Estella Pulse Generators - BIOTRONIK USA - News

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112 Estella Pulse Generators Technical Manual12.3 Threshold TestThe pulse generator models are equipped with a high-precisionthreshold test with a resolution of 0.1 V ranging from 0.1 V to 7.5 V.The threshold test is activated as a temporary program whose specificoperation is defined by the applicable software version. The threshold isdetermined by observing the ECG or IEGM. Likewise, all determinationsof threshold or threshold margin, by any means, should only beperformed by use of temporary programming to permit immediatereactivation of the permanent program in case of loss of capture.Removal of the programmer head immediately stops the test andreactivates the permanent program.The threshold test should be performed with the pulse widthprogrammed to the same value as that selected for the permanentprogram. To ensure pacing, the pacing rate of the threshold test programshould exceed the patient’s intrinsic rate.To determine the threshold, the ECG or IEGM must be observedcontinuously. Based on the measured threshold, the pulse amplitudefor the permanent program should be adjusted. Please consult thepertinent medical literature for specific recommendations regardingnecessary safety margins.In addition to the manual ventricular threshold test, the thresholdtest can be performed automatically, requiring no user interaction.The automatic threshold test uses the VCC function to determine thethreshold. Once the threshold is determined, VCC is deactivated if thefeature is not programmed ON in the permanent program.12.4 P/R MeasurementThe pulse generators provide a P-/R-wave test for measuring theamplitude of intrinsic events during follow-up examination. The testdetermines the minimum, mean and maximum amplitude values over aprogrammable period of time. In addition, these values may be printedout.To permit evaluation of the sensing function, the pacing rate must belower than the patient’s intrinsic rate. In demand pacing, the propersensing function can be recognized if the interval between intrinsicevents and the following pacing pulse equals the basic interval (if noHysteresis is programmed).For evaluation of the sensing function, the pulse generator features anintracardiac electrogram (IEGM) with marker signals to indicate sensedand paced events. In addition, triggered pacing modes can be selected,which synchronously to the detection of an intrinsic event, emit a pacingpulse and mark the sensed event and its timing on the ECG.
Estella Pulse Generators Technical Manual 113Especially with unipolar sensing functions, the selected sensitivitylevel should be checked for possible interference from skeletalmyopotentials. If oversensing is observed, the programming of a lowersensitivity (higher value), or bipolar sensing function, if the implantedlead is bipolar, should be evaluated.12.5 Testing for Retrograde ConductionRetrograde conduction from the ventricle to the atrium can be assumedwhen a 1:1 relationship between the ventricular stimulation and atrialdepolarization has been obtained with a constant coupling intervalduring ventricular stimulation. The pulse generator features a test formeasuring retrograde conduction time. During operation of this test,the patient is paced at an increased ventricular rate over several cycleswhile the retrograde conduction time is measured.Both the programmer display and printout provide measured retrogradeconduction times (minimum, mean and maximum). The duration of timethat the test is conducted may be selected.To prevent retrograde P-waves from triggering ventricular pulses,thereby mediating a “re-entry” tachycardia (pacemaker mediatedtachycardia, PMT), the programmed post-ventricular atrial refractoryperiod must be longer than the retrograde conduction time.12.6 Non‐Invasive Programmed Stimulation (NIPS)WarningNIPS—Life threatening ventricular arrhythmias can beinduced by stimulation in the atrium. Ensure that an externalcardiac defibrillator is easily accessible. Only physicianstrained and experienced in tachycardia induction andreversion protocols should use non-invasive programmedstimulation (NIPS).12.6.1 DescriptionThe implanted pulse generator/lead system may be used in conjunctionwith the programmer to generate externally controlled pacing pulses.Burst Stimulation or Programmed Stimulation may be selected with upto four extra stimuli at pacing rates to 800 ppm.
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ContentsEstella Pulse Generators Te
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Estella Pulse Generators Technical
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1. Device DescriptionEstella Pulse
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2. IndicationsEstella Pulse Generat
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4. Warnings and PrecautionsEstella
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5. Adverse EventsNOTE:Estella Pulse
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7.2.3 Scan HysteresisEstella Pulse
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7.5.3.2 AV HysteresisEstella Pulse
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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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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
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Page 143 and 144: 16. Order InformationPulse Generato
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Page 154: Manufactured by:BIOTRONIK SE & Co.
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