Use Instructions

36
Electromagnetic Immunity
GUIDELINES AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY OF
THE OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR
The OPTIMIZER Smart Mini IPG, part of the OPTIMIZER Smart Mini System is intended for use in an
electromagnetic environment as specified below. The patient implanted with the OPTIMIZER Smart
Mini IPG must ensure that it is used within the specified environment.
Essential Performance of the OPTIMIZER Smart Mini IPG:
The IPG shall be able to operate with safe settings. It is allowable that these settings disable CCM
stimulation.
a
NOTE: In case of emergency, placing a pacemaker magnet over the implant site of the OPTIMIZER
Smart Mini IPG and maintaining it in close proximity to the device for at least two cardiac cycles (2–3
seconds), sets the OPTIMIZER Smart Mini IPG into Magnet Mode, suspending CCM therapy.
Immunity test
b
Test level
Compliance
level
Electromagnetic environment –
guidelines
c, d
ISO 14117:2019
Clause 4.2 – Induced
lead current – 16.6 Hz
to 20 kHz
Test 1 and Test 2
per standard
Induced lead
current does not
exceed limits for
Test 1 and Test 2
per standard
See section on Cautions →
Environmental Conditions in this
manual.
• 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 4.3 - 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
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
See section on Warnings →
Nuclear Magnetic Resonance
(NMR), Magnetic Resonance
Imaging (MRI) in this manual