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The Watch-PAT200U (WP200U) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200U is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake), snoring level and body position. The WP200U generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI"), PAT sleep staging identification (PSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position (SBP) sensor. The WP200U's PSTAGES and SBP provide supplemental information to its PRDI/PAHI. The WP200U's PSTAGES and SBP are not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted.

The Watch-PAT200U System (WP200U) is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200U is a diagnostic aid for the detection of sleep related breathing disorders [Respiratory disturbance index (RDI), apnea - hypopnea index (AHI)] and sleep staging (Rapid Eye Movement (REM), Light Sleep, Deep Sleep and Wake) based on Peripheral Arterial Tonometry (PAT), a non-invasive technology. According to the physician discretion, the WP200U may be connected to an external integrated snoring and body position (SBP) sensor. The WP200U device consists of the following: (1) a unified PAT and pulse oximeter probe which is used to detect the PAT signal and to measure blood oxygen saturation; (2) an embedded actigraph, which is used to determine periods of sleep based on the motion of the wrist; (3) external integrated snoring and body position sensor - SBP (Optional); (4) electronics, which include a controller that records the signals provided by the PAT finger probe, oximeter, actigraph and SBP; (5) the device software; and (6) a power supply. The Watch-PAT200U is identical to the already cleared Watch-PAT200S-3 except for Itamar Medical pulse oximetry which replaces the existing Nonin pulse oximeter.

The Watch-PAT200S-3 (WP200S-3) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200S-3 is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake), snoring level and body position. The WP200S-3 generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI"), PAT sleep staging identification (PSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position (SBP) sensor. The WP200S-3's PSTAGES and SBP provide supplemental information to its PRDI/PAHI. The WP200S-3's PSTAGES and SBP are not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted.

The Watch-PAT200S-3 System (WP200S-3) is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200S-3 is a diagnostic aid for the detection of sleep related breathing disorders [Respiratory disturbance index (RDI), apnea – hypopnea index (AHI)] and sleep staging (Rapid Eye Movement (REM), Light Sleep, Deep Sleep and Wake) based on Peripheral Arterial Tonometry (PAT), a non-invasive technology. According to the physician discretion, the WP200S-3 may be connected to an external integrated snoring and body position (SBP) sensor. The WP200S-3 device is worn on the wrist and consists of the following: (1) a finger PAT probe, which is used to detect the PAT signal; (2) an embedded pulse oximeter using a second probe that is attached to another finger, for measuring blood oxygen saturation; (3) an embedded actigraph, which is used to determine periods of sleep based on the motion of the wrist; (4) external integrated snoring and body position sensor - SBP (Optional); (5) electronics, which include a controller that records the information supplied by the PAT finger probe, oximeter, actigraph and SBP, (6) the device software; and (7) a power supply. The Watch-PAT200S-3 is identical to the already cleared Watch-PAT200S-2 with the addition of an optional snoring level and body position sensor and the required electronic and software modification. The integrated sensor (SBP) is an optional external hardware which can be connected to the WP200S-3 device and attached to the patient's chest right under the sternal notch for recording snoring and body position signals.