*smith&nephew VERSAJET HYDROSURGERY SYSTEM

Product Manual Manuel D utilisation Bedienungshandbuch Manual Del Producto Manuale Prodotto Producthandleiding *smith&nephew VERSAJET HYDROSURGERY SYSTEM

VERSAJET Hydrosurgery System Product Manual Contents PRESCRIPTION INFORMATION... 4 PRODUCT DESCRIPTION... 5 Overview of the VERSAJET Hydrosurgery System System Components Power Console Disposable Handpiece Assembly with Pump Cartridge Foot Switch Power Cord System Specifications SYSTEM SET-UP... 9 Set-up of the Console Set-up of the Disposable Handpiece Assembly with Pump Cartridge SYSTEM SET-UP... 10 Maintaining the Power Console Cleaning the Power Console Replacing the Power Cord Replacing the Foot Switch TROUBLESHOOTING... 11 EQUIPMENT CLASSIFICATION AND SYMBOLS... 12 3

PRESCRIPTION INFORMATION Device Indications CE Mark: The VERSAJET Hydrosurgery System is intended to cut, ablate and remove tissue from wounds and to resect and remove material in various surgical procedures including wound debridement. In the USA: The VERSAJET Hydrosurgery System is intended for wound debridement, soft tissue debridement, and cleansing of the surgical site in applications that, in the surgeon s judgment, would require the use of a pulse lavage device with sharp debridement. This device is not intended to be used on burns. In Canada: The VERSAJET Hydrosurgery System is intended for the cutting, resection and removal of tissue, contaminants, or fluids from the wound or surgical site. Warnings 1. This device should be used with particular care in patients with hemophilia. 2. Only VERSAJET approved equipment should be connected to this device. 3. Use of the higher settings on the device console will lead to more aggressive tissue removal. Use caution near sensitive tissues, such as neurovascular bundles. 4. This device can cut soft tissue. Precautions 1. Use lower settings on the device console for deep wounds where visualization is obscured. 2. Do not allow saline bag to empty because this could allow air to enter the supply tube. Air in the supply tube will result in temporary lower device efficiency and require re-priming of the system. 3. Subsequent debridement procedures may be necessary. 4. Use only sterile saline solution with this device. 5. Examine all components before use. If you believe a component to be faulty, damaged, or suspect, DO NOT USE. 6. Each Disposable Handpiece is intended for SINGLE USE ONLY. Do not resterilize. Discard after use. 7. Do not connect the waste hose, or any container connected to it, to a vacuum source. USA law restricts this device to sale by or on the order of a physician. 4

PRODUCT DESCRIPTION Overview of the VERSAJET Hydrosurgery System The VERSAJET Hydrosurgery System utilizes a small fluidjet to create a surgical instrument that combines the benefits of sharp debridement and pulsed lavage. The high-pressure fluidjet is aimed directly into an open tube called the evacuation tube. The unique design of the evacuation tube and its proximity to the fluidjet creates a localized vacuum that efficiently removes debris, tissue, or fluids. By simply placing the instrument tip near a piece of debris, it can easily be removed from the wound via the inherent vacuum of the fluidjet. However, the fluidjet itself is designed to provide sufficient pressure to cut through human tissues such as skin, muscle, and cartilage. Thus, by moving the fluidjet into contact with compromised tissue, the fluidjet will easily cut tissue and suction it away from the wound. The VERSAJET Hydrosurgery System allows a surgeon to select the operating technique that meets the patient s surgical needs for wound debridement, including foreign material removal, tissue excision, and wound site shaping. System Components The VERSAJET Hydrosurgery System contains three basic components: the Disposable Handpiece Assembly, the Power Console, and the Foot Switch. The handpiece assembly consists of the Handpiece itself, a Pump Cartridge, and hoses. The Pump Cartridge mounts onto a clamp assembly on the front of the Power Console; this connection provides the power to the Disposable Handpiece Assembly. The Foot Switch provides remote actuation of the Power Console. The system is designed to work with any Disposable VERSAJET Handpiece Assembly. 5

Power Console Front Panel The Power Switch is on the lower left corner of the front panel. When the system is not in use, this switch should be in the off (O) position. The Foot Switch Receptacle receives the cable connector from the external Foot Switch to allow remote operation of the system. The Foot Switch is the only means of actuating the device. It allows for direct surgeon control over console activation. The digital display, located to the left of the up and down-speed control arrows on the centre of the panel, defaults to speed level 1, the lowest pressure level for the system. The up and down arrows that are immediately adjacent to the digital display can be used to increase or decrease the speed respectively. Three indicator lights are located to the left of the digital display. Door When illuminated, an amber Door light indicates that the console knob is not completely closed. Pedal When illuminated, an amber Pedal light indicates that the foot switch is not properly connected. Error When illuminated, a red Error light indicates that an over-pressure condition has occurred that can only be cleared by toggling the power switch off and on. Rear Panel 6

Disposable Handpiece Assembly with Pump Cartridge The Disposable Handpiece Assembly consists of two main components: the handpiece itself and a pump cartridge to pressurise the fluid. In addition to these main components, there are three hoses pre-assembled and included in the system. A bag spike hose allows the fluid from a sterile saline bag to enter the pump cartridge. A high-pressure hose then carries the pressurised fluid from the cartridge to the handpiece. Finally, the waste hose carries the saline solution and any material collected at the instrument tip from the handpiece to an appropriate waste container. The handpiece consists of an ergonomic handle, a small diameter high-pressure tube, and a larger evacuation tube. Near the end of the high-pressure tube is a small, precise opening which regulates the size and flow of the fluidjet. The end of the evacuation tube is specifically designed to generate an appropriate vacuum for removal of material while still allowing the surgeon to visualize the wound being debrided. It also allows the fluidjet to contact tissues and material that should be cut or ablated. No external vacuum source is required. In summary, the Disposable Handpiece Assembly controls the flow of sterile saline from the fluid supply bag through the pump cartridge, where it is pressurised, and then to the handpiece for use at the surgical site. It also ensures removal of tissue debris from the instrument tip into an appropriate waste container. Foot Switch with Connector The Foot Switch is connected to the Power Console through the receptacle on the front panel. It allows the surgeon to activate the instrument while working in the sterile surgical field. A missing or poorly connected Foot Switch is indicated when the pedal light is illuminated. Power Cord The Power Cord provides electrical power to the console from a wall socket. 7

SYSTEM SPECIFICATIONS CAUTION Only VERSAJET approved equipment should be connected to this device. CONSOLE Front Panel: Illuminated Power Switch, On/Off (1/0) Foot Switch Receptacle Speed Control for levels 1 through 10 Amber Door indicator Light Amber Pedal indicator Light Red Error indicator Light Rear Panel: Power Cord Receptacle Power Console: AC Power: Detachable power cord with a Hospital Grade connector 100-120 V / 200-240 V ~ 6A / 3A 50/60 Hz Prior to connecting the device to an electrical mains outlet, determine local voltage and electrical supply requirements. Ensure the cable is compatible. 115 230 Depress voltage switch toward direction indicated, 115V (100-120) or 230V (200-240) Size: 18 W x 13 D x 8 H (45.7 cm W x 33.0 cm D x 20.3 cm H) Weight: 28 pounds (12.7 kg) FOOT SWITCH Size: 3 W x 9 D x 2.5 H (7.6 cm W x 22.9 cm D x 6.4 cm H) Weight: 3 pounds (1.12 kg) POWER CORD Length: 15 feet (4.5 m) DISPOSABLE HANDPIECE ENVIRONMENTAL CONDITIONS Unless otherwise stated, the following conditions apply for product use as well as shipping and handling: Temperature Range (Shipping & Handling): -40 F (-40 C) to 125 F (52 C) Temperature Range (Product Use): 40 F (4 C) to 100 F (38 C) Humidity Range: 0% to 100%, noncondensing Atmospheric Pressure: 500 to 1500 millibar POWER CONSOLE ENVIRONMENTAL CONDITIONS Unless otherwise stated, the following conditions apply for product use as well as shipping and handling: Temperature Range (Shipping & Handling): -4 F (-20 C) to 131 F (55 C) Temperature Range (Product Use): 40 F (4 C) to 100 F (38 C) Humidity Range: 0% to 100%, noncondensing Atmospheric Pressure: 500 to 1500 millibar ELECTROMAGNETIC INTERFERENCE RISK The power console has been tested according to IEC 60601-1-2 (2001-09) 8

SYSTEM SET-UP This chapter provides the procedures for assembling and testing the VERSAJET Hydrosurgery System. Set-up of the Console 1. Connect the Foot Switch Cord to the receptacle on the front of the Power Console. 2. Connect the Power Cord to the back of the console and to an appropriate outlet. Set-up of the Disposable Handpiece Assembly with Pump Cartridge 1. Circulating Nurse: Open outer bag, ensure that the sterility of the inner bag is not violated and transfer contents to the sterile table. 2. Scrub Nurse: Open inner bag and remove contents. Remove pump cartridge (with coiled bag spike hose attached) from packaging. Uncoil high-pressure hose. Hand the pump cartridge and coiled bag spike hose to Circulating Nurse. 3. Circulating Nurse: Turn console knob counterclockwise to the 4:00 position. Insert the pump cartridge into the cartridge nest. When in the proper orientation, the high-pressure hose is directly above the clear supply hose. Push the cartridge in until the handle contacts the front surface. Turn console knob clockwise to the 6:00 position and verify the door light turns off. Remove sterile cover from bag spike and insert into sterile fluid supply bag. Use saline bags that have a capacity of at least three (3) litres. 4. Scrub Nurse: Remove clear exhaust hose from packaging. Hand end of exhaust hose to Circulating Nurse. 5. Circulating Nurse: Attach end of exhaust hose to waste container. Ensure there are no kinks or other external obstructions in saline supply, high pressure and exhaust hoses. 6. Circulating Nurse: Plug one end of the power cord into the back of the console and the other end into a proper electrical outlet. Turn on the main power switch. Make sure the foot switch is plugged into the connector on the front of the console and verify that the foot switch light is not illuminated. 7. Scrub Nurse: Remove the handpiece from the packaging. While holding the handpiece, depress the foot switch for several seconds to prime the system. The VERSAJET handpiece will create a hissing sound at the tip of the instrument with a visible fluidjet aimed down the evacuation tube once primed. 8. Nursing Staff: Once the system has been primed with saline, do not allow the saline bag to empty; an empty bag will allow air into the system, reduce the device s system s efficiency, and require re-priming the system. Therefore, always change to a new saline bag before the bag in use empties. Take care when switching bags to prevent air from entering system by closing off the saline spike hose with the pinch clamp. 9. If the device tip becomes blocked with foreign matter, it will typically be noticed by a reduction in device efficiency or the presence of spray from the tip. Remove the handpiece from the wound site. Stop the jet flow by releasing the foot switch. Remove the obstruction with forceps taking care not to touch the opening in the high-pressure jet. Once removed, depress the foot switch and check that there is a single coherent jet flow. If the obstruction is not completely removed, repeat procedure. 10. After completing debridement, disconnect the VERSAJET Disposable Assembly from the power console by opening the clamp handle and removing the pump cartridge by pulling it straight out. Discard assembly. CAUTION Each Disposable Handpiece is intended for SINGLE USE ONLY. Do not resterilize. Discard after use. Contact a Smith & Nephew representative to order additional Disposable Handpiece Assembly with Pump Cartridge. 9

MAINTAINING THE POWER CONSOLE There are no user serviceable parts within the console, however there are several maintenance items to be observed. CAUTION Unplug the unit before starting any maintenance on the console. The fan slots should be kept free from obstructions and periodically be inspected for excessive build-up of dust and/or foreign material. A vacuum cleaner should be used to clean the fan slots of any loose debris. The slots on the bottom of the console should be kept free from obstructions and be periodically inspected for build up of dust and/or foreign material. A vacuum cleaner should be used to clean the slots of any loose debris. The inside of the console clamp should be inspected periodically for build-up of deposits and/or debris. A damp cloth soaked in mild detergent can be used to remove material. Do not soak the inside of the clamp. Excessive fluid could cause damage. At the end of the console s useful life, dispose of the console according to local regulations. Cleaning the Power Console Disconnect from electrical power source. Wipe down console and foot switch with a clean, damp cloth. Household all-purpose cleaners can be used to clean all surfaces. DO NOT IMMERSE. Do not sterilize or immerse in disinfectant solution. CAUTION Do not sterilize or immerse the Power Console or the Foot Switch. Replacing the Power Cord If the power cord is damaged, it can be removed from the Power Console. FIRST, REMOVE THE PLUG FROM THE WALL SOCKET. Do not pull on the cord itself. Remove plug from console, again without pulling on the cord. Contact a Smith & Nephew representative to order a replacement power cord. Replacing the Foot Switch If the foot switch is damaged, it should be removed from the Power Console. Contact a Smith & Nephew representative to order a replacement foot switch. 10

TROUBLESHOOTING SYMPTOM CAUSE REMEDY Excessive spray Motor is turning, but no fluidjet is visible in handpiece Motor does not run, Switch light is off Motor does not run, Switch light is on, Pedal light is on Motor does not run, Switch light is on, Door light is on Motor does not run, Switch light is on, Error light is on Obstruction of evacuation tube (grit, stick, wire, or other foreign material) Misaligned jet (striking edge of tube or shooting outside instrument) Waste hose is not draining properly Waste hose is: Obstructed Kinked Pinched No fluid supply Air in supply hose Power cord not attached Power switch in off position Foot switch not attached Foot switch is damaged Cartridge clamp is not fully closed Over-current situation has occurred (unknown cause) Over-current situation with a rigid high pressure hose. Handpiece high pressure hose is plugged Remove handpiece from surgical field and take foot off foot pedal and remove obstruction from instrument tip Stop! Do not use Replace handpiece Raise waste hose so collector end of waste hose is lowest point of entire tube Remove obstruction Unkink hose Remove object causing pinch Attach saline bag or replace saline bag if empty Pump fluid on high setting until system is purged of all air in supply hose Assure power cord is attached to back of console and wall outlet Turn on Attach foot switch securely Replace foot switch Completely close cartridge clamp Turn off main power switch, wait 5 seconds, turn back power back on Discard handpiece assembly and replace with a new unit 11