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zzzPAT - Itamar Medical

1. 2 3 Installation of the Compact Flash drive Note Refer to the installation instructions provided with the Compact Flash drive e WP100 device only The provided Compact Flash drive may require the installation of a driver depending on the Windows operating system version and the type of Compact Flash drive Please refer to the instructions provided with the Compact Flash drive for installation instructions ZZZPAT 4 2 4 Operation Manual Itamar Medical Ltd Figure 1 USB attachment to the PC 2 4 Installing zZZPAT software This process will install a single Icon BS on the desktop which opens the zzzPAT analysis and reporting software To open the New Study and Database Wizard applications use the Start gt Programs gt zzzPAT command Quick start instructions e WP100 device only Verify that the Compact Flash drive is installed and plugged to the PC e Insert the zzzPAT CD into the computer s CD ROM drive e fthe CD ROM drive is set to run automatically the installation will begin automatically If installation does not begin refer to the section below e Follow the instructions on the screen If the installation does not start automatically e Double click the My Computer icon on your desktop Double click the CD ROM icon labeled zzzPAT Double click Setup exe Follow the instructions on the screen You are now ready to run the zzzPAT software See section 2 9 for instructions Before using zZZPAT S
2. 6 Tools 6 1 Tools gt Export Delete Allows the user to select the data of specific studies from the zzzPAT database and extract it to an archive database This action enables freeing space on the PC hard disk if needed and archiving the data in other locations Upon selection the Export dialog box will open Current Selection All Studies Wo FirstName LastName Study Date 1 Load Date Status Select All SAMPLE STUDY1 SAMPLE STUDY 02 07 2005 02 19 2005 Revie SAMPLE STUDY SAMPLE STUDY 02 08 2004 09 19 2004 Revie Unselect All Study Selection Start Export Start Archive Start Delete U selected out of 2 total studies DKE out of 33944 KE total Export to CSW Export for Name Interpretation Comment OB Connection Shared Figure 83 Export Dialog box This dialog box allows to export archive or delete study data e Export function Creates a file containing a copy of the selected study data as well as User s information for users associated with the exported files Original files are not removed from the database e Archive function Creates an archive file of the selected study data as well as User s information for users associated with the exported files and removes the original data from the database e Delete function Deletes the selected files from the database ZZZPAT 4 2 84 Operation Manual Itamar Medical Ltd e Export to CSV function Cre
3. User is not defined in Define user by zzzPAT administrator ZZZPAT Send report by ZZZPAT does not support Define Microsoft Outlook or Outlook email fails Netscape as the email Express as the default mail client application Changes to Events Events names are saved Run the analysis by selecting Names do not show with the saved analysis Analyze gt Reload Study and Analyze up on screen Changes will become visible only after running analysis again Errors while printing Non compatible printer A postscript printer driver provides the driver most reliable operation with the zzzPAT Install a suitable postscript driver for the printer in use and try again After clicking New Inadvertent double Press Alt Tab to bring the dialog box back Study in zzzPAT clicking the New Patient to the front the dialog box button may cause the disappears and dialog box to be hidden ZZZPAT is frozen in the background Enable multi night The WP200 has S W Upgrade the WP200 S W to the newest option does not version lower than S W call Itamar Help Desk for the show in New Study 2 2182 upgrade dialog Enable tamper The WP200 has S W Upgrade the WP200 S W to the newest proof testing option version lower than S W call Itamar Help Desk for the does not show in 2 2182 upgrade New Study dialog Table 3 Troubleshooting zzzPAT ZZZPAT 4 2 98 Operation Manual Itamar Medical Ltd Shared Access Mode zzzPAT Possible Cause Soluti
4. DEB Connection Local Figure 19 User Administration dialog box ZZZPAT 4 2 18 Operation Manual Itamar Medical Ltd e Click Add User The following dialog box will open User Details User Details Save User First Marne Last Name ID Title UR E Login Clear all Fields Password Demographics Extended Permissions Patient ID Modification Database Maintenance Finalizing Reports User Administrator Figure 20 User Details dialog box e User Details Fill all user details fields Demographics information is optional e Extended Permissions This section defines the functions each user is allowed to perform with the zzzPAT see Table 1 No extended permissions Basic User selected e Prepare a Compact Flash card for a new study e Load study into zzzPAT e Issue reports Patient ID Modification Basic User plus e Modify a patient s ID Finalizing report Basic User plus e Finalizing the report This action locks the current analysis so that no further changes can be made to the analysis and report Database Maintenance Basic User plus e Database export import delete backup restore and upgrade functions See section 5 System Administrator Basic User plus e Adding users to zzzPAT and defining their permissions e Customizing capabilities for the General Settings Table 1 User Permissions ZZZPAT 4 2 19 Operation Manual Itamar Medical Ltd To deactiva
5. Definition The zzzPAT is an analysis software package used with the WP100 or WP200 devices 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 WP100 or WP200 devices automatically identifies breathing disordered events and REM Light Sleep Deep Sleep stages and generates a comprehensive report for the physician 1 3 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 is 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 hypertension ischemic heart disease and arrhythmias are the major sequel of OSAS in the adult population The WP100 and WP200 are worn on the wrist and utilizes a plethysmographic
6. PAT Apnea Hypopnea Index pAHI the estimated number of Apneas and Hypopneas events divided by the valid sleep time Provided in Apnea and Hypopnea events Hour The index is calculated during All Night REM and Non REM valid sleep time Oxygen Desaturation Index ODI the number of oxygen desaturation events 4 minimum desaturation divided by the valid sleep time Provided in Desaturation Events Hour The index is calculated during All Night REM and Non REM valid sleep time REM of Sleep Time REM sleep stages as percent of total sleep time Snore level in dBs Because snoring can be a sign of sleep apnea zzzPAT provides snore statistics The threshold is determined according to DB The amount of snoring is calculated as the percentage of sleep time over the specified DB threshold The snoring volume level is graphically displayed 40 90 dB range Body Position Five body position levels are graphically displayed supine right left prone and sit Because the frequency of apneic events during sleep depends on patient position and sleep stage zzZPAT provides information about the duration of sleep per each position supine prone left right and sit The corresponding percentage of time spent in each sleep position is displayed in a graph Moreover all recorded events such as respiratory disturbance index RDI apnea hyperpnoea index AHI and desaturation index ODI are also provided in the report for each body positi
7. Study Custom Fields or insert free text into the fields of the Custom Fields section Note Up to three Custom Fields can be defined and named by the user If Study Custom Fields are not defined they will appear in the More Study Details Dialog box as read only Figure 44 To define Custom Fields see section 3 4 4 4 1 3 6 Reviewing and editing information stored on a Compact Flash Card Warning It is possible to change information on a Compact Flash card only before the recording session Changing information after a recording session will erase the recorded information on the Compact Flash card Insert the Compact Flash card into the Compact Flash reader Open New Study application Click Read From USB button If the information does not need to be edited click Exit Make any necessary changes and click Save to Flash Note Study details including patient information can be viewed and modified after the study is loaded from the Compact Flash card to the zzzPAT database See Section 4 2 7 for more details 4 2 Managing Patient Studies After a WP100 sleep study remove the Compact Flash card from the WP100 and insert it into the zzzPAT Compact Flash reader The recorded digital data along with patient information are loaded into the zzzPAT database The recorded data is automatically analyzed The user can subsequently review edit add Diagnosis and Recommendations and produce a Sleep
8. to get an alert message when available disk space is lower than 1GB e Check Enable Packed Studies Import if you have access to packed studies from ftp uploads By enabling this option you can import studies that were uploaded by ftp by selecting Tools gt Import Packed studies option from the main menu e For WP200 only Enable Tamper Proof Testing if you want to use the Patient Identification Bracelet By enabling this option you can select to use the bracelet while preparing a New study see Preparing a New Study e For WP200 only Check Enable Multiple Nights option if you want to enable the Watch PAT200 recording up to 3 nights in a row while preparing a New study see Preparing a New Study ZZZPAT 4 2 32 Operation Manual Itamar Medical Ltd Note The Enable Tamper Proof Testing and Enable Multiple Nights options are available only when the WP200 internal S W is version 2 2182 and higher Check Print label during New Study and set the label Printer and the number of labels if you wish to have labels automatically printed when you prepare New Study Details This feature will work only with pre defined label printers The printers must print at 3 secs label at a minimum and must be defined by Itamar Medical The information printed on the label 2x5 cm will include the following fields Patient ID Patient First and Last name Date of Compact Flash preparation and Coverage field that may be used for addit
9. 58 View gt Zoom In 59 View gt Zoom Original 59 View gt Zoom Out 59 AN Windows XP Permissions 97 Restrictions 2 Z ZZZPAT Installation 5 Upgrading 15 Using 37 Operation Manual
10. Body Position Snore SE ER Figure 24 Setting Montage of zzzPAT display To add a channel e Select the channel in the All Channels window and click Add To remove a channel e Select the channel in the Channels In Montage window and click Remove To change the order of appearance of the channels e Select a channel and then click 4 or Y until you reach the desired order 3 3 2 Setup gt User Settings gt Colors Colors Setup page Figure 25 consists of a list of all the display elements that can be colored allowing the user to personalize the screens The example area provides a preview of the selected color scheme This setting is saved in the User Profile file To change a color e Select a display element from the list e Click the Change Color button to select a new color The preview is displayed in the Example area ZZZPAT 4 2 23 Operation Manual Itamar Medical Ltd User Settings Montage Colors Options Display Element Example Background Vertical Grid Lines Time Text Marker Cursor General Event Respiratory Events Lead Events Other Event Test Active Event Text Horizontal Grid Lines Midline Signal Active Signal Current Page m All Night iow o Figure 25 Setting colors of zzzPAT display Note Be careful not to choose a color that blends into one of the background elements 3 3 3 Setup gt User Settings gt Options Defines if and when the Sleep
11. ICH dr RF fF RRe Resp Event Dnt nen CAE Signals Display Window C II Desature 0 d H A 2240 Sleep D Sleep D R Sleep L Sleep L Slee Sleep L 2100 Ep L Sleep L MI Wake Sleep D ga REM W Wake f Wal Ready DB Connection Shared REL Begin 03 45 09 15 05 30 35 PM Status bar WE Figure 48 zzzPAT display screen The Screen Header consists of zzzPAT patient s name ID number Analysis status date and time and the zzzPAT user s name Events determined by the Automatic Analysis are displayed on the Signals Display Window ZZZPAT 4 2 51 Operation Manual Itamar Medical Ltd Placing the mouse cursor on an event pops up a tool tip that contains e Event name e Event source Analysis or User e Start time e Duration 4 3 1 The All Night Window It is possible to view any channel you select in an All Night Window display even if you change the time base for viewing all the channels of the study e To display the All Night window navigate through View gt All Night Window check the All Night option Or View gt Channels The following dialog box will open Set Channels View Channels All Night OK St Cancel wm Stagediag iw Wisible Select All Name W PAT Hame Area W PAT Amplitude 12 5 Clear All Make Same Size Area 12 5 W PulseR ate 12 5 iw Dal 12 5 Actigraph 12 5 i Body Position 125 i Snore 12 5 w WII Stages 12 5 Attached Channel for General E
12. ZZZPAT 4 2 vi Operation Manual Itamar Medical Ltd List of Figures Fioure t USB attachnirent tothe PE ocupi a Eia 3 Figure 2 22ZPAT installation dialog DOX sssisissesscccatexcssesecszsecscaceatenecteaadexssesinsescaneverscremesesassivexeient 6 Figure 3 722PAT License Agreement EE 6 Figure 4 Customer Information dialog DOX 0 ccccceeeeeee cence ee ee cece eee sees eee sees RENE RENE RER EE RENE H Figure 5 Database Properties dialog DOX SEENEN ENK RENR ENEE EREREER ENEE NEREREN REENEN REENEN En H Figure 6 Database Destination dialog DOX EEN ERREREER ENNER ENNER REE REENEN REENEN REENEN 8 Figure 7 Choose folder dialog DX eege ege ee EEN 9 Figure 8 Application folder dialog DOX 2 ccecesceeceeeeeeeeeeceeeeeeeceeeeceeeeeneeeeceseeeeeseeeeeeeeeeeeeoeeeesees 9 Figure 9 Ready to Install dialog bOX ee Seege eege eege 10 Figure 10 Database Properties with Advanced options dialog DOX cccccceeseeeeeeeeseeeseneeeneeeneeeees 10 Figure 11 Shared Database dialog DOX ciscsiicciedecheseseanidaiesecensvelahensiidiguseecivuesveustetendeideatetanestansics 11 Figure 12 Database Properties Advanced Client dialog DOX cccceseeeeeeeeeeeeeeeeneeeeeneneneeenenenes 12 Figure 13 Shared Database server dialog bOX sssssssssnusnnnnunnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnmnnn 12 Figure 14 Select Server dialog DOX sirsa eens netuveseedinebenweeatnenie 13 Figure 15 Applications folder dialog
13. 1 20 8 48 0 48 3 Sleep GE a 4 13 9 14 0 HRDOI 18 9 H HU 13 2 HAHI 14 49 6 3 3 0 4 0 Supine ODl 6 5 EK UU 0 0 Snoring Statistics Snoring Level dB 40 z t gt 60 gt O gt OU gt Threshold 45 Mean 52 dB Sleep imin 343 8 167 7 52 8 DA 0 1 330 6 Sleep DO 4 45 7 15 3 0 1 0 0 STE Sleep Stages Chart Sleep Wake States Sleep Stages DR 31 13 Ought 45 77 O Deep 23 11 Total 100 00 make 11 45 E Sleep 95 55 Total 100 00 Respiratory Indices Chart pRDI 15 95 ODI 4 40 Indeg D K b Q Oo 87 61 24 Total Events Saz 00 John Coe 0000 00 0000 Page 3of3 Printed on 671 72008 F atient s ID was edited Figure 69 Third page of Sleep Report non USA version ZZZPAT 4 2 70 Operation Manual Itamar Medical Ltd 4 6 3 Report gt Sleep Report for Selected Time Range Generates a two page report that provides a summary of the subject s sleep study in a Selected Time Range that is selected by the user The Selected Time Range report has the following title on the header of each page Sleep Report for Selected Time Range Figure 70 Sleep Report for Selected Time Range Title To generate a report for a selected time range e highlight the desired section of the waveform in the Signals Display Window by clicking and dragging the mouse e click Report gt Sleep Report for Selected Time Range The first page of the report includes Patient Information the Sleep Stud
14. 2 Signals Display Window The signals display window is located under the All Night window It displays the channels that are selected in the View gt Channels menu 4 3 3 Channel Title Bar The Channel Title Bar on the left of the screen shows the titles of the channels being displayed and the y Scale of each channel 4 3 4 The Active Channel Clicking on a channel or a channel title activates that channel the color of the activated signal and titles will change A right button click on a Channel title activates the channel and opens a pop up menu with the following options ZZZPAT 4 2 54 Operation Manual Itamar Medical Ltd Fit to Window Ctrl F Invert Daka Remove From view vw Octive Signal w Show Channel Events Grid OnfOft Show Values w Show Y axis Properties Figure 53 Active channel pop up menu Fit to window Auto fits the active channel s signal so it occupies about 80 of the window s height Invert Data Inverts the y Scale and signal of the Active channel Remove from View Removes the currently active channel from the screen Active Signal Allows deactivating the signal Show Channel Events Allows option of showing or not showing the events in the Active channel Grid On Off Toggles the grid in the Active channel Show Values Shows the values for each data point on the Active channel effective only under maximum zoom Show Y axis Shows the Y axis v
15. 3rd optional page to Sleep report New options at General Settings Report Appearance for 1 2 or 3 page report Events report shows Resp Events RDI Resp Events AHI and 1 Operation Manual Itamar Medical Ltd desaturations only File gt New Study Details Removed all mandatory requirements except Patient ID A backup of the database for every day of the week will be automatically performed behind the scenes Automatic printout of labels 1 or 2 labels as configured while the Compact Flash is initialized with patient data Follow up report will show reviewed and reported studies Patient s weight and height appear in Sleep report Enable manual addition deletion of Respiratory events Export for Interpretation services option The valid sleep time used for the calculation of the respiratory indices appears in the second page of the report Base 6 0 June 2008 Version 4 2 56 e Report changes e Support of MS SQL server e New Study new patient fields e Follow Up Report changes e Light Deep Sleep stages Base 7 0 August 2008 Version 4 2 57 WP200 support Base 8 0 August 2009 Version 4 2 58 WP200 Patient Identification Bracelet support Multiple nights study ZZZPAT 4 2 iii Operation Manual Itamar Medical Ltd Table of Contents KL JINITRODUCTION TO THE ZIZPA eege Eed Eege 1 1 1 Intended Use of the Watch PAT100 amp Watch PAT200 cccsssssssccceeececcccceeeeeee
16. 88 Restore Dialog box ZZZPAT 4 2 89 Operation Manual Itamar Medical Ltd Warning Restoring a backed up database overwrites the current database replacing all the data it contained 6 5 Tools gt Export General Settings Export General Settings Export Folder C itamar medinal zezpat database Archives Browse Start Export Use Export General Settings in order to save a copy of the current settings DB Connection Local Figure 89 Export General Settings Dialog Box e Type the directory path or click Browse button to select the directory where the General Setting configuration file will be saved e Click Start Export ZZZPAT 4 2 90 Operation Manual Itamar Medical Ltd 6 6 Tools gt Import General Settings Import General Settings Import Folder CAitamar medicalzzzpat database E vpot Use Import General Settings to overste the curent general settings with an old copy Start Import of the settings The current general settings will be overwritten DB Connection Local Figure 90 Import General Settings Dialog Box Click Browse to select the directory of the General Setting configuration file Click Start Import to continue 6 7 Tools gt User Administration Please refer to Section 2 9 ZZZPAT 4 2 9 Operation Manual Itamar Medical Ltd 7 Database Wizard The zzzPAT Database Wizard contains three utilities Database Tools Allows an authorized administrator
17. Figure 63 The information filled in this screen will appear on the first page of the Sleep Report e Sign the report by typing in your name or choosing it from the name menu bar e Check the Set as Reported option to show that the current study analysis is final and that the Sleep Report is a final report for this analysis ZZZPAT 4 2 63 Operation Manual Itamar Medical Ltd Note Multiple analyses may be associated with a particular study A new analysis will be created when selecting the Analyze gt Reload Study and Analyze option on a study that had been previously Set as Reported Clinical Diagnosis i i Medical Information TE OF Medical History Medications DE Add Add Sleep Report a m Cancel Comments Diagnosis Recommendations Report Signed By z e Super User MM T Set as Reported Figure 63 Clinical Diagnosis dialog box ZZZPAT 4 2 64 Operation Manual Itamar Medical Ltd Note Once a study is Set as Reported any subsequent change to any of the Clinical Diagnosis dialog fields Reports gt Clinical Diagnosis will trigger the following warning message WW 277PAT Warning The current Analysis is Reported therefore it can not be modified Anew Analysis will be created Do you wish to continue Figure 64 New Analysis Warning message Click Yes to save a new analysis without overwriting the existing analysis Click No to cancel the new
18. File gt Close Study 50 File gt Exit 50 ZZZPAI 4 2 113 File gt Export Data 79 File gt Export Events 79 File gt Load Study and Analyze 48 File gt New Study Details 38 39 48 File gt Open Study 49 File gt Print 78 H Hardware Requirements 3 Help Prepare and Send Study to Itamar Medical 80 81 I Import to Database 87 94 O ODI 65 66 71 74 107 P pAHI 65 66 71 73 pRDI 65 71 74 107 pREM 66 107 108 Printing 78 Print a report 63 R Report 63 Clinical Diagnosis 63 Event Report 71 72 73 Patient Follow up Report 74 Sleep Report 65 67 Restore 89 95 A Setup gt Directories 21 Operation Manual Itamar Medical Ltd Setup gt Set Flash Drive 21 Setup gt Settings 21 25 Colors 23 Events 26 History 27 Medications 28 Montage 22 Report Appearance 34 Report Translation 35 Status Bar 55 Study Adding clinical information 44 Adding Demographic information 43 T Transferring a Study to Itamar Medical 79 U User Add User 18 Deactivate 20 User Administration 18 20 92 100 V View gt All Night Channel Fit to Window 58 ZZZPAI 4 2 114 View gt Activate Channel Fit to Window 58 View gt All Night Window 52 59 View gt Channels 52 54 56 View gt Fit To Window Mode 58 View gt Grid On Off 58 View gt Relative Time 58 View gt Set y Scale 56 View gt Study Details 51 View gt Time Base
19. 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 Ifthe Licensed Product contains a defect in design materials or workmanship and such Licensed Product is returned to Itamar within one 1 year of delivery of the Licensed Product to you Itamar will repair or replace the Licensed Product or issue a credit for the purchase price of the Licensed Product with the choice to repair replace or credit being within the sole discretion of Itamar The foregoing repair replacement or credit remedy will be your sole remedy for breach of the warranty set forth in this Section 4 b c As to Licensed Software Itamar warrants that for a period of ninety 90 days from the date of delivery of the Licensed Software to you the Licensed Software will under normal use be free from defects in 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
20. Mandatory Clear Page First Hame Last Name O Head From USE Date of Birth E Age Gender Male C Female Set USB Drive Height Weight b Neck Circ zx m Epworth E Exit Demographics Clinical Data Physician License First Name Last Name O Demographics Study Coverage Payment Code More Time Zone GMT 2 00 USB De F Ready for prepare New Study DB Connection Shared Figure 38 New Study Dialog Box for WP100 For WP200 only e Make sure the device is connected to the PC with the zzzPAT software using the USB cable e Click File gt New Study Details in zzzPAT or click the New Study icon S in the tool bar e The New Study dialog box appears ZZZPAT 4 2 39 Operation Manual Itamar Medical Ltd C New Study ZZZPAI 4 2 Patient Save To USB ID Mandatory Clear Page First Hame Last Name O Read From USB Date ofBith Age Gender C Male Female Set USB Drive Height lx weight b Meck Circ p d Epworth Exit Demographics Clinical Data Physician License First Name Last Name Och Demographics Study Coverage Payment Code More Study with Tamper Proof Testing Multiple Nights up to 3 nights i Synchronize P2000 clock with PC clack while Saving to USB WP2O00 clock 10 27 2009 19 30 USB Drive F Data not loaded load fi
21. Night window Toggles the grid in the All Night window Opens up the Signal Properties All Night dialog box see Figure 51 Signal Properties All Night Channel name PAT ampling rate 40 00 Hz Recording system WP100 Figure 51 Signal Properties All Night window Right clicking the mouse on the All Night channel Title to the left of the All Night display opens a pop up menu with the following options ZZZPAI 4 2 53 Operation Manual Itamar Medical Ltd Select Channel to Display d Fit bo Window Ctrl F Invert Data Remove From view Show Channel Events Show Respiratory Events w Show Y axis Properties Figure 52 All Night pop up menu Select Channel to Allows the user to choose which channel will be displayed Display in the All Night Display Window Fit to window Auto fits the channel s signal so it occupies 80 of the window s height Invert Data Inverts the y Scale and signal of the channel Remove from View Removes the All Night Window from the main screen Show Channel Events Allows option of showing or not showing all the events on the All Night channel Show Respiratory Allows option of showing or not showing only respiratory Events events on the All Night channel Show Y axis Shows the Y axis for the selected channel Properties Opens up a dialog box with the General Y Scale and View properties of the channel 4 3
22. Report Previously loaded studies can be opened and reviewed The remainder of this section assumes zzzPAT is running ZZZPAT 4 2 47 Operation Manual Itamar Medical Ltd Note When working in Shared Access mode it is important to login to the correct database in which the data needs to be stored Typically that should be the Shared database however if data was stored locally local login may be required 4 2 1 File gt New Study Details Prepares the Patient file on the WP100 Compact Flash card for a sleep study Section 3 4 2 2 File gt Load Study and Analyze This command loads the sleep study data from the Compact Flash card and saves it into the zzzPAT database While loading the data the message Loading Study Figure 45 appears on the screen indicating that the data is being transferred from the Compact Flash card to the hard disk and the patient file is saved in the database Loading Study Loading night study of patient Smith John Please wait It may take several minutes depending on your computer Figure 45 Loading Study dialog box At this stage Automatic Analysis is performed and the results are saved in the database After the Automatic Analysis is completed the results are displayed on screen see Figure 48 The user has the option to display the Sleep report or Sleep Indices report box automatically after loading a study see 3 3 3 When a multi night study is loaded all the ni
23. analysis request 4 6 2 Report gt Sleep Report Generates a one two or three page report that provides a summary of the subject s sleep study according to the settings in Setup gt General Settings gt Report Appearance section The first page of the report Figure 66 includes Patient Information the Sleep Study Information Referring Physician Medical history Diagnosis and Recommendations The second page Figure 67 presents the study results including Sleep Summary PAT Respiratory Disturbance Index pRDI PAT Apnea Hypopnea Index pAHI Oxygen Saturation Statistics including the Oxygen Desaturation Index ODI mean maximum and minimum oxygen saturation levels Oxygen Saturation analysis Pulse Rate statistics and REM Sleep analysis It also includes graphical displays of Respiratory Events Snore and Body Position chart in case a Snore Body Position sensor was used Oxygen Saturation Pulse Rate Wake Light Sleep Deep Sleep and REM stages The third page Figure 68 presents pie charts of sleep wake states and sleep stages as well as a Respiratory indices chart Definitions Sleep Time Total time in hours during which the patient is asleep PAT Respiratory Disturbance Index pRDI the estimated number of respiratory events divided by the valid sleep time Provided in Respiratory Events Hour The index is calculated during All Night REM and Non REM valid sleep time ZZZPAT 4 2 65 Operation Manual Itamar Medical Ltd
24. bOX sssssssnnsnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnmnnn 13 Figure 16 Installation completed dialog bOX s sssnssnssnnsnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnmnnn 14 Figure 17 Select USB Drive dialog DOX euer 16 Figure 18 zzzPAT database Wizard dialog box SEENEN REENEN RER EEN RER EEN REERENRE ENEE ENRER EEN ENN 17 Figure 19 User Administration dialog box c ccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeseeeeeeeeseneseneseaeseneseneaeneeeees 18 Figure 20 User Details dilog DO Xcecccereessesitwccswnihs at ba cewsiweacetlee aa a aaaea AKEE Aaaa 19 Figure 2 Select USB Drive dialog DOX tee ee ee 21 Figure 22 Set Directories dialog Dugend 21 Figure 23 Save settings for current user question s sssssssssssnnsnunnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnmnnn 22 Figure 24 Setting Montage of ZZZPAT display ee RRE EREEREEREE REENEN REENEN ENEE E EE 23 Figure 25 Setting colors of ZZZPAT display scceeceeeeeeeeeeeeeeeeeeeeeeeeeeaeeeeeeeeeeneseneseneseneseaeeenennaes 24 Figure 26 Setting Sleep Indices report DOX 2 ceceeceeceeceececee ce KEEN RENE EE ENEE R EEN RENE E NENNEN 25 Figure 27 General Settings Setting Dialog Box Events Tab REENEN REENEN ENNER 26 Figure 28 Save settings E d E 26 Figure 29 General Settings Dialog Box Medical History Tab c ccececceeceeeeeeeeeeeeeseeeeeeeeeeeees 27 Figure 30 General Settings Dialog Box Medicati
25. can operate in two modes Standalone for use on a single PC with a local database Shared Access for use in a networked environment where multiple zzzPAT stations access a single shared database Note It is strongly advised to coordinate the setting of shared access ZZZPAT operation mode with an Itamar Medical representative Extra training is crucial for proper operation The zzzPAT mode of operation is determined during installation as further described in the Installation section of this operation manual A Compact Flash reader drive is used to read the data recorded by the WP100 on a Compact Flash card Please refer to Section 2 2 for required PC configuration 2 2 Hardware Requirements 2 2 1 Hardware configuration Computer Pentium 3 450MHz minimum Pentium 4 1GHz or higher recommended CD ROM drive 1 available USB port Additional serial port is recommended XGA screen resolution minimum 1024 x 768 pixels Colors set to 16 bits or higher RAM 256MB minimum Free disk space 10GB minimum 60GB recommended disk on database drive and at least 1 2GB on boot drive ZZZPAT 4 2 3 Operation Manual Itamar Medical Ltd 2 2 2 Operating System Windows XP with Service Pack 2 and above Windows Vista Home Premium Windows Vista Enterprise Windows Server 2003 Note Software components needed for the proper installation of zzzPAT should be installed prior to zzZPAT installation OS service packs or latest OS updates
26. gt Settings gt Control Panel gt Date and Time gt Time Zone Note When you run Watch PAT Monitor version 2 1 45 1 and earlier with WP100 devices whose clock is set to GMT the Date Time test will fail As long as the difference between the WP100 device clock and the computer clock is equal to the GMT offset the device clock should be left unchanged 4 1 3 2 Synchronizing the WP200 device clock with the zzzPAT software Select the Synchronize WP200 clock with PC clock while Saving to USB option while preparing new study if the WP200 device clock needs too be set see Figure 39 4 1 3 3 Documenting additional information To add demographic information e Click the Demographics button see Figure 38 The following dialog box will open ZZZPAT 4 2 43 Operation Manual Itamar Medical Ltd Demographic Details Street UK City Cancel State ip Code Country Clear Al Phone Home ll ne Di Figure 42 Demographic Details Dialog box e Insert the information into the appropriate fields and click OK to save To add optional clinical information e Click the Clinical Data button The following dialog box opens ZZZPAT 4 2 44 Operation Manual Itamar Medical Ltd Clinical Data Medical History Acocwanass Cancel Acromegaly Micragnathia Buengers disease Cheyne Shokes breathing Chronic pulmonary disease Chronicfrecurrent allergic rhinitis sinusitis de Congenital heart di
27. index RDI e Desaturation index ODI e Rapid eye movement REM It also compares these to the normal average indices To produce the report for the patient 1 In the Report menu choose Report for Patient 2 Print the report by clicking on the Printer icon ZZZPAT 4 2 76 Operation Manual Itamar Medical Ltd Sleep Study Report Name of Patient John Dow Name of Referring Doctor Date of Study 2 3 2009 Dear John Dow would like to thank you for undertaking the Watch HAT ambulatory sleep study would now like to review with you the results that you recen ed Your total study time which is calculated from the time you turned the device on until you pulled it off wasb hrs 11 min But as we are testing for obstructive sleep apnea and are interested in the time that you were asleep your total sleep time was 5 hrs 9 min On average a person with normal sleep habits sleeps between 6 6 hours a night Looking at your sleep statistics we can learn some vital information Your apneashypoonea index abbreviated as AHI was found to be 10 6 This score is the average number of apnea and hypopnea events per hour of sleep during the night Apnea event is an episode of fully occluded breathing of more than 10 seconds and an hyponea eventis an episode of partial occlusion The normal range of the AHI score is 5 or lower Your respiratory disturbance index ROM was found to be 23 1 This score is calculated in a very similar way
28. name in the Add to Clinical Recommendation text box The Add button becomes enabled e Click Add To modify a Clinical Recommendation e Click on the listed Clinical Recommendations e Click Modify The Modify dialog box opens with the selected Clinical Recommendations name e Type in the change requested To remove a Clinical Recommendation from the list e Click on the listed Clinical Recommendations e Click Remove Note Clicking the Default Settings will revert to empty settings losing all user defined setting ZZZPAT 4 2 36 Operation Manual Itamar Medical Ltd 4 Using zzzPAT 4 1 Preparing a New Study Preparing the Patient file is a mandatory stage in the preparation of the WP100 or WP200 devices for a sleep study Before proceeding make sure that the Compact Flash reader drive was defined as described in Section 2 7 Warning For WP100 only Use only Itamar provided Compact Flash cards The Compact Flash cards used by the WP100 have a special format Compact Flash Cards with regular format will not work and their use will result in a failed test All references to Compact Flash cards in this user manual refer to Itamar supplied Compact Flash Cards only 4 1 1 Launching zzzPAT e Launch zzzPAT by clicking the zzzPAT icon BS on your desktop or navigate through Start gt Programs gt zzzPAT gt zzzPAT e lf the zzzPAT icon BS is launched the following login dialog opens 222PAT Login Logi
29. or method of use is covered by one or more of the following US patents 6319205 6322515 6461305 6488633 6916289 6939304 7374540 as well as any pending US patent applications and corresponding patents and or applications filed in other countries Itamar Medical Ltd 9 Halamish Gr P O Box 3579 Caesarea 38900 Israel Tel 972 4 617 7000 Fax 972 4 627 5598 www itamar medical com support itamar medical com C SP 207233 0473 SV 73485 ISO 9001 2008 and ISO 13485 2003 certified ZZZPAT 4 2 i Operation Manual Itamar Medical Ltd Revision Base 3 0 Revision Dote Description 1 Chapter_ Pages WE E NEE BEER A ovember 2003 Addition of workgroup functionality March 2004 February 2005 November 2006 ZZZPAI 4 2 Revised chapter order Added Index Combined to cover both versions 1 5 and 2 4 Addition of AHI Single Icon application Addition of file transferring option Time Range and Sleep Indices report User and General Settings Export to CSV Version 3 0 Improved REM Analysis Database Wizard functions are integrated within zzzPAT under Tools menu Direct Export of Studies to CD Writer Win XP only Patient ID can be edited Option to open Sleep report automatically after Load from Flash or Open Study Toolbar improvement Removed need for WP100 Device clock setting Removed Win 98 support Version 4 0 Added support for Snoring and Body position sensor Added
30. recordings which were scored manually according to the American Academy of Sleep Medicine AASM criteria This set of sleep studies was defined according to correct practice as a training set Once finalized a separate set of studies was used to validate the algorithms DEEP and Light sleep Epoch of Deep and light sleep are identified using the very same transformation of PAT amplitude and Pulse rate than for REM This Provides the full PAT Hypnogram ZZZPAT 4 2 108 Operation Manual Itamar Medical Ltd ZZZPAT analysis flow diagram Raw actigraph signal Automatic Sleep Wake Algorithm Continue to the next epoch ae Sleep Epoch Raw PAT signal Extract amplitude amp pulse rate from PAT pulses Substantial increase in the Substantial increase in the Substantial decrease in the local scaling exponent of local spectral ratio of i the local mean PAT amplitude the DFA of the PAT PAT amplitude amplitude ii the PAT pulse rate Weighted Sum Continue to the next epoch Continue to the next epoch Sum is above threshold ZZZPAT 4 2 109 Operation Manual Itamar Medical Ltd Automatic Sleep Wake Algorithm Sleep Epoch Automatic PAT Respiratory Event Detection PAT PAT Actigraphy Amplitude Pulse rate movements Attenuation acceleration Combined score Moderate CS2 Very High CS2 amp minor oxygen re saturation PAT Respiratory Even
31. reducing the size of the saved files to one study only e Using Windows Explorer navigate to the folder that contains the saved deleted files Program Files ltamar Medical zzzPAT Data zzDELETE and delete its content in its entirety To commence Archive Export or Export to CSV operations proceed with the following e Name the archive optional in the Name editing box Name can consist of up to 8 characters e Add comments if desired in the comments editing box e The exported archived files will be saved in a folder named in accordance with the following convention ZZZPAT 4 2 85 Operation Manual Itamar Medical Ltd Exported files zzExport_name_dd mm vw bh mm with name being the optional data entered by the user Archived files ZZARCHIVE_name_dd mm vw bh mm with name being the optional data entered by the user Export to CSV files zzzCSVExport_name_dd_ mm vw bb mm with name being the optional data entered by the user You can apply a filter to the files listed in the main field by clicking Study Selection The following dialog box will open Select Studies By Apply y Loaded Time Between EN 7001 and EN 2 2002 e O Ae and y Patent ID Close W B B EE P Status All Studies y Study Time Between y Patient Last Name Custom Fields W Unreviewed M Reviewed Hypertension W Reported MSLT Figure 85 Study Selection Dialog box To sel
32. sl Date Tested 11 21 2006 Patient Name Mary Smith waid4 Sleep Time hrs T min u E Rep Event ROD Resp Event AHN LL a Des aturation bjm e E z Duration e Event Hame Humber Total Mean TD Range Resp Event 56 Resp Event AHI 24 Desaturation 1 235 20 H 10 34 All Events D 11 21 2006 Mary Smith wp104 Printed on 11 26 2006 5 34 40F tl Page 1 of 1 Figure 71 Event Report 72 Operation Manual Itamar Medical Ltd Time Start Time End Time Duration is Percent Desaturation 1 00 46 1 21 22 10 4 Desaturation 1 59 40 2 20 34 20 4 Desaturation 2 00 17 2 20 53 10 4 Desaturation 2 02 01 20227756 24 a Desaturation 2 03 17 22357 14 4 Desaturation 2 05 17 2 26 03 20 4 Desaturation 2 13 41 2 34 19 12 4 Desaturation 2 77 05 2 9746 14 4 Desaturation D OH Up 6 15 51 14 4 Desaturation 5 59 27 6 20 24 31 5 Desaturation 6 02 44 6 23 44 a4 5 Desaturation 6 04 38 6 25 17 13 5 Desaturation 12 235 ZU H 10 34 Figure 72 Detailed Event Report Note Click on the upper right icon X to close the details screen and return to the main report 4 6 55 Report gt Sleep Indices This report provides a summary of study results including pRDI pAHI ODI and Sleep Time E Sleep Indices h Sil pRDI H DAHL DD ODL ER Sleep Time ohrs 37 min Figure 73 Sleep Indices report Note Generation of the Sleep Report will close the Sleep Indices report ZZZPAT 4 2 73 O
33. 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 ltamar s installation instructions failure to operate under conditions of normal use and in accordance with the terms of the documentation accompanying the Licensed Product and or the Licensed Software failure to maintain in accordance with applicable documentation accompanying the Licensed Product and or the Licensed Software alteration or any defects not related to materials or workmanship or in the case of Licensed Products design materials or workmanship This 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
34. to operate Extended Permissions See section 2 9 option in the zzzPAT this utility window is disabled Insufficient free space on Free enough disk space to exceed the hard disk minimum requirement of 100MB and try again Cannot Load Study There is less than Free enough disk space to exceed the function is disabled 200MB of free hard disk minimum requirement of 200MB and try space again ZZZPAT will not Some zzzPAT files may Uninstall and reinstall zzzPAT start or behaves be damaged overwritten unpredictably ZZZPAT 4 2 97 Operation Manual Itamar Medical Ltd The open file does File was saved with an Run the analysis by selecting not show REM older version of zzzPAT Analyze gt Reload Study and Analyze that did not have REM capabilities Events Report does The Report Appearance NA not show defined setting tab applies only header footer and to the Sleep Report logo Cannot generate Less than 100MB of free Free enough disk space to exceed the Sleep Report disk space minimum requirement of 100MB and try Sleep Report button again is grayed out No study is loaded or Open the desired study If the study is study is non valid open it may have invalid data and therefore is not usable User cannot log on On Windows XP and Ensure no other user left an open zzzPAT to zzzPAT Vista zZZPAT will not session on the PC If you cannot verify open if another session restart PC is open under a different user
35. to update and maintain the zzzPAT database User Administration Allows an authorized administrator to add users to zzzPAT application and define the permissions attributed to them See chapter 2 9 Configuration Tools Allows an authorized administrator to Export and Import the General Settings e Select Start gt Programs gt zzzPAT gt Database Wizard zzzZPAT Database Wizard Login ER ee Cancel Password DB Connection Figure 91 Database Wizard Login e Enter Login and Password and select the desired database Connection e The Database Wizard will open ZZZPAT 4 2 92 Operation Manual Itamar Medical Ltd TE 522PAT Database Wizard Database Tools User Administration Configuration Tools I s alt li f 1 A DB Connection Local Figure 92 Database Wizard 7 1 Database Tools Click on the Database Tools icon Tip The following dialog box will appear ZZZPAT 4 2 93 Operation Manual Itamar Medical Ltd Database Tools Wizard Export from Database Import to Database Backup Restore DB Connection Shared Figure 93 Database Tools Wizard dialog box 7 1 1 Export From Database e Click the Export From Database Icon IMBC in the Database Tool Wizard window e Refer to Section 6 1 for a detailed explanation of the exporting procedure 7 1 2 Import to Database e Click on the Import to Database icon in the Datab
36. 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 T TRANSFERABILITY You may only transfer or assign the rights and obligations hereunder together with the Licensed Software and or the Licensed Product or Third Party Product as a whole without retaining any rights or subject to Sections 2 and 3 above any obligations arising after the date of such transfer or assignment or retaining any installed or uninstalled copy of the Licensed Software the Licensed Product or the Third Party Product Any attempt by you to rent lease sublicense assign or transfer any of the rights duties or obligations hereunder in any other way is forbidden and shall be null and void 8 SEVERABILITY 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 d 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 sh
37. you can use Itamar does not warrant that the functions of the Licensed Software will meet your requirements or that the operation of the Licensed Software ZZZPAT 4 2 103 Operation Manual Itamar Medical Ltd will be uninterrupted or error free Itamar is not responsible for problems caused by changes in the operating characteristics of the hardware or operating system software you are using nor for any problems in the interaction of the Licensed Software with non ltamar software ITAMAR HEREBY DISCLAIMS WITH RESPECT TO THE LICENSED PRODUCTS AND THE LICENSED SOFTWARE ALL OTHER WARRANTIES AND CONDITIONS WHETHER EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO ANY WARRANTIES OR CONDITIONS OF OR RELATED TO MERCHANTABILITY FITNESS FOR A PARTICULAR PURPOSE ACCURACY OR COMPLETENESS OF INFORMATION LACK OF NEGLIGENCE AND CORRESPONDENCE TO DESCRIPTION 5 LIMITATION OF LIABILITY A TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW EXCEPT FOR DAMAGES ARISING 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 INNO EVENT SHALL ITAMAR BE LIABLE FOR ANY SPECIAL INCIDENTAL INDIRECT OR CONSEQUENTIAL DAMAGES WHATSOEVE
38. z t Cancel Wake Wake wake Resp Event R E Resp Event HEM HEM FEM L Sleep L Sleep L Sleep D Geen D Geen D Sleep Figure 58 Add Event dialog box e Select Channel Allows user to define the channel on which the added event will appear by default the events will appear on the active channel unless a different channel is selected in the Select Channel field e To add event Double click on the event type in the list of events Click OK to continue e tis also possible to add free text events into zzzPAT signal display using the Free Text editing box This text will appear on the signal as an event but will not appear in the report The changes in the database are saved by pressing the Save study results button 4 5 7 Deleting an Event An event can be deleted by right mouse button click on the event and selecting Delete Event Only Respiratory and user events can be deleted ZZZPAT 4 2 61 Operation Manual Itamar Medical Ltd Note Adding or deleting a respiratory event affects the results in the report 4 5 8 Events gt GoTo Event Allows the user to navigate through the study by certain event criteria The following event type search options are available Previous Event Chri Left arrow Mest Event Cbri Right arrow Previous Same Type Event Shift Left arrow Next Same Type Event Shift Right arrow First Event For channel Ctrl Home Last Event for channel Ctrl End Figure 59 Eve
39. zzzPAt InstallShield Wizard From the list of servers below select the database server you would like to target VEENGSPO INTDCOWZ2250 Figure 14 Select Server dialog box The zzzPAT Installer will assist in selecting a destination location for the zzzPAT application files If you wish to change the default folder select the Change button zzzPAt InstallShield Wizard Application Folder Click Next to install to this Folder or click Change to install to a different Folder Install 222P 4T bo ES Files Itamar medicaltzz2P4T This folder will hold all me PAT components programs utilities help files ete Figure 15 Applications folder dialog box ZZZPAT 4 2 13 Operation Manual Itamar Medical Ltd Press Next to proceed The last dialog before client installation summarizes your selections After reading this summary press Install to begin the installation At the end of the installation the final dialog is displayed i zzzPAt InstallShield Wizard Itamar InstallShield Wizard Completed The InstallShield Wizard has successfully installed zzzPAT Click Finish to exit the wizard Show the readme File Figure 16 Installation completed dialog box At the end of the installation you should restart your computer Note A login name and password are needed to operate this software The default administrator login information is Login name 111 Login password 111 To modif
40. 36 General Settings Dialog Box Report Translation Tab To translate report headings to a different language e All report field labels may be changed by selecting the desired report field and clicking Modify In the dialog box that opens you can type the new text to be used in the reports Report Translation Clinical Diagnosis Clinical Recommendations e Click Default Settings to revert to the default text for all report field labels Note Clicking the Default Settings will revert to default settings losing all user defined report labels ZZZPAI 4 2 35 Operation Manual Itamar Medical Ltd 3 4 8 Setup gt General Settings gt Clinical Diagnosis To add a Clinical Diagnosis to the list e Insert Clinical Diagnosis name in the Add to Clinical Diagnosis text box The Add button becomes enabled e Click Add To modify a Clinical Diagnosis e Click on the listed Clinical Diagnosis e Click Modify The Modify dialog box opens with the selected Clinical Diagnosis name e Type in the change requested To remove a Clinical Diagnosis from the list e Click on the listed Clinical Diagnosis e Click Remove Default Settings reverts to the default empty list Note Clicking the Default Settings will revert to empty settings losing all user defined setting 3 4 9 Setup gt General Settings gt Clinical Recommendations To add a Clinical Recommendations to the list e Insert Clinical Recommendations
41. 5 An Mean 96 Minimum HU M ax inu rm Hu End Study Time 12 09 23 PM Mean of Desaturations Madis g3 Total Study Time hrs 28 min Oxygen Desair Fa 4 9 410 20 gt 20 Total Sleep Time 5 hrs 44 min Events Number 0 24 REM of Sleep Time 31 1 Total UU 100 0 Respiratory Indices Oxygen Saturation Duration minutess HREM All Hight Sleep Pulse Rate Statistics during Sleep BPM Mean AS Minimum 39 Wi aximurn BA maites are calculated using vaid steed tive of Sars 27min PAT Respratory Events Excluded penods Pulse Rate BPM Wake Sleep stages Wake REM L Sleep D Sleep ef fa Es g7 af P Es Es af Es a7 A Af OGO 200Dp John D oe DOD0D D0 DO0D0 Page 2 or Printed on 64 72008 Patient s ID was edited THIS UNEIS FOR ADDRESS AND AFFILIATION Figure 67 Second page of Sleep Report ZZZPAT 4 2 68 Operation Manual Itamar Medical Ltd Sleep Study Report Sleep iake States 31 13 23 11 d EN 100 00 Wake 11 45 E Sleep 99 55 Total 100 00 Respiratory Indices Chart ge ODI 4 40 Les Total Events pRDI 15 95 SfZOV2006 John Coe 000 000 0000 Fage 3 0of3 Frinted on Di 72008 F atie nt s ID was edited Figure 68 Third page of Sleep Report USA version ZZZPAT 4 2 69 Operation Manual Itamar Medical Ltd Sleep Study Report leer erat eet E vie Rte Ui Body Position Statistics Position Supine Prone Right Left Sleep imini 215
42. 7 Operation Manual Itamar Medical Ltd To zoom on a specific range of the channel e Right click and drag to the desired range 4 4 3 View gt Time Base Enables to select the time base by which the study is viewed on the zzzPAT screen It is also possible to select the time base by using the Time Base Drop Down Menu in the ZZZPAT tool bar 4 4 4 View gt Activate Channel Fit to Window Sets the signals display to automatically take 80 of the selected signal s window height The size of the signal will automatically adjust to take no more than 80 of the vertical axis of its display Automatic Fit to Window mode is applicable only for the section being viewed on the screen It will be disabled when viewing the study by paging using the Page Up and Page Down keys on the keyboard or when scrolling using the Right Arrow and Left Arrow keys on the keyboard 4 45 View gt All Night Channel Fit to Window Activates the Fit to Window mode on the All Night Channel 4 4 6 View gt Fit To Window Mode This command activates a Fit To Window mode on all the displayed channels In this mode the size of the signal will automatically adjust to take no more than 80 of the vertical axis of its display All the channels will remain in Fit to Window mode when viewing the study by paging using the Page Up and Page Down keys on the keyboard or when scrolling using the Right Arrow and Left Arrow keys on the keyboard Note It is recomme
43. C Program Files ltamar medical zzzPAT Misc If the Compact Flash card WP200 contains data either a night study that has not been loaded to the zzzPAT Database or new patient data that has been prepared but not used in a study the following dialog box opens MS New Study Error Figure 40 Compact Flash Card WP200 Not Loaded Dialog Box e After saving the patient information to the Compact Flash card WP200 the following message appears ZZZPAT 4 2 41 Operation Manual Itamar Medical Ltd WW ltamar Medical Question LY The new study information has been successfully saved on the flash disk Do you wish to prepare another study Figure 41 New Study Termination Question Click Yes if you wish to prepare additional Compact Flash cards Click No if you wish to exit the New Study dialog box e For WP100 only Take the Compact Flash card from the Compact Flash reader and insert it into the appropriate compartment in the WP100 Refer to the WP100 user manual e For WP200 only Disconnect the USB cable from the WP200 device 4 1 3 New Study screen features Besides the main screen fields required for preparing a new study there are additional fields that allow thorough documentation of the patient s past and current medical condition In addition zzzPAT enables you to load patient details from previous studies Other features in this screen enable organizing the studies into groups using categories of your ch
44. Itamar ZZZPA I For Watch PAT100 amp Watch DAT 200 Software Operation Manual Itamar Medical Cat No OM2197432 mm mm Physiology PAT signal Pe pheral a aria e Sleep related z aie ne rez i i di H Ze gr i toned on ER ja BI JEC EE E ep Ale a o gl e l a a fo oe e E Es Oeh Ce e mmm P LN a mmm E emm lt lt PS er geng 29 ig al ina lag PAT Algorithms SS Auto analysis m re E Caution Federal U S law restricts this device to sale by or on the order of a physician Copyright 2002 2009 By Itamar Medical Ltd Software Version 4 2 58 Itamar Medical Ltd This manual and the information contained herein are confidential and are the sole property of 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 A This product and
45. OW 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 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 internation
46. R ARISING OUT OF OR IN ANY WAY RELATED TO THE USE OF OR INABILITY TO USE THE LICENSED SOFTWARE AND OR THE LICENSED PRODUCT AND OR THE THIRD PARTY PRODUCT OR THE PROVISION OF OR FAILURE TO PROVIDE SUPPORT SERVICES BY ITAMAR EVEN IF ITAMAR HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH CONSEQUENTIAL DAMAGES THE FOREGOING DISCLAIMER OF CONSEQUENTIAL DAMAGES SHALL BE APPLICABLE REGARDLESS OF WHETHER THE ACTION GIVING RISE TO SUCH DAMAGES IS IN TORT CONTRACT STRICT PRODUCTS LIABILITY OR OTHERWISE C IN ORDER TO BE ENTITLED TO INDEMNIFICATION HEREUNDER IN CONNECTION WITH AN INFRINGEMENT CLAIM YOU MUST i NOTIFY ITAMAR IN WRITING PROMPTLY UPON BECOMING AWARE OF AN INFRINGEMENT CLAIM OR THE POSSIBILITY THEREOF ii GRANT ITAMAR SOLE CONTROL OF THE SETTLEMENT COMPROMISE NEGOTIATION AND DEFENSE OF ANY SUCH ACTION AND iii PROVIDE ITAMAR WITH ALL INFORMATION RELATED TO THE ACTION THAT IS REASONABLY REQUESTED BY ITAMAR 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 ZZZPAT 4 2 104 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
47. Report or Sleep Indices report is displayed automatically ZZZPAT 4 2 24 Operation Manual Itamar Medical Ltd User Settings Montage Colors Options CO Sleep Report report f Sleep Indices report Open report after Open Study ie e Enable Sleep Stages Editing Figure 26 Setting Sleep Indices report box You can select to open a report either after Load Study and Analyze by selecting Open report after Load Study and Analyze or and for existing study by selecting Open report after Open Study Both options contain radio buttons that enable you to select between Sleep Report and Sleep Indices report e When selecting Sleep Report report the sleep report opens automatically e When selecting Sleep Indices report the sleep indices report appears automatically on display and the sleep report opens upon command You can select Enable Sleep Stages Editing if you want to be able to edit manually the Sleep stages see Editing Sleep Stages 3 4 Setup gt General Settings Only a user with User Administration permission can change the following Setup parameters by opening the General Settings dialog box from Setup gt General Settings General Settings are stored in the zzzPAT database either the local database in a standalone installation or the shared access database in a Shared Access installation These settings are global Modified settings becom
48. a list of logged Archives in the database By default all archives will be displayed in the Old Archives Logged in Database list The user can filter the archives displayed in this list by certain criteria Note If the database was overwritten while upgrading zzzPAT or the database was erased due to restoring a back up database into it no archives will displayed in the Old Archives Logged in Database Field To filter the archives that will be displayed in the Old Archives Logged in Database field e Select the Old Archives Logged in Database radio button e Click on the Archive Selection button The following dialog box will open Select Archives Dy i Appl w By Study Time Between EN 2 2001 dl and EN 2 2002 ee l All Archives By Patient ID By Creator Des Bu Comment By Name Figure 87 Select Archive Dialog box Check the criteria by which you want to select the Archive Insert the appropriate parameters for selection Click Apply Click Close to return to the Import dialog box You can restore the default display of all archives by clicking the All Archives button e Select the Archive you wish to import Once an Archive has been selected all its studies will be displayed in the Selected exported studies fields of the Import dialog box ZZZPAT 4 2 88 Operation Manual Itamar Medical Ltd e You can select individual studies you wish to retrieve by click
49. al 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 PAT100 Watch_PAT100 the Site PATI ZOU the PAT Probe and the corresponding components of any Third Party Product with which this License Agreement was received Some Licensed Products are stand alone products and some Licensed Products are incorporated as components within Third Party Products in each case sold or otherwise made available by Itamar and or third parties If you have received this License Agreement with a Third Party Product this License Agreement applies only to the Licensed Product incorporated as a component within such Third Party Product ZZZPAT 4 2 101 Operation Manual Itamar Medical Ltd 1 2 Licensed Software means the zzzPAT software Watch PAT Monitor software and the associated media and accompanying materials provided to you with such zzzPAT 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 t
50. all not be deemed a waiver by that party as to subsequent enforcement actions in the event of future breaches 10 GOVERNING LAW AND JURISDICTION This License Agreement is governed by the laws of the State of New York excluding its conflict of laws principles The United Nations Convention on Contracts for the International Sale of Goods shall not apply to any of the transactions contemplated by this License Agreement 11 ENTIRE UNDERSTANDING This License Agreement represents the complete and exclusive understanding between you and Itamar concerning the license by Itamar to you of Licensed Software and Licensed Products and supersedes all prior agreements and representations between the parties with respect to the subject matter hereof unless specifically stated otherwise in a writing signed by Itamar and you This License Agreement may not be ZZZPAT 4 2 105 Operation Manual Itamar Medical Ltd 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 38900 Israel Facsimile 972 4 627 5598 or visit Itamar s web site at www itamar medical com ZZZPAT 4 2 106 Operation Manual Itamar Medical Ltd Appendix B TECHNICAL SUPPLEMENT The zzzPAT uses a set of algorithms and provi
51. alues for the Active channel Properties Opens up a dialog box with the General y Scale and View properties of the Active channel 4 3 5 Status Bar The Status Bar at the bottom of the screen contains the following information e Database connection Shared or Local e Real Time Clock e Highlighted segment start time e Highlighted segment end time e Duration e Time mode REL ABS BB Connection Local REL Begin 02 12 43 435 End 02 14 34 90 Dur 0 01 51 47 10 21 54 AM Figure 54 zzzPAT screen Status Bar ZZZPAT 4 2 55 Operation Manual Itamar Medical Ltd 4 4 Signal Display Options 4 4 1 View gt Channels Opens the following dialog box Set Channels View Channels All Might Se Cancel Mien iw Wisible Select All Name W PAT Hame Area w PAT Amplitude 12 5 Clear All Make Same Size Area 12 5 if Dusel ate 12 5 w Dal 12 5 12 5 Mw WII Stages 12 5 i Body Position 125 W Snore 125 W Actigraph Attached Channel for General Events PAT Figure 55 Set Channels View Dialog Box The All Night section is used to enable disable the All Night display and to select the channel for it Checking the boxes by the channel names defines the channels displayed on the zzzPAT screen The value entered into the Area fields determines the channel s screen display relative size The total sum of the values in the Area fields should be 100 Clicking the Make Same Size button rescales al
52. anual Itamar Medical Ltd H After reading the agreement select accept the terms in the license agreement and click Next gt to continue The Customer Information dialog box appears ig zzzPAT InstallShield Wizard Customer Information Please enter your information User Name Organization Itamar Medical Ltd LD key H H H H Figure 4 Customer Information dialog box 4 Enter user name company name and the serial number exactly as it appears on the cover of the zzzPAT installation disk gt Click Next gt to continue The Database Properties dialog box appears zzzPAT InstallShield Wizard Database Properties Select database properties IF you select to Install the shared database Client you must ensure that a server is already installed Standard Standalone When no sharing of fhe data is required between several PCs When multiple PC s need fo access a central O Advanced Client Server a PAT database over the network Cancel Figure 5 Database Properties dialog box ZZZPAT 4 2 7 Operation Manual Itamar Medical Ltd 2 5 1 Installations types The zzzPAT software can be installed as a standalone or as a client server configuration e Standalone intended for users that do not require sharing that database with other ZZZPAT stations e Client Server intended for network installations with multiple zzzPAT stations accessing a central zzzPAT database over
53. ase Tools Wizard window e Refer to Section 6 2 for a detailed explanation of the importing procedure 7 1 3 Backup f gt e Click onthe Backup icon in the Database Wizard Tools window e Refer to Section 6 3 for a detailed explanation of the backup procedure ZZZPAT 4 2 94 Operation Manual Itamar Medical Ltd 7 1 4 Restore Sp e Click on the Restore icon in the Database Wizard Tools window e Refer to Section 6 4 for an explanation of the restoring procedure 7 2 User Administration Please refer to Section 2 9 7 3 Configuration Tools Used to copy General Settings from one zzzPAT station to another see Figure 92 Click the configuration tools Icon Configuration Tools Wizard Sen Se Export General Settings cf Import General Settings 1 asi ubi dn aay l aia ug TE Ch 3 JO A Kalen KAS al AS JE U poe ii fi i ul A DB Connection Local Figure 94 Configuration Tool Wizard e Click the Export General Settings icon to save the current General Settings configuration ZZZPAT 4 2 95 Operation Manual Itamar Medical Ltd e Click the Import General Settings icon to apply a saved General Settings configuration 7 3 1 Export General Settings e Click the Export General Settings icon CH e Refer to Section 6 5 for a detailed explanation of the general settings exporting procedure 7 3 2 Import General Settings e Click th
54. asthe AHI but an additional type of respiratory events named RERA are also counted RERA is the abbreviation for Respiratory Effort Related Arousal and is essentially a very short arousal of afew seconds that follows partial occlusion of the airways The normal range of the RDI score is also 5 or lower Your oxygen desaturation index ODI was found to be 5 4 This score is the average number of times the oxygen in your blood dropped by 4 or more during an hour of sleep As you can imagine the more your oxygen drops the harder the heart must work The normal range of the ODI is 5 or lower Looking at your REM sleep stage Rapid Eye Movement we find that you were in this stage 20 9 of your sleep time REM sleep is very important as during this stage your body is being replenished and nurtured The normal range ofthe REM score is between 15 to 30 pending some other conditions REM stage is also believed ta be the time during which we dream lf can be of any further assistance please contact my front desk to make an appointment Regards Printed an 107 2772009 Figure 75 Letter to the Patient ZZZPAT 4 2 77 Operation Manual Itamar Medical Ltd 4 6 8 Printing ZZZPAT offers the user several printing options This section describes various options of printing the displayed signals zzzPAT reports printing is described in Section 0 4 6 8 1 File gt Print The study signals recorded by the WP100 and the zzzPAT analysis can be printe
55. ates a file named zzzPAT csv which contains in one line all the Patient Study Physician and Analysis fields information In case that a study has two different analysis the data will be exported in two lines one line for each entry Note Sleep Statistics values will be empty in CSV export for studies that had not a report issued e The Delete function has two options as seen in Figure 84 e Delete files and save a temporary copy The deleted files are saved to a temporary folder overwriting the previously saved files from the last time the function was used and the option to save a temporary copy was chosen this function always uses the directory ltamar Medical zzzPAT Data zzDELETE to save the deleted files e Delete studies permanently The deleted files are deleted permanently Delete C Program Files sltamar Medicalhzz2P47 Data z20ELETE Delete studies permanently Selected studies will be removed permanently from database Figure 84 Delete studies options Dialog box e Temporarily saved deleted files can be restored by using the Import function of the Database Tools see section 7 1 2 e The temporarily saved file can be deleted from the hard disk e g to free disk space by following one of the below listed procedures e Delete one more study and select Delete studies Save temporary copy Im By doing so the previously saved deleted studies will be replaced by the single study deleted now thus
56. based finger mounted probe to measure the PAT Peripheral Arterial Tone signal The PAT ZZZPAT 4 2 l Operation Manual Itamar Medical Ltd 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 removable flash disk 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 automatically downloaded and analyzed using the proprietary zzzPAT software The zzzPAT algorithms use the four WP100 or WP200 channels PAT Pulse Rate Oxygen saturation and actigraphy for the detection of sleep related breathing disorders and sleep staging Rapid Eye Movement REM Light Sleep Deep Sleep and Wake The software issues comprehensive reports of the study with statistics and graphic presentation of the results The whole night data can be viewed and the automatically detected events can be revised manually This manual provides the information necessary for routine use of the zzzPAT software Restrictions The tracings and calculati
57. clear the selected logo click Clear Logo To add a header footer to the sleep report e Type in the desired header text in the Headers field e Type in the desired footer text in the Footer Field To set the number of pages of the Sleep Report e Select One page Sleep Report to see the results statistics and signals page ZZZPAT 4 2 34 Operation Manual Itamar Medical Ltd e Select Two pages Sleep Report default to see patient physician and study information in addition to the One page Sleep Report e Select Three pages Sleep Report to see sleep wake states sleep stages and respiratory indices charts in addition to Two pages Sleep Report 3 4 7 Setup gt General Settings gt Report Translation Used to change the sleep report headings General Settings Events Medical History Report ppearance Default Report Label Sleep Study Report Patient Information First Name Last Name ID Birth Date Insurer BMI Address Sleep Study Information Study Date S HA Version Study H Referring Physician Information First Name Last Name Medications Custom Fields General Options Current Report Label Modify Sleep Study Report Patent Information First Name Last Name ID Birth Date Age Gender Insurer BMI Address Sleep Study Information Study Date SHA Version Study H Referring Physician Information First Name Last Name Default Settings Figure
58. csccdssicsssdasensiadssccodediacsicadsevesievacaveiedsauincedeasveiudsasiaceantevecucdasensetedess 56 4 5 Review Analysis and Report Study c cssscscsscccrsssssscsssssscccssccsssscsssccossccesssssscccssseeoees 59 4 6 IRE DOEUS sicaire aaea a a E a E e E A 63 EXPORTING DAT A iii a Ea 79 5 1 File Export Ata EE 79 5 2 File gt Export Events Creating txt Rule eege 79 5 3 Tools gt Export ET EE 79 5 4 Tools Export EE HE E 79 5 5 Transferring a Study to Itamar Medical cccssccccccssssssssscsccccccccsssssssccccsscscsssscsccsoees 79 CS Kg 8 7 DE 84 6 1 Tools Export Delete E 84 6 2 Tols Import E 87 6 3 Tool Bae E 89 6 4 AET AL A A E A E E I E A N E A E 89 6 5 Tools gt Export General Settings edd 90 6 6 Tools gt import Lenert 91 6 7 Tools USer lte e 91 T DATABASE ee ee 92 7 1 Database TOONS E 93 7 2 User Administr atio EE 95 7 3 CONMPUT ATION Kr E 95 5 TROUBLE SHOO TING sicesecvesactevck cee tectt erase cececsceeaecs reece tanteaseki cies eeieve coviodcadacacastausedeuctae 97 APPENDIX A LICENSE AGREEMENT eege eege EE ENEE 101 APPENDIX B TECHNICAL SUPPLEMENT cccccsccccccssensesensensencescnsensesensensensescnecnscnsaeees 107 ZZZPAT 4 2 V Operation Manual Itamar Medical Ltd APPENDIX C KEYBOARD SHORTCUTS 20 cece ccc ccc cece ce cece eee eee eee eee sees ENNEN REENEN EEN RE RENE 111 APPENDIX D MANUAL SLEEP DATA SIGNAL TRANSFER eee cece eee ee nescence eeeeeeeees 112 APPENDIX E INDEX EE 113
59. d above Under certain conditions REM analysis is unable to conclusively determine REM periods from the recorded signals When this occurs the display will include only sleep and wake stages and in the report the REM statistics section shall be disabled stating Inconclusive REM Detection 4 5 2 Event Management Events marked by automatic analysis are shown in color shaded boxes Placing the cursor on an event opens a tool tip with the following information e Event name e Event created by e g Automatic analysis or user e Start time e Duration 4 5 3 Edit gt Copy When a signal section is highlighted the Copy feature is enabled to allow user to copy the desired data either to the clipboard as an image or to files in binary format 4 5 4 Edit gt Undo Undo is enabled only after changing events enabling the user to undo the last operation 4 5 5 Edit gt Redo Redo is enabled only after using the Undo option enabling the user to redo the last operation 4 5 6 Adding events Respiratory and user defined events can be added to the study by the user To add events e Mark the place you want to insert the event by clicking on the location with the mouse e Right click on the location and select the Add Event command Or by using the zzzPAT tool bar Events gt Add Event The Add Events Dialog box will open ZZZPAT 4 2 60 Operation Manual Itamar Medical Ltd Add Event Select Channel
60. d by Either clicking on the print icon el on the toolbar or selecting File gt Print User has a number of options for printing Figure 76 e Printing the entire study Printing the screen e Printing specific sections defined by time range e Printing specific channels Printer Name Status Type Adobe POF Converter Where Mu Documents Comment Print Range Options A Scale signals to fit vertically e Screen w Print events Time Print gridlines Sigg SR Channels w PAT w PAT Amplitude W PulseR ate w Sal2 w Actignaph w MII Stages w Body Position w Snore Cancel Figure 76 Print dialog box ZZZPAT 4 2 78 Operation Manual Itamar Medical Ltd 5 Exporting Data 5 1 File gt Export Data Enables the user to export and save recorded signals data either in binary or EDF format 5 2 File gt Export Events Creating txt File Enables the user to export marked events into ACSII format It creates an Event txt file that lists all events in a study by time of occurrence 5 3 Tools gt Export Delete See section 6 1 5 4 Tools gt Export General Settings See section 6 5 5 5 Transferring a Study to Itamar Medical Used to save a study in a ZIP file for transferring to Itamar Medical s support department If zzzPAT has Internet access this function allows the user to send the file directly without saving first Note The signals data that is transferred to Itamar does not include any pa
61. des automatically the following indices and events e Sleep wake events using the Automatic Sleep Wake Algorithm ASWA Respiratory events index which includes Apnea Hypopnea and RERA pRDI PAT Respiratory Disorders Index e Apnea and Hypopnea Index pAHI PAT Apnea and Hypopnea Index e Oxygen Desaturation Index ODI e REM REM events using the Automatic REM Detection Algorithm ARDA e Deep and Light Sleep s1 s2 is light and s3 s4 is Deep sleep Sleep Wake The sleep wake output obtained in 30 seconds epochs is used by the other three algorithms to apply calculations in sleep sections only while skipping over the wake sections pRDI and pAHI pRDI expresses the number of PAT respiratory events per hour of sleep the index includes the following events Apnea and Hypopnea and RERA respiratory effort related arousal pAHI expresses the number of Apnea and Hypopnea per hour of sleep These events are derived from the following physiological parameters measured by the WP 100 e PAT signal amplitude acquired by a pneumo optical finger probe that measures the vasomotor changes of the arterial blood vessels in the finger This reflects changes in sympathetic activity e Pulse rate derived from the above PAT signal e Blood Oxygen saturation level determined by an embedded pulse Oximeter The first two parameters are associated with sympathetic activity related to respiratory episodes The third parameter oxygen sa
62. e Import General Settings icon E e Refer to Section 6 6 for a detailed explanation of the general settings importing procedure ZZZPAT 4 2 96 Operation Manual Itamar Medical Ltd 8 Troubleshooting Installation Possible Cause Solution _ zzzPAT installer fails Open My Computer gt zzzPAT CD and to run Windows is not activated double click Setup exe Windows version not Must have Windows 2000 or Windows XP compatible with zzzPAT for zzzPAT installer to run Hardware configuration Must have at least 128 MB RAM and a Pentium processor for zZzPAT installer to run ZZZPAT fails to Compact Flash drive not Install Compact Flash drive when done recognize flash drive installed insert a CF card run zzzPAT and select Setup gt Set USB Drive see section Setup gt Set USB Drive Compact Flash drive Insert a CF card run zzzPAT and select needs to be re defined Setup gt Set USB Drive see section Setup gt Set USB Drive Under Windows XP User does not have Check user s writing permissions per user cannot load writing permission to the section and redefine as necessary study or operate drives these applications Database Wizard are located on utilities despite having proper ZZZPAT user permissions Table 2 Troubleshooting Installation zzzPAT Possible Cause Analyze gt Reload User does not have zzzPAT Administrator can modify user s Study and Analyze permission
63. e available to all users ZZZPAT 4 2 25 Operation Manual Itamar Medical Ltd General Settings Report Translation Clinical Diagnosis Clinical Recommendations HL Configuration Events Medical History Medications Custom Fields General Options Report 4ppearance Wake Wake Desaturation Desaturation Default Settings Push Button Push Button Excluded Excluded Resp Event Resp Event FEM FEM Sleep L Sleep L Sleep Sleep L Sleep Sleep e Display Long Name C Display Short Name Figure 27 General Settings Setting Dialog Box Events Tab When all settings changes are completed click OK to close the General Settings dialog box The following dialog box will open WW 7 77PAT Question i Are you sure you want to save the changes No Cancel Figure 28 Save settings question Clicking Yes will save the changes Clicking No will exit General Settings dialog box Clicking Cancel will return the last displayed dialog box 3 4 1 Setup gt General Settings gt Events A list of Event types is listed in the events tab Figure 27 The list includes event type long name short name and category for each event ZZZPAT 4 2 26 Operation Manual Itamar Medical Ltd To Modify an Event in the Settings list e Click on the Event in the list box The Modify and Default Setting buttons become enabled e Click the Modify button Modify Event Definition dialog opens e Enter th
64. e required names in the fields e Click OK to confirm and exit Default Settings reverts to the default event list Note Clicking the Default Settings will revert to default settings losing all user defined settings 3 4 2 Setup gt General Settings gt Medical History A preliminary list of medical condition descriptions is listed in the Medical History Tab Figure 29 General Settings Report 4ppearance Report Translation Clinical Diagnosis Clinical Recommendations Events Medical History Medications Custom Fields General Options ChronicAllergic rhiritis sinusitts Modify Congenital heart disease Congestive heart failure COPD Remove Coronary artery disease Deviated septum Diabetes Mellitus Epilepsy Esophageal reflux Default Settings Hyperlipidemia Hypertension Lu Hupertroohy m Add to Medical History Cancel Help Figure 29 General Settings Dialog Box Medical History Tab ZZZPAT 4 2 24 Operation Manual Itamar Medical Ltd To add a condition to the list e Type the condition in the Add to Medical History box The Add button becomes enabled e Click Add To modify a condition e Click on the condition e Click Modify The Modify dialog box opens with the selected condition name e Type in the desired changes To remove a condition from the list e Click on the condition e Click Remove e Click OK or Apply Default Settings reverts to the defa
65. e zzzPAT software WP200 device only Connect the device to the PC s USB drive using the supplied USB cable e Click File gt New Study Details in zzzPAT A dialog box will open see Figure 38 e Click Select USB Drive in the New Study dialog box The following window will appear Select USB Drive Select USB Drive Cancel Show All Drives Figure 17 Select USB Drive dialog box e The USB drive with the Compact Flash card WP200 device is identified by the ZZZPAT and is listed in this window Click OK to confirm the drive selection ZZZPAT 4 2 16 Operation Manual Itamar Medical Ltd 2 8 Opening an ftp reception account with Itamar Support Opening an ftp signal reception account at Itamar Support after installing zZZPAT will allow fast and efficient support if needed later To do so e Open a sample study e Follow the steps in section 5 5 2 9 Before using zzzPAT Software for the first time In order to maintain the security of the information stored by the zzzPAT it is recommended that you set new administration Login and Password replacing the default setting 2 9 1 Setting new login and Password for the zzzPAT Administrator e Select Tools gt User Administration from zzzPAT or navigate through Start gt Programs gt zzzPAT gt Database Wizard see 2 6 2 e Log in using the system default settings in Shared Access mode this process needs to be repeated twice once for the shared access database and
66. econd Date Tested W Reported w Archived ZZZPAT 4 2 49 Operation Manual Itamar Medical Ltd Figure 47 Select studies option Show section Each study is associated to one of the following statuses listed bellow Checking the boxes to the left of these statuses enables the user to define according to the following categories which of the studies from the zzzPAT database will be displayed on the Select Patient Study dialog box Unreviewed Study was loaded to zzzPAT and automatic analysis performed on it Reviewed User modified events entered Diagnosis or Recommendations saved study results or produced a sleep report Reported User selected the Set as Reported option in the Clinical Diagnosis dialog box This study cannot be modified and no additional information can be inserted into the report Archived Study was extracted and removed from the database to an archive out side the zzzPAT database These studies cannot be reviewed unless retrieved back into the database first Note The usual cycle of a study is Unreviewed gt Reviewed Reported Archived Sort Order section Enables the user to define the order by which the studies are displayed It is possible to display the studies by ID last name date of study date file loaded and additional user inserted criteria First order field Contains system predefined criteria and user defined criteria inserted in D
67. ect studies by a specific criterion check the box to the left of the desired criterion In addition user can select whether to export studies by status Un reviewed Reviewed and Reported and by user predefined Custom Fields see section 3 4 4 It is possible to select several criteria by which to export a single group of studies Note The Custom Fields section will appear in the Select Studies By dialog box only if the user predefined these fields See ZZZPAI 4 2 section 3 4 4 for details Select the studies you wish to export archive delete from the main field in the Export dialog box You can click Select All to select all files or you can select individual files by shift or control clicking on them Once ready click Start Export to export the selected studies or Start Archive to archive the selected studies or 86 Operation Manual Itamar Medical Ltd e Start Delete to delete the selected studies or e Export to CSV to export the selected studies to CSV format e Click Exit to close the Export dialog box e Export for Interpretation function Prepares and copies the raw data files as one zipped file for later ftp upload to a secure server for interpretation services 6 2 Tools gt Import Use to import previously archived studies that were removed from the zzzPAT database back into the database Upon selection the Import dialog box will open Note Together with the imported studies zzzPAT i
68. efine Study custom Field see 4 1 3 5 Second order field Contains only system predefined criteria 4 2 4 File gt Save Study Results Saves the patient study results events currently being viewed without closing zzzPAT and sets the study as reviewed This feature is important when Respiratory events are edited added or deleted and the new events need to be saved for future zzzPAT sessions 4 2 5 File gt Close Study Closes the patient study currently being viewed without closing zzzPAT 4 2 6 File gt Exit Closes both the patient study being viewed and the zzzPAT ZZZPAT 4 2 50 Operation Manual Itamar Medical Ltd 4 2 7 Edit gt Study Details Opens the View Study Details dialog box with current patient information This information can be edited by clicking the Edit button Authorization users can change the patient ID only once 4 3 The Display Screen The main screen displays the WP100 or WP200 recording waveforms with the events that were detected by the automatic analysis The traces are displayed synchronized to a uniform time base Display Area Marker Screen Header Time Base list Jh zzzPAT Smith John Sample Study Tested on 10 19 2006 Analysis cresited on 4 17 2008 4 28 13 PM by Super User Unreviewed E e File Edit view Events Paging Setup Analyze Report Tools Help e EFAA a BEE iT ian ia wi DEET All night Display Channel Title bar Se Ai 01 00 01 TITTEN Um wm Window
69. es 1 1 2 Phe 2220 Al S W Definitio E 1 1 3 CDV CF VICW ege 1 2 INSTALLATION EE 3 2 1 Overall Description Of ZZZPAT Softwar e cscsscccccrsssssssscccccccsccessssssccccssssesssssssscceooes 3 2 2 Hardware Reguirem nts cccsiscodssiccatscesssindsssveats aussibesensel dsewass gdeasuvetaseeasbbdaisessiseesissdesceeaasenuides 3 2 3 Installation of the Compact Flash drive cccsscccccsssssssssssscccccccssssssscccccssscesssssccccssseeeees 4 2 4 Installing 77Z7P AT Ste deene deeg ee 5 2 5 Step by step installation instructions ssssceccccossssseceoecocssssseceooossssececcsosssescecesossssssesessssssssee 6 2 6 Upgrading from previous EES geen geeege EES ENER EENEG 15 2T Dehinine he USB EE ee 16 2 8 Opening an ftp reception account with Itamar Support sssssccccoossssssecoccossssecceoossssssssee 17 2 9 Before using ZZZPAT Software for the first time ssecceooocssssesececocssssseccccosssssecceosssssssssee 17 A SETTING UP ZZZPAT CONFIGURATION ee REENEN ENEE REN RE RER EEN EE ER ER EN 21 3 1 Sep Se DT RE 21 3 2 Sep DIrCCIOTIC scone a scciscvocutaistacassiocoiienseserecaaceusuoesetacasnusdalsensecetasecdeasdenuetadaceeseanvenie s 21 3 3 eL E BEE i P A E T E T E E T 21 3 4 Semp General SELIM EE 25 A MUSING ZZ ZEA EE 37 4 1 Preparing a New te E 37 4 2 Manasina Patient Studies ssnin NAA 47 4 3 The Display SCKCOM EE 5I ZZZPAT 4 2 iv Operation Manual Itamar Medical Ltd 4 4 ISN al Display Options essciivc
70. g box cccsccseseeeseeeeeeeeeeneeeneeeneeeaeeeaeenseenseenseonseoneenneenaeeeneeenenenes 48 Figure 46 Select Patient Study dialog box cceecceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeseneseaeseneseneeenenenes 49 ZZZPAT 4 2 vii Operation Manual Itamar Medical Ltd Pigure 47 Select Studies opion Ce uisa a a th eeeeee eee oi i itech as 50 Figure 48 7770 AV enee 51 Figure 49 Selecting the All might Wmdow REENEN REENEN REENEN ENNER ENEE ENEE ENRER EEN ENN 52 Figure 50 All Night pop up MCU eegege gege Eege EE 53 Figure 51 Signal Properties All Night Wind Ow 2 c cceseseeeeeeeeeeeeeeeeeeeeseeeeeeeseeeeeeeeeeseeseeeeeeneees 53 Figure 52 All Night pop up menu de sandieeccesncasewcace yeni oue ane cave siaiebestaeececeu wins teelateteadene endian 54 Figure 53 Active channel pop up menu EEN ENEE RE EEN R EE EE REENEN ENEE ER ENEE EN 95 Fig r 54 77ZP AT screen Status Bar isordi eaa aae anarak aida aea D5 Figure 55 Set Channels View Dialog BOX ssssssssssnnsnnunnnnnnnnnnnnnnnnnnnnnnnnnnnnunnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnmnnn 56 Ficure 56 Sety Scale dialog POX isci rersstor asa aA aAA aaa of Figure 57 Set y Scale per channel dialog box ccccecceeeeeeeeeeeeeeeeeeeseeeeeeeeneeneseeseaeeeeseneeneaeesanens 97 Figure 58 Add Event dialog E 61 Figure 59 Event KE TE 62 Figure 60 Select Event dialog bag s 62 Figure 6 Editins sleep stad EE 63 Figure 62 Report VOOM Ar osisrenor sacs vised cathe t
71. ght studies are loaded automatically and the last loaded study will be displayed Use the Open Study dialog to open and review all the night studies ZZZPAT 4 2 48 Operation Manual Itamar Medical Ltd 4 2 3 File gt Open Study Opens studies stored in the zzzPAT database from previously loaded studies see Figure 46 Double click on a patient and the studies for that patient are listed with the date time of each study Double click the S study icon to load and display recorded information on the screen Select Patient Study Smith John 15012 Selected studies All sorted by Last Name and Date Tested Cancel Carry Man 15044 Tested on 01 23 2002 11 53 08 PH Loaded on 12 26 2002 11 25 16 AM unreviewed Select Studies EI Cone Ron 5087756 3 Tested on 06 11 2002 02 01 06 AM Loaded on 1272672002 11 29 09 4M reported B Rozen Sara 7144023 3 de Tested on 06 13 2002 12 33 37 AM Loaded on 12 26 2002 11 28 00 AM unreviewed BI Smith John 15012 d Tested on 03 14 2002 10 56 01 PM Loaded on 12 26 2002 11 26 50 AM reviewed Number of studies 4 Figure 46 Select Patient Study dialog box Select Studies button Enables the user to define select and organize the displayed studies in the Select Patient Study dialog box e Click Select Studies The following Dialog box will open select Studies Options Sh Sort Ord ow ort Order op 2 Mw Unreviewed First Last Name Cancel Mw Reviewed S
72. his 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 23 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 i with the Licensed Product s and ii in accordance with the 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 exce
73. ical Ltd 3 4 4 Setup gt General Settings gt Custom Fields Up to three Custom Fields can be defined and named by the user These Custom Fields can be used to organize your studies in the Select Patient Study dialog box Figure 46 and during the Export Import process These custom fields are available to all users General Settings Report 4ppearance Report Translation Clinical Diagnosis Clinical Recommendations Events Medical History Medications Custom Fields General Options M Use Custom Field 1 Named As Field M Use Custom Field 2 Named As Pei Values Use Custom Field 3 Named As eld Male Figure 31 General Settings Dialog Box Custom Fields Tab To enable a custom field e Check the box to the left of the custom field The Values button becomes enabled e Write the title of your choice for this field in the text box for example CHF e Click the Values button the following dialog box will open ZZZPAT 4 2 30 Operation Manual Itamar Medical Ltd Define Values List E Values For CHF oe List of Values ok FC nen Value to Add Fo KE Add gt FCS ECH Clear List Figure 32 Define Values List Dialog box To insert a value into the List of Values field e Write a value you wish to insert into the Value to add text box the Add and Remove buttons will become enabled e Click Add To delete a value from the list of values you created e Cl
74. ick on the value and click Remove e Click OK to save settings Note Defining values can assist you when entering the information into these fields while preparing a New Study but you can also type free text values into these fields 3 4 55 Setup gt General Settings gt General Options Used to set up reminders to backup the database alerts when available disk space is below 1GB and in order to enable features that not enabled by default import packed studies multi night studies and tamper proof testing ZZZPAT 4 2 31 Operation Manual Itamar Medical Ltd General Settings Report Translation Clinical Diagnosis Clinical Recommendations HL Configuration Events Medical History Medications Custom Fields General Options Report Appearance Snoring Threshold 40 dE w Prompt for backup every 30 Enable Packed Studies Import Enable Tarmper Proof Testing option Enable Multiple Nights option up to 3 nights Label Printer Print label during New Study Printers Number of labels H Cancel Help Figure 33 General Settings Dialog Box General Options Tab e Select snoring threshold to be used in calculating snoring statistics 3 page of report used only in non USA version e Check Prompt for backup every and set the numbers of days to get a reminder message after the last backup of the database was performed e Check Prompt for archive when disk space
75. ing on them with the mouse while holding down the Ctrl key on the keyboard or you can import them all by clicking on the Select All button e Click Start Import to begin the process Note You cannot import a study that is already available in the database 6 3 Tools gt Backup Enables the user to copy the entire database to another location for back up Upon selection the Backup dialog box will open e Select the path for a backup directory by clicking on the Browse button or by accepting the system default setting e Click Start Backup to begin the process Automatic Backup A backup of the database for every day of the week will be automatically performed behind the scenes Backing this way will minimize loss of data in case of database corruption The backup of the database will be saved as zzPATday1 bak for Sunday zzPATday2 bak for Monday etc The zzPATday1 bak will be overwritten next Sunday The files will be saved under backup folder C itamar medical zzzpat backup 6 4 Tools gt Restore Use this application for restoring a backed up database by overwriting the current database Use this application to recover a database following a major database failure Upon selection the Restore dialog box will open Restore Restore Folder Care medicalzzzpat database Backup Use Restore to owerwnte the current database with an old copy Start Restore The curent data will be LOST DB Connection Local Figure
76. ional data such as device etc The labels may be attached to WP100 or WP200 suitcases as to provide easy identification of the designated patient after the WP100 or WP200 devices have been initialized with the patient details 1D 0123456 78901234 Nametohnn Smith Date 14 12 05 1 Figure 34 Label example Note Contact Itamar Medical for a list of the supported label printers ZZZPAI 4 2 33 Operation Manual Itamar Medical Ltd 3 4 6 Setup gt General Settings gt Report Appearance Used to change the basic Report appearance adding a logo affiliation header and footer General Settings Everts Medical History Medications Custom Fields General Options Report Appearance Report Translation Clinical Diagnosis Clinical Recommendations Logo Set Logo Headers and Footer Headers Footer Curent Logo C One page Sleep Report results only e Two pages Sleep Report 2 first pagest pan evi nie ca E E C Three pages Sleep Report all 3 pages Figure 35 General Settings Dialog Box Report Appearance Tab To add a logo to the sleep report e Click the Set Logo to browse for the desired logo file File may be in bitmap BMP extension or JPEG JPG or JPEG extensions formats Highlight the logo file and click Open to add the icon Note that actual Icon size in the report does not exceed 140X100 pixels therefore larger images will be resized for proper printing e To
77. ions of the database Once an upgrade to a Shared Access installation zzzPAT station is made both the local and shared access databases must be updated to the correct version before the zzzPAT can be put to use again Before upgrading from a previous version of the zzzPAT the older version must be uninstalled The zzzPAT installer will identify if the older version has not been removed and will prompt you to uninstall Note Uninstalling zzzPAT does not remove the zzzPAT database however it is strongly recommended to backup the database before upgrading zzzPAT ZZZPAT 4 2 15 Operation Manual Itamar Medical Ltd e Backup the entire database of the existing zzzPAT installation see Database Wizard Backup section 7 1 3 e Select Setup exe from the zzzPAT installation CD ROM to start the zzzPAT installation program e Uninstall the previous zzZPAT version using Add Remove Programs applet from the control panel e Follow stages 1 5 in section 2 5 2 6 2 1 Upgrading Databases The upgrade will be performed automatically the first time zzzPAT is launched following an upgrade of zzzPAT only if the database folder remained the same as the previous installation 2 7 Defining the USB drive TO prepare a new study File gt New Study Details from zzzPAT you must first define the USB drive WP100 device only Place the Compact Flash card supplied with the WP100 in the USB drive that is connected to the PC with th
78. ired between several PCs When multiple PC s need fo access a central Ad d Client 5 Advanced Client Server ess DAT database over the network selected only once PRIOR fo installing the O Shared database Server SE Gei Shared database Client Repeated for all clients With Local database Buables fo work offline using a local database i Cancel Figure 12 Database Properties Advanced Client dialog box The Client installation may also have a local database and during zzzPAT login the user can select to connect to the Shared or Local database For this option you should check the With Local database check box It is not recommended to install the local database option unless offline work is anticipated with the particular computer Press Next to define the Shared Database GG zzzPAT InstallShield Wizard Shared Database Destination Define the shared database server Click Browse to see the available servers or click next to continue the installation Database server that you are installing to EEN Figure 13 Shared Database server dialog box ZZZPAT 4 2 12 Operation Manual Itamar Medical Ltd You can also enter the lt name of the computer with the SQL server gt ZZZSQL i e SQL _PC ZZZSQL The zzzPAT installer will identify and display the currently defined database servers Click Browse to see the ZZZSQL servers The shared MS SQL database can be selected from the list i
79. istanistanlotetantisaeevetenterieetecese eee 63 Figure 63 Clinical Diagnosis dialog box cescceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeaeeeeseneeeneseneseneseneseaeeeneeenes 64 Figure 64 New Analysis Warning MeSSage cecceseeceeceeeeeceeeeeeeeeeseeeeeeeeeeseeeeeaeeesseeeeeeeseeseeeeeensees 65 Figure 65 Snoring and Body Position Statistics ccccceeceeeeeeeeeeeeeeeeeeseeeeeeeeeeeeeeneseneseneseneaenenenes 66 Figure 66 gt First page of Sleep Report viscc decir cedintccaeceacsecneitaaieDetecacieteearie cece aa aaa aaa Eaa 67 Figure 67 Second page of Sleep KEREN ee EE REESEN 68 Figure 68 Third page of Sleep Report USA version c scccseceseeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeseneeeneneaes 69 Figure 69 Third page of Sleep Report non USA version s snsnanunnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nn 70 Figure 70 Sleep Report for Selected Time Range Title REENEN ERR EREER KEREN ENNER ENNER E EEN 71 Figure Tis Event Rep lt a E 72 Figure 72 Detailed Event REM GE 73 Pigure 7 3 Sleep Indices Pep Or scisec ee deeg eege Eege dee ees 73 Figure 74 Patient Follow Up Report USA Version EE EREE RENE ERKENNEN ENEE EN 75 Fioure 75 Wetter tothe att 77 Figure 76 Print ial WX rci tuanaotnnasvannd vas esas aatccaxw peenauaandaaoeseaseeevesstacenatunns 78 Figure 77 Launching Transfer Files ccscciscncsacascadeeceicasshidessverese tase sinccaneceecevcnseecahmecvensnescapesceserweiss 80 Figure 78 Prepare and Send Study Dia
80. l channels to the same size The Attached Channel for General Events section is used to set the channel on which the general events are displayed General events are events generated by the automatic analysis of the zzzPAT 4 4 2 View gt Set y Scale Opens the Set y Scale dialog box ZZZPAT 4 2 56 Operation Manual Itamar Medical Ltd set y Scale i All Night WP100 Stages Coe Winiar Maxinoiuim 1 F 0 Amplitude Change SS PAT 10018 11515 PAT Amplitude eed rroa Salz Jz 100 Actigraph WER 2643 WPTOO Stages 12 10 Figure 56 Set y Scale dialog box The All Night section allows editing the y scale for the All Night channel To edit the y Scale of all other channels e Mark the channel on the Set y Scale dialog box e Click Modify The following dialog box will open set y Scale DAT Minimum Mazimum Amplitude Change E Ignore Et to Window Model Figure 57 Set y Scale per channel dialog box e Select minimum maximum ranges for the y Scale or control the channels gain with E e Define whether to ignore Fit to Window Mode See section 4 4 6 To edit the y Scale using the zzzPAT screen e Activate a channel by clicking anywhere on it e Click on the Ea Ea buttons at the bottom of the channels Title Bar To raise or lower the range scale of a channel e Left click on the channel title bar and drag the scale range numbers ZZZPAT 4 2 5
81. log BOX REENEN REEREEREE REENEN REENEN ENEE E RER 80 Figure 79 Sayma Case A E 81 Figure 80 Sending Study Confirmation sssssssssssnsnnsnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnmnnn 82 Figure 81e Data Transfer e ciccuscnsiessiaasvodentaasaanncdnesevesacsinasincasusadteceeisnecssccoddvenscbeessseannounes 82 Figure 82 Data Transfer Successfully Completed cccecceeeeeeeeeeeeeseeeeeeeeeeeeeeeeeeneseneseneseneneaes 83 Fig r 83 Export Dial0s DOX s koa ege 84 Figure 84 Delete studies options Dialog box NEEN REENEN REENEN ENNER REENEN RENE REENEN RENE 85 Figure 85 Study Selection Dialog box cscccsesseesseeeeneenecseeeneonesenesensonseonsenneenseenneenneenaeseneoenss 86 Figure 60 Import Dialog gege ege SEENEN 87 Figure 87 Select Archive Dialog Meester ege eech 88 Fisure 88 Restore Fees 89 Figure 89 Export General Settings Dialog Box REENEN EREEREEREE REENEN ENNER ENEE E EE 90 Figure 90 Import General Settings Dialog BOX REENEN REEREEREE REENEN REENEN ENEE E RER 91 Figure 91 Database Wizard KEEN Seege Gd ege 92 Figure 92 Database WIZAGG sieieusicioes saat eat a aicaaioeetboceectecitacesueeeree sede Ge tieeene ies 93 Figure 93 Database Tools Wizard dialog DOX c ccceeceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeesenesenesenesenesenenenes 94 Figure 94 Configuration Tool Wizard sinsccsscicccetesdeistanscvcatcvcsviessnavicsdandesdieneidectiocseastentvasiescdeaneaxt 95 ZZZPAT 4 2 viii Operation Man
82. low fhe steps Create a Shared folder for fhe shared database e g MdyShare Grant Full Control permissions fo fhe folder for Everyone local and network Use fhe Change Suffon fo select if feo Werrer Mame Wd ohare Figure 11 Shared Database dialog box Press the Change button to enter a UNC path for the database files folder This folder will be accessed by all zzzPAT users so it needs to be shared in the network with full control permissions for the Everyone group Note If you do not want to use the Everyone group please define a group of zzzPAT users and grant this group Full Access to this shared folder In that case you will have to grant the same permissions to the following services SQL Server ZZZSQL SQL Server VSS WRITER The last dialog prior to beginning server installation summarizes your selections After reading this summary press Install to begin the installation 2 5 1 3 Advanced Client installation only The following selection will result in Client installation Prior to performing a Client side installation a Shared Database installation must be previously performed on a given PC ZZZPAT 4 2 11 Operation Manual Itamar Medical Ltd i zzzPAt InstallShield Wizard Database Properties Select database properties IF you select to Install the shared database Client you must ensure that a server is already installed Standard Standalone When no sharing of fhe data is requ
83. mports user information of users associated with the imported files if such users are not defined in zzzPAT These users are imported with Basic User Permissions only see Section 2 9 2 Import From M Folder E e EENEG e Old Archives Logged in Database Archives Logged in Database Selected path C V tamar Mechcalhzzab lV glsbaee v chtoe zz CHIVE_09 Oct 05_1 No Studies Selected exported studies First Mame SAMPLE STUD SAMPLE SAMPLE STUD SAMPLE 2 selected out of 2 total studies DB Connection Local Created by Load Date 09 Jan 03 09 Jan 03 Last Name Study Date STUDY 23 May 01 STUDY 15 5ep 01 Reviewed Reviewed 20567 KB out of 20567 KB total hone Figure 86 Import Dialog Box Archive Selection Select All Unselect All Start Import Exit It is possible to locate the archived studies you wish to import by using the Browse option or by selecting them from a list of logged archives in the database If previously deleted files were deleted using the Save a temporary copy option selecting the Last Deleted Studies option will allow retrieval of these studies ZZZPAI 4 2 87 Operation Manual Itamar Medical Ltd Locating an Archive by browsing e Select the Folder radio button in the Import dialog box The Browse button will become enabled e Click on the Browse button and select the file you wish to import Locating an Archive from
84. n Password 000 o Cancel DB Connection local Figure 37 Login Dialog Box e Enter Login and Password When a Shared Access mode is installed the login screen allows the user to choose to which database the zzzPAT will connect ZZZPAT 4 2 37 Operation Manual Itamar Medical Ltd Note In Shared Access mode it is highly recommended to always connect to the Shared database this will ensure all data is stored in one central location allowing future retrieval from all connected stations Local database should be selected only if network access is not available or for special purposes training travel etc Note In Shared Access mode if data was stored on the local database it is recommended to export the data into the Shared Access database as soon as practical e lf applicable select the desired database to connect to Local database should be selected only if network access is not available or for special purposes training travel etc e Enter your login name and password and click OK to continue 4 1 2 Preparing a New Study For WP100 only e Make sure a Compact Flash card is in the Compact Flash reader and connected to the PC with the zzzPAT software e Click File gt New Study Details in zzzPAT or click the New Study icon S the tool bar e The New Study dialog box appears ZZZPAT 4 2 38 Operation Manual Itamar Medical Ltd C Mew Study Patient Save To USB ID
85. n com H Program Files i temp iy WINDOWS See DATA Ds K Figure 7 Choose folder dialog box Make sure you are not selecting a mapped drive Select OK to Proceed The zzzPAT Installer will assist in selecting a destination location for the zzzPAT application files If you wish to change the default folder select the Change button i zzzPAt InstallShield Wizard Application Folder Click Next to install to this Folder or click Change to install to a different Folder Install 222P 4T bo Program Files Ikanar medicallz22P4T This folder will hold all me PAT components programs utilities help files efte Figure 8 Application folder dialog box The last dialog before standalone installations summarizes your selections After reading this summary press Install to begin the installation ZZZPAI 4 2 Operation Manual Itamar Medical Ltd i zzzPAt InstallShield Wizard Ready to Install the Program The wizard is ready to begin installation Click Install to begin the installation TF you want to review or change any of your installation settings click Back Click Cancel to exit the wizard Tou have chosen a Sfandalone installation Tow have chosen fo install fhe ge PAT Program af C Program Piles itamar medical ess PAT t Tou have selected fo use fhe Wiamar medical zegpatidatabase folder for your data files Au ACL Express 2005 stance 22200 WILL BE INSTALLED on your com
86. nded to disable the Fit to Window Mode on the actigraphy channel For instructions see section 4 4 2 4 4 7 View gt Grid On Off Displays the grid lines of the channel values User may enable or disable the Grid On Off feature for a specific channel by right clicking the mouse on the highlighted channel 4 4 88 View gt Relative Time Choosing this option or clicking on zzzPAT toolbar toggles the time mode of the study being viewed between Absolute Time mode and Relative Time mode In Relative Time mode the beginning of the study is always defined as 00 00 00 on the x scale of the zzzPAT screen and the time is measured from the beginning of the study ZZZPAT 4 2 58 Operation Manual Itamar Medical Ltd In Absolute Time mode the absolute time appears on the x scale of the zzzPAT screen i e the time registered by the WP100 or WP200 device 4 4 9 View gt Zoom In To enable this option highlight a section of the waveform by clicking and dragging the mouse The option View gt Zoom In and the corresponding toolbar button Dh become enabled Activating the Zoom In option modifies the Time Base to fit the highlighted segment into the entire width of the Signals Display Window Note that the Time Base window and the Status bar details are updated automatically When the time base is one second the zoom in option is disabled 4 4 10 View gt Zoom Out View gt Zoom Out and corresponding toolbar button E are enabled when the cu
87. ndow o Check Send Study From USB if the case study is stored in the Compact Flash card WP100 or in the WP200 o Check Send WP200 Device Logs in case the internal logs from the ZZZPAT 4 2 80 Operation Manual Itamar Medical Ltd WP200 device needs to be sent to Itamar for troubleshooting e To save the study click Save The following dialog box appears Browse for Folder Save zz7PAT Packed Data As My Computer DI ze SYSTEM C fa DVD Drive D ES a home on HOME SVR Samba Server home ES 3 My Network Places Share to Web Upload Folder H E Cancel Figure 79 Saving Case Study e Select the destination for the saved file The file will have the following name o zzzPATPack_DI zzp Where o D isthe current date o T isthe current time 5 5 1 Sending a file to Itamar automatically To transfer the study to Itamar Medical s support department e From zzzPAT click Help gt Prepare and Send Study to Itamar Medical e Fill in the mandatory fields and check the radio button to indicate the desired option o Check Send Current Opened Study if the case study is currently displayed on the Signal Window o Check Send Study From USB if the case study is stored in the Compact Flash card e Click Send The following screen appears ZZZPAT 4 2 81 Operation Manual Itamar Medical Ltd W 77PAT Information You can Find this information in C Program Files iIkamar medicallzz2P4T DatalsystemIinfo txt Do vou
88. nt Type Search options 4 5 9 Events gt Select Event Select Event Event Type Selected E vents Desaturation Excluded Figure 60 Select Event dialog box Enables the user to select a specific event for viewing All existing events are listed by type and start time User may select a specific event by clicking on it The Selected ZZZPAT 4 2 62 Operation Manual Itamar Medical Ltd Events field in the Select Event window is updated to display the page with the specific event 4 5 10 Editing Sleep Stages You are able to manually edit the Sleep stages if you already selected to enable this option see Setup gt General Settings gt General Options In order to edit the sleep stages right click the mouse while on top of the sleep stage and then select a new sleep stage from the Replace with menu see Figure 61 D Sleep REM Excluded t Figure 61 Editing sleep stages 4 6 Reports All reports can be reviewed on screen and printed The toolbar in report view mode includes the following items de g vi TE MECH Figure 62 Report Toolbar e To print a report click on the printer icon e To export a report to a different format such as pdf rtf html etc select the export icon oP e User can see how many pages there are in a report and choose which page to view by using the pee icons 4 6 1 Report gt Clinical Diagnosis Allows adding a diagnosis and recommendations to the Sleep Report screen see
89. oftware for the first time ZZZPAT 4 2 5 Operation Manual Itamar Medical Ltd 2 5 Step by step installation instructions Prior to installation verify that you are in full system administrator mode with full privileges l Zi Insert the zzzPAT installation CD into the CD drive The installation program is activated and the following dialog box appears If the installation does not start automatically refer to section 2 4 i zzzPAt InstallShield Wizard Welcome to the InstallShield Wizard for tamar The InstallShield Fi Wizard will install zzzPAT on your computer To continue click Mest WARMING This program is protected by copyright law and international treaties Figure 2 zzzPAT installation dialog box Click Next The License Agreement appears ie zzzPAT InstallShield Wizard License Agreement Please read the Following license agreement carefully 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 bh ALL LICENSED PRODUCTS 45 DEFINED BELOW AND ech ALL THIRD PARTY PRODUCTS INTO WHICH 4 LICENSED PRODUCT OR LICENSED I do not accept the terms in the license agreement Figure 3 zzzPAT License Agreement ZZZPAT 4 2 6 Operation M
90. oice 4 1 3 1 Synchronizing the WP100 device clock with the zzzPAT software The internal clock of the WP100 device needs to be set correctly in order for the Study Date Time to appear correctly after loading a study in zzzPAT Since zZZPAT version 3 0 all WP100 devices are delivered from Itamar Medical having the internal clock set to GMT Greenwich Mean Time The Time Zone field in New Study screen contains the offset in hours that is added or subtracted to the Study Date Time read from the WP100 device e lf the WP100 device clock is set to GMT this offset equals to the difference in hours between the computer s local time and GMT e If the WP100 device clock is set to local time this offset equals to zero select GMT on the pull down menu To adjust for daylight savings or if you notice a discrepancy in hours between the actual Study Date Time and the one obtained in zzzPAT you can change the Time Zone field in New Study screen in order to compensate for the discrepancy e If zzzPAT date time is later than the actual Study Date Time decrease the Time Zone ZZZPAT 4 2 42 Operation Manual Itamar Medical Ltd e If zzzPAT date time is earlier than the actual Study Date Time increase the Time Zone Note You do not need to set the Time Zone field each time you prepare a New Study The software remembers the last Time Zone used Note The local GMT offset can be found in Start
91. ompact Flash patient dat and sleep dat from Program not recognize the card Files ltamar Medical zzzPAT Misc to the Compact Flash card Compact Flash card and try again Compact Flash card was Reformatted Compact Flash cards cannot formatted to an be used with the Watch PAT system and unsupported format have to be replaced WP200 only New Critical files were erased Format drive with volume name WP200 Study or zzzPAT do from the internal sd card and then copy files patient dat sleep dat not recognize the or the volume name has and wp200 comm dat from Program WP200 been erased Files ltamar Medical zzzPAT Misc to the WP200 drive Database Tools User does not have zzzPAT Administrator can modify users button in the permission to operate Extended Permissions See section 2 9 Database Wizard this utility window or Tools in ZZZPAT is disabled User Administration User does not have zzzPAT Administrator can modify user s button in the permission to operate Extended Permissions See section2 9 Database Wizard this utility window or Tools gt User Administration is disabled does not open running Database tools Et ll O O ee his password Table 5 Troubleshooting Utilities ZZZPAT 4 2 100 Operation Manual Itamar Medical Ltd Appendix A LICENSE AGREEMENT License To User From Itamar IMPORTANT PLEASE READ THIS LICENSE AGREEMENT CAREFULLY BEFORE INSTALLING OR OTHERWISE USING THE LICENSED SOFTWARE AS DEFINED BEL
92. on User cannot log on In Shared Access mode Define user in the second database or to zzzPAT user may be defined in Exit zzzZPAT and log on to the other the shared database and zzzPAT database either local or shared not in the local one or vice versa Cannot find saved File saved to the other Verify to which database zzzPAT is file database either the local connected the database or shared database connection appears in the zzzPAT status bar Exit zZZPAT Start zzzPAT and select the other database to connect to Select File gt Open and search for the desired file Shared database is Network is disconnected Make sure the zzzPAT station is not available properly connected to the network and that network services are available to it Consult your system administrator if necessary Cannot open Study is in use by e Wait until the other user closes the selected study another zzzPAT user study and try again Table 4 Troubleshooting Shared Access Mode zzzPAT ZZZPAT 4 2 99 Operation Manual Itamar Medical Ltd Utilities Possible Cause Solution Preparing Compact Compact Flash card was Do not remove Compact Flash card from Flash card for new removed from the the Compact Flash reader before Figure 41 study failed Compact Flash reader dialog box appears before New Study details were saved to it WP100 only New Critical files were erased Using Windows Explorer copy files Study or zzzPAT do from the C
93. on The Snore Body Position data is displayed in a chart as shown here Figure 65 Snoring and Body Position Statistics Note Several additional parameters such as Sleep Latency REM Latency Number of wakes and Sleep Efficiency are calculated but are only seen when using the Export to csv function see Tools gt Export Delete ZZZPAT 4 2 66 Operation Manual Itamar Medical Ltd THIS LINE IS FOR ADDRESS AND AFFILIATION THIS PLACE I5 FOR THE THIS LINE IS FOR ADDRESS AND AFFILIATION PRACTICE LOGO Sleep Study Report Patient Information First Name John Last Mame Doe ID 000 00 0000 Birth Date 1071071953 AQe 52 Gender hale Insurer Bh Meck Circ Epworth Address Sleep Study Information Study Date 2 7 2005 SHA Version 3 049 191 8740 Referring Physician Information First Marne John Last Mame Doe E mail Work Phone 415 4827 98645 Mobile Phone Fax Medical information Medical History Asthma ChronivAllergic rhinitis sinusitis Medicatons Inhaled Beta agonist Masal decongestants summary amp Diagnosis Mild Sleep Apnea Physician Name Signature Date 272005 SAMPLE STUD SAMPLE STUDY Page 1 of 2 Printed on DI 72008 THIS UNE IS FOR ADDRESS AND AFFILIATION Figure 66 First page of Sleep Report ZZZPAT 4 2 67 Operation Manual Itamar Medical Ltd Sleep Study Report ell pal AU i ily ci lal onl d Sleep Summary Oxygen Saturation Statistics Start Study Time 05 40 4
94. once for the local database e Login 111 e Password 111 e A dialog box will open Figure 18 for Start gt Programs gt zzzPAT gt Database Wizard or Figure 19 for Tools gt User Administration TE 3277PA1 Database Wizard Database Tools User Administration Configuration Tools DB Connector Local Figure 18 zzzPAT database Wizard dialog box ZZZPAT 4 2 17 Operation Manual Itamar Medical Ltd Leem y e Click User Administration icon The User Administration dialog box will open Select Super User Click Edit User Change the default Login from 111 to the new login Change the default Password from 111 to a new password Update the personal information Click Save User Note In Shared Access mode changing the administrator login for the shared access database needs to be performed only once Changes to the local database administrator login needs to be changed in each of the zzzPAT stations 2 9 2 Setting a New user Setting new user Login and Password and defining the permissions allowed for each user operating the zzzPAT tar CH ZS see e Launch the Database Wizard and Click User Administration icon Section 2 9 1 or select Tools gt User Administration from zzzPAT e The following dialog box will open User Administration All Users FirstName LastName 8 Login Title Status User Achyve Stoken Active PE er RUE ise Add User
95. ons Tab REER ENNER ENNER EEN EEE En 29 Figure 31 General Settings Dialog Box Custom Fields Tab EEN ERRER ENNEN REENEN ENNER 30 Figure 32 Define Values List Dialog ug Gegegegeeg ge gggeege ees eseu ege EE EE dee 31 Figure 33 General Settings Dialog Box General Options Tab ccccceeseeeeeeeeeeeeeeeeneeeeeeeeenenenes 32 Figure 34 Er 33 Figure 35 General Settings Dialog Box Report Appearance Tab cccccceeeeeeeeeeeeeeeeeeeeenenenenenes 34 Figure 36 General Settings Dialog Box Report Translation Tab ccecceseeseeeeeeeeeeeeeeeeeeeeees 35 Figure 37 Logm Dialog eege Seeerei 37 Figure 38 New Study Dialog Box for WP100 ee REENEN RREREEREE REENEN REENEN RER ENEE E EE 39 Figure 39 New Study Dialog Box for WP200 ceccceeceeeeeeeeeeeeeeneeeeeeeeeeeeeeeseeeeseneseneseneseneeenennaes 40 Figure 40 Compact Flash Card WP200 Not Loaded Dialog BOX ccceccceeeeeeeeeeeeeeeneeeeeneeeneneees 41 Figure 41 New Study Termination Question cccccceeccseeeeeeeeeeeeeeeeeeeeseeeeeeeeeeneseneeeaeeeneeeneeenenenes 42 Figure 42 Demographic Details Dialog DOX cceccceeeeeeeeeeeeeeeeeeeeeeeeeseeeeeeeeeeeeseneseneseneseaeseneneaes 44 Figure 43 Patient Clinical Data Dialog box REENEN NENNEN REENEN ENNER ee REENEN RENE REENEN RENE 45 Figure 44 More Study Details Dialog box eccceeeeeeeeeeeeeeeeeeeeeeeeeaeeeeeeeeeeeeseneseaeseaeseneseneaenennes 46 Figure 45 Loading Study dialo
96. ons provided by the WP100 or WP200 systems are intended as an aid for Sleep Breathing Disorders diagnosis They are explicitly not to be regarded as a sole incontrovertible basis for clinical diagnosis e The zzzPAT software should be used only on compatible computers that meet the requirements specified in this document e Running other programs commercial or customized simultaneously with the ZZZPAT may interfere with its proper function e zzzPAT may not function properly under Windows XP when multiple sessions are running i e when more than one user is logged on to the same PC simultaneously and each user is running ZZZPAT e zzzPAT is not supported on Windows XP in remote mode ZZZPAT 4 2 2 Operation Manual Itamar Medical Ltd 2 Installation 2 1 Overall Description of zzzPAT Software ZZZPAT is a proprietary PC software developed specifically for managing and analyzing data recorded by the WP100 and WP200 devices The software displays and stores the recorded signals and provides a set of analytical functions for interpretation purposes A Compact Flash reader drive is used to read the data recorded by the WP100 on a Compact Flash card Please refer to Section 2 2 for required PC configuration A USB cable is used to read the data recorded by the WP200 on the internal SD card The ZzzPAT S W automatically detects the data on the internal SD card once the WP200 is connected to the PC via the USB communication cable ZZZPAT
97. peration Manual Itamar Medical Ltd 4 6 6 Report gt Patient Follow up Report This report provides a way of comparing multiple studies for the same patient A graphical representation of the pRDI pAHI and ODI for the different studies provides a quick way of determining a trend through the studies In the European version of the report the Sleep over 50 dB will be displayed as well Note Unreviewed studies will not be presented in the Patient follow up report see section 4 6 1 ZZZPAT 4 2 74 Operation Manual Itamar Medical Ltd Patient Follow Up Report Patient ID wphlo4 Patient Name John Smith Birth Date Gender Male Address 45 4 E 45 35 lt 4 30 4 35 25 d 30 70 15 d 20 O 18A 420085 Study Study Date Study Study Date Ref Physician pRDI pAHI ODI 1 01 Aug 2006 Mark Davis 43 6 43 4 36 0 Diagnosis Severe Sleep Apnea 2 02 Nov 2006 Mark Davis 23 1 23 1 16 4 Diagnosis Moderate Obstructive Sleep Apnea Total Number of Studies 2 Smith John wpaid4 Printed on 11 27 2006 10 21 444M Page 1 of 1 Figure 74 Patient Follow Up Report USA version ZZZPAT 4 2 75 Operation Manual Itamar Medical Ltd 4 6 7 Report gt Report for Patient This report is designed in the form of a letter addressed to the patient that informs the patient about the sleep test results It provides the following patient details e Total sleep time e Apnea Hypopnoea index AHI e Respiratory disturbance
98. pt 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 otherwise trademarks of Itamar No right license or interest to such trademarks are generated or granted hereunder other than the limited right to use provided herein and you agree that no such right license or interest shall be asserted by you with respect to such trademarks You may not remove or destroy any copyright trademark logo or other proprietary marking or legend placed on or contained in the Licensed Software or a Licensed Product ZZZPAT 4 2 102 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
99. puter Ta Figure 9 Ready to Install dialog box 2 5 1 2 Advanced Server installation only The following selection will result in Server installation The Server side installation creates a shared MS SQL database that is used by multiple ZZZPAT stations Accordingly the shared database needs to be created only once per site installation i zzzPAt InstallShield Wizard Database Properties Select database properties IF you select to Install the shared database Client vou must ensure that a server is already installed Standard Standalone When no sharing of fhe data is required between several PCs When multiple PC s need fo access a central azz AT database over fhe network selected only once PRIOR fo installing the Shared database Server SE Shared database Client Repeated for all clients Enables fo work offline using a local database Figure 10 Database Properties with Advanced options dialog box The zzzPAT Installer will assist in selecting a destination location for the zzzPAT database ZZZPAT 4 2 10 Operation Manual Itamar Medical Ltd i zzzPAt InstallShield Wizard Shared Database Destination Define the location For the shared database Click next to continue installation or click change bo change the folder Install zzzFAT shared database to 4dd Firewall exceptions For the SOL server Cotherwise you must add ther later Bee you select a folder make sure pou fol
100. rrent view is zoomed in Activating this option returns the view back to the previous zoom magnitude 4 4 11 View gt Zoom Original View gt Zoom Original and corresponding toolbar button are enabled when current view is zoomed in This option returns the view back to the original time scale 4 4 12 View gt All Night Window Enable disable the All Night Window See section 4 3 1 4 5 Review Analysis and Report Study 4 5 1 Data Analysis The zzzPAT software performs an automated analysis of the WP100 or WP200 recorded Signals providing extensive information on the patient s sleep The analysis provides an evaluation of respiratory events during sleep oxygen saturation statistics and REM sleep Statistics 4 5 1 1 Generating an Analysis Recorded study data is automatically analyzed after being loaded from the Compact Flash card You can also execute automatic data analysis by clicking Analyze gt Reload study and analyze This function reloads the saved study data and executes the automatic analysis If the user changed the file adding deleting modifying events these changes will be erased and will not impact the analysis ZZZPAT 4 2 59 Operation Manual Itamar Medical Ltd When used on a file that was previously analyzed and saved with an older version of zzzZPAT this function creates a new analysis using the current version of the zzzPAT software 4 5 1 2 REM Analysis REM analysis is part of the automatic analysis describe
101. rst DB Connection Shared Figure 39 New Study Dialog Box for WP200 e Fill the mandatory Patient ID in the Patient fields e Insert any additional information if needed the rest of the fields are optional e Select Study with Tamper Proof Testing if you want to use the Patient Identification Bracelet By enabling this option you can use the bracelet in order to verify that the identified patient is indeed the one sleeping with the device see Tamper Proof testing in Watch PAT200 Operation Manual This option is shown only if the feature is enabled in Setup gt General Settings gt General Options e Select Multiple Nights option in order to run up to 3 nights with the same WP200 device see Multi night study in Watch PAT200 Operation Manual This option is shown only if the feature is enabled in Setup gt General Settings gt General Options 40 Operation Manual Itamar Medical Ltd e Click the Save to USB button Note If the Patient ID field was left unfilled a message will be displayed requesting the need to be filled Fill in the missing information and press the Save to USB button again Note The units used for weight and height in the New Study dialog box are defined by the regional settings of the PC Note The Epworth Score is used to determine the level of daytime sleepiness An Epworth Sleepiness Scale Questionnaire can be found in the Misc folder under the zzzPAT Installation folder the default is
102. se in a standalone installation or the shared access database in a Shared Access installation ZZZPAT 4 2 21 Operation Manual Itamar Medical Ltd Note In a Shared Access mode when a user logs in from several ZZZPAT stations simultaneously changes to some of the user configurable settings of zzzPAT may not be saved after the ZZZPAT session ends When all settings changes are completed click OK to close the Settings dialog box The following dialog box will open WW 77PAT Question e boi el Are you sure you want to save the changes ke Cancel Figure 23 Save settings for current user question Clicking Yes will save the changes Clicking No will exit User Settings Dialog Box Clicking Cancel will return the last displayed dialog box 3 3 1 Setup gt User Settings gt Montage Defines which channels will be presented on the zzzPAT screen and in what order This setting is saved in the User Profile file The Montage page consists of a list of all signal channels available for viewing e PAT PAT signal Heart Rate Derived from the PAT signal PAT Amplitude PAT signal enveloppe SaO Arterial blood Oxygen saturation level Actigraph Actigraphy signal WP100 or WP200 Stages REM Light Sleep Deep Sleep and Wake stages Body position Snore ZZZPAT 4 2 pp Operation Manual Itamar Medical Ltd User Settings Montage Colors Options All Channels Channels In Montage WP100 Stages
103. sease Coronary artery disease Diabetes Mellitus Epilepsy Esophageal reflux Females onli menstiiakhan OK List of available medical conditions Patient s medical conditions OK Please double click on the list to add an item to the Medical History bow Medications List of available medications Patient s medications Alpha reductase inhibitors for Tx OF B P H Amphetamines Ant hypersensitive alpha blackers Anti migrainotic Ergot alkaloids 4nt Parkinsonian agents Anti papychotic or anti depressive drugs Beta blockers Calcium channel blockers Dopaminergic drugs Long acting nitrates AAS sbrodapk or inkikiters e Please double click on the list to add an item to the Medications box Figure 43 Patient Clinical Data Dialog box e Double click on the relevant items listed on the left to add them to the Patient information or add information in free text e After adding the selected data click OK to save To remove an item from your selection e Highlight the item you want to delete e Hit delete key or right click and choose Delete from the pop up menu e Click OK to continue 4 1 3 4 Retrieving patient information from previous studies This feature allows retrieving patient information from previous studies into current New Study dialog box In addition it enables viewing the list of all patients in the zzzPAT database ZZZPAT 4 2 45 Operation Manual Itamar Medical Ltd Note If a pa
104. t ZZZPAI 4 2 110 Oxymeter de saturation re saturation Substantial oxygen de saturation Operation Manual Itamar Medical Ltd Appendix C Keyboard Shortcuts General In all dialogs or menus Press Alt X X is the character in the word that has underscore Special Keys F1 Help Ctrl N New study Ctrl O Open study Ctrl F4 Close study Ctrl L Load from flash and analyze Ctrl P Print Ctrl C Copy Ctrl F Active channel fit to window Shft F Fit to window all signals Zoom in O Zoom out Ctrlt tLeft arrow Previous Event Ctrl Right arrow Next Event Shift tLeft arrow Previous Same Type Event Shift Right arrow Next Same Type Event CtrltHome First Event for channel CtrltEnd Last Event for channel CtriltR Sleep Report Ctri Sleep Indices Alt Add Increment active signal amplitude Alt Minus Decrement active signal amplitude Alt Right arrow Zoom In to next timebase Alt Left arrow Zoom out to next timebase Home Go to First Page End Go to Last Page Page Down Go to Next Page Page Up Go to Previous Page Left arrow Scroll left Right arrow Scroll right ZZZPAT 4 2 111 Operation Manual Itamar Medical Ltd Appendix D Manual Sleep data signal transfer Sending data for evaluation to Itamar Itamar Medical Fill in the required information and select Send current open st
105. te a user e Click on the User s name in the User Administration dialog box e Click Deactivate User Note Permanently removing a user from the system is not possible User s information is part of the study records and cannot be deleted Note The original user originally named Super User cannot be deactivated It can only be modified with a new name and password to ensure continued access with System Administrator s privileges ZZZPAT 4 2 20 Operation Manual Itamar Medical Ltd 3 Setting Up zzzPAT Configuration 3 1 Setup gt Set USB Drive Sets the path to the Compact Flash drive for WP100 or WP200 device Select USB Drive Select USB Drive Cancel Sg Sien All Drives All Dri Show All Drives Figure 21 Select USB Drive dialog box 3 2 Setup gt Directories Displays the zzzPAT working directory the name of the currently connected database the files directory signal files data and the USB drive Directories Setup Working Directoy C Program Files ltamar medicalz22P4 TSD ata Database QASERVER ZZZSOL Files Directory Agaserver ga_server_dbga_server_db_2 USB Drive Fs Figure 22 Set Directories dialog box 3 3 Setup gt User Settings The user can change the following Setup parameters by opening the User Settings dialog box from Setup gt User Settings User Settings setup parameters are stored in the zzzPAT database for each user either the local databa
106. the network If you wish to install this mode it is strongly advised to coordinate the installation with an Itamar Medical representative Extra training is crucial for proper operation o The Server mode is selected only once prior to installing the Clients This installation should be done on the dedicated computer which will serve as the server for the zzzPAT clients o The Client mode is selected only after installing the Server and is repeated for all clients 2 5 1 1 Standard Standalone installation only The zzzPAT Installer will assist in selecting a destination location for the zzzPAT database If the necessary folder does not exist ZZZPAT Installer will create the folder i zzzPAt InstallShield Wizard Database Destination Click Next to install to this Folder or click Change to install to a different Folder Install 222P 4T database to medicall zzzpati database This folder will hold fhe data files TSWE per study Please ensure that there is enough disk space for pour future shudies Cancel Figure 6 Database Destination dialog box If you wish to change the default folder select the Change button The Choose Folder dialog appears ZZZPAT 4 2 8 Operation Manual Itamar Medical Ltd Choose Folder Please choose the database Folder DO NOT USE MAPPED DRIVES Directories H 344 Floppy Ai H 344 Floppy Bi See Local Disk fC H Documents and Settings E LC malgi
107. tient has more than one study only the latest patient details inserted will be displayed To view a list of all the patients in the zzzPAT database e Inthe New Study dialog box Figure 38 leave the fields patient ID first name and last name empty e Click g the Search Results dialog box will open with a list of all the patients in the zzzPAT database e Select the study you need and click OK The patient s information will be retrieved into the New Study dialog box To view patients by selected categories e Enter patient ID first or last name into the New Study dialog box e Click bs the Search Results dialog box will open with a list of patients that will match the criteria inserted above e Select the patient you need and click OK The patients information will be retrieved into the New Study dialog box 4 1 3 5 Classifying the patients by special categories or groups To assign a study to a group or category e Click the More button in the Study optional section of the New Study dialog box The following dialog box will open More Study Details Comments Cancel Clear All Custom Fields CHF Hypertension MSLT Figure 44 More Study Details Dialog box ZZZPAT 4 2 46 Operation Manual Itamar Medical Ltd e You can enter free text in the Comments field and select an existing study group from the list you previously prepared in the
108. tient information Note To use the zzzPAT ability to send files to Itamar the zzzPAT station must have access to the Internet If you not have access to internet use the alternative manual way to send signal data as describe in Appendix D Manual Sleep data signal transfer A study can be saved or transferred only if it is displayed in the Signals Display Window or is stored in a Compact Flash card e Select a study ZZZPAT 4 2 79 Operation Manual Itamar Medical Ltd o by displaying it in the Signals Display Window or o by inserting the Compact Flash card with the study into the Flash drive e From zzzPAT click Help gt Prepare and Send Study to Itamar Medical Help Topics About 222P 47 view 222P 47 Error Log View Mew Patient Error Log Pack and Send Study to Itamar Medical Figure 77 Launching Transfer Files The following Dialog Box appears Pack and Send Study Submitter details mandatory Submitter Name Site Name E mail Phone Problem Description Data Source f Send Current Opened Study WIP S N 305 5 Send Study from USB Drive e C Gend WOU Device Logs Figure 78 Prepare and Send Study Dialog Box e Select Clear to clear all fields The last entered information is shown by default e Fill in the mandatory fields and check the radio button to indicate the desired option o Check Send Current Opened Study if the case study is currently displayed on the Signal Wi
109. turation level decreases desaturation during a respiratory event Actigraphy movement is often associated with respiratory episodes These four physiological parameters are incorporated into two different decision making processes that define for each epoch identified as a sleep epoch and breathing disorders These processes are described in the attached flow diagram ODI This index expresses the number of Oxygen desaturation events during an hour of sleep Desaturation event is determined when there is a reduction of 4 of the oxygen saturation baseline The index includes the events that occurred during sleep time and it does not includes events occurred during wake periods ZZZPAT 4 2 107 Operation Manual Itamar Medical Ltd REM REM events are determined for sleep epochs only based on information extracted from local windows applied to the amplitude and pulse rate time series of the PAT signal For each epoch four parameters are extracted e Mean PAT amplitude time series e Scaling exponent of the amplitude time series using Detrended Fluctuation Analysis DFA e Ratio of peak low frequency band to high frequency band in the PAT amplitude time series spectrum e Ratio of peak low frequency band to high frequency band in the PAT pulse rate time series spectrum These algorithms were optimized in clinical studies using simultaneous study of Watch PAT with automated zzzPAT analysis and in lab standard polysomnography PSG
110. ual Itamar Medical Ltd List of Tables Wale T Ser E Lu EE 19 Table2 Troubleshooting Tostallartutosgiesgs ies eege ceeds dee See exe aaa aiaiai 97 Table 3 Troubleshooting ZZZPA Mi WE 98 Table 4 Troubleshooting Shared Access Mode ZZZPAT 1sccecceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeseeeeeeeseneneaes 99 Table 5 Troubleshooting Utilities eege ee ER deste dieheievsco eee eee 100 ZZZPAT 4 2 1X Operation Manual Itamar Medical Ltd 1 Introduction to the zzzPAT 1 1 Intended Use of the Watch PAT100 amp Watch PAT200 The Watch PAT100 WP100 and Watch PAT200 WP200 are non invasive home care devices for use with patients suspected to have sleep related breathing disorders The WP100 and WP200 devices are used as a diagnostic aid for the detection of sleep related breathing disorders and sleep staging Rapid Eye Movement REM Sleep Light Sleep and Deep Sleep The devices generate a peripheral arterial tonometry PAT Respiratory Disturbance Index PRDI Apnea Hypopnea index PAHI and PAT sleep staging identification PSTAGES The devices PSTAGES provides supplemental information to its PRDI PAHI The devices PSTAGES is 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 is warranted The WP100 and WP200 are not indicated for children less than 17 years old 1 2 The zzzPAT S W
111. udy e Select Save and save the study in your local drive Preferable into disk on key or other removable drive e Browse into URL http support itamar medical com upload e Fill in the required information PI Physician Name Submitter Name Site Name Site Type Country City Phone Number e E mail e Enter study code call Itamar for code e Enter password call Itamar for password Press Submit Browse and enter the file you have saved e Enter description for file Press Send At the end of the upload process make sure to get a message List of successfully Jo L oan upload files and the list of files you uploaded List of seccessfolly uploaded fles File Name size desorption ZZZPAT 4 2 112 Operation Manual Cd Tiger 4 8 ee Pe ee ee eine Fr 8 gr em fe b s en 8 Itamar Medical Ltd Appendix E Index A Analyze gt Reload study and analyze 59 Archive 84 85 86 88 89 B Backup 89 94 C Compact Flash Defining drive 16 Installation 4 Set Flash Drive 21 D Database Tools 85 92 93 94 100 Database upgrade 16 Database Wizard 15 16 37 92 93 94 95 97 100 E Edit gt Copy 60 Event Management 60 Events Deleting 61 Events gt Add Event 60 Events gt GoTo Event 62 Events gt Select Event 62 63 Export 19 30 79 84 85 86 87 88 89 94 Export a report 63 Export From Database 94 F
112. ult list Note Clicking the Default Settings will revert to default settings losing all user defined setting 3 4 3 Setup gt General Settings gt Medications A default list of Medications is listed in the medication tab ZZZPAT 4 2 28 Operation Manual Itamar Medical Ltd General Settings Report 4ppearance Report Translation Clinical Diagnosis Clinical Recommendations Events Medical History Medications Custom Fields General Options Alpha blockers Moclify Amphetamines Se Beta blockers Calcium channel blockers Remove Dopaminergic drugs inhaled Beta agonist Hao emnin Nasal decongestants Hitra NSAIDS Default Settings Ophthalmic vasoconstrictors Sleeping pills bal l T karada z m Add to Medications Cancel Help Figure 30 General Settings Dialog Box Medications Tab To add a Medication to the list e Insert Medication name in the Add to Medication text box The Add button becomes enabled e Click Add To modify a Medication e Click on the listed Medication e Click Modify The Modify dialog box opens with the selected Medication name e Type in the change requested To remove a Medication from the list e Click on the listed Medication e Click Remove Default Settings reverts to the default list Note Clicking the Default Settings will revert to default settings losing all user defined setting ZZZPAT 4 2 29 Operation Manual Itamar Med
113. vents PAT Figure 49 Selecting the All night Window e Check the box to the left of Visible in the All Night section e Select the channel you wish to display in the All Night Window To remove the All Night Window e Use the two options mentioned above or right click on the All Night Window title window left side of the screen select Remove from View All Night Window features e The Display Area Marker that appears as a highlighted rectangle in the All Night Window See Figure 48 is the section being viewed in the Signals Display Window ZZZPAT 4 2 52 Operation Manual Itamar Medical Ltd e tis possible to navigate through the recorded data through the All Night Window by clicking on a spot on the All Night window or by dragging the highlighted rectangle e When in the All Night Window display clicking the mouse right button opens the following pop up menu Fit to Window Invert Data Show Channel Events Show Respiratory Events Grid On Off Properties Fit to Window Invert Data Show Channel Events w Show Respiratory Events Grid OonfOft Properties Figure 50 All Night pop up Menu Auto fits the All Night window s signal so it is displayed in about 80 of the window s height Inverts the y Scale and signal of the All Night window Displays channel events in the All Night window Displays respiratory events in the All
114. want Co continue i General computer information will be saved with the data Figure 80 Sending Study Confirmation e Click YES to continue Note General information about the computer configuration will be included in the transferred file This information does not contain any patient information The progress of the file transfer will be reported on the following screen 8 of zzzPATPack_16_03_2004_17_20_10 zz X Gq Uploading the file zz2PA Pack 16 03 2004 17 20 1022p to ltamar Medical UI Estimated time left 13 min 48 sec 70 0 KEB of 6 74 MB copied Transfer rate r20 kB Sec Figure 81 Data Transfer Progress Upon completion of the file transfer the following screen will appear ZZZPAT 4 2 82 Operation Manual Itamar Medical Ltd W 77PAT Information x 1 Packing and Sending data completed successfully Figure 82 Data Transfer Successfully Completed e Click OK to continue 5 5 2 Sending a file to Itamar manually If the zzzPAT station does not have Internet access or the automatic send failed to complete the file can be sent manually using the following procedure e Save the file as described in Section 5 5 e Copy the saved file to a PC that has Internet access e Launch Internet Explorer or a similar Internet browsing application e Upload the file using the Itamar ftp server see Appendix D Manual Sleep data signal transfer ZZZPAT 4 2 83 Operation Manual Itamar Medical Ltd
115. y Information Referring Physician Medical history Diagnosis and Recommendations The second page of the report presents the study results for the Selected Time Range including Sleep Summary PAT Respiratory Disturbance Index pRDI PAT Apnea Hypopnea Index pAHI Oxygen Saturation Statistics including the Oxygen Desaturation Index ODI mean maximum and minimum oxygen saturation levels Oxygen Saturation analysis Pulse Rate statistics and REM Sleep analysis It also includes graphical displays of Respiratory Events Oxygen Saturation Pulse Rate Wake Light Sleep Deep Sleep and REM stages The third page of the report presents pie charts of sleep wake states and sleep stages as well as a Respiratory indices chart Note In the Selected Time Range report the Start and End Study Times are the margins of the Selected Range 4 6 4 Report gt Event Report This report provides statistics on different event types identified by the zzzPAT automatic analysis and by the User A graphical representation provides a quick way of looking at the event distribution and the summary section provides statistical information When displayed on screen the user can double click on a particular event type either on the chart or on the relevant row below the chart to get a detailed list of all the events of this type see Figure 71 Event Report ZZZPAT 4 2 71 Operation Manual Itamar Medical Ltd ZZZPAI 4 2 Event Report Gall AET E E E
116. y the administrator login name and password and to add modify additional users refer to section 2 9 Warning e Do not attempt to modify the zzzPAT software e tis recommended to close other programs when using zZZPAT to prevent possible conflicts ZZZPAT 4 2 14 Operation Manual Itamar Medical Ltd 2 6 Upgrading from previous versions 2 6 1 Upgrading a Standalone Installation Before upgrading from a previous zzzPAT version the older version must be uninstalled The zzzPAT installer will identify if the older version has not been removed and will prompt you to uninstall it Note Uninstalling zzzPAT does not remove the zzzPAT database however it is strongly recommended to backup the database before upgrading zzzPAT e Backup the entire database of the existing zzzPAT installation see Database Wizard Backup section 7 1 3 e Uninstall the previous version using Add Remove Programs applet from the control panel e Select Setup exe from the zzzPAT installation CD ROM to start the zzzPAT installation program e Follow stages 1 6 in section 2 5 2 6 2 Upgrading a Shared Database Installation Activating the Shared Database installation on an older version zzzPAT station will update the zzzPAT software only the database will not be updated through the installer and will require a separate upgrade process described later in this section Warning An upgraded zzzPAT will not always work with older vers

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