Impulse Dynamics AIM HIGHer OPTIMIZER, Patient Manual

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frequencies, the
expected
performance of
EMI control
features
implemented to
meet lower
-
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 persi
sts
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
st
andard
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