Impulse Dynamics OPTIMIZER Integra CCM-D - Page 44

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ISO 14117:2019
Clause 4.3 -
Protection from
persisting
malfunction
attributable to
ambient
electromagnetic
fields
Per clauses
4.3.2.1, 4.3.2.2,
and 4.3.2.3 of
standard
Does not exhibit
malfunction which
persists after the
removal of the
electromagnetic
test signal per
clauses 4.3.2.1,
4.3.2.2, and
4.3.2.3 of
standard
• Exercise caution in
the vicinity of
equipment that
generates strong
electrical or
electromagnetic
fields.
• Do not enter an area
with posted warnings
advising pacemaker
patients (or patients
with other types of
implantable devices)
not to approach.
• Interference may
occur in the vicinity of
equipment marked
with the following
symbol:
ISO 14117:2019
Clause 4.4 -
Protection from
malfunction
caused by
temporary
exposure to CW
sources
Per standard
Maintains
essential
performance
a
per
standard
ISO 14117:2019
Clause 4.5 -
Protection from
sensing EMI as
cardiac signals
Per clauses 4.5.2,
4.5.3, 4.5.4
Maintains
essential
performance
a
per
clauses 4.5.2,
4.5.3, 4.5.4
ISO 14117:2019
Clause 4.6 -
Protection from
static magnetic
fields of flux
density up to 1
mT
Per standard
Device operation
is unaffected per
standard
Maintain 6 inches (15 cm)
distance between
household magnets or items
containing magnets (e.g.,
headphones, mobile
phones, exercise equipment
containing magnets, etc.)
and implant
ISO 14117:2019
Clause 4.7 -
Protection from
static magnetic
fields of flux
density up to 50
mT
Per standard
Does not exhibit
malfunction which
persists after the
removal from the
field per standard
Seek the advice of your
physician or other qualified
health provider regarding
Magnetic Resonance
(NMR), Magnetic
Resonance Imaging (MRI)