Getting Started – Cardea SOLO™ ADX S400 System Components (Section 2)

Cardea SOLO™ ADX S400 Software Blister Pack

The package contains:

A USB Flash drive with Cardea SOLO™ ADX S400 Software

• The Flash Drive is used to setup and install the Cardea SOLO™ ADX S400 Software.

NOTE: This Operator’s Manual, Troubleshooting Guide, and a Quick Start Guide are available as standalone PDFs on the Flash drive. This Operator’s Manual is also available from the main software menu.

Cardea SOLO™ ADX S400 Smart Cable Shipping Carton

The package contains: Smart Cable

Following wear, the Electronics Module is removed from the Sensor and connected to a Windows^® PC using the Smart Cable.

Cardea SOLO™ ADX S400 Sensor Shipping Carton contains: Sensors/wearable patches: Five (5) individually packaged Sensors and instructions for use specific to the Sensor.

User-Supplied Personal Computer (PC) Requirements

Protect your PC from malware with software and hardware devices. Regular malware scans are recommended to avoid misdiagnosis.

Secure the PC for Cardea SOLO™ ADX S400 to prevent unauthorized access that could compromise diagnostic information and analysis software.

PC Supported Operating Systems and Associated Components

Windows^® 10 and higher.  Microsoft .NET Framework 4.8 and Visual C++ 2022 Runtime library. See: https://dotnet.microsoft.com/en-us/download/dotnet-framework/net48 https://docs.microsoft.com/en-US/cpp/windows/latest-supported-vc-redist?view=msvc-170

Windows can be customized by users using Control Panel\Display to increase text size, however this may cause issues with the display of Cardea SOLO™ ADX S400 windows.

PC Hardware Requirements

• Windows^® compatible personal computer
• Disk: 10 GB of user accessible free disk space or greater
• NOTE: Cardea SOLO™ ADX S400 checks the available disk space for saving patient ECGs and associated information at start-up. If the available disk space is less than 10 gigabyte, a message will be displayed. On average, a Sensor’s ECG recording data and associated PDF report will require about 1.2 gigabyte.
• CPU: Dual Core CPU @ 2.5 GHz or greater, 64-bit (x64) processor or equivalent
• Display: 1300 x 768 or higher resolution, Memory: Minimum 4 GB of system memory, Pointing Device: Windows^® compatible pointing device, Keyboard: Windows^® compatible keyboard, Ports: 1 available High Speed USB 2.0 port (minimum)
• Use only a certified PC to avoid operator electrical shock. Ensure compliance with IEC 60601-1-2 standards for electromagnetic interference. Disabling patient monitoring equipment requires approval from the attending physician. Other equipment can interfere with the Cardea SOLO™ ADX S400 and PC’s function. Use a laptop with a UL rated power supply.

Hardware Setup

Unreliable power can interrupt Physician Report creation. PCs without a charged internal battery should use surge protectors and Uninterruptible Power Supplies (UPS). If a power outage/PC power loss occurs during ECG transfer, analysis, and patient demographic information entry, restart the report creation process (refer to Section 5).

Cardea SOLO™ ADX S400 hardware setup is depicted in Figure 2.1 below.

Use medical grade power supplies for peripheral equipment, like printers, that are directly connected to a patient’s PC and located near the patient. These power supplies should be certified to IEC/EN 60950-1 or IEC 62368-1, or have a UL or equivalent safety agency rating.

Cardea SOLO™ ADX S400 Software Installation

Insert the flash drive into your PC, and double click on the “SOLO-ADX” Windows Installer to start the Cardea SOLO™ ADX S400 software installation. The first screen will be the Installer Set-up Wizard Welcome screen (Figure 2.2).

Click Next and the Wizard will present the License Agreement Screen:

Click “I Agree” and then click Next.

The Wizard will next present the Installation Folder and User set-up options:

Clicking Next will confirm your set-up options have been completed and installation is ready to start:

Next, the Wizard will install the System and provide a progress bar as the installation proceeds:

At the completion the Wizard will notify you that the installation has been successfully done.

NOTE: If installing on an older PC, check to confirm that the .Net Framework is up-to-date. See Section 2.4.1 above.