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The PSA cable is an accessory indicated for use with external PSA equipment distributed by Boston Scientific and is used for the transmission of sensing signals and pacing pulses for evaluation of lead placement characteristics during implant of pacemakers and defibrillators and for the support of other pacemaker functionality.

The Pacing System Analyzer (PSA) cable, Model 6763, is an external cable used to transmit signals to and from a connected PSA device. The connected PSA equipment is used during the implantation of pacemakers and defibrillators to evaluate the placement and integrity of leads and to determine the appropriate pacing parameters for the implanted device. The PSA cable leadwires are affixed to the implanted lead while the other end of the cable, the trunk cable, is plugged into the external PSA device. The PSA cable is used with the BSC distributed PSA devices.

The PK-141 patient cable is an accessory indicated for use with external equipment from BIOTRONIK and is used for the transmission of sensing signals and pacing pulses for diagnostics and therapy in the context of intracardiac examinations including the following activities: - Temporary External Pacing Provides temporary stimulation during implantable pacemaker procedures or physician evaluations. - Lead Threshold Determination Determines in situ lead characteristics of impedance, capture threshold. P/R wave amplitude and P/R wave slew rate. Determines the in vivo retrograde conduction time. - Pacemaker Function Test Tests and analyzes the in vitro operation of external or implantable pulse generators. Determines the following parameters: pulse amplitude and width, AV delay, and rate/interval.

The PK-141 patient cable is compatible with the following BIOTRONIK external equipment: ICS 3000 Implant Control System, EDP 20/30 B External Pacemakers, and ERA 300/3000 Pacing System Analyzers. The PK-141 is intended to connect to the patient's sensing and pacing leads. The PK-141 is connected to the Redel connector provided by the external equipment and the alligator clips connect to the electrode. The PK-141 is made up of a 2.8m cable with four touch-proof alligator clips. The alligator clips are clamped directly to the tip or the contact ring of the leads. During its use, the cable is in the sterile field; therefore it must be sterile itself. Skin contact with the patient is not anticipated.

The SigmaPace 1000 External Pacemaker Analyzer is intended for use as regular preventative maintenance and quality assurance checks on external cardiac pacemakers in both the pre-hospital and hospital based environments. The SigmaPace 1000 is limited to preventative maintenance checks for transcutaneous and transvenous types of temporary external cardiac pacemakers. The SigmaPace 1000 will perform a full range of specific testing procedures and protocols developed by the external cardiac pacemaker manufacturers. The SigmaPace 1000 will also provide ECG simulation capabilities for applications in clinical training and product demonstration. The SigmaPace 1000 is intended to be used by biomedical technicians, OEM manufacturers, and third party service facilities to perform preventative maintenance and quality assurance checks on external cardiac pacemakers, to verify the operation of devices returned from repair, and to assist repair facilities in the diagnosis of intermittent performance problems. The SigmaPace 1000 is also intended to be used by training facilities to train medical personnel. The SigmaPace 1000 is not used on patients and does not perform any diagnostic, therapeutic, or monitoring functions. Additionally, these devices are not used to test any programmable, implantable pacemakers or any related indwelling cardiovascular catheters or lead wires.

The SigmaPace 1000 is a device used to verify the performance of various parameters of external cardiac pacemakers. This is done by connecting the external leads of the pacemaker to test inputs on the SigmaPace 1000 and selecting the pacemaker to test or by using the press buttons on the front panel display or via appropriate test cables by serial port (RS232). The SigmaPace 1000 can perform a variety of Transcutaneous and Transvenous (Atrial and Ventricular) Pacer tests. Pulse current, rate, width, and energy Qualitative demand and async mode tests Amplitude sensitivity tests Noise immunity tests Paced and Sensed Refractory tests Selectable model specific transcutaneous algorithms Selectable test loads DC leakage current (tranvenous) Current drain test (transvenous) Long term test for pacer output stability ECG simulation for training activities