Introduction

The SOLO and ADX wearable sensor/patches are single use, disposable, skin-applied ambulatory ECG recorders used for diagnosing cardiac arrythmias and cardiac health during daily activities. They can be used on patients with at least 15 cm anterior axillary line spacing on their anterior chest wall. Either patch can be prescribed for a patient but not used simultaneously. Both SOLO and ADX can store ECG data and download it after removal of the patch from the patient following a recording period of up to 10 days. Neither patch has a temperature, gyroscope or PO2 sensor.

The ECG data from the patches is transferred from the patch’s electronic module after removal from the patient and placement in the smart cable cradle.
From there the data is downloaded to a Windows based PC for analysis, editing and reporting using Cardiac Insight Inc SOLO/ADX software.
Both patches have a button for patients to enter a data flag for an event and data can be processed from either patch, whether it is the 2 electrode-1 lead SOLO or the 3 electrode- multiple lead ADX.
The patches look similar with a button and lights, a Styrofoam cover over a plastic electronic module and extensions for electrodes.
The ADX is slightly larger with 3 extensions for 3 electrodes while the solo has 2 extensions for 2 electrodes.
Both patches require removing the patch from the patient and removing the Styrofoam from the electronic module for the data gathered to be processed.
The electronic module is then placed in the cradle on the Cardiac Insight Inc which is designed to take the SOLO’s electronic module or the thicker module of the ADX.

SOLO is an innovative wearable ECG recorder designed by Cardiac Insight Inc. Solo has two electrodes so it can only record a single ECG lead since more than 2 electrodes are necessary for more than one lead. Solo seamlessly transmits this data via USB after the patch is removed 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.

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 SOLO received FDA approval in 2017 and has since become a trusted choice in the market.

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

Similar to SOLO, the ADX patch transmits data to the Cardiac Insight Inc’s Windows-based software program via USB. However, what sets ADX apart is the additional option of Bluetooth transmission. This means that patients can conveniently transfer data by Bluetooth while the patch is being worn to a smartphone or tablet (Android or Apple OS) equipped with Cardiac Insight Inc’s dedicated APP by simply pressing the button on the ADX. This APP generates an image of 30 seconds of 2 lead ECG data that can be saved on the smartphone or tablet and sent to the patient’s healthcare provider.

Although the ADX patch 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 SOLO and ADX patches offer cutting-edge wearable ambulatory ECG monitoring solutions.
While SOLO focuses on single ECG lead monitoring and does not include extra sensors or Bluetooth capabilities, the ADX takes monitoring to the next level with multiple ECG leads, accelerometer data, and the convenience of Bluetooth data transfer to a smartphone or tablet.
The main differences between the SOLO and ADX are that the ADX takes up more skin area and is thicker, has Bluetooth, has three electrodes and contains an accelerometer while the SOLO only has an ECG sensor and two electrodes but is smaller.

Is there an over reading service or charge for over reading of the report from the SOLO/ADX patches?

No, there is no over reading service available for the SOLO or ADX patch/sensors. The comprehensive report generated by the SOLO/ADX Windows based Cardiac Insight Inc software must be over read in the health providers office. The program is designed for easy editing, approval and transfer to the local EMR system. Extensive editing, though often not required, can be accomplished by the Traceviewer feature which allows for detailed editing and visualization of every recorded and classified beat when necessary.

Can you Over Read the CardiacInsight’s Automated Report in your Office?

Experience with over reading any ambulatory ECG reports from any over reading service or cardiology department should make the answer YES! Just remember that prior reports have usually been over read by non-physicians with less experience than your cardiology training provided. In the average clinical service, 90% of CardiacInsight’s reports can be read by reviewing the initial pdf, then pressing the Edit Dx button as in Figure 7.1 above.

You can make changes there including pressing button options to delete errors in automatic calls of AF (with obvious P waves) or VF (with obvious artifact). The software is designed to be overly sensitive to these possible diagnoses and they will be the most common errors. The other most common error is calling a normal exercise response a SVT. You can then mark the report findings as abnormal, borderline or abnormal and confirm the report.

In a minority of reports, you will find it necessary to Open TraceViewer and have the possibility of further edits or just making conforming the report .

What must the health care provider/technician do to transfer the data from the SOLO or ADX patch?

Both patches require removal from the patient then removal of the Styrofoam from the electronic module for the data to be transferred. The electronic module must be placed in the cradle of the Cardiac Insight Inc smart cable connected to the clinic/office Windows PC. The software does not run on the Apple operating system

What is the SOLO?

Cardiac Insight Inc SOLO is a single ECG lead (i.e., two electrodes) wearable ECG recorder that records digital ECG data and transmits it via USB to a Windows based software marketed by Cardiac insight inc for analysis, editing, report generation and overreading. It does not have any sensor other than the ECG. It does not have an accelerometer or temperature sensor nor does it have Bluetooth or record skin or body temperature. The button pushes are the same as for the ADX patch except they do not activate Bluetooth data transfer since it does not have Bluetooth nor can it access motion, position or step count since it does not have an accelerometer. It was our first patch and was approved by the FDA in 2017.

What is the ADX?

The Cardiac Insight ADX M400 is a multiple ECG lead (i.e., three electrodes that provide 6 leads) wearable ECG/Sensor patch that records digital ECG and accelerometer data and transmits it via USB to Windows-based software developed by Cardiac Insight Inc for analysis, editing, report generation and overreading. It does not have a temperature sensor but it does have an accelerometer that provides motion and position sensing. Button pushes also activate Bluetooth transmission of data to a smartphone or tablet with our Apple or Android APP installed.

What is the Cardiac Insight SOLO/ADX Software Program?

The Cardiac Insight’s Windows-based software is used after transfer of data from the electronic module using a smart cable when the module is inserted into the cradle on the smart cable. The Cardiac Insight’s software does not run on a Apple computer. The program is designed for easy editing, approval and transfer to the local EMR system. Extensive editing, though often not required, can be accomplished by the Traceviewer feature which allows for detailed editing and visualization of every recorded and classified beat when necessary. Final editing of the report is not provided by an outside service but is performed in the clinic or hospital which can charge for this service.

External Defibrillation

The SOLO and ADX wearable patch/sensors must be removed prior to External Cardiac defibrillation.

Avoid using SOLO or ADX wearable patches for patients with the following conditions:

Adhesive or hydrogel allergies, or a family history of skin allergies.
Life-threatening arrhythmias or need for inpatient monitoring or immediate ECG analysis.
Pacemakers or active stimulator devices, as they can disrupt 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.
In combination with external cardiac defibrillators or high frequency surgical equipment or near strong magnetic fields or devices such as MRI.

Clinicians cannot solely rely on ECG analysis for detecting cardiac conditions, as some conditions may not manifest on an ECG or may only be transient. Therefore, to evaluate a patient’s cardiac health, it is imperative to consider their medical history, physical examination, and symptoms.

Clinicians collect, review, interpret, and diagnose ECG data from wearable ambulatory ECG devices to assess patients’ cardiac health and arrythmia risk. Sound clinical judgment is essential in determining the necessity for additional testing, treatment, or specialized care.

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