Patient Registration & Creating Registration Reports (Sections 5 & 6)

Patient Registration (Optional)

Patient Registration is not required to use the Cardea SOLO™ ADX S400 system.

Registration

Click the Patient Registration button, Figure 6.2 below, to access this functionality. The Additional Information / Patient Demographic screen will appear, Figure 6.5 below. This information should be entered at the time the Sensor/Patch is placed on the patient. Note that the Patient Diary section is omitted, as the patient is actively recording data.

Upon return of the Sensor/Patch and processing of the recorded ECG data (see Section 6.2), entering the first 3 characters of the patient’s last name will trigger a display of the matching registered patients. With each added character the list will dynamically shorten. Double clicking on the appropriate patient will populate the screen with the demographic information entered during registration.

Figure 5.1. Selecting a Registered patient during downloading.

The Sensor/Patch Serial Number can also be entered during patient Pre-Registration. The demographic information will populate the screen when the full Serial Number is entered.

Figure 5.2. Accessing a Pre-Registered patient via the Sensor Serial #.

All demographic fields can be edited or updated, and diary information added.

At the conclusion of data processing, the patient’s registration information is deleted from the Pre-registration list.

Registration Report

Clicking the Registration Report button, Figure 6.2 below, retrieves the active list of Registered Patients and creates an Excel summary.

NOTE: Excel must be installed on the PC for this functionality to be used.

Cardea SOLO™ ADX S400 Software – Creating the Report

This section will lead you through the full report creation process, from logging in as a User, connecting the Sensor/Patch to the Smart Cable and PC, entering patient demographic and diary information, and creating the draft PDF report.

NOTE: In this manual, the ECG analysis report, referred to in various industry Standards as “Physician Report”, is referred to as “PDF report” or simply “report”.

Cardea SOLO™ ADX S400 Software’s Section 7 is for Clinical Review. It helps review ECG trace data, add or remove rhythm episodes (e.g. Atrial Fibrillation, Ventricular Tachycardia), strips, correct errors and edit the diagnostic summary to finalize the report.

User Login

On start-up the Cardea SOLO™ ADX S400 Software User Login screen will be displayed.

Figure 6.1. User Login screen.

Enter your User name and Password (if the Adminstrator included a Password when your account was setup). Clicking “Login” or Enter will present the main User Menu Options screen, Figure 6.2.

Figure 6.2. User Menu Options screen.

NOTE: The Patient Registration and Registration Report options (discussed in section 5) will be excluded if the User’s profile is not set for access to these functions, see Section 4.2 above.

To begin the process of transferring the ECG data from the Sensor/Patch to the PDF report, click the highlighted “Download ECG” button.

Data Transfer, Demographics and the Draft Report

Connecting the Electronics Module

Use the Smart Cable (C400) to transfer ECG data from the Electronics Module to the PC and Cardea SOLO™ ADX S400 Software. Plug the USB connector into the PC and the LED will turn green. Insert the Electronics Module into the Smart Cable cradle and the LED will turn green.

Figure 6.3. Electronics Module connected to the Smart Cable.

During data transfer operations both LEDs will blink simultaneously.

Starting Data Transfer

Following clicking the “Download ECG” button, the System will present the “Transfer Sensor ECG Data” screen, Figure 6.4.

Figure 6.4. Transfer Sensor ECG Data screen.

If the Smart Cable isn’t plugged in, the screen prompts you to connect it. Once connected, the screen will display a notice confirming the connection and prompting you to insert an Electronics Module from the Sensor into the Smart Cable.

Once connection to the Electronics Module is verified, the System will provide an update similar to the following:

Connect the System to the Electronics Module and click the “Start” button to begin data transfer. Progress updates will show hours processed, heart beats detected, and processing stage.

Clicking Start will also present the Additional Information data entry screen, discussed in the next section.

Demographic and Diary Data Entry

Following the start of data transfer, the Additional Information data entry screen is presented.

Figure 6.5. Additional Information screen.

Enter the patient information indicated as required.

NOTE: The (Required) patient information fields must be entered before the draft report can be generated. The Done button will not activate until all required fields have been entered.

Use the Patient ID # for free-text fields. Cardea SOLO™ ADX S400 Software analyzes heart rates and arrhythmias during wake and sleep cycles. To improve heart rate findings, record the Recording Start date, time, and approximate sleep and wake times. Removing sleep/wake analysis is possible by setting Sleep and Wake times to 12:00 AM.

Figure 6.6. Sensor ID Serial Number locations.

• The Sensor/Patch ID number is optional, and can be found on the Sensor/Patch pouch label, Sensor release liner, and Electronics Module, as shown in Figure 6.6. The barcode uses the GS1 standard format.
• A Barcode reader can be used to enter the serial number and is advised to minimize errors.
• The Primary Indications for prescribing the wearing of the Sensor should be entered into the Primary indications field. This information may be important for reimbursement for your organization. This information will be included in the PDF report.
• The Prescribing clinician, Location, and Summary report title are inherited from your User profile, as set-up by the System Administrator, and can be edited here as necessary.
• Once you have entered a start date and time, the System will enable the “Patient diary” button, located in the lower left of the screen. Clicking on this button will present a screen for entering information from the patient’s diary, if one was used.
• NOTE: Symptoms and Activity fields are limited to 50 characters.

The drop-down menus are selectable, and the user may type in any other text required. The Patient Diary entries are not required.

Figure 6.7. Patient Diary Entry screen.

• Enter the data as indicated and click the “Add” button.
• To save a Diary Entry, complete all fields except “Button Press” and click “Add.” Clicking “Done” without completing all fields will not save the entry.
• The screen will refresh and you may continue entering additional Diary entries. Once you have completed data entry, click “Done”.
• Cardea SOLO™ ADX S400 Software will examine the ECG data ±5 minutes around the entered date and time for any abnormal conditions and include a 30 second rhythm strip in the report, highlighting the abnormality if found.

The updated Additional Information screen will refresh, Figure 6.8 below.

Figure 6.8. Updated Additional Information screen.

Hovering the mouse over any of the Diary entries will invite you to right-click the entry to edit or delete the data associated with that entry.

When all the relevant information has been entered and reviewed, click the “Done” button. Cardea SOLO™ ADX S400 Software has been busy working in the background processing the ECG data and will likely be ready to incorporate the patient information into the draft PDF report.

Draft PDF Report

Following entry of the patient information, the system will finalize data transfer from the Sensor and build and present a draft PDF report. A typical first page is shown below in Figure 6.9.

Figure 6.9. Example first page of a draft PDF report.

The Initial Findings (left box at the top) and the over reading physician’s diagnosis (right box at top) may be edited – see Edit Dx in Section 7.3 below. If a logo has been selected in Admin, Section 4.1, it will be displayed at the top left of the report.

The report is structured as follows:

Header. Patient demographic information, Primary Indication for ordering the test, the prescribing clinician, office location and recording period, along with the wear time (start, end, total), percent analyzable ECG are summarized at the top of the report.

Initial Findings. Below the Header on the left is the summary of key Initial Findings. The information is presented as a bulleted list or full text depending on the User preferences. Included in these findings are the number of patient triggered events and their associated findings (if any). (See Section 4.3 above).

Clinical Findings / Over reading. The space to the right of the Initial Findings is reserved for comments by the over reading physician. See Section 7.3, Edit Dx below.

Report includes an example waveform to show a key finding. The selected waveform is based on a priority list of conditions detected, such as AFib, VT, Pause, and more. Rhythm strips are added in later pages for each condition.

The relative amplitude of the ECG traces is indicated by the vertical bars on the left side of the ECG trace. The shorter bar indicates the smaller amplitude trace and the height ratio is computed from the ratio of the trace amplitudes.

Figure 6.10. Relative trace amplitudes.

Rhythm Summaries. The summaries are partitioned into findings that occur during Sinus Rhythm and during Atrial Flutter / Fibrillation.

• Sinus. The percent of the record that is in Sinus rhythm.
• PAC Burden. Calculated from the PACs occurring during Sinus rhythm, excluding beats in runs of SVT. Reported as both average beats/day and percent burden (PACs / Total # Beats).
• PVC Burden: PVCs on record, reported as av. beats/day. Burden divided into Sinus rhythm and AFib. Daily PVC counts included in graph.
• Atrial Bigeminy Burden. The percentage of the total record duration with Atrial Bigeminy.
• Ventricular Bi/Trigeminy Burden. The percentage of the total record duration with Bi/Trigeminy.

The report shows results for Awake and Sleep periods, including number of VT and SVT episodes, average heart rate and duration. It also lists pauses and their duration, categorizing them by rhythm. Additionally, the report includes the percentage duration of PVCs, PACs, Bradycardia and Tachycardia.

Atrial Flutter / Fibrillation (AFib). The summary information follows the same format as Sinus above.

The Graphical Trend Report summarizes the entire record with a graph that displays three components of a 10-minute ECG recording window: % Atrial Flutter/Fibrillation, % Normal Rhythms, and % Unanalyzable records. Time intervals with unanalyzable percentages above 20% are indicated by a blue bar. The graph includes the smoothed average heart rate (solid line) and PVC burden (dashed line) with corresponding axis.