Document #82070-646, Revision C
CONFIDENTIAL
©2010 VTS Medical Systems, LLC
Page 38 of 40
XI. System Compliance Statements
When using USB devices do not touch the USB ports. Contacting the ports may create electrostatic
discharge (ESD) which may cause the system to freeze and prevent the USB peripherals from functioning
properly. Before restarting the computer, attempt to restore functionality by unplugging the USB device
and re-plugging it back into the port. Wait approximately 10 seconds to determine if functionality has been
restored. If not, restart the computer.
Precautions
This equipment/system is intended for use by healthcare professionals only. This
equipment/system may cause radio interference or may disrupt the operation of nearby
equipment. It may be necessary to take mitigation measures, such as reorienting or relocating the
equipment or shielding the location.
The system must be installed per the requirements of this manual. Failure to properly install the
system may result in degraded performance or loss of functionality.
Mobile and portable RF communications equipment may affect the system.
If the system is installed near or on other electronic devices, please observe to verify normal
operation. Other devices may emit harmful radiation or interference that could affect system
performance.
Use of accessories and cables other than those provided with the system could result in
increased emissions or decreased immunity of the equipment and may cause the system to be
non-compliant with the requirements of IEC 60601-1-2:2004.
IEC 60601-1-2:2004 Table 201 Requirements
The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the equipment
should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions CISPR 11
Group 1
The equipment uses RF energy only for its internal function. Therefore, its RF
emissions are very low and are not likely to cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11
Class A
The equipment is suitable for use in all establishments other than domestic, and may
be used in domestic establishments and those directly connected to the public low-
voltage power supply network that supplies buildings used for domestic purposes,
provided the following warning is heeded: Warning: This equipment/system is intended
for use by healthcare professionals only. This equipment/ system may cause radio
interference or may disrupt the operation of nearby equipment. It may be necessary to
take mitigation measures, such as re-orienting or relocating the equipment or shielding
the location.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Class A
IEC 60601-1-2:2004 Table 202 Requirements
The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the Equipment
should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment – guidance
Electrostatic discharge
(ESD) IEC 61000-4-2
±6 kV contact ±8 kV air
±6 kV contact ±8 kV air
with documented
necessary
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30 %.
