The Display Screen. Itamar Medical Watch-PAT 200, Watch-PAT 100

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Itamar Medical Ltd.

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.

Screen Header

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.

Time Base list

Display Area Marker

Channel

Title bar

All night Display

Window

Signals Display

Window

Status bar

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

Itamar Medical Ltd.

Placing the mouse cursor on an event pops up a tool-tip that contains: y

Event name y

Event source (Analysis or User) y

Start y

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. y

To display the All-Night window, navigate through View>All Night Window, check the ‘All Night’ option.

Or View>Channels,

The following dialog box will open:

Figure 49 - Selecting the All night Window y

Check the box to the left of ‘Visible’ in the All Night section. y

Select the channel you wish to display in the ‘All Night Window’.

To remove the ‘All Night Window’:

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:

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

Itamar Medical Ltd.

It is 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. y

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

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 Night window.

− Toggles the grid in the All Night window.

− Opens up the ‘Signal Properties - All Night’ dialog box (see

Figure 51).

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: zzzPAT 4.2

Itamar Medical Ltd.

Figure 52 - All Night pop-up menu

Select Channel to

Display

Fit to window

− Allows the user to choose which channel will be displayed in the ‘All Night Display Window’.

− Auto fits the channel’s signal so it occupies 80% of the window’s height.

Invert Data

Remove from View

− Inverts the y-Scale and signal of the channel.

− Removes the ‘All Night Window’ from the main screen.

Show Channel Events

− Allows option of showing or not showing all the events on

Show Respiratory

Events

Show Y-axis

Properties the All Night channel.

− Allows option of showing or not showing only respiratory events on the All Night channel.

− Shows the Y-axis for the selected channel.

− Opens up a dialog box with the General, Y-Scale and View properties of the channel.

4.3.2 Signals Display Window

The signals display window is located under the ‘All Night’ window. It displays the channels that are selected in the View>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

Itamar Medical Ltd.

Fit to window

Invert Data

Remove from View

Active Signal

Show Channel Events

Grid On/Off

Show Values

Show Y-axis

Properties

Figure 53 - Active channel pop-up menu

− Auto fits the active channel’s signal so it occupies about

80% of the window’s height.

− Inverts the y-Scale and signal of the Active channel.

− Removes the currently active channel from the screen.

− Allows deactivating the signal.

− Allows option of showing or not showing the events in the

Active channel.

− Toggles the grid in the Active channel.

− Shows the values for each data point on the Active channel

(effective only under maximum zoom).

− Shows the Y-axis values for the Active channel.

− Opens up a dialog box with the General, y-Scale and View properties of the Active channel.

The Status Bar at the bottom of the screen contains the following information: y

Database connection (Shared or Local) y

Real Time Clock y

Highlighted segment start time y

Highlighted segment end time y

Duration y

Time (REL/ABS)

Figure 54 - zzzPAT screen Status Bar zzzPAT 4.2

Itamar Medical Ltd.

4.4 Signal Display Options

4.4.1 View>Channels

Opens the following dialog box:

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 all 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.

Opens the ‘Set y-Scale’ dialog box. zzzPAT 4.2

Itamar Medical Ltd.

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:

Mark the channel on the ‘Set y-Scale’ dialog box. y

Click

Figure 57 - Set y-Scale – per channel dialog box y

Select minimum/maximum ranges for the y-Scale or control the channel’s gain with . y

Define whether to ignore ‘Fit to Window Mode’. (See section 4.4.6).

To edit the y-Scale using the zzzPAT screen:

Activate a channel by clicking anywhere on it. y

Click on the buttons at the bottom of the channels Title Bar.

To raise or lower the range scale of a channel: y

Left click on the channel title bar and drag the scale range numbers. zzzPAT 4.2

Itamar Medical Ltd.

To zoom on a specific range of the channel:

Right click and drag to the desired range.

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>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).

4.4.5 View >All Night Channel Fit to Window

Activates the Fit to Window mode on the ‘All Night Channel’.

4.4.6 View>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 recommended to disable the ‘Fit to Window’ Mode on the actigraphy channel.

For instructions see section 4.4.2.

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.

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 xscale of the zzzPAT screen and the time is measured from the beginning of the study. zzzPAT 4.2

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.

To enable this option, highlight a section of the waveform by clicking and dragging the mouse. The option View>Zoom In and the corresponding toolbar button 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>Zoom Out

View>Zoom Out and corresponding toolbar button are enabled when the current view is zoomed in.

Activating this option returns the view back to the previous zoom magnitude.

4.4.11 View>Zoom Original

View>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>All Night Window

Enable/disable the All Night Window (See section 4.3.1).

4.5 Review, Analysis and Report Study

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.

Recorded study data is automatically analyzed after being loaded from the Compact Flash card. You can also execute automatic data analysis by clicking Analyze>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

Itamar Medical Ltd.

When used on a file that was previously analyzed and saved with an older version of zzzPAT, this function creates a new analysis using the current version of the zzzPAT software.

REM analysis is part of the automatic analysis described 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”.

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: y

Event y

Event created by…(e.g. Automatic analysis or user) y

Start y

Duration

4.5.3 Edit>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>Undo

'Undo' is enabled only after changing events, enabling the user to undo the last operation.

4.5.5 Edit>Redo

'Redo' is enabled only after using the 'Undo' option, enabling the user to redo the last operation.

Respiratory and user defined events can be added to the study by the user.

To add events:

• Mark the place you want to insert the event by clicking on the location with the mouse.

• Right click on the location and select the ‘Add Event’ command. Or by using the zzzPAT tool bar: Events>Add Event.

The ‘Add Events’ Dialog box will open. zzzPAT 4.2

Itamar Medical Ltd.

Figure 58: Add Event dialog box

• ‘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.

• To add event - Double click on the event type in the list of events. Click OK to continue.

• It is also possible to add free text events into zzzPAT signal display using

The changes in the database are saved by pressing the Save study results button. the Free Text editing box. This text will appear on the signal as an event but will not appear in the report

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

Itamar Medical Ltd.

Note

Adding or deleting a respiratory event affects the results in the report.

Allows the user to navigate through the study by certain event criteria.

The following event type search options are available:

Figure 59 - Event Type Search options

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

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>General Settings>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)

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:

Figure 62 - Report Toolbar y

To print a report, click on the printer icon. y

To export a report to a different format, such as pdf, rtf, html, etc., select the export icon . y

User can see how many pages there are in a report and choose which page to view by using the icons.

Allows adding a diagnosis and recommendations to the Sleep Report screen (see Figure

63). The information filled in this screen will appear on the first page of the Sleep Report. y

Sign the report by typing in your name or choosing it from the name menu bar. y

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

Itamar Medical Ltd.

Note

Multiple analyses may be associated with a particular study. A new analysis will be created when selecting the

‘Analyze>Reload Study and Analyze’ option on a study that had been previously ‘Set as Reported’.

Figure 63 - Clinical Diagnosis dialog box zzzPAT 4.2

Itamar Medical Ltd.

Note

Once a study is ‘Set as Reported’ any subsequent change to any of the ‘Clinical Diagnosis’ dialog fields (Reports>Clinical

Diagnosis) will trigger the following warning message:

Figure 64 - New Analysis Warning message

Click Yes to save a new analysis without overwriting the existing analysis.

Click No to cancel the new analysis request.

Generates a one, two or three page report that provides a summary of the subject's sleep study according to the settings in Setup>General Settings>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

Itamar Medical Ltd.

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 position.

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>Export/Delete) zzzPAT 4.2

Itamar Medical Ltd.

zzzPAT 4.2

Figure 66 - First page of Sleep Report

Itamar Medical Ltd.

zzzPAT 4.2

Figure 67 - Second page of Sleep Report

Itamar Medical Ltd.

zzzPAT 4.2

Figure 68 - Third page of Sleep Report (USA version)

Itamar Medical Ltd.

zzzPAT 4.2

Figure 69 - Third page of Sleep Report (non-USA version)

Itamar Medical Ltd.

4.6.3 Report>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:

Figure 70 - Sleep Report for Selected Time Range Title

To generate a report for a selected time range:

• highlight the desired section of the waveform in the Signals Display Window, by clicking and dragging the mouse.

Report>Sleep Report for Selected Time Range.

The first page of the report includes Patient Information, the Sleep Study 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.

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

Itamar Medical Ltd.

zzzPAT 4.2

Figure 71 - Event Report

Itamar Medical Ltd.

Figure 72 - Detailed Event Report

Note

Click on the upper right icon to close the details screen and return to the main report.

This report provides a summary of study results, including pRDI, pAHI, ODI and Sleep

Time.

Figure 73 - Sleep Indices report

Note

Generation of the “Sleep Report” will close the “Sleep Indices” report. zzzPAT 4.2

Itamar Medical Ltd.

4.6.6 Report>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

Itamar Medical Ltd.

zzzPAT 4.2

Figure 74 - Patient Follow Up Report (USA version)

Itamar Medical Ltd.

4.6.7 Report > 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: y

Total sleep time y

Apnea/Hypopnoea index (AHI) y

Respiratory disturbance index (RDI) y

Desaturation index (ODI) y

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

Itamar Medical Ltd.

zzzPAT 4.2

Figure 75 - Letter to the Patient

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>Print

The study signals recorded by the WP100 and the zzzPAT analysis can be printed by:

Either clicking on the print icon on the toolbar or selecting File>Print.

User has a number of options for printing (Figure 76): y

Printing the entire study y

Printing screen y

Printing specific sections defined by time range y

Printing channels zzzPAT 4.2

Figure 76 - Print dialog box

Itamar Medical Ltd.

5 Exporting Data

5.1 File>Export Data

Enables the user to export and save recorded signals data either in binary or EDF format.

**5.2 File>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>Export/Delete

See section 6.1.

5.4 Tools>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 patient 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. y

Select a study: zzzPAT 4.2

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 y

From zzzPAT click Help>Prepare and Send Study to Itamar Medical...

Figure 77 - Launching Transfer Files

The following Dialog Box appears: zzzPAT 4.2

Figure 78 - Prepare and Send Study Dialog Box y

Select default. y

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 (WP100) or in the WP200. o Check Send WP200 Device Logs in case the internal logs from the

Itamar Medical Ltd.

WP200 device needs to be sent to Itamar for troubleshooting. y

To save the study click Save…. The following dialog box appears:

Figure 79 - Saving Case Study y

Select the destination for the saved file. The file will have the following name: o zzzPATPack_DT.zzp

Where o D is the current date o T is the current time

5.5.1 Sending a file to Itamar automatically

To transfer the study to Itamar Medical’s support department: y

From zzzPAT click Help>Prepare and Send Study to Itamar Medical... y

Fill in the mandatory fields and check the radio button to indicate the desired option: o Check displayed on the Signal Window. o Check

Flash card. y

Click zzzPAT 4.2

Itamar Medical Ltd.

Figure 80 - Sending Study Confirmation y

Click

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:

Figure 81 - Data Transfer Progress

Upon completion of the file transfer the following screen will appear: zzzPAT 4.2

Itamar Medical Ltd.

Figure 82 - Data Transfer Successfully Completed y

Click

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: y

Save the file as described in Section 5.5 y

Copy the saved file to a PC that has Internet access y

Launch Internet Explorer (or a similar Internet browsing application) y

Upload the file using the Itamar ftp server, see Appendix D: Manual Sleep data signal transfer zzzPAT 4.2

Itamar Medical Ltd.

6 Tools

6.1 Tools>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:

Figure 83 - Export Dialog box

This dialog box allows to export, archive or delete study data: y

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. y

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. y

Delete function: Deletes the selected files from the database. zzzPAT 4.2

Itamar Medical Ltd.

Export to CSV function: Creates 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. y

The y

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 …\Itamar Medical\zzzPAT\Data\zzDELETE to save the deleted files). y

Delete studies permanently. The deleted files are deleted permanently.

Figure 84 - Delete studies options Dialog box y

Temporarily saved deleted files can be restored by using the Import function of the Database Tools (see section 7.1.2). y

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: y

Delete one more study and select “Delete studies. Save temporary copy in:”.

By doing so the previously saved deleted studies will be replaced by the single study deleted now, thus reducing the size of the saved files to one study only. y

Using Windows Explorer navigate to the folder that contains the saved deleted files (\Program Files\Itamar Medical\zzzPAT\Data\zzDELETE) and delete its content in its entirety.

To commence Archive Export or Export to CSV operations proceed with the following: y

Name the archive (optional) in the ‘Name’ editing box (Name can consist of up to 8 characters). y

Add comments, if desired, in the ‘comments’ editing box. y

The exported/archived files will be saved in a folder named in accordance with the following convention: zzzPAT 4.2

Itamar Medical Ltd.

Exported files: ‘zzExport_name_dd_mm_yy_hh_mm’ with “name” being the optional data entered by the user y

Archived files: ‘zzARCHIVE_name_dd_mm_yy_hh_mm’ with “name” being the optional data entered by the user y

Export to CSV files: ‘zzzCSVExport_name_dd_mm_yy_hh_mm’ with “name” being the optional data entered by the user y

You can apply a filter to the files listed in the main field, by clicking Study

Selection…. The following dialog box will open:

Figure 85 - Study Selection Dialog box y

To select 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: Unreviewed, 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 section 3.4.4 for details. y

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. y

Once ready, click: y

Start Export to export the selected studies, or, y

Start Archive to archive the selected studies, or, zzzPAT 4.2

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Start Delete… to delete the selected studies, or, y

Export to CSV to export the selected studies to CSV format. y

Click y

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>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 imports 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).

Figure 86 - Import Dialog Box

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. zzzPAT 4.2

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Locating an Archive by browsing:

Select the ‘Folder’ radio button in the ‘Import’ dialog box. The Browse button will become enabled. y

Click on the Browse button and select the file you wish to import.

Locating an Archive from 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:

Select the ‘‘Old Archives Logged in Database’ radio button. y

Click on the Archive Selection button. The following dialog box will open:

Figure 87 - Select Archive Dialog box y

Check the criteria by which you want to select the Archive. y

Insert the appropriate parameters for selection. y

Click y

You can restore the default display of all archives by clicking the All Archives button. y

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

Itamar Medical Ltd.

You can select individual studies you wish to retrieve by clicking 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. y

Click

Note

You cannot import a study that is already available in the database

6.3 Tools>Backup

Enables the user to copy the entire database to another location for back up. Upon selection the ‘Backup’ dialog box will open. y

Select the path for a backup directory by clicking on the Browse button, or by accepting the system default setting. y

Click

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>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. zzzPAT 4.2

Figure 88 - Restore Dialog box

Itamar Medical Ltd.

Warning

Restoring a backed-up database overwrites the current database replacing all the data it contained!!!

6.5 Tools>Export General Settings

Figure 89 - Export General Settings Dialog Box y

Type the directory path or click ‘Browse’ button to select the directory, where the General Setting configuration file will be saved. y

Click Export’. zzzPAT 4.2

Itamar Medical Ltd.

6.6 Tools>Import General Settings

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>User Administration

Please refer to Section 2.9. zzzPAT 4.2

Itamar Medical Ltd.

7 Database Wizard

The zzzPAT Database Wizard contains three utilities:

Database Tools - Allows an authorized administrator 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. y

Select Start>Programs>zzzPAT>Database Wizard.

Figure 91 - Database Wizard Login y

Enter Login and Password, and select the desired database Connection. y

The Database Wizard will open: zzzPAT 4.2

Itamar Medical Ltd.

Figure 92 - Database Wizard

7.1 Database Tools

Click on the ‘Database Tools’ icon . The following dialog box will appear: zzzPAT 4.2

Itamar Medical Ltd.

Figure 93 - Database Tools Wizard dialog box

7.1.1 Export From Database:

Click the ‘Export From Database’ Icon window.

in the ‘Database Tool Wizard’ y

Refer to Section 6.1 for a detailed explanation of the exporting procedure.

7.1.2 Import to Database

Click on the ‘Import to Database’ icon window.

in the ‘Database Tools Wizard’ y

Refer to Section 6.2 for a detailed explanation of the importing procedure.

7.1.3 Backup

Click on the ‘Backup’ icon in the ‘Database Wizard Tools’ window. y

Refer to Section 6.3 for a detailed explanation of the backup procedure. zzzPAT 4.2

Itamar Medical Ltd.

7.1.4 Restore

Click on the ‘Restore’ icon in the ‘Database Wizard Tools’ window. y

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 . The following screen appears: zzzPAT 4.2

Figure 94 - Configuration Tool Wizard y

Click the ‘Export General Settings’ icon to save the current General

Settings configuration.

Itamar Medical Ltd.

Click the ‘Import General Settings’ icon to apply a saved General Settings configuration.

7.3.1 Export General Settings

Click the ‘Export General Settings’ icon . y

Refer to Section 6.5 for a detailed explanation of the general settings exporting procedure.

7.3.2 Import General Settings

Click the ‘Import General Settings’ icon . y

Refer to Section 6.6 for a detailed explanation of the general settings importing procedure. zzzPAT 4.2

Itamar Medical Ltd.

8 Troubleshooting

Installation

zzzPAT installer fails to run. zzzPAT fails to recognize flash drive.

Under Windows XP, user cannot load study or operate

‘Database Wizard’ utilities, despite having proper zzzPAT user permissions.

Auto run function in

Windows is not activated.

Windows version not compatible with zzzPAT.

Hardware configuration below minimum required.

Solution

Open My Computer>zzzPAT CD and double click ‘Setup.exe’.

Must have Windows 2000 or Windows XP for zzzPAT installer to run.

Compact Flash drive not installed

Compact Flash drive needs to be re-defined.

User does not have writing permission to the drives these applications are located on.

Must have at least 128 MB RAM, and a

Pentium processor for zzzPAT installer to run.

Install Compact Flash drive, when done, insert a CF card, run zzzPAT and select

Setup>Set USB Drive (see section

Setup>Set USB Drive)

Insert a CF card, run zzzPAT and select

Setup>Set USB Drive (see section

Setup>Set USB Drive)

Check user’s writing permissions per section, and redefine as necessary.

Table 2 - Troubleshooting, Installation

zzzPAT

Analyze>Reload

Study and Analyze

User does not have permission to operate option in the zzzPAT this utility. window is disabled

Insufficient free space on hard disk

Cannot Load Study

(function is disabled) zzzPAT will not start, or behaves unpredictably

There is less than

200MB of free hard disk space

Some zzzPAT files may be damaged/overwritten

Solution

zzzPAT Administrator can modify user’s

Extended Permissions. (See section 2.9)

Free enough disk space to exceed the minimum requirement of 100MB and try again

Free enough disk space to exceed the minimum requirement of 200MB and try again

Uninstall and reinstall zzzPAT. zzzPAT 4.2

Itamar Medical Ltd.

The open file does not show REM

Events Report does not show defined header, footer and logo

Cannot generate

Sleep Report -

Sleep Report button is grayed out

File was saved with an older version of zzzPAT that did not have REM capabilities

The Report Appearance setting tab applies only to the Sleep Report

Less than 100MB of free disk space

No study is loaded or study is non valid

User cannot log on to zzzPAT

On Windows XP and

Vista zzzPAT will not open if another session is open under a different user

User is not defined in zzzPAT

Send report by email fails

Changes to Events

Names do not show up on screen zzzPAT does not support

Netscape as the email application

Events names are saved with the saved analysis.

Changes will become visible only after running analysis again

Errors while printing Non-compatible printer driver

Run the analysis by selecting

Analyze>Reload Study and Analyze

Free enough disk space to exceed the minimum requirement of 100MB and try again

Open the desired study. If the study is open, it may have invalid data and therefore is not usable

Ensure no other user left an open zzzPAT session on the PC. If you cannot verify, restart PC

Define user by zzzPAT administrator

Define Microsoft Outlook (or Outlook

Express) as the default mail client

Run the analysis by selecting

Analyze>Reload Study and Analyze

A postscript printer driver provides the most reliable operation with the zzzPAT.

Install a suitable postscript driver for the printer in use and try again

Press Alt-Tab to bring the dialog box back to the front

After clicking New

Study in zzzPAT the dialog box disappears and zzzPAT is frozen

"Enable multi-night option" does not show in New Study dialog

"Enable tamperproof testing option" does not show in

New Study dialog

Inadvertent double clicking the New Patient button may cause the dialog box to be hidden in the background

The WP200 has S/W version lower than

2.2182

The WP200 has S/W version lower than

2.2182

Upgrade the WP200 S/W to the newest

S/W (call Itamar Help Desk for the upgrade)

Upgrade the WP200 S/W to the newest

S/W (call Itamar Help Desk for the upgrade)

Table 3 - Troubleshooting, zzzPAT zzzPAT 4.2

Itamar Medical Ltd.

file

Shared Access Mode zzzPAT

User cannot log on to zzzPAT

Cannot find saved

Shared database is not available

Cannot open selected study

In Shared Access mode user may be defined in the shared database and not in the local one, or vice-versa

File saved to the other database (either the local or shared database)

Network is disconnected

Study is in use by another zzzPAT user

Solution

Define user in the second database, or,

Exit zzzPAT and log on to the other zzzPAT database (either local or shared)

•

Verify to which database zzzPAT is connected (the database connection appears in the zzzPAT status bar)

Exit zzzPAT

Start zzzPAT and select the other database to connect to

Select File>Open and search for the desired file

Make sure the zzzPAT station is properly connected to the network, and that network services are available to it. Consult your system administrator if necessary

Wait until the other user closes the study and try again

Table 4 - Troubleshooting, Shared Access Mode zzzPAT zzzPAT 4.2

Itamar Medical Ltd.

Utilities

Preparing Compact

Flash card for new study failed

WP100 only: New

Study or zzzPAT do not recognize the

Compact Flash card

WP200 only: New

Study or zzzPAT do not recognize the

WP200

Compact Flash card was removed from the

Compact Flash reader before ‘New Study’ details were saved to it

Critical files were erased from the Compact Flash card

Compact Flash card was formatted to an unsupported format

Critical files were erased from the internal sd card or the volume name has been erased

User does not have permission to operate this utility

Solution

Do not remove Compact Flash card from the Compact Flash reader before Figure 41 dialog box appears

Using Windows Explorer, copy files patient.dat and sleep.dat from Program

Files\Itamar Medical\zzzPAT\Misc to the

Compact Flash card, and try again

Reformatted Compact Flash cards cannot be used with the Watch-PAT system and have to be replaced

Format drive with volume name "WP200" and then copy files patient.dat, sleep.dat and wp200-comm.dat from Program

Files\Itamar Medical\zzzPAT\Misc to the

WP200 drive zzzPAT Administrator can modify user’s

Extended Permissions (See section 2.9)

Database Tools button in the

‘Database Wizard’ window or Tools in zzzPAT is disabled

User Administration button in the

‘Database Wizard’ window or

Tools>User

Administration is disabled

Database Tools does not open

Super User forgot his password

User does not have permission to operate this utility zzzPAT or New Study is running

- zzzPAT Administrator can modify user’s

Extended Permissions (See section 2.9)

Close zzzPAT or New Study and open

Database tools

Contact Itamar Medical Representative

Table 5 - Troubleshooting, Utilities zzzPAT 4.2

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

BELOW) OR THE PRODUCT WITH WHICH YOU RECEIVED THIS LICENSE

AGREEMENT. THIS LICENSE AGREEMENT APPLIES TO (a) ALL LICENSED

SOFTWARE, (b) ALL LICENSED PRODUCTS (AS DEFINED BELOW), AND (c) ALL

THIRD PARTY PRODUCTS INTO WHICH A LICENSED PRODUCT OR LICENSED

SOFTWARE IS INCORPORATED. SHOULD YOU HAVE ANY QUESTIONS

CONCERNING THIS LICENSE AGREEMENT, PLEASE CONTACT THE VENDOR

FROM WHICH YOU PURCHASED THE LICENSED SOFTWARE, LICENSED

PRODUCT, OR PRODUCT INTO WHICH A LICENSED PRODUCT OR LICENSED

SOFTWARE IS INCORPORATED. YOU MAY ALSO CONTACT ITAMAR AT THE

ADDRESS PROVIDED AT THE END OF THIS LICENSE AGREEMENT.

This License Agreement is a legal agreement between you (as an individual, company, organization or other entity) and Itamar Medical Ltd. (“Itamar”). By installing, copying, or otherwise using the Licensed Software, and/or by using the Licensed Product or third party product into which a Licensed Product or Licensed Software is incorporated

(“Third Party Product”), you agree to be bound by the terms of this License Agreement with respect to the Licensed Software and Licensed Products. If you do not agree to the terms of this License Agreement, including, without limitation, the Restrictions on

Use as provided in Section 2 do not install, use or copy the Licensed Software or use the Licensed Product or the Third Party Product.

The Licensed Software and the Licensed Products are protected by US patent laws, trade secret laws, copyright laws, and international treaty provisions as well as other intellectual property laws and treaties. Therefore, you must treat the Licensed Software and the Licensed Products like any other copyrighted and protected material or product. All title to the Licensed Software and all intellectual property rights in and to the Licensed Software and the Licensed Products shall remain with Itamar.

1. Definitions

1.1. “Licensed Product(s)” means the Watch-PAT100, (Watch_PAT100), the

Site_PAT200, 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

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 standalone product and some Licensed Software is incorporated as a component within a Licensed Product, in each case sold or otherwise made available, by Itamar and/or third parties. If you have received this License Agreement with a Licensed Product, which incorporates the Licensed Software as a component within such Licensed Product, this License Agreement applies to the Licensed Software.

2. GRANT OF LICENSE AND RESTRICTIONS ON USE

.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:

• Distribute, reproduce, copy, assign, rent, lease, or otherwise transfer the rights granted to you under this License Agreement to any third party except explicitly as set forth in this License Agreement;

• Reverse engineer, recompile, or disassemble, as applicable, the Licensed

Software or the Licensed Product, except as expressly permitted by applicable law; or

• 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

Itamar Medical Ltd.

4. LIMITED WARRANTIES AND DISCLAIMERS

a. Against

Infringement. Itamar hereby warrants to you that it has the right to grant you the license to use the Licensed Software and/or the Licensed Product and to enter into this License Agreement and that neither the Licensed Software nor the Licensed

Product(s) infringes the intellectual property rights of any third party. b. As to Licensed Product. Itamar warrants that the Licensed Product, with which this

License Agreement was delivered, will be free from defects in design, materials and workmanship for a period of one year from the date of delivery of the Licensed Product to you. If the Licensed Product contains a defect in design, materials or workmanship and such Licensed Product is returned to Itamar within one (1) year of delivery of the

Licensed Product to you, Itamar will repair or replace the Licensed Product, or issue a credit for the purchase price of the Licensed Product, with the choice to repair, replace or credit being within the sole discretion of Itamar. The foregoing repair, replacement or credit remedy will be your sole remedy for breach of the warranty set forth in this

Section 4(b). c. As to Licensed Software. Itamar warrants that for a period of ninety (90) days from the date of delivery of the Licensed Software to you, the Licensed Software will, under normal use, be free from defects in materials and workmanship and will perform substantially as it is intended to perform. If during such ninety (90) day period, the

Licensed Software has a defect in materials or workmanship or does not perform substantially as it is intended to perform, Itamar shall (a) attempt to correct or assist you around errors with efforts which Itamar believes suitable to the problem, (b) replace the Licensed Software with a functionally equivalent software, or (c) issue a credit for the purchase price of the Licensed Software, with the choice to correct or assist, replace or credit being within the sole discretion of Itamar. The foregoing correct or assist, replacement or credit remedy will be your sole remedy for breach of the warranty set forth in this Section 4(c). d. Limitation of Warranties. The warranties contained in Sections 4(b) and 4(c) above do not cover damage to the Licensed Products or the Licensed Software caused by accident, misuse, abuse, negligence, failure to install in accordance with Itamar’s installation instructions, failure to operate 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 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

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-Itamar software.

ITAMAR HEREBY DISCLAIMS, WITH RESPECT TO THE LICENSED PRODUCTS

AND THE LICENSED SOFTWARE, ALL OTHER WARRANTIES AND CONDITIONS,

WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY

WARRANTIES OR CONDITIONS OF OR RELATED TO MERCHANTABILITY,

FITNESS FOR A PARTICULAR PURPOSE, ACCURACY OR COMPLETENESS OF

INFORMATION, LACK OF NEGLIGENCE AND CORRESPONDENCE TO

DESCRIPTION.

5. LIMITATION OF LIABILITY

(A) TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, EXCEPT

FOR DAMAGES ARISING UNDER SECTION 4(A) ABOVE, IN NO EVENT SHALL

ITAMAR BE LIABLE TO YOU FOR DAMAGES IN EXCESS OF THE PURCHASE

PRICE YOU PAID FOR THE LICENSED SOFTWARE, THE LICENSED PRODUCT

OR THE APPLICABLE THIRD PARTY PRODUCT. THE FOREGOING LIMITATION

SHALL BE APPLICABLE REGARDLESS OF WHETHER THE ACTION GIVING RISE

TO SUCH DAMAGES IS IN TORT, CONTRACT, STRICT PRODUCTS LIABILITY, OR

OTHERWISE.

(B) IN NO EVENT SHALL ITAMAR BE LIABLE FOR ANY SPECIAL, INCIDENTAL,

INDIRECT OR CONSEQUENTIAL DAMAGES WHATSOEVER ARISING OUT OF OR

IN ANY WAY RELATED TO THE USE OF OR INABILITY TO USE THE LICENSED

SOFTWARE AND/OR THE LICENSED PRODUCT AND/OR THE THIRD PARTY

PRODUCT, OR THE PROVISION OF OR FAILURE TO PROVIDE SUPPORT

SERVICES BY ITAMAR, EVEN IF ITAMAR HAS BEEN ADVISED OF THE

POSSIBILITY OF SUCH CONSEQUENTIAL DAMAGES. THE FOREGOING

DISCLAIMER OF CONSEQUENTIAL DAMAGES SHALL BE APPLICABLE

REGARDLESS OF WHETHER THE ACTION GIVING RISE TO SUCH DAMAGES IS

IN TORT, CONTRACT, STRICT PRODUCTS LIABILITY, OR OTHERWISE.

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

Itamar Medical Ltd.

6. TERMINATION

Without prejudice to any other rights or remedies, Itamar may terminate this License

Agreement immediately if you fail to comply with any of its terms and conditions. In the event of such termination, you must, within ten (10) business days of receiving notice of termination from Itamar, cease all use of the Licensed Software and destroy all copies thereof, and cease all use of the Licensed Product (including Licensed Product incorporated within Third Party Product).

7. TRANSFERABILITY

You may only transfer or assign the rights and obligations hereunder together with the

Licensed Software and/or the Licensed Product or Third Party Product as a whole, without retaining any rights or, subject to Sections 2 and 3 above, any obligations arising after the date of such transfer or assignment, or retaining any installed or uninstalled copy of the Licensed Software, the Licensed Product or the Third Party

Product. Any attempt by you to rent, lease, sublicense, assign or transfer any of the rights, duties or obligations hereunder in any other way is forbidden and shall be null and void.

8. SEVERABILITY

Should any term or provision of this License Agreement be declared void or unenforceable by any court of competent jurisdiction in any country or countries, such declaration shall have no effect on the remainder of this License Agreement in such country or countries, or on this License Agreement in other countries.

9. NO

The failure of either party to enforce any rights granted to it hereunder or to take action against the other party in the event of any breach hereunder shall not be deemed a waiver by that party as to subsequent enforcement actions in the event of future breaches.

10. GOVERNING LAW AND JURISDICTION

This License Agreement is governed by the laws of the State of New York, excluding its conflict of laws principles. The United Nations Convention on Contracts for the

International Sale of Goods shall not apply to any of the transactions contemplated by this License Agreement.

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

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

Itamar Medical Ltd.

Appendix B: TECHNICAL SUPPLEMENT

The zzzPAT uses a set of algorithms and provides automatically the following indices and events:

• Sleep-wake events using the Automatic Sleep-Wake Algorithm (ASWA).

• Respiratory events index which includes Apnea Hypopnea and RERA: pRDI (PAT

Respiratory Disorders Index).

• Apnea and Hypopnea Index: pAHI (PAT Apnea and Hypopnea Index).

• Oxygen Desaturation Index ODI.

• REM (REM) events using the Automatic REM Detection Algorithm (ARDA).

• 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

WP100:

• 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.

• Pulse rate - derived from the above PAT signal.

• 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 saturation 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

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:

• Mean PAT amplitude time-series

• Scaling-exponent of the amplitude time-series using Detrended Fluctuation Analysis

(DFA).

• Ratio of peak low-frequency-band to high-frequency-band in the PAT amplitude timeseries spectrum.

• Ratio of peak low-frequency-band to high-frequency-band in the PAT pulse-rate timeseries spectrum.

These algorithms were optimized in clinical studies using simultaneous study of

Watch-PAT with automated zzzPAT analysis, and in-lab standard polysomnography

(PSG) 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

Itamar Medical Ltd.

ZZZPAT analysis flow diagram

Automatic

Sleep Wake

Determination

Raw actigraph signal

Automatic Sleep-

Wake Algorithm

Continue to the next epoch

Wake Epoch

Automatic REM

Detection

Algorithm

Sleep Epoch?

Yes

Raw PAT signal

Extract amplitude & pulse rate from PAT pulses

Continue to the next epoch

Substantial increase in the local scaling exponent of the DFA of the PAT amplitude

Substantial increase in the local spectral ratio of (i) the

PAT amplitude

(ii) the PAT pulse-rate

Substantial decrease in the local mean PAT amplitude

PAT NonRem

Epoch

Weighted

Sum

Sum is above threshold?

Yes

PAT REM

Epoch

Continue to the next epoch zzzPAT 4.2

Itamar Medical Ltd.

Automatic Sleep-

Wake Algorithm

PAT

Pulse-rate acceleration

Sleep Epoch?

Yes

Automatic PAT

Respiratory Event

Detection

Actigraphy movements

PAT

Amplitude

Attenuation

Oxymeter de-saturation re-saturation

Combined score

CS2

Very High CS2

Moderate CS2

& minor oxygen re-saturation

Substantial oxygen desaturation

PAT Respiratory

Event

zzzPAT 4.2

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

– Zoom out

Ctrl+Left arrow – Previous Event

Ctrl+Right arrow – Next Event

Shift+Left arrow – Previous Same Type Event

Shift+Right arrow – Next Same Type Event

Ctrl+Home

Ctrl+End

Ctrl+R

Ctrl+I

– First Event for channel

– Last Event for channel

– Sleep Report

– Sleep Indices

Alt+Add

Alt+Minus

– Increment active signal amplitude

– Decrement active signal amplitude

Alt+ Right arrow – Zoom In to next timebase

Alt+ Left arrow – Zoom out to next timebase

Home

End

Page Down

Page Up

– Go to First Page

– Go to Last Page

– Go to Next Page

– Go to Previous Page

Left arrow

Right arrow

– Scroll left

– Scroll right zzzPAT 4.2

Itamar Medical Ltd.

Appendix D: Manual Sleep data signal transfer

Sending data

Open in zzzPAT the study you want to send

for evaluation

Select Æ Prepare And Send Study to

to Itamar

Itamar Medical… y

Fill in the required information and select

“Send current open study” y

Select “Save” and save the study in your local drive (Preferable into disk on key or other removable drive) y

Browse into URL: http://support.itamarmedical.com/upload y

Fill in the required information y y y y y y y y

PI / Physician Name

Submitter Name

Site Name

Site Type

Country

City

Phone Number

E-mail y

Enter study code: call Itamar for code y

Enter call Itamar for password y

Press y

Browse and enter the file you have saved y

Enter description for file y

Press Send y

At the end of the upload process make sure to get a message: “List of successfully upload files” and the list of files you uploaded zzzPAT 4.2

Itamar Medical Ltd.

Appendix E: Index

Analyze>Reload study and analyze · 59

Archive · 84, 85, 86, 88, 89

Backup · 89, 94

Compact Flash

Defining drive · 16

Installation · 4

Set Flash Drive · 21

Database Tools · 85, 92, 93, 94, 100

Database upgrade · 16

Database Wizard · 15, 16, 37, 92, 93, 94, 95,

97, 100

Edit>Copy · 60

Event

Management · 60

Events

Deleting · 61

Events>Add Event · 60

Events>GoTo Event · 62

Events>Select Event · 62, 63

Export · 19, 30, 79, 84, 85, 86, 87, 88, 89, 94

Export a report · 63

Export From Database · 94

File>Close Study · 50

File>Exit · 50

File>Export Data · 79

File>Export Events · 79

File>Load Study and Analyze · 48

File>New Study Details · 38, 39, 48

File>Open Study · 49

File>Print · 78

Hardware Requirements · 3

Help

Prepare and Send Study to Itamar Medical ·

80, 81

Import to Database · 87, 94

ODI · 65, 66, 71, 74, 107

pAHI · 65, 66, 71, 73 pRDI · 65, 71, 74, 107 pREM · 66, 107, 108

Printing · 78

Print a report · 63

Report · 63

Clinical Diagnosis · 63

Event Report · 71, 72, 73

Patient Follow-up Report · 74

Sleep Report · 65, 67

Restore · 89, 95

Setup>Directories · 21 zzzPAT 4.2

Itamar Medical Ltd.

Setup>Set Flash Drive · 21

Setup>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

Transferring a Study to Itamar Medical · 79

User

Add User · 18

Deactivate · 20

User Administration · 18, 20, 92, 100

View >All Night Channel Fit to Window · 58

View>Activate Channel Fit to Window · 58

View>All Night Window · 52, 59

View>Channels · 52, 54, 56

View>Fit To Window Mode · 58

View>Grid On/Off · 58

View>Relative Time · 58

View>Set y-Scale · 56

View>Study Details · 51

View>Time Base · 58

View>Zoom In · 59

View>Zoom Original · 59

View>Zoom Out · 59

Windows XP

Permissions · 97

Restrictions · 2

zzzPAT

Installation · 5

Upgrading · 15

Using · 37 zzzPAT 4.2

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