Impulse Dynamics AIM HIGHer OPTIMIZER, Руководство для пациента

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Electromagnetic Immunity of the OPTIMIZER Smart
Mini IPG
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 en
vironment 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 cardi
ac 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
ISO 14117:2019
Clause 4.2 –
Induced lead current
–
16.6 Hz to 20 kHz
Test 1 an
d Test
2 per standard
Induced lead
current does
not exceed
limits for Test 1
and Test 2 per
standard
Seek the advice of your
physician or other qualified
health provider regarding
Environmental Conditions
•
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