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

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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
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4.4
5.3
7.4
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95
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63
16
5, 6, 7, 8, 16,
38, 39, 45
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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
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45-47
74-76
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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

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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

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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

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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

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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

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EndoPATTM2000 Device 2 Operation Manual
analysis system. Average peak velocity (APV) is derived from the Doppler flow velocity
spectra and coronary blood flow (CBF) is determined as: *(coronary artery
diameter/2)2*(APV/2). Endothelium-dependent coronary flow reserve is calculated as
percent change in CBF in response to the Ach challenge.
Normal coronary endothelial function is defined as an increase in CBF of
>50% and an increase or less than 20% decrease in the coronary artery
diameter in response to the maximum dose of intra-coronary Ach (ΔCBF >
50% and ΔCAD > -20%)
[Al Suwaidi J, Hamasaki S, Higano ST, Nishimura RA, Holmes DR Jr, Lerman A. Long-term follow-
up of patients with mild coronary artery disease and endothelial dysfunction. Circulation 101:948-
954, 2000]
Synopsis of Clinical Study Protocol:
Objectives:
To evaluate the Endo PATTM2000 device relative to a gold standard procedure as a
diagnostic aid for detecting coronary endothelial dysfunction.
Methodology:
Patients, who had been referred to diagnostic angiography cardiac catheterization
laboratory for diagnostic angiography secondary to signs or symptoms of ischemic heart
disease and suspected coronary endothelial dysfunction and were found to have normal
or near to normal angiogram, underwent Intra-coronary Acetylcholine (Ach) challenge
test to assess attenuation in required increases to coronary blood flow (CBF) and
coronary artery diameter (CAD), where each of these parameters served as an indicator
for coronary endothelial dysfunction. Coronary endothelial dysfunction is diagnosed if
one of the following changes is observed in response to the Ach challenge test: ΔCBF ≤
50% OR ΔCAD ≤ -20%. Patients were then evaluated using the Endo PAT 2000, which
measures Peripheral Arterial Tone (PAT) signal changes at the fingertip, to a reactive
hyperemia challenge. The PAT signal is a measure of the digital pulsatile volume
changes and is measured with a non-invasive disposable PAT probe. The reactive
hyperemia procedure consists of a 3-10 minute baseline recording, 4.5-5.5 minutes of
blood flow occlusion to one arm using an upper arm blood pressure cuff, and 3-5
minutes of recording after cuff release. The expected response is of a post occlusion
increase of the PAT signal amplitude and the PAT score is provided automatically by
the system’s software and is basically the ratio between the post- to pre- occlusion
average signal size, corrected for systemic changes and baseline level.
Planned Enrollment: 100 patients
Actual Enrollment: 111
Safety Analysis Cohort: 110 (One patient withdrew consent)
Efficacy Analysis Cohort: 94
Criteria for inclusion:
Patient Age > 17
Patient referred to diagnostic angiography
Normal or near normal angiogram (< 30% stenosis)
Evaluation in catheterization laboratory
Signed informed consent
Criteria for exclusion:

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EndoPATTM2000 Device 3 Operation Manual
Deformities of fingers that preclude adequate signal acquisition with the Endo
PATTM2000 device.
Short acting NTG less than 6 hours prior to study and calcium channel blockers
or alpha-blockers less than 24 hours prior to study.
1.3 Equipment Classification
The EndoPATTM2000 device is classified as a Class IIa medical device in accordance with
Rule 10 of Annex IX of the Medical Device Directive 93/42 EEC, 2007/47/EC
According to IEC 60601-1 / UL 60601-1 EndoPATTM2000 device is classified as Class IIa
medical device.
1.4 Manufacturers Notice
The information in this document is subject to change without notice.
Itamar Medical Ltd. makes no warranty of any kind on this material, including but not
limited to, the implied warranties of merchantability and fitness for a particular purpose.
Itamar Medical Ltd. shall not be liable for errors contained herein or for incidental or
consequential damages in connection with the furnishing, performance, or use of this
material.
This document contains proprietary information, which is protected by copyright. All rights
reserved. No part of this document may be photocopied, reproduced, or translated without
the prior written consent of Itamar Medical Ltd.
1.5 Restrictions for Use
Only qualified medical personnel may authorize the use of the EndoPATTM2000
device.
In the event of equipment malfunction all repairs should be executed by authorized
Itamar Medical Ltd. personnel or licensed service agents.
The eligibility of a patient for a PAT™study is generally based upon the patient’s
medical status. The following should not be considered for the PAT™study:
Deformities of the digits of the upper extremities, which preclude
adequate signal acquisition
Patients under the effect of short-acting NTG (3 hours washout
period)
Patient suffering from a medical condition prohibiting blood flow
occlusion in both arms. If occlusion is prohibited in only one arm
then the reactive hyperemia procedure that includes the inflation of
a blood pressure cuff to a supra-systolic pressure should be
performed on the other arm.
The EndoPATTM2000 system in whole, or in part, may not be modified in any way.

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EndoPATTM2000 Device 4 Operation Manual
The device is intended for diagnostic purposes only, and should not be used for
monitoring.
The device is not intended as a screening test in the general patient population.
Itamar Medical Ltd. makes no representation whatsoever, that the act of reading this
User Manual renders the reader qualified to operate, test or calibrate the system.
The tracings and calculations provided by the EndoPATTM2000 system are intended
as tools for the competent diagnostician. They are explicitly not to be regarded as a
sole incontrovertible basis for clinical diagnosis.
In the event that the system does not operate properly, or if it fails to respond to the
controls in the manner described in this manual, the operator should refer to the
Troubleshooting section. If necessary, contact our service office to report the
incident, and to receive further instructions (customer support can be reached at
[phone] ext. 399, or from the US: [phone] ext. 399).
1.6 Quality Assurance System: ISO 9001 & ISO 13485
STANDARD
#
1.
Medical electrical equipment –Part 1: General requirements
for basic safety and essential performance
IEC 60601-1
2.
Medical electrical equipment –Part 1-2: General requirements
for basic safety and essential performance - Collateral
standard: Electromagnetic compatibility - Requirements and
tests
IEC 60601-1-2
3.
Medical electrical equipment - Part 1-4: General requirements
for safety –Collateral Standard: Programmable electrical
medical systems
IEC 60601-1-4
4.
Medical Device Software –Software Life Cycle Processes
IEC 62304
5.
Quality management systems - requirements
ISO 9001:2008
6.
Medical devices. Quality management systems. Requirements
for regulatory purposes
EN ISO 13485:2012
7.
Medical devices - Quality management systems -
Requirements for regulatory purposes (Health Canada)
CAN/CSA ISO
13485:2003
8.
Medical devices. Application of risk management to medical
devices
ISO 14971

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EndoPATTM2000 Device 5 Operation Manual
9.
Medical devices. Symbols to be used with medical device
labels, labelling and information to be supplied. General
requirements
ISO 15223-1
10.
Graphical symbols for electrical equipment in medical
practice
IEC TR 60878
11.
Graphical symbols -- Safety colours and safety signs --
Registered safety signs; refer to instruction manual/ booklet
ISO 7010-M002
12.
Information supplied by the manufacture with medical devices
EN 1041
13.
Medical Device Directive
MDD 93/42 EEC
MDD 2007/47/EC
14.
FDA Quality Systems Regulation (QSR)
21 CFR part 820
15.
CSA standard for safety
CSA 22.2 No. 601.1
16.
UL standard for safety
UL 60601-1
17.
Canadian Medical Devices Regulations
SOR/98-282
18.
Medical devices - Application of usability engineering to
medical devices
BS EN 62366

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EndoPATTM2000 Device 6 Operation Manual
1.7 Conventions Used in this Manual
The following conventions are used throughout this manual:
Warnings
Are used to identify conditions or actions, which - if the
instructions are ignored - may violate patient safety, or could
cause damage/malfunction of the system, resulting in the
irretrievable loss of data.
Avertissements
Ils sont destinés à cerner les conditions ou les actions qui –au
cas de non observation des instructions –risqueraient de
mettre en péril la sécurité du patient ou affecter le bon
fonctionnement du système et aboutir à une perte irréversible
de données.
Cautions
Are used to identify conditions or actions that could cause
interference with data acquisition and/or impair study results.
Précautions
Elles sont destinées à cerner les conditions ou les actions qui
risquent d'entraver l'acquisition de données et compromettre
les résultats de l'examen.
Notes
Are used to identify an explanation, or to provide additional
information for purposes of clarification.
Notes
Elles sont destinées à repérer une explication ou fournir une
explication supplémentaire en vue de clarification.
There are no additional warnings and cautions, other than those provided in the appropriate
sections of this manual.
Physicians, nurses, and medical technicians should read the Endo PATTM2000 device
Operation Manual carefully, before operating the system.
All pictures are for illustrative purposes only.

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EndoPATTM2000 Device 7 Operation Manual
1.8 Safety Precautions
WARNING
Only the power supply that is provided within the EndoPATTM2000
package will be used for the system.
Use of an inappropriate adapter may cause irreparable damage to
the device and may compromise patient safety.
Avertissement
L'appareil sera alimenté uniquement à l'aide du boitier électrique
inclus dans le kit EndoPATTM2000.
L'usage d'un adaptateur non approprié risque de provoquer des
dégâts irréparables de l'appareil et de porter atteinte à la sécurité du
patient.
WARNING
The Endo PATTM2000 device should only be installed with and
connected to computer equipment that complies with EN60950
safety regulations.
Failure to heed these warnings may compromise patient safety.
Avertissement
L'appareil EndoPATTM2000 doit être installé et connecté
uniquement à un ordinateur qui répond aux normes de sécurité
EN60950.
La non observation de cet avertissement risque de porter atteinte à
la sécurité de patient.
1. The EndoPATTM2000 device has been designed and manufactured to meet all safety
requirements applicable to medical equipment. To ensure maximum operation safety
the system should be used and maintained in strict compliance with the safety
precautions, warnings and operating instructions provided in this manual.
2. The system contains no user-serviceable parts. It should be maintained and serviced
only by qualified service personnel, authorized by Itamar Medical Ltd.
3. Purchasers of the Endo PATTM2000 device should ensure that only suitably trained,
qualified personnel are authorized to operate the equipment. Unauthorized personnel
should not be allowed access to the system. It is recommended that a list of
authorized operators be maintained.
4. The EndoPATTM2000 device Operation Manual should be carefully studied by the

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EndoPATTM2000 Device 8 Operation Manual
authorized operators, and stored where it is easily accessible. Periodic review of the
manual is recommended.
5. The EndoPATTM2000 system is a whole system. To eliminate risk of electrical shock,
do not attempt to open or remove system covers or plugs.
6. Do not operate or activate mobile phones, or other devices capable of causing electro-
magnetic interference, nearby the system. Turn off wireless communication in the
computer running the EndoPATTM2000 application.
7. Avoid placing liquids or food on any part of the system. Do not allow conductive
fluids to leak into the active circuit components of the system as this may cause a
short circuit, which could result in an electrical fire. In this event, only fire
extinguishers approved for use on electrical fires should be used.
8. Do not allow fluids to come in contact with the pneumatic connection in the device.
9. Do not operate the equipment in the presence of explosive liquids, vapors or gases.
10. In the event that the system does not operate properly, or if it fails to respond to the
controls in the manner described in this manual, the operator should contact customer
support.
11. Do not apply the probe to an infected finger or wounded skin.
Caution
Federal law restricts this device to sale by or on the order of a
physician.
Précaution
Selon la loi fédérale, la vente de cet appareil ne s'effectue que par
ou sous ordre d’un médecin.

Itamar Medical Ltd.
EndoPATTM2000 Device 9 Operation Manual
2System Overview
The Endo PATTM2000 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 Endo PATTM2000 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 EndoPATTM2000 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 (full application or viewer version)
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.
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.

Itamar Medical Ltd.
EndoPATTM2000 Device 10 Operation Manual
3Installing the System
3.1 Basic System Configuration
The EndoPATTM2000 device is supplied as a complete package comprising the following
components:
One EndoPATTM2000 device
One EndoPATTM2000 software CD
One HASP (dongle) required for full application only
Two pneumo-electric
tubing
Power adaptor
Power cable
Operation manual
Set of 6 foam finger
anchors
USB adaptor
The supplied EndoPATTM2000
software package can be used with
any Windows computer running
English versions of Windows XP
Windows 7 or Windows 8. The
automatic analysis module requires any type of internet browser or Excel 2000 or newer.
For details regarding hardware and software requirements, refer to System Requirements in
Section 10.1.
Although individual system set-ups may vary, Figure 1 represents a typical setup of a study.
NOTE
The EndoPATTM2000 Software has 2 installation options:
The full application is required when working with the device and
recording data. This option requires a HASP (dongle) to be
connected and software activation.
The viewer mode allows viewing recorded studies and analysis.
This mode doesn’t require a HASP.
Figure 1 Typical set-up

Itamar Medical Ltd.
EndoPATTM2000 Device 11 Operation Manual
3.2 System description
The EndoPATTM2000 device top panel has:
Power LED indicator
LED indicator for the device-computer communication status
Probe’s Deflate and Inflate buttons
Figure 2 - EndoPATTM2000 device
The front panel has two pneumatic input connectors for attaching the pneumo-electric
tubing, connecting the PAT™probes to the EndoPATTM2000 device.
The back panel has (Figure 2):
Power supply DC connector
Communication port
ON/OFF switch
Deflate Button
Inflate Button
Power LED
Indicator
Communication
LED Indicator
Power Supply
DC Connector
USB-to-COM
adaptor
ON/OFF Switch