KP3301 defibrillation-proof and energy reduction tester left front view
Front view of KP3301 IEC 60601-1 Defibrillation-Proof and Energy Reduction Tester
KP3301 defibrillation tester with automatic lead converter box
Automatic defibrillation lead converter box for KP3301 ECG defibrillation testing
KP3301 defibrillation-proof and energy reduction tester left front view
Front view of KP3301 IEC 60601-1 Defibrillation-Proof and Energy Reduction Tester
KP3301 defibrillation tester with automatic lead converter box
Automatic defibrillation lead converter box for KP3301 ECG defibrillation testing

IEC 60601-1 Defibrillation-Proof and Energy Reduction Tester

The KingPo KP3301 is an IEC 60601-1 defibrillation-proof and energy reduction tester for evaluating protection against the effects of defibrillation in electrocardiographs, ECG monitors, multifunction patient monitors and other compatible patient-connected medical electrical equipment.

It supports positive and negative charging voltages up to ±5.5 kV, common-mode and differential-mode testing, energy-reduction measurement, automatic Y1-Y2 voltage calculation and optional manual or automatic ECG lead switching.

  • Applicable Standard Family: IEC 60601-1, relevant IEC 60601 particular standards, and applicable IEC 80601 particular standards for compatible patient-connected medical equipment, including multifunction patient monitors.
  • Product Model: KP3301
  • Charging Voltage: 0 to ±5.5 kV, accuracy ±1%
  • Main Capacitance: 32 μF ±5%, rated 8 kV
  • Selectable Inductance: 500 μH and 25 mH, tolerance ±5%
  • Test Arrangements: Common-mode and differential-mode testing
  • Energy Measurement: Automatic calculation with 1 J display resolution
  • Lead Switching: Manual adapter or optional automatic defibrillation lead converter box
  • Typical DUT: Electrocardiographs, ECG monitors, multifunction patient monitors and related patient-connected modules
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Product Overview

Product Overview

Integrated Defibrillation-Related Testing for Patient-Connected Medical Equipment

Electrocardiographs, ECG monitors, multifunction patient monitors and other equipment connected to a patient may remain connected when a clinical defibrillation pulse is applied. Their patient-connected circuits may therefore require evaluation for protection against the effects of defibrillation, energy transmission and post-exposure electrical or functional performance.

The KP3301 integrates the high-voltage charging source, 32 μF main capacitor, selectable resistance and inductance networks, positive and negative polarity control, energy calculation, Y1-Y2 voltage calculation and internal physiological signal simulation into one test platform.

This integrated arrangement reduces repeated assembly of external test circuits and helps medical device manufacturers and laboratories establish a more controlled and repeatable test setup.

Main Instrument and Supporting Accessories

The primary product is the KP3301 main instrument. Depending on the DUT lead arrangement and laboratory workflow, it can be used with:

  • A manual defibrillation adapter for direct lead-by-lead connection
  • An optional automatic defibrillation lead converter box for programmed ECG lead switching
  • A DB9 serial communication cable used with the automatic converter configuration
  • Output leads, Y1-Y2 test leads, grounding wires and connection accessories
Accessory clarification: The automatic converter box is an auxiliary switching device. It does not generate the high-voltage test pulse and does not replace the KP3301 main instrument.
Product distinction: The KP3301 should be distinguished from a clinical defibrillator analyzer. A defibrillator analyzer evaluates the energy and waveform delivered by a defibrillator, whereas the KP3301 generates controlled electrical test conditions for evaluating patient-connected medical equipment.

Key Information

What Buyers Need to Confirm First

Applicable Standard Family:
IEC 60601-1 and selected particular standards for compatible patient-connected medical equipment
Product Model:
KP3301
Primary Test Purpose:
Protection against the effects of defibrillation, energy reduction and Y1-Y2 residual or hazardous voltage evaluation
Test Arrangements:
Common-mode and differential-mode testing
Typical DUT:
Electrocardiographs, ECG monitors, multifunction patient monitors, patient cables and compatible physiological monitoring modules
Configuration Note:
Confirm the applicable standard edition, test clause, DUT applied-part configuration, number of patient leads, required test mode and lead-switching method before ordering.

Instrument Data

KP3301 Technical Specifications

Instrument Parameter Specification
Charging Voltage 0 ~ ±5.5 kV ±1%
Main Capacitor 32 μF ±5% (imported solid capacitor, 8 kV rating)
Inductance 500 μH and 25 mH ±5%
Internal Resistance 10 Ω and 11 Ω (automatically switch or set per standard)
Main Resistor (non-inductive) 100 Ω, 50 Ω, 400 Ω ±1%
Internal Signal Sine wave: 10 Hz, 0.5~10 mV (default 5 mV) Respiration rate: 5~60 rpm (default 27 rpm)
Voltage Control Digital settings
Polarity Control Positive/negative, digital settings
Control & Display 7-inch LCD touchscreen
Voltage Resolution & Accuracy 1 V, ±1%
Energy Test Mode Operating with 25 mH inductance (meets energy reduction test requirements) Display resolution: 1 Joule
Energy Test Reference Values No-load: R=10 Ω → theoretical 364 J ±1% R=11 Ω → theoretical 360 J ±1%
Y1-Y2 (Residual/Hazardous Voltage) Automatically calculated (avoids oscilloscope interference errors)
Model Differences KP3301: Manual defibrillator lead switching KP3301B: Includes automatic defibrillator lead converter box for fully automated ECG lead testing

Test Functions

What the KP3301 Evaluates

Protection Against the Effects of Defibrillation

The KP3301 supports common-mode and differential-mode test arrangements for ECG-related equipment and other compatible patient-connected circuits. A controlled positive or negative high-voltage condition is applied to the selected DUT inputs through the required resistance and inductance network.

Depending on the applicable standard and equipment type, the evaluation may include electrical protection of patient-connected inputs, equipment recovery after exposure, continued operation of essential functions, residual or hazardous voltage, energy transmitted through the DUT and the condition of the applied-part circuit.

Energy Reduction Measurement

The KP3301 provides an energy reduction test mode using the 25 mH inductance configuration. The result is calculated automatically and displayed with a resolution of 1 J.

The theoretical no-load reference values are approximately 364 J with the 10 Ω configuration and approximately 360 J with the 11 Ω configuration. These values describe the specified no-load circuit conditions and should not be treated as universal pass/fail limits.

Y1-Y2 Residual or Hazardous Voltage

The KP3301 automatically calculates the Y1-Y2 residual or hazardous voltage result for the supported test arrangement. External waveform or voltage verification may still be required where specified by the applicable standard, laboratory procedure or quality system.

ECG and Respiration Signal Simulation

The built-in 10 Hz sine-wave signal, adjustable ECG amplitude and adjustable respiration-rate signal help the operator observe the response or recovery of compatible ECG and respiration channels without requiring a separate basic signal source for every setup.

How the Test Is Performed

Test Principle

The KP3301 simulates a controlled defibrillation-related electrical condition and applies it to the selected patient-connected inputs of the DUT.

  1. Identify the DUT, applied part and applicable standard clause.
  2. Select the common-mode or differential-mode test arrangement.
  3. Set the required positive or negative charging voltage.
  4. Select the required resistance and inductance network.
  5. Connect the DUT using the manual adapter or automatic lead converter box.
  6. Apply the required pulse or test sequence.
  7. Record the energy reduction or Y1-Y2 result where applicable.
  8. Check the electrical and functional condition of the DUT after exposure.
  9. Compare the results with the acceptance criteria of the applicable standard.
The KP3301 provides the electrical test source, test-network selection and supported measurement functions. Final compliance remains dependent on the complete test arrangement, the applicable standard edition, the DUT connection and the approved laboratory procedure.

Test Arrangements

Common-Mode and Differential-Mode Testing

Common-Mode Test

In a common-mode arrangement, the applicable patient connections are grouped and exposed to the defibrillation-related test condition relative to another reference point in the circuit. This helps evaluate how the patient-connected input system responds when multiple leads are subjected to a common electrical stress.

Differential-Mode Test

In a differential-mode arrangement, the test voltage is applied between selected patient connections or lead groups. This helps evaluate the protection provided between individual applied-part inputs and the behavior of the corresponding input circuitry.

IEC 60601-2-25 and IEC 60601-2-27 include test arrangements for protection against the effects of defibrillation in electrocardiographs and ECG monitoring equipment. The exact circuit, lead grouping and acceptance criteria must be confirmed from the applicable edition and clause.

Supporting Accessories

Manual and Automatic Lead-Switching Options

The KP3301 can be configured according to the number of ECG leads, test frequency and level of automation required by the laboratory.

Manual Defibrillation Adapter

The manual defibrillation adapter allows the operator to connect and switch the required ECG leads manually. After one lead or lead combination is tested, the operator changes the connection before starting the next test.

This configuration is suitable for occasional testing, customized lead arrangements, engineering investigation, DUTs with non-standard connectors and lower-volume laboratory work.

Automatic Defibrillation Lead Converter Box

The optional automatic defibrillation lead converter box switches selected ECG leads according to the programmed test process. It is intended for repeated multi-lead ECG testing where the same pulse sequence must be applied to several lead combinations.

  • Automatic switching of selected ECG leads
  • Reduced repeated manual reconnection
  • More consistent lead selection
  • Improved repeatability between test cycles
  • Reduced operator intervention
The converter box is an auxiliary switching device. High-voltage pulse generation, energy calculation and Y1-Y2 calculation remain functions of the KP3301 main instrument.

DB9 Serial Communication Cable

The DB9 serial communication cable is used with the automatic converter configuration to connect the KP3301 to the automatic lead converter box. The DUT connector, number of leads, lead-switching sequence and converter interface should be confirmed before quotation.

Standards Review

Applicable Standards and Equipment Scope

The original KingPo document references IEC 60601-1 and several particular standards related to patient-connected medical equipment. The correct test circuit must be selected according to the DUT, standard edition and applicable clause.

IEC 60601-1 Edition 3.2

IEC 60601-1 Edition 3.2 consists of IEC 60601-1:2005, Amendment 1:2012 and Amendment 2:2020. It contains the general requirements for basic safety and essential performance of medical electrical equipment. Where a particular standard exists, the general standard is not normally used alone.

IEC 60601-2-25:2011

IEC 60601-2-25 applies to the basic safety and essential performance of diagnostic electrocardiographs. The DUT lead configuration and applicable common-mode or differential-mode test circuit should be confirmed before testing.

IEC 60601-2-27:2011

IEC 60601-2-27 applies to electrocardiographic monitoring equipment used in hospitals and certain environments outside hospitals, including ambulances and air transport.

IEC 60601-2-34:2024

IEC 60601-2-34:2024 is the current IEC publication for the basic safety and essential performance of invasive blood pressure monitoring equipment. Applicability of the KP3301 circuit must be reviewed against the specific DUT input and clause.

IEC 80601-2-49:2018+A1:2024

IEC 80601-2-49 applies to multifunction patient monitors containing two or more physiological monitoring units connected to one patient. Individual ECG, invasive-pressure and other physiological units may also be subject to their respective particular standards.

Other Referenced Standards

The original KingPo document also lists IEC 60601-2-26, IEC 60601-2-30, GB 9706 series requirements, YY 0828, EC13 and EC53.

  • IEC 60601-2-26 has been replaced by IEC 80601-2-26:2019+A1:2024 for electroencephalographs.
  • IEC 60601-2-30 has been replaced by IEC 80601-2-30:2018 for automated non-invasive sphygmomanometers.
  • IEC 60601-2-49 has been replaced by IEC 80601-2-49.

Their inclusion in a KP3301 project should not be assumed automatically. The exact standard, edition, clause and required electrical network must be confirmed before quotation.

Application Scope

Typical DUT Applications

The KP3301 is primarily intended for patient-connected equipment and modules requiring defibrillation-related electrical protection evaluation.

Typical Equipment Under Test
  • Diagnostic electrocardiographs
  • ECG monitoring equipment
  • Multifunction patient monitors
  • ECG patient cables and lead systems
  • Respiration-monitoring input circuits
  • Compatible invasive blood pressure monitoring inputs
  • Compatible EEG or physiological monitoring inputs
  • Medical electrical systems with patient-connected applied parts

Typical Users
  • Medical device manufacturers
  • Third-party testing laboratories
  • Certification and inspection organizations
  • Product development laboratories
  • Medical electrical safety laboratories
  • Quality assurance and type-testing departments
  • Research and training institutions

The product’s suitability for a particular DUT depends on the applicable standard circuit, patient-lead configuration and required test method.

Supply Scope

Configuration and Accessories

Main Instrument

KP3301 Defibrillation-Proof and Energy Reduction Tester

Optional Lead-Switching Accessories
  • Manual defibrillation adapter
  • Automatic defibrillation lead converter box
  • DB9 serial communication cable for the automatic converter configuration
Documentation
  • Electronic user manual
  • Paper calibration certificate
  • Certificate of conformity
  • Warranty card

Test Leads and Connection Accessories
  • Four-color output test signal cable
  • Red and black output adapter cables with alligator clips
  • Y1-Y2 test lead
  • Yellow-green grounding wire
  • Connection posts
  • Aluminum test plate
  • Three-core power cord
  • Spare fuses

The final accessory quantities, connector arrangement and lead-switching configuration should be confirmed before shipment.

Before Ordering

Selection and Configuration Guide

Before ordering the KP3301, confirm the following information:

DUT and Applied Part
Confirm the medical equipment type and whether the patient-connected input is ECG, respiration, invasive pressure or another compatible applied part.
Standard and ClauseProvide the standard number, edition and applicable test clause.
Lead Configuration
Confirm the number and type of ECG or patient leads and whether manual or automatic lead switching is required.
Test Arrangement
Confirm common mode, differential mode or both, together with the required defibrillation protection, energy reduction or Y1-Y2 evaluation.
Verification and Documentation
Confirm whether external waveform, voltage or energy verification is required and whether the project requires a standard or accredited calibration certificate.
Configuration guidance:
The manual adapter is generally suitable for customized or lower-volume testing. The automatic converter box is more practical when several ECG leads must be tested repeatedly using the same sequence.

Compliance and Documentation Support

The KP3301 is designed to support selected defibrillation-proof, energy reduction and residual-voltage test arrangements associated with IEC 60601, IEC 80601 and related national or industry standards.

Compliance clarification:
The instrument itself does not certify the DUT or guarantee compliance. Final conformity depends on the complete test arrangement and the laboratory’s approved procedure.

Standard:
Applicable standard and edition, specific test clause, required test sequence and post-test acceptance criteria.
Test Network:
Selected resistance and inductance network, charging voltage and polarity, and measurement and verification instruments.
DUT Configuration:
Applied-part classification and DUT lead arrangement.
Laboratory Control:
Laboratory quality procedures.

Available Documentation:
Product datasheet, electronic user manual, calibration certificate, certificate of conformity and warranty documentation.

PDF

 

KP3301 Product Datasheet
IEC 60601-1 Defibrillation-Proof and Energy Reduction Tester
Technical specifications, test functions, applications, accessories and ordering information.

Technical Inquiry and Configuration Support

To review the appropriate KP3301 test configuration, please provide the available project information below. Not all details are required for the initial inquiry; KingPo can assist with the remaining configuration review.

1. DUT and Standard Information
  • DUT manufacturer, model and medical equipment type
  • Applicable standard, edition and test clause, if already identified
  • Applied-part type, such as ECG, respiration, invasive pressure or another patient-connected input

2. Required Test Configuration
  • Number and type of ECG or patient leads
  • Common-mode, differential-mode or combined test requirement
  • Required charging voltage and polarity, if specified by the test procedure
  • Energy-reduction and Y1-Y2 measurement requirements
  • Manual lead switching or optional automatic lead converter box

3. Interface and Documentation
  • Photographs, pin definitions or drawings of the DUT connector and patient-lead interface
  • Required calibration certificate, accredited calibration or traceability documentation
  • Any customer-specific test report, cable, adapter or documentation requirements

Configuration support:KingPo will review the supplied information to confirm the applicable test network, lead-switching method, adapter or converter-box configuration, connection accessories and documentation package before quotation.

Submit Technical Inquiry

Defibrillation-Proof and Energy Reduction Tester FAQs

What is a defibrillation-proof and energy reduction tester?
A defibrillation-proof and energy reduction tester generates controlled high-voltage test conditions to evaluate how patient-connected medical electrical equipment responds when exposed to the effects of defibrillation. Depending on the applicable standard and test circuit, the evaluation may include input protection, energy reduction, residual voltage and functional recovery after exposure.
What medical equipment can be tested with the KP3301?
The KP3301 is primarily intended for electrocardiographs, ECG monitoring equipment, multifunction patient monitors, ECG patient cables and compatible physiological monitoring inputs. The exact suitability depends on the DUT applied part, lead arrangement, applicable standard edition and required test circuit.
Is the KP3301 a defibrillator analyzer?
No. A defibrillator analyzer measures the energy and waveform delivered by a clinical defibrillator. The KP3301 performs the opposite side of the evaluation: it generates a controlled defibrillation-related electrical condition to test the protection and energy-reduction performance of patient-connected medical equipment.
Which standards can the KP3301 support?
The KP3301 is designed to support selected test arrangements associated with IEC 60601-1 and relevant particular standards for patient-connected medical equipment. Common project references may include IEC 60601-2-25 for diagnostic electrocardiographs, IEC 60601-2-27 for ECG monitoring equipment, IEC 60601-2-34 for invasive blood pressure monitoring equipment and IEC 80601-2-49 for multifunction patient monitors. The exact standard, edition, clause and circuit must be reviewed for each DUT before testing or quotation. IEC 60601-1 Edition 3.2 should also be used together with the applicable particular standard where one exists.
What is the maximum charging voltage of the KP3301?
The KP3301 provides a charging-voltage range of 0 to ±5.5 kV. Positive and negative polarity can be selected digitally, with a stated voltage-setting resolution of 1 V and accuracy of ±1%.
What is the difference between common-mode and differential-mode testing?
In a common-mode test, the applicable patient connections are grouped and exposed to the test condition relative to another reference point in the circuit. In a differential-mode test, the test voltage is applied between selected patient connections or lead groups. The differential-mode arrangement more directly stresses the protection between individual patient-input circuits. IEC 60601-2-25 includes separate common-mode and differential-mode defibrillation-protection test arrangements for electrocardiographs.
What is the energy reduction test?
The energy reduction test evaluates how much of the applied defibrillation-related energy is transmitted or dissipated through the DUT and associated test circuit. The KP3301 uses the 25 mH inductance configuration for this function and displays the calculated energy result with 1 J resolution. Its documented theoretical no-load reference values are approximately 364 J with the 10 Ω configuration and approximately 360 J with the 11 Ω configuration. These reference values are not universal DUT pass/fail limits.
What does the Y1-Y2 measurement represent?
The Y1-Y2 function is used for supported residual- or hazardous-voltage evaluations after the defibrillation-related test condition is applied. The KP3301 calculates the Y1-Y2 result internally, reducing the need to derive the value manually from disturbed oscilloscope signals. Independent voltage or waveform verification may still be required by the applicable standard, laboratory procedure or accreditation system. Integrated Y1-Y2 measurement is also a recognized function in professional defibrillation-proof testers.
Does the KP3301 automatically determine whether the DUT passes or fails?
Not by itself. The KP3301 provides the electrical test source, selectable network and supported measurement functions, but final acceptance must be determined from the applicable standard, test clause, DUT classification, required sequence and post-test criteria. A test result should therefore be reviewed as part of the complete laboratory procedure rather than treated as an automatic product-certification decision. IEC 60601-1 also states that the general standard must be used together with relevant particular standards where they exist.
Can the KP3301 test multiple ECG leads automatically?
Yes, when the main instrument is used with the optional automatic defibrillation lead converter box. The converter box switches selected ECG leads according to the programmed test sequence, reducing repeated manual reconnection during multi-lead testing. It is an auxiliary switching device; the KP3301 remains responsible for generating the high-voltage test condition and performing the supported calculations.
Does the KP3301 include ECG and respiration signal simulation?
Yes. The instrument provides a 10 Hz sine-wave signal with an adjustable amplitude from 0.5 mV to 10 mV, with a default setting of 5 mV. It also provides a respiration-rate signal adjustable from 5 to 60 rpm, with a default setting of 27 rpm. These signals can support functional observation of compatible ECG or respiration channels during the test setup.
Can the KP3301 be used for an external cardiac pacemaker?
Applicability should not be assumed solely because the equipment is described as defibrillation-proof. External cardiac pacemakers are covered by IEC 60601-2-31, which has its own test requirements and test-pulse arrangements. The 2020 edition also removed the former energy-reduction test requirement and revised the external-defibrillation exposure test. A separate configuration or dedicated pulse generator may therefore be required.

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