VIVA S CRT-D Model DTBB1D1 IS1/DF-1

Transcription

1 VIVA S CRT-D Moel DTBB1D1 IS1/DF-1 Physil hrteristis Physil hrteristis Volume 35 m 3 Mss H x W x D 80 g Surfe re of evie n 57 m 2 Riopque ID Mterils in ontt with humn tissue Bttery 71 mm x 51 mm x 13 mm PXT Titnium, polyurethne, silione ruer Hyri CFx lithium/silver vnium oxie Volume with onnetor ports unplugge. Grommets my protrue slightly eyon the n surfe. The riopque ID, whih inlues Metroni-ientifier symol, n e viewe in fluorosopi imge of the evie. These mterils hve een suessfully teste for the ility to voi iologil inomptiility. The evie oes not proue n injurious temperture in the surrouning tissue uring norml opertion. PhysioCurve Design CrioSyn Optimiztion SmrtShok Tehnology OptiVol 2.0 Flui Sttus Monitoring Replement initors Reommene Replement Time (RRT) En of Servie (EOS) 2.73 V on 3 onseutive ily utomti mesurements 3 months fter RRT Complete Cpture Mngement Mximum energy levels n typil full energy hrge times Mximum progrmme energy Mximum elivere energy, Mximum store energy Typil hrge time t Beginning of Servie (BOS) Typil hrge time t Reommene Replement Time (RRT) 35 J 36 J 42 J 8.3 s 12.0 s elivere t onnetor lok into 50 Ω lo. For 35 J progrmme energy, elivere energy exees 35 J. store t hrge en on pitor. Chrge time uring nonwireless telemetry session my e slightly higher.

2 Devie prmeters Thyrrhythmi etetion prmeters AT/AF Detetion Zones 1 ; 2 On; Monitor AT/AF Intervl (Rte) 150; ms Fst AT/AF Intervl (Rte) 150; ms VF Detetion On ; Off VF Intervl (Rte) 240; ms 12/16; 18/24; 24/32; 30/40 ; VF Initil Bets to Detet 45/60; 60/80; 75/100; 90/120; 105/140; 120/160 VF Bets to Reetet 6/8; 9/12; 12/16 ; 18/24; 21/28; 24/32; 27/36; 30/40 FVT Detetion Off ; vi VF; vi VT FVT Intervl (Rte) 200; ms VT Detetion VT Intervl (Rte) 280; ms VT Initil Bets to Detet 12; 16 52; 76; 100 VT Bets to Reetet 8; VT Monitor Monitor ; Off VT Monitor Intervl (Rte) 280; ms Monitore VT Bets to Detet PR Logi /Wvelet 16; 20; 24; 32 56; 80; 110; 130 AF/Afl On ; Off Sinus Th On ; Off Other 1:1 SVTs Wvelet On ; Off; Monitor Templte [te] Mth Threshol 40; 43; % Auto Colletion SVT V. Limit 240; 250; ms Other enhnements Stility Off ; 30; ms Onset Off ; On; Monitor Onset Perent 72; 75; 78; 81 ; 84; 88; 91; 94; 97% High Rte Timeout Off ; 0.25; 0.5; 0.75; 1; 1.25; VF Zone Only 1.5; 1.75; 2; 2.5; 3; 3.5; 4; 4.5; 5 min All Zones Off ; 0.5; 1; 1.5 5; 6; 7 20; 22; 24; 26; 28; 30 min T-Wve On ; Off RV Le Noise On; On+Timeout ; Off Timeout 0.25; 0.5; min Sensitivity 0.15; 0.30 ; 0.45; 0.60; 0.90; Atril, 1.20; 1.50; 1.80; 2.10; 4.00 mv 0.15; 0.30 ; 0.45; 0.60; 0.90; RV, 1.20 mv The mesure intervls re trunte to 10 ms multiple (for exmple, 457 ms eomes 450 ms). The evie uses this trunte intervl vlue when pplying the progrmme riteri n lulting intervl verges. The AF/Afl, Sinus Th, n Wvelet fetures re utomtilly set to On when VF Detetion is set to On. This setting pplies to ll sensing in this hmer for oth thyrrhythmi etetion n ryri ping opertions. Crefully evlute the possiility of inrese suseptiility to EMI n oversensing efore hnging the sensitivity threshol to its minimum (most sensitive) setting of 0.15 mv. Atril thyrrhythmi therpy prmeters Antithy Ping (ATP) AT/AF Rx Sttus 50 Hz; Rmp; Burst+ Therpy Type Rx1: Rmp ; Rx2: Burst+ ; Rx3: 50 Hz Fst AT/AF Rx Sttus 50 Hz; Rmp; Burst+ Therpy Type Rx1: Rmp ; Rx2: Burst+ ; Rx3: 50 Hz Ptient-Ativte CV Ptient-Ativte CV Sttus Pthwy Automti CV AT/AF Automti CV Sttus Pthwy Fst AT/AF Automti CV Sttus Pthwy Shre CV Minimum R-R Intervl 400; ms Ative Cn /SVC Coil Cn+SVC On ; Cn Off; SVC Off

3 Atril thyrrhythmi therpy prmeters, ontinue Automti CV Limits Delivery Winow 00:00; 01:00; 02:00; 03:00 Strt Time 23:00 Delivery Winow Length 1 ; 2; 3; 4; 6; 8; 10; 12; 16; 20; 24 hr Mximum Shoks per Dy 1 ; 2; 3; 4; 5; No Limit Episoe Durtion efore Rx Delivery Episoe Durtion efore CV 0; 1; 2; 3; 4; 5; 7; 10; 15; 20; 25; 30; 40; 50 min; 1; 2; 3; 4; 5; 6 ; 12; 24; 48; 72 hr; 7 ys 50 Hz Burst prmeters 50 Hz Burst Durtion 0.5; 1 ; 2; 3 s # Sequenes 1; 2 10 Burst+ prmeters Initil # S1 Pulses 1; 2 15 ; 20; 25 A-S1 Intervl (%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; ; 88; 91; 94; 97%; Off S2-S3 Derement 0; 10 ; ms; Off Intervl Derement 0; ms # Sequenes 1; Rmp prmeters Initil # S1 Pulses 1; ; 20; 25 A-S1 Intervl (%AA) 28; 31; 34; 38; 41 59; 63; 66 84; 88; 91 ; 94; 97% Intervl Derement 0; ms # Sequenes 1; 2 8 ; 9; 10 Stop Atril Rx fter (Shre) Rx/Le Suspet Disle Atril ATP if it elertes V. rte? Yes ; No Disle ll tril therpies if tril le position is suspet? (Atril Le Position Chek) Yes ; No Durtion to stop 12; 24; 48 ; 72 hr; None Episoe Durtion efore Rx Delivery Episoe Durtion efore 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 Retive ATP Rhythm Chnge On ; Off Time Intervl Off; 2; 4; 7 ; 12; 24; 36; 48 hr Shre A. ATP A-A Minimum ATP Intervl 100; 110; 120; ms A. Ping Amplitue 1; 2 6 ; 8 V A. Ping Pulse With 0.1; ms VVI/VOO Bkup Ping VVI/VOO Bkup Ping Rte (Alwys); On (Auto-Enle) 60; pm If the Ative Cn /SVC Coil prmeter is set to Cn Off, the Ative Cn eletroe is not use s prt of the high-voltge elivery pthwy. If the Ative Cn /SVC Coil prmeter is set to SVC Off, the SVC Coil eletroe is not use s prt of the high-voltge elivery pthwy. The mesure intervls re trunte to 10 ms multiple (for exmple, 457 ms eomes 450 ms). The evie uses this trunte intervl vlue when pplying the progrmme riteri n lulting intervl verges. The Ative Cn /SVC Coil prmeter pplies to ll utomti, mnul, n emergeny high-voltge therpies. It lso pplies to T-Shok TM inutions. V. Bkup Ping is elivere to the RV hmer. Ventriulr thyrrhythmi therpy prmeters VF Therpy prmeters VF Therpy Sttus On ; Off Rx1-Rx2: 0.4; ; 2; 3 16; 18; 20; 22; Rx3-Rx6: 10; 11 16; 18; 20; 22; 24; 25; 26; 28; 30; 32; 35 J Pthwy Rx1-Rx4: B>AX ; Rx5-Rx6: AX>B ATP During Chrging ; Before Chrging; Off Deliver ATP if lst 8 R-R 200; ms Therpy Type Burst ; Rmp; Rmp+ ChrgeSver On ; Off Swith when numer of onseutive ATP suesses equls 1 ; 2; 3; 4; 6; 8; 10 Smrt Moe On ; Off

4 Ventriulr thyrrhythmi therpy prmeters, ontinue VT/FVT Therpy prmeters VT Therpy Sttus FVT Therpy Sttus Therpy Type CV; Burst; Rmp; Rmp+ Rx1: Burst ; Rx2-Rx6: CV VT Rx1-Rx2: 20 J VT Rx3-Rx6: 35 J; FVT Rx1-Rx6: 35 J Pthwy Rx1-Rx4: B>AX ; Rx5-Rx6: AX>B Burst therpy prmeters Initil # Pulses 1; R-S1 Intervl = (%RR) 50; 53; 56; 59; 63; 66 84; 88 ; 91; 94; 97% Intervl De 0; ms # Sequenes 1; 2 10 VT Therpies: 3 ; FVT Therpies: 1 Smrt Moe Rmp therpy prmeters Initil # Pulses 1; R-S1 Intervl = (%RR) 50; 53; 56; 59; 63; 66 84; 88; 91 ; 94; 97% Intervl De 0; ms # Sequenes 1; 2 10 VT Therpies: 3 ; FVT Therpies: 1 Smrt Moe Rmp+ therpy prmeters Initil # Pulses 1; 2; 3 15 R-S1 Intervl = (%RR) 50; 53; 56; 59; 63; ; 88; 91; 94; 97% S1S2 (Rmp+) = (%RR) 50; 53; 56; 59; 63; 66; 69 84; 88; 91; 94; 97% S2SN (Rmp+) = (%RR) 50; 53; 56; 59; 63; 66 84; 88; 91; 94; 97% # Sequenes 1; 2 10 VT Therpies: 3 ; FVT Therpies: 1 Smrt Moe Shre Settings V-V Minimum ATP Intervl 150; ms V. Amplitue 1; 2 6; 8 V V. Pulse With 0.1; ms V. Pe Blnking 170; ms V. Ping RV ; RV+LV; LV Ative Cn SVC Coil Cn+SVC On ; Cn Off; SVC Off Progressive Episoe Therpies Confirmtion+ On ; Off If the Ative Cn /SVC Coil prmeter is set to Cn Off, the Ative Cn eletroe is not use s prt of the high-voltge elivery pthwy. If the Ative Cn /SVC Coil prmeter is set to SVC Off, the SVC Coil eletroe is not use s prt of the highvoltge elivery pthwy. Smrt Moe is ville only for Rx1-Rx4. The Ative Cn /SVC Coil prmeter pplies to ll utomti, mnul, n emergeny high-voltge therpies. It lso pplies to T-Shok inutions. If RV+LV is selete, the ATP therpy is elivere LV"RV with 2.5 ms ely. Ping prmeters Moes, rtes, n intervls DDDR; DDD ; DDIR; DDI; AAIR; Moe AAI; VVIR; VVI; DOO; AOO; VOO; ODO Moe Swith On ; Off 30; ; 55; 60; 70; Lower Rte pm Upper Trking Rte 80; pm Pe AV 30; ms Sense AV 30; ms PVARP Auto ; 150; ms Minimum PVARP 150; ms A. Refrtory Perio 150; ms The orresponing Lower Rte Intervl n e lulte s follows: Lower Rte Intervl (ms) = 60,000/Lower Rte. Atril prmeters Atril Amplitue 0.5; ; 5.5; 6; 8 V 0.03; 0.06; 0.1; 0.2; 0.3; Atril Pulse With ms 0.15; 0.3 ; 0.45; 0.6; 0.9; 1.2; 1.5; Atril Sensitivity 1.8; 2.1; 4.0 mv This setting pplies to ll sensing in this hmer for oth thyrrhythmi etetion n ryri ping opertions.

5 RV prmeters RV Amplitue 0.5; ; 5.5; 6; 8 V RV Pulse With 0.03; 0.06; 0.1; 0.2; 0.3; ms RV Sensitivity 0.15; 0.3 ; 0.45; 0.6; 0.9; 1.2 mv RV Pe Polrity RV Sense Polrity Bipolr; Tip to Coil Bipolr; Tip to Coil This setting pplies to ll sensing in this hmer for oth thyrrhythmi etetion n ryri ping opertions. LV prmeters LV Amplitue 0.5; ; 5.5; 6; 8 V LV Pulse With 0.03; 0.06; 0.1; 0.2; 0.3; ms LV Pe Polrity LVtip to RVoil; LVring to RVoil; LVtip to LVring; LVring to LVtip CRT ping prmeters V Ping RV; RV"LV; LV"RV V-V Pe Dely 0 ; ms V. Sense Response On ; Off Mximum Rte 95; pm Atril Trking Reovery On ; Off Atril Cpture Mngement prmeters Atril Cpture Mngement Aptive ; Monitor; Off Atril Amplitue Sfety Mrgin 1.5x; 2.0x ; 2.5x; 3.0x Atril Minimum Apte Amplitue 1.0; 1.5 ; 2.0; 2.5; 3.0; 3.5 V Atril Aute Phse Remining Off; 30; 60; 90; 120 ; 150 ys RV Cpture Mngement prmeters RV Cpture Mngement Aptive ; Monitor; Off RV Amplitue Sfety Mrgin 1.5x; 2.0x ; 2.5x; 3.0x RV Minimum Apte Amplitue 1.0; 1.5; 2.0 ; 2.5; 3.0; 3.5 V RV Aute Phse Remining Off; 30; 60; 90; 120 ; 150 ys LV Cpture Mngement prmeters LV Cpture Mngement Aptive ; Monitor; Off LV Amplitue Sfety Mrgin +0.5; +1.0; +1.5 ; +2.0; +2.5 V LV Mximum Apte 0.5; ; 5.5; 6 V Amplitue Blnking perios PVAB Intervl 10; ms 100; ms PVAB Metho Prtil ; Prtil+; Asolute A. Blnk Post AP 150; ms A. Blnk Post AS 100 ; ms V. Blnk Post VP 170; ms V. Blnk Post VS 120 ; ms When PVAB Metho = Prtil+ or Asolute. When PVAB Metho = Prtil. Progrmming the PVAB Metho to Asolute will utomtilly reset the intervl to 30 ms. If the PVAB Metho is progrmme to Prtil or Prtil+, the intervl will utomtilly e reset to 150 ms. Rte response ping prmeters Upper Sensor Rte 80; pm ADL Rte 60; pm Rte Profile Optimiztion On ; Off ADL Response 1; 2; 3 ; 4; 5 Exertion Response 1; 2; 3 ; 4; 5 Ativity Threshol Low; Meium Low ; Meium High; High Ativity Aelertion 15; 30 ; 60 s Ativity Deelertion Exerise ; 2.5; 5; 10 min ADL Set Point 5; 6 40; UR Set Point 15; 16 40; 42 80; Rte ptive AV prmeters Rte Aptive AV Strt Rte 50; pm Stop Rte 55; pm Minimum Pe AV 30; ms Minimum Sense AV 30; ms

6 Atril rte stiliztion prmeters A. Rte Stiliztion Mximum Rte 80; pm Intervl Perentge Inrement 12.5; 25 ; 50% Atril preferene ping prmeters A. Preferene Ping Mximum Rte 80; pm Intervl Derement 30 ; ; 150 ms Serh Bets 5; 10; 15; 20 25; 50 Post Moe Swith Overrive Ping (PMOP) prmeters Post Moe Swith Overrive Rte 70; 75; pm Overrive Durtion 0.5; 1; 2; 3; 5; 10 ; 20; 30; 60; 90; 120 min Conute AF response prmeters Conute AF Response On ; Off Response Level Low; Meium ; High Mximum Rte 80; pm Ventriulr rte stiliztion prmeters V. Rte Stiliztion Mximum Rte 80; pm Intervl Inrement 100; ms Post VT/VF shok ping prmeters Post VT/VF Shok Ping Overrive Rte 70; 75; pm Overrive Durtion 0.5 ; 1; 2; 3; 5; 10; 20; 30; 60; 90; 120 min Post shok ping prmeters Post Shok A. Amplitue 1; 2; 3; 4 ; 5; 6; 8 V Post Shok A. Pulse 0.1; ms With Post Shok V. Amplitue 1; 2 6 ; 8 V Post Shok V. Pulse 0.1; ms With Applies to ll ventriulr hmers pe. Rte rop response prmeters Rte Drop Response Detetion Type Drop ; Low Rte; Both Drop Size 10; pm Drop Rte 30; pm Detetion Winow 10; 15; 20; 25; 30 s 1 ; 1.5; 2; 2.5 min Detetion Bets 1; 2; 3 ets Intervention Rte 70; pm Intervention Durtion 1; 2 15 min When Rte Drop Response is set to On, the lower rte is utomtilly set to 45 pm. Sleep prmeters Sleep Sleep Rte 30; ; 55; 60; 70; pm Be Time 00:00; 00:10 22:00 23:50 Wke Time 00:00; 00:10 07:00 23:50 Non-Competitive Atril Ping (NCAP) prmeters Non-Comp Atril Ping On ; Off NCAP Intervl 200; 250; 300 ; 350; 400 ms Aitionl ping fetures PMT Intervention PVC Response On ; Off V. Sfety Ping On ; Off Delivere s RV ping.

7 Metroni CreAlert prmeters Clinil mngement lerts OptiVol 2.0 Flui Settings Devie Tone OptiVol Alert Enle Off (Oservtion only) OptiVol Threshol 30; 40; 50; AT/AF Buren n Rte Settings Devie Tone Alert Urgeny High ; Low AT/AF Dily Buren Alert Enle Off (Oservtion only) ; On Avg. V. Rte During AT/AF Alert Enle Off (Oservtion only) ; On Ptient Home Monitor AT/AF Dily Buren Alert Enle Off ; On Avg. V. Rte During AT/AF Alert Enle Off ; On Shre (Devie Tone n Ptient Home Monitor) AT/AF Dily Buren 0.5; 1; 2; 6 ; 12; 24 hours/y Avg. V. Rte During AT/AF 90; pm Dily Buren for Avg. V. Rte 0.5; 1; 2; 6 ; 12; 24 hours/y Numer of Shoks Delivere in n Episoe Devie Tone Alert Enle Urgeny Off ; On-Low; On-High Ptient Home Monitor Alert Enle Off ; On Shre (Devie Tone n Ptient Home Monitor) Numer of Shoks Threshol 1 ; 2; 3; 4; 5; 6 All Therpies in Zone Exhuste for n Episoe Devie Tone Alert Enle Urgeny Off ; On-Low; On-High Ptient Home Monitor Alert Enle Off ; On This prmeter is isplye only if n ssoite lert hs een enle. Alerts re progrmmle n trnsmittle to monitor only when Ptient Home Monitor is progrmme to Yes. Deresing the OptiVol Threshol will mke the evie more sensitive to hnges in the ptient s thori flui sttus. Inresing the OptiVol Threshol oul ely or prevent evie oservtion of signifint hnges in the ptient s thori flui sttus. Note tht VF, VT, n FVT therpies oul e elivere uring single episoe (from initil etetion until episoe termintion). Le/Devie integrity lerts RV Le Devie Tone Alert Urgeny Low; High RV Le Integrity Enle On ; Off RV Le Noise Enle On ; Off Ptient Home Monitor RV Le Integrity Enle On ; Off RV Le Noise Enle On ; Off Le Impene Out of Rnge Devie Tone Alert Urgeny Low; High A. Ping Impene Enle On ; Off (Oservtion only) RV Ping Impene Enle On ; Off (Oservtion only) LV Ping Impene Enle On ; Off (Oservtion only) RV Defirilltion Impene Enle On ; Off (Oservtion only) SVC Defirilltion Impene Enle On ; Off (Oservtion only) Ptient Home Monitor A. Ping Impene Enle RV Ping Impene Enle LV Ping Impene Enle RV Defirilltion Impene Enle SVC Defirilltion Impene Enle, Shre (Devie Tone n Ptient Home Monitor) A. Ping Impene Less 200 ; 300; 400; 500 Ω thn A. Ping Impene Greter thn RV Ping Impene Less thn RV Ping Impene Greter thn LV Ping Impene Less thn LV Ping Impene Greter thn RV Defirilltion Impene Less thn RV Defirilltion Impene Greter thn SVC Defirilltion Impene Less thn SVC Defirilltion Impene Greter thn 1,000; 1,500; 2,000; 3,000 Ω 200 ; 300; 400; 500 Ω 1,000; 1,500; 2,000; 3,000 Ω 200 ; 300; 400; 500 Ω 800; 1,000; 1,500; 2,000; 3,000 Ω 20 ; 30; 40; 50 Ω 100; 130; 160; 200 Ω 20 ; 30; 40; 50 Ω 100; 130; 160; 200 Ω

8 Low Bttery Voltge RRT Devie Tone Alert Enle Urgeny -Low; On-High Ptient Home Monitor Alert Enle Exessive Chrge Time EOS Devie Tone Alert Enle Urgeny -Low; On-High Ptient Home Monitor Alert Enle VF Detetion Off, 3+ VF or 3+ FVT Rx Off Devie Tone Alert Enle -High Ptient Home Monitor Alert Enle This prmeter is isplye only if n ssoite lert hs een enle. If n SVC le is not implnte, the lert will not soun. Alerts re progrmmle n trnsmittle to monitor only when Ptient Home Monitor is progrmme to Yes. Shre prmeters Ptient Home Monitor Yes; No Alert Time 00:00; 00:10 08:00 23:50 This prmeter is isplye only if n ssoite lert hs een enle. Dt olletion prmeters Dt olletion prmeters LECG Soure Cn to SVC, ; RVoil to Aring; (Leless ECG) Cn to Aring LECG Rnge (Leless ECG) ±1; ±2 ; ±4; ±8; ±12; ±16; ±32 mv RVtip to RVoil; RVtip to RVring; EGM 1 Soure Atip to RVring; Atip to Aring ; Aring to RVring; Aring to RVoil EGM 1 Rnge ±1; ±2; ±4; ±8 ; ±12; ±16; ±32 mv Cn to RVoil ; Cn to RVring; EGM 2 (Wvelet) Soure RVtip to RVoil; RVtip to RVring; Cn to SVC, ; RVoil to SVC ; LVtip to SVC ; Cn to LVtip; RVtip to LVtip EGM 2 (Wvelet) Rnge ±1; ±2; ±4; ±8; ±12 ; ±16; ±32 mv RVtip to RVoil; RVtip to RVring ; EGM 3 Soure LVtip to LVring ; LVtip to RVring; LVtip to RVoil; LVring to RV oil EGM 3 Rnge ±1; ±2; ±4; ±8 ; ±12; ±16; ±32 mv EGM1 n EGM2; EGM1 n EGM3 Monitore ; EGM1 n LECG; EGM2 n EGM3; EGM2 n LECG; EGM3 n LECG Pre-rrhythmi EGM Off ; On 1 month; On 3 months; On Continuous V. Sensing Episoes Conseutive VS to 5; 8; 10 ; 15; 20; 30; 40; 50; 100; etet 150; 200 Conseutive VP to terminte 2; 3 ; 5; 10 Devie Dte/Time e (enter time n te) Holter Telemetry Off ; 0.5; 1; 2; 4; 8; 16; 24; 36; 46 hr This EGM hnnel isplys fr-fiel signls. To isply n pproximtion of surfe ECG signl, hoose the Cn to SVC EGM soure. An SVC eletroe must e present for this onfigurtion. If Cn to SVC is selete, the EGM Rnge is utomtilly set to ± 2 mv. The EGM Rnge is utomtilly set to ± 8 mv for ll other EGM Soure options. A ipolr LV le must e present for this onfigurtion. e The times n tes store in episoe reors n other t re etermine y the Devie Dte/Time lok. System test prmeters System test prmeters Seletle vlues Ping Threshol Test prmeters Amplitue; Pulse With; Test Type (LV Test) Phreni Nerve Stim Amplitue; Phreni Nerve Stim Pulse With Test Type (Atrium or RV Test) Amplitue; Pulse With Chmer Atrium; RV; LV Derement fter 2; 3 15 pulses Pe Polrity (RV) Bipolr; Tip to Coil Pe Polrity (LV) LVtip to RVoil; LVring to RVoil; LVtip to LVring; LVring to LVtip Moe (RV or LV test) VVI; VOO; DDI; DDD; DOO Moe (Atrium test) AAI; AOO; DDI; DDD; DOO Lower Rte 30; 35 60; 70; pm RV Amplitue 0.25; 0.5 5; 5.5; 6; 8 V RV Pulse With 0.03; 0.06; 0.1; ms LV Amplitue 0.25; 0.5 5; 5.5; 6; 8 V LV Pulse With 0.03; 0.06; 0.1; ms A. Amplitue 0.25; 0.5 5; 5.5; 6; 8 V A. Pulse With 0.03; 0.06; 0.1; ms AV Dely 30; ms V. Pe Blnking 150; ms A. Pe Blnking 150; ms PVARP 150; ms Sensing Test prmeters Moe AAI; DDD; DDI; VVI; ODO AV Dely 30; ms Lower Rte 30; 35 60; 70; pm

9 CrioSyn Optimiztion Test prmeters Sensing Lower Rte Ping Lower Rte 30; 35 60; 70; pm 35; 40 60; 70; pm Wvelet Test prmeters Mth Threshol 40; Moe AAI; DDD; DDI; VVI; ODO AV Dely 30; ms Lower Rte 30; 35 60; 70; pm The seletle vlues for this prmeter epen on the progrmme ping moe. When performing the test in DDD moe, the Lower Rte must e less thn the progrmme Upper Trking Rte. The seletle vlues for this prmeter epen on the progrmme PVAB vlues. EP stuy prmeters T-Shok inution prmeters Seletle vlues Chmer RV ; RV+LV; LV Resume t Deliver Enle ; Disle Enle Enle; Disle #S1 2; 3; 4; 5 ; 6; 7; 8 S1S1 300; ,000 ms Dely 20; ms 0.4; 0.6; 0.8; ; 2; 3; 4 16; 18; 20; 22; Wveform Monophsi ; Biphsi Pthwy If the hmer selete is RV+LV, the ely is set to 2.5 ms with LV pe elivere If the Ative Cn /SVC Coil prmeter is set to Cn Off, the Ative Cn eletroe is not use s prt of the high-voltge elivery pthwy. If the Ative Cn /SVC Coil prmeter is set to SVC Off, the SVC Coil eletroe is not use s prt of the highvoltge elivery pthwy. 50 Hz Burst inution prmeters Seletle vlues Resume t Burst Enle ; Disle Chmer Atrium; RV; LV Amplitue 1; 2; 3; 4 ; 5; 6; 8 V Pulse With 0.10; ms VOO Bkup (for tril 50 Hz Burst) Ping Rte 60; pm V. Amplitue, 0.50; ; 5.50; 6.00; 8.00 V V. Pulse With 0.10; ms V. Bkup Ping is elivere to the RV hmer. The efult vlue for this prmeter is set oring to the permnently progrmme settings for ryri ping. Crosstlk my our when tril ping mplitue is greter thn 6.0 V. Fixe Burst inution prmeters Seletle vlues Resume t Burst Enle ; Disle Chmer Atrium; RV; RV+LV; LV Intervl 100; ms Amplitue 1; 2; 3; 4 ; 5; 6; 8 V Pulse With 0.10; ms VVI Bkup (for tril Fixe Burst) Ping Rte 60; pm V. Amplitue,e 0.50; ; 5.50; 6.00; 8.00 V V. Pulse With 0.10; ms If the hmer selete is RV+LV, the ely is set to 2.5 ms with LV pe elivere Applies to ll ventriulr hmers pe. V. Bkup Ping is elivere to the RV hmer. The efult vlue for this prmeter is set oring to the permnently progrmme settings for ryri ping. e Crosstlk my our when tril ping mplitue is greter thn 6.0 V. PES inution prmeters Seletle vlues Resume t Deliver Enle ; Disle Chmer Atrium; RV; RV+LV; LV #S1 1; S1S1 100; ,000 ms S1S2 Off; 100; ms S2S3 Off ; 100; ; ms S3S4 Off ; 100; ; ms Amplitue 1; 2; 3; 4 ; 5; 6; 8 V Pulse With 0.10; ms VVI Bkup (for tril PES) Ping Rte 60; pm V. Amplitue e,f 0.50; ; 5.50; 6.00; 8.00 V V. Pulse With e 0.10; ms If the hmer selete is RV+LV, the ely is set to 2.5 ms with LV pe elivere Defult vlue when prmeter is On is 400 ms. Applies to ll ventriulr hmers pe. V. Bkup Ping is elivere to the RV hmer. e The efult vlue for this prmeter is set oring to the permnently progrmme settings for ryri ping. f Crosstlk my our when tril ping mplitue is greter thn 6.0 V. Mnul efirilltion prmeters Seletle vlues Pthwy If the Ative Cn /SVC Coil prmeter is set to Cn Off, the Ative Cn eletroe is not use s prt of the high-voltge elivery pthwy. If the Ative Cn /SVC Coil prmeter is set to SVC Off, the SVC Coil eletroe is not use s prt of the highvoltge elivery pthwy.

10 Mnul rioversion prmeters Seletle vlues Chmer Pthwy Minimum R-R (tril CV only) Atrium; RV 400; ms If the Ative Cn /SVC Coil prmeter is set to Cn Off, the Ative Cn eletroe is not use s prt of the high-voltge elivery pthwy. If the Ative Cn /SVC Coil prmeter is set to SVC Off, the SVC Coil eletroe is not use s prt of the highvoltge elivery pthwy. Shre mnul ATP therpy prmeters Seletle vlues Minimum Intervl (tril ATP) 100; 110; 120; ms Minimum Intervl (ventriulr ATP) 150; ms Amplitue 1; 2 6 ; 8 V Pulse With 0.10; ms VVI Bkup (for tril ATP therpy) Ping Rte 60; pm V. Amplitue, 0.50; ; 5.50; 6.00; 8.00 V V. Pulse With 0.10; ms Applies to ll ventriulr hmers pe. V. Bkup Ping is elivere to the RV hmer. The efult vlue for this prmeter is set oring to the permnently progrmme settings for ryri ping. Crosstlk my our when tril ping mplitue is greter thn 6.0 V. Mnul Burst therpy prmeters Seletle vlues Chmer RV ; RV+LV; LV # Pulses 1; ; 53; 56; 59; 63; 66 84; 88 ; 91; %RR Intervl 94; 97% If the hmer selete is RV+LV, the ely is set to 2.5 ms with LV pe elivere Mnul Rmp+ therpy prmeters Seletle vlues Chmer RV ; RV+LV; LV # Pulses 1; 2; 3 15 R-S1 (%RR) 50; 53; 56; 59; 63; ; 88; 91; 94; 97% S1-S2 (%RR) 50; 53; 56; 59; 63; 66; 69 84; 88; 91; 94; 97% S2-SN (%RR) 50; 53; 56; 59; 63; 66 84; 88; 91; 94; 97% If the hmer selete is RV+LV, the ely is set to 2.5 ms with LV pe elivere Mnul Burst+ therpy prmeters Seletle vlues # S1 Pulses 1; ; 20; %AA Intervl 28; 31; 34; 38; 41 59; 63; 66 84; 88; 91 ; 94; 97% S1S2 Off; 28; 31; 34; 38; 41 59; 63; ; 88; 91; 94; 97% S2S3 De Off; 0; 10; ms Mnul Rmp therpy prmeters Seletle vlues Chmer Atrium; RV; RV+LV; LV Ventriulr Rmp therpy prmeters # Pulses 1; %RR Intervl 50; 53; 56; 59; 63; 66 84; 88; 91; 94; 97 % De/Pulse 0; 10 ; 20; 30; 40 ms Atril Rmp therpy prmeters # Pulses 1; ; 20; %AA Intervl 28; 31; 34; 38; 41 59; 63; 66 84; 88; 91; 94; 97 % De/Pulse 0; 10 ; 20; 30; 40 ms If the hmer selete is RV+LV, the ely is set to 2.5 ms with LV pe elivere

11 Longevity Projete servie life in yers Ping Amplitue RA/RV 15%/100% Brief Sttement LV 100% Projete servie life in yers 500 Ω ping impene Viv S CRT-D Moel DTBB1D4, Viv S CRT-D Moel DTBB1D1 Initions for Use The Viv S CRT-D system is inite for ventriulr ntithyri ping n ventriulr efirilltion for utomte tretment of life-thretening ventriulr rrhythmis, for use in ptients with tril thyrrhythmis, or those ptients who re t signifint risk for eveloping tril thyrrhythmis n for proviing ri resynhroniztion therpy in hert filure ptients on stle, optiml hert filure meil therpy if inite, n meet ny of the following lssifitions: New York Hert Assoition (NYHA) Funtionl Clss III or IV n who hve left ventriulr ejetion frtion 35% n prolonge QRS urtion. Left unle rnh lok (LBBB) with QRS urtion 130 ms, left ventriulr ejetion frtion 30%, n NYHA Funtionl Clss II. NYHA Funtionl Clss I, II, or III n who hve left ventriulr ejetion frtion 50% n trioventriulr lok (AV lok) tht re expete to require high perentge of ventriulr ping tht nnot e mnge with lgorithms to minimize right ventriulr ping. Optimiztion of hert filure meil therpy tht is limite ue to AV lok or the urgent nee for ping shoul e one post-implnt. Le Integrity Alert The RV Le Integrity Alert feture is intene primrily for ptients who hve Metroni ICD or CRT-D evie n Sprint Fielis le (Moels 6949, 6948, 6931, n 6930) se on performne t. The RV LIA feture my not perform s well with St. Jue Meil Rit /Durt le or Boston Sientifi Enotk le s it oes when use with Metroni Sprint Fielis le. This is euse ifferent le esigns my hve ifferent filure signtures n onitions tht my or my not e etete erly y the RV LIA feture. Contrinitions The Viv S CRT-D system is ontrinite for ptients experiening thyrrhythmis with trnsient or reversile uses inluing, ut not limite to, the following: ute myoril infrtion, rug intoxition, rowning, eletri shok, eletrolyte imlne, hypoxi, or sepsis. The evie is ontrinite for ptients who hve unipolr pemker implnte. The evie is ontrinite for ptients with inessnt VT or VF. The evie is ontrinite for ptients whose primry isorer is hroni tril thyrrhythmi with no onomitnt VT or VF. Wrnings n Preutions Chnges in ptient s isese n/or meitions my lter the effiy of the evie s progrmme prmeters. Ptients shoul voi soures of mgneti n eletromgneti rition to voi possile uneretetion, inpproprite sensing n/or therpy elivery, tissue mge, inution of n rrhythmi, evie eletril reset, or evie mge. Do not ple trnsthori efirilltion ples iretly over the evie. Certin progrmming n evie opertions my not provie ri resynhroniztion. Potentil Complitions Potentil omplitions inlue, ut re not limite to, rejetion phenomen, erosion through the skin, musle or nerve stimultion, oversensing, filure to etet n/or terminte thyrrhythmi episoes, elertion of ventriulr thyri, n surgil omplitions suh s hemtom, infetion, inflmmtion, n thromosis. See the Devie Mnul for etile informtion regring the implnt proeure, initions, ontrinitions, wrnings, preutions, n potentil omplitions/ verse events. For further informtion, plese ll Metroni t n/or onsult the Metroni wesite t Cution: Feerl lw (USA) restrits this evie to sle y or on the orer of physiin. 600 Ω ping impene 2.0 V 2.5 V V 4.0 V V 2.5 V V 3.0 V V 4.0 V V 2.5 V V 4.0 V Projete servie life estimtes re se on elerte ttery ishrge t n evie moeling s speifie. Do not interpret these vlues s preise numers. Metroni 710 Metroni Prkwy Minnepolis, MN USA Toll-free in USA: Worlwie: metroni.om Metroni n the Metroni logo re tremrks of Metroni. Thir prty rns re tremrks of their respetive owners. All other rns re tremrks of Metroni ompny. UC EN 2017 Metroni. Minnepolis, MN. All Rights Reserve. Printe in USA. 01/2017