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Use of the device for defibrillation is indicated on victims of cardiac arrest with apparent lack of circulation as indicated by

• Unconsciousness .
• Absence of breathing, and .
• Absence of pulse and other signs of circulation. .

When the victim is less than 8 years old or weighs less than 55 lb. (25 kg), use ZOLL pediatric defibrillation electrodes: Do not delay therapy to determine the patient's exact age or weight.

The device is also intended for use when ECG monitoring is indicated to evaluate the patient's heart rate or ECG morphology.

The ZOLL AED Pro® is a portable, battery powered automated external defibrillator (AED) that uses voice prompts and visual messages to provide feedback to a user attempting a cardiac arrest rescue. The AED Pro acquires and analyzes an adult or pediatric patient's ECG signal and, if a shockable rhythm is detected, recommends delivery of a defibrillation shock via voice and visual prompts.

The ZOLL AED Pro software, which currently supports the 2005 American Heart Association Guidelines for CPR and ECC, has been revised to optionally support the 2010 American Heart Association Guidelines for CPR and ECC. The specific changes include:

• changing the depth indicator on the device screen from 1.5 inches to 2.0 inches .
• prompting the user to "push harder" when compressions are less than 2.0 inches . instead of less than 1.5 inches in the previous release
• adding a text prompt to remind the rescuer to "Fully Release" the patient's . chest during CPR

The provided document describes a 510(k) premarket notification for a software update to the ZOLL AED Pro, aligning it with the 2010 American Heart Association Guidelines for CPR and ECC. The focus is on CPR monitoring and defibrillation.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a pass/fail quantifiable manner for the software update, but rather describes the changes made to comply with new guidelines and implies that the device meets these new guideline requirements. The performance testing section states that the device "meets all of its functional requirements and performance specifications" and "demonstrates that its features and functions are substantially equivalent to that of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness."

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