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Intended and Unintended Use

Intended Use

Medical Device Classification

Orisview facilitates the use of other medical devices, meaning it is a medical device that supports achieving the purpose of medical devices.

User

The product must be used only by professional medical personnel who are fully familiar with the manual. Patient population: not specified

Unintended Use

Any use other than those described in the Intended Use section is not allowed.

It is also strictly prohibited:

  • Using the device with charging systems different from the original one supplied with it.
  • Using the device for purposes other than those intended.
  • Modifying the medical device.
  • Using the medical device in unsupported environments.
  • Providing the medical device to untrained users.

NOTE

  • The medical device does not treat any disease nor perform any diagnosis on the patient, being configured as an innovative tool for carrying out the activities indicated in the “description” and “intended use” sections.
  • The medical device may be used by each medical operator for a maximum of 120 consecutive minutes.