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Itamar Medical Ltd.
Endo
PAT
TM
x Device
10
Operation Manual
2
System Overview
The EndoPAT
TM
x device is a computer-based system for non-invasively assessing vascular
endothelial dysfunction. It is based on the use of Peripheral Arterial Tone (PAT
™
) signal
technology, during a clinically established procedure, which measures post-ischemic
vascular responsiveness following upper arm blood flow occlusion.
PAT
™
signal technology is a newly developed proprietary technology for measuring the
magnitude and dynamics of arterial tone changes in peripheral arterial beds. PAT™
technology measures peripheral arterial tone, by recording digital pulsatile volume changes
without involving painful and risky invasive procedures.
The non-invasive PAT™ probe, used with the EndoPAT
TM
x device, is a new type of finger
plethysmograph that imparts a uniform pressure field to the distal two thirds of the finger
including its tip. It was designed to avoid many of the existing problems associated with
conventional plethysmographic devices such as distal venous distention and the resulting
induction of reflex veno-arteriolar constriction, and it has a higher dynamic range of changes
and better clamping to the finger. Its extended pressure field also excludes spurious venous
signals while continuously recording the digital arterial pulse wave.
Studies using the EndoPAT
TM
x device are easily performed in any clinical setting, with a
minimal period of training required. The system is fully computerized and the recorded
signals are simultaneously displayed on a PC or laptop screen. Recorded data is automatically
saved, facilitating subsequent review and computerized automatic analysis. Due to the fact
that analysis is performed automatically, there is no question of inter or intra operator
interpretation variability.
The PAT™ software program is easy to use and has two main operating modes:
Real time recording and display
Off-line display and analysis
Since the system records data in real time, it is possible to follow events as they occur.
Data acquired during a study is automatically stored to the computer’s hard disk and may
subsequently be retrieved for off-line review and automatic analysis.
EndoPAT™x is the successor of EndoPAT™2000, the currently available device, with the
same intended use, same functionality and equivalent performance.
2.1
How to Use this Manual
This Operation Manual is designed as a general guide to help the user in operating the system.
The user will find step-by-step instructions for performing a PAT™ study, and instructions
for maintenance of the system.