Integra CUSA NXT User manual

Confidential – For internal use only.
NS3042-12/08
Ultrasonic Tissue Ablation System
In-Service Guide

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CUSA NXT™ In-Service Guide
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Confidential - For internal use only.
Table of Contents
Introduction
 Equipment Check List
 Equipment from the Loaner Pool
Page 3
Page 3
Page 4
CUSA NXT In-Service Check List for NeuroSpecialist Page 5
CUSA NXT System
 CUSA NXT Console
 CUSA NXT Touch Screen Monitor
 CUSA NXT Service Module
 CUSA NXT Handpieces
Page 7
Page 7
Page 11
Page 11
Operating CUSA NXT During the Surgery
 Customizing the User Settings Page 16
Page 17
Shutting Down the CUSA NXT™ System
 Dismantling the System After the Surgery
 Disassembling the Handpiece
 Guidelines for Cleaning the Handpieces
Page 18
Page 18
Page 19
Page 19
Sterilization Instructions
 Recommended Sterilization Instructions
 Steam Sterilization
Page 20
Page 20
Page 20
Product Support Page 21
CUSA NXT Pre-Operative Set-up
 Console and Service Module Set-up
 Handpiece Assembly
 Tubing Assembly
 Priming the Handpiece
Page 12
Page 12
Page 13
Page 14
Page 15
Appendix 1: CUSA NXT Pool Request Form
Appendix 2: CUSA NXT Competency Validation Form for the Hospital

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CUSA NXT™ In-Service Guide
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Introduction
As a NeuroSpecialist at Integra NeuroSciences, you are representing a comprehensive line of
market leading ultrasonic aspirators, including the new CUSA NXT. Your competency at ex-
plaining the CUSA NXT System features and benefits and operating the equipment and dem-
onstrating its functions will help ensure that your customers Operate with Confidence™!
On a daily basis you are asked to do non-clinical and clinical evaluations, in-service the staff
and the surgeons, provide sterilization instructions for the handpieces, explain how the system
works, and much more. This In-Service Guide is put together to help you manage these vari-
ous tasks with CUSA NXT, and deliver to your accounts the high quality customer service and
support they expect.
Equipment Check List
Before you schedule an evaluation, a demo or an in-service, make sure that you have all the
needed equipment available.
CUSA NXT System
 CUSA NXT Console
 CUSA NXT Service Module
 Footswitch
 Different 24 kHz and 35 kHz CUSA Selector
handpieces
 Handpiece sterilization trays
 Manifold tubing
 Micro tubing kit extension, if MicroSurgical
handpiece is used
 MRI tubing kit extension, if MRI safe hand-
pieces are used
 Tips and flues
 Wrench sets for handpieces
 Contamination guard for the Service Module
 CUSA NXT in-service DVD
 Sterilization instructions
Hospital provided components
 500 ml (or more) of normal IV saline or Lac-
tated Ringers
 Suction canister
Accessories for non-clinical demo
 Apple for removing the pulp from the skin
 Orange to dissect the pulp from the segments
 Permastone bone cube and/or T-bone steak
or pork chop for Selector SaberTip™ demon-
stration
 Plate to place the items on
 Knife to cut the apple and orange

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CUSA NXT™ In-Service Guide
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Equipment from the Demo Pool
If you need to obtain any items from the loaner pool, please do so by taking the following
steps:
1. Fill in the CUSA NXT Pool Request form (see Appendix 1)
 Please contact sales support to get your copy if you don’t already have one
 Remember to request the Console and Service Module shipping crates in the form
 Remember to request the wrench sets for the handpieces as well, as they do not
automatically ship with the handpieces.
2. Email the form to: [email protected]
All CUSA NXT Consoles, Service Modules and CUSA Selector handpieces in the demo pool
ship from our Service and Repair Center in San Diego, CA.
Before returning loaner pool equipment, please contact San Diego at 1-858-455-1115 ext.
207 to get an RMA for your return shipment.

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CUSA NXT™ In-Service Guide
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CUSA NXT In-Service Check List for the NeuroSpecialist
Below you will find an In-Service Check List to guide you through the in-service situation. As
some hospitals require competency validation forms for their staff training purposes, we have
put together one (see Appendix 2). This form is also available in PDF and you can download
a copy from the Tissue Ablation SharePoint site.
1. Discuss the basic principles of ultrasonics
 Fragmentation
 Irrigation
 Aspiration
2. Discuss the main differentiating features and benefits of the CUSA NXT System
 Ease of set-up
 Modularity
 Separate Console and Service Module
 Ability to hook up the Console to hospital wall suction
 NXT Digital Architecture™
 Touch screen user-interface
 Custom presets
 On-line help
 Linear footswitch
 Digital architecture
 Advanced aspiration system
 MRI safety
 Selector Saber Tip™
3. Identify the main clinical uses for the CUSA NXT
 Neurosurgery
 General surgery (liver)
 GYN/Oncology
4. Identify the components of the CUSA NXT System
 CUSA NXT System components:
 CUSA NXT Console
 CUSA NXT Service Module
 Footswitch
 Touch-screen user-interface
 Different 24 kHz and 35 kHz CUSA Selector handpieces
 Handpiece sterilization trays
 Manifold tubing
 Micro tubing kit extension, if MicroSurgical handpiece is used
 MRI tubing kit extensions, if MRI compatible handpieces are used
 Tips and flues
 Wrench sets
 Contamination guard for the Service Module
 CUSA NXT in-service DVD
 Hospital provided components:
 500 ml (or more) of normal IV saline or Lactated Ringers
 Suction canisters

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5. Perform the in-service for the CUSA NXT
 Setting up the Console
 Setting up the 24 kHz and 35kHz handpieces and explaining the handpiece con-
nections
 Touch screen user-interface
 Recommended settings
 80 % power, 3 ml/min irrigation, 80 % aspiration for soft tissue
 80 % power, 6 ml/min irrigation, 80 % aspiration for hard tissue bone)
 Custom Presets
 Alerts
 On-line help
 In-service DVD
6. Set up the CUSA NXT System for the clinical evaluation or surgery
 Setting up the Console and Service Module
 Setting up the 24 kHz and 35 kHz handpieces
7. Operate the CUSA NXT in non-clinical evaluations
 Removal of apple pulp from the skin
 Orange segment dissection
 Permastone bone cube for the CUSA Selector SaberTip demo
8. Troubleshoot the CUSA NXT if it fails to operate or if it malfunctions
 Handpiece Alert
 Aspiration Issues
 Irrigation Issues
 Ultrasonic Power Issues
 Refer to the CUSA NXT Troubleshooting Guide or CUSA NXT Operator’s Manual for
detailed troubleshooting guidelines
9. Shut down the CUSA NXT system after the surgery/evaluation
 Disassembling the system and handpieces
 Discarding the disposable items in a proper manner
10. Communicate the proper cleaning and sterilization protocols to the OR Staff and SPD

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CUSA NXT System
The use of the CUSA NXT will require the following items:
 CUSA NXT Console
 CUSA NXT Service Module or hospital wall suction outlet
 One hard waste collection canister
 Tubing Kit
 MicroSurgical Tubing Kit Extension (if MicroSurgical hand-
piece is used)
 MRI Tubing Kit Extension (if MRI handpieces are used)
 IV bag: 500 ml (or more) saline or Lactaid Ringers
 CUSA Selector handpiece(s)
 CUSA Selector handpiece wrench set, appropriate to the
handpiece
 CUSA Selector handpiece sterilization tray(s)
CUSA NXT Console
Console rear panel
1. Power button
2. AC power inlet
3. Cooling fan air outlet
4. Footswitch port
5. Ground point
6. Volume control knob
Console left side panel
1. Irrigation pump
2. Aspiration control port
3. Pinch valve
4. Handpiece connection port for the 24 kHz handpiece
5. I.V. pole
Console front panel
1. Handpiece connection port for the 35 kHz handpiece
2. Handpiece connection port for the 24 kHz microsurgical
handpiece

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CUSA NXT Touch Screen Monitor
The CUSA NXT Console provides a touch screen monitor for viewing and controlling the
power, irrigation and aspiration levels during an ultra-
sonic case.
The touch screen provides the following tools:
1. Status and alarm symbols
2. Ultrasonic control scales for power, irrigation and as-
piration
3. Information panel displaying the accumulated ultra-
sonic time and the current vacuum levels
4. Menu buttons for priming the handpiece, customizing
the user settings and viewing the online help.
Status and Alarm Symbols
The file symbols appear on the top of the touch screen providing status information on the
major ultrasonic components. During normal operation, all the symbols appear green. If an
error occurs with any of the major components, an alarm will sound and the respective sym-
bol will turn from green to flashing yellow.

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Adjusting the Ultrasonic Control Scales
Use the power, irrigation, and aspiration scales to control the major ultrasonic
settings during a case.
Adjusting the power level
Use the power scale (orange) to specify the ultrasonic power output (tip ampli-
tude). The power settings range between 10% and 100%. Note that raising the
power setting will increase the vibration of the handpiece tip and thus increase
tissue fragmentation rate. To adjust the power by 5% increments, use the arrows to
the right of the scale. To adjust the power by 10% increments, press the segment
bars on the scale.
Adjusting the irrigation level
Use the irrigation scale (blue) to specify the rate of irrigation that will be delivered
to the handpiece. The irrigation rate ranges between 2 and 20 ml/minute. To adjust
this rate by 1 ml/minute increments, use the arrows to the right of the scale. To ad-
just the rate by 2 ml/minute increments, press the desired segment on the scale.
Adjusting the aspiration level
Use the aspiration scale (green) to specify the aspiration rate of the total available
suction of the source of vacuum employed. To adjust the rate by 5% increments,
press the arrows to the right of the scale. To adjust the rate by 10% increments,
press the segment bars on the scale. Note that typical aspiration rates are be-
tween 30% and 100%.

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Verifying General Ultrasonic Information
Use the information panel to determine the general status of the current operating modes and
equipment selection. This panel provides the following information:
 The Timer displays the total accumulated ultrasonic time since the
machine was powered on. This value will reset to 00:00 if the machine
is turned off for more than 30 minutes.
 The Vacuum symbol displays the current vacuum level from the
aspiration source. This level is measured in mm hg units.
Displaying Menus for Prime Mode, Customized Settings, and Online Help
Use the menu buttons to access features for priming the handpiece, customizing user settings,
and displaying online help. Note the following buttons:
 Prime: Displays the prime panel for priming the handpiece for surgery
 Settings: Displays options for saving customized settings and specify-
ing different languages.
 Help: Displays the online help system for accessing information on
performing common tasks.

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CUSA NXT Service Module
The CUSA NXT service module provides a convenient, mobile base for the CUSA NXT Console,
as well as a source of suction and waste collection. It is controlled from the console and has
no user accessible controls.
Service module front
1. Suction port
2. Container receptacle
3. Casters
Service module back
4. Power lead
5. Communication cable
6. Storage area for footswitch and power cord
7. AC power inlet
8. Power switch
Handpieces
The CUSA NXT supports the 8 different CUSA Selector handpieces that operate at two differ-
ent frequencies, 24 kHz and 35 kHz. The following table gives an overview of different hand-
pieces, wrenches and tips. See the CUSA Selector and CUSA NXT Catalog for individual part
numbers.
The handpiece cords are conveniently color coded as follows:
 The 35 kHz handpiece plugs are green
 The 24 kHz handpiece plugs are red
 The 24 kHz MicroSurgical handpiece plug is black
Handpiece Category Handpiece type Wrench Tips
Neuro Handpiece 24 kHz Neuro Long Neuro Wrench Set Single use
Neuro Handpiece 24 kHz Neuro Short Neuro Wrench Set Single use
Neuro Handpiece 35 kHz Neuro Neuro Wrench Set Single use
Neuro Handpiece 24 kHz MicroSurgical Micro Wrench Set Single use
Standard Handpiece 24 kHz Straight Standard Wrench Set Reusable up to 100 hours
Standard Handpiece 24 kHz Angled Standard Wrench Set Reusable up to 100 hours
Standard Handpiece 35 kHz Straight Standard Wrench Set Reusable up to 100 hours
Standard Handpiece 24 kHZ Laparoscopic Laparoscopic Wrench Set Reusable up to 100 hours

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CUSA NXT Pre-Operative Set-up
Console and Service Module Set-up
1. Depending on the type of suction source being used, do one of the following:
 If the Service Module is being used, place the CUSA NXT Console on top of the
CUSA NXT Service Module and position it in a convenient location outside the sterile
field.
 If the Service Module is not being used, place the Console on a trolley outside the
sterile field. Note that the external suction source must operate at a minimum vac-
uum pressure between 560 mmHg and 620 mmHg with a free air flow capacity
more than 42 L/min. Plug one end of the detachable power cord into the Console,
and the other end to the wall outlet.
2. If the Service Module is being used, plug the Service Module cord located in the module’s
top rear compartment into the power cord connector (1) on the rear of the Console.
3. Plug one end of the detachable power cord into the Service Module’s power connector
(1) on the rear of the module, and the other end to the wall outlet.
4. Connect the aspiration controller cable (1) located in the Service Module’s top rear com-
partment to the port on the bottom of the Console (2) inside the compartment
5. Tighten both connector screws.
6. Thread the locking thumbwheel located in the Service Module door into the threaded hole
on the bottom of the Console inside the compartment. Tighten fully.

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7. Place a suction canister in place and ensure that the contamination guard is fitted to pro-
tect the vacuum pump in the Service Module.
8. Connect tubing from the contamination guard to the vacuum port on the canister.
9. Turn the Service Module power switch on. This switch must be turned on to power the
CUSA NXT Console.
10. Lift the I.V. pole on the rear of the Console to an elevated position and turn the knurled
locking ring clockwise to secure the extended section.
11. Place the sterile intravenous fluid container onto the hook at the end of the pole.
Handpiece Assembly
Handpiece is assembled in a sterile field by a scrub nurse.
1. Place the sterile handpiece and accessories on the table in the sterile
field and unwrap.
2. Using the appropriate wrench set, secure Flat 2 (2) of the handpiece into
the designated slot of the holder. Using your fingers, screw the silver an-
gled extension into the handle. Using the wrench, tighten the extension
by turning it clockwise
3. Reposition the handle of the handpiece in the holder, securing Flat 1 (1)
of the angled extension into the designated slot of the holder. Using your
fingers, screw the tip into the angled extension, and using the wrench,
tighten the tip by turning it clockwise.
4. Attach the black shroud onto the handpiece by centering and aligning
the shroud with the silver angled extension. Note that failure to center
the shroud may cause the handpiece to overheat.
5. Attach the clear flue onto the shroud until firmly placed in position.

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Tubing Assembly
The Circulating nurse will peel back the outer covering of the tubing kit and offer the sterile
contents to the scrub nurse.
1. For the Microsurgical handpiece, the circulating nurse will peel back the outer covering
of the Microsurgical tubing kit and offer the sterile contents to the scrub nurse.
2. For all MRI handpieces, have the circulating nurse will peel back the outer covering of the
MRI tubing extension and offer the contents to the scrub nurse.
The Scrub nurse will perform the following tasks:
1. Open the appropriate tubing kit onto the sterile field.
2. Retain the yellow stylet and the white hose clips in the sterile field.
3. Connect the tubing to the handpieces. Attach the double lumen tube
from the standard tubing kit to the irrigation (1) and aspiration (2) ports
on the back of the handpiece.
 If you are using If you are using the Microsurgical or MRI handpieces:
 For the Microsurgical handpiece, attach the micro tubing kit to
the irrigation (1) and aspiration (2) ports on the back of the handpiece. Connect
the other end of the tubing to the standard tubing kit.
 For all MRI handpieces, connect the standard tubing to the MRI tubing extension
and then attach the sterile double lumen tubing directly to the rear end of the
handpiece. Note that the larger lumen fits on the large central aspiration port
while the smaller lumen fits onto the smaller irrigation port.
4. Using the white hose clips supplied with the tubing kit, secure the tubing
and handpiece cord.
5. Depending on the console location, reserve the desired amount of tub-
ing to be used in the sterile field.
6. Hand the remaining tubing to the console location in the non-sterile
area.

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The circulating nurse will perform the following tasks:
1. Connect the handpiece plug into the color coded socket on the console by aligning the
red dots and pushing the plug firmly into the socket until it clicks.
 The 35 kHz handpiece plugs are green
 The 24 kHz handpiece plugs are red
 The 24 kHz MicroSurgical handpiece plug is black
2. Push the open part of the filter on the tubing kit fully into the aspiration
filter port on the left side panel of the console (2).
NOTE! This connection is airtight, but it is not rigid.
3. Route the aspiration tubing through the pinch valve on the side panel
and connect the open end of the elbow on the patient port on the suc-
tion canister (1).
NOTE! If the CUSA NXT Service Module is not used, connect the
elbow to the hospital suction system.
4. Open the peristaltic pump (1) and route the irrigation tubing over the
rollers of the pump. Close the clip on the irrigation pump.
5. Remove the protective cap from the spike, and spike the IV bag.
6. Connect the footswitch cord to the appropriate port on the rear of the
Console panel.
The system is now ready to be turned on.
NOTE! For using CUSA NXT in MRI environment, please refer to CUSA NXT Operator’s Manual
for detailed instructions.
Priming the Handpiece
CUSA NXT has an automatic priming feature.
1. Turn on the system by pressing the main power button located on
the rear panel of the Console and on the Service Module (if utilized);
the prime screen will appear automatically.
2. On the prime screen, press the start button; the CUSA NXT will start to
prime the handpiece and display a progress bar. To stop the priming
process at any time, press the stop button.
3. During the priming process, verify that fluid completely fills the line to
the handpiece and irrigant flows from the tip of the handpiece. If
irrigant does not flow from the tip, press the prime button and re-
start the priming process until fluid starts to flow from tip. To stop the
priming process at any time, press the stop button.
4. After priming the handpiece, the main screen will appear.
The system is now ready for use.
Caution

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Operating CUSA NXT During the Surgery
After setting up the system, it is ready to be used for surgery. Note the follow-
ing guidelines when using the CUSA NXT during surgery:
 Increasing the power setting (orange) increases cell disruption at the
handpiece tip.
 Increasing the irrigation setting (blue) increases the irrigation flow.
 Increasing the aspiration setting (green) increases the suction at the
handpiece tip.
During the surgical procedures you may adjust these variables by adjusting
the appropriate scales on the touch screen.
1. Verify that the handpiece is fully primed.
2. Set the aspiration, irrigation, and power levels to the desired settings. If desired, use the
presets option to select the pre-defined settings (see page 17). Recommended settings
are:
 80 % for power
 3 ml/min for irrigation
 80 % for aspiration
3. Hold the handpiece in the sterile field and verify the following:
 The tip is not in contact with any object.
 The aspiration and irrigation tubes are free from kinks or other obstructions.
4. Press the Power pedal on the Footswitch for at least 2 seconds to activate the handpiece.
Verify that a fine aerosol spray of irrigant appears at the tip showing that ultrasonic power
is present.
5. To operate the ultrasonic aspirator, press the Power pedal. Aspiration operates continu-
ously and irrigation is activated at the pre-set level when the pedal is pressed. Ultrasonic
power is controlled in a linear fashion - increasing as the Power pedal is pressed further
until, at full depression, it reaches the maximum level set on the power display on the front
panel.
6. If the surgeon only wishes to irrigate the operating site, press the Fast Flush Footswitch
pedal. Irrigant will flow from the end of the handpiece at a rate of 50ml/min.
7. If a problem occurs, see CUSA NXT troubleshooting guide, or the CUSA NXT Operator’s
Manual for troubleshooting guidelines.
8. If blockage occurs in the handpiece during operation, use the supplied sterilized nylon
stylet packaged with each tubing set to clear it. When using the stylet, pass it into the tita-
nium tip of the handpiece until the blockage is cleared. After clearing the blockage, im-
merse the tip into sterile water or saline.
9. If for any reason the Console is powered down for a period of less than 30 minutes and
then powered up, the Surgery Mode is immediately accessed, bypassing the normal prim-
ing procedure.
NOTE! During intervals of operative use, we recommend immersing the tip of the handpiece
momentarily into sterile water or saline. This will prevent blood and tissue debris from drying on
the inner surfaces of the handpiece and aspiration line and minimize the risk of a blockage in
the aspiration system.

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Customizing the User Settings
On the main screen, press the settings button to save ultrasonic settings and specify
languages for onscreen text. On the settings screen, note the following:
Saving Customized Ultrasonic Settings
Press the presets button to save customized settings or restore the default settings.
To save customized settings for subsequent sessions:
1. Adjust the power, irrigation, and aspiration settings to the desired levels.
2. On the main screen, press the settings button and choose the presets option.
 Presets: Provides function for saving and restoring
power, irrigation, and aspiration values.
 Language: Provides option for displaying the touch
screen content into 5 different languages: English,
French, Italian, German, and Spanish.
3. On the displayed panel, press the save current set points button. The system will save the
current power, irrigation, and aspiration levels. The next time the system is turned on, the
CUSA NXT system will restore these values.
To restore the default settings, press presets on the settings panel and choose restore
default set points option. The CUSA NXT system will restore the factory
settings for the power, irrigation, and aspiration levels.

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Shutting Down the CUSA NXT System
Dismantling the System After Surgery
After an operative procedure, dismantle the system and prepare it for storage.
1. If the same settings used during the operation may be required for future use, use the pre-
set feature to save them.
2. Remove the handpiece from the operating area and flush it by aspirating at least 100 ml
of isotonic fluid. Note that the residue from the intravenous fluid container usually provides
a convenient source of fluid.
3. Remove the hose clips from the handpiece cable.
4. Disconnect the tubing set from the handpiece. Disconnect the contamination guard tub-
ing from the vacuum port of the canister.
5. Remove the intravenous fluid container from the tubing set and discard.
6. Remove the irrigation tube from the peristaltic pump, the aspiration tube from the pinch
valve and the aspiration filter from the Console. If using a disposable liner, remove it from
the suction canister and discard together with the entire tubing set. If using a hard canis-
ter, discard it with entire tubing kit.
7. Turn off the power on the rear panel of the CUSA NXT Console and Service Module (if util-
ized). Remove the main power cord from the Console or Service Module as appropriate,
wipe clean and store in the rear cupboard of the Service Module (if utilized).
8. Disconnect the Footswitch and wipe clean. If the Footswitch is contaminated with blood
or fluid, it may be cleaned by immersing it in warm water containing detergent or disin-
fectant (the port must be kept dry) and rinsed. Allow the Footswitch to drain after wash-
ing and store in the rear storage area of the Service Module (if utilized).
9. Wipe the Console and the Service Module with a clean cloth dampened with warm wa-
ter and a mild detergent, disinfectant or alcohol when necessary to remove blood or dirt.
Lower the irrigation pole by turning the knurled locking ring counter-clockwise.
10. Remove the handpiece cable from the Console and disconnect from the handpiece.
Wipe the cable with a clean cloth dampened with warm water and a mild detergent,
disinfectant or alcohol when necessary to remove blood or dirt.
NOTE! Do not remove the contamination guard located in the receptacle bay at the front of
the Service Module. We recommend that the contamination guard is changed every 6
months, or earlier if needed.

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Disassembling the Handpiece
Prior to sterilization, disassemble and clean the CUSA Selector handpiece:
1. In a sink or bowl, prepare a cleaning solution containing warm water with
detergent. This is necessary for cleaning the handpiece parts. Consult hos-
pital policy for approved cleaning materials.
2. Remove and dispose of the clear flue in compliance with the hospital pol-
icy for disposal of contaminated waste.
3. Remove the black shroud and place in the cleaning solution.
4. Lay the handpiece in the appropriate wrench holder with the wrench flat
secured in the holder cut-out.
5. Using the appropriately sized end of the wrench, loosen the tip by turning it
counterclockwise. Unscrew the tip and place it in the cleaning solution. If
the tip is single-use only or shows evidence of damage, discard the tip.
6. Reposition the handle of the handpiece in the holder cut out and using
the same wrench set as before, loosen the angled extension by turning it
counterclockwise.
7. Detach the angled extension and place it in cleaning solution.
8. Keeping the plug dry, place the handpiece handle and cord into cleaning
solution.
Guidelines for Cleaning the Handpieces
1. Clean all handpiece parts thoroughly using an aspiration port brush (part # 1523101) to
clean the inner channels, pushing it in the direction of aspiration (i.e. from tip to handle).
2. Rinse all parts in clean water (keeping the plug dry) and dry thoroughly.
3. Clean and rinse the wrench set and add it to the sterilization tray.
4. Place the wrench set in sterilization tray.
5. Place the disassembled handpiece and accessories (tip, shroud, flue, and angled exten-
sion) in a sterilization tray, adding a new tip and new flue when necessary.
6. Sterilize according to hospital policy (see page 20 for sterilization instructions).

Page 20
CUSA NXT™ In-Service Guide
NS3042-12/08
Confidential - For internal use only.
Sterilization Instructions
Recommended Sterilization Instructions
Before sterilization, clean the handpiece and accessories as described on page 19. Note that
sterilization systems in use at hospitals are chamber specific. As a result, Integra LifeSciences can
only recommend a reference for hospitals to aid the sterilization parameters set for your hospital
system. Integra LifeSciences has validated the following sterilization cycles for your considera-
tion.
Steam Sterilization
Place the disassembled handpiece and applicable accessories (tip, shroud, flue and extender)
into a sterilization tray. Double-wrap the sterilization tray in suitable sterilization grade paper, or
place fresh filters in the filter ports situated in the top and base of the sterilization tray. When us-
ing filters, verify that they are replaced after each sterilization cycle. Integra LifeSciences also
recommends using tamper resistant locks in conjunction with the filters. Place these locks on the
handle of the sterilization tray to ensure that the sterility has not been broken.
Wrapping Temperature Cycle Dwell Time Dry Cycle
Wrapped 121° C
250° F Pre-vacuum cycle 16 minutes 20 to 30 minutes
Wrapped 134° C
273° F Pre-vacuum cycle 5 minutes 20 to 30 minutes
Wrapped 134° C
273° F
Pre-vacuum
cycle 3 minutes 10 minutes
Unwrapped 134° C
273° F Pre-vacuum cycle
(FLASH)
3 minutes 5 minutes
Allow the handpiece to cool completely before use. Note that it is the user’s
responsibility to verify that the handpiece and components are completely dry prior
to setup.
CAUTION: Validation of the steam cycles described above has been conducted; however, it
is solely the decision of the hospitals to approve the use of these cycles.