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7

TRUSCULPT OPERATOR MANUAL

D1395, REV. K, 02/18

Connecting the Neutral Electrode Cable

Plug the neutral electrode cable connector into the neutral electrode cable receptacle on the side of the 
RF handpiece umbilical connector.

Neutral Electrode Cable Receptacle

WARNING

Before connecting the neutral electrode cable, inspect the cable for 
damage. If it is damaged, do not use the cable and contact Cutera 
Service.

Neutral electrode cable 
receptacle

Summary of Contents for truSculpt

Page 1: ...Operator Manual...

Page 2: ...ed to the original Under US federal law copying includes translations into another language Please note that while every effort has been made to ensure that the data given in this document is accurate...

Page 3: ...tem does cause harmful interference to other devices which can be verified by turning the console off and on the user is encouraged to try to correct the interference by one or more of the following m...

Page 4: ...iv TRUSCULPT OPERATOR MANUAL D1395 REV K 02 18...

Page 5: ...sage Roller 4 Neutral Electrode Cable and Disposable Return Pad 4 System Installation 5 Connecting the RF Handpiece 5 Connecting the Neutral Electrode Cable 7 Connecting the Main Power Cable 8 Filling...

Page 6: ...n 22 Pretreatment Setup 22 Patient Preparation 22 Applying the Disposable Return Pad 23 Starting a Session 24 Completing a Session 26 Using the truGlide Roller 27 MAINTENANCE 29 Troubleshooting Guide...

Page 7: ...1 EMC IEC 60601 1 2 2001 Class A Compliance Statement 41 System Labels 41 Electromagnetic Compatibility 43 CLINICAL APPLICATIONS 47 Indications for Use 47 Contraindications for Use 47 Expected Transie...

Page 8: ...viii TRUSCULPT OPERATOR MANUAL D1395 REV K 02 18...

Page 9: ...tment cycle the RF handpiece is placed and held on the skin while RF generated thermal energy is delivered A return pad returns current to the console At the end of thermal energy delivery the handpie...

Page 10: ...e Other components used for operation such as electrical cables and a supply of disposable return pads are also included truSculpt Console The console consists of the touch screen control panel handpi...

Page 11: ...nt The handpiece on off button activates pauses and deactivates the treatment cycle Colored LED lights on the handpieces illuminate to indicate the following dull green light communication between han...

Page 12: ...d Disposable Return Pad The neutral electrode cable connects to a disposable return pad1 The return pad is intended to safely return the RF current from the patient back to the system through the neut...

Page 13: ...key fill the coolant reservoir Refer to the following sections for detailed system installation instructions Connecting the RF Handpiece Only one RF handpiece can be connected to the console at a time...

Page 14: ...tient 3 Align the umbilical connector over the receptacle on the top console cover 4 Firmly depress the two buttons on either side of the umbilical connector and gently press the connector downwards t...

Page 15: ...nector into the neutral electrode cable receptacle on the side of the RF handpiece umbilical connector Neutral Electrode Cable Receptacle WARNING Before connecting the neutral electrode cable inspect...

Page 16: ...reaker and key are in the OFF position 2 Plug the main power cable into the main power receptacle located on the rear of the console Plug the opposite end of the cable into the power outlet 3 Set the...

Page 17: ...ed to top off the reservoir 1 Turn off the system 2 Remove the reservoir cap and carefully fill the reservoir to the fill line using clean unused distilled water Do not overfill Coolant Reservoir CAUT...

Page 18: ...the pump allowing the water to be drawn into the cooling system 4 Allow the system to run for 5 to 10 seconds 5 Turn the key to the OFF position 6 Carefully top off the reservoir 7 Repeat steps 3 thro...

Page 19: ...t screen appears and the system is automatically placed in STANDBY mode In STANDBY mode the RF handpiece on off button is disabled and no treatment energy is available If a fault condition advisory me...

Page 20: ...some internal circuits remain energized To de energize all the internal circuits turn off the main power circuit breaker and disconnect the power cord from the power outlet Emergency Off In an emerge...

Page 21: ...on Display Screens and Controls Select Screen After system start up the Select screen displays on the touch screen control panel The handpiece model and number of remaining uses display on the screen...

Page 22: ...ment Button on Select Screen To resume a suspended treatment e g in the event of a fault condition that requires restarting the system touch the Resume Treatment button Location of Resume Treatment Bu...

Page 23: ...s disabled and you must replace the handpiece You can request handpiece replacement through the Cutera website www cutera com onlinestore Location of Remaining Uses Indicator on Select Screen NOTE Eac...

Page 24: ...or the pulse duration timer total RF on time total delivered energy and pulse counter reset the pulse duration timer pulse counter and total delivered energy select STANDBY or READY mode go to the Sel...

Page 25: ...s not used for 3 minutes the system automatically enters STANDBY mode To place the system in READY mode touch the green Ready button When the system is in READY mode the Ready button illuminates green...

Page 26: ...at the maximum RF on time of 64 minutes When the timer reaches fifteen minutes the numbers display in orange to alert you that only fifteen minutes of RF on time remain Total delivered energy counter...

Page 27: ...ncounters an error Additionally an audible treatment indicator tone is generated during RF energy delivery The volume of audible tones can be increased from the minimum setting up to a setting at whic...

Page 28: ...ure for all pulses adjust the volume of the treatment indicator and other audible tones adjust the touch screen backlighting view the software version for the system controller display and handpiece g...

Page 29: ...s and refers to the target temperature for the skin and not the measured real time temperature Select the target temperature by touching the and buttons below the C display Target Temperature Display...

Page 30: ...eatment area 2 Ensure that the patient s skin at the treatment site and return pad site is clean of make up and lotions and that there are no objects e g band aids covering the areas 3 Select a return...

Page 31: ...with no creases or bubbles 4 Open the clamp on the neutral electrode cable by lifting the latch 5 Insert the return pad tab completely into the clamp with the foil contacts facing up so that the entir...

Page 32: ...for detailed information on recommended treatment parameters treatment technique and post treatment care WARNING To prevent the neutral electrode cable and return pad from being pulled off of the pat...

Page 33: ...discomfort or heat in the return pad area pause the treatment and verify that the return pad is properly adhered to the skin The pad must be in complete contact with the skin with no creases or bubbl...

Page 34: ...n pad from the patient s skin 4 Dispose of the return pad 5 Disinfect the RF handpiece as described in the Maintenance chapter of this manual 6 To begin a new treatment touch the New Treatment button...

Page 35: ...area prior to and or following RF treatment Massage the entire treatment area thoroughly with the truGlide roller Use moderate pressure to ensure the desired smoothing is achieved Massage entire area...

Page 36: ...28 TRUSCULPT OPERATOR MANUAL D1395 REV K 02 18...

Page 37: ...tion 2 System console electrical Verify that the system is on and properly connected to an electrical service outlet Electronic Fault Detection Circuitry If the console electronic system detects a fau...

Page 38: ...ing error code displays on the touchscreen Probable Cause The RF handpiece is damaged Suggestion Contact Cutera for handpiece replacement Probable Cause Incorrect settings or treatment technique Sugge...

Page 39: ...and corresponding error code displays on the touchscreen Probable Cause The handpiece on off button was pressed while attempting to place the system in READY mode Suggestion Ensure that the handpiece...

Page 40: ...roubleshooting Guide section or if the suggested solutions do not resolve the problem contact Cutera Service NOTE If an error cannot be cleared or if an error persists or reappears note the error code...

Page 41: ...andpiece and truGlide massage roller after each patient 1 Wipe down the external surfaces of the handpiece with the exception of the RF electrode with a damp cloth and mild detergent 2 Gently dab the...

Page 42: ...he Terms and Conditions of Sale Product Complaints All questions or concerns related to the quality reliability and or durability of this product should be directed to Cutera Customer Service or to an...

Page 43: ...cal observation and appropriate clinical endpoints Operational Training The truSculpt system should be operated only by qualified personnel who have received appropriate training in the use of the sys...

Page 44: ...edia e g sterile water dextrose air gas glycine etc WARNING The handpiece is a sensitive instrument and should not be dropped If the handpiece is dropped carefully examine it for any physical damage p...

Page 45: ...CAUTION The system should always be in STANDBY mode until the handpiece is safely positioned at the area to be treated CAUTION Remove the RF handpiece from the treatment site when not in use even temp...

Page 46: ...nel WARNING For procedures where the RF current could flow through parts of the body having a relatively small cross sectional area the use of bipolar techniques may be desirable to avoid unwanted tis...

Page 47: ...tem turned off and disconnected from the power source WARNING The system is grounded through the grounding conductor in the power cord Grounding is essential for safe operation WARNING Do not connect...

Page 48: ...ergy WARNING There is a risk of pooling of flammable solutions under the patient or in body depressions such as the umbilicus and in body cavities Any fluid pooled in these areas should be mopped up b...

Page 49: ...IEC 60601 2 2 Edition 5 0 2009 EMC IEC 60601 1 2 2001 Class A Compliance Statement The truSculpt system is suitable for use in all establishments other than domestic and those directly connected to th...

Page 50: ...ulpt RF Output TSXXXXX YYYY MM DD Brisbane CA 100 240 V 900 VA 50 60 Hz 1 MHz 300 W max 100 200 MDSS GmbH Schiffgraben 41 D 30175 Hannover Germany USA Rx only Keyswitch Label next to keyswitch Tilting...

Page 51: ...observe and verify normal operation of the system in the configuration in which it will be used prior to using it in a surgical procedure Consult the tables below for guidance in placing the truSculp...

Page 52: ...ential mode 2kV common mode 0 5 1kV differential mode 0 5 1 2kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and volt...

Page 53: ...ths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment...

Page 54: ...transmitter Separation distance m according to frequency of transmitter 150 kHz to 80 MHz d 1 17 P 80 MHz to 800 MHz d 1 17 P 800 MHz to 2 5 GHz d 2 33 P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17...

Page 55: ...orary reduction in the appearance of cellulite Contraindications for Use Pregnancy Cardiac pacemakers or internal defibrillators Infections or open wounds in the treatment area Do not treat over and d...

Page 56: ...diac pacemakers or other active implants a possible hazard exists because interference with the action of the pacemaker may occur or the pacemaker may be damaged In case of doubt approved qualified ad...

Page 57: ...treated before returning to a previously treated area When moving the handpiece to the next area to be treated allow no more than 20 50 overlap from the previous location CAUTION Anesthetics should n...

Page 58: ...50 TRUSCULPT OPERATOR MANUAL D1395 REV K 02 18...

Page 59: ...2 18 Specifications Input Power Requirements Output Power NOTE Specifications are subject to change without notice Voltage Frequency Power 100 240 V 50 60 Hz 900 VA RF output Voltage range Max output...

Page 60: ...e weight 2 lb 0 9 kg Treatment spot size truSculpt 16 truSculpt 40 16 cm2 40 cm2 Handpiece cradle weight 1 lb 0 45 kg Power cable length 10 ft 3 m Umbilical cable length 6 5 ft 2 m Operational Maximum...

Page 61: ...el at circuit breaker and control panel next to keyswitch 417 5104 Momentary start Control panel next to keyswitch DIN 18734 Emergency OFF Control panel next to red button 417 5266 Standby Touchscreen...

Page 62: ...screen display Cutera defined Pulse counter Touchscreen display Cutera defined Average pulse duration Touchscreen display Cutera defined Total delivered energy Touchscreen display Cutera defined Volum...

Page 63: ...facturer Rear panel label and RF handpiece ID label BS EN ISO 15223 1 Authorized representative in the European Community Rear panel label MDD 93 42 EEC CE Mark Rear panel label and return pad pouch c...

Page 64: ...0601 HF isolated patient circuit RF handpiece umbilical connector and rear panel label IEC 60601 RF energy RF handpiece on off button IEC 60601 Tilting hazard do not push the console from the side Sid...

Page 65: ...TERA within US or 415 657 5500 outside US Service 866 258 8763 within US or 415 657 5500 outside US Fax 415 330 2444 Cutera APAC Cutera K K Shibuya Infoss Annex Bldg 3rd fl 12 10 Sakuragaoka Shibuya k...

Page 66: ...B 2 TRUSCULPT OPERATOR MANUAL D1395 REV K 02 18...

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