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
3
DF4/IS-1 lead connection
The device labeling provides information pertaining to possible lead connections
depending on the device type and pertaining to connection assignment:
DF4/IS4/IS-1 lead connection
The device labeling provides information pertaining to possible lead connections
depending on the device type and pertaining to connection assignment:
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 radio frequency (RF) telemetry in the programmer. BIOTRONIK calls this func-
tion SafeSync
®
.
Connector
port
Lead
connector
Configuration Implantation site Device type
RV DF-1 Shock coil Right ventricle VR, DX, DR, HF
SVC DF-1 Shock coil Superior vena
cava
VR, DX, DR, HF
RA IS-1 Bipolar Atrium DX, DR, HF
(R)V IS-1 Bipolar (Right) ventricle VR, DX, DR, HF
LV IS-1 Unipolar, bipolar Left ventricle HF
VR DR HF
Connector
port
Lead
connector
Configuration Implantation site Device type
RA IS-1 Bipolar Atrium DR, HF
LV IS-1 Unipolar, bipolar Left ventricle HF
RV, SVC DF4 Bipolar and shock Right ventricle VR, DR, HF
Note:
The device's DF4 connector port may only be used for connecting leads with a
DF4 connector that conform to ISO 27186.
DF4-LLHH
RV
DF4-LLHH
RV
IS-1
RA
DF4-LLHH
RV
IS-1
RA
IS-1
LV
HF QP
Connector
port
Lead
connector
Configuration Implantation site Device type
RA IS-1 Bipolar Atrium HF QP
LV IS4 Unipolar, bipolar Left ventricle HF QP
RV, SVC DF4 Bipolar and shock Right ventricle HF QP
Note:
The device's DF4/IS4 connector port may only be used for connecting leads with
a DF4/IS4 connector that conform to ISO 27186.
DF4-LLHH
RV
IS4-LLLL
RA
IS-1
LV