TREATMENT REFERENCE GUIDE

This reference guide does not replace the Cellfina™ Instructions for Use (IFU). Please reference the IFU for
additional information.

Copyright
© 2015 Ulthera, Inc. Cellfina is a trademark of Ulthera, Inc. in the United States and other countries.

Disclaimer
This Treatment Reference Guide was current when it was published. Every reasonable effort has been made to
assure the accuracy of the information within these pages. The ultimate responsibility lies with readers to ensure
they are following the applicable procedures and guidelines correctly. Merz employees, agents and staff make no
representation, warranty, or guarantee that this compilation of information is error-free, and will bear no responsibility
or liability for the result or consequences of this course. This Treatment Reference Guide is a general summary and
explains procedures, principles and guidelines for the proper use of the Cellfina™ System.
The Cellfina System is intended for long-term improvement in the appearance of cellulite in the buttocks and thigh
areas of adult females. Safety and effectiveness in other anatomical areas have not been established. The most
common side effects reported were soreness, tenderness, and bruising. The Cellfina System is only available through
a licensed physician. For full product and safety information, visit Cellfina.com/IFU.

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CELLFINA TREATMENT OVERVIEW
™

Photographs Patient Marking Patient Preparation

Anesthesia Delivery Tissue Release & Post-Treatment Care

1
 CELLFINA COMPONENTS
™

Setting Up for a Cellfina™ Treatment

Prior to beginning a Cellfina™ Treatment, set up all components.

1 Perform the following 2 Peel back paper
prior to sterile setup:
Insert the Disposable
Liner into the 1.5 L
canister.
Remove yellow
tubing connector,
insert into hole on
the Disposable
Liner Lid.
3 While maintaining 4 Affix the Anesthesia
cover; do not touch sterility, remove
or contaminate the inner tray and place
inner sterile tray. on sterile field.
Discard tray lid.
5 Insert and lock
Needle firmly to Anesthesia Guidance
the luer of the Platform tabs
Anesthesia Handle, into the Vacuum
ensuring the side Handpiece. Connect
holes of the needle lid, with the 6 mm
are horizontal. side facing up.
CAUTION: For your
safety, sheath should
remain on needle
until use.

2
6 Connect sterile 7 During sterile setup, 8 Unwrap sterile Motor 9 Place Motor Module 10 Attach the Motor
Vacuum Tubing to attach blue connector Module cover, invert cover over the Module to the Micro-
port on the Vacuum end of the Vacuum on fingers of one disinfected Motor Blade Assembly.
Handpiece. Tubing to the yellow hand. Module, ensuring CAUTION: For your
connector port on cover does not safety, sheath should
the Disposable wrap below the remain on Micro-
Liner Lid. bottom edge. Blade until use.

3
 CELLFINA COMPONENTS (CONTINUED)
™

Setting Up for a Cellfina™ Treatment

11 Power on/off to verify 12 Unwrap paper ties 13 Connect clear 14 Connect the tubing
blade reciprocates. from the two Fluid Anesthesia Tubing to from the Anesthesia
Delivery Syringe open luer. Handle to the Fluid
CAUTION: For your
Tubings. Delivery Syringe
safety, keep fingers
and hands away from Tubing.
reciprocating blade
while Motor Module
is on.

4
15 Sterile person hands 16
off tubing spike for
non-sterile person
to spike IV Bag. Pull
back on Fluid Delivery
Syringe Plunger to start
flow of IV solution.
Depress the Fluid 17
Delivery Syringe
Plunger and repeat
until all air is expelled
and tubing is primed
with the anesthesia
fluid.
Note: Tubing to remain
primed at all times.
Ensure Suction Pump
and all connections are
in working order.
Ensure Foot Vacuum
Regulator Pedal is
connected.
Power on the Suction
Pump to test.
5
 PATIENT PHOTOGRAPHY
Photography Positions
Photograph patient in standing position under downward lighting in at least 5 positions (posterior, left and right
profiles, and left and right oblique).

Left profile Left oblique Posterior Right oblique Right profile

Consistent positioning and lighting is key to effective Cellfina™ photographs:

• Camera mounted approximately 29" above the floor and 61" from the patient.
• Light source angled 30 degrees downward towards the patient.
• The downward lighting aids in the identification and marking of cellulite by casting shadows in the
cellulite dimples and depressions.
• Include photographs of the anterior thigh if cellulite is present.

6
PATIENT MARKING
Marking Technique
• Use a water-resistant surgical marking pen.
• Mark patient in same positions under same
lighting as for the photographs.
• Use the photographs to aid in cellulite
identification and marking.
A circle or oval identifies distinct
cellulite dimples.
Straight lines mark linear cellulite
depressions.
A hatched mark identifies a cellulite
depression within a longer line.

These examples show

a current marking best
practice. The most
important element is to
have a consistent way to
mark all treatable cellulite.

7
 PATIENT TREATMENT
Cellfina™ Preparation
• Prior to every procedure, confirm that the
Cart and Suction Pump are clean and in
working order.
• The Motor Module and Power Supply should
be cleaned and disinfected before and
after each treatment by wiping the external
surfaces with a standard germicidal wipe
per institutional standard practice for the
recommended exposure time. See the
Cellfina™ Instructions for Use for information
on the manual cleaning procedure.
• Ensure there is a Disposable Kit and Prep
Pack for each patient.

8
ANESTHESIA DELIVERY
1 Prep the patient with a disinfecting surgical scrub.
2 Turn on the Suction Pump. Set to approximately
40 kPa.
3 Confirm that the Anesthesia Guidance Platform is
locked into Vacuum Handpiece and the lid is set at
the 6 mm depth.
4 Place the Vacuum Handpiece on the first area to be
anesthetized.
5 Activate the suction with the Foot Pedal, ensuring
that the tissue is fully acquired into the Vacuum
Handpiece.
8 Slide the needle assembly laterally to the furthest
6 Remove the protective sheath from the Anesthesia delivery track and advance to the end.
Needle.
9 Deliver 6–8 cc of anesthetic solution, as per
7 Insert the guidepin on the needle assembly into the physician discretion.
entry track of the Guidance Platform, advancing to
the hard stop.

9
 ANESTHESIA DELIVERY (CONTINUED)
10 Retract the needle assembly and slide laterally to
the second delivery track. Advance to the end and
deliver a second bolus of anesthesia.
11 Repeat for all four delivery tracks.
12 Remove the needle assembly from the Guidance
Platform.
13 Use the Foot Pedal to release the suction. For
patient comfort, insert a finger between the Vacuum
Handpiece and the patient’s skin to release the
vacuum and more easily remove the Vacuum
Handpiece.
14 Reposition the Vacuum Handpiece and repeat the
process until the full treatment area is anesthetized.
– Whenever possible, position the Vacuum
Handpiece so that the needle enters the patient
through previously anesthetized areas.
– Ensure the anesthesia has generous borders
around the treatment area to promote patient
comfort.
15 Allow 10–15 minutes of dwell time for the
anesthesia to take effect.

10
TREATMENT STRATEGY
There are 4 elements involved
in treatment strategy:
1 Determining the Guidance
Platform (rectangle or
teardrop).
2 Identify a partial or complete
release.
3 Assess the release depth
(6 or 10 mm).
4 Decide the optimal
orientation of the Vacuum
Handpiece.
Determining which Guidance Platform to Use
5 tracks
Narrow
width
Rectangle
• Most commonly used platform.
Its narrow release area minimizes
the cutting of tissue.
• There are 5 tracks on the
rectangle platform.
• Use on buttocks and thighs.
4 tracks
Wide
width
Teardrop
• Wider orientation enables larger
release area for capturing clusters
of dimples or longer depressions
(less commonly used).
• There are 4 tracks on the teardrop
platform.
• The teardrop is not commonly
used on the thighs.
11
 TREATMENT STRATEGY (CONTINUED)
Identify a Partial or Complete Release
The release is determined by the number of tracks on the
Guidance Platform required to release the septae band(s).

Each track corresponds with the position of the blade, P4 C

P2 P3
which is indicated on the lid of the Vacuum Handpiece. P1

When the Micro-Blade Assembly does not travel through

all the tracks on the platform, it is a partial (P) release.

• P1 is the first track only.

• P2 is the first two tracks.
• P3 is the first three tracks.
• P4 (rectangle only) is the first four tracks. P3 C
P1 P2
Moving through all the tracks is a complete (C) release.
Partial releases are preferable to minimize the cutting of tissue.

12
Assess the Release Depth
(6 mm or 10 mm)
The reversible lid determines treatment depth of
either 6 or 10 mm.
• 6 mm is the default treatment depth.
• 10 mm is used to avoid connecting adjacent
sites at the same depth or to release deeper
cellulite dimples. 01 6

Decide the Optimal Orientation of

the Vacuum Handpiece
• On the buttocks, orient the Vacuum Handpiece
for partial releases when possible.
• On the thighs, use a vertical orientation.
• For patient comfort, orient the Vacuum
Handpiece to release within the
anesthetized area.

13
 TREATMENT
1 Turn on the Suction Pump to approximately 40 kPa.
2 Confirm that the desired Guidance Platform is
connected to the Vacuum Handpiece and the lid is
set for the desired depth.
3 Place the Vacuum Handpiece on the patient. For
patient comfort, begin treating in the first area that
was anesthetized.
4 Activate the suction with the Foot Pedal, ensuring
the tissue is fully acquired into the Vacuum
Handpiece.
5 Remove the protective sheath from the Micro-
Blade.
6 Insert the blade assembly guidepin into the entry
track of the Guidance Platform, advancing to the
hard stop.
7 Turn on the Motor Module.
8 Slide the blade assembly laterally through the
guidance track.
14
9 If performing a P1 release, turn the Motor Module
off on the lateral side of the Guidance Platform. If
more tracks are required, leave the Motor Module
on and advance the blade assembly to the next
track(s). Slide laterally through each desired track(s).
Always turn the Motor Module off on the lateral
side of the Guidance Platform (example Left-Right-
Off). Never retract the blade assembly with the
Motor Module on.
10 Remove the blade assembly from the Guidance
Platform.
11 Use the Foot Pedal to release the suction of the
Vacuum Handpiece. For patient comfort, insert a
finger between the Vacuum Handpiece and the
patient’s skin to release the vacuum and more easily
remove the Vacuum Handpiece.
12 Reposition the Vacuum Handpiece and repeat the
process until all marked areas are released.
SAFE TREATMENT TECHNIQUES
Avoiding Damaged Blades
When performing a Cellfina™ Treatment, it is vital to turn the Motor Module
OFF on the lateral side of the Guidance Platform after the final release for OFF on OFF on
either side either side
each treatment area and prior to retracting the blade from the tissue within prior to prior to
the Vacuum Handpiece. If the Motor Module is not turned off, the blade returning to Left Right returning to
the center of the center of
continues to reciprocate as it exits the patient, causing the blade tip to hit the the platform the platform
after the after the
hard plastic on either side of the septum. This will bend or damage the blade. final release final release

If a blade Do NOT attempt to repair the blade. Do NOT try to use a bent or damaged blade.
does become • The Cellfina blade is an extremely sharp, • Blade may not perform as intended, resulting
damaged or multi-faced blade. in reduced procedure efficacy.
bent: • User is risking a laceration by touching the • Damaged blade may pose risk to patient.
blade. Follow proper Sharps Safety Protocol. • A distorted blade may damage the septum,
• The blade may become damaged or resulting in loss of vacuum during the
distorted if repaired. procedure.

In the case of a bent or damaged blade, a new Cellfina Blade Assembly

must be used to replace the damaged/bent blade.

15
 SAFE TREATMENT TECHNIQUES (CONTINUED)
Cleaning, Disinfecting, and Device Disposal
The Motor Module and Power Supply should be
cleaned and disinfected before and after each
procedure by wiping the external surfaces with a
standard germicidal wipe per institutional standard
practice for the recommended exposure time.
Never submerge or spray fluids on the Motor Module
and Power Supply directly.
Periodically inspect the Motor Module and Power
Supply (including cords) for visible damage.
The Anesthesia Needle Assembly and Micro-Blade
Assembly should be disposed of per standard
institution or facility biohazard sharps disposal practice.
The Vacuum Handpiece and all other accessories
should be disposed of per standard institution or
facility biohazard practice. Do not reuse the Anesthesia
Needle, Micro-Blade or Vacuum
Handpiece Assemblies.

For full product information, refer to the Cellfina™ Instructions for Use.

16
POST-TREATMENT CARE
The following are post-treatment care best practices:
• Cleanse the treated area.
• Express fluid:
– Apply pressure to the treated area on the buttocks
and thighs to express excess anesthetic fluid.
• Bandage:
– Apply sterile absorbent bandages to the treatment
site and secure with surgical tape.
• Compressive type garments:
– Compressive type garments should be worn as often
as possible for the first two weeks post-treatment.
• Activity:
– Light physical activity is allowed in the first 30 days,
but extreme physical activity should be avoided
during this time.

For more detailed information, refer to the Cellfina™

Instructions for Use.

17
 ADDITIONAL SUPPLIES
In addition to the standard Cellfina™ components, note the following supplies may be required or needed.

• Disposable waterproof medical pads • 0.9% Normal Saline (NS) IV bags

(minimum 500 cc per patient)
• Sterile 4x4 gauze
• Physician compounded anesthetic solution
• Surgical scrub solution
• Sterile ABD pads
• Sterile drapes
• Surgical tape
• Sterile scissors
• Compressive type garments
• Water resistant surgical markers
• Absorbent disposable underwear
• Fine tip red and black marker
• Blanket and pillow for patient comfort
• Sterile gloves

18
NOTES

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© 2015 Ulthera, Inc. All rights reserved.
www.cellfina.com 1006035TRN Rev A