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Radiation therapy
The use of radiation therapy is contraindicated due to possible damage to the device
and the resulting impaired functional safety. If this type of therapy is to be administered
anyway, prior risk/benefit analysis is absolutely necessary. The complexity of influ-
encing factors such as different sources of radiation, a variety of devices and therapy
conditions makes it impossible to issue directives that guarantee radiation therapy
without an impact on the device. The EN 45502 standard pertaining to active implant-
able medical devices requires the following measures during the administration of
therapeutic 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 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.
• The ProMRI
®
manual – MR conditional device systems – contains detailed informa-
tion on safely conducting an MR scan.
— 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 Prior to Implantation
Indications and Contraindications
Guidelines of cardiologic societies
Generally approved differential diagnostics methods, indications, and recommenda-
tions for pacemaker therapy apply to BIOTRONIK devices.
The guidelines provided by cardiology associations offer decisive information.
Indications
We recommend observing the indications published by the German Cardiac Society
(Deutsche Gesellschaft für Kardiologie, Herz- und Kreislaufforschung) and the ESC
(European Society of Cardiology). Likewise those published by the Heart Rhythm
Society (HRS), the American College of Cardiology (ACC), the American Heart Associa-
tion (AHA) as well as other national cardiology associations.
Contraindications
No contraindications are known for the implantation of multifunctional triple-chamber
devices, provided differential diagnostics precedes implantation according to the
appropriate guidelines and no modes or parameter combinations are configured which
pose a risk to the patient.
Ambient Conditions
Temperature
Extremely low and high temperatures affect the service time of the battery in the
device.
• The following temperatures are permitted for transport, storage, and use:
–10°C to 45°C
Storage location
• Devices are not to be stored close to magnets or sources of electromagnetic inter-
ference.
Storage period
The duration of storage affects the service time of the battery of the device (see battery
data).
• Please note the use by date.
Note:
Please contact BIOTRONIK with questions during the risk/benefit analysis.
Note:
The compatibility and effectiveness of parameter combinations must be
checked after programming.
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