LABORIE alpHaONE - Indications for Use; Contraindications; Components; Ph Capsule

4 Laborie alpHaONE User & Service Manual LBL-01791 [B]
Indications for Use
The pH Capsule System is indicated for use with the following patient candidates:
•
PatientswhoexperienceclassicsymptomsofacidreuxorheartburnandareconsideredasGastroesophageal
ReuxDisease(GERD)patients.
•
Patients who suffer from unexplained chronic pharyngitis, hoarseness, trachitis, or asthma and are considered
as patients having extra esophageal symptoms of GERD.
•
Patients undergoing PPI treatment for whom a healthcare professional needs to determine the effectiveness of
the treatment.
Contraindications
The pH Capsule System is contraindicated for use with the following patient candidates:
•
Patientswhoareconrmed(orsuspected)tosufferfromupperesophagealobstruction.
•
Patientswhoareconrmed(orsuspected)tosufferfromesophagealvaricesaccordingtogastroscopy,clinical
radiology or other examination.
•
Patientswhoareconrmedtosufferfromesophagealmucosaerosionaccordingtogastroscopyorother
examination.
•
Patientswhoareconrmed(orsuspected)tosufferfromcongenitaldigestivetractmalformation;
gastrointestinalobstruction;andperforation,stricture,orstulaofdigestivetractaccordingtoclinicalradiology
or other examination.
•
Patientswhohavehadbleedingtendencyorgastrointestinalbleedingintherecentsixmonthsorhavetaken
anticoagulant drugs for an extended period of time.
•
Patients who suffer from heart disease and are not stable.
•
Patientsimplantedwithapacemakerorothermedicaldevice.
•
Patients who have a history of allergy to polymer materials or metals including chromium, copper, cobalt,
andiron.
Components
The pH Capsule System comprises the pH capsule, delivery system, data recorder, data analysis software, and
relevantaccessories.Allcomponentsaredescribedinthesectionsthatfollow.
pH Capsule
The pH capsule (Figure1-2) is made up of a sensor, a gripper, and a signal acquisition module, sealed in a polymer
enclosure.
Gripper
pH sensor
Figure1-2: The pH Capsule