Savi Dual - Guidance and Manufacturers Declaration - Emissions; Guidance and Manufacturers Declaration - Immunity

SAVI Dual™ Migraine Therapy Instructions for Use 24
Guidance and Manufacturer’s Declaration - Emissions
The DWG-0600 is intended for use in the electromagnetic environment of typical homes.
Emissions Test
Compliance
Electromagnetic Environment – Guidance
RF Emissions
CISPR 11
Group 1
The DWG-0600 uses RF energy only for its internal function. Therefore, its RF
emissions are very low and are not likely to cause any interference in nearby
electronic equipment.
RF Emissions
CISPR 11
Class B
The DWG-0600 is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic purposes.
Harmonics
EN 61000-3-2
Class A
Voltage
Fluctuations/Flicker
emissions
Complies
During the immunity testing below, the DWG-0600 (SAVI Dual™) will continue to operate within specification, by delivering a
brief, single pulse of magnetic energy (not above 0.95T) which creates a brief electrical current in the brain intended to stop
or reduce the effects of migraine headaches.
Guidance and Manufacturer’s Declaration – Immunity
The DWG-0600 is intended for use in the electromagnetic environment of typical homes
Immunity Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment – Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±2, 4, 8 and 15 kV air
The relative humidity should be at least 5 %
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±2 kV for power
supply lines
Mains power quality should be that of a
typical home, commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±1 kV differential
mode
Mains power quality should be that of a typical
home, commercial or hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Voltage Dips 30%
reduction, 25/30
periods
At 0°
Voltage Dips 30%
reduction, 25/30
periods
At 0°
Mains power quality should be that of a typical
home, commercial or hospital environment.
If the user of the EQUIPMENT requires continued
operation during power mains interruptions, it is
recommended that the EQUIPMENT be powered
from an uninterruptible power supply or a battery.
Voltage Dips > 95%
reduction, 0.5 period
At 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315°
Voltage Dips > 95%
reduction, 0.5 period
At 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315°
Voltage Dips > 95%
reduction, 1 period
At 0°
Voltage Dips > 95%
reduction, 1 period
At 0°
Voltage Interruptions
> 95% reduction,
250/300 periods
Voltage
Interruptions > 95%
reduction, 250/300
periods
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields from common
appliances in the home are not expected to affect the
device. Power frequency magnetic fields should be at
levels characteristic of a typical location in a typical
commercial or hospital environment. Keep the SAVI
Dual away from sources of high levels of power line
magnetic fields (in excess of 30 A/m) to reduce the
likelihood of interference.”