Edition 7
Printed in the USA
Publication number M4735-91900
The information in this guide applies to
the M4735A HeartStart XL, release
Main 20 and earlier. This information is
subject to change without notice.
Philips shall not be liable for errors contained herein or for incidental or consequential damages in connection with the
furnishing, performance, or use of this
material.
IN THE U.S., FEDERAL LAW
RESTRICTS THIS DEVICE TO
SALE ON OR BY THE ORDER
OF A PHYSICIAN.
Medical Device Directive
The M4735A HeartStart XL Defibrillator/Monitor complies with the requirements of the Medical Device Directive
93/42/EEC and carries the
mark accordingly.
For the Declaration of Conformity
Statement, please see the Philips Medi
cal web site at http://incenter.medical.philips.com/PMSPublic. Scroll over
the Quality and Regulatory Tab located
in the upper left corner of the window.
Click to select Regulatory by Modality.
Then click to select Defibrillators and
select the entry for Declaration of Con
formity (DoC).
0123
China:
After sales service: Beijing MEHECOPHILIPS Medical Equipment Service
Center
After sales service address: No. 208,
2nd District, Wang Jing Li Ze Zhong
Yuan, Chao Yang District, Beijing
Postal Code: 100102
Telephone: 010-64392415
Registration Number:
SFDA(I)20043212740
Product standard number:
YZB/USA 2764-21
Warning
Radio frequency (RF) interference from
nearby transmitting devices may
-
degrade the performance of the
M4735A HeartStart XL Defibrillator/
Monitor. Electromagnetic compatibil
ity with surrounding devices should be
assessed prior to using the defibrillator/
monitor.
The M4735A HeartStart XL Defibrillator/Monitor is designed to meet your
resuscitation and monitoring needs. This guide provides instructions for safe
and proper operation, set-up, configuration, and care of your
M4735A HeartStart XL Defibrillator/Monitor.
In this chapter, you’ll find general information that you should become familiar with before using the defibrillator/monitor.
1
M4735A HeartStart XL Defibrillator/Monitor1-1
Overview
Overview
The M4735A HeartStart XL Defibrillator/Monitor is a lightweight, portable,
semi-automatic external defibrillator. It offers two modes of operation for
defibrillation:
Both modes incorporate a low energy SMART Biphasic waveform for
defibrillation.
In AED Mode, the M4735A HeartStart XL Defibrillator/Monitor analyzes the
patient’s ECG and advises you whether or not to deliver a shock. Voice
prompts guide you through the defibrillation process by providing instruc
tions and patient information. Voice prompts are reinforced by messages that
appear on the display.
In Manual Mode, the M4735A HeartStart XL Defibrillator/Monitor turns control of the defibrillation process over to you. You assess the patient’s ECG,
and select the energy setting for defibrillation if necessary. Manual Mode also
allows you to perform synchronized cardioversion and offers
noninvasive pacing (optional).
-
Defibrillation is performed through external or internal paddles (both
optional), or through multifunction defib electrode pads. Monitoring is avail
able in AED and Manual Mode through pads, 3-lead ECG monitoring electrodes, or optional 5-lead ECG monitoring electrodes. Optional pulse
oximetry (SpO
While monitoring ECG or SpO
) monitoring is also available in AED and Manual Modes.
2
, you may set heart rate and/or SpO2 alarms to
2
alert you when these parameters are outside the defined limits.
1-2Introduction
-
Overview
The M4735A HeartStart XL Defibrillator/Monitor automatically stores critical events in its internal memory, such as shocks and alarm violations. Additional events of interest may also be marked for storage. These events can be
printed as they occur or as part of an Event Summary. The M4735A Heart
Start XL Defibrillator/Monitor also allows you to store data and events on an
optional HeartStart XL-compatible data card (see Chapter 11 for a listing) for
downloading to HeartStart Event Review Data Management Systems.
The versatile M4735A HeartStart XL Defibrillator/Monitor is highly configurable to better meet the needs of diverse users. The messages and softkeys
vary, depending on how the M4735A HeartStart XL Defibrillator/Monitor is
configured. Be sure to familiarize yourself with your configuration before
using the M4735A HeartStart XL Defibrillator/Monitor (see
HeartStart XL” on page 10-7).
The M4735A HeartStart XL Defibrillator/Monitor is powered by AC power
and a rechargeable sealed lead acid (SLA) battery which allows the defibrilla
tor to charge to 200 joules in less than three seconds. Proper care of your batteries will ensure that they have the energy required to operate the M4735A
HeartStart XL Defibrillator/Monitor and to deliver the appropriate therapy.
(See
“Battery Maintenance” on page 11-8.) Similarly, performing the specified operational checks will ensure that the M4735A HeartStart XL Defibrillator/Monitor is functioning properly and ready for use. (See “Operational
Checks” on page 11-2.)
“Configuring the
-
1
-
M4735A HeartStart XL Defibrillator/Monitor1-3
Intended Use
Intended Use
The M4735A HeartStart XL Defibrillator/Monitor is for use in the hospital by
qualified medical personnel trained in the operation of the device and quali
fied by training in basic life support, advanced cardiac life support, or
defibrillation. It must be used by or on the order of a physician.
When operating as a semi-automatic external defibrillator in AED Mode, the
M4735A HeartStart XL Defibrillator/Monitor is suitable for use by medical
personnel trained in basic life support that includes the use of an AED.
When operating as a defibrillator/monitor in Manual Mode, the M4735A
HeartStart XL Defibrillator/Monitor is suitable for use by healthcare profes
sionals trained in advanced cardiac life support.
-
-
Defibrillation Therapy
Defibrillation therapy is the definitive method for termination of a variety of
potentially fatal arrhythmias. The M4735A HeartStart XL Defibrillator/Moni
tor provides this therapy through the application of a brief biphasic pulse of
electricity to the cardiac muscle. This electrical energy is transferred through
attached internal paddles applied directly to the patient’s heart, or through
attached paddles or disposable multifunction defib electrode pads applied to
the patient’s bare chest.
-
NOTESuccessful resuscitation is dependent on many variables specific to the
patient’s physiological state and the circumstances surrounding the patient
event. Failure to have a successful patient outcome is not a reliable indicator
of defibrillator/monitor performance. The presence or absence of a muscular
response to the transfer of energy during electrical therapy is not a reliable
indicator of energy delivery or device performance.
1-4Introduction
Defibrillation Therapy
Indications for AED Therapy
An AED is to be used in the presence of a suspected cardiac arrest on patients
of at least 8 years of age that are:
zUnresponsive
zNot breathing
zPulseless
Contraindications for AED Therapy
An AED is not to be used on patients that exhibit one or any combination of
the following:
The AED algorithm is not designed to handle erratic spiking problems caused
by a properly or improperly functioning pacemaker. In patients with cardiac
pacemakers, the M4735A HeartStart XL Defibrillator/Monitor may have
reduced sensitivity and not detect all shockable rhythms.
1
NOTEThe Philips HeartStart XL AED algorithm is not intended for children under 8
years of age. For children older than 8 years, the American Heart Association
recommends that standard operating procedures for AEDs be followed.
American Heart Association Guidelines 2005 for Cardiopulmonary Resusci
-
tation and Emergency Cardiovascular Care. Dallas, Texas; AHA; 2005.
M4735A HeartStart XL Defibrillator/Monitor1-5
Defibrillation Therapy
Indications for Manual Defibrillation Therapy
Asynchronous defibrillation is the initial treatment for ventricular fibrillation
and ventricular tachycardia, in patients who are pulseless and unresponsive.
Synchronous defibrillation is indicated for termination of atrial fibrillation.
The SMART Biphasic waveform utilized in the HeartStart XL Defibrillator/
Monitor has undergone clinical testing demonstrating its effectiveness for
cardioversion of atrial fibrillation.
The SMART Biphasic waveform utilized in the M4735A HeartStart XL
Defibrillator/Monitor has undergone clinical testing in adults. These trials
support the waveform’s effectiveness for defibrillation of ventricular
tachyarrhythmias at the 150J setting.
In Manual mode operation, the M4735A HeartStart XL Defibrillator/Monitor
incorporates some user selectable lower energy levels that were not used in
the clinical trials.
There are currently no clinical studies related to the use of the SMART
Biphasic waveform in pediatric applications.
Contraindications for Manual Defibrillation Therapy
Asynchronous defibrillation therapy is contraindicated in patients that exhibit
one or any combination of the following:
Defibrillating asystole can inhibit the recovery of natural pacemakers in the
heart and completely eliminate any chance of recovery. Asystole should not
be routinely shocked.
1-6Introduction
Noninvasive Pacing Therapy (Optional)
Noninvasive Pacing Therapy (Optional)
The M4735A HeartStart XL Defibrillator/Monitor provides noninvasive transcutaneous pacing by delivering a monophasic, electrical stimulus to the
heart. This stimulus is intended to cause cardiac depolarization and myocar
dial contraction. The medical care provider selects the stimulus current and
rate settings. The energy is delivered through multifunction defib electrode
pads applied to the patient’s bare chest.
Indications
Noninvasive pacing is one method of treating patients with symptomatic
bradycardia. It can also be helpful in patients with asystole, if performed
early.
Contraindications
Noninvasive pacing is contraindicated in the treatment of ventricular fibrillation. Noninvasive pacing in the presence of severe hypothermia may be contraindicated.
-
1
SpO2 Monitoring (Optional)
A pulse oximeter is a noninvasive device that indicates the oxygen saturation
(SpO
) of arterial blood. This measurement is obtained through a probe that
2
directs red and near infrared light through arterial beds. Hemoglobin absorbs
these lights differently when it is bound with oxygen. Pulse oximetry mea
sures this difference and translates the measurement into a saturation percentage that is displayed as an SpO2 reading.
M4735A HeartStart XL Defibrillator/Monitor1-7
-
Safety Considerations
Indications
SpO2 monitoring is indicated for use when it is beneficial to assess a patient’s
oxygen saturation level.
Contraindications
There are no known contraindications for SpO2.
NOTEReadings should be carefully considered in the presence of certain circum-
stances. Inaccuracies may result from the use of pulse oximeters in the presence of certain circumstances, such as hemoglobin saturated with compounds
other than oxygen, (such as carbon monoxide), hypothermia, hypovolemia,
patient movement, nail polish and excessive ambient light.
Safety Considerations
General warnings and cautions that apply to use of the M4735A HeartStart
XL Defibrillator/Monitor are provided in Chapter
and cautions specific to a particular feature are provided in the appropriate
section of this guide.
13. Additional warnings
1-8Introduction
Documentation and Training
Documentation and Training
Documentation for the M4735A HeartStart XL Defibrillator/Monitor
includes:
zM4735A HeartStart XL Defibrillator/Monitor Instructions for Use
zM4735A HeartStart XL Defibrillator/Monitor Quick Reference Card,
and
zAbout Sealed Lead Acid Batteries, an application note on battery
maintenance.
Training tools available for use with the M4735A HeartStart XL include:
zUsing the M4735A HeartStart XL Defibrillator/Monitor, a workbook
zHeartStart XL User Training CD-ROM
zHeartStart XL User Training Video
For additional online documentation and training, please visit our website:
1
www.medical.philips.com/cms.
Available online training materials include:
zAED Application Note
zSpO
zPacing Application Note
M4735A HeartStart XL Defibrillator/Monitor1-9
Concept Guide
2
2Getting Started
Congratulations on purchasing your HeartStart XL!
This chapter will give you a quick tour of your new defibrillator/monitor’s
controls and display.
The HeartStart XL ships complete with the cables, battery, and paper necessary for easy operation. This chapter will help you get your HeartStart XL up
and running by following a few easy steps, including:
zConnecting to AC Power
zInserting the battery
zIf desired, inserting the optional HeartStart XL-compatible Data Card
(see Chapter 11 for a listing).
NOTETo connect cables to the HeartStart XL, refer to “Setting Up and Configuring
the HeartStart XL” in Chapter 10.
2
M4735A HeartStart XL Defibrillator/Monitor2-1
Getting Acquainted
Energy Select Knob
Getting Acquainted
This section provides an overview of the HeartStart XL controls, connections,
and display layout. A review of control functionality is also provided.
Basic Orientation
Review the figure for a general layout of the controls, where the patient cables
connect, and where to insert the battery and Data Card.
Figure 2-1 Basic Orientation (Front)
Mark
AC Power
Batt Charge
Print Strip
Event
Summary
1
Vol ume
ECG Size
Pacer
Speaker
Patient Cable Connector
Data Card
Rate
Mode
Start/Stop
Output
Battery
2-2Getting Started
Figure 2-2 HeartStart XL (Back)
Getting Acquainted
Printer
NOTEIf your HeartStart XL does not have the SpO
these controls and the related information described in this section.
ECG Connector
SpO
Connector
2
ECG Out (Sync)
Jack
AC Power
or Pacing option, disregard
2
2
M4735A HeartStart XL Defibrillator/Monitor2-3
Getting Acquainted
Defibrillation Controls
Defibrillation controls consist of an energy select knob and a set of softkeys
that perform the function displayed as a label above each button. These
controls assist in both AED and Manual Mode defibrillation.
Audiovisual Controls
Adjusts the volume of voice prompts and the QRS beeper. At
the lowest setting, the QRS beeper is muted. The voice
prompts and other alert tones cannot be muted.
Adjusts the size of the ECG waveform displayed, printed, and
stored. Pressing
and simultaneously generates a
1 mV calibration pulse.
NOTETo permanently turn the QRS beeper off, use the General settings in
Configuration mode. See Chapter 10 “Setting Up and Configuring the HeartStart XL”.
Monitoring Controls
Monitoring controls consist of a set of softkeys that perform monitoring
functionality. These functions are displayed in the softkey label below each
button. Monitoring softkeys also control heart rate and SpO
alarms, and
2
selection of the ECG source to monitor.
2-4Getting Started
Getting Acquainted
Print Controls
Print controls perform the function shown on each button. The print
controls from are:
Strip
Prints ECG data, defibrillation events, and marked events
real-time or with a 6 second delay (as configured). Press to
start printing; press again to stop printing.
Summary
Mark
Prints the Event Summary. (See “Storing, Retrieving & Printing”for more information.) Printing may be stopped by pressing
Summary
the or button.
Strip
Inserts a time-stamped annotation in the Event Summary. May
be configured to print an annotated ECG strip when pressed.
Manual Mode Controls
Manual Mode controls provide access to manual defibrillation, and
synchronized cardioversion and optional pacing functionality.
Figure 2-3 Manual Mode Controls: Energy Select Knob and Pacing Controls
2
M4735A HeartStart XL Defibrillator/Monitor2-5
Getting Acquainted
Display Buttons
Can enable both Manual Mode and AED Mode. The AED
On position activates AED Mode. Manual On enables
Manual Mode, synchronized cardioversion and pacing
(optional).
Button below the display (far left) that enables
synchronized cardioversion when first pressed in Manual
Mode; disables synchronized cardioversion when pressed
again.
Pacer
green LED), allowing you to use the buttons below to
define pacing rate, mode, and current output. Also turns off
the Pacer function when pressed a second time.
Activates the pacing function buttons (as indicated by the
Rate
Start
Stop
Adjusts the pacing rate.
Starts pacing. Delivers pacer pulses when
first pressed; stops pacing when pressed
again.
Mode
Output
NOTESynchronized cardioversion and pacing controls only function when Manual
Selects Demand or Fixed Mode for pacing.
Adjusts the current output for pacing.
Mode is enabled.
2-6Getting Started
Display Layout
The following figures show the layout of the display in:
Getting Acquainted
zAED Mode, with ECG and SpO
zAED Mode, with ECG and SpO
zManual Mode
NOTEECG and SpO
disabled independently in the configuration.
Figure 2-4 AED Mode Display Layout (ECG and SpO2 Enabled)
Heart Rate
HR Alarm
ECG
Defibrillation
Soft Keys
monitoring capabilities enabled
2
monitoring capabilities disabled
2
monitoring capabilities for AED Mode may be enabled and
2
Lead
HR ALARM
132
System Message
Momentary Message
LEAD
SELECT
Lead II
User Message
PAUSE
Displayed
ON/OFF
ANALYZESHOCK
SpO2
SpO
value
2
SpO2
ALARM
86
Pulse 130
114J
Shocks: 0
00:15:02
SpO
alarm
2
Pleth Bar
Pulse Rate
ECG Gain
Current Charge
Shocks Delivered
Incident Timer
2
The Incident Timer shows the elapsed time since the HeartStart XL was
turned on, provided patient contact was established. If the HeartStart XL is
powered on after being off for less than two minutes, the Incident Timer
resumes where it left off. If power is off for more than two minutes, the Inci
dent Timer resets to zero (00:00:00). If an Event Summary is printed, the incident timer will be set to zero the next time the unit is turned on.
M4735A HeartStart XL Defibrillator/Monitor2-7
Getting Acquainted
Figure 2-5 AED Mode Display Layout (ECG and SpO2 disabled)
System Message
Momentary Message
ECG
Defibrillation
Soft Keys
PAU SE
User Message
ANALYZE
150J
Shocks: 0
00:15:02
SHOCK
ECG Gain
Current Charge
Shocks Delivered
Incident Timer
User messages accompany voice prompts to guide you through the defibrillation process.
System and Momentary Messages:
zalert you to conditions that require your attention,
zprovide status information, or
zoffer recommendations.
A System Message remains on the display until the condition that generated
the message no longer exists. A Momentary Message is temporary and
appears on the display for a minimum of 3 seconds. For a list of system and
momentary messages, see Chapter
12.
2-8Getting Started
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