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The LifeSignals WiPatch & WiApp system is intended for spot check and short-term monitoring of ECG & heart rate of patients at rest or patients who can be transported within the range of the antenna network. The WiPatch & WiApp system has visual and audio alarms to alert clinical personnel when heart rate falls outside the set limits. The device is intended for use on general care patients of 18 years or older. The device is not intended for use on critical care patients. The LifeSignals WiPatch & WiApp System is contraindicated for use on patients with active implantable medical devices such as pacemakers, implanted cardioverter defibrillator (ICD) & left ventricular assist devices (LVAD); for use in a magnetic resonance (MR) environment; for use during surgical procedures when electro-surgical equipment is operational.

The LifeSignals WiPatch & WiApp System consists of the 1) LifeSignals WiPatch 2) LifeSignals WiApp System and 3) Access Point as described below. The LifeSignals WiPatch: - is a wireless ECG patch that--when attached to the upper left chest of a patient -continuously acquires physiological signals and transmits these signals wirelessly to any compatible receiver. - is disposable and integrated with four adhesive electrodes for body interface. - acquires two channels of electrocardiograph (ECG-A and ECG-B) signals - transmits acquired signals after initial pre-processing to a compatible receiver wirelessly using the 802.11b communication protocol (2.4 GHz). - is powered by two-coin cell batteries (zinc air) with an operating life up to 72 hours. - has an integrated switch to power it on, and has bi-color LED indicators to indicate the communication status with the receiver. The LifeSignals WiApp System: - consists of a LifeSignals WiApp Software App (WiApp SW), and a compatible commercial iOS device (iPad, iPad 2, iPad Air or iPad Air 2) - software, when installed on a compatible hardware, establishes a connection to any one of the LifeSignals WiPatches connected to the same wireless network/Access Point through a pairing process. - receives the transmitted signals from the paired WiPatch wirelessly, processes the signals and displays heart rate, ECG (ECG-A and ECG-B) waveforms on its LCD display for monitoring purposes by trained clinical personnel. - has audio and visual alarms to alert clinical personnel when heart rate of a patient is outside the set limits, lead off, when the battery is low (either the WiPatch or the WiApp System - iPad), or when there is a loss of communication link between the WiApp System and the WiPatch. Access Point: An access point is a commercially available hardware device (a.k.a wireless router) that allows wireless capable devices connect through a wireless standard (e.g. 802.11b). LifeSignals WiPatch and WiApp system communicate through an access point.

The HMicro Wired C-Patch ECG Electrode is a single patient use, disposable, radiolucent wired ECG electrode with a silver/silver chloride sensing element designed for short-term, adult ECG monitoring at rest. It is designed to provide a single patch alternative to distributed electrodes. It has been tested using the GE Marquette Eagle 4000 ECG monitor and patient cable and should be used with monitors with equivalent or better sensitivity. The HMicro, Inc. Wired C-Patch is indicated for ECG monitoring of adults at rest when the upper left chest or center chest is available to place the patch.

The HMicro Wired C-Patch Electrode is a single 3-inch patch electrode designed to be placed on the left upper chest or center chest and used for ECG monitoring. It is disposable and single use. It has five pre-wired electrodes affixed to a 3-inch silicone patch, where wires from the electrodes are pulled through the silicone patch for connecting into the patient monitoring cable.