Impulse Dynamics AIM HIGHer OPTIMIZER, Patient Manual

Page: 46 / 66

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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,
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)
•
Exercise caution in
the vicinity of
equipment that
generates strong
magnetic fields.
•
Do not enter an
area with posted
warnings advising
pacemaker patients
(or patients with
other types of
implantab
le
devices) not to
approach.
ISO 14117:2019
Clause 4.8 -
Protection from AC
magnetic field
exposure in the
range of 1 kHz to
140 kHz
Per standard
Does not
exhibit
malfunction
which persists
after the
removal from
the field per
standard
Seek th
e advice of
your
physician or other qualified
health provider regarding
Environmental Conditions ,
Industrial Machinery
, and
Home Appliances .
•
Exercise caution in
the vicinity of
equipment that
generates strong
AC magnetic fields.
•
Do not enter an
area with posted
warnings advising
pacemaker patients
(or patients with
other types of
implantable
devices) not to
approach.