BIOTRONIK DataBridge Manuel utilisateur
DataBridge
Accessories for transmitting
information via the 4G mobile
network (LTE)
Technical Manual
466846
Revision: A (2021-12-06)
© BIOTRONIK SE & Co. KG
All rights reserved.
Specifications subject to modification, revision and
improvement.
® All product names in use may be trademarks or
registered trademarks held by BIOTRONIK or the
respective owner.
BIOTRONIK SE & Co. KG
Woermannkehre 1
12359 Berlin / Germany
Tel +49 (0) 30 68905-0
Fax +49 (0) 30 6852804
www.biotronik.com
Table of Contents
1
Table of Contents
1 About the Device......................................................................................................... 2
General Description.......................................................................................................................... 2
Objective ............................................................................................................................................ 2
Intended Purpose.............................................................................................................................. 2
Indications, Contraindications, and Expected Clinical Benefit ....................................................... 2
Residual Risk .................................................................................................................................... 2
Intended user .................................................................................................................................... 2
Product identification........................................................................................................................ 3
Reporting of Serious Incidents......................................................................................................... 3
2 Safety during Use ....................................................................................................... 4
Safety Messages ............................................................................................................................... 4
Technical Manuals............................................................................................................................ 4
Liquids ............................................................................................................................................... 4
Changes not permitted..................................................................................................................... 4
Using in combination with high-frequency devices......................................................................... 4
Current Software Version................................................................................................................. 5
Setup Location .................................................................................................................................. 5
Test before Each Use........................................................................................................................ 5
Connecting ........................................................................................................................................ 5
Cleaning and Disinfection................................................................................................................. 6
Sterilization ....................................................................................................................................... 6
Disposal............................................................................................................................................. 6
3 Start-up ...................................................................................................................... 7
Device Overview ................................................................................................................................ 7
Symbols on the Device...................................................................................................................... 7
Connecting the Device ...................................................................................................................... 8
Switching On and Off......................................................................................................................... 8
Transportation .................................................................................................................................. 9
4 Appendix ..................................................................................................................... 10
Technical Data .................................................................................................................................. 10
Package Contents............................................................................................................................. 11
Electromagnetic Interferences ........................................................................................................ 11
Country-Related Information ........................................................................................................... 13
Legend for the Label......................................................................................................................... 14
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]
About the Device
Product identification
3
Product identification
Each product is identified by a so-called unique device identification (UDI), which contains product-
specific information. In addition, a basic identifier called B-UDI-DI (basic – unique device identification –
device identifier) is assigned to several products.
The B-UDI-DI is: 4035479BUDI00052Q5
Using this B-UDI-DI, it will be possible to search the European Database on Medical Devices
(EUDAMED) for additional information on the product.
Reporting of Serious Incidents
Report any serious incident that has occurred with the device to the manufacturer and to the competent
authority.
The competent authority can be found at: https://ec.europa.eu
Safety during Use
Using in combination with high-frequency devices
4
2 Safety during Use
Safety Messages
WARNING
Safety information
The installation and use of the device are subject to special operating conditions and possible
complications and risks.
• Pay careful attention to all the safety information in this section and in the entire technical
manual.
WARNING
Function impairment due to damage
Mechanical impact, for example dropping the unit – even from a height of just 5cm if unpackaged
– can permanently impair the function of the device.
• Do not use the device if it shows visible damage.
Technical Manuals
Technical manuals are either included in hard copy form in the storage package or available in digital
form on the internet: https://manuals.biotronik.com.
1. Consult all relevant technical manuals.
2. Keep the technical manuals for future reference.
To ensure safe operation, in addition to this technical manual, please also consult the following
technical manuals:
• Technical manuals for the programmer and its accessories
• Technical manuals for the programmer's software
• Technical manuals for other devices, such as external monitors
Liquids
• Never use a damp or wet device.
• Protect the device from accidental ingression of fluids (e.g., infusion fluids).
• Protect the device from condensation.
Changes not permitted
Only the manufacturer BIOTRONIK or a party expressly authorized by the manufacturer may perform
corrective maintenance, enhancements, or modifications to the device.
Using in combination with high-frequency devices
The device is protected against damage when using it in conjunction with high-frequency surgical
instruments. Even though this protection was tested, its effectiveness depends on the strength, wave
shape, and transmission path of the induced current.
• Perform a test after any application with HF surgical equipment, see Test before Each Use
[Page5].
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.
Safety during Use
Disposal
6
Cleaning and Disinfection
Clean the device with a damp cloth and a mild soap solution with a pH value between 4 and 10.
For disinfecting, use an alcohol-based, hydrogen peroxide-based, or quaternary compound-based
disinfectant. The disinfection of the device was tested using the following agents:
• Alcohol-based disinfectant
– Mixture of 70% isopropyl and 30% water
– Mixture of 85% ethanol and 15% water
– Aerodesin2000 (manufactured by Lysoform Dr.HansRosemannGmbH)
• Hydrogen peroxide-based disinfectant
– 2-percent solution for use with terralin® PAA (manufactured by Schülke&MayrGmbH)
• Quaternary compound-based disinfectant
– 2-percent solution for use with terralin® protect (manufactured by Schülke&MayrGmbH)
Sterilization
The device is non-sterile and must not be sterilized. Follow the instructions on cleaning and
disinfecting.
Disposal
The symbol on the type plate, a crossed out garbage can, indicates that the device must be disposed of
in accordance with Directive 2012/19/EU on waste electrical and electronic equipment (WEEE2).
Disposal of this device in an environmentally unfriendly manner will result in environmental pollution,
as this device contains materials that must be disposed of in accordance with environmental protection
regulations (e.g., WEEE, RoHS, REACH). Dispose of the used product in an environmentally sound
manner and according to the applicable country-specific directives. Return products that are no longer
in use to BIOTRONIK.
Start-up
Device Overview
7
3 Start-up
Device Overview
View from the top
1 On/Off light indicator
(Lights up only when the device is connected and the Renamic is switched on.)
2 USB connector
View from the bottom
3 Hook and loop fasteners to attach to the Renamic for transportation
Symbols on the Device
Manufacturer
Medical device
Serial number
Manufacturing date
Unique device identifier
Device contains materials that must be correctly disposed of in accordance with environ-
mental protection regulations. European Directive 2012/19/EU on waste electrical and elec-
tronic equipment (WEEE2) applies. Return devices that are no longer used to BIOTRONIK.
Start-up
Switching On and Off
8
CE mark
IP30 • Protection against the ingress of solid foreign bodies with a ≥ 2.5mm diameter
• No protection against ingress of water
Regulatory compliance mark (RCM)
Connecting the Device
Prerequisite
• The Renamic is equipped with a certificate for communication with BIOTRONIK.
• No other DataBridge is connected to the Renamic.
• The Renamic is not being used for an implantation or follow-up at the time of connecting it.
1. Check that at least PSW software version 2201 or higher is installed on the Renamic. If an older
software is installed, you must update and install the latest software.
2. Switch off the Renamic.
3. Connect the USB connector of the device to the Renamic USB port.
4. Switch on the Renamic.
Result
When the Renamic is ready for use after successful start-up, the DataBridge on/off light indicator turns
green. On the Renamic user interface, the number [4] is displayed in the status bar next to the symbol
for the signal strength of the mobile connection.
On/Off light indicator
The on/off light indicator is located on the top side of DataBridge. It is an open circle. The on/off light
indicator is only visible and continuously lit green when DataBridge is connected and the Renamic is
turned on.
Switching On and Off
The device does not have its own on/off key. When DataBridge is connected to the Renamic, it can only
be switched on or off by switching the Renamic on or off.
Switching on
1. Switch on the Renamic.
Switching off
1. Switch off the Renamic.
Or
Disconnect the USB connector of the device from the Renamic USB port.
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