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CloudPAT Web Software Operation Manual

1. fone Men heres tates me Manual Upload Please zip compress the following files from the WatchPAT device Patient dat Sleep dat Log dat if it is exists into a single file then press choose file select the file and press Next to continue comba Me Ci Browse Di 9 The exported file from the zzzPAT will end in zzp Select the file that you want to upload and select Open Then click the next button 10 Depending on your connection speed to upload and the size of the study data file the upload time will vary between 2 and 5 minutes If an error is reported you will need to try again 11 Assign the study to an Interpreting Physician Then click Next Home Settings Support Logout tamar Home View Reports Patients Manage Lists Upload Study Select Interpreting Physician Select Interpreting Physician from list then press Next Patient EM SurfaceProbejig Office MusbaOffice Physician X Nes 12 The following screen will appear and the process is complete CloudPAT Page 53 Operation Manual Itamar Medical Ltd Home Settings Support Logout itamar C pload Complete gt Complete Study uploaded successfully The analyzed data file will be ready shortly under Reports Data will be sent to be reviewed by Musba Efrat CloudPAT Page 54 Operation Manual Itamar Medical Ltd 7 Appendix B Interpretation and editing of events by the Interpreting Physician Guide Note
2. m Fill STOP Note Once the patient starts filling in the O BANG questionnaire they have 20 minutes to P E complete it If they don t complete it during ea eels that time a new code must be generated E ees from within the Patient Details screen M rubet 0 TT e Select the Submit button once the patient has filled in the questionnaire e The Patient details will be automatically updated with the new information except if the fields were already filled previously e Filled questionnaires can be viewed from the Questionnaires section of the Patient details screen CloudPAT Page 65 Operation Manual Itamar Medical Ltd 9 Appendix D License Agreement 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 INTO WHICH A LICENSED PRODUCT OR LICENSED SOFTWARE IS INCORPORATED SHOULD YOU HAVE ANY QUESTIONS CONCERNING THIS LICENSE AGREEMENT PLEASE CONTACT THE VENDOR FROM WHICH YOU PURCHASED THE LICENSED SOFTWARE LICENSED PRODUCT OR PRODUCT INTO WHICH A LICENSED PRODUCT OR LICENSED SOFTWARE IS INCORPORATED YOU MAY ALSO CONTACT ITAMAR AT THE ADDRESS PROVIDED AT THE END OF THIS LICENSE AGREEMENT
3. zzzPAT Login clica 5A n Login Type C Active Directory Service ADSI Open zzzPAT O e ba Start zzzPAT default Login and Password 111 for both entries Start Export i l process Select Export Delete under Tools Find a patient Highlight the patient that you want to via ID export to CloudPAT and select Export for number Interpretation c 9 prar s o ab um a T o o gt lt LLI b ab um o gt O UD O o l CloudPAT Page 61 Operation Manual Itamar Medical Ltd ETT Browse for a Folder you created prior to this step suggestion name Save it CloudPAT Exported file After selecting that Folder Save the exported file by selecting OK The file will end in zzp Save Export Log into CloudPAT like a regular study www cloudpat precisemd com Enter your Username and Password Select Sign In Log into CloudPAT Manual Study Select Upload Study Manual Upload Upload Select Switch to Manual Upload ae en Pt o er se co t Find the file select Browse gt s The file extension is zzp Proceed as in Select Open for the file you want to normal upload Upload Proceed as in Step 3 for a regular Upload Sleep Study CloudPAT Page 62 Operation Manual Itamar Medical Ltd Interpreting Physician Physician review of raw sleep study data
4. Home View Reports Patients Manage Lists Select Interpreting Physician Select Interpreting Physician from list then press Next Patient Dana Dana M Office MusbaOffice Interpreting D Physician E Ses Y Figure 22 Select Interpreting Physician Dialog box CloudPAT Page 25 Operation Manual Itamar Medical Ltd Note Users connected to two or more offices might be asked to select an office for the upload At the end of the upload process you will receive the message Upload Complete Study uploaded successfully The analyzed data file will be ready shortly under View Reports If the data was assigned to be sent to an Interpreting Physician the message will also include Data has been sent to be reviewed by Interpreting Physician s name see Figure 23 E Home Settings Support Logout itamar vedi di Oe YOU m Y ke o Home View Reports Patients Manage Lists Create New Study Upload Complete Study uploaded successfully The analyzed data file will be ready shortly under Reports Data will be sent to be reviewed by Musba Efrat Figure 23 Upload complete screen If an error is reported you will need to try again see Figure 24 e Home Settings Support Logout itamar m TATE vetoad raitea Failed Upload was unsuccessful please check that the WatchPAT device is connected securely and try again If this error persists please contact customer support at 888 Xxx xxxx Figure
5. Note In a multi night study a manual events file might be created for each of the nights Upload all of them into the cloudPAT Add files by pressing the icon CloudPAT Page 58 Operation Manual Itamar Medical Ltd 8 Appendix C CloudPAT Assistant cheat sheets You may print the following pages for a quick reference to frequent tasks Create a New Study Initialization via CloudPAT L1 Actionis Do you have Before you 1 PC workstation w internet access Problems or Questions start 2 Internet Explorer 7 0 or higher Select Support or 3 Username amp Password Call 1 888 748 2627 4 Minimum upload speed of 1 Mbps Enter Log in to www cloudpat precisemd com CloudPAT e Enter your Username amp Password via the Web Select Sign In Create e Select Create New Study initialize Slide WatchPAT device out of its new Sleep cradle to reveal the USB connection Study using e Connect WatchPAT device to any USB CloudPAT port e Only the Patient ID and office are l mandatory Patient e We recommend you fill the patient name Detail Entry to ease searching for the study e Select Save amp Initialize Device e For more patient detail entry select More Details section OF UONAL e Select the box Bracelet Study for Chain of occupational testing using a Chain of Custody Custody bracelet Bracelet e For multi night study select the number of ni
6. The system is ready for Upload Please check that the WatchPAT device is connected and click on proceed to continue with Upload Switch to Manual Upload q Proceed with upload Figure 19 Upload Study Dialog box A small PC resident program will be downloaded the first time remote access is requested from CloudPAT see Figure 16 and select Run During the upload process you will see a screen informing that upload is in progress Note When a multi night study is loaded all the night recordings are loaded automatically While uploading the following dialog see Figure 20 will be displayed CloudPAT Page 24 Operation Manual Itamar Medical Ltd Itamar Medical Watch PAT devi Please wait while study data is 1 t ama uploaded from device medical Figure 20 Patient sleep study upload in progress Note Depending on your connection speed to upload the number of nights included in the study and the type of device the upload time will vary between 2 and 15 minutes Tamar Medical Watch PAT devici Study uploaded successfully The study was sent to analysis and will be ready for review shortly Figure 21 Successful upload screen If upload is successful you will be asked to approve or change the Interpreting Physician selection see Figure 22 from a list of Interpreting Physicians which were defined for your office p Home Settings Support Logout itamar
7. part 1 E n Do you have 1 Computer running Win7 or higher with internet access Internet Explorer 7 0 or higher Problems or Questions Select Support or Call 1 888 748 2627 Before you start Import Study Enter CloudPAT via the Web Select patient study View auto analyzed suggestions Analyze amp save Sleep Study raw data Start zzzPAT Manual Study Upload CloudPAT 2 3 Username amp Password 4 zzzPAT familiarity amp installed Log in to www cloudpat precisemd com e Enter your Username amp Password e Select Sign Ir You may e Analyze a study Studies or e Create custom forms Templates or NPI number NPIS Select the patient you want to analyze Various Sort options are available at the bottom To view the auto analyzed 2 page report that the Provider uploaded select Analysis File To view patient information select Preview Report e Open attachments if exist If analysis is satisfactory skip to step 12 To download the raw data for review e Select Download to zzzPAT e Browse for a Folder you created prior to this step suggestion name it CloudPAT Open zzzPAT default Login and Password 111 for both entries Select Import Packed studies under Tools Get to Select Packed Studies to Import Go to your previous CloudPAT Folder Highlight the zzp file to Import Select Open Edit S
8. and REM Light Sleep and Deep Sleep stages CloudPAT offers simple preparation and uploading of WatchPAT sleep studies that can be sent transparently for interpretation by a local Interpreting Physician or from a national network of telemedicine to a Board certified Interpreting Physicians After interpretation the sleep study results will be attached to the patient s record The regular comprehensive WatchPATTM sleep study report is available for printing export and analysis All data is securely stored and backed up on the Web CloudPAT Page 7 Operation Manual Itamar Medical Ltd 1 4 Overview Obstructive sleep apnea syndrome OSAS is considered a major public health problem The prevalence of the syndrome is estimated at 2 to 5 in the adult population It 1s characterized by recurrent events of complete or partial obstruction of the upper airways during sleep often leading to hypoxemia and or arousals associated with sympathetic nervous system activation The diagnosis and assessment of the sleep apnea patient is based on the Respiratory Disturbance Index RDI the number of Apneas Hypopneas and Respiratory Effort Related Arousals RERA per hour of sleep and or apnea hypopnea index AHI along with sleep architecture The common consequences of this sleep disruption are daytime sleepiness poor daytime performance and increased vulnerability to accidents Cardiovascular complications such as systemic pulmonary hypertensi
9. and body position discrete states from an external integrated snoring and body position SBP sensor The device s PSTAGES and SBP provide supplemental information to its PRDI PAHI The device s PSTAGES and SBP are not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder prescribing treatment or determining whether additional diagnostic assessment 1s warranted 1 2 ZZZPAT S W Definition ZZZPAT is an analysis software package used with the WatchPAT device to aid in diagnosis of sleep related breathing disorders and detects REM Light Sleep Deep Sleep and Wake stages The zzzPAT S W displays the signals recorded by the WatchPAT device automatically identifies breathing disordered events and REM Light Sleep Deep Sleep stages and generates a comprehensive report for the physician 1 3 CloudPAT S W Definition CloudPAT is a HIPAA compliant PL104 191 web based cloud application used for managing the diagnosis and treatment of sleep apnea It offers individual physicians or large organizations the ability to control the process of sleep disorder management seamlessly and electronically in a turnkey fashion In its basic implementation CloudPAT is a parallel adjunct to the local ZZZPAT sleep analysis software sold separately with WatchPAT device CloudPAT uses zzzPAT s analyzing software modules that are responsible for the identification of the breathing disordered events
10. existing patient details by pressing Patients from the main screen which will display the Search for Patients screen see Figure 11 Click Search to see a list of all patients see Figure 12 You can enter filters patient ID name office etc to limit the search results CloudPAT Page 16 Operation Manual Itamar Medical Ltd px Home Settings Support Logout itamar Home View Reports Patients Manage Lists Upload Study Search for Patients 1 csv Create New Study ote wwe surance Coverage mapas id al Figure 11 Search for Patients screen TA Home Settings Support Logout itamar Home View Reports Patients Manage Lists Search for Patients J Create New Study Patent 1D Last Name Office First Name Refernng Physician v Date of Birth cal sone JA insurance Coverage List of Patients Patient ID Name Date of Birth Insurance Coverage Study Date TestAliPatientf Levi Rami jr 7 30 1974 5 15 2011 P1D456 7890123456 LN 3456 789012345 N 3156789012345 12 31 1970 6 27 2009 050505 Manual vents TestUpload 7 10 2001 6 27 2009 07261 1 MCh StraightSEPCon 1 17 2012 0000000000 Not initialized Patient details 1 1 1900 1 12 2012 00000000000 PatientFirst Patfirst 8 4 1975 10 14 2010 Figure 12 Search for Patients screen Selecting a Patient ID will display the patient s details screen see Figure 1
11. on unlocked study no report yet This screen presents information about the study patient information the patient name is a link to the patient record and any information modified in the patient record will be reflected in the report until the report 1s locked study date assigned Interpreting Physician Minimum of Desaturation for AHI RDI calculation analysis status report status and errors or warnings returned from the analysis You can indicate to the Interpreting Physician that a script is required for this study and attach files for the Interpreting Physicians review Information can be also found about the assignment history If the office settings allows you can see the Analysis File under Files Most of the fields are not editable The next few sections present what can be done in this screen Note To prevent double work for the Interpreting Physician and the need to open signed reports it is recommended to not assign the study until all patient and study fields are updated correctly and all the relevant files are attached CloudPAT Page 28 Operation Manual Itamar Medical Ltd e ee Report Details Save Back Patent im Office NENNEN Referring Physician T Bracelet Study No Patient 1D D Bracelet ID Study Date 4 9 2010 AS Assigned To a v Insurance Coverage Interpreting Physician Min Desat for AHI RDI Status Analysis Ready Yes Report Ready No Error Warnings inconclusiv
12. provisions of this License Agreement and the instructions provided in the documentation accompanying the Licensed Software and the Licensed Product 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 Any use of the Licensed Software and or Licensed Product other than as set forth in Section 2 1 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 recompile 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 Sleep PAT 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 other
13. 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 materials and workmanship and will perform substantially as it is intended to perform If during such ninety 90 day period the Licensed Software has a defect in materials or workmanship or does not perform substantially as it is intended to perform Itamar shall a attempt to correct or assist you around errors with efforts which Itamar believes suitable to the problem b replace the Licensed Software with a functionally equivalent software or c issue a credit for the purchase price of the Licensed Software with the choice to correct or assist replace or credit being within the sole discretion of Itamar The foregoing correct or assist replacement or credit remedy will be your sole remedy for breach of the warranty set forth in this Section 4 c d Limitation of Warranties The warranties contained in Sections 4 b and 4 c above do not cover damage to the Licensed Products or the Licensed Software caused by accident misuse abuse negligence failure to install in accordance with Itamar s installation instructions failure to operate u
14. user to manage the following lists e Medications enables the User to search for existing medications from global and office level lists and add new ones e Diseases enables the User to search for existing diseases from global and office level lists and add new ones Contact for help with any problems you experience with CloudPAT please contact us by clicking the Contact Us link from any window This link creates an e mail sent to Itamar Medical CloudPAT Support Use the form shown in Figure 9 to send us a message with your problem description The e mail sent to us will include information about the web page the user viewed when he pressed contact us This will help us locate and understand the problem Home Veew Reports Patients Lobby Create New Study Upload Study View Reports Figure 8 Home Lobby screen Page 15 Operation Manual Itamar Medical Ltd ttamar Contact Us f Your Name User Name P Your Email Usergitamar medical com Message Figure 9 Contact Us screen 3 2 Create New Study and manage patients In order to prepare WatchPAT device for a new study select Create New Study from the Home screen see Figure 10 This will create a new patient record and open the patient screen see Figure 13 ENEEN X BN Horne Settings Support Logout ita Mar Se Upload Study Figure 10 Create New Study selection You may browse or edit
15. 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 CloudPAT Page 66 Operation Manual Itamar Medical Ltd 1 2 Licensed Software means the zzzPAT software CloudPAT software and the associated media and accompanying materials provided to you with such 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 License Agreement applies to the Licensed Software 2 GRANT OF LICENSE AND RESTRICTIONS ON USE 2 1 Itamar hereby grants you a non exclusive right to use the Licensed Software solely for its intended use in sleep medicine with the term sleep medicine including Cheyne Stokes respiration as well as research in sleep medicine and Cheyne Stokes respiration 1 with the Licensed Product s and 11 in accordance with the
16. your input and will generate an updated sleep report You may review the new report by clicking on the Analysis File link CloudPAT Note Make sure to upload the correct manual event file The filename will be comprised of ID patient ID _ SD stusy Date amp time _ events analysis user zpt other file will generate an error during the post upload analysis and will not change the analysis file Note In case of a multi night study you can upload a manual event file for each of the nights The system will know to link the files correctly Page 40 Operation Manual Itamar Medical Ltd 8 10 11 View files attached by the office if the office attached file to the study you can view them by clicking on the file name in the attached file by office section Enter interpretation Diagnosis and Recommendations by typing in the information in the relevant sections You may use the Diagnosis and Recommendations templates if you wish to insert an already predefined paragraph in the corresponding section See section 4 3 NPI you can add the NPI to the report If you have more than one NPI select the right NPI number that matches the office details Add attachments like prescription or any other files to the report If you add PDF files they will be added to the report itself Any other files will be available to download in the office To attach files enter a description and select the file to be upload
17. 17 7000 Tall free numbers Pustralia 1800256843 Pustria 800285881 Belgium 80073034 Canada 18662562506 Denmark 50887119 France 800907142 Germany 8001825387 Note that the contact numbers shown above are subject to change Always use the updated numbers CloudPAT Italy 800782332 Nethenands 5000770588 Horway S00 10023 Sweden 20795399 Spain 900940734 UK 2009175110 USA 18002066952 Figure 7 Support screen Page 14 Operation Manual Itamar Medical Ltd 3 Using CloudPAT as a User 3 1 Main Access Screen Home Lobby Here are the main actions that can be selected from this screen see Figure 8 l 2 CloudPAT Create New Study prepares a new patient amp initializes WatchPATTM device for a new sleep study Upload Study uploads sleep study files from WatchPAT device to the CloudPAT web server and subsequent redirection e g interpretation by an Interpreting Physician according to pre determined instructions View Reports enables the User to see which sleep studies have been analyzed and for which diagnosed sleep reports exist The User may optionally elect to receive an email notification that a sleep study has been interpreted and diagnosed Patients enables the User to see which sleep studies have been performed on patients alter the patient s information or generate a follow up sleep study for an existing patient Manage Lists allows the
18. 182201 2 D4 2772012 051422072 051822072 0606 2012 067 0772012 0670772012 0671172012 0601122012 04102207 2 04102207 2 041122072 04192207 2 D4 27 72012 05152207 2 0501392207 2 06062207 2 067 0772012 06072207 2 06122207 2 06122207 2 Revie Unrevi Unselect All Revie Study Selection Start Export Start Archive Start Delete Export to CSW selected aut of 12 total studies 20480 KB out of 245760 KB total estimated MN I DB Connection Local Comment 4 You will now be asked to save this file to your hard drive Itis recommended to choose a folder called CloudPAT that I create prior to this step After selecting the folder to save the exported file click OK 5 Now go to https Wcloudpat precisemd com and login using your username and password 6 Select Upload Study from Home screen 7 Thereafter the following screen will open up Select Switch to Manual Upload CloudPAT Page 52 Operation Manual Itamar Medical Ltd Home Settings Support Logout Home View Reports Patients Manage Lists Sa Upload Study The system is ready for Upload Please check that the WatchPAT device is connected and click on proceed to continue with Upload pm c HR Switch to Manual Upload J Proceed with upload 8 Now you need to find the file that was exported out of zzzPAT by selecting Browse Home Settings Support Logout tamar
19. 24 Upload failed screen Once you upload a study you can choose to add documents to it see section 3 4 2 2 for more details These documents will be available for the Interpreting Physician to review when preparing the report Once the Interpreting Physician locks the report the Office 1s no longer able to attach further documents to the patient record 3 3 2 Manual Mode In the rare event that a manual upload is needed such as when an internet outage occurred and sleep study was uploaded locally using zzzPAT select Switch to Manual Upload in which case the following files patient dat sleep dat and if existing also log dat sleepl dat and sleep2 dat for multi night studies should be CloudPAT Page 26 Operation Manual Itamar Medical Ltd concatenated into a single ZIP file and uploaded this way You may press Browse for the Combined zzp file ZIP file location and press Next see Figure 25 See Appendix A Exporting a study from zzzPAT to CloudPAT Guide for more information about how to export a study from zzzPAT Manual Upload C D Please zip compress the following files from the WatchPAT device Patient dat Sleep dat Log dat if it is exists into a single file then press choose file select the file and press Next to continue Combined zzp file gae Figure 25 Manual Upload The rest of the upload process is the same as for the regular upload selecting Interpreting Physician and o
20. 3 3 2 1 Preparing for a New Study The following steps are involved in preparing for a new study 1 Fill the mandatory Patient ID in the Patient fields as in Figure 13 CloudPAT Page 17 Operation Manual Itamar Medical Ltd Note Patient ID cannot be changed once a device was initiated Note Users that are associated with more than one office will have to choose an office as well a Home EL Support Logout tamar a po to ro aneo Enter Patient Details for Sleep Study ld Save and Initialize Device Initiate Patient Questionnaire Office lofficeA vi Referring Physician drA v Patient iD 123456789 Prefix Mr v L See i m r Furst Name John Middle Initial L Last Name Doe Gender Male v Date of Birth 4 13 1970 I Age 45 Insurance Coverage Medicare v Other Insurance I i More Details Diseases Medications Previous Studies Initializations 2 Questionnaires preciseMD Corporate Contact Us Figure 13 Patient data entry screen 2 Itis recommended you save the patient record at this stage by pressing the save button on the top see Figure 13 You can save the patient record at any stage and return to it later from the Patients screen Note Once the system saves the patient details the system checks the values of the entered fields Erroneous fields and empty mandatory fields will be highlighted in red Correct the e
21. ENSED 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 UNDER SECTION 4 A ABOVE IN NO EVENT SHALL ITAMAR BE LIABLE TO YOU FOR DAMAGES IN EXCESS OF THE PURCHASE PRICE YOU PAID FOR THE LICENSED SOFTWARE THE LICENSED PRODUCT OR THE APPLICABLE THIRD PARTY PRODUCT THE FOREGOING LIMITATION SHALL BE APPLICABLE REGARDLESS OF WHETHER THE ACTION GIVING RISE TO SUCH DAMAGES IS IN TORT CONTRACT STRICT PRODUCTS LIABILITY OR OTHERWISE B IN NO EVENT SHALL ITAMAR BE LIABLE FOR ANY SPECIAL INCIDENTAL INDIRECT OR CONSEQUENTIAL DAMAGES WHATSOEVER ARISING OUT OF OR IN ANY WAY RELATED TO THE USE OF OR INABILITY TO USE THE LICENSED SOFTWARE AND OR THE LICENSED PRODUCT AND OR THE THIRD PARTY PRODUCT OR THE PROVISION OF OR FAILURE TO PROVIDE SUPPORT SERVICES BY ITAMAR EVEN IF ITAMAR HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH CONSEQUENTIAL DAMAGES THE FOREGOING DISCLAIMER OF CONSEQUENTIAL DAMAGES SHALL BE APPLICABLE REGARDLESS OF WHETHER THE ACTION GIVING RISE TO SUCH DAMAGES IS IN TORT CONTRACT STRICT PRODUCTS LIABILITY OR OTHERWISE C IN ORDER TO BE ENTITLED TO INDEMNIFICATION HEREUNDER IN CON
22. First Name Jama Last Mame ID Birth Date 089111880 Age 21 Gender Insurer BMI 18 0 W 121 Ib H 87 Meck Cir EFworth Address Sleep Study Information Study Date 02 25 2010 H A Version Referring Physician Information First Name Last Mame Work Phone Mobile Phone Medical Information Medica History Frequent arausals Madications Thyroid hormone replacement Comments Summary amp Diagnosis Suppine related apnea Recommendations refer io EMT Figure 43 First page of sleep report 14 Notifications you may receive notifications which will be displayed on the screen in the following cases e Ifa script was requested by the office a Study requires a script notification will be displayed on the screen Also a reminder will appear before locking the report e If the office changed one of the following analysis parameters Minimum o Desaturation for AHI RDI calculation Pacemaker Gender Date of Birth a rerun of the analysis 1s required to update the analysis result In case rerun was not initiated by the office a notification that rerun is required will be displayed on the screen and Rerun Analysis button will appear You won t be able to lock the report before rerun the analysis Note Manual events file are based on a specific analysis Verify the manual events you are loading are based on the same parameters as the current study parameters CloudPAT Page 42 Operation Manu
23. G Generate a new STOP BANG Begin Patient STOP BANG Session code Code 1s valid Code from the p atient record Enter the STOP BANG Code and click on Start Session Please bear in mind that a STOP BANG Code is only valid for 20 minutes for 20 minutes Expired code STOP BANG Codes must be used within 20 minutes of generation Please generate a new STOP BANG Code CloudPAT Page 51 Operation Manual Itamar Medical Ltd 6 Appendix A Exporting a study from zzzPAT into CloudPAT Note This guide gives instructions on how to upload a study from ZZZPAT to CloudPAT This process will be utilized when you do not have an internet connection and you loaded the study to ZZZPAT from the WatchPAT device If you do have internet connection it is recommended not to switch between the CloudPAT and the zzzPAT Note Multi night studies uploaded to zzzPAT will be exported night by night if you wish to join them into one study please contact Itamar Medical support for more information 1 Open zzzPAT default Login and Password 111 for both entries 2 Select Export Delete under Tools 3 Highlight the study that you want to export to CloudPAT and select Export for Interpretation Current Selection All Studies JD First Name Select All Last Mame HST12 0n03 HSTLSU12 001 HSTLSU12 0002 HSTwEH 2 0001 H57 12 0001 ER FLUS REDS 34054 blue 4 blue Steve Austin 031822012 0410220172 041042072 044
24. Interpreting Physician and viewing assignment history The user can assign a non assigned study to any of the Interpreting Physicians connected to the office The user can view Assignment History to see how long a study is waiting for an Interpreting Physician in an Interpreting Physician queue Based on that information the user can also change the assignment between the different Interpreting Physicians connected to the office Notification of a new study will be sent to the Interpreting Physician only in the first assignment of the study in all later assignments the study will simply appear in the new Interpreting Physician queue and disappear from the old Interpreting Physician queue Note It is up to the user to verify the old and new Interpreting Physician are notified about the change and to check there will be no surplus charges for the interpretation of this study as 2 Interpreting Physicians have seen it 3 4 2 4 View analysis file Some offices have settings that allow their users view the analysis file pages 2 and 3 of the report before the report is ready This setting is usually given to sleep labs using the CloudPAT where the expertise needed to understand the results are part of the office skill sets Users of such offices can click the analysis file link to open pages 2 and 3 of the report immediately after uploading the study When a multi night study is uploaded all the reports of the night studies results wil
25. Itamar Medical Ltd ttamar CloudPAT Web Software Operation Manual Itamar Medical REFlOM2200000 WatchPAT is a trademark of Itamar Medical Ltd O caution Federal U S law restricts this device to sale by or on the order of a physician Copyright 2011 2015 by Itamar Medical Ltd Software Version 1 0 9 CloudPAT Page 1 Operation Manual Itamar Medical Ltd This manual and the information contained herein are confidential and are the sole property of ai Itamar 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 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 product other than that which adheres strictly to the instructions and safety precautions contained herein and in all supplements hereto and according to the terms of the warranty provided in the License Agreement in Appendix F Screen layouts are subject to change from time to time without notification and without being altered in this Web software operation manual as long as the intent of the content has not been altered significantly 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 pend
26. NECTION WITH AN INFRINGEMENT CLAIM YOU MUST 1 NOTIFY ITAMAR IN WRITING PROMPTLY UPON BECOMING AWARE OF AN INFRINGEMENT CLAIM OR THE POSSIBILITY THEREOF 11 GRANT ITAMAR SOLE CONTROL OF THE SETTLEMENT COMPROMISE NEGOTIATION AND DEFENSE OF ANY SUCH ACTION AND iii PROVIDE ITAMAR WITH ALL INFORMATION RELATED TO THE ACTION THAT IS REASONABLY REQUESTED BY ITAMAR 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 CloudPAT Page 69 Operation Manual Itamar Medical Ltd 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 7 TRANSFERABILITY You may only transfer or assign the rights and obligations hereunder together with the Licensed Software and or the Licensed Product or Third Party Product as a whole without retaining any rights
27. Sleep dat files error appears in the Report Details screen and an email notification is sent to the user Could not The PC does Make sure WatchPAT device is access not recognize connected to the PC via the USB device WatchPAT Select Retry device amar Medical Watch PAT device Could not access device Please check the device connection to the system and click the retry button below Click the exit button to return to the website Attach files to a study or a report CloudPAT Page 50 Operation Manual Itamar Medical Ltd Trying to File attachment is limited to DS ot ey About CloudPAT Support attach a very 20MB per study or report Ita aa a f i A di di 4 large file s Reduce file size medical Maximum request size has been exceeded This would occur if you attempted to upload a file that is greater than 20MB If the file you were attaching was well within the limits or you weren t attempting to attach a file please contact the system administrator Technical Information STOP BANG Session has The Find the completed questionnaire Begin Patient STOP BANG Session been que stionn aire in the p atient record Enter the STOP BANG Code and click on Start Session Please bear in mind that a STOP BANG Code is only valid for 20 minutes completed hasbeen IF needed generate a new Cannot submitted questionnaire from the patient restart record Expired STOP BAN
28. 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 third party product into which a Licensed Product or Licensed Software is incorporated 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 Restrictions on Use as provided in Section 2 do not install use or copy the Licensed Software or use the Licensed Product or the Third Party Product The Licensed Software and the Licensed Products are protected by US patent laws trade secret laws copyright laws and international treaty provisions as well as other intellectual property laws and treaties Therefore you must treat the 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 1 DEFINITIONS 1 1 Licensed Product s means the Watch PAT200 the PAT Probe Integrated Snore amp Body position sensor Tamper proof Patient Identification Bracelet and the corresponding components of any Third Party Product
29. This guide gives instructions on how to download a study from the CloudPAT to zzzPAT for review and manual editing and how to upload the changes back to the CloudPAT This Guide is directed to Interpreting Physicians already familiar with the zzzPAT and it is replacing the zzzPAT operation manual 1 Go to https cloudpat precisemd com and login using your user name and password 2 From the new study screen select the study you want to view in zzzPAT Click on the patient ID to move to the report screen 3 Once you have reviewed the study see section 3 5 above using Preview Report the analysis file and the attachments added by the office you can decide to import the study into your zzzPAT software Click Download to zzzPAT Office Details Rack lawl Preview report Save Save and Lock Report id E Edd LS P ait tai E 4 At the bottom of the webpage you will see a new box open Click on Save and a new box will open then click on Save as 1empiate Recommendations 7 aC HE Do you want to open or save HSTWEI12 0001 5 190412090726raw zzp 8 57 MB from cloudpat precisemd com 5 Save the file to a predefined location on your hard drive We recommend creating a folder called CloudPAT for such file exchange a Save As GO m CloudPAT Interpretation EM Search Interpretation Organize New folder 7 Ur Favorites Documents library EE Ebr Folder gt BE Desktop Interpretation m Downloads 3 Nam
30. age 46 Operation Manual Itamar Medical Ltd Settings Support Logout Studies Templates amp NPIs Templates NPIS Search NPI A CSV NPI NPIs Showing 1 2 Figure 49 Search NPI screen Settings Support Logout i Studies Templates NPIs Templates NPIS NPI List NPIs Save NPI CA1235 Figure 50 Existing NPI screen Settings Support Logout Studies Templates amp NPIs Templates NPIS NPI List NPIs Save NP Figure 51 New NPI screen 4 4 Signature Interpreting Physicians can send Itamar Medical their signature sample as a graphical file In this way the Interpreting Physician s signature will be added to the report automatically The file of the signature should be bmp or jpg file size 384 pixels in width and 186 pixels in height Contact Itamar Medical support for more details CloudPAT Page 47 Operation Manual Itamar Medical Ltd 5 Troubleshooting Note Make sure you are using internet explorer as your browser Trouble Possible Solution Error Message Cause New Study screen Creating a You took too Re run the initialization process a u new study long in little quicker If the problem Initializion Timed out timed out replying to a persists it could be an internet Initializing was cancelled as the process took more than the allotted time message that connectivity problem so contact If this problem persists please contact customer support a
31. agnosis or Recommendations sections For example you may define a diagnosis template for Severe Sleep Apnea and a different one for Mild Sleep Apnea You may have a number of predefined templates for Clinical diagnoses and for Recommendations which can be used with a click of a button in order to facilitate the Reviewing process Using a template will fill the relevant section diagnosis or recommendation in the report After choosing a template you may edit the text Selecting the Templates tab will open up the Template Search screen see Figure 46Error Reference source not found CloudPAT Page 44 Operation Manual Itamar Medical Ltd Settings Support Logout Studies Templates amp NPIs Templates NPis Template search H 2 Text supine related apnea apneal Diagnosis ENT Recommendation refer to ENT Showing 1 2 of 2 Figure 46 Search a template screen Note Click on the CSV icon if you want to obtain an Excel file containing a tabular presentation of the search results Clicking on the New button will open up a new template for editing see Figure 47Error Reference source not found Settings Support Logout itamar Studies Templates amp NPIs tao tati NPIS Enter details about the Template Name Type Diagnosis Text Figure 47 New Template screen You need to fill all three fields Name Type and Text in order to define the new template Clickin
32. al Itamar Medical Ltd 4 2 2 Viewing a Completed Study After selecting a Patient ID while on the Completed studies tab you will be brought to the following screen see Figure 44Error Reference source not found from which you can view the old sleep study Here are the main actions that can be selected from this screen 1 Analysis File link you can Click on the Analysis File link in order to see the two page report that was produced automatically by CloudPAT without your interpretation 2 View report you can click on the View report button in order to see the full final report with your interpretation included Templates amp NPis PATIENT MEN Figure 44 View a completed study 4 3 Manage Templates 8 NPls This section explains how to manage the lists of templates and NPIs each Interpreting Physician has Selecting the Templates amp NPIs tab will open up a search screen in which you can choose between templates and NPIs see Figure 45 CloudPAT Page 43 Operation Manual Itamar Medical Ltd tamar Ga Studies Templates amp NPIs Templates NPIS Template search CSV searcn Ji New M e Name Ooo M Templates Name Type Text apneal Diagnosis supine related apnea ENT Recommendation refer to ENT Showing 1 2 of 2 Figure 45 Templates amp NPIs screen 4 3 1 Templates Templates are predefined paragraphs ready for use while reviewing a study and entering the Clinical Di
33. amar Medical Ltd Note On first use configure the zzzPAT to allow interpretation for CloudPAT studies go to Setup gt General Settings General Options then check the Enable Packed Studies Import checkbox and go to Setup gt User Settings Options then check the Enable Manual Scoring and the Enable Export Manual Events checkboxes Once the study files are downloaded you can use the Import Packed study zzzPAT s function in order to open the study view the signals and edit the Respiratory events or sleep stages if needed see zzzPAT s OM Note You should make sure that the zzzPAT has the same AHI calculation method 396 or 496 setting as the study e Inthe Analysis File look for the pRDI pAHI are calculated using oxi desaturations gt number Inthe zzzPAT look at Setup General Settings 2 Analysis Statistics Parameters 6 Errors Warnings in case of errors or warnings returned from the analysis a message will appear in the Errors Warnings box 7 Load Manual Events and Reanalyze in case you used the Download to ZzzPAT function and manually edited the Respiratory events or sleep stages you will be required to save the new manual events file in zzzPAT press File gt Export Manual Events and then point to this file when clicking browse on the Manual Events Files field see Figure 41 This action will re analyze the study using
34. core as usual with zzzPAT Page 63 PATIENT PAT Logi zzzi Login ie Login Type C Active Directory Service ADSI AC zzzPAT Database Move Files to New Location Export General Settings Import General Settings Import Packed studies Operation Manual Itamar Medical Ltd Interpreting Physician Physician review of raw sleep study data part 2 E md aE p pana ee Rea Qe edit and e Add and or Delete Events per your training Core Su en score the e The changes now need to be saved on e gt sleep study your local disk USER e Select File Save Event Select Export Manual Events changes on A new box will open local disk e Save the changes to your local CloudPAT Folder e Select OK Upload e he manually edited changes now need Event to be uploaded back to CloudPAT changes to Select Browse CloudPAT e Find the saved file highlight it select Open e Select Save from the CloudPAT toolbar PATIENT e Your manually edited study is now saved and Uem AE CloudPAT on CloudPAT ready for sas using a eo your customizable template system Load Manual Events and Reanalyze e Preview the new report e Enter Diagnosis and Recommendations e Open files attached by the office if any by clicking on the file link e Add prescriptions or additional information as PDF attachments Prepare o Goto the Attached File
35. ctice responsible to dispensing the tests Office can include one or more referring physicians as well as technicians and administrative staff o Referring Physician the primary physician or dentist prescribing the sleep test o User typically a Provider such as a technician or a nurse but might also be a physician This 1s the most common type of user using CloudPAT functions such as Creating a new study Uploading a study Viewing reports and Managing Patient Information see Section 3 o Interpreting Physician a physician typically Board certified performing the sleep study analysis interpretation diagnosis and recommendations This is another type of user using CloudPAT functions Reviewing and interpreting studies and Managing templates for diagnosis and recommendations see Section 3 5 o Patient the person who undergoes the sleep study 1 6 Minimum requirements An internet connection using a PC workstation with Microsoft Win7 and above running at a minimum upload speed of 1 Mbps and Internet Explorer version 7 0 or higher is required 2 Setting CloudPAT Access 2 1 Obtaining an account Usage of CloudPAT is intended for WatchPAT customers only using Watch PAT200 200U devices A secure and individual login account must be assigned by Itamar administrator To obtain a Username and Password contact Itamar Medical or send an email to info 1tamar medical com After a vetting process you will get an email inv
36. d 17 9 2 2 Pust Time InitializatiOll AAA ad tese tc uiae Sd than ad desides 23 3 2 34 Jnitialization Process Protection Lais e rn e a Wnty Shemans 23 2 94 Uploadin a a MO ini 24 Sod Normal Upload Mode iii ad tetnaoentss 24 Seve Manual MOG o irte ab E 26 3 4 Managing studies and Viewing ReportS oooocccccccccncnononcnncnnnnnnnnnnninnnnnss 21 Seki Scarch studies and TOPOS s eC o e DO b de 27 2052 ld VcmiandSettie lt ox esveitentdhv ida dina 28 3 4 2 1 Understanding the Study scr ct ia 28 3A 2 2 Atfachine testo asia 29 3 4 2 3 Changing Interpreting Physician and viewing assignment history 30 22291 View anahisi EMO cobi AT 30 IRs iReQdUGSLIOE ads iP accio ala 31 3 4 2 6 Changes of Study ParameterS oocccccccccooooonncnnnnnnnnonononnnnnnnnnnnnnnnnnnnnnnss 31 Sos VIEWS TENOR Si o R 31 o PP adie E N LIU cde 32 a Medications a dos 33 A WDISCASCS quide etcetera peas eis uM tdt eae etna 35 4 Using CloudPAT as an Interpreting Physician ooooonncnnnnncnnnnnnnonnnnnnnnnnnnnnnos 37 Ad MamnActess Soe ds 37 SEMESTER 37 Aade A 38 4 222 VICWINS a Completed Study acentos ec nd 43 Ae Mamae Templates INPS atril ita 43 d Temples eaa a teo desit Genel Se nmin den auo desia c edD D LEE I etudes 44 NEMPE I E 46 dads REM 47 CloudPAT Page 3 Operation Manual Itamar Medical Ltd 3 PROUBDICSNOOUING oerte tai D kei feta Sucht eni D ide calce 48 6 Appendix A Exporting a study
37. e Date m E Recent Places HSTWEIL2 0001 5 190412090726raw zzp 6 26 20 Libraries E Documents ca Export HST al Music E Pictures BE Videos Save as type eee File s Hide Folders Save p Cancel CloudPAT Page 55 Operation Manual Itamar Medical Ltd 6 To review the raw data open zzzPAT software and login default Login and Password 111 for both entries zzzPAT Login Login Type t Active Directory Service ADSI le 222PAT Database Login 111 Password ES BB Connection Local 7 Select Import Packed studies under Tools File Edit View Events Paging Setup Analyze Report Tools Help Ee La ER ES Export Delete m d AAA M Import Backup Restore Move Files to New Location Export General Settings Import General Settings User Administration 8 In the dialog box that opens select the file you have just saved in the CloudPAT and click Open 9 A new box will now open and the imported study will now be loaded and analyzed EB zzzPAT W cw um Qi CloudPAT Page 56 Operation Manual bia zzz Export Manual Events Sa02 Actigr WP Body dB PulseR ate BPM E E E E Desaturatior mE Des Desaturation Ml E Des Desaturation IN EE Light gm Light Sle Light SI Light Light c Light Light Sleep REM Bl Deep Sleep REM Deep Sleep RE REM Deep Slee D
38. e REM Files Analysis File anatysis9S pdf Request Script Interpreting Physician History Assignment Date Interpreting Physician No records Attached Files up to 20MB in total v X Description File Upicaded On Uploaded By Browse Files attached by Interpreting Physician No Files attached Figure 27 Study screen 3 4 2 2 Attaching files to a study Once a study is uploaded and as long as the report 1s not locked the user can choose to add documents to it These documents will be available for the Interpreting Physician review when preparing the report To attach a file enter a description and select the file to be uploaded using the Browse button To add additional files click the icon at the top of the list and a new line will be added to the table Note The maximal size of all attached files 1s limited to 20MB The user can also remove attached files by marking them for deletion see Figure 28 CloudPAT Page 29 Operation Manual Itamar Medical Ltd Attached Files up to 20MB in total Q x Description File Uploaded On Uploaded By E ECC ECG jpg 4 13 2014 5 55 17 AM litman Attached Files up to 20MB in total Q Description File Uploaded On Uploaded By tman p 1 Figure 28 Deleting attached files Save the study by pressing the Save button on the top of the screen to complete uploading the attached file and to remove deleted files 3 4 2 3 Changing
39. e to Run USB port e You will be prompted to select an Interpreting Physician after the study has uploaded Depending on your connection speed the PIA RCM RR o device type and the number of night in a Itamar mmen Upload multi night study upload time will vary FA progress between two 2 and fifteen 15 minutes If E an error is reported you will need to try again armar Medical Watch PAT device Internet Connection required Lamar CloudPAT Page 60 Operation Manual Itamar Medical Ltd Aton Upload Complete Study uploaded Select successfully Now you can select the Interpreting nterpreting Physician that will interpret the Physician study can be done later on form the study page Select Next Upload Failed try again or call Support Select View Reports Select the Study for which you want to attach files by clicking on the Patient ID link Go to the Attached Files section at OPTIONAL the bottom of the Report Details Attach Files Screen and Browse to the file and up to 20MB add Description and update Add additional files by clicking on the study details sign on the right Select the box under the x to delete a file Update study parameters if needed and Assign to Interpreting Physician if needed Select Save to save your changes Manual Upload from zzzPAT to CloudPAT Rarely needed e g if an internet outage occurred and sleep study was saved locally on zzzPAT
40. ed using the Browse button To add additional files click the icon at the top of the list a new line will be added to the table The user can also remove attached files by marking them for deletion see Figure 42 Attached Files up to 20MB in total Y x Description File Uploaded On Uploaded By prescription pdf Browse 4 16 2014 12 38 51 AM Efrat test letter to patient pdf LLL LLL e Figure 42 Attach files to a report Save the study by pressing the save button on the top of the screen to complete uploading the file and to remove deleted files Note The maximal size of all attached file is limited to 20M B 17 13 Save saves your input without locking the report Save and Lock Report finally when you are satisfied with your interpretation select the Save and Lock Report button At this point the study report will be automatically digitally signed with your name tagged as completed and be available for the Physician s review Note Once a report is Locked no more changes can be added Use the Save button if you are not sure if you are done with this study If a report 1s accidently locked contact Itamar Medical in order to unlock it CloudPAT Page 41 Operation Manual Itamar Medical Ltd E ee A 2a i Wc HL i TIA pbc j he aly n dia Me i t y y pto Alaki A L ip n 2 JL d T Sleep Study Report Office A THeader1 CHRoOSA Header Patient Information
41. eep Sleep Stages Pos Position Snore Itamar Medical Ltd 10 The study is now available to be reviewed and manually edited by the interpreting physician Note When importing multi night study into zzzPAT each night will create a different zzzPAT study Each of the night should be Once the interpretation process is done reviewed and edited separately If changes were made in the study the study will need to be uploaded to CloudPAT by following the steps below 11 Save the study in the zzzPAT 12 Go to File and select Export Manual Events PAT Baker Trevor HSTWEI12 0001 Tested on 04 18 2012 Analysis created on 4 19 2012 9 07 29 AM by Super User Reviewed 9 o e x dit View Events Paging Setup Analyze Report Tools Help New Study Details Ctrl N XB ES AI Open Study Ctrl O x a RM EE pa an Save Study Resulis CtrleS A A SUMI ian di IE S E EA EIRE T DIRE i E AT Close Study Ctrl F4 Load Study and Analyze Ctrl L A Resp E Fl ER FERRER Resp E Resp IF F Resp RH FRe ReR Res Resp Event IB FF Hanh eli Resp Res F D Excl plead Event Excludec Excluded R Exclude Exclud T 1 Print Ctrl P Export Data 7 Export Exit aph 2upine El kel Deep Dee Lial FT Sleen E Light Slee Light Deep REM S 00 38 08 De Desat Desat ma cD Desatu Desat Desaturation fil gt m MS E B Deep Sle Light SI Light E Lig
42. erning 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 CloudPAT Page 70 Operation Manual Itamar Medical Ltd writing signed by Itamar and you This License Agreement may not be amended other than by a written agreement specifically intended 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 P O Box 3579 Caesarea Ind Park 3088900 Israel Facsimile 972 4 627 5598 or visit Itamar s web site at www itamar medical com CloudPAT Page 71 Operation Manual Itamar Medical Ltd 10 Appendix E Regulatory Representative Itamar Medical s authorized regulatory representative 1s 5 Beaumont Gate Shenley Hill Radlett Hertfordshire WD7 7AR England Tel 44 20 8123 8056 Tel Fax 44 1923859810 CloudPAT Page 72 Operation Manual
43. from zzzPAT into CloudPAT 22 7 Appendix B Interpretation and editing of events by the Interpreting Physician Cc 25 8 Appendix C CloudPAT Assistant cheat sheets ccccoccnnnnnnnoconaaoaccccncnnnnnnss 50 9 gt Appendix D License A Ore emic it 2559 tesa ce roto one bere dele ens boton be bunt 66 10 Appendix E Regulatory Representative esses 72 Table of Figures Eroure Simi Sere 10 UI Sel e A O 10 Fasure 2 Chango Pass word Screen it UU Rue 12 Fisute 4 Reset Password SCEeells ierices Relato eue Dor totom enu e uU a iM tr ORO uI ue 12 Figure 4 Functions available from all screens ooooooooonnnnncnnnnccnnnnnnnnnnnononononanononos 13 Fasure Prone Se A A tae eee CTS MM LEURS 14 Piste G Support SCECOPL oue eeR it aaa 14 Ersure 1 Home LODDY SCC Cis ecce cated taro zane seti EE esae dated 15 Fiure o Contact US Oreiro 16 Figure 9 Create New Study selecHhon Leere iii 16 Figure I0 Scarch tor Patients S Che en sins dia 17 Figure LT Search for Patents SCECeT o noo stars llei 17 Proure 12 Parent dati entry SECO iii 18 Figure 13 More Detail screen for patient data optional oooooonncnnnnnnnnnononinnnnnss 21 Figure 14 Initialize Device SCLeen siii 22 Figure 15 Message to download the PC resident program sss 23 Figure 16 Protection from accidentally overwriting previou
44. g on an existing template name see Figure 46Error Reference source not found will open up the Template screen for editing see Figure 48Error Reference source not found CloudPAT Page 45 Operation Manual Itamar Medical Ltd Here are the main actions that can be selected from this screen 1 Save amp New Saves the template and creates a duplicate template 2 Delete Deletes the template 3 List Returns to the list of templates 4 Save Saves the template Settings Support Logout ita m c n TU EXT Studies Templates NPls Templates NPIS Enter details about the Template Save amp New Name ENT Type Recommendation v Text refer to ENT for consultation Figure 48 Existing Template screen 4 3 2 NPIS You can manage a list of NPI to later be used in the report Under Templates amp NPIs choose NPIs Click on Search to see the list of all NPIs currently in the system see Figure 49 You can also enter text in the NPI field to limit the search results Clicking on an existing NPI will display the NPI s details screen in which you can edit the NPI number and save the changes see Figure 50 Clicking on the New button can be used to add a new NPI to the list Make sure you save your changes see Figure 51 Note Click on the CSV icon if you want to obtain an Excel file containing a tabular presentation of the search results CloudPAT P
45. ghts e Select Save amp Initialize Device Patient Detail Entry Initialization Select Proceed with initialization complete e 1st time usage a small PC resident program will be downloaded Select Run Success CloudPAT Page 59 Operation Manual Itamar Medical Ltd e 7 ter ome Select e Select the Interpreting Physician or Interpreting leave empty at this point Physician e Select Save c e a Y gt o cC c D pum o pon o ey iS e Reinsert the WatchPAT device into its Prepare the cradle device e Complete a device test e Instruct the patient about the use of the device Upload Sleep Study from WatchPAT to CloudPAT I 9 e met Do you have 1 Computer running Win7 or higher with Before you udin 9 d Problems or Questions start 2 Internet Explorer 7 0 or higher PRECE POA Call 1 888 748 2627 3 Username amp Password 4 Minimum upload speed of 1 Mbps itamar Enter Log in to www cloudpat precisemd com CloudPAT e Enter your Username amp Password via the Web e Select Sign In Logging in Upload a Select Upload Study Sleep Sur Slide WatchPAT device out of its WatchPAT cradle to reveal the USB connection device to Connect WatchPAT device to a USB CloudPAT port Select Proceed with upload Connect e 1 time usage a small PC resident WatchPAT program will be downloaded Select devic
46. gn In screen see Figure 1 and you will get the following sequence where you press Continue after each stage Follow the instructions on each screen see Figure 4 In the event you forget your username first try this first name last name and if it doesn t work contact customer support 1 e john smith Forgot Password we Forgot Password Continue I An AA gt A A o M A Please answer the following question If your answer matches our answer on file we will send you instructions for resetting your password to the email account on file mothers maiden name Forgot Password An email has been sent to the address on file Please check your email and follow the instructions in it If you have any problems please contact customer support at 888 XXX XXXX Figure 4 Reset Password screens CloudPAT Page 12 Operation Manual Itamar Medical Ltd 2 6 Profile Settings amp Support Users may set their preferences by selecting the Settings option from the top of any screen at any time see Figure 5 Last name and Email address are mandatory fields see Figure 6 The secret question you have chosen and your answer will be displayed here as well You may change the secret question at any time if you want The Notificat
47. he PC resident program 3 2 3 Initialization Process Protection Overwrite protection If a previous study was found on the WatchPAT device that was not uploaded to CloudPAT it will not permit you to overwrite that data but will prompt by saying Previous study found see Figure 17 and that you should upload the study before proceeding This behavior prevents you from accidental overwriting a study that was not uploaded ltamar Medical Watch PAT device itamar medical Previous study found There is a previous study on the device please use the upload study module to export device data before proceeding to initialize device Figure 17 Protection from accidentally overwriting previous sleep study CloudPAT Page 23 Operation Manual Itamar Medical Ltd 3 3 Uploading a Study This section covers uploading a study from the device and manual upload of study for zzzPAT users 3 3 1 Normal upload Mode When a patient returns WatchPAT device after a night study simply connect WatchPAT s mini USB port to any USB port on the PC by using WatchPAT s communication cable and select Upload Study from the Home Screen see Figure 18 Home Settings Support itamar eme Home Veew Reports Patients Create New Seu I Upboad Gtutby iD Lobby Create New Study Figure 18 Upload Study Selection Proceed by selecting the Proceed with upload button see Figure 19 Upload Study
48. here password Secret Question What is your mothers maiden name v ES Figure 2 Set Password screen For identification purposes you will be prompted to fill in an answer to a secret question CloudPAT Page 10 Operation Manual Itamar Medical Ltd You must select a secret question and provide an answer to it This answer will be used for authentication in case you forget your password and need to reset it in such case a new temporary password will be sent to your email address Note All asterisk tagged fields are mandatory and should be filled see Figure 2 CloudPAT Page 11 Operation Manual Itamar Medical Ltd 2 4 Changing password When an office is defined there s an option to determine the period of time in days that the password is valid before it expires After that the system will require the user to change his password by the same rules mentioned in section 2 3 see Figure 3 ita m c f vel old mit ET Set Password O Help Print CC Email Save Please reset your password before you continue Organization Itamar Medical Name EE New Password i _ Retype New Password Secret Question What is your mothers maiden name v Tr Answer iz E Email MIS itamar medical com Figure 3 Change Password Screen 2 5 Resetting Password In the event you forget your password simply click on Forgot your password link on Si
49. ht Sleep Light Sle Ligh Light Sh Light Sleep MI Wal Light Sleep REM Wake J Wake i Wake i Wake Wa Wake REM Pi adi E ova DB Connection Local ABS Begin 20 38 08 00 09 51 58 AM 13 Select a file location again we recommend using a predefine location Press ok 14 The manually edited changes now need to be uploaded to CloudPAT Go to https Wcloudpat precisemd com and login using your user name and password Locate the study you were working on and enter the report screen like before 15 Click the Choose File button near the manual events files box CloudPAT Manual Events Files x File Goose rio fi e ho Please note that any addition deletion or modification of entries will result in rerunning analysis on save Page 57 Operation Manual Itamar Medical Ltd 16 Find the saved file The file name will consist from the patient id and the study date amp time in the following structure ID patient ID SD study Date amp time _events_analysis_user zpt Select the file and click Open 17 Save the report PATIENT Ei 7 The manually edited study is now saved to CloudPAT Record saved 6 26 2012 8 11 56 AM 18 You can check that the analysis file was updated with your manual events 19 Fill the Diagnosis and Recommendation fields and add attachments as needed 20 Save and Lock Report to complete the process and alert the provider that the study is complete
50. iewed and finalized the report the user who uploaded the study will receive an email notification that your patient sleep study report is available Alternatively you may poll the system by pressing View Reports from the main screen which will display the newest studies as well as a list of previously viewed sleep study reports After selecting a Patient ID from the list of reports you will be brought to the report screen see Figure 30 from which you can review the signed sleep study report and the attached files CloudPAT Page 31 Operation Manual Itamar Medical Ltd Home Voew Reports Patients Manage Lists ME 2 m v ied dy Report Details Report is locked Modifications ere ot allowed af this ome Status Files Specealest History Assignmense Date Speceualist Anached Files J Mo Files attached Files attached by specealest Figure 30 Report Details for reviewing sleep study reports Simply click on the Result File link for a details report complete with comments and diagnosis from the Interpreting Physician PDF file attachments added by the Interpreting Physician will be appended at the end of the report Other attachments non PDF will only be viewable by downloading them clicking on the link to the file In case of multi night study the analysis of each night will appear one after another in the report followed by a summery page at the end Note Contact Itamar Medical support for other f
51. ile type options of report availability 3 5 Manage lists This section explains how to manage the office s lists of medications and diseases The user can add items to the list and edit or delete them Selecting the Manage Lists tab will open up a search screen in which the user can choose between medications and diseases see Figure 31 CloudPAT Page 32 Operation Manual Itamar Medical Ltd Notice that each list contains both the office list and a global list for the whole system Items in the global list cannot be changed Home Settings Support Logout itamar vidi didi Home View Reports Patients Manage Lists Medications Diseases Search for Medications defined for my Office s 1 CSV Search l New Name Office v Include global list Y Figure 31 Manage Lists screen 3 5 1 Medications Under Manage Lists choose Medications Click on the Search button to see the list of all medications see Figure 32 You can enter filters medication name office include items from the global list to limit the search results Clicking on an existing medication name will display the medication s details screen in which you can delete or edit details and save the changes see Figure 33 Note Click on the CSV icon if you want to obtain an Excel file containing a tabular presentation of the search results CloudPAT Page 33 Operation Manual Itamar Medical Ltd Home Sett
52. ing US patent applications and corresponding patents and or applications filed in other countries Itamar Medical Ltd 9 Halamish St P O Box 3579 Caesarea Ind Park 3088900 Israel Tel 972 4 617 7000 Fax 4 972 4 6277 5598 www itamar medical com supportOitamar medical com LAN OLA Con E ese lt CE S Intertek Intertek 207233 ISO 9001 2008 and EN ISO 13485 2012 certified CloudPAT Page 2 Operation Manual Itamar Medical Ltd Table of Contents apace E dt ak R MENU M ELM Md EU MM M EE 1 l utroducttomto CIOUGP AT sisi 7 ll Intended Use of WatchPATtM device ia 7 EZ UZZPAT S W Deion stati v a 7 1 54 ClougPAW S W Denimo cana 7 Fas DA at conn rede 8 Ls ocn c 9 LO MATA rcge elit S25 0 5 0 bc enero E 9 2 pete C loud P AT ACC siii xe Her Obeper t u e Rab gd Ore ber PUn pez eene iae 9 2 4 ODANDE am accord oso pepe Dat 9 2 2 Accessing C IOUGP AT aia pet ed aea cibos e tul od adus 10 2 9 Semne initial PassWord ed epe neuen 10 224 CMAN CINE PASS OL eeu ob tea Abc NM utbs n 12 2 Resettine PASS WON Loon ad Geo deam cited die oo dram dto irt 12 20 Pronk setine s e gt UPPO n T t P aba idea ua 13 Se Usine CloudPAT asd Us eras cda 15 3 1 Main Access Screen Home Lobby oocccccccccccccccnnnnnonononanonnnncnnncnnnnnos 15 3 2 Create New Study and manage patients ooooonnccncnnccnonononnnnnnnnnnononnnannnnnss 16 Sd Preparing Ora New S
53. ings Support Logout tamar Home View Reports Patients Manage Lists Upload Study Medications Diseases Search for Medications defined for my Office s i csv w Medication List Name Office Advil All Offices Anti acid All Offices Anti arrhythmia All Offices Anticonvulsants All Offices Anti depressants All Offices Aspirin All Offices Diuretics All Offices Hypoglycemic All Offices Inhaled steroids All Offices Insulin All Offices None All Offices Oxygen therapy All Offices Statins All Offices Ihyroid hormone replacement All Offices Anti coagulants All Offices Metformin All Offices Figure 32 Search for medication screen Home Settings Support Logout m Medications Diseases Medication Details offe Name CPAP Figure 33 Medication Details screen On New tab you can add a new medication to the list If you are connected as user to more than one office you will be asked to select the office for which the medication will be added Do not forget to click save after you add or change an item see Figure 34 CloudPAT Page 34 Operation Manual Itamar Medical Ltd Home Settings Support Logout itamar Home View Reports Patients Manage Lists Medications Diseases Medication Details ofc Figure 34 New Medication screen 3 5 2 Diseases Under Manage Lists choose Diseases Click on the Search butt
54. ions check box is for receiving emails notification e User will get notification when a report for a study that has been uploaded is ready e Interpreting Physician will get notification when there is a new study awaiting interpretation For administration support and help with any problems you experience with CloudPAT please contact us by clicking the Contact Us link from any window This link creates an e mail sent to Itamar Medical CloudPAT Support Use the form shown in Figure 9 to send us a message with your problem description Please contact customer support by pressing Support from any screen if any difficulties arise The Support screen contains the up to date phone numbers see Figure 7 aaa ccc Home Settings Support Logout ta Mm a olii sai HM s medical Figure 5 Functions available from all screens CloudPAT Page 13 Operation Manual Itamar Medical Ltd Profile Settings Lagin ID Prefix First Hame Middle Initial Last Mame Suffix Secret Question Answer Jab Title Address City State Zip Code Country Work Phone Extension Mobile Phone Email Notifications 0S1 b L What is your first pets name peny bdesn itamar medical cam E N Figure 6 Profile Settings For assistance please call one of the numbers listed below When instructed by the support agent please click this link Click Here UWS and Canada Tel 1 888 743 2627 Intemational Tel 372 46
55. itation containing your assigned Username followed by a 2 email with the initial password Note Be sure to change the initial password upon sign in Be sure to select Secret Question and provide an answer so you will be able to generate a new password in case you will forget your password CloudPAT Page 9 Operation Manual Itamar Medical Ltd 2 2 Accessing CloudPAT All subsequent access to CloudPAT will be via the Sign in icon located on the home screen of www Itamar Medical com or directly at https cloudpat precisemd com Access to CloudPAT starts with the Sign In screen where Username and Password are entered see Figure 1 ita aa af el le mas Mya Sign in to CloudPAT Username Password Forgot your password STOP BANC Questionnaire of the po 5 Agreement Ur USING THE W Figure 1 Sign In screen 2 3 Setting Initial Password Upon initial account setup you will be prompted to enter an initial temporary password Upon first time signing in CloudPAT you will be prompted to pick a new password see Figure 2 The minimum password length 1s eight characters that must contain characters from three of the following four categories English uppercase characters A through Z English lowercase characters a through z digits 0 through 9 Non alphabetic characters for example 96 Set Password Please reset your password before you continue Organization Itamar Medical Name Yourname
56. k 39 Attach Tes OAT PO stus chante iba Mte Loa aah ia eta abe atts 4 Lirst pase OL Sleep FeO Ei stes eet tidie edt tato adan 42 VIEW a completed SDUGV esed e acude 43 Templates NPIS SCS 44 Seatcira template Srs debida 44 New Template SCree AA 45 Existing Template Stre o e 46 S ENPI O ED E DEAS 47 IE dsuno NEPI CTO Ma maa meena e aer ld EE eU 47 IN WIN ETS Gee ise oec mb ede EU ML I eee ee 47 Page 5 Operation Manual Itamar Medical Ltd Edition Table Edition Date Description Chapter 0 August 2011 November 2012 2 March 2014 Update software version All All Updating Itamar Medical address Updating ISO symbols Updating authorized regulatory representative address April 2015 Update software version July 2015 Update CloudPAT S W Definition CloudPAT Page 6 Operation Manual Itamar Medical Ltd 1 Introduction to CloudPAT 1 1 Intended Use of WatchPAT device WatchPAT device is a non invasive home care device for use with patients suspected to have sleep related breathing disorders The WatchPAT device is a diagnostic aid for the detection of sleep related breathing disorders sleep staging Rapid Eye Movement REM Sleep Light Sleep Deep Sleep and Wake snoring level and body position The device generates a peripheral arterial tonometry PAT Respiratory Disturbance Index PRDI Apnea Hypopnea index PAHI PAT sleep staging identification PSTAGES and optional snoring level
57. l appear in one analysis file one after another with a summery page in the end CloudPAT Page 30 Operation Manual Itamar Medical Ltd 3 4 2 5 Request for a script In case Interpreting Physician should add a script to the report check the Request Script box Save the study by pressing the Save button on top of the screen to complete sending the request to the Interpreting Physician The Interpreting Physician will get a reminder to add a script upon locking the report 3 4 2 6 Changes of Study Parameters The user can change patient information and some study parameters as long as the report is not close Some of the parameters will require running the analysis again e AHI index according to 3 or 4 desaturations e Pacemaker this option is shown only if the feature is enabled e Gender e Date of Birth After making changes to these parameters whether in the patient screen or in the study screen the user should rerun the analysis to get the new correct results see Figure 29 A reminder about the need to rerun the analysis will appear on the top of the page together with an option to rerun the analysis Once reanalyze a notification will be sent to the Interpreting Physician Report Details Figure 29 Rerun Analysis Message 3 4 3 Viewing reports After a patient sleep study has been sent to your Interpreting Physician for review and interpretation and the Interpreting Physician has rev
58. medical com Message Figure 39 Contact Us screen 4 2 Studies After a patient sleep study has been sent for interpretation you will receive an email notification that a sleep study 1s awaiting interpretation Alternatively you may poll this by pressing on the New tab from the main screen which will display the new studies screen see Figure 40 which includes all unlocked studies waiting for you CloudPAT Page 37 Operation Manual Itamar Medical Ltd You may also select the Completed tab for viewing completed signed sleep study reports You have the option to review subsets of your studies by selecting a particular Office Patient name etc see Figure 40 Note Click on the CSV icon if you want to obtain an Excel file containing a tabular presentation of the search results Settings Support Logout itamar Studies Templates NPIs Completed Results search Patient 1D l o Office Patient Last Name Patient First Name l Results A 9A08 7 23Feb15 04 18 33FD 50 MusbaOffice 2 18 2015 4 12 2015 30 Showing 1 1 of 1 Figure 40 Study selection screen 4 2 1 Reviewing a Study When you are in New studies tab selecting a study you want to review clicking on the Patient ID link will display the following screen see Figure 41 from which you can review the new sleep study CloudPAT Page 38 Operation Manual Itamar Medical Ltd PATIENT Please note
59. nder 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 warranty does not cover damage which may occur in shipment This warranty does not apply to Licensed Products and or Licensed Software not purchased new This warranty does not apply to any Licensed Product or any individual parts of a Licensed Product which have been repaired or altered by anyone other than Itamar or a person or entity authorized by Itamar to repair Licensed Products While every reasonable effort has been made to ensure that you will receive Licensed Software that you can use tamar does not warrant that the functions of the Licensed Software will meet your requirements or that the operation of the Licensed Software will be uninterrupted or error free Itamar is not responsible for problems caused by changes in the operating characteristics of the hardware or operating system software CloudPAT Page 68 Operation Manual Itamar Medical Ltd 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 LIC
60. nights recording with the same WP200 device select the number of nights needed There are two options for Multi Nights study o Two nights when no charging is needed between the nights maximum length of study 1s approximately 8 hours o Three nights when charging is necessary between the nights maximum length of study is approximately 10 hours Note Changing the number of night in a multiple night study might require longer initiation of the device Note The Enable Tamper Proof Testing and Enable Multiple Nights options are available only when the WP200 Page 19 Operation Manual Itamar Medical Ltd internal S W is version 2 2182 and higher 5 Diseases and or Medications can be added in the respective drop down lists or as free text Note Free text entered to lists will automatically be added to the office s list You can add update and remove items from the office lists see section 3 5 for more details 6 You will be able to let the patient fill a STOP BANG questionnaire click on Initiate Patient Questionnaire in Patient Details page to receive an individual code which will be valid for 20 minutes only Note Once the patient starts the questionnaire he she has 20 minutes to complete it If they don t complete it in that time a new code will need to be generated from within the Patient Details screen Go to https cloudpat precisemd com SB aspx or click the STOP BANG link sho
61. nward 3 4 Managing studies and Viewing Reports 3 4 1 Searching studies and reports Clicking the View Reports gets the user to a search screen that enables viewing all or a subset of the studies and reports available to the current user see Figure 26 Filtering by patient name and ID Office Referring Physician study and load dates and the study report status study sent to Interpreting Physician report ready report viewed are available The patient ID in the search result is a link to the study record y Home Settings Suppor Logout itamar Vids Home View Reports Patients Manage Lists Search for Reports CSV Patient ID Patient Last Narne Office vl Panent First Name Referring Physician vi Study Date Load Date 10 Sent to Interpreting Yes No Either r Physician Report Ready Yes No e Esther Report Viewed Yes No e Either List of Reports Patient ID Name Study Date Load Date Sent to Interpreting Physician Report Ready Report Viewed WP Study WP Study WP Study 8 29 2009 8 4 2011 Yes Yes Yes Figure 26 Viewing Sleep Study Reports Search results can be exported to a CSV format CloudPAT Page 27 Operation Manual Itamar Medical Ltd 3 4 2 Study management Once a study is uploaded and until the Interpreting Physician locks the report there are several tasks that a user can do 3 4 2 1 Understanding the Study screen Figure 27 shows the study screen
62. ommended to not assign the study until all patient and study fields are updated correctly Note If the office defined Interpreting Physician as Medicare Physician Interpreting it will be indicated next to his name while selecting Interpreting Physician from the list itamar G Home View Reports Patients Manage Lists Initialize Device The Patient s information is now ready for initialization Please check that the WatchPAT device is connected and click on proceed to continue with Initialization Figure 15 Initialize Device screen CloudPAT Page 22 Operation Manual Itamar Medical Ltd 3 2 2 First Time Initialization The first time you run the Initialization process a small one time PC resident program will be downloaded from CloudPAT see Figure 16 If your system asks you for permission to run this application please enable to process by clicking Run as it is required for the successful connection to the WatchPAT device Application Run Security Warning MA Publisher cannot be verified Are you sure you want to run this application Name Itamar From Hover over the string below to see the full domain amp c2 50 19 234 147 compute 1 amazonaws com Publisher Unknown Publisher While applications from the Internet can be useful they can potentially harm your computer If you do not trust the source do not run this software More Information Figure 16 Message to download t
63. on ischemic heart disease and arrhythmias are the major sequel of OSAS in the adult population The WatchPAT device is worn on the wrist and utilizes a plethysmographic based finger mounted probe to measure the PAT Peripheral Arterial Tone signal The PAT signal is a measurement of the pulsatile volume changes in the fingertip arteries which reflects the relative state of the arterial vasomotor activity and thus indirectly the level of sympathetic activation Peripheral arterial vasoconstriction which mirrors sympathetic activation is shown as attenuation in the PAT signal amplitude The PAT signal is recorded continuously and stored on a micro SD card along with pulse rate derived from the PAT signal data from a built in pulse oximeter the sensor is mounted on an adjacent finger and an actigraph embedded in the device Following the sleep study in an offline procedure the recordings are uploaded to a web server and analyzed using the proprietary CloudPAT software CloudPAT uses the same algorithms as zzzPAT The study data can be downloaded to a local PC in case the whole night data needs to be viewed and the automatically detected events need to be revised manually using the ZZZPAT software This manual provides the information necessary for routine use of CloudPAT software CloudPAT Page 8 Operation Manual Itamar Medical Ltd 1 5 Terminology CloudPAT supports various types of users and entities o Office a pra
64. on to see the list of all diseases see Figure 35 You can enter filters disease name office include items from the global list to limit the search results Clicking on an existing disease name will display the disease details screen in which you can delete or edit details and save the changes see Figure 36 Note Click on the CSV icon if you want to obtain an Excel file containing a tabular presentation of the search results Home Settings Support Logout itamar Home View Reports Patients Manage Lists Medications Diseases Search for Diseases defined for my Office s csv Name p ome Y Include global list M Disease List Name Office A fib All Offices Anxiety disorder All Offices Arthriti All Offices Arthritis All Offices Day time sleepiness All Offices Depression All Offices Diabetes All Offices fi nt ar All Offices Frequent arousals gasping for air All Offices T All Offices Hypertension All Offices Morbid obesity All Offices Morning headaches All Offices Nocturia All Offices None All Offices Obesity All Offices A EEE LL Figure 35 Search for diseases screen CloudPAT Page 35 Operation Manual Itamar Medical Ltd Home Settings Support Logout tamar Medications Diseases Disease Details ote Figure 36 Disease Details screen On New tab you can add a new disease to the list If you are connected as user to more than one office y
65. 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 Should any term or provision of this License Agreement be declared void or unenforceable by any court of competent jurisdiction in any country or countries such declaration shall have no effect on the remainder of this License Agreement in such country or countries or on this License Agreement in other countries 9 NO WAIVER The failure of either party to enforce any rights granted to it hereunder or to take action against the other party in the event of any breach hereunder shall not be deemed a waiver by that party as to subsequent enforcement actions in the event of future breaches 10 GOVERNING LAW AND JURISDICTION This License Agreement is governed by the laws of the State of New York excluding its conflict of laws principles The United Nations Convention on Contracts for the International Sale of Goods shall not apply to any of the transactions contemplated by this License Agreement 11 ENTIRE UNDERSTANDING This License Agreement represents the complete and exclusive understanding between you and Itamar conc
66. ou will be asked to select the office for which the disease will be added Do not forget to click save after you add or change an item see Figure 37 Home Settings Support Logout tamar Home View Reports Patients Manage Lists Medications Diseases Disease Details mame id Figure 37 New Disease screen CloudPAT Page 36 Operation Manual Itamar Medical Ltd 4 Using CloudPAT as an Interpreting Physician 4 1 Main Access Screen When you sign in CloudPAT as an Interpreting Physician you will be presented with the Interpreting Physician s Home screen see Figure 38 Here are the main actions that can be selected from this screen 1 Review studies reviews new or displays completed studies 2 Manage templates and NPIs defines new or edits existing NPIs and templates used for Clinical diagnosis and recommendations while reviewing studies 3 Contact for help with any problems you experience with CloudPAT please contact us by clicking the contact link from any window This link leads to Itamar Medical CloudPAT Support Use the form shown in Figure 39 to send us a message with your problem description itamar A Studies Templates NPis ient ID Office Patient Last Name Patient First Name Study Date Study Load Date Figure 38 Interpreting Physician s Home screen ttamar Contact Us Send Cancel Your Name User Name 2i Your Email User itamar
67. rrors and proceed 3 Insert additional information as needed the rest of the fields are optional but filling the patient name is recommended for easier patient CloudPAT Page 18 Operation Manual Itamar Medical Ltd 4 CloudPAT management You may insert additional information after the study is saved to the device if necessary this information will be updated in the report as long as the report has not been signed yet More Details optional Figure 14 shows the ability to add More Details as the following Patient demographics Contact details Sync Clock select this option if the WatchPAT device clock needs to be set Bracelet Study available only if office setting permits from this screen you may require a Tamper proof Bracelet to be used as Positive Chain of Custody in Occupational Testing e g truck drivers See WatchPAT user manual for further details Pacemaker available only if office setting permits select this option if the patient has an implantable pacemaker The CloudPAT will automatically detect segments where the PAT pulses seem to be paced i e very low pulse rate variations near to stable and exclude these segments from the analysis Note Some types of pacemakers are excluding the use of the WatchPAT device See the exclusion criteria section of the device operating manual for more details If the office setting permits Multiple Nights Study in order to run up to 3
68. s section at report the bottom of the screen and Browse to the file and add Description Add additional files by clicking on the sign on the right o Select the box under the x to delete a file e Select Save to save your changes e Select Save and Lock Report to Lock report complete the process e Provider will be alerted automatically that PATIENT 1 the study is complete EA AO ATA Provider NO DONE CloudPAT Page 64 Operation Manual Itamar Medical Ltd Filla STOP BANG questionnaire E itamar wes Enter Log in to www cloudpat precisemd com CloudPAT e Enter your Username amp Password via the Web e Select Sign In E C O ar itamar hiipii e Select Patient either through Manage Patients or through Create New Study e Select nitiate Patient Questionnaire e You will receive an individual code which will be valid for 20 minutes only e The code starts with the Patient s ID and a I seve soie Device Get code is part of the 2 line message displayed on s EE ee s the screen T e Copy the code You will need it to start the questionnaire e On the laptop or tablet given to the patient Go to itamar e 4 Use code https cloudpat precisemd com sb aspx ose e Enter code in Code field E tnit e Select Start Session Select patient Find Patient Fill questionnaire Let the patient fill in the questionnaire
69. s sleep study 23 Fieure L7 Upload Study Sele COM s ees r as 24 Fisure H5 Upload Study Dialos DOK ui 24 Figure 19 Patient sleep study upload in progress cccocoooonnccnnnnnnnnononocnnnnnnnonononaninenoss 25 Eigure 20 Successtul upload SCIeGH ta ii 25 Figure 21 Select Interpreting Physician Dialog bOX oooocccccccccnnnoocccnnnnnnnonononancnnnos 25 E16016 22 Upload Complete Serena don 26 Fisure 25 Upload faled Cr sindicado 26 Ersure 24 Manual UD bi 27 Figure 25 Viewing Sleep Study REPO S A do 2 au GSA DU ee Geto Udri od ii ere Eden des 29 Ficure 2 7 Deleuns attached Tes issus oae e 30 Fip te 25 Rer m Analysis Messi 3l Figure 29 Report Details for reviewing sleep study reports ssssssss 22 Preure 31 Manage LIS Sri a 33 PISure 52 seal cl TOL fiie dic al lOIF Creta id ai 34 Figure 5 Medication Details Er ib 34 Fiure 34 New Medications cria 35 Froure 39 Barc fOr disease sS SCEOCTI GG i tbt r O 35 CloudPAT Page 4 Operation Manual Itamar Medical Ltd Figure 35 Figure 36 Figure 37 Figure 38 Figure 39 Figure 40 Figure 41 Figure 42 Figure 43 Figure 44 Figure 45 Figure 46 Figure 47 Figure 48 Figure 49 Figure 50 CloudPAT Disease Details Screen 36 New Disease SCIO II arica ida ninia pd dq isis 36 Interpreune Physician S Home Sres sist 37 Contac US a aa 37 Study Selection Scree eesis e TEES eS 38 Revie waew SUI ete viadd nce UE CUN se CV e
70. sident program will be downloaded see Section 3 2 2 9 A pop up application will open and manage the initialization of the device See section 3 2 3 for error handling in different cases Note Make sure to connect the device perform a device test and guide the patient before handing out the WatchPAT device Refer to the WatchPATTM operation manual for more details 10 The system will prompt you once the initialization process 1s completed Then you will be asked to select an Interpreting Physician for this study You will be able to change the Interpreting Physician during the upload process and later on once the study is uploaded from the study page As long as there is no Interpreting Physician leaving this field empty the report is not sent for interpretation and final report cannot be generated It is recommended to review the study and correct all the patient and study information that needs update before sending it to Interpreting Physician CloudPAT Page 21 Operation Manual Itamar Medical Ltd Note There are few patient details that might change the analysis See section 3 4 2 6 for more details Note The office can update the patient s details as long as the report wasn t electronically signed Once the report is electronically signed the modified patient data will not be included in the report To prevent double work for the Interpreting Physician and the need to open signed report it is rec
71. t 888 XXX XXXX there is another Support study resident on WatchPAT device CloudPAT Page 48 Operation Manual Itamar Medical Ltd amar Medical Watch PAT device Previous There is a Press Exit and upload this old Study sleep study study found still on WatchPAT device that has not been uploaded from the device Could not The PC does Make sure WatchPAT device is access notrecognize connected to the PC via the USB device WatchPAT M Select Retry TTE d s click the retry button below eviICC Click the exit button to return to the website Previous study found There is a previous study on t evice please use the upload study module to export device data before proceeding to initialize device Could not access device Upload Study screen Failed to The station Check your internet Send may not have connection Internet access Repeat the upload process Failed to The Itamar Save the study using zzzPAT Send Upload service Collect the data from the is temporarily device manually by copying unavailable all the files on the device and Zipping them Use manual upload at a later stage to upload the data in to the CloudPAT CloudPAT Page 49 Operation Manual Itamar Medical Ltd If you use this option contact Itamar Medical support to reset the device Failed to Mismatch Contact Itamar Medical support analyze a between for help CloudPAT Patient dat and study The
72. that any addition deletion or modification of entries will result in rerunning a i Figure 41 Review a new study Here are the main actions that can be selected from this screen i CloudPAT Analysis File link you can Click on the Analysis File link in order to see the two page report or more in case of a multi night study that was produced automatically by CloudPAT According to the Respiratory indices various statistics and sleep stages you will be able to make your interpretation and fill in the Diagnosis and Recommendations sections see Figure 41 View Questionnaire if the patient filled a STOP BANG questionnaire you will be able to view the results by clicking the View Questionnaire button Office Details by clicking the Office Details button you can see the following details of the office that sent the sleep study Name Address City State Zip Code Country Phone and Minimum Desaturation for AHI RDI calculation Preview report You can click the Preview report button in order to see the first page of the final report This page will present to you patient information as well as your interpretation as it was last saved see Figure 43 Download to zzzPAT if you wish to see more details on the study s signals or to review and edit the events you can use the Download to zzZPAT function in order to download a copy of this study to your local computer Page 39 Operation Manual It
73. wise trademarks of Itamar No right license or interest to such trademarks are generated or granted hereunder other than the limited right to use provided herein and you agree that no such right license or interest shall be asserted by you with respect to such trademarks You may not remove or destroy any copyright trademark logo or other proprietary marking or legend placed on or contained in the Licensed Software or a Licensed Product CloudPAT Page 67 Operation Manual Itamar Medical Ltd 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
74. wn on the CloudPAT Sign In screen see Figure 1 and after inserting the code the patient will be able to start the questionnaire Note If the patient will use the same computer as you make sure to logout from the system close the browser and reopen a browser before handing the computer to the patient to ensure data safety The questionnaire will be viewable in the patient screen form after patient submitted the questionnaire The last questionnaire of the patient will also be viewable by the Interpreting Physicians the study will be sent to Note Patient filled information will update any empty fields in the patient record but will not update fields that already had data in them If you want to update the patient record based on the newly entered information you will need to do it manually CloudPAT Page 20 Operation Manual Itamar Medical Ltd 4 More Details Additional Patient Details Height in EPworth Score Weight Ib Neck Circ in City Mobile Phone State v Pager Zip Code Email Figure 14 More Detail screen for patient data optional 7 Once the study definition is completed press Save and Initialize Device see Figure 13 8 The system will prompt you to verify that the WatchPAT device is connected to the computer and then you should continue by selecting Proceed with initialization see Figure 15 Note The first time you run the initialization process a one time PC re

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