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T E C H N I C A L R E F E R E N C E M A N U A L

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   Summary of Contents for Philips HeartStart FRx

  • Page 1 Hear tS ta rt FR x D e fi br il la t or T E C H N I C A L R E F E R E N C E M A N U A L...
  • Page 2 US6356785, US6441582, US6553257, US6556864, Notices US6662056, US6871093, US7016726, US7463922, US7715913, US7822488, US8209008, US8335562, © 2014 Koninklijke Philips N.V. All rights reserved. USRE43050 and other patents pending. Specifications are subject to change without notice. Trademarks are the property of Koninklijke Philips N.V.
  • Page 3: Table Of Contents

    CONTENTS 1 THE HEARTSTART FRX DEFIBRILLATOR Sudden cardiac arrest and the AED ............Design philosophy for the FRx Defibrillator ..........Design features of the FRx AED ..............Reliability and Safety ................Ease of Use ....................No Maintenance ..................2 DEFIBRILLATION AND ELECTRICITY The Heart’s Electrical System ...............
  • Page 4 CONTENTS Arrhythmia Detection ..................Rate ......................Conduction ....................Stability ....................... Amplitude ....................Specific Analysis Examples ..............Sensitivity and Specificity ................ 4-10 Shockable Rhythms ..................4-11 Validation of Algorithm .................. 4-14 Specific Concerns for Advanced Users of HeartStart AEDs ....4-15 HeartStart AED vs.
  • Page 5 CONTENTS 6 THEORY OF OPERATION Overview ......................User interface ....................Operation ....................Maintenance ....................Troubleshooting ..................Control Board ....................Battery ......................Power Supply .................... ECG Front End ..................Patient Circuit ................... Data Recording ..................Temperature Sensor ................Timer ......................IR Port ......................7 DATA MANAGEMENT AND DEVICE CONFIGURATION Overview ......................
  • Page 6 Electromagnetic Conformity ................ Accessories Specifications ................Environmental considerations ..............A-11 B Troubleshooting Information Routine Troubleshooting for the Heartstart FRx Defibrillator ... Troubleshooting Steps ................... Verification of Energy Delivery ..............C Pads and Battery Defibrillator Pads for the FRx AED ............
  • Page 7: The Heartstart Frx Defibrillator

    DESIGN PHILOSOPHY FOR THE FRX DEFIBRILLATOR The Philips HeartStart FRx automated external defibrillator (AED) is designed specifically for use by the first people responding to an emergency. It is reliable, easy to use, and virtually maintenance free. The design allows this AED to be used by people with no medical training in places where American Heart Association.
  • Page 8: Design Features Of The Frx Aed

    The battery pack meets the U.S. Environmental Protection Agency's Toxicity Characteristic Leaching Procedure. All battery cells contain chemicals and should be recycled at an appropriate recycling facility in accordance with local regulations. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 9: Ease Of Use

    FRx, the CPR Coaching provided will be for infant/child CPR. PRE-CONNECTED PADS — The FRx uses a pair of HeartStart SMART • Pads II, supplied on a common liner in a disposable plastic case. The pads HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 10 The polarity of the pads does not affect the operation of the AED, but user testing has shown that people apply the pads more quickly and accurately if a specific position is shown on each pad. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 11: No Maintenance

    A solid Ready light means the defibrillator is being used • BATTERY LEVEL INDICATOR — The FRx AED prompts the user with an audible alarm when the battery or pads need to be replaced. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 12: Defibrillation And Electricity

    The left atrium collects the blood coming back from the lungs and pumps it into the left ventricle. Finally, the left ventricle pumps the oxygenated blood to the body, and the cycle starts over again. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 13 Although sudden death is possible, it does not always occur. Many times, a heart attack will lead to SCA, which does lead to sudden death if no action is taken. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 14 A person will sometimes “jump” when a shock is delivered, because the same current that causes all the working cells in the heart to contract can also cause the muscles in the chest to contract. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 15: Simplifying Electricity

    Voltage is measured in volts, current is measured in amperes (amps), and impedance is measured in ohms. Large amounts of electrical energy are measured in kilowatt-hours, as seen on your electric bill. Small amounts can be measured in joules (J), which are watt-seconds. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 16 SMART Biphasic waveform Although the relationship of voltage and energy is of interest in designing the defibrillator, it is actually the current that is responsible for defibrillating the heart. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 17 Biphasic waveform delivers the same amount of energy (150 J) to every patient, but the shape of the waveform changes to provide the highest level of effectiveness for defibrillating the patient at each impedance value. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 18 HeartStart Defibrillator is more effective in defibrillating out-of-hospital cardiac arrest patients than the waveforms used by conventional defibrillators. Moreover, the lower energy delivered results in less post-shock dysfunction of the heart, resulting in better outcomes for survivors. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 19: Smart Biphasic Waveform

    Historically, defibrillators used one of two types of monophasic waveforms: monophasic damped sine (MDS) or monophasic truncated exponential (MTE). With monophasic waveforms, the heart receives a single burst of electrical current that travels from one pad or paddle to the other. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 20 20th century, the waveform technology used for external defibrillation remained the same until just recently. In 1992, research scientists and engineers at Heartstream (now part of Philips Medical Systems) began work on what was to become a significant advancement in external defibrillation waveform technology.
  • Page 21 3. Lower energy is better for the patient because it reduces post-shock dysfunction. While this is not a new idea, it has become increasingly clear as more studies have been published. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 22: Smart Biphasic

    20 milliseconds. The distribution of the energy between the positive and negative pulses was fine tuned in animal studies to optimize defibrillation efficacy and validated in studies conducted in and out of the hospital environment. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 23: Understanding Fixed Energy

    This means that if the energy (current) level is chosen appropriately, escalating energy is not required to increase the efficacy. This HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 24: Evidence-based Support For The Smart Biphasic Waveform

    SMART Biphasic waveform. Thirteen of these are out-of-hospital studies that demonstrated high efficacy of the SMART Biphasic waveform on long-down-time patients in emergency environments. No other waveform is supported by this level of research. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 25: Key Studies

    (3 - 60 seconds) SMART Biphasic patients had lower rates of VF. Refibrillation rates were independent of waveform. 1999 low-energy (150 J) vs. 20 swine. Low-energy biphasic shocks increased likelihood of high-energy (200 J) successful defibrillation and minimized post-shock myocardial biphasic dysfunction after prolonged arrest. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 26: Frequently Asked Questions

    SMART Biphasic waveform, but more shocks were required at 200 J than at 150 J ). Conversely, a biphasic waveform designed for high-energy defibrillation may not defibrillate effectively at lower energies. (The Tang AHA abstract from 1999 showed poor resuscitation performance for the HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 27: How Can The Smart Biphasic Waveform Be More Effective At Lower Energy

    E = ½ C V The voltage (V) and the current (I) involved with defibrillating a patient are related to the patient impedance (R) by the equation: V = I R Peak Current Levels HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 28: Is Escalating Energy Required

    VF than either MDS or MTE monophasic waveform shocks ” (page S708). The Guidelines also state that “the optimal energy for first-shock biphasic waveform defibrillation has not been determined,” noting that “multiple HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL 3-10...
  • Page 29 150 J non-escalating SMART biphasic shock that was used. Of the patients for whom both weight and height data were available, HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL 3-11...
  • Page 30 However, common sense would suggest that if a given biphasic waveform needs more energy when pads are located properly, why would it perform HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL 3-12...
  • Page 31: Is There A Relationship Between Waveform, Energy Level, And Post-shock Dysfunction

    “Dysfunction” is reflected in reduced cardiac output as a result of reversible myocardial stunning. Dysfunction can result in significantly reduced cardiac output for many hours post-resuscitation. Waveforms that do not cause damage can cause dysfunction. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL 3-13...
  • Page 32: How Does Smart Biphasic Compare To Other Biphasic Waveforms

    J-360 J reveals that the evidence supporting this reputed 'gold standard' is largely speculative and is based largely on common sense extrapolation… Multiple high energy shocks could easily result in more harm than good.“ HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL 3-14...
  • Page 33: Commitment To Smart Biphasic

    Published clinical evidence also indicates that there is increased 7,8,27,28,31 dysfunction associated with high-energy shocks. Since the SMART Biphasic waveform has been proven effective for defibrillation at 150 J, there is no need to deliver more energy. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL 3-15...
  • Page 34: References

    Tang W, et al, Low capacitance biphasic waveform shocks improve immediate resuscitation after prolonged cardiac arrest. Circulation (supplement)1999:100(18):I-663 (abstract). Higgins SL, et al. A Comparison of Biphasic and Monophasic Shocks for External Defibrillation. PreHospital Emergency Care 2000; 4:305-313. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL 3-16...
  • Page 35 Resuscitation 2005 Jan; 64(1):63-69. American Heart Association. 2010 Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science. Circulation 2010;122[suppl 3]. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL 3-17...
  • Page 36: Smart Analysis

    Artifact can be caused in a variety of ways, including CPR, agonal breathing, transportation, patient handling, and the presence of a pacemaker in the patient. The action taken depends on how the artifact looks in relation to the ECG signal. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 37: Cpr At High Rates Of Compression

    Pacemaker artifact is removed from the signal for rhythm analysis. The two strips in the following figure represent the ECG before and after the pacemaker artifact is filtered out. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 38 ECG and look for changes in the rhythm, the unit quickly disarmed automatically in this situation when CPR was discontinued and no shock was delivered to the patient. Asystole is not considered a shockable rhythm. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 39: Arrhythmia Detection

    ECG in 4.0-second segments. The four parameters are the amplitude, rate, conduction (shape of the QRS complex), and stability of the rhythm (repeatability of the waveform pattern). A brief discussion of each of these parameters follows. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 40: Rate

    ECG by narrow QRS complexes with sharp transitions. Non-perfusing rhythms are characterized by wide complexes with smooth transitions. Therefore, a rhythm with wide complexes and smooth transitions is more likely to be shocked. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 41: Stability

    With a perfusing rhythm, the sequential complexes tend to be very similar in shape. An unhealthy heart will have chaotic, unstable complexes. Stability parameter HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 42: Amplitude

    In the graph below, the shock criteria plane is drawn in grey; any dot above the plane represents a shockable rhythm according to the algorithm, and any dot below is considered a non-shockable HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 43 Rate = 76 bpm Rate = 76 bpm Normal Sinus Rhythm: No-shock advised - excellent stability, conduction, and rate Rate = 218 bpm Rate = 218 bpm SVT: No-shock advised - excellent stability and conduction, high rate HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 44 Rate = 240 bpm Polymorphic VT: Shock advised - poor stability, very poor conduction, high rate Rate = 240 bpm Rate = 240 bpm Ventricular fibrillation: Shock advised - very poor stability and conduction, high rate HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 45: Sensitivity And Specificity

    Plot of evaluated ECGs shock/no shock decisions against the SMART Analysis parameters Automatic external defibrillators for public access defibrillation: recommendations for specifying and reporting arrhythmia analysis algorithm performance, incorporating new waveforms, and enhancing safety. Circulation. 1997;95:1677-1682. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL 4-10...
  • Page 46: Shockable Rhythms

    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. Circulation 1997;95:1677-1682. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL 4-11...
  • Page 47 American Heart Association Task Force on Automatic External Defibrillation, Subcommittee on AED Safety and Efficacy. Circulation. 95(6):1677-1682, March 18, 1997. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL 4-12...
  • Page 48 CPR before a shock is attempted. CPR tends to oxygenate the myocardium and increase the electrical activity of the heart, making it more susceptible to defibrillation. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL 4-13...
  • Page 49: Validation Of Algorithm

    Automatic External Defibrillators for Public Access Use: Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance, Incorporation of New Waveforms, and Enhancing Safety. Circulation 1997;95:1677-1682. c. From Philips Medical Heartstream ECG rhythm databases. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL 4-14...
  • Page 50: Specific Concerns For Advanced Users Of Heartstart Aeds

    Journal of Cardiovascular Electrophysiology, December 1997. Cecchin F, et al. Is arrhythmia detection by automatic external defibrillator accurate for children? Circulation, 2001; 103:2483-2488. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL 4-15...
  • Page 51: Use Of External Pacemakers With Internal Leads

    AED is applied to the patient. Failure to do so may result in delayed or incorrect analysis by the AED. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL 4-16...
  • Page 52: Other Features

    It is recommended that the full BIT be run only under the following conditions: • When the HeartStart FRx is first put into service and following each emergency use. • Whenever the battery is replaced (except when the FRx is in use on a patient).
  • Page 53: Periodic Self-tests

    The defibrillator will provide voice prompts that identify the problem and provide troubleshooting instructions. If at any time during the life of the device, your HeartStart FRx AED emitted or begins to emit a pattern of triple chirps, it is important that you remove the device from use, and contact your local Philips representative.
  • Page 54 OTHER FEATURES A blinking green Ready light means that the HeartStart FRx AED has passed a self-test within the last 24 hours and is therefore ready for use. If a written record of the periodic check is required, the visual check can be noted in an operator's checklist.
  • Page 55 BITs or DPSTs are being performed. Therefore, these tests are performed in addition to any periodic self-test. For example, the battery capacity will be tested by the RTST while the DPST is being performed. The continuous RTST includes checks of: HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 56: Cumulative Device Record

    In the troubleshooting process, Philips will occasionally ask a customer to download the information to Event Review (version 3.5 or higher) and transmit it to Philips to be analyzed by Philips personnel. SUPPLEMENTAL MAINTENANCE INFORMATION FOR...
  • Page 57: Calibration Requirements And Intervals

    FRx and render it unusable. SERVICE/MAINTENANCE AND REPAIR MANUAL The FRx AED has no user serviceable parts, and Philips is the sole repair facility for the unit. As a result, Philips does not publish Service/Maintenance and Repair Manuals for this product. Customer Service contact: 800-263-3342, 206-664-7745.
  • Page 58: Quick Shock

    OTHER FEATURES QUICK SHOCK The HeartStart FRx is able to deliver a shock in less than 8 seconds, typical, following a patient care pause. It is now well known that for longer down time patients, e.g., longer than 5 minutes, good CPR prior to defibrillation shock can help restore a normal heartbeat in more patients.
  • Page 59: Frx Trainer

    Internal Manikin Adapter M5088A, available separately from Philips. The HeartStart FRx Trainer and Training Pads II can also be used with an Infant/Child Pads Placement Guide and an Infant/Child Key, available separately from Philips, for training in pediatric defibrillation.
  • Page 60 • Trainer detects a shockable rhythm, instructs user to deliver a shock. • Trainer detects a non-shockable rhythm. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 61 Details: • Trainer detects a shockable rhythm, instructs user to deliver a shock. • Trainer still detects a shockable rhythm, instructs user to deliver another shock. • Trainer detects a non-shockable rhythm. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL 5-10...
  • Page 62 • After one pad is removed and reapplied, Trainer detects a shockable rhythm, instructs user to deliver a shock. • Trainer still detects a shockable rhythm, instructs user to deliver another shock. • Trainer detects a non-shockable rhythm. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL 5-11...
  • Page 63: Theory Of Operation

    Provide CPR Coaching, if so configured. • Repeat this process if necessary. Because the HeartStart FRx AED is designed to permit use by rescuers who are not trained to read ECGs and to distinguish between shockable and non-shockable rhythms, the device must also: •...
  • Page 64 The block diagram shown below indicates the major components of the HeartStart FRx AED. These include: • User interface • Control Board • Battery • Power supply • ECG Front End • Patient Circuit (high-voltage charger, high-voltage capacitor, switching/isolation circuitry) HeartStart FRx block diagram HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 65: User Interface

    When the user presses the i-button, the FRx will provide a voice instruction regarding the problem. MAINTENANCE Maintenance for the HeartStart FRx Defibrillator primarily consists of the user checking the regularly to verify that the unit is working and Ready light ready to be used.
  • Page 66: Control Board

    BATTERY The power source for the HeartStart FRx is a 9 VDC, 4.2 Ah battery pack. It contains 9 LiMnO battery cells, similar to those used in cameras. The battery pack is non-rechargeable.
  • Page 67: Data Recording

    Event Review documentation. TEMPERATURE SENSOR The HeartStart FRx incorporates a temperature sensor that allows the control board to determine the ambient temperature of the device. This enables the FRx to determine if it is exposed to temperatures outside the...
  • Page 68: Timer

    TIMER The HeartStart FRx records the elapsed time from the last event. If you leave the battery in the defibrillator 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 by subtracting the elapsed time from the computer’s clock.
  • Page 69: Data Management And Device Configuration

    ECG case data, including shocks and, for certain models, audio, recorded by your Philips or Laerdal AED. It allows you to add case details by adding notes and completing basic data entry screens. Using Event Review, you can integrate ECGs from multiple defibrillators into one case for a complete event history.
  • Page 70 Review Express. Event Review was tested with IR adapters from ACTISYS. An approved ACTISYS adapter is available from Philips Medical Systems. Detailed information about the Event Review suite of data management software programs is available online at www.philips.com/eventreview.
  • Page 71: System Requirements

    Windows XP or Microsoft Windows 7™ operating system. Make sure that any hardware you choose is certified as Microsoft-compatible. Philips provides only the Event Review software. The software and hardware listed in the following table are provided by the customer, unless noted. The...
  • Page 72: Comparison Of Event Review And Event Review Pro

    Shared Database Vital Trends Import Service Research Mode Yes (Not Available Commercially) EMS Notes Subset Yes (EMS Edition) Hospital Notes Yes (Hospital Edition) System Response Reports Yes (EMS Edition) Utstein Reports Yes (EMS Edition) HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 73: System Annotations

    (e.g., “press pads firmly”) to alert the user that the defibrillation pads are not making good contact. PADS OFF — The measured impedance has become too high and indicates that the defibrillation pads are no longer connected between the defibrillator and the patient's chest. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 74: Technical Support For Data Management Software

    SOFTWARE Telephone support for the HeartStart Event Review software suite in North America is provided by the Philips Customer Care Solutions Center in Alpharetta, Georgia, USA. For telephone assistance outside the United States, the please call your local sales representative or Local Response Center.
  • Page 75: Configuration Software

    Philips Healthcare data management support at www.philips.com/DataManagementSupport. CONFIGURATION SOFTWARE The 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 special HeartStart software available from Philips. The setup of the FRx can be modified using HeartStart Configure version 1.0 or higher.
  • Page 76: A Technical Specifications

    (models 861304 and 861305). These products are classified as Class IIb, Rule 9 of Annex IX of the MDD. All these devices meet the provisions of the council Directive 93/42/EEC for Medical Devices. All supporting documentation is retained under the premises of the manufacturer, Philips Medical Systems, Heartstream. STANDARDS APPLIED •...
  • Page 77: Frx Aed Specifications

    Standby: meets MILSTD 810F Fig. 514.5C-18, swept sine (helicopter). sealing Meets IEC 529 class IPx5 for jetting water and class IP5x for solid objects (dust protected). aircraft: method Meets RTCA/DO-160D:1997 Section 21 (Category M - Charging). HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 78: Controls And Indicators

    Provides chirps when troubleshooting is needed. status indicator Status indicator LCD displays device readiness for use. low battery Automatic during daily periodic self-testing. detection low battery Alarm chirps and flashing blue in-button. indicator HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 79 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 80 (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, •...
  • Page 81: Electromagnetic 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 82 If the measured field strength in the location in which the HeartStart FRx is used exceeds the applicable RF compliance level above, the HeartStart FRx should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the HeartStart.
  • Page 83 TECHNICAL SPECIFICATIONS PORTABLE AND MOBILE RF EQUIPMENT 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 84: Accessories Specifications

    TSO standards. TSO articles must have a separate approval for installation in an aircraft. The article may be installed only if performed under 14 CFR Part 43 or the applicable airworthiness requirements. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 85 Pads package is labeled with a use-by date of at least two years from date of manufacture. INFANT/CHILD KEY 989803139311 CATEGORY SPECIFICATIONS size 6.3” x 2.4” x 0.2” (16 cm x 6 cm x 0.5 cm). weight 1.0 oz (29 g). material Polycarbonate. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL A-10...
  • Page 86: Environmental Considerations

    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 DEFIBRILLATOR TECHNICAL REFERENCE MANUAL A-11...
  • Page 87: B Troubleshooting Information

    FRx passes the self-test, you can be assured it is ready for use. Troubleshooting a Chirping HeartStart Your Philips AED tests itself at regular intervals to ensure it is ready for use. If your AED emits a pattern of single chirps ( ), please press the flashing blue i-button for information.
  • Page 88 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 89: Troubleshooting Steps

    If the test fails, press the blue i-button and follow the voice instructions as noted above. If the defibrillator continues to instruct you to remove and reinsert the battery, do not use the defibrillator. Contact Philips Medical Systems for technical support.
  • Page 90 4. Wait for the AED to recommend a shock and when prompted, press the orange button. 5. Verify that the Impulse 4000 indicates 130-170 Joules. 6. Press the AED On/Off button and disconnect adapter cable. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 91 AED may occur and will invalidate product warranty. • For questions or additional support regarding Philips AEDs, please contact your local technical support team, visit www.philips.com/AEDsupport, or email AEDSupport@philips.com. If you are a customer living in North America, please call 1-800-263-3342 for technical support.
  • Page 92: Cpads And Battery

    50 joules and, if optional CPR Coaching is selected, provides coaching appropriate for infants < 55 LBS / 25 KG and children. See Chapter 5 for a discussion of Infant/Child Key pediatric defibrillation with the FRx AED. accessory. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 93: Defibrillator Pads Placement With The Frx Aed

    AED’s algorithm or the efficacy of the delivered energy in any way. The HeartStart FRx is intended for use by people with minimal training and are therefore designed to be as easy to use as possible. Labeling the pads with specific locations was just one of many design decisions made to reduce the variables present in using the device.
  • Page 94: Batteries For The Frx Aed

    These batteries are designed specifically for high-volume consumer applications, where safety is of the utmost importance. The batteries chosen for HeartStart AEDs meet Philips's high standard of quality and have been proven to be reliable and safe over many years of operation.
  • Page 95 U.S. EPA's Toxicity Characteristic Leaching Procedure and therefore may be disposed of with normal waste without a complicated recycling process. However, out of environmental considerations, Philips recommends that all batteries be recycled at an appropriate recycling center. Battery Usage...
  • Page 96 BIT. If the unit again does not pass, contact Philips Customer Service. In the United States, contact Philips Medical Systems at 1-800-263-3342 for assistance.
  • Page 97: D Use Environment

    Some of this current will pass over the surface of the patient's skin, and if the patient is resting on an electrically insulating surface, all defibrillation energy is kept within the HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 98 American Heart Association (Guidelines 2000), metal surfaces “pose no shock hazard to either the victim or rescuer.” Testing To confirm there would be no effect on the user, Philips has simulated a 150J SMART Biphasic shock to a patient on a wet concrete surface using chlorinated pool water.
  • Page 99 Bystander risk in an actual defibrillation event is likely to be considerably less than the simulated bystander risk, because patient head and limbs will provide greater separation between the bystander and the defibrillation pad area. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 100: Protection Against Water And Particles

    2.5 mm diameter and greater Protected against hazardous Protected against solid foreign parts with a 1mm diameter objects of 1.0 mm and greater wire Protected against hazardous Dust protected parts with a 1mm diameter wire HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 101 Not tested Heartstart Defibrillator Testing Each level of protection requires that the product pass a predefined test. The HeartStart FRx meets the specifications for IP55. The tests performed by Philips to meet this standard are outlined below. IP5X Testing A 1.0 mm wire was pushed into all openings of the defibrillator with a force of 1 N without pressing through the openings.
  • Page 102: Effects Of Extreme Environments

    3 minutes. The defibrillator was then removed, inspected, and tested to ensure that the water had not accumulated enough to affect the performance or safety of the defibrillator. EFFECTS OF EXTREME ENVIRONMENTS The HeartStart FRx AED has a recommended environmental range of: environment range operating temperature 32°...
  • Page 103: Self-test Aborts Due To Temperature Extremes

    If the defibrillator aborts the self-test three times in a row (over a 16 hour period) it will issue a warning that the unit is being stored incorrectly and is not capable of accurately performing its self-tests, and may not be ready for service. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 104 To prevent this issue from occurring again, the defibrillator should be stored within the specified standby temperatures — 32°-122° F (0°- 50° C) — as noted in the Owner’s Manual. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 105: E Guidelines 2005/2010

    Guidelines 2005, Philips confirmed that the Guidelines 2005-optimized HeartStart devices also satisfy Guidelines 2010. Throughout the world, with two exceptions, all Philips AEDs carrying a “2005 GUIDELINES” label on the rear of the device fulfill the Guidelines 2010. The exceptions are Japan and Sweden. In these nations, national resuscitation committees produced country-specific guidelines derived from the Guidelines 2010.
  • Page 106 30:2 compressions-to-ventilation ratio. To configure your HeartStart FRx to conform to your Medical Director’s emergency response workflow without sending the device, back to the factory, see the instructions below.
  • Page 107 This will allow you to send and receive information between the defibrillator and the computer running one of the applications in the HeartStart configuration and data management software suite. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 108 5. In the “Welcome to the Configuration Transfer Wizard” window, click Next. On the “Select Defibrillator” page, click on the row with HeartStart FRx in the list, and then click Next. The selected AED is identified by a Serial Number as well as the interface type (infrared).
  • Page 109 8. In the “Welcome to the Configuration Transfer Wizard” window, click Next. On the “Select Defibrillator” page, click on the row with HeartStart FRx in the list, and then click Next. The selected AED is identified by a Serial Number as well as the interface type (infrared).
  • Page 110 Ensure that the correct current AED configuration (Guidelines 2000 or 2005/2010) has been selected. • Make sure that the defibrillator is in administration mode, and that it has not timed out and returned to standby mode. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 111 If required, have your IT help desk update your computer’s operating system accordingly. For questions or additional support regarding Philips AEDs, please contact your local technical support team, visit www.philips.com/AEDsupport, or email AEDSupport@philips.com. If you are a customer living in North America, please call 1-800-263-3342 for technical support.
  • Page 112: Literature Summary For Heartstart Aeds

    There is also a citation of the actual source or abstract for additional details. The Philips HeartStart SMART Biphasic waveform is set apart from other waveforms by the sheer volume of research data available to support it.
  • Page 113: References

    50-J shocks successfully resuscitated animals resuscitation. Crit Care Med 2002 Dec; 30(12):2736-41. ranging from 3.7 to 25 kg without compromise of postresuscitation myocardial function or survival.” HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 114 Moreover, the current flow analysis revealed many complex and unexpected current flow patterns that have never been observed before. This study has, for the first time, noninvasively measured the volume current measurement inside the pig torso.” HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 115 These observations argue for a damage mechanism related to cumulative, rather than instantaneous, electrical exposure.” See Selected Clinical Studies at the end of this chapter for a more detailed discussion of this publication. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 116 AEDs appropriate for an expanded group of out-of-hospital first responders and, eventually, layperson use.” NOTE: This study of a 115J and 130J waveform contributed to the development of the 150 J, nominal, therapy that ships with Philips AEDs. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 117 Gliner BE, White RD. Electrocardiographic evaluation “At each analysis time, there were more patients in VF of defibrillation shocks delivered to out-of-hospital following high-energy monophasic shocks than sudden cardiac arrest patients. Resuscitation 1999 following low-energy biphasic shocks.” Jul;41(2):133-44. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 118 2004 Sep; 32(9 Suppl):S436-9. not adversely affect survival. Thus, vigilance for recurrent VF is essential to ensure the survival of patients who are in the care of first responders, even after initial restoration of pulses with shocks.” HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 119 VF arrest are safe, american heart association committee on emergency acceptable, and clinically effective.“ cardiovascular care and the subcommittees on basic life support, advanced cardiac life support, and pediatric resuscitation. Circulation 1998; 97:1654-1667. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 120 Working personnel and emergency medical services staff should be informed about potential risks and the possible need for patient evacuation before AEDs are attached and shock recommendations are followed.” HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL...
  • Page 121 Defibrillator design should minimize this interval to avoid potential adverse consequences on patient survival. See Selected Clinical Studies at the end of this chapter for a more detailed discussion of this publication. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL F-10...
  • Page 122 The difference between the groups is external defibrillator. Circulation 1999; 100:1703-1707. surprisingly small, considering the naivete of the children as untutored first-time users.” HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL F-11...
  • Page 123 Prehospital Emergency Care 2004; 8:284-291. deliver a shock. Avoiding grossly inappropriate pad placement and failure to place AED pads directly on skin may be correctable with improvements in the AED instruction user interface.” HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL F-12...
  • Page 124 The correct placement of the electrodes needs be emphasized more in the resuscitation training.” HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL F-13...
  • Page 125 Callejas S, Barry A, Demertsidis E, Jorgenson D, “Both devices [Philips FR2 or HS1] are safe with either Becker LB. Human factors impact successful lay person video-trained or naive users. The successful use of each...
  • Page 126 CA [cardiac arrest] victims.“ volunteers and laypersons for out-of-hospital cardiac arrest: the Brescia Early Defibrillation Study (BEDS). Eur Heart J 2006 Mar; 27(5):553-61. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL F-15...
  • Page 127: Selected Study Summaries

    Introduction This study, supported in part by grants from NIH National Heart, Blood and Lung Institute, the American Heart Association, and Philips Medical Systems, examined the effects of biphasic truncated exponential waveform design on survival and post-resuscitation myocardial function after prolonged ventricular fibrillation (VF).
  • Page 128 These findings suggest that peak current is a more appropriate measure of defibrillation dose than either energy or average current. Furthermore, these conclusions suggest that post-resuscitation myocardial dysfunction is related to a cumulative, as opposed to an instantaneous, electrical exposure mechanism. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL F-17...
  • Page 129: Heartstart Quick Shock Feature

    Circulation. 2006 June 13; 113(23)2683-9. Introduction This study, funded by Philips Medical Systems and the American Heart Association, was undertaken in response to suggestions by previous clinical studies that AED-imposed interruptions of cardiopulmonary resuscitation (CPR) occurring after initial defibrillation shocks may adversely affect patient outcomes.
  • Page 130 This results in a reduction of coronary perfusion pressure and myocardial blood flow and decreases the likelihood of successful resuscitation. In addition, fewer chest compressions increases the severity of HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL F-19...
  • Page 131 72-hour survival after prolonged VF. Adoption of a one-shock protocol, however, improved initial resuscitation and survival. Post-resuscitation myocardial dysfunction was less pronounced with the low-energy waveform, independent of shock protocol. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL F-20...
  • Page 132: Heartstart's Human Factors Design

    The “victim” was a dressed manikin, and volunteers were provided with the AED trainer, a face shield, and latex gloves. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL F-21...
  • Page 133 Massachusetts USA); bottom row, left to right: Access™ (Access Cardio Systems, Concord, Massachusetts, USA), Power Heart Training Unit™ (Cardiac Science Inc., Irvine, California, USA), and HS1™(Philips Medical System, Andover, Seattle, USA). The volunteers were then evaluated to see when they delivered the first shock (measured in seconds) and whether they started BLS after the first shock.
  • Page 134 Conclusions This study demonstrated that there are significant differences between AED human factor design solutions that affect important operational outcomes like time to first shock and the start of BLS. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL F-23...
  • Page 135: Heartstart Defibrillation Therapy Testing In Adult Victims Of Out-of-hospital Cardiac Arrest

    115 patients were similar in terms of age, sex, weight, primary structural heart disease, cause and location of arrest, and bystanders witnessing the arrest or performing CPR. The average time from call to first ± shock was 8.9 3 minutes. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL F-24...
  • Page 136 (ROSC) (p=0.01). EMS system outcomes of survival discharge were not significantly different statistically. However, patients resuscitated with the lower-energy SMART Biphasic waveform were more likely to have good cerebral performance (CPC, cerebral performance category) (p=0.04). HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL F-25...
  • Page 137: Heartstart Patient Analysis System Testing With Pediatric Rhythms

    >1 <8 years 3 yrs 15.5 kg 20/20 (40) (1.1-7 yrs) (7.6-38.0 kg) >8 <12 years 9 yrs 34.2 kg 21/14 (35) (8-12 yrs) (22.0-70.7 kg) Total (134) 1.8 yrs 10.0 kg 81/53 HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL F-26...
  • Page 138 116 (100%) >95% 98.0% 95 (100%) >95% 97.6% idio 40 (100%) >95% 94.4% asystole 39 (100%) >95% 94.3% Armitage P and Berry G, Statistical Methods in Medical Research, Blackwell Scientific Publications, 2 edition, 1987. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL F-27...
  • Page 139 This study indicates that the HeartStart Patient Analysis System can be used safely and effectively for both adults and children. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL F-28...
  • Page 140: Heartstart Defibrillation Therapy Testing In Apediatric Animal Model

    There was no difference in post-resuscitation myocardial function as measured by echocardiographic ejection fraction and fractional area change among the groups. Stroke HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL F-29...
  • Page 141 These studies demonstrated that fixed 50 J Heartstream biphasic waveform shocks successfully resuscitated pigs ranging from 3.5 to 25 kg regardless of weight. All animals survived and there was no evidence of compromised post-resuscitation systolic or diastolic myocardial function. HEARTSTART FRx DEFIBRILLATOR TECHNICAL REFERENCE MANUAL F-30...
  • Page 142 INTENTIONALLY BLANK...
  • Page 143 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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