CUSA Clarity 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

F ederal (USA) law restricts this device to sale by or on the order of a physician.

Disassembling the System CUSA® Clarity Items to Keep and Discard After a Surgical Procedure Keep

Discard

Handpiece

Nosecone

Contamination Guard

Flue

EUTs (with less than 5 uses)

EUTs (after 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

Disassembling the Handpiece

1

2

1. Remove the irrigation tubing from the clip at the base of the handpiece.

2. Remove the handpiece cable from the aspiration tubing clips.

3. Remove the aspiration tubing from the aspiration port at the base of the handpiece.

4. Remove the irrigation tubing from the Luer fitting on the handpiece flue. 2

Integra® CUSA® Clarity – Ultrasonic Surgical Aspirator System Cleaning Instruction Guide 5. Slide the flue off of the nosecone base along the tip. 23 kHz

36 kHz

23 kHz

36 kHz

23 kHz

9. Hold the handpiece in the base and place the torque wrench (color side towards handpiece) over the tip.

36 kHz

10. Rotate the torque wrench counter-clockwise. 23 kHz

23 kHz

36 kHz

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.

7. Slide the nosecone off the tip. 23 kHz

6. Twist off the nosecone counter-clockwise until it unlocks.

36 kHz

36 kHz

To avoid product damage, always use the torque base

CAUTION to hold the handpiece while using the torque wrench to tighten or loosen the tip. Avoid over torqueing the tip.

11. Unthread the tip from the handpiece connecting body by turning the tip counter-clockwise by hand. 23 kHz

3

36 kHz

12. Discard the items (listed in the table in “CUSA® Clarity Items to Keep and Discard After a Surgical Procedure” on page 2) in compliance with hospital policy for contaminated waste.

Disassembling the Console

1. Detach the aspiration tubing from the patient port on the canister.

2. Disconnect the contamination guard tubing from the vacuum port of the canister.

NOTE

3. Open cartridge door, if necessary press the pinch valve button, and remove the cartridge from the console by sliding it up.

5. Unplug the power cord from the wall receptacle and the console.

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).

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.

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 After a Surgical Procedure” on page 2. 4

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

Detaching the Contamination Guard 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).

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 button on the front of the console. The touchscreen will go dark. Do not unplug power cord until system has powered down.

Cleaning the System Electric Shock Hazard - Always unplug

WARNING the CUSA Clarity System before cleaning it. NOTE

Product damage may result if you do not follow the

CAUTION instructions described in the cleaning section.

Never spray any cleaner directly onto the touch screen.

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.

WARNING Do not allow fluids to enter the console. 4. Clean the wheels at the base of the system cart to ensure that the four anti-static wheels function correctly.

NOTE

5

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.

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.

NOTE

Do not submerge the handpiece cable connector.

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 attaches. 3. Rinse the entire handpiece and tip thoroughly with water and dry with a soft 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 interior 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 recommendations. • 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.

6

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.

NOTE

Do not submerge the footswitch connector.

4. Allow the footswitch to drain after rinsing.

7

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 23 kHz Sterilization Tray Layout

➂

36 kHz Sterilization Tray Layout

➅

➅

➂

➆ ➁

➁ ➄ ➆

➃

➀

➃

➀

➀

Handpiece

➄

Flue and Stylet

➁

Handpiece Cable Posts

➅

Torque Base

➂

Handpiece Connector

➆

EUT Slots (3)

➃

Nosecone

➇

Lid (Not shown)

8

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 bottom 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.

9

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: •W  rapped-Sterilization tray double wrapped in hospital CSR material • I mmediate-Use Steam Sterilization / Flash (Unwrapped) - Sterilization tray unwrapped The cycles below were validated for sterilizing the CUSA Clarity handpiece and components:

Sterilization Cycles for the 23 kHz and 36 kHz Handpiece and Components

Sterilization Cycles for the 23 kHz and 36 kHz Handpiece and Components

30-Minute Dry Cycle

40-Minute Dry Cycle

Packaging

Wrapped

ImmediateUse Steam Sterilization / Flash (Unwrapped)

Time

Dry Cycle

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

Temperature

Type

132˚C (269.6˚F) Prevac 4 min

None

Packaging

Time

Dry Cycle

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

Temperature

Wrapped

ImmediateUse Steam Sterilization / Flash (Unwrapped)

Type

132˚C (269.6˚F) Prevac 4 min

None

CAUTION Do not sterilize flues with temperatures in excess of 134ºC (273.2°F) as this may damage the flue.

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 Time (min)

Sterilization Temperature (°C)

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 alternative sterilization cycle.

3

3.5

4

18

132 133 134 135 136 137

10

Integra® CUSA® Clarity – Ultrasonic Surgical Aspirator System Cleaning Instruction Guide 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 sterilizing, 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). Do not use sterilization methods involving temperatures in

CAUTION excess of 137ºC (278.6°F) as this may damage the handpiece. Do not sterilize flues with temperatures in excess of 134°C

CAUTION (273.2°F) as this may damage the flue.

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. Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality. Warning: Applicable laws restrict these products to sale by or on the order of a physician. Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use. n n n

For more information or to place an order, please contact: United States, Canada, Asia, Pacific, Latin America USA 800-654-2873 888-980-7742 fax International +1 609-936-5400 +1 609-750-4259 fax integralife.com/contact n

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Manufacturer: Integra LifeSciences (Ireland) Limited IDA Business &Technology Park Sragh Tullamore County Offaly Ireland

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. ©2021 Integra LifeSciences Corporation. All rights reserved. Printed in USA. 0M 0932889-4-EN