NEUROSTYLE NS-Somnormal-3 User manual

NS-Somnormal-3
Somnormal Microcurrent Stimulator
Operation Manual
COMPANY CONFIDENTIAL V16

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Foreword
Thank you for downloading the manual. This innovative product can
work with terminals like a smart phone or a tablet PC. Through the Internet,
you can upload your treatment data, download your treatment history and
transmit data to another terminal.
This device should work with ‘Somnormal’ App, which works
with Bluetooth 4.0 or above for both Android and IOS system. For Android
system, please upgrade the system to version 4.0 or above. You can download
the App via www.neuro-style.com or by scanning the QR code on the product
package. The App may be upgraded and user interfaces may be adjusted
occasionally to improve the functions, so please check regularly so you do
not miss the updates.
Please read this manual carefully before using this device. You should
follow the operation steps stated in this manual to prevent abnormal operation
results and damage to the device, or even injuries and physical dangers. We
are unable to hold any responsibility for any property damages, injuries or
physical dangers caused by the misuse of this device.
The parameter settings and assessment results from this device are for
reference only. Please consult a professional sleep therapist for the
corresponding recommendations in regards to the parameters and results.

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Content
No.
Subject
Page No.
1
Precautions
Precautionary Notes
Warning
4
4
2
Product Introduction
5
Components
Hardware Instructions
6
Product Specifications
7
App Installation
7
Registration and Binding
8
3
Operation Instructions
9
Hardware Connections
App Use Instructions
9
4
Troubleshooting
14
5
Maintenance
16
6
Transportation and Storage Conditions
17
7
Important Safety Information
17
8
Manufacturer Information
18
9
Power Supply and Battery
18
10
Electromagnetic Compatibility
19
11
After-Sales Service Instructions
20

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1. Precautions
Precautionary Notes:
Environment and Location requirements:
A. Please use the device indoors to ensure the user’s skin temperature is
suitable.
B. Please keep the device away from electrical instruments, high-frequency
radiant point, etc. to avoid interference during treatment.
C. The location should have a special hand-washing station installed for
convenience of use, so that all operating personnel and the users can
wash their hands first before the treatment to release static electricity.
D. Keep the device away from moisture or water, extreme air pressure,
excessive humidity and temperature, poor ventilation and acid gas or
alkaline dust during the treatment.
E. To avoid explosion, do not use this device near flammable anesthetics or
in a hyperbaric oxygen chamber.
Other Notes:
F. Do not use this device for other purposes other than indicated in this
manual.
G. Device parts that are in physical contact with human body after usage
should be well maintained.
H. Voltage and frequency of power supply used for this device must
correspond to the specifications stated in this manual.
Warning:
 Please do not open device casing to avoid any possible shock
hazard. Device maintenance and update should only be done by
service personnel trained or authorized by NeuroStyle Pte Ltd.
 Do not use the device near inflammables like anesthetic to avoid
any risk of explosion.
 Check the device and accessories to ensure device is working
properly before use.
 Do not use device during bath or shower, and do not soak device
in any liquid.
 Please use this device with the ear electrode clips provided

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within the product package.
 This device may temporarily affect the users’physical conditions.
 The safety of using this device during pregnancy or parturition is
not confirmed.
 Keep device away from children.
 Device may become faulty if used with any electronic surgical
device.
 Stimulator output will be unstable when used close (less than 1
meter) to any short wave or microwave treatment device.
 If stimulation is too strong, it may cause headache, vertigo,
nausea and other symptoms.
 Patient with implantable electronic devices (like cardiac
pacemaker) should not use this device.
 Please use the device only with accessories provided by
NeuroStyle Pte Ltd. NeuroStyle Pte Ltd. will not take any
responsibility of any safety problem which is caused by
modification of the electrode cables or other device accessories.
Contraindications
The following groups of people should be advised AGAINST using the
Somnormal:
 Epilepsy patients.
 People implanted with electrical device, for example people
with pacemaker and insulin pump.
 People who are in the midst of driving or operating equipment.
 People who are undergoing treatment for sanguineous apoplexy,
traumatic brain injury or encepha lopathy.
2. Product Introduction
Components:
There are 6 components in this device (refer to the picture below):
1. Power or Bluetooth indicator light 2. Ear clip electrode interface
3. MicroUSB charging port 4. Ear clip electrode cable
5. Felt 6. Charger cable

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HardwareInstructions
A. Activate the device
Insert MicroUSB power cord into ‘MicroUSB charging port’and connect the
other side to the power adapter to charge it fully before treatment. Pair the
device with a terminal like a smart phone or a tablet PC for several seconds to
activate it (refer to App Installation, Registration and Binding below for
detail).
B. Ear clip electrode cable
One end of this cable is a plug to the main device and the other end has two
ear clips. The clips should be used with the felts provided, which should be
soaked in saline solution or pure water for a few seconds before stimulation.
C. Indicator light on the device

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When charging
When device
needs to charge
AfterConnecting
When Working
Red light blinks
1 second during
charging.
Red light blinks 3
times every 10
seconds if power
is less than 20%
when disconnected.
Green light is lit
when device is
connected with a
phone/pad.
Blue light blinks
once stimulation
begins and works
normally.
Green light is lit
when charging is
completed.
Red and Green
light blink alternately
if power is less than
5% when connected.
Indicator light is
off when device
is disconnected
from phone/pad.
Blue light is lit
when the device
is disconnected
to ear clips.
Product Specifications
Product Name:
Model:
Configuration:
Power supply:
Microcurrent Stimulator
NS-Somnormal-3
Software, main unit, ear clip electrode cable, and felts
5V, 500mA
App Installation
This device should work with ‘Somnormal’ App, which is available on both
Android and IOS system.
Before operation, please confirm items below.
A. Download ’Somnormal’App from Google Play Store for smart phone
or pad with Android system，or download ’Somnormal’App from Apple
App Store for smart phone or pad with IOS system. You can also
download the App at www.neuro-style.com or by scanning the QR
code on the product package.
B. Install ’Somnormal’App on your smart phone or pad.
C. Make sure your smart phone or pad can connect to the internet.

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D. Make sure the Bluetooth on your smart phone or pad is activated.
E. Bluetooth 4.0 or above is required. Please upgrade the system if the
blue-tooth version is too low.
Registration and Binding
Register New User Main Interface Bind Device Search Somnormal
For first-time
users, please go
through the user
registration.
Input your email
address at the
registration
Interface. Choose
your birthday and
sex to complete
registration.
After the
registration is
completed, the
main interface
of the App can
then be accessed.
This interface
consists of
[Start], [Assess]
and [Me] tabs.
Switch on the
Bluetooth in
your smart
phone system,
and then press
the top right
button to
open a menu.
Select “Binding"
to enter the
Binding
interface.
At the Binding
interface, press
“Search
Somnormal”
and then select
“Sleep4U :XXX ”
to complete the
device binding.

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3. Operation Instructions
Hardware Connection
1 Place the felts on the
ear clips of the
electrode cable.
Then soak the felts in
saline solution or
pure water for a few
seconds until they
are completely wet.
2 Connect the
ear clip
electrode
cable to the
device
terminal.
3 Place the ear clips on
your ears and begin
stimulation by licking
‘Start’button of the
App on smart phone
or pad which has
been bound to this
device.
App Use Instructions
Start Somnormal
This section is accessed when the App is started.
A. Intensity Control: Press + or - to increase
or decrease stimulation intensity. There
are 12 intensity levels with 50μA intervals.
Adjust the current stimulation intensity
until the stimulation gives a mild tingling
sensation at the earlobes.
B. Mode: Press this to select between the
Treatment Modes “Mode 1”, “Mode 2”
and “Mode 3”.
a) Mode 1 is the Normal mode. A treatment should be conducted
at Mode 1 by default.
b) Mode 2 is the Enhanced Mode. Mode 2 sends stimulation of
stronger intensity than Mode 1, and should only be used if Mode
1 is not effective.

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c) Mode 3 is the "Wake-up" Mode, which delivers the strongest
stimulation among the 3 Modes. If Mode 1 and Mode 2 are not
effective, use Mode 3 for only once, and then use Mode 1 for the
subsequent treatments.
C. Start/Stop: Press the timer circle at the bottom of the interface to begin
treatment. Press again to stop the treatment. Note that the Treatment
Mode can only be changed when there is no ongoing treatment.
Assess
Click on [Assess] tab at the top bar to access this
section (as shown in left).
A. Start Assessment: Press “Go”, and then select
PSQI for insomnia, or select PHQ-9 for
depression, or select GAD-7 for anxiety
assessment. Answer all questions in the
assessments, and the system will provide
sleeping tips based on the assessment results.
B. Recent Assessments: The last 10 sleep quality assessment data is
recorded, and reviewing these data can help to have in-depth
understanding on the user’s sleep quality.
C. Dynamic Map: This is a percentage map that provides a more intuitive
view of sleep quality, based on the result of the last 10 sleep quality
assessment data.

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Review
Click on [Me] tab at the top bar, and then select [Treatment Data] or
[Assessment Data] to enter treatment or assessment data display interface.
Treatment Data
A. Start Date: Check for treatment
data recorded starting from this
date. By default, this date is set
one week before the current
system date. The Start Date
must be set before the End
Date.
B. End Date: Check for treatment
data recorded until this date. By
default, this date is set on the
same day as the current system
date. The End Date must be set
after the Start Date.
C. Data Display: Select the dates to check for treatment data, and the
interface will display treatment data between the dates, including
treatment parameters such as date, intensity and frequency. For easier
review, the daily treatment data are displayed in columns. Please take
note that only the treatment for more than one minute will be recorded.

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Assessment Data
A.
Open the assessment type selection
dialog. Press an option in the dialog to
open the assessment survey page,
which will vary depending on the
assessment type selected.
B. Start Date: Check for treatment data
recorded starting from this date. By
default, this date is set one week before
the current system date. The Start Date
must be set before the End Date.
C. End Date: Check for treatment data recorded until this date. By default,
this date is set on the same day as the current system date. The End Date
must be set after the Start Date.
D. Data display: After selecting the dates, assessment data between the
dates , including assessment date and time, Disorder Index and
assessment result will be displayed. Only the final assessment result of
the day is recorded.

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Other Functions
Unbind Help Personal Information
After choosing ->
Binding, select the
stimulator device in
the main interface
menu, and then
select [Unbind
Stimulator] to enter
the unbind interface.
Press “Unbind”to
unbind the bound
smart device so it
can bind to another
terminal. Press
device power level
to view the current
power status of the
stimulator device.
After choosing ->?
Help, Help menu is
open. This menu lists
out useful information
on the operation of
Somnormal
software, hardware
and consumables, as
well as solutions to
common problems
that may be
encountered
throughout the
device operation.
After clicking Me->My
Information, My
Information page
appears. This page
allows editing of
personal information.
After making the
changes, press the
return arrow at the
top left to close and
save the changes.

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4. Troubleshooting
Problems
Possible reasons
Solutions
Indicator light is
not lit after
connecting with
the smart phone
or pad.
The electrode cable is
not connected
properly, or is
connected to another
stimulator device.
Reconnect the electrode
cable to the connected
stimulator device.
Bluetooth function of
smart device is not
activated.
Activate Bluetooth function
and search for Bluetooth
devices. Please select
‘Somnormal’ to connect.
Indicator light is
faulty.
Contact manufacturer for
repair or replacement.
No current
stimulation pulse
output.
Current intensity is
zero or too low.
Increase current intensity.
Electrode cable
connection with the
terminal is loose.
Reconnect electrode cable,
and make sure the
connection is firm.
Ear clip electrode is
not connected
properly to patient’s
body.
Check the position and
firmness of ear clip
electrodes, whether the felts
on the ear clips are soaked
with saline or pure water.
User’s skin is not
cleaned before using
the device.
Clean the skin with alcohol
or clean water.
Felt is overused, or is
not soaked with
conductive liquid.
Replace the felts and soak
them with saline or pure
water.
The electrode cable is
faulty.
Contact manufacturer for
repair or replacement.

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No current
stimulation pulse
output.
Somnormal device
terminal is faulty.
Contact manufacturer for
repair or replacement.
Blue light stays lit
when ‘Start’is
pressed.
Ear clip electrode
cable is poorly
connected.
Check connection between
electrode cable and device,
and check the position and
firmness of the ear clips,
and check if the felts on the
ear clips are soaked with
saline or pure water.
Device connection
error.
Press ‘Stop’and exit the
app, then restart the App
and rerun the treatment.
Green light stays
lit when ‘Start’is
pressed.
Device connection
error.
Press ‘Stop’and exit the
app, then restart the App
and rerun the treatment.
If you find the device not working normally, please check the power status of
device, Bluetooth connection status and ear clip electrode cable connection
first. Please contact the manufacturer or the nearest after-sales centre at once
if the problem is still not resolved after you have referred and followed the
methods or information suggested in the table above.

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5. Maintenance
Maintenance instructions
This device consists of precision and electronic components. Please follow the
instructions below for a longer product lifespan.
 Avoid collision, humidity, pollution, corrosion, great temperature
difference or long-term insolation.
 Keep device from falling to the ground.
 Keep device away from intense magnetic field and electronic devices
that generate intense magnetic fields.
 Do not clean the hardware surface with water, ethanol, benzene or
other liquid cleaner.
 Please use the device only with accessories provided by the
manufacturer.
 Keep liquids from entering the device to prevent damage to the internal
circuits.
Maintenance methods
 Please confirm that the device has sufficient power if it has not been
used for a long time, and recharge the device first if necessary.
 Please clean the device surface with soft and dry cloth.
 The device should be maintained at least once a year. Device should be
inspected whenever it is necessary, and complete inspection or
calibration should be done by the manufacturer.
 Circuit diagram, table of components and other materials can be only
used by maintenance crews appointed by the manufacturer.
Caution: The warranty clause is only valid when you use parts that are
approved or provided by NeuroStyle Pte Ltd.

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6. Transportation and storage condition
Environmental temperature range: -10℃~ +55℃
Relative humidity range: 15% ~ 90%
Atmospheric pressure range: 960hPa ~ 1060hPa
7. Important Safety Information
Electric shock protection level
BF- Model
Hazard fluid in protection level
IPX0
Protection of defibrillator discharge effect
No
Safety level for use under flammable anesthetic
mixture with air, oxygen or nitrous oxide
Not AP-model, not
APG-model only
Operating method
Continuous operation
System Power Voltage
DC 5V
Disinfection and sterilization methods
recommended by the manufacturer
Applicable
Device Symbols
a). : BF-Type Applied Part
b).
c).
d).
e).
: Please refer to operation manual before use
: Keep dry
: Reusable
: Class II Medical Electrical Equipment (double insulation)

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8. Manufacturer Information
Manufacturer
Company Name
NeuroStyle Pte Ltd
Company Address
63 Hillview Avenue #08-08, Singapore
669569
QMS Certification
ISO13485:2016
Contact Information
Email
[e-mail]
Tel.
[phone]
Fax
[phone]
9. Power Supply & Battery Instructions
Please use power supply equipment as indicated in this manual to the device.
Please make sure power supply voltage matches information on the power
label.
For safe and reliable battery operation, please refer to operation rules below:
A. Actual lifespan of battery depends on frequency of use,
charge-discharge cycle and usage environment.
B. Injury caused by leak or explosion of battery may happen if the battery
is broken apart or burned.
C. Battery should be replaced in the following cases:
 Battery is not working properly, such as the case where the
battery can only work for less than an hour after charging for
hours.
 Battery temperature is unusually high after it is charged or used
in a single treatment course.

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10. Electromagnetic Compatibility
This device has been implemented in accordance to IEC60601-1-2 EMC safety
regulations. However, electromagnetic environment exceeding IEC60601-1-2
specified parameters will seriously interfere with the device and result in the
device not achieving its intended performance levels. Therefore,
electromagnetic effects in the test environment should be avoided, identified
and resolved before using the device.
The following are some common sources of electromagnetic interference and
relevant solutions:
A. Strong electromagnetic interference from radio or mobile phones: This
device and / or system can be installed in other locations. Emission
sources such as mobile phones should stay away from the device and / or
system, or be switched off during examinations.
B. Using AC power for the device and / or system, and radio interference
from other devices:
Confirm the source of interference and if possible, remove the
interference source. Otherwise, please adopt a different power supply.
C. Direct or indirect static electricity influence:
Before use, confirm that all operators and patients contacting the device
do not have direct or indirect static electricity by washing their hands
clean.
D. Interference from radio receivers, such as radio or television:
The device and / or system should be kept away as far as possible from
the radio receivers.
E. Lightning interference:
When lightning occurs near the device and/or system, it will cause
very high voltage surge to the device and / or system.

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In this case, unplug the AC power line from device and / or system, and
use battery power or an uninterruptible power supply to operate the
device and / or systems.
F. Usage with other devices:
When the device and / or system is positioned near or stacked with other
devices, the output of the devices and / or systems may interfere with
each other. Please confirm with the supplier in advance that the devices
and / or systems can be used together safely.
G. Use of non-specified accessories, transducer and/or cable:
If this device and / or system use non-specified accessories, transducer
and / or cables, electromagnetic radiation will increase and reduce
electromagnetic immunity. Electromagnetic requirements of this device
and / or system are consistent with the specified configuration. The
device and / or systems should be used by the specified configuration.
11. After-sales Service Instructions
A. Warranty: One year (for main unit only).
B. Free software upgrade.
C. Please contact manufacturer, Neurostyle Pte Ltd or its appointed
distributor/dealer for further enquiries.