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Introduction
Intended Use
The MATRx plus is indicated for use by a lay person in a home and hospital environment under the direction of a
Healthcare Professional (HCP).
MATRx plus records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse,
respiratory effort and body position during sleep. MATRx plus uses these recordings to produce a report for the
HCP that may aid in the diagnosis and assessment of sleep disordered breathing for adult patients.
The MATRx plus device may also be used with an automated mandibular positioner that uses feedback control
to record changes in the patient’s respiratory status related to repositioning of the mandible during an overnight
study.
MATRx plus uses these recordings to produce a report for the HCP that can be used to prospectively identify
patients with mild to moderate obstructive sleep apnea who may be suitable for therapy with an oral appliance
and to recommend a target mandibular position.
The use of the device does not replace the need for follow-up testing to determine the initial and ongoing
effectiveness of the therapy as recommended by clinical practice guidelines.
Product Overview
MATRx plus is a portable recorder used to conduct an overnight sleep study in a clinical, hospital or home
environment excluding: outdoors, vehicles, train stations, bus stations, airports, museums, theatres. This device is
not intended for use near surgical equipment or magnetic resonance imaging equipment.
The device is deployed by a healthcare professional (e.g. sleep technician, dental technician, physician, nurse, etc.).
MATRx plus records breathing through nasal airflow, oxygen saturation and abdominal effort while the patient
sleeps. The device can be used in an Oral Appliance (OA) Study to determine in which patients with obstructive
sleep apnea (OSA) mandibular advancement by an oral appliance will reduce obstruction of airflow, thereby
identifying patients suitable for oral appliance therapy (OAT). This is accomplished by a temporary appliance fit
to the patient’s teeth that automatically incrementally and reversibly advances the patient’s mandible forward
in response to respiratory information detected. The data collected from the OA Study is automatically analysed
and an assessment of whether the patient is expected to achieve successful therapy from the oral appliance is
provided.
The device selects patients as suitable for oral appliance therapy and recommends a target mandibular position
based on a success criterion of an oxygen desaturation index (ODI) of less than 10 events per hour with a 4%
desaturation criterion.
