Adhesion of the Neutral Electrode 21pad
Conditions
Brief 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.
Interventions
DEVICEMedline NE Grounding Pad
Split Universal Grounding Pads
Sponsors
F2 Labs
Medline Industries
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Tests With No More Than 5% Separation - Neutral Electrode (NE) Adhesive Separation | Up to 20 minutes - (10 minutes w. Pull for 10 to 10.25 minutes, in a plane parallel to the NE pad & At 10 mins, change direction of pull to y direction) | To determine the percentage of adhesion separation by only measuring test results that had no more than 5% of the NE adhesive area separated. At Point A where the NE connects to the pad, connect a cord to pull on the cable. Pull for 10 to 10.25 minutes, in a plane parallel to the NE pad and in a direction away from the center of the pad, with 10 to 11N (1.02 to 1.12kg) of force in the direction along the minor dimension of the pad. Set the height of the pulley so that the direction of pull shall be approximately co-planer with the plane of the connection point of the NE. The pull shall be performed by a cord connected to the NE at the cable connection point. See Figure 2 for the pull set up. The weights provide the required pull force. Start timer. At 10 mins, change direction of pull to y direction by rotating the pulley system 90 degrees as shown in Figure 2 - apply 10 to 11 N force at Point A in direction of y ray which is in a plane parallel to the pad. Start timer. At 10 mins |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Subjects Subjects must be 18 years old or over, willing to shave or have shaved the sites where the neutral electrodes will be placed. Subjects also must not be pregnant, breastfeeding, have skin conditions (such as eczema, sensitivities, allergies to adhesives, sunburn).
Medline NE Grounding Pad: Split Universal Grounding Pads | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Healthy Subjects | — |
|---|---|---|
| Age, Categorical <=18 years | 20 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 20 participants | — |
| Sex: Female, Male Female | 10 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Number of Tests With No More Than 5% Separation - Neutral Electrode (NE) Adhesive Separation
To determine the percentage of adhesion separation by only measuring test results that had no more than 5% of the NE adhesive area separated. At Point A where the NE connects to the pad, connect a cord to pull on the cable. Pull for 10 to 10.25 minutes, in a plane parallel to the NE pad and in a direction away from the center of the pad, with 10 to 11N (1.02 to 1.12kg) of force in the direction along the minor dimension of the pad. Set the height of the pulley so that the direction of pull shall be approximately co-planer with the plane of the connection point of the NE. The pull shall be performed by a cord connected to the NE at the cable connection point. See Figure 2 for the pull set up. The weights provide the required pull force. Start timer. At 10 mins, change direction of pull to y direction by rotating the pulley system 90 degrees as shown in Figure 2 - apply 10 to 11 N force at Point A in direction of y ray which is in a plane parallel to the pad. Start timer. At 10 mins
Time frame: Up to 20 minutes - (10 minutes w. Pull for 10 to 10.25 minutes, in a plane parallel to the NE pad & At 10 mins, change direction of pull to y direction)
Population: Healthy participants. Adhesion testing was done on each leg, so there was a total of two tests per participant. A total of 40 tests were done.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Healthy Subjects | Number of Tests With No More Than 5% Separation - Neutral Electrode (NE) Adhesive Separation | 39 Tests |