System Description; Intended Medical Use - BIOTRONIK Lumax 540 Manuel Technique

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System Description

Intended Medical Use

Lumax is the name of a family of implantable cardioverter-defibrillators (ICDs).
Primary objective of the therapy is to prevent sudden cardiac death. The aim is to auto-
matically detect and terminate cardiac arrest caused by ventricular tachyarrhythmia.
All major therapeutical approaches from the field of cardiology and electrophysiology
are contained within the Lumax family.
Furthermore, the device is capable of treating bradycardia arrhythmias and congestive
heart failure with multisite ventricular pacing – known as cardiac resynchronization
therapy.
The integrated Home Monitoring component can provide information about occurring
rythm disturbances and delivered therapies close to real time as well as by IEGM
®
Online HD . Furthermore, statistical data about the patient's condition as well as infor-
mation about the integrity status of the device itself are sent.
The implantation of an ICD is a symptomatic therapy with the following objectives:
• Termination of spontaneous ventricular fibrillation (VF) through shock delivery
• Termination of spontaneous ventricular tachycardia (VT) through antitachycardia
pacing (ATP); in case of ineffective ATP or hemodynamically not tolerated VT, with
shock delivery
• Cardiac resynchronization through multisite ventricular pacing (triple-chamber
device)
• Compensation of bradycardia through ventricular (single-chamber device) or
AV sequential pacing (dual- and triple-chamber device)
Required expertise
In addition to having basic medical knowledge, the user must be thoroughly familiar
with the operation of a device system. Only qualified medical specialists having the spe-
cial knowledge required for the proper use of devices are permitted to use them. If
users do not possess this knowledge, they must be trained accordingly.
All manuals and user guides at all-guides.com
ICD System
Lumax
The Lumax ICD system consists of the following:
• Single-, dual- or triple-chamber device with connections for bipolar sensing and
pacing as well as connections for shock delivery
• ICD leads:
— One bipolar ICD lead with one or two shock coils for the ventricle (single-cham-
— One bipolar lead for the atrium and one bipolar ICD lead for the ventricle
— One uni- or bipolar CS lead (coronary sinus lead for the triple-chamber device)
• Programmer with current device program
Note: A tripolar or quadrupolar RV lead has bipolar electrodes as well as 1 or 2 shock
coils.
Device
The device's housing is made of biocompatible titanium, welded from outside and thus
hermetically sealed. It serves as a potential antipole during shock delivery. The ellip-
soid shape facilitates implantation in the pectoral muscle area.
The labeling provides information about the device type and the arrangement of the
connections.
Lumax family
The following types with Home Monitoring are available (some device types are not
available in all countries):
Device
Single-chamber
Dual-chamber
Triple-chamber
NBD and NBG codes
VVE is the NBD code for the antitachycardia mode of the single-chamber, dual-cham-
ber and triple-chamber devices:
2
ber device)
respectively with one or two shock coils (dual-chamber or triple-chamber
device)
High energy type: max. 40 J
Lumax 540 VR-T
Lumax 540 VR-T DX
Lumax 540 DR-T
Lumax 540 HF-T