BIOTRONIK Lumax 640 Gebrauchsanweisung Seite 14

Possible sources of interference
Electromagnetic interference should be avoided in daily activities. Sources of
interference should not be brought into close proximity with the device.
• Draw the patient's attention to special household appliances, safety locks, anti-
theft devices, strong electromagnetic fields, cell phones, and transmitters among
other things.
• Request patients to do the following:
— Use cell phones on the opposite side of their body from the device.
— Keep the cell phone at least 15 cm away from the device both during use and
when stowing.
Replacement Indications
Possible battery levels
• BOS: Beginning of Service: > 70% charge
• MOL 1: Middle of Life : 70% to 40% residual charge
• MOL 2: Middle of Life : < 40% residual charge
• ERI: Elective Replacement Indication, (i.e. RRT: Recommended Replacement Time)
• EOS: End of Service
Elective Replacement Indication (ERI)
Elective Replacement Indication can be detected by Home Monitoring.
W CAUTION
Temporally limited therapy
If ERI occurs shortly after follow-up and is only detected during the subsequent
follow-up, then the remaining service time can be much less than 3 months.
• Replace device soon.
• The device can monitor the heart rhythm for at least 3 more months.
• At least 6 maximum energy shocks can be delivered until EOS occurs.
• The selected parameters in the device program do not change.
en • English
EOS replacement indication
End of Service can be detected by Home Monitoring.
W WARNING
Patient at risk of death
If EOS replacement indication occurs before replacement of the device, then the
patient is without therapy.
• Replace device immediately.
• Monitor patient constantly until immediate replacement of the device!
• VT and VF detection and all therapies are deactivated!
• The antibradycardia function remains active in the VVI mode:
— Ventricular pacing: RV; basic rate 50 bpm; without special pacemaker functions
such as hysteresis, etc.
— Pulse amplitude of 6 V; pulse width of 1.5 ms
— Time of transmission for Home Monitoring: 90 days
Explantation and Device Replacement
Explantation
• Interrogate the device status.
• Deactivate VT and VF therapies prior to explantation.
• Remove the leads from the header. Do not simply cut them loose.
• Remove the device and, if necessary, the leads using state-of-the-art technology.
Note: Normal oxidation processes may cause ICD housing discolorations. This is
neither a device defect nor does it influence device functionality.
• Explants are biologically contaminated and must be disposed of safely due to risk of
infection.
Device replacement
If, upon replacing the device, already implanted leads are no longer used but left in the
patient, then an additional uncontrolled current path to the heart can result.
• Deactivate VT and VF therapies prior to device replacement.
• Insulate connections that are not used.
Basic principles:
• The device must not be resterilized and reused.
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