Lumax Family of ICDs and CRTâDs - BIOTRONIK USA - News
Lumax Family of ICDs and CRTâDs - BIOTRONIK USA - News
Lumax Family of ICDs and CRTâDs - BIOTRONIK USA - News
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4 <strong>Lumax</strong> <strong>Family</strong> Technical Manual<br />
1.3 Contraindications<br />
The <strong>Lumax</strong> devices are contraindicated for use in patients with the<br />
following conditions:<br />
• Patients whose ventricular tachyarrhythmias may have transient or<br />
reversible causes such as:<br />
--<br />
Acute myocardial<br />
infarction<br />
--<br />
Digitalis intoxication<br />
--<br />
Drowning<br />
--<br />
Electrocution<br />
--<br />
Electrolyte imbalance<br />
--<br />
Hypoxia<br />
--<br />
Sepsis<br />
• Patients with incessant ventricular fibrillation (VF) <strong>and</strong> ventricular<br />
tachycardia (VT)<br />
• Patients whose only disorder is brady arrhythmias or atrial<br />
arrhythmias<br />
1.4 Warnings <strong>and</strong> Precautions<br />
MRI (Magnetic Resonance Imaging)—Do not expose a patient to MRI<br />
device scanning. Strong magnetic fields may damage the device <strong>and</strong><br />
cause injury to the patient.<br />
Electrical Isolation—To prevent inadvertent arrhythmia induction,<br />
electrically isolate the patient during the implant procedure from<br />
potentially hazardous leakage currents.<br />
Left Ventricular Lead Systems—<strong>BIOTRONIK</strong> CRT‐Ds may be implanted<br />
with any legally marketed, compatible LV lead. Compatibility is defined<br />
as:<br />
• IS‐1 pacing connector<br />
• Active or passive fixation technology<br />
• Insertion <strong>and</strong> withdrawal forces as specified by ISO 5841‐3 (IS‐1)
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