Given Imaging Limited CAPSH-3 Manual De Usuario
PillCam Capsule Endoscopy
10
Essential Performance
Essential Performance
PillCam Video Capsules
ON-Mode
Data transmitting to PillCam recorder is considered to be essential performance of the PillCam capsules.
The PillCam capsules shall transmit data continuously monitored by on-line image display as received by
PillCam recorder.
The PillCam capsules shall transmit data continuously monitored by on-line image display as received by
PillCam recorder.
OFF-Mode
No unintentional transmissions are allowed.
PillCam Recorder DR2 and PillCam Recorder DR3
Data receiving by PillCam recorder is considered to be essential performance of the PillCam recorder DR2
and PillCam recorder DR3.
and PillCam recorder DR3.
Accuracy of the Device—SB
The PillCam Capsule Endoscopy System with the PillCam SB 1 capsule was studied in a series of 20
subjects with hemoccult positive stool, iron-deficiency anemia, and/or subacute hematochezia or melena.
All patients had undergone unrevealing colonoscopy, gastroscopy, enteroscopy, and small bowel X-rays
prior to enrolling in the study. When compared to repeated push enteroscopy, the PillCam video capsule
was able to detect a pathological abnormality in 12 (60%) of the patients whereas enteroscopy detected
abnormalities in 7 (35%) of these patients. The 5 patients in whom lesions were found by the PillCam video
capsule but not enteroscopy all had abnormalities in the distal jejunum or ileum, outside the reach of most
standard enteroscopy examinations. The average length of insertion during enteroscopy was 2.3 meters.
Specific findings detected by the imaging system included arterio-venous malformations (AVMs), mucosal
erosions and ulcerations, and a submucosal tumor. In one case (5%), though the PillCam video capsule
detected a small bowel AVM that was found by enteroscopy, one out of the two reviewing physicians did
not detect the AVM when reviewing the RAPID video.
subjects with hemoccult positive stool, iron-deficiency anemia, and/or subacute hematochezia or melena.
All patients had undergone unrevealing colonoscopy, gastroscopy, enteroscopy, and small bowel X-rays
prior to enrolling in the study. When compared to repeated push enteroscopy, the PillCam video capsule
was able to detect a pathological abnormality in 12 (60%) of the patients whereas enteroscopy detected
abnormalities in 7 (35%) of these patients. The 5 patients in whom lesions were found by the PillCam video
capsule but not enteroscopy all had abnormalities in the distal jejunum or ileum, outside the reach of most
standard enteroscopy examinations. The average length of insertion during enteroscopy was 2.3 meters.
Specific findings detected by the imaging system included arterio-venous malformations (AVMs), mucosal
erosions and ulcerations, and a submucosal tumor. In one case (5%), though the PillCam video capsule
detected a small bowel AVM that was found by enteroscopy, one out of the two reviewing physicians did
not detect the AVM when reviewing the RAPID video.
Overall, the findings obtained from the PillCam Capsule Endoscopy System and standard enteroscopy
agreed in 14 cases (70%). The two methods revealed similar pathologies in 6 of these patients. Both exams
were normal in an additional 8 patients. [1]
agreed in 14 cases (70%). The two methods revealed similar pathologies in 6 of these patients. Both exams
were normal in an additional 8 patients. [1]
A total of 14 separate small bowel findings were eventually noted in 13 patients by either of the two
imaging modalities or by laparoscopic surgery. The PillCam Capsule Endoscopy System was able to
identify 12 of the 14 lesions (86%) while the enteroscopy detected 7 of the 14 lesions (50%). Both repeated
enteroscopies, small bowel X-rays and the PillCam video capsule, failed to detect an ulcerated Meckel’s
diverticulum found at surgery.
imaging modalities or by laparoscopic surgery. The PillCam Capsule Endoscopy System was able to
identify 12 of the 14 lesions (86%) while the enteroscopy detected 7 of the 14 lesions (50%). Both repeated
enteroscopies, small bowel X-rays and the PillCam video capsule, failed to detect an ulcerated Meckel’s
diverticulum found at surgery.
PillCam video capsule localization is based on off-line processing of the strength of the radio frequency
signals emitted from the PillCam video capsule as received by each of the eight sensors. The information
helps estimate the relative two-dimensional location of the PillCam video capsule with respect to the
umbilicus (e.g., abdominal quadrant).
signals emitted from the PillCam video capsule as received by each of the eight sensors. The information
helps estimate the relative two-dimensional location of the PillCam video capsule with respect to the
umbilicus (e.g., abdominal quadrant).