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Catalog excerpts

VISIA AF™ VR Model DVAB1D4 - 1

Product specifications Physical characteristics Volumea Surface area of device can 57 cm2 Radiopaque IDb Materials in contact with human tissuec Titanium, polyurethane, silicone rubber Battery chemistry Hybrid CFx lithium/silver vanadium oxide Volume with connector ports unplugged. b 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 energya,b Maximum stored energyc Typical charge time at Beginning of Service (BOS)d Typical charge time 12.5 s at Recommended Replacement Time (RRT)d a 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 § PhysioCurve™ Design § SmartShock™ 2.0 Technology § OptiVol™ 2.0 Fluid Status Monitoring § Complete Capture Manage

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VISIA AF™ VR Model DVAB1D4 - 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 ; Episiodes ≥ 10 min; Episodes ≥ 20 min; Episodes ≥ 30 min; Episodes ≥ 60 min Programmable values 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...

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VISIA AF™ VR Model DVAB1D4 - 3

Ventricular tachyarrhythmia therapy parameters, cont. Programmable values Programmable values Smart Mode Ramp therapy parameters … 15 Initial # Pulses Smart Modeb Ramp+ therapy parameters Initial # Pulses Smart Modeb V-V Minimum ATP Interval V. Amplitude Active Can™/SVC Coilc Progressive Episode Therapies Programmable values RV Amplitude Safety Margin RV Minimum Adapted Amplitude RV Acute Phase Remaining Rate response pacing parameters Programmable values The corresponding Lower Rate Interval can be calculated as follows: Lower Rate Interval (ms) = 60,000/Lower Rate. Upper Sensor Rate Rate...

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VISIA AF™ VR Model DVAB1D4 - 4

Conducted AF response parameters Parameter Programmable values Conducted AF Response Maximum Rate Shared (Device Tone and Patient Home Monitor) Parameter V. Rate Stabilization Maximum Rate Interval Increment Daily Burden for Avg. V. Rate Programmable values Ventricular rate stabilization parameters Number of Shocks Delivered in an Episodec … 120 bpm Device Tone Alert Enable – Urgency Patient Home Monitor Post VT/VF shock pacing parameters Parameter Avg. V. Rate During AF Alert Enablec Response Level AF Daily Burden Alert Enablec Alert Enablec Programmable values Shared (Device Tone and...

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VISIA AF™ VR Model DVAB1D4 - 5

Data collection parameters Lead/Device integrity alerts, cont. Parameter Programmable values Data collection parameters Patient Home Monitor Programmable values LECG Source (Leadless ECG)a Can to SVCb; Can to RVcoil RVcoil to SVCb RV Defibrillation Impedance Enablec LECG Range (Leadless ECG) SVC Defibrillation Impedance Enableb,c RVtip to RVcoil; RVtip to RVring Can to RVcoil ; Can to RVring; RVtip to RVcoil; RVtip to RVring; Can to SVCb,d; RVcoil to SVCb RVtip to RVcoil; RVtip to RVring Stored (Ventricular) EGM1 and EGM2 ; EGM1 and EGM3; EGM1 and LECG; EGM2 and EGM3; EGM2 and LECG; EGM3...

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VISIA AF™ VR Model DVAB1D4 - 6

System test parameters, cont. Manual defibrillation parameters Selectable values AX>B; B>AX Selectable values Wavelet Test parameters … 97 Match Threshold Lower Rate The selectable values for this parameter depend on the programmed pacing mode. 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. Manual cardioversion parameters T-Shock induction parameters Selectable...

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VISIA AF™ VR Model DVAB1D4 - 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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