DYONICS 25 Fluid Management System Operations and Service Manual Rev F

PSOR206

PSOR206

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

Warning, magnetic field

CAUTION: See Instructions for Use

Do not touch

Power up/power down

Dangerous voltage: dDanger of electric shock

Corded remote control connection port

Alternating current

Tube set cassette lock/release

Fuse T 1A 250V

Start

AC power input

Stop

CE mark

Up and Down buttons

UL Classification

Day Tube Set icon

Catalog number

Inflow Tube Set icon

Date of manufacture

Inflow/Outflow Tube Set icon

Serial number

Remote connected icon

Serial port

Shaver connected icon

Bidirectional port

Pump status icon

Shaver port

Smith & Nephew DYONICS 25 Fluid Management System Operations/Service Manual

1061600 Rev. F

3

PSOR206

Glossary of Symbols (continued) USB port

Single use only. Do not reuse.

Ethernet port

Sterile, Ethylene Oxide

EQUIPMENT CLASSIFICATION -- Patient Isolation Type BF Applied Part

Use for one surgical day only. Do not reuse.

Equipotentiality

European Representative

EU: Not for general waste

Do not sterilize

Keep dry

This end up

Fragile; handle with care

Temperature range

Humidity

Expiration date

Lot number

Latex free

DEHP free

4

1061600 Rev. F

Smith & Nephew DYONICS 25 Fluid Management System Operations/Service Manual

PSOR206

Preface / Table of Contents

Preface This manual contains the information you need to operate and maintain the Smith & Nephew DYONICS™ 25 Fluid Management System. It is essential that you read and understand all the information in this manual before using or maintaining the system.

Table of Contents Glossary of Symbols...3–4 Introduction...6 Indications for Use...6 Contraindications...6 Warnings...7 Precautions...7–8 System Components...9 Disposable Tube Sets...9 Inflow Only Tube Set...9 Inflow/Outflow Tube Sets...10 Day Tube Set...10 Smith & Nephew DYONICS 25 Wireless Remote Control...11 Smith & Nephew DYONICS 25 Remote Control...11 Smith & Nephew LEVELERT™ II Fluid Level Sensor...12 Smith & Nephew DYONICS 25 System Shaver Interface Cable...12 Use with Non-Smith & Nephew Shavers...12 Smith & Nephew Procedure Cart...12 Accessories...12 Unpacking and General Inspection . . .13 U.S. Fluid Management System...13 International Fluid Management System...13 Front Panel Layout...14 Rear Panel Layout...15 Side Panel Layout...16 Other Indicators...16 Remote Control Layouts...17 Recommended System Configuration .18 Preoperative Setup...19 Cannulas...19 Control Unit Setup...20 LEVELERT II Fluid Level Sensor Setup . .21 Inflow Tube Set Preparation...21 Day Tube Set/Patient Tube Set Preparation...21 Inflow/Outflow Tube Set Preparation .22 Wireless Remote Control Setup...23 Shaver Control Unit Integration...24

Settings...24 Change the system language...24 Review System Information...25 Custom Settings...25 Program custom pressure settings .25 Program custom flow rate settings .26 Program custom cannula settings .26 Program custom suction settings . .27 Blade Speed Chart...27 Custom Mode...28 Operation...29 Replacing Irrigation Bags During Surgery...29 Repriming Cassette...29 Converting to a Gravity-Fed System . .29 Directing Suction...29 Adjusting Suction Rate...29 Cannula Selection...30 Cannula Technique...30 Operational modes...30 Inflow Tube Set Mode...31 Inflow/Outflow Tube Set, Shaver Detected Mode...32 Blade Speed Chart...34 Inflow/Outflow Tube Set, Shaver Not Detected Mode...35 Day Tube Set Mode...36

Service...45 Service Philosophy...45 Maintenance...46 Replacing Fuses...46 Replacing / returning worn or defective equipment or parts...46 Preventive Maintenance...46 Smith & Nephew LEVELERT II Fluid Level Sensor...46 Smith & Nephew Procedure Cart...46 Biomed Test Mode...47–48 Technical Specifications...49–50 Ordering information...51–52 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions...53 Guidance for Separation Distances...53 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity...54–55 Warranty...Back Cover Service Replacement Program...Back Cover Repair Service Program...Back Cover TABLES

Cleaning and Sterilization...38 Smith & Nephew DYONICS 25 Fluid Management System...38 Smith & Nephew DYONICS 25 Remote Control...38 Smith & Nephew DYONICS 25 Wireless Remote Control...38 Smith & Nephew DYONICS 25 Tube Sets...38 Smith & Nephew DYONICS 25 Day Tube Set...38

Table 1: Suggested DYONICS 25 cannula settings based on cannula and arthroscope size...19

Troubleshooting...39–41 Observed Problems...39 Observed Problems Table...39–41

Pressure and Flow Rate Limit Settings Table...50

Warning Message Table...42–43 Fault Message Table...44

Smith & Nephew DYONICS 25 Fluid Management System Operations/Service Manual

Table 2: Minimum and maximum flow rates for cannulas...26 Blade Speed Chart...27, 34 Observed Problems Table...39–41 Warning Message Table...42–43 Fault Message Table...44 Applied Pressure Table...48

Suction Settings – Shaver Detected Table...50 Suction Settings – Shaver Not Detected Table...50

1061600 Rev. F

5

PSOR206

Introduction

Introduction The Smith & Nephew DYONICS™ 25 Fluid Management System provides for the measurement of fluid pressure and flow rate during arthroscopic procedures. The DYONICS 25 Fluid Management System is a microprocessor-controlled irrigation-aspiration system that controls joint pressure independently of aspiration rate over a wide range of flow rates. Smith & Nephew DYONICS 25 System components consist of a main control unit, disposable tubing sets, a wired remote control, two Smith & Nephew LEVELERT™ II Fluid Level Sensors, a shaver system interface cable, a procedure cart (U.S. only) and U.S. and international power cords. The system will maintain control of intra-articular pressure regardless of varying outflow rates. The system can also be used with any arthroscopic inflow cannula.

system can decrease outflow to a preselected shaver idle rate to conserve fluid. CAUTION: The Smith & Nephew DYONICS 25 Fluid Management System and the devices used with it should only be used by physicians who have received training in their use.

Indications for Use The Smith & Nephew DYONICS 25 System is indicated for use during arthroscopic joint surgery to regulate flow of irrigation fluids in the knee, shoulder, hip, and small joints to maintain intra-articular pressure for uniform distension and clear visualization of the surgical site.

Contraindications None known.

Distension pressure and outflow are independently regulated by the user. The DYONICS 25 System’s centrifugal pump technology does not require the user to increase distension pressure to achieve high flow rates. Outflow may be adjusted while maintaining the lowest distension pressure needed. The DYONICS 25 Fluid Management System is designed to be linked with the Smith & Nephew DYONICS POWER Shaver System, Smith & Nephew EP-1™ Shaver Control System, or Smith & Nephew PS3500EP ™ Arthroscopic Surgical System. When the DYONICS 25 System is used with the Smith & Nephew DYONICS POWER, EP1 or PS3500EP Shaver, operation of the fluid management system and powered shaver system is linked and outflow regulation occurs automatically. Specifically, data concerning the speed of the arthroscopic blade in use is transmitted via a cable from the shaver control unit to the DYONICS 25 System Control Unit and processed. When the blade is in use, the system immediately initiates an automatic adjustment of the pinch valve to provide the shaver outflow rate preselected by the user. Alternately, when the powered blade is idle, the

6

1061600 Rev. F

Smith & Nephew DYONICS 25 Fluid Management System Operations/Service Manual

PSOR206

Warnings and Precautions

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 Smith & Nephew DYONICS™ 25 System must be monitored during use. If overpressurization is suspected, press the pump Drain the fluid from the joint.

STOP button.

• If air is introduced into the tubing and cassette, press the pump STOP button and reprime the cassette according to the instructions described under “Operation – Repriming Cassette.” Failure to do so may result in overpressurization of the joint. • To prevent electric shock, unplug the unit from the electrical outlet before attempting to replace fuses. • To avoid fire hazard, use only fuses of the correct type, voltage rating, and current rating. • This device is not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. • During setup, it is critical to insure that the cassette supply line is fully purged of air and that there are no bubbles in the supply line leaving the cassette. • The flush valve on the inflow cannula may be opened momentarily (two seconds maximum) to flush the joint. During normal use, the flush valve should remain completely closed to ensure accurate pressure control. Failure to completely close the flush valve may result in overpressurization of the joint. • Do not connect a suction source to the outflow barb of the inflow cannula. Overpressurization of the joint can occur if a suction source is connected to the outflow barb of the inflow cannula. • Improper cannula setting can lead to inaccurate pressure settings, pressure and flow rate fluctuations, and overpressurization of the joint. • Insert only empty tube set cassettes into the cassette slot. Tube sets under pressure from the irrigation bags can cause inaccurate pressure and flow rate readings or trigger error messages. • Do not place the Smith & Nephew DYONICS 25 System Control Unit above any electrical or electronic equipment that may be damaged by a spill.

• Grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle marked “Hospital Grade.” • To avoid tipping the procedure cart, do not suspend more than 12 liters of fluid from the IV pole. • Do not suspend more than 5 liters of fluid from the LEVELERT™ II hook. • The DYONICS 25 Remote Control is shipped nonsterile. To use the remote in the sterile field, the remote and its cord must be securely enclosed in a sterile bag using aseptic techniques in accordance with standard operating room procedures. • The DYONICS 25 Wireless Remote Control is shipped non-sterile. To use the remote in the sterile field, the remote must be securely enclosed in a sterile bag using aseptic techniques in accordance with standard operating room procedures. • The sterile bag included in the Smith & Nephew Inflow/Outflow, Patient, and Inflow Tube Sets is only for use with the Smith & Nephew Wireless Remote Control. Do not use the sterile bag with any corded remote control or any other devices. • The Smith & Nephew Day Tube Set is to be used for one surgical day only. Do not resterilize. Do not reuse the Day Tube Set for more than one surgical day.

Precautions U.S. Federal law restricts this device to sale by or on the order of a physician. • The Smith & Nephew DYONICS 25 Fluid Management System and the devices used with it should be used only by physicians who have received training in their use. • Prior to each use, inspect the device to ensure it is functioning properly and not damaged. Do not use a damaged device. • Inspect all components regularly for wear. • Use only Smith & Nephew devices and cables with the Smith & Nephew DYONICS 25 Fluid Management System. • Check the LCD display screen to ensure that the proper settings are displayed prior to beginning any procedure.

Smith & Nephew DYONICS 25 Fluid Management System Operations/Service Manual

1061600 Rev. F

7

PSOR206

Precautions (continued)

• Use only the power cord and connector specified for this unit. • Electrical Interference: This equipment is designed and tested to minimize interference with other electrical equipment. However, if interference occurs with other equipment, it may be corrected by one or more of the following measures: • Reorient or relocate this equipment, the other equipment, or both. • Increase the separation between the pieces of equipment. • Connect the pieces of equipment into different outlets or circuits. • Consult a biomedical engineer. • Check that the electrical equipment is properly grounded (i.e., plugs contain a ground prong). Grounding reliability can be achieved only when the DYONICS™ 25 System is connected to an equivalent AC power receptacle marked “hospital only” or “hospital grade.” • 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 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, return it 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.

8

1061600 Rev. F

• Use only the Smith & Nephew Disposable Tube Sets with the Smith & Nephew DYONICS 25 Fluid Management System. • Dispose of the cassette and all plastic cannula sets used during the operation following standard procedures for biohazardous waste. • The Smith & Nephew DYONICS 25 System is supplied with a shielded communications cable for connection to the Smith & Nephew DYONICS POWER, EP-1™, or PS3500EP™ control units. This cable must be used to ensure compliance with all applicable IEC 60601-1 safety standards and IEC 60601-1-2 Class “A” EMC standards. • Excessive hand pressure when squeezing the irrigation bag to induce flow may cause overpressurization of the joint. • 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. • Press the power up/power down button to turn off the DYONICS 25 System. Failure to do so may result in lost custom settings and difficulty in removing the tube set cassette from the DYONICS 25 system. • Do not place the Smith & Nephew DYONICS 25 System Control Unit above any electrical or electronic equipment that may be damaged by a spill. • Remove the wireless remote control batteries if the remote is not to be used for an extended period of time. • Wireless remote control batteries should be disposed of in accordance with any applicable national or institutional policy relating to disposable batteries. • 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.

Smith & Nephew DYONICS 25 Fluid Management System Operations/Service Manual

PSOR206

System Components

System Components

Disposable Tube Sets

The DYONICS™ 25 System provides controls and displays for line power, default mode, custom mode, starting and stopping pumping, adjusting pressure settings, adjusting flow rate limit settings, adjusting suction settings, selecting blade speed, selecting cannula setting, starting and stopping lavage mode, and restoring system defaults.

For each procedure, one sterile, disposable Smith & Nephew DYONICS 25 Tube Set is required, but not included. The Inflow and Day Tube Sets need to be supplemented by standard hospital suction tubing.

An LCD screen displays all of the controls needed to set up and operate the DYONICS 25 System. The LCD screen contains a Message Box, which displays the pump status (pumping or gravity inflow), shaver control unit recognition, system prompts, lavage time remaining, custom mode, default mode, fault and warning messages, and status.

Note: The Smith & Nephew DYONICS 25 Inflow Tube Set, Inflow/Outflow Tube Set-Single Suction, Inflow/Outflow-Forked Suction Tube Set, and Patient Tube Set each include a sterile bag for wrapping the Smith & Nephew DYONICS 25 Wireless Remote Control for use in the sterile field. The Smith & Nephew DYONICS 25 Day Tube Set does not contain a sterile bag.

The DYONICS 25 Remote Control allows the pump operation to be controlled remotely via the remote connection cable.

WARNING: The sterile bag included in the Smith & Nephew Inflow/Outflow, Patient, and Inflow Tube Sets is only for use with the Smith & Nephew Wireless Remote Control. Do not use the sterile bag with any corded remote control or any other devices.

The DYONICS 25 Wireless Remote Control allows the pump operation to be controlled via infrared signal.

CAUTION: Use only Smith & Nephew DYONICS 25 Tube Sets with the Smith & Nephew DYONICS 25 Fluid Management System.

The DYONICS 25 System is designed for use with Smith & Nephew DYONICS 25 Tube Sets (REFs 7211004, 7211005, 7211006, 7211007, and 7211008). The Smith & Nephew DYONICS™ 25 Tube Sets are used to deliver irrigation fluid to the joint. The DYONICS 25 System selects an operational mode based upon the type of tube set inserted at startup. The DYONICS 25 System has four operational modes: Inflow Tube Set; Inflow/Outflow Tube Set – Shaver Detected; Inflow/Outflow Tube Set – Shaver NOT Detected; and Day Tube Set. The DYONICS 25 System has been designed to meet UL and IEC 60601 safety and performance standards for medical equipment. The CE mark on the pump signifies compliance with Medical Device Directive 93/42/EEC.

Inflow Tube Set The Smith & Nephew DYONICS™ 25 Inflow Tube Set (REF 7211004) has two lengths of tubing (Figure 1). The first length of tubing provides an inflow pathway from an irrigation bag to the cassette (1-A). The second (blue) length of tubing (1–B) delivers fluid from the cassette through the inflow cannula into the joint space.

B A Figure 1. DYONICS 25 Inflow Tube Set

Smith & Nephew DYONICS 25 Fluid Management System Operations/Service Manual

1061600 Rev. F

9

PSOR206

System Components (continued)

Inflow/Outflow Tube Sets

Day Tube Set

The Smith & Nephew disposable cassette and integrated tube sets contain a pump rotor and two pressure transfer devices. The disposable Smith & Nephew DYONICS™ 25 Inflow/Outflow, Single Suction Tube Set (REF 7211005) and the disposable Smith & Nephew DYONICS 25 Inflow/Outflow, Forked Suction Tube Set (REF 7211006) consist of four lengths of PVC tubing preconnected to the cassette (Figure 2). One length of tubing (2–A) serves as the inflow pathway from an irrigation bag to the cassette. The second (blue) length of tubing (2–B) delivers fluid from the cassette through the inflow cannula into the joint space. The third length of tubing (2–C) directs outflow from the joint to the suction control line contained in the disposable cassette. The final length of tubing length (2–D) provides the fluid pathway from the cassette to the waste container. The Single Suction tube set does not have the “Y” fork on the suction control line.

The Smith & Nephew DYONICS 25 Day Tube Set (REF 7211007) and DYONICS 25 Patient Tube Set (REF 7211008) work together to provide a way to change patient tubing between procedures while retaining the cassette and irrigation inflow tubing (Figure 3). The first length of tubing provides an inflow pathway from an irrigation bag to the cassette (3-A). The second (blue) length of tubing (3–B) delivers fluid from the cassette through the inflow cannula into the joint space. This second length terminates in a Luer connector that allows the Patient tube set to be changed between procedures (3–B & C).

B

C A

Figure 3. DYONICS 25 Day Tube/Patient Tube Sets

B

WARNING: The Smith & Nephew DYONICS 25 Day Tube Set is to be used for one surgical day only. Do not resterilize. Do not use the Day Tube Set for more than one surgical day.

D

Note: If using the Smith & Nephew Day Tube Set (REF 7211008), the user must supply an independent outflow line (if required).

C

A

Figure 2. DYONICS 25 Inflow/Outflow Tube Set, Forked Suction

10

1061600 Rev. F

Smith & Nephew DYONICS 25 Fluid Management System Operations/Service Manual

PSOR206

System Components (continued)

Smith & Nephew DYONICS™ 25 Wireless Remote Control (optional)

Smith & Nephew DYONICS 25 Remote Control (optional)

The Smith & Nephew DYONICS 25 Wireless Remote Control (REF 72200891) is an infrared, hand-held device used to operate the DYONICS 25 System remotely (Figure 4). Power is supplied by two standard AA alkaline batteries. The remote control has controls for both inflow and outflow. The inflow controls are used to start and stop the pump, increase and decrease pressure, increase and decrease flow rate limit, and start and stop the lavage cycle. The outflow controls are used to open and close the Suction Settings screen and adjust the suction settings.

The Smith & Nephew DYONICS 25 Remote Control (REF 72201017) is a hand-held device connected to the front panel of the control unit by a cable (Figure 5). The remote control is used to start and stop the pump, increase and decrease pressure, increase and decrease flow rate limit, and start and stop the lavage cycle. The DYONICS 25 remote control cable is used to connect the remote to the DYONICS 25 System remote control connection port (Figure 7). When the DYONICS 25 remote is connected to the control unit, the remote control connected icon is displayed above the LCD Message Box.

Figure 4. DYONICS 25 Wireless Remote Control

Figure 5. DYONICS 25 Remote Control

Smith & Nephew DYONICS 25 Fluid Management System Operations/Service Manual

1061600 Rev. F

11

PSOR206

System Components (continued)

Smith & Nephew LEVELERT™ II Fluid Level Sensor (optional) The Smith & Nephew LEVELERT II Fluid Level Sensor (REF 7211011) alerts operating room personnel when the fluid level in an irrigant bag has reached a predetermined amount (Figure 6). Audio and visual signals from the LEVELERT II sensor indicate the need for bag replacement. The fluid level that triggers the alarm is adjustable. See the Instructions for Use (REF 1061573) included with the LEVELERT II sensor for information specific to the sensor.

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

Use with Non-Smith & Nephew Shavers The DYONICS 25 System may be used with any arthroscopic shaver. However, only by connecting the DYONICS 25 System to the DYONICS POWER, EP-1 or PS3500EP Shaver Systems can the automatic suction control feature be used. Without a Smith & Nephew DYONICS POWER, EP-1 or PS3500EP Shaver System, suction will have to be manually adjusted using the LCD touch screen.

Smith & Nephew Procedure Carts (optional) The Smith & Nephew Procedure Cart (REF 7211014) is intended to be used as a mobile platform for storing and using arthroscopic equipment. The cart has three shelves, with adjustable middle and bottom shelves, a wire drawer, a left- or right-sided IV pole, and wheels with wheel locks. Arthroscopy equipment can be securely attached to each shelf using either a centrally located screw.

Figure 6. LEVELERT II Fluid Level Sensor

The Smith & Nephew Procedure Cart with Transformer (REF 72200747) includes an isolation transformer and power strip in addition to the standard cart features.

Smith & Nephew DYONICS™ 25 System Shaver Interface Cable (optional)

See the Instructions for Use (REF 10600016) included with the Procedure Cart for information specific to the cart.

The Smith & Nephew DYONICS 25 Fluid Management System is designed for use with the Smith & Nephew DYONICS POWER, Smith & Nephew DYONICS EP-1 or Smith & Nephew DYONICS PS3500EP Shaver Systems to offer automatic suction control.

Accessories See the “Ordering Information” section of this manual for more information on tube sets, remote controls, fluid level sensors, cannula adaptors, and shaver interface cables.

The Shaver Interface Cable (REF 91000268) connects the Smith & Nephew DYONICS 25 System Control Unit to the Smith & Nephew DYONICS POWER, EP-1™, or PS3500EP™ Shaver Control Units.

12

1061600 Rev. F

Smith & Nephew DYONICS 25 Fluid Management System Operations/Service Manual

PSOR206

Unpacking and General Inspection

Unpacking and General Inspection Carefully unpack and inspect all components shipped with your Smith & Nephew DYONICS™ 25 Fluid Management System (REF 72200207). 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. Each DYONICS 25 System contains the following:

International Fluid Management System Each International Smith & Nephew DYONICS 25 Fluid Management System contains the following: 1 ea

REF 7211010 Smith & Nephew DYONICS 25 Fluid Management System Control Unit

1 ea

REF 91000268 DYONICS 25 Shaver Interface Cable

1 ea

Hospital-grade power cord, countryspecific

1 ea

REF 91000290 Biomed Test Key

1 ea

REF 1061600 Smith & Nephew DYONICS 25 Fluid Management System Operations/ Service Manual, countryspecific version

1 ea

REF 10600054 Smith & Nephew DYONICS 25 Fluid Management System Quick Start Guide, country specific version

U.S. Fluid Management System 1 ea

REF 7211010 Smith & Nephew DYONICS 25 Fluid Management System Control Unit

1 ea

REF 91000268 DYONICS 25 Shaver Interface Cable

1 ea

REF 8005600 Hospital-grade power cord

1 ea

REF 91000290 Biomed Test Key

1 ea

REF 1061600 Smith & Nephew DYONICS 25 Fluid Management System Operations/Service Manual, English language version

1 ea

Additional accessories may include: REF 72201017 Smith & Nephew 1 ea DYONICS 25 Remote Control (optional)

REF 10600054 Smith & Nephew DYONICS 25 Fluid Management System Quick Start Guide

1 ea

REF 72200891 Smith & Nephew DYONICS 25 Wireless Remote Control (optional)

Additional accessories may include: 1 ea REF 72201017 Smith & Nephew DYONICS 25 Remote Control (optional)

2 ea

REF 7211011 Smith & Nephew LEVELERT II Fluid Level Sensors (optional)

1 ea

REF 72200891 Smith & Nephew DYONICS 25 Wireless Remote Control (optional)

2 ea

REF 7211011 Smith & Nephew LEVELERT™ II Fluid Level Sensors (optional)

1 ea

REF 7211014 Smith & Nephew Procedure Cart (optional)

1 ea

REF 72200747 Smith & Nephew Procedure Cart with Transformer (optional)

Smith & Nephew DYONICS 25 Fluid Management System Operations/Service Manual

1061600 Rev. F

13

PSOR206

Front Panel Layout

*smith&nephew

DYONICS™ 25 Fluid Management System

1 4

2

5 3

Figure 7. Smith & Nephew DYONICS™ 25 Fluid Management System front panel

Front Panel Control/ Connection/Display

Function

1 Power up/power down button

Initiates the power up/power down procedure.

2.LCD touch/display screen

Provides specific controls for operating the pump and changing the system and pump settings. These controls are covered in detail in their respective sections of this manual. Active controls vary based on the installed tube set. The DYONICS 25 Control Unit LCD touch screen also provides all of the system displays. Display screens vary based on the installed tube set. The screen color settings will change based on the cannula flow rate selected: High Flow = yellow; Medium Flow = green; Low Flow = blue. 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.Remote control connection port

Receptacle for the remote control cable.

4.Tube set cassette lock/release

Locks/releases the tube set cassette in the cassette slot.

5.Tube set cassette slot

Secures the tube set cassette to the control unit.

14

1061600 Rev. F

Smith & Nephew DYONICS 25 Fluid Management System Operations/Service Manual

PSOR206

Rear Panel Layout

6

5

4

1

3

2

7

8

9

Figure 8. Smith & Nephew DYONICS™ 25 Fluid Management System rear panel

Rear Panel Controls and Function Connections 1. Fuse access door

Provides user access for fuse replacement. Use appropriate fuses to avoid hazards. See Technical Specifications.

2. Power cord connector

This receptacle is an integral part of the power input module and accommodates the hospital-grade power cord accessory.

3. Equipotential compensator terminal (case ground)

Used to bring other equipment into the same case potential as the device.

4. Bidirectional port

Serial communication connection to Digital O.R. Control Center.

5. Serial ports A and B

Not currently used.

6. Shaver port

Serial communication connection to DYONICS POWER Shaver System.

7. Exhaust fan

Provides system cooling.

8. Ethernet port

Ethernet network connection.

9. USB ports (1-2-3)

For authorized service use only.

Smith & Nephew DYONICS 25 Fluid Management System Operations/Service Manual

1061600 Rev. F

15

PSOR206

Side Panel Layout/Other Indicators

1

Figure 9. Smith & Nephew DYONICS™ 25 Fluid Management System side panel layout

Side Panel Layout 1. Pressure transducers – measure the fluid pressure in the cassette.

Other Indicators Warning messages – the Message Box turns yellow and displays a flashing warning message. Some warning messages may be accompanied by a beeping alarm. Warning messages are listed in the Warning Messages Table. Fault messages – when the system encounters a system fault it stops the pump, clears the current screen, and displays “SYSTEM ERROR.” Fault messages are listed in the Fault Messages Table.

16

1061600 Rev. F

Smith & Nephew DYONICS 25 Fluid Management System Operations/Service Manual

PSOR206

Remote Control Layouts Wireless Remote Control Controls

Function

Outflow Controls 1. Suction (Shaver ON) buttons

Increases/decreases the Shaver ON suction setting. These buttons also may be used to adjust the suction setting for the Shaver Not Detected Mode.

2 Set Suction/Done button

Opens the Suction Settings screen. Closes the Suction Settings screen and saves any changes.

3.Suction (Shaver OFF) buttons

Increases/decreases the Shaver OFF suction setting. These buttons also may be used to adjust the suction setting for the Shaver Not Detected Mode.

Inflow Controls

Figure 10. Wireless Remote Control

4.Pressure buttons

Increases/decreases the pressure setting.

5.Lavage Start/Stop button

Starts/stops the Lavage cycle.

6.Flow Limit buttons

Increases/decreases the flow rate limit setting.

7. Start button

Starts the pump.

8.Stop button

Stops the pump.

Remote Control Controls

Function

1. Pressure buttons

Increases/decreases the pressure setting.

2 Lavage Start/Stop button

Starts/stops the Lavage cycle.

3.Flow Limit buttons

Increases/decreases the flow rate limit setting.

4.Start button

Starts the pump.

5.Stop button

Stops the pump.

Figure 11. Remote Control

Smith & Nephew DYONICS 25 Fluid Management System Operations/Service Manual

1061600 Rev. F

17

PSOR206

Recommended System Configuration

IEC 60601-1-1 Compliant System Configuration Figure 12 indicates a system configuration that complies with IEC 60601-1-1 requirements.

•

WARNING: If this unit is configured as part of a system, the entire system should be tested for compliance with IEC 60601-1-1. •

If the leakage current of the configured system exceeds the limits of IEC 60601-1-1, install an appropriately rated UL 60601-1/ IEC 60601-1 approved isolation transformer and retest the system.

The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include: – Use of the accessory in the patient vicinity. – Evidence that the safety certification of the accessory has been performed in accordance with the appropriate UL 60601-1/IEC 60601-1 and/or IEC 60601-1-1.

Wired Remote Control

Smith & Nephew DYONICS™ 25 Fluid Management System Control Unit REF 7211010

VAC

Shaver connection port

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

VAC

Smith & Nephew Procedure Cart with Transformer REF 72200747 11.75A, 120 VAC, 60 Hz

Handpiece

Wall receptacle, circuit 1 120 VAC 15A 50/60 Hz

Footswitch RF Handpiece

Smith & Nephew VULCAN Generator REF 7210812

VAC

Footswitch

Figure 12. IEC 60601-1-1 System Configuration

18

1061600 Rev. F

Smith & Nephew DYONICS 25 Fluid Management System Operations/Service Manual

PSOR206

Preoperative Setup

Cannulas Use Table 1 to determine the appropriate cannula setting. WARNING: Improper cannula setting can lead to inaccurate pressure settings, pressure and flow rate fluctuations, and overpressurization of the joint. CAUTION: In all cases, the judgment of the physician (in the best interest of the patient) may take precedence over the instructions in this manual.

Table 1: Suggested DYONICS™ 25 cannula settings based on cannula and arthroscope size

Inflow Cannula Size

Arthroscope Size No scope Inflow Cannula Only

1.9 mm

2.7 mm

4.0 mm

<2.5 mm

High Flow

Low Flow

N/A

N/A

2.5–3.0 mm

High Flow

Medium Flow

Low Flow

N/A

3.1–4.0 mm

Not Recommended

Medium Flow

Medium Flow

N/A

4.1–4.5 mm

Not Recommended

High Flow

High Flow

Low Flow

4.6–5.0 mm

Not Recommended

Not Recommended

High Flow

Medium Flow

>5.0 mm

Not Recommended

Not Recommended

Not Recommended

High Flow

*

* Exceptions: Some cannulas larger than 5.0 mm have lower flow capacity and require the Medium Flow setting.

Smith & Nephew DYONICS 25 Fluid Management System Operations/Service Manual

1061600 Rev. F

19

PSOR206

Preoperative Setup

Preoperative Setup Control Unit Setup 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. 1. Plug the control unit power cord into the rear panel power cord connector and a grounded AC power source. WARNING: Check that the electrical equipment is properly grounded (i.e., plugs contain a ground prong). The device must be plugged into a hospital-grade AC outlet.

Note: Ensure that no remote buttons are being pressed while the cable is connected. Depressed buttons during cable connection will trigger a warning message. Note: The remote can be plugged in after the control unit is powered on. 3. Press the power up/power down button to turn the control unit on. 4. The system will briefly display the Smith & Nephew screen (Figure 14) before displaying the Load Cassette screen (Figure 15). If a cassette is already loaded, the control unit will open the appropriate operating screen for the attached cassette.

Note: The control unit should be on the same horizontal plane as the operative joint. Adjust the patient and/or pump height to align the operative joint with the DYONICS™ 25 pump (Figure 13). 2. Optional: Connect the remote control cable to the remote control cable connector on the front panel of the control unit. WARNING: The DYONICS 25 Remote Control is shipped non-sterile. To use the remote in the sterile field the remote and its cord must be securely enclosed in a sterile bag using aseptic techniques in accordance with standard operating room procedures.

Figure 14. Smith & Nephew screen

3000 2750 2500 2250 2000 1750 1500 1250 1000 750 500

18–24"

250

Figure 15. Load Cassette screen

x"

x"

Figure 13. Pump/joint alignment

20

1061600 Rev. F

Smith & Nephew DYONICS 25 Fluid Management System Operations/Service Manual