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nox A1 - Introduction; Intended Use; Contraindications; Scope

nox A1
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Nox A1 Manual
~ 7 ~
Introduction
Congratulations on choosing the Nox A1 recorder. The Nox A1 recorder is an American Academy of
Sleep Medicine (AASM) compliant body worn sleep recorder and is a part of the Nox Sleep System. Its
main function is to record physiological signals by use of built-in sensors and patient applied sensors.
The Nox A1 recorder has a built-in Bluetooth® module also allowing it to record signals from
compatible auxiliary devices. Placement of the recorder and connecting sensors is simple and makes
the setup quick and easy. The Nox A1 recorder is configured by the Noxturnal software from Nox
Medical, running on a PC, that also allows for the review, organization, analyzing, and summarizing of
all signals recorded by the device. The complexity of the study is defined by varying the number and
types of physiological signals measured, supporting both ambulatory and online sleep testing. During
online configuration of the Nox Sleep System, commands and data are sent between the Nox A1
recorder and the Noxturnal software by use of the Nox C1 Access Point from Nox Medical. The Nox A1
recorder can communicate over Bluetooth link, either direct or via the Nox C1 Access Point
(depending on the system configuration), with Noxturnal App from Nox Medical running on a mobile
platform for device control and online review of signals being recorded.
Intended Use
The Nox Sleep System is used as an aid in the diagnosis of different sleep disorders and for the
assessment of sleep.
The Nox Sleep System is used to measure, record, display, organize, analyze, summarize, and retrieve
physiological parameters during sleep and wake in patients greater than 2 years of age.
The Nox Sleep System allows the user to decide on the complexity of the study by varying the number
and types of physiological signals measured.
The Nox Sleep System allows for generation of user/pre-defined reports based on subject´s data.
The user of the Nox Sleep System are medical professionals who have received training in the areas of
hospital/clinical procedures, physiological monitoring of human subjects, or sleep disorder
investigation.
The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test
environments, including patient’s home.
Contraindications
The Nox Sleep System does not provide any alarms and is not intended to be used for continuous
monitoring where failure to operate can cause injuries or death of the patient.
Scope
This manual covers the use of the Nox A1 recorder and its components along with external sensors
and auxiliary devices that have been validated with the Nox Sleep System. The use of the Noxturnal
software application that is needed for device configuration, data download, review, and analysis as
well as the use of the Nox C1 Access Point that is needed for the online setup of the Nox Sleep System
are covered in:
Noxturnal Manual
Nox C1 Manual
This manual is only intended for professionals (healthcare professionals and service personnel) with
relevant qualifications and skills. Additional material can be found on the Nox Medical Website.

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