SLEEP NATURALLY
GET STARTED
USER GUIDE
1
OVERVIEW
ON/OFF
The device is designed
the
shut down
The device
can be
off by pressing the on/off button.
When
indicator
If LED light does not flash, the
battery needs
device is experiencing difficulties.
(See Troubleshooting, pg. 3)
The SomniResonance® SR1 is a precision medical instrument. It is a small, non-invasive, lightweight,
battery-powered device that delivers a weak pulsing electromagnetic signal to induce sleep. The human
brain naturally generates specific electromagnetic frequency patterns that reflect the patient’s state of
consciousness. The process of falling asleep, staying asleep, dreaming and awakening generate their own
specific pattern.
When an individual experiences difficulty falling or staying asleep, usually that means the normal
frequency patterns of the brain are altered. By mimicking the normal frequency patterns of the brain in
the process of falling asleep, the SomniResonance® SR1 gently encourages the brain to fall asleep.
GET TO KNOW YOUR DEVICE
to generate
program for 22 minutes then
automatically.
reactivated or manually shut
OPERATING INSTRUCTIONS: APPLICATION
You will find hypoallergenic, double-sided adhesive patches included
in your package. Attach one side of the patch to the back side of
the device opposite the LED light and the On/Off button. The side
with the adhesive patch is pressed onto your chest over the brachial
plexus, below the middle of the collar bone. Do not place the
device on damaged skin. Incorrect application or operation of the
the device is turned on, the
green light will flash slowly.
to be replaced or the
SomniResonance® SR1 may fail to provide the desired effects. The
green LED light should be on the side of the device away from the skin.
After you have attached the SomniResonance® SR1 and are ready
for sleep, press the On/Off button. Check to see that the device is on and the light is flashing. The
SomniResonance® SR1 will be on for 22 minutes and then automatically turn off. If you wake up during
the night, you can turn it on by pressing the On button again. After 22 minutes it will automatically turn
itself off again.
USER GUIDE
2
SOMNIRESONANCE® SR1 IMPORTANT INFORMATION
The SomniResonance®SR1 device should not be rega rded as a substitute for the attention of your
family doctor or medica l specialist.
• If you discover or suspect that you are pregnant, discontinue using the SomniResonance
SR1 immediately.
• Do not wear the SomniResonance
• If you have a partner fitted with a pacemaker, do not allow the SomniResonance
inches of the pacemaker.
• Do not wear the SomniResonance
• The SomniResonance
• Do not wear the SomniResonance
• Do not wear the SomniResonance
are in use.
• Do not store the SomniResonance
• Do not leave the SomniResonance
moist area such as a bathroom.
ADVERSE EFFECTS
®
SR1 may affect the normal function of sensitive medical electrical equipment.
®
SR1 if you are fitted with a pacemaker or other implanted device.
®
SR1 near a MRI or other sensitive medical equipment such as EEG.
®
SR1 while driving or operating machinery.
®
SR1 in any area where medical diagnostic or treatment devices
®
SR1 on or near a microwave or any electrical/electromagnetic devices.
®
SR1 on or near any heat producing surfaces, or in a wet or
®
®
SR1 within six
Users of the SomniResonance® SR1 may experience lucid dreams and/or an allergic reaction to the
adhesive tape used to hold the device on the skin.
CLEANING
The SomniResonance® SR1 must NOT be immersed in water or other liquids. Do NOT use solvents or
abrasive cleaners to clean the device; wipe using a damp cloth with mild detergent. Apply the liquid
to the cloth and squeeze out surplus liquid. Do not apply liquid to the device directly. Alternatively, an
alcohol wipe may be used for cleansing.
STORAGE
Store the SomniResonance® SR1 in a dry place out of direct sunlight.
MAINTENANCE
The SomniResonance® SR1 is not waterproof and should not be worn in the bath, shower or while
swimming. Do not leave the SomniResonance® SR1 in the bathroom when showering or bathing.
If your SomniResonance® SR1 is immersed in water remove the battery immediately. Allow the
SomniResonance® SR1 to dry (do not use a hair dryer or any other hot object to dry it) and insert a new
USER GUIDE
3
battery. There is a great possibility that getting your SomniResonance® SR1 wet will ruin it. There is no
warranty for devices that have been exposed to moisture.
DISPOSAL
If you ever need to dispose of the SomniResonance® SR1, please follow your local ordinance
requirements. Dispose of button batteries at a hazardous waste collection site. These are considered
hazardous material, and must be taken to a household hazardous waste collection site for
proper disposal.
ADHESIVE DISCS
The SR1 is shipped with 30 adhesive discs. The adhesive discs are Nikstix brand Product No. 8810.
Additional adhesive discs can be purchased from Nikstix directly: 1-877-NIKSTIX (1-877-645-7849) or
www.nikstix.com.
TROUBLESHOOTING
If the green LED light fails to flash when your SomniResonance® SR1 is turned on, the battery needs
to be replaced. The replacement battery should be a CR 2032. To change the battery, locate the two
rectangular openings on the bottom of the device enclosure. Insert a flat screwdriver or similar tool into
the rectangle and gently pry open. Repeat with other side. The top of the device will pop open. Remove
the top to expose the battery. Slide the battery out of the holder, paying careful attention to the side
of the battery with the plus sign (+). Slide in the new battery. Be sure the plus sign (+) is on the same
side as the battery just removed. Turn device ON and ensure that the LED light is activated. If the LED
light does not turn ON, reverse the plus sign (+) and try again. Turn OFF the device, place top back on
enclosure and press until it snaps in place. Be careful to ensure that the switch opening on the top of the
device is aligned with the switch on the circuit board. Battery changing is the only troubleshooting action
the purchaser can perform. If this fails to activate the device, contact the health care professional from
whom you obtained the device for further instructions.
ASSISTANCE
With the exception of changing the battery, nothing in the SomniResonance® SR1 can be serviced by the
owner. For further assistance contact the health care professional from whom you obtained the device.
WARRANTY INFORMATION
The SomniResonance® SR1 is intended to induce sleep in people who have a problem falling asleep or
staying asleep. However, each person is different and individual results may vary. SomniResonance
Biomedical Corp makes no warranties as to the effectiveness on an individual basis. SomniResonance
Biomedical Corp warrants (to the original purchaser only) that the SomniResonance® SR1 will be free
®
®
USER GUIDE
4
of defects in workmanship and materials, under normal use, for a period of one (1) year from the date
of purchase. During the warranty period, SomniResonance® Biomedical Corp will repair or replace the
unit at no charge to the patient at the discretion of the corporation. A copy of the original invoice will
be required by SomniResonance® Biomedical Corp to ensure the device is within the warranty period.
Claims under this warranty are initiated by contacting the health care professional from whom you
obtained the device. This warranty is voided in case of abuse (including exposure to liquids or excessive
moisture), damage to case or circuit board, disassembly, improper battery use, negligence and/or acts
of nature.
USER GUIDE
5
Technical and Safety Information
IEC 60417-5140
This symbol means this is
This symbol means
RF equipment marked with
a Type B Applied Part.
Attention: Consult
Symbol IEC 60417-5140 for
Accompanying Documents
non-ionizing radiation.
(User Instructions)
Emission Test
Compliance
Electromagnetic Environment
The SR 1 uses RF emissions that are very low and are
electronic equipment.
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/flicker
ICE 61000-3-3
RF emissions CISPR 14-1
N/A
N/A
RF emissions CISPR 15
N/A
N/A
Symbols
The SR1 is: Internally Powered Equipment.
A Type B Applied Part Rated for Short Time Operation.
Recommended Operating Conditions
(A) Ambient temperature range of +10 C to +40 C
(B) A relative humidity range of 30% to 75%
(C) An atmospheric pressure range of 700 hPa to 1,060 hPa
Compliance Summary
The SomniResonance Device is a stand-alone technology. It is not part of a medical system. There are
no accessories or connector cables for this device.
The SomniResonance Device may affect the normal function of sensitive medical electrical equipment.
Do not wear the Device in any area where medical diagnostic or treatment devices are in use.
Do not store the SomniResonance Device on or near a microwave or any electrical or electromagnetic
devices. Do not leave the Device on or near any heat producing surfaces or in a wet or moist area such
as a bathroom.
Table 1: Manufacturers Declaration: Electromagnetic Emissions
The SR 1 is intended for use in the electromagnetic environment specified below. The customer or the
user of the SR 1 should assume that it is used in such an environment.
RF emissions CISPR-11
emissions
Group 1
Class B
N/A N/A
N/A
not likely to cause any interference in nearby
N/A
Table 2: Manufacturers Declaration: Electromagnetic Immunity
Immunity Test
Compliance Level
Electrostatic Discharge (ESD)
IEC 6100-4-2
+/- 6 kV contact
+/- 8 kV air
Electrical fast transient/burst
IEC 6100-4-4
+/- 2 kV for power supply lines
+/- 1 kV for input/output lines
Surge
IEC 6100-4-5
+/- 1 kV line(s) to line(s)
+/- 2 kV line(s) to earth
< 5% Ur (>95% dip in Ur for 0.5 cycle)
< 5%
(>95% dip in
for 5 s)
Power frequency (50/60 Hz) magnetic field
IEC 61000-4-5
Immunity Test
IEC 60601 Test Compliance Level
Conducted RF IEC 61000-4-6
3 Vrms 150 kHz to 80 MHz
Radiated RF IEC 61000-4-3
3 Vrms 60 MHz to 2.5 GHz
Rated maximum output
power of transmitter (W)
Separation distance according to frequency of transmitter
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
0.01 W
N/A
0.116 W
0.233 W
0.1 W
N/A
0.368 W
0.737 W
1 W
N/A
1.166 W
2.333 W
10 W
N/A
3.689 W
7.378 W
100 W
N/A
11.667 W
23.333 W
The SR 1 is intended for use in the electromagnetic environment specified below. The customer or the
user of the SR 1 should assume that it is used in such an environment.
Voltage dips, short interruptions and
voltage variations on power supply input
lines
< 40% Ur (>60% dip in Ur for 5 cycle)
< 70% U
(>30% dip in Ur for 25 cycle)
r
U
r
U
r
3 A/m
Table 3: Manufacturers Declaration: Electromagnetic Immunity
The SR 1 is intended for use in the electromagnetic environment specified below. The customer or the
user of the SR 1 should assume that it is used in such an environment.
Table 4: Recommended separation distances between portable and mobile RF
communications equipment and the SR 1.
The SR 1 is intended for use in the electromagnetic environment in which radiated RF disturbances are
controlled. The user of SR 1 can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the SR 1 as
recommended below according to the maximum output power of the communication equipment.
The SomniResonance® technology is based on decades of clinical and academic research.
To learn more about this research please visit the :DSleep website:
www.deltasleeper.com
SomniResonance LLC
P.O. Box 57
Pooler, GA 31322
Loading...