Chapter 7 Maintenance And Functional Testing; Overview; Routine Care And Maintenance; Handpiece Maintenance - Integra CUSA Clarity System Service And Maintenance Manual

Chapter 7 - Maintenance and Functional Testing

7.1 Overview

Annual 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 Maintenance

This 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.
Frequency
Daily or when used
Daily or when used
Every 6 months, or when filter changes color
After 50 hours of use, or 200 surgical
procedures, whichever comes first

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.
CUSA® Clarity System Service and Maintenance Manual
Equipment Task
Console Clean and wipe dry
Footswitch Clean the footswitch
Contamination Guard Replace the contamination guard. Write the installation date the guard
Handpiece Return handpiece to Integra Service and replace it with a new handpiece
Table 7-1
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