• Designed to keep rectal mucosa and sphincter muscles safe
• Gentle for the patient
• Includes a trauma-free withdrawal mechanism for convenient and safe device removal
• Does not utilize balloon technology and there is less risk of mucosal injury and bleeding as well as less sphincter dysfunction and anal erosion
• Unique and hygienic applicator eliminates the need for digital insertion
• Applicator enables care providers to insert the devices in a precise, accurate, and hygienic manner
• Applicator also prevents potential spread of nosocomial infections and other complications
• Helps to improve efficacy creating exceptional reduction in stool exposure which also leads to less skin irritation
• Can be used on all patients regardless of sphincter tone - three times more patients are eligible for use with the Qora™ Stool Management Kit (SMK) system
• Provides a large lumen and thus accommodates varying stool consistencies.
• Provides end to end malodor protection

Qora™ SMKs are indicated for fecal management by diverting and collecting liquid stool to minimize skin contact in bedridden patients. The device is for use in patients 18 years and older only.

The Qora™ Stool Management Kits should not be used on individuals who:
• Have suspected or confirmed rectal mucosal impairment or pathology, (i.e. severe proctitis, ischemic proctitis, mucosal ulcerations, etc.)
• Have had rectal surgery within the last year
• Have any rectal bleeding or anal injury
• Have hemorrhoids of significant size
• Have a rectal or anal stricture or stenosis
• Have or suspected to have tumor(s) in the rectum or anal canal have or suspected to have impacted stool
• Have or suspected to have constipation
• Have any indwelling rectal or anal device or delivery mechanism in place
• Are known to be sensitive to or allergic to any components within the kit

1. CAUTION: United States federal law restricts this device to sale by or on the order of a physician or other licensed practitioner.
2. The device must be inserted immediately after the patient has passed stool or after the rectum has been confirmed to be evacuated of stool.
3. Do not resterilize. This device is for single use only and should not be re-used. Re-use may lead to increased risk of patient or user infection or cross-contamination. Physical properties of the device may no longer be optimal for intended use.
4. The physician must use their discretion in using the device after having assessed the surgical site and size of hemorrhoid(s).
5. Caution must be exercised in patients with inflammatory bowel condition or a previous history of anorectal surgery.
6. Care should be exercised while inserting the device in patients who have a tendency to bleed from either anticoagulants/antiplatelet therapy or from underlying condition/treatment.
7. Notify a physician immediately if any of the following happens:
• rectal pain
• rectal bleeding
• abdominal discomfort
8. If a patient appears to be having significant anal discomfort or if bleeding is visualized during the insertion of the device, the insertion procedure should be discontinued and the physician should be notified.
9. The diverter can be flushed using the irrigation port or the sheath can be milked to break down or move fecal discharge in case the device lumen gets occluded with fecal material. Repeat the irrigation procedure as often as necessary to maintain proper functioning of the device. If repeated flushing with saline does not return the flow of stool through the transit sheath, the device should be inspected to ascertain that there is no external obstruction (i.e. pressure from a body part, piece of equipment, etc.). If no source of obstruction of the device is detected, use of the device should be discontinued.
10. There is an inherent risk in handling fecal discharge and bodily secretions. Adequate precaution, per hospital guidelines, must be exercised while handling the device.
11. If the patient’s bowel control, consistency, and frequency of stool begins to return to normal/formed stool or the patient becomes ambulatory, discontinue use of the device.
12. Some leakage or fecal discharge may be visible on the periphery of the device on patients with severe diarrhea or if the collection bag is full.
13. As with the use of any rectal device, the following adverse events could occur with the use of this device:
• Rectal or anal bleed
• Constipation or fecal impaction
• Erythema of the rectal mucosa
• Perforation of the anorectal region
• External injury or aggravation if the patient lies on rigid portions of the device
In the event of any adverse events such as those listed above, please notify a physician immediately.
14. If any blood is visible along the periphery of the device or any wet redness of stool is observed in the transit sheath or collection bag, discontinue the use of the device and notify the physician.
15. Ensure that fluid retention clamp is detached from the transit sheath after fluid retention procedure is completed.
16. Qora Aeon™ and Qora Arida™ are not MR safe. Qora AIM™ is MR-conditional. Please consult the product IFU for further information on the use of specific Qora device.

As with the use of any rectal device, the following adverse events could occur with the use of this device:
• Rectal or anal bleed
• Constipation or fecal impaction
• Erythema of the rectal mucosa
• Perforation of the anorectal region
• External injury or aggravation if the patient lies on rigid portions of the device
In the event of any adverse events such as those listed above, please notify a physician immediately.