BIOTRONIK BIOwand Device for Wireless Communication User Manual

BIOTRONIK BIOwand Device for Wireless Communication

Introduction

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.

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. 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 external stimulator 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. Medical indication 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 BIOTRONIK who 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 BIOTRONIK stimulators.
• The user has access to the technical manuals of the device, the stimulators, and the programmer for 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 the intended 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 patient group 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 the residual risk is as low as possible. Prerequisites for this are the intended use of a device that has been serviced and inspected according to the manufacturer’s specifications by BIOTRONIK field representatives and the compliance with the safety-relevant instructions in this technical manual.

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.

• When operating portable RF communication devices (including peripheral devices such as antenna cables and external antennae), keep such devices at a distance of at least 30 cm (12 inches) from this device.

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.

• Only use accessories authorized by BIOTRONIK.

Precautions

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.

General Safety Instructions

Technical manuals
Technical manuals are either included in hard copy form in the storage package or available in digital form 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 following technical manuals:

• Technical manual for clinical programming of BIOTRONIK external and implantable spinal cord stimulators
• 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

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. The following dangers may 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 perform corrective 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 voids the warranty and eliminates the manufacturer’s liability for any consequences.
Use the components authorized by BIOTRONIK for the intended purpose as described in this technical manual.

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 Conditions

Shipping and storage
If the package is damaged, please contact BIOTRONIK immediately. Do not put the device into operation.

Attention
Functional impairment due to condensation
When the device undergoes significant changes in temperature (for example, when transporting the device or its components from a cold environment to a warm one) condensation can occur on or 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

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.

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.

• When operating portable RF communication devices (including peripheral devices such as antenna 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 outlet

Place 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, and that the patient only comes into contact with the programming head. In addition to this, ensure that the power plug of the power adapter is easily accessible and can be pulled out of the outlet at all times. Do not 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 following conditions:

• The mains installation at least fulfills the requirements of IEC 603647710:2002 group 1.
• The power plug of the power adapter goes directly into a permanently installed mains supply outlet. 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 to immediately 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 the cables.
• Lay all cables in such a way that they pose no danger of tripping over them and that any tensile forces that may occur can be safely buffered. · Ensure that the contacts of all connections and plugs are clean. Dirty contacts can lead to signal distortions.
• Ensure that there is no condensation on the plugs or in the connector ports. If condensation is present, dry it before use.
• Do not force plugs into the connector ports and do not pull on the cable to release the lock when disconnecting the plugs.

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 6060112.
The following tests were performed according to IEC 60601-1-2: 2014:

• Group 1
• Class B

 | EN 55011 (CISPR 11)
Radiated emission|
7.2.1| IEC 61000‑3‑2
Harmonic distortion (harmonic currents in the mains supply)|

• Class A

7.2.2| IEC 61000‑3‑3
Voltage fluctuations and flicker in the mains supply|
8.9| IEC 61000‑4‑2
Electrostatic discharge (ESD)|

• ± 8 kV contact discharge
• ±15 kV air discharge

8.9/8.1| IEC 61000‑4‑3
Electromagnetic fields|

• Modulation: 1 kHz
• 3 V/m, 80 MHz – 2.7 GHz
• Limits for RF communication equipment per Table 9 in IEC 60601-1-2 (9 – 28 V/m)

• 2 kV mains supply
• ± 1 kV signal line

IEC 61000‑4‑5
Surge voltage waves on supply lines|

• ± 0.5 kV, ± 1 kV line to line

IEC 61000‑4‑6
Conducted radiofrequency interference|

• 3 V
• 6 V in ISM bands

IEC 61000‑4‑8
AC frequency magnetic fields|

• 30 A/m
• 50 Hz

IEC 61000‑4‑11
Voltage fluctuations and interruptions in supply voltage|

• 0% UT; 0.5 cycles
  At 0°, 45°, 90°, 135°, 180°, 225°, 270°, 315°

• 0% UT; 1 cycle At 0°

• 70% UT; 25 cycles, 30 cycles At 0°

• 0% UT; 250 cycles, 300 cycles

Strong 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 the device 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.

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.

• Only use accessories authorized by BIOTRONIK.

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.

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.

• When operating portable RF communication devices (including peripheral devices such as antenna cables and external antennae), keep such devices at a distance of at least 30 cm (12 inches) from this device.

Care and Disposal

Cleaning 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 on quaternary ammonium compounds (e.g., C.F. 40).
• Visually inspect the connections: Make sure that the contacts for all connections and cables are clean 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 of in 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 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
• Devices that are no longer used
• Devices whose longevity has been exceeded

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 indicator (LED)

9. Power supply connection

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 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.
| Follow the instructions for use!
| CE mark
| Serial number
| Manufacturing date
| Regulatory compliance mark (RCM)

Additional symbols of the power adapter

| Approved for indoor use only
---|---
| Protection class II

BIOwand Status Indicator (LED)

The BIOwand status indicator shows the following device statuses:

occurred, 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:

Bluetooth Status Indicator (LED)

The status indicator for pairing/disconnecting the Bluetooth connection shows the following device statuses:

(pairing)
LED lights up blue continuously| There 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 LED indicates the following status of the telemetry contact

the programming head and a stimulator.
Flashing green| There is telemetry contact between the programming head and a stimulator.
Flashing red| The connection to the stimulator is disturbed due to electromag- netic interferences.

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. Do not touch any plug connections such as Redel connectors 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 the BIOwand PGH, proceed as follows:

1. Insert the Redel plug of the programming head cable into the programming head connector on the device. 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 no danger 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) is connected. The package contents include various country- specific adapters for the power plug. The port 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. After successful self-test, the BIOwand status indicator (LED) lights up green continuously. If the selftest is not successful, the BIOwand status indicator (LED) lights up orange continuously, see Error Resolution [Page 14].

Connect the power adapter so that the cable is laid without tensile stress and there is no danger of tripping. 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

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).

The Bluetooth connection must be established manually the first time the BIOwand is used. After the Bluetooth connection has been established, BIOwand automatically connects to the device on which the BIOwand app is installed as soon as BIOwand is ready for use.

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.
   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 Bluetooth connection.
   The Bluetooth status indicator (LED) lights up blue continuously.

Disconnecting the BIOwand Bluetooth connection

To 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 the external stimulator is attached.
4. Ensure the connection quality between the programming head and the stimulator using the telemetry status indicator (ring LED) on the PGH, see Telemetry Status Indicator on the Programming Head [Page 11].
5. Follow all further instructions and proceed as described in the documentation for the BIOwand app.

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:

1. Check whether the programming head (BIOwand PGH) has been correctly connected.
2. Connect a programming head (BIOwand PGH).

An internal error has occurred.|

1.  To switch off the device, pull the plug of the power adapter out of the device.
2. To switch on the device, reinsert the plug of the power adapter into the device.

The device performs a self-test again. If this self- test is once more unsuccessful and the BIOwand status indicator (LED) lights up orange continu- ously, return the device to BIOTRONIK.

Appendix

Technical Data

General characteristics for the device and the power adapter (configured as an medical electrical system)

Physical properties

Longevity

Programming head (BIOwand PGH)

Power adapter (FW8000M/12)

Bluetooth

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 ­ 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, and
2. this device must accept any interference received, including interference that may cause undesired operation.

Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

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. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• 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 is connected.
• 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 the meteorological aids, meteorological-satellite, and earth exploration-satellite services and must accept any interference received, including interference that may cause undesired operation. This device will be registered with the Federal Communications Commission under the following number:

• FCC ID: QRIBIOWAND

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!
| Contents
| Do not use if packaging is damaged
| 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
| BIOwand
| Programming head (BIOwand PGH)
| Signal transmission
| Neurostimulator from BIOTRONIK

© 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:
BIOTRONIK, Inc.
6024 Jean Road
Lake Oswego,
OR 97 035-5369
Tel (800) 547 ­0394 (24-hour)
Fax (503) 635 ­9936
marketing@biotronikusa.com

Manufacturer:
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

Documents / Resources

| BIOTRONIK BIOwand Device for Wireless Communication [pdf] User Manual
BIOWAND, QRI-BIOWAND, QRIBIOWAND, BIOwand Device for Wireless Communication, Device for Wireless Communication
---|---

References

• BIOTRONIK
• manuals.biotronik.com

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