Integra CUSA Clarity Configuration guide

Integra®CUSA®Clarity
Ultrasonic Surgical Aspirator System
Cleaning Instruction Guide

Integra®CUSA®Clarity – Ultrasonic Surgical Aspirator System
Disassembling, Cleaning, and Sterilizing the System
PREFACE
Intended Audience
This cleaning instruction guide and the equipment it describes are for use only by qualified medical professionals trained in the par-
ticular technique and surgical procedure to be performed. It is intended as a guide for cleaning the CUSA® Clarity Ultrasonic Surgical
Aspirator System only.
Overview
This section describes how to disassemble the system and clean the console, handpiece, and components.
CAUTION Federal (USA) law restricts this device to
sale by or on the order of a physician.

2
Disassembling the Handpiece
3. Remove the aspiration tubing from the aspiration
port at the base of the handpiece.
2. Remove the handpiece cable from the aspiration
tubing clips.
4. Remove the irrigation tubing from the Luer fiing
on the handpiece flue.
1. Remove the irrigation tubing from the clip at the
base of the handpiece.
Disassembling the System
CUSA®Clarity Items to Keep and Discard Aer a Surgical Procedure
Keep Discard
Handpiece Nosecone
Contamination Guard Flue
EUTs (with less than 5 uses) EUTs (aer 5 uses)
Torque Base Tip Stylet
Footswitch Torque Wrench
Power Cord CUSA Quick Connect™
Cartridge and Tubing Set
Sterilization Tray Aspiration Canister
Irrigation Supply
Specimen Trap (if used)
Single Use Tip

3
Integra®CUSA®Clarity – Ultrasonic Surgical Aspirator System
Disassembling, Cleaning, and Sterilizing the System
5. Slide the flue off of the nosecone base along the tip. 6. Twist off the nosecone counter-clockwise until it unlocks.
7. Slide the nosecone off the tip. 8. Place the handpiece on the torque base as shown and make
sure that the 2 flat metal sides fit snugly in the metal slot at
the end of the base.
9. Hold the handpiece in the base and place the torque
wrench (color side towards handpiece) over the tip.
10. Rotate the torque wrench counter-clockwise.
11. Unthread the tip from the handpiece connecting
body by turning the tip counter-clockwise by hand.
12. Discard the items (listed in the table in “CUSA® Clarity Items to Keep and Discard Aer a Surgical Procedure” on page 2)
in compliance with hospital policy for contaminated waste.
CAUTION
To avoid product damage, always use the torque base
to hold the handpiece while using the torque wrench to
tighten or loosen the tip. Avoid over torqueing the tip.

4
Disassembling the Console
2. Disconnect the contamination guard tubing
from the vacuum port of the canister.
3. Open cartridge door, if necessary press the pinch valve
buon, and remove the cartridge from the console by
sliding it up.
4. Detach the handpiece cable from the console by
gently pulling on the handpiece cable connector in
the handpiece port on the front of the console.
5. Unplug the power cord from the wall receptacle
and the console.
6. Disconnect the footswitch cable connector from
the back of the console.
7. Discard the used/contaminated items in compliance with hospital policy for contaminated waste.
Please reference the table “CUSA® Clarity Items to Keep and Discard Aer a Surgical Procedure” on page 2.
1. Detach the aspiration tubing from the patient port on the
canister.
NOTE
The contamination guard should not be removed
from the console unless it is time to replace it
(every six months or when the color changes).

5
Integra®CUSA®Clarity – Ultrasonic Surgical Aspirator System
Disassembling, Cleaning, and Sterilizing the System
Detaching the Contamination Guard
1. Detach the handpiece cable from the console by gently pulling on
the handpiece cable connector in the handpiece port on the front
of the console.
2. Discard the contamination guard in compliance with hospital policy
for contaminated waste.
Powering Down the System
Press the Power buon on the front of the console. The touchscreen will go dark. Do not unplug power cord until system has pow-
ered down.
Cleaning the System
Cleaning the Touchscreen
Make sure the console is unplugged before cleaning it. Clean the touch screen with a lint-free wipe and a cleaner, such as window/
glass cleaner, eyeglass cleaner, or a quaternary ammonia disinfectant.
Cleaning the Console and Cart
1. Unplug the power cord from the wall receptacle and the console.
2. Clean the surface with a lint-free wipe soaked with one of the following:
• 70% IPA
• Super Sani-Cloth®
• Sani-Cloth® Bleach
3. Make sure the surfaces remain visibly wet for a minimum of two (2) minutes, then air dry.
4. Clean the wheels at the base of the system cart to ensure that the four anti-static wheels function correctly.
CAUTION Product damage may result if you do not follow the
instructions described in the cleaning section.
WARNING Electric Shock Hazard - Always unplug
the CUSA Clarity System before cleaning it.
NOTE The contamination guard should not be removed from the console unless
it is time to replace it (every six months or when the color changes).
NOTE Do not wipe the touch screen with a sponge
because it may scratch the surface.
NOTE
Make sure that the surface of the wheels is free
from dirt and dust. Make sure that the surface is
completely dry before using the system again.
NOTE Never apply cleaner directly to the touch screen.
WARNING Do not allow fluids to enter the console.

6
Cleaning the Handpiece, EUT, and Torque Base
The handpiece, extended use tips, and torque base may be cleaned by either the manual cleaning or autowash cycle process prior to
sterilization. For Sterlization Parameter, see “Sterilizing the System” on page 8 .
Manual Cleaning
1. Use the provided cleaning brush to clean out the internal channels of both the handpiece and tip. Continue to pass the brush
through the tip and handpiece until it comes out clean.
2. Clean the exterior of the handpiece and tip with a lint free cloth soaked with warm water and a non-alkaline detergent.
3. Use the cloth to manually clean the junction where the tip aaches.
4. Rinse the entire handpiece and tip thoroughly with water and dry with a so cloth.
Autowash Cycle:
Before auto washing, use the provided cleaning brush to thoroughly clean the internal channels of the handpiece and tip. Continue
to pass the brush through the tip and handpiece until it comes out clean.
In a Steelco DS50 DRS or equivalent washer/disinfector, perform a prewash cycle of 5 minutes, then clean using a 1% solution of
alkaline detergent (neodisher® MediClean forte or equivalent, final pH between 10.0-11.5) for 10 minutes at 60°C (140°F), disinfect for
10 minutes at 93°C (199.4°F), and dry for 20 minutes.
Cleaning the Footswitch
1. Disconnect the footswitch from the console.
2. Wipe it clean.
3. If the footswitch is contaminated with blood or fluid:
a. Immerse the footswitch in warm water containing
detergent or disinfectant.
b. Rinse the footswitch with clean water.
4. Allow the footswitch to drain aer rinsing.
Sterilization Tray Cleaning
Use a neutral detergent to clean the tray.
NOTE Do not clean the sterilizer tray with
abrasives. Product damage will result.
NOTE Make sure to keep the connector dry.
NOTE Make sure to keep the handpiece cable connector dry.

7
Integra®CUSA®Clarity – Ultrasonic Surgical Aspirator System
Disassembling, Cleaning, and Sterilizing the System
Sterilizing the System
Packaging the Handpiece and Components for Sterilization
The handpiece and components need to be packaged for sterilization.
Integra provides a sterilization tray for steam sterilization of the CUSA Clarity handpiece. This tray protects the handpiece during ster-
ilization and during transfer to the sterile field. The handpiece and components must be cleaned prior to sterilization, see “Cleaning
the Handpiece, EUT, and Torque Base” on page 6.
Sterilization Tray Layout
➀
➁
➂ ➃
➄➅
➆
1 Handpiece
2 Handpiece Cable Posts
3 Handpiece Connector
4 Nosecone
5 Flue and Stylet
6 Torque Base
7 EUT Slots (3)
8 Lid (Not shown)
Most Common Sterilization Tray Configuration EUT Sterilization Tray Configuration
1. Place the handpiece in the appropriate slot ➀and align it with the outline on the boom of the tray.
2. Wrap the handpiece cable around the posts ➁.
3. Place the handpiece connector in the appropriate slot ➂and align it with the outline on the boom of the tray.
4. Optional. Place the nosecone in the appropriate slot ➃and align it with the outline on the boom of the tray.
5. Optional. Place the flue ➄anywhere on the boom of the tray.
6. Place the torque base in the appropriate slot ➅and align it with the outline on the boom of the tray.
7. Optional. Place the Extended Use Tips (up to 3) in the appropriate slots ➆and align them with the outline on the boom of the tray.
8. Put on the lid ➇on the sterilizer tray.
9. Close and latch the lid.

8
Sterilization Parameters
The CUSA Clarity handpiece and components must be sterilized with steam.
Sterilization Tray Packaging
The handpiece and components can be packaged in the sterilization tray either:
• Wrapped—Sterilization tray double wrapped in hospital CSR material
• Flash (Unwrapped)—Sterilization tray unwrapped
The cycles below are acceptable for sterilizing the CUSA Clarity handpiece and components:
Packaging Temperature Type Time Dry Cycle
Wrapped
132˚C (269.6˚F) Prevac 4 min 30 min
134˚C (273.2˚F) Prevac 3 min 30 min
134˚C (273.2˚F) Prevac 18 min 30 min
Flash (Unwrapped) Prevac 4 min None
Sterilizing the Handpiece and Components with Steam
Sterilizing the handpiece with steam depends on the following factors:
• Temperature
• Exposure time
• Population and resistance of resident bioburden
• Method of air removal from the autoclave
Use the validated steam sterilization cycle parameters in these instructions. If you deviate from this recommended method of steril-
izing, it is your Health Care Facility’s responsibility to validate the deviation. For sterilizing the handpiece with steam, do not exceed
134°C (273.2°F).
CAUTION Do not use sterilization methods involving temperatures in
excess of 134ºC (273.2°F) as this may damage the handpiece.

9
Integra®CUSA®Clarity – Ultrasonic Surgical Aspirator System
Disassembling, Cleaning, and Sterilizing the System
Sterilization of Handpieces and Accessories
You must sterilize the CUSA Clarity handpiece with steam before use. Some of the CUSA Clarity system accessories are sterile,
single-use items. Other accessories are reusable. You must sterilize all reusable accessories with steam before use.
The table below describes the sterilization requirements for the handpiece and accessories. For information on the sterilization
parameters and sterilization procedure for the handpieces and accessories, see “Assembling the System Prior to Use” on page 6-1.
Item Initially Sterile Reusable/Requires
Sterilization by the User
Validated Number
of Sterilizations Cycle Sterilization Method
Handpiece No Yes 200 Steam
Torque Base No Yes 200 Steam
Torque Wrench Yes No Single Use Not Applicable
CUSA Quick Connect
artridge and Tubing Set Yes No Single Use Not Applicable
Single Use Tip Pack (all items) Yes No Single Use -
One time prior to use Steam
EUT Tip Pack (all items) No
Tip: Yes
All other items:
No (not reusable; but
require sterilization
prior to use)
5 (EUT tip only)
Flue, stylet and
nosecone -
one time prior to use
Steam
WARNING Single-use devices are for single patient use only. Do not reprocess or re-use.