Given Imaging Limited CAPDH-2 ユーザーズマニュアル
Indications for Use
3
Chapter 2
Indications, Contraindications, Warnings,
Cautions
Indications for Use
PillCam SB
The PillCam Capsule Endoscopy System with the PillCam SB capsule is intended for visualization of the
small bowel mucosa.
small bowel mucosa.
•
The PillCam Capsule Endoscopy System with the PillCam SB capsule may be used in the
visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and
lower endoscopy.
visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and
lower endoscopy.
•
The PillCam Capsule Endoscopy System with the PillCam SB capsule may be used in the
visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or
occult) not detected by upper and lower endoscopy.
visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or
occult) not detected by upper and lower endoscopy.
•
The PillCam Capsule Endoscopy System with the PillCam SB capsule may be used in the
visualization and monitoring of lesions that may be potential causes of iron deficiency anemia
(IDA) not detected by upper and lower endoscopy.
visualization and monitoring of lesions that may be potential causes of iron deficiency anemia
(IDA) not detected by upper and lower endoscopy.
The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of
containing blood or red areas.
containing blood or red areas.
The PillCam Capsule Endoscopy System with PillCam SB capsules may be used as a tool in the
detection of abnormalities of the small bowel and is intended for use in adults and children from two
years of age.
detection of abnormalities of the small bowel and is intended for use in adults and children from two
years of age.
PillCam ESO
The PillCam Capsule Endoscopy System with PillCam ESO capsules is intended for the visualization of
esophageal mucosa in adults and children from 18 years of age.
esophageal mucosa in adults and children from 18 years of age.
PillCam UGI
The PillCam UGI capsule endoscopy system is intended for visualization of the upper gastrointestinal
tract (esophagus, stomach, duodenum). It may be used for visualization of blood in the upper
gastrointestinal tract (esophagus, stomach, duodenum) in patients who are hemodynamically stable and
at least 18 years of age.
tract (esophagus, stomach, duodenum). It may be used for visualization of blood in the upper
gastrointestinal tract (esophagus, stomach, duodenum) in patients who are hemodynamically stable and
at least 18 years of age.