Dyonics POWER Shaver System Operations and Service Manual Rev T

Glossary of Symbols

Dangerous Voltage: Danger of electric shock

Equipment classification- Type B equipment

Watertight equipment per IEC 529

Power On Connection to the mains

Suction On Fluid flow through handpiece unrestricted

Protective earth (ground)

Power Off Disconnection from the mains

Suction Off Fluid flow through handpiece blocked

Alternating current

Diagnostic Display Button Displays diagnostic codes

Non-Sterile

Faster Increase shaver speed

Forward Clockwise direction of shaver rotation (distal view)

UL classification

Handpiece Shaver motor drive unit

Reverse Counterclockwise direction of shaver rotation (distal view)

This way up

Footswitch Food pedal control

Oscillate Alternating forward/reverse direction of shaver rotation

Fragile; handle with care

Minimum Lowest shaver speed value

Blade Window Lock Adjustment of cutting window stop position

Humidity

Maximum Highest shaver speed value

Non-ionizing electromagnetic radiation

EU: Not for general waste

Speed Shaver rotation rate in revolutions per minute

Fuse

Service lifetime in years

Bidirectional port

Equipotentiality

Slower Decrease shaver speed

DYONICS™ POWER Shaver System

!

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Preface/Table of Contents

Preface This manual provides the information required to operate and maintain both the basic and Digital OR-Ready Smith & Nephew DYONICS™ POWER Shaver Systems. It is essential that all the information in this manual be read and understood before using or maintaining these systems. Information that pertains only to the Digital OR-Ready Shaver System (REF 7209912) is included where applicable.

Table of Contents Glossary of Symbols... 3 Preface... 4

IEC 60601-1-1 Compliant System Configuration for Smith & Nephew DYONICS™ POWER Shaver System... 19

Table of Contents... 4

Maintenance... 20

Device Description... 5

Electrical Interference... 20

Digital OR-Ready System Information... 6

Environmental Protection... 20

Indications for Use... 6

Service... 23

Contraindications... 6

Control Unit Fuses... 23

Warnings... 7

Troubleshooting... 24

Preventive Maintenance... 20

Precautions... 8

To Follow Up on Fault Indicator... 24

Peripheral Devices... 9

Technical Specifications, Shaver System... 26

Handpieces and Powered Instruments... 9

Environmental Conditions... 26

Footswitches... 9 Unpacking and General Inspection... 10

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions... 27

U.S. Control System (REF 7205886)... 10

Guidance and Manufacturer’s Declaration – Guidance for Separation Distances... 27

International Control System (country-specific)... 10

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity... 28

Display Window... 12

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity... 29

Blade Family Recall... 12 Indicator Lights... 12 Footswitch... 14 Blade Window Lock... 14 Setup... 15

Warranty... Back Cover Service Replacement Units Warranty... Back Cover Service Replacement Program... Back Cover Repair Service Program... Back Cover

Operation... 16 Blade Motor Control... 16 Blade Selection... 16 Blade Window Lock... 17 Blade Speed... 17 Blade Family Recall... 17 Set Forward and Reverse Blade Speed... 18 Set Oscillate Blade Speed... 18

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Device Description

Device Description 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. The shaver footswitch allows selection of 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 control unit displays user prompts and system diagnostic codes and provides settings for the blade speed within minimum and maximum speeds, preprogrammed for each blade type. The control unit can also drive high-powered arthroscopic instruments (i.e., drills, wire/pin drivers, sagittal saws), purchased separately. 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, allowing the surgeon to control shaver operation without the need for a footswitch. The mini shaver handpiece uses smaller blades for small-joint surgery and functional endoscopic sinus surgery (FESS) applications. 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 do not fit the Smith & Nephew DYONICS POWER Ultralight Motor Drive.

• 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, REF 72200616, 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 digital OR control center voice command and/or touch screen control of SPEED up and SPEED down, Blade Window Lock, and Port A or Port B selection. • Optional hand control shaver handpieces feature 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.

The shaver system features many performance and ease-of-use advantages, including: • Intuitive front panel display and controls provide an immediate understanding and control of system performance. • The system automatically detects the blade type in use and sets the operating parameters accordingly. • When blades are changed, Blade Family Recall automatically returns to the previous speed settings in Forward/Reverse and Oscillate modes (blade types are not recognized by the Ultralight Motor Drive).

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Digital OR-Ready System Information/Indications for Use/Contraindications

Digital OR-Ready System Information The Smith & Nephew DYONICS™ POWER Digital ORReady Shaver System is configured to be connected to the digital OR control center via the bidirectional (digital OR-ready) 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 digital OR control center. Please refer to the digital OR control center operations/ service manual for the proper setup, use, and troubleshooting of the Voice Control Interface portion of that device. When the digital OR control center is connected and active, the function parameters of the shaver system may alternatively be adjusted using the buttons on the front panel. For troubleshooting or further information, please refer to the digital OR control center operations/ service manual

Contraindications 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 Smith & Nephew TURBOWHISKER™ Blades and 2.9 mm Cutter Blade are contraindicated for the FESS application.

Indications for Use The Smith & Nephew DYONICS POWER control unit 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 for functional endoscopic sinus surgery (FESS). The FESS application is limited to those small blades which are appropriate for the procedure.

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Warnings

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. • Only Smith & Nephew DYONICS™ Disposable Endoscopic Blades can be used with the Smith & Nephew DYONICS POWER Shaver System. • When connecting peripheral and accessory devices to the DYONICS POWER Shaver System, use only cables that have been validated for use with the system. Non-validated cables may damage the control unit and create electrical hazards. The use of non-validated cables will void the warranty. • DANGER: Risk of explosion if used in the presence of flammable anesthetics. This device is not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. • Periodic irrigation of the blade 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. Do not operate the handpiece in the open air for an extended period, as the lack of irrigation may cause the blade or burr to overheat and seize. • 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 testing. Ensure that the cover is on the DYONICS POWER Control Unit before beginning testing. • Check that the electrical equipment is properly grounded (i.e., plugs contain a ground prong). Grounding reliability can be achieved only when the DYONICS POWER Shaver System is connected to an equivalent AC power receptacle marked “hospital only” or “hospital-grade.”

• 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 60601-1/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 60601-1/IEC 60601-1 and/or IEC 60601-1-1. • When using a footswitch, ensure that the footswitch is not accidentally activated while inserting the blade or burr, or while plugging the connector cable into the control unit. • Inadvertently depressing a footswitch while plugging in a handpiece or powered instrument will activate the handpiece or powered instrument. • Depressing a footswitch will activate the powered instruments even when they are in the “SAFE” position. • To avoid patient burns, do not place the powered instrument on the patient when it is not in use. • Refer to the Smith & Nephew DYONICS Handpieces Instructions for Use (REF 10600266) for the warnings and precautions associated with the handpieces. • Refer to the Smith & Nephew DYONICS Powered Instruments Instructions for Use (REF 10600341) for the warnings and precautions associated with the powered instruments. • Refer to the Smith & Nephew DYONICS Disposable Endoscopic Blades Instructions for Use (REF 1060595) for the warnings and precautions associated with the blades.

• Dangerous voltages are present during leakage current testing. Do not touch the control unit while power is applied.

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Precautions

Precautions U.S. Federal law restricts this device to sale by or on the order of a physician. • Prior to each use, inspect the device to ensure it is functioning properly and not damaged. Do not use a damaged device. • In all cases, the judgment of the physician (in the best interest of the patient) may take precedence over the procedures described in this manual. • 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 the Smith & Nephew DYONICS™ POWER Shaver System. Use of such products will void the warranty. • Use of reprocessed, single-use shaver blades may permanently damage, impede performance, or cause failure of the DYONICS POWER Shaver System. Use of such products will void the warranty. • 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 there are cracks, fractures or dulling, or if there is any other reason to suspect a blade is damaged, replace it immediately. • To prevent damage to the control unit connector ports, do not plug in wet. Ensure that cleaned or sterilized cable connectors are completely dry prior to connecting to the control unit, handpiece or powered instrument. • 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. • Dried blood, saline, and other deposits inside the handpieces are a major cause of equipment malfunction. • 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.

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• 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. • Electrical Interference: 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. • Environmental Protection: 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. • The bidirectional port on the control unit (Digital OR-Ready) is not a USB protocol-supported connection. Only connect the shaver system to a digital OR control center. • Irreversible damage will result from any attempt to disassemble curved blades. • Excessive risk (leakage current) may result if this equipment is connected to a power distribution system other than the manufacturer’s recommended power distribution system. • This device has been tested and verified to comply with IEC 60601-1-2 (EN 55011). This exceeds the requirements specified by FCC Part 18 for ISM equipment. This device is intended for operation in a medical facility only. Usage in a residential environment will likely cause unacceptable RF interference for which the user is held responsible. • Handle the unit with care. If the unit is dropped or damaged in any way, it must be returned immediately for service. • Inspect all components regularly for wear. Pay particular attention to potential damage to insulation, especially with universal extension cables. DYONICS™ POWER Shaver System

Operations/Service Manual

Peripheral Devices

Peripheral Devices Handpieces and Powered Instruments A variety of DYONICS™ handpieces and powered instruments can be used with the shaver system. All handpieces and powered instruments can be connected to either the A or B connection port on the control unit front panel (Figure 1). The control unit automatically detects the type of handpiece or powered instrument connected. For information regarding handpieces and powered instruments that may be used with the shaver system, refer to the DYONICS Handpieces Instructions for Use (REF 10600266) or the DYONICS Powered Instruments Instructions for Use (REF 10600341). Handpieces and powered instruments are sold separately from the shaver system.

Footswitches The shaver system can use a wired footswitch to control blade action. Typical footswitches control forward, reverse, oscillate, and Blade Window Lock modes of operation. A footswitch is required when using the Standard Shaver Handpiece (REF 7205355), the Ultralight Motor Drive (REF 7205971), the POWERMAX™ Handpiece (REF 7210586), the POWERMAX ELITE Handpiece (REF 72200617), or the Mini Motor Drive Handpiece (REF 7205357). A footswitch may also be used with the hand-control handpieces and powered instruments.

DYONICS Low Profile Footswitch (REF 7205399)

DYONICS Low Profile Variable (“Accelerator”) Footswitch (REF 7205397) The low profile variable footswitch allows the FORWARD, REVERSE, and OSCILLATE buttons to control speed as well as blade direction. The low profile and low profile variable footswitches are comprised of a combination of contact switches and analog footpads. For the Forward, Reverse or Oscillate pads, maximum pressure establishes 100% of set speed with each new press. Decreasing pressure on the pad allows deceleration of the handpiece until the handpiece stops.

DYONICS Pedal-Style Footswitch (REF 7205396) The pedal-style footswitch features two foot pedals to control blade action. This footswitch is comprised only of contact switches. They operate in the On/Off mode, in which each press of the Forward or Reverse pedal starts or stops the handpiece. Press the Forward and Reverse pedals simultaneously for Oscillate mode.

Smith & Nephew Shaver Interface Cables (optional) The DYONICS POWER Shaver System is designed for use with the DYONICS 25 Fluid Management System and the INTELIJET™ Fluid Management System to offer automatic suction control. The DYONICS 25 Shaver Interface Cable (REF 91000973) connects the DYONICS POWER Shaver System to the DYONICS 25 System Control Unit. The INTELIJET Shaver Interface Cable (REF 91000268) connects the DYONICS POWER Shaver System to the INTELIJET Control Unit.

The low profile footswitch has FORWARD, REVERSE, and OSCILLATE control buttons and a WINDOW LOCK button. Pressing a footswitch button signals the shaver system to accelerate the blade until it reaches the set speed. Set speed is then maintained until the button is released. The buttons on the low profile footswitch are not throttles; they simply turn the handpiece on or off in the specified direction.

Note: The correct cable must be connected if the DYONICS 25 Control Unit or INTELIJET Control Unit automatic suction control feature is to be used.

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DYONICS™ POWER Shaver System

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Unpacking and General Inspection

Unpacking and General Inspection International Control System Carefully unpack and inspect all components shipped with the shaver system. If any parts are missing or damaged, contact an authorized Smith & Nephew representative. Save the carton and packing materials in the event a component must be returned for repair. The following parts should have been received:

U.S. Control System (REF 7205886) 1 ea Smith & Nephew DYONICS™ POWER Shaver System (REF 7205841) 1 ea Hospital-grade power cord (REF 605-0004) 1 ea Smith & Nephew DYONICS POWER Shaver System Operations/Service Manual (REF 1060801) 1 ea Smith & Nephew DYONICS Handpieces Instructions for Use (REF 10600266)

(country-specific)

Each international shaver system contains the following: 1 ea Smith & Nephew DYONICS POWER Shaver System (REF 7205841) 1 ea Hospital-grade power cord, country-specific 1 ea Smith & Nephew DYONICS POWER Shaver System Operations/Service Manual, country-specific version (REF 1060801) 1 ea Smith & Nephew DYONICS Handpieces Instructions for Use, country-specific version (REF 10600266) 1 ea Smith & Nephew DYONICS Powered Instruments Instructions for Use, country-specific version (REF 10600341)

1 ea Smith & Nephew DYONICS Powered Instruments Instructions for Use (REF 10600341)

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Front Panel Layout

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

Control/Connection

Function

1. Footswitch connection port

Receptacle for footswitch.

2. Display window

Displays minimum, maximum, and set speeds, blade direction, and diagnostic codes.

3. SLOWER button

Decreases the most recently set speed within the minimum and maximum speeds for the blade type.

4. Indicator light

Illuminates when the system detects a condition that requires attention.

5. Diagnostic display button

When pressed, causes the system to display one or more diagnostic codes.

6. FASTER button

Increases the most recently set speed within the minimum and maximum speeds for the blade type.

7. Port A and Port B

Receptacles for handpieces or powered instruments. The buttons above the ports allow selection of the handpiece connected to that channel. When a channel is selected, the light above the connection port is illuminated.

8. Power switch

The power ON/OFF switch for the entire system. The switch is illuminated when the system is on. Note: If system is turned off, wait at least 15 seconds before turning power on.

9. Slide-out diagnostic tray

DYONICS™ POWER Shaver System

Provides detailed information about diagnostic codes.

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Front Panel Layout (continued)

Display Window The control unit displays minimum, maximum and set speeds, blade direction (Forward, Reverse, or Oscillate) and diagnostic codes. The first line displays Forward (>>) and Reverse (<<) arrows to indicate blade direction. A horizontal bar graph between the direction symbols indicates the current speed of the blade relative to the speed range for the blade type. The second line, from left to right, displays minimum speed, the currently set speed, and the maximum speed. The shaver system senses the type of blade installed in the handpiece and sets the minimum and maximum speeds accordingly (blade types are not recognized by the Ultralight Motor Drive). Use the SLOWER and FASTER push buttons below the display window to adjust the blade speed. Figures 2, 3, and 4 provide examples of how the screen displays blade speed and direction.

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.

Blade Family Recall Blade Family Recall ensures that the last settings (Forward, Reverse, or Oscillate modes) for a blade “family” (e.g., straight, curved, and burrs) become the default the next time that family of blades is used, even after the unit is turned off. Note: Blade types are not recognized by the Ultralight Motor Drive.

Figure 2. Forward rotation

The blade is rotating forward (>>) at 2700 rpm. The minimum and maximum speeds for the blade in use are 100 rpm and 5000 rpm, respectively.

Figure 3. Reverse rotation

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

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To reset factory defaults, press and hold the diagnostic display button ( ! ) while turning the power on.

Indicator Lights When the shaver system detects a condition that requires attention, a red indicator light on the front panel is illuminated. When the diagnostic display button ( ! ) 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 (refer to the Troubleshooting section of this manual for further information). Green indicator lights above the footswitch and handpiece connectors flash to indicate a condition pertinent to the affected connector.

DYONICS™ POWER Shaver System

Operations/Service Manual

Rear Panel Layout

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

Control/Connection

Function

1. Equipotential compensator terminal

Permits connection of the shaver system control unit to an external grounding system.

2. 3-prong electrical connection port

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 control unit power supply automatically detects the local power standard and sets the unit to convert the supplied voltage.

3. 25-pin serial connection port

Links the shaver system to other Smith & Nephew equipment such as the INTELIJET™ Fluid Management System and the on-screen display module. Information regarding this connection is contained in the manual for the specific equipment.

4. Bidirectional port Allows connection to a digital OR control center. When connected, the following (Digital OR-Ready only) shaver functions can be controlled by voice and/or touch screen commands. π Speed up and speed down π Blade Window Lock π 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 bidirectional port on the control unit (Digital OR-Ready) is not a USB protocol-supported connection. Only connect the shaver system to a digital OR control center.

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Footswitch

Footswitch The footswitch is required when using the standard shaver handpiece, the Ultralight Motor Drive, 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 to control blade action (Figure 6). The footswitch, which plugs into the connection port 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.

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 the button is released.

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 press of the WINDOW LOCK button rotates the blade 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:

Figure 6. Smith & Nephew DYONICS™ POWER System Low Profile 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 the button is released. The footswitch buttons are not throttles; they simply turn the motor drive on or off in a specific direction.

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• The accelerator footswitch allows the FORWARD, REVERSE, and OSCILLATE buttons to control speed as well as blade direction. • The pedal style footswitch features two foot pedals to control blade action.

DYONICS™ POWER Shaver System

Operations/Service Manual

Setup

Setup WARNING: DANGER: Risk of explosion if used in the presence of flammable anesthetics. This device is not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. To set up the shaver system for use in a surgical procedure: 1. Place the control unit on the instrument cart and plug the power cord into the rear panel connection port 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 Port A or Port B on the front panel. Push-on connectors: 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 connector plug by aligning the red dots on the plug and the panel. Push the plug into the connection port and release the locking sleeve. The handpiece cable is fully engaged when the red dots are aligned.

The system automatically selects Port A on power up. If a handpiece is connected to Port B, press the Port B button to select it. If handpieces are connected to both ports, press the Port A or Port B button to select a handpiece. If the connected handpiece is the hand control shaver handpiece, the footswitch indicator light stops blinking. However, the footswitch can still be connected to control the shaver by foot. 4. Plug the footswitch cable into the connection port 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 3000 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 shows the motor accelerating to 2000 rpm, while the directional arrows indicate forward rotation (>>). The handpiece motor action can be observed 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.

Twist-on connectors: Unscrew the 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 aligned.

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Operation

Operation

With the accelerator footswitch, 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.

WARNING: Only Smith & Nephew DYONICS™ Disposable Arthroscopic Surgery Blades can be used with the Smith & Nephew DYONICS POWER Shaver System.

To activate the hand control shaver handpiece, press and release the FORWARD, REVERSE, or OSCILLATE button. The blade operates in the selected mode until any button is pressed, which stops the motor. Press another button to restart or change direction.

Blade Motor Control The button controls on the footswitch allow selection of three cutting actions: Forward, Reverse, and Oscillate. With the standard low profile footswitch, the blade rotates in the direction specified, accelerates to the set speed, and continues until the release of the footswitch button.

Table 1. Programmed Blade Speeds Handpiece

Blade/Burr Type

Forward (RPM)

Reverse (RPM)

Oscillate Mode 1 (RPM)

Range

Default

Range

Default

Range

Default

Long Blades (Straight and Curved), TURBOWHISKER™

100–3000

2000

100–3000

2000

500–3000

2000

DYONICS POWERMAX™ 3.5 mm Curved (REF 7210542, Blade 7210586, 7209891)

100–3000

2000

100–3000

2000

500–3000

2000

DYONICS POWERMAX ELITE (REF 72200616, 72200617)

Curved, HELICUT™ and Orbit™ Curved Blades

100–5000

2000

100–5000

2000

500–3000

2000

Straight ELECTROBLADE™

100–5000

2000

100–5000

2000

500–3000

2000

Burrs, Long Burrs and BONECUTTER™ Blades

500–8000

4000

500–8000

4000

500–3000

2000

ELITE Burr*

500–10000

5000

500–10000

5000

500–3000

2000

DYONICS POWER Ultralight Motor Drive (REF 7205971)**

Ultra Series

100–5000

3000

100–5000

3000

500–3000

1000

DYONICS Mini Motor Drive (REF 7205357)

Burrs and Blades

100–3500

2000

100–3500

2000

500–3000

1000

DYONICS POWER (REF 7205354, 7205355)

* ELITE burrs run only in POWERMAX ELITE Handpieces (REF 72200616, 72200617). ** All standard burrs run at 5000 rpm when used in the Ultralight Motor Drive (REF 7205971).

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Operation (continued)

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 7), while Forward mode is more efficient for cutting hard, osseous tissue (Figure 8). Note: All blade speeds can be set in increments of 100 rpm in Forward/Reverse mode.

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

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. The blade can be rotated to a new stop position by simultaneously pressing the SLOWER and FASTER buttons on the control unit front panel. If using a hand control shaver handpiece, press and hold the OSCILLATE button 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 blade 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. Do not operate the handpiece in the open air for an extended period, as the lack of irrigation may cause the blade or burr to overheat and seize.

Figure 7. Cutting efficiency with soft tissue

Blade Speed When the shaver system is turned on, the system sets the default blade speeds for all blade types.

Blade Family Recall As blades and set speeds are changed, the system recalls the speed set for each blade type. Note: Blade types are not recognized by the Ultralight Motor Drive.

Figure 8. Cutting efficiency with osseous tissue

DYONICS™ POWER Shaver System

Operations/Service Manual

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Operation (continued)

Set Forward and Reverse Blade Speed 1. On the handpiece, press the FORWARD or REVERSE button. 2. On the control unit, press the FASTER or SLOWER button once to increase or 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 the diagnostic display button ( ! ) on the front panel of control unit while turning power on.

Set Oscillate Blade Speed 1. On the handpiece, press the OSCILLATE button. 2. On the control unit, press the FASTER or SLOWER button once to increase or decrease the speed by 100 rpm. There are 26 oscillate speed settings in 100 rpm increments starting with the minimum speed.

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1060801 Rev. T

WARNING: Periodic irrigation of the blade 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. Do not operate the handpiece in the open air for an extended period, as the lack of irrigation may cause the blade or burr to overheat and seize. 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 there are cracks, fractures, or dulling, or if there is 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.

DYONICS™ POWER Shaver System

Operations/Service Manual

Recommended System Configuration

IEC 60601-1-1 Compliant System Configuration for Smith & Nephew DYONICS™ POWER Shaver System Figure 9 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 60601-1/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 60601-1/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 9. IEC 60601-1-1 system configuration DYONICS™ POWER Shaver System

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19

Cleaning Control Unit and Footswitch/Maintenance

Cleaning Control Unit and Footswitch

CAUTION: Electrical safety testing should be performed by a biomedical engineer or other qualified person.

Follow this procedure after each operation to clean the control unit and the footswitch:

Do not open the cover of the unit. Smith & Nephew will not be liable for repair or replacement if damage occurs.

1. Disconnect the control unit from the electrical source.

The following equipment is required for these tests:

2. Wipe the control unit with a clean damp cloth and mild germicide or isopropyl alcohol.

• Dielectric strength tester (Refer to UL 60601 and IEC 60601-1)

CAUTION: Do not sterilize or immerse the Smith & Nephew DYONICS™ POWER Control Unit in disinfectant.

• High-current-sourcing ground resistance tester (Hypatia Model 307 or equivalent)

3. Wipe the footswitch and footswitch cable with a clean damp cloth. The low profile, button-style footswitches and pedal footswitch are watertight per IPX8.

Maintenance Electrical Interference CAUTION: 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.

Environmental Protection CAUTION: 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.

Preventive Maintenance Electrical Safety Checks Smith & Nephew recommends that dielectric strength, ground continuity, and leakage current testing be performed annually to assure continued compliance with applicable safety requirements. These tests should be conducted in accordance with specifications UL 60601-1/IEC 60601-1. 20

1060801 Rev. T

• Dale safety analyzer (LT544D-20) • Dale safety analyzer (LT544D-20E with IEC 60601 Load or equivalent). See “Leakage Current Test”.

Dielectric Strength Test WARNING: 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 testing. Ensure that the cover is on the DYONICS POWER Control Unit before beginning testing. To perform a dielectric strength test: 1. Turn the dielectric strength tester (DST) off and set the voltage knob to the minimum. Separate the DST test lead clips by at least one inch. Do not allow the clips to contact any personnel or conductive surface. 2. Connect the DST to its power source. 3. Turn the DST on. 4. Switch the test button on, then gradually adjust the voltage up to 1500 VAC to verify that the tester is working properly. 5. Turn the DST’s voltage adjustment down to the minimum setting. Turn the DST off. 6. Connect the output (or “high voltage”) line from the DST to the control unit power cable’s hot and neutral pins. Connect the DST input (“return” or “ground”) line to the control unit cable’s ground pin. 7. Make sure that the DST’s voltage setting is adjusted to the minimum value. Turn the control unit power switch on. 8. Turn the DST on. Turn the TEST switch on. DYONICS™ POWER Shaver System

Operations/Service Manual

Maintenance (continued)

Leakage Current Test 115 VAC with Power On

9. Increase the voltage adjustment on the DST until 1500 VAC is reached.

Test equipment: Dale Model LT544D-20 safety analyzer (115 VAC) or equivalent. Refer to Table 2.

10. Allow the test to run for at least one second. The control unit passes if the dielectric strength alarm does not sound.

1. Connect safety analyzer to 115 VAC/60 Hz power source.

11. If the unit fails the 1500 VAC test, contact Smith & Nephew Customer Service.

2. Connect the unit under test (UUT) to a safety analyzer receptacle.

Ground Continuity Test

3. Connect the chassis cable from the safety analyzer to the UUT chassis (ground stud).

To conduct the ground continuity test: 1. Connect the power cord to the control unit receptacle. Do not connect the other end of the AC cord.

4. Turn UUT power on. 5. Connect the motor drive unit (MDU) (REF 7205354) to Port A on the control unit.

2. Connect the ground resistance tester to 115 VAC. Ensure that the power switch is off.

6. Set the safety analyzer switches to the positions indicated in Table 2 and record the test measurement.

3. Connect the tester’s leads to the control unit power cord ground pin (round) and the center cover mounting screw.

Note: Press any hand control button on the MDU to run the motor at its default speed during each NEUTRAL-CLOSED leakage test.

4. Turn the tester on. It should read less than 0.1 Ω (ohms).

Note: Pause the POLARITY switch in the center off position for approximately one second before changing from NORMAL to REVERSED or REVERSED to NORMAL polarity.

Table 2. 115 VAC 60 Hz Leakage Current Test NEUTRAL Switch

POLARITY Switch

LEAKAGE Switch

FUNCTION Switch

Measurement

Specification

CLOSED

NORMAL

CLOSED

NORMAL

Pass / Fail

CENTER

LINE V

VAC

108 to 132 VAC

P

F

CENTER

LEAKAGE I

µA

≤ 85 µA

P

F

CLOSED

NORMAL

CHASSIS

LEAKAGE I

µA

≤ 425 µA

P

F

CLOSED

REVERSED

CENTER

LEAKAGE I

µA

≤ 85 µA

P

F

CLOSED

REVERSED

CHASSIS

LEAKAGE I

µA

≤ 425 µA

P

F

OPEN

REVERSED

CENTER

LEAKAGE I

µA

≤ 425 µA

P

F

OPEN

NORMAL

CENTER

LEAKAGE I

µA

≤ 425 µA

P

F

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