Given Imaging Limited SMARTPILL 用户手册
Appendix: Electrical Safety
The receiver’s battery life.
1 bar = 1 day of battery life.
3 bars = 3+ days.
3 bars = 3+ days.
Risks and Safety
Warning
This device does not differentiate between slow motility and functional outlet obstruction.
Non-Passage
Risks associated with capsule ingestion and transit are minimal. The primary hazard is
Risks associated with capsule ingestion and transit are minimal. The primary hazard is
capsule retention. Retention incidence, as determined by a review of published studies
of capsule endoscopy in adults, is estimated as 0.75% in patients without known
stenosis and 21% in patients with known stenosis. Stenosis and strictures can be
stenosis and 21% in patients with known stenosis. Stenosis and strictures can be
complications in inflammatory bowel disease.
If you suspect a delay in passage and the Capsule is located in the stomach, a pro-
If you suspect a delay in passage and the Capsule is located in the stomach, a pro-
motility drug could be administered to assist in emptying the capsule from the
stomach. Alternatively, endoscopy could be performed in order to retrieve the capsule.
stomach. Alternatively, endoscopy could be performed in order to retrieve the capsule.
If located in the colon, laxative therapy could be administered to facilitate capsule
movement, or a colonoscopy could be performed in order to retrieve the capsule.
Adverse events reported in clinical studies involving the SmartPill are listed below.
Adverse events reported in clinical studies involving the SmartPill are listed below.
Reported Adverse Events in Clinical Study Subjects (n=484)
Number of Events Reported
59
Number not related to the device
33
Number probably not related to the
device
17
Number possibly related to the device
5
Number definitely related to the device
4
Reported Adverse Events in Clinical Practice
In clinical practice since 2007, the company identified 25 events whose circumstances
suggested a potentially reportable event to regulatory authorities. After investigation
suggested a potentially reportable event to regulatory authorities. After investigation
and follow up, seven of these events were deemed reportable including three instances
of esophageal retention, one gastric retention and three small bowel retentions.
Surgery was required for resolution in one instance of capsule small bowel retention
that led to identification of a stricture. A bowel prep resolved the second instance of
that led to identification of a stricture. A bowel prep resolved the second instance of
small bowel retention, and the third resolved with fluids and bed rest. Capsule
retention in the stomach was resolved endoscopically. Two of the retentions in the
esophagus were resolved endoscopically and in the third instance the patient vomited
and then performed a self-applied Heimlick maneuver to expel the capsule. There
and then performed a self-applied Heimlick maneuver to expel the capsule. There