Philips 861304 owner manual Electromagnetic immunity

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Electromagnetic immunity

Philips Medical Systems

immunity test

electrostatic discharge (ESD)

IEC 61000-4-2

power frequency (50/60 Hz) magnetic field IEC 61000-4-8

radiated RF IEC 61000-4-3

IEC 60601

compliance

electromagnetic environment - guidance

test level

level

 

± 6 kV contact

± 6 kV contact

There are no special requirements with

± 8 kV air

± 8 kV air

respect to electrostatic discharge.a

 

3 A/m

3 A/m

Power frequency magnetic fields should

 

 

be at levels characteristic of a typical

 

 

location in a typical commercial/hospital

 

 

environment.

 

 

There are no special requirements for

 

 

non-commercial/non-hospital

 

 

environments.

10 V/m

[E1] V/m

Portable and mobile RF communications

80 MHz to 2.5

 

equipment should be used no closer to

 

any part of the HeartStart FRx, including

GHz

 

 

cables, than is absolutely necessary.b,c

 

 

 

 

The recommended separation distances

 

 

for various transmitters and the AED

 

 

are shown in the following table.

 

 

Interference may occur in the

 

 

vicinity of equipment marked

 

 

with the following symbol:

APPENDICES

NOTE 1.At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2.These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a.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. In these cases, it is important to minimize movement in the vicinity of the patient during rhythm analysis in order to ensure that the signal being analyzed accurately reflects the patient’s underlying heart rhythm.

b.The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13, 567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.

c.Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed 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 operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the HeartStart.

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Contents Edition 861304N E R ’ S M a N U a L Philips Medical Systems Quick Reference Intentionally blank HeartStart FRx Device Tracking About This Edition Edition HistoryCopyright Authorized EU RepresentativeContents Appendices Sudden Cardiac Arrest DescriptionState and local requirements Indications for UseTraining and practice For more information Package contents1A. Remove Pads Case from packaging Setting up the FRxPhilips Medical Systems Recommended accessories Overview Using the HeartStart FRxOpen the pads case as shown below. Peel off one pad Press the green on/off buttonFollow the FRx’s voice instructions 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 maintenanceDisposing of the FRx Cleaning the FRxPeriodic checks Troubleshooting tips Appendices Philips Medical Systems Accessories Appendices Glossary of terms Coaching, if selected, appropriate for infants and children HeartStart Event ReviewButton Infant/Child KeyPads See Smart Pads When a battery is insertedPatient care in the AED mode On/Off buttonWaveform See Smart biphasic waveform Standby modeBlinking green Ready light Consciousness, absence of respiration, and lack of a pulseShock is advised, as a reminder not to touch the patient Glossary of symbols/controlsStandby mode gives device status Symbol  #  Appendices Accessories Please read these warnings and precautions carefullyApproved accessories are used Hazard. Do not sterilize the FRx or its accessoriesPrecautions Environmental HeartStart FRx 861304 Defibrillator specificationsTechnical information PhysicalProtected Controls and indicatorsCategory Specifications Sealing Current a Defibrillation waveformNewborn 14 J/kg Disarm AED mode Adult shock delivery vectorCategory Energy Charge control Shock-to-shock cycle time Energy doseRhythm class Samplea size Performance Lower ECG analysis systemECG analysis performance HeartStart Smart Pads II Accessories specificationsInfant/Child Key M5070A battery and 989803139301 TSO C-142* batteryCategory Battery type Capacity Regulations Environmental considerationsEnvironment Overview Device options ConfigurationPatient treatment protocol options Is detected in a motionless NSA pause type SettingsDefibrillator conducts Background monitoring. If aInstructs Instructions provided at User that it is CPR prompt SettingsCPR1 Instructs the user to begin CPR CPR reminder voiceCPR Coaching infant/child ventilation instruction When an adult pads set isInstalled Pads set is installedRecommended action when you need to use the device Testing and troubleshootingTesting TroubleshootingTo make sure the pads have been removed from the case Troubleshooting while the FRx is being usedDefibrillator says To replace padsDefibrillator says To stop all motion Behavior Troubleshooting while the FRx is not being usedEmissions test Additional technical data required for European conformityElectromagnetic conformity Electromagnetic emissionsElectromagnetic immunity = 1.15√ P Rated maximum output power of transmitter W 100Separation distance according to frequency of transmitter m MHz to2.5 GHzAppendices Philips Medical Systems Intentionally blank Latin America Philips Medical Systems United StatesCanada Europe, Middle East, and Africa

861304 specifications

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