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510(k) Data Aggregation
K Number
K040663Device Name
TELENABLE EMS SYSTEM
Manufacturer
Date Cleared
2004-06-30
(110 days)
Product Code
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
MOLEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TelEnable EMS System provides a mechanism to transmit 12-lead ECGs from a portable ECG monitor to a central location such as a hospital. This system connects to the ECG via a standard POTS (Plain Old Telephone System) interface and communicates to the ECG via standard Group 3 facsimile (fax) protocol.
Device Description
The TelEnable EMS System provides a means of transmitting snapshots of physiologic waveforms and data over standard communications means such as the public switched telephone, analog cellular, or digital cellular networks. Such information is transmitted from a remote location using the EMS-Enable component to a receiving EMS Hub component located in a hospital.
The EMS-Enable component connects to portable ECG & standard monitor/defibrillator devices that can output their data via a standard fax modulator (modem). The EMS-Enable decodes the touch tone dialing digits output by the monitor to determine which hospital to call. This analog information is converted into encrypted data packets that are suitable for transmission over digital and analog networks. The EMS-Enable is a self-contained, battery-powered device that is connected to a cell phone via a standard data cable compatible with the phone and a standard telephone adapter cable.
Standard fax output from the ECG monitor/defibrillator device is received by the EMS-Enable (as if was a standard telephone wall plug). The data is encrypted and converted into data packets to be transmitted over the digital cellular or other standard communication network. The EMS-Enable transmits the data packets over the communication network to the EMS Hub where the ECG fax can be printed out on a standard printer, saved in a data file, or printed out on a standard fax machine.
The EMS Hub component is located in the hospital and provides the interface between the remote EMS-Enable devices and the hospital. It is connected to the Public Switched Telephone Network (PSTN or standard telephone network) via standard telephone patch cables. It communicates with the EMS-Enable and depacketizes and decrypts the ECG fax into a format compatible with a printer, file, or standard fax machine.
The transmission formats supported by the EMS-Enable and EMS Hub include standard group 3 fax modulation formats, touch-tone signaling (DTMF), and standard interface protocols and schemes utilized by cell phones and cell phone carriers to transmit data.
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