Safety during Use
Current Software Version
5
Current Software Version
The function of the device depends on the correct software version of the Renamic programmer.
1.
Make sure that the current software version is installed on Renamic.
At least PSW software version 2201 or higher must be installed on it. The device does not work with
older software versions.
Software is available for download on the internet at software.biotronik.com, or by contacting
BIOTRONIK.
Setup Location
•
Only operate the device in rooms that fulfill the following conditions:
–
Suitable for medical purposes
–
No danger of explosion
•
Place the device on a flat, dry surface.
•
The device should be placed in a manner that does not allow it to slip, even while the cable is
connected, and so that it is protected against liquids and moisture. Also, ensure that the patient
only comes into contact with the applied parts, namely the programming head, ECG cable, and
patient cable for the PSA on the programmer.
•
Make sure that you can easily connect and disconnect the USB connector.
•
To avoid interference, place the device at least 30 cm away from other radio equipment.
•
Do not touch any exposed plug connections such as USB ports and the patient at the same time.
Test before Each Use
A short test should be performed prior to each use of the device. This includes a visual inspection:
1.
Inspect the housing for mechanical damage, dents, loose parts, cracks, etc.
2.
Inspect the cables (for insulation, fractures, etc.) and cable connection areas.
3.
Perform a simple electrical function test: With the device connected, switch on the Renamic
programmer.
If you find any damage or failures, please contact BIOTRONIK.
Connecting
The function of the device can only be used with the BIOTRONIK Renamic programmer. Ensure the
following conditions are met:
•
The Renamic must be equipped with a certificate for communication with BIOTRONIK. This is
ensured for devices that are already equipped with a UMTS module. You can tell whether the
Renamic is equipped with a UMTS module by the "UMTS" identification on the backside of the
Renamic.
•
To avoid interference in communication, do not connect the device to the Renamic during
implantation or follow-ups.
•
DataBridge must be connected to the Renamic USB port.
•
Only one DataBridge may be connected to a Renamic.
•
Do not touch any exposed plug connections such as USB ports and the patient at the same time.
