Physio Control Lifepak 15 User manual

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LIFEPAK

OPERATING INSTRUCTIONS

MONITOR/DEFIBRILLATOR

Important Information

!USA

LIFEPAK, LIFENET, QUIK-LOOK, and QUIK-COMBO are registered trademarks of Physio-Control, Inc. CODE SUMMARY, Shock Advisory System, CODE-STAT, DT EXPRESS, LIFEPAK CR, REDI-PAK, LIFEPAK EXPRESS, SunVue, and cprMAX are trademarks of Physio-Control, Inc. Bluetooth is a registered trademark of Bluetooth SIG, Inc. CADEX is a registered trademark of Cadex Electronics Inc. Microstream , CapnoLine, and FilterLine are registered trademarks of Oridion Systems Ltd. The Oridion medical capnography in this product is covered by one or more of the following US patents: 6,428,483; 6,997,880; 5,300,859; 6,437,316 and their foreign equivalents. Additional patent applications pending. PC Card is a trademark of the Personal Computer Memory Card International Association. Masimo, SET, Signal Extraction Software, LNCS, and LNOP are registered trademarks of Masimo Corporation. Rainbow, SpCO, and SpMet are trademarks of Masimo Corporation. EDGE System Technology is a trademark of Ludlow Technical Products. Formula 409 is a registered trademark of The Clorox Company. Specifications are subject to change without notice.

MIN 3207184-002

Rx Only

Device Tracking

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

Text Conventions

Throughout these operating instructions, special text characters (for example, CAPITAL LETTERS such as CHECK

PATIENT and SPEED DIAL) are used to indicate labels, screen messages, and voice prompts.

CONTENTS

1Preface

Introduction ...................................................................................................................1-3

Intended Use..................................................................................................................1-3

Modes of Operation .........................................................................................................1-4

2 Safety Information

Terms ............................................................................................................................2-3

General Dangers and Warnings .........................................................................................2-3

3 Basic Orientation

Front View ......................................................................................................................3-3

Back View ....................................................................................................................3-12

Home Screen................................................................................................................3-16

Alarms .........................................................................................................................3-21

Options ........................................................................................................................3-23

Events..........................................................................................................................3-25

4 Monitoring

Monitoring the ECG .........................................................................................................4-3

Acquiring a 12-Lead ECG ..............................................................................................4-14

Monitoring SpO2, SpCO, and SpMet ...............................................................................4-24

Monitoring Noninvasive Blood Pressure ...........................................................................4-35

Monitoring ETCO2.........................................................................................................4-43

Monitoring Invasive Pressure ..........................................................................................4-51

Vital Sign and ST Segment Trends ..................................................................................4-58

5 Therapy

General Therapy Warnings and Cautions ............................................................................5-3

Therapy Electrode and Standard Paddle Placement ............................................................5-4

Automated External Defibrillation (AED)............................................................................5-7

Manual Defibrillation.....................................................................................................5-21

Synchronized Cardioversion Procedure ............................................................................5-26

Noninvasive Pacing .......................................................................................................5-31

Pediatric ECG Monitoring and Manual Mode Therapy Procedures.......................................5-38

6 Paddle Accessory Options

QUIK-COMBO Therapy Electrodes ....................................................................................6-3

Standard Paddles............................................................................................................6-5

7 Data Management

Patient Records and Reports ............................................................................................7-3

Memory Capacity ............................................................................................................7-9

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

iii

Managing Current Patient Records ..................................................................................7-10

Managing Archived Patient Records ................................................................................7-11

8 Data Transmission

About Transmitting Patient Records and Reports................................................................8-3

Preparing the Monitor for Transmission .............................................................................8-4

Using Bluetooth Wireless Communication..........................................................................8-5

Using a Direct Connection..............................................................................................8-10

Transmitting Reports .....................................................................................................8-12

Considerations When Transmitting Data ..........................................................................8-14

Troubleshooting Tips ....................................................................................................8-15

9 Maintaining the Equipment

General Maintenance and Testing .....................................................................................9-3

Battery Maintenance .....................................................................................................9-12

Cleaning the Device.......................................................................................................9-15

Storing the Device.........................................................................................................9-16

Loading Paper ..............................................................................................................9-17

General Troubleshooting Tips .........................................................................................9-18

Service and Repair .......................................................................................................9-20

Product Recycling Information .......................................................................................9-21

Warranty ......................................................................................................................9-21

Accessories ..................................................................................................................9-22

Appendix A: Specifications and Performance Characteristics

Appendix B: Screen Messages

Appendix C: Shock Advisory System

Appendix D: Electromagnetic Compatibility Guidance

Appendix E: Symbols

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

PREFACE

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

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 1-3

Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Modes of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

1-1

PREFACE

Introduction

The LIFEPAK 15 monitor/defibrillator is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols.

These operating instructions include information and procedures related to all features of the LIFEPAK 15 monitor/defibrillator. Your LIFEPAK 15 monitor/defibrillator may not have all of these features.

These operating instructions describe the operation of the LIFEPAK 15 monitor/defibrillator when the factory default settings are used. The factory default settings for all setup options are identified in Table A-5 on page A-14. Your device may be set up with different default settings, based on your protocols. For information about changing default settings, see the LIFEPAK 15 Monitor/ Defibrillator Setup Options provided with your device.

IMPORTANT! Some LIFEPAK 15 monitor/defibrillator accessories are not interchangeable with

accessories that are used with other LIFEPAK monitor/defibrillators. Specific accessory incompatibilities are noted in the related sections.

Intended Use

The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in out-ofdoors and indoor emergency care settings within the environmental conditions specified on page A-10. The LIFEPAK 15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise.

Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.

For additional intended use information, and information about the indications and contraindications of the monitoring and therapy functions, see the individual sections identified below.

• ECG Monitoring See page 4-3 Standard feature

• 12-Lead Electrocardiography See page 4-14 Optional

•SpO

• Noninvasive Blood Pressure Monitoring See page 4-35 Optional

• End-Tidal CO

• Invasive Pressure Monitoring See page 4-51 Optional

• Vital Sign and ST Segment Trends See page 4-58 Optional

SpCO, and SpMet Monitoring See page 4-24 Optional

Monitoring See page 4-43 Optional

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

1-3

• Automated External Defibrillation See page 5-7 Standard feature

• Manual Defibrillation See page 5-21 Standard feature

• Noninvasive Pacing See page 5-31 Standard feature

Modes of Operation

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

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

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

• Archive mode—for accessing stored patient information.

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

• Demo mode—for simulated waveforms and trend graphs for demonstration purposes. For more information, see LIFEPAK 15 Monitor/Defibrillator Demo Mode at www.physio-control.com.

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

1-4

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

SAFETY INFORMATION

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

Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 2-3

General Dangers and Warnings . . . . . . . . . . . . . . . . . . . 2-3

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

2-1

SAFETY INFORMATION

Terms

The following terms are used either in these operating instructions or on the LIFEPAK 15 monitor/ defibrillator:

Danger: Immediate hazards that will result in serious personal injury or death.

Warning: Caution: Hazards or unsafe practices that may result in minor personal injury, product damage, or

property damage.

Hazards or unsafe practices that may result in serious personal injury or death.

General Dangers and Warnings

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

DANGER!

EXPLOSION HAZARD

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

WARNINGS

SHOCK OR FIRE HAZARDS

SHOCK HAZARD

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

SHOCK HAZARD

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

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

2-3

WARNINGS (CONTINUED)

SHOCK OR FIRE HAZARD

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

POSSIBLE FIRE

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

ELECTRICAL INTERFERENCE HAZARDS

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 distorted ECG, incorrect ECG lead status, failure to detect a shockable rhythm, cessation of pacing, or incorrect vital sign measurements. Avoid operating the device near cauterizers, diathermy equipment, or other portable and mobile RF communications equipment. Do not rapidly key EMS radios on and off. Refer to Appendix D for recommended distances of equipment. Contact Physio-Control Technical Support if assistance is required.

POSSIBLE ELECTRICAL INTERFERENCE

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

POSSIBLE ELECTRICAL INTERFERENCE

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

IMPROPER DEVICE PERFORMANCE HAZARDS

POSSIBLE IMPROPER DEVICE PERFORMANCE

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

2-4

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

SAFETY INFORMATION

WARNINGS (CONTINUED)

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 DEVICE SHUTDOWN

Always have immediate access to a spare, fully charged, properly maintained battery. Replace the battery when the device displays a low battery warning.

SAFETY RISK AND POSSIBLE EQUIPMENT DAMAGE

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 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.

Note: The LIFEPAK 15 monitor/defibrillator and its accessories that are intended for direct or

casual contact with the patient are latex-free.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

2-5

BASIC ORIENTATION

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

Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 3-3

Back View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12

Home Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16

Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21

Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23

Events. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

3-1

BASIC ORIENTATION

CO2

SpO2

NIBP

ECG

DANGER Explosion hazard. Do not use in the presence of flammable gases. WARNING Hazardous electrical output. For use only by qualified personn el .

Recommended

Adult VF Dose: 200-300-360J

Front View

Figure 3-1 shows the front of the LIFEPAK 15 monitor/defibrillator. The front of the device is described in the following sections.

Figure 3-1 Front View

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

3-3

Area 1

ENERGY

SELECT

CHARGE

CPR

SIZE

ANALYZE

LEAD

SYNC

Recommended

Adult VF Dose: 200-300-360J

Figure 3-2 Area 1 Controls

3-4

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

BASIC ORIENTATION

Table 3-1 Area 1 Controls

CONTROL DESCRIPTION FOR MORE INFORMATION

VF dose label

1ON

ENERGY

SELECT

3 CHARGE Charges the defibrillator in Manual mode See page 5-21

CPR

ANALYZE

LEAD Changes ECG lead See page 4-4

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

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

Increases or decreases energy level in Manual mode See page 5-21

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

Illuminated Service LED indicates a condition exists that prevents or could prevent normal defibrillator operation

Controls CPR metronome. LED illuminated when metronome function is active.

Activates Shock Advisory System™ (AED mode). LED is illuminated when AED is analyzing the ECG, and flashes when user is prompted to push

ANALYZE.

See Biphasic Clinical Summaries at

www.physio-control.com

See page 5-21

See page 9-18

See page 5-24

See page 5-7

SIZE Changes ECG size See page 4-5

Activates Synchronized mode. LED is illuminated

SYNC

when Sync mode is active and flashes with detection of each QRS.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

See page 5-26

3-5

Area 2

PACER

RATE

CURRENT

PAUSE

Figure 3-3 Area 2 Controls

Table 3-2 Area 2 Controls

CONTROL DESCRIPTION FOR MORE INFORMATION

PACER Activates pacer function. LED illuminated when function

is activated and flashes with each current pulse.

RATE Increases or decreases pacing rate See page 5-31

CURRENT Increases or decreases pacing current See page 5-31

PAUSE Temporarily slows pacing rate See page 5-31

See page 5-31

3-6

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

Area 3

NIBP

ALARMS

OPTIONS

EVENT

HOME

SCREEN

Speed dial

BASIC ORIENTATION

Figure 3-4 Area 3 Controls

Table 3-3 Area 3 Controls

CONTROL DESCRIPTION FOR MORE INFORMATION

NIBP Initiates blood pressure measurement. LED

illuminated when BP measurement is being obtained.

ALARMS Activates and silences alarms. LED illuminated

when alarms are enabled and flashes when an alarm condition occurs.

OPTIONS Accesses optional functions See page 3-23

EVENT Accesses user-defined events See page 3-25

HOME SCREEN Returns to Home Screen display See page 3-16

SPEED DIAL Scrolls through and selects screen or menu items See page 3-19

Display mode button switches between color display and high contrast SunVue™ display

See page 4-35

See page 3-21

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

3-7

Area 4

12-LEAD

TRANSMIT

CODE

SUMMARY

Figure 3-5 Area 4 Controls

Table 3-4 Area 4 Controls

CONTROL DESCRIPTION FOR MORE INFORMATION

12-LEAD Initiates acquisition of 12-lead ECG See page 4-14

TRANSMIT Initiates transmission of patient data See page 8-12

CODE SUMMARY Prints CODE SUMMARY™ critical event record See page 7-4

PRINT Starts and stops printer See page 7-10

3-8

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

Area 5

Speaker

Printer

Therapy cable receptacle

SpO2/ SpCO/

SpMet

NIBP

ECG

CO2

SpO2

NIBP

ECG

See warnings page 2-4

BASIC ORIENTATION

Figure 3-6 Area 5 Connectors, Speaker, and Printer

Table 3-5 Area 5 Connectors, Speaker, and Printer

LABEL DESCRIPTION FOR MORE INFORMATION

CO2 FilterLine® set port See page 4-43

SpO2/SpCO/SpMet Sensor cable port See page 4-24

NIBP Pneumatic tubing port See page 4-35

ECG Green electrically isolated ECG cable port See page 4-3

P1 Invasive pressure cable port See page 4-51

P2 Invasive pressure cable port See page 4-51

Speaker Projects device tones and voice prompts

Printer Door for 100 mm printer paper See page 9-17

Therapy cable receptacle

QUIK-COMBO paddles cable receptacle

therapy cable and standard (hard)

See page 3-11

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

3-9

Connectors

CO2

SpO2

NIBP

ECG

CONNECTOR ACTION

CO2

Connect: Open CO

port door, insert FilterLine connector, and turn

clockwise until connector is firmly seated.

Disconnect: Rotate FilterLine connector counterclockwise and pull connector out.

SpO2/ SpCO/ SpMet

Connect: Align cable connector with SpO

port and push in until

connector clicks into place.

Disconnect: Press the gray buttons on each side of the cable connector simultaneously and pull connector out.

NIBP

Connect: Insert NIBP tubing connector into the NIBP port.

Disconnect: Press the latch on the left side of the port and pull

tubing connector out.

ECG

Connect: Align the green ECG connector with the ECG port; position the white line on the cable facing left. Insert the cable connector into the port until the connector is firmly seated.

Disconnect: Pull the ECG connector straight out.

P1/P2

Connect: Align the IP (invasive pressure) cable connector with the P1 or P2 port; position the gap on the connector facing up. Insert the cable connector into the port until the connector is firmly seated.

Disconnect: Grip the connector and pull straight out.

3-10

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

BASIC ORIENTATION

1. Align the therapy cable connector with the receptacle.

2. Slide the therapy cable until you feel the connector lock in place. You will also hear a

“click.”

1. Press the release button on the therapy cable connector.

2. Slide the therapy cable connector out.

Connecting and Disconnecting the Therapy Cable

WARNING

POSSIBLE EQUIPMENT DAMAGE AND INABILITY TO DELIVER THERAPY

To help protect the therapy cable connector from damage or contamination, keep therapy cable connected to the defibrillator at all times. Inspect and test the therapy cable daily according to the Operator’s Checklist in the back of this manual. PhysioControl recommends replacement of therapy cables every three years to reduce the possibility of failure during patient use.

IMPORTANT!

(hard) paddles have the same type of connector and connect to the defibrillator at the same location. These therapy cables are not compatible with other LIFEPAK defibrillator/monitors.

To connect a therapy cable to the defibrillator:

Figure 3-7 Connect Therapy Cable

To disconnect the therapy cable from the defibrillator:

The LIFEPAK 15 monitor/defibrillator QUIK-COMBO therapy cable and standard

Figure 3-8 Disconnect Therapy Cable

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

3-11

Back View

Standard

paddle

wells

USB port

cover

System

connector

Battery

well 2

exhaust

port

See

warnings

page 9-12

and

page 9-13

See

warnings

page 4-43

See

warning

page 3-13

Battery

pins

Battery

well 1

Battery

contacts

Paddle

retainers

Paddle test

contacts

Figure 3-9 Back View

3-12

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

BASIC ORIENTATION

Table 3-6 Back View

LABEL DESCRIPTION FOR MORE INFORMATION

Battery wells, pins, and contacts

exhaust port Connects to a scavenger system when

Standard paddle wells, retainers, and test contacts

USB port cover Protects USB port from the environment. For future use

System connector Connects device to a gateway or external

Each well holds one Lithium-ion battery. Two pins in each well transfer the battery power. Battery contacts transfer battery status information.

monitoring EtCO

Paddle wells stow standard (hard) paddles. Retainers provide secure retention and quick removal of the paddles. Test contacts allow complete paddles defibrillation checks according to the Operator’s Checklist.

computer for transfer of patient reports. Also provides real-time ECG output.

during use of anesthetics.

See page 9-12

See page 4-43

See page 6-5 and Operator’s Checklist

the back of this manual

See page 7-3

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 defibrillator before using the system connector. Only use Physio-Control recommended data transmission cables. For more information, contact Physio-Control Technical Support.

Note: To prevent inadvertent depletion of the defibrillator batteries, disconnect external devices

from the system connector when not in use.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

3-13

Batteries

The LIFEPAK 15 monitor/defibrillator operates only on battery power using two Lithium-ion batteries, which must be removed from the device and charged in the Station or Mobile Li-ion Battery Charger.

IMPORTANT! The LIFEPAK 15 monitor/defibrillator Lithium-ion batteries are not interchangeable

with batteries that are used in other LIFEPAK defibrillators.

Routinely inspect batteries for damage or leakage. Recycle or discard damaged or leaking batteries.

Each battery has a fuel gauge that indicates the approximate charge level in the battery. Press the gray button above the battery symbol to check the battery’s charge level prior to installing it in the defibrillator. The four battery indicators shown here represent approximate charge—greater than 70%, greater than 50%, greater than 25%, and 25% or less, respectively.

Figure 3-10 Battery Charge Indicators

Battery warning indicators are shown below. A single flashing LED indicates that the battery is very low and needs to be charged. Any two or more flashing LEDs indicate that the battery is faulty and should be returned to your authorized service personnel.

Figure 3-11 Battery Warning Indicators

Note: Older or heavily used batteries lose charge capacity. If a battery fuel gauge indicates fewer

than four LEDs immediately after completing a charge cycle, the battery has reduced capacity. If the battery fuel gauge shows two or fewer LEDs after the battery completes a charge cycle, the battery should be replaced.

To install a battery:

1. Confirm that the battery is fully charged.

2. Inspect battery pins in the battery wells for signs of damage.

3. Align battery so battery clip is over the pins in the battery well.

4. Insert the end of the battery that is opposite the battery clip into the battery well.

5. Firmly press the clip end of the battery into the battery well until it clicks into place.

6. Repeat Step 1 through Step 5 to insert second battery.

3-14

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

BASIC ORIENTATION

To remove a battery, press the battery clip in and tilt the battery out of the battery well.

WARNING

POSSIBLE LOSS OF POWER DURING PATIENT CARE

Battery pins in the defibrillator may be damaged if batteries are dropped or forced into battery wells. Inspect pins routinely for signs of damage. Keep batteries installed at all times except when the device is removed from service for storage.

For information about battery maintenance, see "Battery Maintenance" on page 9-12.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

3-15

Home Screen

Heart rate

SpO

/SpCO/

SpMet

EtCO2

IP1

IP2

NIBP

Channel 1

Channel 2

Channel 3

Message area

Heart symbol

Alarm limits

Bluetooth icon

Battery indicator

Selected energy

ECG Lead/Size

SPO2 %

CO2 mmHg

ART mmHg

CVP mmHg

NIBP mmHg

Alarm indicator

Time

150 50

Figure 3-12 Home Screen

The Home Screen is the main screen that displays ECG and other information. When a monitoring cable is attached to the device, the corresponding monitoring area on the screen is activated and the current patient values for that function are displayed. For example, when you connect an SpO cable, the SpO is connected. When the cable is disconnected, the SpO

area is activated on the screen. SpO2 values for the patient appear after the patient

patient values are replaced by dashes (--).

Separate controls do not activate the monitoring functions, except for NIBP.

Each vital sign monitoring area is colored to match its waveform. This color scheme aids in associating the displayed waveform with its vital sign value. When a function does not have a waveform displayed, the vital sign area is gray.

WARNINGS

FAILURE TO ACCURATELY COUNT HEART RATE

Patient heart rates above 300 bpm may not be counted accurately and may be displayed as dashes (---), a value near 300, or a value that is approximately one-half the actual patient heart rate. Increasing the ECG size to 2.0 or greater may improve the accuracy of the displayed heart rate value. Do not rely solely on the displayed heart rate for patient assessment. Use a printout of the ECG to calculate actual patient heart rate.

3-16

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

BASIC ORIENTATION

WARNINGS (CONTINUED)

FAILURE TO DETECT A CHANGE IN ECG RHYTHM

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

IMPORTANT! Set the high heart rate alarm for patients who have heart rates above 300 bpm.

• For patient heart rates of 20 to 317 bpm, the device consistently sounds the alarm when ECG size is set to 1.0 or greater.

• For patient heart rates of 318 to 350 bpm, the device may intermittently silence the alarm for up to five seconds.

Table 3-7 Home Screen

AREA DESCRIPTION FOR MORE INFORMATION

Alarm limits Limits display along the right side of the

parameter.

Heart symbol Flashes with detected QRS signals.

Alarm indicator Indicates whether alarms are on or silenced.

Absence of indicator means alarms are off.

Heart rate Device accurately detects and displays heart rates

between 20 and 300 beats per minute (bpm). If heart rate is below 20 bpm or pacing is active, dashes (– – –) appear. If ECG is not active, the

or NIBP monitor can display pulse rate,

SpO

indicated by patient’s heart rate is above 300 bpm, dashes (--) may appear or the displayed rate may be less than the patient’s heart rate.

SpO2/SpCO/SpMet Oxygen saturation level displays as a percentage

from 50 to 100. Saturation below 50% displays as <50%. A fluctuating bar graph represents the pulse signal strength. When available and selected, the SpCO or SpMet value is displayed as a percent for 10 seconds, and then the SpO area reverts to the SpO

EtCO2 End-tidal CO

kPa. Respiratory rate (RR) displays in breaths per minute.

PR (SPO2) or PR (NIBP). If the

reading.

level displays in mmHg, Vol%, or

See page 3-21

See page 4-24

See page 4-43

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

3-17

Table 3-7 Home Screen (Continued)

AREA DESCRIPTION FOR MORE INFORMATION

IP1/IP2 Displays systolic, diastolic, and mean invasive

pressures in mmHg. Two channels are available; default labels are P1 and P2.

User-selectable labels include the following:

• ART (arterial pressure)

• PA (pulmonary artery pressure)

• CVP (central venous pressure)

• ICP (intracranial pressure)

• LAP (left atrial pressure)

NIBP Displays systolic, diastolic, and mean arterial

pressures (MAP) in mmHg, and time to next BP, when interval is set.

Time Real or elapsed. See LIFEPAK 15

Bluetooth icon Indicates Bluetooth capability. The LED is

illuminated when a Bluetooth connection is established. Select this icon to access the Bluetooth setup menu.

Battery indicator Indicates presence of battery in battery well 1

and 2, relative level of charge, and battery in use.

See page 4-51

See page 4-35

Monitor/Defibrillator Setup Options provided

with your device.

See page 8-3

See page 3-20

Selected energy Selected defibrillation energy.

ECG Lead/Size Lead and size for ECG. See page 4-4

Channel 1 Displays the primary ECG waveform and is always

visible.

Channel 2 Displays an additional waveform, a continuation

of the Channel 1 ECG (cascading ECG), or a trend graph.

Channel 3 Displays an additional waveform or a trend graph. See page 4-62

Message area Displays up to two lines of status messages. See Appendix B

See page 4-4

See page 4-31

3-18

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

BASIC ORIENTATION

Waveform

Channel 3

CO2 SpO2 Trend

None

1. Rotate the SPEED DIAL to the desired setting.

2. Press the

SPEED DIAL to select the setting.

Navigating the Home Screen

Use the SPEED DIAL to navigate around the Home Screen. As you rotate the SPEED DIAL, the individual vital sign areas and waveform channels on the Home Screen are outlined. If you outline a vital sign area or channel and then press the

SPEED DIAL, a menu appears.

For example, rotate the following menu appears.

Whenever a menu is displayed, the ECG is always visible in Channel 1. To return to the Home Screen from any menu, press the

Rotate and press the

SPEED DIAL to outline Channel 3, and then press the SPEED DIAL. The

HOME SCREEN button.

SPEED DIAL to select an option in a menu.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

3-19

Battery Status Indicators

The Home Screen displays battery indicators that show the following information about the batteries installed in the defibrillator:

• Presence or absence of battery in battery well

• Battery in use

• Battery charge state

When two batteries are installed, the defibrillator uses the battery with the lowest level of charge first. The battery in use is indicated by a white battery number in a black box. When a battery reaches the replace battery state, the defibrillator automatically switches to the other battery. Table 3-8 provides a description of the various battery status indicators.

Table 3-8 Battery Status Indicators

INDICATOR MEANING DESCRIPTION

The defibrillator is using the battery in well 1 for power. Battery status

Active battery

indicators display up to four green bars. Each green bar represents approximately 25% remaining charge. For example, three green bars indicate about 75% remaining charge.

Low battery

Very low battery

Unrecognized battery

No battery installed or fault detected

Battery in well 1 is in use and is low. One yellow bar indicates 5% to 10% remaining charge.

Battery in well 1 is in use and is very low. One red flashing bar indicates 0 to 5% remaining charge. The defibrillator automatically switches to the other battery only if adequate charge is available. If both batteries show red bars, the occurs.

Battery in well 2 is not in use. Battery communication failed or a nonPhysio-Control battery is installed. The battery may power the defibrillator but the level of charge is unknown and low battery messages and prompts will not occur.

No battery is installed in battery well 1, or a fault was detected in the battery in well 1 and the device will not use the battery.

REPLACE BATTERY voice prompt

Note: Older or heavily used batteries lose charge capacity. If a fully charged battery is installed in

the defibrillator and the battery status indicator shows less than four bars, the battery has reduced capacity. If a battery status indicator shows only one or two bars after a fully charged battery is installed, the battery has less than half the normal use time and should be recycled.

3-20

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

BASIC ORIENTATION

Select QUICK SET to activate the alarms for all active monitoring functions.

The Quick Set

limits automatically set high and

low limits based on the patient’s current vital sign values. For example, if the patient’s HR is 70, selecting

WIDE results in a high limit of

110 and a low limit of 45; selecting NARROW results in a high limit of 100 and a low limit of

50. The default is

WIDE.

Alarms

Quick Set Limits Silence VF/VT Alarm

Wide 2 Min Off

Select LIMITS to change alarm limits to WIDE or

NARROW. See Table A-3 on page A-12.

Select SILENCE to turn off the audible alarm for up to 15 minutes. If an alarm limit is exceeded while the alarm is silenced, the violated vital sign flashes and an alarm message appears, but the alarm tone remains silent.

Alarms

Quick Set Limits Silence VF/VT Alarm

Wide

Narrow

Alarms

LIFEPAK 15 monitor/defibrillator alarms can be set up to be ON or OFF when the defibrillator is turned on. For more information, see the LIFEPAK 15 Monitor/Defibrillator Setup Options provided with your device.

When alarms are set up to be ON, default limits are set. The limits temporarily appear to the right of the active vital signs. For all vital sign default alarm limits, see Table A-3 on page A-12.

If alarms are set up to be OFF, press ON or are enabled by pressing device. If power is lost for less than 30 seconds, for example due to a system reset or changing the only active battery, alarm settings are restored automatically.

IMPORTANT! Set the high heart rate alarm for patients who have heart rates above 300 bpm.

• For patient heart rates of 20 to 317 bpm, the device consistently sounds the alarm when ECG size is set to 1.0 or greater.

• For patient heart rates of 318 to 350 bpm, the device may intermittently silence the alarm for up to five seconds.

ALARMS to enable the alarms. Whether alarms are set up to be

ALARMS, they can only be turned off by pressing ON to turn off the

Setting Alarms

When you press ALARMS, the following menu appears:

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

3-21

Note: For patients with heart rates above 300 bpm, increasing the ECG size to 2.0 or greater may

Alarms

Quick Set Limits Silence VF/VT Alarm

Wide 2 Min Off

Select VF/VT ALARM to turn on continuous monitoring for ventricular fibrillation and ventricular tachycardia in Manual mode.

The VF/VT alarm indicator appears above the primary ECG when the alarm is ON.

When the alarm is silenced or suspended, a red X appears across the indicator .

Reselect

VF/VT to turn off this alarm.

improve the performance of the heart rate alarm.

Note: The heart rate display and corresponding heart rate alarm should not be relied upon to

provide an indication of ventricular fibrillation. Turn on the VF/VT alarm.

Note: When the VF/VT ALARM is ON, you are limited to PADDLES lead or Lead II in Channel 1. See

"Selecting ECG Lead" on page 4-4.

Note: The VF/VT alarm is suspended when the metronome is active, the noninvasive pacemaker is

on, or when standard paddles are attached and suspended when the monitor/defibrillator is charging or is charged.

PADDLES lead is selected. The alarm is also

3-22

Managing Alarms

The alarm bell symbol indicates when alarms are ON or OFF . All alarms that are controlled by tone sounds and the violated vital sign flashes.

To manage an alarm:

1. Press

2. Assess the cause of the alarm.

3. Assess the appropriateness of the limits settings (

If the patient is unstable, consider silencing the alarm for up to 15 minutes while attending to the patient. Do NOT reselect

WARNING

POSSIBLE FAILURE TO DETECT AN OUT OF RANGE CONDITION

4. After the patient is stable, reselect

QUICK SET have equal priority. When alarms are ON and an alarm limit is exceeded, a

ALARMS. This silences the alarm for 2 minutes.

WIDE or NARROW).

QUICK SET.

Reselecting QUICK SET resets the alarm limits around the patient’s current vital sign values, which may be outside the safe range for the patient.

QUICK SET, if necessary.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

BASIC ORIENTATION

Options

Patient... Pacing... Date/Time... Alarm Volume...

Archives... Print... User Test

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

To silence alarms preemptively:

1. Press

2. Select

3. Select

The message

ALARMS.

SILENCE.

SILENCE duration of 2, 5, 10, or 15 minutes.

ALARMS SILENCED appears in the message area at the bottom of the Home Screen.

Note: When you select SILENCE, the VF/VT alarm is not silenced.

Options

Press OPTIONS to display the Options menu. Rotate the SPEED DIAL to scroll through the choices. Press the

SPEED DIAL to make a selection.

Table 3-9 Options Menu Selections

SELECTION DESCRIPTION FOR MORE INFORMATION

Patient

Pacing

Date/Time

Alarm Volume

Archives Access archived patient records. See page 7-11

Enter patient name, patient ID, incident, age, and sex.

Select demand or nondemand pacing. Set internal pacer detection ON or OFF.

Set date and time. Cycle power for change to take effect.

Adjust volume for alarms, tones, voice prompts and CPR metronome.

See "Entering Patient Data" in next section

See page 5-31

See LIFEPAK 15

Monitor/Defibrillator Setup Options for time

display options.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

3-23

Table 3-9 Options Menu Selections (Continued)

Options

Patient... Pacing... Date/Time... Alarm Volume...

Archives... Print... User Test

1. Press OPTIONS.

2. Use the

SPEED DIAL to select PATIENT.

3. Select LAST NAME, FIRST NAME, PATIENT ID,

INCIDENT, AGE, or SEX. (LAST NAME is

selected in the example.)

Options / Patient

Last Name... First Name... Patient ID... Incident... Age Sex

4. Rotate the SPEED DIAL to scroll through the characters and commands. Press the

SPEED

DIAL

to make a selection. The selected

character appears.

5. Repeat Step 4 until the name is complete.

6. Select

END.

Three additional commands are available:

SPACE—inserts blank space. BACKSPACE—deletes last character and

moves selection back one space.

CLEAR—clears all characters.

Options / Patient / Last Name

BCDEFGHIJKLMNOPQRSTUVWXYZ

Last Name: _ _ _ _ _ _ _ _ _ _ _ _ _ _

End Space

Backspace

Space

Clear

End

0 1 2 3 4 5 6 7 8 9 -

SELECTION DESCRIPTION FOR MORE INFORMATION

User Test Initiate device self-test. See page 9-5

Select report, format, mode, and speed for printing a current patient report.

See page 7-10

Entering Patient Data

To enter patient data:

3-24

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

BASIC ORIENTATION

1. Press EVENT to display the Events menu.

2. Rotate the

SPEED DIAL to scroll through the

choices. Press the

SPEED DIAL to make a

selection.

3. Select

MORE to display additional event

selections.

Events

Generic Oxygen IV Access Nitroglycerin Morphine Cancel Last

Intubation CPR Epinephrine Atropine Lidocaine More...

When an event is selected, the event and time stamp appear in the message area on the Home Screen.

Generic 12:20:30

Events

Use the Events menu to annotate patient events. A selected event appears in the Event log of the CODE SUMMARY critical event record. Events can be customized in Setup mode. For more information, see the LIFEPAK 15 Monitor/Defibrillator Setup Options provided with your device.

To select an event:

Notes:

• If you highlight an event but do not select it and the menu times out, a Generic event and time stamp are annotated in the event log.

• If you highlight an event but do not select it and then press time stamp are annotated in the event log.

• Select time stamp print in the event log.

CANCEL LAST to indicate that an incorrect event was selected. A Cancel Last event and

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

HOME SCREEN, a Generic event and

3-25

MONITORING

This chapter describes the monitoring features of the LIFEPAK 15 monitor/defibrillator.

Monitoring the ECG . . . . . . . . . . . . . . . . . . . . . . . page 4-3

Acquiring a 12-Lead ECG . . . . . . . . . . . . . . . . . . . . . . 4-14

Monitoring SpO2, SpCO, and SpMet . . . . . . . . . . . . . . 4-24

Monitoring Noninvasive Blood Pressure . . . . . . . . . . . . 4-35

Monitoring ETCO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-43

Monitoring Invasive Pressure . . . . . . . . . . . . . . . . . . . . 4-51

Vital Sign and ST Segment Trends . . . . . . . . . . . . . . . . 4-58

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-1

MONITORING

Monitoring the ECG

Intended Use

The electrocardiogram (ECG) 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.

ECG monitoring is a tool to be used in addition to patient assessment. Care should be taken to assess the patient at all times; do not rely solely on the ECG monitor.

ECG Monitoring Warning

WARNINGS

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 multi-lead ECG cable. Then print the ECG rhythm in diagnostic frequency response (DIAG) or obtain a 12-lead ECG.

FAILURE TO ACCURATELY COUNT HEART RATE

IMPORTANT! Set the high heart rate alarm for patients who have heart rates above 300 bpm.

• For patient heart rates of 20 to 317 bpm, the device consistently sounds the alarm when ECG size is set to 1.0 or greater.

• For patient heart rates of 318 to 350 bpm, the device may intermittently silence the alarm for up to five seconds.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-3

Selecting ECG Lead

1. Press LEAD. If any ECG lead currently appears on the Home Screen, the lead changes to

PADDLES. If PADDLES lead is currently

displayed, the lead changes to Lead

II.

2. While the

LEAD menu is displayed, press LEAD

again or rotate the

SPEED DIAL to the desired

lead.

Note: If lead sets are predefined for Channels 2 and 3, the lead sets show on the menu. The ECG cable that is connected to the device, such as 3lead or 5-wire, determines the leads you can select. For information about defining lead sets, see the LIFEPAK 15 Monitor/Defibrillator Setup Options provided with your device.

Lead

III

AVR

AVL

AVF II, CO2 I, II, III

AVR, AVL, AVF

Paddles

1. For the primary ECG, outline and select

CHANNEL 1 and then select LEAD.

2. Rotate the

SPEED DIAL to the desired ECG

lead.

3. Press the

SPEED DIAL to select the ECG lead.

4. Repeat this procedure to select or change displayed ECG waveforms for Channels 2 and 3.

Channel 1

Lead Size 1.0

The LIFEPAK 15 monitor/defibrillator includes two methods for selecting or changing the ECG lead.

To select or change the displayed ECG lead using the

LEAD button:

To select or change the displayed ECG lead using the SPEED DIAL:

Note: The ECG shows dashed lines until the electrodes are connected to the patient.

Note: When the VF/VT ALARM is ON, you are limited to PADDLES lead or Lead II in Channel 1. See

"Setting Alarms" on page 3-21.

4-4

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

1. Press SIZE.

2. While the

SIZE menu is displayed, press SIZE

again or rotate the

SPEED DIAL to the desired

size.

Size

1. For the primary ECG, outline and select

CHANNEL 1 and then select SIZE.

2. Rotate the

SPEED DIAL to the desired ECG

size.

3. Press the

SPEED DIAL to select the ECG size.

Channel 1

Lead Size

1.0

Changing ECG Size

The LIFEPAK 15 monitor/defibrillator includes two methods for selecting or changing ECG size.

To select or change the displayed ECG size using the

SIZE button:

SPEED DIAL:

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-5

Adjusting the Systole Volume

1. Press the SPEED DIAL to select QRS VOLUME.

2. Rotate the

SPEED DIAL to the desired volume.

3. Press the

SPEED DIAL to set the volume.

QRS Volume

Lateral

QUIK-COMBO Therapy Electrodes

Standard Paddles

Sternum

Apex

To adjust the systole beep volume, use the SPEED DIAL to outline and select the HR area on the Home Screen.

The following menu appears:

Note: The volume is reset to OFF each time the device is turned off.

Monitoring Using Paddle Accessories

To monitor ECG using paddles, you can use either QUIK-COMBO therapy electrodes or standard (hard) paddles. For more information about paddle accessories, see Chapter 6, "Paddle Accessory Options."

Anterior-Lateral Placement

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

To place the therapy electrodes or paddles:

1. Place either the ♥ therapy electrode or midaxillary line, with the center of the electrode in the midaxillary line, if possible (see Figure 4-1).

Figure 4-1 Anterior-Lateral Placement

APEX paddle lateral to the patient’s left nipple in the

4-6

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

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.

Special Situations for Electrode or Paddle Placement

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 Devices Such as Pacemakers or Defibrillators

If possible, place therapy electrodes or standard paddles away from implanted device.

Paddles ECG Monitoring Procedure

To monitor using standard paddles or therapy electrodes:

1. Press

2. Prepare the patient’s skin:

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

4. Connect the therapy electrodes to the therapy cable.

ON.

• 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 electrodes over broken skin.

• Clean and dry the skin, if necessary. Remove any medication patches and ointment on the patient’s chest.

• 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 prep the skin.

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

5. Select

PADDLES lead.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-7

Monitoring Using ECG Cable Accessories

Limb lead

attachment

12-Lead Cable

3-Lead Cable

5-Wire Cable

Main cable

Precordial lead

attachment

AHA Labels IEC Labels

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

*Note: Not used for 3-lead cable.

LA/LRA/R

LL/FRL/N

The following ECG cables, shown in Figure 4-2, are available for ECG monitoring with the LIFEPAK 15 monitor/defibrillator:

•12-lead

•3-lead

• 5-wire

4-8

Figure 4-2 12-Lead, 3-Lead, and 5-Wire ECG Cables

ECG Monitoring Procedure

To perform ECG monitoring:

1. Press

2. Attach the ECG cable to the green connector on the monitor.

3. Identify the appropriate electrode sites on the patient as shown in Figure 4-3.

ON.

Figure 4-3 Limb Lead Electrode Placement

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

4. Prepare the patient’s skin for electrode application:

• Shave excessive hair at electrode site.

• For oily skin, clean skin with alcohol pad.

• Gently scrape skin to remove surface layer of dead cells and improve conduction of electrical signals.

• Avoid locating electrodes over tendons and major muscle masses.

• Clean and dry the skin.

5. Apply ECG electrodes:

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

• Attach an electrode to each of the lead wires.

• Grasp electrode tab and peel electrode from carrier.

• Inspect electrode gel and make sure 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.

Note: Electrode quality is critical for obtaining an undistorted ECG signal. Always check the

date code on electrode packages for expiration date before using on a patient. Do not use electrodes that have expired. Disposable electrodes are intended for a single use.

6. Select the desired ECG lead on the monitor screen.

7. If necessary, adjust ECG size for accurate heart rate counting.

8. Press

PRINT to obtain an ECG printout.

Precordial Lead ECG Monitoring

The precordial (chest) leads (see ECG Leads Color Codes on page 4-10) can be used for monitoring when using the 12-lead cable or 5-wire cable.

To perform precordial lead ECG monitoring:

1. Insert the precordial lead attachment into the main cable as shown in Figure 4-2 on page 4-8.

2. Place the precordial lead electrodes on the chest as described in the 12-lead ECG procedure and shown in Figure 4-5 on page 4-15.

Note: When using a 5-wire cable, attach the limb leads as described in "ECG Monitoring

Procedure" on page 4-8, and place the C-lead electrode on the chest in the precordial position desired. Note that the LIFEPAK 15 monitor labels the ECG for this lead as V1 on the screen and printout, regardless of the location of the C-lead electrode.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-9

Leads Off

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 American Heart Association (AHA) or International Electrotechnical Commission (IEC) standards as listed in Table 4-1.

Table 4-1 ECG Leads Color Codes

LEADS AHA LABEL AHA COLOR IEC LABEL IEC COLOR

Limb Leads RA

LA RL LL

Precordial Leads V1

V2 V3 V4 V5 V6

White Black Green Red Brown

Red Yellow Green Blue Orange Violet

R L N F C

C1 C2 C3 C4 C5 C6

Red Yellow Black Green Brown

Red Yellow Green Brown Black Violet

Monitoring Patients Who Have Internal Pacemakers

The LIFEPAK 15 monitor/defibrillator internal pacemaker detection feature can be used to help identify internal pacemaker pulses on the printed ECG. When enabled, this feature uses lead V4 to detect internal pacemaker pulses. If V4 is not available because it is not attached or is too noisy, Lead II is used.

When the internal pacemaker detection feature is ON, the LIFEPAK 15 monitor/defibrillator annotates a hollow arrow on the printed ECG if internal pacemaker pulses are detected. Patient history and other ECG waveform data, such as wide QRS complexes, should be used to verify the presence of an internal pacemaker. False annotations of this arrow may occur if ECG artifacts mimic internal pacemaker pulses. If false annotations occur frequently, deactivate the detection feature using the

OPTIONS / PACING / INTERNAL PACER menu (see "Options" on page 3-23).

4-10

The LIFEPAK 15 monitor/defibrillator typically does not use internal pacemaker pulses to calculate the heart rate. However, when using therapy electrodes or standard paddles to monitor in

PADDLES lead, the monitor may detect internal pacemaker pulses as QRS complexes, resulting

in an inaccurate heart rate.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

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, place ECG electrodes so the line between the positive and negative electrodes is perpendicular to the line between the pacemaker generator and the heart.

Smaller amplitude internal pacemaker pulses may not be distinguished clearly in For improved detection and visibility of internal pacemaker pulses, turn on the internal pacemaker detector function using the ECG cable, select an ECG lead, and print the ECG in diagnostic frequency response. For information about configuring internal pacemaker detection, see the Pacing Setup menu in the LIFEPAK 15 Monitor/Defibrillator Setup Options provided with your device.

OPTIONS / PACING / INTERNAL PACER menu or connect the

PADDLES lead.

Troubleshooting Tips

If problems occur while monitoring the ECG, check Table 4-2 for aid in troubleshooting. For basic troubleshooting problems, such as no power, see General Troubleshooting Tips on page 9-18.

Table 4-2 Troubleshooting Tips for ECG Monitoring

OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION

Any of these messages displayed:

CONNECT ELECTRODES CONNECT ECG LEADS ECG LEADS OFF XX LEADS OFF

Therapy electrodes not connected

One or more ECG electrodes disconnected

ECG cable is not connected to monitor

• Connect therapy electrode.

• Connect ECG electrode.

• Connect ECG cable.

Screen blank and illuminated

ON LED

Poor electrode-skin contact • Reposition cable or lead wires to

prevent electrodes from pulling away from patient.

• Secure trunk cable clasp to patient’s clothing.

• Prepare skin and apply new electrodes.

PACER was pressed. The

monitor automatically switched to Lead II, but ECG leads are not connected.

Broken ECG cable lead wire • Select another lead.

Screen not functioning properly

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

• Connect ECG leads and initiate pacing.

• Select

• Check ECG cable continuity.

• Print ECG on recorder as backup.

• Contact service personnel for

PADDLES lead, and use

standard paddles or therapy electrodes for ECG monitoring.

repair.

4-11

Table 4-2 Troubleshooting Tips for ECG Monitoring (Continued)

OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION

Systole beeps not heard or do not occur with each QRS complex

Displayed heart rate (HR) different than pulse rate

Displayed heart rate (HR) different from displayed ECG waveform

Poor ECG signal quality Poor electrode-skin contact • Reposition cable or lead wires to

Volume too low • Adjust volume.

QRS amplitude too small to detect

ECG size set too high or too low

Monitor detecting the patient’s internal pacemaker pulses

Patient’s heart rate greater than 300 bpm

ECG size set too high or too low

Monitor detecting the patient’s internal pacemaker pulses

Patient’s heart rate greater than 300 bpm

• Adjust ECG size.

• Adjust ECG size

• Change monitor lead to reduce internal pacemaker pulse size.

• Adjust ECG size to 2.0 or greater.

• Adjust ECG size

• Change monitor lead to reduce internal pacemaker pulse size.

• Adjust ECG size to 2.0 or greater.

• Use printout of the ECG to calculate actual patient heart rate.

prevent electrodes from pulling away from patient.

• Secure trunk cable clasp to patient’s clothing.

• Prepare skin and apply new electrodes.

up or down.

4-12

Outdated, corroded, or driedout electrodes

Loose connection. Damaged cable or connector/ lead wire

Noise because of radio frequency interference (RFI)

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

• Check Use By date on electrode packages.

• Use only unexpired silver/silver chloride electrodes. Leave electrodes in sealed pouch until time of use.

• Check or reconnect cable connections.

• Inspect ECG and therapy cables. Replace if damaged.

• Check cable with simulator and replace if malfunction observed.

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

MONITORING

Table 4-2 Troubleshooting Tips for ECG Monitoring (Continued)

OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION

Baseline wander (low frequency/high amplitude artifact)

Fine baseline artifact (high frequency/low amplitude)

ECG amplitude too small Poor electrode-skin contact • Prep skin, apply new electrodes.

Monitor displays dashed lines with no ECG

OFF

messages

LEADS

Inadequate skin preparation • Prepare skin and apply new

electrodes.

Poor electrode-skin contact • Check electrodes for proper

adhesion.

Diagnostic frequency response • Print ECG in monitor frequency

response.

Inadequate skin preparation • Prepare skin and apply new

electrodes.

Isometric muscle tension in arms/legs

ECG lead selected • Increase ECG gain or change ECG

Patient condition (for example, significant myocardial muscle loss or tamponade)

PADDLES lead selected but

patient connected to ECG cable

• Confirm that limbs are resting on a supportive surface.

• Check electrodes for proper adhesion.

lead.

• Increase ECG gain or change ECG lead.

• Select one of the limb or precordial leads.

Monitor shows isoelectric (flat) line and selected

Internal pacemaker pulses difficult to see

For general troubleshooting tips, see Table 9-2 on page 9-18.

PADDLES lead

The Test Load is connected to therapy cable

Pacemaker pulses are very small

Monitor frequency response limits visibility

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

• Remove the Test Load and connect therapy electrodes to cable.

• Connect ECG cable and select another lead.

• Turn on internal pacemaker detector (see "Monitoring Patients Who Have Internal Pacemakers" on page 4-10).

• Connect ECG cable and select a lead other than

• Print ECG in Diagnostic mode (see "How to Print a Current Report" on page 7-10).

PADDLES.

4-13

Acquiring a 12-Lead ECG

Intended Use

The 12-lead ECG offers paramedics and emergency physicians significant advantages over the single lead ECG trace typically available in EMS. The 12-lead ECG not only provides a diagnostic quality ECG for use in the detection of ST elevation myocardial infarction (STEMI), but also allows the knowledgeable paramedic to determine the area of myocardial injury, anticipate associated potential complications, and implement treatment strategies accordingly. In addition, the 12-lead ECG provides a baseline for serial ECG evaluations.

The 12-lead ECG transmission to the emergency department (ED) is recommended by the AHA and ERC for patients with Acute Coronary Syndrome (ACS). When transmitted from the field, 12-lead ECG has been shown to shorten time to in-hospital treatment by an estimated 10 to 60 minutes. Patients may also benefit from triage and transport to the most appropriate facility. Documentation of transient or intermittent arrhythmias and other electrophysiologic events that occur in the prehospital setting can assist in diagnosis and treatment decisions in the ED.

Indications

The 12-lead electrocardiogram is used to identify, diagnose, and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute STelevation myocardial infarction (STEMI).

Contraindications

None known.

12-Lead ECG Warning

WARNING

POSSIBLE INABILITY TO OBTAIN A DIAGNOSTIC 12-LEAD ECG

Using previously unpackaged electrodes or electrodes past the Use By date may impair ECG signal quality. Remove electrodes from a sealed package immediately before use and follow the procedure for applying the electrodes.

Identifying Electrode Sites

To obtain a 12-lead ECG, place the electrodes on the limbs and the chest (precordium) as described in the following paragraph.

4-14

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

RA/R

LA/L

LL/FRL/N

AHA Labels IEC Labels RA Right Arm R Right LA Left Arm L Left RL Right Leg N Negative LL Left Leg F Foot

LEAD LOCATION

V1 C1 Fourth intercostal space to the right of the sternum

V2 C2 Fourth intercostal space to the left of the sternum

V3 C3 Directly between leads V2/C2 and V4/C4

V4 C4 Fifth intercostal space at midclavicular line

V5 C5 Level with V4/C4 at left anterior axillary line

V6 C6 Level with V5/C5 at left midaxillary line

Angle of Louis

Limb Lead Electrode Sites

When acquiring a 12-lead ECG, limb lead electrodes are typically placed on the wrists and ankles as shown in Figure 4-4. The limb lead electrodes can be placed anywhere along the limbs. Do not place the limb lead electrodes on the torso when acquiring a 12-lead ECG.

Figure 4-4 Limb Lead Electrode Placement for 12-Lead ECG

Precordial Lead Electrode Sites

The six precordial (chest) leads are placed on specific locations as shown and summarized in Figure 4-5. Proper placement is important for accurate diagnosis and should be identified as follows: leads are V1 through V6 for AHA, or C1 through C6 for IEC. See ECG Leads Color Codes on page 4-10 for color codes.

Figure 4-5 Precordial Lead Electrode Placement

Locating the V1/C1 position (fourth intercostal space) is critically important, because it is the reference point for locating the placement of the remaining V/C leads.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-15

To locate the V1/C1 position:

Protective flap

(open)

Limb lead

attachment

Precordial lead

attachment

1. Place your finger at the notch in the top of the sternum.

2. Move your finger slowly downward about 3.8 centimeters (1.5 inches) until you feel a slight horizontal ridge or elevation. This is the Angle of Louis where the manubrium joins the body of the sternum.

3. Locate the second intercostal space on the patient’s right side, lateral to and just below the Angle of Louis.

4. Move your finger down two more intercostal spaces to the fourth intercostal space, which is the V1/C1 position.

5. Continue locating other positions from V1/C1 (see Figure 4-5).

Other important considerations:

• When placing electrodes on female or obese patients, always place leads V3-V6 and C3-C6 under the breast rather than on the breast.

• Never use the nipples as reference points for locating the electrodes for men or women patients, because nipple locations vary widely.

12-Lead ECG Procedure

To acquire a 12-lead ECG:

1. Press

ON.

2. Insert the limb lead and the precordial lead attachments into the main cable as shown in Figure 4-6.

Figure 4-6 12-Lead ECG Cable

3. Insert the cable connector into the green ECG connector on the monitor.

4. Prepare patient’s skin for electrode application (see page 4-9).

5. Apply ECG electrodes (see page 4-15).

4-16

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

6. Encourage the patient to remain as still as possible.

WARNING

POSSIBLE INACCURATE DIAGNOSIS

If age and sex are not entered when a 12-lead ECG is obtained, the interpretive statements are based on a default of a 50-year-old male and may provide incorrect analysis for that patient.

MONITORING

7. Press

8. The

The monitor acquires, analyzes, and automatically prints the 12-lead ECG. An ECG leads-off condition for any lead is indicated on the report by a dashed line.

12-LEAD. The 12-LEAD / AGE menu appears, prompting you to enter the patient’s age.

Use the or younger. If you do not enter an age, the default value of 50 years is used by the interpretive analysis program and annotated on the 12-lead ECG report.

Use the used by the interpretive analysis program and is annotated on the 12-lead ECG report.

SPEED DIAL to select the age. Always enter the patient’s age if the patient is 15 years old

12-LEAD / SEX menu appears, prompting you to enter the patient’s sex.

SPEED DIAL to select the patient’s sex. If you do not enter the sex, the default of male is

Note: If 15 years or less is entered for patient age, the 12-lead ECG prints at diagnostic frequency

response of 0.05–150 Hz, even when 0.05–40 Hz is set up as the print default.

Note: When 12-LEAD is pressed, internal pacemaker detection is automatically enabled, even if the

function is set up to be OFF.

ECG Override

If the monitor detects signal noise while acquiring data (such as patient motion or a disconnected electrode), the screen displays the message: remains and 12-lead ECG acquisition is interrupted until noise is eliminated. Take appropriate action to eliminate the signal noise. This message remains as long as signal noise is detected. When signal noise is eliminated, the monitor resumes acquiring data. To override the message and acquire the 12-lead ECG in spite of the signal noise, press acquired and printed with no interpretive statements. Any 12-lead ECG report acquired in this way is annotated with the following statement:

NOISY DATA! PRESS 12-LEAD TO ACCEPT. The message

12-LEAD again. The 12-lead ECG will be

ECG OVERRIDE: DATA QUALITY PROHIBITS INTERPRETATION.

If the signal noise persists for longer than 30 seconds, 12-lead ECG acquisition stops. The screen displays acquisition.

EXCESSIVE NOISE–12-LEAD CANCELLED. You must then press 12-LEAD to restart 12-lead ECG

Note: If 12-LEAD is pressed immediately after ECG electrodes are applied, the message NOISY DATA

may occur. This message is due to the temporary instability between the electrode gel and the patient’s skin that is not viewable on the ECG monitor screen, but is detected as noisy data. In

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-17

general, it is best to wait at least 30 seconds after applying the last electrode before pressing the

12-LEAD button, to allow for electrode/skin stabilization. Also, good skin preparation shortens the

stabilization time.

Computerized ECG Analysis

Computerized ECG analysis statements are automatically printed on 12-lead ECG reports. Printing of the interpretive statements is a setup option and may be turned off in Setup mode. For information on how to change this setup option, see the LIFEPAK 15 Monitor/Defibrillator Setup Options provided with your device.

The interpretative statements pertaining to myocardial injury, infarct, and ischemia are derived from measurements made on a signal-averaged beat (median beat) formed for each of the 12 leads. The computerized ECG analysis selects three representative beats from the ten seconds of data for each lead and averages the three beats to derive the median beat for that lead. The ECG analysis is always based on ECG data obtained at 0.05–150 Hz frequency response.

The analysis program is adjusted for patient age and sex. The 12-lead ECG interpretive algorithm used by the LIFEPAK 15 monitor/defibrillator is the University of Glasgow 12-Lead ECG Analysis Program. For more information, contact your Physio-Control representative for a copy of the Physio- Control Glasgow 12-Lead ECG Analysis Program Physician’s Guide.

WARNING

POSSIBLE INCORRECT TREATMENT WITH REPERFUSION THERAPY

Computerized ECG interpretive statements should not be used to withhold or prescribe patient treatment without review of the ECG data by qualified medical personnel. All 12-lead ECG interpretation statements provided by the LIFEPAK 15 monitor/ defibrillator include the printed message **UNCONFIRMED**. Always confirm interpretive statements by over-reading the ECG data.

Printed 12-Lead ECG Report Formats

Two 12-lead ECG report formats are available for printing: 3-channel or 4-channel. In addition, each of those formats can be printed in standard and cabrera styles.

The 3-Channel Format

The 3-channel format prints 2.5 seconds of data for each lead. Figure 4-7 is an example of a 12-lead ECG report printed in the 3-channel format, standard style. Figure 4-8 is an example of a 12-lead ECG report printed in the 3-channel format, cabrera style. The sequence in which the limb leads are presented differs between the standard and cabrera styles, as shown. The default format for printing 12-lead ECG reports is 3-channel standard. To change the printed format of

4-18

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

Standard

measurement

Frequency

response

ECG

size

Printer

speed

Device

number

Site

number

Software

version

Serial

number

Time/date

12-lead acquired

Computerized

ECG analysis

Patient

Configuration

code

Lead

annotation

1 mV

reference

Report type and number

Name: Lee, William

Record ID: Patient ID: Incident: Age: 50

041495091422

528760224

BF382

Sex: M

12-Lead 1

HR 78 bpm

24 Apr 08 PR 0.170s QT/QTc P-QRS-T Axes

Abnormal ECG ** Unconfirmed** *** MEETS ST ELEVATION MI CRITERIA ***

Sinus rhythm Anteroseptal ST elevation, CONSIDER

ACUTE INFARCT

aVR

aVL

aVF

QRS 0.094s

Name: Lee, William

Record ID: Patient ID: Incident: Age: 50

12-Lead 1 HR 78 bpm

Abnormal ECG ** Unconfirmed** *** MEETS ST ELEVATION MI CRITERIA***

Sinus rhythm Anteroseptal ST elevation, CONSIDER

ACUTE INFARCT 24 Apr 08 PR 0.170s QT/QTc P-QRS-T Axes

aVL

-aVR

aVF

Sex:M

QRS 0.094s

12-lead ECG reports, see the LIFEPAK 15 Monitor/Defibrillator Setup Options provided with your device. Alternatively, press

FORMAT.

OPTIONS, select PRINT, select REPORT: 12-LEAD, and then select

Figure 4-7 Example of Printed 3-Channel, Standard 12-Lead ECG Report

Figure 4-8 Example of Printed 3-Channel, Cabrera 12-Lead ECG Report

The 4-Channel Format

Figure 4-9 and Figure 4-10 are examples of 12-lead ECG reports printed in the 4-channel format. The 4-channel format consists of the median complex (or median beat) derived for each of the 12 leads and 10 seconds of data for Lead II.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-19

Note: The fiducial marks displayed in the 4-channel format identify the measurement intervals

Fiducial marks

Name: Lee, William

Record ID: Patient ID: Incident: Age: 50

Sex: M

12-Lead 1

P-QRS-T Axes

24 Apr 08 PR .168s QT/QTc

HR 78 bpm

QRS 0.104s

Abnormal ECG **Unconfirmed** ***Meets ST ELEVATION MI CRITERIA***

Sinus rhythm Anteroseptal ST elevation, CONSIDER ACUTE INFARCT

aVR

aVL

aVF

Record ID: Patient ID: Incident: Age: 50

Sex: M

12-Lead 1 24 Apr 08 PR .168s QT/QTc P-QRS-T Axes

Abnormal ECG **Unconfirmed** ***Meets ST ELEVATION MI CRITERIA***

Sinus rhythm Anteroseptal ST elevation, CONSIDER ACUTE INFARCT

Name:

Lee, William

HR 89 bpm

QRS 0.104s

aVL

-aVR

aVF

used for the interpretive statements of the analysis program. These marks are part of the analysis program and cannot be turned off.

Figure 4-9 Example of Printed 4-Channel, Standard 12-Lead ECG Report

Figure 4-10 Example of Printed 4-Channel, Cabrera 12-Lead ECG Report

Printed 12-Lead ECG Frequency Response

The 12-lead ECG can be printed in two diagnostic frequency responses (or bandwidths):

0.05–40 Hz and 0.05–150 Hz. The frequency response of 0.05–150 Hz is the Association for the Advancement of Medical Instrumentation (AAMI) standard for diagnostic ECGs. The 0.05–40 Hz setting preserves the low frequency limit that is needed for the diagnosis of myocardial ischemia and infarction while reducing high frequency artifact (in particular from patient muscle tension) to help make the diagnostic printout less noisy and more readable.

4-20

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

Note: The LIFEPAK 15 monitor/defibrillator acquires ECG data and performs the interpretive

analysis based on the full frequency of 0.05–150 Hz. The 0.05–40 Hz bandwidth affects only the printed appearance of the ECG data.

The 12-lead ECG printed in the 0.05–40 Hz setting can be used to diagnose acute myocardial ischemia and ST-segment elevation myocardial infarction (STEMI). This is because the low frequency limit of 0.05 Hz is not changed from the standard diagnostic setting of 0.05–150 Hz. The 0.05 Hz frequency provides accurate representation of low frequency signals, that is, the P, ST segment, and T waves. The presence or absence of ST segment changes indicative of myocardial ischemia or infarction will be accurately reproduced. In addition, the criteria for visual analysis and interpretation of cardiac rhythm and PR, QRS, and QT intervals are preserved, as is true with hospital cardiac monitors that have an upper frequency limit of 40 Hz.

However, in some adult patients, the amplitude (that is, voltage) of the QRS may be reduced when 12-lead ECGs are printed at the upper limit of 40 Hz rather than at 150 Hz. Therefore, certain diagnoses, which depend on R wave amplitude (for example, ventricular hypertrophy), should not be made using this setting. In the pediatric patient, this effect on R wave amplitude is particularly noticeable because QRS durations in children are typically quite narrow. Because R wave amplitude reduction is more likely with pediatric patients, the 12-lead ECG automatically prints at 0.05–150 Hz, overriding the 40 Hz limit, when a patient age of 15 years or younger is entered.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-21

Troubleshooting Tips

Table 4-3 Troubleshooting Tips for the 12-Lead ECG

OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION

Any of these messages displayed:

CONNECT ECG LEADS ECG LEADS OFF XX LEADS OFF

Noisy signal and/or message displayed:

NOISY DATA! PRESS 12-LEAD TO ACCEPT

One or more ECG electrodes disconnected

ECG cable is not connected to monitor

Poor electrode-skin contact

Broken lead wire • Select another lead.

Noise in a lead other than the displayed lead

Poor electrode-skin contact

• Confirm ECG electrode connections.

• Confirm ECG cable connections.

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

• Secure trunk cable clasp to patient’s clothing.

• Prepare skin and apply new electrodes.

• Select

• Check ECG cable continuity.

•Press 12-LEAD again to override the

• Reposition cable or lead wires to prevent

• Secure trunk cable clasp to patient’s

• Prepare skin and apply new electrodes.

PADDLES lead and use standard

paddles or therapy electrodes for ECG monitoring.

message. Examine the printout to determine leads affected by noise. Replace or reposition the affected electrodes and lead wires.

electrodes from pulling away from patient.

clothing.

4-22

Loose connection • Check or reconnect cable connections.

Patient motion • Encourage patient to lie quietly.

• Support patient’s limbs.

Vehicle motion • Stop vehicle while acquiring 12-lead ECG

data.

Outdated, corroded, or dried-out electrodes

Radio Frequency Interference (RFI)

Damaged cable or connector/lead wire

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

• Check Use By date on electrode packages.

• Use only unexpired silver/silver chloride electrodes. Leave electrodes in sealed pouch until time of use.

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

• Inspect main cable and attachments. Replace if damaged.

Table 4-3 Troubleshooting Tips for the 12-Lead ECG (Continued)

OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION

MONITORING

Monitor does not complete 12-lead ECG operation sequence

Noisy signal and message displayed:

EXCESSIVE NOISE– 12-LEAD CANCELLED

Baseline wander (low frequency/high amplitude artifact)

Fine baseline artifact (high frequency/low amplitude)

For general troubleshooting tips, see Table 9-2 on page 9-18.

Operator pressed another function button (such as

PRINT) before 12-lead

ECG sequence completed

Signal noise for more than 30 seconds

Inadequate skin preparation

Poor electrode-skin contact

Inadequate skin preparation

Isometric muscle tension in arms/legs

•Press ECG. Allow enough time for sequence to complete.

•Press 12-LEAD to acquire another 12-lead ECG.

• Prepare skin as described on page 4-8 and apply new electrodes.

• Check electrodes for proper adhesion.

• Prepare skin as described on page 4-9 and apply new electrodes.

• Confirm that limbs are resting on a supportive surface.

• Check electrodes for proper adhesion.

12-LEAD to acquire another 12-lead

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-23

Monitoring SpO2, SpCO, and SpMet

SpO2, SpCO™, and SpMet™ are optional features for the LIFEPAK 15 monitor/defibrillator. When all three options (SpO oxygen saturation (SpO concentration (SpMet) in the blood.

, SpCO, and SpMet) are installed, the pulse oximeter measures functional

), carboxyhemoglobin concentration (SpCO), and methemoglobin

IMPORTANT! SpO

for use. Masimo monitor. Masimo Rainbow™ sensors are necessary to monitor SpO sensors are not compatible with other LIFEPAK defibrillator/monitors.

For a list of Masimo sensors and connector cables that are intended for use with the LIFEPAK 15 monitor/defibrillator, see the Physio-Control web site. Carefully read the Directions for Use that are provided with the sensors and connector cables for a complete description, instructions, warnings, cautions, and specifications. To order sensors and connector cables, contact your Physio-Control representative or order online at store.physio-control.com.

-only sensors and combination SpO2, SpCO, and SpMet sensors are available

SpO2-only sensors that have a red connector are compatible with the LIFEPAK 15

, SpCO, and SpMet. These

Intended Use

A pulse oximeter is a noninvasive device that continuously measures functional oxygen saturations (SpO

), carboxyhemoglobin concentration (SpCO), and methemoglobin concentration (SpMet) in

the blood. Continuously monitoring SpO decreasing and can help the clinician act rapidly before the patient develops the later signs of hypoxemia. Previously, the blood parameters SpCO and SpMet could only be obtained from invasive blood gas samples. This new technology assists in identifying the often hidden conditions of carboxyhemoglobinemia (carbon monoxide poisoning) and methemoglobinemia (a condition that impedes delivery of oxygen to the tissues). Low levels of both SpCO and SpMet are normally found in the blood; however, early detection of significantly high levels can lead to proper diagnosis and treatment, and can help improve patient outcome.

can provide an early warning when oxygen saturation is

Pulse oximetry is a tool to be used in addition to patient assessment. Care should be taken to assess the patient at all times; do not rely solely on the SpO a trend toward patient deoxygenation is evident or carbon monoxide poisoning or methemoglobinemia is suspected, blood samples should also be analyzed using laboratory instruments to completely understand the patient’s condition.

Do not use the pulse oximeter to monitor patients for apnea.

4-24

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

, SpCO, and SpMet measurements. If

MONITORING

Indications

Pulse oximetry is indicated for use in any patient who is at risk of developing hypoxemia, carboxyhemoglobinemia, or methemoglobinemia. SpO motion and motion conditions, and in patients who are well or poorly perfused. SpCO and SpMet accuracies have not been validated under motion or low perfusion conditions.

Contraindications

None known.

monitoring may be used during no

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-25

SpO2, SpCO, and SpMet Warnings and Cautions

WARNINGS

SHOCK OR BURN HAZARDS

SHOCK OR BURN HAZARD

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

SHOCK OR BURN HAZARD

Using other manufacturers’ sensors or cables may cause improper oximeter performance and invalidate safety agency certifications. Use only sensors and cables that are specified in these operating instructions.

INACCURATE READINGS HAZARDS

INACCURATE PULSE OXIMETER READINGS

Do not use a damaged sensor or cable. Do not alter the sensor or cable in any way. Alterations or modification may affect performance and/or accuracy. Never use more than one cable between the pulse oximeter and the sensor to extend the length.

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, 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.

INACCURATE PULSE OXIMETER READINGS

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

POSSIBLE 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.

4-26

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

Sensor (holds LEDs and detector)

Red

Infrared

Light-emitting diodes

Light-receiving detector

Cable

WARNINGS (CONTINUED)

POSSIBLE STRANGULATION

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

CAUTIONS

EQUIPMENT HAZARDS

POSSIBLE EQUIPMENT DAMAGE

To avoid damage to the cable, always hold by the connector rather than the cable, when connecting or disconnecting either end.

POSSIBLE EQUIPMENT DAMAGE

Do not soak or immerse the sensors or cables in any liquid solution. Do not attempt to sterilize.

No Implied License

Possession or purchase of the pulse oximeter does not convey any expressed or implied license to use the pulse oximeter with unauthorized sensors or cables which would, alone or in combination with this device, fall within the scope of one or more of the patents relating to this device.

How a Pulse Oximeter Works

A pulse oximeter sensor directs light through a patient’s fleshy body site (usually a finger or toe). The sensor sends wavelengths of light from the emitter to the receiving detector as shown in Figure 4-11.

Figure 4-11 How a Pulse Oximeter Works

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-27

The pulse oximeter translates the amount of light received by the detector to the various forms of hemoglobin saturation levels and displays them as SpO values for SpO 9% (the higher range of normal is often seen in smokers). Normal values for SpMet are typically less than 2% and may be caused by exposure to some pharmaceuticals including local anesthetic agents and chemical agents such as nitrites.

typically range from 95% to 100%. Normal values for SpCO are typically less than

, SpCO, and SpMet percentages. Normal

SpO2, SpCO, and SpMet Monitoring Considerations

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

Use the following criteria to select the appropriate pulse oximeter sensor:

• Patient size (adult, pediatric, infant) and 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 performance:

• Use a dry and appropriately sized sensor.

• Choose a site that is well perfused. The ring finger is preferred.

• Choose a site that least restricts patient movement, such as finger of the non-dominant hand.

• Be sure the fleshy part of the digit completely covers the detector.

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

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

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

Sensor Application

The preferred site for sensor application is the ring finger of the non-dominant hand. To position the sensor:

1. Orient the sensor so the cable is on the back of the patient’s hand.

2. Place the finger in the sensor until the tip of the finger touches the “raised digit stop.”

4-28

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

3. The hinged tabs of the sensor should open to evenly distribute the grip pressure of the sensor along the length of the finger. Check the arrangement of the sensor to verify correct positioning. Complete coverage of the detector window is needed to ensure accurate data.

The sensors are sensitive to light. If excessive ambient light is present, remove or reduce lighting, cover the sensor site with an opaque material to block the light, and check appropriateness of sensor site. Failure to do so could result in inaccurate measurements.

If excessive movement presents a problem during SpCO/SpMet monitoring, consider the following possible solutions:

• Be sure the sensor is secure and properly aligned.

• Use a disposable adhesive sensor.

• 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 oximeter readings.

Note: Circulation distal to the sensor site should be checked routinely.

IMPORTANT! Masimo Rainbow sensors are necessary to monitor SpCO and SpMet and are not

compatible with other LIFEPAK defibrillator/monitors.

Oximeter Monitoring Procedure

Power to the pulse oximeter is controlled by the LIFEPAK 15 monitor/defibrillator. When the defibrillator is turned on, the oximeter turns on and performs a calibration and self-test that requires approximately 20 seconds. During the calibration and self-test, the screen does not display SpO

, SpCO, or SpMet information.

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 SpO oximeter performs a self-test and then returns to normal mode.

The pulse oximeter measures and displays SpO than 50% are displayed as <50. When SpO measurements are accurate ±3 digits. The pulse oximeter measures and displays SpCO in the range of 0–40% with accuracy of ±3 digits. The pulse oximeter measures and displays SpMet in the range of 0–15% with accuracy of ± 1 digit.

, SpCO, or SpMet information. When a sensor or patient signal is detected, the

levels between 50 and 100%. SpO2 levels less

levels are between 70 and 100%, oximeter

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-29

To monitor SpO2:

1. Press

ON.

2. Connect the pulse oximeter cable to the monitor and sensor.

3. Attach the sensor to the patient.

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

5. Confirm that the SpO

6. Use the

SPEED DIAL to adjust volume, sensitivity, and averaging time, as necessary.

reading appears and is stable.

To monitor SpCO or SpMet:

1. Perform Step 2 through Step 5 above.

2. Verify that an SpCO/SpMet sensor is in use. Only Rainbow sensors are capable of reading SpCO/ SpMet.

3. Encourage the patient to remain still.

4. To quickly obtain SpCO or SpMet value, press

PRINT. If dashes (---) appear on printout instead of

values for SpCO or SpMet, allow a few more seconds for measurement to be obtained.

To display SpCO or SpMet:

•Use the

•Select

SPEED DIAL to select the SpO

PARAMETER from menu.

area.

•Select

SPCO or SPMET. Selected value displays for 10 seconds.

Note: SpCO and SpMet monitoring are not intended for use under patient motion or low perfusion

conditions.

SpCO/SpMet Advisory

If the SpCO or SpMet reading is above normal limits, indicating a dangerous amount of carboxyhemoglobin or methemoglobin, an Advisory occurs.

During an Advisory:

• The elevated SpCO or SpMet value is displayed instead of SpO

• The elevated value flashes and the alarm tone sounds.

• One of the following Advisory messages appears in the message area:

Advisory: SpCO > 10%

Advisory: SpMet > 3%

4-30

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

1. Rotate the SPEED DIAL to outline the SpO2 area on the Home Screen.

2. Press the

SPEED DIAL.

3. Highlight and select

SPO2 VOLUME.

4. Rotate the

SPEED DIAL to the desired

volume.

5. Press the

SPEED DIAL to set the volume.

SpO2_SpCo_SpMet

Parameter SpO2 Volume Sensitivity Averaging Time

SpO2

Normal 8 Seconds

To cancel the Advisory, press ALARMS. The SpO2 area reverts to the SpO2 reading. The Advisory message remains on the screen until the elevated value returns to within normal limits or the device is turned off.

WARNING

INACCURATE SPO2 READINGS

Carboxyhemoglobin and methemoglobin may erroneously increase SpO2 readings. The amount that SpO carboxyhemoglobin or methemoglobin that is present.

The Pleth Waveform

You can display the plethysmographic (pleth) waveform in Channel 2 or 3.

To display the pleth waveform:

increases is approximately equal to the amount of

1. Rotate the

2. Press the

3. Select The waveform is automatically sized for optimum waveform viewing.

SPEED DIAL to outline waveform CHANNEL 2 or 3.

SPEED DIAL. The Channel menu appears.

WAVEFORM and then select SPO2. The SpO

waveform appears in the selected channel.

Volume

To adjust the pulse tone volume:

Sensitivity

The sensitivity setting allows you to adjust the oximeter to either NORMAL or HIGH for differing perfusion states.

To adjust sensitivity:

1. Outline and select the SpO

2. Select

SENSITIVITY and then select NORMAL or HIGH.

area on the Home Screen.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-31

Note: NORMAL sensitivity is recommended for most patients. The HIGH sensitivity setting allows

SpO

monitoring under low perfusion states, such as the severe hypotension of shock. However,

when SpO patient closely when using the

sensitivity is set to HIGH, the signal is more susceptible to artifact. Monitor the

HIGH sensitivity setting.

Averaging Time

Averaging time allows you to adjust the time period that is used to average the SpO2 value.

To adjust averaging time:

1. Outline and select the SpO

2. Select

AVERAGING TIME and then select one of the following:

• 4 Seconds

• 8 Seconds

•12 Seconds

•16 Seconds

area on the Home Screen.

Note: Averaging time of 8 seconds is recommended for most patients. For patients with rapidly

changing SpO artifact is affecting the performance of the pulse oximeter.

values, 4 seconds is recommended. Use a 12- or 16-second time period when

Cleaning

Pulse oximetry sensors may be adhesive (single-patient use) or reusable.

To clean the reusable sensor and connector cable:

1. Disconnect the sensor and cable from the monitor. Inspect the cable for damage.

2. Use a clean, soft cloth dampened with 70% isopropyl alcohol to wipe clean.

3. Allow to dry thoroughly before placing the sensor on a patient or reconnecting the cable to the monitor.

Note: Do not attempt to sterilize. Do not soak or immerse in any liquid solution. For information

about cleaning the device, see "Cleaning the Device" on page 9-15.

4-32

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

Troubleshooting Tips

Table 4-4 Troubleshooting Tips for SpO2, SpCO, and SpMet

OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION

The monitor measures a pulse, but there is no oxygen saturation or pulse rate

or pulse rate changes

SpO

rapidly, pulse amplitude is erratic

SPO2: NO SENSOR DETECTED

message appears

Excessive patient motion • Keep patient still.

• Check that sensor is secure.

• Relocate sensor.

• Apply adhesive sensor.

Patient perfusion may be too low

Excessive patient motion • Keep patient still.

An electrosurgical unit (ESU) may be interfering with performance

Sensor may be damp • Replace sensor.

Sensor not connected to patient or cable disconnected from monitor/defibrillator

• Check patient.

• Increase sensitivity.

• Check that sensor is secure.

• Relocate sensor.

• Apply adhesive sensor.

• Increase sensitivity.

• 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.

• Check that sensor and cable are connected properly.

• Check that appropriate sensor is in use.

No SpO value (---) is displayed

, SpCO, or SpMet

Damaged cable or sensor • Replace damaged cable or

sensor.

Oximeter may be performing self-calibration or self-test

Defibrillator shock just delivered

High intensity lights (such as pulsating strobe lights) may be interfering with performance

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

• Wait for completion.

• If values do not display within 30 seconds, disconnect and reconnect sensor. If values do not display within another 30 seconds, replace sensor.

• None. If values do not display within 30 seconds, disconnect and reconnect sensor. If values do not display within another 30 seconds, replace sensor.

• Cover sensor with opaque material, if necessary.

4-33

Table 4-4 Troubleshooting Tips for SpO

, SpCO, and SpMet (Continued)

OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION

Damaged cable or sensor • Replace damaged cable or

sensor.

Different SpCO or SpMet measurements on same patient

XXX appears in place of SpO

reading

SPO2: CHECK SENSOR message

appears

Every measurement, even on the same patient, can be different

• Confirm by taking three measurements: ring finger, middle finger, and then index finger; average the results.

SpO2 module failed. Internal cable failed.

Sensor is disconnected from patient or cable

• Contact qualified service personnel.

• 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.

Faulty or defective sensor • Replace sensor.

Patient has a weak pulse or low blood pressure, or the sensor is not properly placed

• Change sensor location.

• Check if patient perfusion is adequate for sensor location.

• Check that sensor is secure and not too tight.

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

• Test sensor on someone else.

4-34

SPO2: UNKNOWN SENSOR

message appears

SPO2: SEARCHING FOR PULSE

message appears

SPO2: LOW PERFUSION message

appears

A sensor that is not PhysioControl approved is connected to the device.

A sensor is connected to the

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

• Wait for completion.

patient and is searching for a pulse

Patient has a weak pulse • Change sensor location.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

Table 4-4 Troubleshooting Tips for SpO

OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION

SP02: POOR QUALITY SIGNAL

message appears

SPO2: SENSOR DOES NOT SUPPORT SPCO OR SPMET

appears

message

Note: Rainbow sensor messages (SpO

For general troubleshooting tips, see Table 9-2 on page 9-18.

, SpCO, and SpMet (Continued)

When the signal quality is low, the accuracy of the measurement may be compromised

SpO

-only sensor used with

SpCO/SpMet capable device

, SpCO, and SpMet) are reported as SPO2: (MESSAGE).

• Check that sensor and cable are connected properly.

• Move sensor to a better perfused site.

• None necessary, or use Rainbow sensor to measure SpCO or SpMet.

Monitoring Noninvasive Blood Pressure

Intended Use

The LIFEPAK 15 noninvasive blood pressure (NIBP) monitor measures blood pressure (BP) using the oscillometric measurement technique to determine systolic, diastolic, and mean arterial pressures, and pulse rate. The measurement can be initiated manually or set to recur automatically at predetermined intervals.

Blood pressure measurements determined using this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation method, within the limits prescribed by the American National Standard Electronic or automated sphygmomanometers (AAMI SP-10).

NIBP is a tool to be used in addition to patient assessment. Care should be taken to assess the patient at all times; do not rely solely on the NIBP monitor.

Indications

Noninvasive blood pressure monitoring is intended for detection of hypertension or hypotension and monitoring BP trends in patient conditions such as, but not limited to, shock, acute dysrhythmia, or major fluid imbalance.

Contraindications

None known.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-35

NIBP Monitoring Warnings and Caution

WARNINGS

POSSIBLE LOSS OF INTRAVENOUS ACCESS AND INACCURATE INFUSION RATE

Do not apply the blood pressure cuff on an extremity that is used for an intravenous infusion. Patency of the intravenous infusion may be affected by blood pressure measurement due to the occlusion of blood flow.

INACCURATE READINGS HAZARDS

POSSIBLE INACCURATE BLOOD PRESSURE READINGS

Do not alter the NIBP monitor’s pneumatic tubing. Altering NIBP tubing may cause improper performance and may void the warranty. Avoid compression or restriction of pressure tubes.

POSSIBLE INACCURATE BLOOD PRESSURE READINGS

Using NIBP accessories not recommended by Physio-Control may cause the device to perform improperly and invalidate the safety agency certifications. Use only the accessories that are specified in these operating instructions.

POSSIBLE INACCURATE OXYGEN SATURATION READINGS

Do not perform NIBP measurement on an extremity used for oxygen saturation monitoring. Oxygen saturation measurement is affected by blood pressure measurement due to the occlusion of blood flow.

CAUTION

EQUIPMENT DAMAGE

Do not inflate a cuff unless it is placed on an extremity.

How NIBP Monitoring Works

The NIBP monitor uses the oscillometric measurement technique. The oscillometric technique does not use Korotkoff sounds to determine blood pressure; rather, it monitors the changes in pressure pulses that are caused by the flow of blood through the artery. The NIBP monitor inflates the cuff around the patient’s arm to a value that occludes the artery, and then deflates the cuff in steps. When blood starts to flow through the artery, the increasing blood flow causes the amplitude of the pressure pulses in the cuff to increase. As the NIBP monitor steps the pressure down, the pulses reach a peak amplitude and then start to decrease. The rising and falling amplitude values form a curve that is analyzed to yield systolic pressure, diastolic pressure, and mean arterial pressure (MAP).

4-36

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

The NIBP monitor measures the pulse rate by tracking the number of pulses over time. The NIBP monitor uses artifact rejection techniques to provide accurate results under most operating conditions. When a patient is experiencing arrhythmias during a measurement, the accuracy of the pulse determination may be affected or the time needed to complete a measurement may be extended. In shock conditions, the low amplitude of blood pressure waveforms makes it difficult for the monitor to accurately determine the systolic and diastolic pressures.

NIBP Monitoring Considerations

As with any noninvasive oscillometric blood pressure monitor, clinical conditions can affect the accuracy of the measurements obtained, including the following:

• The patient’s physiological condition. For example, shock may result in a blood pressure waveform that has a low amplitude, making it difficult for the monitor to accurately determine the systolic and diastolic pressures.

• The position of the patient.

• Motion may prolong the measurement process since motion artifacts have to be rejected in the data stream. Motion that affects measurement can include patient movement, patient seizure, bumping the cuff, and flexing the extremity under the cuff.

• The presence of other medical devices. The NIBP monitor does not operate effectively if the patient is connected to a heart/lung machine.

• When a patient is experiencing arrhythmias, pulse rate accuracy may be affected or the time needed to complete an NIBP measurement may be extended. The device automatically deflates if a blood pressure measurement cannot be obtained in 120 seconds.

• Blood pressure and pulse can fluctuate greatly between measurements; the monitor cannot alert the operator of changes in vital signs that occur between measurement cycles.

• There may be some difference between readings taken manually and readings from the NIBP monitor due to the differing sensitivity of the two methods. The NIBP monitor meets the ANSI/ SP10 AAMI standard that requires a mean difference of ±5 mmHg, with a standard deviation no greater than 8 mmHg, compared to auscultatory readings.

• When using the NIBP monitor during defibrillation, the NIBP monitor is not available when the defibrillator is being charged. Upon shock, the monitor resets and dashes (– – –) appear in place of pressure readings. After defibrillation, you can resume blood pressure measurement according to "NIBP Monitoring Procedure" on page 4-38.

• If the blood pressure cuff fails to deflate for any reason or causes undue discomfort to the patient, remove the cuff from the arm or disconnect the tubing from the defibrillator.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-37

Cuff Selection

1. Rotate the SPEED DIAL to outline the NIBP area.

2. Press the

SPEED DIAL. The NIBP menu

appears.

3. Select

INITIAL PRESSURE.

4. Rotate the

SPEED DIAL to the desired

pressure.

5. Press the

SPEED DIAL to set the initial

pressure.

NIBP

Start Interval Initial Pressure

Off 160 mmHg

The use of properly designed and sized cuffs is essential for the accurate measurement of blood pressure. The cuff must fit snugly around the extremity to occlude the artery. For a list of BP cuffs that are intended for use with the LIFEPAK 15 monitor/defibrillator, see the LIFEPAK 15 Monitor/ Defibrillator Accessories Catalog at store.physio-control.com.

NIBP Monitoring Procedure

The NIBP monitor inflates an occluding cuff and determines systolic and diastolic pressures, mean arterial pressure (MAP), and pulse rate. Pressure measurements are reported in mmHg and pulse rate in beats per minute (bpm).

Both single-measurement and specified-interval (timer-controlled) methods of blood pressure reading are available.

The NIBP monitor draws power from the defibrillator. When the defibrillator is turned on, the NIBP monitor conducts a self-test that takes approximately three seconds.

IMPORTANT! The LIFEPAK 15 monitor NIBP port and tubing are not compatible or

interchangeable with the NIBP tubing that is used with other LIFEPAK monitor/defibrillators.

Changing the Initial Inflation Pressure

4-38

The initial cuff pressure should be set approximately 30 mmHg higher than the patient’s anticipated systolic pressure. The factory default initial inflation pressure for the first measurement is 160 mmHg. For pediatric patients, the initial cuff pressure may need to be lowered. Initial inflation settings are 80, 100, 120, 140, 160, or 180 mmHg.

Caution should be taken not to lower the initial pressure below the adult patient’s systolic measurement. Doing so may cause the cuff to reinflate and cause patient discomfort. For subsequent measurements, the monitor inflates approximately 30 mmHg higher than the previously determined systolic pressure.

To select an initial pressure:

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

Countdown timer—displays time until next measurement

Systolic pressure

Diastolic pressure

Mean arterial pressure (MAP)

Note: Measurement data is recorded in the LIFEPAK 15 monitor/defibrillator Vital Sign Log. For

more information about the Vital Sign Log and its use, see Chapter 7, "Data Management."

Manual Single-Measurement Procedure

The NIBP measurement typically takes 40 seconds to complete. If the measurement is not completed within 120 seconds, the cuff automatically deflates.

To obtain a manual single measurement:

1. Press

2. Select the appropriately-sized cuff and apply it snugly to the extremity.

3. Connect the tubing to the cuff and to the NIBP port on the monitor.

4. Change the initial inflation pressure, if necessary.

5. Position the extremity in a relaxed and supported position at approximately the same level as

6. Press

To cancel a measurement, press

Note: NIBP pulse rate is displayed only when ECG or SpO

ON.

the patient’s heart. Inform the patient that the cuff will inflate and cause a “big squeeze” around the arm and that the patient’s fingers may tingle.

NIBP to start the measurement, and check that the patient’s arm is not moving. When

the measurement is complete, systolic, diastolic, and mean arterial pressures are displayed.

NIBP again.

is not active.

Timer-Controlled Measurement Procedure

When the timer is set, the monitor performs recurring measurements at a fixed interval. When using timer-controlled measurement, the interval is counted from the start of the measurement to the start of the next measurement. Choices are minutes.

To take a manual measurement between timer-controlled measurements, press interval is counted from the beginning of the manual measurement.

OFF (factory default), 2, 3, 5, 10, 15, 30, and 60

NIBP. The next

Figure 4-12 NIBP Measurements and Timer

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-39

To set timer-controlled measurements:

1. Press

2. Select the appropriately-sized cuff and apply it snugly to the extremity.

3. Connect the tubing to the cuff and to the NIBP port on the monitor.

4. Rotate the

5. Press the

6. Select

7. Position the extremity in a relaxed and supported position at approximately the same level as

8. Press

To cancel a measurement in progress, press

ON.

SPEED DIAL to outline the NIBP area.

SPEED DIAL. The NIBP menu appears.

INTERVAL and then select the desired time interval.

the patient’s heart. Inform the patient that the cuff will inflate and cause a “big squeeze” around the arm and that the patient’s fingers may tingle.

NIBP to start the measurement, and check that the patient’s arm is not moving. When

the measurement is complete, systolic, diastolic, and mean arterial pressures are displayed. The countdown timer shows the time to the next automatic NIBP measurement.

NIBP again.

Note: If at any time the cuff pressure exceeds 290 mmHg or there is a system failure of the

NIBP module, timer-controlled NIBP is terminated. To reactivate, follow the Timer-Controlled Measurement Procedure.

Cleaning

To clean the cuff and pneumatic tubing:

1. Disconnect the tubing from the cuff and monitor. Use a clean, soft cloth dampened with a germicidal solution to wipe clean.

2. Inspect the tubing for cracks or kinks. If any damage is noted, replace the tubing.

3. Inspect the cuff for damage or excessive wear. If any damage is noted, replace the cuff.

4. Allow both to dry before placing the cuff on a patient or reconnecting the tubing to the monitor.

For information about cleaning the device, see "Cleaning the Device" on page 9-15.

4-40

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

Troubleshooting Tips

Table 4-5 Troubleshooting Tips for NIBP Monitoring

OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION

NIBP AIR LEAK message appears Cuff applied too loosely.

Leak in cuff/monitor pneumatic system.

NIBP FLOW ERROR message

appears

NIBP FAILED message appears The monitor cannot establish

NIBP INITIALIZING message

appears

NIBP MOTION message appears The patient extremity moved

The pneumatic system is not maintaining stable cuff pressure

zero-pressure reference

NIBP is requested and is not successful due to a 30-second reset

too much for the monitor to accurately complete the measurement

• Check cuff for snug fit on patient.

• Check that the cuff/monitor connection is secure.

• Check cuff for leaks. Do not use a cuff that exhibits a leak.

• Deflate or remove cuff.

• Check tubing for leaks.

• Replace cuff.

• Check tubing for kink or blockage.

• If this message persists, remove monitor from use and obtain service. Use another method to measure the patient’s blood pressure.

• Wait until message disappears and request NIBP.

• Have patient lie quietly with extremity relaxed and supported.

• Check that patient’s arm does not move during NIBP measurement.

NIBP OVERPRESSURE message

appears

NIBP TIME OUT message appears The monitor did not complete a

Cuff pressure exceeded 290 mmHg

measurement in 120 seconds

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

• Disconnect tubing or remove cuff.

• Avoid very rapid squeezing of the cuff.

• If this message persists, remove the cuff from use and obtain service.

• Check cuff for snug fit on patient.

• Repeat measurement.

• Try a higher initial pressure.

• If this message persists, use another method to measure the patient’s blood pressure.

4-41

Table 4-5 Troubleshooting Tips for NIBP Monitoring (Continued)

OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION

NIBP WEAK PULSE message

appears

XXX appears in place of

NIBP readings

NIBP CHECK CUFF message

appears

Unable to connect NIBP tubing to device

Cuff not deflating Internal valves fail to open • Disconnect NIBP tubing.

Cuff not inflating Cuff is not connected to the

The monitor did not detect any pulses

NIBP module failed. NIBP module failed to calibrate successfully.

The cuff is not connected to patient or device

The LIFEPAK 12 NIBP tubing connector is not compatible with the LIFEPAK 15 NIBP port

device

Leak in tubing, cuff, or connector

• Check pulses distal to the cuff.

• Check cuff for snug fit on patient.

• Contact qualified service personnel.

• Check cuff for snug fit on patient.

• Check cuff tubing connection to device.

• Obtain correct NIBP tubing that is compatible with LIFEPAK 15 monitor/ defibrillator.

• Remove cuff from patient.

• Check tubing connection to device and cuff.

• Replace NIBP tubing or cuff.

For general troubleshooting tips, see Table 9-2 on page 9-18.

4-42

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

Monitoring ETCO2

Intended Use

The end-tidal CO2 (EtCO2) monitor is a capnometric device that uses non-dispersive infrared spectroscopy to continuously measure the amount of CO present at the end of exhalation (EtCO can be used with intubated or nonintubated patients. Respiration rate is also measured and displayed in breaths per minute.

). The sample is obtained by the side stream method and

during each breath and report the amount

The EtCO assess the patient at all times; do not rely solely on the EtCO

monitor is a tool to be used in addition to patient assessment. Care should be taken to

monitor.

Indications

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

Contraindications

None known.

EtCO2 Monitoring Warnings

WARNINGS

FIRE HAZARDS

FIRE HAZARD

Before use, carefully read these operating instructions, the FilterLine directions for use, and precautionary information.

tubing

FIRE HAZARD

The FilterLine tubing may ignite in the presence of O electrosurgical devices, or high heat. Use with caution to prevent flammability of the FilterLine tubing.

FIRE HAZARD

Flammable anesthetics become mixed with the patient’s air that is sampled by the capnometer. When using the EtCO as nitrous oxide or certain other anesthetics, connect the EtCO scavenger system.

when directly exposed to laser,

monitor in the presence of flammable gases, such

gas port to a

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-43

WARNINGS (CONTINUED)

INACCURATE READINGS HAZARDS

POSSIBLE INACCURATE PATIENT ASSESSMENT

The EtCO be used as a diagnostic apnea monitor. An apnea message appears if a valid breath has not been detected for 30 seconds and indicates the time elapsed since the last valid breath. It must be used in conjunction with clinical signs and symptoms.

POSSIBLE INACCURATE CO2 READINGS

Using other manufacturers’ CO improperly and invalidate the safety agency certifications. Use only the accessories that are specified in these operating instructions.

HEALTH HAZARDS

POSSIBLE STRANGULATION

Carefully route the patient tubing (FilterLine) to reduce the possibility of patient entanglement or strangulation.

INFECTION HAZARD

Do not reuse, sterilize, or clean Microstream single-patient one-time use.

monitor is intended only as an adjunct in patient assessment and is not to

accessories may cause the device to perform

CO2 accessories as they are designed for

How Capnography Works

An EtCO2 sensor continuously monitors carbon dioxide (CO2) that is inspired and exhaled by the patient. The sensor employs Microstream non-dispersive infrared (IR) spectroscopy to measure the concentration of CO

The CO

FilterLine system delivers a sample of the exhaled gases directly from the patient into the

LIFEPAK 15 monitor for CO and secretion accumulation and prevents obstruction, which maintains the shape of the CO waveform.

The CO

sensor captures a micro sample (15 microliters). This extremely small volume allows for

fast rise time and accurate CO

The Microbeam IR source illuminates the sample cell and the reference cell. This proprietary IR light source generates only the specific wavelengths characteristic of the CO Therefore, no compensations are required when concentrations of O vapor are present in the exhaled breath.

molecules that absorb infrared light.

measurement. The low sampling flow rate (50 ml/min) reduces liquid

readings, even at high respiration rates.

absorption spectrum.

, anesthetic agent, or water

4-44

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

III

You can set up the LIFEPAK 15 monitor/defibrillator to use the capnography Body Temperature Pressure Saturated (BTPS) conversion method. This option corrects for the difference in temperature and moisture between the sampling site and alveoli. The correction formula is 0.97 × the measured EtCO your device.

EtCO2 Monitoring Waveform Analysis

Valuable information concerning the patient’s expired CO2 can be acquired by examination and interpretation of the waveform.

The Phases of the Waveform

Figure 4-13 is a graphic representation of a normal capnograph waveform. Four phases of the waveform require analysis. The flat I–II baseline segment (Respiratory Baseline) represents continued inhalation of CO Upstroke), a sharp rise, represents exhalation of a mixture of dead space gases and alveolar gases from acini with the shortest transit times. Phase III–IV (Expiratory Plateau) represents the alveolar plateau, characterized by exhalation of mostly alveolar gas. Point IV is the end-tidal (EtCO Downstroke), a sharp fall, reflects the inhalation of gases that are CO normal capnograph or EtCO ventilation, or equipment function.

) value that is recorded and displayed by the monitor. Phase IV–V (Inspiratory

value. See the LIFEPAK 15 Monitor/Defibrillator Setup Options provided with

-free gas. This value normally is zero. The II–III segment (Expiratory

-free. Alterations of the

values are the result of changes in metabolism, circulation,

Figure 4-13 Phases of the Respiratory Waveform

Respiratory Baseline Elevation of the waveform baseline (I–II segment) usually represents

rebreathing CO Rebreathing CO hypoventilation. Precipitous rises in both baseline and EtCO contamination of the sensor.

Expiratory Upstroke In the normal waveform, the rising phase (II–III segment) is usually steep.

When this segment becomes less steep, CO site. The causes of this delay can be physiologic or mechanical and include bronchospasm, obstruction of the upper airway, or obstruction (or kinking) of an endotracheal tube (ETT).

Expiratory Plateau The plateau of the waveform, which represents the remainder of expiration

(III-IV segment), should be nearly horizontal. The end of the plateau represents the EtCO Upward slanting of the expiratory plateau occurs when there is uneven emptying of the alveoli.

. This elevation usually is accompanied by gradual increases in the EtCO2 value.

is common in circumstances of artificially produced increased dead space and

values usually indicate

delivery is delayed from the lungs to the sampling

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

value.

4-45

Similar to the diminished slope of the Expiratory Upstroke, this pattern can occur in asthma, chronic obstructive pulmonary disease (COPD), partial upper-airway obstruction, or partial mechanical obstruction such as a partially kinked ETT.

Inspiratory Downstroke The fall to baseline (IV-V segment) is a nearly vertical drop. This slope

can be prolonged and can blend with the expiratory plateau in cases of leakage in the exhale portion of the breathing circuit. The peak EtCO

value (IV) is often not reached. Relying on the

numeric end-tidal value without observing the breathing waveform may obscure the presence of a leak.

EtCO2 Monitoring Procedure

When activated, the EtCO2 monitor draws power from the defibrillator. The LIFEPAK 15 monitor/ defibrillator activates the EtCO Initialization, self-test, and warm up of the EtCO may take up to two-and-one-half minutes.

CAUTION

POSSIBLE EQUIPMENT DAMAGE

Failure to replace a broken or missing CO2 port door may allow water or particulate contamination of the internal CO malfunction.

monitor when it senses the attachment of the FilterLine set.

monitor is typically less than 30 seconds, but

sensor. This may cause the CO2 module to

To monitor EtCO

1. Press

ON.

2. Select the appropriate EtCO

3. Open the CO

4. Verify that the CO

accessory for the patient.

port door and insert the FilterLine connector; turn connector clockwise until tight.

area is displayed. The EtCO2 monitor performs the autozero routine as part

of the initialization self-test.

Note: If you use a ventilation system, do not connect the FilterLine set to the patient/ventilation

system until the EtCO

5. Display CO

6. Connect the CO

waveform in Channel 2 or 3.

7. Confirm that the EtCO scale for the best visualization of the waveform. You can change the scale, if desired, as described in the next section.

monitor has completed its self-test and warm-up.

FilterLine set to the patient.

value and waveform are displayed. The monitor automatically selects the

Note: It is possible for the FilterLine set to become loose at the device connection and still have an

EtCO

value and CO2 waveform, but they may be erroneously low. Make sure the FilterLine

connection is firmly seated and tight.

4-46

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

Note: The capnography module performs self-maintenance within the first hour of monitoring and

once an hour during continuous monitoring. The self-maintenance includes “auto-zeroing.” Selfmaintenance is also initiated when the surrounding temperature changes 8°C (14.4°F) or more, or the surrounding pressure changes greater than 20 mmHg. The CO attempts to purge the tubing. To clear the messages, remove the FilterLine tubing and reconnect it to the monitor.

CO2 FILTERLINE PURGING or CO2 FILTERLINE BLOCKAGE

CO2 Display

The following scales are available to display the CO2 waveform. The LIFEPAK 15 monitor/ defibrillator automatically selects the scale based on the measured EtCO scale, outline and select the CO the scale menu.

• Autoscale (default)

• 0–20 mmHg (0–4 Vol% or kPa).

• 0–50 mmHg (0–7 Vol% or kPa).

• 0–100 mmHg (0–14 Vol% or kPa).

area using the SPEED DIAL and then select the desired scale from

module detects this change and

value. To change the CO2

The CO the 4-second screen. There is a slight delay between when the breath occurs and when it appears on the screen. Printouts are at 25 mm/sec. Continuous print may be changed to 12.5 mm/sec, if desired.

The monitor shows the maximum CO increasing, the change can be seen with every breath. However, if the values are continually decreasing, it will take up to 20 seconds for a lower numerical value to be displayed. Because of this, the EtCO

waveform is compressed (displayed at 12.5 mm/sec sweep speed) to provide more data in

value over the last 20 seconds. If the EtCO2 values are

value may not always match the level of the CO2 waveform.

CO2 Alarms

The EtCO2 monitor provides:

•EtCO

•FiCO

• Apnea alarm (automatic and not adjustable)

Note: The apnea alarm occurs when a breath has not been detected for 30 seconds. The message

ALARM APNEA appears in the message area along with the time since the last detected breath.

high and low alarms controlled by activating ALARMS (see "Alarms" on page 3-21)

(inspired CO2) alarm (automatic and not adjustable)

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-47

CO2 Detection

A CO2 waveform appears when any CO2 is detected, but CO2 must be greater than 3.5 mmHg for a numerical value to be displayed. However, the CO is at least 8 mmHg (1.0% or kPa). Valid breaths must be detected in order for the apnea alarm to function and to count the respiratory rate (RR). The RR represents an average over the last eight breaths.

module will not recognize a breath until the CO2

When CO dashes “---” or a flat solid line at or near zero—several factors must be quickly evaluated. Assess for the following causes:

Equipment issues

• Disconnection of the FilterLine set from the endotracheal tube (ETT)

• System is purging due to fluid in the patient/sensor connection from ET administration of medications

• System is auto-zeroing

• Shock was delivered and system is resetting

• Loose FilterLine set to device connection

Loss of airway function

• Improper placement of ETT

• ETT dislodgment

• ETT obstruction

Physiological factors

• Apnea • Loss of perfusion • Exsanguination

• Massive pulmonary embolism • Inadequate CPR

is not detected in the cardiac arrest situation—for example, the CO2 waveform is either

Cleaning

Accessories for CO2 monitoring are disposable and are intended for single-patient use. Do not clean and reuse a FilterLine set. Dispose of the contaminated waste according to local protocols.

For information about cleaning the device, see "Cleaning the Device" on page 9-15.

4-48

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

Troubleshooting Tips

Table 4-6 Troubleshooting Tips for EtCO2 Monitoring

OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION

ALARM APNEA message appears

and waveform is solid line at or near zero

CO2 FILTERLINE OFF message

appears and waveform is “---”

CO2 FILTERLINE PURGING

message appears and waveform is “---”

CO2 FILTERLINE BLOCKAGE

message appears and waveform is “---”

No breath has been detected for 30 seconds since last valid breath

FilterLine connection to device is loose

FilterLine set is disconnected from patient or ETT

FilterLine set disconnected or not securely connected to device

FilterLine set is kinked or clogged with fluid, or rapid altitude change occurred

The message appears after 30 seconds of unsuccessful purging

• Check the patient.

• Twist FilterLine connector clockwise until tight and firmly seated.

• Check ventilation equipment (if used) for leaks or disconnected tubing.

• Connect FilterLine set to device port.

• Twist FilterLine connector clockwise until tight and firmly seated.

• Disconnect and then reconnect the FilterLine set.

• Twist FilterLine connector clockwise until tight and firmly seated.

• Disconnect and then reconnect the FilterLine set.

• Change the FilterLine set.

CO2 INITIALIZING message

appears and waveform is “---”

AUTO ZEROING message appears

and waveform is “---”

FilterLine set is kinked or clogged

FilterLine set just connected to device

Defibrillation shock delivered • None. System resets

Module is performing selfmaintenance

Defibrillation shock delivered • None. System resets

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

• Twist FilterLine connector clockwise until tight and firmly seated.

• None.

automatically within 20 seconds.

• None.

automatically within 20 seconds.

4-49

Table 4-6 Troubleshooting Tips for EtCO

Monitoring (Continued)

OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION

EtCO2 values are erratic FilterLine connection to device

is loose

A leak in the FilterLine set • Check for connection leaks

A mechanically ventilated patient breathes spontaneously or patient is talking

values are consistently

EtCO

higher than expected

Physiological cause such as COPD

Inadequate ventilation • Check ventilator, increase

Patient splinting during breathing

Improper calibration • Contact qualified service

values are consistently

EtCO

lower than expected

FilterLine connection to device is loose

Physiological cause • See Physiological factors in

• Twist FilterLine connector clockwise until tight and firmly seated.

and line leaks to patient, and correct, if necessary.

• No action required.

• None.

ventilatory rate/bagging.

• Supporting measures such as pain relief.

personnel.

• Twist FilterLine connector clockwise until tight and firmly seated.

"CO2 Detection" on page 4-48.

4-50

waveform stays elevated

for several seconds

Sudden extreme increase in EtCO

XXX appears instead of EtCO

value

There is no EtCO

waveform is flat

value and the

Hyperventilation • Check ventilator, decrease

ventilatory rate/bagging.

Improper calibration • Contact qualified service

personnel.

Expiration is prolonged due to bagging technique

• Release bag reservoir completely with expiration. Observe that elevated baseline returns to normal level.

Fluid has entered CO2 module • Contact qualified service

personnel.

CO2 module malfunction • Contact qualified service

personnel.

Measured CO mmHg

is less than 3.5

• See "CO2 Detection" on page 4-48.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

Note: To decrease the likelihood of the FilterLine connection coming loose during use, hand-

straighten the tubing after removal from the package before connecting to patient or device.

For general troubleshooting tips, see Table 9-2 on page 9-18.

Monitoring Invasive Pressure

Intended Use

The LIFEPAK 15 invasive pressure (IP) monitor is intended for measuring arterial, venous, intracranial, and other physiological pressures using an invasive catheter system with a compatible transducer.

The IP monitor is a tool to be used in addition to patient assessment. Care should be taken to assess the patient at all times; do not rely solely on the IP monitor.

Indications

Invasive pressure monitoring is indicated for use in patients who require continuous monitoring of physiological pressures in order to rapidly assess changes in the patient’s condition or response to therapy. It may also be used to aid in medical diagnosis.

Contraindications

None known.

IP Monitoring Warnings

WARNINGS

INACCURATE READINGS HAZARDS

POSSIBLE INACCURATE PRESSURE READINGS, AIR EMBOLISM, BLOOD LOSS, OR LOSS OF STERILITY

Before use, carefully read these operating instructions, and the transducer and infusion set instructions for use and precautionary information.

INACCURATE PRESSURE READINGS

Pressure readings should correlate with the patient’s clinical presentation. If readings do not correlate, verify that the zeroing stopcock is positioned at the patient’s zero reference, rezero the transducer, and/or check the transducer with a known or calibrated pressure. Manually check cuff blood pressure.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-51

WARNINGS (CONTINUED)

INACCURATE PRESSURE READINGS

Changing the patient’s position changes the zero reference level. Relevel the transducer’s zeroing stopcock any time the patient’s position is changed.

HEALTH HAZARDS

POSSIBLE LETHAL ARRHYTHMIA

Ventricular fibrillation may be induced if the isoelectric barrier of the transducer is disrupted. The isoelectric barrier within the transducer may be disrupted if the transducer body is damaged. Do not use a transducer that is visibly damaged or leaking fluid.

INCREASED INTRACRANIAL PRESSURE

Do not use a continuous flush device with transducers used for intracranial monitoring.

IP Monitoring

Two channels are available for invasive pressure monitoring, with default labels P1 and P2 and the user-selectable labels shown in Table 4-7.

Table 4-7 IP Labels and Descriptions

LABEL DESCRIPTION

ART Arterial Pressure

PA Pulmonary Artery Pressure

CVP Central Venous Pressure

ICP Intracranial Pressure

LAP Left Atrial Pressure

When the default labels P1 and P2 are used, the IP monitoring area displays systolic, diastolic, and mean pressures. When ICP, LAP, or CVP labels are used, the IP monitoring area displays mean pressure in large type. Systolic and diastolic pressures are not displayed.

4-52

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

ART systolic pressure

ART diastolic pressure

CVP mean pressure

ART mean pressure

Figure 4-14 IP Labels

Because pressures can change in a short time, data should be checked regularly during vital sign monitoring.

How IP Monitoring Works

IP monitoring involves the conversion of fluid pressure into an electrical signal. The conversion is accomplished with a pressure transducer. The transducer is connected to a patient’s indwelling pressure catheter using a special assembly of tubing, stopcocks, adapters, flush valves, and fluids, commonly known as a flush system. The transducer translates the pressure wave into an electrical signal. A well-functioning flush system is essential for obtaining undistorted waveforms and accurate information.

IP monitoring is available on either Channel 2 or 3. The IP connector (6-pin type 3102A-14S-6S) is compatible with industry standard (60601-2-34 and AAMI-BP22) pressure transducers with 5μV/V/ mmHg sensitivity. For a list of IP transducers that are compatible with the LIFEPAK 15 monitor/ defibrillator, see the LIFEPAK 15 Monitor/Defibrillator Accessory Catalog at www.physiocontrol.com. If the use of other transducers is desired, the customer must be responsible for determining if the transducers comply with standards and are compatible with the monitor.

The IP connector pinout has the following configuration, counterclockwise from 12 o’clock, viewed from the front of the LIFEPAK 15 monitor/defibrillator.

A pin = - signal B pin = + excitation C pin = + signal

D pin = - excitation E pin = shield F pin = unlabeled

An invasive pressure adapter cable is used to connect the transducer to the monitor.

IP Monitoring Procedure

Prepare a flush system according to local protocols. Position the transducer at the patient’s phlebostatic axis (zero-reference level).

To avoid offset errors, a zero reference must be established before any meaningful pressure readings are obtained. This is done by opening the transducer stopcock to air so that atmospheric pressure becomes the reference.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-53

The P1 or P2 connector and Channel 2 or 3 can be used for IP monitoring. P1 and Channel 2 are used in these instructions.

To monitor IP:

1. Prepare the transducer system according to the operating instructions provided with the transducer and your local protocol.

2. Press

3. Connect the IP cable to the transducer and to the P1 port on the monitor.

4. Use the default label

5. Use the

6. Open the transducer’s stopcock to air to zero the transducer and remove stopcock cap. Select

7. Close the stopcock to air. The patient’s pressure waveform should be displayed. A scale is

ON.

P1 or select ART, PA, CVP, ICP, or LAP. To change the label, select the P1

area. From the menu, select

SPEED DIAL to outline and select CHANNEL 2 on the Home Screen. From the Channel 2

menu, select

the

P1 area. Select ZERO from the menu. The message P1 ZEROED appears when zeroing is

complete and the pressure values are displayed as zeros.

automatically selected to display the pressure. Confirm that pressure amplitude correlates with the digital readout.

WAVEFORM and then select the label that is desired for the waveform.

P1. Select a label from the list.

Note: If you place a cap on an open port before you close the port to air, an error message may

appear. You will be required to zero the transducer again.

If pressure alarms are desired, set the alarms after you obtain a satisfactory waveform. Error or alarm messages appear in the message area at the bottom of the screen. For more information, see "Alarms" on page 3-21.

IP Scale Options

The IP monitor can display pressures from -30 to 300 mmHg. After zeroing the transducer pressure, the monitor automatically selects one of the following scales based on the patient’s measured pressure:

• -30 to 30 mmHg

•0 to 60mmHg

• 0 to 120 mmHg

• 0 to 150 mmHg

• 0 to 180 mmHg

• 0 to 300 mmHg

You can also manually select one of these scales or autoscale to readjust the waveform within the channel.

4-54

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

To change the scale:

MONITORING

1. Use the

2. From the menu, select

SPEED DIAL to outline and select the P1 area. The P1 menu appears.

SCALE and then choose a scale from the list.

Cleaning

IP transducers are disposable and are intended for single-patient use. Do not clean and reuse transducers. Dispose of the contaminated waste according to local protocols.

IP cables are reusable and may be cleaned. To clean the reusable IP cable:

1. Disconnect the cable from the monitor.

2. Use a clean, soft cloth dampened with a germicidal solution to wipe clean.

3. Allow to dry before reconnecting the cable to the monitor.

For information about cleaning the device, see "Cleaning the Device" on page 9-15.

Troubleshooting Tips

The error messages in Table 4-8 use the text PX to represent any of the labels for invasive pressure, including P1, P2, and the user-selectable labels ART, PA, CVP, ICP, and LAP.

Table 4-8 Troubleshooting Tips for IP Monitoring

OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION

Invasive pressure value is blank No transducer is connected • Connect the transducer to the

cable, and the cable to the monitor.

No scale appears next to the waveform

PX NOT ZEROED message appears The zero reference has not

PX ZERO FAILED message appears An unsuccessful attempt

Dampened waveform Loose connection • Check the entire system for

The zero reference has not been established

been established

has been made to set a zero reference value

Tubing too long or too compliant

Thrombus formation, air bubbles, or blood left in catheter after blood draw

• Zero the transducer.

• Make sure that the transducer is open to air and repeat the attempt to zero.

leaks. Tighten all connections. Replace any defective stopcocks.

• Use short, stiff tubing with a large diameter.

• Use syringe to draw back air or particles in catheter, and then flush system.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-55

Table 4-8 Troubleshooting Tips for IP Monitoring (Continued)

OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION

Kinked catheter, catheter tip against vessel wall, arterial spasm

Resonating waveform Tubing too long • Use short, stiff tubing with

No waveform. No pressure reading.

Invasive BP lower than cuff BP Transducer level higher

Transducer closed to patient

Defibrillator shock just delivered

than the heart

Loose connection • Tighten all connections.

Thrombus formation, air bubbles, or blood in catheter, kinking, or arteriospasm

Improper zero reference • Open stopcock to air and

Defective transducer • Replace transducer.

• Reposition catheter. Anchor catheter to skin at insertion site.

large diameter.

• Check patient. Check stopcock positions and monitor setup.

• None.

• Reposition transducer to correct height.

• Use syringe to draw back air or particles in catheter, and then flush system.

rezero transducer.

Invasive BP higher than cuff BP Transducer level lower than

the heart

Improper zero reference • Rezero.

Catheter whip artifact • Change catheter tip position.

Inability to flush system Pressure bag leaking • Keep positive pressure in

Partially kinked or obstructed catheter

Inability to zero system Stopcock not open to air or

defective

Defective transducer • Replace transducer.

• Reposition transducer to correct height.

• Use mean pressure values (mean pressure is less affected by extremes and will therefore reflect a more accurate reading).

flush bag at all times.

• Remove dressing to check for external kinking.

• Replace catheter, if clotted.

• Check stopcock position. Replace any defective stopcocks.

4-56

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

Table 4-8 Troubleshooting Tips for IP Monitoring (Continued)

OBSERVATION POSSIBLE CAUSE CORRECTIVE ACTION

System has been zeroed but continues to indicate zero reference required

Catheter whip (fling) artifact Pulmonary Artery

Permanent Pulmonary Wedge Pressure (PWP) tracing (wedge tracing persists after balloon deflation)

Steps to zero system performed in wrong order

Excessive catheter movement. Motion of the catheter tip within the vessel accelerates fluid movement in the catheter, causing artifact to be superimposed on the pressure wave, increasing readings by 10–20 mmHg.

Catheter tip partially clotted • Use syringe to aspirate, and

Catheter migrated distally in pulmonary artery

• Close stopcock to air before placing cap on port.

• Change catheter tip position.

• Use mean pressure values (mean pressure is less affected by extremes and therefore reflects a more accurate reading).

then flush.

• Observe PA waveform before balloon inflation. Flattening of the waveform could indicate wedging with balloon deflated. Turn patient side to side in Trendelenburg position, or stimulate cough in attempt to dislodge catheter.

• Retract catheter with balloon deflated until proper position is obtained.

• Minimize chances of catheter advancement by firmly anchoring catheter at insertion site.

Failure to obtain PWP Malposition of catheter tip • Reposition catheter.

Leak in balloon. Ruptured balloon.

Progressive elevation of PWP Overinflation • Inflate balloon in small

Catheter migrated distally in pulmonary artery

For general troubleshooting tips, see Table 9-2 on page 9-18.

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

• Replace catheter.

increments while watching scope for confirmation of wedging. Use only enough air to wedge. Do not use more than the volume recommended by the manufacturer.

• Reposition catheter.

4-57

Vital Sign and ST Segment Trends

Intended Use

The trends feature of the LIFEPAK 15 monitor/defibrillator provides the ability to graphically display and document the patient’s vital signs (VS) and ST segment measurements for up to eight hours. VS trending is intended for use with any patient who requires continuous monitoring of vital signs over an extended period of time to identify changes in patient condition and to document patient response to therapy. ST trending is intended for use with patients suspected of having acute ischemic events, such as unstable angina, and for patients during treatment of an acute ischemic event. ST segment measurement is initiated using a 12-lead ECG and is derived using the University of Glasgow 12-Lead ECG Analysis Program.

VS and ST Trends Warning

WARNING

INACCURATE INTERPRETATION OF PATIENT STATUS

Vital sign and ST graphs are tools to be used in addition to patient assessment. Artifact and noise may produce spurious data. Ensure artifact-free monitoring as much as possible and assess the patient frequently to confirm the appropriateness of monitor data.

4-58

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

MONITORING

VS label

Most recent ETCO

measurement

First ETCO2 measurement

VS label

Systole pressure

Diastolic pressure

How VS Trends Work

Each active vital sign can be displayed graphically for time ranges of 30 minutes, and 1, 2, 4, and 8 hours. The vital signs are HR, SpO mean pressures. Data is sampled every 30 seconds. If valid data is not available, a blank space is substituted on the graph. NIBP values are plotted only when an NIBP measurement is obtained. VS measurements are not averaged or filtered. No messages or alarms occur based on changes in VS measurements.

, SpCO, SpMet, CO2, and RR; and systolic, diastolic, and

Figure 4-15 EtCO2 Trend Graph

Figure 4-16 Pressure Trend Graph

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

4-59

How ST Trends Work

STJ

ST measurements can be displayed graphically for time ranges of 30 minutes, and 1, 2, 4, and 8 hours. ST trending is initiated by obtaining the patient’s first 12-lead ECG. The ST J-point (STJ) is the part of the ST segment that is measured (see Figure 4-17). The STJ measurement is plotted on the ST trend graph (see Figure 4-18).

Figure 4-17 STJ Measurement

When all leads of the 12-lead ECG cable are attached to the patient, STJ measurements are obtained automatically every 30 seconds. If a lead is off, or the ECG data is too noisy, ST measurements are not obtained and the graph shows a blank for that time period. If an STJ measurement in any lead deviates from the initial measurement by 1 mm (0.1 mV) or more and the deviation persists for 2.5 minutes, the monitor automatically prints another 12-lead ECG.

Interpreting the ST Trend Graph

Using the first 12-lead ECG, the monitor identifies the presence of any STJ displacement, either negative or positive, and the lead that has the most STJ displacement. When lead that has the most STJ displacement is shown on the graph. The STJ is measured every 30 seconds thereafter.

Figure 4-18 shows an example of an ST trend graph. The elapsed time goes from right to left across the screen. The most current STJ measurement is on the far right. Each time an STJ measurement is obtained, it is compared to the first STJ or baseline measurement. The bars represent the change in the STJ compared to the first measurement.

AUTO is selected, the

4-60

LIFEPAK 15 Monitor/Defibrillator Operating Instructions

Physio Control Lifepak 15 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual