DYONICS Power Shaver System Operation-Service Manual Rev G

Glossary of Symbols CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician.

Bidirectional Port.

EQUIPMENT CLASSIFICATION-

CAUTION: See Instructions for Use

Type B Equipment

ON

SUCTION ON

Main electrical power on.

Fluid flow through handpiece unrestricted.

OFF

SUCTION OFF

Main electrical power off.

Fluid flow through handpiece blocked.

SLOWER

CATALOG NUMBER

Decrease shaver speed.

Part number or reorder number.

FASTER

!

Increase shaver speed.

>> HANDPIECE

DIAGNOSTIC DISPLAY BUTTON Displays diagnostic codes.

FORWARD Clockwise direction of shaver rotation (distal view).

Shaver motor drive unit.

<<

REVERSE

<>

OSCILLATE

><

BLADE WINDOW LOCK

IPX8

Watertight equipment per IEC 529.

FOOTSWITCH

Counterclockwise direction of shaver rotation (distal view).

Foot pedal control.

MINIMUM

Alternating forward/reverse direction of shaver rotation.

Lowest shaver speed value.

MAXIMUM

Adjustment of cutting window stop position.

Highest shaver speed value.

SPEED Shaver rotation rate in revolutions per minute.

Smith & Nephew DYONICS™ Power Shaver System Operations/Service Manual

Non-ionizing electromagnetic radiation.

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Preface / Table of Contents

Preface This manual provides the information you need to operate and maintain both the basic and HERMES-Ready… Smith & Nephew DYONICS™ Power Shaver Systems. It is essential that you read and understand all the information in this manual before using or maintaining these systems. Information that pertains only to the Smith & Nephew DYONICS Power HERMES-Ready Shaver System (REF 7209912) is included where applicable.

Table of Contents Glossary of Symbols...1 Introduction...3–4 HERMES-Ready System Information . . .4 Indications...4

Maintenance...21 Electrical Interference...21 Environmental Protection...21 Preventative Maintenance...21

System Components...7–12 Control Unit Front Panel...7 Display and Control Switches...8 Blade Family Recall...9 Power Switch...9 Front Panel Connectors...9 Control Unit Rear Panel...10 Handpieces...11–12 Footswitch...12 Powered Instrumentation...12

Service...21–25 Service Philosophy...21 Front Panel Connectors...22 Replace Front Panel...22 Handpiece Cables...22 Replace Handpiece Cables...22 Control Unit Fuses...23 Electrical Safety Checks...24 Dielectric Strength Test...24 Ground Test...24 Leakage Current Test 115 VAC with Power On...25 Leakage Current Test 230 VAC with Power On...25

Setup

...13

Troubleshooting...26 – 27

Operation...14-17 Precautions...14 Blade Motor Control...14 Suction Control...14 Blade Selection...15 Blade Installation...16 Blade Window Lock...17 Blade Speed...17 Forward...17 Reverse...17 Oscillate...17

Technical Specifications...28–29

Contraindications...4 Warnings...5 Precautions...6

Recommended System Configuration...18–19 Cleaning and Sterilizatiion...20

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Guidance and Manufacturer’s Declaration - Electromagnetic Emissions...30 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity...31–32 Guidance for Separation Distances...33 Warranties...Back Cover Service Replacement Program...Back Cover

Figures 1a HERMES-Ready Control Unit Front Panel...7 1b Control Unit Front Panel...7 2 Blade Direction - Forward...8 3 Blade Direction - Reverse...8 4 Blade Direction - Oscillate...8 5a HERMES-Ready Control Unit Rear Panel...10 5b Control Unit Rear Panel...10 6 Footswitch...12 7 Standard Suction Lever...14 8 POWERMAX Suction Lever...14 9 Mini Motor Suction Lever...14 10 Cutting Efficiency with Soft Tissue...15 11 Cutting Efficiency with Osseous Tissue...15 12 Key Slot (A) and Key (B)...16 13 IEC 60601-1-1 System Configuration Basic System...18 14 IEC 60601-1-1 System Configuration HERMES-Ready System...19 15 Diagnostic Code Display...26 Tables 1 Programmed Blade Speeds...15 2 115 VAC 60 Hz Leakage Current Test...30 3 230 VAC 50/60 Hz Leakage Current Test...30 4 DYONICS Diagnostic Codes...27

Repair Service Program...Back Cover

Smith & Nephew DYONICS™ Power Shaver System Operations/Service Manual

Introduction

The Smith & Nephew DYONICS™ Power Shaver System is a highly versatile surgical tool designed to meet the most demanding requirements of abrasion arthroplasty, synovectomy, and intra-articular cutting and shaving. A variety of disposable straight and curved surgical blades and burrs can be inserted into the shaver handpiece for various surgical requirements. Using the footswitch, you control blade action, selecting forward, reverse or oscillate. The control unit allows you to set the blade speed within minimum and maximum speeds preprogrammed for each blade type. The optional Hand Control Shaver Handpiece allows the surgeon to control shaver operation without the need for a footswitch. The optional Mini-Shaver Handpiece accepts a special selection of blades designed for small-joint procedures, and for Functional Endoscopic Sinus Surgery (FESS).

Note: The Smith & Nephew POWERMAX™ Shaver Handpiece (REF 7210542) allows for shaver blades to be inserted with the blade window aligned to the suction control lever or 180° opposite the lever.

Note: Blade types are not recognized by the POWERMAX Shaver Handpiece (REF 7210542) when blades are inserted with the blade window aligned to the suction control lever.

Note: The Smith & Nephew Ultra Series curved blades and the Ultra Series TURBOWHISKER™ blade may be used in all Smith & Nephew shaver handpieces. Standard curved blades and the standard TURBOWHISKER blade will not fit Smith & Nephew DYONICS UltraLight Handpieces. The Smith & Nephew DYONICS Power Shaver System features many performance and easeof-use advantages, including: • Intuitive front panel display and controls provide an immediate understanding and control of system performance.

Smith & Nephew DYONICS™ Power Shaver System Operations/Service Manual

• The system automatically detects the blade type in use and sets the operating parameters accordingly. • When you change blades, Blade Family Recall automatically returns to the previous speed settings in Forward/Reverse and Oscillate modes (blade types are not recognized by the UltraLight Handpiece).

Note: Blade types are not recognized by the POWERMAX Shaver Handpiece (REF 7210542) when blades are inserted with the blade window aligned to the suction control lever. • Speed Shift offers the ability to alternate between user-defined, preset low and high speeds by simply depressing and holding the reverse or forward buttons on the handpiece, respectively (Hand Control Shaver Handpieces REF 7205354, REF 7209891 and REF 7210542). • The low profile footswitch enables more comfortable control of the system over a sustained period. • Blade Window Lock, which can be set from the control unit, footswitch or hand control shaver handpieces, determines the stop position of the inner blade relative to the opening in the outer blade. • Optional HERMES® Digital O.R. Control Center voice command and/or touch screen control. • The optional Hand Control Shaver Handpieces (REF 7205354, REF 7209891 and REF 7210542) features push button controls that can be used instead of the footswitch controls. • A latch button on the blade collar ejects the blade for faster, easier blade changes. • A suction lever mounted on the handpiece, which operates from fully opened to fully closed, allows manual control over outflow. • Front panel connectors for the footswitch and the handpiece are field replaceable.

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Introduction (continued) / Indications / Contraindications

HERMES-Ready… System Information

Contraindications

The Smith & Nephew DYONICS™ Power HERMESReady… Shaver System is configured to be connected to the HERMES® Digital O.R. Control Center via the HERMES port, which uses an RS-232 serial communications protocol. When connected, the system functions may be accessed by direct voice commands or by manual use of a touch screen control. It is recommended that the physician and support personnel are thoroughly familiar with the setup and operation of the HERMES Digital O.R. Control Center. Please refer to the HERMES Digital O.R. Control Center Operating and Maintenance Manual for the proper setup, use, and troubleshooting of the Voice Control Interface portion of that device. When the HERMES Digital O.R. Control Center is connected and active, the function parameters of the Smith & Nephew DYONICS Power HERMES-Ready Shaver System may alternatively be adjusted using the buttons on the front panel. For troubleshooting or further information, please refer to your HERMES Digital O.R. Control Center Operating and Maintenance Manual.

Smith & Nephew DYONICS shavers and blades should not be used with patients exhibiting ankylosis, without adequate joint space or distention for arthroscopic inspection. Abrasion arthroplasty may not be effective in treating heavy patients or those with ankylosis, instability or expectations beyond the relief of pain. Varus or valgus deformity is not of itself a contraindication in patients with a good range of motion and without gross instability or extreme malalignment (15° varus, 30° valgus). Intracortical abrasion arthroplasty may be contraindicated in patients who do not qualify for high tibial osteotomy or total knee replacement. Synovectomy is contraindicated when the disease has progressed beyond the phase of synovial proliferation, and advanced rheumatoid arthritis when erosion of the articular cartilage is present. The 2.0 mm and 2.9 mm TURBOWHISKER™ and 2.9 mm Cutter are contraindicated for the FESS application.

Indications The Smith & Nephew DYONICS Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities, and for Functional Endoscopic Sinus Surgery (FESS). The FESS application is limited to those small blades (2.0 mm to 3.5 mm) which are appropriate for the procedure.

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Smith & Nephew DYONICS™ Power Shaver System Operations/Service Manual

Warnings

Please read this manual before using the Smith & Nephew DYONICS™ Power Shaver System. The brief operating instructions in this guide will make the system easier to use, while the recommended maintenance procedures will ensure optimal performance over years of reliable use. Of course, as with any surgical instrument, there are important health and safety considerations. These are listed below and highlighted within the text. Upon turning the control unit to ON, and when no handpieces are plugged into channel A or B, the current software version is displayed on the front panel display window.

Warnings • Only Smith & Nephew DYONICS Disposable Arthroscopic Surgery Blades can be used with the Smith & Nephew DYONICS Power Shaver System. The blades are intended for single use only. Do not resterilize. Do not lubricate blades. Discard the blades after use. • Before using the shaver system for the first time, you should review all available product information. You should be experienced in arthroscopic surgery with powered instruments. Healthy articular soft tissue and cartilage can be injured by the blades. Use every available means to avoid such injury. • DANGER: Risk of explosion if used in the presence of flammable anesthetics. • DYONICS Disposable Arthroscopic Surgery Blades are packaged as a set. They must be used as supplied. Do not interchange blade components. • Irreversible damage will result from any attempt to disassemble curved blades.

• Periodic irrigation of the tip of the burr or cutter is recommended to provide adequate cooling of the blade and to prevent accumulation of excised materials in the surgical site. Ensure that suction of 128 mmHg minimum is flowing while the instrument is running. • HIGH VOLTAGE (1500 VAC) is present during dielectric strength testing. Exercise extreme caution while operating the Dielectric Strength Tester to prevent personal injury from electrical shock, or damage to the equipment. Ensure that only authorized personnel are in the test area during the tests, and that the cover is on the DYONICS Power Control Unit before beginning the tests. • Dangerous voltages are present during Leakage Current Testing. DO NOT TOUCH the control unit while power is applied. • If this unit is configured as part of a system, the entire system should be tested for compliance with IEC 60601-1-1. • If the leakage current of the configured system exceeds the limits of IEC 60601-1-1, install an appropriately rated UL 2601-1/ IEC 60601-1 approved isolation transformer and retest the system. • The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include: – Use of the accessory in the patient vicinity. – Evidence that the safety certification of the accessory has been performed in accordance with UL 2601-1/IEC 60601-1 and/or IEC 60601-1-1.

• Irreversible damage to burrs will result if they are run without the flow of irrigation (dry).

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Precautions

Precautions U.S. Federal law restricts this device to sale by or on the order of a physician. • Use of shaver blades, saw blades, burrs or accessories from a manufacturer or supplier other than Smith & Nephew or its authorized representatives may permanently damage, impede performance, or cause failure of your Smith & Nephew DYONICS™ Power Shaver System. Any such use will render any and all Smith & Nephew warranties null and void. • Use of reprocessed, single-use shaver blades may permanently damage, impede performance, or cause failure of your DYONICS Power Shaver System. Use of such products may render any warranties null and void. • Do not allow the rotating portion of any blade or burr to touch any metallic object such as a cannula or arthroscope. Damage to both instruments is likely. Damage to the blade can range from a slight distortion or dulling of the blade edge to actual fracture of the tip in vivo. If such contact does occur, inspect the tip. If you find cracks, fractures or dulling, or if you have any other reason to suspect a blade is damaged, replace it immediately.

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• Do not sterilize or immerse the Smith & Nephew DYONICS Power Control Unit in disinfectant. • Do not cool the handpiece by immersing it in cold water. • Do not connect any equipment to the serial port unless it was designed by Smith & Nephew to communicate with the shaver system control unit via this port. • Electrical safety testing should be performed by a biomedical engineer or other qualified person. • This equipment is designed and tested to minimize interference with other electrical equipment. However, if interference occurs with other equipment it may be corrected by one or more of the following measures: – Reorient or relocate this equipment, the other equipment, or both. – Increase the separation between the pieces of equipment. – Connect the pieces of equipment into different outlets or circuits. – Consult a biomedical engineer.

• Do not operate the handpiece in the open air for an extended period, as the lack of irrigation may cause the blade to overheat and seize.

• This equipment contains electronic printed circuit assemblies. At the end of the useful life of the equipment it should be disposed of in accordance with any applicable national or institutional related policy relating to obsolete electronic equipment.

• Excessive side-loading on the blade does not improve cutting performance and, in extreme cases, may result in wear and degradation of the inner assembly.

• The optional HERMES® Bidirectional Port is not a USB protocol-supported connection. Only connect the shaver system to a HERMES Digital O.R. Control Center.

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Smith & Nephew DYONICS™ Power Shaver System Operations/Service Manual

System Components

The Smith & Nephew DYONICS™ Power Shaver System consists of a variety of components: • The shaver system control unit provides for variable speed operation of the cutting tools, and displays user prompts and system diagnostic codes. • The shaver footswitch allows you to select Forward or Reverse blade rotation, or Oscillate mode in which the blade alternates between Forward and Reverse rotation. The low profile footswitch can also be used to set Blade Window Lock. • The shaver handpiece drives a variety of disposable surgical blades and provides manual control of suction flow. The optional Hand Control Shaver Handpiece features push-button controls for blade operation. The Mini Shaver Handpiece uses smaller blades for small-joint surgery and FESS applications.

• The optional HERMES® Digital O.R. Control Center allows alternative control of Speed up and Speed down, Blade Window Lock, and Port A or Port B selection. • The shaver system control unit can also drive high powered arthroscopic instruments (i.e., drills, wire/pin drivers, sagittal saws), purchased separately.

Control Unit Front Panel The control unit front panel includes system Speed Switches, Alphanumeric Display Window, Power Switch, Diagnostic Display Button, Diagnostic Indicator Light, Footswitch and Handpiece connectors (Figures 1a and 1b).

Figure 1a. Smith & Nephew DYONICS™ Power HERMES-Ready… Control Unit Front Panel

Figure 1b. Smith & Nephew DYONICS™ Power Control Unit Front Panel

Smith & Nephew DYONICS™ Power Shaver System Operations/Service Manual

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System Components (continued)

Display and Control Switches The control unit displays Minimum, Maximum and Set speeds, blade direction (Forward, Reverse, or Oscillate) and diagnostic codes. On the first line of the display, Forward (>>) and Reverse (<<) arrows indicate the blade direction. A horizontal bar graph in between the direction symbols indicates the speed of the blade relative to the range for the blade type. On the second line, from left to right, the shaver system displays minimum speed, the currently set speed, and the maximum speed. The shaver system senses the type of blade installed in the connected handpiece and sets the minimum and maximum speeds accordingly (blade types are not recognized by the UltraLight Handpiece). Set the actual blade speed using the Slower and Faster push buttons below the display.

Note: Blade types are not recognized by the Smith & Nephew POWERMAX™ Shaver Handpiece (REF 7210542) when blades are inserted with the blade window aligned to the suction control lever. Figures 2, 3 and 4 provide examples of how the screen displays speed and direction.

>> ||||||||||||||||||

>>

2700

5000

100

<< ||||||||||||||||||||||||| << 100

4500

5 000

Figure 3. Reverse Rotation

The blade is rotating in Reverse (<<) at its set speed of 4500 rpm. The minimum and maximum speeds for the blade in use are 100 rpm and 5000 rpm, respectively.

< > ||||||||||| 100

<2000>

<> 5000

Figure 4. Oscillate Mode

The blade is oscillating (<>) between 2000 rpm Forward and 2000 rpm Reverse. The blade rotates in one direction until it reaches the set speed. It then stops, changes direction and accelerates to the set speed, at which point it will stop and reverse direction again.

Figure 2. Forward Rotation

The (>>) symbols show the blade direction is Forward (rotating clockwise), while the bar graph indicates the blade is rotating at 2700 rpm. The minimum and maximum speeds for the blade in use are 100 rpm and 5000 rpm, respectively.

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Smith & Nephew DYONICS™ Power Shaver System Operations/Service Manual

System Components (continued)

Blade Family Recall

Power Switch

Note: Blade types are not recognized by the

The rocker switch on the right side is the power ON/OFF switch for the entire system. The switch is illuminated when the system is ON.

Smith & Nephew POWERMAX™ Shaver Handpiece (REF 7210542) when blades are inserted with the blade window aligned to the suction control lever.

Note: Blade types are not recognized by the UltraLight Handpiece. Blade Family Recall ensures that the last settings (Forward, Reverse, and Oscillate modes) for a blade “family” (i.e., straight, curved, and burrs) become the default the next time that family of blades is used, even after the unit is turned OFF. • Mode: The last mode of operation (Forward, Reverse, and Oscillate) for each family is also remembered. • Reset: The factory defaults may be reset by depressing and holding the Diagnostic Display Button ( ! ) on the front panel while, at the same time, turning the power ON.

Note: If system is turned off for any reason, wait at least 15 seconds before turning power back on.

Front Panel Connectors There are three connectors on the front panel: Footswitch on the left, and two Handpiece connectors on the right. The buttons above each handpiece connector (marked A and B) allow selection of the handpiece connected to that channel. When a channel is selected the light above the connector is on.

When the shaver system detects a condition that requires attention, an indicator light on the front panel is illuminated. When the Diagnostic Display Button ( ! ) located below the red indicator light is pressed, the system displays one or more diagnostic codes. A slide-out diagnostic tray below the control unit front panel provides detailed information about diagnostic codes. (See “Troubleshooting” for additional information.) Green indicator lights located above the footswitch and handpiece connectors flash to indicate a condition pertinent to the affected connector. The speed selection buttons are directly below the display, Slower on the left and Faster on the right. Press these buttons to increase or decrease the most recently set speed within the minimum and maximum speeds for the blade type.

Smith & Nephew DYONICS™ Power Shaver System Operations/Service Manual

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System Components (continued)

Control Unit Rear Panel There are two connectors and a ground terminal on the rear panel (Figures 5a and 5b): • The 3-prong electrical connector allows connection of the shaver system to any 100–120/200–240 VAC, 50/60 Hz, 350 VA source using the power cord supplied with the system. The shaver system power supply automatically detects the local power standard and adapts the shaver system to that standard. • The 25-pin serial connector links the shaver system to other Smith & Nephew equipment such as the Smith & Nephew INTELIJET™ Fluid Management System and the On Screen Display Module. Information on making this connection is contained in the manual for the specific equipment.

• The Equipotential Compensator Terminal permits connection of the shaver system control unit to an external earthing system. • The optional HERMES® Bidirectional Port allows connection to a HERMES Digital O.R. Control Center. When connected, the following shaver functions can be controlled by voice and/or Pendant commands. - Speed up and Speed down - Blade Window Lock - Port selection, A or B Caution: Do not connect any equipment to the serial port unless it was designed by Smith & Nephew to communicate with the shaver system control unit via this port. Caution: The optional HERMES Bidirectional Port is not a USB protocol-supported connection. Only connect the shaver system to a HERMES Digital O.R. Control Center.

Figure 5a. Smith & Nephew DYONICS™ Power HERMES-Ready… Control Unit Rear Panel

RS-232C

Figure 5b. Smith & Nephew DYONICS™ Power Control Unit Rear Panel

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Smith & Nephew DYONICS™ Power Shaver System Operations/Service Manual

System Components (continued)

Handpieces A variety of shaver handpieces can be used with the Smith & Nephew DYONICS™ Power Shaver System Control Unit. The Standard Shaver Handpiece (REF 7205355) is a hand-held motor drive which is electrically connected to the control unit via a 10-foot (3-meter) cable and activated by a footswitch. The handpiece runs a variety of DYONICS disposable surgical blades. The handpiece is designed to sense the blade type installed and communicate that information to the control unit, which sets the operating parameters appropriate for the blade. The Hand Control Shaver Handpieces (REF 7205354, REF 7209891, and REF 7210542) features push-button controls for Forward, Reverse and Oscillate on the distal end of the handpiece. With these models you can control blade action with the handpiece as well as with the footswitch. The UltraLight Shaver Handpiece (REF 7205971) is designed for optimum weight reduction and does not sense blade type. All blades will run to a maximum of 5000 rpm in Forward and Reverse mode and 3000 rpm in Oscillate mode. The Smith & Nephew Ultra Series Curved Blades and the Ultra Series TURBOWHISKER™ blade are required for curved blade applications using the UltraLight Handpiece. Standard curved blades and the standard TURBOWHISKER blade will not operate in the UltraLight Handpiece. Footswitch operation when using the UltraLight Handpiece is the same as with the Standard Shaver Handpiece. The Mini Shaver Handpiece (REF 7205357) activated by a footswitch, is designed for arthroscopic procedures on small joints and for FESS applications. This handpiece runs small blades between 100 rpm and 3500 rpm.

Smith & Nephew DYONICS™ Power Shaver System Operations/Service Manual

All handpieces can be connected to either the A channel or B channel connector on the control unit front panel. The control unit automatically detects the type of handpiece connected. When a non-hand-control shaver is selected, the system prompts you to connect the footswitch by blinking the indicator light above the footswitch connector. Each handpiece model and its cable are autoclavable (see “Cleaning and Sterilization”). The handpiece cable is field replaceable on all handpieces with the exception of the Smith & Nephew DYONICS™ POWERMAX™ Shaver Handpieces which must be returned to Smith & Nephew for replacement (see “Maintenance”). Set speeds are remembered for Forward/ Reverse and Oscillate modes independently and in increments of 100 rpms. Suction is connected to a portal on the proximal end of the handpiece and removes fluid and debris drawn through the blade window. In addition to removing fluids, the suction cools and lubricates the motor drive. A lever on the distal end of the handpiece provides suction flow control. The lever can be adjusted from fully opened to fully closed to provide immediate manual control of the suction rate. Cutting takes place when the blade edge rotates across the blade’s outer window. The blade action alternately opens and closes the window to the suction flow. With the Blade Window Lock feature, you can set the handpiece to stop the blade in a specific position. The window can be fully opened or closed, or somewhere in between, depending on what is required for the technique. Caution: Do not operate the handpiece in the open air for an extended period, as the lack of irrigation may cause the blade to overheat and seize.

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System Components (continued)

Forward/Reverse Speed Shift Depressing and holding the Forward or Reverse buttons on the handpiece for one second will alternately shift between two pre-set speeds (high and low) in the forward or reverse direction. High and low speeds are set by pushing the Slower or Faster buttons on the front panel of the Smith & Nephew DYONICS™ Power System Control Unit in either the slow or fast speed. If the slow and fast speeds are not set, then depressing and holding the handpiece buttons will not activate Speed Shift.

Note: Speed Shift is not applicable in Oscillate mode and does not work through any footswitch.

Footswitch The footswitch is required when using the Standard Shaver handpiece, the UltraLight Shaver Handpiece, or the Mini Shaver Handpiece, and can be optionally used with the Hand Control Shaver Handpieces. The shaver system uses a standard low profile footswitch (REF 7205399) to control blade action (Figure 6). The footswitch, which plugs into the connector on the left side of the control unit front panel, has three circular buttons (REVERSE, OSCILLATE and FORWARD) and a smaller button for blade WINDOW LOCK.

Note: The footswitch does not control the Forward or Reverse Shift Speed settings. The OSCILLATE button causes the control unit to send alternate forward and reverse commands to the handpiece. The control unit reverses direction when the blade rotation reaches the set speed. The control unit continues the alternating signals until you remove your foot from the pedal.

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. Each time you press the WINDOW LOCK button, the blade rotates clockwise to a new stop position. Blade WINDOW LOCK can also be set by simultaneously pressing the Slower and Faster buttons on the shaver control unit, or by pressing and holding the Oscillate button on the Hand Control Shaver Handpieces. Two optional footswitch models are available for use with the shaver system: • The Accelerator Footswitch (REF 7205397) allows the Forward, Reverse and Oscillate buttons to control speed as well as blade direction. • The Pedal Style Footswitch (REF 7205396) features two foot pedals to control blade action.

Powered Instrumentation

Figure 6. Smith & Nephew DYONICS™ Power System Footswitch

Depressing the FORWARD or REVERSE button causes the control unit to supply power to the handpiece to drive the blade in the direction indicated. The control unit accelerates the blade rotation until it reaches the set speed and maintains that speed until you release the button. The footswitch buttons are not throttles, but simply turn the motor drive ON or OFF in a specific direction. 12

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The Smith & Nephew DYONICS Power Shaver System provides the convenient capability to drive powered instrumentation (i.e., drill/wire drivers, sagittal saw, etc.) as well as a selection of associated blades and drill bits when purchased separately. If these items have been purchased, please read the Instruction Manual for the Smith & Nepehw DYONICS Power System Pistol Grip and Inline Sagittal Saw prior to using this equipment. If you did not receive this manual, please contact Smith & Nephew Customer Service at 1-800-343-5717 and request a manual (REF 1060787).

Smith & Nephew DYONICS™ Power Shaver System Operations/Service Manual

Setup

Setting up the Shaver System for use in a Surgical Procedure Warning: – Danger: Risk of explosion if used in the presence of flammable anesthetics. 1. Place the control unit on the instrument cart and plug the unit power cord into the rear panel connector and a grounded AC power source. The control unit power supply automatically detects the local power standard and sets the unit to convert the supplied voltage. 2. Push the power switch to the ON ( | ) position. The control unit performs a status check and then displays a welcome message including the software version. The footswitch and handpiece connector lights blink, prompting connection of the system components. 3. Connect the shaver handpiece cable to the channel A or channel B front panel socket. Push-on: The shaver handpiece cable connector has a locking sleeve which holds a protective cap. Pull the sleeve back to remove the cap. Orient the handpiece cable plug by aligning the red dots on the plug and the panel. Push the plug into the socket and release the locking sleeve. The handpiece cable is fully engaged when the red dots are almost touching. Twist-on: Unscrew protective cap. Orient the handpiece cable plug by aligning the red dots on the plug and the panel. The handpiece cable is fully engaged when the red dots are almost touching.

Smith & Nephew DYONICS™ Power Shaver System Operations/Service Manual

The system automatically selects channel A upon power up. If a handpiece is connected to channel B, you must press the channel B button to select it. If handpieces are connected to both channels, press the channel A or channel B button to select a handpiece. If the connected handpiece is the Hand Control Shaver Handpiece, the footswitch indicator light stops blinking. However, you can still connect the footswitch and control the shaver by foot. 4. Plug the footswitch cable into the connector on the left side of the control unit front panel using the same insertion method as the handpiece connection. 5. Check the control unit display. When there is no blade in the connected handpiece, the control unit displays the speed range for a standard straight blade (100 rpm to 5000 rpm). The default set speed is 2000 rpm and the directional arrows indicate that the handpiece motor is stopped (><). 6. Press the Forward button on the footswitch to confirm shaver operation. The control unit bar graph will show the motor accelerating to 2000 rpm, while the directional arrows will indicate forward rotation (>>). The handpiece motor action can be observed by looking inside the distal end of the handpiece. 7. Verify Reverse and Oscillate modes. 8. Connect the suction by sliding the suction tubing onto the outflow portal on the proximal end of the handpiece.

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Operation

Warning: Before using the shaver system for the first time, you should review all available product information. You should be experienced in arthroscopic surgery with powered instruments. Healthy articular soft tissue and cartilage can be injured by the blades. Use every available means to avoid such injury.

Standard Shaver Handpiece

1. Verify that the handpiece and its cable are sterile. 2. Check to ensure that the blades and burrs required for the procedure are available. Warning: Only Smith & Nephew DYONICS Disposable Arthroscopic Surgery Blades can be used with the Smith & Nephew DYONICS™ Power Shaver System. The blades are intended for single use only. Do not resterilize. Do not lubricate blades. Discard the blades after use.

Figure 7. Suction Lever on the Standard Shaver Handpiece

1. Push the lever toward the blade to increase outflow. 2. Move the lever away from the blade to decrease outflow.

POWERMAX™ Shaver Handpiece

Blade Motor Control The button controls on the footswitch allow selection of three cutting actions: Forward (clockwise rotation), Reverse and Oscillate. With the standard Low Profile Footswitch (REF 7205399), the blade rotates in the direction specified, accelerates to the set speed and continues until you release the footswitch button. With the Accelerator Footswitch (REF 7205397), the blade accelerates in the selected direction until it reaches set speed for the blade type. Speed can be decreased and then increased by varying foot pressure. To activate the Hand Control Shaver Handpiece (REF 7205354, REF 7209891 and REF 7210542), press and release the Forward, Reverse or Oscillate button. The blade will operate in the selected mode until any button is pressed, which will stop the motor. Press another button to restart or change direction.

Suction Control The shaver handpiece has a suction flow control lever on the distal end of the handpiece which enables manual control outflow (Figure 7). The lever can be set anywhere between fully open and fully closed positions.

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Figure 8. Suction Lever on the POWERMAX™ Shaver Handpiece

1. Push the lever toward the blade to increase outflow. 2. Move the lever away from the blade to decrease outflow.

Mini Shaver Handpiece

Figure 9. Suction Lever on the Mini Shaver Handpiece

The lever on the Mini Shaver Handpiece rotates to the left and the right (Figure 9). 1. For maximum flow, position the lever so that it is in line with the handpiece. 2. To reduce flow, rotate the lever away from the center position.

Smith & Nephew DYONICS™ Power Shaver System Operations/Service Manual

Operation (continued)

Cutting MediumSynovial Tissue

• Smith & Nephew DYONICS™ Disposable Arthroscopic Surgery Blades are packaged as a set. They must be used as supplied. Do not interchange blade components. • Irreversible damage will result from any attempt to disassemble curved blades. • Irreversible damage to burrs will result if they are run without the flow of irrigation (dry).

TISSUE CUTTING RATE

Warnings

Os

cill

ate

Forward

BLADE SPEED

Figure 10. Cutting Efficiency with Soft Tissue

Blade Selection All Smith & Nephew DYONICS Disposable Arthroscopic Surgery Blades have been extensively tested for safety and performance. Based on these tests, shaver blade speed ranges have been preset in the control unit (Table 1). Tissue cutting performance has been determined at various speeds for each blade. This information indicates that Oscillate mode is more efficient for cutting soft tissue (Figure 10), while Forward mode is more efficient for cutting hard, osseous tissue (Figure 11).

TISSUE CUTTING RATE

Cutting MediumBovine Bone

ard Forw

Osc

e illat

BLADE SPEED

Figure 11. Cutting Efficiency with Osseous Tissue

Note: All blade speeds increase in increments of 100 rpm in Forward/Reverse mode. Table 1. Programmed Blade Speeds Blade Type Straight Blades Curved Blades Ultra Series Curved Blades Burrs and Series 3000 Blades Mini Blades

Default Set Speed

v3.0 Minimum

2000 2000 2000 2000 2000 2000 4000 2000 2000 1000

100 500 100 500 100 500 500 500 100 500

Maximum

Blade Direction

5000 * 3000 3000 3000 5000 3000 8000 †

Forward/Reverse Oscillate Forward/Reverse Oscillate Forward/Reverse Oscillate Forward/Reverse Oscillate Forward/Reverse Oscillate

3000 3500 3000

* Excluding Smith & Nephew TURBOWHISKER™ Blades (REF 7205316) which run to a maximum of 3000 rpm. † Excluding Smith & Nephew HELICUT™ Blades (REF 7205727), which run to a maximum of 5000 rpm. Smith & Nephew DYONICS™ Power Shaver System Operations/Service Manual

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Operation (continued)

When no blade is installed in the selected shaver handpiece, the control unit displays the default speed range and set speeds for straight blades.

Installing a Blade in the Shaver Handpiece 1. Remove the blade from the sterile package and insert the collar into the handpiece.

Note: The Smith & Nephew POWERMAX™ Shaver Handpiece (REF 7210542) allows for shaver blades to be inserted with the blade window aligned to the suction control lever or 180° opposite the lever. To insert a blade, orient the handpiece so that you can see the key slot (A) on the handpiece and the key (B) on the blade (Figure 12). Insert the blade into the handpiece so that the key goes into the slot. The key should be pushed in proximally as far as possible for a positive lock. Note that the cutting aperture is aligned 180° opposite the ridge on the handpiece. This feature allows for tactile orientation of the handpiece. A

B

The Mini Shaver has a locking sleeve on the blade end of the handpiece. The Mini Motor Blades have four ridges that key the blade to one of four positions, that is, the blade window faces up, down, right or left relative to the handpiece. Pull the locking sleeve back, insert the blade and release the sleeve when the blade clicks into position.

Note: Blade types are not recognized by the POWERMAX Shaver Handpiece (REF 7210542) when blades are inserted with the blade window aligned to the suction control lever. The system automatically detects the blade type (blade types are not recognized by the UltraLight Handpiece) and displays the appropriate speeds (Table 1). The blade is properly engaged when the control units displays the minimum and maximum speeds. 2. Press the Forward button and observe the blade action to verify that it is properly installed. The first time a blade type is installed in the handpiece during a procedure, the system sets the blade speed to a default value. Speed can then be increased or decreased when the blade types are changed during the procedure. The system recalls the speed last set for the blade type (this feature does not function when using the UltraLight Handpiece).

Note: Blade types are not recognized by the Figure 12. Key Slot (A) and Key (B)

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POWERMAX Shaver Handpiece (REF 7210542) when blades are inserted with the blade window aligned to the suction control lever.

Smith & Nephew DYONICS™ Power Shaver System Operations/Service Manual

Operation (continued)

Blade Window Lock Press the WINDOW LOCK button on the footswitch to rotate the blade until it is in the best stopping position for the procedure. You can also rotate the blade to a new stop position by simultaneously pressing the Slower and Faster buttons on the control unit front panel. If you are using a Hand Control Shaver Handpiece, press and hold the Oscillate button down to advance the blade, and release the button when the blade is in the desired position. If Blade Window Lock does not operate in a smooth, quiet manner, reset software by switching the handpiece channels or by turning the control unit power OFF and then ON.

Warning: Periodic irrigation of the tip of the burr or cutter is recommended to provide adequate cooling of the blade and to prevent accumulation of excised materials in the surgical site. Ensure that suction of 128 mmHg minimum is provided while the instrument is running.

Blade Speed When the Smith & Nephew DYONICS™ Power Shaver System is turned on, the system sets the default blade speeds for all blade types (blade types are not recognized by the UltraLight Handpiece). As blades and set speeds are changed, the system recalls the speed set for each blade type.

Blade family Recall Note: Blade types are not recognized by the POWERMAX Shaver Handpiece (REF 7210542) when blades are inserted with the blade window aligned to the suction control lever.

To set Forward and Reverse blade speed: 1. On the handpiece, press the Forward or Reverse button. 2. On the control unit, press the Faster button once to increase the speed by one increment. Press the Slower button once to decrease the speed by one increment. 3. Press and hold a speed control button to quickly make large adjustments to set speed.

Note: To set blade speeds to factory settings, press and hold Diagnostic Display button ( ! ) on the front panel of control unit while turning power to ON.

To set Oscillate speed: 1. On the handpiece, press the Oscillate button. 2. Press the Slower or Faster buttons once to decrease or increase the speed by 100 rpm. There are 26 Oscillate speed settings in 100 rpm increments starting with the minimum speed. Caution: Do not allow the rotating portion of any blade or burr to touch any metallic object such as a cannula or arthroscope. Damage to both instruments is likely. Damage to the blade can range from a slight distortion or dulling of the blade edge to actual fracture of the tip in vivo. If such contact does occur, inspect the tip. If you find cracks, fractures or dulling, or if you have any other reason to suspect a blade is damaged, replace it immediately. Caution: Excessive side-loading on the blade does not improve cutting performance and, in extreme cases, may result in wear and degradation of the inner assembly.

Note: Blade types are not recognized by the UltraLight Handpiece.

Smith & Nephew DYONICS™ Power Shaver System Operations/Service Manual

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Recommended System Configuration

IEC 60601-1-1 Compliant System Configuration for Smith & Nephew DYONICS™ Power Shaver System Figure 13 indicates a system configuration that complies with IEC 60601-1-1 requirements.

Warning: If this unit is configured as part of a system, the entire system should be tested for compliance with IEC 60601-1-1. • If the leakage current of the configured system exceeds the limits of IEC 60601-1-1, install an appropriately rated UL 2601-1/IEC 60601-1 approved isolation transformer and retest the system. • The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include: – Use of the accessory in the patient vicinity. – Evidence that the safety certification of the accessory has been performed in accordance with UL 2601-1/IEC 60601-1 and/or IEC 60601-1-1. Smith & Nephew LEVELERT ™ Fluid Level Sensors REF 3982 Images (OSD) On Screen Display

Smith & Nephew INTELIJET™ Arthroscopic Fluid Management System Control Unit

VAC

Arthroscopic Shaver System Smith & Nephew DYONICS™ Power System or Smith & Nephew DYONICS EP-1 System or Smith & Nephew DYONICS PS3500EP System

VAC

100–240 VAC 10A 50–60 Hz

Smith & Nephew INTELIJET™ Arthroscopy Cart REF 7205077

Footswitch

Smith & Nephew INTELIJET™ Suction Supply REF 4352

Multiple Socket Outlet REF 85010070 10A, 250 VAC

Handpiece

VAC

Figure 13. IEC 60601-1-1 System Configuration

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Smith & Nephew DYONICS™ Power Shaver System Operations/Service Manual

Recommended System Configuration

IEC 60601-1-1 Compliant System Configuration for Smith & Nephew DYONICS™ Power HERMES-Ready… Shaver System Figure 14 indicates a system configuration that complies with IEC 60601-1-1 requirements.

Warning: If this unit is configured as part of a system, the entire system should be tested for compliance with IEC 60601-1-1. • If the leakage current of the configured system exceeds the limits of IEC 60601-1-1, install an appropriately rated UL 2601-1/IEC 60601-1 approved isolation transformer and retest the system. • The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include: – Use of the accessory in the patient vicinity. – Evidence that the safety certification of the accessory has been performed in accordance with UL 2601-1/IEC 60601-1 and/or IEC 60601-1-1.

HERMES® Pendant

HERMES® Digital O.R. Control Center

Smith & Nephew DYONICS™ Power HERMES-Ready… Shaver System

Figure 14. IEC 60601-1-1 System Configuration for HERMES-Ready… Control Unit

Smith & Nephew DYONICS™ Power Shaver System Operations/Service Manual

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