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The indications for use of the VitalCom Networked Monitoring™ system (VCOM, IRVS/RVS) are: Monitoring of Recognized Conditions An environmentally controlled clinical settings that has multiple patients using any combination of ECG leads, bedside monitors or Nellcor Puritan Bennett (NPB) 7200 series ventilators. Hospital areas that have the capability of installing hardwire paths to the VitalCom's Central Monitoring Station (VCOM) from the rooms or areas where bedside monitors or NPB 7200 series ventilators operate. Clinical areas that have the capability of installing 174-216 MHz radio systems (or alternate frequency bands approved by the FCC) to communicate via RF. The information from the ECG leads, bedside monitors or NPB 7200 series ventilators is transferred via an RF transmitter to the Central Monitoring Station (VCOM), The Target Population Those patients who are connected through the VitalCom Networked Monitoring™ system via ambulatory ECG transmitters, bedside monitors or NPB 7200 series ventilators. Important Limitations Each VitalCom Network Monitoring™ system can monitor up to a maximum of 10 patients per Central Monitoring Station (VCOM) and 200 patients per VitalCom Networked Monitoring™ system. The VitalCom Central Monitoring Station (VCOM) is to be installed at the point of care locations that have the capability of installing hardwire paths to a VCOM from rooms or areas where bedside monitors or NPB 7200 series ventilators operate. If employing wide area networking technology, the communication between the VCOM, at the point of care location, and the IRVS/RVS, at the supplementary care location, is facilitated by dedicated telephone lines and commercially available interface hardware. The VitalCom Networked Monitoring™ system is not for use in the home. The Central Monitoring Station (VCOM), is only used at the point of care location and is capable of operating independently of any IRVS/RVS connections.

The typical VCOM monitors up to ten patients using either ambulatory ECG transmitters (V-Pak) or radio transmitters (V-Link) connected to bedside monitors or ventilators. The VitalCom Networked Monitoring™ system may include interactive remote viewing stations (IRVS), and remote viewing stations (RVS) or VCOMs linked using the VitalCom wide area network (WAN) technology (Site-Link). As with the predicate device, multiple central stations (VCOM Hubs) maybe used in the clinical setting and connected via a local area network (LAN).