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Thermage Procudure Reference Guideline

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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.
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