MegaPulse D8-PF Defib-proof and Energy Reduction Tester for IEC 60601, IEC 80601, EC-13, EC-53: 5000V 360J Medical Tester

Datasheet

MegaPulse D8-PF:
MegaPulse D8-PF Defib-proof and Energy Reduction Tester for IEC 60601, IEC 80601, EC-13, EC-53: 5000V 360J Medical Tester

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The most advanced medical surge tester available, the MegaPulse D8-PF is the latest iteration of the industry leading Defib-proof Tester from Compliance West.  It adds the new Differential Mode Test shown in IEC 80601-2-26 and introduces our new touch controlled front panel to the legendary MegaPulse D5-PF defib proof tester.  The MegaPulse D8-PF retains the direct energy readout and comprehensive list of included tests to the requirements of:

  • IEC 80601-2-26:2019/COR1:2021 Figure 201.101 Defibrillation-Proof Applied Parts (S/N 435193 and up). If your MegaPulse D8-PF S/N is lower than 435193, please contact us for upgrade information.

  • IEC 60601-1:2005 (Issue 3) Figure 9 and 10 Defib-proof Differential- and Common-Mode Test  (IEC 60601-1 Figure 50 in older versions).
  • IEC 60601-1:2006 Figure 11 Energy Reduction Test.
  • IEC 60601-2-4: 2010 Figure 201.110 Overload Test (optional).
  • IEC 60601-2-34 Issue 2 (optional).
  • IEC 60601-2-34 Issue 3 (included).
  • IEC 60601-2-49.
  • EC-13.
  • EC-53.
  • IEC 60601-2-25:2011.
  • IEC 60601-2-27:2011.

This is an IEC 60601 and IEC 80601 Defibrillation-proof tester.  For the Energy Reduction test, joules consumed in the 100Ω resistor are immediately displayed after each pulse. The MegaPulse D8-PF tests protection against the effects of defibrillation (Common Mode, Differential Mode) and Energy reduction test (EC-13) and as noted in the Standards shown above. The MegaPulse D8-PF outputs a 360J Defib-proof test pulse per IEC 60601-1 for the Energy Reduction Test.  It can also be used as a Defibrillator Lead Tester. 

Upgrades to allow your existing MegaPulse D5-PF to conduct the test described in IEC 80601-2-26 Figure 201-102, Defib-proof testing in Differential Mode, are available from us.  Please contact us for further information.

Detailed Information about the MegaPulse D8-PF

White Paper - Oscilloscope Setup to Capture Y1-Y2 waveform in accordance with Iss. 3 Fig. 10

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Features

  • Direct Joules readout on front panel after Energy Reduction Test.
  • Increased accuracy in accordance with IEC 60601-2-25 and -2-27:2011 requirements.
  • 20 second period between pulse delivery,
  • Increased signal generator voltage for -2-27 tests (Order Option SG).
  • Integrated Pass/Fail reference for checking the equipment and test setup.
  • Dry Capacitor delivers >2.5M pulses at 20 second intervals.
  • Integrated energy measurement, see demonstration video.
  • USB Testminder, Computer Control.
  • External interlock, disables HV output and defeats test when circuit is open.
  • Ergonomically designed for safety, speed and efficiency.
  • Front panel indicates polarity
  • Output voltage and polarity are controlled manually on front panel or via TestLink.
  • Cables, manual and calibration certificate included.
  • One year calibration cycle.
  • One year warranty.

Specifications

Output Voltage:0-5000 V ±1%
Main Capacitance:32 uF ±5%
Inductances500uH and 25 mH ±10%
Main Resistances100 Ω, 50 Ω and 400 Ω ±1% non inductive
Voltage ControlManually, by turning a knob in the front panel
Polarity controlPositive and Negative. Alternating control available with optional computer control
Polarity ControlPositive an Negative, by front panel push button
Duty Cycle1 Pulse every 20 Seconds *optional 12 Seconds
Voltage Display4 Digits LED Display
Voltage Resolution5 Volt
Line Voltage120 VAC AC, 50/60 Hz *optional different line voltages available (100V, 110V, 220V, 230V, 240V)
Operating Temperature15-40 ºC
Relative Humidity Range0-90% non-condensing
Dimensions17" wide x 11" high x 17" in deep

Manuals

Download Manual
MegaPulse D8-PF/MegaPulse D8-PF Rev 3.pdf Download Manual
Waveforms/IEC 60601-1 Figure 10 simulation.pdf Download Manual
Waveforms/IEC 60601-1 Fig. 10 Voltage Duration Waveform calculated.pdf Download Manual
Waveforms/IEC 60601-1 Fig. 10 Voltage Peak Waveform actual.pdf Download Manual
Waveforms/IEC 60601-1 Fig. 10 Voltage Rise Waveform calculated.pdf Download Manual
Waveforms/IEC 60601-1 Fig. 10 Voltage Rise Waveform actual.pdf Download Manual
Waveforms/IEC 60601-1 Fig. 10 Current Duration Waveform calculated.pdf Download Manual
Waveforms/IEC 60601-1 Fig. 10 Current Rise Time Waveform calculated.pdf Download Manual
Waveforms/EC13 Voltage Duration Waveform calculated.pdf Download Manual
Waveforms/EC13 Voltage Duration Waveform actual.pdf Download Manual
Waveforms/EC13 Voltage Rise Waveform actual.pdf Download Manual
Waveforms/EC13 Current Duration Waveform calculated.pdf Download Manual
Waveforms/EC13 Voltage Duration 100 Ohm Load Waveform calculated.pdf Download Manual
Waveforms/EC13 Voltage Duration 50 Ohm Load Waveform calculated.pdf Download Manual
Waveforms/EC13 Voltage Duration 25 Ohm Load Waveform calculated.pdf Download Manual

Contact Us

Corporate Sales Office (USA)

Compliance West USA
650 Gateway Center Way Suite D
San Diego, CA 92102 USA

US Representatives

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