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
7
Package contents
The storage package includes the following:
•
Sterile packaging with device
•
Serial number label
•
Patient ID card
•
Warranty booklet
Note:
Technical manuals are available either printed in the storage package or digitally
in the internet.
The sterile container includes the following:
•
Device, blind plug DF-1 (if applicable) and blind plug IS-1 for device type HF
•
Screwdriver
Therapeutic and Diagnostic Functions
Diagnostic functions
•
Data from implantation and the most recent interrogations and follow-ups are
recorded as well as arrhythmia episodes; they are stored together with other data
to assess patients and the state of the device at any time.
•
To check the lead for proper functioning, an automatic impedance measurement
using subthreshold pacing pulses is performed in the device.
•
Leadless ECG function: For all device types, far-field derivation can be measured
without external leads between the right ventricular shock coil and housing, which,
depending on the implantation site, corresponds to ECG derivation II or III
(Einthoven).
•
Once a telemetry connection has been established during a test procedure in an in-
office follow-up, the leadless ECG and the IEGM are displayed with markers.
Antitachycardia pacing
•
The ICD can treat ventricular tachycardia with antitachycardia pacing (ATP); ATP can
also be delivered in the VF zone (ATP One Shot) when the stability criterion indicating
that this will be effective before shock delivery (monomorphic rapid VTs) is met.
•
Arial tachycardia can be treated with antitachycardia pacing (atrial ATP) at stable
heart rhythms and with high frequency bursts (HF burst) at instabil heart rhythms.
•
Depending on the device type, the device program contains not only the ICD func-
tions but also all pacemaker functions for 1, 2, or 3 chambers. The heart rhythm is
continuously monitored; each arrhythmia is classified according to the heart rate
and the adjustable detection criteria. Depending on the preset values, antibrady-
cardia as well as antitachycardia therapy is inhibited or delivered.
Cardioversion, defibrillation
•
The ICD can treat ventricular tachyarrhythmia with cardioversion and/or defibrilla-
tion. Shock polarity and energy can be programmed individually. Shock energies
between 2.0 and 45 J are possible. Before delivery of the shock, the ICD can be set
to only deliver a shock when ongoing tachyarrhythmia is confirmed; during this
time period the device can identify spontaneous conversion of the tachyarrhythmia
and cancel the charging process if necessary.
•
The shock paths can be set between the different shock coils (SVC/RV) and/or the
housing.