Defib Proof Circuit Tester (IEC60601 and AAMI Standards)

Compliance West introduces the Defib-5P, the first defib-proof tester to use a USB computer connection for remote operation. Now, any computer with a USB connection can control the Defib-5P. This will allow increased flexibility in setups, and offers a more robust and problem resistant connection.

The USB connection of the Defib-5P uses an isolated USB/RS-232 solution. The USB connection on the computer side allows great flexibility for the use to connect to a wide variety of computers without the need for a special card or computer. On the test equipment side, the interface is RS-232, which offers a stronger, more error-free protocol for more trouble-free operation.

The Defib-5P 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, EC-13 and others, it generates the waveforms required by the following Standards:

All waveforms can be delivered with a 5000V charge on the bulk capacitor. The front panel meter reads bulk capacitor voltage so it is clear when to fire the pulse. The 2kV pulse required by IEC 60601-2-2 is set with the front panel voltage knob.

Output polarity is reversible with a front panel button.

For the ultimate in pulse delivery we are proud to offer an optional Gigavac Gas Filled relay in place of our standard mechanical relay. Order option GVAC.

A port for energy calculation as required in the Standard is supplied on the rear panel. Further information on this topic is here.

A further note on Energy Measurement Calculation: If the energy calculations are to be accurate, the impedance of the resistor bank must remain stable throughout the pulse and from pulse to pulse during the testing cycle. We have designed our resistor bank to be stable; see the plots of resistance over time during the pulse here. If the duty cycle of the Defib-5P is kept to one pulse every 30 seconds continuous, we keep the resistance within 5% of the stated value at all times. This is important because IEC 60601-1 requires a 5% tolerance for the resistor bank; any excursion outside that envelope will invalidate the test.

The Defib-5P provided with differential BNC oscilloscope outputs measuring the error signal at Y1-Y2, and inputs for a signal generator in accordance with the following Standard requirements.

Both the Y1-Y2 circuit and the BNC for connecting a signal generator are included with the Defib-5P. Click here to see IEC 60601-1:2005 Figure 10, (IEC 60601-1: 1998 Figure 50), which is a schematic of the test circuit using the Y1-Y2 measurement. We have modified the schematic and added blue boxes around the schematic parts included in the Defib-5. When the Y1-Y2 measurement is needed, the patient connections of your product are connected to the OUTPUT jack of the Defib-5P and the SIP/SOP being tested is connected to the MEASURING POINT jack of the Defib-5P. An oscilloscope is connected to the BNC outputs of the Defib-5P. 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.

MegaPulse Defib-5P ships with cables, graphs of theoretical and actual waveforms, and a Calibration Certificate. See configurations here. One-year warranty. We have developed many options for the Defib-5P; please see Options Section below for further info.

Capacitor bank life: Standard Defib-5: 20,000 continuous cycles. Defib-5P with Option FCD or Option DC: 2.5M continuous cycles. Notes: 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. 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 Defib-5P is equipped with a mechanical relay which offers good waveforms and long life. If a Gas filled relay is desired instead, order Option GVAC.

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-5P 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. We can offer three methods to obtain the energy measurement results required:

1. Order Option 100X to allow use of your Fluke 7000DP and 7010 External Load Box to read energy directly. Option 100X opens the 100 ohm resistor in the Defib 5P and allows the resistance in the Fluke 7000DP Fluke 7010 set to the 100 ohm setting to be used in this test. The Fluke combination calculates the energy in the 100 ohm resistor.
2. For customers who have an existing GPIB data collection system operating under LabView, our Option DGSB will allow the Defib-5P to interface it. Please see details at our Option DGSB page.
3. We have also conducted an exercise in Excel to calculate and report energy measurements using a digital scope which can upload its datapoints to Excel. See the results of our Excel exercise here.

Also available is the MegaPulse Defib-5P 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.