Implantation; Implantation Procedure - BIOTRONIK Evity 6 Manuel Technique

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
therapeutic ionizing radiation:
• Adhere to instructions for potentially risky therapeutic and diagnostic procedures.
• Shield device against radiation.
• After applying radiation, double-check the device system to make sure it is
functioning properly.
Note: Please contact BIOTRONIK with questions on the risk/benefit analysis.
Magnetic resonance imaging
Magnetic resonance imaging must be avoided due to the associated high frequency
fields and 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 the 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:
manuals.biotronik.com
— Order the printed manual at BIOTRONIK.
• Does approval as "MR conditional" apply in your country or region?
Ask for current information at BIOTRONIK.
en • English

3 Implantation

Implantation Procedure

Having parts ready
The following parts that correspond to the requirements of the EC Directive 90/385/EEC
are required:
• Device with screwdriver from BIOTRONIK
• BIOTRONIK leads and lead introducer set
— Single-chamber device: unipolar or bipolar lead for the right ventricle
— Dual-chamber device: one unipolar or bipolar lead each for the atrium and for
the right ventricle
— Triple-chamber device: an additional unipolar, bipolar, or quadripolar LV lead
• Approved connections are IS-1 and IS4: Use only adapters approved by BIOTRONIK
for leads with different connections or leads from other manufacturers.
• BIOTRONIK programmer (with integrated wandless telemetry or with separate
SafeSync Module) and approved cables
• 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 adhesive electrodes ready.
Unpacking the device
W 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.
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