Model S400 Ambulatory ECG System with Analysis Algorithm
Overview
- Cardiac Insight is dedicated to helping save lives through cardiovascular research and product innovation.
- With a mission to provide affordable, high quality ECG systems, Cardiac Insight developed the Cardea SOLO™ ADX System to help clinicians characterize heart rates and rhythms over a 10-day recording period using a comfortable and lightweight wearable Sensor.
- Using our proprietary RAAPTr™ Rapid Automated Arrhythmia Processing Technology, Cardea SOLO ADX provides computer-assisted interpretation of the 2-channel ECG recording and simple-to-use tools for rapid review of ECG trace data and editing of the initial findings at the point of clinical care.
The purpose of this Quick Start Guide is to provide an overview of the Cardea SOLO ADX System. It includes instructions on how to transfer and analyze data from the Sensor.
Software Installation
NOTE: Software installation on a Windows PC generally requires Administrator privileges – see your IT staff. The Operator’s Manual, available as a PDF on the software Flash Drive, provides additional information for System setup and configuration.
| Step 1 Insert the Cardea SOLO ADX Software Flash Drive into a USB port on the PC or download from the provided link. Step 2 Double click “Cardea SOLO ADX Setup”. If a previous version of Cardea SOLO Software is already installed on the PC, an automatic Uninstall prompt will appear first. Review the License Agreement.Select “I Agree” if you agree with the terms of the license to continue the installation and click Next. |
| Step 3 Choose the directory for the install location and click Install. It is best to accept the default if you are unsure. Select if this installation is for just you, or for Everyone, and click Next. |
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Step 4
Click Next to confirm installation.
Setup will install the software and confirm installation is complete.
Administrative Setup
Step 1 Click On the PC desktop SOLO ADX icon:  Enter the word “Admin” and select/confirm an Administrative Password if desired. NOTE: Write down password and keep it safe. A lost Admin password cannot be recovered if lost. Refer to Cardea SOLO Troubleshooting Guide for lost or forgotten Admin password help. Click Login. |
| Step 2 Setup System Administration items, including organization (company) name, custom logo and patient data locations. Your custom logo will appear in the upper right corner on the 1st page of the PDF Report. The custom company name will appear in the footer. Refer to Operator’s Manual, Section 4.1.Click Manage Users |
Serial Number should be set as a required field.
| Step 3. Setup individual User Profiles. Enter each User Name and information. Be sure to check the boxes to permit access to specific software features.NOTE: A Physician or Practice name must be entered to enable the “Over- reading Physician” setting.Entered settings will appear as defaults on the “Additional Information” screen when creating a Draft PDF Report. Refer to Operator’s Manual, Section 4.2.Click Report Options. |
| Step 4 Setup PDF Report Options Arrhythmia detection settings and other report content options may be customized for each User. Refer to Operator’s Manual, Section 4.2. |
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Using the System
Step 1 Connect the Smart Cable to the PC. | The LED next to the computer icon |
| Step 2 Insert Electronics Module into Smart Cable cradle. |
The LED next to the Electronics Module icon |
on the Smart Cable will illuminate green.
will illuminate green.
User Permission via Admin Set Up is required to see/access Patient Registration
| Step 3 On the PC desktop double-click the Cardea SOLO icon:  Enter your User Name (refer to Administrator Setup). Click Login. |
| Step 4. Click Download ECG. NOTE: The Patient Registration and Registration Report button options will not be shown if the User does not have “Enable Patient Pre-Registration” Administrative permissions enabled for these features. |
| Step 5 Enter “Additional Information.” Enter patient demographic information and Sensor Serial Number (SN)*Update Sleep & Wake times if ECG analysis is desired for the patient’s typical sleep time other than the shown defaults. Complete the Required Information fields and verify that the Recording Start Date and Time are accurate. *If the Patient Registration option was used to enter information at the time of Sensor application, refer to Operator’s Manual, Section 5.1. |
| Step 6 Enter “Patient Diary” information. Click Add after each entry and to continue with Diary entries.Click Done when all entries are complete. |
| Step 7 Click Done again after verifying correct data entry. |
| Step 8 No User action required. Cardea SOLO ADX Software finalizes data transfer, rhythm analysis and presents the Draft PDF report. Refer to example of Page 1 of Draft PDF Report,” on page 11 of this Guide. |
Example: Page 1 of Cardea SOLO ADX Draft PDF Report
Initial Findings (bulleted list format option shown)
Clinician over – read comments and electronic sign off via Edit DX function
Sample ECG waveform and key statistics
Total Number of Beats Found Listed
Graphical Trends
Step 9
Review and Edit the Draft Report using available menu options or click Done if finished.
NOTE: The Edit Dx button will be grayed out and nonfunctional if the User does not have Administrative permission enabled as an “Over-reading Physician.”
The term “Draft Report” is used until the reported results are reviewed and confirmed by an over-reading physician.
CUSTOMER SUPPORT
866 554 3751 (toll free) support@cardiacinsightinc.com
Cardiac Insight, Inc. 2375 130th Ave NE Suite 101
Bellevue, WA 98005 USA Website www.cardiacinsightinc.com
Cardea SOLO™ ADX is a trademark of Cardiac Insight Inc.
All product names, logos, and brands are property of their respective owners. All company, product and service names used in this document are for identification purposes only. Use of these names, logos, and brands does not imply endorsement. Information contained in this document is proprietary to Cardiac Insight, Inc.