Magnetic resonance imaging
Magnetic resonance imaging (MRI) is contraindicated 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
failures of the device:
• Keep an external defibrillator and paddles or patch electrodes ready.
Unpacking the device
WARNING
®
.
Inadequate therapy due to defective device
If an unpacked device is dropped on a hard surface during handling, electronic parts
could be damaged.
• Use a replacement device.
• Return the damaged device to BIOTRONIK.
• Peel the sealing paper off of the outer blister at the marked position in the direction
indicated by the arrow. The inner blister must not come into contact with persons
who have not sterilized their hands or gloves, nor with non-sterile instruments!
• Take hold of the inner blister by the gripping tab and take it out of the outer blister.
• Peel the sealing paper off of the sterile inner blister at the marked position in the
direction indicated by the arrow.
Checking parts
Damage to any of the parts can result in complications or technical failures.
• Check for damage before and after unpacking all parts.
• Replace damaged parts.
• The ICD is shipped with tachyarrhythmia therapy deactivated and is only to be
connected and implanted in this state.
• Leads must not be shortened.
Implantation site
• Depending on lead configuration and the patient's anatomy, the ICD is generally
implanted subpectorally on the left side.
Preventing leakage currents
Leakage currents between the tools and the device must be prevented during implanta-
tion.
• Electrically insulate the patient.
8