2 Introduction
2.8.2
Connection requirements
NOTICE!
Always follow local and national requirements regarding the connection of medical
systems.
NOTICE!
The workstation firewall or antivirus software may cause unexpected issues to IP traffic
and system performance.
• A network connection between the device and the acquisition workstation is required for the device
to be used. If the network is interrupted during the imaging process, the image data is saved to the
device memory and is transferred to the acquisition workstation automatically after the connection
is re-established.
• The device must be connected to a private, firewall protected local area network to ensure proper
data security. All connections from outside of the local area network to the device must be blocked.
Connections between the device and the workstation in the local area network must be allowed.
• Connecting the device to an IT-network that includes other equipment or changing the IT-network
can cause unidentified safety or security 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.
• Network elements used in the IT-network must not use their default passwords.
• The workstation and any other external device(s) connected to the device must meet the
IEC 60950
(62368-1)
standard (minimum requirements). Devices that do not meet these requirements must
not be connected to the device as they may pose a threat to the operational safety.
• Electronic equipment (workstation, network connecting devices etc.) that
do not
fulfill medical
safety standard
IEC 60601-1
must be located outside of the patient environment, at least 1.5 m
from the device.
• The workstation and any other external devices must be connected to the device in accordance
with IEC 60601-1.
• The workstation connected to the device must use an antivirus software and have individual
password protected user accounts to prevent unauthorized access to patient data.
• The 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
device.
• Additional multiple socket-outlets or extension cords shall not be connected to the system.
2.8.3
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 spare parts 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 devices.
• Never adjust any part of the beam limiting devices 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
