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ADVISA DR MRI™ SURESCAN™
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Catalog excerpts

ADVISA DR MRI™ SURESCAN™ - 1

ADVISA DR MRI™ SURESCAN™ A2DR01 Product Specifications MR Conditional Initial Implant Existing Implant Physical characteristics Volumea Digital dual chamber pacemaker with SureScan Technology (OAE-DDDR) Surface area of titanium device can Materials in contact with human tissued Titanium, polyurethane, silicone rubber Lithium silver vanadium oxide with carbon monofluoride Volume with connector holes unplugged. Grommets may protrude slightly beyond the can surface.. c The radiopaque ID, which includes a Medtronic-identifier symbol, can be viewed in a fluoroscopic image of the device. d 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) ≤ 2.83 V on 3 consecutive daily automatic measurements Elective Replacement Indicator (ERI) Longevity Projected service life in years* Pacing 600 Ω pacing 900 Ω pacing impedance impedance

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ADVISA DR MRI™ SURESCAN™ - 2

AAI <=> DDD (MVP® Mode) 50% Atrial, 5% Ventricular VT/VF episode counters The VT/VF episode counters are maintained for the current follow-up session and the previous follow-up session. VT, VT-NS (> 4 beats), Fast A&V, Counts of each type of PVC runs (2-4 beats), PVC singles, VT/VF episode runs of VRS paces, single VRS paces AT/AF episode counters The AT/AF episode counters are maintained for the current follow-up session and the previous follow-up session. % of time AT/AF, average AT/AF time/day, monitored AT/AF episodes, treated AT/AF episodes, AT/AF summary data pace-terminated episodes,...

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ADVISA DR MRI™ SURESCAN™ - 3

Cardiac Compass® trend data Atrial Sensitivityb,c (Bipolar sensing polarity) Programming, interrogation, and remote session events with date and event annotations; AT/AF total minutes or hours per day; ventricular rate during AT/AF; percent pacing per day; average ventricular rate (day and night rates); patient activity; heart rate variability Rate Histograms data Rate histogram data is available only as a printed report. The report shows the distribution of atrial and ventricular rates recorded since the last patient session and in the period before the last session. The histograms show...

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ADVISA DR MRI™ SURESCAN™ - 4

Rhythm Change Time Interval Shared A. ATP A-A Minimum ATP Intervala A. Pacing Amplitude A. Pacing Pulse Width VVI Backup Pacing Rate a 27.5.1 when the sensitivity threshold is programmed to 0.3 mV or higher. When susceptibility to interference in unipolar sensing mode is tested under the conditions specified in CENELEC standard EN 45502-2-1:2003, clause 27.5.1, the device may sense the interference if the sensitivity threshold is programmed to the values below 1.8 mV. The device complies with the requirements of section 27.5.1 when the sensitivity threshold is programmed to 1.8 mV or...

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ADVISA DR MRI™ SURESCAN™ - 5

Conducted AF response parameters Programmable values Response Level Maximum Rate Rate response pacing parameters Ventricular rate stabilization parameters Programmable values Programmable values Upper Sensor Rate Maximum Rate Interval Increment Rate Profile Optimization On ; Off ADL Response Exertion Response Activity Threshold Low; Medium Low ; Medium High; High Rate drop response parameters Parameter Programmable values Rate Drop Response On; Off Drop ; Low Rate; Both Activity Acceleration Detection Type Activity Deceleration Drop Size Drop Rate Detection Window Rate adaptive AV...

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ADVISA DR MRI™ SURESCAN™ - 6

Data collection parameters Data collection parameters The selectable values for this parameter depend on the programmed pacing mode. The selectable values for this parameter depend on the programmed Lower Rate. c When performing the test in DDD mode, the Lower Rate must be less than the programmed Upper Tracking Rate. b Programmable values Can to RVring; Can to Aring; RVtip to RVring; Atip to RVring; Atip to Aring ; Aring to RVring; RVtip to Can; Atip to Can Selectable values Enabled ; Disabled Can to RVring; RVtip to RVring ; RVtip to Can Pulse Width Can to RVring ; Can to Aring; RVtip to...

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ADVISA DR MRI™ SURESCAN™ - 7

Shared manual ATP therapy parameters Parameter Minimum Interval (ventricular ATP) Pulse Width VVI Backup (for atrial ATP therapy)a Nonprogrammable parameters Parameter Premature event threshold for counting PVCs and Runs of PVCs Fixed blanking periods Atrial blanking after a paced ventricular event (bipolar atrial sensing) Selectable values Atrium; RV Ventricular blanking after a paced atrial event (bipolar ventricular sensing) Manual Ramp therapy parameters Ventricular blanking after a paced atrial event (bipolar ventricular sensing) Crosstalk may occur when atrial pacing amplitude is...

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ADVISA DR MRI™ SURESCAN™ - 8

Brief Statement: Advisa DR MRI™ SureScan™ Pacing System The Advisa DR MRI™ SureScan™ pacing system is MR Conditional and as such is designed to allow patients to undergo MRI under the specified conditions for use. A complete SureScan pacing system, which consists of an approved combination (see http://www.mrisurescan.com/ ) MRI SureScan device with SureScan lead(s), is required for use in the MRI environment. Consult the device manuals to ensure all system components are MR Conditional. Indications The Advisa DR MRI™ SureScan™ Model A2DR01 IPG is indicated for use as a system consisting of...

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