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The Affinity Medical Patient Cable Systems are intended to transmit data in the form of electrocardiographic signals from patient ECG electrode pads to ECG monitors.

The Affinity Cable and Leadwire System includes ECG cables, individual leadwires, and accessories. The Affinity Cable and Leadwire System is based upon proven designs to assure secure connections for patient safety and operator ease of use. The Affinity Cable and Leadwire System is reusable and is designed and tested to conform to the following standards: ANSI/AAMI EC53-1995 and 21 CFR Part 898. The Affinity Cable and Leadwire System is manufactured of materials with a proven history of use for ECG cables. The Affinity Cable and Leadwire System contains no latex or latex products which are external and exposed to the patient. The Affinity Cable and Leadwire System is provided non-sterile. The Affinity Cable and Leadwire System is designed to minimize the potential for incorrect attachments. Leadwires are color coded for positive identification. Leadwire connectors include recessed sockets to preclude attachment to power cables or outlets.