug is connected to the therapy cable when analysis is initiated, the REMOVE

TEST PLUG

message and voice prompt

occurs.

4Therapy

After you remove the test plug from the therapy cable, the message and voice prompt

CONNECT ELECTRODES occurs until

the patient is connected to the AED.

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 4-9

Therapy

Motion Detected

Continuous Patient Surveillance System

If the motion is detected during the ECG analysis, you will see and hear MOTION

DETECTED, STOP MOTION

followed by a warning tone. Analysis is inhibited up to 10 seconds. After 10 seconds, even if motion is still present, the analysis proceeds to completion. Refer to Table 4-1 for possible motion causes and suggested solutions.

When the AED is not analyzing the ECG or is in CPR Time, it continuously monitors the ECG for a potentially shockable rhythm (CPSS). If the AED detects a shockable rhythm, you will see and hear

ANALYZE

is off.

PUSH ANALYZE, if AUTO

You should: 1 Confirm the patient is unconscious,

pulseless, and not breathing normally.

2 Confirm no motion is present. Stop CPR. 3 Press

ANALYZE.

The AED begins to analyze the patient’s ECG. For information about changing the defibrillation mode, refer to Section 8.

Special AED Setup Options

The following descriptions of voice prompts and messages explain special cprMAX technology setup options (refer to Appendix F).

Initial CPR - CPR First

When the the AED is turned on.

INITIAL CPR option is set to CPR FIRST, you will be prompted to START CPR immediately after

You will see and hear START CPR.

4-10 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

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2:00

After 3 seconds, a countdown timer continues for the duration specified in the initial CPR period and you will see and hear

IF YOU WITNESSED THE ARREST, PUSH ANALYZE. This provides an opportunity to end

the initial CPR early and proceed to analysis.

• If you did witness the arrest, you should press ANALYZE and proceed directly to analysis. This will end the CPR period and you will see and hear

Note: The decision to end CPR early is based on your hospital protocol.

• If you did not witness the arrest, you should perform CPR and not press countdown timer continues for the duration specified in the example, 90 seconds. When initial CPR time ends, you will see and hear

Initial CPR - Analyze First

When the AED is turned on. CPR is prompted after the AED completes the analysis.

If the electrodes are not attached to the patient, you will see and hear you are prompted to perform analysis.

INITIAL CPR option is set to ANALYZE FIRST, you will be prompted to perform analysis after the

ANALYZING NOW, STAND CLEAR.

ANALYZE. The Initial CPR

INITIAL CPR TIME setup option, for

PUSH ANALYZE.

CONNECT ELECTRODES before

4Therapy

No Shock Advised

If the AED detects a nonshockable rhythm, you will be prompted to START CPR. A countdown timer (min:sec format) continues for the duration specified in the

setup option. (Refer to Section 8).

TIME

When initial CPR time ends, you will see and hear NO SHOCK ADVISED followed by PUSH ANALYZE.

Shock Advised

If the AED detects a shockable rhythm, you will see and hear

YOU WITNESSED THE ARREST, PUSH ANALYZE

end the initial CPR early and proceed directly to delivering a shock.

. This provides an opportunity to

START CPR followed by IF

INITIAL CPR

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 4-11

Therapy

• If you did witness the arrest, you should press ANALYZE and proceed directly to shock. This will end the CPR period and you will see and hear

SHOCK ADVISED and STAND CLEAR, PUSH TO SHOCK ().

Proceed according to your training with the AED for delivering the shock.

Note: The decision to end CPR early is based on your hospital protocol.

• If you did not witness the arrest, you should perform CPR and not press countdown timer continues for the duration specified in the

INITIAL CPR TIME setup option, for

example, 90 seconds. When initial CPR time ends, you will see and hear

ANALYZE. The Initial CPR

SHOCK ADVISED. Proceed

according to your training with the AED for delivering a shock.

Pre-shock CPR Time

When

PRE-SHOCK CPR time is set to 15 seconds or more, you are prompted to start CPR immediately

after a shockable rhythm is detected, before the shock is delivered.

After analysis is complete, you will see and hear START CPR. A countdown timer (min:sec format) continues for the duration specified in

PRE-SHOCK CPR time setup option (for

the example, 15 seconds). When CPR time ends you will then see and

SHOCK ADVISED. Proceed according to

hear your training with the AED for delivering a shock.

SHOCK button is disabled during the pre-shock CPR interval to avoid accidental shock delivery

The while the defibrillator is charged and a responder is performing CPR.

Troubleshooting Tips for AED Mode

Table 4-1 Troubleshooting Tips for AED Mode

Observation Possible Cause Corrective Action

1 CONNECT ELECTRODES

message appears.

REMOVE TEST PLUG message

appears.

Inadequate connection to defibrillator.

Electrodes do not adhere properly to the patient.

Electrodes are dry, damaged, or out of date.

Test plug connected to therapy cable.

• Check for electrode connection.

• Press electrodes firmly on patient’s skin.

• Clean, shave, and dry the patient’s skin as recommended.

• Replace the electrodes.

• Disconnect test plug from therapy cable.

• Connect electrodes to therapy cable.

4-12 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Therapy

Table 4-1 Troubleshooting Tips for AED Mode (Continued)

Observation Possible Cause Corrective Action

3 MOTION DETECTED and STOP

MOTION

messages appear

during analysis.

Patient movement. • Stop CPR during analysis.

• When patient is being manually ventilated, press complete exhalation.

• Move patient to stable location when possible.

Patient movement because of agonal respirations.

• Press

ANALYZE immediately after

exhalation or wait until agonal respirations are slower or absent.

Electrical/radio frequency interference.

• Move hand-held communication devices or other suspected devices away from the defibrillator when possible.

DISARMING message appears. Electrode disconnected from

patient or AED.

Shock button not pressed within 60 seconds or door is open.

• Replace electrode and press

ANALYZE.

• Press

ANALYZE again.

• Press SHOCK immediately when directed.

5 Voice prompts sound faint or

Low battery power. • Connect to AC power.

distorted.

LOW IMPEDANCE–

RECHARGING

message

Patient impedance <15 ohms detected.

• No action required.

appears.

ANALYZE after

4Therapy

Switching from AED to Manual Mode

If the front console door is closed, you can enter manual mode by pressing the Manual button located in the lower left corner of the door. This opens the door and automatically takes the defibrillator out of AED mode, allowing you to access manual mode defibrillation and pacing.

Note: Closing the door again will not place the defibrillator in AED mode. Pressing Analyze while the defibrillator is in manual mode will place the defibrillator in AED mode.

If the door is not installed, or to manually switch to manual mode, press one of the following keys:

ENERGY SELECT, CHARGE, PACER, LEAD.

Depending on the defibrillator’s configuration, continue to manual mode as follows:

• Direct. No restrictions to manual mode - access is immediate.

• Confirm. A confirmation overlay appears:

Select YES to change to manual mode.

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 4-13

Therapy

• Passcode. A passcode overlay appears:

Enter the passcode to change to manual mode.

Refer to Section 8 for information about changing the defibrillation mode.

MANUAL DEFIBRILLATION

The following paragraphs describe:

• Manual Defibrillation Warnings

• Impedance

• Defibrillation Procedure

• Synchronized Cardioversion Procedure

• Remote Synchronization Procedure

Manual Defibrillation Warnings

WARNINGS!

Possible fire, burns, and ineffective energy delivery.

Precordial lead electrodes and lead wires may interfere with the placement of standard paddles or therapy electrodes. Before defibrillation, remove any interfering precordial lead electrodes and lead wires.

Shock hazard.

Conductive gel (wet or dry) on the paddle handles can allow the electrical energy to discharge through the operator during defibrillation. Completely clean the paddle electrode surfaces, handles, and storage area after defibrillation.

Possible patient skin burns.

During defibrillation, air pockets between the skin and standard paddles can cause patient skin burns. Completely cover paddle electrode surfaces with fresh conductive gel and apply 11.3 kg (25lbs.) of pressure per paddle during discharge.

Possible paddle damage and patient skin burns.

Discharging the defibrillator with the standard paddle surfaces shorted together can pit or damage the paddle electrode surface. Pitted or damaged paddle surfaces may cause patient skin burns during defibrillation. Discharge the defibrillator only as described in these Operating Instructions.

Possible burns and ineffective energy delivery.

A gel pathway on the skin between the standard paddles will cause defibrillating energy to arc between paddles and divert energy away from the heart muscle. Do not allow conductive gel (wet or dry) to become continuous between paddle sites.

Possible damage to defibrillator and defibrillator shutdown.

4-14 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Therapy

WARNINGS!

When used in conjunction with another defibrillator to deliver more than 360J, one or both defibrillators may be damaged and shutdown may occur due to excessive currents. Avoid simultaneous discharge from both defibrillators and maintain a backup device in case one or both defibrillators shut down. If the defibrillator shuts down, take the device out of service and contact a qualified service technician.

To use the LIFEPAK 20 defibrillator/monitor primarily as a manual defibrillator, configure the defibrillator before placing the device in use. To configure the defibrillator, refer to Section 8.

Impedance

LIFEPAK biphasic defibrillators measure the patient's transthoracic impedance and automatically adjust the defibrillation waveform voltage and current duration to meet the needs of the individual patient.

Impedance is measured whenever the defibrillator is charged. To ensure correct patient impedance readings, you should always charge the defibrillator when the standard paddles (hard paddles) or QUIK-COMBO electrodes are in contact with the patient's chest.

If the standard paddles are in the paddle wells or touching face to face (shorted paddles) when the defibrillator is charged, the defibrillator limits the available energy to 79 joules. This prevents damage to the internal circuits, in the event the energy is discharged while the hard paddles are still in the paddle wells or shorted together. If the defibrillator is charged to 80 joules or more and energy is discharged when the hard paddles are seated in the paddle wells, the display indicates the selected energy available and the automatic printout annotates time, date and Shock 79 J.

If the defibrillator is charged to 80 joules or more with paddles in the paddle wells, and then the paddles are removed and placed on a patient, the defibrillator continues charging to the selected energy and defibrillation may be completed as usual. When the defibrillator is charged with the paddles on the patient’s chest, the defibrillator automatically adjusts the waveform voltage and current duration based on the patient's impedance. It is important to understand that this automatic adjustment does not occur when the defibrillator is charged with the paddles seated in the paddle wells.

When the paddles or QUIK-COMBO electrodes are on the patient's chest when the defibrillator is charged and the defibrillator measures an impedance of 15 ohms or less, the defibrillator disarms the capacitor and automatically recharges to a lower energy setting. When this condition occurs, the

IMPEDANCE-RECHARGING

message appears on the display. When charging is complete, defibrillation

may be completed as usual.

LOW

4Therapy

Defibrillation Procedure

You can setup the LIFEPAK 20 defibrillator/monitor to automatically sequence energy levels. Refer to

Manual Mode Setup Menu, page 8-4.

1 Press

2 Identify the electrode or paddle sites on the patient. Use either the anterior-lateral or anterior-

3 Prepare the patient’s skin for electrode application:

4 Connect the therapy electrodes to the therapy cable, and confirm cable connection to the device.

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 4-15

ON.

posterior position as described on page 4-3.

• If possible, place the patient on a firm surface away from standing water or conductive material.

• Remove clothing from the patient’s upper torso.

• Remove excessive hair from the electrode sites; if shaving is necessary, avoid cutting the skin.

• Clean the skin and dry it briskly with a towel or gauze.

• Do not apply alcohol, tincture of benzoin, or antiperspirant to the skin.

Therapy

Note: When in paddles lead, if the REMOVE TEST PLUG message appears, disconnect test plug

and connect therapy electrodes to QUIK-COMBO therapy cable.

5 Apply therapy electrodes to the patient in anterior-lateral or anterior-posterior position. If using

standard paddles, apply conductive gel to the paddles and place paddles on the patient’s chest.

6 Press

7 Press

ENERGY SELECT.

CHARGE. While the defibrillator is charging, a charging bar appears and a ramping tone

sounds, indicating the charging energy level. When the defibrillator is fully charged, an overlay appears (refer to Defibrillation Procedure, page 4-15).

8 Make certain all personnel, including the operator, stand clear of the patient, bed, and any

equipment connected to the patient.

9 Confirm ECG rhythms and available energy.

10 Press the

the charge. If the

SHOCK button(s) to discharge energy to the patient or press the Speed Dial to remove

SHOCK button(s) are not pressed within 60 seconds, stored energy is internally

removed.

Note: If you change the energy selection after charging has started, the energy is removed. Press

CHARGE to restart charging.

11 Observe the patient and the ECG rhythm. If an additional shock is necessary, repeat the procedure

beginning at Step 6.

Note: If the

ABNORMAL ENERGY DELIVERY message appears and the shock is not effective,

increase energy, if necessary, and repeat shock. (Also refer to page 4-20.)

For more information about defibrillation, refer to the booklet, Defibrillation: What You Should Know.

Synchronized Cardioversion Procedure

Note: The LIFEPAK 20 defibrillator/monitor can be configured to remain in synchronous mode or to return to asynchronous mode after discharge. It is important that you know how your defibrillator is configured. Refer to Manual Mode Setup Menu, page 8-4.

1 Press

2 Attach patient ECG cable and ECG electrodes as described previously on page 3-5.

3 Select lead II or the lead with greatest QRS complex amplitude (positive or negative).

4 Press

5 Observe the ECG rhythm. Confirm that a triangle sense marker appears near the middle of each

ON.

Note: To monitor the ECG through therapy electrodes, place the electrodes in the anteriorlateral position and select paddles lead.

WARNING!

Possible lethal arrhythmia.

Ventricular fibrillation may be induced with improper synchronization. DO NOT use the ECG from another monitor (slaving) to synchronize the LIFEPAK 20 defibrillator/monitor discharge. Always monitor the patient’s ECG directly through the ECG cable, therapy cable or use the remote synchronization procedure. Confirm proper placement of the sense markers on the ECG.

SYNC. Confirm the sync LED blinks with each detected QRS complex.

Note: Press

SYNC again to deactivate synchronous mode.

QRS complex. If the sense markers do not appear or are displayed in the wrong locations (for example, on the T-wave), select another lead. (It is normal for the sense marker location to vary slightly on each QRS complex.)

4-16 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Therapy

6 Prepare the patient’s skin for therapy electrode application as described in Step 3 of Defibrillation

Procedure, page 4-15.

7 Connect the therapy electrodes to the therapy cable, and confirm cable connection to the device.

8 Apply therapy electrodes to the patient in the anterior-lateral or anterior-posterior position. If using

standard paddles, apply conductive gel to the paddles and place paddles on the patient’s chest.

9 Press

10 Press

ENERGY SELECT.

CHARGE.

Note: If the

REMOVE TEST PLUG message appears, disconnect test plug and connect therapy

electrodes to QUIK-COMBO therapy cable and press

CHARGE.

11 Make certain all personnel, including operator, stand clear of the patient, bed, and any equipment

connected to the patient.

12 Confirm ECG rhythm. Confirm available energy.

13 Press and hold

release

SHOCK button(s). If SHOCK buttons are not pressed within 60 seconds, stored energy is

SHOCK button(s) until discharge occurs with next detected QRS complex and then

internally removed.

Note: If you change the energy selection after charging has started, the energy is removed internally. Press

CHARGE to restart charging.

14 Observe patient and ECG rhythm. Repeat procedure from Step 4, if necessary.

4Therapy

Remote Synchronization Procedure

WARNINGS!

Possible lethal arrhythmia.

Ventricular fibrillation may be induced with improper synchronization. The hospital’s biomedical engineering staff should perform synchronization delay measurements on the system, as a whole, to ensure that the 60 ms limit for synchronization delay is not exceeded, per requirements as specified in AAMI DF2 (1996). Always confirm proper placement of the sense markers on the ECG.

Possible monitor incompatibility

If the R-wave synchronization markers do not appear to be nearly simultaneous with the R-waves on the remote monitor display or are not present, do not proceed with synchronized cardioversion.

The LIFEPAK 20 defibrillator/monitor can be configured to receive an ECG source from a remote monitor (such as a bedside ECG monitoring system) by means of the ECG/SYNC connector on the back of the defibrillator/monitor. Refer to Manual Mode Setup Menu, page 8-4. The remote monitor must have a sync out connector and a cable must be provided to make this connection. Refer to the LIFEPAK 20 Defibrillator/Monitor Service Manual for more details.

To perform the synchronized cardioversion using a remote monitoring ECG source:

1 Ensure defibrillator/monitor is connected to AC power.

2 Connect the sync cable to the defibrillator/monitor system connector and the remote monitor.

3 Press

4 Attach the ECG cable from the remote monitor to the patient.

5 Press

6 Select

ON.

SYNC on the defibrillator/monitor.

REMOTE SYNC from the menu.

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 4-17

Therapy

Sternum

Apex

Note: The screen on the defibrillator/monitor will display the message REMOTE SYNC in place of any waveforms.

7 Observe the ECG rhythm on the remote monitor. Confirm that a sense marker appears above each

QRS complex.

8 Confirm that the sync LED on the defibrillator/monitor blinks with each detected QRS on the

remote monitor.

9 Follow steps 6 through 14 from Synchronized Cardioversion Procedure provided previously.

PEDIATRIC DEFIBRILLATION

Pediatric paddles are part of the standard paddle set (refer to page 5-6).

Pediatric Paddle Placement

Pediatric paddles should be used for patients weighing less than 10 kg (22 lb) or for patients whose chest size cannot accommodate the adult therapy electrodes.

Adult paddles are recommended if the paddles will fit completely on the patient’s chest. Allow at least

2.5 cm (1 in.) of space between the paddles.

For neonates with very small chests, pediatric paddles may be too large to place in the anterior-lateral position. In this situation, place paddles in the anterior-posterior position. Holding the paddles against the chest and back will support the patient on his/her side.

Do not use the pediatric paddles on adults or older children. Delivery of recommended adult energies through this relatively small electrode surface increases the possibility of skin burns.

Anterior-Lateral

The following is the standard pediatric paddle placement (refer to Figure 4-3):

• Sternum paddle to the patient’s right upper torso, lateral to the sternum and below the clavicle.

• Apex paddle lateral to the patient’s left nipple in the midaxillary line, with the center of the paddle in the midaxillary line if possible.

Figure 4-3 Anterior-lateral Paddle Position

4-18 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Therapy

Sternum

Apex

Anterior-Posterior

Place the sternum paddle anteriorly over the left precordium and the apex paddle posteriorly behind the heart in the infrascapular area (refer to Figure 4-4).

Figure 4-4 Anterior-posterior Paddle Position

Defibrillation Procedure

To defibrillate the patient:

1 Press

2 To access the pediatric paddles, slide the adult paddle forward until it releases.

3 Apply defibrillation gel to the pediatric paddle electrode surfaces.

4 Select the appropriate energy for the weight of the child according to American Heart Association

5 Place the paddles firmly on the patient's chest.

6 Press

7 Make certain all personnel, including the operator, are clear of the patient, the bed, and any

8 Confirm ECG rhythm and available energy.

9 Press the

Note: If the increase energy, if necessary, and repeat shock. (Also refer to page 4-20.)

ON to turn on the defibrillator.

recommendations (or equivalent guidelines).

CHARGE.

equipment connected to the patient.

SHOCK button(s) to discharge energy to the patient or press the Speed Dial to remove

the charge. If

SHOCK buttons are not pressed within 60 seconds, stored energy is internally

removed.

Note: If you change the energy selection after charging has started, the energy is removed.

CHARGE to restart charging.

Press

ABNORMAL ENERGY DELIVERY message appears and the shock is not effective,

4Therapy

Troubleshooting Tips for Defibrillation and Synchronized Cardioversion

Tab l e 4 - 2 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion

Observation Possible Cause Corrective Action

1 Charge time to 360J exceeds

10 seconds.

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 4-19

Battery low. • Connect to AC power.

• Device operating in low temperature environment (<25°C or 77°F).

Therapy

Tab l e 4 - 2 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion (Continued)

Observation Possible Cause Corrective Action

2 Energy not delivered to patient

when SHOCK button(s) are pressed.

Device in sync mode and QRS complexes are not detected.

Device in sync mode; shock button(s) not pressed and held until next detected QRS.

Shock button(s) pressed before full charge reached.

Sixty seconds elapsed before

button(s) pressed after full

shock

• Change ECG lead for optimum sensing QRS or deactivate SYNC.

shock buttons until

•Hold discharge occurs or next detected QRS.

• Wait for tone and message indicating full charge.

• Press Shock button(s) within 60 seconds of full charge.

charge. Energy internally removed.

ENERGY selection changed. • Press CHARGE again.

Test plug connected to QUIKCOMBO therapy cable.

• Disconnect test plug and connect electrodes to QUIKCOMBO therapy cable.

REMOVE TEST PLUG message

appears.

Test plug connected to QUIKCOMBO therapy cable.

• Disconnect test plug and connect electrodes to QUIKCOMBO therapy cable.

CONNECT CABLE or ENERGY

NOT DELIVERED

message

appears.

ENERGY FAULT message

appears (selected and available energy).

DISARMING message appears. Discharge button not pressed

Therapy cable became disconnected and energy was

• Reconnect cable and press charge again.

removed internally.

Defibrillator is out of calibration. • May still transfer energy.

• Contact qualified service personnel.

• Recharge the defibrillator if

within 60 seconds after charge

desired.

complete.

Energy selected after charge

• Recharge the defibrillator.

complete.

Therapy cable disconnects. • Reconnect electrode/cable.

7 Patient didn’t jump (no muscle

response) during defibrillator discharge.

Patient muscle response is variable and depends on patient condition. Lack of visible

• No action needed.

response to defibrillation does not necessarily mean the discharge did not occur.

ABNORMAL ENERGY DELIVERY

message appears and Shock XJ Abnormal annotated on printout.

Therapy cable not connected to therapy electrodes.

Open air discharge with standard paddles.

Discharge occurs with standard

• Connect electrodes to therapy cable.

• Press paddles firmly on patient’s chest when discharging.

• Perform test discharges with defibrillation checker.

• Refer to warning, page 4-14.

paddles shorted together.

Patient impedance out of range. • Increase energy and/or repeat

discharges as needed.

• Consider replacing disposable therapy electrodes with new.

4-20 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Therapy

Tab l e 4 - 2 Troubleshooting Tips for Defibrillation and Synchronized Cardioversion (Continued)

Observation Possible Cause Corrective Action

9 CONNECT ELECTRODES

message appears.

Inadequate connection to defibrillator.

Electrodes do not adhere properly to the patient.

• Check for electrode connection.

• Press electrodes firmly on patient’s skin.

• Clean, shave, and dry the patient’s skin as recommended.

Electrodes are dry, damaged, or

• Replace the electrodes.

out of date.

CONNECT TO AC POWER

message appears.

CONNECT SYNC CABLE TO

REMOTE MONITOR

message

appears.

LOW IMPEDANCE–RECHARGING

message appears.

SEARCHING FOR SIGNAL

message appears.

Remote sync is selected and the device is not connected to AC power.

Remote sync is selected and the device is not connected to the remote monitor.

Patient impedance of <15 ohms detected.

Remote sync is selected and the device is qualifying the input

• Connect to AC power.

• Press SYNC to turn off remote sync.

• Connect to remote monitor.

• Press SYNC to turn off remote synchronization.

• No action required.

signal.

4Therapy

NONINVASIVE PACING

The LIFEPAK 20 defibrillator/monitor provides noninvasive pacing using QUIK-COMBO electrodes.

The following paragraphs include:

• Noninvasive Pacing Warnings

• Demand and Nondemand Pacing

• Noninvasive Pacing Procedure

• Troubleshooting Tips for Noninvasive Pacing

For information about noninvasive pediatric pacing, refer to the Physio-Control Therapy Electrodes Operating Instructions MIN 3200346.

Noninvasive Pacing Warnings

WARNINGS!

Possible inducement of ventricular fibrillation.

Sinus bradycardia may be physiologic in severe hypothermia (i.e., appropriate to maintain sufficient oxygen delivery when hypothermia is present), and cardiac pacing is usually not indicated.

Possible interruption of therapy.

Observe the patient continuously while the pacemaker is in use. Patient response to pacing therapy, e.g., capture threshold, may change over time.

Possible inability to pace.

Using other manufacturers’ combination therapy electrodes with this device could cause a decrease in pacing efficacy or the inability to pace because of unacceptably high impedance levels.

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 4-21

Therapy

WARNINGS!

Possible patient skin burns.

Prolonged noninvasive pacing may cause patient skin irritation and burns, especially with higher pacing current levels. Discontinue noninvasive pacing if skin becomes burned and another method of pacing is available.

Demand and Nondemand Pacing

The noninvasive pacemaker can be used for either demand (synchronous) or nondemand (asynchronous) pacing modes.

The demand mode is used for most patients. In the demand mode, the LIFEPAK 20 defibrillator/ monitor/pacemaker inhibits pacing when it senses the patient’s own beats (intrinsic QRSs). In demand mode, if the ECG amplitude is too low to detect the patient’s beats, or if an ECG lead becomes detached so that the ECG rhythm is not present, the pacemaker generates pacing pulses asynchronously. This means that the pacemaker generates pacing pulses at the selected rate, regardless of the patient’s ECG rhythm.

Asynchronous or nondemand mode can be selected if noise or artifact interferes with proper sensing of QRS complexes. Press the

The LIFEPAK 20 defibrillator/monitor has an integrated pulse oximeter that can be used in conjunction with a noninvasive pacemaker to help confirm capture. To confirm capture, compare the pulse rate measured by the oximeter to the set pacing rate of the pacemaker.

OPTIONS button to access the nondemand mode. (Refer to page 2-6.)

Noninvasive Pacing Procedure

ECG monitoring during pacing must be performed with the ECG electrodes and patient ECG cable. Pacing therapy electrodes cannot be used to monitor ECG rhythm and deliver pacing current at the same time. Be sure to place the therapy electrodes in the proper locations as described in the pacing procedure. Improper electrode placement may make a difference in the capture threshold.

To pace, perform the following:

1 Press

2 Connect the patient ECG cable, apply ECG electrodes to the ECG cable and patient, and select

3 Identify the QUIK-COMBO electrode sites on the patient. For pacing, use either the anterior-lateral

4 Prepare patient's skin for electrode application as described in Step 3 of the Defibrillation

5 Apply QUIK-COMBO electrodes to the patient.

6 Connect the therapy electrodes to the therapy cable.

7 Press

8 Observe the ECG rhythm. Confirm that a triangle sense marker appears near the middle of each

9 Press

ON.

Lead I, II, or III. To receive the best monitoring signal, ensure there is adequate space between the ECG electrodes and the therapy electrodes.

or anterior-posterior position (refer to page 4-3).

Procedure.

PACER. Confirm the LED illuminates, indicating that the power is on.

Note: If the

REMOVE TEST PLUG message appears, disconnect test plug and connect therapy

electrodes to QUIK-COMBO therapy cable.

QRS complex. If the sense markers do not appear or are displayed in the wrong location (for example, on the T-wave)

, select another lead. (It is normal for the sense marker location to vary

slightly on each QRS complex.)

RATE or rotate the Speed Dial to select the desired pacing rate.

Note: The

RATE button changes the rate in 10 pulse per minute (ppm) increments; the Speed

Dial changes the rate in 5 ppm increments.

4-22 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Therapy

10 Press CURRENT or rotate the Speed Dial to increase current until electrical capture occurs. For

each delivered pacing stimulus, the

PACER indicator flashes off and a positive pace marker displays

on the ECG waveform.

11 Palpate the patient's pulse or check blood pressure and compare the SpO2 pulse rate with the set

pacing rate to assess for mechanical capture. Consider use of sedation or analgesia if patient is uncomfortable.

Note: The

CURRENT button changes the current in 10 mA increments; the Speed Dial changes

the current in 5 mA increments. Note: To change rate or current during pacing, press

RATE or CURRENT, then rotate the Speed

Dial. Note: To interrupt pacing and view the patient's intrinsic rhythm, press and hold the

button. This causes the pacer to pace at 25% of the set rate. Release the

PAUSE button to

PAUSE

resume pacing at the set rate.

12 To stop pacing, reduce current to zero or press

Note: To defibrillate and stop noninvasive pacing, press

PACER.

ENERGY SELECT or charge the

defibrillator. Pacing automatically stops. Proceed with defibrillation.

If the monitor detects ECG leads off during pacing, pacing continues at a fixed rate until the ECG lead is reattached. During fixed-rate pacing, the pacemaker delivers pulses at the set pace rate regardless of any intrinsic beats that the patient may have. The monitor continues to display the pacing rate (ppm) and the current (mA). To reestablish demand pacing, reattach the ECG lead.

While pacing, visually monitor the patient at all times, do not rely on the

ECG LEADS OFF warning to

detect changes in pacing function. Routinely assess the ECG for proper sensing, pace pulse delivery, electrical capture, and mechanical capture.

If pacing electrodes detach during pacing, the

CONNECT ELECTRODES and PACING STOPPED messages

appear and an alarm sounds. The pacing rate is maintained and the current resets to 0 mA. Reattaching the pacing electrodes silences the alarm and removes the

CONNECT ELECTRODES

message. The current remains at 0 mA until you increase the current manually.

4Therapy

Troubleshooting Tips for Noninvasive Pacing

Tab l e 4 - 3 Troubleshooting Tips for Noninvasive Pacing

Observation Possible Cause Corrective Action

1 Device does not function

when

PACER is pressed.

PACER LED on, but

CURRENT (MA) will not

increase.

PACER LED on,

CURRENT (MA) >0, but pace

markers absent (not pacing).

4 Pacing stops spontaneously.

Power off. • Check if power is

Low battery. • Connect to AC power.

Therapy electrodes off. • Check for message displayed.

• Inspect therapy cable and electrode connections.

Pacing rate set below patient's

• Increase

PPM.

intrinsic rate.

Pacer oversensing (ECG artifact, ECG size too high).

• Establish clean ECG; decrease ECG size.

• Select nondemand pacing.

PACER button pressed off. • Press PACER and increase the

current.

Internal error detected. Service message indicates an internal failure.

• Check for service indicator.

• Cycle power and start pacing again.

• Obtain service by qualified service personnel.

ON.

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 4-23

Therapy

Tab l e 4 - 3 Troubleshooting Tips for Noninvasive Pacing (Continued)

Observation Possible Cause Corrective Action

Therapy electrode off. • Check for message. Check

pacing cable and electrode connections.

ENERGY SELECT or CHARGE

pressed.

• Press PAC ER and increase current.

• Check for service message.

• Cycle power and start pacing again.

Radio frequency interference. • Move radio equipment away

from pacemaker.

5 Monitor screen displays

distortion while pacing.

ECG electrodes not optimally placed with respect to pacing

• Reposition electrodes away from pacing electrodes.

electrodes.

Patient response to pacing is highly variable with respect to capture

• Select another lead (I, II, or III).

• Consider changing pacing rate.

threshold and ECG distortion.

6 Capture does not occur with

pacing stimulus.

Current (mA) set too low. • Increase pacing current.

(Administer sedation/analgesia as needed.)

CONNECT ELECTRODES

message appears.

Pacing cable or electrode disconnected.

• Reconnect and set current.

Electrodes not adhering to skin. • Prepare skin.

Electrodes outdated. • Replace electrodes and set

current.

8 REMOVE TEST PLUG message

appears.

Test plug connected to therapy cable.

• Disconnect test plug from therapy cable.

• Connect electrodes to therapy cable.

9 Pacing stops spontaneously

PACER FAULT message

and appears.

Internal error detected. • Cycle power and start pacing

again.

• Obtain service by qualified service personnel.

10 Intrinsic QRS complexes not

sensed when pacing.

ECG amplitude too low to be sensed.

Intrinsic QRS complexes are

• Select another lead.

•Adjust

PPM.

occurring during pacemaker's refractory period.

11 Pacing starts spontaneously. Patient’s heart rate falls below set

pacing rate.

During standby pacing, ECG lead

• Appropriate pacemaker function assess patient.

• Reconnect ECG lead.

disconnects.

12 Set pacing rate (ppm) and

ECG paced rate do not

Internal error detected. • Print ECG and calculate the

pace rate.

appear to match.

13 Improper sensing

(e.g., sensing on T-waves).

QRS complex too small. T-wave too large.

• Select another lead.

4-24 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

PADDLE ACCESSORY OPTIONS

Therapy Electrodes page 5-2 Standard Paddle Set (Optional) 5-6 Internal Handles with Discharge Control (MIN 3010901) 5-9

5 Paddle Accessory Options

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 5-1

Paddle Accessory Options

THERAPY ELECTRODES

The following paragraphs describe:

• About Therapy Electrodes

• Electrode Placement

• Cable Connection

• ECG Monitoring and Therapy Procedures

• Replacing and Removing Electrodes

•Testing

About Therapy Electrodes

There are two pre-gelled, self-adhesive therapy electrodes available: QUIK-COMBO pacing/ defibrillation/ECG electrodes and FAST-PATCH defibrillation/ECG electrodes (Figure 5-1). QUIK-COMBO electrodes are used for defibrillation, synchronized cardioversion, ECG monitoring, and pacing. FAST-PATCH electrodes can be used for defibrillation, synchronized cardioversion, and ECG monitoring, but not for pacing. To use FAST-PATCH electrodes with the LIFEPAK 20 defibrillator/ monitor requires the addition of a FAST-PATCH defibrillation adapter cable (MIN 3011030).

Figure 5-1 QUIK-COMBO and FAST-PATCH Electrodes

A QUIK-COMBO or FAST-PATCH electrode set:

• Is a substitute for standard paddles.

• Provides a Lead II monitoring signal when placed in the anterior-lateral position.

• Quickly restores the ECG trace on the monitor following defibrillation.

To help prevent electrode damage:

• Do not fold the electrodes.

• Do not trim the electrodes.

• Do not crush, fold, or store the electrodes under heavy objects.

• Store electrodes in a cool, dry location (59° to 95°F or 15° to 35°C).

5-2 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Paddle Accessory Options

There are several types of QUIK-COMBO electrodes available as described in Table 5-1.

Table 5-1 QUIK-COMBO Electrodes

Type Description

QUIK-COMBO Electrodes, with .6 m (2 ft) of lead wire, designed for

patients weighing 15 kg (33 lb) or more.

QUIK-COMBO - RTS Electrodes, providing a radio-transparent electrode and

lead wire set, designed for patients weighing 15 kg (33 lb) or more.

QUIK-COMBO with REDI-PAK system

™

preconnect

Electrodes designed for patients weighing 15 kg (33 lb) or more and allow preconnection of the electrode set to the device while maintaining electrode shelf life and integrity.

Pediatric QUIK-COMBO Electrodes designed for patients weighing 15 kg (33 lb) or

less.

FAST-PATCH electrodes can be used on pediatric patients if the placement meets conditions noted in the following paragraphs. Usually, these conditions can be met by patients weighing 15 kg (33 lb) or more.

Electrode Placement

When using QUIK-COMBO or FAST-PATCH electrodes, ensure that the electrodes:

• Fit completely on the chest as described on page 3-4 or page 4-3.

• Have at least 2.5 cm (1 in.) of space between electrodes.

• Do not overlap bony prominences of sternum or spine.

To place the electrodes:

1 Prepare the patient for electrode placement:

• Remove all clothing from the patient’s chest.

• Remove excessive chest hair as much as possible. Avoid nicking or cutting the skin if using a shaver or razor. If possible, avoid placing the electrodes over broken skin.

• Clean and dry the skin. If there is ointment on the patient’s chest, use soap and water to clean the skin. Briskly wipe the skin dry with a towel or gauze. This mildly abrades the skin and removes oils, dirt, and other debris for better electrode adhesion to the skin. Do not use alcohol, tincture of benzoin, or antiperspirant to prepare the skin.

2 Slowly peel back the protective liner on the electrodes, beginning with the cable connection end

(refer to Figure 5-2).

Figure 5-2 Peeling the Liner from the Electrode

3 Place the electrodes in the anterior-lateral or anterior-posterior position, as described on page 3-4

or page 4-3, depending on the therapy to be provided and special placement considerations.

4 Starting from one edge, firmly press the electrode on the patient’s chest to eliminate air pockets

between the gel surface and the skin. Firmly press all adhesive edges to the skin.

Note: Once applied, therapy electrodes should not be repositioned.

5 Paddle Accessory Options

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 5-3

Paddle Accessory Options

Therapy cable connector

QUIK-COMBO

electrode connector

Cable Connection

To connect QUIK-COMBO electrodes to the QUIK-COMBO therapy cable:

1 Open the protective cover on the QUIK-COMBO therapy cable connector (refer to Figure 5-3).

2 Insert the QUIK-COMBO electrode connector into the therapy cable connector by aligning the

arrows and pressing the connectors firmly together for proper attachment.

Figure 5-3 Connecting QUIK-COMBO Electrodes to Therapy Cable

To properly connect FAST-PATCH electrodes to the FAST-PATCH defibrillation adapter cable and ensure energy delivery:

1 Attach the defibrillation cable to the electrode post (before applying electrodes to the patient, when

possible).

2 Support the electrode post when attaching the defibrillation cable (refer to Figure 5-4). Firmly press

the cable onto the electrode until a click is heard or felt.

Figure 5-4 Connecting FAST-PATCH Electrodes to Defibrillation Cable

3 Pull up gently on the connector to confirm that the defibrillation cable is securely connected to the

electrode.

Note: If you are reattaching the defibrillation cable to an electrode that is already on the patient, lift the adhesive edge under the electrode post slightly and place your finger under the post. Connect the cable as described in the preceding steps.

ECG Monitoring and Therapy Procedures

WARNINGS!

Possible patient skin burns.

Do not use Pediatric QUIK-COMBO electrodes on adults or larger children. Delivery of defibrillation energies equal to or greater than 100 J (typically used on adults) through these smaller electrodes increases the possibility of skin burns.

Possible pediatric patient skin burns.

Noninvasive pacing may cause patient skin irritation and burns, especially with higher pacing current levels. Inspect underlying skin of the ♥ electrode frequently after 30 minutes of continuous pacing. Discontinue noninvasive pacing if skin burn develops and another method of pacing is available. On cessation of pacing, immediately remove or replace electrodes with new ones.

5-4 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Paddle Accessory Options

For adult patients, follow the procedures for ECG monitoring, AED defibrillation, manual defibrillation, synchronized cardioversion, and pacing described in Section 3 or Section 4.

For pediatric patients, follow the procedures for ECG monitoring, manual defibrillation, synchronized cardioversion, and pacing except for the following:

• Select the appropriate defibrillation energy for the weight of the pediatric patient according to the American Heart Association (AHA) recommendations or local protocol. Using energy levels of 100 J or greater is likely to cause burns.

• When pacing, frequently inspect the patient’s skin under the heart electrode for signs of burns.

Note: The amount of pacing current needed for capture is similar to the pacing current needed for adults.

Replacing and Removing Electrodes

Replace QUIK-COMBO, QUIK-COMBO RTS, QUIK-COMBO REDI-PAK, or FAST-PATCH Plus electrodes after 50 defibrillation shocks or 24 hours on the patient’s skin, or after 8 hours of continuous pacing. Replace pediatric QUIK-COMBO electrodes after 25 defibrillation shocks or 24 hours on the patient’s skin, or after 8 hours of continuous pacing.

To remove QUIK-COMBO or FAST-PATCH electrodes from the patient:

1 Slowly peel back the electrode from the edge, supporting the skin as shown in Figure 5-5.

Figure 5-5 Removing Therapy Electrodes from Skin

2 Clean and dry the patient’s skin.

3 When replacing electrodes, adjust the electrode positions slightly to help prevent skin burns.

4 Close the protective cover on the QUIK-COMBO therapy cable connector when the cable is not in

use.

To disconnect the defibrillation cable from the FAST-PATCH electrodes:

1 Press down around the electrode post.

2 Pinch the snap connector with the fingers of the other hand and pull straight up (refer to

Figure 5-6).

Figure 5-6 Disconnecting Defibrillation Cable from FAST-PATCH Electrodes

WARNING!

Possible cable damage and ineffective energy delivery or loss of monitoring.

5 Paddle Accessory Options

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 5-5

Paddle Accessory Options

WARNING!

Improper disconnection of the defibrillation cable may damage the cable wires. This can result in failure to deliver energy or loss of ECG signal during patient care. Position the cable so that it will not be pulled, snagged, or tripped over. Do not disconnect the defibrillation cable snap connectors from electrode posts or posts on testing devices by pulling on the cable. Disconnect the cable by pulling each cable connector straight out (refer to Figure 5-7).

Figure 5-7 Disconnecting Defibrillation Cable from Test Post

Testing

As part of your defibrillator test routine, inspect and test the QUIK-COMBO therapy cable or FASTPATCH defibrillation adapter cable. Daily inspection and testing will help ensure that the defibrillator and therapy cables are in good operating condition and are ready for use when needed.

Note: During the daily auto test and the user test, energy is discharged through the therapy cable, testing the defibrillation component of the therapy cable. Performing the therapy cable test on the Operator’s Checklist checks the sensing component of the therapy cable. Complete therapy cable integrity is checked when both tests are performed.

If you detect any discrepancy during inspection and testing, remove the therapy cable from use and immediately notify a qualified service technician.

Cleaning and Sterilizing

QUIK-COMBO and FAST-PATCH electrodes are not sterile or sterilizable. They are disposable and are to be used for a single patient application. Do not autoclave, gas sterilize, immerse in fluids, or clean electrodes with alcohol or solvents.

STANDARD PADDLE SET (OPTIONAL)

The following paragraphs describe:

• About the Standard Paddle Set

• Accessing the Pediatric Paddles

• Replacing the Adult Paddle Attachment

• Cleaning the Standard Paddle Set

5-6 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Paddle Accessory Options

SHOCK button

CHARGE button

Charges the defibrillator.

Apex

Sternum

SHOCK button

Discharges defibrillator

energy. Both SHOCK

buttons must be

pressed simultaneously

to deliver energy.

Pediatric paddle

Adult paddle attachment

Figure 5-8 illustrates the standard paddles’ features.

Figure 5-8 Standard Paddles

About the Standard Paddle Set

The standard paddle set consists of two parts:

• The handle assembly, which includes the pediatric paddle

• The adult paddle attachment

Features of the QUIK-LOOK defibrillation paddles can be used with both the pediatric paddle and adult paddle attachment.

Accessing the Pediatric Paddles

To access the pediatric paddles:

1 Grasp the standard paddle handle with one hand and the bottom of the adult paddle electrode with

the other hand.

2 Slide the paddle handle back until you hear a click (refer to Figure 5-9).

3 Lift the paddle handle away from the adult attachment.

4 The pediatric paddle is now exposed and ready for use (refer to Figure 5-10).

Figure 5-9 Accessing a Pediatric Paddle Figure 5-10 Pediatric Paddle (Bottom)

Replacing the Adult Paddle Attachment

To replace the adult paddle attachment:

1 Hold the adult paddle attachment with one hand and the standard handle with the other hand.

2 Fit the pediatric paddle onto the adult paddle attachment.

5 Paddle Accessory Options

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 5-7

Paddle Accessory Options

Pediatric paddle

Adult paddle attachment

3 Slide the paddle handle forward until you hear a click. (Refer to Figure 5-11.)

Figure 5-11 Replacing a Pediatric Paddle

Each adult paddle attachment has a contact spring plate that transfers energy from the pediatric paddle to the adult paddle. Routinely inspect the spring plates and pediatric paddle surfaces to make sure that they are clean and intact.

Cleaning the Standard Paddle Set

Individually protect paddles before and after cleaning to prevent damage to paddle surfaces. After each use:

1 Separate the adult and pediatric paddles.

2 Wipe or rinse paddle electrodes, cable connector, handles, and cables with mild soap and water or

disinfectant using a damp sponge, towel, or brush. Do not immerse or soak.

3 Dry all parts thoroughly.

4 Examine paddles (including electrode surfaces), cables, and connectors for damage or signs of

wear.

Note: Cables showing signs of wear, such as loose cable connections, exposed wires, or cable connector corrosion, should be removed from use immediately.

Note: Paddles with rough or pitted electrodes should be removed from use immediately.

5-8 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Paddle Accessory Options

Electrode

surface

Cam locking

end

INTERNAL HANDLES WITH DISCHARGE CONTROL (MIN 3010901)

The following paragraphs describe:

• About Internal Handles with Discharge Control

• Inserting the Paddles

• Removing the Paddles

• Internal Defibrillation Procedure

• Internal Paddles Synchronized Cardioversion Procedure

• Handling Internal Paddles

• Cleaning and Sterilizing

• Testing

About Internal Handles with Discharge Control

Internal handles with discharge control (Figure 5-12) are specifically designed for open chest cardiac defibrillation and connect directly to the LIFEPAK 20 defibrillator/monitor.

Figure 5-12 Internal Handles with Discharge Control

Internal handles with discharge control are designed to be used only with internal paddles that have the cam locking end as shown in Figure 5-13. No other paddles are compatible with these handles.

Figure 5-13 Internal Paddle

The internal paddles are available in the sizes listed in Ta bl e 5 - 2 :

Tab l e 5 - 2 Paddle Part Numbers

Size in Centimeters Size in Inches MIN Number

2.5 cm 1.0 in. 805355-10

3.8 cm 1.5 in. 805355-11

5.1 cm 2.0 in. 805355-12

6.4 cm 2.5 in. 805355-13

8.9 cm 3.5 in. 805355-14

5 Paddle Accessory Options

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 5-9

Paddle Accessory Options

Inserting the Paddles

To insert the paddles:

1 Using a sterile technique, insert paddle fully into handle until a positive stop is reached.

2 Press and rotate the paddle as shown (clockwise) until a second stop is reached.

3 Release the paddle to lock in place. A correctly installed and locked paddle cannot be directly

withdrawn or rotated.

Removing the Paddles

To remove the paddles:

1 Push the paddle into the handle until a positive stop is reached.

2 Rotate the handle counterclockwise until a second stop is reached.

3 Slide the paddle out of the handle.

Internal Defibrillation Procedure

When internal handles are connected, energy selection is automatically limited to 50 J because of possible cardiac damage from higher energies. To initiate internal defibrillation:

1 Press

2 Press

3 Press

ON. The Joules Selected symbol appears on the screen.

ENERGY SELECT if energy other than 10 J is desired.

CHARGE.

4 Place conductive surface of paddles against the right atrium and left ventricle.

5 Make certain that all personnel, including the operator, are clear of the patient, operating table or

bed, or any other equipment connected to the patient.

6 Press the discharge control located on the internal handle when the defibrillator has reached the

selected energy level. The defibrillator will not discharge until it completes charging to the selected energy level. If discharge control is not pressed within 60 seconds, stored energy is removed automatically.

7 Press the Speed Dial to manually remove an unwanted charge.

Internal Paddles Synchronized Cardioversion Procedure

When internal handles are connected, the energy selection is automatically limited to 50 joules. To use internal paddles for synchronized cardioversion:

1 Connect the internal paddles to the defibrillator.

2 Turn on the defibrillator, and then select Paddles lead.

3 Change the ECG size (gain) to the lowest setting, 0.25.

4 Select the desired energy setting.

5 Place the conductible surface of the paddles against the patient’s atrium and ventricle.

5-10 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Paddle Accessory Options

6 Press SYNC.

7 Confirm that a stable ECG signal is present and that triangle sense markers appear near the

middle of each QRS complex.

Note: The patient’s ECG acquired through internal paddles may be unreliable for synchronized cardioversion due to excessive noise or artifact, causing inappropriate R-wave detection. If the sense markers do not appear or are displayed in the wrong location (for example, on the T-wave), acquire the patient’s ECG through standard ECG electrodes and cable.

8 Press

CHARGE.

9 Make certain that all personnel, including the operator, are clear of the patient, operating table or

bed, or any other equipment that is connected to the patient.

10 When the defibrillator reaches the selected energy level, press and hold the discharge control

located on the internal handle. Discharge will occur with the next detected QRS complex.

11 Observe the patient’s ECG rhythm.

12 If necessary, repeat steps 4 through 11.

Handling Internal Paddles

Observe the following precautionary measures to avoid damage to the coating on internal paddles.

• Immediately following surgery and after removing the handle(s), cover each paddle to help protect the paddles from impact to each other, other instruments, or hard surfaces.

• Use caution while handling the paddles during and after cleaning and before the sterilization wrapping process.

• Inspect the paddles for chips and scratches after each use. If any damage is found, remove the paddle(s) from use immediately.

• Ensure each paddle surface is protected from direct contact with the other while inside the sterilization wrapping.

Cleaning and Sterilizing

Clean and sterilize this accessory according to the sterilization instructions provided with the accessory.

Testing

Perform comprehensive electrical testing using a defibrillator analyzer no less than quarterly or after ten sterilization cycles, whichever comes first.

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 5-11

5 Paddle Accessory Options

DATA MANAGEMENT

6 Data Management

This section describes data management functions.

Overview of Data Storage and Retrieval page 6-2 CODE SUMMARY Report 6-2 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

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 6-1

Data Management

OVERVIEW OF DATA STORAGE AND RETRIEVAL

The following paragraphs describe patient data storage and retrieval using the LIFEPAK 20 defibrillator/monitor.

Data Storage

When you turn on the LIFEPAK 20 defibrillator/monitor, you create a new Patient Record stamped with the current date and time. All events and associated waveforms are digitally stored in the Patient Record as patient reports, which you can print. When you turn off the device, the current Patient Record data is saved in the patient archives.

To access the patient archives, press records stored in the archived Patient Record. When you enter the archives mode, patient monitoring ends and the current Patient Record is saved and closed. Turn off the device to exit the archives mode.

OPTIONS and select ARCHIVES. You can print or delete patient

Report Types

Patient reports within a Patient Record are stored as a CODE SUMMARY Critical Event Record, which includes patient information, event and vital signs logs, and waveforms associated with events (for example, defibrillation) as described on page 6-4.

Memory Capacity

The LIFEPAK 20 defibrillator/monitor retains data for two or more patients when you switch power off or remove the batteries. The number of patient reports that the defibrillator can store depends on various factors, including the number of displayed waveforms, the duration of each use, and the type of therapy. Typically, memory capacity includes up to 100 single waveform reports. When the defibrillator reaches the limits of its memory capacity, the defibrillator deletes an entire Patient Record using a “first in, first out” priority to accommodate a new Patient Record. Deleted Patient Records cannot be retrieved.

CODE SUMMARY REPORT

The LIFEPAK 20 defibrillator/monitor automatically stores a CODE SUMMARY report as part of the Patient Record for each patient. The report consists of the following:

• Preamble

• Event/vital signs log

• Waveforms associated with certain events

6-2 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Data Management

Preamble

Name: DAVIDO, GUIDO CODE SUMMARY™

ID 041495094322

critical event record

Patient ID: 52876004 Power On: 24 April 00 06:03:12 Location: L483 Device: 100 Age: 45 Sex: M Site: ABCD

Total Shocks: 3 Total time paced 00:15:00 Elapsed Time: 00:52:43

35.1 3434 LP20PRB005

Event/Vital Signs Log

Time Event HR SpO2•PR COMMENTS:

07:15:34 Power On 07:16:34 Initial Rhythm 95 99•95 07:20:34 Vital Signs 92 98•94 07:22:14 Pacing 1 Started 95 98•95 07:24:34 Pacing 2 Set 99 98•99 07:25:34 Vital Signs 92 98•93 07:26:36 Alarm HR 152 99

Figure 6-1 is an example of a CODE SUMMARY report. Press CODE SUMMARY to print the report.

6 Data Management

Figure 6-1 CODE SUMMARY Report

Preamble

The preamble contains patient information (name, event identification, patient identification, location, age, and sex) and device information (date, time, and therapy information) as shown in Figure 6-1. The event identification is a unique identifier that the defibrillator automatically enters in the ID field for each Patient Report. This identifier is composed of the date and time that the defibrillator is turned on. The location field allows you to enter up to 25 alpha-numeric characters to identify where the device was used. You can link the data you enter to other patient information.

Event/Vital Signs Log

The LIFEPAK 20 defibrillator/monitor documents events and vital signs in chronological order. Events are operator or device actions that are related to monitoring, pacing, AED therapy, data transmission, and more. Table 6-1 shows a complete listing of events that can be found in the event log.

Vital signs (or active parameters) are entered into the log automatically every 5 minutes (or for each event; refer to

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 6-3

AUTO LOG in Table 8-1) and when alarm limits are exceeded.

Data Management

Table 6-1 Event Types

Event Types Events

Monitoring • Initial rhythm • Alarm events • Vital signs

Operator initiated

• Event • Print • Sync On/Off • Internal Pacer Detection On/Off

• Alarms On • VF/VT Alarm On/Off

Therapy

• AED mode • Connect electrodes • Analysis • Shock advised

AED

• Check patient • Motion • Analysis stopped • No shock advised

Defibrillation • Manual mode • Charge removed • Shock X Delivered • Shock X Not

Delivered

Pacing • Started • Set • Changed • Stopped

• Paused

Memory Status

• Out of

Wavefor m Memory

• Out of Event Memory [memory full]

[memory low]

Waveform Events

In addition to being documented in the Event Log, therapy and other selected events also capture waveform data as described in Ta bl e 6 - 2.

Tab l e 6 - 2 Waveform Events

Event Name Waveform Data

INITIAL RHYTHM • 8 seconds after leads on.

CHECK PATIENT • 8 seconds prior to alert.

SHOCK or NO SHOCK ADVISED

ANALYSIS X STOPPED • 8 seconds of data prior to cessation of analysis.

SHOCK X • 3 seconds prior to shock and 5 seconds after shock.

PACING X STARTED • 8 seconds prior to increase of current from 0.

PACING X SET • 8 seconds after ppm and mA are stable for 10 seconds.

PACING X CHANGED • 8 seconds after pacing rate, current, or mode is changed.

PACING X STOPPED • 3 seconds prior to pacing current is zero and 5 seconds after.

PACING X PAUSED • Initial 8 seconds while

ALARM* • 3 seconds prior to violated parameter and 5 seconds after.

EVENT* • 3 seconds prior to event selection and 5 seconds after.

PRINT • 3 seconds prior to pressing

*To reduce the length of the CODE SUMMARY report, storing waveform data with these events can be configured OFF

(refer to page 8-9).

Waveform events are preceded by a header that includes the following information:

• Patient data

• Event name

• Therapy data

• Vital signs

• Device configuration information

• Transthoracic impedance measured during the shock

• 2–3 segments of analyzed ECG. Each segment may be 2.7 seconds.

PAUSE is pressed.

PRINT and 5 seconds after.

(defibrillation events only)

6-4 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Data Management

Name: DAVIDO, GUIDO

ID: 041495094322 Patient ID: 52876004 Location: BF382 Age: 45 Sex: M 24 Apr 00

Check Patient 14:49:52 HR --

SpO2 89

x1.0 .05-150Hz 25mm/s

Check Patient

010 123 35.1 3434 LP20PRB005

Name: DAVIDO, GUIDO

ID: 041495094322 Patient ID: 52876004 Location: BF382 Age: 45 Sex: M 24 Apr 00

Shock 1 200J14:49:52 Impedance 55 HR --SpO2 89

x1.0 .05-150Hz 25mm/s

Hard Paddles Sync On

Preshock

Postshock

Shock 1 200J

010 123 35.1 3434 LP20PRB005

Name: DAVIDO, GUIDO

ID: 041495094322 Patient ID: 528 7600 4 Location: BF382 Age: 45 Sex: M 24 Apr 00

Pacing 1 Started14:49:52 Demand Pacing 80PPM 40mA

PR 75 SpO2 89

x1.0 .05-150Hz 25mm/s

Sensing Lead II Pacing 1 Started

010 123 35.1 3434 LP20PRB005

Demand Pacing

CODE SUMMARY Format

You can configure the LIFEPAK 20 defibrillator/monitor to print a CODE SUMMARY report in one of the formats described in Ta bl e 6 -3 . CODE SUMMARY reports are always stored in the medium format.

Tab l e 6 - 3 CODE SUMMARY Formats

Format Attributes

6 Data Management

Medium format • Preamble

• Event waveforms

• Event/vital signs log

Short format • Preamble • Event/vital signs log

The format determines only which reports are printed when the

CODE SUMMARY button is pressed. If

you interrupt printing of a CODE SUMMARY report, the entire CODE SUMMARY report will be reprinted when printing is resumed.

CODE SUMMARY Complete is printed immediately following the last waveform event.

Refer to Figure 6-2 for examples of waveform data event printouts in the CODE SUMMARY report.

Check Patient Event

Defibrillation Event

Pacing Event

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 6-5

Data Management

SAS Event

Name: DAVIDO, GUIDO

ID: 041495094322 Patient ID: 52876004 Location: BF382 Age: 45 Sex: M 24 Apr 00

Alarm SpO2 <9014:49:52 HR 121

SpO2 89

x1.0 .05-150Hz 25mm/s

Alarm SpO2 <90

010 123 35.1 3434 LP20PRB005

Parameter Alarm Event

Figure 6-2 Waveform Event Printout Examples

MANAGING ARCHIVED PATIENT RECORDS

When you turn off the LIFEPAK 20 defibrillator/monitor, the current Patient Record is saved in the archives. There are three options for managing archived Patient Records:

• Print archived patient reports

• Edit archived patient records

• Delete archived patient records

To perform any or all of these options, you must first enter the archives mode and then proceed with the desired option.

ENTERING ARCHIVES MODE

To enter the archives mode:

1 Press OPTIONS. 2 Select ARCHIVES.

3 Select YES to enter the patient archives.

YES closes and saves the current

Patient Record and ends patient monitoring. –or– Select

NO to clear the overlay and

return to the previous screen.

6-6 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Data Management

Note: When you enter the archives mode, patient monitoring ends (for example, no ECG, no

alarms) and the current Patient Record is saved and closed.

PRINTING ARCHIVED PATIENT REPORTS

To print:

1 Be sure that you are in the archives mode

(refer to Entering Archives Mode, page

6-6).

2 Select PRINT.

6 Data Management

3 If the PATIENT and REPORT settings are

correct, select PRINT to print the report. Otherwise, select

PATIENT and proceed to

the next step.

4 Select a patient from the list of Patient

Records or select

ALL PATIENTS to print a

list of all Patient Records in the archives.

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 6-7

Data Management

5 Select REPORT to display the report list:

CODE SUMMARY – Prints the CODE

SUMMARY report (medium format). A check mark indicates that a report was

previously printed.

6 Select PRINT.

To return to the Options/Archives menu,

HOME SCREEN.

press –or– To exit the archives mode, turn off the

device.

EDITING ARCHIVED PATIENT RECORDS

To edit:

1 Be sure that you are in the archives mode

(refer to Entering Archives Mode, page

6-6).

2 Select EDIT.

6-8 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

DELETING ARCHIVED PATIENT RECORDS

5252

To delete:

Data Management

3 Select PATIENT. 4 Add or change the necessary patient

information.

5 Press

HOME SCREEN, then turn off the

device.

6 Data Management

1 Be sure that you are in the archives mode

(refer to Entering Archives Mode, page

6-6).

2 Select

DELETE.

3 Select PATIENT.

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 6-9

Data Management

4 Select a patient from the list.

5 Select DELETE to permanently remove the

selected Patient Record from the archives.

Note: If, after you select DELETE, you decide you do not want to remove the patient record, immediately select

UNDO. If you

continue operations, you cannot reverse the

6 Press HOME SCREEN and then turn off the

device.

DELETE selection.

OVERVIEW OF CONNECTIONS FOR TRANSMITTING REPORTS

Patient reports can be transmitted from the LIFEPAK 20 defibrillator/monitor to a PC-compatible computer equipped with the Physio-Control CODE-STAT Suite, SYSTEM VIEW™, QUIK-VIEW™, or CODE-STAT Data Review Software. Refer to the specific release of software for compatible Microsoft Windows

An IrDA port, located on the front of the LIFEPAK 20 defibrillator/monitor (refer to page 2-7), supports wireless, infrared communications for transmitting reports from the defibrillator to your computer. To receive the transmission, your computer must have an operational IrDA port.

If your computer does not have an IrDA port, you can install an IrDA adapter to provide the needed interface. Physio-Control recommends installing an IrDA adapter on all computers to ensure successful communication connections and data transmissions.

IrDA adapters are available for serial or USB computer ports. Follow the installation and usage instructions provided with the adapter, ensuring that the adapter mount (receiving end) is positioned on a stable surface. Figure 6-3 provides guidelines to follow for positioning the defibrillator and the IrDA adapter before initiating a transmission.

Note: The shaded cone in Figure 6-3 represents the approximate parameters for positioning the defibrillator’s IrDA port opposite the IrDA adapter. As the distance between the two increases, so does the possible range for aligning them.

operating systems.

6-10 LIFEPAK 20 Defibrillator/Monitor Operating Instructions

Data Management

IrDA

Adapter/

Computer

Maximum Distance: 3.048 m (10 feet)

0.884 m (2.9 feet)

Defibrillator

0.884 m (2.9 feet)

Alignment Range: 1.768 m (5.8 feet)

Figure 6-3 IrDA Connections

You initiate and control transmission of device data at your computer using the Physio-Control CODESTAT Suite, SYSTEM VIEW™, QUIK-VIEW™, or CODE-STAT Data Review Software. This includes entering patient information, selecting reports to be transmitted, and monitoring transmission progress. More information about configuring the Data Review Software and instructions for transmitting device data are provided in the User’s Guide and Reference Card that accompany your Data Review Software.

6 Data Management

LIFEPAK 20 Defibrillator/Monitor Operating Instructions 6-11

Physio Control Lifepak 20 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual

TABLE OF CONTENTS

PREFACE

ABOUT AUTOMATED EXTERNAL DEFIBRILLATION

Operator Considerations

Indications

Contraindications

ABOUT DEFIBRILLATION THERAPY

Operator Considerations

Indications

Contraindications

ABOUT NONINVASIVE PACING

Indications

Contraindications

ABOUT SPO2 MONITORING

Indications

Contraindications

ABOUT ECG MONITORING

SAFETY INFORMATION

TERMS

GENERAL WARNINGS AND CAUTIONS

SYMBOLS

BASIC ORIENTATION

INTRODUCTION

UNPACKING AND INSPECTING

CONTROLS, INDICATORS, AND CONNECTORS

Area 3

Area 4

Area 6

Changing Printer Paper

Back View

ENTERING PATIENT DATA

SETTING ALARMS

MANAGING ALARMS

CONNECTING TO POWER

AC Operation

Battery Operation

Battery Performance and Life

MONITORING

MONITORING THE ECG

ECG Monitoring Warning

Selecting ECG Lead and Size

Adjusting the Systole Tone Volume

Monitoring ECG with Paddles Accessories

Monitoring with the Patient ECG Cable

Troubleshooting Tips for ECG Monitoring

MONITORING SpO2

SpO2 Warnings and Cautions

When to Use a Pulse Oximeter

How a Pulse Oximeter Works

SpO2 Monitoring Considerations

SpO2 Monitoring Procedure

SpO2 Waveform

SpO2 Volume

Sensitivity

Averaging Time

Pulse Oximeter Sensors

No Implied License

Cleaning

Troubleshooting Tips for SpO2

THERAPY

GENERAL THERAPY WARNINGS AND CAUTIONS

THERAPY ELECTRODE AND STANDARD PADDLE PLACEMENT

Anterior-lateral Placement

Anterior-posterior Placement

Special Placement Situations

AUTOMATED EXTERNAL DEFIBRILLATION

AED Warnings

AED Setup

AED Procedure

Special AED Setup Options

Troubleshooting Tips for AED Mode

Switching from AED to Manual Mode

MANUAL DEFIBRILLATION

Manual Defibrillation Warnings

Impedance

Defibrillation Procedure