Cutera truSculpt Operator's Manual
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Cutera truSculpt Operator's Manual

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Body House
February 12, 2025

Hello, good time Our Trusculpt ID device gave errors 272, 802, 804 and 995. We turned the device on and off and now it shows error 002, what happened?

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Summary of Contents for Cutera truSculpt

  • Page 1 Operator Manual...
  • Page 2 This manual is copyrighted with all rights reserved. Under copyright laws, this manual may not be copied in whole or in part or reproduced in any other media without the express written permission of Cutera, Inc. Permitted copies must carry the same proprietary and copyright notices as were affixed to the original.
  • Page 3 The Cutera truSculpt system has been tested and found to comply with the limits for medical devices to IEC/EN 60601-1-2:2001. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. The truSculpt system generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity.
  • Page 4 TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...

  • Page 5: Table Of Contents

    RF Handpieces ........
  • Page 6 End of Life Disposal - Environmental Information ....... .34 TRUSCULPT OPERATOR MANUAL...
  • Page 7 System Environmental Requirements ........52 A - S PPENDIX YMBOLS B - C PPENDIX UTERA IRECT FFICE OCATIONS TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...
  • Page 8 TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...

  • Page 9: Ntroduction

    In addition, the truGlide massage roller is intended to provide a temporary reduction in the appearance of cellulite. The truSculpt consists of a console, a truGlide massage roller, and one or more RF handpieces that connect to the console with an umbilical cable. All system functions are controlled through the console.

  • Page 10: Trusculpt Components

    Components The truSculpt consists of a console with a touch screen control panel, one or more RF handpieces, a truGlide massage roller, a handpiece cradle, and a neutral electrode cable. Other components used for operation, such as electrical cables and a supply of disposable return pads, are also included.
  • Page 11 RF Handpieces Two RF handpieces are available for use with the truSculpt: truSculpt 16, which features a 16 cm concave electrode, and truSculpt 40, which features a 40 cm concave electrode. The RF handpieces deliver RF energy to the skin and subcutaneous tissue during treatment.

  • Page 12: Truglide Massage Roller

    RF current from the patient back to the system through the neutral electrode cable. CAUTION Cutera provides a supply of disposable return pads with each truSculpt system or replacement RF handpiece. To ensure safe system operation, use only Cutera-supplied return pads.

  • Page 13: System Installation

    System Installation The truSculpt is shipped directly from the factory to your site. It is important that your staff be experienced with the appropriate performance and safety considerations. Training associated with the system and handpieces is available. Contact Cutera for information.
  • Page 14 Firmly depress the two buttons on either side of the umbilical connector, and gently press the connector downwards to align the fittings. Press firmly until you hear two clicks. CAUTION To ensure proper handpiece engagement, always listen for two clicks when installing the RF handpiece. Buttons TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...

  • Page 15: 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. 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...

  • Page 16: Connecting The Main Power Cable

    Plug the opposite end of the cable into the power outlet. Set the circuit breaker to the (ON) position. Main power circuit breaker Main power receptacle Main Power Receptacle and Circuit Breaker TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...

  • Page 17: Filling The Coolant Reservoir

    Filling the Coolant Reservoir The truSculpt console requires clean distilled water as a coolant. The coolant reservoir is located on the rear of the console. Occasionally, distilled water may need to be added to top off the reservoir. CAUTION Permanent damage to internal components will occur if improper coolant is used.
  • Page 18 Turn the key to the (OFF) position. Carefully top off the reservoir. Repeat steps 3 through 6 until the reservoir is full. NOTE The coolant capacity of the system is approximately 1 liter. Replace the reservoir cap. TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...

  • Page 19: System Basics

    (ON) position or the (START) position, and the system will only operate with the key in place. When treatments are complete or the system is not in use, always remove and store the key. TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...

  • Page 20: Restarting The System

    If the system shuts down during operation (due to electrical power loss or depression of the Emergency OFF button), you must manually restart the system using the key. The system internal memory will recall the most recent operating parameters upon restart. TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...

  • Page 21: Peration

    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. truSculpt 16 Select Screen truSculpt 40 Select Screen TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...
  • Page 22 To resume a suspended treatment (e.g., in the event of a fault condition that requires restarting the system), touch the “Resume Treatment” button. Touch to go to RF Handpiece Control screen and resume treatment Location of “Resume Treatment” Button on Select Screen TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...

  • Page 23: Remaining Uses Indicator

    The Remaining Uses indicator displays the number of RF treatments remaining before handpiece replacement is required. The truSculpt 16 and truSculpt 40 are limited to 51 uses. When five uses remain, the indicator changes from green to yellow. When zero uses remain, the “New Treatment” button is disabled, and you must replace the handpiece.

  • Page 24: Rf Handpiece Control Screen

    Pulse duration timer Total delivered energy and reset button Standby button Ready button Total “RF on” timer Pulse counter and reset button RF Handpiece Control Screen (STANDBY Mode shown) TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...

  • Page 25: Ready And Standby Modes

    RF handpiece on/off button is enabled. When the on/off button is pressed, RF energy delivery is initiated. Standby button Ready button RF Handpiece Control Screen (READY Mode shown) TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...

  • Page 26: Displays And Indicators

    Displays and Indicators The truSculpt uses the following indicators and controls to ensure safe and accurate operation: Real-time temperature: displays real-time temperature feedback of the skin, measured in degrees Celsius. Pulse duration timer: counts down the pulse duration, in minutes and seconds.

  • Page 27: Audible Tones

    Audible Tones The truSculpt system console emits different audible tones when: • a control screen selection is made • the handpiece on/off button is pressed to start RF energy delivery • the system encounters an error Additionally, an audible treatment indicator tone is generated during RF energy delivery.

  • Page 28: Information & Adjustment Screen

    Go to RF Handpiece Control screen Total “RF on” time Average pulse duration Pulse counter Total delivered energy Average maximum temperature for all pulses Backlighting controls Volume controls Software versions Information & Adjustment Screen TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...

  • Page 29: Selecting Treatment Parameters

    Pulse duration is measured in minutes and seconds and refers to the length of time RF energy is delivered to the patient. Select the pulse duration by touching the buttons below the “min:sec” display. Pulse Duration Display and Controls TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...

  • Page 30: Performing An Rf Treatment Session

    Performing an RF Treatment Session Pretreatment Setup Prior to each use, inspect the truSculpt system components and cables for dirt, debris, or damage. CAUTION The RF electrode is covered with proprietary film. Inspect the film to ensure that there are no scratches, imperfections, or defects.

  • Page 31: Applying The Disposable Return Pad

    Insert the return pad tab completely into the clamp, with the foil contacts facing up, so that the entire foil-contact area is covered by the clamp. Lower the latch until it is level with the body of the clamp. TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...

  • Page 32: Starting A Session

    Starting a Session Set the Target Temperature and Pulse Duration. Refer to the truSculpt Treatment Guidelines accompanying this manual 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 patient, position the cable so that there is no tension on the cable.
  • Page 33 CAUTION To help reduce the risk of adverse events, ensure that the treatment area is dry and that the electrode is in full contact with the skin prior to each imprint. TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...

  • Page 34: Completing A Session

    “Resume Treatment” button on the Select screen to return to the RF Handpiece Control screen, and then touch the tab to go to the Information & Adjustment screen. TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...

  • Page 35: Using The Truglide Roller

    Massage the entire treatment area thoroughly with the truGlide roller. Use moderate pressure to ensure the desired smoothing is achieved. Massage entire area for 5-10 minutes, or until the desired improvement is reached. NOTE Store the truGlide roller in the handpiece cradle when not in use. TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...
  • Page 36 TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...

  • Page 37: Aintenance

    READY mode and treatment energy are not available until the fault condition is cleared. Refer to the Possible Problems and Solutions section on the following page for information on clearing the fault condition. TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...

  • Page 38: Possible Problems And Solutions

    Suggestion Contact Cutera for handpiece replacement. Probable Cause Incorrect settings or treatment technique. Suggestion Refer to the truSculpt Treatment Guidelines. “Water Low” pop-up screen and corresponding error code displays on the touchscreen. Probable Cause The system is low on water.
  • Page 39 The handpiece on/off button was pressed while attempting to place the system in READY mode. Suggestion Ensure that the handpiece on/off button is not pressed before touching the READY button on the RF Handpiece Control screen. TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...

  • Page 40: Error Code Guide

    Cutera Service. Below is a brief explanation of some of the codes that may be seen in the advisory pop-up screen. If you have any questions about this information or the operation and service of your system, contact Cutera Service.

  • Page 41: Annual System Maintenance

    Preventive maintenance, safety, and power checks should be performed annually by a Cutera representative to ensure proper system performance. System Repair All system repairs should be performed by a Cutera-certified service engineer. For training and information, contact your local Cutera representative. User Maintenance Cleaning the Console Clean the outer surfaces of the console with a damp cloth and mild detergent.

  • Page 42: Cleaning The Neutral Electrode Cable

    End of Life Disposal - Environmental Information The truSculpt system must be disposed of according to local laws and hospital practices. This product is considered electronic equipment and must not be disposed of as unsorted municipal waste and must be collected separately.

  • Page 43: Afety And Egulatory

    Introduction The truSculpt, when properly used by trained personnel, is a safe and effective instrument for indicated clinical treatments. Keep in mind that safe operation requires a thorough understanding of the system and safety features as described in this operator manual.

  • Page 44: Operational Safety

    WARNING The output from the active electrode may change during use. WARNING Do not use the truSculpt system with non-conductive media (e.g., sterile water, dextrose, air, gas, glycine, etc.). WARNING The handpiece is a sensitive instrument and should not be dropped.
  • Page 45 Ensure that the power cable plug is properly connected to the console receptacle. CAUTION The truSculpt is designed to be operated exclusively as a unit. Only use accessories provided by Cutera. CAUTION Cutera fully warrants the safety and efficacy of our devices when used as intended for indications for which they are approved.

  • Page 46: Additional Safety Considerations

    Electrical Hazard WARNING High voltages are present inside the system. Do not remove the exterior housing. WARNING Only an authorized Cutera Service Representative should perform service on any Cutera console or handpiece. TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...
  • Page 47 The system is grounded through the grounding conductor in the power cord. Grounding is essential for safe operation. WARNING Do not connect wet components to the truSculpt console. WARNING Do not allow fluid to contact any electrical connectors on the truSculpt components or cables during use.

  • Page 48: Fire Hazard

    Do not place active accessories near or in contact with flammable materials (e.g., gauze, surgical drapes, etc.). WARNING Observe fire precautions at all times. Heating associated with RF energy may be an ignition source. TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...

  • Page 49: Regulatory Compliance

    Regulatory Compliance Classifications and Compliance The truSculpt system is a Class II medical device as defined by the US Code of Federal Regulations and a Class IIb device as defined by the European Communities Medical Device Directive. The truSculpt complies with the following standards: •...
  • Page 50 Schiffgraben 41, D-30175 Hannover. Germany Rx only , USA Rear Panel Label Keyswitch Label Tilting Hazard Label HF Isolated Patient Circuit (next to keyswitch) (on sides of system console) (on side of umbilical connector) TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...

  • Page 51: Electromagnetic Compatibility

    Guidance and Manufacturer’s Declaration: Electromagnetic Emissions The truSculpt system is intended for use in the electromagnetic environment specified below. The customer or the user of the truSculpt system should ensure that it is used in such an environment.
  • Page 52 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The truSculpt system is intended for use in the electromagnetic environment specified below. The customer or the user of the truSculpt system should ensure that it is used in such environment. Electromagnetic Environment: Immunity Test...
  • Page 53 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The truSculpt system is intended for use in the electromagnetic environment specified below. The customer or the user of the truSculpt system should ensure that it is used in such an environment. Immunity Test...
  • Page 54 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the truSculpt System The truSculpt system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the truSculpt system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the truSculpt system as recommended below, according to the maximum output power of the communications equipment.

  • Page 55: Linical Pplications

    Indications for Use The truSculpt RF energy is intended to provide topical heating for the purpose of elevating tissue temperature for body sculpting, body contouring, fat reduction, and circumferential reduction. The truGlide massage roller is intended to provide a temporary reduction in the appearance of cellulite.

  • Page 56: Expected Transient Events And Possible Adverse Effects

    (i.e., drug that kills bacteria and other germs). There is a risk of scarring if the area becomes infected and is not properly taken care of. Treatment Precautions The truSculpt should only be operated by qualified personnel who have received appropriate training. The following safety precautions are recommended: WARNING...

  • Page 57: Treatment Information

    Treatment Information For treatment-specific guidelines, refer to the truSculpt Treatment Guidelines accompanying this operator manual. These guidelines can also be obtained from your local Cutera representative or on the Cutera website. Patient Information Prior to treatment, conduct a patient consultation.
  • Page 58 TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...

  • Page 59: Pecifications

    Specifications are subject to change without notice. Input Power Requirements Voltage 100-240 V~ Frequency 50/60 Hz Power 900 VA Output Power RF output 1 MHz Voltage range 250 Vrms max 300 W max @ 100-200  Max. output power TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...

  • Page 60: Physical Parameters

    Maximum operating altitude 15,000 ft (4572 m) Operating temperature 5° to 30°C Humidity 0 to 90%, non-condensing Non-operational Altitude 50,000 ft (15240 m) Temperature –10° to 50°C, coolant drained Humidity 0 to 90%, non-condensing TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...
  • Page 61 Symbols This appendix describes the truSculpt system symbols and their meanings and locations. Standard Symbol Description Location Reference Cutera logo Control panel 417-5007 Mains ON Rear panel (at circuit breaker) and control panel (next to keyswitch) 417-5008 Mains OFF Rear panel (at circuit breaker)
  • Page 62 Cutera-defined Total delivered energy Touchscreen display Cutera-defined Volume of audible tones and Touchscreen display indicators Cutera-defined Touchscreen backlighting Touchscreen display Cutera-defined System controller software version Touchscreen display Cutera-defined Handpiece software version Touchscreen display TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...
  • Page 63 Rear panel label 15223-1 WEEE Directive Waste of electrical and electronic Rear panel label equipment must not be disposed as unsorted municipal waste and must be collected separately. IEC 60601 Non-ionizing radiation Rear panel label TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...
  • Page 64 Single use Return pad pouch 15223-1 BS EN ISO Do not use if package is opened or Return pad pouch 15223-1 damaged BS EN ISO Consult instructions for use Return pad pouch 15223-1 TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...
  • Page 65 Cutera Direct Office Locations Cutera World Headquarters Cutera, Inc. 3240 Bayshore Boulevard Brisbane, CA 94005 Telephone: (888) 4-CUTERA or (415) 657-5500 (within US) (outside US) Service: (866) 258-8763 (within US) or (415) 657-5500 (outside US) Fax: (415) 330-2444 Cutera (APAC) Cutera K.K.
  • Page 66 TRUSCULPT OPERATOR MANUAL D1395, REV. K, 02/18...

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