Medtronic 97725 Declarations

Electromagnetic Compatibility Declaration

(EN 60601-1-2)

for the Model 97745 Controller, Model 97755 Recharger,
and Model 97725 Wireless External Neurostimulator

Reference manual

Medtronic® is a trademark of Medtronic, Inc., registered in the U.S. and other countries.

The BLUETOOTH
SIG, Inc. and any use of such marks by Medtronic is under license.

®

word mark and logos are registered trademarks owned by Bluetooth

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Wireless quality of service

Near-field magnetic induction communication

Near-field magnetic induction communication, operating at 175 kHz, is used between the
Medtronic neuromodulation external instruments and implantable neurostimulators.
Successful programming or recharging requires close proximity between the programmer
and the neurostimulator, limited to a maximum distance of approximately 9 cm
(approximately 3.54 inches).

Medical Implant Communications Service (MICS)

Medical Implant Communications Service (MICS) is a wireless radio band operating at
402 to 405 MHz. It is used for communication between Medtronic neuromodulation
external instruments and implantable neurostimulators. MICS has a range of
approximately 2 meters (approximately 6.5 feet).

®

BLUETOOTH

BLUETOOTH

2.4 to 2.4835 GHz ISM band and using wide band modulation techniques — is used
between the Medtronic neuromodulation external instruments and external
neurostimulators. Medtronic's use of the protocol uses forward error correction (FEC) on
data packets, frequency hopping spread spectrum (FHSS), which aids in spectral co­existence, and a very reliable data stream profile. Interrupted or partial messages are
invalid and must be resent. If communication errors are detected, the system will
automatically retransmit the interrupted message to guarantee delivery of the message. If
the wireless connection does not automatically re-establish itself, the user should
reposition the external instrument to re-establish communication.

wireless technology

®

wireless technology — a wideband transmission system operating in the

Wireless security

Near-field magnetic induction communication

A model-specific device access code is used to initiate a programming session. The
near-field magnetic induction communication link between an external instrument and an
implantable neurostimulator is limited to a maximum distance of approximately 9 cm
(approximately 3.54 inches). Inadvertent programming, malicious programming, and
eavesdropping are mitigated by close contact with the patient. No information is
exchanged using recharge energy, therefore no security risks exist.

Medical Implant Communications Service (MICS)

A model-specific device access code is used to initiate a programming session.
Additionally, the MICS link between an external instrument and an implantable
neurostimulator is encrypted using an AES128 encryption method. Inadvertent
programming, malicious programming, and eavesdropping are mitigated by close contact
with the patient that is required to initiate a session and encryption. If the telemetry
connection is lost without warning, the user should reposition the programmer to re­establish the connection. Interrupted or partial messages are invalid and must be resent.

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