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Cellfina Training Reference Guide

The Cellfina System is intended for long-term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females. Safety and effectiveness in other anatomical areas have not been established. The most common side effects reported were soreness, tenderness, and bruising. The Cellfina System is only available through a licensed physician. For full product and safety information, visit Cellfina.com/IFU.

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Cellfina Training Reference Guide

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  1. TREATMENT REFERENCE GUIDE

  2. This reference guide does not replace the Cellfina™ Instructions for Use (IFU). Please reference the IFU for additional information. Copyright © 2015 Ulthera, Inc. Cellfina is a trademark of Ulthera, Inc. in the United States and other countries. Disclaimer This Treatment Reference Guide was current when it was published. Every reasonable effort has been made to assure the accuracy of the information within these pages. The ultimate responsibility lies with readers to ensure they are following the applicable procedures and guidelines correctly. Merz employees, agents and staff make no representation, warranty, or guarantee that this compilation of information is error-free, and will bear no responsibility or liability for the result or consequences of this course. This Treatment Reference Guide is a general summary and explains procedures, principles and guidelines for the proper use of the Cellfina™ System. The Cellfina System is intended for long-term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females. Safety and effectiveness in other anatomical areas have not been established. The most common side effects reported were soreness, tenderness, and bruising. The Cellfina System is only available through a licensed physician. For full product and safety information, visit Cellfina.com/IFU. ii

  3. CELLFINA ™ TREATMENT OVERVIEW Photographs Patient Marking Patient Preparation Anesthesia Delivery Tissue Release & Post-Treatment Care 1

  4. CELLFINA ™ COMPONENTS Setting Up for a Cellfina™ Treatment Prior to beginning a Cellfina™ Treatment, set up all components. 1 Perform the following prior to sterile setup: 2Peel back paper cover; do not touch or contaminate the inner sterile tray. 3 While maintaining sterility, remove inner tray and place on sterile field. Discard tray lid. 4Affix the Anesthesia Needle firmly to the luer of the Anesthesia Handle, ensuring the side holes of the needle are horizontal. 5Insert and lock Anesthesia Guidance Platform tabs into the Vacuum Handpiece. Connect lid, with the 6 mm side facing up. Insert the Disposable Liner into the 1.5 L canister. Remove yellow tubing connector, insert into hole on the Disposable Liner Lid. CAUTION: For your safety, sheath should remain on needle until use. 2

  5. 6 Connect sterile Vacuum Tubing to port on the Vacuum Handpiece. 7 During sterile setup, attach blue connector end of the Vacuum Tubing to the yellow connector port on the Disposable Liner Lid. 8 Unwrap sterile Motor Module cover, invert on fingers of one hand. 10 Attach the Motor Module to the Micro- Blade Assembly. 9 Place Motor Module cover over the disinfected Motor Module, ensuring cover does not wrap below the bottom edge. CAUTION: For your safety, sheath should remain on Micro- Blade until use. 3

  6. CELLFINA ™ COMPONENTS (CONTINUED) Setting Up for a Cellfina™ Treatment 11Power on/off to verify blade reciprocates. 12 Unwrap paper ties from the two Fluid Delivery Syringe Tubings. 13 Connect clear Anesthesia Tubing to open luer. 14 Connect the tubing from the Anesthesia Handle to the Fluid Delivery Syringe Tubing. CAUTION: For your safety, keep fingers and hands away from reciprocating blade while Motor Module is on. 4

  7. 16 Depress the Fluid Delivery Syringe Plunger and repeat until all air is expelled and tubing is primed with the anesthesia fluid. 17Ensure Suction Pump and all connections are in working order. 15 Sterile person hands off tubing spike for non-sterile person to spike IV Bag. Pull back on Fluid Delivery Syringe Plunger to start flow of IV solution. Ensure Foot Vacuum Regulator Pedal is connected. Power on the Suction Pump to test. Note: Tubing to remain primed at all times. 5

  8. PATIENT PHOTOGRAPHY Photography Positions Photograph patient in standing position under downward lighting in at least 5 positions (posterior, left and right profiles, and left and right oblique). Left profile Left oblique Posterior Right oblique Right profile Consistent positioning and lighting is key to effective Cellfina™ photographs: • Camera mounted approximately 29" above the floor and 61" from the patient. • Light source angled 30 degrees downward towards the patient. • The downward lighting aids in the identification and marking of cellulite by casting shadows in the cellulite dimples and depressions. • Include photographs of the anterior thigh if cellulite is present. 6

  9. PATIENT MARKING Marking Technique • Use a water-resistant surgical marking pen. A circle or oval identifies distinct cellulite dimples. • Mark patient in same positions under same lighting as for the photographs. Straight lines mark linear cellulite depressions. • Use the photographs to aid in cellulite identification and marking. A hatched mark identifies a cellulite depression within a longer line. These examples show a current marking best practice. The most important element is to have a consistent way to mark all treatable cellulite. 7

  10. PATIENT TREATMENT Cellfina™ Preparation • Prior to every procedure, confirm that the Cart and Suction Pump are clean and in working order. • The Motor Module and Power Supply should be cleaned and disinfected before and after each treatment by wiping the external surfaces with a standard germicidal wipe per institutional standard practice for the recommended exposure time. See the Cellfina™ Instructions for Use for information on the manual cleaning procedure. • Ensure there is a Disposable Kit and Prep Pack for each patient. 8

  11. ANESTHESIA DELIVERY 1Prep the patient with a disinfecting surgical scrub. 2Turn on the Suction Pump. Set to approximately 40 kPa. 3Confirm that the Anesthesia Guidance Platform is locked into Vacuum Handpiece and the lid is set at the 6 mm depth. 4Place the Vacuum Handpiece on the first area to be anesthetized. 5 Activate the suction with the Foot Pedal, ensuring that the tissue is fully acquired into the Vacuum Handpiece. 8Slide the needle assembly laterally to the furthest delivery track and advance to the end. 6 Remove the protective sheath from the Anesthesia Needle. 9 Deliver 6–8 cc of anesthetic solution, as per physician discretion. 7 Insert the guidepin on the needle assembly into the entry track of the Guidance Platform, advancing to the hard stop. 9

  12. ANESTHESIA DELIVERY (CONTINUED) 10 Retract the needle assembly and slide laterally to the second delivery track. Advance to the end and deliver a second bolus of anesthesia. 14 Reposition the Vacuum Handpiece and repeat the process until the full treatment area is anesthetized. – Whenever possible, position the Vacuum Handpiece so that the needle enters the patient through previously anesthetized areas. – Ensure the anesthesia has generous borders around the treatment area to promote patient comfort. 11Repeat for all four delivery tracks. 12Remove the needle assembly from the Guidance Platform. 13Use the Foot Pedal to release the suction. For patient comfort, insert a finger between the Vacuum Handpiece and the patient’s skin to release the vacuum and more easily remove the Vacuum Handpiece. 15Allow 10–15 minutes of dwell time for the anesthesia to take effect. 10

  13. TREATMENT STRATEGY There are 4 elements involved in treatment strategy: Determining which Guidance Platform to Use 1Determining the Guidance Platform (rectangle or teardrop). 5 tracks 4 tracks Narrow width Wide width 2Identify a partial or complete release. 3Assess the release depth (6 or 10 mm). Rectangle • Most commonly used platform. Its narrow release area minimizes the cutting of tissue. • There are 5 tracks on the rectangle platform. • Use on buttocks and thighs. Teardrop • Wider orientation enables larger release area for capturing clusters of dimples or longer depressions (less commonly used). • There are 4 tracks on the teardrop platform. • The teardrop is not commonly used on the thighs. 4Decide the optimal orientation of the Vacuum Handpiece. 11

  14. TREATMENT STRATEGY (CONTINUED) Identify a Partial or Complete Release The release is determined by the number of tracks on the Guidance Platform required to release the septae band(s). Each track corresponds with the position of the blade, which is indicated on the lid of the Vacuum Handpiece. C P4 P3 P2 P1 When the Micro-Blade Assembly does not travel through all the tracks on the platform, it is a partial (P) release. • P1 is the first track only. • P2 is the first two tracks. • P3 is the first three tracks. • P4 (rectangle only) is the first four tracks. C P3 P2 P1 Moving through all the tracks is a complete (C) release. Partial releases are preferable to minimize the cutting of tissue. 12

  15. Assess the Release Depth (6 mm or 10 mm) The reversible lid determines treatment depth of either 6 or 10 mm. • 6 mm is the default treatment depth. • 10 mm is used to avoid connecting adjacent sites at the same depth or to release deeper cellulite dimples. 6 10 Decide the Optimal Orientation of the Vacuum Handpiece • On the buttocks, orient the Vacuum Handpiece for partial releases when possible. • On the thighs, use a vertical orientation. • For patient comfort, orient the Vacuum Handpiece to release within the anesthetized area. 13

  16. TREATMENT 1Turn on the Suction Pump to approximately 40 kPa. 2Confirm that the desired Guidance Platform is connected to the Vacuum Handpiece and the lid is set for the desired depth. 9If performing a P1 release, turn the Motor Module off on the lateral side of the Guidance Platform. If more tracks are required, leave the Motor Module on and advance the blade assembly to the next track(s). Slide laterally through each desired track(s). Always turn the Motor Module off on the lateral side of the Guidance Platform (example Left-Right- Off). Never retract the blade assembly with the Motor Module on. 3Place the Vacuum Handpiece on the patient. For patient comfort, begin treating in the first area that was anesthetized. 4Activate the suction with the Foot Pedal, ensuring the tissue is fully acquired into the Vacuum Handpiece. 10Remove the blade assembly from the Guidance Platform. 5Remove the protective sheath from the Micro- Blade. 11Use the Foot Pedal to release the suction of the Vacuum Handpiece. For patient comfort, insert a finger between the Vacuum Handpiece and the patient’s skin to release the vacuum and more easily remove the Vacuum Handpiece. 6Insert the blade assembly guidepin into the entry track of the Guidance Platform, advancing to the hard stop. 12Reposition the Vacuum Handpiece and repeat the process until all marked areas are released. 7Turn on the Motor Module. 8Slide the blade assembly laterally through the guidance track. 14

  17. SAFE TREATMENT TECHNIQUES Avoiding Damaged Blades When performing a Cellfina™ Treatment, it is vital to turn the Motor Module OFF on the lateral side of the Guidance Platform after the final release for each treatment area and prior to retracting the blade from the tissue within the Vacuum Handpiece. If the Motor Module is not turned off, the blade continues to reciprocate as it exits the patient, causing the blade tip to hit the hard plastic on either side of the septum. This will bend or damage the blade. OFF on either side prior to returning to the center of the platform after the final release OFF on either side prior to returning to the center of the platform after the final release Left Right If a blade does become damaged or bent: Do NOT attempt to repair the blade. • The Cellfina blade is an extremely sharp, multi-faced blade. • User is risking a laceration by touching the blade. Follow proper Sharps Safety Protocol. • The blade may become damaged or distorted if repaired. Do NOT try to use a bent or damaged blade. • Blade may not perform as intended, resulting in reduced procedure efficacy. • Damaged blade may pose risk to patient. • A distorted blade may damage the septum, resulting in loss of vacuum during the procedure. In the case of a bent or damaged blade, a new Cellfina Blade Assembly must be used to replace the damaged/bent blade. 15

  18. SAFE TREATMENT TECHNIQUES (CONTINUED) Cleaning, Disinfecting, and Device Disposal The Motor Module and Power Supply should be cleaned and disinfected before and after each procedure by wiping the external surfaces with a standard germicidal wipe per institutional standard practice for the recommended exposure time. The Anesthesia Needle Assembly and Micro-Blade Assembly should be disposed of per standard institution or facility biohazard sharps disposal practice. The Vacuum Handpiece and all other accessories should be disposed of per standard institution or facility biohazard practice. Do not reuse the Anesthesia Needle, Micro-Blade or Vacuum Handpiece Assemblies. Never submerge or spray fluids on the Motor Module and Power Supply directly. Periodically inspect the Motor Module and Power Supply (including cords) for visible damage. For full product information, refer to the Cellfina™ Instructions for Use. 16

  19. POST-TREATMENT CARE The following are post-treatment care best practices: • Cleanse the treated area. • Express fluid: – Apply pressure to the treated area on the buttocks and thighs to express excess anesthetic fluid. • Bandage: – Apply sterile absorbent bandages to the treatment site and secure with surgical tape. • Compressive type garments: – Compressive type garments should be worn as often as possible for the first two weeks post-treatment. • Activity: – Light physical activity is allowed in the first 30 days, but extreme physical activity should be avoided during this time. For more detailed information, refer to the Cellfina™ Instructions for Use. 17

  20. ADDITIONAL SUPPLIES In addition to the standard Cellfina™ components, note the following supplies may be required or needed. • Disposable waterproof medical pads • 0.9% Normal Saline (NS) IV bags (minimum 500 cc per patient) • Sterile 4x4 gauze • Physician compounded anesthetic solution • Surgical scrub solution • Sterile ABD pads • Sterile drapes • Surgical tape • Sterile scissors • Compressive type garments • Water resistant surgical markers • Absorbent disposable underwear • Fine tip red and black marker • Blanket and pillow for patient comfort • Sterile gloves 18

  21. NOTES 19

  22. © 2015 Ulthera, Inc. All rights reserved. www.cellfina.com 1006035TRN Rev A

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