KP-1230S Dielectric Strength Tester | ISO 27186:2020 Quadripolar Connector Defibrillation

Dielectric Strength Tester | ISO 27186:2020 Quadripolar Connector Defibrillation Waveform Tester

The KingPo KP-1230S Dielectric Strength Tester is a professional high-voltage test instrument designed to generate monophasic truncated exponential defibrillation waveforms for evaluating the dielectric strength and reprogramming recovery capability of quadripolar connector systems in active implantable cardiac rhythm management devices, in full accordance with ISO 27186:2020 Annex C and YY/T 0972-2016 Appendix C.

Technical Parameters

Waveform Performance Parameters

The KP-1230S Dielectric Strength Tester incorporates a dedicated high-voltage pulse generation circuit engineered to deliver a precise monophasic truncated exponential waveform with a controlled rise time of 1.4 μs and voltage slew rate of 1.08 kV/μs. The system features advanced high-voltage isolation transformers, programmable energy control, and real-time waveform capture using high-bandwidth monitoring circuits to guarantee output accuracy and long-term repeatability.

Safety-critical components include automatic high-voltage discharge circuits, emergency stop interlocks, and multiple redundant protection mechanisms to safeguard both the operator and the device under test. The compact desktop enclosure is constructed with shielded enclosures and high-reliability components, making it ideally suited for integration into medical device R&D laboratories and certification test benches while fully complying with ISO 27186:2020 Annex C and YY/T 0972-2016 Appendix C requirements.

Testing Principle

The KP-1230S applies a standardized monophasic truncated exponential defibrillation waveform (peak voltage 1.53 kV, pulse duration 18 ms, with >50% voltage decay) directly across the quadripolar connector of the implantable cardiac rhythm management device under test. Following the high-voltage pulse exposure, the device is evaluated for any permanent dielectric breakdown or functional degradation, with subsequent reprogramming performed to verify full restoration of normal operating parameters as required by the standard.

Common Error Mitigation

To ensure maximum repeatability and measurement integrity, always verify the actual output waveform parameters (rise time, peak voltage, and decay characteristic) using a calibrated high-voltage oscilloscope prior to each test sequence. Confirm secure connection of the quadripolar test fixture and correct load impedance matching the standard. Perform immediate post-pulse reprogramming verification using the manufacturer’s programmer to accurately assess device recovery. Scheduled annual calibration of the high-voltage generation circuit is strongly recommended to maintain traceability and waveform accuracy.

Primary Use Cases & Business Value

The KP-1230S Dielectric Strength Tester is the dedicated high-voltage test solution used by medical device manufacturers and independent certification laboratories to verify the dielectric strength and defibrillation resistance of quadripolar connector systems in active implantable cardiac devices. It provides repeatable, standardized evaluation of connector integrity under simulated clinical defibrillation conditions, thereby ensuring long-term device reliability, patient safety, and full regulatory compliance with international safety standards.

Industrial Applications & Lab Scenarios

• Implantable Medical Device Manufacturers — Dielectric strength and defibrillation waveform endurance testing of quadripolar connectors in pacemakers, ICDs and CRT devices during product development and validation.
• Third-Party Certification Laboratories — Traceable compliance verification according to ISO 27186:2020 Annex C and YY/T 0972-2016 Appendix C.
• R&D Departments — Development and optimization of next-generation connector systems and lead designs to improve high-voltage tolerance and reprogramming recovery performance.
• Quality Control Teams — End-of-line batch verification and production sampling to ensure consistent dielectric strength of implantable leads and pulse generators before shipment.
• Regulatory Compliance Teams — Generation of technical documentation and test reports demonstrating connector safety and functional recovery for regulatory submissions and market approval.

Strategic Procurement Advantages & Global Support

• High-Efficiency Testing: Precise monophasic truncated exponential waveform generation with automated safety features for fast, repeatable testing.
• Certified Manufacturing: ISO 9001/14001/45001 and CE certified production with ISO 17025 traceable calibration ensures laboratory-grade reliability.
• Reliability & Support: Each unit undergoes rigorous factory calibration in our Dongguan facility and is backed by a full one-year warranty, on-site installation guidance, and lifetime technical engineering support.