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Automatic external defibrillators (AED) approved by FDA


10th July 2019

AEDs like the HeartStart OnSite (M5066A) and HeartStart Home (M5068A), Primary Battery (Model M5070A), SMART Pads Cartridges (Adult Model M5071A) and Infant/Child (Model M5072A) has been approved by the FDA to market these products.

The automatic external defibrillators (AED), HeartStart OnSite (M5066A) and HeartStart Home (M5068A) are designed to treat people experiencing sudden cardiac arrest (SCA), a medical condition in which the heart suddenly and unexpectedly stops beating.

HeartStart OnSite model is intended for public access defibrillation and HeartStart Home model is for at-home use.

These defibrillators use two multifunction defibrillation electrodes, placed on patient’s chest, to get a patient’s electrical activity of the heart electrocardiogram (ECG).

If any abnormal heartbeat is detected by this device, it advises the user that a “shock” from the defibrillator to restore the heart’s normal pumping rhythm is appropriate. Voice prompts will be provided by the user interface to guide the user through rescue process including shock delivery or cardiopulmonary resuscitation (CPR). When required, the patient gets the electrical shock through the defibrillator electrodes.

These devices should not be used when a patient is conscious and breathing normally.


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