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
