Philips HeartStart Instructions For Use Manual

Philips HeartStart Instructions For Use Manual

Home defibrillator
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H e a r t S t a r t H o m e D e f i b r i l l a t o r
I N S T R U C T I O N S F O R U S E
M5068A
Edition 7

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Summary of Contents for Philips HeartStart

  • Page 1 H e a r t S t a r t H o m e D e f i b r i l l a t o r I N S T R U C T I O N S F O R U S E M5068A Edition 7...
  • Page 2 The HeartStart Home Defibrillator M5068A Pads Cartridge Handle. Information Button. Speaker. This When the device is Pull the handle to turn on the blue “i-button” flashes when it being used, its voice instructions HeartStart and remove the has information you can access by come from this speaker.
  • Page 3 HeartStart Home Defibrillator M5068A QUICK REFERENCE...
  • Page 4 HeartStart Home M5068A Automated External Defibrillator I N S T R U C T I O N S F O R U S E Edition 7 IMPORTANT NOTE: It is important to understand that survival rates for sudden cardiac arrest are directly related to how soon victims receive treatment.
  • Page 5 Device manufacturer 1.866.333.4246 for information on revisions. Philips Medical Systems, Seattle, WA, USA 98121-1825. Edition history NOTE: The Philips HeartStart Home Defibrillator is Edition 7 designed to be used only with Philips-approved Publication date: November 2009 accessories. The HeartStart may perform improperly if Assembly #: 012026-0007 non-approved accessories are used.
  • Page 6: Table Of Contents

    2 SETTING UP THE HEARTSTART Package contents ....................2-1 Setup ........................2-1 Readiness check ....................2-2 Being ready to use The HeartStart ..............2-2 Recommended accessories ................2-4 3 USING THE HEARTSTART Overview ....................... 3-1 STEP 1: PULL the green handle ................ 3-2 STEP 2: PLACE the pads ..................
  • Page 7 APPENDICES A Accessories for the HeartStart B Glossary of terms C Glossary of symbols/controls D Warnings and precautions E Technical information Configuration G Testing and troubleshooting...
  • Page 8: Description

    INDICATIONS FOR USE The HeartStart should be used to treat someone you think may be a victim of SCA. A person in SCA: •...
  • Page 9: Training And Practice

    TRAINING AND PRACTICE The HeartStart comes with training materials, including a training video and an Owner’s Manual, which should be reviewed by anyone who may use the defibrillator. Reusable accessories are available from Philips for practicing use of the HeartStart.
  • Page 10: Setting Up The Heartstart

    SETTING UP THE HEARTSTART PACKAGE CONTENTS Check the contents of the HeartStart Home Defibrillator box to be sure it contains: • 1 HeartStart Defibrillator M5068A • 1 battery M5070A, pre-installed • 1 Adult SMART Pads Cartridge M5071A, pre-installed containing one set of adhesive defibrillation pads •...
  • Page 11: Readiness Check

    READINESS CHECK If the HeartStart Home Defibrillator is correctly set up, it will now be in “standby mode” and the green Ready light will be blinking. This means the defibrillator has passed its most recent self-test and is therefore ready to use.
  • Page 12 Store the defibrillator where the temperatures stay between 50° and 109° F (10° and 43° C). Do not keep the HeartStart in the trunk of a car for long periods if you live in a very hot or cold climate.
  • Page 13: Recommended Accessories

    — to dry the victim's skin for good pads contact Philips has a Fast Response Kit with all these items. See Appendix A for details. If you may need to defibrillate an infant or a child under 25 kg (55 pounds) or 8 years old, it is recommended that you order the Infant/Child SMART Pads Cartridge, available separately at www.HeartStart Home.com or by calling 1.866.333.4246.
  • Page 14: Using The Heartstart

    Call your emergency services provider. • Quickly get the HeartStart and bring it to the victim’s side. If there is any delay in getting the defibrillator, check the patient and perform cardiopulmonary resuscitation (CPR) if needed until the HeartStart is available.
  • Page 15: Step 1: Pull The Green Handle

    The HeartStart starts by directing you to remove all clothes from the patient’s chest. If necessary, rip or cut off the clothing to bare the person’s chest * You can also turn on the HeartStart by pressing the green On/Off button.
  • Page 16: Step 2: Place The Pads

    STEP 2: PLACE THE PADS Pull the tab at the top of the pads cartridge to peel off the film seal. Inside are two adhesive pads on a plastic liner. Remove the pads from the cartridge. Peel one pad off the liner. Place the pad on the patient’s bare skin, exactly as shown in the picture on the pad.
  • Page 17: Step 3: Press The Shock Button

    STEP 3: PRESS THE SHOCK BUTTON As soon as the HeartStart detects that the pads are attached to the patient, it begins analyzing the patient’s heart rhythm. It tells you that no one should be touching the patient, and the Caution light begins flashing as a reminder.
  • Page 18: Treating Infants And Children

    CPR Coaching. Place the pads exactly as shown on the illustration on the pads. * Philips recommends that the HeartStart be stored with an adult pads cartridge installed, as pediatric cardiac arrest is not common. † This lower energy level may not be effective for treating an adult.
  • Page 19: When Emergency Medical Services Arrive

    Remove all clothing from the torso, to bare both the chest and the back. • Apply the HeartStart using the adult pads cartridge, but place one pad in the center of the chest between the nipples, and the other in the center of the back (anterior-posterior).
  • Page 20 Do not touch the patient or the pads while the Caution light is on solid or flashing. If the HeartStart is unable to analyze due to electrical “noise” (artifact), it will tell you to stop all movement and remind you not to touch the patient.
  • Page 21: After Using The Heartstart

    * If you leave the battery in the HeartStart after using the defibrillator, then transfer the last-use data to a computer running HeartStart Event Review software, the software will calculate the local date and time of the device use.
  • Page 22 The HeartStart will tell you how many shocks were delivered and how long it has been since it was turned on. Summary data are available anytime the defibrillator is ready for use (the battery and pads are installed, and the defibrillator is not turned on) or while it is actually in use.
  • Page 23: Maintaining The Heartstart

    Chapter 2, “Setting up the HeartStart.” • The HeartStart runs daily self-tests. As long as the green Ready light is blinking, it is not necessary to test the defibrillator by initiating a battery insertion self-test.
  • Page 24: Changing The Pads Cartridge

    Install the new cartridge: slide the bottom end of the cartridge into the recess, then press in the cartridge until the latch clicks into place. Be sure the green handle is pressed down firmly. The HeartStart will tell you what kind of pads...
  • Page 25: Replacing The Battery

    (If for any reason the self-test does not pass, press the blue i-button for information and refer to the Troubleshooting information in Chapter 6.) Check the green Ready light to make sure it is blinking. Your HeartStart Home Home Defibrillator is ready for use.
  • Page 26: Cleaning The Heartstart

    Your HeartStart Home Home Defibrillator is ready for use. CLEANING THE HEARTSTART The outside of the HeartStart and its carry case can be cleaned with a soft cloth dampened in soapy water, chlorine bleach (2 tablespoons per quart or liter of water), or ammonia-based cleaners.
  • Page 27: Troubleshooting Tips

    • If the Ready light is solid: The HeartStart is in use or running a self-test. • If the Ready light is off, the HeartStart is chirping, and the i-button is flashing: A self-test error has occurred, there is a problem with the pads or the battery power is low.
  • Page 28 2 pairs of gloves, a pair of paramedics scissors, and an absorbent wipe) • HeartStart Defibrillator Quick Reference Guide [REF: M5066-97800] To order any of these and other accessories, call Philips at 1.866.333.4246 or visit us on-line at www.HeartStartHome.com. * Available by prescription only. Talk to your doctor.
  • Page 29 Basic Life Support. Caution light A triangular light on the front of the HeartStart that flashes during rhythm analysis and is on solid when a shock is advised, as a reminder not to touch the patient. configuration The settings for all operating options of the HeartStart, including treatment protocol.
  • Page 30 HeartStart configuration. Information is available from Philips Medical Systems on the internet at www.philips.com/eventreview. i-button A blue “information” button on the front of the HeartStart. If the i-button is pressed during the 30 seconds it flashes during a patient care pause, the HeartStart provides CPR Coaching;...
  • Page 31 Ready light A green LED showing the readiness for use of the HeartStart. A blinking Ready light means the defibrillator is ready for use; a solid Ready light means the defibrillator is being used.
  • Page 32 The operating mode of the HeartStart when a battery has been installed, and the unit is turned off and ready for use when needed. Shown by blinking green READY light. standard NSA pause See “NSA pause.” sudden cardiac arrest The sudden stopping of the heart’s pumping rhythm, accompanied by loss of...
  • Page 33 GLOSSARY OF SYMBOLS/CONTROLS symbol description Pads cartridge handle. Green. Pulling the handle turns on the OnSite and opens pads cartridge for use. Refer to operating instructions. On/Off button. Green. Pressing the On/Off button when the OnSite is in standby mode turns the OnSite on; pressing and holding the On/Off button for one second when the OnSite is on turns the OnSite off and disarms the defibrillator.
  • Page 34 symbol description Indicates that this device is optimized for Guidelines 2005. Certified by the Canadian Standards Association. Reference order number. Authorized representative in the European Community. Expiration date. Lithium manganese dioxide battery. One battery in package. Do not crush the battery. Do not expose the battery to high heat or open flames.
  • Page 35 symbol description This side up. Transportation requirements (refer to associated ther- mometer symbol). Storage requirements (refer to associated thermometer symbol). Environmental (temperature and relative humidity) requirements. These pads are disposable and are for single patient use only. Cartridge contents: one set of two defibrillation pads. Store the pads at temperatures between 0°...
  • Page 36 symbol description Lot number. Federal law (USA) restricts this device to sale by or on the order of a physician. Dispose of in accordance with your country's require- ments. Printed on recycled paper.
  • Page 37 WARNINGS flammable gases If the HeartStart is used to give a shock in the presence of flammable gases such as in an oxygen tent, there is a risk of explosion. Move supplemental oxygen and oxygen delivery devices away from the defibrillation pads. (However, it is safe to use the HeartStart on someone wearing an oxygen mask.)
  • Page 38 PRECAUTIONS device handling The HeartStart was designed to be sturdy and reliable for many different use conditions. However, handling the HeartStart too roughly can damage it or its accessories and will invalidate the warranty. Check the HeartStart and accessories regularly for damage, according to directions.
  • Page 39 TECHNICAL INFORMATION HEARTSTART SPECIFICATIONS The specifications provided in the following tables are nominal values. Additional information can be found in the Technical Reference Manual for HeartStart Automated External Defibrillators, located online at www.philips.com/ productdocs. PHYSICAL category specifications size 2.80” H x 7.40” D x 8.30” W (7.1cm H x 19cm D x 21cm W).
  • Page 40 category specifications sealing Drip proof per EN60529 class IPx1. Solid Objects per EN60529 class IP2x. ESD/EMI (radiated and See Electromagnetic Conformity tables. immunity) CONTROLS AND INDICATORS category specifications controls Green SMART Pads cartridge handle Green On/Off button Blue i-button Orange Shock button indicators Ready light: green;...
  • Page 41 D is the duration of phase 1 and E is the duration of phase 2 of the waveform, F is the interphase delay (500 μs), and Ip is the peak current. The HeartStart OnSite delivers shocks to load impedances from 25 to 180 ohms.
  • Page 42 ± energy* Using HeartStart Adult SMART Pads: 150 J nominal ( 15%) into a 50 ohm load. ± (pediatric doses indicated Using HeartStart Infant/Child SMART Pads: 50 J nominal ( 15%) into a 50 ohm are based on CDC growth load.
  • Page 43 Ventricular fibrillation (VF) and some ventricular tachycardias associated with a lack of circulation, including ventricular flutter and polymorphic ventricular tachycardia (VT). The HeartStart uses multiple parameters to determine if a rhythm is shockable. NOTE: For patient safety reasons, some very low-amplitude or low-frequency rhythms may not be interpreted as shockable VF rhythms.
  • Page 44 (meets AAMI DF80 requirement) rhythms a. From Philips Medical Systems Heartstream ECG rhythm databases. b. American Heart Association (AHA) AED Task Force, Subcommittee on AED Safety & Efficacy. Automatic External Defibrillators for Public Access Use: Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance, Incorporation of New Waveforms, and Enhancing Safety.
  • Page 45 40 inch (101.6 cm), typical, cable. Cartridge incorporates teddy bear icon on cover of seal for ready identification. defibrillation pad Use only HeartStart Adult SMART Pads M5071A or Infant/Child SMART Pads requirements M5072A with the HeartStart.
  • Page 46 ENVIRONMENTAL CONSIDERATIONS By complying with your national regulations regarding disposal of electric, electronic, and battery waste, you can make a positive contribution to our shared environment. Such waste can introduce harmful elements into the environment as a whole and may also endanger human health product information defibrillator...
  • Page 47 CONFIGURATION OVERVIEW The HeartStart comes with a factory default configuration designed to meet the needs of most users. This configuration can only be changed by an authorized person using HeartStart Configure PDA software or Event Review software. This software is for use by trained personnel. Information about HeartStart data management products is available online at www.philips.com/eventreview.
  • Page 48 1 shock. * A shock series begins when a shock is delivered after the HeartStart is turned on. A new shock series begins after a protocol pause. If shock series is configured for 2 or more, a new shock series also begins if the time since the previous...
  • Page 49 SMART NSA pause and resumes rhythm analysis. • SMART NSA pause: HeartStart con- NOTE: If the HeartStart detects CPR in ducts background progress or if the responder has pressed monitoring during the i-button for CPR Coaching, the SMART the SMART NSA NSA pause will be converted to a pause.
  • Page 50 (NSA). If the user presses the i-button for optional CPR coaching, the HeartStart provides coaching for 5 cycles of CPR, starting and ending with compressions, when the CPR Coaching parameters are also set to their default values.
  • Page 51 CPR Coaching during a ratio child protocol pause or NSA pause, the • 30:2 adult and HeartStart provides coaching in basic 15:2 infant/child CPR for cycles of 30 compressions and • 15:2 adult and 2 ventilations for adults, children, and 15:2 infant/child infants.
  • Page 53 RECOMMENDED ACTION DURING AN EMERGENCY If for any reason the HeartStart does not turn on when you pull the SMART Pads cartridge handle, press the On/Off button. If that does not turn on the defibrillator, remove the battery and replace it with a...
  • Page 54 If the problem continues, do not use the HeartStart. Attend to the patient, providing CPR if needed, until Emergency Medical Services Personnel arrive.
  • Page 55 HeartStart tells you: possible cause recommended action ... to stop all motion • The patient is being moved or • Stop CPR; do not touch the patient. jostled. Minimize patient motion. If the patient is being transported, stop the vehicle.
  • Page 56 TROUBLESHOOTING WHILE THE HEARTSTART IS NOT IN USE (green Ready light is not on) behavior possible cause recommended action chirps or • The battery power is low or the • Press the blue i-button. Replace i-button flashes SMART Pads cartridge needs to be the battery or pads cartridge if replaced.
  • Page 57 P O W E R S A V E L I F E Philips Medical Systems is part of Philips Medical Systems Royal Philips Electronics United States Philips Medical Systems 2301 Fifth Avenue, Suite 200 Seattle, WA, USA 98121-1825 (800) 263-3342...

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M5068a

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