Cautionary Notes - BIOTRONIK Lumax 540 Manuel Technique

387158--G_GA_Lumax540_mul.book Page 10 Friday, February 1, 2013 5:38 PM
Action on ERI
Proceed as follows:
1 Replace device soon.
EOS
• End of Service can be detected by Home Monitoring.
• VT and VF detection and all therapies are deactivated.
• The antibradycardia function remains active in the VVI mode:
— Basic rate 50 ppm
— Without special pacemaker functions, such as hysteresis, etc.
— Amplitude of 6 V
— Pulse width of 1.5 ms
W WARNING
EOS before explantation
If EOS occurs before replacement of the device, the patient is without antiarrhythmic
therapy and thus at risk of a life threatening condition!
Action on EOS
Proceed as follows:
1 Replace device immediately.
2 Monitor patient constantly until immediate replacement of the device!
Explantation and Disposal
Note: Before the cremation of a deceased patient, the device must be explanted.
W WARNING
Unintentional shock delivery
A shock could be delivered when handling an activated ICD. Devices may not be
explanted when detection is activated.
• Turn off the detection function before explantation.
• Do not simply cut the ICD leads.
All manuals and user guides at all-guides.com
Explanting the ICD
Proceed as follows:
Note: Normal oxidation processes may cause ICD housing discolorations. This is
neither a device defect nor does it influence device functionality.
Disposing of the ICD
Proceed as follows:
Medical Complications
General information on possible complications
It is impossible to guarantee the efficacy of antitachycardia or fibrillation therapy, even
if these therapies have proved successful during intraoperative tests or subsequent
electrophysiological tests. In rare circumstances, the set therapies may prove ineffec-
tive or, in unfavorable conditions, even life-threatening. It is possible for therapies to
induce or accelerate tachycardia and cause sustained ventricular flutter or fibrillation.
Known possible complications:
The following are some of the known medical complications related to pacemaker
therapy and ICD therapy:
• Formation of necrotic tissue
• Vascular damage
• Thrombosis
10
1 Interrogate the device status.
2 Deactivate VT and VF therapies.
3 Disconnect the leads from the header.
4 Remove the device and leads using state-of-the-art technology.
5 Dispose of the device in an environmentally safe manner.
6 Fill out explantation form and send to BIOTRONIK.
1 Clean the explant with an at least 1% sodium-hyperchlorine solution.
2 Rinse off with water.
3 Send to BIOTRONIK for disposal in an environmentally safe manner.

Cautionary Notes