Renamic - BIOTRONIK USA - News

More documents

Recommendations

Info

14 General Safety InstructionsElectrostatic potentialsEnsure that electrostatic potentials between medical staffand patients are balanced. Before handling the device, theelectrostatic potential between the doctor or medical staffand the patient must be balanced by touching the patient at apoint as far away from the leads as possible.Leakage currentsAvoid leakage currents between all connected devices, thepatient cable, and the patient if line-powered devices areused in the vicinity of the patient. Such leakage currents maytrigger lethal arrhythmias.Potential equalization cables, if present, must be attached toall connected components.National and international regulations concerning the use ofelectromedical devices also apply to patient cables.Threshold testExamine the patient's health before performing a thresholdtest. A loss of capture, asystole and pacing during thevulnerable periods can occur.Termination of pacingDo not abruptly terminate pacing. The sudden terminationof pacing can lead to extended periods of asystole in somepatients. Gradually decrease the pacing rate until thepatient's intrinsic rate is detected.Mode selectionSelect a mode that is consistent with the patient cableconnections to the leads. Loss of pacing could cause dangerto the patient.
15 General Safety InstructionsWenckebach testSince atrial single-chamber pacing is contraindicated for usein patients with no AV conduction, the Wenckebach test mustnot be performed on these patients.Burst pacingBurst pacing can induce or accelerate dangerousarrhythmias. Always have emergency resuscitationequipment immediately available when using this feature.Using in combination with radio frequency devicesWhile the device is designed and tested for limited protectionfrom the effects of high-frequency surgery, disconnect thepatient cables from the pacing leads when performing anelectrosurgical procedure whenever possible. Use of RFsurgery equipment may damage the device and/or inducedangerous currents in the patient cable which can beconducted into the patient’s heart. Perform an inspectionof <strong>Renamic</strong> and the PSA module after use with RF surgeryequipment.DefibrillationWhen connected with the authorized cables, the device isdefibrillation protected. During defibrillation, do not touchthe patient, the programmer the patient is connected to orthe attached accessories. Otherwise, there is a danger thatyou may suffer an electrical shock. Following a defibrillation,check all functions of the device.ElectrocauteryDisconnect the patient cables from the leads duringelectrocautery even though the device has been designedto provide protection against such effects. If the device isconnected to the patient during electrocautery, check theoperation of the <strong>Renamic</strong> and the PSA module afterwards forproper functioning.
Page 3 and 4: 1Table of ContentsIndications for U
Page 5 and 6: 3 Table of ContentsSupplementary In
Page 7: 5Indications and Contraindications
Page 11: 9 Warnings and Precautionstouching
Page 14 and 15: 12 General Safety InstructionsGener
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
Page 56 and 57: 54 Renamic PSAFigure 25: Threshold
Page 58 and 59: 56 Renamic PSAFigure 27: Adjust scr
Page 60: 58 Renamic PSAFigure 28: The Freeze
Page 63 and 64: 61 Renamic PSAFigure 31: ID NumberF
Page 65: 63 Renamic PSAFigure 34: Date of Bi
Page 68 and 69:
66 Renamic PSAHospitaland CityThe h
Page 71 and 72:
69 Renamic PSATypeThe type of lead
Page 73 and 74:
71 Renamic PSAIf a device is interr
Page 75 and 76:
73 MaintenanceMaintenanceTo clean a
Page 77 and 78:
75 SafetyOperatingConditions• Do
Page 79 and 80:
77 Technical DataTechnical DataSee
Page 81 and 82:
79 Technical DataInternal printerCa
Page 83 and 84:
81 Supplementary InformationSupplem
Page 85 and 86:
83 Supplementary InformationUL-cert
Page 88 and 89:
86 Symbols on the ComponentsThe sym
Page 90 and 91:
88 Symbols on the ComponentsLegend
Page 94:
M4147-B 07/13© 2013 BIOTRONIK, Inc
show all

Renamic - BIOTRONIK USA - News

Create successful ePaper yourself

Delete template?

Save as template?