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The LifeBed Network Patient Vigilance System is intended for use with adult patients by health care professionals in the continuous measurement of heart rate, respiratory rate, and as an integral part of fall prevention protocols.

The LifeBed Network Patient Vigilance System ("LifeBed Network") is composed of a bedside unit (either a LifeBed Display or Vigilance Display, generically referred to as a Display), a sensor array packaged in the form of a mattress coverlet, and the LifeBed Controller. The LifeBed Displays are optionally equipped with a wireless adapter. The LifeBed Network Patient Vigilance System collects, stores, and reports patient medical and status information. Each Display is a bedside unit that collects and processes data from a sensor array on the patients' bed. It reports patient heart rate, respiratory rate, whether the patient is in bed, and any alerts. The configuration of a Display may be changed on the Display or remotely from the LifeBed Network. The Displays are connected to the LifeBed Controller via a TCP/IP network which is provided by the customer. This network may be wired (using Ethernet), or wireless (using WiFi) as required by the facility. The hub of the LifeBed Network is the LifeBed Controller'), which serves one unit (e.g., a hospital ward). From the Controller a user has access to the collected information and the ability to view and modify the configuration of connected Displays. The LifeBed Network provides an interface which may be used to integrate with a Clinical Information System (CIS). When used in this way an auxiliary adapter isolates and translates the protocols between the LifeBed Network and the CIS. This interface allows the collected data and stored configuration for the Displays. The LifeBed Network centralizes information access and configuration for a group of Displays. It DOES NOT change the manner in which alerts are communicated by the Display to the Nurse Call system of the hospital. All user access to the LifeBed Network is constrained by a security system. Each user is authenticated by a user name and password and their ability to access data is controlled by their assigned role.

The LifeGurney™ Network Patient Vigilance System is intended for use with adult patients by health care professionals in the continuous measurement of heart rate, respiratory rate, and as an integral part of fall prevention protocols.

The Vigilance Display is a modification of the LifeBed Display previously submitted and cleared as K083534. The Vigilance Display differs from the Lifebed Display in that it has additional enclosures attached which contain batteries, a battery controller, an auxiliary nurse call system, and a wireless adapter. The battery and controller are attached to the Display, the auxiliary nurse call system and wireless adapter are attached to the top. User interaction is the same as on the LifeBed Display—the front panel keypad (hidden behind a door in the above photos) is used to change settings and mark events in the log. The large button on the front of the Display is used to acknowledge events. The software for the same as in the predicate system. The nurse call connector and the Display power switch are located under a hatch on the right side of the Display (as viewed from the front). The Display power switch controls the power from the batteries to the Display. The AC power connection is on the side of the battery and controller enclosure. Above the AC power connection is the main power switch. This switch controls the AC power to the battery controller. When the switch is on and an AC power source is connected the batteries are charging. When the switch is off or no AC power source is connected, then power is drawn from the batteries. On the opposite side are the slots for the removable batteries. These batteries are typically installed in pairs, but only one is required to operate the system (with reduced run time). An optional external battery charger and spare batteries are available, enabling the operation of the system in areas where AC power is not available or is difficult to use. The coverlet is the component that provides the interface between the patient and the Vigilance Display unit. It contains the sensors, wiring, and electronics necessary to measure the patient's heart rate, respiration rate, and bed presence and transmit signals to the Vigilance Display. The LifeGurney Network Patient Vigilance System is compatible with and uses the same series of coverlets as the LifeBed Network Patient Vigilance System. Gurney specific coverlets will be sized to fit specific gurney mattresses. The coverlet contains the sensing elements and interface electronics for connecting the coverlet to the Display with a coverlet cable. The sensing elements and electronics are separated from the patient by a layer of coated fabric; there is no contact between the patient and the sensors. Additional separation of the sensors is provided by the bed sheets, pads, and the patients' garments. The coverlet encases the existing mattress. The coverlet contains all necessary conductors to carry sensor signals within the coverlet.

The LifeBed Network Patient Vigilance System is intended to measure heart rate, respiratory rate, and bed exit in adult patients for use by health care professionals.

The LifeBed Network Patient Vigilance System is identical to the LifeBed Patient Vigilance System described in the LifeBed Patient Vigilance System, K082366 with three exceptions. A Controller as been added which will not be in the patient vicinity, A wireless adapter has been added, and the Indications for Use have been reworded. The LifeBed Network integrates with the LifeBed Display to collect, store and report patient medical and status information. The Display can be configured from the Network or from the Display. The Network and Display are connected using TCP/IP protocols. To ease logistical considerations at the installation site, these two components are usually bridged across a wireless network using a LifeBed Wireless Adapter. The Network also provides an interface which may be used to integrate with a clinical information system (CIS). When used in this way, an adapter box isolates and translates protocols between the Network and the CIS. The Network centralizes information access and configuration for a group of Displays. It DOES NOT change the manner in which alerts are sent through the Nurse Call system of the hospital. Each Display is a bedside unit that collects and processes data from a sensor array on the patients' bed. It reports patient heart rate, respiration rate, alarm and if the patient is in bed or out of bed to the Controller. This information is NOT displayed real time and is NOT to be used as a method to monitor the patient. The hub of the Network is the LifeBed Controller which serves one unit (e.g., a hospital ward). From the Controller the user has full access to the information gathered from the unit and configuration of all of the Displays in the unit. The Controller also provides the interface used to integrate into a CIS or with a future product. All user access to the Network is constrained by a security system. There are two factors involved: the individual user's role and the specific access permissions assigned to the user. The user's role constrains the type of data the user has access to (e.g. medical, device status, etc.). By default, all users have specific access to information sourced by their organization. Permission to access data sourced by another organization is denied unless specifically allowed. The Network operates in a medical setting and must comply with relevant regulatory agency and legal requirements. As a medical product the Network must protect patient privacy. It must comply with all the requirements of the HIPAA Act.

The LifeBed Patient Vigilance System is intended to measure heart rate and respiratory rate in adult patients, in bed, in a general care hospital environment. The system will also monitor bed exit.

The LifeBed Patient Vigilance System consists of two (2) main components: the bedside unit and the Passive Sensor Array™ (PSA™). The bedside unit houses the digital signal processing algorithms that calculate heart and respiratory rates and bed exit status (in-bed sensor) in real time and displays the data as part of the integrated graphical user interface. The bedside unit houses the alarm logic and interfaces to the existing nurse call system found in the hospital. The PSA is comprised of a mattress ticking ("coverlet" that slips over the entire mattress) that houses an array of sensors, which connect to the bedside unit via a cable with an integrated "quick disconnect" safety feature. The LifeBed Patient Vigilance System's Passive Sensor Array (PSA) technology analyzes basic heart and respiratory physiology without direct patient contact, eliminating the use of electrodes, wires and leads. Hoana's PSA technology integrates proprietary signal processing algorithms with patented data collection devices that produce an electrical signal in response to physiological stimuli. The LifeBed Patient Vigilance System passively extracts patient measurements even through clothing, gowns or sheets.

The LG TM Intelligent Medical Vigilance System is intended to measure heart rate and respiratory rate in adult patients, in a general care hospital environment. The system will also monitor bed exit.

The [G] system consists of two main components: the Bedside Unit, and the Passive Sensor Array™ (PSA™). The Bedside Unit houses the digital signal processing algorithms ([G1 algorithms, version 1.0.0.36) that calculate heart and respiratory rates and bed exit status (in-bed sensor) in real time, and displays the data as part of the integrated graphical user interface. The Bedside Unibilary houses the alarm logic, and interfaces to the existing nurse call system found in the hospital. The PSA is comprised of a mattress ticking ("coverlet" that zips over the entire mattress) that houses an array of sensors, which connect to the Bedside Unit via a cable with an integrated "quick disconnect" safety feature.