Sensor Off Study Using a Nellcor USB Pulse Oximetry Monitor Interface Cable
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Report the Time Until the Device Posts "Sensor Off" After the Sensor is Removed
研究概览
简要总结
The purpose of this study is to validate that the device posts a Sensor-Off message within the time frame stated in the proposed claims.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects 18 or older (inclusive)
- •Subject is able to participate for the duration of the study
- •Subject is willing to sign an informed consent
排除标准
- •Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test sensors
- •Physiologic abnormalities that prevent proper application of pulse oximetry sensor
- •Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes
研究组 & 干预措施
Nellcor USB Pulse Oximeter Monitor Interface Cable Sensor Test
干预措施: Nellcor USB Pulse Oximeter Monitor Interface Cable (Device)
结局指标
主要结局
Report the Time Until the Device Posts "Sensor Off" After the Sensor is Removed
时间窗: 1 minute per event, multiple events per subject. Total duration up to 1 hour
A series of sensor-off events were collected from subjects in the study using marketed, off-the-shelf sensors. Each event was marked as pass if event duration (Timeend - Timestart) was less than or equal to 60 seconds; otherwise, the event was marked as greater than or equal to 60 seconds. The acceptance criteria is if 90% of the time the product posts Sensor Off, or any equal or higher priority alarm, within 60 seconds after sensor is removed.
次要结局
未报告次要终点