2 Introduction
• All electronic circuits and electronic boards
• Plastic parts
2.8 Warnings and requirements
2.8.1 Warnings and precautions for use
• Before using the device for the first time, familiarize yourself with this manual to
ensure the safe use of the device.
• Before using the device for the first time, ensure that it has been set up according to
your requirements.
• This device complies with the EMC (Electromagnetic Compatibility) according to IEC
60601-1-2. Radio transmitting equipment, cellular phones etc. shall not be used in
proximity of the device as they could influence the performance of the device.
• Do not move the upper shelf of the device by hand as it may hit a wall or cause the
device to go to an error state.
• If the patient is using a pacemaker, consult the manufacturer of the pacemaker before
taking an X-ray image to confirm that the device will not interfere with the operation
of the pacemaker.
• Always ensure the patient positioning before taking X-ray images to diminish the need
for retakes.
• When taking an X-ray image, protect yourself from radiation or stand at least 3
meters (9.8 ft) away from the device.
• When taking an X-ray image of a patient who is feeling insecure or has exceptional
anatomy (typically very tall or large patient) use the Test-mode first to demonstrate
the device movements and to make sure that the rotating device doesn't collide with
the patient during the imaging process.
• Avoid taking X-ray images of pregnant women.
• Always ensure that you can see and hear the patient during the imaging process,
while also maintaining visibility to the GUI.
• Always place new disposable covers on patient positioning parts and decontaminate
the patient contacting parts according to guidance in chapter
Cleaning and
decontamination
.
• Close the patient positioning mirror before taking images.
• Switch the device off after use.
• The device must not be used for screening examinations.
2.8.2 Warnings and precautions for installation
• Only authorized service technicians are allowed to perform the device installation or
service.
• The column telescope assembly is not a serviceable part and it should not be opened
or altered in any circumstances.
• Always ensure that the device is isolated from mains during any installation or service
procedures to avoid a risk of electric shock. Live parts are marked with high voltage
symbols.
• Familiarize yourself with this manual before device installation and follow the
installation instructions to ensure the safe use of the device.
ORTHOPANTOMOGRAPH
™
OP 3D
9
