consensus_PMA_Age_Indications  

DevicePMAs@therightstef:P160026_S000 / 797-806 JSONTXT 2 Projects

Approval for the LIFEPAK 1000 Defibrillator, LIFEPAK 1000 Defibrillator Lithium-ion Rechargeable Battery, LIFEPAK 20 Defibrillator/ Monitor (Refurbished), LIFEPAK 20e Defibrillator/ Monitor, LIFEPAK 15 Monitor/Defibrillator, and LIFEPAK Lithium-ion Rechargeable Battery (for use with the LIFEPAK 15 Monitor/Defibrillator) These devices are indicated for use as follows: LIFEPAK 1000 DefibrillatorThe defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation. The defibrillator may be used with standard defibrillation pads only on adults and children who are 8 years old or more or who weigh more than 25 kg (55 lbs). The defibrillator may be used on children who are less than 8 years old or weigh less than 25 kg (55 lbs) with Infant/Child Reduced Energy Defibrillation Electrodes. LIFEPAK 20/20e Defibrillator/Monitors The AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patients ECG rhythm. In AED mode, the LIFEPAK 20 and LIFEPAK 20e defibrillator/monitor is not intended for use on pediatric patients less than 8 years old. LIFEPAK 15 Defibrillator/Monitors AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patients ECG rhythm. In AED mode, the LIFEPAK 15 monitor/defibrillator is not intended for use on pediatric patients less than 8 years old.

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