CN111398663B - Cardiac pacemaker induction current testing method and processing terminal - Google Patents
Cardiac pacemaker induction current testing method and processing terminal Download PDFInfo
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- CN111398663B CN111398663B CN202010503784.5A CN202010503784A CN111398663B CN 111398663 B CN111398663 B CN 111398663B CN 202010503784 A CN202010503784 A CN 202010503784A CN 111398663 B CN111398663 B CN 111398663B
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01R—MEASURING ELECTRIC VARIABLES; MEASURING MAGNETIC VARIABLES
- G01R19/00—Arrangements for measuring currents or voltages or for indicating presence or sign thereof
- G01R19/02—Measuring effective values, i.e. root-mean-square values
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01R—MEASURING ELECTRIC VARIABLES; MEASURING MAGNETIC VARIABLES
- G01R19/00—Arrangements for measuring currents or voltages or for indicating presence or sign thereof
- G01R19/003—Measuring mean values of current or voltage during a given time interval
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01R—MEASURING ELECTRIC VARIABLES; MEASURING MAGNETIC VARIABLES
- G01R19/00—Arrangements for measuring currents or voltages or for indicating presence or sign thereof
- G01R19/04—Measuring peak values or amplitude or envelope of ac or of pulses
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01R—MEASURING ELECTRIC VARIABLES; MEASURING MAGNETIC VARIABLES
- G01R19/00—Arrangements for measuring currents or voltages or for indicating presence or sign thereof
- G01R19/10—Measuring sum, difference or ratio
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01R—MEASURING ELECTRIC VARIABLES; MEASURING MAGNETIC VARIABLES
- G01R19/00—Arrangements for measuring currents or voltages or for indicating presence or sign thereof
- G01R19/165—Indicating that current or voltage is either above or below a predetermined value or within or outside a predetermined range of values
- G01R19/16566—Circuits and arrangements for comparing voltage or current with one or several thresholds and for indicating the result not covered by subgroups G01R19/16504, G01R19/16528, G01R19/16533
- G01R19/16571—Circuits and arrangements for comparing voltage or current with one or several thresholds and for indicating the result not covered by subgroups G01R19/16504, G01R19/16528, G01R19/16533 comparing AC or DC current with one threshold, e.g. load current, over-current, surge current or fault current
Abstract
The invention discloses a method for testing induction current of a cardiac pacemaker and a processing terminal, which relate to the field of medical instruments and comprise the following steps: setting a test condition corresponding to the induced current test item; controlling the test signal generator to send out corresponding test signals according to the test frequency points and the test voltage corresponding to each test frequency point, testing to obtain the induction voltage corresponding to the cardiac pacemaker under each test signal, and calculating to obtain the true effective value of the corresponding induction current; and judging the true effective value of each induction current with a judgment standard corresponding to the induction current test item respectively to obtain all test results of the cardiac pacemaker under the test conditions. The invention automatically tests whether the cardiac pacemaker is qualified under different test signals, automatically executes the transmission of the whole test signal and the judgment of the test result without human participation, and improves the test efficiency.
Description
Technical Field
The invention relates to the field of medical instrument inspection and certification, in particular to a method for testing induction current of a cardiac pacemaker and a processing terminal.
Background
The cardiac pacemaker is a device which is implanted in a patient body in an active implantable medical device and is used for treating arrhythmia, and belongs to three high-risk medical devices.
In order to ensure the life safety of patients, the cardiac pacemaker is required to have better immunity performance to non-ionizing electromagnetic radiation disturbance, so that the cardiac pacemaker needs to be tested for the non-ionizing electromagnetic radiation before the products are marketed to verify the electromagnetic compatibility of the cardiac pacemaker, and the international standards ISO 14117 and ISO 14708-2 have detailed test methods and requirements, and the latter is also converted into the national mandatory standard GB 16174.2.
The non-ionizing electromagnetic radiation test of the cardiac pacemaker performed according to the standards generally involves tests of a plurality of chambers (atria and ventricles), defibrillation interfaces and a plurality of corresponding test loops (differential mode and common mode).
Disclosure of Invention
The invention aims to provide an induced current testing method and a processing terminal of a cardiac pacemaker, which can automatically control the sending of a test signal and the reading and comparison of oscilloscope values, thereby realizing automatic testing and improving the testing efficiency.
The technical scheme provided by the invention is as follows:
a method for testing the induction current of a cardiac pacemaker is applied to a processing terminal, the processing terminal is electrically connected with a switching device for testing the induction current of the cardiac pacemaker, the cardiac pacemaker is electrically connected with the switching device, a test signal generator is electrically connected with the switching device, and an oscilloscope is electrically connected with the switching device, wherein the method for testing the induction current of the cardiac pacemaker comprises the following steps: acquiring a test condition corresponding to an induced current test item, wherein the test condition comprises: a plurality of test frequency points and test voltages corresponding to each test frequency point; controlling the test signal generator to send out corresponding test signals according to the test frequency points and the test voltage corresponding to each test frequency point, testing to obtain the induction voltage corresponding to the cardiac pacemaker under each test signal, and calculating to obtain the true effective value of the corresponding induction current; judging the true effective value of each induction current with a judgment standard corresponding to the induction current test item respectively to obtain all test results of the cardiac pacemaker under the test condition;
wherein the step of testing to obtain the induced voltage corresponding to the cardiac pacemaker under each test signal comprises:
selecting the time length of a reading signal section according to the frequency of the test signal;
reading the peak-to-peak data of the n sections of the read signal sections, arranging the peak-to-peak data in a descending order, removing m larger peak-to-peak data, and reserving n-m peak-to-peak data;
if the ratio of the maximum value A to the minimum value Z of the n-m reserved peak-to-peak value data is larger than or equal to a preset ratio, repeatedly reading the peak-to-peak value data of the n sections of the reading signal sections, removing n + m peak-to-peak value data from large to small, and reserving the n-m peak-to-peak value data;
if the ratio of the maximum value A to the minimum value Z of the n-m reserved peak-to-peak value data is larger than or equal to the preset ratio, repeatedly reading the peak-to-peak value data of the n sections of the reading signal section until the ratio of the maximum value A to the minimum value Z of the n-m reserved peak-to-peak value data is smaller than the preset ratio;
outputting the average value of the retained n-m peak-to-peak data as the induction voltage;
if the ratio of the maximum value A to the minimum value Z of the n-m peak-to-peak value data retained by multiple cycles is still larger than or equal to the preset ratio, the frequency test is terminated, the average value of the n-m peak-to-peak value data retained last is output, a test result column is blank, and the next frequency test is carried out.
In the technical scheme, the processing terminal controls the test signal generator to automatically send the test signal, automatically reads the numerical value of the oscilloscope, calculates and judges to obtain the test result, the whole test process is automated, and the test efficiency is improved.
Further, the controlling the test signal generator to send out corresponding test signals according to the test frequency points and the test voltage corresponding to each test frequency point, and the obtaining of the induction voltage corresponding to the cardiac pacemaker under each test signal through testing includes: and controlling the test signal generator to send out corresponding test signals according to each test frequency point and the test voltage corresponding to the test frequency point, and after the test for a preset time, testing to obtain the peak value of the induced voltage of the cardiac pacemaker under the test signals.
In the technical scheme, each test signal lasts for a preset time, so that the peak value of the induced voltage obtained by testing has higher reference value.
In the technical scheme, the peak value of the induction voltage is automatically extracted in the average mode of the oscilloscope, so that the precision of test data can be improved.
Further, the determining the true effective value of each induced current according to the determination criteria corresponding to the induced current test items includes: judging the true effective value and the first preset current value of the induced current corresponding to the test signal with the test frequency in the first preset range in the test frequency point; and judging the true effective value and the second preset current value of the induced current corresponding to the test signal with the test frequency in the second preset range in the test frequency point.
In the technical scheme, different signal frequencies have different judgment standards, and judgment is carried out according to different conditions, so that the reasonability and the accuracy of a test result are ensured.
Further, still include: and storing all test results in a preset database.
In the technical scheme, the test result is stored, so that subsequent calling and synchronization are facilitated.
The invention also provides a processing terminal, the processing terminal is electrically connected with a switching device for testing the induction current of the cardiac pacemaker, the cardiac pacemaker is electrically connected with the switching device, the test signal generator is electrically connected with the switching device, the oscilloscope is electrically connected with the switching device, and the processing terminal comprises: the obtaining module is used for obtaining a test condition corresponding to the induced current test item, and the test condition comprises: a plurality of test frequency points and test voltages corresponding to each test frequency point; the control module is used for controlling the test signal generator to send out corresponding test signals according to the test frequency points and the test voltage corresponding to each test frequency point, obtaining the induction voltage corresponding to the cardiac pacemaker under each test signal through testing, and calculating to obtain the true effective value of the corresponding induction current; the judging module is used for judging the true effective value of each induction current and a judging standard corresponding to the induction current test item respectively to obtain all test results of the cardiac pacemaker under the test condition;
wherein the step of testing by the control module the induced voltage corresponding to each test signal of the cardiac pacemaker comprises:
selecting the time length of a reading signal section according to the frequency of the test signal;
reading the peak-to-peak data of the n sections of the read signal sections, arranging the peak-to-peak data in a descending order, removing m larger peak-to-peak data, and reserving n-m peak-to-peak data;
if the ratio of the maximum value A to the minimum value Z of the n-m reserved peak-to-peak value data is larger than or equal to a preset ratio, repeatedly reading the peak-to-peak value data of the n sections of the reading signal sections, removing n + m peak-to-peak value data from large to small, and reserving the n-m peak-to-peak value data;
if the ratio of the maximum value A to the minimum value Z of the n-m reserved peak-to-peak value data is larger than or equal to the preset ratio, repeatedly reading the peak-to-peak value data of the n sections of the reading signal section until the ratio of the maximum value A to the minimum value Z of the n-m reserved peak-to-peak value data is smaller than the preset ratio;
outputting the average value of the retained n-m peak-to-peak data as the induction voltage;
if the ratio of the maximum value A to the minimum value Z of the n-m peak-to-peak value data retained by multiple cycles is still larger than or equal to the preset ratio, the frequency test is terminated, the average value of the n-m peak-to-peak value data retained last is output, a test result column is blank, and the next frequency test is carried out.
In the technical scheme, the processing terminal controls the test signal generator to automatically send the test signal, automatically reads the numerical value of the oscilloscope, calculates and judges to obtain the test result, the whole test process is automated, and the test efficiency is improved.
Further, the control module controls the test signal generator to send out corresponding test signals according to the test voltage corresponding to each test frequency point and each test frequency point, and the step of obtaining the induction voltage corresponding to the cardiac pacemaker under each test signal through testing comprises the following steps: and the test module is used for controlling the test signal generator to send out corresponding test signals according to each test frequency point and the corresponding test voltage, and after the test for a preset time, the peak value of the induced voltage of the cardiac pacemaker under the test signals is obtained through testing.
Further, the determining module determines the true effective value of each induced current according to the determination criteria corresponding to the induced current test items, respectively, including: the judging module is used for judging the true effective value and the first preset current value of the induced current corresponding to the test signal with the test frequency in the first preset range in the test frequency point; and judging the true effective value of the induced current corresponding to the test signal with the test frequency in the second preset range in the test frequency point and a second preset current value.
Further, still include: and the storage module is used for storing all the test results to a preset database.
Compared with the prior art, the method for testing the induction current of the cardiac pacemaker and the processing terminal have the advantages that:
the processing terminal controls the test signal generator to automatically send corresponding test signals according to set test conditions in the test process, the processing terminal automatically reads the induced voltage of the cardiac pacemaker on the oscilloscope under different test signals, the true effective value of the induced current is calculated and judged to obtain a test result, the whole test process can be automatically controlled by the processing terminal to be executed, manual participation is not needed, and the test efficiency is greatly improved.
Drawings
The above features, technical features, advantages and implementations of a pacemaker induction current testing method and processing terminal will be further described in the following detailed description of preferred embodiments in a clearly understandable manner with reference to the accompanying drawings.
FIG. 1 is a flow chart of one embodiment of a method for sensing electrical current in a cardiac pacemaker of the present invention;
FIG. 2 is a schematic structural diagram of an embodiment of a processing terminal of the present invention;
FIG. 3 is a schematic block diagram of one embodiment of a test system of the present invention;
fig. 4 is a flow chart of another embodiment of the method for sensing electrical current of the cardiac pacemaker of the present invention.
Detailed Description
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following description will be made with reference to the accompanying drawings. It is obvious that the drawings in the following description are only some examples of the invention, and that for a person skilled in the art, other drawings and embodiments can be derived from them without inventive effort.
For the sake of simplicity, the drawings only schematically show the parts relevant to the present invention, and they do not represent the actual structure as a product. In addition, in order to make the drawings concise and understandable, components having the same structure or function in some of the drawings are only schematically illustrated or only labeled. In this document, "one" means not only "only one" but also a case of "more than one".
The induction current item of the cardiac pacemaker is used for testing whether the cardiac pacemaker can increase the intensity of local induction current when the cardiac pacemaker is positioned in a patient body due to a peripheral electromagnetic field, so that the patient is injured, and the safety of the cardiac pacemaker can be ensured only after the test is passed.
Patent documents 201920480025.4, 201920480041.3, 201920480490.8 and 201920480488.0 disclose switching devices and systems for testing various test items of an implantable cardiac device, and the present invention adopts the systems disclosed in the above patent documents to automatically test items of induced current of a cardiac pacemaker.
As shown in fig. 3, the test system of the present invention includes: a switching device 300 for cardiac pacemaker induced current testing. The switching apparatus 300 includes: a connection control module 320 connected with the cardiac pacemaker (also called an implantable pulse generator) 200; and the equivalent tissue circuit 310 is connected with the connection control module 320 and is used for simulating human tissues.
The system of the present invention further comprises: a test signal generator 400 connected to the equivalent tissue circuit 310 for generating a test signal; a first oscilloscope 600 (which is optional, if the test signal from the test signal generator 400 does not need to be monitored, the first oscilloscope 600 may not be connected), connected to the equivalent tissue circuit 310, and configured to monitor the test signal from the test signal generator 400; a second oscilloscope 500 connected to the equivalent tissue circuit 310 for monitoring the pulse signal from the cardiac pacemaker 200; and the processing terminal 900 is configured to read data from the first oscilloscope 600 and the second oscilloscope 500, and detect a test result in a corresponding test mode.
Specifically, the cardiac pacemaker 200 is an implantable pulse generator that has the function of treating arrhythmia.
The test signal generator 400 is mainly used to send a test signal, and the second oscilloscope 500 is used to display the output condition of the cardiac pacemaker 200 under the test signal (i.e., the condition of the induced current thereof).
The processing terminal 900 may be an electronic device with control capability, such as a computer, on which a test program is run, an oscilloscope and a test signal generator which are connected in a control manner are controlled, and the cardiac pacemaker is tested.
Optionally, when the connection of the cardiac pacemaker, the switching device, the test signal generator, the oscilloscope and the processing terminal is completed and the test program is run formally, the processing terminal detects whether the connection of the oscilloscope and the test signal generator is correct or not, and if not, a prompt is sent in time to allow a tester to adjust the connection. The connection of the first oscilloscope, if any, is also checked.
Fig. 1 shows an embodiment of the method of the present invention, and the method for testing the induction current of the cardiac pacemaker is applied to a processing terminal 900, and comprises the following steps:
s101, acquiring a test condition corresponding to the induced current test item, and manually setting the test condition by a tester.
Specifically, the cardiac pacemaker device needs to test a plurality of modes based on its structural design, and therefore, the test conditions include: the testing method comprises the steps of testing polarity, a test product running mode, a testing port, a plurality of testing frequency points and testing voltage corresponding to each testing frequency point.
The test polarity includes: unipolar, bipolar differential mode, bipolar common mode, and defibrillation paths.
The test product operation mode (selected according to the model and the performance of the cardiac pacemaker to be tested) comprises the following steps: DDD, VVI, AAI, and SSI.
The test port includes: ventricular pacing/sensing, atrial pacing/sensing, right ventricular pacing/sensing, defibrillation/transpulmonary port and the like, and the selection is carried out according to the cardiac pacemaker to be tested.
The test frequency points are set according to the induced current test items, one test frequency point is a group of test signals with signal frequency, and the test signals with signal frequency in each group have corresponding test voltage (also called amplitude). The multiple groups of devices are used for testing the condition of the cardiac pacemaker under test signals with different signal frequencies, so that the cardiac pacemaker can normally work under the surrounding electromagnetic fields with different frequencies, and the life safety of a patient is not influenced.
The test signal includes: the sine wave signal and the modulation signal are determined according to the signal frequency. For example: the test signal corresponding to the signal frequency of 16.6-20 kHz is a sine wave signal with the amplitude of 1V; the test signal corresponding to the signal frequency of 500KHz is a modulation signal with the amplitude of 2V.
S102, controlling the test signal generator to send out corresponding test signals according to the test frequency points and the test voltage corresponding to each test frequency point, testing to obtain the induction voltage corresponding to the cardiac pacemaker under each test signal, and calculating to obtain the true effective value of the corresponding induction current.
Specifically, when the test is started, the test signal generator sends corresponding test signals one by one according to the multiple test frequency points and the test voltage corresponding to each test frequency point, so as to test the condition of the cardiac pacemaker under different test signals.
The true effective value of the induced current is obtained by dividing the peak-to-peak voltage value displayed on the second oscilloscope by a fixed resistance (i.e., 232 ohms). Optionally, the induced voltage peak value Uk of the tested cardiac pacemaker corresponding to each test signal can be displayed on a program interface, so that a tester can manually compare values displayed on an oscilloscope, and the accuracy of a test result obtained by a test program is ensured.
And sending prompt information before the test signal sent by the test signal generator is a modulation signal, so that a tester is connected with the filter to the equivalent tissue circuit.
Optionally, the step of testing in S102 to obtain the induced voltage corresponding to the cardiac pacemaker under each test signal includes:
and controlling the test signal generator to send out corresponding test signals according to each test frequency point and the test voltage corresponding to the test frequency point, and after the test for a preset time, testing to obtain the peak value of the induced voltage of the cardiac pacemaker under the test signals.
Alternatively, the induced voltage peak-to-peak value of the cardiac pacemaker under the test signal can be obtained by automatically reading the induced voltage peak-to-peak value on the second oscilloscope by the processing terminal.
Specifically, when the cardiac pacemaker is tested under test signals of different frequencies, the sending time of the test signal of each frequency lasts for a period of time, so that the cardiac pacemaker is conveniently under the test signal for a period of time, and the measured value of the average mode of the oscilloscope is read, so that the read peak value of the induced voltage has enough accuracy.
In this embodiment, the test signal of each signal frequency is preset according to the strength of the signal, the dwell time of the test signal with a stronger signal frequency is shorter than that of the test signal with a weaker signal frequency, and the dwell time of the test signal with a weaker signal frequency is longer than that of the test signal with a weaker signal frequency. For example, the test signal with lower frequency of 16.6Hz-1kHz stays for 15 s; the test signal with a frequency greater than 1kHz dwells for 5 s. In other embodiments, the preset time for each signal frequency may be different.
Optionally, the step of testing the peak value of the induced voltage of the cardiac pacemaker under the test signal comprises: and reading the measurement value of the average mode of the oscilloscope, and extracting the peak value of the induction voltage.
Optionally, the step of testing the induced voltage corresponding to the cardiac pacemaker under each test signal comprises:
selecting the time length of the signal reading section according to the frequency of the test signal; reading the peak-to-peak data of the n read signal sections, arranging the peak-to-peak data in a descending order, removing m larger peak-to-peak data, and reserving n-m peak-to-peak data; if the ratio of the maximum value A to the minimum value Z of the n-m reserved peak-to-peak value data is larger than or equal to the preset ratio, repeatedly reading the peak-to-peak value data of the n sections of reading signal sections, removing n + m peak-to-peak value data from large to small, and reserving the n-m peak-to-peak value data; if the ratio of the maximum value A to the minimum value Z of the n-m reserved peak-to-peak value data is larger than or equal to the preset ratio, repeatedly reading the peak-to-peak value data of the n sections of reading signal sections until the ratio of the maximum value A to the minimum value Z of the n-m reserved peak-to-peak value data is smaller than the preset ratio; outputting the average value of the retained n-m peak-to-peak data as the induction voltage; if the ratio of the maximum value A to the minimum value Z of the n-m peak-to-peak value data retained by multiple cycles is still larger than or equal to the preset ratio, the frequency test is terminated, the average value of the n-m peak-to-peak value data retained last is output, a test result column is blank, and the next frequency test is carried out.
Specifically, in this embodiment, the oscilloscope sets the recording length to 1000, the oscilloscope sets the mode to resolution mode, auto-scrolling screen and no trigger, the abscissa scale of one screen of the oscilloscope retains 5 waves of about cycle, 2s is stopped after the test signal switches the frequency, 10 peak-to-peak values are read again, one is read for 1 second, and the data is processed by frequency division: removing 7 values from large to small, and remaining 3 peak-to-peak values, wherein c (f) is a function of frequency and can be respectively set according to the frequency; if the ratio A/Z of the maximum value A to the minimum value Z is more than or equal to c (f), repeating the previous process to read 10 peak-to-peak values, removing 17 values from large to small in the 20 read values, and if the ratio A/Z of the maximum value A to the minimum value Z is more than or equal to c (f) for the rest 3 values, repeating the above process again, removing 27 values from large to small in the 30 read values, if the ratio A/Z of the maximum value A to the minimum value Z is more than or equal to c (f), terminating the frequency test, outputting the average value of the minimum three values, and switching to the next frequency test if the test result column is blank; and if the ratio A/Z of the maximum value A to the minimum value Z is less than c (f), outputting the average value of the three values as the frequency test result. The induction voltage corresponding to each test signal of the cardiac pacemaker is obtained by the method, the influence of the oscilloscope can be avoided, and a more accurate true effective value of the induction current can be obtained.
S103, the true effective values of the induction currents are respectively judged according to the judgment standards corresponding to the induction current test items, and all test results of the cardiac pacemaker under the test conditions are obtained.
Specifically, the effective value of the induced current of the cardiac pacemaker under each test signal is qualified, and whether the cardiac pacemaker is qualified under the test signal is judged, so that one test result exists under one test signal.
Optionally, the determining, in S103, the true effective value of each induced current according to the determination criterion corresponding to the induced current test item includes:
judging the true effective value and the first preset current value of the induced current corresponding to the test signal with the test frequency in the first preset range in the test frequency point;
and judging the true effective value and the second preset current value of the induced current corresponding to the test signal with the test frequency in the second preset range in the test frequency point.
Specifically, the judgment standards corresponding to different test signals are different, and the judgment is performed according to actual conditions. The first preset range is 16.6Hz-1KHz, 500kHz, and the corresponding first preset current value is 50 uA. And when the true effective value of the induction current obtained by calculation is less than 50uA, the test standard is met.
The second predetermined range is 1kHz-20kHz, and the corresponding second predetermined current value is (50 uA signal frequency)/1 kHz. The true effective value of the induced current calculated is less than the value, and the measured value meets the test standard.
For example: and 2 test frequency points, wherein the signal frequency of the test frequency point 1 is 500 Hz, the amplitude is 1V, after the test signal generator sends out a corresponding test signal, the oscilloscope is read, the true effective value 1 of the induced current is obtained through calculation, whether the true effective value 1 of the induced current is smaller than 50uA or not is judged, if so, the test result is in line, and if not, the test result is not in line. The signal frequency of the test frequency point 2 is 15 kHz, the amplitude is 1V, after the test signal generator sends out a corresponding test signal, the oscilloscope is read, the true effective value 2 of the induced current is obtained through calculation, whether the true effective value 2 of the induced current is smaller than (50 uA 15 kHz)/1 kHz =750 uA or not is judged, if so, the test result is in line, and if not, the test result is not in line.
Through the method, all test results of the cardiac pacemaker under different test signals are obtained through testing. Optionally, all the test results are stored in a preset database under a directory corresponding to the sample number of the cardiac pacemaker.
Specifically, after all the test signals are sent and the true effective values of the induction currents are judged, the test results can be directly imported into corresponding files (such as txt files) and stored in a preset database, so that subsequent calling and synchronization are facilitated. The sample number of each cardiac pacemaker corresponds to one folder, so that the test result of each cardiac pacemaker can be uniformly stored, if one test system of a certain cardiac pacemaker is half tested, the test system is moved to another test system for testing, and after data synchronization, the test can be carried out without carrying out the test again, and the tested frequency points which are not tested can be directly tested.
The preset database has various forms, for example: and the cloud database, the Access database and the like are set according to actual conditions.
Optionally, during the testing process, the processing terminal displays the sample number of the currently tested cardiac pacemaker, the input testing conditions, and the corresponding testing results under each testing signal. And the test frequency point (also can be understood as signal frequency) of the test signal sent by the current test signal generator, the connection relation between the switching equipment, the processing terminal, the oscilloscope and the cardiac pacemaker and the like can also be displayed.
Optionally, a control button of the test signal generator is displayed on the processing terminal. That is, the test signal generator may be controlled by the control buttons during the test.
For example: in the testing process, when a pause instruction is received, the testing signal corresponding to the current testing frequency point is continuously sent, but the timing of the preset time is stopped; when a starting instruction is received, timing the preset time of the test signal corresponding to the current test frequency point; and when a cancel instruction is received, popping up a prompt box, inquiring whether the test is finished or not, and if so, finishing the test.
In the embodiment, the processing terminal controls the test signal generator to automatically send corresponding test signals according to set test conditions in the test process, the processing terminal automatically reads the induced voltage of the cardiac pacemaker on the oscilloscope under different test signals, the true effective value of the induced current is calculated and judged to obtain a test result, the whole test process can be automatically controlled by each device to be executed by the processing terminal, human participation is not needed, and the test efficiency is greatly improved.
Fig. 2 shows an embodiment of a processing terminal of the present invention, where the processing terminal 900 is electrically connected to a switching device for cardiac pacemaker induced current testing, the cardiac pacemaker is electrically connected to the switching device, the test signal generator is electrically connected to the switching device, and the oscilloscope is electrically connected to the switching device.
The processing terminal 900 includes:
the obtaining module 910 is configured to obtain a test condition corresponding to the induced current test item, where the test condition may be manually set by a tester.
Specifically, the cardiac pacemaker device needs to test a plurality of modes based on its structural design, and therefore, the test conditions include: the testing method comprises the steps of testing polarity, a test product running mode, a testing port, a plurality of testing frequency points and testing voltage corresponding to each testing frequency point.
The test polarity includes: unipolar, bipolar differential mode, bipolar common mode, and defibrillation paths.
The test product operation mode (selected according to the model and the performance of the cardiac pacemaker to be tested) comprises the following steps: DDD, VVI, AAI, and SSI.
The test port includes: ventricular pacing/sensing, atrial pacing/sensing, right ventricular pacing/sensing, defibrillation/transpulmonary port and the like, and the selection is carried out according to the cardiac pacemaker to be tested.
The test frequency points are set according to the induced current test items, one test frequency point is a group of test signals with signal frequency, and the test signals with signal frequency in each group have corresponding test voltage (also called amplitude). The multiple groups of devices are used for testing the condition of the cardiac pacemaker under test signals with different signal frequencies, so that the cardiac pacemaker can normally work under the surrounding electromagnetic fields with different frequencies, and the life safety of a patient is not influenced.
The test signal includes: the sine wave signal and the modulation signal are determined according to the signal frequency. For example: the test signal corresponding to the signal frequency of 16.6-20 kHz is a sine wave signal with the amplitude of 1V; the test signal corresponding to the signal frequency of 500KHz is a modulation signal with the amplitude of 2V.
And the control module 920 is configured to control the test signal generator to send out corresponding test signals according to each test frequency point and the test voltage corresponding to each test frequency point, obtain the induced voltage corresponding to each test signal of the cardiac pacemaker through testing, and calculate to obtain the true effective value of the corresponding induced current.
Specifically, when the test is started, the test signal generator sends corresponding test signals one by one according to the multiple test frequency points and the test voltage corresponding to each test frequency point, so as to test the condition of the cardiac pacemaker under different test signals.
The true effective value of the induced current is obtained by dividing the peak-to-peak voltage value displayed on the second oscilloscope by a fixed resistance (i.e., 232 ohms). Optionally, the induced voltage peak value Uk of the tested cardiac pacemaker corresponding to each test signal may be displayed by a display module (not shown in the figure) of the processing terminal, so that a tester can manually compare values displayed on the oscilloscope, and the accuracy of the test result obtained by the test program is ensured.
Optionally, the controlling module 920 controls the test signal generator to send out corresponding test signals according to each test frequency point and the test voltage corresponding to each test frequency point, and the obtaining of the induced voltage corresponding to the cardiac pacemaker under each test signal through the test includes:
and the test module is used for controlling the test signal generator to send out corresponding test signals according to each test frequency point and the corresponding test voltage, and after the test for a preset time, the peak value of the induced voltage of the cardiac pacemaker under the test signals is obtained through testing.
Alternatively, the induced voltage peak-to-peak value of the cardiac pacemaker under the test signal can be obtained by automatically reading the induced voltage peak-to-peak value on the second oscilloscope by the processing terminal.
Specifically, when the cardiac pacemaker is tested under test signals of different frequencies, the sending time of the test signal of each frequency lasts for a period of time, so that the cardiac pacemaker is conveniently under the test signal for a period of time, and the measured value of the average mode of the oscilloscope is read, so that the read peak value of the induced voltage has enough accuracy.
In this embodiment, the test signal of each signal frequency is preset according to the strength of the signal, the dwell time of the test signal with a stronger signal frequency is shorter than that of the test signal with a weaker signal frequency, and the dwell time of the test signal with a weaker signal frequency is longer than that of the test signal with a weaker signal frequency. For example, the test signal with lower frequency of 16.6Hz-1kHz stays for 15 s; the test signal with a frequency greater than 1kHz dwells for 5 s. In other embodiments, the preset time for each signal frequency may be different.
Optionally, the control module 920, the step of testing the peak value of the induced voltage of the cardiac pacemaker under the test signal includes: and the control module 920 reads the measurement value of the average mode of the oscilloscope and extracts the peak-to-peak value of the induced voltage.
The determining module 930 is configured to determine the true effective value of each of the induced currents according to the determining criteria corresponding to the induced current test items, so as to obtain all test results of the cardiac pacemaker under the test condition.
Specifically, the effective value of the induced current of the cardiac pacemaker under each test signal is qualified, and whether the cardiac pacemaker is qualified under the test signal is judged, so that one test result exists under one test signal.
Optionally, the determining module 930, determining the true effective value of each induced current according to the determination criterion corresponding to the induced current test item includes:
the determining module 930 is configured to determine a true effective value and a first preset current value of an induced current corresponding to a test signal with a test frequency within a first preset range in a test frequency point; and judging the true effective value of the induced current corresponding to the test signal with the test frequency in the second preset range in the test frequency point and a second preset current value.
Specifically, the judgment standards corresponding to different test signals are different, and the judgment is performed according to actual conditions. The first preset range is 16.6Hz-1KHz, 500kHz, and the corresponding first preset current value is 50 uA. And when the true effective value of the induction current obtained by calculation is less than 50uA, the test standard is met.
The second predetermined range is 1kHz-20kHz, and the corresponding second predetermined current value is (50 uA signal frequency)/1 kHz. The true effective value of the induced current calculated is less than the value, and the measured value meets the test standard.
Through the method, all test results of the cardiac pacemaker under different test signals are obtained through testing. Optionally, the processing terminal further includes: and the storage module (not shown in the figure) stores all the test results into a catalog corresponding to the sample numbers of the cardiac pacemakers in a preset database.
Specifically, after all the test signals are sent and the true effective values of the induction currents are judged, the test results can be directly imported into corresponding files (such as txt files) and stored in a preset database, so that subsequent calling and synchronization are facilitated. The sample number of each cardiac pacemaker corresponds to one folder, so that the test result of each cardiac pacemaker can be uniformly stored, if one test system of a certain cardiac pacemaker is half tested, the test system is moved to another test system for testing, and after data synchronization, the test can be carried out without carrying out the test again, and the tested frequency points which are not tested can be directly tested.
The preset database has various forms, for example: and the cloud database, the Access database and the like are set according to actual conditions.
Optionally, during the testing process, the display module of the processing terminal may display the sample number of the currently tested cardiac pacemaker, the input testing condition, and the corresponding testing result under each testing signal. And the test frequency point (also can be understood as signal frequency) of the test signal sent by the current test signal generator, the connection relation between the switching equipment, the processing terminal, the oscilloscope and the cardiac pacemaker and the like can also be displayed.
Optionally, the display module of the processing terminal may display the control buttons of the test signal generator. That is, the test signal generator may be controlled by the control buttons during the test.
For example: the control module is further used for continuously sending the test signal corresponding to the current test frequency point when a pause instruction is received in the test process, but stopping timing of the preset time; when a starting instruction is received, timing of the preset time of the test signal corresponding to the current test frequency point is continued; and when a cancel instruction is received, popping up a prompt box, inquiring whether the test is finished or not, and if so, finishing the test.
In the embodiment, the processing terminal controls the test signal generator to automatically send corresponding test signals according to set test conditions in the test process, the processing terminal automatically reads the induced voltage of the cardiac pacemaker on the oscilloscope under different test signals, the true effective value of the induced current is calculated and judged to obtain a test result, the whole test process can be automatically controlled by each device to be executed by the processing terminal, human participation is not needed, and the test efficiency is greatly improved.
Fig. 4 shows a flow chart of a method for sensing electrical current in a cardiac pacemaker comprising:
1. entering an induced current test item interface;
2. judging whether the signal source and the oscilloscope are correctly connected, if so, executing step 4, if not, executing step 3, popping up a connection error prompt, and executing step 4 when the signal source and the oscilloscope are reconnected by a tester and the connection is correct;
4. obtaining a test condition;
5. judging whether the signal frequency of the next group of test signals is 500KHz, if not, executing step 7, if so, executing step 6, and connecting the filter (in the embodiment, the test signals of 500KHz are modulation signals, because the filter is required to be connected, other test signals are sine wave signals, the filter is not required to be connected);
7. emptying the oscilloscope and starting to send a test signal;
8. after timing for 4 seconds, acquiring a peak value;
9. when the signal frequency is 16.6Hz-1kHz and 500kHz, judging whether the true effective value of the induction current is less than 50uA, if so, executing 11, and displaying the test result: conforming; if not, executing 12, and displaying the test result: (ii) not conform;
10. when the signal frequency is 1kHz-20kHz, judging whether the true effective value of the induced current is less than (50 uA signal frequency)/1 kHz, if so, executing 11, and displaying the test result: conforming; if not, executing 12, and displaying the test result: (ii) not conform;
13. judging whether the current test frequency point is the last group, if so, executing 14, stopping sending the test signal by the test signal generator, storing the test records (namely all test results) into an Access database, and 15, finishing the test; if not, the step 5 is repeated to carry out the measurement of the next group.
It should be noted that the above embodiments can be freely combined as necessary. The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.
Claims (7)
1. A method for testing the induction current of a cardiac pacemaker is characterized in that the method is applied to a processing terminal, the processing terminal is electrically connected with a switching device for testing the induction current of the cardiac pacemaker, the cardiac pacemaker is electrically connected with the switching device, a test signal generator is electrically connected with the switching device, an oscilloscope is electrically connected with the switching device, and the method for testing the induction current of the cardiac pacemaker comprises the following steps:
setting test conditions corresponding to the induced current test items, wherein the test conditions comprise: a plurality of test frequency points and test voltages corresponding to each test frequency point;
controlling the test signal generator to send out corresponding test signals according to the test frequency points and the test voltage corresponding to each test frequency point, testing to obtain the induction voltage corresponding to the cardiac pacemaker under each test signal, and calculating to obtain the true effective value of the corresponding induction current;
judging the true effective value of each induction current with a judgment standard corresponding to the induction current test item respectively to obtain all test results of the cardiac pacemaker under the test condition;
wherein the step of testing to obtain the induced voltage corresponding to the cardiac pacemaker under each test signal comprises:
selecting the time length of a reading signal section according to the frequency of the test signal;
reading the peak-to-peak data of the n sections of the read signal sections, arranging the peak-to-peak data in a descending order, removing m larger peak-to-peak data, and reserving n-m peak-to-peak data;
if the ratio of the maximum value A to the minimum value Z of the n-m reserved peak-to-peak value data is larger than or equal to a preset ratio, repeatedly reading the peak-to-peak value data of the n sections of the reading signal sections, removing n + m peak-to-peak value data from large to small, and reserving the n-m peak-to-peak value data;
if the ratio of the maximum value A to the minimum value Z of the n-m reserved peak-to-peak value data is larger than or equal to the preset ratio, repeatedly reading the peak-to-peak value data of the n sections of the reading signal section until the ratio of the maximum value A to the minimum value Z of the n-m reserved peak-to-peak value data is smaller than the preset ratio;
outputting the average value of the retained n-m peak-to-peak data as the induction voltage;
if the ratio of the maximum value A to the minimum value Z of the n-m peak-to-peak value data retained by multiple cycles is still larger than or equal to the preset ratio, the frequency test is terminated, the average value of the n-m peak-to-peak value data retained last is output, a test result column is blank, and the next frequency test is carried out.
2. The method for testing the induced current of the cardiac pacemaker as recited in claim 1, wherein the controlling the test signal generator to send out the corresponding test signal according to the test frequency points and the test voltage corresponding to each test frequency point, and the step of obtaining the induced voltage corresponding to the cardiac pacemaker under each test signal comprises:
and controlling the test signal generator to send out corresponding test signals according to each test frequency point and the test voltage corresponding to the test frequency point, and after the test for a preset time, testing to obtain the peak value of the induced voltage of the cardiac pacemaker under the test signals.
3. The method for testing an induced current of a cardiac pacemaker as recited in claim 1, wherein the determining the true effective value of each of the induced currents according to the determination criteria corresponding to the test item of the induced current comprises:
judging the true effective value and the first preset current value of the induced current corresponding to the test signal with the test frequency in the first preset range in the test frequency point;
and judging the true effective value and the second preset current value of the induced current corresponding to the test signal with the test frequency in the second preset range in the test frequency point.
4. A processing terminal is characterized in that the processing terminal is electrically connected with a switching device for testing the induction current of a cardiac pacemaker, the cardiac pacemaker is electrically connected with the switching device, a test signal generator is electrically connected with the switching device, and an oscilloscope is electrically connected with the switching device, and the processing terminal comprises:
the obtaining module is used for obtaining a test condition corresponding to the induced current test item, and the test condition comprises: a plurality of test frequency points and test voltages corresponding to each test frequency point;
the control module is used for controlling the test signal generator to send out corresponding test signals according to the test frequency points and the test voltage corresponding to each test frequency point, obtaining the induction voltage corresponding to the cardiac pacemaker under each test signal through testing, and calculating to obtain the true effective value of the corresponding induction current;
the judging module is used for judging the true effective value of each induction current and a judging standard corresponding to the induction current test item respectively to obtain all test results of the cardiac pacemaker under the test condition;
wherein the step of testing by the control module the induced voltage corresponding to each test signal of the cardiac pacemaker comprises:
selecting the time length of a reading signal section according to the frequency of the test signal;
reading the peak-to-peak data of the n sections of the read signal sections, arranging the peak-to-peak data in a descending order, removing m larger peak-to-peak data, and reserving n-m peak-to-peak data;
if the ratio of the maximum value A to the minimum value Z of the n-m reserved peak-to-peak value data is larger than or equal to a preset ratio, repeatedly reading the peak-to-peak value data of the n sections of the reading signal sections, removing n + m peak-to-peak value data from large to small, and reserving the n-m peak-to-peak value data;
if the ratio of the maximum value A to the minimum value Z of the n-m reserved peak-to-peak value data is larger than or equal to the preset ratio, repeatedly reading the peak-to-peak value data of the n sections of the reading signal section until the ratio of the maximum value A to the minimum value Z of the n-m reserved peak-to-peak value data is smaller than the preset ratio;
outputting the average value of the retained n-m peak-to-peak data as the induction voltage;
if the ratio of the maximum value A to the minimum value Z of the n-m peak-to-peak value data retained by multiple cycles is still larger than or equal to the preset ratio, the frequency test is terminated, the average value of the n-m peak-to-peak value data retained last is output, a test result column is blank, and the next frequency test is carried out.
5. The processing terminal of claim 4, wherein the control module controls the test signal generator to send out corresponding test signals according to the test voltages corresponding to the test frequency points and each test frequency point, and the obtaining of the induced voltage corresponding to the cardiac pacemaker under each test signal through testing comprises:
and the test module is used for controlling the test signal generator to send out corresponding test signals according to each test frequency point and the corresponding test voltage, and after the test for a preset time, the peak value of the induced voltage of the cardiac pacemaker under the test signals is obtained through testing.
6. The processing terminal of claim 4, wherein the determining module determines the true effective value of each of the induced currents according to a determination criterion corresponding to the induced current test item, respectively, comprises:
the judging module is used for judging the true effective value and the first preset current value of the induced current corresponding to the test signal with the test frequency in the first preset range in the test frequency point; and judging the true effective value of the induced current corresponding to the test signal with the test frequency in the second preset range in the test frequency point and a second preset current value.
7. The processing terminal of claim 4, further comprising:
and the storage module is used for storing all the test results to a preset database.
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