Defib-5 Pass-Fail
Defib Surge Tester
DF-1
DF-80
360J
VIDEO : Defib-5 Setup and Operation
VIDEO : Defib-5 Capacitor Options
VIDEO: Defib-5 Waveform Capture
VIDEO : Defib-5 Capacitor Options
VIDEO: Defib-5 Using the Energy Port to conduct the Energy Measurement Test
VIDEO: Defib-5 Energy Measurement Determination via Excel
WHITE PAPER: Oscilloscope Setup to Capture Y1-Y2 waveform in accordance with Iss. 3 Fig. 10
DOWNLOAD: Excel File Example of Energy Measurement using a Digital Oscilloscope
DOWNLOAD: Digital Oscilloscope raw data example; for use with energy meas. Excel file above.
FAQ: Defib-5 Operation and Capabilities FAQ
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?
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, EC-13 and others, it generates the waveforms required by the following Standards:
| Standard | Fig. Ref. | Inductor | R+RL | Energy Meas.? |
|---|---|---|---|---|
EC-53 |
7 |
25 mH |
11 |
No |
EC-13 |
9A |
25mH |
≤11 |
Yes |
EC-13 |
9B |
25mH |
≤11 |
No |
IEC 60601-1 2005 |
9 (C) |
500uH |
≤10 |
No |
IEC 60601-1 2005 |
10 (C) |
500uH |
≤10 |
No |
IEC 60601-1 2005 |
11 (C,D) |
25mH |
11 |
Yes |
IEC 60601-2-2 |
- (C) |
500uH |
≤10 |
No (2kV pulse) |
IEC60601-2-34* |
102 (-) |
500uH |
≤10 |
No |
IEC60601-2-49 |
101 (C,D) |
25mH |
11 |
Yes |
IEC 60601-2-27 |
101 (C) |
500uH |
≤10 |
No |
IEC 60601-2-27 |
104 (D) |
500uH |
≤10 |
No |
IEC 60601-2-27 ` |
105 (C) |
500uH |
≤10 |
No |
IEC60601-2-27 |
107 (D) |
500uH |
≤10 |
No |
IEC 60601-2-27 |
108 (C) |
500uH |
≤10 |
No |
IEC60601-2-30 |
101 (-) |
500uH |
≤10 |
No |
EC-11 |
5B (C) |
25mH |
11 |
No |
EC-11 |
5A (D) |
25mH |
11 |
No |
Note: Do not rely on this list. Email corrections and additions to jeff@compwest.com.
* Option required for this test. Contact factory for details.
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 vaccuum 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; 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 at all times. 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 Defib-5 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.
| Standard | Fig. Ref. | Y1-Y2 Measurement? |
Sig Gen Input? |
|---|---|---|---|
EC-53 |
7 |
No |
No |
EC-13 |
9A |
No |
Yes |
EC-13 |
9B |
Yes |
No |
IEC 60601-1 2005 |
9 |
Yes |
No |
IEC 60601-1 2005 |
10 |
Yes |
No |
IEC 60601-1 2005 |
11 |
No |
No |
IEC 60601-2-2 |
- |
No |
No |
IEC60601-2-34 |
102 |
Yes |
No |
IEC60601-2-49 |
101 |
No |
No |
IEC 60601-2-27 |
101 |
Yes |
No |
IEC 60601-2-27 |
104 |
No |
Yes |
IEC 60601-2-27 ` |
105 |
No |
Yes |
IEC 60601-2-27 |
107 |
No |
Yes |
IEC 60601-2-27 |
108 |
No |
No |
IEC 60601-2-30 |
101 |
Yes |
No |
EC-11 |
5B |
Yes |
No |
EC-11 |
5A |
No |
Yes |
Note: Do not rely on this list. Email corrections and additions to jeff@compwest.com.
Both the Y1-Y2 circuit and the BNC for connecting a signal generator are included with the Defib-5. 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-5 and the SIP/SOP being tested is connected to the MEASURING POINT jack of the Defib-5. 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.
MegaPulse Defib-5 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-5; please see Options Section below for further info.
Capacitor bank life:
Standard Defib-5: 20,000 continuous cycles.
Defib-5 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, 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 Defib-5 is equipped with a mechanical relay which offers good waveforms and long life. If a Vacuum 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-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. We can offer three methods to obtain the energy measurement results required:
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.
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.
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
To demonstrate the correlation between our true outputs (linked above), we also have posted the circuit simulations for the circuit shown in IEC 60601; and the circuit shown in EC-13.
Defib-5 simulation
EC-13 simulation
MegaPulse Defib-5 Surge Tester.
MegaPulse Defib-5 EC-13 Operator Safety Tester.
Designed to test defibrillation-proof circuits of medical products as required by the IEC.
TOPOption GVAC: Vacuum relay
Option RI: PLC Interface Board
Option FCD: Production Test Package.
Option VH: Voltage Hold.
Option TMM: TestMinder for computer-conducted pulse train testing.
Option DGSB: Energy Measurement Software
Option 100X: Jumper to allow direct Energy Measurement readings using Fluke 7000DP and 7010
Optional 240V Mains power.
Optional Pass/Fail Reference: Defib-5 Pass-Fail
Option P6015: High Accuracy Tektronix Probe for proper waveform measurement
Option GVAC: Gigavac relay switch for the most accurate pulse delivery possible.
