Integra CUSA Clarity Configuration guide

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

Integra®CUSA®Clarity – Ultrasonic Surgical Aspirator System
Cleaning Instruction Guide
PREFACE
Intended Audience
This operator’s manual and the equipment it describes are for use only by qualified medical professionals trained in the particular
technique and surgical procedure to be performed. It is intended as a guide for using the CUSA® Clarity Ultrasonic Surgical Aspirator
System only.
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
1
2

3
Integra®CUSA®Clarity – Ultrasonic Surgical Aspirator System
Cleaning Instruction Guide
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 con-
taminated 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.
23 kHz 36 kHz 23 kHz 36 kHz
23 kHz 36 kHz
23 kHz 36 kHz
23 kHz 36 kHz
23 kHz 36 kHz
23 kHz 36 kHz

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
Cleaning Instruction Guide
Detaching the Contamination Guard
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 powered down.
Cleaning the System
Cleaning the Console, Touchscreen, and Cart surfaces
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 Never spray any cleaner directly onto
the touch screen.
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
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.
WARNING Do not allow fluids to enter the console.
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.

6
Cleaning the Handpiece, EUT, Sterilization Tray, and Torque Base
The handpieces, extended use tips, sterilization tray, and torque base may be cleaned by either the manual cleaning or autowash
cycle process prior to sterilization. For Sterilization Parameters, see “Sterilizing the System” on page 8.
Manual Cleaning
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.
1. Clean the exterior of the handpiece and tip with a lint free cloth soaked with warm water and a non-alkaline detergent.
2. Use the cloth to manually clean the junction where the tip aaches.
3. Rinse the entire handpiece and tip thoroughly with water and dry with a so cloth.
Cleaning Brush
The CUSA Clarity Cleaning Brush is intended to be used primarily to clean the internal pathways, as needed, of the CUSA Clarity
handpiece following use, during the manual cleaning process or as the first step of the automated cleaning process, just prior to
autowashing.
The CUSA Clarity cleaning brush is provided non-sterile and is not intended for use in a sterile environment. It is intended to be used
and stored only in the reprocessing unit of the healthcare facility.
Automated Cleaning:
Before automated cleaning, use the provided cleaning brush, dipped in cold tap water, 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. Rinse the exterior and in-
terior of the tip in cold running tap water for 30 seconds. For initial exterior cleaning of each component, prepare a cleaning solution
using a neutral or mid-alkaline detergent in accordance with the manufacturer’s instructions. Using lint-free cloths soaked in the
prepared cleaning solution, wipe clean each component.
• In a Steelco DS50 DRS or equivalent washer /disinfector:
• Perform a prewash cycle of 5 minutes at 43°C.
• Perform a cleaning cycle using a mid-alkaline pH detergent
(pH 10.0 – pH 11.5) for 10 minutes at 60°C. Prepare the detergent solution according to the manufacturer’s recommenda-
tions.
• Perform a disinfection cycle for 10 minutes at 93°C.
• Dry for 20 minutes at 55°C.
NOTE Do not clean the sterilizer tray with abrasives. Product damage will result.
NOTE Do not submerge the handpiece cable connector.

7
Integra®CUSA®Clarity – Ultrasonic Surgical Aspirator System
Cleaning Instruction Guide
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.
NOTE Do not submerge the footswitch connector.

8
Sterilizing the System
Packaging the Handpiece and Components for Sterilization
The handpiece and components need to be packaged for sterilization. Integra provides a 23 kHz and 36 kHz sterilization tray for each
of its corresponding handpieces
The provided trays are intended to protect the CUSA Clarity Handpiece, EUT, and Torque Base during steam sterilization and during
transfer to the sterile field. The handpiece and components must be cleaned prior to sterilization, see “Cleaning the Handpiece, EUT,
Sterilization Tray, and Torque Base” on page 6.
Sterilization Tray Layout
➀Handpiece ➄Flue and Stylet
➁Handpiece Cable Posts ➅Torque Base
➂Handpiece Connector ➆EUT Slots (3)
➃Nosecone ➇Lid (Not shown)
23 kHz Sterilization Tray Layout 36 kHz Sterilization Tray Layout
➀
➁
➂
➄
➅
➆
➀
➁
➂
➃
➅
➆
➃

9
Integra®CUSA®Clarity – Ultrasonic Surgical Aspirator System
Cleaning Instruction Guide
Most Common Sterilization Tray Configuration
EUT Sterilization Tray Configuration
1. Place the handpiece in the appropriate slot ➀.
2. Wrap the handpiece cable around the posts ➁.
3. Place the handpiece connector in the appropriate slot ➂.
4. Optional. Place the nosecone in the appropriate slot ➃.
5. Optional. Place the flue ➄ anywhere on the boom of the tray.
6. Place the torque base in the appropriate slot ➅.
7. Optional. Place the Extended Use Tips (up to 3) in the appropriate slots ➆.
8. Put on the lid ➇ on the sterilizer tray.
9. Close and latch the lid.

10
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
• Immediate-Use Steam Sterilization / Flash (Unwrapped) — Sterilization tray unwrapped
The cycles below were validated for sterilizing the CUSA Clarity handpiece and components:
Packaging Temperature Type Time Dry Cycle
Wrapped
132˚C (269.6˚F) Prevac 4 min 40 min
134˚C (273.2˚F) Prevac 3 min 40 min
134˚C (273.2˚F) Prevac 18 min 40 min
Immediate-Use Steam
Sterilization / Flash
(Unwrapped)
132˚C (269.6˚F) Prevac 4 min None
Sterilization Cycles for the 23 kHz and 36 kHz Handpiece and Components
CAUTION Do not sterilize flues with temperatures in excess of 134ºC (273.2°F)
as this may damage the flue.
The CUSA Clarity handpieces and components can be effectively
sterilized with alternate cycles between the ranges of the validated
sterilization cycles outlined in the tables above. If an alternative
sterilization cycle is used, it is recommended that the reprocessor
ensures use of FDA cleared sterilizers and accessories for the alter-
native sterilization cycle.
The figure to the right illustrates the endpoints of the steam
sterilization cycles that have been validated to achieve effective
sterilization. Cycles that fall outside of the shaded gray area have
not been validated.
Sterilization Temperature (°C)
Sterilization Time (min)
3 3.5 4 18
132
133
134
135
136
137

Integra®CUSA®Clarity – Ultrasonic Surgical Aspirator System
Cleaning Instruction Guide
USA 800-654-2873
n
888-980-7742 fax
International [phone]
n
[phone] fax
integralife.com/contact
United States, Canada, Asia, Pacific, Latin America
Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.
n
Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.
n
Warning: Applicable laws restrict these products to sale by or on the order of a physician.
n
Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.
For more information or to place an order, please contact:
Integra, the Integra logo, and CUSA are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. CUSA Quick Connect
is a trademark of Integra LifeSciences Corporation or its subsidiaries. Sani-Cloth is a registered trademark of Professional Disposables International, Inc. neodisher is a trademark
of Chemische Fabrik Dr. Weigert GmbH & Co. KG. All other trademarks and trade names are the property of their respective owners. ©2019 Integra LifeSciences Corporation.
All rights reserved. Printed in USA. 0M 0932889-3-EN
Integra LifeSciences (Ireland) Limited
IDA Business &Technology Park
Sragh
Tullamore
County Offaly
Ireland
Manufacturer:
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
137°C (278.6°F).
CAUTION Do not use sterilization methods involving temperatures in
excess of 137ºC (278.6°F) as this may damage the handpiece.
CAUTION Do not sterilize flues with temperatures in excess of 134°C
(273.2°F) as this may damage the flue.