CineECG Services Label information
Manufacturer:
ECG Excellence BV
Weijland 38
2415BC NIeuwerbrug
The Netherlands
Intended use:
CineECG Services is software which requires 12-lead ECG data for input and delivers a report containing multiple views of the ECG data as output. CineECG Services processes 12-lead ECG data by relating 12 lead ECG data to the heart anatomy to derive electrical pathway. Both pathways and ECG waveform values are compared with a normal distribution of normal classified ECGs. With the purpose of assisting a licensed health care practitioner in making an assessment for adult persons if the heart ventricular ECG is within a normal range.
Medical Device
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 CineECG Services Instructions for use here:
Instructions for use can also be obtained in paper form by sending a request to info@cineecg.com with your client number and adress. We will make sure to provide a hardcopy via postmail within 7 calendar days after receiving the request.
Clinical Benefits and clinical performance.
CineECG provides additional information to support the physisian by classifying the provided ECG as normal or abnormal. CineECG provides standard 12-lead ECG output and complementary ECG information to visualise the normal/abnormal classification.
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.
Precautions
- The user of CineECG must be a licensed physician, trained in reading and interpreting 12 lead ECG standard output. CineECG does support by classifying the ECG, but does not make the decision for a physisian.
- CineECG compares ECG’s with a database with adult ECG’s. Therefore, CineECG should not be used for patients under 18 years old.
- 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 user should not rely on the lack of a suspected finding to rule out other follow-up procedures. 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 does only classify ECG waveforms from a median beat. This means it only analyses the most frequent presented waveform beat and thereby does not analyse single deviating beats (for instance: PVC’s)
- If no median beat can be created, only the first page is provided and no waveform analysis is done. This might happen with noisy data.
Requirements
The (Biological) sex of the patient must be provided in order to deliver sex-specific analysis.
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.
CineECG Services requires digital 12-lead resting ECG data between 10 and 60 seconds length. CineECG will only provide a 10 seconds rhythm view of the provided ECG data.
The current version of CineECG services is 2.0.0.67
UDI-DI for CineECG services is 78800CineE-01MD
article number for version is 8720299883413