Fluid Management System Operations Service Manual Rev H Sept 2010

Glossary of Symbols

Glossary of Symbols Pressure

Total volume

EQUIPMENT CLASSIFICATION -Patient Isolation Type BF Applied Part

Start/Stop

Reset button

Alternating current

Flow

Service required

Keep dry

Up and Down buttons

Equipotentiality

This end up

Menu button

Scope

Fragile; handle with care

On/Off button

Drape

Indicates explosion risk in the presence of flammable anesthetics

Power plug

Handpiece

UL Classification

Fluid deficit

EU: Not for general waste

Fluid deficit rate alarm

Latex free

Smith & Nephew Hysteroscopic Fluid Management System

Operations/Service Manual

1061372 Rev. H

3

Preface/Table of Contents

Preface This manual contains information required to operate and maintain the Smith & Nephew Hysteroscopic Fluid Management System. It is essential that all the information in this manual be read and understood before using or maintaining the system.

Table of Contents Preface... 4 Table of Contents... 4 Device Description... 5 Indications for Use... 5 Contraindications... 5 Warnings... 5 Precautions... 7 Unpack the Components... 8 System Components... 8 Assemble the Components... 9 Assemble the Roller Base to the Stand . 9 Assemble the Carrier Plate to the Support Pole... 9 Assemble Remaining Components... 10 Control Unit Front Panel... 11 Control Unit Rear Panel... 12 Fluid Monitor Display... 12 Recommended System Configuration . 13 Preoperative Setup... 14

Power Supply Connection... 14 Safety Plug... 14 U.S. Operation... 14 Potential Equalization... 14 Hang the Fluid Bags... 14 Connect Tube Sets to Devices... 14 Tube Set Connections Using the TRUCLEAR™ System... 15 Tube Set Connections Using the TRUCLEAR Hysteroscopic Instrument Sets... 16 Tube Set Connections Using the Resectoscope/Hysteroscope... 17 Connect the Inflow Tube Set... 18 Insert the Roller Tubing Section... 18 Connect to the Fluid Bags... 19 Connect to the Hysteroscope/ Resectoscope... 19

Connect the Smith & Nephew Outflow Tube Set... 19 Connect the Drape Outflow Tubing (Blue Connector)... 19 Operative Hysteroscopy Procedure Using the Smith & Nephew TRUCLEAR System... 19 Connect the Handpiece Tubing (White Connector)... 19 Connect the Outflow Tubing (Yellow Connector)... 19 Diagnostic Hysteroscopy Procedure . . 19 Connect the Outflow Tubing (Yellow Connector)... 19

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1061372 Rev. H

Resectoscopy Procedure (Regulated Suction)... 20 Connect the Resectoscope Outflow Tubing (Yellow Connector)... 20 Verify Tubing Connections... 20 Confirm Scope Connection... 20 Technical Overview... 20 Operation... 20

Plug into a Power Source... 20 Turn Pump Control Unit On... 20 Adjust Pump Pressure and Flow Rate ... 21 Pump Pressure... 21 Flow Rate ... 21 Instrument Detection... 21 Start Pump Operation... 21 Stop Pump Operation ... 21 Restart Pump Operation ... 21 Pump Control Unit Functions... 22 Pressure Readings and Controls... 22 Default Settings... 22 IU PRESSURE Display... 22 SET PRESSURE Display ... 22 MAX FLOW Display... 22

Fluid Monitor Unit Functions ... 22 Fluid Monitoring System Capacity . . . 22

Bag and Canister Recognition System... 23 Hang a Bag During the Procedure... 23 Turn the Control Unit Off... 23 System Safety Features... 23 Intrauterine Pressure Exceeds Set Pressure by 20 mmHg... 23 Intrauterine Pressure Below Set Pressure by 20 mmHg... 23 Intrauterine Pressure 200 mmHg ... 23 Pressure Chamber not Secured... 23 Pressure Measuring System Errors ... 23 Control Unit Defect... 23 Pressure Control After Restart . . 23 Deficit Threshold ... 23

Increase of 100 ml After Exceeding the Deficit Threshold... 24 Deficit Rate Larger than 300 ml/min... 24 Defective Scale... 24 100 mmHg Safety Limit... 24 Fluid Monitor Unit Overload... 24 Access the User Menu... 24 Available user menu levels and settings ... 24 Cleaning... 25 Clean the Control Unit... 25 Clean the Fluid Monitor Unit and Stand Assembly... 25 Clean the Vacuum Regulator ... 25 Service... 25 Service Philosophy ... 25 Replace Fuses... 25 Electrical Interference... 26 Environmental Protection... 26

Maintenance... 26 Preventative Maintenance... 26 Recommended Annual Safety Testing... 26 Preparation... 26 Dielectric Strength Test ... 26 Earth Leakage Current Test ... 26 Protective Earth Test... 26 Recommended Annual Performance Testing... 26 Basic Function Test... 26 Stand System Disassembly... 29 Troubleshooting... 30 Troubleshooting Flow Diagram... 32 Technical Specifications... 33 Ordering Information... 33 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions... 34 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity... 35 Guidance for Separation Distances . . . 37 Glossary... 38 Warranty... Back Cover Service Replacement Units... Back Cover Warranty... Back Cover Repair Service Program... Back Cover

Smith & Nephew Hysteroscopic Fluid Management System

Operations/Service Manual

Device Description/Indications for Use/Contraindications/Warnings

Device Description The Smith & Nephew Hysteroscopic Fluid Management System consists of an irrigation pump with a fluid monitor unit used for hysteroscopic procedures. The product is designed to pump fluid and measure the amount of fluid used in these procedures.

Indications for Use The Hysteroscopic Fluid Management System is a device intended to provide liquid distension of the uterus for diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.

Contraindications Use of this device for intrauterine distension is contraindicated whenever hysteroscopy is contraindicated. Relative contraindications to endometrial ablation: surgical skill (“acute technical”). Hysteroscopic endometrial ablation, whether by laser or electrosurgery, should not be undertaken before adequate training, preceptorship, and clinical experience. Additionally, tissue sampling is required prior to destruction of the endometrium. The following are clinical conditions that can significantly complicate hysteroscopic endometrial ablation: • Adenomatous endometrial hyperplasia • Uterine leiomyoma • Severe adenomyosis • Pelvic pain (subtle PID) • Uterine anomalies Relative contraindications to hysteroscopic myomectomy: • Surgical skill (see above) • Severe anemia • Inability to circumnavigate the myoma (re: myoma size), predominantly intramural myomas with small submucous components.

Warnings • This manual does not provide a detailed description of procedure techniques, nor is it suitable for introducing a beginner to this surgical technique. Medical accessories and devices may be used only by physicians and medical assistants under the direction of a physician with the appropriate technical qualification. • Read these instructions completely prior to use. • DANGER: Risk of explosion if used in the presence of flammable anesthetics. • Condensation/water penetration: Protect the system from moisture. Do not use if moisture has penetrated the system. • To prevent electrical shock, do not open the irrigation pump control unit or the fluid monitor unit. Refer servicing to authorized service personnel. • Tube sets are provided sterile and are for single use only. Do not reuse. Do not resterilize. Prior to use, inspect the product package for signs of damage or tampering. If damaged, do not use. Discard any opened and unused product. • Work exclusively with sterile substances, sterile fluids, and sterile accessories. • The volume of the irrigation fluid entering and leaving the patient has to be strictly monitored. If a low viscosity liquid distension medium is used, intrauterine instillation exceeding 2 liters should be followed with great care due to the possibility of fluid overload. If a high viscosity fluid (e.g. Hyskon) is used, the use of more than 500 ml should be followed with great care. Refer to the labelling of the irrigation fluid used for additional information. • Only sterile saline can be used with the Smith & Nephew TRUCLEAR™ System. • The system must only be used with hysteroscopes and resectoscopes designed for the intended surgical procedure. The scopes must comply with the most recent versions of EN 60601-2-18. • 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.

Smith & Nephew Hysteroscopic Fluid Management System

Operations/Service Manual

1061372 Rev. H

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Warnings (continued)

• The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include: – Use of the accessory in the patient vicinity. – Evidence that the safety certification of the accessory has been performed in accordance with UL 60601-1/IEC 60601-1. • The instrument detection process must only be performed outside of the patient. The hysteroscope or resectoscope must be held at the same height as the height at which the procedure is to be performed. • This system is intended only for use with plastic fluid canisters and fluid bags. Glass canisters or bottles may break, and there is a risk of implosion. • Use of bags or canisters not approved for this system, or large and/or lopsided loads, may cause the device to tip over. • In the event the irrigation pump fails during a procedure, a replacement control unit and accessories should be available. • If a system deficiency is suspected, or if the system fails to monitor the indicated fluid levels, stop using the system until it has been checked by authorized service personnel. • If obvious defects are present, especially at the power cord receptacle or power cord, the control unit should not be used. • For protection against fire hazard, replace control unit fuses only with fuses of the same type and rating. • Stop the device using the Start/Stop button if the scope is changed during surgery. • Intrauterine distension can usually be accomplished with pressures in the range of 35–75 mmHg. Unless the systemic blood pressure is excessive, it is seldom necessary to use pressure greater than 75–80 mmHg. • Intrauterine pressure should be maintained as low as possible to allow adequate distension while minimizing the risk of fluid, air, and/or gas intravasation. • Fluid Overload (Hyperhydration): By passing through the uterus, irrigation fluids may end up in the blood system or in the patient’s tissue, especially in cases of overpressure, a lengthy procedure, or perforation of the uterine cavity. The physician bears responsibility for monitoring and assessment of these and all other potentially related factors. • An air embolism can be the result of air contained in the tube set. Ensure there is always fluid in the bag to prevent air from being delivered into the patient.

• It is necessary to monitor the amount of irrigation fluid left in the patient and the concentration of sodium in the blood serum. The calculation of the amount of irrigation fluid left in the patient is the physician’s responsibility. • Resetting the FLUID DEFICIT display is to be done at the physician’s discretion. • If the intrauterine pressure does not respond to an increase in set pressure, this may indicate a perforation of the uterine cavity. There is danger of internal bleeding. Examine the uterus for possible injuries. • In the event of a power outage, the deficit and inflow values are lost. • The complete fluid monitor system is composed of a scale system and a carrier plate stand, each of which includes its own components. To ensure the accuracy of fluid measurement, these individual components must not touch one another. • Fluid bags must be hung to the rear of the fluid bag deflector to allow for accurate accountability of irrigation fluid usage. • Ensure that fluid bags hang freely. They must not be supported from the bottom, or the fluid deficit will not be measured accurately. • When spiking the bag, do not pull or lift the bag as it may result in an inaccurate deficit reading. • Any contact with the scale system, including a bag or collection system canister exchange, must be performed quickly and with minimal vibration. • To ensure accurate measurements, do not place any items in areas that are weight-sensitive (fluid bag holder or top of fluid collection system canisters). • Ensure neither the power cord nor the equipotential cable touch any part of the scale system, including fluid collection system canisters. This may lead to an error in monitoring the fluid deficit. The control unit may only be operated with angular equipotential MC plugs. • Pressing the On/Off button does not disconnect the control unit from the power source. This requires removing the power plug from the rear of the control unit. • To avoid the risk of electrical shock, connect the power cord to a properly wired grounding receptacle only. • Ensure that all components are properly aligned. • Ensure that the two support poles are properly aligned with the load controller bracket and the bracket is tightened. • Ensure that the O-ring in the load controller bracket is properly seated and does not touch the scale system support pole.

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1061372 Rev. H

Smith & Nephew Hysteroscopic Fluid Management System

Operations/Service Manual

Precautions

Precautions U.S. Federal law restricts this device to sale by or on the order of a physician. • Prior to use, examine the device(s) for possible damage to assure proper functioning. If damaged, do not use. • Check all user menu settings and values. Internal standard factory settings may be changed at the physician’s discretion. The physician is responsible for all settings that pertain to his/her procedure. • Do not sterilize the control unit or fluid monitor unit. • Do not step on, stand on, or roll objects over any tubing. Avoid high traffic areas where tubing may be subjected to detachment. • Ensure that the available mains voltage matches the data listed on the label attached to the back of the control unit. Incorrect voltage can cause errors or malfunction, and may destroy the equipment. • Electrical Interference: This equipment is designed and tested to minimize interference with other electrical equipment. However, if interference occurs with other equipment it may be corrected by one or more of the following measures: – Reorient or relocate this equipment, the other equipment, or both. – Increase the separation between the pieces of equipment. – Connect the pieces of equipment into different outlets or circuits. – Consult a biomedical engineer. • Environmental Protection: This equipment contains electronic printed circuit assemblies. At the end of the useful life of the equipment it should be disposed of in accordance with any applicable national or institutional related policy relating to obsolete electronic equipment. • Electrical safety testing should be performed by a biomedical engineer or other qualified person. • The control unit or fluid monitor unit housing should not be opened except by a qualified service person. Tampering by unqualified persons can damage these devices. • Handle unit with care. If the unit is dropped or damaged in any way, it must be returned immediately for service. • The electrical safety conditions should be checked annually to ensure compliance with IEC 60601-1. • After use, tube sets may be a potential biohazard and should be handled in accordance with accepted medical practice and applicable local and national requirements.

Smith & Nephew Hysteroscopic Fluid Management System

Operations/Service Manual

1061372 Rev. H

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System Components

System Components

Unpack the Components Carefully unpack and inspect all components shipped with the Smith & Nephew Hysteroscopic Fluid Management System. If any parts are missing or damaged, contact an authorized Smith & Nephew representative. Save the carton and packing materials in the event a component must be returned for repair. The following components should have been received: Carton 1

(REF 7210166)

1 ea.

Roller base

5 ea.

Canister holders

1 ea.

Carrier plate

1 ea.

Large washer (size M10)

1 ea.

Socket head screw (size M10)

2 ea.

Allen wrenches (small, large)* * attached under carrier plate

Carton 2

(REF 7210165)

1 ea. Preassembled stand system: a scale supporting the carrier plate and scale system support poles, fluid bag deflector, fluid bag holder, and fluid monitor unit. Carton 3

(REF 7210164)

1 ea.

Control unit

Carton 4

(REF 72200094)

1 ea.

Vacuum regulator

Carton 5

Accessory Kit (REF 7210473)

3 ea.

Power cords (US, UK, International)

1 ea.

Operations/Service Manual (REF 1061372)

Figure 1. Component identification

8

1

Fluid monitor display

9

Scale with canister holder brackets

2

Fluid bag holder

10

Canister holder brackets

3

Fluid bag deflector

11

Collection system canister (five total)

4

Control unit

12

Locking roller brakes

5

Carrier plate

13

Roller base

6

Vacuum regulator

14

Canister holder (five total)

7

Scale system support pole

15

Load controller bracket

8

Carrier plate support pole

1061372 Rev. H

Smith & Nephew Hysteroscopic Fluid Management System

Operations/Service Manual

System Components (continued)

Assemble the Components

Assemble the Roller Base to the Stand 1. Place the roller base 6 on a smooth level surface with the roller brakes facing you. 2. With the fluid monitor display facing you, place the stand assembly into the support hole in the roller base 5 . Position the stand so the canister holder brackets are centered between the legs of the roller base. 3. Center the large washer 7 underneath the base; insert the socket head screw 8 and lightly hand-tighten (Figure 3).

Figure 3. Washer orientation

Assemble the Carrier Plate to the Support Pole 1. Slide the carrier plate onto the short carrier plate support pole. The two set screws in the carrier plate should be positioned over the corresponding holes in the carrier plate support pole.

Figure 2. Assemble the roller base to the stand 1

Carrier plate

2

Carrier plate support pole

3

Base support pole

4

Base pole bushing

5

Roller base support hole

6

Roller base

7

Large washer

8

Socket head screw

Smith & Nephew Hysteroscopic Fluid Management System

WARNING: Ensure that the O-ring in the load controller bracket is properly seated and does not touch the scale system support pole. 2. Using the small Allen wrench, securely tighten the set screws.

Operations/Service Manual

Figure 4. Carrier plate

1061372 Rev. H

9

System Components (continued)

Assemble Remaining Components 1. Stand in front of the carrier plate. Grasp the carrier plate and tilt the stand forward. Gently lay the stand on an even floor surface. The carrier plate handle 2 should rest on the floor as shown in Figure 5.

6. Connect the data cable from underneath the carrier plate to the data cable receptacle on the rear of the pump control unit. 7. Connect the power cord to the power cord receptacle on the rear panel of the pump control unit. Note: The power cord should hang freely and be centered in the opening of the fluid bag deflector. 8. Thread an equipotential compensation cable from the bottom through the opening of the carrier plate. Connect the cable to the equipotential compensator terminal on the rear of the pump control unit. 9. Securely clip the equipotential compensation cable to the cable clip under the carrier plate. WARNING: Ensure neither the power cord nor the equipotential cable touch any part of the scale system, including fluid collection system canisters. This may lead to an error in monitoring the fluid deficit. The control unit may only be operated with angular equipotential MC plugs. The scale system includes the collection system canisters and holders, the scale, scale system support pole, fluid bag holders, and the fluid monitor unit. 10. Insert the canister holders into the brackets on the scale. Insert collection system canisters as required.

Figure 5. Orientation of the carrier plate to the roller base 1

Carrier plate

2

Carrier plate handle

3

Rollers

4

Allen wrench

11. Refer to the Preoperative Setup section of this manual for connecting canisters to each other and to the vacuum regulator.

WARNINGS • Ensure that all components are properly aligned.

2. Use the large Allen wrench 4 to securely tighten the socket head screw in the center of the base.

• Ensure that the two support poles are properly aligned with the load controller bracket and the bracket is tightened.

3. Raise the assembled stand and lock the roller brakes in place.

12. Connect the vacuum regulator to the carrier plate support pole.

4. Adjust the fluid monitor unit to a vertical position and ensure that the cables have not been damaged. If necessary, remove the plastic cap covering the locking screw on the fluid monitor unit mounting bracket. Use the large Allen wrench to tighten or loosen the locking screw as needed to allow for easy repositioning of the unit.

Note: The vacuum regulator clamp must not touch the scale support pole.

5. Center the irrigation pump control unit on the carrier plate so that the control unit rear panel touches the U-shaped stop bracket on the rear of the carrier plate (Figure 6).

Figure 6. Stop bracket

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1061372 Rev. H

Smith & Nephew Hysteroscopic Fluid Management System

Operations/Service Manual

System Components (continued)

Control Unit Front Panel

Figure 7. Smith & Nephew Hysteroscopic Fluid Management System control unit front panel

Control

Function

1

Start/Stop button

Calibrates/deactivates the unit.

2

Start/Stop LED

Illuminates when the Start/Stop button is pressed.

3

Overpressure indicator

Indicates intrauterine pressure of 200 mmHg has been reached.

4

IU PRESSURE display

Displays the intrauterine pressure.

5

MAX FLOW display

Indicates the maximum flow rate available.

6

Roller wheel

Bidirectional wheel to pressurize or depressurize the uterine cavity.

7

Pressure transducers

Senses the pressure generated by the irrigation pump.

8

MAX FLOW up/down buttons

Allows adjustment of the maximum flow rate.

9

Service indicator

Indicates that the system requires service.

10

Menu button

Allows entry to the user menu.

11

SET PRESSURE display

Displays the set pressure.

12

SET PRESSURE up/down buttons

Allows adjustment of the set pressure.

13

On/Off LED

Indicates on/off status of the unit.

14

On/Off button

Turns the power to the unit on/off.

15

Stand-By Mode LED

Indicates the unit is in Stand-By Mode (connected to a power source).

Smith & Nephew Hysteroscopic Fluid Management System

Operations/Service Manual

1061372 Rev. H

11

System Components (continued)

Control Unit Rear Panel

Figure 8. Control unit rear panel

Control

Function

1

Power cord receptacle

Connection for hospital-grade power cord.

2

Equipotential compensator terminal

Connection for equipotential cable.

3

Data cable receptacle

Connection for fluid monitor display data cable.

4

Service interface receptacle

Connection for service interface cable.

Fluid Monitor Display

Figure 9. Fluid monitor display front panel

Figure 10. Fluid monitor display rear panel

Control

Function

1

FLUID DEFICIT display

Displays the amount of irrigation fluid lost during the procedure.

2

TOTAL VOLUME display

Displays the total irrigation fluid volume used during the procedure.

3

Reset button

Resets the FLUID DEFICIT and TOTAL VOLUME displays.

4

Fluid deficit alarm indicator

Alerts the user of a potential problem in the uterine cavity.

5

Fluid deficit bar graph

Presents the deficit value as a percentage of the set deficit alarm value.

6 Mounting bracket with

locking screw

Attaches the fluid monitor display to the scale support pole. The locking screw under the plastic cap is used to adjust the position of the fluid monitor display.

7

Data cables

Integrated data cables connecting the fluid monitor display to the scale system.

12

1061372 Rev. H

Smith & Nephew Hysteroscopic Fluid Management System

Operations/Service Manual

Recommended System Configuration

Recommended System Configuration IEC 60601-1-1 Compliant System Configuration Figure 10 indicates a system configuration that complies with IEC 60601-1-1 requirements.

WARNINGS • If this unit is configured as part of a system, the entire system (TRUCLEAR™ System and Hysteroscopic Fluid Management System) should be tested for compliance with IEC 60601-1-1.

• If the leakage current of the configured system exceeds the limits of IEC 60601-1-1, install an appropriately rated UL 60601-1/IEC 60601-1 approved isolation transformer and retest the system. • The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include: – Use of the accessory in the patient vicinity. – Evidence that the safety certification of the accessory has been performed in accordance with UL 60601-1/IEC 60601-1.

Start

System fails to initialize – service indicator illuminated

Obtain RA for Service Exchange

Receive replacement control unit and monitor system

Replace control unit

Functionality restored ?

Yes

Return defective control unit and unopened monitor system

End

No Replace monitor system Figure 11. IEC 60601-1-1 Compliant System Configuration

Functionality restored ?

Yes

Replace original control unit

No Check all cabling – replace as necessary

Smith & Nephew Hysteroscopic Fluid Management System

Functionality restored ?

Yes

Return defective monitor system and replacement control unit

End

No

Operations/Service Manual

1061372 Rev. H

13

Preoperative Setup

Preoperative Setup

Hang the Fluid Bags

WARNINGS

WARNINGS

• The complete fluid monitor system is composed of a scale system and a carrier plate stand, each of which includes its own components. To ensure the accuracy of fluid measurement, these individual components must not touch one another. • Ensure neither the power cord nor the equipotential cable touch any part of the scale system, including fluid collection system canisters. This may lead to an error in monitoring the fluid deficit. The control unit may only be operated with angular equipotential MC plugs.

• The volume of the irrigation fluid entering and leaving the patient has to be strictly monitored. If a low viscosity liquid distension medium is used, intrauterine instillation exceeding 2 liters should be followed with great care due to the possibility of fluid overload. If a high viscosity fluid (e.g. Hyskon) is used, the use of more than 500 ml should be followed with great care. Refer to the labelling of the irrigation fluid used for additional information. • Only sterile saline can be used with the Smith & Nephew TRUCLEAR™ System.

• Work exclusively with sterile substances, sterile fluids, and sterile accessories.

• This system is intended only for use with plastic fluid canisters and fluid bags. Glass canisters or bottles may break, and there is a risk of implosion.

Power Supply Connection

• Use of bags or canisters not approved for this system, or large and/or lopsided loads, may cause the device to tip over.

WARNING: To avoid the risk of electrical shock, connect the power cord to a properly wired grounding receptacle only.

• Fluid bags must be hung to the rear of the fluid bag deflector to allow for accurate accountability of irrigation fluid usage.

CAUTION: Ensure that the available mains voltage matches the data listed on the label attached to the back of the control unit. Incorrect voltage can cause errors or malfunction, and may destroy the equipment.

Safety Plug The power cord must be equipped with a safety plug. Use only the supplied power cord for the connection between the power plug and the control unit power receptacle.

U.S. Operation Only use a certified (UL listed) removable power cord, type SJT, minimum 18 AWG, with three leads. Plugs must comply with NEMA 5-15 and/or IEC 320/CEE22. A potential equalization connection is only ensured if the control unit is connected via a properly installed hospital-grade receptacle.

• Ensure that fluid bags hang freely. They must not be supported from the bottom, or the fluid deficit will not be measured accurately. Fluid bags must only be hung on the bag holder hooks. Hang up to four 5-liter bags maximum.

Connect Tube Sets to Devices The following instructions detail how to connect the items included in the Hysteroscopic Fluid Management System. Refer to Figures 12, 13, and 14 for correct tubing routing and connection points. WARNING: Tube sets are provided STERILE and are for single use only. Do not reuse. Do not resterilize. Prior to use, inspect the product package for signs of damage or tampering. If damaged, do not use. Discard any opened and unused product.

Potential Equalization Integrate the control unit into the potential equalization that corresponds to the electrical system. WARNING: Ensure neither the power cord nor the equipotential cable touch any part of the scale system, including fluid collection system canisters. This may lead to an error in monitoring the fluid deficit. The control unit may only be operated with angular equipotential MC plugs.

14

1061372 Rev. H

Smith & Nephew Hysteroscopic Fluid Management System

Operations/Service Manual

Preoperative Setup (continued)

Tube Set Connections Using the TRUCLEAR™ System

Figure 12. TRUCLEAR System tubing and device connections

1

Saline bags

16

Drape outflow tubing (blue connector)

2

Insertion spikes

17

TRUCLEAR Hysteroscope gravity collection system canister

3

Inflow tube set

18

Drape vacuum collection system canisters (2)

9

Control unit head

19

Vacuum collection system canisters (2)

11

TRUCLEAR handpiece

20 Tissue trap

12

TRUCLEAR handpiece outflow tubing (white connector)

21

13

TRUCLEAR Hysteroscope with blade and sheath

22 Vacuum regulator

14

TRUCLEAR Hysteroscope outflow tubing (yellow connector)

23 Stopcock port

15

Patient drape

24 Connection to vacuum source

Connection tubing

WARNING: Only sterile saline can be used with the Smith & Nephew TRUCLEAR System.

Smith & Nephew Hysteroscopic Fluid Management System

Operations/Service Manual

1061372 Rev. H

15

Preoperative Setup (continued)

Tube Set Connections Using the TRUCLEAR™ Hysteroscopic Instrument Sets

Figure 13. Diagnostic hysteroscopy tubing and device connections

1

Fluid bags

16

Drape outflow tubing (blue connector)

2

Insertion spikes

17

TRUCLEAR Hysteroscope gravity collection system canister

3

Inflow tube set

18

Drape vacuum collection system canisters (2)

9

Control unit head

21

Connection tubing

13

TRUCLEAR Hysteroscope with sheath

22

Vacuum regulator

14

TRUCLEAR Hysteroscope outflow tubing (yellow connector)

23

Stopcock port

15

Patient drape

24

Connection to vacuum source

Note: Choose the appropriate irrigation fluid for the procedure being performed. Note: Similar tubing connections may be used when other diagnostic scopes are used.

16

1061372 Rev. H

Smith & Nephew Hysteroscopic Fluid Management System

Operations/Service Manual

Preoperative Setup (continued)

Tube Set Connections Using the Resectoscope/Hysteroscope

Figure 14. Resectoscopy tubing and device connections 1

Fluid bags

18

Drape vacuum collection system canisters (2)

2

Insertion spikes

19

Outflow vacuum collection system canisters (2)

3

Inflow tube set

20

Tissue trap

9

Control unit head

21

Connection tubing

13

Resectoscope

22

Vacuum regulator

14

Resectoscope outflow tubing (yellow connector)

23

Stopcock port

15

Patient drape

24

Connection to vacuum source

16

Drape outflow tubing (blue connector)

Note: Choose the appropriate irrigation fluid for the procedure being performed. Note: Similiar tubing connections may be used when other operative scopes are used.

Smith & Nephew Hysteroscopic Fluid Management System

Operations/Service Manual

1061372 Rev. H

17

Preoperative Setup (continued)

Connect the Inflow Tube Set

Insert the Roller Tubing Section

The Smith & Nephew inflow tube set consists of three tubing sections (irrigation, roller, and instrument); one pressure chamber; one locking ring; and two insertion spikes to connect the Irrigation section to the fluid bags.

When inserting the roller tubing section, do not damage the membranes of the pressure chamber. Insert the pressure chamber only if unpressurized.

Figure 16. Roller tubing insertion 3

Irrigation tubing section

4

Locking ring

5

Roller tubing section

6

Pressure chamber

Figure 15. Assembled inflow tube set

7

Pressure chamber key

1

Fluid bags

8

Instrument tubing section

2

Irrigation spikes

9

Pump head

3

Irrigation tubing section

10

Pressure chamber membranes

4

Locking ring

5

Roller tubing section

1. Remove the transportation safeguard from the pressure chamber.

6

Pressure chamber

7

Pressure chamber key

8

Instrument tubing section

9

Pump head

2. (A) Slide the pressure-free pressure chamber carefully (nose upward) into the slot in the pump head. Listen for a click when locking the pressure chamber into position. When properly inserted, the pressure chamber is flush with the pump head. Ensure the pressure transducer membranes are not damaged. 3. Place the roller tubing section around the roller wheel. 4. (B) Insert the locking ring by pulling on the tubing until the locking ring snaps into place.

18

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Smith & Nephew Hysteroscopic Fluid Management System

Operations/Service Manual

Preoperative Setup (continued)

Connect to the Fluid Bags Use aseptic technique. Grasp an insertion spike by the handle and connect the Irrigation tubing section to the fluid bags. Close tubing clamps. Note: When connecting or removing tubing to or from a fluid bag, always grasp the insertion spike by the handle.

Connect to the Hysteroscope/Resectoscope 1. Remove the cap from the Instrument tubing section. 2. Connect the blue luer connector on the Instrument tubing section to the hysteroscope inflow stopcock. Note: The inflow stopcock on the Smith & Nephew TRUCLEAR™ Operative Hysteroscope is identified with a blue ring.

Connect the Smith & Nephew Outflow Tube Set The outflow tube set consists of three tubing sections: one for patient drape, one for a Smith & Nephew TRUCLEAR Handpiece, and one for hysteroscope or resectoscope outflow.

3. Connect the other end of the handpiece tubing to the tissue trap in the first vacuum canister. 4. Using the connection tubing, connect the vacuum canisters in a series, beginning with the canister that has the tissue trap. Note: Refer to the canister manufacturer’s instructions for attaching canisters to each other and to suction equipment. The canister holders supplied with the Hysteroscopic Fluid Management System accept canisters manufactured by Bemis Manufacturing Company (REF 72200024/Bemis P/N 3025055). 5. Connect the last canister in the series to the vacuum regulator using the vacuum port on the canister lid. 6. Connect the vacuum regulator to a vacuum source such as wall suction or a stand-alone vacuum pump. 7. Ensure that the vacuum regulator is turned on. When connected to a vacuum source, the applied vacuum should be between 150–200 mmHg. In order to achieve vacuum, all canister lids, caps, and interconnecting tubes must be securely attached. Refer to the manufacturer’s instructions supplied with the vacuum regulator.

Connect the Outflow Tubing (Yellow Connector)

Connect the Drape Outflow Tubing (Blue Connector)

1. Connect the end fitted with the yellow luer lock onto the hysteroscope sheath outflow stopcock (identified with a yellow ring on hysteroscope).

1. Connect one end to the patient drape.

2. Connect the other end of the hysteroscope outflow tubing to the collection system canister designated for gravity.

2. Connect the other end to the first of the drape vacuum canisters using the patient port of the canister lid. 3. Using the connection tubing (Figure 12, 13, 14, 21 ), connect the drape vacuum canister in a series beginning with the canister connected to the patient drape. 4. Connect the last canister in the series to the stopcock port of the vacuum regulator (Figure 12, 13, 14, 23 ). 5. Open the stopcock to apply vacuum to the canister and patient drape.

Operative Hysteroscopy Procedure Using the Smith & Nephew TRUCLEAR System Refer to Figure 12 to:

1. Open the working channel stopcock on the hysteroscope completely. 2. Insert the Hysteroscopic Morcellator blade into the Smith & Nephew Operative Hysteroscope. Refer to the Instructions for Use for the Smith & Nephew Disposable Hysteroscopic Morcellator Blades (REF 1061210).

Refer to Figure 13 to:

• Connect the outflow tubing

Connect the Handpiece Tubing (White Connector) 1. Connect one end to the barbed fitting on the TRUCLEAR Handpiece. 2. Insert a tissue trap into the lid of the first of the collection system canisters designated as vacuum canisters.

Smith & Nephew Hysteroscopic Fluid Management System

Insert the Blade into the Hysteroscope

Diagnostic Hysteroscopy Procedure

• Connect the handpiece tubing

Note: Use only one tissue trap.

Assemble the Smith & Nephew Hysteroscopic Morcellator

Connect the Outflow Tubing (Yellow Connector) 1. Connect the end fitted with the yellow luer lock onto the sheath outflow stopcock. 2. Connect the other end of the outflow tubing to the collection system canister designated for gravity.

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Preoperative Setup (continued)/Operation

Technical Overview

Resectoscopy Procedure (Regulated Suction)

Set pressure can be set in a range from 15–120 mmHg. Nominal flow can be set to between 30–700 ml/min. The pump control unit should only be used with a hysteroscope indicated for hysteroscopic procedures.

Refer to Figure 14 to:

Connect the Resectoscope Outflow Tubing (Yellow Connector)

Refer to System Safety Features and Accessing the User Menu in this manual for complete information.

1. Connect the end fitted with the yellow luer lock onto the resectoscope sheath outflow stopcock (Figure 14, 13 ). 2. Connect the other end of the resectoscope outflow tubing to the first vacuum canister. 3. Using the connection tubing (Figure 14, 21 ), connect the resectoscope vacuum canisters in series as shown (Figure 14, 21 ). 4. Connect the last canister in the series to the hysteroscopic vacuum regulator using the vacuum port on the canister lid. 5. Connect the vacuum regulator to a vacuum source such as wall suction or a stand-alone vacuum pump. 6. Ensure that the vacuum regulator is turned on. In order to achieve vacuum, all canister lids, caps, and interconnecting tubes must be securely attached.

Verify Tubing Connections Once all tubing is connected, ascertain that all connections are securely attached; that there are no bends, kinks, or sharp turns in the tubing; and that the tubing has not been routed nor supported near sharp objects. WARNING: Ensure that the O-ring in the load controller bracket is properly seated and does not touch the scale system support pole. CAUTION: Do not step on, stand on, or roll objects over any tubing. Avoid high traffic areas where tubing may be subjected to detachment. Note: Ensure that the bags, tubes, collection system canisters, or other parts of the scale system do not come into contact with the irrigation pump control unit, the carrier plate, the carrier plate support pole, or the roller base.

Confirm Scope Connection 1. Verify that the scope inflow stopcock is completely open. 2. Refer to the manufacturer’s Instructions for Use for additional information. WARNING: The system must only be used with hysteroscopes and resectoscopes designed for the intended surgical procedure. The scopes must comply with the most recent versions of EN 60601-2-18.

Operation Plug into a Power Source Plug the pump control unit power cord into an appropriate power source. A potential equalization connection is only ensured if the control unit is connected via a properly installed hospital-grade receptacle. WARNING: If obvious defects are present, especially at the power cord receptacle or power cord, the control unit should not be used. Each time the power cord is plugged into a power source, the Stand-By Mode LED, On/Off LED, and Service Indicator are illuminated; the control unit initializes; and the control unit conducts a self-test. The Stand-By Mode LED remains illuminated as long as the control unit is connected to a power source.

Turn Pump Control Unit On Read all warnings and cautions, and to understand all system information including controls, functions, and safety features prior to turning on the control unit. If the control unit is already plugged in but has been turned off (only the Stand-By Mode LED is illuminated), press the On/Off button to turn the control unit on. The control unit and fluid monitor unit initialize and the system conducts a self-test. The service indicator on the control unit remains illuminated during this time. At the end of the brief self-test, the control unit beeps three times, then the fluid monitor unit beeps three times. Approximately five seconds later the following default values appear in the pump control unit displays: IU PRESSURE:

0 mmHg

SET PRESSURE:

60 mmHg

MAX FLOW:

700 ml/min

Note: Pressure and flow are reset to default values whenever the control unit is switched on. The displays on the fluid monitor unit should read: FLUID DEFICIT:

0 ml

TOTAL VOLUME:

0 ml

% (DEFICIT bar graph): Top bar is illuminated.

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1061372 Rev. H

Smith & Nephew Hysteroscopic Fluid Management System

Operations/Service Manual

Operation (continued)

Adjust Pump Pressure and Flow Rate Pump Pressure Use the Up/Down buttons under the SET PRESSURE display: Depress button briefly: adjusts set pressure in increments of 5 mmHg. Depress button and hold: adjusts set pressure in increments of 10 mmHg. While increasing the set pressure, the SET PRESSURE display flashes and an alarm sounds when the safety threshold of 100 mmHg is reached. After two seconds, pressure may be increased again to a maximum of 120 mmHg.

Flow Rate Use the Up/Down buttons under the MAX FLOW display: Depress button briefly: adjusts flow rate in increments of 10 ml/min. Depress button and hold: adjusts flow rate in increments of 20 ml/min.

Instrument Detection The pump control unit optimizes pressure measurement using the instrument detection function. The instrument detection function uses inflow characteristics to ensure that accurate intrauterine pressure is created and maintained. When using the Smith & Nephew TRUCLEAR™ System, the instrument detection process can be achieved by using either a Smith & Nephew disposable hysteroscopic blade or a Smith & Nephew hysteroscope insert.* WARNING: The instrument detection process must only be performed outside of the patient. The hysteroscope or resectoscope must be held at the same height as the height at which the procedure is to be performed. Note: If instrument detection is performed 12" (30 cm) below patient height, the actual intrauterine pressure will be less than the IU PRESSURE display by 22 mmHg.

Start Pump Operation Refer to the Preoperative Setup section of this manual for instructions on inserting and connecting all tubing, fluid bags, and devices. 1. Open the clamps on the irrigation inflow tubing.

4. The instrument detection process runs for approximately 30 seconds. A long beep signals the start of the instrument detection process. The irrigation pressure value is displayed in the IU PRESSURE display during this process.

• If detection is successful, the control unit emits another long beep, the Start/Stop LED glows continuously and fluid flows continuously. Fluid flow can be interrupted only by closing the hysteroscope inflow stopcock. If an attempt is made to stop the flow using the Stop/Start button, the instrument detection process must be repeated. • In case of error or malfunction the IU PRESSURE display depicts IE. The control unit emits five short warning beeps and then switches to the stop mode. • When repeating the instrument detection process, ensure both the working channel and inflow stopcocks are completely open, and that the instrument assembly is held at the proper height. • If pump is being restarted after a previous successful instrument detection, refer to the Restart Pump Operation section of this manual to eliminate tube priming step. 5. The IU PRESSURE display shows the current measured value. Note: If the pressure chamber is not fully inserted and the Start/Stop button is pressed, the control unit emits three short warning beeps; the roller wheel does not turn; and the Start/Stop LED does not illuminate. Refer to Insert the Roller Tubing in the Preoperative Setup section of this manual.

Stop Pump Operation Press the Start/Stop button again. The irrigation process is stopped. The current measured value continues to be displayed in the IU PRESSURE display.

Restart Pump Operation If pump has been operating and tube set is purged of air, it is possible to restart the pump without the pump air purging cycle. 1. Press and hold the Start/Stop button for >2 seconds; a double “beep” should sound. 2. The Start/Stop LED illuminates and flashes. 3. After a short delay (~ 2 seconds), the instrument detection process is performed.

2. Hold the connected hysteroscope assembly at the height of the roller wheel on the fluid management system control unit. 3. Press the Start/Stop button to start the irrigation process: – The Start/Stop LED flashes; – The control unit beeps once.

*The Smith & Nephew hysteroscope insert is available in the U.S. only Smith & Nephew Hysteroscopic Fluid Management System

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