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VERSAJET™HYDROSURGERYSYSTEM

*smith&nephew

VERSAJET™ Hydrosurgery System

Contents

PRESCRIPTION INFORMATION ................................................ 4

PRODUCT DESCRIPTION ........................................................ 5Overview of the VERSAJET™ Hydrosurgery SystemSystem ComponentsPower ConsoleDisposable Handpiece Assembly with Pump CartridgeFoot SwitchPower CordSystem Specifications

SYSTEM SET-UP ..................................................................... 9Set-up of the ConsoleSet-up of the Disposable Handpiece Assembly with Pump Cartridge

SYSTEM SET-UP ..................................................................... 10Maintaining the Power ConsoleCleaning the Power ConsoleReplacing the Power CordReplacing the Foot Switch

TROUBLESHOOTING .............................................................. 11

EQUIPMENT CLASSIFICATION AND SYMBOLS ........................ 12

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Product Manual

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PRESCRIPTION INFORMATION

Device IndicationsCE Mark: The VERSAJET™ Hydrosurgery System is intended to cut, ablate and remove tissue from wounds and to resect andremove material in various surgical procedures including wound debridement.

In the USA: The VERSAJET™ Hydrosurgery System is intended for wound debridement, soft tissue debridement, and cleansingof the surgical site in applications that, in the surgeon’s judgment, would require the use of a pulse lavage device with sharpdebridement. 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.

Warnings1. 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.

Precautions1. 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.

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PRODUCT DESCRIPTION

Overview of the VERSAJET™ Hydrosurgery SystemThe VERSAJET™ Hydrosurgery System utilizes a small fluidjet to create a surgical instrument that combines the benefits ofsharp debridement and pulsed lavage. The high-pressure fluidjet is aimed directly into an open tube called the evacuationtube. The unique design of the evacuation tube and its proximity to the fluidjet creates a localized vacuum that efficientlyremoves debris, tissue, or fluids. By simply placing the instrument tip near a piece of debris, it can easily be removed fromthe wound via the inherent vacuum of the fluidjet. However, the fluidjet itself is designed to provide sufficient pressure to cutthrough 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 surgicalneeds for wound debridement, including foreign material removal, tissue excision, and wound site shaping.

System ComponentsThe VERSAJET™ Hydrosurgery System contains three basic components: the Disposable Handpiece Assembly, the PowerConsole, and the Foot Switch. The handpiece assembly consists of the Handpiece itself, a Pump Cartridge, and hoses. ThePump Cartridge mounts onto a clamp assembly on the front of the Power Console; this connection provides the power to theDisposable Handpiece Assembly. The Foot Switch provides remote actuation of the Power Console.

The system is designed to work with any Disposable VERSAJET™ Handpiece Assembly.

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Power ConsoleFront 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 theoff (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 speedlevel 1, the lowest pressure level for the system. The up and down arrows that are immediately adjacent to the digital displaycan be used to increase or decrease the speed respectively.

Three indicator lights are located to the left of the digital display.

Rear Panel

“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 onlybe cleared by toggling the power switch off and on.

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Disposable Handpiece Assembly with Pump CartridgeThe Disposable Handpiece Assembly consists of two main components: the handpiece itself and a pump cartridge topressurise 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 carriesthe pressurised fluid from the cartridge to the handpiece. Finally, the waste hose carries the saline solution and any materialcollected 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 theend of the high-pressure tube is a small, precise opening which regulates the size and flow of the fluidjet. The end of theevacuation tube is specifically designed to generate an appropriate vacuum for removal of material while still allowing thesurgeon to visualize the wound being debrided. It also allows the fluidjet to contact tissues and material that should be cutor 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 thepump cartridge, where it is pressurised, and then to the handpiece for use at the surgical site. It also ensures removal oftissue debris from the instrument tip into an appropriate waste container.

Foot Switch with ConnectorThe Foot Switch is connected to the Power Console through the receptacle on the front panel. It allows the surgeon to activatethe instrument while working in the sterile surgical field. A missing or poorly connected Foot Switch is indicated when the“pedal” light is illuminated.

Power CordThe Power Cord provides electrical power to the console from a wall socket.

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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 ReceptacleSpeed Control for levels 1 through 10Amber “Door” indicator LightAmber “Pedal” indicator LightRed “Error” indicator Light

Rear Panel: Power Cord ReceptaclePower 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.

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%, noncondensingAtmospheric 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%, noncondensingAtmospheric Pressure: 500 to 1500 millibar

ELECTROMAGNETIC INTERFERENCE RISK

The power console has been tested according to IEC 60601-1-2 (2001-09)

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SYSTEM SET-UPThis chapter provides the procedures for assembling and testing the VERSAJET™ Hydrosurgery System.

Set-up of the Console1. 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 Cartridge1. 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 cartridgenest. 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 electricaloutlet. 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 theclamp 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 afteruse.

Contact a Smith & Nephew representative to order additional Disposable Handpiece Assembly with Pump Cartridge.

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MAINTAINING THE POWER CONSOLEThere 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 foreignmaterial. 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 ofdust 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 soakedin 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 ConsoleDisconnect from electrical power source. Wipe down console and foot switch with a clean, damp cloth. Household all-purposecleaners 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 CordIf the power cord is damaged, it can be removed from the Power Console. FIRST, REMOVE THE PLUG FROM THE WALLSOCKET. 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 SwitchIf the foot switch is damaged, it should be removed from the Power Console. Contact a Smith & Nephew representative toorder a replacement foot switch.

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TROUBLESHOOTING

Excessive spray

Motor is turning, but nofluidjet is visible inhandpiece

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

SYMPTOM CAUSE REMEDY

Obstruction of evacuation tube(grit, stick, wire, or other foreignmaterial)

Misaligned jet (striking edge oftube or shooting outsideinstrument)

Waste hose is not drainingproperly

Waste hose is:ObstructedKinkedPinched

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 fullyclosed

Over-current situation hasoccurred (unknown cause)

Over-current situation with arigid high pressure hose.Handpiece high pressure hoseis plugged

Remove handpiece from surgical field and take footoff foot pedal and remove obstruction frominstrument tip

Stop!Do not useReplace handpiece

Raise waste hose so collector end of waste hose islowest point of entire tube

Remove obstructionUnkink hoseRemove object causing pinch

Attach saline bag or replace saline bag if empty

Pump fluid on high setting until system is purged ofall air in supply hose

Assure power cord is attached to back of consoleand wall outlet

Turn on

Attach foot switch securely

Replace foot switch

Completely close cartridge clamp

Turn off main power switch, wait 5 seconds, turnback power back on

Discard handpiece assembly and replace with a newunit