Given Imaging GIVENIMAGING User Manual Package Insert

Given Imaging Limited Package Insert

Package Insert

\\\DC - 69664/2 - #1258984 v1M2A™ 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™ CapsuleNote: Changes or modifications not expressly approved by Given could void authority tooperate the Given® Imaging Diagnostic System.IntroductionThe M2A™ Capsule is an ingestable imaging capsule, which acquires video images whiletraveling along the patient’s gastrointestinal tract, propelled by natural peristalsis until it isexcreted.The M2A™ Capsule contains a miniscule color video camera with a flash, batteries, atransmitter and an antenna to transmit the acquired images. All of these are encapsulated in a26mm long and 11mm wide ingestable capsule made of biocompatible plastic.IndicationsThe Given® Diagnostic Imaging System is intended for the detection of pathologies as anadjunctive tool in the diagnosis of small bowel gastrointestinal disorders and diseases.The Given® Diagnostic Imaging System may be used in hospitals, outpatient clinics andphysician offices. After the M2A™ Capsule is ingested the patient is not restricted to amedical environment.ContraindicationsThe M2A™ Capsule is contraindicated for use under the following conditions:• In patients suspected to suffer from intestinal obstruction based on the clinical pictureor 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#=O8PGIVENIMAGINGThis device complies with Part 15 of the FCC rules. Operation is subject to the following two conditions: (1) thisdevice may not cause harmful interference, and (2) this device must accept any interference received, includinginterference that may cause undesired operation.!
\\\DC - 69664/2 - #1258984 v1Directions for Use• The physician should give the patient “Patient Instructions for Undergoing CapsuleEndoscopy”, printable from the RAPID™ Application and he/she should verify thatthe patient understands the instructions.• The physician should instruct the patient to fast for 8 hours before the test and formales to shave their abdomen 6 inches above and below the navel on the day of thetest.• When the patient comes to the clinic on the day of the test, the physician shouldproceed according to instructions in the User Manual.• The physician should have the Sensor Array applied to the patient’s abdomen andconnected to the recorder in the Recorder Belt worn around his/her waist.• The physician should take the M2A™ Capsule out of its blister and test it according toinstructions in the User Manual.• If the tests are passed, the physician should instruct the patient to ingest the M2A™Capsule with a sip of water.• If for any reason, after activating the M2A™ Capsule by removing it from its blister,the patient is not taking the M2A™ Capsule, it should be deactivated by replacing it,in its holder, to the blister. The capsule should stop blinking. If it does not stop on thefirst attempt, turn the capsule in its holder and replace in blister until blinking stops.• Under normal conditions, the time elapsed between activating the capsule andingesting it should not exceed 1 minutes.• Before the patient leaves the clinic, the physician should verify that the patient has acopy of “Patient Instructions for Undergoing Capsule Endoscopy” printable from theRAPID™ Application and he/she should verify that the patient understands theinstructions.Warnings• The M2A™ Capsule should be used only after consulting a physician.• A thorough understanding of the technical principles, clinical applications and risksassociated with the M2A™ Capsule is necessary before using this product.• The patient should thoroughly understand how he/she is required to behave duringCapsule Endoscopy.• In patients with strictures of the GI tract, the M2A™ Capsule can potenially causeintestinal obstruction resulting in the need for hospitalization and surgery. The use ofthe M2A™ Capsule in patients with strictures of the GI tract is contraindicated.• If there is reasonable doubt concerning the integrity of the M2A™ Capsule, it shouldnot be used until consulting with an authorized Given® representative and should bedeactivated by returning it in its holder into its blister.• The M2A™ Capsule should not be used after its expiration date.• The M2A™ Capsule is not to be ingested before it has been ascertained by a physicianthat there is no other M2A™ Capsule or other swallowable diagnostic device withinthe patient.• The patient should be instructed to avoid biting the M2A™ Capsule prior toswallowing.
\\\DC - 69664/2 - #1258984 v1• After ingesting the M2A™ Capsule and until it is excreted, the patient should not benear any source of powerful electromagnetic fields such as one created near an MRIdevice.• If after ingesting the M2A™ Capsule the patient has any abdominal pain, nausea orvomiting, he/she should contact the physician immediately.• This M2A™ Capsule must be stored, in a safe place out of the reach of childrenand/or infants.• If contrary to instructions a patient ingested two capsules, he/she should be instructedto contact the physician immediately.• If a child has accidentally swallowed an unused or spent M2A™ Capsule, he shouldbe brought immediately to a hospital.• The M2A™ Capsule should be ingested only in the presence of authorized personnel.The patient should be instructed not to let his/her relatives, neighbors or acquaintancesuse the M2A™ Capsule.• This device has not been tested in pediatric population (children 18 and below) andsafety in young children is unknown.How will the M2A™ Capsule affect the daily routine of the patient?The patient will have to prepare for Capsule Endoscopy in the following manner:• The patient will have to abstain from eating or drinking for 8 hours before undergoingthis test.• The patient may take medication up till two hours before and resume once again twohours after M2A ingestion, with a sip of water.• The patient will have to shave his abdomen 6 inches above and below the navel on theday of the test (for males).• At the physician’s office, a Sensor Array will be put on the patient’s abdomen and willbe connected to a recorder worn on a belt around his/her waist for the duration of thetest. The patient will then be instructed to ingest the M2A™ Capsule.• After ingesting the capsule, the patient will have to abstain from eating or drinking foranother 2 hours. After 2 hours the patient may drink water. Four hours after ingestingthe capsule the patient may have a light snack. After completion of the study thepatient may return to normal diet.• The test will last 8 hours. During the test the patient will have to avoid any physicalactivity that involves sweating. The patient will have to abstain from bending orstooping during the test. The patient must be instructed to never remove the beltduring the test.• At the end of 8 hours, the Sensor Array and Recorder Belt can be removed andreturned as instructed to the physician.• The M2A™ Capsule is disposable and it will be excreted naturally in the patient’sbowel movements.Drug Interactions• The patients may take their usual prescribed medication up till two hours before andresume once again two hours after M2A™ Capsule ingestion, with a sip of water.
\\\DC - 69664/2 - #1258984 v1• If the patient is on any medication that may delay gastric emptying (e.g., calciumchannel blocking agents), it is recommended that the taking of this medication bedelayed till after the capsule endoscopy is complete. This, however, should bediscussed with the patient’s treating physician.Adverse Events• In patients with strictures of the gastrointestinal tract, the M2A™ Capsule canpotentially cause intestinal obstruction resulting in the need for hospitalization andsurgery. The use of the M2A™ Capsule in patients with strictures of thegastrointestinal tract is contraindicated.• Based on the experience gained so far, there is no adverse event related to the properuse of the M2A™ Capsule.Storage• The M2A™ Capsules should be stored in a dry place away from magnetic sources.• To prevent capsule activation, keep the M2A™ Capsules in the blister box until use.• Even if stored in their original containers and according to recommendations, theM2A™ Capsules can be kept for a limited period only. Please note the expiration dateof the capsules.Labeling• Read instructions before use• Single UseGiven Imaging LimitedNew Industrial Park, P.O.Box 258 Yoqneam,20692 ISRAELwww.givenimaging.com!2

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