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
13
Connecting the lead connector to the device
Keeping distance between leads
Implanting
1 Disconnect stylets and stylet guides.
2 DF-1/IS-1 connection:
•
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.
DF4/IS-1 or DF4/IS4 connection:
•
Connect the DF4 connector to RV
3 DF-1/IS-1 connection:
•
Connect the bipolar IS-1 lead connector for the atrium to RA.
•
Connect the IS-1 lead connector for the right ventricle to RV.
•
Connect the unipolar or the bipolar IS-1 lead connector for the left ventricle
to LV.
DF4/IS-1 or DF4/IS4 connection:
•
Connect the bipolar IS-1 lead connector for the atrium to RA.
•
Connect the unipolar or the bipolar IS-1 lead connector for the left ventricle
to LV.
•
Or: Connect the quadripolar IS4 lead connector for the left ventricle to LV.
4 Push the lead connector into the header without twisting or bending the
connector or conductor until the connector tip (on the DF-1 connector) or the
insertion indicator (on the DF4 /IS4 connector) becomes visible behind the set
screw block. This indicator can vary depending on the manufacturer of the lead
used.
5 If you cannot easily plug the lead connector into the connection:
•
Use only sterile water as lubricant.
6 If the lead connector cannot be inserted completely, the set screw may be
protruding into the drill hole of the set screw block.
•
Use the screwdriver to perpendicularly pierce through the slitted point in
the center of the silicone plug until it reaches the set screw.
•
Carefully loosen the set screw without completely unscrewing it, so that it
does not become tilted upon retightening.
7 Turn the set screw clockwise until torque control starts (you will hear a clicking
sound).
8 Carefully withdraw the screwdriver without retracting the set screw.
•
In case of IS-1 connections with two set screws, tighten both screws!
•
When the screwdriver is withdrawn, the silicone plug automatically seals
the lead connector port safely.
W
WARNING
Inadequate therapy
When leads are not spaced sufficiently apart or are positioned inappropriately, this
can lead to far-field sensing or insufficient defibrillation.
•
The distance between 2 shock coils must be greater than 6 cm.
•
Tip and ring electrodes must not have contact with each other.
1 Prepare 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.