Home

Endo_PAT user manual for 3 2 4

1. ssssssausunausanzunzunanznuzunanzauzananuna 55 10 1 System Requirements aaa 55 102 Operating UA 55 10 3 Technical information about labeling s s ssssmsusnananusuanananzananzuza 55 10 4 DAD GNM G aa 57 10 5 10 5 Specifications for Endo PA T2000 ccccesceseeeeeesnseneensensensenees 58 10 5 10 5 Specifications for Endo PA T2000 ccsceseeseeeeeesensensensensensenees 59 Appendix A License Agreement and Limited Warranty s s 60 Appendix B Regulatory Authorized RepresentativVe sss s 67 Appendix C installing the USB adaptor for Windows XP 68 Appendix D installing the USB adapter for Windows Vista 14 Endo PAT2000 V Operation Manual Itamar Medical Ltd List of Figures ELA KISA cam KAA SE 6 penne tee re AAA WALAMANI WA IA MA MAA MA AI 9 Proure 2e Endo PAT2000 ii 10 Figure 3 Connection of pneumo electric tubing and USB adaptor vvv 11 Picure 4 Ts AA WAZ At ia 12 Kiure Tcen e agreement AA 13 Figure 6 Installation folder Aa 13 Figure 7 Ready to install the program screen cccccseeeeeeececeeceeeeeeeaeeeeeeeseeeeeees 14 Ficure 6 Completion Ol 1WStallatiOn ai kata ahaa ii khaki KARIA 14 Pome 9 VAIN SCL N ea EE EEE T E ETET 17 Figure Oi Pill Site name dialo AA 18 Figure 11 Gain and time base scroll DOXES ii 21 Prsure gt Tine SEID AA AA AA oboe Senyeueare 22 Figure 132 The setup dialog BA
2. 2 Stop the stopwatch by clicking the icon 3 Click the icon to start the timer Continue to maintain the relaxed conditions throughout this period to ensure proper recording The patient will experience strange sensations after the cuff deflation amp might feel an urge to move the test arm This should be discouraged 4 When the stopwatch indicator starts blinking red the post occlusion is complete stop the stopwatch by clicking the Icon Endo PAT2000 40 Operation Manual Itamar Medical Ltd 6 3 4 After the Study is Completed Click the u 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 is 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 u 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 a It can also be accessed directly from the desktop by using the BMHEES icon After finishing recording a study open the recorded file for r
3. i Cancel Figure 7 Ready to install the program screen 7 Press Finish when the installation is complete Figure 8 ie Endo PAT2000 Setup InstallShield Wizard Completed The InstallShield Wizard has successfully installed Endo PAT2000 Click Finish to exit the wizard Figure 8 Completion of installation 8 An icon will be added to the desktop 9 If used install the USB to COM driver as described in section 3 5 Endo PAT2000 14 Operation Manual Itamar Medical Ltd 3 5 Installing the RS 232 to USB adaptor The RS 232 to USB adaptor connects the Endo PAT2000 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 and for Windows Vista 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 or to Appendix D for instructions on how to install the driver on Windows Vista Enterprise 3 5 1 General instruction for installing the driver 1 The driver installation must be done before connecting the RS 232 to USB adaptor to the computer 2 Insert the CD into the CD ROM drive 3 Browse into the CD ROM drive D Your_OS SETUP 4 Execute the Driver s exe file Continue the installation process by clicking next until installation ends 6 Connect the RS 232 to USB adapter to the computer Note Restart you
4. 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 Endo PAT2000 65 Operation Manual Itamar Medical Ltd 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 inten
5. Click Install to continue with the installation or click Back if you want bo review or change any settings Destination location oe C Program Files Moxa SB Driver Cancel Figure 34 MOXA USB Installation XP1 Endo PAT2000 68 Operation Manual Itamar Medical Ltd 1 6 Click Install 1 7 The following screen is displayed Software Installation A The software you are installing has not passed Windows Logo testing to very its compatibility with Windows SP Tell me why this testing iz 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 Figure 35 MOXA USB Installation XP2 1 8 Click Continue Anyway you need to approve this warning twice The following screen is displayed is Setup MOXA UPort 1110 1130 Windows Driver Completing the MOXA UPort 1110 1130 Windows Driver Setup Wizard Setup has finished installing MOA UPort 1110 1130 Windows Driver on your computer Click Finish to exit Setup Finish Figure 36 MOXA USB Installation XP3 1 9 Click Finish Endo PAT2000 69 Operation Manual Itamar Medical Ltd 2 Configuring the MOZA Adapter 2 1 Plug in the adapter t
6. LICENSED PRODUCT OR 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 Ther
7. 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 Set up menu is used to configure the system To ensure that the Endo PAT2000 is ready for operation the configuration of the signal channels and serial port is required Endo PAT2000 21 Operation Manual Itamar Medical Ltd To Configure the System 1 Verify that the Endo PAT2000 is properly connected to the PC and that it is switched on 2 Click PAT Cont
8. 19 44 17 01 2006 09 20 26 08 2004 22 51 File name Files of type 532 Files 532 Cancel Figure 30 Open file dialog box Select the desired file from the list note that the file name is the same ID number used when entering the patient s information and click Open Endo PAT2000 42 Operation Manual Itamar Medical Ltd 7 2 Automatic Analysis Click the Al Icon or select Automatic Analysis from the Test Analysis menu In the Endo PAT2000 main screen the test result s value appears in the right column as shown in Figure 31 gt Endo PAT2000 C EndoPAT2000 Data Examples Normal Endothelial Function S32 ER 18l x Itamar Medical Ltd Endo PAT 2000 yersion 3 2 4 GoodEndo Study Date 01 15 09 16 20 20 Results RHI 2 84 Al 6 AI 75 21 HR 98 bom Probe Occlusion duration 00 05 00 00 05 00 00 10 00 00 15 00 a pi p2 BF An PROGRAM STATE READY MBM i Figure 31 Automatic analysis NOTE The AI Augmentation Index is calculated automatically from the PAT signal in non US and in research versions only The automatic analysis identifies the occlusion and marks it in blue Proper identification of the occlusion area is critical for the automatic analysis to correctly select the regions used in its calculations The user should verify that the marking of the occlusion area appears reasonable If the automatically marked occlusio
9. 4 5 Using the Timer Countdown Cl0ck 1 essessesseeseeseensenensensenssnseneees 26 4 6 Setting the Default Printer c cccsceesccsseeseesseeseeesnsenseensenseeesenseeeenaes 26 5 Preparing for a Study s s s 27 5 1 Preparing the System for a Studly ccccccecceeseeseeseeseeeeeeeeeeeeenseneeneeneeneens 27 5 2 Connecting the PAT Probe 27 5 3 Creatine a Patent IA 28 6 Conducting an Endo PAT2000 Study s smmmsususuanananana 31 6 1 PreS Ud Ya aaao 31 6 2 Patient and System SOU Peiscseced ie cdcced de cetises cewsivewk cecttvensenwasecdaneaimeaeecdoasdewek 33 6 3 Performing the Study cases cs secs cccs cei cs co secs once cess ncctecasea ce eccseecschesesceeceseacseeve 36 7 Review and Analysis s s 42 7 1 Study Data Retrieyal waa 42 7 2 Automatic ATIALYSIS sescesnacececesetesaicsncdedesscacdaieuceadescusiavetiosbisiedesndsisdeazecssdee 43 7 3 BS AUC Wi INA AA 47 7 4 Manual Analysis Research Mode only c csssscsceseseseeseseneeseneneeseeeaeeeens 48 7 5 Study report amp PTINting s sssmasumzanuanannanasnanzananuanauananzanaananznzana 50 7 6 Uploading data to the server 1 c scecscescesseeseensenseeesensenssnsenseessensenseoaees 50 Endo PAT2000 IV Operation Manual Itamar Medical Ltd 8 MA AAA 51 9 TUI AA AAA 52 10 Technical Information
10. License 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 intended use in testing of endothelial function in 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
11. The new non latex probes have green internal membranes Endo PAT2000 7 Operation Manual Itamar Medical Ltd 2 System Overview The Endo PAT2000 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 PAT2000 is a new type of finger plethysmograph that imparts a uniform pressure field to the distal two thirds of the finger including its tip It was designed to avoid many of the existing problems associated with conventional plethysmographic devices such as distal venous distention and the resulting induction of reflex veno arteriolar constriction and it has a higher dynamic range of changes and better clamping to the finger Its extended pressure field also excludes spurious venous signals while continuously recording the digital arterial pulse wave Studies using the Endo PAT2000 are easily performed in any clinical setting with a minimal pe
12. analysis Clicking the 8 icon Print will send the current screen to the default printer To review the study report select the View report 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 This report can be printed or exported to other formats i e PDF 7 6 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 Endo PAT2000 50 Operation Manual Itamar Medical Ltd Maintenance This chapter describes preventative and regular maintenance for the Endo PAT2000 Only gualified medical personnel should use this eguipment In the event of eguipment 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 PAT2000 device should be free of dirt and debris Using a soft slightly damp cloth gently wipe
13. 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 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 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 deformations or injuries that could affect the study
14. can remove unused names by selecting a name in the bottom field and clicking Remove 12 In the Pressure control frame select whether the probe inflation pressure is set to a pressure that 1s dependent on the patient s diastolic blood pressure recommended mode or to a fixed pressure 13 If a fixed pressure setting is selected the inflation pressure can be changed from the default 5 0mmHg 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 14 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 Endo PAT2000 25 Operation Manual Itamar Medical Ltd NOTE Setup can be opened while recording a study to select which signals are displayed However during a recording the COM field and the Pressure Control fields are disabled and cannot be modified 4 4 1 Switching to the Research Mode 1 From the PAT Control menu select the Setup option The Setup window is displayed 2 Inthe Setup window select the Research mode checkbox then click OK Refer to Figure 13 4 5 Using the Timer Countdown Clock Some phases in the study recording require strict timing To
15. marking or legend placed on or 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 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 use be free from defects in materia
16. 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 coy icon When the timer reaches 0 the timer indicator at the bottom right of the screen blinks red e To stop the timer click the 9 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 Endo PAT2000 26 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 PAT2000 system A set of two PAT probes and anchors Blood pressure cuff capable of sustaining high pressures for 5 minutes Adhesive tape Pair of arm supports Timer stopwatch 1 Switch on the computer the Endo PAT2000 device and launch the Endo PAT2000 software with the shortcut icon on the desktop When the Endo PAT2000 software is launched it performs an automatic COM port search and communication test with the device If the software is unable to establish communication with the device a COM port search dialog box will open Figure 17 While this dialog box is open the system continues trying to establish co
17. or higher Windows XP Vista 32bit operating system Any Internet browser or Excel 2000 2003 512 MB RAM for XP or 1GB for Vista 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 media such as CD R or DVD R for storage of study files Printer higher resolution preferred Color recommended 10 2 Operating System English version Windows XP or Vista 32 bit 10 3 Technical information about labeling Double isolation of power supply Year of manufacture Pay attention first read the user manual Endo PAT2000 59 Operation Manual Itamar Medical Ltd Type BF applied part The Endo PAT2000 is certified by CSA The Endo PAT2000 complies with the CE EMC Directive and related standards 047 The unit is marked with the CE logo and a CE conformity card is included in every shipment K Use within 2 5 years from date of manufacture Q Single use only do not sterilize Maximum allowed temperature Name and address of the manufacturer Catalogue Number Serial Number Endo PAT2000 56 Operation Manual Itamar Medical Ltd 10 4 Labeling Label on the base of the Endo PAT2000 main control unit Endo PAT 2000 Type SN Rev ad itamar Medical Ltd REF 9 Halamish st Caesarea Industrial Park 38900 Israel Tel 972 4 6177000 Fax 972 4 6275598 E mai
18. 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 12 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 a Endo PAT study is entirely at the discretion of the patient s physician and is generally based upon the following criteria e Symptoms and complaints e Medical history e Risk factors e Current medication 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 Endo PAT2000 31 Operation Manual Itamar Medical Ltd 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
19. the Mayo Clinic Rochester MN and that had been designed to evaluate the safety and effectiveness of the Endo PAT2000 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 Endo PAT2000 l Operation Manual Itamar Medical Ltd The Gold Standard for Endothelial Dysfunction evaluation the Intra coronary Acetylcholine Ach Challenge method is routinely performed at the Mayo Clinic According to the Intra coronary Acetylcholine Ach Challenge method a catheter is positioned in the origin of the left main coronary artery and Ach is infused with incremental concentration followed by coronary angiogram The coronary artery diameter is measured in the segment 5mm distal to the tip of a Doppler wire using a computer based image analysis system Average peak velocity APV is derived from the Doppler flow velocity spectra and coronary blood flow CBF is determined as m coronary artery diameter 2 APV 2 Endo
20. the exterior of the Endo PAT2000 device avoiding contact with open vents and plugs 3 The probes should be discarded after each use and replaced with new ones Endo PAT2000 51 Operation Manual Itamar Medical Ltd 9 Troubleshooting 1 The Endo PAT2000 does not switch on the orange LED on the device is not on No communication between PC station and Endo PAT2000 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 is red instead of green Frequent pressure leaks during study Endo PAT2000 The Endo PAT2000 power is switched off Power cable is not plugged to the power outlet Power cable is not connected to the Endo PAT2000 device Endo PAT2000 power switch is off Communication cable between PC station and Endo PAT2000 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 PAT2000 device Faulty probe Faulty pneumatic cable N e Replace PAT probe e Replace pneumatic cable Switch on the Endo PAT2000 device Switch off the Endo PAT2000 device Plug the power cable to the power outlet Switch on the Endo PA
21. 10 1130 Windows Driver Setup Wizard This will install MOXA UPort 1110 1130 Windows Driver Ver1 4 on your computer tis recommended that you close all other applications before continuing Click Next to cominus or Cancel to ext Setup ie Setup MOXA UPort 1110 1130 Windows Driver Select Destination Location Where should MOXA UPort 1710 1120 Windows Dinver be installed Setup will install MOKA U Port 117011730 Windows Dnver into the following folder To continue click Next IF pou would ike to select a different folder click Browse a OA At least 0 7 ME of free disk space is required Figure 47 MOXA driver installation folder Endo PAT2000 75 Operation Manual Itamar Medical Ltd 1 5 The following window will open press the Install button 7 ie Setup MOXA UPort 1110 1130 Windows Driver Ready to Install Setup it now ready to begin installing MOXA UPort 1170 1730 Windows Driver on your Computer Click Install to continue wath the installaton or cick Back if you want to review or change any settings Destination location C Program Files Moxa SB Diver Figure 48 MOXA driver folder confirmation 1 6 Press the Finish button F ie Setup MOXA UPort 1110 1130 Windows Driver Completing the MOXA UPort 1110 1130 Windows Driver Setup Wizard Setup has finished installing MOZA UFort 1170 1130 Windows Diver on pour computer Click Finish to ext Setup Finish Figure 49 MOXA driver ins
22. ER 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 i GRANT ITAMAR SOLE CONTROL OF THE SETTLEMENT COMPROMISE NEGOTIATION AND DEFENSE OF ANY SUCH ACTION AND ili PROVIDE ITAMAR WITH ALL INFORMATION RELATED TO THE ACTION THAT IS Endo PAT2000 64 Operation Manual Itamar Medical Ltd REASONABLY REOUESTED BY
23. 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 13 e Systolic Blood Pressure mandatory field 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 NOTE Study data is saved in a data file that 1s automatically named with the Patient ID number If the patient ID is for example 12345 then the file name will be 12345 s32 Endo PAT2000 29 Operation Manual Itamar Medical Ltd L
24. I x LT 2x Patient 1D Patient 1D Patient Name Patient Name Gender m Gender Age C Male 1 Female Age C Male Female m Blood Pressure mmHg m Blood Pressure mmHg Height E i Systolic 40 250 Height cm Systolic 40 250 Weight Ib Diastolic 20 200 Weight Ka Diastolic 20 200 Comments Comments User Field 1 AAA User Field 2 AAA User Field 1 ris User Field 2 ay Temp Nails Temp Nails PAT ographer v PAT ographer v Cancel New Patient Cancel New Patient Figure 22 Patient information dialog box metric and US units After clicking OK the Patient Information dialog box will close NOTE The computer s filing system will not allow the same Patient ID number for 2 different PAT studies Designate new Patient ID s for the same patient by amending the original Patient ID number with sequential letters For example 123456a 123456b etc When trying to use an existing ID number the following message appears Endo_pat2000 ed 8 1 ID already exists SS Enteranew ID Figure 23 File ID exists warning message A different ID must be entered before you can proceed Endo PAT2000 30 Operation Manual Itamar Medical Ltd 6 Conducting an Endo PAT2000 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
25. 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 fa ALL LICENSED SOFTWARE Ib ALL LICENSED PRODUCTS 85 DEFINED BELOW AND fe ALL THIRD TAT TTT Pat Hee TAT hs OTT ATTA SU aTTT AUT Tato antr CT do not accept the terms in the license agreement Figure 5 License agreement 5 Click Next to set the default target folder for software installation or click Change to select a different folder for the installation Figure 6 ie Endo PAT2000 Setup Destination Folder Click Mext to install to this folder or click Change to install to a different folder Install Endo P4T2000 ta Cr Tbamar Medical Figure 6 Installation folder selection Endo PAT2000 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 ie Endo PAT2000 Setup Ready to Install the Program The wizard is ready to begin installation Click Install ta begin the installation IF vou want to review or change any oF your installation settings click Back Click Cancel to exit the wizard
26. IONS 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 is 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 PAT2000 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 Endo PAT2000 62 Operation Manual Itamar Medical Ltd any copyright trademark logo or other proprietary
27. ITAMAR NOTWITHSTANDING 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 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 TA 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 forbidden and shall be null and void 8 SEVERABILITY
28. Itamar Endo PAT2000 User Manual Itamar Medical REF OM1695012 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 Copyright 2002 2009 by Itamar Medical Ltd Software Version 3 2 4 Itamar Medical Ltd This manual and the information contained herein are confidential and are the sole property of MI 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 PAT2000 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 Halamish St P O Box 3579 Caesarea 38900 Israel Tel 972 4 6177000 Fax 972 4 6275598 www itamar medical com SP US 0473 c So 13495 ISO 9001 2008 and I
29. SO 13485 2003 See appendix B for contact information of the regulatory authorized representative Endo PAT2000 1 Operation Manual Itamar Medical Ltd Record of Revisions Revision 14 0 uo Preliminary AA AA Update 6 May04 Update following FDA clearance All AA 8 May05 Update AppendixA All AY January 07 General update for new S W All All version arm supports and general overhaul of the manual version new USB to COM driver All 1 4 11 June 08 Updating ISO logo list of 1 4 standards Medes address 5 74 77 Adding of AI note Updating Itamar Medical address 1 64 65 73 ha July 09 General update for new S W All All version 3 2 4 Correction in caution note regarding power supply Corrections in installation of adaptor drivers Updated patent information Endo PAT2000 ll Operation Manual Itamar Medical Ltd Table of Contents 1 General Informatio sissisodan iiaii 1 1 1 Intended Purpose of the Endo PAT2000 smsmsmsmamanananmunununananuna 1 1 2 Performance and clinical study information s sssmusnsunmumusunananzunza 1 1 3 Equipment Classification 3 1 4 Manufacturers INOUICE ssassn niaranra e ad 3 1 5 Restrictions for USE ai ii AA AAA 3 1 6 Quality Assurance System ISO 9001 amp ISO 13485 cseeseeeeeeeeeeeees 4 1 7 Conventions Used in this Manual sscesesseeseeeeeeeseesenseesesensensen
30. 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 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 Quality Poor Signal Quality Program Failure Endo PAT2000 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 Table 5 Error messages 54 Operation Manual Itamar Medical Ltd 10 Technical Information 10 1 System Reguirements An IBM or compatible PC Pentium Celeron AMD 1000 MHz CPU
31. T2000 device Switch off the Endo PAT2000 device Plug the power cable to the Endo PAT2000 device Switch on the Endo PAT2000 device Verify that the orange LED is on Switch on the Endo PAT2000 device Verify that the communication cable is connected properly Close all background applications Verify that the COM port connected to the Endo PAT2000 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 Endo PAT2000 device Operation Manual Itamar Medical Ltd TI Noisy signal The probes do not deflate automatically after pressing stop The signal looks flat and does not react to gain amplification Endo PAT2000 Something is in contact with the probes or the tubes Either you neglected to press Go and thus still in the StandBy mode or there is a software hardware communication error The relevant PAT channel is not selected 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 t
32. The probe should not be used on a finger that is cut injured or unusually sensitive Fingernails should be trimmed and filed if necessary to avoid damaging the internal membranes of the PAT probes amp displaces 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 is too large to comfortably fit into Endo PAT2000 32 Operation Manual Itamar Medical Ltd the probe or is otherwise unsuitable see above a different finger except the thumb may be used as long as it is the same finger in both hands WARNING Long nails may cause distorted PAT signals and may cause the study to fail Before inserting the fingers into the probes ensure all heavy clothes tight fitting sleeves rings watches and jewelry were removed from the patient s hands and arms 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 6 2 2 Initializing the PAT system A
33. adaptor 3 2 Connect the COM TO COM cable to the ENDO device and tightly screw the bolts Figure 44 connect COM TO COM 3 3 Open the Endo PAT2000 software and verify that the PAT indicator on the bottom right is colored green Endo PAT2000 73 Operation Manual Itamar Medical Ltd Appendix D installing the USB adapter for Windows Vista This appendix describes how to install the MOXA adapter and driver for Windows Vista Enterprise edition NOTE The MOXA adapter must not be connected to the computer or to the Endo PAT2000 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 Vista driv_win_uportlp_v1 4_build_07100420_whda file NOTE If the following window is opened please press the Allow option User Account Control Fi Don t run the program unless you know where it s from or you ve used it before z j driv_win_uportlp vl4 build 07100420 whol exe Unidentifizd Publisher Cancel I don t know where this program is from or what it s for Details User Account Control helps stop unauthorized changes to your computer Figure 45 Windows Security Allowance Endo PAT2000 74 Operation Manual Itamar Medical Ltd 1 3 The following window will open press the Next Button i Setup MOXA UPort 1110 1130 Windows Driver Welcome to the MOXA UPort 11
34. al to baseline signal ratios at 14 consecutive 30 sec time ab ao segments for the occluded side suffix o MeanBL c Mean PAT signal amplitude in the baseline region of interest value for 6 the control side suffix C KI Post occlusion signal to baseline signal ratios at 14 consecutive 30 sec time aq bd segments for the control side suffix c be RecordingTime Date and time of test recording A AnalysisTime Date and time of test analysis bg RecordingVersion The software version used for the recording bi bj Site name amp PATographer identification 0 bl Commen bo FRA Table 3 table information Note fields E to J and BO will only appear in non US and in research versions only NOTE Please note that the Endo PAT analysis of Augmentation Index AI and FRHI are not FDA cleared and can be applied for clinical use out of the US only Endo PAT2000 45 Operation Manual Itamar Medical Ltd 7 2 1 Manual Selection of 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 on the occluded PAT tracing so that the curser points at the beginning of the occlusion Click and hold down the left mouse button and drag the mouse rightwards until the curser points at the end of the occlusion area The selected area will have inverted colors and as you mark it the length of t
35. 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 images will be reduced to fit the page Endo PAT2000 23 Operation Manual Itamar Medical Ltd Each of the 3 lines can contain up to 70 characters Report Appearance x Logo Set Logo Current Logo Clear Logo Figure 14 Report Appearance dialog box Clinique details Clinique details Clinique details Clinique details Clinique details Clinique details JJ Clinique details Clinique details Clinique details Endo PAT2000 Test Date 17 01 2006 08 59 48 Figure 15 The example for report header 10 The name of the operator performing the Endo PAT2000 study can be saved with the study data To create the master list from which the names are selected click the Set PATographer to open the following dialog box Endo PAT2000 24 Operation Manual Itamar Medical Ltd PA Tographer Information RAT ographer Name List of RAT ographers Remove OF Cancel Figure 16 The PATographer Information dialog box 11 Type the names of the PATographers in the top field and click Add after each one is entered When you finished entering all the names click OK to save the information and exit Click the Cancel button to exit without saving the changed information You
36. atch 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 Endo PAT2000 47 Operation Manual Itamar Medical Ltd The automatic analysis 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 3 for all the analyzed files 7 4 Manual Analysis 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 Research Mode Refer to section 4 4 1 7 4 1 Marking Segments and Artifacts Tool bar icons provide quick and easy access to the tools used to mark segments and artifacts as well as to facilitate automatic ratio calculations between PAT traces recorded at different time segments This feature can define any number of time intervals as artifacts and thereby exclude them from the ratio calcu
37. cent 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 4 Endo PAT2000 34 Operation Manual Itamar Medical Ltd Figure 25 Applying the PAT probes Make sure the tubing 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 25 3 Gently tape the tube to the tip of the anchor finger over the finger nail Figure 25 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 26 Figure 26 Hands set up Endo PAT2000 35 Operation Manual Itamar Medical Ltd 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 1 Click the Standby e icon from the main screen The system will display the signals from the two PAT channels allowing the user
38. ctivate the Endo PAT2000 application Enter patient details as required Please note that the ID should be specifically assigned to the subject and is going to be allocated as the file name for the recorded PAT study Ensure that the pneumo electric tubings are properly connected to the Endo PAT2000 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 Figure 24 will open tamar Medical Figure 24 Used probes warning Endo PAT2000 33 Operation Manual Itamar Medical Ltd WARNING The probes are single use and disposable they will not work properly if they have already been used 6 2 3 Patient preparation First ensure that a blood pressure cuff is placed on the upper arm of the designated test arm Then the PAT probes should be placed inside the appropriate sockets of the arm supports see Figure 25 1 Fully deflate the probes by clicking the 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 25 2 Inflate probes by pressing the Inflate button on the device or clicking the gl 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 adja
39. ded for 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 38900 Israel Facsimile 972 4 627 5598 or visit Itamar s web site at www itamar medical com Endo PAT2000 66 Operation Manual Itamar Medical Ltd Appendix B Regulatory Authorized Representative MEDES Ltd P O Box 231 5 Beaumont Gate Shenley Hill Radlett Herts WD7 7AR England Tel 423 663 169205 Tel Fax 44 1923859810 Endo PAT2000 67 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 PAT2000 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 Ready to Install Setup 13 now ready to begin installing MOA UPort 1110 1130 Windows Driver on Your computer
40. documentation accompanying the Licensed Software and the Licensed Product subject Endo PAT2000 61 Operation Manual Itamar Medical Ltd 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 PAT2000 and or the Endo PAT Software for the purpose of seeking or obtaining any regulatory approval from any governmental or 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 PAT2000 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 WITH THE REPORTING REGULAT
41. efore you must treat the Licensed Software and the Licensed Products like any other copyrighted and protected material or product All title to the Licensed Software and all intellectual property rights in and to the Licensed Software and the Licensed Products shall remain with Itamar Endo PAT2000 60 Operation Manual Itamar Medical Ltd 1 Definitions 1 1 Licensed Product s means the Endo PAT2000 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 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
42. er then click the Next button The following window is displayed Endo PAT2000 71 Operation Manual Itamar Medical Ltd Hardware Installation A The software you are installing for this hardware Port 1110 has not passed Windows Logo testing to very its compatibility with Windows sP Tellme 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 41 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 ndi UPort 1110 Click Finish to close the wizard Figure 42 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 Endo PAT2000 12 Operation Manual Itamar Medical Ltd 3 Connecting the adapter to the Endo PAT2000 Figure 43 connect MOXA
43. ety 5 Quality systems Model for quality assurance in design development production installation and servicing o oem ODI e carir ONT p ranoo Dn Endo PAT2000 4 Operation Manual Itamar Medical Ltd MDD 2007 47 EC Quality systems Medical devices System requirements for CAN CSA ISO regulatory purposes Health Canada 13485 1998 UL standard for safety UL 60601 1 Canadian Medical Devices Regulations SOR 98 282 1 7 Conventions Used in this Manual CSA standard for safety CSA 22 2 No 601 1 The following conventions are used throughout this manual Warnings Are used to identify conditions or actions which if the instructions are ignored may violate patient safety or could cause damage malfunction of the system resulting in the irretrievable loss of data Cautions Are used to identify conditions or actions that could cause interference with data acquisition and or impair study results Notes Are used to identify an explanation or to provide additional information for purposes of clarification There are no additional warnings and cautions other than those provided in the appropriate sections of this manual Physicians nurses and medical technicians should read the Endo PAT2000 Operation Manual carefully before operating the system All pictures are for illustrative purposes only Endo PAT2000 5 Operation Manual Itamar Medical Ltd 1 8 Safety Precautions WARNING Only
44. eview see next chapter 6 3 5 Setting time markers Time markers can be inserted manually into the data while recording This is used only for manual data analysis as described in section 7 4 To insert a time marker press any of the 10 number keys on the keyboard The time marker cannot be erased after it 1s set However it does not interfere with the data You can set as many markers as you like Endo PAT2000 41 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 gualitative evaluation can be performed However subseguent 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 1 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 ir B Tutorial o d fe Mame Size Arrhythmia and incomplete oc 6 654 KB E Baseline too short s32 3 468 KB Endothelial Dysfunction 532 7 067 KB Incomplete Occlusion 532 5 077 KB E Normal Endothelial Function 532 8 006 KB Ej User dependent noises 532 12 042 KB Type S32 File S32 File S32 File S32 File 532 File S32 File Date Modified 2210312006 10 18 30 03 2003 18 44 16 02 2006 09 01 21 12 2004
45. he 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 PAT2000 device If you were in Standby 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 13 Table 4 Troubleshooting 53 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 n 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
46. he selected period will be marked just below Probel or Probe2 on the left hand side of the screen in blue Release the mouse button From 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 Point the mouse at the beginning of the occlusion area Right click on the mouse will Open a popup menu Figure 32 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 Point the mouse at the beginning of the occlusion Right click to open a popup menu Figure 32 Set Automatic 5 mip Geclusian Set Stark Occlusion Marker Set End Occlusion Marker Ciccluded Probet Occluded probe Clear Occlusion Figure 32 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 Endo PAT2000 46 Operation Manual Itamar Medica
47. ia hawa 23 Figure 14 Report Appearance dialog Doa Aa 24 Figure 15 Theexample tor report header cnc ion ieee eee 24 Figure 16 The PATographer Information dialog DOX wewnennnnnnnnna 25 Pove SCOM port Sear WAA AA AAA eeu ace ease KT 27 Picur Ss InserUne IMO SIU AA N 28 Poire 9 eC CK SNS ai 28 Peur 2 Ws Press 10 Wel CAG AU asta cust nasecedare E E 28 Figure 2 i Prope disconnected AA aetna 28 Figure 22 Patient information dialog box metric and US units 30 Endo PAT2000 vi Operation Manual Itamar Medical Ltd Froure 23 File ID exists warning IMCSSa ia 30 VIWA Used probes WINN ia 33 Fisure 25 Applying he PA Ti Aa 35 Peur Or A INS Sb UO octet sate tia se ada act rast atte act AA WA AA eaasetaniedae 35 Pisure r Slama By Mode nee AAA AAA easaniaitenteeats 37 Figure 26 ReCOUC AA EA 38 Froure 29 Occlusion Quality assessment ina 40 Feur 50 s Open INSA DA AA NAE 42 KUA AMO MASAA Ii AA ad 43 Pisure32 Occlusion POPUP MU 46 Figure 33 Marking Segments and Artifacts vvveessmnnnnanannanenewenenewenwa 49 Figure 34 MOXA USB Installation KP 1 wewemevenennnnaanannanenewwwwwwmwwa 68 Figure 35 MOXA USB Installation XP2 esssssssssssseeccccccccccccceceeeeeesesesseees 69 Figure 306 MOXA USB Installation XPS seein totion corso a 69 Figure 57 MOXA NG apter AKA 70 Figure 38 MOXA Adapter Configurat
48. ifact in 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 Service Table 1 4 3 Main Screen Tool Bar Main screen pull down menu commands 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 PAT2000 19 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 e Mark segment as artifact in Research mode only Table 2 Tool bar buttons and functions Endo PAT2000 20 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 11 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 corresponding trend
49. ion KPJZ2 w w wenneennnnanannnewennnnnnnna 70 Figure 39 MOXA Adapter Configuration XP3 cccccccseeeeeeccececceeeeeeeaeaeeeeeeeeeees fal Figure 40 MOXA Adapter Configuration XP4 cccccccceceececeececeeeeeeeeeeeeeeeeeeeeees 71 Figure 41 MOXA Adapter Configuration KPD vvwweennnnnananannnenenwwmwmenwa 72 Figure 42 MOXA Adapter Configuration KPCO vvvwwssnnnnanannnnnnnewenenewenwa 72 Fisure43 conmect MOXA ai AA EA 73 Figure 44 connect COM TOCOM scurs ae E igs eat dceadiabed mamlinend ages 73 Figure 45 Windows Security AlloOwance wwwmewmennnananannnnnewewememewen a 74 Figure 46 MOXA Uport driver installation wi ii aba leka wakaa 75 Endo PAT2000 vii Operation Manual Itamar Medical Ltd Figure 4 MOXA Jr installation KM IA 75 Figure 48 MOXA driver folder Confirmation cceccssseeeeeecceceeeceeeeeeeaaeeeeeeeeeeeeees 76 Figure 49 MOXA driver installation finish v weeeeememenemenanannmw 76 Fiure 30 Dine MONA A Ia 77 Figure gt connect MO KA aa EA E 78 Figure 52 connect C OM OO MA oul Siaeaneactedae ea headeeaawss 78 List of Tables Table 1 Main screen pull down menu COMMANAS ccccccccccccesseeeeeeceeeeeeaaaeeeeeeceeeeeeeaas 19 Table 2 Tool bar buttons and functions weme
50. l support itamar medical com CIA 0 ACE G 0473 12V DC 1A Made in Israel Must be used with software version 2 3 2 or higher Packaging labels The following labels are attached to the package of the Endo PAT2000 system Endo PAT2000 57 Operation Manual Itamar Medical Ltd Endo PAT2000 Probe Package tamar prises tor aoran CO Oke Itamar Medical Ltd 9 Halamish POB 3579 Caesarea Ind Park Israel Tel 972 4 6177000 Fax 972 4 6275598 www itamar medical com Endo PAT2000 58 Operation Manual Itamar Medical Ltd 10 5 Specifications for Endo PAT2000 PAT Probe Itamar s proprietary probe only minutes sett ne ie aires eae me Output tev 3A Storage we AA 10 95 non condensing Lx Wx H max 240mm x 135 mm x 185 mm Table 6 Specifications Endo PAT2000 59 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
51. l 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 32 e Once the manually selected occlusion is marked click on the Al 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 32 7 3 Batch Analysis The Endo PAT2000 allows the user to perform a b
52. lations 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 NOTE While marking segments and artifacts errors may be corrected by clicking the 4 icon Clear all segments This will also erase the occlusion border markings This tool should be used only when using the manual options described in this chapter To Mark a Segment 1 Inthe Trace Window position the mouse pointer at the beginning of an interval to be marked Endo PAT2000 48 Operation Manual Itamar Medical Ltd 2 Drag the mouse 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 T Endo PAT A000 lamar Memeo aT utira 1 abe ones 2 File AT Cernte Tet Seats Help wa Ee j an a i Ss Toate ae a ele ojejo mmm aaja aa aa l 2 E ii Kia Lhe PE rack PT Se Time ladle E TE FORTET esi 24 Study Date 12 08706 Baseline Test Test B aseline segment Segment ratio Figure 33 Marking Segments and Artifacts 4 Set the highlighted segment to B T or artifact as appropriate Select a segment and click Leal icon to mark it as the B segment B segment traces are highlighted in green Select a segment and click on the Lal icon to mark it as a T segment T segment t
53. ls 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 design materials or workmanship This
54. mities which preclude adequate signal acquisition e Patients under the effect of short acting NTG 3 hours washout period e The Endo PAT2000 system in whole or in part may not be modified in any way 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 Itamar 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 PAT2000 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 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 Medical electrical equipment general requirements for safety IEC 60601 1 Medical electrical equipment electromagnetic compatibility IEC 60601 1 2 2 3 Programmable electrical medical system Requirements for IEC 60601 1 4 saf
55. mmunication with the device going through COM ports 1 to 10 in a cyclical manner This continues until communication is established or Work Disconnected is selected Communication Search E a Searching for communication COM CO1 H COM3 If device i connected to serial port above COMI o then please select Work Disconnected and set COM port manually through Setup Balog Figure 17 COM port search 5 2 Connecting the PAT Probe Connect two new probes by inserting the connector tab into each probe slit see Figure 18 and pressing the connector down onto the probe until the tab of the probe clicks into place see Figure 19 Endo PAT2000 27 Operation Manual Itamar Medical Ltd Figure 18 Inserting into slit Figure 19 Clicking in To remove probes press the tab clip marked by the arrow in Figure 20 and then lift the connector away from the probe Figure 21 Used probes should be disposed of properly Figure 20 Press to release Figure 21 Probe disconnected 5 3 Creating a Patient File 1 Click the icon on the tool bar or activate from the Test Analysis menu the Patient Information dialog box See Figure 22 2 All mandatory fields 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 Endo PAT2000 28 Operation Manual Itamar Medical Ltd e Patient First and Last name
56. n area appears wrong it can be manually selected as described in section 7 2 1 Endo PAT2000 43 Operation Manual Itamar Medical Ltd NOTE After launching the Endo PAT2000 software you should wait 10 seconds before running the first test analysis This is necessary to allow termination of background processes The Endo PAT2000 study results RHI amp HR are presented on the right side of the screen Figure 31 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 The HR Heart Rate is calculated from the PAT signals in the baseline region of interest To review the results of the study click the E icon 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 3 is a description of the information fields displayed in the table Endo PAT2000 44 Operation Manual Itamar Medical Ltd fe Al Augmentation Index Al 75 Augmentation Index normelized to HR 75bpm lg Al_N pulses number of pulses averaged to calculate the Al Baseline duration region of interest ROI duration and total study duration ae MeanBL o Mean PAT signal amplitude in the baseline region of interest value for the occluded side suffix o bee Post occlusion sign
57. nenennnnenewe 20 esed CMV SL SIOMS OU retired sciasa siesta ial Gud sim dias AA AA AMA AA UA 45 LaDple 4 TLOUDICS NOG AI KAA r AU a N 53 Tables Eror Message AAA AAA NAA 54 TaD 6 5 pe e ONE oan a E EE E E E 59 Endo PAT2000 viii Operation Manual Itamar Medical Ltd 1 General Information This manual is part of the Endo PAT2000 system 1 1 Intended Purpose of the Endo PAT2000 The Endo PAT2000 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 PAT2000 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 PAT2000 device is not intended for use as a screening test in the general patient population It 1s intended to supplement not substitute the physician s decision making process It should be used in conjunction with knowledge of the patient s history and other clinical findings 1 2 Performance and clinical study information The following sensitivity and specificity data were revealed from a clinical study that was performed at
58. nts 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 Endo PAT2000 2 Operation Manual Itamar Medical Ltd 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 Criteria for exclusion e Deformities of fingers that preclude adequate signal acquisition with the Endo PAT2000 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 3 Equipmen
59. o PAT2000 version 3 2 4 sus TIWA 0 00 00 00 15 Figure 28 Recording 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 lines 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 Endo PAT2000 38 Operation Manual Itamar Medical Ltd 6 3 2 Performing arterial occlusion After a stable period of baseline signal recording prepare for the occlusion l 2 Change the time scale to 15 seconds 00 00 15 Amplify the signal gain of the occluded arm either probe 1 OR probe 2 to 20 000 If a stop watch will be used during the occlusion set it for down counting from 5 minutes Explain the procedure to the patient stressing the importance of remaining still during the test despite the transient strange sensations 1 e numbness they might feel in their arm 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
60. o your USB port Figure 37 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 Yes this time only 0 Yes now and every time connect a device No not this time Click Next to continue c so Core Figure 38 MOXA Adapter Configuration XP2 2 3 Select the No not this time option and click the Next button The following window is displayed Endo PAT2000 70 Operation Manual Itamar Medical Ltd Found Mew Hardware Wizard This wizard helps you install software for UPort 1110 If pour hardware came with an installation CD lt 2 or floppy disk insert it now What do you want the wizard to do gt Install from a list or specific location Advanced Click Next to continue Figure 39 MOXA Adapter Configuration XP3 2 4 Select the Install the software automatically Recommended option then click the Next button The following window appears Found Mew Hardware Wizard Please wait while the wizard searches Si UFort 1110 Figure 40 MOXA Adapter Configuration XP4 2 5 Wait for the installation wizard to find the UPort 1110 driv
61. package can be used with any IBM compatible computer running English versions of Windows XP and Windows Vista The automatic analysis module requires any type of internet browser or Excel 2000 2003 For details regarding hardware and software requirements refer to System Requirements in Section 10 1 Although individual system set ups may vary Figure represents a typical setup of a study Endo PAT2000 Figure 1 Typical set up 9 Operation Manual Itamar Medical Ltd 3 2 System description The Endo PAT2000 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 i USB to COM ON OFF Switch The front panel has two pneumatic input connectors for attaching the pneumo electric tubing connecting the PAT probes to the Endo PAT2000 device The back panel has Figure 2 Figure 2 Endo PAT2000 e Power supply DC connector e Communication port e ON OFF switch Endo PAT2000 10 Operation Manual Itamar Medical Ltd 3 3 Connecting the Endo PAT2000 to the Computer NOTE The Endo PAT2000 system requires the use of a USB to Serial adapter The Endo PAT2000 can alternatively be connected to a serial COM port in the computer with a standard 9 pin RS232 cable 1 Place the Endo PAT2000 and computer in close proximity to the examina
62. pressure by an additional 50 mmHg and up to 300mmHg See Figure 29 Click the kuj 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 occlusion period began Thus you will not know when to release the occlusion 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 Endo PAT2000 39 Operation Manual Itamar Medical Ltd NOTE Once the occlusion has been performed the test should not be re started 1 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 Left complete occlusion Right incomplete occlusion In both panels the bottom signal is the occluded arm Figure 29 Occlusion quality assessment 6 3 3 Post Occlusion period 1 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
63. r computer after installation of the Endo PAT2000 software and the RS 232 to USB adaptor driver When the driver installation is completed connect the USB adaptor to the computer and start the Endo PAT2000 software refer to section 4 The software will search for the appropriate communication port to communicate with the connected RS 232 to USB adaptor as described in section 5 1 Note Refer to the configuration section Section 4 4 for setting the configuration of the COM port Endo PAT2000 15 Operation Manual Itamar Medical Ltd 3 6 Uninstalling Endo PAT2000 Software Enter the computer s Control Panel and select the Add Remove programs option Select the Endo PAT2000 software and press remove 3 7 Shutting Down the System 1 Shut down the Endo PAT2000 software program by selecting the Exit on the pull down File menu 2 Switch OFF the Endo PAT2000 device using the on off switch on the back panel Endo PAT2000 16 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 9 2i Endo PAT2000 E laf x Eile PAT Control Test Analysis Help s S w ele ojejo x mamala ol lui mH Itamar Medical Ltd Endo PAT2000 version 3 2 4 AA S pe Pe Ta Figure 9 Main screen The Main Menu Screen is the gateway to the functions of the Endo PAT2000 software The th
64. races are highlighted in red Select segments suspected as artifacts and click on the Lal icon to mark as an artifact segment multiple segments can be selected artifact segment Endo PAT2000 49 Operation Manual Itamar Medical Ltd 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 33 NOTE m If there are noise artifacts in the region of interest in the signal you should first 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 4 2 Analyzing PAT Ratios After the B and T segments are marked their PAT ratios are automatically calculated and the results displayed in the right side of the screen Figure 33 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 33 do not have any clinical implication This feature is used only for research purposes and should not be regarded as device output concerning Endothelial Dysfunction 7 5 Study report amp printing You can print the displayed data at any time during off line review and
65. ree 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 Endo PAT2000 17 Operation Manual Itamar Medical Ltd e Tool bar section 4 3 e Scroll bar section 4 3 2 2 Display windows e Channels identification column for the PAT waveforms and Trend traces e PAT waveforms and Trend traces 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 PAT2000 software a dialog box Figure 10 will open Click the OK button to enter the Setup menu Complete the setup as described in section 4 4 Endo PaT 000 Figure 10 Fill site name dialog box Endo PAT2000 18 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 PAT2000 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 Setup parameters Open Patient Information dialog box Automatic Analysis Select occlusion period Select Baseline Segment in Research mode only Select Test Segment in Research mode only Mark segment as art
66. riod 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 is 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 Endo PAT2000 8 Operation Manual Itamar Medical Ltd 3 Installing the System 3 1 Basic System Configuration The Endo PAT2000 is supplied as a complete package comprising the following components e One Endo PAT2000 device e One Endo PAT2000 software CD e Three pneumo electric tubing 2 tubes 1 spare e Power adaptor e Power cable e Operation manual e Set of 6 foam finger anchors The supplied Endo PAT2000 software
67. rol and then click Setup Inflate Deflate atop SBEUC 5 Figure 12 The setup command 3 The following screen will appear Endo PAT2000 22 Operation Manual Itamar Medical Ltd Serial Port Pressure Control FAT COM com v Check com f Fixed Pressure mmHg 70 Diastolic blood pressure dependent Automatic Search COM1 COM10 Site name fitamarm edical PAT Channels P Probe Trendl W Probe ll Trend II Countdown Clack Start Time min 5 v Set FATo Report Setup Cancel Figure 13 The setup dialog box 4 Click Automatic Search COM1 COM10 to allow the system to automatically identify the COM port to which the Endo PAT2000 is connected 5 If the automatic search fails you can select or type the correct COM port for the Endo PAT2000 manually in the relevant field After selecting the desired COM port verify communication by clicking Check COM 6 Inthe PAT Channels frame select which channels should be displayed on screen For normal operation both PAT channels should be selected 7 The Countdown Clock timer is set to 3 minutes by default To change this value 1 through 15 select the appropriate value from the drop down menu 8 To enable the Research mode select the Research mode checkbox The entire Test analysis menu is enabled 9 To configure the report press the Report Setup button This will open the report
68. seneeeens 5 1 8 Safety Precautions ssamananana nanunua akakana manana Kanana aua Na aKa Kanana nana Kanana nWa 6 2 System Overview AA 8 21 How to Use this Manual nnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnn 8 3 Installing the System csscsccseeseesenscnseneesensensensenseneesensens 9 3 1 Basic System Configuration ccccccccesceseeeseeseeseeseeseeseeseeseeseeseneensonsensenees 9 3 2 System descriptionN s ss 10 3 3 Connecting the Endo PAT2000 to the Computer ccsccesesseeseeeeneeeeees 11 3 4 Endo PAT2000 Software Installation cccsceseeseeseeseneesenseeseeeeeeeees 12 3 5 Installing the RS 232 to USB ad aptor c ccccccseeseeseeseeeeeeeensensneeneeneeneens 15 3 6 Uninstalling Endo PAT2000 Software c ccsccesscessesseessensenseessensenssenees 16 3 7 Shutting Down the System cccccescesseessessenseensenseessenseeseensenseensonseesenaes 16 Endo PAT2000 iii Operation Manual Itamar Medical Ltd 4 Software Description jsietocccisccteectenecsccariieeeesreaiencelibenseekacence 17 4 1 IND ANI SCPC i E A 17 4 2 Main Screen Menu Commands 1 esseseeeseesensensensenseeeeeseeseessensensenes 19 4 3 Main Screen Tool Baf vcs ccecce 255 cs ecg coveted toestaes tbcetens doen ees ceestecicaes tec teencads 19 4 4 Configuring the System 21
69. t Classification The Endo PAT2000 is classified as a Class Ila 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 PAT2000 is classified as Class II medical device 1 4 Manufacturers Notice The information in this document is subject to change without notice Itamar Medical Ltd makes no warranty of any kind on this material including but not limited to the implied warranties of merchantability and fitness for a particular purpose Itamar Medical Ltd shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing performance or use of this material This document contains proprietary information which is protected by copyright All rights reserved No part of this document may be photocopied reproduced or translated without the prior written consent of Itamar Medical Ltd 1 5 Restrictions for Use e Only qualified medical personnel may authorize the use of the Endo PAT2000 e Inthe event of equipment malfunction all repairs should be executed by authorized Itamar Medical Ltd personnel or licensed service agents e The eligibility of a patient for a PAT study is generally based upon the patient s medical status The following should not be considered for the PAT study Endo PAT2000 3 Operation Manual Itamar Medical Ltd e Deformities of the digits of the upper extre
70. tall previous Endo PAT2000 software versions prior to installing a newer version To uninstall the software please refer to section 3 6 Make sure to backup all your data prior to uninstalling any software 2 Insert the Endo PAT2000 software CD into the computer drive The installation program will load automatically Alternatively the user may select the setup exe command from the CD drive 3 The Install Shield prepares the computer for installation When prompted click next to proceed with the installation Figure 4 ig Endo PAT2000 Setup Welcome to the InstallShield Wizard for Endo PAT 2000 The InstallShield Rj Wizard will install Endo PAT2000 on your computer To continue click Net Attention A user with full administrator permissions must preform this installation if you do not have such permissions please cancel installation now WARNING This program is protected by copyright law and international treaties Figure 4 Install shield wizard Endo PAT2000 12 Operation Manual Itamar Medical Ltd 4 Read the license agreement and select the I accept option to agree to its terms and continue with the installation by pressing next Figure 5 Click I do not accept if you do not accept the terms of the agreement and wish to abort the installation ie Endo PAT2000 Setup License 4greement Please read the Following license agreement carefully LICENSE AGREEMENT License To User From Itamar
71. tallation finish Endo PAT2000 76 Operation Manual Itamar Medical Ltd 2 Configuring the MOZA Adapter 2 1 Plug in the adapter to your USB port Figure 50 The MOKA 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 x fy Installing device driver software Click here For status 2 3 When the installation of the driver is done the following message should appear aL Your devices are ready to use Device driver software installed successfully Endo PAT2000 77 Operation Manual Itamar Medical Ltd 3 Connecting the adapter to the Endo PAT2000 3 1 Connect the MOXA Adapter to the COM TO COM cable and tightly screw the bolts e e e Figure 51 connect MOXA adaptor 3 2 Connect the COM TO COM cable to the ENDO device and tightly screw the bolts Figure 52 connect COM TO COM 3 3 Open the Endo PAT2000 software and verify that the PAT indicator on the bottom right is colored green Endo PAT2000 78 Operation Manual
72. the power supply that is provided within the EndoPAT 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 PAT2000 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 PAT2000 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 PAT2000 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 Endo PAT2000 Operation Manual should be carefully studied by the authorized operators and stored where it is easily accessible Periodic review of the manual is recommended 5 The Endo PAT2000 is a whole system To eliminate risk of electrical shock do not attempt to open or remove system covers or pl
73. thelium dependent coronary flow reserve is calculated as percent change in CBF in response to the Ach challenge Normal coronary endothelial function is defined as an increase in CBF of 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 PAT2000 relative to a gold standard procedure as a diagnostic aid for detecting coronary endothelial dysfunction Methodology Patients who had been referred to diagnostic angiography cardiac catheterization laboratory for diagnostic angiography secondary to signs or symptoms of ischemic heart disease and suspected coronary endothelial dysfunction and were found to have normal or near to normal angiogram underwent Intra coronary Acetylcholine Ach challenge test to assess attenuation in required increases to coronary blood flow CBF and coronary artery diameter CAD where each of these parameters served as an indicator for coronary endothelial dysfunction Coronary endothelial dysfunction is diagnosed if one of the following changes is observed in response to the Ach challenge test ACBF lt 50 OR ACAD lt 20 Patie
74. tion 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 COM adapter to the communication port on the Endo PAT2000 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 PAT2000 and computer and tighten the connecting screws 3 Connect both pneumo electric tubing to the Endo PAT2000 front panel pneumo electric connectors and secure by hand tightening the screws see Figure 3 4 Make sure the power switch is off Connect the power supply first to the Endo PAT2000 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 Endo PAT2000 11 Operation Manual Itamar Medical Ltd 3 4 Endo PAT2000 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 PAT2000 software NOTE Unins
75. 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 27 for at least 1 minute If the signal 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 Standby mode for a few more minutes until at least a minute passed since the last leak or refer to the troubleshooting section section 9 NOTE If you are in the Standby mode it is possible to stop the test deflate amp re inflate the probes without losing the usability of the probes Once a is pressed the probes cannot be reused after the u button is pressed Endo PAT2000 36 Operation Manual a M m mmg enyi Jj a Stan iB mi ode JI uM y ii ii uuu IA UU UU ww Endo PAT2000 37 Operation Manua Itamar Medical Ltd NOTE Cold fingers amp small fingers will have small PAT signals with higher noise levels 3 Initialize the stopwatch by clicking the kuj Icon BEI File PAT Control Test Analysis Help NT M ACTA j i Itamar Medical Ltd End
76. ugs 6 Do not operate or activate mobile phones or other devices capable of causing electro magnetic interference nearby the system 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 Endo PAT2000 6 Operation Manual Itamar Medical Ltd Do not allow fluids to come in contact with the pneumatic connection in the device 9 Do not operate the equipment in the presence of explosive liquids vapors or gases 10 In the event that the system does not operate properly or if it fails to respond to the controls in the manner described in this manual the operator should contact customer support 11 Do not apply the probe to an infected finger or wounded skin 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 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
77. warranty does not cover damage which may occur in shipment This watranty 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 Endo PAT2000 63 Operation Manual Itamar Medical Ltd 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 reguirements or that the operation of the Licensed Software will be uninterrupted or error free Itamar is 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 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 APPLICABLE LAW EXCEPT FOR DAMAGES ARISING UND

Endo_PAT user manual for 3 2 4

Contents

Download Pdf Manuals

Related Search

Related Contents