Given Imaging GIVENIMAGING User Manual Revisions

Given Imaging Limited Revisions

User Manual Revisions

March 29, 2001
Joe Dichoso
Office of Engineering and Technology Laboratory
Federal Communications Commission
7435 Oakland Mills Rd
Columbia MD 21046-1609
Re: Given Imaging
Application EA99991
Corres. Ref. # 18593
Dear Mr. Dichoso:
Following are revisions to the User’s Manual submitted as an exhibit to
the above-referenced application. These revisions are provided in response to the
correspondence reference number above.
The changes deal with the instruction to the physician regarding the brief
period of time between when the physician takes the M2A Capsule out of its
packaging and the Capsule being ingested by the patient. These changes reflect
our conversation on this subject in response to the correspondence referred to
above, 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 be
implemented 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 or
further requests for information or revisions. Thank you.
Sincerely
Ronnie London
Counsel for Given Imaging
Attachments
Overview
Given Imaging Ltd. 4
The M2A™ Capsule starts immediately after its removal
from the proximity of the magnet in the blister and the
consequent closing of the magnetic switch in the capsule.
After a brief (less than one minute) test by the physician to
verify that the capsule is active, the capsule is ingested by the
patient.
In order to minimize the potential for radiofrequency
interference from the device after removing it from the
blister package and until it is ingested by the patient, the
M2A™ 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 2
images per second. For each image, an illuminating light
flash of 100ms is applied with the illuminating LEDs. When
the battery power is depleted, the transmitter disables the
imager and switches the M2A™ Capsule off.
For specification and technical parameters of the M2A™
Capsule, refer to System Specifications on page 15. For
Indications and Contraindications, refer to Indications and
Contraindications on page 9.
Capsule Endoscopy
Given Imaging Ltd. 85
The Data Recorder LED starts blinking green.
5. Instruct the patient to take the M2A™ Capsule out of its
holder.
6. Ask the patient to put the M2A™ Capsule in his/her
mouth, and to hold it under the tongue WITHOUT
INGESTING.
7. If after a short adjustment period, with the M2A™
Capsule in the patient’s mouth, the green light keeps on
blinking, ask the patient to ingest the capsule with a sip
of water.
Note:
The time elapsed between capsule activation and
ingestion should usually not exceed 1 minutes.In
order to minimize the potential for
radiofrequency interference from
the device after removing it from
the blister package and until it is
ingested by the patient, the M2A™
capsule should be tested as quickly
as possible. After verification
that the M2A™ capsule is
operational – it should be
immediately ingested by the
patient.
8. In the Event Form, write down the ingestion time of the
M2A™ Capsule.

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