Integra LifeSciences Corporation
CUSA Surgical Aspirator Systems
CUSA Clarity System Service and Maintenance Manual
Service and Maintenance Manual
117 Pages
Preview
Page 1
CUSA® Clarity System Service and Maintenance Manual
Intentionally Blank
CUSA® Clarity System Service and Maintenance Manual
Page 2 of 117
0645403-2-EN
This document contains proprietary and confidential information of Integra LifeSciences Corporation. Integra’s confidential information may not be used, disclosed or reproduced without the prior written consent of Integra LifeSciences Corporation.
Table of Contents Chapter 1... 8 1.1 Intended Audience... 8 1.2 Intended Usage of this Manual... 8 1.3 Trademark Acknowledgments... 8 1.4 Manufacturer... 8 1.5 Patent Information... 8 1.6 System Features... 8 1.7 Overview of Manual... 9 1.8 Classification and Console Symbols... 9 1.9 Safety Information – Warnings and Cautions... 9
Chapter 2 Introduction to the CUSA® Clarity System... 13 2.1 Overview... 13 2.1.1 Fragmentation... 13 2.1.2 Irrigation... 13 2.1.3 Aspiration (Suction)... 13 2.2 Console Components and Accessories... 14 2.2.1 Touchscreen Display and Functions... 14 2.2.2 Handpiece Components... 15 2.2.3 Footswitch Component... 15
Chapter 3 Assembling the System Prior to Use... 17 3.1 Overview... 17 3.2 Assembling the Console and Cart... 17 3.3 Attaching the Power Cord... 17
Chapter 4 System Setup in the Sterile Environment... 19 4.1 Overview... 19 4.2 Assembling the Handpiece in the Sterile Environment... 19
Chapter 5 System Setup in the Non-Sterile Environment... 23 5.1 Overview... 23 5.2 Assembling the Handpiece... 23 5.3 Powering Up the System... 23 5.4 Attaching the Footswitch... 23 5.5
Attaching the Handpiece... 23
5.6
Connecting the Tubing Set... 23
CUSA® Clarity System Service and Maintenance Manual
Page 3 of 117
0645403-2-EN
This document contains proprietary and confidential information of Integra LifeSciences Corporation. Integra’s confidential information may not be used, disclosed or reproduced without the prior written consent of Integra LifeSciences Corporation.
Chapter 6 Cleaning and Sterilizing the System... 27 6.1 Overview... 27 6.2 Detaching System Components... 27 6.3 Cleaning and Sterilizing the System... 29 6.3.1 Cleaning Procedures... 30 6.3.2 Sterilizing the System... 31
Chapter 7 Maintenance and Functional Testing... 35 7.1 Overview... 35 7.2 Routine Care and Maintenance... 35 7.3 Handpiece Maintenance... 35 7.4 Disposal of the Equipment... 37 7.5 Return Equipment for Service... 37 7.6 Periodic Maintenance Schedule... 38 7.7 Visual Inspection... 38 7.8 Electrical Safety Tests... 39 7.8.1 Required Equipment and Tools... 39 7.8.2 Test Conditions... 40 7.8.3 Normalization Instructions... 40 7.8.4 Test Procedures... 40 7.8.5 Electrical Safety Test Record Assessment... 45 7.9 Functional Tests... 45 7.9.1 Test Conditions... 45 7.9.2 Required Equipment and Tools... 45 7.9.3 Test Conditions... 45 7.9.4 Test Procedures... 45 7.10 Returning the Clarity System to Use... 46
Chapter 8 Troubleshooting the System... 48 8.1 Overview... 48 8.2 Exporting Logfiles... 48 8.3 Alarm Descriptions... 48 8.4 Technical Messages... 49 8.5 General Troubleshooting... 50 8.6 Amplitude Troubleshooting... 51 8.7 Aspiration Troubleshooting... 51 8.8 Irrigation Troubleshooting... 52 8.9 Status Bar Root Causes and Solutions... 54 8.10 Error Code Matrix... 55
CUSA® Clarity System Service and Maintenance Manual
Page 4 of 117
0645403-2-EN
This document contains proprietary and confidential information of Integra LifeSciences Corporation. Integra’s confidential information may not be used, disclosed or reproduced without the prior written consent of Integra LifeSciences Corporation.
Chapter 9 Disassembly and Reassembly of Sub-Assemblies... 59 9.1 Overview... 59 9.2 Required Tools and Equipment... 59 9.3 IV Pole Replacement Ref. S30905284... 59 9.4 Disassembling CUSA® Clarity Console from Cart... 60 9.5 Assembling CUSA® Clarity Console on Cart... 61 9.6 Cart Base Plate Replacement Ref. S72905007... 63 9.7 Cart Vacuum Canister Holder Replacement Ref. S72905009... 64 9.8 Cart Foot Switch Basket Replacement Ref. S72905053... 66 9.9 Cart Cable Winding Peg Replacement Ref. S72905054... 67 9.10 Cart Caster Replacement Ref. S72905055... 68 9.11 Cart Caster Bumper Replacement Ref. S72905056... 69 9.12 Cart Weight Cover Replacement Ref. S72905051... 69
Chapter 10 Technical Specifications... 73 10.1 Console... 73 10.2 Dimensions... 73 10.3 Tip Specifications... 73 10.4 Subsystems... 73 10.5 Handpiece... 73 10.6 Electrical Requirements... 73 10.6.1 Power Input and Fusing... 73 10.6.2 Power Cords... 73 10.6.3 Maximum Low Frequency Leakage... 73 10.7 Duty Cycle... 73 10.8 Environment... 73 10.9 Voluntary Standards... 73 10.10 Guidance and Manufacturer’s Declarations... 73
CUSA® Clarity System Service and Maintenance Manual
Page 5 of 117
0645403-2-EN
This document contains proprietary and confidential information of Integra LifeSciences Corporation. Integra’s confidential information may not be used, disclosed or reproduced without the prior written consent of Integra LifeSciences Corporation.
Chapter 11 REPLACEMENT PARTS... 75 11.1 Ordering Replacement Parts... 75 11.2 Field Replacement Part list... 75 Chapter 12 Warranty... 78 12.1 Overview... 78 12.2Coverage... 78 12.3 Exclusions... 78 12.4 Service, Repairs, and Replacement... 78 12.5 Repair Parts and Services... 79 12.6 Quality Control... 79 12.7 Limitation of Liability... 80 Appendix A: Integra Global Service & Repair Test Procedures (IT0738 & IT0739) and Test Data Sheets... 83 Appendix B: Serial Number Nomenclature... 96
CUSA® Clarity System Service and Maintenance Manual
Page 6 of 117
0645403-2-EN
This document contains proprietary and confidential information of Integra LifeSciences Corporation. Integra’s confidential information may not be used, disclosed or reproduced without the prior written consent of Integra LifeSciences Corporation.
Intentionally Blank
CUSA® Clarity System Service and Maintenance Manual
Page 7 of 117
0645403-2-EN
This document contains proprietary and confidential information of Integra LifeSciences Corporation. Integra’s confidential information may not be used, disclosed or reproduced without the prior written consent of Integra LifeSciences Corporation.
Chapter 1 1.1 Intended Audience This manual provides servicing information for the CUSA® Clarity Surgical Ultrasonic Aspirator system. The manual is intended for use by a certified biomedical technician, as well as Integra authorized service partner responsible for the safe handling and maintenance of the CUSA® Clarity console.
1.2 Intended Usage of this Manual This Service and Maintenance Manual describes how to perform basic cleaning, inspection, maintenance, troubleshooting, and non-invasive repair of the CUSA® Clarity console. This manual provides specific reference materials that may be used to train new technicians in performance of functional tests, and field replacement item installation. The manual also provides functional testing procedures for operational verification of the console prior to clinical use.
1.3 Trademark Acknowledgments Integra, the Integra logo, CUSA, and Tissue Select are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. ShearTip, MicroTip, and CUSA Quick Connect are trademarks of Integra LifeSciences Corporation or its subsidiaries. Sani-Cloth is a 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. CAUTION Federal (USA) law restricts this device to sale by or on the order of a physician.
1.4 Manufacturer Integra LifeSciences (Ireland) Limited IDA Business & Technology Park Sragh Tullamore, County Offaly, Ireland Integra LifeSciences Corporation Plainsboro, NJ 08536 USA; 1-800-997-4868 © 2017 Integra LifeSciences Corporation. All Rights Reserved. Do not reproduce the contents of this publication in any form without the written permission of Integra.
1.5 Patent Information U.S. Patents 6,499,358; 8,118,823; 8,518,066; 9,421,027; additional patent(s) pending.
1.6 System Features The CUSA Clarity system includes several important components and features: • Console with touchscreen interface • Cart • 36 kHz handpiece • A variety of surgical tips that attach to the handpiece: o Sterile, single-use tips o Non-sterile, extended use tips (EUT) • Tissue Select® feature, which increases the selectivity of the surgical tip, allowing greater control and precision
CUSA® Clarity System Service and Maintenance Manual
Page 8 of 117
0645403-2-EN
This document contains proprietary and confidential information of Integra LifeSciences Corporation. Integra’s confidential information may not be used, disclosed or reproduced without the prior written consent of Integra LifeSciences Corporation.
1.7 Overview of Manual This Service and Maintenance Manual describes the safe handling, service, and maintenance of the CUSA Clarity Ultrasonic Surgical Aspirator System. It presents the CUSA Clarity as a system that includes a console, components, and accessories. It describes: • The CUSA Clarity system, components, accessories, and functions • How to assemble and setup in sterile and non-sterile environments • How to perform cleaning and sterilization • How to maintain the system • How to perform a visual inspection • How to perform functional tests • How to troubleshoot the system • Technical specifications • Warranty considerations
1.8 Classification and Console Symbols Symbol
Description
Symbol
Description
Symbol
Description
Follow Instructions for Use
Fast Flush Pedal
Non-sterile
MR Unsafe
Dispose in accordance with WEEE regulations
Recyclable packaging
This equipment meets type Cardiac Floating (CF) safety standards
Non-pyrogenic
Caution: Federal law restricts this device to sale by or on the order of a physician
High Voltage Warning
Do not re-use
Consult Instructions for Use
Ground Stud Marking
Sterilized using ethylene oxide
Product complies with the requirements of directive 93/42/EEC
System Power On/Off
Do not resterilize
Handpiece Connector
Do not use if package is damaged
Footswitch Connector
Temperature limitations
Catalogue Number
Humidity limitations
Serial Number
This product is not manufactured with Dry Rubber or Natural Rubber Latex
Date of Manufacture
Lot number
Manufacturer
Expiration date
Amplitude Pedal
Keep dry
CUSA® Clarity System Service and Maintenance Manual
Page 9 of 117
0645403-2-EN
This document contains proprietary and confidential information of Integra LifeSciences Corporation. Integra’s confidential information may not be used, disclosed or reproduced without the prior written consent of Integra LifeSciences Corporation.
1.9 Safety Information – Warnings and Cautions To promote the safe use of the CUSA Clarity system, this section lists the warnings and cautions that appear throughout this Service and Maintenance Manual. To operate this equipment with maximum safety, it is important to read, understand, and follow the instructions in these warning and cautions. This manual also includes Notes to aid the technician in maintenance, handling, and use of the system.
Conventions Used in this Guide To draw immediate attention to matters of importance, this manual presents Warnings, Cautions, and Notes. WARNING Indicates a potentially hazardous situation that, if not avoided, could result in serious injury or death. CAUTION Indicates a hazardous situation that, if not avoided, could result in product damage. Note Indicates additional information. WARNING To avoid risk of electric shock, connect all equipment to a grounded power source. WARNING Before use, sterilize the torque base in the sterilization tray with the handpiece. WARNING Do not use a damaged handpiece with the CUSA Clarity system. This may result in injury to the patient or user. WARNING To ensure sterility, assemble sterile handpiece and tip in the sterile field only.
WARNING To avoid injury to the user, keep fingers away from the peristaltic pump and pinch valve. WARNING When measuring equipment leakage current of Class I ME equipment, an interruption of the grounding connection endangers system technicians and bystanders. WARNING Electric Shock Hazard - Always unplug the CUSA Clarity System before cleaning or sterilizing it. WARNING Bio-hazardous waste may be present. Do not perform service procedures on the console, handpiece and foot-pedal or its cables or components until all have been decontaminated. WARNING Do not allow fluids to enter the console.
WARNING Single-use devices are for single patient use only. Do not reprocess or re-use. CUSA® Clarity System Service and Maintenance Manual
Page 10 of 117
0645403-2-EN
This document contains proprietary and confidential information of Integra LifeSciences Corporation. Integra’s confidential information may not be used, disclosed or reproduced without the prior written consent of Integra LifeSciences Corporation.
WARNING To avoid injury or damage to equipment, place system in standby mode prior to changing tip or clearing a clog. WARNING Turn off the power before opening the console - disconnect the power cord. CAUTION Federal (USA) law restricts this device to sale by or on the order of a physician. 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. CAUTION Only use the cleaning agents listed in the section for cleaning and disinfecting the console. Using solvents or cleaning agents not listed in the guidelines may damage the plastic exterior of the console. CAUTION Do not use sterilization methods involving temperatures in excess of 134ºC (273.2°F) as this may damage the handpiece.
CAUTION Only an authorized Integra engineer should open the console.
CAUTION The CUSA Clarity console weight is 29.5 kg (65 lbs). Make sure only individuals who are capable of safely lifting 29.5kg (65 lbs.) lift the console.
CAUTION Lock all four casters before taking of the console from the cart.
CAUTION Avoid contact between the CUSA Clarity surgical tip and an activated monopolar surgical instrument. CAUTION High frequency surgical equipment can affect the function of medical electrical devices such as ultrasonic aspirators. When using monopolar high frequency surgical equipment simultaneously with the CUSA Clarity system, contact between the activated monopolar electrosurgery instrument and the CUSA Clarity surgical tip could affect system functionality. Avoid contact between the CUSA Clarity surgical tip and an activated monopolar surgical instrument.
CUSA® Clarity System Service and Maintenance Manual
Page 11 of 117
0645403-2-EN
This document contains proprietary and confidential information of Integra LifeSciences Corporation. Integra’s confidential information may not be used, disclosed or reproduced without the prior written consent of Integra LifeSciences Corporation.
Intentionally Blank
CUSA® Clarity System Service and Maintenance Manual
Page 12 of 117
0645403-2-EN
This document contains proprietary and confidential information of Integra LifeSciences Corporation. Integra’s confidential information may not be used, disclosed or reproduced without the prior written consent of Integra LifeSciences Corporation.
Chapter 2 - Introduction to the CUSA® Clarity System 2.1 Overview This section provides general information about the CUSA® Clarity Ultrasonic Surgical Aspirator System: what it is, what it does, and how it works. The system is an ultrasonic surgical aspirator system that allows a surgeon to remove tissue efficiently and selectively. It performs three functions: fragmentation, irrigation, and aspiration.
2.1.1 Fragmentation The console supplies the high-frequency handpiece with an alternating voltage signal at 36,000 cycles per second (36 kHz). This voltage moves to opposite poles of a stack of piezoelectric ceramic discs fastened to the metallic body inside the handpiece. The resulting oscillating electric field causes the discs to vibrate. This vibration transitions down the length of the metallic body and into the surgical tip. The slender, tapered shape of the surgical tip focuses the vibrational energy at the tip of the handpiece. Fragmentation occurs when the vibrating tip meets the tissue, causing the tissue to break apart. Note All three functions may occur at the same time.
2.1.2 Irrigation The system transfers irrigation fluid from a user-supplied IV saline or Lactated Ringer’s solution to the distal tip of the handpiece. Sterile irrigation fluid flows from an IV set (bottle or bag and IV administration tubing) to a variable speed peristaltic pump. The pump: • Moves fluid at 2 to 20 mL/min; default flow is 3 mL/min. Use the adjustment slider (move the slider up/down on the Irrigation column on the touch screen) to increase or decrease the irrigation flow in 1 mL/min increments. • Accelerates to a Fast Flush speed, pumping at 25 mL/min ± 0.5 mL/min. The Fast Flush pedal on the system footswitch activates the Fast Flush feature. The pump pushes the fluid through the manifold irrigation tubing to a flue, a sleeve surrounding the vibrating tip. As the irrigation fluid passes through the flue, it cools the tip. When the fluid reaches the distal end of the tip, as much as 99% of it passes through two pre-aspiration holes in the tip, preventing fluid pooling in the sterile field and continually clearing the suction system. Fluid that does not pass through the pre-aspiration holes irrigates the surgical site and suspends fragmented tissue.
2.1.3 Aspiration (Suction) Aspiration enables Constant Tissue Contact, the consistent, tangible contact between tip and tissue, which is essential in efficient tissue resection. A vacuum pump in the console provides nominally 640mmHg maximum dead head vacuum at sea level. Use the adjustment buttons (move the slider up/ down on the Aspiration column on the touchscreen display) to increase or decrease the suction from 10 to 100% in 5% increments; default is 60%. The suction, which produces an air stream moving toward the vacuum pump, pulls irrigation fluid, fragmented tissue, and other materials through the distal end of the surgical tip. From the tip, the aspirated materials pass through the handpiece and manifold suction tubing into the suction canister. From the suction canister, the air stream continues to flow through a contamination guard that filters any remaining particulate matter or moisture, preventing them from entering the vacuum pump. The accuracy of the vacuum level in the aspiration tubing at the port of the handpiece is ± 66 mmHg and never less than 30 mmHg. A suction pinch valve on the front of the console opens when the system is on, and closes to stop suction when: • Priming the irrigation system • Pressing the Fast Flush pedal • Releasing the amplitude pedal in Run Status (in this case, the pinch valve closes for approximately one second, then re-opens). • Releasing the amplitude pedal in the on demand aspiration mode, this suction stoppage prevents depletion of the pneumoperitoneum. When powered off, the system’s suction pump remains off and the suction pinch valve remains closed. Use the pinch value button on the front of the suction pinch valve to open the valve manually CAUTION High frequency surgical equipment can affect the function of medical electrical devices such as ultrasonic aspirators. When using monopolar high frequency surgical equipment simultaneously with the CUSA Clarity system, contact between the activated monopolar electrosurgery instrument and the CUSA Clarity surgical tip could affect system functionality. Avoid contact between the CUSA Clarity surgical tip and an activated monopolar surgical instrument.
CUSA® Clarity System Service and Maintenance Manual
Page 13 of 117
0645403-2-EN
This document contains proprietary and confidential information of Integra LifeSciences Corporation. Integra’s confidential information may not be used, disclosed or reproduced without the prior written consent of Integra LifeSciences Corporation.
2.2 Console Components and Accessories This section describes the console and optional cart for the CUSA Clarity Ultrasonic Surgical Aspirator System. It describes the major subsystem components and accessories of the console.
Console Features The figure illustrates the console on the optional cart. The components are described in the table.
➀ ➁
➄
➂ ➃
➅
Component
Description
➀
Console Body
Houses the electronics, pumps, and mechanical parts. It includes a touchscreen that allows you to control the functions of the system.
➁
Handpiece Connector
Connector to plug in the surgical handpiece.
➂
Contamination Guard
The filter and tubing that connects between the canister and the console. This assembly filters any remaining particulate matter or moisture, preventing them from entering the vacuum pump.
➃
Canister Holder
Holder for user-supplied aspiration canister.
➄
AC Mains Connector and Cable
Cable that plugs into a wall receptacle to provide power to the system.
➅
Footswitch
A device connected to the console that includes two pedals used to control the amplitude and irrigation fluid.
CUSA® Clarity System Service and Maintenance Manual
Page 14 of 117
0645403-2-EN
This document contains proprietary and confidential information of Integra LifeSciences Corporation. Integra’s confidential information may not be used, disclosed or reproduced without the prior written consent of Integra LifeSciences Corporation.
Console – Front Panel The figure illustrates the front view of the console. The components are described in the table.
➀
➁ ➅ ➃ ➄
➂
Component
Description
➀
Power Button
Powers the system on and off.
➁
Handpiece Cable Connector
Connects the handpiece to the console.
➂
Contamination Guard Connector
Connects the contamination guard filter to the console.
➃
Suction Pinch Valve
When closed, the valve pinches off suction flow to the handpiece when: Priming the handpiece with irrigation fluid Pressing the Fast Flush pedal Releasing the amplitude pedal in Run Status Releasing the amplitude pedal in the on demand aspiration mode When the system is powered off, the suction pinch valve remains closed. Use the suction pinch valve release button to open the valve.
➄
Suction Pinch Valve Release Button
Opens the suction pinch valve manually.
➅
Irrigation Door
Open to connect cartridge. Protects irrigation pump head.
CUSA® Clarity System Service and Maintenance Manual
Page 15 of 117
0645403-2-EN
This document contains proprietary and confidential information of Integra LifeSciences Corporation. Integra’s confidential information may not be used, disclosed or reproduced without the prior written consent of Integra LifeSciences Corporation.
Console – Rear Panel The figure illustrates the rear view of the console. The components are described in the table.
➀
➇ ➆
➁
➅ ➄ ➃ ➂ Component
Description
➀
System Fan Vent
Fan keeps internal system cool.
➁
Potential Equalization Terminal
For use in locations where Potential Equalization Conductors are used.
➂
Footswitch Cable Connector
Connects the footswitch to the console.
➃
AC Power Cord Connector
Connects the system to the Mains power supply. A safety feature prevents the power cord from being accidentally unplugged.
➄
Fuses
Protect the system from electrical overloads.
➅
Labels
Displays the console model number, serial number and regulatory approvals.
➆
USB Connector
Used for service
➇
I.V. Pole
Supports the sterile irrigation fluid container. The pole must be raised to use it. The pole can be lowered when not in use. The safe working load for the I.V. pole is 2 kg.
CUSA® Clarity System Service and Maintenance Manual
Page 16 of 117
0645403-2-EN
This document contains proprietary and confidential information of Integra LifeSciences Corporation. Integra’s confidential information may not be used, disclosed or reproduced without the prior written consent of Integra LifeSciences Corporation.
2.2.1 Touchscreen Display and Functions The Touchscreen layout consists of the Main Screen, Setup Tasks Screen, Settings Screen, and Online Help Screen.
Main Screen To access the Main Screen, press the Main Screen button from any other screen. The Main Screen contains ultrasonic control scales for amplitude, Tissue Select® feature, aspiration, and irrigation, slide buttons for the footswitch and aspiration modes, and buttons to open the setup tasks, settings, and online Help screens.
➀
➁
➂
➃
➄
➈
➇
➆
➅
➀
Amplitude Control Scale
➅
Online Help Button
➁
Tissue Select Control Scale
➆
Settings Button
➂
Aspiration Control Scale
➇
Setup / Standby Button
➃
Irrigation Control Scale
➈
Footswitch Mode Slide Button
➄
Aspiration Mode Slide Button
The Settings Screen contains a listing of available languages and systems information. The system information provides the software, IB firmware, UM firmware, UC firmware, operating system version numbers, and the device serial number. There is also an Extract Log button to download system log files for service help.
CUSA® Clarity System Service and Maintenance Manual
Page 17 of 117
0645403-2-EN
This document contains proprietary and confidential information of Integra LifeSciences Corporation. Integra’s confidential information may not be used, disclosed or reproduced without the prior written consent of Integra LifeSciences Corporation.
2.2.2 Handpiece Components The CUSA® Clarity handpiece is a hand-held surgical device. It houses a transducer that vibrates at an ultrasonic frequency, transferring the vibrations to a hollow titanium tip. When applied to patient tissue, the vibrating tip provides the desired surgical effect – the fragmentation and removal of specific tissue. The handpiece connects to the console by a handpiece cable and by the CUSA Quick Connect™ Cartridge and Tubing Set.
Components of Assembled Handpieces
➁ ➂ ➀
➃ ➄ ➅
➇ ➆
➀
Handpiece Body
➄
Tip
➁
Handpiece Cable with Connector
➅
Nosecone
➂
Aspiration Port
➆
Flue
➃
Handpiece Connecting Body
➇
Flue Luer Lock Fitting
Handpiece The handpiece body contains: • Transducer to convert electric energy into mechanical motion • Aspiration port to connect the aspiration tubing to the handpiece The handpiece cable contains: • Electric wires (deliver electric power from console to drive the handpiece) • Connector that attaches the handpiece cable to the console The connecting body serves as the connecting point for the tip and transfers the vibrations from the transducer to the tip.
CUSA® Clarity System Service and Maintenance Manual
Page 18 of 117
0645403-2-EN
This document contains proprietary and confidential information of Integra LifeSciences Corporation. Integra’s confidential information may not be used, disclosed or reproduced without the prior written consent of Integra LifeSciences Corporation.
Tip ➁
➀
The tip is a hollow titanium tube that touches patient tissue. When active, the tip vibrates at an ultrasonic frequency, causing it to fragment tissue. The tip has two pre-aspiration holes ➀, one on either side, which help to keep the tip clear and provide better visibility at the surgical site. Threads ➁ on the end of the tip are for attaching the tip to the connecting body of the handpiece. The tip is sterile and single use when in a sterile tip pack or can be used up to five (5) times if it is an extended use tip (EUT).
Nosecone
The single-use nosecone attaches to the handpiece, covers the connecting body, and holds the flue in place. It is sterile in a single use tip pack and nonsterile in an EUT pack.
Integrated O-rings The o-rings are integrated into the nosecone. They provide stability for the nosecone and prevent fluid leaks into the connecting body.
CUSA® Clarity System Service and Maintenance Manual
Page 19 of 117
0645403-2-EN
This document contains proprietary and confidential information of Integra LifeSciences Corporation. Integra’s confidential information may not be used, disclosed or reproduced without the prior written consent of Integra LifeSciences Corporation.
Flue
The single-use flue is a translucent silicone tube tapered at one end that provides a sleeve over the tip. Irrigation fluid flows through an irrigation connection tube at one end of the flue and down the tip to the surgical site. The single-use flue is sterile in a single use tip pack and nonsterile in an EUT pack. Each tip size requires a tip-specific flue; therefore, you will find the tip-specific flue packaged with the appropriate tip.
Additional Handpiece Components These components are essential in assembling a handpiece.
CUSA Quick Connect™ Cartridge and Tubing Set (Sterile) ➂
➀
➁
A single-use sterile cartridge and tubing kit that includes the aspiration tubing➀, irrigation tubing ➁ and a cartridge➂.
CUSA® Clarity System Service and Maintenance Manual
Page 20 of 117
0645403-2-EN
This document contains proprietary and confidential information of Integra LifeSciences Corporation. Integra’s confidential information may not be used, disclosed or reproduced without the prior written consent of Integra LifeSciences Corporation.