YY 0784-2010Medical electrical equipment—Particular requirements for the basic safety and essential performance of pulse oximeter equipement for medical use (English PDF)

3.1 Accuracy

The degree of agreement between the test results and the accepted reference values.

Note 1. see 50.101.2.2 pulse oximeter equipment, the accuracy of the calculation method.

Note 2. See also Appendix CC for discussion.

Note 3. quoted from GB/T 3358.1.

3.2 Controlled hypoxia saturation control

controldesdesurationuration In the laboratory conditions for the human body induced by hypoxia.

Note: Also known as controlled hypoxia (respiratory limitation) studies. See Annex EE.

3.3 Carbon monoxide - Blood gas analyzer CO-oximeter

Multi-wavelength, optical blood gas analyzer, can measure the total hemoglobin concentration and a variety of hemoglobin derivatives concentration.

Note: The carbon monoxide-blood gas analyzer-related measurements are functional saturation of the arterial blood, ie SaO2, while the pulse oximetry is estimated and reported to SpO2.

3.4 Data update period

The algorithm of the pulse oximeter device provides a time interval for new valid data to the display or signal output port.

Note: This definition does not refer to the displayed refresh period, and the typical value of the display refresh period is 1s, not the time interval defined above (generally longer).

3.5 Claim scope

Refers to the pulse oxygen saturation (SpO2) and the pulse rate value of the display range (3.7) in the clear part of the accuracy.

3.6 Demonstration mode

A pattern that shows simulated patient data or patient waveforms.

Note: If there is no proper indication, the data displayed in the demo mode may be mistaken for the patient's real-time recording data.

3.7 Display range displayed range

The pulse oximetry device can display the range of pulse oximetry (SpO2) and pulse rate values.

Note: This range can exceed the claimed range (3.5).

3.8 Partial saturation

FO2Hb Oxygenated hemoglobin concentration cO2Hb and hemoglobin total concentration ctHb ratio.

Note 1. expressed as a mathematical expression. FO2Hb = cO2HbctHb Where.

CO2Hb - oxygenated hemoglobin concentration; CtHb --- total hemoglobin concentration. This formula sometimes appears as a percentage (multiplied by 100).

Note 2. Partial oxycyclotin is a term used by the National Committee for Clinical Laboratory Science (NCCLS) for this ratio.

Note 3. NCCLS uses the prefix c to denote "concentration", which was used in square brackets, such as [O2Hb].

Note 4. NCCLS uses the following symbols. Oxygenated hemoglobin (O2Hb);

--- deoxyhemoglobin (HHb);

--- carboxyhemoglobin (COHb); Methemoglobin (MetHb);

--- sulfur hemoglobin (SuHb); The total amount of hemoglobin (tHb).

3.9 Functional oxygen saturation

Oxygenated hemoglobin concentration divided by the sum of the oxygenated hemoglobin concentration and the deoxyhemoglobin concentration.

Note 1. expressed as a mathematical expression.

100 cO2Hb CO2Hb cHHb

Note 2. NCCLS defines this ratio as functional oxygen saturation, symbolic representation of SO2.

3.10 Functional tester

Providing a signal with a predictive ratio (3.22) for the pulse oximeter device so that the tester can observe the display of blood oxygen values, And a test device that compares the expectations on the calibration curve developed by the manufacturer for this oximeter device.

Note: The pulse oximeter device provides the accuracy of the oxygen value in a certain procedure depending on whether the blood oxygen monitor's calibration curve is compared with the oxygen probe and probe- The optical properties of the interaction of the interface are consistent. Functional test instrument can not prove the calibration curve of blood oxygen accuracy, can not fully assess blood oxygen The optical characteristics of the probe to determine the correctness of the calibration. See also chapter FF.4.

3.11 Local deviation

localbias The difference between the oxygen test value (SpO2) and the accepted reference value (SaO2).

Note 1. For pulse oximeter devices, this means that for a given reference value for oxygen saturation, the corresponding y value on the regression curve is proportional to the relative The difference between the corresponding y values on the equivalent curve of the multiple oxygen measurements of SR, or expressed as. Bi = SpO2fit, i-SRi Where.

SpO2fit, i - The value corresponding to the i-th oxygen saturation reference value SRi on the test data fitting curve.

Note 2. See also the mean deviation (3.13) and the discussion in Appendix CC.

Note 3. cited in ISO 3534-1.:1993.

3.12 Manufacturer

The design, production, packaging, and application of the pulse oximeter device, the oxygen monitor, the oxygen probe, the probe extension cord or the adapter Work, sale and the preparation of random documents are responsible for the natural or legal person, whether these operations are completed by their own or by the benefit The third party of the relationship is completed.

Note: quoted from IEC /CDV260601-1..2004, defined 3.54.

3.13 Mean difference

meanbias The mean difference between the test value and the reference value, leaving the symbol.

Note 1. For pulse oximeters, a mathematical expression is described as. (SpO2i-SRi) Where.

N - the number of samples in the area of interest; SpO2i --- ith pulse oxygen saturation value; SRi --- reference value for the i-th oxygen saturation.

Note 2. See also discussion of local deviations (3.11) and Appendix CC.

Note 3. When this method is used, this mean difference is the average of all local deviations.

3.14 Normalized

Does not depend on the actual amplitude of the displayed signal, but is displayed at the same amplitude.

3.15 Operator settings

Operatorettings The current status of any control item of the pulse oximeter, including the alarm setting item.

3.16 Precision

The degree of agreement between the independent test results obtained under the specified conditions.

Note 1. For pulse oximeter equipment, it can be expressed as the remaining standard deviation, ie Sres, described as a mathematical expression. (SpO2i-SpO2fit, i) 2 (N-2) Where.

N - the number of data pairs in the area of interest;

(SpO2i-SpO2fit, i) is the difference between the i-th SpO2 value and the value on the fitting curve (corresponding to the ith reference saturation value).

Note 2. See also Appendix CC for discussion.

Note 3. cited in ISO 3534-1.:1993.

3.17 Probe cable extension cord

probecableextender Used to connect the pulse oximeter to the oxygen probe.

Note 1. Not every pulse oximeter device uses a cable extension cable for the probe.

Note 2. The probe cable extension cord can be used as part of the application.

3.18 Pulse oximetry device

pulseoximeterequipment The pulse oximeter device is the interaction between the optical signal and the tissue and the use of pulsating blood flow to cause tissue optical properties to depend on, A non-invasive medical device for estimating arterial oxygen saturation (SpO2).

Note 1. The pulse oximeter device includes a pulse oximetry monitor, a probe extension cable (if provided), and a blood oxygen probe, where the cable extends Long lines and blood oxygen probes can be combined into a single component.

Note 2. Technically, the light here can be seen as electromagnetic radiation (optical radiation). This standard uses generic terms.

3.19 Pulse oximetry

Is part of the pulse oximeter device, including electronic components, display unit and user interface. Does not include pulse oximetry and probe extension cord.

Is part of the pulse oximeter device, including electronic components, display unit and user interface. Does not include pulse oximetry and probe extension cord.

Note: The pulse oximeter may consist of hardware that is scattered at multiple locations, for example, where the application part and the primary display part of a telemetry system are not The same physical location.

3.20 Pulse oximetry

pulseoximeterprobe Is part of the pulse oximeter device, including the application of components and sensor components.

Note 1. Termaneous sensors and transducers are also used in pulse oximetry probes.

Note 2. The pulse oximeter usually contains a cable, as well as a hard or soft component that includes two transmitters and a receiving tube.

3.21 Pulse oximeter probe fault

Pulse oximetry or probe cable extension cord abnormal condition, if not detected, will endanger the safety of patients.

Note: Providing an incorrect value, so that the patient's exposure to the probe's high temperature or the risk of introducing current shocks may compromise the safety of the patient.

3.22 Ratio

Modulation ratio Ratio ratio Is the basic amount of the pulse oximeter device derived from the measured light intensity over time.

Note: The pulse oximeter device uses an experimentally proven calibration curve and derives SpO2 from the R value. See also FF.4.

3.24 Arterial oxygen saturation SaO2

Arterial blood with oxygen - bound function hemoglobin fraction.

Note 1. Refer to the requirements of the acceptable SaO2 measurement method in 50.101.2.2.

Note 2. SaO2 is functional oxygen saturation in arterial blood (see 3.9).

Note 3. usually expressed as a percentage (score multiplied by 100).

3.25 Pulse Oxygen Saturation

Estimated values for SaO2 by pulse oximeter equipment.

Note 1. Dual-wavelength pulse oximetry equipment in the estimation of SaO2, and can not compensate for the presence of lesions caused by the interference of hemoglobin.

Note 2. usually expressed as a percentage (score multiplied by 100).

3.26 Total hemoglobin concentration

totalhaemoglobinconcentration CtHb The sum of all concentrations of hemoglobin, including, but not limited to, the concentration of oxyhemoglobin (cO2Hb), methemoglobin Concentration (cMetHb), deoxyhemoglobin concentration (cHHb), thiomaloglobin concentration (cSuHb) and carboxyhemoglobin concentration (cCOHb).

Note: See also references [16].

4.101 Other test methods

If the method that can be obtained is equivalent to what is defined in this standard in terms of safety class and performance, the manufacturer may use the same Standard details of different types of test methods, when there is a dispute, the method declared here should be used as a reference method.

4.102 Acceptable criteria

In terms of performance, many of the test items in this standard establish acceptable criteria. These acceptable criteria should always be met.

When the manufacturer claims that the performance level in the random file is superior to the requirements specified in this standard, the manufacturer's claimed performance Acceptable criteria.

For example. For a 1% SpO2 accuracy claim, for all requirements, such as in the EMC (Electromagnetic Compatibility) test, Stroke oxygen meter can achieve 1% SpO2 accuracy.

4.103 Pulse oximeter equipment, parts and accessories

Pulse oximetry equipment, and all individual components and accessories that are claimed to be used on the device, as well as the manufacturer's claim to be used for this All combinations of components or accessories of the pulse oximeter device shall comply with all the requirements specified in this standard.

Note 1. This requirement, combined with the expected pulse oximetry, is intended to ensure that the basic safety of the accessories and components of the pulse oximeter device and the main To performance.

Note 2. Pulse oximetry monitors are frequently used with some pulse oximetry and extension cord from different manufacturers. This requirement ensures that such groups Compatibility.

All combinations of claims for the pulse oximeter device, as well as individual components and accessories for all pulse oximetry devices, should be used

Note in the book. See also 6.8.2aa) 11) and 6.8.2aa) 12).