Ulthera DeepSEE DS 4 - 4.5, Instructions For Use Manual

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Ulthera, Inc.
Floors should be wood, concrete or ceramic tile. If floors are covered with
synthetic material, the relative humidity should be at least 30% to avoid
excessive static electricity.
Warning: The Ulthera System should not be situated adjacent to, or
stacked with, other electronic equipment. If the system must be installed
in close proximity to other equipment, both the Ulthera System and the
nearby equipment should be observed to verify normal operation in that
configuration.
Caution: EMI (Electro-Magnetic Interference) from other electronic
systems may cause degradation of the ultrasound image. Ulthera has
been designed to meet the standards of IEC60601-1-2 for
electromagnetic compatibility; however some computer equipment
unintentionally emits strong interfering RF signals. Portable RF
communication devices may also affect Ulthera. If image quality is
degraded by EMI, the system may need to be relocated or
reconfigured.
Warning: Use of accessories other than those specified, may result in
increased emissions, or decreased immunity of this system.
4.5.1. Guidance and Manufacturer’s Declaration – Electromagnetic
Emissions
The Ulthera system is intended for use in the electromagnetic environment
specified below. The user should assure that it is used in such an environment.
Table 4.5 Electromagnetic Emissions
EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT - GUIDANCE
RF emissions
(CISPR 11)
Group 1
The Ulthera system uses RF energy only for its
internal function. Therefore, its RF emissions are
v ery low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions
(CISPR 11)
Class A
Ulthera is suitable for use in all establishments
other than domestic and those directly
connected to the public low v oltage power
supply network that supplies buildings used for
domestic purposes.
Harmonic
emissions (IEC
61000-3-2)
Class A
Voltage
fluctuations/flicker
(IEC 61000-3-3)
Complies