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.

 

 

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 downloadCineECG Services IFU VS08

In case this does not work or you would like to receive a hardcopy of the Instructions for Use through email or regular mail please send a request to info@cineecg.com

 

 

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