LIFEPAK 35 monitor/defibrillator - Physiologic-monitoring defibrillation system

Intended purpose

The LIFEPAK 35 monitor/defibrillator is a portable multifunction device that is intended to provide monitoring functions; synchronized cardioversion; non-invasive pacing; and defibrillation therapy, with a rhythm recognition detection algorithm that can analyse the ECG while CPR is being performed. The LIFEPAK 35 monitor/defibrillator is intended for use by trained Basic Life Support (BLS) and Advanced Life Support (ALS) medical professionals in both in-hospital and out-of-hospital and clinical transport environments. The LIFEPAK 35 monitor/defibrillator is designed for use in a variety of professional healthcare facilities such as emergency rooms, catheterization laboratories, electrophysiological laboratories, operating rooms, on crash carts for portable emergency response throughout the hospital, as well as out-of-hospital response including EMS indoor environments, EMS outdoor environments, idle and in-motion EMS vehicles such as road ambulances, and other clinical environments. The LIFEPAK 35 monitor/defibrillator is not for use during air transport.

Functional description

When used with the appropriate accessories the device provides the following: Electrocardiography (ECG) Monitoring, 12/15-Lead ECG Analysis, Oxygen Saturation (SpO2) Monitoring, Carbon Monoxide (SpCO) and Methemoglobin (Met) Monitoring, Capnography (EtCO2) Monitoring, Invasive Pressure (IP) Monitoring, Non-Invasive Blood Pressure (NIBP), Temperature Monitoring, Vital Sign Trending, Automated External Defibrillation (AED), Manual Defibrillation, Synchronized Cardioversion, and Noninvasive Pacing.