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JJG 1163-2019 English PDF

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JJG 1163-2019: Multifunction Patient Monitoring Instruments
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Standard similar to JJG 1163-2019

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Basic data

Standard ID JJG 1163-2019 (JJG1163-2019)
Description (Translated English) Multifunction Patient Monitoring Instruments
Sector / Industry Metrology & Measurement Industry Standard
Classification of Chinese Standard A50
Classification of International Standard 17.020
Word Count Estimation 21,235
Date of Issue 2019
Date of Implementation 2020-03-31
Issuing agency(ies) State Administration for Market Regulation

JJG 1163-2019: Multifunction Patient Monitoring Instruments

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Multifunction Patient Monitoring Instruments National Measurement Verification Regulations of the People's Republic of China Multi-parameter monitor Published on December 31,.2019 2020-03-31 Implementation Issued by the State Administration of Market Supervision and Administration Verification Regulations of Multi-parameter Monitor Centralized unit. National Medical Metrology Technical Committee Main drafting unit. China Academy of Metrology Chinese People's Liberation Army Joint Logistics Support Force Drug Instrument Inspection Institute Participated in the drafting unit. Inner Mongolia Autonomous Region Metrology and Testing Institute Beijing Academy of Metrology and Testing Science Shandong Institute of Metrology The National Medical Metrology Technical Commission is responsible for the interpretation of this regulation The main drafters of this regulation. Liu Wenli (Chinese Academy of Metrology) Hu Zhixiong (Chinese Academy of Metrology) Jia Jiange (Chinese People's Liberation Army Joint Logistics Support Force Pharmaceutical Instrument Inspection Institute) Participating drafters. Ningquan (Inner Mongolia Autonomous Region Metrology and Testing Institute) Gao Yang (Beijing Institute of Metrology and Testing Science) Xiaowen Qin (Shandong Institute of Metrology)

table of Contents

Introduction (Ⅱ) 1 Scope (1) 2 References (1) 3 Terms and units of measurement (1) 4 Overview (2) 5 Measurement performance requirements (2) 5.1 Voltage measurement error (2) 5.2 Scanning speed error (2) 5.3 Amplitude-frequency characteristics (3) 5.4 Heart rate indication error (3) 5.5 Static pressure measurement range (3) 5.6 Indication error of static pressure (3) 5.7 Repeatability of blood pressure indication (3) 5.8 Airtightness (3) 5.9 Pulse oximetry (3) 5.10 Pulse rate (3) 5.11 CO2 concentration at the end of call (3) 5.12 Respiration rate (3) 6 General technical requirements (3) 6.1 Appearance and signs (3) 6.2 The normal operation of the lead (3) 6.3 Alarm function (3) 6.4 Automatic pressure relief function (3) 7 Control of measuring instruments (4) 7.1 Verification conditions (4) 7.2 Measuring instruments and supporting equipment (4) 7.3 Verification items (5) 7.4 Verification method (5) 7.4.1 Appearance and work normality inspection (5) 7.4.2 Preparation before verification (5) 7.4.3 ECG (5) 7.4.4 Non-invasive blood pressure (7) 7.4.5 Pulse oximetry (8) 7.4.6 Exhaled carbon dioxide (9) 7.5 Processing of verification results (10) 7.6 Verification period (10) Appendix A. Original Records of Monitor Verification (11) Appendix B Format of the inner pages of the verification certificate and verification result notice (14)

Introduction

The preparation of this regulation is based on JJF1002-2010 "Rules for Compiling National Measurement Verification Regulations", JJF1001-2011 "General Measurement Terms and Definitions" and JJF1059.1-2012 "Measurement Uncertainty Evaluation and Expression" as the basis. this The procedure mainly refers to JJG 760-2003 "ECG Monitor" and JJG 692-2010 "Non-invasive automatic blood pressure measurement" meter". This regulation is issued for the first time. Verification Regulations of Multi-parameter Monitor

1 Scope

This regulation is applicable to the first verification, subsequent verification and in-use inspection of multi-parameter monitors. This procedure covers the testing of four major parameters. electrocardiogram, non-invasive blood pressure, pulse oximetry, and end-carbon dioxide. Any monitor measurement verification with all or part of the monitoring function shall be carried out in accordance with this regulation.

2 Reference documents

This verification procedure refers to the following documents. JJG 692 Noninvasive Automatic Blood Pressure Monitor JJG 760-2003 ECG monitor YY0601-2009 Special requirements for basic safety and main performance of medical electrical equipment respiratory gas monitor For dated references, only the dated versions are applicable to this Regulation; for those without dates The latest version (including all amendments) is applicable to this regulation.

3 Terms and units of measurement

3.1 Multifunction patient monitoringinstrument Instruments that can monitor and record various basic vital signs parameters of patients in real time, generally including ECG, Non-invasive blood pressure, pulse oximetry and end-tidal carbon dioxide etc. or more parameters. 3.2 ECG electrocardio In every cardiac cycle of the heart, the cardiac bioelectric potential caused by the successive excitation of the pacing point, atrium, and ventricle. heart Unit of electrical voltage. millivolt, symbol. mV; unit of heart rate. beats/min. 3.3 Sinus rhythm sinusrhythm Heart rhythmic activity caused by electrical impulses from the sinus node of the heart. Sinus node is a heart made of special cells The small nodules on the viscera are the pacing points of the heart. The heart beats every time an impulse occurs in the sinoatrial node. 3.4 Amplitude-frequencycharacteristic The multi-parameter monitor measures the relationship between the voltage magnification and frequency of the human ECG signal. For measurement and display The electrocardiographic signal of the human body, the multi-parameter monitor generally has an amplifier circuit, and the amplifier circuit amplifies signals of different frequencies Capabilities may vary. 3.5 Blood pressure The side pressure on the blood vessel wall when blood flows in the blood vessel. Blood pressure unit. kPa (or mm Hg), symbol No.. kPa (or mmHg), 1kPa = 7.5mmHg. 3.6 Static pressure Pressure that does not change with time or changes slowly with time. Static pressure reflects the pressure after inflation and stabilization The internal pressure sensor of the multi-parameter monitor measures performance parameters.

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