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
28
Legend for the Label
Label on the package
The label icons symbolize the following:
Manufacturing date Use by
Temperature limit Order number
Serial number Product identification
number
Dangerous voltages! CE mark
Contents Follow the instructions for
use
Sterilized with ethylene oxide
Do not resterilize Single use only. Do not re-
use!
Do not use if packaging is
damaged
Non-sterile
Transmitter with non-ionizing radiation at
designated frequency
Label icon on devices
with ProMRI
®
MR conditional: Patients who have a system
with devices labeled with this symbol on the
packaging can be examined using an MRI
scan under precisely defined conditions.
STERILIZE
2
NON
STERILE
TP2
Compatibility with telemetry protocol, version 2 of
BIOTRONIK Home Monitoring
Example
Device: NBG code and compatible leads
Example
Factory settings for therapy: OFF
Screwdriver
Examples of DF-1/IS-1 or DF4/IS-1 header
Examples of DF4/IS4/IS-1 header
Bipolar IS-1 connector
Unipolar IS-1 connector
Unipolar DF-1 connector
DF4/IS4 connector