CN112043963A - Test method and processing terminal for anti-electromagnetic continuous failure of cardiac pacemaker - Google Patents
Test method and processing terminal for anti-electromagnetic continuous failure of cardiac pacemaker Download PDFInfo
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Abstract
The invention discloses a method for testing the anti-electromagnetic continuous failure of a cardiac pacemaker and a processing terminal, relating to the field of medical instruments, wherein the method comprises the following steps: setting a test condition corresponding to the anti-electromagnetic continuous failure test item; s2 obtaining a basic period and amplitude before the cardiac pacemaker test; s3, controlling the test signal generator to send corresponding test signals according to the signal source parameters in the test conditions, and obtaining the basic period and amplitude of the cardiac pacemaker after the test of each test signal; s4, respectively judging a period difference value between the tested basic period and an amplitude difference value between the tested amplitude and the tested amplitude according to a judgment standard corresponding to the anti-electromagnetic continuous failure test item, and obtaining a test result of the cardiac pacemaker under the test condition. The invention automatically completes the test and improves the test efficiency.
Description
Technical Field
The invention relates to the field of medical instrument inspection and certification, in particular to an anti-electromagnetic continuous failure testing method and a processing terminal for a cardiac pacemaker.
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 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), and in the existing electromagnetic resistance continuous failure test process (namely 27.3 in ISO 14708-2), a test signal generator needs to be manually adjusted, the value of an oscilloscope connected in the test also needs to be manually read, the test result of the active implantable cardiac medical device in each test is manually judged, the test efficiency is low, and the actual test requirement cannot be met.
Disclosure of Invention
The invention aims to provide an anti-electromagnetic continuous failure testing method and a processing terminal for a cardiac pacemaker, which 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 anti-electromagnetic continuous failure of a cardiac pacemaker is applied to a processing terminal, the processing terminal is electrically connected with a switching device for testing the induced 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, and the method comprises the following steps: s1, setting test conditions corresponding to the electromagnetic resistance continuous failure test items; s2 obtaining a basic period and amplitude before the cardiac pacemaker test; s3, controlling the test signal generator to send corresponding test signals according to the signal source parameters in the test conditions, and obtaining the basic period and amplitude of the cardiac pacemaker after the test of each test signal; s4, respectively judging a period difference value between the tested basic period and an amplitude difference value between the tested amplitude and the tested amplitude according to a judgment standard corresponding to the anti-electromagnetic continuous failure test item, and obtaining a test result of the cardiac pacemaker under the test condition.
In the technical scheme, after the processing terminal obtains the test conditions, the test signal generator, the oscilloscope and the switching device are automatically controlled to complete the test of the cardiac pacemaker, artificial participation is not needed, and the test efficiency is improved.
Further, the step S2 includes: and after waiting for a preset time, testing to obtain the basic period and amplitude before testing of the cardiac pacemaker.
In the above technical solution, the obtaining of the basic period and amplitude before the test after waiting for a period of time is to enable the obtained basic period and amplitude to accurately reflect the working condition of the cardiac pacemaker.
Further, the step S3 includes: controlling the test signal generator to send corresponding test signals according to the signal source parameters in the test conditions; waiting for a preset time after all the test signals corresponding to the signal source parameters are sent; and testing to obtain the basic period and amplitude of the cardiac pacemaker after each test signal is tested.
In the technical scheme, the waiting time is the same as the basic period and amplitude before the test is obtained, so that the obtained basic period and amplitude after the test have comparability, and the accuracy of the test result is ensured.
Further, the signal source parameters include: a plurality of groups of frequency information and signal output modes; the step S3 of controlling the test signal generator to send the corresponding test signal according to the signal source parameter in the test condition includes: and controlling the test signal generator to send test signals corresponding to a plurality of groups of frequency information according to the signal output mode.
In the technical scheme, different signal output modes provide different test signals for the cardiac pacemaker, and tests of different electromagnetic field conditions can be carried out.
Further, the step S4 includes: judging whether the period difference value is within a preset period error range or not; judging whether the amplitude difference value is within a preset amplitude error range or not; and when the period difference value is within a preset period error range and the amplitude difference value is within a preset amplitude error range, the test result is passed, otherwise, the test result is not passed.
In the technical scheme, the judgment standard is disclosed, and a judgment basis is provided for the test result.
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, the processing terminal comprises: the acquisition module is used for acquiring test conditions corresponding to the electromagnetic resistance continuous failure test item; the test module is used for acquiring a basic period and amplitude before the test of the cardiac pacemaker; the control module is used for controlling the test signal generator to send corresponding test signals according to the signal source parameters in the test conditions; the test module is further used for testing to obtain the basic period and amplitude of the cardiac pacemaker after the test of each test signal; and the judging module is used for respectively judging a period difference value between the tested basic period and an amplitude difference value between the tested amplitude and the tested amplitude according to a judging standard corresponding to the anti-electromagnetic continuous failure testing item, so as to obtain a testing result of the cardiac pacemaker under the testing condition.
According to the technical scheme, the processing terminal automatically completes the test of the cardiac pacemaker after acquiring the test conditions, human participation is not needed, and the test efficiency is improved.
Further, the obtaining, by the testing module, the base period and amplitude before the cardiac pacemaker test includes: and the test module is used for obtaining the basic period and amplitude before the test of the cardiac pacemaker after waiting for the preset time.
Further, the testing module, further configured to test and obtain a fundamental period and an amplitude of the cardiac pacemaker after the testing of each of the test signals, includes: the test module waits for a preset time after all test signals corresponding to the signal source parameters are sent; and testing to obtain the basic period and amplitude of the cardiac pacemaker after each test signal is tested.
Further, the signal source parameters include: a plurality of groups of frequency information and signal output modes; the control module is configured to control the test signal generator to send the corresponding test signal according to the signal source parameter in the test condition, and the control module includes: and the control module controls the test signal generator to send test signals corresponding to a plurality of groups of frequency information according to the signal output mode.
Further, the determining module is configured to respectively determine, according to a determination standard corresponding to the anti-electromagnetic sustained failure test item, a period difference between the tested basic period and the pre-test basic period, and an amplitude difference between the tested amplitude and the pre-test amplitude, and obtain the test result of the cardiac pacemaker under the test condition includes: the judging module is used for judging whether the period difference value is within a preset period error range; judging whether the amplitude difference value is within a preset amplitude error range or not; and when the period difference value is within a preset period error range and the amplitude difference value is within a preset amplitude error range, the test result is passed, otherwise, the test result is not passed.
Compared with the prior art, the electromagnetic-resistance continuous failure test method and the processing terminal for the cardiac pacemaker have the beneficial effects that:
the invention controls the switching device, the oscilloscope and the test signal generator through the processing terminal, automatically tests whether the cardiac pacemaker can still normally work (i.e. whether the cardiac pacemaker fails) after the cardiac pacemaker passes through a continuously fluctuating electromagnetic field, automatically executes the transmission of the whole test signal and the judgment of the test result without human participation, and improves the test efficiency.
Drawings
The above features, technical features, advantages and implementations of a method for testing a cardiac pacemaker against persistent electromagnetic failure and a processing terminal will be further described in detail in the following preferred embodiments with reference to the accompanying drawings.
FIG. 1 is a flow chart of one embodiment of a method for testing a cardiac pacemaker for resistance to persistent electromagnetic failure in accordance with the present invention;
FIG. 2 is a flow chart of another embodiment of a method for testing a cardiac pacemaker for resisting persistent electromagnetic failure in accordance with 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 schematic structural diagram of one embodiment of the processing terminal in fig. 3.
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 cardiac pacemaker needs to be tested before leaving the factory when the electromagnetic field around the cardiac pacemaker fluctuates continuously, the cardiac pacemaker cannot generate faults after the electromagnetic field is removed, and the safety of the cardiac pacemaker can be ensured only if the cardiac pacemaker does not generate faults, namely 27.3 in ISO 14708-2.
The patent documents with the application numbers of 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 invention adopts the test systems disclosed in the patent documents to automatically test the items of the implantable cardiac device for resisting the electromagnetic continuous failure.
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.
In particular, pacemaker 200 is an implantable pulse generator capable of delivering pulses for treating bradycardia.
The processing terminal 900 may be an electronic device with control and calculation capabilities, such as a computer, on which a test program is run, an oscilloscope and a test signal generator are controlled to be accessed, 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 present invention, and a method for testing a cardiac pacemaker against persistent electromagnetic failure is applied to a processing terminal 900, and the method includes the following steps:
s101, setting test conditions corresponding to the anti-electromagnetic continuous failure test items, wherein the test conditions can be manually set by a tester.
Specifically, the cardiac pacemaker device is suitable for testing in multiple modes based on the structural design thereof, and therefore, the test conditions include: testing polarity, a test product running mode, a testing port and signal source parameters.
The test polarity includes: unipolar, bipolar differential mode, and bipolar common mode.
The test product operation modes (selected according to the model and performance of the cardiac pacemaker to be tested) include but are not limited to: 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 signal source parameters are set according to the anti-electromagnetic continuous failure test item, the signal source parameters comprise a plurality of groups of frequency information and signal output modes, and each group of frequency information comprises: signal amplitude, signal frequency, and dwell time. Wherein, the dwell time has different requirements according to the signal output mode. The setting of the multiple groups of frequency information is to test that the cardiac pacemaker does not generate faults after experiencing continuously fluctuating electromagnetic fields; meanwhile, the arrangement of the multiple groups of frequency information enables the cardiac pacemaker to experience various electromagnetic fields, and the referential property of the test result is ensured.
After the processing terminal acquires the test conditions, the connection control module and the cardiac pacemaker are automatically controlled to carry out corresponding connection switching, and relevant manual wiring is not required to be carried out manually according to the test conditions, so that the test efficiency is improved.
S102 acquires a base period and amplitude before a cardiac pacemaker test.
Specifically, before the cardiac pacemaker is not exposed to a continuously fluctuating electromagnetic field, the normal basic cycle and amplitude of the cardiac pacemaker are tested for subsequent comparison to determine whether the cardiac pacemaker is working normally.
S103, controlling a test signal generator to send corresponding test signals according to the signal source parameters in the test conditions, and obtaining the basic period and amplitude of the cardiac pacemaker after the test of each test signal.
Specifically, the test signal corresponding to the signal source parameter is a sinusoidal signal. After the cardiac pacemaker is subjected to a plurality of sinusoidal test signals, the basic period and amplitude after the test are obtained and are respectively compared with the basic period and amplitude before the test, so that whether the cardiac pacemaker still normally works after the electromagnetic field is removed after the cardiac pacemaker is subjected to the continuously fluctuating electromagnetic field is judged.
Optionally, the process of testing the obtained fundamental period and amplitude comprises: and reading the measurement value of the average mode of the oscilloscope, and extracting the basic period and the amplitude. The data read in the average mode is more accurate.
S104, respectively judging a period difference value between the tested basic period and an amplitude difference value between the tested amplitude and the tested amplitude according to a judgment standard corresponding to the anti-electromagnetic continuous failure test item, and obtaining a test result of the cardiac pacemaker under the test parameters and the signal source parameters.
Optionally, S104 includes: judging whether the period difference value is within a preset period error range; judging whether the amplitude difference value is within a preset amplitude error range or not; and when the period difference value is within the preset period error range and the amplitude difference value is within the preset amplitude error range, the test result is passed, otherwise, the test result is not passed.
Specifically, the preset period error range and the preset amplitude error range are set according to the test requirements, for example: the preset period error range is plus or minus 20ms, and the preset amplitude error range is plus or minus 10% of the amplitude before the test.
The basic period before the test is compared with the basic period after the test, and the amplitude before the test is compared with the amplitude after the test, so that whether the cardiac pacemaker still can normally work is mainly judged, and the basic period and the amplitude can reflect whether the cardiac pacemaker normally works.
Optionally, after the test result is obtained, the test result is imported into a corresponding file (for example, a txt file) and stored in a preset database, so that subsequent calling and synchronization are facilitated. The sample number of each active 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 tests half, the test system is moved to another test system for testing, and after data synchronization, the test can be carried out without re-testing, 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, the base period and amplitude before the testing, the base period and amplitude after the testing, and the testing result. And the signal frequency of the test signal currently sent by the test signal generator, the connection relation among 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 manually 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 signal frequency is continuously sent, but the timing of the preset time is stopped; when a starting instruction is received, timing of the preset time of the test signal corresponding to the current signal frequency 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 basic period and amplitude of the cardiac pacemaker after the cardiac pacemaker passes through a continuously fluctuating electromagnetic field are automatically read, whether the cardiac pacemaker can still normally work (namely whether the cardiac pacemaker passes the test) is judged, the sending of the whole test signals and the judgment of the test result can be automatically executed, manual participation is not needed, and the test efficiency is improved.
Fig. 2 shows another embodiment of the periodic amplitude testing method of the cardiac pacemaker according to the present invention, applied to a processing terminal, the method comprising the steps of:
s201, setting the test conditions corresponding to the anti-electromagnetic continuous failure test items, wherein the test conditions can be manually set by testers.
Specifically, the test conditions include: testing polarity, a test product running mode, a testing port and signal source parameters.
The test polarity includes: unipolar, bipolar differential mode, and bipolar common mode.
The test product operation modes (selected according to the model and performance of the cardiac pacemaker to be tested) include but are not limited to: 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 signal source parameters are set according to anti-interference test items, the signal source parameters comprise multiple groups of frequency information and signal output modes, and each group of frequency information comprises: signal amplitude, signal frequency, and dwell time. The frequency information is set in relation to the signal output mode.
After the processing terminal acquires the test conditions, the connection control module and the cardiac pacemaker are automatically controlled to carry out corresponding connection switching, and relevant manual wiring is not required to be carried out manually according to the test conditions, so that the test efficiency is improved.
S202 acquiring the base period and amplitude before the cardiac pacemaker test includes: s212, after waiting for a preset time, the basic period and amplitude before testing of the cardiac pacemaker are obtained through testing.
Specifically, when acquiring the fundamental period and amplitude before the test, the waiting for the preset time is to ensure the accuracy of the acquired fundamental period and amplitude before the test (i.e., the fundamental period and amplitude when the electromagnetic field is not continuously fluctuating and normally works).
The preset time is equipment according to the test requirement, such as: 10 seconds, 15 seconds, etc.
And after the basic period and amplitude before the test are obtained, sending a test signal for testing.
S203, controlling a test signal generator to send corresponding test signals according to the signal source parameters in the test conditions, and obtaining the basic cycle and amplitude of the cardiac pacemaker after the test of each test signal includes:
s213, the test signal generator is controlled to send test signals corresponding to a plurality of groups of frequency information according to the signal output mode.
Specifically, when the signal output mode is frequency sweeping, the test signal generator is controlled to send test signals corresponding to multiple groups of frequency information in a frequency sweeping mode, the signal frequency in the multiple groups of frequency information is set between 16.6Hz and 140kHz, the frequency sweeping rate is ten times of a frequency range per minute, and the residence time in each group of frequency information is set according to the requirement.
When the signal output mode is dot frequency, the signal frequency in each group of frequency information is selected in the range of 16.6Hz and 20kHz, and at least four different frequencies with reasonable intervals (for example: 2Hz) are applied every ten-fold frequency interval; and the residence time per decade is not less than 60 seconds.
When the signal amplitude in each group of frequency information corresponding to the two signal output modes is set, the requirements are met: when the signal frequency is between 16.6Hz and 20kHz, the corresponding signal amplitude is 1V; the corresponding amplitude is f/20kHz x 1V at signal frequencies between 20kHz and 140 kHz.
S223, after all the test signals corresponding to the signal source parameters are sent, waiting for a preset time;
the S233 test results in the fundamental period and amplitude of the cardiac pacemaker after the test signal.
Specifically, after all the test signals are sent, the basic period and amplitude after the test are not immediately acquired, and the basic period and amplitude are acquired after waiting for the preset time.
The waiting preset time is the same as the waiting preset time when the basic period and the amplitude before the test are obtained, so that the consistency of the test conditions is ensured, and the accuracy of the test result is ensured.
Optionally, the process of testing the obtained fundamental period and amplitude comprises: and reading the measurement value of the average mode of the oscilloscope, and extracting the basic period and the amplitude. The data read in the average mode is more accurate.
S204, respectively judging a period difference value between the tested basic period and an amplitude difference value between the tested amplitude and the tested amplitude according to a judgment standard corresponding to the electromagnetic resistance continuous failure test item, and obtaining a test result of the cardiac pacemaker under the test parameters and the signal source parameters.
Optionally, S204 includes: judging whether the period difference value is within a preset period error range; judging whether the amplitude difference value is within a preset amplitude error range or not; and when the period difference value is within the preset period error range and the amplitude difference value is within the preset amplitude error range, the test result is passed, otherwise, the test result is not passed.
Specifically, the preset period error range and the preset amplitude error range are set according to the test requirements, for example: the preset period error range is plus or minus 20ms, and the preset amplitude error range is plus or minus 10% of the amplitude before the test.
Optionally, after the test result is obtained, the test result is imported into a corresponding file (for example, a txt file) 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, the base period and amplitude before the testing, the base period and amplitude after the testing, and the testing result. And the signal frequency of the test signal currently sent by the test signal generator, the connection relation among 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 signal source can be manually controlled by the control button during the test. For specific examples, refer to the above method embodiments.
In the embodiment, the same waiting time is used for obtaining the basic period and amplitude before and after the test, and the conditions for obtaining the basic period and amplitude are ensured to be the same, so that the accuracy of the subsequent test result is ensured; the frequency information in the signal source parameters and the signal output mode have relevance, so that the cardiac pacemaker can be tested under test signals under different conditions, and the test is more comprehensive and diversified; in the whole testing process, the testing system can automatically complete the testing without manual intervention, and the testing efficiency is greatly improved.
Fig. 4 shows an embodiment of the processing terminal of the present invention, the processing terminal is electrically connected to a switching device for cardiac pacemaker induction 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, and the processing terminal comprises:
the obtaining module 10 is configured to obtain a test condition corresponding to the anti-electromagnetic sustained failure test item, and the test condition may be manually set by a tester.
Specifically, the cardiac pacemaker device is suitable for testing in multiple modes based on the structural design thereof, and therefore, the test conditions include: testing polarity, a test product running mode, a testing port and signal source parameters.
The test polarity includes: unipolar, bipolar differential mode, and bipolar common mode.
The test product operation modes (selected according to the model and performance of the cardiac pacemaker to be tested) include but are not limited to: 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 signal source parameters are set according to the anti-electromagnetic continuous failure test item, the signal source parameters comprise a plurality of groups of frequency information and signal output modes, and each group of frequency information comprises: signal amplitude, signal frequency, and dwell time. Wherein, the dwell time has different requirements according to the signal output mode.
For example: and when the signal output mode is frequency sweeping, controlling the test signal generator to send test signals corresponding to a plurality of groups of frequency information in a frequency sweeping mode, setting the signal frequency in the plurality of groups of frequency information between 16.6Hz and 140kHz, setting the frequency sweeping rate to be ten times of frequency per minute, and setting the residence time in each group of frequency information according to the requirement.
When the signal output mode is dot frequency, the signal frequency in each group of frequency information is selected in the range of 16.6Hz and 20kHz, and at least four different frequencies with reasonable intervals (for example: 2Hz) are applied every ten-fold frequency interval; and the residence time per decade is not less than 60 seconds.
When the signal amplitude in each group of frequency information corresponding to the two signal output modes is set, the requirements are met: when the signal frequency is between 16.6Hz and 20kHz, the corresponding signal amplitude is 1V; the corresponding amplitude is f/20kHz x 1V at signal frequencies between 20kHz and 140 kHz.
The setting of the multiple groups of frequency information is to test that the cardiac pacemaker does not generate faults after experiencing continuously fluctuating electromagnetic fields; meanwhile, the arrangement of the multiple groups of frequency information enables the cardiac pacemaker to experience various electromagnetic fields, and the referential property of the test result is ensured.
After the processing terminal obtains the test condition, the control module 30 can automatically control the connection control module and the cardiac pacemaker to perform corresponding connection switching according to the test condition, and related manual wiring according to the test condition is not needed, so that the test efficiency is improved.
And a test module 20 for obtaining the basic period and amplitude before the cardiac pacemaker test.
Specifically, before the cardiac pacemaker is not exposed to a continuously fluctuating electromagnetic field, the normal basic cycle and amplitude of the cardiac pacemaker are tested for subsequent comparison to determine whether the cardiac pacemaker is working normally.
Optionally, the testing module 20, configured to obtain the basic period and amplitude before the cardiac pacemaker test includes: after waiting for a preset time, the test module 20 obtains the basic period and amplitude before the cardiac pacemaker test.
Specifically, when acquiring the fundamental period and amplitude before the test, the waiting for the preset time is to ensure the accuracy of the acquired fundamental period and amplitude before the test (i.e., the fundamental period and amplitude when the electromagnetic field is not continuously fluctuating and normally works).
The preset time is equipment according to the test requirement, such as: 10 seconds, 15 seconds, etc.
And after the basic period and amplitude before the test are obtained, sending a test signal for testing.
And the control module 30 is used for controlling the test signal generator to send the corresponding test signal according to the signal source parameter in the test condition.
Specifically, the test signal corresponding to the signal source parameter is a sinusoidal signal.
Optionally, the controlling module 30 is configured to control the test signal generator to send the corresponding test signal according to the signal source parameter in the test condition, and the controlling module includes: and the control module 30 is used for controlling the test signal generator to send test signals corresponding to a plurality of groups of frequency information according to the signal output mode.
The test module 20 is further configured to obtain a basic period and an amplitude of the cardiac pacemaker after the test of each test signal.
Specifically, after the cardiac pacemaker has undergone a plurality of test signals, the basic period and amplitude after the test are obtained and compared with the basic period and amplitude before the test, respectively, to determine whether the cardiac pacemaker still works normally after the electromagnetic field is removed after the cardiac pacemaker has undergone a continuously fluctuating electromagnetic field.
Optionally, the testing module 20, further configured to test the fundamental period and amplitude of the cardiac pacemaker after the test of each test signal, includes:
the test module 20 waits for a preset time after all test signals corresponding to the signal source parameters are sent; and testing to obtain the basic period and amplitude of the cardiac pacemaker after each test signal is tested.
Specifically, after all the test signals are sent, the basic period and amplitude after the test are not immediately acquired, and the basic period and amplitude are acquired after waiting for the preset time.
The waiting preset time is the same as the waiting preset time when the basic period and the amplitude before the test are obtained, so that the consistency of the test conditions is ensured, and the accuracy of the test result is ensured.
Optionally, the testing module 20, the process of testing the obtained fundamental period and amplitude includes: the test module 20 reads the measurement value of the average mode of the oscilloscope and extracts the fundamental period and the amplitude. The data read in the average mode is more accurate.
And the judging module 40 is configured to respectively judge a period difference between the tested basic period and an amplitude difference between the tested amplitude and the tested amplitude according to a judging standard corresponding to the electromagnetic resistance sustained failure test item, so as to obtain a test result of the cardiac pacemaker under the test condition.
Optionally, the determining module 40 is configured to respectively determine, according to a determination standard corresponding to the anti-electromagnetic persistent failure test item, a period difference between the tested basic period and the basic period before the test, and an amplitude difference between the tested amplitude and the amplitude before the test, and obtain a test result of the cardiac pacemaker under the test condition includes: the judging module 40 is used for judging whether the period difference value is within a preset period error range; judging whether the amplitude difference value is within a preset amplitude error range or not; and when the period difference value is within the preset period error range and the amplitude difference value is within the preset amplitude error range, the test result is passed, otherwise, the test result is not passed.
Specifically, the preset period error range and the preset amplitude error range are set according to the test requirements, for example: the preset period error range is plus or minus 20ms, and the preset amplitude error range is plus or minus 10% of the amplitude before the test.
The basic period before the test is compared with the basic period after the test, and the amplitude before the test is compared with the amplitude after the test, so that whether the cardiac pacemaker still can normally work is mainly judged, and the basic period and the amplitude can reflect whether the cardiac pacemaker normally works.
Optionally, after the test result is obtained, the processing terminal imports the test result into a corresponding file (for example, a txt file) and stores the test result into 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: the cloud database (the file is sent to the cloud database by a sending module on the processing terminal), the Access database (stored by a storage module on the processing terminal) and the like are set according to actual conditions.
Optionally, the processing terminal further includes: and the display module displays the sample number of the currently tested cardiac pacemaker, the input test condition, the basic period and amplitude before testing, the basic period and amplitude after testing and the test result in the test process. And the signal frequency of the test signal currently sent by the test signal generator, the connection relation among the switching equipment, the processing terminal, the oscilloscope and the cardiac pacemaker and the like can also be displayed.
Optionally, control buttons of the signal source are displayed on the processing terminal. That is, the signal source can be manually controlled by the control button 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 send the test signal and read the basic period and amplitude on the oscilloscope, so that whether the cardiac pacemaker can still work normally (i.e. whether the cardiac pacemaker fails) after the cardiac pacemaker passes through a continuously fluctuating electromagnetic field is automatically tested, the sending of the whole test signal and the judgment of the test result can be automatically executed without human participation, and the test efficiency is improved.
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 (10)
1. A method for testing the anti-electromagnetic continuous failure 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, and an oscilloscope is electrically connected with the switching device, and the method comprises the following steps:
s1, setting test conditions corresponding to the electromagnetic resistance continuous failure test items;
s2 obtaining a basic period and amplitude before the cardiac pacemaker test;
s3, controlling the test signal generator to send corresponding test signals according to the signal source parameters in the test conditions, and obtaining the basic period and amplitude of the cardiac pacemaker after the test of each test signal;
s4, respectively judging a period difference value between the tested basic period and an amplitude difference value between the tested amplitude and the tested amplitude according to a judgment standard corresponding to the anti-electromagnetic continuous failure test item, and obtaining a test result of the cardiac pacemaker under the test condition.
2. The method for testing a cardiac pacemaker against electromagnetic sustained failure according to claim 1, wherein said step S2 comprises:
and after waiting for a preset time, testing to obtain the basic period and amplitude before testing of the cardiac pacemaker.
3. The method for testing a cardiac pacemaker against electromagnetic sustained failure according to claim 2, wherein said step S3 comprises:
controlling the test signal generator to send corresponding test signals according to the signal source parameters in the test conditions;
waiting for a preset time after all the test signals corresponding to the signal source parameters are sent;
and testing to obtain the basic period and amplitude of the cardiac pacemaker after each test signal is tested.
4. The method of claim 1, wherein the testing method for resistance to sustained electromagnetic failure of a cardiac pacemaker comprises:
the signal source parameters include: a plurality of groups of frequency information and signal output modes;
the step S3 of controlling the test signal generator to send the corresponding test signal according to the signal source parameter in the test condition includes:
and controlling the test signal generator to send test signals corresponding to a plurality of groups of frequency information according to the signal output mode.
5. The method for testing a cardiac pacemaker against electromagnetic sustained failure according to claim 1, wherein said step S4 comprises:
judging whether the period difference value is within a preset period error range or not;
judging whether the amplitude difference value is within a preset amplitude error range or not;
and when the period difference value is within a preset period error range and the amplitude difference value is within a preset amplitude error range, the test result is passed, otherwise, the test result is not passed.
6. 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 acquisition module is used for acquiring test conditions corresponding to the electromagnetic resistance continuous failure test item;
the test module is used for acquiring a basic period and amplitude before the test of the cardiac pacemaker;
the control module is used for controlling the test signal generator to send corresponding test signals according to the signal source parameters in the test conditions;
the test module is further used for testing to obtain the basic period and amplitude of the cardiac pacemaker after the test of each test signal;
and the judging module is used for respectively judging a period difference value between the tested basic period and an amplitude difference value between the tested amplitude and the tested amplitude according to a judging standard corresponding to the anti-electromagnetic continuous failure testing item, so as to obtain a testing result of the cardiac pacemaker under the testing condition.
7. The processing terminal of claim 6, wherein the testing module to obtain the base period and amplitude before the cardiac pacemaker test comprises:
and the test module is used for obtaining the basic period and amplitude before the test of the cardiac pacemaker after waiting for the preset time.
8. The processing terminal of claim 7, wherein the testing module further configured to test a fundamental period and amplitude of the cardiac pacemaker after each of the test signals comprises:
the test module waits for a preset time after all test signals corresponding to the signal source parameters are sent; and testing to obtain the basic period and amplitude of the cardiac pacemaker after each test signal is tested.
9. The processing terminal of claim 6, wherein the signal source parameters comprise: a plurality of groups of frequency information and signal output modes;
the control module is configured to control the test signal generator to send the corresponding test signal according to the signal source parameter in the test condition, and the control module includes:
and the control module controls the test signal generator to send test signals corresponding to a plurality of groups of frequency information according to the signal output mode.
10. The processing terminal of claim 6, wherein the determining module is configured to determine, according to a determination criterion corresponding to the anti-electromagnetic sustained failure test item, a period difference between the base period after the test and the base period before the test and an amplitude difference between the amplitude after the test and the amplitude before the test, respectively, and obtain the test result of the cardiac pacemaker under the test condition includes:
the judging module is used for judging whether the period difference value is within a preset period error range; judging whether the amplitude difference value is within a preset amplitude error range or not; and when the period difference value is within a preset period error range and the amplitude difference value is within a preset amplitude error range, the test result is passed, otherwise, the test result is not passed.
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