Impulse Dynamics OPTIMIZER Integra CCM-D - Page 46

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ISO 14117:2019
Clause 5 -
Testing above
frequency of 3000
MHz
Standard does
not require testing
of devices above
3 GHz
e
N/A
Avoid direct exposure to the
main lobe of high-power
radar and microwave
communication beams.
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
persists 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 Integra CCM-D
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
standard
Inform your physician or
other qualified health
provider that you are
implanted with an
OPTIMIZER Integra CCM-D
IPG and that they should
consult the IPG’s
Instructions for Use
regarding Defibrillation
and Cardioversion