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Itamar Medical Ltd.

Endo

PAT

x Device

Operation Manual

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

The Applied Part Label is located near the Pneumatic Cable Connectors of the
EndoPAT

x device:

Содержание EndoPAT 2000

Страница 1: ...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...

Страница 2: ...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 oth...

Страница 3: ...w 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...

Страница 4: ...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 Uni...

Страница 5: ...l 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 6...

Страница 6: ...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 histogr...

Страница 7: ...ss 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 t...

Страница 8: ...ethodology 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...

Страница 9: ...rmance 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 w...

Страница 10: ...rly 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 inci...

Страница 11: ...vices 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...

Страница 12: ...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 ac...

Страница 13: ...fy 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...

Страница 14: ...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 ma...

Страница 15: ...ystem 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 inte...

Страница 16: ...the finger Its extended pressure field also excludes spurious venous signals while continuously recording the digital arterial pulse wave Studies using the EndoPATTM x device are easily performed in a...

Страница 17: ...oam 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 requiremen...

Страница 18: ...ated 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 EndoPATTM x device Power supply AC Inlet c...

Страница 19: ...nt 2 Connect the USB cable to the communication port on the EndoPATTM x 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 cab...

Страница 20: ...software 2 Insert the EndoPATTM x software CD into the CD drive The installation program will load automatically Alternatively you may execute the Itamar Installer application from the installation C...

Страница 21: ...irm to stop the installation and exit the installer on the popup window by clicking OK 14 An icon will be added to the desktop after installation link to the EndoPATx application WARNING The EndoPATTM...

Страница 22: ...x Device 16 Operation Manual 3 6 Shutting Down the System a Shut down the EndoPATTM x software program by clicking on the X on the upper right corner b Switch OFF the EndoPATTM x device using the on...

Страница 23: ...als access to a comparison view of all test results of single patient generate the report for patient view 3 Local Administrator is assigned with privileges to set user name role and password as well...

Страница 24: ...x Device 18 Operation Manual Figure 5 Local admin Pull down menu Select Users a list of existing users will appear and an option to Create Users Select Create User the following screen will appear Fig...

Страница 25: ...ord 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 4 4 Operator Patient Management Screens 4 4 1 Search for an e...

Страница 26: ...h the entered details 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 4 2 Add New Pati...

Страница 27: ...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 Use this screen to...

Страница 28: ...13 Patient Record and New Study 4 4 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...

Страница 29: ...and updated 4 4 3 2 Update Edit patient Risk Factors To review and update the risk factors click on the Risk Factors link through Patient Information and New Study window Figure 13 Select Method Reyno...

Страница 30: ...To access previous Patient EndoPATx test records click on Previous Test Records in Patient information and new Study window Figure 13 Figure 17 List of Previous Studies Selecting a study from this lis...

Страница 31: ...le the auto analysis of the data Figure 19 View Signal Screen Pressing the Magic Wand Icon will generate the RHI LnRHI and HR Click Patient Record button to return to the Patient Records screen 4 4 3...

Страница 32: ...Figure 13 is used to finalize new study information and initiate an EndoPATx Study Please note that in order to initiate a new test the EndoPATTM x device must be turned on and connected Patient setu...

Страница 33: ...ompleted click Start New Test button to start the EndoPAT study The following window will open Figure 23 Open Probs Follow the instructions in section 5 Preparing for a Study and section 6 Conducting...

Страница 34: ...iew of occlusion quality in the occluded signal It should be selected on the designated occluded hand just before occlusion o Study stage bookmarks and Study Control buttons enable navigation between...

Страница 35: ...ignal is not being recorded in Standby mode once the system is stable and signal quality is acceptable start the recording by pressing the Baseline button Note Standby mode is for assessing signal qua...

Страница 36: ...gnal Figure 25 Baseline 4 5 5 Occlusion Stage Follow instruction in 6 3 2 for performing a correct occlusion Once the blood pressure cuff is inflated click on the Occlusion Stage icon to start the Occ...

Страница 37: ...lusion icon 4 5 6 Post occlusion Stage Click on the Post Occlusion Stage icon to start the Post Occlusion Stage timer and time line The icon is changed to reflect that the stage is active Baseline and...

Страница 38: ...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 27 Study Screen Press the Magic Wand Icon...

Страница 39: ...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 In addition Visit number wil...

Страница 40: ...ror Indications When an un wanted system condition is detected the user is provided with error warning indication at the bottom of the screen Figure 28 Error Indicator Clicking on either error tooltip...

Страница 41: ...eration Manual 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...

Страница 42: ...ay select the patient from the drop down list or click on Search button to open a search window listing the patients that match the entered details Figure 31 Search Button List of Patients Selecting a...

Страница 43: ...ctor Single Study Review Options Single study review includes the following options View Signal Review signal and edit occlusion borders if needed Export view section 4 4 3 5 Export CSV view section 4...

Страница 44: ...tion Manual Figure 34 Patient Record Patient View 4 6 3 Study PAT Signal Review Screen The main screen of EndoPATx study review includes the following main sections PAT Signal Waveform Viewer o Displa...

Страница 45: ...screen of EndoPATx study Figure 35 EndoPATx Study Review Main Screen 4 6 4 EndoPATx Study Editing 4 6 4 1 Automatic Analysis Automatic analysis is performed by clicking on the Wand button in the Editi...

Страница 46: ...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 6 5 1 Marking Segmen...

Страница 47: ...os After the B and T segments are marked their PAT ratios can be calculated by clicking T B icon and then displayed in the left side of the screen Note that these results might be slightly different f...

Страница 48: ...amar Medical Ltd EndoPATTM x Device 42 Operation Manual 4 6 6 Printing EndoPATx Study Report Select the Print option on the browser to print the study report Figure 36 Print Report Through Browser Men...

Страница 49: ...ipment may impact patient and operator safety and system performance Switch on the computer and the EndoPATTM x device Launch the EndoPATTM x software and login to the system 5 2 Connecting the PAT Pr...

Страница 50: ...already in the system Patient First and Last name Enter the patient s complete name initials or other identifier Date of Birth Enter the patient s month day and year of birth This can be done manuall...

Страница 51: ...tal cholesterol Either mg dL or mmol L HDL cholesterol hsCRP High sensitivity CRP Diabetic Reynolds and Framingham doen t support diabetic patients the risk will be calculated only if positively indic...

Страница 52: ...sk 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 4 Enter Test parameters Enter th...

Страница 53: ...t the discretion of the patient s physician and is generally based upon the following criteria Symptoms and complaints Medical history Risk factors Current medications Restrictions on use Section 1 5...

Страница 54: ...r or lie down comfortably In either case the patients hands must be supported at approximately heart level 6 1 6 Preparation of fingers and hands before a study The finger should be inspected for any...

Страница 55: ...connected If the probes have been used a warning message will be displayed when you try to inflate the probes 6 2 3 Patient preparation First ensure that a blood pressure cuff is placed on the the de...

Страница 56: ...the tube to the tip of the anchored finger over the finger nail Figure 41 The patient should be instructed to refrain from moving the fingers to the extent possible Both patients forearms should be su...

Страница 57: ...ignal for at least 1 minute If the signal seems noisy make sure that the probes are not in touch with anything As the system equilibrates having a few leaks in the first few minutes is normal If you e...

Страница 58: ...ast 60mmHg above systolic blood pressure and no less than 200mmHg Verify total cessation of blood flow to the hand as reflected by a total absence of PAT signal from the occluded hand If the appearanc...

Страница 59: ...clicking the Finish Test button 6 3 4 After the Study is Completed Clicking the Finish Test button ends the recording This will also deflate the probes automatically allowing their removal from the p...

Страница 60: ...on borders and marks with two vertical blue lines its beginning and end and also marks blue the whole signals area between these two lines Proper identification of the occlusion area is critical for t...

Страница 61: ...to improve the fit of the occlusion area Zoom in to fine tune the location of the occlusion markers Once the manually selected occlusion is marked click on the icon to run the automatic analysis using...

Страница 62: ...t 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 nonselect...

Страница 63: ...othelial Function Index in the software is set to RHI and not to LnRHI the same LnRHI graph will appear and the RHI values threshold population median mean and study results will appear in brackets ne...

Страница 64: ...th a strong family history of premature CVD The socially deprived Subject with diabetes risk may be 5 fold higher in women with diabetes and 3 fold higher in men with diabetes compared to those withou...

Страница 65: ...y the EndoPAT device Arterial stiffness is an independent risk factor for later CVD events it reflects the structural nature and basal tonus of the vessel and is not necessarily correlated to endothel...

Страница 66: ...is a measure of heart beat to beat variability in either time or frequency domain HRV reflects the status of the autonomic nervous system ANS and particularly the balance between sympathetic and para...

Страница 67: ...n paper by Hamburg et al Cross Sectional Relations of Digital Vascular Function to Cardiovascular Risk Factors in the Framingham Heart Study presented an index to be used with the EndoPAT device terme...

Страница 68: ...dical Ltd EndoPATTM x Device 62 Operation Manual 7 7 Study printing You can print the displayed data at any time during off line review and analysisby selecting the Print option through Windows pull d...

Страница 69: ...hazards to the user or patient 1 Inspect all cords and ensure they are not frayed or damaged Verify that all plugs connectors and cables are securely connected Gently wrap tubes around the rear panel...

Страница 70: ...fuse holder to the switch plug in the power cable and turn on the EndoPATx device 2 No communication between PC station and EndoPATTM x device the COMM LED on the device is not lit EndoPATTM x power...

Страница 71: ...ze as a separator between the test finger and the adjacent finger securing it in place with some medical tape 5 The probes do not deflate automatically after pressing stop Either you neglected to pres...

Страница 72: ...mar Medical customer support Baseline duration is shorter than minimum required Less than 2 min and 20 sec valid baseline signals Occlusion Time less than minimum required Occlusion is 90 sec or less...

Страница 73: ...or above versions 8 00 GB RAM Windows 10 64 bits 20 GB free hard disk space 720p display or better One available USB 2 0 port for connecting the DAS Optional 2nd USB port for local printer Optional Ha...

Страница 74: ...e 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 d...

Страница 75: ...tem Label is located at the bottom of the EndoPATTM x device 10 4 2 Power Rating Label The Power Rating Label is located near the power inlet connector of the EndoPATTM x device 10 4 3Applied Part Lab...

Страница 76: ...Itamar Medical Ltd EndoPATTM x Device 70 Operation Manual 10 4 4Packaging labels The following labels are attached to the master package of the EndoPATTM x system...

Страница 77: ...elective Gain 1 50 000 Selectable Time Base 10 sec 2 hours per screen Power Supply Input 100 240 VAC 50 60 Hz Isolation Double Patient Isolation 4kVAC Fuse 1A x2 Temperature Operation Room temperature...

Страница 78: ...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...

Страница 79: ...Itamar Medical Ltd EndoPATTM x Device 73 Operation Manual Appendix B Regulatory Authorized Representative Arazy Group GmbH The Squaire 12 Am Flughafen 60549 Frankfurt am Main Germany...

Страница 80: ...ty of the unit Electromagnetic Emissions EndoPATTM x is intended for use in the electromagnetic environment specified in the following tables 1 2 3 4 5 6 and 6a below The user and or installer of the...

Страница 81: ...ment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 2 kV Signal input output to earth 1 kV line s to line s N A N A Mains power quality should be that of a typical commercial or hospit...

Страница 82: ...anufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level...

Страница 83: ...0 2 0 4 1 0 1 0 37 0 64 1 3 2 6 1 1 17 2 4 8 10 3 7 6 4 13 26 100 11 7 20 40 80 Table 5 from IEC 60601 1 2 2014 Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment...

Страница 84: ...lationb 217 Hz 2 0 3 28 28 5240 5 100 5 800 WLAN 802 11 a n Pulse modulationb 217 Hz 0 2 0 3 9 9 5500 5785 NOTE If necessary to achieve the IMMUNITY TEST LEVEL the distance between the transmitting an...

Страница 85: ...1 700 1 990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulatio nb 217 Hz 2 0 3 28 28 1845 1970 2450 2 400 2 570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulatio n...

Страница 86: ...00MHz d 1 17 P 800MHz to 2 5GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 73 1 1 17 1 17 2 3 10 3 7 3 7 7 3 100 11 7 11 7 23 For transmitters rated at a maximum output power not listed above the rec...

Страница 87: ...PENDIX D SPARE PARTS LIST The following items can be ordered and purchased individually Pneumatic PATTM Probe a box of 12 probes Pneumo electric tubing Set of 30 foam finger anchors Accessories Kit Po...

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