Ideal Curves 005-00036 Скачать руководство пользователя страница 6

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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 

Содержание 005-00036

Страница 1: ......

Страница 2: ...up 9 4 3 Registration 9 4 4 Handpiece Attachment 9 5 DEVICE OPERATION 10 5 1 Patient Preparation 10 5 2 Screens and Settings 10 5 3 Radio Frequency Treatment 13 5 4 Ultrasound Treatment 14 5 5 Concluding the Treatment 14 6 CLEANING AND MAINTENANCE 15 6 1 Handpiece Cleaning and Inspection 15 6 2 Unit Cleaning 15 6 3 Fuse Replacement 16 7 LIMITED WARRANTY 16 7 1 Limited Warranty Statement 16 7 2 Ser...

Страница 3: ...ly Failure to read these instructions may result in damage to the device or risk of injury to you or to the patient It is advisable to keep this document with the device and refer to it often when questions arise regarding its use and care If at any point you have any questions about the use or application of the Ultimate Contour feel free to contact a customer service representative at 1 888 861 ...

Страница 4: ...ns with a Body Mass Index BMI under 25 DO NOT use radio therapy on or near the face or neck DO NOT use on pregnant or nursing women on those who have given birth in the last 12 months or on those planning to become pregnant DO NOT use near plastic or metal parts within the body example implants stents ports Do not allow the transducers to contact hard surfaces when activated DO NOT use on patients...

Страница 5: ...als 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 damag...

Страница 6: ...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...

Страница 7: ...he waist circumference of patients using the ultrasound portion This study evaluated a total of 42 individuals who were treated for 30 minutes at an intensity level of 4 during each treatment session There were a total of 3 treatment sessions with 5 7 days interval between sessions The results show that on average a total waist reduction for the entire regimen was 2 0 inches The study included a 4...

Страница 8: ...Shock ONLY Federal law restricts this device to sale by or on the order of a physician CAUTION Make sure the unit is positioned so you can get easy access to the back panel of the unit in case you need to quickly turn the unit off or unplug it 4 INSTALLATION AND SET UP 4 1 Office Conditions The Ultimate Contour should be used in a controlled medical office environment The Ultimate Contour should b...

Страница 9: ...be easily disconnected if needed If needed clean the unit and handpieces as described in Section 6 4 3 Registration Before beginning use of the Ultimate Contour it is highly recommended that you take a moment to register at www ultimate contour com Registration facilitates customer service provides additional infor mation regarding the use of the Ultimate Contour managing patient expectations and ...

Страница 10: ...sistent with the diameter of the handpiece This will help ensure that all of the treatment area is addressed and to help avoid overlapping treatment spots applying excessive energy to a section of tissue which could cause thermal damage Make sure to use a marker that will not get wiped away by the treatment oils but will easily clean off after the treatment Use a tape measure and or skinfold calip...

Страница 11: ...rrently selected The relative power level of the energy The handpiece that is connected to the unit Details about specific differences will be discussed in Sections 5 3 To change the treatment time or the power press the Up arrow to increase the value or the Down arrow to decrease the value Minutes are selected in quantities of 10 minute incre ments from 10 to 40 minutes Intensity is selected at l...

Страница 12: ...u stop the treatment early and then press the Standby button to return to the Standby screen the time will reset to the full amount of time you had selected CAUTION Do not lift up the handpiece during treatment Stop the procedure first before lifting up the handpiece Do not touch the patient with your hands while the handpiece is active When 15 seconds remains in the treatment time the unit will s...

Страница 13: ...th sweeping motion A good analogy to think of is mowing a lawn consistent sweeping patterns that just barely overlap slowly working from one side of the area to the other Apply slight pressure into the skin so the handpiece has a sort of kneading effect on the tissue Most effective results is achieved when folds of skin press up in between the nodes on the handpiece surface Once the entire area ha...

Страница 14: ... and the unit has stopped delivering energy lift the handpiece away from the patient tissue Set the handpiece aside Use clean towels to wipe away excess treatment oil from the skin Assess the treated area There may be some redness or slight swelling of the treatment area Capture post treatment photos of the treated area using the same camera settings as were used for the pre treatment assess ment ...

Страница 15: ... be treated with a disinfection solution such as a 1 3 glutaraldehyde solution or 0 2 peracetic acid solution The handpiece should be visibly wet and remain so for at least 5 minutes You may need to reapply the disinfection solution to achieve this After the five minutes use a new dry towel or cloth to pat dry the handpiece Ensure the handpiece is fully dry before next use After each use look over...

Страница 16: ...ith its accessories excluding the handpieces collectively defined as Product is warranted against defective materials and workmanship for a period of one 1 years from the date of purchase If the Product is leased from Ideal Curves or from any of its authorized distributors consult your lease agreement for the terms and conditions of Product repair and or replacement Repair and or replacement shall...

Страница 17: ... you are having trouble with the Ultimate Contour system have questions regarding its use or need to order replacement parts feel free to contact a customer service representative at Ideal Curves 1 888 861 7211 or at the distributor from whom you obtained the system You may find it quick and helpful to review the Troubleshooting section of this manual Section 8 THIS SECTION INTENTIONALLY LEFT BLAN...

Страница 18: ...ains of a burning sensation Some warmth is normal as this indicates the procedure is working If the heat is intolerable use a lower power setting Also ensure an ample amount of treatment oil is applied to the treatment area Tissues with less adipose tissue may get hotter relative to highly fatty tissue Adjust the power intensity accordingly Treated tissue is red or appears swollen Slight redness i...

Страница 19: ... 0 50 W cm2 1 00 W cm2 Level 3 0 75 W cm2 1 50 W cm2 Level 4 1 05 W cm2 2 00 W cm2 Ultrasound Focal Distance 6mm Ultrasound Focal Distance 6mm Ultrasound Focal Volume 2 12cm3 Ultrasound Entry Power 30 2W Ultrasound Spatial Peak to Temporal Average Intensity 2 01W cm2 Ultrasound Pre Focal Temporal Average Intensity 1 32W cm2 Ultrasound Ratio Peak to Temporal Average Intensity 2 0 Ultrasound Peak Ra...

Страница 20: ...d to take mitigation measures such as relocating or re orienting the equipment Harmonic emissions IEC 61000 3 2 Not available Voltage Fluctuations Flicker emissions Not available The Ultimate Contour is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Guidance an...

Страница 21: ... in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher freq...

Страница 22: ...aration distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 d 3 5 V1 P d 3 5 E1 P GHz d 7 E1 P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 69 3 69 7 39 100 11 67 11 67 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicabl...

Страница 23: ...23 THIS PAGE INTENTIONALLY LEFT BLANK ...

Страница 24: ...Manufactured for Ideal Curves LLC by CAO Group 4628 West Skyhawk Dr West Jordan UT 84084 www ultimate contour com Rev 4 0 Mar 2021 1 888 861 7211 ...

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