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
19 Implantation
Connecting the lead
connector to the device
Keeping distance between
leads
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 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 ven-
tricle to LV.
DF4/IS-1 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 ven-
tricle 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 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
safely seals the lead connector port.
!
!
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.