Impulse Dynamics OPTIMIZER Smart Mini Patient Manual page 46

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)
frequencies, the
expected
performance of
EMI control
features
implemented to
meet lower-
frequency
requirements,
and the reduced
sensitivity of
circuits at
microwave
frequencies.
Per standard Does not
exhibit
malfunction
which persists
after the
removal of the
electromagnetic
test signal per
standard
Per standard Does not
exhibit
malfunction
which persists
after the
removal of the
electromagnetic
test signal per
standard
Per E3 protocol Per E3 protocol Seek the advice of your
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
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
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:
40

Do not linger near
an EAS system
longer than is
necessary.

Be aware that EAS
systems are often
hidden or
camouflaged near