User Manual

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Lumax Technical Manual 5
Intraventricular conduction delay (QRS duration 130 ms)
The Lumax Implantable Cardioverter Defibrillators (ICDs) and
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are
intended to provide ventricular anti-tachycardia pacing and
ventricular defibrillation, for automated treatment of life-
threatening ventricular arrhythmias.
1.3 Contraindications
The Lumax devices are contraindicated for use in patients with
the following conditions:
Patients whose ventricular tachyarrhythmias may have
transient or reversible causes such as:
Acute myocardial infarction
Digitalis intoxication
Drowning
Electrocution
Electrolyte imbalance
Hypoxia
Sepsis
Patients with incessant ventricular fibrillation (VF) and
ventricular tachycardia (VT)
Patients whose only disorder is brady arrhythmias or
atrial arrhythmias
1.4 Warnings and Precautions
MRI (Magnetic Resonance Imaging) - Do not expose a patient
to MRI device scanning. Strong magnetic fields may damage the
device and cause injury to the patient.
Electrical Isolation - To prevent inadvertent arrhythmia
induction, electrically isolate the patient during the implant
procedure from potentially hazardous leakage currents.
Left Ventricular Lead Systems – BIOTRONIK CRT-Ds may be
implanted with any legally marketed, compatible LV lead.
Compatibility is defined as:
IS-1 pacing connector
Active or passive fixation technology
Insertion and withdrawal forces as specified by
ISO 5841-3 (IS-1)