Related Manuals for BIOTRONIK DataBridge
Summary of Contents for BIOTRONIK DataBridge
- Page 1 DataBridge Accessories for transmitting information via the 4G mobile network (LTE) Technical Manual 466846 Revision: A (2021-12-06)
- Page 2 BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin / Germany ® All product names in use may be trademarks or Tel +49 (0) 30 68905-0 registered trademarks held by BIOTRONIK or the Fax +49 (0) 30 6852804 sales@biotronik.com respective owner. www.biotronik.com...
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Page 3: Table Of Contents
Table of Contents Table of Contents About the Device ......................General Description .......................... Objective ............................Intended Purpose..........................Indications, Contraindications, and Expected Clinical Benefit ............Residual Risk ............................ Intended user ............................ Product identification........................Reporting of Serious Incidents......................Safety during Use ....................... Safety Messages .......................... -
Page 4: About The Device
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. -
Page 5: Product Identification
About the Device Product identification 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. -
Page 6: Safety During Use
• 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. -
Page 7: Current Software Version
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. -
Page 8: Cleaning And Disinfection
(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. -
Page 9: Start-Up
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. -
Page 10: Connecting The Device
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. -
Page 11: Transportation
Clean the power cord compartment lid. Proceed as described in the Renamic technical manual. Position DataBridge over the power cord compartment lid and find a suitable position for the hook and loop fasteners. Peel off the protective films of the hook and loop fasteners. -
Page 12: Appendix
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 See: Section 33 REACH, https://www.biotronik.com/material-compliance Regulation (EC) No. 1907/2006 Ambient conditions Category Operation Transport and storage Temperature +10°C … +40°C/ 0°C … +50°C/ +50°F … +104°F... -
Page 13: Package Contents
Appendix Package Contents 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),... - Page 14 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.
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Page 15: Country-Related Information
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... -
Page 16: Legend For The Label
Appendix Legend for the Label 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... - Page 17 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...
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