Itamar Medical EndoPAT Series User manual

Endo PAT
TM
x System
Operation Manual
Itamar Medical REF OM1695230
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.
EndoPAT
TM
, EndoScore™ and PAT™ are trademarks of Itamar Medical, Ltd.
Copyright  2019-2020 by Itamar Medical Ltd.

Itamar Medical Ltd.
Endo PAT
TM
x i Operation Manual
This manual and the information contained here 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 ENDOPAT
TM
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

Itamar Medical Ltd.
Endo PATTMx ii Operation Manual
Record of Editions
Note: Latest version of the EndoPAT™x Operation Manual is available at:
http://www.itamar-medical.com/Support/Downloads.html
Edition Date Description Chapter Pages
1
26 Aug 2019
Initial release
All
All
2 28 Dec 2020 Updated Standards
Updated installation
Updated screenshots
Safety Precautions
License agreement link
Room temperature range
Label
Label
1.6
3.4
4
1.8
Appendix A
10.5
10.4.1
10.4.4
10-12
20-21
23-42
14
72
71
69
70

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

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Endo PATTMx iv Operation Manual
6 Conducting an EndoPATTMx 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 EndoPATTMx study results ........................................................................... 55
7.5 Cardiovascular Risk ...................................................................................... 57
7.6 Additional / Research Features .................................................................... 59
7.7 Study printing ................................................................................................ 62
8 Maintenance ................................................................................. 63
8.1 Device maintenance ....................................................................................... 63
9 Troubleshooting ........................................................................... 64
9.1 System Error Messages ................................................................................. 66
10 Technical Information ................................................................. 67
10.1 System Minimum Requirements .................................................................. 67
10.2 Operating System .......................................................................................... 67
10.3 Technical information about labeling ......................................................... 67
10.4 Labeling ......................................................................................................... 69
10.5 Specifications of EndoPATTMx system ........................................................ 71
Appendix A: License Agreement and Limited Warranty .................... 72
Appendix B: Regulatory Authorized Representative .......................... 73
APPENDIX C: MANUFACTURING DECLARATIONS
ACCORDING TO IEC 60601-1-2 .......................................................... 74
APPENDIX D: SPARE PARTS LIST ................................................... 81

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Endo PATTMx v Operation Manual
List of Figures
Figure 1 Typical set-up .................................................................................................. 11
Figure 2 – EndoPAT™x System ................................................................................... 12
Figure 3 - EndoPAT Study Main Screen ....................... Error! Bookmark not defined.
Figure 4 - Warning and Error Indications ..................... Error! Bookmark not defined.
Figure 5 - Patient Record – Doctor View ...................................................................... 37
Figure 6 - Patient Record – Patient View ...................................................................... 38
Figure 7 - EndoPATx Study Review Main Screen ....................................................... 39
Figure 8 - Inserting into slit ........................................................................................... 43
Figure 9 - Clicking in .................................................................................................... 43
Figure 10 - Press to release ............................................................................................ 44
Figure 11 - Probe disconnected ..................................................................................... 44
Figure 12 - Applying the PAT™ probes ....................................................................... 50
Figure 13 - Hands set-up ............................................................................................... 50
Figure 14 - Occlusion quality assessment ..................................................................... 53
Figure 16 – non selective population histograms of RHI .............................................. 56
Figure 17 - non selective population histograms of LnRHI .......................................... 56
Figure 18 – LnRHI distribution in non-selective population ........................................ 57
Figure 19 - AI calculation .............................................................................................. 60
Figure 20 – AI result from the report (female example) ............................................... 60
Figure 21- Time domain HRV in the report .................................................................. 61
Figure 22- Frequency domain HRV in the report ......................................................... 61
List of Tables
Table 1 – Risk Factors mandatory fields ....................................................................... 46
Table 2 - Troubleshooting ............................................................................................. 65
Table 3 - Error messages ............................................................................................... 66
Table 4 - Specifications ................................................................................................. 71

Itamar Medical Ltd.
Endo PATTMx Device 1 Operation Manual
1 General Information
This operation manual is part of the EndoPATTMx system.
1.1 Intended Use of the EndoPATTMx Device
The EndoPATTMx 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 EndoPATTMx 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 EndoPATTMx 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
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 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%

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Endo PATTMx Device 2 Operation Manual
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 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 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 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 EndoPAT 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, 3-5 minutes of blood flow 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 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

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Endo PATTMx Device 3 Operation Manual
 Patient referred to diagnostic angiography
 Normal or near normal angiogram (< 30% stenosis)
 Evaluation in catheterization laboratory
 Signed informed consent
Criteria for exclusion:
 Deformities of fingers 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.
1.3 Equipment Classification
The EndoPATTMx 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
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 EndoPATTMx 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 EndoPATTMx system in whole, or in part, may not be modified in any way.
 The device is intended for diagnostic aid purposes only, and should not be used for

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Endo PATTMx Device 4 Operation Manual
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
Operation Manual renders the reader qualified to operate, test or calibrate the
system.
 The tracings and calculations provided by the EndoPATTMx 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: 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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Endo PATTMx Device 5 Operation Manual
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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Endo PATTMx Device 6 Operation Manual
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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Endo PATTMx Device 7 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.
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 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 EndoPATTMx 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.
1.8 Safety 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 EndoPATTMx
package will be used for the system.

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Endo PATTMx Device 8 Operation Manual
Use of an inappropriate cable may cause irreparable damage to the
device and may compromise patient safety or electro-magnetic
compliance.
WARNING
The EndoPATTMx 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 specified
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 specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
1. The EndoPATTMx device has been designed and manufactured to meet all safety

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Endo PATTMx Device 9 Operation Manual
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 EndoPATTMx 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 EndoPATTMx 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 EndoPATTMx 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 EndoPATTMx 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.
12. Do not place any objects or equipment, including laptop computers, on top of the
EndoPATx device.

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Endo PATTMx Device 10 Operation Manual
2 System Overview
The EndoPATTMx 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 EndoPATTMx 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 EndoPATTMx device are easily performed in any clinical setting, with a
minimal period of training required. The system is fully computerized and the recorded
signals are simultaneously displayed on a PC or laptop screen. Recorded data is automatically
saved, facilitating subsequent review and computerized automatic analysis. Due to the fact
that analysis is performed automatically, there is no question of inter or intra operator
interpretation variability.
The PAT™ software program is easy to use and has two main operating modes:
 Real time recording and display
 Off-line display and analysis
Since the system records data in real time, it is possible to follow events as they occur.
Data acquired during a study is automatically stored to the computer’s hard disk and may
subsequently be retrieved for off-line review and automatic analysis.
EndoPAT™x is the successor of EndoPAT™2000, the currently available device, with the
same intended use, same functionality and equivalent performance.
2.1 How to Use this Manual
This Operation Manual is designed as a general guide to help the user in operating the system.
The user will find step-by-step instructions for performing a PAT™ study, and instructions
for maintenance of the system.

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Endo PATTMx Device 11 Operation Manual
3 Installing the System
3.1 Basic System Configuration
The EndoPATTMx device is supplied as a complete package comprising the following
components:
 One EndoPATTMx device
 One EndoPATTMx software CD
 Two pneumo-electric tubing
 Power cable
 Operation manual
 Set of 6 foam finger anchors
 USB cable
The supplied EndoPAT™x software package can be used with any Windows™ computer
running English versions of 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 represents a typical setup of a study.
Caution
The EndoPATx device shall be installed on a flat surface with
30cm distance from heat-generating equipment.
Do not place anything on the EndoPATx device.
Figure 1 Typical set-up

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Endo PATTMx Device 12 Operation Manual
3.2 System description
The EndoPATTMx 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’ Deflate and Inflate 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 EndoPATTMx 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.
Inflate Button
Deflate Button
Power LED
Indicator
Communication
LED Indicator
Power Inlet
Connector with
fuse drawer and
ON/OFF
switch
USB Type B
connector
Error LED
Indicator
D
-
sub Connectors

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Endo PATTMx Device 13 Operation Manual
3.3 Connecting the EndoPATTMx device to the Computer
1. Place the EndoPATTMx 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 specific installation instructions for
avoiding electro-magnetic interference between the EndoPATx and other
electrical equipment.
2. Connect the USB cable to the communication port on the EndoPATTMx device, and to
one of the computer’s USB port. Use the strain relief knob on the EndoPATx 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 EndoPATTMx 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 first to the EndoPATTMx
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
NOTE
The EndoPATTMx system requires the use of a USB cable (supplied with
the system) for connecting to the computer.

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3.4 EndoPATTMx Software Installation
NOTE
Prior to software installation, verify that you are in full system
administrator mode with full privileges. Otherwise, the installation might
not succeed and could cause operational problems.
1. Close all open applications operating on the computer, including background
applications, before installing the EndoPATTMx software.
NOTE
Uninstall previous EndoPATTMx software versions prior to installing a
newer version. To uninstall the software please refer to section 3.5.
Make sure to backup all your patient data and system configuration prior
to uninstalling any software.
2. Insert the EndoPATTMx software CD into the CD drive. The installation program
will load automatically. Alternatively you may execute the Itamar-Installer'
application from the installation CD.
3. The install wizard prepares the computer for installation. When prompted, click
next to proceed with the installation.
4. Click “Next” to set the default target folder for software installation, or click
“Change” to select a different folder for the installation.
NOTE
It is not recommended to install the program in the “My Documents” or
“Desktop” folders.
5. Press “Install Now” to complete the installation process or “Back” to review or
change any of your installation settings.
6. Press “continue” when installation is permission is requested.
7. Press “Next” when the EntoPAT2000 installation wizard is opened
8. Sign “Accept” and “Next” on License Agreement the “Next” and “Install”