The ResMed ApneaLink Air is a diagnostic medical device designed to collect data pertinent to the diagnosis of sleep-disordered breathing in adult patients. It records patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse, and respiratory effort during sleep. This information is utilized to produce a report for healthcare professionals that may support diagnosing sleep conditions or warrant further clinical investigation. It is intended for both home and hospital use under the supervision of a healthcare provider.
Intended Use
This device is intended to be used on the direction of healthcare professionals (HCP) and can aid in identifying sleep-disordered breathing in adults. It is suitable for usage in homes and hospitals.
Contraindications and Cautions
The user manual advises against using the ApneaLink Air system near an MRI device due to the potential for interference. It’s also highlighted that the device should not be operated in explosive atmospheres or in the presence of flammable anesthetics gases. Users are cautioned not to use the system if it, or any of its accessories, appears damaged in any way.
General Warnings
There are specific warnings listed including the following:
Warning:
Do not use the system if the accessories or the device itself are damaged.
Caution:
In the United States, the system is regulated and is available for sale only by prescription from a physician. Additionally, it’s important not to set up the system while it is connected to a personal computer via USB.
Manual:
Download: ResMed ApneaLink Air Patient Instructions Manual
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