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H E A R T S T A R T F R x D E F I B R I L L A T O R
O W N E R ' S M A N U A L
861304
Edition 8
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Summary of Contents

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    H E A R T S T A R T F R x D E F I B R I L L A T O R O W N E R ’ S M A N U A L 861304 Edition 8...

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    HeartStart FRx Defibrillator QUICK REFERENCE...

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    Intentionally blank.

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    HeartStart FRx 861304 Automated External Defibrillator O W N E R ’ S M A N U A L Edition 8 IMPORTANT NOTE: It is important to understand that survival rates for sudden cardiac arrest are directly related to how soon victims are defibrillated. For every minute of delay, the chance of survival declines by 7% to 10%.

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    CAUTION FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. The Philips HeartStart is designed to be used only with Philips-approved accessories. The HeartStart may perform improperly if non-approved accessories are used. Device Tracking In the USA, this device is subject to tracking requirements by the manufacturer and distributors.

  • Page 7: Table Of Contents

    CONTENTS 1 Introduction to the HeartStart FRx Description ... Sudden Cardiac Arrest ... Indications for Use ... Training and practice ... State and local requirements ... For more information ... 2 Setting up the HeartStart FRx Package contents ... Setting up the FRx ... Recommended accessories ...

  • Page 8: Table Of Contents

    B Glossary of terms ... C glossary of symbols/controls ... D Warnings and Precautions ... E Technical information ... Configuration ... G Testing and troubleshooting ... H Additional technical data required for European conformity ... HEARTSTART FRx 861304 OWNER’S MANUAL...

  • Page 9: Description, Sudden Cardiac Arrest

    Introduction to the HeartStart FRx Description The Philips HeartStart FRx Defibrillator 861304 (“FRx”) is an automated external defibrillator (AED). Small, lightweight, rugged, and battery powered, it is designed for simple and reliable operation by minimally trained users. The FRx is highly configurable for local protocol considerations.

  • Page 10: Indications For Use, Training And Practice, State And Local Requirements

    (CPR) and defibrillator use. Philips recommends that you train on the device you will be using. Several national and local organizations offer combined CPR/ defibrillator training. Contact your Philips representative, or visit us on-line at www.medical.philips.com/heartstart, for information about training programs in your area.

  • Page 11: For More Information, Package Contents

    For more information Contact your local Philips distributor for additional information about the FRx. We will be happy to answer any questions you may have and to provide you with copies of the clinical summaries of several key studies using Philips automated external defibrillators.

  • Page 12: Setting Up The Frx

    * Unless otherwise noted, references to pads in this document are to HeartStart HEARTSTART FRx 861304 OWNER’S MANUAL (A). Do not open the pads case until you need to use the pads in an emergency. Plug the pads cable connector into the connector port on the FRx (B).

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    instructed. When the self-test is over, the FRx will report the results, then turn off and go to standby mode. The blinking green Ready light shows the defibrillator is ready for use. 4. Place the Quick Reference Guide, a brief illustrated guide for using the FRx to treat a victim of sudden cardiac arrest, in the †...

  • Page 14: Recommended Accessories

    • • • 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 55 pounds (25 kg) or 8 years old, it is recommended that you order the Infant/Child Key accessory, available separately.

  • Page 15: Overview

    Using the HeartStart FRx IMPORTANT NOTE: Be sure to read the Reminders section at the end of this chapter as well as the warnings and precautions in Appendix D. Overview If you think someone is in SCA, act quickly and calmly. If someone else is available, ask him or her to call for emergency medical assistance while you get the FRx.

  • Page 16: Step 1: Press The Green On/off Button, Step 2: Follow The Frx's Voice Instructions

    FRx front panel will be flashing, to help guide you. Place the pad on the patient’s bare skin exactly as shown in the following drawing. Press the adhesive portion of the pad down firmly. Then repeat this with the other pad. Pads icons flash. HEARTSTART FRx 861304 OWNER’S MANUAL...

  • Page 17: Step 3: Press The Flashing Orange Shock Button If Instructed

    Where to place pads on infants or Where to place pads on adults and children over children under 55 pounds or 55 pounds or 8 years old (anterior-anterior). 8 years old (anterior-posterior). STEP 3: Press the flashing orange Shock button if instructed As soon as the HeartStart FRx detects that the pads are attached to the patient, the pads icons turn off.

  • Page 18: Treating Infants And Children

    FRx. calling EMS and retrieving the FRx. then get the FRx. the i-button in this situation; however, the default setting can be revised by your Medical Director using Philips software available separately. See Appendix F for more information. I-button...

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    If the victim is under 55 pounds or 8 years old, and you have an Infant/Child Key: • • • Insert the Infant/Child Key if available. NOTE: It does not matter whether you insert the Infant/Child Key before or immediately after turning on the FRx. However, the Key should be inserted before placing the pads on the patient.

  • Page 20: When Emergency Medical Services Arrive

    FRx to service, to be sure it is ready for use. * See Chapter 4, “After Using the HeartStart FRx,” for details about data storage. HEARTSTART FRx 861304 OWNER’S MANUAL DO NOT DELAY TREATMENT. Turn on the FRx and follow instructions to remove all clothing from the torso, to bare both the chest and the back.

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    Reminders • Remove any medicine patches and residual adhesive from the patient’s chest before applying the pads. • Do not place the pads directly over an implanted pacemaker or defibrillator. A noticeable lump with a surgical scar should indicate the position of an implanted device. •...

  • Page 22: After Each Use

    * If you leave the battery in the FRx after using the defibrillator, then transfer the HEARTSTART FRx 861304 OWNER’S MANUAL contamination. If you see signs of damage, contact Philips for technical support. If the defibrillator is dirty or contaminated, clean it according to the guidelines in Chapter 5, “Maintaining the...

  • Page 23: Frx Data Storage

    The stored data can be conveniently transferred to a personal computer or a handheld computer running the appropriate application in the Philips HeartStart Event Review data management software suite. Event Review software is for use by trained personnel only. Information about HeartStart Event Review is available online www.medical.philips.com/goto/eventreview.

  • Page 24: Routine Maintenance

    Reminders: • • • HEARTSTART FRx 861304 OWNER’S MANUAL the FRx’s status (entire incident) the FRx’s rhythm analysis decisions (entire incident) the elapsed time associated with stored events (entire incident) Do not leave the defibrillator without a set of pads connected;...

  • Page 25: Periodic Checks, Cleaning The Frx, Disposing Of The Frx

    Replace any used, damaged or expired supplies and accessories. • Check the outside of the defibrillator. If you see cracks or other signs of damage, contact Philips for technical support. Cleaning the FRx The outside of the HeartStart FRx can be cleaned with a soft cloth...

  • Page 26: Troubleshooting Tips

    • More detailed testing and troubleshooting information is available in Appendix G. HEARTSTART FRx 861304 OWNER’S MANUAL If the Ready light is blinking: The FRx has passed the battery insertion self-test and the last periodic self-test and is therefore ready for use.

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    APPENDICES A Accessories B Glossary of terms C Glossary of symbols/controls D Warnings and precautions E Technical information F Configuration G Testing and troubleshooting H Additional technical data required for European conformity...

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    Notes HEARTSTART FRx 861304 OWNER’S MANUAL...

  • Page 29: A Accessories

    Accessories Accessories* for the HeartStart FRx Defibrillator 861304 available separately from your local Philips representative or online at www.medical.philips.com/heartstart include. • Batteries (spare is recommended) • Battery [REF: M5070A] • Aviation applications battery [REF: 989803139301] • HeartStart SMART Pads II [REF: 989803139261] (spare is recommended) •...

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    • • • • HEARTSTART FRx 861304 OWNER’S MANUAL HeartStart Training Pads II (kit containing one set of Training Pads II in training pads case, adult pads placement guide, Instructions for Use, and illustrated guide) [REF: 989803139271] Replacement Training Pads II (pair of training pads on disposable liner for...

  • Page 31: B Glossary Of Terms

    Glossary of terms The terms listed in this Glossary are defined in the context of the Philips HeartStart FRx Defibrillator 861304 and its use. Automated external defibrillator (a semi-automatic defibrillator). AED mode The standard treatment mode for the HeartStart FRx Defibrillator. It provides voice instructions guiding the rescuer through applying the adhesive pads, waiting for rhythm analysis, and delivering a shock if needed.

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    A suite of data management software applications for use by trained personnel to review and analyze FRx Defibrillator patient use and by authorized personnel to alter FRx configuration. Information is available from Philips Medical Systems on the internet at http://www.medical.philips.com/goto/eventreview.

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    On/Off button A green button located on the front of the HeartStart FRx Defibrillator. Pressing the On/Off button when the defibrillator is in standby mode turns the defibrillator on; pressing and holding the On/Off button for one second when the defibrillator is on turns the defibrillator off and disarms the defibrillator.

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    NSA pause See “NSA pause.” sudden cardiac arrest The sudden stopping of the heart’s pumping rhythm, accompanied by loss of (SCA) consciousness, absence of respiration, and lack of a pulse. waveform See “SMART biphasic waveform.” HEARTSTART FRx 861304 OWNER’S MANUAL...

  • Page 35: C Glossary Of Symbols/controls

    Glossary of symbols/controls symbol description On/Off button. Green. Pressing the On/Off button when the defibrillator is in standby mode turns the defibrillator on; pressing and holding the On/Off button for one second when the defibrillator is on turns the defibrillator off and disarms the defibrillator.

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    Meets the requirements of the European medical device directives 93/42/EEC. Meets the requirements of the applicable European directive. Printed on recycled paper. Storage requirements (refer to associated thermometer symbol). Transportation requirements (refer to associated thermometer symbol). HEARTSTART FRx 861304 OWNER’S MANUAL...

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    symbol description Environmental (temperature and relative humidity) requirements. Install the battery in the defibrillator before the date (MM-YYYY) shown on the associated label. Reference order number. Serial number. Lot number. Date of manufacture (989803139301 only) Class 9 miscellaneous dangerous goods. (Symbol required on outer packaging by freight carrier regulations to identify shipments containing lithium batteries.) On HeartStart SMART Pads II (989803139261 only).

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    Not for use with Laerdal defibrillator models 911, 1000, 2000, or 3000. Not for use with HeartStart HS1 defibrillators, including HeartStart Home and HeartStart OnSite. Fits Philips HeartStart designated connector ports, including FR2+ and MRx. Pads placement illustration. For use on infants and children under 55 pounds (25 kg).

  • Page 39: D Warnings And Precautions

    FRx, loss of data stored in the FRx, or less chance of successful defibrillation. NOTE: The HeartStart FRx Defibrillator is designed to be used only with Philips-approved accessories. The FRx may perform improperly if non- approved accessories are used. Warnings...

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    Before delivering a shock, it is important to disconnect the patient from other medical electrical equipment, such as blood-flow meters, that may not incorporate defibrillation protection. In addition, make sure the pads are not in contact with metal objects such as a bed frame or stretcher. HEARTSTART FRx 861304 OWNER’S MANUAL...

  • Page 41: E Technical Information

    Technical information HeartStart FRx 861304 Defibrillator specifications The specifications provided in the following tables are nominal values. Additional information can be found in the Technical Reference Manual for HeartStart Defibrillators, located online at www.medical.philips.com. Physical category specifications size 2.4” H x 7.1” D x 8.7” W (6 cm H x 18 cm D x 22 cm W).

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    Provides voice instructions and warning tones during normal use. beeper Provides chirps when troubleshooting is needed. status indicator Status indicator LCD displays device readiness for use. low battery detection Automatic during daily periodic self-testing. low battery indicator Alarm chirps and flashing blue in-button. HEARTSTART FRx 861304 OWNER’S MANUAL...

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    Defibrillation waveform category nominal specifications waveform parameters Biphasic truncated exponential. Waveform parameters are automatically adjusted as a function of patient defibrillation impedance. In the diagram at left, 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.

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    Via SMART Pads II placed in the anterior-anterior (Lead II) position. infant/child shock delivery Via SMART Pads II typically placed in the anterior-posterior position. vector HEARTSTART FRx 861304 OWNER’S MANUAL energy dose newborn 14 J/kg 1 year...

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    ECG analysis system category specifications function Evaluates impedance of adhesive pads for proper contact with patient skin, and evaluates the ECG rhythm and signal quality to determine if a shock is appropriate. shockable rhythms Ventricular fibrillation (VF) and some ventricular tachycardias, including ventricular flutter and polymorphic ventricular tachycardia (VT).

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    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.

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    M5070A battery and 989803139301 TSO C-142* battery category specifications battery type 9 VDC, 4.2 Ah, lithium manganese dioxide. Disposable, long-life primary cell. capacity When new, a minimum of 200 shocks or 4 hours of operating time at 25° C (77° F). (IEC 60601-2-4, 2002) shelf life A minimum of 5 years from date of manufacture when stored and maintained (prior to insertion)

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    User's Guide/Instructions for Use/Owner's Manual. Recycle the battery at an appropriate recycling facility. pads The used pads may be contaminated with body tissue, fluid, or blood. Dispose of them as infectious waste. Recycle the case at an appropriate recycling facility. HEARTSTART FRx 861304 OWNER’S MANUAL...

  • Page 49: F Configuration

    Configuration Overview The Philips HeartStart FRx Defibrillator comes with a factory default configuration designed to meet the needs of most users. This configuration can only be changed by using HeartStart Configure version 1.0 or higher, Event Review version 3.2 or higher, or Event Review Pro 3.1 or higher.

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    * A shock series begins when a shock is delivered after the FRx 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 shock exceeds the shock series interval setting. HEARTSTART FRx 861304 OWNER’S MANUAL settings default...

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    parameter settings protocol pause timer 0.5, 1.0, 1.5, (minutes) 2.0, 2.5, 3.0 NSA pause type • Standard NSA pause: FRx does not perform rhythm analysis during the NSA pause. • SMART NSA pause: FRx conducts background monitoring during the SMART NSA pause. If a potentially shockable rhythm is detected, FRx terminates the SMART...

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    * If the shock series is configured to 2 or more, and a shock has been delivered as part of a series, the length of the first NSA pause interval within that shock series is determined by the protocol pause timer setting. Otherwise, the length of an NSA pause is determined by the NSA pause timer setting. HEARTSTART FRx 861304 OWNER’S MANUAL settings default 0.5, 1.0, 1.5,...

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    parameter CPR Coaching adult ventilation instruction CPR Coaching infant/child ventilation instruction CPR Coaching • 30:2 adult and compression:ventilation 30:2 infant/child ratio • 30:2 adult and 15:2 infant/child • 15:2 adult and 15:2 infant/child settings default yes, no yes, no 30:2 adult and 30:2 infant/ child default description...

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    The HeartStart FRx Defibrillator automatically tests its battery, connected SMART Pads II, and internal circuitry every day. It alerts you if it finds a problem. See the Technical Reference Guide, available online at www.medical.philips.com/heartstart, for a detailed discussion of the self-tests.

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    If the FRx does not turn on when you press the On/Off button, remove the battery and replace it with a new battery if available and press the On/Off button to turn on the defibrillator. If no spare battery is available, remove the installed battery for five seconds, then reinsert it and run a battery insertion self-test.

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    Shock has been advised but the shock not pressed button has not been pressed within 30 seconds. HEARTSTART FRx 861304 OWNER’S MANUAL recommended action • Stop CPR; do not touch the patient. Minimize patient motion. If the patient is being transported, stop the vehicle.

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    If it fails again, do not use the defibrillator. If it passes, store the defibrillator within the recommended temperature range. • Contact Philips for service if needed. • Remove the battery for five seconds then reinstall it to start the battery insertion self-test.

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    Group 1 CISPR 11 Class B HEARTSTART FRx 861304 OWNER’S MANUAL electromagnetic environment – guidance The FRx uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

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    Generally, AEDs are sometimes susceptible to interference generated by patient and/or responder motion in environments in which a high static electric field is present (e.g., low humidity, synthetic carpets, etc.). As a safety measure, Philips AEDs incorporate a patented method to sense possible corruption of the ECG signal by such interference and to respond by directing the user to stop all motion.

  • Page 60

    NOTE 5. Transmitters/antenna of this power-level are most likely mounted on an emergency vehicle chassis. The distances cited here are for open field. For an external antenna, the separation distance is most likely shorter. HEARTSTART FRx 861304 OWNER’S MANUAL separation distance according to frequency of transmitter (m) 80 MHz to 800 MHz d = 0.6√...

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    Shock cycle timing The FRx’s Quick Shock feature allows it to deliver a shock within 8 seconds, typical, following a CPR pause. From shock to shock, the FRx takes <20 seconds, typical, including analysis. After 15 shocks, the FRx takes <30 seconds from analyzing to ready-to-shock.

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    Notes HEARTSTART FRx 861304 OWNER’S MANUAL...

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    P O W E R S A V E Philips Medical Systems is part of Royal Philips Electronics REF: 989803138731 L I F E Philips Medical Systems United States Philips Medical Systems 2301 Fifth Avenue, Suite 200 Seattle, WA, USA 98121...

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