Ulthera DeepSEE DS 4 - 4.5 User manual

Ulthera, Inc. Page 1
Ulthera®System
Instructions for Use
Featuring DeepSEE®Technology for Ultherapy®

Page 2Ulthera, Inc.
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Ulthera, Inc. Page 3
02-2021
Published in the USA
CAUTION: UNITED STATES FEDERAL LAW RESTRICTS THIS DEVICE TO SALE
BY OR ON THE ORDER OF A PHYSICIAN.
THE ULTHERA® SYSTEM IS INTENDED FOR USE ONLY BY PROPERLY TRAINED
PHYSICIANS AND PROPERLY TRAINED PERSONS UNDER THE SUPERVISION
OF SUCH A TRAINED PHYSICIAN (HENCEFORTH “THE USER”).
PRIOR TO OPERATING THE SYSTEM, THE USER MUST THOROUGHLY READ
AND UNDERSTAND THIS MANUAL. IMPROPER USE OF THE SYSTEM MAY
CAUSE PE R SONAL INJ UR Y AND/OR DAM AGE TO TH E S YSTE M TH AT MAY
INVALIDATE TH E W AR R ANTY AGR E E ME NT.

Page 4Ulthera, Inc.
© 2020, Ulthera, Inc. All Rights Reserved. The trademarks ULTHERA®,
ULTH E R APY®, and DEEPSEE®are registered in the United States and/or
internationally. The Ulthera®System DeepSEE®technology is covered by
patents identified at www.merzusa.com/patents. More than 200 other U.S.
and International patents to which Ulthera has rights are issued, published, or
pending.
This manual may not be copied, translated, or reproduced in whole or in part
without the express written consent of Ulthera, Inc.

Ulthera, Inc. Page 5
Table of Contents
1. Introduction to Manual ..........................................................................................7
1.1. Purpose ...........................................................................................................7
1.2. Conventions....................................................................................................7
2. Medical Safety.........................................................................................................8
2.1. Indications for Use........................................................................................... 8
2.2. Contraindications........................................................................................... 8
2.3. Precautions..................................................................................................... 8
2.4. Patient Safety..................................................................................................9
2.5. Potential Side Effects....................................................................................10
2.6. Complaints and Adverse Even ts.................................................................. 11
2.7. Post- Market Surveillance.............................................................................12
3. System Overview...................................................................................................13
3.1. System Description........................................................................................13
3.2. System Components and Features.............................................................. 13
3.3. System Specifications................................................................................... 18
4. System Safety .........................................................................................................21
4.1. Electrical and Fire Safety.............................................................................. 21
4.2. Equipment Use and Care.............................................................................22
4.3. Ergonomic Safety ......................................................................................... 22
4.4. Medical Ultrasound Safety........................................................................... 22
4.5. Electromagnetic Compatibility and Immunity............................................ 25
4.6. Disposal ......................................................................................................... 29
4.7. Safety Symbols..............................................................................................30
5. Setting Up for First-Time U se .................................................................................32
5.1. Unpacking.....................................................................................................32
5.2. Physical Environment....................................................................................32
5.3. Electrical Requ irements................................................................................ 33
5.4. Connecting Components............................................................................33
6. Treatment Guidelines ...........................................................................................35
6.1. Preset Guidelines and Energy Levels........................................................... 35
7. System Operation..................................................................................................43

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7.1. Ulthera System Access Key ..........................................................................43
7.2. User Interface................................................................................................ 43
7.3. Operating Instructions.................................................................................. 49
7.4. Adjunctive Functions....................................................................................55
7.5. Troubleshooting ............................................................................................ 59
8. System Messages...................................................................................................61
9. Cleaning and Care...............................................................................................65
9.1. Cleaning the Transducer and Handpiece.................................................. 65
9.2. General Care of the System ........................................................................ 65
10. Re-order Information ............................................................................................67
11. Safety Standards and Regulatory Classifications............................................ 68

Ulthera, Inc. Page 7
1. Introduction to Manual
1.1. Purpose
This Instructions for Use manual provides a description of the System
components, its controls and displays, instructions for its operation, and other
equipment information important to the user.
W arning: Do NOT operate the Ulthera System before reading this
manual thoroughly. Clinical training with additional materials are
available by the Company or your local distributor. For more information
on training available please contact your local representative.
1.2. Conventions
Note: Notes designate information of special interest.
Caution: Cautions alert the user to precautionary steps necessary to
properly operate the system. Failure to observe these cautions may void
the warranty.
Warning: Warnings alert the user to information that is of the highest
importance and vital to the safety of the patient and user.
All procedures are broken down by numbered steps. Steps must be
completed in the sequence they are presented.
Bulleted lists indicate general information about a particular function or
procedure. They do not imply a sequential procedure.
Control names are spelled as they are on the system, and they appear in
Bold text.

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2. Medical Safety
2.1. Indications for Use
The Ulthera System is indicated for use as a non-invasive dermatological
aesthetic treatment to:
•Lift the eyebrow
•Lift lax submental (beneath the chin) and neck tissue
•Improve lines and wrinkles of the décolleté
The Ulthera System, in conjunction with the Ulthera DeepSEE transducer,
allows for ultrasonic visualization of depths up to 8 mm below the surface of
the skin. The indicated use of the imaging is to visualize the dermal and
subdermal layers of tissue to:
•Ensure proper coupling of the transducer to the skin
•Confirm appropriate depth of treatment such as to avoid bone
2.2. Contraindications
The Ulthera System is contraindicated for use in patients with:
•Open wounds or lesions in the treatment area
•Severe or cystic acne in the treatment area
•Active implants (e.g., pacemakers or defibrillators), or metallic implants in
the treatment area
2.3. Precautions
When not in use by trained personnel, the Ulthera System Access Key should
be removed from the system to help prevent unauthorized use. Keep the
Ulthera System Access Key in a designated place accessible only to
authorized and trained personnel.
The Ulthera System has not been evaluated for use over various materials.
Therefore, treatment is not recommended directly over those areas with any
of the following:
•Mechanical implants
•Dermal fillers
•Breast implants
Treatment energy is not recommended for use directly on an existing keloid.

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The Ulthera System has not been evaluated for use in patients on an
anticoagulant treatment plan.
It is recommended that the following areas should be avoided during
treatment:
•Thyroid gland, thyroid cartilage and trachea
•Major vessels
•Breast tissue or breast implants
The Ulthera System has not been evaluated for use in the following patient
populations:
•Pregnant or breast feeding women
•Children
•Those with the following disease states
oA hemorrhagic disorder or hemostatic dysfunction
oAn a ct i ve systemic or local skin disease that may alter wound
healing
oHerpes Simplex
oAutoimmune Disease
oDiabetes
oEpilepsy
oBell’s Palsy
2.4. Patient Safety
Warning: Ulthera should not be used on a patient’s eyes or in a location
or technique where ultrasound energy can reach the eye.
Warning: Use this system only if you are trained and qualified to do so.
W arning: If any problems occur during system operation, take
immediate action(s): lift the transducer off the patient’s skin, press the
See pushbutton on handle to discontinue treatment in progress, and/or
press the red emergency Stop button to completely halt system
operation.

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2.5. Potential Side Effects
Side effects reported in the clinical evaluation of the Ulthera System for the
brow, submental (under the chin) area and neck treatment(s) were mild and
transient in nature. These were limited to:
•Erythema (redness): The treated area may exhibit erythema immediately
following treatment. This typically resolves within a few hours of treatment.
•Edema (swelling): The treated area may exhibit mild edema following
treatment. This typically resolves within 3 to 72 hours of treatment.
•Welting: The treated area may exhibit a localized area of linear visible
edema following treatment. This typically resolves within a week.
•Pain: Momentary discomfort may be experienced during the procedure
while energy is being deposited. Post procedure discomfort typically
resolves within 2 hours and 2 day. Tenderness to the touch is also possible
and typically resolves within 2 days to 2 weeks of treatment.
•Bruising: Mild bruising, which is caused by damage to soft tissue blood
vessels, may occur occasionally and typically resolves within 2 days to 2
weeks of treatment.
•Nerve Effects:
oTransient local muscle weakness may result after treatment due to
inflammation of a motor nerve. This typically resolves in 2 to 6 weeks
of treatment.
oTransient numbness may result after treatment due to inflammation
of a sensory nerve. This typically resolves in 2 to 6 weeks of
treatment.
oTransient pain, paresthesia and/or tingling may be experienced.
This typically resolves in 2 to 6 weeks of treatment.
No permanent injuries to facial nerves were reported during clinical trials.
•Burns/Scarring: The possibility for burns, which may or may not result in
permanent scar formation, may occur if incorrect treatment technique is
used (e.g. tilting transducer, incorrect line spacing, gel pockets, etc. see
section 7.3.4 & 7.3.5). Some scars may respond to medical treatment and
resolve fully.
Side effects reported in the clinical evaluation of the Ulthera System for the
décolleté treatment were mild and transient in nature. These were limited to:
•Erythema (redness): The treated area may exhibit erythema immediately
following treatment. This typically resolves within a few hours of treatment.
•Edema (swelling): The treated area may exhibit mild edema following
treatment. This typically resolves within 3 to 48 hours of treatment.
•Pain: Momentary discomfort may be experienced during the procedure
while energy is being deposited. Post procedure discomfort typically

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resolves within 2 hours and 2 day. Tenderness to the touch is also possible
and typically resolves within 2 days to 2 weeks of treatment.
•Welting: The treated area may exhibit a localized area of linear visible
edema following treatment. This typically resolves within 1 day to 3 weeks
of treatment.
•Raised area of edema: The treated area may exhibit a localized area of
linear visible edema following treatment. This typically resolves within 1
day to 3 weeks of treatment.
•Bruising: Mild bruising, which is caused by damage to soft tissue blood
vessels, may occur occasionally and typically resolves within 3 days and 3
weeks of treatment.
•Transient Sensory Nerve Effects (as a result of inflammation of the nerve):
oParesthesia and/or numbness may be experienced and typically
resolves within 4 days to 5 weeks of treatment.
oTingling may result after treatment and typically resolves within 3 to
5 days of treatment.
oItching may result after treatment and typically resolves within 1 to
3 weeks of treatment.
No permanent nerve injuries were reported during clinical trials.
•Burns/Scarring: The possibility for burns, which may or may not result in
permanent scar formation, may occur if incorrect treatment technique is
used (e.g. tilting transducer, incorrect line spacing, gel pockets, etc. see
section 7.3.4 & 7.3.5). Some scars may respond to medical treatment and
resolve fully.
2.6. Complaints and Adv erse Ev ents
No serious adverse events were observed during the clinical study evaluation
of the Ulthera System.
Ulthera follows MDR (Medical Device Reporting) rules for handling complaints
and adverse events. Should an adverse event be suspected or reported,
contact Ulthera, Inc. at the number on the back page of this document; for
those outside the U.S., contact your local Ulthera representative.

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2.7. Post- Market Surveillance
The following adverse events have been identified during routine clinical use
following FDA clearance (post market) of the Ulthera system. Because they
are reported voluntarily from a population of uncertain size it is not always
possible to reliably estimate their frequency or establish a causal relationship
to the Ulthera system. These events have been chosen for inclusion due to a
combination of their seriousness, frequency of reporting, or potential causal
connection to the Ulthera system: pain,burns, or burning sensation, edema /
swelling, nodules, bruising, fat / volume loss, neuropathy, numbness,
paresthesia, palsy, paresis, speech difficulty, muscle weakness, headache,
migraine, visual change, skin sagging / drooping, asymmetry, erythema,
welts, hives, rash, urticaria, pruritus, blistering, scarring, discoloration and
hyperpigmentation.

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3. System Overview
3.1. System Description
The Ulthera System integrates the capabilities of ultrasound imaging with
those of ultrasound therapy.
The imaging feature allows the user to visualize the skin and sub-dermal
regions of interest before treatment. It also allows the user to assure proper
skin contact in order to deliver the energy at desired depths.
The therapy feature directs acoustic waves to the treatment area. This
acoustic energy heats tissue as a result of frictional losses during energy
absorption, producing discrete points of coagulation.
3.2. System Components and Features
The Ulthera System consists of three primary components: the control unit
with integrated touchscreen, the handpiece with cable, and
interchangeable transducers (see Figure 3.1).
Figure 3.1 Main components of the Ulthera® System: Control Unit (top), Handpiece (bottom
right), Image/Treat Transducer (bottom left) that inserts into the handpiece receptacle.

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3.2.1. Control Unit
The control unit is the tabletop information center for the Ulthera System. It
houses the touchscreen monitor and Graphical User Interface (GUI) that
allows the user to interact with the device. This screen sets and displays the
operating conditions, including equipment activation status, treatment
parameters, system messages and prompts, and ultrasound images. Figure
3.2 illustrates the physical features of the control unit, such as the various
connector ports and power controls.
Figure 3.2 Control Unit front v iew (left) and rear v iew (right).
See Table 3.1 for a description of the controls and connector ports of the control unit.
Table 3.1 Control Unit connector ports and controls (See Figure 3.2)
ITEM
DESCRIPTION
1Handpiece Connector
Receptacle Socket for plugging in handpiece cable
2USB Ports (two) For optional USB remov able storage dev ice
3Emergency Stop Halts system operation if pressed
4On / Off Button
•Momentarily press to turn system ON
•Momentarily press to turn system OFF
•Press and hold to force system shutdown
5Rear Panel USB port For U lthera System Access Key
6Main Power Switch Supplies power to system. Leav e ON (symbol “|
” pressed in)
7Power Cord Receptacle Socket for attachment of power cord

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Below the monitor, on the front panel of the control unit is a handpiece
connector receptacle that interfaces with the handpiece cable. On the
front right of the panel is an On/Off button and an emergency Stop button.
When turned OFF via the On/Off button the system goes into a very low
power standby mode unless the Main Power Switch is also turned to the OFF
position by pressing the ‘O’ symbol. The front of the control unit also has two
Universal Serial Bus (USB) ports: both ports may be used for the Ulthera System
Access Key or for an optional removable storage device (“thumb drive”).
Warning: When not in use by trained personnel, the Ulthera System
Access Key should be removed from the system to help prevent
unauthorized use. Keep the Ulthera System Access Key in a designated
place accessible only to authorized and trained personnel.
The rear of the control unit has a USB port, an AC power receptacle and the
main power switch. The main power switch should be left in the powered
position (with the “|” pressed inward). In such a configuration, the control
unit may be turned ON via the front panel On/Off button and can be turned
OFF via either the front panel On/Off button or the graphical user interface.
3.2.2. Handpiece
The handpiece is a handle with an integrated receptacle for insertion of a
transducer on one end and an electrical cable for attachment to the control
system on the other end. The handpiece has two types of buttons: one to
image (SEE) and the other to deliver therapy (TREAT). Figure 3.3 provides two
views of the handpiece, including one showing it connected to an
Image/Treat transducer. Table 3.2 is a description of the various components
and features illustrated in Figure 3.3.

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Figure 3.3 Handpiece with transducer inserted, top and side v iews.
Table 3.2 Handpiece and Transducer Description
ITEM
DESCRIPTION
1SEE Pushbutton
•Engages IMAGING state (if not already imaging)
•Places system in READY state (times out in 40 seconds)
•Stops TREATING if treatment in progress
2TREAT Pushbuttons Engages TREATING state
3Latch Locks transducer into handpiece
4Transducer Image/treat transducer
5Strain Relief / Cable Connects handpiece to Control Unit
3.2.3. Transducers
Figure 3.4 is an illustration of an image/treat transducer. The transducer can image and treat a
region of tissue up to 25 mm long and can image a depth of up to 8 millimeters. Treatment
occurs along a line less than or equal to the transducer’s active length, which is indicated by
guides on the sides of the transducer, as described in
Table 3.3. An additional guide at the front tip of the transducer represents the
center of the treatment line. In therapy mode, bursts of sound energy create
a linear sequence of individual, discrete, thermal coagulation points (TCPs).
A label atop the transducer provides the transducer type, expiration date,
and other information.
Figure 3.4 Image/Treat Transducer, separated from handpiece (see

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Table 3.3 Transducer Description
ITEM
DESCRIPTION
1Labeling Transducer type and other information
2Treat guides Markers denoting maximum treatment line length
and center of treatment line (center of transducer)
The types of transducers reflect variations in frequencies and treatment
depths as shown in Table 3.4.
Table 3.3 Transducer Types
TRANSDUCER TYPE
TREAT FREQUENCY
TREAT DEPTH
IMAGE DEPTH
SCAN LENGTH
DS 7 – 3.0 7 MHz 3.0 mm 0 − 8 mm 25 mm
DS 7 – 3.0N 7 MHz 3.0 mm 0 – 8 mm 14 mm
DS 4 – 4.5 4 MHz 4.5 mm 0 − 8 mm 25 mm
DS 7 – 4.5 7 MHz 4.5 mm 0 − 8 mm 25 mm
DS 10 – 1.5 10 MHz 1.5 mm 0 − 8 mm 25 mm
DS 10 – 1.5N 10 MHz 1.5 mm 0 − 8 mm 14 mm
3.2.4. Essential Accessories
Other essential components provided for operation of the Ulthera System are
the power cord that connects the Ulthera System to an AC power outlet, and
the proprietary Ulthera System Access Key.
Ultrasound gel to facilitate transmission of the acoustic energy is also required
but is not provided as part of the system.

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3.3. System Specifications
3.3.1. Physical Dimensions
Control Unit
Height 15.3” (389 mm)
Width 16.5” (419 mm)
Depth 13.0” (330 mm)
W eight 22 lbs. (10 kg)
Handpiece and cable, with Transducer
Height 3.9” (99 mm)
Width 2.1” (53 mm)
Depth 11.1” (282 mm)
W eight 1.5 lbs. (.7 kg)
Cable Length 75” (1.9 m)
System (Control Unit, Handpiece with Cable – not including Transducer)
W eight 23.5 lbs. (10.7 kg)
3.3.2. Monitor
15” TFT LCD, 1024 x 768 resolution, with integrated touchscreen.
3.3.3. I/O Connections
USB 2.0, two on the front panel, one rear panel
3.3.4. Transducers
DS 7–3.0 7 MHz Treatment frequency, 3.0 mm depth, (UT-1)
DS7-3.0N 7 MHz Treatment frequency, 3.0 mm depth, narrow patient
contact footprint, (UT-1N)
DS 4–4.5 4 MHz Treatment frequency, 4.5 mm depth, (UT-2)
DS 7–4.5 7 MHz Treatment frequency, 4.5 mm depth, (UT-3)
DS 10-1.5 10 MHz Treatment frequency, 1.5 mm depth, (UT-4)
DS 10-1.5N 10 MHz Treatment frequency, 1.5mm depth, narrow patient
contact footprint, (UT-4N)

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3.3.5. Handpiece
Ulthera DeepSEE Handpiece (UH-2)
3.3.6. Included Accessories
Ulthera System User Access Key (UK-1)
3.3.7. Treatment Controls
Energy, Spacing, Length
See, Treat, Stop, and Cancel
3.3.8. Treatment Parameters
Treat depths: Probe dependent, 1.5 mm to 4.5 mm
Treat Frequency: 4 MHz, 7 MHz,10 MHz nominal
Treat Energy: Less than 3 J
Treat Power: 75 W maximum at 4 MHz (Energy < 3J)
65 W maximum at 7 MHz (Energy < 3J)
15 W maximum at 10 MHz (Energy < 1.5J)
Treat Time On: 0 to 150 ms, 1 ms resolution, (Energy < 3J)
TCP Spacing: 1 to 5 mm, 1.5 mm standard, 0.1 mm resolution
Treat Line Length: 5 to 25 mm
Treatment output energy accuracy: + 20%
3.3.9. Image Display
Modes: B-Mode
Ultrasound frequency range: 12-25 MHz
System Dynamic Range: 110 dB total
Instantaneous Displayed DynamicRange: 53 dB
Scan Lines: 256, at 0.1 mm spacing
Displayed Field of View: 25.6 x 8 mm
3.3.10. Measurement Tools
Distance calipers, 0.1 mm precision, and measurement accuracy ± 5%.

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3.3.11. Power
100 – 240 VAC, 50/60 Hz, 3 A maximum
Fuse: (2) 5 x 20 mm, 6.3 A fast acting, 250 V
3.3.12. Env ironmental
Operating Environment, System, Handpiece and Transducers
Dry location, indoor use only.
10 to 30°C (50 to 86°F), 30 to 95% R.H.
700 to 1060hPa (0.7 to 1.05 ATM)
Shipping and Storage, System without Transducers
-20 to 65°C (-4 to 149°F), 15 to 95% R.H.
500 to 1060hPa (0.5 to 1.05 ATM)
Shipping and Storage, Transducers
15 to 30˚C (59 to 86˚F) Room Temperature, 15 to 95% R.H.
Protect from freezing
500 to 1060hPa (0.5 to 1.05 ATM)