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
4
DF4/IS-1
The labeling on each device provides information pertaining to the connector port
assignment in the header.
DF4/IS-1/IS4
The labeling on each device provides information pertaining to the connector port
assignment in the header.
Leads
BIOTRONIK leads are sheathed with biocompatible silicone. They can be flexibly
maneuvered, are stable long-term, and are equipped for active or passive fixation. They
are implanted using a lead introducer set. Some leads are coated with polyurethane
which is known to increase the sliding properties for the lead. Leads with steroids
reduce inflammatory processes. The fractal design of the electrodes provides for low
pacing thresholds. BIOTRONIK provides adapters to connect already implanted leads to
new devices.
Telemetry
Telemetric communication between the device and the programmer can be carried out
following initialization either by applying the programming head (PGH) to the device or
by using wireless radio frequency (RF) telemetry in the programmer. BIOTRONIK calls
this function SafeSync.
Programmer
Implantation and follow-up are performed with BIOTRONIK's portable programmer:
Software PSW as of version 1505.
There are programmers with integrated or external SafeSync Module for RF telemetry.
Leadless ECG, IEGM, markers and functions are displayed simultaneously on the color
display.
The programmer allows you to determine the thresholds and to perform all tests
during an in-office follow-up; in addition, you can change the permanent program and
send it to the implanted device.
In addition to this, the programmer is used to set mode and parameter combinations,
as well as for interrogation and saving of data from the device.
VR DR HF
Connector
port
Lead
connector
Configuration Implantation site Device type
RA IS-1 Bipolar Atrium DR, HF
RV DF4 Bipolar and shock coil Right ventricle VR, DR, HF
LV IS-1 Unipolar, bipolar Left ventricle HF
HF QP
Connector
port
Lead
connector
Configuration Implantation site Device type
RA IS-1 Bipolar Atrium HF QP
RV DF4 Bipolar and shock coil Right ventricle HF QP
LV IS4 Unipolar, bipolar Left ventricle HF QP
DF4-LLHH
RV
DF4-LLHH
RV
RA
IS-1
DF4-LLHH
RV
RA
IS-1
LV
IS-1
DF4-LLHH
RV
LV
IS4-LLLL IS-1
RA
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