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The KP-1230S Dielectric Strength Tester is a professional test instrument designed to generate test pulses. This device is engineered and manufactured in strict accordance with the requirements of Appendix C in YY/T 0972-2016, specifically for evaluating whether the quadripolar connector systems used in active implantable medical devices (such as implantable cardiac rhythm management devices) experience permanent damage when subjected to truncated exponential defibrillation waveforms and high-voltage pulse currents, and whether the device settings can be restored through reprogramming. The KP-1230S Dielectric Strength Testing System complies with YY/T 0972-2016 and ISO 27186:2010 standards.
Dielectric Strength Tester Measured Waveform Data (Monophasic Truncated Exponential Wave)
Parameter
Specification Value
Description
Test Signal Rise Time
1.4 μs
Fast rise time to simulate real defibrillation shocks
dV/dt
1.08 kV/μs
Voltage rate of change
Peak Voltage
1.53 kV
Maximum output voltage
Pulse Duration
18 ms
Total pulse width
Peak Voltage Decay Requirement
>50% of peak value after 18 ms
Complies with truncated exponential waveform decay characteristics
Dielectric Strength Tester
If you need a quotation, demonstration, or customization services for the KP-1230S Dielectric Strength Tester, please contact us. We are committed to providing high-quality medical device testing solutions!
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Application Scenarios
The KP-1230S Dielectric Strength Testing System is widely used in the following areas:
Medical Device R&D and Validation: Defibrillation resistance testing of connector systems in implantable pacemakers, ICDs, and CRT devices to ensure compliance with safety standards before market release.
Third-Party Testing Laboratories: Providing compliance certification testing services for manufacturers, supporting ISO 27186 and YY/T 0972 standard reports.
Quality Control and Production Testing: End-of-line sampling testing to verify dielectric strength and reprogramming recovery of batch products.
Clinical Simulation Research: Studying the effects of defibrillation shocks on implantable devices to optimize designs and improve patient safety.
In clinical practice, patients may receive external or internal defibrillation therapy. This system helps ensure that implanted devices will not suffer permanent damage under such high-voltage conditions, thereby protecting patient lives.
The rise time of the test signal is 1.4μs, with a rate of dV/dt = 1.08kV/μs.Single-phase truncated exponential wave: Peak voltage: 1.53 kV; Pulse duration: 18 ms; Peak voltage exceeds 50% of the peak amplitude 18ms after the peak.
Dielectric Strength Tester
FAQ (Frequently Asked Questions)
1. Which standards does the KP-1230S system support? The system is specifically designed for YY/T 0972-2016 (Appendix C) and ISO 27186:2020, used for defibrillation waveform endurance testing of quadripolar connector systems.
2. Does the test waveform comply with monophasic truncated exponential wave requirements? Yes, the measured peak voltage of 1.53 kV, duration of 18 ms, and decay characteristic >50% of peak value fully match the standard waveform.
3. Does the system support biphasic waveforms? The current version focuses on monophasic truncated exponential waveforms. Biphasic waveform support is available upon request for customization.
4. How is testing safety ensured? The system incorporates multiple protection mechanisms, including high-voltage isolation, emergency stop button, and automatic discharge function.
5. How to verify device recovery after testing? After testing, the device under test can be reprogrammed using a programmer to check if normal function is restored—this is a key step in standard evaluation.
6. Does the system require periodic calibration? Annual calibration by a professional organization is recommended to maintain waveform accuracy.
