Given Imaging Limited CAPDH-2 Manuale Utente
PillCam Capsule Endoscopy
214
Essential Performance
Capsule Labeling
Each box has a label at the bottom as shown below. Each capsule is marked with the expiration date, lot
number, and a unique capsule ID code.
Essential Performance
PillCam 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.
Warnings
•
PillCam Capsule Endoscopy System and its components need special precautions regarding EMC and
need to be installed and put into service according to the EMC information provided in the
accompanying documents.
need to be installed and put into service according to the EMC information provided in the
accompanying documents.
•
Portable and mobile RF communications equipment can affect the PillCam video capsule and the
PillCam recorder.
PillCam recorder.
•
PillCam video capsules 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.
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.
Lot Number
Expiration
Date
Date
Capsule ID
Code
Code