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The ECG Telemedicine Option for the GEMS Series 4000 Communications Console is indicated for use when it is desired to communicate with distant medical devices in an EMS pre-hospital setting and to acquire and present information, such as single/12lead ECG and physiologic/non-physiologic data, or other physiologic information which has been gathered by these devices.

The EMS Telemedicine Option is an optional element of the GEMS Series 4000 communications console which provides the means for performing telemedicine functions, namely, communicating with and presenting information acquired from distant medical devices. The GEMS Series 4000 communications console is a standard radio/telephony communications console used for voice and data communications. The GEMS Series 4000 communications console, without the EMS Telemetry Option is marketed for non-medical applications. Personal Computer (PC) based, it contains various means to interface to and control communications elements (i.e.; 2-way radio equipment, landline and wireless telephone) as which are commonly used for commercial and public safety (i.e.: police, fire and EMS) communications purposes. With the EMS Telemedicine Option, the console can perform medical functions, such as communicating physiologic information (i.e .: single/12-Lead ECG and physiologic/non-physiologic data) with distant medical devices. The signal processing means employed for this includes: frequency modulation (FM), which is commonly used in EMS ECG telemetry applications; DTMF (touch-tone) signaling, which is commonly used for telecommunications signaling: Frequency Shift Keying (FSK), which is commonly used for data communications; as well as standard digital communications schemes such as modulation/demodulation (modem) communications. It also provides for the display and printing of physiologic information, such as single and 12-Lead ECG, and non-physiologic data, such as EMS Run ID, patient name, time of day, etc. The EMS Telemedicine Option consists of hardware and software elements that are installed into the GEMS Series 4000 communications console. These hardware & software elements convert received information into a digital form compatible with standard PC functions, such as information presentation by a CRT monitor and hardcopy printouts. Signal processing is performed by a printed circuit board (PCB) that plugs into the console's PC Mother Board. The EMS Telemedicine Option's features and functions are similar to those found in this type of equipment, including the predicate devices (GEMS Series 2000 and Rosetta-Rx). The digital and analog technologies employed by the above stated purposes are commonly employed for this purpose and are well understood. The functioning of the heart rate meter and the performance of the demodulator/signal processing and display elements conform to ANSI/AAMI EC11-1991.

The EIM-107 is indicated for use whenever it is desired to measure or assess the impedance and/or offset voltage of surface biopotential electrodes applied to the skin of a patient.

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