BIOTRONIK Lumax DR ICD Series, Technical Manual, Page: 142 / 176

Lumax Technical Manual 13
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Device Packaging - Do not use the device if the device’s
packaging is wet, punctured, opened or damaged because
the integrity of the sterile packaging may be compromised.
Return the device to BIOTRONIK.
4.4 Pocket Preparation
Using standard surgical technique, create a pocket for the device
either in the patient’s pectoral or abdominal region dependent on
patient anatomy. The device may be implanted either below the
subcutaneous tissue or in the muscle tissue. The ICD/CRT-D
should be implanted with the etched side facing up. The leads
should be tunneled or surgically brought into the device pocket. If
lead tunneling is performed, re-evaluation of the baseline lead
signals, after tunneling is recommended.
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The ICD/CRT-D system should have detection and therapy
disabled prior to performing medical procedures. In addition,
the ICD/CRT-D should be checked after the procedures to
assure proper programming:
Electrocautery - Electrosurgical cautery could induce
ventricular arrhythmias and/or fibrillation, or may cause
device malfunction or damage. If use of electrocautery is
necessary, the current path and ground plate should be kept
as far away from the pulse generator and leads as possible
(at least 6 inches (15 cm)).
4.5 Lead to Device Connection
The Lumax ICD/CRT-Ds have been designed and are
recommended for use with a defibrillation lead systems having
one IS-1 connector for ventricular sensing and pacing and up to
two DF-1 connectors for delivery of shock therapy. A separate
bipolar atrial lead with IS-1 connector is required for atrial sensing
and pacing functions and the CS lead for biventricular pacing
(LV). Figure 11 depicts the configuration of the header ports on
the Lumax HF CRT-Ds, where HV1 and HV2 are for DF-1
connectors, and A P/S and V P/S are for IS-1 connectors.