ADVISA DR MRI SURESCAN

Transcription

1 ADVISA DR MRI SURESCAN A2DR01 Product Specifictions MR Conditionl Initil Implnt Existing Implnt Physicl chrcteristics Volume 12.7 cm 3 Mss H x W x D Rdiopque ID c Surfce re of titnium device cn Mterils in contct with humn tissue d Bttery 22 g 45 mm x 51 mm x 8 mm PVX 32.2 cm 2 itnium, polyurethne, silicone ruer Lithium silver vndium oxide with cron monofluoride Volume with connector holes unplugged. Grommets my protrude slightly eyond the cn surfce.. c he rdiopque ID, which includes Medtronic-identifier symol, cn e viewed in fluoroscopic imge of the device. d hese mterils hve een successfully tested for the ility to void iologicl incomptiility. he device does not produce n injurious temperture in the surrounding tissue during norml opertion. Replcement Indictors Recommended Replcement ime (RR) Elective Replcement Indictor (ERI) End of Service (EOS) 2.83 V on 3 consecutive dily utomtic mesurements 3 months fter RR 3 months fter ERI Digitl dul chmer pcemker with SureScn echnology (OAE-DDDR) Longevity Projected service life in yers* Pcing Pre- Arrhythmi EGM Storge 500 Ω pcing impednce 600 Ω pcing impednce 900 Ω pcing impednce 2.5 V 3.5 V 2.5 V 3.5 V 2.5 V 3.5 V DDD, 0% DDD, 15% DDD, 50%

2 AAI <=> DDD (MVP Mode) 50% Atril, 5% Ventriculr DDD, 100% he dt provided for progrmming Pre-rrhythmi EGM storge to is sed on 6-month period (two 3-month follow-up intervls) over the life of the device. Additionl use of Pre-rrhythmi EGM storge reduces projected service life y pproximtely 27% or 3.2 months per yer. * Projected service life estimtes re sed on ccelerted ttery dischrge dt nd device modeling s specified. Do not interpret these vlues s precise numers. Note: hese projections re sed on typicl shelf storge time. Assuming worst-cse shelf storge time (18 months), longevity is reduced y pproximtely 10.1%. Projected service life in yers per conditions specified in EN :2003 Pcing 500 Ω pcing impednce 2.5 V 5.0 V DDDR, 100% Stored dt nd dignostics Arrhythmi episode dt storge Episode type Monitored V episode log Monitored V episode EGM, mrkers, nd intervls Nonsustined V episode log Nonsustined V episode EGM, mrkers, nd intervls Fst A nd V episode log Fst A nd V episode EGM, mrkers, nd intervls reted A/AF episode log reted A/AF episode EGM, mrkers, nd intervls Monitored A/AF episode log Monitored A/AF episode EGM, mrkers, nd intervls SV episode log SV episode EGM, mrkers, nd intervls Rte Drop Response episode log, mrkers, nd intervls Ptient-ctivted episode log Flshck memory intervl dt efore ech of the following events: Interrogtion, V monitor episode, Fst A nd V episode, A/AF episode Cpcity 100 entries 5 min 15 entries 2 min 15 entries 2 min 100 entries 8.25 min 50 entries 3 min 25 entries 2.5 min 10 entries 50 entries 2,000 events (includes oth A nd V-events) V/VF episode counters he V/VF episode counters re mintined for the current follow-up session nd the previous follow-up session. Counts of ech type of V/VF episode V, V-NS (> 4 ets), Fst A&V, PVC runs (2-4 ets), PVC singles, runs of VRS pces, single VRS pces A/AF episode counters he A/AF episode counters re mintined for the current follow-up session nd the previous follow-up session. A/AF summry dt Numer of A/AF episodes % of time A/AF, verge A/AF time/dy, monitored A/AF episodes, treted A/AF episodes, pce-terminted episodes, % of time tril pcing, % of time tril intervention, A NS (> 6 ets) Grouped y durtion Grouped y strt time his counter includes ny instnce when the device identifies A/AF set. herefore, the totl numer of episodes in this counter my exceed the numer of detected A/AF episodes recorded y the device. A/AF therpy counters he A/AF therpy counters re mintined for the current follow-up session nd the previous follow-up session. Numer of A/AF episodes treted nd the percentge of episodes terminted Counts of different types of A/AF therpy Grouped y detection zone nd therpy Grouped y tril cycle length AP sequences: delivered orted Bttery nd led mesurement dt he device utomticlly nd continuously monitors its ttery nd led sttus throughout the life of the device. You my print nd view the following dt: Bttery voltge Remining Longevity Sensing integrity counter Atril led position check Led impednce Sensing Estimted t, Minimum, Mximum Short V-V intervls A. Pcing, RV pcing P-wve nd R-wve mplitudes Led performnce trend dt For 14 dys, the device stores dily mesurements. After 14 dys, the device compresses ech full week of dt into weekly smple for up to 80 weeks. Beyond 82 weeks, dt is mintined on first-collected, first-deleted sis. A. pcing impednce Bipolr, Unipolr, Uni/Bi RV pcing impednce Cpture hreshold P/R Wve Bipolr, Unipolr, Uni/Bi Atril, RV P-wve, R-wve

3 Crdic Compss trend dt Crdic Compss trend dt is ville only s printed report. he report shows up to 14 months of long-term clinicl trends. Ech report contins the following informtion: Progrmming, interrogtion, nd remote session events with dte nd event nnottions; A/AF totl minutes or hours per dy; ventriculr rte during A/AF; percent pcing per dy; verge ventriculr rte (dy nd night rtes); ptient ctivity; hert rte vriility Rte Histogrms dt Rte histogrm dt is ville only s printed report. he report shows the distriution of tril nd ventriculr rtes recorded since the lst ptient session nd in the period efore the lst session. he histogrms show the percentge otl VP, AS-VS, of totl time pced or sensed for the AS-VP, AP-VS, AP-VP following events nd event sequences he histogrms show the rte distriution of pced nd sensed events for the following conditions: Atril rte, ventriculr rte, ventriculr rte during A/AF I f the progrmmed pcing mode during the reporting period ws dul chmer mode, the report displys the AS-VS, AS-VP, AP-VS, nd AP-VP event sequence dt. If single chmer mode ws progrmmed, the report displys the percent of time spent pcing nd sensing. MVP modes (AAIR<=>DDDR nd AAI<=>DDD) re considered dul chmer modes for this purpose. If more thn 2% of tril sensed events re identified s fr-field R-wves, the generl percentge rnge (either 2% to 5% or > 5% ) is reported ove the tril rte histogrm. 0.15; 0.3 ; 0.45; 0.60; 0.90; 1.20; 1.5; 1.80; 2.10; 4.00 mv Atril Sensitivity,c (Unipolr sensing polrity) 0.15; 0.3; 0.45 ; 0.60; 0.90; 1.20; 1.50; 1.80; 2.10; 4.00 mv he mesured intervls re truncted to 10 ms multiple (for exmple, 457 ms ecomes 450 ms). he device uses this truncted intervl vlue when pplying the progrmmed criteri nd clculting intervl verges. his setting pplies to ll sensing in this chmer for oth tchyrrhythmi detection nd rdycrdi pcing opertions. c Crefully evlute the possiility of incresed susceptiility to EMI nd oversensing efore chnging the sensitivity from its nominl setting to the more sensitive settings. When susceptiility to interference in ipolr sensing mode is tested under the conditions specified in CENELEC stndrd EN :2008, cluse , the device my sense the interference if the sensitivity threshold is progrmmed to the minimum vlue of 0.15 mv. he device complies with the requirements of section when the sensitivity threshold is progrmmed to 0.3 mv or higher. When susceptiility to interference in unipolr sensing mode is tested under the conditions specified in CENELEC stndrd EN :2003, cluse , the device my sense the interference if the sensitivity threshold is progrmmed to the vlues elow 1.8 mv. he device complies with the requirements of section when the sensitivity threshold is progrmmed to 1.8 mv or higher. Atril tchyrrhythmi therpy prmeters Progrmmle vlues Antitchy Pcing (AP) Fst A/AF Rx Sttus herpy ype Rmp; Burst+ Rx1: Rmp ; Rx2: Burst+ ; Rx3: Rmp A/AF Rx Sttus herpy ype Rmp; Burst+ Rx1: Rmp ; Rx2: Burst+ ; Rx3: Rmp Burst+ prmeters Device prmeters Emergency settings Atril Sensitivity,c (Bipolr sensing polrity) 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%; Selectle vlues Pcing Mode VVI Lower Rte 70 pm RV 6V S2-S3 Decrement 0; 10 ; ms; RV Pulse Width 1.5 ms Intervl Decrement 0; 10 ; 20; 30; 40 ms RV Pce Polrty Unipolr # Sequences 1; V. Blnk Post VP 240 ms Rmp prmeters Rte Hysteresis Initil # S1 Pulses 1; ; 20; 25 V. Rte Stiliztion A-S1 Intervl (%AA) MRI SureScn 28; 31; 34; 38; 41 59; 63; 66 84; 88; 91 ; 94; 97% Intervl Decrement 0; 10 # Sequences 1; 2 8 ; 9; 10 If the progrmmed RV is 8 V, VVI pcing is delivered t 8 V with pulse width of 1.2 ms. chyrrhythmi detection prmeters Stop Atril Rx fter (Shred) Progrmmle vlues Rx/Led Suspect A/AF Detection ; Monitor Zones 1 ;2 A/AF Intervl (Rte) 150; ms Fst A/AF Intervl (Rte) 150; ms V Monitor Monitor ; V Monitor Intervl (Rte) 280; RV Sensitivity (Bipolr sensing polrity) 0.45; 0.60; 0.9 ; 1.20; 2.00; 2.80; 4.00; 5.60; 8.00; mv RV Sensitivity (Unipolr sensing polrity) 0.45; 0.60; 0.9; 1.20; 2.00; 2.80 ; 4.00; 5.60; 8.00; mv 500 ms 40 ms Disle Atril AP 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 0; 1 ; 2; 3; 4; 5; 7; 10; 15; 20; Episode Durtion efore AP 25; 30; 40; 50 min; 1; 2; 3; 4; 5; 6; 12; 24 hr Rective AP

4 Rhythm Chnge ; ime Intervl ; 2; 4; 7 ; 12; 24; 36; 48 hr Shred A. AP A-A Minimum AP Intervl 100; 110; 120; 130 ms A. Pcing 1; 2 6 ; 8 V A. Pcing Pulse Width 0.1; VVI Bckup Pcing ; (Alwys); (Auto-Enle) VVI Bckup Pcing Rte 60; when the sensitivity threshold is progrmmed to 0.3 mv or higher. When susceptiility to interference in unipolr sensing mode is tested under the conditions specified in CENELEC stndrd EN :2003, cluse , the device my sense the interference if the sensitivity threshold is progrmmed to the vlues elow 1.8 mv. he device complies with the requirements of section when the sensitivity threshold is progrmmed to 1.8 mv or higher. f When Atril is 8 V, Atril Pulse Width must e less thn 1.3 ms. RV prmeters ms RV Modes, rtes, nd intervls Progrmmle vlues Mode DDDR; DDD; AAIR<=>DDDR ; AAI<=>DDD; DDIR; DDI; AAIR; AAI; VVIR; VVI; DOO; AOO; VOO; ODO Mode Switch ; Lower Rte 30; ; 70; pm Upper rcking Rte 80; ; 180; pm Pced AV 30; ms Sensed AV 30; ms PVARP Auto ; 150; ms Minimum PVARP 150; ms A. Refrctory Period 150; ms he corresponding Lower Rte Intervl cn e clculted s follows: Lower Rte Intervl (ms) = 60,000/Lower Rte. Atril prmeters 1.5 ms RV Sensitivity 0.45; 0.60; 0.90; 1.20; 2.00; 2.80; 4.00; 5.60; 8.00; mv Unipolr: 2.80 mv Bipolr: 0.90 mv RV Pce Polrity Bipolr; Unipolr RV Sense Polrity Bipolr; Unipolr RV Led Monitor Monitor ly; Adptive Min Limit 200 ; 300; 400; 500 Ω Mx Limit 1,000; 1,500; 2,000; 3,000 Ω When tested per CENELEC stndrd EN :2003, the tolernce (+ 40%/- 30% for voltges less thn 2.0, nd ± 30% for voltges greter thn or equl to 2.0) is pplied not to the progrmmed setting, ut to the clculted mplitude A, which depends on the progrmmed mplitude Ap nd progrmmed pulse width Wp: A = Ap x (0.9 [Wp x ms-1]). When tested per CENELEC stndrd EN :2003, the mesured pulse width W depends on the lod Rlod (in Ohms) nd progrmmed pulse width Wp (in seconds): W Wp + 34 μs nd W the smller of (Wp - 16 μs) or (124 μs + [4 μs x Rlod]). c With 40 ms sine2 wveform. When using the CENELEC wveform, the rted sensing threshold vlue will e 1.5 times the rted sine2 sensing threshold.. d his setting pplies to ll sensing in this chmer for oth tchyrrhythmi detection nd rdycrdi pcing opertions. e Crefully evlute the possiility of incresed susceptiility to EMI nd oversensing efore chnging the sensitivity from its nominl setting to the more sensitive settings. When susceptiility to interference in unipolr sensing mode is tested under the conditions specified in CENELEC stndrd EN :2003, cluse , the device my sense the interference if the sensitivity threshold is progrmmed to the vlues elow 2.0 mv. he device complies with the requirements of section when the sensitivity threshold is progrmmed to 2.0 mv or higher. f When RV is 8 V, RV Pulse Width must e less thn 1.3 ms. Atril Cpture Mngement prmeters Progrmmle vlues Atril 0.5; Atril Pulse Width 0.03; 0.06; 0.1; 0.2; 0.3; 0.4 Atril Sensitivityc,d,e 0.15; 0.3; 0.45; 0.6; 0.9; 1.2; 1.5; 1.8; 2.1; 4.0 mv Unipolr: 0.45 mv Bipolr: 0.3 mv Atril Pce Polrity Bipolr; Unipolr Atril Sense Polrity Bipolr; Unipolr Atril Led Monitor Monitor ly; Adptive RV Cpture Mngement prmeters Min Limit 200 ; 300; 400; 500 Ω Progrmmle vlues Mx Limit 1,000; 1,500; 2,000; 3,000 RV Cpture Mngement Adptive ; Monitor; 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 ; 30; 60; 90; 120 ; 150 dys 5; 5.5; 6; 8 Vf 1.5 ms Ω When tested per CENELEC stndrd EN :2003, the tolernce (+ 40%/- 30% for voltges less thn 2.0, nd ± 30% for voltges greter thn or equl to 2.0) is pplied not to the progrmmed setting, ut to the clculted mplitude A, which depends on the progrmmed mplitude Ap nd progrmmed pulse width Wp: A = Ap x (0.9 [Wp x ms-1]). When tested per CENELEC stndrd EN :2003, the mesured pulse width W depends on the lod Rlod (in Ohms) nd progrmmed pulse width Wp (in seconds): W Wp + 34 μs nd W the smller of (Wp - 16 μs) or (124 μs + [4 μs x Rlod]). c his setting pplies to ll sensing in this chmer for oth tchyrrhythmi detection nd rdycrdi pcing opertions. d With 20 ms sine2 wveform. When using the CENELEC wveform, the rted sensing threshold vlue will e 1.4 times the rted sine2 sensing threshold. e Crefully evlute the possiility of incresed susceptiility to EMI nd oversensing efore chnging the sensitivity from its nominl setting to the more sensitive settings. When susceptiility to interference in ipolr sensing mode is tested under the conditions specified in CENELEC stndrd EN :2008, cluse , the device my sense the interference if the sensitivity threshold is progrmmed to the minimum vlue of 0.15 mv. he device complies with the requirements of section 5; 5.5; 6; 8 Vf 0.03; 0.06; 0.1; 0.2; 0.3; 0.4 c,d,e Pcing prmeters 0.5; RV Pulse Width 120 pm he mesured intervls re truncted to 10 ms multiple (for exmple, 457 ms ecomes 450 ms). he device uses this truncted intervl vlue when pplying the progrmmed criteri nd clculting intervl verges. Progrmmle vlues Progrmmle vlues Atril Cpture Mngement Adptive ; Monitor; 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 ; 30; 60; 90; 120 ; 150 dys Blnking periods Progrmmle vlues PVAB Intervl 10; PVAB Method Prtil ; Prtil+; Asolute 300 ms

5 Conducted AF response prmeters A. Blnk Post AP 150; ms A. Blnk Post AS 100 ; ms V. Blnk Post VP 150; Conducted AF Response ; V. Blnk Post VS 120 ; ; 200; 220; 250; 280; 300; 320 ms 320 ms Progrmmle vlues Response Level Low; Medium ; High Mximum Rte 80; pm Rte response pcing prmeters Ventriculr rte stiliztion prmeters Progrmmle vlues Progrmmle vlues Upper Sensor Rte 80; V. Rte Stiliztion ADL Rte 60; Mximum Rte 80; ; 120 pm Intervl Increment 100; pm 170 pm Rte Profile Optimiztion ; ADL Response 1; 2; 3 ; 4; 5 Exertion Response 1; 2; 3 ; 4; 5 Activity hreshold Low; Medium Low ; Medium High; High 400 ms Rte drop response prmeters Progrmmle vlues Rte Drop Response Drop ; Low Rte; Both Activity Accelertion 15; 30 ; 60 s Detection ype Activity Decelertion Exercise ; 2.5; 5; 10 min Drop Size 10; pm ADL Setpoint 5; 6 40; Drop Rte 30; pm UR Setpoint 15; 16 40; 42 80; Detection Window 10; 15; 20; 25; 30 s 1 ; 1.5; 2; 2.5 min Rte dptive AV prmeters Detection Bets 1; 2; 3 Progrmmle vlues Intervention Rte 70; Rte Adptive AV ; Intervention Durtion 1; pm min When Rte Drop Response is set to, the lower rte is utomticlly set to 45 pm. Strt Rte 50; Stop Rte 55; pm Sleep prmeters Minimum Pced AV 30; ms Progrmmle vlues 200 ms Sleep Sleep Rte 30; ; 55; 60; 70; pm Bed ime 00:00; 00:10 22:00 23:50 Wke ime 00:00; 00:10 07:00 23:50 Minimum Sensed AV 145 pm ets 30; Atril rte stiliztion prmeters Progrmmle vlues A. Rte Stiliztion Mximum Rte 80; Intervl Percentge Increment 12.5; 25 ; 50% 150 pm Non-Competitive Atril Pcing (NCAP) prmeters Progrmmle vlues Non-Comp Atril Pcing ; Atril preference pcing prmeters NCAP Intervl 200; 250; 300 ; 350; 400 ms Progrmmle vlues MRI SureScn prmeters A. Preference Pcing ; Progrmmle vlues Mximum Rte 80; MRI SureScn Intervl Decrement 30; 40; 50 MRI Pcing Mode DOO; AOO; VOO; ODO Serch Bets 5; 10 MRI Pcing Rte 30; 35 60; 70; pm 150 pm 100; 150 ms 25; 50 Post Mode Switch Overdrive Pcing (PMOP) prmeters Progrmmle vlues Post Mode Switch Overdrive Rte 70; 75; 80 Overdrive Durtion 0.5; 1; 2; 3; 5; 10 ; 20; 30; 60; 90; 120 min 120 pm Note: See the SureScn pcing system technicl mnul for informtion out SureScn progrmmle prmeters. Additionl pcing fetures Progrmmle vlues PM Intervention PVC Response ; V. Sfety Pcing ; Rte Hysteresis ; 30; pm

6 Dt collection prmeters Dt collection prmeters he selectle vlues for this prmeter depend on the progrmmed pcing mode. he selectle vlues for this prmeter depend on the progrmmed Lower Rte. c When performing the test in DDD mode, the Lower Rte must e less thn the progrmmed Upper rcking Rte. Progrmmle vlues EGM 1 Source Cn to RVring; Cn to Aring; RVtip to RVring; Atip to RVring; Atip to Aring ; Aring to RVring; RVtip to Cn; Atip to Cn Selectle vlues EGM 1 Rnge ±1; ±2; ±4; ±8 ; ±12; ±16; ±32 mv Resume t Burst Enled ; Disled EGM 2 Source Cn to RVring; RVtip to RVring ; RVtip to Cn 1; 2; 3; 4 ; 5; 6; 8 V EGM 2 Rnge ±1; ±2; ±4; ±8 ; ±12; ±16; ±32 mv Pulse Width 0.10; Cn to RVring ; Cn to Aring; RVtip to RVring; Atip to RVring; Atip to Aring VOO Bckup EGM 3 Source EP study prmeters 50 Hz Burst induction prmeters Pcing Rte 60; 70 ±1; ±2; ±4; ±8 ; ±12; ±16; ±32 mv V. Monitored EGM1 nd EGM2 ; EGM1 nd EGM3; EGM2 nd EGM3; V. Pulse Width Pre-rrhythmi EGM ; - 1 month; - 3 months; Continuous A/AF Dily Burden 0.5; 1; 2; 6 ; 12; 24 hr EGM 3 Rnge Avg V. Rte During A/AF Dily Burden 0.5; 1; 2; 6 ; 12; 24 hr Avg V. Rte During A/AF V. Rte 90; 100 Device Dte/ime (enter time nd dte) Holter elemetry ; 0.5; 1; 2; 4; 8; 16; 24; 36; 46 hr 150 pm Device Dte/ime clock. Selectle vlues Resume t Burst Enled ; Disled Chmer RV; Atrium Intervl 100; ; 2; 3; 4 ; 5; 6; 8 V Pulse Width 0.10; VVI Bckup (for tril Fixed Burst) Pcing Rte System test prmeters 60; 70 V. V. Pulse Width Pcing hreshold est prmeters ms 1.50 ms 120 pm 0.50; ; 5.50; 6.00; 8.00 V System test prmeters Selectle Vlues 0.10; ms he defult vlue for this prmeter is set ccording to the permnently progrmmed settings for rdycrdi pcing. Fixed Burst induction prmeters he times nd dtes stored in episode records nd other dt re determined y the 120 pm 0.50; ; 5.50; 6.00; 8.00 V 1.50 ms 0.10; ms he defult vlue for this prmeter is set ccording to the permnently progrmmed settings for rdycrdi pcing. Crosstlk my occur when tril pcing mplitude is greter thn 6.0 V. est ype ; Pulse Width PES induction prmeters Chmer Atrium; RV Selectle vlues Decrement fter 2; 3 15 pulses Resume t Deliver Enled ; Disled Mode (RV test) VVI; VOO; DDI; DDD; DOO Chmer RV; Atrium Mode (Atrium test) AAI; AOO; DDI; DDD; DOO #S1 1; 2 8 Lower Rte 30; 35 60; 70; c pm S1S1 100; RV 0.25; 0.5 5; 5.5; 6; 8 V S1S2 ; 100; RV Pulse Width 0.03; 0.06; 0.1; ms S2S3 ; 100; ms A. 0.25; 0.5 5; 5.5; 6; 8 V S3S4 ; 100; ms A. Pulse Width 0.03; 0.06; 0.1; ms 1; 2; 3; 4 ; 5; 6; 8 V AV Dely 30; ms Pulse Width 0.10; V. Pce Blnking 150; ms A. Pce Blnking 150; ms VVI Bckup (for tril PES) PVARP 150; ms Pcing Rte 60; 70 Unipolr; Bipolr V. Pce Polrity Mode V. Pulse Width AAI; DDD; DDI; VVI; ODO AV Dely 30; ms Lower Rtec 30; 35 60; 70; pm 2,000 ms 600 ms 1.50 ms 120 pm 0.50; ; 5.50; 6.00; 8.00 V Sensing test prmeters ; ms he defult vlue for this prmeter is set ccording to the permnently progrmmed settings for rdycrdi pcing. Crosstlk my occur when tril pcing mplitude is greter thn 6.0 V.

7 Shred mnul AP therpy prmeters Minimum Intervl (tril AP) Minimum Intervl (ventriculr AP) Selectle vlues 100; 110; 120; ms 150; ms 1; ; 8 V Pulse Width 0.10; ms VVI Bckup (for tril AP therpy) Pcing Rte 60; pm V. 0.50; ; 5.50; 6.00; 8.00 V V. Pulse Width 0.10; ms Crosstlk my occur when tril pcing mplitude is greter thn 6.0 V. he defult vlue for this prmeter is set ccording to the permnently progrmmed settings for rdycrdi pcing. Mnul Rmp therpy prmeters Chmer Selectle vlues Atrium; RV RV Rmp therpy prmeters # Pulses 1; %RR Intervl 50; 53; 56; 59; 63; 66 84; 88; 91; 94; 97 % Dec/Pulse 0; 10 ; 20; 30; 40 ms Atril Rmp herpy prmeters # Pulses 1; ; 20; %AA Intervl 28; 31; 34; 38; 41 59; 63; 66 84; 88; 91; 94; 97 % Dec/Pulse 0; 10 ; 20; 30; 40 ms Mnul Burst therpy prmeters Selectle vlues # Pulses 1; %RR Interv Mnul Rmp+ therpy prmeters 50; 53; 56; 59; 63; 66 84; 88 ; 91; 94; 97% Selectle vlues # Pulses 1; 2; 3 15 R-S1 (%RR) S1-S2 (%RR) S2-SN (%RR) 50; 53; 56; 59; 63; ; 88; 91; 94; 97% 50; 53; 56; 59; 63; 66; 69 84; 88; 91; 94; 97% 50; 53; 56; 59; 63; 66 84; 88; 91; 94; 97% S1S2 ; 28; 31; 34; 38; 41 59; 63; ; 88; 91; 94; 97% S2S3 Dec ; 0; 10; ms Nonprogrmmle prmeters Nonprogrmmle prmeters Premture event threshold for counting PVCs nd Runs of PVCs Fixed lnking periods Atril lnking fter pced ventriculr event (ipolr tril sensing) Atril lnking fter pced ventriculr event (unipolr tril sensing) Ventriculr lnking fter pced tril event (ipolr ventriculr sensing) Ventriculr lnking fter pced tril event (ipolr ventriculr sensing) Fixed rdycrdi pcing prmeters Ventriculr Sfety Pcing intervls PVARP vlue pplied y PVC Response nd PM Intervention c NCAP vlue pplied y PVC Response nd PM Intervention d Fixed utomtic tril AP therpy prmeters VVI Bckup Pcing mplitude VVI Bckup Pcing pulse width Fixed EP study prmeters Vlue 69% 30 ms 40 ms 30 ms 40 ms 110 ms 400 ms 400 ms 6 V 1.5 ms 50 Hz urst pcing intervl 20 ms Hrdwre prmeters Pcing rte limit e (protective feture) Input impednce Recommended Replcement ime (RR) Bttery Voltge hreshold 171 pm f 150 k Ω minimum 2.83 V 35 ms when the ventriculr pcing mplitude is progrmmed to 8 V. he VSP intervl my e shortened from 110 ms to 70 ms utomticlly y the device t higher pcing rtes when necessry to help support ventriculr tchycrdi detection. c PVARP is extended to 400 ms only if the current PVARP is less thn 400 ms. d he NCAP extension pplies only if NCAP is enled. e Does not pply during AP therpies or ventriculr sfety pcing. f If either the Upper rcking Rte or Upper Sensor Rte (whichever is gretest) is progrmmed to vlue greter thn 150 pm nd less thn or equl to 180 pm, the pcing rte limit is 200 pm. If the Upper rcking Rte is progrmmed to vlue greter thn 180 pm, the pcing rte limit is 230 pm. Mnul Burst+ therpy prmeters Selectle vlues # S1 Pulses 1; ; 20; %AA Intervl 28; 31; 34; 38; 41 59; 63; 66 84; 88; 91 ; 94; 97%

8 Brief Sttement: Advis DR MRI SureScn Pcing System he Advis DR MRI SureScn pcing system is MR Conditionl nd s such is designed to llow ptients to undergo MRI under the specified conditions for use. A complete SureScn pcing system, which consists of n pproved comintion (see ) MRI SureScn device with SureScn led(s), is required for use in the MRI environment. Consult the device mnuls to ensure ll system components re MR Conditionl. Indictions he Advis DR MRI SureScn Model A2DR01 IPG is indicted for use s system consisting of n Advis DR MRI SureScn IPG implnted with two SureScn leds. A complete system is required for use in the MRI environment. he Advis DR MRI SureScn system is indicted for the following: Rte dptive pcing in ptients who my enefit from incresed pcing rtes concurrent with increses in ctivity Accepted ptient conditions wrrnting chronic crdic pcing include: - Symptomtic proxysml or permnent second- or third-degree AV lock - Symptomtic ilterl undle rnch lock - Symptomtic proxysml or trnsient sinus node dysfunctions with or without ssocited AV conduction disorders - Brdycrdi-tchycrdi syndrome to prevent symptomtic rdycrdi or some forms of symptomtic tchyrrhythmis he Advis DR MRI device is lso indicted for dul chmer nd tril trcking modes in ptients who my enefit from mintennce of AV synchrony. Dul chmer modes re specificlly indicted for tretment of conduction disorders tht require restortion of oth rte nd AV synchrony, which include: Vrious degrees of AV lock to mintin the tril contriution to crdic output VVI intolernce (for exmple, pcemker syndrome) in the presence of persistent sinus rhythm Vsovgl syndromes or hypersensitive crotid sinus syndromes Antitchycrdi pcing (AP) is indicted for termintion of tril tchyrrhythmis in rdycrdi ptients with one or more of the ove pcing indictions. Contrindictions he Advis DR MRI SureScn system is contrindicted for concomitnt implnttion with nother rdycrdi device or with n implntle crdioverter defirilltor. here re no known contrindictions for the use of pcing s therpeutic modlity to control hert rte. he ptient s ge nd medicl condition, however, my dictte the prticulr pcing system, mode of opertion, nd implnt procedure used y the physicin. Rte-responsive modes my e contrindicted in those ptients who cnnot tolerte pcing rtes ove the progrmmed Lower Rte Dul chmer sequentil pcing is contrindicted in ptients with chronic or persistent suprventriculr tchycrdis, including tril firilltion or flutter Asynchronous pcing is contrindicted in the presence (or likelihood) of competition etween pced nd intrinsic rhythms Single chmer tril pcing is contrindicted in ptients with n AV conduction disturnce AP therpy is contrindicted in ptients with n ccessory ntegrde pthwy Wrnings/Precutions Chnges in ptient s disese nd/or medictions my lter the efficcy of the device s progrmmed prmeters. Ptients should void sources of mgnetic nd electromgnetic rdition to void possile underdetection, inpproprite sensing nd/or therpy delivery, tissue dmge, induction of n rrhythmi, device electricl reset, or device dmge. Do not plce trnsthorcic defirilltion pddles directly over the device. Use of the device should not chnge the ppliction of estlished nticogultion protocols. Ptients nd their implnted systems must e screened to meet the following requirements for MRI: No led extenders, led dptors or ndoned leds present; no roken leds or leds with intermittent electricl contct s confirmed y led impednce history; pce polrity prmeters set to Bipolr for progrmming MRI SureScn to ; or SureScn pcing system with led impednce vlue of 200 Ω nd 1,500 Ω. he device must e operting within the projected service life nd the system must e implnted in the left or right pectorl region. For pcemker-dependent ptients, it is not recommended to perform n MRI scn if the right ventriculr (RV) led pcing cpture threshold is greter thn 2.0 V t 0.4 ms. Ptients whose device will e progrmmed to n synchronous pcing mode when MRI SureScn is on must hve no diphrgmtic stimultion t pcing output of 5.0 V nd t pulse width of 1.0 ms. It is not recommended to perform MRI scns during the led mturtion period (pproximtely 6 weeks). Ptients my e scnned using horizontl field, cylindricl ore, clinicl 1.5 or 3 MRI system for hydrogen proton imging, mximum sptil grdient 20 /m, nd mximum grdient slew rte performnce per xis 200 /m/s. 1.5 scnners must e operted in Norml Operting Mode (whole ody verged specific sorption rte (SAR) 2.0 W/kg, hed SAR 3.2 W/kg. 3 scnners must e operted in First Level Controlled Operting Mode or Norml Operting Mode. B1 +RMS must e 2.8 μ when the isocenter (center of the ore) is inferior to the C7 verter. Scns cn e performed without B1 +RMS restriction when the isocenter is t or superior to the C7 verter. Proper ptient monitoring must e provided during the MRI scn. Potentil Complictions Potentil complictions include, ut re not limited to, rejection phenomen, erosion through the skin, muscle or nerve stimultion, oversensing, filure to detect nd/or terminte rrhythmi episodes, ccelertion of tchycrdi, nd surgicl complictions such s hemtom, infection, inflmmtion, nd thromosis. Potentil led complictions include, ut re not limited to, vlve dmge, firilltion, thromosis, thromotic nd ir emolism, crdic perfortion, hert wll rupture, crdic tmponde, pericrdil ru, infection, myocrdil irritility, nd pneumothorx. Other potentil complictions relted to the led my include led dislodgement, led conductor frcture, insultion filure, threshold elevtion, or exit lock. he SureScn system hs een designed to minimize potentil complictions in the MRI environment. Potentil MRI complictions include, ut re not limited to, led electrode heting nd tissue dmge resulting in loss of sensing or cpture or oth, or induced currents on leds resulting in continuous cpture, V/VF, nd/or hemodynmic collpse. See the Advis MRI SureScn echnicl Mnul efore performing n MRI Scn nd see the device mnuls for detiled informtion regrding the implnt procedure, indictions, contrindictions, wrnings, precutions, nd potentil complictions/dverse events. For further informtion, cll Medtronic t nd/or consult the Medtronic wesite t or Cution: Federl lw (USA) restricts this device to sle y or on the order of physicin. Medtronic 710 Medtronic Prkwy Minnepolis, MN USA oll-free in USA: Worldwide: medtronic.com UC EN 2016 Medtronic. Minnepolis, MN. All Rights Reserved. Printed in USA. 11/2016