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School Health-Product Education-LIFEPAK CR Plus Defibrillator
 
LIFEPAK CRPlus Defibrillator

Introduction
Product Overview and Description
Product Use and Procedure
Features and Benefits
FAQ's
Technical Specifications
Articles / Sales Brochures / Manual
Warranty
Product Ordering Information
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Introduction

LIFESAVING MADE SIMPLE - As many as 7,000 children are struck down by sudden cardiac arrest each year, unexpectedly robbed of the chance to fulfill their dreams. In addition, schools are community centers, with people of all ages coming and going. Although undetected heart problems are a common cause of sudden cardiac arrest, many victims are active and outwardly fit. This is a fact we would like to change, with your help. Medtronic, the world leader in medical technology, created the LIFEPAK CR Plus defibrillator specifically for the first person at the scene of a sudden cardiac arrest. Designed for the minimally trained and infrequent rescuer, it's easy to understand and use in a cardiac emergency, when every second counts. It's just plain simple.




Product Overview and Description
The CR Plus offers the quality and performance preferred by the vast majority of emergency medical teams around the world. Sleek and lightweight, the CR Plus uses the latest ADAPTIV™ biphasic technology, upholds the standards of excellence found in all LIFEPAK products, and continues the LIFEPAK legacy of 1-2-3-step* operation.



Product Use and Procedure
The LIFEPAK CR Plus enables you to give a defibrillation shock that could save a life. Once you determine the person isn't breathing or conscious, you just:

1. Push the button to release the lid and turn on the defibrillator.
2. Pull the handle to get the electrode pads and adhere them to the person's chest as shown.
3. Press the flashing button if told to do so.*
* Also available in automatic mode, which requires only steps 1-2.



Features and Benefits

Features
1. Easy 1-2-3-step operation
2. Semi-automatic or fully automatic configurations
3. Proven, flexible
4. ADAPTIV™ biphasic technology
5. Unique, cost-effective power system
6. Lightweight and compact
7. Highly visible readiness indicator
8. Wireless data transfer and storage technology
9. QUIK-PAK™ pacing/ defibrillation/ECG electrodes enable fast accurate use

Benefits
1. Simple to use - Because sudden cardiac arrest can happen anywhere, anytime, a layperson is often the first person on-scene. The CR Plus is designed so that a minimally trained person with limited or no experience can use it in an emergency. You can give lifesaving treatment in just three steps. The CR Plus tells you exactly what to do. QUIK-PAK™ electrodes are pre-connected and easy to open and apply, with pictures showing you how to adhere them quickly and properly.
2. Semiautomatic vs. fully automatic - YOUR CHOICE! With the semiautomatic CR Plus you assess the person in sudden cardiac arrest, then open the device and apply the electrodes. The device analyzes the heart's rhythm and tells you to push a button if the heart needs a shock. The fully automatic CR Plus requires just the first two steps, and the device does the rest.
3. The latest technology - Medtronic's ADAPTIV biphasic technology automatically adjusts therapy to meet each person's needs. The device can provide additional, higher energy shocks, up to 360 joules, if the heart doesn't respond to the first shock. This can enhance the chance of defibrillation success, with the goal of saving more lives.
4. Infant/Child Reduced Energy Defibrillation Electrodes - Infant/Child Reduced Energy Defibrillation Electrodes Compatibility - use only with LIFEPAK 500 AEDs with a pink connector or any LIFEPAK CR Plus defibrillator. Intended for use on children up to 8 years of age or 25kg (55lb). The Infant/Child Reduced Energy Electrode is smaller than adult defibrillation electrodes. The electrode reduces the energy dose that is delivered to the patient by a factor of four. If the AED is set up to deliver a dosage of 200, 300, 360J using adult defibrillation pads, the dosage will be approximately 50, 75, 86J with the Infant/Child Reduced Energy Electrodes.




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 AEDs important?
A: AEDs 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 AEDs 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 AEDs 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. At 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 AEDs 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: AEDs 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

Waveform: Biphasic truncated exponential, with voltage and current duration compensation for patient impedance.*
Output Energy Sequence: Multiple levels, user configurable from 200J to 360J (150J min. outside the U.S.).
Output Energy Accuracy: ±10% into 50 ohms, ±15% into 25 to 100 ohms.
Shock Advisory System: An ECG analysis system that advises whether a shock is appropriate; meets rhythm recognition criteria specified in DF39. The device charges for shock only when the Shock Advisory System advises defibrillation.
Device Capacity:
Typical: Thirty (30) full discharges or 210 minutes of "on time" with a fully charged device.
Minimum: Twenty (20) full discharges or 140 minutes of "on time" with a fully charged device.
Shock Charge Time: Charge times with a fully charged device: 200 joules in less than 9 seconds, 360 joules in less than 15 seconds.
System Recharge Times: Recharge times with a fully discharged device: able to deliver six (6) shocks or provide 42 minutes of operating time after 48 hours of recharge and 20 shocks or 140 minutes of operating time after fourteen (14) days of recharge time with a new CHARGE-PAK at temperatures above 15° C (59° F).
Controls: Lid Release/ON-OFF - Controls device power. SHOCK button (semi-automatic version) - delivers defibrillation energy. After electrodes are attached to a patient, the fully automatic version of the device delivers a shock, if appropriate, not requiring operator intervention.
Electrical Protection: Input protected against high voltage defibrillator pulses per IEC60601-1/EN60601-1.
Safety Classification: Internally powered equipment. IEC60601-1/EN60601-1.
User Interface: The user interface includes voice prompts, audible tones and graphic prompts.
Readiness Display: The readiness display shows the device status.
OK Indicator: Shows "OK" when the last self-test was completed successfully. When the "OK" indicator is visible, all other indicators are not visible. The "OK" indicator is not displayed during device operation.
CHARGE-PAK Indicator: When displayed, replace the CHARGE-PAK battery charger.
Attention Indicator: When first displayed, at least six (6) discharges or 42 minutes of operating time remain.
Service Indicator: Service required when displayed.
Note: All performance specifications defined assume the unit has been stored (two hours minimum) at operating temperature prior to operation.
Operating Temperature: 0° to +50° C (+32° to +122° F).
Storage Temperature: -40° to +70° C (-40° to +158° F) with CHARGE-PAK and electrodes, maximum exposure time limited to one week.
Atmospheric Pressure: 760 mmHg to 429 mmHg, 0 to 15,000 feet above sea level.
Relative Humidity: 5 to 95% (non-condensing).
Water Resistance: IEC60529/EN60529 IPX4 "Splash proof" with electrodes connected, CHARGE-PAK installed.
Shock: MIL-STD-810E, Method 516.4, Procedure 1, (40g, 6-9 ms pulse, 1/2 sine each axis).
Vibration: MIL-STD-810E, Method 514.4, Helicopter - category 6 (3.75 Grms) and Ground Mobile - category 8 (3.15 Grms).
Height: 10.7 cm (4.2 in).
Width: 20.3 cm (8.0 in).
Depth: 24.1 cm (9.5 in), excluding handle.
Weight: 2.0 kg (4.5 lb) with CHARGE-PAK and electrodes.
Energy Sequence: Users can choose an energy sequence to match their applicable energy protocol (e.g. 200J, 300J, 360J).
Motion Detection: The motion detection system can be set to off or on during analysis.
Energy Protocol: The user can configure the defibrillator to increase energy after every shock or only increase it after a lower energy was unsuccessful.
Turn-On Prompt: The turn-on prompt option allows the user to select the prompting style upon power on.
CPR Time: The CPR Time can be set to match local protocol.
Pulse Prompt: The pulse prompt option allows the user to select the voice message for CPR prompting according to the Guidelines 2000, as recommended by the American Heart Association (AHA) and the International Liaison Committee on Resuscitation (ILCOR).
Voice Prompt Volume: The voice prompt volume option allows changing the speaker volume.
Time/Date: The time and date can be changed.
Device ID: The device ID feature assigns a unique identifier to a particular device, which is printed on all reports.
Note: Setup items are changed over a wireless interface. See the operating instructions for setup information instruction.
CHARGE-PAK Battery Charger
Type: Li/SO2Cl2 Lithium Sulfuryl Chloride, 11.7V, 1.4 amp-hours.
Replacement: Replace after each patient use, or when CHARGE-PAK indicator is visible, typically after two (2) years.
Weight: 80.5 grams (0.18 lb).
QUIK-PAK Electrode Pads
Pads: ECG is received from disposable defibrillation electrodes, standard placement (anterior-lateral).
Pads Packaging: User intuitive, rapid release QUIK-PAK electrodes allow the electrode pads to be preconnected to the device and protected under a top cover.
Pads Replacement: Replace every two (2) years.
Memory Type: Internal digital memory.
ECG Storage: Dual patient data storage. Minimum 20 minutes of ECG stored for the current patient, summarized data stored for the previous patient.
Report Types:
  • Continuous ECG - A continuous patient ECG report.
  • Continuous Summary report - A summary of critical resuscitation events and ECG waveform segments associated with these events.
  • Event Log report - A report of time stamped markers, which reflect operator and device activity.
  • Test Log report - A device self-test activity report.
Capacity: Minimum 200 time-stamped event log markers.
Communications: Wireless transfer to a personal computer.
Data Review: Medtronic provides an array of tools to meet customer needs for data viewing and analysis.
* The specifications apply from 25 to 200 ohms. Voltage compensation is limited to the voltage that would result in delivery of 360 joules into 50 ohms.
All specifications are at 20° C unless otherwise stated.




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).

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
99-378 Medtronic: LIFEPAK CR Plus Product Specs
99-374 Medtronic: LIFEPAK CR Plus Trainers Specs
99-293 Medtronic: Is Your Community Heart Safe
99-408 Medtronic: Saving More Lives - At Any Age
99-380 Medtronic: LIFEPAK CR Plus Defibrillator Product Brochure
99-314 Medtronic: Wall Cabinets for LIFEPAK CR Plus
99-428 Medtronic: AED Program Implementation Guide For Schools
99-434 LIFEPAK AEDs - Saving Lives In Schools Answers to Your Questions
99-438 Medtronic: Keep your Athletes in the Most Important Game

School News Clippings
Following are some "News Bytes" relating to AEDs:

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 AEDs. 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 AEDs:
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
The Lifepak CR Plus comes with a 5-year warranty.



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.



Product Ordering Information

SH Catalog # Product Name
54044 Lifepak CR Plus AED - Semi Automatic
54045 Lifepak CR Plus AED - Fully Automatic

 

 


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