Estella Pulse Generators - BIOTRONIK USA - News

More documents

Recommendations

Info

118 Estella Pulse Generators Technical ManualTable 32: Pulse Generator Behavior after Reaching ERIMagnet ModeAutomaticAsynchronousSynchronousCycles 1-10 aftermagnet applicationAsynchronous, basicrate at 80 ppmAsynchronous, basicrate at 80 ppmSynchronized withbasic rate reduced by4.5—11%After Cycle 10Synchronized withbasic rate reduced by4.5—11%Asynchronous withbasic rate at 80Synchronized withbasic rate reduced by4.5—11%If the pulse generator is programmed to dual chamber pacing, itwill switch to single chamber pacing when it reaches the electivereplacement indication. The “ERI mode” varies according to theprogrammed pacing mode and is indicated by the pulse generator.CautionHigh output settings combined with very low lead impedance mayreduce the life expectancy of the pulse generator to less than1 year. Programming of pulse amplitudes, higher than 4.8 V, incombination with long pulse widths and/or high pacing rates canlead to premature activation of the replacement indicatorTable 33 shows the expected longevity (in years) from BOS to ERI forEstella pulse generators. The programmer software for the Estellapulse generators provides an estimated time to ERI in months and yearsthat is updated each time the device is reprogrammed. This estimationallows the physician to understand the longevity effects of modifyingprogrammed parameters.
Table 33: Nominal Pulse Generator LongevityAmplitudeImpedance(Ohms)Estella Pulse Generators Technical Manual 119Pacing10% 50% 100%2.5 V 500DR(-T)SR(-T)DR(-T)SR(-T)DR(-T)SR(-T)12.1 15.0 10.7 14.1 8.2 11.9The mean* expected time intervals from ERI to EOS at standardprogram for Estella pulse generators is 6 months. All service intervals,including the above-cited nominal pulse generator longevity, arebased on considerations that consider the battery discharge behaviorand the hybrid circuit properties including current consumption andreplacement indicator. The statistical calculations are based on a basicrate of 60 ppm, pulse width of 0.4 ms, shelf life of 1.5 years, and datasupplied by the battery manufacturer.* 50% of all pacemakers reach or exceed the given value
Page 1 and 2:
BIOTRONIKEstella Pulse GeneratorsTe
Page 3 and 4:
ContentsEstella Pulse Generators Te
Page 5 and 6:
Estella Pulse Generators Technical
Page 7 and 8:
Page 9 and 10:
1. Device DescriptionEstella Pulse
Page 11 and 12:
2. IndicationsEstella Pulse Generat
Page 13 and 14:
Page 15 and 16:
4. Warnings and PrecautionsEstella
Page 17 and 18:
Page 19 and 20:
Page 21 and 22:
Page 23 and 24:
Page 25 and 26:
5. Adverse EventsNOTE:Estella Pulse
Page 27 and 28:
Page 29 and 30:
Page 33 and 34:
Page 35 and 36:
6.2.4 Clinical Study ConclusionsEst
Page 37 and 38:
Page 39 and 40:
Page 41 and 42:
Page 43 and 44:
Page 45 and 46:
Page 47 and 48:
Page 49 and 50:
6.4.4.7 Additional Study ResultsEst
Page 51 and 52:
Page 53 and 54:
7. Programmable ParametersEstella P
Page 55 and 56:
Page 57 and 58:
7.2.3 Scan HysteresisEstella Pulse
Page 59 and 60:
Page 61 and 62:
Page 63 and 64:
Page 65 and 66:
7.5.3.2 AV HysteresisEstella Pulse
Page 67 and 68:
Page 69 and 70:
Page 71 and 72:
Figure 13: Automatic Sensor GainEst
Page 73 and 74:
Table 20: Rate DecreaseDecrease inR
Page 75 and 76: Estella Pulse Generators Technical
Page 77 and 78: 7.11.2.1 PMT Detection and Terminat
Page 79 and 80: Table 21: Acronyms and TermsCVATMTe
Page 109 and 110: 9. Other Functions/FeaturesEstella
Page 113 and 114: 10. Product Storage and Handling10.
Page 115 and 116: 11. Lead ConnectionEstella Pulse Ge
Page 119 and 120: 12. Follow-up Procedures12.1 Genera
Page 125: Estella Pulse Generators Technical
Page 129 and 130: 14. ExplantationEstella Pulse Gener
Page 135 and 136: AV Repetitive Hysteresis (Dual cham
Page 139 and 140: Periodic TransmissionOff, 30, 60, 9
Page 141 and 142: ParameterEstella Pulse Generators T
Page 143 and 144: 16. Order InformationPulse Generato
Page 149 and 150: The AAI mode is conditionally indic
Page 154: Manufactured by:BIOTRONIK SE & Co.
show all

Estella Pulse Generators - BIOTRONIK USA - News

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?