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Summary of Contents for BIOTRONIK BIOwand
- Page 1 BIOwand Device for wireless communication with the BIOTRONIK stimulator Technical Manual 452051 Revision: C -- DRAFT -- (2021-02-26)
- Page 2 © BIOTRONIK SE & Co. KG Distributor: Manufacturer: All rights reserved. BIOTRONIK, Inc. BIOTRONIK SE & Co. KG Specifications subject to modification, 6024 Jean Road Woermannkehre 1 revision, and Improvement. Lake Oswego, 12359 Berlin / Germany ® All product names in use may...
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Page 3: Table Of Contents
Telemetry Status Indicator on the Programming Head..............Setting up the Device ........................Connecting the Programming Head (BIOwand PGH)..............Connecting the Power Adapter and Switching on the Device............Establishing a Connection to the BIOwand App ................Establishing a Connection to a stimulator..................Error Resolution ..........................Appendix ........................ -
Page 4: Introduction
Intended use and contraindications The BIOwand is a medical accessory to the SCS system. It will be used in conjunction with off-the shelf hardware (commercial tablet or laptop) on which application tool for supporting stimulator software updates runs. -
Page 5: Safety During Use
Risk of electromagnetic interference through the use of unauthorized accessories The use of accessories, transducers, or cables not listed by BIOTRONIK or of accessories other than those specified by BIOTRONIK, can produce elevated electromagnetic emissions or cause degradation in the device's resistance to electromagnetic interference. -
Page 6: Operating Conditions
Authorized components Only use components authorized by BIOTRONIK for your own safety. The use of any other parts voids the warranty and eliminates the manufacturer's liability for any consequences. - Page 7 When used in combination with other devices, no portable multiple socket outlets may be used. • Only power supply adapter authorized by BIOTRONIK may be used. To disconnect the device from the mains supply, pull its power plug out from the outlet.
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Page 8: Electromagnetic Interferences
Safety during Use Electromagnetic Interferences Electromagnetic Interferences Possible electromagnetic interference This device is protected from electromagnetic interference and electrostatic discharges in a medical practice. At the same time, the emitted interference is reduced to a minimum. The device thus meets all requirements of IEC 60601‑1‑2. - Page 9 WARNING Risk of electromagnetic interference through the use of unauthorized accessories The use of accessories, transducers, or cables not listed by BIOTRONIK or of accessories 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 10: Care And Disposal
Disposal of this device and its components in an environmentally unfriendly manner will result in environmental pollution, as this device and its components contain materials that must be disposed of in accordance with environmental protection regulations (e.g., WEEE, RoHS, REACH). Return the following devices to BIOTRONIK: • Defective devices •... -
Page 11: Getting Started
Power adapter (FW8000M/12) with on/off light indicator and power plug Plug for connecting the power adapter to the device BIOwand Device Programming head connection (BIOwand PGH) Pair/disconnect key for establishing and disconnecting a Bluetooth connection Bluetooth status indicator (LED) BIOwand status indicator (LED) -
Page 12: Symbols On The Device
Getting Started Symbols on the Device Symbols on the Device Device symbols BIOwand status indicator Bluetooth status indicator Pair/Disconnect button for establishing and disconnecting the Bluetooth connection Power supply connection Programming head connection Type BF applied part Observe the technical manual... -
Page 13: Biowand Status Indicator (Led)
Getting Started BIOwand Status Indicator (LED) BIOwand Status Indicator (LED) The BIOwand status indicator shows the following device statuses: LED behavior and color Device status LED does not indicate any behavior No power received (disabled) LED flashes green Device performing self-test... -
Page 14: Setting Up The Device
Establishing a Connection to the BIOwand App Note The display name of the respective BIOwand is printed on its type plate on the underside of the device. It consists of the product name "BIOwand" and the last three digits of the serial number (e.g., BIOwand678). -
Page 15: Establishing A Connection To A Stimulator
Switch on the device with the Bluetooth interface on which the BIOwand app is installed. Ensure that BIOwand is ready for use. On the device on which the BIOwand app is installed, open the menu to establish a Bluetooth connection. -
Page 16: Error Resolution
Error Resolution Error Resolution When the provided power adapter is connected, the device performs a self-test. If the self-test is not successful, the BIOwand status indicator (LED) lights up orange continuously. The following errors can lead to an unsuccessful self-test: Error... -
Page 17: Appendix
Physical properties Category Design Dimensions (W x D x H) 120 x 150 x 42.8 mm Weight with programming head 230 g Longevity Category Design Longevity 2 years Programming head (BIOwand PGH) Category Design Applied part classification Dimensions (W x D x H) 102 x 132 x 37 mm PGH cable 2.8 m Frequency band 9–315 kHz Operating frequency 32–64 kHz Maximum transmitter field strength <... -
Page 18: Accessories
GFSK, DQPSK, 8DPSK Standard BLE 5.0 Accessories BIOwand is only available as a complete system (device, power adapter, and programming head). 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 according to the "Radiocommunications (Compliance labeling –... -
Page 19: Legend For The Label
• FCC ID: QRI‑BIOWAND Legend for the Label The label icons symbolize the following: Manufacturing date BIOTRONIK order number Serial number Temperature limit for storage Acceptable atmospheric pressure range for storage Acceptable relative humidity range for storage Follow the instructions for use! - Page 20 Device contains materials that must be correctly disposed of in accordance with environ- mental 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. BIOwand Programming head (BIOwand PGH) Signal transmission Neurostimulator from BIOTRONIK...
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