Itamar Medical EndoPAT 2000 User manual

EndoPATTM2000 Device
User Manual
Itamar Medical REF OM1695214
This product and/or method of use, is covered by one or more of the following US patents: 6319205,
6322515, 6461305, 6488633, 6916289, 6939304, 7374540, as well as any pending US patent
applications and corresponding patents and/or applications filed in other countries.
EndoPATTM ,EndoScore™ and PAT™are trademarks of Itamar Medical, Ltd.
Caution: Federal (U.S.) law restricts this
device to sale by, or on the order of, a physician.
Copyright 2002-2015 by Itamar Medical Ltd. Software Version 3.7.x

Itamar Medical Ltd.
EndoPATTM2000 i Operation Manual
This manual and the information contained herein are confidential and are the sole
property of Itamar Medical Ltd. Only Itamar Medical Ltd. or its licensees have the
right to use this information. Any unauthorized use, disclosure or reproduction is a
direct violation of Itamar Medical’s proprietary rights.
THE USE OF THE ENDO PATTM2000 SYSTEM IS GOVERNED BY A
LICENSE AGREEMENT. ANY USE OTHER THAN THAT DESCRIBED IN
SUCH LICENSE AGREEMENT IS PROHIBITED.
DISCLAIMER
Itamar Medical Ltd. shall not be held responsible in any manner for any bodily injury
and/or property damage arising from operation or use of this device other than that
which adheres to the instructions and safety precautions contained herein and in all
supplements hereto and according to the terms of the warranty provided in
Appendix A.
Itamar Medical Ltd.
9 Halamish St., P.O.Box 3579
Caesarea Ind. Park, 3088900, Israel
Tel + 972 4 6177000
Fax + 972 4 6275598
www.itamar-medical.com
ISO 9001:2008 and EN ISO 13485:2012
See appendix B for contact information of the regulatory authorized representative

Itamar Medical Ltd.
EndoPATTM2000 ii Operation Manual
Record of Editions
Edition
Date
Description
Chapter
Pages
0
Jul 02
Preliminary
All
All
1
Oct 02
Base
All
All
2
May 03
Update
All
All
3
Aug 03
Update
All
All
4
Sept 03
Update
All
All
5
Nov 03
Update
All
All
6
May 04
Update following FDA clearance
All
All
7
Dec 04
Update
All
All
8
May 05
Update Appendix A
All
54
9
Jan 07
General update for new S/W version, arm supports and
general overhaul of the manual
All
All
10
May, 07
General update for new S/W version, new USB to COM
driver
All
All
11
June 08
Updating ISO logo, list of standards, Medes address.
Adding of AI note.
All
i, 4, 5,74,77
12
Jan 09
Updating Itamar Medical address.
All
i, 64, 65, 73
13
July 09
General update for new S/W version (3.2.4).
Correction in caution note regarding power supply.
Corrections in installation of adaptor drivers.
Updated patent information.
All
All
14
Jan 10
Probe expiration date
All
56
15
Mar. 10
Update for version 3.3.1
All
6,11,22,33,51
16
Mar. 11
Correcting a omission mistakenly done in older version.
Update CSA symbol
7.2
10.3,10.4
44
56,57
17
Nov. 2011
Change number of tubes in the kit (removal of spare tube)
Updating list of standards
3.1
1.6
9
4-5
18
Feb 12
Updates for version 3.4.4
All
All
19
Feb 13
Updating typo, standards, Labeling
Updating minimum requirements
Updating Moxa driver version
All
All
20
Sep 13
Updating logo of ISO symbol
Updating ED2000 label System +
EndoPATTM2000 Probe Package
-,
10.4
i ,
68 , 69
21
Dec 2013
Updating Endo PAT™report to version 3.5.x
Reordering sub sections and minor rephrasing in chapter 7
(analysis) to improve readability.
OS support update: remove Vista, add Win8
7.4.1
7
3.1, 3.5
10,App D
52
46-61
10,16,
66, 84
22
Jan 2014
Updating zip code
Updating standard table
Update Troubleshooting table
Updating EndoPAT™2000 label System
-, App A
1.6
9
10.4
i , 76
5
64
68
23
March 14
Removing an erroneous restriction entered in version 20
-
Cover page
24
March 14
Adding trade-mark symbols and relevant updated
MEDES address updating
Itamar Medical address updating - zip code, and Ind. Park
All
App B, 10.4
-,10.4
All
70, 78
i, 70
25
May 2014
Insert note
Updating EndoPAT™2000 label System
-,
10.4
ii
68
26
July 2014
Remove wrong quotation marks
Add EndoScore™
Correct Power supplier current
Update temperature ranges, related symbols, probe package
-
7.2,7.4.1,7.7
10.5
10.3-10.5
i
48,50,51,
70
67, 69, 70

Itamar Medical Ltd.
EndoPATTM2000 iii Operation Manual
27
Feb 2015
Updating Caution and Warning symbols
Updating Manufacturing Declarations
Adding spare parts list
Place the device on a stable platform
Tube placement while storing
Warning –advise the use of anti-virus SW and backups
Adding French translation
Updating misspelling
Updating to fit SW version 3.6.x
All
App.E
App.F
3.3
8.1
3.4
1.7, 1.8, 3.4,
6.1.6, 6.2,
6.3.2
All
4.4
5.3
7.4
All
91-94
95
12
63
16
5, 6, 7, 8, 16,
38, 39, 45
All
25-29
34
54
28
July
Updating for version 3.7.x:
Viewer mode, changes in installation and registration, HASP
License troubleshooting
Changes in standby mode
Updating Labeling
Updating Manufacturing Declarations
2,3,4,5.2,
6.2.2,8
9
6.3.1
12.3-12.4
App.E
9,10-11,14-
15,18-
23,25,26,30,31
35,43,68
71
45-47
74-76
98
Note: Latest version of the EndoPAT™User Manual isavailable at:
http://www.itamar-medical.com/Support/Downloads.html

Itamar Medical Ltd.
EndoPATTM2000 iv Operation Manual
Table of Contents
1General Information.............................................................. 1
1.1 Intended Use of the Endo PATTM2000 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: ISO 9001 & ISO 13485 ................................. 4
1.7 Conventions Used in this Manual............................................................ 6
1.8 Safety Precautions.................................................................................. 7
2System Overview................................................................... 9
2.1 How to Use this Manual.......................................................................... 9
3Installing the System............................................................ 10
3.1 Basic System Configuration.................................................................. 10
3.2 System description................................................................................ 11
3.3 Connecting the Endo PATTM2000 device to the Computer..................... 12
3.4 Endo PATTM2000 Software Installation ................................................ 13
3.5 Installing the RS-232 to USB adaptor.................................................... 17
3.6 Registration.......................................................................................... 18
3.7 Uninstalling Endo PATTM2000 Software ............................................... 23
3.8 Shutting Down the System.................................................................... 24
4Software Description ........................................................... 25
4.1 Main Screen ......................................................................................... 25
4.2 Main Screen Menu Commands............................................................. 27
4.3 Main Screen Tool Bar........................................................................... 27
4.4 Configuring the System ........................................................................ 29
4.5 Using the Timer (Countdown Clock) (full application only)................... 34
4.6 Setting the Default Printer.................................................................... 34
5Preparing for a Study .......................................................... 35
5.1 Preparing the System for a Study.......................................................... 35

Itamar Medical Ltd.
EndoPATTM2000 v Operation Manual
5.2 Connecting the PAT™ Probe................................................................ 35
5.3 Creating a Patient File.......................................................................... 36
6Conducting an Endo PATTM2000 Study................................ 41
6.1 Pre-Study............................................................................................. 41
6.2 Patient and System Setup...................................................................... 43
6.3 Performing the Study ........................................................................... 45
7Review and Analysis............................................................ 51
7.1 Study Data Retrieval ............................................................................ 51
7.2 Automatic Analysis............................................................................... 51
7.3 Study Report........................................................................................ 54
7.4 Endo PATTM2000 study results............................................................. 55
7.5 Cardiovascular Risk............................................................................. 57
7.6 Additional / Research Features ............................................................. 58
7.7 Tabular Report .................................................................................... 61
7.8 Batch Analysis...................................................................................... 64
7.9 Manual Analysis (Manual Research Mode only).................................... 64
7.10 Study printing...................................................................................... 67
7.11 Uploading data to the server................................................................. 67
8Maintenance........................................................................ 68
8.1 Device maintenance.............................................................................. 68
8.2 Probe data............................................................................................ 68
9Troubleshooting .................................................................. 69
10 Technical Information ......................................................... 74
10.1 System Minimum Requirements........................................................... 74
10.2 Operating System................................................................................. 74
10.3 Technical information about labeling.................................................... 74
10.4 Labeling............................................................................................... 76
10.5 Specifications for Endo PATTM2000 system........................................... 78

Itamar Medical Ltd.
EndoPATTM2000 vi Operation Manual
Appendix A: License Agreement and Limited Warranty ................. 79
Appendix B: Regulatory Authorized Representative....................... 85
Appendix C: Installing the USB adaptor for Windows XP............... 86
Appendix D: Installing the USB adapter for Windows 7 or 8 ........... 92
APPENDIX E: MANUFACTURING DECLARATIONS
ACCORDING TO IEC 60601-1-2................................................... 98
APPENDIX F: SPARE PARTS LIST............................................ 102
List of Figures
Figure 1 Typical set-up..................................................................................................10
Figure 2 - Endo PATTM2000 device..............................................................................11
Figure 3 - Connection of pneumo-electric tubing and USB adaptor.............................12
Figure 4 - Installshield wizard.......................................................................................14
Figure 5 - License agreement ........................................................................................14
Figure 6 –installation option.........................................................................................15
Figure 7 - Installation folder selection...........................................................................15
Figure 8 –Ready to install the program screen.............................................................16
Figure 9 - Completion of installation ............................................................................16
Figure 10 - Registration reminder and number of left trial recording...........................19
Figure 11 - Registration.................................................................................................19
Figure 12 - Registration Dialog.....................................................................................20
Figure 13 - Registration request file instructions ..........................................................21
Figure 14 Viewer mode registration..............................................................................22
Figure 15 - Registration request file instructions (viewer mode)..................................23
Figure 16 - Main screen.................................................................................................25
Figure 17 –Fill site name dialog box............................................................................26
Figure 18 –Viewer mode registration reminder ...........................................................27
Figure 19 - Gain and time-base scroll boxes.................................................................29
Figure 20 - The setup command....................................................................................30

Itamar Medical Ltd.
EndoPATTM2000 vii Operation Manual
Figure 21 - The setup dialog box (full application and viewer mode) ..........................30
Figure 22 –Report Setup dialog box............................................................................32
Figure 23 - The example for report header....................................................................32
Figure 24 - The PATographer Information dialog box .................................................33
Figure 25 - COM port search.........................................................................................35
Figure 26 - Inserting into slit.........................................................................................36
Figure 27 - Clicking in ..................................................................................................36
Figure 28 - Press to release............................................................................................36
Figure 29 - Probe disconnected.....................................................................................36
Figure 30 - Patient information dialog box (metric version) ........................................37
Figure 31 –“File ID exists” warning message ..............................................................38
Figure 32 –Patient Information –Risk Factors ............................................................40
Figure 33 - Used probes warning ..................................................................................43
Figure 34 - Applying the PAT™ probes .......................................................................44
Figure 35 - Hands set-up ...............................................................................................45
Figure 36 - StandBy mode.............................................................................................46
Figure 37 - Recording....................................................................................................47
Figure 38 - Occlusion quality assessment .....................................................................49
Figure 39 - Open file dialog box ...................................................................................51
Figure 40 - Automatic analysis......................................................................................52
Figure 41 - Occlusion Popup Menu...............................................................................53
Figure 42 –non selective population histograms of RHI..............................................55
Figure 43 - non selective population histograms of LnRHI..........................................56
Figure 44 –LnRHI distribution in non-selective population ........................................56
Figure 45–Historical EndoScore Results –table and chart..........................................57
Figure 46 - AI calculation..............................................................................................59
Figure 47 –AI result from the report (female example) ...............................................60
Figure 48- Time domain HRV in the report..................................................................61
Figure 49- Frequency domain HRV in the report .........................................................61
Figure 50 - Marking Segments and Artifacts ................................................................65
Figure 51 - Probes Information .....................................................................................69
Figure 52 - MOXA USB Installation –XP1 .................................................................86

Itamar Medical Ltd.
EndoPATTM2000 viii Operation Manual
Figure 53 - MOXA USB Installation –XP2 .................................................................87
Figure 54 - MOXA USB Installation –XP3 .................................................................87
Figure 55 - MOXA Adapter ..........................................................................................88
Figure 56 - MOXA Adapter Configuration –XP2........................................................88
Figure 57 - MOXA Adapter Configuration –XP3........................................................89
Figure 58 - MOXA Adapter Configuration –XP4........................................................89
Figure 59 - MOXA Adapter Configuration –XP5........................................................90
Figure 60 - MOXA Adapter Configuration –XP6........................................................90
Figure 61- connect MOXA adaptor...............................................................................91
Figure 62 –connect COM TO COM.............................................................................91
Figure 63 - Win Security...............................................................................................92
Figure 64 - Win7 Security.............................................................................................93
Figure 65 - MOXA Uport driver installation ................................................................93
Figure 66 - MOXA driver installation folder ................................................................94
Figure 67 - MOXA driver folder confirmation .............................................................94
Figure 68 - MOXA driver installation finish.................................................................95
Figure 69 - The MOXA Adapter...................................................................................95
Figure 70- connect MOXA adaptor...............................................................................97
Figure 71 –connect COM TO COM.............................................................................97
List of Tables
Table 1 - Main screen pull down menu commands.......................................................27
Table 2 - Tool bar buttons and functions.......................................................................28
Table 3 –Risk Factors mandatory fields.......................................................................40
Table 4 - Table information...........................................................................................63
Table 5 - Troubleshooting .............................................................................................70
Table 6 - Troubleshooting license.................................................................................72
Table 7 - Error messages...............................................................................................73
Table 8 - Specifications.................................................................................................78

Itamar Medical Ltd.
EndoPATTM2000 Device 1 Operation Manual
1General Information
This manual is part of the EndoPATTM2000 system.
1.1 Intended Use of the EndoPATTM2000 Device
The EndoPATTM2000 device is a non-invasive device, intended for use as a diagnostic aid
in the detection of coronary artery Endothelial Dysfunction (positive or negative) using a
reactive hyperemia procedure.
The Endo PATTM2000 Device has been shown to be predictive of coronary artery
Endothelial Dysfunction in the following patient population: patients with signs or
symptoms of ischemic heart disease, who are indicated for coronary artery angiography, but
who lack angiographic evidence of obstructive coronary artery disease. The device is
intended to be used in a hospital or clinic environment by competent health professionals
The Endo PATTM2000 device is not intended for use as a screening test in the general
patient population. It is intended to supplement, not substitute, the physician’s decision-
making process. It should be used in conjunction with knowledge of the patient’s history
and other clinical findings.
1.2 Performance and clinical study information
The following sensitivity and specificity data were revealed from a clinical study that was
performed at the Mayo Clinic Rochester, MN and that had been designed to evaluate the
safety and effectiveness of the EndoPATTM2000 device as an aiding tool in the diagnosis of
coronary artery Endothelial Dysfunction versus a Gold Standard for coronary Endothelial
Dysfunction evaluation, the Intra-coronary Acetylcholine (Ach) Challenge method:
All subjects: Sensitivity = 82% (45/55), 95% lower confidence bound = 71%
Specificity = 77% (30/39), 95% lower confidence bound = 63%
________________________________________________________________
Females: Sensitivity = 91% (30/33), 95% lower confidence bound = 78%
Specificity = 74% (17/23), 95% lower confidence bound = 55%
Males: Sensitivity = 68% (15/22), 95% lower confidence bound = 48%
Specificity = 81% (13/16), 95% lower confidence bound = 58%
The Gold Standard for Endothelial Dysfunction evaluation, the Intra-coronary
Acetylcholine (Ach) Challenge method, is routinely performed at the Mayo Clinic.
According to the Intra-coronary Acetylcholine (Ach) Challenge method, a catheter is
positioned in the origin of the left main coronary artery and Ach is infused with incremental
concentration followed by coronary angiogram. The coronary artery diameter is measured
in the segment 5mm distal to the tip of a Doppler wire using a computer-based image