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Summary of Contents for Integra SELECTOR
- Page 1 SELECTOR INTEGRA ® Ultrasonic Surgical Aspirator OPERATOR'S MANUAL Part No. OM 1530000M1 Issue C168-5 For use with SELECTOR Consoles of Part Number 1530000 ® (Serial No: 96100 onwards)
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Page 2: Table Of Contents
Installation ..................5 Footswitch ................6 Service Module ..............7 35kHz Neurosurgery handpiece .......... 8 Wrench Set ................8 Tubing Kit ................9 INTEGRA SYSTEM DESCRIPTION ....... 11 SELECTOR ® SELECTOR INTEGRA Console ..........11 ® Console Front Panel ............11 Console Left Side Panel ............ - Page 3 Recommended Sterilisation Instructions ........ 35 Steam Sterilisation ............. 35 Disinfection ................ 36 General Maintenance ..............36 Preventative Maintenance..........36 TROUBLESHOOTING ................37 INTEGRA Troubleshooting Guide ....... 38 SELECTOR ® Aspiration problems ............38 Irrigation problems ............. 40 No Ultrasonic Power ............42 Service Arrangements...............
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Page 4: Introduction
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, ®... -
Page 5: Electrical Safety
® agents or other volatile solvents. Hazards Environmental SELECTOR INTEGRA may be used or stored for extended periods in the following ® conditions: Conditions An ambient temperature range of +10°C to +40°C A Relative Humidity range of 30% to 75%... -
Page 6: 1.2 Product Approvals
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 ®... - Page 7 SELECTOR INTEGRA Operator Manual ® Issue C168-5...
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Page 8: Installation
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. -
Page 9: Footswitch
® 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’... -
Page 10: Service Module
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. -
Page 11: 35Khz Neurosurgery Handpiece
® 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. -
Page 12: 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... - Page 13 SELECTOR INTEGRA Operator Manual ® Issue C168-5...
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Page 14: Selector ® Integra System Description
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:-... - Page 15 1 hour. Timer reset button Momentarily depressing this button resets the operating time display to zero (i.e. a blank display). SELECTOR INTEGRA Operator Manual ® Issue C168-5...
- Page 16 Instructions. Symbol This is an international symbol indicating the equipment has been specifically designed to meet type CF (Cardiac Floating) safety standards. Symbol This is a graphic symbol to represent the handpiece connection. SELECTOR INTEGRA Operator Manual ® Issue C168-5...
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Page 17: Console Left Side Panel
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. SELECTOR INTEGRA Operator Manual ® Issue C168-5... -
Page 18: Console Rear Panel
Console Rear Panel The components and connection points on the rear panel are illustrated and described below. SELECTOR ® INTEGRA ULTRASONIC SURGICAL ASPIRATOR 1530000 SPEMBLY MEDICAL LTD. Mains inlet An international standard inlet which accepts the power cord supplied with the instrument. - Page 19 INTEGRA Service Module. ® power outlet Cooling fan air outlet Air which is drawn through the SELECTOR INTEGRA Console to cool the internal ® electronic systems leaves the instrument through this grille which should be kept clear of any obstruction.
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Page 20: 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 ®... -
Page 21: Selector Integra Service Module
® Service Module The Service Module provides a convenient ‘small footprint’ mobile base for the SELECTOR INTEGRA Console, as well as a source of suction and waste ® collection. It is powered from the SELECTOR INTEGRA Console and has no ®... -
Page 22: Selector Integra Handpieces
® Handpieces General Description Each handpiece is made up of three or four sections: The black handle bearing the name SELECTOR contains the piezoelectric ® transducer which includes an array of piezo ceramic elements to convert the high frequency power signal from the SELECTOR INTEGRA Console into mechanical ®... -
Page 23: Standard Handpieces
Standard shroud 1523017 Thin walled tip 1523013 24kHz angled handpiece (Part Number 1523000M2) Part Number Transducer assembly Angled extension 1523033 Thin walled tip 1523015 Angled shroud 1523049 Extension shroud 1523035 Flue disposable 1523042 SELECTOR INTEGRA Operator Manual ® Issue C168-5... - Page 24 Flue disposable 1523043 Standard shroud 1523018 Thin walled tip 1523014 24kHz laparoscopic handpiece (Part Number 1523000M6) Part Number Transducer assembly Flue reusable 1523032 Shroud extension 1523031 1523029 Shroud 1523030 Step Amplifier 1523028 Tubing clamp SELECTOR INTEGRA Operator Manual ® Issue C168-5...
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Page 25: 24Khz Laparoscopic Handpieces
24kHz Laparoscopic The Laparoscopic handpiece is a variant of the standard straight 24kHz SELECTOR ® Handpieces handpiece in which the front of the handpiece is extended to facilitate its use in laparoscopic surgery. The Laparoscopic handpiece has an external diameter along its working length of 10mm and has been used with both reusable and disposable 10/10.5mm trocar... - Page 26 Extension shroud 1523045 Flue disposable 1523047 35kHz Neurosurgery handpiece (Part Number 1523000M8) Part Number Transducer assembly 35 kHz Ultra-Fine tip 1523082 Angled extension 1523058 Handle extension shroud 1523060 Extension shroud 1523062 Flue 1523063 SELECTOR INTEGRA Operator Manual ® Issue C168-5...
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Page 27: Microsurgical Handpiece
MicroSurgical 24kHz MicroSurgical handpiece (Part Number 1529000) Handpiece Part Number Transducer assembly Ultra-Fine tip 1529012 Angled extension 1529043 Flue/extension 1529014 Extension shroud 1529024 SELECTOR INTEGRA Operator Manual ® Issue C168-5... -
Page 28: Operating Instructions
OPERATING INSTRUCTIONS This Section describes the procedure to be followed to prepare the SELECTOR ® INTEGRA for operation. It is important that readers of this Section are familiar with the theory and description of the system as covered in the earlier Sections of this manual and with the safety and operational precautions detailed in Appendix 3. - Page 29 fluid is expected to be collected. If an external suction source is used instead of the SELECTOR ® INTEGRA Service Module ensure that this operates at a constant vacuum pressure between 73kPa and 90kPa (560mmHg and 680mmHg), and that a suitable waste collection system is set-up (see Section 2.2, Service Module, for further detail).
- Page 30 MicroSurgical tubing kit to the rear of the handpiece. The smaller lumen fits onto the small irrigation port while the larger fits onto the aspiration port. Connect the other end of the MicroSurgical tubing to the standard SELECTOR Tubing Kit ®...
- Page 31 (If the SELECTOR INTEGRA Service Module is not used, connect this ® tube to the waste collection vessel of the suction system used.)
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Page 32: Pre-Operative Checks
PRE-OPERATIVE CHECKS Prior to using the SELECTOR INTEGRA it is essential that the correct set-up and ® function of the system is validated by performing the following checks. Switch on the power to the system by pressing the mains power switch located on the rear panel of the Console below the power cord inlet. - Page 33 Should a fault occur full details of the error detection systems on the SELECTOR INTEGRA are given in Section 3 and troubleshooting is ® described in Section 7. At intervals during operative use, it is recommended that the tip of the handpiece be immersed momentarily in sterile water or saline.
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Page 34: Post Operative Breakdown And Cleaning
Do not remove the filter situated behind the waste collection canisters at the front of the Service Module. Record the time displayed on the front panel as a means of monitoring tip usage and turn off the power on the rear panel of the SELECTOR INTEGRA ®... -
Page 35: Handpiece Cleaning
5.3 Handpiece The SELECTOR handpiece must be disassembled and cleaned prior to sterilisation ® Cleaning using the following procedure: Prepare cleaning solution: hot water containing detergent in a sink or bowl is necessary to clean handpiece parts. Consult hospital policy for approved cleaning materials. -
Page 36: Assembly Of Handpieces
Clean and rinse the wrench set and add to the sterilisation tray. Sterilise according to hospital policy (see Section 6.1). 5.4 Assembly of Handpieces The SELECTOR handpiece should be re-assembled in the sterile field. ® Lay the handpiece in a wrench holder as shown in Figure 5 with the spanner flat 1 in the holder cut out. -
Page 37: Which Wrench Set For Which Handpiece
Attach the fresh flue assembly by clicking firmly into place. The handpiece is now ready for use. 5.5 Which Wrench SELECTOR INTEGRA Wrench Set Part Numbers: - ® 1523072M1 for handpieces 1523000M1, M2, M3 & M4 Set for Which... -
Page 38: Maintenance
MAINTENANCE 6.1 Recommended Before use, the Selector Handpiece and accessories must be cleaned as detailed in Sterilisation Section 5.3. Handpieces may be sterilised by Steam Sterilisation. As sterilisation systems in use at hospitals are chamber-specific, Integra can only recommend Instructions a reference to hospitals to aid the sterilisation parameters set for your hospital system. -
Page 39: Disinfection
Disinfection If disinfection is considered adequate by the hospital authorities, the SELECTOR ® handpiece may be disinfected in one of the following solutions: Glutaraldehyde based solutions such as Cidex or peracetic acid based solutions such as Nu-Cidex . Follow the instructions supplied by the manufacturer. -
Page 40: Troubleshooting
Operator’s Manual has been followed. To simplify this process the following flow charts guide the user towards a solution. If difficulties cannot be resolved the advice of qualified SELECTOR INTEGRA ® Service personnel should be sought. -
Page 41: Selector® Integra Troubleshooting Guide
7.1 SELECTOR® INTEGRA Troubleshooting Guide Aspiration problems SELECTOR INTEGRA Operator Manual ® Issue C168-5... - Page 42 Aspiration problems (continued) SELECTOR INTEGRA Operator Manual ® Issue C168-5...
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Page 43: Irrigation Problems
Irrigation problems SELECTOR INTEGRA Operator Manual ® Issue C168-5... - Page 44 Irrigation problems (continued) SELECTOR INTEGRA Operator Manual ® Issue C168-5...
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Page 45: No Ultrasonic Power
No Ultrasonic Power SELECTOR INTEGRA Operator Manual ® Issue C168-5... -
Page 46: Service Arrangements
Your supplier will advise you during installation of local arrangements for providing technical support and service. Should you encounter any difficulties in obtaining local service please contact the manufacturer of the SELECTOR INTEGRA. ® Customer Service Department... - Page 47 SELECTOR INTEGRA Operator Manual ® Issue C168-5...
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Page 48: Appendices
APPENDICES Appendix 1 Mechanism of Action The SELECTOR INTEGRA Ultrasonic Surgical Aspirator is intended for use in ® the selective removal of unwanted soft tissue during surgery, and has been used in neurosurgery and gastroenterology (including laparoscopic procedures) but not for liposuction procedures. -
Page 49: Classification Symbols, Warnings & Hazards
This is a graphic symbol for aspiration. This is a graphic symbol for irrigation. This is a graphic symbol for ultrasonic power. The SELECTOR INTEGRA System is Class 1 type CF Patient connected ® electrically isolated equipment (reference EN 60601). DANGER: Risk of explosion. - Page 50 Do not attempt to dismantle the rear handle sections of the handpieces: it contains no user serviceable parts. Note: Do not power up the SELECTOR handpiece without fully priming the ®...
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Page 51: Specification
Weight 39 Kg Vacuum -600 mm Hg (-80 kPa or 24” Hg) Vacuum Capacity 25 L/min free air Selector Integra System, Storage Requirements Ambient temperature +10 °C to +40 °C Humidity 30% to 75% Atmospheric Pressure 700 kPa to 1100 kPa... - Page 52 Manufactured by: Spembly Medical Limited Newbury Road Andover © Spembly Medical Limited 2002 Hampshire SP10 4DR Part number OM1530000M1 United Kingdom Issue C168-5 Tel: +44 (0)1264 345700 Fax: +44 (0)1264 332113...
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