BIOTRONIK BIOwand User manual

BIOwandDevice for wirelesscommunication with theBIOTRONIK stimulatorTechnical Manual452051Revision: C -- DRAFT -- (2021-02-26)

Manufacturer:BIOTRONIK SE & Co. KGWoermannkehre 112359 Berlin / GermanyTel+49 (0) 30 68905-0Fax[phone][email protected]www.biotronik.comDistributor:BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97 035-5369 Tel[phone] (24-hour) Fax[phone] [email protected]© BIOTRONIK SE & Co. KGAll rights reserved. Specifications subject to modification, revision, and Improvement.® All product names in use maybe trademarks or registeredtrademarks held by BIOTRONIK orthe respective owner.

Table of Contents1Table of Contents1Introduction................................................................................................................2About the Device...............................................................................................................................22Safety during Use .......................................................................................................3Warnings...........................................................................................................................................3Precautions.......................................................................................................................................3General Safety Instructions..............................................................................................................3Operating Conditions........................................................................................................................4Electromagnetic Interferences........................................................................................................6Care and Disposal.............................................................................................................................83Getting Started...........................................................................................................9Device Overview ................................................................................................................................9Symbols on the Device......................................................................................................................10BIOwand Status Indicator (LED).......................................................................................................11Power Adapter On/Off Light Indicator (LED)....................................................................................11Bluetooth Status Indicator (LED) .....................................................................................................11Telemetry Status Indicator on the Programming Head..................................................................11Setting up the Device........................................................................................................................12Connecting the Programming Head (BIOwand PGH)......................................................................12Connecting the Power Adapter and Switching on the Device.........................................................12Establishing a Connection to the BIOwand App..............................................................................12Establishing a Connection to a stimulator.......................................................................................13Error Resolution ...............................................................................................................................144Appendix.....................................................................................................................15Technical Data ..................................................................................................................................15Accessories.......................................................................................................................................16Country-related information............................................................................................................16Legend for the Label.........................................................................................................................17

Introduction
About the Device
2
1IntroductionAbout the DeviceGeneral description
BIOwand is used for service support of external and implantable BIOTRONIK stimulators. It enableswireless communication between the stimulator and the BIOwand app. The BIOwand app is operated ona device with a Bluetooth interface, which is used for communication with the BIOwand. Thecommunication with the stimulator takes place via the coil telemetry of the programming head.
Intended use and contraindications
The BIOwand is a medical accessory to the SCS system. It will be used in conjunction with off-the shelfhardware (commercial tablet or laptop) on which application tool for supporting stimulator softwareupdates runs. The intended use of the BIOwand is to enable following points:•Updating the software of the implantable or external stimulator.•As a back-up communication means for recovering software of the implantable or externalstimulator in the rare case that the stimulator state prevents Bluetooth communication.The device is an accessory to the SCSsystem to enable the intended use of the SCSsystem. Medicalindication and contraindication are identical to those of the SCS system.
Required expertise
The use of the device and this technical manual are intended for field representatives of BIOTRONIKwho are familiar with the following topics:•The user has the necessary medical knowledge regarding the stimulation of the spinal cord.•The user was trained in using the device, the BIOwand app, and the programmer for BIOTRONIKstimulators.•The user has access to the technical manuals of the device, the stimulators, and the programmerfor the stimulators.•The user has experience in handling PCs or tablets that are controlled with a touchscreen.Only BIOTRONIK field representatives who have the above-mentioned expertise required for theintended use of the device are permitted to use it.
Patient group
The device is an accessory to the BIOTRONIK stimulators and enables their intended use. The patientgroup is therefore identical to that of the BIOTRONIK stimulators.
Residual risk
The risk analysis carried out by the manufacturer's Risk Management Team has determined that theresidual risk is as low as possible. Prerequisites for this are the intended use of a device that has beenserviced and inspected according to the manufacturer's specifications by BIOTRONIK fieldrepresentatives and the compliance with the safety-relevant instructions in this technical manual.

Safety during Use
Warnings
3
2Safety during UseWarnings
Risk of electromagnetic interference through the use of portable RF communication equipmentIf portable RF communication devices (including peripheral devices such as antenna cables andexternal antennae) are operated closer than 30cm (12inches) from this device, this can result in areduction in its performance. This applies even when using associated cables.•When operating portable RFcommunication devices (including peripheral devices such as antennacables and external antennae), keep such devices at a distance of at least 30cm (12inches) fromthis device.Risk of electromagnetic interference through the use of unauthorized accessoriesThe use of accessories, transducers, or cables not listed by BIOTRONIK or of accessories other thanthose specified by BIOTRONIK, can produce elevated electromagnetic emissions or cause degradationin the device's resistance to electromagnetic interference. Such effects can lead to the faulty operationof the device.•Only use accessories authorized by BIOTRONIK.
Precautions
Risk of electromagnetic interferenceThe use of this device close to or in direct contact with other devices should be avoided, as this maylead to the device operating incorrectly.•Where usage in such a manner is unavoidable, you should monitor this device and all additionaldevices in order to check that they are all working correctly.
General Safety InstructionsTechnical manuals
Technical manuals are either included in hard copy form in the storage package or available in digitalform on the internet: https://manuals.biotronik.com.1.Follow all relevant technical manuals.2.Keep the technical manuals for later use.To ensure safe operation, in addition to this technical manual, please also consult the followingtechnical manuals:•Technical manual for clinical programming of BIOTRONIK external and implantable spinal cordstimulators•Manufacturer information on the MyHomeStream Clinician Programmer•Manufacturer information on the MyHomeStream Patient Programmer•Patient guide for the trial spinal cord stimulation system•Technical manuals for the device on which the BIOwand app is operated

Safety during Use
Operating Conditions
4
Risks of improper handling
Disregarding the safety warnings can endanger the patient, the staff, and the equipment. Failure toobserve the safety warnings voids all damage claims and manufacturer liability. The following dangersmay arise in the event of improper use:•Risk to the patient of receiving ineffective neurostimulator therapy•Personal endangerment due to electrical impact
Changes not permitted
Only the manufacturer BIOTRONIK or a party expressly authorized by the manufacturer may performcorrective maintenance, enhancements, or modifications to the device or its components.
Authorized components
Only use components authorized by BIOTRONIK for your own safety. The use of any other parts voidsthe warranty and eliminates the manufacturer's liability for any consequences.Use the components authorized by BIOTRONIK for the intended purpose as described in this technicalmanual.
Defects
Do not use defective or damaged devices and components.
Liquids
Never connect a damp or wet device to the mains supply and never use damp or wet components.Protect the device and its components from the accidental ingress of liquids and condensation.
Operating ConditionsShipping and storage
If the package is damaged, please contact BIOTRONIK immediately. Do not put the device intooperation.AttentionFunctional impairment due to condensationWhen the device undergoes significant changes in temperature (for example, when transportingthe device or its components from a cold environment to a warm one) condensation can occur onor in the device or its components and permanently damage the electronics.•Allow the device to acclimate to the new ambient conditions. Before powering on the device,wait at least 1 hour to allow condensation to evaporate.
Setup location
CautionRisk of electromagnetic interferenceThe use of this device close to or in direct contact with other devices should be avoided, as this maylead to the device operating incorrectly.•Where usage in such a manner is unavoidable, you should monitor this device and alladditional devices in order to check that they are all working correctly.

Safety during Use
Operating Conditions
5WARNINGRisk of electromagnetic interference through the use of portable RF communication equipmentIf portable RF communication devices (including peripheral devices such as antenna cables andexternal antennae) are operated closer than 30cm (12inches) from this device, this can result in areduction in its performance. This applies even when using associated cables.•When operating portable RFcommunication devices (including peripheral devices such asantenna cables and external antennae), keep such devices at a distance of at least 30cm(12inches) from this device.Only operate the device in rooms that fulfill the following conditions:•No danger of explosion•Suitable for medical purposes•ClassI power outletPlace the device and its components on a flat, dry surface. It should be placed so that it cannot slip,even while the cables are connected. Also ensure that it is protected from liquids and moisture, andthat the patient only comes into contact with the programming head. In addition to this, ensure that thepower plug of the power adapter is easily accessible and can be pulled out of the outlet at all times. Donot touch any plug connections such as Redel connectors and the patient at the same time.
Power supply
The device is operated via the provided power adapter. The electrical outlet must fulfill the followingconditions:•The mains installation at least fulfills the requirements of IEC60364‑7‑710:2002group1.•The power plug of the power adapter goes directly into a permanently installed mains supplyoutlet. No portable multiple socket outlets or extension cables should be used.•The power plug of the power adapter must be easily accessible at all times in order to be able toimmediately disconnect the device from the mains supply.•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.
Cable and plug connections
•Replace the device or its components immediately if there is any visible, even minor damage to thecables.•Lay all cables in such a way that they pose no danger of tripping over them and that any tensileforces that may occur can be safely buffered.•Ensure that the contacts of all connections and plugs are clean. Dirty contacts can lead to signaldistortions.•Ensure that there is no condensation on the plugs or in the connector ports. If condensation ispresent, dry it before use.•Do not force plugs into the connector ports and do not pull on the cable to release the lock whendisconnecting the plugs.

Safety during Use
Electromagnetic Interferences
6
Electromagnetic InterferencesPossible electromagnetic interference
This device is protected from electromagnetic interference and electrostatic discharges in a medicalpractice. At the same time, the emitted interference is reduced to a minimum. The device thus meetsall requirements of IEC60601‑1‑2.The following tests were performed according to IEC60601-1-2:2014:SectionTestTest level7.1EN55011 (CISPR11)Conducted interference emissions•Group1•ClassBEN55011 (CISPR11)Radiated emission7.2.1IEC61000‑3‑2Harmonic distortion (harmonic currentsin the mains supply)•ClassA7.2.2IEC61000‑3‑3Voltage fluctuations and flicker in themains supply8.9IEC61000‑4‑2Electrostatic discharge (ESD)•±8kV contact discharge•±15kV air discharge8.9/8.10IEC61000‑4‑3Electromagnetic fields•Modulation: 1kHz•3V/m, 80MHz – 2.7GHz•Limits for RFcommunicationequipment per Table9 inIEC60601-1-2 (9–28V/m)

Safety during Use
Electromagnetic Interferences
7SectionTestTest level8.9IEC61000‑4‑4Transient conducted surge voltages (EFT,bursts)•±2kV mains supply•±1kV signal lineIEC61000‑4‑5Surge voltage waves on supply lines•±0.5kV, ±1kV line to lineIEC61000‑4‑6Conducted radiofrequency interference•3V•6V in ISMbandsIEC61000‑4‑8AC frequency magnetic fields•30A/m•50HzIEC61000‑4‑11Voltage fluctuations and interruptions insupply voltage•0% UT; 0.5 cyclesAt 0°, 45°, 90°, 135°, 180°, 225°, 270°,315°•0% UT; 1 cycleAt 0°•70% UT; 25 cycles, 30 cyclesAt 0°•0% UT; 250 cycles, 300 cyclesStrong 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 thedevice in certain cases.This kind of device malfunction should be considered as a possible cause if the following is observed:•The device switches on by itself.•The device displays other inexplicable behaviors.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 off and on.If the interference continues, contact BIOTRONIK immediately.WARNINGRisk of electromagnetic interference through the use of unauthorized accessoriesThe use of accessories, transducers, or cables not listed by BIOTRONIK or of accessories otherthan those specified by BIOTRONIK, can produce elevated electromagnetic emissions or causedegradation in the device's resistance to electromagnetic interference. Such effects can lead to thefaulty operation of the device.•Only use accessories authorized by BIOTRONIK.

Safety during Use
Care and Disposal
8CautionRisk of electromagnetic interferenceThe use of this device close to or in direct contact with other devices should be avoided, as this maylead to the device operating incorrectly.•Where usage in such a manner is unavoidable, you should monitor this device and alladditional devices in order to check that they are all working correctly.WARNINGRisk of electromagnetic interference through the use of portable RF communication equipmentIf portable RF communication devices (including peripheral devices such as antenna cables andexternal antennae) are operated closer than 30cm (12inches) from this device, this can result in areduction in its performance. This applies even when using associated cables.•When operating portable RFcommunication devices (including peripheral devices such asantenna cables and external antennae), keep such devices at a distance of at least 30cm(12inches) from this device.
Care and DisposalCleaning and disinfecting
The following regulations are applicable to the device and its components:•Disconnect the power plug from the outlet before cleaning and/or disinfecting.•Use lint-free, soft cloths.•Clean the housing with a damp cloth and mild soap solution.•Disinfect with agents based on alcohol (e.g., AHD2000), on hydrogen peroxide (e.g., Diosol), or onquaternary ammonium compounds (e.g., C.F.40).•Visually inspect the connections: Make sure that the contacts for all connections and cables areclean and free of any type of dirt.
Sterilization
The device, the programming head, and the power adapter cannot be sterilized.
Disposal
The symbol on the type plate, a crossed out garbage can, indicates that the device must be disposed ofin accordance with the Directive 2012/19/EU on waste electrical and electronic equipment (WEEE2).Disposal of this device and its components in an environmentally unfriendly manner will result inenvironmental pollution, as this device and its components contain materials that must be disposed ofin accordance with environmental protection regulations (e.g., WEEE, RoHS, REACH). Return thefollowing devices to BIOTRONIK:•Defective devices•Devices that are no longer used•Devices whose longevity has been exceeded

Getting Started
Device Overview
9
3Getting StartedDevice Overview
Power adapter and programming head1Redel plug of the programming head2Programming head (BIOwand PGH)3Power adapter (FW8000M/12) with on/off light indicator and power plug4Plug for connecting the power adapter to the deviceBIOwand Device5Programming head connection (BIOwand PGH)6Pair/disconnect key for establishing and disconnecting a Bluetooth connection7Bluetooth status indicator (LED)8BIOwand status indicator (LED)9Power supply connection

Getting Started
Symbols on the Device
10
Symbols on the Device
Device symbolsBIOwand status indicatorBluetooth status indicatorPair/Disconnect button for establishing and disconnecting the Bluetooth connectionPower supply connectionProgramming head connectionType BF applied partObserve the technical manualPosition for the guide cam of the Redel plugDevice contains materials that must be correctly disposed of in accordance with environ-mental protection regulations. The European Directive 2012/19/EU on waste electrical andelectronic equipment (WEEE2) applies. Return devices that are no longer used toBIOTRONIK.Follow the instructions for use!CE markSerial numberManufacturing dateRegulatory compliance mark (RCM)Additional symbols of the power adapterApproved for indoor use onlyProtection classII

Getting Started
BIOwand Status Indicator (LED)
11
BIOwand Status Indicator (LED)
The BIOwand status indicator shows the following device statuses:LED behavior and colorDevice statusLED does not indicate any behaviorNo power received (disabled)LED flashes greenDevice performing self-testLED lights up green continuouslyReady for useLED lights up orange continuouslyDevice is not ready for use (an error hasoccurred, see Error Resolution [Page14])
Power Adapter On/Off Light Indicator (LED)
The on/off light indicator of the power adapter shows the following statuses:LED behavior and colorDevice statusLED does not indicate any behaviorDisabledLED lights up green continuouslyReady for use
Bluetooth Status Indicator (LED)
The status indicator for pairing/disconnecting the Bluetooth connection shows the following devicestatuses:LED behavior and colorDevice statusLED does not indicate any behaviorThere is no Bluetooth connectionLED flashes blueA Bluetooth connection to the device is beingestablished (pairing)LED lights up blue continuouslyThere is a Bluetooth connection
Telemetry Status Indicator on the Programming Head
The indicator for the telemetry status is a ring LED directly on the programming head. The ring LEDindicates the following status of the telemetry contact:Ring LED behaviorTelemetry statusRing LED does not indicate anybehaviorThere is no telemetry contact between the programming headand a stimulator.Flashing greenThere is telemetry contact between the programming head and astimulator.Flashing redThe connection to the stimulator is disturbed due to electromag-netic interferences.

Getting Started
Establishing a Connection to the BIOwand App
12
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 onlycome into contact with the programming head. Do not touch any plug connections such as Redelconnectors and the patient at the same time.
Connecting the Programming Head (BIOwand PGH)
The port for the programming head is located on the right rear side of the device. To connect theBIOwand PGH, proceed as follows:1.Insert the Redel plug of the programming head cable into the programming head connector on thedevice. Pay attention to the correct position of the guide cam of the Redel plug. It clicks into place.Connect the programming head so that the cable is resting with some slack in the cable and there is nodanger of tripping.
Connecting the Power Adapter and Switching on the Device
The device switches on automatically as soon as the provided power adapter (FW8000M/12) isconnected. The package contents include various country-specific adapters for the power plug. Theport for the power adapter is located on the left rear side of the device.To connect the power adapter (FW8000M/12) and to switch on the device, proceed as follows:1.Select the appropriate power plug adapter for your region for the enclosed power adapter.2.Insert the required power plug adapter into the power adapter. It clicks into place.3.Connect the power adapter to the outlet.4.Insert the plug of the power adapter cable into the power supply port of the device.The device performs a self-test and the BIOwand status indicator (LED) flashes green. Aftersuccessful self-test, the BIOwand status indicator (LED) lights up green continuously. If the self-test is not successful, the BIOwand status indicator (LED) lights up orange continuously, see ErrorResolution [Page14].Connect the power adapter so that the cable is laid without tensile stress and there is no danger oftripping. Ensure that the power plug is freely accessible at all times.To switch off the device, proceed as follows:1.Disconnect the power plug of the power adapter from the wall outlet.The BIOwand status indicator (LED) of the device turns off.
Establishing a Connection to the BIOwand App
NoteThe display name of the respective BIOwand is printed on its type plate on the underside of thedevice. It consists of the product name "BIOwand" and the last three digits of the serial number(e.g., BIOwand678).The Bluetooth connection must be established manually the first time the BIOwand is used. After theBluetooth connection has been established, BIOwand automatically connects to the device on which theBIOwand app is installed as soon as BIOwand is ready for use.

Getting Started
Establishing a Connection to a stimulator
13To 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 Bluetoothconnection.4.View all available Bluetooth devices.5.Select the desired BIOwand.The display name of the respective BIOwand is printed on its type plate.6.In the menu, select the Connect menu item.The Bluetooth status indicator (LED) on the BIOwand starts flashing blue.7.Within a max. 30s, press the Pair/Disconnect key of the BIOwand to establish the Bluetoothconnection.The Bluetooth status indicator (LED) lights up blue continuously.Disconnecting the BIOwand Bluetooth connectionTo disconnect the Bluetooth connection, proceed as follows:1.Press the Pair/Disconnect key of the BIOwand to disconnect the Bluetooth connection.The Bluetooth status indicator (LED), which lights up blue continuously, turns off.
Establishing a Connection to a stimulator
To establish a connection to a stimulator, proceed as follows:1.Ensure that there is a Bluetooth connection to the device on which the BIOwand app is installed.2.Ensure that the BIOwand app is installed and running.3.Place the programming head on the patient, at the point where the stimulator is implanted or theexternal stimulator is attached.4.Ensure the connection quality between the programming head and the stimulator using thetelemetry status indicator (ring LED) on the PGH, see Telemetry Status Indicator on theProgramming Head [Page11].5.Follow all further instructions and proceed as described in the documentation for the BIOwandapp.

Getting Started
Error Resolution
14
Error Resolution
When the provided power adapter is connected, the device performs a self-test. If the self-test is notsuccessful, the BIOwand status indicator (LED) lights up orange continuously. The following errors canlead to an unsuccessful self-test:ErrorError resolutionNo programming head (BIOwand PGH) isconnected.1.Check whether the programming head(BIOwand PGH) has been correctlyconnected.2.Connect a programming head (BIOwandPGH).An internal error has occurred.1.To switch off the device, pull the plug of thepower adapter out of the device.2.To switch on the device, reinsert the plug ofthe power adapter into the device.The device performs a self-test again. If this self-test is once more unsuccessful and the BIOwandstatus indicator (LED) lights up orange continu-ously, return the device to BIOTRONIK.

Appendix
Technical Data
15
4AppendixTechnical DataGeneral characteristics for the device and the power adapter (configured as an medical electrical system)
CategoryDesignOperating modeContinuous operationTemperature range for operation+10°C ...+33°C/50°F...91°FTemperature range for storage0°C ...+50°C/32°F...122°FRelative humidity20%...75%, no condensationAtmospheric pressure700...1060hPaOperation at altitudesUp to 3,000 mPower supply to the deviceOperation with power adapter (FW8000M/12)
Physical properties
CategoryDesignDimensions (WxDxH)120x150x42.8mmWeight with programming head230g
Longevity
CategoryDesignLongevity2years
Programming head (BIOwand PGH)
CategoryDesignApplied part classificationBFDimensions (WxDxH)102x132x37mmPGH cable2.8mFrequency band9–315kHzOperating frequency32–64kHzMaximum transmitter field strength< -36dBµA/mMax.peak@10mModulationOOKData rateUp to 64kbit/s

Appendix
Country-related information
16
Power adapter (FW8000M/12)
CategoryDesignSupply voltage100–240V, ±10%/ 50–60Hz, 0.3–0.15A/ACProtection classIIMaximum power input12WLevel of efficiency≥ 82.95% (at 115V/60Hz and 230V/50Hz)On/off light indicatorGreen LED, lighted continuously
Bluetooth
CategoryDesignFrequency band2.4GHz ISMBandOperating frequency2400–2483.5MHzNumber of channels40Frequency range2 MHz per channelMaximum power of transmission (EIRP)Class2: 4dBm (2.5mW)ModulationGFSK, DQPSK, 8DPSKStandardBLE5.0
Accessories
BIOwand is only available as a complete system (device, power adapter, and programming head).
Country-related informationInternational radio certification
Telemetry information for Australia: This device is in compliance with the Australian "Radiocommunications Act 1992" and, therefore, itis labeled according to the "Radiocommunications (Compliance labeling – Devices) Notice".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, and2.this device must accept any interference received, including interference that may cause undesiredoperation.Changes or modifications not expressly approved by the party responsible for compliance could void theuser's authority to operate the equipment.

Appendix
Legend for the Label
17NoteThis 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 protectionagainst harmful interference in a residential installation. This equipment generates, uses and canradiate 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 thatinterference will not occur in a particular installation. If this equipment does cause harmfulinterference to radio or television reception, which can be determined by turning the equipment offand on, the user is encouraged to try to correct the interference by one or more of the followingmeasures:•Reorient or relocate the receiving antenna.•Increase the separation between the equipment and receiver.•Connect the equipment into an outlet on a circuit different from that to which the receiver isconnected.•Consult the dealer or an experienced radio/TV technician for help.This device complies with part95 of the FCCRules.This device may not interfere with stations operating in the 400.150– 406.000MHz band in themeteorological aids, meteorological-satellite, and earth exploration-satellite services and must acceptany interference received, including interference that may cause undesired operation.This device will be registered with the Federal Communications Commission under the followingnumber:•FCCID:QRI‑BIOWAND
Legend for the Label
The label icons symbolize the following:Manufacturing dateBIOTRONIK order numberSerial numberTemperature limit for storageAcceptable atmospheric pressure range for storageAcceptable relative humidity range for storageFollow the instructions for use!ContentsDo not use if packaging is damaged

Appendix
Legend for the Label
18CE markCaution: 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 environ-mental protection regulations. The European Directive 2012/19/EU on waste electrical andelectronic equipment (WEEE2) applies. Return devices that are no longer used toBIOTRONIK.BIOwandProgramming head (BIOwand PGH)Signal transmissionNeurostimulator from BIOTRONIK