• The AED must have a high-resolution liquid crystal display with capacitive touch panel.
• The AED must have an “ON/OFF” button.
• The AED must have a “SHOCK” button that illuminates when the unit is charged and ready to deliver a shock.
• During clinical use, the AED must display the number of shocks and elapsed time since the AED was powered on.
• The AED must display text prompts related to issued voice prompts.
• The AED must utilize a low-energy Rectilinear Biphasic™ waveform.
• The AED and advisory protocols shall comply with the recommendations in the American Heart Association (AHA), European Resuscitation Council (ERC) or International Liaison Committee on Resuscitation (ILCOR) Guidelines 2015 for AEDs.
• The AED and advisory protocols shall comply with the recommendations in the American Heart Association (AHA), European Resuscitation Council (ERC) or International Liaison Committee on Resuscitation (ILCOR) Guidelines 2015 for chest compressions (CPR).
• The AED and advisory protocols shall comply with the recommendations in the American Heart Association (AHA), European Resuscitation Council (ERC) or International Liaison Committee on Resuscitation (ILCOR) Guidelines 2015 for single shocks.
• The energy settings must be user configurable with a maximum energy setting of 200 joules and a minimum of 120 joules for ADULT victims.
• The AED must invoke a specific pediatric algorithm when in pediatric operating mode, with a maximum setting of 85 joules and a minimum of 50 joules.
• The AED must allow the user to manually switch from adult mode to pediatric mode with the press of a button and announce patient type selection once changed.
• In pediatric mode, the AED must:
– Perform heart rhythm analysis using a pediatric-specific algorithm
– Deliver child/pediatric-specific energy levels
• For a pediatric victim, heart rhythm analysis must detect tachycardia at a heart rate no lower than 200 beats per minute.
• The AED must be able to deliver a shock within 25 seconds of power on.
• The AED must be able to deliver a shock within 8 seconds of rhythm analysis beginning.
• The AED must record patient impedance and delivered energy shall be adjusted based on patient impedance.
• A version of the AED must be configurable to display a patient ECG.
• A version of the AED must be configurable to turn voice recording ON/OFF.
• The AED must have two operating modes, configurable by the user:
– Lay rescuer mode with graphical images displayed on the LCD designed to assist a lay responder in the use of the AED
– Professional/trained rescuer mode with limited graphics and a CPR dashboard displaying compression rate, depth, patient’s ECG and a CPR cycle countdown timer
– For professional rescuer mode, users must be able to configure the ECG display ON/OFF
• The manufacturer of the AED must have a history of at least 20 years’ experience providing cardiologic medical devices.
• The AED shall employ a prominent indicator to signify its state of readiness; simple indicators (i.e., LEDs) are not an acceptable alternative.
• The AED shall perform an automated self-test at least every 7 days depending on user configuration.
• The AED shall allow users to configure the self-test frequency.
• The AED shall perform the following self tests:
– When a battery is inserted
– When the AED is powered on
– When the user performs a manual self-test
– Automatic weekly
– Automatic monthly
• The AED self-test shall test/report on the following:
– Battery Capacity and Status
– Defibrillation Electrodes Connection
– Defibrillation Electrode Type
– Defibrillation Electrode and Battery Expiration Date
– ECG Circuitry
– Defibrillator Charge and Discharge Circuitry (2-joule test)
– Microprocessor Hardware/Software
– CPR Circuitry and Sensor (if electrodes with CPR functionality are connected)
– Audio Circuitry
– 2-joule Charge Test (weekly/daily automatic self-test)
– 200-joule Charge Test (monthly automatic self-test)
• The AED shall store the results of the most recent self-test in its internal memory.
• The AED shall store all faults or failed self-test results in its internal memory.