PERCEPTA CRT-P MRI SURESCAN Model W1TR04
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1 PERCEPTA CRT-P MRI SURESCAN Model W1TR04 Hert Filure Mngement Report This report provides n overview of the ptient s condition over the short nd long term, with focus on hert filure mngement. The report includes grphs tht show OptiVol 2.0 fluid trends nd trends relted to hert filure over the lst 14 months. Physicl chrcteristics Volume 20 cm 3 Mss 30 g H x W x D 59 mm x 46.5 mm x 11 mm Rdiopque ID c RNP Surfce re of titnium device cn 40.7 cm 2 Mterils in contct with humn tissue d Bttery Titnium, polyurethne, silicone ruer Lithium-hyrid CFx silver vndium oxide Volume with connector holes unplugged. Grommets my protrude slightly eyond the cn surfce. c The rdiopque ID, which includes Medtronic-identifier symol, cn e viewed in fluoroscopic imge of the device. d These mterils hve een successfully tested for the ility to void iologicl incomptiility. The device does not produce n injurious temperture in the surrounding tissue during norml opertion. Replcement indictors Recommended Replcement Time (RRT) Elective Replcement Indictor (ERI) End of Service (EOS) 180 dys fter 3 consecutive dily utomtic mesurements of 2.63 V or immeditely fter 3 consecutive dily utomtic mesurements of 2.60 V, whichever comes first 3 months fter RRT 3 months fter ERI MR Conditionl with SureScn Technology Bluetooth Wireless Telemetry EffectivCRT Dignostic AdptivCRT Algorithm EffectivCRT During AF Algorithm CrdioSync Optimistion OptiVol 2.0 Fluid Sttus Monitoring MVP Mode Complete Cpture Mngement Dignostic (ACM, RVCM, LVCM)
2 Tchyrrhythmi detection prmeters Tchyrrhythmi detection prmeters AT/AF Detection On; Monitor Zones 1 ; 2 AT/AF Intervl (Rte) 150; ms Fst AT/AF Intervl (Rte) 150; ms VT Monitor Monitor ; Off VT Monitor Intervl (Rte) 280; ms 0.45; 0.60 mv (±50%); 0.90; 1.20; 2.00; 2.80; RV Sensitivity 4.00; 5.60; 8.00; mv (±30%) Bipolr: 0.9 mv Unipolr: 2.80 mv 0.15 mv (±75%); 0.30; 0.45; 0.60 mv (±50%); Atril Sensitivity c 0.90; 1.20; 1.5; 1.8; 2.1; 4.0 mv (±30%); Off Bipolr: 0.3 mv Unipolr: 0.45 mv The mesured intervls re truncted to 10 ms multiple (for exmple, 457 ms ecomes 450 ms). The device uses this truncted intervl vlue when pplying the progrmmed criteri nd clculting intervl verges. The device complies with the requirements of ISO when the sensitivity threshold is progrmmed to 2.0 mv or higher. c The device complies with the requirements of ISO when the sensitivity threshold is progrmmed to 1.8 mv or higher. Atril tchyrrhythmi therpy prmeters Antitchy Pcing (ATP) Fst AT/AF Rx Sttus Therpy Type Rmp; Burst+ Rx1: Rmp ; Rx2: Burst+ ; Rx3: Rmp AT/AF Rx Sttus Therpy Type Rmp; Burst+ Rx1: Rmp ; Rx2: Burst+ ; Rx3: Rmp Burst+ prmeters Initil # S1 Pulses 1; 2; ; 20; 25 A-S1 Intervl (%AA) 28; 31; 34; 38; 41 59; 63; 66; ; 88; 91; 94; 97% S1-S2 (%AA) 28; 31; 34; 38; 41 59; 63; 66; ; 84; 88; 91; 94; 97%; Off S2-S3 Decrement 0; 10; ms; Off Intervl Decrement 0; 10 ; 20; 30; 40 ms # Sequences 1; 2; 3 10 Rmp prmeters Initil # S1 Pulses 1; 2; 3 13 ; 14; 15; 20; 25 A-S1 Intervl (%AA) Rx1 28; 31; 34; 38; 41 59; 63; 66 84; 88; 91 ; 94; 97% Rx2 28; 31; 34; 38; 41 59; 63; 66 84; 88; 91 ; 94; 97% Rx3 28; 31; 34; 38; 41 59; 63; ; 84; 88; 91; 94; 97% Intervl Decrement 0; ms # Sequences 1; 2 8; 9; 10 Stop Atril Rx fter (Shred) Rx/Led Suspect Disle Atril ATP if it ccelertes V. rte? Yes ; No Disle ll tril therpies if tril led position is suspect? (Atril Led Position Check) Yes ; No Durtion to stop 12; 24; 48 ; 72 hr; None Episode Durtion efore Rx Delivery Episode Durtion efore ATP 0; 1 ; 2 5; 7; 10; 15; 20; 25; 30; 40; 50 min; 1; 2; 3; 4; 5; 6; 12; 24 hr Rective ATP Rhythm Chnge On ; Off Time Intervl Off ; 2; 4; 7; 12; 24; 36; 48 hr Shred A. ATP A-A Minimum 100; ms ATP Intervl (± 6 ms) A. Pcing 1; 2 V (+0.5 V -33%) 3; 4; 5; 6 ; 8 V (+20%/-33%) A. Pcing Pulse Width 0.1; ms VVI Bckup Pcing Off; On (Alwys); On (Auto-Enle) VVI Bckup Pcing Rte 60; min -1 The mesured intervls re truncted to 10 ms multiple (for exmple, 457 ms ecomes 450 ms). The device uses this truncted intervl vlue when pplying the progrmmed criteri nd clculting intervl verges. Pcing s Modes, rtes, nd intervls Mode DDDR; DDD ; AAIR<=>DDDR; AAI<=>DDD; DDIR; DDI; AAIR; AAI; VVIR; VVI; DOO; AOO; VOO; ODO Mode Switch On ; Off Lower Rte 30; ; 70; min 1 (±2 min 1 ) Upper Trcking Rte 80; min 1 (±2 min 1 ); 180; min 1 (+2/-11 min 1 ) Pced AV 30; ms (± 4 ms) Sensed AV 30; ms (+30; 2 ms) Mximum AV Intervl Limit Off ; 250; ms 2
3 Modes, rtes, nd intervls, cont d. PVARP Auto ; 150; ms Minimum PVARP A. Refrctory Period 150; ms 150; ms The corresponding Lower Rte intervl cn e clculted s follows: Lower Rte intervl (ms) = 60,000/Lower Rte. If CRT is dptive, Pced AV nd Sensed AV cnnot e selected or progrmmed. Atril prmeters Atril ( V/-33%) (+15%/-33%) Atril Pulse Width 0.03; 0.06 ms (± 10 μs); Atril Sensitivity Off; 0.15; 0.3; 0.45; 0.6 mv (± 60%); 0.9; 1.2; 1.5; 1.8; 2.1; 4.0 mv (± 40%) Unipolr: 0.45 mv Bipolr: 0.3 mv Atril Pce Polrity Bipolr; Unipolr Atril Sense Polrity Bipolr; Unipolr Atril Led Monitor Monitor Only; Adptive Mx Limit 1,000; 1,500; 2,000; 3,000 Ω When Atril is 8 V, Atril Pulse Width must e less thn 1.3 ms. RV prmeters RV ( V / -33%) (+15%/-33%) RV Pulse Width 0.03; 0.06 ms (±10 μs); 0.45; 0.60; 0.90; 1.20; 2.00; 2.80; 4.00; 5.60; 8.00; mv RV Sensitivity (±55%) Unipolr: 2.80 mv Bipolr: 0.90 mv RV Pce Polrity Bipolr; Unipolr RV Sense Polrity Bipolr; Unipolr RV Led Monitor Monitor Only; Adptive Mx Limit 1,000; 1,500; 2,000; 3,000 Ω When RV is 8 V, RV Pulse Width must e less thn 1.3 ms. LV prmeters LV ( V/-33%) (+15% -33%) LV Pulse Width 0.03; 0.06 ms (±10 μs); LV Pce Polrity LVtip to RVring; LVtip to Cn; LVring to RVring; LVring to Cn; LVtip to LVring LV Led Monitor Monitor Only; Adptive Mx Limit 1,000; 1,500; 2,000; 3,000 Ω When LV is 8 V, LV Pulse Width must e less thn 1.3 ms. CRT pcing prmeters AdptivCRT Adptive Bi-V nd LV ; Adptive Bi-V; Nondptive CRT V. Pcing RV; RV LV; LV RV ; LV V-V Pce Dely Auto ; 0; ms EffectivCRT During AF On ; Off Mximum Rte 80; min 1 V. Sense Response On ; Off Mximum Rte 95; min 1 Atril Trcking Recovery On ; Off When LV is 8 V, LV Pulse Width must e less thn 1.3 ms. Atril Cpture Mngement prmeters Atril Cpture Mngement Adptive ; Monitor; Off Atril Sfety Mrgin 1.5x; 2.0x ; 2.5x; 3.0x Atril Minimum Adpted 1.0; 1.5 ; 2.0; 2.5; 3.0; 3.5 V Atril Acute Phse Remining Off; 30; 60; 90; 120 ; 150 dys RV Cpture Mngement prmeters RV Cpture Mngement Adptive ; Monitor; Off RV Sfety Mrgin 1.5x; 2.0x ; 2.5x; 3.0x RV Minimum Adpted 1.0; 1.5; 2.0 ; 2.5; 3.0; 3.5 V RV Acute Phse Remining Off; 30; 60; 90; 120 ; 150 dys LV Cpture Mngement prmeters LV Cpture Mngement Adptive ; Monitor; Off +Auto ; +0.5; +1.0; +1.5; LV Sfety Mrgin +2.0; +2.5 V LV Mximum Adpted 0.5; ; 5.5; 6 V
4 Blnking periods PVAB Intervl 10 ; ; 110; ms PVAB Method Prtil ; Prtil+; Asolute A. Blnk Post AP A. Blnk Post AS V. Blnk Post VP 150; ms (± 5 ms) 100 ; ms (± 2 ms) 150; ms (± 5 ms) 120 ; ; 200; 220; V. Blnk Post VS 250; 280; 300; 320 ms (±2 ms) If the PVAB Method is set to Prtil, the minimum selectle vlue for the PVAB Intervl is 100 ms. Rte response pcing prmeters Rtes ADL Rte 60; min 1 (± 2 min 1 ) Upper Sensor 80; min 1 (± 2 min 1 ) Rte Profile Optimistion On ; Off Adjust Rte Response ADL Response 1; 2; 3 ; 4; 5 Exertion Response 1; 2; 3 ; 4; 5 Additionl s Activity Threshold Low ; Medium Low; Medium High; High Activity Accelertion 15; 30 ; 60 s Activity Decelertion Exercise ; 2.5; 5; 10 min ADL Set Point 5; 6 40; UR Set Point 15; 16 40; 42 80; Rte dptive AV prmeters Rte Adptive AV On ; Off Strt Rte 50; min 1 Stop Rte 55; min 1 Minimum Pced AV 30; ms Minimum Sensed AV 30; ms If CRT is dptive, Rte Adptive AV cnnot e selected or progrmmed. Atril rte stilistion prmeters A. Rte Stilistion Mximum Rte 80; min 1 Intervl Percentge Increment 12.5; 25 ; 50% Post Mode Switch Overdrive Pcing (PMOP) prmeters Post Mode Switch Overdrive Rte 70; 75; min 1 Overdrive Durtion 0.5; 1; 2; 3; 5 ; 10; 20; 30; 60; 90; 120 min Conducted AF response prmeters Conducted AF Response On ; Off Response Level Low; Medium ; High Mximum Rte 80; min 1 Ventriculr rte stilistion prmeters V. Rte Stilistion Mximum Rte 80; 85; min 1 Intervl Increment 100; ms Rte drop response prmeters Rte drop response Detection Type Drop ; Low Rte; Both Drop Detection Drop Size 10; min 1 Drop Rte 30; min 1 Detection Window 10; 15; 20; 25; 30 s 1 ; 1.5; 2; 2.5 min Low Rte Detection Detection Bets 1; 2; 3 ets Intervention Intervention Rte 70; min 1 Intervention Durtion 1; 2 15 min When Rte Drop Response is set to On, the lower rte is utomticlly set to 45 min 1. Sleep prmeters Sleep Sleep Rte Bed Time Wke Time 30; ; 55; 60; 70; min 1 00:00; 00:10 22:00 23:50 00:00; 00:10 07:00 23:50 Non-competitive tril pcing (NCAP) prmeters Non-Comp Atril Pcing On ; Off NCAP Intervl 200; 250; 300 ; 350; 400 ms Additionl pcing fetures PMT Intervention On ; Off PVC Response On ; Off V. Sfety Pcing On ; Off Delivered s LV pcing when LV pcing is permnently progrmmed or the AdptivCRT operting vlue is LV. Delivered s RV pcing when RV only pcing is permnently progrmmed. Otherwise, delivered s BiV pcing. 4
5 Longevity Projected service life in yers, with AdptivCRT progrmmed to Adptive BiV nd LV Percent Pcing 500 Ω pcing impednce 600 Ω pcing impednce Atril % RV% LV% 2.5 V 3.5 V 2.5 V 3.5 V 0% 50% 100% % 50% 100% % 50% 100% % 50% 100% Projected service life estimtes re sed on ccelerted ttery dischrge dt nd device modeling s specified. Do not interpret these vlues s precise numers. IMPORTANT REMINDER See the MRI SureScn technicl mnul efore performing n MRI scn nd the device mnul for detiled informtion regrding the instructions for use, the implnt procedure, indictions, contrindictions, wrnings, precutions, nd potentil dverse events. For further informtion, contct your locl Medtronic representtive or consult the Medtronic wesite t medtronic.com. Consult instructions for use t this wesite. Mnuls cn e viewed using current version of ny mjor Internet rowser. For est results, use Adoe Acrot Reder with the rowser. INDICATIONS, SAFETY, AND WARNINGS See the device mnul t mnuls.medtronic.com for detiled informtion regrding the implnt procedure, indictions, contrindictions, wrnings, precutions, nd potentil dverse events. Medtronic nd the Medtronic logo re trdemrks of Medtronic. Third prty rnds re trdemrks of their respective owners. All other rnds re trdemrks of Medtronic compny. Europe Medtronic Interntionl Trding Sàrl. Route du Molliu 31 Cse postle CH-1131 Tolochenz Tel: Fx: United Kingdom/Irelnd Medtronic Limited Building 9 Croxley Green Business Prk Htters Lne Wtford Herts WD18 8WW Tel: Fx: medtronic.eu UC EE 2016 Medtronic. All Rights Reserved. Printed in Europe. 5
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