Hologic R2 DM, User Manual

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1.3. Warnings and Cautions
Cautions: System Operation
•
Operators should review this user manual and receive training before using the
system.
•
To ensure optimal system performance, perform the system verification tests and
scanner maintenance procedures as instructed in this user manual.
•
To ensure proper system operation, use only separator sheets and barcodes
provided by Hologic.
•
To properly identify patients in the archive system, be sure to enter the patient
information and the barcode from the separator sheet into the patient
identification system correctly.
•
For sites with multiple processing systems: When entering data into the R2 Patient
ID web page, check the name of the processing unit on the web page to ensure that
you are entering the patient information into the processing unit that you will use
to scan the case.
•
For the display images to correspond correctly to the film position at the display
unit, be sure to orient and order the films correctly when scanning, as described in
this user manual.
•
Ensure that the case retrieved from the archive to be used for comparison is from
the same patient as the current case under review. It is recommended that you use
the patient flash for this confirmation.
•
Use only standard mammographic film: 18 × 24 cm or 24 × 30 cm.
•
Do not attempt to scan films that have labels or tape with edges within 1 mm of
the edge of the film, or labels that are not pressed flat, or have curled corners, as
they may jam.
•
Do not attempt to scan bent, damaged, or curled films, as they may jam. Be sure
to remove paper clips or other foreign materials from the films.
•
Always shut down the system according to the procedures provided in this user
manual. Failure to shut the system down properly can cause loss of data or damage
to the computer operating system.
•
This equipment has been tested and found to comply with the limits for a Class A
digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to
provide reasonable protection against harmful interference when the equipment is
operated in a commercial environment. This equipment generates, uses, and can
radiate radio frequency energy and, if not installed and used in accordance with
the instruction manual, may cause harmful interference to radio communications.
Operation of this equipment in a residential area is likely to cause harmful
interference, in which case the user will be required to correct the interference at
her or his own expense.
Note: The device design and mode of operation are consistent with current standard
mammography clinical practices, as governed by the requirements of the Mammography
Quality Standards Act (MQSA) of 1992. Users are cautioned to comply with the MQSA or
the appropriate national standards, when implementing R2 systems in clinical protocols.
R2 DM User Manual – PN MAN-01044 Rev 001 5