ISO 14117 High-Frequency Surgical Exposure Test Equipment – 500 kHz Generator
The KINGPO KP-H500 High-Frequency Surgical Exposure Test Generator produces controlled 500 kHz electrical test signals for evaluating the response of active implantable medical devices to high-frequency surgical exposure. Depending on the selected test network and test program, it supports applications involving cardiac pacemakers, ICDs, CRT devices and implantable hearing systems under ISO 14117, ISO 14708 and related Chinese medical-device standards.
- Primary Test Signal: 500 kHz sine wave
- Frequency Accuracy: ≤ ±0.1%
- Maximum Open-Circuit Output: ≥36 Vpp
- Continuous Output Duration: ≥30 s
- Test Modes: Continuous, burst and programmable timing modes
- Typical DUTs: Implantable cardiac pacemakers, CRT-P, ICD, CRT-D and applicable cochlear implant systems
- Control: Touchscreen and PC control
- Optional Test Networks: KP-H500-1, KP-H500-2 and KP-H500-3
- Typical Standards: ISO 14117, ISO 14708-6, ISO 14708-7, YY/T 1874, YY 0989.6 and YY 0989.7
- Configuration: Test network and applicable standard edition should be confirmed before quotation
ISO 14117 Clause 6.1 High-Frequency Surgical Exposure Test Generator
Product Overview
High-frequency surgical equipment can introduce high-frequency electrical currents into a patient during treatment. For an active implantable medical device, this represents a potential electromagnetic disturbance that must be considered during safety and EMC evaluation.
The KP-H500 is designed to reproduce the specified electrical exposure in a controlled laboratory environment. Instead of performing a surgical procedure or testing an electrosurgical generator itself, the system generates a defined 500 kHz sinusoidal test signal and applies it to the device under test through a standard-specific resistance or interface network.
The purpose of the test is to determine whether exposure to the specified high-frequency signal causes unacceptable permanent changes in the implanted device and, where required by the applicable test method, whether the device can return to its intended operating condition after the exposure and subsequent programming or reactivation.
This makes the KP-H500 particularly relevant to manufacturers and laboratories working with active implantable cardiovascular devices and selected implantable hearing systems.
Technical Specifications
| Item | Specification |
|---|---|
| Signal waveform | Sine wave |
| Signal frequency | 500 kHz |
| Frequency accuracy | ≤ ±0.1% |
| Maximum open-circuit voltage | Vpp ≥36 V |
| Continuous output duration | ≥30 s |
| Test modes | Continuous mode, burst mode, programmable mode |
| Programmable timing | Burst duration, interval and total duration can be configured |
| Number of test cycles | 1–999 |
| Control | Touchscreen and PC control |
| Power supply | AC 220 V ±10%, 50/60 Hz |
| Dimensions | 320 × 260 × 150 mm |
| Weight | Approx. 2 kg |
| Test networks | Optional; selected according to applicable device and standard |
What Does the KP-H500 Actually Test?
The KP-H500 does not measure the output performance of an electrosurgical unit.
Instead, it is used on the other side of the safety problem: the active implantable medical device.
During a high-frequency surgical procedure, electrical energy from surgical equipment can create a disturbance that may couple into an implanted electronic system. The applicable standards therefore include tests intended to determine whether the implanted device can tolerate specified high-frequency surgical exposure without unacceptable permanent effects.
Typical devices considered in relevant test programs include:
ISO 14117:2019 specifically defines EMC test methodologies for implantable cardiac pacemakers, implantable cardioverter-defibrillators and cardiac resynchronization devices.
ISO 14708-7:2019 covers active implantable devices used for electrical stimulation of the auditory pathways, including cochlear and auditory brainstem implant systems.
Test Principle
The test concept can be understood as a controlled electrical exposure test.
Connect the Device Under Test
The active implantable medical device is connected to the appropriate test network according to the applicable standard, device type and test clause.
Different resistor or interface arrangements are required for different implant systems. The external network is therefore an important part of the complete test configuration.
Generate the 500 kHz Test Signal
The KP-H500 generates a controlled sinusoidal signal at 500 kHz.
The generator uses digitally controlled frequency synthesis to establish the high-frequency waveform and allows the required test duration and exposure sequence to be programmed.
Apply the Required Exposure
Depending on the selected test program, the DUT may be exposed to:
- A continuous high-frequency signal; or
- Repeated high-frequency signal bursts separated by recovery periods.
Evaluate the DUT After Exposure
Following the specified test sequence, the laboratory evaluates the device according to the performance criteria of the applicable standard.
Depending on the device and test method, this can include checking whether:
- The device has suffered permanent functional degradation
- Programmed characteristics have changed
- The device can be reactivated or reprogrammed as required
- Its post-test operation remains consistent with the applicable acceptance criteria
The KP-H500 provides the electrical exposure required for the test; determination of conformity remains dependent on the applicable standard, DUT specification and laboratory evaluation procedure.
Supported Test Modes
Cardiac Device High-Frequency Exposure Mode
For the cardiac-device configuration described in the supplied documentation:
| Frequency | 500 kHz |
| Waveform | Continuous sine wave |
| Open-circuit signal voltage | 36 Vpp |
| Exposure duration | 30 s continuous |
This configuration is intended for testing associated with cardiac pacemakers, CRT-P devices and, with the appropriate DUT loading arrangement, ICD and CRT-D devices.
The supplied specification associates this mode with ISO 14117 / YY/T 1874 applications.
Cochlear Implant Test Mode
The supplied KP-H500 specification also provides a test program intended for applicable ISO 14708-7 / YY 0989.7 applications:
| Frequency | 500 kHz |
| Waveform | Sine wave |
| Open-circuit voltage | 20 Vpp |
| Burst duration | 1 s |
| Recovery interval | 5 s |
| Number of bursts | 10 |
The correct network, standard edition and applicable clause should be confirmed for the specific implant system before quotation or testing.
Programmable Mode
For development, verification or project-specific test procedures, the KP-H500 also provides programmable timing control.
Depending on the selected configuration, users can define:
- Signal burst duration
- Interval between bursts
- Total test duration
- Number of test cycles
This allows the same generator platform to be configured around different defined test sequences without changing the basic 500 kHz signal-generation function.
Test Network Configuration
A correct test network is essential because different types of active implantable medical devices use different interfaces, electrodes and electrical loading conditions.
The KP-H500 can therefore be supplied with different external test network boxes.
| Network | Intended Application |
|---|---|
| KP-H500-1 | Test network for applicable YY 0989.7 / ISO 14708-7 implant hearing-system test arrangements |
| KP-H500-2 | Test network for YY/T 1874 / ISO 14117 cardiac implant EMC applications |
| KP-H500-3 | Test network for applicable YY 0989.6 / ISO 14708-6 applications |
Applicable Standards and Edition Considerations
The KP-H500 is intended to support test configurations associated with the following standards, depending on the selected network and test program:
ISO 14117:2019
Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
ISO 14117 includes test methodologies for evaluating the electromagnetic compatibility of active implantable cardiovascular devices and includes requirements addressing therapeutic electromagnetic environments. The 2019 edition remains current.
The KP-H500 specifically addresses the high-frequency surgical exposure application rather than representing a complete ISO 14117 EMC test system.
ISO 14708-6:2019
Applicable to implantable cardioverter-defibrillators, CRT-D devices and active implantable device functions intended to treat tachyarrhythmia. The 2019 edition remains current.
ISO 14708-7:2019
Applicable to active implantable medical devices intended to treat hearing impairment through electrical stimulation of the auditory pathways, including cochlear and auditory brainstem implant systems. The 2019 edition was reconfirmed in 2026.
Typical Laboratory Applications
The KP-H500 is suited to laboratory environments where repeatable high-frequency surgical exposure testing is required, including:
The programmable test modes are also useful during product development when engineers need to repeat a defined exposure sequence while investigating device behaviour before formal compliance testing.
Standards Compliance & Regulatory Considerations
- The KP-H500 supports high-frequency surgical exposure testing for active implantable medical devices under applicable standards including ISO 14117, ISO 14708-6, ISO 14708-7, YY/T 1874, YY 0989.6 and YY 0989.7, depending on the selected test mode and test network. The applicable standard edition, clause and DUT type should be confirmed before quotation.
- Documentation can be configured according to project requirements, including test configuration information, operating instructions, output verification, timing verification and requested calibration points. Third-party or accredited calibration requirements should be specified before order confirmation.
High-Frequency Surgical Exposure Test Equipment
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