Estella Pulse Generators - BIOTRONIK USA - News

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14 Estella Pulse Generators Technical ManualCommercial Electrical Equipment—Commercial electrical equipmentsuch as arc welders, induction furnaces, or resistance welders maygenerate enough EMI to interfere with pulse generator operation ifapproached too closely.Electrical Appliances—Electric hand-tools and electric razors (useddirectly over the skin of the pulse generator) have been reported tocause pulse generator disturbances. Home appliances that are in goodworking order and properly grounded do not usually produce enoughEMI to interfere with pulse generator operation.Electronic Article Surveillance (EAS)—Equipment such as retail theftprevention systems may interact with the pulse generators. Patientsshould be advised to walk directly through and not to remain near anEAS system longer than necessary.4.6.2 Cellular PhonesRecent studies have indicated there may be a potential interactionbetween cellular phones and pulse generator operation. Potential effectsmay be due to either the radio frequency signal or the magnet withinthe phone and could include inhibition or asynchronous pacing when thephone is within close proximity (within 6 inches [15 centimeters]) to thepulse generator.Based on testing to date, effects resulting from an interaction betweencellular phones and the implanted pulse generators have beentemporary. Simply moving the phone away from the implanted devicewill return it to its previous state of operation. Because of the greatvariety of cellular phones and the wide variance in patient physiology, anabsolute recommendation to cover all patients cannot be made.Patients having an implanted pulse generator who operate a cellularphone should:• Maintain a minimum separation of 6 inches (15 centimeters)between a hand-held personal cellular phone and the implanteddevice. Portable and mobile cellular phones generally transmit athigher power levels compared to hand held models. For phonestransmitting above 3 watts, maintain a minimum separation of 12inches (30 centimeters) between the antenna and the implanteddevice.• Patients should hold the phone to the ear opposite the side of theimplanted device. Patients should not carry the phone in a breastpocket or on a belt over or within 6 inches (15 centimeters) of theimplanted device as some phones emit signals when they are turnedON but not in use (i.e., in the listen or standby mode). Store thephone in a location opposite the side of implant.
Estella Pulse Generators Technical Manual 154.6.3 Hospital and Medical EnvironmentsElectrosurgical Cautery—Electrosurgical cautery could induceventricular arrhythmias and/or fibrillation, or may cause asynchronousor inhibited pulse generator operation. If use of electrocautery isnecessary, the current path (ground plate) should be kept as far awayfrom the pulse generator and leads as possible.Lithotripsy—Lithotripsy may damage the pulse generator. If lithotripsymust be used, do not focus the beam near the pulse generator.External Defibrillation—External defibrillation may damage the pulsegenerator. Attempt to minimize current flowing through the pulsegenerator and lead system by following the precautions.High Radiation Sources—High radiation sources such as cobalt 60 orgamma radiation should not be directed at the pulse generator. If apatient requires radiation therapy in the vicinity of the pulse generator,place lead shielding over the device to prevent radiation damage.4.7 Pulse Generator Explant and DisposalDevice Incineration—Never incinerate a pulse generator. Be sure thepulse generator is explanted before a patient who has died is cremated(see Section 14).Explanted Devices—Return all explanted devices to BIOTRONIK.
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
Page 71 and 72: 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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