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The LIFEPAK 35 AC power adapter is an optional accessory intended to connect to the LIFEPAK 35 monitor/defibrillator to provide auxiliary power. The bracket and screws provided are intended to attach the power adapter to a wall or shelf.

The LIFEPAK 35 AC power adapter is intended for indoor environments and for fixed installation in ground transportation vehicles.

The LIFEPAK 35 AC Power Adapter is an optional accessory for use with only the LIFEPAK 35 monitor/defibrillator. This accessory contains: AC power adapter with output cable, mounting bracket, bracket screws, region-specific AC power cord (packed separately). The power adapter:

• Provides operating power to the monitor/defibrillator without batteries installed.
• Provides power to charge batteries installed in the monitor/ defibrillator.

The LIFEPAK 35 AC Power Adapter operates on 100 to 240 VAC line power. Installed batteries are charged whenever the power adapter is connected to the LIFEPAK 35 monitor/defibrillator. To help manage and maintain battery charge, the power adapter should be kept plugged into the defibrillator whenever possible.

This document is a 510(k) premarket notification for a medical device: the LIFEPAK® 35 AC Power Adapter. It does not describe a study involving an algorithm or AI.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types cannot be found in this document. This document pertains to a physical hardware accessory for a defibrillator.

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