6 Product Description
System Overview
Parts The implant system consists of the following parts:
• Implant with connections for unipolar or bipolar sensing and pacing
• Suitable leads and approved accessories
• Programmer
• Current implant programs
Implant The implant's housing is made of biocompatible titanium, welded from outside and
thus hermetically sealed. The ellipsoid shape facilitates ingrowth into the pectoral
muscle area.
The housing serves as an antipole in the case of unipolar lead configuration.
BIOTRONIK provides silicone-coated implants to avoid muscle twitching near the
implanted pacemaker in the case of unipolar pacing.
The labeling provides information about the implant type and arrangement of the
connections.
Leads The leads are sheathed with biocompatible silicone. They can be flexibly maneu-
vered, are long-term stable, and are equipped for active or passive fixation. They
are implanted using a lead introducer set. Some leads are coated with polyurethane
to increase the sliding properties of the lead.
The coating of steroid-eluting leads reduces inflammatory processes. The fractal
design of the leads provides for low pacing thresholds, high pacing impedance, and
a low risk of oversensing.
Programmer The transportable programmer is used to transfer the appropriate implant pro-
gram to the implant. In addition to this, the programmer is used for interrogation
and storage of data from the implant. And it acts as an ECG and IEGM monitor with
Miniclinic.
The programmer communicates with the implant via the programming head. The
operation module of the programmer has a TFT touch screen with color display, on
which the ECG, IEGM, marker and functions are shown simultaneously.
The programmer has, among others, the following functions:
• Perform all tests during follow-up
• Display and print real-time and saved IEGMs with annotated markers
• Determine the pacing threshold
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