User Manual
Table Of Contents
- Cover
- 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 connector ports are clean
- Overview: Implanting
- Connecting the device
- Keeping distance between leads
- Applying the programming head
- Establishing RF telemetry
- Activating ICD therapy
- Precautionary Measures while Programming
- Performing standard tests and monitoring the patient
- Cancelling telemetry
- Avoiding critical parameter settings
- Avoiding risks in the case of exclusive LV pacing
- Monitoring the patient when setting asynchronous modes
- Complying with the morphology criteria
- Setting sensing
- Preventing device-induced complications
- Preventing conduction of atrial tachycardia
- Avoiding AV crosstalk
- Observing the shock impedance limit
- Preventing recurrence after therapy shock
- Phrenic nerve stimulation that cannot be terminated
- Note the reduced pulse amplitude due to a battery voltage drop
- Observe when inducing short-term cardiac arrest
- Checking the settings of the DX lead
- Checking for electrodes suitable for the shock path
- 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 suppression
- Timing: Ventricular pacing
- Timing: Ventricular multi pole pacing
- Timing: Refractory periods and blanking periods
- Timing: PMT protection
- Timing: Rate adaptation via accelerometer
- Timing: Rate adaptation via CLS
- Pacing: Pulse amplitude and pulse width
- Pacing: Atrial capture control
- Pacing: Ventricular capture control
- Lead configuration LV on IS-1 connection
- Lead configuration LV on IS4 connection
- MRI program
- Tachycardia
- Sensing
- Diagnostics
- Home Monitoring
- Bradycardia / CRT
- 5 Technical Data
14
Cancelling telemetry
Programmer interference or interrupted telemetry during performance of temporary
programs (follow-up tests) can result in inadequate pacing of the patient. This is the
case if the programmer can no longer be operated due to a program error or
a defective touch screen and therefore the temporary program cannot be terminated.
Under these circumstances, it is helpful to cancel telemetry, in which case the device
automatically switches to the permanent program.
•
In the case of telemetry with programming head: lift the PGH by at least 30 cm.
•
In the case of RF telemetry: switch off and reposition the programmer.
•
Turn off possible sources of interference.
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 exertion.
•
Check compatibility and effectiveness of parameter combinations after making
settings.
•
When setting atrial therapies after an AT or AF has been detected, note that no
ventricular tachyarrhythmia can be detected for the duration of atrial therapy
delivery.
Avoiding risks in the case of exclusive LV pacing
Lead dislodgement in the case of exclusive left ventricular pacing could pose the
following risks: loss of ventricular pacing and ATP therapy, induction of atrial arrhyth-
mias.
•
Consider sensing and pacing parameters with reference to loss of therapy.
•
Exclusive LV pacing is not recommended for patients who depend on the device.
•
Please note that capture control is not available.
•
In the case of follow-ups and threshold tests, take loss of synchronized ventricular
pacing into consideration.
•
Mode switching and post shock do not permit exclusive LV pacing. Please note the
effects when programming mode switching and the post shock parameters.
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.
Complying with the morphology criteria
To distinguish between ventricular and supraventricular tachyarrhythmia, QRS
complexes, among other aspects, are compared to each other. You can set
a MorphMatch threshold for the purpose of tachyarrhythmia discrimination, usually
a standard value. Settings that differ, that is to say, a higher or lower threshold to
discriminate the individual QRS complexes, may lead to a delayed/inhibited or unneces-
sary therapy.
•
Set deviations from the standard with particular caution.
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.
•
Prefer Wenckebach response and avoid 2:1 behavior.
•
Set all parameters so as to prevent constant changing between atrial and
ventricular-controlled modes.
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