User Manual
Table Of Contents
- Cover
- 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
- Preventing leakage currents
- Preventing unintentional shock delivery
- Avoiding damage to the header
- Preventing short circuits in the header
- Ensure that connections are clean
- Connecting the lead connector to the device
- Keeping distance between leads
- Implanting
- Applying the programming head
- Establishing telemetry contact
- Activating ICD therapy
- Precautionary Measures while Programming
- Performing standard tests and monitoring the patient
- Cancelling telemetry
- Avoiding critical parameter settings
- Check for leads suitable for shock path
- Monitoring the patient when setting asynchronous modes
- Setting sensing
- Preventing device-induced complications
- Preventing conduction of atrial tachycardia
- Observing the shock impedance limit
- Preventing recurrence after therapy shock
- Phrenic nerve stimulation that cannot be terminated
- Avoiding risks in the case of exclusive LV pacing
- Recognizing lead failure
- Considering power consumption and service time
- Magnet Response
- Follow-up
- Patient Information
- Replacement Indications
- Explantation and Device Replacement
- Implantation Procedure
- 4 Parameters
- Bradycardia / CRT
- General ICD therapy
- Timing: Basic rate day/ night and rate hystereses
- Timing: AV delay
- Timing: Post-shock pacing
- Timing: Upper rate
- Timing: Mode switching
- Timing: Ventricular pacing
- Timing: Refractory periods and blanking periods
- Timing: PMT protection
- Timing: Rate adaptation via accelerometer
- Pacing: Pulse amplitude and pulse width
- Pacing: Ventricular capture control
- Pacing: atrial capture control
- LV lead configuration
- Tachycardia
- Sensing
- Diagnostics
- Home Monitoring
- Bradycardia / CRT
- 5 Technical Data
14 General Safety Instructions
Possible Complications
General information on
medical complications
Complications for patients and device systems generally recognized among prac-
titioners 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 impossible to guarantee the efficacy of antitachycardia therapy, even if the
programs have proven successful during tests or subsequent electrophysio-
logical examinations. In rare cases the set parameters may become ineffective.
It is possible for therapies to induce or accelerate tachycardia and cause sus-
tained ventricular flutter or fibrillation.
Skeletal myopotentials Bipolar sensing and control of sensitivity are adapted by the device to the rate
spectrum of intrinsic events so that skeletal myopotentials are usually not
recorded. Skeletal myopotentials can nonetheless be classified as intrinsic events
especially at very high sensing sensitivity and, depending on the interference, may
cause inhibition or antiarrhythmia therapy.
In the case of undesired myopotentials, the device switches to asynchronous
pacing if the interference rate is exceeded.
Possible technical failures Technical failure of a device system cannot be entirely ruled out. Possible causes
can include the following:
• Lead dislodgement, lead fracture
• Insulation defects
• Device component failures
• Battery depletion
• Interrupted telemetry
Electromagnetic interfer-
ence (EMI)
Any device can be sensitive to interference if external signals are sensed as
intrinsic rhythm or if measurements prevent rate adaptation.
• 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, if any, in patients.
• Depending on the pacing mode and the type of interference, sources of inter-
ference may lead to pulse inhibition or triggering, an increase in the sensor-
dependent pacing rate or asynchronous pacing.
• Under unfavorable conditions, for example during therapeutic or diagnostic
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 case of electromagnetic interference, the device switches to asynchronous
pacing for as long as the interference rate is exceeded.
Static magnetic fields The reed switch in the device closes starting at a field strength of 1.8 mT. The reed
switch opens if the magnetic field falls below 1 mT.