Preparation For Use; Directions For Use - CapsoVision CapsoCam Plus Handbuch

Bowel Preparation
Patient should follow physician' s instructions for bowel
preparation.

Preparation for Use

• Inspect the foil seal. Do not use if any breakage in the foil
seal or in the foil itself is observed.
• Prepare a glass or bottle of water. The recommended
amount of water is 0.5 liter (~16 fluid ounces).

Directions for Use

1. Open the capsule package by peeling back the foil cover.
2. Using gloves, remove the plastic lid covering the capsule.
3. Grasp the capsule carefully and then pull it out and away
from the package. Take care not to drop the capsule
on the floor. Dropping the capsule may damage it, which
could result in an incomplete examination.
4. Within approximately ten seconds of being removed from
the magnet, the capsule LEDs will light up in a consistent
rhythm of approximately 5 flashes per second, indicating
that the capsule is activated. Because CapsoCam Plus uses
auto-illumination to optimize lighting conditions for in vivo
images, it is possible that not all capsule LEDs will appear
illuminated. If unsure that the capsule is flashing,
enclose the capsule in your hand to provide a dark
environment to confirm that the LEDs are illuminated.
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Document Number: IFU-2320 Rev: H Revision Date: 8/28/2019
Once you have confirmed that the capsule is flashing, the
capsule is ready to be swallowed.
If the capsule has not begun flashing within 20 seconds
after being removed from the package, place the battery-
end of the capsule against the magnet in the package and
repeat step 4 again. If the capsule still fails to begin
flashing, the capsule is malfunctioning and should be
replaced.
5. The capsule must be swallowed within 10 minutes of being
removed from the package. The capsule should be placed
inside the patient' s mouth and swallowed with the entire
glass of water. Patients should avoid biting the capsule. If
the patient is unable to swallow the capsule within 10
minutes, return the capsule to the package with the
battery-end of the capsule touching the magnet inside the
package, which returns the capsule to the "OFF" state.
6. The patient may engage in normal daily activities while the
capsule moves within the digestive tract. The patient should
consult the physician if he or she has questions about
engaging in a particular activity.
7. Notify the patient that the capsule is typically excreted
between 3 and 30 hours after being swallowed. Patient
must retrieve the capsule by following the Capsule Retrieval
Kit Instructions for Use.