Smith & Nephew VERSAJET User manual

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

VERSAJET™ Hydrosurgery System
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
ENG
3
Product Manual

4
ENG
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.

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ENG
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.

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ENG
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.
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 only
be cleared by toggling the power switch off and on.

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ENG
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.

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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 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.
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)
115
230

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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.

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ENG
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.

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ENG
TROUBLESHOOTING
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
SYMPTOM CAUSE REMEDY
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