EN 50419 symbol
Indications for Use
Virtua Series devices are intended for digital medical image communication, processing, and
storage. Functions include transfer, “viewing client on CD/DVD” provision, storage, archive,
recording, and labeling of CD/DVD media. When configured, the ability to re-direct all or part
of a radiographic study to Codonics Horizon Series Medical Hardcopy Dry Imagers (Pre-
market notification K021054) or other approved 892.2040 medical hardcopy imager/printer is
provided. Typical users of this system are trained professionals, including but not limited to
physicians, nurses, and technicians.
Additional Warnings
WARNING
The shipping cartons are heavy. To avoid injury, use two people to unpack and
position the components.
WARNING
When removing the Controller or Recorder, hold under the front and rear of the
device. Do not lift device by the foam packaging.
WARNING
Before placing the Recorder on top of the Controller, make sure your fingers are
not under the Recorder to avoid pinching them.
WARNING
The power cord plug is the main disconnect for the device. The power outlet
should be near the device and be easily accessible.
WARNING
Remove the power cord plug from the power outlet to disconnect overall power to
the device.
WARNING
Grounding reliability can be achieved only when the equipment is connected to an
equivalent receptacle marked “Hospital Only” (that is, “Hospital Grade”).
WARNING
To avoid risk of electrical shock, this equipment must only be connected to a
supply main with protective earth.
WARNING
Before powering on the unit, make sure that the Recorder’s pick arm is not
holding a disc. If it is, remove the disc.
WARNING
Do not touch the copper area of the cartridge print head.
WARNING
The SmartDrive must be inserted for the device to operate. If the SmartDrive is
not inserted, the device can boot up but will not be able to process jobs.
WARNING
If the SmartDrive is removed improperly while a study is being processed, file
corruption could occur.
WARNING
Discs that
fail to record properly are either labeled with the word “Reject” or not
labeled at all. These discs should be destroyed to protect the confidentiality of patient data.
WARNING
Deleting a job that is in-progress can result in a disc that is either labeled with the
word “Reject” or not labeled at all. These discs should be destroyed to protect the
confidentiality of patient data.