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M2A™ Capsule (CAP2A)

Package Insert

! Caution: US Federal Law restricts this device to sale by or on the order of a physician.

Read this package insert in its entirety before using the M2A™ Capsule

Note: Changes or modifications not expressly approved by Given could void authority to

operate the Given® Imaging Diagnostic System.

Introduction

The M2A™ Capsule is an ingestable imaging capsule, which acquires video images while

traveling along the patient’s gastrointestinal tract, propelled by natural peristalsis until it is

excreted.

The M2A™ Capsule contains a miniscule color video camera with a flash, batteries, a

transmitter and an antenna to transmit the acquired images. All of these are encapsulated in a

26mm long and 11mm wide ingestable capsule made of biocompatible plastic.

Indications

The Given® Diagnostic Imaging System is intended for the detection of pathologies as an

adjunctive tool in the diagnosis of small bowel gastrointestinal disorders and diseases.

The Given® Diagnostic Imaging System may be used in hospitals, outpatient clinics and

physician offices. After the M2A™ Capsule is ingested the patient is not restricted to a

medical environment.

Contraindications

The M2A™ Capsule is contraindicated for use under the following conditions:

• In patients suspected to suffer from intestinal obstruction based on the clinical picture

or pre-procedure testing and profile.

• In patients with cardiac pacemakers or other implanted electromedical devices.

• During pregnancy

• With patients who have known or suspected gastrointestinal obstruction or strictures.

Prior abdominal surgery is a relative contraindication to the use of the M2A™

Capsule.

ID#=O8PGIVENIMAGING

This device complies with Part 15 of the FCC rules. Operation is subject to the following two conditions: (1) this

device may not cause harmful interference, and (2) this device must accept any interference received, including

interference that may cause undesired operation.

Summary of content (4 pages)

PAGE 1
M2A™ Capsule (CAP2A) Package Insert ID#=O8PGIVENIMAGING This device complies with Part 15 of the FCC rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. ! Caution: US Federal Law restricts this device to sale by or on the order of a physician.
PAGE 2
Directions for Use • • • • • • • • • The physician should give the patient “Patient Instructions for Undergoing Capsule Endoscopy”, printable from the RAPID™ Application and he/she should verify that the patient understands the instructions. The physician should instruct the patient to fast for 8 hours before the test and for males to shave their abdomen 6 inches above and below the navel on the day of the test.
PAGE 3
• • • • • • • After ingesting the M2A™ Capsule and until it is excreted, the patient should not be near any source of powerful electromagnetic fields such as one created near an MRI device. If after ingesting the M2A™ Capsule the patient has any abdominal pain, nausea or vomiting, he/she should contact the physician immediately. This M2A™ Capsule must be stored, in a safe place out of the reach of children and/or infants.
PAGE 4
• If the patient is on any medication that may delay gastric emptying (e.g., calcium channel blocking agents), it is recommended that the taking of this medication be delayed till after the capsule endoscopy is complete. This, however, should be discussed with the patient’s treating physician. Adverse Events • • In patients with strictures of the gastrointestinal tract, the M2A™ Capsule can potentially cause intestinal obstruction resulting in the need for hospitalization and surgery.