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vii

 TRUSCULPT OPERATOR MANUAL

D1395, REV. K, 02/18

S

AFETY AND 

R

EGULATORY

 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  35

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Operational Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Operational Safety  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Additional Safety Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Protecting Non-target Tissues  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Electrical Hazard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Fire Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Regulatory Compliance  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Classifications and Compliance‘ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

EMC IEC 60601-1-2:2001 Class A Compliance Statement . . . . . . . . . . . . . . . . . . . . 41

System Labels  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Electromagnetic Compatibility  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

C

LINICAL 

A

PPLICATIONS

 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  47

Indications for Use  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Contraindications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Expected Transient Events and Possible Adverse Effects . . . . . . . . . . . . . . . . . . . . . . . . . 48
Treatment Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Treatment Information  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

S

PECIFICATIONS

 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  51

Input Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Output Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Physical Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
System Environmental Requirements  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

A

PPENDIX 

A - S

YMBOLS

A

PPENDIX 

B - C

UTERA 

D

IRECT 

O

FFICE 

L

OCATIONS

Содержание truSculpt

Страница 1: ...Operator Manual...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

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