IEC 60601-2-31 Defibrillation Pulse Tester for External Cardiac Pacemakers

IEC 60601-2-31 Defibrillation Protection Test Pulse Generator

The KingPo KP-900S is a dedicated defibrillation protection test pulse generator for evaluating external cardiac pacemakers with an internal power source. It reproduces the specified defibrillation-related electrical stress condition so laboratories and manufacturers can verify whether the pacemaker remains safe and functional after pulse exposure.

The system generates the required pulse through an RCL discharge circuit comprising a 120 μF ±5% capacitor, 25 μH ±5% inductance and a combined resistance condition of R_L + R = 1 Ω ±5%. It provides a maximum pulse voltage of 900 V, pulse energy from 50 J to 55 J and a Tw50 waveform timing range of 4.05 ms to 4.6 ms.

Unlike a general impulse generator or defibrillator analyzer, the KP-900S is configured specifically for IEC 60601-2-31 external cardiac pacemaker defibrillation protection testing. Its programmable pulse control, selectable first-pulse polarity and built-in pacemaker test network support controlled and repeatable laboratory verification.

Application and Output Summary

Technical Specifications

The following specifications define the standard KP-900S configuration for IEC 60601-2-31 and YY 9706.231 external cardiac pacemaker defibrillation protection testing.

Why Defibrillation Protection Testing Is Required

During clinical use, an external cardiac pacemaker may be exposed to defibrillation pulse stress through the patient connection path. The test determines whether the pacemaker can withstand the specified electrical stress without permanent damage.

After the required pulse sequence has been completed, the equipment is evaluated according to the applicable procedure to confirm that its basic safety and essential performance remain acceptable.

This is not simply a high-voltage output test. Pulse voltage, stored energy, RCL circuit parameters, waveform duration, polarity sequence, DUT connection and the pacemaker test network all affect the complete test condition.

RCL Defibrillation Pulse Generation

The KP-900S charges its energy-storage capacitor to the set voltage and then discharges it through the RCL circuit and pacemaker test network. The capacitance, inductance and resistance condition shape the pulse and establish the required voltage, energy and waveform timing.

Tw50 represents the interval during which the pulse voltage remains above 50% of its maximum value. The specified KP-900S Tw50 range is 4.05 ms to 4.6 ms.

Pulse Polarity and Timing Control

The operator can select the polarity of the first pulse group. The system applies three pulses of the selected polarity with an interval of 20 s to 25 s between each pulse.

After a pause of at least 60 s, the system applies three pulses of the opposite polarity. Programmable timing and pulse counting help reduce manual timing errors during repeated testing.

Built-in Pacemaker Test Network

The KP-900S includes a built-in three-chamber external cardiac pacemaker test network. The integrated network supports the required test arrangement and reduces the need to assemble a separate external network box for routine laboratory testing.

The instrument provides OutA and OutB pulse output terminals together with an ME interface and Out1–Out5 test network connections. DUT wiring should follow the instruction manual, applicable clause and laboratory procedure.

Test mode is used for normal pulse generation. Calibration mode allows output voltage checking, verification and compensation according to the laboratory’s calibration procedure.

Waveform, Voltage and Energy Verification

Available product records include measured pulse waveforms and an example measured energy value of approximately 52 J, providing a reference within the specified 50 J to 55 J output range.

For formal laboratory use, output voltage, pulse energy, Tw50 timing, polarity and test network integrity should be verified according to the laboratory’s quality system. Calibration documentation, waveform screenshots and inspection records can be confirmed according to project requirements.

Product Scope and Test Object

The KP-900S should be selected when the device under test is an external cardiac pacemaker with an internal power source and the required evaluation is defibrillation protection testing under IEC 60601-2-31 or YY 9706.231.

It is a laboratory test instrument for trained personnel. It is not a clinical defibrillator, cardiac pacemaker, patient-treatment device or general-purpose defibrillator analyzer, and it must not be connected to a patient.

The KP-900S is not intended for disposable defibrillation electrode pad testing. When the test object is a defibrillation electrode or multifunction electrode, use a dedicated IEC 60601-2-4 defibrillation electrode performance tester. 

Typical Applications

Laboratory Safety and Configuration

The KP-900S generates high-voltage, high-energy pulses and should be operated only by trained laboratory personnel following the instruction manual, laboratory safety procedures and applicable standard requirements.

Before formal testing, users should confirm the applicable standard version, test clause, DUT connection method, pulse polarity sequence, waveform verification procedure and documentation requirements.

Appearance, panel markings, interface labels, display language and logo position may be discussed according to project requirements. Such customization must not change the RCL circuit parameters, pulse waveform, energy output, safety protection or verification performance.