INTRODUCTION TO THE ZZZPAT. Itamar Medical Watch-PAT 200, Watch-PAT 100

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1 Introduction to the zzzPAT

1.1 Intended Use of the Watch-PAT100 & Watch-PAT200

The Watch-PAT100 ("WP100") and Watch-PAT200 (“WP200”) are non-invasive home care devices for use with patients suspected to have sleep related breathing disorders.

The WP100 and WP200 devices are used as a diagnostic aid for the detection of sleep-related breathing disorders and sleep staging (Rapid Eye Movement (REM)

Sleep, Light Sleep and Deep Sleep). The devices generate a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index

("PAHI") and PAT sleep staging identification ("PSTAGES"). The devices' "PSTAGES" provides supplemental information to its PRDI/PAHI. The devices' "PSTAGES" is 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 WP100 and WP200 are not indicated for children less than 17 years old.

1.2 The zzzPAT S/W – Definition

The zzzPAT is an analysis software package used with the WP100 or WP200 devices to aid in diagnosis of sleep related breathing disorders and detects REM, Light Sleep,

Deep Sleep and Wake stages. The zzzPAT S/W displays the signals recorded by the

WP100 or WP200 devices, automatically identifies breathing disordered events and

REM, Light Sleep, Deep Sleep stages, and generates a comprehensive report for the physician.

1.3 Overview

Obstructive sleep apnea syndrome (OSAS) is considered a major public health problem. The prevalence of the syndrome is estimated at 2% to 5% in the adult population. It is characterized by recurrent events of complete or partial obstruction of the upper airways during sleep, often leading to hypoxemia, and/or arousals associated with sympathetic nervous system activation. The diagnosis and assessment of the sleep apnea patient is based on the Respiratory Disturbance Index

(RDI), the number of Apneas, Hypopneas and Respiratory Effort Related Arousals

(RERA) per hour of sleep and/or apnea-hypopnea index (AHI), along with sleep architecture. The common consequences of this sleep disruption are daytime sleepiness, poor daytime performance and increased vulnerability to accidents.

Cardiovascular complications such as systemic/pulmonary hypertension, ischemic heart disease and arrhythmias are the major sequel of OSAS in the adult population.

The WP100 and WP200 are worn on the wrist and utilizes a plethysmographic based finger–mounted probe, to measure the PAT (Peripheral Arterial Tone) signal. The PAT zzzPAT 4.2

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signal is a measurement of the pulsatile volume changes in the fingertip arteries which reflects the relative state of the arterial vasomotor activity, and thus indirectly the level of sympathetic activation. Peripheral arterial vasoconstriction, which mirrors sympathetic activation, is shown as attenuation in the PAT signal amplitude. The PAT signal is recorded continuously and stored on a removable flash disk along with pulse rate (derived from the PAT signal), data from a built in pulse-oximeter (the sensor is mounted on an adjacent finger) and an actigraph (embedded in the device). Following the sleep study, in an offline procedure, the recordings are automatically downloaded and analyzed using the proprietary zzzPAT software.

The zzzPAT algorithms use the four WP100 or WP200 channels (PAT, Pulse Rate,

Oxygen saturation and actigraphy) for the detection of sleep related breathing disorders and sleep staging (Rapid Eye Movement (REM), Light Sleep, Deep Sleep and Wake). The software issues comprehensive reports of the study, with statistics and graphic presentation of the results. The whole night data can be viewed and the automatically detected events can be revised manually.

This manual provides the information necessary for routine use of the zzzPAT software.

Restrictions

The tracings and calculations provided by the WP100 or WP200 systems are intended as an aid for Sleep Breathing Disorders diagnosis. They are explicitly not to be regarded as a sole incontrovertible basis for clinical diagnosis.

• The zzzPAT software should be used only on compatible computers that meet the requirements specified in this document.

• Running other programs, commercial or customized, simultaneously with the zzzPAT may interfere with its proper function.

• zzzPAT may not function properly under Windows XP when multiple sessions are running (i.e. when more than one user is logged on to the same PC simultaneously, and each user is running zzzPAT).

• zzzPAT is not supported on Windows XP in remote mode. zzzPAT 4.2