Cardea SOLO™ ADX S400 Software – Administrative Setup (Section 4)

Initial Start-up

The first time you start Cardea SOLO™ ADX S400 Software following installation (See Section 2.4) the Administrative Log-in screen will be presented. See Figure 4.1.

Figure 4.1. Administrative Log-in screen.

The Administrative Username is “Admin”. Authentication of the Administrator is strongly recommended, via the login protocol to the PC and /or setting the Cardea SOLO™ ADX S400 Software Admin password. On subsequent start-ups of the System, the Username will be blank. For Administrative access, enter “Admin” and, if set, the associated Password.

During startup, Cardea SOLO™ ADX S400 attempts to check a Cardiac Insight website to determine if a newer software release is available. Results of this check are shown at the lower right in figure 4.1 (“You are up to date!”).

Next, select the “Login” button to begin administrative customization. The following screen will be presented.

The “Save Patient Data Directory” stores ECG data, patient info, and PDF reports. A folder is made for each patient and Sensor worn. It can be on the PC or network location. HIPAA compliance requires a secure server. ECG data is processed on the PC and moved to the network server.

NOTE: Low Network Bandwidth. For data storage on a network device, low network bandwidth may degrade the speed of file transfers and delay the completion of the ECG analysis.

Precaution

Path Length. Microsoft Windows places a 260 character limit on pathnames. The Data Directory path length should not exceed 100 characters, allowing extended lengths for patient folder names and associated files.

If the “Save PDF Directory (Optional)” is defined, the PDF report will be copied to that location. EMR systems have tools for uploading office documents, like PDF reports, with patient records. This option makes it easier to collect PDF reports for uploading into the EMR. PDF report names are in the “LastName_FirstName_Birthdate_TestDate.PDF” format. Radio button options control when the PDF is transmitted, either when confirmed or when updated.

• Date and Time formats of choice are available and may be selected. If you change the date format after initial setup past records will not be modified to the new format.
• The Line Frequency selection supports the AC line filter used during processing. For North America this should be set to 60 Hz, and to 50 Hz for Europe and other countries as appropriate.
• While entering the patient demographic information, the Administrator can require that the Sensor Serial Number must be entered before data processing can proceed.
• The minimum duration of an atrial fibrillation episode is not universally standardized. Use the checkbox if duration must exceed 30 sec.
• You may also add the institution’s logo to the reports. Click Browse and select a JPG or PNG formatted image. The image will be added to the screen in Figure 4.2, above the associated Browse button.
• Finally, add the name of the clinic or institution.

User Setup (Manage Users)

The next step to set up the System is the creation of User profiles. It may be desirable to have different characteristics for different users, perhaps reflecting the preferences of the associated doctor, or the clinic. At least one user must be created. Select the “Manage Users” button shown in Figure 4.2. The following screen will be displayed.

To add a new user, complete the fields shown and discussed below:

• New login profile name. This will be the User name entered for login, see Figure 4.1. Passwords are not required, but are supported. User authentication, during login to the PC and/or Cardea SOLO™ ADX S400, is strongly recommended. If desired, add and confirm the Password.
• Users may offer clinical assistance to prescribing physicians and include the physician’s name in the final PDF report. A checkbox allows users to access over-reading, editing, and confirming the Cardea SOLO™ ADX S400 report. The physician’s name will be used as the confirming physician. Patients can also be pre-registered in the Cardea SOLO™ ADX S400 system during sensor placement by enabling the “Enable Patient Pre-Registration” feature.
• User access to Studies. The user can be restricted to reviewing only patients associated with the Physician.
• Managing Location. The clinic may be a part of a larger organization. For example, the Organization (Company Name, Figure 4.2) might be “Overlake Health System,” and the clinic might be “Eastlake Clinic.”
• Following entry of the required fields for a User, click the “Add” button. Continue adding Users as needed. To edit a User, use the drop-down menu option (“Select Existing Profile (Edit)”) at the top of the screen. Remember to click “Update” following any edit. When the list of Users is complete, click “Done”. The System will return to the System Administration screen. If you’re done, click the “Done” button.

Report Options

Following entry of User information, as discussed in Section 4.2 above, clicking the Report Options button shown in Figure 4.3 above will display the following window:

• The first three options are User selectable parameters to define Bradycardia [allowed limit range: 30 – 75 BPM], Tachycardia [allowed limit range: 75 – 200 BPM], and Pause Duration [allowed limit range: 2 – 5 Seconds] when the User is processing the Sensor data. Default values are shown in Figure 4.4. The next options allow Users to customize data presented in the report.
• “Report – Exclude.” option: Users may wish to include or exclude some sections of the report – clicking the checkboxes will exclude the section. See below for more details on each section of the report.
• “Abnormal ST Thresholds.” Users may select minimum ST amplitudes and durations as clinically appropriate. The amplitude setting is used for identifying both ST Elevation and Depression.
• “Report – Text Summary:” option: The first page of the report presents key findings. Selecting “Full Text” presents findings as a text paragraph. Selecting “Bullets” replaces the text summary with concise bulleted statements of key findings.
• Day Summaries in the report can show the heart rate trending data as “Avg HR View” or “RR Plot.” “RR View” is recommended for identifying complex rhythms.
• “Report – HRV Selection.” The user can select either Root Mean Square of Successive Differences (RMSSD) or the Standard Deviation of Normal to Normal intervals (SDNN).

Manage Physicians

Cardea SOLO™ ADX S400 Software supports the creation of a Physician List, which is accessible while entering patient demographic information. The demographic entry screen includes the entry of the prescribing physician, which displays the list entered here. The Physician Profile list window is shown below.

Import / Export

• The Export button (see Figure 4.2) will export all the System Administration settings to a file. This file can be used to quickly set-up additional Cardea SOLO™ ADX S400 systems, without having to re-enter all of the configuration elements. The exported file is a zipped / compressed folder.
• The Import button presents a file browser window – navigate to the previously exported compressed folder and select.
• NOTE: Importing will delete ALL settings and configurations and replace them with the imported setup.
• Following the import, the system will exit the System Administration screen, returning to the Login screen.
• NOTE: The imported administrator password is REQUIRED for the subsequent login.

Manage Updates

The Manage Updates button provides administrative support for checking a Cardiac Insight website for the availability of a new update. If a new update is available, the displayed window will look something like:

Status window provides Cardiac Insight info. Click Download to save Setup.exe to Download folder. Click Install to begin installation. Admin can directly install from Download folder. Windows Admin Privileges may be needed. Contact IT manager.

Archive / Delete

The Archive / Delete button will display all the patients currently stored in the Patient Data Directory, as shown below.

Use CTRL-Click to select patients and Shift-Click to select a range of patients. Utilize filter buttons to narrow the list based on specific characteristics. After selecting patient folders, click Accept to display an options window.

• If the Patient Data Directory is on the local PC, the administrator may move the records to the Trash.
• NOTE: Trash is not emptied – wrongly deleted folders can be returned to the Directory using Windows drag and drop functionality.
• Delete functionality is not available if the storage Directory is on a remote network drive.
• The Move to Archive button will display a folder browser to select a move-to directory.