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1-877-RND-CALM (1-877-763-2256)

SEAM10 TENS Electrode Tester


The SEAM10 TENS Electrode Tester has been designed to test the impedance of TENS Electrodes under a wide range of current pulse inputs. Since there is no approved standard for determining the acceptable impedance/performance of TENS electrodes, the basis of the SEAM10 is derived from the AAMI NS4:1986/(R)2009 Transcutaneous Electrical Nerve Stimulator Standard.

 

 

       

In operation, the SEAM10 unit is connected to a computer to allow the user to set test parameter for up to 3 stored test conditions. Users can define:

  • Pulse characteristics:
    • Amplitude
    • Pulse width
    • Pulse Frequency
  • Operational Time:
    • Single point measurement (~5sec)
    • 3 Point measurement (user defined duration: minimum 30sec)
  • Pass/Fail Impedance Limit
  • Pass Warning Impedance Limit

Once programmed, the user can select any one of the 3 pre-programmed sequences. At the conclusion of the run the unit will display the impedance, PASS/FAIL indication and the defined test limit.

As a safety measure, the SEAM10 also includes a lid sensor to disable testing if the lid is opened at any point in the test sequence.

The SEAM10 has two different electrode interfaces for user flexibility. For single electrode tests, the TENS electrode is attached to a metallic plate then to the 0.080" pin. Dual electrode test are performed with the two TENS electrodes (gel-to-gel) with both leads connected to 0.080" pins.

Product Inquiries:

For more information on the SEAM10 TENS Electrode Tester send an email to info@calmtechnologies.com or call us at 1-877-763-2256

 

 

Guidance for Acceptance and Specification Limit Determination for TENS Electrodes

CALM Technologies offers the following Technical Note to manufactures of TENS Electrodes to suggest a method of determination for Quality Acceptance Limits based on the current available International Standards.  Click on the Link below to download a PDF version.  If you have any questions or comments on this document, feel free to contact us at info@calmtechnologies.com

TN-S04-0001 - TENS Test Limit Guidelines R0

 

Know your product

FDA suggests (Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Cutaneous Electrode; April 5 2010) “If the electrode is intended to apply electrical stimulation, the electrode design should ensure that the energy from the waveform/pulse generator is efficiently transferred to the patient. … We recommend that you perform impedance testing to assure that the electrode has conductive properties appropriate to the device’s intended use.” 

No tester for TENS electrodes has been able to simulate actual use… until now.  The SEAM10 allows you to adjust the simulated charge through the electrode for worst case testing.  Now you can investigate your gel quality and impedance over the entire range of intended use.

Current testers on the market apply as little as 1 µC and give a single reading.  As stated in AAMI NS4 1986:(R 2009), the optimal charge range required for pain relief is 3 µC to 18 µC.  One instantaneous reading at a charge insufficient for pain relief is not representative of intended use conditions.  These low charge testers on the market give low impedance readings with large variability making it impossible to assess your electrode quality under intended use conditions.

 

The SEAM10 Tester allows you to investigate your electrode performance up to a maximum of 30 µC

AAMI N4:1986/(R)2009  for Transcutaneous Electrical Nerve Stimulators section B3.2.2.2 suggests the following charge values:

 3 µC – minimum mean charge per pulse required to achieve pain relief

18 µC – maximum charge needed to achieve pain relief

25 µC – limited output charge for safety considerations

How does your product perform under worst case, intended use conditions?  High charge testing has shown that some product’s gel experience degradation, reducing adhesion and electrode performance.

 

Are you losing customers because they can only get one use out of your electrodes before getting frustrated?  How does your gel perform under long duration, high charge testing?

 Are you confident in giving the FDA answers to these questions?  The CALM Technologies SEAM10 Tester can help you.

 

 

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