Important Safety Information

Opening Statement

"ZeraFlow is an investigational medical device. It is not cleared or approved by the U.S. Food and Drug

Administration (FDA) for commercial use in the United States. ZeraFlow is currently undergoing the FDA 510(k)

clearance process. Use outside of clinical evaluation settings requires regulatory authorization."

Side Effects

The following side effects were observed in a published peer-reviewed clinical study of 125 consecutive patients (Ziv Y,

Scapa E. Techniques in Coloproctology. 2013;17:39-44):

- Mild transient nausea: 1.6% incidence (n=2 of 125 patients)

- Abdominal pain or cramping: 0% incidence

- Temporary sensation of abdominal fullness during the procedure, immediately resolved by the system's active

drainage function

Note: Additional side effect data is under review. This page will be updated as further clinical information becomes

available.

Contraindications

ZeraFlow is not appropriate for patients with any of the following conditions. Patients presenting with these conditions

must use alternative bowel preparation methods. Confirm eligibility with your treating physician before scheduling a

ZeraFlow prep.

- Active severe Inflammatory Bowel Disease (IBD) or acute diverticulitis

- Known or suspected bowel obstruction or gastrointestinal perforation

- Severe or uncompensated heart failure or renal insufficiency

Note: This contraindications list is pending final confirmation from Clark Hill LLP. Do not publish this page until Clark Hill

sign-off is confirmed.

Citation

Ziv Y, Scapa E. Techniques in Coloproctology. 2013;17:39-44. https://link.springer.com/article/10.1007/s10151-012-0876-8