Zephyr MATRx Plus, Инструкция по эксплуатации

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Intended Use and Cautions
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 oral appliance therapy 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, theaters� The
device is not intended for use near surgical equipment or magnetic resonance imaging equipment�
Contraindications
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This device is not to be used as an apnea monitor or in a life supporting or life sustaining situation
•
This device is not to be used by patients under the age of 18
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The MATRx plus device is MR unsafe
As a Sleep Theragnostic, the device is not recommended for use in patients who:
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Have loose teeth or advanced periodontal disease
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Have full dentures or dental implants
Notes
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The use of this device is only for the person that is was prescribed for
•
Remove Trays and discontinue the study if necessary