iMediSync iSyncWave Instructions For Use Manual
  1. Manuals
  2. Brands
  3. iMediSync Manuals
  4. Medical Equipment
  5. iSyncWave
  6. Instructions for use manual

iMediSync iSyncWave Instructions For Use Manual

Hide thumbs Also See for iSyncWave:
Table of Contents

Advertisement

Quick Links

Download this manual
Instructions for Use
Document Number: IMS-W02-IFU
Revision History : Version [0] [ August 20, 2021]
iSyncWave (
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.
)
ISW-MUS101
XXXX
Page 1 of 46

Advertisement

Table of Contents
loading

Related Manuals for iMediSync iSyncWave

Summary of Contents for iMediSync iSyncWave

  • Page 1 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.

  • Page 2: Table Of Contents

    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 Page 2 of 46...
  • Page 3 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............................

  • Page 4: 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.

  • Page 5: Recommended Tablet Specifications

    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.

  • Page 6: Intended Use

    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.

  • Page 7: Intended User Profile And Environment In Usability Test

    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.

  • Page 8: Precautions

    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.

  • Page 9: Network

    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: Control and operate the device b.
  • Page 10 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...

  • Page 11: Device Components

    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.

  • Page 12: Right

    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.

  • Page 13: Charging The Battery

    • 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.

  • Page 14: Using Isyncwave App

    5.3 Using iSyncWave app Page 14 of 46...
  • Page 15 Page 15 of 46...
  • Page 16 Page 16 of 46...
  • Page 17 Page 17 of 46...
  • Page 18 Page 18 of 46...
  • Page 19 Page 19 of 46...
  • Page 20 Page 20 of 46...
  • Page 21 Page 21 of 46...
  • Page 22 Page 22 of 46...
  • Page 23 Page 23 of 46...
  • Page 24 Page 24 of 46...
  • Page 25 Page 25 of 46...
  • Page 26 Page 26 of 46...
  • Page 27 Page 27 of 46...
  • Page 28 Page 28 of 46...
  • Page 29 Page 29 of 46...
  • Page 30 Page 30 of 46...
  • Page 31 Page 31 of 46...

  • Page 32: Putting On Isyncwave And Measuring 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.

  • Page 33: System Message List

    Do you wish to reconnect? with a tablet is lost a tablet on the iSyncWave You have failed to upload. A user is recommended When upload of the Please try again after...

  • Page 34: Cleaning And Maintenance

    Association (http://www.epbaeurope.net/legislation_national.html). 6. Cleaning and Maintenance The device shall be cleaned and disinfected as the electrodes and inner surfaces of iSyncWave come in contact the skin and hair. Before cleaning, make sure the power of the device is turned off. If the power is on, hold the power button for 2 seconds to turn off the device.

  • Page 35: Maintaining The Electrodes

    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.
  • Page 36 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 2.

  • Page 37: Essential Performance

    6.5 Essential Performance Test Name Test Method Test Criteria Test Period Measurement of the degree of Reproduced reproduction after inputting a within 20% error Accuracy of signal signal in the range of ±0.5 mV Once a year or +/- 10uV as a reproduction that changes at a speed up to 12 larger value.

  • Page 38: Transporting The Device

    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 •...

  • Page 39: Compliance

    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...
  • Page 40 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. IEC 60601 Electromagnetic environment IMMUNITY test Compliance level...
  • Page 41 Electromagnetic environment - guidance test level level Portable and mobile RF communications equipment should be used no closer to any part of the iSyncWave, including cables, than the recommended separation distance Conducted RF 3 Vrms 3 V rms calculated from the equation applicable to...
  • Page 42 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. 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.
  • Page 43 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. The customer or the user of the ISW-MKR101 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ISW-MKR101 as recommended below, according to the maximum output power of the communications equipment.

  • Page 44: Product Warranty

    8. Product Warranty 8.1 Troubleshooting Issue Solution App login error Check Wi-Fi Settings Restart the device and try again. Bluetooth connection error If the error persists, contact the service center. Restart the device and try again. EEG measurement error If the error persists, contact the service center. Reconnect the PPG sensor to the connector.

  • Page 45: Warranty Period

    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.

  • Page 46: Warranty Card

    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.
  • Page 47 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.

This manual is also suitable for:

Isw-mus101

Table of Contents