Magnetic field strength (at 2 m distance): 16.3 µA/m
Duty cycle: Variable, but low (<5%)
Semi-duplex capability
The radio receiver in the device is using the same frequency and bandwidth as the transmitter.
Cables and transducers:
Cables and transducers are not used during normal use of the device nor while programming the
device.
Quality of Service for Wireless Technology
Bluetooth
®
low energy (BLE) wireless technology enables communication between the generator and
the clinician programmer or patient controller. The requirements for the quality of service (QoS) vary
depending on the use environment (operating room, recovery room, and home environment).
After the clinician programmer or patient controller is paired with a generator, the Bluetooth symbol is
visible on the clinician programmer or patient controller in the upper right-hand corner of the screen.
When the BLE connection is not active, the symbol appears dimmed.
Other requirements include a semi-duplex transmission with a required acknowledge, a transmission
latency in each direction (2x), and a receive-to-transmit mode (RX-to-TX) time. Data is resent if not
sent successfully. Each key press may transmit up to 8 data packets, depending on the number of
packets that need to be transmitted (i.e., if there is only one packet to transmit, only one packet will
be transmitted).
Wireless Security Measures
The wireless signals are secured through device system design that includes the following:
The generator will encrypt its wireless communication.
Only one patient controller or clinician programmer may communicate with the generator at the
same time.
A unique key for each unit that is checked during each transmission.
Built-in pairing that specifies valid and legitimate pairing among units.
Proprietary authentication in addition to the pairing procedure specified in Bluetooth low energy,
which includes an element of proximity.
A proprietary algorithm that detects and prevents an unauthorized user from attempting to pair
with the generator.
Troubleshooting for Wireless and Coexistence Issues
If you experience issues with the wireless communication between the generator and the clinician
programmer or patient controller, try the following:
Decrease the distance between the devices
Move the devices so they share line of sight
Move the devices away from other devices that may be causing interference
Wait a few minutes and try connecting again
Do not operate other wireless devices (i.e., laptop, tablet, mobile phone, or cordless phone) at
the same time
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