Warnings And Precautions For Installation; Connection Requirements - KaVo ORTHOPANTOMOGRAPH OP 3D User And Installation Manual

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.
• Always use new disposable covers on patient positioning parts and decontaminate
the patient contacting parts according to guidance in chapter
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.
• Familiarize yourself with this manual before device installation and follow the
installation instructions to ensure the safe use of the device.
• 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 power during any installation or
service procedures to avoid a risk of electric shock. Live parts are marked with high
voltage symbols.
• To avoid the risk of electric shock, the device must only be connected to a mains
power outlet with protective earth.
• The device shall not be connected to an extension cord.
• Ensure the proper tightness and attachment of all of the screws and bolts when
installing the device.
• All device covers must be properly installed before handing the device to the user.
• Ensure the electrical safety of the device by inspecting the proper grounding of user
touchable metallic parts before handing the device to the user.

2.8.3 Connection requirements

NOTICE! Always follow local and national requirements regarding the connection
of medical systems.
• The workstation and any other external device(s) connected to the device must meet
the IEC 60950 standard (minimum requirements). Devices that do not meet the IEC
60950 standard must not be connected to the device as they may pose a threat to
operational safety. After installation, ensure that the IEC 60601-1 leakage current
levels are not exceeded.
• The workstation and any other external devices must be connected in accordance with
IEC 60601-1.
• Electronic equipment (workstation, network connecting devices etc.) that does not
fulfill medical safety standards (IEC 60601-1) must be located outside of the patient
environment, at least 1.5m from the device.
• The X-ray device must be connected to a dedicated mains power outlet with
protective earth. The workstation and any other external devices must NOT be
connected to the same outlet as the X-ray device.
ORTHOPANTOMOGRAPH
Reviewed Suuronen Esa 2019-09-19 12:21
Approved Lassinen Juuso 2019-10-02 14:37
on page 66 to prevent cross contamination.
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OP 3D
2 Introduction
Cleaning and
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