Given Imaging GIVENIMAGING User Manual Patient Instructions

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Document ID	135689
Application ID	pWKvLsQKPWU+Cxc10xQrOw==
Document Description	Patient Instructions
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Microsoft Word - pdf
Filesize	3.77kB (47105 bits)
Date Submitted	2001-02-07 00:00:00
Date Available	2001-03-30 00:00:00
Creation Date	2001-02-07 22:36:47
Producing Software	Acrobat Distiller 4.0 for Windows
Document Lastmod	2001-02-07 22:36:49
Document Title	Patient Instructions

Patient Instructions for Undergoing Capsule Endoscopy
Your doctor has determined that as part of your medical evaluation you should undergo a test
known as Capsule Endoscopy. This procedure involves ingesting a small (the size of a large
vitamin pill) Given® Imaging M2A™ Capsule which will pass naturally through your digestive
system while taking pictures of the intestine. The images are transmitted to a sensor array which
is placed on your abdomen. These sensors are attached to the walkman-like Given® Data
Recorder that is worn around your waist, which will will save all the images. After 8 hours the
Given® Data Recorder will be taken off and returned to your physician for processing. In order
for your physician to get the most accurate information from this test, you will need to follow the
directions listed below:
1.
Do not eat or drink for 8 hours prior to undergoing your Capsule Endoscopy.
2.
For males: On the day prior to the Capsule Endoscopy, shave your abdomen 6 inches above and below
the navel. If it is difficult for you to shave your abdomen, please contact your physician’s office to
arrange to come in earlier to have this done.
3.
Please arrive at your physician’s office at the prescribed time for your Capsule Endoscopy.
4.
At your physician’s office, the Sensor Array will be applied to your abdomen with adhesive pads and will
be connected to the Given® Data Recorder which is worn on a belt around your waist. You will then be
instructed to ingest the M2A™ Capsule.
5.
After ingesting the M2A™ Capsule, do not eat or drink for 2 hours. After 2 hours you may drink water.
After four hours you may have a light snack. After completion of the study, you may return to your
normal diet. Contact your physician immediately if you have any abdominal pain, nausea or
vomiting anytime after ingesting the M2A™ Capsule.
6.
After ingesting the M2A™ Capsule and until it is excreted, you should not be near any source of
powerful electromagnetic fields such as one created near an MRI device.
7.
The Capsule Endoscopy will last 8 hours. During the Capsule Endoscopy try to avoid any strenuous
physical activity. Do not bend or stoop during the Capsule Endoscopy. You must also not remove the
belt at any time during this period.
8.
Every 15 minutes during the Capsule Endoscopy you will need to verify that the small green/blue light
on top of the recorder is blinking. If for some reason it stops, please record the time and contact your
physician. Also record the time and the nature of any event such as eating, drinking and unusual
sensations. Return these notes to your physician at the time you return the equipment.
9.
At the end of 8 hours, the Given® Data Recorder, Belt, and Sensor Array can be removed and returned
as instructed by your physician. To remove the Sensor Array and Given® Data Recorder Belt, first
disconnect the Sensor Array from the Given® Data Recorder, then remove the Belt with the Given®
Data Recorder and Given® Recorder Battery Pack in it. Disconnect the Given® Recorder Battery Pack
from the Given® Data Recorder and then put them in a safe place. After removing the Belt, peel the
Adhesive Sleeves off your abdomen without removing them from the sensors and place the Sensor
Array with the rest of the equipment. Do not pull the wires of the Sensors to assist in removing the
Sensors from your abdomen! After removal, leave the sensors in the Adhesive Sleeves. They will be
removed at your physician’s office.
10. The Given® Data Recorder holds the images of your examination. Handle the Given® Data Recorder,
Belt, Sensor Array and Given® Recorder Battery Pack carefully. Do not expose them to shock,
vibration or direct sunlight, which may result in loss of information. Return all of the equipment to your
physician’s office as soon as possible.
11. The M2A™ Capsule is disposable and it will be excreted naturally in your bowel movement.
Patient Instructions
Jan 2001
Capsule Endoscopy Event Form
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ID no:
Event (eating, drinking and unusual sensations)
Ingestion
Excretion
Patient Instructions
Jan 2001

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