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Merz Ulthera Prime Manual

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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 PERSONAL INJURY AND/OR DAMAGE TO THE SYSTEM THAT MAY
INVALIDATE THE WARRANTY AGREEMENT.
1
Ulthera, Inc.
Page

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Summary of Contents for Merz Ulthera Prime

  • Page 1 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”).
  • Page 2 © 2024, Ulthera, Inc. All Rights Reserved. MERZ AESTHETICS is a trademark and/or registered trademark of Merz Pharma GmbH & Co. KGaA in the U.S. and/or certain other countries. ULTHERA, ULTHERAPY, ULTHERAPY PRIME, DEEPSEE, and the SQUIGGLE logo are trademarks and/or registered trademarks of Ulthera, Inc.

  • Page 3: Table Of Contents

    Table of Contents Introduction to Manual ..................5 1.1. Purpose ......................5 1.2. Conventions ...................... 5 Medical Safety ....................6 2.1. Indications for Use .................... 6 2.2. Contraindications ..................... 6 2.3. Precautions ....................... 7 2.4. Patient Safety ....................8 2.5. Potential Side Effects ..................
  • Page 4 System Operation ..................... 47 7.1. Ulthera System Access Key ................47 ® 7.2. User Interface ....................47 7.3. Operating Instructions ..................54 7.4. Adjunctive Functions ..................60 7.5. Troubleshooting ....................65 System Messages ..................... 67 Cleaning and Care ..................71 9.1. Cleaning the Transducer and Handpiece ............71 9.2.

  • Page 5: Introduction To Manual

    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. Warning: Do NOT operate the Ulthera System before reading this ®...

  • Page 6: Medical Safety

    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; which can also • affect the appearance of lax tissue in the submental and neck regions Improve lines and wrinkles of the décolleté...

  • Page 7: Precautions

    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.

  • Page 8: Patient Safety

    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, such as on or over the eyelids or within the orbital rim. Warning: Use this system only if you are trained and qualified to do so. Warning: 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...
  • Page 9 o Transient numbness may result after treatment due to inflammation of a sensory nerve. This typically resolves in 2 to 6 weeks of treatment. o Transient 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.

  • Page 10: Complaints And Adverse Events

    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 sections 7.3.4 & 7.3.5). Some scars may respond to medical treatment and resolve fully.

  • Page 11: Post- Market Safety Surveillance

    2.7. Post- Market Safety Surveillance The following adverse events have been identified during routine clinical use following FDA clearance (post market) of the Ulthera system, specifically, ® and generally in the clinical literature for devices using micro-focused ultrasound. 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.

  • Page 12: System Overview

    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.
  • Page 13 3.2.1. Control Unit The control unit (UC-1 Control Unit (PRIME)) 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.
  • Page 14 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’...
  • Page 15 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).
  • Page 16 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 mm. 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.

  • Page 17: System Specifications

    Table 3.4 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 –...
  • Page 18 3.3.2. Monitor 18.5” (469.9 mm) TFT LCD, 1920 x1080 resolution, with integrated touchscreen. 3.3.3. I/O Connections USB 2.0, two on the front 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)

  • Page 19: Image Display

    3.3.9. Image Display Modes: B-Mode Ultrasound frequency range: 12-25 MHz System Dynamic Range: 110 dB total Instantaneous Displayed Dynamic Range: 53 dB Scan Lines: 250, at 0.1 mm spacing Displayed Field of View: 25 x 8 mm 3.3.10. Measurement Tools Distance calipers, 0.1 mm precision, and measurement accuracy ±...

  • Page 20: System Safety

    4. System Safety The following precautions and warnings must be reviewed and observed: 4.1. Electrical and Fire Safety Warning: To avoid risk of electric shock, always inspect the Ulthera ® transducer, handpiece and cable before use. Do not use a damaged cable or a transducer that has been damaged or is leaking fluid.

  • Page 21: Equipment Use And Care

    No modification of this equipment is allowed. The Ulthera System should not be used near flammable gases or anesthetics. ® Fire or explosion can result. The Ulthera System is not AP or APG rated. ® Avoid restricting ventilation under and behind the Ulthera control unit.

  • Page 22: Ergonomic Safety

    4.3. Ergonomic Safety Warning: Ultrasound scanning has been associated with repetitive motion injuries such as carpal tunnel syndrome. To reduce chances of such injury, maintain a balanced, comfortable posture while scanning, avoid gripping the handpiece too tightly, and keep hands and arms in a comfortable position while using.
  • Page 23 4.4.1. The ALARA Principle and Usage ALARA (As Low As Reasonably Achievable) is the recommended guidance for ultrasound scanning. Details are thoroughly described in “Medical Ultrasound Safety”, published by the American Institute of Ultrasound in Medicine (AIUM). The Ulthera System has a fixed, low acoustic output for ®...
  • Page 24 4.4.2. Acoustic Output Measurement The acoustic output for the Ulthera was measured and calculated in ® accordance with IEC 60601-2-37 (imaging) and IEC 60601-2-62 (therapy). Table 4.1 Acoustic Output Parameter Description PARAMETER DESCRIPTION Mechanical Index Soft Tissue Thermal Index in an auto-scanning mode. Derated pulse average intensity at MI maximum pa,α...
  • Page 25 Measurement uncertainty for power, pressure, intensity, and other quantities that are used to derive the values in the acoustic output table were derived in accordance with IEC 60601-2-37 and were below limits which would affect global output levels. The measurement uncertainty values were determined by making repeat measurements.
  • Page 26 Figure 4.1 1-D Z Scan Plots (Data gathered from 1005101RPT) Cavitation is not expected due to insufficient total entry power. The peak negative pressure does not generate cavitation or sufficient heating to produce a tissue effect outside of the designated treatment area. Page Ulthera, Inc.
  • Page 27 Table 4.5 Ultrasound Entry Power 4 MHz Total Entry Power (W) at Clinical Settings (mm) Ipta Entry Effective Intensity at Clinical Settings (I ) x10 Peak Rarefactional Acoustic Pressure at Clinical Settings (Pa x 10 27.5 7 MHz Total Entry Power (W) at Clinical Settings (mm) Ipta Entry Effective Intensity at Clinical Settings (I...

  • Page 28: Electromagnetic Compatibility And Immunity

    4.5. Electromagnetic Compatibility and Immunity The Ulthera System’s RF emissions are very low and are not likely to cause ® interference in nearby electronic equipment. The Ulthera System is suitable for use in all establishments other than domestic ® and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.

  • Page 29: Guidance And Manufacturer's Declaration - Electromagnetic Emissions

    4.5.1. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Ulthera System is intended for use in the electromagnetic environment ® specified below. The user should assure that it is used in such an environment. Table 4.6 Electromagnetic Emissions ELECTROMAGNETIC ENVIRONMENT - EMISSIONS TEST COMPLIANCE GUIDANCE...

  • Page 30: Guidance And Manufacturer's Declaration - Electromagnetic Immunity

    4.5.2. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Table 4.7 Electromagnetic Immunity IMMUNITY TEST IEC 60601 TEST COMPLIANCE LEVEL ELECTROMAGNETIC LEVEL ENVIRONMENT - GUIDANCE Electrostatic ±8 kV contact ±8 kV contact Floors should be wood, discharge concrete or ceramic ±2, 4, 8,15 kV air ±2, 4, 8, 15kV air (ESD) tile.
  • Page 31 Table 4.8 Electromagnetic Immunity Continued IMMUNITY TEST IEC 60601 COMPLIANCE ELECTROMAGNETIC TEST LEVEL LEVEL ENVIRONMENT - GUIDANCE Portable and mobile RF communications equipment should be used no closer to any part of the Ulthera System, ® including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
  • Page 32 Table 4.9 IEC 60601-1-2 Test Specifications for Enclosure Port Immunity to RF Wireless Communication Equipment Test Frequency Band Service Modulation Immunity Test (MHz) (MHz) Level (V/m) 380 to TETRA 400 Pulse Modulation 18 Hz 430 to GMRS 460, FRS 460 ±...

  • Page 33: Disposal

    4.5.3. Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Ulthera System ® Ulthera is intended for use in an electromagnetic environment in which ® radiated RF disturbances are controlled. The Ulthera System user can help ® prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Ulthera...

  • Page 34: Safety Symbols

    4.7. Safety Symbols A variety of symbols appear on the transducer, handpiece, or control unit in accordance with regulatory guidance. SYMBOL DEFINITION Type B Applied Part (Reference Number 5840)** CE marking indicating manufacturer’s declaration of compliance with appropriate EU product directives TÜV SÜD Certification Mark Consult instructions for use (Reference Number 5.4.3)* Date of Manufacture (Reference Number 5.1.3)*...
  • Page 35 Catalogue Number (Reference Number 5.1.6)* Manufacturer (Reference Number 5.1.1)* Authorized representative in the European Community (Reference EU Blue Book Guide) Storage Temperature Limit (Reference Number 5.3.7)* Keep Dry (Reference Number 5.3.4)* Fragile, handle with care (Reference Number 5.3.1)* Relative Humidity Limitation (Reference Number 5.3.8)* Use-by date (Reference Number 5.1.4)* Batch code (Reference Number 5.1.5)* Alternating Current (Reference Number 5032)**...

  • Page 36: Setting Up For First-Time Use

    5. Setting Up for First-Time Use 5.1. Unpacking The control unit and handpiece are shipped together in one container. Transducers are packaged and shipped separately from the control unit and handpiece, in ready-to-use, non-sterile pouches. 5.2. Physical Environment 5.2.1. System Base The system may be placed on a cart or counter with the depth to accommodate the control unit, handpiece and power cord/pigtail provided.

  • Page 37: Electrical Requirements

    5.2.2. Electromagnetic Environment (see the detailed EMC Guidance in Section 4.5) The system is not likely to cause interference in nearby electronic equipment; however, other electronic equipment should not be stacked or placed immediately adjacent to the system. Flooring should be wood, concrete or ceramic tile. If covered with synthetic material, the relative humidity should be at least 30%.

  • Page 38: Connecting Components

    5.4. Connecting Components 5.4.1. Connecting the Handpiece The handpiece connector receptacle is located on the left side of the control unit’s front panel as shown in Figure 5.1. To attach the handpiece connector, align it with the white dot facing up and push it into the receptacle.
  • Page 39 5.4.2. Identifying and Connecting Transducers Transducers are identified by the label on the top of the transducer which includes the name of the transducer (Ulthera DeepSEE ), treatment ® ® frequency and treatment depth (DS X-X), a unique serial number, a part number, and date of manufacture.

  • Page 40: Treatment Guidelines

    6. Treatment Guidelines 6.1. Preset Guidelines and Energy Levels The Ulthera System is programmed with preset guidelines that have been ® established through clinical experience. Table 6.1 describes the preset guidelines available on your system. Table 6.1 Guideline Names and Energy Levels Energy Level Default Guideline Name...
  • Page 41 Table 6.2 Transducer Energy Levels ENERGY LEVELS [J] TRANSDUCER LEVEL 4 LEVEL 3 LEVEL 2 LEVEL 1 LEVEL 0 DS 4 - 4.5 1.20 1.00 0.90 0.75 0.00 DS 7-4.5 1.05 0.90 0.75 0.66 0.00 DS 7 - 3.0 0.45 0.35 0.30 0.25...
  • Page 42 6.1.1. Face & Neck (Amplify) Page Ulthera, Inc...
  • Page 43 6.1.2. General Regions (Face & Neck) Ulthera, Inc. Page...
  • Page 44 6.1.3. Décolleté 6.1.3.1. Clinical Trial Results To support the expanded indication, the Ulthera System was evaluated in a ® prospective safety and efficacy study investigating the clinical response following treatment with the Ulthera System to achieve improvement of lines ® and wrinkles of the décolleté.
  • Page 45 Table 6.4 Masked Assessment Results of Evaluable Subject Photos Improvement 36 (~67%) Incorrect 13 (24%) No Change 5(9%) In the sub-set of evaluable photos, there were 36 of 54 (~67%) subjects that showed improvement by masked assessment of pre and post treatment photographs at the primary endpoint of 180 days.
  • Page 46 The following transducers are not included in this treatment protocol: UT-4N: Ulthera DeepSEE Narrow Transducer DS 10-1.5N ® ® UT-1N: Ulthera DeepSEE Narrow Transducer DS 7-3.0N ® ® UT-3: Ulthera DeepSEE Transducer DS 7-4.5 ® ® Page Ulthera, Inc...

  • Page 47: System Operation

    7. System Operation 7.1. Ulthera System Access Key ® A secure USB Access Key is provided to give the user access to Ultherapy PRIME ® treatment on the system. Ultherapy PRIME treatment cannot be delivered until ® the Access Key is inserted into one of the USB ports on the control unit. It is the responsibility of the user to: 1.
  • Page 48 7.2.1. The DeepSEE Screen ® Figure 7.2 shows an example of the user interface when the DeepSEE tab is ® active. Each element is described in Table 7.1. Figure 7.2 DeepSEE Screen ® Imaging Controls ① Home Bar ② Treatment Controls ③...
  • Page 49 Table 7.1 Elements on DeepSEE Screen ® ITEM FUNCTION Shows an ultrasound image of the tissues being imaged. The horizontal green line Ultrasound Image indicates the depth at which treatment will be delivered. The circular icon to the right of the depth indicator starts or stops scanning Scan Button (imaging).
  • Page 50 7.2.2. Tools Menu The Tools icon in the upper right corner of the screen displays the Tools menu shown in Figure 7.3 and described in Table 7.2. Figure 7.3 Tools Menu Table 7.2 Tools ITEM FUNCTION Volume Buttons Decreases or increases the volume of the system. The button with hash marks displays or removes the Treat Line green treat line displayed on the ultrasound image.
  • Page 51 7.2.3. User Regions The Ulthera System allows you to create and edit treatment guidelines to ® more accurately reflect and record how treatments are performed. Treatment energies are not editable beyond the safety limits that have been previously determined. Under Treatment Settings select Edit User Regions from the drop-down menu, as shown in Figure 7.4.
  • Page 52 Figure 7.5 and Table 7.4 display the process and functionality of creating a User Region: Figure 7.5 User Regions, Planning Screen Page Ulthera, Inc...
  • Page 53 Table 7.4 User Regions Treatment Guideline Dialogue ITEM DESCRIPTION User Region Guideline The name of the treatment guideline is entered in this field. Name Field Clinician Field The name of the clinician treating is entered here. Region Name Field for entering or editing the name of the region. Field for selecting the transducer for the region that is Transducer highlighted.

  • Page 54: Operating Instructions

    7.3. Operating Instructions 7.3.1. Activate the control unit: Connect the power cord pigtail to the rear of the control unit. Connect the supplied AC power cord with line filter and plug to the power cord pigtail, then plug other end into a wall outlet. Turn the main power switch to the ON position.
  • Page 55 7.3.2. Set up a treatment record: 1. The Patient Info screen shown in Figure 7.6 is the Patient Info Screen displayed when you turn on the system. Figure 7.6 Patient Info Screen 2. Use the touchpad keyboard to enter the patient name, patient ID and the name of the clinician who will perform the treatment.

  • Page 56: Specifications

    7.3.3. Select a transducer: The Ulthera System has six types of transducers: ® Table 7.5 Types of Transducers TRANSDUCER SPECIFICATIONS DS 10 – 1.5 Low energy level and 1.5 mm focal depth. Low energy level, 1.5 mm focal depth, and a narrower contact area DS 10 –...
  • Page 57 7.3.4. Scan the region to be treated: Tap the region to be treated from the available regions and it will highlight white showing you the number of lines that have been delivered in the center of the region. The energy and treatment line length will be set to appropriate levels for the entire treatment session unless manually adjusted by the user.
  • Page 58 Warning: Improper coupling could cause adverse events such as those listed in Section 2.5. Figure 7.9 shows the difference between images when coupling is good versus poor. Good coupling produces Poor coupling produces dark vertical an image with no dark areas. bars on the tissue image.
  • Page 59 7.3.5. Deliver treatment lines: Press the See button on the handpiece when you have confirmed adequate coupling and transducer positioning to enter the Ready state. When the system enters or exits the Ready state, a tone will sound and buttons on the handpiece will be lit. The Ready state is terminated after 40 seconds if the Treat button is not pressed but can be reactivated by pressing the See button again.

  • Page 60: Adjunctive Functions

    To start treatment in another region, tap the desired region. The previously treated region will change to the color of the transducer that was used, and the selected region will become Active (white). Previous treatment regions treated with a transducer other than the one currently inserted may be reviewed by tapping the appropriate transducer button on the left-hand side of the screen.
  • Page 61 7.4.2. Annotations When the Ulthera System is not actively imaging, you may add comments ® on the ultrasound image. To make a note on ultrasound images: Tap the Tools icon on the DeepSEE screen. ® Tap the Text icon on the Tools menu. A text box will appear near the center of the image and a keyboard will appear below the image.
  • Page 62 7.4.3. Database Records The Ulthera System has a proprietary database for storing a limited number ® of images and treatment record information. Images are saved when the user taps the Save button on the DeepSEE screen. Treatment records are ® automatically saved after ending a treatment session.
  • Page 63 Figure 7.11 Patient Image Record List Tap an individual Patient ID to access that individual image or tap the Select All button to access all stored images. Note: You may select multiple images by tapping on them individually. Tapping a selected image again will deselect it. You may also tap Deselect All to deselect all images.
  • Page 64 To delete this data from your device prior to sending it in for service, follow the steps identified below: Deleting data: Save the records to be deleted from the database on an accessory device. (This step is not required, but it is highly recommended) Tap the Delete button to remove an individual item or tap the Select All button and then the Delete button to remove all items from the database.

  • Page 65: Troubleshooting

    7.5. Troubleshooting 7.5.1. Warning Screens System warnings provide information and instructions for resolving issues that may occur. Follow the instructions provided, but please make note of any code letters presented in case Technical Support is needed. Figure 7.12 shows a sample warning screen. Figure 7.12 Warning Screen Warning: These dialogs indicate that a problem was detected.
  • Page 66 7.5.3. Shutting Down the System Stop any imaging and/or treatment in progress prior to shutting down the system. From the Setup screen, tap the Shutdown button. Remove the Ulthera System Access Key to prevent unauthorized usage. ® 4. Leave the main power switch located on the rear panel of the control unit in the ON position;...

  • Page 67: System Messages

    8. System Messages The Ulthera System is designed with internal checks to ensure that all aspects ® of the device are functioning appropriately. In the event that an information message presents itself during use, please follow the instructions on the screen or refer to the information listed below.
  • Page 68 Code H Transducer motion not detected Transducer motion was not detected. Ensure that the transducer is properly Please remove and reinsert the mounted in the handpiece. Please be transducer. sure to always hit Scan N before If the problem persists please removing transducer.
  • Page 69 Code N A problem was detected with the USB flash memory connectivity attached USB flash memory drive. Make sure the drive is properly Please check flash drive and formatted and has enough free space. continue. Do not remove the drive while the See User’s Manual for further system is communicating with it.
  • Page 70 Code W Unauthorized transducer. The transducer connected is not an Please replace the transducer authorized transducer. Contact your and continue. local representative for further assistance. Please contact your local representative for further assistance. Code X Transducer cannot be read The transducer cannot be read. Please remove and reinsert the Remove and reinsert the transducer.

  • Page 71: Cleaning And Care

    9. Cleaning and Care 9.1. Cleaning the Transducer and Handpiece Note: Transducers are packaged and shipped non-sterile and ready to use. Because the transducer will come in contact with the skin of a patient, the standard practice for cleaning and low-level disinfection of transducers between patients is to gently but thoroughly wipe the transducers with a standard 70% isopropyl alcohol prep pad for a minimum of one minute.
  • Page 72 Do not twist or pull the handpiece cables. This could cause damage to internal wires and connections. Use aqueous ultrasound gel only. Other lubricants or lotions, particularly mineral oil, could eventually damage transducers or cables. Do not use acoustic standoff pads or any objects between the transducer and patient.

  • Page 73: Re-Order Information

    10. Re-order Information Please contact Ulthera, Inc. or your country representative to order transducers or other items for your system. CATALOG/ DESCRIPTION REORDER NUMBER Ulthera Control Unit (PRIME) UC-1 ® Ulthera DeepSEE Handpiece UH-2 ® ® Ulthera DeepSEE Transducer DS 7-3.0 UT-1 ®...

  • Page 74: Safety Standards And Regulatory Classifications

    11. Safety Standards and Regulatory Classifications FDA Product Classification 21 CFR § 878.4590. Class II Medical Device in the US Type B applied part, non-AP/APG rated. CISPR 11 Group 1 Class A Ingress protection: IPx0 (“Ordinary Equipment”) for Control Unit; IPx1 for mated transducer and handpiece.
  • Page 75 IEC 60601-2-37:2007/AMD1:2015 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment IEC 60601-2-62:2013 Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment IEC 62304: 2006/A1: 2015 Medical Device Software – software life cycle processes ANSI/AAMI/IEC 62366-1:2015 (R2021)+AMD1:2020 Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices + Amendment 1 CAN/CSA-IEC 62366-1:15 (R2020) + A1:21 (CONSOLIDATED) Medical devices - Part 1: Application...
  • Page 76 Ulthera, Inc. 6501 Six Forks Rd Raleigh, NC 27615 Phone +1 919-582-8000 & 1-877-858-4372 Ultherapy.com 1015390IFU Rev 01 Page Ulthera, Inc...

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