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The base is intended to be used as part of the CareLink SmartSync device manager system. Clinicians use the base to analyze the electrical performance of cardiac leads during device implant or invasive troubleshooting. Clinicians use the base's ECG connections along with the app display to view, measure, and record live cardiac waveforms. The base is intended to be used by healthcare professionals only in operating environments under direct medical supervision.

The CareLink SmartSync Device Manager system is comprised of the Model 24970A Base and CareLink SmartSync Device Manager app installed and running on your mobile device. The Base pairs with the app on your mobile device to analyze the cardiac lead system for an implantable Medtronic device. The base includes analyzer hardware and patient cable connections, ECG cable connections, and Bluetooth wireless technology. The Base contains a microprocessor that maintains the pacing engine logic function. The PSA hardware within the Base consists of two main integrated circuits (ICs): a Micro Controller Unit and a Mixed Signal Integrated Circuit. The App is the primary user interface and includes a Host Application, a Platform Application, a Common Application, and a PSA Application component. The Analyzer tools in the App display and report on the cardiac lead and ECG data transmitted from the base.

The Merlin PSA Patient Cable EX3150 is a three-channel resterilizable patient cable intended to connect the Merlin PSA to as many as three IS-1 leads or to SJ4 leads. The Merlin PSA Patient Cable Adapter EX3170 is a three-channel adapter intended to connect the Merlin PSA to as many as three disposable patient cables. The EX3170 Cable Adapter can connect to the Models 4051/4051A disposable patient cables for IS-1 leads or to the Model 4161 disposable patient cable for SJ4 leads. The opposite ends of the disposable patient cables connect to implantable pacing leads. The Merlin PSA "M" Adapter Model EX3180 is intended to connect the Merlin PSA to the twochannel Medtronic Model 2292 re-sterilizable patient cable. The opposite end of the Medtronic Model 2292 cable connects to implantable pacing leads. Following use, the patient cables must either be disposed or re-sterilized, depending on the requirements of the cable.

The Merlin PSA Patient cable, Model EX3150 is an accessory to the Merlin PSA EX3100 system, which is intended to assess the pacing and sensing performance of the lead system prior to pulse generator implantation, or during invasive lead system troubleshooting. The PSA Patient cable is intended to connect one to three implanted leads to the Merlin PSA EX3100, which is the patient interface part of the PSA product. The PSA Patient cable is the interface between the implanted leads and the PSA unit. The ODU connector end of the cable is connected to the Merlin PSA and the Alligator clip end is connected to the leads. The PSA Patient cable is re-sterilizable. Patient Cable Adapters - Merlin PSA Cable Adapter EX 3170, Merlin PSA "M" Adapter EX 3180 connects the Merlin PSA to commonly used PSA patient cables Merlin PSA Cable Adapter EX3170 connects to the currently marketed disposable surgical cables 4051/4051A and 4161. Merlin PSA "M" Adapter EX3180 connects to the Medtronic Model 2292 patient cable.

The ERA 300 is intended for use during invasive pacemaker procedures in the following activities: . Temporary External Pacing Provides temporary stimulation under DDD, DDI, DOO, VVI, VDD, VOO, AAI, or AOO modalities 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, sensitivity, refractory period, A/V delay, and rate/interval.

The ERA 300 is a portable, dual chamber pacing system analyzer designed to test the electrical performance of the pulse generator and the pacing lead system or operate as a temporary external pulse generator at the time of pacemaker implantation and during invasive pacemaker troubleshooting or evaluation procedures. The ERA 300 utilizes a touch-proof configuration to help prevent hazardous connection between patients and electrical power sources.

The Model 6149 Pacing Vector Selector Cable Switch is a manually operated unit used during lead implants for PSA measurements and provides the capability to switch RV and LV tip and ring signals to five possible electrode combinations.

The Model 6149 Pacing Vector Selector Cable Switch was designed to interface between the Guidant Model 3105 or 3106 Pacing System Analyzer and Guidant 6697 Patient Cables. It is manually operated and has no active circuits or power sources. It is a 3-channel Patient Adapter Cable, easily switchable between PSA vector measurements on implanted leads without relocating alligator clips on the lead terminal. A 2-pole, 5 position switch is integrated into the 3-channel molded connector housing on the distal end of the cable. The pacing vectors options provided are: Left Ventricle Tip to Right Ventricle Coil, Left Ventricle Ring to Right Ventricle Coil, Left Ventricle Ring to Left Ventricle Tip, Left Ventricle Tip to Left Ventricle Ring, Right Ventricle Tip to Right Ventricle Coil.

The ERA 300 is intended for use during invasive pacemaker procedures in the following activities: - Temporary External Pacing Provides temporary stimulation under DDD, DDI, DOO, VVI, VDD, AAI, or AOO modalities 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. Deternines the following parameters: pulse and width, sensitivity, refractory period, AV delay, and rate/interval.

The ERA 300 is a portable, dual chamber pacing system analyzer designed to test the electrical performance of the pulse generator and the pacing lead system or operate as a temporary external pulse generator at the time of pacemaker implantation and during invasive pacemaker troubleshooting or evaluation procedures. The ERA 300 utilizes a touch-proof configuration to help prevent hazardous connection between patients and electrical power sources.

The ERA 3000 is intended for use during invasive pacemaker procedures in the following activities: - Temporary External Pacing Provides temporary stimulation under DDD, DDI, DOO, VVI, VDD, AAI, A00, or ODO modalities 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, A/V delay, and rate/interval.

The ERA 3000 is a portable, dual chamber pacing system analyzer designed to test the electrical performance of the pulse generator and the pacing lead system at the time of pacemaker implantation and during invasive pacemaker troubleshooting or evaluation procedures. It can also operate as a temporary external pulse generator during the above mentioned procedures. The ERA 3000 utilizes a touch-proof confiquration to help prevent hazardous connection between patients and electrical power sources.