IEC 60601-2-31 Defibrillation Pulse Tester

The IEC 60601-2-31 Defibrillation Pulse Tester is a professional laboratory instrument used to evaluate the defibrillation protection performance of external cardiac pacemakers with internal power source. During clinical use, an external cardiac pacemaker may be exposed to defibrillation pulses. Therefore, the device must be tested to confirm that it can continue to meet basic safety and essential performance requirements after the specified pulse exposure.

The KP-900S uses a controlled RCL discharge circuit to generate defibrillation pulse waveforms and applies them to the equipment under test through a built-in three-chamber external pacemaker test network. This integrated design helps laboratories perform repeatable defibrillation protection testing according to IEC 60601-2-31 and YY 9706.231 requirements.

This product is a laboratory testing instrument. It is not a clinical defibrillator, not a cardiac pacemaker and not intended for patient treatment.

Applicable Standards and Test Method

The KP-900S is designed for IEC 60601-2-31:2020 and YY 9706.231-2023 related defibrillation protection testing of external cardiac pacemakers with internal power source. It supports standard pulse generation, polarity sequence testing and connection through the built-in three-chamber test network.

During testing, the external cardiac pacemaker is connected to the test network according to the laboratory procedure. The operator sets the required voltage, pulse polarity and pulse count through the touchscreen interface. The instrument then charges the internal storage capacitor and discharges through the RCL circuit to generate the required defibrillation pulse waveform.

The final sample connection, test clause, acceptance criteria and post-test functional evaluation should follow the applicable standard version, product risk analysis and laboratory quality procedure.

Technical Specifications

Detailed Pulse and Waveform Test Parameters

The following pulse output and waveform parameters are based on the KP-900S specification for IEC 60601-2-31 and YY 9706.231 defibrillation protection testing. Final test setup, polarity sequence, sample connection method and verification documentation can be reviewed according to the customer’s external cardiac pacemaker type, applicable standard version and laboratory procedure.

Standard and Test Scope

Pulse Output and Waveform Parameters

Instrument Configuration

Technical Note : For IEC 60601-2-31 compliance testing, the RCL discharge circuit, pulse voltage, energy range, waveform timing, polarity sequence and built-in three-chamber test network should remain aligned with the applicable standard requirements. Appearance, panel marking, interface labeling, logo position or language display can be discussed according to customer laboratory needs, but such customization should not affect the standard-required pulse waveform, internal circuit parameters, safety protection design or verification performance.

Before formal testing, users should confirm the applicable standard version, test clause, sample connection method and waveform verification requirements. For laboratory quality control, regular verification of output voltage, pulse polarity, waveform timing and test network integrity is recommended.

Testing Principle

External cardiac pacemakers with internal power source may be exposed to defibrillation pulses during patient treatment. The IEC 60601-2-31 Defibrillation Pulse Tester uses an RCL discharge circuit to generate a controlled defibrillation pulse with defined voltage, energy and waveform timing.

The pulse is applied to the pacemaker under test through the built-in three-chamber external pacemaker test network. The test evaluates whether the pacemaker can maintain basic safety and essential performance after exposure to the required pulse sequence. By controlling pulse voltage, polarity, interval and test count, the KP-900S provides a repeatable method for defibrillation protection verification in medical device laboratories.

Built-in Test Network and Output Interface

The KP-900S integrates a built-in three-chamber external pacemaker test network for IEC 60601-2-31 related defibrillation protection testing. This helps reduce the need for additional external test network assembly and supports a more consistent laboratory setup.

The front panel includes the touchscreen interface, power switch, pulse output terminals, ME test network interfaces and high-voltage status indication. Operators can set test voltage, pulse polarity and pulse count, then monitor charging, discharging, pulse output and instrument status during the test process.

Key Features

The IEC 60601-2-31 Defibrillation Pulse Tester provides a dedicated RCL discharge circuit for external cardiac pacemaker defibrillation protection testing. It supports 900 V pulse output, 50 J to 55 J energy range, Tw50 waveform timing and selectable positive or negative pulse polarity.

The instrument integrates touchscreen operation, built-in three-chamber test network, pulse count setting, test mode, calibration mode and high-voltage output indication in one benchtop system. Its structure is suitable for medical device manufacturers, testing laboratories and quality inspection organizations that require repeatable IEC 60601-2-31 pulse testing.

Applications and Laboratory Use

The KP-900S is suitable for external cardiac pacemaker manufacturers, medical device testing laboratories, quality inspection institutions, R&D organizations and regulatory compliance teams.

Typical applications include defibrillation protection type testing, product development verification, sample comparison testing, production quality control, incoming inspection support and compliance preparation for external cardiac pacemakers with internal power source.

This product should not be used for defibrillation electrode performance testing. For disposable defibrillation electrodes or multifunction electrode performance evaluation, a different IEC 60601-2-4 related test system should be used.

Operation and Safety Notes

Before testing, users should confirm the applicable IEC 60601-2-31 or YY 9706.231 version, test clause, sample connection method, test voltage and pulse sequence requirement. The external cardiac pacemaker should be connected to the built-in test network according to the laboratory procedure before the pulse test starts.

Because the instrument generates high-voltage defibrillation pulses, it should only be operated by trained personnel in a controlled laboratory environment. Operators should confirm grounding, cable connection, output terminal condition, warning indicators and emergency safety procedures before testing.

The instrument is intended for laboratory testing only. It must not be connected to a patient or used for clinical defibrillation, pacing or treatment.