CUSA Clarity System Service and Maintenance Manualation. CUSA® Clarity System Service and Maintenance Manual Page 3 of 117 0645403-2-EN Chapter 1..... ..... 8

CUSA® Clarity SystemService and Maintenance Manual

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.

CUSA® Clarity System Service and Maintenance Manual Page 2 of 117 0645403-2-EN

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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

Table of Contents



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



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



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

12.2 Coverage ................................................................................................................................................................................................................ 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



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Chapter 1

1.1 Intended AudienceThis 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 ManualThis 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 AcknowledgmentsIntegra, 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.

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

1.4 ManufacturerIntegra 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 InformationU.S. Patents 6,499,358; 8,118,823; 8,518,066; 9,421,027; additional patent(s) pending.

1.6 System FeaturesThe 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



1.7 Overview of ManualThis 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

Follow Instructions for Use

MR Unsafe

This equipment meets type Cardiac Floating (CF) safety standards

High Voltage Warning

Ground Stud Marking

System Power On/Off

Handpiece Connector

Footswitch Connector

Catalogue Number

Serial Number

Date of Manufacture

Manufacturer

Amplitude Pedal

Symbol Description

Fast Flush Pedal

Dispose in accordance with WEEE regulations

Non-pyrogenic

Do not re-use

Sterilized using ethylene oxide

Do not resterilize

Do not use if package is damaged

Temperature limitations

Humidity limitations

This product is not manufactured with Dry Rubber or Natural Rubber Latex

Lot number

Expiration date

Keep dry

Symbol Description

Non-sterile

Recyclable packaging

Caution: Federal law restricts this device to sale by or on the order of a physician

Consult Instructions for Use

Product complies with the requirements of directive 93/42/EEC



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 GuideTo draw immediate attention to matters of importance, this manual presents Warnings, Cautions, and Notes.

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.

CAUTION

Indicates a hazardous situation that, if not avoided, could result in product damage.

WARNING

To avoid risk of electric shock, connect all equipment to a grounded power source.

WARNING

Indicates a potentially hazardous situation that, if not avoided, could result in serious injury or death.

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.

NoteIndicates additional information.



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.



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NoteAll three functions may occur at the same time.

Chapter 2 - Introduction to the CUSA® Clarity System

2.1 OverviewThis 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 FragmentationThe 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.

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.

2.1.2 IrrigationThe 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



➀

➁

➂

➃

2.2 Console Components and AccessoriesThis 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 FeaturesThe figure illustrates the console on the optional cart. The components are described in the table.

➄

➅

Component Description

➀ Console BodyHouses 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 GuardThe 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.

➄AC Mains Connector and Cable

Cable that plugs into a wall receptacle to provide power to the system.

➅ FootswitchA device connected to the console that includes two pedals used to control the amplitude and irrigation fluid.




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 fluidPressing the Fast Flush pedalReleasing the amplitude pedal in Run StatusReleasing the amplitude pedal in the on demand aspiration modeWhen 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.

Console – Front PanelThe figure illustrates the front view of the console. The components are described in the table.

➀

➁

➂➃➄

➅



Console – Rear PanelThe figure illustrates the rear view of the console. The components are described in the table.


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 ConnectorConnects 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. PoleSupports 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.

➀

➁

➂

➃➄

➅

➆

➇



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.

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 ScreenTo 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

➅➆➇

➈

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



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

HandpieceThe 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.

➀

➁

➂

➃

➄

➅

➆

➇

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



Tip➁

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).

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.

➀

Nosecone



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)

A single-use sterile cartridge and tubing kit that includes the aspiration tubing➀, irrigation tubing ➁ and a cartridge➂.

➀ ➁

➂



Torque Wrench (Sterile)

The single-use sterile torque wrench is used to attach or remove a tip to the handpiece.

Torque Base (Sterilizable)

The reuseable torque base is used to hold the handpiece securely in place while using the torque wrench to attach or remove a tip. The torque base is sterilizable.

Aspiration Tubing • Aspirates away used irrigation fluid, fragmented tissue, and other aspirated materials to the canister

• Connects to the aspiration port at the base of the handpiece, passes through the suction pinch valve, and connects to the aspiration port on the canister

• Contains a small clip to attach to the handpiece cable

Irrigation Tubing • Provides irrigation during the surgical procedure

• Connects to the flue, passes over the peristaltic pump, and connects to a standard IV bag, which can be hung on the console’s IV pole

Cartridge • Connects the aspiration and irrigation tubing to the console

WARNINGSingle-use devices are for single patient use only. Do not reprocess or re-use.



2.2.3 Footswitch Component The Footswitch controls the level of power to the handpiece from pressure applied to the footswitch.

Attaching the FootswitchAlign the red dot on the footswitch cable connector with the red dot on the footswitch port on the rear of the console and plug in the footswitch cable.



Chapter 3 - Assembling the System Prior to Use

3.1 OverviewThis section describes how to assemble the console and cart, and to attach the power cord.

3.2 Assembling the Console and Cart1. Place the console on the cart by aligning the four (4) feet on the bottom of the console with the four (4) indentations on the cart.

2. Seat the console squarely top of the cart.



3. Under the top of the cart, insert and turn counter-clockwise the provided screw.

3.3 Attaching the Power Cord

1. Plug the power cord into the back of the console.

2. Plug the plug end into the wall receptacle.

Note

Make sure you position the console so that you can quickly access the power cord in case you need to disconnect it.

WARNING

To avoid risk of electric shock, connect all equipment to a grounded power source.



Chapter 4 - System Setup in the Sterile Environment4.1 OverviewThis section describes the steps for setting up the CUSA® Clarity System in the sterile field. It begins with the arrival of the sterilized handpiece and accessories in the operating room, and ends with the handpiece being ready for connection to the console.

4.2 Assembling the Handpiece in the Sterile Environment

Attaching a Tip

1. Thread a tip onto the handpiece connecting body by turning the tip clockwise until it is finger tight.

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.

Place the torque base on a flat surface or in the designated spot in the sterilization tray.

Sterilize the tip for EUT use – do not exceed five uses. Sterilize each nosecone, flue, and stylet before use – dispose of each after use.

2. Place the handpiece into the torque base as shown and place the flat metal sides of the handpiece snugly in the metal slot at the end of the base.

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



Note

Keep the torque wrench and base in the sterile field in case you need to change a tip during the procedure and for disassembly after surgery.

Attaching the Nosecone and the Flue 1. Align the white dots by sliding the larger end of the nosecone over the tip and slide it down over the neck of the handpiece.

CAUTION


4. Rotate the torque wrench clockwise until it clicks twice.

2. Rotate the nosecone clockwise until it locks into place and the white dot on the nosecone aligns with the while dot on the body of the handpiece.

Align the white dots on the nosecone and handpiece for proper usage.

Remove stylet from the flue and put it aside in the sterile field if needed to clear the tip during surgery.



Note

When the pre-aspiration holes are completely covered, most of the irrigation fluid may aspirate back through the handpiece, impairing cavitation; thus reducing tissue ablation efficacy.

Attaching the Tubing1. Open the CUSA Quick Connect™ Cartridge and Tubing Set using proper sterile technique.

3. Slide the flue onto the nosecone base along the tip.

4. Align the flue with the pre-aspiration holes at the distal end of the tip.



2. Assemble the larger loop of the irrigation and aspiration tubing set to the handpiece.

3. Place the cartridge and smaller loop of the irrigation and aspiration tubing set aside until it is time to connect it to the console.

4. Attach the aspiration tubing to the aspiration port at the base of the handpiece.



5. Attach the irrigation tubing to the lock fitting on the handpiece flue.

Note

When the pre-aspiration holes are completely covered, most of the irrigation fluid may aspirate back through the handpiece, impairing cavitation; thus reducing tissue ablation efficacy.

6. Push the irrigation tubing into the clip at the base of the handpiece.

Note

Do not insert the handpiece cable into the clip at the base of the handpiece.



7. Clip the handpiece cable to the aspiration tubing using clips available along the aspiration tubing.

8. Keep sufficient tubing and cable in the sterile field to allow you to reposition the console.

9. Pass off the cartridge and smaller loop of the irrigation and aspiration tubing set and handpiece cable connector outside of the sterile field.



Chapter 5 - System Setup in the Non-Sterile Environment

5.1 OverviewThis section describes the steps for setting up the CUSA® Clarity System in the non-sterile environment.

5.2 Assembling the HandpieceAssemble the handpiece in a non-sterile environment - see System Setup in the Sterile Field (Section 4.2).

5.3 Powering Up the System Press the System Power On/Off button on the console (Classification and Console Symbols). The console sounds a startup tone.

5.4 Attaching the Footswitch Align the red dot on the footswitch cable connector with the red dot on the footswitch port on the rear of the console and plug in the footswitch cable.

WARNINGTo ensure sterility, assemble handpiece and tip in a sterile environment.

Note

The purpose of the startup tone verifies that the audio alarms are functioning correctly. If this tone does not sound during the startup process, contact Integra for service.



1. Place the canister into the canister holder.

2. Open the cartridge door, insert the cartridge, and slide the cartridge down.

Note

Do not insert the handpiece cable into the clip at the base of the handpiece.

Note

Properly set and connect the handpiece and contamination guard. See the contamination guard instructions for use for information.

5.5 Attaching the Handpiece Pass out the handpiece cable connector from the sterile environment, align the red dot on the handpiece cable connector with the red dot on the handpiece port on the front of the console, and plug in the handpiece cable.

5.6 Connecting the Tubing Set



WARNINGTo avoid injury to the user, keep fingers away from the peristaltic pump and pinch valve.

Note

Contamination guard must be replaced every six months or when the color changes.

Note

Since there are several brands of canisters, the canister may appear different from in the picture above.

3. Close the cartridge door.

4. Connect the contamination guard to the vacuum port of the canister.

Make sure the contamination guard is in place and check expiration date.



5. Connect the aspiration tubing to the patient port of the canister.

Note

Make sure the remaining ports on the canister are covered.

6. From the rear of the console, lift the IV pole straight up.



7. Rotate the IV pole hook 180 degrees to the left until you feel it lock into place.

8. Hang the irrigation fluid bag on the IV pole hook. Use saline or Lactated Ringer’s solution.



9. Remove cover from the IV spike end of the irrigation tubing.



6.1 OverviewCleaning and sterilization of the CUSA® Clarity system in accordance with the instructions, safety warnings, safety cautions, and user notes listed in the Operator’s Manual is essential to the longevity and proper operations of the system. This chapter provides the trained technician or engineer the capability to properly clean and sterilize the CUSA Clarity system components and accessories.

6.2 Detaching System Components

After a surgical procedure, keep or discard components and accessories based on the following table.

Chapter 6 - Cleaning and Sterilizing the System

Keep Discard

Handpiece Nosecone

Contamination Guard Flue

EUTs (with less than 5 uses) Tip Stylet

Torque Base Torque Wrench

Foot switch CUSA Quick Connect™ Cartridge and Tubing Set

Power Cord Aspiration Canister

Sterilization Tray Irrigation Supply

Specimen Trap (if used)

Single Use Tip

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

Table 6-1 Detachable System Components

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 fitting on the handpiece flue.

5. Slide the flue off the nosecone base along the tip.



CAUTION


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 two 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 Table 6-1 in compliance with hospital policy for contaminated waste.

Detaching the Console1. 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).

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

3. Open cartridge door, if necessary press the pinch valve button, 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.



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.

WARNINGElectric Shock Hazard - Always unplug the CUSA Clarity System before cleaning or sterilizing it.

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.

WARNINGBio-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.

7. Discard the used/contaminated items in compliance with hospital policy for contaminated waste.

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

6.3 Cleaning and Sterilizing the SystemClean the CUSA® Clarity System console, cart, cables, and other associated components before performing any other service procedures Sterilize all parts that have direct or indirect contact with a patient before performing any service procedures.



6.3.1 Cleaning Procedures

Cleaning the Touchscreen:Clean the touchscreen with a lint-free wipe and a cleaner. The cleaner may be window/glass cleaner, eyeglass cleaner, or an ammonia-based disinfectant. Always apply the cleaner to the lint-free wipe, never directly on the touchscreen, to avoid scratching the surface.

NoteDo not wipe the touch screen with a sponge because it may scratch the surface.

NoteNever apply cleaner directly to the touch screen.

NoteMake 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.

WARNINGDo not allow fluids to enter the console.

Cleaning the Console and Cart • Unplug the power cord from the wall receptacle and the console.

• Clean the surface with a lint-free wipe soaked with one of the following:

o 70% IPA

o Super Sani-Cloth®

o Sani-Cloth® Bleach

• Make sure the surfaces remain visibly wet for a minimum of two (2) minutes, and then air dry.

• Clean the wheels at the base of the system cart to ensure that the anti-static four wheels function correctly.

Cleaning the Footswitch

• Disconnect the footswitch from the console.

• Wipe it clean.



NoteMake sure to keep the connector dry.

NoteMake sure to keep the handpiece cable connector dry.

• If the footswitch is contaminated with blood or fluid:

o Immerse the footswitch in warm water containing detergent or disinfectant.

o Rinse the footswitch with clean water.

• Allow the footswitch to drain after rinsing.

Cleaning the Handpiece, EUT, and Torque Base:The handpiece, tips, and torque base may be cleaned by either manually cleaning or autowash cycle process prior to sterilization.

Item Initially Sterile Reusable/Requires Sterilization by the User

Validated Number of Sterilizations Cycles

Sterilization Method

Handpiece No Yes 200 Steam

Torque Base No Yes 200 Steam

Torque Wrench Yes No Single Use Not Applicable

CUSA Quick Connect Cartridge 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 5 (EUT tip only) Steam

All other items: No (not reusable; but require sterilization prior to use)

Flue, stylet and nosecone - one time prior to use

6.3.2 Sterilizing the SystemSterilize the CUSA® Clarity system components and accessories with steam. Some of the CUSA Clarity system accessories are sterile, single-use items. Other accessories are reusable. Table 6-2 describes the sterilization requirements for the handpiece and accessories.

• Manually Cleaning the Handpiece, Tips and Torque Base

o 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.

o Clean the exterior of the handpiece and tip with a lint free cloth soaked with warm water and a non-alkaline detergent.

o Manually clean the junction with a soft cloth where the tip attaches.

o Rinse the entire handpiece, tip thoroughly with water, and dry with a soft cloth.

• Autowash Cycle:

o Before autowashing, thoroughly clean the internal channels of the handpiece and other components with the cleaning brush Continue to pass the brush through the tip and handpiece until it comes out clean.

o 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.

Table 6-2 Sterilization Requirements

WARNINGSingle-use devices are for single patient use only. Do not reprocess or re-use.



Package the handpiece and components for sterilization. Integra provides a sterilization tray for steam sterilization of the CUSA® Clarity handpiece. This tray protects the handpiece during sterilization and during transfer to the sterile field.

Packaging the Handpiece and Components for Sterilization The handpiece and components must be cleaned prior to sterilization, see “Cleaning the Handpiece, EUT, and Torque Base” in Section 6.3.1.

Sterilization Tray Layout

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)

➀➁

➂ ➃

➄➅

➆

Most Common Sterilization Tray Configuration



EUT Sterilization Tray Configuration

1. Place the handpiece in the appropriate slot ➀ and align it with the outline on the bottom of the tray.

2. Wrap the handpiece cable around the posts ➁.

3. Place the handpiece connector in the appropriate slot ➂ and align it with the outline on the bottom of the tray.

4. Optional. Place the nosecone in the appropriate slot ➃ and align it with the outline on the bottom of the tray.

5. Optional. Place the flue ➄ anywhere on the bottom of the tray.

6. Place the torque base in the appropriate slot ➅ and align it with the outline on the bottom of the tray.

7. Optional. Place the Extended Use Tips (up to 3) in the appropriate slots➆ and align them with the outline on the bottom of the tray.

8. Put on the lid ➇ on the sterilizer tray.

9. Close and latch the lid.

Sterilization Parameters Sterilize the CUSA Clarity handpiece and components with steam.

Sterilization Tray Packaging Packaged in a sterilized tray, the handpiece and components are:

• 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 Temp Type Time Dry Cycle

Wrapped

132°C/269.6°F

134°C/273.2°F

134°C/273.2°F

Prevac 4 min 30 min

Prevac 3 min 30 min

Prevac 18 min 30 min

Flash 132°C/269.6°F Prevac 4 min None

Table 6-3 Sterilization Cycles



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 outlined in these instructions. If you deviate from this recommended method of sterilizing, it is your Health Care Facility’s responsibility to validate the deviation.

CAUTION

Do not use sterilization methods involving temperatures in excess of 134°C (273.2°F) as this may damage the handpiece.



7.1 OverviewAnnual Preventive Maintenance and Testing is required to inspect for any possible wear that will degrade your CUSA Clarity System’s essential performance or operation. Being proactive in your CUSA® Clarity Preventive Maintenance program ensures your equipment will run at optimal capability for longer, allowing you to get the most from your tissue ablation device, protecting your patients, users and your financial investment.

This Preventive Maintenance is to ensure that Essential Performance of the CUSA Clarity system remains valid for the stated service life of the product and to guarantee safe operation for the patient and the user. Only a trained Integra Service technician or authorized distribution partner may perform preventive maintenance on the system.

7.2 Routine Care and MaintenanceThis section describes routine maintenance tasks for the system. Biomedical Engineering at the facility should perform these tasks. It also describes handling and storage information for the system, and information on returning equipment to Integra for service. The following table lists routine maintenance tasks, when you perform each task, and the equipment on which you perform them.

Chapter 7 - Maintenance and Functional Testing

Frequency Equipment Task

Daily or when used Console Clean and wipe dry

Daily or when used Footswitch Clean the footswitch

Every 6 months, or when filter changes color Contamination Guard Replace the contamination guard. Write the installation date the guard

After 50 hours of use, or 200 surgical procedures, whichever comes first

Handpiece Return handpiece to Integra Service and replace it with a new handpiece

Table 7-1

7.3 Handpiece Maintenance

Return and Replace the Handpiece Operate the handpiece for 50 hours of ultrasonic usage (i.e. with foot pedal depressed) and 200 procedures. To ensure optimal performance, replace the handpiece once it reaches 50 hours or 200 procedures, whichever comes first. The tracking of ultrasonic usage hours and the recommendation to replace the handpiece are to support patients and users by following the recommendations outlined in the FDA Guidance Document issued March 17, 2015, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” and by complying with applicable international standards.

To view the hours of use, with the handpiece connected, go to the Settings screen.

Integra recommends that you retain a spare, sterile handpiece for every surgical procedure.



Handling and Transportation of the SystemIf you need to move/relocate the CUSA Clarity Ultrasonic Surgical Aspirator System within the environment of the Healthcare Facility,

note the guidelines below:

Before moving the console:

• Power off the system.

• Unplug the power cord from the wall receptacle and secure it.

• Disconnect the handpiece.

• Disconnect and remove the irrigation fluid bag.

• Lower the IV pole.

• Secure any loose objects. Make sure there are no loose objects placed on the top of the console.

• Secure the footswitch and cord.

When moving the console (if attached to a cart):

• Push the cart using the handle.

• Do not run while pushing the console and cart.

• Use an elevator to move the console between floors of a building. Never use a stairwell.

• Do not attempt to lift the console while attached to the cart.

Storage of the System and Accessories

Console

• Make sure the system is clean. Store the system in a low traffic area that is free of dirt, blood, water, and other contaminants.

• Contamination guard may be stored with console if it is not expired.

• Store the system at an ambient temperature between -20°C (-4°F) and 60°C (154°F).

Console with Cart

• Wrap footswitch cord around cart and store footswitch in cart basket.

• Wrap power cord around cart.

• Make sure the system is clean. Store the system in a low traffic area that is free of dirt, blood, water, and other contaminants.

• Contamination guard may be stored with console if it is not expired.


Handpiece

• Store the handpiece and torque base in the sterilizer case according to your facility’s policy.




Footswitch You do not need to disconnect the footswitch from the console except for maintenance or service. When you are not using CUSA Clarity System, secure the footswitch cord.

7.4 Disposal of the EquipmentThe CUSA Clarity Ultrasonic Surgical Aspirator System console, handpiece, and footswitch are considered electrical equipment and must be disposed of in accordance with regional regulation hospital protocols.

7.5 Return Equipment for ServiceBefore you return CUSA Clarity equipment, call your Integra representative for help. If the representative tells you to send the equipment to Integra, first obtain a Return Authorization Number, then clean the equipment, and ship it to Integra for service.

Obtaining a Return Authorization Number

Call the Integra Service Center for your area (refer to Integra Service Centers in this section) to obtain a Return Authorization Number. Have the following information ready when you call:

• Hospital/clinic name/customer number

• Telephone number

• Department/address, city, state, and zip or postal code

• Model number

• Serial number

• Description of the problem

• Type of repair to be done

Attach a tag with this same information to the equipment when you ship it for service.

Returning the ConsoleClean the console and touchscreen before you package it for shipping.

Note

To avoid product damage, use proper packaging materials and packing procedures when preparing the console for shipment. Failure to return product in this manner may void your warranty.

For instructions on packing the console properly, contact your Integra representative.

Returning the Handpiece

Clean and sterilize the handpiece before you package it for shipping.

Package the handpiece to protect the handpiece and handpiece cable connector from damage. Package each handpiece in a separate packaging container.



Frequency Task Procedure

Upon receipt of System Cleaning Section 6.3 Cleaning and Sterilizing

Upon receipt, following cleaning Visual Inspection Section 7.7 Visual Inspection

Upon receipt, following cleaning Perform functional tests upon receipt of the console from the distributor – troubleshoot as required.

Chapter 7: Functional Testing

Section 8.2: Exporting Logfiles

Every six months, when the color changes, or when the surgeon notices a lack of suction.

Replace the contamination guard. Section 5.6 Connecting the Tubing Set

Annually Preventive Maintenance Contact service for assistance

Annually Replace PC lithium battery. Contact service for assistance

Annually Replace Suction motor pump controller (S30904193).

Contact service for assistance

Annually Replace Contact, Grounding Finger (72905223)

Contact service for assistance

Every 4 years Replace 8GB mSATA card (72904462). Contact service for assistance

Table 7-2 Periodic Maintenance Schedule

Ordering Replacement Parts

Order the following replacement parts from an Integra Service Center:

• IV Pole

• Power Cord

• Footswitch

• Contamination Guard

When ordering replacement parts for equipment, include the following information:

• Model number (located on the CUSA Clarity console rear panel)

• Serial number (located on the CUSA Clarity console rear panel)

7.6 Periodic Maintenance ScheduleThe CUSA Clarity system is designed to meet the requirements specified in IEC 62353, Edition 2.0 2014-9. Record all periodic maintenance activities on the data sheet supplied with this manual.



7.7 Visual InspectionThe CUSA Clarity console, handpiece, and all associated components and accessories should be visually inspected for various forms of disrepair prior to disassembling, cleaning, sterilizing, or proceeding with preventive maintenance. Replace all damaged components and accessories.

When conducting a visual inspection, the technician shall:

• Confirm all labels are in good condition, legible, and firmly attached (no curled or loose edges).

• Inspect the console body for scratches on front and rear component as well as the metal cover.

• Check canister holder for damage and deformation.

• Inspect for scratches or damage to footswitch.

• Check condition of the AC power cord attached to the console.

• Inspect for cracks or damage to touch screen display.

• Check handpiece cable connector and contamination guard connector for cracks or damage.

• Check suction pinch valve for damage

• Check irrigation door for damage and check it is opening and closing smoothly.

• Check system fan vent is free from obstruction.

• Inspect the IV Pole at the rear side for damage and check its functionality.

• Check to ensure fuses are in-place.

• Check connectors for damage and correct orientation.



Table 7-3 Functional Test Equipment and Tools

• Inspect cart for damage

• Inspect cart wheels for proper rotation and direction

• Inspect the connection attaching the console to the cart.

• Check that all four rubber feet on the console are in place, aligned with the indentations on the cart, and are not damaged.

7.8 Electrical Safety TestsThe electrical safety tests are required to meet the requirements specified in IEC 62353, Edition 2.0 2014-9. Refer to Integra Global Service and Repair Procedure IT0738 for instructions to complete the tests. This Integra Global Service and Repair Procedure IT0738 and test datasheet are located in Appendix A.

To reduce the risk to the service technician, perform and pass an electrical test before engaging in any service or maintenance activity on a CUSA Clarity System.

7.8.1 Required Equipment and Tools

Equipment/Tools Description

Safety Analyzer Rigel 288 or Rigel 62353 or Fluke ESA620 or equivalent

Digital Multi-meter Keysight 34461A, Fluke 187 or equivalent

CUSA® Clarity console mains cable Fitted with the console

CUSA® Clarity 36 kHz Handpiece Integra Ref. C7036

CUSA® Clarity 36 kHz Curved Ext MicroTip (Single Pack) Integra Ref. C7414

CUSA Clarity Quick Connect™ Tubing Set (Single pack) Integra Ref. C7300EA

Waste canister Bemis BEH484410 or equivalent

Jar of water Any 1-liter jar

Contamination guard Integra Ref. C7005

CUSA® Clarity footswitch Integra Ref. C7002



Voltage Rated Value

actual mains voltage

Frequency Rated Value

actual mains frequencyEquipment Leakage Current = x actual Leakage Current x

Example

When the test is performed at 230V/50Hz, and the measured Leakage Current is 50 µA, the Equipment Leakage Current will be:

60 Hz

50 HZEquipment Leakage Current = 62,6 µA = x 50 µA x

240 V

230 V

7.8.2 Test Conditions

Perform the electrical safety test at the ambient temperature, humidity, and atmospheric pressure at the testing site.

7.8.3 Normalization InstructionsAs this test is performed with mains voltage present at the site of testing, measurements have to be normalized before comparing with acceptance criteria. Normalization is done according to the following formula:

Use a Digital Multi-meter to measure actual voltage.

7.8.4 Test Procedures

Grounding/Earthing SystemObtain the grounding/earthing system information for the electricity supply at the test location (e.g., TN- or IT-System). The type of grounding/earthing system determines the applicable method used to measure leakage current.

• IT-System is commonly found in the Operating Room environment

• TN-System is normally in the biomedical workshop environment

Measurement of Protective Earth Resistance This test evaluates the integrity the protective earth conductor of the power supply cord and earthing connections of metallic accessible part of the console and footswitch. During the measurement, the main cord shall be flexed along its length. If during the flexing, changes in resistance are observed, it shall be assumed that the protective earth conductor is damaged or the connections are no longer adequate.

1. Connect the Safety Analyzer directly to the power source for TN- or IT-Systems.

2. Connect the console to the main socket of Safety Analyzer, and connect the Test Lead to the relevant socket of the Safety Analyzer as shown in Figure 7-1.

Figure 7-1



Test Description Unit Acceptance Criteria

Equipment Leakage Current µA ≤ 500 µA

Table 7-5 Equipment Leakage Current Acceptance Criteria (Direct Method)


Equipotential Earth Ground pin Ω ≤ 300 mΩ

Cartridge Door Ω ≤ 300 mΩ

Handpiece Socket Connector Ω ≤ 300 mΩ

Figure 7-2

3. Measure the Protective Earth Resistance for each connection listed below:

Table 7-4 Protective Earth Resistance Acceptance Criteria

4. Record values in the Electricial Safety Test Datasheet (IT0738A in Appendix A).

Measurements of Equipment Leakage Current

(a) TN-System (Direct Method)1. Connect the Safety Analyzer directly to the main power source for a TN-System.

2. Connect the console to the main power socket of the Safety Analyzer.

3. Attached the crocodile clip from the Safety Analyzer lead (Applied Part module port 1) to the proximal end of the tip (without the flue) as shown in the Figure 7-2.

4. Attached the test lead from the safety Analyzer lead (Applied Part module port 2) to the Equipotential Earth Ground pin of the console as shown in the Figure 7-2.

5. Select Equipment Leakage Current measurement on the safety Analyzer.

6. Turn on the DUT and wait for the GUI to load.

7. Connect the handpiece, aspiration, irrigation tubing kit, waste canister, and other accessories to the console and cart.

8. Prime the irrigation tubing and perform a handpiece test.

9. On the DUT main menu, set up the system as follows:

• AMPLITUDE to 100%

• ASPIRATION to 100%

• IRRIGATION to 2ml/min

• TISSUE SELECT to OFF

10. Press down the footswitch pedal to achieve maximum stroke.

11. Obtain the Equipment Leakage Current measurement, and normalize the value according to Section 7.8.3 Normalization Instructions.

12. Record values in the Electrical Safety Test Datasheet (IT0738A in Appendix A).



WARNING


NOTE

The Direct Method delivers erroneous values when supplied by an IT power system.

(b) IT-System (Alternative Method)1. Connect the Safety Analyzer to the power source for an IT-System.


3. Attached the crocodile clip from the Safety Analyzer lead (Applied Part module port 1) to the proximal end of the tip (without the flue) as shown in the Figure 7-3.

4. Attached the test lead from the Safety Analyzer lead (Applied Part module port 2) to the Equipotential Earth Ground pin of the console as shown in the Figure 7-3.

Figure 7-3

5. Install the handpiece.

6. Select Equipment Leakage Current measurement on the safety Analyzer.

7. The console stays off.

8. Obtain the Equipment Leakage Current measurement, and normalize the value according to Section 7.8.3 Normalization Instructions.



Equipment Leakage Current µA ≤ 1000 µA

Table 7-6 Equipment Leakage Current Acceptance Criteria (Alternative Method)

WARNING





Applied Part Leakage Current µA ≤ 50 µA

Table 7-7 Equipment Leakage Current Acceptance Criteria (Direct Method AC)

WARNING


NOTE

The Direct Method delivers erroneous values when supplied by an IT power system.

Measurements of Applied Part Leakage Current

(a) TN-System (Direct Method AC)1. The Safety Analyzer is connected directly to the mains on TN-System


Figure 7-4

3. Select Applied Part Leakage Current measurement on the safety Analyzer.

4. Turn on the DUT and wait for the GUI to load

5. Connect the handpiece, aspiration, irrigation tubing kit, waste canister, and other accessories to the console and cart.

6. Prime the irrigation tubing and perform a handpiece test.

7. On the DUT main menu, set up the system as follows:

• AMPLITUDE to 100%

• ASPIRATION to 100%

• IRRIGATION to 2ml/min

• TISSUE SELECT to OFF

8. Attached the crocodile clip from the Safety Analyzer lead (Applied Part module port 1) to the proximal end of the tip (without the flue). Immerse the full tip into a jar feed with 1 liter of water.

9. Press the footswitch Vibrate pedal fully down, to achieve maximum stroke.

10. Obtain the Applied Part Leakage Current measurement, and normalize the value according to Section 7.8.3 Normalization Instructions.




(b) IT-System (Alternative Method AC)1. Connect the Safety Analyzer to the main power source for an IT-System.

2. Connect the console to the main socket of the Safety Analyzer.

3. Attached the crocodile clip from the Safety Analyzer lead (Applied Part module port 1) to the proximal end of the tip (without the flue). As shown in Figure 7-5.

Figure 7-5


Applied Part Leakage Current µA ≤ 50 µA

Table 7-8 Equipment Leakage Current Acceptance Criteria (Alternative Method AC)

4. Connect a handpiece.

5. Select Applied Part Leakage Current measurement on the safety Analyzer.

6. The console stays off.

7. Obtain the Applied Part Leakage Current measurement, and normalize the value according to Section 7.8.3 Normalization Instructions.

8. Record values in the Electrical Safety Test Datasheet (IT0738A in Appendix A)

7.8.5 Electrical Safety Test Record AssessmentTake previously measured values into consideration when assessing the results of this electrical safety test. A significant increase from previous values may indicate a future problem. The equipment is safe if the value is below the limit despite a significant increase. An increased value is not a leading indicator of pending failure; however, it is advisable to conduct the next test at a six-month interval rather than waiting one year.

If the system fails the electrical safety test, mark the console as failed, document the results, and arrange to repair the device by an authorized service technician.

7.9 Functional Tests

7.9.1 Test Conditions Refer to Integra Global Service and Repair Procedure IT0739 for instructions to complete the tests. This Integra Global Service and Repair Procedure IT0739 and Test Datasheet are located in Appendix A



Equipment/Tools Description

Digital Manometer Fisher 3461 or Fluke PV350 or Equivalent

CUSA Clarity 36 kHz Handpiece Integra Ref. C7036

CUSA Clarity 36 kHz tip Integra Ref. C7414

Handheld digital tachometer Testo 470 or DT2236 or equivalent

Reflective tape for the digital tachometer RS Components P/N: 845-9731

CUSA Clarity footswitch Integra Ref. C7002

CUSA Clarity Quick Connect Tubing Set (Single pack) Integra Ref. C7300EA

T Connector RS Component P/N: 795-405



Table 7-9 Electrical Safety Test Record Assessment Equipment and Tools

7.9.2 Required Equipment and Tools

7.9.3 Test Conditions Perform the electrical safety test at the ambient temperature, humidity, and atmospheric pressure at the testing site.

7.9.4 Test Procedures

Test Setup• Turn on the console

• Connect the footswitch and handpiece

• Connect a contamination guard and the canister

• Open the cartridge door and stick the reflective tape on the border of the pump head

• Place the cartridge on the pump head, close the door and connect the aspiration tubing set to the canister

• Attach the T connector in line between the distal end of the aspiration tubing set and the handpiece suction port

• Connect the third port of the T connector to the Digital Manometer.

• From the Setup Task menu press the Start Prime button – wait until the prime is completed

Ultrasound Test• From the Setup Task menu press Start Test button

• When the test is completed, press Details button

• Record that the Tip Frequency Optimization passed the test in IT0739A CUSA Clarity GS&R End User Functional Test Datasheet (Appendix A).



Irrigation Test• Press Main Screen button

• Position Aspiration Mode on Constant position

• Position the Digital Tachometer in front of the cartridge door

• Select Irrigation at 2 ml/min

• Measure the speed of the pump head – record the value

o Expected value is from 2 to 8 RPM

• Press Fast Flush pedal

• Measure the speed of the pump head – record the value

o Expected value is from 34 to 47 RPM

• Record irrigation values in IT0739A CUSA Clarity GS&R End User Functional Test Datasheet

Aspiration Test• From Main Screen, select Aspiration Mode on Constant position

• Set aspiration at 100%

• Measure the Aspiration – record the value

o Expected value is from 304 to 436 mmHg.

• Record aspiration values in IT0739A CUSA Clarity GS&R End User Functional Test Datasheet

7.10 Returning the Clarity System to Use

When functional testing is complete, accomplish the following actions to return the CUSA Clarity system to service:

• Clean the system

• Remove the maintenance label and replace with a new maintenance label

o Include the date of service on the new label.

• Include a copy of the Electrical Safety Test Datasheet IT0738A with the CUSA Clarity End User Functional Test Datasheet IT0739A.



Intentionally Blank



8.1 Overview

This chapter provides information on troubleshooting the CUSA® Clarity console or handpiece to locate faulty subassemblies. The outline for general troubleshooting processes is Figure 8-1. In case of abnormal functions reported by troubleshooting assessment, contact authorized repair partner.

8.2 Exporting Logfiles

The CUSA Clarity maintains logfiles of events, including error codes and handpiece data from all handpiece connected to the console. Logfiles are stored as text files. They open using any text editor program (e.g., Notepad). A technician may import Logfiles into a spreadsheet using tab-separated variable format. To export logfiles stored in the CUSA Clarity console:

1. Insert a USB stick into the CUSA Clarity USB port at the rear side of the console. Format the USB stick as FAT (FAT16, FAT32 or exFAT) or NTSF. The system does not support other file formats.

2. From the Main Screen, press the Setting button

3. From the Setting Screen, press the System Information button

4. From the System Information Screen, press the Extract Log button

5. When files are copied, Resume button appears; press button and remove the USB stick

6. Insert the detachable memory device into a PC and browse the CUSA logfiles folder. Log files are located in a sub- folder named with the serial number of the console. This folder contains:

• Logfiles containing all events dated since the manufacturing of the console.

• MaintenanceTrendData.csv containing monitored values dated since the manufacturing of the console.

• Handpieces folder containing all handpiece logfiles from all handpiece connected to the console previously. The system names the handpiece logfiles using the format Handpieces serial number-Handpieces part number.

• Zip the extracted folder and send it to [email protected].

8.3 Alarm Descriptions

Chapter 8 - Troubleshooting the System

Condition Cause Recommendation

Low Aspiration The console has measured the aspiration level to be too low to be functioning properly

• Check tubing connections and routing• Replace tubing set if problem persists

Handpiece Failure A fault has occurred reading or writing to the handpiece memory chip

• Disconnect and reconnect handpiece• Replace handpiece if problem persists

Footswitch failure A footswitch wiring or connection fault has been detected • Disconnect and reconnect footswitch• Replace footswitch if problem persists

Console Overheating The console is excessively warm; it will automatically shutdown Contact Integra Service

Console Failure (Recoverable)

A fault has occurred when restoring the previously used settings or service information; default values may be used

System is unusable; notify Integra Service

Console Failure A fault condition has been detected within the console Restart console, contact Integra Service if problem persists

No fragmentation No fragmentation may occur while using CUSA Clarity in conjunction with a monopolar eletrosurgery system

• Go into Stand-by• Press Start Prime• Press Stop Prime• Press Start Test• Press Main Screen

Table 8-1



Condition Recommendation

Fan Failure Contact Integra Service

Low battery System is useable, but notify Integra Service

No Fragmentation No fragmentation may occur while using CUSA Clarity in conjunction with a monopolar eletrosurgery system. If you experience no fragmentation, take the followings steps:• Go into Stand-by• Press Start Prime• Press Stop Prime• Press Start Test• Press Main Screen

Table 8-2

8.4 Technical Messages



8.5 General Troubleshooting

Troubleshooting

Is a critical part damaged?

Setup the console with main power cord, known working handpiece, tubing

set and footswitch.Turn on the console.

No

Call Integra for assistance.

Yes

Does the unit power up? (Fan turning)

Does the GUI provide a failure

code?

Yes

Check Mains fuses

No

Does powerbutton illuminate

when pressed?

Yes

No

Fuses damaged?

No


Yes

Low Aspiration at the hanpiece tip?

No

Yes

Yes

No

Explore Error codes matrix root causes &

solutions

Explore Low Aspiration at the hanpiece

tip root causes & solutions

Explore Excessive misting at the handpiece tip

causes & solutions

Yes

No or low Ultrasonics?

Explore Ultasonics root

causes & solutions

No

Yes

End

No

Yes

NoDoes the touch panel respond?

Yes

NoDoes the screen light up

Replace Mains fuses

No irrigation flow from the

handpieceFlue?

No

Excessive misting at the handpiece tip?

Explore No irrigation flow from the handpiece

Flue root causes & solutions

Yes



Does the GUIreport a message in

the Status Bar?

Explore Status Bar root causes

& solutions

Yes

No

Figure 8-1



8.6 Amplitude Troubleshooting


Amplitude Indicator bar not equal to selected amplitude, or pulsing erratically

• On Tissue Select 3-High, or 4-Maximum, Amplitude Indicator is always lower than selected amplitude

• During aggressive tissue fragmentation, small amplitude drops may briefly occur

• If Amplitude Indicator is persistently low or erratic, stop vibration – allow handpiece to cool

• Return to Setup Screen and repeat handpiece test

Ineffective fragmentation (due to frequency drift – temperature dependence

1. Go into standby mode

2. Run handpiece test to update the frequency optimization

Low or no aspiration 1. Check aspiration at the end of the tip to make sure the aspiration is being delivered to the distal end of the tip

2. Check tubing and connections for leaks

3. Verify connections to canister

4. Utilize the stylet to clear the clog

Table 8-3

WARNING

To avoid injury or damage to equipment, place system in standby mode prior to changing tip or clearing a clog.

NOTE

To avoid tip blockage during surgery, flush the saline solution in between uses. This removes debris before it can dry and block the tip while it is not in use.

8.7 Aspiration Troubleshooting


Excessive aspiration in On Demand aspiration mode

• Remove and re-install the cartridge to make sure the tubing is in the pinch valve

• Press the pinch valve button to open and close the valve 3 to 5 times to ensure the valve closes completely

• Replace cartridge set

• Contact Integra Service

Difficulty with removing cartridge • If the system is powered on, lift the cartridge door and remove cartridge

• If the system is powered down, press the pinch valve to remove the cartridge

Table 8-4



Aspiration Troubleshooting Flowchart

Low Aspiration at the handpiece tip

Low Aspiration setting on the

screen?

No

End

Yes Increase the Aspiration setting.

« On demand » function set on the

screen?Select « Constant »

Yes

No

Blocked Tip / Aspiration line at the

Handpiece?

- Immerse the handpiece tip in sterile irrigation fluid briefly. This may clear the blockage.- Use the tip cleaner to dislodge the blockage in the tip. Continue to push the tip cleaner into the tip until the cleaner becomes visible in the tubing.- As necessary, disconnect, clean, and reconnect the Aspiration tubing connector at the handpiece.

Yes

No

A blockage in the Aspiration line between the handpiece and the

suction canister?

Straighten the tubing to remove a kink, or remove anything that might pinch the tube along its entire length for a blockage.

Yes

Suction canister full? Replace the suction canister.

Suction connections at the suction canister not

seated properly?

- Remove any unused suction canister “elbow” connectors.- Reseat all connections- Refer to the canister manufacturer’s instructions for connecting the canister.

Yes

Open port(s) on the suction canister?

No

Close any open ports on the suction canister.

Yes

No

Inside of the contamination guard

wet, blocked or both?

- Disconnect the contamination guard fitting from the suction Canister tubing. If you do not feel suction at the end of the contamination guard fitting, the guard is blocked.- Replace the contamination guard.

Yes

No

Pinch valveworking incorrectly?

Check on the screen the « On Demand / Constant » indicator.- If set to « Constant » the pinch valve should be open.- If set to «On Demand » the pinch valve should be open only when you activate Ultrasonics.If these conditions do not exist, call Integra for assistance.

Yes

No

No

Yes

No

Crack at the suction canister that causes a

leak?Replace the suction canister.

No

Yes

Figure 8-2


Insufficient irrigation • Check tubing connections and routing for leaks or blockages

• Check the handpiece is fully primed and irrigation fluid is visible at the flue

• Replace tubing set

Fast flush not working • Make sure On Demand aspiration mode is not selected

• Make sure the amplitude pedal is not pressed

Table 8-5

8.8 Irrigation Troubleshooting



Aspiration Troubleshooting Flowchart

Figure 8-3

No irrigation flow from the handpiece

No

Is the irrigation tube connected to the handpiece

tip flue?

Connect irrigation tube to handpiece tip flue

No

Was prime completedfully so that fluid filled the

irrigation tubing?

- Return to Setup Task Menu- Press the Start Prime button, allowing time forirrigation fluid to drip from the tip.

Yes

Yes

Irrigation tubing pinched or kinked?

Remove the pinch or kink from thetubing.

Yes

No

I.V. bag empty? Replace the I.V. bag.

Yes

No

No

IV clamp opened? Open the IV clampNo

End

Irrigation pump not turning?

Check on the screen the « On Demand / Constant » indicator.- If set to « Constant » the Irrigation pump should be turning.- If set to «On Demand » the Irrigation pump should be turning only when you activate Ultrasonics.If these conditions do not exist, call Integra for assistance.No

Yes

Irrigation tubing properly sited on

rollers pump

- Open irrigation pump door- Place properly irrigation tubing on the rollers- Close irrigation pump door

No

Yes



8.9 Status Bar Root Causes and Solutions

Status Bar root causes & solutions

Perform Setup Task: Connect footswitch

- Check if the footswitch connector is properly connected.- If the footswitch is already connected, replace the footswitch (part number C7002).- if the problem persists, call Integra for assistance.

Yes

Perform Setup Task: Connect handpiece

Yes

No

Perform SetupTask: Connect

Tubing cartridge

Yes

No

Close cartridge doorYes

No

No

- Check if the handpiece connector is properly connected.- If the handpiece is already connected, replace with a new handpiece C7036.- if the problem persists, call Integra for assistance.

- Check if the cartridge is properly installed and the door is closed.- if the problem persists, call Integra for assistance.

- Check if the cartridge door is properly closed.- if the problem persists, call Integra for assistance.

- Goto Setup Task Menu.- Press Start Prime button.

Perform Setup Task: Prime handpiece

Yes

- Goto Setup Task Menu.- Press Start Test button.

Perform Setup Task: Test handpiece

No

Yes

No

System is overheating. Contact

service- Call Integra for assistance.

Yes

System fan failure. Contact service - Call Integra for assistance.

Yes

No

Battery needs replacement.

Contact service

- The battery discharge is considered complete but the system is usable.- Call Integra for assistance.

No

Yes

End

No

Figure 8-4



8.10 Error Code MatrixFor all error codes, except those explained below, contact Integra Service and Repair for assistance..

Error Code Description Root Cause Solution 1 Solution 2

E1208 Vacuum Pressure Low Vacuum is lower than expected Connect a contamination guard

Fix leakage on suction tubing set

E1220 Irrigation Motor RPM Irrigation motor speed is different from the demand. Check if something is blocking the irrigation pump head

Fix blockage at the pump head

Call Service for assistance

E1226 Pinch Solenoid Position Pinch valve is not at the expected position (staying opened)

Check for blockage Call Service for assistance

E1400 Pinch Solenoid Position Pinch valve is not at the expected position (staying closed)

Check for blockage Call Service for assistance

E2201 Broken footswitch microswitch failure

Microswitch from Ultrasonic footswitch is defective

Replace footswitch Call Service for assistance

E2202 Broken footswitch potentiometer Potentiometer from Ultrasonic footswitch is defective


E2203 Broken fast flush footswitch Microswitch from fast flush footswitch is defective


E2303 Invalid handpiece EEPROM version Handpiece EEPROM corrupted Replace handpiece Call Service for assistance

E2304 Invalid CRC on handpiece EEPROM Handpiece EEPROM corrupted Replace handpiece Call Service for assistance

E2305 Handpiece EEPROM parameter out of range

Handpiece EEPROM corrupted Replace handpiece Call Service for assistance

Table 8-6



Excessive Misting at the Handpiece Tip Causes & Solutions

Figure 8-5

Flue not lined up with tip pre-aspiration

holes?

Adjust the flue position to line up with the pre-aspiration holes in the tip.

Yes

High Irrigation setting on the

screen?

No

Reduce the Irrigation setting.

Yes

Low or no suction due to

Aspiration line improperly connected to

handpiece

No

Verify that the manifold suction tube connects properly to the handpiece by disconnecting, then reconnecting, the tubing.

Yes

No

Low Aspiration setting on the

screen?

Increase the Aspiration setting.

No

Yes

Blocked Tip?

- Immerse the handpiece tip in sterileirrigation fluid briefly. This may clearthe blockage.- Verify that the manifold suction tube connects properly to the Handpiece.- Use the tip cleaner to dislodge the blockage in the tip. Continue to push the tip cleaner into the tip until the cleaner becomes visible in the tubing.

Yes

No

Blockage in the Aspiration line at the

Handpiece?

- Immerse the handpiece tip in sterileirrigation fluid briefly. This may clearthe blockage.- As necessary, disconnect, clean, and reconnect the Aspiration tubing connector at the handpiece.

Yes

A pinch or kink in the Aspiration line?

Straighten the tubing to remove a kink, or remove anything that might pinch the tube.

Yes

No

A blockage in the Aspiration line between the handpiece and the

suction canister?

- Examine the Aspiration line along its entire length for a blockage.- Squeeze the blocked area to loosen it.- Immerse the handpiece tip in sterileirrigation fluid briefly. This may clearthe blockage.

Yes

No

Suction canister full? Replace the suction canister.

No

Yes

End

Suction connections at the suction canister not

seated properly?

- Remove any unused suction canister “elbow” connectors.- Reseat all connections.

Yes

Open port(s) on the suction canister?

No

Close any open ports on the suction canister.

Yes

Suction canister improperly

Connected?

No

Refer to the canister manufacturer’s instructions for connecting the canister.

Yes

Inside of the contamination guard

wet, blocked or both?

No

- Disconnect the contamination guard fitting from the suction Canister tubing. If you do not feel suction at the end of the contamination guard fitting, the guard is blocked.- Replace the contamination guard.

Yes

Problem at the CUSA Clarity console

suction port

No

Remove the contamination guard and put a finger in the suction system port. If you feel no suction, call Integra for assistance.

Yes

Suction pinch valve working improperly?

No

Check on the screen the « On Demand / Constant » indicator.- If set to « Constant » the pinch valve should be open.- If set to «On Demand » the pinch valve should be open only when you activate Ultrasonics.If these conditions do not exist, call Integra for assistance.

Yes

No

No

Excessive misting at the handpiece tip



Ultrasonic Root Causes & Solutions

Figure 8-6

Excessive tip/tissue pressure (stalling tip)?

- Verify that console settings are at desired levels- Remove the tip from contact with tissue, then reactivate vibration.Note: When first activating vibration, make sure that there is no tip/tissue pressure.

Yes

No

Blocked Tip?

- Immerse the handpiece tip in sterileirrigation fluid briefly. This may clearthe blockage.- Verify that the manifold suction tube connects properly to the Handpiece.- Use the tip cleaner to dislodge the blockage in the tip. Continue to push the tip cleaner into the tip until the cleaner becomes visible in the tubing.

Yes

No

Incorrect flue installed? Install the correct flue.

Yes

Tip loose due to improper assembly?

- Press the Setup / Standby button to place the system in Standby mode.- Remove the handpiece from thesterile field.- Use the sterile torque base and a disposable sterile wrench to tighten the tip. (Refer to Cusa Clarity IFU)- Press Start Test button

Yes

No

Damaged handpiece?

- Press the Setup / Standby button to place the system in Standby mode.- Press Start Test buttonIf the test fail press Detail button and follow instructions. (Refer to Cusa Clarity Operator Manual)- Replace handpiece if problem persists

Yes

No

No

End

Little or no vibration or fragmentation

Amplitude level fluctuating on the

screen?Call Integra for assistance

No

Yes



9.1 Overview

This chapter describes each field replacement part of the system and provides disassembly/ reassembly instructions for their replacement.

This manual describes the proper extent of component disassembly.

Chapter 9 - Disassembly and Reassembly of Sub-Assemblies

9.2 Required Tools and Equipment

• Torque screwdrivers

o Setting: - 1.62 N-m (14.3 in-lbs) for M4 and smaller

- 2.94 N-m (26.0 in-lbs) for M5 and M6

- 40 N-m (29.5 in-lbs) for M12

• Metric Socket Set up

• M22 flat spanner wrench

• M24 flat spanner wrench

• Metric Allen bits Set

WARNING

Turn off the power before opening the console - disconnect the power cord.

CAUTION

Only authorized engineer by Integra can open the console

NOTE

Discard lock washers removed during disassembly and replace with new lock washers when reassembling.

NOTE

When reassembling a lock washer and a flat washer, always place the lock washer between the screw head and the flat washer.



Figure 9-1

Installation

Position the IV pole as shown in Figure 9 2; refit the 2 x M5 x 35 Ref. 72904930 screws using 3 mm Allen bit.

Ensure the IV pole is sliding up and down.

Figure 9-2

9.3 IV Pole Replacement Ref. S30905284

Removal

Unscrew the 2 x M5 x 35 Ref. 72904930 screws as shown in Figure 9-1 using 3 mm Allen bit. The IV pole will come apart.

Unscrew

Screw



9.4 Disassembling CUSA® Clarity Console from CartUnder the top of the cart, remove the M8 X 60 MM SOCKET HEAD CAP SCREW Ref. S72905320 and M8 EXTERNAL TOOTH LOCK WASHER

Ref. S72905321 using HEX L-KEY, 6 MM Ref. S72905103 provided with the Cart as shown in Figure 9 3.

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


Figure 9-3

Lift the CUSA Clarity console off the Cart as shown in Figure 9 4.

Figure 9-4

Unscrew



CAUTION

The CUSA Clarity console weight is 29.5 kg (65 lbs). Make sure you can handle this weight.

CAUTION


Figure 9-5

Refit the M8 X 60 MM SOCKET HEAD CAP SCREW Ref. S72905320 and M8 EXTERNAL TOOTH LOCK WASHER Ref. S72905321 using HEX L-KEY, 6 MM Ref. S72905103 provided with the Cart as shown in Figure 9-6.

9.5 Assembling CUSA Clarity Console on CartPlace the console on the cart by aligning the four (4) feet on the bottom of the console with the four (4) indentations on the cart as shown in Figure 9 5.



Figure 9-6

9.6 Cart Base Plate Replacement Ref. S72905007

RemovalRemove CUSA Clarity Console from the Cart according to Section 9.4 Disassembling CUSA Clarity Console from Cart.

• Remove the 4 x SCREW, SOCKET HEAD CAP, M8x50 MM Ref. S72905358 and the WASHER, EXTERNAL TOOTH, M8 Ref. S72905359 as shown

in Figure 9-7.

Figure 9-7

Screw

Unscrew



Figure 9-8

Reinstall CUSA Clarity Console on the Cart according to section 9-5 Assembling CUSA Clarity Console on Cart.

NOTE

Cart Base Plate Replacement (Ref. S72905007) includes Screws and Washer.

9.7 Cart Vacuum Canister Holder Replacement Ref. S72905009

RemovalRemove the 2 x SCREW CAP, GRAY, M5/M6 Ref. S72905362, unscrew the 2 x SCREW, FLAT-HEAD SOCKET CAP, M6X12 MM Ref. S72905360

and the WASHER, EXTERNAL TOOTH, M6 Ref. S72905361 as shown in Figure 9-9.

Figure 9-9

InstallationRefit the 4 x SCREW, SOCKET HEAD CAP, M8x50 MM Ref. S72905358 and the WASHER, EXTERNAL TOOTH, M8 Ref. S72905359 as shown in Figure 9-8.

Screw

Lock Washer

Unscrew

Remove Cap Screw



InstallationAlign VACCUM CANISTER HOLDER Ref. S72905009 holes with the 2 x SPRING NUT, M6 Ref. S72905363, as shown in Figure 9-10

Figure 9-10

Refit the 2 x SCREW, FLAT-HEAD SOCKET CAP, M6X12 MM Ref. S72905360 and the WASHER, EXTERNAL TOOTH, M6 Ref. S72905361 as shown in

Figure 9-11.

Figure 9-11

Refit the 2 x SCREW CAP, GRAY, M5/M6 Ref. S72905362 on the 2 x SCREW, FLAT-HEAD SOCKET CAP, M6X12 MM Ref. S72905360 as shown in Figure 9 12.

Figure 9-12

NOTE

Cart Vacuum Canister Holder Replacement (Ref. S72905009) includes Screws and Washer.

Screw

M6 Nut

Washer



9.8 Cart Foot Switch Basket Replacement Ref. S72905053

RemovalUnscrew and remove the 3 x SCREW, BUTTON HEAD CAP, M6X10 MM Ref. S72905364, the SCREW, BUTTON HEAD CAP, M6X12 MM Ref. S72905365 and

the SERRATED WASHER Ref. S72905368 as shown in Figure 9-13.

Figure 9-13

InstallationAlign Foot Switch Basket Ref. S72905053 holes with the 6 x SPRING NUT, M6 Ref. S72905363, as shown in Figure 9-14.

Figure 9-14

Unscrew

M6 Nut



Refit the 3 x SCREW, BUTTON HEAD CAP, M6X10 MM Ref. S72905364, the SCREW, BUTTON HEAD CAP, M6X12 MM Ref. S72905365 and the WASHER,

LOCK, M6 Ref. S72905368 as shown in Figure 9 15.

Figure 9-15

9.9 Cart Cable Winding Peg Replacement Ref. S72905054

RemovalRemove the COVER, WINDING PEG, CART, PHOENIX Ref. S72905366 using a sharped blade and unscrew the SCREW, SOCKET HEAD CAP, M6X12 MM

Ref. S72905369 as shown in Figure 9-16.

Figure 9-16

NOTE

Cart Foot Switch Basket Replacement (Ref. S72905053) includes Screws and Washer.

Screw

MKX12

Lock Washer



Figure 9-17

Refit the SCREW, SOCKET HEAD CAP, M6X12 MM Ref. S72905369 as shown in Figure 9-17.

Refit the COVER, WINDING PEG, CART, PHOENIX Ref. S72905366 as shown in Figure 9-17.

NOTE

Cable Winding Peg Replacement (Ref. S72905054) includes 2 pair of Winding Peg with Screws.

9.10 Cart Caster Replacement Ref. S72905055

RemovalRemove CUSA Clarity Console from the Cart according to section 9-4 Disassembling CUSA Clarity Console from Cart.

• Lay down the cart on the floor. With 21 mm spanner, unscrew the caster Ref. S72905055 as shown in Figure 9-18. The WASHER, FLAT, M12

Ref. S72905383 comes out with the caster. Use a 22 mm spanner to maintain the adapter.

Figure 9-18

InstallationAlign the Cart Cable Winding Peg Ref. S72905054 holes with the M6 SPRING NUT Ref. S72905363, as shown in Figure 9-17.

Use a 22 mm spanner to maintain the adapter



9.11 Cart Caster Bumper Replacement Ref. S72905056

RemovalRemove CUSA Clarity Console from the Cart according to section 9-4 Disassembling CUSA Clarity Console from Cart.

• With 22 mm spanner, unscrew the CASTER SPACER, CART, CUSA CLARITY Ref. 72905437 as shown in Figure 9-19. The M12 FLAT WASHERS

Ref S72905383, the CASTER BUMPER, PHOENIX Ref. 72905436, the WASHER, CASTER BUMPER, CART, CUSA CLARITY Ref. 72905438 and

the CASTER SPACER, CART, CUSA CLARITY Ref. 72905437 come out with the Caster.

InstallationEngage the M12 FLAT WASHER Ref S72905383 on the Caster shaft. With 21 mm spanner, refit the Caster Ref. S72905055 as shown in Figure 9-18.

Figure 9-19

InstallationEngage the WASHER, CASTER BUMPER, CART, CUSA CLARITY Ref. 72905438, the CASTER BUMPER, PHOENIX Ref. 72905436 and the M12 FLAT WASH-

ER Ref S72905383 on the CASTER SPACER, CART, CUSA CLARITY Ref. 72905437 shaft and refit the assembly on the chassis as shown in Figure 9-19.

9.12 Cart Weight Cover Replacement Ref. S72905051

RemovalRemove CUSA Clarity Console from the Cart according to section 9.4 Disassembling CUSA Clarity Console from Cart.

• Lay down the cart on the floor.

M12 Washer M12 Washer

Caster Bumper Spacer

Bumper Washer



• Unscrew and remove the 4 x SCREW, SHEET METAL, 6.3 X 16 MM Ref. S72905371 and the 2 x WASHER, M6 Ref. S72905393 as shown in

the Figure 9-20.

Figure 9-20

• Take out the Cart Weight Cover Ref. S72905051 as shown in Figure 9-21.

Figure 9-21

InstallationRefit the Cart Weigh Cover Ref. S72905051 as shown in Figure 9-22.

Unscrew



Figure 9-22

Refit the 4 x SCREW, SHEET METAL, 6.3X16 MM Ref. S72905371 and the 2 x WASHER, M6 Ref. S72905393 as shown in the Figure 9-23. Place MAX LOAD

LABEL Ref. S72905370 on the Cart Weigh Cover as shown in Figure 9-22.

Figure 9-23

Screw



Intentionally Blank



Chapter 10 - Technical Specifications

10.1 Console

10.2 Dimensions

CUSA® Clarity Console without CartHeight 49.3 cm (19.5 in)

Width 34.9 cm (13.75 in)

Depth 45.7 cm (18 in)

Weight 29.5 kg (65 lbs)

Cable Length 5 m (196.85 in)

CUSA Clarity Console with CartHeight 1.33 m (52.5 in)

Width 57.2 cm (22.5 in)

Depth 64.8 cm (25.5 in)

Weight 81.5 kg (179.6 lb)

Cable Length 5 m (196.85 in)

FootswitchHeight 5.5 cm (2.2 in)

Width 19.5 cm (7.7 in)

Length 22 cm (8.66 in)

Cable Length 6.25 m (24.5 ft)



10.3 Tip Specifications

TipLength

(mm) [in]

Inside imension (mm) [in]

Outside Dimension

(mm) [in]

Amplitude (peak to peak)

(µm) [in]Weight (g)

Curved Extended MicroTipTM 121.5 [4.783] 1.6 [0.062] 2.0 [0.077]

160 to 206 [0.0063 to 0.0081]

7.8

Curved Extended MicroTipTM Plus

192.7 [7.588] 1.6 [0.062] 2.0 [0.077]127 to 163

[0.0050 to 0.0064]9.5

Standard Tip 45.7 [1.800] 2.0 [0.078] 2.6 [0.101]127 to 163

[0.0050 to 0.0064]1.3

Curved Extended Standard Tip

114.4 [4.505] 2.0 [0.078] 2.6 [0.101]127 to 163

[0.0050 to 0.0064]7.4

Curved Extended ShearTipTM

120.5 [4.743] 1.6 [0.062] 2.3 [0.092]160 to 206

[0.0063 to 0.0081]7.9

Extended Use Curved Extended MicroTipTM 121.5 [4.783] 1.6 [0.062] 2.0 [0.077]

160 to 206 [0.0063 to 0.0081]

7.8

Extended Use Curved Extended Standard Tip

114.4 [4.505] 2.0 [0.078] 2.6 [0.101]127 to 163

[0.0050 to 0.0064]7.4

10.4 Subsystems

UltrasonicFrequency 35.55 - 36.25 kHz (frequency range)

Maximum Tip Amplitude (High Frequency Handpiece)

Up to 210 microns

Fluidic System

Irrigation Rate• The irrigation rate display shows digits 2 to 20.

• The irrigation rate is approximately:

• Normal = 2 to 20 ml/min

• Fast Flush = 25 ml/min

Suction System • Up to 640 mm (25.2 in) mercury at the pump intake at sea level.

• The suction level is lower at higher altitudes.



10.5 Handpiece

DimensionsLength 13.03 cm (5.13 in)

Diameter 2.41 cm (0.95 in)

Weight 71 g (0.15 lb)

Cable Length 463.3 cm (182.4 in)

FrequencyHigh 36 kHz

10.6 Electrical Requirements

10.6.1 Power Input and Fusing Voltage 100-240V~

Frequency 50-60Hz

Power 480VA

Phases 1

Class 1

Fuses 5A, Type T, 1500A IR, 250V, 5mm x 20mm, ceramic body

10.6.2 Power Cords

United States and Canada:

Meets hospital grade UL817

Cord 3 x 16AWG 5 Meters Color White

Console Connector C13 IEC 60320-1 V-Lock

Plug NIMA 5-15 Straight

Other Countries:

Cord 3 x 1mm2 5 Meters Color Black

Console Connector C13 IEC 60320-1 V-Lock

NOTE

Only the exact fuse type and rating is to be used. Littelfuse 0215005.HXP, 2 fuses required per console.



Plug variation by country:

Australia AS3112, Straight

Brazil NBR 14136, Straight

China GB2099, Straight

Europe CEE 7/ XVII, Straight

Italy CEI 23-50, Straight

Japan JIS 8303, Straight

South Africa SANS 164-1, Straight

Switzerland SEV Typ 12, Straight

United Kingdom BS 1363, 13A fused, Angled

Only use Integra approved power cords.

10.7 Duty Cycle

10.6.3 Maximum Low Frequency Leakage Touch current <500µA

Patient leakage current <50µA

Under maximum loading conditions, the CUSA Clarity console is suitable for ultrasonics activation times of 10 minutes on, 5 minutes off.

The system requires a minimum of one hour exposure at its operating temperature range before you use it.

See the EMC Information section, section 10.10 for further information on environmental conditions.

Electromagnetic InterferenceThe CUSA Clarity system console minimizes electromagnetic interference to other equipment used in the operating room. The system complies with the requirements of IEC 60601-1-2: 2014 Fourth Edition.

WARNING

Explosion Hazard - Do not use the CUSA Clarity System in the presence of flammable anesthetics or other volatile solvents.

WARNING

To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.



Note

Other devices in the operating room may generate electromagnetic interference. Use caution in locating equipment within the room to reduce the electromagnetic interference.

Operating

Temperature range 10°C (50°F) to 35°C (95°F)

Humidity range 30 to 85%, relative humidity, non-condensing

Atmospheric pressure range 70 kPa to 106 kPa (10.15 to 15.38 psi)

Moisture

Console Ingress Protection Rating IPX1

Storage and Shipping

Temperature range -20°C (-4°F) to 60°C (140°F)

Humidity range 15 to 85% relative humidity, non-condensing

10.8 Environment

10.9 Voluntary Standards The CUSA Clarity system meets the following standards:

• IEC 60601-1:2005 +CORR. 1:2006 + CORR.2:2007 + AM1:2012 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance, Third Edition Amendment 1

• ANSI/AAMI ES60601-1:2012 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance

• CSA C22.2 No. 60601-1:2012 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance

• IEC 60601-1-6:2010+AMD1:2013 Medical Electrical Equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability

• IEC 60601-1-8:2006+AMD1:2012 Collateral Standard - General requirements for alarm systems in Medical Electrical Equipment

• EN 60601-1-2:2007 and IEC 60601-2:2007 (3rd edition) Collateral Standard Electromagnetic Compatibility Medical Electrical Equipment

• IEC 60601-1-2:2014 (4th edition) Collateral Standard Electromagnetic Compatibility Medical Electrical Equipment

Statutory and Regulatory Classification

• Class II (FDA) Medical Device (General Controls and Special Controls)

• Class IIb (EU)

• Class III (EU)

• Class 4 (Canada)



EMC Information

Note

The CUSA Clarity system should not be used adjacent to or stacked with equipment other than the equipment specified in the CUSA Clarity Ultrasonic Surgical Aspirator System Operator’s Manual. If adjacent or stacked use is necessary, the CUSA Clarity system should be observed to verify normal operation in the configuration in which it will be used.

The use of accessories, other than the accessories specified in this manual, may result in increased emissions or decreased immunity of the CUSA Clarity system.

10.10 Guidance and Manufacturer’s Declarations

Guidance and Manufacturer’s Declaration – Electromagnetic EmissionsThe CUSA Clarity system is intended for use in the electromagnetic environment specified below.

The customer or the user of the CUSA Clarity system should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic Environment - GuidanceRF emissions

CISPR 11

Group 1The CUSA Clarity system uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions

CISPR 11Class A The CUSA Clarity system is suitable for use in a hospital environment.

Harmonics emissions

IEC 61000-3-2Not Applicable

Not applicable for hospital environmentsVoltage fluctuations / flicker emissions

IEC 61000-3-3

Not Applicable



Guidance and Manufacturer’s Declaration – Electromagnetic ImmunityThe CUSA Clarity system is intended for use in the electromagnetic environment specified below.


IMMUNITY TestIEC 60601-1-2

Test LevelCompliance Level

Electromagnetic Environment - Guidance

Electrostatic discharge (ESD)

IEC 61000-4-2

± 6 kV contact (3rd ed.) ± 8 kV contact (4th ed.)

± 8 kV air (3rd ed.)

± 15 kV contact (4th ed.)

± 8 kV contact

± 15 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast

transient/burst

IEC 61000-4-4

± 2 kV for power supply lines

± 1 kV for input /

output lines

± 2 kV for power supply lines

± 1 kV for input /

output lines

Mains power quality should be that of a typical hospital environment.

Surge

IEC 61000-4-5

± 1 kV line(s) to line(s)

± 2 kV line(s) to earth

± 1 kV line(s) to line(s)

± 2 kV line(s) to earthMains power quality should be that of a typical hospital environment.

Voltage dips, short interruptions and voltage

variations on power supply input lines.

IEC 61000-4-11

< 5% UT (> 95% dip in UT)

for 0,5 cycle

< 40 % UT (> 60% dip in UT)

for 5 cycles

< 70 % UT (> 30% dip in UT)

for 25 cycles

< 5% UT (> 95% dip in UT)

for 5 s

< 5% UT (> 95% dip in UT)

for 0,5 cycle

< 40% UT (> 60% dip in UT)

for 5 cycles

<70% UT (> 30% dip in UT)

for 25 cycles

< 5% UT (> 95% dip in UT)

for 5 s

Mains power quality should be that of a typical hospital environment.

If the user of the CUSA Clarity system requires continued operation during power mains interruptions, it is recommended that the CUSA Clarity system be powered from an uninterruptible power supply.

Power frequency

(50/60 Hz) magnetic field

IEC 61000-4-8

3 A/m (3rd ed.)

30 A/m (4th ed.)30 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical hospital environment.

Note

UT is the a.c. mains voltage prior to application of the test level.



Guidance and Manufacturer’s Declaration – Electromagnetic ImmunityThe CUSA Clarity system is intended for use in the electromagnetic environment specified below.


IMMUNITY TestIEC 60601 Test Level

Compliance LevelElectromagnetic Environment

- Guidance

Portable and mobile RF communications equipment should be used no closer to any part of the system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance:

Conducted RF Immunity

IEC 61000-4-6

3 Vrms

150 kHz to 80 MHz (3rd and 4th ed.)

6 Vrms in ISM and amateur radio

bands (4th ed.)

3 Vrms150 kHz to 80 MHz

6 Vrms in ISM and amateur

radio bands

80 MHz to 800 MHz

800 MHz to 2.7 GHz

Radiated RF Immunity

IEC 61000-4-3

3 V/m

80 MHz to 2.5 GHz (3rd ed.)

80 MHz to 2.7 GHz (4th ed.)

3 V/m

80 MHz to 2.7 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb.

Interference may occur in the vicinity of equipment marked with the following symbol:

d =1,2P

d =1,2P

d =2,4P

Note

At 80 MHz and 800 MHz, the higher frequency range applies.

Note

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.



Note

At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

Note

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the CUSA Clarity System

The CUSA Clarity system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the CUSA Clarity system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CUSA Clarity system as recommended below,

according to the maximum output power of the communications equipment.

Rated Maximum Output Power of Transmitter W

Separation Distance According to Frequency of Transmitter m

150 kHz to 80 MHzd =1,2P

80 MHz to 800 MHzd =1,2P

800 MHz to 2.7 GHzd =2,4P

0.01 0.12 m 0.12 m 0.24 m

0.1 0.38 m 0.38 m 0.76 m

1 1.2 m 1.2 m 2.4 m

10 3.8 m 3.8 m 7.6 m

100 12 m 12 m 24 m

For transmitters rated at maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the CUSA Clarity system is used exceeds the applicable RF compliance level above, the CUSA Clarity system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orientating or relocating the CUSA Clarity system.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.



11.1 Ordering Replacement Parts

US Service Center

Integra Neurosciences

5965 Pacific Center Blvd

Suite 705

San Diego, CA 92121

Tel 858-815-1115 Option 5

Fax: 858-455-5874

E-mail: [email protected]

Europe, Middle East and Africa Service Center

Integra Neurosciences GmbH

Halskestrasse 9

Ratingen 40880

Germany

Tel: +49 2102 5535 6150

Fax: +49 2102 942 4872


Asia Pacific Service Center

Integra NeuroSciences Pty. Ltd.

Unit 3, 24-30 Winterton Road

CLAYTON, VIC. 3168, Australia

Tel: +613 85400400

Fax: +613 95400004


Chapter 11 - Replacement Parts

11.2 Field Replacement Part list

Item Part from Part Status Description Unit Qty/Unit

S215100084 CUSA® Clarity console Field Replacement Part Fuse (5A) Each 2

S30905284 CUSA® Clarity console Field Replacement Part CUSA® Clarity IV Pole Sub-Assembly Each 1

S72905007 CUSA® Clarity Cart Field Replacement Part CART BASE PLATE, PHOENIX Each 1

S72905009 CUSA® Clarity Cart Field Replacement Part VACUUM CANISTER HOLDER, PHOENIX Each 1

S72905051 CUSA® Clarity Cart Field Replacement Part CART WEIGHT COVER, PHOENIX Each 1

S72905053 CUSA® Clarity Cart Field Replacement Part FOOTSWITCH BASKET, PHOENIX Each 1

S72905054 CUSA® Clarity Cart Field Replacement Part CART CABLE WINDING PEG, PHOENIX 2 pair 1

S72905055 CUSA® Clarity Cart Field Replacement Part CASTER, PHOENIX 1 set of 4 1

S72905056 CUSA® Clarity Cart Field Replacement Part CASTER BUMPER, PHOENIX 1 set of 4 1

S72905103 CUSA® Clarity Cart Field Replacement Part HEX L-KEY, 6mm Each 1



Item Part from Part Status Description Unit Qty/Unit

S72905320 CUSA® Clarity Cart Field Replacement Part SOCKET HEAD CAP SCREW, M8x60 Each 2

S72905321 CUSA® Clarity Cart Field Replacement Part M8 EXTERNAL TOOTH LOCK WASHER Each 1

S72905358 CUSA® Clarity Cart Field Replacement Part SCREW, SOCKET HEAD CAP, M8x50 MM Each 4

S72905359 CUSA® Clarity Cart Field Replacement Part WASHER, EXTERNAL TOOTH, M8 Each 1

S72905360 CUSA® Clarity Cart Field Replacement Part SCREW, FLAT-HEAD SOCKET CAP, M6X12 MM Each 2

S72905361 CUSA® Clarity Cart Field Replacement Part WASHER, EXTERNAL TOOTH, M6 Each 1

S72905362 CUSA® Clarity Cart Field Replacement Part SCREW CAP, GRAY, M5/M6 Each 2

S72905364 CUSA® Clarity Cart Field Replacement Part SCREW, BUTTON HEAD CAP, M6X10 MM Each 3

S72905365 CUSA® Clarity Cart Field Replacement Part SCREW, BUTTON HEAD CAP, M6X12 MM Each 1

S72905366 CUSA® Clarity Cart Field Replacement Part COVER, WINDING PEG, CART, PHOENIX 2 pair 1

S72905368 CUSA® Clarity Cart Field Replacement Part WASHER, LOCK, M6 Each 1

S72905369 CUSA® Clarity Cart Field Replacement Part SCREW, SOCKET HEAD CAP, M6X12 MM 2 pair 1

S72905370 CUSA® Clarity Cart Field Replacement Part LABEL, MAX LOAD, CART WEIGHT COVER, PHOENIX Each 1

S72905371 CUSA® Clarity Cart Field Replacement Part SCREW, SHEET METAL, 6.3X16 MM Each 4

S72905383 CUSA® Clarity Cart Field Replacement Part WASHER, FLAT, M12 Each 1

S72905393 CUSA® Clarity Cart Field Replacement Part WASHER, M6 Each 2

S72905363 CUSA® Clarity Cart Field Replacement Part SPRING NUT, M6 Each 10

S72904552 CUSA® Clarity Other Field Replacement Part POWER CORD, V-LOCK, US Each 1

S72904553 CUSA® Clarity Other Field Replacement Part POWER CORD, V-LOCK, EURO Each 1

S72904554 CUSA® Clarity Other Field Replacement Part POWER CORD, V-LOCK, UK Each 1

S72904555 CUSA® Clarity Other Field Replacement Part POWER CORD, V-LOCK, AUSTRALIA Each 1

S72904556 CUSA® Clarity Other Field Replacement Part POWER CORD, V-LOCK, BRAZIL Each 1

S72904557 CUSA® Clarity Other Field Replacement Part POWER CORD, V-LOCK, ITALY Each 1

S72904558 CUSA® Clarity Other Field Replacement Part POWER CORD, V-LOCK, SOUTH AFRICA Each 1

S72904559 CUSA® Clarity Other Field Replacement Part POWER CORD, V-LOCK, SWITZERLAND Each 1

S72904560 CUSA® Clarity Other Field Replacement Part POWER CORD, V-LOCK, CHINA Each 1

S72904561 CUSA® Clarity Other Field Replacement Part POWER CORD, V-LOCK, JAPAN Each 1



Intentionally Blank



12.1 Overview

Integra LifeSciences Corporation and its wholly owned subsidiaries (“Integra”) warrant to Integra authorized distributors and to the original purchaser only that each new Integra® CUSA® Clarity Ultrasonic Surgical Aspirator System (“CUSA® Clarity”) is free from defects in materials and workmanship under normal use and service for a period of one (1) year from the date of delivery (“Warranty Period”) by Integra to the original purchaser, but in no event beyond the expiration date stated on any product labeling (hereinafter the Warranty Period). For the purpose of products sold by Integra through an Integra-authorized distributor, “original purchaser” shall mean the purchaser of Integra products to whom an Integra-authorized distributor first sells the product. The original purchaser is hereinafter referred to as Customer.

12.2 Coverage

During the Warranty Period, Integra shall provide free-of-charge service and maintenance consistent with the provisions of Section 3 of this Warranty, so that the Equipment conforms to the specifications defined in the CUSA® Clarity Operator’s Manual; as such Operator’s Manuals may be modified by Integra from time to time (the “Specifications”).

12.3 Exclusions

The Warranty shall not apply in any manner to service or maintenance of the Equipment, or to replacement of its parts, with respect to:

• use of Equipment with any tips, flues, and cartridge and tubing sets and accessories other than those manufactured by Integra LifeSciences;

• defects arising out of materials or parts provided, modified, or designed by anyone other than an authorized Integra service agent (the “Integra Service Agent”);

• defects emanating from improper or negligent installation, storage, or use of the Equipment or any component thereof, including but not limited to operating the Equipment not in accordance with instructions provided in the Operator’s Manual;

• defects arising from improper or negligent cleaning or sterilization methods or improper maintenance of the Equipment;

• defects resulting from repairs or service of the Equipment provided other than by Integra or its authorized representatives;

• defects arising from accidental damage to the Equipment, acts of God, electrical power damage, equipment malfunction, unusual stress, unreasonable operating procedures, or abnormal or extreme operating conditions;

• normal wear and tear.

12.4 Service, Repairs, and Replacement

All service and repairs covered by this Warranty may be referred to hereinafter as “in-warranty repairs,” and all service and repairs not covered by this Warranty may be referred to as “out-of-warranty repairs.” Integra’s sole obligation for in-warranty repairs shall be to make all necessary adjustments and repairs in accordance with this Warranty. Integra shall charge Customer at Integra’s then-standard rates for any out-of-warranty repair performed by Integra.

Equipment Replacement. The defective Equipment or part thereof that is replaced in accordance with the Warranty shall be the property of Integra. Integra reserves the right to fill spare parts requests using refurbished sub-assemblies provided that such sub-assemblies are functionally equivalent to new sub-assemblies and carry the same warranty as the replaced sub-assemblies.

Notification. In order to avail itself of its rights under the Warranty, Customer or Integra authorized distributors, must immediately notify Integra of any defects and provide Integra every opportunity to inspect and remedy defects.

Chapter 12 - Warranty



12.5 Repair Parts and Services

Included under the Warranty are the following services:

Consoles. Integra or its distributor, when authorized for this purpose, shall, if possible, perform on-site repair of consoles and where not possible or otherwise decided at the sole discretion of Integra, Integra or its distributor shall arrange and pay to ship the affected Equipment to the designated repair facility. Integra or its distributor authorized for this purpose shall repair the affected Equipment or replace a console by a new or refurbished console (at the discretion of Integra), that shall carry the same remaining warranty as the original equipment.

Handpieces. Integra shall repair or replace any defective handpiece covered by the Warranty by a new or refurbished handpiece (at the discretion of Integra) that shall carry the same remaining warranty as the original equipment.

Modifications to Covered Equipment. From time to time, at its sole discretion, Integra may propose modifications to the covered Equipment and to the Specifications for the Equipment. Subject to Customer’s approval and at its sole expense, the Customer may request Integra to make such modifications to the covered Equipment and to the Specifications. Integra shall make such modifications for the Customer, which modifications may include the installation of new parts in the Equipment, at a price equal to the then-current list price for such modifications, as such list price is established by Integra in its sole discretion.

12.6 Quality Control

Customer shall maintain reasonable standards of quality control, operations, procedures, safety testing and inspection of Equipment to ensure that unnecessary service or maintenance is not required hereunder.

Customer shall provide a technical counterpart to Integra’s Service Agent for assistance in Integra’s telephonic diagnosis of the malfunction with the Equipment. Customer shall reasonably accept Integra’s determination whether a repair or service is an in-warranty repair or an out-of-warranty repair.



12.7 Limitation of Liability

Integra’s only responsibility under the warranties described in Section 1 shall be repair or replacement, at Integra’s option and election, of any Integra product (or part thereof) that Integra reasonably determines to be covered by this warranty and to be defective in workmanship or materials. Repair or replacement of products under this warranty does not extend the warranty period.

THE WARRANTIES DESCRIBED IN SECTION 1 HEREOF ARE EXCLUSIVE AND ARE GIVEN AND ACCEPTED IN LIEU OF ALL OTHER WARRANTIES OF INTEGRA OR ITS SERVICE AGENTS WITH RESPECT TO THE QUALITY, PERFORMANCE AND OPERATION OF THE EQUIPMENT, WRITTEN OR ORAL, EXPRESSED OR IMPLIED, AND WHETHER OR NOT ATTRIBUTABLE TO SERVICE PERFORMED PURSUANT TO THE WARRANTY. INTEGRA DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE EQUIPMENT OR THE SERVICES, DIAGNOSES, ADVICE, ASSISTANCE OR PARTS TO BE TENDERED PURSUANT TO THE WARRANTY, INCLUDING, BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, AND ANY IMPLIED WARRANTY ARISING FROM COURSE OF PERFORMANCE, COURSE OF DEALING, USAGE OR TRADE OR OTHERWISE, OR APPLIACTION OR WARRANTY OF QUALITY AS WELL AS ANY EXPRESS OR IMPLIED WARRANTY TO PATIENTS.

Further, this warranty shall not apply to, and Integra shall not be responsible for, any loss arising in connection with the purchase or use of any Integra product that has been repaired by anyone other than an authorized Integra service representative or altered in any way so as, in Integra’s sole judgment, to affect its stability or reliability, or which has been subject to misuse, negligence or accident, or which has been used other than in accordance with the instructions furnished by Integra.

IN NO EVENT SHALL INTEGRA, ITS AFFILIATES, ASSIGNEES OR SERVICE AGENTS BE LIABLE FOR ANY INCIDENTAL, INDIRECT, CONSEQUENTIAL, SPECIAL OR PUNITIVE DAMAGES IN CONNECTION WITH THE ACQUISITION OR USE OF ANY INTEGRA PRODUCT, OR OF LOSS OF USE, REVENUE OR PROFIT, WHETHER ARISING IN CONTRACT OR IN TORT, BY VIRTUE OF THE WARRANTY OR ANY PERFORMANCE OR BREACH BY INTEGRA, ITS AFFILIATES, ASSIGNEES OR SERVICE AGENTS HEREUNDER OR PURSUANT HERETO.

Customer agrees that, notwithstanding the technical assistance provided pursuant to the Warranty by Integra or its representatives, Customer shall be fully responsible for all treatments performed or attempted with the Equipment.

INTEGRA MAKES NO REPRESENTATION OR WARRANTY AS TO THE EFFICACY OF THE EQUIPMENT OR OF THE TECHNICAL ASSISTANCE TO BE RENDERED BY INTEGRA, ITS AFFILIATES, ASSIGNEES OR SERVICE AGENTS, FOR PURPOSES OF THE PARTICULAR TREATMENT THAT CUSTOMER UNDERTAKES TO PERFORM FOR THIRD PARTIES.

Moreover, Customer shall not make any claim against Integra or any of its affiliates, assignees or representatives with respect to the efficacy of the Equipment or of said technical assistance or with respect to any claims by third parties related to any treatment undertaken by Customer.

Force Majeure. Notwithstanding anything to the contrary herein contained, if the performance of the Warranty by Integra or Customer or any obligation of Integra or Customer hereunder is prevented, restricted or interfered with by reason of fire, explosion, act of God, labor disputes or accidents affecting performance under the Warranty, or war, mobilization, civil commotions, blockade or embargo, or any future law, regulation, ordinance or requirement of any government or regulatory agency or any other act, whatsoever similar to those above enumerated, or any other circumstance being beyond the reasonable control of Integra or Customer, then and in that event Integra or Customer, as the case may be, shall promptly notify the other party hereto of the resulting difficulties therefrom, and any of the foregoing events shall excuse any performance required under the Warranty



1.0 Purpose

This procedure provides a method to conduct CUSA® Clarity Safety test according IEC 62353.

2.0 Scope

This document covers CUSA® Clarity Safety test according IEC 62353.

3.0 Responsibility

Trained personnel shall perform this test.

Global Service & Repair is responsible for updating and maintaining this procedure.

4.0 Reference Documents

CUSA® Clarity Service and Repair Work Instruction (60905375) - Rev A

5.0 Equipment

Appendix A:Integra Global Service & Repair Test Procedures (IT0738 & IT0739) and Test Data Sheets

Test Procedure IT0738CUSA®Clarity GS&R Safety Test Procedure

Issued: 19 Jan 2017

Equipment Description

CUSA® Clarity console system (DUT) Integra Ref. C7000

Footswitch Integra Ref. C7002


CUSA® Clarity 36 kHz Curved Ext MicroTip (Single Pack) Integra Ref. C7414

CUSA® Clarity Quick Connect Tubing Set (Single pack) Integra Ref. C7300EA


CUSA® Clarity 36 kHz Sterilizable Torque Base EACH1 Integra Ref. C7636

Tip torque wrench (36 kHz) Integra Ref. C7602


Jar of water Any kind of 1 liter


Safety Analyzer Rigel 288 or Rigel 62353 or Fluke ESA620 or equivalent (which have IEC 62353 measurement capability)



Prerequisites

Before performing this protocol, record the serial number, calibration due date for all calibrated equipment and other required data in the test datasheet IT0738A.

6.0 Test Conditions

The tests may be performed at the ambient temperature, humidity, atmospheric pressure and mains voltage as present at the site of testing.

7.0 Normalization Instructions

As this test is performed at actual mains voltage present at the site of testing, measurement result have to be normalized before comparing with acceptance criteria. The normalization will be done according the formula:

Voltage Rated Value

actual mains voltage

Frequency Rated Value

actual mains frequencyEquipment Leakage Current = x actual Leakage Current x

8.0 Earthing System

Retrieve information related to the earthing system (grounding system) of the electricity supply systems of the location where the test will be conducted. It could be TN-System or IT-System. IT-System is commonly found in Operating Room environment and TN-System is mainly found in workshop or biomedical workshop environment.

Depend on the earthing system, different measuring methods will be applicable for leakage currents measurements and will be described in the following paragraphs.

The Rigel 288 informs the user when the test is performed under IT-System network by the following message.

Note

This instruction of test is developed to be conduct with Rigel 288 Safety Analyzer. Using another Safety Analyzer model may require some adaptations.



In this condition, EQUIPMENT LEAKAGE CURRENT and APPLIED PART LEAKAGE CURRENT must be done with Alternative method.

9.0 Measurements of Mains Voltage

• With the DMM, measure the mains voltage between phase and neutral lines as well as frequency.

• Record the values in IT0738A.

10.0 Measurements of Protective Earth Resistance

• Record in IT0738A if the main lead is original provided with the Clarity console.

• The Safety Analyzer is connected directly to the mains (TN-System or IT-System).

• The DUT (Device Under Test) mains lead is connected to mains socket on the Rigel 288.

• The earth bond lead is connected from the black 4 mm plug to alternatively 3 different connections on the Clarity console as detailed in the table below.

• From the Rigel 288 main menu, select Manual Mode –> Earth Bond as shown below:

• Execute the protective earth resistance measurement for each connection below by pressing the green button:

o During the measurement, the main cord shall be flexed along its length. If during the flexing, changes in resistance are observed, it shall be assumed that the protective earth conductor is damaged or the connections are no longer adequate.


Equipotential Earth Ground Ω ≤ 300 mΩ

Cartridge Door Ω ≤ 300 mΩ

Handpiece Socket Connector Ω ≤ 300 mΩ

• Record values in IT0738A.

11.0 Measurements of Equipment Leakage Current11.1 TN-System (Direct method)

• The Safety Analyzer is connected directly to the mains (TN-System only).


• Fit a handpiece, the footswitch, the aspiration and irrigation tubing kit, waste canister, etc. to the console.

• Attached the crocodile clip from the safety tester lead (Applied Part module port 1) to the proximal end of the tip (without the flue).

• Attached the test lead from the safety tester (Applied Part module port 2) to the Equipotential Earth Ground pin of the console.



• From the Rigel 288 main menu, select Manual Mode –> IEC62353 –> Equipment Leakage Test –> Direct as shown below:

• Press Button and set the Test Duration to (time) unlimited. Press Button to exit Settings mode without saving changes.

• Press the green button to allow power on the DUT (Device Under Test) and start measurement.

• Turn on the DUT and wait for the GUI to load.

• Prime the irrigation tubing and perform a handpiece test in order to access the main menu.

• On the DUT main menu, set up the system as follows:

o AMPLITUDE to 100%

o ASPIRATION to 100%

o IRRIGATION to 2ml/min

o TISSUE SELECT to OFF

• Press the footswitch Vibrate pedal (orange pedal) fully down, to achieve maximum stroke.

• Read from the Rigel leakage current value.

• Turn off the DUT (Device Under Test) and wait for the system is completely off.

• Normalize the measured value according paragraph 7.0 Normalization instructions and record the test result in IT0738A.

11.2 IT-System (Alternative method)

• The Safety Analyzer is connected directly to the mains (IT-System only).


• Connect the handpiece and the footswitch.


• Attached the test lead from the safety tester (Applied Part module port 2) to the Equipotential Earth Ground pin of the console.

• From the Rigel 288 main menu, select Manual Mode –> IEC62353 –> Equipment Leakage Test –> Alternative as shown below:

• Execute the EQUIPMENT LEAKAGE CURRENT measurement by pressing green button.

• A Warning message as described in paragraph 8.0 Earthing system appears on the Rigel 288 screen to inform the user that the test is performed under IT-System network. Press the green button again to perform the test.

• Normalize measured value according paragraph 7.0 Normalization instructions and record the test result in IT0738A.



12.0 Measurements of Applied Part Leakage Current12.1 TN-System (Direct method)

• The Safety Analyzer is connected directly to the mains (TN-System only).


• Fit a handpiece, the footswitch, the aspiration and irrigation tubing kit, waste canister, etc. to the console.


• From the Rigel 288 main menu, select Manual Mode –> IEC62353 –> AP Leakage Test –> Direct as shown below:

• Press Button and set the Test Duration to (time) unlimited. Press Button to exit Settings mode without saving changes.

• Press the green button to allow power on the DUT (Device Under Test) and start measurement.

• Turn on the DUT and wait for the GUI to load.

• Prime the irrigation tubing and perform a handpiece test in order to access the main menu.

• On the DUT main menu, set up the system as follows:

o AMPLITUDE to 100%

o ASPIRATION to 100%

o IRRIGATION to 2ml/min

o TISSUE SELECT to OFF

• Immerse the full tip into a jar feed with 1 liter of water to load the handpiece.

• Press the footswitch Vibrate pedal (orange pedal) fully down, to achieve maximum stroke.

• Read from the Rigel leakage current value.

• Turn off the DUT (Device Under Test) and wait for the system is completely off.




12.2 IT-System (Alternative method)

• The Safety Analyzer is connected directly to the mains (IT-System only).


• Connect the handpiece and the footswitch.


• From the Rigel 288 main menu, select Manual Mode –> IEC62353 –> AP Leakage Test –> Alternative as shown below:

Issue ECO Description Updated by Date

1 Initial release Jean-Luc Billard 26 Oct. 2016

2 Add to check & record if test is performed with original main lead Jean-Luc Billard 19 Jan 2017

• Execute the APPLIED PART LEAKAGE CURRENT measurement by pressing green button.

• A Warning message as described in paragraph 8.0 Earthing system appears on the Rigel 288 screen to inform the user that the test is performed under IT-System network. Press the green button again to perform the test.


13.0 Revision History



Equipment Equipment Type Serial Number / ID Number

Calibration Due Date

Footswitch Integra Ref. C7002 N/A

CUSA® Clarity 36 kHz Handpiece Integra Ref. C7036 N/A

CUSA® Clarity 36 kHz Curved Ext MicroTip (Single Pack) Integra Ref. C7414 N/A

CUSA® Clarity Quick Connect Tubing Set (Single Pack) Integra Ref. C7300EA N/A N/A

Contamination guard Integra Ref. C7005 N/A N/A

CUSA® Clarity 36 kHz Sterilizable Torque Base EACH1 Integra Ref. C7636 N/A N/A

Tip torque wrench (36 kHz) Integra Ref. C7602 N/A N/A

Waste canister Bemis BEH484410 or equivalent N/A N/A

Jar of water Any kind of 1 liter N/A N/A


Safety Analyzer Rigel 288 or Rigel 62353 or Fluke ESA620 or equivalent (which have IEC 62353 measurement capability)

Test Procedure IT0738A

CUSA® Clarity GS&R Safety Test Datasheet

Issued: 27 Oct 2016Console S/N: _____________________ Service Order :_________________

Measurement of Mains voltage Result

With the DMM, measure the mains voltage between phase and neutral line

With the DMM, measure the mains frequency between phase and neutral line

Measurement of Protective Earth Resistance Result Expected value Pass Fail

Is Mains lead original provided with the Clarity console? Yes/No N/A N/A

Equipotential Earth Ground pin ≤ 300 mΩ

Cartridge Door ≤ 300 mΩ

Handpiece Socket Connector ≤ 300 mΩ

Measurement of Equipment Leakage Current TN-System (Direct method)

Result Expected value Pass Fail N/A

Equipment Leakage Current ≤ 500 µA

Measurement of Equipment Leakage CurrentIT-System (Alternative method)


Equipment Leakage Current ≤ 1000 µA

Measurement of Applied Part Leakage Current TN-System (Direct method)


Applied Part Leakage Current ≤ 50 µA

Measurement of Applied Part Leakage CurrentIT-System (Alternative method)


Applied Part Leakage Current ≤ 50 µA

Tested by (Sign and Date): __________________________ dd/mm/yyyy___________

REV ECO DESCRIPTION UPDATED BY DATE


2 Add to check & record if test is performed with original main lead Jean-Luc Billard 19 Jan. 2017



1.0 PurposeThis procedure provides a method for testing functionality of the CUSA® Clarity with the minimum test equipment that can be handled by customer

2.0 ScopeThis document covers the final functional test of the CUSA® Clarity Console.

3.0 ResponsibilityTrained personnel shall perform this test.

Global Service & Repair is responsible for updating and maintaining this procedure.

4.0 Reference Documents

CUSA® Clarity System Service and Repair Work Instruction

5.0 Equipment

Test Procedure IT0739

CUSA® Clarity End User Functional Test

Issued: 27 Oct 2016

Equipment Description

CUSA® Clarity console system (DUT) Integra Ref. C7000

Footswitch Integra Ref. C7002


CUSA® Clarity 36 kHz Curved Ext MicroTip(Single Pack) Integra Ref. C7414

CUSA® Clarity Quick Connect Tubing Set(Single pack) Integra Ref. C7300EA


CUSA® Clarity 36 kHz Sterilizable Torque Base EACH1 Integra Ref. C7636

Tip torque wrench (36 kHz) Integra Ref. C7602

Handheld digital tachometer Testo 470

Reflective tape for the digital tachometer RS Component P/N: 845-9731

T connector RS Component P/N: 795-405



PrerequisitesBefore performing this protocol, record the serial number, calibration due date for all calibrated equipment and other required data in the test datasheet IT0739A.



6.0 Test conditionsThe tests may be performed at the ambient temperature, humidity, atmospheric pressure and mains voltage as present at the site of testing.

7.0 Visual inspectionVisually inspect the console for signs of damage which would affect the normal operation and function of the system.

Check the following items:

1. Carefully inspect the console for scratches on front and rear component as well as the metal cover.

2. Inspect the IV Pole at the rear side for damage and check its functionality.

3. Check that all four rubber feet are in place and not damaged.

4. Inspect for cracks or damage to touch screen display.

5. Check irrigation door for damage and check it is opening and closing smoothly.

6. Check irrigation pump head and rollers for damage.

7. Check pinch valve for damage.

8. Check contamination guard for moisture or blood.

9. Check condition the AC power cord returned with the console.

10. Check connectors for damage and proper orientation.

11. Check all labels and confirm that they are in good condition, legible, and firmly attached (no curled or loose edges).

12. Inspect for scratches or damage to foot-pedal.

13. Inspect for cracks or damage to handpiece and its cord and connector if available.

14. Inspect console to cart attachment.

15. Inspect cart for damage.

a. Inspect Base Plate for cracks or damage.

b. Inspect Vacuum Canister for cracks or damage.

c. Inspect Cart Foot Switch for cracks or damage.

d. Inspect Cart Cable Peg for cracks or damage.

e. Inspect Cart Weight Cover for cracks or damage.

16. Inspect Cart Weight Cover for cracks or damage.

17. Inspect cart wheels for proper rotation and direction.

Record results in IT0739A.

8.0 Electrical Safety Tests• Conduct Electrical Safety test according to IT0738.

• Record in IT0739A that the Electrical Safety test passed.

9.0 Functional Test

9.1 Test Setup• Turn on the console.

• Connect the Footswitch and the CUSA® Clarity 36 kHz Handpiece.

• Connect a contamination guard on the console and connect the canister.

• Open the cartridge door and stick the reflective tape on the border of the pump head



• Place the cartridge on the pump head, close the door and connect the aspiration tubing set to the canister.

• Attach the T connector in line between the distal end of the aspiration tubing set and the handpiece suction port.

• Connect the 3rd port of the T connector to the Digital Manometer.

• From the Setup task menu press Start Prime button. Wait until the prime is completed.

9.2 Ultrasound Test• From the Setup task menu press Start Test button.

• When the test is completed, press Details button.

• Record in IT0739A that the Tip Frequency Optimization Test passed.

• Record in IT0739A the percentage Amplitude.

9.3 Irrigation Test• Press Main screen button.

• Position Aspiration Mode on Constant position.

• Position the digital tachometer in front of the cartridge door’s whole.

• Select Irrigation at 2 ml/min.

• Measure the speed of the pump head through the irrigation door hole. Record the value. Expected value from 2 to 8 RPM.

• Press fast flush pedal.

• Measure the speed of the pump head through the irrigation door hole. Expected value from 34 to 47 RPM. Record values in IT0739A.

9.4 Aspiration Test• From Main screen select Aspiration Mode on Constant position.

• Set aspiration at 100%.

• Measure with Digital Manometer the Aspiration. Expected value from 304 to 436 mmHg. Record values in IT0739A.

10.0 Acceptance CriteriaAll values must be within the above specifications. If not, the unit will be sent to Service for repair.





Equipment Equipment Type Serial Number / ID Number

Calibration Due Date

CUSA® Clarity 36 kHz Integra Ref. C7036 N/A

CUSA® Clarity 36 kHz Curved Curved Ext MicroTip(Single Pack)

Integra Ref. C7414 N/A

Handheld digital tachometer Testo 470


Test Procedure IT0739A

CUSA® Clarity End User Functional Test Datasheet

Issued: 27 Oct 2016

Console S/N: _____________________ Service Order :_________________

Visual Inspection Pass Fail N/A

1 Carefully inspect the console for scratches on front and rear component as well as the metal cover.

2 Inspect the IV Pole at the rear side for damage and check its functionality.

3 Check that all four rubber feet are in place and not damaged.

4 Inspect for cracks or damage to touch screen display.

5 Check irrigation door for damage and check it is opening and closing smoothly.

6 Check irrigation pump head and rollers for damage.

7 Check pinch valve for damage.

8 Check contamination guard for moisture or blood.

9 Check condition the AC power cord returned with the console.

10 Check connectors for damage and proper orientation.

11 Check all labels and confirm that they are in good condition, legible, and firmly attached (no curled or loose edges).

12 Inspect for scratches or damage to foot-pedal.

13 Inspect for cracks or damage to handpiece and its cord and connector if available.

14 Inspect console to cart attachment.

15

Inspect cart for damage

a. Inspect Base Plate for cracks or damage

b. Inspect Vacuum Canister for cracks or damage

c. Inspect Cart Foot Switch for cracks or damage

d. Inspect Cart Cable Peg for cracks or damage

e. Inspect Cart Weight Cover for cracks or damage

16 Inspect Cart Weight Cover for cracks or damage.

17 Inspect cart wheels for proper rotation and direction.

Electrical Safety Tests Pass Fail



Ultrasound Test Result Expected value Pass Fail

Tip Frequency Optimization N/A N/A

Amplitude Test > 50%

Irrigation Test Result Expected value Pass Fail

Select Irrigation at 2 ml/min 2 to 8 RPM

Press fast flush pedal 34 to 47 RPM

Aspiration Test Result Expected value Pass Fail

Set aspiration at 100% 304 to 436 mmHg

Tested by (Sign and Date): __________________________ dd/mm/yyyy___________





Intentionally Blank



Appendix B: Serial Number Nomenclature

Use the serial number to determine the manufacture date and age of the console. All CUSA® Clarity Systems have a 12-digit serial number. The descriptions and meanings of serial number digits is below.

Serial Number Format (12 Digits)

X1 X2 X3 X4 X5 X6 X7 X8 X9 X10 X11 X12

Prod

uct G

roup

Prod

uct T

ype

Mon

th o

f Man

ufac

turin

g

Year

of M

anuf

actu

ring

Uni

t Num

ber

Mod

ifica

tion

Stat

e

Man

ufac

turin

g Pl

ant

X1 Product Group

Group Identifier

CUSA® Clarity C

X2 Product Type

Group Type Identifier

CUSA® Clarity

Console H

Handpiece 23kHz K

Handpiece 36 kHz L

Cart M

X3 Month of Manufacturing

Month Identifier

JANUARY A

FEBRUARY B

MARCH C

APRIL D

MAY E

JUNE F

JULY G

AUGUST H

SEPTEMBER J

OCTOBER K

NOVEMBER L

DECEMBER M

X4 & X5 Year of Manufacturing

Two digit number representing year e.g. 2016 = 16, 2017 = 17, 2018 = 18, 2019 = 19 etc.



X6, X7, & X8 Unit Number

Sequential number starting at 001 at the beginning of each month uniquely identifies the unit.

X6, X7, & X8 Unit Number

Two-digit number representing modification state e.g. 01, 02 etc. Generally, the modification state changes when there is a change to the form, fit or function of components used in the system and traceability is required.

Group Type Modification Number

CUSA® Clarity Console 01 Baseline

X11 & X12 Manufacturing Plant

Plant Identifier

Integra LifeSciencesSragh Industrial EstateTullamore, Co OffalyIreland

IE

CUSA® Clarity Serial Number Example

C H F 1 6 0 0 1 0 1 I E

Product Group C: CUSA® Clarity

Product Type H: Console

Month of Manufacture F: June

Year of Manufacture 16: 2016

Unit Number 001: 001 (First unit built in June)

Modification State 01: 01

Manufacturing Plant IE: Integra LifeSciences, Ireland



Integra LifeSciences (Ireland) LimitedIDA Business &Technology ParkSraghTullamoreCounty OffalyIreland

USA & Canada: (800) 997-4868 Outside USA: (609) 936-5400

www.integralife.com

Manufacturer