Page 3 - Hear tStar t FRx Defibrillator; QUICK REFERENCE
Ph ilip s M e di ca l Sy st e m s Hear tStar t FRx Defibrillator QUICK REFERENCE
Page 5 - Hear tStar t FRx
Ph ilip s M e di ca l Sy st e m s Hear tStar t FRx 861304Automated External Defibrillator 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 surviva...
Page 7 - CONTENTS; Introduction to the HeartStart FRx
Ph ilip s M e d ic al Sy st ems i CONTENTS 1 Introduction to the HeartStart FRx Description ........................................................................................................... 1 Sudden Cardiac Arrest ...............................................................................
Page 8 - APPENDICES
P h ilip s Me d ic al S ys te m s ii HEARTSTART FRx 861304 OWNER’S MANUAL APPENDICES A Accessories ..................................................................................................................... 21 B Glossary of terms ...............................................................
Page 9 - Introduction to the Hear tStar t FRx; Description; young or old, male or female
Ph ilip s M e di ca l Sy st e m s 1 1 Introduction to the Hear tStar t 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 ...
Page 10 - Indications for Use; does not respond when shaken, and; Training and practice
2 Philip s Me di ca l Syst e m s HEARTSTART FRx 861304 OWNER’S MANUAL Indications for Use The FRx should be used to treat someone you think may be a victim of SCA. A person in SCA: • does not respond when shaken, and • is not breathing normally. If in doubt, apply the pads. Follow the voice instruct...
Page 11 - For more information; Technical Reference Manual; Setting up the Hear tStar t FRx; Package contents; Check the contents of the FRx box to be sure it contains:
3 Ph ilip s M e di ca l Sy st e m s 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 exte...
Page 12 - Setting up the FRx; Do not open the pads case until you need to use the pads in an
4 Philip s Me di ca l Syst e m s HEARTSTART FRx 861304 OWNER’S MANUAL IMPORTANT NOTE: The FRx is designed to be used with a carry case. A number of carry cases are offered to meet the needs of your individual defibrillation program. These include a standard carry case and a hard-shell carry case. Se...
Page 14 - Recommended accessories; scissors — for cutting the victim’s clothes if needed
6 Philip s Me di ca l Syst e m s HEARTSTART FRx 861304 OWNER’S MANUAL Recommended accessories It is always a good idea to have a spare battery and a spare pads set. Other things that are useful to keep with the FRx include: • scissors — for cutting the victim’s clothes if needed • disposable gloves ...
Page 15 - Using the Hear tStar t FRx; IMPORTANT NOTE; Overview; If you think someone is in SCA, act quickly and calmly.
7 Ph ilip s M e di ca l Sy st e m s 3 Using the Hear tStar t 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 , as...
Page 16 - Press the green on/off button; Press the On/Off button; Follow the FRx’s voice instructions; Open the pads case as shown below. Peel off one pad.
8 Philip s Me di ca l Syst e m s HEARTSTART FRx 861304 OWNER’S MANUAL STEP 1: Press the green on/off button Press the On/Off button to 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. STEP 2: Follo...
Page 18 - If a shock is not needed:; Treating infants and children; immediately
10 Philip s Me di ca l Syst e m s HEARTSTART FRx 861304 OWNER’S MANUAL If a shock is not needed: The blue i-button comes on solid, to show that it is safe to touch the patient. The FRx also tells you to perform CPR if needed. (If CPR is not needed – for example, if the patient is moving or regaining...
Page 19 - and provide optional infant/; Insert the Infant/Child
11 Ph ilip s M e di ca l Sy st e m s 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 slo...
Page 20 - DO NOT DELAY TREATMENT.; When emergency medical services arrive; stored in the FRx. To hear the summary data, hold
12 Philip s Me di ca l Syst e m s HEARTSTART FRx 861304 OWNER’S MANUAL If the victim is under 55 pounds or 8 years old, but you do NOT have an Infant/Child Key: • 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 b...
Page 22 - After using the Hear tStar t FRx; After each use; Check the outside of the FRx for signs of damage, dirt, or
14 Philip s Me di ca l Syst e m s HEARTSTART FRx 861304 OWNER’S MANUAL 4 After using the Hear tStar t FRx After each use 1. 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 co...
Page 23 - FRx data storage; Details about data transfer and
15 Ph ilip s M e di ca l Sy st e m s 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 Even...
Page 24 - the FRx’s rhythm analysis decisions (entire incident); Maintaining the Hear tStar t FRx; Routine maintenance; WARNING
16 Philip s Me di ca l Syst e m s 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) 5 Maintaining the Hear tStar t FRx Routine maintenance The FRx is ver...
Page 25 - Periodic checks; Replace any used, damaged or expired supplies and accessories.; Cleaning the FRx
17 Ph ilip s M e di ca l Sy st e m s Periodic checks Other than the checks recommended after each use of the FRx, maintenance is limited to periodically checking the following: • Check the green Ready light. If the green Ready light is not blinking, see Troubleshooting Tips, below. • Replace any use...
Page 26 - Troubleshooting tips; If the Ready light is solid: The FRx is in use or running a self-test.
18 Philip s Me di ca l Syst e m s HEARTSTART FRx 861304 OWNER’S MANUAL Troubleshooting tips The FRx’s green Ready light is your guide to knowing if the defibrillator is ready for use. • If the Ready light is blinking: The FRx has passed the battery insertion self-test and the last periodic self-test...
Page 28 - Notes
Philip s Me di ca l Syst e m s HEARTSTART FRx 861304 OWNER’S MANUAL Notes
Page 29 - Accessories
21 Ph ilip s M e di ca l Sy st e m s APP E ND IC ES A 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] • ...
Page 31 - Glossar y of terms
23 Ph ilip s M e di ca l Sy st e m s APP E ND IC ES B Glossar y of terms The terms listed in this Glossary are defined in the context of the Philips HeartStart FRx Defibrillator 861304 and its use. AED Automated external defibrillator (a semi-automatic defibrillator). AED mode The standard treatment...
Page 35 - Glossar y of symbols/controls
27 Ph ilip s M e di ca l Sy st e m s APP E ND IC ES C Glossar y 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 i...
Page 39 - Warnings and Precautions; Warnings
31 Ph ilip s M e di ca l Sy st e m s APP E ND IC ES D 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 p...
Page 40 - Precautions
32 Philip s Me di ca l Syst e m s HEARTSTART FRx 861304 OWNER’S MANUAL AP P E ND IC ES pads Do not allow the pads to contact other electrodes or metal parts that are in contact with the patient. Precautions device handling The FRx was designed to be sturdy and reliable for many different use conditi...
Page 41 - Technical information; HeartStart FRx 861304 Defibrillator specifications; Physical
33 Ph ilip s M e di ca l Sy st e m s APP E ND IC ES E 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, ...
Page 42 - Controls and indicators
34 Philip s Me di ca l Syst e m s HEARTSTART FRx 861304 OWNER’S MANUAL AP P E ND IC ES Controls and indicators sealing Meets IEC 529 class IPx5 for jetting water and class IP5x for solid objects (dust protected). ESD/EMI (radiated and immunity) See Appendix F. aircraft: method Meets RTCA/DO-160D:199...
Page 43 - Defibrillation waveform
35 Ph ilip s M e di ca l Sy st e m s APP E ND IC ES 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 ...
Page 45 - ECG analysis system
37 Ph ilip s M e di ca l Sy st e m s APP E ND IC ES ECG analysis system ECG analysis performance 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. shockab...
Page 46 - Accessories specifications
38 Philip s Me di ca l Syst e m s HEARTSTART FRx 861304 OWNER’S MANUAL AP P E ND IC ES Accessories specifications HeartStart SMART Pads II 989803139261 non-shockable rhythm — all other non-shockable rhythms c 450 specificity >95% (88%) a. From Philips Medical Systems Heartstream ECG rhythm databa...
Page 48 - Environmental considerations
40 Philip s Me di ca l Syst e m s HEARTSTART FRx 861304 OWNER’S MANUAL AP P E ND IC ES Environmental considerations By complying with your national or local regulations regarding disposal of electric, electronic, and battery waste, you can make a positive contribution to our shared environment. prod...
Page 49 - Configuration
41 Ph ilip s M e di ca l Sy st e m s APP E ND IC ES F 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...
Page 50 - Patient treatment protocol options
42 Philip s Me di ca l Syst e m s HEARTSTART FRx 861304 OWNER’S MANUAL AP P E ND IC ES Patient treatment protocol options parameter settings default default description “call EMS” voice reminder timing • At power on (when the user turns on the FRx) • At power on and at the start of the first patient...
Page 54 - Testing and troubleshooting; Testing; Troubleshooting; Recommended action when you need to use the device
46 Philip s Me di ca l Syst e m s HEARTSTART FRx 861304 OWNER’S MANUAL AP P E ND IC ES G 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 Techn...
Page 55 - Troubleshooting while the FRx is being used
47 Ph ilip s M e di ca l Sy st e m s APP E ND IC ES 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...
Page 57 - Troubleshooting while the FRx is not being used
49 Ph ilip s M e di ca l Sy st e m s APP E ND IC ES Troubleshooting while the FRx is not being used (green Ready light is not on) Press the blue i-button to check defibrillator status, and follow any instructions the device gives. behavior possible cause recommended action chirps or i-button flashes...
Page 58 - Additional technical data required for European conformity; Electromagnetic conformity; Electromagnetic emissions
50 Philip s Me di ca l Syst e m s HEARTSTART FRx 861304 OWNER’S MANUAL AP P E ND IC ES H Additional technical data required for European conformity Electromagnetic conformity Guidance and manufacturer’s declaration: The HeartStart FRx is intended for use in the electromagnetic environment specified ...
Page 59 - Electromagnetic immunity
51 Ph ilip s M e di ca l Sy st e m s APP E ND IC ES Electromagnetic immunity immunity test IEC 60601 test level compliance level electromagnetic environment - guidance electrostatic discharge (ESD) IEC 61000-4-2 ± 6 kV contact ± 8 kV air ± 6 kV contact ± 8 kV air There are no special requirements wi...
Page 64 - Philips Medical Systems is par t of
P O W E R T O S A V E A L I F E Philips Medical Systems is par t of Royal Philips Electronics REF: 989803138731 Philips Medical Systems United States Philips Medical Systems2301 Fifth Avenue, Suite 200Seattle, WA, USA 98121(800) 263-3342 Canada Philips Medical Systems 281 Hillmount Road Markham, Ont...