BIOwand Device for wireless communication with the BIOTRONIK stimulator Technical Manual 452051 Revision: C -- DRAFT -- (2021-02-26)
© 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. Distributor: Manufacturer: BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97 035-5369 Tel (800) 547 –0394 (24-hour) Fax (503) 635 –9936 marketing@biotronikusa.com BIOTRONIK SE & Co.
1 Table of Contents Table of Contents 1 2 3 4 Introduction ................................................................................................................ 2 About the Device ............................................................................................................................... 2 Safety during Use ....................................................................................................... 3 Warnings ...............................................
2 1 Introduction About the Device Introduction About the Device General description BIOwand is used for service support of external and implantable BIOTRONIK stimulators. It enables wireless communication between the stimulator and the BIOwand app. The BIOwand app is operated on a device with a Bluetooth interface, which is used for communication with the BIOwand. The communication with the stimulator takes place via the coil telemetry of the programming head.
3 2 Safety during Use Warnings Safety during Use Warnings 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.
4 Safety during Use Operating Conditions Risks of improper handling Disregarding the safety warnings can endanger the patient, the staff, and the equipment. Failure to observe the safety warnings voids all damage claims and manufacturer liability.
5 Safety during Use Operating Conditions 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.
6 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. The following tests were performed according to IEC 60601-1-2: 2014: Section Test Test level 7.
7 Safety during Use Electromagnetic Interferences Section Test Test level 8.9 IEC 61000‑4‑4 • ± 2 kV mains supply Transient conducted surge voltages (EFT, bursts) • ± 1 kV signal line IEC 61000‑4‑5 • ± 0.5 kV, ± 1 kV line to line IEC 61000‑4‑6 • 3V Conducted radiofrequency interference • 6 V in ISM bands IEC 61000‑4‑8 • 30 A/m AC frequency magnetic fields • 50 Hz IEC 61000‑4‑11 • 0% UT; 0.
8 Safety during Use Care and Disposal 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 all additional devices in order to check that they are all working correctly.
9 3 Getting Started Device Overview Getting Started Device Overview Power adapter and programming head 1 Redel plug of the programming head 2 Programming head (BIOwand PGH) 3 Power adapter (FW8000M/12) with on/off light indicator and power plug 4 Plug for connecting the power adapter to the device BIOwand Device 5 Programming head connection (BIOwand PGH) 6 Pair/disconnect key for establishing and disconnecting a Bluetooth connection 7 Bluetooth status indicator (LED) 8 BIOwand status i
10 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 Position for the guide cam of the Redel plug Device contains materials that must be correctly disposed of in accordance with environmental protection regulations.
11 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 LED lights up green continuously Ready for use LED lights up orange continuously Device is not ready for use (an error has occurred, see Error Resolution [Page 14]) Power Adapter On/Off Light Indicator (LED
12 Getting Started Establishing a Connection to the BIOwand App Setting up the Device To set up the BIOwand, proceed as follows: 1. Place the device and its components on a flat, dry surface. 2. Make sure that the device and its components are protected against liquids and moisture. 3. Make sure that the device cannot shift, even with the cable connected, and that the patient can only come into contact with the programming head.
13 Getting Started Establishing a Connection to a stimulator To establish a Bluetooth connection to the BIOwand app for the first time, proceed as follows: 1. Switch on the device with the Bluetooth interface on which the BIOwand app is installed. 2. Ensure that BIOwand is ready for use. 3. On the device on which the BIOwand app is installed, open the menu to establish a Bluetooth connection. 4. View all available Bluetooth devices. 5. Select the desired BIOwand.
14 Getting Started 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 Error resolution No programming head (BIOwand PGH) is connected. 1. Check whether the programming head (BIOwand PGH) has been correctly connected. 2. Connect a programming head (BIOwand PGH). 1.
15 4 Appendix Technical Data Appendix Technical Data General characteristics for the device and the power adapter (configured as an medical electrical system) Category Design Operating mode Continuous operation Temperature range for operation +10°C ... +33°C / 50°F ... 91°F Temperature range for storage 0°C ... +50°C / 32°F ... 122°F Relative humidity 20% ... 75%, no condensation Atmospheric pressure 700 ...
16 Appendix Country-related information Power adapter (FW8000M/12) Category Design Supply voltage 100–240 V, ± 10% / 50–60 Hz, 0.3–0.15 A / AC Protection class II Maximum power input 12 W Level of efficiency ≥ 82.95% (at 115 V/60 Hz and 230 V/50 Hz) On/off light indicator Green LED, lighted continuously Category Design Frequency band 2.4 GHz ISM Band Operating frequency 2400–2483.
17 Appendix Legend for the Label 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 equipment 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.
18 Appendix Legend for the Label CE mark Caution: Federal law (USA) restricts this device to sale by or on the order of physician. 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.
