Itamar Medical EndoPATx System Operation Manual
  1. Manuals
  2. Brands
  3. Itamar Medical Manuals
  4. Medical Equipment
  5. Endo PAT x System
  6. Operation manual

Itamar Medical EndoPATx System Operation Manual

Hide thumbs Also See for EndoPATx System:
Table of Contents

Advertisement

Quick Links

Download this 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  2019-2024 by Itamar Medical Ltd.

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the EndoPATx System and is the answer not in the manual?

Questions and answers

Related Manuals for Itamar Medical EndoPATx System

Summary of Contents for Itamar Medical EndoPATx System

  • Page 1 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 , EndoScore™ and PAT™ are trademarks of Itamar Medical, Ltd. Copyright  2019-2024 by Itamar Medical Ltd.
  • Page 3 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...
  • Page 4 Itamar Medical Ltd. Itamar Medical Ltd. Itamar Medical Ltd. Record of Revisions Record of Revisions Record of Revisions Revision Revision Date Date Description Description Chapter Chapter Pages Pages Revision Date Description Chapter Pages 26 Aug 2019 26 Aug 2019 Initial release...

  • Page 5: Table Of Contents

    Itamar Medical Ltd. Table of Contents General Information ............. 1 Intended Use of the EndoPAT x Device ..........1 Performance and clinical study information ........... 1 Equipment Classification ............... 3 Manufacturers Notice ................3 Restrictions for Use ................3 Quality Assurance System: EN ISO 13485..........4 Conventions Used in this Manual ............
  • Page 6 Itamar Medical Ltd. Conducting an EndoPAT x Study ........46 Pre-Study .................... 46 Patient and System Setup..............48 Performing the Study ................50 Review and Analysis ............53 Study Data Retrieval ................53 Automatic Analysis ................53 Study Report ..................54 EndoPAT x study results ..............
  • Page 7 Itamar Medical Ltd. List of Figures Figure 1 – Typical Setup of EndoPAT™x Study ............10 Figure 2 – EndoPAT™x System ................... 11 Figure 3 - Knob for USB Cable ..................12 Figure 4 - Login Screen ....................16 Figure 5 - Local admin pull down menu ............... 17 Figure 6 - List of Users ....................
  • Page 8 Itamar Medical Ltd. Figure 32 - Search Patient ..................... 35 Figure 33 - Search Button List of Patients ..............35 Figure 34 - Patient Record – Doctor View ..............36 Figure 35 – Patient Record – Doctor View: Single Study Review Options ....36 Figure 36 - Patient Record –...

  • Page 9: General Information

    Itamar Medical Ltd. 1 General Information This operation manual is part of the EndoPAT x system. 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.
  • Page 10 Itamar Medical Ltd. 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.

  • Page 11: Equipment Classification

    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.

  • Page 12: Quality Assurance System: En Iso 13485

    The device is intended for diagnostic aid purposes only and should not be used for • Itamar Medical Ltd. makes no representation whatsoever, that the act of reading this Itamar Medical Ltd. makes no representation whatsoever, that the act of reading this monitoring.
  • Page 13 Itamar Medical Ltd. Itamar Medical Ltd. Itamar Medical Ltd. STANDARD STANDARD STANDARD Graphical symbols for electrical equipment in medical IEC/TR 60878 Graphical symbols for electrical equipment in medical Graphical symbols for electrical equipment in medical IEC/TR 60878 IEC/TR 60878 practice...

  • Page 14: Conventions Used In This Manual

    Itamar Medical Ltd. 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.
  • Page 15 Itamar Medical Ltd. Use of an inappropriate cable may cause irreparable damage to the device and may compromise patient safety or electro-magnetic compliance. 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.
  • Page 16 The system contains no user-serviceable parts. It should be maintained and serviced only by qualified service personnel, authorized by Itamar Medical Ltd. Purchasers of the EndoPAT x device should ensure that only suitably trained, qualified personnel are authorized to operate the equipment.

  • Page 17: System Overview

    Itamar Medical Ltd. 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 flow occlusion.

  • Page 18: Installing The System

    Itamar Medical Ltd. Itamar Medical Ltd. 3 Installing the System 3 Installing the System Basic System Configuration Basic System Configuration The EndoPAT x device is supplied as a The EndoPAT x device is supplied as a complete package comprising the following...

  • Page 19: System Description

    Itamar Medical Ltd. Itamar Medical Ltd. System description System description The EndoPAT The EndoPAT x device front panel has the following indicators (see Figure 2 – x device front panel has the following indicators (see Figure 2 – Itamar Medical Ltd.

  • Page 20: Connecting The Endopat Tm X Device To The Computer

    Itamar Medical Ltd. 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.

  • Page 21: Endopat Tm X Software Installation

    Itamar Medical Ltd. EndoPAT x 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 EndoPAT x software.
  • Page 22 Itamar Medical Ltd. 9. When screen appears press “No” (don’t confirm restart!) 10. When the below screen appears click on “Summary” 11. Then you should see “Itamar EPx was successfully installed” 12. Click on the small arrow on the right corner and choose “Quit”...

  • Page 23: Uninstalling Endopat Tm X Software

    Itamar Medical Ltd. Uninstalling EndoPAT x Software Use the EndoPAT x install wizard to uninstall the application from your PC. Shutting Down the System a. Shut down the EndoPAT x software program by clicking on the “X” on the upper right corner.

  • Page 24: Endopat Tm X Application Description

    Itamar Medical Ltd. 4 EndoPAT x Application Description The following screens describe the full application. Viewer mode has the relevant subset of the controls (the title of the screen might be different). EndoPAT x User Roles There are three user roles for the EndoPAT...

  • Page 25: Figure 5 - Local Admin Pull Down Menu

    Itamar Medical Ltd. Once logged in as Local Admin press on the arrow on upper right side of the screen. A pull- down menu will open with optional tasks (Figure 5 - Local admin pull down menu). Figure 5 - Local admin pull down menu Select Users, a list of existing users will appear and an option to Create Users.

  • Page 26: Operator - Patient Management Screens

    Itamar Medical Ltd. NOTE The system does not send an automatic email to the user, the Local Admin should provide the name and password to each user created. Operator – Patient Management Screens 4.3.1 Search for an existing patient Figure 8 - Search/Create Patient Enter the patient’s name or identifier (ID).

  • Page 27: Figure 9 - Selecting Name/Id From List

    Itamar Medical Ltd. Figure 9 - Selecting Name/ID From List Figure 10 - Search Button List Selecting a patient either from the drop-down list or Search results opens the Patient Record. 4.3.2 Add New Patient To add a new Patient, click on the “+ Add new patient” button.

  • Page 28: Figure 12 - New Patient

    Itamar Medical Ltd. Figure 12 - New Patient When form is filled, click “Save and Continue” button to open Patient Record screen. 4.3.3 Patient Record Screen - Operator The Patient Record Screen displays the personal details and risk factors (optional). In addition, Previous Test Records can be accessed through this link.

  • Page 29: Figure 14 - Edit/Update Patient Info

    Itamar Medical Ltd. 4.3.3.1 Update/Edit Patient details. Clicking on UPDATE on the personal details sections opens the following pop-up window. Click Apply to update the details and return to the Patient Records screen. Figure 14 - Edit/Update Patient Info. Note Patient ID cannot be modified and updated.

  • Page 30: Figure 15 - Insert Risk Factors-Framingham

    Itamar Medical Ltd. Figure 15 – Insert Risk Factors-Framingham Figure 16 - Insert Risk Factor - Reynolds Figure 17 – Insert Risk Factor - European Endo PAT x Device Operation Manual...

  • Page 31: Figure 18 - List Of Previous Studies

    Itamar Medical Ltd. 4.3.3.3 Access previous patient EndoPAT x test records. To access previous Patient EndoPAT x test records, click on Previous Test Records in Patient information and new Study window (Figure 13). Figure 18 - List of Previous Studies...

  • Page 32: Figure 19 - Previous Study Options

    Itamar Medical Ltd. Itamar Medical Ltd. Itamar Medical Ltd. Figure 19 - Previous Study Options Figure 19 - Previous Study Options Figure 19 - Previous Study Options 4.3.3.4 View Signal 4.3.3.4 View Signal 4.3.3.4 View Signal Selecting View Signal will open the previous study and enable the auto analysis of the data.

  • Page 33: Figure 21 - Exported Endopat Tm X File

    Itamar Medical Ltd. 4.3.3.5 Export Selecting the Export option from the Previous Study option (Figure 19) will create a file that can be imported to another EndoPAT x system (Figure 21 below) Figure 21 - Exported EndoPAT x File 4.3.3.6 View Report Selecting View Report will create an automated report in HTML format.

  • Page 34: Conducting Endopat Tm X Study - Operator

    Itamar Medical Ltd. Conducting EndoPAT x Study – Operator The Test section of the screen (Figure 13) is used to finalize new study information and initiate an EndoPAT x Study. Please note that to initiate a new test, the EndoPAT device must be turned on and connected.

  • Page 35: Figure 26 - New Study Screen

    Itamar Medical Ltd. 4.4.2 EndoPAT x Study - Main Screen Figure 26 - New Study Screen The main screen of EndoPAT x study includes the following main sections: • System stability o Indication of leakage detection • PAT Signal Waveform Viewer...
  • Page 36 Itamar Medical Ltd. o Stop the study in middle of test if needed. o Navigation between study stages o Inflate and Deflate buttons for patient setup 4.4.3 Standby Stage Once probes are properly connected (see section Preparation of fingers and hands...

  • Page 37: Figure 27 - Baseline

    Itamar Medical Ltd. When Baseline Stage timer reaches the recommended time, the Occlusion Stage icon becomes enabled ( ) allowing the transition to Occlusion Stage. Baseline recommended time is 6 minutes. Just before end of Baseline stage and before inflation of the blood pressure cuff, press the Max Gain button on the designated occluded signal.
  • Page 38 Itamar Medical Ltd. Occlusion Stage timer ( ) is displayed, displaying time elapsed since the stage started and the recommended time for this stage. If stage elapsed time exceeds the recommended time, a “+” sign is displayed before the timer.

  • Page 39: Figure 28 - End Of Study Comment

    Itamar Medical Ltd. Figure 28 - End of Study Comment 4.4.7 Post-test study screen and automated analysis. Insert comments if needed and Press Save and Continue. The Patient file will be displayed on the screen. Figure 29 - Study Screen...
  • Page 40 Itamar Medical Ltd. 4.4.8 Stopping the Study At any point during the study, you may click on the Stop Test button ( This will automatically release the air pressure and deflate the probes. Stopping a test at any point after “Standby” will stamp the probes as “used” and new probes should be attached if restarting the study.

  • Page 41: Figure 30 - Error Indicator

    Itamar Medical Ltd. 4.4.9 Warning and Error Indications When an unwanted system condition is detected, the user is provided with error / warning indication at the bottom of the screen. Figure 30 - Error Indicator Clicking on either error tooltip or error indication open the following error report:...
  • Page 42 Itamar Medical Ltd. Symbol Severity Sever error condition that impacts study execution Minor/moderate error condition that might impact study execution if not handled in timely manner The time in which the error condition was detected is indicated. Endo PAT x Device...

  • Page 43: Reviewing The Endopat Tm X Study - Doctor (Reviewer)

    Itamar Medical Ltd. Reviewing the EndoPAT x Study – Doctor (Reviewer) This section is applicable only to a user with the Doctor role. 4.5.1 Locating EndoPAT x Study for review Figure 32 - Search Patient Enter the patient’s name or identifier (ID). The system automatically displays the drop-down list of patients that match the entered name / ID.

  • Page 44: Figure 34 - Patient Record - Doctor View

    Itamar Medical Ltd. Figure 34 - Patient Record – Doctor View Clicking on a specific study will open the following pop-up screen Figure 35 – Patient Record – Doctor View: Single Study Review Options Single study review includes the following options: •...

  • Page 45: Figure 36 - Patient Record - Patient View

    Itamar Medical Ltd. 4.5.2.2 Patient Record – Patient View The Patient Record, Patient View (Figure 36) displays the graphs of results and medical indices of a single patient. For discussion on the RHI (Reactive Hyperemia Index) score, please refer to section 7.2. Note that the Other Medical Indices do not affect the RHI score calculation and are entered manually by the operator.

  • Page 46: Figure 37 - Endopat Tm X Study Review Main Screen

    Itamar Medical Ltd. • PAT Signal Waveform Viewer o Display the acquired PAT signals from Probe A and B o Separate gain control for each signal o Study stage bookmarks o Time scale zoom o Timeline marker • Editing Toolbar...
  • Page 47 NOTE To enable the Manual Analysis functions, it is necessary to enable the Manual Research Mode by Itamar Medical technician 4.5.5.1 Marking Segments and Artifacts Tool bar icons provide quick and easy access to the tools used to mark segments and artifacts in research studies, as well as to facilitate automatic ratio calculations between PAT™...

  • Page 48: Figure 38 - Manual Research Mode Analysis And Signal View Screen

    Itamar Medical Ltd. Figure 38 – Manual Research Mode Analysis and Signal View Screen 4.5.5.2 Analysing PAT™ Ratios NOTE After the B and T segments are marked, their PAT™ ratios can be Calculated segment ratios displayed in the left side calculated by clicking T/B icon and of the screen do not have clinical implication.

  • Page 49: Figure 39 - Print Report Through Browser Menu

    Itamar Medical Ltd. 4.5.6 Printing EndoPAT x Study Report Select the Print option on the browser to print the study report. Figure 39 - Print Report Through Browser Menu Endo PAT x Device Operation Manual...

  • Page 50: Preparing For A Study

    Itamar Medical Ltd. 5 Preparing for a Study Preparing the System for a Study Accessories that are required beside the EndoPAT x system: A set of two PAT probes and anchors • Blood pressure cuff (capable of sustaining high pressures for 5 minutes) •...

  • Page 51: Creating/Updating Patient's Record

    Itamar Medical Ltd. Figure 42 - Press to release Figure 43 - Probe disconnected Creating/Updating Patient’s Record 1 Search for existing Patient (4.3.1) or create a new patient record (4.3.2). 2 Update or enter current patient details as follows: All mandatory fields are marked with asterisk and must be filled to proceed to the next step.
  • Page 52 Itamar Medical Ltd. NOTE All text fields should be entered using text letters and numbers. 3 Enter/update Patient’s Risk Factors - Select the risk factor method (Framingham Risk Score, European Risk Scoreor Reynolds Risk Score) and fill in the additional inputs required to calculate Cardio-vascular Risk Factor.

  • Page 53: Table 1 - Risk Factors Mandatory Fields

    Itamar Medical Ltd. Required in Parameter Remark Framingham Reynolds European Gender* Taken from the patient information    main dialog box Systolic blood    pressure* Table 1 – Risk Factors mandatory fields * Parameters that are used in the calculation of the Risk but are part of the main Patient Information Dialog and not the Risk Factors Dialog.

  • Page 54: Conducting An Endopat Tm X Study

    Itamar Medical Ltd. 6 Conducting an EndoPAT x Study Pre-Study WARNING Use the blood pressure cuff-set provided by Itamar Medical for arm occlusion. Usage of non-certified cuff- might compromise the results. 6.1.1 General description The EndoPAT system is comprised of a system console and two independent sensing probes coupled to connecting pneumo-electric tubing and foam finger mounting rings.
  • Page 55 Itamar Medical Ltd. The patient should then be comfortably seated or allowed to lie down in the study room and relax for at least 15 minutes or a sufficient period to reach a relaxed cardiovascular steady- state and to adjust to the room temperature.

  • Page 56: Patient And System Setup

    Itamar Medical Ltd. Patient and System Setup 6.2.1 Study conditions The study should be conducted in a quiet and relaxed atmosphere. Phones, beepers, and other devices which can cause startling noises should be turned off; otherwise, the startle effect on the patient might affect the test result.

  • Page 57: Figure 44 - Applying The Pat™ Probes

    Itamar Medical Ltd. Figure 44 - Applying the PAT™ probes Make sure the tubing forms a loop from the probe, back to the anchor as shown in Figure 44. The patient should be instructed to refrain from moving the fingers to the extent possible.

  • Page 58: Performing The Study

    Itamar Medical Ltd. Performing the Study NOTE Do not change the time or date of the computer during the study. Changing the windows time while recording might result in corrupted study. 6.3.1 Recording baseline Click the STANDBY icon, from the main screen. The system will display the signals from the two PAT™...
  • Page 59 Itamar Medical Ltd. NOTE While in the Standby mode, data is not recorded. Click the BASELINE icon to begin study recording. 6.3.2 Performing arterial occlusion After a stable period of the required baseline signal recording (5-6min.), prepare for the occlusion: 1.

  • Page 60: Figure 46 - Occlusion Quality Assessment

    Itamar Medical Ltd. Left – complete occlusion Right – incomplete occlusion In both panels the bottom signal is the occluded arm. Figure 46 - Occlusion quality assessment 6.3.3 Post Occlusion period When exactly five minutes have passed, deflate the pressure cuff as quickly as possible.

  • Page 61: Review And Analysis

    Itamar Medical Ltd. 7 Review and Analysis During a PAT™ study, recorded signals are viewed in the display window, based on the appearance of the traces, a qualitative evaluation can be performed. However, subsequent review of the study using the special features described in this chapter facilitates a quantitative analysis of the acquired data.

  • Page 62: Study Report

    Itamar Medical Ltd. The HR (Heart Rate) is calculated from the PAT™ signals in the baseline region of interest. 7.2.1 Manual Correction of the Occlusion Borders Click the magic wand to create the automatic analysis borders. Select the occlusion borders as follow: Once automatic analysis is performed (see 4.5.4.1), Occlusion bookmarks are displayed on...

  • Page 63: Figure 47 - Non Selective Population Histograms Of Rhi

    Itamar Medical Ltd. This transformation is a monotonic transformation; therefore, it does not change the dichotomous diagnosis (normal/abnormal) for any individual test. LnRHI provides a better double-sided distribution that is very close to normal distribution (Gaussian) in its nature. The histograms of RHI and LnRHI (based on the analysis of large...

  • Page 64: Additional / Research Features

    Itamar Medical Ltd. The graph presents the distribution function of the LnRHI in the non-selected population. The data used is composed of nearly 10,000 data points collected from different study cohorts worldwide. The mean / median LnRHI in the population (0.7, marked in blue) and the dichotomy threshold for normal endothelial function (0.51, marked in red) are presented as vertical lines...

  • Page 65: Figure 50 - Ai Calculation

    Itamar Medical Ltd. AI in the EndoPAT™ is calculated from the PAT™ pulses at the base-line period of the occluded arm, by averaging multiple valid pulses and finding the systolic peak (P ) and the backward reflected peak (P ) and then using the formula: (P2-P1)/P1. See Figure 50.

  • Page 66: Figure 52- Time Domain Hrv

    Itamar Medical Ltd. particularly the balance between sympathetic and parasympathetic activities. Low HRV has been described as related to various pathological conditions. The EndoPAT™ HRV is calculated from the baseline period, based on the European Society of Cardiology and the North American Society of Pacing Electrophysiology task force standard.

  • Page 67: Study Printing

    Itamar Medical Ltd. Researchers that want to use this index for research purposes can ask Itamar Medical to enable this index as part of the registration process. Study printing You can print the displayed data at any time during off-line review and analysis by selecting the Print option through Windows pull down menu.

  • Page 68: Maintenance

    Only qualified medical personnel should use this equipment. In the event of equipment malfunction all repairs should be executed by qualified Itamar Medical personnel or authorized service agents. Maintenance instructions should be followed closely to avoid unnecessary equipment failure or potential health hazards to the user or patient.

  • Page 69: Troubleshooting

    Itamar Medical Ltd. Itamar Medical Ltd. Itamar Medical Ltd. 9 Troubleshooting 9 Troubleshooting 9 Troubleshooting Description Possible Cause Action Description Description Possible Cause Possible Cause Action Action • Switch on the EndoPAT x device. • • Switch on the EndoPAT Switch on the EndoPAT x device.

  • Page 70: Table 2 - Troubleshooting

    Itamar Medical Ltd. Itamar Medical Ltd. Itamar Medical Ltd. Description Possible Cause Action Description Description Possible Cause Possible Cause Action Action ™ • Replace PAT probe. ™ ™ • • Replace PAT Replace PAT probe. probe. Faulty probe. Faulty probe.

  • Page 71: System Error Messages

    Itamar Medical Ltd. System Error Messages The following table provides a list of system error messages that the user may encounter when running the analysis. Some of the errors may be corrected after proper manual occlusion marking (if the errors are caused by a wrong automatic detection of the occlusion borders).
  • Page 72 AllocationMemory or Program Failure i.e. System software problems that prevents the program NoCorrPulse to complete the analysis (call Itamar Medical customer support). BT_MajorBreakThrough Meaning incomplete occlusion. The amount of blood flow detected during the occlusion period is too high, i.e. there are measured pulses during the occlusion in the occluded hand.

  • Page 73: Table 3 - Error Messages

    AllocationMemory or Program Failure i.e. System software problems that prevents the program NoCorrPulse to complete the analysis (call Itamar Medical customer support). BT_MajorBreakThrough Meaning incomplete occlusion. The amount of blood flow detected during the occlusion period is too high, i.e. there are measured pulses during the occlusion in the occluded hand.

  • Page 74: Technical Information

    Itamar Medical Ltd. 10 Technical Information 10.1 System Minimum Requirements ® An IBM or compatible PC with dual core processor 1.4 GHZ CPU or higher Internet browsers Chrome version 70, Edge version 44, Firefox version 63 or above versions 8.00 GB RAM, Windows 10 64 bits...
  • Page 75 Itamar Medical Ltd. Directive) and related standards. The product is marked with the CE logo. Use-by date Single use, do not re-use Temperature limit Medical device Manufacturer Catalogue Number Serial Number According to the WEEE Directive 2012/19/EU, all waste electrical and electronic equipment (EEE) should be collected separately and not disposed of with regular household waste.
  • Page 76 Itamar Medical Ltd. The product is certified by TUV Rheinland UDI code: The Unique Device Identification System is intended to assign a unique identifier to medical devices Endo PAT x Device Operation Manual...

  • Page 77: Labeling

    Itamar Medical Ltd. 10.4 Labeling 10.4.1 System Label The System Label is located at the bottom of the EndoPAT x device: 10.4.2 Power Rating Label The Power Rating Label is located near the power inlet connector of the EndoPAT device: 10.4.3 Applied Part Label...
  • Page 78 Itamar Medical Ltd. 10.4.4 Packaging labels The following labels are attached to the master package of the EndoPAT x system: Endo PAT x Device Operation Manual...

  • Page 79: Specifications Of Endopat Tm X System

    Itamar Medical Ltd. 10.5 Specifications of EndoPAT x system Properties Description PAT™ Probe Itamar Medical’s proprietary probe only Recording Time Limited by hard disk space, ~35MB per study of 20 minutes Indications 3 LED’s - power, communication, error PAT™ Channel 1÷...

  • Page 80: Appendix A: License Agreement And Limited Warranty

    The document can be viewed at https://www.itamar-medical.com/wp-content/uploads/2020/09/License-Agreement- 09.2020.pdf Should you have any questions concerning this License Agreement, or if you desire to contact Itamar Medical for any reason, please write to: USA: Itamar Medical Inc. 3290 Cumberland Club Drive, Suite 100...

  • Page 81: Appendix B: Regulatory Authorized Representative

    Itamar Medical Ltd. Appendix B: Regulatory Authorized Representative Arazy Group GmbH The Squaire 12, Am Flughafen, 60549 Frankfurt am Main, Germany Endo PAT x Device Operation Manual...

  • Page 82: Appendix C: Manufacturing Declarations According To Iec 60601-1-2

    The use of accessories other than those specified or sold by Itamar Medical as replacement • The use of accessories other than those specified or sold by Itamar Medical as replacement The use of accessories other than those specified or sold by Itamar Medical as replacement •...
  • Page 83 Itamar Medical Ltd. Table 2 - from IEC 60601-1-2:2014 Guidance and manufacturer's declaration – electromagnetic immunity – EndoPAT x (EPX) The EDx is intended for use in the electromagnetic environment specified below; The customer or the user of the EPX should assure that it is used in such an environment.
  • Page 84 Itamar Medical Ltd. Itamar Medical Ltd. Itamar Medical Ltd. Table 3 - from IEC 60601-1-2:2014 Table 3 - from IEC 60601-1-2:2014 Table 3 - from IEC 60601-1-2:2014 Guidance and manufacturer's declaration – electromagnetic immunity – EndoPAT x (EPX) Guidance and manufacturer's declaration – electromagnetic immunity – EndoPAT Guidance and manufacturer's declaration –...
  • Page 85 Itamar Medical Ltd. Table 4 - from IEC 60601-1-2:2014 Recommended separation distances between portable and mobile RF communications equipment and the EndoPAT TM x The EPX is intended for use in the electromagnetic environment specified below; The customer or the user of the EPX should assure that it is used in such an environment.
  • Page 86 Itamar Medical Ltd. Itamar Medical Ltd. Itamar Medical Ltd. Test Test Test Band a) Band a) Band a) Service a) Service a) Service a) Modulation Modulation Modulation Maximum Maximum Maximum Distance Distance Distance Immunity Immunity Immunity Compliance Compliance Compliance frequency...
  • Page 87 Itamar Medical Ltd. Itamar Medical Ltd. Itamar Medical Ltd. Table 5 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Table 5 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Table 5 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment...
  • Page 88 Itamar Medical Ltd. Itamar Medical Ltd. Itamar Medical Ltd. Recommended Separation Distances Recommended Separation Distances Recommended Separation Distances The EndoPAT The EndoPAT x is intended for use in an electromagnetic environment in which radiated x is intended for use in an electromagnetic environment in which radiated...

  • Page 89: Appendix D: Spare Parts List

    Itamar Medical Ltd. APPENDIX D: SPARE PARTS LIST The following items can be ordered and purchased individually: Pneumatic PAT Probe (a box of 12 probes) Pneumo-electric tubing Set of 30 foam finger anchors Accessories Kit Power Cable USB cable EndoPAT...

This manual is also suitable for:

Om1695230

Table of Contents