BOSTON SCIENTIFIC COGNIS 100-D CRT-D (01) PDF MANUAL


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PDF Content Summary: Остаряла версия. Да не с Zastaralá verze. Nepoužívat. Forældet version. Må ikke anven Version überholt. Nicht verwenden. Aegunud versioon. Ärge kasutage. Παλιά έκδοση. Μην την χρησιμοποιείτε. Outdated version. Do not use. Versión obsoleta. No utilizar. Version périmée. Ne pas utiliser. Zastarjela verzija. Nemojte upotrebljavati. Úrelt útgáfa. Notið ekki. Versione obsoleta. Non utilizzare. Novecojusi versija. Neizmantot. Pasenusi versija. Nenaudokite. Elavult verzió. Ne használja! Dit is een verouderde versie. Niet gebruiken. tdatert versjon. Skal ikke brukes. ja przeterminowana. Nie używać. bsoleta. Não utilize. irată. A nu se utiliza. . Nepoužívať. e uporabite. lä käytä. ej. nmayın. PHYSICIAN’S TECHNICAL MANUAL AUTOGENTM CRT-D, AUTOGENTM X4 CRT-D, DYNAGENTM CRT-D, DYNAGENTM X4 CRT-D, INOGENTM CRT-D, INOGENTM X4 CRT-D, ORIGENTM CRT-D, ORIGENTM X4 CRT-D, INCEPTATM CRT-D, ENERGENTM CRT-D, PUNCTUATM CRT-D, PUNCTUATM NE CRT-D, COGNISTM 100-D CRT-D CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR REF G172, G173, G175, G177, G179, G150, G151, G156, G158, G140, G141, G146, G148, G050, G051, G056, G058, P162, P163, P165, P142, P143, P052, P053, P106, P107, P108 Остаряла версия. Да не с Zastaralá verze. Nepoužívat. Forældet version. Må ikke anven Version überholt. Nicht verwenden. Aegunud versioon. Ärge kasutage. Παλιά έκδοση. Μην την χρησιμοποιείτε. Outdated version. Do not use. Versión obsoleta. No utilizar. Version périmée. Ne pas utiliser. Zastarjela verzija. Nemojte upotrebljavati. Úrelt útgáfa. Notið ekki. Versione obsoleta. Non utilizzare. Novecojusi versija. Neizmantot. Pasenusi versija. Nenaudokite. Elavult verzió. Ne használja! Dit is een verouderde versie. Niet gebruiken. tdatert versjon. Skal ikke brukes. ja przeterminowana. Nie używać. bsoleta. Não utilize. irată. A nu se utiliza. . Nepoužívať. e uporabite. lä käytä. ej. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euuяbrV. tsd . eedNέioДrVrvκaheа sneeδtpióoe. ZнrrοoAdditional Device Related Indications Contraindications Warnings Precautions.....................................................................................................................................9 Supplemental Potential Mechanical Items Symbols Characteristics X-Ray Telemetry Pulse Warranty Product Patient ltssMd n aе σioiou. Úså vηс Nožton Post-Therapy Magnetic Transcutaneous Electrocautery Ionizing Elevated Patient reIncluded Generator a. ívIdentifier bikicDescription..........................................................................................................................1 eVCounseling nInformation.........................................................................................................................4 ΜrReliability rpon Adverse sInformation.....................................................................................................................57 lt sa........................................................................................................................................6 jeekInformation....................................................................................................................51 h. Information oand éioηSpecifications.............................................................................................................34 Nte Packaging..................................................................................................................42 Ärt úla Handbook . lersRadiation Precautionary ν ornPressures..............................................................................................................30 imin vaResonance as iotUsage.....................................................................................................................5 .............................................................................................................................49 gPLongevity............................................................................................................51 tgτve. vPackage n............................................................................................................................5 Events aShipped............................................................................................................47 .........................................................................................................................57 ae nηDInformation áeerPulse év. and Eswe ν facreke.....................................................................................................................1 o NElectrical elazo................................................................................................................29 ................................................................................................................59 an . eoχnRadio . ijao ..............................................................................................................31 DnGenerator Njusvnρ............................................................................................................41 NbImaging uuoit uuInformation.......................................................................................23 de η. ssostt lt t.....................................................................................................58 NoFrequency i eσi is aNerve ptiliztuvvið lengιμedvaseee(MRI) . meeFollow as teTable οarereaStimulation r. ts. surn πozke. ija. ijat....................................................................................24 iókNοjtr(RF) vilisja Up t i. ιεe . of o. . evN............................................................................23 NNAblation pn rίτueeContents oeer(TENS) e rpεruuz. izsn. ohetjodbailizmtta..............................................................28 eursens...........................................................26 earodrz. zdbmnlenSaoe ljatkrákintoevaaljaitirtv. eol . . eaaNikr! w. sttãăi. kieao . e n. A . auNbN. ntrieNilizeuu pt kie segoee se ueu. . ubżžuytívrpilizuwaolä ikaťra. ćeak. . bnä. yitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euuяbrV. tsd . eedNέioДrVLead Implanting Bidirectional Follow Explantation..................................................................................................................................97 rvκaheа sneeδtpióoe. ZнrrοConnections.........................................................................................................................59 oCheck Interrogate Implant Take Form Connect Evaluate Program Test Tachyarrhythmia Implant Complete ltssMd n aе Up σioiou. Úså vηс Nofor Testing..........................................................................................................................95 žtthe Baseline on the Arrhythmias rea. ívbEquipment.................................................................................................................68 ikTorque iceVthe Ability the nΜrrPulse the pthe Lead sImplantation lt sajeekand h. oand éioLead Pulse ηNte ÄrLeads Pulse t úla . lersν to Return Wrench..........................................................................................................93 Measurements Signals oGenerator.....................................................................................................68 rnimvaiotCheck gPConvert tgProgramming System......................................................................................................70 τve. vnGenerator.................................................................................................92 a................................................................................................................87 ae nGenerator...............................................................................................84 ηDto áeerév. Eswe ν fathe cthe rekeo Pocket...............................................................................................75 Nthe e.........................................................................................................81 lazoan . eoχn. ijao Ventricular Pulse DImplantation nNjusPulse vnρNbuuoit uude η. sso..............................................................................................72 stt lt Considerations tNoi eGenerator σi is aptGenerator..........................................................................69 iliztuvvið lengιμedvaseee. Fibrillation meeas teοarereForm ar. ts. surn πozke. ija. ijat...........................................................................76 iókNοjtrvilisja ........................................................................93 t i. ιεe . o. . ev....................................................................90 Nand NNpn rίτueeoeere rpεruInducible uz. izsn. ohetjodbailizmttaeursensearodrz. zdbmnlenSaoe ljatkrákintoevaaljaitirtv. eol . . eaaNikr! w. sttãăi. kieao . e n. A . auNbN. ntrieNilizeuu pt kie segoee se ueu. . ubżžuytívrpilizuwaolä ikaťra. ćeak. . bnä. yitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euuяbrV. tsd . eedNέioДrVADDITIONAL For DEVICE This ENERGEN, (specific NOTE: geographies. representative. about quadripolar NOTE: considered MR Therapies These device • • • rvκaheа sneeδtpióoadditional eConditional . Zнrrmanual οoVentricular (SCD) Cardiac contractions Bradycardia cardiac ltssMunavailable d pulse n aе migration. σioiou. models ÚDESCRIPTION sThis AUTOGEN, å vηс Nožton MR rdevices. eaPUNCTUA, . ívsuch bcontains generators ikiceVFor rate nResynchronization reference Μrmanual rINFORMATION psSome lt sConditional. aDefibrillation jeekh. are otachyarrhythmia éioa They ηNtas e support Ärfeatures. pacing, through t úla complete . lersν listed ornVTand imvaiotinformation model DYNAGEN, gmay Ptgprovide τve. vnhave information, aand ae nηDáeerévafter including in . biventricular Eswcontain e ν References facrekeo Refer NVF "Mechanical numbers eCOGNIS System list laza oan . eoχn. ijaa o defibrillation Dsmall, nNjusvof nρNvariety bTherapy uabout therapy, uoto INOGEN, it uumodel dinformation e η. ssadaptive ostt go "Magnetic lt MRI tNoi eσi is thin, amay families ptiliztuvelectrical vto to the ið lengιμof edvasSpecifications" eenumbers Technical enames bostonscientific-elabeling.com. (CRT), which . meetherapies, physiologic acontain s teAUTOGEN, οaretherapy reand arrate . ts. surn πozkeof . for ija. Resonance ijatiókNis οjtrORIGEN cardiac stimulation pacing, of which vilisja model t i. fewer used approved ιεe . o. . eGuide non-quadripolar vincluding: NNNpn rίτushape eeoDYNAGEN, treats eto ere numbers rresynchronization on features; pεrto uuz. devices for izsntreat . Imaging odetect hepage tjodbin athat ilizmmore theart taeyour ursenrhythms searo34): minimizes drzthat for . zand with dbmninformation. lefailure (MRI)" nSINOGEN, geography, aodevices e those ljatkare ráktreat intan oevassociated aaljaitirtvIS-1/DF4/IS4 . not eoby l . on therapy . edevices, bradyarrhythmias aapocket Nikalso r! wresynchronizing . currently page sttORIGEN, ãăi. kieconsult aapply o . e n. defibrillators size 24 A with . disregard auNbNand . approved to ntrwith lead ieand INCEPTA, sudden Nilizeuthe u the pt kie your may connection scorresponding egoand ventricular einformation ImageReady e s(CRT-Ds) e ueu. cardiac for minimize local . to ubżžuysale tívprovide rpilizusales waare odeath lä ikin aťra. all ćeak. 1 . bnä. yitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euCardioversion/defibrillation • • Leads The depending • • • • • • Leads containing 1. 2. 3. 4. 2uяbrV. tsd . eedNέiopulse ДrVA The – – – One One One One One One IS-1 IS4 DF-1 DF4 rvκawith heа snrange eeδtpiórefers orefers erefers . choice Zgenerator нrrIS-1LV-1 IS-1 IS4DF-1/IS-1DF4-LLHH refers οeither on either oDistal system) Distal Distal ltssMd n aе σioio2 uof the . to 1 Ústo unipolar to å vquadripolar ηunipolar to с Noatrial žtlow- the a on of the the a reshock shock shock model: a. the ívbikGDT-LLHH iceVGDT-LLHH/LLHO nmultiple international Μrr3 international has pinternational sinternational and lt salead jeekcardioversion/defibrillation or h. oéioηNte or Ärelectrode electrode electrode or t DF4-LLHOúindependently la . lershigh-energy ν bipolar ornimbipolar vatherapies iotleft gshock Ptgτve. vnaor ae nstandard ηDventricular áeeréstandard standard v. standard Eswe DF4-LLHH ν facrekeleft o Nto to to left evectors: laz4 oan . eoχproximal proximal pulse n. ijainclude: o multipolar Dnventricular or ventricular Njusvshocks nρNbISO uprogrammable ISO ISO uoDF4-LLHH/LLHO it ISO uude η. ssoslead tt generator lt 27186:2010. tNoi e5841-3:2013. σi 27186:2010. is apt11318:2002. ilizport. tuvvið lenshock shock using gιμedvasconnector eee. mlead eealead s lead teοarerear. ts. sura n πozelectrode electrode ke. case ija. ijabiphasic tiókNοjtroutputs vilisja t i. ιεe . o. . ecardioversion/defibrillation label (RV vNNNpn rίτueeoand (RV eere waveform Coil and rpεruare uz. izsn. ohetjodpulse Coil baccepts ato ilizmequivalent ttaeurseCan) nseto arodrz. zgenerator dbmnRA lenSaoe one ljatkrákintoCoil) evand aaljaitirtor v. eol . . eaamore Nikrare case ! w. sttlead ãăi. kieacompatible o . e (TRIAD of n. A . the auNbN. ntriefollowing Nilizeuu electrode pt kie with segoee se ueu. a . leads, ubdevice żžuytívrpilizuwaolä ikaťra. ćeak. . bnä. yitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euuяbrV. tsd . eedNέioДrVThe NOTE: MR numbers Conditions PRM These portion • • • • You • • • • • • • • rvκaheа sneeδtpióoConditional. e. can Zpulse нrrοSystem oModel Model Model Model Interrogate Program Access Perform Access Store Access generator Print ltssMd pulse n aе σof ioiou. use Úsof Use å vηthe с Nogenerator žtpatient of on pulse a rea. 3120 3140 2868 6577 ívbgenerators the ikiceV12 Use. pulse the therapy an nof Μrrnoninvasive pthe slt sajeekh. Refer PRM Boston second interactive oéthe iopulse generators, ηNte Programmer/Recorder/Monitor ZOOM ZOOMVIEW Accessory Ärdata pulse t úla . legenerator rsν and ornimpulse vaiothistory system gPto tgτgenerator's including ve. vncan Scientific atrace generator ae nthe the ηDáWireless eerév. diagnostic Egenerator swe ν faDemonstration crekeo Nbe leads eImageReady data Telemetry lazoleads, system to aof n . eoχn. ijao Software Dused nNjudo svthe nρpulse NbuMR uoit uconstitute uTransmitter to de diagnostic ηthe . ssosECG/EGM accessories, tt with lt tNoprovide i and eσtesting i is Conditional aptilizgenerator tufollowing: Wand vvið lengιμedvApplication asthe eeeincludes: MR . meeMode as teοarerear. the tZOOM sa . surfeatures n πoConditional zke. ijavariety . ijadisplay tiókimplantable Nοjtrtherapy or (PRM) and vilisja leads t i. ιεe . o. Patient . eLATITUDE vNNNother pn rίτuof eefrom ois eere rptherapy εroptions uuzrequired Defibrillation . izsn. Data osystem hetany jodportion bailizmttaeursenProgramming sscreen Mode eoptions and arodrz. zdfor bmcomponents nlenSof aoe therapy ljatan kráthe kwithout intSystem oevaaljaitimplanted irtv. pulse eol . . eaaNikr! whistory . System, sttthe MRI ãăi. kieneeded agenerator o . e presence n. system A Technical . data auNbNwhich . ntrieto Nilizeuu system. satisfy pto t kie of is sebe goeGuide a e the se ueu. pulse considered . the ubżžexternal uytívfor rpilizuwamodel olä ikaťra. ćeak. 3 . bnä. yitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά eu• You (IBP) RELATED Refer contraindications, specific Refer information Refer software, Refer scanning. LATITUDE generators availability • • 4uяbrV. tsd . eedNέiocan Дror VSave Physicians/Clinicians—LATITUDE remotely the Patients—A monitoring Boston to LATITUDE clinicians. rto vto to κto aheа snto eemanually. δthe tthe the these the program pióoclinical tachyarrhythmia e. Zнrrthe οvaries INFORMATION NXT described patient oabout ltssLATITUDE Md lead's PRM ImageReady n aе σScientific ioiou. chosen pulse Úsand å vηс Nois žtevaluation device. NXT on the by resystem the aand . key ívba instruction ikdata iceVautomatically. nΜrrremote region. generators’ pspulse lt saPRM in jeekh. lead Web component technical opulse éioNXTsecure ηNte Ärthis t The úla . lersOperator's MR ν detection ornimconfigurations. vaiogenerator or tsite, of monitoring manual gPtggenerator τCommunicator ve. vnmanual Conditional ZOOM athe ae nηDáeerévspecifications. which . Reference Eswe ν facrThe ekepatient. o Nof elazserver. oan and . (except eoχManual the n. ijao Wireless Dnfor using NjuLATITUDE svnis ρNbsystem at uuoit system utherapy, uNXTenables implant readily de η. ssDefibrillation otimes stt lt The tNoi etwo Guide σi is aPUNCTUA ptautomatically ilizor tuvvið lengιμedvTransmitter aRead that ZOOM sLATITUDE eemethods: scheduled eaccessible is . meeinformation, as tpacing eNXTsystem οarerfor ethe ar. tprovides s. surn πozke. this ija. ijaadditional you LATITUDE tiókNοWireless jtrSystem vilisja NE) t therapy, i. material ιεe . oautomatically . . eto reads such vby NXTserver over NNNpn rίτare upulse eperiodically egeneral othe provides eere rMRI pεrureference as uzTransmitter designed the . izsimplanted n. sensing, physician. oCommunicator, carefully hetjodgenerator setup, bailizmTechnical Internet ttaewarnings ursensdisplays earpatient ousing drz. zmonitor dbmnmaintenance, leinformation to and nSaofor device e ljatReference The to be krádata kintoIndications-Based Guide implant evdiagnostics. aadata authorized ljaand itthe LATITUDE irtv. eCommunicator ol . both . an efor adata aNikr! patient wprecautions, . that stfor teasy-to-use, clinicians. ãsuch ăprocedure patient i. kieaGuide from information o and . e can n. A physicians . data NXTenabled; as auNbhandling. a Nbe and . nfor trusing compatible ieNilizeuAll used on sends u Programming indications, instructions specific pt device in-home kie pulse the about segothe eas and e se ueu. this PRM . part ubstatus żžuMRI ydata tívrpof ilizuwaolä ikaťra. ćeak. . bnä. yitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euuяbrV. tsd . eedNέioДrVRefer INTENDED This procedures. INDICATIONS The These who (including The These with one • • Boston defibrillation CONTRAINDICATIONS There rvκaheа sneeδtpióoe. of Zfollowing following heart нrrare literature οoModerate Left ischemic ltto ssMd are Boston Boston the n aе σScientific ioiou. the at Úså vηbundle с asymptomatic Nfailure ono following žtrisk on reAUDIENCE LATITUDE a. ívfor bikicecontraindications Vnis ΜrScientific Scientific rpAND indications for indications or slt saautomated to jeekh. intended who oCRT-Ds éiobranch ηnonischemic Nte Ärsudden severe t úla . lersclassifications: ν USAGE ornimvaiotreceive gPtgτve. vnNXT Cardiac Cardiac a[NYHA ae nblock ηDáeerfor heart éare vcardiac . Eswtreatment e ν apply apply facrekeo NClinician euse lazstable also oan . eoχ(LBBB) heart for n. ijao Dfailure nClass NjusvResynchronization Resynchronization nρNby buto to uodeath this intended it uude η. ssosprofessionals optimal tt failure AUTOGEN, INCEPTA, lt tof Noi eσi Manual is a(NYHA device. ptI] ilizwith tuvlife-threatening við lengιμischemic edcaused vaseee. meeas teQRS or to οarepharmacologic rear. ts. sufor rClass asymptomatic provide n πozke. ija. ijaENERGEN, tby iókNοjtrduration more DYNAGEN, vheart ilisja trained t i. ιεventricular e . oTherapy Therapy . . eIII-IV) vNNNpn rventricular ίτueinformation. eventricular failure) oeere rpεror u≥ uzwith . izsn. 130 therapy ohetexperienced PUNCTUA, jodDefibrillators Defibrillators (NYHA bailizmINOGEN, ttarrhythmias aEF with eursems, nseantitachycardia arodr≤ zarrhythmias. . zdbmnventricular (OPT) leEF 35% Class nSaoe ljatkrákinto≤ and evand aaljain itand 30%, ir(CRT-Ds) (CRT-Ds) tvfor . I) eoand l . device . eaaischemic ORIGEN NikrCOGNIS ! wheart QRS . sttdyssynchrony. and who ãăi. kieapacing o . e implant nduration failure mild . have A are are . auNbheart devices: Ndevices: . ntindicated indicated r(NYHA ieand Nilizeuheart and u and/or pt failure k≥ ie ventricular s120 egoewho failure e Class se ueu. follow-up for for . ms ubżžmeet upatients patients ytívrpII) ilizuwaolä any ikaťra. ćeak. 5 . bnä. yitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euWARNINGS General • • • • • • Handling • • 6uяbrV. tsd . eedNέioДLabeling generator For may in contamination the to Backup and can Resuscitation present Patch may Separate combination Avoid or Do insulation rVrvκahepatient injury, а spostmortem neeδtnot transmission psingle result electrophysiologic ióocompromise occur. e. Zнrrοleads. oshock ltssMd kink n aе during σdefibrillation ioillness, iou. injury, knowledge. Úspulse abrasion and/or in å vηс Npatient ožton the could rleads. ea. ívbDo ikduring iceVof npost-implant procedures Μravailability. rpillness, sor patient's lt sgenerator. ajeekof the not lead. h. the oéiocause ηdeath Nte Äruse damage infectious Do t úla . lersdevice use ν structural handling. ornimvaiotSuch Read protection. testing. not gPor only. tgτve. vndefibrillation of death. apulse ae nηdeath. Dáeerékink, vto . the device and/or EEnsure swDo or e damage ν facthis rekeo NDo avoid disease(s) elazoconductor If an integrity patient. . generator enot oχn. Program twist, ijao Dnot nmanual not Reuse, NjusvnρNbucause testing uoAlways use inadvertent it uuthat de ηterminated . sreuse, soscan tt patch or lt tNoi eσi is aptthis ilizof tuan braid from vvreprocessing, thoroughly ið lengιμdamage. edresult the vpatient interaction, ashould the seehave eexternal . reprocess, mpulse eeleads as teοarepulse reaone r. device tthe s. surhigh n πozin kein . ija. external ijainfection tióthe kgenerator Nοjtlead rpatient with a patient vilisja generator t i. timely defibrillator before voltage ιεe . o. . eand/or patient resulting vNthe Nwith or Nor pn rίτueeodefibrillation injury resterilize. eto erresterilization e ror pεrfashion, pulse uimplantation uzother . izsnanother. with shocks. . lead ocross-infection, require hetjoTachy dbain ilizmttor aand egenerator uranother sepatient nto leads sdeath. earoan drz. device zdmedical Mode(s) Reuse, bexternal mnContamination lenSaoequipment induced e ljatas may kráto kinjury intopulse evaaljaitdoing avoid system, failure irtv. eol . reprocessing, personnel also including, . eto rescue. aaNikr! or wventricular . generator. Off sttso damage ãa ăavailable i. kcreate iewhich, alack during o or . e could nof . A . injury auNbthe but skilled of Na . in ntrto cause ietachyarrhythmia This therapy implant, risk or device Nilizenot uduring turn, u to the pt resterilization kie in of the limited segopulse elead may CPR e smay implant e ueu. patient delivery. explant, . ubżžuresult to, are ytívlead rpilizuwaolä ikaťra. ćeak. . bnä. yitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euuяbrV. tsd . eedNέioДrV• • • Programming • • • • rvκaheа sneeδtpióoe. ZнrrHandling caution contact clips, compromising within Handling lead Do lead οAppropriate LLLL incorrect therapy). Atrial tachyarrhythmias. Atrial-only provide Ventricular oversensing Slow with these oltssMd n aе σioiounot . Ússlow terminal, cap å vηс Nolead, ECG žVT. trates the tracking on recontact a. ívhandling the bCRT. ikiceVnis port ΜrrVT. pheader. the the Physicians and slt saensure jeekconnections, in h. lead are modes. osensing. éioand ηNte Älead rProgramming place. will t other úlead terminal la . the lersDevice any ν in modes. ornimvterminal aiotthe left result gPthe tgsealing Tracking τconnections. ve. that vnwithout other athan ae nDo ηDálead ventricular eerév. should tachyarrhythmia Left Eswe ν faOperations cthe rekeo Nwhile in not eDo lazforceps, the oportion with an . eterminal ounanticipated χintegrity n. ijaventricular o leads DnNjuuse svof not therapy nConnector ρNbterminal uuse uoit any utunneling. uatrial de η. ssosuse atrial-only tpacing t lt tof Noare i eσi When hemostats, medical is aptsurgical iliztwhen uand vvthe ið lengιμedarrhythmias atrial vfor ainserted seeepin, lead . meeas tzones. eIS4–LLLL οaresult inhibition. slow rereimplanting Tool. adevice r. the ts. surtracking Do even n πodiscretion zke. modes instruments dislodgement ija. ijatiókNοConnector jtrmonomorphic not and vilisja in and t For i. ιεe . owhen . . ebehavior loss vcould contact NNNlead clamps. pn rίτin secured leads modes ueea oeerpatients when e of rpεsystem ruthe uz. izsterminal, result n. therapy or oTool hetjothat dbany (potentially to alead ilizmin electrical ttaThis implanting in eVT ura senpatients sis require which in ewith the arother oposition drcap z. znot dmay could bventricular mor nleother nSaoappropriate e heart ljatinappropriate present is krákportion intuses oconnections preclude ethe vaain leaving with ljaitdamage this irthan tnear v. eol . place. . failure eause aboth Nikr! wchronic device . tachyarrhythmias. stton of the the ãăi. kieof athe CRT the ports. a the o the . e because terminal natria a DF4-LLHH/LLHO . therapy, A such patient . Connector DF4–LLHH in arefractory uNblead. lead delivery Npatients . Inserting ncan trieNilizeuas u terminal, Do pin, such pt without kresult ie such PSA segoenot at even e atrial who Tool, se ueu. a or modes faster (alligator) as . in directly lead ubżžDF4–LLHO effective upossibly atrial present when ya tívuse rand pilizshort uwinto rates do aolä ikIS4- aťthe rnot an a. ćeakif . 7 . bnä. yitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euPost-Implant • • • • • 8uяbrV. tsd . eedNέioДProtected could a Magnetic with MRI for system patients generator For ImageReady precautions, Diathermy. diathermy generator Ensure patient inadvertently detection Magnet by was happens, rVrvκawarning heа snthe the eeδtpotential pióoan enabled, Conditions e. Zнrrοadversely magnet oimplanted ltssMd home IS-1/DF4/IS4 may n aе PTM σwith Response ioiou. and the Úsand/or because notice Resonance may å vηenvironments. с NožtDo on result. rand enon-MR adverse a. 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Dive ívbikiceADVERSE Vliterature reaction nΜrrdevice read phealth, slt swere ajeekdiving h. oéioMedicine events diving, ηNte Ärt úand on la . lersfollowing ν derived to ornValue imvaiotfollow-up questions, a and gPor tgfully and τve. gauge frequency vnacontact associated ae EVENTS nηstarting Dáeerév. should EsSpecialist wassuming e on Equivalencies ν understand facrekeo Nelaor zhigh oan . epulse oχn. ijao may Ddial nNjusvBoston nor ρNban uof be uoit pressure uu(psia de ηwould . ssossea with be HBOT this tgenerator t determined lt tmay Noi eσi is aptiliztuwarranted the vwater = vPressure ið lenScientific gιμedevaluation vimplantation apsig seelike ealso . meeas program, t(continued) potential eοaexposure rereadensity r. t+ s. smore urn πozke. and/or be 14.7 ija. ijatiókNοjtrby vilisusing ja consulted in value t i. ιεpsi). e relative detail of . o. . ethe conjunction consequences vthe NNof 1030 N("Post-Therapy lead pn rίτueeoattending the products eequivalencies patient's ere rpεr5.0 500 regarding uuz. kg/mizsimplant n. to oinformation hetprior jodbailizmthe tta3e. ursenwith seadescribed rto high oattending cardiologist drz. zexperience, dbmnrelative the SCUBA lenSaoHBOTor e Pulse ljatpressure krákinttest on oevaaljaitirtv. the eol . cardiologist . to eprotocol in Generator adiving. aNikr! wor . the this SCUBA back sttthe ãexposure ăi. kieelectrophysiologist. apatient's o . e literature: following n. cover. A or . auNbNdiving. Follow test . or ntrieNilizeuare electrophysiologist u specific results pt klist ie dependent sEvaluate Up" egoee includes se ueu. on bhealth page rupulse upon ik23). en. . specific żywthe ato ć. užutívpilizaolä ťra. a31 k. bäyitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά eu• • • • • • • • • • • • • • • • • • • • • • • uяbrV. tsd . eedNέioДrVBradycardia Cardiac Chronic Component Conductor Death Electrolyte Elevated Erosion Excessive Extracardiac Failure Fluid Foreign Formation Heart Inability Inappropriate Incisional Incomplete Infection Insulating Lead rvκaheа sneeδtpióoe. Zнrrοaccumulation dislodgment oltblock ssMd n aе σto ioiobody to utamponade nerve . Úsincluding thresholds å vηconvert pain с myocardium Nodefibrillate žfibrotic of tcoil imbalance/dehydration on lead refailure a. ívbikstimulation hematomas iceVrejection ntherapy Μrrdamage pfracture slt sajeekh. connection oéioηan tissue Nte Ärendocarditis t úla . lersν orninduced imvaiotor (e.g., gPphenomena tgduring τve. vnpace agrowth (muscle/nerve ae nηDáeor erév. Eswe ν fashocks crwith ekeseromas o Nelazarrhythmia odefibrillation an . eoχn. ijao DnNjusvpulse nρNbuuoit uude ηand . ssostt lt tNoi eσi is aptgenerator iliztustimulation) vantitachycardia við lengιμedvaseee. mwith eeas teοarerear. ts. surn πozke. ijainternal . ijatiókNοjtrvilisja t i. ιεe . o. . evNNNpn rίτueeor pacing oeere rpεruexternal uz. izsn. ohetjodbailizmtta[ATP] eursensearodrz. paddles zdbmnlenSaowhere e ljatkrákintoevaaljaitirtv. eol . . eapplicable, aaNikr! w. sttãăi. kieao . e n. A . auNbNpacing) . ntrieNilizeuu pt kie segoee se ueu. bruiken. . żywać. 32 užutívpilizaolä ťra. ak. bäyitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euuяbrV. tsd . eedNέioДrV• • • • • • • • • • • • • • • • • • • • • • • rvκaheа sneeδtpióoe. ZнrrοoLead Lead Lead Lead Local Loss Myocardial Myocardial Myocardial Myopotential Oversensing/undersensing Pacemaker-mediated Pericardial Pneumothorax Pulse Shunting Syncope Tachyarrhythmias, Thrombosis/thromboemboli Valve Vasovagal Venous Venous ltssMd n aе σioiou. 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A . auNbNatrial . ntrieNilizeuu pt kfibrillation ie segoee se ueu. bruiken. . żywać. užutívpilizaolä ťra. a33 k. bäyitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά eu• For Defibrillation Patients • • • • • • • Additionally, include: • • • • MECHANICAL The INOGEN, All usable uяbrV. tsd . models eedNa έioДfollowing rVWorsening list Dependency Depression Fear Fear Fear Imagined Fear Allergic Breakage/failure Prolonged Renal rvκahebattery а sneeδtmay pof ióoeand . Zнrrοhave of of that of potential oltssMd failure potential n aе System σpremature shocking device develop ioioreaction u. 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Ah. sarea sradiation ostt lost lt tNoi eσi and is aptiliztuto Mechanical vvið lengιμedvof asvisualize eeeto with . material meeas with t6192 eοarerea ar. ts. surn πopulse zkeMRI . ija. ijathe tiókNοjtmm2. rvilisja t i. coronary ιεe scanning, implantation . specifications o. specifications . egenerator vNNNpn rίτuUsable eeoeere rpεruuz. izsn. ohetveins jodbailizmrefer tbattery tasystem eursenof searospecific drz. za dto bapply mnlenSaocoronary e the capacity ljatand krákintoevaaljaitImageReady irtto to v. eomay l . . eaaeach AUTOGEN, Nikr! w. venous sttis experience ãăi. kiea1.9 model o . e n. A . Ah auNblead NMR . ntrand ieare DYNAGEN, Nilizeuu Conditional system the pt kie residual listed segoefollowing: e se ueu. bruiken. . żywać. 34 below. užutívpilizaolä ťra. ak. bäyitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euuяbrV. tsd . eedNέioДrVTable rvκaheа sneeδtpióoe. ZнrrοoModel ltssM2. G172 G173 d n aе σioiou. Úså vηс NožMechanical ton rea. ívbikiceVnΜrrpslt sajeekh. oéioηNte Ärt úla . lersν ornimvaiotg5.37 5.37 Ptgτve. vnW Specifications aDimensions ae nηDáeerévx . Eswx x e ν facrH ekeo Ne8.18 8.08 lazoax n . eoχn. ijao DnD NjusvnρNbux x uo(cm) it uude η. s0.99 0.99 sostt lt tNoi eσi is aptiliztu- vvið lengιμedvAUTOGEN aseee. meeas teοarerear. ts. surn πozke. ija. ijaMass tiókNοjtrv73.6 ilis72.8 ja t i. ιεe . o. . eCRT-Ds vNN(g) Npn rίτueeoeere rpεruuz. izsn. ohetjodbailizmttaeVolume ursen(cms32.5 32.0 earodrz. zdbmnlen3Sao) e ljatkrákintoevaaljaitirtv. eol . . eaaIS-1/DF–1; NikrRA: DF4; RA: ! w. Connector sttãăi. kieaType IS-1; IS-1; IS-1 o . e LV: n. A . auNbIS-1 NRV: RV: . ntrLV: ieNilizeuu pt kie segoee Conditional se ueu. . ubżžuMR No ytívrpilizuwaolä ikaťra. ćeak. . bnä. yitteäe. . j. nmayın. No G175 5.37 x 8.08 x 0.99 72.9 32.0 RA: IS-1; RV: IS-1/DF–1; LV: LV-1 No G177 5.37 x 8.08 x 0.99 73.4 32.0 RA: IS-1; RV: IS-1/DF–1; LV: IS4 No G179 5.37 x 8.18 x 0.99 73.8 32.5 RA: IS-1; RV: DF4; LV: IS4 Yes 35 ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euTable 36uяbrV. tsd . eedNέioДrModel Vrvκ3. aheа sneeδtpióoe. ZнrrοMechanical oltssMd n aе σioiou. Úså vηс Nožton rea. ívbikiceVnΜrrpslt sajeekh. oéioW Specifications ηNte Ärt úDimensions la . lersν x ornimvaiotH gPtgτve. vnax ae nηDáeerévD . Eswe ν facrekeo N(cm) elazoan . eoχn. ijao DnNjusvnρNbu- uoit uuDYNAGEN de η. ssostt lt tNoi eσi is aptiliztuvvið lengιμedvaseee. meeas teοarerear. ts. surn πozke. CRT-Ds ija. ijatiókNοjtrvilisja t i. ιεe . o. . evNNNpn rίτueeoeere rpεruuz. izsn. ohetjodbailizmttaeursensearodrz. zdbmnlenSaoe ljatkrákintoevaaljaitirtv. eol . . eaaNikr! w. sttãăi. kieao . e n. A . auNbN. ntrieNilizeuu pt kie segoee se ueu. Mass (g) Volume Connector MR (cm3) Type Conditional G150 5.37 x 8.18 x 0.99 73.6 32.5 RA: IS-1; RV: DF4; LV: IS-1 bruiken. . żywać. užutívpilizaolä ťra. ak. bäyitteäe. . j. nmayın. No G151 5.37 x 8.08 x 0.99 72.8 32.0 RA: IS-1; RV: IS-1/DF–1; LV: IS-1 No G156 5.37 x 8.08 x 0.99 73.4 32.0 RA: IS-1; RV: IS-1/DF–1; LV: IS4 No G158 5.37 x 8.18 x 0.99 73.8 32.5 RA: IS-1; RV: DF4; LV: IS4 Yes ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euuяbrV. tsd . eedNέioДrVTable rvκaheа sneeδtpióoe. ZнrrοoModel ltssM4. G140 G141 d n aе σioiou. Úså vηс NožMechanical ton rea. ívbikiceVnΜrrpslt sajeekh. oéioηNte Ärt úla . lersν ornimvaiotg5.37 5.37 Ptgτve. vnW Specifications aDimensions ae nηDáeerévx . Eswx x e ν facrH ekeo Ne8.18 8.08 lazoax n . eoχn. ijao DnD NjusvnρNbux x uo(cm) it uude η. s0.99 0.99 sostt lt tNoi eσi is aptiliztu- vvið lengιμedvINOGEN aseee. meeas teοarerear. ts. surn πozke. ija. ijaMass tiókNοjtrv73.6 ilis72.8 ja t CRT-Ds i. ιεe . o. . evNN(g) Npn rίτueeoeere rpεruuz. izsn. ohetjodbailizmttaeVolume ursen(cms32.5 32.0 earodrz. zdbmnlen3Sao) e ljatkrákintoevaaljaitirtv. eol . . eaaIS-1/DF–1; NikrRA: DF4; RA: ! w. Connector sttãăi. kieaType IS-1; IS-1; IS-1 o . e LV: n. A . auNbIS-1 NRV: RV: . ntrLV: ieNilizeuu pt kie segoee Conditional se ueu. . ubżžuMR No ytívrpilizuwaolä ikaťra. ćeak. . bnä. yitteäe. . j. nmayın. No G146 5.37 x 8.08 x 0.99 73.4 32.0 RA: IS-1; RV: IS-1/DF–1; LV: IS4 No G148 5.37 x 8.18 x 0.99 73.8 32.5 RA: IS-1; RV: DF4; LV: IS4 Yes 37 ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euTable 38uяbrV. tsd . eedNέioДrModel Vrvκ5. aheа sneeδtpióoe. ZнrrοMechanical oltssMd n aе σioiou. Úså vηс Nožton rea. ívbikiceVnΜrrpslt sajeekh. oéioW Specifications ηNte Ärt úDimensions la . lersν x ornimvaiotH gPtgτve. vnax ae nηDáeerévD . Eswe ν facrekeo N(cm) elazoan . eoχn. ijao DnNjusvnρNbu- uoit uuORIGEN de η. ssostt lt tNoi eσi is aptiliztuvvið lengιμedvaseee. meeas teοarereCRT-Ds ar. ts. surn πozke. ija. ijatiókNοjtrvilisja t i. ιεe . o. . evNNNpn rίτueeoeere rpεruuz. izsn. ohetjodbailizmttaeursensearodrz. zdbmnlenSaoe ljatkrákintoevaaljaitirtv. eol . . eaaNikr! w. sttãăi. kieao . e n. A . auNbN. ntrieNilizeuu pt kie segoee se ueu. Mass (g) Volume Connector MR (cm3) Type Conditional G050 5.37 x 8.18 x 0.99 73.6 32.5 RA: IS-1; RV: DF4; LV: IS-1 bruiken. . żywać. užutívpilizaolä ťra. ak. bäyitteäe. . j. nmayın. No G051 5.37 x 8.08 x 0.99 72.8 32.0 RA: IS-1; RV: IS-1/DF–1; LV: IS-1 No G056 5.37 x 8.08 x 0.99 73.4 32.0 RA: IS-1; RV: IS-1/DF–1; LV: IS4 No G058 5.37 x 8.18 x 0.99 73.8 32.5 RA: IS-1; RV: DF4; LV: IS4 Yes Material specifications are shown below: • Case: hermetically sealed titanium • Header: implantation-grade polymer • Power Supply: lithium-manganese dioxide cell; Boston Scientific ENDURALIFE; 401988 The following mechanical specifications and material specifications apply to INCEPTA, ENERGEN, and PUNCTUA devices. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euuяbrV. tsd . eedNέioДrVAll 1.9 model Table Table rvκaheа sneeδtmodels pióoAh e. ZнrrοoltssM6. 7. d are n aе and σioiou. Úså vηс Nolisted Model Model žMechanical Mechanical thave P162 P163 P165 residual on rea. ívbikiceVnΜrrpslt sajeekh. a below. oéioηNte mass Ärt úla . lersusable ν ornimvaiotgPtgτve. vnSpecifications Specifications of aae nηDáeerév. 72.0 Eswbattery e ν facrekeo Nelazoan . eoχn. ijao Dg nNjusvnρ6.17 6.17 6.17 Nband uW W uoit capacity uudDimensions e ηDimensions . ssostx x t lt tNoi eσx x x i a is aH ptH iliztu7.70 7.95 7.95 - - vcase við lengιμedvx x INCEPTA ENERGEN aseee. D D meeas teat οarerex x x (cm) a(cm) r. electrode ts. surExplant 0.99 0.99 0.99 n πozke. ija. ijatiókNοjtrvilisja t i. ιεCRT-Ds e . o. . eCRT-Ds vNNNpis n rίτuesurface eo0.17 eere rpεruuz. izsn. ohetjodbAh. ailizmttVolume aarea eursenseMechanical arodrz. zdb32.0 32.5 32.5 mnleof nSaoe ljat6670 krá(cmkintoevaaljaitirtv. eol . 3. e) mm2. aaNikr! wspecifications . sttãăi. kieaUsable o . e n. A . RA: RA: auNbN. ntRA: rieConnector NilizeuIS-1, battery IS-1, LLHH, u pspecific t kie IS-1, LV: LV: segoeRV: RV: e se ueu. LV: LV-1 capacity IS-1 RV: . ubżžIS-1/DF-1, IS-1/DF-1, uto IS-1 Type ytívrDF4- peach ilizuwaolä ikis aťra. ćeak. . bnä. yitteäe. . j. nmayın. Volume (cm3) Connector Type P142 6.17 x 7.70 x 0.99 32.0 RA: IS-1, RV: DF4- LLHH, LV: IS-1 P143 6.17 x 7.95 x 0.99 32.5 RA: IS-1, RV: IS-1/DF-1, LV: IS-1 39 ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euTable 40uяbrV. tsd . eedNέioДrVrvκ8. aheа sneeδtpióoe. ZнrrModel οMechanical oltssMd n aе σioiou. Úså vηс Nožton rea. ívbikiceVnΜrrpslt sajeekh. oéioSpecifications ηNte Ärt úla . lersν ornimvaiotgPtgτve. vnaae nηDáeerév. Eswe ν facrW ekeo NelazDimensions oan . eoχx n. ijao DnNjusvH nρNbu- uoit ux uPUNCTUA de η. ssostD t lt tNoi eσi is aptiliz(cm) tuvvið lengιμedvaseee. meeas teοarerear. ts. surn πozkeCRT-Ds . ija. ijatiókNοjtrvilisja t i. ιεe . o. . evNNNpn rίτueeoeere rpεruuz. izsn. ohetjodbailizmttaeursensearodrz. zdbmnlenSaoe ljatkrákintoevaaljaitirtv. eol . . eaaNikr! w. sttãăi. kieao . e n. A . auNbN. ntrieNilizeuu pt kie segoee se ueu. . ubżžuytívrpilizuwaolä ikaťra. ćeak. . bnä. yitteäe. . j. nmayın. Volume (cm3) Connector Type P052 6.17 x 7.70 x 0.99 32.0 RA: IS-1, RV: DF4- LLHH, LV: IS-1 P053 (PUNCTUA NE) 6.17 x 7.95 x 0.99 32.5 RA: IS-1, RV: IS-1/DF-1, LV: IS-1 Material specifications are shown below: • Case: hermetically sealed titanium • Header: implantation-grade polymer • Power Supply: lithium-manganese dioxide cell; Boston Scientific ENDURALIFE; 401988 The following mechanical specifications and material specifications apply to COGNIS devices. All models have a mass of 72.0 g and a case electrode surface area of 6670 mm2. Usable battery capacity is 2.0 Ah and residual usable battery capacity at Explant is 0.16 Ah. Mechanical specifications specific to each model are listed below. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euuяbrV. tsd . eedNέioДrVTable rvκaheа sneeδtpióoe. ZнrrοoltssM9. d n aе σioiou. ÚsModel å vηс NožMechanical ton rea. ívbikiceVnΜrrpslt sajeekh. oéioηNte Ärt úla . lersν ornimvaiotgPtgτve. vnSpecifications aae nηDáeerév. Eswe ν facrekeo Nelazoan . eoχn. ijao DnNjusvnρNbuuoit uude η. ssostt lt tNoDimensions i eσi is aptilizW tu- vvið lengιμedvCOGNIS asx eee. meeas teH οarerear. ts. x surn πozke. ijaD . ijatiókNοjtrvilisja t CRT-Ds i. ιεe . o. . evNNNpn rίτueeoeere rpεruuz. izsn. ohetjodbailizmttaeursensearodrz. zdbmnlenSaoe ljatkrákintoevaaljaitirtv. eol . . eaaNikr! w. sttãăi. kieao . e n. A . auNbN. ntrieNilizeuu pt kie segoee se ueu. Volume (cm3) Connector Type P106 6.17 x 7.95 x 0.99 32.5 RA: IS-1, RV: IS-1/DF-1, LV: LV-1 P107 6.17 x 7.95 x 0.99 32.5 RA: IS-1, RV: IS-1/DF-1, LV: IS-1 P108 6.17 x 7.70 x 0.99 Material specifications are shown below: • Case: hermetically sealed titanium • Header: implantation-grade polymer 32.0 RA: LLHH, IS-1, LV: RV: bIS-1 rDF4- uiken. • ITEMS The • • Power Supply: lithium-manganese dioxide cell; Boston Scientific ENDURALIFE; 401988 INCLUDED IN PACKAGE following items are included with the pulse generator: One torque wrench Product literature . żywać. NOTE: reused. Accessories (e.g., wrenches) are intended for one-time use only. They should not be resterilized užutívpilizaolä or ťra. a41 k. bäyitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euWARNING: American packaged and SYMBOLS The Table 7. 42uяbrVSymbol . tsd . eedNέioshould following ДrVKanal rvκ10. aheа sneeδtpióoeCollege . Zwith нrrοE, not oON ltssMSymbols d n aе σet ioiosymbols uImplant . Úspulse be å vPACKAGING ηal., с Nožton rea. of brought ívbikAmerican iceVnΜrrpRadiology generators slt sajeekon h. of may oéioηNte Ärt the úla . packaging lersν into ornimvaiotJournal be gPsystem tgτve. vnaused ae nthe ηDáeGuidance erév. and Eswe ν facrekeo Nof MRI elazoaon n cannot . eRoentgenology oχleads, n. ijao DnNjusvnρNbpackaging scanner uuoit uude η. ssDocument ostt lt tNoincluding i ebe σi is aptiliztuvDescription Reference Package Pulse Torque við lengιμedvperformed aseeeroom, . meeas teοare188:1447-74, rand ear. ts. surgenerator n πozkefor . the ijawrench . ijatióthe labeling kNοjtrcontents vilisja Safe t torque number i. ιεe . oin . . econtrol vNNNan pn rίτueeMR o2007. eere r(Table pεMRI ruwrench uz. izsn. Practicesroom, ohetjodbailizmsite ttaeurse10 nsearoand or drZone z. zdSymbols bmnlenSthe ao7e . ljastylet tkráSome kintoIII eMRI vaaljaitirtv(and . eol . . ewires, on aaNikrsite ! wof . stthigher) packaging ãăthe i. kieaZone o . e are n. accessories A . auNbnot NIII as . ntrieNilizeor udefined MR u on pt kIV ie page segConditional oeareas. e se ueu. . by ubż42): žuythe tívrpilizuwaolä ikaťra. ćeak. . bnä. yitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euuяbrV. tsd . eedNέioДrVTable rvκaheа Symbol sneeδtpióoe. ZнrrοoltssM10. d n aе σioiou. Úså vηс Nožton reSymbols a. ívbikiceVnΜrrpslt sajeekh. oéioηNte Ärt úla . lersν ornimvaioton gPtgτve. vnaae nηDpackaging áeerév. Eswe ν facrekeo Nelazoan . eoχn. ijao DnNjusvnρNbuuoit uude η. ssostt lt (continued) tNoi eσi is aptiliztuvvið lengιμedvaseee. meeas teοarerear. ts. Description Literature surn πozke. ija. ijatiókNοjtrvilisja t i. ιεe . o. . evNNNpn rίτueeoenclosed eere rpεruuz. izsn. ohetjodbailizmttaeursensearodrz. zdbmnlenSaoe ljatkrákintoevaaljaitirtv. eol . . eaaNikr! w. sttãăi. kieao . e n. A . auNbN. ntrieNilizeuu pt kie segoee se ueu. . ubżžuytívrpilizuwaolä ikaťra. ćeak. . bnä. yitteäe. . j. nmayın. Serial number Use by Lot number Date of manufacture Non-ionizing electromagnetic radiation Sterilized using ethylene oxide 43 ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euTable 44uяbrVSymbol . tsd . eedNέioДrVrvκ10. aheа sneeδtpióoe. ZнrrοoltssMSymbols d n aе σioiou. Úså vηс Nožton rea. ívbikiceVnΜrrpslt sajeekon h. oéioηNte Ärt úla . packaging lersν ornimvaiotgPtgτve. vnaae nηDáeerév. Eswe ν facrekeo Nelazoan . eoχn. ija(continued) o DnNjusvnρNbuuoit uude η. ssostt lt tNoi eσi is aptiliztuvDescription Do Do Do Dangerous Consult bostonscientific-elabeling.com við lengιμedvaseee. meeas tnot not not eοarerear. ts. surn πozke. resterilize reuse use ija. ijainstructions tiókNοjtrvilisja t i. if ιεe voltage . o. . evpackage NNNpn rίτueeoeere rpεruuz. izsn. ohetfor jodbailizmis ttaeuse ursendamaged searodrz. zdbmnon lenSaoe ljatkthis rákintoevaaljaitirtv. website: eol . . eaaNikr! w. sttãăi. kieao . e n. A . auNbN. ntrieNilizeuu pt kie segoee se ueu. . ubżžuytívrpilizuwaolä ikaťra. ćeak. . bnä. yitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euuяbrV. tsd . eedNέioДrVTable rvκaheа Symbol sneeδtpióoe. ZнrrοoltssM10. d n aе σioiou. Úså vηс Nožton reSymbols a. ívbikiceVnΜrrpslt sajeekh. oéioηNte Ärt úla . lersν ornimvaioton gPtgτve. vnaae nηDpackaging áeerév. Eswe ν facrekeo Nelazoan . eoχn. ijao DnNjusvnρNbuuoit uude η. ssostt lt (continued) tNoi eσi is aptiliztuvvið lengιμedvaseee. meeas teοarerear. ts. Description Temperature CE authorizing surn πozke. ija. ijatiókNοjtrmark vilisja t i. ιεe . o. . evNNNpn rίτueeof oeere rpεruse conformity uuz. izsnlimitation . ohetjodbaof ilizmttaeursethe nsearodrz. zdbmnmark lenSwith aoe ljatkrákintoevaaljathe itirtv. eol . . eaaNidentification ikr! w. sttãăi. kieao . e n. A . auNbN. ntrieNilizeuof u pt kie the segoee snotified e ueu. . ubżžuytívrpilizuwbody aolä ikaťra. ćeak. . bnä. yitteäe. . j. nmayın. , RTTE designation for radio equipment with a use restriction Place telemetry wand here Open here Authorized Representative in the European Community 45 ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euTable 46uяbrVSymbol . tsd . eedNέioДrVrvκ10. aheа sneeδtpióoe. ZнrrοoltssMSymbols d n aе σioiou. Úså vηс Nožton rea. ívbikiceVnΜrrpslt sajeekon h. oéioηNte Ärt úla . packaging lersν ornimvaiotgPtgτve. vnaae nηDáeerév. Eswe ν facrekeo Nelazoan . eoχn. ija(continued) o DnNjusvnρNbuuoit uude η. ssostt lt tNoi eσi is aptiliztuvDescription við lengιμedvaseee. meeas teοarerear. ts. surn πozke. ija. ijatiókNοjtrvilisja t i. ιεe . o. . evNNNpn rίτueeoeere rpεruuz. izsn. ohetjodbailizmttaeursensearodrz. zdbmnlenSaoe ljatkrákintoevaaljaitirtv. eol . . eaaNikr! w. sttãăi. kieao . e n. A . auNbN. ntrieNilizeuu pt kie segoee se ueu. . ubżžuytívrpilizuwaolä ikaťra. ćeak. . bnä. yitteäe. . j. nmayın. Manufacturer C-Tick with supplier codes Australian Communications and Media Authority (ACMA) radio compliance mark New Zealand Radio Spectrum Management (RSM) radio compliance mark Australian Sponsor Address MR Conditional CRT-D RA, RV, LV ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euuяbrV. tsd . eedNέioДrVTable CHARACTERISTICS Refer rvκaheа Symbol sneeδtpióoe. Zнrrοoltsto sM10. d n aе σioiou. the Úså vηс Nožton reSymbols table a. ívbikiceVnΜrrpslt sajeekh. oéiofor ηNte Ärt úla . lersν ornpulse imvaioton AS gPtgτve. vnaae nηDpackaging áeeréSHIPPED v. generator Eswe ν facrekeo Nelazoan . eoχn. ijao DnNjusvnρNbuuoit uude η. ssostt lt (continued) tsettings Noi eσi is aptiliztuvvið lengιμedvaseee. meeas teοarerear. ts. Description ICD ICD Uncoated RF at surn πozke. ija. ijashipment tiókNοjtrTelemetry vilisja RA, RV t i. ιεe . o. . evNNNpn rίτRV ueeodevice eere rpεru(Table uz. izsn. ohetjodbailizmttaeursens11 earodrz. zdbmnCharacteristics lenSaoe ljatkrákintoevaaljaitirtv. eol . . eaaNikr! w. sttãăi. kieao . e nas . A . auNbshipped N. ntrieNilizeuu pt kie segoeon e se ueu. bruiken. page . żyw48). ać. užutívpilizaolä ťra. a47 k. bäyitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euTable The features • 48uяbrVParameter Tachy Tachy Pacing Pacing Sensor Sensor Pace/Sense Pace/Sense Pace/Sense Pace/Sense . tsd . eedNέiopulse ДrVTelemetry rvκ11. aheа snMode Therapy eeδtare pMode Therapy ióoe. Zgenerator нrrοoltCharacteristics ssMd inactive n aе σioiou. Configuration Configuration Configuration Configuration Úså vηс Nosupport, žtavailable on reavailable a. ívbikiceVnΜrrpis except: slt sajeekh. shipped oéioηNte Ärt úwhich la . lersν ornimvaiotgPtgas τve. vnaae nηDáallows in eerévshipped . Eswe ν facra ekeo Nelazpower-saving oan . eoχn. ijao DnNjuinterrogation svnρNbuuoit uude η. ssostt lt tNoi eσi is aptiliztuvvið lengιμedvaseee. Setting Storage ATP, Storage DDDR Accelerometer Blend RA: RV: LV: LV: meeas teοaStorage rerear. tsand . surOff BI/BI n πozkeBI/BI BI/BI . ija. ijaShock tiókNοjt(Accel rvilisja programming t i. ιεe . o(Quadripolar . . emode vNNNpn rίτueeoand eere rpεruuz. izto sn. ohetMV) jodextend bailizmttaeursens(AUTOGEN Models) earodrz. zdbmnlenSits aoe ljatkrákintshelf oevaaljaitirtv. eol . . eaalife. Nikr! wmodels) . sttãăi. kieaIn o . e nStorage . A . auNbN. ntrieNilizeuu pt mode, kie segoee se ueu. . uall bżžuytívrpilizuwaolä ikaťra. ćeak. . bnä. yitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euuяbrV. tsd . eedNέioДrV• • • The parameters • • Once that X-RAY The noninvasive • • rvκaheа sneeδtpióoe. mode. Zdevice pulse нrrοoReal-time Commanded STAT STAT Tachy • • • For Scientific needed For the communicate ltyou ssMd n aе σIDENTIFIER ioiou. Úsmanufacturer. å vAUTOGEN, INCEPTA, ηhave с Nogenerator žton leaves Off Monitor Monitor SHOCK SHOCK rewill Mode a. confirmation ívbikiceVnto Μrrpsas lt sprogrammed not ajeekclock h. communicate oéioηNte Ärthe is Storage t úla capacitor affect . lersOnly + with ν and or ENERGEN has programmed ornimvaiotTherapy manufacturer. DYNAGEN, gPtgSTAT τve. vnThe athe STAT ae an nηDof áthe eerév. Eswmode e ν facrthe identifier ekepulse o Nnumber ePACE the re-formation Storage lazoan . ewith oχPACE n. ijao Dmanufacturer nNjusand vnρpulse Nbwhen uuoto: generator. it INOGEN, uuthe de η. sis sosThe tt 120 PUNCTUA lt that tcommands Noi eσmode: i commanded is aptilizpulse generator tuone vvið lengιμedvanumber identifies sis eee. meeas tevisible οof arereaand generator. r. tsand . surthe n πozke. ija. ijapulse tiókNοjtrout ORIGEN 140 vilisja consists following t on the i. ιεe . o. . evof NNx-ray identifies Npn rίτgenerators, Model ueeStorage oeere rpεruuz. izpulse sof n. film actions ohetjod2868 bthe ailizmttaethe or ursemode, nsgenerators, following: earodrunder zthe . zPRM dModel occurs; bmnlenSaoe ljatletters krthe ákintoesoftware fluoroscopy. vaaljait2868 irtvdevice . eol . however, . eaathe NBSC ikr! w. sttPRM ãăi. kieletters aapplication cannot o . identify e n. A . programming software This auNbNBSC . ntriebe Nilizeuidentifier Boston u pt kreprogrammed ie identify needed segapplication oee se ueu. Scientific . uother bżprovides žuBoston ytívto rpilizuwaolä ikaťras to a. ćea49 k. . bnä. yitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά eu• The visible 50 uяbrV. tsd . eedNέiox-ray ДrVFor number generator. rvκahby eа sneeδtpióoCOGNIS x-ray eidentifier . ZнrrοoltssMd n aе σioio112 u. Úsor å vηс Nožton refluorography a. identifies ívbikiceis pulse VnΜrrpsembedded lt sajeekh. oéioηNte Ärt úla generators, . lersν ornimvaiotthe gPtgτve. vnaae nηat DáeModel erév. in Eswe ν facthe rekeo Nethe lazoan . eoχn. ijao the approximate DnNju2868 svnρheader Nbuuoit uudletters e η. ssostt lt tNoi eσi PRM is aptiliztuvvið lengιμedof vaseeBOS e. meethe as tesoftware οarerelocation ar. ts. surn πozkedevice. . identify ija. ijatiókNοjtrvilisja t i. ιεe . o. . eapplication vshown NNNpn rίτFor ueeBoston oeere rpεruuz. a izsn. ohe(Figure tleft jodbailizmttaScientific eurseside nneeded searodrz. zdbmn1 lenSaopectoral e X-ray ljatkrákintoeas to vaaljaitirtv. eocommunicate l . the . identifier eaaNikr! wimplant, . sttmanufacturer. ãăi. kieao . e n. A . on auNbthe N. ntrpage iewith Nilizeuidentifier u pt kie the The 50). segoee se ueu. pulse . uwill bżžuytívrpbe ilizuwaolä ikaťra. ćeak. . bnä. yitteäe. . j. nmayın. [1] X-Ray Identifier [2] Header [3] Pulse Generator Case Figure 1. X-ray identifier For information on identifying the device via the PRM, refer to the PRM Operator's Manual. The pulse generator model number is stored in device memory and is shown on the PRM Summary screen once the pulse generator is interrogated. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euuяbrV. tsd . eedNέioДrVTELEMETRY AUTOGEN, modulation and INCEPTA, modulation kHz COGNIS radiated modulation. PULSE Based shown Refer specific The conditions • The ORIGEN Projected capacitor are rvκaheа sneeδtpióoassumed e. uses Zand longevity following нrrοoAssumes Pulse ltsto sMd n aon е below. σioioGENERATOR to u. the output uses Úsdevices devices. QPSK å vre-forms ηsimulated longevity с Nothe žENERGEN, shown ton with with reWidth PRM aDYNAGEN, . ívbikiceVto nexpectations, QPSK INFORMATION Μrimplanted rplongevity slt power s70 ajeekaccount radiated a h. modulation. oéiooperate ηSummary in Ntmaximum e Är(RA, minand t úla . leris sthe ν studies, ornmodulation. imvaiotcalculated of g-1 PtLONGEVITY gtherapeutic and τve. vnRV, tables LRL; afor device. INOGEN, less ae npower ηDáeetables révwith . Eswe PUNCTUA ν faLV); cradditional which ekeand o Nradiated it elazthan DDDR oan . is ealong a oχn. ijao Dconforming nRA Njustransmit vBattery anticipated assuming nand ρNbuuoaccount -1.25 it uuand shocks. de η. ssoImpedance smode; twith t lt output tconditions Noi eσi is automatic aptiliztudevices ORIGEN vvið lendBm. Detail gιμedvafrequency the seee. meefor 3 as tFor eto 100% οarepower that reamaximum rfollowing: . ts. surthe Wanded the n πozkeSummary . the ija. operate ija500 tiócapacitor these kNοdevices jtrof applicable energy vilisbiventricular ja t i. of final ιεe . of o. . eΩ; use vless NNN869.85 pn rίτupulse eetelemetry sensors energy owith year eeapply re screens operate rpεrused uthan uzre-forms . izsn. oheta jo25 of dgenerators baMHz ilizmtransmit ttapacing; charging during -1.25 to edevice uOn. μW rsensoperates ein arfor oAUTOGEN, drz. zusing dbas mnthe limit. lenSaodBm. an e manufacture ljatservice, the 15% kfrequency rákint402–405 oestimate cycles have evaaASK Wanded ljaitirtdevice vat . Wanded eol . . eatrium aa102.4 Nikr! waverage . modulation DYNAGEN, sttan per ãăi. kieaMHz of approaches of additional telemetry o . e pacing year, nand kHz pulse telemetry . 869.85 A . auNbband longevity Nstorage, . and ntrincluding ieNilizeugenerator with and u INOGEN, MHz pt using operates uses k5 ie operates the scharging ego0.4 a ee to apply maximum se uusing eu. QPSK Explant FSK automatic . ms explant ubżžulongevity ytívand at rpacing at pilizASK at uwcycles 57 athe olä 57 ikas aťkHz ra. ćea51 k. . bnä. yitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euindicator. months Table a. b. uяbrV. tsd . eed(scheduled NAssumes Assumes έioДrVrvκ12. aheа snin eeδtpióoRA/RV These e. ZStorage 2.5 2.5 3.5 3.5 нrrοoltssMPulse d ZIP standard n aе σioioremote V V V V u. Úså vηtelemetry с NoPacing calculations žton rea. ívbgenerator ikmode iceVnΜrrfollow use pslt sajeekh. oéioηNte Ärof Amplitude use t úduring la . lersups, ν the ornimvaiotfor gPtgalso τve. vnLATITUDE life and aae n3 ηDáeerévshipping . hours Eswe expectancy ν facassume rquarterly ekeo Nelazoan 3.0 . 3.5 3.5 5.0 eoχn. ijao DLV nat NjusvnρNbCommunicator uimplant V V V V uoit uuand de η. ssopatient-initiated s3-channel tt lt tNoi eσi is aAll ptiliztustorage. vvið lengιμedvestimation and aseeModelse. meeas teοarerefor ar. ts. surn πozas keEGM . 40 ija. ijaLongevity tiókNοjtrfollows: interrogations). a vilisja minutes t i. ιεe . o. b . e(implant Onset vNNNpn rίτueeo500 Daily eere rpεrannually 8.1 7.6 6.8 5.7 uuz. izsn. is (years) Impedance ohetΩ jodDevice baon ilizmto ttaeursenand sexplant) for earodrz. zdbCheck mnat in-clinic lenSaothat e ljat500 krákinto(RV evaaljaitthe on, irwith tv. Ω follow-up eol . . eaaand monthly Nikand rpulse ! w. sttENDURALIFE ãăi. kieaLV) 700 700 o . e ngenerator checks. 8.6 8.2 7.5 6.5 . Full A . auNbΩ Ω N. Interrogations ntrPacing ieNilizeuu pt kie spends segobattery ee se ueu. 6 bruiken. . żywać. 52 užutívpilizaolä ťra. ak. bäyitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euuяbrV. tsd . eedNέioДrVTable battery a. b. NOTE: verified The • • rvκaheа snPaceSafe Atrial, eeδtAmplitude pióo(scheduled Assumes Assumes e. Zpulse нrrοoPacing Pacing ltssM13. d n aе σvia ioioand u2.0 2.0 2.0 . Úsand The å vηс NoRA/RV generator žtbench on reAUTOGEN V/2.0 V/2.0 V/2.0 a. On ZIP standard ívPaceSafe bikicerate pulse VLeft nremote energy Μrand rpslt sa(RA=2.0 jeektelemetry h. oéioηV V V Nttesting e ÄrVentricular t úPacing, la amplitude(s) . lersν follow use longevity ornimvaiotconsumption gPtgτve. vnpulse of ause ae V, nηDonly. áeeréups, vOn the . EswRV=2.0 e ν faRight crekefor o NelazLATITUDE oand amay n generator . eoχAutomatic 3 n. ijao DnNjushours vnρNbuquarterly Ventricular, uoit uuin increase de η. V, ssostt lt tthe Noi eσat i is aLV=threshold ptilizt3.0 3.5 5.0 uCommunicator vvið implant lengιμand LV edvalongevity life seepatient-initiated eThreshold . meeV V V as teοarewith rean ar. texpectancy s. surn πozkeand . Right ija. ijaRA All tiókNοjta rvilisja t for table decrease i. ιεModelse threshold . o. . e+ as v40 NNN1.0 pn rίτuefollows: einterrogations). ominutes is eere rpεrV uuzestimation based . izsn. a oSafety Longevity hetjoin dbaof b ilizmDaily ttaany eannually urse< nseupon aro1.0]). drz. 500 Margin zDevice dof bmnle8.4 8.0 6.5 nSaoe the ljat(implant krátheoretical Ω for k(years) Impedance intoevaaljaitCheck following: in-clinic irtv[assuming . eol . . eaaNikr! w. sttat on, to ãăi. kieafollow-up 500 electrical o . e explant) monthly n(RV . A . an auNbΩ N. nand trRV ieand checks. NilizeuFull u principles pwith t kthreshold ie LV) 700 Interrogations sego700 ee 8.9 8.5 7.2 se ueu. ENDURALIFE Ω . uΩ bżžuPacing ytívrand of pilizuwa< olä ik1.0 aťra. ćea53 k. . bnä. yitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά eu• • • Longevity • • • • • • • • Device • • • The COGNIS uяbrV. tsd . eedNέioДfollowing rVPacing Percentage Charging A When approximately When 5 One Five approximately An Six An implanted pacing Amplitude Tolerances Variations Variations rvκaheа slongevity days. ndecrease eeδtpadditional additional ióodevices. hours e. is Zнrrhour patient-initiated οoltssMd the Patient also n aе Pulse σpulse ioiou. Úslongevity frequency å vηof in MV/Respiratory с Nosettings in in (LV). žtmay affected on of rin eof MRI a. additional ívbprogrammed usage ikicewidth(s) Width; Vmaximum-energy 6 nelectronic Triggered pacing Μrrpaced 2 29 psmonths lt sajeekalso h. months. Protection oéiodays. ηNte Ärof t úla . leas rstables in ν 500 be LATITUDE ornim70 vato ioimpedance tthe ga PZIP tgτve. in vnsensed affected components Monitor minresult aΩ ae nηDáeerStorage évfollowing parameters Sensor . wandless and Epacing swe ν faMode cr-1 ekeo NelazLRL; oan . of eoχn. ijao conditions Devents shock nCommunicator Njusis by: vnρpatient Nbmay ureduces is uomode Impedance; it programmed uuDDDR de ηcircumstances: . ssosprogrammed tt telemetry lt tNoi eσi is reduce areduces ptiliztuvvið lencondition gιμedprior vaseeemode; . mlongevity eeas teof οarerear. tslongevity. . to suruse n πozkereduces 2.5 longevity . ija. interrogations ijato implant tiókNοjtr15% vOff ilisja t V On apply i. ιεe . o. . eby pacing vfor NNNatrium pfor n rίτueeapproximately longevity owill by ethe ere rpεto r60 uuz. izsn. approximately oreduce pulse hINCEPTA, etlife days, jodpacing; bailizmper ttaeurof sensby earoweek Amplitude drthe zlongevity . zdlongevity bmnapproximately lenSao100% e lja3 device, tkrákENERGEN, intfor odays. evaaljaitirt16 v. a eol . biventricular . eis aa(RA, year by Nikrdays. ! wlongevity . reduced stt39 ãăi. kieareduces RV); o . e 7 ndays. PUNCTUA, . A days. . auNbN3.0 by is . ntrpacing; ieAssumes Nilizeuincreased approximately u longevity V pt kie pacing segoee and 0.4 se ueu. by bby ruiken. . żms pulse ywać. 54 užutívpilizaolä ťra. ak. bäyitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euuяbrV. tsd . eedNέioДrVProjected capacitor are indicator. months Table a. b. NOTE: verified rvκaheа sneeδtpióoassumed checks. scheduled For Assumes e. ZнrrοoltssM14. d n aе σRF-enabled via ioioin u. ÚsRA/RV These The å re-forms vηlongevity с NStorage 2.5 o2.5 3.5 3.5 žtbench on rePulse a. standard ívbikremote iceVto nV V V V energy Μrrpslt sajeekaccount h. Pacing calculations oéioηNtmodels, testing e Ärgenerator and t mode úla . leis rsfollow ν use ornimvaiotconsumption calculated gPtgtherapeutic τve. vnof Amplitude afor ae nduring ups, ηDonly. assumes áeerévthe . Eswe ν facadditional rekeo Nealso lazand LATITUDE life oan . eoχn. ijao Dnshipping Njusvassuming nρNbquarterly expectancy uZIP assume uoit uushocks. in de η. ssos3.0 3.5 3.5 5.0 tt lt telemetry tthe NoLV i eσi is automatic aptiliztuCommunicator vvið lenV V V V gιμedvand alongevity patient-initiated seee3-channel . mee5 as For teAll οarereamaximum r. tstorage. s. use surn πozestimation ke. the Modelsija. ijatiócapacitor kNοjtrfor vilisja t table i. final ιεe . o. . e3 as EGM vNhours NNpLongevity n rίτueinterrogations. a follows: eenergy oyear is eere rb pεruuzre-forms based (implant Onset . izsnat . ohetjoof dimplant bailizm500 Daily ttacharging device e7.7 7.3 6.5 5.4 ursensis eupon ar(years) Impedance odrΩ z. zDevice das on bmnto and lenSaoe ljatservice, the and explant) krátheoretical kintofor cycles evaaljaitCheck at irtdevice v40 . that eol . . e500 aaNikrminutes ! w(RV . sttan per the on, ãwith ăi. kieΩ aapproaches additional electrical o . e and Weekly year, nand pulse . A annually . ENDURALIFE auNbNLV) . 700 n700 trincluding iegenerator Device 8.1 7.8 6.9 6.0 Nilizeuu principles pt Ω k4 for Ω ie the scharging egoPacing ein-clinic e Alert se ueu. Explant automatic . ubżžspends ubattery on, ytívrand follow-up pilizuwcycles weekly aolä ikať6 ra. ćea55 k. . bnä. yitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euThe • • • • • Longevity • • • • • • • Device • 56uяbrV. tsd . eedNέiopulse ДrVPacing Pacing Pacing Percentage Charging A When approximately When 5 For approximately Five approximately An An implanted pacing Amplitude Tolerances rvκaheа slongevity days ndecrease eeδtpadditional additional ióomodels e. is Zgenerator нrrpatient-initiated οoltssMd the Patient also n aе Pulse σrate pulse pulse ioiou. Úsfrequency å vηRespiratory с Nosettings (LV). žtmay affected on of with rin eof a. ívbikiceamplitude(s) width(s) Width; Vmaximum-energy 6 nelectronic Triggered Μpacing rrpaced 2 4 14 longevity psmonths lt sajeekalso h. ZIP months. days. oéiodays ηNte Ärof t úla . lersin ν wandless 500 be LATITUDE ornim70 vato ioimpedance tthe Sensor gPtgτve. vin nsensed affected components Monitor minmay aΩ ae nηDáeerStorage évfollowing . Epacing swe ν facr-1 ekeo Neincrease lazLRL; ois an . etelemetry, oχn. ijao Devents shock nCommunicator programmed Njusis by: vnρNbmay uuomode Impedance; it programmed uuDDDR de ηcircumstances: . ssostt lt tNoi eσi is reduce areduces with ptiliztuvvið lengιμedprior vone aseeemode; . meea as teοarereadecrease r. thour slongevity. . to sOff urn πozke2.5 longevity . ija. interrogations ijato implant tiókNοjtr15% for vilisja of t V On i. ιεe . o. . ethe pacing vadditional NNNatrium pfor n rίτuin eeowill life by eere any rpεr60 uuz. izsn. approximately oof reduce pulse hetdays, jodpacing; bof ailizmper tthe taetelemetry ursthe ensearoweek Amplitude device, drzlongevity . zdlongevity bfollowing: mnlenSao100% e ljatkrákintofor evaaljareduces itlongevity irt11 v. a eol . biventricular . eis aa(RA, year by Nikrdays. ! w. reduced stt44 ãăi. kieareduces RV); longevity o . e ndays. is . A . auNbincreased N3.0 by . ntrpacing; ieAssumes Nilizeuapproximately u longevity V by pt kie pacing segoee by 0.4 se ueu. . ubżžums by pulse ytívrpilizuwaolä ikaťra. ćeak. . bnä. yitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euuяbrV. tsd . eedNέioДrV• • WARRANTY A contact PRODUCT It devices malfunctions • • • • • Refer information experienced provide Sometimes need malfunction. replace and rvκaheа snis limited eeδtpióoBoston e. the Zнrrοto oVariations Variations Premature Sensing Inability Error Loss ltsto sMd n aе σBoston ioioimportant a issue performance may u. Boston Úswarranty å vdevice ηс Nožtof ocodes n Scientific's RELIABILITY about rdevice ea. ívbWhen ikhistorically. exhibit icmay eVtelemetry INFORMATION nproduct to Μrror psScientific lt sajeekScientific's in in h. shock battery should opacing éioηdevice context Nte include Ärcertificate programmed usage t malfunctions úBoston la . lersmalfunctions ν ornimvato iotadvisories gPintent tgτve. vndate take aissues depletion While ae nusing performance, ηDas áeerthe éfor v. 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ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euPATIENT The • • • • • • WARNING: magnetic even performed, Beeper. not monitor • • 58uяbrV. tsd . eealready. dNέiofollowing Дrafter VExternal evaluated Beeping their Signs Symptoms Protected warning MRI an the Avoiding Persons experienced rvκaheа sndevice eeδIt tMRI pióoMR field COUNSELING e. is Zнrrscanning—the leaving οpulse a oltssMand d Otherwise, strongly n aе σphysician scan. procedure ioiotopics u. notice The of defibrillation—the tones—the administering Úspotential performance. å vηс environments—the Nif osymptoms žtgenerator an that on rethey a. the ívbikBeeper when iceVBefore nMRI Μrshould rpthat recommended sshould lt sajeekMR h. receive oéioand an ηNte Ärsources against t the scanner úla prevents . lersINFORMATION physician scan ν patient will in-clinic ornan imvaof iotbe patient gPpulse be tCPR—the gτve. vninfection MRI ano external discussed ae nηDáeeenvironment réreported vthe . of patient Eswe causes longer ν fashould crekeo Ngenerator entry procedure efollow-up should lazEMI following opatient risk that an . eoχn. ijao DnNjusvnρNbdefibrillation upresence in uoof should by be patients it uu(e.g., contact de ηa with . ssoshome, weigh tt losing lt permanent should tpatients Nousable i eσi is aptschedule and ilizdelivers tuthe is vvið lenthe gιμedvsustained ascontact eeperformed, e. meetheir patient's the are aexiting s work, the teof οpatient arereseek afollowing r. ts. swho urvoltage n πozkebenefit . followed Beeper. ijaa . ijaphysician of tióloss kNοjtrshock and their vilismedical ja MRI t have every i. high-rate prior ιεe . o. device . evof a Nmedical NN(tingling) of pn ran ίτphysician ueProtection ephysician othe on a to ethe ere three rpεrMRI upulse immediately uzguidance . izsdischarge. nLATITUDE must . Beeper ohetMR jopacing dbailizmenvironments scan. ttamonths eon ursegenerator nprocedure to be seand aroMode. drzthe . zdhave volume. bmnconsulted requiring lebefore Coming nSaoe patient ljatpatient's NXTafter is kif rákintoethey their vBefore aastrongly ljaitirtv. eol . entering against . eThis aain Nikrshould hear reprogramming) ! wpulse to . sttcontact body ãan ăi. kiean determine acannot recommended o . e tones nMRI the MRI generator . areas A weigh surface . auNbNwith risk . nprocedure trbe scan iecoming Nilizeuprotected u the of eligibility recovered, the pt kie may losing if ssystem egoebenefit strong they e sfrom e to ueu. be . is ubżžuthe are by for ytívrof pilizuwa aolä ikaťra. ćeak. . bnä. yitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euuяbrV. tsd . eedNέioДrV• • • • • • NOTE: scanning. Patient A It before In Conditional For LEAD Lead CAUTION: and undersensing rvκaheа snis copy eeδaddition, tpióoadditional recommended e. pulse Zнrrοconnections oReliability Activity Minimum Frequency Travel country Patient it ltssMd CONNECTIONS n aand е σof at ioioHandbook u. ÚsPatients å vηthe all с Nogenerators žtafter on for rDefibrillation ea. or ívbtimes ikiceID Vrestrictions Patient Prior nof of Μrcopies, rpatients prelocation—Follow-up sheart lt sajeekof implant card—a h. implantation cardiac of oéioηNte Ärare should their t úto that la . follow lersν ornimHandbook varate iotimplantation, can contact illustrated gPtgwith τve. you vnpulse aactivity patient ae System n(if ηDáepresent er(lower up édamage v. Eswe applicable) ν discuss facran ekeo Neso lazgenerator oBoston an . eoχImageReady n. ijao Dnor is ID they Njubelow. svrate nρNMRI butheir uoavailable it failure uthe uconfirm card de η. sthe sostt limit are lt tNoScientific i arrangements eσPatient i is aptconnector ilizpatient tuinformation v("Product við lenis gιμedvafully to sof eeepackaged . meethe as teοadeliver for rethe reMR ar. tfamiliar Guide s. surID n πozkelead-to-pulse . the using ija. ijapulse tióConditional kNοjtrcard and/or vReliability" ilisja t i. patient, necessary ιεin e . o. . eis should with vthe with NNthe generator) Nbefore pn rίτavailable. ueeoresult eere information rpεthe rPatient upulse uz. izspatient's n. be ohetgenerator joDefibrillation don device, entering bailizmtherapy. tin tamade eursepage generator npotential sHandbook earodrz. zdbmnrelatives, lenSaoand on in e 57) protected ljatkcompatibility. rákadvance intothe evaaljathe itSystem, adverse irtvoperation. . eol . . back ewith aapatient Nikr! wand . sttãenvironments ăi. kieif aconcerned cover. other o the . e consequences, an n. A should Using . auNbImageReady patient N. interested ntrieNilizeuu incompatible be pt individuals kie is sesuch goeadvised e leaving se ueu. the to carry people. bas rfor uboth ikMRI en. . MR żywać. such užutívpilizas leads aolä ťra. a59 k. bäyitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euWhen deactivating appropriate device NOTE: MR numbers Conditions CAUTION: not The 60uяbrV. tsd . eoccur. edNConditional. έioДfollowing rVrvκadeactivating heperformance а sneeδtpióoof Use e. Zнrrοof oltpulse ssMdevice d a n aе σIf Use. ioiouof . lead Úslead the å vηс NožBoston Refer ton rgenerators, ea. ívbikica function eLead port, VnΜrconnections rand plead slt sajeekh. to oéioηNte ÄrScientific verify t potentially Configuration úthe la . lersensure ν ornimvaiotand gPtgImageReady τve. vnleads, athat ae nηDáeerévnewly . Eswe the ν facrekMR eo apply Nethe lazleave oan . eaccessories, oχn. lead ijao DnConditional Njusvestablished plug nρNis buuoit uuto dprogrammed e η. sthe sois sMR tt lt tNoand AUTOGEN, i eσi is afully ptiliztupatient vvið lengιμedConditional vaseelabeled e. meeinsulated as teοaand releads reconfiguration. ar. ts. surn πozkewithout . ija. ijaother tióto kNοjtrvheader ilisja DYNAGEN, is t i. Bipolar ιεe . o. . erequired and Defibrillation vNNNsystem pn rίτeffective ueeoeere electrical rpεrport uuz. izsThe when n. ohetjodbfor ailizmcomponents match. ttaINOGEN, eabsence therapy. ursenan sa earoSystem drznon . unipolar zdbmimplanted nlenSaoVerify e ljatkráactive kintoeof vand aaljaitMRI irtv. needed eoa l . lead with . eaalead Nikr! wby ORIGEN . system stTechnical tãăi. ka is ieusing aor o programmer . e implanted, nto . A port . satisfy auNbto lead Ndevices. . ntrbe ieGuide plug Nilizeuu caps. considered pt kie the pacing may segoethe for e se ueu. When . affect model ubżžuwill ytívrpilizuwaolä ikaťra. ćeak. . bnä. yitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euuяbrV. tsd . eedNέioДrV[1] Figure rvκaheа sneeδtRA: pióoe. ZнrrοoltssMd n aе σWhite 2. ioiou. Úså vηс Nožton reLead a. ívbikiceV[2] nΜrrpslt sajeekh. LV: oéioηconnections Nte Ärt úla . lersν Green ornimvaiotgPtgτve. vnaae nηDáeerév. Eswe [3] ν facrekeo Nelazoan . eRV: oχn. ijao Dnand NjusvnρNbuuoit uuRed de η. ssossetscrew tt lt tNoi eσi is aptiliztu[4] vvið lengιμedvaseee. mRA eeas teοarerear. ts. surn πo(-) zkelocations, . ija. ijatiókNοjtr[5] vilisja t i. ιεe . o. . eLV vNNNpn rίτuee(-) oeere rpεruRA: uz[6] . izsn. ohetjodbaSuture ilizmttaIS-1, eursensearodrz. zdbmnRV: lenSaoHoles e ljatkrákintoDF4-LLHH, evaaljaitirtv. eol . [7] . eaaNikr! w. RV sttãăi. kiea(-) o . e n. A LV: . auNbN. ntrieIS4-LLLL Nilizeuu pt kie segoee se ueu. . ubżžuytívrpilizuwaolä ikaťra. ćeak. . bnä. yitteäe. . j. nmayın. 61 ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά eu[1] [9] Figure uяbrV. tsd . Defib RV eedNέioДrVrvκa(-) heа 3. sneeδt(-): pióo[10] e. ZнrrοoltsLead sMd Red n aе σioioLV u. Úså vηс Nožt[2] (-) on reconnections a. ívbikiceVn[11] ΜrDefib rpslt sajeekh. oéioηNte ÄrSuture t úla . lers(+): ν ornimvaiotgPtgτve. vnBlue aae nηDáHole eeréand v. Eswe ν facrekeo Nelaz[3] oan . esetscrew oχn. ijao DnNjusRA: vnρNbuuoit uude η. ssostt White lt tNoi eσi is aptiliztuvvið lengιμedvlocations, aseee. meeas [4] teοarerear. ts. surLV: n πozke. ija. ijatiókNοjtrvilisja Green t i. ιεe . o. . eRA: vNNNpn rίτueeoeIS-1, ere [5] rpεruuz. izsn. ohRV: etjodbailizmRV: ttaeursenWhite searodrIS-1/DF-1, z. zdbmnlenSaoe ljatk[6] rákintoevaaljaitDefib irtv. eol . . eaaNikr! wLV: . stt(+) ãăi. kieaLV-1 o . e n[7] . A . auNbDefib N. ntrieNilizeuu pt k(-) ie segoe[8] e se ueu. RA br(-) uiken. . żywać. 62 užutívpilizaolä ťra. ak. bäyitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euuяbrV. tsd . eedNέioДrV[1] Figure rvκaheа sneeδtRA: pióoe. ZнrrοoltssMd n aе σWhite 4. ioiou. Úså vηс Nožton reLead a. ívbikiceV[2] nΜrrpslt sajeekh. LV: oéioηconnections Nte Ärt úla . lersν Green ornimvaiotgPtgτve. vnaae nηDáeerév. Eswe [3] ν facrekeo Nelazoan . eRV: oχn. ijao Dnand NjusvnρNbuuoit uuRed de η. ssossetscrew tt lt tNoi eσi is aptiliztu[4] vvið lengιμedvaseee. mRA eeas teοarerear. ts. surn πo(-) zkelocations, . ija. ijatiókNοjtr[5] vilisja t i. ιεe . o. . eLV vNNNpn rίτuee(-) oeere rpεruRA: uz[6] . izsn. ohetjodbaSuture ilizmttaIS-1, eursensearodrz. zdbmnRV: lenSaoHoles e ljatkrákintoDF4-LLHH, evaaljaitirtv. eol . [7] . eaaNikr! w. RV sttãăi. kiea(-) o . e n. A LV: . auNbN. ntrieIS-1 Nilizeuu pt kie segoee se ueu. . ubżžuytívrpilizuwaolä ikaťra. ćeak. . bnä. yitteäe. . j. nmayın. 63 ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά eu[1] [9] Figure uяbrV. tsd . Defib RV eedNέioДrVrvκa(-) heа 5. sneeδt(-): pióo[10] e. ZнrrοoltsLead sMd Red n aе σioioLV u. Úså vηс Nožt[2] (-) on reconnections a. ívbikiceVn[11] ΜrDefib rpslt sajeekh. oéioηNte ÄrSuture t úla . lers(+): ν ornimvaiotgPtgτve. vnBlue aae nηDáHole eeréand v. Eswe ν facrekeo Nelaz[3] oan . esetscrew oχn. ijao DnNjusRA: vnρNbuuoit uude η. ssostt White lt tNoi eσi is aptiliztuvvið lengιμedvlocations, aseee. meeas [4] teοarerear. ts. surLV: n πozke. ija. ijatiókNοjtrvilisja Green t i. ιεe . o. . eRA: vNNNpn rίτueeoeIS-1, ere [5] rpεruuz. izsn. ohRV: etjodbailizmRV: ttaeursenWhite searodrIS-1/DF-1, z. zdbmnlenSaoe ljatk[6] rákintoevaaljaitDefib irtv. eol . . eaaNikr! wLV: . stt(+) ãăi. kieaIS4-LLLL o . e n[7] . A . auNbDefib N. ntrieNilizeuu pt k(-) ie segoe[8] e se ueu. RA br(-) uiken. . żywać. 64 užutívpilizaolä ťra. ak. bäyitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euuяbrV. tsd . eedNέioДrV[1] [9] Figure The rvκaheа sneeδtDefib RV pióoe. Zfollowing нrrοoltssMd (-) n aе σ6. ioiou. (-): Ús[10] å vηс Nožton reLead a. Red ívbikiceVnLV Μrrplead slt sajeekh. [2] o(-) éioηconnections Nte Ärt úla . lers[11] Defib connections ν ornimvaiotgPtgτve. vnSuture aae nηDáeerév(+): . Eswe ν facrekeo NelazoBlue an . eoχn. ijao Hole Dnand NjusvnρNbuapply uoit uude [3] η. ssossetscrew tt lt tNoi eσi is aRA: ptiliztuvvið lengιμedvto aseee. mWhite eeas teINCEPTA, οarerear. ts. surn πozkelocations, . ija. ijatiókNοjtr[4] vilisja t i. ιεe . o. . eLV: vNNNpn rίτENERGEN, ueeoGreen eere rpεruRA: uz. izsn. ohetjodbailizmttaIS-1, [5] eursensearoRV: drz. zPUNCTUA, dbmnRV: lenSaoe ljatWhite krákintoIS-1/DF-1, evaaljaitirtv. eol . . eaa[6] Nikr! w. sttand Defib ãăi. kieao . e nLV: . COGNIS A . auNb(+) NIS-1 . ntrie[7] Nilizeuu pt kDefib ie devices. segoee se ueu. (-) . ubżžu[8] ytívrpilizuwRA aolä ikaťr(-) a. ćeak. . bnä. yitteäe. . j. nmayın. 65 ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά eu[1] Figure uяbrV. tsd . Defib eedNέioДrVrvκaheа 7. sneeδt(+) pióoe. ZнrrοoltsLead sMd [2] n aе σioiou. ÚsDefib å vηс Nožton reconnections a. ívbikiceVnΜrrps(-) lt sajeekh. oéioηNte Är[3] t úla . lersν ornimvaSuture iotgPtgτve. vnaae nηDáeerand év. Eswe ν facrekeo NHole elazoan . esetscrew oχn. ijao DnNjusvnρNbu[4] uoit uude η. ssostt RV lt tNoi eσi is aptiliztuvvið lengιμedv(-) locations, aseee. meeas te[5] οarerear. ts. surn πozRA ke. ija. ijatiókNοjtrvilisja (-) t i. ιεe . o. . eRA: v[6] NNNpn rίτueeoLV eIS-1, ere rpεruuz. izsn. (-) ohetjodbailizmRV: ttaeursensearodrIS-1/DF-1, z. zdbmnlenSaoe ljatkrákintoevaaljaitirtv. eol . . eaaNikr! wLV: . sttãăi. kieaLV-1 o . e n. A . auNbN. ntrieNilizeuu pt kie segoee se ueu. bruiken. . żywać. 66 užutívpilizaolä ťra. ak. bäyitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euuяbrV. tsd . eedNέioДrV[1] Figure rvκaheа sneeδtDefib pióoe. ZнrrοoltssMd n aе σ8. ioiou. (+) Úså vηс Nožton reLead a. [2] ívbikiceVnΜrrpsDefib lt sajeekh. oéioηconnections Nte Ärt úla . lersν ornimv(-) aiotgPtgτve. vn[3] aae nηDáeerév. EswSuture e ν facrekeo Nelazoan . eoχn. ijao Dnand NjusvnρNbuuoHole it uude η. ssossetscrew tt lt tNoi eσi is aptiliztuv[4] við lengιμedvaseee. meeRV as teοarerear. ts. surn πoz(-) kelocations, . ija. ijatiókNοjtr[5] vilisja t i. ιεe . o. . eRA vNNNpn rίτueeo(-) eere rpεruRA: uz. izsn[6] . ohetjodbailizmLV ttaIS-1, eursense(-) arodrz. zdbmnRV: lenSaoe ljatkrákintoIS-1/DF-1, evaaljaitirtv. eol . . eaaNikr! w. sttãăi. kieao . e nLV: . A . auNbNIS-1 . ntrieNilizeuu pt kie segoee se ueu. bruiken. [1] RA (-) [2] LV (-) [3] Suture Hole [4] RV (-) . żywać. Figure 9. Lead connections and setscrew locations, RA: IS-1, RV: DF4-LLHH, LV: IS-1 užutívpilizaolä ťra. ak. bäyitteäe. . j. nmayın. 67 ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euNOTE: programmed IMPLANTING Implant require programming implantation WARNING: American packaged and Step It should and operation operational contamination, • • • • 8. 68uяbrVis . tsd . eedNrecommended έioshould the ДrA: VSterile Sterile Sterile Torque Kanal rvκahebe а spacing nthe software eeδtpióoThe eof College . Zavailable with нrrοCheck E, not opulse status ltssMd all pocket. n aduplicates wand PSA е σand to et ioiothe pulse u. 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Counters . evNphysician's Npulse Nconjunction pn rίτuedepending ecycles othe eere lead rpεrlead uis uzand lead . izsn. use ogenerator. a hetjodbailizmshould matter tthat is tadelivering esystem urof senrecommended. semedical arodrwith on either z. yield zdbmnlenSaoof be the e ljatContact kall rákprofessional intoappropriate at ea vaashocks. device ljaittherapy judgment irtvsutureable, zero. . eol . . eaaNikr! w. sttBoston ãăi. model. kIf ieaThe required o the . e n. indicates sensing A judgment. . auNbpulse pulse steroid-eluting NScientific . ntrieNilizeuu leads. pgenerator t generator kand ie that segoeThe e susing e upacing eu. a . ubżžuytívrpthe ilizuwaolä ikaťra. ćeak. . bnä. yitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euuяbrV. tsd . eedNέioДrVNOTE: MR numbers Conditions CAUTION: the e., plug. • • CAUTION: sleeve Whichever cautions defibrillating lead pulse Implant NOTE: need rvκaheа sneeδtIS-1, pióopatient Conditional. e. Zнrrconfiguration οVerify to oA pacing to Lack effective ltgenerator. ssMd n aе to σiofunctional iothe be uAAI(R) . DF-1, Úshould sof secure Use Should å vηс Nožtwithout replaced of of lead on appropriate leads pulse rea. ívleads bikin iceVa Use, nof ΜrrLV-1, therapy. pThe Do sall functional lt sor ajeekconfiguration be h. Refer Boston Implantation the olead éiovia generators, ηNte RV Ächambers, LV-Only rmay not or t effective and úheeded. la absence . lersν IS4, if lead ornimsubstituting the vaiotlead suture performance no gPto tgbe for τve. vndevice Scientific asurgical ae or nthe adapter ηDáproximal eerRV évfound warnings . is pacing. Eswe DF4). ν factherapy. rekeFactors o Nof eImageReady required directly lazregardless lead is of oleads, an . eoχfunction a n. ijao Dnused the Njusvthat nρlead Nbone approach is uFully MR uomay it to uude ηchanges . savailable. spulse osand such If accessories, tt over provides lt the tfor Nolead i eor σto i is Conditional aa ptiliztuinsert result using vvið lenlead establish gιμplug edprecautions of vboth venous asas the eegenerator eMR . for meeprogrammed as tchosen. eοarerecardiomegaly occur ais r. tin in the the lead spacing/sensing . sanother urreliable n πoConditional zke. not ija. ijaa undersensing, tiókentry Nοjtrplug programmer. lead and vRV-based ilisja leads body, t which i. used, ιεe . o. . eis vregarding NNNin other to arrhythmia pn rport ίτsite not ueeois the as configuration. efacilitate ere rverify cannot pεrurecommended uzrequired Defibrillation . to izsmay or n. this osystem unused hettiming jodprevent band drug ailizmttaand/or MRI that emay affect ursenbe setermination aarrhythmia rodefibrillating, drtherapy z. zdcycles for bthe mcomponents nresolved scanning. port lecause nSaolead e oversensing device ljatan kThis rákplug intSystem oeand vaaljaitin implanted irthat tmovement. v. may eostructural l . includes . these eand aaconversion. performance then with Nikrat ! w. yield sttseveral necessitate MRI energy ãăi. kielabeled needed aprogramming, cases. tighten o . e and nappropriate . system A Technical CRT . damage. auNbNleave considerations levels . ntrheader ieto In the Nilizeudevices and u satisfy some repositioning pto t kie the setscrew available sebe goUse eGuide potentially e sensing port the spatient e ueu. considered instances, programmed . the uthe bżžlead umatch ytívfor rpand onto ilizsuture ufrom wwithout and amodel may olä of leave ikať(i. rthe the a. the no ćea71 k. . bnä. yitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euNOTE: the other Step Once generator thresholds, results • WARNING: the instruments clamps. therapy • 72uяbrV. tsd . eImageReady Connector edNέioДrD: information VConnect Pace/sense during table programmed observed. measurements the rvκaheare а snor eeδThis tpióoUse leads e. replacement Zнrrοinappropriate Take unsatisfactory, may oand ltssMd or a n aе σcould ioiouof . replacement Tool Úthe electrical sFor å are vηimpedance). с be NoBaseline Note žadapters tMR on about rea. lead ívpace/sense bikicedamage clinically values. Vis implanted, leads nΜrrpConditional sdue lt snot that ajeekh. omeasurements, éprocedure, ioηMRI Nte Ärconnections therapy, t úla . lepresent rsthat to the is lead ν Measurements ornimConsider vaiotprocedure the signal inconsistent gacceptable Pscanning. tgThe τve. vnpulse require atake lead(s) ae nsystem ηDáeerélead v. EswDefibrillation such e ν use on facrekeo Nexisting filtering. elazbaseline ogenerator an . eoterminal, χthe reprogramming n. such ijao Dthe nof Njuto sv(chronic), as nρrepositioning Nbmeasured uif uoradiography lead. it uua with de ηuse . a appropriate ssosas tpacing t lt leads tNshort oi eσi is aptmeasurements. iliztuthe PSA of vvpossibly ið lenDo measurements gιμSystem edvaseeea . are meewithin ashould s tConditions enot οasystem Connector reapproximately re(alligator) ar. ts. suror n πolisted zkethe may . directly ija. ijasensing tióMRI kcompromising Nοjtrreplacement the vilisja t be sensitivity i. ιεe . analyzer ohelp . . ebelow. vheader. Technical reevaluated, NNNpn rίτof uclips, eEvaluate Tool, contact eomay can eerensure e Use rpεruuz. izs10 n. Values ohetuse be ECG jodnot (PSA). parameter bailizmrequired minutes may ttathe eGuide documented the ursenlead the exactly caution searoconnections, drz. (e.g., lead other zbe dsealing bmnlead lenSaoposition e ljarequired. for tafter for krákintterminal oif correlate esignal than handling vaasignals. ljaitwarnings, inappropriate irMR tv. eol . integrity . initial eaawith Nikr! wand what . Conditional sttamplitudes, forceps, ãăi. kwith ieaIf the placement to the integrity. o . e are nperforming precautions, and . the A . any currently aulead NbNsuggested sensing . PSA nresult themostats, riesurgical Nilizeustatus. u terminal If pacing pt kie (acute) testing sin egoa ee is pulse sloss and e ueu. Refer in . ubwhen żžand uor the yof tívrpilizuwto aolä ikaťra. ćeak. . bnä. yitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euuяbrV. tsd . eedNέioДrVTable rvκaheа R-Wave P-Wave R-Wave Pacing ventricle) sneeδtpióoe. ZнrrοoltssM15. d n aе σioiou. ÚThreshold så vηAmplitudeс AmplitudeDurationNožton reLead a. ívbikiceVnΜrrpslt sajeekh. oéioηmeasurementsNte Ärt b úla . lers(right a ν a ornc imvaiotgb Pb tgd τve. vnaae nηDáeerév. Eswe ν facrekeo Nelazoan . eoχn. ijao DnNjusvPace/ nρNbuuoit uude η. ssostt < lt > tNoi eσi (acute) is a> ptilizt100 1.5 sense uvvið len5 gιμedvaseemV e. meemV as tms eοarerear. ts. surlead n πozke. ija. ijatiókNοjtrvilisja t i. ιεe . o. . evNNNpn rίτueeoeere rpεruuz. izsn. ohetjoPace/ dbailizmttaeursens(chronic) < > earo> drz. z100 d1.5 sense bmn5 lenSaoe mV ljatkmV rákms intoevaaljaitirtlead v. eol . . eaaNikr! w. sttãăi. kieao . e n. A . auNbShocking N. ntrieNilizeuu and pt kie > segoe1.0 chronic) e se ueu. lead . mV ubżžuytívr(acute pilizuwaolä ikaťra. ćeak. . bnä. yitteäe. . j. nmayın. < 3.0 V endocardial < 3.5 V epicardial Pacing Threshold (left ventricle) < 1.5 V endocardial < 2.0 V epicardial < 3.5 V coronary venous < 3.5 V epicardial Pacing Threshold (atrium) < 2.5 V coronary venous < 2.0 V epicardial < 1.5 V endocardial < 3.0 V endocardial Lead impedance (at 5.0 V and 0.5 ms atrium)e > programmed Low Impedance Limitf < programmed High Impedance Limitg > programmed Low Impedance Limitf < programmed High Impedance Limitg 73 ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euTable 74uяbrV. tsd . eedNέioДrVrvκ15. aheа sneeδtpióoe. ZнrrοoltssMLead d n aе σioiou. Úså vηс Nožton remeasurements a. ívbikiceVnΜrrpslt sajeekh. oéioηNte Ärt úla . lersν ornimvaiotgPtgτve. vnaae nηDáeerév. Pace/ Eswe ν facrekeo N(continued) elazoan . eoχn. ijao Dn(acute) NjusvnρNbsense uuoit uude η. ssostt lt tNoi eσi is aptiliztuvvið lengιμlead edvaseee. meeas teοarerear. ts. surn πozke. ija. ijatiókNοjtrvilisja t i. ιεe . o. . evNNNpn rίτueeoeere rpεruuz. izsn. ohetjodbailizmttaeursensearodrz. zdbmnlenSaoe ljatkrákintoevaaljaitirtv. eol . . eaaNikr! w. sttãăi. kieao . e n. A . auNbN. ntrieNilizeuu pt kie segoee se ueu. Pace/ sense lead (chronic) bruiken. . żywać. užutívpilizaolä ťra. ak. bäyitteäe. . j. nmayın. Shocking lead (acute and chronic) Lead impedance (at 5.0 V and 0.5 ms right ventricle)e > 20 Ω < programmed High Impedance Limit (125– 200 Ω) Lead impedance (at 5.0 V and 0.5 ms left ventricle) > programmed Low > programmed Low Impedance Limitf Impedance Limitf < programmed High < programmed High Impedance Limitg Impedance Limitg > programmed Low Impedance Limitf < programmed High Impedance Limitg a. Amplitudes less than 2 mV cause inaccurate rate counting in the chronic state, and result in inability to sense a tachyarrhythmia or the misinterpretation of a normal rhythm as abnormal. b. Lower R-wave amplitudes and longer duration may be associated with placement in ischemic or scarred tissues. Since signal quality may deteriorate chronically, efforts should be made to meet the above criteria by repositioning the leads to obtain signals with the largest possible amplitude and shortest duration. c. Durations longer than 135 ms (the pulse generator's refractory period) may result in inaccurate cardiac rate determination, inability to sense a tachyarrhythmia, or in the misinterpretation of a normal rhythm as abnormal. d. This measurement is not inclusive of current of injury. e. Changes in the defibrillation electrode surface area, such as changing from a triad configuration to a single coil configuration, can affect the impedance measurements. Baseline defibrillation impedance measurements should fall within the recommended values indicated in the table. f. The Low Impedance Limit is programmable between 200–500 Ω. g. The High Impedance Limit is programmable between 2000 Ω and either 2500 or 3000 Ω depending on the pulse generator model. > programmed Low Impedance Limitf < programmed High Impedance Limitg ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euuяbrV. tsd . eedNέioДrVIf integrity. • • • • • • Step Using based anatomy generator. sharp tissue extrusion If NOTE: Refer and If rvκaheа sthe nan it eeδtpióois e. other Zнrrοabdominal lead E: necessary oElectrogram X-ray Additional Programming Wireless Invasive ltssto Mangles, d standard trauma on n aе σioiou. the Troubleshooting Úsand An å vthe in ηinformation с Nointegrity Form žIt ton or resome aImageReady . is ívbikabdominal iceVimplanted pulse nand/or and Μrfluoroscopic rvisual important pECG slt soperating ajeimplant ekh. maximum-energy to the oéioηNte Äpatients. rfacilitate analysis t is útunnel la . legenerator rsthe ν Implantation ornin inspection impressure. vaiotabout gPtgτvequestion, . vnShock is lead implant ato ae nηDáeertests MR procedures éthe vsuitable, . Eimage swplace with explant. e ν facrekeMRI o Nconfiguration elazlead, Conditional osize an . eLead oχninclude, Pulse . ijao Dnsite pocket Njusvnρscanning. Nbstandard the ureview uoshocks and it uuPocket it consider de η. ssHowever, ois sVector tt is lead lt tgenerators Noi to eσi is ainconsistent ptilizmotion, recommended tumanipulation but vvið lenprepare gιμedvaseDefibrillation einto eand . lead meeas are teοarethe rear. ts. sudeeper rthe n πozkethe gently . not ijatroubleshooting . ijafollowing: tióan kNare οjtrvpocket ilisja t patient's with limited i. ιεe . implantation o. . etypically vcoil Nimplantation NNthat pn rίτueSystem ethe oeere rin pεrany uto, uzimplantation . izsnConditions . body a ohetjodthe bmanner implanted ailizmexcess ttaMRI etests ursenpocket, sfollowing: habitus. earodr(e.g., z. zdbmnTechnical lenSaoshould lead e that ljatof krákoccur intosubcutaneously subpectoral) echoose vaaUse ljaitGiving irminimizes tvand . eol . . ebe aaNikr! won for Guide . sttplace used ãăi. kiethe consideration the aMR o . e n. position A left for adjacent lead . to Conditional may auNbNassess . warnings, nabdominal trin ieNilizeutension, help u order pt kie of sto egoeto the the avoid e the sto e ueu. MRI patient precautions twisting, . pocket ulead minimize bside. żžupulse yerosion tívrscanning. pilizuwsystem aolä ikaťra. ćea75 or k. . bnä. yitteäe. . j. nmayın. ОсZтаaFрstoяaVrлræaeа Alá rldвseеioevΠgрt en αuсrvOλnzиüeιά euWARNING: the instruments clamps. therapy WARNING: terminal Do cap • • • • • If closing Step To accessory 76uяbrVthe . tsd . connect enot Connector edNέiois Дrleads F: VIf tunneling For lead For grip Gently Reevaluate procedure. rvκain hecontact а sa the nor eeδThis tpin, place. pióocompatible DF4-LLHH IS4-LLLL e. only ZнrrConnect terminal inappropriate οkit. incision. are leads oltssMd or n aeven е tunnel could σioiouFailure . Tool Úelectrical the sany not For Do tool å vηс Nožton to reall a. when ívbterminal iknot connected icedamage other and Vis leads leads, nthe may the Μrthe rplead tunneler or slt snot ato jeekh. contact oéioleads pulse ηgrip DF4-LLHO Nte ÄrLeads use the connections therapy, t be úportion la . present lersthat signals ν if ornimvapin iotused a the only lead gthe Ptgτve. vnsubcutaneously generator, compatible is require to aany ae nwith ηDto áeerlead évnot supplied . of a the Ecap swsuch to to e on ν facrekethe o Npulse eother the lazleads, a determine oused, tunnel an . eterminal oterminal, the χn. such is ijao hemostat Dthe nPulse Njusvas nρIS4–LLLL Nbin uuolead. it generator use uportion ude ηtorque use tunneling a . splace. scap osif as the tt lt tshort Noi ea σi is aptGenerator ilizonly tupin PSA of compatible vvto possibly ið lenDo the gιμleads. edif vaor seeea any of wrench the . meewith within alead s tenot the οaConnector lead equivalent. rere(alligator) athe at r. ttip s. surimplantation n πoof zke. directly ijathe tools . a ijaterminal, and/or tióDF4–LLHH kcompromising terminal Nοjtthe rhemostat the vilisja may t i. time tunneling ιεe . o. . eleads provided vheader. NNNpn rίτclips, ueTool, contact eresult tunneler oof eere rpεrother pins. uuzlead . have izspocket, nor . ohetuse ECG or jodtip bin ailizmequivalent. in ttaA the DF4–LLHO than eimplantation, the udamage rseand/or kit been nthe caution sPenrose earoconnections, drz. lead zis if dsealing bmnlethe pulse nSnecessary. aonot e damaged ljatkrátunneler kintterminal oterminal eto handling vused, aaljaitirdrain, tgenerator v. ethe ol . integrity lead . eaathey Nikr! w. stsetscrews, tcap forceps, kit during ãterminal, ăi. kwith large iepin, amust the o . e is nthe and . A sterile . even any not aulead Nbchest Nthe lead be . nresult themostats, rieused, surgical other Nilizeuseal when capped u terminal tunneling tray pterminal t tube, kie sin egoeplugs, cap than or e the sloss e ueu. or . before ubwhen the żžand ulead the and yof tívor rpilizuwaolä ikaťra. ćeak. . bnä. yitteäe. . j. nmayın.


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