Given Imaging Limited CAPDH-2 Manual De Usuario
Indications, Contraindications, Warnings, Cautions
Warnings
7
•
Instruct the patient to wear the PillCam recorder throughout the procedure for as long as the
PillCam recorder LED continues to blink at the ingested capsule's blinking rate.
PillCam recorder LED continues to blink at the ingested capsule's blinking rate.
•
Review the time bar of the RAPID video to determine if video gaps exist, which may result in the
need to repeat the capsule endoscopy procedure. This is important if the procedure results in a
normal or negative capsule endoscopy examination.
need to repeat the capsule endoscopy procedure. This is important if the procedure results in a
normal or negative capsule endoscopy examination.
•
Occasionally, some images may be lost (less than 3% for COLON 2 and UGI procedures and less
than 1% for SB procedures) which results in video gaps (shown as a gray section on the time bar
display of the RAPID video) due to radio interference (e.g., from amateur radio transmitters, RFID
(radio-frequency identification) systems, MRI). This may result in the need to repeat the capsule
endoscopy procedure. In such a case, advise the patient to stay within the premises of the clinic for
the duration of the second capsule endoscopy procedure to prevent this problem from recurring.
than 1% for SB procedures) which results in video gaps (shown as a gray section on the time bar
display of the RAPID video) due to radio interference (e.g., from amateur radio transmitters, RFID
(radio-frequency identification) systems, MRI). This may result in the need to repeat the capsule
endoscopy procedure. In such a case, advise the patient to stay within the premises of the clinic for
the duration of the second capsule endoscopy procedure to prevent this problem from recurring.
Electromagnetic Compatibility Related:
•
After ingesting the PillCam video capsule and until it is excreted, the patient should not be near any
source of powerful electromagnetic fields such as one created near an MRI device.
source of powerful electromagnetic fields such as one created near an MRI device.
•
Keep the magnet of the PillCam video capsule’s packaging away from implants such as
pacemakers, defibrillators, nerve stimulators, and other devices that could be affected by proximity
to a DC magnetic field.
pacemakers, defibrillators, nerve stimulators, and other devices that could be affected by proximity
to a DC magnetic field.
•
PillCam Capsule Endoscopy System and its components need special precautions regarding
Electromagnetic Compatibility (EMC) to avoid loss of image transfer resulting in video gaps.
PillCam Capsule Endoscopy System needs to be installed and put into service according to the
Electromagnetic Compatibility (EMC) information provided in the accompanying documents.
Electromagnetic Compatibility (EMC) to avoid loss of image transfer resulting in video gaps.
PillCam Capsule Endoscopy System needs to be installed and put into service according to the
Electromagnetic Compatibility (EMC) information provided in the accompanying documents.
•
The use of the accessory with PillCam capsule other than those specified may result in increased
emissions or decreased immunity of the PillCam capsule.
emissions or decreased immunity of the PillCam capsule.
Recorder Related:
•
A PillCam video capsule should be ingested only in the presence of authorized medical personnel.
The patient should be instructed not to let relatives, neighbors or acquaintances use any PillCam
video capsule without medical attention.
The patient should be instructed not to let relatives, neighbors or acquaintances use any PillCam
video capsule without medical attention.
•
If excretion of the PillCam video capsule from the patient has not been positively verified, and the
patient develops unexplained post-procedure abdominal pain, vomiting, or other symptoms of
obstruction, he/she should contact the physician for evaluation and possible abdominal X-ray
examination.
patient develops unexplained post-procedure abdominal pain, vomiting, or other symptoms of
obstruction, he/she should contact the physician for evaluation and possible abdominal X-ray
examination.
•
Never connect the PillCam recorder to the sensor array while the PillCam recorder is in its cradle.
•
The PillCam video capsule and PillCam recorder should not be used adjacent to or stacked with
other equipment and that if adjacent or stacked use is necessary, the equipment or system should be
observed to verify normal operation in the configuration in which it will be used.
other equipment and that if adjacent or stacked use is necessary, the equipment or system should be
observed to verify normal operation in the configuration in which it will be used.
•
Portable and mobile RF communications equipment can affect the PillCam video capsule and the
PillCam recorder.
PillCam recorder.
•
The PillCam video capsule may be interfered with by other equipment, even if that other
equipment complies with CISPR emission requirements.
equipment complies with CISPR emission requirements.
•
The Lithium-Ion battery pack in the PillCam recorder DR3 incorporates built-in safety devices.
•
Do not use the PillCam recorder in a location where static electricity (greater than the
manufacturer’s guarantee) may be present. Otherwise, the safety devices can be damaged, possibly
leading to acid leakage, overheating, smoke emission, bursting and/or ignition.
manufacturer’s guarantee) may be present. Otherwise, the safety devices can be damaged, possibly
leading to acid leakage, overheating, smoke emission, bursting and/or ignition.