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Important Safety Information

To avoid the risk of injury, consider the following warnings and cautions when using Encora X1:

Caution

Though the Encora X1 appears similar to a normal watch or wearable, please keep in mind that this is a sophisticated medical device and should be treated with care.

  • To prevent damage or performance issues with Encora X1, only use the accessories recommended by Encora Therapeutics with the device.

  • This device contains a lithium-polymer battery.

  • The cord on the Charging Station may present a strangulation hazard.

  • Keep away from children and pets.

  • To avoid interfering with diagnostic assessments, do not wear Encora X1 during x-ray examinations.

  • Use with caution in patients with atrial fibrillation, bleeding, or clotting disorders.

  • Consult a doctor about use of this device if you have an implanted device near the proximity of the stimulation site.

  • To prevent Encora X1 Wristband damage, do not pinch, pull, or twist the Wristband with too much force.

  • Should any technical problem occur that is not covered in the Device Guide, please contact Encora Therapeutics at 855-699-5315 or support@encoratherapeutics.com.

Federal law restricts this device to sale by or on the order of a physician.

Warnings

  • To avoid the risk of injury, do not use Encora X1 if you:

    • Do not have healthy, intact skin at the stimulation site. Stimulation from Encora X1 could further irritate your skin.

    • Have peripheral neuropathy, including carpal tunnel syndrome.

    • Are currently pregnant.

  • Use Encora X1 only as directed by the Patient Guide or your physician.

  • Do not open, disassemble, or modify your X1 Stimulator, Wristband, or Charging Station.

  • Keep your Encora X1 system away from devices that could cause electromagnetic interference (EMI).

    • EMI may result in temporary interruption of therapy. Restart therapy by clicking the Main Button once while the device is in Sleep Mode.

Adverse Reactions

The following are minor risks or adverse reactions that you may experience with the use of Encora X1:

  • Skin irritation, including redness or itchiness at the stimulation site

  • Tingling, numbness, or weakness in the hand

  • Possible temporary worsening of tremor

In the unlikely event that any serious reactions occur, stop using Encora X1 and contact your physician.

Things to Avoid

  • Do not open, disassemble, or modify your Encora Stimulator, Wristband, or Charging Station.

  • Do not expose your Stimulator, Wristband, or Charging Station to water.

  • Do not use electronic accessories other than those provided with your Stimulator, Wristband, or Charging Station.

  • Do not use Encora X1 on top of open wounds, rashes, or irritated/ inflamed skin.

  • Do not use the device during charging.

  • Do not place the equipment on, in, or near a heat source. Overheating may damage the device or battery, and may cause the explosion of the device or battery.

Disposal

If you need to dispose of any of your Encora X1 components, follow local disposal regulations.

Note: The Encora X1 Stimulator contains a lithium battery and must not be disposed of in regular household or municipal waste. Please follow local regulations for battery or electronic device disposal.

Potential Device Hazards

  • In the event that Encora X1 emits heat or smoke, remove it from your person immediately.

  • If at any point you feel discomfort when using Encora X1, remove it from your person.

  • Encora X1 should only be used around the wrist.

  • Encora X1 may cause irritation to the skin and soreness around the wrist and upper arm.

  • Effects of Encora X1 have not yet been tested in conjunction with common health concerns.

About The X1

Encora X1 is a non-invasive, wrist-worn neurostimulator that uses personalized mechanical stimulation to provide relief of hand tremors and is designed for use in the home healthcare environment.

Indications for Use

Encora X1 is indicated to aid in the relief of hand tremors in the treated limb during stimulation in adults with essential tremor.

Intended Use

Encora X1 is intended for use and operation by individuals with essential tremor. It is intended for the delivery of mechanical stimulation for hand tremors in essential tremor patients.

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