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
18
•
VT and VF detection and all therapies are deactivated!
•
The antibradycardia function remains active in the VVI mode:
—
Ventricular pacing: RV; basic rate 50 bpm; without special pacemaker functions
such as hysteresis, etc.
—
Pulse amplitude of 6 V; pulse width of 1.5 ms
—
Cycle duration for BIOTRONIK Home Monitoring: 90 days
Explantation and Device Replacement
Explantation
•
Interrogate the device status.
•
Deactivate VT and VF therapies prior to explantation.
•
Remove the leads from the header. Do not simply cut them loose.
•
Use state-of-the-art techniques to remove the device and, if necessary, the leads.
Note:
Normal oxidation processes may cause ICD housing discolorations. This is
neither a device defect nor does it influence device functionality.
•
Explants are biologically contaminated and must be disposed of safely due to risk of
infection.
Device replacement
If, upon replacing the device, already implanted leads are no longer used but left in the
patient, then an additional uncontrolled current path to the heart can result.
•
Deactivate VT and VF therapies prior to device replacement.
•
Cap unused lead connectors and plug unused connector ports.
Basic principles:
•
The device must not be resterilized and reused.
Cremation
Devices must not be cremated.
•
Explant the device before the cremation of a deceased patient.
Disposal
BIOTRONIK takes back used products for the purpose of environmentally safe disposal.
•
Clean the explant with a solution of at least 1% sodium hypochlorite.
•
Rinse off with water.
•
Fill out explantation form and send to BIOTRONIK together with the cleaned device.
4 Parameters
Bradycardia / CRT
General ICD therapy
Timing: Basic rate day/night and rate hystereses
Parameter Range of values Standard VR DX DR HF
ICD therapy OFF; ON ON xxxx
Programs Display standard program;
Display safe program;
Display first interrogated
program; Individual 1, 2, 3;
ProgramConsult
— xxxx
Parameter Range of values Standard VR DX DR HF
Basic rate 30 ... (5) ... 100 ... (10)
... 160 bpm
40 bpm x x
60 bpm x x
Night rate OFF; 30 ... (5) ... 100 bpm OFF xxxx
Night begins 00:00 ... (00:01)
... 23:59 hh:mm
22:00
hh:mm
xxxx
Night ends 06:00
hh:mm
Rate hysteresis OFF; -5 ... (-5) ... -25 ...
(-20) ... -65 bpm
OFF xxxx
Scan/repetitive OFF; ON ON xxxx
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