6
Order numbers Eluna
The devices can be obtained as follows:
Package contents
The storage package includes the following:
• Sterile packaging with device
• Serial number label
• Patient ID card
• Warranty booklet
The sterile container includes the following:
• Device
• Screwdriver
Diagnostic and Therapy Functions
General overview
All the systems have extensive features that allow quick diagnosis and delivery of safe
therapy for bradycardia conditions.
• Automatic functions make it easy and fast to implant, configure, and check the
pacemaker.
• Auto-initialization after implantation: The device recognizes the implanted leads
autonomously and sets the polarity. The automatic functions of the software are
activated after 10 min.
Diagnostic functions
• Data from the last 10 interrogations and follow-ups are recorded as well as
arrhythmia episodes; they are stored together with other data to assess patients
and the state of the device at any time.
• Continuous automatic below-threshold impedance measurements are performed
in the device independent of the pacing pulse in order to check the lead for proper
functioning.
• Once a telemetry connection has been established during a test procedure in
an in-office follow-up, the IEGM is displayed with markers.
Antibradycardia pacing
• Sensing: The amplitudes of the P and R waves are measured in the implanted
device fully automatically to record varying amplitudes. The sensitivity for the
atrium and ventricle is adapted automatically on an ongoing basis. The measure-
ment data are averaged and the trend can be displayed.
• Thresholds: atrial as well as ventricular pacing thresholds are automatically deter-
mined in the device. Capture control is used to set the pulse amplitudes so that
pacing is performed with the optimum atrial and ventricular amplitude for the
patients with each change of the pacing threshold.
• Timing: Pacing in the atrium is checked particularly carefully by an automatic adap-
tation of the atrial refractory period in order to avoid pacemaker-mediated tachy-
cardia (Auto PVARP function: the postventricular atrial refractory period is adapted
automatically).
• Additional, special form of rate adaptation with devices from the 8 series: an
increased cardiac output requirement is detected using physiological impedance
measurement. The measuring principle is based on contractile changes (ionotropy)
of the myocardium (CLS function: Closed Loop Stimulation). Rate adaptation is
automatically initialized and optimized in CLS mode.
• Ventricular pacing suppression: unnecessary ventricular pacing is avoided by
promoting intrinsic conduction (Vp suppression function). The device can adapt
itself to conduction changes. In the case of intrinsic conduction, the device switches
to a DDD(R)-ADI(R) mode.
Device type
Eluna 8
Eluna 8 ProMRI
SR
394939
394972
SR-T
394934
394971
DR
394927
394970
DR-T
394929
394969
HF-T
394917
394968
Note:
The technical manual pertaining to the device is either included in hard copy
form in the storage package or in digital form on the internet.
401303--G_GA_Eluna-I-ProMRI_mul.book Page 6 Friday, October 2, 2015 4:57 PM
