FCC ID: 2AWH9-VJIII VERSAJET III

BRAND SKU VERSAJET III N/A COMPONENT User Manual PRODUCT Hydrosurgery System THIS BSC/REF 30958 PREV BSC/REF N/A DIMENSIONS A5 (24pp) COLOURS Match to coated stock PMS Black Pantone 1375 C (Cover only) CMY (Pages 6, 14 & 16 only) DATE 12.04.2022 REVISION 17 JOB NUMBER S38163 - 6389 ARTWORK MP CHECKED ARN VERSAJET III Hydrosurgery System User Manual Indications for Use Table of Contents 1. Description 2. 3. Safety 4. Contraindications 5. Warnings and Precautions 6. System components 7. Console System set-up Placement of the console Power cord socket Turning the console ON Setting up the Device 6.1 6.1.1 Front panel layout 6.1.2 Side panel 6.1.3 Rear panel layout Foot pedal 6.2 6.3 Single-Use Hand Piece 6.3.1 Hand Piece Options Instructions for Use 7.1 7.2 7.3 7.4 7.5 7.5.1 Connect the foot pedal 7.5.2 Connect the Hand Piece 7.5.3 Connect the Saline Bag(s) 7.5.4 Connect the Waste Canister Prime the Hand Piece 7.6 Debriding 7.7 Removal of an obstruction in the evacuation orifice 7.8 Changing the Saline Bag(s) 7.9 Replace Hand Piece 7.10 7.11 End of procedure 7.12 Hand piece quick set-up pictorial guide 8. Console cleaning and maintenance 8.1 8.2 Cleaning Maintenance 9. Disposal of the console and accessories 10. Troubleshooting Guide 11. Glossary of symbols 12. Technical information 13. System specifications 14. Environmental Conditions 15. Electromagnetic compatibility VERSAJET III Hydrosurgery System (REF 66802146) 16. Guidance and manufacturers declaration electromagnetic emissions VERSAJET III Hydrosurgery System (REF 66802146) 17. Warranty 18. Appendix A EN 4 4 4 4 4 5 5 5 5 6 6 7 8 9 9 9 9 9 9 9 9 10 10 10 10 11 11 11 11 12 13 13 13 13 14 16 16 17 17 18 20 21 Company position regarding the reprocessing and reuse of single-use only medical devices 22 19. Appendix B Ordering Information 22 3 EN 1. Description The VERSAJET III Hydrosurgery System consists of a console, foot pedal and a hand piece. There are different hand piece types for the VERSAJET III System for use in the operating room and outpatient setting, for further detail refer to section 6.3.1. This device can cut soft tissue. Apply only to tissues and debris intended to be excised from the wound. 2. Indications for Use The VERSAJET III Hydrosurgery System is intended for applications that in the healthcare professionals judgment, require sharp debridement:

wound debridement (acute and chronic wounds, burns), soft tissue debridement and cleansing of surgical sites. 3. Safety This user manual contains important information regarding the safe and effective operation of the VERSAJET III System. The system is designed for use by qualified and trained healthcare professionals. Improper system use or set up, or failure to follow this user guide may cause injury or damage not covered under the warranty. 4. Contraindications There are no known contraindications with the use of this device. 5. Warnings and Precautions This device is not suitable for use in an oxygen rich environment (e.g. oxygen tent, hyperbaric chamber). DO NOT directly expose the console to a flammable anesthetic mixture. In order to avoid unwanted procedural delays, ensure the system is fully operational prior to administration of anesthesia. This device should be used with particular care in patients with hemophilia or other blood clotting disorders and in patients receiving anti-coagulant medication. This device can cut soft tissue. Apply only to tissues and debris intended to be excised from the wound. Increasing console power settings will lead to more aggressive tissue removal. Use caution near delicate vessels and structures, such as neurovascular bundles. When used on wounds where bone, tendon 4 or other hard tissue (e.g. leathery eschar) may be encountered during the debridement procedure, excessive spraying and/or misting may occur due to the interruption of the stream of sterile saline by hard tissues. DO NOT touch the high-pressure jet in the operating window of the hand piece. As with all surgical procedures, the VERSAJET III System operator and other clinical personnel should follow the universal precautions for infection control. Examine all components before use. DO NOT use, if you believe a component to be faulty or damaged. Contact your local Smith+Nephew VERSAJET III System representative. DO NOT use if the hand piece packaging seal is broken or the pouch is damaged. Place the console and waste canister onto flat and stable surfaces to prevent the console and waste canister from tilting or falling. DO NOT cover the air vents on the side of the console. A minimum of 12 cm clearance is advised to prevent the system from overheating. DO NOT pull hand piece tubing in an attempt to bring the console closer for use. Select an appropriate waste canister for the procedure. DO NOT connect the waste evacuation tubing hose or any container connected to it, to a vacuum source. DO NOT preheat saline before use the device. Use only sterile saline solution with this device. The VERSAJET III Hydrosurgery System Hand Piece and VERSAJET III Hydrosurgery System Console are not compatible with previous generations of the VERSAJET console and hand pieces respectively. Each VERSAJET III Hand Piece is intended for SINGLE-USE ONLY. DO NOT RE-STERILIZE. Device performance will be compromised and sterility cannot be assured. Discard appropriately after use. Refer to our company position regarding the reprocessing and reuse of single-use only medical devices in Appendix A of this manual. DO NOT use where there is any significant risk of reciprocal interference between the VERSAJET III Console and another medical device or treatment. To avoid the risk of electric shock, this equipment must only be connected to supply mains with protective earth. No modification to this equipment is allowed. Modifications could lead to electric shock. Use of non-consigned parts (e.g. non-

compatible hand piece, power cord and foot switch) will result in malfunction of device. EN 6. System components The VERSAJET III System consists of four primary components:

Reusable Equipment:

Console Foot pedal Power cord Single-Use Equipment:

Single-use hand piece and associated tubing 6.1. Console The VERSAJET III Console is an electrically powered device that controls the pumping of high-pressure saline through the hand piece, providing hydrosurgical debridement. A foot pedal and power cord are provided with the console. 6.1.1. Front panel layout 1 2 3 4 5 6 1. Illuminated power switch turns the power ON and OFF 2. Foot pedal socket interfaces with the foot pedal 3. 7-inch LED Touchscreen Display displays the set-up guidance, power setting, and service information. Power settings can sequentially be selected from 1 (lowest) through 10 (highest). 4. Hand Piece insertion port secures the hand piece to the console 5. Key lock symbols provide the user information on the hand piece pump positions

(Unlocked and Locked) 6. Type BF Applied Part the hand piece has a type BF rating 6.1.2. Side panel 1 1. Side air vents allow for air to enter the console to cool the motor 5 EN 6.1.3. Rear panel layout 1 2 VERSAJET III Hydrosurgery System Console 66802146 100-240V~ 50/60Hz 600W T 6.3A H x2 250V IPX3 YYYY-MM-DD FCC ID: 2AWH9-VJIII Smith & Nephew Medical Limited, 101 Hessle Road, Hull HU3 2BN, England 2022 Smith+Nephew. Trademark of Smith+Nephew Certain marks Reg. US Pat. & TM Off. This product may be covered by one or more US Patents. See: www.smith-nephew.com/patents 30721 3 1. Power cord socket interfaces with the detachable power cord through a three-prong socket

- The power cord provides electrical power to the console from an electrical outlet. For details of available power cords, please refer to the Ordering Information section. 2. Protective earth ground terminal allows connection to the main system ground for testing the equipment 3. Device label contains information and symbols specific to the device 6.2. Foot pedal NOTE: Only a VERSAJET III Foot Pedal should be used with the VERSAJET III Console. 2 1 4 5 VERSAJET III 3 1. UP button pressing the button next to the UP arrow increases the power setting 2. DOWN button pressing the button next to the DOWN arrow decreases the power setting 3. Foot pedal pressing the foot pedal activates the motor 4. Foot pedal cable connects the foot pedal connector to the foot pedal 5. Foot pedal connector connects the foot pedal to the socket on the console 6 EN 6.3. Single-Use Hand Piece The sterile VERSAJET III Hand Piece and associated tubing should be disposed of after use as clinical waste. The hand piece has an operating window located at the instruments distal tip. When the system is in operation, a stream of pressurized saline travels across the opening and creates a localized vacuum effect, following the principles of the Venturi effect. By applying/passing the operating window over the area to be debrided the user can excise nonviable tissue and contaminants. The system can be used to cut, ablate and remove tissue and foreign matter from wounds and to resect and remove material in a variety of surgical applications. CAUTION: The VERSAJET III Hand Piece and VERSAJET III Console are not compatible with previous generations of the VERSAJET console and hand pieces respectively. NOTE: The VERSAJET III Hand Piece is only designed for connection to the VERSAJET III Console (66802146). DO NOT attempt to connect to any other equipment. 1 6 8 2 3 7 5 4 1. Clam shell a clear plastic enclosure that holds the hand piece and pump cartridge 2. Pump cartridge (orange connector) connects the hand piece to the console 3. Saline Inflow tube two clear tubes with white spike and pinch clamp that connects to saline bags 4. Instrument tip the metal tip (PRECISION Hand Piece) or plastic tip (PROCLINICAL Hand Piece) with a small, precise opening where a high velocity stream of sterile saline selects and excises non-viable tissue and contaminants contained in the operating site. The instrument tip contains the evacuation orifice 5. Hand piece an ergonomic handle supporting the instrument tip; receives the high-pressure line and waste evacuation line at the proximal end (white) 6. Waste evacuation tube a clear tube with a blue connector end that carries evacuated fluid, non-viable tissue and contaminants to an appropriate waste container 7. High pressure tube a tube that carries pressurized saline to the distal tip of the hand piece 8. Saline inflow tube 7 6.3.1. Hand Piece Options There are two single-use VERSAJET III hand piece types PRECISION and PROCLINICAL. VERSAJETIII PRECISION Hydrosurgery System Hand Piece 15 45 45 14mm 14mm 8mm Order no. Description 66802147 VERSAJET III PRECISION Hand Piece

(15/14mm) For operating room only 66802148 66802149 VERSAJET III PRECISION Hand Piece

(45/14mm) For operating room and outpatient setting VERSAJET III PRECISION Hand Piece

(45/8mm) For operating room and outpatient setting VERSAJETIII PROCLINICAL Hydrosurgery System Hand Piece This Hand Piece has a 20 minute continuous debridement time limit. 45 45 14mm Order no. Description 66802150 VERSAJET III PROCLINICAL Hand Piece

(45/14mm) For outpatient setting only 66802151 VERSAJET III PROCLINICAL Hand Piece

(45/8mm) For outpatient setting only 8mm 8 EN 7. Instructions for Use It is recommended that prior to clinical use of VERSAJET III System, all operators of the device should be trained in the proper use of VERSAJET III System. Smith+Nephew Representatives will be available to provide a tailored introduction to the use of the system, on the request of the clinician. Contact your local representative for details. In order to avoid unwanted procedural delays, ensure the system is fully operational prior to the administration of anesthesia. 7.1. System set-up This section provides the procedures for set up and operation of the VERSAJET III System. NOTE: To ensure adequate saline supply is selected, consider the power setting to be used for the procedure and procedure length. To calculate the saline volume required, refer to the Flow Rates and Pressures table below. Flow Rates and Pressures Values provided in the table are typical values and are provided as guidance only. Actual values may vary. Power Setting 1 2 3 4 5 6 7 8 9 10 VERSAJET III Hand Piece Flow Rate

(mL/min) 82 96 110 123 137 150 167 179 189 197 Pressure

(psi / bar) 1448/100 1962/135 2518/174 3139/216 3856/266 4635/320 5713/394 6549/452 7308/504 7950/548 7.2. Placement of the console Place the console on a stable, flat surface, close for operating purposes. Ensure the side air vents are not covered. CAUTION: DO NOT block the air vents, on the bottom or sides of the console, during use. Failure to do so could lead to overheating issues. CAUTION: DO NOT pull hand piece tubing in an attempt to bring the console closer for use. 9 EN 7.3. Power cord socket CAUTION: Before connecting the device to an electrical outlet, ensure that you have selected the appropriate power cord for the local power requirements and that the device is connected to a socket that meets the system requirements. Failure to do so may cause damage to the equipment and void the warranty. CAUTION: DO NOT position the VERSAJET III Console so it is difficult to disconnect the power supply from the mains supply. 1. Insert the power cord into the back of the console. 2. Plug the power cord into an appropriate electrical outlet. 7.4. Turning the console ON Press the power button. The button will illuminate, following which the display will start up. 7.5. Setting up the Device Select Start Set-up to initiate the set-up guidance. CAUTION: DO NOT use a sharp tool or apply excessive force on the power button and the touch-screen display. 7.5.1. Connect the foot pedal 1. Connect the foot pedal connector into the foot pedal socket on the front of the console, ensuring the red dots on the connector and socket are aligned. Once the connection is achieved, a green tick will appear on the screen. 2. Position the foot pedal for convenient access. 7.5.2. Connect the Hand Piece 1. Remove the pouch from carton. Inspect pouch to ensure seals are intact and pouch is undamaged. Open the pouch, ensuring that the sterility of the inner pouch is not compromised. 2. Aseptically transfer inner pouch and contents to the sterile field (in the operating room) or onto a sterile surface

(in an outpatient environment). 3. Aseptically inspect inner pouch to ensure seals are intact and pouch is not damaged. Open inner pouch, remove the sterile contents and place securely in the sterile field or onto a sterile surface. Avoid tangling of the tubing. EN 4. Remove the hand piece from the clam shell and place in the sterile field or onto a sterile surface. DO NOT remove the orange connector (pump cartridge) from the clam shell tray. 5. Uncoil the tubing lines. DO NOT remove orange bands surrounding the tubing. Maintain aseptic technique for the hand piece and sufficient tubing to allow access to the surgical site. 6. Remove the orange connector from the clam shell and insert the metal end into the connection port on the front of the console. Rotate the connector clockwise to the lock position. Once the connection is achieved, a green tick will appear on the screen. 7.5.3. Connect the Saline Bag(s) It is recommended that full saline bags are connected prior to commencing with the procedure. CAUTION: Only spike the saline bag(s) once the hand piece has been connected to the console. Failure to do so may result in fluid leakage from the pump cartridge. CAUTION: Do not preheat saline before use of the device. CAUTION: The system can be operated with either one or two saline bags. If only one bag is required, leave the unused inflow line clamp closed and the bag spike cap on. 1. Ensure the inflow line clamp is closed. 2. Remove the sterile cover from the bag spike and insert into the saline supply bag. Repeat for the second bag if necessary. 3. Press the right arrow on the screen to proceed to the next step. NOTE: The saline bag MUST be placed a minimum of 24in/60cm above the console. 7.5.4. Connect the Waste Canister CAUTION: Place the waste canister onto a flat and stable surface to prevent the waste canister from tilting or falling. 1. Attach the waste evacuation tube (blue tip) to the waste canister. CAUTION: DO NOT connect to a port containing a filter or to the VACUUM port. Ensure there is an additional open port on the waste canister lid, to prevent a pressure build-up inside the canister. 2. Ensure there are no kinks or other external obstructions in the tubes. NOTE: The waste canister should be below the level of the hand piece during priming and debriding. CAUTION: To avoid the canister overflowing, ensure the waste canister volume will contain the volume of saline used during the procedure. 3. Press the right arrow on the screen to complete the set-up. CAUTION: Monitor the waste canister and ensure it is emptied to prevent overflowing. 7.6. Prime the Hand Piece 1. Remove the protective cover from the tip of the hand piece. 2. Initiate the priming sequence on the screen. 3. Power levels will automatically increase from 1 to 10. 4. Open the saline clamps. 5. While holding the hand piece at a safe distance, depress the foot pedal and observe a steady flow of saline at the distal tip of the hand piece. NOTE: A visible saline stream flowing down the waste tube, indicates priming is complete. 6. Release the foot pedal. Indicate that the priming is complete on the screen. CAUTION: Once the system has been primed with saline, do not allow the saline bag to empty. An empty bag can cause air to enter the system and require re-priming of the system. NOTE: Do not place the hand piece tip too close to eyes to avoid saline splash to eyes. 7.7. Debriding Once priming is complete the system is ready for debridement. To prevent saline splashing back into the eyes, avoid bringing the hand piece tip close to the eyes during use. CAUTION: This device can cut soft tissue. Apply only to tissues and debris intended to be excised from the wound. NOTE: For optimal results when debriding hard or leathery eschar resulting from 10 burn injuries, it is recommended to first debride the eschar using sharp debridement techniques followed by the use of VERSAJET III System to complete debridement or excision of the wound. 1. To begin debriding, begin at the lowest power setting and increase as necessary. The power setting can be adjusted using the UP and DOWN buttons on the foot pedal, or the + and buttons on the screen. When the foot pedal is active the + and buttons on the screen will be inactive. WARNING: Increasing the console power setting will lead to more aggressive tissue removal. Use caution near delicate vessels, structures and surrounding tissues. CAUTION: Monitor the waste canister and ensure it is emptied to prevent overflowing. NOTE: Spraying or misting is more frequent at lower power settings due to reduced pressure. Spraying or misting may be reduced by keeping the waste evacuation tube straight. 2. While securely holding the hand piece, depress the foot pedal to activate the motor. A constant stream of saline will appear at the distal tip of the hand piece. 3. Position the distal tip over the area requiring debriding. 4. Release foot pedal before removing the hand piece from the wound. NOTE: The VERSAJET III PROCLINICAL Hand Piece has a 20 minute continuous debridement time limit. The time counter is only active when the foot pedal is depressed and debridement is conducted. Once the 20 minutes are completed, if further debridement is required, a second hand piece will need to be connected to the console. NOTE: If leaking is observed at the connection interface to the console, please remove and replace the hand piece with a new one. 7.8. Removal of an obstruction in the evacuation orifice If the evacuation orifice becomes blocked with foreign matter, a reduction in device efficiency or the presence of spray from the instrument tip may result. To remove the obstruction:

1. Remove the hand piece from the wound site. 11 EN 2. Release the foot pedal and remove the obstruction with forceps. NOTE: Avoid touching the opening in the high-pressure jet with forceps. 3. Once the obstruction is removed, depress the foot pedal and check for steady stream of sterile saline flow. 4. If the obstruction is not completely removed, repeat the hand piece set-up and system priming procedure or check that the waste evacuation tube is not pinched by forceps, stepped on or that the collection container is full. 7.9. Changing the Saline Bag(s) When using one saline bag: If additional saline is required, attach an additional bag to the second line prior to the first bag emptying. Open the second saline line clamp prior to the first bag emptying. When using two bags: Open the second inflow line prior to the first bag emptying. Should additional saline be required for the debridement, ensure the clamp is closed prior to changing the bag. NOTE: Monitor the saline levels during use to ensure the bags are replaced prior to emptying. 7.10. Replace Hand Piece If a notification appears on the screen with instructions to replace the hand piece, please disconnect the saline bag(s), waste canister, and hand piece from the console. Press OK on the notification and proceed to set up a new hand piece. 7.11. End of procedure 1. After completing the procedure, disconnect the saline bags, waste canister, hand piece and foot pedal. 2. Discard the hand piece in accordance with your local healthcare facilitys standard guidelines for biohazardous waste disposal. 3. Switch the device off by pressing the power button. 4. Disconnect the power supply cable. NOTE: After each use, thoroughly clean the console, foot pedal and power cord. Please refer to the Cleaning and Maintenance section. 7.12. Hand piece quick set-up pictorial guide A C B A C B 12 EN 8.2. Maintenance Smith+Nephew recommends that dielectric strength, earth leakage current and protective earth testing be performed annually to assure continued compliance with applicable safety requirements. These tests should be conducted in accordance with specifications UL 60601-1/

IEC 60601-1. CAUTION: Electrical safety testing should be performed by a biomedical engineer or other qualified person. CAUTION: Device should be repaired by authorized person only. Brightness and Language can be changed under the Menu. However, the Maintenance Menu is password protected and can only be accessed by an authorized person. A physical appearance check and system diagnostics check should be performed annually, or following 240 hours of debridement, as part of the maintenance routine for VERSAJET III System. The device will notify you at 230 hours that there are 10 debridement hours remaining, and to prompt you to arrange for your device to be sent for maintenance. 9. Disposal of the console and accessories At the end of the consoles expected service life (5 years), it should be disposed of in accordance with local laws and regulations. Please contact Customer Care at 1-800-876-1261 (USA only) or local Smith+Nephew representative to return a console for repair or replacement. 8. Console cleaning and maintenance 8.1. Cleaning Follow your healthcare facilitys standard procedures for decontaminating surgical equipment to decontaminate the console, foot pedal and power cord. The following are the recommendations for console decontamination:

1. Wear protective gloves, gown and eye wear. 2. Wipe all surfaces of the console and foot pedal with a disposable towel or cloth soaked in the disinfectant solution. 3. Dilute the disinfectant solution according to the manufacturers instructions. After disconnecting the foot pedal and power cord from the console, wipe down all exposed surfaces of both components in accordance with the guidance for the console. 4. Dispose of towels, gloves and gown in accordance with your healthcare facilitys standard guidelines for biohazardous waste disposal or as prescribed by the environment in which the console was used. This procedure should be performed after each console use. The fan slot and vents on the sides of the console should be kept free from obstructions and periodically inspected for excessive build-up of dust and/or foreign material. The pump interface should be inspected periodically for build-up of deposits and/or debris. A damp cloth with mild detergent can be used to remove material. NOTE: Using a wet cloth or excessive fluid to clean the console can cause damage. If the power cord or foot pedal are damaged, these should be replaced. Please refer to Appendix B, Ordering Information. 13 EN EN 10. Troubleshooting Guide Follow the below troubleshooting steps. If the fault is not resolved, contact Customer Care at 1-800-876-1261 (USA Only) or your local Smith+Nephew Representative. Fault Potential Cause Solution No / intermittent electrical power Console power switch not illuminated Press power switch; power switch should become illuminated Power not present at electrical outlet Ensure that the electrical outlet has power Connect to a different electrical outlet Power cord not connected or connected loosely at console or electrical outlet Note: The console will default to power level 1 if power is interrupted Foot pedal not connected properly Ensure that power cord is:

Fully seated into the back of the console and electrical outlet Not damaged and free of defects If the fault persists, order a replacement power cord. Observe red alignment dots on foot pedal connector and foot pedal socket are properly aligned Ensure the foot pedal connector is fully inserted Foot pedal obstructed Ensure that there are no objects obstructing the Foot Pedal from being depressed or releasing Foot pedal inoperative Order replacement foot pedal (66802155) from Customer Care Hand piece is removed Connect new hand piece Console fails to recognize hand piece Connect new hand piece Hand piece is loosing Rotated and locked hand piece Foot pedal notification window appears on screen Hand piece notification window "Hand piece disconnected" appears on screen Hand piece notification window "Hand piece not recognized" appears on screen Hand piece notification window "Hand piece unlocked" appears on screen Hand piece notification window "time ended"

appears on screen PROCLINICAL hand piece accumulated debridement time reaches limit Connect new hand piece System fault notification window appears on screen Power fault caused by over-current or System Over Pressure condition out of tolerance 1. Turn console OFF by pressing power switch 2. Ensure power cord is connected to an appropriate power source. If necessary, try a different electrical outlet 3. Ensure the yellow high-pressure tube on Hand piece is not kinked, obstructed or tangled 4. Wait at least 5 seconds after turning OFF 5. Turn console ON by pressing power switch 6. Should the problem persist contact Customer Care, 1-800-876-1261 (USA only) or local Smith+Nephew representative to arrange a return System overheating notification window appears on screen Side vent and/or fan fence are blocked 1. Turn console OFF by pressing power switch 2. Check the side vent hole and fan fence, clean and remove obstructers if any;

3. Wait 10 minutes to let console cooling;

4. Restart the console. Console damage

(e.g. fan stops) Stop using device. Contact Customer Care at 1-800-876-1261 (USA Only) or your local Smith+Nephew Representative 14 EN Follow the below troubleshooting steps. If the fault is not resolved, contact Customer Care at 1-800-876-1261 (USA Only) or your local Smith+Nephew Representative. Fault Potential Cause Solution Hand piece does not Prime No / obstructed fluid supply 1. Ensure saline bag is full and fluid flows freely 2. Check that pinch clamp is fully open Note: Priming takes approximately 1 min at power level 10 3. Check high pressure tube for kinks, obstructions or leaks 4. Ensure saline bag is set at least 24in / 60cm higher than the console 5. Reconnect or replace as necessary. Air in saline inflow line 1. Open the pinch clamps of both saline bags to Excessive spray /

spattering Note: Hand piece should not come into contact with bone tissue as it obstructs fluid flow and causes spraying release the air trapped in tube. 2. While keeping hand piece at a safe distance set console power level to 10 and depress foot pedal to remove air from the pump and resume priming 3. If only one saline bag is connected, connect a saline bag to the unused line and open the clamp to release the trapped air. CAUTION: Ensure continuous flow of saline. DO NOT allow saline bag to empty completely before changing Obstruction of evacuation orifice (debris, tissue or other foreign material)

(Section 8.8 page 11) 1. Release foot pedal 2. Remove hand piece from wound 3. Remove obstruction with forceps 4. Re-prime hand piece Obstructed waste evacuation tube 5. If the obstruction is not completely removed, repeat the hand piece set-up and system priming procedure. 6. Check that the waste evacuation tube is not pinched by forceps, stepped on or that the collection container is full. Ensure that:

The distal end of the evacuation tube is connected to a non-filtered port of a waste collection container Waste container is vented Evacuation tube is not obstructed, kinked or pinched Waste container is at lowest possible point below console level Waste container is not full Saline supply is above console (provides gravity feed/pressure) Screen blanks out and power button LED flashing Fluid jet striking edge of metal evacuation orifice Replace hand piece. Return initial hand piece by contacting Customer Care at 1-800-876-1261

(USA only) or local Smith+Nephew representative Screen is damaged 1. Stop using device. 2. Contact Customer Care, 1-800-876-1261

(USA only) or local Smith+Nephew representative to arrange a return Contact Customer Care at 1-800-876-1261 (USA Only) or your local Smith+Nephew Representative 15 EN 11. Glossary of symbols Follow instructions for use Consult instructions for use Do not re-use Lot number Date of manufacture Serial number Sterilized using ethylene oxide Manufacturer Do not use if package is damaged Keep Away From Sunlight Product catalog number Keep dry Temperature limitation Humidity limitation Atmospheric pressure This way up Non-ionizing electromagnetic radiation Caution: U.S. Federal law restricts this device to sale by or on the order of a physician. Equipment classification Isolation type BF applied part Fuse Rating Caution Brightness Federal Communications Commission Certification Identification Number FCC ID: 2AWH9-VJIII 12. Technical information CAUTION: Only VERSAJET III System equipment should be connected to the console. There are no user serviceable parts within the console. All required service must be performed by the manufacturer. Contact Customer Care at 1-800-876-1261 (USA only) or local Smith+Nephew representative to return console for repair or replacement. 16 13. System specifications Front panel Power switch, ON/OFF (I/O) Foot pedal connection Hand piece unlocked EN Product dimensions and weights Console Size 40cm W x 35cm D x 18cm H 15.8in W x 13.8in D x 7.1in H Weight 13.6kg / 30lbs IP classification IPX3 Footswitch Size 19cm W x 18.4cm D x 5cm H 7.5in W x 7.25in D x 2in H Weight 1.7kg / 3.7lbs Cord length 4.6m / 15ft Hand piece locked IP classification IPX8 Power cord Adjusting Power Setting Length 4.6m / 15ft (US) Rear panel Prior to connecting the device to an electrical outlet, determine local voltage and electrical supply requirements. Ensure the cable is compatible. Power inlet Power cord IEC60320-1 C14 style power inlet with dual fuse holder Detachable hospital grade power cord with C13 plug 14. Environmental Conditions Single-use hand piece environmental conditions Unless otherwise stated, the following conditions apply for product use as well as shipping and handling. Temperature range Storage 41F (5C) to 77F (25C) Product use 50F (10C) to 90F (32C) Power input rating 100-240V~ 50/60Hz 600W T 6.3A H x2 250V Humidity range Fuse ratings Dual T 6.3A H 250V 5x20mm Mode of operation Continuous Atmospheric pressure 10% to 90% RH, non-condensing 700 to 1060 hPa Applied part classification Equipment classification Compliance Listing Type BF Class I IEC60601-1 IEC60601-1-6 To be defined Console environmental conditions Unless otherwise stated, the following conditions apply for product use as well as shipping and handling. Temperature range Storage

-4F (-20C) to 131F (55C) Product use 50F (10C) to 90F (32C) Humidity range Atmospheric pressure 10% to 90% RH, non-condensing 700 to 1060 hPa 17 EN 15. Electromagnetic compatibility VERSAJET III System

(REF 66802146) This equipment has been tested and found to comply with the limits for medical devices to IEC 60601-1-2-2014 4th edition as a Class B digital device, pursuant to part 15 of the FCC Rules. These limits and test levels are intended to provide reasonable safety with regard to electromagnetic disturbances when the device is used in a typical medical installation. Operation is subject to the following two 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. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

- Reorient or relocate the receiving antenna.

- Increase the separation between the equipment and receiver.

- In case of the power supplier of the Relay Antenna connect the equipment into an outlet on a circuit different from that to which the receiver is connected.

- Consult the dealer or an experienced radio/TV technician for help. The field strength of radiated emission is below 150 microvolts/meter from 88 MHz to 13 GHz. This device does not have essential performance. The Wireless Quality of Service (QoS) in VERSAJET III System is implemented in the only wireless RFID/NFC communication between the VERSAJET III console and VERSAJET III Hand piece. This device use RFID to recognize the hand piece. The field strength of radiated emission is below 62.5 db microvolts/meter at operating frequency 13.56 MHz. The communication range between hand piece and console is less than 50mm. There is no harm when RFID is interfered but suggest to keep separate distance more than 50mm with other RFID devices/tags. IC (Industry Canada) Statement Antenna Statement Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry Canada. To reduce potential radio interference to other users, the antenna type and its gain should be so chosen that the equivalent isotropically radiated power (e.i.r.p.) is not more than that necessary for successful communication. Conformment la rglementation d'Industrie Canada, le prsent metteur radio peut fonctionner avec une antenne d'un type et d'un gain maximal (ou infrieur) approuv pour l'metteur par Industrie Canada. Dans le but de rduire les risques de brouillage radiolectrique l'intention des autres utilisateurs, il faut choisir le type d'antenne et son gain de sorte que la puissance isotrope ayonne quivalente (p.i.r.e.) ne dpasse pas l'intensit ncessaire l'tablissement d'une communication satisfaisante. Canadian Department of Communications Compliance Statement CAN ICES-3(B)/NMB-3(B) Guidance and manufacturers declaration - electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the VERSAJET III System (REF 66802146), including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. 18 Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidelines EN Floors should be wood, concrete or ceramic tile. If floors are synthetic, the relative humidity should be at least 30%. 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 device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or battery. Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short Interruptions and voltage variations on power supply input lines IEC 61000-4-11 8 kV contact 2 kV, 4 kV, 8 kV, 15 kV air 2 kV For power supply lines 100 kHz repetition frequency 0.5 kV, 1 kV Line-to-line 0.5 kV, 1 kV, 2 kV Line-to-ground At 0, 45, 90, 135, 180, 225, 270 and 315 phases 0% UT

(100% dip in UT) for 0.5 cycle At 0 single phase 0% UT

(100% dip in UT) for 1 cycle 70% UT

(30% dip in UT) for 25/30 cycles 0% UT

(100% dip in UT) for 250 cycles 0% UT

(100% dip in UT) for 300 cycles 8 kV contact 2 kV, 4 kV, 8 kV, 15 kV air 2 kV For power supply lines 100 kHz repetition frequency 0.5 kV, 1 kV, Line-to-line 0.5 kV, 1 kV, 2 kV Line-to-ground At 0, 45, 90, 135, 180, 225, 270 and 315 phases 0% UT

(100% dip in UT) for 0.5 cycle At 0, 180 phase 5% UT

(100% dip in UT) for 0.5 cycle 40% UT

(60% dip in UT) for 5 cycles 5% UT

(100% dip in UT) for 5 seconds At 0 single phase 70% UT

(30% dip in UT) for 25/30 cycles 0% UT

(100% dip in UT) for 5 seconds NOTE UT is the a.c. mains voltage prior to application of the test level Power frequency

(50/60Hz) magnetic field IEC 61000-4-8 Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 30 A/m 50 or 60 Hz 30 A/m 50 or 60 Hz Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Portable and mobile communications equipment should be separated from the device by no less than distances calculated/listed below:

Recommended separation distance:

3 Vrms 150 kHz to 80 MHz 6 Vrms 150 kHz to 80 MHz In ISM radio bands 3 Vrms 150 kHz to 80 MHz 6 Vrms 150 kHz to 80 MHz In ISM radio bands d= 0,58 P 3 V/m 80 MHz to 2.7 GHz IEC 60601-1-2:2014 Table 9 3 V/m 80 MHz to 2.7 GHz IEC 60601-1-2:2014 Table 9 d= 0,175 P (80 MHz to 800 MHz) d= 0,35 P (800 MHz to 2.7 GHz) NOTE 1: At 80 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. a. Field strengths from fixed transmitters, such as base stations for radio (cellular/

cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuacy. 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 device is used exceeds 3 V/m, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 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, ashould be less than the compliance level in each frequency range b. Interference may occur in the vicinity of equipment marked with the following symbol:

19 EN 16. Guidance and manufacturers declaration electromagnetic emissions VERSAJET III System (REF 66802146) The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Emissions test RF emissions CISPR 11 Compliance Group 1 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/

flicker emissions IEC 61000-3-2 Class B Class A Comply Electromagnetic environment guidelines The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause interference in nearby electronic equipment. The device is suitable for use in all establishments including domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. WARNING: The device should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the device should be observed to verify normal operation in the configuration in which it will be used. Do not use cables and accessories other than those specified or sold by Smith+Nephew as it may result in increased electromagnetic emissions or decreased electromagnetic immunity of the VERSAJET III System (REF 66802146). Portable and mobile RF communication devices (mobile telephones) can affect VERSAJET III System (REF 66802146). Recommended separation distances between portable and mobile RF communications equipment and the device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment

(transmitters) and the device as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter

(W) Separation distance according to frequency of transmitter (m):

150 kHz to 80 MHz d= 0.58 P 80 MHz to 800 MHz d= 1.17 P 800 MHz to 2.7 GHz d= 2.3 P 0.01 0.1 1 10 100 0.06 0.2 0.6 1.8 5.8 0.12 0.37 1.2 3.7 11.7 0.23 0.74 2.3 7.4 23 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 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. 20 17. Warranty Limited one-year warranty S&N products are warranted to conform in all material respects to S&Ns standard specification for a particular product in effect at the time of product delivery to the buyer

(including any tolerance parameters) for the warranty period specified for the products at www.SNWarranties.com. EN 21 EN 18. Appendix A Company position regarding the reprocessing and reuse of single-use only medical devices As a manufacturer of single-use medical devices, including multi-use systems with single-

use patient contact components, it is our position that these devices are not designed or manufactured to withstand the rigors of reprocessing and therefore should not be reprocessed. Single-use medical devices are intended to be used on an individual patient during a single procedure and then discarded. They are not intended to be reprocessed and used again. Labelling identifies such devices as single-use. The use of reprocessed devices may present unacceptable risks to the health and safety of patients and healthcare professionals. Tissue and organ damage as well as cross-infection can result from the reuse of a single-use device, because of practical issues of cleaning single-use devices. Moreover, the rigors of reprocessing can impair the performance and adversely affect the safety of a single-use device, as a result of changes in the physical state of the device. 19. Appendix B Ordering Information Ordering information 66802146 VERSAJET III HYDROSURGERY SYSTEM CONSOLE 66802147 VERSAJET III PRECISION 15 x 14mm 66802148 VERSAJET III PRECISION 45 x 14mm 66802149 VERSAJET III PRECISION 45 x 8mm 66802150 VERSAJET III PROCLINICAL 45 x 14mm 66802151 VERSAJET III PROCLINICAL 45 x 8mm 66802152 VERSAJET III CONSOLE USER MANUAL 66802153 VERSAJET III HAND PIECE USER MANUAL 66802154 VERSAJET III CART1 66802155 VERSAJET III MULTI-FUNCTIONAL FOOT PEDAL 66800193 POWER CORD, NORTH AMERICA 66800213 POWER CORD, UNITED KINGDOM 66800291 POWER CORD, CENTRAL EUROPE 66800302 POWER CORD, SOUTH AFRICA 66800303 POWER CORD, AUSTRALIA / NEW ZEALAND 66801308 POWER CORD, PHILIPPINES 66801056 CHINA POWER CORD PACK OF 1 66801063 VERSAJET III Speed Stick (RPM verification) tool 15/14mm 45/14mm 45/8mm 45/14mm 45/8mm To order, contact Customer Care at 1-800-876-1261 (USA only) or local Smith+Nephew representative 1 Refer to the user manual of optional compatible cart for using instruction. 22 Smith & Nephew Medical Limited, 101 Hessle Road, Hull HU3 2BN England Customer Care Center 1 800-876-1261 www.smith-nephew.com www.educationunlimited.smith-nephew.com 2022 Smith+Nephew Trademark of Smith+Nephew Certain marks Reg. US Pat. & TM Off. This product may be covered by one or more US Patents. See: www.smith-nephew.com/patents 04/2022 30958 BRAND SKU VERSAJET III N/A COMPONENT User Manual Review PRODUCT Hydrosurgery System THIS BSC/REF 31230 BASED ON 27441 DIMENSIONS 215.9 x 279.4 (2pp) COLOURS Match to coated stock PMS Black Pantone 1375 C (One side only) DATE 03.03.2022 REVISION 04 JOB NUMBER S38181 - 6433 ARTWORK MP CHECKED ARN System Installation VERSAJET III PRECISION/

VERSAJET III PROCLINICAL Hydrosurgery System Hand Piece A C B A C B VERSAJET III PRECISION/

VERSAJET III PROCLINICAL Hydrosurgery System Hand Piece Do not use contents if package is opened or damaged. Single use Hand Piece Assembly Do not re-sterilize. Indications for Use The VERSAJET III Hydrosurgery System is intended for applications that in the healthcare professionals judgment, require sharp debridement:

Wound debridement (acute and chronic wounds, burns), Soft tissue debridement and cleansing of surgical sites Device Description The VERSAJET III System consists of a console, foot pedal and a hand piece. There are two hand piece types: VERSAJET III PRECISION Hydrosurgery System Hand Piece for use in the operating room and VERSAJET III PROCLINICAL Hydrosurgery System Hand Piece for the use in the outpatient setting. This device can cut soft tissue. Apply only to tissues and debris intended to be excised from the wound. Warnings and Precautions In order to avoid unwanted procedural delays, ensure the system is fully operational prior to administration of anesthesia. This device should be used with particular care in patients with hemophilia or other blood clotting disorders and in patients receiving anti-coagulant medication. This device can cut soft tissue. Apply only to tissues and debris intended to be excised from the wound. Increasing console power settings will lead to more aggressive tissue removal. Use caution near delicate vessels and structures, such as neurovascular bundles. When used on wounds where bone, tendon or other hard tissue (e.g. leathery eschar) may be encountered during the debridement procedure, excessive spraying and/or misting may occur due to the interruption of the stream of sterile saline by hard tissues. DO NOT touch the high-pressure jet in the operating window of the hand piece. As with all surgical procedures, the VERSAJET III System operator and other clinical personnel should follow the universal precautions for infection control. Examine all components before use. DO NOT use, if you believe a component to be faulty or damaged. Contact your local Smith+Nephew VERSAJET III System representative. DO NOT use if the hand piece packaging seal is broken or the pouch is damaged. Place the console and waste canister onto flat and stable surfaces to prevent the console and waste canister from tilting or falling. DO NOT pull hand piece tubing in an attempt to bring the console closer for use. Select an appropriate waste canister for the procedure. DO NOT connect the waste evacuation tubing hose or any container connected to it, to a vacuum source. DO NOT preheat saline before use the device. Use only sterile saline solution with this device. The VERSAJET III Hydrosurgery System Hand Piece and VERSAJET III Hydrosurgery System Console are not compatible with previous generations of the VERSAJET III console and hand pieces respectively. Each VERSAJET III disposable hand piece is intended for SINGLE-USE ONLY. DO NOT RE-STERILIZE. Device performance will be compromised and sterility cannot be assured. Discard appropriately after use. Refer to our company position regarding the reprocessing and reuse of single-use only medical devices in Appendix A of VERSAJET III Hydrosurgery System User Manual. Special Storage and Handling Instructions Store in a dry place (5 C/41 F-25 C / 77 F). For further information, consult the VERSAJET III Hydrosurgery System User Manual. Instructions for Use It is recommended that prior to clinical use of VERSAJET III System, all operators of the device should be trained in the proper use of VERSAJET III System. Smith+Nephew Representatives will be available to provide a tailored introduction to the use of the system, on the request of the clinician. Contact your local representative for details. 1. Unpack the Hand Piece 1. Remove the pouch from carton. Inspect pouch to ensure seals are intact and pouch is undamaged. Open the pouch, ensuring that the sterility of the inner pouch is not compromised. 2. Aseptically transfer inner pouch and contents to the sterile field (in the operating room) or onto a sterile surface (in an outpatient environment). 3. Aseptically inspect inner pouch to ensure seals are intact and pouch is not damaged. Open inner pouch, remove the sterile contents and place securely in the sterile field or onto a sterile surface. Avoid tangling of the tubing. 4. Remove the hand piece from the clam shell and place in the sterile field or onto a sterile surface. DO NOT remove the orange connector (pump cartridge) from the clam shell tray. 5. Uncoil the tubing lines. DO NOT remove orange bands surrounding the tubing. Maintain aseptic technique for the hand piece and sufficient tubing to allow access to the surgical site. 6. Remove the orange connector from the clam shell and insert the metal end into the connection port on the front of the console. Rotate the connector clockwise to the lock position. Once the connection is achieved, a green tick will appear on the screen. 2. Connect Saline Bag(s) It is recommended that full saline bag(s) are connected prior to commencing with the procedure. CAUTION: Only spike the saline bag(s) once the hand piece has been connected to the console. Failure to do so may result in fluid leakage from the pump cartridge. CAUTION: The system can be operated with either one or two saline bags. If only one bag is required, leave the unused inflow line clamp closed and the bag spike cap on. CAUTION: DO NOT preheat the saline before use. 1. Ensure the inflow line clamp is closed. 2. Remove the sterile cover from the bag spike and insert into the saline supply bag. Repeat for the second bag if necessary. 3. Press the right arrow on the screen to proceed to the next step. NOTE: The saline bag MUST be placed a minimum of 24in / 60 cm above the console. NOTE: To ensure adequate saline supply is selected, consider the power setting to be used for the procedure and procedure length. To calculate the saline volume required, refer to the Flow Rates and Pressures table. 3. Connect waste canister CAUTION: Place the waste canister onto a flat and stable surface to prevent the waste canister from tilting or falling. 1. Attach the waste evacuation tube (blue tip) to the waste canister. CAUTION: DO NOT connect to a port containing a filter or to the VACUUM port. Ensure there is an additional open port on the waste canister lid, to prevent a pressure build-up inside the canister. 2. Ensure there are no kinks or other external obstructions in the tubes. NOTE: The waste canister should be below the level of the hand piece during priming and debriding. CAUTION: To avoid the canister overflowing, ensure the waste canister volume will contain the volume of saline used during the procedure. 3. Press the right arrow on the screen to complete the set-up. CAUTION: Monitor the waste canister and ensure it is emptied to prevent overflowing. 4. Prime the Hand Piece 1. Remove the protective cover from the tip of the hand piece. 2. Initiate the priming sequence on the screen. 3. Power levels will automatically increase from 1 to 10. 4. Open the saline clamps. 5. While holding the hand piece at a safe distance, depress the foot pedal and observe a steady flow of saline at the distal tip of the hand piece. NOTE: A visible saline flow down in the waste tube indicates priming is complete. 6. Release the foot pedal. Indicate that the priming is complete on the screen. NOTE: Once the system has been primed with saline, do not allow the saline bag to empty. An empty bag can cause air to enter the system and require re-priming of the system. 5. Debriding Once priming is complete the system is ready for debridement. To prevent saline splashing back into the eyes, avoid bringing the hand piece tip close to the eyes. CAUTION: This device can cut soft tissue. Apply only to tissues and debris intended to be excised from the wound. NOTE: For optimal results when debriding hard or leathery eschar resulting from burn injuries, it is recommended to first debride the eschar using sharp debridement techniques followed by the use of VERSAJET III System to complete debridement or excision of the wound. 1. To begin debriding, begin at the lowest power setting and increase as necessary. The power setting can be adjusted using the UP and DOWN buttons on the foot pedal, or the +

and buttons on the screen. When the foot pedal is active the + and buttons on the screen will be inactive. WARNING: Increasing console power settings will lead to more aggressive tissue removal. Use caution near delicate vessels, structures and surrounding tissues. WARNING: Empty waste cannister before it is full. 2. While securely holding the hand piece, depress the foot pedal to activate the motor. A constant stream of saline will appear at the distal tip of the hand piece. 3. Position the distal tip over the area requiring debriding. 4. Release foot pedal before removing the hand piece from the wound. NOTE: The VERSAJET III PROCLINICAL Hand Piece has a 20 minutes continuous debridement time limit. The time counter is only active when the foot pedal is depressed and debridement is conducted. Once the 20 minutes are completed, if further debridement is required, a secondhand piece will need to be connected to the console. NOTE: If leaking is observed at the connection interface to the console, replace with a new hand piece. 6. Removal of an obstruction in the evacuation orifice If the evacuation orifice becomes blocked with foreign matter, a reduction in device efficiency or the presence of spray from the instrument tip may result. To remove the obstruction:

1. Remove the hand piece from the wound site 2. Release the foot pedal and remove the obstruction with forceps. NOTE: Avoid touching the opening in the high-pressure jet with forceps. 3. Once the obstruction is removed, depress the foot pedal and check for steady stream of sterile saline flow. 4. If the obstruction is not completely removed, repeat the hand piece set-up and system priming procedure or check that the waste evacuation tube is not pinched by forceps, stepped on or that the collection container is full. 7. Changing the Saline Bag(s) 1. When using one saline bag: If additional saline is required, attach an additional bag to the second line prior to the first bag emptying. Open the second saline line clamp prior to the first bag emptying. When using two bags: Open the second inflow line prior to the first bag emptying. Should additional saline be required for the debridement, ensure the clamp is closed prior to changing the bag. NOTE: Monitor the saline levels during use to ensure the bags are replaced prior to emptying. 8. Replace Hand Piece 1. If a notification appears on the screen with instructions to replace the hand piece, please disconnect the saline bag(s), waste canister, and hand piece from the console. 2. Press OK on the notification and proceed to set up a new hand piece. 9. End of procedure 1. After completing the procedure, disconnect the saline bags, waste canister, hand piece and foot pedal. 2. Discard the hand piece in accordance with your local healthcare facilitys standard guidelines for biohazardous waste disposal. 3. Switch the device off by pressing the power button. 4. Disconnect the power supply cable. Flow Rate and Pressures Values provided in the table are typical values and are provided as guidance only. Actual values may vary. Power Setting VERSAJET III Hand Piece Flow Rate (mL / min) Pressure (psi / bar) 1 2 3 4 5 6 7 8 9 10 82 96 110 123 137 150 167 179 189 197 Glossary of symbols Caution: U.S. Federal law restricts this device to sale by or on the order of a physician Consult instructions for use Do not use if package is damaged Keep dry 1448/100 1962/135 2518/174 3139/216 3856/266 4635/320 5713/394 6549/452 7308/504 7950/548 Do not re-use Caution Sterilized using ethylene oxide Keep Away From Sunlight Temperature limitation Product Availability Part Number Description 66802147 66802148 66802149 66802150 66802151 VERSAJET III PRECISION Hand Piece (15/14mm) VERSAJET III PRECISION Hand Piece (45/14mm) VERSAJET III PRECISION Hand Piece (45/8mm) VERSAJET III PROCLINICAL Hand Piece (45/14mm) VERSAJET III PROCLINICAL Hand Piece (45/8mm) Technical support For further information and troubleshooting guide, consult the VERSAJET III Hydrosurgery System User Manual. Contact Customer Care at 1-800-876-1261 (USA only) or local Smith+Nephew representative. Smith & Nephew Medical Limited, 101 Hessle Road, Hull HU3 2BN England 2022 Smith+Nephew Trademark of Smith+Nephew Certain marks Reg. US Pat. & TM Off. This product may be covered by one or more US Patents. See: www.smith-nephew.com/patents 31230

Smith & Nephew Medical Limited 101 Hessle Road Hull HU3 2BN England T: + 44 (0)1482 225181 F: + 44 (0)1482 328326 www.smith-nephew.com VERSAJET III Label Information and Location Applicant Name: Smith & Nephew Medical Limited Address: 101 Hessle Road, Hull HU3 2BN, United Kingdom Product Name: VERSAJET III Model Number: 66802146 Console Part Number: 121-A2-000508 FCC ID: 2AWH9-VJIII IC ID: 26135-VJIII VERSAJET III Rear View with Device and FCC label location Registered No. 605496 in England and Wales, Registered Office: PO Box 81, 101 Hessle Road, Hull, HU3 2BN Smith & Nephew Medical Limited, acting as agent for T.J.Smith and Nephew,Limited 1 | P a g e Smith & Nephew Medical Limited 101 Hessle Road Hull HU3 2BN England Device Label Artwork with the FCC & IC numbers T: + 44 (0)1482 225181 F: + 44 (0)1482 328326 www.smith-nephew.com Registered No. 605496 in England and Wales, Registered Office: PO Box 81, 101 Hessle Road, Hull, HU3 2BN Smith & Nephew Medical Limited, acting as agent for T.J.Smith and Nephew,Limited 2 | P a g e Smith & Nephew Medical Limited 101 Hessle Road Hull HU3 2BN England VERSAJET III Label Zoom In View T: + 44 (0)1482 225181 F: + 44 (0)1482 328326 www.smith-nephew.com Registered No. 605496 in England and Wales, Registered Office: PO Box 81, 101 Hessle Road, Hull, HU3 2BN Smith & Nephew Medical Limited, acting as agent for T.J.Smith and Nephew,Limited 3 | P a g e

Smith & Nephew Medical Limited 101 Hessle Road Hull HU3 2BN England T: + 44 (0)1482 225181 F: + 44 (0)1482 328326 www.smith-nephew.com Letter of Authorization and Anti- Drug Statement Applicant Name: Smith & Nephew Medical Limited Address: 101 Hessle Road, Hull HU3 2BN, United Kingdom. Product Name: VERSAJET III Model Number: 66802146 FCC ID: 2AWH9-VJIII We authorize:

CETECOM Inc., to act on our behalf on all matters concerning the above named equipment. We declare that CETECOM Inc. is allowed to forward all information related to the approval project to the Federal Communications Commission and discuss any issues concerning the approval application. The applicant must certify that neither the applicant nor any party to the application is subject to a denial of Federal benefits, that include FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862 because of a conviction for possession or distribution of a controlled substance. See 47 CFR 1.2002(b) for the definition of a "party" for these purposes. Does the applicant or authorized agent so certify? Yes I certify that I am authorized to sign this application. All of the statements herein and the exhibits attached hereto, are true and correct to the best of my knowledge and belief. In accepting a Grant of Equipment Authorization as a result of the representations made in this application, the applicant is responsible for (1) labeling the equipment with the exact FCC ID specified in this application, (2) compliance statement labeling pursuant to the applicable rules, and (3) compliance of the equipment with the applicable technical rules. If the applicant is not the actual manufacturer of the equipment, appropriate arrangements have been made with the manufacturer to ensure that production units of this equipment will continue to comply with the FCC's technical requirements. Authorizing an agent to sign this application, is done solely at the applicant's discretion; however, the applicant remains responsible for all statements in this application. If an agent has signed this application on behalf of the applicant, a written letter of authorization which includes information to enable the agent to respond to the above section 5301 (Anti-Drug Abuse) Certification statement has been provided by the applicant. It is understood that the letter of authorization must be submitted to the FCC upon request, and that the FCC reserves the right to contact the applicant directly at any time. Signature of Authorized Person Filing: Felix Quintanar Title: Senior Principal Electrical Engineer Date:

Registered No. 605496 in England and Wales, Registered Office: PO Box 81, 101 Hessle Road, Hull, HU3 2BN Smith & Nephew Medical Limited, acting as agent for T.J.Smith and Nephew,Limited DocuSign Envelope ID: 19A8A9EF-48D1-4C0F-886E-D16C658FAEB628-Feb-2022 | 15:02:23 GMT Certificate Of CompletionEnvelope Id: 19A8A9EF48D14C0F886ED16C658FAEB6Status: CompletedSubject: Please DocuSign: FCC LoA Anti Drug Statement v1.0_VERSAJET III_FCC ID 2AWH9-VJIII.pdfSource Envelope: Document Pages: 1Signatures: 1Envelope Originator: Certificate Pages: 1Initials: 0Felix QuintanarAutoNav: EnabledEnvelopeId Stamping: EnabledTime Zone: (UTC) Dublin, Edinburgh, Lisbon, LondonTJ Smith & Nephew Limited101 Hessle RoadHull, Hull HU3 2BNFelix.Quintanar@smith-nephew.comIP Address: 216.222.214.6 Record TrackingStatus: Original 28-Feb-2022 | 15:00Holder: Felix Quintanar Felix.Quintanar@smith-nephew.comLocation: DocuSignSigner EventsSignatureTimestampFelix Quintanarfelix.quintanar@smith-nephew.comElectrical Engineer 5Smith & NephewSecurity Level: Email, Account Authentication (Required), Login with SSOSignature Adoption: Uploaded Signature ImageSignature ID: F08ED75B-BCC3-42BA-A58C-D137FA2A2BA3Using IP Address: 216.222.214.6With Signing Authentication via DocuSign passwordWith Signing Reasons (on each tab): I approve this documentSent: 28-Feb-2022 | 15:01Viewed: 28-Feb-2022 | 15:01 Signed: 28-Feb-2022 | 15:02Electronic Record and Signature Disclosure: Not Offered via DocuSignIn Person Signer EventsSignatureTimestampEditor Delivery EventsStatusTimestampAgent Delivery EventsStatusTimestampIntermediary Delivery EventsStatusTimestampCertified Delivery EventsStatusTimestampCarbon Copy EventsStatusTimestampWitness EventsSignatureTimestampNotary EventsSignatureTimestampEnvelope Summary EventsStatusTimestampsEnvelope SentHashed/Encrypted28-Feb-2022 | 15:01Certified DeliveredSecurity Checked28-Feb-2022 | 15:01Signing CompleteSecurity Checked28-Feb-2022 | 15:02CompletedSecurity Checked28-Feb-2022 | 15:02Payment EventsStatusTimestamps

Smith & Nephew Medical Limited 101 Hessle Road Hull HU3 2BN England T: + 44 (0)1482 225181 F: + 44 (0)1482 328326 www.smith-nephew.com Federal Communications Commission Equipment Authorization Division 7435 Oakland Mills Road Columbia, MD 21048 Date: 28 of February 2022 Subject:

Request for Short Term Confidentiality FCC-ID: 2AWH9-VJIII To Whom It May Concern:

1. External Photographs 2. Internal Photographs 3. User / Instruction Manual 4. Test Set-up Photographs until the product will be publicly announced. Short term confidentiality release date / period: 180 In accordance with 0.457(d) and 0.459 of CFR 47, Smith & Nephew Medical Limited hereby requests short term confidentiality for documents filed under the following exhibit types:

These items contain detailed system and equipment description and related information about the product which Smith & Nephew Medical Limited considers to be proprietary, confidential and a custom design which otherwise would not be released to the general public. Since this design is a basis from which future technological products will evolve, Smith & Nephew Medical Limited also feels that this information would be of benefit to its competitors, and that the disclosure of the information in these exhibits would give our competitors an unfair advantage in the market. We are informed and aware of our obligation that we have to inform the involved TCB in written and in due time if we intend to market the product prior to the above specified confidentiality release date so that the short term confidentiality classification can be reset prior to product launch. We are aware that exhibit types cover letters, attestations, label document, test reports, RF exposure information (SAR and MPE reports), cannot be requested to be classified confidential and are thus subject to publication, as will be documents of all other exhibits types for which we have not requested a confidentiality classification. Best Regards, ____________________________________ Signature Name: Felix Quintanar Title: Senior Principal Electrical Engineer Company Name: Smith & Nephew Medical Limited Address: 101 Hessle Road, Hull HU3 2BN. United Kingdom Registered No. 605496 in England and Wales, Registered Office: PO Box 81, 101 Hessle Road, Hull, HU3 2BN Smith & Nephew Medical Limited, acting as agent for T.J.Smith and Nephew,Limited DocuSign Envelope ID: F0353B44-1D01-4BA0-84F5-395A2FE5C9C0 Certificate Of CompletionEnvelope Id: F0353B441D014BA084F5395A2FE5C9C0Status: CompletedSubject: Please DocuSign: FCC Short Term Confidentiality Request_VERSAJET III_FCC ID 2AWH9-VJIII .pdfSource Envelope: Document Pages: 1Signatures: 1Envelope Originator: Certificate Pages: 1Initials: 0Felix QuintanarAutoNav: EnabledEnvelopeId Stamping: EnabledTime Zone: (UTC) Dublin, Edinburgh, Lisbon, LondonTJ Smith & Nephew Limited101 Hessle RoadHull, Hull HU3 2BNFelix.Quintanar@smith-nephew.comIP Address: 216.222.214.6 Record TrackingStatus: Original 28-Feb-2022 | 15:06Holder: Felix Quintanar Felix.Quintanar@smith-nephew.comLocation: DocuSignSigner EventsSignatureTimestampFelix Quintanarfelix.quintanar@smith-nephew.comElectrical Engineer 5Smith & NephewSecurity Level: Email, Account Authentication (Required), Login with SSOSignature Adoption: Uploaded Signature ImageSignature ID: F08ED75B-BCC3-42BA-A58C-D137FA2A2BA3Using IP Address: 216.222.214.6With Signing Authentication via DocuSign passwordWith Signing Reasons (on each tab): I approve this documentSent: 28-Feb-2022 | 15:07Viewed: 28-Feb-2022 | 15:07 Signed: 28-Feb-2022 | 15:08Electronic Record and Signature Disclosure: Not Offered via DocuSignIn Person Signer EventsSignatureTimestampEditor Delivery EventsStatusTimestampAgent Delivery EventsStatusTimestampIntermediary Delivery EventsStatusTimestampCertified Delivery EventsStatusTimestampCarbon Copy EventsStatusTimestampWitness EventsSignatureTimestampNotary EventsSignatureTimestampEnvelope Summary EventsStatusTimestampsEnvelope SentHashed/Encrypted28-Feb-2022 | 15:07Certified DeliveredSecurity Checked28-Feb-2022 | 15:07Signing CompleteSecurity Checked28-Feb-2022 | 15:08CompletedSecurity Checked28-Feb-2022 | 15:08Payment EventsStatusTimestamps