smith&nephew VERSAJET II EXACT Mode D'emploi page 2

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VERSAJET™ II EXACT
VERSAJET™ II PLUS
Hydrosurgery System Handpieces
Do not use contents if package is opened or damaged.
Single use Handpiece Assembly — Do not re-sterilize.
Indications for Use
The VERSAJET II Hydrosurgery System is intended for wound
debridement (acute and chronic wounds, burns), soft tissue
debridement, and cleansing of the surgical site in applications that,
in the physician's judgment, require sharp debridement and/or
pulsed lavage irrigation.
Device Description
Producing a high-pressure stream of sterile saline, the VERSAJET II
Hydrosurgery System creates a localized vacuum in the operating
window of the handpiece.
As the handpiece tip is applied parallel/tangential to the wound
surface, various tissue types can be targeted for debridement. The
design of the handpiece allows precise removal of tissue on large
areas and irregular, contoured surfaces such as web spaces and
facial structures.
Warnings
• This device should be used with particular care in patients with
hemophilia or other blood clotting disorders and in patients receiv-
ing anti-coagulant medication.
• VERSAJET II EXACT and PLUS handpieces are designed for
connection only to the VERSAJET II Hydrosurgery System power
console (part number (p/n) 66800039).
• Increasing settings on the device console will lead to more ag-
gressive tissue removal. Use caution near sensitive tissue, such as
neurovascular bundles.
• This device can cut soft tissue. Apply only to tissue intended to
be cut or to remove debris from the wound.
• VERSAJET II is intended primarily for use in the operating room
environment. Only 45º VERSAJET II EXACT handpieces
(p/n 66800041 and 66800042) are suitable for use outside the
operating room. Attention to universal infection control procedures
should be applied when using the device outside the controlled
environment of the operating room.
• If VERSAJET II EXACT 45º handpieces are used outside the
operating room, ensure the floor immediately surrounding the
treatment area is covered and any splashes cleaned after treat-
ment is complete.
• The 15º/14mm VERSAJET II EXACT handpiece (p/n 66800040)
and all VERSAJET II PLUS handpieces (p/n 66800043,
66800044 and 66800045) should not be used outside the
operating room due to potential excessive misting and/or
spraying.
• VERSAJET II PLUS handpieces provide more aggressive
debridement and excision when compared to VERSAJET II EXACT
handpieces. VERSAJET II PLUS is appropriate for wounds that re-
quire aggressive, yet selective, removal of tissue that are tough,
heavily necrotic, contaminated or burnt. Users should be aware
that just as with any sharp instrument, care and attention must
be maintained while using VERSAJET II PLUS handpieces near
fragile or sensitive structures.
Precautions
• Always begin debridement procedures at lower power settings
and increase as necessary to the optimal power setting for the type
of tissue being debrided and to avoid unintended tissue removal.
• In order to avoid unwanted procedural delays, ensure the system
is fully operational prior to administration of anesthesia.
• When used on wounds where bone, tendon or other dense
tissue may be encountered during the debridement procedure,
excessive spraying and/or misting may occur due to the interrup-
tion of the stream of sterile saline by hard tissue.
• Spraying and/or misting is more frequent at lower power settings
due to less pressure. Spraying and/or misting may be reduced by
keeping the waste evacuation tube straight.
• As with all surgical procedures, the VERSAJET II operator and
clinical personnel should follow universal precautions for infection
control (including the use of surgical gloves, facemask that covers
the mouth and nose, protective eye goggles, protective clothing,
and anti-slip shoe covers).
• 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 II to complete debridement or excision of the wound.
• It is recommended that prior to clinical use of VERSAJET II devices
and handpieces, all operators should be trained in the proper use.
Smith & Nephew has developed a training program. Contact your
local market representative for details concerning
VERSAJET II training.
• Do not add antibiotics, medication or other fluids to the saline irri-
gation source. Additives may change fluid dynamics and negatively
affect product performance.
• Do not allow saline bag to empty; this could allow air to enter the
supply tube. Air in the supply tube will temporarily lower device
efficiency and may require re-priming of the system.
• Connecting the waste evacuation tubing hose (or any container
connected to it) to a vacuum source is not recommended and may
increase the aggressiveness of tissue removal.
• Monitor fluid level of waste container and empty as needed.
• Subsequent debridement procedures may be necessary for
complex or highly contaminated wounds.
• Do not touch the high pressure jet in the operating window of the
handpiece.
• Use only sterile saline solution with this device.
• Examine all components before use. If you believe a component
to be faulty, damaged, or suspect, DO NOT USE. Contact your local
Smith & Nephew VERSAJET II representative.
• Each VERSAJET II disposable handpiece is intended for SINGLE
USE ONLY. DO NOT RE-STERILIZE. Discard after use. VERSAJET II
handpieces are not designed to withstand the rigors of reprocess-
ing or re-sterilization; device performance will be compromised
and sterility can not be assured. Refer to our company position in
the VERSAJET II Hydrosurgery System User Manual or visit our web
site: www. v ersajet.info
• Pre-heating saline prior to use with VERSAJET II is not recom-
mended. Due to the use of high pressure, some heating of the
saline will occur during use.
Special Storage and Handling Instructions
Do not store product above 125°F (52°C) or below -40°F (-40°C).
For further information, consult the VERSAJET II Hydrosurgery
System User Manual.
Instructions for Use
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.
Note: Chart labels are on the outer pouch.
2. 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. Avoid tangling and knotting of hoses.
3. Remove white handpiece from plastic tray and place in sterile
field. Do not remove pump cartridge (orange handle) from clam
shell tray.
4. Remove the white paper tape from coiled tubing. Uncoil the vari-
ous tubing lines. Maintain aseptic technique for the white handle
portion of the handset and several feet of tubing to allow access
to the surgical site. Hand off the saline spike line, orange pump
cartridge assembly in clam shell tray and clear evacuation line to
the Circulator for final system set up.
5. The Circulator should remove the orange pump cartridge from
the clam shell and insert into the handpiece connection port
located on the front of the console until fully seated and then turn
clockwise to the 3 o'clock position. When locked correctly, the cir-
cular light surrounding the connection port should illuminate green.
6. CAUTION: Only insert the saline bag spike AFTER the orange
pump cartridge has been securely locked in the console. Failure to
do so may result in fluid leakage from the pump cartridge.
7. Remove sterile cover from bag spike and insert into sterile saline
supply bag. Ensure that the clip on the saline inflow line is open.
8. Attach end of waste evacuation tubing (blue tip) to waste con-
tainer. DO NOT connect to a port containing a filter or to the port
labeled "VACUUM". You must ensure that there is an additional
open port on the waste containers lid. Ensure there are no kinks
or other external obstructions in saline supply, high-pressure and
waste evacuation hoses.
9. Insert the foot pedal cable into the connector on the front of
the console until the cable locks in place. The red dot on the plug
should be aligned with the red dot on the console. Position the foot
pedal for convenient access.
10. Insert the female three-prong plug of the power cord into the
back of the console and the other end into an electrical outlet.
Press the main power switch located on the front of the console.
11. Remove the protective cover from the tip of handpiece.
12. While keeping the handpiece at a safe distance, set the console
power setting to 10. Press the foot pedal and keep the system run-
ning until saline reaches the distal tip of the handpiece. An audible
hissing sound and a visible saline jet aimed down the evacuation
line, indicates the system is primed. Priming takes approximately
30 seconds. Release the foot pedal and reduce the power setting
to 1 before use.
*smith&nephew
Caution: U.S. Federal law restricts this device
to sale by or on the order of a physician
Sterilized using
ethylene oxide
Do not
LATEX
reuse
13. 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. Tubing
should be clamped when changing saline bags.
14. Begin debridement procedures starting at the lowest power
setting and increase as necessary to the optimal power setting for
the type of tissue being excised or debrided.
15. If the device tip becomes blocked with foreign matter, a reduc-
tion in device efficiency or the presence of spray from the tip may
result. To eliminate the obstruction, remove the handpiece from the
wound site, release the foot pedal and remove the obstruction with
forceps. Do not touch the opening in the high-pressure jet with
forceps. Once the obstruction is removed, press the foot pedal and
check for steady stream of sterile saline flow. If the obstruction is
not completely removed, repeat procedure or check that the evacu-
ation line is not pinched by forceps or being stepped on, or that the
collection container is full.
16. After completing the procedure, turn off the console main power
switch. Disconnect the handpiece assembly from the power console
by turning the orange pump assembly counterclockwise to the 12
o'clock position. Remove the pump cartridge by pulling it straight out.
Discard handpiece assembly in accordance with your healthcare
facility's standard guidelines for biohazardous waste disposal.
17. Follow your healthcare facility standard procedures for decon-
taminating surgical equipment. The following are the manufac-
turer's recommendations for console decontamination: Wipe all
surfaces of the console with paper towels or a cloth soaked in a
disinfectant solution. Sporicidin® Disinfectant (1.12% glutaralde-
hyde 1.93% phenol/phenate) or an equivalent high-level disinfec-
tant is recommended. Dilute the disinfectant solution according to
the manufacturer's instructions. After disconnecting the foot pedal
and power cable from the power source, wipe down all exposed
surfaces of both components in accordance with the guidance for
the console. Dispose of towels, gloves and gown in accordance
with your healthcare facility's standard guidelines for biohazardous
waste disposal.
Product Availability
Part Number Size
66800040 VERSAJET II EXACT 15°/14mm
66800041 VERSAJET II EXACT 45°/14mm
66800042 VERSAJET II EXACT 45°/8mm
66800043 VERSAJET II PLUS 15°/14mm
66800044 VERSAJET II PLUS 45°/14mm
66800045 VERSAJET II PLUS 45°/8mm
Operating Characteristics
Values provided in the table are typical values and are provided as
guidance only. Actual values may vary.
Fluidjet VERSAJET II VERSAJET II
EXACT EXACT
Flow
Power
Fluid Fluidjet
Setting
Rate
Pressure Velocity
mL/min psi/bar mph/kph
1 90 1787/123 333/536
2 109 2789/192 396/637
3 123 3799/262 447/719
4 138 4816/332 501/807
5 160 5924/408 590/949
6 166 7080/488 603/971
7 181 8180/564 658/1058
8 195 9297/641 709/1140
9 209 10421/719 759/1222
10 220 11535/795 810/1304
Technical Assistance
Contact your local market representative for technical assistance.
In North America, contact Technical Support
1-800-343-5717.
Do not use if pack-
ge is damaged
This product does not contain
natural rubber latex
VERSAJET II VERSAJET II
PLUS PLUS
Fluid Fluidjet
Pressure Velocity
psi/bar mph/kph
2100/145 414/666
3100/214 501/806
4300/297 567/912
5500/379 632/1018
6700/462 736/1184
7900/545 764/1230
9200/634 830/1336
10400/717 896/1443
11700/807 962/1549
12800/883 1012/1628