LABORIE alpHaONE - Introduction; The Alphaone System 3; Intended Use 3

LBL-01791 [B] Laborie alpHaONE User & Service Manual 3
1 Introduction
The alpHaONE System
The alpHaONE pH Capsule Monitoring Systems (hereinafter referred as pH Capsule System) is intended for use in
examininggastroesophagealreuxdisease(GERD).ThesystemcancontinuouslymonitorpHvariationwithinthe
esophagus for up to 96 hours. The pH value monitored by the capsule is transmitted by means of radio frequency to a
data recorder (Figure1-11)thatstorestheinformation.Aftertheexamination,thedataisdownloadedthroughthepH
Capsule System’s software for analysis of the pH variation and diagnosis.
Figure1-1: The alpHaONE Data Recorder and Delivery System
Intended Use
The alpHaONE is intended to record, store, view and analyze pH in the esophagus to assist in the diagnosis and
evaluationofreuxbytrainedandlicensedhealthcareprofessionals.ApHCapsule,whichisinsertedintothe
esophagus, measures the pH levels.