Smith & Nephew DYONICS™ POWER II 控制系统操作和维护 PDF

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Operations/Service Manual

Glossary of Symbols

Follow instructions for use Manufacturer Date of manufacture

LINK icon Authorized representative Catalog number


in the European community

CE mark Lot number Serial number

Keep dry Fragile: handle with care This way up

Temperature limitation Humidity limitation TUV certification

Caution Atmospheric pressure limitation Input/output

Consult instructions for use Fuse rating Type B applied part


T 10A 250V H

EU: Not for general waste Equipotentiality USB port

Watertight equipment
per IEC 60529 Up and down buttons Serial interface

On/Off Oscillate footswitch pedal Yes

Forward - clockwise direction of Footswitch window lock No


shaver rotation (distal view)

Reverse - counterclockwise direction


of shaver rotation (distal view)
Footswitch icon L Left footswitch pedal

Oscillate - alternating forward/reverse


direction of shaver rotation
Footswitch icon R Right footswitch pedal

Blade window lock - blade rotation


while setting blade window lock Drill icon Pump icon

Suction on - fluid flow through Saw icon Blade window lock - adjustment
handpiece unrestricted of cutting window stop position

Suction off - fluid flow through Handpiece icon Lavage start/stop


handpiece blocked

Operations/Service Manual   DYONICS™ POWER II Control System 10600181 Rev. M  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. . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Control Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Table of Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Footswitch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Device Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Handpieces and Powered Instruments. . . . . . . . . . . . . . . . . . 28
Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Service Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Replace Rear Panel Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Preventive Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
System Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Peripheral Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Observed Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Handpieces and Powered Instruments. . . . . . . . . . . . . . . . . . . 8 Warning Message Table. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Footswitches. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Warning Message Table. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Unpacking and General Inspection . . . . . . . . . . . . . . . . . . . . . 10 Fault Message Table. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
U.S. Control System (REF 72201030) . . . . . . . . . . . . . . . . . . . . . 10 Technical Specifications*. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
International Control System (Country-specific). . . . . . . . . . . . . 10 Environmental Conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Other Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Factory Defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Recommended System Configuration . . . . . . . . . . . . . . . . . . . 14 Ordering Information/Accessories. . . . . . . . . . . . . . . . . . . . . . 34
Control Unit Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Guidance and Manufacturer’s Declaration . . . . . . . . . . . . . . . 35
Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Electromagnetic Emissions. . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Blade Default Mode versus Blade Recall Mode . . . . . . . . . . . . 18 Guidance for Separation Distances. . . . . . . . . . . . . . . . . . . . . 35
Program Blade Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Program Footswitch Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Special Environment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Setting Pump Interface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Change System Language. . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Service Replacement Units Warranty. . . . . . . . . . . . . . . . . . . . 40
Review System Information . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Service Replacement Program. . . . . . . . . . . . . . . . . . . . . . . . . 40
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Repair Service Program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Device Motor Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Suction Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Blade Selection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

4    10600181 Rev. M DYONICS™ POWER II Control System   Operations/Service Manual


Device Description/Indications for Use/Contraindications

Device Description Intended Use


The Smith & Nephew DYONICS™ POWER II Control System consists The DYONICS POWER II Control System is intended for use when
of a main control unit and a country-specific power cord. A control used with appropriate procedure-specific blades, for resection
system interface cable (optional) and a procedure cart (optional) of soft and osseous tissues including, but not limited to, use in
may also be purchased. large articular cavities, small articular cavities, and for functional
The control system provides for variable speed operation of endoscopic sinus surgery (FESS). The FESS application is limited to
handpieces and powered instruments (i.e., drills, wire/pin small blades that are appropriate for the procedure.
drivers, sagittal saws). The control unit has two instrument ports,
allowing for simultaneous use of two handpieces, two powered Indications for Use
instruments, or a combination of a handpiece and a powered The DYONICS POWER II Control System is indicated for use when
instrument. A footswitch connection port is also available and can used with appropriate procedure-specific blades, for resection
be configured to drive the instrument connected to either Port of soft and osseous tissues including, but not limited to, use in
A or Port B. The control unit displays user prompts and system large articular cavities, small articular cavities, and for functional
diagnostic text. endoscopic sinus surgery (FESS). The FESS application is limited to
The control unit can be used with the following: the Smith & small blades that are appropriate for the procedure.
Nephew DYONICS 25 Fluid Management System. When the
control unit is linked with either pump, the pump outflow regulation Contraindications
occurs, based on whether the blade is in use or idle. Smith & Nephew DYONICS Handpieces and Blades should
A variety of disposable straight and curved surgical blades and not be used with patients exhibiting ankylosis and also lacking
burrs can be inserted into the shaver handpiece for various adequate joint space or distention. Abrasion arthroplasty may not
surgical requirements. Blade action can be controlled by either the be effective in treating heavy patients or those with ankylosis,
handpiece or a footswitch, selecting forward, reverse, or oscillate. instability or expectations beyond the relief of pain.
The control unit provides settings for minimum and maximum Varus or valgus deformity is not itself a contraindication in patients
blade speeds, preprogrammed for each blade type. with a good range of motion and without gross instability or
This operations/service manual provides information about the extreme malalignment (15° varus, 30° valgus).
DYONICS POWER II Control System and its proper use. Intracortical abrasion arthroplasty may be contraindicated in
For information regarding Smith & Nephew DYONICS Handpieces, patients who do not qualify for high tibial osteotomy or total knee
refer to the Instructions for Use (REF 10600266). replacement.
For information regarding Smith & Nephew DYONICS Powered Synovectomy is contraindicated when the disease has progressed
Instruments, refer to the Instructions for Use (REF 10600341). beyond the phase of synovial proliferation and advanced rheumatoid
For information regarding the DYONICS Disposable Endoscopic arthritis, when erosion of the articular cartilage is present.
Blades, refer to the Instructions for Use (REF 1060595). The 2.0 mm and 2.9 mm Smith & Nephew TURBOWHISKER™
For information regarding the DYONICS 25 Fluid Management Blades and 2.9 mm Smith & Nephew Mini Blade Cutter are
System, refer to the operations/service manual (REF 1061600). contraindicated for the FESS application.
For information regarding the LINK, refer to the operations/service The Smith & Nephew POWERMINI™ Blades and all large blades
manual (REF 1060 1432). are contraindicated for the FESS application.
For information regarding the DYONICS POWER II Footswitch,
refer to the instructions for use (REF 10600267).

Operations/Service Manual   DYONICS™ POWER II Control System 10600181 Rev. M  5


Warnings

• The use of accessory equipment not complying with the


Warnings equivalent safety requirements of this equipment may lead
• It is the surgeon’s responsibility to be familiar with the to a reduced level of safety. Consideration relating to the
appropriate surgical techniques prior to use of this device. choice of accessory devices shall include:
• Read these instructions completely prior to use. –– Use of the accessory in the patient vicinity.
• The DYONICS™ 25 Fluid Management System and the –– Evidence that the safety certification of the accessory
LINK can be connected to the DYONICS POWER II Control has been performed in accordance with IEC 60601-1.
System. The use of non-validated peripheral devices may • The use of handpieces and powered instruments, cables,
damage the control unit and create electrical hazards. and other accessories, with this equipment, other than
The use of non-validated peripheral devices will void the those specified or provided by the Smith & Nephew could
warranty. result in increased electromagnetic emissions or decreased
• When connecting peripheral and accessory devices to the electromagnetic immunity and result in improper operation.
DYONICS POWER II Control Unit, use only cables that have • When using a footswitch, ensure that the footswitch is not
been validated for use with the control unit. Non-validated accidentally activated while inserting the blade or burr, or
cables may damage the control unit and create electrical while plugging the connector cable into the control unit.
hazards. The use of non-validated cables will void the • Inadvertently depressing a footswitch while plugging
warranty. in a handpiece or powered instrument will activate the
• Only Smith & Nephew DYONICS Disposable Endoscopic handpiece or powered instrument.
Blades can be used with the DYONICS POWER II Control • Depressing a footswitch will activate the powered
System. instruments even when they are in the “SAFE” position.
• DANGER: Risk of explosion if used in the presence of • Refer to the documentation included with the DYONICS
flammable anesthetics. This device is not suitable for use 25 Fluid Management System LINK for the warnings and
in the presence of a flammable anesthetic mixture with air, precautions associated with those devices.
oxygen, or nitrous oxide.
• Refer to the Smith & Nephew DYONICS Handpieces
• To avoid patient burns, do not place the handpiece on the Instructions for Use (REF 10600266) for the warnings
patient when the handpiece is not in use. and precautions associated with the handpieces.
• High voltage (1500 VAC) is present during dielectric • Refer to the Smith & Nephew DYONICS Powered Instruments
strength testing. Exercise extreme caution while operating Instructions for Use (REF 10600341) for the warnings and
the dielectric strength tester to prevent personal injury precautions associated with the powered instruments.
from electrical shock or damage to the equipment. Ensure
• Refer to the Smith & Nephew DYONICS Disposable
that only authorized personnel are in the test area during
Endoscopic Blades Instructions for Use (REF 1060595) for
testing. Ensure that the cover is on the DYONICS POWER II
the warnings and precautions associated with the blades
Control Unit before beginning the tests.
• Electrical Interference. This equipment is designed to be
• Check that the electrical equipment is properly grounded
used as a stand-alone, in proximity too, or in a stacked
(i.e., plugs contain a ground prong). Grounding reliability
configuration with other medical equipment. Although
can be achieved only when the control unit is connected to
this equipment is designed and tested to minimize
an equivalent AC power receptacle marked “hospital only”
interference with, or by, other electrical equipment;
or “hospital-grade.”
interference may occur.
• Dangerous voltages are present during leakage current
If interference occurs with other equipment it may be
testing. Do not touch the control unit while power is applied.
corrected by one or more of the following measures:
• Do not use this device in oxygen rich environments (>25%).
–– Reorient or relocate this equipment, the other
• If this unit is configured as part of a system, the entire equipment, or both.
system should be tested for compliance with IEC 60601-1.
–– Increase the separation between the pieces of
• If the leakage current of the configured system exceeds the equipment.
limits of IEC 60601-1, install an appropriately rated
–– Connect the pieces of equipment into different outlets
IEC 60601-1 approved isolation transformer and retest
or circuits.
the system.
–– Consult a biomedical engineer.

6    10600181 Rev. M DYONICS™ POWER II Control System   Operations/Service Manual


Precautions

• Abnormal performance, due to Electromagnetic • Environmental Protection: This equipment contains electronic
Disturbances, may be manifested by a failure to properly printed circuit assemblies. At the end of the useful life of the
maintain the speed of operation of the hand pieces and equipment it should be disposed of in accordance with any
powered instruments. applicable national or institutional policy relating to obsolete
If abnormal performance is observed, it may be corrected electronic equipment.
by one or more of the following measures. • Do not connect any equipment to the serial port unless it was
–– Reorient or relocate this equipment, the other designed by Smith & Nephew to communicate with the control
equipment, or both. unit via this port.
–– Increase the separation between the pieces of • Check the Control screen to ensure that the proper settings are
equipment. displayed prior to beginning any procedure.
–– Connect the pieces of equipment into different outlets • Electrical safety testing should be performed by a biomedical
or circuits. engineer or other qualified person.
–– Consult a biomedical engineer. • Excessive risk (leakage current) may result if this equipment
is connected to a power distribution system other than the
• High Frequency (HF) Interference: This equipment was manufacturer’s recommended power distribution system.
designed and tested to be used with HF Electrical Surgical
Unit (ESU) equipment. • This device has been tested and verified to comply with
IEC 60601-1-2. This exceeds the requirements specified by FCC
If interference occurs with other equipment it may be Part 18 for ISM equipment. This device is intended for operation
corrected by one or more of the following measures: in a medical facility only. Usage in a residential environment will
–– Reorient or relocate this equipment, the other likely cause unacceptable RF interference for which the user is
equipment, or both. held responsible.
–– Increase the separation between the pieces of • Handle the unit with care. If the unit is dropped or damaged
equipment. in any way, it must be returned immediately for service.
–– Connect the pieces of equipment into different outlets • Use only one finger at a time when operating the LCD touch
or circuits. screen. Multiple, simultaneous finger presses can result in
–– Consult a biomedical engineer. unintended changes to settings and erroneous control inputs.
• Press the Power Up/Power Down button to turn off the control
Precautions system. Failure to do so may result in lost custom settings.
U.S. Federal law restricts this device to sale by or on the order • Inspect all components regularly for wear. Pay particular
of a physician. attention to potential damage to insulation, especially with
• Prior to each use, inspect the device to ensure it is functioning universal extension cables.
properly and not damaged. Do not use a damaged device. • Do not sterilize or immerse the control unit in disinfectant.
• 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.

Operations/Service Manual   DYONICS™ POWER II Control System 10600181 Rev. M  7


System Components/Peripheral Devices

System Components A footswitch is required when using the POWERMAX™ ELITE


Handpiece (REF 72200617), the POWERMINI™ Handpiece
The DYONICS™ POWER II Control Unit includes a Power Up/Power (REF 72201503) the Ultralight shaver handpiece (REF 7205971), or the
Down button, an LCD screen, two connection ports for handpieces Mini Motor Drive Handpiece (REF 7205357). A footswitch also may be
or powered instruments, a footswitch connection port, and rear used with the hand-control handpieces and powered instruments.
panel connections for a variety of peripheral devices.
The control unit’s LCD screen displays all of the controls needed DYONICS POWER II Footswitch (REF 72201092)
to set up and operate the control unit, including adjusting settings, This footswitch communicates switch and pedal action to the
adjusting set speed, selecting oscillation modes, operating control unit. It also supports the DYONICS 25 Fluid Management
window lock, saving settings, and restoring settings System’s lavage function and the blade window lock function. The
to system defaults. footswitch operation can be modified using the Footswitch settings
The control system has been designed to meet IEC 60601-1 screen. Two modes are available: On/Off and Variable. Refer to
safety and performance standards for medical equipment. the “Settings” section of this manual for more information.
The CE mark on the control unit signifies compliance with The footswitch has three control pedals and two switches. The
Medical Directive 93/42/EEC. pedals are labeled L, R, and <>. The L and R pedals default to
reverse and forward, respectively. Depressing the left or right pedal
Peripheral Devices causes the control unit to supply power to the handpiece to drive
the blade in the direction indicated. The left and right pedals can
Handpieces and Powered Instruments be configured to run either forward or reverse. The center (<>)
A variety of DYONICS handpieces and powered instruments pedal is always oscillate.
can be used with the control unit. All handpieces and powered The two switches provide control for the blade window lock
instruments can be connected to either the A or B connection function and the DYONICS 25 Fluid Management System’s lavage
port on the control unit front panel (Figure 1). The control function. The footswitch plugs into the footswitch connection port
unit automatically detects the type of handpiece or powered located on the front panel of the control unit (Figure 1).
instrument connected. Note: The footswitch does not control the Forward or Reverse
For information regarding handpieces and powered instruments Speed Shift settings. The <> (Oscillate) pedal causes the control
that may be used with the control unit, refer to the DYONICS unit to send alternate forward and reverse commands to the
Handpieces Instructions for Use or the DYONICS Powered handpiece. The control unit continues the alternating signals until
Instruments Instructions for Use. Handpieces and powered the foot is removed from the <> pedal.
instruments are sold separately from the control unit. For more information regarding the DYONICS POWER II Footswitch,
refer to the instructions for use.
Footswitches For information regarding the DYONICS 25 Fluid Management
The control unit can use a wired footswitch to control blade System, refer to the instructions for use.
action. Typical footswitches control forward, reverse, oscillate,
and window lock modes of operation.

8    10600181 Rev. M DYONICS™ POWER II Control System   Operations/Service Manual


Peripheral Devices

DYONICS™ Low Profile Footswitch (REF 7205399) Smith & Nephew Shaver Interface Cables (optional)
The low profile footswitch has three control buttons and The DYONICS POWER II Control System is designed for use with
a Window Lock button. The control buttons are labeled the DYONICS 25 Fluid Management System to offer automatic
FORWARD, REVERSE, and OSCILLATE. Pressing a footswitch suction control. The DYONICS 25 Shaver Interface Cable
button signals the control unit to accelerate the blade until it (REF 91000973) connects the DYONICS POWER II Control Unit to
reaches the set speed. Set speed is then maintained until the the DYONICS 25 System Control Unit.
button is released. The buttons on the low profile footswitch Note: The correct cable must be connected if the DYONICS 25
are not throttles. They simply turn the handpiece on or off in Control Unit automatic suction control feature is to be used.
the specified direction.
Smith & Nephew LINK - DYONICS POWER II
DYONICS Low Profile Variable (Accelerator)
The LINK – DYONICS POWER II (REF 72205189) enables the
Footswitch (REF 7205397) DYONICS POWER II to communicate with approved Smith &
The low profile variable footswitch allows the FORWARD, Nephew devices on the LINK Connect Network.
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.

Operations/Service Manual   DYONICS™ POWER II Control System 10600181 Rev. M  9


Unpacking and General Inspection

Unpacking and General Inspection International Control System


Carefully unpack and inspect all components shipped with (Country-specific)
the Smith & Nephew DYONICS™ POWER II Control System. Each international Smith & Nephew DYONICS POWER II Control
If any parts are missing or damaged, contact your authorized System contains the following:
Smith & Nephew representative. Save the carton and packing
1 ea Smith & Nephew DYONICS POWER II Control Unit
materials in the event a component must be returned for repair.
(REF 72200873)
The following parts should have been received:
1 ea Smith & Nephew DYONICS 25 Shaver Interface Cable
U.S. Control System (REF 72201030) (REF 91000973)
1 ea Smith & Nephew DYONICS POWER II Control Unit 1 ea Hospital-grade power cord, country-specific
(REF 72200873) 1 ea Smith & Nephew DYONICS POWER II Control System
1 ea Smith & Nephew DYONICS 25 Shaver Interface Cable Operations/Service Manual, country-specific version
(REF 91000973) (REF 10600181)
1 ea Hospital-grade power cord (REF 605-0004) 1 ea Smith & Nephew DYONICS Handpieces Instructions for Use,
country-specific version (REF 10600266)
1 ea Smith & Nephew DYONICS POWER II Control System
Operations/Service Manual (REF 10600181) 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)

10    10600181 Rev. M 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.

Operations/Service Manual   DYONICS™ POWER II Control System 10600181 Rev. M  11


Rear Panel Layout

85002481 Rev. E 06/2019

Figure 2.  DYONICS™ POWER II Control Unit Rear Panel (Connectors shown with covers removed) for units with serial numbers AAX-5001 or greater)

Controls/Connections Function
1 Bidirectional Port 1 Serial communication connection to the LINK.
2 Bidirectional Port 2 Serial communication connection to the DYONICS 25 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.
Equipotential Compensator
6 Used to bring other equipment into the same case potential as the device.
Terminal (case ground)
This receptacle is an integral part of the power input module and accommodates
7 Power Cord Connector
the hospital grade power cord accessory.

12    10600181 Rev. M DYONICS™ POWER II Control System   Operations/Service Manual


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 Fault Messages


When the system encounters a system fault, it stops all shaver
Warning Messages operation, sounds an alarm, clears the current screen, and
If the control unit detects a problem, it displays a yellow warning displays the fault message. A complete list of fault messages is
message box at the bottom of the Port window (Figure 4). listed in the Fault Message Table.
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.
A complete list of warning messages is listed in the Warning
Message Table.

Figure 4.  Warning message

Operations/Service Manual   DYONICS™ POWER II Control System 10600181 Rev. M  13


Recommended System Configuration

Recommended System Configuration • The use of accessory equipment not complying with the
equivalent safety requirements of this equipment may lead to a
Figure 5 indicates a system configuration that complies with reduced level of safety. Consideration relating to the choice of
IEC 60601-1 requirements. accessory devices shall include:
WARNING: If this unit is configured as part of a –– Use of the accessory in the patient vicinity.
system, the entire system should be tested for
compliance with IEC 60601-1. –– Evidence that the safety certification of the accessory has
been performed in accordance with the appropriate 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.

Wired/Wireless Remote Control

Smith & Nephew


DYONICS™ 25 Fluid Management System VAC
Control Unit
REF 7211010

RF Handpiece
Wall receptacle
100-240 VAC
Smith & Nephew VULCAN™ Generator VAC 15 A
REF 7210812 50/60Hz

Footswitch

Handpiece or Handpiece or
Powered Instrument Powered Instrument

Wall receptacle
DYONICS POWER II Shaver System VAC 100-240 VAC
REF 72200873 15 A
50/60Hz
Shaver
Connection
Port Footswitch

Figure 5.  Recommended configuration for DYONICS™ POWER II Control System

14    10600181 Rev. M DYONICS™ POWER II Control System   Operations/Service Manual


Control Unit Setup

Control Unit Setup 3. The system will briefly display the Smith & Nephew splash
screen (Figure 6) before displaying the Control screen
WARNING: The DYONICS™ 25 and the LINK can be (Figure 7). The Control screen displays connected devices
connected to the DYONICS POWER II Control System. and their status in the Port A and Port B windows. The icon
The use of non-validated peripheral devices may damage the bar across the top of the Control screen displays icons for the
control unit and create electrical hazards. The use of pump status, footswitch status, and type of device connected.
non-validated peripheral devices will void the warranty.
4. Connect the device cable to the desired device connection
WARNING: When connecting peripheral and accessory port. A single device can be connected to either Port A
devices to the DYONICS POWER II Control Unit, use or Port B, or two devices can be connected to Port A and
only cables that have been validated for use with the control Port B respectively. Each port will accept a handpiece, drill,
unit. Non-validated cables may damage the control unit and or saw. Devices connected to Port A and Port B can be used
create electrical hazards. The use of non-validated cables will simultaneously.
void the warranty.
WARNING: Inadvertently depressing a footswitch
CAUTION: Use only one finger at a time when operating the LCD while plugging in a handpiece or powered instrument
touch screen. Multiple, simultaneous finger presses can result in will activate the handpiece or powered instrument.
unintended changes to settings and erroneous control inputs.
WARNING: Depressing a footswitch will activate the
CAUTION: To prevent damage to the control unit connector powered instruments even when they are in the
ports, do not plug in wet. Ensure that cleaned or sterilized cable “SAFE” position.
connectors are completely dry prior to connecting to the control
unit, handpiece or powered instrument. Note: Avoid pressing the trigger, throttle lever, or hand controls
while attaching the instrument cable. If this occurs, the
1. Plug the control unit power cord into the rear panel power cord instrument will not run until the trigger, throttle lever, or button
connection port and a grounded AC power source. is released for one second and then activated.
Note: Accessory devices such as handpieces, drills, pumps, Note: The system automatically recognizes which type of
etc. may be plugged into the front and rear panels either before device is connected to each port.
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

Operations/Service Manual   DYONICS™ POWER II Control System 10600181 Rev. M  15


Control Unit Setup

Note: When a handpiece is connected to the control unit for 5. Press the Forward button for the device attached to Port A to
the first time, the Control screen will display the speed controls confirm operation. Press the Forward button for the device
for Oscillate Mode 1 for that port. Refer to the “Settings” section attached to Port B to confirm operation. If a device does not
of this manual for more information. have a Forward button, press the equivalent (i.e., the trigger on
–– Push-on connectors: Handpiece cable connectors have a a drill, a footswitch pedal) to confirm that device’s operation.
locking sleeve, which holds a protective cap. Pull the sleeve –– When confirming operation, directional arrows immediately
back to remove the cap. Orient the cable connector plug by above the colored boxes animate and turn green. The
aligning the red dots on the plug and the panel. Push the directional arrows indicate forward rotation (>>). If the
plug into the connection port and release the locking sleeve. attached device does not specify forward operation, the
The cable is fully engaged when the red dots are aligned. direction of the arrows is determined by that device.
Check the Control screen (Figure 7) to confirm connections and –– The handpiece motor action can be observed inside the
device recognition. The icon for the device connected to Port A distal end of the handpiece.
appears in the icon bar above the Port A window on the left side 6. Verify Reverse (<<) and Oscillate (<<>>) modes. The
of the screen. Icons associated with Port A appear in blue. 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
Figure 7.  Control screen by default. The footswitch can be set to control the device
connected to Port B. Refer to the “Settings” section of this
The icon for the device connected to Port B appears in the icon manual for information on adjusting the footswitch settings.
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 8. Repeat Steps 5 and 6 for the footswitch controls to confirm
device connected to a port, the corresponding port window proper operation of the footswitch-controlled device.
displays a connector icon. 9. Optional: Connect the suction by sliding the suction tubing
onto the outflow portal on the proximal end of the handpiece.
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.

16    10600181 Rev. M DYONICS™ POWER II Control System   Operations/Service Manual


Control Unit Setup

Control Unit Integration 3. Connect the shaver interface cable to the fluid management
If the DYONICS™ POWER II Control Unit is connected to a system control unit.
DYONICS 25 Fluid Management System, a pump icon is a. For the DYONICS 25 Control Unit, connect the cable to the
displayed automatically in the icon bar above the Port A window. shaver port on the rear panel of the control unit.
The pump defaults to the Port A device. The pump can be set to 4. Set the suction lever on the handpiece to the MAX (fully
integrate with the Port B device by selecting the Port B button on open) position.
the Pump Interface screen located in Settings.
5. Set the shaver suction settings.
Note: A connected pump integrated with Port A responds to
commands only from the device and footswitch connected to Port A. a. The DYONICS 25 Control Unit shaver suction settings are
A connected pump integrated with Port B responds to commands factory preset to 100% outflow while the handpiece is on
only from the device and footswitch connected to Port B. and to 50% outflow when the handpiece is idle. Refer to the
“Inflow/Outflow Tube Set, Shaver Detected Mode” section of
Notes: the DYONICS 25 Control Unit Operations/Service Manual for
• The DYONICS POWER II Footswitch lavage start/stop button more information.
works only when the footswitch and pump are assigned to the Note: To adjust the DYONICS 25 Control Unit custom shaver
same port. suction levels, refer to the “Settings” section of the DYONICS
• The DYONICS POWER II Footswitch lavage start/stop button 25 Control Unit Operations/Service Manual for instructions.
works only with the DYONICS 25 pump. To integrate the DYONICS POWER II Control Unit with a LINK;
• The pump icon on the Control screen animates only when the 1. Ensure the LINK was installed per the LINK MNL (REF 10601432).
control unit is connected to the DYONICS 25 Pump and the
pump is pumping. 2. Ensure the communications cable is connected into the
bidirectional port 1 (Figure 2) on the rear panel of the DYONICS
To integrate the DYONICS POWER II Control Unit with a DYONICS POWER II Control Unit.
25 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.
2. Ensure that the communications cable is connected into
bidirectional port 2 (Figure 2) 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.
a. Use the DYONICS 25 Shaver Interface Cable to connect
the DYONICS POWER II Control Unit to the DYONICS 25
Control Unit.

Operations/Service Manual   DYONICS™ POWER II Control System 10600181 Rev. M  17


Settings

Settings The Settings screen enables users to select the blade mode using
the Select Blade Default button or the Select Blade Recall button.
CAUTION: Use only one finger at a time when operating the LCD Footswitch, Pump Interface, and Language settings are automatically
touch screen. Multiple simultaneous finger presses can result in saved between each power down and power up. Blade settings are
unintended changes to settings and erroneous control inputs. saved only when the control unit is set in Blade Recall mode.
Once all handpieces and other devices to be used during the The Blade Reset function appears on the Settings screen only if
procedure have been connected to the control unit and system a handpiece is connected to either Port A or Port B. The Blade
operation has been verified, press the Settings button at the Reset buttons reset the blade connected to the selected port
bottom of the Control screen to view the Settings screen to the factory default settings. Blade Reset does not change the
(Figure 8). The Settings button is active whenever the oscillation mode previously selected for that port.
handpieces and powered instruments are not running. 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.
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
Figure 8.  Settings screen
Blade Recall, they will be saved until they are changed in Blade
Recall or the system is restored to default factory settings (See
The Settings screen enables users to specify preferences for “Review System Information”).
Oscillate Mode, Footswitch, Pump Interface, and Language.
When operating the control unit in Blade Default mode, changes
Selecting the System Information button displays system to blade settings will be saved until the control unit is powered
software versions and the System Reset button. down or the system is reset to Blade Recall.
Press the Done button to return to the Control screen.

Supported Modes of Operation


Handpiece Maximum (Speed) RPM Saved Setting
DYONICS POWERMAX™ ELITE 3000 Oscillate Mode 1 (RPM), Oscillate Mode 2 (RATE)
(REF 72200616, 72200617, 72200872)
5000 Oscillate Mode 1 (RPM), Oscillate Mode 2 (RATE)
8000 Oscillate Mode 1 (RPM), Oscillate Mode 2 (RATE)

10000 Oscillate Mode 1 (RPM), Oscillate Mode 2 (RATE)


DYONICS POWERMINI™ 3000 Oscillate Mode 1 (RPM), Oscillate Mode 2 (RATE)
(REF 72201500, 72201503)
5000 Oscillate Mode 1 (RPM), Oscillate Mode 2 (RATE)

6000 Oscillate Mode 1 (RPM), Oscillate Mode 2 (RATE)


DYONICS POWER Ultralight (REF 7205971) 5000 Oscillate Mode 1 (RPM)
DYONICS Mini Motor Drive (REF 7205357) 3500 Oscillate Mode 1 (RPM)

Table 1.  Supported Modes of Operation

18    10600181 Rev. M DYONICS™ POWER II Control System   Operations/Service Manual


Settings

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 9) 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.
Figure 9.  Control screen, Port A, Mode 1 speed control.
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 Setting Oscillate Mode 1
changes to read “In Blade Default” and the selection button name Oscillate Mode 1 is based on a time interval. The time interval
changes to Select Blade Recall. Changes made to blade settings determines the length of time it takes for one forward/reverse
while in Blade Default are not saved after the unit is powered period of oscillation. Oscillate Mode 1 defaults to a 0.30 second
down. If the control unit is powered down in Blade Default, it time interval. The time period can be set from 0.30 to 1.0 seconds,
powers up in Blade Default. Initial blade settings automatically in increments of 0.10 seconds.
reset to the factory defaults. The control unit remains in Blade
1. Press the Settings button to open the Settings screen.
Default mode until set to Blade Recall mode.
2. Press the Oscillate Mode button to open the Oscillate Mode
Oscillate Mode Settings screen (Figure 10).
Oscillation can be based on a desired time period (Mode 1) or 3. Select the Port A or Port B controls by pressing the Adjust
a set number of revolutions (Mode 2). Table 1 indicates which button under the desired port. The settings change only for
handpieces support which modes of operation. the port selected. If settings adjustments for both ports are
All DYONICS™ handpieces support Mode 1 operation. Certain needed, repeat steps 3 and 4 for each port.
newer devices support Mode 2 operation as well. Powered
instruments do not support Modes 1 or 2 operation.
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 (Figure 10) 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 10).
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).
Figure 10.  Oscillate Mode screen

Operations/Service Manual   DYONICS™ POWER II Control System 10600181 Rev. M  19


Settings

4. If the device attached to the selected port can be run only in 5. On the Oscillate Mode 1 screen, use the Up and Down arrows
Mode 1, the Oscillate Mode 1 screen opens (Figure 11). This to adjust the oscillation period. The oscillation period can be
screen displays the length of time it takes for one forward/ set from 0.30 to 1.0 seconds, in increments of 0.10 seconds.
reverse period of oscillation. Use the Up and Down arrows to 6. Press the Set button to save the setting and return to the
adjust the oscillation period. 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.
1. Press the Settings button on the Control screen (Figure 7) to
open the Settings screen.
Figure 11.  Oscillate Mode 1 screen
2. Press the Oscillate Mode button to open the Oscillate Mode
If the device attached to the selected port runs in either screen (Figure 10).
Mode 1 or Mode 2, either the Oscillate Mode 1 or the
3. Select the Port A or Port B controls by pressing the Adjust
Oscillate Mode 2 screen opens, depending upon which mode
button under the appropriate port. The settings change only
was last used for that port.
for the selected port. If settings adjustments for both ports are
To change from the Oscillate Mode 2 screen to the Oscillate needed, repeat steps 4 and 5 for each port.
Mode 1 screen:
4. If the device attached to the selected port runs in either Mode 1
a. Return to the Control screen. or Mode 2, either the Oscillate Mode 1 or the Oscillate Mode
b. Press the Mode button at the bottom of the screen 2 screen (Figure 13) opens, depending upon which mode was
(Figure 12). The mode text under the colored box on the last used for that port.
Control screen changes to read Mode 1.
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

20    10600181 Rev. M DYONICS™ POWER II Control System   Operations/Service Manual


Settings

To change from the Oscillate Mode 1 screen to the Oscillate 1. Press the Footswitch button on the Settings screen to open
Mode 2 screen: the Footswitch screen (Figure 14). If the control unit detects
a. Return to the Control screen (Figure 7). a DYONICS POWER II Footswitch or Low Profile Variable
(“Accelerator”) footswitch, it can operate in either Variable or
b. Press the appropriate Mode button at the bottom of the On/Off mode. If the control unit detects a Low Profile (On/
screen (Figure 12). The mode text under the colored box on Off), or Pedal-Style footswitch, the Mode buttons will not
the Control screen changes to read Mode 2. appear on the screen, and the footswitch will operate in On/
Note: If the device connected does not support Mode Off mode only.
2 operation, the Mode button does not appear on the
Control screen.
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. Figure 14.  Footswitch screen for analog footswitch
(Mode buttons available)
6. Press the Set button to save the setting and return to the
Oscillate Mode screen. Press the Cancel button to return to 2. With an analog footswitch such as the DYONICS POWER II
the Oscillate Mode screen without saving changes. Press the Footswitch, or Accelerator Footswitch, use the Mode buttons to
Restore Default button to restore factory default settings for select either the On/Off or Variable Mode. The green button
the attached device. indicates the current Mode setting.
The On/Off mode button sets the footswitch pedals to digital
Program Footswitch Settings switch operation. Depressing the pedal causes the handpiece
The Footswitch screen provides controls for assigning the to operate at full set speed. Releasing the pedal turns the
footswitch to either Port A or Port B, enabling the Hand Control handpiece off.
Override feature, setting the footswitch Mode, and changing the The Variable mode button sets the footswitch pedals to adjust
forward and reverse pedal assignments. the handpiece speed based on pedal pressure.
Note: The footswitch lavage function is available only when 3. Use the Port Control buttons to assign the footswitch to a
the DYONICS™ POWER II Footswitch and the DYONICS 25 Fluid preferred port. Press the Port A or Port B button to assign the
Management System are connected. footswitch to either Port A or Port B. The green button indicates
Note: The footswitch Blade Window Lock function is available only the current Port Control setting. The footswitch drives the
when the DYONICS POWER II Footswitch, low profile footswitch, or device connected to the selected port.
accelerator footswitch is connected.

Operations/Service Manual   DYONICS™ POWER II Control System 10600181 Rev. M  21


Settings

4. Use the Hand Control Override buttons to set the primary Setting Pump Interface
controls for a connected device. The green button indicates the
Press the Pump Interface button on the Settings screen to
current Hand Control Override setting.
open the Pump Interface screen (Figure 15). The pump interface
When the Hand Control Override is set to On, only the operates only for the handpiece connected to the port to which
footswitch operates the handpiece. The hand controls for that the pump is assigned. For example, Port A must be selected in
handpiece do not operate. the Port Control box for the pump to work with the handpiece
When the Hand Control Override is set to Off, either the hand connected to Port A.
controls or the footswitch can be used to operate the device.
However, only one source of control can be used at one time.
The handpiece controls and the footswitch cannot be used
simultaneously.
5. Use the Forward buttons to assign forward action to the left or
right pedal on the DYONICS ™ POWER II Footswitch. The Forward
option appears only when the system detects the footswitch.
6. Press Set to save the footswitch settings and return to the
Settings screen. Press Cancel to return to the Settings screen
without saving any changes.
Figure 15.  Pump Interface screen
1. Press the Pump Interface button on the Settings screen to
open the Pump Interface screen.
2. Press the Port A button in the Port Control box to assign the
pump interface to Port A. Press the Port B button in the Port
Control box to assign the pump interface to Port B. The green
button indicates the Pump Interface setting.
3. Press Set to save the Pump Interface setting to memory and
return to the Settings screen. Press the Cancel button to return
to the Settings screen without making any changes.

22    10600181 Rev. M DYONICS™ POWER II Control System   Operations/Service Manual


Settings

Change System Language Review System Information


Press the Settings button to open the Settings screen. Press Press the Settings button on the Control screen to open the
the Language button to open the Language screen (Figure 16). Settings screen. Press the System Information button to
open the System Information screen (Figure 18). The System
Information screen displays the product name, product reference
number, software version, application version, and motor controller
version. If a DYONICS™ POWER II Footswitch is connected to the
control unit, this screen displays the footswitch software version. If
the DYONICS POWERMINI™ Handpiece is connected to the control
unit, this screen displays the handpiece software version.
Press the System Reset button to reset all system settings,
including blade settings, to the original factory default settings.
The selected language does not change. When the System Reset
button is pressed, a confirmation screen asking “Are you sure you
Figure 16.  Language screen want to reset all saved settings?” is displayed (Figure 19). Press
Yes to return the system to the factory default settings. Press No
Select the desired language by pressing the corresponding button.
to return to the System Information screen without making any
The control unit displays a confirmation message “Are you sure that
changes. Refer to the “Technical Specifications” section of this
you want to change the displayed language to {selected language}?”
manual for system default settings.
in that language (Figure 17). Press the button to confirm and
change the control unit language. To cancel and leave the control Note: Applies to system Serial Numbers above 5001.
unit language unchanged, press the x button. Press the Done
button to return to the Settings screen.

Figure 18.  System Information screen

Figure 17.  Language Selection pop-up

Figure 19.  System Reset prompt

Operations/Service Manual   DYONICS™ POWER II Control System 10600181 Rev. M  23


Operation

Operation To activate a no-hand controls handpiece, ensure that the footswitch


is assigned to the same port as the handpiece. If a handpiece
CAUTION: Use only one finger at a time when operating the LCD without hand controls is connected to a port without a footswitch
touch screen. Multiple, simultaneous finger presses can result in assigned, a warning message is displayed on the screen for that
unintended changes to settings and erroneous control inputs. port. The message disappears when a footswitch is connected.
Adjustable speed control buttons for the handpiece connected to The button or pedal controls on the footswitch allow selection of
Port A appear below the blue box on the left side of the screen. three cutting actions: Forward, Reverse, and Oscillate.
The blue box color corresponds to the blue ring on the Port A
connector. During operation, use these Up and Down buttons to Note: On the three-pedal footswitches, if the Forward and
adjust handpiece speed. Changes take effect immediately. If no Oscillate pedals are depressed simultaneously, the Oscillate pedal
device is connected to Port A, a cable connector icon is displayed takes priority. If the Reverse and Oscillate pedals are depressed
in the blue box. simultaneously, the Oscillate pedal takes priority.
Adjustable speed controls for the handpiece connected to Port B DYONICS™ POWER II Footswitch and DYONICS POWER Low
appear in the yellow box on the right side of the screen. The yellow Profile Variable (Accelerator) Footswitch
box color corresponds to the yellow ring on the Port B connector.
The Smith & Nephew DYONICS POWER II Footswitch and DYONICS
During operation, use these Up and Down buttons to adjust
POWER low profile variable footswitch operation can be modified
handpiece speed. Changes take effect immediately. If no device
using the Footswitch screen. Refer to the “Footswitch Settings”
is connected to Port B, a cable connector icon is displayed in the
section of this manual for more information.
yellow box.
The left, right and oscillate pedals each vary set speed between
Device Motor Control 0–100%, depending upon the pressure applied to the pedal.
Maximum pressure provides 100% of set speed. Zero pressure
Device motors can be operated using either the device controls or
stops the device.
footswitch controls. A device with hand controls allows the surgeon
to control shaver operation without the need for a footswitch. In addition, the DYONICS POWER II Footswitch provides button
controls for lavage and blade window lock. For more information
To activate the handpiece using the hand controls, press and
regarding the DYONICS POWER II Footswitch, refer to the
release the Forward, Reverse or Oscillate button. The device
Instructions for Use for that product.
operates in the selected mode until any button is pressed and
released again, which stops the motor. Press and release the With the accelerator footswitch, the blade accelerates in the
desired button to restart or change direction. selected direction until it reaches set speed for the blade type.
Speed can be decreased or increased by varying the pressure
Note: If a footswitch is assigned to the same port as the
applied to the footswitch controls. Speed range is determined
handpiece, ensure that the hand control override setting
by how far the pedal is depressed. 100% of speed is set at the
on the Footswitch screen is set to Off.
maximum point of depression. The range is reset each time the
pedal is released completely and then depressed again.

24    10600181 Rev. M DYONICS™ POWER II Control System   Operations/Service Manual


Operation

DYONICS™ Low Profile Footswitch Tissue-cutting performance has been determined at various
With the standard low profile footswitch, the blade rotates in the speeds for each blade. This information indicates that Oscillate
direction specified, accelerates to the set speed, and continues at mode is more efficient for cutting soft tissue (Figure 20), while
that speed until the footswitch button is released. Forward mode is more efficient for cutting hard, osseous tissue
(Figure 21).
DYONICS Pedal-Style Footswitch Note: The Ultra Series curved blades and the Ultra Series
With the pedal-style footswitch, depressing the FORWARD TURBOWHISKER ™ Blades may be used in all Smith & Nephew
or REVERSE pedal starts the handpiece. Releasing the pedal handpieces, with the exception of the DYONICS POWERMINI ™
stops the handpiece. Press the FORWARD and REVERSE pedals Handpiece and the DYONICS Mini Motor Drive.
simultaneously for Oscillate mode. Note: Standard curved blades and the standard TURBOWHISKER
blade do not fit DYONICS Ultralight Handpieces.
Suction Control Note: DYONICS POWERMINI Blades can only be used with the
The suction flow control lever on the distal end of the handpiece DYONICS POWERMINI Handpieces.
enables manual suction control. The lever can be set anywhere
Note: The DYONICS Mini Blades can only be used with the
between the fully open and fully closed positions. For more
DYONICS Mini Motor Drive.
information about shaver handpieces, refer to the Smith & Nephew
DYONICS Handpieces Instructions for Use. Blade Window Lock
Blade window lock sets the stop position of the inner blade relative
Blade Selection to the opening at the top of the outer blade. Press and hold the
WARNING: Only Smith & Nephew DYONICS Disposable Window Lock button on the footswitch to rotate the blade. When
Endoscopic Blades can be used with the DYONICS the blade is in the best stopping position for the procedure,
POWER II Control System. release the Window Lock button.
All DYONICS Disposable Endoscopic Blades have been Blade window lock also may be set by pressing and holding the
extensively tested for safety and performance. Based on <> (Oscillate) button on the hand-control handpieces for one
these tests, shaver blade speed ranges have been preset in second, or by pressing and holding the Window Lock button on
the control unit, refer to Table 2 Programmed Blade Speeds. the Control screen.

Operations/Service Manual   DYONICS™ POWER II Control System 10600181 Rev. M  25


Operation

Cutting Medium - Cutting Medium -


Synovial Tissue Bovine Bone

e
illat

TISSUE CUTTING RATE


TISSUE CUTTING RATE

Osc
ard
Forw
illate
Osc
Forward

BLADE SPEED BLADE SPEED


Figure 20.  Cutting efficiency with soft tissue Figure 21.  Cutting efficiency with osseous tissue

Blade Speed Forward/Reverse Speed Shift


When the control unit is turned on, it provides the factory default Depress and hold the Forward or Reverse button on the handpiece
blade speeds for Blade Default mode for all blade types (blade for one second to alternate between the two preset speeds (high
types are not recognized by the mini or ultralight handpieces). and low) in the forward or reverse direction. Use the Up and Down
As blades and set speeds are changed, the system stores the buttons on the Control screen to adjust the high and low speeds.
latest speed set for each blade type. Blade speed changes made The high speed setting can be adjusted only when the control unit
while the system is in Blade Default mode are not saved after the is in high speed mode. The low speed setting can be adjusted
system is powered down. only when the control unit is in low speed mode. If the high and
When no blade is installed in the selected handpiece, the control low speeds are not preset, then Speed Shift does not activate.
unit displays the default speed range and set speeds for straight Note: Speed shift is not applicable in oscillate mode and does not
blades, refer to Table 2 Programmed Blade Speeds. work through any footswitch.
Note: All blade speeds can be set in increments of 100 rpm in
Forward/Reverse mode. Oscillate Mode 1 speed can be set
in increments of 100 rpm, and Oscillate Mode 2 can be set in
increments of 1 unit of rate.

Blade Family Recall


Blade family recall remembers the last speed settings in forward,
reverse, or oscillate mode used during the procedure. The system
must be in Blade Recall to save settings after the system is
powered down.
Note: The mini motor drive and ultralight handpieces do not
recognize blade types.

26    10600181 Rev. M DYONICS™ POWER II Control System   Operations/Service Manual


Operation

Programmed Blade Speeds


Forward Reverse Oscillate Mode 1 Oscillate Mode 2
Handpiece Maximum (Speed) RPM (RPM) (RPM) (RPM) (RPM)
Range Default Range Default Range Default Range Default
DYONICS POWERMAX™ 3000 100–3000 2000 100–3000 2000 500–3000 2000 1–9 (1 Rev) 8 (2 Rev)
ELITE 1–8 (2 Rev)

5000 100–5000 2000 100–5000 2000 500–3000 2000 1–9 (1 Rev) 8 (2 Rev)
1–8 (2 Rev)
8000 500–8000 4000 500–8000 4000 500–3000 2000 1–9 (1–2 Rev) 9 (2 Rev)

10000* 500–10000 5000 500–10000 5000 500–3000 2000 1–9 (1–2 Rev) 9 (2 Rev)

DYONICS POWERMINI™ 3000 100–3000 2000 100–3000 2000 500–3000 3000 1–9 (1–2 Rev) 8 (2 Rev)

5000 100–5000 3500 100–5000 3500 500–3000 3000 1–9 (1–2 Rev) 9 (2 Rev)

6000 500–6000 6000 500–6000 6000 500–3000 3000 1–9 (1–2 Rev) 9 (2 Rev)

DYONICS POWER 5000 100–5000 3000 100–5000 3000 500–3000 1000 N/A N/A
Ultralight**
DYONICS Mini Motor 3500 100–3500 2000 100–3500 2000 500–3000 1000 N/A N/A
Drive

Table 2.   Programmed Blade Speeds

* Only the DYONICS POWERMAX ELITE Handpieces will support the maximum speeds of up to 10000 (REF 72200616, 72200617).
** All standard burrs run at 5000 rpm when used in the Ultralight Handpiece (REF 7205971).

Set Forward and Reverse Blade Speed


1. On the handpiece, press the Forward or Reverse button.
2. On the Control screen, press the Up button once to increase
the speed by one increment. Press the Down button once to
decrease the speed by one increment. Press and hold an Up or
Down button to quickly make large adjustments to set speed.

Operations/Service Manual   DYONICS™ POWER II Control System 10600181 Rev. M  27


Cleaning and Sterilization

Cleaning and Sterilization Handpieces and Powered Instruments


For information regarding the cleaning and sterilization of
Control Unit handpieces and powered instruments, refer to the Smith &
CAUTION: Do not sterilize or immerse the Smith & Nephew Nephew DYONICS Handpieces Instructions for Use and the
DYONICS™ POWER II Control Unit in disinfectant. Smith & Nephew DYONICS Powered Instruments Instructions
for Use, respectively.
The control unit should be disconnected from the grounded AC
outlet when being cleaned. The exterior surface of the control
unit may be wiped down with any liquid disinfecting solution;
non-flammable solution should be used whenever possible. Do
not allow any liquid to pass into any electrical connections or the
interior of the control unit. Allow surfaces to dry thoroughly before
plugging in the device.
Periodically clean any dust or debris from the cooling vents on the
bottom of the control unit and from the fan housings on the rear of
the unit (Figure 2).

Footswitch
For information regarding cleaning the DYONICS POWER II
Footswitch, refer to the Instructions for Use included with the
footswitch.
For all other footswitches, follow this procedure after each
operation to clean the footswitch:
1. Disconnect the footswitch cable from the control unit.
2. Wipe the footswitch and footswitch cable with a clean damp
cloth (and mild germicide or isopropyl alcohol).
3. Dry the cable connector completely before connecting to the
control unit footswitch connector port.

28    10600181 Rev. M DYONICS™ POWER II Control System   Operations/Service Manual


Service/Maintenance

Service Maintenance
Service Information Preventive Maintenance
There are no user serviceable components inside the DYONICS™ Smith & Nephew recommends that Dielectric Strength, Earth
POWER II Control System. Repairs and adjustments are to be Leakage Current, and Protective Earth Testing be performed
performed only by Smith & Nephew authorized service centers. annually to assure continued compliance with applicable safety
If service becomes necessary, call an authorized Smith & requirements. These tests should be conducted in accordance
Nephew Customer Service representative prior to returning with specifications IEC 60601-1.
the device and request a Return Authorization (RA) number. CAUTION: Electrical safety testing should be performed by a
Customer Service can also explain the available Service biomedical engineer or other qualified person.
Replacement and Repair Programs.
Service items should be carefully disinfected and repackaged.
Replacing/returning worn or defective equipment
Return postpaid to Smith & Nephew. Smith & Nephew Customer or parts
Service can provide additional instructions. Contact Smith & Nephew to order a shaver interface cable or any
Product returned that is found to have been serviced by an accessories, and for instructions on disinfection and return of worn
unauthorized third party repair facility and/or sterilized with a or defective equipment or parts.
sterilization method other than one approved by Smith & Nephew
will incur additional costs, regardless of warranty status.
It is not necessary to include accessory items (i.e., power cords,
etc.) when returning a device for service.

Replace Rear Panel Fuses


The rear panel shown in Figure 2 includes a removable fuse tray
containing two fuses. Always replace both fuses. To replace the
fuses:
1. Disconnect the unit from the power source.
2. Locate the fuse tray just above the power cord socket (refer to
Figure 2).
3. Use a slotted screwdriver to press the fuse tray tabs in toward
the center of the tray.
4. Slide the fuse tray out.
5. Replace the fuses with 10 amp/250 V Time-Lag (SLO-BLO™)
fuses (REF 91001646).
6. Slide the fuse tray into the holder until the tabs snap into place.
7. Reconnect the unit to the power source.
Note: Blown fuses usually indicate a short circuit or a failed
component. Make sure components are properly interconnected.
If the problem persists, contact Smith & Nephew Customer Service
for troubleshooting assistance.

Operations/Service Manual   DYONICS™ POWER II Control System 10600181 Rev. M  29


Troubleshooting

Troubleshooting
Observed Problems
If no Warning or Fault messages are displayed and the system is not performing as expected, refer to Table 3 for possible remedies.
Contact an authorized Smith & Nephew representative if the suggested remedies do not correct the problem.
If this occurs... The problem may be... And this may help...
LCD display screen remains blank Electrical power cord may be loose. Check electrical power cord at control unit and at wall
when the Power Up button is socket.
pressed. If problem persists contact an authorized Smith & Nephew
representative.

The DYONICS™ POWER II Control The communication link between Check the cable connections between the control unit and
Unit does not respond when the the control unit and the footswitch or footswitch or device.
footswitch or device controls are device has been interrupted. If the problem persists, contact an authorized
pressed. Smith & Nephew representative.

LCD touch screen controls do not Multiple buttons are being pressed at Use only one finger at a time when operating the LCD
respond or respond incorrectly the same time. touch screen. Multiple, simultaneous finger presses can
when pressed. result in unintended changes to settings and erroneous
control inputs.
If the problem persists, contact an authorized
Smith & Nephew representative.

Touch screen is dirty. Unplug the unit and wipe the touch screen down using a
non-flammable solution.

Pump icon is missing or pump The shaver control unit has lost Check the shaver interface cable connection. Reconnect if
icon flashes for five seconds and communication with the pump necessary. Check the shaver interface cable and replace
then disappears. control unit. if damaged.
Ensure that the pump control unit is turned on.

30    10600181 Rev. M DYONICS™ POWER II Control System   Operations/Service Manual


Troubleshooting

Warning Messages
Short Warning Message Full Warning Message Corrective Action
TEMPERATURE-LIMIT Unit overheating. Check for Check the fans on the control unit rear panel. Ensure there are no
or blocked ventilation. obstructions. Ensure the fans are running while the control unit is
Check fans. powered on. If either fan is not running, contact an authorized Smith
OVER-TEMPERATURE & Nephew representative.
Check the vents located on the base of the control unit for blockage.
Do not run the control unit if it continues to overheat or it will be
damaged. Contact an authorized Smith & Nephew representative.
Unknown Blade Blade type not supported for Check to make sure the blade is properly inserted. Try another blade.
connected handpiece. Handpiece
is operating in Safe Mode.
Unknown Handpiece Handpiece not recognized/ Check to make sure the handpiece cable is properly connected to
supported. Try a different the front panel. Switch handpiece to the other port. Try a different
handpiece. handpiece.
Handpiece Sensor Fault Handpiece sensor fault. Check to make sure the handpiece cable is properly connected
Handpiece is operating in to the front panel. Switch handpiece to the other port. Try another
Safe Mode. handpiece.
Blade Stall Handpiece or blade is stalled. Remove the blade and check for rotation manually. With the blade
Stop the handpiece and check removed, turn the motor on and verify that it is turning by looking into
the blade. the end of the handpiece. Try another blade.
Handpiece Stall Handpiece motor not running. Try Try a different handpiece.
a different handpiece.
Handpiece Motor Fault Try other port. If problem persists Switch the handpiece to the other port. Try a different handpiece.
try a different handpiece.
Short Circuit Detected Handpiece or port short Try a different handpiece. If the problem persists, contact an
circuit detected. Try a different authorized Smith & Nephew representative.
handpiece. If problem persists
return unit for repair.
Handpiece Overload Handpiece overload detected. Turn the handpiece off. Turn it back on. If the problem persists, try a
different handpiece.
Handpiece Overload Handpiece overload detected. Try Turn the handpiece off. Turn it back on. If the problem persists, try a
Timeout a different handpiece. different handpiece.
Handpiece Error Check handpiece for depressed Check to make sure the handpiece cable is properly connected to
buttons. If none present try a the front panel. Switch handpiece to the other port. Try a different
different handpiece. handpiece.
Unknown Footswitch Unable to communicate with Check to make sure the footswitch cable is properly connected to the
footswitch. Try a different front panel. Try a different footswitch.
footswitch.
Footswitch Error Check footswitch for depressed Check to make sure that the footswitch cable is properly connected to
pedals or switches. If none the front panel. Try a different footswitch.
present try different footswitch.

Operations/Service Manual   DYONICS™ POWER II Control System 10600181 Rev. M  31


Troubleshooting

Warning Messages (continued)


Short Warning Message Full Warning Message Corrective Action
Footswitch Required Handpiece does not have hand Connect footswitch to the front panel. Ensure that footswitch is set to
controls and requires a footswitch. same port as handpiece.

Unable to Save Contact an authorized Smith & Nephew representative.


Custom Settings

Unable to Save Contact an authorized Smith & Nephew representative.


Set Speeds

Unable to Retrieve Contact an authorized Smith & Nephew representative.


Custom Settings

Unable to Retrieve Contact an authorized Smith & Nephew representative.


Set Speeds

Fault Messages
Fault Message Problem Corrective Action
SYSTEM ERROR 1 The control unit has detected a Restart the control unit. If the fault recurs, contact an authorized
system error. Smith & Nephew representative.

SYSTEM ERROR 2 The control unit has detected a Restart the control unit. If the fault recurs, contact an authorized
system error. Smith & Nephew representative.

SYSTEM ERROR 3 The control unit has detected a Restart the control unit. If the fault recurs, contact an authorized
system error. Smith & Nephew representative.

SYSTEM ERROR 4 The control unit has detected a Restart the control unit. If the fault recurs, contact an authorized
system error. Smith & Nephew representative.

32    10600181 Rev. M DYONICS™ POWER II Control System   Operations/Service Manual


Technical Specifications

Technical Specifications*
Control Unit Dimensions 5.75" H x 12" W x 14.25" D
146 mm H x 305 mm W x 362 mm D
Control Unit Weight 13.85 lbs/6.28 kg

Power Requirements 100–240 VAC, 50/60 Hz, 560 VA

Leakage Current Typical 45 µA at 115 VAC and 90 µA at 230 VAC

Protection Class 1, Type B Applied Part – continuous operation.


Controls Power Up/Power Down, LCD Touch/Display Screen. Touch screen controls are described in the
“Preoperative Setup” and “Operation” sections of this manual.
Footswitches Footswitch controls vary based on footswitch type. Controls include: forward, reverse, increase forward or
reverse speed when in variable mode, decrease forward or reverse speed when in variable mode, start,
stop, oscillate, blade window lock, and lavage.
Displays LCD Touch/Display Screen. Touch screen displays are described in the “Preoperative Setup” and “Operation”
sections of this manual.

Connections Power cord connector, footswitch connection port, Port A device connection port, Port B device connection
port, USB, Ethernet, bidirectional ports, DB9 interface connection, and an equipotential compensation
terminal.

Compliance IEC 60601-1:1988+A1:1991+A2:1995


**IEC 60601-1:2005 +A1:2012 IEC 60601-1-2:2014.
*Specifications subject to change without notice.
** Applies to units with serial numbers of AAX-5001 or greater.

Environmental Conditions
Condition Transport and/or storage Use
-20° to +60° C 10° to 40° C
Ambient Temperature
-4° to 140° F 50° to 104° F
Humidity 20–90% (no condensation allowed) 30–70% (no condensation allowed)
Atmospheric Pressure 500–1060 hPa 700–1060 hPa

Factory Defaults
Custom / Blade Default
Blade Default
(Settings Screen)
Port A Port B
Current Mode Mode 1 Mode 1
Oscillate Mode
Mode 1 – Seconds 0.30 0.30
Mode 2 – Revolutions 2 2
Mode Variable
Port Control Port A
Footswitch
Hand Control Override On
Forward R
Pump Interface Port Control Port A

Operations/Service Manual   DYONICS™ POWER II Control System 10600181 Rev. M  33


Ordering Information/Accessories

Ordering Information/Accessories
Each Smith & Nephew DYONICS™ POWER II Control System includes a DYONICS POWER II Control Unit, country-specific power cord,
shaver interface cable, country-specific DYONICS POWER II Control System Operations/Service Manual, country-specific Smith &
Nephew DYONICS Handpieces Instructions for Use and country-specific DYONICS Powered Instruments Instructions for Use.
REF Description
72201030 DYONICS POWER II Control System, US
72201034 DYONICS POWER II Control System, UK
72201037 DYONICS POWER II Control System, German
72201040 DYONICS POWER II Control System, Spanish
72201043 DYONICS POWER II Control System, French
72201046 DYONICS POWER II Control System, Italian
72201049 DYONICS POWER II Control System, Swedish
72201052 DYONICS POWER II Control System, Dutch
72201055 DYONICS POWER II Control System, Portuguese
72201058 DYONICS POWER II Control System, Danish
72201061 DYONICS POWER II Control System, Norwegian
72200873 DYONICS POWER II Control Unit
72205189 Smith & Nephew LINK - DYONICS Power II
91000973 DYONICS 25 Shaver Interface Cable
72201092 DYONICS POWER II Footswitch, Pedal-style, on/off or variable speed
7205399 DYONICS POWER Footswitch, low profile, on/off
7205397 DYONICS Low Profile Variable (Accelerator) Footswitch
7205396 DYONICS POWER Footswitch, pedal-style, on/off
72203626 DYONICS POWER Footswitch Pedal Style - Clickless
72203139 DYONICS POWER Interface Cable B
72203140 DYONICS POWER II Interface Cable C
605-0004 Hospital Grade Power Cord, U.S.
8013380 International Power Cord
10600181 Smith & Nephew DYONICS POWER II Control System Operations/Service Manual
10600266 Smith & Nephew DYONICS Handpieces Instructions for Use
10600341 Smith & Nephew DYONICS Powered Instruments Instructions for Use

WARNING: The DYONICS 25 Fluid Management System and the LINK may 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 non-validated cables will void the warranty.
CAUTION: Inspect all components regularly for wear. Pay particular attention to potential damage to insulation, especially with universal
extension cables.
Note: Smith & Nephew DYONICS POWER II Control System devices must be used in a manner consistent with the instructions for use
packaged with these devices.

34    10600181 Rev. M DYONICS™ POWER II Control System   Operations/Service Manual


Electromagnetic Emissions/Separation Distances

Electromagnetic Emissions
The Smith & Nephew DYONICS™ POWER II Control System is intended for use in the electromagnetic environment specified below.
The customer or the user of the DYONICS POWER II Control System should assure that it is used in such an environment.
The Smith & Nephew DYONICS POWER II Control System was tested to the following:
IEC/EN 60601-1-2: 2014/2015
Specification IEC 60601-1-2 (2014) / EN 60601-1-2 (2015) MEDICAL ELECTRICAL EQUIPMENT - Part 1-2: General
requirements for basic safety and essential performance - Collateral Standard: Electromagnetic
disturbances - Requirements and tests
Test Method IEC CISPR 11 (2010) / EN 55011 (2010), Industrial, scientific and medical equipment - Radio-frequency
disturbance characteristics - Limits and methods of measurement Radiated
Emissions Test Compliance Electromagnetic Environment – Guidance
RF emissions CISPR 11 Group 1 Environment, Professional The DYONICS POWER II Control System is suitable for use in
Healthcare Facility, and not compatible a Professional Healthcare environment where utility mains are
with a Magnetic Resonance (MR) privately used by the Healthcare Facility.
environment.
Note: The EMISSIONS characteristics of this equipment make
RF emissions CISPR 11 Class A it suitable for use in industrial areas and hospitals (CISPR 11
class A). If it is used in a residential environment (for which
CISPR 11 class B is normally required) this equipment might not
offer adequate protection to radio-frequency communication
services. The user might need to take mitigation measures,
such as relocating or re-orienting the equipment.
Warning: Use of accessories, handpieces, powered
instruments and cables with this equipment, other
than those specified or provided by the Smith & Nephew
could result in increased electromagnetic emissions or
decreased electromagnetic immunity and result in
improper operation.
Harmonic emissions N/A
EN 61000-3-2
Voltage fluctuations/flicker N/A
emissions
EN 61000-3-3

Separation Distances
WARNING - Electrical Interference. This equipment is designed to be used as a stand-alone, in proximity too, or in a
stacked configuration with other medical equipment. Although this equipment is designed and tested to minimize
interference with, or by, other electrical equipment; interference may occur. 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.

Operations/Service Manual   DYONICS™ POWER II Control System 10600181 Rev. M  35


Electromagnetic Immunity

Electromagnetic Immunity
The Smith & Nephew DYONICS POWER II Control System is intended for use in the electromagnetic environment specified below.
The customer or the user of the DYONICS POWER II Control System should assure that it is used in such an environment.
Specification IEC 60601-1-2 (2014) / EN 60601-1-2 (2015) MEDICAL ELECTRICAL EQUIPMENT - Part 1-2: General
requirements for basic safety and essential performance - Collateral Standard: Electromagnetic
disturbances - Requirements and tests

Test Method EN 61000-4-2 (2009) / IEC 61000-4-2 (2008), Electromagnetic compatibility (EMC) – Part 4-2: Testing and
measurement techniques – Electrostatic discharge immunity test
EN 61000-4-3 (2010) / IEC 61000-4-3 +A1+A2 (2010), Electromagnetic compatibility (EMC) – Part 4-3:
Testing and measurement techniques – Radiated, radio-frequency, electromagnetic field immunity test
EN 61000-4-4 (2012) / IEC 61000-4-4 (2012), Electromagnetic compatibility (EMC) – Part 4-4: Testing and
measurement techniques – Electrical fast transient/burst immunity test
EN 61000-4-5 (2006) / IEC 61000-4-5 (2005), Electromagnetic compatibility (EMC) – Part 4-5: Testing and
measurement techniques – Surge immunity test
EN 61000-4-6 (2014) / IEC 61000-4-6 (2013), Electromagnetic compatibility (EMC) – Part 4-6: Testing and
measurement techniques – Immunity to conducted disturbances, induced by radio-frequency fields
EN 61000-4-8 (2010) / IEC 61000-4-8 (2009), Electromagnetic compatibility (EMC) – Part 4-8: Testing and
measurement techniques – Power frequency magnetic field immunity test
EN61000-4-11 (2004) / IEC 61000-4-11 (2004), Electromagnetic compatibility (EMC) – Part 4-11: Testing and
measuring techniques – Voltage dips, short interruptions and voltage variations immunity tests
Electromagnetic Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative
Environment – Guidance humidity should be at least 30%.
All portable and mobile RF communications equipment, including cables, should be at least
30 cm (12 inches) from any part of the DYONICS POWER II Control System.
Field strengths from RF transmitters, such as base stations for radio, (cellular/cordless) telephones, land
mobile radios, amateur radios, AM and FM radio broadcasts, and TV broadcasts cannot be predicted. The
Professional Healthcare Facility must assess the electromagnetic environment due to RF transmitters, an
electromagnetic site survey should be considered to ensure compatibility with the immunity levels contain
in IEC/EN 60601-1-2.
The DYONICS POWER II Control System normal operation is to control the speed of operation of the hand
pieces and powered instruments.
WARNING: Abnormal performance, due to Electromagnetic Disturbances, may be
manifested by a failure to properly maintain the speed of operation of the hand pieces
and powered instruments. If abnormal performance is observed, 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.
WARNING: Use of accessories, handpieces, powered instruments and cables with this
equipment, other than those specified or provided by the Smith & Nephew, could result
in increased electromagnetic emissions or decreased electromagnetic immunity and result in
improper operation.

36    10600181 Rev. M DYONICS™ POWER II Control System   Operations/Service Manual


Special Environment

Special Environment
The DYONICS POWER II Control System is intended for use in a Special Environment using HF surgical equipment.
WARNING - High Frequency (HF) Interference: This equipment was designed and tested to be used with
HF Electrical Surgical Unit (ESU) equipment. 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.

Operations/Service Manual   DYONICS™ POWER II Control System 10600181 Rev. M  37


Warranty
Smith & Nephew products are guaranteed to be free from defects in material and workmanship
for the warranty period for a particular product, beginning from date of invoice. Refer to the current
Smith & Nephew Product Catalog or contact Smith & Nephew Customer Service for specific
warranty information.
This limited warranty is restricted to repair or replacement by Smith & Nephew, at its option, of any
product found to be defective during the warranty period. Damage inflicted to a product by the user
that causes it to be unsuitable for refurbishment may result in additional charges, regardless of
warranty status. All warranties apply to the original buyer only. In no event shall Smith & Nephew be
liable for any anticipated profits, consequential damages, or loss of time incurred by the buyer with
the purchase or use of any product.
NO OTHER WARRANTY, EXPRESSED OR IMPLIED, IS GIVEN.

Service Replacement Units Warranty


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

Service Replacement Program


Smith & Nephew offers a 24-hour Service Replacement Program for its products to minimize
downtime in the operating room. Our goal is to ship a service replacement unit within 24 hours**
of a call (during normal business hours). For a Return Authorization (RA) number or for additional
information on this program, call Customer Service at +1 800 343 5717 in the U.S., or contact your
authorized representative.
**24-hour shipment is not offered in all countries.

Repair Service Program


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

™Trademarks of Smith & Nephew. Certain marks registered U.S. Patent & Trademark Office. All trademarks acknowledged.
Covered by one or more of the following U.S. patent numbers: 5,510,070; 5,563,481; 5,602,449; 5,620,447; 5,630,826; 5,672,945;
5,712,543; 5,745,647; 5,749,885; 5,804,936; 5,833,692; 5,871,493; 5,913,867; 6,090,122; 6,328,752; 7,150,713; 7,510,563; Des. 381,425;
other patents pending.

Endoscopy www.smith-nephew.com Smith & Nephew Orthopaedics GmbH


Smith & Nephew, Inc. Alemannenstraße 14
©2007, 2019 Smith & Nephew, Inc.
150 Minuteman Road +1 978 749 1000 Telephone 78532 Tuttlingen
All rights reserved.
Andover, MA 01810 +1 978 749 1108 Fax Germany
USA +1 800 343 5717 U.S. Customer Service [email protected] 06/2019 10600181 Rev.M

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