iMediSync iSyncWave User manual

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Instructions for Use
iSyncWave (ISW-MUS101)
iMediSync Inc.
3F, TIPS TOWN 3, 175, Yeoksam-ro, Gangnam-gu,
Seoul, 06247, Republic of Korea
TEL [phone] FAX [phone]
CAUTION: Federal(USA) law restricts this device to sale by or
on the order of a physician.
Document Number: IMS-W02-IFU
Revision History : Version [0] [ August 20, 2021]
XXXX

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Table of Contents
1. Introduction ............................................................................................................................................ 4
1.1 Company Information...................................................................................................................................................4
1.2 Device Information.........................................................................................................................................................4
1.3. Device Specification......................................................................................................................................................4
1.4 Recommended Tablet Specifications .....................................................................................................................5
2. Device Overview..................................................................................................................................... 5
2.1 How the Device Works.................................................................................................................................................5
2.2 Intended Use..................................................................................................................................................................... 6
2.3 Indication of Use .............................................................................................................................................................6
2.4 Patient-Contacting Components..............................................................................................................................6
2.5 Intended Environment of Use ...................................................................................................................................6
2.6 Intended user profile and environment in usability test..............................................................................7
3. Safety Requirements ............................................................................................................................. 7
3.1 Warnings .............................................................................................................................................................................7
3.2 Precautions......................................................................................................................................................................... 8
3.3 IT Network..........................................................................................................................................................................9
3.4 Explanation of Markings .............................................................................................................................................. 9
4. Device Components............................................................................................................................. 11
4.1 Bottom .............................................................................................................................................................................. 11
4.2 Right................................................................................................................................................................................... 12
4.3 Types of Electrodes ..................................................................................................................................................... 12
5. How to Use the Device ....................................................................................................................... 12
5.1 Charging the Battery .................................................................................................................................................. 11
5.2 Connecting iSyncWave and iSyncWave app ................................................................................................... 13
5.3 Using iSyncWave app................................................................................................................................................. 14
5.3 Putting on iSyncWave and Measuring EEG ..................................................................................................... 32

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5.4 Shutting dow iSyncWave.......................................................................................................................................... 32
5.5 Software Display........................................................................................................................................................... 32
5.6 System message list ................................................................................................................................................. 33
5.6 Installing and Using the Battery ........................................................................................................................... 33
6. Cleaning and Maintenance................................................................................................................. 34
6.1 Outside Surface ............................................................................................................................................................ 34
6.2 Cleaning the Electrodes ............................................................................................................................................ 34
6.3 Maintaining the Electrodes...................................................................................................................................... 35
6.4 Replacing the Electrodes .......................................................................................................................................... 35
6.5 Essential performance................................................................................................................................................ 37
6.6 Maintaining and Storing the Device................................................................................................................... 37
6.7 Transporting the Device............................................................................................................................................ 38
7. Compliance............................................................................................................................................ 39
7.1 Electromagnetic Compatibility-Guidance and manufacturer’s declaration....................................... 39
8. Product Warranty................................................................................................................................. 44
8.1 Troubleshooting............................................................................................................................................................ 44
8.2 Warranty Claim.............................................................................................................................................................. 44
8.3 Warranty Period ............................................................................................................................................................ 45
8.4 Warranty Card................................................................................................................................................................ 46

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1.Introduction
This user manual is intended for reference by iSyncWave users. The manual includes information
about components, instructions for use and safety precautions of iSyncWave. Please read the user
manual before using iSyncWave. We recommend storing the manual in a safe place near the device.
1.1 Company Information
Company Name: iMediSync Inc.
Phone Number: [phone]
Address: 3F, TIPS TOWN 3, 175 Yeoksam-ro, Gangnam-gu
Factory Address: Factory-1, 20, Centum seo-ro, Haeundae-gu, Busan, Republic of Korea
1.2 Device Information
1.3. Device Specification
Product Name
Electroencephalograph (iSyncWave)
Model Name
ISW-MUS101(US),
Intended Use
Acquire electroencephalogram(EEG) and wirelessly transfer data to
tablet
How to Use
Refer to manual
Type of protection
against electric shock
Internally powered ME Equipment
Degree of protection
against electric shock
BF applied part
Degree of harmful
ingress of water
IPX0
Degree of safety in the
presence of flammable
anesthetic mixture with
air, oxygen or nitrous
oxide
Not suitable for use
Weight
1.59kg
Number of Electrodes
19
Reference Electrode
A1
Channel Position
International 10-20 system
Battery
Rechargeable Li-ion
Rated Input Voltage
3.6 V , 2 950 mAh (Li-ion Polymer Battery)
Sampling Rate
250Hz

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1.4 Recommended Tablet Specifications
* It is recommended to use the tablet PC and charger approved by safety test as an electronic
device.
2. Device Overview
2.1 How the Device Works
iSyncWave is a wireless EEG measurement device that applies dry EEG measurement technology
to an international 10-20 system compliant size-adjustable headset.
iSyncWave measures 19 channel EEG and PPG in real time and transfer the data through BLE
wireless connection to the iSyncWave App. The data is displayed and recorded via the iSyncWave
App.
Digital Signal Resolution
24 Bit
Wireless Connection
Bluetooth Low Energy (BLE) v5.0
Accuracy of signal
reproduction
Within 10%
Input dynamic range
+/- 1 mV
maximum offset voltage
+/- 300 mV
Noise
4 μV peak to peak
Frequency range and
bandwidth
0.5 ~50 Hz
Common mode
rejection
89 dB
Description of all
functions
Impedance check, Signal check, EEG recording and review
Description of waveform
displays
Tablet Application (Real time display)
Processor
CPU Speed
2.3 GHz, 1.7 GHz(Octa-Core)
Display
Resolution(Main)
2000 x 1200(WUXGA+)
Memory
RAM Size(GB)
4
ROM Size(GB)
128
Wi-Fi
802.11 a/b/g/n/ac 2.4G+5 GHz, VHT80 MIMO
Bluetooth
Bluetooth v5.0 (LE up to 2 Mbps)
System
Android 8 (Oreo)

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iSyncWave uses dry electrode technology, which doesn’t require a preparation process(e.g.,
applying conductive gel), to obtain high quality EEG signal. This device measures overall EEG data
using 19 EEG electrodes, 1 reference electrode and 1 ground electrode.
With iSyncWave, you can measure both EEG and synchronized PPG data.
EEG is measured from 19 channels using the reference electrode. The measured data can be
digitally converted to common average, longitudinal and transverse montage.
Before measuring the EEG, you can check the impedance of each electrode under the impedance
check screen in the iSyncWave app. EEG amplifier, analog-to-digital converter and Bluetooth are
built in the device. All EEG and PPG signal is sampled at 250Hz and then converted to digital data
at 24-bit resolution.
The user can organize and control iSyncWave during the measurement process with iSyncWave
app. The measured data is automatically saved and can be seen on iSyncWave app.
iSyncWave can be only used by professional and/or medical personnel with product training and
experience in EEG measurement. The professional and/or medical personnel can check the signal
quality in real time and refer to the measured data in clinical practice.
2.2 Intended Use
iSyncWave is intended to be used to acquire EEG, the electrical activity signals of the brain, from
normal individuals and patients(children to adults) with a head circumference between 50cm to
62cm.
2.3 Indication of Use
iSyncWave is to be used to measure electroencephalogram from the scalp of children and
adults. It is not suitable for electro-cerebral inactivity (ECI) determination.
2.4 Patient-Contacting Components
19 EEG electrodes, 1 reference electrode, 1 base electrode and 1 PPG sensor
2.5 Intended Environment of Use
iSyncWave is intended for use in clinical environment.
2.6 Intended user profile and environment in usability test
2.6.1 Intended user environment
1) Conventional environment in hospital

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2.6.2 Intended user profile
At least two individuals (a guide and an evaluator) performed a usability validation evaluation with
a given scenario. A participant should be qualified for User Profile.
1) The users who participate in the validation evaluation shall have a qualification equal to or
higher than the requirement for the user profile.
2) The qualification requirement for the user profile includes:
a) Education:
-. Persons who have completed appropriate training in the product.
-. Healthcare practitioners including doctors.
b) Knowledge:
–. Persons who understand the physical principle of EEG and have received
relevant training.
-. Persons who understand and have been trained in hygiene related to EEG
measurement.
c) Language skill:
–. Persons who understand the content of Instruction for Use written in English.
d) Experience:
–. Persons who have completed appropriate training in iSyncWave.
-. Persons who have completed appropriate training in the EEG analysis
software.
3. Safety Requirements
3.1 Warnings
1. The amplifier shall meet the safety requirements of EN 60601-1, safety class II, and applied
part BF.
2. The manager of the device shall provide a safe environment for a typical EEG system
compliant to EN 60601-1-1 requirements.
3. iSyncWave shall be only operated by an individual who has been designated and has received
safety training.
4. Before handing the electrodes, please carefully read the operation manual provided by the
manufacturer and only use the provided electrodes.
5. Please refer to the user manual for the information of the recommended tablet specifications,
operating system, and the requirements of those settings.
6. Safety precautions for the user and subject to avoid the risk of electrical shock hazard caused
by mechanical shock:
The EEG system shall not be operated if the device is mechanically damaged. The damaged

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device and/or components shall not be used and be requested for repair service. If the
amplifier is damaged, please contact the manufacturer or the service center.
7. Safety precautions to avoid hazards in the event of inadequate hygiene or if the subject
contacts the device contaminated with toxic substance:
If the device’s hygiene is inadequate, clean the device with alcohol. If the device is
contaminated by toxic substance, stop using the device and contact the manufacturer or the
service center.
8. Inadequate EEG recordings or inaccurate interpretation of EEG can be caused by the
following: user’s inadequate ability to operate the device , inaccurate placement of electrodes,
electromagnetic interference, problem with computer device, use of alternative software
and/or operating system not provided by the manufacturer. The User operating the
iSyncWave device shall have adequate knowledge and experience in EEG measurement and
the device.
9. Before wearing the device, please turn on the device for the safety of the patient/subject.
10. Before taking off the device, please turn off the device for the safety of the patient/subject.
11. Do not modify this equipment without authorization of the manufacturer.
12. Do not use the device with HF surgical equipment to protect the patient against burns.
13. Do not use the device with defibrillator.
14. The conductive parts of electrode should not contact other conductive parts including earth.
3.2 Precautions
1. Read all instructions and labels including this manual before starting to use the device system.
2. Do not attach or detach any device components while the device is on to prevent any
damage to the system or components. Turn off the device when attaching or detaching any
components to the device.
3. Do not use acetone or any other cleaning solvents to clean the device.
4. The battery life of the device may be shortened if the device is used frequently and/or for a
prolonged period of time.
5. The battery life of the device is affected by how often you charge and discharge the battery.
6. The battery life and capacity may decrease when the device is stored in a high-temperature
environment.
7. The battery may self-discharge when the device is in storage.
8. Keep the battery charged. If the battery is discharged, it may take a longer time to fully charge.
9. Do not immerse the device into any liquid.
10. Do not expose the device to direct sunlight, heat source of thermal radiation, moisture, vibration,
mechanical shock, excessive dust, or humidity.
11. The warranty will be void if the device is opened, disassembled, or altered by any unauthorized
personnel.
12. Do not use when the device is damaged.
13. Do not use when the device is wet. If any moisture penetrates the device, have the device

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checked by the manufacturer.
14. Do not use caustic or abrasive cleaning agents to clean the device or electrodes.
15. Do not charge when the patient/subject is wearing the device.
16. Always clean the electrodes after each measurement according to the cleaning instructions.
17. For electrode channels that have persistent problems with signal quality, check the wear of the
electrode coating.
18. The battery used in this device may present a fire or chemical burn hazard if mistreated.
To ensure battery safety,
a. Do not detach or disassemble the battery from the device
b. Replace the battery at the service center designated by the manufacturer
19. Do not excessively pull or overstress the device as it may break the device.
20. Do not sit or place a heavy object on the device.
21. Do not use the device under the environment with strong electromagnetic Interference.
3.3 IT Network
The iSyncWave device is connected to the tablet via Bluetooth. Through the tablet the following
can be done:
a. Control and operate the device
b. Check real time and saved EEG data through iSyncWave app
c. Retrieve and review the EEG data in iSyncWave app
3.4 Explanation of Markings
Symbol
Meaning
Follow instructions for use
Stand-by
Follow manual or operating instructions
Keep dry
Keep away from sunlight

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Temperature limit
Humidity limitation
Atmospheric pressure limitation
Separate collection for waste of electrical and electronic equipment.
Medical device
CAUTION: Federal(USA) law restricts this device to sale by or on the order of a
physician.
Manufacturer
Date of manufacture
Model number
Serial number
Unique Device Identifier
CE mark

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Authorized Representative in the European Community
Type BF Applied Part
4. Device Components
4.1 Bottom
The reference electrode connector is at the bottom left side of the device. The PPG sensor and
USB-C connector is at the bottom right side of the device. You can connect the reference
electrode and PPG sensor through the connector. The device can be charged through the USB-C
connector.
Name
Model Name
Description
1
Reference electrode
REF-W01
Ear clip sensor serving as reference point for
EEG measurement

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2
PPG sensor
PPG-W01
Ear clip sensor measuring PPG
3
USB-C charging port
-
Charge lithium-ion battery
4
Power button
-
Turn the device power on and off
5
Electrode
-
Electrodes for EEG measurement
6
Chin strap
-
Secure the device on patient/subject when
using the device
4.2 Right
The power button is at the right side of the device. When the device is turned on or charging, the
LED light on the power button will indicate the status of the device.
<Power Button LED Status>
Status
Color
Description
When turned on
Green
Battery level above 30%
Magenta
Battery level below 30%
When charging
Green
Battery level above 95%
Magenta
Battery level below 95%
When measuring
None
4.3 Types of Electrodes
No.
Name
Description
1
Brush electrode
Ag/AgCl coated conductive polymer (Used except on forehead)
2
Flat electrode
Ag/AgCl coated conductive polymer (Used on the forehead)
5. How to Use the Device
After unpacking from the box, check if the package contains all components; iSyncWave device,
accessories, and user manual.
•Carefully read the user manual and share the documentation if necessary.

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•Check the accessories.
•The products listed in the components are compatible products.
5.1 Charging the Battery
Before using iSyncWave for the first time, fully charge the battery. Fully charging the battery may
take up to three hours. This will help extend the battery life of the device.
•Connect the USB-C charging cable to the charger.
•Plug in the charger to a power outlet.
•Connect the end of the USB-C charging cable to the USB-C charging port of iSyncWave,
which can be found on the bottom right side of the device.
•Place the device on a sturdy flat surface and make sure the bottom side of the device is
facing down.
•If the device is fully charged, the LED status indicator on the power button will be green.
The LED status indicator on the power button will indicate the battery status as follows:
Color
Description
Green
Battery level above 95%
Magenta
Battery level below 95%
5.2 Connecting iSyncWave and iSyncWave app
1. Press the power button and hold for more than 2 seconds to turn on the device
2. Run the iSyncWave app on the tablet
3. Connect your tablet to a Wi-Fi network through the settings panels of your tablet PC
4. Register the patient/subject under the iSyncWave app
5. Connect the iSyncWave device to the tablet via Bluetooth

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5.3 Using iSyncWave app

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