Important Information for RED Patients

Indications For Use

RED is used to evaluate the neuromuscular function of the patient’s ability to expel its contents from the rectum and as a qualitative test for rectal hypersensitivity. RED helps identify patients with rectal hypersensitivity who experience urge-to-defecate at lower volumes of distension. Red is intended to be used in a clinical setting by trained health care providers in adult populations.

510k Number: K242304

About RED

RED was designed to self-inflate to a set volume with a special foam that mimics the “feel” of stool in the rectum. The aim is to provide an efficient, accurate, and cost-effective point of care tool to assess pelvic floor dysfunction and rectal hypersensitivity in patients with chronic constipation.

Precautions

  • Device is designed for single use only. Attempts to reprocess, re-sterilize, and/or re-use may lead to failure of the Device and/or transmission of disease. Immediately dispose of Device after use to avoid re-use.
  • Device is NOT intended to be used with any other biofeedback or manometry equipment.
  • Inspect Device for any evidence of mechanical damage or imperfections before usage. Do not use Device if any damage is noted.
  • Do not use silicone-based lubricant with the Device.
  • Device must be open to ambient for removal. Do not attempt to insert or remove the device in the expanded (inflated) state with the stopcock closed.
  • Do not use beyond expiration date.
  • If you cannot perform a digital rectal exam or if there is pain during the digital rectal exam do not insert the device.
  • Because there are ranges of rectal pressures from 60ml up to as high as 108ml through which hypersensitivity can be identified according to the London Classification tables for Desire to Defecate and this device only tests a volume of 60 cc, there is a risk for false negative such that this device may not diagnose some patients who do have rectal hypersensitivity. Please consider additional testing for patients in whom there is a high suspicion for rectal hypersensitivity.