Estella Pulse Generators - BIOTRONIK USA - News

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