Estella Pulse Generators - BIOTRONIK USA - News

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50 Estella Pulse Generators Technical Manual7.2.4 Repetitive HysteresisRepetitive hysteresis is expanded programmability of the Hysteresisfeature. Repetitive hysteresis searches for an underlying intrinsiccardiac rhythm, which may exist slightly below the programmed lowerrate (or sensor-indicated rate) of the patient. Following 180 consecutivesensed events, this feature allows the intrinsic rhythm to drop to orbelow the hysteresis rate. During the time when the intrinsic rate isat or below the hysteresis rate, pacing occurs at the hysteresis ratefor the programmed number of beats (up to 15). Should the numberof programmed beats be exceeded, the stimulation rate returns to thelower rate (or sensor-indicated rate).If an intrinsic cardiac rhythm is detected within the programmed numberof beats between the hysteresis rate and the lower rate, the intrinsicrhythm is allowed and inhibits the pulse generator.Figure 8: Repetitive HysteresisRepetitive hysteresis has been incorporated to promote spontaneouscardiac rhythm and may reduce pulse generator energy consumption.NOTE:Repetitive Hysteresis can be used during night mode but it will nottake the rate below the programmed night rateRepetitive Hysteresis is only available when Hysteresis is selectedon.There is one Standard Hysteresis interval which occurs before theprogrammable number of Repetitive Hysteresis occur.
Estella Pulse Generators Technical Manual 517.2.5 Night ModeProgrammable Night Time Begin and End in 10 minute steps.The Night Mode feature allows a temporary reduction of the base rateduring normal sleeping hours. If selected, the base rate is gradually andtemporarily reduced to the programmed night pacing rate. At the end ofnight mode, the base rate gradually returns to the original values.The Night Mode feature has been incorporated to allow the patient’sspontaneous night rhythm and may reduce pulse generator energyconsumption.NOTE:When Night Mode and Ventricular Capture Control are programmedON simultaneously in VVI(R), VCC will not take the rate below theprogrammed night rateOver time, the pulse generator’s internal time-of-day clock willexhibit a discrepancy with the actual time (less than 1 hour peryear). This will cause a corresponding discrepancy between theprogrammed bed and wake times and the actual times that thesystem changes the rate.The programmer automatically updates the pulse generator timeof‐dayclock each time the pulse generator is programmed.The actual time when the respective increase or decrease in rateoccurs may begin up to 4 minutes after the programmed timebecause of internal pulse generator timing.7.2.6 Rate FadingRate Fading is intended to prevent a sudden drop in heart rate when thepulse generator transitions from tracking an intrinsic rhythm to pacingdue to an abrupt decrease in the intrinsic rate, in order to preventpotential reactions such as dizziness, light headedness, lack of energyand fainting.With Rate Fading enabled, the pulse generator calculates the FadingRate, which is a four beat average of the intrinsic rate reduced by 10ppm. When the intrinsic rate drops considerably (below the Fading Rate),the pacing rate begins at the RF rate and then decreases gradually bythe programmable Decay Rate to the Sensor Indicated Rate or BasicRate. This behavior is illustrated in Figure 9.NOTE:The Fading Rate cannot exceed the programmed MaximumActivity Rate and cannot increase faster than the RF Rate decrease(programmable in ppm/cycle).
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BIOTRONIKEstella Pulse GeneratorsTe
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ContentsEstella Pulse Generators Te
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Estella Pulse Generators Technical
Page 7 and 8: Estella Pulse Generators Technical
Page 9 and 10: 1. Device DescriptionEstella Pulse
Page 11 and 12: 2. IndicationsEstella Pulse Generat
Page 15 and 16: 4. Warnings and PrecautionsEstella
Page 25 and 26: 5. Adverse EventsNOTE:Estella Pulse
Page 35 and 36: 6.2.4 Clinical Study ConclusionsEst
Page 49 and 50: 6.4.4.7 Additional Study ResultsEst
Page 53 and 54: 7. Programmable ParametersEstella P
Page 57: 7.2.3 Scan HysteresisEstella Pulse
Page 65 and 66: 7.5.3.2 AV HysteresisEstella Pulse
Page 71 and 72: Figure 13: Automatic Sensor GainEst
Page 73 and 74: Table 20: Rate DecreaseDecrease inR
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Page 79 and 80: Table 21: Acronyms and TermsCVATMTe
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9. Other Functions/FeaturesEstella
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10. Product Storage and Handling10.
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11. Lead ConnectionEstella Pulse Ge
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12. Follow-up Procedures12.1 Genera
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Table 33: Nominal Pulse Generator L
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14. ExplantationEstella Pulse Gener
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AV Repetitive Hysteresis (Dual cham
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Periodic TransmissionOff, 30, 60, 9
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ParameterEstella Pulse Generators T
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16. Order InformationPulse Generato
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The AAI mode is conditionally indic
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Manufactured by:BIOTRONIK SE & Co.
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