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
Shock delivery with activated ICD
There is a risk of unintended shock delivery when handling an activated ICD.
•
Deactivate ICD therapy before touching the device during implantation, device
replacement and explantation.
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Preventing unintentional shock delivery
Avoiding damage to the header
Set screws and blind plugs (if applicable) must be tightened or loosened with care.
•
Loosen set screws with the supplied screwdriver. Use only BIOTRONIK screw-
drivers with torque control!
•
Do not forcibly pull out the blind plug!
•
If lead revision is necessary, re-order sterile screwdrivers from BIOTRONIK.
Short circuit due to open lead connector ports
Connector ports in the header which are open and thus not electrolyte-proof may
cause undesired current flows to the body and penetration of body fluid into the
device.
•
Close unused connector ports with blind plugs.
Preventing short circuits in the header
Ensure that connector ports are clean
In case of contamination during implantation:
•
Clean lead connectors with a sterile cloth.
•
Rinse connector port only with sterile water.
Overview: Implanting
Connecting the device
The lead connectors are connected to the ports in the header of the device:
W
WARNING
W
WARNING
1Prepare the vein.
2 Implant the leads, perform the measurements, and fixate the leads.
3 Form the device pocket.
4 Connect the lead connector to the device.
5 Insert the device.
6 Guide the fixation suture through the opening in the header and fixate the device
in the prepared device pocket.
7 Close the device pocket.
8 Check the device with standard tests.
1 Remove stylets and stylet guides.
2 Connect lead for defibrillation: DF-1/IS-1 or DF-1/IS4/IS-1
•
Connect the DF-1 connector for the right-ventricular shock coil to RV.
•
Connect the DF-1 connector for the supraventricular shock coil to SVC.
(Or connect a subcutaneous array to SVC).
Connect lead for defibrillation (and sensing/pacing): DF4/IS-1 or DF4/IS4/IS-1
•
Connect the DF4 connector to RV.
3 Connect lead for sensing/pacing: DF-1/IS-1 or DF-1/IS4/IS-1
•
Connect the bipolar IS-1 connector for the atrium to RA.
•
Connect the bipolar IS-1 connector for the right ventricle to RV.
•
Connect the unipolar or bipolar IS-1 connector for the left ventricle or the
quadripolar IS4 connector for the left ventricle to LV.
Connect lead for sensing/pacing: DF4/IS-1 or DF4/IS4/IS-1
•
Connect the bipolar IS-1 connector for the atrium to RA.
•
Connect the unipolar or bipolar IS-1 connector for the left ventricle or the
quadripolar IS4 connector for the left ventricle to LV.
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