Introduction; Intended Use - Respironics Alice PDx Provider Manual

1
AlicePDx
Provider Guide

1. Introduction

AlicePDx is a portable, diagnostic recording device. It may be used for obstructive sleep apnea
screening as well as for follow-up and diagnostic assessment. The device may be used in a sleep lab
or clinical setting by trained professionals, and it may be used at home by patients as directed by
their healthcare provider.
The AlicePDx device is capable of recording various physiologic inputs and storing the data locally
on the removable storage card. The device may also be connected directly to a computer running
the Sleepware software application. Sleepware can display live or pre-recorded data in a resolution
consistent with the computer hardware specifications.

Intended Use

The AlicePDx is a multi-function recording device that collects and stores physiological signals. The
recorded data is downloaded, presented graphically on a computer screen, and may be printed
for diagnostic review by clinicians/physicians to aid in the diagnosis of respiratory sleep disorders
or other physiological disorders. The AlicePDx may be used on adults in the home or hospital/
institutional environment.
The device does not provide alarms and is not intended for use as an automated apnea or
cardiac monitor.
Provider Guide