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
9
2 General Safety Instructions
Operating Conditions
Technical manuals
Folgende Gebrauchsanweisungen informieren über die Anwendung von Implantatsys-
temen:
— Technical manual for the device
— Technical manual for the HMSC
— Technical manuals for the programmer and the SafeSync Module
— Technical manuals for the user interface
— Technical manuals for cables, adapters and accessories
•
Technical manuals are available either printed in the storage package or digitally in
the internet: https://manuals.biotronik.com/manuals/home
•
Consider all relevant technical manuals.
•
Keep technical manuals for further use.
Care during shipping and storage
•
Devices must not be stored or transported close to magnets or sources of electro-
magnetic interference.
•
Note the effects of the storage duration; see Battery Data.
Delivery in shipment mode
The device is delivered in shipment mode to protect the battery; capacitor reforming
required during storage could result in controlled extended charge times of the shock
capacitors.
•
The shipment mode is displayed on the programmer after loading the device
program (it is deactivated during implantation on initial measurement of the pacing
impedance).
Temperature
Extremely low and high temperatures affect the service time of the battery in the
device.
•
Temperatures of 5°C to 45°C are permitted for transport, storage, and use.
Sterile delivery
The device and the screwdriver have been gas-sterilized. Sterility is guaranteed only if
the blister and quality control seal have not been damaged.
Sterile packaging
The device and screwdriver are packaged in two separately sealed blisters. The inner
blister is also sterile on the outside so that it can be transferred in a sterile state during
implantation.
Single use only
The device and screwdriver are intended for single use only.
•
Do not use the device if the package is damaged.
•
The device must not be resterilized and reused.
Possible Complications
General information on medical complications
Complications for patients and device systems generally recognized among practitio-
ners also apply to BIOTRONIK devices.
•
Normal complications may include fluid accumulation within the device pocket,
infections, or tissue reactions. Primary sources of complication information include
current scientific and technological knowledge.
•
It is impossible to guarantee the efficacy of antitachycardia therapy, even if the
programs have proven successful during tests or subsequent electrophysiological
examinations. In rare cases the set parameters may become ineffective. It is
possible for therapies to induce or accelerate tachycardia and cause sustained
ventricular flutter or fibrillation.
Skeletal myopotentials
Bipolar sensing and control of sensitivity are adapted by the device to the rate spectrum
of intrinsic events so that skeletal myopotentials are usually not recorded. Skeletal
myopotentials can nonetheless be classified as intrinsic events especially at very high
sensing sensitivity and, depending on the interference, may cause inhibition or antiar-
rhythmia therapy.
In the case of undesired myopotentials, the device switches to asynchronous pacing if
the interference rate is exceeded.