BIOTRONIK DataBridge User manual

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 [phone]
Fax [phone]
[email protected]
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 5cm 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
[Page5].

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
– Aerodesin2000 (manufactured by Lysoform Dr.HansRosemannGmbH)
• Hydrogen peroxide-based disinfectant
– 2-percent solution for use with terralin® PAA (manufactured by Schülke&MayrGmbH)
• Quaternary compound-based disinfectant
– 2-percent solution for use with terralin® protect (manufactured by Schülke&MayrGmbH)
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 (WEEE2).
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 (WEEE2) 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 ≥ 2.5mm 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.

Start-up
Transportation
9
Transportation
On the bottom side of the device there are two hook and loop fasteners with which you can fasten the
device to the lid of the power cord compartment of the Renamic. Furthermore, a self-adhesive cable
holder is included in the package contents for attaching the USB cable close to the Renamic housing.
These aids enable you to attach the device to the Renamic for transportation so that you can transport
DataBridge and the Renamic as one unit.
1. Clean the power cord compartment lid.
Proceed as described in the Renamic technical manual.
2. Position DataBridge over the power cord compartment lid and find a suitable position for the hook
and loop fasteners.
3. Peel off the protective films of the hook and loop fasteners.
4. Check the suitable position and attach DataBridge to the lid using the adhesive surfaces.
5. Find a suitable place for the cable holder on the housing side of the Renamic (e.g., above the USB
port used).
6. Clean this surface as well.
7. Peel off the protective film from the adhesive surface of the cable holder.
8. Position the cable holder and attach it to the Renamic.
9. Clamp the USB cable into the cable holder. Make sure that the cable is not subjected to tensile
stress and that it is as close to the Renamic as possible.

Appendix
Technical Data
10
4 Appendix
Technical Data
Category Design
Dimensions (WxDxH) 320mmx160mmx50mm /
12.6''x6.3''x1.9''
Weight 190g / 0.419lbs
Degree of protection IP30
Sterilization Non-sterile
Longevity 6years
Operating mode Continuous operation
Power supply to the device Operation via the Renamic USB port
On/Off light indicator Green LED, lit continuously
Disclosure pursuant to
Section33REACH,
Regulation (EC) No.1907/2006
See:
https://www.biotronik.com/material-compliance
Ambient conditions
Category Operation Transport and storage
Temperature +10°C…+40°C/
+50°F…+104°F
0°C…+50°C/
+32°F…+122°F
Relative humidity 20%…75%, non-condensing
Atmospheric pressure 700hPa…1060hPa
Mobile specifications
Category Design
Max. power of transmission +23dBm (Class3)
Max. data rate LTE‑CAT1
Download: 10Mbit/s
Upload: 5Mbit/s
Bandwidth Up to 20MHz
Modulation Download QPSK, 16‑QAM, 64‑QAM
Upload QPSK, 16‑QAM

Appendix
Package Contents
11
Category Design
Model Europe Telit LE910C1‑EU
North America Telit LE910C1‑NA
Asia-Pacific Telit LE910C1‑AP
Latin America Telit LE910C1‑LA
LTE bands in use Europe B1(1,900MHz), B3(1,800MHz), B7(2,600MHz),
B8(900MHz), B20(800MHz), B28A(700MHz)
North America B2(1,900MHz), B4(1,700/2,100MHz),
B12(700MHz)
Asia-Pacific B1(1,900MHz), B3(1,800MHz), B5(850MHz),
B28(700MHz)
Latin America B1(2,100MHz), B3(1,900MHz), B3(1,800MHz),
B4(1,700/2,100MHz), B7(2,600MHz),
B28(700MHz)
Package Contents
Information about the package contents can be found on the shipping label.
Electromagnetic Interferences
Possible electromagnetic interference
This device is protected against electromagnetic interference and electrostatic discharges in the
special environment in the vicinity of high-frequency surgical instruments. At the same time, the
emitted interference is reduced to a minimum. The device thus meets all requirements of
IEC60601-1-2.
The following tests were conducted according to IEC 60601‑1‑2:2014:
Section Test Test level
7.1 EN55011 (CISPR11)
Radiated emission
• Group1
• ClassB
8.9 IEC61000‑4‑2
Electrostatic discharge (ESD)
• ±8kV contact discharge
• ±15kV air discharge
8.9/8.10 IEC61000‑4‑3
Electromagnetic fields
• Modulation: 1kHz
• 3V/m, 80MHz– 2.7GHz
• Limits for RF communication
equipment per Table9 in
IEC60601-1-2 (9–28V/m)

Appendix
Electromagnetic Interferences
12
Section Test Test level
8.9 IEC61000‑4‑6
Conducted radiofrequency interference
• Modulation: 1kHz
• 3V
• 6V in ISM bands
IEC61000‑4‑8
AC frequency magnetic fields
• 30A/m
• 50/60Hz
8.11 IEC 61000‑4‑39
Proximity magnetic fields
• Limits according to Table11 in
IEC60601‑1‑2 (7.5–65 A/m)
However, strong electromagnetic interferences that occur in the close vicinity of electrical motors,
power cables, PCs, monitors, or other, possibly defective, electrical devices may compromise the
function of the device.
This kind of device malfunction should be considered as a possible cause if the following is observed:
• The device switches on unintentionally.
• The device displays other abnormal behavior.
Correct operation of the device can be restored by the following methods:
• Switch off the interfering electrical device.
• Remove the source of interference from this device.
• Switch this device on and off or break the electrical connection between this device and the source
of interference, if this can be done safely.
If the interference continues, contact BIOTRONIK immediately.
Caution
Risk of electromagnetic interference
The use of this device close to or in direct contact with other devices should be avoided, as this may
lead to the device operating incorrectly.
• Where usage in such a manner is unavoidable, you should monitor this device and the other
device(s) being used with it in order to ensure that they are all working correctly.
WARNING
Risk of electromagnetic interference through the use of unauthorized accessories
The use of accessory parts, transducers, or cables not listed by BIOTRONIK, or other than those
specified by BIOTRONIK, can produce elevated electromagnetic emissions or cause degradation in
the device's resistance to electromagnetic interference. Such effects can lead to the faulty
operation of the device.
• Only use accessories authorized by BIOTRONIK.
WARNING
Risk of electromagnetic interference through the use of portable RF communication equipment
If portable RF communication devices (including peripheral devices such as antenna cables and
external antennae) are operated closer than 30cm (12inches) from this device, this can result in a
reduction in its performance. This applies even when using associated cables.
• When operating portable RFcommunication devices (including peripheral devices such as
antenna cables and external antennae), keep such devices at a distance of at least 30cm
(12inches) from this device.

Appendix
Country-Related Information
13
Country-Related Information
International Radio Certification
Telemetry information for Australia:
This device is in compliance with the Australian "Radiocommunications Act 1992" and, therefore, it
is labeled with the Regulatory Compliance Mark (RCM) in accordance with the requirements for
radiocommunication devices.
Telemetry information for Canada:
This device will be registered with Innovation, Science and Economic Development Canada under the
following number:
IC: 4708A‑DATABRIDGE
Telemetry information for the USA:
This device complies with Part 15 of the FCC Rules.
Operation is subject to the following two conditions:
1. This device may not cause harmful interference, and
2. This device must accept any interference received, including interference that may cause
undesired operation
Changes or modifications not expressly approved by the party responsible for compliance could void the
user's authority to operate the equipment.
Note
This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This device generates, uses, and can
radiate radio frequency energy and, if not installed and used in accordance with the instructions,
may cause harmful interference to radio communications. However, there is no guarantee that
interference will not occur in a particular type of installation. If this device does cause harmful
interference to radio or television reception, which can be determined by turning the device off
temporarily and then turning it on again, you may try to correct the interference by one or more of
the following measures:
• Changing the orientation or location of the receiving antenna.
• Increasing the distance between the device and receiver.
• Connecting the device to an outlet on a circuit different from that to which the receiver is
connected.
• Consulting the distributor or an experienced radio/TV technician for help.
This device will be registered with the Federal Communications Commission under the following
number:
FCC ID: QRI‑DATABRIDGE

Appendix
Legend for the Label
14
Legend for the Label
Symbol Meaning
Medical device
Manufacturing date
BIOTRONIK order number
Serial number
Unique device identifier
Temperature limit
Humidity limit
Air pressure limit
manuals.biotronik.com
Follow the instructions for use!
Contents
Do not use if packaging is damaged and consult
the technical manual
Manufacturer
Distributor
Caution: Federal law (USA) restricts this device to
sale by or on the order of a physician.

Appendix
Legend for the Label
15
Symbol Meaning
Device contains materials that must be correctly
disposed of in accordance with environmental
protection regulations. The European Directive
2012/19/EU on waste electrical and electronic
equipment (WEEE2) applies. Return devices that
are no longer used to BIOTRONIK.
DataBridge
Renamic
Cable holder