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laerdal HEARTSTART FRx Owner's Manual
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laerdal HEARTSTART FRx Owner's Manual

Defibrillator
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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
861305
Edition 8

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Summary of Contents for laerdal HEARTSTART FRx

  • Page 1 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 861305 Edition 8...
  • Page 3 HeartStart FRx Defibrillator QUICK REFERENCE...
  • Page 4 Intentionally blank.
  • Page 5 HeartStart FRx 861305 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%.
  • Page 6 FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE Edition 8 BY OR ON THE ORDER OF A PHYSICIAN. Publication date: April 2007 The HeartStart is designed to be used only with Laerdal- Publication #: 989803138861 approved accessories. The HeartStart may perform Assembly #: 012716-0008 improperly if non-approved accessories are used.
  • Page 7 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 ....................
  • Page 8 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 861305 OWNER’S MANUAL...
  • Page 9 Introduction to the HeartStart FRx Description The HeartStart FRx Defibrillator 861305 (“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 Several national and local organizations offer combined CPR/ defibrillator training. Contact your Laerdal Medical representative for information about training programs in your area. NOTE: Training accessories are available from Laerdal for practicing use of the FRx. See Appendix A for information on ordering accessories.
  • Page 11 For more information Contact your local Laerdal 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 Shock button. It will then say “On/Off button test” and instruct you to push the On/Off button. Push the buttons when * Unless otherwise noted, references to pads in this document are to HeartStart SMART Pads II. HEARTSTART FRx 861305 OWNER’S MANUAL...
  • Page 13 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 — to dry the victim's skin for good pads contact Laerdal 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 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 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 861305 OWNER’S MANUAL...
  • Page 17 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. The FRx begins analyzing the patient’s heart rhythm. It tells you...
  • Page 18 * 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. HEARTSTART FRx 861305 OWNER’S MANUAL...
  • Page 19 If the victim is under 55 pounds 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 20 Infant/Child Key, if used, and install a new pads set before returning the 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 861305 OWNER’S MANUAL...
  • Page 21 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 1. Check the outside of the FRx for signs of damage, dirt, or contamination. If you see signs of damage, contact Laerdal for technical support. If the defibrillator is dirty or contaminated, clean it according to the guidelines in Chapter 5, “Maintaining the HeartStart FRx.”...
  • Page 23 FRx data storage The FRx automatically stores data about its last clinical use in its internal memory. 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.
  • Page 24 This uses battery power and risks draining the battery prematurely. † If ECG recordings from a previous use have not been erased, the maximum time for new ECG recordings may be less. HEARTSTART FRx 861305 OWNER’S MANUAL...
  • Page 25 Philips for technical support. 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.
  • Page 26 Insert/replace battery and run the self-test. As long as the FRx passes the self-test, you can be assured it is ready for use. More detailed testing and troubleshooting information is available in Appendix G. HEARTSTART FRx 861305 OWNER’S MANUAL...
  • Page 27 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...
  • Page 28 Notes HEARTSTART FRx 861305 OWNER’S MANUAL...
  • Page 29 Accessories Accessories for the HeartStart FRx Defibrillator 861305 available separately from your local Laerdal representative include: • Battery [REF: M5070A] (spare is recommended) • HeartStart SMART Pads II [REF: 989803139261] (spare is recommended) • Carry Cases • FRx carry case [REF: 989803139251] •...
  • Page 30 • Adult pads placement guide [REF: M5090A] • Infant/Child pads placement guide [REF: 989803139281] • HeartStart FRx Defibrillator Instructor's Training Toolkit, NTSC [REF: 989803139321] or PAL [REF: 989803139331] • HeartStart FRx Defibrillator Training DVD [REF: 989803139341] • Internal Manikin Adapter [REF: M5088A] •...
  • Page 31 Glossary of terms The terms listed in this Glossary are defined in the context of the HeartStart FRx Defibrillator 861305 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 32 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 33 AED mode. protocol pause A period provided by the HeartStart FRx Defibrillator after a shock series, during which the responder can administer CPR. The defibrillator does not conduct background monitoring of the patient’s heart rhythm during this pause.
  • Page 34 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 35 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 36 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). Environmental (temperature and relative humidity) requirements. HEARTSTART FRx 861305 OWNER’S MANUAL...
  • Page 37 symbol description 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).
  • Page 38 Expiration date. Federal law (USA) restricts this device to sale by or on the order of a physician. 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.
  • Page 39 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 40 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 861305 OWNER’S MANUAL...
  • Page 41 Technical information HeartStart FRx 861305 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 6 cm H x 18 cm D x 22 cm W.
  • Page 42 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 861305 OWNER’S MANUAL...
  • Page 43 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 based on...
  • Page 44 (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 45 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 46 M5071A no; use M5072A competitive adapters manual mode only * Pre-connectable to FRx defibrillator only. pads shelf life Pads package is labeled with a use-by date of at least two years from date of manufacture. HEARTSTART FRx 861305 OWNER’S MANUAL...
  • Page 47 M5070A 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. (IEC 60601-2-4, 2002) shelf life A minimum of 5 years from date of manufacture when stored and maintained (prior to insertion) according to directions provided in this document.
  • Page 48 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 861305 OWNER’S MANUAL...
  • Page 49 Configuration Overview 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 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 50 * 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 861305 OWNER’S MANUAL...
  • Page 51 parameter settings default default description protocol pause timer 0.5, 1.0, 1.5, A 2-minute protocol pause for (minutes) 2.0, 2.5, 3.0 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 52 * 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 861305 OWNER’S MANUAL...
  • Page 53 parameter settings default default description CPR Coaching yes, no Optional CPR Coaching adult ventilation instruction includes rescue breaths at the rate determined by the CPR Coaching compression: ventilation ratio for adults when an adult pads set is installed. Note: if this parameter is configured to NO, CPR Coaching will always be compressions-only when an adult pads set is...
  • Page 54 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 Guide, available online at www.medical.philips.com/heartstart, for a detailed discussion of the self-tests.
  • Page 55 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.
  • Page 56 • Replace the pads if necessary..the shock button was Shock has been advised but the shock When next prompted, press the Shock not pressed button has not been pressed within 30 button to deliver shock. seconds. HEARTSTART FRx 861305 OWNER’S MANUAL...
  • Page 57 If it passes, store the defibrillator within the recommended temperature range. • The defibrillator has detected an error • Contact Laerdal for service if during a self-test or cannot perform a needed. self-test, or the Shock button is damaged.
  • Page 58 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 59 RF transmitters, an electromagnetic site survey should be considered. 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...
  • Page 60 Recommended separation distances between portable 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 maintaining a...
  • Page 61 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 62 Notes HEARTSTART FRx 861305 OWNER’S MANUAL...
  • Page 63 Intentionally blank.
  • Page 64 United Kingdom Belgium & Luxembourg Laerdal Medical Ltd. Bedrijvencentrum Laerdal House, Goodmead Road, Opington, Kent BR6 0HX Mechelsesteenweg 277, B-1800 Vilvoorde Tel: 01689 876634, Fax: 01689 873800 Belgium Tel: +32 2 253 36 96, Fax: 32-2-253 36 90 E-mail: customer.service@laerdal.co.uk Luxembourgh Tel: +31 40 208 58 00, Fax: +31 40 208 58 02 E-mail: info@laerdal.be...