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 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 Make sure that the voltage supply selection switches are set to the appropriate voltage for the
applicable country.
WARNING To avoid damaging the Display screen, keep the protective cover in place until assembly is complete.
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. A message at the Display will prompt you to insert the
SmartDrive.
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 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.
WARNING Virtua log files might contain patient information. Use caution when distributing log files.
WARNING Always power off the device and disconnect the device’s power cords before cleaning. Resume
operation only after the surfaces are completely dry.
WARNING Run the Robotic Arm Calibration utility only when requested by Codonics Technical Support
personnel.
WARNING Initiate a remote access connection to Codonics only when requested by Codonics Technical Support
personnel.
WARNING System logs do not have the same user interface appearance and behavior as other screens. These
logs should not be accessed unless requested by Codonics Technical Support personnel.
WARNING Virtua log files might contain patient information. Use caution when distributing log files.
WARNING This device contains lead. Disposal of lead may be regulated due to environmental considerations.
For disposal or recycling information, please contact your local authorities or the Electronics Industry Alliance ().
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