• Changing its installation layout,
• Moving the device,
• Operate changes in the supporting wall structure.
12.12 ELECTRICAL SAFETY
The operator must not inspect internal parts or disassemble any part of the device and of the workstation.
The unit must be installed solely in environments that meet safety standards and laws concerning premises used
for medical purposes.
The unit is not equipped with protective devices against penetration of liquids; therefore it is essential to ensure
that no water or other liquids can penetrate inside to prevent short circuits or corrosion.
Always disconnect the system from the power supply and the workstation before cleaning and disinfecting it.
Do not tread on the ETHERNET or on the CONTROL cable. Any damage to the conductors or connectors of these
cables can compromise the proper operation of the device, its communication circuits and the Workstation.
The installation of the equipment must be permanent (xed) in compliance with the IEC 60601-1 standard. It is
PROHIBITED to plug the device to the power supply.
Don’t connect the device to the mains before ensuring the correct power supply voltage, as indicated in the
identication plate. Incorrect voltage can cause irreversible damage to the electronic components of the medical
device.
The electrical system where the device is installed must be suitably earthed, in compliance with NEC and IEC
standards and with the laws in force in the country of installation.
For Italy: The electrical system where the device is installed must be made in a workmanlike manner and in
compliance with the IEC 64-8 standard with reference to premises used for medical purposes.
12.13 POSITIONING LASERS
X-MIND trium is a class 3R laser product. Avoid direct eye exposure to laser radiation. Viewing the laser
output with telescopic optical instruments (for example, telescopes and binoculars) may pose an eye
hazard and thus the user should not direct the beam into an area where such instruments are likely to be
used
Use of controls or adjustments or performance of procedures other than those specied herein may
result in hazardous radiation exposure
12.14 PATIENT DATA
Storage and Backups
The operator is responsible for the storage and backup of the data provided by the medical device. He should
store all the clinical les and the patient database in a safe location, such as a server, NAS or CD/DVD and not on
the Hard Disk of the medical workstation.
Patient database and clinical les must be backed up periodically. The manufacturer shall not be held liable for
damage due to data loss caused by failure to comply with these requirements and with the reference standards.
Data protection
The operator is responsible for the protection of the patient data and the compliance to with the local standards in
force. The operator must have appropriate security to prevent the patient data being accidentally or deliberately
compromised.
Security software like Firewall and Antivirus programs are necessary if the network environment of the workstation
is connected to the Internet or have a connection with external data (USB key or portable HDD).
The operator can contact Acteon Imaging
Customer Service for information about encryption and password protection in the Acteon Imaging software.,
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