Information for Patients — Vibrant Gastro^™

Vibrant System^™ • For Oral Use • Rx Only

Please talk to your healthcare provider if you have any questions or do not understand any of this information.

What is the Vibrant System^™ and Who should use it?

The Vibrant System^™ is an orally administered Capsule that is indicated for the treatment of adults with chronic idiopathic constipation (see description below) who have not experienced relief of their bowel symptoms by using laxative therapies at the recommended dosage for at least one month.

Chronic idiopathic constipation is a type of constipation associated with:

• Straining,
• Lumpy or hard stools,
• Incomplete evacuation (feeling that all the stool did not come out),
• Feeling like the stool is blocked from leaving the body while trying to use the bathroom,
• 3 or fewer bowel movements per week and requiring manual manipulation (using hands to assist) for defecation in more than 25% of bowel movements.

The Vibrant System^™ includes a reusable Pod, USB cable and AC/DC USB adapter, and single-use Capsules. The Pod is used to activate and calibrate the Vibrant Capsule before swallowing the Capsule. The Vibrant Capsule has small dimensions and a smooth shell to make it easy to swallow. The Capsule is expelled from the body during your regular bowel movements.

1. Pod
2. USB cable
3. AC/DC USB adapter
4. 2 blister packs of 10 Vibrant Capsules each, in 1 box

The Pod

The Pod is used to activate the Vibrant Capsule before swallowing the Capsule.

1. Designated Groove for Capsule
2. Light ring indicator
3. Pod lid

The Capsule should not cause any interference during travel activities such as flying and going through airport security.

Who should not Use the Vibrant System^™?

You should not use the Vibrant System^™ if you:

• Have a history of complicated/obstructive diverticular disease (small sacs in the colon)
• Have a history of, or have suspected, obstruction in your small intestine or colon
• Currently have significant gastroparesis (stomach is unable to empty itself)
• Have a history of significant gastrointestinal disorder, including any form of inflammatory bowel disease or gastrointestinal malignancy (celiac disease is okay if you have been treated and no longer experience signs or symptoms), and/or anal fissures and fistulas
• Have a history of Zenker’s diverticulum, dysphagia, esophageal stricture, eosinophilic esophagitis or achalasia
• Are pregnant or lactating (breastfeeding)

Important Safety Information

Warnings

• ⚠ The Vibrant Capsule is magnetic resonance (MR) unsafe … undergoing an MRI while the Capsule is inside your body may result in injury, including serious damage.
• If you require an MRI, your physician must confirm via abdominal X-ray that no Capsule is in your body before scanning.
• ⚠ After ingesting a Vibrant Capsule and until it has left the body, you should not be near strong electromagnetic fields (e.g., MRI device).
• ⚠ Keep Capsules away from pacemakers, defibrillators, nerve stimulators, and other implants affected by a DC magnetic field.
• ⚠ If you doubt the integrity of a Capsule, do not use it.
• ⚠ Stop and call your physician if you experience: black/bloody stools; abnormal abdominal pain; nausea or vomiting; or if you believe a Capsule has not passed within 2 weeks.
• ⚠ Never swallow a Capsule without activating it in the Pod first.
• ⚠ Keep Capsules out of reach of children. If swallowed, bring child immediately to a hospital.
• ⚠ Avoid using near/stacked with other equipment unless verified for normal operation.
• ⚠ Only use manufacturer-supplied accessories and cables.
• ⚠ Keep portable RF devices at least 30 cm (12 inches) from the Pod.
• ⚠ Inspect Pod & blister packs for tampering before use.
• ⚠ Patients with pelvic floor dyssynergia may struggle to pass Capsules; monitor closely.
• ⚠ Not assessed in patients with chronic NSAID use (>3×/week for 6+ months).

Precautions

• Do not use the Pod or Capsules if packaging is damaged.
• Read this patient label and the instructions for use in their entirety before using.
• A Vibrant Capsule should not be taken after its expiration date.
• Avoid biting the Vibrant Capsule prior to swallowing.
• Long-term use: The safety and effectiveness of the Vibrant System^™ for long-term use has not been evaluated. Long-term use means more than 8 weeks. Therefore, physicians prescribing beyond 8 weeks should re-evaluate the patient, including usefulness of the device.

What are the Expected Benefits and Risks …

The Vibrant System^™ is expected to improve symptoms … pivotal trial showed 40% vs 22% response vs placebo; quality of life 77.9% vs 66.2% … Side effects: abdominal pain, distension, discomfort, nausea, vomiting, blood in stool, diarrhea, flatulence, proctalgia. Rare: obstruction.

Safety beyond 8 weeks has not been evaluated.

How to Use the Vibrant System^™

Setting Up the Pod

1. Connect USB cable to AC/DC adaptor and Pod.
2. Plug into wall outlet. Pod beeps, flashes ~40s, then turns solid blue.
3. Keep Pod powered on ~10 minutes.

Activating and Taking the Capsule

1. Remove one Capsule from blister pack.
2. Remove Pod cover; ensure light ring is solid blue.
3. Place Capsule in groove; light flashes then solid green + beep → Capsule active.

6. Swallow immediately with ~8 oz water. Light returns blue.
7. Replace Pod cover; leave powered ~10 minutes before unplugging.
8. Take up to 5×/week at bedtime: 3 days on, 1 off, 2 on, 1 off.

Storage and Maintenance Instructions

Pod

• Store in dry place, away from sun (not kitchen/bathroom).
• Clean with cloth + 70% isopropyl alcohol before/after each use.
• If disturbed, reset by unplugging/replugging adapter.

Capsules

• Store below 25 °C/77 °F, away from magnets/sunlight.
• Keep in sealed blister until use.
• Observe expiration date.

SYMBOLS

US Office Address: 9600 Great Hills Trail, Suite 150W, Austin, TX 78759
Manufactured by Vibrant LTD, Hakochav Building, 2 Hacarmel St., Yokneam 2069206, Israel

Document: 132LAB Rev 09 • Effective date: Aug 24, 2025

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