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
en • English
3
Lead connectors
BIOTRONIK offers ICDs with headers for different standardized lead connections:
•
DF-1/IS-1 and DF-1/IS-1/IS4
•
DF4, DF4/IS-1 and DF4/IS-1/IS4
Note:
Suitable leads must comply with the norms:
•
A device's DF-1 connector port may only be used for connecting leads with a
DF-1 connector that conform to ISO 11318.
•
A device's IS-1 connector port may only be used for connecting leads with a
IS-1 connector that conform to ISO 5841-3.
•
A device's DF4 connector port may only be used for connecting leads with a
DF4 connector that conform to ISO 27186.
•
A device's IS4 connector port may only be used for connecting leads with a
IS4 connector that conform to ISO 27186.
Note:
The device and leads have to match.
•
Only DX type leads by BIOTRONIK may be connected to the device type VR DX with
DF-1/IS-1.
•
Only quadripolar leads may be connected to the device type HF QP with IS4.
•
When working with DX functionality, the device type HF (QP) with DF-1 may be
connected to DX type leads by BIOTRONIK.
DF-1/IS-1
The labeling on each device provides information pertaining to the connector port
assignment in the header.
DF-1/IS-1/IS4
The labeling on each device provides information pertaining to the connector port
assignment in the header.
VR VR DX DR HF
DF-1
RV
SVC
DF-1
IS-1
RV
DF-1
RV
SVC
DF-1
IS-1
RA
IS-1
RV
DF-1
RV
SVC
DF-1 IS-1
RA
IS-1
RV
DF-1
RV
SVC
DF-1
IS-1
RA
IS-1
RV
LV
IS-1
Connector
port
Lead
connector
Configuration Implantation site Device type
RA IS-1 Bipolar Atrium VR DX, DR, HF
RV IS-1 bipolar Right ventricle VR, VR DX, DR, HF
RV DF-1 Shock coil Right ventricle VR, VR DX, DR, HF
SVC DF-1 Shock coil Superior vena cava VR, VR DX, 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 IS-1 Bipolar Right ventricle HF QP
RV DF-1 Shock coil Right ventricle HF QP
SVC DF-1 Shock coil Superior vena cava HF QP
LV IS4 Unipolar, bipolar Left ventricle HF QP
IS4-LLLL
LV
IS-1
RA
IS-1
RV
DF-1
SVC
DF-1
RV
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