Defibrillators - Option 1

The designated position includes the following medical devices: 1. Cardioverter defibrillator - type 1 with the following minimum technical requirements - Cardioverter defibrillator for monitoring and regulating patient heart rate and single-chamber sensing and pacing for bradycardia. The device should be suitable for MRI scanning at 1.5T field strength, hermetically sealed, with small dimensions – 71 x 40 x 14 mm. It should have an overcurrent detection algorithm that automatically changes shock configurations, Decision Tx programming technology designed to reduce inappropriate therapy, an electrode noise separation function that detects sustained and short bursts. It should have functions that improve SVT and VT discrimination to reduce inappropriate therapies. It should have a low-pass filter designed to aid sensing and reduce the possibility of T-wave oversensing, a shock safety option at 40J delivered energy and be able to provide a higher level of DFT safety. 2. Single-chamber cardioverter defibrillator with the following minimum technical requirements - Single-chamber cardioverter defibrillator with Bluetooth Low Energy data communication, allowing connection to a smartphone via data encryption with DF-4 connector. The device is suitable for full-body MRI scanning at 1.5T or 3T, electrically active titanium casing, with small dimensions – 63 x 51 x 12 mm. Algorithm for automatic adjustment of sensitivity control for ventricular events, Decision Tx programming technology designed to reduce inappropriate therapy, RV lead noise detection. It has functions that improve SVT and VT discrimination to reduce inappropriate therapies. The overcurrent detection algorithm automatically changes shock configurations to ensure high-voltage therapy delivery at high current. 3. Cardioverter defibrillator - type 2 with the following minimum technical requirements - Cardioverter defibrillator for monitoring and regulating patient heart rate and single-chamber sensing and pacing for bradycardia. The device should be suitable for MRI scanning at 1.5T field strength, hermetically sealed, with small dimensions – 71 x 40 x 14 mm. It should have an overcurrent detection algorithm that automatically changes shock configurations, Decision Tx programming technology designed to reduce inappropriate therapy, an electrode noise separation function that detects sustained and short bursts. It should have functions that improve SVT and VT discrimination to reduce inappropriate therapies. It should have a low-pass filter designed to aid sensing and reduce the possibility of T-wave oversensing, a shock safety option at 40J delivered energy and be able to provide a higher level of DFT safety. QHR chemical batteries should provide higher capacity for extended battery life. + Separating electrode with active fixation one or two coils. The electrode is designed for implantation with the distal tip in the right ventricle and provides sensing, pacing, and shock therapy via a cardioverter defibrillator. The tip design aids visualization under fluoroscopy. Part of the electrode is covered with Optim insulation. The electrode has various connectors. - estimated quantity 4 pcs. 4. Dual-chamber cardioverter defibrillator with the following minimum technical requirements - Dual-chamber cardioverter defibrillator with Bluetooth Low Energy communication, allowing connection to a smartphone via data encryption with DF-4 connector. The device is suitable for full-body MRI scanning at 1.5T or 3T, electrically active titanium casing, with small dimensions – 69 x 51 x 12 mm. Algorithm for automatic adjustment of sensitivity control for ventricular events, Decision Tx programming technology designed to reduce inappropriate therapy, noise detection...