Estella Pulse Generators - BIOTRONIK USA - News

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8 Estella Pulse Generators Technical ManualDefibrillation—The following precautions are recommended tominimize the inherent risk of pulse generator operation being adverselyaffected by defibrillation:• The paddles should be placed anterior‐posterior or along a lineperpendicular to the axis formed by the pulse generator and theimplanted lead.• The energy setting should not be higher than required to achievedefibrillation.• The distance between the paddles and the pacer/electrode(s) shouldnot be less than 10 cm (4 inches).Radiation—Pulse generator electronics may be damaged by exposureto radiation during radiotherapy. To minimize this risk when using suchtherapy, the pulse generator should be protected with local radiationshielding.Lithotripsy—Lithotripsy treatment should be avoided for pacemakerpatients since electrical and/or mechanical interference with the pulsegenerator is possible. If this procedure must be used, the greatestpossible distance from the point of electrical and mechanical strainshould be chosen in order to minimize a potential interference with thepulse generator.Electrocautery—Electrocautery should never be performed within 15 cm(6 inches) of an implanted pulse generator or lead because of the dangerof introducing fibrillatory currents into the heart and/or damaging thepulse generator. Pacing should be asynchronous and above the patient’sintrinsic rate to prevent inhibition by interference signals generated bythe cautery. When possible, a bipolar electrocautery system should beused.For transurethral resection of the prostate, it is recommended thatthe cautery ground plate be placed under the buttocks or around thethigh, but not in the thoracic area where the current pathway could passthrough or near the pacing system.4.2 Storage and SterilizationStorage (temperature)—Recommended storage temperature range is5° to 55°C (41°-131°F). Exposure to temperatures outside this rangemay result in pulse generator malfunction (see Section 10.1).Handling—Do not drop. If an unpackaged pulse generator is droppedonto a hard surface, return it to BIOTRONIK (see Section 10.1).FOR SINGLE USE ONLY—Do not resterilize the pulse generator oraccessories packaged with the pulse generator, they are intended forone-time use.
Estella Pulse Generators Technical Manual 9Device Packaging—Do not use the device if the packaging is wet,punctured, opened or damaged because the integrity of the sterilepackaging may be compromised. Return the device to BIOTRONIK.Storage (magnets)—Store the device in a clean area, away frommagnets, kits containing magnets, and sources of electromagneticinterference (EMI) to avoid damage to the device.Temperature Stabilization—Allow the device to reach room temperaturebefore programming or implanting the device. Temperature extremesmay affect the initial device function.Use Before Date—Do not implant the device after the USE BEFOREDATE because the device sterility and longevity may be compromised.4.3 Lead Connection and EvaluationThe pulse generator requires atrial and ventricular leads with IS-1compatible connectors. There are no requirements specific to the atriallead. It is required to use a low polarization ventricular lead for activationof Ventricular Capture Control.Lead Check—The Estella pulse generators have an automatic lead checkfeature which may switch from bipolar to unipolar pacing and sensingwithout warning. This situation may be inappropriate for patients withan Implantable Cardioverter Defibrillator (ICD).Lead/pulse Generator Compatibility—Because of the numerousavailable 3.2-mm configurations (e.g., the IS-1 and VS‐1 standards),lead/pulse generator compatibility should be confirmed with the pulsegenerator and/or lead manufacturer prior to the implantation of apacing system.IS-1, wherever stated in this manual, refers to the internationalstandard, whereby leads and generators from different manufacturersare assured a basic fit. [Reference ISO 5841-3:1992(E)].Lead Configuration—Lead configuration determines properprogramming of the pulse generator. Pacing will not occur with aunipolar lead if the lead configuration is programmed to bipolar (seeSection 11).Setscrew Adjustment—Back-off the setscrew(s) prior to insertion oflead connector(s) as failure to do so may result in damage to the lead(s),and/or difficulty connecting lead(s).Cross Threading Setscrew(s)—To prevent cross threading thesetscrew(s), do not back the setscrew(s) completely out of the threadedhole. Leave the torque wrench in the slot of the setscrew(s) while thelead is inserted.
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: 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 and 58: 7.2.3 Scan HysteresisEstella Pulse
Page 65 and 66: 7.5.3.2 AV HysteresisEstella Pulse
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Estella Pulse Generators Technical
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Figure 13: Automatic Sensor GainEst
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Table 20: Rate DecreaseDecrease inR
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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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