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School Health-Product Education- Lifepak 500 Automated External Defibrillator
 
Lifepak 500 Automated External Defibrillator

Introduction
Product Overview and Description
Product Use and Procedure
Features and Benefits
Frequently Asked Questions
Technical Specifications
Articles / Sales Brochures / Manuals
Warranty
Legislation
Customer Testimonials
Other Information
Product Ordering Information
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Introduction

The Lifepak 500 Automated External Defibrillator was designed to be used by first responders in cardiac emergencies. Lifepak's durable and lightweight design (only 7lbs) makes it extremely portable. Low maintenance requirements and intuitive operation make it the ideal product for infrequent AED users.




Product Overview and Description
The LIFEPAK 500 is designed for an expanded range of first responders, breaking new ground in simplicity of use, low maintenance, and low cost. This unit puts response capability in more hands-not only medical technicians and firefighters, but also others such as police officers, security guards, etc. Virtually anyone can be trained to respond to a cardiac arrest with a LIFEPAK 500 AED.

The technology supporting the LIFEPAK 500 has been refined over more than a decade of AED development and manufacturing. A field-proven algorithm provides ECG analysis to determine whether a defibrillation shock is advised. Our QUIK-COMBO™ electrodes can be preconnected to save time on-scene. And you have your choice of a five-year; maintenance free, 300 shocks, non-rechargeable lithium battery, or a rechargeable sealed lead acid battery.

Carefully chosen biphasic waveforms hold promise for improving emergency cardiac care when they are implemented at appropriate energy levels. Biphasic technology offers the option of escalating energy increments up to 360J-the industry-standard. The LIFEPAK 500 AED also measures the patient's impedance and tailors the delivery of the energy to the patient's needs. The result is a therapy that optimizes shock success.

The LIFEPAK 500 offers the option of rechargeable sealed lead acid or non-rechargeable lithium batteries. Lithium batteries have up to a 5-year or 300+ shock useful life, requiring no maintenance. Customers with higher equipment usage rates have the option of a rechargeable battery.

The LIFEPAK 500 has extensive device auto-testing: power on, daily, weekly and monthly self tests for ease of device maintenance. A device status indicator is located on the handle of the device.

The LIFEPAK 500 AED may be customizable, allowing for flexible medical protocols. The LIFEPAK 500 can be ordered and shipped with either the factory default settings or any of the alternate settings. In addition, these settings can be changed in setup mode after receipt of device.

 



Product Use and Procedure
The LIFEPAK 500 provides multiple visual and audible prompts, which makes it easy to use in emergencies, dark areas and in noisy environments. This includes audible voice prompts plus two visual indicators, the LED screen and flashing lights lead the user to the correct therapy button.

The LIFEPAK 500 screen provides important information such as the number of shocks and user programmable CPR count down for emergency response personnel.

The Medtronic Physio-Control LIFEPAK 500 provides patented motion detection that recognizes patient movement caused by the provider. This artifact can cause a non-shockable rhythm to appear shockable (asystole to look like v-fib) and vice versa (v-fib to appear as NSR recommending no shock). Motion alerts prompts the rescuer to not touch the patient allowing EKG analysis to proceed.

The American Heart Association's guidelines recommend escalating energy levels of 200, 300 and 360 Joules. The LIFEPAK 500 meets these guidelines.

The LIFEPAK 500 is IPX4 certified in Water Resistance. IPX4 testing is spraying the unit at all angles on all surfaces. This is the highest certification of water resistance in AED's today. Many units are IPX3, which means they were tested by spraying at 60-degree angles on the vertical surfaces only.

The LIFEPAK 500 has a visible indicator on the handle of the unit that displays an OK sign letting the user know the unit is rescue ready. It also contains a battery display that illuminates when the battery is low. Once this occurs the unit still provides a minimum of eleven shocks with the lithium battery. An audible alarm will beep three times very twenty minutes to notify the user. The non-rechargeable lithium LiSO2 battery has a five-year shelf life. (Full operational life after five years of non-use). As with all batteries, regardless of manufacturer, actual life varies due to environmental factors and usage patterns.

Lifesaving devices such as the LIFEPAK 500 should be inspected on a regular basis.
 

 

   



Features and Benefits
Features of the LIFEPAK 500
Simple two button operation
5 year non-rechargeable lithium battery
Shockproof carrying case
Automated daily self testing
Pre-connected Quick-Combo patient electrodes
Concise voice prompting
On screen CPR time, shock count and real-time clock
Solid state memory for patient ECG data and optional voice recording
Modem and printer ready for local or remote downloading of patient data
Devise follows the American Heart Association Guidelines shocking at 200, 300, 360 joules.
Motion Detection feature deciphers the difference between chest compressions from heart beat.
5 year free on-site technical assistance.



Frequently Asked Questions
Obtained from the American Heart Association Website

General Questions
Q: What does AED stand for?
A: AED stands for automated external defibrillator (or automated external defibrillation).

Q: What is an AED?
A: An AED is a device used to administer an electric shock through the chest wall to the heart. Built in computers assess the patient's heart rhythm, judge whether defibrillation is needed, and then administer the shock. Audible and or visual prompts guide the user through the process.

Q: How does an AED work?
A: A microprocessor inside the defibrillator interprets (analyzes) the victim's heart rhythm through adhesive electrodes. The computer analyzes the heart rhythm and advises the operator whether a shock is needed. AEDs advise a shock only to ventricular fibrillation and fast ventricular tachycardia. The electric current is delivered through the victim's chest wall through adhesive electrode pads.

Q: Why are AED's important?
A: AED's are important because they strengthen the Chain of Survival. They can restore a normal heart rhythm in victims of sudden cardiac arrest. New, portable AEDs enable more people to respond to a medical emergency that requires defibrillation. When a person suffers a sudden cardiac arrest, their chances for survival decreases seven to ten percent for each minute that passes without defibrillation.

Q: Who can use an AED?
A: Most AED's are designed to be used by non-medical personnel who have been properly trained. Having more people in the community who can respond to a medical emergency by providing defibrillation will greatly increase sudden cardiac arrest survival rates.

Q: Why does someone having a heart attack need an AED?
A: When a heart attack becomes a full cardiac arrest, the heart most often goes into uncoordinated electrical activity called fibrillation. The heart twitches ineffectively and cannot pump blood. The AED delivers electric current to the heart muscle, momentarily stunning the heart, stopping all activity. This gives the heart an opportunity to resume beating effectively.

Q: Will an AED always resuscitate someone in cardiac arrest?
A: The AED treats only a heart in ventricular fibrillation (VF), an irregular heart rhythm. In cardiac arrest without VF, the heart does not respond to electric currents but needs medications. The victim needs breathing support. AEDs are less successful when the victim has been in cardiac arrest for more than a few minutes, especially if no CPR was provided.


AED USE
Q: Is an AED safe to use?
A: An AED is safe to use by anybody who has been trained to operate it. Studies have shown the devices to be 90% sensitive (able 90% of the time to detect a rhythm that should be defibrillated) and 99% specific (able 99% of the time to recommend not shocking when defibrillation is not indicated). Because of the wide variety of situations in which it will be typically used, the AED is designed with multiple safeguards and warnings before any energy is released. The AED is programmed to deliver a shock only when it has detected VF. However, potential dangers are associated with AED use. That is why training-including safety and maintenance is important.

Q: Are AED's safe to use on children?
A: An AED should not be used on a child younger than 8 years old or weighing less than 55 pounds.

Q: Will I get zapped if I shock a victim in the rain or near water?
A: It is remotely possible to get shocked or to shock bystanders if water is near or underneath the victim. Try to move the victim to a dry area and cut off wet clothing. Also be sure that the skin has been toweled dry so the electrode pads will stick to the skin. Sat the moment you press the SHOCK button, you must make sure that no one, including yourself (the AED operator), touches any part of the victim.

Q: Can an AED make mistakes?
A: An AED will almost never decide to shock an adult victim when the victim is in non-VF. AEDs "miss" fine VF only about 5% of the time. The internal computer uses complex analysis algorithms to determine whether to shock. If the operator has attached the AED to an adult victim who is not breathing and pulse less (in cardiac arrest), the AED will make the correct "shock" decision more than 95 out of 100 times and a correct "no shock indicated" decision more than 98 out of 100 times. This level of accuracy is greater than the accuracy of emergency professionals.

Q: Why do you stop CPR as the electrode pads are placed and analysis occurs?
A: For the AED to analyze accurately, the victim must be motionless. Sometimes there will be agonal respiration (a gasping breath that can occur when the heart is stopped) that causes movement. AEDs can recognize this extra motion and indicate, "motion detected" to the operator. This warns the operator to assess carefully for extra movements from the victim or other people at the scene.

Q: Why does it seem that the victim goes without CPR for so long during defibrillation, and why does an AED shock so many times?
A: After prescribed periods of CPR, the machine analyzes the victim's rhythm. The victim must remain motionless while the AED decides to shock and delivers the shock. Sometimes the victim does not change from VF to non-VF at once. These victims require multiple shocks. If repeated shocks are needed, the shocks are "stacked" in sets of three to increase their effectiveness.


AED Placement
Q: What is public access to defibrillation?
A: Public access to defibrillation (PAD) means making AEDs available in public and/or private places where large numbers of people gather or people who are at high risk for heart attacks live.

Q: Why should people who are responsible for operating an AED receive CPR training?
A: Early CPR is an integral part of providing lifesaving aid to people suffering cardiac arrest. The ventilation and compression skills learned in a CPR class help to circulate oxygen rich blood to the brain. After delivering a series of three electric shocks, the typical AED will prompt the operator to continue CPR while the device continues to analyze the victim.

Q: If AED's are so easy to use, why do people need formal training in how to use them?
A: An AED operator must know how to recognize the signs of sudden cardiac arrest, when to activate the EMS system, and how to do CPR. It is also important for operators to receive formal training on the AED model they will use so that they become familiar with the device and are able to successfully operate it in an emergency. Training also teaches the operator how to avoid potentially hazardous situations.

Q: Can anyone buy an AED?
A: AED's are manufactured and sold under the guidelines approved by the Food and Drug Administration. Current FDA rules require someone who purchases an AED to present a physician's prescription for the device.



Technical Specifications
Technical Specs of the LIFEPAK 500 - Defibrillator
Input: ECG via QUICK-COMBO or FAST-PATCH disposable Electrodes. Standard placement (anterior-lateral).
Electrical Protection: Input protected against high voltage defibrillator pulses per IEC 60601/EN60601.
Safety Classification: Internally powered equipment IEC60601-1/EN60601-1, 5.1.
Waveform: Monophasic pulse (Edmark) per AAMIDF2-1989, 3.2.1.5.1.
Biphasic truncated exponential, with voltage and duration compensation for patient impedance. *
Output Energy Sequence: Monophasic: 200, 200, 360 joules (360 joules thereafter) or 200, 300, 360 joules (360 joules thereafter).
Biphasic: Three levels, user configurable from 200 to 360 joules, delivered (Level 1, Level 2, Level 3, Level 3…).
Charge Time: With a new, non-rechargeable battery pak, or a new, fully charged rechargeable battery pak:
200 joules in less than 9 seconds
360 joules in less than 15 seconds
Controls:
ON/OFF Turns device power on and off
ANALYZE (optional) Starts ECG analysis
SHOCK Delivers defibrillation energy
Active only when Shock Advisory System advises defibrillation.
Clock Set: Two switches are provided to set the clock
Display: Two-line, 20 character per line dot matrix Liquid Crystal Display.
Low Battery Indicator:
Low battery icon:
At least 11 discharges remaining with non-rechargeable battery pak.
At least 6 discharges remaining with rechargeable battery pak.
Service Indicator: Service icon.
Displayed Message: Messages prompt user through complete voice operating sequence.
Audible Tones: Coded tones assist user through device operation and alert operator of display messages.
Voice Prompts: Prompt user through complete operation sequence.
*Note: Specifications apply from 25 to 200 ohms. Voltage compensation
Is limited to the voltage that would result in the delivery of 360 joules into 50 ohms.

 
Technical Specs of the LIFEPAK 500 - Environmental
Operating Temperature: 0 degrees to 50 degrees C
Storage Temperature: -30 degrees to +65 degrees C without battery and electrodes.
-30 degrees to +65 degrees C with batteries and electrodes, maximum exposure time limited to one week.
Atmospheric Pressure: 760 to 429 mmHg (0 to +15,000 ft above sea level).
Relative Humidity: 10 to 95% (non-condensing).
Water Resistance: IEC 60529/EN 60529 IPX4 "Splash-proof" with electrodes or connector cover installed.
Shock: MIL-STD-801E, Method 516.4, Procedure 1 (40g, 6-9ms pulse, ½ sine each axis).
Vibration: Monophasic version: MIL-STD-801E, Method 514.4, Category 10.
Biphasic Version: MIL-STD-810E, Method 514.4

Technical Specs of the LIFEPAK 500 - Batteries
Non-rechargeable Lithium Battery Pack
Type: Sealed lithium, 12V, 7.5 amp-hours
Certification: FAA: TSO-C97 or CAA: BS2G237
Capacity: Typical: 312 full discharge or 14 hours of "ON" time. Minimum: 230 full discharges with a new battery.
Shelf Life: 5 years (4 years for aircraft use.)
Weight: 0.5 KG (1.2 lbs).

Technical Specs of the LIFEPAK 500 - General
Physical Characteristics
Height: 4 inches
Width: 10.5 inches
Depth: 11.6 inches including handle
Weight: Monophasic 6.6 lbs (without battery or electrodes).
Biphasic 5.3 lbs (without battery or electrodes).
   

 

Articles / Sales Brochures / Manuals
Click here to read a press release from Oct. 20th, 2003, announcing a national school education initiative to inform parents, students, community leaders and educators about the importance of access within schools to automated external defibrillators (AEDs), which can save lives of those who experience sudden cardiac arrest (SCA).

Click here to review the AED story that aired on Good Morning America on September 4th, 2003

The following Medtronic brochures are available from School Health Corporation; please contact jdidier@healthgiant.com to order:
Product Number Brochure Name
99-284 Medtronic: Biphasic Defibrillation
99-189 Medtronic: LIFEPAK 500 Product Specs
99-185 Medtronic: LIFEPAK 500T Trainers Specs
99-293 Medtronic: Is Your Community Heart Safe
99-298 Medtronic: Making Your Schools Heart Safe.
99-052 Medtronic: You Can Save Lives
99-314 Medtronic: Wall Cabinets for LIFEPAK 500
99-311 Medtronic: Saving Lives on the Golf Course
99-434 Medtronic: Saving Live in Schools
99-438 Medtronic: Keep your Athletes in the Most Important Game

School News Clippings
Following are some "News Bytes" relating to AED's:

Glenbard South coach better after collapsing at pep rally --- Chicago Daily Herald --- November 8 2001 --- The assistant cross country coach who collapsed was lucky that Glenbard HS District 87 schools are AED equipped. "It was the AED that saved him. The people who purchased that, applied it and successfully used it, they all saved his life," commented Lisle-Woodridge Fire Dept's EMS coordinator, Keith Stegman.

High Schools; Banning Player Dies of Cardiac Arrest --- Los Angeles Times --- November 13 2001 --- CPR was administered to this 17-yr-old football player who collapsed during practice. Paramedics arrived about 5 minutes after 911 call was made. They administered defibrillation, and transported him to the hospital, where he arrived in full cardiac arrest. This player failed an initial health screening, but was later cleared to play after being examined by a cardiologist.Young athletes at a higher risk for heart-related death --- The Milwaukee Journal Sentinel --- November 12 2001 --- Researchers found young athletes are more than twice as likely to die suddenly from cardiac causes than those who are not athletes, in a study of 300 sudden deaths in athletes and non-athletes ages 12 to 35. Screening is urged, methods are discussed.

Click here to read an article that discussed AED's saving 2 High School students, in one week, in the Birmingham News newspaper from February 2003.

Click here to read a news story from February 2003 shown on the Kansas City News titled "Referee Collapses at Basketball Game. Doctor in Audience Uses Defibrillator on Injured Ref."

Informative Articles
Following are some informative articles relating to AED's. Click the title you are interested in to view this article:

Portable Defibrillators Protect Fans, Players at High School Athletic Events
Why do Athletes Experience Sudden Deaths?
Planning for Scholastic Cardiac Emergencies - "The Ripley Project"
A Young Life Saved by a School Defibrillator

Click on the links below to read a 3 day series of articles from the USA Today newspaper on AED's:
http://www.usatoday.com/news/nation/ems-main.htm
http://www.usatoday.com/news/nation/ems-day2-cover.htm
http://www.usatoday.com/news/nation/ems-day3-hero1.htm

Click on the links below to read 3 additional USA Today articles on AED's:
http://www.usatoday.com/usatonline/20031106/5655318s.htm
http://www.usatoday.com/usatonline/20031106/5655319s.htm
http://www.usatoday.com/usatonline/20031106/5655317s.htm
 

 

Warranty
Medtronic Physio-Control provides the following product warranty to the end user. Please contact Medtronic Physio-Control for all warranty questions.

The LIFEPAK 500 includes a 5-year parts & labor warranty. Should the LIFEPAK 500 require service, Medtronic Physio-Control has one of the largest and best-trained networks of Technical Service Representatives in the medical electronics industry. Our Field Service Team is available for on-site service calls 24 hours a day, 7 days a week, 365 days a year. Our response time goal is 2 hours by telephone with a satisfactory conclusion of all service calls within 24 hours. Loaner equipment will be provided if the unit cannot be serviced in the field. Replacement is guaranteed to be 24 hours or less.

Medtronic Physio-Control has one of the largest and best-trained networks of Technical Service Representatives in the medical electronics industry. Our Field Service Team is available for on-site service calls 24 hours a day, 7 days a week, 365 days a year. Our response time goal is to respond with 2 hours by telephone within 2 hours, and bring every service call to a satisfactory conclusion within 24 hours. Loaners of same equipment is available should you ever need to send your device in to the factory. Medtronic Physio-Control is a Certified ISO 9001 manufacturing facility and all of our manufacturing and service processes meet stringent FDA requirements.



Legislation
The FDA has declared Automated External Defibrillators (AEDs) a prescription device. This means, prior to purchase and placement, a prescription or a Medical Authorization Form must be completed and signed by licensed physician. This is a federal law and is required for all defibrillator sales in the United States.

Adobe Acrobat is required to view or print the Medical Authorization Form click the icon below to download a free copy.



For information regarding Automated External Defibrillators in your state click here.



Customer Testimonials
The following is a partial list of elementary, middle and high schools, universities and professional teams that have implemented a public access defibrillation program, and have purchased Medtronic Physio-Control LIFEPAK 500 Automated External Defibrillators:
Elementary, Middle and High Schools
AA Stagg High School, Palos Hills, IL
Prairie Heights High School, La Grange, IN
Naperville North High School, Naperville, IL
Naperville Central High School, Naperville, IL
Community Unit School District 155, Crystal Lake, IL
Community School District 214, Arlington Heights, IL
Hopkins Academy, Hadley, MA
Marlboro High School, Marlboro, NJ
Troy High School, Troy, OH
Ebenezer Elementary School, Lebanon, PA
Penn Tafford High School, Harrison City, PA
Clear Creek Independent School District, Clear Creek, TX
Denton Independent School District, Denton, TX
Oak Creek Senior High School, Oak Creek, WI
Lovett School, Atlanta, GA
Kessling Middle School, La Porte, IN
Carl Sandburg High School, Orland Park, IL
Culver Academy, Culver, IN
Lovett School, Atlanta, GA
Gaston Day School, Gaston, NC
Mundelein High School, Mundelein, IL
San Felipe Del Rio Community Independent School District, Del Rio, TX
Plantation High School, Plantation, FL


Colleges and Universities
University of Illinois/Chicago, Chicago, IL
University of Illinois, Champaign-Urbana
Lewis University, Romeoville, IL
Concordia University, River Forest, IL
Northern Illinois, University DeKalb, IL
Wheaton College, Wheaton, IL
Augustana College, Rock Island, IL
Louisiana State University, Baton Rouge, LA
Indiana State University, Terra Haute, IN
DePaul University, Chicago, IL
Indiana University, Bloomington, IN
Southern Connecticut University, Hamden, CT
Berry College, Mt. Berry, GA
Emory University, Atlanta, GA
Tulane University, New Orleans, LA
Xavier University, Cincinnati, OH
University of Tulsa, Tulsa OK
Tennessee Tech University, Cookeville, TN
Norfolk State University, Norfolk, VA
University of Wisconsin-Parkside, Kenosha, WI
Southern Illinois University, Edwardsville, IL
Auburn University, Auburn, AL
Central College, Pella, IA
Austin Peay University, Clarksville, TN
Coe College, Cedar Rapids, IA
Virginia Tech University, Blacksburg, VA
University of Wisconsin, Madison, WI
University of Kentucky, Lexington, KY

Professional Teams
Milwaukee Bucks
Chicago White Sox
Columbus Blue Jackets
Philadelphia Eagles
Arizona Cardinals
Indianapolis Colts
Philadelphia Flyers
Philadelphia Phantoms
Dallas Stars

   
     
 

Other Information
  Award Information
The National Center for Early Defibrillation (www.early-defib.org) is conducting an award for the best AED program. If you or your school are interested, click here for the award description and application.
Indemnification
Medtronic Physio-Control Corp. agrees to indemnify, defend, save and hold harmless First Owner* of this LIFEPAK 500 AED from any and all liability, loss, cost, expenses (including without limitation reasonable cost of defense), judgments, claims, liens and demands arising directly from personal injuries to patients which occur during the use of this LIFEPAK 500 AED on such patients and which are directly caused, and to the extent such injury is directly caused, but a design or manufacturing defect of this LIFEPAK 500 AED.

*First Owner means the first purchaser or lessee of a LIFEPAK 500 AED, directly or through a group purchasing arrangement, from Medtronic Physio-Control Corp., from a Medtronic Physio-Control Corp., corporate affiliate, or from an authorized Medtronic Physio-Control Corp. dealer, and includes Invoiced Purchaser's corporate affiliates, and their respective employees, officers and directors.
 
Raising Funds
Click here to review ideas about how your school can raise funds to pay for their AED program.

Adobe Acrobat is required to view or print the above document. Click the icon below to download a free copy.


 

Product Ordering Information
SH Catalog # Product Name
54018 LIFEPAK 500 AED Kit #1 with Biphasic Waveform- Two Button Operation
54019 LIFEPAK 500 AED Kit #2 with Monophasic Waveform- Two Button Operation

 

 

 


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