Summary of Contents for Ulthera DeepSEE DS 4 - 4.5
- Page 1 Ulthera System ® Instructions for Use Featuring DeepSEE Technology for Ultherapy ® ® Ulthera, Inc. Page...
- Page 2 THIS PAGE INTENTIONALLY LEFT BLANK Page Ulthera, Inc.
- Page 3 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 4 ® ® 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.
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Page 5: Table Of Contents
Setting Up for First-Time Use ................. 32 5.1. Unpacking..................... 32 5.2. Physical Environment ..................32 5.3. Electrical Requirements ................33 5.4. Connecting Components ................33 Treatment Guidelines ................... 35 6.1. Preset Guidelines and Energy Levels ............35 System Operation....................43 Ulthera, Inc. Page... - Page 6 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 System Messages....................61 Cleaning and Care....................65 9.1. Cleaning the Transducer and Handpiece ..........65 9.2.
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Page 7: Introduction To Manual
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. -
Page 8: Medical Safety
2.3. Precautions W hen 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 9: Patient Safety
Bell’s Palsy 2.4. Patient Safety W arning: Ulthera should not be used on a patient’s eyes or in a location or technique where ultrasound energy can reach the eye. W arning: Use this system only if you are trained and qualified to do so. -
Page 10: Potential Side Effects
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 •... -
Page 11: Complaints And Adverse Events
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. -
Page 12: Post- Market Surveillance
Ulthera system. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal... -
Page 13: System Overview
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. Ulthera, Inc. - Page 14 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.
- Page 15 ‘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”).
- Page 16 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 Page Ulthera, Inc.
- Page 17 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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Page 18: System Specifications
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) Page Ulthera, Inc. - Page 19 3.3.5. Handpiece Ulthera DeepSEE Handpiece (UH-2) 3.3.6. I ncluded 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 <...
- Page 20 -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) Page Ulthera, Inc.
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Page 21: System Safety
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: Equipment Use And Care
Contact Ulthera, Inc. if service is required. W hen 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 23 Details are thoroughly described in “Medical Ultrasound Safety”, published by the American Institute of Ultrasound in Medicine (AIUM), 1994 [1]. The Ulthera system has a fixed, low acoustic output for imaging which helps keep exposure and bio-effects to a minimum. This simplicity of the Ulthera system and clinical protocols enhances the user’s...
- Page 24 4.4.2. Acoustic Output Measurement The acoustic output for the Ulthera was measured and calculated in accordance with the “Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment” (AIUM, NEMA, 2004) and the “Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment”...
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Page 25: Electromagnetic Compatibility And Immunity
Diagnostic Ultrasound Systems and Transducers, FDA, 2008. 4.5. Electromagnetic Compatibility and I mmunity The Ulthera System’s RF emissions are very low and are not likely to cause interference in nearby electronic equipment. Ulthera 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 26 30% to avoid excessive static electricity. W arning: The Ulthera System should not be situated adjacent to, or stacked with, other electronic equipment. If the system must be installed in close proximity to other equipment, both the Ulthera System and the nearby equipment should be observed to verify normal operation in that configuration.
- Page 27 W arning: The Ulthera system should not be used adjacent to, or stacked with other electronic equipment. If the system must be installed in close proximity to other equipment, both Ulthera and the nearby equipment should be observed to verify normal operation in that configuration.
- Page 28 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.
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Page 29: Disposal
4.5.3. Recommended Separation Distances betw een 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 user can help prevent electromagnetic interference by maintaining a minimum distance between... -
Page 30: Safety Symbols
Consult instructions for use Date of Manufacture Serial Number Emergency Stop Power Standby Switch Indoor Use Only Keep electrical waste separate from municipal waste Recycle Packaging Mated handpiece and transducer protected from the IPx1 effects of v ertically dripping water Page Ulthera, Inc. - Page 31 Authorized representativ e in the European Community Storage Temperature Limit Keep Dry Fragile, handle with care Relativ e Humidity Limitation Use-by date Batch code Atmospheric Pressure Limitations Recycle Packaging (Polyethylene) Mandatory Action Sign Refer to Instruction Manual/Booklet Ulthera, Inc. Page...
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Page 32: Setting Up For First-Time Use
Flooring should be wood, concrete or ceramic tile. If covered with synthetic material, the relative humidity should be at least 30%. W arning: The Ulthera System should not be situated adjacent to, or stacked with, other electronic equipment. If the system must be installed... -
Page 33: Electrical Requirements
5.3. Electrical Requirements The Ulthera System has an international power supply and may be used with 100-240 VAC, 50-60 Hz power systems. See Section 4.1 Electrical and Fire Safety for additional information. 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. - Page 34 W hen the transducer is inserted, the control unit automatically detects it and updates the graphical user interface. 5.4.3. Connecting Accessories The Ulthera System Access Key should be inserted into one of the available USB ports; otherwise, the message “No Key” will appear and the software will not allow user access.
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Page 35: Treatment Guidelines
6. Treatment Guidelines 6.1. Preset Guidelines and Energy Lev els 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 Lev els... - Page 36 Note: Ending the treatment session and starting a new session with the same or different guideline will put all transducers back to the default energy settings as prescribed by the guideline. Page Ulthera, Inc...
- Page 37 The recommended line count for each region is depicted by the numerical value displayed. Regions shown without a numerical value are regions that are available for the treating clinician to select and treat at their discretion, but a specific line count is not directed. Ulthera, Inc. Page...
- Page 38 6.1.1. Face & Neck (Amplify) Page Ulthera, Inc...
- Page 39 6.1.2. General Regions (Face & Neck) Ulthera, Inc. Page...
- Page 40 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. The clinical study’s protocol was approved under IDE G120004 for enrolling up to 130 female subjects between the ages of 35-60 at up to 4 sites with a 90 and 180 day follow up.
- Page 41 Please note that treatment efficacy was achieved at the pre-set energy levels of Level 4 for the 7 - 3.0 and 4 - 4.5 transducers and energy Level 3 for the 10 – 1.5 transducer. Changes in energy may impact efficacy. Ulthera, Inc. Page...
- Page 42 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...
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Page 43: System Operation
System. 7.2. User I nterface The main screen on the Ulthera System monitor has three tabs located in the upper right corner of the screen: DeepSEE, Patient Info, and Setup. The DeepSEE tab displays the controls for imaging and treating soft tissue. The Patient Info tab displays information and tools for beginning a treatment and setting up a patient record. - Page 44 Number of lines that have been delivered during this treatment session. The number of lines deliv ered. This line count value may be reset by tapping the Current Line Count Reset button immediately below the line count value. Page Ulthera, Inc...
- Page 45 A Disabled region is transparent with a light gray border. Disabled regions cannot be selected. User Regions Displays a list of regions as defined by the user. Tap End Treatment followed by Confirm End to end the treatment session. End Treatment Ulthera, Inc. Page...
- Page 46 The Sav e button sav es the currently displayed image. Allows you to set markers for measuring distances Measurement within a scanned image. Marker Buttons The Text button displays a keyboard for recording Text notes on an image. Page Ulthera, Inc...
- Page 47 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 48 Field for selecting the default energy that will be used for the region that is highlighted. Default Energy When a transducer’s energy lev el is changed in an existing User Region Guideline, all energy lev els will be updated in that guideline for that transducer type. Page Ulthera, Inc...
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Page 49: Operating Instructions
Note: Do NOT use the power switch to shut down the system. Insert the Ulthera System Access Key into the USB port on the back of the control unit. The Ulthera System operates only with the authorized Access Key. - Page 50 Tap the Start Treatment button located in the upper right corner of the screen. Note: W hen the Start Treatment button has been pressed, the patient name, patient ID, and treatment guideline may not be changed until the current treatment is ended. Page Ulthera, Inc...
- Page 51 Caution: If a warning or caution message is displayed, or a message that says “Transducer Not Connected,” disconnect and reconnect the transducer. If the problem persists, contact your Ulthera representative. Caution: If the handpiece or transducer is dropped or broken, or any part of the system is damaged, disconnect the system from the power source outlet before touching any other part of the equipment.
- Page 52 For example, with length set to 25 mm, and a spacing of 1.5 mm (center to center), a treatment line would have 17 TCPs. Page Ulthera, Inc...
- Page 53 W hen 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. Ulthera, Inc. Page...
- Page 54 W hen all regions have been treated, tap the End Treatment button in the lower right corner of the DeepSEE screen and then tap Confirm End. Page Ulthera, Inc...
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Page 55: Adjunctive Functions
Scan button on the DeepSEE screen, the distance markers will disappear from the image. 7.4.2. Annotations W hen 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. - Page 56 To save this image with annotations, press the Tools icon and then press Save. 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 57 If you want the data to remain on the system after exporting to the Access Key, tap the Close button to return to the Setup screen. Exporting treatment records may be done by following these same steps for Records. Ulthera, Inc. Page...
- Page 58 NOTE: For quality and safety reasons, the Ulthera® System collects data regarding patient treatment and stores it on the device. If a device operator enters a patient name or static patient identifier into the user interface screen on the device, an identified patient record is created and stored.
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Page 59: Troubleshooting
To improve image quality: Check that the display brightness is set appropriately for the connected transducer. Check the gel on the transducer. If these steps do not resolve the problem, contact Ulthera, Inc. or your country representative for assistance. Ulthera, Inc. Page... - Page 60 From the Setup screen, tap the Shutdown button. Remove the Ulthera System Access Key to prevent unauthorized usage. Leave the main power switch located on the rear panel of the control unit in the ON position; turn it off only when moving the system.
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Page 61: 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 62 Scan N before If the problem persists please remov ing transducer. Remov e and see the User’s Manual for further reinsert the transducer. information or contact Ulthera Support. Code I Communication halted Please restart the system.
- Page 63 Code Ms. Code M’s and has been locked from further use. This is to allow for further Please contact Ulthera Support assessment by Ulthera in order to minimize risk. Code P Hardware halted Please restart the system.
- Page 64 If the problem persists, please try another transducer and Tap Scan Y to resume scanning contact Ulthera Support. Use If the problem persists please Transducer only as instructed. Tap see the User’s Manual for further Scan Y to resume scanning.
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Page 65: Cleaning And Care
Do not use acoustic standoff pads or any objects between the transducer and patient. Apply ultrasound gel only to the area to be treated and wipe it from the transducer after completing a treatment. Avoid getting the gel on the handpiece or control unit. Ulthera, Inc. Page... - Page 66 Do not hold the handpiece in a manner that can damage the cord or strain relief while removing or inserting transducers. Caution: Always check the expiration date on the transducer before using. Expired transducers should not be used. Page Ulthera, Inc...
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Page 67: Re-Order Information
10. Re-order Information Please contact Ulthera, Inc. or your country representative to order transducers, accessories, or other items for your system. CATALOG/ DESCRIPTION REORDER NUMBER Ulthera Control Unit UC-1 Ulthera ® DeepSEE ® Handpiece UH-2 Ulthera ® DeepSEE ® Transducer DS 7-3.0... -
Page 68: Safety Standards And Regulatory Classifications
IEC60601-1-2, Electromagnetic Compatibility. CISPR 11 class A, Group 1. IEC60601-2-37, Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment Patient contacting materials comply with ISO 10993-1 NRTL Certification: Canadian Standards Association (CSA) ISO 13485 Quality Assurance Standard Page Ulthera, Inc... - Page 69 THIS PAGE INTENTIONALLY LEFT BLANK Ulthera, Inc. Page...
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- Page 72 1840 South Stapley Driv e, Suite 200 Merz Pharmaceuticals GmbH Mesa, Arizona 85204 Eckenheimer Landstraße 100 Phone +1 480 619 4069 & 1-877-858-4372 D-60318 Frankfurt am Main Ultherapy.com Germany + 49 (0) 69 1503 – 0 Page 1004125IFU Rev J |Ulthera, Inc...