|
Technical Specification (Compliant with ISO 27186:2020 Annex E)
The KP-1240S High Voltage Current Carrying Test System is a specialized test instrument designed to generate high-intensity pulse currents simulating defibrillation shocks for active implantable medical devices. This system is designed and manufactured in accordance with the requirements of Annex E (normative) in ISO 27186:2020 — Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensions and test requirements, serving as an updated supplement to the original Annex E in YY/T 0972-2016.
The primary purpose of this test system is to evaluate the four-pole connector system (IS-4/DF-4) in implantable cardiac rhythm management devices (such as pacemakers and ICDs) for permanent damage when subjected to external high-voltage defibrillation pulse currents, and to verify whether the original settings can be restored through reprogramming, thereby assessing the safety and reprogrammability of the connector.
| Parameter | Specification |
|---|---|
| Voltage Range | 0 - 2 kV (adjustable, with peak up to 1.53 kV as measured) |
| Current Peak | ≥50 A (under standard 100 Ω load, simulating defibrillation conditions) |
| Pulse Duration | 10 - 20 ms (adjustable; default 18 ms truncated exponential decay) |
| Waveform Rise Time | < 10 µs (fast rise to simulate real defibrillator shocks) |
| Energy Delivery | Up to approximately 200 J (calculated based on waveform and load) |
| Repetition Rate | 1 - 10 pulses per minute (manual or automated sequencing) |
| Load Simulation | Built-in resistive load (50 - 100 Ω) to mimic patient impedance during external defibrillation |
| Polarity Switching | Automatic or manual selection of positive/negative polarity |
| Measurement Accuracy | Voltage ±1%, Current ±2%, Time ±0.5% |
| Output Connections | High-voltage safety connectors compatible with IS-4/DF-4 test fixtures |
This system is designed with ISO 27186:2020 Annex E as the core reference, which specifies the high-voltage pulse withstand test method for four-pole connector systems, including simulation of high-energy pulses applied to the connector by an external defibrillator.
Compared to YY/T 0972-2016, ISO 27186:2020 updates the dimensions, electrical, and functional requirements for four-pole connectors (IS-4 low-voltage type and DF-4 high-voltage type) and strengthens functional compatibility testing under high-voltage shocks.
The test pulse is designed to ensure no permanent damage to the connector after high-voltage impact and to support reprogramming recovery of the pulse generator, verifying overall system safety and reliability.
In today's increasingly globalized medical device industry, test equipment compliant with the latest ISO 27186:2020 standard has become essential for connector testing in implantable cardiac devices. The KP-1240S not only retains compatibility with YY/T 0972-2016 but has been fully upgraded to the 2020 international standard, helping companies efficiently meet CE marking, FDA approval, and other global registration requirements.
If you are conducting defibrillation withstand testing for implantable pacemaker or ICD connectors, the KP-1240S is your reliable choice, ensuring product safety and market competitiveness.
Contact us for more technical details or a quotation!
|
|
Technical Specification (Compliant with ISO 27186:2020 Annex E)
The KP-1240S High Voltage Current Carrying Test System is a specialized test instrument designed to generate high-intensity pulse currents simulating defibrillation shocks for active implantable medical devices. This system is designed and manufactured in accordance with the requirements of Annex E (normative) in ISO 27186:2020 — Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensions and test requirements, serving as an updated supplement to the original Annex E in YY/T 0972-2016.
The primary purpose of this test system is to evaluate the four-pole connector system (IS-4/DF-4) in implantable cardiac rhythm management devices (such as pacemakers and ICDs) for permanent damage when subjected to external high-voltage defibrillation pulse currents, and to verify whether the original settings can be restored through reprogramming, thereby assessing the safety and reprogrammability of the connector.
| Parameter | Specification |
|---|---|
| Voltage Range | 0 - 2 kV (adjustable, with peak up to 1.53 kV as measured) |
| Current Peak | ≥50 A (under standard 100 Ω load, simulating defibrillation conditions) |
| Pulse Duration | 10 - 20 ms (adjustable; default 18 ms truncated exponential decay) |
| Waveform Rise Time | < 10 µs (fast rise to simulate real defibrillator shocks) |
| Energy Delivery | Up to approximately 200 J (calculated based on waveform and load) |
| Repetition Rate | 1 - 10 pulses per minute (manual or automated sequencing) |
| Load Simulation | Built-in resistive load (50 - 100 Ω) to mimic patient impedance during external defibrillation |
| Polarity Switching | Automatic or manual selection of positive/negative polarity |
| Measurement Accuracy | Voltage ±1%, Current ±2%, Time ±0.5% |
| Output Connections | High-voltage safety connectors compatible with IS-4/DF-4 test fixtures |
This system is designed with ISO 27186:2020 Annex E as the core reference, which specifies the high-voltage pulse withstand test method for four-pole connector systems, including simulation of high-energy pulses applied to the connector by an external defibrillator.
Compared to YY/T 0972-2016, ISO 27186:2020 updates the dimensions, electrical, and functional requirements for four-pole connectors (IS-4 low-voltage type and DF-4 high-voltage type) and strengthens functional compatibility testing under high-voltage shocks.
The test pulse is designed to ensure no permanent damage to the connector after high-voltage impact and to support reprogramming recovery of the pulse generator, verifying overall system safety and reliability.
In today's increasingly globalized medical device industry, test equipment compliant with the latest ISO 27186:2020 standard has become essential for connector testing in implantable cardiac devices. The KP-1240S not only retains compatibility with YY/T 0972-2016 but has been fully upgraded to the 2020 international standard, helping companies efficiently meet CE marking, FDA approval, and other global registration requirements.
If you are conducting defibrillation withstand testing for implantable pacemaker or ICD connectors, the KP-1240S is your reliable choice, ensuring product safety and market competitiveness.
Contact us for more technical details or a quotation!
Address
RM C, 13/F, HARVARD COMMERCIAL BUILDING, 105-111 THOMSON ROAD, WAN CHAI, HK
Tel
86-769- 81627526
