Thermage Procedure ® Reference Guide Thermage: Basics Patient Selection Ideal Candidates Not Ideal • Appropriate expectations • Unrealistic expectations • Mild-to-moderate skin laxity • Poor skin quality: - Excessive photo damage. • Crepey or wrinkled skin: - Severe elastosis. - Facelift, blepharoplasty, liposuction, etc. - Poor fibroblast response and elastin production. • Post weight-loss • Poor general / mental health • Post pregnancy • Chronic use of NSAIDS or corticosteroids • Age: 35-60 years old • Severely obese or fluctuating weight Ideal Candidate Examples Contraindications • Pacemaker / Defibrillator / Implanted Electronic Devices / ICD Considerations Moderate jaw line & submental laxity & fullness Moderate nasolabial fold Moderate crow’s feet, fine lines & wrinkles Abdominal laxity & crepiness Medical judgment should be used when treating patients with any of the following conditions. Patient should seek medical advice from a physician if these conditions apply: • Pregnancy • Permanent make-up and tattoos (may treat next to ink border) • For the Thermage Eyes procedure: - Intra ocular eyeshields are not recommended for patients who have had corneal surgery (including Lasik) within the past 6 months. Moderate abdominal fullness & some laxity Moderate fine lines & lack of definition around lips 5 Procedure / Patient Set-up Pre-treatment assessment and planning • Patient does not have any contraindications • Have patient sign consent forms: - A sample consent form is located in the Treatment Form section of this booklet. • Prepare patient record forms: - T reatment record forms for each procedure are located in the Treatment Form section of this booklet. • Remove all topical make-up and / or lotions • Remove all jewelry • Cleanse treatment area thoroughly with soap and water followed with 70% Isopropyl alcohol. • Take before photos: - See specific procedure for details on photo set-up. • Apply return pad: - If lotion has been used in the area the pad is going to be applied, clean with alcohol or water prior to application. - T his is a temporary ink transfer that guides the technician where to treat with the tip. - Grid size should correspond with the tip size being used. - Grid should cover entire treatment area. - Clean skin with 70% Isopropyl alcohol. - While skin is still damp with alcohol, place paper ink side down directly over treatment area. - Dab back of paper lightly with alcohol moistened gauze until the grid shows through the paper. - While paper is still damp, remove it. - See specific procedure for optimal grid location. • Apply a generous amount of coupling fluid to area being treated - Use only Thermage brand coupling fluid. Using substitutes may result in surface burns. - If return pad is not attached, the system will not function. • Inspect the treatment tip for irregularities on the tip surface - Do this throughout the course of treatment, every 50 pulses. - See specific procedure for appropriate pad placement. • Perform treatment • Wear gloves (operator) during patient set-up and treatment • Mark vectors and problem areas while patient is seated or standing 6 • Apply skin marking paper: • Take immediate post photos Treatment Guidelines During Treatment Heat Sensation Feedback Scale • Patient’s feedback on heat sensation is a valid and preferred method for optimal energy selection: - Show feedback scale with 0 - 4 graphic and text for associated sensation to the patient while describing range. - Thermage CPT: To determine patient’s heat tolerance, deliver 5-10 pulses without vibration. • Multiple passes at moderate energy settings yield substantial and consistent efficacy • Treating to a clinical endpoint of visible and/or palpable tightening and contouring maximizes predictability and long-term results • The principle of multiple passes can be used to tighten and contour the entire treatment area as well as defined cosmetic units or treatment zones • Use the pass technique appropriate to the Thermage system and treatment area • Example of pass techniques are on the next page TARGET: 2-2.5 4 INTOLERABLE 3 VERY HOT 2 HOT 1 WARM 0 NOTHING Don’t do that to me again I can take it, but not for long Just starting to feel uncomfortable, but easily tolerable This is very comfortable I don’t feel anything Post Treatment • Clean off grid with alcohol • Take photos of immediate response • Make follow-up appointments for 3 and 6 month photos • Complete chart notes • Optional recommendations: - Discourage use of NSAIDS. - Encourage use of compression garments for body treatments. 7 Pass Technique Options Two Single Passes One Staggered Pass • Most conservative technique: • This is more aggressive and care should be taken. If erythema is persistent, move to another treatment area until it subsides - 1 pass over full grid of squares - 1 pass over full grid of circles 1 4 3 5 6 13 7 14 1 8 11 15 12 16 1st Pulse • R ecommended technique for the Thermage Body Tip 16.0 and the Thermage CPT System • One combined pass of circles and squares, alternating rows: - 1 row of squares 1 2nd Pulse 1 2 3 1 2 3 2 3 4 5 2 6 3 7 2nd Row 4 5 4 1 1st Row 2 2nd Pass One Super Pass 8 1 9 1st Pass - 1 row of circles • One combined pass of circles and squares, alternating: - 1 square then one adjacent circle, then the next adjacent square. 10 2 • Not suitable for use with the Thermage CPT System. It is too aggressive. 3rd Pulse 4th Pulse 5th Pulse Tip Reference Guide Tip Reference Primary Body Part Usage Eye Tip 0.25 Eyes deep depth treatment tips Face Tip 3.0 Face & Neck TT16.00E2 For body shaping and cellulite procedures Total Tip 3.0 Treatment Levels Estimated J/cm2 BODY TIP 16.0 Face, Neck & Body 480.5Thermage 481.0 481.5 CPT482.0 only 482.5 483.0 483.5 484.0 484.5 485.0 485.5 486.0 486.5 487.0 487.5 488.0 488.5 489.0 489.5 25 27 28 29 31 32 33 35 36 38 39 Body Tip Body only TT3.00E2 For3.0 body shape procedures 40 42 43 44 46 47 49 50 BODY TIP 3.0 Treatment Levels Estimated J/cm2 380.5 381.0 381.5 382.0 382.5 383.0 383.5 384.0 384.5 385.0 385.5 386.0 386.5 387.0 387.5 9 12 15 20 27 Body Tip 16.0 32 38 44 50 56 61 Treatment Levels 73 79 85 Body only TT3.00E3 For cellulite procedures Estimated J/cm2 67 CELLULITE TIP 3.0 370.5 371.0 371.5 372.0 372.5 373.0 373.5 374.0 374.5 375.0 375.5 376.0 376.5 377.0 377.5 9 12 15 20 27 32 38 44 50 patient feedback scale 56 61 67 73 4 Intolerable 79 85 Don’t do that to me again 9 Thermage: Face Procedure Tip Selection Thermage CPT® System: TT3.00E4, TT3.00C3 TT3.00E4 : Average starting level is 3.0 TT3.00C3 : Average starting level is 3.0 Thermage NXT System: TT3.00C2, TT3.00C1 TT3.00C2 : Average starting level is 363.0 TT3.00C1 : Average starting level is 353.0 AREA TREATED LOWER FACE LOWER FACE & NECK FULL FACE TOTAL TIP REPs SUGGESTED 600 REPs 900 REPs 900 or 1200 REPs FACE TIP REPs SUGGESTED 600 REPs 900 REPs 900 REPs FULL PASSES 2-4 full passes 5-10 vector passes 2-4 full passes 5-10 vector passes 2-4 full passes 5-10 vector passes PROCEDURE TIME 45-60 minutes 60-90 minutes 60-90 minutes (Thermage CPT only) 13 Treatment Settings Thermage CPT TT3.00E4 For face and body procedures TOTAL TIP 3.0 Treatment Levels 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5 8.0 Estimated J/cm2 7 9 12 14 17 19 22 24 27 30 32 35 38 40 43 46 Thermage CPT TT3.00C3 For face procedures FACE TIP 3.0 Treatment Levels 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5 8.0 Estimated J/cm2 7 9 12 14 17 19 22 24 27 30 32 35 38 40 43 46 Thermage NXT TT3.00C2 For face procedures Treatment Levels Estimated J/cm 2 360.5 361.0 361.5 362.0 362.5 363.0 363.5 364.0 364.5 365.0 365.5 366.0 366.5 367.0 367.5 368.0 368.5 9 12 15 20 27 33 38 44 50 56 61 67 73 79 85 90 96 Thermage NXT TT3.00C1 For face procedures Treatment Levels Estimated J/cm 2 14 350.5 351.0 351.5 352.0 352.5 353.0 353.5 354.0 354.5 355.0 355.5 356.0 356.5 357.5 357.5 358.0 358.5 9 12 15 20 27 33 38 44 50 56 61 67 73 79 85 90 96 Procedure Preparation Supply List Lighting/Photo Set-up • 70% Isopropyl Alcohol • Gauze • Gloves • Skin marking paper • Skin marking pen • Coupling fluid • Return pad • Thermage Total Tip (CPT) or Face Tip (NXT) • Cryogen canister Return Pad Placement • Place return pad horizontally on either side of the upper back Lights • R eturn pad cable connection pointing away from the center of the body and cable pointing away from the treatment area • Equidistant from subject • Diffused with soft box or umbrella • Equally bright • Placed above the subject • Tilted down • Use a black background Camera • Mounted on tripod • Vertical position • Level with patient treatment area 15 Photography Recommendations & Pointers Patient 45 degrees - left and right sides • Head band • Shoulders aligned with direction of gaze • Cape to cover clothing • Check vertical tilt and horizontal rotation of head • No make-up or jewelry • Align tip of nose with edge of cheek for 45 degree angle • Gaze is eye level Photo Positions • Take pictures at five different angles Full front • Head should be level and vertically straight • Shoulder aligned with direction of gaze • Gaze is eye level 90 degrees - left and right sides • Check vertical tilt and horizontal rotation of head • Gaze is eye level 16 Procedure Guidelines Step 1 Pre-treatment assessment and planning • Ask patient to identify areas of concern and treatment goals • Identify areas of treatment for optimal tightening and contouring • M ark vectors (linear patterns of applications) for multiple passes for incremental tightening and contouring - Palpate skin/tissue for mobility, firmness and thickness - Palpate and manipulate to determine the best treatment plan • Mark problem areas for additional passes - Example areas: jowls, submentum, nasolabial folds 17 Procedure Guidelines Optional Vectors Step 2 Use moderate treatment levels • Treat to a level 2.0-2.5 feedback “Hot, but tolerable” - Adjust treatment levels according to patient feedback - T hermage CPT: To determine patient’s heat tolerance, deliver 5-10 pulses without vibration Brow lifting vectors capture skin just below eyebrow. Must have minimum of 5 pulses before returning to first pulse. • Monitor tissue during treatment for excessive erythema (redness) and/or edema (swelling) • Common areas of patient sensitivity shown below Curved swoosh from corner of nose to top of ear. Nasolabial & mesolabial lines Neck lifting vectors • Apply grid to area being treated 18 Jowl lifting vector cross mesolabial line to zygomatic arch. Jawline vector crosses mesolabial line along mandible to ear. Neck vectors midline to just behind angle of jaw. Sensitive Sensitive Areas Areas Sensitive Areas Sensitive Areas Sensitive Areas Sensitive Areas • P enorial region: with dental fillings or crown, it may be more comfortable to place gauze under the lips, over the gums and teeth while treating Procedure Guidelines Step 3 Deliver passes to entire treatment area Vibration with Thermage CPT Handpiece Technique • Start with setting 1, then monitor patient feedback regarding vibration intensity and adjust accordingly (see Basics section for pass technique options) • K eep the treatment tip perpendicular to the skin ensuring full tip-to-skin contact • Use enough downward pressure to maintain full contact, but not so much as to impede vibration • P re-position skin when placing pulses by pulling in the direction of desired contraction Tune Treatment Tip • Select the level of vibration that is most comfortable for the patient • In thin skin areas, a lower vibration setting may be preferred by the patient Choose Treatment Technique (see Basics section) • Two single passes over the entire grid of squares and circles - Penorial region: deliver five single passes across entire grid ­— treat area superior to the vermillion border, extending approximately 1.0 cm laterally to the buccal commissures • Use proper handpiece technique • One Super pass: combined pass of circles and squares, alternating rows • Use a generous amount of coupling fluid • One Staggered pass: combined pass of circles and squares, staggered • Tune on the cheek, avoiding bony areas - Not suitable for treatment with Thermage CPT Coupling Fluid • Repeat chosen technique 2-4 times • Regularly apply generous amounts of coupling fluid • During the treatment, inspect the treatment tip for irregularities on the tip surface, every 50 pulses • Use approximately one 60 mL bottle for a 900 pulse treatment 19 Procedure Guidelines Step 4 Treat vectors and problem areas Step 5 Goal: Treat to a clinical endpoint • Apply additional passes to the vectors and problem areas identified in the pre-treatment assessment • Visual tightening over entire area of treatment • A chieve incremental skin tightening adjacent to and over each area of correction with 2-4 additional passes • Maximize lifting and contouring over each vector with at least 5 additional passes • Use all pulses available • Visual lifting and tightening of selected target areas - Softening of the nasolabial and mesolabial fold - Reduction/narrowing of the jowls - Accentuating or defining of the jaw line - Renewed contour/lift (and/or reduction of submental fullness) • Palpable change • Utilize half-time assessment to identify clinical endpoint Visual Change Untreated Side Palpable Change Treated Side Treated Side Untreated Side 20 Thermage: Eyes Procedure Tip Selection Thermage CPT System: TT0.25NB1 Average starting level is 2.0 Thermage NXT System: TT0.25NB1 Average starting level is 132.0 (See pages 13 & 14 for Thermage Total Tip or Face Tip information) AREA TREATED EYES ONLY EYES & FULL FACE EYE TIP REPs SUGGESTED 450 REPs 450 REPs n/a 900 or 1200 REPs FACE TIP REPs SUGGESTED n/a 600 or 900 REPs FULL PASSES 4-5 passes with Eye Tip 4-5 passes with Eye Tip 2-5 passes with Total Tip or Face Tip PROCEDURE TIME 20-45 minutes 60-120 minutes TOTAL TIP REPs SUGGESTED (Thermage CPT only) 23 Treatment Settings Thermage® CPT 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 24 28 32 36 40 44 48 52 56 60 Thermage NXT 130.5 131.0 131.5 132.0 132.5 133.0 133.5 134.0 134.5 135.0 24 Eyes & Full Face Face Tip 24 28 32 36 40 44 48 52 56 Eyes & Full Face 60 Total Tip (Thermage CPT only) Procedure Preparation Supply List Lighting/Photo Set-up • Plastic ocular shields (Do not use metal shields. They will cause damage to the eye.) • Numbing drops (e.g., Tetracaine or similar) • Lubricant for shield (non-petroleum based) • 70% Isopropyl Alcohol • Gauze • Gloves • Skin marking paper • Cotton tip applicator • Skin marking pen • Coupling fluid • Return pad Lights • Thermage Eye Tip(s) Thermage Total Tip (CPT) or Face Tip (NXT) if needed • Diffused with soft box or umbrella • Cryogen canister • Equally bright Return Pad Placement • Place return pad horizontally on either side of the upper back • R eturn pad cable connection pointing away from the center of the body and cable pointing away from the treatment area • Equidistant from subject • Placed above the subject • Tilted down • Use a black background Camera • Mounted on tripod • Vertical position • Level with patient treatment area 25 Photography Recommendations & Pointers Patient 45 Degrees - Left and Right sides • Head band • Shoulders aligned with direction of gaze • Cape to cover clothing • Check vertical tilt and horizontal rotation of head • No make-up or jewelry • Align tip of nose with edge of cheek for 45 degree angle • Gaze is eye level Photo Positions • Take pictures at three different angles • Take pictures of eyes open and closed in each position • Photograph full face and close up of eyes in each position Full front • Head should be level and vertically straight • Shoulders aligned with direction of gaze • Gaze is eye level • May use chin cup or head restraint, if available 26 Procedure Guidelines Step 1 Pre-treatment assessment and planning Step 2 Insert plastic eye shield • Ask patient to identify areas of concern and treatment goals Thermage does not provide training on the insertion of ocular shields. Practitioners must have prior training on this technique. See shield manufacturer instruction for more user information. • Identify areas of treatment for optimal tightening and lifting - Palpate skin/tissue around eye for mobility, firmness and thickness • Mark vectors (linear patterns) for multiple passes for incremental tightening and lifting • Insert numbing drops into eyes • Apply lubricant to shield • Apply appropriate grid to eyelid and surrounding area • Insert shield into eye 27 Procedure Guidelines Step 3 Use moderate treatment levels • Treat to a level 2.0-2.5 feedback “Hot, but tolerable” Step 5 Treat the surrounding area of the eye with the Total Tip or Face Tip • Monitor tissue during treatment for erythema (excessive redness) and/or edema (swelling) • Keep the treatment tip perpendicular to the skin ensuring full tip-to-skin contact • Common areas of patient sensitivity surrounding eyes shown below • During the treatment, inspect the treatment tip for irregularities on the tip surface, every 50 pulses • Regularly apply generous amounts of coupling fluid • Apply two complete passes • Perform subsequent passes as needed over areas of concern Sensitive SensitiveAreas Areas Step 4 Treat eyelid area with the Eye Tip 0.25 • Perform vector passes as needed for lifting above the eyebrow • Refer to Face section for more information • Keep the treatment tip perpendicular to the skin ensuring full tip-to-skin contact Step 6 Treat to a visible and/or palpable clinical endpoint • During the treatment, inspect the treatment tip for irregularities on the tip surface, every 50 pulses • Visual tightening over entire area of treatment • Regularly apply generous amounts of coupling fluid • Apply two complete single passes; one pass over grid squares and then one pass over intersections of grid squares • Perform subsequent passes as needed over upper and lower eyelids 28 • Visual lifting and tightening of selected target areas - Tightening of the eyelid skin and surrounding areas - Lifting of the eyebrow • Palpable change • Utilize half-time assessment to identify clinical endpoint Thermage: Body Procedure Tip Selection THERMAGE BODY TIP 16.0 Thermage CPT System: TT16.00E2 Average starting level is 3.0 Thermage NXT System: TT16.00E2 Average starting level is 483.0 AREA TREATED Small torso, Under bra areas, Just above knees Average torso, Thighs Arms Large torso, “Love-handles” Buttocks, Larger thighs GRID PAPER 1 Body 16.0 marking paper 1-2 Body 16.0 marking paper 2-3 Body 16.0 marking paper FULL PASSES 2 passes 2 passes 2-3 passes VECTOR PASSES 1-2 vectors 1-2 problem areas 2-3 vectors 2-3 problem areas Multiple vectors Multiple problem areas REPs SUGGESTED 175-250 REPs 250-325 REPs 325 or more REPs PROCEDURE TIME 30-40 minutes 40-50 minutes 50-60+ minutes NUMBER OF PASSES REP COUNTS 1 50 2 100 3 150 4 200 *Using 16.0 skin marking paper Thermage CPT TT16.00E2 For body procedures Treatment Levels 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 9.0 9.5 Estimated J/cm 25 27 28 29 31 32 33 35 36 38 39 40 42 43 44 46 47 49 50 2 Thermage NXT TT16.00E2 For body procedures Treatment Levels Estimated J/cm 2 480.5 481.0 481.5 482.0 482.5 483.0 483.5 484.0 484.5 485.0 485.5 486.0 486.5 487.0 487.5 488.0 488.5 489.0 489.5 25 27 28 29 31 32 33 35 36 38 39 40 42 43 44 46 47 49 50 31 Tip Selection THERMAGE TOTAL TIP 3.0 Thermage CPT System: TT3.00E4 Average starting level is 3.0 THERMAGE BODY TIP 3.0 Thermage NXT System: TT3.00E2 Average starting level is 383.0 AREA TREATED Small torso Under bra areas Just above knees Average torso Thighs Arms Large torso “Love-handles” Buttocks, Larger thighs GRID PAPER 1 large or 2 small marking papers 1-2 large or 2-4 small marking papers 2-3 large or 4-6 small marking papers FULL PASSES 2 passes 2 passes VECTOR PASSES 1-2 vectors 1-2 problem areas REPs SUGGESTED PROCEDURE TIME NUMBER OF PASSES REP COUNTS 1 238 2 476 2-3 passes 3 714 2-3 vectors 2-3 problem areas Multiple vectors Multiple problem areas 4 952 600-900 REPs 900-1200 REPs 1200 or more REPs 45-60 minutes 60-75 minutes 75-120+ minutes deep depth treatment tips Thermage CPT TT16.00E2 For body shaping and cellulite procedures TT3.00E4 For face and body procedures Treatment Levels Treatment Levels2 Estimated J/cm Estimated J/cm2 *Using large skin marking paper BODY TIP TOTAL TIP 16.0 3.0 480.5 481.0 481.5 482.0 482.5 483.0 483.5 484.0 484.5 485.0 485.5 486.0 486.5 487.0 487.5 488.0 488.5 489.0 489.5 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5 8.0 25 27 28 29 31 32 33 35 36 38 39 40 42 43 44 46 47 49 50 7 9 12 14 17 19 22 24 27 30 32 35 38 40 43 46 Thermage NXT TT3.00E2 For body procedures TT3.00E2 For body shape procedures Treatment Levels Treatment Levels Estimated J/cm2 Estimated J/cm2 32 BODY TIP BODY TIP 3.0 3.0 380.5 381.0 381.5 382.0 382.5 383.0 383.5 384.0 384.5 385.0 385.5 386.0 386.5 387.0 387.5 380.5 381.0 381.5 382.0 382.5 383.0 383.5 384.0 384.5 385.0 385.5 386.0 386.5 387.0 387.5 9 12 15 20 27 32 38 44 50 56 61 67 73 79 85 9 12 15 20 27 32 38 44 50 56 61 67 73 79 85 Procedure Preparation Supply List • 70% Isopropyl Alcohol Lighting/Photo Set-up • Gauze • Gloves Umbrella Light Stand (2) • Skin marking paper (large and small sizes) Black Background • Skin marking pen • Coupling fluid • Return pad At belly-button and level • Thermage Total Tip (CPT), Body Tip 3.0 (NXT) and/or Body Tip 16.0 (CPT & NXT) Light stands slightly in front of patient • Cryogen canister Return Pad Placement Abdomen and Buttocks • Place return pad horizontally on either side of the upper back • R eturn pad cable connection pointing away from the center of the body and cable pointing away from the treatment area Lights • Use a black background • Diffused with soft box or umbrella • Equidistant from subject • Equally bright • Umbrellas nearly vertical so light rakes off surface and reveals skin texture • Tilted down Legs and Arms Camera • Place return pad horizontally on either side of the lower back • Mounted on tripod • R eturn pad cable connection pointing away from the center of the body and cable pointing away from the treatment area • Level with patient treatment area • Vertical position 33 Photography Recommendations & Pointers Patient 45 degrees - Left and Right sides • A void wearing clothing that causes skin marks or indentations around the abdomen the day of procedure • Hips and shoulders aligned with feet • Arms behind back and relaxed Example of clothing that will show indentations • Remove pants or pull low enough to not distort treatment area • Wear disposable underwear Photo Positions • Take pictures in five different positions • Camera level with umbilicus Full front • Hips and shoulders aligned with feet • Arms hanging down about 1 foot away from side of body • Focus camera on belly button for abdomen procedure 34 90 degrees - Left and Right sides • Hips and shoulders aligned with feet • Arms behind back and relaxed Procedure Guidelines Step 1 Pre-treatment assessment and planning • Ask patient to identify areas of concern and treatment goals • Mark problem areas by drawing circles • Perform assessment while patient is standing • Mark vectors (linear patterns) for multiple passes for incremental tightening and lifting • Record patient weight and circumferential measurements - Measure at the level of the umbilicus • Identify areas of treatment for optimal tightening and lifting - Pinch and palpate skin/tissue for mobility, firmness, thickness and proclivity - Determine direction of desired contraction and tightening Buttocks Arms Knees & Legs Inner Thighs 35 Procedure Guidelines Step 2 Use moderate treatment levels • Apply grid to area being treated • Treat to a level 2.0­-2.5 feedback “Hot, but tolerable” - A djust treatment levels according to patient feedback - T hermage CPT: To determine patient’s heat tolerance, deliver 5-10 pulses without vibration • Monitor tissue during treatment for erythema (excessive redness) and/or edema (swelling) • Common areas of patient sensitivity - Rib cage area epigastrium - Directly above the pubis area - Adjacent to the umbilicus - Sides of the abdomen - Under arm - Inner thigh Sensitive SensitiveAreas Areas • To help with discomfort pull tissue away from bony prominence or palpate tissue as shown below: 36 Procedure Guidelines Step 3 Deliver passes to entire treatment area Body Tip 16.0: Two Single Passes Handpiece Technique • Keep the treatment tip perpendicular to the skin ensuring full tip-to-skin contact • Use enough downward pressure to maintain full contact, but not so much as to impede vibration • Pre-position skin when placing pulses by pulling in the direction of desired contraction Tune Treatment Tip • Use proper handpiece technique • Use a generous amount of coupling fluid • Tune in fleshy area, avoiding bony prominences Coupling Fluid • Regularly apply generous amounts of coupling fluid • Use approximately one 60 mL bottle for a 900 pulse treatment 1st pass 2nd pass Other Considerations • Tissue should be warm but not hot to the touch with each pass • Treat inferior to superior • Treat medial to lateral • Abdomen procedures – treat 1-2 squares above the treatment area (when using the Total Tip or Body Tip 3.0) Vibration with Thermage CPT (Total Tip 3.0) Step 4 Treat vectors and problem areas • Select the level of vibration that is most comfortable for the patient • Usually a minimum of 4-6 passes over these areas • Start with setting 1, then monitor patient feedback regarding vibration intensity and adjust accordingly • Treat 1-2 rows above the vector or problem area • In thin skin areas, a lower vibration setting may be preferred by the patient • For abdomen treatments: If no problem areas are evident after completing the vector treatment, return to provide additional passes to the upper half of the abdomen Choose Treatment Technique (see Basics section) • Two single passes over the entire grid of squares, and circles • One Super pass: combined pass of circles and squares alternating rows • One Staggered pass: combined pass of circles and squares, staggered - Not suitable for treatment with Thermage CPT or the Body Tip 16.0. • Repeat chosen technique to desired clinical endpoint • During the treatment, inspect the treatment tip for irregularities on the tip surface, every 50 pulses • Use medical judgement with the Body Tip 16.0 Step 5 Treat to visible and/or palpable clinical endpoint • Visual tightening, firming, smoothing and contouring of treated areas • Palpable change • Utilize half-time assessment to identify clinical endpoint 37 Thermage: Treatment Forms These sample forms are provided for your convenience and should be reviewed and edited/supplemented to ensure that their contents comply with your legal and professional requirements. The form should be reviewed periodically to ensure that the contents are current. Solta Medical, Inc. cannot and does not recommend standard operating procedures related to the practice of medicine. Back 3. Location of Return Pad: Apply skin marking grid paper Thigh Pass Technique Treatment Setting min/max Pass Technique Treatment Setting min/max Provider Signature: Comments Take Photos Date Patient Follow-ups Clinician’s Comments: YES Immediate 8. Rate patient discomfort during treatment: 9. Rate erythema immediately post treatment: 10. Rate edema immediately post treatment: YES __ Month LOW No. of Passes No. of Passes NONE No. of REPs 7. Total number of REPs delivered: None Forearm Tx End Time: Exp. Date: Patient’s Sex: M YES __ Month SEVERE Date: Treatment Setting min/max Pass Technique No. of Passes No. of REPs YES __ Month ADDITIONAL TREATMENT ZONES MODERATE Tx Start Time: VECTORS Abdomen Other Date of Treatment: Treatment Tip Lot No.: Patient’s Age: No. of REPs INITIAL PASSES 6. Indicate area treated and treatment settings: 5. 4. Medication: Return Pad (if moved) was moved to Catalog No.: Take pre-treatment photos 2. Treatment Tip Information: 1. Patient’s ID #: Clinician Name: Thermage® Face Procedure Treatment Record F Provider Signature: Comments Take Photos Date Patient Follow-ups Clinician’s Comments: YES Immediate YES __ Month Rate patient discomfort during treatment: Rate erythema immediately post treatment: Rate edema immediately post treatment: Was treatment combined with treatment of other areas of the face? Yes If yes, what areas? Please attach the treatment record form if combined with other areas of the face No SEVERE YES __ Month MODERATE Treatment Setting min/max Treatment Setting min/max LOW Pass Technique Pass Technique NONE No. of Passes Other No. of Passes LEFT EYE Tx Start Time: None Abdomen No. of REPs 7. Total number of REPs delivered: 8. 9. 10. 11. Thigh No. of REPs RIGHT EYE 6. Indicate area treated and treatment settings: Apply skin marking grid paper 4. Medication: 5. Back Treatment Tip Lot No.: Catalog No.: Return Pad (if moved) was moved to 3. Location of Return Pad: Treatment Tip Lot No.: Patient’s Age: Date of Treatment: Catalog No.: Take pre-treatment photos 2. Treatment Tip Information: 1. Patient’s ID #: Clinician Name: Thermage® Eyes Procedure Treatment Record Date: Tx End Time: M YES __ Month Exp. Date: Exp. Date: Patient’s Sex: F Take pre-treatment photos Thigh Apply skin marking grid paper Above the Knee Lower Thighs ______________ Upper Thighs ______________ Abdomen _________________ Upper Arm __________ Decolletage ________________ 9. Indicate area treated and treatment settings: Tx Start Time: 8. 7. Describe where measured: Left Right Inches 6. Pre-treatment measurements Tx End Time: Upper Thighs Lower Thighs __________ Buttocks __________ __________ Upper Arm Exp. Date: Exp. Date: Patient’s Sex: ___________ Not applicable Not applicable Cm None Lbs _______ Other 5. Pre-treatment weight Forearm 4. Medication: Kg _______ Abdomen Treatment Tip Lot No.: Catalog No.: Back Treatment Tip Lot No.: Patient’s Age: Date of Treatment: Catalog No.: Return Pad (if moved) was moved to 3. Location of Return Pad: 2. Treatment Tip Information: 1. Patient’s ID #: Clinician Name: Thermage® Body Procedure Treatment Record M F Contours Skin Laxity Clinician’s Comments 4. Describe where measured: Left Inches Right Lbs _______ 3. Measurements Take photos 2. Weight 1. Patient follow-up - Date Clinician’s Comments 4. Describe where measured: Left Inches 3. Measurements Right Lbs _______ Take photos 2. Weight 1. Patient follow-up - Date Provider Signature: Clinician’s Comments Cm Kg _______ Cm Kg _______ 12. Rate patient discomfort during treatment 13. Rate erythema immediately post treatment 14. Rate edema immediately post treatment Cellulite 11. Conditions Treated / / NONE Not applicable Not applicable Not applicable Not applicable LOW Wrinkles & Rhytids Pass Technique Treatment Setting min/max Pass Technique Treatment Setting min/max Other Date: MODERATE Pass Technique Treatment Setting min/max No. of Passes SEVERE / No. of REPs No. of REPs No. of Passes No. of REPs Focus on Problem Areas Vectors in Targeted Area No. of Passes 10. Technique Used Pulses to Targeted Area Thermage® Body Procedure Treatment Record Thermage: Quick Start Guides 5. Attach a Treatment Tip Press the Treatment Tip into the Handpiece until the tip clicks into position. 4. Connect Return Pad Cable Insert the Return Pad Cable into the Return Pad connection on the System Front Panel. Tighten thumbscrews to secure connection. Insert the Return Pad into the open clip end of the Return Pad Cable. Close the clip lever to secure the Return Pad Cable. 6. Connect Return Pad to Return Pad Cable Insert the Handpiece cable into the Handpiece connection on the System Front Panel. 3. Connect Handpiece 42803A The safe and effective use of RF energy is highly dependent upon factors under the control of the operator. It is important that all warnings, precautions, and the supplied operating instructions be read, understood and followed before use. For further details regarding Thermage CPT System Setup, consult your TG-2B Technical User’s Manual. Open the top cover of the system. Invert, then insert a new cryogen canister into the System Canister Port. Rotate the canister clockwise until hand tight (approximately 3 ½ turns). Plug system into a grounded receptacle, and power ON using the ON/OFF switch (which is on the lower left side of the system). 1 2. Install Cryogen Canister 1. Power System ON System Setup1 Quick Start Guide a. Within 3 seconds, press the Treatment Tip evenly against the skin. b. 1 Replace Coolant Canister promptly to avoid treatment interruption. 42803A User-cleared events (e.g. “Apply Return Pad to patient.”) require operator intervention as described on screen. Self-clearing events (e.g. “Time limit exceeded.”) require very limited or no operator intervention. On screen text turns grey when event has cleared. 9. Self-Clearing & User-Cleared Events NOTE: Treatment may continue for approximately 200 REPs using coolant from the reservoir. b. The system will prompt user when the Coolant Canister is empty. For further details regarding Thermage CPT System Operation, consult your TG-2B Technical User’s Manual. The Tip Summary screens can be accessed between treatment cycles by pressing the [CONTINUE] button. The summary provides real time feedback on parameters such as average treatment level and elapsed treatment time. During treatment, the System Mode (e.g. TUNING) will appear in the upper left corner of the system display. Corresponding instructions may appear in the middle of the system display. Press [CONTINUE] to select the desired level, and resume treatment. c. 8. Treatment Tip Summary Use the + and – buttons to adjust the treatment level. b. 7. System Modes To end the treatment cycle, release the activation switch and lift tip from treatment area. Begin by pressing the activation switch (Fingerswitch or Footswitch). a. Press [ADJUST] button. a. This system and its dedicated tips have an enhanced heating profile which can result in more uniform heat delivery and elevated bulk tissue temperature with fewer pulses. Please treat accordingly. 6. Cooling Module 5. Changing Treatment Settings 4. Deliver RF Energy Use the Vibration Button on Handpiece to adjust the vibration intensity to the desired level. Press once for LOW, twice for MEDIUM, and three times for HIGH. Pressing a fourth time will turn it OFF (these settings are designated on the LCD as 1, 2, 3, and 0, respectively). Use the + and – buttons to adjust the treatment level. Press [CONTINUE] to select. Deliver tuning pulse to targeted treatment area. 3. Select Vibration Level (TH-4 Handpiece only) 2. Select Treatment Level 1. Tune System System Operation1 Quick Start Guide 6. Connect Return Pad to Return Pad Cable Insert the Return Pad into the open clip end of the Return Pad Cable. Close the clip lever to secure the Return Pad Cable. 5. Connect Return Pad Cable Insert the Return Pad Cable into the Return Pad connection on the System Front Panel. 4. Attach Treatment Tip Press the Treatment Tip into the Handpiece until the tip clicks into position. 3143A The safe and effective use of RF energy is highly dependent upon factors under the control of the operator. It is important that all warnings, precautions, and the supplied operating instructions be read, understood and followed before use. For further details regarding ThermaCool® TC3 System Setup, consult your TG-1A Technical User’s Manual. Power ON the Cooling Module using its ON/OFF switch on the back of the unit. Change the Cryogen Canister if necessary. Plug the Generator into a grounded receptacle. Then power ON the system using the ON/OFF switch located on the power entry module on the rear panel. When the Generator is ready for use you will hear a continuous five (5) second tone. Place the handpiece in holster, with treatment tip end pointing down. Attach all four (4) handpiece cables to the RF generator as follows: • Red-sleeved cable to “RF+” • Blue-sleeved cable to “RF-“ • Black power cable to “HP Power” (align cable dots at the 3 o’clock position) • 2-Pronged HP COMM cable to the “HP COMM” port Plug the handpiece tubing connector into the Cooling Module 1 3. Power Cooling Module ON 2. Power System ON 1. Connect Handpiece System Setup1 Quick Start Guide Press [CONFIRM] to select the desired level. Press [START/STOP] button to enter READY mode and resume treatment. c. d. 1 The FAULT mode indicates unrecoverable events that require a System Reset. A fault tone sounds, an error message is displayed, and the Fault indicator illuminates. The System must be powered OFF and back ON to exit the FAULT mode. The ERROR mode indicates recoverable, usercleared events (e.g. “Apply Return Pad to patient.”) that require operator intervention as described on the Status display. An error tone sounds and an error message is displayed. Press the START/STOP button to exit the ERROR mode. 3143A The safe and effective use of RF energy is highly dependent upon factors under the control of the operator. It is important that all warnings, precautions, and the supplied operating instructions be read, understood and followed before use. For further details regarding ThermaCool TC3 System Setup, consult your TG-1A Technical User’s Manual. To end the treatment cycle, release the activation switch and lift tip from treatment area. Within 3 seconds, press the Treatment Tip evenly against the skin. c. Turn the treatment level knob (clockwise to increase). b. “Arm” the handpiece by pressing the fingerswitch (or optional footswitch). b. The ALARM mode indicates recoverable events that require very limited or no operator intervention. An alarm tone sounds and an error message is displayed in the Status display. Release the fingerswitch and/or terminate tissue contact to exit the ALARM mode. Press [START/STOP] button to enter STANDBY mode. a. Hold the handpiece above the treatment site in a vertical position. a. 6. System Generator Modes 5. Changing Treatment Settings 4. Deliver RF Energy Apply a generous amount of Thermage Coupling Fluid to the target treatment area prior to delivery of RF energy. Press the START/STOP button on the System Front Panel to Enter the READY mode. The green “Ready” light will illuminate on the handpiece when it is ready to treat. In STAND-BY mode, adjust the treatment level by turning the treatment level knob (clockwise to increase). Press [CONFIRM] to select. 3. Apply Coupling Fluid 2. Enter READY Mode 1. Fine Tuning & Treatment Level Selection System Operation1 Quick Start Guide Indications for use include the non-invasive treatment of wrinkles and rhytids, including the upper and lower eyelids, and for the temporary improvement in the appearance of cellulite. MK 3118B © 2013 Solta Medical, Inc. All rights reserved. Thermage and Solta Medical are trademarks or registered trademarks of Solta Medical, Inc. or its subsidiaries. Other names and brands may be claimed as the property of others.