DYONICS 25 Fluid Management System Operations and Service Manual Rev B

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: Danger 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 icon

Serial Port

Shaver icon

Bidirectional port

Pump icon

Shaver port

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Glossary of Symbols (continued) USB Port

Ethernet Port

Single use only. Do not reuse.

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

Keep Dry

This Way Up

Fragile; handle with care

Temperature Range

Humidity

Expiration Date

Lot Number

Latex free

DEHP free

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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 Introduction...6 Indications for Use...6 Contraindications...6 Warnings...7 Precautions...7 System Components...9 Disposable Tube Sets...9 Inflow/Outflow Tube Sets...9 Inflow Only Tube Set...10 Day Tube Set...10 Smith & Nephew DYONICS™ 25 System Shaver Interface Cable...10 Use with Non-Smith & Nephew Shavers...10 Accessories...10 Unpacking and General Inspection . . .11 U.S. Fluid Management System...11 International Fluid Management System...11 Front Panel Layout...12 Rear Panel Layout...13 Side Panel Layout...14 Other Indicators...14 Recommended System Configuration .15 Preoperative Setup...16 Cannulas...16 Control Unit Setup...17 Inflow Tube Set Preparation...17 Day Tube Set/Patient Tube Set Preparation...18 Inflow/Outflow Tube Set Preparation . .18 Shaver Control Unit Integration...20 Settings...20 Change the system language...20 Review System Information...21 Custom Settings...21 Program custom pressure settings .21 Program custom flow rate settings .22 Program custom cannula settings .22

Program custom suction settings . .22 Custom Mode...22

Technical Specifications...42

Operation...24 Replacing Irrigation Bags During Surgery...24 Repriming Cassette...24 Converting to a Gravity-Fed System . .24 Directing Suction...24 Adjusting Suction Rate...24 Cannula Selection...24 Cannula Technique...25 Operational modes...25 Inflow Tube Set Mode...25 Inflow/Outflow Tube Set, Shaver Detected Mode...26 Inflow/Outflow Tube Set, Shaver Not Detected Mode...28 Day Tube Set Mode...29

Guidance and Manufacturer’s Declaration - Electromagnetic Emissions...45

Cleaning and Sterilization...32 Smith & Nephew DYONICS 25 Fluid Management System...32 Smith & Nephew DYONICS 25 Tube Sets...32 Smith & Nephew DYONICS 25 Day Tube Set...32 Troubleshooting...33 Observed Problems...33 Observed Problems Table...33–35 Warning Message Table...36 Fault Message Table...37

Ordering information...44

Guidance for Separation Distances...45 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity...46–47 Warranty...Back Cover Service Replacement Program...Back Cover Repair Service Program...Back Cover TABLES Table 1: DYONICS 25 cannula settings based on cannula and arthroscope size...16 Table 2: Minimum and maximum flow rates for cannulas...22 Warning Message Table...36 Fault Message Table...37 Applied Pressure Table...41 Pressure and Flow Rate Limit Settings Table...43 Suction Settings – Shaver Detected Table...43 Suction Settings – Shaver Not Detected Table...43

Service...38 Service Philosophy...38 Electrical Interference...38 Environmental Protection...38 Maintenance...39 Replacing Fuses...39 Replacing / returning worn or defective equipment or parts...39 Preventive Maintenance...39 Biomed Test Mode...40

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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 shaver system interface cable, 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 DYONCIS 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 Powered Instrumentation System, Smith & Nephew EP-1™ Endoscopic Powered Instrument System, or Smith & Nephew PS3500EP™ Arthroscopic Surgical System. When the DYONICS 25 System is used with the Smith & Nephew DYONICS Power, EP-1 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

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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 STOP button. Drain the fluid from the joint. • 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.

• Improper cannula selection 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.

Precautions • U.S. Federal law restricts this device to sale by or on the order of a physician. • Prior to use, examine the device for possible damage to assure proper functioning. • Check the LCD display screen to ensure that the proper settings are displayed prior to beginning any procedure. • Use only the power cord and connector specified for this unit. • 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.

• 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.

• Increase the separation between the pieces of equipment.

• 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.

• Consult a biomedical engineer.

• 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.

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

• Connect the pieces of equipment into different outlets or circuits. • 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.”

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Precautions (continued)

• 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.

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. • 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.

• Handle the unit with care. If the unit is dropped or damaged in any way, it must be returned immediately for service. • Use only one finger at a time when operating the LCD touch screen. Multiple, simultaneous finger presses can result in unintended changes to settings and erroneous control inputs. • Only use 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 IEC60601-1 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

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System Components

System Components

Inflow/Outflow Tube Sets

The Smith & Nephew DYONICS™ 25 Tube Sets are used to deliver irrigation fluid to the joint. 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 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 1). One length of tubing (1–A) serves as the inflow pathway from an irrigation bag to the cassette. The second (blue) length of tubing (1–B) delivers fluid from the cassette through the inflow cannula into the joint space. The third length of tubing (1–C) directs outflow from the joint to the suction control line contained in the disposable cassette. The final length of tubing length (1–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 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 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 type, starting and stopping lavage mode, and restoring system defaults. 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. 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 to Medical Device Directive 93/42/EEC.

C B A

D

Figure 1: DYONICS 25 Inflow/Outflow Tube Set, Forked Suction

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

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System Components (continued)

Inflow Tube Set The Smith & Nephew DYONICS 25 Inflow Tube Set (REF 7211004) has two lengths of tubing (Figure 2). The first length of tubing provides an inflow pathway from an irrigation bag to the cassette (2-A). The second (blue) length of tubing (2–B) delivers fluid from the cassette through the inflow cannula into the joint space.

Smith & Nephew DYONICS™ 25 System Shaver Interface Cable 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. 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 Unit.

B

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

A Figure 2: DYONICS 25 Inflow Tube Set

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

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.

Accessories See the “Ordering Informaton” section of this manual for more information on tube sets, cannula adaptors, and shaver interface cables.

B

C A

Figure 3: DYONICS 25 Day Tube/Patient Tube Sets

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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 72200206). 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. You should have received the following:

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

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

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

Smith & Nephew DYONICS 25 Fluid Management System Operations/ Service Manual, country-specific version

1 ea

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

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Front Panel Layout

*smith&nephew

DYONICS™ 25 Fluid Management System

1 4

2

5 3

Figure 1. 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 running 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 size selected: Large Diameter = yellow; Standard = green; Small Joint = 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.

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Rear Panel Layout

1 A

6

7

3

B

5

4

2 T 4.0AL / 2 5 0 V

3

8

1

9

2

XXXX

Figure 2. 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 & 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.

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Side Panel Layout/Other Indicators

1

Figure 3. Smith & Nephew DYONICS 25 Fluid Management System side panel layout

Side Panel layout 1. Pressure transducers – measures the fluid pressure in the cassette.

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

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Recommended System Configuration

IEC 60601-1-1 Compliant System Configuration

•

Figure 8 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.

Corded 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

IEC 60601 Compliant Multiple Socket Outlet REF 90500169 15A, 120 VAC, 50/60 Hz

Handpiece

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

Smith & Nephew Procedure Cart REF 7211014

Footswitch RF Handpiece

Smith & Nephew VULCAN Generator REF 7210812

Footswitch

VAC Wall receptacle, circuit 2 120 VAC 15A 50–60 Hz

Figure 8: IEC 60601-1-1 System Configuration

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Preoperative Setup

Cannulas Use the Table 1 to determine the appropriate cannula setting. WARNING: Improper cannula selection 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: DYONICS 25 cannula settings based on cannula and arthroscope size.

Inflow Cannula Size

Arthroscope Size

16

No scope Inflow Cannula Only

1.9 mm

2.7 mm

4.0 mm

<2.5 mm

Large Diameter

Small Joint

N/A

N/A

2.5–3.0 mm

Large Diameter

Standard

Small Joint

N/A

3.1–4.0 mm

Not Recommended

Standard

Standard

N/A

4.1–4.5 mm

Not Recommended

Large Diameter

Large Diameter

Small Joint

4.6–5.0 mm

Not Recommended

Not Recommended

Large Diameter

Standard

>5.0 mm

Not Recommended

Not Recommended

Not Recommended

Large Diameter

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Preoperative Setup

will open the appropriate operating screen for the attached cassette.

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.

Figure 10. Smith & Nephew screen

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 9). 2. Press the Power Up/Power Down button to turn the control unit on. 3. The system will briefly display the Smith & Nephew screen (Figure 10) before displaying the Load Cassette screen (Figure 11). If a cassette is already loaded, the control unit

3000

Figure 11. Load Cassette screen

WARNING: 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.

2750 2500 2250 2000 1750 1500 1250 1000 750 500

18–24"

250

x"

x"

Figure 9. Pump/joint alignment

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Preoperative Setup (continued)

Inflow Tube Set (REF 7211004) Preparation 1. Using aseptic technique, open the sterile packaging containing the disposable tube set and transfer all tubing into the surgical field. 2. Leave the blue inflow tubing coil in the surgical field. Transfer the cassette and remaining tubing coil to a nurse outside the surgical field. 3. Peel the wrapper from the blue inflow tubing coil. 4. Load the cassette into the control unit’s cassette slot. CAUTION: Confirm that the “I” Tube Set icon appears in the message box. If the icon does not appear or an incorrect icon appears, see the “Troubleshooting” section. Note: To remove the cassette, turn the control unit on and press the cassette release tab to remove the cassette from the cassette port. The cassette release tab is located near the lock icon on the front of the control unit. 5. Close all tubing clamps and spike the irrigation bag. Note: If using Smith & Nephew Inflow Tube Set (REF 7211004), the user must supply an independent outflow line. Note: Irrigation bags should be hung 18–24 inches above the control unit. 6. Before priming, place the blue inflow tubing in a sterile basin or patient drape to collect fluid. 7. Open all clamps and press the Start button to prime the tubing and cassette. Ensure all air is purged from the tubing and cassette. 8. Close the blue inflow clamp. 9. Attach the blue inflow tubing line to the inflow cannula. Open the clamp when ready for fluid delivery. Note: If using a Smith & Nephew INTELIJET™ Cannula, use the Smith & Nephew DYONICS 25 Luer-to-Colder Adaptor (REF 7211009).

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Note: The DYONICS 25 System suction settings are not active on the Operations screen when using the Smith & Nephew Day Tube Set and the Smith & Nephew Inflow Tube Set.

Day Tube Set (REF 7211007) /Patient Tube Set (REF 7211008) Preparation 1. Using aseptic technique, open the sterile packaging containing the disposable Day Tube Set and load the cassette into the control unit’s cassette slot. WARNING: The Smith & Nephew Day Tube Set is to be used for one surgical day. Do not resterilize. Do not reuse the Day Tube Set for more than one surgical day. CAUTION: Confirm that the “DT” Tube Set icon appears in the message box. If the icon does not appear or an incorrect icon appears, see the “Troubleshooting” section. Note: To remove the cassette, turn the control unit on and press the cassette release tab to remove the cassette from the cassette port. The cassette release tab is located near the lock icon on the front of the control unit. 2. Close all tubing clamps and spike the irrigation bag. Note: Irrigation bags should be hung 18–24 inches above the control unit. 3. Using aseptic technique, open the pouch containing the disposable Patient Tube Set and transfer the blue patient tubing into the sterile field. Locate the Patient Tube Set Luer cap bag and transfer it to the circulator for post-procedure use. 4. Using aseptic technique, remove the sterile Luer cap from the Day Tube Set inflow tubing and discard it. Note: The Day Tube Set Luer cap will have been removed for the O.R.’s first procedure. The Patient Tube Set Luer Cap will be used to cap the Day Tube set inflow tubing at the end of each subsequent procedure.

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

Preoperative Setup (continued)

5. Peel the wrapper from the blue patient tubing coil and pass the Day Tube connector end of the blue patient tubing out of the sterile field. Using aseptic technique, connect it to the Day Tube blue inflow tubing. Note: If using Smith & Nephew Day Tube Set (REF 7211008), the user must supply an independent outflow line. 6. Before priming, place the blue inflow tubing in a sterile basin or patient drape to collect fluid. 7. Open all clamps and press the Start button to prime the tubing and cassette. Ensure all air is purged from the tubing and cassette. 8. Close the sterile blue inflow clamp. 9. Attach the blue inflow tubing line to the inflow cannula. Open the clamp when ready for fluid delivery. Note: If using a Smith & Nephew INTELIJET™ Cannula, use the Smith & Nephew DYONICS 25 Luer-to-Colder Adaptor (REF 7211009). 10.At the end of the procedure, remove and discard the blue patient tubing. When removing the Patient Tube Set at the end of a procedure, locate and attach the Patient Tube Set Luer Cap to the Day Tube Set inflow tubing to ensure a sterile connection between the Day Tube Set and Patient Tube Set used in the next procedure. Note: Prior to each new procedure, purge the air from the new Patient Tube Set. Note: The DYONICS 25 System suction settings are not active on the Operations screen when using the Smith & Nephew Day Tube Set and the Smith & Nephew Inflow Tube Set.

Inflow/Outflow Tube Set (REF 7211005, 7211006) Preparation

Transfer the cassette and remaining tubing coils to a nurse outside the surgical field. Note: When using Smith & Nephew Inflow/Outflow, Forked Suction Tube Set (REF 7211006), identify the forked suction tubing in the surgical field. The length of tubing with the red connector is attached to a powered instrument or outflow instrument. The second suction tubing fork may be connected to an outflow cannula, used to evacuate the patient drape, or clamped off if not used. Note: When using Smith & Nephew Inflow/Outflow, Single Suction Tube Set (REF 7211005), identify the single suction line and connect it to a shaver, outflow instrument, or operative cannula. 3. Peel the wrapper from the irrigation tubing coil. 4. Load the cassette into the control unit’s cassette slot. CAUTION: Confirm that the “I/O” Tube Set icon appears in the message box. If the icon does not appear or an incorrect icon appears see, the “Troubleshooting” section. Note: To remove the cassette, turn the control unit on and press the cassette release tab to remove the cassette from the cassette port. The cassette release tab is located near the lock icon on the front of the control unit. 5. Close all tubing clamps and spike the irrigation bag. Note: Irrigation bags should be hung 18–24 inches above the control unit. 6. Connect the suction tubing coil to standard hospital suction. 7. Before priming, place the blue inflow tubing in a sterile basin or patient drape to collect fluid.

1. Using aseptic technique, open the sterile packaging containing the disposable tube set and transfer all tubing into the surgical field.

8. Open the white and blue clamps (red clamps remain closed) and press the Start button to prime the tubing and cassette. Ensure all air is purged from the tubing and cassette.

2. Leave the blue inflow tubing coil and the suction tubing coil in the surgical field.

9. Close the blue inflow clamp.

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Preoperative Setup (continued)

10.Attach the blue inflow tubing line to the inflow cannula. Open the clamp when ready for fluid delivery. Note: The DYONICS 25 System suction settings are not active on the Operations screen when using the Smith & Nephew Day Tube Set and the Smith & Nephew Inflow Tube Set.

Settings The DYONICS 25 System can be configured to run with custom settings. The Settings button is active whenever the pump is not running. To open the Settings screen (Figure 12) immediately after startup, press the Settings button on the Load Cassette screen.

Note: If using a Smith & Nephew INTELIJET™ Cannula, use the Smith & Nephew DYONICS 25 Luer-to-Colder Adaptor (REF 7211009).

Shaver Control Unit Integration To integrate the Smith & Nephew DYONICS™ 25 System with a Smith & Nephew DYONICS Power, EP-1, or PS3500EP Arthroscopic Surgical Shaver System: 1. Assure that the shaver system has been set up per standard setup procedures. (Refer to your Smith & Nephew DYONICS Power, EP-1, or PS3500EP Operations/Service Manual). 2. Set the shaver suction lever to the MAX position. 3. Assure that the communications cable is connected into the Shaver Control ports on the rear of the shaver system and the DYONICS 25 control unit. 4. Shaver suction settings are factory preset to 100% outflow while shaver is on and to 50% outflow when shaver is idle. To adjust the suction settings press the Set Suction button while the pump is running. See the “Inflow/Outflow Tube Set, Shaver Detected Mode” section of this manual for more information.

Figure 12. Settings screen

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.

Change the system language Press the Settings button to open the Settings screen. Press the Language button to open the Language screen (Figure 13).

Note: To adjust the custom shaver suction levels, see the “Settings” section of this manual for instructions. Figure 13. Language screen

Select the language you want the system to display and press the corresponding button. The system displays a confirmation message “Are you sure you want {selected language} as the system language?” (Figure 14). Press the Yes button to confirm and change the system 20

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language. Press the No button to cancel and leave the system language unchanged. Press the Done button to return to the Settings screen.

Figure 16. Custom Settings screen

Program custom pressure settings Figure 14. Language change confirmation message

Review System Information Press the Settings button to open the Settings screen. Press the System Information button to open the System Information screen (Figure 15). The System Information screen displays the product name, model number, software version, application version, and motor controller version for the DYONICS 25 System. Press the Done button to return to the Settings screen.

Press the Pressure button to open the Custom Pressure mmHg settings screen (Figure 17). A custom pressure setting can be entered for each of the three cannula sizes: small joint, standard, and large diameter. For each cannula size, press and hold the Up or Down buttons to change the pressure setting. Pressure cannot be set lower than 10 mmHg or higher than 150 mmHg.

Figure 17. Custom Pressure mmHg settings screen

Figure 15. System Information screen

Custom Settings Press the Settings button to open the Settings screen. Press the Custom Settings button to open the Custom Settings screen (Figure 16). The system can be programmed with custom settings for pressure, flow rate limit, suction/blade speed, and cannula type. When in Custom Mode, the system will default to the programmed custom settings.

Note: The DYONICS 25 control unit assumes the patient joint is at the same height as the pressure transducers (see Figure 9). If the joint is above or below the transducer, a constant offset (less than or more than, respectively) to pressure occurs in the joint. This pressure offset is due to difference in height, and not due to control unit function. The offset value is approximately 22 mmHg per foot difference between joint and transducer height. Press the Set button to store the custom pressure settings in system memory and return to the Custom Settings screen.

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