Ulthera DeepSEE DS 4 - 4.5 Instructions For Use Manual Download Page 68

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Ulthera, Inc

11.

Safety Standards and Regulatory
Classifications

FDA Product Classification 878.4590

UL60601-1, IEC60601-1 Medical Electrical Equipment, Part 1: General Requirements for

Safety.

Class I dev ice, type B applied part, non AP/APG rated.

Ingress protection: IPx0 (“Ordinary Equipment”) for Control Unit; IPx1 for mated

transducer and handpiece.

Mode of operation: Continuous.

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

Summary of Contents for DeepSEE DS 4 - 4.5

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

Page 2: ...Page 2 Ulthera Inc THIS PAGE INTENTIONALLY LEFTBLANK...

Page 3: ...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 T...

Page 4: ...ernationally 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...

Page 5: ...cription 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 Ul...

Page 6: ...perating 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 1...

Page 7: ...r 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 o...

Page 8: ...oid 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...

Page 9: ...disorder or hemostatic dysfunction o An active systemic or local skin disease that may alter wound healing o Herpes Simplex o Autoimmune Disease o Diabetes o Epilepsy o Bell s Palsy 2 4 Patient Safety...

Page 10: ...weakness may result after treatment due to inflammation of a motor nerve This typically resolves in 2 to 6 weeks of treatment o Transient numbness may result after treatment due to inflammation of a...

Page 11: ...ithin 4 days to 5 weeks of treatment o Tingling may result after treatment and typically resolves within 3 to 5 days of treatment o Itching may result after treatment and typically resolves within 1 t...

Page 12: ...h 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...

Page 13: ...s 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...

Page 14: ...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 Fi...

Page 15: ...lthera 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...

Page 16: ...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...

Page 17: ...EAT 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...

Page 18: ...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...

Page 19: ...imum 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 T...

Page 20: ...e 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...

Page 21: ...d Do not touch the USB connectors and the patient at the same time Turn off the AC power switch and disconnect the AC power supply before cleaning the control unit Do not remove the covers on the cont...

Page 22: ...e 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 4 3 Ergonomic Safety Warning Ult...

Page 23: ...erefore minimizes exposure time The Ulthera imaging therapy transducer selection depends upon the desired clinical protocol The variables which affect the way the user implements the ALARA principle i...

Page 24: ...mit pattern giv ingrise to the v alue reported under MI megapascals PII PII 3 Pulse intensity integral and derated PII Wo Ultrasonic power milliwatts fc Center frequency MHz For MI fc is the center fr...

Page 25: ...Equipment NEMAUD2 2004 3 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment American Institute of Ultrasound in Medicine 2004a 4 Acoust...

Page 26: ...lity is degraded by EMI the system may need to be relocated or reconfigured Warning Use of accessories other than those specified may result in increased emissions or decreased immunity of this system...

Page 27: ...should be that of a typical commercial or hospital env ironment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that o...

Page 28: ...ed by an electromagnetic site surv ey should be less than the compliance lev el in each frequency range Interference may occur in the v icinity of equipment containing a transmitter Radiated RF IEC 61...

Page 29: ...mmunications equipment Table 4 8 Recommended Separation Distances RATED MAXIMUM OUTPUT POWER OF TRANSMITTER IN W SEPARATION DISTANCE ACCORDING TO FREQUENCY OF TRANSMITTER METERS 150 kHz to 80 MHz d 1...

Page 30: ...indicating manufacturer s declaration of compliance with appropriate EU product directiv es Canadian Standards Agency Consult instructions for use Date of Manufacture SN Serial Number Emergency Stop P...

Page 31: ...tativ 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 Po...

Page 32: ...ection 3 of the Technical Information Manual The System is not likely to cause interference in nearby electronic equipment however other electronic equipment should not be stacked or placed immediatel...

Page 33: ...ing up and push it into the receptacle It will latch when seated properly Figure 5 1 Handpiece Connector Receptacle To disconnect the handpiece twist the coupling ring on the connector counterclockwis...

Page 34: ...ducer lift the latch at the tip of the handpiece and slide the transducer straight out of the handpiece Caution Do not apply force displacement to latching cantilever without a transducers installed i...

Page 35: ...To facilitate training with your system specific training guidelines have been pre programmed into the guideline list as well These are noted as Train These training guidelines should be used for tra...

Page 36: ...treatment The user has the ability to adjust these energy settings by using the Energy control described in Section 7 2 1 If adjusted the system shall retain the setting across all regions for that p...

Page 37: ...0 24 mm 0 25 mm DS 10 1 5N 0 34 0 24 mm 0 25 mm Linearly calculated per60601 2 62and w ith attenuation of soft tissue assumption The preset guidelines as they appear on the System for each transducer...

Page 38: ...Page 38 Ulthera Inc 6 1 1 Face Neck Amplify...

Page 39: ...Ulthera Inc Page 39 6 1 2 General Regions Face Neck...

Page 40: ...hoc retrospective masked assessment of pre and post treatment photographs There were no pre specified success criteria of the masked assessment established at the beginning of the clinical trial In ad...

Page 41: ...ovement Improved improved much improved very much improved No Change Worse Satisfied satisfied very satisfied Neither Satisfied nor Dissatisfied Dissatisfied dissatisfied very dissatisfied Yes No Impr...

Page 42: ...Inc 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 Tran...

Page 43: ...r use it is highly recommended that you insert the Access Key into the rear USB port so that it is not bumped or damaged during continual use Figure 7 1 Ulthera System Access Key Warning Do NOT format...

Page 44: ...treatmentwill be delivered Scan Button The circular icon to the right of the depth indicator starts or stops scanning imaging Brightness Controls Large Sun icon Increases ultrasoundimage brightness du...

Page 45: ...selected Facial Graphic The facial graphic indicates the status of treatment regions An av ailable region is displayed semi highlightedandcontains the recommended line count for that region The number...

Page 46: ...Buttons Decreases or increases the v olume of the system 2 Image Buttons Treat Line The button with hash marks displays or remov es the green treat line displayed on the ultrasound image Sav e The Sa...

Page 47: ...der Treatment Settings select Edit User Regions from the drop down menu as shown in Figure 7 4 Figure 7 4 User Regions first screen The User Regions section displays regions as created by the user wit...

Page 48: ...Edit Region Fields Region Name Field for entering or editing the name of the region Transducer Field for selecting the transducer for the region that is highlighted Number of Lines Field for entering...

Page 49: ...be re entered 9 Close Button Closes the User Region Guideline dialogue without sav ingany changes that hav e been made 7 3 Operating Instructions 7 3 1 Activate the control unit 1 Plug the power cord...

Page 50: ...e removed from this list by 1 tapping the name 2 tapping the key 3 tapping the Del key and then 4 tapping the Enter key 4 Select the desired treatment guideline from the list located above the touchpa...

Page 51: ...r to the handpiece by sliding the transducer into the handpiece until the passive latch locks into place Figure 7 7 Connecting the Transducer A tone will sound when thetransducer has been correctly in...

Page 52: ...a to be treated Warning Too much or too little gel will obstruct skin contact could cause adverse events such as those listed in Section 2 6 Do not use other lubricants or lotions because they may dam...

Page 53: ...bdermal layers and surface of the bone Visualization of dermal and subdermal layers and bone showing that a more superficial transducer may be more appropriate Figure 7 10 Image of Dermal Layers and S...

Page 54: ...ment line press the See button on the handpiece to ready the system and then press the Treat button again 4 After approximately every five treatment lines visually check the image to determine if more...

Page 55: ...e starting point The ending point marker will appear with a line between the two points 5 Touch the ending point maker and drag it to the end point for the measurement When you lift your finger from t...

Page 56: ...s the Save button on the DeepSEE screen Treatment records are automatically saved after ending a treatment session The saved images and information can be browsed or exported to another storage device...

Page 57: ...hown in Figure 7 11 Figure 7 11 Patient Image Record List 2 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 mu...

Page 58: ...to remove an individual item or tap the Select All button and then the Delete button to remove all items from the database Note If you delete one or more patients by mistake tap the Undelete button t...

Page 59: ...is needed Figure 7 12 shows a sample warning screen Figure 7 12 Warning Screen Warning These dialogs indicate that a problem was detected See System Messages section for more details 7 5 2 Poor Image...

Page 60: ...ogress prior to shutting down the system 2 From the Setup screen tap the Shutdown button 3 Remove the Ulthera System Access Key to prevent unauthorized usage 4 Leave the main power switch located on t...

Page 61: ...rt The internal handpiece temperature is abov e its limit Allow the handpiece to cool down C Code C Hardware halted Please restart the system If the problem persists please see the User s Manual for f...

Page 62: ...ication halted Please restart the system If the problem persists please see the User s Manual for further information or contact Ulthera Support Communication halted due to an ev ent detected in the c...

Page 63: ...the User s Manual for further information or contact Ulthera Support Hardware was halted due to an ev ent detected in the control unit S Code S The red STOP button has been pressed Please restart the...

Page 64: ...to resume scanning W Code W Unauthorized transducer Please replace the transducer and continue Please contact your local representativ e for further assistance The transducer connected is not an autho...

Page 65: ...not use acetone or other solvents as this can damage the transducer 9 2 General Care of the System To get the best possible performance treat the equipment carefully by adhering to the following guide...

Page 66: ...sealed pouches until ready for use 10 Take care to store transducers in a safe and secure location to prevent damage in between usage 11 Do not hold the handpiece in a manner that can damage the cord...

Page 67: ...Ulthera Control Unit UC 1 Ulthera DeepSEE Handpiece UH 2 Ulthera DeepSEE Transducer DS 7 3 0 UT 1 Ulthera DeepSEE Transducer DS 7 3 0N UT 1N Ulthera DeepSEE Transducer DS 4 4 5 UT 2 Ulthera DeepSEE T...

Page 68: ...ngress protection IPx0 Ordinary Equipment for Control Unit IPx1 for mated transducer and handpiece Mode of operation Continuous IEC60601 1 2 Electromagnetic Compatibility CISPR 11 class A Group 1 IEC6...

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Page 72: ...hera Inc Ulthera Inc 1840 South Stapley Driv e Suite 200 Mesa Arizona 85204 Phone 1 480 619 4069 1 877 858 4372 Ultherapy com Merz Pharmaceuticals GmbH Eckenheimer Landstra e 100 D 60318 Frankfurt am...

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