Estella Pulse Generators - BIOTRONIK USA - News

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104 Estella Pulse Generators Technical Manual9.5 Position IndicatorThe position indicator facilitates positioning of the programmer head.The programmer optically and acoustically indicates whether theprogrammer head is in communication with the pulse generator.9.6 Pacing When Exposed to InterferenceCautionEMI—Computerized systems are subject to EMI or “noise”. Inthe presence of such interference, telemetry communicationmay be interrupted and prevent programming.A sensed event occurring during the interference interval willcontinuously reset that interval for the corresponding chamber withoutresetting the basic interval. Depending upon whether the interference(electromagnetic interference, muscle potentials, etc.) is detected by theatrial and/or ventricular channel, atrial and/or ventricular asynchronouspacing at the programmed timing intervals will result for the duration ofthe interference. The interference interval has a duration of 51 ms.Depending on the programmed pacing mode and the channel in whichelectromagnetic interference (EMI) occurs, Table 30 details the resultingpacing modes for the duration of exposure to EMI.Table 30: Response to EMIMODE EMI* (A) EMI* (V) EMI* (A+V)DDD(R)DDI(R)DVI(R)VDD(R)VVI(R)AAI(R)DDTVDIVVTAATDVDR---DVD(R)DVI(R)---VVI(R)---AOO(R)VVTVVT---AOODADRVOORDAD(R)DAI(R)DOO(R)VAT(R)VOO(R)---VATVOOVOO---DOOR---DOO(R)DOO(R)---VOO(R)------VOOVOO------* EMI = Electromagnetic Interference
10. Product Storage and Handling10.1 Sterilization and StorageEstella Pulse Generators Technical Manual 105The pulse generator is shipped in a cardboard box, equipped with aquality control seal and product information label. The label containsthe model specifications, technical data, serial number, expiration date,and sterilization and storage information of the pulse generator. Thebox contains a double container with the pulse generator and productdocumentation.The pulse generator and its accessories have been sealed in a containerand gas sterilized with ethylene oxide. To assure sterility, the containershould be checked for integrity prior to opening. If a breach of sterility issuspected, return the pulse generator to BIOTRONIK.CautionStorage (temperature)—Recommended storage temperaturerange is 5° to 55°C (41°-131°F). Exposure to temperaturesoutside this range may result in pulse generator malfunction.Handling—Do not drop. If an unpackaged pulse generator isdropped onto a hard surface, return it to BIOTRONIK.CautionFOR SINGLE USE ONLY—Do not resterilize the pulse generatoror accessories packaged with the pulse generator, they areintended for one-time use.Device Packaging—Do not use the device if the packaging iswet, punctured, opened or damaged because the integrity of thesterile packaging may be compromised. Return the device toBIOTRONIK.Storage (magnets)—Store the device in a clean area, awayfrom magnets, kits containing magnets, and sources ofelectromagnetic interference (EMI) to avoid damage to thedevice.Use Before Date—Do not implant the device after the USEBEFORE DATE because the device may have reduced longevity.If a replacement pulse generator is needed, contact your localBIOTRONIK representative.
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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. Programmable ParametersEstella P
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7.2.3 Scan HysteresisEstella Pulse
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Page 65 and 66: 7.5.3.2 AV HysteresisEstella Pulse
Page 71 and 72: Figure 13: Automatic Sensor GainEst
Page 73 and 74: Table 20: Rate DecreaseDecrease inR
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Page 79 and 80: Table 21: Acronyms and TermsCVATMTe
Page 109 and 110: 9. Other Functions/FeaturesEstella
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Page 119 and 120: 12. Follow-up Procedures12.1 Genera
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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
Page 141 and 142: ParameterEstella Pulse Generators T
Page 143 and 144: 16. Order InformationPulse Generato
Page 149 and 150: The AAI mode is conditionally indic
Page 154: Manufactured by:BIOTRONIK SE & Co.
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