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39
frequency
requirements, and
the reduced
sensitivity of
circuits at
microwave
frequencies.
ISO 14117:2019
Clause 6.1 -
Protection of the
device from
damage caused
by high-frequency
surgical exposure Per standard Does not exhibit
malfunction which
persists after the
removal of the
electromagnetic
test signal per
standard Inform your physician or
other qualified health
provider that you are
implanted with an
OPTIMIZER Smart Mini IPG
and that they should consult
the IPG’s Instructions for
Use regarding
Electrocautery and RF
Ablation
ISO 14117:2019
Clause 6.2
Protection of the
device from
damage caused
by external
defibrillators Per standard Does not exhibit
malfunction which
persists after the
removal of the
electromagnetic
test signal per
standard Inform your physician or
other qualified health
provider that you are
implanted with an
OPTIMIZER Smart Mini IPG
and that they should consult
the IPG’s Instructions for
Use regarding
Defibrillation and
Cardioversion
GTRI E3
Representative
Security and
Logistical
Systems
(Electronic article
surveillance,
metal detectors,
RFID) Per E3 protocol Per E3 protocol Seek the advice of your
physician or other qualified
health provider regarding
Store Anti-Theft
Systems/Airport Security
Screening Systems
Electronic Article
Surveillance (EAS)
systems, such as those
found at department stores:
•
Do not linger near an
EAS system longer
than is necessary.
•
Be aware that EAS
systems are often
hidden or
camouflaged near the
exits for businesses
such as retailers.
•
Do not lean against
the system’s sensors.
Metal detector archways:
•
Do not stop or linger