Ideal Curves Ultimate Contour, Руководство пользователя

Страница: 6 / 24

6
is dry before using.
• Discontinue use if any portion of the system becomes broken, if cracks or deformations develop, or
discoloration occurs.
• This product contains no user serviceable parts beyond what is described in this manual.
• Failure of the Ultimate Contour to function as designed may result in an unintended increase in power
output.
• Power surges, or loss of power, may cause this device to momentarily lose power or to behave in an
unexpected manner. If this occurs or is observed, immediately halt handpiece emissions, then power
off and restart the device. Carefully observe device behavior when first resuming use. If any changes
are noted, discontinue use immediately.
• Use of the Ultimate Contour contrary to these instructions could constitute misuse or abuse of the
product.
•
• Patient Considerations:
• Patient should not eat any food at least 2 hours prior to treatment, and at least 1 hour after treatment.
• Patient must not consume any alcoholic beverages at least 48 hours prior and after treatment.
• Ultrasound should only be applied to the waist area. DO NOT apply ultrasound to any other part of the
body.
• Risk of neuromuscular stimulation may occur with Radio Frequency usage, particularly on dry skin
where an electric arc may occur.
• Reports of “fatty” or cloudy urine, and constipation, have been reported following application of the
ultrasound.
• Patient should not participate in a hot shower (warm is OK), hot bath, or sauna immediately after
treatment.
• Avoid use of water-based treatment gels as the water may react to the ultrasound energy.
• Avoid use on patients who are connected to an oxygen supply. DO NOT use in the presence of
flammable gases.
• All treatments performed with this system must be subjected to the same clinical assessment as with
traditional techniques. The patient risk and medical history must be considered and understood before
treatment. Caution must be exercised regarding general medical conditions not already mentioned
which might contraindicate a localized procedure. Medical clearance from the patient’s general
physician is advisable when doubt exists regarding the treatment.
2.3 Training
Use of this device is limited to a licensed and trained medical practitioner. Review with your governing
medical board and/or licensing agency regarding the licensing and training requirements for using this
device. Training for use of this device is available through Ideal Curves. When you purchased this product,
arrangement should have already been made for a qualified Ideal Curves staff member to come to your
office to conduct on-site training and to observe proper unpacking and setup of the system. If these
arrangements have not been made, please contact Ideal Curves to arrange this.
Additionally, instructional videos are available at our website: www.ultimate-contour.com.
2.4 Device Safety & Compliance
Carefully review and understand the Indications for Use in Section 2.1, and the Contra-Indications listed
in Section 2.2. This device has been designed and certified compliant to applicable national and interna-
tional safety standards for medical electrical devices of this type. These standards include IEC 60601-1,
IEC 60601-1-2, IEC 60601-1-6, EN60601-1, and CAN/CSA C22.2 No.60601-1. This product is also design and
constructed in compliance with U.S. FDA regulations regarding electronic products (21 CFR 1010), as well