WatchPAT™300 System
1
Operation Manual
1 GENERAL INFORMATION
This manual is part of the WatchPAT™300 system.
1.1
Intended Use / Indications for Use
The WatchPAT™300 (WP300) device is a non-invasive home care device for use with
patients suspected to have sleep related breathing disorders. The WP300 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
WP300 generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index
("PRDI"), Apnea-Hypopnea index ("PAHI"), Central Apnea-Hypopnea index ("PAHIc"),
PAT sleep staging identification (PSTAGES) and optional snoring level and body position
discrete states from an external integrated snoring and body position sensor. The WP300's
PSTAGES and snoring level and body position provide supplemental information to its
PRDI/PAHI/PAHIc. The WP300's PSTAGES and snoring level and body position 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.
PAHIc is indicated for use in patients 17 years and older. All other parameters are indicated
for 12 years and older.
1.2
Restrictions for Use
1.
The WP300 should be used only in accordance with physician’s instructions. For
exclusion criteria see Section 1.3.
2.
Only qualified medical personnel may authorize the use of the WP300.
3.
Qualified medical personnel must instruct the patients (and accompanying
individual if needed) how to attach and use the WP300 prior to use.
4.
In the event of equipment malfunction all repairs should be executed by authorized
Itamar Medical Ltd. personnel or licensed service agents.
5.
The eligibility of a patient for a PAT
®
study is entirely at the discretion of a
physician, and is generally based upon the patient’s medical status.
6.
The WP300 system in whole, or in part, may not be modified in any way.
7.
The WP300 is used as an aid for diagnostic purposes only, and should not be used
for monitoring.
8.
Only suitably trained and qualified personnel should be authorized to prepare the
WP300 equipment prior to use.
9.
The WP300 Operation Manual should be carefully studied by the authorized
operators, and kept where it is easily accessible. Periodic review of the Manual is
recommended.
10.
Itamar Medical Ltd. makes no representation whatsoever, that the act of reading the
Manual renders the reader qualified to operate, test or calibrate the system.
