5
joints, mesh, clips, orthopedic hardware).
• DO NOT
use if patients are taking medications such as anti-aggregation medications (NSAIDS), Isotreti-
noin (Roaccutane), or rosuvastatin (Crestor).
• DO NOT
use the device at all on, near, or around implanted electrical medical devices (examples: pace-
makers, insulin pumps).
• DO NOT
use treatment gels, oils or solutions that have alcohol or a highly flammable substance as the
base carrier. Ignition may occur. Avoid letting these materials pool or collect in depressions or body
cavities, such as the navel. If alcohol is used for cleaning purposes, allow thorough drying before device
use.
• WARNING:
Device contains high-voltage components. Changes or modifications to the equipment
not expressly approved by Ideal Curves or described in this manual could void the user’s authority to
operate the equipment. Unauthorized alterations may result in electric shock or damage to patient
tissues.
• WARNING:
To avoid the risk of electric shock, this equipment must only be connected to a wall outlet
or surge protector with a third ground pin socket. Failure of the equipment may resulted in an unin-
tended increase in output power.
• WARNING:
Use of the Ultimate Contour adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, the Ultimate Contour
and the other equipment should be observed to verify that they are operating normally.
• WARNING:
Use of accessories and cables other than those specified for the Ultimate Contour or
provided by Ideal Curves could result in increased electromagnetic emissions or decreased electromag-
netic immunity of the Ultimate Contour and result in improper operation.
• WARNING:
Portable RF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Ultimate
Contour, including cables specified by Ideal Curves. Otherwise, degradation of the performance of this
equipment could result.
• CAUTION:
Use of ultrasound on body parts other than the waist, or on tissue that has a low adipose or
fatty content may result in rapid heating, tissue damage, and/or the formation of fistulas.
• CAUTION:
DO NOT store liquids on the unit.
• CAUTION:
Use of controls or adjustments or performance of procedures other than those specified
herein may result in hazardous exposure to radio frequency or ultrasound energy.
• CAUTION:
Always stop the treatment before removing the handpiece from contacting the patient.
Removing the handpiece while the energy is emitting may result in electric shock or damage to the
tissue.
• CAUTION:
Federal law restricts this device to sale by or on the order of a physician.
• Device is only to be used in a professional medical office environment, where environmental controls
are in place. Specifically, the device should not be used in a dry or arid environment where the relative
humidity in the room is < 35%. See Section 9.1.
• When using the ultrasound handpiece, gas bubbles may form at the surface of the handpiece. Ensure
that treatment oils are used that are suitable for ultrasound use to maintain contact between the
handpiece and the skin (see page 9).
• Locate the device on a table, counter, or cart when in use. DO NOT place the device on the floor when
using.
• Ensure all other radio frequency emitting devices (example: cell phones, computers and wireless
computer devices, routers, wireless phones) or devices that may generate a strong electromagnetic
field (example: MRI, electrosurge) are kept more than 3 meters (10 feet) away from this device, the
treatment table, the operator, or the patient.
• Avoid use of the device if liquids are spilled on the unit. Wipe up spills immediately and ensure the unit
Summary of Contents for Ultimate Contour
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