Itamar Medical Endo PAT x System Operation Manual
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Itamar Medical Endo PAT x System Operation Manual

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Itamar Medical Ltd.
Endo PAT ™ x System
Operation Manual for US
Itamar Medical REF OM1695240
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™ , EndoScore™ and PAT™ are trademarks of Itamar Medical, Ltd.
Endo PAT™x
1
Operation Manual

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Summary of Contents for Itamar Medical Endo PAT x System

  • Page 1 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™ , EndoScore™ and PAT™ are trademarks of Itamar Medical, Ltd. Endo PAT™x Operation Manual...
  • Page 2 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...
  • Page 3 Itamar Medical Ltd. Record of Editions Revision Date Description Chapter Pages 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)

  • Page 4: Table Of Contents

    Itamar Medical Ltd. Table of Contents General Information ....................1 1.1 Intended Use of the EndoPAT™x 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...
  • Page 5 Itamar Medical Ltd. 5.3 Creating/Updating Patient’s Record ..............44 Conducting an EndoPAT™x Study ..............47 6.1 Pre-Study ........................47 6.2 Patient and System Setup ..................49 6.3 Performing the Study .....................50 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...
  • Page 6 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...
  • Page 7 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 –...

  • Page 8: 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 9 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 10: Equipment Classification

    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.

  • Page 11: Quality Assurance System: En Iso 13485

    The device is not intended as a screening test in the general patient population. • The device is not defibrillation proof. • 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.
  • Page 12 Itamar Medical Ltd. STANDARD Medical electrical equipment – Part 1-2: EN 60601-1-2:2015 General requirements for basic safety [the product was developed and essential performance - Collateral according to: IEC 60601-1-2: 2014 standard: Electromagnetic compatibility (Ed.4)] - Requirements and tests Medical Device Software – Software Life...
  • Page 13 Itamar Medical Ltd. STANDARD Medical electrical equipment - Part 1-6: EN 60601-1-6:2010 General requirements for basic safety [the product was developed and essential performance - Collateral according to: IEC 60601-1-6:2010 + standard: Usability AMD1:2013] Medical devices - Application of usability...

  • Page 14: Conventions Used In This Manual

    Itamar Medical Ltd. Conventions Used in this Manual 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. 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.
  • 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. Unauthorized personnel should not be allowed access to the system.

  • 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. 3 Installing the System Basic System Configuration 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 finger anchors Figure 1 –...

  • Page 19: System Description

    Itamar Medical Ltd. 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 •...

  • Page 20: Connecting The Endopat™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. Place the EndoPAT™x device and computer on a stable platform in close proximity to the examination bed or chair.

  • Page 21: Endopat™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. Close all open applications operating on the computer, including background applications, before installing the EndoPAT™x software.
  • Page 22 Itamar Medical Ltd. When screen appears press “No” (don’t confirm restart!) When the below screen appears click on “Summary” Then you should see “Itamar EPx was successfully installed” Click on the small arrow on the right corner and choose “Quit”...

  • Page 23: Uninstalling Endopat™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 Shut down the EndoPAT™x software program by clicking on the “X” on the upper right corner. Switch OFF the EndoPAT™x device using the on/off switch on the back panel.

  • Page 24: Endopat™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™x: EndoPAT™x Operator: assigned with privileges for conducting EndoPAT™x...

  • 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).

  • 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 Selecting a study from this list opens a pop-up screen that allows the review of the study signal, export the signal, view, and issue an automated report and export to CSV format.

  • Page 32: Figure 19 - Previous Study Options

    Itamar Medical Ltd. Figure 19 - Previous Study Options 4.3.3.4 View Signal Selecting View Signal will open the previous study and enable the auto analysis of the data. Figure 20 - View Signal Screen Pressing the Magic Wand Icon will generate the RHI, LnRHI and HR.

  • Page 33: Figure 21 - Exported Endopat™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™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™x 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 Signal Waveform Viewer • o Display the acquired PAT...
  • Page 36 Itamar Medical Ltd. o Zoom out buttons Study Control • 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. Just before end of Baseline stage and before inflation of the blood pressure cuff, press the Max Gain button on the designated occluded signal. Figure 27 - Baseline 4.4.5 Occlusion Stage Follow instruction in 6.3.2 for performing a correct occlusion. Once the blood pressure...
  • Page 38 Itamar Medical Ltd. icon becomes enabled ( ) allowing the transition to Post-Occlusion Stage. Occlusion time is 5 minutes and should not be extended even if additional pressure is required to improve occlusion quality following review of occlusion quality. When the timer displays exactly 5 min, quickly release the air from the blood pressure cuff on the occluded arm and click on Post Occlusion icon 4.4.6 Post occlusion Stage...

  • 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. 4.4.10 Operational Warning and Error Indications When an unwanted system condition is detected when running the study , the user is provided with error / warning indication at the bottom of the screen. Figure 30 - Error Indicator...
  • 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™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. Figure 36 - Patient Record – Patient View 4.5.3 Study PAT Signal Review Screen The main screen of EndoPAT™x study review includes the following main sections: • Signal Waveform Viewer o Display the acquired PAT signals from Probe A and B...

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

    Itamar Medical Ltd. • Study Results o Calculated scores and parameters Figure 37 below describes the main screen of EndoPAT™x study. EndoPAT™x Figure 37 - Study Review Main Screen 4.5.4 EndoPAT™x Study Editing 4.5.4.1 Automatic Analysis Automatic analysis is performed by clicking on the Wand button in the Editing Toolbar.
  • Page 47 (not necessarily endothelial dysfunction applications). 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 After the B and T segments are NOTE Calculated segment ratios displayed in marked, their PAT™ ratios can the left side of the screen do not have clinical be calculated by clicking T/B 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. Preparing for a Study Preparing the System for a Study Accessories that are required beside the EndoPAT™x system: A set of two single-use 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 manually current patient details as follows: All mandatory fields are marked with asterisk and must be filled to proceed to the next step.

  • Page 52: Table 1 - Risk Factors Mandatory Fields

    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 Score or Reynolds Risk Score) and fill in the additional inputs required to calculate Cardio-vascular Risk Factor.
  • Page 53 Itamar Medical Ltd. 4 Enter Test parameters Enter the patient’s blood pressure (or select “Use Fixed Values”). Enter Visit number (Mandatory) 5 Click “Start New Test” to start the EndoPAT™x study flow. Follow the instructions detailed in 6 Conducting an EndoPAT™x Study.

  • Page 54: Conducting An Endopat™X Study

    Itamar Medical Ltd. 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. which might hamper venous blood return, causing venous pooling in the arm (which is deleterious to the test performed). 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 Set 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. The patient should be kept comfortable and fully relaxed and asked to refrain from talking.

  • Page 57: Performing The Study

    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 Itamar Medical Ltd. 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. 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. Select Max Gain button of the occluded arm (either probe A or probe B).

  • 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. 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 the PAT Waveform Viewer. You can adjust the stage timing by dragging the bookmark.

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

    Itamar Medical Ltd. 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 dataset of nonselective populations) are shown in Figure 47...

  • Page 64: Study Printing

    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...

  • Page 65: Maintenance

    This chapter describes preventive and regular maintenance for the EndoPAT™x system. 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 66: Troubleshooting And System Error Messages

    Itamar Medical Ltd. 9 Troubleshooting and System Error Messages Troubleshooting Description Possible Cause Action The EndoPAT™x The EndoPAT™x • Switch on the EndoPAT™x device. device does not device power is switch on (the switched off. POWER LED on the Power cable is not •...

  • Page 67: Table 2 - Troubleshooting

    Itamar Medical Ltd. Description Possible Cause Action Frequent pressure The pneumatic Verify that the pneumatic probe cable is securely • leaks during study probe cable is not connected to the probe and to the EndoPAT™x well connected to device and that the connections are free from lint or the probe or to the other residues.

  • Page 68: System Error Messages

    (1.5 - 2.5 min post occlusion). AllocationMemory or Program Failure i.e. System software problems that prevents the NoCorrPulse program 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 69: 10 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 70 Itamar Medical Ltd. SYMBOL EXPLANATION Type BF applied part The product complies with the CE mark according to MDD (Medical Device Directive) and related standards. The product is marked with the CE logo. Use-by date Single use, do not re-use...
  • Page 71 Itamar Medical Ltd. SYMBOL EXPLANATION Authorized representative in the European Community Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner Medical Device The product is certified by TUV Rheinland UDI code:...

  • Page 72: 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™x device: 10.4.3 Applied Part Label The Applied Part Label is located near the Pneumatic Cable Connectors of the EndoPAT™x device:...
  • Page 73 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 74: Specifications Of Endopat™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 Selective Gain PAT™ Channel 1÷...

  • Page 75: 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 76: 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 77: Appendix C: Manufacturing Declarations According To Iec 60601-1-2

    - before clinical use – to check the equipment for correct operation under the conditions of use. The use of accessories other than those specified or sold by Itamar Medical as • replacement parts may have the consequence of increasing the emissions or decreasing the immunity of the unit.
  • Page 78 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 79 Itamar Medical Ltd. Table 3 - from IEC 60601-1-2:2014 Guidance and manufacturer’s declaration – electromagnetic immunity – EndoPAT™x (EPX) 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 80 Itamar Medical Ltd. Table 4 - from IEC 60601-1-2:2014 Recommended separation distances between portable and mobile RF communications equipment and the ™x EndoPAT 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 81 Itamar Medical Ltd. Test Band a) Service a) Modulation Maximum Distance Immunity Compliance frequency (MHz) power Test level level (MHz) (V/m) (V/m) 1720 1 700 – GSM 1800; Pulse 1 990 CDMA 1900; modulationb) GSM 1900; 217 Hz 1845 DECT;...
  • Page 82 Itamar Medical Ltd. Table 5 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test Band Service Modulation Maximum Distance IMMUNITY Compliance frequency (MHz) power TEST LEVEL level (MHz) (V/m) (V/m) Pulse 380 –390 TETRA 400 modulation...
  • Page 83 Itamar Medical Ltd. Recommended Separation Distances The EndoPAT™x is intended for use in an electromagnetic environment in which radiated radiofrequency disturbances are controlled. The user and/or installer of the unit can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile radiofrequency communications equipment (emitters) and the EndoPAT™x, according to the maximum...

  • Page 84: 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™x software CD Operation manual Endo PAT™x Device...

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