MyDiagnostick

Zio Patch

Simply holding the MyDiagnostick naturally with both hands makes it initiate a recording of a 1-minute.


Lead-I ECG, which is analyzed for indicators of Atrial Fibrillation.
Upon completion the highly specific and sensitive result is immediately displayed to the user, but remains available for review through accessory software.

Characteristics of the MyDiagnostick allow it to be used according to a medical professional's wishes:

►► as a 'heat-of-the-moment' quick-check
►► an easy and short-duration screening option which is instantly re-usable
►► long-term monitoring in the home-environment

Based on the result indicated by the MyDiagnostick, qualified medical personnel can choose appropriate follow-up actions.
Features
►► Effortless in use, activated by touch
►► Portable and robust
►► No replaceable skin electrodes required
►► 1-minute Lead I ECG recordings at a sampling frequency of 200 Hz
►► Memory capable of holding 130 one-minute ECG recordings & analysis results
►► Automatically retains essential Atrial Fibrillation ECG recordings
►► Autonomous operation for 1200 full measurements, on full charge
Clinical Performance
►► Negative Predictive Value of 99%, Positive Predictive Value of 72%.
►► Sensitivity of 99%, specificity of 97%.
►► Above percentages are determined as follows: weighted average over independent measurements of all below listed studies, floored to full percentage.
This datasheet will be updated if any value deviates more than 2 percentage points from the stated ones due to new significant studies.
►► Tieleman, R. G., Plantinga, Y., Rinkes, D., Bartels, G. L., Posma, J. L., Cator, R., ... & Houben, R. P. (2014). Validation and clinical use of a novel
diagnostic device for screening of atrial fibrillation. Europace, euu057.
►► Vaes, B., Stalpaert, S., Tavernier, K., Thaels, B., Lapeire, D., Mullens, W., & Degryse, J. (2014). The diagnostic accuracy of the MyDiagnostick to
detect atrial fibrillation in primary care. BMC family practice, 15(1), 113.
►► Kaasenbrood, F. (To be published). Sample size: 3269 measurements.

Accessory: MyDiagnostick - Management Studio
This accessory extends the basic diagnostic indication given upon the end of a recording by the MyDiagnostick 1001R, by allowing visualization and storage of ECGs and their corresponding diagnostic Atrial Fibrillation indication.
In this way confirmation of the MyDiagnostick 1001R’s indication is made possible, while the software also supports patient or screening level administration of occurences of Atrial Fibrillation, helping the medical professional manage the collected ECGs.

My Diagnostick

Basic principle
Connect
Retrieve & Preview
Prepare
Re-use
Assign & Store
Analyze & Confirm
Pursue appropriate clinical action