CineECG Services Label information
Manufacturer:
ECG Excellence BV
Weijland 38
2415BC NIeuwerbrug
The Netherlands
Intended use:
CineECG Services is software is used to view and print resting 12-lead ECG data. CineECG Services processes 12-lead ECG data to support diagnostics and prognostics for adult persons. The software is intended to be used by a licensed health care practitioner.
CIneECG Services is a medical device according to the European CE-MDR and the FDA. At this moment the intented use is medical investigation.
CineECG Services is not yet certified in any country
Instructions for Use
You can find and download the CineECG Services IFU VS07
Clinical Benefits and clinical performance.
CineECG provides additional information to support the distinction decision of physicians regarding normal or abnormal ECG. CineECG provides standard 12-lead ECG output and complementary ECG information.
This is achieved by relating the ECG data to the cardiac anatomy, deriving median electrical pathways (both atria and ventricular) from the data and by deriving median amplitudes (waves) from the ECG data. Pathways and Waves are compared against a normal distribution of normal performing hearts. The sensitivity and specificity of CineECG is detection abnormalities in QRST is both around 80% with a confidence level of 88%. In its comparison process CineECG is distinct between male, female and all-gender categories if the gender information is part of the ECG data set.
Precaution
CineECG services provides additional views on 12-lead ECG data. The licensed physician must be trained in reading and interpreting 12 lead ECG standard output. A full diagnosis of the condition of a person should always consider additional characteristics of the person which are not part of the ECG data, such as (but not limited to) medical history, other physical characteristics, genetic information.
CineECG Services requires 12-lead resting ECG data presented in a JSON format. 60 seconds length ECG recording optional but CineECG is primed for 10 seconds ECG recording.
The ECG signal quality needs to be sufficient to derive a median beat from the data received in the CineECG system. If the quality of the signal is insufficient in two or more leads the system will only generate a first page (see below). The person or organisation responsible for recording the ECG data is also responsible for the data quality. This includes correctness of leads positioning, conduction quality of electrodes used in the process.
Requirements
The (physical) gender of the patient must be provided with the JSON formatted data in order to deliver gender personalized outcome.
CineECG does not recognize so-called lead switches.
A licensed and trained medical professional is needed to assess the ECG output in order to recognize lead switches.
The current version of CineECG services is 0643
UDI-DI for CineECG services is 78800CineE-01MD
article number for version is 8720299883413