ISO 41064:2023 健康情報学 - 標準通信プロトコル - コンピュータ支援心電図検査 | ページ 6

3.1

acquiring cardiograph/ acquiring device

cardiograph/device recording the original ECG signal

3.2

analysis Time Window

defines the time interval (starting date and time and duration) that will be used to select an ECG excerpt that will be analysed by a computer program and/or by a health professional viz a cardiologist

3.3

confirming

process whereby a trained and experienced health professional signs off the stored interpretation report and/or the stored measurement values and annotations of an ECG in order to confirm the computer-generated (or already overread) interpretation report and/or measurement values and annotations

Note 1 to entry: The confirmed ECG interpretation report is the final clinically acceptable version for diagnosis and treatment

3.4

CSE Project

project supported by DG XII of the European Commission aiming at the development of Common Standards for (Quantitative) Electrocardiography (see references [32] and [44] to [50])

3.5

ECG excerpt

portion of a continuous ECG recording that has been either visually selected by a health professional or by a computer based algorithm or according to a predefined protocol (viz a 10 s excerpt every hour)

3.6

interpretive device

device (cardiograph, wearable equipment, smartphone, computer, cloud, etc.) analysing and interpreting the ECG signal

3.7

message

textual body of information

3.8

overreading

process whereby a fully trained cardiologist, or a physician of equivalent standing with cardiology training, reviews the computer-generated interpretation and/or some of the measurement values and annotations of an ECG in order to detect any obvious errors, including those of omission, and hence makes changes to the text of the report and/or to the measurement values and annotations

Note 1 to entry: In some clinical settings, the process of overreading is performed in two steps. The ECG is first over-read by a less skilled health professional, e.g. a cardiologist trainee, and is then over-read and confirmed by a fully trained cardiologist.

Note 2 to entry: If an over-read of an ECG interpretation report is signed off (i.e. confirmed, see Clause 3.3) by the over-reader, then it should be clinically acceptable for diagnosis and treatment.

Note 3 to entry: It should be remembered that an over-reader provides a personal opinion in either verifying or altering a computer generated interpretation and/or measurement or annotation. One over-reader may disagree with another in the same way as one medical professional may disagree with another in making a clinical diagnosis.

3.9

record

entire data file which is transmitted, including the ECG data and associated information, such as patient identification, demographic and other clinical data, measurements, annotations, interpretation results, etc.

3.10

reference beat

reference/representative ECG cycle computed through any (but not specified) algorithm comprising the P, QRS and the ST-T waves

3.11

rhythm data

full original ECG data, or the decompressed and reconstructed ECG data if lossless compression is used

Note 1 to entry: Rhythm data are typically 10 s in length for a standard 12-Lead ECG (stored in sections 6 and/or 14), but may last several minutes for stress tests, a few hours for drug trials and up to 7 days for Holter recordings (stored in section 12).

3.12

section

aggregate of data elements related to one aspect of the electrocardiographic recording, measurement, annotation or interpretation

3.13

universal statement codes

ECG interpretation codes described in Annex B of this document

Note 1 to entry: See glossary in Annex G for other technical terms related to this part of EN 1064.