Estella Pulse Generators - BIOTRONIK USA - News

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12 Estella Pulse Generators Technical ManualTriggered Modes—While the triggered modes (DDT, VVT, and AAT) canbe programmed permanently, the use of these modes is intended as atemporary setting in situations where maintaining the programminghead in place would be impossible or impractical (i.e., during exercisetesting or extended Holter monitoring) or as a short term solution topulse generator inhibition by extracardiac interference. To avoid thepotential for early battery depletion, it is important that the triggeredmodes are not used for long term therapy, and that the pulse generatoris returned to a non-triggered permanent program.4.5 Home MonitoringBIOTRONIK’s Home Monitoring system is designed to notify clinicians inless than 24 hours of changes to the patient’s condition or status of theimplanted device. Updated data may not be available if:• The patient’s CardioMessenger is off or damaged and is not able toconnect to the Home Monitoring system through an active telephonelink.• The CardioMessenger cannot establish a connection to theimplanted device.• The telephone and/or Internet connection do not operate properly• The Home Monitoring Service Center is off-line (upgrades aretypically completed in less than 24 hours)Patient’s Ability—Use of the Home Monitoring system requires thepatient and/or caregiver to follow the system instructions and cooperatefully when transmitting data.If the patient cannot understand or follow the instructions becauseof physical or mental challenges, another adult who can follow theinstructions will be necessary for proper transmission.Electromagnetic Interference (EMI)—Precautions for EMI interferencewith the Estella DR‐T pulse generator are provided in Section 4.6.Sources of EMI including cellular telephones, electronic articlesurveillance systems, and others are discussed therein.Use in Cellular Phone Restricted Areas—The mobile patient device(transmitter/receiver) should not be utilized in areas where cellularphones are restricted or prohibited (i.e., commercial aircraft).4.6 Electromagnetic Interference (EMI)The operation of any implanted pulse generator may be affected bycertain environmental sources generating signals that resemble cardiacactivity. This may result in pulse generator pulse inhibition and/ortriggering or in asynchronous pacing depending on the pacing mode and
Estella Pulse Generators Technical Manual 13the interference pattern. In some cases (i.e., diagnostic or therapeuticmedical procedures), the interference sources may couple sufficientenergy into a pacing system to damage the pulse generator and/orcardiac tissue adjacent to the electrodes.BIOTRONIK pulse generators have been designed to significantly reducesusceptibility to electromagnetic interference (EMI). However, due tothe variety and complexity of sources creating interference, there isno absolute protection against EMI. Generally, it is assumed that EMIproduces only minor effects, if any, in pacemaker patients. If the patientpresumably will be exposed to one of the following environmentalconditions, then the patient should be given the appropriate warnings.4.6.1 Home and Occupational EnvironmentsThe following equipment (and similar devices) may affect normal pulsegenerator operation: electric arc welders, electric melting furnaces,radio/television and radar transmitters, power‐generating facilities,high‐voltage transmission lines, electrical ignition systems (alsoof gasoline‐powered devices) if protective hoods, shrouds, etc., areremoved, electrical tools, anti‐theft devices of shopping centers andelectrical appliances, if not in proper condition or not correctly groundedand encased.Patients should exercise reasonable caution in avoidance of deviceswhich generate a strong electric or magnetic field. If EMI inhibitsoperation of a pulse generator or causes it to revert to asynchronousoperation at the programmed pacing rate or at the magnet rate, movingaway from the source or turning it off will allow the pulse generator toreturn to its normal mode of operation. Some potential EMI sourcesinclude:High Voltage Power Transmission Lines—High voltage powertransmission lines may generate enough EMI to interfere with pulsegenerator operation if approached too closely.Home Appliances—Home appliances normally do not affect pulsegenerator operation if the appliances are in proper condition andcorrectly grounded and encased. There are reports of pulse generatordisturbances caused by electrical tools and by electric razors that havetouched the skin directly over the pulse generator.Communication Equipment—Communication equipment such asmicrowave transmitters, linear power amplifiers, or high-poweramateur transmitters may generate enough EMI to interfere with pulsegenerator operation if approached too closely.
Page 1 and 2: BIOTRONIKEstella Pulse GeneratorsTe
Page 3 and 4: ContentsEstella Pulse Generators Te
Page 5 and 6: 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
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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 and 58: 7.2.3 Scan HysteresisEstella Pulse
Page 65 and 66: 7.5.3.2 AV HysteresisEstella Pulse
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Figure 13: Automatic Sensor GainEst
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Table 20: Rate DecreaseDecrease inR
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Estella Pulse Generators Technical
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7.11.2.1 PMT Detection and Terminat
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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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