XXXX Instructions for Use iSyncWave (ISW-MUS101) iMediSync Inc. 3F, TIPS TOWN 3, 175, Yeoksam-ro, Gangnam-gu, Seoul, 06247, Republic of Korea TEL +82 2-747-7422 FAX +82 2-745-7422 CAUTION: Federal(USA) law restricts this device to sale by or on the order of a physician.
Table of Contents 1. Introduction ............................................................................................................................................ 4 1.1 Company Information ................................................................................................................................................... 4 1.2 Device Information ..........................................................................................................................................
5.4 Shutting dow iSyncWave .......................................................................................................................................... 32 5.5 Software Display ........................................................................................................................................................... 32 5.6 System message list ...........................................................................................................................................
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.
Digital Signal Resolution 24 Bit Wireless Connection Bluetooth Low Energy (BLE) v5.0 Accuracy of signal Within 10% reproduction Input dynamic range +/- 1 mV maximum offset voltage +/- 300 mV Noise 4 μV peak to peak Frequency range and 0.5 ~50 Hz bandwidth Common mode 89 dB rejection Description of all Impedance check, Signal check, EEG recording and review functions Description of waveform Tablet Application (Real time display) displays 1.
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.
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. -.
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.
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.
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.
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.
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.
• 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.
5.
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5.4 Putting on iSyncWave and Measuring EEG 1) Find a comfortable environment and position to measure EEG. 2) Go to the Settings page and set the measurement time. 3) Put on the iSyncWave device on patient/subject’s head so that the electrodes are in good contact with the scalp. Put on the chin strap to secure the device. 4) Check for the electrode impedance on the iSyncWave app. 5) After checking the electrode impedance, start measuring EEG. 5.
5.7 System message list No 1 Popup Message Causes of Popup The remaining battery is low. When the battery charging Please restart after recharging of iSyncWave(HardWare) the device. is less than 10% Required Action A user is recommended to charge the iSyncWave hardware before use of the device A user is recommended 2 The connection with When bluetooth connection to bluetooth connect iSyncWave has been lost.
4. Disposal instructions To protect the environment, always follow the local law, rules, and policies of disposal instruction of electronics and batteries. USA: Lithium-ion batteries are classified by the federal government as non-hazardous waste and are safe for disposal in the normal municipal waste stream. These batteries, however, do contain recyclable materials and are accepted for recycling by Call2Recycle, Inc. Please go to their website at www.call2recycle.org for additional information.
wipe the surface of the electrode. 3. Always clean and dry the electrodes after each measurement for the subsequent user. 6.3 Maintaining the Electrodes 1. If there is a channel with persistent signal quality problem, check the wear of the electrode. 2. Avoid excessively bending or applying force to the electrode bristles as it may cause wear, shortening the electrode lifetime. 6.
6.4.1 Removing the Electrodes 1. Put a flat-head screwdriver between the 2. Push the screwdriver until the electrode is electrode and the metal holder and push lifted. upwards. 3. Slightly pull the electrode with your hands. 6.4.2 Installing the Electrodes 1. Place the electrode on the metal holder. 2. Push the electrode down using the provided pusher.
6.5 Essential Performance Test Name Test Method Measurement of the degree of Accuracy of signal reproduction reproduction after inputting a signal in the range of ±0.5 mV that changes at a speed up to 12 mV/s. Test Criteria Test Period Reproduced within 20% error or +/- 10uV as a Once a year larger value. When a DC offset voltage within the ±300 mV range and a differential input signal voltage of Dynamic input range and differential offset ±0.
and high humidity. • Storage/Transport Temperature: -50 ℃ ~ 50℃ • Storage/Transport Humidity: 25% ~ 95% (Noncondensing) • Storage/Transport Atmospheric pressure: 700hPa ~ 1060hPa • Operating Temperature: 10 ℃ ~ 40℃ • Operating Humidity: 30% ~ 85% (Noncondensing) • Operating Atmospheric pressure: 700hPa ~ 1060hPa 6.7 Transporting the Device 1. Turn off the device when transporting the device. 2. When transporting the device long distance, make sure to pack the device in a shock proof packing.
7. Compliance 7.1 Electromagnetic Compatibility-Guidance and manufacturer’s declaration Guidance and manufacturer’s declaration – electromagnetic emissions The ISW-MKR101 is intended for use in the electromagnetic environment specified below. The customer or the user of the ISW-MKR101 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance The ISW-MKR101 uses RF energy only for its internal RF emissions CISPR 11 Group 1 function.
Guidance and manufacturer’s declaration – electromagnetic immunity The XD2000 PX is intended for use in the electromagnetic environment specified below. The customer or the user of the XD2000 PX should assure that it is used in such an environment. IMMUNITY test IEC 60601 test level Compliance level Electromagnetic environment - guidance Floors should be wood, Electrostatic discharge (ESD) IEC 61000-4-2 concrete or ceramic tile.
Guidance and manufacturer’s declaration – electromagnetic immunity The ISW-MKR101 is intended for use in the electromagnetic environment specified below. The customer or the user of the ISW-MKR101 should assure that it is used in such an environment.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
Recommended separation distances between portable and mobile RF communications equipment and the XD2000 PX The ISW-MKR101 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
8. Product Warranty 8.1 Troubleshooting Issue App login error Bluetooth connection error EEG measurement error PPG measurement error Wear of electrode Ag/AgCl coating Increased charging time of battery Decreased device run time Solution Check Wi-Fi Settings Restart the device and try again. If the error persists, contact the service center. Restart the device and try again. If the error persists, contact the service center. Reconnect the PPG sensor to the connector.
by the manufacturer 8. Service fee may apply for services irrelevant to product defects(e.g., product training, irregular inspection, Bluetooth or Wi-Fi connection problem due to external environment, cleaning the insides of the device, defect due to using third-party products and/or software) regardless of the warranty period. ※ Repair and service may be denied in any of the following cases 1. Unable to perform repair or provide service due to the user’s intention and negligence 2.
8.4 Warranty Card Warranty Card Product Name: Model Number: Serial Number: Date of Purchase: Place of Purchase: Warranty Period: 1 year from date of purchase Client Name: Organization: Phone Number: This is to certify that this device has passed the strict quality control and comprehensive inspection.
FCC Compliance Statement This device complies with part 15 of the FCC rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. FCC Interference Statement This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules.
