Calibration device and method for percutaneous partial pressure monitor
Technical Field
The invention relates to the technical field of blood gas analysis, in particular to a calibration device and a calibration method for a percutaneous partial pressure monitor.
Background
Blood gas analysisThe blood gas monitoring of medium oxygen partial pressure and carbon dioxide partial pressure is very necessary, and arterial blood needs to be repeatedly collected for blood gas analysis for achieving the purpose. Because blood sampling is an invasive operation, adverse stimulation and infection increasing opportunities are brought to patients, and iatrogenic anemia can be caused by multiple times of blood sampling. Transcutaneous oxygen partial pressure (TcPO)2) Can effectively reflect capillary nutrition blood flow and percutaneous carbon dioxide partial pressure (TcPCO)2) Can reflect the change of the ventilation state of the patient, reflects the average value of the alveolar carbon dioxide partial pressure, and the value of the alveolar carbon dioxide partial pressure influences the pH value of the blood. Thus, the value of the measured value can reflect the adjusting capacity of the respiratory function on the acid-base balance.
Today TcPO2And TcPCO2Has become a clinical common examination index for wound treatment evaluation, hyperbaric oxygen medicine, amputation height judgment and the like. The application of transcutaneous oxygen partial pressure monitoring began in 1966 abroad and Evans et al first achieved direct contact with the surface of the skin via electrodes for skin oxygen partial pressure measurement. Huch and Eberhard use electrode heating to measure "arterial blood oxygen" percutaneously; during the 70's of the 20 th century, Tonnesen first reported the application of TcPO2 technology to the diagnosis of vascular disease of the lower extremities. At present, with the wide application and increasingly intensive research of TcPO2, TcPO2 is gradually accepted by more and more clinicians as a detection method for judging the actual oxygen supply of tissues, relieves pain of patients and has certain clinical application value.
The rationale for the determination is according to faraday's law: the current flowing through the analyzer electrode is proportional to the oxygen partial pressure, and the current and oxygen concentration are in a linear relationship with the temperature being constant. Heating the monitored epidermis via the electrodes to allow oxygen in the epidermis and subcutaneous tissues and associated capillaries to be transferred to the electrodes via diffusion and the like from the TcPO2The monitor measures its oxygen partial pressure. The application method comprises three steps. Firstly, preparing skin, disinfecting the skin, wiping off grease and cleaning hair; secondly, attaching a fixing ring; thirdly, dripping 3-5 drops of contact liquid in the fixing ring, aligning an arrow on the motor with the protruding part of the fixing ring, putting the motor into the fixing ring, and rotating the motor clockwise by 90 degrees to fix the motor. When the detection is started, the motor is heated to make the local capillary vessel moveThe pulse is generated, and the contact solution dissolves the lipid on the skin surface to disperse the gas on the skin surface. The gas is captured by the sensor and converted into reading for presentation through calculation.
In the prior art, the related standard of the current percutaneous partial pressure monitor comprises IEC 60601-2-23-2011 medical electrical equipment, parts 2-23, detailed requirements on basic safety and essential performance of percutaneous partial pressure monitoring equipment, and the requirements on the basic safety and main performance of the percutaneous partial pressure monitoring equipment are stipulated. Wherein temperature and partial pressure are the key detection parameters. During measurement, monitor electrodes are placed in a measurement air chamber, and standard gases with different concentrations are input into the measurement air chamber through a ventilation pipeline. The electrode is used for measuring the measured values obtained by the standard gases with different concentrations, and whether the nonlinearity of the measured values meets the requirements is calculated, so that the detection of the electrode partial pressure parameters of the monitor is completed.
The prior art has the defect that the temperature part, IEC 60601-2-23-2011 medical electrical equipment, parts 2-23, detailed requirements of basic safety and necessary performance of the transcutaneous partial pressure monitoring equipment are only theoretically measurement schemes for the electrode temperature. In fact, the way of manually pressing the reading has a great disadvantage because long-term measurement of more than 30min is required. The partial pressure part, IEC 60601-2-23-2011 medical electrical equipment, parts 2-23, the detailed requirements of basic safety and necessary performance of percutaneous partial pressure monitoring equipment, completes the detection on the aspect of electrodes by measuring standard gases with different concentrations, and has 2 main problems.
One is that the gas temperature should be measured at two points selected near the temperature at which the monitor is used, e.g., at 37 c and 43 c. And the current IEC standard measurement method lacks a standard gas temperature control part. Secondly, according to the method, the gas with different concentration standards is measured, and the detection is completed by calculating the nonlinearity of the measured value, but the accuracy of the numerical value cannot be judged.
Disclosure of Invention
The invention aims to solve the technical problems at least to a certain extent, and provides a calibration device and a calibration method for a percutaneous partial pressure monitor, which can provide technical support for ensuring the normal operation of the monitor, effectively evaluate the metering characteristics of the monitor and finish the metering calibration of the monitor.
The technical scheme of the invention is as follows: the calibration device of the percutaneous partial pressure monitor comprises a temperature measuring mechanism for measuring electrodes of a measured instrument and calculating and storing data;
the device also comprises a partial pressure monitoring mechanism which is used for heating different standard gases in turn, recording the measurement data result of the tested equipment and analyzing.
According to the invention, calibration research of the percutaneous partial pressure monitor is completed, technical support is provided for ensuring normal operation of the percutaneous partial pressure monitor, the metering characteristics of the percutaneous partial pressure monitor are effectively evaluated, and metering calibration of the percutaneous partial pressure monitor is completed. The performance and important parameter indexes of the percutaneous partial pressure monitor are analyzed, and finally, a set of calibration method and calibration device for the percutaneous partial pressure monitor is developed, and the calibration and measurement can be carried out on the percutaneous partial pressure oxygen monitor or the percutaneous carbon dioxide monitor respectively.
Furthermore, the temperature measuring mechanism comprises a sensor and a foam material layer arranged on the sensor, a fixing mechanism for fixing the electrode of the measured instrument is arranged on the foam material layer, and a hole with a size which is consistent with that of the foam material layer is arranged on the foam material layer so that the sensor can be in contact measurement with the electrode of the measured instrument; the sensor is also connected with an external computer. The fixing mechanism comprises a fixing ring and a fixing clamp, the fixing ring is arranged on the foam material layer and is limited to the lower part of the electrode of the measured instrument, the fixing clamp is arranged on the foam material layer and is of a 7-shaped structure, and the fixing clamp is limited to the upper part of the electrode of the measured instrument. The surface of the sensor is also provided with a temperature display screen, and the sensor is a temperature sensor.
In the invention, the temperature measuring mechanism is a special temperature measuring device. The fixed ring and the fixed clamp of the mechanism fix the electrode probe of the measured instrument, the measured equipment and the temperature sensor are connected, the temperature sensor uses the high-precision platinum resistance sensor to measure the temperature of the electrode probe of the measured instrument, and the temperature data is collected and transmitted to the computer. And finally, the computer uses a self-developed temperature calibration system to perform data calculation and storage on the data.
Furthermore, the partial pressure monitoring mechanism comprises a standard gas cylinder, a gas heater, a pipeline and a mixed gas chamber which are connected in sequence. The side part of the mixing air chamber is provided with a fixed port, and the mixing air chamber is connected with the pipeline through the fixed port. And a pressure gauge is arranged at the upper part of the mixing air chamber. The calibration device is externally provided with an empty box barometer for measuring the current air pressure value.
In the invention, the electrode of the equipment to be tested is arranged in the mixing air chamber, different standard gases are heated in turn and are introduced into the mixing air chamber, and the measurement data result of the equipment to be tested is recorded and analyzed. The gas cylinder is specially used for customizing standard gases with different concentrations. The gas heater adopts a medical heater to heat the gas in the pipeline, and can adjust the standard gas to reach the use temperature.
A method of calibrating a device using a transcutaneous partial pressure monitor, comprising the steps of:
s1, measuring a partial pressure monitoring mechanism, namely evaluating the accuracy of a partial pressure value of a percutaneous partial pressure monitor by measuring indication errors and nonlinearity of oxygen partial pressure/carbon dioxide partial pressure values of various standard gases;
s2, electrodes of the instrument to be measured are placed into a temperature measuring mechanism to be fixed, the temperature of the percutaneous partial pressure monitor is set, the percutaneous partial pressure monitor is enabled to work normally and be preheated, the temperature measuring mechanism starts to work after the temperature is stable, and the measured temperature is continuously recorded; and calculating the difference between the maximum temperature and the control temperature and the temperature fluctuation degree to finish the evaluation of the temperature performance of the percutaneous partial pressure monitor.
In step S1, the specific steps are:
A. the metabolic correction factor and severinghau temperature correction factor are set to "0" and "off" respectively in the setting; fixing the electrode of the percutaneous partial pressure monitor in the mixed gas chamber;
B. heating standard gas to 37 ℃ by a gas heater, introducing the standard gas into a mixed gas chamber, after 10min of stabilization time, respectively reading the numerical value of a percutaneous partial pressure monitor by using standard gas 1, standard gas 2 and standard gas 1, and simultaneously measuring the real-time pressure value in the mixed gas chamber by using a pressure gauge and an empty box barometer;
C. real-time pressure values measured by a pressure gauge and an empty box barometer are used for calculating a partial pressure value in the mixed gas chamber, and the partial pressure value is compared with a value of a percutaneous partial pressure monitor to calculate a value indicating error;
in the formula: p
Press and press-the sum of the indication values of the empty-box barometer and the standard pressure meter;
-the pressure gauge is an arithmetic mean of 3 readings; p
Air conditioner-a barometric pressure indication value.
In the formula: Δ P-partial pressure indicating error;
-the transcutaneous partial pressure monitor shows a 3-fold arithmetic mean; p
Press and press-the sum of the pressure gauge and the pressure gauge indication; c-Standard gas concentration.
D. Respectively reading the numerical values of the monitor by using standard gases 1, 2 and 1, and calculating the nonlinearity of the percutaneous partial pressure monitor by judging whether the reading meets the requirement or not;
E. then, heating the standard gas to 43 ℃ by using a gas heater, introducing the standard gas into a mixed gas chamber, and measuring and calculating according to the step C, D after a period of stable time;
in the step S2, the temperature of the percutaneous partial pressure monitor is set to be 45 ℃, and the measured temperature is recorded for 30 min.
Compared with the prior art, the beneficial effects are: the invention provides a calibration device and a calibration method for a transcutaneous partial pressure monitor, and develops a corresponding standard instrument, so that the transcutaneous partial pressure monitor can effectively trace the measurement characteristic. The calibration work of the percutaneous partial pressure monitor is completed, the normal operation of the instrument is guaranteed, and the occurrence of medical accidents is effectively reduced. The portable instrument calibrator is convenient and portable, and can be brought into a hospital by a calibrator to complete instrument calibration.
Drawings
FIG. 1 is a schematic view of the temperature measuring mechanism of the present invention.
Fig. 2 is a schematic structural view of a partial pressure monitoring mechanism of the present invention.
FIG. 3 is a schematic view of a calibration electrode of the present invention.
FIG. 4 is a schematic view of a calibration electrode connection retaining ring of the present invention.
FIG. 5 is a schematic view of the calibration of the inventive calibration electrode connected to a mixing gas chamber.
Fig. 6 is a schematic flow chart of the present invention.
Detailed Description
The drawings are for illustrative purposes only and are not to be construed as limiting the patent; for the purpose of better illustrating the embodiments, certain features of the drawings may be omitted, enlarged or reduced, and do not represent the size of an actual product; it will be understood by those skilled in the art that certain well-known structures in the drawings and descriptions thereof may be omitted. The positional relationships depicted in the drawings are for illustrative purposes only and are not to be construed as limiting the present patent.
The same or similar reference numerals in the drawings of the embodiments of the present invention correspond to the same or similar components; in the description of the present invention, it should be understood that if there is an orientation or positional relationship indicated by the terms "upper", "lower", "left", "right", etc. based on the orientation or positional relationship shown in the drawings, it is only for convenience of describing the present invention and simplifying the description, but it is not intended to indicate or imply that the referred device or element must have a specific orientation, be constructed in a specific orientation, and be operated, and therefore, the terms describing the positional relationship in the drawings are only used for illustrative purposes and are not to be construed as limiting the present patent, and the specific meaning of the terms may be understood by those skilled in the art according to specific circumstances.
As shown in fig. 1 and 2, the calibration device for the transcutaneous partial pressure monitor is characterized by comprising a temperature measuring mechanism for measuring electrodes of the measured instrument and storing data, calculation and storage; fig. 1 shows a temperature measuring mechanism.
The device also comprises a partial pressure monitoring mechanism which is used for heating and mixing different standard gases in turn, recording the measurement data result of the tested equipment and analyzing; fig. 2 is a partial pressure monitoring mechanism.
As shown in FIG. 1, the temperature measuring mechanism includes a sensor 4, a foam layer 3 disposed on the sensor 4, a fixing mechanism for fixing the electrode of the measured instrument is disposed on the foam layer 3, and a hole with a size corresponding to the size of the foam layer 3 is disposed on the foam layer 3, so that the sensor 4 can be in contact with the electrode of the measured instrument for measurement. Sensor 4 still connects outside computer 6 fixed establishment including solid fixed ring 2, fixation clamp 7, gu fixed ring 2 locates on the foam material layer 3 and spacing to the lower part of being surveyed the appearance electrode, fixation clamp 7 locates on the foam material layer 3 and is "7" type structure, fixation clamp 7 is spacing to the upper portion of being surveyed the appearance electrode. The surface of the sensor 4 is also provided with a temperature display screen 5.
In this embodiment, the fixing ring 2 is used for limiting the lower portion of the electrode 1 of the device under test, and the fixing clip 7 is used for limiting the upper portion of the electrode 1 of the device under test. So that the electrode 1 of the instrument to be measured can be stably fixed on the foam material layer 3. The sensor 4 is a temperature sensor.
Accurate measurement of temperature: the electrode of the percutaneous partial pressure monitor is provided with an intelligent temperature control system, has the functions of automatic heating and automatic heating stopping, heats the monitored epidermis through the electrode, so that oxygen in the epidermis, subcutaneous tissues and related capillary vessels is transferred to the electrode through diffusion and the like, and is transmitted to the electrode through TcPO2The monitor measures its oxygen partial pressure. The electrodes heat the skin of a human body for a long time, the temperature needs to be accurately and stably controlled, the accuracy of the instrument is affected when the temperature is too low, and destructive damage is caused to the skin of the human body when the temperature is too high. Accurate measurement of the electrode heating performance over a long period of time is therefore required.
In this embodiment, the temperature measuring mechanism is a dedicated temperature measuring device. The fixed ring 2 and the fixed clamp 7 of the mechanism fix the probe of the electrode 1 of the measured instrument, the measured equipment is connected with the temperature sensor 4, the temperature sensor 4 uses a high-precision platinum resistance sensor to measure the temperature of the electrode probe of the measured instrument, and the temperature data is collected and transmitted to the computer 6. And finally, the computer 6 corrects, calculates and stores the data by using a self-developed temperature calibration system.
As shown in fig. 2, the partial pressure monitoring mechanism comprises a standard gas cylinder 16, a gas heater 15, a pipeline 13 and a mixing gas chamber 12 which are connected in sequence. The side of the mixing air chamber 12 is provided with a fixed port 11, and the mixing air chamber 12 is connected with a pipeline 13 through the fixed port 11. The upper part of the mixing air chamber 12 is provided with a pressure gauge 17. 14 is a connector made of a rubber nail. 18 is an air pressure gauge of an empty box equipped outside.
Accuracy of partial pressure value: the percutaneous partial pressure monitor is mainly used for human body TcPO2And TcPCO2The data information obtained by detection becomes the clinical common examination index such as wound treatment evaluation, hyperbaric oxygen medicine, amputation height judgment and the like. Thus TcPO2And TcPCO2Becomes a crucial ring. The accuracy of the partial pressure value of the transcutaneous partial pressure monitor is evaluated by measuring the indicating value error and nonlinearity of various standard gas oxygen partial pressure/carbon dioxide partial pressure values.
In this embodiment, the partial pressure detecting portion uses a standard gas cylinder and a mixing gas chamber for testing, as shown in fig. 3-5, the partial pressure detecting portion includes a calibration electrode 100, the calibration electrode 100 in fig. 4 is connected to a fixing ring, and the calibration electrode 100 in fig. 5 is connected to the mixing gas chamber 12 for calibration.
In this embodiment, the electrodes of the device to be tested are installed in the mixing air chamber 12, different standard gases are heated in turn and introduced into the mixing air chamber 12, and the measurement data result of the device to be tested is recorded and analyzed. Different concentrations of standard gases are specifically tailored for use in the cylinder 16. The gas heater 15 adopts a medical heater to heat the gas in the pipeline, and can adjust the standard gas to reach the use temperature.
The standard gases are shown in the table below.
TABLE 1 Standard gas concentrations
As shown in the figures 1-6 of the drawings,
a method of calibrating a device using a transcutaneous partial pressure monitor, comprising the steps of:
s1, measuring a partial pressure monitoring mechanism, namely evaluating the accuracy of a partial pressure value of a percutaneous partial pressure monitor by measuring indication errors and nonlinearity of oxygen partial pressure/carbon dioxide partial pressure values of various standard gases;
s2, electrodes of the instrument to be measured are placed into a temperature measuring mechanism to be fixed, the temperature of the percutaneous partial pressure monitor is set, the percutaneous partial pressure monitor is enabled to work normally and be preheated, the temperature measuring mechanism starts to work after the temperature is stable, and the measured temperature is continuously recorded; and calculating the difference between the maximum temperature and the control temperature and the temperature fluctuation degree to finish the evaluation of the temperature performance of the percutaneous partial pressure monitor.
In step S1, the specific steps are:
A. the metabolic correction factor and severinghau temperature correction factor are set to "0" and "off" respectively in the setting; fixing the electrode of the percutaneous partial pressure monitor in the mixed gas chamber;
B. heating standard gas to 37 ℃ by a gas heater, introducing the standard gas into a mixed gas chamber, after 10min of stabilization time, respectively reading the numerical value of a percutaneous partial pressure monitor by using standard gas 1, standard gas 2 and standard gas 1, and simultaneously measuring the real-time pressure value in the mixed gas chamber by using a pressure gauge and an empty box barometer;
C. measuring real-time pressure values through a pressure gauge and an empty box barometer to calculate an oxygen partial pressure value in the mixed gas chamber, and comparing the oxygen partial pressure value with a value of a percutaneous partial pressure monitor to calculate a value indicating error;
in the formula: p
Press and press-the sum of the indication values of the empty-box barometer and the standard pressure meter;
-the pressure gauge is an arithmetic mean of 3 readings; p
Air conditioner-a barometric pressure indication value.
In the formula: Δ P-partial pressure indicating error;
-the transcutaneous partial pressure monitor shows a 3-fold arithmetic mean; p
Press and press-the sum of the pressure gauge and the pressure gauge indication; c-Standard gas concentration.
D. Respectively reading the numerical values of the monitor by using standard gases 1, 2 and 1, and calculating the nonlinearity of the percutaneous partial pressure monitor by judging whether the reading meets the requirements of the following table 2;
TABLE 2
E. And then, heating the standard gas to 43 ℃ by using a gas heater, introducing the standard gas into the mixing gas chamber, and measuring and calculating according to the step C, D after a period of stabilization time.
In step S2, the temperature of the percutaneous partial pressure monitor is set to 45 ℃, and the measured temperature is recorded for 30 min.
It should be understood that the above-described embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. Any modification, equivalent replacement, and improvement made within the spirit and principle of the present invention should be included in the protection scope of the claims of the present invention.