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VISIA AF MRI™ VR SURESCAN™ Model DVFB1D4
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Catalog excerpts

VISIA AF MRI™ VR SURESCAN™ Model DVFB1D4 - 1

VISIA AF MRI™ VR SURESCAN™ Model DVFB1D4 Product specifications Physical characteristics Volumea Surface area of device can Materials in contact with human tissuec Titanium, polyurethane, silicone rubber Battery chemistry Hybrid CFx lithium/silver vanadium oxide Battery model Volume with connector ports unplugged. The radiopaque ID and Medtronic radiopaque identifier can be viewed in a fluoroscopic image of the device. c These materials have been successfully tested for the ability to avoid biological incompatibility. The device does not produce an injurious temperature in the surrounding tissue during normal operation. a Replacement indicators Recommended Replacement Time (RRT) < 2.73 V on 3 consecutive daily automatic measurements Maximum energy levels and typical full energy charge times Maximum programmed energy Maximum delivered energy Maximum stored energy Typical charge time at Beginning of Service (BOS)d Typical charge time at Recommended Replacement Time (RRT)d Energy delivered at connector block into a 50 Ω load. For 35 J programmed energy, delivered energy exceeds 35 J. Energy stored at charge end on capacitor. d Charge time during a nonwireless telemetry session may be slightly higher. b c § AF Diagnostics § MR Conditional § PhysioCurve™ Design § SmartShock™ 2.0 Technology § OptiVol™ 2.0 Fluid Status Monitoring § Complete Capture Man

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VISIA AF MRI™ VR SURESCAN™ Model DVFB1D4 - 2

Device parameters RV Lead Noise Timeout AF detection parameters Parameter Least Sensitive; Less Sensitive; Balanced Sensitivity ; More Sensitive; Most Sensitive Ectopy Rejection Episodes ≥ 6 min , Episodes ≥ 10 min, Episodes ≥ 20 min, Episodes ≥ 30 min, Episodes ≥ 60 min The measured intervals are truncated to a 10 ms multiple (for example, 457 ms becomes 450 ms). The device uses this truncated interval value when applying the programmed criteria and calculating interval averages. b The Wavelet feature is automatically set to On when VF Detection is set to On. c This setting applies to all...

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VISIA AF MRI™ VR SURESCAN™ Model DVFB1D4 - 3

Ventricular tachyarrhythmia therapy parameters, cont. Programmable values Programmable values Smart Mode Ramp therapy parameters … 15 Initial # Pulses This setting applies to all sensing in this chamber for both tachyarrhythmia detection and bradycardia pacing operations. RV Capture Management parameters Parameter Programmable values Smart Modeb RV Amplitude Safety Margin RV Minimum Adapted Amplitude RV Acute Phase Remaining Ramp+ therapy parameters … 15 Initial # Pulses Smart Modeb V-V Minimum ATP Interval V. Amplitude Active Can™/SVC Coil Programmable values Rate response pacing...

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VISIA AF MRI™ VR SURESCAN™ Model DVFB1D4 - 4

Post VT/VF shock pacing parameters Shared (Device Tone and Patient Home Monitor) Programmable values Post VT/VF Shock Pacing Daily Burden for Avg. V. Rate Overdrive Rate Overdrive Duration Number of Shocks Delivered in an Episoded Device Tone Post shock pacing parameters Parameter Post Shock V. Amplitude Post Shock V. Pulse Width Alert Enable – Urgency Programmable values Alert Enablec Shared (Device Tone and Patient Home Monitor) Number of Shocks Thresholdb Programmable values Sleep Rate Patient Home Monitor Sleep parameters Wake Time All Therapies in a Zone Exhausted for an Episode Device...

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VISIA AF MRI™ VR SURESCAN™ Model DVFB1D4 - 5

Lead/Device integrity alerts, cont. Parameter Programmable values ±1; ±2; ±4; ±8 ; ±12; ±16; ±32 mV Can to RVcoil ; Can to RVring; RVtip to RVcoil; RVtip to RVring; Can to SVCb,d; RVcoil to SVCb Shared (Device Tone and Patient Home Monitor) RV Pacing Impedance Less than RV Pacing Impedance Greater than RV Defibrillation Impedance Less than RVtip to RVcoil ; RVtip to RVring RV Defibrillation Impedance Greater than SVC Defibrillation Impedance Less than SVC Defibrillation Impedance Greater than EGM1 and EGM2 ; EGM1 and EGM3; EGM1 and LECG; EGM2 and EGM3; EGM2 and LECG; EGM3 and LECG Stored...

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VISIA AF MRI™ VR SURESCAN™ Model DVFB1D4 - 6

Manual defibrillation parameters Parameter T-Shock induction parameters Parameter Resume at Deliver Enable #S1 S1S1 Delay Energy Waveform Pathwaya a If the Active Can/SVC Coil parameter is set to Can Off, the Active Can electrode is not used as part of the high-voltage delivery pathway. If the Active Can/SVC Coil parameter is set to SVC Off, the SVC Coil electrode is not used as part of the high-voltage delivery pathway. 50 Hz Burst induction parameters Parameter Resume at Burst Amplitude Pulse Width Fixed Burst induction parameters Parameter Resume at Burst Interval Amplitude Pulse Width...

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VISIA AF MRI™ VR SURESCAN™ Model DVFB1D4 - 7

Longevity Projected service life in years Projected service life in years Pacing Mode, percent pacing Pacing Amplitude The service life projections are based on the following assumptions: • Semi-annual maximum energy charging frequency • 1 hour of in-office wireless telemetry annually • Pre-arrhythmia EGM storage programmed to On for a • Typical shelf storage time before implant 6-month period (two 3-month follow-up intervals), Projected service life estimates are based on accelerated over the entire life of the device battery discharge data and device modeling as specified. • 3 hours of...

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