Impulse Dynamics AIM HIGHer OPTIMIZER, Patient Manual

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Electromagnetic Immunity
Electromagnetic Immunity of the Vesta Charger
GUIDELINES AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC
IMMUNITY OF THE VESTA CHARGER
Essential Performance of the Vesta Charger:
•
The Vesta
Charger shall not charge the OPTIMIZER Smart Mini IPG
inappropriately.
• The patient shall be made aware of inappropriate charging either by an explicit
message, or by the absence of an expected me
ssage from the Vesta Charger
The Vesta
Charger, part of the OPTIMIZER Smart Mini System is intended for use in an
electromagnetic environment as specified below. The customer or user of the
Vesta
Charger must ensure that it is used within the specified en
vironment.
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 IEC 60601-1-
2:2014 test level
Compliance level Electromagnetic
environment - guidelines
Electrostatic
discharge as
defined in
IEC
61000
-4-2
Contact
Discharge: ±
8 kV
Air Discharge:
±
2
kV, ±
4 kV,
±
8
kV, and
±
15 kV
Contact
Discharge: ±
8 kV
Air Discharge:
±
2
kV, ±
4 kV,
±
8
kV, and
±
15 kV
Floors should be wood,
concrete, or ceramic tile. If
floors are covered with
synthetic material, relative
humidity should be 30% or
greater.
Electrical fast
transient /
burst as
defined in
IEC
61000
-4-4
± 2 kV for mains
power supply
± 1 kV for in
-
/output lines
± 2 kV for mains
power supply
± 1 kV for in
-
/output lines
Mains power quality should
be that of a typical home
healthcare, business, or
hospital environment.
Do not operate motors or
other noisy electrical
equipment on the same
mains circuit as the Vesta
Charger.
AC line
voltage surges
as defined in
IEC
61000
-4-5
Line-to-Earth
±
2 kV;
Line-to-
Line ± 1 kV
Line-to-Earth
±
2 kV;
Line-to-
Line ± 1 kV
Mains power quality should
be that of a typical home
healthcare, business, or
hospital environment.
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines as
defined in
Dips: 100%
reduction for 0.5/1
cycles
30% reduction for
25/30 cycles
Interruptions:
100% reduction for
Dips:
100%
reduction for 0.5/1
cycles
30% reduction for
25/30 cycles
Interruptions:
100% reduction for
Mains power quality should
be that of a typical home
healthcare, business, or
hospital environment.
Note: If the user of the Vesta
Charger requires
uninterrupted operation
during power mains