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
12
General Safety Instructions
Possible Complications
Possible Complications
General information on
medical complications
Complications for patients and device systems generally recognized among
practitioners also apply to BIOTRONIK devices.
• Normal complications may include fluid accumulation within the device pocket,
infections, or tissue reactions. Primary sources of complication information
include current scientific and technological knowledge.
• It is not possible to guarantee the efficacy of antiarrythmia therapy, even if the
programs have proven successful during tests or subsequent
electrophysiological examinations. In rare cases the set parameters can
become ineffective. In particular it is inevitable that tachyarrhythmias may be
induced.
Skeletal myopotentials
Bipolar sensing and control of sensitivity are adapted by the device to the rate range
of intrinsic events so that skeletal myopotentials are usually not sensed. Skeletal
myopotentials can nonetheless be classified as intrinsic events especially with a
unipolar configuration and/or very high sensitivity and, depending on the
interference, may cause inhibition or antiarrhythmia therapy.
Nerve and muscle stimulation
A device system consisting of a unipolar lead and an uncoated device may result in
undesirable pacing of the diaphragm in the case of an initial or permanent high
setting of the pulse amplitude.
Possible technical failures
Technical failure of a device system cannot be entirely ruled out. Possible causes
may include the following:
• Lead dislodgement
• Lead fracture
• Insulation defects
• Device component failures
• Battery depletion
Electromagnetic interference
(EMI)
Any device can be sensitive to interference, for example, when external signals are
sensed as intrinsic rhythm.
• BIOTRONIK devices have been designed so that their susceptibility to EMI is
minimal.
• Due to the intensity and variety of EMI, there is no guarantee for safety. It is
generally assumed that EMI produces only minor symptoms in patients - if any.
• Depending on the pacing mode and the type of interference, sources of
interference may lead to pulse inhibition or triggering, an increase in the
sensor-dependent pacing rate or asynchronous pacing.
• Under unfavorable conditions, for example during diagnostic or therapeutic
procedures, interference sources may induce such a high level of energy into
the pacing system that the cardiac tissue surrounding the lead tip is damaged.
Device behavior in case of EMI
In the case of electromagnetic interference or undesired myopotentials, the device
paces asynchronously for the duration of the time that the interference rate is
exceeded.
Static magnetic fields
The pacemaker switches to magnet response from a field strength > 1.0 mT.