Itamar Medical EndoPAT 2000, Operation Manual

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Itamar Medical Ltd.
Endo PAT
TM
x iii Operation Manual
Table of Contents
1 General Information ...................................................................... 1
1.1 Intended Use of the EndoPAT TM x Device ..................................................... 1
1.2 Performance and clinical study information ................................................ 1
1.3 Equipment Classification ................................................................................ 3
1.4 Manufacturers Notice ..................................................................................... 3
1.5 Restrictions for Use ......................................................................................... 3
1.6 Quality Assurance System: EN ISO 13485 ................................................... 4
1.7 Conventions Used in this Manual .................................................................. 7
1.8 Safety Precautions ........................................................................................... 7
2 System Overview .......................................................................... 10
2.1 How to Use this Manual ................................................................................ 10
3 Installing the System .................................................................... 11
3.1 Basic System Configuration ......................................................................... 11
3.2 System description ......................................................................................... 12
3.3 Connecting the EndoPAT TM x device to the Computer .............................. 13
3.4 EndoPAT
TM
x Software Installation ............................................................. 14
3.5 Uninstalling EndoPAT
TM
x Software ........................................................... 15
3.6 Shutting Down the System ............................................................................ 16
4 EndoPATx Application Description ........................................... 17
4.1 EndoPATx User Roles................................................................................... 17
4.2 Login Screen .................................................................................................. 17
4.3 Search for Patient Screen - Operator .......................................................... 18
4.4 Conducting EndoPATx Study - Operator................................................... 26
4.5 Reviewing the EndoPATx Study - Reviewer .............................................. 36
5 Preparing for a Study .................................................................. 43
5.1 Preparing the System for a Study ................................................................ 43
5.2 Connecting the PAT™ Probe ....................................................................... 43
5.3 Creating/Updating Patient’s Record ........................................................... 44