FCC ID: 2AUPV-830-00013 RFID Reader

Cytrellis ellacor System with Micro-Coring Technology Operators Manual Cytrellis Biosystems, Inc. 299C Washington Street Woburn, MA 01801, USA

(857) 254 1720 LBL-00029 Rev 011 1 LBL-00029 Rev 011 Contents Welcome ............................................................................................................................. 5 Copyright & Patent Information ............................................................................................... 5 Ellacor System ........................................................................................................................ 5 Ellacor System (Front/Left Side View) ............................................................................. 6 Ellacor System (Side/Rear View) ..................................................................................... 7 Handpiece .......................................................................................................................... 8 Single-Use Needle Cartridge .............................................................................................. 9 Warranty Information ............................................................................................................ 10 Ordering Replacement Components ...................................................................................... 10 Contacting Cytrellis ................................................................................................................. 10 Equipment Returns ................................................................................................................. 10 End of Life Disposal - Environmental Information ................................................................. 11 Manual Conventions .............................................................................................................. 11 Symbols Used in This Guide ................................................................................................... 11 Built-in Help ............................................................................................................................ 12 Ellacor System Setup ....................................................................................................... 13 Choosing the Best Location for the ellacor System ............................................................. 13 Connecting the System Components ..................................................................................... 13 Clinical Applications ........................................................................................................... 16 Contraindications ................................................................................................................... 16 Treatment Precautions ........................................................................................................... 17 Risks and Benefits ................................................................................................................... 18 Uncommon Side Effects ................................................................................................... 18 Benefits ............................................................................................................................ 18 Setting up the Treatment Area ........................................................................................... 19 Staging User-Supplied Items .................................................................................................. 19 Standard Facility Supplied Items ...................................................................................... 19 Treatment Specific User-Supplied Items .......................................................................... 19 Positioning the System ........................................................................................................... 20 Turning on the System ........................................................................................................... 20 Preparing the System for Use ................................................................................................. 23 Attaching the Suction Tubing to the Handpiece Cable ..................................................... 23 Attaching the Suction Tubing to the Vacuum Filter .......................................................... 24 2 LBL-00029 Rev 011 Attaching the Vacuum Filter to the Console ..................................................................... 25 Installing and Locking the Single-Use Needle Cartridge onto the Handpiece .................. 26 Treatment Screen ............................................................................................................. 32 Treatment Instructions....................................................................................................... 36 Replacing the Needle Cartridge During Treatment ................................................................ 43 Post-treatment Clean-up Instructions ................................................................................. 44 Post-Treatment Clean-Up ....................................................................................................... 46 Cleaning the Handpiece ................................................................................................... 46 Disinfecting the Handpiece .............................................................................................. 49 Cleaning the System Console ........................................................................................... 50 Cleaning the Touchscreen Display ................................................................................... 50 Turning Off the System ........................................................................................................... 51 Disconnecting the System Components ................................................................................. 53 Moving the System ................................................................................................................. 54 Maintenance ..................................................................................................................... 55 System Maintenance .............................................................................................................. 55 Replacing the Fuses ................................................................................................................ 55 Appendix A System Specifications ...................................................................................... 56 Appendix B Safety and Regulatory Compliance ................................................................... 57 General Safety and Regulatory Information .......................................................................... 57 Electrical Hazards ................................................................................................................... 57 Additional Safety Considerations ........................................................................................... 58 Regulatory Compliance Safety Features ................................................................................ 59 Needle Penetration Hard-stop ......................................................................................... 59 Electrical Fault Detection Circuitry ................................................................................... 59 Location and Definition of Regulatory and Other System Labels .................................... 59 Label Symbols ......................................................................................................................... 60 FCC Information...................................................................................................................... 62 Wireless Technologies ............................................................................................................ 64 Near Field Communication (NFC) Device ......................................................................... 64 Wireless and Cellular Module .......................................................................................... 65 Electromagnetic Compatibility ............................................................................................... 67 Clinical Summary .................................................................................................................... 72 Appendix C Error Codes, Messages, & Troubleshooting ....................................................... 74 Cytrellis ellacor System with Micro-Coring Technology Operators Manual 3 4 This page intentionally left blank. LBL-00029 Rev 011 Welcome The Cytrellis ellacor System with Micro-Coring Technology removes unwanted skin on the microscale without evidence of scarring or thermal damage to the tissue. Our specially designed skin-coring mechanism precisely controls location and depth of hollow coring needles to rapidly excise full thickness micro-columns (cores) of the dermal and epidermal tissue. The tissue columns are subsequently removed from the needles via the integrated suction system. The system provides a wide range of <skin removal percentages> and <core excision depths> settings to be customized to meet your patients needs. Copyright & Patent Information This manual is copyrighted with all rights reserved. Under the 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 Cytrellis Biosystems. Permitted copies must carry the same proprietary and copyright notices as were affixed to the original under the law. Copying includes translation into another language. Cytrellis Biosystems, Cytrellis, the Cytrellis logo, ellacor, the ellacor logo and Micro-Coring are trademarks or registered trademarks of Cytrellis Biosystems, Inc. All other trademarks are the intellectual property of their respective owners. Patents: www.cytrellis.com/patents Ellacor System with Micro-Coring Technology Ellacor System ships in a crate and includes the following components:

Handpiece System Console Footswitch Power Cable/Accessories Product Information Cytrellis ellacor System with Micro-Coring Technology Operators Manual 5 Ellacor System (Front/Left Side View) Figure 1. Ellacor System Front/Left Side View Touchscreen allows practitioners to select treatment settings and view system status information. Power Button turns the System on and off. Handpiece positions and actuates the needle(s) of the sterile Single-Use Needle Cartridge into the tissue. Footswitch is used to initiate treatment patterns. Vacuum (internal component) provides suction to stabilize the treatment area and assist in removing cores of tissue from the needles. Suction Tubing (commercially available) is used to connect the vacuum from the Console to the Needle Cartridge. Handpiece Cable Receptacle is used to connect the Handpiece to the Console. Vacuum Filter (commercially available) collects tissue and bodily fluids from the treatment site to prevent contamination to the system. Mobile Cart Handle is used to position the cart. LBL-00029 Rev 011 6 Ellacor System (Rear/Left Side View) Figure 2. Ellacor System Rear/Left Side View Power Cable Wrap is used to store the Console Power Cable and Footswitch Cable when the Console is not in use. Footswitch Cable Receptacle is used to connect the Footswitch to the Console. Power Cable Receptacle is used to connect the System to a power source. Potential Equalization Conductor is used to attach third-party tools for grounding. Footswitch Mount is used to store the Footswitch when not in use. Mobile Cart Wheels give users the ability to move the System. Wheel Locking Tabs secure the Mobile Cart, so it does not move during treatment. Handpiece Cable Hanger is provided on both the left and right side of the System Console for stowing the Handpiece Cable. Handpiece Holster is provided on both the left and right side of the System Console for stowing the Handpiece. Cytrellis ellacor System with Micro-Coring Technology Operators Manual 7 Handpiece Figure 3. EllacorHandpiece Handpiece Actuator moves the needle(s) to deliver the intended treatment pattern and core depth settings. Handpiece Light illuminates the treatment area. Handpiece Head is used to align and secure the Needle Cartridge to the Handpiece. Cleaning Cover is used to prevent fluid ingress to the Handpiece during the cleaning and disinfecting process. Tubing Clip is used to secure the Suction Tubing to the Handpiece Cable. Handpiece Cable plugs into the Handpiece Cable Receptacle to provide power to the Handpiece. Handpiece Grip provides a location to hold the Handpiece while treating. 8 LBL-00029 Rev 011 Single-Use Needle Cartridge Figure 4. Single-Use Needle Cartridge Distance Spacer aligns the position of the treatment pattern and delivers suction to stabilize the treatment area. Needle(s) are used to core the treatment area. Needle Hub contains the needle(s) and attaches to the Handpiece Actuator. Needle Cartridge Tubing provides suction to the Distance Spacer and needle(s). Needle Cartridge Connector connects the Suction Tubing to the Needle Cartridge Tubing. Needle Cartridge Lock locks the Needle Cartridge to the Handpiece. Cytrellis ellacor System with Micro-Coring Technology Operators Manual 9 Warranty Information For specific and detailed warranty information for the ellacor System, please refer to Cytrellis Terms and Conditions. Ordering Replacement Components Table 1. Consumable Components Component Size Single Use Needle Cartridge1 Vacuum Filter1 Triple Needle Cartridge (10x10 mm) Cytrellis 5-micron Vacuum Filter with standard connection for 1/4" diameter Suction Tubing2 Vacuum-rated Suction Tubing1 1/4 (6.35 mm) inner diameter, 6 ft.

(1.83 m) with easy grip ends Fuse 5x20mm, 10 A, 250 VAC fuses. (Type: CER, Slow; Breaking Capacity: 1.5kA) Local Hardware Store Available From Medical Supplier Medical Supplier 1These components must be replaced after each treatment. 2 Filters can also be ordered via the following online resource:

https://shippertmedical.com/products/replacement-biofilter CAUTION US federal law restricts the sale of this device to or by the order of a practitioner licensed by the law of the state in which he/she practices to use or order the use of the device; and the method of its application or use. To reorder Single-Use Needle Cartridges or for other assistance, contact Cytrellis Customer Service at (857) 254-1720 or www.cytrellis.com. Contacting Cytrellis Equipment Returns For all equipment returns, contact Cytrellis for a Return Goods Authorization (RGA) number and return instructions. 10 LBL-00029 Rev 011 End of Life Disposal - Environmental Information The ellacor System (Console, Footswitch, Handpiece, and Needle Cartridges) must be disposed of according to local laws and hospital practices. This product is considered medical equipment and must not be disposed of as unsorted municipal waste and must be collected separately. Please contact the manufacturer or other authorized disposal company to decommission your equipment. Manual Conventions While every effort has been made to ensure that the data given in this document is accurate, the information, figures, illustrations, tables, specifications, and schematics contained herein are subject to change without notice. The following conventions are used in this manual:

Information that is displayed on the screen appears in the Courier New font. Buttons to be pressed appear in BOLD. Web addresses appear in blue font and are underscored. Variables, actions are represented within <brackets>. When you see a setting contained in a bracket there are other values that can be used as well. And finally, a vertical bar ( | ) is used to separate actions. Symbols Used in This Guide Table 2. Symbols Used in This Guide Symbol Definition Actions to be performed by the user are distinguished by a number or the STEP text box. Supplemental/helpful details are provided in Notes indicated by the information symbol. When this symbol appears, cautionary guidance follows. When this symbol appears, the information contained in the warning/alert must be followed to avoid harm to either the operator or patient. Cytrellis ellacor System with Micro-Coring Technology Operators Manual 11 Built-in Help The ellacor System Help Screen displays an image describing how to perform the corresponding task on the Touchscreen when a Help button is pressed. To access the ellacor System Help Screen, press the Help button, shown as a question mark, located next to the corresponding task. Figure 5. Sample Help Screen To close the ellacor System Help Screen, press the CLOSE button. 12 LBL-00029 Rev 011 System Setup The ellacor System with Micro-Coring Technology is intended for use by qualified personnel in a physicians office, clinic, or hospital and shall not be used near HF Surgical Equipment or the RF shielded room of Magnetic Resonance Imaging (MRI) Equipment. Proper System operation requires the selection of a well-ventilated space in a temperature-controlled environment. The System functions at ambient temperatures between 15C (59F) and 30C (86F), with controlled relative humidity between 20% and 80% non-condensing. A correctly grounded power connection is required for safe System operation. Therefore, it is mandatory that the AC wall power outlet is correctly grounded and is rated for the electrical load of the system. Follow local electrical codes to ensure proper grounding of the AC wall power outlet. Choosing the Best Location for the ellacor System The ellacor System is designed to work with left and right-handed practitioners. When choosing the best site for setting up the ellacor System, consider the following:

1. Position the console at the desired location, at least 20 cm (8 in) from walls, furniture, or other equipment. 2. Place the unit within 1.75 m (5 ft 9 in) of the AC outlet to be used. 3. Use a floor cable cover to prevent a tripping hazard if the system is located in an area with heavy foot traffic. 4. Ensure that the exhaust vent on the rear of the console is not blocked. Adequate space around the console ensures proper air circulation. Connecting the System Components 5. To avoid electrical shock and fire hazards, inspect the Power Cable, Footswitch Cable, and Handpiece Cable to ensure they are not frayed or split. 6. To ensure proper operation, examine the Handpiece and Footswitch for damage. If all the components are in good working order continue with these instructions. If a component is damaged, do not use the System. Contact Cytrellis Biosystems, Inc. for further instructions. Cytrellis ellacor System with Micro-Coring Technology Operators Manual 13 14 7. Plug the Handpiece Cable into the Handpiece Cable Receptacle on the front of the System Console. The red dot on the Handpiece Cable should always be facing upwards. Figure 6. Handpiece Cable Plugged into Handpiece Cable Receptacle NOTE If the Handpiece is NOT properly connected, an error displays on the Touchscreen when the system is turned on. 8. Place the Handpiece in the holster on either side of the console and hang the Handpiece Cable on the Cable Hanger. Figure 7. Handpiece in Holster; Cable on Cable Hanger LBL-00029 Rev 011 9. Plug the Footswitch Cable into the Footswitch Cable receptacle on the rear of the System Console. To do so, align the cable and port key features, insert the cable to the port, and spin the locking rings in a clockwise direction. Figure 8. Connecting the Footswitch Cable Key Feature Key Feature Footswitch Side Console Side 10. Insert the receptacle end of the Power Cable into the Power Cable Receptacle on the rear of the System Console and insert the Power Cable plug into an AC wall power outlet that is correctly grounded and is rated for the electrical load of the system. CAUTION Only use the hospital-grade power cord provided with the System when connecting the console. 11. Position the console at the desired location, at least 20 cm (8 in) away from walls, furniture, or other equipment. Ensure that the exhaust vent on the rear of the console is not blocked. Adequate space around the console ensures proper air circulation. WARNING To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. 12. Engage the Wheel Locks by pressing down on the Locking Tabs. Cytrellis ellacor System with Micro-Coring Technology Operators Manual 15 Clinical Applications The ellacor System with Micro-Coring Technology is indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years old with Fitzpatrick skin types I-IV. CAUTION A pertinent medical history should be obtained prior to treating to determine whether the patient is an appropriate candidate for treatment with the ellacor System with Micro-Coring Technology. NOTE This product is not intended for transdermal (under the skin) delivery of topical products such as cosmetics, drugs, or biologics. Contraindications The ellacor System with Micro-Coring Technology should not be used for the treatment of:

Areas of skin with dermatosis, e.g. skin tumors, keloids or in case of predisposition to keloids, solar keratosis, warts, or birthmarks The area within the bony orbital rim Mucous membranes Areas where silicone or synthetic material is implanted The ellacor System with Micro-Coring Technology should not be used on patients that:

Are pregnant or nursing mothers Are suffering from open wounds, sores, or irritated skin in the treatment area Have an allergy to stainless steel Have an allergy to topical, oral, or injected medications or preparations that may be used during the procedure, such as petrolatum, lidocaine, bupivacaine, chlorhexidine, or povidone-iodine Have a history or presence of any clinically significant bleeding disorder Have dermatological or autoimmune conditions that may affect the treatment outcome; these may include, but are not limited to: actinic keratosis, raised nevi, rosacea, melasma, active acne, cutaneous papules/nodules, active inflammatory lesions, dermatitis, psoriasis, cellulitis, urticarial folliculitis, acute inflammatory phase of scleroderma, rheumatoid arthritis, eczema, psoriasis, allergic dermatitis, collagen disorders, or lupus 16 LBL-00029 Rev 011 Have systemic infections or acute local skin infections (as Hepatitis disorders type A, B, C, D, E or F or HIV infection) Take a high dose of anti-coagulants or blood-thinning substances, e.g., aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, heparin, acetylsalicylic acid during the previous fourteen (14) days Are on courses of chemotherapy, high-dose corticosteroid use, or radiation in the treatment area Have undergone plastic surgery of the face within the last twelve (12) months or have any facial surgical scars less than twelve (12) months old Have undergone injections of dermal fillers, fat, or botulinum toxin, as well as any minimally invasive/invasive skin treatment in the treatment area during the previous six (6) months Have scars less than six (6) months old in the treatment area Treatment Precautions Appropriateness for treatment is based on the clinical assessment of the patient by the treating physician. Use caution when treating patients with the following conditions or taking the following medications:

History of hyperpigmentation Recent exposure to sun or tanning History of or active herpes simplex infection in the treatment area beds with red, peeling, or swollen skin Use of topical or oral preparations/medications that may change the skin integrity or prolong healing Over the Counter (OTC) and herbal supplements that may increase the risk of bleeding or prolong healing, such as gingko biloba, garlic, ginseng, dong quai, fever few, and fish oil Recent trauma or surgery to the treatment area Active, chronic, or recurrent infection including bacterial or fungal infections Other medications or medical conditions that may interfere with the treatments or that the treatment provider believes may compromise the safety of the patient or the efficacy of the treatments. Refer the patient to their Primary Care Physician

(PCP) or other managing health care provider for clearance prior to treatment Cytrellis ellacor System with Micro-Coring Technology Operators Manual 17 Side effects should be discussed with the patient prior to treatment. Proper pre- and post-

treatment care reduces the risk of these side effects; however, some conditions may or may not resolve over time. Side effects associated with this procedure may include:

Risks and Benefits Erythema redness Ecchymosis bruising Dryness, roughness Crusting Tenderness Bleeding Numbness Uncommon Side Effects Edema swelling Burning Tightness/Pulling of Skin Pain/Discomfort Tingling Skin Peeling Circular Marks on skin Other side effects not commonly observed with this procedure may include:

Itching Hyper/hypo pigmentation (darkening/lightening of the skin) Hematoma (collection of blood under the skin) Infection Scarring Skin irregularities Skin necrosis (tissue damage) Asymmetrical appearance of the bilaterally treated regions Anesthesia toxicity (anesthesia-related complications may include allergic reaction and possibly death) Benefits In a study of 51 patients with the ellacor System with Micro-Coring Technology, up to three

(3) treatments using density settings of 7% and 8%, depth settings in a range of 2.5mm to 5mm, spaced approximately 30 days apart, showed a significant improvement ( 1 grade change) in moderate to severe cheek wrinkles 90 days after treatment. 18 LBL-00029 Rev 011 Setting up the Treatment Area At the start of each treatment day, verify that the ellacor System is properly set up, as instructed in "System Setup" beginning on page 13, and that the items detailed in the User-

Supplied Items listed below are available. Staging User-Supplied Items Positioning the System Turning on the System Preparing the System for Use Staging User-Supplied Items The following items are supplied by the user. Standard Facility Supplied Items Disposable cosmetic marker or pencils Surgical bonnets and hair bands Dental rolls Tongue depressors Biohazard trash bags Sharps container with a wide mouth that can accept Single-Use Needle Cartridge Small treatment table, mayo stand, or equivalent Small drape for mayo stand Treatment Specific User-Supplied Items These single-use consumables are used once and never used on multiple patients. Vacuum-rated Suction Tubing - inch diameter (6.35 mm), > 6 ft. (1.83 m) Vacuum Filter (5-micron with standard Sterile towels for blood management Soft bristle toothbrush (for cleaning) 70% Isopropyl Alcohol (Isopropanol) connection for 1/4" inch internal diameter suction tubing) Personal protective equipment for provider and assisting staff as per site standard policy Sterile water (chilled) solution and/or wipes Clean wipes (for cleaning and disinfection) Clean Soft Cloth (for cleaning) Gloves Cytrellis ellacor System with Micro-Coring Technology Operators Manual 19 Positioning the System When positioning the ellacor System, make sure the Footswitch can be reached and the Handpiece can be moved freely. Make sure the exhaust vent on the rear of the console is not blocked. Adequate space around the console ensures proper air circulation. 1. Disengage the wheel locks by pulling up on the locking tabs. Figure 9. Locking Tabs Wheel Locked (Tab Down) Wheel Unlocked (Tab Up) 2. Use the Handle on the front of the System Console to push the console to the desired location. WARNING Maintain a separation distance of at least 20 cm (8 in) between the System Console and the body of the user or nearby persons. 3. Engage the wheel locks by pressing down on the locking tabs. Turning on the System Before turning on the system, verify that the system components are properly connected and that the main Power Cable is connected to an appropriate wall power outlet. 4. Press the POWER button on the front of the System Console just below the Touchscreen to turn on the system. NOTE The Power Cable is the main means of power disconnection for the System. 20 LBL-00029 Rev 011 5. When the System has powered up, a Start button appears:

Figure 10. Startup Screen 6. Press the Start button on the Touchscreen. CAUTION Shortly after the Start button is pressed, the handpiece shaft will move. 7. The Handpiece initializes and conducts a self-test. It repositions the mount for the needle hub to the loading position. When the self-test completes, the Patient Profile screen appears:

Figure 11. Patient Profile Screen 21 Cytrellis ellacor System with Micro-Coring Technology Operators Manual 8. Enter the Patient Profile information as appropriate. Once complete, press PROCEED to continue to the Setup screen:

Figure 12. Setup Screen 22 LBL-00029 Rev 011 Preparing the System for Use Setup screen guides the practitioner through the steps for treatment setup, including:

Attaching the Suction Tubing to the Handpiece Cable, Attaching the Suction Tubing to the Vacuum Filter, Attaching the Vacuum Filter to the Console, and Installing and locking the Single-Use Needle Cartridge onto the Handpiece. Attaching the Suction Tubing to the Handpiece Cable 9. Secure the Suction Tubing to the Handpiece Cable using the Tubing Clip. Figure 13. Securing the Suction Tubing to the Handpiece Cable 10. Validate the tubing is secure by pressing the Confirm button to the right of the Clip suction tubing to handpiece label. Cytrellis ellacor System with Micro-Coring Technology Operators Manual 23 Attaching the Suction Tubing to the Vacuum Filter 11. Attach the other end of the Suction Tubing to the Vacuum Filter. Figure 14. Attaching the Suction Tubing to the Vacuum Filter 12. Validate the connection on the Touchscreen by pressing the Confirm button to the right of the Connect suction tubing to filter" label. 24 LBL-00029 Rev 011 Attaching the Vacuum Filter to the Console 13. Attach the Vacuum Filter to the Console. Figure 15. Vacuum Filter Attached to Console 14. Validate the connection on the Touchscreen by pressing the Confirm button to the right of the Connect filter to console label. Figure 16. Setup Screen (Tubing and Filter Installed) Cytrellis ellacor System with Micro-Coring Technology Operators Manual 25 Installing and Locking the Single-Use Needle Cartridge onto the Handpiece 15. Select the appropriate Needle Cartridge:

Figure 17. Single-Use Needle Cartridge CAUTION The System is designed for use only with the Cytrellis Needle Cartridge. 16. Inspect all sterile packaging to ensure that it is not damaged and that the expiration date on the label has not passed. WARNING Discard the Needle Cartridge immediately if the needles have been damaged or suspected of being damaged. 26 LBL-00029 Rev 011 17. While wearing gloves, open the sterile package for the individually wrapped Needle Cartridge and remove the protector from the Needle Cartridge. Figure 18. Removing the Needle Cartridge Protector 18. Unwrap the Handpiece Cord to allow for movement, then remove the Handpiece from the Holster. Insert the Handpiece Head into the Needle Cartridge slot until an audible snap is heard, as shown below:

Figure 19. Inserting the Handpiece into the Needle Cartridge 19. Carefully lift the Handpiece and Needle Cartridge from the packaging, ensuring that the Needle Cartridge is attached to the Handpiece. Cytrellis ellacor System with Micro-Coring Technology Operators Manual 27 20. To ensure the Handpiece is fully inserted into the Needle Cartridge, pull the cartridge towards the Handpiece so that it is flush. There should be no gap between the components. Figure 20. Installing the Needle Cartridge (Flush with the Handpiece) WARNING Follow OSHA guidelines on needle sticks and sharps injury prevention and your office procedures to avoid needle sticks while handling the Needle Cartridge. 28 LBL-00029 Rev 011 21. Once the Needle Cartridge has been fully inserted, lock the Needle Cartridge by pushing the Needle Cartridge Lock into the locked position. When the lock has been fully engaged, the user will hear a single click. Figure 21. Locking/Unlocking the Needle Cartridge on the Handpiece Push to Lock Push to Unlock Needle Cartridge Unlocked Needle Cartridge Locked Figure 22. Zoom in View of Locking Mechanism (Open/Close) Starting/Open Position Ending/Locked Position Needle Cartridge Unlocked (Lock Pushed OUT) Needle Cartridge Locked (Lock Pushed IN) 22. After properly locking the new Needle Cartridge onto the Handpiece, the system automatically changes the Needle Cartridge Status to Completed. 23. Review the Setup Screen to confirm the Needle Cartridge Status says Completed. If the Needle Cartridge Status does not say Completed, try unlocking and relocking the Needle Cartridge to fully engage the Lock. Cytrellis ellacor System with Micro-Coring Technology Operators Manual 29 24. Connect the Needle Cartridge Tubing Connector to the open end of the Suction Tubing. Figure 23. Connecting the Needle Cartridge Tubing to the Suction Tubing 25. Validate the Suction Tubing connection on the Touchscreen by pressing the Confirm button to the right of the Connect needle cartridge tubing label. 26. After all actions on the Setup screen are Completed, press the PROCEED button in the lower right-hand corner to advance to the Treatment screen and select the treatment parameters. Figure 24. Setup Screen (Validation) 30 LBL-00029 Rev 011 27. Set the Handpiece and the other end of the Tubing down on the small treatment table or place in the Handpiece Holster. CAUTION After installing the Needle Cartridge, keep the end of the Distant Spacer free from contact with any surfaces. Do not let the Handpiece fall while completing setup. Take care not to pinch or disrupt the Tubing when positioning the Handpiece. WARNING Discard the Needle Cartridge immediately if the needles have been damaged or is suspected of being damaged. Cytrellis ellacor System with Micro-Coring Technology Operators Manual 31 Treatment Screen The Treatment Screen displays on the Touchscreen after the PROCEED button is pressed on the Setup Screen. Figure 25. Treatment Screen (Standby Mode) Setting From the Treatment Screen, you can:

Toggle between Standby and Ready modes (system status) Select <Skin Removal Percentage> and <Core Depth> setting View the Needle Cartridge type and Total Core Count Complete the treatment session and go to the Treatment Complete screen 32 LBL-00029 Rev 011 Toggling Between Standby and Ready Modes The System status (Standby or Ready) displays on the Treatment Screen at all times to alert you to the current mode. In Standby mode, the Footswitch is disabled and the Vacuum system and Handpiece light are deactivated. In Ready mode, the Footswitch is enabled and the Vacuum system and Handpiece Light are activated. Once the System is in Ready mode, treatment can be initiated by pressing the Footswitch. NOTE When in Ready mode, if the Footswitch is not pressed for five minutes, the System automatically goes into Standby mode. Figure 26. Treatment Screen (Ready Mode) System Status Skin Removal Percentage Total Count Standby/

Ready button Core Depth Setting Vacuum Indicator End Treatment button Cytrellis ellacor System with Micro-Coring Technology Operators Manual 33 Selecting the Skin Removal Percentage and Core Depth Setting Skin Removal Percentage Skin removal percentage is defined as the percentage of tissue removed. See the table for the available <skin removal percentage> settings. NOTE The red dots in the treatment pattern below signify the needle mechanisms starting point as the needles move from left to right to complete the treatment pattern. To select the <skin removal percentage>, press the and + buttons under the Skin Removal display. The corresponding <skin removal percentage> and treatment pattern automatically appears on the treatment screen [see Figure 25. Treatment Screen (Standby Mode)]. Table 3. Skin Removal Percentages by Needle Cartridge Type Triple-Needle Cartridge (10x10 mm window) Skin Removal %

Pattern 1%

3%

5%

7%

8%

34 LBL-00029 Rev 011 Core Depth Setting Core depth setting is defined as the depth of the core removed by the ellacor System with Micro-Coring Technology, measured in millimeters. The core depth may be affected by the quality of the skin being treated. For thin, fragile skin, adjust the <core depth> setting to a lower number (e.g., 3.0); test and evaluate the treatment pattern for efficient coring; and adjust the

<core depth> setting as needed. For thicker, fibrotic skin, adjust the <core depth> setting to a larger number (e.g., 4.0); test and evaluate the treatment pattern for efficient coring; and adjust the <core depth> setting as needed. The <core depth> setting can be set from 0.0 to 4.0, in 0.5 increments. To select the <core depth> setting, press the and + buttons under the Core Depth Setting display. [see Figure 25. Treatment Screen (Standby Mode)]. Viewing the Total Core Count The total number of tissue cores excised for all Needle Cartridges used during the current treatment session is displayed on the Treatment Screen. The Core Count is also displayed on the Treatment Complete screen. Pressing the END TREATMENT button on the Treatment Screen resets the Core Count and deactivates the current Needle Cartridge to prevent cross-

contamination. NOTE Maximum number of cores that can be removed by the Triple-Needle Cartridge is 24,000. Cytrellis ellacor System with Micro-Coring Technology Operators Manual 35 Treatment Instructions Treatment Instructions 1. Ensure that the patient is wearing a hair band or hair net. Clean the patient skin with suitable cleansing wipe to remove all traces of make-up. 2. Using office protocol, determine the appropriate pain management technique. CAUTION A pertinent medical history should be obtained when assessing the risks and benefits of various pain management techniques. Follow the recommended manufacturers instructions for proper use of the desired pain management method. 3. Make the patient comfortable. The patient should be positioned on the treatment bed, with the patients head in a horizontal position. 4. Press the Standby/Ready button on the Treatment Screen to go to Ready mode. CAUTION To prolong needle function, do not apply downward pressure with the treatment window during treatment. Using gauze pads, even those classified as non-shedding, during the procedure may cause the Needle Cartridge to clog. Use sterile towels for blood management instead. 5. Select the appropriate <skin removal percentage> and <core depth> setting, as described in the previous section, to deliver the best treatment for the patient. Please see schematic below for recommended starting <core depth> settings. The

<core depth> setting can be increased or decreased by 0.5mm increments to achieve maximum coring and ensure patient safety. 6. To ensure patient safety, consider the dermal and subcutaneous fat thickness of the patient as well as location of nerves and blood vessels when selecting the coring depth setting. Refer to the schematic below of front and side views of the face including nerves, blood vessels and anatomical areas as well as core depth setting guidance. Descriptive explanations are also provided. Do NOT apply downward pressure on the handpiece during treatment to avoid compressing the tissue. 36 LBL-00029 Rev 011 Yellow looks like the cheek bone; start at 3.0mm not 3.5mm Cytrellis ellacor System with Micro-Coring Technology Operators Manual 37 Move down the yellow cheek treatment starts up too high on face; change starting depth to 3.0mm 38 LBL-00029 Rev 011 Trigeminal nerve branches The Supraorbital Nerve is located on average 25.32mm from the facial midline at the medial brow The Infraorbital Nerve is located on average 29.57mm from the facial midline. The distance from the infraorbital rim is on average 8.8mm. The Mental Nerve is located 25.55mm from the facial midline. The mental foramen is located between the first and second premolar, or at the second premolar. Facial nerve branches The Frontal Nerve is located is located along Pitanguy's Line, which is defined as running from 0.5 cm below the tragus to 1.5 cm above the lateral eyebrow. The mean horizontal distance of the zygomatic branch as it emerged from the anterior border of the parotid gland and the tragus is 30.71 mm, whereas the mean vertical distance of the zygomatic branch from the midpoint between the tragus and the lateral palpebral commissure is 19.29 mm. The Buccal Nerves course below a line drawn from tragus to ala nasi. In proximity to the treatment area, the Marginal Mandibular Nerve the runs, on average, 3.6 mm superior to the point at which the facial artery reaches the inferior border of the mandible, and 10.9 mm superior to the vertical line that extends from the commissure of lip to the inferior border of the mandible. Arteries The Facial Artery is located is located 19 mm 5.5 from the oral commissure, 31 mm 6.8 from the mandibular angle, 92 mm 8.0 from the lateral canthus. The Angular artery runs along the nasolabial fold 6.7 4.4 mm from the nasal Superficial temporal artery is located 16.68+/-0.35 mm at the front of the ala. tragus. Cytrellis ellacor System with Micro-Coring Technology Operators Manual 39 7. Hold the skin taut and place the Needle Cartridge on the area of the skin to be treated. 8. When the Needle Cartridge is correctly placed on the skin, the suction air flow is no longer audible at the treatment window, be careful not to break the suction. Use this technique to ensure optimal skin surface interaction with the needles. Do NOT apply downward pressure while needles are moving to prevent damage to the needles. NOTE Retract/stretch loose skin if necessary, taking care to keep fingers out of the treatment window area. Suction may be difficult to achieve on smaller and bony areas. In these areas, position the window on the skin and activate the Footswitch, but do NOT apply downward pressure. CAUTION Verify that the treatment parameters are correct before pressing the Footswitch. 9. Press and hold the Footswitch down to deliver the treatment pattern. The treatment will be applied according to the <skin removal percentage> selected. The pattern will be applied starting in the current location of the needles. WARNING Keep hands and fingers away from the treatment window at all times while the needle is activated. Do NOT continue use of the System if the power goes out. If the System experiences a sudden loss of power, the needles may remain extended beyond the distance spacer. Take precautions against needle sticks. Avoid coming in contact with the treatment area of the distance spacer when the Handpiece is unpowered. NOTE To terminate treatment without powering down the system, simply release the Footswitch. 10. When the ellacor System has completed the treatment pattern, the Vacuum will disengage, and the needles will stop moving. Lift the Needle Cartridge from the skin and assess the cored area. The cored area should be visually distinct (with lines/edges indicating where the treatment had been applied) and a clean center with no evident debris. 11. If coring was not achieved, review the treatment settings and technique. Increase the <core depth> setting or hold the skin tauter around the treatment area and repeat the pattern. 40 LBL-00029 Rev 011 12. Repeat steps 5 through 9 until the desired level of coring is achieved. To remove blood and maintain visibility of the treatment area, use a sterile towel dampened in chilled sterile water. 13. Move onto the adjacent area to be cored. Hold the skin taut, place the Needle Cartridge on the area of the skin to be treated, gently pull up on the Handpiece being careful not to break the suction, and then press the Footswitch to deliver the coring pattern. Repeat this step for each area to be cored until the entire treatment area has been cored. (Visualize one row/column of cores across the treatment area to provide a well-aligned treatment pattern.) NOTE To interrupt treatment at any time, simply release the Footswitch. The system remains in Ready mode unless you press the Standby/Ready button to go to Standby mode. To continue treatment from Ready mode, press the Footswitch. To continue treatment from Standby mode, press the Standby/Ready button to Ready mode, and then press the Footswitch. 14. After all areas have been treated, wipe the face with chilled sterile water and sterile towel to remove any debris. Apply a light film of petrolatum to the treatment area. 15. Instruct patient on post care treatment and possible side effects:

a. Cleanse the treated area twice daily with water and mild facial cleanser. Do not scrub or vigorously rub face b. Apply light film of petrolatum at least twice daily for 7 days c. After skin has healed (no open wounds and holes have closed), apply a broad-spectrum sunscreen daily and refrain from direct sun exposure d. Refrain from the following activities until skin is fully healed (no open wounds and holes have closed):

i. Shaving ii. Using tanning beds and sunless tanning cream iii. Direct sun exposure iv. Scrubbing, scratching and/or picking at the treated area v. Contact sports or any other activity that could cause injury to the treated area rivers vi. Submerging the treated area in pools, whirlpools, lakes, oceans or vii. Activities that result in overheating, such as long exposure to hot baths, spas, or excessive exercise 16. After completing the treatment session, press the END TREATMENT button on the Treatment Screen. Cytrellis ellacor System with Micro-Coring Technology Operators Manual 41 42 17. When the validation screen appears, choose one of the following:

Press the END TREATMENT button to go to the Treatment Complete Screen. Press the CANCEL - RETURN button to return to the previous screen. Figure 27. End Treatment Validation Screen Figure 28. Treatment Complete Screen LBL-00029 Rev 011 Replacing the Needle Cartridge During Treatment 18. Press the Standby/Ready button to go to Standby mode. CAUTION The Needle Cartridge can only be removed from the Handpiece when the system is in Standby mode. If you attempt to unlock the Needle Cartridge when the system is in Ready mode, a notification pop-up window displays on the Touchscreen to alert you to re-lock the Needle Cartridge. After re-locking the Needle Cartridge, the system goes to Standby mode, enabling you to remove the Needle Cartridge. 19. Disconnect the Suction Tubing from the Needle Cartridge Tubing Connector and place the Tubing onto your work area. 20. Remove and dispose of the Needle Cartridge, as instructed in Post-Treatment Clean-up Instruction on page 44. 21. Install the new Needle Cartridge, as instructed in Installing and Locking the Single-

Use Needle Cartridge onto the Handpiece on page 26. 22. Reconnect the Suction Tubing to the Needle Cartridge Tubing Connector. 23. Verify that the new Needle Cartridge is properly installed by confirming the status on the Setup Screen, then press the Proceed button to go to the Treatment Screen. WARNING Discard the Needle Cartridge immediately if the needles have been damaged or is suspected of being damaged. 24. Resume the treatment session. Cytrellis ellacor System with Micro-Coring Technology Operators Manual 43 Post-treatment Clean-up Instructions After completing the treatment session and pressing the End Treatment button on the Treatment Screen, the Treatment Complete screen displays. The Treatment Complete screen guides you through the steps for removing the single-use treatment components, as described below. Figure 29. Example Treatment Complete Screen 1. Disconnect the Needle Cartridge Connector from the Suction Tubing. 44 LBL-00029 Rev 011 2. Push the Needle Cartridge Locking Tab to the unlock position. Figure 30. Push Out Locking Tab 3. Pull the Needle Cartridge straight off the end of the Handpiece. Use a quick and firm motion to avoid damaging the Handpiece. WARNING Follow OSHA guidelines on needle sticks and sharps injury prevention and your office procedures to avoid needle sticks while handling the Needle Cartridge. Figure 31. Pull Needle Cartridge Off Handpiece 4. Dispose of the Needle Cartridge in a wide mouth sharps container and per facility protocol. 5. Disconnect the Suction Tubing from the Tubing Clip. 6. Disconnect the Vacuum Filter from the System Console and dispose of the Suction Tubing and Vacuum Filter in a biohazard bin per facility protocol. Cytrellis ellacor System with Micro-Coring Technology Operators Manual 45 Treatment Clean-Up". Post-Treatment Clean-Up 7. Proceed to clean and disinfect the Handpiece as instructed below in "Post-

Disconnect the Handpiece from the System Console prior to completing the cleaning and disinfection steps. Table 4. Routine User Maintenance Activities Action Frequency Clean the Handpiece Disinfect the Handpiece Between patient use Between patient use Clean the System Console (including the display, holster, and any contaminated surfaces) As needed Cleaning the Handpiece These steps remove any debris, soil or bodily fluids which may be present on the handpiece prior to disinfection. A toothbrush dampened with warm tap water and 70% isopropyl alcohol wipes are needed to complete these steps. WARNING Perform all cleaning and disinfection steps in an appropriate room separate from the patient. Personal protective equipment (PPE) must be worn by personnel performing the reprocessing. 46 LBL-00029 Rev 011 8. Immediately after use, install the Handpiece Cleaning Cover onto the front of the Handpiece as shown. NOTE The Handpiece Cleaning Cover is intended to prevent water ingress during cleaning. Figure 32. Installing the Handpiece Cleaning Cover Handpiece without Cleaning Cover Handpiece with Cleaning Cover Installed 9. Thoroughly clean the Handpiece surface using a soft bristled Toothbrush. Wet the Toothbrush with warm tap water. Shake off the excess water. Gently brush the outer surfaces of the Handpiece, paying particular attention to the crevices and seams of the Handpiece shell. See diagram in Figure 33 for surfaces requiring cleaning with the soft bristled toothbrush. CAUTION Do NOT submerge in water or autoclave the Handpiece. Do NOT use the wet brush on the Handpiece Actuator Cytrellis ellacor System with Micro-Coring Technology Operators Manual 47 10. Dampen a clean wipe with warm tap water, and thoroughly wipe the Handpiece Actuator for at least 30 seconds. Discard the wipe. Repeat this step until all visible soil is removed. CAUTION Ensure that the wipe is damp, not wet. Figure 33. Handpiece Surfaces to be Cleaned Red arrows indicate surfaces that require brushing per step 2, green arrow indicates the Handpiece Actuator surface to wipe per step 3. 11. Dampen a clean wipe with warm tap water, and thoroughly wipe all surfaces of the Handpiece for at least 30 seconds. Discard the wipe. CAUTION Ensure that the wipe is damp, not wet. 12. With an unaided eye, visually examine the surface to ensure that all adherent soil has been removed. Repeat the cleaning process if necessary. 13. Dampen another clean wipe with 70% isopropyl alcohol (isopropanol), and thoroughly wipe all surfaces of the Handpiece for at least 30 seconds. 14. Allow the Handpiece to dry completely before disinfection by either air-drying or drying with a sterile lint-free tissue. 48 LBL-00029 Rev 011 Disinfecting the Handpiece These steps significantly reduce any remaining bacterial and vegetative organisms not removed during the cleaning procedure. Multiple 70% isopropyl alcohol wipes are needed to complete these steps. 15. After cleaning the Handpiece, wipe the Handpiece with a clean wipe dampened with 70% isopropyl alcohol (isopropanol). Discard the wipe. 16. Dampen another clean wipe with 70% isopropyl alcohol (isopropanol) and wipe the Handpiece thoroughly for five (5) minutes. 17. Follow this cleaning with an additional eight (8) minutes of continuous contact of the wipe with the surfaces being cleaned. Additional wipes should be used as needed to ensure the Handpiece is continuously contacted with a wet 70% isopropyl alcohol (isopropanol) wipe. 18. Allow Handpiece to dry completely before use by either air-drying or drying with a sterile lint-free tissue. 19. Remove and dispose of Cleaning Cover. NOTE The Handpiece Cleaning Cover is a single-use component and intended to be discarded after disinfection. Cytrellis ellacor System with Micro-Coring Technology Operators Manual 49 Cleaning the System Console Wipe the external surfaces of the System Console for at least 30 seconds with a clean wipe dampened with 70% isopropyl alcohol (isopropanol). Dry with a clean cloth or allow to air dry. WARNING Do NOT attempt to gain access to any internal components, electrical shock may result. CAUTION Do not spray or pour cleaning agents directly onto the System Console, as damage may occur. Cleaning the Touchscreen Display Apply an alcohol-based cleaner to a soft cloth and wipe the Touchscreen display for at least 30 seconds. Allow to air dry. CAUTION Do not spray or pour cleaning agents directly onto the Touchscreen, as damage may occur. 50 LBL-00029 Rev 011 Turning Off the System Users can turn the system off using the physical POWER button on the front of the Console or the POWER OFF button on the Treatment Complete screen. 20. To turn the system off, choose one of the following:

Press the physical POWER button on the front of the System Console. Press the POWER OFF button on the Treatment Complete screen. If the Touchscreen becomes nonresponsive, press and hold the physical POWER button on the front of the System Console. The treatment is terminated (if in progress) by pressing the POWER OFF button on the Touchscreen. CAUTION When the Power Cable is connected to the wall outlet, some internal circuits remain energized. To de-energize all internal circuits, unplug the Power Cable from the wall outlet. Figure 34. Power Off Screen 21. When the validation screen appears, choose one of the following:

Press the YES - POWER OFF button to turn off the system. Press the NO - RETURN button to return to the previous screen. Cytrellis ellacor System with Micro-Coring Technology Operators Manual 51 Figure 35. Power Off Validation Screen 52 LBL-00029 Rev 011 Disconnecting the System Components 22. Verify that the System is turned off, as described in the previous section. 23. Place the Handpiece in the Holster and wrap the Handpiece Cable on the Handpiece Cable Hanger. Figure 36. Handpiece in Holster; Cable on Cable Hanger 24. Disconnect the Power Cable plug from the electrical outlet and wrap the Power Cable around the Cable Wrap on the rear of the System Console. 25. Disconnect the Footswitch Cable, place the cable inside the Footswitch housing or on the Power Cable Wrap on the back of the system, and store the Footswitch on the Footswitch Mount on the rear of the System Console. Figure 37. Footswitch Mount Before View After View Cytrellis ellacor System with Micro-Coring Technology Operators Manual 53 Moving the System 26. Disconnect the System components (See Disconnecting the System Components above). 27. Disengage the Wheel Locks by pulling up on the Locking Tabs. 28. Use the Handle on the front of the System Console to push the Console to the desired location. 29. Engage the Wheel Locks by pressing down on the Locking Tabs. 54 LBL-00029 Rev 011 Maintenance System Maintenance Replacing the Fuses The ellacor System with Micro-Coring Technology requires regular maintenance to provide optimal performance. Annual system maintenance by trained Cytrellis personnel is required to maintain the warranty. The ellacor System uses two 5x20mm, 10 A, 250 VAC fuses. (Type: CER, Slow; Breaking Capacity: 1.5kA). If attempts to activate the Power Button on the front of the System Console do not illuminate the Touchscreen or the Power Button, ensure that the console is properly connected to AC power (plugged in). If the console is connected to AC power, then the fuses may need to be replaced, as follows:

1. Disconnect the Power Cable plug from the electrical outlet and remove the Power Cable from the main power receptacle on the rear of the System Console. 2. Locate the Fuse Holder above the main Power Receptacle. Figure 38. System Console Fuse Holder Fuse Location (Back of Console) Fuse Holder 3. Insert a flathead screwdriver into the notch at the bottom of the Fuse Holder and gently pry open the Fuse Holder. 4. Pull the Fuse Holder out. 5. Remove the old Fuses and replace with new ones. 6. Reinsert the Fuse Holder, ensuring that the notch is at the bottom. 7. Press down on the Fuse Holder until the holder snaps into place. Cytrellis ellacor System with Micro-Coring Technology Operators Manual 55 Appendix A System Specifications Table 5. System Specifications Physical Characteristics Needle type Needle geometry Needle length Maximum penetration depth Needle depth tolerance Maximum puncture rate System console weight System console size (H x W x D) Power cable length Handpiece weight Handpiece size (H x W x D) Handpiece cable length Footswitch weight Footswitch size (H x W x D) Footswitch cable length Max. vacuum pressure Cartridge box size (H x W x D) Electrical Requirements 22 Gauge hypodermic coring needle, type 304 stainless steel Ground to 10 tip angle resulting in 2 cutting surfaces and 2 tips 6.0 mm 5.0 mm (corresponds to 4.0 mm core depth setting) 0.5 mm 12 Hz 42 kg (92.6 lb) 45.7 cm x 45.7 cm x 106.7 cm (18 in x 18 in x 42 in) 1.83 m (6 ft) 550 g (1.2 lb) 20.3 cm x 21.6 cm x 6.4 cm (8 in x 8 1/2 in x 2 1/2 in) 2 m (6 ft 6 in) 1.2 kg (2.6 lb) 12.0 cm x 15.0 cm x 14.2 cm (4 3/4 in x 5 15/16 in x 5 9/16 in) 2.67 m (8 ft 9 in) 100 kPa 8.8cm x 26.5cm x 16.7cm (3 7/16 in x 10 7/16 in x 6 9/16 in)

~100-240 VAC Voltage 50-60 Hz Frequency Current 8.5 A Environmental Requirements (Operating) 2,000 m (6562 ft) 15 C - 30 C (59 F - 86 F) 20% - 80% non-condensing 70 kPa - 106 kPa Maximum altitude Temperature range Maximum humidity Atmospheric Pressure Environmental Requirements (Non-operating) Maximum altitude Temperature range Maximum humidity Atmospheric Pressure Classifications Standard commercial shipping altitude 5 C - 40 C (41 F - 104 F) 10% - 90% non-condensing 70 kPa - 106 kPa Type Degree Applied part IPX rating Class I ME Equipment Type B Handpiece Single-Use Needle Cartridge System console: IP32 Handpiece (with Single-Use Needle Cartridge installed): IP22 56 LBL-00029 Rev 011 Appendix B Safety and Regulatory Compliance General Safety and Regulatory Information The ellacor System with Micro-CoringTM Technology is a precision medical instrument. The System has undergone extensive testing. To protect operating personnel and patients, this manual should be read thoroughly and understood before operation. Cytrellis does not make recommendations regarding the practice of medicine. Treatment parameters are provided as a guide. Individual treatments should be based on clinical training and clinical observation of appropriate clinical endpoints. Electrical Hazards Table 6. Electrical Hazards Symbol Definition Do NOT attempt to perform maintenance other than that which is outlined in this Do NOT attempt to gain access to any internal components, as electrical shock Maintenance should only be performed when the system is turned off and disconnected from the power source. To avoid risk of electric shock, this equipment must only be connected to a supply main with protective earth. Only an authorized Cytrellis service representative should perform service on the The system is grounded through the grounding conductor in the power cord. Grounding is essential for safe operation. WARNING manual. may result. CAUTION system. Cytrellis ellacor System with Micro-Coring Technology Operators Manual 57 Additional Safety Considerations Table 7. Additional Safety Considerations Symbol Definition WARNING CAUTION During a power loss, the needles may remain extended beyond the distance spacer. Take precautions against needle sticks. Avoid contacting the treatment area of the distance spacer when the Handpiece is unpowered. Do NOT re-use single-use parts (Needle Cartridge, Suction Tubing, or Vacuum Do NOT store the Needle Cartridge boxes in direct sunlight. UV lights can cause Filter) for multiple patients. damage to the sterile packaging. Follow OSHA guidelines on needle sticks and sharps injury prevention and your office procedures to avoid needle sticks while handling the Needle Cartridge. Keep hands and fingers away from the Handpiece and Needle Cartridge to avoid moving parts hazards. Do NOT locate System so that it is difficult to access power supply cord. No modification of the System is allowed. Do NOT use any other manufacturers Needle Cartridge with the System. It is designed for use with the Cytrellis Needle Cartridges only. Do NOT submerge in water or autoclave the Handpiece. Do NOT spray or pour cleaning agents directly onto the System Console or Touchscreen, as damage may occur. No untrained or unqualified personnel shall use the System at any time. The System is intended solely for licensed practitioners trained in its proper use. The Handpiece is a fragile instrument and must not be dropped. If a Handpiece is dropped, carefully examine the Handpiece for any physical damage prior to use. Verify that the treatment parameters are correct before pressing the Footswitch. Use the Potential Equalization Conductor to bring other equipment to the same case potential as the System. NOTE To prolong needle function, do NOT apply downward pressure with the treatment window when coring. 58 LBL-00029 Rev 011 Regulatory Compliance Safety Features Needle Penetration Hard-stop The proprietary Micro-Coring Technology is designed to provide needle penetration depth control for a core depth setting from 0.0 to 4.0 mm. In addition, the ellacorTM System has an emergency mechanical stop to prevent the needle tips from extending more than 6.75 mm (1/4 in) beyond the end of the Distance Spacer. Electrical Fault Detection Circuitry If the System detects a fault condition, an error message displays on the Touchscreen and the system enters a safe state. Some fault conditions are user-clearable. Refer to Error Codes, Messages & Troubleshooting for additional information. Location and Definition of Regulatory and Other System Labels As required by national and international regulatory agencies, appropriate regulatory compliance labels have been mounted in the locations specified in the Label Symbols section on the following page. All treatment room staff should be familiar with the location and meaning of these labels. Cytrellis ellacor System with Micro-Coring Technology Operators Manual 59 Label Symbols Table 8. Label Symbols Symbol Standard Reference Description Location BS EN ISO 15223-1 Catalogue number BS EN ISO 15223-1 Batch Code BS EN ISO 15223-1 Serial number BS EN ISO 15223-1 Date of manufacture BS EN ISO 15223-1 Manufacturer Console, Handpiece, and Single-Use Needle Cartridge labels Console, Handpiece, and Single-Use Needle Cartridge labels Console and Handpiece labels Console and Handpiece labels Console, Handpiece and Single-Use Needle Cartridge labels IEC 60601-1 Refer to Operators Manual Console, Footswitch, and Handpiece labels BS EN ISO 15223-1 Caution Console, Footswitch and Handpiece labels IEC 60601-1 Type B applied part Handpiece labels 21 CFR 801.109 US federal law restricts this device to sale by or on the order of a practitioner licensed by the law of the state in which he/she practices using or order the use of the device. Console, Footswitch, Handpiece, and Single-

Use Needle Cartridge labels 60 LBL-00029 Rev 011 Table 9. Label Symbols Symbol Standard Reference Description Location BS EN ISO 15223-1 Use-by Date BS EN ISO 15223-1 Do not reuse Single-Use Needle Cartridge label Single-Use Needle Cartridge label BS EN ISO 15223-1 Sterilized using irradiation Single-Use Needle Cartridge label IEC 60601-1 Equipotentiality Console IEC 60601-1 Protective earth

(ground) Console BS EN ISO 15223-1 Consult instructions for use Single-Use Needle Cartridge label BS EN ISO 15223-1 Keep away from sunlight Single-Use Needle Cartridge label BS EN ISO 15223-1 Humidity limitation Single-Use Needle Cartridge label BS EN ISO 15223-1 Temperature limitation Single-Use Needle Cartridge label BS EN ISO 15223-1 Atmospheric pressure limitation Single-Use Needle Cartridge label ASTM F2503-20 Console label Known to pose hazards in all MR environments Cytrellis ellacor System with Micro-Coring Technology Operators Manual 61 FCC Information NFC Device FCC ID: 2AUPV-830-00013 Model: 830-00013 Contains Cellular Module:

FCC ID: XPY2AGQN4NNN Model: MTQN-MNG1-B02.R1 (SARA-R410M) (Manufactured by Multi-Tech Systems, Inc.) This device complies with Part 15 of the FCC Rules. Operation is subject to the following conditions:

1. This device may not cause harmful interference, and 2. This device must accept any interference received, including interference that may cause undesired operation. Changes and Modifications not expressly approved by Cytrellis can void your authority to operate this equipment under Federal Communications Commissions rules. User Steps to Access FCC Electronic Labeling 1. From the Startup Screen, press the information icon in the bottom left corner. Figure 39. Startup Screen 62 LBL-00029 Rev 011 2. The FCC Electronic Label is shown on the left side of the screen. Figure 40. System Information Screen Cytrellis ellacor System with Micro-Coring Technology Operators Manual 63 Wireless Technologies WARNING Other equipment could interfere with the communication of this device, even if the other equipment complies with CISPR8 emission requirements. Near Field Communication (NFC) Device The ellacor System with Micro-Coring Technology is equipped with an NFC tag reader for interfacing with the Cytrellis Needle Cartridge. This feature allows the system to ensure that Needle Cartridges are compatible with the system. Needle Cartridge configuration data is read from the Needle Cartridge when it is loaded onto the Handpiece. After use, the Needle Cartridge is automatically disabled by the system to prevent reuse of the cartridge. All data is encrypted to ensure its integrity. The NFC device meets the requirements of ETSI EN 300 330 V2.1.1 (2017-02) - Short Range Devices (SRD); Radio Equipment in the Frequency Range 9 kHz to 25 MHz and Inductive Loop Systems in the Frequency Range 9 kHz to 30 MHz; Harmonized Standard Covering the Essential Requirements of Article 3.2 of Directive 2014/53/EU.NFC applications must fall entirely within the frequency bands for short range devices from 9 kHz to 30 MHz. The NFC device utilized within the System is designed to operate at 13.56 MHz at an estimated power of less than 500 nanowatts within the range of 8mm or less. The targeted location for relevant operation is fixed by the Needle Cartridge and its installation onto the Handpiece. Distances greater than 8 mm do not provide enough energy to operate the NFC tag in the Needle Cartridge. Quality of service does not apply for the operation of the NFC device. NFC functions and commands are designed specifically to operate with selected Cytrellis NFC tags that have been properly formatted. Data is loaded and stored on command and integrity is confirmed through error statuses, fault codes, cyclic redundancy checks, and AES encryption within the device and within the system. Operation of the NFC device only occurs when requested by a triggering event. When the System is running a treatment pattern, the NFC device is turned off. While the NFC device is designed and configured to read and verify a single NFC tag at a time, care should be taken to ensure that limited RF devices are operating in close proximity to the handpiece during use. Other transmitters may interfere with NFC operation. WARNING Other equipment with RF emitters including RFID readers could interfere with the operation of this device. To prevent interference, ensure that other such equipment is not operated within 30 cm of the ellacor System with Micro-Coring Technology. 64 LBL-00029 Rev 011 Any errors triggered due to interference with the NFC should result in an Error 201 or 202 on the System Screen. Refer to the Troubleshooting Guidance in Appendix C for details on how to proceed if an error occurs. Wireless and Cellular Module The ellacor System with Micro-Coring Technology is also equipped with cellular communication capabilities. This allows performance data to be wirelessly transmitted to Cytrellis in a secure fashion for the purposes of ensuring optimal system operation, monitoring for potential service issues, and helping you better utilize your system. Data stored by the System relates to each procedure including parameter settings, core counts, error codes, and performance data. No patient-identifying data is used, stored, or transmitted by the system. Any data transmitted from the system is done utilizing encrypted connections to a secure server accessible only to authorized Cytrellis personnel. Data transmission is done via secure cellular communications and does not require WiFi or other network connection configured at the installation site. Data transmission happens automatically without the need for the operator to enable this feature. Data from a completed procedure is stored prior to System shutdown. In order to ensure that your data is properly stored, do not unplug the system until it has completely powered down. Stored data will be transmitted the next time that the System powers up. Once transmission of data is complete the System powers down the module to a standby mode. A failure to connect to the wireless network will timeout and allow the System to startup normally. Other transmitters operating in the vicinity of the System during data transmission may prevent data from being properly transmitted. Wireless communication depends on cellular network availability. Coverage may not be available everywhere and varies by network coverage and service levels. Please be aware that within the cellular network, the availability and quality of the service may be affected by terrain, buildings, and the weather. Data might not be transmitted if the system is used outside of the country or region of purchase. Coverage is not required for the system to operate safely and effectively. The cellular module meets requirements of IEC60601-1-2 and FCC Part 15 Class B. Cytrellis ellacor System with Micro-Coring Technology Operators Manual 65 The cellular module may utilize the AT&T network for 4G LTE frequency and bands as noted:

Table 10. AT&T Operating Frequencies & Bands Frequency (MHz) 700 Bands Band 12,13,29 850 1700/2100 1900 2600 Band 5 Band 4 Band 2 Band 30 Frequency (MHz) 700 1700/2100 1900 Bands Band 13 Band 4 Band 2 The cellular module may utilize the Verizon Wireless network for 4G LTE frequency and bands as noted:

Table 11. Verizon Operating Frequencies & Bands 66 LBL-00029 Rev 011 Electromagnetic Compatibility The ellacorSystem with Micro-CoringTechnology design complies with IEC 60601-1-2 (Edition 4.0) requirements for electromagnetic compatibility (EMC) with other devices. Like other electrical medical equipment, the System requires special precautions to ensure EMC with other electrical medical devices and must be installed and operated according to the EMC information provided in this manual. Consult the tables on the following pages for guidance in placing the System. WARNING Do NOT use cables or accessories other than those provided with the System, as this may result in increased electromagnetic emissions or decreased immunity to such emissions. Do NOT use the System adjacent to or stacked with other equipment, before verifying normal operations under the configuration in which it will be used prior to use. Portable and mobile RF communications equipment

(including peripherals such as antenna cables and external cables) should be used no closer than 30 cm (12 inches) to any part of the System, including cables specified by the manufacturer. Otherwise, degradation in the performance of this equipment could result. The following table describes the basic safety and essential performance specifications defined for the System. The right-most column includes the error condition that the operator would expect to see due to any potential, unforeseen electromagnetic disturbances that result in the loss or degradation of the corresponding specification. Refer to the Troubleshooting Guidance in Appendix C for details on operator actions in response to the error condition created. Table 12. Basic Safety and Essential Performance for the System Basic Safety and Essential Performance Characteristic Specification Possible Error Condition(s) Z Position: Core depth determined by the distance the needle extends away from the handheld X Position: Core position within the spacer flange in the side-to-side direction No greater than 6.75 mm tip depth The maximum needle penetration depth is not affected, lost, or degraded by EM disturbances. No greater than 0.5 mm deeper than the chosen set point Handpiece will stop and a system Error 64 will appear. No overlapping holes Handpiece will stop and a system Error 2 or 10 will appear. Cytrellis ellacor System with Micro-Coring Technology Operators Manual 67

(perpendicular to the handle) Y Position: Core position within the spacer flange in the side-to-side direction

(parallel to the handle) Vacuum Pressure: Amount of pressure at the spacer flange applied by the vacuum Consumable Configuration:

Data on RFID tag, which communicates needle position, manufacturing date, and whether the consumable has been used. Basic Safety and Essential Performance No overlapping holes Handpiece will stop and a system Error 4 or 12 will appear. Vacuum control is within 20% of expected pressure Vacuum pressure outside of expected range will result in a vacuum notification on the screen as well as reduced suction on the distance spacer treatment window. No undetected read or write errors. System will prevent start of treatment and a system Error 201, 202, 204, or 206 will appear. Table 13. Guidance and Manufacturer's Declaration: Electromagnetic Emissions Guidance and Manufacturers Declaration: Electromagnetic Emissions The ellacor System with Micro-Coring Technology is intended for use in the electromagnetic environment specified below. The customer or the user of the System should ensure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment: Guidance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage Fluctuations/flicker emissions IEC 61000-3-3 Group 1 Class B Group 1 Class B Complies Complies The System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The System is suitable for use in professional healthcare and clinical environments. The System is not intended to be used in the operating room (i.e., near electrosurgical equipment) or in the shield room of MRI equipment. Warning: This equipment/system is intended for use by healthcare professionals only. This equipment/system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the System or shielding the location. 68 LBL-00029 Rev 011 Table 14. Electromagnetic Immunity Guidance and Manufacturers Declaration: Electromagnetic Immunity The ellacor System with Micro-Coring Technology is intended for use in the electromagnetic environment specified below. The customer or the user of the System should ensure that it is used in such environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment:

Guidance. Electrostatic Discharge (ESD) IEC 61000-4-2 8kV contact 8kV contact 15kV air 15kV air Electrical fast transient/burst IEC 61000-4-4 2kVAC lines 2kV AC lines 1kV I/O lines 1kV I/O lines Surge IEC 61000-4-5 1kV line to line 1kV line to line 2kV line to P.E. 2kV line to P.E. Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11 0% UT .5 cycle 0% UT .5 cycle 0% UT 1 cycle 0% UT 1 cycle 70% UT 25 cycles 0% UT 250 cycles 70% UT 25 cycles 0% UT 250 cycles Power frequency

(50/60 Hz) magnetic field IEC 61000-4-8 RFID magnetic field immunity IEC 61000-4-39 30 A/m 65 A/m 7.5 A/m 30 A/m 134.2 kHz @

2.1kHz PM 13.56 MHz @

50 kHz PM NOTE: UT is the AC mains voltage prior to application of the test level. Floor should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30-60%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the Dermal Micro-Coring System requires continued operation during power mains interruptions, it is recommended that the Dermal Micro-Coring System be powered from an uninterruptible power supply or a battery. Power-frequency magnetic fields should be at levels characteristics of a typical location in a typical commercial or hospital environment. Cytrellis ellacor System with Micro-Coring Technology Operators Manual 69 Table 15. Electromagnetic Immunity (Contd) Guidance and Manufacturers Declaration: Electromagnetic Immunity The ellacor System with Micro-Coring Technology is intended for use in the electromagnetic environment specified below. The customer or the user of the System should ensure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Conducted RF 0.15 - 80 MHz 0.15 - 80 MHz IEC 61000-4-6 3 Vrms & 6 Vrms in 3 Vrms & 6 Vrms in ISM bands 80%

ISM bands 80%

AM modulation @

AM modulation @

1 kHz AC Mains 1 kHz AC Mains Radiated RF 80 MHz - 2.7 GHz 80 MHz - 2.7 GHz IEC 61000-4-3 3 V/m 80% @ 1 kHz 3 V/m 80% @ 1 kHz d = 1.17 P Proximity field Spot frequencies Spot frequencies from RF wireless 385MHz 5.750 GHz 385MHz 5.750 communications Pulse Modulation GHz Pulse Modulation equipment IEC 61000-4-3 10 V/m, PM @ 217 3100 MHz to 4990 Hz MHz Electromagnetic Environment:

Guidance Portable and mobile RF communications equipment should be used no closer to any part of the System, including its cables, then the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended Separation Distance d = 1.17 P 80MHz to 800MHz d = 2.33 P 800MHz to 2.5GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths 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 marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobiles radios, amateur radio, AM and FM radio broadcast, and TV broadcast, cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ellacor System with Micro-Coring Technology is used exceeds the applicable RF compliance level above, the ellacor System with Micro-Coring Technology should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the System. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m. 70 LBL-00029 Rev 011 Table 16. Separation Guidance from Portable and Mobile RF Communications Equipment Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the ellacor System with Micro-Coring Technology The ellacor System with Micro-Coring Technology is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the System as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power (W) of 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 0.1 1 10 100 0.12 0.37 1.17 3.70 11.70 0.12 0.37 1.17 3.70 11.70 0.23 0.74 2.33 7.37 23.30 For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Cytrellis ellacor System with Micro-Coring Technology Operators Manual 71 Clinical Summary A clinical study was conducted to support the safety and effectiveness of the ellacor System with Micro-Coring Technology for the treatment of moderate to severe cheek wrinkles in adults aged 22 years or older with Fitzpatrick skin types I-IV. The objective of the study was to assess the effectiveness of the proposed device in reducing the signs of skin aging as measured by the improvement in wrinkles after at least two (2), but no more than three (3) standardized treatment sessions and to assess the safety of the proposed device as measured by the number of adverse events. The multicenter study was conducted at four (4) sites in the United States. Subjects were treated at least two (2) times, but no more than (3) times, approximately 30 days apart, with the final assessment 90 days after the last treatment. Professional clinical portrait photographs were taken of the subject at Day 0, Day 30, Day 60 and Day 90. Day 30, Day 60 and Day 90 photos were taken for each treatment.*

Treatments were performed by licensed medical professionals. Prior to treatment the subject was injected with local anesthetic, per the sites procedure(s). A Triple Needle Cartridge and densities of 6.7% and 7.9% (percent of skin removed per 1 cm2) were used. The operator started the treatment at a core-depth setting of 3 mm but could increase or decrease the core-depth setting in increments of 0.5 mm for a range of 2.5 to 5 mm to achieve maximum coring and ensure subject safety. Following the treatment, Aquaphor was applied to the treated areas. Demographics:

Fifty-one (51) subjects completed the study. The average age of the subjects was 62.9 years. The subject population was predominantly female (98%). The study included subjects with Fitzpatrick skin types I to IV. Effectiveness Physician Reported Outcomes:

A blinded assessment by three (3) independent evaluators was performed. The evaluators assessed before and 90-day post treatment* photographs of the subjects cheek area for improvement using the Lemperle Wrinkle Severity Scale (LWSS). When assessed at depth settings of up to 5mm, the mean change from baseline for the LWSS was 1.3 [95% CI: 1.22, 1.42]. The lower limit of the 95% confidence interval for the mean change is greater than 1.0, indicating that these data support the primary endpoint conclusion of 1 point or greater improvement. When the treatment was performed at up to 4mm, the LWSS change was 1.1. Safety Physician Reported Outcomes:

No Serious Adverse Events were reported. Nine (9) adverse events were reported in five (5) subjects. Of the nine, four (4) were considered Adverse Device Effects (ADEs). The ADEs were Black eye (bruising (1), cheek numbness (1), redness (1), and track marks on cheek (1). The ADEs were mild to moderate in severity and did not require intervention. All ADEs were anticipated risks of the device/treatment as listed in the device labeling. 72 LBL-00029 Rev 011

*NOTE: Due to the COVID-19 pandemic subject photographs were taken at Day 150 or Day 180 per protocol amendment. Cytrellis ellacor System with Micro-Coring Technology Operators Manual 73 Appendix C Error Codes, Messages, &

Troubleshooting If the System detects an error, the Error Screen displays on the Touchscreen. Some errors serve as a notification and are clearable by pressing the Continue button on the screen. Other errors indicate what action must be taken before the error can be cleared. If the error is successfully cleared, pressing the Continue button will allow the sequence of activities to resume. If an error cannot be cleared or if an error persists or reappears, refer to the toubleshooting guidance provided in Table 18. Table 17. Error Code Key Error Number Error Message Unique numerical value assigned to errors to facilitate troubleshooting. A description/explanation of the error. For alerts that require end-user action, the next step is included in the Error Message. Troubleshooting Guidance A set of sequential actions for the end-user to perform with the potential to eliminate the cause of the error. Table 18. Error Code, Messages, & Troubleshooting Guidance Error Number Error Message Troubleshooting Guidance 1, 2, 4, 9, 10, or 12 Actuation Error Clear area around Needle Cartridge. 8 Handpiece Not Powered Confirm that the Handpiece cable is attached to Console. 1) Clear area around Needle Cartridge. Ensure there are no obstructions preventing normal travel of the needles. 2) Press Continue to restart the Handpiece. 3) If problem persists, power cycle the Console (NOTE:

Needle Cartridge will become expired if the Console is turned off). 4) If problem persists, record error code and contact Cytrellis Customer Service. 1) Disconnect the Handpiece cable from the front of the Console and reconnect. 2) Press Continue. 3) If problem persists, power cycle the Console (NOTE:

Needle Cartridge will become expired if the Console is turned off). 4) If problem persists, record error code and contact Cytrellis Customer Service. 74 LBL-00029 Rev 011 Table 18. Error Code, Messages, & Troubleshooting Guidance Error Number Error Message Troubleshooting Guidance 32 or 65 Needle Alert Needle Damage Will Occur Decrease core depth setting or adjust treatment technique. 64 or 66 Actuation Error Clear area around Needle Cartridge 101 Vacuum Pressure Error Confirm all tubing connections from Console to Handpiece. 1) Check coring for precise holes, a full clean pattern should be visible. If not, replace Needle Cartridge. 2) Decrease <core depth> setting to prevent recurrence of this warning. Assess if the depth setting is appropriate for the treatment area. 3) Assess treatment technique to ensure minimal pressure is applied to the treatment area. 4) Clear area around the Needle Cartridge as needed. Ensure there are no obstructions preventing normal travel of the needles. 5) If problem persists, record error code and contact Cytrellis Customer Service. 1) Clear area around Needle Cartridge. Ensure there are no obstructions preventing normal travel of the needles. 2) Press Continue. 3) 4) If problem persists, replace the Needle Cartridge. If problem persists, record error code and contact Cytrellis Customer Service. 1) Check that Needle Cartridge tubing is connected to the suction tubing. 2) Check that suction tubing is connected to the filter. 3) Check that the filter is connected to the Console. 4) 5) If problem persists, power cycle the Console (NOTE:

Needle Cartridge will become expired if the Console is turned off). If problem persists, record error code and contact Cytrellis Customer Service. Cytrellis ellacor System with Micro-Coring Technology Operators Manual 75 Table 18. Error Code, Messages, & Troubleshooting Guidance Error Number Error Message Troubleshooting Guidance 1) When the system is sitting idle, blood may coagulate in tubing and filter resulting in blockages. Check that suction can be achieved at the treatment area. 2) If there is no suction, check for the following:

a. Suction tubing kinks b. Blockages in the Needle Cartridge tubing and 102 Vacuum Pressure Error Confirm tubing is not clogged or pinched. suction tubing c. Filter clogging needed. 3) Replace the Needle Cartridge, suction tubing or filter as 4) If problem persists, power cycle the Console (NOTE:

Needle Cartridge will become expired if the Console is turned off). 5) If problem persists, record error code and contact Cytrellis Customer Service. 1) Verify that the treatment room is within the specified operating environmental conditions listed in Appendix A. 2) Verify that there is adequate space around the Console to allow for proper air circulation, reposition the Console, as necessary. 3) Press Continue. To resume treatment, press Enable 4) Treatment. If problem persists, power off the Console and allow it to cool for 5 minutes (NOTE: Needle Cartridge will be expired if the Console is turned off). 5) Restart the Console and proceed through the setup screens. 6) If problem persists, record error code and contact Cytrellis Customer Service. 1) Verify that the treatment room is within the specified operating environmental conditions listed in Appendix A. 2) Press Continue. To resume treatment, press Enable 3) Treatment. If problem persists, unplug the Handpiece, record error code and contact Cytrellis Customer Service 103 or 104 Console Temperature Error Confirm adequate ventilation around the Console. 105 Handpiece Temperature Error Verify that the treatment room is within the specified operating environmental conditions. 76 LBL-00029 Rev 011 Table 18. Error Code, Messages, & Troubleshooting Guidance Error Number Error Message Troubleshooting Guidance 106 Maximum Core Count Exceeded Install new Needle Cartridge. 107 Handpiece Setup Error Clear area around Needle Cartridge. 108 109 110 or 113 Needle Cartridge Unlock Detected Not Allowed While in Treatment Mode Re-lock Needle Cartridge - then press Continue. Needle Cartridge can be removed when in Standby Mode Footswitch Down Release Footswitch before entering Treatment Mode. Console Communications Error Press Continue to retry. If problem persists, hold power button until device shuts off. Then restart. 1) Remove and discard Needle Cartridge (NOTE: The Needle Cartridge has been deactivated after reaching its maximum number of excised cores; 24,000 for the Triple Needle Cartridge and 8,000 for the Single Needle Cartridge). Install a new Needle Cartridge. 2) 3) Press Enable Treatment. 4) If problem persists, record error code and contact Cytrellis Customer Service. 1) Clear area around Needle Cartridge. Ensure there are no obstructions preventing normal travel of the needles. 2) Press Continue to restart the Handpiece. 3) If problem persists, power cycle the Console (NOTE:

Needle Cartridge will be expired if the Console is turned off). 4) If problem persists, record error code and contact Cytrellis Customer Service. 1) Do not unlock the Needle Cartridge when in Treatment Mode. 2) To resume the treatment with the same Needle Cartridge, re-lock the Needle Cartridge and press Continue. If trying to replace the Needle Cartridge, Re-lock the Needle Cartridge, press Continue, then enter Standby Mode before removing the Needle Cartridge. 3) 4) If problem persists, record error code and contact Cytrellis Customer Service. 1) Verify Footswitch is not pressed when trying to enter Treatment Mode. 2) If problem persists, record error code and contact Cytrellis Customer Service. 1) Press Continue to retry. 2) If problem persists, power cycle the Console (NOTE:

Needle Cartridge will be expired if the Console is turned off). 3) If problem persists, record error code and contact Cytrellis Customer Service. Cytrellis ellacor System with Micro-Coring Technology Operators Manual 77 Table 18. Error Code, Messages, & Troubleshooting Guidance Error Number Error Message Troubleshooting Guidance 111 Handpiece Error Confirm that the Handpiece cable is attached to Console. 112 or 207 201 or 202 Needle Deactivation Needle Cartridge has been deactivated due to potential needle damage. Install new Needle Cartridge. Defective Needle Cartridge Unlock and re-lock Needle Cartridge. If problem persists, install new Needle Cartridge. 203 Used Needle Cartridge Install new Needle Cartridge. 1) Disconnect the Handpiece cable from the front of the Console and reconnect. 2) Press Continue. 3) If problem persists, power cycle the Console (NOTE:

Needle Cartridge will be expired if the Console is turned off). 4) If problem persists, record error code and contact Cytrellis Customer Service. 1) Remove and discard Needle Cartridge (NOTE: Needle Cartridge has been deactivated to prevent treating with potentially damaged needles). Install a new Needle Cartridge. 2) 3) Press Enable Treatment. 4) Decrease <core depth> setting to prevent recurrence of this warning. Assess if the core depth setting is appropriate for the treatment area. 5) Assess treatment technique to ensure minimal pressure is applied to the treatment area. 6) If problem persists, record error code and call Cytrellis customer service. 1) Unlock and re-lock Needle Cartridge. 2) 3) If problem persists, replace Needle Cartridge with a new one. If problem persists, record error code and contact Cytrellis Customer Service. 1) Remove and discard Needle Cartridge (NOTE: Needle Cartridges are single-use only). Install a new Needle Cartridge. 2) 3) Press Enable Treatment. 4) For more information, record error code and contact Cytrellis Customer Service. 1) Remove Needle Cartridge. 204, 206, or 218 Defective Needle Cartridge Install new Needle Cartridge. Install a new Needle Cartridge. 2) 3) Press Enable Treatment. 4) Retain defective Needle Cartridge and packaging (if available), record error code and contact Cytrellis Customer Service. 78 LBL-00029 Rev 011 Table 18. Error Code, Messages, & Troubleshooting Guidance Error Number Error Message Troubleshooting Guidance 205 Needle Cartridge Attached but Unlocked Lock or remove Needle Cartridge. 208 Idle too long Resume treatment soon 209 210 211 Idle too long Remove Needle Cartridge. System Paused Press Continue to use system. Press Power Off to turn off system. Fewer than 50 patterns remain at current density 301 or 302 Power on Self-Test Failed Press Continue to retry. 1) Lock the Needle Cartridge. 2) Press Continue. 3) If problem persists, unlock and relock the Needle Cartridge. 4) Press Continue. 5) If problem persists, record error code and contact Cytrellis Customer Service. 1) Check that suction can be achieved at the treatment area before resuming. Replace Needle Cartridge, suction tubing, and filter as needed. 2) The Needle Cartridge will expire if treatment is not resumed soon. 3) For more information, record error code and contact Cytrellis Customer Service. 1) Remove and discard Needle Cartridge (NOTE: Due to inactivity, the Needle Cartridge has been deactivated). Install a new Needle Cartridge. 2) 3) Press Enable Treatment. 4) Check that suction can be achieved at the treatment area before resuming. Replace the suction tubing and filter as needed. 5) For more information, record error code and contact Cytrellis Customer Service 1) System paused due to inactivity. Press Continue to restart the Handpiece. 2) For more information, record error code and contact Cytrellis Customer Service. 1) This is a notification that the Needle Cartridge is approaching its maximum number of excised cores and will need to be replaced to continue treatment. 2) For more information, record error code and contact Cytrellis Customer Service. 1) Press Continue to retry. 2) If problem persists, hold the power button down for 3 seconds until the system turns off and back on. 3) If problem persists, record error code and contact Cytrellis Customer Service. Cytrellis ellacor System with Micro-Coring Technology Operators Manual 79

Information FCC Information NFC Device FCC ID: 2AUPV-830-00013 Model: 830-00013 Contains Cellular Module FCC ID: XPYZAGQN4NNN Model: MTQN-MNG1-B02.R1 (SARA-R410M)

(Manufactured by Multi-Tech Systems, Inc.) This device complies with Part 15 of the FCC Rules. Operation is subject to the following conditions:

1. This device may not cause harmful interference, and 2. This device must accept any interference received, including interference that may cause undesired operation. Changes and Modifications not expressly approved by Cytrellis can void your authority to operate this equipment under Federal Communications Commission's rules. Electronic Label, see page 61 of User Manual on how to access Version Information GUI PN: SW-00014 GUI Version: 1.0.4 G4-RG3 08/04/2021.6

$Revision: 305 $ Clinical Controller PN: SW-00007 Controller Version: B.0.1 07/26/2021.1 SVN:$Rev: 259 $

FPGA: "4967"

Handset Version: 4810 Built on: Oct 9 2018 15:41:05 loT PN: SW-00015 loT Version: 1.0.1

•

CYTRELLJ S

BIOSYSTEMS

Date: July 19, 2021

RE: FCC ID: 2AUPV-830-00013

To Whom It May Concern:

Please be advised that Steve Gemmell of Cytrellis Biosystems, Incorporated authorizes Larry

Stillings of Compliance Worldwide, Inc. to act on our behalf, until otherwise notified, for applications

submitted for the purpose of obtaining an FCC Grant of Equipment Authorization.

We certify that we are not subject to denial of federal benefits, that includes FCC benefits, pursuant

to Section 5301 of the Anti-Drug Abuse ACT of 1988, U.S.C. 862. Further, no party, as defined in

47 CFR 1.2002(b), to the application is subject to denial of federal benefits, that includes FCC

benefits.

Thank you for your attention to this matter.

Steve Gemmell

299( Wa shington Street, Woburn, MA 01801

•

CYTRELL J S®

B I OSYSTEMS

Date: July 19, 2021

Federal Communications Commission

Authorization and Evaluation Division

Confidentiality Request regarding application for certification of FCC ID: 2AUPV-830-00013

Pursuant to Sections 0.457 and 0.459 of the Commission's Rules, we hereby request

confidential treatment of information accompanying this application as outlined below:

Exhibit Type

Block Diagram

Schematics

Operational Description

File Name

2AUPV-830-00013 BlkDia. pdf

2AUPV-830-00013 Schem.pdf

2AUPV-830-00013 OpDes.pdf

The above materials contain trade secrets and proprietary information not customarily released

to the public. The public disclosure of these materials may be harmful to the applicant and

provide unjustified benefits to its competitors.

The applicant understands that pursuant to Section 0.457 of the Rules, disclosure of this

application and all accompanying documentation will not be made before the date of the Grant

for this application.

Pursuant to DA04-1705 June 15, 2004 of the Commission's public notice, we also require

temporary confidential treatment of information accompanying this application as outlined below

for a period of 180 days:

Exhibit Type

Internal Photos

Operational Manual

File Name

2AUPV-830-00013 lntPho.pdf

LBL-00029 Cytrellis Operators Manual

Temporary confidentiality for 180 days from public disclosure is important for Cytrellis

Biosystems from a commercial perspective. It enables the company to complete its

development and regulatory efforts prior to introducing the product to the marketplace.

Releasing information on the product via the FCC website prior to formal market introduction

can be confusing to our customers, and places the company at a competitive disadvantage.

Sin

rely,

Steve Gemmell

299C Washington Street, Woburn, MA 0180 1