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Chapter 2 - Safety precautions and safety features 2.3. Precautions 1. This device is designed to contour the body by removing localized deposits of excess fat through small incisions in male and female adults. 2. Safety and effectiveness in pregnant woman and children have not been established. 3. Use of this device is limited to those physicians who, by means of residency training or sanctioned continuing medical education, have demonstrated proficiency in suction lipoplasty. 4. Results of this procedure will vary depending upon patient age, surgical site, and experience of the surgeon. 5. Results of this procedure may or may not be permanent. 6. The amount of fat removed should be limited to that necessary to achieve the desired cosmetic effect. 7. All reusable components of the device must be sterilized and all disposable components replaced before using the device on another patient. 8. If the vacuum regulator does not regulate the vacuum pressure properly, or if the suction cannula and tip are not of appropriate size, shape and rigidity, this might result in tissue damage. 2.4. Compliance with safety information Appropriate application of and compliance with the safety information considerably contributes to the safety of the user, of the patients and the environment. Human Med AG ® User manual body-jet evo Doc-No.: 900061 Rev./ Date: 0/ 17.01.2013 Page 2-3