CONSULTA CRT-P Model C4TR01

Transcription

1 CONSULTA CRT-P Model C4TR01 Physical characteristics Volume a 15 cm 3 Mass H x W x D Surface area of titanium device can Surface area of each titanium nitride LECG electrode Radiopaque ID Materials in contact with human tissue Battery 26 g 57 mm x 59 mm x 6 mm 31.8 cm cm 2 PVX a Volume with connector holes unplugged. Longevity Projected service life (years) 500 Ω pacing impedance Titanium, titanium nitride, polyurethane, silicone rubber Lithium silver vanadium oxide with carbon monofluoride Percent Pacing 2.5V b 2.5V b DDD, 0% 0% Atrial 100% Biventricular DDD, 100% 100% Atrial 100% Biventricular Ω pacing impedance b A and RV amplitude at 2.5V, LV amplitude at 3.0V, 0.4 ms pulse width, 100% BiV pacing, the specified percentage of atrial pacing at 60 bpm and the remainder at 70 bpm atrial tracking. Pre-arrhythmia EGM storage is Off. Complete Capture Management OptiVol Fluid Status Monitoring Medtronic CareLink Network Replacement indicators Recommended Replacement Time (RRT) Elective Replacement Indicator (ERI) End of Service (EOS) 2.77 V on 3 consecutive daily automatic measurements 3 months after RRT 3 months after ERI Note: Nominal values indicated in bold. For complete information, review the product clinician manual.

2 Bradycardia Pacing Modes, rates, and intervals Mode Mode Switch Lower Rate Upper Tracking Rate Paced AV Sensed AV PVARP Minimum PVARP DDDR; DDD; DDIR; DDI; AAIR; AAI; VVIR; VVI; DOO; AOO; VOO; ODO 30; 35 50; 55; 60; 70; bpm 80; bpm 180; bpm 30; ms 30; ms Auto; 150; ms 150; ms A. Refractory Period 150; ms Atrial parameters Atrial Amplitude Atrial Pulse Width 0.5; ; 5.5; 6; 8 V c 0.03; 0.06; 0.1; 0.2; 0.3; ms Atrial Sensitivity 0.15; 0.3; 0.45; 0.6; 0.9; 1.2; 1.5; 1.8; 2.1; 4.0 mv Unipolar: 0.45 mv Bipolar: 0.3 mv Atrial Pace Polarity Atrial Sense Polarity Atrial Lead Monitor Min Limit Max Limit Monitor Only; Adaptive 200; 300; 400; 500 Ω 1,000; 1,500; 2,000; 3,000 Ω c When Atrial Amplitude is 8 V, Atrial Pulse Width must be less than 1.3 ms. RV parameters RV Amplitude RV Pulse Width RV Sensitivity RV Pace Polarity RV Sense Polarity RV Lead Monitor Min Limit Max Limit 0.5; ; 5.5; 6; 8 V d 0.03; 0.06; 0.1; 0.2; 0.3; ms 0.45; 0.6; 0.9; 1.2; 2.0; 2.8; 4.0; 5.6; 8.0; 11.3 mv Unipolar: 2.8 mv Bipolar: 0.9 mv Monitor Only; Adaptive 200; 300; 400; 500 Ω 1,000; 1,500; 2,000; 3,000 Ω d When RV Amplitude is 8 V, RV Pulse Width must be less than 1.3 ms. LV parameters LV Amplitude LV Pulse Width LV Pace Polarity LV Lead Monitor Min Limit Max Limit 0.5; ; 5.5; 6; 8 V e 0.03; 0.06; 0.1; 0.2; 0.3; ms LVtip to RVring; LVtip to Can; LVring to RVring; LVring to Can; LVtip to LVring Monitor Only; Adaptive 200; 300; 400; 500 Ω 1,000; 1,500; 2,000; 3,000 Ω V. Pacing RV; RV LV, LV RV V-V Pace Delay 0; ms e When LV Amplitude is 8 V, LV Pulse Width must be less than 1.3 ms. Atrial Capture Management Atrial Capture Management Adaptive; Monitor; Off Amplitude Safety Margin 1.5x; 2.0x; 2.5x; 3.0x Minimum Adapted Amplitude Acute Phase Remaining RV Capture Management RV Capture Management 1.0; 1.5; 2.0; 2.5; 3.0; 3.5 V Off; 30; 60; 90; 120; 150 days Adaptive; Monitor; Off Amplitude Safety Margin 1.5x; 2.0x; 2.5x; 3.0x Minimum Adapted Amplitude Acute Phase Remaining LV Capture Management LV Capture Management 1.0; 1.5; 2.0; 2.5; 3.0; 3.5 V Off; 30; 60; 90; 120; 150 days Adaptive; Monitor; Off Amplitude Safety Margin +0.5; +1.0; +1.5; +2.0; +2.5 Maximum Adapted Amplitude Blanking periods PVAB Interval PVAB Method 0.5; ; 5.5; 6.0 V 10; ms Partial; Partial+; Absolute A. Blank Post AP 150; ms A. Blank Post AS 100; ms V. Blank Post VP 150; ms V. Blank Post VS 120; ; 200; 220; 250; 280; 300; 320 ms

3 Rate response pacing parameters Upper Sensor Rate ADL Rate Rate Profile Optimization 80; bpm 60; bpm ADL Response 1; 2; 3; 4; 5 Exertion Response 1; 2; 3; 4; 5 Activity Threshold Activity Acceleration Activity Deceleration Low; Medium Low; Medium High; High 15; 30; 60 s Exercise; 2.5; 5; 10 min ADL Set Point 5; 6 40; UR Set Point 15; 16 40; 42 80; Rate adaptive AV parameters Rate Adaptive AV Start Rate Stop Rate Minimum Paced AV Minimum Sensed AV V. sense response parameters Off; On V. Sense Response 50; bpm 55; bpm 30; ms 30; ms 95; bpm Rate drop response parameters Rate drop response f Detection Type Drop Size Drop Rate Detection Window Off; On Detection Beats 1; 2; 3 Intervention Rate Drop; Low Rate; Both 10; bpm 30; bpm 10; 15; 20; 25; 30 s 1; 1.5; 2; 2.5 min 70; bpm Intervention Duration 1; 2 15 min f When Rate Drop Response is set to On, the lower rate is automatically set to 45 bpm.. Sleep parameters Sleep Sleep Rate 30; 35 50; 55; 60; 70; bpm Bed Time 00:00; 00:10 22:00 23:50 Wake Time 00:00; 00:10 07:00 23:50 Additional pacing features Atrial Tracking Recovery PMT Intervention PVC Response V. Safety Pacing * * Delivered as RV pacing. Atrial Tachyarrhythmia Therapies and Interventions Tachyarrhythmia detection parameters AT/AF Detection Zones 1; 2 AT/AF Interval (Rate) Fast AT/AF Interval (Rate) VT Monitor VT Monitor Interval (Rate) RV Sensitivity (Bipolar sensing polarity) RV Sensitivity (Unipolar sensing polarity) Atrial Sensitivity (Bipolar sensing polarity) Atrial Sensitivity (Unipolar sensing polarity) On; Monitor 150; ms 150; ms Monitor; Off 280; ms 0.45; 0.6; 0.9; 1.2; 2.0; 2.8; 4.0; 5.6; 8.0; 11.3 mv 0.45; 0.6; 0.9; 1.2; 2.0; 2.8; 4.0; 5.6; 8.0; 11.3 mv 0.15; 0.3; 0.45; 0.6; 0.9; 1.2; 1.5; 1.8; 2.1; 4.0 mv 0.15; 0.3; 0.45; 0.6; 0.9; 1.2; 1.5; 1.8; 2.1; 4.0 mv Atrial tachyarrhythmia therapy parameters Antitachy Pacing (ATP) Fast AT/AF Rx Status Therapy Type AT/AF Rx Status Therapy Type Burst+ parameters Ramp; Burst+ Rx1: Ramp; Rx2: Burst+; Rx3: Ramp Ramp; Burst+ Rx1: Ramp; Rx2: Burst+; Rx3: Ramp Initial # S1 Pulses 1; 2 15; 20; 25 A-S1 Interval (%AA) 28; 31; 34; 38; 41 59; 63; 66 84; 88; 91; 94; 97% S1-S2 (%AA) 28; 31; 34; 38; 41 59; 63; 66; 69 84; 88; 91; 94; 97%; Off S2-S3 Decrement Interval Decrement 0; 10; ms; Off 0; 10; 20; 30; 40 ms # Sequences 1;

4 Atrial tachyarrhythmia therapy parameters (cont d.) Ramp parameters Initial # S1 Pulses 1; ; 20; 25 A-S1 Interval (%AA) 28; 31; 34; 38; 41 59; 63; 66 84; 88; 91; 94; 97% Interval Decrement 0; ms # Sequences 1; 2 8; 9; 10 Stop Atrial Rx after (Shared) Rx/Lead Suspect Disable Atrial ATP if it accelerates V. rate? Disable all atrial therapies if atrial lead position is suspect? (Atrial Lead Position Check) Duration to stop Yes; No Yes; No Episode Duration before Rx Delivery 12; 24; 48; 72 hr; None Episode Duration before ATP 0; 1; 2; 3; 4; 5; 7; 10; 15; 20; 25; 30; 40; 50 min; 1; 2; 3; 4; 5; 6; 12; 24 hr Reactive ATP Rhythm Change Time Interval Shared A. ATP A-A Minimum ATP Interval A. Pacing Amplitude 1; 2 6; 8 V Off; 2; 4; 7; 12; 24; 36; 48 hr 100; 110; 120; ms A. Pacing Pulse Width 0.1; ms VVI Backup Pacing VVI Backup Pacing Rate Off; On (Always); On (Auto-Enable) 60; bpm Atrial rate stabilization parameters A. Rate Stabilization Interval Percentage Increment 80; 85; bpm 12.5; 25; 50% Post Mode Switch Overdrive Pacing (PMOP) parameters Post Mode Switch Overdrive Rate 70; 75; bpm Overdrive Duration 0.5; 1; 2; 3; 5; 10; 20; 30; 60; 90; 120 min Conducted AF response parameters Conducted AF Response Response Level Low; Medium; High 80; bpm Ventricular rate stabilization parameters V. Rate Stabilization Interval Increment 80; 85; bpm 100; ms Non-competitive atrial pacing (NCAP) parameters Non-Comp Atrial Pacing NCAP Interval Diagnostics Arrhythmia episode data storage Episode type Treated AT/AF episode log Treated AT/AF episode EGM, markers, and intervals Monitored VT Nonsustained VT Fast A & V Monitored AT/AF SVT Rate Drop Response Patient-activated episodes CareLink Patient-Activated Log Flashback memory interval data before each of the following events: Interrogation, VT monitor episode, Fast A & V episode, AT/AF episode Episode counters* 200; 250; 300; 350; 400 ms Capacity 100 entries 8.25 min 100 entries, 5 min 15 entries, 2 min 15 entries, 2 min 50 entries, 3 min 25 entries, 2.5 min 10 entries 50 entries 3 entries, 1.75 min 2,000 events (includes both A and V events) VT/VF episodes VT, VT-NS (> 4 beats), Fast A & V, PVC runs (2-4 beats), PVC singles, runs of VRS paces, single VRS paces AT/AF episodes AT/AF summary data: % of time AT/AF, average AT/AF time/ day, monitored AT/AF episodes, treated AT/AF episodes, pace-terminated episodes, % of time atrial pacing, % of time atrial intervention, AT NS(> 6 beats) Number of AT/AF episodes AT/AF therapy counters Treated AT/AF episodes and the percentage of episodes terminated Counts of ATP sequences: delivered, aborted * Counters are maintained for the current and previous follow-up sessions. Battery and lead measurements Battery voltage, Remaining longevity, Sensing integrity counter, Atrial lead position check, Lead impedance: A, RV, and LV pacing; Sensing: P/R-wave amplitudes

5 Lead performance trend A, RV, and LV pacing impedances; A, RV, and LV Capture thresholds; P/R-wave amplitudes Cardiac Compass Report Shows up to 14 months of long-term clinical trends: Programming, interrogation, and remote session events; AT/AF burden per day; ventricular rate during AT/AF; percent pacing per day; average ventricular rate (day and night rates); patient activity; heart rate variability; OptiVol fluid index; thoracic impedance Heart Failure Management Report S h ows up to 14 months of long-term trends: Programming, interrogation, and remote session events; OptiVol fluid index; thoracic impedance; A T/AF burden per day; ventricular rate during AT/AF; patient activity; average ventricular rate (day and night rates); heart rate variability; percent pacing per day Rate Histograms Atrial rate, ventricular rate Data collection parameters LECG Source (Leadless ECG) LECG Range (Leadless ECG) EGM 1 Source EGM 1 Range EGM 2 Source EGM 2 Range EGM 3 Source EGM 3 Range Monitored Pre-arrhythmia EGM AT/AF Daily Burden Avg. V. Rate During AT/AF Daily Burden Avg. V. Rate During AT/AF V. Rate V. Sensing Episodes Consecuti v e VS to detect Consecutive VP to terminate Device Date/Time A; B; C ±0.05; ±0.75; ±0.1; ±0.15; ±0.2; ±0.3; ±0.4; ±0.6; ±0.8; ±1.2; mv Can to RVring; Can to Aring; RVtip to RVring; Atip to RVring; Atip to Aring; Aring to RVring; RVtip to Can; Atip to Can ±1; ±2; ±4; ±8; ±12; ±16; ±32 mv Can to RVring; RVtip to RVring; RVtip to Can ±1; ±2; ±4; ±8; ±12; ±16; ±32 mv Can to RVring; Can to Aring; RVtip to RVring; Atip to RVring; Atip to Aring; LVtip to Can; LVtip to LV ringg; LVtip to RVring ±1; ± 2; ±4; ±8; ±12; ±16; ±32 mv EGM1 and EGM2; EGM1 and EGM3; EGM1 and LECG; EGM2 and EGM3; EGM2 and LECG; EGM3 and LECG Off; On 1 month; On 3 months; On Continuous 0.5; 1; 2; 6; 12; 24 hr 0.5; 1; 2; 6; 12; 24 hr 90; ; 140; 150 bpm 5; 8; 10; 15; 20; 30 ; 40; 50; 100; 150; 200 2; 3; 5; 10 (enter time and date) Holter Telem e try Off; 0.5; 1; 2; 4; 8; 16; 24; 36; 46 hr g A bipolar LV lead must be present for this configuration.

6 Brief Statement: CRT-IPGs Indications Cardiac Resynchronization Therapy (CRT) IPGs: are indicated for NYHA Functional Class III and IV patients who remain symptomatic despite stable, optimal heart failure medical therapy and have a LVEF 35% and a prolonged QRS duration and for NYHA Functional Class I, II, or III patients who have a LVEF 50%, are on stable, optimal heart failure medical therapy if indicated and have atrioventricular block (AV block) that are expected to require a high percentage of ventricular pacing that cannot be managed with algorithms to minimize right ventricular pacing. Optimization of heart failure medical therapy that is limited due to AV block or the urgent need for pacing should be done post implant. Rate adaptive pacing is provided for those patients developing a bradycardia indication who might benefit from increased pacing rates concurrent with increases in activity. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony. Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrythmias in patients with one or more of the above pacing indications. Contraindications CRT IPGs: are contraindicated for concomitant implant with another bradycardia device and concomitant implant with an implantable cardioverter defibrillator. There are no known contraindications for the use of pacing as a therapeutic modality to control heart rate. The patient s age and medical condition, however, may dictate the particular pacing system, mode of operation, and implant procedure used by the physician. Rate-responsive modes may be contraindicated in those patients who cannot tolerate pacing rates above the programmed Lower Rate. Dual chamber sequential pacing is contraindicated in patients with chronic or persistent supraventricular tachycardias, including atrial fibrillation or flutter. Asynchronous pacing is contraindicated in the presence (or likelihood) of competition between paced and intrinsic rhythms. Single chamber atrial pacing is contraindicated in patients with an AV conduction disturbance. Antitachycardia pacing (ATP) therapy is contraindicated in patients with an accessory antegrade pathway. Warnings and Precautions: Changes in a patient s disease and/or medications may alter the efficacy of the device s programmed parameters. Patients should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset, or device damage. Do not place transthoracic defibrillation paddles directly over the device. Additionally, for CRT IPGs, certain programming and device operations may not provide cardiac resynchronization. Also for CRT IPGs, Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm. In this mode, patients may experience loss of cardiac resynchronization therapy and / or loss of AV synchrony. For this reason, the device should be replaced prior to ERI being set. Use of the device should not change the application of established anticoagulation protocols. Potential Complications: Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve stimulation, oversensing, failure to detect and/or terminate arrhythmia episodes, and surgical complications such as hematoma, infection, inflammation, and thrombosis. See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at and/or consult the Medtronic website at medtronic.com. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Medtronic and the Medtronic logo are trademarks of Medtronic. Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. Medtronic 710 Medtronic Parkway Minneapolis, MN USA Toll-free in USA: Worldwide: medtronic.com UC a EN 2016 Medtronic. Minneapolis, MN. All Rights Reserved. Printed in USA. 12/2016