Integra LifeSciences Corporation
CUSA Clarity 36kHz Handpiece Ref C7036 Instructions for Use Rev C Nov 2016
Instructions for Use
84 Pages
Preview
Page 1
EN – ENGLISH Operating Temperature: +10oC to +35oC Transport and Storage Temperature: -20oC to +60oC
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Catalog Number
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Serial Number 3
2 MR Unsafe
Contents 1
Handpiece Cable with Connector
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Handpiece Connecting Body
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Handpiece Body
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Aspiration Port
CAUTION, Consult accompanying documents Keep Dry Operating Humidity: 30% to 85% Transport and Storage Humidity: 15% to 85%
Introduction
Waste Electrical and Electronic Equipment
The CUSA® Clarity handpiece is a hand-held surgical device with a tip that is applied to patient tissue during surgical procedures.
C7036
Description
Frequency
Handpiece
36kHz
This product is not made with natural rubber latex
WARNING No modification of this equipment is allowed.
Intended Use
WARNING
The CUSA Clarity handpiece is intended for use with the CUSA® Clarity Ultrasonic Surgical Aspirator System. Refer to the CUSA® Clarity Ultrasonic Surgical Aspirator System Operator’s Manual for indications, contraindications, and warnings.
When the handpiece is connected to a CUSA® Clarity System that is powered on, but the handpiece is not in use, keep the handpiece away from the patient. Place the handpiece on a sterile, flat, dry, nonconductive, and highly visible surface.
Intended Users
WARNING
The intended users of this Instructions for Use (IFU) and the equipment it describes are qualified medical professionals who are trained in the particular surgical technique and surgical procedure to be performed, and trained in the use of this equipment.
When the handpiece is powered on, contact of the tip with a hard surface (for example: a metal instrument, tray, staples, clips, instruments, and so on) may damage the tip of the handpiece.
WARNING
Symbols Used on Labeling
Do not use a damaged handpiece with the CUSA Clarity System. This may result in injury to the patient or user.
0123 Product complies with the
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requirements of directive 93/42/EEC CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician
WARNING Touching the tip of the handpiece by the user, while the handpiece is powered on, may result in personal injury.
Manufacturer
WARNING
Date of Manufacture
The minimum aspiration level setting is 10%. This ensures proper handpiece cooling and performance. Insufficient aspiration may cause premature handpiece or tip failures and may induce heat exchange with the patient or user, and cause tissue burns.
Follow Instructions for Use
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EN – ENGLISH
WARNING
Attaching a Tip
When testing the handpiece, do not allow the tip to come in contact with any person or object during tip activation. Contact may result in injury to the patient and/or user, or handpiece tip damage. Contact with anything may cause the test to fail.
1. Thread a tip onto the handpiece connecting body by turning the tip clockwise until it is finger tight.
WARNING Do not power up the handpiece without performing a prime cycle (that is, irrigation fluid must flow from the distal tip of the handpiece). Failure to prime the handpiece could result in permanent damage to the handpiece (internal and/or external components) and may induce heat exchange with the patient and/or user, and cause tissue burns.
Place the torque base on a flat surface or in the designated spot in the sterilization tray.
WARNING Before use, sterilize the torque base in the sterilization tray with the handpiece.
WARNING To ensure sterility, assemble sterile handpiece and tip in the sterile field only.
2. Place the handpiece on the torque base as shown and make sure that the 2 flat metal sides fit snugly in the metal slot at the end of the base.
Sterilization Information Supplied non-sterile. The handpiece must be sterilized before use. Steam sterilization only. Refer to the CUSA® Clarity Ultrasonic Surgical Aspirator System Operator’s Manual for the steam sterilization parameters.
3. Hold the handpiece in2the base and place the provided torque wrench (color side towards handpiece) over the tip.
MR Safety Information Refer to the CUSA® Clarity Ultrasonic Surgical Aspirator System Operator’s Manual for full MR safety information.
Disposal of the Equipment 3
The handpiece is considered electrical equipment and must be disposed of in accordance with regional regulation hospital protocols.
CAUTION To avoid product damage, always use the torque base to hold the handpiece while using the torque wrenchto tighten or loosen the tip. Avoid over torqueing the tip.
Duty Cycle Under maximum loading conditions, the CUSA® Clarity console is suitable for ultrasonics activation times of 10 minutes on, 5 minutes off.
4. Rotate the torque wrench clockwise until it clicks twice
Assembling the Handpiece in the Sterile Field
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NOTE: For information about changing tips in the sterile field, refer to the “Changing Tips in the Sterile Field During a Surgical Procedure” section CUSA® Clarity Ultrasonic Surgical Aspirator System Operator’s Manual.
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For this procedure, use the sterile, disposable torque wrench (C7602) and the sterilizable torque base (C7636).
NOTE: Keep the torque wrench and base in the sterile field in case you need to change a tip during the procedure.
WARNING The handpiece and handpiece accessories (tip, flue, stylet, and nosecone) must be sterile before surgical use. Before use, sterilize the torque base in the sterilizer tray with the handpiece.
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EN – ENGLISH
Attaching the CUSA Quick Connect™ Tubing
Attaching the Nosecone and the Flue 1. Slide the larger end of the nosecone over the tip and slide it down over the neck of the handpiece making sure the white dots are aligned.
1. Open the CUSA Quick Connect™ cartridge and tubing set using proper sterile technique.
5 2. Rotate the nosecone clockwise until it locks into place and the white dot on the nosecone aligns with the white dot on the body of the handpiece.
Make sure the white dots are aligned on the nosecone and handpiece.
2. Pick up the larger loop of the irrigation and aspiration tubing set to be brought into the sterile field and assembled to the handpiece.
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3. Slide the flue onto the nosecone base.
4. Make sure that the flue is aligned with the preaspiration holes near the tip.
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.
NOTE: If the aspiration holes are completely covered, most of the irrigation fluid may be aspirated back through the handpiece, impairing cavitation, thus reducing Surgical Aspirator efficacy.
4. Attach the aspiration tubing to the aspiration port at the base of the handpiece.
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EN – ENGLISH 5. Attach the irrigation tubing to the Luer lock fitting on the handpiece flue.
6. Push the irrigation tubing into the clip at the base of the handpiece.
7. Clip the handpiece cable to the aspiration tubing.
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8. Keep additional tubing and cable in the sterile field to allow you to reposition the console.
Patent Pending
Priming the System
Manufacturer
Once you have completed system setup, prime the irrigation system as described in the CUSA® Clarity Ultrasonic Surgical Aspirator System Operator’s Manual. Repeat priming until you see irrigation fluid at the handpiece tip.
Integra LifeSciences (Ireland) Limited IDA Business &Technology Park Sragh Tullamore County Offaly Ireland
Testing the Handpiece
USA & Canada: (800) 997-4868 Outside USA: (609) 936-5400
Once you have completed priming the system, test the handpiece to ensure that you have assembled the tip correctly. Refer to the CUSA® Clarity Ultrasonic Surgical Aspirator System Operator’s Manual for instructions on how to test the handpiece.
www.integralife.com Assembled in: USA
Disassembling, Cleaning, and Sterilizing
Integra, the Integra logo and CUSA are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. CUSA Quick Connect is a trademark of Integra LifeSciences Corporation or its subsidiaries. © 2016 Integra LifeSciences Corporation. All Rights Reserved. 92905282 Revision C 11/2016
For instructions on disassembling, cleaning, and sterilizing the handpiece, refer to the CUSA® Clarity Ultrasonic Surgical Aspirator System Operator’s Manual. 5
SV – SVENSKA
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SV – SVENSKA
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0123 0086 Patent Pending Manufacturer Integra LifeSciences (Ireland) Limited IDA Business &Technology Park Sragh Tullamore County Offaly Ireland USA & Canada: (800) 997-4868 Outside USA: (609) 936-5400 www.integralife.com Assembled in: USA
Integra, the Integra logo and CUSA are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. CUSA Quick Connect is a trademark of Integra LifeSciences Corporation or its subsidiaries. © 2016 Integra LifeSciences Corporation. All Rights Reserved. 92905282 Revision C 10/2016