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BIOTRONIK 4035479BUDI00052Q5, Technical Manual

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BIOTRONIK 4035479BUDI00052Q5 Technical Manual Download Page 2

© 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
[email protected]
www.biotronik.com

Summary of Contents for 4035479BUDI00052Q5

Page 1: ...DataBridge Accessories for transmitting information via the 4G mobile network LTE Technical Manual 466846 Revision A 2021 12 06 ...

Page 2: ...ation 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 sales biotronik com www biotronik com ...

Page 3: ...s 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 Packa...

Page 4: ...cal 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 th...

Page 5: ...vice 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 compet...

Page 6: ... 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 ...

Page 7: ...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...

Page 8: ...nfectant 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 equ...

Page 9: ...p 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 ...

Page 10: ...ice 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 DataBridg...

Page 11: ...ribed 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...

Page 12: ...reen 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 dB...

Page 13: ...ng 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 con...

Page 14: ...terference 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 unauthoriz...

Page 15: ... 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 r...

Page 16: ...ial 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 ...

Page 17: ...als 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 ...

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