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Parts
The device system consists of the following parts:
• Device with connections for unipolar or bipolar sensing and pacing
• Suitable leads, adapters and approved accessories
• Programmer
• Current software
Device
The device'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 devices to avoid muscle twitching near the
implanted pacemaker in the case of unipolar pacing. The labeling provides information
about the device type and arrangement of the connections.
Leads
The leads are coated with biocompatible silicone. They can be flexibly maneuvered, are
stable long-term, and are equipped for active or passive fixation. They are implanted
using a lead introducer set. Some leads are coated with polyurethane which is known to
increase the sliding properties for the lead. The coating of steroid-eluting leads
reduces inflammatory processes. The fractal design of the leads allows for low pacing
thresholds, high pacing impedance, and a low risk of oversensing.
Programmer
The portable programmer is used to transfer the current software to the device. In
addition to this, the programmer is used for interrogation and storage of data from the
device. The programmer acts as an ECG and IEGM monitor.
The programmer communicates with the device via the programming head. It has a TFT
touch screen with a color display, on which the ECG, IEGM, markers and functions are
shown simultaneously. The programmer functions include the following:
• Perform all tests during in-office follow-up
• Display and print real-time and saved IEGMs with annotated markers
• Determine the pacing threshold
BIOTRONIK Home Monitoring
®
In addition to effective pacing therapy, BIOTRONIK provides a complete therapy
management system:
• With Home Monitoring, diagnostic and therapeutic information and technical data
are automatically sent to a stationary or mobile transmitter via an antenna in the
device's header. The data are encrypted and sent from the transmitter to the
BIOTRONIK Service Center via the cellular phone network.
• The received data are deciphered and evaluated. Each physician can set the criteria
for evaluation to be used for each patient and can configure the time of notification
via e-mail, SMS or fax.
• A clear overview of the results of this analysis is displayed for the attending physi-
cians on the protected internet platform Home Monitoring Service Center (HMSC).
• Data transmission from the device is performed with a daily device message.
• Device messages, which indicate special events in the patient's heart or in the
device, are forwarded immediately.
• A test message can be initiated at any time using the programmer to immediately
check the Home Monitoring function.
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
• Technical manual for software as online help on the user interface and as a PDF
file in the Manual Library at www.BIOTRONIK.com
• Technical manuals for the leads
• Technical manuals for cables, adapters and accessories
Note:
It is not permitted to use the device's ECG display for diagnostic purposes
because it does not meet all requirements of the norm (IEC 60601-2-25) concerning
diagnostic ECG devices.
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