JJF 1392-2013Program of Pattern Evaluation of Ambulatory Electrocardiographs (English PDF)

1 Scope (1)

2 References (1)

3 Overview (1)

4 Legal management requirements (2)

5 Measurement requirements (2)

6 General Requirements (3)

7 Type evaluation item list (4)

8 Type evaluation test methods and conditions (5)

9 Type, Judgment principle results (25)

Appendix A dynamic (movable) ECG machine type evaluation original record format (26)

Introduction

This outline is dynamic (movable) ECG machine type evaluation basis.

The preparation of the outline to JJG1042-2008 "dynamic (movable) ECG machine", GB/T 14710-2009 "Medical electrical environmental requirements and test methods", GB/T 17626.2-2006 "Electromagnetic compatibility - Testing and measurement techniques Electrostatic discharge immunity test ", GB/T 17626.4-2008" Electromagnetic compatibility - Testing and measurement techniques - Electrical fast Transient burst immunity test ", GB/T 17626.5-2008" Electromagnetic compatibility - Testing and measurement techniques - Surge (Impact) immunity test "and GB/T 17626.11-2008" electromagnetic compatibility test and measurement technology voltage sags Drop, short interruptions and voltage variations immunity tests "basis.

This outline is the first release.

Dynamic (movable) ECG machine Type Evaluation Outline

1 Scope

This type of evaluation outline for the following two types of dynamic pattern evaluation (removable) ECG machine.

a) continuous recording, analysis and electrocardiogram achieve full playback. It may be recorded after storage back to the stand-alone workstation Caving or recorded, analyzed simultaneously.

b) continuous analysis but only a part of the record, does not provide full playback.

2. References

This outline references the following documents.

JJG1042-2008 dynamic (movable) ECG machine GB/T 14710-2009 medical electrical environmental requirements and test methods GB/T 17626.2-2006 Electromagnetic compatibility - Testing and measurement techniques - Electrostatic discharge immunity test GB/T 17626.4-2008 Electromagnetic compatibility - Testing and measurement techniques - Electrical fast transient burst immunity test GB/T 17626.5-2008 Electromagnetic compatibility - Testing and measurement techniques - Surge (impact) immunity test GB/T 17626.11-2008 Electromagnetic compatibility Testing and measurement techniques - Voltage dips, short interruptions and voltage Variations immunity tests these documents contain provisions which through reference in this syllabus constitute provisions of this outline. For dated reference documents Members, release date only applies to this outline, however, encourage the parties according to research whether this outline agreement Use the latest versions of these files. For undated references, the latest edition (including all amendments ) Apply to this syllabus.

3 Overview

Dynamic (movable) ECG machine capable of continuously 24h or longer, three-channel recording in the patient's natural state or multi-channel ECG signal by means of a computer for display, analysis and processing, find all kinds of arrhythmia and ST events Segment abnormalities, provide an important basis for clinical diagnosis and treatment.

Dynamic (movable) ECG machine is usually divided into two types.

a) for continuous recording and analytical dynamic (movable) ECG machine

1) Conventional dynamic (movable) ECG machine, the first recorded ECG signal, and then dividing by the individual workstation Analysis process;

2) real-time dynamic (movable) ECG, recorded and analyzed simultaneously.

b) Continuous analysis but some recordable dynamic (movable) ECG machine

1) In the course of the entire ECG only on important events or specific ECG recording;

2) In the whole course of the real ECG recording ECG, but only generates time and amplitude compression formats