呼吸设备.婴儿心肺监测器的基本安全和基本性能的特殊要求

[中文适用范围]： 本文件适用于 3.10 中定义的婴儿心肺监护仪（以下也称为 ME 设备）及其附件的基本安全和基本性能： ——用于家庭医疗保健环境； ——供非专业操作员使用； ——用于监测三岁以下儿童睡眠或休息时的心肺参数； - 旨在用于运输操作用途。 注：婴儿心肺监护仪也可用于专业医疗机构。 本文件也适用于制造商打算连接到婴儿心肺监护仪的配件，这些配件的特性可能会影响婴儿心肺监护仪的基本安全或基本性能。 探头、电缆分布式报警系统示例 [外文原描述]： This document applies to the basic safety and essential performance of an infant cardiorespiratory monitor, as defined in 3.10, hereafter also referred to as ME equipment, in combination with its accessories : — intended for use in the home healthcare environment ; — intended for use by a lay operator ; — intended to monitor cardiorespiratory parameters in sleeping or resting children under three years of age; and — intended for transit-operable use. NOTE An infant cardiorespiratory monitor can also be used in professional health care facilities. This document is also applicable to those accessories intended by their manufacturer to be connected to the infant cardiorespiratory monitor , where the characteristics of those accessories can affect the basic safety or essential performance of the infant cardiorespiratory monitor . EXAMPLE probes, cables distributed alarm system