Electromagnetic Immunity; Electromagnetic Immunity Of The Vesta Charger - Impulse Dynamics OPTIMIZER Smart Mini Patient Manual

APPENDIX I

Electromagnetic Immunity

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 message 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 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
Electrostatic
discharge as
defined in
IEC 61000-4-2
Electrical fast
transient /
burst as
defined in
IEC 61000-4-4
AC line
voltage surges
as defined in
IEC 61000-4-5
Voltage dips,
short
interruptions
and voltage
variations on

Electromagnetic Immunity of the Vesta Charger

IEC 60601-1-
2:2014 test level
Contact
Discharge: ± 8 kV
Air Discharge:
± 2 kV, ± 4 kV,
± 8 kV, and
± 15 kV
± 2 kV for mains
power supply
± 1 kV for in-
/output lines
Line-to-Earth
± 2 kV;
Line-to-Line ± 1 kV
Dips: 100%
reduction for 0.5/1
cycles
30% reduction for
Compliance level
Contact
Discharge: ± 8 kV
Air Discharge:
± 2 kV, ± 4 kV,
± 8 kV, and
± 15 kV
± 2 kV for mains
power supply
± 1 kV for in-
/output lines
Line-to-Earth
± 2 kV;
Line-to-Line ± 1 kV
Dips: 100%
reduction for 0.5/1
cycles
30% reduction for
34
Electromagnetic
environment - guidelines
Floors should be wood,
concrete, or ceramic tile. If
floors are covered with
synthetic material, relative
humidity should be 30% or
greater.
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.
Mains power quality should
be that of a typical home
healthcare, business, or
hospital environment.
Mains power quality should
be that of a typical home
healthcare, business, or
hospital environment.
Note: If the user of the Vesta