Renamic - BIOTRONIK USA - News

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4Indications and Contraindications for UseNote: Federal (USA) law restricts this device to sale by, or onthe order of, a physician.Indications for UseThe Renamic programmer is indicated for use with BIOTRONIKpacemakers and defibrillators. Therefore, the indications foruse for the specific implantable devices are applicable.Intended UseRenamic provides communication with the implantable pulsegenerator or ICD during the implantation procedure or followups.Renamic is intended to be used for the following tasks:• Conduct sensing, pacing threshold, and impedance tests• Interrogate data of the implanted device, such asprogram parameters, recorded statistical data, episodes,as well as real-time IEGMs• Display, printout, save and export data of the implanteddevice for analysis and reporting purposes• Transfer parameters to the implanted deviceThe Renamic programmer with PSA module is intended to beused for the following tasks:• Evaluation of the position and integrity of leads• Determination of appropriate pacing parameters for theimplanted deviceFor this intended purpose, the device provides the followingmeasurement/diagnostic functions:• For the sensing of intrinsic cardiac events:ооP/R wave amplitudes and slew rateооRates (PP, PR interval)ооIntrinsic AV delay (PR interval)ооConduction times (antegrade, retrograde)
5Indications and Contraindications for UseооWenckebach pointооVV delay• For the pacing of the heart:ооPacing threshold in up to 3 chambersооLead impedancesооBurst pacingContraindicationsPlease refer to the contraindications in the Technical Manualof the specific implantable devices.
Page 3 and 4: 1Table of ContentsIndications for U
Page 5: 3 Table of ContentsSupplementary In
Page 11: 9 Warnings and Precautionstouching
Page 14 and 15: 12 General Safety InstructionsGener
Page 16 and 17: 14 General Safety InstructionsElect
Page 18 and 19: 16 General Safety InstructionsSensi
Page 20 and 21: 18 Device OverviewDevice OverviewAn
Page 22 and 23: 20 Device OverviewFigure 3: Power c
Page 25 and 26: 23 Start UpECG Port and USB Device
Page 28 and 29: 26 Start UpWhen possible, use the O
Page 30 and 31: 28 Using RenamicEmergencyProgramsRe
Page 32 and 33: 30 Using RenamicTelemetryThe progra
Page 34 and 35: 32 Using RenamicLED Status (flashin
Page 36 and 37: 34 Using RenamicUsing theInternal P
Page 38 and 39: 36 Using RenamicPrintingFigure 12:
Page 40 and 41: 38 Renamic PSAOverviewRenamic PSATh
Page 42 and 43: 40 Renamic PSAConnecting thepatient
Page 44 and 45: 42 Renamic PSAa. Rate - current rat
Page 46 and 47: 44 Renamic PSAParameter Range Remar
Page 48 and 49: 46 Renamic PSAFigure 17: Saving mea
Page 50 and 51: 48 Renamic PSAFigure 19: Burst paci
Page 52 and 53: 50 Renamic PSAFigure 21: Completed
Page 54 and 55: 52 Renamic PSAFigure 23: Sensing te
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54 Renamic PSAFigure 25: Threshold
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56 Renamic PSAFigure 27: Adjust scr
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58 Renamic PSAFigure 28: The Freeze
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61 Renamic PSAFigure 31: ID NumberF
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63 Renamic PSAFigure 34: Date of Bi
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66 Renamic PSAHospitaland CityThe h
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69 Renamic PSATypeThe type of lead
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71 Renamic PSAIf a device is interr
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73 MaintenanceMaintenanceTo clean a
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75 SafetyOperatingConditions• Do
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77 Technical DataTechnical DataSee
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79 Technical DataInternal printerCa
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81 Supplementary InformationSupplem
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83 Supplementary InformationUL-cert
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86 Symbols on the ComponentsThe sym
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88 Symbols on the ComponentsLegend
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M4147-B 07/13© 2013 BIOTRONIK, Inc
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Renamic - BIOTRONIK USA - News

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