General Safety Instructions; Operating Conditions - BIOTRONIK ProMRI Eluna 8 SR-T Manuel Technique

Resynchronisation therapy
Triple chamber devices have functions to configure different VV delays in order to
resynchronize the ventricles.
• Capture Control is available for the left ventricle with automated tracking of the
pacing threshold or automatic threshold monitoring (ATM) for trend analysis.
• To ensure that no additional surgery is necessary in case of a left-sided increase of
pacing threshold or undesired phrenic nerve stimulation, different pacing polarities
can be set for the left ventricular lead with a triple-chamber device.
• An additional diagnostic function with biventricular pacing: variability of the heart
rate, the patient activity and the thoracic impedance are monitored on a continual
basis.
Programs
There are two types of therapy programs:
• Default parameters are offered for the most common indications (Program Consult
function).
• Individual settings can be saved in 3 individual therapy programs.
Home Monitoring functions
The device automatically sends information to the transmitter once a day. Additionally,
the test messages can be initiated using the programmer. Important medical informa-
tion includes, among others, the following:
• Ongoing atrial and ventricular arrhythmia
• Parameters relevant to leads in the atrium and ventricle: thresholds, sensing
amplitudes, impedances
• Current statistics on bradycardia therapy
• Individually adjustable timing interval for device messages which provide additional
information pertaining to the device messages
®
• IEGM online HD with up to 3 high definition channels
• Transmission of these IEGM recordings along with device messages
en • English

2 General Safety Instructions

Operating Conditions

Technical manuals
The following technical manuals provide information about usage of the device
systems:
— Technical manual for the device
— Technical manual for the HMSC
— Technical manuals for the programmer and its accessories
— Technical manuals for the user interface
— Technical manuals for cables, adapters and accessories
• Technical manuals are either included in hard copy form in the storage package or
in digital form on the internet:
manuals.biotronik.com
• Follow all relevant technical manuals.
• Preserve technical manuals for later use.
Care during shipping and storage
• Devices are not to be stored close to magnets or sources of electromagnetic inter-
ference.
• Note the effects of the storage duration; see Battery Data.
Temperature
Extremely low and high temperatures affect the service time of the battery in the
device.
• Permitted for shipping and storage:
–10°C to 45°C
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 each packaged in 2 separately sealed blisters. The
inner blister is also sterile on the outside so that it can be transferred in a sterile state
during implantation.
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