35 Jolley Drive Suite 102
Bloomfield, CT 06002
Tel 860.242.2200 Fax 860.242.2212
Informed Consent for TempSure® Wrinkle and Cellulite Treatments
Patient Name: _________________________________________ Date: _______________
Please read this document carefully. Before signing this document, please ask your physician, or the consultant
providing the RF (Radiofrequency) treatment, about any aspect of this document, or the procedure, that you do not
TempSure™ RF System
TempSure™ RF System has been cleared by the FDA for the non-ablative treatment of mild to moderate facial
wrinkles and rhytids on skin phototypes I-VI. All clients are different and exact results of this cosmetic
procedure and treatments cannot be predicted or guaranteed. Three consecutive treatments 3 weeks apart are
recommended for best results of wrinkle treatment. For cellulite treatment, treatments are recommended
once a week for 3 consecutive treatments. Additional “re-touch” treatments are also suggested. Our studies
indicate that greater than 85% of clients still have observable results six months after treatment.
The following are contraindications to the use of TempSure™ RF System equipment. If you have any of the
following conditions, we will not be able to approve TempSure RF treatment for you.
1. Implantable devices or pacemakers.
2. Nerve insensitivity to heat anywhere in the treatment area
3. Pregnancy no studies have been done
4. Autoimmune disease no studies have been done
5. Uncontrolled Diabetes- no studies have been done
6. Active Herpes Simplex no studies have been done
7. Any wound on treatment area will need to heal completely for a month before TempSure RF treatment.
8. Alcohol and drug intoxication- impairs ability to give accurate feedback to medical assistant or
9. Use of regular pain killers, tranquilizers or any medications causing drowsiness or altered mental status
should be avoided the morning of the treatment.
10. Use of blood thinners is a relative contraindication.
Before Treatment:
1. All jewelry and makeup, including lotions, eyeliner and eye shadow should be removed from the
treatment area prior to treatment.
2. Beard stubble should be thoroughly removed prior to treatment as remaining stubble may accentuate
3. Drink at least 80 oz. of water the day before and the day of the treatment.
During Treatment:
You may feel an electric shock similar to a static discharge in a dry environment when the electrode makes
contact or is removed from the skin. A common comparison is the static shock you might feel when touching
something after dragging your feet across carpeting. If the eyelids are to be treated directly, you will have
plastic, non-conductive eye shields covering your eyes.
Informed Consent for TempSure® Wrinkle and Cellulite Treatments - Page 2 of 2
Advance Biomedical Treatment Center
35 Jolley Drive Suite 102 Bloomfield CT 06002
Tel (860)242-2200 Fax (860)242-2212
Slight discomfort may be experienced while undergoing treatment. Typically the discomfort is mild and
temporary during the procedure and localized within the treatment area. During the treatment you will feel
warmth and heat. The skin temperature is automatically determined by the temperature sensor at the tip of
the probe. For benefits to be achieved, skin temperature has to reach 39 C and sustained for at least 3
minutes. Thirty nine degrees centigrade is the temperature considered as high grade fever; it is generally
tolerable. For best results, the medical assistant will try to raise the temperature to 41C. You will be asked to
provide ongoing feedback to the individual performing the treatment. Feel free to let the medical
assistant/physician know if discomfort is reaching intolerable level. There will be no anesthetic (local, oral, or
systemic) used prior to or during the treatment. Additionally, if you have nerve sensitivity to heat anywhere in
the treatment area, you should not be treated. Inadequate or impaired feedback may lead to burns or injury.
To reiterate ongoing feedback should be provided by you to the individual performing the treatment to avoid
excessive discomfort.
After Treatment:
1. Studies indicate the possible side effects of TempSure™ RF System are usually treatment-site related
and include mild discomfort during the procedure.
2. Mild swelling and redness may occur which typically goes away within 2 to 24 hours.
3. Photo-sensitive pigmentation may occur. Diligent protection from sun exposure and application of
sunscreen for two to three weeks after treatment will minimize pigmentation changes.
4. A regimen to moisturize and soothe skin for one week post-treatment is recommended.
5. Drink a minimum of 80 oz. of water a day. Adequate hydration always promotes healthy skin with
fewer wrinkles and less eye bags.
There is the possibility that additional side effects of radiofrequency skin treatments may be discovered in the
future. The use of RF wrinkle treatments in combination with other treatments is unstudied and unknown.
Disclaimer and Consent Form:
1. It has been explained to me that this is a cosmetic procedure and not covered by insurance.
2. It has been explained to me that more than one treatment may be recommended to achieve the best
results and that there are other treatment options such as microdermabrasion, chemical peels, filler
injections, or no treatment at all.
3. As mentioned before, there is no guarantee of results and therefore no refund of payments for the
procedure will be made.
4. While my physician and the staff will take reasonable precautions to ensure my safety, I am willing to
assume the risks of treatment whether known or unknown.
My signature below signifies that all of my questions have been answered by the physician or consultant. I
understand the risks, complications, expected results, and expense of the treatments. I have read and
understood this document and give my consent to receive treatment with the TempSure™ RF System.
Client Name__________________________________________ Date of Birth _______________
Signature____________________________________________ Date Signed ________________
Practitioner Name_____________________________________
Signature____________________________________________ Date Signed ________________