User Manual
Table Of Contents
- Edora 8
- Table of Contents
- 1 Product Description
- 2 General Safety Instructions
- 3 Implantation
- Implantation Procedure
- Having parts ready
- Keeping an external defibrillator ready
- Unpacking the device
- Checking parts
- Implantation site
- Overview: Implanting
- Avoid damage to the header
- Preventing short circuits in the header
- Keeping distance between leads
- Connecting the lead connector to the device
- Applying the programming head
- Establishing wandless telemetry
- Auto-initialization
- Behavior during auto- initialization
- Precautionary Measures while Programming
- Checking the device system
- Performing standard tests and monitoring the patient
- Do not interrupt wandless telemetry during a treatment
- Cancelling telemetry
- Avoiding critical parameter settings
- Manually setting lead polarity
- Setting sensing
- Setting the sensitivity
- Preventing device-induced complications
- Preventing conduction of atrial tachycardia
- Phrenic nerve stimulation that cannot be terminated
- Avoiding risks in the case of exclusive left ventricular pacing
- If an ICD is implanted at the same time, do not permit unipolar pacing
- Recognizing lead failure
- Consider power consumption and service time
- Magnet Response
- Follow-up
- Patient Information
- Replacement Indications
- Explantation and Device Replacement
- Implantation Procedure
- 4 Parameters
- 5 Technical Data
19
Implantation
Precautionary Measures while Programming
Preventing device-induced
complications
BIOTRONIK devices are equipped with several functions to prevent device-induced
complications to the greatest extent possible:
• Measure the retrograde conduction time.
• If the function is not yet automatically set: activate PMT protection.
• Set the VA criterion: The aim is to set a VA criterion that is longer than the
longest measured retrograde conduction time.
Preventing conduction of atrial
tachycardia
BIOTRONIK devices are equipped with several functions to prevent conduction of
atrial tachycardia to the ventricle(s):
•Set Mode Switching for indicated patients.
• Set the upper rate and the refractory periods to prevent abrupt ventricular rate
switching.
• Prefer Wenckebach response and avoid 2:1 behavior.
• Set all parameters so as to prevent constant changing between atrial and
ventricular-controlled modes.
Phrenic nerve stimulation that
cannot be terminated
With LV pacing, chronic phrenic nerve stimulation can in rare cases not be
terminated by reprogramming the available left ventricular pacing configurations
or by other measures.
• Possibly set a right ventricular mode both in the permanent program and for
Mode
Switching.
Avoiding risks in the case of
exclusive left ventricular
pacing
Lead dislodgement in the case of exclusive left ventricular pacing could pose the
following risks: loss of ventricular pacing as well as induction of atrial arrhythmia.
• Consider sensing and pacing parameters with reference to loss of therapy.
• Exclusive left ventricular pacing is not recommended for patients who depend
on the device.
• Take possible interruption of automatic Active Capture Control into
consideration.
• In the case of follow-ups and threshold tests, take loss of synchronized
ventricular pacing into consideration.
• Mode Switching does not allow exclusive left ventricular pacing; consider the
consequences when setting Mode Switching parameters.
If an ICD is implanted at the
same time, do not permit
unipolar pacing
If an ICD is implanted in addition to a pacemaker and a lead failure occurs, it is
possible to switch to unipolar pacing after resetting the pacemaker or using the
automatic lead check. As a result, the ICD could falsely inhibit or trigger
tachyarrhythmiatherapy activity.
• Unipolar leads are not permitted in this configuration.
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.