RENASYS
DYONICS Instrument Power Controllers
Dyonics POWER II Control System Operations and Service Manual Rev J Jan 2017
Operations and Service Manual
40 Pages
Preview
Page 1
Glossary of Symbols Follow instructions for use
Suction off - fluid flow through handpiece blocked
Ethernet port
Follow instructions for use
Authorized representative in the European community
Catalog number
On/Off
Input/output
Type B applied part
Forward - clockwise direction of shaver rotation (distal view)
Serial interface
Equipotentiality
Reverse - counterclockwise direction of shaver rotation (distal view)
Dangerous voltage
EU: Not for general waste
Oscillate - alternating forward/reverse direction of shaver rotation
USB port
This way up
Blade window lock - blade rotation while setting blade window lock
Alternating current
Fragile: handle with care
Up and down buttons
Environmentally friendly use period
Left footswitch pedal
Footswitch connected icon
Temperature limitation
Right footswitch pedal
Powered drill icon
Humidity limitation
Blade window lock adjustment of cutting window stop position
Shaver icon
Oscillate footswitch pedal
Lavage start/stop
Saw icon
TUV classification
Footswitch window lock
Pump icon
Non-ionizing electromagnetic radiation
Keep dry
Watertight equipment per IEC 529
Yes
CE mark
Suction on - fluid flow through handpiece unrestricted
No
Partinummer
Serial number
Manufacturer
Date of manufacture
DYONICS™ POWER II Control System
Operations/Service Manual
10600181 Rev. J
3
Preface/Table of Contents
Preface This manual contains information needed to operate and maintain the Smith & Nephew DYONICS™ POWER II Control System. It is essential that all the information in this manual be read and understood before using or maintaining this system.
Table of Contents Glossary of Symbols... 3
Cleaning and Sterilization... 29
Preface... 4
Control Unit... 29
Table of Contents... 4
Footswitch... 29
Device Description... 5
Handpieces and Powered Instruments... 29
Indications for Use... 5
Service... 30
Contraindications... 5
Service Information... 30
Warnings... 6
Replace Rear Panel Fuses... 30
Precautions... 7
Maintenance... 30
System Components... 8
Preventive Maintenance... 30
Peripheral Devices... 8
Troubleshooting... 31
Handpieces and Powered Instruments... 8
Observed Problems... 31
Footswitches... 8
Warning Message Table... 32
Unpacking and General Inspection... 10
Fault Message Table... 33
U.S. Control System (REF 72201030)... 10
Technical Specifications... 34
International Control System (Country-specific)... 10 Other Indicators... 14 Recommended System Configuration... 15 Control Unit Setup... 16
Environmental Conditions... 34 Factory Defaults... 34 Ordering Information/Accessories... 35 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions... 36
Settings... 19
Guidance and Manufacturer’s Declaration – Guidance for Separation Distances... 36
Blade Default Mode versus Blade Recall Mode... 19
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity... 37
Program Blade Settings... 20
Warranty... Back Cover
Program Footswitch Settings... 22
Service Replacement Units Warranty... Back Cover
Setting Pump Interface... 23
Service Replacement Program... Back Cover
Change System Language... 24
Repair Service Program... Back Cover
Review System Information... 24 Operation... 25 Device Motor Control... 25 Suction Control... 26 Blade Selection... 26
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DYONICS™ POWER II Control System
Operations/Service Manual
Device Description/Indications for Use/Contraindications
Device Description
Indications for Use
The Smith & Nephew DYONICS™ POWER II Control System consists of a main control unit and a country-specific power cord. A control system interface cable (optional) and a procedure cart (optional) may also be purchased.
The DYONICS POWER II Control System is indicated for use when used with appropriate procedure-specific blades, for resection of soft and osseous tissues including, but not limited to, use in large articular cavities, small articular cavities, and for functional endoscopic sinus surgery (FESS). The FESS application is limited to small blades that are appropriate for the procedure.
The control system provides for variable speed operation of handpieces and powered instruments (i.e., drills, wire/pin drivers, sagittal saws). The control unit has two instrument ports, allowing for simultaneous use of two handpieces, two powered instruments, or a combination of a handpiece and a powered instrument. A footswitch connection port is also available and can be configured to drive the instrument connected to either Port A or Port B. The control unit displays user prompts and system diagnostic text. The control unit can be used with the following: the Smith & Nephew DYONICS 25 Fluid Management System or the Smith & Nephew INTELIJET™ Fluid Management System. When the control unit is linked with either pump, the pump outflow regulation occurs, based on whether the blade is in use or idle. A variety of disposable straight and curved surgical blades and burrs can be inserted into the shaver handpiece for various surgical requirements. Blade action can be controlled by either the handpiece or a footswitch, selecting forward, reverse, or oscillate. The control unit provides settings for minimum and maximum blade speeds, preprogrammed for each blade type. This operations/service manual provides information about the DYONICS POWER II Control System and its proper use. For information regarding Smith & Nephew DYONICS Handpieces, refer to the Instructions for Use (REF 10600266). For information regarding Smith & Nephew DYONICS Powered Instruments, refer to the Instructions for Use (REF 10600341).
Contraindications Smith & Nephew DYONICS Handpieces and Blades should not be used with patients exhibiting ankylosis and also lacking adequate joint space or distention. 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 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 Smith & Nephew Mini Blade Cutter are contraindicated for the FESS application. The Smith & Nephew POWERMINI™ Blades and all large blades are contraindicated for the FESS application.
For information regarding the DYONICS Disposable Endoscopic Blades, refer to the Instructions for Use (REF 1060595). For information regarding the DYONICS 25 Fluid Management System, refer to the operations/service manual (REF 1061600). For information regarding the INTELIJET Fluid Management System, refer to the operations/service manual (REF 1060933). For information regarding the DYONICS POWER II Footswitch, refer to the instructions for use (REF 10600267).
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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. • The DYONICS™ 25 Fluid Management System and the INTELIJET™ Fluid Management System can be connected to the DYONICS POWER II Control System. The use of nonvalidated peripheral devices may damage the control unit and create electrical hazards. The use of non-validated peripheral devices will void the warranty. • When connecting peripheral and accessory devices to the DYONICS POWER II Control Unit, use only cables that have been validated for use with the control unit. Non-validated cables may damage the control unit and create electrical hazards. The use of non-validated cables will void the warranty. • Only Smith & Nephew DYONICS Disposable Endoscopic Blades can be used with the DYONICS POWER II Control System. • 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 avoid patient burns, do not place the handpiece on the patient when the handpiece is not in use. • 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 II Control Unit before beginning the tests. • Check that the electrical equipment is properly grounded (i.e., plugs contain a ground prong). Grounding reliability can be achieved only when the control unit 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. • If the leakage current of the configured system exceeds the limits of IEC 60601-1, install an appropriately rated 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. Consideration relating to the choice of accessory devices shall include: – Use of the accessory in the patient vicinity. – Evidence that the safety certification of the accessory has been performed in accordance with IEC 60601-1. • 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. • Refer to the documentation included with the DYONICS 25 Fluid Management System and the INTELIJET Fluid Management System for the warnings and precautions associated with those devices. • 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. • Do not use this device in oxygen rich environments (>25%).
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Operations/Service Manual
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 DYONICS™ POWER II Control 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 II Control System. Use of such products will void the warranty. • 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. • 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.
• Do not connect any equipment to the serial port unless it was designed by Smith & Nephew to communicate with the control unit via this port. • Check the Control screen to ensure that the proper settings are displayed prior to beginning any procedure. • Electrical safety testing should be performed by a biomedical engineer or other qualified person. • 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. • Use only one finger at a time when operating the LCD touch screen. Multiple, simultaneous finger presses can result in unintended changes to settings and erroneous control inputs. • Press the Power Up/Power Down button to turn off the control system. Failure to do so may result in lost custom settings. • Inspect all components regularly for wear. Pay particular attention to potential damage to insulation, especially with universal extension cables. • Do not sterilize or immerse the control unit in disinfectant.
– 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 policy relating to obsolete electronic equipment.
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System Components/Peripheral Devices
System Components The DYONICS™ POWER II Control Unit includes a Power Up/ Power Down button, an LCD screen, two connection ports for handpieces or powered instruments, a footswitch connection port, and rear panel connections for a variety of peripheral devices. The control unit’s LCD screen displays all of the controls needed to set up and operate the control unit, including adjusting settings, adjusting set speed, selecting oscillation modes, operating window lock, saving settings, and restoring settings to system defaults. The control system has been designed to meet IEC 60601-1 safety and performance standards for medical equipment. The CE mark on the control unit signifies compliance with Medical Directive 93/42/EEC.
Peripheral Devices Handpieces and Powered Instruments A variety of DYONICS handpieces and powered instruments can be used with the control unit. 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.
A footswitch is required when using the standard shaver handpiece (REF 7205355), the Ultralight shaver handpiece (REF 7205971), the POWERMAX™ Handpiece (REF 7210586), the POWERMAX ELITE Handpiece (REF 72200617), the POWERMINI™ Handpiece (REF 72201503) or the Mini Motor Drive Handpiece (REF 7205357). A footswitch also may be used with the handcontrol handpieces and powered instruments.
DYONICS POWER II Footswitch (REF 72201092) This footswitch communicates switch and pedal action to the control unit. It also supports the DYONICS 25 Fluid Management System’s lavage function and the blade window lock function. The footswitch operation can be modified using the Footswitch settings screen. Two modes are available: On/Off and Variable. Refer to the “Settings” section of this manual for more information. The footswitch has three control pedals and two switches. The pedals are labeled L, R, and <>. The L and R pedals default to reverse and forward, respectively. Depressing the left or right pedal causes the control unit to supply power to the handpiece to drive the blade in the direction indicated. The left and right pedals can be configured to run either forward or reverse. The center (<>) pedal is always oscillate. The two switches provide control for the blade window lock function and the DYONICS 25 Fluid Management System’s lavage function. The footswitch plugs into the footswitch connection port located on the front panel of the control unit (Figure 1).
For information regarding handpieces and powered instruments that may be used with the control unit, refer to the DYONICS Handpieces Instructions for Use or the DYONICS Powered Instruments Instructions for Use. Handpieces and powered instruments are sold separately from the control unit.
Note: The footswitch does not control the Forward or Reverse Speed Shift settings. The <> (Oscillate) pedal causes the control unit to send alternate forward and reverse commands to the handpiece. The control unit continues the alternating signals until the foot is removed from the <> pedal.
Footswitches
For more information regarding the DYONICS POWER II Footswitch, refer to the instructions for use.
The control unit can use a wired footswitch to control blade action. Typical footswitches control forward, reverse, oscillate, and window lock modes of operation.
For information regarding the DYONICS 25 Fluid Management System, refer to the instructions for use.
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Operations/Service Manual
Peripheral Devices (continued)
DYONICS™ Low Profile Footswitch (REF 7205399)
Smith & Nephew Shaver Interface Cables (optional)
The low profile footswitch has three control buttons and a Window Lock button. The control buttons are labeled FORWARD, REVERSE, and OSCILLATE. Pressing a footswitch button signals the control unit 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.
The DYONICS POWER II Control 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 II Control Unit to the DYONICS 25 System Control Unit. The INTELIJET Shaver Interface Cable (REF 91000268) connects the DYONICS POWER II Control Unit to the INTELIJET Control Unit.
DYONICS Low Profile Variable (“Accelerator”) Footswitch (REF 7205397)
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.
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.
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Unpacking and General Inspection
Unpacking and General Inspection
International Control System (Country-specific)
Carefully unpack and inspect all components shipped with the Smith & Nephew DYONICS™ POWER II Control System. If any parts are missing or damaged, contact your 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:
Each international Smith & Nephew DYONICS POWER II Control System contains the following:
U.S. Control System (REF 72201030)
1 ea Smith & Nephew INTELIJET Shaver Interface Cable (REF 91000268)
1 ea Smith & Nephew DYONICS POWER II Control Unit (REF 72200873) 1 ea Smith & Nephew DYONICS 25 Shaver Interface Cable (REF 91000973) 1 ea Smith & Nephew INTELIJET™ Shaver Interface Cable (REF 91000268) 1 ea Hospital-grade power cord (REF 605-0004) 1 ea Smith & Nephew DYONICS POWER II Control System Operations/Service Manual (REF 10600181)
1 ea Smith & Nephew DYONICS POWER II Control Unit (REF 72200873) 1 ea Smith & Nephew DYONICS 25 Shaver Interface Cable (REF 91000973)
1 ea Hospital-grade power cord, country-specific 1 ea Smith & Nephew DYONICS POWER II Control System Operations/Service Manual, country-specific version (REF 10600181) 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 Handpieces Instructions for Use (REF 10600266) 1 ea Smith & Nephew DYONICS Powered Instruments Instructions for Use (REF 10600341)
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DYONICS™ POWER II Control System
Operations/Service Manual
Front Panel Layout
Figure 1. DYONICS ™ POWER II Control Unit Front Panel
Control/Connection
Function
1. Power Up/Power Down Button
Initiates the power up/power down procedures.
2. LCD Touch/Display Screen
Displays system controls, system information, and procedure information. CAUTION: Use only one finger at a time when operating the LCD touch screen. Multiple, simultaneous finger presses can result in unintended changes to settings and erroneous control inputs.
3. Port A
Receptacle for handpiece or powered instrument.
4. Port B
Receptacle for handpiece or powered instrument.
5. Footswitch Connection Port
Receptacle for footswitch.
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Rear Panel Layout
The two available rear panel layouts of the control unit are displayed in Figure 2a and Figure 2b.
Figure 2a. DYONICS™ POWER II Control Unit Rear Panel for units with serial numbers up to and including 5000
Controls/Connections
Function
1. Bidirectional Port 1
Serial communication connection to the DYONICS 25 Fluid Management System or the INTELIJET™ Fluid Management System.
2. Serial Ports A and B
Not currently used.
3. Bidirectional Port 2
Serial communication connection to Digital O.R. Control Center.
4. Bidirectional Port 3
Not currently used.
5. Equipotential Compensator Terminal (case ground)
Used to bring other equipment into the same case potential as the device.
6. Ethernet Port
Not currently used.
7. USB Ports (1, 2, and 3)
For authorized service use only.
8. Exhaust Fans
Provides system cooling.
9. Power Cord Connector
This receptacle is an integral part of the power input module and accommodates the hospital grade power cord accessory.
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Rear Panel Layout
Figure 2b. DYONICS™ POWER II Control Unit Rear Panel (Connectors shown with covers removed) for units with serial numbers 5001 or greater)
Controls/Connections
Function
1. Bidirectional Port 1
Serial communication connection to Digital O.R. Control Center.
2. Bidirectional Port 2
Serial communication connection to the DYONICS 25 Fluid Management System or the INTELIJET™ Fluid Management System.
3. USB Ports (1 and 2)
For authorized service use only.
4. Serial Ports A and B
Not currently used.
5. Bidirectional Port 3
Not currently used.
6. Equipotential Compensator Terminal (case ground)
Used to bring other equipment into the same case potential as the device.
7. Power Cord Connector
This receptacle is an integral part of the power input module and accommodates the hospital grade power cord accessory.
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LCD Screen Layout
Figure 3. Control screen indicating attachment(s), directional arrows, speed settings, variable control buttons, change mode ( Mode) button, and blade window lock button.
Other Indicators Warning Messages If the control unit detects a problem, it displays a yellow warning message box at the bottom of the Port window (Figure 4). Depending on the problem, the system may also beep. Touch the warning message box to open a full description of the error. Press the OK button to close the warning message box and return to the prior screen.
Fault Messages When the system encounters a system fault, it stops all shaver operation, sounds an alarm, clears the current screen, and displays the fault message. A complete list of fault messages is listed in the Fault Message Table.
A complete list of warning messages is listed in the Warning Message Table.
Figure 4. Warning message
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Recommended System Configuration
Recommended System Configuration Figure 5 indicates a system configuration that complies with IEC 60601-1 requirements. WARNING: If this unit is configured as part of a system, the entire system should be tested for compliance with IEC 60601-1. • If the leakage current of the configured system exceeds the limits of IEC 60601-1, install an appropriately rated 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. Consideration relating to the choice of accessory devices shall include: – Use of the accessory in the patient vicinity. – Evidence that the safety certification of the accessory has been performed in accordance with the appropriate IEC 60601-1.
Figure 5. Recommended configuration for DYONICS™ POWER II Control System
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Control Unit Setup
Control Unit Setup WARNING: The DYONICS™ 25 and the INTELIJET™ Fluid Management Systems can be connected to the DYONICS POWER II Control System. The use of non-validated peripheral devices may damage the control unit and create electrical hazards. The use of non-validated peripheral devices will void the warranty. WARNING: When connecting peripheral and accessory devices to the DYONICS POWER II Control Unit, use only cables that have been validated for use with the control unit. Non-validated cables may damage the control unit and create electrical hazards. The use of nonvalidated cables will void the warranty. CAUTION: Use only one finger at a time when operating the LCD touch screen. Multiple, simultaneous finger presses can result in unintended changes to settings and erroneous control inputs. CAUTION: 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. 1. Plug the control unit power cord into the rear panel power cord connection port and a grounded AC power source. Note: Accessory devices such as handpieces, drills, pumps, etc. may be plugged into the front and rear panels either before or after powering up the control unit. WARNING: Check that the electrical equipment is properly grounded (i.e., plugs contain a ground prong). Grounding reliability can be achieved only when the control unit is connected to an equivalent AC power receptacle marked “hospital only” or “hospital-grade.” 2. Press the Power Up/Power Down button to turn the control unit on.
Figure 6. Smith & Nephew splash screen
3. The system will briefly display the Smith & Nephew splash screen (Figure 6) before displaying the Control screen (Figure 7). The Control screen displays connected devices and their status in the Port A and Port B windows. The icon bar across the top of the Control screen displays icons for the pump status, footswitch status, and type of device connected. 4. Connect the device cable to the desired device connection port. A single device can be connected to either Port A or Port B, or two devices can be connected to Port A and Port B respectively. Each port will accept a handpiece, drill, or saw. Devices connected to Port A and Port B can be used simultaneously. WARNING: Inadvertently depressing a footswitch while plugging in a handpiece or powered instrument will activate the handpiece or powered instrument. WARNING: Depressing a footswitch will activate the powered instruments even when they are in the “SAFE” position. Note: Avoid pressing the trigger, throttle lever, or hand controls while attaching the instrument cable. If this occurs, the instrument will not run until the trigger, throttle lever, or button is released for one second and then activated. Note: The system automatically recognizes which type of device is connected to each port.
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Control Unit Setup (continued)
Note: When a handpiece is connected to the control unit for the first time, the Control screen will display the speed controls for Oscillate Mode 1 for that port. Refer to the “Settings” section of this manual for more information. • Push-on connectors: Handpiece cable connectors have a locking sleeve, which holds a protective cap. Pull the sleeve back to remove the cap. Orient the 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 cable is fully engaged when the red dots are aligned. Check the Control screen (Figure 7) to confirm connections and device recognition. The icon for the device connected to Port A appears in the icon bar above the Port A window on the left side of the screen. Icons associated with Port A appear in blue.
• When confirming operation, directional arrows immediately above the colored boxes animate and turn green. The directional arrows indicate forward rotation (>>). If the attached device does not specify forward operation, the direction of the arrows is determined by that device. • The handpiece motor action can be observed inside the distal end of the handpiece. 6. Verify Reverse (<<) and Oscillate (<<>>) modes. The directional arrows indicate Reverse rotation (<<) and Oscillation (<<>>). If the attached device does not specify Reverse or Oscillate operation, the direction of the arrows is determined by that device. 7. Connect the footswitch to the footswitch connection port on the front panel of the control unit. The footswitch connection port is located below the Port A connection port. A black ring designates the footswitch connection port. Check the Control screen to confirm the connection and footswitch recognition. The footswitch icon appears in the icon bar. The footswitch controls the device connected to Port A by default. The footswitch can be set to control the device connected to Port B. Refer to the “Settings” section of this manual for information on adjusting the footswitch settings. 8. Repeat Steps 5 and 6 for the footswitch controls to confirm proper operation of the footswitch-controlled device. 9. Optional: Connect the suction by sliding the suction tubing onto the outflow portal on the proximal end of the handpiece.
Figure 7. Control screen
The icon for the device connected to Port B appears in the icon bar above the Port B window on the right side of the screen. Icons associated with Port B appear in yellow. If there is no device connected to a port, the corresponding port window displays a connector icon.
10. Optional: Connect the pump and any other peripheral devices to the appropriate rear panel connection. Refer to the “Rear Panel Layout” section of this manual and the documentation supplied with the device being connected for more information.
5. Press the Forward button for the device attached to Port A to confirm operation. Press the Forward button for the device attached to Port B to confirm operation. If a device does not have a Forward button, press the equivalent (i.e., the trigger on a drill, a footswitch pedal) to confirm that device’s operation.
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Control Unit Setup (continued)
Control Unit Integration If the DYONICS™ POWER II Control Unit is connected to a DYONICS 25 Fluid Management System or a INTELIJET™ Arthroscopic Fluid Management System, a pump icon is displayed automatically in the icon bar above the Port A window. The pump defaults to the Port A device. The pump can be set to integrate with the Port B device by selecting the Port B button on the Pump Interface screen located in Settings. Note: A connected pump integrated with Port A responds to commands only from the device and footswitch connected to Port A. A connected pump integrated with Port B responds to commands only from the device and footswitch connected to Port B. Note: The DYONICS POWER II Footswitch lavage start/stop button works only when the footswitch and pump are assigned to the same port. Note: The DYONICS POWER II Footswitch lavage start/stop button works only with the DYONICS 25 pump. The Flush feature on the INTELIJET Control Unit must be activated using the Flush button on the front panel of the INTELIJET Control Unit. Note: The pump icon on the Control screen animates only when the control unit is connected to the DYONICS 25 Pump and the pump is pumping. To integrate the DYONICS POWER II Control Unit with a DYONICS 25 Control Unit or INTELIJET Control Unit: 1. Ensure that the fluid management system has been set up per the setup procedures in the Smith & Nephew DYONICS 25 Fluid Management System Operations/Service Manual or the Smith & Nephew INTELIJET Fluid Management System Operations/Service Manual (REF 1061409). 2. Ensure that the communications cable is connected into bidirectional port 1 (Figure 2a) or bidirectional port 2 (Figure 2b) on the rear panel of the DYONICS POWER II Control Unit. Note: If the bidirectional port has a cover attached, use a screwdriver to remove the cover before connecting the cable.
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a. Use the DYONICS 25 Shaver Interface Cable to connect the DYONICS POWER II Control Unit to the DYONICS 25 Control Unit. b. Use the INTELIJET Shaver Interface Cable to connect the DYONICS POWER II Control Unit to the INTELIJET Control Unit. 3. Connect the shaver interface cable to the fluid management system control unit. a. For the DYONICS 25 Control Unit, connect the cable to the shaver port on the rear panel of the control unit. b. For the INTELIJET Control Unit, connect the cable to the RS-232 communications port on the rear panel of the control unit. 4. Set the suction lever on the handpiece to the MAX (fully open) position. 5. Set the shaver suction settings. a. The DYONICS 25 Control Unit shaver suction settings are factory preset to 100% outflow while the handpiece is on and to 50% outflow when the handpiece is idle. Refer to the “Inflow/Outflow Tube Set, Shaver Detected Mode” section of the DYONICS 25 Control Unit Operations/Service Manual for more information. Note: To adjust the DYONICS 25 Control Unit custom shaver suction levels, refer to the “Settings” section of the DYONICS 25 Control Unit Operations/Service Manual for instructions. b. The INTELIJET control unit shaver suction settings can be modified from the front panel. The two indicator LEDs indicate whether the INTELIJET Control Unit is in SHAVER or FLUSH mode. When in SHAVER mode, use the Up and Down buttons to adjust the suction settings. When in FLUSH mode, use the Up and Down buttons to adjust the flush settings.
DYONICS™ POWER II Control System
Operations/Service Manual
Settings
Settings CAUTION: Use only one finger at a time when operating the LCD touch screen. Multiple simultaneous finger presses can result in unintended changes to settings and erroneous control inputs. Once all handpieces and other devices to be used during the procedure have been connected to the control unit and system operation has been verified, press the Settings button at the bottom of the Control screen to view the Settings screen (Figure 8). The Settings button is active whenever the handpieces and powered instruments are not running.
The Settings screen enables users to select the blade mode using the Select Blade Default button or the Select Blade Recall button. Footswitch, Pump Interface, and Language settings are automatically saved between each power down and power up. Blade settings are saved only when the control unit is set in Blade Recall mode. The Blade Reset function appears on the Settings screen only if a handpiece is connected to either Port A or Port B. The Blade Reset buttons reset the blade connected to the selected port to the factory default settings. Blade Reset does not change the oscillation mode previously selected for that port. Press Done to close the Settings screen and return to the Control screen.
Blade Default Mode versus Blade Recall Mode The DYONICS™ POWER II Control Unit can be operated in either the Blade Recall mode or the Blade Default mode.
Figure 8. Settings screen
The Settings screen enables users to specify preferences for Oscillate Mode, Footswitch, Pump Interface, and Language. Selecting the System Information button displays system software versions and the System Reset button.
When in Blade Recall mode, the control unit can be programmed with custom settings for blade forward speed, reverse speed, oscillate speed (Oscillate Mode 1), and oscillate rate (Oscillate Mode 2). If blade settings are changed while the control unit is in Blade Recall, they will be saved until they are changed in Blade Recall or the system is restored to default factory settings (See “Review System Information”). When operating the control unit in Blade Default mode, changes to blade settings will be saved until the control unit is powered down or the system is reset to Blade Recall. Press the Done button to return to the Control screen.
Table 1: Supported Modes of Operation Handpiece
Blade Type
Saved Setting
Long Blades (Straight and Curved) and TURBOWHISKER ™
Oscillate Mode 1 (RPM), Oscillate Mode 2 (RATE)
Curved, HELICUT ™, and ORBIT ™
Oscillate Mode 1 (RPM), Oscillate Mode 2 (RATE)
Straight
Oscillate Mode 1 (RPM), Oscillate Mode 2 (RATE)
Burrs, Long Burrs, BONECUTTER™ Blades
Oscillate Mode 1 (RPM), Oscillate Mode 2 (RATE)
ELITE Burr
Oscillate Mode 1 (RPM), Oscillate Mode 2 (RATE)
Curved
Oscillate Mode 1 (RPM), Oscillate Mode 2 (RATE)
Straight
Oscillate Mode 1 (RPM), Oscillate Mode 2 (RATE)
Burrs and BONECUTTER Blades
Oscillate Mode 1 (RPM), Oscillate Mode 2 (RATE)
DYONICS Mini Motor Drive (REF 7205357)
Burrs and Blades
Oscillate Mode 1 (RPM)
DYONICS POWER Ultralight (REF 7205971)
Ultra Series
Oscillate Mode 1 (RPM)
DYONICS POWER (REF 7205354, 7205355) DYONICS POWERMAX™ (REF 7210542, 7210586, 7209891) DYONICS POWERMAX ELITE (REF 72200616, 72200617, 72200872)
DYONICS POWERMINI™ (REF 72201500, 72201503)
DYONICS™ POWER II Control System
Operations/Service Manual
10600181 Rev. J
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Settings (continued)
Program Blade Settings Press the Settings button to open the Settings screen. To customize and save blade settings, press the Select Blade Recall button on the Settings screen (Figure 8) to set the control unit to the Blade Recall mode. The message in the box above the button changes to read “In Blade Recall” and the selection button name changes to Select Blade Default. Changes made to blade settings while in Blade Recall are saved after the unit is powered down. If the control unit is powered down in Blade Recall, it powers up in Blade Recall, and customized blade settings are retained. The control unit remains in Blade Recall mode until it is reset to Blade Default mode. To change blade settings in Blade Default mode, press the Select Blade Default button on the Settings screen to set the control unit to Blade Default mode. The message box above the button changes to read “In Blade Default” and the selection button name changes to Select Blade Recall. Changes made to blade settings while in Blade Default are not saved after the unit is powered down. If the control unit is powered down in Blade Default, it powers up in Blade Default. Initial blade settings automatically reset to the factory defaults. The control unit remains in Blade Default mode until set to Blade Recall mode.
Oscillate Mode Settings Oscillation can be based on a desired time period (Mode 1) or a set number of revolutions (Mode 2). Table 1 indicates which handpieces support which modes of operation. All DYONICS™ handpieces support Mode 1 operation. Certain newer devices support Mode 2 operation as well. Powered instruments do not support Modes 1 or 2 operation.
Figure 9. Control screen, Port A, Mode 1 speed controls with
Figure 9.
Mode button
Setting Oscillate Mode 1 Oscillate Mode 1 is based on a time interval. The time interval determines the length of time it takes for one forward/reverse period of oscillation. Oscillate Mode 1 defaults to a 0.30 second time interval. The time period can be set from 0.30 to 1.0 seconds, in increments of 0.10 seconds. 1. Press the Settings button to open the Settings screen. 2. Press the Oscillate Mode button to open the Oscillate Mode screen (Figure 10). 3. Select the Port A or Port B controls by pressing the Adjust button under the desired port. The settings change only for the port selected. If settings adjustments for both ports are needed, repeat steps 3 and 4 for each port.
When the control unit is set to either Blade Default or Blade Recall and a handpiece is connected to Port A or Port B, the Control screen displays the speed controls for the oscillation mode last used for that port. The directional arrows above the blue or yellow box switch to Oscillate Mode (Figure 9). Use the Up and Down arrows to set the desired speed. If the handpiece supports both Mode 1 and Mode 2 operation, the Change Mode button is displayed on the Control screen. To view speed controls for the mode not displayed on the Port A or Port B screen, press the Change Mode button for that port (Figure 12).
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Figure 10. Oscillate Mode screen
DYONICS™ POWER II Control System
Operations/Service Manual
Settings (continued)
4. If the device attached to the selected port can be run only in Mode 1, the Oscillate Mode 1 screen opens (Figure 11). This screen displays the length of time it takes for one forward/ reverse period of oscillation. Use the Up and Down arrows to adjust the oscillation period.
5. On the Oscillate Mode 1 screen, use the Up and Down arrows to adjust the oscillation period. The oscillation period can be set from 0.30 to 1.0 seconds, in increments of 0.10 seconds. 6. Press the Set button to save the setting and return to the Oscillate Mode screen. Press the Cancel button to return to the Oscillate Mode screen without saving changes. Press the Restore Default button to restore factory default settings for the attached device.
Setting Oscillate Mode 2 Oscillate Mode 2 is based on the number of revolutions a blade completes before reversing direction. The Oscillate Mode 2 revolutions can be set at 1 or 2 revolutions. Oscillate Mode 2 defaults to 2 revolutions. Figure 11. Oscillate Mode 1 screen
If the device attached to the selected port runs in either Mode 1 or Mode 2, either the Oscillate Mode 1 or the Oscillate Mode 2 screen opens, depending upon which mode was last used for that port. To change from the Oscillate Mode 2 screen to the Oscillate Mode 1 screen: a. Return to the Control screen. b. Press the Mode button at the bottom of the screen (Figure 12). The mode text under the colored box on the Control screen changes to read Mode 1.
1. Press the Settings button on the Control screen (Figure 7) to open the Settings screen. 2. Press the Oscillate Mode button to open the Oscillate Mode screen (Figure 10). 3. Select the Port A or Port B controls by pressing the Adjust button under the appropriate port. The settings change only for the selected port. If settings adjustments for both ports are needed, repeat steps 4 and 5 for each port. 4. If the device attached to the selected port runs in either Mode 1 or Mode 2, either the Oscillate Mode 1 or the Oscillate Mode 2 screen (Figure 13) opens, depending upon which mode was last used for that port.
c. Press the Settings button to return to the Settings screen. d. Press the Oscillate Mode button to return to the Oscillate Mode screen. e. Press the Oscillate Mode Adjust button to access the Oscillate Mode 1 screen.
Figure 13. Oscillate Mode 2 screen
Figure 12.
Mode buttons on the Control screen
DYONICS™ POWER II Control System
Operations/Service Manual
10600181 Rev. J
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Settings (continued)
To change from the Oscillate Mode 1 screen to the Oscillate Mode 2 screen: a. Return to the Control screen (Figure 7). b. Press the appropriate Mode button at the bottom of the screen (Figure 12). The mode text under the colored box on the Control screen changes to read Mode 2. Note: If the device connected does not support Mode 2 operation, the Mode button does not appear on the Control screen.
1. Press the Footswitch button on the Settings screen to open the Footswitch screen (Figure 14). If the control unit detects a DYONICS POWER II Footswitch or Low Profile Variable (“Accelerator”) footswitch, it can operate in either Variable or On/Off mode. If the control unit detects a Low Profile (On/Off), or Pedal-Style footswitch, the Mode buttons will not appear on the screen, and the footswitch will operate in On/Off mode only.
c. Press the Settings button to return to the Settings screen. d. Press the Oscillate Mode button to return to the Oscillate Mode screen. e. Press the Oscillate Mode Adjust button to access the Oscillate Mode 2 screen. 5. On the Oscillate Mode 2 screen, use the Up and Down arrows to adjust the number of revolutions the blade completes in one direction before reversing during oscillation. The number of revolutions per period cannot be set lower than 1 or higher than 2. 6. Press the Set button to save the setting and return to the Oscillate Mode screen. Press the Cancel button to return to the Oscillate Mode screen without saving changes. Press the Restore Default button to restore factory default settings for the attached device.
Program Footswitch Settings The Footswitch screen provides controls for assigning the footswitch to either Port A or Port B, enabling the Hand Control Override feature, setting the footswitch Mode, and changing the forward and reverse pedal assignments.
Figure 14. Footswitch screen for analog footswitch (Mode buttons available)
2. With an analog footswitch such as the DYONICS POWER II Footswitch, or Accelerator Footswitch, use the Mode buttons to select either the On/Off or Variable Mode. The green button indicates the current Mode setting. The On/Off mode button sets the footswitch pedals to digital switch operation. Depressing the pedal causes the handpiece to operate at full set speed. Releasing the pedal turns the handpiece off. The Variable mode button sets the footswitch pedals to adjust the handpiece speed based on pedal pressure.
Note: The footswitch lavage function is available only when the DYONICS™ POWER II Footswitch and the DYONICS 25 Fluid Management System are connected. Note: The footswitch Blade Window Lock function is available only when the DYONICS POWER II Footswitch, low profile footswitch, or accelerator footswitch is connected.
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DYONICS™ POWER II Control System
Operations/Service Manual