Dyonics POWER II Footswitch Instruction for Use Rev B

English

Smith & Nephew DYONICS™ POWER II Footswitch Device Description The Smith & Nephew DYONICS POWER II Footswitch (REF 72201092) is a wired footswitch designed for use with the DYONICS POWER II Control Unit (REF 72200873) to control blade action. The footswitch communicates switch and pedal action to the control unit. The footswitch has three control pedals and two switches. The pedals control the forward, reverse, and oscillate modes. The buttons control the Lavage mode and Blade Window Lock functions. The footswitch can be operated in one of two modes: On/Off or Variable. On/Off will set the footswitch pedals to switch operation. Variable will set the footswitch pedals to adjust the handpiece speed based on pedal pressure.

Indications for Use The DYONICS POWER II Footswitch is intended as an accessory to the Smith & Nephew DYONICS POWER II Control System. The DYONICS POWER II Control System is indicated for use, when used with appropriate procedure specific blades, for resection of soft and osseous tissues including, but not limited to, use in large articular cavities, small articular cavities, and Functional Endoscopic Sinus Surgery (FESS). The FESS application is limited to those small blades which are appropriate for the procedure. The footswitch is required when using the following handpieces: ∫ Standard Shaver Handpiece (REF 7205355)

Warnings • It is the surgeon’s responsibility to be familiar with the appropriate surgical techniques prior to use of this device. • Read these instructions completely prior to use. • Read the Smith & Nephew DYONICS POWER II Control System Operations/Service Manual (REF 10600181) completely prior to use.

Precautions U.S. Federal law restricts this device to sale by or on the order of a physician. • In all cases, the judgment of the physician (in the best interest of the patient) may take precedence over the procedures described in this Instructions for Use. • Prior to each use, inspect the device to ensure it is functioning properly and not damaged. Do not use a damaged device. • Inspect all components regularly for wear. • To prevent damage to the control unit connector parts, do not plug in wet. Ensure that cleaned footswitch cable connectors are completely dry prior to connecting to the control unit.

Instructions for Use Connect the DYONICS POWER II Footswitch to the footswitch connector port located on the front panel of the DYONICS POWER II Control Unit. CAUTION: To prevent damage to the control unit connector parts, do not plug in wet. Ensure that cleaned footswitch cable connectors are completely dry prior to connecting to the control unit.

∫ UltraLight Shaver Handpiece (REF 7205971) ∫ POWERMAX™ Handpiece (REF 7210586) ∫ POWERMAX™ ELITE™ Handpiece (REF 72200617) ∫ Mini Shaver Handpiece (REF 7205357) The footswitch also may be used with hand control shaver handpieces.

Contraindications None known.



10600267 Rev. B

DYONICS™ POWER II Footswitch

Instructions for Use

English Note: The footswitch does not control the Forward or Reverse Speed Shift settings. The <> (oscillate) pedal causes the control unit to send alternate forward and reverse commands to the handpiece. The control unit continues the alternating signals until the foot is removed from the <> pedal.

DYONICS™ POWER II Footswitch

<> L

R

Blade Window Lock Blade Window Lock sets the stop position of the inner blade relative to the opening at the top of the outer blade. Press and hold the Window Lock button on the footswitch to rotate the blade. When the blade is in the best stopping position for the procedure, release the Window Lock button.

Figure 1: The DYONICS POWER II Footswitch

The DYONICS™ POWER II Footswitch has three control pedals and two switches. The pedals are labeled L, R, and <>. The L and R pedals default to reverse and forward, respectively. Depressing the left or right pedal causes the control unit to supply power to the handpiece to drive the blade in the direction indicated. The left and right pedals can be configured to run either forward or reverse. The center (<>) pedal is always oscillate. The two switches provide control for the Blade Window Lock function and the DYONICS 25 Fluid Management System’s Lavage function. The footswitch can be assigned to either Port A or Port B on the DYONICS Power II Control Unit. For more information, see the DYONICS POWER II Control System Operations/Service Manual (REF 10600181).

On/Off and Variable Modes

Lavage The DYONICS POWER II footswitch Lavage button works only with the DYONICS 25 Fluid Management System. In addition, the footswitch Lavage button will work only when: 1. The footswitch and DYONICS 25 control unit are assigned to the same port, and 2. The DYONICS POWER II Control Unit and DYONICS 25 control unit are connected to each other via the DYONICS 25 Shaver Interface Cable (REF 91000973). For information about the DYONICS POWER II Control Unit, read that product’s Operations/Service Manual (REF 10600181). For more information about the DYONICS 25 Fluid Management System, read that product’s Operations/Service Manual (REF 1061600).

The DYONICS POWER II Footswitch operates in either the On/Off or Variable mode.

Cleaning

On/Off will set the footswitch pedals to switch operation. Depressing the pedal causes the handpiece to operate at full set speed. Releasing the pedal turns the handpiece off.

Follow this procedure after each operation to clean the footswitch: 1. Disconnect the footswitch cable from the control unit.

Variable will set the footswitch pedals to adjust the handpiece speed based on pedal pressure, much like the gas pedal in a car. The Left, Right and Oscillate pedals each will vary set speed between 0-100%, depending upon the pressure applied to the pedal. Maximum pressure provides 100% of set speed. Zero pressure stops the device.

2. Wipe the footswitch and footswitch cable with a clean damp cloth (and mild germicide or isopropyl alcohol).

DYONICS™ POWER II Footswitch

Instructions for Use

3. Dry the cable connector completely before connecting to the control unit footswitch connector port.

10600267 Rev. B



English

Warning Message Table If a problem occurs with the footswitch, one of the following messages will appear on the LCD screen of the DYONICS™ POWER II Control Unit. Problem

Cause

Solution

Unknown Footswitch

Unable to communicate with footswitch. Try a different footswitch.

Check to make sure that the footswitch cable is properly connected to the front panel. Try another footswitch.

Footswitch Error

Check footswitch for depressed pedals or switches. If none present, try different footswitch.

Check to make sure that the footswitch cable is properly connected to the front panel. Try another footswitch.

Footswitch Required

Handpiece does not have hand controls and requires a footswitch.

Connect footswitch to the front panel. Ensure that footswitch is set to same port as handpiece.

Warranty

Service Replacement Program

Smith & Nephew products are guaranteed to be free from defects in material and workmanship for the warranty period for a particular product, beginning from date of invoice. Refer to the current Smith & Nephew Product Catalog or contact Smith & Nephew Customer Service for specific warranty information.

Smith & Nephew offers a 24-hour Service Replacement Program for its products to minimize downtime in your operating room. Our goal is to ship you a service replacement unit within 24 hours** of your call (during normal business hours). For a Return Authorization (RA) number or for additional information on this program, call Customer Service at +1-800-343-5717 in the U.S., or contact your authorized representative.

This limited warranty is restricted to repair or replacement by Smith & Nephew, at its option, of any product found to be defective during the warranty period. Damage inflicted to a product by the user that causes it to be unsuitable for refurbishment may result in additional charges, regardless of warranty status. All warranties apply to the original buyer only. In no event shall Smith & Nephew be liable for any anticipated profits, consequential damages or loss of time incurred by the buyer with the purchase or use of any product. NO OTHER WARRANTY, EXPRESSED OR IMPLIED, IS GIVEN.

Service Replacement Units Warranty Smith & Nephew service replacement units are warranted to be free from defects in material and workmanship for the warranty period for a particular product, beginning from date of invoice. Refer to the current Smith & Nephew Product Catalog or contact Smith & Nephew Customer Service for specific warranty information.

**24-hour shipment is not offered in all countries.

Repair Service Program For devices no longer under warranty, repairs can be made by Smith & Nephew or by an authorized agent. Non-warranty repairs will be made at the list price of replacement parts, plus labor. If requested, we will provide an estimate of repair cost and time required for the repair before any work is done. Repair items should be carefully disinfected, repackaged, marked with the Return Authorization (RA) number, and returned postpaid to the appropriate Smith & Nephew Service Center. Smith & Nephew Customer Service or your local authorized representative can provide shipping information.

For Further Information If further information on this product is needed, contact Smith & Nephew Customer Service at +1-800-343-5717 in the U.S., or your authorized Smith & Nephew representative.

All trademarks acknowledged.



10600267 Rev. B

DYONICS™ POWER II Footswitch

Instructions for Use