上海 FDA呼吸暂停监护仪注册审评技术要求如何撰写

根据FDA 对呼吸暂停监护仪注册申报技术要求，以下内容是必不可少的：

Suggestions for Design and/or Features of Apnea Monitors

呼吸暂停监护仪要求的设计和特征

An apnea monitor should have:

呼吸暂停监护仪应具备:

• at least one primary/direct means for detecting apnea;

• 至少一种用于检测呼吸暂停的主要/直接手段;

• at      least one secondary/indirect means for detecting apnea, e.g., heart rate;

• 至少一种用于检测呼吸暂停的次要/间接手段，例如心率;

• a      timer to measure the duration of apneic episodes;

• 计时器测量呼吸暂停发作的持续时间;

• visual      and audible alarms to signal an apneic episode;

• 发出窒息发作信号的视觉和听觉警报;

• visual      and audible alarms to signal a secondary/indirect condition due to an      apneic episode; and

• 视觉和听觉警报，以表明由窒息发作引起的继发性/间接性疾病;和

• a      sensor fault alarm for both primary/direct and secondary/indirect means of      detecting apnea which activates within 5 seconds of a sensor failure.

• 一种传感器故障警报，用于主要/直接和次要/间接检测呼吸暂停，在传感器故障后5秒内激活。

  
  

The primary/direct detection method should be one of the following types:

主要/直接检测方法应是下列类型之一:

• methods for detecting central apnea only;

• 仅检测中枢呼吸暂停的方法;

• methods      for detecting both obstructive apnea and central apnea without      distinguishing between them; or

• 不区分阻塞性呼吸暂停和中枢性呼吸暂停的检测方法;或

• methods      for detecting both types of apnea and distinguishing between them.

• 检测两种类型的呼吸暂停和区分它们的方法。

Examples of methods for detecting central apnea only include: impedance pneumography, inductive plethysmography, and pneumatic abdominal sensors. Methods of detecting both central and obstructive apnea without distinguishing them include: airway thermistors, carbon dioxide sensors, and proximal airway pressure sensors. An example of a method capable of detecting both and distinguishing between them is respiratory inductance plethysmography. Combinations of these methods can be used to monitor both types of apnea and distinguish between them.

检测中枢性呼吸暂停的方法示例仅包括:阻抗气相造影术、感应容积脉搏波造影术和气动腹部传感器。不区分中枢性和阻塞性呼吸暂停的检测方法包括:气道热敏电阻、二氧化碳传感器和近端气道压力传感器。能够检测两者并区分它们的方法的一个示例是呼吸感应容积脉搏波。这些方法的组合可用于监测两种类型的呼吸暂停并加以区分。

The secondary/indirect methods of detecting apnea measure physiologic parameters that change as a result of apnea. For example, apnea may lead to hypoxia, which in turn may lead to bradycardia. Therefore, both pulse oximetry and heart rate monitoring can be used as secondary detection methods.

检测呼吸暂停的次要/间接方法测量因呼吸暂停而改变的生理参数。例如，呼吸暂停可能导致缺氧，而缺氧又可能导致心动过缓。因此，脉搏血氧仪和心率监测都可以作为二次检测方法。

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