Ensure a permanent broadband Internet connection at all times of using PMcardio.
Ensure that the system time and date of the phone are not set to the future.
Ensure that you are logged in before attempting to use the device.
Ensure a sufficient amount of credits, active subscription, or availability of organizational profile before use.
Do clean the camera lens of the smartphone before use.
Ensure good lighting conditions when using PMcardio and set the flashlight to automatic mode.
Ensure the correct setting of the paper speed (mm/s) and the voltage gain (mm/mV).
Additional diagnostic investigations other than the ones suggested by the app may be necessary.
PMcardio only detects the diagnoses listed in the section Clinical Safety and Performance in this document. Other diagnoses that are not identified by PMcardio might nevertheless be present.
Complete ALL patient history questions, if more than one diagnosis is detected to ensure accurate patient management/treatment recommendations.
The report has 90 days lifetime, after that it is not possible to edit it anymore.
Powerful Medical makes no warranty for any data or information that is collected erroneously by the device, or misuse or malfunction as a result of abuse, accidents, alteration, misuse, neglect, or failure to update the application as instructed.
DO NOT use PMcardio for analyzing low quality ECG recordings.
DO NOT use PMcardio for analyzing ECGs of patients with an active pacemaker.
DO NOT use PMcardio for analyzing ECGs with flatlines (disconnected leads).
DO NOT use PMcardio for analyzing exercise stress test ECG recordings.
DO NOT use PMcardio for analyzing ambulatory/Holter ECG recordings.
The diagnostic confidence levels for each diagnosis shall be interpreted as follows: a. Low confidence: PMcardio is slightly more confident that the patient has the diagnosis than that the patient does not have it. b. Medium confidence: PMcardio is more confident that the patient has the diagnosis than that the patient does not have it. c. High confidence: PMcardio is confident that the patient has the diagnosis.
Selecting incorrect answers to anamnestic questions may result in under- or overdiagnosis or under- or overtreatment of a patient.
After ECG analysis, the app may incorrectly identify cardiovascular conditions.
Powerful Medical does not guarantee that the patient is not experiencing a cardiovascular event, abnormal rhythm or other health conditions when no serious diagnoses are detected.
The overall average values of the ECG intervals may be inaccurate for ECG recordings of low quality.
It is the user's responsibility to restrict access to the application for persons other than the logged-in user.
The user must give PMcardio access to their smartphone camera to create a report.
The user must give PMcardio access to their push-notifications and deactivate “no disturb”-mode to receive notifications.
PMcardio is unable to identify inverted leads.
Should the confidence statement indicate 'Low confidence', it's recommended to repeat the ECG and scan the new ECG.
The OMI diagnosis does not encompass detection of chronic total occlusions as a culprit for present symptoms.
The OMI diagnosis does not encompass all types of acute myocardial infarctions, it only encompass myocardial infarction of a culprit artery with an occlusive or flow limiting lesion.