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The intended use of TigerConnect Alarm Management is to provide an interface with clinical systems to forward information associated to the particular event to the designated display device(s).

For medical alarms, TigerConnect Alarm Management is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events TigerConnect Alarm Management does not alter the behavior of the primary medical devices and associated alarm annunciations. The display device provides a visual, and/or audible and/or vibrating mechanism upon receipt of the alert.

TigerConnect Alarm Management is intended for use as a secondary alert. It does not replace the alarm function on the primary device.

TigerConnect (TC) Alarm Management is a software as a medical device (SaMD) installed on the Amazon Web Services (AWS) TigerConnect cloud capable of acquiring alarms, events, and parameters from healthcare systems, and intelligently forwarding this information as secondary notifications to designated commercial endpoint devices. The endpoint devices act as non-regulated medical device data system (MDDS) devices that display the information from TC Alarm Management.

TC Alarm Management is intended for use as a secondary alarm; it does not replace the alarm function on the primary device.

Users receive interactive, time-critical information from clinical systems directly via their endpoint devices as text (visual) or alarms (audible) or data. Received attributes related to the presentation of alerts include color and quantity of tones (beeps) in addition to, and in coordination with, event priorities. TC Alarm Management allows users to be aware of their patients' status and alarm conditions when they are away from the patient and patient monitoring system.

A portion of the software, the Health Services Agent, is deployed to the customers' premises using ECS Anywhere, an extension of Amazon ECS that allows customers to run native ECS tasks on customer-managed infrastructure without compromising on the simplicity and control of the cloud. ECS Anywhere must be deployed in a customer provided virtual machine prior to implementing the Health Systems Agent. This allows TC Alarm Management to securely send, receive, process, and appropriately encrypt data from systems that are typically unencrypted.

TC Alarm Management connects to the information sources through wired ethernet connections which are part of the customer's infrastructure and acquires patient data from primary medical device sources and clinical systems. TigerConnect implementation engineers configure TC Alarm Management, in collaboration with the customer, to determine which information, including alarm notifications, is delivered to which users. TC Alarm Management then formats the data for wireless delivery to the endpoint devices through TigerConnect's proprietary Clinical Collaboration Platform (CCP) non-regulated MDDS messaging service.

TC Alarm Management is designed to accept inputs from a variety of healthcare systems utilizing the HL7 Minimum Lower Layer Protocol (MLLP) communication protocol. These clinical systems include the following:

• Medical device gateways providing HL7 MLLP communications, which includes, but is not limited to, the following parameters and events surrounding them, e.g. alarms:
  • Patient monitors such as electrocardiograms (ECGs), respiratory rate, pulse oximetry (SpO2 and heart rate), end-tidal carbon dioxide (EtCO2), non-invasive blood pressure, cardiac output, temperature and associated derived outputs.
  • Lung ventilators.
  • Respiratory gas monitors.
  • IV infusion (including patient-controlled analgesia) pumps.
• Nurse call systems.
• Electronic health record (EHRs) systems.

TC Alarm Management provides a wireless communications system platform for delivery of secondary notifications to endpoint devices with Android or iOS operating systems (OSs) through the CCP messaging service.

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