WatchPAT™200 System
1
Operation Manual
1
GENERAL INFORMATION
This manual is part of the WatchPAT™200 system.
1.1 Intended use / Indications for Use
The WatchPAT™200 (WP200) device is a non-invasive home care device for use with
patients suspected to have sleep related breathing disorders. The WP200 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 WP200 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 WP200’s
PSTAGES and SBP provide supplemental information to its PRDI/PAHI. The
WP200’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 WatchPAT™200 device is not indicated for children less than 17 years old.
1.2 Restrictions for Use
1.
The WP200 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 WP200.
3.
Qualified medical personnel must instruct the patients how to attach and use the
WP200 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 WP200 system in whole, or in part, may not be modified in any way.
7.
The WP200 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
WP200 equipment prior to use.
9.
The WP200 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.
11.
The tracings and calculations provided by the WP200 system are intended as tools
for the competent diagnostician. They are explicitly not to be regarded as a sole
incontrovertible basis for clinical diagnosis.
