User Manual
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
- Checking for electrodes suitable for the 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 supression
- Timing: Ventricular pacing
- Timing: Refractory periods and blanking periods
- Timing: PMT protection
- Timing: Rate adaptation via accelerometer
- Timing CLS-Modes: Closed Loop Stimulation
- Pacing: Pulse amplitude and pulse width
- Pacing: Ventricular capture control
- Pacing: atrial capture control
- LV lead configuration with IS-1
- LV lead configuration with IS4
- MRI program
- Tachycardia
- Sensing
- Diagnostics
- Home Monitoring
- Bradycardia / CRT
- 5 Technical Data
15
Avoiding critical parameter settings
No modes and parameter combinations that pose a risk to the patient should be set.
•
Prior to setting rate adaptation, determine the patient's capacity for strain.
•
Check compatibility and effectiveness of parameter combinations after making
settings.
Checking for electrodes suitable for the shock path
Three different shock paths can be set. Two of these form an electrical path to the
housing of the implanted device.
•
For the RV -> SVC shock path, a second shock coil must be available
(dual shock coil).
Monitoring the patient when setting asynchronous modes
The asynchronous modes V00 and D00 can only be set if tachyarrhythmia sensing is
deactivated. This would leave the patient without sensing and therefore without ICD
therapy.
•
Continually monitor the patient.
•
Keep an external defibrillator ready.
Setting sensing
Manually set parameters can be unsafe. For example, unsuitable far-field protection
may impede sensing of intrinsic pulses.
•
Note automatic sensitivity control.
Preventing device-induced complications
BIOTRONIK devices feature several functions to prevent device-induced complications
to the greatest extent possible:
•
Measure the retrograde conduction time.
•
Set PMT protection.
•
Set the VA criterion.
Preventing conduction of atrial tachycardia
BIOTRONIK devices feature several functions to prevent conduction of atrial tachy-
cardia to the ventricle(s):
•
Set mode switching for indicated patients.
•
Set the upper rate and the refractory periods to prevent abrupt ventricular rate
switching.
•
Give preference to Wenckebach response and avoid 2:1 behavior.
•
Set all parameters so as to prevent constant changing between atrial and ventric-
ular-controlled modes.
Observing the shock impedance limit
The implanted device could be damaged if the shock impedance is too low.
•
The shock impedance must be > 25 Ω.
Preventing recurrence after therapy shock
After a therapy shock, pacing can be performed with a post-shock program if there is
no intrinsic rhythm.
•
The following post-shock program parameters can be adjusted: post-shock dura-
tion, basic rate, rate hysteresis, ventricular pacing, LV-T-wave protection, trig-
gering, AV delay (fixed, not dynamic).
•
The default settings for the post-shock program are as follows:
A and RV: 7.5 V, 1.5 ms
LV: settings from the permanent program
Phrenic nerve stimulation that cannot be terminated
In rare cases, chronic phrenic nerve stimulation cannot be terminated by reprogram-
ming the available left ventricular pacing configuration or using other measures.
•
Set a right ventricular mode both in the permanent program as well as the ATP, in
the post-shock program and for mode switching if need be.
Permanent program Post-shock program
DDD, DDD-CLS
DDI, AAI, DDD-ADI
DDI
VDD, VDI VDI
VVI, VVI-CLS and OFF VVI