Given Imaging GIVENIMAGING User Manual Revisions

Given Imaging Limited Revisions

User Manual Revisions

March 29, 2001Joe DichosoOffice of Engineering and Technology LaboratoryFederal Communications Commission7435 Oakland Mills RdColumbia MD 21046-1609Re: Given ImagingApplication EA99991Corres. Ref. # 18593Dear Mr. Dichoso:Following are revisions to the User’s Manual submitted as an exhibit tothe above-referenced application. These revisions are provided in response to thecorrespondence reference number above.The changes deal with the instruction to the physician regarding the briefperiod of time between when the physician takes the M2A Capsule out of itspackaging and the Capsule being ingested by the patient. These changes reflectour conversation on this subject in response to the correspondence referred toabove, and this letter serves as our response to this aspect of your correspondence,as well as our confirmation that the revisions shown on the following pages will beimplemented in Given’s User’s Manuals and other future documentation, if any,where similar language or instruction appears.Please contact either Michele Farquhar or me with any questions orfurther requests for information or revisions. Thank you.SincerelyRonnie LondonCounsel for Given ImagingAttachments
OverviewGiven Imaging Ltd. 4The M2A™ Capsule starts immediately after its removalfrom the proximity of the magnet in the blister and theconsequent closing of the magnetic switch in the capsule.After a brief (less than one minute) test by the physician toverify that the capsule is active, the capsule is ingested by thepatient.In order to minimize the potential for radiofrequencyinterference from the device after removing it from theblister package and until it is ingested by the patient, theM2A™ capsule should be tested as quickly as possible.After verification that the M2A™ capsule is operational –it should be immediately ingested by the patient.While active, the capsule transmits images at a rate of 2images per second. For each image, an illuminating lightflash of 100ms is applied with the illuminating LEDs. Whenthe battery power is depleted, the transmitter disables theimager and switches the M2A™ Capsule off.For specification and technical parameters of the M2A™Capsule, refer to System Specifications on page 15. ForIndications and Contraindications, refer to Indications andContraindications on page 9.
Capsule EndoscopyGiven Imaging Ltd. 85The Data Recorder LED starts blinking green.5. Instruct the patient to take the M2A™ Capsule out of itsholder.6. Ask the patient to put the M2A™ Capsule in his/hermouth, and to hold it under the tongue WITHOUTINGESTING.7. If after a short adjustment period, with the M2A™Capsule in the patient’s mouth, the green light keeps onblinking, ask the patient to ingest the capsule with a sipof water.Note:The time elapsed between capsule activation andingestion should usually not exceed 1 minutes.Inorder to minimize the potential forradiofrequency interference fromthe device after removing it fromthe blister package and until it isingested by the patient, the M2A™capsule should be tested as quicklyas possible. After verificationthat the M2A™ capsule isoperational – it should beimmediately ingested by thepatient.8. In the Event Form, write down the ingestion time of theM2A™ Capsule.

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