Technical Manual

Introduction
About the Device
2
1 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.
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.