Certification Exhibit FCC ID: JIAAWR1 IC: 6041A-AWR1 FCC Rule Part: 15.209 IC Radio Standards Specification: RSS-210 ACS Report Number 08-0085 - 15C Manufacturer: Mini Mitter Company, Inc. Model(s): ActiReader Manual (Part 2 of 3) 5015 B.U.
S ECTION 2 GETTING STARTED WARNING! Actiware / Actiware-CT is for use only in a clinical, research, or home care provider setting. The workspace of the Actiware program is similar to many software applications. Dockable windows give the user direct access to the Actiwatch or subject data stored in the selected database. They also provide control over analysis viewing and exports. The Database Viewer and the Properties Viewer are docked at the left side of the main Actiware window by default.
Main Window Actiware workspace, full-window The main Actiware window can be broken into three main sections: • • • Toolbars Database Viewer Properties viewer Toolbars The Menu Bar is similar to most software applications. Keyboard shortcuts, actuated by pressing the ALT key plus the hotkey letter, (identified by an underscore) can be used to navigate through the toolbar menus.
The Standard toolbar, just below the Menu Bar, includes shortcuts to associated functions within the Actiware software program. Hover your mouse over the icon for a short text description. Standard Toolbar Icons Create A New Subject Edit Subject, Data, or Analysis Configure My Actiwatch Show Audit Trail Retrieve Data from My Actiwatch Open the Database Viewer Import an .awd File Open the Properties Viewer The following four icons determine how the data are shown in the Analysis window.
The Actogram View toolbar is used for adjusting the viewing properties of an Actogram, and is available only when an Actogram is present. Changes made to this toolbar are immediately visible in the currently selected Actogram. Actogram View Toolbar • • 2-4 Getting Started Days Displayed: controls how many days are displayed in the visible part of the Actogram window. Use the scroll bar on the right of the Actogram to see the remaining days.
• • • • Activity Scale: adjusts the maximum value of activity counts displayed on the Actogram. Pull down or type directly into this control to set the activity scale. Illuminance Scale: adjusts the maximum illuminance value displayed on the Actogram. Pull down or type directly into this control to set the scale.
Subjects, Actiwatch data, and Analyses are shown as indicated below: Level Content 1st Level (Subject) Subject Identity (Sorted Alphabetically or Numerically) 2nd Level (Actiwatch Data) Local Start Time (Sorted by Date) 3rd Level (Analysis) Analysis Name (Sorted Alphabetically) Commonly used functions can be accessed by right-clicking on an item in the Database Viewer and using the popup menu.
Properties Viewer The Properties Viewer displays information for the database item that is currently selected in the Database Viewer; hence the Database Viewer and Properties Viewer are linked. Click the + or – next to the Subject, Actiwatch Data, or Analysis to expand or collapse the properties related to that database item. Left-click on an item to see a description of the property in the notes area at the bottom of the window.
Actogram An Actogram is a graphic view of the rest/activity history of a subject. Data are displayed in stackable 24-hour periods which allow the user to immediately determine sleep/wake patterns. The Actogram provides the ability to select periods of time, known as intervals, and to provide statistics for these times of interest. (See Setting Intervals later in this section.) There are multiple ways to open an Actogram. The most direct way is: 1.
You can also open an Actogram by clicking the View > Actogram menu, or by clicking the icon on the Standard toolbar at the top of the window. Use the Actogram View toolbar (displayed on the right side of the window) to adjust the view settings for the Actogram. Note: The sleep/wake scoring algorithm is applied automatically to the activity in the entire data set. Epochs scored as wake are indicated by a red mark below the X axis, whereas epochs scored as sleep have no mark below the X axis.
Setting Intervals Adding an Interval Selection to an Actogram An interval is a user-defined selection of time that allows you to graphically select and analyze data for statistical calculations. For calculation of statistics for specific periods of time, it is necessary to select intervals and assign an interval type to them. The Interval feature in Actiware provides a robust data selection, exclusion and quantitative tool.
Sleep Intervals Data in these intervals represent periods of time in which the subject is likely to be asleep. These intervals are created automatically by the program once a Rest Interval has been set. They represent the period of time between Sleep Onset and Sleep End but are not indicated by any shading. Active Intervals Data in these intervals represent periods of time in which subject activity indicates that they are alert and engaged in physical activity.
There are three ways to set intervals. The quick method uses the mouse and hotkey combinations: Quick Method 1. Hold down the CTRL key on the keyboard. 2. Click the left mouse button where you want the start of the interval to be. Interval Start Time 3. While still holding down the CTRL key, click the right mouse button where you want the end of the interval. Interval End Time If you set an interval flag in the wrong location and want to move it, repeat the above process.
Fine Control Method To set your intervals graphically to the nearest epoch, use the following procedure: 1. Click the left mouse button on the Actogram to place the epoch label. 2. Use the keyboard arrow keys (←, →, ↑, ↓) to move the epoch label to the desired interval start time. Close-up of Interval Markers on Actogram 3.
6. As with the Quick Method above, use one of the following hotkey combinations to set the type of interval you want: CTRL + R CTRL + C CTRL + E CTRL + W CTRL + S Insert REST interval Insert CUSTOM interval Insert EXCLUDED interval Insert Forced WAKE interval Insert Forced SLEEP interval Note: During the interval creation process you can press the keyboard Escape key to clear the markers.
5. Click the Add Interval(s) button to add the interval, or Close to cancel. You can repeat steps 2 through 5 for each interval without closing the Add Interval window. Note: You can also click the right mouse button in the Actogram, or use other sub-menus under the Interval main menu to set interval markers or insert intervals. Interval Quick Start Help The Interval Quick Start Help message provides an overview of the interval functions.
Removing Intervals To remove a single interval simply click the left mouse button in the interval you want to delete, then press the Delete key. To remove all intervals, right click on the Actogram and select Clear All Intervals (also accessible from the Interval menu) To remove all intervals of a specific interval type, use the Interval menu, or the corresponding keyboard shortcuts (such as CTRL + ALT + C to clear all custom intervals).
Viewing Statistics The Statistics Table is one of two main ways to display the calculated sleep/wake output. Interval, activity, mobility, sleep, illuminance, and score statistics are automatically calculated for intervals that are set by the user. 1. View > Statistics Table Click on the tabs at the top of the window to view calculated statistics for different types of intervals. Use the scrolling tools to move through the list of intervals or to view different columns of statistics.
2. Statistics Select the Statistics tab (mouse-click) to view the available statistic properties. Check those statistics that you want to include. Actiware includes Select All, Deselect All, and Restore Defaults buttons for ease of use. 3. Click OK to save your selections or Cancel to unaccept. Your selections will appear in the Statistics Table and be included in exported and printed data. Tools > Options > Statistics See Advanced Usage in Section 4 for statistic definitions.
Exporting Data Once you have added intervals and analyzed your data, you can export the retrieved raw data or statistical results to a text file that can be easily loaded into Microsoft Excel, FAST, or a database program of your choice. There are three types of export files that can be created using Actiware: Standard Individual Export File This is a comma delimited ASCII text file (.csv) that can be opened directly by Microsoft Excel. It contains the data and analysis results for one analysis.
Combined Export File This is a comma delimited ASCII text file (.csv) that can be opened directly by Microsoft Excel. It contains the data and analysis results for intervals from multiple analyses. These analyses can be from any number of subjects or Actiwatch data records in the currently opened database. Use the Text File Export Batch Wizard, accessible from the Tools > Text File Export Batch menu to create this file (or many Standard Individual Export Files).
Print Report You can generate a printed report of your Actogram and statistical results for the currently selected analysis. To generate the report, click File > Print Report, or click the button on the Standard toolbar. You will be presented with a Windows printer dialog where you can select the printer, number of copies, and paper orientation (such as Portrait or Landscape). Note: The contents of the printed report can be customized using the Tools > Options window.
New Subject Once a database exists it can be populated with subjects and subject collected data. To add or edit a subject, first open the database. Select File > Database > Open, as described on the previous page. To add a new subject to a database, do the following: 1. Click File > New Subject. This will open a New Subject window to allow for the capture of demographic data. 2.
Deleting/Hiding Subjects For purposes of data tracking, you cannot delete subjects from a database. You can hide them by checking the Hide Subject box. Once hidden, a subject will not appear in the Database Viewer. Hidden subjects may be revealed by right clicking in the Database Viewer and selecting View Hidden Subjects.
2-24 Getting Started
S ECTION 3 COMMUNICATIONS The Actiware software is used to configure the Actiwatch device and retrieve data from the Actiwatch through the use of the ActiReader. To set up the ActiReader, see Installation and Setup in Section 1 of this manual. Configure Actiwatch Overview This wizard will configure an Actiwatch for data collection. This wizard assumes that the ActiReader or Actiwatch Reader is connected to the computer and the appropriate COM port is selected.
Configure Actiwatch Wizard Welcome window Configure Actiwatch Configure Actiwatch 1. Communications > Configure Actiwatch This will launch the Configure Actiwatch Wizard. 2. Remove the wrist/foot bands from the Actiwatch (optional). The bands may interfere with proper Actiwatch placement. 3. Place the Actiwatch on the reader. The green dot on the metal side of the Actiwatch must align with the green dot on the ActiReader.
Edit Subject Information Select subject from the dropdown list or use the ‘New Subject’ button to add a new subject to the database. 6. Select a current subject from the dropdown list and then click Edit Subject to make updates. When an existing subject is selected from the dropdown menu, the areas below (Subject Name, Subject DOB, Age, and Gender) will pre-populate with the information stored in the database. Note: The subject must be in the current data file to be accessible from the dropdown menu.
Data Collection Setup During the Data Collection Setup, you can configure the Actiwatch setup items, including start time, epoch length, and time zone with a simple mouse click. Expanded window displaying the Actiwatch Details. Epoch length The period of time Actiwatch will accumulate activity counts before saving the sample to memory. Select the epoch length by clicking in this field. The choices will appear sequentially.
Epoch Length Number of Epochs per Day 5760 2880 1440 670 288 144 96 15 seconds 30 seconds 1 minute 2 minutes 5 minutes 10 minutes 15 minutes Maximum Delay in Start Time 5 days 11 days 22 days 49 days 114 days 228 days 342 days Note: For sleep analysis it is recommended you select an interval of one minute or less. Data with sampling epochs of greater than two minutes cannot be analyzed using Actiware-Sleep analysis.
Actiwatch-Score Alarm Click the Enable Alarm Scheduling box and format the Score Alarms with the following actions. • Add Manual Alarm • Add Recurring Alarm • Delete Alarms (select item in list) • Clear List • Print List After establishing the Actiwatch-Score Alarm schedule, you can print a listing. Actiwatch-Score Alarm window CAUTION! Do not remove the Actiwatch from the ActiReader during the Configure Actiwatch Wizard process until instructed to do so. 10. Click Next to continue.
Retrieve Data from Actiwatch Overview This wizard will assist you in retrieving the physiological data from an Actiwatch device. When the retrieval process is complete, the resulting data will be written to your selected database for analysis and export. This wizard assumes that the ActiReader or Actiwatch Reader is connected to the computer and the appropriate COM port is selected. Please refer to Installation and Setup in Section 1 of this manual.
Retrieve Data from Actiwatch Retrieve Data from Actiwatch 1. Communications > Retrieve Data from Actiwatch. Start the Retrieve Data from Actiwatch Wizard. Click Next to continue. 2. Remove the wrist/foot bands from the Actiwatch (optional). The bands may interfere with proper Actiwatch placement. 3. Place the Actiwatch on the reader. The green dot on the metal side of the Actiwatch must align with the green dot on the ActiReader.
5. When the Retrieval Successful! message appears, click the OK button. 6. Check the Launch Actogram when the wizard finishes box to view the Actogram data immediately. 7. Click the Finish button to exit the wizard. Retrieve Data Complete window Note: Actiware-CT requires the user to ‘Sign and Save’ the data by using a Windows or Network username and password. Please contact your local administrator with any issues or questions.
3-10 Communications
S ECTION 4 ADVANCED USAGE Actiware provides greater flexibility to researchers and clinicians when viewing and analyzing data. Advanced users can take advantage of the Actiware Toolbars to manipulate how the data is viewed and exported. Items covered in this section: • Program Options (Tools > Options) • Data List • Batch Export • Import AWD files • Graph Your input is vital to us. Please explore the program fully and give us your feedback.
Program Options Customize the Actiware software and data properties through the program options window. Select Tools > Options from the main menu bar to access the option tabs. Tools > Options Note: After you have finished making all of your changes in the options window, click OK to accept or Cancel to not accept. General Tab (Tools > Options > General) Select the COM port from the dropdown menu. To reset all Help Window reminders, check the Reset Reminder Notes button.
Analysis Tab (Tools > Options > Analysis) An analysis includes parameter settings and interval settings as inputs. Use the Analysis tab for setting parameter values (see Section 2 for how to set intervals). Definitions of each analysis parameter are given on the next few pages. You can also see the definitions of each parameter on screen when running the Actiware software by holding your mouse cursor over the parameter names on the left side of the Analysis tab.
Analysis Parameter Definitions Wake Threshold Selection Selected level or method of setting the Wake Threshold. If Automatic is selected, the Wake Threshold will be computed automatically based on activity data. Wake Threshold Value The number of activity counts used to define wake. Detail: Level of activity that is compared to a value (x) generated by the Actiware sleep algorithm for each epoch. If (x) is above the Wake Threshold, then the epoch is scored as wake.
Actogram Tab (Tools > Options > Actogram) These are the default Actogram viewing properties. Each time an Actogram is opened, it will be displayed with these properties. Adjusting these properties will not affect any open Actograms. To view the changes, close and reopen the Actogram. Click the Restore Defaults button to reset to the factory released settings.
Statistics Tab (Tools > Options > Statistics) Select the items of data displayed from the analysis. Changes made here will impact exported and printed data, and the statistics table window contents. Place your cursor over an item to get a brief definition of that item. Click Select All to include all items in your statistical analysis. Click Deselect All to remove all items from your statistical analysis. Click the Restore Defaults button to reset to the factory released settings.
Data List Tab (Tools > Options > Data List) Select the columns to be displayed in the Data List window. Changes made on this tab will impact the content of exported files and printed reports. Click Select All to include all items in the Data List. Click Deselect All to remove all items from the Data List. Click Restore Defaults to return the settings to the factory presets. Changes made in the Tools > Options > Data List window will be immediately displayed in the View > Data List window.
Export Tab (Tools > Options > Export) Select the items you want to include in your export file (also applies to the Copy > Export Text to windows clipboard function in the non-CT version of Actiware). Use the Statistics tab to select individual statistics. Use the Data List tab to select individual columns of data. Click Select All to select all of the types of data. Click Deselect All to uncheck all of the types of data. Click Restore Defaults to return the settings to the factory presets.
Print Report Tab (Tools > Options > Print Report) Select the items you want to include in your printed report. Click the Full Header box to include a first page of header information (recommended). Click the Actogram box to include the Actogram graphic in the report. You can select the number of Actogram days to print per page. Click the Statistics box (and subboxes) to include statistics for various types of intervals (by default the report will include Summary Statistics only).
Data List 1. View > Data List You have selected to view a listing of the currently active data as a function of time (epoch-by-epoch). 2. Click the Epoch-by-Epoch List tab or the Marker/Score List tab to view the data list for that type. Use the scroll bars to move up and down each List and to pan across data columns as necessary. You may want to maximize the window size by clicking the ‘Maximize’ button in the upper right corner.
Text File Batch Export This option is used when you want to export data from multiple analyses for the currently open database. You can elect to send these data to individual text files or to the same composite file. Text File Export Batch Wizard Welcome window 1. Tools > Text File Export Batch This will launch the Export Batch Wizard. Confirm that the currently active database is the one you want to export from. 2. Click Next.
3. Click Browse. Use this button to determine the destination for any export output using the Browse button and the Windows File Dialog. 4. Click the Options button to make any changes. 5. Click Next. 6. Select the data that you want to include in the export file by checking the boxes. Select data to export Note: The controls for this window are hierarchical. If you select a subject, or Actiwatch data entry all analyses associated with that subject or Actiwatch data set will be included in the export file.
7. Suppress Errors Messages box. When this box is checked, you will not be prompted if an error occurs during the batch process. If a file alrady exists, an automatic filename will be created. 8. Overwrite Existing Files box. Indicate if you want to overwrite existing export file(s) without being prompted. 9. Click Next to process your data and create the export. More options are available when using the Text File Export Batch Wizard 10. Click OK when the batch process is completed.
Import AWD Files Note: .AWS files cannot be imported. Only .AWD (Actiwatch) files can be imported. Import AWD You can import data files collected with previous versions of Actiware (ActiwareSleep/Rhythm v3.4 and earlier). 1. Left mouse click to highlight the subject you want to import the AWD file to. If you do not already have a subject created, use File > New Subject menu. 2. Click File > Import AWD. File > Import AWD 3. Use Windows File Dialog to Browse to the location of the AWD files.
4. Click Yes to edit the Actiwatch Data properties or click No to bypass. 5. The data is ready for analysis.
Graph View View The Actiware toolbars provide many new features to assist you with the data. Graph 1. View > Graph This is the Graph window for viewing Actiwatch data along a single axis. View > Graph Graph Icons 2. View > Toolbars > Graph When viewing a graph, the Graph Icons are available in the standard toolbar. These icons allow you to 1. Print the graph. 2. Edit Graph Display Properties. 3. Copy a picture of the graph to the Windows Clipboard.
Graph Help The Graph Help window provides useful information when using the Graph view. Edit Graph Display Properties 1. Tools > Edit Graph This more advanced feature allows you to edit the Graph GUI, display and printing features, and plotting parameters of the graph.
4-18 Advanced Usage