Introduction

The SOLO and ADX wearable sensor/patches are skin-applied ambulatory ECG recorders used for diagnosing cardiac health during daily activities. They can be used on patients with at least 15 cm anterior axillary line spacing, including children.

Cardea SOLO is an innovative wearable ECG recorder designed by Cardiac Insight Inc. It features a single ECG lead with two electrodes, allowing for the recording of accurate digital ECG data. The device seamlessly transmits this data via USB to a Windows-based software provided by Cardiac Insight Inc. The software offers a comprehensive suite of functions, including analysis, editing, report generation, and overreading.

Cardea SOLO focuses solely on ECG monitoring and does not include any additional sensors. There are no accelerometers or temperature sensors integrated into the device. As a result, it does not measure body or skin temperature, and it does not provide motion, position, or step count information, as it lacks an accelerometer. It does not have Bluetooth and so it cannot transmit data to an APP. It’s important to note that Cardea SOLO received FDA approval in 2017 and has since become a trusted choice in the market.

On the other hand, the Cardea ADX M400 represents the next level of ambulatory ECG monitoring technology. This wearable device features multiple ECG leads, specifically three electrodes that provide six leads for enhanced ECG monitoring capabilities. Along with digital ECG data, the ADX M400 also records motion, position, and step count, thanks to the integrated accelerometer sensor.

Similar to Cardea SOLO, the ADX M400 transmits data to the Windows-based software via USB. However, what sets it apart is the additional option of Bluetooth transmission. This means that users can conveniently transfer data wirelessly to a smart device equipped with Cardiac Insight Inc’s dedicated APP by simply pressing a button on the device.

Although the ADX M400 lacks a temperature sensor, its accelerometer offers valuable motion and position sensing capabilities, providing further insights into the user’s activity. This combination of ECG and accelerometer data allows for a more comprehensive analysis and interpretation of the user’s cardiac health and activity levels.

In summary, both Cardea SOLO and Cardea ADX M400 offer cutting-edge wearable ambulatory ECG monitoring solutions. While Cardea SOLO focuses on single ECG lead monitoring and does not include extra sensors or Bluetooth capabilities, the ADX M400 takes monitoring to the next level with multiple ECG leads, accelerometer data, and the convenience of Bluetooth data transfer to a smart device.

In summary, both Cardea SOLO and Cardea ADX M400 offer cutting-edge wearable ECG monitoring solutions. While Cardea SOLO focuses on single ECG lead monitoring and does not include extra sensors or Bluetooth capabilities, the ADX M400 takes monitoring to the next level with multiple ECG leads, accelerometer data, and the convenience of Bluetooth data transfer to a smart device.

The SOLO and ADX wearable sensor/patches record ECG data to help diagnose cardiac disease. They are not for use during defibrillation and must be removed beforehand.

Do not use if: 1. Allergic to adhesives or hydrogels, or family history of skin allergies. 2. Life-threatening arrhythmias or need inpatient monitoring or immediate ECG analysis. 3. Pacemaker or active stimulator devices, as they may interfere with ECG analysis.

Do not use the SOLO and ADX wearable sensor/patches on patients who are not competent to follow instructions for use for the prescribed monitoring period.

Do not use the SOLO and ADX wearable sensor/patches in combination with external cardiac defibrillators or high frequency surgical equipment or near strong magnetic fields or devices such as MRI.

Clinicians must rely on more than just ECG analysis to detect cardiac conditions. Some conditions may not show up on an ECG or may only be temporary. The patient’s symptoms, physical exam, and medical history are crucial in assessing their cardiac health.

Clinicians are responsible for collecting, reviewing, interpreting, and diagnosing ECG data for patients’ cardiac health. Good clinical judgment is crucial for deciding when further testing, treatment, or specialty care is needed.

Definitions of Symbols Used

Warning	Indicates a potentially hazardous situation, which, if not avoided, could result in death or serious injury.
Caution	Indicates a potentially hazardous situation, which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices. ISO 15223-1:2021 Symbol 5.4.4
	Do not re-use. Indicates a medical device that is intended for one use. ISO 15223-1:2021 Symbol 5.4.2
	Consult instructions for use. ISO 15223-1:2021 Symbol 5.4.3
	Temperature limits. Indicates the temperature limits to which the medical device can be safely exposed. ISO 15223-1:2021 Symbol 5.3.7
	Humidity limitation. Indicates the range of humidity to which the medical device can be safely exposed. ISO 15223-1:2021 Symbol 5.3.8
	Atmospheric pressure limitation. Indicates the range of atmospheric pressure to which the medical device can be safely exposed. ISO 15223-1:2021 Symbol 5.3.9
	Use by date. This symbol is accompanied by a date YYYY-MM-DD to indicate the device should not be used after the date shown. ISO 15223-1:2021 Symbol 5.1.4
	Batch or lot code. This symbol is accompanied by identifier of manufacturing lot. ISO 15223-1:2021 Symbol 5.1.5
	Catalog number. This symbol is accompanied by the manufacturers serial number. ISO 15223-1:2021 Symbol 5.1.6
	Type BF Applied Part.
	Protected against the effects of temporary immersion in water.
	This product contains no natural rubber latex.
	Serial Number. This symbol is accompanied by the manufacturers serial number. ISO 15223-1:2021 Symbol 5.1.7
	Global Trade Identification Number.
	Manufacturer. This symbol is accompanied by the name and address of the manufacturer. ISO 15223-1:2021 Symbol 5.1.1
	CAUTION: Federal (USA) law restricts the sale of this device to or on the order of a licensed physician.
	Do not use if package is damaged. ISO 15223-1:2021 Symbol 5.2.8
	Magnetic Resonance Unsafe. ASTM F2503-13
	Do not incinerate.
	Direct current (Smart Cable USB connection). IEC 60601-1 Table D.1, Symbol 4