Philips 861304 owner manual ECG analysis system, ECG analysis performance

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37

ECG analysis system

Philips Medical Systems

category

function

shockable rhythms

non-shockable rhythms

pacemaker detection

artifact detection

analysis protocol

specifications

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.

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. Also, for safety reasons, some VT rhythms often associated with circulation may not be interpreted as shockable rhythms.

On detection of any non-shockable rhythm, prompts user to perform CPR if needed.

Pacemaker artifact is removed from the signal for rhythm analysis.

If electrical “noise” (artifact) is detected that interferes with accurate rhythm analysis, analysis will be delayed until the ECG signal is clean.

Depending on results of analysis, either prepares for shock delivery or provides a pause. For details of protocol, see Appendix F, “Configuration.”

APPENDICES

ECG analysis performance

 

ECG test

meets AHA recommendationsb for adult defibrillation

 

observed

90% one-sided

rhythm class

samplea size

 

 

performance

lower

 

 

 

confidence limit

 

 

 

 

shockable rhythm —

300

sensitivity >90%

(87%)

ventricular fibrillation

 

 

 

shockable rhythm —

100

sensitivity >75%

(67%)

ventricular tachycardia

 

 

 

non-shockable rhythm —

300

specificity >99%

(97%)

normal sinus rhythm

 

 

 

non-shockable rhythm —

100

specificity >95%

(92%)

asystole

 

 

 

 

 

 

 

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Contents 861304 N E R ’ S M a N U a LEdition Philips Medical Systems Quick Reference Intentionally blank HeartStart FRx Copyright About This Edition Edition HistoryAuthorized EU Representative Device TrackingContents Appendices Sudden Cardiac Arrest DescriptionIndications for Use Training and practiceState and local requirements For more information Package contents1A. Remove Pads Case from packaging Setting up the FRxPhilips Medical Systems Recommended accessories Overview Using the HeartStart FRxPress the green on/off button Follow the FRx’s voice instructionsOpen the pads case as shown below. Peel off one pad If a shock is needed Press the flashing orange Shock button if instructedIf a shock is not needed Treating infants and childrenKey if available Infant/Child Key When emergency medical services arrivePhilips Medical Systems After each use After using the HeartStart FRxFRx data storage Maintaining the HeartStart FRx Routine maintenanceCleaning the FRx Periodic checksDisposing of the FRx Troubleshooting tips Appendices Philips Medical Systems Accessories Appendices Glossary of terms Button HeartStart Event ReviewInfant/Child Key Coaching, if selected, appropriate for infants and childrenPatient care in the AED mode When a battery is insertedOn/Off button Pads See Smart PadsBlinking green Ready light Standby modeConsciousness, absence of respiration, and lack of a pulse Waveform See Smart biphasic waveformGlossary of symbols/controls Standby mode gives device statusShock is advised, as a reminder not to touch the patient Symbol  #  Appendices Approved accessories are used Please read these warnings and precautions carefullyHazard. Do not sterilize the FRx or its accessories AccessoriesPrecautions Technical information HeartStart FRx 861304 Defibrillator specificationsPhysical EnvironmentalControls and indicators Category Specifications SealingProtected Current a Defibrillation waveformCategory Energy Charge control Shock-to-shock cycle time Disarm AED mode Adult shock delivery vectorEnergy dose Newborn 14 J/kgECG analysis system ECG analysis performanceRhythm class Samplea size Performance Lower HeartStart Smart Pads II Accessories specificationsM5070A battery and 989803139301 TSO C-142* battery Category Battery type CapacityInfant/Child Key Environmental considerations EnvironmentRegulations Overview Device options ConfigurationPatient treatment protocol options Defibrillator conducts NSA pause type SettingsBackground monitoring. If a Is detected in a motionlessCPR1 Instructs the user to begin CPR CPR prompt SettingsCPR reminder voice Instructs Instructions provided at User that it isInstalled When an adult pads set isPads set is installed CPR Coaching infant/child ventilation instructionTesting Testing and troubleshootingTroubleshooting Recommended action when you need to use the deviceDefibrillator says Troubleshooting while the FRx is being usedTo replace pads To make sure the pads have been removed from the caseDefibrillator says To stop all motion Behavior Troubleshooting while the FRx is not being usedElectromagnetic conformity Additional technical data required for European conformityElectromagnetic emissions Emissions testElectromagnetic immunity Separation distance according to frequency of transmitter m Rated maximum output power of transmitter W 100MHz to2.5 GHz = 1.15√ PAppendices Philips Medical Systems Intentionally blank Canada Philips Medical Systems United StatesEurope, Middle East, and Africa Latin America

861304 specifications

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