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Philips HeartStart FRx Owner's Manual

Automated external defibrillator.
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Philips
HeartStart FRx
Manual
Get an original copy of the Philips HeartStart FRx Manual for
manufacturer information about service, available
accessories and how to use and maintain your device.

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Table of Contents

   Summary of Contents for Philips HeartStart FRx

  • Page 1 Philips HeartStart FRx Manual Get an original copy of the Philips HeartStart FRx Manual for manufacturer information about service, available accessories and how to use and maintain your device.
  • Page 2 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 13...
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  • Page 6 HeartStart FRx Defibrillator QUICK REFERENCE Check for signs of Sudden Cardiac Arrest: Unresponsive Not Breathing Normally TURN ON PLACE PRESS PADS SHOCK...
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  • Page 8 HeartStart FRx 861304 Automated External Defibrillator O W N E R ’ S M A N U A L Edition 13 IMPORTANT NOTE: It is important to understand that survival rates for sudden cardiac arrest are directly related to how soon victims receive treatment. For every minute of delay, the chance of survival declines by 7% to 10%.
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  • Page 10 If you need technical support, please contact your local physician. Philips representative by calling the regional number on the back cover of this manual, or go to www.philips.com/ The Philips HeartStart FRx is designed to be AEDsupport.
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  • Page 12: Table Of Contents

    CONTENTS 1 INTRODUCTION TO THE HEARTSTART FRX Description ......................1 Sudden cardiac arrest ..................1 Indications for use ....................1 Implementation considerations ............... 2 For more information ..................2 2 SETTING UP THE HEARTSTART FRX Package contents ....................3 Setting up the FRx ....................3 Recommended accessories ................
  • Page 13 APPENDICES A Accessories ....................23 B Glossary of terms ..................25 C Glossary of symbols/controls ..............29 D Warnings and Precautions ..............33 E Technical information ................35 Configuration ....................43 G Testing and troubleshooting ..............49 H Additional technical data required for European conformity ...55...
  • Page 14: Introduction To The Heartstart Frx

    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 15: Implementation Considerations

    (CPR). Several national and local organizations offer combined CPR/AED training. Philips recommends that you train on the device you will be using. Contact your Philips representative for information, or visit us online at www.philips.com/ AEDservices to learn about certified training and web-based refresher training (offered in select areas) available through Philips AED Services.
  • Page 16: Setting Up The Heartstart Frx

    † In Japan, the defibrillator comes with a different style of booklet and maintenance tag. ‡ If the battery and pads are not installed, follow the directions in Chapter 4, “After Using the HeartStart FRx” to install the pads and battery.
  • Page 17 FRx where it is hard to hear the voice instructions. Any of the carry case options has room for storing the Quick Reference Guide. ‡ See Chapter 4, “After Using the HeartStart FRx” for directions on how to replace the battery in the FRx.
  • Page 18 Use the maintenance tag provided to record EXPIRATION DATE the expiration date of 12/2010 the installed pads. If you have a spare pads case and spare battery, record the pads expiration date and battery install-by date INSTL. DATE on the maintenance INSTALL EXP.
  • Page 19: 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 information. 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 20: Using The Heartstart Frx

    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 21: Step 1: Press The Green On/off Button

    STEP 1: PRESS THE GREEN ON/OFF BUTTON Press the On/Off button turn on the FRx. The FRx tells you to remove all clothes from the person’s chest. If necessary, rip or cut off the clothing to bare the person’s chest. Press green On/Off button.
  • Page 22: 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 55 pounds children under 55 pounds (25 kg) or (25 kg) 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 FRx detects that the pads are attached to the patient, the pads icons turn off.
  • Page 23: Treating Infants And Children

    * The default configuration for the FRx provides CPR Coaching when you press 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.
  • Page 24 If the victim is under 55 pounds (25 kg) or 8 years old, and you have an Infant/ Child Key: • Insert the Infant/Child Key into the slot at the top center of the front panel of the FRx (see illustration at left). The pink portion of the Key pivots (1) and fits into the slot (2), with the front of the Key lying flat on the surface of the FRx so the infant/child pads placement diagram is visible.
  • Page 25: When Emergency Medical Services Arrive

    Each pad has a layer of adhesive gel. If the gel is not sticky to the touch, replace the pads with a new set. (For ease of handling, the pad is designed with a non-gel area around the connector cable.) * See Chapter 4, “After Using the HeartStart FRx,” for details about data storage.
  • Page 26 • Keep the patient still and keep any movement around the patient to a minimum during rhythm analysis. Do not touch the patient or the pads while the Caution light is on solid or flashing. If the FRx is unable to analyze due to electrical “noise”...
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  • Page 28: After Using The Heartstart Frx

    Check the outside of the FRx for signs of damage, dirt, or 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 HeartStart FRx.”...
  • Page 29: 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 at www.philips.com/eventreview.
  • Page 30 The information automatically stored by the FRx includes a summary of last-use data and detailed data about its last clinical use. You can get a voice summary of information about the last use of the defibrillator by holding the i-button down until it beeps once.
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  • Page 32: Maintaining The Heartstart 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. Record each periodic check in your inspection log/maintenance booklet.
  • Page 33: Cleaning The Frx

    CLEANING THE FRX The outside of the HeartStart FRx can be cleaned with a soft cloth dampened in soapy water, chlorine bleach (2 tablespoons per quart or liter of water), ammonia-based cleaners, or 70% isopropyl (rubbing) alcohol. It is recommended that the carry case be cleaned with a soft cloth dampened in soapy water.
  • Page 34: Troubleshooting A Chirping Heartstart

    If you ever hear your AED emit a series of triple chirps: • in stand-by mode — please call Philips immediately for technical support at the regional number listed on the back cover of this manual. •...
  • Page 35: Appendices

    APPENDICES A Accessories 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...
  • Page 36: Aaccessories

    ACCESSORIES Accessories for the HeartStart FRx Defibrillator 861304 available separately from your local Philips representative or online at www.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) •...
  • Page 37 HeartStart Event Review Pro, upgrade [REF: 861436] • Infrared adapter for use with HeartStart Event Review software [REF: ACT-IR] • HeartStart FRx Defibrillator Quick Reference Guide [REF: 989803138601] • Training • HeartStart Training Pads II (kit containing one set of Training Pads II in...
  • Page 38: Bglossary 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.
  • Page 39 If the HeartStart FRx detects artifact such as that created by CPR, or if the user presses the i-button for CPR Coaching during a SMART NSA pause, the defibrillator will not exit the pause for rhythm analysis in order to allow CPR to be completed uninterrupted.
  • Page 40 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. In addition, pressing the On/Off button stops the battery insertion self-test that automatically runs when a battery is inserted.
  • Page 41 The operating mode of the HeartStart FRx Defibrillator when a battery has been installed, and the unit is turned off and ready for use when needed. Shown by blinking green READY light.
  • Page 42: Cglossary 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.
  • Page 43 symbol description Do not mutilate the battery or open the battery case. Needs to be protected from moisture. Handle with care. This side up. Defibrillation protection. Defibrillation protected, type BF patient connection. Meets IEC 60529 class IPx5 for jetting water from any direction and class IP5x for protection against access to hazardous parts and ingress of solid foreign objects (dust protected).
  • Page 44 symbol description Environmental requirements. 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. 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).
  • Page 45 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 46: Dwarnings And Precautions

    WARNINGS AND PRECAUTIONS It is important to understand how to use your HeartStart FRx Defibrillator safely. Please read these warnings and precautions carefully. A warning describes something that could cause serious personal injury or death. A precaution describes something that could cause minor personal injury, damage to the FRx, loss of data stored in the FRx, or less chance of successful defibrillation.
  • Page 47 cell phones The FRx can work correctly when it is fairly close to equipment like emergency two-way radios and cell phones. Normally, using a cell phone near the patient should not cause a problem for the FRx. However, it is best to keep such equipment only as close as necessary to the patient and the FRx.
  • Page 48: Etechnical 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 Manuals for HeartStart Automated External Defibrillators, located online at www.philips.com/ productdocs. PHYSICAL category specifications size 2.4”...
  • Page 49 category specifications vibration Operating: meets MILSTD 810G Fig. 5146E-1, random. Standby: meets MILSTD 810G Fig. 5146E-2, swept sine (helicopter). sealing Meets IEC 60529 class IP55. Protected against jetting water from any direction per IEC 60529 class IPx5, and against access to hazardous parts and ingress of solid foreign objects (dust protected) per IEC 60529 class IP5x.
  • Page 50 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 FRx delivers shocks to load impedances from 25 to 180 ohms. The duration of each phase of the waveform is dynamically adjusted...
  • Page 51 (AED mode) Once charged, the HeartStart FRx will disarm if: • patient’s heart rhythm changes to non-shockable rhythm, • a shock is not delivered within 30 seconds after the FRx is armed, • the On/Off button is pressed for one second to turn off the FRx, •...
  • Page 52 Ventricular fibrillation (VF) and some ventricular tachycardias, including ventricular flutter and polymorphic ventricular tachycardia (VT). The HeartStart FRx Defibrillator uses multiple parameters to determine if a rhythm is shockable. NOTE: Some very low-amplitude or low-frequency rhythms may not be interpreted as shockable VF rhythms.
  • Page 53 From Philips Medical Systems 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 54 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 77° F (25° C). shelf life A minimum of 5 years from date of manufacture when stored and maintained (prior to insertion)
  • Page 55 Substances of Very High Concern (SVHC) if they are present above 0.1% of the article weight. The SVHC list is updated on a regular basis. Therefore, refer to the following Philips REACH website for the most up-to-date list of products containing SVHC above the threshold:...
  • Page 56: Fconfiguration

    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. This software is for use by trained personnel.
  • Page 57 PATIENT TREATMENT PROTOCOL OPTIONS parameter settings default default description “call EMS” voice • At power on (when the At the start of Provides a voice reminder to reminder timing user turns on the FRx) the first make sure emergency patient care medical services have been •...
  • Page 58 parameter settings default default description protocol pause timer 0.5, 1.0, 1.5, A 2-minute protocol pause (minutes) 2.0, 2.5, 3.0 for CPR automatically starts after voice instruction is given when a shock series is completed. After the protocol pause, the defibrillator returns to rhythm analysis.
  • Page 59 parameter settings default default description NSA pause timer 0.5, 1.0, 1.5, A 2-minute NSA pause for (minutes) 2.0, 2.5, 3.0 CPR automatically starts after voice instruction is given when no shock is advised (NSA).* If the user presses the i-button for optional CPR coaching, the FRx provides coaching for 5 cycles of CPR, starting and ending with...
  • Page 60 Intentionally blank. parameter settings default default description CPR Coaching yes, no Optional CPR Coaching infant/child ventilation includes rescue breaths at the instruction rate determined by the CPR Coaching compression: ventilation ratio for infants and children when an infant/ child pads set is installed. NOTE: If this parameter is configured to NO, CPR Coaching will always be...
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  • Page 62: Gtesting And Troubleshooting

    TESTING AND TROUBLESHOOTING TESTING 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 Manuals for HeartStart Automated External Defibrillators, located online at www.philips.com/productdocs, for a detailed discussion of the self-tests.
  • Page 63 RECOMMENDED ACTION WHEN YOU NEED TO USE THE DEVICE If the FRx is chirping and the i-button is flashing, it is possible that the defibrillator still has enough battery power to be used to treat a victim of SCA. Press the On/Off button. 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.
  • Page 64 defibrillator says: possible cause recommended action ... to press the pads firmly • The pads are not properly applied • Make sure that the pads are sticking to the skin to the patient. completely to the patient’s skin..to make sure the pads •...
  • Page 65 NOTE: In the event of a triple-chirp alert, even if the failure is cleared by a battery insertion test, please contact Philips for service. In the event of repeated instances of a self-test failure resulting in single-chirp alerts, even if such failures are cleared by a battery insertion test, please contact Philips for service. behavior...
  • Page 66 If it fails again, do no response to not use the defibrillator. pressing i-button • The defibrillator may have been • Contact Philips for service. physically damaged.
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  • Page 68: Hadditional Technical Data Required For European Conformity

    Guidance and manufacturer’s declaration: The HeartStart FRx is intended for use in the electromagnetic environment specified in the tables below. The customer or user of the HeartStart FRx should assure that it is used in such an environment. ELECTROMAGNETIC EMISSIONS...
  • Page 69 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 70 immunity test IEC 60601 compliance level electromagnetic environment – test level guidance d = 0.60 P radiated RF 10 V/m 20 V/m IEC 61000-4-3 80 MHz to 80 MHz to 800 MHz 2.5 GHz d = 1.2P 80 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the...
  • Page 71 AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE HEARTSTART FRX DEFIBRILLATOR The HeartStart FRx Defibrillator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the FRx can help prevent electromagnetic interference by...
  • Page 72 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.
  • Page 73 United States Philips Medical Systems 22100 Bothell Everett Highway Bothell, WA 98021-8431, USA (800) 263-3342 Canada Philips Healthcare, a Division of Philips Electronics Ltd. 281 Hillmount Road Markham, Ontario L6C 2S3, Canada (800) 291-6743 Europe, Middle East, and Africa Philips Medizin Systeme Boeblingen GmbH...

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