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Tyco Electronics Electrocardiograph (ECG) Leadwire Sets are indicated for use in the monitoring of cardiac signals for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment.

Tyco Electronics Electrocardiograph (ECG) Leadwire Sets are intended for use with ECG monitors manufactured by Philips Medical Systems. Both the Philips and the Tyco Electronics groups of leadwire sets are designed specifically for compatibility with Philips ECG monitors and consist of insulated copper conductors with connectors on each cable end. The term leadwire set includes ECG leadwires as well as the attached proximal and distal connectors. Leadwire sets are used to transfer signals originating from skin-mounted ECG electrodes (distal end) to a patient monitoring device (proximal end). Tyco Electronics ECG Leadwire Sets are single-use devices within the meaning of that term as used by FDA - that is, they cannot be reprocessed and re-used. As described by FDA, a single-use device, also referred to as a disposable device, is not intended to be reprocessed (cleaned, disinfected/sterilized) and used on another patient. All leadwire sets addressed within this 510(k) submission are produced in a configuration that is shielded against electromagnetic interference; they are single-use devices, not sterilizable and not reusable, intended for short-term use only (recommended use duration 7 days or less).