Smith & Nephew VERSAJET III User manual

BRAND VERSAJET™ III
DATE 12.04.2022 REVISION 17
COMPONENT User Manual
THIS BSC/REF 30958
N/A
A5 (24pp)
PRODUCT Hydrosurgery System
SKU N/A
COLOURS
Match to
coated stock
PMS
Black
Pantone 1375 C (Cover only)
CMY (Pages 6, 14 & 16 only)
JOB NUMBER S38163 - 6389
ARTWORK MP CHECKED ARN
PREV BSC/REF
DIMENSIONS

VERSAJET◊III
Hydrosurgery System
User Manual

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Table of Contents
1. Description 4
2. Indications for Use 4
3. Safety 4
4. Contraindications 4
5. Warnings and Precautions 4
6. System components 5
6.1 Console 5
6.1.1 Front panel layout 5
6.1.2 Side panel 5
6.1.3 Rear panel layout 6
6.2 Foot pedal 6
6.3 Single-Use Hand Piece 7
6.3.1 Hand Piece Options 8
7. Instructions for Use 9
7.1 System set-up 9
7.2 Placement of the console 9
7.3 Power cord socket 9
7.4 Turning the console ON 9
7.5 Setting up the Device 9
7.5.1 Connect the foot pedal 9
7.5.2 Connect the Hand Piece 9
7.5.3 Connect the Saline Bag(s) 10
7.5.4 Connect the Waste Canister 10
7.6 Prime the Hand Piece 10
7.7 Debriding 10
7.8 Removal of an obstruction in the evacuation orifice 11
7.9 Changing the Saline Bag(s) 11
7.10 Replace Hand Piece 11
7.11 End of procedure 11
7.12 Hand piece quick set-up pictorial guide 12
8. Console cleaning and maintenance 13
8.1 Cleaning 13
8.2 Maintenance 13
9. Disposal of the console and accessories 13
10. Troubleshooting Guide 14
11. Glossary of symbols 16
12. Technical information 16
13. System specifications 17
14. Environmental Conditions 17
15. Electromagnetic compatibility VERSAJET III Hydrosurgery System (REF 66802146) 18
16. Guidance and manufacturer’s declaration – electromagnetic emissions
VERSAJET III Hydrosurgery System (REF 66802146) 20
17. Warranty 21
18. Appendix A
Company position regarding the reprocessing and reuse of single-use only medical devices 22
19. Appendix B
Ordering Information 22

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1. Description
The VERSAJET◊III Hydrosurgery System
consists of a console, foot pedal and a hand
piece. There are dierent 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 so 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),
• so tissue debridement and cleansing of
surgical sites.
3. Safety
This user manual contains important
information regarding the safe and eective
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 so 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 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 aer 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.

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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. 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. Side air vents – allow for air to enter the console to cool the motor
1
2
4
5
6
3
1

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6.1.3. Rear panel layout
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.
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
30721
YYYY-MM-DD
66802146
100-240V~ 50/60Hz 600W
T 6.3A H x2 250V IPX3
FCC ID: 2AWH9-VJIII
VERSAJET◊III
Hydrosurgery System Console
Smith& Nephew Medical Limited,
101Hessle Road, Hull HU3 2BN, England
©2022 Smith+Nephew. ◊Trademarkof Smith+Nephew
Certain marks Reg. US Pat. & TM O.
This product may be covered by one or more US Patents.
See: www.smith-nephew.com/patents
1
2
3
VERSAJET◊III
2 1
3
4
5

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6.3. Single-Use Hand Piece
The sterile VERSAJET◊III Hand Piece and associated tubing should be disposed of aer use as
clinical waste.
The hand piece has an operating window located at the instrument’s distal tip. When the
system is in operation, a stream of pressurized saline travels across the opening and creates
a localized vacuum eect, following the principles of the Venturi eect. 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. 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
2
3 4
5
6
71
8

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6.3.1. Hand Piece Options
There are two single-use VERSAJET◊III hand piece types – PRECISION and PROCLINICAL.
VERSAJET◊III PRECISION Hydrosurgery System Hand Piece
VERSAJET◊III PROCLINICAL Hydrosurgery System Hand Piece
This Hand Piece has a 20 minute continuous debridement time limit.
Order no. Description
66802150 VERSAJET◊III
PROCLINICAL Hand Piece
(45º/14mm)
For outpatient setting only
66802151 VERSAJET◊III
PROCLINICAL Hand Piece
(45º/8mm)
For outpatient setting only
14mm
45°
8mm
45°
Order no. Description
66802147 VERSAJET◊III PRECISION
Hand Piece
(15º/14mm)
For operating room only
66802148 VERSAJET◊III PRECISION
Hand Piece
(45º/14mm)
For operating room
and outpatient setting
66802149 VERSAJET◊III PRECISION
Hand Piece
(45º/8mm)
For operating room and
outpatient setting
14mm
15°
14mm
45°
8mm
45°

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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
VERSAJET◊III Hand Piece
Flow Rate
(mL/min)
Pressure
(psi / bar)
1 82 1448/100
2 96 1962/135
3 110 2518/174
4 123 3139/216
5 137 3856/266
6 150 4635/320
7 167 5713/394
8 179 6549/452
9 189 7308/504
10 197 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.
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 dicult 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.

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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 sucient 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 so 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

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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
eciency 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.
7.9. 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. Aer 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 facility’s standard
guidelines for biohazardous waste
disposal.
3. Switch the device o by pressing the
power button.
4. Disconnect the power supply cable.
NOTE: Aer each use, thoroughly clean the
console, foot pedal and power cord. Please
refer to the Cleaning and Maintenance section.

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7.12. Hand piece quick set-up pictorial guide
C
B
A
A
C B

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8. Console cleaning
and maintenance
8.1. Cleaning
Follow your healthcare facility’s 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 manufacturer’s instructions. Aer
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
facility’s standard guidelines for
biohazardous waste disposal or as
prescribed by the environment in which
the console was used.
This procedure should be performed aer
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.
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 console’s 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.

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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 dierent 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
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.
Foot pedal notification
window appears on
screen
Foot pedal not connected
properly
• 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 notification
window "Hand piece
disconnected" appears
on screen
Hand piece is removed Connect new hand piece
Hand piece notification
window "Hand piece not
recognized" appears on
screen
Console fails to recognize
hand piece
Connect new hand piece
Hand piece notification
window "Hand piece
unlocked" appears on
screen
Hand piece is loosing Rotated and locked hand piece
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 dierent electrical outlet
3. Ensure the yellow high-pressure tube on Hand piece
is not kinked, obstructed or tangled
4. Wait at least 5 seconds aer 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

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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
Note: Priming takes
approximately 1 min at
power level 10
No / obstructed fluid
supply
1. Ensure saline bag is full and fluid flows freely
2. Check that pinch clamp is fully open
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
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
Excessive spray /
spattering
Note: Hand piece should
not come into contact
with bone tissue as it
obstructs fluid flow and
causes spraying
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
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.
Obstructed waste
evacuation tube
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)
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 blanks out and
power button LED
flashing
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

16
EN
11. Glossary of symbols
Follow instructions
for use Do not re-use Lot number
Consult instructions
for use Date of manufacture Serial number
Sterilized using
ethylene oxide Manufacturer Product catalog number
Do not use if
package is damaged
Keep Away
From Sunlight Keep dry
Temperature limitation Humidity limitation Atmospheric pressure
This way up
Equipment
classification Isolation
type BF applied part
Fuse Rating
Non-ionizing
electromagnetic
radiation
Caution Brightness
Caution: U.S. Federal
law restricts this
device to sale by
or on the order of a
physician.
Federal
Communications
Commission
Certification
Identification Number
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.
FCC ID: 2AWH9-VJIII

17
EN
13. System specifications
Front panel
Power switch, ON/OFF (I/O)
Foot pedal connection
Hand piece unlocked
Hand piece locked
Adjusting Power Setting
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 IEC60320-1 C14 style power
inlet with dual fuse holder
Power cord Detachable hospital grade
power cord with C13 plug
Power input rating 100-240V~ 50/60Hz 600W
T 6.3A H x2 250V
Fuse ratings Dual T 6.3A H 250V 5x20mm
Mode of operation Continuous
Applied part
classification Type BF
Equipment
classification Class I
Compliance IEC60601-1
IEC60601-1-6
Listing To be defined
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 / 15
IP classification IPX8
Power cord
Length 4.6m / 15 (US)
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 41°F (5°C) to 77°F (25°C)
Product use 50°F (10°C) to 90°F (32°C)
Humidity range 10% to 90% RH,
non-condensing
Atmospheric
pressure
700 to 1060 hPa
Console environmental conditions
Unless otherwise stated, the following
conditions apply for product use as well as
shipping and handling.
Temperature range
Storage -4°F (-20°C) to 131°F (55°C)
Product use 50°F (10°C) to 90°F (32°C)
Humidity range 10% to 90% RH,
non-condensing
Atmospheric
pressure
700 to 1060 hPa

18
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 o 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 dierent 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.
Conformément à la réglementation d'Industrie Canada, le présent émetteur radio peut
fonctionner avec une antenne d'un type et d'un gain maximal (ou inférieur) approuvé pour
l'émetteur par Industrie Canada. Dans le but de réduire les risques de brouillage radioélectrique
à l'intention des autres utilisateurs, il faut choisir le type d'antenne et son gain de sorte que
la puissance isotrope ayonnée équivalente (p.i.r.e.) ne dépasse pas l'intensité nécessaire à
l'établissement d'une communication satisfaisante.
Canadian Department of Communications Compliance Statement CAN ICES-3(B)/NMB-3(B)
Guidance and manufacturer’s 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.

19
EN
Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidelines
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±2 kV, ±4 kV, ±8 kV,
±15 kV air
±8 kV contact
±2 kV, ±4 kV, ±8 kV,
±15 kV air
Floors should be wood, concrete or ceramic tile. If
floors are synthetic, the relative humidity should
be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV
For power supply lines
100 kHz repetition
frequency
±2 kV
For power supply lines
100 kHz repetition
frequency
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
±0.5 kV, ±1 kV
Line-to-line
±0.5 kV, ±1 kV, ±2 kV
Line-to-ground
±0.5 kV, ±1 kV,
Line-to-line
±0.5 kV, ±1 kV, ±2 kV
Line-to-ground
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
Interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
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
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
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.
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
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:
Conducted RF 3 Vrms 150 kHz
to 80 MHz
3 Vrms 150 kHz
to 80 MHz
IEC 61000-4-6 6 Vrms 150 kHz
to 80 MHz
In ISM radio bands
6 Vrms 150 kHz
to 80 MHz
In ISM radio bands
d= 0,58 √P
Radiated RF
IEC 61000-4-3
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)
where Pis 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:
NOTE 1: At 80 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic
propagation is aected 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.