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
28 Implantation
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.
• Use state-of-the-art techniques to remove the device and, if necessary, the
leads.
• 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.
Cremation Devices should not be cremated.
• Explant the device before the cremation of a deceased patient.
Disposal BIOTRONIK takes back used products for the purpose of environmentally safe dis-
posal.
• Clean the explant with an at least 1% sodium hypochlorite solution.
• Rinse off with water.
Note: Normal oxidation processes may cause ICD housing discolorations. This is
neither a device defect nor does it influence device functionality.