NCT05376787

Verify the Performance of the Neutral Electrode (NE) Adhesives

The Purpose of This Study is to Verify the Performance of the Neutral Electrode (NE) Adhesives in Accordance With the Testing Specified in IEC 60601-2-2:2017, Section 201.15.101.7, Pull Test.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Medline Industries · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

• Adhesion of the Neutral Electrode 21pad

Interventions

Type	Name	Description
DEVICE	Medline NE Grounding Pad	Split Universal Grounding Pads

Timeline

• Start date: 2022-05-30
• Primary completion: 2022-06-10
• Completion: 2022-06-10
• First posted: 2022-05-17
• Last updated: 2024-10-17
• Results posted: 2024-10-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study