Impulse Dynamics OPTIMIZER Lite System Patient Manual page 45

ISO 14117:2019
Clause 6.1 -
Protection of the
device from
damage caused
by high-frequency
surgical exposure
ISO 14117:2019
Clause 6.2
Protection of the
device from
damage caused
by external
defibrillators
GTRI E3
Representative
Security and
Logistical
Systems
(Electronic article
surveillance,
metal detectors,
RFID)
frequency
requirements, and
the reduced
sensitivity of
circuits at
microwave
frequencies.
Per standard
Per standard
Per E3 protocol
Does not exhibit
malfunction which
persists after the
removal of the
electromagnetic
test signal per
standard
Does not exhibit
malfunction which
persists after the
removal of the
electromagnetic
test signal per
standard
Per E3 protocol
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Inform your physician or
other qualified health
provider that you are
implanted with an
OPTIMIZER Lite IPG and
that they should consult the
IPG's Instructions for Use
regarding Electrocautery
and RF Ablation
Inform your physician or
other qualified health
provider that you are
implanted with an
OPTIMIZER Lite IPG and
that they should consult the
IPG's Instructions for Use
regarding Defibrillation
and Cardioversion
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
in a walk-through
archway; simply walk