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EMC Declaration
1. Compliance Statement
This equipment complies with IEC 60601-1-2 EMC standards for medical devices.
This equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC
information provided in the user manual.
Do not use any wireless devices, including cellular phones, near the system. All wireless devices, whether they comply with
the EMC standard or not, may emit electromagnetic interferences and cause the system to malfunction when they are used
nearby.
This equipment should not be used adjacent to or stacked with other equipment; if adjacent or stacked use is necessary,
the equipment should be tested and verified in order to ensure normal operations in the configuration in which it will be
used.
Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to
operate the equipment.
All interconnect cables to peripheral devices must be shielded and properly grounded, except when technologically
prohibited. Use of cables not properly shielded and grounded may result in the equipment causing radio frequency
interference.
Port
No.
1
*Note: I/O = Signal Input or Output Port (Not Involved in Process Control)
The use of cables or accessories other than those specified may result in increased emissions or decreased immunity.
Should any interference (EMC) be detected with other equipment, please position other equipment away from this one.
When using this system on a patient with an implantable pacemaker or an implantable cardioverter defibrillator, the
patient must be informed that continuous X-ray exposure in pulse form may cause the pacemaker or cardioverter
defibrillator to malfunction.
When using this system, ensure that X-rays are not exposed directly onto the patient's implantable pacemaker or
implantable cardioverter defibrillator, and that the exposure time is kept as short as possible.
This equipment may be interfered with by other equipment, even if that other equipment complies with CISPR EMISSION
requirements.
EMC Cable List
Cable
Name
Type*
Max. > 3 m
Signal
Tether cable
I/O
7.0
51
Cable
Comments
Shielded
Shielded
None
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