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General| Category | Medical Equipment |
|---|---|
| Manufacturer | Integra LifeSciences |
| Frequency | 23 kHz |
| Amplitude Range | 0-100% |
| Power Requirements | 100-240 VAC, 50/60 Hz |
| Technology | Ultrasonic |
| Type | Ultrasonic Aspirator |
Defines the target users of the manual and the equipment.
Lists registered trademarks of Integra and other companies.
Provides contact details for the manufacturer.
Lists relevant patent numbers for the system.
Explains the structure and content of the operator's manual.
Highlights key components and functionalities of the CUSA Clarity system.
Explains how to effectively use the manual for reference and training.
Explains symbols, warnings, cautions, and notes used in the document.
Details the surgical procedures for which the CUSA Clarity system is indicated.
Specifies conditions or uses for which the system is not indicated.
Defines the qualified medical professionals authorized to use the system.
Provides essential general safety information for operating ultrasonic surgery equipment.
Lists critical safety warnings and cautions for system operation.
Explains the system's classifications and the meaning of various console symbols.
Introduces the topics covered in the system introduction section.
Describes the CUSA Clarity system and its three primary functions.
Lists and describes the main components of the CUSA Clarity system.
Lists and describes the various accessories used with the CUSA Clarity system.
Explains the electromechanical operation that causes tissue fragmentation.
Describes the system's irrigation fluid delivery mechanism.
Explains how the system performs aspiration or suction.
Introduces the system's touchscreen interface and its layout.
Describes the handpiece, its connection, and its basic functions.
Lists the three main functions performed by the handpiece.
Details handpiece configurations and the variety of available surgical tips.
Explains the Tissue Select feature for enhanced control and selectivity.
Elaborates on how fragmentation occurs through tip vibration and tissue interaction.
Discusses inherent tissue selectivity and how tissue strength affects fragmentation.
Explains methods to increase tissue selectivity by adjusting system parameters.
Details the five available settings for the Tissue Select feature.
Outlines the sterilization requirements for handpieces and accessories.
Introduces the console components section.
Illustrates and describes the main components of the console on its cart.
Details the components and functions found on the front of the console.
Details the components and functions found on the rear of the console.
Introduces the touchscreen display and its operational functions.
Describes the overall layout and the different screens available on the touchscreen.
Details the main screen layout and its control elements for system operation.
Explains the setup tasks screen for footswitch, handpiece, and cartridge configuration.
Describes the settings screen for language, system information, and usage hours.
Describes the online help screen for accessing information on system setup and operation.
Explains how the system indicates technical problems through alarms.
Details how to adjust amplitude, Tissue Select, aspiration, and irrigation control scales.
Explains the different modes for the footswitch and aspiration functions.
Introduces the components that make up the handpiece.
Lists and describes the physical parts of an assembled handpiece.
Details the structure, function, and use of the handpiece tip.
Describes the nosecone's role in securing the flue and its integrated O-rings.
Explains the flue's function as a sleeve for the tip and fluid delivery.
Lists and describes essential additional components for handpiece assembly.
Describes the sterile cartridge and tubing kit for irrigation and aspiration.
Explains the use of the single-use sterile torque wrench.
Describes the sterilizable torque base used for attaching/removing tips.
Introduces the procedures for assembling the system before its first use.
Provides step-by-step instructions for assembling the console onto the cart.
Details the procedure for connecting the power cord to the console and power source.
Outlines the steps for setting up the CUSA Clarity System in a sterile operating room environment.
Provides a concise checklist for setting up the system in the sterile field.
Guides the user through assembling the handpiece components in the sterile field.
Explains how to correctly attach the nosecone and flue to the handpiece.
Details the process of connecting the irrigation and aspiration tubing sets to the handpiece.
Introduces the procedures for setting up the CUSA Clarity System in the non-sterile environment.
Provides a quick checklist for setting up the system outside the sterile field.
Describes the process of assembling the handpiece in a non-sterile area.
Guides the user through setting up the console and powering on the system.
Explains how to connect the footswitch cable to the console.
Explains how to connect the handpiece cable to the console.
Details the steps for connecting the canister, cartridge, and contamination guard.
Introduces the procedures for operating the CUSA Clarity System during surgery.
Provides a quick reference guide for operating the CUSA Clarity system.
Describes how to verify all system connections are properly made.
Guides the user through the process of priming the system with irrigation fluid.
Explains how to test the handpiece to ensure proper operation before use.
Details the steps to initiate the handpiece testing procedure.
Explains how to interpret the results of the handpiece test.
Indicates when the system is fully set up and ready for surgical use.
Introduces procedures for changing tips while in the sterile field during surgery.
Provides a concise checklist for changing the surgical tip.
Details the steps for changing a surgical tip, including standby and removal.
Guides the user through attaching a new tip to the handpiece.
Introduces the procedures for disassembling, cleaning, and sterilizing the system components.
Provides a quick reference guide for disassembling the system.
Provides a quick reference guide for cleaning system components.
Details the procedures for disassembling the handpiece and console.
Guides the user through the process of disassembling the console.
Explains how to detach the contamination guard from the system.
Details the procedure for safely powering down the CUSA Clarity system.
Outlines the general procedures for cleaning the system components.
Provides instructions for cleaning the console's touchscreen display.
Details the cleaning process for the console and its accompanying cart.
Describes how to clean the handpiece, Extended Use Tips, and torque base.
Provides instructions for cleaning the system's footswitch.
Details the method for cleaning the sterilization tray.
Describes the overall process of sterilizing the CUSA Clarity system components.
Explains how to package the handpiece and components for steam sterilization.
Lists the specific temperature, time, and cycle parameters for sterilization.
Details the factors and procedures for steam sterilizing the handpiece and components.
Introduces the routine maintenance tasks for the CUSA Clarity system.
Provides a quick overview of routine maintenance tasks and their frequency.
Details handpiece maintenance schedules and when to return/replace it.
Provides guidelines for safely moving and transporting the CUSA Clarity system.
Describes recommended conditions for storing the system and its accessories.
Outlines the correct procedures for disposing of the CUSA Clarity system equipment.
Details the process for returning equipment to Integra for repair or service.
Explains how to obtain a Return Authorization Number before shipping equipment.
Lists replacement parts available from Integra and ordering information.
Provides contact information for Integra's service centers worldwide.
Introduces the troubleshooting procedures for the CUSA Clarity system.
Guides the user on how to extract log files for diagnostic purposes.
Lists and explains system alarms, their causes, and recommendations.
Details technical messages displayed by the system and their resolutions.
Provides guidance on troubleshooting issues related to amplitude settings and indicators.
Offers solutions for problems encountered with the aspiration function.
Provides solutions for issues related to the irrigation function.
Introduces the crucial safety information regarding MRI environments.
Warns and instructs on the system's incompatibility with MRI environments.
Lists the dimensions, weight, and cable length for the console.
Details specifications for various CUSA Clarity surgical tips, subsystems, and handpiece.
Lists voltage, frequency, power, fuses, and power cord details.
Specifies the system's duty cycle and operating/storage environmental conditions.
Lists the various international standards the CUSA Clarity system meets.
Outlines the system's classification according to regulatory bodies like FDA and EU.
Provides information regarding Electromagnetic Compatibility (EMC) of the system.
Offers guidance on electromagnetic emissions and the system's suitability for hospital environments.
Provides guidance on electromagnetic immunity and recommended environments.
Details RF immunity levels and recommended separation distances for communications equipment.
Outlines the terms, coverage period, and exclusions of the product warranty.
Describes Integra's policy for handling service, repairs, and equipment replacement.
Details which repair parts and services are covered under the warranty.
Defines customer responsibilities for quality control and limitations of liability.
