Avoiding risks in the case of exclusive LV pacing
Lead dislodgement in the case of exclusive left ventricular pacing could pose the
following risks: loss of ventricular pacing and ATP therapy, induction of atrial arrhyth-
mias.
• Consider sensing and pacing parameters with reference to loss of therapy.
• Exclusive LV pacing is not recommended for patients who depend on the device.
• Please note that active capture control is not available.
• In the case of follow-ups and threshold tests, take loss of synchronized ventricular
pacing into consideration.
• Mode switching and post-shock do not allow for exclusive LV pacing. Please note
the effects when programming mode switching and the post shock parameters.
Recognizing lead failure
Automatic impedance measurement is always switched on.
• Impedance values that indicate technical failure of a lead are documented in the
event list.
Considering power consumption and service time
RF telemetry requires somewhat more power: Consumption during implantation corre-
sponds to approximately 10 days of service time and consumption during a 20-minute
follow-up corresponds to approximately 3 days.
• Do not establish unnecessary RF telemetry.
• After 5 minutes without input, SafeSync switches to the economy mode.
• Check the battery capacity of the device at regular intervals.
Magnet Response
Application of the programming head when ICD therapy is set
If a connected programming head is applied and is communicating with the
programmer and ICD therapy is permanently set, detection and therapy remain intact
except during the diagnostic tests. If ICD therapy is not set as permanent, no therapy is
delivered when the programming head is applied.
Programming head application
When the programming head is applied, time remains for device interrogation and for
manual activation or deactivation of the therapy before the device switches back to the
previously set permanent therapy mode. The same applies to programming head appli-
cation to establish RF telemetry contact.
en • English
Application of a permanent magnet
Applying a permanent magnet interrupts detection and therapy of tachycardia events.
After 8 hours of this type of deactivation, the device automatically reactivates the
therapy functions to prevent accidental permanent deactivation.
• If detection interruptions of longer than 8 hours are required, the magnet has to be
briefly removed from the device. The 8 hour countdown restarts when the magnet
is applied again.
• Use BIOTRONIK magnets: type M-50 permanent magnets.
Follow-up
Follow-up intervals
Follow-ups must be performed at regular, agreed intervals.
• The first follow-up should be carried out by the physician using the programmer
(in-office follow-up) approximately 3 months after implantation following the lead
ingrowth phase.
• The next in-office follow-up should be carried out once a year and no later than
12 months after the last in-office follow-up.
Follow-up with BIOTRONIK Home Monitoring
Monitoring using the Home Monitoring function does not serve to replace regular in-
office appointments with the physician required for other medical reasons. Follow-up
supported by Home Monitoring can be used to functionally replace in-office follow-up
under the following conditions:
• The patient was informed that the physician must be contacted despite use of the
Home Monitoring function if symptoms worsen or if new symptoms arise.
• Device messages are transmitted regularly.
• The physician decides whether the data transmitted via Home Monitoring with
regard to the patient's clinical condition as well as the technical state of the device
system are sufficient. If not, an in-office follow-up needs to be carried out.
Possible early detection due to information gained via Home Monitoring may necessi-
tate an additional in-office follow-up. For example, the data may indicate at an early
stage lead problems or a foreseeable end of service time (ERI). Furthermore, the data
could provide indications of previously unrecognized arrhythmias or modification of the
therapy by reprogramming the device.
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