The iSyncWave device is designed for ease of use with minimal setup, making it an ideal solution for clinicians, psychologists, and brain scanner businesses. Follow these step-by-step instructions to ensure proper use and maximize the device's capabilities.

1. Setup and Preparation

Unboxing and Inspection

1. Carefully unbox the iSyncWave device and accessories, ensuring that all components are included:

   • iSyncWave headset
   • USB-C charging cable and power adapter
   • Disposable dry electrodes (if applicable)
   • User manual and software installation guide

2. Inspect the device for any physical damage and confirm that the battery is charged before use.

2. Device Fitting and Positioning

Headset Placement

1. Measure the patient’s head circumference (between 50 cm and 64 cm) to ensure proper fit.
2. Adjust the headset to fit snugly on the user's head, ensuring optimal electrode contact with the scalp.
3. Position the front electrode (Fpz) at the center of the forehead to ensure accurate signal acquisition.
4. Ensure the dry electrodes are properly aligned and gently pressed against the scalp to establish a good connection.

3. Connecting and Configuring the Device

Powering On and Pairing

1. Press and hold the power button to turn on the device.
2. Enable Bluetooth on your computer, tablet, or mobile device.
3. Open the iSyncBrain software and pair the headset via Bluetooth 5.0/5.1 for data transfer.

Software Setup

1. Launch the iSyncBrain AI platform on your computer or tablet.
2. Create a new patient profile or select an existing one.
3. Choose the assessment type (e.g., cognitive function, stress level, PTSD evaluation).
4. Follow the on-screen prompts to calibrate the device and confirm electrode contact.

4. Conducting an EEG Scan

1. Instruct the patient to sit in a relaxed position with minimal movement.

2. Start the scan via the software interface, which will collect EEG data over a 10-20 minute session.

3. Monitor real-time brainwave data, including:

   • Alpha, beta, delta, and theta wave patterns
   • Heart rate variability (HRV) readings

4. Once the scan is complete, the AI-powered analysis will provide insights, including:

   • Neurocognitive function scores
   • Biomarker detection for mental health conditions
   • Personalized treatment recommendations

5. Administering Photobiomodulation (PBM) Therapy

1. Select the PBM treatment protocol based on the condition (e.g., depression, anxiety, cognitive enhancement).

2. Adjust the near-infrared (NIR) LED settings via the software, selecting:

   • Wavelength: 850 nm (pre-set for optimal penetration)
   • Pulse rate: 1 to 45 Hz (customizable based on patient needs)
   • Duration: Typically 20-30 minutes per session

3. Start the PBM therapy and instruct the patient to remain relaxed during treatment.

4. After the session, review progress reports and adjust future therapy sessions as needed.

6. Post-Session Analysis and Reporting

1. The software automatically generates a detailed report, including:

   • EEG data interpretation with AI-based insights
   • Comparative analysis against normative databases
   • Suggested interventions or follow-up actions

2. Print or digitally share the report with patients for their records.

3. Store data securely within the cloud-based platform for longitudinal tracking.

7. Maintenance and Care

1. Clean the electrodes and device after each use with a soft cloth and alcohol wipes.
2. Charge the device fully before storage to maintain battery health.
3. Regularly check for firmware and software updates to ensure optimal performance.
4. Store the device in a cool, dry place when not in use.

8. Safety and Precautions

• Ensure patients with implanted electronic medical devices (e.g., pacemakers) consult a healthcare provider before use.
• Avoid use in individuals with open scalp wounds or severe skin conditions.
• Adhere to recommended session durations to prevent overexposure to NIR therapy.

By following this guide, clinicians and brain scanner businesses can efficiently utilize iSyncWave to enhance patient care, improve diagnostic accuracy, and deliver effective brain health interventions.

iSyncWave Technical Specifications

General Specifications

• Device Name: iSyncWave
• Weight:
  • Model 1: 1600 g
  • Model 2: 1200 g
• Dimensions:
  • Model 1: 245(L) x 243(W) x 153(H) mm
  • Model 2: 235(L) x 225(W) x 149(H) mm
• Head Circumference Compatibility:
  • Model 1: 50 cm ~ 62 cm
  • Model 2: 41.5 cm ~ 64.2 cm

Electroencephalogram (EEG) System

• Channels:
  • 19 EEG Channels + 1 Fpz Ground Channel
  • Model 1: Right: 1 PPG Channel / Left: A1 Reference Channel
  • Model 2: Fpz Channel: PPG Ground / Right: No Channel / Left: Ref Channel
• EEG Electrode Type: Dry-Type Ag/AgCl-Coated Conductive Polymer
• Bandwidth: 0.5 ~ 50 Hz
• Sampling Rate: 250 Hz
• A/D Converter: 24-bit Analog Front End (AFE)
• Frequency Response: 90% accuracy
• Input Noise:
  • Model 1: < 3 uVp-p
  • Model 2: < 2 uVp-p
• Impedance on Each Channel:
  • Model 1: 300 K
  • Model 2: 200 K
• Pressure on Each Channel:
  • Model 1: 2800 Pa
  • Model 2: 870 Pa

Battery and Charging

• Battery Type: Rechargeable Li-ion Battery
• Charging Interface:
  • Model 1: USB-C Type with 5V/2A Adapter
  • Model 2: USB-C Type with 5V/2.0A, 9V/1.5A Adapter
• Charging Time:
  • Model 1: 132 minutes
  • Model 2: 90 minutes
• Battery Runtime: 7 hours

Connectivity

• Bluetooth Version:
  • Model 1: Bluetooth® v5.0 (LE up to 2 Mbps)
  • Model 2: Bluetooth® v5.1 (LE up to 2 Mbps)

Photobiomodulation (PBM) System

• Irradiance Source: 19 LED Bulbs (Built-in the center of each EEG electrode)
• Wavelength: Near-Infrared 850 nm
• Pulse Rate: 1 ~ 45 Hz (Adjustable in 1Hz increments)
• Optical Power:
  • Model 1: 100 mW/sr
  • Model 2: 140 mW/sr

Regulatory Compliance and Certifications

• Regulatory Status:
  • Registration No.: MFDS(21-5051), FDA(K220056)
  • Medical Device Classification: Class II (Under Process)
• Certifications: ISO 13485:2016 (Quality Management System)

These specifications make the iSyncWave an advanced, portable, and highly effective tool for brain health monitoring and therapeutic applications, providing cutting-edge technology in EEG and PBM therapy.