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P O W E R TO SAV E A L I F E
D E F I B R I L L AT O R S
HEARTSTART
AUTOMATED EXTERNAL DEFIBRILLATORS
TECHNICAL REFERENCE MANUAL
Edition 3
Introductory Note
In 1992, Heartstream, Inc. was founded with the mission to develop a small, low-cost,
rugged, reliable, safe, easy-to-use, and maintenance-free automated external defibrillator
(AED) that could be successfully used by a layperson responding to sudden cardiac arrest.
Heartstream introduced its first AED, the ForeRunner, in 1996. The Heartstream ForeRunner
AED marked the first widespread commercial use of a biphasic waveform in an external
defibrillator.
Hewlett-Packard (HP) purchased Heartstream in 1997. Heartstream then added a relabeled
version of the ForeRunner for Laerdal Medical Corporation called the Heartstart FR.
In 1999, Hewlett-Packard spun off the Medical Products Group, including the Heartstream
Operation, into Agilent Technologies. While part of Agilent, Heartstream introduced a new
AED, the Agilent Heartstream FR2. Laerdal Medical marketed this device as the Laerdal
Heartstart FR2.
Heartstream became part of Philips Medical Systems in 2001 when Philips purchased the
entire Medical Group from Agilent Technologies. In 2002, Philips re-branded all of their
defibrillators as HeartStart Defibrillators. In the same year, Philips introduced a new family of
defibrillators, including the HeartStart Home and HeartStart OnSite AEDs.
This manual is intended to provide technical and product information that generally applies to
the following AEDs:
ForeRunner and FR AEDs:
Heartstream ForeRunner Laerdal Heartstart FR
FR2 series AEDs:
Agilent Technologies FR2 Laerdal Heartstart FR2
Philips HeartStart FR2+ Laerdal Heartstart FR2+
HS1 family of AEDs:
Philips HeartStart OnSite Laerdal HeartStart
Philips HeartStart Home Philips M edic al Sys tems
To help simplify the information presented, the HeartStart FR2 is used as an example in many
parts of this manual. Where the discussion involves features related to a specific product, it is
so noted.
CONTENTS
1 HeartStart Automated External Defibrillators
Design Philosophy for HeartStart AEDs .............................. 1-1
Design Features of HeartStart AEDs .................................... 1-2
Reliability and Safety ...................................................... 1-2
Ease of Use ...................................................................... 1-3
No Maintenance .............................................................. 1-4
2 Defibrillation and Electricity
The Heart's Electrical System ................................................. 2-1
Simplifying Electricity ................................................................ 2-4
3 SMART Biphasic Waveform
A Brief History of Defibrillation ............................................... 3-1
SMART Biphasic ........................................................................ 3-4
Understanding Fixed Energy ........................................ 3-5
Evidence-Based Support for the SMART
Biphasic Waveform ........................................................ 3-6
SMART Biphasic Superior to Monophasic ............... 3-7
Key Studies ...................................................................... 3-8
Frequently Asked Questions ................................................... 3-9
Are all biphasic waveforms alike? ............................... 3-9
How can the SMART Biphasic waveform be more
effective at lower energy? ............................................. 3-9
Is escalating energy required? ..................................... 3-11
Is there a relationship between waveform, energy
level, and post-shock dysfunction? ............................. 3-13
How does SMART Biphasic compare to other
biphasic waveforms? ..................................................... 3-15
Is there a standard for biphasic energy levels? ....... 3-15
Commitment to SMART Biphasic ............................... 3-16
Philips M edic al Sys tems
4 SMART Analysis
Pad Contact Quality .................................................................. 4-1
Artifact Detection ....................................................................... 4-1
Arrhythmia Detection ................................................................ 4-4
Shockable Rhythms .................................................................. 4-6
Validation of Algorithm .............................................................. 4-9
ECG Analysis Performance .......................................... 4-9
i
ii
5 Self-Tests
Battery Insertion Test ................................................................ 5-1
ForeRunner and FR2 Series AEDs ............................. 5-2
HeartStart HS1 Family of AEDs .................................. 5-2
Periodic Self-Tests .................................................................... 5-3
"Power On" and "In Use" Self-Tests .......................... 5-5
Cumulative Device Record ........................................... 5-6
Supplemental Maintenance Information for
Technical Professionals ............................................................ 5-7
Background ...................................................................... 5-7
Calibration requirements and intervals ....................... 5-7
Maintenance testing ....................................................... 5-7
Verification of energy discharge .................................. 5-7
Service/Maintenance and Repair Manual .................. 5-7
6 Theory of Operation
Overview ...................................................................................... 6-1
User interface ............................................................................. 6-3
Operation .......................................................................... 6-3
Maintenance ..................................................................... 6-3
Troubleshooting ............................................................... 6-3
Configuration ................................................................... 6-4
Control Board ............................................................................. 6-4
Battery .......................................................................................... 6-4
Power Supply ............................................................................. 6-4
ECG Front End ........................................................................... 6-5
Patient Circuit ............................................................................. 6-5
Recording .................................................................................... 6-5
Temperature Sensor ................................................................. 6-6
Real-Time Clock ......................................................................... 6-6
Philips Medical System s
IR Port ........................................................................................... 6-6
TECHNICAL REFERENCE GUIDE
iii
7 Literature Summary for HeartStart
AEDs
References .................................................................................. 7-1
Animal Studies (peer-reviewed manuscripts) ........... 7-1
Electrophysiology Laboratory and other studies
(peer-reviewed manuscripts) ........................................ 7-2
Sudden Cardiac Arrest
(peer-reviewed manuscripts) ........................................ 7-3
Animal Studies (abstracts) ............................................ 7-4
Out-of-Hospital Study (abstract) ................................. 7-4
Related Papers and Publications ................................ 7-4
Study Summaries ....................................................................... 7-6
HeartStart Defibrillation Therapy Testing in Adult
Victims of Out-of-Hospital Cardiac Arrest ................ 7-6
HeartStart Patient Analysis System Testing with
Pediatric Rhythms ........................................................... 7-8
HeartStart Defibrillation Therapy Testing in a Pediatric
Animal Model ................................................................... 7-10
8 Condensed Application Notes
Defibrillation on Wet or Metal Surfaces ............................... 8-2
Defibrillating in the Presence of Oxygen .............................. 8-2
Value of an ECG Display on HeartStart AEDs ................... 8-3
Defibrillation Pad Placement with HeartStart
AEDs ............................................................................................. 8-4
SMART Analysis - Classification of Rhythms ...................... 8-5
Artifact Detection in HeartStart AEDs .................................. 8-6
Use of Automated External Defibrillators (AEDs)
in Hospitals .................................................................................. 8-7
Manual Mode of Operation with HeartStart
AEDs .................................................................................. 8-7
Analysis System in HeartStart AEDs .......................... 8-8
Philips Medical System s
Shockable/Non-Shockable Rhythms .......................... 8-9
Defibrillation Electrode Pads for HeartStart
AEDs .................................................................................. 8-10
CPR Performed at High Rates of Compression ...... 8-10
HeartStart AED Battery Safety ............................................... 8-11
Differences in Battery Chemistries Utilized by
Automated External Defibrillators ................................ 8-11
Additional Advantages of the HeartStart AEDs
Battery: Disposable vs. Rechargeable ....................... 8-12
Contents
iv
9 Technical Specifications
Standards Applied ..................................................................... 9-1
AED Specifications ................................................................... 9-2
Physical ............................................................................. 9-2
Environmental ................................................................... 9-3
AED (HeartStart HS1 Family) ...................................... 9-4
ECG Analysis System .................................................... 9-5
Display ............................................................................... 9-6
Controls and Indicators ................................................. 9-7
Data Management Specifications ............................... 9-8
Accessories Specifications ..................................................... 9-9
Battery Packs ................................................................... 9-9
HeartStart Defibrillation Pads ...................................... 9-9
10 Features of the ForeRunner, FR2,
and HS1 AEDs
Overview ...................................................................................... 10-1
Feature Comparison .................................................................. 10-2
Voice Prompt Comparison ...................................................... 10-3
Additional HS1 Voice Instructions .............................. 10-5
AED Trainers ............................................................................... 10-6
Training Scenarios .......................................................... 10-7
Pediatric Pads ............................................................................ 10-8
11 HeartStart Data Management Software
Comparison of Event Review Pro 2.3 and
Event Review 3.0 ....................................................................... 11-2
System Requirements ............................................................... 11-3
Operating Systems ......................................................... 11-3
Data Card Readers ......................................................... 11-4
Previous Data Management Software Versions ................. 11-5
System Annotations .................................................................. 11-6 Philips Medical System s
Technical Support for Data Management Software .......... 11-8
Online ................................................................................ 11-8
Via Telephone .................................................................. 11-8
Appendix
Troubleshooting the HeartStart the ForeRunner and
FR2 Series AEDs ....................................................................... A-1
TECHNICAL REFERENCE GUIDE
1
1 HeartStart Automated External
Defibrillators
Each year in the United States alone, approximately 250,000 people suffer
sudden cardiac arrest (SCA). Fewer than 5% of them survive. SCA is most
often caused by an irregular heart rhythm called ventricular fibrillation (VF), for
which the only effective treatment is defibrillation, an electrical shock. Often, a
victim of SCA does not survive because of the time it takes to deliver the
defibrillation shock; for every minute of VF, the chances of survival decrease
by about 10%.
Traditionally, only trained medical personnel were allowed to use a defibrillator
because of the high level of knowledge and training involved. Initially, this
meant that the victim of SCA would have to be transported to a medical
facility in order to be defibrillated. In 1969, paramedic programs were
developed in several communities in the U.S. to act as an extension of the
hospital emergency room. Paramedics went through extensive training to
learn how to deliver emergency medical care outside the hospital, including
training in defibrillation. In the early 1980s, some Emergency Medical
Technicians (EMTs) were also being trained to use defibrillators to treat
victims of SCA. However, even with these advances, in 1990 fewer than half
of the ambulances in the United States carried a defibrillator, so the chances
of surviving SCA outside the hospital or in communities without highly
developed Emergency Medical Systems were still very small.
The development of the automated external defibrillator (AED) made it
possible for a defibrillator to be used by the first people (typically lay persons)
responding to an emergency. People trained to perform CPR can now use a
defibrillator to defibrillate a victim of SCA. The result: victims of sudden
cardiac arrest can be defibrillated more rapidly than ever before, and they
have a better chance of surviving until more highly trained medical personnel
arrive who can treat the underlying causes.
Philips M edical S ys tems
Design Philosophy for HeartStart AEDs
The HeartStart AEDs are designed specifically to be used by the first people
responding to an emergency. It is reliable, easy to use, and virtually
maintenance free. The design allows HeartStart AEDs to be used by people
with no medical training in places where defibrillators have not traditionally
been used. In order to accomplish this, consideration was given to the fact
that an AED might not be used very often, may be subjected to harsh
environments, and probably would not have personnel available to perform
regular maintenance.
1-1
1-2
The HeartStart AED was not designed to replace the manual defibrillators
used by more highly trained individuals. Instead, it was intended to
complement the efforts of medical personnel by allowing the initial shock to
be delivered by the first person to arrive at the scene. Some models of
HeartStart AEDs can be configured for advanced mode use, to allow the
device to be used as a manual defibrillator. This can be beneficial for
transitioning the patient care from a lay rescuer to more highly trained medical
personnel.
Design Features of HeartStart AEDs
Reliability and Safety