Page 32 Ulthera, Inc
5. Setting Up for First-Time Use
5.1. Unpacking
The control unit and handpiece are shipped together in one container.
Transducers are packaged and shipped separately from the control unit and
handpiece, in ready-to-use, non-sterile pouches.
5.2. Physical Env ironment
5.2.1. System Base
The System may be placed on a cart or counter with the depth to
accommodate the control unit, handpiece and power cord provided. A
cart is recommended to offer maximum mobility for the user when treating
the patient and provide a more secure housing for the handpiece. System
weight and dimensions are listed in the Technical Information Manual –
Ulthera System Specifications.
Space should be provided around the back, sides, bottom and top of the
System for cooling. In continuous use for extended periods of time, it is
normal for the System to be warm.
5.2.2. Electromagnetic Environment (see the detailed EMC Guidance in
Section 3 of the Technical I nformation Manual)
The System is not likely to cause interference in nearby electronic equipment;
however, other electronic equipment should not be stacked or placed
immediately adjacent to the System.
Flooring should be wood, concrete or ceramic tile. If covered with synthetic
material, the relative humidity should be at least 30%.
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. The
Ulthera System 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 the Ulthera System. If image
quality is degraded by EMI, the system may need to be relocated or
reconfigured.
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