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ApLab In Home OSA Screening Device
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Manufacturer:
AGC Biomedical Devices, Inc.
Content of Package:
Device, Instructions, Prepaid Shipping Tag |
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DESCRIPTION:
Although an estimated 15% of the adult US population is suspected
of having obstructive sleep apnea (OSA), only about 5% to 7% of
the approximate 20 million Americans with OSA have been diagnosed
due to the lack of simple screening equipment. AGC Biomed's ApLab
is designed to provide people with a low cost screening device to
help determine which patients are suffering from OSA.
Patients begin by straping on the beeper-sized data logger to their
arm and place the nasal cannula under their nose. Then they pull
a small plastic strip from the device, which activates a small internal
computer. The unit will run for a full 8 hours measuring every breath
and looking for breathing patterns. The software automatically identifies
obstruction events, recording their time and duration. The patient
then mails the ApLab back to AGC Biomed in the pre-postage paid
box included with the device. The data is then downloaded and a
report is generated. This report is sent on back to your physician
who can then anylize the data and determine if you may need to be
treated for Sleep Apnea.
The standard procedure today is for a patient with suspected sleep
disorders to visit a sleep clinic for an overnight study. The ApLab
has been designed as an at-home, easy to use device which measures
one channel extremely well. Patients tend to sleep better at home
in their own bedroom as opposed to going to a sleep lab where they
are in a foreign enviornment. This allows for a more comfortable
form of testing for the patient. Also, since many sleep centers
have waiting lists that can be months long, the ApLab is a perfect
solution for someone who may have to wait such a long time to be
tested.
The ApLab provides measurements of apneas and hypopneas that are
equivalent to those of a standard polyosmnogram (PSG). During clinical
trials using an apnea hypopnea index greater than 10, the ApLab
had a positive predictive value of 100% versus the PSG.
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