Verify the Performance of the Neutral Electrode (NE) Adhesives

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-30

Study Completion Date

2022-06-10

Brief Summary

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The purpose of this research study is to determine the neutral electrode 21pad adhesion to the skin in accordance with international standard IEC 60601-2-2 section 201.15.101.7. A neutral electrode is placed on the body of patients undergoing surgery that involves the use of electric current, to protect them from the harmful effects of the electricity.

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Detailed Description

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Two neutral electrodes will be applied to the front of your thighs. The study staff will set up and attach a pulley system to the neutral electrodes. The purpose of the pulley system is to apply a force pulling the neutral electrode away from your body. The force will be applied for 10 minutes on each neutral electrode in one direction, and then for another 10 minutes in a second direction. Site staff will mark any areas of separation and the neutral electrodes will be removed.

Conditions

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Adhesion of the Neutral Electrode 21pad

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Subjects

Participants must be willing to comply with all study procedures Participants must be willing to shave, or to have shaved, the sites where the neutral electrodes will be placed.

Medline NE Grounding Pad

Intervention Type DEVICE

Split Universal Grounding Pads

Interventions

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Medline NE Grounding Pad

Split Universal Grounding Pads

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Participants must be willing to comply with all study procedures
* Participants must be willing to shave, or to have shaved, the sites where the neutral electrodes will be placed.

Exclusion Criteria

* The participant has any skin conditions (e.g. eczema, sensitivities, allergies to adhesives, sunburn, etc.) at the application sites that might be adversely affected by the application of an adhesive pad.
* The participant is pregnant or breastfeeding.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes