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Lumax Family of ICDs and CRT‑Ds - BIOTRONIK USA - News

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8 <strong>Lumax</strong> <strong>Family</strong> Technical Manual<br />

Programmers—Use only <strong>BIOTRONIK</strong> ICS 3000 programmers to<br />

communicate with the device.<br />

Sealing System—Failure to properly insert the torque wrench into the<br />

perforation at an angle perpendicular to the connector receptacle may<br />

result in damage to the sealing system <strong>and</strong> its self‐sealing properties.<br />

Defibrillation Threshold—Be aware that changes in the patient’s<br />

condition, drug regimen, <strong>and</strong> other factors may change the defibrillation<br />

threshold (DFT) which may result in non‐conversion <strong>of</strong> the arrhythmia<br />

post‐operatively. Successful conversion <strong>of</strong> ventricular fibrillation or<br />

ventricular tachycardia during arrhythmia conversion testing is no<br />

assurance that conversion will occur post‐operatively.<br />

Manual Shocks—User‐comm<strong>and</strong>ed shocks may be withheld if the<br />

ICD⁄CRT‐D is already busy processing a manual comm<strong>and</strong> or the Battery<br />

Status is low.<br />

Charge Time—When preparing a high energy shock the charge circuit<br />

stops charging the capacitors after 20 seconds, <strong>and</strong> delivers the stored<br />

energy as shock therapy. After the device reaches ERI the stored energy<br />

may be less than the maximum programmable energy for each shock.<br />

Programming W<strong>and</strong> Separation Distance—The w<strong>and</strong> (with magnet)<br />

must not be placed closer than 2 cm to the device (implanted or out <strong>of</strong><br />

the box). Programming w<strong>and</strong> (with magnet) distance closer than 2 cm<br />

may damage the device.<br />

Shipment Mode—The shipment mode is a factory set mode that<br />

controls the charge current <strong>of</strong> automatic capacitor reformations.<br />

This mode controls the charge current to avoid temporary low battery<br />

readings. The shipment mode is automatically deactivated as soon as<br />

electrophysiological tests (e.g., Impedance measurement) have been<br />

performed. To ensure delivery <strong>of</strong> programmed shock energy, make sure<br />

shipment mode is disabled prior to completion <strong>of</strong> implant procedure.<br />

Shock Therapy Confirmation—Programming CONFIRMATION to OFF<br />

may increase the incidence <strong>of</strong> the ICD⁄CRT‐D delivering inappropriate<br />

shocks.<br />

Shock Impedance—If the shock impedance is less than twenty‐five<br />

ohms (25 Ω), reposition the lead system to allow a greater distance<br />

between the electrodes. Never implant the device with a lead system<br />

that has measured shock impedance <strong>of</strong> less than twenty‐five ohms<br />

(25 Ω). Damage to the device may result.

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