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.
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Adhesion of the Neutral Electrode 21pad
- 发起方
- Medline Industries
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Tests With No More Than 5% Separation - Neutral Electrode (NE) Adhesive Separation
- 状态
- 已完成
- 最后更新
- 去年
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Number of Tests With No More Than 5% Separation - Neutral Electrode (NE) Adhesive Separation
时间窗: 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