KaVo ORTHOPANTOMOGRAPH OP 3D, Руководство пользователя

Страница: 9 / 109

2 Introduction
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.
• Always use new disposable covers on patient positioning accessories and decontaminate the
patient contacting parts according to guidance in chapter Cleaning and decontamination on page
70 to prevent cross contamination.
• If patient positioning accessories show any signs of deterioration, replace them before use.
• Clean the patient positioning accessories before their first use.
• Avoid taking X-ray images of pregnant women.
• 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.
• Follow the ALARA (As Low As Reasonably Achievable) principle and always seek to reduce the
radiation dose.
• Use the pediatric programs always when taking X-ray images of pediatric patients and where
feasible, adjust the radiation field size.
• Where it is likely that evaluation of soft tissues will be required as part of the patient’s radiological
assessment, the imaging should be done using conventional medical CT or MR, rather than 3D
imaging using Cone Beam technology.
• The device must not be used for screening examinations.
• Always ensure the patient positioning before taking X-ray images to diminish the need for retakes.
• Always ask the patient to remain still for the duration of the exposure 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.
• Always ensure that you can see and hear the patient during the imaging process, while also
maintaining visibility to the GUI.
• 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.
• Close the patient positioning mirror before taking images.
• Switch the device off after use.
• Report any incident, related to use of this device, having a serious effect on the health of a patient,
user or other person to the manufacturer and to the local competent authority.
ORTHOPANTOMOGRAPH
™
OP 3D 9