Neonatal Intensive Care Unit Telemetry System

描述（由申请人提供）：目的是开发一种微型、无线、多通道、新生儿重症监护室（NICU）和监护系统，提供生理和行为参数。该系统采用小型生理监测仪和isolette安装的摄像机。NICU是一个极具挑战性的环境，因为患者体型小，身体脆弱，周围有笨重的设备。目前的床边设备大而笨重，这妨碍了护理并抑制了临床业务。连续的生理监测可以提供指导诊断和治疗的关键数据。一个不显眼的监测系统，可以直接放置在隔离将允许连续监测，同时最大限度地减少病人的危险和不便。最终的商业系统将提供一个小型，轻便的无线系统，用于不引人注目的NICU监测。特别是在第二阶段的持续努力中，我们计划升级无线电链路，增加外部传感器选项，最大限度地降低成本，并确保系统符合医疗设备质量标准。软件升级将提高用户友好性，整合新的工具来比较研究，并提供可定制的报告功能。新的算法将被整合，以提高实用性和研究的灵活性。重要的验证和确认测试将确保符合所有适用标准。最后，将在新生儿受试者中完成一项大型临床试验，以确保临床疗效。

DESCRIPTION (provided by applicant): The objective is to develop a miniature, wireless, multi-channel, neonatal intensive care unit (NICU) & monitoring system that provides physiological and behavioral parameters. The system utilizes a small physiological monitor and isolette mounted camera. The NICU is an extremely challenging environment since patients are small, medically fragile, and surrounded by bulky equipment. Current bedside devices are large and cumbersome, which impede nursing care and inhibit clinical traffic. Continuous physiologic monitoring can provide critical data to guide diagnosis and treatment. An unobtrusive monitoring system that can be placed directly into the isolette would allow continuous monitoring while minimizing patient hazards and inconvenience. The final commercial system will provide a small, lightweight wireless system for unobtrusive NICU monitoring. Specifically during the continuing Phase II effort, we plan to upgrade the radio link, increase external sensors options, minimize cost, and ensure the system meets medical equipment quality standards. Software upgrades will improve user friendliness, integrate new tools to compare studies, and provide customizable reporting features. New algorithms will be integrated to improve utility and research flexibility. Significant verification and validation testing will ensure that all applicable standards are met. Finally a large clinical trial will be completed with neonatal subjects to ensure clinical efficacy.