iMediSync iSyncWave - Device Usage Details; Intended Use and Indications; Patient-Contacting Components and Environment; User Profile and Usability Testing

Precautions
1. 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 ordetaching any components to the device.
2. Do not use acetone or any other cleaning solvents to clean the device
3. Keep the battery charged. If the battery is discharged,
it may take a longer time to fully charge the device.
4. Do not immerse the device into any liquid.
5. Do not expose the device to direct sunlight, near the source
of thermal radiation, moisture, vibration, mechanical shock,
excessive dust, or humidity
6. Do not use when the device is wet, if any moisture penetrates
the device, have the device checked by the iMediSync representative.
7. Do not use caustic or abrasive cleaning agents to clean
the device or electrodes.
8. Do not charge when the patient/subject is equipped - wearing the device.
9. Do not excessively pull or overstress the device as it may break the device.
10. Do not sit or place a heavy object on the device.
11. Do not use the device in an environment with strong
electromagnetic interference.
Safety
• The device and the other features shall not be operated if the device is mechanically
damaged to avoid any risk of electrical shock
• The battery used in this device may present a re or chemical burn hazard if mismanaged.
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 iMediSync or the representative.
• The damaged device and/or components shall not be used and be requested for repair service.
If the amplier is damaged, please contact the iMediSync Customer Support at
https://www.imedisync.com/en/supports/customer-support/
• Safety precautions to avoid hazards in the vent of inadequate hygiene or
if the subject contacts the device contaminated with a toxic substance,
stop using the device and contact the iMediSync Customer Support.
• Turn on the device for the safety of the user/subject before wearing it.
• Turn off the device for the safety of the user/subject before wearing it.
• Do not use the device with HF surgical equipment to protect the patient against burns.
• Do not use the device with a debrillator
• The conductive parts of the electrode should not contact the other conductive
partsincluding the earth.