Abstract: The ECG leadwire connector is designed in a way that allows low cost high volume manufacturing of an ECG leadwire assembly using standard continuous web converting processes and materials. The integrated ECG leadwire connector is assembled using the same printing and laminating processes that are used to construct the rest of the leadwire assembly. Patient safety requirements are met by the physical dimensions of the connector electrical contacts and by the thickness of a dielectric isolation feature which prevents inadvertent contact with potentially hazardous potentials, while still allowing the connector pins to make contact with the leadwire conductors. The connector also incorporates and RFID tag that allows multiple leadwire configurations to be accommodated and identified and authenticated during use.

Abstract: Devices and methods comprise or provide an ECG recording device containing a mailable base and electrode assembly and/or other means engageable with the base to receive ECG signals from a subject during a self-administered ECG examination. The devices and methods may also include a single-use or limited-use ECG recording device, in which the base is disposable or reusable or recyclable. In addition, the device may be self-contained, battery-operated, portable, disposable, mailable to a location remote from an ECG examination, provide feedback, indicate its method of use, including graphically depicting same, contain a finger cuff and/or sensor pad for receiving ECG signals, and/or contain a memory. Preferably, the base conforms to various body shapes and/or sizes, is made of flexible and/or semi-flexible material, and/or contains a receptor, such as sealable blood well.

Abstract: A method for configuring monitoring devices in a clinical study is disclosed herein. The method includes inputting configuration data into a configuration apparatus, providing a plurality of patient monitoring devices adapted for use in a clinical study, and connecting each of the plurality of patient monitoring devices to the configuration apparatus. The method also includes automatically transmitting the configuration data from the configuration apparatus to each of the plurality of patient monitoring devices such that each of the plurality of patient monitoring devices is generally identically configured in a manner that minimizes labor requirements.

Abstract: An electrode set is disclosed herein. The electrode set includes a base comprising an insulating material, and a plurality of electrodes disposed on the base. The electrodes comprise a generally exposed conductive material. The electrode set also includes a plurality of conductors disposed on the base. The conductors comprise a generally insulated conductive material, and are each connected to one of the electrodes. The electrodes are positioned on the base relative to each other so that they can be collectively placed on specific portions of a patient's anatomy.

Abstract: Devices and methods comprise or provide an ECG recording device containing a mailable base and electrode assembly and/or other means engageable with the base to receive ECG signals from a subject during a self-administered ECG examination. The devices and methods may also include a single-use or limited-use ECG recording device, in which the base is disposable or reusable or recyclable. In addition, the device may be self-contained, battery-operated, portable, disposable, mailable to a location remote from an ECG examination, provide feedback, indicate its method of use, including graphically depicting same, contain a finger cuff and/or sensor pad for receiving ECG signals, and/or contain a memory. Preferably, the base conforms to various body shapes and/or sizes, is made of flexible and/or semi-flexible material, and/or contains a receptor, such as sealable blood well.