SELECTOR Operators Manual Issue C168-5

Contents

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INTRODUCTION ... 1 1.1

Summary of Operating Safety Precautions ... 1 Handling of the Handpiece... 1 Backup Handpiece ... 1 Electrical Safety ... 2 Explosion and Fire Hazards ... 2 Environmental Conditions ... 2

1.2

Product Approvals ... 3

INSTALLATION... 5 2.1

Unpacking ... 5

2.2

Installation ... 5 Footswitch ... 6 Service Module ... 7 35kHz Neurosurgery handpiece ... 8 Wrench Set ... 8 Tubing Kit ... 9

SELECTOR® INTEGRA SYSTEM DESCRIPTION ... 11 3.1

SELECTOR® INTEGRA Console ... 11 Console Front Panel ... 11 Console Left Side Panel ... 14 Console Rear Panel ... 15 Footswitch ... 17

3.2

SELECTOR® INTEGRA Service Module ... 18

3.3

SELECTOR® INTEGRA Handpieces ... 19 General Description ... 19 Standard Handpieces ... 20 24kHz Laparoscopic Handpieces ... 22 Neurosurgery Handpieces ... 22 MicroSurgical Handpiece ... 24

OPERATING INSTRUCTIONS ... 25 4.1

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Pre-operative Set-up ... 25

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PRE-OPERATIVE CHECKS ... 29 5.1

Operative Use ... 29

5.2

Post Operative Breakdown and Cleaning ... 31

5.3

Handpiece Cleaning ... 32

5.4

Assembly of Handpieces ... 33

5.5

Which Wrench Set for Which Handpiece ? ... 34

MAINTENANCE ... 35 6.1

Recommended Sterilisation Instructions ... 35 Steam Sterilisation ... 35 Disinfection ... 36

6.2

General Maintenance ... 36 Preventative Maintenance... 36

TROUBLESHOOTING ... 37 7.1

SELECTOR® INTEGRA Troubleshooting Guide ... 38 Aspiration problems ... 38 Irrigation problems ... 40 No Ultrasonic Power ... 42

7.2

Service Arrangements ... 43

APPENDICES ... 45 Appendix 1 ... 45 Mechanism of Action... 45 Appendix 2 ... 45 Selecting the Correct Handpiece ... 45 Appendix 3 ... 46 Classification Symbols, Warnings & Hazards ... 46 Appendix 4 ... 48 Specification... 48

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INTRODUCTION

The SELECTOR® INTEGRA Ultrasonic Surgical Aspirator facilitates the removal of cellular and other unwanted soft tissue. The system provides selective tissue disintegration with simultaneous irrigation and aspiration. This Operator’s Manual should be read in its entirety by surgeons, nurses and technicians who will use, operate and maintain the SELECTOR® INTEGRA system, before using the instrument in a surgical procedure. Particular attention should be given to the operating safety precautions in Appendix 3. A separate SELECTOR® INTEGRA Service Manual (part number: SM1530000M1) is available for qualified electronic technicians trained in SELECTOR® INTEGRA maintenance. This covers the construction and service of the system. If, after reading this manual, you have any questions requiring further information, please contact Customer Service Department, Spembly Medical Limited, Newbury Road, Andover, Hampshire, SP10 4DR, United Kingdom (telephone: +44 (0)1264 345700) or your local supplier.

1.1 Summary of The SELECTOR® INTEGRA Ultrasonic Surgical Aspirator has been designed for Operating Safety use by surgeons in the areas of neurosurgery and gastroenterology (including laparoscopic procedures). Its use in other procedures is regarded as experimental Precautions and is thus subject to appropriate local regulatory approval. While the Operator’s Manual provides information on the operation of the system it provides no instructions for any specific surgical procedure.

It is imperative that the procedures described in this Operator’s Manual are followed carefully. The use of the instrument in any other manner may result in personal injury.

Handling of the Handpiece

Backup Handpiece

When the ‘POWER’ pedal is depressed to operate the handpiece, do not allow the tip of the handpiece to come into contact with any object except for the target tissue at the operating site. Touching the tip while powered can result in personal injury. Contact of the moving tip with a hard surface e.g. a metal instrument tray may damage the tip of the handpiece and may necessitate replacement before use. The SELECTOR® handpiece may be sterilised by steam autoclave or cold sterilisation solutions. (See Section 6.1 for further information). We recommend that a sterile backup handpiece be available for immediate use in the event of any contamination or malfunction during surgery. It is recommended that the appropriate wrench set is sterilised with the handpiece in order that it may be used to replace a tip if necessary.

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SELECTOR® INTEGRA Operator Manual Issue C168-5

Electrical Safety

The SELECTOR® INTEGRA system requires a single grounded electrical outlet providing power at 100, 120, 220, 230 or 240 volts, 50 or 60Hz (for set voltage see rear panel above mains power inlet). The maximum current drawn is 2.5 amps at 240 volts and 5 amps at 100 volts (with a Service Module connected). Power connection is made using the removable power cord provided. Correct grounding of the SELECTOR® INTEGRA Console is essential for safe operation. The Console is grounded via the power cord and it is important that this is connected to a properly grounded power receptacle of appropriate rating. Use only the power cord supplied with the unit since these vary according to destination. An external ground pin is also located on the rear panel (see page 16). The correct power cords are as follows: Mains Supply

Power Cord Part Number

Destination

100/120 volts

5557538 (fitted with type SJ cord and two blades plus grounding pin attachment plug designated ‘Hospital Grade’) 5557537 5557540 5557539 5557542

USA/Canada

100/120 volts 230 volts 240 volts 220/250 volts

Japan Europe U.K. Australia

Replace fuses only with those of the same type and rating; for details see the rear panel. Do not remove the instrument cover. The SELECTOR® INTEGRA Console contains no user serviceable parts and the system must be serviced only by qualified engineers trained in SELECTOR® INTEGRA maintenance. Interference with the Console by any other personnel may invalidate any warranty and may result in injury.

Explosion and Fire Do not operate the SELECTOR® INTEGRA in the presence of flammable anaesthetic agents or other volatile solvents. Hazards Environmental Conditions

SELECTOR® INTEGRA may be used or stored for extended periods in the following conditions: 1

An ambient temperature range of +10°C to +40°C

2

A Relative Humidity range of 30% to 75%

3

An atmospheric pressure range of 700hPa to 1100hPa

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1.2 Product Approvals

The SELECTOR® INTEGRA is manufactured by Spembly Medical Limited who operate a quality system which complies with the requirements of BS EN ISO 9001:1994 and BS EN 46001:1994. The SELECTOR® INTEGRA has been designed, constructed and approved to the requirements of the following international bodies: International Electrotechnical Commission (IEC) Underwriters Laboratories (UL) The SELECTOR® INTEGRA has been independently tested to the following standards: CSA 22.2 No. 601-1 EN 60601-1 EN 60601-1-2 FCC 15 & 18 JIS T1001 UL 2601-1 Note that the footswitch is additionally rated IPX 2.7 for dust and moisture resistance.

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INSTALLATION

2.1 Unpacking

Check the shipment for any signs of damage or loss. In the event of loss or damage please notify the carrier and the supplier immediately and retain all shipping cartons for examination.

2.2 Installation

The SELECTOR® INTEGRA Ultrasonic Surgical Aspirator will normally be installed by the manufacturer or supplier. Users are recommended to contact the supplier to obtain assistance and advice on the appropriate procedure. Following installation, the supplier will provide suitable training on the preparation, operation and care of the system. This will normally take the form of an in-service training course to appropriate doctors, nurses and operating department staff.

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SELECTOR® INTEGRA Operator Manual Issue C168-5

The SELECTOR® INTEGRA system consists of: SELECTOR® INTEGRA Console (Part Number 1530000), footswitch (Part Number 1520000) and power cable (Dimensions of Console: 39cm W, 49cm L,15cm H)

The SELECTOR® INTEGRA Console provides control and display of aspiration, irrigation and ultrasonic power for a SELECTOR® ultrasonic handpiece. The Console is used in conjunction with SELECTOR® ultrasonic handpieces, and with or without a SELECTOR® INTEGRA Service Module. A power cable and spare set of fuses is supplied with the SELECTOR® INTEGRA Console.

Footswitch

The footswitch has two pedals labelled ‘POWER’ (left hand) and ‘IRRIGATE’ (right hand, raised) together with a 3m cord plus plug which inserts into the socket labelled ‘FOOTSWITCH’ on the left side panel of the Console.

The footswitch is internally sealed and may be cleaned by immersion (see Section 6).

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Service Module

SELECTOR® INTEGRA Service Module (Part Number: 1531000) (Dimensions: 40cm W, 53cm L, 84cm H)

The SELECTOR® INTEGRA Service Module may be used to provide a convenient source of suction and aseptic waste collection. No further utilities are thus required. The SELECTOR® INTEGRA Service Module is connected to a line output socket at the rear of the SELECTOR® INTEGRA Console using a flying lead to be found in the Service Module. A spare set of SELECTOR® INTEGRA filters is supplied with the Service Module. If the SELECTOR® INTEGRA Console is used without the SELECTOR® INTEGRA Service Module then the instrument requires a suitable source of suction and a means of waste collection. Wall or ceiling mounted vacuum points in the operating room or a free-standing surgical suction unit should provide a suitable source of suction, provided that this operates at a constant vacuum pressure between 73kPa and 90kPa (560mmHg and 680mmHg) and has a free air flow capacity of more than 25 litres/min. A receptacle for the collection of waste is required between the SELECTOR® INTEGRA Console and the vacuum source. Where this is not provided by the SELECTOR® INTEGRA Service Module, the use of a disposable lined canister system such as the Abbott RECEPTAL™ system is recommended. However, a self-contained surgical suction system from a number of suppliers may provide suitable suction and waste collection. 7

SELECTOR® INTEGRA Operator Manual Issue C168-5

Handpiece

SELECTOR® Handpiece (Various Part Numbers – see section 3.4) (example shown: 35kHz Neurosurgery handpiece)

A brush for cleaning the aspiration channel of the handpiece is supplied with each handpiece. (Part Number: 1523101)

Wrench Set

SELECTOR® Wrench Set (Part Numbers: 1523072M1 1523072M2 1523072M3 1529056

for handpieces 1523000M1, M2, M3 & M4 for laparoscopic handpiece 1523000M6 for handpieces 1523000M5 , M7, M9, for MicroSurgical handpieces 1529000)

The Wrench Set is for assembly and disassembly of the handpiece for cleaning and sterilisation. An appropriate wrench set is supplied with each handpiece.

The SELECTOR® Wrench Set consists of a stainless steel holder and spanner, connected by a chain. The cut-outs in the holder are sized according to its use with specific handpieces. Use ONLY the SELECTOR® Wrench Set to tighten tips and extensions on the handpiece. Always secure the handle of the handpiece in the holder provided. Never assemble or disassemble the handpiece by holding the handle in your hand as damage may occur to the handpiece.

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Tubing Kit

SELECTOR® Tubing Kit (Part Number: 1517079, Box of 10) It is necessary to order a supply of sterile tubing kits for use with your SELECTOR® INTEGRA system. In addition, for use of the MicroSurgical handpiece you will need the MicroSurgical Tubing Kit (Part Number: 1529036, Box of 10)

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SELECTOR® INTEGRA SYSTEM DESCRIPTION

This Section describes the displays, connection points and operating controls of each part of the system.

3.1 SELECTOR® INTEGRA Console Console Front Panel The controls and displays of the front panel are illustrated and described below:-

1

Membrane control / display panel

A wipe clean panel providing operating controls and displays for each of the operating variables ‘ASPIRATION’, ‘IRRIGATION’ and ultrasonic ‘POWER’, together with the error check display warnings and an operation timer with reset button.

2

Aspiration display

Three digit LED display showing aspiration level variable between 1% and 100%. The display indicates the aspiration setting in units which approximate to “% of total available suction” at the source of vacuum employed. At settings below about 10% the suction is reproducible but the display becomes less accurate since at a display of 1% or below a residual suction pressure remains. Note that the zero setting is indicated by a blank display. In use, settings of between 30% and 90% are typical depending upon the preference of the surgeon.

3

Aspiration increase button

Momentarily depressing this touch button increases the aspiration level and display by one digit. Constant depression will cause the aspiration display to increase continually until the finger pressure is removed or until the maximum setting of 100% is reached.

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Aspiration decrease Momentarily depressing this touch button decreases the aspiration level and display by one digit. Constant depression will cause the aspiration display to decrease button continuously until the finger pressure is removed or until the minimum setting (a blank display) is obtained.

5

Irrigation display

A two digit LED display showing irrigation rate variable between 1 and 50ml/min. Note that a zero setting is indicated by a blank display. In use, settings of between 2 and 6ml/min are typical, depending upon the preference of the surgeon. Note that the irrigation rate set will be obtained only when the ‘POWER’ pedal is depressed on the footswitch. The setting on this display is ignored by the ‘IRRIGATE’ pedal which provides irrigation at between 0 and 50ml/min depending upon the ‘IRRIGATE’ pedal position.

6

Irrigation increase button

Momentarily depressing this touch button increases the irrigation display by 1 digit. Constant depression will cause the irrigation to increase continuously until the finger pressure is removed or until the maximum setting of 50ml/min is reached.

7

Irrigation decrease Momentarily depressing this touch button decreases the irrigation display by 1 digit. Constant depression will cause the irrigation display to decrease continuously button until the finger pressure is removed or until the minimum setting (a blank display) is obtained.

8

Ultrasonic power display

A three digit LED display showing ultrasonic power variable between 1 and 100%. As the power setting is increased to maximum, so the amplitude of the vibration of the tip of the handpiece increases to maximum and the tissue destruction increases. In use settings of between 50% and 100% are typical, depending upon the nature of the tissue and the preference of the surgeon. Note too that the ultrasonic power set is a maximum which will be obtained at the handpiece only when the ‘POWER’ pedal on the footswitch is fully depressed. Partial depression of the footswitch will give an actual power output below the maximum setting with the exact value depending on the pedal position.

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Power increase button

10

Power decrease button

Momentarily depressing this touch button increases the ultrasonic power display by 1 digit. Constant depression will cause the power display to increase continuously until the finger pressure is removed or until the maximum setting of 100 % is reached.

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Operating time display

12

Timer reset button

Momentarily depressing this touch button decreases the ultrasonic power display by 1 digit. Constant depression will cause the ultrasonic power display to decrease continuously until the finger pressure is removed or until the minimum setting (a blank display) is obtained. A four digit LED display which records the total duration of ultrasonic power application during surgery in minutes and seconds. It advances whenever the ‘POWER’ pedal on the footswitch is depressed and the system operates. It is reset to zero (a blank display) either automatically on power up, or by momentarily depressing the reset button adjacent to the display, or on reaching a duration of 1 hour. Momentarily depressing this button resets the operating time display to zero (i.e. a blank display).

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Handpiece error warning

The handpiece section of the graphic display flashes red to signify the presence of a handpiece error as defined more fully in Section 7 of this manual i.e. either a) b)

no handpiece connected two handpieces connected

This error warning light also flashes when the instrument is first powered on to check the display, but will extinguish when the system is operating satisfactorily (i.e. when the ‘POWER’ pedal on the footswitch is depressed with one properly working handpiece connected).

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Tip error warning

The tip section of the graphic display flashes red to signify the presence of a tip error as defined more fully in Section 7 of this manual.

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24kHz handpiece connection socket

Colour coded red and keyed to accept only the red plug attached to a 24kHz SELECTOR® ultrasonic surgery handpiece. This socket features a small red dot which should be aligned with the similar red dot on the plug of the handpiece cord before pushing the plug into the socket.

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35kHz handpiece connection socket

Colour coded green and keyed to accept only the green plug attached to a 35kHz SELECTOR® ultrasonic surgery handpiece. This socket features a small red dot which should be aligned with the similar red dot on the plug of the handpiece cord before pushing the plug into the socket.

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MicroSurgical handpiece socket

Colour coded black and keyed to accept only the black plug attached to a 24kHz SELECTOR® MicroSurgical handpiece. This socket features a small red dot which should be aligned with the similar red dot on the plug of the handpiece cord before pushing the plug into the socket.

18

Symbol

This is an international symbol referring the user to the instruction manual for detailed Instructions.

19

Symbol

This is an international symbol indicating the equipment has been specifically designed to meet type CF (Cardiac Floating) safety standards.

20

Symbol

This is a graphic symbol to represent the handpiece connection.

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SELECTOR® INTEGRA Operator Manual Issue C168-5

Console Left Side Panel

The components and connection points on the left side panel are illustrated and described below.

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Irrigation pump

A peristaltic pump which clamps into place across the irrigation tube of the disposable tubing set to pump irrigant from the I.V. fluid container to the handpiece. The direction of tubing connections to the pump are illustrated on the side panel label.

2

Aspiration Filter connection port

A port into which the aspiration filter is fitted to the disposable tubing. Push firmly to connect the aspiration tube to the aspiration control system.

3

Pinch valve

A normally open valve through which the aspiration tube is routed before connection to the suction system. This valve closes momentarily when the ‘POWER’ pedal on the footswitch is released to shut off the suction and facilitate the release of tissue from the tip of the handpiece. In addition, the valve closes when the ‘IRRIGATE’ pedal is depressed, thus stopping aspiration. The valve reopens when the ‘IRRIGATE’ pedal is released.

4

Footswitch socket

A keyed socket which will accept the plug attached to the footswitch cord. This socket features a small red dot which should be aligned with the similar red dot on the plug of the footswitch cord before pushing the plug into the socket.

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Console Rear Panel

1

The components and connection points on the rear panel are illustrated and described below.

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SELECTOR® INTEGRA ULTRASONIC SURGICAL ASPIRATOR 1530000

SPEMBLY MEDICAL LTD.

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1

Mains inlet

An international standard inlet which accepts the power cord supplied with the instrument.

2

Power switch

A rocker switch which is switched from the off (marked ‘0’) position to the on (marked ‘I’) position to power the instrument.

3

Fuseholder

A holder for two mains fuses. A rear panel label below the fuseholder gives information on the rating of fuses fitted to the instrument. It is important for safe operation of the instrument that fuses are replaced by those of the same type and rating.

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Service Module power outlet

5

Cooling fan air outlet Air which is drawn through the SELECTOR® INTEGRA Console to cool the internal

6

Ground point

This external ground pin is connected to the main internal instrument grounding point and is used in some countries as the point to which a separate grounding lead is attached.

7

Vacuum pressure gauge

This gauge indicates the negative pressure within the suction system of the instrument and is used in troubleshooting any problems which occur in the aspiration system (see Section 7).

8

Irrigation pole

This folding telescopic pole provides a convenient stand for a bag or bottle of irrigation fluid. The extending section of the pole can be set at the desired height and locked by turning clockwise the locking collar at the top of the fixed section. When not required the extending section of the pole can be pushed down (after turning the locking nut at the top of the fixed section counter clockwise) and the pole folded to a horizontal position. The irrigation pole is designed to support a 500ml or 1000ml irrigation bag. If a larger bag or a glass bottle is used it should be placed on a separate irrigation stand.

A socket providing output power which accepts the power lead from the accessory SELECTOR® INTEGRA Service Module. electronic systems leaves the instrument through this grille which should be kept clear of any obstruction.

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Footswitch

The footswitch has two pedals labelled ‘POWER’ (left hand) and ‘IRRIGATE’ (right hand) together with a 3m cord plus plug which inserts into the socket labelled ‘FOOTSWITCH’ on the left side panel of the Console.

Once connected to a powered SELECTOR® INTEGRA Console, depression of the pedals has the following effect: ‘POWER’ pedal: when depressed this:

•

Switches on irrigation at the preset rate indicated on the front panel irrigation display.

•

Switches on ultrasonic power to a level which varies in an approximately linear fashion from zero (when the pedal is not depressed), to the maximum value indicated on the front panel power display (when the pedal is fully depressed).

Note: When the ‘POWER’ pedal is released after depression, the pinch valve operates momentarily to block aspiration and facilitate tissue release from the handpiece tip. ‘IRRIGATE’ pedal : when depressed switches on irrigation only at a rate which varies in an approximately linear fashion from zero (when the pedal is not depressed) to 50ml/min (when the pedal is fully depressed). Note that the irrigation setting on the front panel display has no influence upon the irrigation rate when the ‘IRRIGATE’ only pedal is depressed. When the ‘IRRIGATE’ pedal is depressed, aspiration is stopped until the pedal is released. The footswitch is internally sealed and may be cleaned by immersion (see Section 6).

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