About the Device
Intended user
2
1
About the Device
General Description
DataBridge is connected to the BIOTRONIK Renamic programmer. If the Renamic is equipped with a
certificate for communication with BIOTRONIK, information is transmitted via the 4G mobile network
(LTE) using DataBridge. The information can be transmitted from the programmer to BIOTRONIK and
vice versa.
Objective
In this technical manual, you will find information on how to use DataBridge. Topics such as start-up,
cleaning and disinfection, disposal and transport, among other things, are explained.
This technical manual does not contain any information on the Renamic programmer or its functions.
For a description of these functions, refer to the technical manuals of the programmer and the
associated software of the programmer. You will also find information in the technical manual of the
programmer arising from its use, such as operating environments or use with high-frequency surgical
instruments.
Intended Purpose
DataBridge provides capabilities for cellular communication between the Renamic programmer and
cellular mobile networks.
Indications, Contraindications, and Expected Clinical Benefit
DataBridge is used exclusively for the transmission of information via mobile networks. Therefore, it
has no indications, no contraindications, and no expected clinical benefit.
Residual Risk
The risk analysis carried out by the manufacturer's Risk Management team has determined that the
residual risk is at the lowest possible level. Prerequisites for this are the intended use of a device that
has been serviced and inspected according to the manufacturer's specifications by qualified medical
staff and the compliance with the safety-relevant instructions in this technical manual.
Intended user
The use of the device and the technical manual are intended for trained and experienced physicians,
hospital technicians and nursing staff, general practitioners, as well as sales representatives of
BIOTRONIK, who are familiar with the following topics:
•
Use of implantable pacemakers, ICDs, or implantable cardiac monitors (ICMs)
•
Risks and possible contraindications accompanying the use of these systems
•
Experience with programmers for implantable devices
The user of the programmer performs:
•
Follow-up and emergency follow-up
•
Implantation support with post-implantation follow-up
BIOTRONIK offers user trainings for specific target groups. Current information on training and
education opportunities can be requested from: [email protected]
