KaVo ORTHOPANTOMOGRAPH OP 3D, Руководство пользователя и инструкция по установке

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2 Introduction
• 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.
• Additional multiple socket-outlets or extension cords shall not be connected to the
system.
• The device must be connected to a private, firewall protected LAN network.
• Connecting the device to an IT-network that includes other equipment or changing the
IT-network can cause unidentified risks to patients or operators. It is the responsibility
of the organization controlling the IT-network to identify, analyze, evaluate and
control these possible risks.
2.8.4 Device modifications
CAUTION! The device does not contain user serviceable parts. Only authorized
service technicians are allowed to service, install and replace parts of the device.
CAUTION! Only approved spareparts supplied by the manufacturer are allowed
to be used in device service.
• Never make unauthorized changes or modifications to the device or any of its parts.
• Never remove or remanufacture any part of the tubehead assembly or beam limiting
device.
• Never adjust any part of the beam limiting device unless under the direction of the
manufacturer.
• All required information on the device service and part replacement is found in the
Service Manual, which is available for authorized service technicians.
10 ORTHOPANTOMOGRAPH ™ OP 3D