INDICATION FOR USE

The Neurolutions Upper Extremity Rehabilitation System is indicated for use in chronic stroke patients (≥ 6 months post stroke) age 18 or older undergoing stroke rehabilitation, to facilitate muscle re-education and for maintaining or increasing range of motion in the upper extremity.

  • Intended Use Environment: The Neurolutions System is designed for use in clinic or home settings as part of prescribed therapy.

CONTRAINDICATIONS

The Neurolutions System is contraindicated for use in patients having any of the following conditions:

  • Severe spasticity or rigid contractures in the wrist and/or digits that would prevent the Neurolutions Handpiece from being properly fit or positioned for use.

  • Skull defects due to craniotomy or craniectomy.

IMPORTANT SAFETY INFORMATION

  • System components contain lithium-ion batteries that MUST NOT be exposed to flame, excessive heat, or incinerated; personal injury may occur.

  • Only use the Charging Adapters provided with the Neurolutions System to recharge system components and avoid risk of shock.

  • Use of the Neurolutions System adjacent to or stacked with other equipment should be avoided because it could result in improper operation.  If such use is necessary, the Neurolutions System and the other equipment should be observed to verify that they are operating normally.

  • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Neurolutions System. Otherwise, degradation of the performance of the Neurolutions System could result.

  • The Neurolutions Handpiece enclosure may reach a maximum temperature up to 43°C during use.  To reduce the risk of discomfort, you should remove the Handpiece from your hand if the device feels warm on your skin.

  • Tight straps on the Handpiece may restrict your circulation. Therefore, always check that the straps are not too tight throughout your range of motion to ensure proper circulation during use.

  • The Neurolutions System should only be used on intact skin, and the System should be cleaned and disinfected regularly to minimize possible contamination and risk of infection.

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