CN112870550A - Failure analysis method for cochlear implant - Google Patents
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- CN112870550A CN112870550A CN202110048189.1A CN202110048189A CN112870550A CN 112870550 A CN112870550 A CN 112870550A CN 202110048189 A CN202110048189 A CN 202110048189A CN 112870550 A CN112870550 A CN 112870550A
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- 239000007943 implant Substances 0.000 title claims abstract description 120
- 238000004458 analytical method Methods 0.000 title claims abstract description 98
- 238000012360 testing method Methods 0.000 claims abstract description 140
- 210000003477 cochlea Anatomy 0.000 claims abstract description 13
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 22
- 238000005259 measurement Methods 0.000 claims description 18
- 239000004065 semiconductor Substances 0.000 claims description 18
- 239000002504 physiological saline solution Substances 0.000 claims description 12
- 238000000034 method Methods 0.000 claims description 11
- 230000000638 stimulation Effects 0.000 claims description 9
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 7
- 230000002159 abnormal effect Effects 0.000 claims description 7
- 239000000741 silica gel Substances 0.000 claims description 7
- 229910002027 silica gel Inorganic materials 0.000 claims description 7
- 230000008569 process Effects 0.000 claims description 6
- 239000001307 helium Substances 0.000 claims description 5
- 229910052734 helium Inorganic materials 0.000 claims description 5
- SWQJXJOGLNCZEY-UHFFFAOYSA-N helium atom Chemical compound [He] SWQJXJOGLNCZEY-UHFFFAOYSA-N 0.000 claims description 5
- 239000007789 gas Substances 0.000 claims description 4
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 claims description 3
- 238000003860 storage Methods 0.000 claims description 3
- 229910052719 titanium Inorganic materials 0.000 claims description 3
- 239000010936 titanium Substances 0.000 claims description 3
- 238000004140 cleaning Methods 0.000 claims description 2
- 238000001035 drying Methods 0.000 claims description 2
- 238000003466 welding Methods 0.000 claims description 2
- 230000001351 cycling effect Effects 0.000 claims 2
- 208000037408 Device failure Diseases 0.000 abstract description 2
- 238000004519 manufacturing process Methods 0.000 abstract description 2
- 239000000523 sample Substances 0.000 description 8
- 238000010586 diagram Methods 0.000 description 7
- 238000011056 performance test Methods 0.000 description 7
- 238000010998 test method Methods 0.000 description 5
- 230000008901 benefit Effects 0.000 description 3
- 230000004048 modification Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 238000006467 substitution reaction Methods 0.000 description 2
- 230000004075 alteration Effects 0.000 description 1
- 210000003484 anatomy Anatomy 0.000 description 1
- 230000008878 coupling Effects 0.000 description 1
- 238000010168 coupling process Methods 0.000 description 1
- 238000005859 coupling reaction Methods 0.000 description 1
- 238000002224 dissection Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36036—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of the outer, middle or inner ear
- A61N1/36038—Cochlear stimulation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36036—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of the outer, middle or inner ear
- A61N1/36038—Cochlear stimulation
- A61N1/36039—Cochlear stimulation fitting procedures
Abstract
The invention provides a failure analysis method of a cochlear implant. The artificial cochlea implant failure analysis method comprises the following steps: ID telemetry, impedance telemetry, compliance testing, and testing of stimulus output. The invention provides a failure analysis method of a cochlear implant, which aims to solve the problems of difficult and inaccurate positioning of failure reasons of the existing failure analysis method of the cochlear implant and effectively improve the yield of the cochlear implant in mass production.
Description
Technical Field
The invention relates to the technical field of cochlear implant, in particular to a failure analysis method of cochlear implant.
Background
At present, the artificial cochlea implant body is failed in the using or production process, and the failure reason needs to be positioned. Because the artificial cochlea implant has a plurality of components, different analysis technologies are required for the failure of different components, and therefore the problems of difficult positioning and inaccurate positioning of the failure analysis reason of the artificial cochlea are faced.
Disclosure of Invention
In view of the above, the invention provides a failure analysis method for a cochlear implant, and aims to solve the problems of difficult and inaccurate positioning of failure reasons in the existing failure analysis of the cochlear implant.
The invention provides a failure analysis method of a cochlear implant, which comprises the following steps: and analyzing the electrical property of the cochlear implant, wherein the analysis process of the electrical property comprises the test processes of ID remote measurement, impedance remote measurement, compliance test and stimulation output.
Further, the testing process of the ID telemetry, the impedance telemetry, the compliance test and the stimulation output test comprises the following steps:
executing ID remote measurement, if the test result is normal, ending, and if the test result is abnormal, continuing the following test;
performing impedance remote measurement, placing the cochlear implant electrode in physiological saline, if the impedance remote measurement result is more than or equal to 20000 omega, judging that the cochlear implant electrode is open-circuited, or placing the cochlear implant electrode in air, and if the impedance remote measurement result is less than or equal to 20000 omega, judging that the cochlear implant electrode has a short-circuit condition;
performing a compliance test, setting the test amplitude to be 255cl, placing the cochlear implant electrode in physiological saline, if the test current is 0 or less than 1500 muA, indicating that the compliance test of the implant is abnormal, judging that the chip or the electrode has an open circuit or a semi-open circuit state, or placing the cochlear implant electrode in the air, and if the test current is more than 50 muA, judging that the chip or the electrode has a short circuit condition;
and executing a stimulation output test, measuring the signal amplitude output by the electrode, and judging whether a forward decoding circuit of the cochlear implant has a fault or not according to the signal amplitude.
Furthermore, the failure analysis method further comprises the step of performing frequency sweep analysis on the cochlear implant to judge whether the resonant circuit of the implant has a fault.
Further, the failure analysis method also comprises the step of positioning whether the cochlear implant electrode has a short circuit or not through leakage current analysis, and the leakage current analysis method comprises the following steps:
placing the cochlear implant electrode in the air, immersing other parts in physiological saline, executing compliance test, analyzing whether the cochlear implant has short circuit condition or not according to the compliance test result, if so, ending the analysis of leakage current, otherwise, continuing the following test;
placing all electrodes of the cochlear implant in physiological saline, executing compliance test in debugging software, judging and analyzing compliance output current of the cochlear implant according to a compliance test result, if the cochlear implant is normal, finishing leakage current analysis, and otherwise, continuing the following test;
placing the electrode with the electrode number from the initial value to the specific value in the air, wherein the specific value is larger than the initial value and smaller than the total number of the electrodes, executing a compliance test, analyzing whether the electrode with the electrode number from the initial value to the specific value of the implant is in short circuit with other electrodes or not according to the compliance test result, if so, finishing the analysis of leakage current, otherwise, continuing the following test;
placing the electrode with the electrode number from the initial value to the specific value plus the increment value in the air, executing a compliance test, analyzing whether the electrode with the electrode number from the initial value to the specific value plus the increment value has a short circuit condition with other electrodes or not according to the compliance test result, if so, finishing the analysis of leakage current, otherwise, continuing to increase the electrode according to the increment value on the basis, executing the compliance test on the electrode with the electrode number from the initial value to the specific value plus the integral multiple increment value, and executing the following test until the number of the remaining electrodes is not enough than the increment value;
and (3) placing the electrodes from the number of the electrodes of the cochlear implant as an initial value to the total number of the electrodes in the air, executing a compliance test, and analyzing whether short circuit exists at other parts of the cochlear implant except the electrodes according to the compliance test result.
Further, the failure analysis method further includes a step of a cycle test, and the cycle test method includes:
the cochlear implant is sequentially placed in a water bath at 90-100 ℃ and an oven at 80-90 ℃ for 40-50 hours for storage test each time, electrical property test and data comparison are carried out after each time, whether the cochlear implant is affected by water vapor or not is judged according to the data, and the steps are repeated for 2-3 times.
Further, the failure analysis method further includes an anatomical analysis, and the step of the anatomical analysis includes a first step of: peeling off the silica gel of the cochlear implant, opening the titanium shell and checking the welding condition of the receiving coil.
Further, the step of analyzing the anatomy further includes a second step of: stripping the electrode, cleaning the silica gel of the stimulator and drying the electrode and the silica gel.
Further, the failure analysis method further includes a gas tightness analysis, and the gas tightness analysis includes: the cochlear implant is stored for 2 to 3 hours in an environment filled with helium at 3 to 4 atmospheric pressures, and then whether gas leakage occurs is detected by a helium mass spectrometer leak detector.
Further, the failure analysis method further comprises semiconductor characteristic analysis, wherein after the semiconductor analyzer is connected with the IO and the ground of the cochlear implant, the semiconductor characteristic analysis sequentially carries out ground semiconductor characteristic analysis on all input and output ends, and whether the IO has the diode characteristic is detected.
Compared with the prior art, the method for analyzing the failure of the cochlear implant has the advantages that the failure reason of the cochlear implant can be quickly and effectively positioned through the multidirectional different combination of electrical property test analysis, scanning analysis, leakage current analysis, cycle test, dissection analysis, air tightness analysis and semiconductor characteristic analysis.
Drawings
Various other advantages and benefits will become apparent to those of ordinary skill in the art upon reading the following detailed description of the preferred embodiments. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the invention. Also, like reference numerals are used to refer to like parts throughout the drawings. In the drawings:
fig. 1 is a schematic overall flow chart of a failure analysis method for a cochlear implant according to an embodiment of the present invention;
FIG. 2 is a schematic diagram of electrical property analysis provided by an embodiment of the present invention;
FIG. 3 is a schematic diagram of an analysis of leakage current according to an embodiment of the present invention;
FIG. 4 is a schematic diagram of a cycle test provided by an embodiment of the present invention;
FIG. 5 is a schematic diagram of semiconductor characteristic analysis according to an embodiment of the present invention.
Detailed Description
Exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art. It should be noted that the embodiments and features of the embodiments may be combined with each other without conflict. The present invention will be described in detail below with reference to the embodiments with reference to the attached drawings.
Referring to fig. 1, an overall flow chart of the cochlear implant failure analysis method according to the embodiment of the present invention is shown, which includes: electrical property analysis, frequency sweep analysis, leakage current analysis, cycle testing, anatomical analysis, airtightness analysis and semiconductor characteristic analysis.
Electrical performance analysis, refers to test analysis of basic function and performance, and includes cochlear implant ID telemetry analysis, stimulation output test analysis, impedance telemetry analysis, and implant compliance test analysis. The failure mechanism of the implant is located by electrical property analysis.
And (3) performing frequency sweep analysis, namely performing frequency sweep test on the cochlear implant by using a signal analyzer, and testing whether the natural frequency of the cochlear implant has deviation or not to judge the integrity of the receiving circuit of the cochlear implant.
Analyzing leakage current, namely, putting all electrodes of the cochlear implant in an open circuit state, namely, putting the cochlear implant in the air, carrying out implant compliance current test by using cochlear implant debugging software, and checking a current value fed back by the cochlear implant, wherein the current value at the moment is the leakage current. And if the current leakage is 0 or less than 20 muA, performing a current leakage test on the electrode segment of the artificial cochlear implant, and analyzing whether a short circuit exists in a certain segment.
And (3) performing cycle test, namely placing the cochlear implant in a 95 ℃ water bath and an 85 ℃ oven in sequence to perform 48-hour storage test, performing electrical performance test after each time, performing cycle twice, and comparing data of the cycle test.
And (4) carrying out anatomical analysis, namely dissecting the sealing silica gel and the titanium shell of the artificial cochlea implant body, and further carrying out test analysis on the internal circuit.
And (3) performing airtightness analysis, namely performing airtightness test on the implant stimulator by using a helium mass spectrometer leak detector, and verifying the airtightness index condition of the stimulator.
And semiconductor characteristic analysis, namely, carrying out semiconductor characteristic test on the internal circuit of the stimulator by using a semiconductor analyzer, and analyzing whether a semiconductor device in the circuit breaks down or not.
Fig. 2 is a schematic diagram of a connection of an analysis system according to an embodiment of the present invention. The implanted part is a tested sample, the voice processor is connected with a computer provided with artificial cochlea debugging software through an adapter, the transmitting coil of the voice processor is connected with the receiving coil of the implanted part in a wireless coupling mode, the electrode channel of the implanted part is provided with a 1k omega resistor, and the oscilloscope probe can be connected with any one electrode channel. The receiving coil of the artificial cochlea implant body in the analysis test system is coupled with the transmitting coil of the test sound processor, and the electrode end of the artificial cochlea implant body is provided with a standard load. The specific analysis steps of the electrical property analysis are as follows:
executing ID remote measurement in debugging software, and judging and analyzing an ID remote measurement circuit of the artificial cochlea implant according to an ID remote measurement result, wherein the analysis is as follows: if the result is a character of a combination of a numerical value and a letter, the ID telemetry circuit is normal, if the result is FFFFF, the ID telemetry circuit is abnormal, at the moment, a preliminary judgment can be made on the telemetry circuit, and the following steps are executed.
Executing impedance remote measurement in debugging software, and judging and analyzing an impedance remote measurement circuit of the artificial cochlea implant body according to an impedance remote measurement result: placing the cochlear implant electrode in physiological saline, and judging that the cochlear implant electrode is open-circuited if the impedance remote measurement result is more than or equal to 20000 omega; and (3) placing the cochlear implant electrode in air, wherein if the impedance remote measurement result is less than or equal to 20000 omega, the cochlear implant electrode is short-circuited. The following steps are performed.
Performing compliance test in debugging software, and judging and analyzing a current source circuit of the artificial cochlea implant according to an implant compliance test result: placing the cochlear implant electrode in physiological saline, executing a compliance test, setting the test amplitude to be 255CL, and if the test current is 0 or less than 1500 muA, indicating that the cochlear implant compliance test is abnormal, thereby judging that the chip or the electrode has an open circuit or a semi-open circuit state; and (3) placing the cochlear implant electrode in the air, performing compliance test, and setting the test amplitude to be 255CL, if the test current is greater than 50 muA, judging that the chip or the electrode has a short circuit condition. The following steps are performed.
The stimulus output test was performed in the debug software, and the signal amplitude output by the electrode was measured using an oscilloscope. By measuring the amplitude and the width of the waveform output by the cochlear implant, if the amplitude or the width of the output waveform is abnormal, the forward decoding circuit of the cochlear implant is indicated to have a fault.
Fig. 3 is a schematic view of a leakage current analysis process according to the present invention. The analysis steps are as follows:
the artificial cochlea implant electrode is placed in the air, other parts are immersed in physiological saline, a compliance test is executed in debugging software, whether the inside of the implant is short-circuited or not is analyzed according to the compliance test result, if yes, the leakage current analysis is ended, and if not, the following steps are executed.
And (3) placing all electrodes of the cochlear implant into physiological saline, executing compliance test in debugging software, judging and analyzing compliance output current of the cochlear implant according to a compliance test result, and if the cochlear implant is normal, finishing leakage current analysis, otherwise, executing the following steps.
And (3) placing the No. 1-5 electrode of the cochlear implant in the air, executing a compliance test in debugging software, analyzing whether the No. 1-5 electrode of the cochlear implant is in short circuit with other electrodes or not according to a compliance test result, if so, finishing the analysis of leakage current, and otherwise, executing the following steps.
And (3) placing the No. 1-15 electrode of the cochlear implant in the air, executing a compliance test in debugging software, analyzing whether the No. 1-15 electrode of the cochlear implant is in short circuit with other electrodes or not according to a compliance test result, if so, finishing the analysis of leakage current, and otherwise, executing the following steps.
The No. 1-22 electrode of the cochlear implant is placed in the air, a compliance test is executed in debugging software, and whether short circuit conditions exist at other parts of the cochlear implant except the electrode is analyzed according to the compliance test result.
Fig. 4 is a schematic diagram of the cycle test provided by the present invention. The test procedure was as follows: placing the failed implant in a water bath at 95 ℃ for 48 hours, taking out the failed implant, performing an electrical performance test according to an electrical performance test method, and recording test data; and (3) baking the cochlear implant in an oven at 85 ℃ for 48 hours, taking out, testing the electrical property according to an electrical property testing method, and recording test data. And (4) circulating the first two steps twice, comparing data of four tests, and observing whether the data is influenced by moisture. And comparing the data, and if the conditions in the following table are met, indicating that the sample is influenced by water vapor, so that the sample is judged to have poor air tightness. Otherwise, the influence of the water vapor is avoided.
Test procedure | Test results |
Test after first water bath at 95 ℃ for 48 hours | Data exceptions |
Test after 48 hours in the first 85 ℃ oven | Data returns to normal or tends to normal |
Second test in a 95 ℃ water bath for 48 hours | Data exceptions |
Second 85 ℃ oven 48 hours later test | Data returns to normal or tends to normal |
The water bath temperature, the oven temperature and the standing time were changed, and the test was continued as follows: placing the failed implant in a water bath at 90 ℃ for 40 hours, taking out the failed implant, performing an electrical performance test according to an electrical performance test method, and recording test data; and (3) baking the cochlear implant in an oven at 80 ℃ for 40 hours, taking out, testing the electrical performance according to an electrical performance testing method, and recording test data. And (4) circulating the first two steps twice, comparing data of four tests, and observing whether the data is influenced by moisture. And comparing the data, and if the conditions in the following table are met, indicating that the sample is influenced by water vapor, so that the sample is judged to have poor air tightness. Otherwise, the influence of the water vapor is avoided.
Test procedure | Test results |
Test after 40 hours in a first 90 ℃ water bath | Data exceptions |
First 80 ℃ oven 40 hours later test | Data returns to normal or tends to normal |
Second 90 ℃ water bath for 40 hours and then testing | Data exceptions |
Second 80 ℃ oven 40 hours later test | Data returns to normal or tends to normal |
The water bath temperature, the oven temperature and the standing time were changed, and the test was continued as follows: placing the failed implant in a water bath at 100 ℃ for 50 hours, taking out the failed implant, performing an electrical performance test according to an electrical performance test method, and recording test data; and (3) baking the cochlear implant in a 90 ℃ oven for 50 hours, taking out, testing the electrical performance according to an electrical performance testing method, and recording test data. And (4) circulating the first two steps twice, comparing data of four tests, and observing whether the data is influenced by moisture. And comparing the data, and if the conditions in the following table are met, indicating that the sample is influenced by water vapor, so that the sample is judged to have poor air tightness. Otherwise, the influence of the water vapor is avoided.
Test procedure | Test results |
Test after 50 hours in a first 100 ℃ water bath | Data exceptions |
First 90 ℃ oven 50 hours later test | Data returns to normal or tends to normal |
Second 100 ℃ water bath for 50 hours and then testing | Data exceptions |
Second 90 ℃ oven 50 hours later test | Data returns to normal or tends to normal |
Referring to fig. 5, a schematic diagram of semiconductor characteristic analysis according to the present invention is shown. The Force1 on the semiconductor analyzer is connected with an I/O port of the cochlear implant stimulation circuit after being in short circuit with the sequence 2, the Force3 is connected with the ground of the cochlear implant stimulation circuit after being in short circuit with the sequence 4, and all input and output ends of the stimulation chip are subjected to semiconductor characteristic analysis and test on the ground in sequence. If the test result has no diode characteristic, the I/O port diode protection is invalid.
So far, the technical solutions of the present invention have been described in connection with the preferred embodiments shown in the drawings, but it is easily understood by those skilled in the art that the scope of the present invention is obviously not limited to these specific embodiments. Equivalent changes or substitutions of related technical features can be made by those skilled in the art without departing from the principle of the invention, and the technical scheme after the changes or substitutions can fall into the protection scope of the invention.
The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention; various modifications and alterations to this invention will become apparent to those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (9)
1. A failure analysis method of a cochlear implant is characterized by comprising the following steps: analyzing the electrical properties of the cochlear implant, including testing processes for ID telemetry, impedance telemetry, compliance testing, and stimulation output.
2. The failure analysis method of claim 1, wherein the testing process of ID telemetry, impedance telemetry, compliance testing, and stimulus output testing comprises the steps of:
executing ID remote measurement, if the test result is normal, ending, and if the test result is abnormal, continuing the following test;
performing impedance remote measurement, placing the cochlear implant electrode in physiological saline, if the impedance remote measurement result is more than or equal to 20000 omega, judging that the cochlear implant electrode is open-circuited, or placing the cochlear implant electrode in air, and if the impedance remote measurement result is less than or equal to 20000 omega, judging that the cochlear implant electrode has a short-circuit condition;
performing a compliance test, setting the test amplitude to be 255CL, placing the cochlear implant electrode in physiological saline, if the test current is 0 or less than 1500 muA, indicating that the compliance test of the implant is abnormal, judging that the chip or the electrode has an open circuit or a semi-open circuit state, or placing the cochlear implant electrode in the air, and if the test current is more than 50 muA, judging that the chip or the electrode has a short circuit condition;
and executing a stimulation output test, measuring the signal amplitude output by the electrode, and judging whether a forward decoding circuit of the cochlear implant has a fault or not according to the signal amplitude.
3. The failure analysis method according to claim 1 or 2, further comprising performing a frequency sweep analysis on the cochlear implant to determine whether there is a failure in the implant resonant circuit.
4. The failure analysis method according to claim 3, further comprising locating whether there is a short circuit in the cochlear implant electrode by a leakage current analysis, the leakage current analysis method comprising the steps of:
placing the cochlear implant electrode in the air, immersing other parts in physiological saline, executing compliance test, analyzing whether the cochlear implant has short circuit condition or not according to the compliance test result, if so, ending the analysis of leakage current, otherwise, continuing the following test;
placing all electrodes of the cochlear implant in physiological saline, executing compliance test in debugging software, judging and analyzing compliance output current of the cochlear implant according to a compliance test result, if the cochlear implant is normal, finishing leakage current analysis, and otherwise, continuing the following test;
placing the electrode with the initial value to the specific value of the artificial cochlea implant body number in the air, wherein the specific value is larger than the initial value and smaller than the total number of the electrodes, executing a compliance test, analyzing whether the electrode with the initial value to the specific value of the implant body number is short-circuited with other electrodes or not according to a compliance test result, if so, finishing the analysis of leakage current, otherwise, continuing the following test;
placing the electrode with the electrode number from the initial value to the specific value plus the increment value in the air, executing a compliance test, analyzing whether the electrode with the electrode number from the initial value to the specific value plus the increment value has a short circuit condition with other electrodes or not according to the compliance test result, if so, finishing the analysis of leakage current, otherwise, continuing to increase the electrode according to the increment value on the basis, executing the compliance test on the electrode with the electrode number from the initial value to the specific value plus the integral multiple increment value, and executing the following test until the number of the remaining electrodes is not enough than the increment value;
and (3) placing the electrodes with the electrode number of the cochlear implant as an initial value to the total number of the electrodes in the air, executing a compliance test, and analyzing whether short circuit exists at other parts of the cochlear implant except the electrodes according to the compliance test result.
5. The failure analysis method according to claim 4, further comprising the step of cycling a test, the method of cycling comprising: the cochlear implant is sequentially placed in a water bath at 90-100 ℃ and an oven at 80-90 ℃ for 40-50 hours for storage test each time, electrical property test and data comparison are carried out after each time, whether the cochlear implant is affected by water vapor or not is judged according to the data, and the steps are repeated for 2-3 times.
6. The failure analysis method according to claim 5, further comprising an anatomical analysis, the step of anatomical analysis comprising a first step of: peeling off the silica gel of the cochlear implant, opening the titanium shell and checking the welding condition of the receiving coil.
7. The failure analysis method according to claim 6, wherein the step of anatomically analyzing further comprises a second step of: stripping the electrode, cleaning the silica gel of the stimulator and drying the electrode and the silica gel.
8. The failure analysis method of claim 7, further comprising a hermeticity analysis, the step of hermeticity analysis comprising: the cochlear implant is stored for 2 to 3 hours in an environment filled with helium at 3 to 4 atmospheric pressures, and then whether gas leakage occurs is detected by a helium mass spectrometer leak detector.
9. The failure analysis method according to claim 8, further comprising semiconductor characteristic analysis, wherein after the semiconductor characteristic analysis connects the semiconductor analyzer with the IO and the ground of the cochlear implant, the semiconductor characteristic analysis is sequentially performed on all the input and output ends to the ground to detect whether the IO has diode characteristics.
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WO2019162837A1 (en) * | 2018-02-20 | 2019-08-29 | Cochlear Limited | Advanced electrode data analysis |
CN111228647A (en) * | 2020-02-25 | 2020-06-05 | 浙江诺尔康神经电子科技股份有限公司 | General communication method for cochlear implant system |
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Patent Citations (4)
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US20120303096A1 (en) * | 2008-12-23 | 2012-11-29 | Abhijit Kulkarni | Methods and systems of automatically detecting an impedance of one or more electrodes in a cochlear implant system |
WO2019162837A1 (en) * | 2018-02-20 | 2019-08-29 | Cochlear Limited | Advanced electrode data analysis |
CN209133683U (en) * | 2018-12-26 | 2019-07-19 | 吉林医药学院 | Wireless broadband circle polarized implanted antenna of the biologic medical equipment based on graphene |
CN111228647A (en) * | 2020-02-25 | 2020-06-05 | 浙江诺尔康神经电子科技股份有限公司 | General communication method for cochlear implant system |
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