Activeforever OnSite Defibrillator User Manual

For the ordinary person in the extraordinary moment
Philips HeartStart OnSite Defibrillator
Product information
Updated for Guidelines 2005
Sudden cardiac anyone, anytime,
Philips HeartStart OnSite Defibrillator
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•The current U.S. survival rate for SCA is less than 5%.
•The likelihood of successful resuscitation decreases by
about 10% with every minute that passes.
•An additional 40,000 lives could be saved each year in
the U.S. alone with widespread access to defibrillators.
arrest can happen to anywhere.
Power to save a life
Each year sudden cardiac arrest (SCA)
strikes approximately 340,000 people in the
U.S. alone, and hundreds of thousands more
worldwide.The majority of these people
have no warning, since they show no prior
symptoms. And sadly, fewer than 5% survive,
often because emergency medical services
cannot reach them in time.
SCA most often occurs when the electrical
system of the heart becomes chaotic,
causing it to stop beating effectively. Lacking
proper blood flow, the person becomes
unresponsive, stops breathing, and will die
unless promptly treated. CPR is important,
but it alone cannot restore a normal heart
rhythm. A “shock” from a defibrillator is the
most effective way to restore the heart’s
normal pumping rhythm. The victim’s best
chance of survival is to receive that shock
within 5 minutes of collapse. Just as seat belts
or airbags do not save every life in a traffic
accident, a defibrillator will not save every
person who suffers a sudden cardiac arrest.
Yet many lives could be saved if more people
could be reached more quickly.
Philips HeartStart Defibrillators enable
virtually anyone to treat the most common
cause of SCA by delivering a shock quickly
and effectively, wherever it happens – at
work, at play, in the air – providing the power
to save a life.
Philips HeartStart OnSite Defibrillator
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The Philips HeartStart
OnSite Defibrillator
Philips HeartStart OnSite Defibrillator
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Philips, the leader in portable defibrillation technology,
designed the HeartStart OnSite Defibrillator for the
ordinary person in the extraordinary moment.The first
commercial defibrillator available without a prescription,
the OnSite is designed to be the easiest to use and
most reliable defibrillator available.
technology, based on extensive research and user
feedback, has produced a defibrillator so easy to use that
you can potentially save the life of a coworker, friend, or
anyone else stricken with sudden cardiac arrest.
1,2
Our innovative
Weighing just 3.3 lbs., this small and lightweight
defibrillator can be easily carried to the victim’s side.
Using clear, calm voice instructions, the OnSite
Defibrillator guides you through each step of
defibrillation, including CPR Coaching. Integrated
SMART Pads placed on the victim’s bare skin transmit
information to the defibrillator, which senses and
adapts to your actions every step of the way.
HeartStart OnSite includes proven Philips technologies
for heart rhythm assessment (SMART Analysis) and
defibrillation energy delivery (SMART Biphasic). And
like all HeartStart Defibrillators, it can be used to treat
infants and children as well as adults.
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The first defibrillator available without a prescription to commercial users
Ready when needed
The OnSite has a long-life battery:
• 5-year shelf life plus 4-year installed life.
• The same battery technology used with confidence in millions
of cameras.
Automatic self-tests help ensure continued readiness:
• Daily self-tests check electrical components, subsystems and
battery.
• A self-test also verifies that the pads cartridge is installed and
in working order.
• A blinking green “Ready” light means the OnSite has passed its
last self-test, so you can be confident the defibrillator is ready
for use.
Easy to use
Using the HeartStart OnSite Defibrillator is simple. Pulling the
green handle activates the defibrillator and voice instructions.
These instructions are paced to your actions, to help guide you
through the entire process – from placing each pad on the
patient to delivering a defibrillation shock.
HeartStart OnSite determines if a heart rhythm
is shockable.
• If a shock is indicated, the defibrillator directs you to
press the flashing orange Shock button.Then HeartStart
OnSite delivers a dose of low-energy biphasic therapy, a
highly-effective defibrillation waveform that is also
gentle to the heart.
• If a shock is not indicated, the OnSite Defibrillator
instructs you to perform CPR.While performing CPR,
the defibrillator’s voice instructions can be activated to
coach you on the frequency and depth of compressions
as well as breaths. HeartStart OnSite also reminds you
to call emergency medical services (EMS). And should
EMS need a summary of care, it can be retrieved from
the defibrillator’s internal memory. An EMS provider
simply presses the i-button and HeartStart OnSite
verbally recounts events from its last clinical use.
Philips HeartStart OnSite Defibrillator
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Replaceable SMART Pads Cartridges
The cartridge contains two adhesive pads that are placed
on the patient’s bare skin as indicated by the pictures on
the pads.The pads are “smart” because they sense when
they have been removed from the cartridge and when
each has been applied to the patient, adjusting the voice
instructions to your actions.
Designed to help save a life in extraordinary circumstances
Lightweight
Just 3.3 pounds fully equipped.
Intuitive
Clean design and clear voice instructions, including CPR
Coaching, instill the confidence that’s needed when
treating a person in cardiac arrest.
Effective
Patented SMART Analysis heart rhythm assessment
and SMART Biphasic defibrillation therapy, clinically
proven in nearly 10 years of use. No other external
defibrillation therapy has been supported by more
published clinical data.
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The HeartStart OnSite can be used on patients of any
age, including infants and children. OnSite senses when
the special infant/child SMART Pads Cartridge is installed.
It automatically adjusts to use a lower energy level more
appropriate for infants and children, and also provides
coaching for performing infant/child CPR.
To practice your skills, a special training pads cartridge
(adult or infant/child) can be installed in the defibrillator.
It suspends the defibrillator’s ability to shock, while
walking you through patient care scenarios.
And with patented Quick Shock, the OnSite is fastest in
class at delivering a shock after CPR. Studies show that
minimizing time to shock after CPR may improve
4,5,6,7,8
survival.
2005 notes,“Reduction in the interval from compression
to shock delivery by even a few seconds can increase the
probability of shock success.”
As American Heart Association Guidelines
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Philips HeartStart OnSite Defibrillator
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Philips HeartStart OnSite Defibrillator
Product specifications
Defibrillator
Defibrillator Model HeartStart M5066A
Defibrillator Family HS1
How Supplied Defibrillator, Owner’s Manual, battery,1 adult
SMART Pads cartridge, Quick Reference Guide and Quick Start poster
Waveform Truncated Exponential Biphasic.Waveform parameters
adjusted as a function of each patient’s impedance.
Energy Single energy output. Adult: nominal 150 Joules into a
50 ohm load.Infant/Child:nominal 50 Joules into a 50 ohm load. Automatically set based on type of SMART Pads cartridge installed.
Shock-to-Shock Typically less than 20 seconds between shocks in a series. Cycle Time
Quick Shock Able to deliver a shock after the end of a CPR interval,
typically in eight seconds.
Voice Instructions Detailed voice messages guide responder through use
of the defibrillator.
CPR Coaching Instructions for adult and infant/child CPR available at
user’s option.
Shock Delivery Via adhesive pads placed on patient’s bare skin as
illustrated on pads.
Controls Green SMART Pads cartridge handle, green On/Off
button,blue i-button,orange Shock button
Indicators Ready light;blue i-button;caution light
Physical Specifications
Size 2.8 x 7.4 x 8.3 inches (7 x 19 x 21 cm) H x D x W
Weight With battery and pads case: 3.3 lbs.(1.5 kg)
Without battery or pads case: 2.4 lbs.(1 kg)
Environmental/Physical Requirements
Sealing Solid objects per EN60529 class IP2X
Drip-proof per EN60529 class IPX1
Temperature Operating:32º - 122º F (0º- 50º C)
Standby:50º - 109º F (10º- 43º C)
Humidity Operating:0% to 95% relative, non-condensing
Standby:0% to 75% relative,non-condensing
Altitude Operating:0 to 15,000 feet
Standby:0 to 8,500 feet > 48 hours and 8,500 to 15,000 feet < 48 hours
Shock/Drop Abuse Withstands 1 meter drop to any edge,corner or surface.
Vibration Meets EN1789 random and swept sine,road ambulance
specification in operating and standby states.
EMI (Radiated/Immunity) Meets EN55011 Group 1 Level B Class B and
EN61000-4-3.
Patient Analysis System
Patient Analysis Evaluates patient ECG to determine if a rhythm is
shockable. Rhythms considered shockable are ventricular fibrillation (VF) and certain ventricular tachycardias (VT) associated with lack of circulation. For safety reasons,some VT rhythms associated with circulation will not be interpreted as shockable,and some very low-amplitude or low-frequency rhythms will not be interpreted as shockable VF.
Sensitivity/Specificity Meets AAMI DF80 guidelines and AHA
recommendations for adult defibrillation (Circulation 1997;95:1677-1682).
Artifact Detection The effects of pacemaker artifact and electrical noise
are minimized with artifact detection.
Battery (M5070A)
Type 9 Volt DC,4.2 Ah,composed of disposable long-life
Capacity Minimum 200 shocks or 4 hours of operating time
Install-by Date Battery is labeled with an install-by date of at least five
Standby Life Four years typical when battery is installed by the
lithium manganese dioxide primary cells.
(EN 60601-2-4:2003)
years from date of manufacture.
install-by date.(Will power the AED in standby state within the specified standby temperature range, assuming one battery insertion test and no defibrillation uses.)
SMART Pads
Adult SMART M5071A defibrillation pads for patients 8 years of age Pads Cartridge and older or 55 lbs.(25 kg) and over.
Infant/Child SMART M5072A defibrillation pads for patients under 8 years Pads Cartridge of age or 55 lbs.(25 kg).Rx only.
Energy Delivered Adult:nominal 150 Joules into a 50 ohm load
How Supplied Disposable cartridge, containing adhesive
Active Surface Area 13.2 in
Cable Length Adult pads:54 in (137.1 cm)
Use-by Date Cartridge is labeled with a use-by date of at least two
Infant/Child:nominal 50 Joules into a 50 ohm load
defibrillation pads,clicks into defibrillator for an integrated pads solution.
2
(85 cm2) each
Infant/Child pads:40 in (101.6 cm)
years from date of manufacture.
Training Pads
Adult Training Pads M5073A Cartridge
Infant/Child Training M5074A Pads Cartridge
Function Special pads put HeartStart OnSite into training mode
and disable its energy delivery capability.Training pads feature 8 real-world training scripts.Used with training mat (included) or with adapters on manikins.
Automated and User-activated Self-tests
Daily Automatic Self-tests Tests internal circuitry,waveform delivery system, pads
Pads Integrity Test Specifically tests readiness-for-use of pads
Battery Insertion Test Upon battery insertion, extensive automatic self-tests
Status Indicator Blinking green “Ready” light indicates ready for use.
cartridge and battery capacity.
(gel moisture).
and user-interactive test check device readiness.
Audible “chirp” indicates need for maintenance.
Data Recording and Transmission
Infrared Wireless transmission of event data to a PC or Palm
Data Stored First 15 minutes of ECG and the entire incident’s events
* Refer to the HeartStart OnSite Defibrillator Owner’s Manual for detailed product instructions.
All specifications based on 25º C unless otherwise noted.The defibrillator and its accessories are made of latex-free materials.
PDA,using the IrDA protocol.
and analysis decisions.
®
Philips HeartStart OnSite Defibrillator
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Philips Medical Systems is part of
Royal Philips Electronics
Interested?
Would you like to know more about our innovative
products? Please do not hesitate to contact us.
We would be glad to hear from you.
On the web
www.philips.com/heartstart
Philips—The trusted choice
• A Fortune Global 500 company, Philips is one of the world’s largest medical
products companies with annual revenue of over $7 billion.
• With over 350,000 automated external defibrillators installed, Philips is the
leader in public access defibrillation.
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• Over 7 billion HeartStart Defibrillator service hours have been logged,
with an additional 7 million added every day.
• Over 17% of Fortune 1000 companies, 8 out of 10 major airlines, and
43 professional sports teams rely on Philips HeartStart Defibrillators.
The HeartStart OnSite Defibrillator is the first defibrillator available for
commercial and institutional users without a prescription.As the leader in
innovative defibrillation technology, Philips is committed to making defibrillators
more widely available so that more lives can be saved. Now with over-the-
counter status, Philips is making it easier for companies and organizations to
institute early defibrillation programs.
Via email
medical@philips.com
By fax
+31 40 27 64 887
By postal service
Philips Medical Systems
3000 Minuteman Road
Andover, MA 01810-1085
By phone
Asia
Tel: +852 2821 5888
Europe, Middle East, Africa
Tel: +49 7031 4632121
Latin America
Tel: +55 11 2125 0764
North America
Tel: +1 800 453 6860
Defibrillators are one part of a well-planned resuscitation program, which also
should include responder training in CPR and AED use. Philips recommends
medical oversight of your early defibrillation program by a physician or other
authorized medical practitioner. Consult your state and local requirements
regarding owning and operating defibrillators, and medical oversight.
HeartStart user considerations
• You cannot use the HeartStart OnSite to treat yourself.
• Responding to cardiac arrest may require you to kneel.
To learn more about the HeartStart OnSite Defibrillator and Philips Medical
Systems, visit www.philips.com/heartstart or call 1-800-453-6860.
References
1
Andre, et al.Automated External Defibrillator Use by Untrained Bystanders: Can the Public-use Model Work? Prehospital Emergency Care 2004;8:284-291.
2
Snyder,Time to Shock vs Voice Prompt Duration: Optimization of Defibrillators for Public Access and Home Deployment. 6th Scientific Congress of the European Resuscitation Council, Oct 2002.
3
The Infant/Child pads cartridge is sold separately,and available only under the order of a physician.
4
Yu et al.Adverse Outcomes of Interrupted Precordial Compression During Automated Defibrillation.Circulation 2002; 106:368-372.
5
Eftesol T,Sunde K, Steen PA.Effects of Interrupting Precordial Compressions in the Calculated Probability of Defibrillation Success During Out-of-Hospital Cardiac Arrest. Circulation 2002;105:2270-2273.
6
Snyder et al. Biphasic Defibrillation Waveform Combined with AED-Imposed “Hands-Off” Intervals Significantly Affect Outcome Following Prolonged Cardiac Arrest.Abstract from 7th Scientific Congress of the European Council, 2004.
7
Snyder & Morgan. CPR Interruption Interval Varies Widely Among Commercially Available AEDs. Abstract from 7th Scientific Congress of the European Council, 2004.
8
Snyder,D.E. and Morgan,C. Wide Variations in Cardiopulonary Resuscitation Intervals Among Commercially Available Automated External Defibrillators May Affect Survival Despite High Defibrillation Efficacy. Critical Care Medicine. 2004;32(9) Supplement:S421-S424.
9
Philips Medical Systems. SMART Biphasic Studies, listed alphabetically by study author.
10
American Heart Association.2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2005.112:IV-36.
11
Frost & Sullivan, 2005.
© 2007 Koninklijke Philips Electronics N.V. All rights are reserved.
Philips Medical Systems Nederland B.V. reserves the right to make changes in specifications and/or to discontinue any product at any time without notice or obligation and will not be liable for any consequences resulting from the use of this publication.
Printed in the Netherlands 4522 962 16731 * JAN 2007
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