Itamar Medical Endo PAT x System User manual

1Endo PAT™x Operation Manual
Itamar Medical Ltd.
Endo PAT™x System
Operation Manual for US
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 led in other countries.
EndoPAT™ , EndoScore™ and PAT™ are trademarks of Itamar Medical, Ltd.
Itamar Medical REF OM1695240

Endo PAT™x Operation Manual
Itamar Medical Ltd.
This manual and the information contained here are condential 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 EndoPAT™x 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: License Agreement and Limited Warranty
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
EN ISO 13485:2016
See appendix B for contact information of the regulatory authorized representative

Endo PAT™x Operation Manual
Itamar Medical Ltd.
Record of Editions
Revision Date Description Chapter Pages
1 03 Jan 2022 Initial release similar to OM1695230 Ed.4 EndoPATx
Operation manual draft that has been part of the
EndoPATx K211557 FDA Clearance at 29-Dec-2022
(new part number to differentiate from the CE
cleared OM1695230 Ed.3)
All All
Note: Latest version of the EndoPAT™x Operation Manual isavailable at:
http://www.itamar-medical.com/Support/Downloads.html

Endo PAT™x Operation Manual
Itamar Medical Ltd.
Table of Contents
1 General Information ..............................................................................................1
1.1 Intended Use of the EndoPAT™x Device.................................................................1
1.2 Performance and clinical study information .........................................................1
1.3 Equipment Classication ........................................................................................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 Conguration ..................................................................................11
3.2 System description ................................................................................................12
3.3 Connecting the EndoPAT™x device to the computer......................................... 13
3.4 EndoPAT™x Software Installation........................................................................ 14
3.5 Uninstalling EndoPAT™x Software....................................................................... 16
3.6 Shutting Down the System....................................................................................16
4 EndoPAT™x Application Description ................................................................17
4.1 EndoPAT™x User Roles ..........................................................................................17
4.2 Creating User Roles................................................................................................17
4.3 Operator – Patient Management Screens ............................................................19
4.4 Conducting EndoPAT™x Study – Operator...........................................................27
4.5 Reviewing the EndoPAT™x Study – Doctor (Reviewer) .......................................36
5 Preparing for a Study...........................................................................................43
5.1 Preparing the System for a Study .........................................................................43
5.2 Connecting the PAT™ Probe..................................................................................43

Endo PAT™x Operation Manual
Itamar Medical Ltd.
5.3 Creating/Updating Patient’s Record.....................................................................44
6 Conducting an EndoPAT™x Study......................................................................47
6.1 Pre-Study ................................................................................................................47
6.2 Patient and System Setup .....................................................................................49
6.3 Performing the Study.............................................................................................50
7 Review and Analysis ............................................................................................54
7.1 Study Data Retrieval...............................................................................................54
7.2 Automatic Analysis.................................................................................................54
7.3 Study Report...........................................................................................................55
7.4 EndoPAT™x study results.......................................................................................55
7.5 Study printing.........................................................................................................57
8 Maintenance..........................................................................................................58
8.1 Device maintenance ..............................................................................................58
9 Troubleshooting and System Error Messages ................................................59
9.1 Troubleshooting.....................................................................................................59
9.2 System Error Messages..........................................................................................61
10 Technical Information .........................................................................................62
10.1 System Minimum Requirements...........................................................................62
10.2 Operating System...................................................................................................62
10.3 Technical information about labeling..................................................................62
10.4 Labeling ..................................................................................................................65
10.5 Specications of EndoPAT™x system ...................................................................67
Appendix A: License Agreement and Limited Warranty .............................................68
Appendix B: Regulatory Authorized Representative..................................................69
APPENDIX C: MANUFACTURING DECLARATIONS ACCORDING TO IEC 60601-1-2 ...................70
APPENDIX D: SPARE PARTS LIST ...................................................................................77

Endo PAT™x Operation Manual
Itamar Medical Ltd.
List of Figures
Figure 1 – Typical Setup of EndoPAT™x Study.............................................................11
Figure 2 – EndoPAT™x System ......................................................................................12
Figure 3 - Knob for USB Cable.......................................................................................13
Figure 4 - Login Screen..................................................................................................17
Figure 5 - Local admin pull down menu ......................................................................18
Figure 6 - List of Users ...................................................................................................18
Figure 7- Create User .....................................................................................................18
Figure 8 - Search/Create Patient...................................................................................19
Figure 9 - Selecting Name/ID From List........................................................................20
Figure 10 - Search Button List .......................................................................................20
Figure 11- Add New Patient...........................................................................................20
Figure 12 - New Patient..................................................................................................21
Figure 13 – Patient Record and New Study..................................................................21
Figure 14 - Edit/Update Patient Info.............................................................................22
Figure 15 – Insert Risk Factors-Framingham ...............................................................23
Figure 16 - Insert Risk Factor - Reynolds ......................................................................23
Figure 17 – Insert Risk Factor - European.....................................................................23
Figure 18 - List of Previous Studies...............................................................................24
Figure 19 - Previous Study Options ..............................................................................25
Figure 20 - View Signal Screen......................................................................................25
Figure 21 - Exported EndoPAT™x File ...........................................................................26
Figure 22 - Report File ...................................................................................................26
Figure 23 - CSV File.........................................................................................................26
Figure 24 - Initiating New Test ......................................................................................27
Figure 25 - Open Probs ..................................................................................................27
Figure 26 - New Study Screen .......................................................................................28
Figure 27 - Baseline .......................................................................................................30
Figure 28 - End of Study Comment...............................................................................32

Endo PAT™x Operation Manual
Itamar Medical Ltd.
Figure 29 - Study Screen................................................................................................32
Figure 30 - Error Indicator .............................................................................................34
Figure 31 - Detail of Error...............................................................................................34
Figure 32 - Search Patient- Doctor View.......................................................................36
Figure 33 - Search Button List of Patients....................................................................36
Figure 34 - Patient Record – Doctor View.....................................................................37
Figure 35 – Doctor - Single Study Review Options ......................................................37
Figure 36 - Patient Record – Patient View ....................................................................38
Figure 37 - EndoPAT™x Study Review Main Screen.....................................................39
Figure 38 – Manual Research Mode Analysis and Signal View Screen.......................41
Figure 39 - Print Report Through Browser Menu.........................................................42
Figure 40 - Inserting into slit .........................................................................................43
Figure 41 - Clicking in.....................................................................................................43
Figure 42 - Press to release ...........................................................................................44
Figure 43 - Probe disconnected....................................................................................44
Figure 44 - Applying the PAT™ probes..........................................................................50
Figure 45 - Hands set-up ...............................................................................................50
Figure 46 - Occlusion quality assessment....................................................................53
Figure 47 – non selective population histograms of RHI ............................................56
Figure 48 - non selective population histograms of LnRHI.........................................56
Figure 49 – LnRHI distribution in non-selective population.......................................56
List of Tables
Table 1 – Risk Factors mandatory elds.......................................................................46
Table 2 - Troubleshooting .............................................................................................60
Table 3 - Error messages ...............................................................................................61
Table 4 - Specications .................................................................................................67

1Endo PAT™x Device Operation Manual
Itamar Medical Ltd.
1 General Information
This operation manual is part of the EndoPAT™x system.
1.1 Intended Use of the EndoPAT™x Device
The EndoPAT™x 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 EndoPAT™x 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 EndoPAT™x 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 ndings.
1.21.2 Performance and clinical study informationPerformance and clinical study information
NOTE EndoPAT™x is the successor of EndoPAT™2000, the
currently available device, with the same intended use, same
functionality, and equivalent performance. The information
below is based on EndoPAT™2000 results.
The following sensitivity and specicity 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 condence bound = 71%
Specicity = 77% (30/39), 95% lower condence bound = 63%
________________________________________________________________
Females: Sensitivity = 91% (30/33), 95% lower condence bound = 78%
Specicity = 74% (17/23), 95% lower condence bound = 55%
Males: Sensitivity = 68% (15/22), 95% lower condence bound = 48%
Specicity = 81% (13/16), 95% lower condence bound = 58%

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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 analysis system. Average
peak velocity (APV) is derived from the Doppler ow velocity spectra and coronary blood ow
(CBF) is determined as: π*(coronary artery diameter/2)
2
*(APV/2). Endothelium-dependent
coronary ow reserve is calculated as percent change in CBF in response to the Ach challenge.
Normal coronary endothelial function is dened 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 EndoPATTM2000 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 ow (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 EndoPATTM 2000, which measures Peripheral Arterial Tone
(PATTM) signal changes at the ngertip, to a reactive hyperemia challenge. The PATTM signal is a measure
of the digital pulsatile volume changes and is measured with a non-invasive disposable PATTM probe.
The reactive hyperemia procedure consists of a 3-10 minute baseline recording, 3-5 minutes of blood
ow occlusion to one arm using an lower arm blood pressure cuff, and 3-5 minutes of recording after
cuff release. The expected response is of a post occlusion increase of the PATTM signal amplitude and
the PATTM 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)
Efcacy Analysis Cohort: 94

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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:
• Deformities of ngers that preclude adequate signal acquisition with the
EndoPATTM2000 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.
1.31.3 Equipment ClassicationEquipment Classication
The EndoPAT™x device is classied 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
1.41.4 Manufacturers NoticeManufacturers 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 tness 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.
1.51.5 Restrictions for UseRestrictions for Use
• Only qualied medical personnel may authorize the use of the EndoPAT™x 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 ow occlusion in
botharms. If occlusion is prohibited in only one arm then the reactive hyperemia
procedure that includes the ination of a blood pressure cuff to a supra-systolic
pressure should be performed on the other arm. 
• The EndoPAT™x system in whole, or in part, may not be modied in any way.

4Endo PAT™x Device Operation Manual
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• The device is intended for diagnostic aid purposes only, and should not be used for
monitoring.
• The device is not intended as a screening test in the general patient population.
• The device is not debrillation proof.
• Itamar Medical Ltd. makes no representation whatsoever, that the act of reading
this Operation Manual renders the reader qualied to operate, test or calibrate the
system.
• The tracings and calculations provided by the EndoPAT™x 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 ofce 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).
1.61.6 Quality Assurance System: EN ISO 13485Quality Assurance System: EN ISO 13485
STANDARD #
1. Medical electrical equipment – Part 1:
General requirements for basic safety
and essential performance
EN 60601-1:2006
EN 60601-1:2006/AC:2010
EN 60601-1:2006/A1:2013
IEC 60601-1:2005/A1:2012
[the product was developed
according to IEC 60601-1:2005
+ CORR.1:2006 + CORR.2:2007 +
AM1:2012 (3rd ed+AM1)
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]

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STANDARD #
2. Medical electrical equipment – Part 1-2:
General requirements for basic safety
and essential performance - Collateral
standard: Electromagnetic compatibility
- Requirements and tests
EN 60601-1-2:2015
[the product was developed
according to: IEC 60601-1-2: 2014
(Ed.4)]
3. Medical Device Software – Software Life
Cycle Processes
EN 62304:2006
[the product was developed
according to: IEC 62304: 2006 +
AMD1:2015]
4. Biological evaluation of medical devices
– Part 1: Evaluation and testing within a
risk management process
EN ISO 10993-1: 2009
5. Medical devices. Quality management
systems. Requirements for regulatory
purposes
EN ISO 13485:2016
6. Medical devices. Application of risk
management to medical devices
EN ISO 14971: 2012
7. Medical devices. Symbols to be used
with medical device labels, labelling
and information to be supplied. General
requirements
EN ISO 15223-1:2016
[the product was developed
according to: ISO 15223-1: 2016]
8. Graphical symbols for electrical
equipment in medical practice
IEC/TR 60878: 2015
9. Graphical symbols -- Safety colours and
safety signs -- Registered safety signs;
refer to instruction manual/ booklet
ISO 7010:2019 -M002
10. Information supplied by the manufacture
with medical devices
EN 1041: 2008 + A1:2013
11. Medical Device Directive MDD 93/42 EEC:1993
MDD 2007/47/EC:2007
12. FDA Quality Systems Regulation (QSR) 21 CFR part 820

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STANDARD #
13. Medical electrical equipment - Part 1-6:
General requirements for basic safety
and essential performance - Collateral
standard: Usability
EN 60601-1-6:2010
[the product was developed
according to: IEC 60601-1-6:2010 +
AMD1:2013]
14. Medical devices - Application of usability
engineering to medical devices
EN 62366:2008
[the product was developed
according to: IEC 62366 : 2007 +
AMD1:2014 and IEC 62366-1 : 2015]
15. Directive on the restriction of the use
of certain hazardous substances in
electrical and electronic equipment
RoHS - Directive 2011/65/EU
(RoHS 2)

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1.71.7 Conventions Used in this ManualConventions 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.
CAUTIONS Are used to identify conditions or actions that could cause
interference with data acquisition and/or impair study results.
NOTES Are used to identify an explanation, or to provide additional
information for purposes of clarication.
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 EndoPAT™x device
Operation Manual carefully, before operating the system.
NOTE All pictures, images and screenshots in this operation manual
are for illustrative purposes only and may vary in the actual system.
1.81.8 Safety PrecautionsSafety Precautions
WARNING To avoid the risk of electric shock, this equipment must only
be connected to a separate supply main with protective earth.
Only the power cable that is provided within the EndoPAT™x package
will be used for the system.
Use of an inappropriate cable may cause irreparable damage to
the device and may compromise patient safety or electro-magnetic
compliance.

8Endo PAT™x Device Operation Manual
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WARNING The EndoPAT™x device should only be installed with and
connected to computer equipment that complies with IEC 60950-1 or
IEC 62368-1.
Failure to heed these warnings may compromise patient safety.
WARNING Use of this equipment adjacent to or stacked with other
equipment should be avoided because it could result in improper
operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating
normally.
WARNING Use of accessories, transducers, and cables other than
those specied or provided by the manufacturer of this equipment
could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper
operation.
WARNING Portable RF communications equipment (including
peripherals such as antenna cables and external antennas) should be
used no closer than 30 cm (12 inches) to any part of the EndoPAT™x
device, including cables specied by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
WARNING The device is not intended to be used within the Magnetic
Resonance (MR) environment.

9Endo PAT™x Device Operation Manual
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1. The EndoPAT™x 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 qualied service personnel, authorized by Itamar Medical Ltd.
3. Purchasers of the EndoPAT™x device should ensure that only suitably trained,
qualied 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 EndoPAT™x device Operation Manual should be carefully studied by the
authorized operators and stored where it is easily accessible. Periodic review
of the manual is recommended.
5. The EndoPAT™x 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 EndoPAT™x application.
7. Avoid placing liquids or food on any part of the system. Do not allow
conductive uids to leak into the active circuit components of the system as
this may cause a short circuit, which could result in an electrical re. In this
event, only re extinguishers approved for use on electrical res should be
used.
8. Do not allow uids 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 nger or wounded skin.
12. Do not place any objects or equipment, including laptop computers, on top
of the EndoPAT™x device.

10Endo PAT™x Device Operation Manual
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2 System Overview
The EndoPAT™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 ow 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™x device, is a new type of nger
plethysmograph that imparts a uniform pressure eld to the distal two thirds of the nger
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 reex veno-arteriolar constriction, and it has a higher dynamic range of changes
and better clamping to the nger. Its extended pressure eld also excludes spurious venous
signals while continuously recording the digital arterial pulse wave.
Studies using the EndoPAT™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 can be downloaded 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 nd step-by-step instructions for performing a PAT™ study, and
instructions for maintenance of the system.

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3 Installing the System
3.1 Basic System Conguration
The EndoPAT™x device is
supplied as a complete package
comprising the following
components:
One EndoPAT™x device
One EndoPAT™x software CD
Two pneumo-electric tubing
Power cable
Operation manual
Set of 6 foam nger anchors
USB cable
The supplied EndoPAT™x software package can be used with any Windows™
computer running Windows 10.
For details regarding hardware and software requirements, refer to System
Requirements in Section 10.1.
Although individual system set-ups may vary, Figure 1 – Typical Setup of
EndoPAT™x Study represents a typical setup of a study.
CAUTION The EndoPAT™x device shall be installed on a at surface
with 30cm distance from heat-generating equipment.
Do not place anything on the EndoPAT™x device.
Figure 1 – Typical Setup of EndoPAT™x Study

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3.2 System description
The EndoPAT™x device front panel has the following indicators (see Figure 2 –
EndoPAT™x System):
• POWER LED indicator
• COMM LED indicator for the device-computer communication status
• ERROR LED indicator for error status
• Probes’ Deate and Inate buttons
The following connectors are located on the rear panel (see Figure 2 – EndoPAT™x
System):
• Two pneumatic input connectors for attaching the pneumo-electric tubing,
connecting the PAT™ probes to the EndoPAT™x device
• Power supply AC Inlet connector with ON/OFF switch and fuse drawer
• USB Communication port
Figure 2 – EndoPAT™x System
NOTE The third conductor in the power supply cord functions only as
earthing.
Power LED
Indicator
Communication
LED Indicator
Error LED
Indicator
D-sub
Connectors
USB Type B
connector
Power Inlet
Connector with
fuse drawer and
ON/OFF switch
Deate
Button
Inate
Button

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3.3 Connecting the EndoPAT™x device to the computer
NOTE The EndoPAT™x system requires the use of a USB cable (supplied
with the system) for connecting to the computer.
1. Place the EndoPAT™x device and computer on a stable platform in close
proximity to the examination bed or chair. The device should be placed at
a distance from the bed or chair that is shorter than the pneumo-electric
tubing (less than 1.8 meters/ 6 feet).
NOTE Refer to APPENDIX C: MANUFACTURING DECLARATIONS
ACCORDING TO IEC 60601-1-2 for specic installation instructions for
avoiding electro-magnetic interference between the EndoPAT™x and
other electrical equipment.
2. Connect the USB cable to the communication port on the EndoPAT™x device,
and to one of the computer’s USB ports. Use the strain relief knob on the
EndoPAT™x rear panel for ensuring that the USB cable is not unintentionally
detached from the device ( Figure 3).
3. Connect both pneumo-electric tubing to the EndoPAT™x device’s back panel
pneumo-electric connectors and secure by hand tightening the screws.
4. Make sure the power switch is off. Connect the power supply rst to the
EndoPAT™x device and then to an electrical outlet. Turn the power switch on.
5. The power indicator light will glow, indicating that the power is turned on.
Figure 3 - Knob for USB Cable