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Endo PAT 2000 Operation Manual

1. 4 1 7 Conventions Used in this Manual eese e eee nennen 5 1 8 Safety Precautions aise 0 2 2 00 92 2 2010 30000900022 a va uud Uns ee 6 2 SVsteli OVeEVIeW cec eei ea cues ecDuuu uu ue e e Ea E 8 2 1 How to Use this Manuali nu ci iei daos ma ca anu cc pR aeo va xR Ea ua acta cra BA Ex a EB RR Ed 8 3 Installing the System ceo eer eere rennen nnne 9 3 1 Basic System Configuration Leere erre rere eere enam n nnn 9 3 2 System descrip iois cuoshlsiuechuuiddicueeueEieueDeau due tauec eue cUE Eu eUE 10 3 3 Connecting the Endo PAT 2000 device to the Computer 11 3 4 Endo PAT 2000 Software Installation eere 12 3 5 Installing the RS 232 to USB adaptor 15 3 6 RO PA NO Ma 15 3 7 Uninstalling Endo PAT 2000 Software eene 19 3 8 Shutting Down the System 1 Leere e cree Leere ee rre nura n 19 4 Software Description e esee see rere eene nennen 20 4 1 Nani SCECOILo 22 uh ie endete creer ER SEIT PETI sce IERI YARE KE ERAI EE RREEERAKT ICE URE 20 4 2 Main Screen Menu Commands eee eee eene enne n uana nns 22 4 3 Main Screen Tool AA 22 4 4 COMMPBUTING the SVSLOI cccaccacuss occaeca casco sa sci ees pesa sine a aces Siea R ERRERA 24 4 5
2. 11 Fiure 4 Installshield NVIZAb maus miento to dvsut lal et E 12 Figure o License agree meni i599 xe RM uci E badican alee AI 13 Figure 6 Installation folder SE toria uoi stu eH AE 13 Figure 7 Ready to install the program screen sese 14 Figure C ompletion or installation 22 2 eto OESTE ts daos Nee e te ina Qon odd a 14 Foe SERS aO Pema etus adios ne AA AA TE ee ee eee 16 Proure 10 Reststraton DIOS Aa aa 17 Figure 11 Registration request file instructions essen 18 Foure T2 Mam Sere ionerne AA AAA 20 Figure 15 Fill site name dialog Da 21 Feur 14 ReblIstrdt mc remunc en AA EE ete cae teenie toes 21 Figure 15 Gain and time base scroll boxes ce eeeeeeeseeeeeeeeecceeeeeeeeeeeeaaeeeeeeeeeeeees 24 FEieure T6 s The Setup COMM and aaa 25 Fiure 7 cbhesetup dialog DOK ai seduce print oui abl citet EA qud apa cis Eua En SUO 25 Figure 18 Report Appearance dialog box sssseeeeeeeeeeee nene 27 Figure T9 The example for report hedder sererai e e ecco 27 Figure 20 The PATographer Information dialog box wweeeeeeemenenennna 28 EndoPAT 2000 V Operation Manual Itamar Medical Ltd Ligure SCOM POr Se AAA 30 Figure 22 serune AMO SEE pressen e e e ESE 31 Fisure 25 CMCKING AAA AA AA WAA AAA AA WAA 31 Foure 24 5 Dress UO AA AAA T ERE 31 Figure 2 Probe dISCODHBe ClO Aa 3 Figure 26 Patient information dial
3. L Probe OK Serial Number 30 DEE Batch Number 65 Status Used Figure 46 Probes Information EndoPAT 2000 Device 62 Operation Manual Itamar Medical Ltd If a probe is missing or cannot be read NA will appear instead of probe s information 9 Troubleshooting l Endo PAT 2000 Device The Endo PAT 2000 device does not switch on the orange LED on the device is not on No communication between PC station and Endo PAT 2000 device the green LED on the device is not lit the Study icon in the main screen remains dimmed or the PAT button on the bottom right of the S W screen 1s red instead of green Frequent pressure leaks during study The Endo PAT 2000 device power is switched off Power cable is not plugged to the power outlet Power cable is not connected to the Endo PAT 2000 device Endo PAT 2000 power switch is off Communication cable between PC station and Endo PAT 2000 device is not connected Another application such as Palm Pilot Hot Sync is assigned to the COM port The communication cable is connected to the wrong COM port USB to Serial adapter not installed or installation did not complete properly The pneumatic probe cable is not well connected to the probe or to the Endo PAT 2000 device Faulty probe Faulty pneumatic cable e Replace PAT probe e Replace pneumatic cable Switch on the Endo PAT
4. 2 Configuring the MOXA Adapter 2 1 Plug in the adapter to your USB port Figure 50 MOXA Adapter 2 2 Wait for the following windows to appear Found New Hardware Wizard Welcome to the Found New Hardware Wizard Windows will search for current and updated software by looking on your computer on the hardware installation CD or on the Windows Update Web site with your permission Can Windows connect to Windows Update to search for software CO Yes this time only OO Yes now and every time connect a device CO No not this time Click Next to continue Figure 51 MOXA Adapter Configuration XP2 2 3 Select the No not this time option and click the Next button The following window is displayed EndoPAT 2000 Device 80 Operation Manual Itamar Medical Ltd Found Mew Hardware Wizard This wizard helps you install software for UPort 1110 f If pour hardware came with an installation CD cem ar floppy disk insert it now What do you want the wizard to do O Install from a list ar specific location dansi Click Mest to continue Figure 52 MOXA Adapter Configuration XP3 2 4 Select the Install the software automatically Recommended option then click the Next button The following window appears Found New Hardware Wizard Please wait while the wizard searches si LPart 1110 Figure 53 MOXA Adapter Configuration XP4 2 5 Wait for the insta
5. Abnormal LnRHI lt 0 51 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 dataset of nonselective populations are shown in Figure 38 and Figure 39 respectively blue represents the actual numbers and red represents the calculated equivalent normal distribution of the same mean and standard deviation RHI 9 RHI normal RHI value Figure 38 non selective population histograms of RHI EndoPAT 2000 Device 50 Operation Manual Itamar Medical Ltd LnRHI 9 LnRHI normal 0 6 2001 0 4 0 9 14 1 9 LnRHI value Figure 39 non selective population histograms of LnRHI The LnRHI distribution curve in a non selected population is included in the report Figure 40 and displays the LnRHI result in respect to non selected population LnRHI 0 98 0 4 0 2 0 0 2 0 4 0 6 0 6 1 1 2 1 4 1 6 Figure 40 LnRHI distribution in non selective population The graph presents the distribution function of the LnRHI in the nonselected population The data used is composed of nearly 10 000 data points collected from different study cohorts worldwide The mean median LnRHI in the popul
6. Itamar Medical Ltd 3 3 Connecting the EndoPAT 2000 device to the Computer NOTE The Endo PAT 2000 system requires the use of a serial RS232 port in the computer with a standard 9 pin RS232 cable The Endo PAT 2000 device can alternatively be connected through a USB to RS232 adapter supplied with the system 1 Place the EndoPAT 2000 device and computer 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 2 Connect the USB to RS232 adapter to the communication port on the Endo PAT 2000 device and to one of the computer s USB ports Hand tighten the screws to secure the adaptor see Figure 3 In case RS232 cable is used connect it to both Endo PAT 2000 device and computer and tighten the connecting screws 3 Connect both pneumo electric tubing to the Endo PAT 2000 device s front panel pneumo electric connectors and secure by hand tightening the screws see Figure 3 4 Make sure the power switch 1s off Connect the power supply first to the Endo PAT 2000 device and then to an electrical outlet Turn the power switch on 5 The power indicator light will glow orange indicating that the power is turned on Tighten screws of pneumo electric tubes Tighten screws of USB to COM adaptor Figure 3 Connection of pneumo electric tubing and USB adaptor NOTE When us
7. WARNING This program is protected by copyright law and international treaties Cancel Figure 4 Installshield wizard 4 Read the license agreement and select the I accept option to agree to license terms Continue with the installation by pressing next Figure 5 Click I do not accept if EndoPAT 2000 Device 12 Operation Manual Itamar Medical Ltd you do not accept the license terms and wish to abort the installation fe Endo PAT2000 Setup E License Agreement PAT Please read the following license agreement carefully f v LICENSE AGREEMENT License To User From Itamar IMPORTANT PLEASE READ THIS LICENSE AGREEMENT CAREFULLY BEFORE INSTALLING OR OTHERWISE USING THE LICENSED SOFTWARE 45 DEFINED BELOW OR THE PRODUCT WITH WHICH YOU RECEIVED THIS LICENSE AGREEMENT THIS LICENSE AGREEMENT APPLIES TO a ALL LICENSED SOFTWARE b ALL LICENSED PRODUCTS 45 DEFINED BELOW AND c ALL THIRD PARTY PRODUCTS AS DEFINED BELOW SHOULD YOU HAVE ANY QUESTIONS CONCERNING THIS LICENSE AGREEMENT PLEASE CONTACT THE VENDOR FROM WHICH YOU PURCHASED THE LICENSED SOFTWARE LICENSED PRODUCT OR THIRD PARTY PRODUCT YOU MAY ALSO CONTACT ITAMAR AT THE ADDRESS PROVIDED AT THE END OF THIS C I do not accept the terms in the license agreement Installshield lt Back cea Figure 5 License agreement 5 Click Next to set the default target folder for software installation or click
8. c Post occlusion signal to baseline signal ratios at 14 consecutive 30 sec time BD BQ segments for the control side suffix c RecordingTime Date and time of test recording nalysisTime Date and time of test analysis ecordingVersion The software version used for the recording nalysisVersion The software version used for the analysis Site name amp PATographer identification omment1 Comment2 UserField1 UserField2 FRHI HRV error message HRV general information HRV time domain results HRV frequency domain results Table 4 Table information Note fields G to K and CB CN contain additional Research features restricted to non US and in research versions only They will be calculated based on the license file of the software UJ UJ CoD 2 UJ BV B UJ lt UJ x DJ Z O gt O UJ gt CB CD CE CF CK CL CN EndoPAT 2000 Device 57 Operation Manual Itamar Medical Ltd 7 8 Batch Analysis The Endo PAT 2000 software allows the user to perform a batch automatic analysis on a group of studies as follows e The batch analysis command analyzes all the files located in a selected folder If necessary copy the files you wish to analyze to a new folder before proceeding e Select Batch Analysis From the Test Analysis menu e From the dialog box that opened select the folder that contains the files you wish to analyze and click OK e The automatic analysis
9. 2000 device Switch off the Endo PAT 2000 device Plug the power cable to the power outlet Switch on the Endo PAT 2000 device Switch off the Endo PAT 2000 device Plug the power cable to the Endo PAT 2000 device Switch on the Endo PAT 2000 device Verify that the orange LED is on Switch on the Endo PAT 2000 device Verify that the communication cable is connected properly Close all background applications Verify that the COM port connected to the Endo PAT 2000 device is not in use by another application Plug communication cable into the other COM port Try setting another COM port in the application Follow instructions provided with the USB to Serial adapter to verify proper installation Verify that the pneumatic probe cable is securely connected to the probe and to the EndoPAT 2000 device and that the connections are free from lint or other residues Operation Manual Itamar Medical Ltd Noisy signal The probes do not deflate automatically after pressing stop The signal looks flat and does not react to gain amplification License doesn t fit the computer Software license expired Very long inflate followed by Major Leak message Endo PAT 2000 Device Something is in contact with the probes or the tubes Either you neglected to press Go and thus still in the Stand By mode or there is a software hardware communication error The relevant PAT channel is
10. Change to select a different folder for the installation Figure 6 fe Endo PAT2000 Setup Ex Destination Folder PAT Click Next to install to this folder or click Change to install to a different folder 1 wv A Install Endo PAT 2000 to C Mtamar Medicah change Installshield Figure 6 Installation folder selection EndoPAT 2000 Device 13 Operation Manual Itamar Medical Ltd NOTE It is not recommended to install the program in the My Documents or Desktop folders 6 Press Install to complete the installation process or Back to review or change any of your installation settings Figure 7 i Endo PAT2000 Setup x Ready to Install the Program PAT The wizard is ready to begin installation f kd Click Instal to begin the installation If you want to review or change any of your installation settings click Back Click Cancel to exit the wizard Installshield Cancel Figure 7 Ready to install the program screen 7 Press Finish when the installation is completed Figure 8 i amp Endo PAT2000 Setup X InstallShield Wizard Completed The InstallShield Wizard has successfully installed Endo PAT2000 Click Finish to exit the wizard Figure 8 Completion of installation 8 Two icons will be added to the desktop after installation link to the application and a link to the data folder study files storage 9 If used install the
11. Enter the patient s complete name initials or other identifier or it can be left empty optional field e Age Enter the patient s age This can be done manually or by pressing the arrow key until the correct age appears in the window mandatory field e Gender select either male or female mandatory field e Patient Height and Weight mandatory fields Units are set according to the computer defaults either centimeters and Kg or feet inch and lbs e Diastolic Blood Pressure mandatory field unless the Fixed pressure mode was selected in the set up screen Figure 17 e Systolic Blood Pressure mandatory field unless the Fixed pressure mode was selected in the set up screen Figure 17 e Comments optional field e User Field 1 Temp optional field Up to 10 characters length of free text Designed to enter the room temperature at the beginning of the test e User Field 2 Nails optional field Up to 10 characters length of free text Designed to enter the patient s nail length OK or over 5 mm one fifth of an inch beyond the tip of the finger tissue e PATographer optional field select from the pick list or type directly into the field the name of the PATographer to be associated with the study e Risk Factors this will open a dialog box about additional inputs required to calculate Cardio vascular Risk Factor See paragraph 3 below e New Patient button will clear
12. The options are the LnRHI or the previous index the RHI See section 7 4 for more information about the 2 indices In the Cardiovascular Risk Factors frame enter the default method for calculating risk factor to be used in the system This method will be used as the default option but can be changed per patient Go to section 7 5 to read more about the different Risk Factors methods In the same frame also set the units to be used for cholesterol measurement by your health system The options are mg dL or mmol L This will be used in the Cardiovascular Risk Factor calculation only Registration reminder message 1s presented as long as you didn t register the system and got a license file As registering your system 1s optional disabling this reminder is possible by turning this flag off To read more about the registration process see section 3 6 To enable the Manual Research mode select the Manual Research mode checkbox The entire Test analysis menu is enabled See 7 5 below The Countdown Clock timer 1s set to 5 minutes by default To change this value 1 through 15 select the appropriate value from the drop down menu To configure the report press the Report Setup button This will open the report appearance dialog In this dialog the Clinique details a logo and 3 text lines can be updated These details will be used as a header to all Endo PAT reports Notice that the logo size is limited big 1mages
13. connect COM TO COM ia 89 List of Tables Table 1 Main screen pull down menu commands sssessseooeeessssssssserrssssssseseeressssss 22 Table 2 Tool bar buttons and functions vweemennnnnannannnnnnewewememewa 23 Table 5 Risk Factors mandatory Tields ia 35 Tabled ADC m Orna AA 57 Table S e Troubleshoot AA aa 64 Table GAEO INE SSAC AA hieatuand E tates 65 Table 7 sS PECL ICALION GS eost vea pasvo scende satelite a a ea 70 EndoPAT 2000 vii Operation Manual Itamar Medical Ltd 1 General Information This manual is part of the Endo PAT 2000 system 1 4 Intended Use of the Endo PAT 2000 Device The Endo PAT 2000 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 Endo PAT 2000 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 Endo PAT 2000 device is not intended for use as a screening test in the general patient population It is intended to supplement not substitute the physicia
14. not selected The registration request was done on a different computer or change of hard disk The license file has expired All the capabilities enabled by the license will not work anymore Multiple deflates before inflate Make sure the probes are not touched by other fingers that they are not rested on any surface and that the tube between the probe and foam anchor is not rested on the back of the hand If the probe is in touch with the foam anchor on the adjacent finger you should either remove the foam anchor and trim its side on the diagonal so it will not touch the probe or alternatively place the foam anchor on the little finger and place a thin piece of rolled gauze as a separator between the test finger and the adjacent finger securing it in place with some medical tape Deflate manually by pressing the deflate button on the Endo PAT 2000 device If you were in Stand By mode did not press Go you should retest the patient It is recommended to wait for an hour and switch the test arm before retesting If you pressed Go make sure the study was recorded properly by opening it for analysis Refer to section 4 4 item 6 and Figure 17 Redo the registration process and replace the license lic file Contact Itamar Medical customer support Redo the registration process and replace the license lic file Verify proper connection of both tubes and probes Deflate once from the software interface or
15. option in the Test Analysis pull down menu or click the icon The report will be exported to a picture viewer it will take a few seconds There are several pages in the Report The first page contains data about the patient the study traces of the signals and the basic results RHI LnRHI and HR The second page is Risk Factor page when the risk score is calculated It contains information about the selected Risk Factor method the patient information used in the calculation the Risk Factor result and the expected change in Risk with age The 3 and 4 pages contain data about the Augmentation Index and Hart Rate Variability HRV and will only be included in the report when these features are included in the license file and calculated This report can be printed or exported to other formats i e PDF EndoPAT 2000 Device 49 Operation Manual Itamar Medical Ltd 7 4 EndoPAT 2000 study results 7 4 1 EndoScore result RHI and LnRHI The RHI Reactive Hyperemia Index is the post to pre occlusion PAT signal ratio in the occluded arm relative to the same ratio in the control arm corrected for baseline vascular tone of the occluded arm where Normal RHI gt 1 67 Abnormal RHI lt 1 67 This index and threshold were used in the validation study presented at section 1 2 of this manual and they reflect endothelial function The LnRHI is a natural log transformation of the same index where Normal LnRHI gt 0 51
16. using the button on top of the device then inflate Table 5 Troubleshooting 64 Operation Manual Itamar Medical Ltd The following table provides a list of system error messages that the user may encounter when attempting to run 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 However some errors have no user corrective actions that can remedy these situations All error messages indicate that the system could not complete the analysis of the study Unable to open file n The system cannot open the file The code in parenthesis 71 provides additional information for technical support call Itamar Signal Length Less Than Minimum Required The recorded signal length is less than the minimum required to run an analysis 6 min Signal Length More Than Maximum Allowed The recorded signal length is more than the maximum allowed to run an analysis 150 min Signal is too noisy Noisy signal prevents proper operation of the analysis module Allocation Problem Internal system failure call Itamar 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 Time too long Post Occlusion duration is shorter than minimum required Undefined occlusion Poor Occlusion Quali
17. 5 EndoPAT 2000 Device 33 Operation Manual Itamar Medical Ltd e There are 3 possible methods for calculating the Cardiovascular Risk Framingham Risk Score SCORE Risk and Reynolds Risk Score e The default method is set in the setup see 4 4 but it can be changed from patient to patient e A List of required parameters per calculation method can be found in Table 3 Mandatory fields are marked in red on the screen per selected method e A warning will appear once patient information dialog is closed if any of the mandatory fields is left blank Calculated risk result in the report will not be available in such case Required in Parameter remark Framingham SCORE Reynolds Reynolds and Framingham doesn t support diabetic patients the risk will be calculated only if positively indicating the patient is not diabetic All methods fit primary prevention Risk will not be calculated for patients with CVD Either of the patient s parent had a heart attack before they reached the age of 60 Low risk countries include Belgium France Greece Italy Luxemburg Spain Switzerland and Portugal Use high risk option to other countries in EndoPAT 2000 Device 34 Operation Manual Itamar Medical Ltd Taken from the patient information main dialog box Table 3 Risk Factors mandatory fields Gray lines represent inputs that are used in the calculation of the Risk but are part of the main Patient Info
18. Criteria for exclusion EndoPAT 2000 Device 2 Operation Manual Itamar Medical Ltd e Deformities of fingers that preclude adequate signal acquisition with the Endo PAT 2000 device e 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 5 Equipment Classification The Endo PAT 2000 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 According to IEC 60601 1 UL 60601 1 Endo PAT 2000 device is classified as Class IIa medical device 1 4 Manufacturers Notice The information in this document 1s 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 e Only qualified medical personnel may authorize the use of the Endo PAT 2000 device e Inthe event of equipment malfunct
19. Endo PAT study is entirely at the discretion of the patient s physician and 1s generally based upon the following criteria e Symptoms and complaints e Medical history e Risk factors e Current medications e Restrictions on use Section 1 5 6 1 2 System warm up The system should be turned on and allowed to warm up for at least 20 minutes before commencing patients studies It is recommended that the system would not be turned off until the last study for the day has been completed 6 1 3 Pre study adaptation period Thermoneutral room temperature must be maintained at all times 21 C 24 C 70 F 75 F Any restrictive clothing that could interfere with blood flow to the arms should be removed Heavy coats or clothes with thick sleeves should not be worn Watches or rings or other jewelry on the hands and fingers should be removed The upper arm blood pressure cuff should be applied snuggly but without excess pressure which might hamper venous blood return causing venous pooling in the arm which is deleterious to the test performed EndoPAT 2000 Device 36 Operation Manual 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 6 1 4 Patient blood pressure measurement The blood pressure measurement procedure may affect
20. USB to RS232 driver as described in section 3 5 EndoPAT 2000 Device 14 Operation Manual Itamar Medical Ltd 3 5 Installing the RS 232 to USB adaptor The RS 232 to USB adaptor connects the Endo PAT 2000 device to the computer s USB port The adapter kit contains the adapter and a software installation CD with the appropriate drivers for Windows XP Windows 7 or Windows 8 OS The installation process depends on your computer s operating system Please refer to Appendix C for instructions on how to install the driver on Windows XP or to Appendix D for instructions on how to install the driver on Windows 7 or Windows 8 OS 3 5 1 General instruction for installing the driver a The driver installation must be done before connecting the RS 232 to USB adaptor to the computer b Insert the CD into the CD ROM drive c Browse into the CD ROM drive D Your OSSSETUP d Execute the Driver s exe file e Continue the installation process by clicking next until installation ends Note Restart your computer after installation of the Endo PAT 2000 software and the RS 232 to USB adaptor driver After computer restart connect the adaptor to computer s USB port and wait for new hardware recognition by the operating system When the adaptor installation is completed start the Endo PAT 2000 software refer to section 4 The software will search for the appropriate communication port to communicate with the connected RS 232 to US
21. Using the Timer Countdown Clock 29 EndoPAT 2000 ili Operation Manual Itamar Medical Ltd 4 6 Setting the Default Printer wivicceccceccccceiwecsvceiweriecceeitecccewenscceewetecsteniteaceen 29 5 Preparing for a Study ssss sssssmasusuzunuazunzsnanusunzanaanzananza 30 5 1 Preparing the System for a Study eese 30 5 2 Connecting the PAT Probe 2 2 3cccai cups eoo e cope eor sr o aar ooa o eoa ocius 30 5 3 Creating a Patient QI UR 31 6 Conducting an Endo PAT 2000 Study e 36 6 1 PGS LUNGS Gen crisis dude cade E 36 6 2 Patient and System Setup Leere e cree Leere re ere errare 38 6 3 Pertormunp the S00 YA AAH 40 7 Review and Analysis swsssmsnananananununununzanananananananananzunua 46 7 1 Study Data Retrieval ice oeseices veu sanc sese ses onec uou es eco eue race aaan 46 7 2 Automatic Analysis 8 22 50 8 0 0 0 00 2 eae 46 7 3 Study REPOTI me M 49 7 4 Endo PAT 2000 study results eere anena 50 7 5 Cardiovascular RISK 5i ones on e eua sone uua on xo censu E cua A DRE Ins ree aDeEE Eu 52 7 6 Additional Research Features e eeeeeee eere eere e enne 53 7 7 t 56 7 8 Bateli Analysls AA USE EENEENERUN UR FEES EEMRUNERYIMAEKUREEM UIN EEME EUER UNUS EUER AAA 5
22. WITH THE REPORTING REGULATIONS OF ANY GOVERNMENTAL OR REGULATORY AGENCY 2 4 RESTRICTIONS ON USE Any use of the Licensed Software and or Licensed Product other than as set forth in Sections 2 1 and 2 2 above in each case as limited by Section 2 3 above 1s strictly forbidden Without derogating from the generality of the above you may not e Distribute reproduce copy assign rent lease or otherwise transfer the rights granted to you under this License Agreement to any third party except explicitly as set forth in this License Agreement e Reverse engineer decompile or disassemble as applicable the Licensed Software or the Licensed Product except as expressly permitted by applicable law or e Modify in any manner the Licensed Software and or the Licensed Product unless obtaining the prior written consent of Itamar 3 TRADEMARKS Cardio PAT Endo PAT 2000 PAT Probe and all trademarks and logos which appear on or in connection with the Licensed Software and or the Licensed Products as may be amended from time to time are unless stated otherwise trademarks of Itamar No right license or interest to such trademarks are generated or granted hereunder other than the limited right to use provided herein and you agree that no such right license or interest shall be asserted by you with respect to such trademarks You may not remove or destroy any copyright trademark logo or other proprietary marking or legend placed on o
23. forms a loop from the probe reaching half of the palm and back to the anchor and attached to the anchor with the integral clip as shown in Figure 30 3 Gently tape the tube to the tip of the anchor finger over the finger nail Figure 30 4 The patient should be instructed to refrain from moving the fingers to the extent possible Both patients forearms should be supported on the arm supports alternatively rolled towels or bed sheets can be used Make sure that the probes are free and not in contact with any object including the supporting surface as shown in Figure 31 EndoPAT 2000 Device 30 Operation Manual Itamar Medical Ltd Figure 31 Hands set up 6 3 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 l Click the Stand By lH icon from the main screen The system will display the signals from the two PAT channels allowing the user to check the signals and adjust the signal gain scaling to properly visualize the PAT signals without saturating the screen It is recommended to view the signal in a 1 minute screen 00 01 00 Signals from both PAT channels Probe 1 and Probe 2 appear in the Trace Window as well as the trend channels if these are selected in the system setup Visually inspect the PAT signal see Figure 32 for at least 1 minute If the sig
24. manual options described in this chapter To Mark a Segment 1 In the Trace Window position the mouse s cursor at the beginning of an interval to be marked 2 Drag the cursor horizontally along the interval the selected segment becomes highlighted 3 Release the mouse button at the end of the desired interval the selected segment remains highlighted nda PAT2000 Ciamar TTE PARET DTE ORI 7T EmONTH S 372 Fie PAT Cortrol Test Anais Help w w ojeje a c 3 l aa a roa hates Merca tel Endo PAT 200 Time Test Baseline Baseline Test ratio segment Segment Figure 45 Marking Segments and Artifacts 4 Set the highlighted segment to B T or artifact as appropriate EndoPAT 2000 Device 50 Operation Manual Itamar Medical Ltd Select a segment and click Ll icon to mark it as the B segment B segment traces are highlighted in green Select a segment and click on the bat icon to mark it as a T segment T segment traces are highlighted in red Select segments suspected as artifacts and click on the int icon to mark as an artifact segment multiple segments can be selected artifact segment traces are highlighted in yellow These segments marked in yellow are not used in the calculation process Marked segments remain highlighted in the Trace Window Figure 45 NOTE If there are noise artifacts in the region of interest in the signal you should first
25. the dialog and allow filling the dialog in preparation for the next recording NOTE All text fields ID visit patient name comments user fields and PATographer should be entered using text letters and numbers EndoPAT 2000 Device 32 Operation Manual Itamar Medical Ltd Patient Information x Patient ID Visit Patient Name Cancel Gender Age C Male Female Risk Factors m Blood Pressure mmHg New Patient Height cm Systolic 40 250 Weight Kg Diastolic 20 200 Comments User Field 1 User Field 2 Temp Nails PAT ographer m Figure 26 Patient information dialog box metric version NOTE Study data is saved in a data file that 1s automatically named with the Patient ID and Visit If the patient ID is for example 12345 and the visit is V1 then the file name will be 12345 V1 s32 NOTE The computer s file system will not allow the same Patient ID and Visit for 2 different PAT studies When attempting to use existing ID and Visit numbers the following message appears Endo_pat 7000 X 1 ID already exists 5 Enter a new ID Figure 27 File ID exists warning message A different ID or Visit must be entered before you can proceed 3 Risk Factors The Risk Factors dialog box enables entering additional data to be used in the calculation of Cardiovascular Risk For more details about the different Risk calculations see section 7
26. use be free from defects in materials and workmanship and will perform substantially as it is intended to perform If during such ninety 90 day period the Licensed Software has a defect in materials or workmanship or does not perform substantially as it is intended to perform Itamar shall a attempt to correct or assist you around errors with efforts which Itamar believes suitable to the problem b replace the Licensed Software with a functionally equivalent software or c issue a credit for the purchase price of the Licensed Software with the choice to correct or assist replace or credit being within the sole discretion of Itamar The foregoing correct or assist replacement or credit remedy will be your sole remedy for breach of the warranty set forth in this Section 4 c d Limitation of Warranties The warranties contained in Sections 4 b and 4 c above do not cover damage to the Licensed Products or the Licensed Software caused by accident misuse abuse negligence failure to install in accordance with Itamar s installation instructions failure to operate under conditions of normal use and in accordance with the terms of the documentation accompanying the Licensed Product and or the Licensed Software failure to maintain in accordance with applicable documentation accompanying the Licensed Product and or the Licensed Software alteration or any defects not related to materials or workmanship or in the case of Licensed Products des
27. will run on all the files in the selected folder Once completed a table will open automatically containing all the analysis parameters as described in Table 4 for all the analyzed files 7 9 Manual Analysis Manual Research Mode only NOTE Since the manual analysis T B does not incorporate certain mandatory features of the automatic analysis e g contra lateral arm correction and base line correction it can serve for research purposes only not necessarily endothelial dysfunction applications NOTE To enable the Manual Analysis functions it is necessary to enable the Manual Research Mode Refer to section 4 4 7 9 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 M traces recorded at different time segments This feature can define any number of time intervals as artifacts and thereby exclude them from the ratio calculations You can mark segments in the Trace Window identifying two segment types later to be used in calculations e B Baseline segment e T Test segment EndoPAT 2000 Device 58 Operation Manual Itamar Medical Ltd NOTE While marking segments and artifacts errors may be corrected by clicking the EA icon Clear all segments This will also erase the occlusion border markings This tool should be used only when using the
28. 0 Windows Driver on Your Computer Click Install to continue with the installation ar click Back if vou want to review or change any settings Destination location m C Program Files aga L IS BDrrver Figure 47 MOXA USB Installation XP1 EndoPAT 2000 Device 78 Operation Manual Itamar Medical Ltd 1 6 Click Install 1 7 The following screen 1s displayed Software Installation A The software you are installing has not passed Windows Logo testing to very its compatibility with Windows XP Tell me why this testing i Important Continuing your installation of this software may impair or destabilize the correct operation of your system either immediately or in the future Microsoft strongly recommends that you stop this installation now and contact the software vendor for software that has passed Windows Logo testing Continue Anyway TR Figure 48 MOXA USB Installation XP2 1 8 Click Continue Anyway you need to approve this warning twice The following screen is displayed ie Setup MOXA UPort 1110 1130 Windows Driver Completing the MOXA UPort 1110 1130 Windows Driver Setup Wizard Setup has finished installing MOMMA UPort 1110 1130 Windows Driver on pour computer Click Finish to exit Setup Finish Figure 49 MOXA USB Installation XP3 1 9 Click Finish EndoPAT 2000 Device 79 Operation Manual Itamar Medical Ltd
29. 579 5 Beaumont Gate Shenley Hill Caesarea Ind Park 3088900 Israel Radlett HertfordshireWD7 7AR Tel 972 4 6177000 England Fax 972 4 6275598 Tel 44 20 8128 8056 www itamar medical com Tel Fax 44 1923859810 www itamar medical com images licenseep pdf EndoPAT 2000 Device 69 Operation Manual Itamar Medical Ltd 10 5 Specifications for Endo PAT 2000 system PAT Probe Itamar s proprietary probe only Recording Time Limited by hard disk space 8MB per study of 20 minutes PATI Channel Selective Gain Selectable Time Base Power Supply _ input Gen Linn Storage Transportation Device Transportation Probes Humidity Operating amp Storage 10 95 non condensing Dimensions Lx WxH max 240mm x 135 mm x 185 mm Table 7 Specifications EndoPAT 2000 Device 70 Operation Manual Itamar Medical Ltd Appendix A License Agreement and Limited Warranty License to User from Itamar IMPORTANT PLEASE READ THIS LICENSE AGREEMENT CAREFULLY BEFORE INSTALLING OR OTHERWISE USING THE LICENSED SOFTWARE AS DEFINED BELOW OR THE PRODUCT WITH WHICH YOU RECEIVED THIS LICENSE AGREEMENT THIS LICENSE AGREEMENT APPLIES TO a ALL LICENSED SOFTWARE b ALL LICENSED PRODUCTS AS DEFINED BELOW AND c ALL THIRD PARTY PRODUCTS AS DEFINED BELOW SHOULD YOU HAVE ANY QUESTIONS CONCERNING THIS LICENSE AGREEMENT PLEASE CONTACT THE VENDOR FROM WHICH YOU PURCHASED THE LICENSED SOFTWARE LICENSED PRODUCT OR
30. 8 7 9 Manual Analysis Manual Research Mode only 58 AMO TSCM Py UMN AAA 61 7 11 Uploading data to the server eere eere rere 61 8 IVE AINILOIVATIC AAA 62 8 1 Device MAIN EN ANCE 2e conica sree skin chats eoo es se euo esee susce asses eoo oia SE kusni 62 8 2 PODA WA mes 62 9 Troubleshooting ssssssamananunununzananananananananunuzzananananananua 63 10 Technical Informations scssetascsstauierccacinetewsanvacsaidageumeaeesaend 66 10 1 System Minimum Requirements 0 0sseeseeseeeceeeeesenseneensensensenseneees 66 10 2 OPERATING SVStelilbzsssxexsknsRAAMRNRRERERUDREREEFERRSERIEFOSNERSKENS E EENFEEREREREREEERSNIRNEYE 66 EndoPAT 2000 iv Operation Manual Itamar Medical Ltd 10 3 Technical information about labeling 66 104 Ecl rdi 68 10 5 Specifications for Endo PAT 2000 system ee eren TO Appendix A License Agreement and Limited Warranty T1 Appendix B Regulatory Authorized Representative 77 Appendix C installing the USB adaptor for Windows XP 78 Appendix D installing the USB adapter for Windows 7 or 8 84 List of Figures Dioure le TV PIC ANS eta Debet de E E WA aa KWA WA AL 9 Figure 2 Endo PAT 2000 device tette 10 Figure 3 Connection of pneumo electric tubing and USB adaptor
31. 84 Operation Manual Itamar Medical Ltd la User Account Control Program name driv win uportlp v1 4 build 07100420 whgl exe Publisher Unknown File origin Hard drive on this computer V Show detail Change when these notifications appear Figure 59 Win7 Security 1 3 The following window will open press the Next Button isl Setup MOXA UPort 1110 1130 Windows Driver Welcome to the MOXA UPort 1110 1130 Windows Driver Setup Wizard This will install MOXA UPort 1110 1130 Windows Driver Ver1 4 on your computer It is recommended that you close all other applications before continuing Click Next to corrinus or Cancel to exit Setup Figure 60 MOXA Uport driver installation 1 4 The following window will open press the Next button Endo PAT 2000 Device 85 Operation Manual Itamar Medical Ltd i Setup MOXA UPort 1110 1130 Windows Driver Select Destination Location Where should MOA UPort 1110 71130 V ndows Dover be installed LJ Setup will install MOXA UPort 111071130 Windows Dirreer into the following folder To continue click Nest IF you would like to select a different folder click Browse Browse Cancel Figure 61 MOXA driver installation folder 1 5 The following window will open press the Install button E i Setup MOXA UPort 1110 1130 Windows Driver Ses Ready to Install Setup is now ready to begin installing MOZA UP ort 1110 71130 Win
32. APPLICABLE LAW EXCEPT FOR DAMAGES ARISING UNDER SECTION 4 A ABOVE IN NO EVENT SHALL ITAMAR BE LIABLE TO YOU FOR DAMAGES IN EXCESS OF THE PURCHASE PRICE YOU PAID FOR THE LICENSED SOFTWARE THE LICENSED PRODUCT OR THE APPLICABLE THIRD PARTY PRODUCT THE FOREGOING LIMITATION SHALL BE APPLICABLE REGARDLESS OF WHETHER THE ACTION GIVING RISE TO SUCH DAMAGES IS IN TORT CONTRACT STRICT PRODUCTS LIABILITY OR OTHERWISE B IN NO EVENT SHALL ITAMAR BE LIABLE FOR ANY SPECIAL INCIDENTAL INDIRECT OR CONSEQUENTIAL DAMAGES WHATSOEVER ARISING OUT OF OR IN ANY WAY RELATED TO THE USE OF OR INABILITY TO USE THE LICENSED SOFTWARE AND OR THE LICENSED PRODUCT AND OR THE THIRD PARTY PRODUCT OR THE PROVISION OF OR FAILURE TO PROVIDE SUPPORT SERVICES BY ITAMAR EVEN IF ITAMAR HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH CONSEQUENTIAL DAMAGES THE FOREGOING DISCLAIMER OF CONSEQUENTIAL DAMAGES SHALL BE APPLICABLE REGARDLESS OF WHETHER THE ACTION GIVING RISE TO SUCH DAMAGES IS IN TORT CONTRACT STRICT PRODUCTS LIABILITY OR OTHERWISE C IN ORDER TO BE ENTITLED TO INDEMNIFICATION HEREUNDER IN CONNECTION WITH AN INFRINGEMENT CLAIM YOU MUST i NOTIFY ITAMAR IN WRITING PROMPTLY UPON BECOMING AWARE OF AN INFRINGEMENT CLAIM OR THE POSSIBILITY THEREOF ii GRANT ITAMAR SOLE CONTROL OF THE SETTLEMENT COMPROMISE NEGOTIATION AND DEFENSE OF ANY SUCH ACTION AND iii PROVIDE ITAMAR WITH ALL INFORMATION RELATED TO THE ACTION THAT IS REASONABLY REQUESTED BY ITAMAR NOTWI
33. B adaptor as described in section 5 1 Note Refer to the configuration section Section 4 4 for changing automatic COM port configuration 3 6 Registration Once the software and driver are installed the system is ready for use in its basic configuration EndoPAT 2000 Device 15 Operation Manual Itamar Medical Ltd Itamar Medical strongly recommends that you register your EndoPAT software installation Registration enables you to benefit from our special offers when available and to be able to activate some of our newer features Registration enables Itamar Medical to notify you when new version of your product is available and helps Itamar Medical provide you with customer support To register the software installation you first need to create a registration request file Use the following instructions to create registration file and register your installation 3 6 1 Open the registration window from the PAT Control menu select Registration Inflate beHate Shop Standby fan Start Timer Reset Timer Probes Information Setup Registration Figure 9 Registration EndoPAT 2000 Device 16 Operation Manual Itamar Medical Ltd 3 6 2 The following dialog will be opened Registration E x We strongly recommend that you register your EndoPAT software installation Registration enables you to benefit from our special offers when available and to be able to activate some of our
34. Itamar medical EndoPAT 2000 Device User Manual Itamar Medical OM1695214 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 Caution Federal U S law restricts this device to sale by or on the order of a physician Copyright 2002 2014 by Itamar Medical Ltd Software Version 3 5 x Itamar Medical Ltd This manual and the information contained herein are confidential and are the sole property of M Tamar 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 ENDO PAT 2000 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 Itamar Medical Ltd 9 Ha
35. Ltd NOTE It is recommended to change the time base to a 1 minute screen 00 01 00 to make the identification of the occlusion borders easier If the occlusion area extends beyond the edge of the window the window will automatically scroll as you drag the mouse across its edge e The designated occluded probe is marked on screen by the blue text Occlusion duration under the Probe label on the left side of the screen The occluded probe is selected automatically by the software It can be changed by right clicking on the mouse anywhere in the signal window and selecting the correct occluded probe Figure 37 e Once the manually selected occlusion is marked click on the A icon to run the automatic analysis using the manually selected occlusion area e The manual changes of the occlusion borders can be saved by selecting the Save option from the File menu These changes will be recorded into a file with an M32 suffix rather than the original raw data which will have the same file name but an S32 suffix for example johnSmith S32 amp johnSmith M32 The M32 files are 1KB in size and only contain coordinates of the occlusion borders NOTE manual changes of the occlusion borders are automatically saved e To remove the manually added occlusion markings right click on the mouse and select Clear Occlusion Figure 37 7 3 Study Report To review the study report select the View report
36. O COM cable to the Endo PAT 2000 device and tightly screw the bolts Figure 66 connect COM TO COM 3 3 Open the Endo PAT 2000 software and verify that the PAT indicator on the bottom right is colored green Endo PAT 2000 Device 89 Operation Manual
37. THIRD PARTY PRODUCT YOU MAY ALSO CONTACT ITAMAR AT THE ADDRESS PROVIDED AT THE END OF THIS LICENSE AGREEMENT This License Agreement is a legal agreement between you as an individual company organization or other entity and Itamar Medical Ltd Itamar By installing copying or otherwise using the Licensed Software and or by using the Licensed Product or any Third Party Product you agree to be bound by the terms of this License Agreement with respect to the Licensed Software and Licensed Products If you do not agree to the terms of this License Agreement INCLUDING WITHOUT LIMITATION THE LIMITATIONS ON USE AS PROVIDED IN SECTION 3 3 AND THE RESTRICTIONS ON USE AS PROVIDED IN SECTION 3 4 do not install use or copy the Licensed Software or use the Licensed Product or the Third Party Product For the avoidance of doubt in the event that you have entered into an agreement in writing Subsequent Agreement with Itamar covering the subject matter of this license then to the extent that any terms or provisions of such Subsequent Agreement are in conflict with different than or additive to the terms and provisions of this license such terms and provisions of such Subsequent Agreement shall prevail The Licensed Software and the Licensed Products are protected by US patent laws trade secret laws copyright laws and international treaty provisions as well as other intellectual property laws and treaties Therefore you must treat the L
38. THSTANDING THE FOREGOING ITAMAR SHALL HAVE NO INDEMNIFICATION OBLIGATIONS WITH RESPECT TO ANY INFRINGEMENT CLAIM TO THE EXTENT ARISING FROM YOUR USE OF THE LICENSED PRODUCT AND OR LICENSED SOFTWARE IN CONJUNCTION WITH OTHER HARDWARE OR SOFTWARE WHERE USE WITH SUCH OTHER HARDWARE OR SOFTWARE GAVE RISE TO THE INFRINGEMENT CLAIM 6 TERMINATION Without prejudice to any other rights or remedies Itamar may terminate this License Agreement immediately if you fail to comply with any of its terms and conditions In the event of such termination you must within ten 10 business days of receiving notice of EndoPAT 2000 Device 75 Operation Manual Itamar Medical Ltd termination from Itamar cease all use of the Licensed Software and destroy all copies thereof and cease all use of the Licensed Product including Licensed Product incorporated within Third Party Product 7 TRANSFERABILITY You may only transfer or assign the rights and obligations hereunder together with the Licensed Software and or the Licensed Product or Third Party Product as a whole without retaining any rights or subject to Sections 2 and 3 above any obligations arising after the date of such transfer or assignment or retaining any installed or uninstalled copy of the Licensed Software the Licensed Product or the Third Party Product Any attempt by you to rent lease sublicense assign or transfer any of the rights duties or obligations hereunder in any other way is
39. 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 Endo PAT 2000 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 phases e Real time recording and display e Off line display and analysis Since the system records data in real time it 1s possible to follow events as they occur Data acquired during a study 1s automatically stored to the computer s hard disk and may subsequently be retrieved for off line review and automatic analysis 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 EndoPAT 2000 Device 8 Operation Manual Itamar Medical Ltd 3 Installing the System 3 1 Basic System Configuration The Endo PAT 2000 device is supplied as a complete packag
40. anual Itamar Medical Ltd available in the tabular report Excel or HTML and in the patient report as the last page which includes also some graphical results See Figure 43and Figure 44 for the information presented in the report Mean MM 1096 ms SONN 91 22 ms RMSSD 90 13 mis NMS0 49 pNINSL 17 85 96 Triangular Index 18 57 Poincare Overview Poincare MEI Interval Distribution T 1800 mm l meres EID T zum 1600 M T HT E ut 3000 TIL Ii es ee 1400 T o du ieni ES C oy EE PETET n NUM P z 1200 SUUS lo CN E 3 1000 n Ji ann x NT TT IM M 500 1000 1500 2000 800 10001200 140016001800 NM ms MM Figure 43 Time domain HRV in the report LF 0 04 0 15 Hz 220 43ms HF 0 15 0 4 Hz 164 60mg LF HF 1 34 Power spectrum HF Figure 44 Frequency domain HRV in the report 7 6 3 FRHI The Endo PAT device has been used in the Framingham Heart Studies for several years 2008 Circulation 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 Endo PAT device termed here as FRHI Basically it is a natural log transform of the ratio between the post to pre occluded PAT amplitudes and the same ratio of the PAT amplitudes measured at the control arm FRHI does not incorporate a correction to the baseline and is using short
41. ation 0 7 marked in blue and the dichotomy threshold for normal endothelial function 0 51 marked in red are presented as vertical lines on the graph The individual EndoScore result of the patient is presented on this graph bold black line and a result frame to aid assess the patient condition in respect to the dichotomous threshold and the general population In case that Endothelial 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 next to the LnRHI values in the graph 7 4 2 Heart Rate The HR Heart Rate is calculated from the PAT signals in the baseline region of interest EndoPAT 2000 Device 51 Operation Manual Itamar Medical Ltd 7 5 Cardiovascular Risk EndoPAT software enables the calculation of 3 types of Cardiovascular Risk The software uses the information entered in the patient dialog box and calculates the selected Risk The result appears in the report and in the tabular report 7 5 1 Framingham Risk Score Framingham Risk Score estimates the risk of developing hard CHD adverse events myocardial infarction or coronary death over a course of 10 years Adults Treatment Panel III JAMA 2001 The risk is given in percentages The Framingham Risk Score applies only to people without known heart disease or diabetes For more information visit http
42. dows Driver on your Computer Click Install to continue with the installation or click Back if you want to review or change any settings Destination location C Program Filezsldoxa sl IS BDrver Cancel Figure 62 MOXA driver folder confirmation 1 6 Press the Finish button EndoPAT 2000 Device 86 Operation Manual Itamar Medical Ltd Completing the MOXA UPort 1110 1130 Windows Driver Setup Wizard Setup has finished installing MOXA UFort 1110 1130 Windows Diner on your computer Click Finish to ext Setup Figure 63 MOXA driver installation finish 2 Configuring the MOXA Adapter 2 Plug in the adapter to your USB port Figure 64 The MOXA Adapter 2 2 The following icon should appear at the window notification area zone while windows installs the driver needed for the MOXA adapter this is done automatically EndoPAT 2000 Device 87 Operation Manual Itamar Medical Ltd Installing device driver software Click here For status 2 3 When the installation of the driver is done the following message should appear IL Your devices are ready to use J Device driver software installed successfully EndoPAT 2000 Device 88 Operation Manual Itamar Medical Ltd 3 Connecting the adapter to the Endo PAT 2000 device 3 1 Connect the MOXA Adapter to the COM TO COM cable and tightly screw the bolts z n MER MC c lt Figure 65 connect MOXA adaptor 3 2 Connect the COM T
43. e 61 Operation Manual Itamar Medical Ltd 8 Maintenance 8 1 Device maintenance This chapter describes preventive and regular maintenance for the Endo PAT 2000 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 1 Inspect all cords and ensure they are not frayed or damaged Verify that all plugs connectors and cables are securely connected 2 The Endo PAT 2000 device should be free of dirt and debris Using a soft slightly damp cloth gently wipe the exterior of the Endo PAT 2000 device avoiding contact with open vents and plugs 3 Used probes should be discarded after each use and replaced with new ones 4 Refer to the Endo PAT 2000 Service Manual for additional information and spare parts list 8 2 Probe data Probes information Serial Number Production batch number and Status used not used can be received by selecting Probes Information option from the PAT Control menu when the device is connected and the probes are attached to tubes The following screen will appear with the probes information Probes Information X Probet Serial Number 15 Batch Number 115 Clear Used Status
44. e comprising the following components e One Endo PAT 2000 device e One EndoPAT 2000 software CD e Two pneumo electric tubing e Power adaptor e Power cable e Operation manual e Set of 6 foam finger anchors e USB adaptor The supplied Endo PAT 2000 software package can be used with any Windows computer running English versions of Windows XP Windows 7 or Windows 8 The automatic analysis module requires any type of internet browser or Excel 2000 or newer For details regarding hardware and software requirements refer to System Requirements in Section 10 1 Although individual system set Figure 1 Typical set up ups may vary Figure 1 represents a typical setup of a study EndoPAT 2000 Device 9 Operation Manual Itamar Medical Ltd 3 2 System description The Endo PAT 2000 device top panel has e Power LED indicator e LED indicator for the device computer communication status e Probe s Deflate and Inflate buttons Power LED Indicator Power Supply Communication DC Connector LED Indicator USB to COM Inflate Button adaptor Deflate Button ON OFF Switch The front panel has two pneumatic input connectors for attaching the pneumo electric tubing connecting the PAT probes to the Endo PAT 2000 device The back panel has Figure 2 Figure 2 Endo PAT 2000 device e Power supply DC connector e Communication port e ON OFF switch EndoPAT 2000 Device 10 Operation Manual
45. ected to serial port above COM10 then please select Work Disconnected and set COM port manually through Setup Dialog Figure 21 COM port search 5 2 Connecting the PAT Probe Connect two new probes by inserting the connector tab into each probe slit see Figure 22 and pressing the connector down onto the probe until the tab of the probe clicks into place see Figure 23 EndoPAT 2000 Device 30 Operation Manual Itamar Medical Ltd Figure 22 Inserting into slit Figure 23 Clicking in To remove probes press the tab clip marked by the arrow in Figure 24 and then lift the connector away from the probe Figure 25 Used probes should be disposed of properly Figure 24 Press to release Figure 25 Probe disconnected 5 3 Creating a Patient File Click the ie icon on the tool bar or activate from the Test Analysis menu the Patient Information dialog box See Figure 26 2 All mandatory fields are highlighted in red and must be filled in order to proceed to the next step The field description is as follows e Patient ID Enter patient identification number mandatory field EndoPAT 2000 Device 31 Operation Manual Itamar Medical Ltd e Visit Enter visit number or code Up to 9 characters This field should be used to distinguish between several tests by the same patient with the same ID The patient ID and visit are used to generate the file name used by the system e Patient First and Last name
46. ection 4 4 Endo PAT 2000 Figure 13 Fill site name dialog box Upon first launching the system will also display a Registration reminder message Figure 14 This reminder will appear as long as there is no license file and as long as this reminder was not turned off in setup screen For more information about the need of license file see section 3 6 For more information about turning this reminder off see section 4 4 Endo PAT2000 X AN Please Register EndoP4T2000 application Figure 14 Registration reminder EndoPAT 2000 Device 21 Operation Manual Itamar Medical Ltd 4 2 Main Screen Menu Commands Table 1 describes the main screen pull down menu commands PAT Control Test Analysis Open a previously saved study Save study data Print screen Exit the Endo PAT 2000 Software Inflate PAT probes Deflate PAT probes Stop a study Standby mode view signals without recording GO Start recording a study Start Timer Reset Timer Probes Information Setup parameters Registration Open Patient Information dialog box Automatic Analysis Select occlusion period Select Baseline Segment in Manual Research mode only Select Test Segment in Manual Research mode only Mark segment as artifact in Manual Research mode only Clear all marked segments Zoom In View report Open Batch Analysis dialog box Provides access to system information Link to Itamar Medical Uploading Se
47. ency domain HRV in the report eeeeeeeeeeeeee 55 Figure 45 Marking Segments and Artifacts eese 59 Fiure 46 Probes InfOPthablOTE usns n a E EE 62 Figure 47 MOXA USB Installation KPI ou eeeesseseeeeescccececeecccccceeeeeesssessees 78 Figure 48 MOXA USB Installation XP2 2 nebst ER eet Eee pev eode 79 Figure 49 MOXA USB Installation XP3 e eeeeeeeeeeeeeeee eene eene entren 79 Fieure 50 MONA A UIDIGE esis db ode Er eoa 0 S usd tma ei 80 Figure 51 MOXA Adapter Configuration XP2 ccccsssssscccccccccccceceeeeeessssseseees 80 Figure 52 MOXA Adapter Configuration XP3 seen 81 EndoPAT 2000 vi Operation Manual Itamar Medical Ltd Figure 53 MOXA Adapter Configuration XPA sese 81 Figure 54 MOXA Adapter Configuration XP5 sse 82 Figure 55 MOXA Adapter Configuration XPO sss 82 Fieure 6 connect MON Ac Adai AA 83 Fiure o7 connect C ONE TO COM Aa 83 Fiure So WINS ia wa 84 Poue WA C U a E N A 85 Figure 60 MOXA Uport driver installation sse 85 Figure 61 MOXA driver installation folder eese 86 Figure 62 MOXA driver folder confirmation sees 86 Figure 63 MOXA driver installation finish eese 87 Lieuic 604 The MOXA MAA 87 Fisure oS connect MOX A CQUADIOE creio a A EEE 89 Figure 60
48. ense Agreement applies to the Licensed Software 1 3 Third Party Product means any product into which a Licensed Product or Licensed Software is incorporated 2 LICENSE TO USE LIMITATIONS AND RESTRICTIONS ON USE 2 1 LICENSE TO USE LICENSED SOFTWARE Itamar hereby grants you a non exclusive right to use the Licensed Software 1 solely with the Licensed Product s and 11 solely for its 1ntended use in testing of endothelial function 1n accordance with the provisions of this License Agreement and the instructions provided in the documentation accompanying the Licensed Software and the Licensed Product subject to the Limitations on Use as provided in Section 3 3 and the Restrictions on Use as provided in Section 3 4 You may make one copy of the Licensed Software solely for backup or archival purposes or transfer the Licensed Software to a single hard disk provided you keep the original solely for backup or archival purposes However you may not cause any Licensed Software which is not designed for use on a server to execute or be loaded into the active memory or media of more than one computer at any one time 2 2 LICENSE TO USE LICENSED PRODUCTS Itamar hereby grants you a non exclusive right to use the Licensed Product s 1 solely with the Licensed Software and 11 solely for its intended use in testing of endothelial function in accordance with the provisions of this License Agreement and the instructions provided in the docum
49. entation accompanying the Licensed Software and the Licensed Product subject to the Limitations on Use as provided in Section 3 3 and the Restrictions on Use as provided in Section 3 4 2 3 LIMITATIONS ON USE The licenses granted in Sections 2 1 and 2 2 above are for use in normal medical practice and you are not licensed or authorized to include or use in any manner or to provide to any third party for such inclusion or use any test results derived from the Endo PAT 2000 device and or the Endo PAT Software for the purpose of seeking or obtaining any regulatory approval from any governmental or EndoPAT 2000 Device 72 Operation Manual Itamar Medical Ltd regulatory agency of any diagnostic or therapeutic claim or medical device pharmaceutical or other therapeutic or diagnostic product Without derogating from the generality of the foregoing the inclusion by you or any third party of any results of any type derived through the use of the Endo PAT 2000 device and or the Endo PAT Software in any regulatory filing for the purpose of supporting or obtaining any such approval without the prior written consent of Itamar is expressly prohibited THIS LIMITATION REFERS SOLELY TO THE SEEKING OR OBTAINING OF DIAGNOSTIC OR THERAPEUTIC CLAIMS AND NOTHING IN THIS AGREEMENT INCLUDING THIS LIMITATION ON USE IS INTENDED IN ANY MANNER TO RESTRICT THE REPORTING OF INFORMATION REGARDING THE ETT PAT2000 AND OR THE ETT PAT SOFTWARE IN ACCORDANCE
50. er post occlusion times 1 5 2minutes than the RHI LnRHI Researchers that want to use this index for research purposes can ask Itamar Medical to enable this index as part of the registration process The FRHI will be added to the tabular report see Table 4 EndoPAT 2000 Device 55 Operation Manual Itamar Medical Ltd 7 7 Tabular Report Click the icon to get tabular report The table lists relevant study parameters and results for all analyses performed to date with the last line in the table containing data from the most recent analysis performed Table 4 is a description of the information fields displayed in the table NOTE Please note that the Endo PAT analysis of Augmentation Index AD Heart Rate Variability HRV and FRHI are not FDA cleared and can be applied for clinical use out of the US only EndoPAT 2000 Device 56 Operation Manual Itamar Medical Ltd bom Al N pulses number of pulses averaged to calculate the Al Al P1 L W rrors Baseline duration region of interest ROI duration and total study duration MeanBL o Mean PAT signal amplitude in the baseline region of interest value for N the occluded side suffix o Post occlusion signal to baseline signal ratios at 14 consecutive 30 sec time AK AM 2 AO BB segments for the occluded side MeanBL c Mean PAT signal amplitude in the baseline region of interest value for C the control side suffix
51. eriodic review of the manual is recommended 5 The Endo PAT 2000 system is a whole system To eliminate risk of electrical shock do not attempt to open or remove system covers or plugs 6 Donot 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 Endo PAT 2000 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 Donotapply the probe to an infected finger or wounded skin Caution Federal law restricts this device to sale by or on the order of a physician WARNING Probes manufactured before January 2007 contain 50 micrograms or less per gram of natural rubber latex water extractable protein which may cause allergic reactions Do not use the latex probes on patients
52. forbidden and shall be null and void 8 SEVERABILITY Should any term or provision of this License Agreement be declared void or unenforceable by any court of competent jurisdiction in any country or countries such declaration shall have no effect on the remainder of this License Agreement in such country or countries or on this License Agreement in other countries 9 NO WAIVER The failure of either party to enforce any rights granted to it hereunder or to take action against the other party in the event of any breach hereunder shall not be deemed a waiver by that party as to subsequent enforcement actions in the event of future breaches 10 GOVERNING LAW AND JURISDICTION This License Agreement is governed by the laws of the State of New York excluding its conflict of laws principles The United Nations Convention on Contracts for the International Sale of Goods shall not apply to any of the transactions contemplated by this License Agreement 11 ENTIRE UNDERSTANDING This License Agreement represents the complete and exclusive understanding between you and Itamar concerning the license by Itamar to you of Licensed Software and Licensed Products and supersedes all prior agreements and representations between the parties with respect to the subject matter hereof unless specifically stated otherwise in a writing signed by Itamar and you This License Agreement may not be amended other than by a written agreement specifically intended f
53. gister You will receive a message Figure 11 directing to the location of the registration request file EndoRegistration req Endo PAT2000 E XI i To register your EndoPAT installation email the File named C YEndoPAT2000YEndoRegistration req AJ to lic itamar medical com or contact your local distributor Email rust be sent from a controlled email address as reply will be sent to that address only Once registration is approved you will receive an email with activation File and explanation how to use it Figure 11 Registration request file instructions Once you obtain your EndoRegistration req file send it to lic itamar medical com or contact your local distributor Itamar Medical will receive your request process it and you will receive the License lic file by e mail Place the license file in your installation directory and restart the Endo PAT application NOTE The License file is unique and will only enable your licensed features on the same computer generated the license request file EndoPAT 2000 Device 18 Operation Manual Itamar Medical Ltd NOTE Registration may enable you to use different probe types This will be done based on your agreement with Itamar Medical and should not be requested separately Contact Itamar Medical s representative or your local distributor for more information 3 7 Uninstalling Endo PAT 2000 Software Enter the computer s Control Panel and select the Add Remove p
54. ia such as CD R or DVD R for storage of study files Printer higher resolution preferred Color recommended 10 2 Operating System Windows XP Windows 7 Windows 8 x86 x64 10 3 Technical information about labeling Double isolation Date of manufacture Follow instructions for use Type BF applied part EndoPAT 2000 Device 66 Operation Manual Itamar Medical Ltd The product is certified by CSA 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 Temperature limit Medical device Manufacturer Catalogue Number Serial Number EndoPAT 2000 Device 67 Operation Manual Itamar Medical Ltd 10 4 Labeling Label on the base of the Endo PAT 2000 device main control unit Endo PAT 2000 Type Rev XXXXXX AS1650004 ul Itamar Medical Ltd 9 Halamish st Caesarea Industrial Park 3088900 Israel Tel 972 4 61 77000 Fax 4 9 2 4 62 5598 E mail support itamar medical com Ge 2014 ia Qa 12V DC 1A 207233 Packaging labels The following labels are attached to the master package of the Endo PAT 2000 system 1 EndoPAT 2000 Device 68 Operation Manual Itamar Medical Ltd Endo PAT 2000 Probe Package itamar meclical EndoPAT Pneumatic PAT Probe 9s LT ul Itamar Medical Ltd EC REP Medes Ltd 9 Halamish St P O Box 3
55. icensed Software and the Licensed Products like any other copyrighted and protected material or product AII title to the Licensed Software and all intellectual property rights in and to the Licensed Software and the Licensed Products shall remain with Itamar 1 Definitions 1 1 Licensed Product s means the Endo PAT 2000 devuce the PAT Probe and the corresponding components of any Third Party Product with which this License Agreement was received Some Licensed Products are stand alone products and some Licensed EndoPAT 2000 Device 71 Operation Manual Itamar Medical Ltd Products are incorporated as components within Third Party Products in each case sold or otherwise made available by Itamar and or third parties If you have received this License Agreement with a Third Party Product this License Agreement applies only to the Licensed Product incorporated as a component within such Third Party Product 1 2 Licensed Software means the Endo PAT software and the associated media and accompanying materials provided to you with such Endo PAT software Some Licensed Software is a stand alone product and some Licensed Software is incorporated as a component within a Licensed Product in each case sold or otherwise made available by Itamar and or third parties If you have received this License Agreement with a Licensed Product which incorporates the Licensed Software as a component within such Licensed Product this Lic
56. ign materials or workmanship This warranty does not cover damage which may occur in shipment This warranty does not apply to Licensed Products and or Licensed Software not purchased new This warranty does not apply to any Licensed Product or any individual parts of a Licensed Product which have been repaired or altered by anyone other than Itamar or a person or entity authorized by Itamar to repair Licensed Products While every reasonable effort has been made to ensure that you will receive Licensed Software that you can use Itamar does not warrant that the functions of the Licensed Software will meet your requirements or that the operation of the Licensed Software will be uninterrupted or error free Itamar 1s not responsible for problems caused by changes in the operating characteristics of the hardware or operating system software you are using nor for any problems in the interaction of the Licensed Software with non Itamar software ITAMAR HEREBY DISCLAIMS WITH RESPECT TO THE LICENSED PRODUCTS AND THE LICENSED SOFTWARE ALL OTHER WARRANTIES AND CONDITIONS WHETHER EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO ANY WARRANTIES OR CONDITIONS OF OR RELATED EndoPAT 2000 Device 74 Operation Manual Itamar Medical Ltd TO MERCHANTABILITY FITNESS FOR A PARTICULAR PURPOSE ACCURACY OR COMPLETENESS OF INFORMATION LACK OF NEGLIGENCE AND CORRESPONDENCE TO DESCRIPTION 5 LIMITATION OF LIABILITY A TO THE MAXIMUM EXTENT PERMITTED BY
57. ill be marked just below Probel or Probe2 on the left hand side of the screen in blue Release the mouse button In the Test Analysis menu select the Select Occlusion Period option to set the manually selected occlusion area Occlusion markers blue vertical lines can be dragged to improve the fit of the occlusion area Zoom in to fine tune the location of the occlusion markers 2 Position the mouse s cursor at the beginning of the occlusion area Right click on the mouse will open a popup menu Figure 37 Select Set Automatic 5 min Occlusion from the popup menu A five minutes segment starting at the curser position will be marked in blue Occlusion markers blue vertical lines can be dragged to improve the fit of the occlusion area Zoom in to fine tune the location of the occlusion markers 3 Position the mouse s cursor at the beginning of the occlusion Right click to open a popup menu Figure 37 Set Automatic 5 min Occlusion Set Start Occlusion Marker Set End Occlusion Marker Gecluded Probe w Occluded probez Clear Occlusion Figure 37 Occlusion Popup Menu Select Set Start Occlusion Marker Move to the location of the end of the occlusion period right click select Set End Occlusion Marker Occlusion markers blue vertical lines can be dragged to improve the fit of the occlusion area Zoom in to fine tune the location of the occlusion markers EndoPAT 2000 Device 48 Operation Manual Itamar Medical
58. ing a USB to RS232 adaptor connect the adaptor to the computer directly and not via USB hub Endo PAT 2000 Device 11 Operation Manual Itamar Medical Ltd 3 4 EndoPAT 2000 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 Endo PAT 2000 software NOTE Uninstall previous Endo PAT 2000 software versions prior to installing a newer version To uninstall the software please refer to section 3 7 Make sure to backup all your data prior to uninstalling any software 2 Insert the Endo PAT 2000 software CD into the CD drive The installation program will load automatically Alternatively you may execute the setup exe application from the installation CD 3 The Installshield wizard prepares the computer for installation When prompted click next to proceed with the installation Figure 4 fe Endo PAT2000 Setup E X Welcome to the InstallShield Wizard for Endo PAT2000 The InstallShield R Wizard will install Endo PAT2000 on your computer To continue click Next Attention A user with full administrator permissions must perform this installation if you do not have such permissions please cancel installation now
59. ion You can remove unused names by selecting a name in the bottom field and clicking Remove 14 In the Pressure control frame select whether the probe inflation pressure 1s set to a pressure that is dependent on the patient s diastolic blood pressure recommended mode or to a fixed pressure If a fixed pressure setting 1s selected the inflation pressure can be changed from the default 50mmHg NOTE If Diastolic blood pressure dependent is selected the diastolic blood pressure of the patient must be entered prior to commencing the study The study cannot start without this information 15 When all the settings are correct click OK NOTE The default inflation pressure setting for the PAT Sensors is 50 mmHg in fixed mode It is recommended that this is not exceeded unless specified otherwise EndoPAT 2000 Device 28 Operation Manual Itamar Medical Ltd NOTE Setup can be opened while recording a study however during a recording the COM field and the Pressure Control fields are disabled and cannot be modified 4 5 Using the Timer Countdown Clock Some phases in the study recording require strict timing To operate the timer refer to the following instructions e To set the timer the number of complete minutes it will count refer to the Setup menu section 4 4 e To start the timer click the co icon When the timer reaches 0 the timer indicator at the bottom right of
60. ion all repairs should be executed by authorized Itamar Medical Ltd personnel or licensed service agents e The eligibility of a patient fora PAT study is generally based upon the patient s medical status The following should not be considered for the PAT study e Deformities of the digits of the upper extremities which preclude adequate signal acquisition e Patients under the effect of short acting NTG 3 hours washout period e Patient suffering from a medical condition prohibiting blood flow occlusion in both arms If occlusion is prohibited in only one arm than 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 e The Endo PAT 2000 system in whole or in part may not be modified in any way EndoPAT 2000 Device 3 Operation Manual Itamar Medical Ltd e The device is intended for diagnostic purposes only and should not be used for monitoring e The device is not intended as a screening test in the general patient population e tamar Medical Ltd makes no representation whatsoever that the act of reading this User Manual renders the reader qualified to operate test or calibrate the system e The tracings and calculations provided by the Endo PAT 2000 system are intended as tools for the competent diagnostician They are explicitly not to be regarded as a sole incontrovertible basis for clinical diagnosis e In
61. lamish St P O Box 3579 Caesarea Ind Park 3088900 Israel Tel 972 4 6177000 Fax 972 4 6275598 www itamar medical com OT mm ss S77 ss mW ee TM ji Intertek ISO 9001 2008 and EN ISO 13485 2012 See appendix B for contact information of the regulatory authorized representative EndoPAT 2000 i Operation Manual Itamar Medical Ltd Record of Editions AA Preliminary A A 6 May04 Update following FDA clearance 1 1 Al Al 7 Dec04 Update A A X 8 May05 Update Appendix A Al 584 TI Jew I NNNM IN n general overhaul of the manual INE WENN driver Updating ISO logo list of standards Medes address Adding of AI note General update for new S W version 3 2 4 Correction in caution note regarding power supply Corrections in installation of adaptor drivers Updated patent information Correcting a omission mistakenly done in older version Update CSA symbol 10 3 10 4 56 57 Change number of tubes in the kit removal of spare tube Updating list of standards l 6 4 5 Al Feb 12 Updates for version 3 4 4 All 19 Feb 13 Updating typo standards Labeling nomm Updating minimum requirements Updating Moxa driver version Updating logo of ISO symbol Updating ED2000 label System Endo PAT 2000 Probe Package 21 Dec 2013 Updating Endo PAT report to version 3 5 x Reordering sub sections and minor rephrasing in chapte
62. les of type 532 Files 532 Cancel Figure 35 Open file dialog box Select the desired file from the list note that the file name is the same patient and visit ID used when entering the patient s information and click Open 7 2 Automatic Analysis Click the Al Icon or select Automatic Analysis from the Test Analysis menu In the EndoPAT 2000 main screen the test result s value appears in the right column as shown in Figure 36 EndoPAT 2000 Device 46 Operation Manual Itamar Medical Ltd Endo PAT2000 C Itamar Medical DataE amples Normal Endothelial Function 532 81 x File PAT Control Test Analysis Help 3 w ele ojejo mamla l g Good Endo Study Date 01 15 09 16 20 20 Results LnRHI 1 04 Al 6 ANDAA 21 00 05 00 00 10 00 00 15 00 Figure 36 Automatic analysis NOTE The AI Augmentation Index 1s one of the additional Research parameters and it is calculated and presented only if enabled as part of the license The automatic analysis identifies the occlusion 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 the automatic analysis to correctly select the regions and time references used in its calculations The user should verify that the marking of the occlusion area appears properly If the aut
63. llation wizard to find the UPort 1110 driver then click the Next button The following window is displayed EndoPAT 2000 Device 81 Operation Manual Itamar Medical Ltd Hardware Installation A The software you are installing For this hardware UPort 1110 has not passed Windows Logo testing to verify its compatibility with Windows XP Tell me why this testing is important Continuing your installation of this software may impair or destabilize the correct operation of your system either immediately or in the future Microsoft strongly recommends that you stop this installation now and contact the hardware vendor for software that has passed Windows Logo testing Continue Anyway Figure 54 MOXA Adapter Configuration XP5 2 6 Click the Continue Anyway button The following window is displayed Found New Hardware Wizard Completing the Found New Hardware Wizard The wizard has finished installing the software for zi UPort 1110 Click Finish to close the wizard Figure 55 MOXA Adapter Configuration XP6 2 7 Click the Finish button 2 8 Repeat steps 2 7 again when the Welcome to the found new hardware wizard window appears in order to install the second driver required to complete the installation 2 9 Move the adapter between all the USB sockets and let the system identify it EndoPAT 2000 Device 82 Operation Manual Itamar Medical Ltd 3 Connecting the adapter to
64. mark the artifacts as explained above Then mark the B or T segment over the marked artifacts If you do not mark the B or T segments over the artifact markings the artifacts will not be edited out and will be calculated in the T B analysis 7 9 2 Analyzing PAT Ratios After the B and T segments are marked their PAT ratios are automatically calculated displayed in the right side of the screen Figure 45 Note that these results might be slightly different from the automated analysis as this tool doesn t include all the analysis logic NOTE Automatically calculated segment ratios displayed in the right side of the screen Figure 45 do not have clinical implication This feature 1s used only for research purposes and should not be regarded as device output concerning Endothelial Dysfunction EndoPAT 2000 Device 60 Operation Manual Itamar Medical Ltd 7 10 Study printing You can print the displayed data at any time during off line review and analysis Clicking the 3 icon Print will send the current screen to the default printer 7 11 Uploading data to the server The software offers a quick link to the Itamar medical Uploading Service from the Help menu click on Link to Itamar Medical Uploading Service Follow the instruction in the browser to upload files This function requires a connection to the internet The software will open the default browser with the correct link EndoPAT 2000 Devic
65. n 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 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 Endo PAT 2000 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 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
66. n period began Thus you will not know when to release the occlusion EndoPAT 2000 Device 43 Operation Manual Itamar Medical Ltd Warning Inflating the BP cuff might cause some stress and discomfort to the patient Pay attention the patient s well being Maintain the arterial occlusion for exactly five minutes periodically check the pressure in the occluding cuff to ensure proper inflation increase pressure if required NOTE Once the occlusion has been performed the test should not be re started i e whatever problem occurs you should not stop the test and perform a new study on the same arm as vascular conditioning might have occurred It is recommended to wait at least an hour prior to performing a new study and then to study the opposite arm AT2000 AT Control zl amp x balbal 5 lala lo g ie recipes f AANA j JA Ji JI Left complete occlusion Right incomplete occlusion In both panels the bottom signal is the occluded arm Figure 34 Occlusion quality assessment 6 3 3 Post Occlusion period When exactly five minutes have passed and the stopwatch indicator starts blinking red the occlusion is complete completely deflate the pressure cuff as quickly as possible 1 Stop the stopwatch by clicking the icon 2 Click the icon to start the timer Continue to maintain the relaxed conditions throughout this period to ensure proper recording The pa
67. nal seems noisy make sure that the probes are not in touch with anything at all As the system equilibrates having a few leaks in the first few minutes is normal If you encounter more than 2 3 leaks per minute wait in Stand By mode for a few more minutes until at least a minute passed since the last leak or refer to the troubleshooting section section 9 EndoPAT 2000 Device 40 Operation Manual i m m mo I ie Stan nay mo ode Ww Ni i uuu EL E AAT Itamar Medical Ltd NOTE While working in the Stand By mode data is not recorded and therefore it is impossible to review or save the study The notification Stand By mode Figure 32 is displayed and will disappear when the button is clicked 2 Click the icon to begin study recording Verify that the recording icon appears on the right hand side of the display see the circled icon in Figure 33 NOTE Cold fingers amp small fingers will have small PAT signals with higher noise levels le x File PAT Control Test Analysis Help E elelo olo mzio Ej oo s0 00 509 H 14 M vn Endo PAT 2000 version XXX Vli UL 0 00 00 00 15 Figure 33 Recording EndoPAT 2000 Device 42 Operation Manual Itamar Medical Ltd NOTE After starting the recording the time scale will be set automatically so the full window will contain 1 minute 15 seconds periods will be marked by dotted li
68. nd the backward reflected peak P5 and then using the formula P2 P1 P1 See Figure 41 As augmentation index is heart rate related the result 1s then corrected to a standard of AI at heart rate of 75 BPM Al z7s EndoPAT 2000 Device 53 Operation Manual Itamar Medical Ltd Figure 41 AI calculation Lower AI values including negative results reflect better arterial elasticity AI is usually increasing with age and is higher in female The AI section in the report includes the AI result relative to large gender matched non selective population Average 5 95 Percentiles Al 75bpm 95 Age Years Figure 42 AI result from the report female example 7 6 2 Heart rate variability HRV Heart rate variability HRV 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 parasympathetic activities Low HRV has been described as related to various pathological conditions The Endo PAT 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 It requires 5 5 complete minutes of base line and includes all the time and frequency domain that can be calculated from this short 5minutes time period Results are EndoPAT 2000 Device 54 Operation M
69. nes If the beginning of the recording is marked by patient motion artifacts or an unstable signal consider troubleshooting procedures or extend the total period of baseline recording to give an overall period of at least 5 minutes of stable baseline data prior to the occlusion 6 3 2 Performing arterial occlusion After a stable period of baseline signal recording prepare for the occlusion 1 Change the time scale to 15 seconds 00 00 15 2 Amplify the signal gain of the occluded arm either probe 1 OR probe 2 to 20 000 3 If a stop watch will be used during the occlusion set it for down counting from 5 minutes 4 Explain the procedure to the patient stressing the importance of remaining still during the test despite the transient strange sensations i e numbness they might feel in their arm 5 Rapidly inflate the blood pressure cuff to a supra systolic level the recommended pressure is at least 60mmHg above systolic blood pressure and no less than 200mmHg Verify total cessation of blood flow to the hand total absence of PAT signal from the occluded hand If the appearance of any PAT signal is noted increase cuff pressure by an additional 50 mmHg and up to 300mmHg See Figure 34 6 Click the icon to start the timer when the cuff reaches the target occlusion pressure NOTE Without marking the beginning of the occlusion by starting the timer you will not have any means of knowing when the occlusio
70. newer features Registration enables Itamar Medical to notify you when new version of your product is available and helps Itamar Medical to provide you with customer support Registration information Submitter salutation Submitter First Name FO Submitter Last Name Submitter E mail Company Institute FO Device S N Request for additional research features activation subject to Itamar Medical approval Include Al Include FRHI Include HRV have read and accept the license terms Flead License Tonne Cancel Figure 10 Registration Dialog 3 6 3 Enter the mandatory information submitter name e mail company or institute name and device SN Device SN can be found at the bottom of the device NOTE The E mail entered in this dialog will be used for sending back the license file Please make sure this 1s a correct e mail address EndoPAT 2000 Device 17 Operation Manual Itamar Medical Ltd 3 64 If you wish to enable any of the additional research features check the feature you want to activate The use of these features is limited and they will be opened subject to Itamar Medical s approval NOTE Al FRHI and HRV have not been submitted to the US Food and Drug Administration FDA for clearance and can therefore be used in the US solely for research purposes and not for clinical use in a patient management setting 3 6 5 Read and agree to the license terms 3 6 6 Click re
71. ng trend channels NOTE Adjusting gain or time base settings affects only the display and not the recorded signal even during the recording To adjust the Gain Setting click the or sign next to the appropriate Gain Tool channel The gain display setting is increased or decreased and the new setting takes effect accordingly To Adjust a Time Base Setting click the Timing pull down menu and select the desired time base setting The time scale adjustment is automatic When a file is open an All Study option is available allowing to automatically select the nearest time base interval that exhibits the entire study s data on screen 4 3 2 Scroll Bar Use the horizontal scroll bar and left and right scroll arrows at the bottom of the Trace Window to view the entire study Scroll to the left to move backwards and scroll to the right to move forward As trace data appears in the Display Window the data is saved in the Patient Information file The study can be analyzed and reviewed off line in either relative or absolute time modes 4 4 Configuring the System The Setup menu is used to configure the system To ensure that the Endo PAT 2000 system is ready for operation the configuration of the signal channels and serial port 1s required To Configure the System 1 Verify that the Endo PAT 2000 device is properly connected to the PC and that it is switched on EndoPAT 2000 Device 24 Operation Manual Itama
72. o 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 ACBF lt 50 OR ACAD lt 20 Patients were then evaluated using the Endo PAT 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 4 5 5 5 minutes of blood flow occlusion to one arm using an upper 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 e Patient Age gt 17 Patient referred to diagnostic angiography Normal or near normal angiogram lt 30 stenosis Evaluation in catheterization laboratory Signed informed consent
73. og box metric VersiON v ww w w 33 Figure 27 File ID exists warning message aa 33 Figure 28 Patient Information Risk Factors esee 35 Figure 29 Used probes Wanin edi uode rre tue Eoo iubente cedat eee 38 Figure 30 Applying the PAT probes eeeeeeeeeeeeeeeeeeeeeeeeeeee eene enne 39 Piste 51 Hands Set Up sedis eene a Pe Rabat den ME oa bam aie uda Ete eases 40 PIguie 52 9 and By 3nOUE cereis e ERO ePi SRI oria E ti ERE dieta MEI FEPUs E DEO 4 Lioute 25 S SC OU Ia 42 Figure 34 Occlusion quality assessment ccccccccessseessseeceeeceeeaeeseeeceeeeeeaaeeeseeeeeess 44 Licure 59 Oper Ble dialog WOK sire obese e tute aba dein AA AA WA KA TI AWA 46 Figure 56 Antomatic 3Daly SIS eese de duet hunt bone i edes utinam ie dwdtae 47 Fisure 27 Occlusion Popup MU 2 Bde veoh din oeste ted ak 48 Figure 38 non selective population histograms of RHI vvemmwwnnewa 50 Figure 39 non selective population histograms of LnRHI esses 51 Figure 40 LnRHI distribution in non selective population 51 Proure 41 Al Calcul anon eer bess Mieatassene canes Des ba de pui 54 Figure 42 AI result from the report female example vvemmwwwwwa 54 Figure 43 Time domam HRV An the report uu onere a ete SUP ISR Messe Qa Poets Do Figure 44 Frequ
74. omatically marked occlusion area appears wrong it can be manually corrected as described in section 7 2 1 NOTE After launching the Endo PAT 2000 software you should wait 10 seconds before running the first test analysis This is necessary to allow termination of background processes The Endo PAT 2000 study results LnRHI or RHI and Heart Rate are presented on the right side of the screen Figure 36 EndoPAT 2000 Device 47 Operation Manual Itamar Medical Ltd The RHI Reactive Hyperemia Index or LnRHI natural log of RHI is the post to pre occlusion PAT signal ratio in the occluded arm relative to the same ratio in the control arm corrected for baseline vascular tone of the occluded arm where Normal EndoScore RHI gt 1 67 or LnRHI gt 0 51 Abnormal EndoScore RHI lt 1 67 or LnRHI x 0 51 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 4 icon to clear all markings from previous analyses Select the occlusion borders using one of the following 3 alternative methods 1 Position the mouse s cursor on the occluded PAT tracing so that it points at the beginning of the occlusion Click and hold down the left mouse button and drag the cursor rightwards until it points at the end of the occlusion area The selected area will have inverted colors and as you mark it the length of the selected period w
75. or this purpose and signed by Itamar and you Note Should you have any questions concerning this License Agreement or if you desire to contact Itamar for any reason please write to Itamar Medical Ltd 9 Halamish St Caesarea Ind Park 3088900 Israel Facsimile 972 4 627 5598 or visit Itamar s web site at www itamar medical com EndoPAT 2000 Device 76 Operation Manual Itamar Medical Ltd Appendix B Regulatory Authorized Representative MEDES Ltd EC REP 5 Beaumont Gate Shenley Hill Radlett Hertfordshire WD7 7AR England Tel 44 20 8123 8056 Tel Fax 44 1923859810 Endo PAT 2000 Device 77 Operation Manual Itamar Medical Ltd Appendix C installing the USB adaptor for Windows XP This appendix describes how to install the MOXA adapter and driver for Windows XP Home and for Windows XP Pro editions NOTE The MOXA adapter must not be connected to the computer or to the Endo PAT 2000 device while the driver is installed 1 Install the driver 1 1 Do not connect the USB adaptor to the computer yet 1 2 Insert the Moxa adapter drivers CD into the CD ROM drive 1 3 Browse into CD ROM Drive XP 1 4 Double click the mxusb_setup_1 3 exe file 1 5 Complete the installation process by clicking next on all screens until the following screen is displayed ie Setup MOXA UPort 1110 1130 Windows Driver f ox Ready to Install Setup is now ready to begin installing MOA UPort 1110 113
76. r contained in the Licensed Software or a Licensed Product 4 LIMITED WARRANTIES AND DISCLAIMERS a Against Infringement Itamar hereby warrants to you that it has the right to grant you the license to use the Licensed Software and or the Licensed Product and to enter into this License Agreement and that neither the Licensed Software nor the Licensed Product s infringes the intellectual property rights of any third party EndoPAT 2000 Device 73 Operation Manual Itamar Medical Ltd b As to Licensed Product Itamar warrants that the Licensed Product with which this License Agreement was delivered will be free from defects in design materials and workmanship for a period of one year from the date of delivery of the Licensed Product to you If the Licensed Product contains a defect in design materials or workmanship and such Licensed Product is returned to Itamar within one 1 year of delivery of the Licensed Product to you Itamar will repair or replace the Licensed Product or issue a credit for the purchase price of the Licensed Product with the choice to repair replace or credit being within the sole discretion of Itamar The foregoing repair replacement or credit remedy will be your sole remedy for breach of the warranty set forth in this Section 4 b c As to Licensed Software Itamar warrants that for a period of ninety 90 days from the date of delivery of the Licensed Software to you the Licensed Software will under normal
77. r 7 analysis to improve readability OS support update remove Vista add Win8 Jan 2014 Updating zip code Updating standard table Update Troubleshooting table Updating Endo PAT 2000 A System B Mana Remvinganeronensestison neela euni Corer paee CENE ER 14 Adding trade mark symbols and relevant updated MEDES address updating n B 10 4 ia 78 Itamar Medical address updating zip code and Ind Park i 70 2014 Insert note Updating Endo PAT 2000 label System 10 4 68 gt uly 2014 Remove wrong quotation marks Add EndoScore 12144 ESI Correct Power supplier current Update temperature ranges related symbols probe package 69 Note Latest version of the EndoPAT User Manual is available at http www itamar medical com Support Downloads html EndoPAT 2000 ii Operation Manual Itamar Medical Ltd Table of Contents 1 General Information cccccsessscssscscececncnceceeecnnennnenenenenenenenenes 1 1 1 Intended Use of the Endo PAT 2000 Device eene eene 1 1 2 Performance and clinical study information 1 1 3 Equipment Classification Le re rr rr rr rere rere 3 1 4 Manufacturers NOUGCG 5ecieaux va ee veutux cc eiue rein wa etwa ux vauE ve Ex va c va qe Ya ud wi Coa auda CE auus 3 1 5 Restrictions for Nc 3 1 6 Quality Assurance System ISO 9001 amp ISO 13485
78. r Medical Ltd 2 Click PAT Control and then select Setup PAT Control Test Analysis Inflate Peate Stop Standby a Start timer Hesel Timer Probes Information Registration Figure 16 The setup command 3 The following screen will appear Setup xi Serial Port PAT COM EXTERNE Check com Automatic Search COM 1 C0M10 Site name amr 00 Endothelial Function Index Pressure Contral Fived Pressure mmHg 70 Diastolic blood pressure dependent LnRHI BHI Cardiovascular Risk Factors Default Cardiovascular Risk Factors Method None Cholesterol Level Units mg do m lf Registration Reminder Message Countdown Clock B x Start Time min Manual Research Mode Figure 17 The setup dialog box Cancel Report Setup Set PATo EndoPAT 2000 Device 25 Operation Manual Itamar Medical Ltd 10 11 12 Click Automatic Search COM1 COM10 to allow the system to automatically identify the COM port to which the Endo PAT 2000 device is connected If the automatic search fails you can select or type the correct COM port for the Endo PAT 2000 device manually in the relevant field After selecting the desired COM port verify communication by clicking Check COM Fill the Site Name This will turn off the dialog box asking to do it on system startup Select the Endothelial Function index that will be used
79. r illustrative purposes only 1 8 Safety Precautions WARNING Only the power supply that is provided within the Endo PAT 2000 package will be used for the system Use of an inappropriate adapter may cause irreparable damage to the device and may compromise patient safety WARNING The Endo PAT 2000 device should only be installed with and connected to computer equipment that complies with EN60950 safety regulations Failure to heed these warnings may compromise patient safety 1 The Endo PAT 2000 device has been designed and manufactured to meet all safety requirements applicable to medical equipment To ensure maximum operation safety the system should be used and maintained in strict compliance with the safety precautions warnings and operating instructions provided in this manual 2 The system contains no user serviceable parts It should be maintained and serviced only by qualified service personnel authorized by Itamar Medical Ltd 3 Purchasers of the Endo PAT 2000 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 1s recommended that a list of authorized operators be maintained 4 The EndoPAT 2000 device Operation Manual should be carefully studied by the EndoPAT 2000 Device 6 Operation Manual Itamar Medical Ltd authorized operators and stored where it is easily accessible P
80. rmation Dialog and not the Risk Factors Dialog Patient Information Risk Factors x Cancel Cardiovascular Risk Factors Method Total Cholesterol Level mg dL HDL Cholesterol Level mg dL hsCRP Result mg L Diabetic Yes C No Smoker Yes C No Treatment for HTN C Yes C No CVD History C Yes C No Family CVD History C Yes C No European Risk Region High Low Figure 28 Patient Information Risk Factors EndoPAT 2000 Device 35 Operation Manual Itamar Medical Ltd 6 Conducting an EndoPAT 2000 Study 6 1 Pre Study 6 1 1 General description The Endo PAT system is comprised of a system console and two independent sensing probes coupled to connecting pneumo electric tubing and foam finger mounting rings The system console is connected to a computer loaded with a specific program for controlling the Endo PAT system The system console has two separate external switches for inflating and deflating the probes The probes can be inflated and deflated via the computer program as well The probes pressure and the setting of displayed signals are configured through the setup function in the PAT Control pull down menu see Figure 16 Signal gain and time base are set through icons appearing on the Tool Bar see section 4 3 1 If the probes pressure mode was initially configured to a fixed pressure then the recommended pressure setting is 50mmHg The eligibility of a patient for an
81. rmation from the hsCRP blood test a measure of inflammation and whether or not either parents had a heart attack before age 60 genetic predisposition on top of the traditional risk factor analysis Reynolds Risk Score applies only to healthy population without diabetics above the age of 45 Female Male with diabetics should not be evaluated using Reynolds Risk Score as they are already considered to be a high risk group for both heart disease and stroke For more information visit http www reynoldsriskscore org faq aspx 7 6 Additional Research Features NOTE Please note that the Endo PAT analysis of Augmentation Index AD Heart Rate Variability HRV and FRHI are not FDA cleared and can be applied for clinical use out of the US only NOTE To activate any Additional Research Feature you should submit a request to Itamar as part of the Registration process See section 3 6 above 7 6 1 Augmentation Index AI Augmentation index is a measure of arterial stiffness calculated based on pulse wave analysis of the signal measured by the Endo PAT 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 endothelial function AI in the Endo PAT 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 a
82. rograms option Select the Endo PAT 2000 software and press Remove 3 8 Shutting Down the System a Shut down the EndoPAT 2000 software program by selecting Exit in the pull down File menu b Switch OFF the EndoPAT 2000 device using the on off switch on the back panel EndoPAT 2000 Device 19 Operation Manual Itamar Medical Ltd 4 Software Description 4 1 Main Screen PAT From the Windows desktop double click the av icon The following screen will appear see Figure 12 Endo PAT2000 File PAT Control Test Analysis Help Itamar Medical Ltd Endo PAT 2000 version X X X Figure 12 Main screen The Main Menu Screen is the gateway to the functions of the Endo PAT 2000 software The three primary functions are perform a study review and analyze a study and system configuration The main screen includes 1 Interfaces e Pull down menu bar section 4 2 e Tool bar section 4 3 e Scroll bar section 4 3 2 2 Display windows EndoPAT 2000 Device 20 Operation Manual Itamar Medical Ltd e Channels identification column for the PAT waveforms e PAT waveforms window e Results calculations column 3 Status bar e PAT state communication status between PAT device and computer e Program status e Probe status When first launching the Endo PAT 2000 software a dialog box Figure 13 will open Click the OK button and enter the Setup menu Complete the setup as described in s
83. rvice Table 1 Main screen pull down menu commands 4 3 Main Screen Tool Bar The Main Screen tool bar buttons provide quick access to selected menu commands opens result table and to the Gain and Timing settings Gain and Timing settings are used to adjust the Trace Window display Dimmed icons indicate that they are not active and cannot be used unless some actions are taken For example the automatic analysis icon is not active unless there is a data file displayed and ready to be processed Endo PAT 2000 Device 27 Operation Manual Itamar Medical Ltd Table 2 lists each button and its function Mouse over a button to trigger bubble help describing the button s function Mark segment as B in Manual Research mode only Mark segment as T in Manual Research mode only Mark segment as artifact in Manual Research mode only or eM Sete base and gains 000000 Table 2 Tool bar buttons and functions Ill 5 I e lil EndoPAT 2000 Device 23 Operation Manual Itamar Medical Ltd 4 3 1 Gain and Time base trace display Tools Use the Gain command to adjust the Trace Window display Figure 15 Gain and time base scroll boxes The two gain tools adjust the traces display of the PAT 1 and PAT 2 channels The scroll boxes are in order from left to right left is probel and right is probe2 Adjustments made to the PAT channel gain settings affect only the display of the correspondi
84. s Time markers can be inserted manually into the data while recording This is used only for manual data analysis as described in section 7 9 To insert a time marker press any of the 10 number keys on the keyboard The time marker cannot be erased after it is set However it does not interfere with the data You can set as many markers as you like EndoPAT 2000 Device 45 Operation Manual Itamar Medical Ltd 7 Review and Analysis During a PAT study recorded signals are viewed in the display window and 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 It is recommended to review each study upon completion of its recording 7 4 Study Data Retrieval From the toolbar click the 5 icon or select Open File from the menu bar The following dialog box appears Open 32 file Look in tutorial amp j Mame Siege Type Date Modified E Arrhythmia and incomplete ac 6654 KB 532 File 2103 2006 10 18 Ej Baseline too short s32 3 4568 KB S32 File 30 03 2003 18 44 Ej Endothelial Dysfunction S32 7667 KB 532 File 16 02 2006 09 01 Ej Incomplete Occlusion 532 S877 KB 532 File 2111212004 19 44 Ies Normal Endothelial Function 532 8 006 KB 532 File 17 01 2006 09 20 Ej User dependent noises 532 127 042 KB 532 File 26 08 2004 22 51 File name Fi
85. sed with medical device ISO 15223 1 labels labelling and information to be supplied General requirements Graphical symbols for electrical equipment in medical IEC TR 60878 practice Graphical symbols Safety colours and safety signs ISO 7010 M002 Registered safety signs refer to instruction manual booklet Information supplied by the manufacture with medical devices EN 1041 Medical Device Directive MDD 93 42 EEC MDD 2007 47 EC Medical devices Application of usability engineering to BS EN 62366 medical devices 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 1n 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 EndoPAT 2000 Device 5 Operation Manual Itamar Medical Ltd 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 Endo PAT 2000 device Operation Manual carefully before operating the system All pictures are fo
86. serting the fingers into the probes ensure all heavy clothes tight fitting sleeves rings watches and jewelry were removed from patient s hands and arms EndoPAT 2000 Device 37 Operation Manual Itamar Medical Ltd 6 2 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 The patient should be kept comfortable and fully relaxed and asked to refrain from talking Staff should avoid talking to the patient and between themselves as much as possible These conditions should be kept throughout the entire study To avoid communication problem make sure there are no other applications running on the system s computer any wireless communication in the computer is turned off and the device is connected directly to the computer 6 2 2 Initializing the EndoPAT system Activate the Endo PAT 2000 application Enter patient details as required Please note that the ID should be specifically assigned to the subject and 1s going to be allocated as the file name for the recorded Endo PAT study Ensure that the pneumo electric tubings are properly connected to the Endo PAT 2000 device and a new set of probes is installed and ready for use If the probes are not new when you try to inflate the probes a warning dialog box Fig
87. the Endo PAT 2000 device 3 1 Connect the MOXA Adapter to the COM TO COM cable and tightly screw the bolts z n MER MC c lt Figure 56 connect MOXA adaptor 3 2 Connect the COM TO COM cable to the EndoPAT 2000 device and tightly screw the bolts Figure 57 connect COM TO COM 3 3 Open the Endo PAT 2000 software and verify that the PAT indicator on the bottom right 1s colored green EndoPAT 2000 Device 83 Operation Manual Itamar Medical Ltd Appendix D installing the USB adapter for Windows 7 or 8 This appendix describes how to install the MOXA adapter and driver for Win7 and Win8 NOTE The MOXA adapter must not be connected to the computer or to the Endo PAT 2000 device while the driver is installed 1 Installing the MOXA driver 1 1 Insert the CDROM media into your CDROM drive 1 2 Start the installation by double clicking on the Win 7 Sidriv win uportlp v1 6 build 09062913 whgi file NOTE If the following window Figure 58 or Figure 59 is opened please press the Allow option User Account Control Don t run the program unless you know where it s from or you ve used it before gt dry win uportlp v1 4 build 07100420 whal exe Unidentified Publisher gt Cancel I don t know where this program is from or what it s for User Account Control helps stop unauthorized changes to your computer Figure 58 Win Security EndoPAT 2000 Device
88. 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 972 4 617 7000 ext 399 or from the US 800 206 6952 ext 399 1 6 Quality Assurance System ISO 9001 amp ISO 13485 E STANDARD l Medical electrical equipment Part 1 General requirements IEC 60601 1 for basic safety and essential performance Medical electrical equipment Part 1 2 General requirements IEC 60601 1 2 for basic safety and essential performance Collateral standard Electromagnetic compatibility Requirements and Medical electrical equipment Part 1 4 General requirements IEC 60601 1 4 for safety Collateral Standard Programmable electrical medical systems Medical Device Software Software Life Cycle Processes IEC 62304 Quality management systems requirements ISO 9001 2008 Medical devices Quality management systems Requirements EN ISO 13485 2012 for regulatory purposes Medical devices Quality management systems CAN CSA ISO Requirements for regulatory purposes Health Canada 13485 2003 Medical devices Application of risk management to medical ISO 14971 devices EndoPAT 2000 Device 4 Operation Manual Itamar Medical Ltd Medical devices Symbols to be u
89. the screen blinks red e To stop the timer click the cc icon again The timer stops counting e To restart the timer click the icon The timer resets and starts counting according to the set up in the setup screen 4 6 Setting the Default Printer Setting the default printer is performed in the normal manner by accessing the Printer Setup window from the Windows desktop EndoPAT 2000 Device 29 Operation Manual Itamar Medical Ltd 5 Preparing for a Study 5 1 Preparing the System for a Study Accessories that are required beside the Endo PAT 2000 system e A set of two PAT probes and anchors e Blood pressure cuff capable of sustaining high pressures for 5 minutes e Adhesive tape e Pair of arm supports e Timer stopwatch optional Switch on the computer the Endo PAT 2000 device and launch the Endo PAT 2000 software with the shortcut icon on the desktop When the Endo PAT 2000 software is launched it performs an automatic COM port search and communication test with the device If the software 1s unable to establish communication with the device a COM port search dialog box will open Figure 21 While this dialog box is open the system continues trying to establish communication with the device going through COM ports to 10 in a cyclical manner This continues until communication is established or Work Disconnected is selected x Searching for communication COM1 COM10 COMS3 If device is conn
90. the vascular conditions of the patient Therefore if blood pressure measurement needs to be taken prior to the Endo PAT study the following should be considered e The blood pressure should be measured from the patient s control arm the arm that is not occluded during the Endo PAT study e Jt is recommended to allow 5 minutes to pass between the time of the blood pressure measurement and the commencement of the Endo PAT baseline recording 6 1 5 Positioning the patient The patient should sit 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 deformities or injuries that could affect the study The probe should not be used on a finger that 1s cut injured or unusually sensitive Fingernails should be trimmed and filed if necessary to avoid damaging the internal membranes of the PAT probes amp displacing the finger from the sensing region of the probe resulting in a smaller PAT signal and inaccurate results The index finger is the recommended finger for the study however if this finger 1s too large to comfortably fit into the probe or is otherwise unsuitable see above a different finger except the thumb may be used as long as it 1s the same finger in both hands WARNING Long nails may cause distorted PAT signals and may cause the study to fail Before in
91. tient will experience strange sensations after the cuff deflation amp might feel an urge to move the test arm This should be discouraged EndoPAT 2000 Device 44 Operation Manual Itamar Medical Ltd 3 When the stopwatch indicator starts blinking red the post occlusion is complete stop the stopwatch by clicking the co icon 6 3 4 After the Study is Completed Click the o icon to end the recording This will also deflate automatically the probes allowing their removal from the patient s fingers Carefully remove the tape PAT probes anchors and the occluding upper arm cuff from the patient Disconnect the PAT probes and discard them As it 1s impossible to visually differentiate used from unused probes we recommend placing a piece of tape the one taken off the adjacent finger around each used probe prior to discarding the probes Once you click the 9 icon to end the recording the patient file will be automatically saved to the hard disk with the previously entered patient ID as the file name By default the data folder is located in the data folder in the Itamar Medical folder in C drive NOTE If the probe doesn t deflate after ending the study with the O icon manually deflate via the deflate button on the device It can also be accessed directly from the desktop by using the BHIE icon After finishing recording a study open the recorded file for review see next chapter 6 3 5 Setting time marker
92. to the tip of a Doppler wire using a computer based image EndoPAT 2000 Device l Operation Manual Itamar Medical Ltd analysis system Average peak velocity APV is derived from the Doppler flow velocity spectra and coronary blood flow CBF is determined as m coronary artery diameter 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 1s defined as an increase in CBF of gt 50 and an increase or less than 20 decrease in the coronary artery diameter in response to the maximum dose of intra coronary Ach ACBF gt 50 and ACAD gt 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 Endo PAT 2000 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 t
93. ty Poor Signal Quality Program Failure Incomplete occlusion Endo PAT 2000 Device Occlusion is 90 sec or less might be rectified after manual occlusion marking More than 10 min occlusion might be rectified after manual occlusion marking Post occlusion less than 2 min and 30 sec Might be rectified after manual occlusion marking The system cannot identify the occluded section of the study might be rectified after manual occlusion marking Poor occlusion quality due to too many valid pulses identified during the occlusion Poor signal quality in the post occlusion period used by the analysis 1 5 2 5 min post occlusion Any other problem that prevents the program to complete the analysis call Itamar Medical customer support There are measured pulses during the occlusion in the occluded hand Occlusion quality is too low for a good hyperemic response Table 6 Error messages 65 Operation Manual Itamar Medical Ltd 10 Technical Information 10 1 System Minimum Requirements An IBM or compatible PC Pentium Celeron AMD 1000 MHz CPU or higher Windows XP Windows 7 Windows 8 x86 x64 operating system Any Internet browser or Excel 2000 and above 1 GB RAM for XP or 2 GB for Win7 Wing 1 GB free hard disk space XGA display 1024 x 768 pixels or better One available serial port or one available USB port with USB to Serial adapter installed Optional Hardware Large removable med
94. ure 29 will open Itamar Medical EE xi x Used probes Replace with new ones Figure 29 Used probes warning WARNING The probes are single use and disposable they will not work if they have already been used 6 2 3 Patient preparation First ensure that a blood pressure cuff 1s placed on the upper arm of the designated test arm Then the PAT probes should be placed inside the appropriate sockets of the arm EndoPAT 2000 Device 38 Operation Manual Itamar Medical Ltd supports see Figure 30 1 Fully deflate the probes by clicking the amp icon in the software or by pressing the Deflate button on the device Place the study fingers into the probes making sure the fingers are inserted all the way to the end of the probe see Figure 30 2 Inflate probes by pressing the Inflate button on the device or clicking the S icon NOTE The index fingers are preferred however any finger other than the thumb may be used provided that the same finger is used in both hands Place the blue foam anchor ring on the adjacent finger to the one with the probe on as near as possible to the finger s root The anchors should be placed as far back as possible on the finger so that they do not come in contact with the PAT probe such contact may result in mechanical artifacts during recording see troubleshooting guide in section 9 Table 5 2 Figure 30 Applying the PAT probes Make sure the tubing
95. who have a known natural rubber protein allergy Failure to heed this warning will compromise patient safety The latex probes have a yellow membrane and come in boxes with labels notifying that they contain latex The new non latex probes have green internal membranes EndoPAT 2000 Device 7 Operation Manual Itamar Medical Ltd 2 System Overview The Endo PAT 2000 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 Endo PAT 2000 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
96. will be reduced to fit the page Each of the 3 lines can contain up to 70 characters EndoPAT 2000 Device 26 Operation Manual Itamar Medical Ltd Report Appearance X Logo Set Logo Current Logo Clear Logo Figure 18 Report Appearance dialog box Clinique details Clinique details Clinique details Clinique details Clinique details Clinique details Clinique details Clinique details Clinique details Endo PAT2000 Test Date 17 01 2006 08 59 48 Figure 19 The example for report header 13 The name of the operator performing the Endo PAT 2000 study can be saved with the study data The system offers the user to choose from a predefined list or enter names manually if the manually entered name doesn t exist in the list it will be automatically added to the list of offered names To create or change the master list from which the names are selected click the Set PATographer to open the following dialog box EndoPAT 2000 Device ZI Operation Manual Itamar Medical Ltd PA lographer Information PAT ographer Name List of PAT ographers Remove OK Cancel Figure 20 The PATographer Information dialog box Type the names of the PATographers in the top field and click Add after each one is entered Once you finished entering all the names click OK to save the information and exit Click the Cancel button to exit without saving the changed informat
97. www framinghamheartstudy org risk hrdcoronary html 7 5 2 SCORE SCORE is the European risk prediction system providing a 10 year risk of fatal CVD SCORE is representative of typical European populations and the risk score system has been optimized for coronary prevention in European clinical practice Risk may be higher than indicated in Sedentary or obese subjects especially those with central obesity Those with 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 without diabetes Those with low HDL cholesterol or high triglycerides e Asymptomatic subject with evidence of preclinical arthrosclerosis for example reduced ankle brachial index The Endo PAT device is using the General version of the SCORE using the low and high risk countries and not national versions For this use European Low Risk Belgium France Greece Italy Luxembourg Spain Switzerland and Portugal European High Risk All other European Countries For more information search SCORE in www escardio org EndoPAT 2000 Device 52 Operation Manual Itamar Medical Ltd 7 5 3 Reynolds Risk Score Reynolds Risk Score is designed to predict the risk of having a future heart attack stroke or other major heart disease in the next 10 years The Reynolds Risk Score is a newly developed score that includes info

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