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Itamar Medical Ltd.
1.5
Data Generated by the WatchPAT
The WatchPAT generates a PAT respiratory disturbance index ("PRDI"), PAT Apnea-Hypopnea
Index ("PAHI"), PAT central Apnea-Hypopnea Index (pAHIc), percentage of total sleep time with
Cheyne-Stokes Respiration pattern (%CSR) and PAT sleep staging identification ("PSTAGES").
The WatchPAT respiratory indices and sleep stages are estimates of conventional values and
stages identification that are produced by polysomnography ("PSG"). The WatchPAT also
generates acoustic decibel detector used for snoring level and body position discrete states
from the Chest Sensor. The WatchPAT also includes detection of cardiac arrhythmia (Atrial
Fibrillation and Premature Beats) as additional information to its sleep indices.
PRDI and PAHIc are indicated for patients 17 years of age or greater.
NOTES:
The arrhythmia output flags patients suspected of having arrhythmias thereby
aiding the physician to decide if further arrhythmia investigation is needed. The
results, together with patient's anamnesis should be considered when deciding on
further investigation.
1.6
Quality Assurance System: EN ISO 13485
The WatchPAT is compliant to the following standards -
Medical electrical equipment – Part 1: General requirements for
1
basic safety and essential performance
WatchPAT™ONE System
STANDARD
8
IDENTIFICATION
IEC 60601-1:2005 +
CORR.1:2006 + CORR.2:2007 +
AM1:2012
ANSI/AAMI ES60601-1:2005/(R)
2012 and A1:2012, C1:2009/(R)
2012 and A2:2010/(R) 2012
CAN/CSA -C22.2 No.60601-1 :08
+ amendment 1
Operation Manual
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