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This regulation is prepared on the basis of JJF 1002-2010 The rules for drafting national metrological verification regulation, JJF 1001-2011General terms in metrology and their definitions and JJJF 1059.1-2012 Evaluation and expression of uncertainty in measurement. This regulation is developed mainly by reference to JJG 760-2003 Electro cardiac monitor and JJG 692-2010 Non-invasive automated sphygmomanometers.
This regulation is issued for the first time.
Verification regulation of multifunction patient monitoring instruments
1 Scope
This regulation is applicable to the initial verification, subsequent verification and in-service inspection of multifunction patient monitoring instruments.
This regulation covers the verification of electrocardio, non-invasive blood pressure, pulse oxygen saturation and end-tidal carbon dioxide. Any monitoring instruments with full or partial monitoring functions shall be verified in accordance with this regulation.
2 Normative references
The following documents are referenced in this verification regulation:
JJG 692 Non-invasive automated sphygmomanometers
JJG 760-2003 Electro cardiac monitor
YY 0601-2009 Medical electrical equipment - Particular requirements for basic safety and essential performance of respiratory gas monitors
For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
3 Terms and meteorological units
3.1
multifunction patient monitoring instrument
instruments capable of real-time monitoring and recording various basic vital sign parameters of patients, generally including electrocardio, non-invasive blood pressure, pulse oxygen saturation, end-tidal carbon dioxide and other more parameters
3.2
electrocardio
the potential of cardiac bioelectricity in each cardiac cycle caused by the successive excitation of pacemakers, atria and ventricles Electrocardio voltage unit: mV; heart rate unit: time/min.
3.3
sinus rhythm
rhythmic activity of the heart caused by electrical impulses from the sinoatrial node The sinoatrial node is a small node on the heart composed of special cells and is the pacemaker of the heart. The heart beats once when the sinoatrial node impulses once
3.4
amplitude-frequency characteristic
the relationship between the voltage amplification factor and the frequency of human electrocardio signals measured by multifunction patient monitoring instrument In order to measure and display electrocardio signals of human body, the multifunction patient monitoring instrument usually has an amplification circuit inside, which has different amplification ability for signals with different frequencies
3.5
blood pressure
the lateral pressure on the vessel wall when blood flows in the vessel Blood pressure unit: kPa (or mmHg), 1 kPa=7.5 mmHg.
3.6
static pressure
pressure that does not change or changes slowly with time, which reflects the performance parameters measured by the internal pressure sensor of the multifunction patient monitoring instrument after inflation, pressurization and stabilization
3.7
diastolic blood pressure
pressure of blood on the vessel wall when the artery retracts elastically during diastole
3.8
systolic blood pressure
pressure of blood on the arterial wall when the blood flows from the ventricle into the artery during systole
3.9
air leakage
sealing performance of air passage used for measuring blood pressure by multifunction patient monitoring instrument The works of the non-invasive blood pressure measurement system of multifunction patient monitoring instrument include the process of pressurizing and depressurizing the cuff. If any leakage in the internal air circuit of the system, the accuracy of blood pressure measurement will be affected. The test for air leakage is mainly to check whether the non-invasive blood pressure measurement system is leaked. By pressurizing the non-invasive blood pressure measurement system to a certain value, cutting off the gas source and keeping the gas circuit closed, and recording the change of the pressure value within a certain time to obtain the parameters of air leakage, usually expressed in pressure leakage rate, kPa/min (or mmHg/min)
3.10
oxygen saturation
percentage of the oxyhemoglobin volume bound by oxygen in blood to the total bound hemoglobin volume, which is generally expressed by SaO2, which can be detected by a blood gas analyzer In clinical monitoring, the oxygen saturation of human body is generally measured by pulse blood oxygen detection equipment, and the estimated value of SaO2 value, i.e. pulse oxygen saturation, is obtained, which is generally expressed by SpO2
3.11
end-tidal carbon dioxide concentration
the concentration of carbon dioxide in exhaled air at the end (peak concentration in exhalation period), which is usually expressed in partial pressure. For example, when the atmospheric pressure is 1 standard atmospheric pressure (760 mmHg), the partial pressure of 5 kPa (or 38 mmHg) end-tidal carbon dioxide is equivalent to 5% by volume of the concentration of carbon dioxide in end-tidal air. At the same time of measuring the end-tidal carbon dioxide concentration, the respiratory frequency, or respiration rate for short, can generally be measured. Unit of end-tidal carbon dioxide concentration: kPa (or mmHg, or %)
4 General
Multifunction patient monitoring instrument (hereinafter referred to as monitoring instrument) is mainly used to monitor vital sign parameters of critically ill patients clinically. For general monitoring instruments, the monitoring parameters include electrocardio, non-invasive blood pressure and pulse oxygen saturation; and for those used in the operating room, the end-tidal carbon dioxide monitoring function shall be equipped.
The monitoring instrument consists of three parts: signal acquisition, signal processing and signal display and output. The signal acquisition includes various sensors and electrocardio electrodes to convert biological signals into measurable electrical signals. The signal processing includes analog processing and digital processing. The signal display and output includes signal display, recording and alarm, such as digital display, waveform display, copy recording, sound-light alarm, etc.
Contents
Introduction i
1 Scope
2 Normative references
3 Terms and meteorological units
4 General
5 Metrological performance requirements
5.1 Error of voltage measurement
5.2 Error of scanning speed
5.3 Amplitude-frequency characteristics
5.4 Indication error of heart rate
5.5 Measurement range of static pressure
5.6 Indication error of static pressure
5.7 Indication repeatability of blood pressure
5.8 Air leakage
5.9 Pulse oxygen saturation
5.10 Pulse rate
5.11 End-tidal carbon dioxide concentration
5.12 Respiratory rate
6 General technical requirements
6.1 Appearance and marking
6.2 Normality of lead work
6.3 Alarm function
6.4 Automatic pressure relief function
7 Control of measuring instruments
7.1 Verification conditions
7.2 Measuring instruments and supporting equipment
7.3 Verification items
7.4 Verification method
7.4.1 Inspection for appearance and working normality
7.4.2 Preparation before verification
7.4.3 Electrocardio
7.4.4 Non-invasive blood pressure
7.4.5 Pulse oxygen saturation
7.4.6 End-tidal carbon dioxide
7.5 Treatment of verification results
7.6 Verification period
Annex A Original verification records of monitoring instrument
Annex B Format of verification certificate and notice of verification result (inside page)
