MegaPulse Defib-5 Surge Tester

VIDEO : Defib-5 Setup and Operation

VIDEO : Defib-5 Capacitor Options

The Defib-5 is designed to test defibrillation-proof circuits of medical products as required by the IEC. Now updated to the requirements of IEC 60601-1:2005, it generates the waveform required by IEC 60601-1:2005 Figure 10 (IEC 60601-1, Amendment 2 (1995), Clause 17h). In accordance with these Standards, the Defib-5 can generate the required waveform with up to 5,000 volts peak. A front-panel switch reverses the output polarity.
A port for energy calculation as required in the standard is supplied; an optional energy calculation method is also available. Our resistor bank is stable; see the plots of resistance over time during the pulse here. If the duty cycle of the Defib-5 is kept to one pulse every 30 seconds continuous, we keep the resistance within 5% of the stated value. The accuracy of the resistor bank throughout the pulse and from pulse to pulse during the testing cycle is imperative if the energy calculations are to be accurate and meaningful over the complete test sequence.
The output of the Defib-5 agrees with the Pspice simulation of the circuit, proof that the inductor is not saturating, and the resistor bank is operating correctly.
The Defib-5 provided with a BNC oscilloscope output, used to connect the oscilloscope to the measurement points in your circuitry, in accordance with IEC 60601-1. Click here to see IEC 60601-1:2005 Figure 10, (IEC 60601-1: 1998 Figure 50), which is a schematic of the test circuit. We have modified the schematic and added blue boxes around the schematic parts included in the Defib-5.
The Defib-5 offers a complete test solution. The patient connections of your product are connected to the OUTPUT jack of the Defib-5 and the SIP/SOP being tested is connected to the MEASURING POINT jack of the Defib-5; and an oscilloscope is connected to the BNC outputs of the Defib-5. The oscilloscope is configured in Y1-Y2 mode, and test results are shown on the oscilloscope. If the resulting waveform has a maximum amplitude of 1V or under, the product passes. A barely passing oscilloscope waveform sample is shown on our Defib-5 Pass-Fail Reference page.

The Defib-5 can also be configured with our Option 13, which substitutes resistance and inductor values to conduct the test shown in IEC 60601-1:2005 Figure 11. In addition, the 25mH and 400 ohm substituted values allow testing to AAMI EC-13 and IEC 60601-2-49, among others. Please note that Option 13 is required to test to both Fig. 10 and Fig. 11 of IEC 60601-1:2005.

Please see the FAQ for more detailed information.

Compliance laboratories worldwide have added the Defib-5 to their test equipment in order to perform these tests. Why not have one in your lab to make sure your equipment will pass before the type testing at the laboratory?

MegaPulse Defib-5 ships with cables, graphs of theoretical and actual waveforms, and a Calibration Certificate. One-year warranty. We have developed many options for the Defib-5; including relay outputs for PLC control (Option RI); computer-controlled pulse programs (Option TMMD); continuous full voltage maintenance (Option VH); and a production line test package consisting of 12 sec. charge, continuous duty with autotrigger at 5000V with high repeatability (Option FCD); and an automated Energy Calculation package (Option DGSB), described below.

The capacitor bank will deliver 20,000 continuous cycles before replacement is required. If the Defib-5 is used in a laboratory environment when continuous use is not anticipated, the life of the capacitor bank will be considerably longer, as the heating of the capacitor bank causes its demise. If more life is needed, order Option DC which substitutes a capacitor bank with a 2.5M continuous cycle lifetime. Option FCD takes Option DC and adds 12 second continuous cycle times, and an autotrigger circuit at 5000V for production line testing use.

See a video describing the Option DC capacitor bank.

The MegaPulse Defib-5 Pass - Fail Reference is available for use in verifying test setups and tester function. The ease of use of the Reference and its ability to find problems in the Defib-5 operation and the test setup itself make this a highly recommended Option.

Energy measurement is required by IEC 60601-1 and IEC 60601-2-27. Compliance West offers a software solution for directly reporting energy measurement as well as for waveform capture and redisplay. Please see details at our Option DGSB page.

Also available is the MegaPulse Defib-5 EC-13 Operator Safety Tester, designed to test to the requirements of AAMI EC-13, 2002 Edition, Para. 5.2.2.2.3. It additionally can test to the requirements in IEC 601-2-49. This is a stand-alone tester for those not requiring the IEC 60101 capability. View the circuit schematic here. (Please note that the EC-13/IEC601-2-49 capability can optionally be added to the regular Defib-5 (IEC 601-1) tester for multiple capabilities.)

Open circuit and short circuit waveforms can be viewed by clicking the links below:
IEC 60601 Table 50 Voltage Duration waveform.
IEC 60601 Table 50 Voltage Rise waveform.
IEC 60601 Table 50 Current Duration waveform.
IEC 60601 Table 50 Current Rise waveform.

MegaPulse Defib-5 Surge Tester.

MegaPulse Defib-5 EC-13 Operator Safety Tester.

    TOP

Designed to test defibrillation-proof circuits of medical products as required by the IEC.

    TOP

Option RI: PLC Interface Board
Option FCD: Production Test Package.
Option VH: Voltage Hold.
Option TMMD: TestMinder for computer-conducted pulse train testing.
Option DGSB: Energy Measurement Software
Option 13: EC13/IEC60601-2-49 Test Function: When equipped with this option, the Defib-5 can also provide the pulse to test to ANSI/AAMI EC13:2002, "Test circuit for operator safety test", Paragraph 5.2.2.2.3. It is also correctly configured to produce the waveform required in IEC60601-2-49, Figure 101. Click here to see a representation of the option, using Figure 9B from the EC-13 Standard. We also offer an explanatory white paper regarding the output of the EC-13 option. Waveforms can be viewed as well:
EC-13 Open Circuit Voltage Waveform
EC-13 Short Circuit Current Waveform
EC-13 Voltage Waveform: 100 ohm load
EC-13 Voltage Waveform: 50 ohm load
EC-13 Voltage Waveform: 25 ohm load
Option 27: IEC 60601-2-27 Figure 101, 104 and 105 Test Function: When equipped with this option, the Defib-5 is equipped with 100 ohm verification jacks, a BNC signal generator input, and S2 as noted in the Standard. (S2 is substituted with Zener diodes or a 470 ohm resistor).
Optional 240V Mains power.
Optional Pass/Fail Reference: Defib-5 Pass-Fail
Option P6015: High Accuracy Tektronix Probe for proper waveform measurement

    TOP

Generates the waveform required by IEC 60601-1, Amendment 2, clause 17h for testing of defibrillation-proof circuits.

Designed with operator safety in mind: Set up the EUT to the right and behind the tester, and a right-handed operator will find himself standing to the left of the tester, allowing maximum separation.

Theoretical graphs and actual graphs showing the output of your tester are included with each MegaPulse Defib-5, allowing easy sanity checks and proof to visiting agency engineers of test setups.

BNC Oscilloscope output allows quick connections and easy evaluation of output waveforms, in accordance with Figure 50 of IEC 60601-1.

Reverse polarity waveforms available by pushing a button on the front panel. No need to change the test setup. Positive polarity indication minimizes errors.

Front panel voltage meter shows residual voltage in charging circuit for safer operation.

1-year calibration cycle.

All test leads included.

1 year warranty

    TOP