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
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.
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Keeping distance between leads
Applying the programming head
The programming head (PGH) features a diagram of the device. This is used to assist in
positioning the head to ensure proper telemetry.
•
Make sure the PGH is positioned correctly.
Establishing RF telemetry
The programmer (or the SafeSync Module) can be no more than 3 m from the device;
ideally there should be no hindrances between the patient and the programmer.
•
Switch on RF telemetry on the programmer.
•
Apply the programming head for about 2 s until successful initialization is displayed
on the programmer:
The SafeSync symbol is displayed in the navigator and the signal
strength is displayed in the status line.
•
Remove the programming head.
Activating ICD therapy
•
Load the software that is suitable for the device type in the programmer.
•
Activate ICD therapy.
•
Shipment mode is permanently deactivated once the leads have been connected
and initial measurement of the pacing impedance has been performed success-
fully. The device data are saved.
•
Take precautionary measures while programming.
•
If the device induces tachycardia while programming ATPs or does not deliver
adequate therapy in the DFT test: use emergency shock or an external defibrillator.
Precautionary Measures while Programming
Performing standard tests and monitoring the patient
Critical conditions can occur for the patient even during standard tests due to inade-
quate parameter settings or interrupted telemetry.
•
Ensure sufficient patient care even during tests.
•
After the threshold test, check to determine whether the threshold is clinically and
technically justifiable.
•
Continuously monitor the ECG and the patient's condition.
•
Cancel testing if necessary.
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 and the 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 2 set screws, tighten both screws!
•
When you withdraw the screwdriver, the silicone plug automatically seals
the access to the screw head safely.
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WARNING
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