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
11
Radiation therapy
The use of radiation therapy must be avoided due to possible damage to the device and
the resulting impaired functional safety. If this type of therapy is to be used anyway,
prior risk/benefit analysis is absolutely necessary. The complexity of influencing
factors such as different sources of radiation, a variety of devices and therapy condi-
tions makes it impossible to issue directives that guarantee radiation therapy without
an impact on the device. The EN 45502 standard pertaining to active implantable
medical devices requires the following measures during the administration of thera-
peutic ionizing radiation:
•
Adhere to instructions for risky therapy and diagnosis procedures.
•
Shield device against radiation.
•
After applying radiation, double-check the device system to make sure it is func-
tioning properly.
Magnetic resonance imaging
Magnetic resonance imaging (MRI) must be avoided due to the high frequency fields
and the associated magnetic flux density: damage or destruction of the device system
by strong magnetic interaction and damage to the patient by excessive warming of the
body tissue in the area surrounding the device system.
Under certain conditions and when maintaining mandatory measures to protect the
patient and device system, magnetic resonance imaging can be performed. BIOTRONIK
devices with the "MR conditional" function bear the identification ProMRI
®
.
•
The ProMRI
®
manual – MR conditional device systems – contains detailed informa-
tion on safely conducting an MRI.
—
Download the digital manual from the web site:
www.biotronik.com/manuals/manualselection
—
Order the printed manual from BIOTRONIK.
•
Does approval as "MR-Conditional" apply in your country or region? Request
current information from BIOTRONIK.
3 Implantation
Implantation Procedure
Having parts ready
The following parts that correspond to the requirements of the EC Directive 90/385/EEC
are required:
•
BIOTRONIK device with blind plug and screwdriver
•
BIOTRONIK leads and lead introducer set
—
Single-chamber device: One bipolar ICD lead with 1 or 2 shock coils for the
ventricle
—
Dual-chamber device: One bipolar lead for the atrium and one bipolar ICD lead
for the ventricle with 1 or 2 shock coils
—
Triple-chamber device: an additional unipolar or bipolar LV lead
•
DF-1, DF4 and IS-1 connections are approved. For leads with a different connection
or leads from other manufacturers, use adapters approved by BIOTRONIK only.
•
BIOTRONIK programmer (with integrated SafeSync RF telemetry or with separate
SafeSync Module) and approved cable
•
External multi-channel ECG device
•
Keep spare parts for all sterile components.
Keeping an external defibrillator ready
In order to be able to respond to unforeseeable emergencies or possible technical fail-
ures of the device:
•
Keep an external defibrillator and paddles or patch electrodes ready.
Note:
Please contact BIOTRONIK with questions during the risk/benefit analysis.