Electromagnetic Immunity Of The Guardio Charger - Impulse Dynamics OPTIMIZER Integra CCM-D Patient Manual

Notes:
a
No inappropriate stimulation shall be delivered by the OPTIMIZER Integra CCM-D IPG.
Normal CCM delivery or inhibition of CCM delivery due to interference is permissible, but
inappropriately triggering of CCM delivery by interference is not allowed.
b
The OPTIMIZER Integra CCM-D IPG does not fall within the clear definitions of ISO
14117:2019. As such, the criteria of ISO 14117:2019 were adapted to be applicable to
CCM-D.
c
This guidance shall not be considered the exclusive or only source for this information.
It is best practice to consult the original manufacturer of the item with potential
electromagnetic interference to verify any specific guidance concerning operation and
compatibility with implantable devices. Always seek the advice of your physician or other
qualified health provider with any questions you may have regarding the OPTIMIZER
Integra CCM-D IPG.
d
Electromagnetic fields > 3GHz are not expected to interfere with device operation
because of the increased device protection afforded by the attenuation of the enclosure
and body tissue at microwave frequencies, the expected performance of EMI control
features implemented to meet lower-frequency requirements, and the reduced sensitivity
of circuits at microwave frequencies.

Electromagnetic Immunity of the Guardio Charger

GUIDELINES AND MANUFACTURER'S DECLARATION – ELECTROMAGNETIC
IMMUNITY OF THE GUARDIO CHARGER
Essential Performance of the Guardio Charger:
• The Guardio Charger shall not charge any IPG inappropriately.
• The Guardio Charger shall only charge a paired IPG appropriately.
• The patient shall be made aware of inappropriate charging either by an explicit
message, or by the absence of an expected message from the Guardio Charger.
• If essential performance is lost due to electromagnetic disturbances, the Guardio
Charger shall not be able to charge any IPG.
The Guardio Charger, part of the OPTIMIZER Integra CCM-D System, is intended for use
in an electromagnetic environment as specified below. The customer or user of the
Guardio Charger must ensure that it is used within the specified environment.
The test levels follow FDA recommendations for the home environment per "Design
Considerations for Devices Intended for Home Use - Guidance for Industry and Food and
Drug Administration Staff", November 24, 2014
Immunity test
2:2014 test level
Electrostatic Contact
discharge as Discharge: ± 8 kV
defined in
Air Discharge:
IEC 61000-4-2
± 2 kV, ± 4 kV,
± 8 kV, and ± 15
kV
IEC 60601-1- Compliance level
Contact
Discharge: ± 8 kV
Air Discharge:
± 2 kV, ± 4 kV,
± 8 kV, and ± 15
kV
environment – guidelines
Floors should be wood,
concrete, or ceramic tile. If
floors are covered with
synthetic material, relative
humidity should be 30% or
greater.
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Electromagnetic