Integra SELECTOR User manual

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)

SELECTOR® INTEGRA Operator Manual
Issue C168-5
Contents
1 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
2 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
3 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
4 OPERATING INSTRUCTIONS .............................................................. 25
4.1 Pre-operative Set-up ..................................................................25
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SELECTOR® INTEGRA Operator Manual
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5 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
6 MAINTENANCE ..................................................................................... 35
6.1 Recommended Sterilisation Instructions ................................ 35
Steam Sterilisation .............................................................35
Disinfection ........................................................................36
6.2 General Maintenance .................................................................36
Preventative Maintenance .................................................. 36
7 TROUBLESHOOTING ........................................................................... 37
7.1 SELECTOR® INTEGRA Troubleshooting Guide .......................38
Aspiration problems ........................................................... 38
Irrigation problems ............................................................. 40
No Ultrasonic Power .......................................................... 42
7.2 Service Arrangements ...............................................................43
8 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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SELECTOR® INTEGRA Operator Manual
Issue C168-5
1 INTRODUCTION
1.1 Summary of
Operating Safety
Precautions
Handling of the
Handpiece
Backup Handpiece
1
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: [phone]
345700) or your local supplier.
The SELECTOR® INTEGRA Ultrasonic Surgical Aspirator has been designed for
use by surgeons in the areas of neurosurgery and gastroenterology (including
laparoscopic procedures). Its use in other procedures is regarded as experimental
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.
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.

SELECTOR® INTEGRA Operator Manual
Issue C168-5
Electrical Safety
Explosion and Fire
Hazards
Environmental
Conditions
2
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 USA/Canada
(fitted with type SJ cord and two
blades plus grounding pin
attachment plug designated
‘Hospital Grade’)
100/120 volts 5557537 Japan
230 volts 5557540 Europe
240 volts 5557539 U.K.
220/250 volts 5557542 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.
Do not operate the SELECTOR® INTEGRA in the presence of flammable anaesthetic
agents or other volatile solvents.
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

SELECTOR® INTEGRA Operator Manual
Issue C168-5
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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SELECTOR® INTEGRA Operator Manual
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SELECTOR® INTEGRA Operator Manual
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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.
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.
2 INSTALLATION
2.1 Unpacking
2.2 Installation
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SELECTOR® INTEGRA Operator Manual
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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.
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).
Footswitch
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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.
Service Module
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SELECTOR® INTEGRA Operator Manual
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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)
SELECTOR® Wrench Set (Part Numbers:
1523072M1 for handpieces 1523000M1, M2, M3 & M4
1523072M2 for laparoscopic handpiece 1523000M6
1523072M3 for handpieces 1523000M5 , M7, M9,
1529056 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.
Handpiece
Wrench Set
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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)
Tubing Kit
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This Section describes the displays, connection points and operating controls of
each part of the system.
The controls and displays of the front panel are illustrated and described below:-
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.
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.
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.
3 SELECTOR® INTEGRA SYSTEM DESCRIPTION
3.1 SELECTOR® INTEGRA
Console
2 Aspiration display
1 Membrane control /
display panel
3 Aspiration increase
button
Console Front Panel
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5 Irrigation display
9 Power increase
button
4 Aspiration decrease
button
10 Power decrease
button
8 Ultrasonic power
display
7 Irrigation decrease
button
6 Irrigation increase
button
11 Operating time
display
12 Timer reset button
Momentarily depressing this touch button decreases the aspiration level and display
by one digit. Constant depression will cause the aspiration display to decrease
continuously until the finger pressure is removed or until the minimum setting (a
blank display) is obtained.
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.
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.
Momentarily depressing this touch button decreases the irrigation display by 1
digit. Constant depression will cause the irrigation display to decrease continuously
until the finger pressure is removed or until the minimum setting (a blank display)
is obtained.
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.
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.
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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SELECTOR® INTEGRA Operator Manual
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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) no handpiece connected
b) 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).
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.
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.
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.
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.
This is an international symbol referring the user to the instruction manual for
detailed Instructions.
This is an international symbol indicating the equipment has been specifically
designed to meet type CF (Cardiac Floating) safety standards.
This is a graphic symbol to represent the handpiece connection.
13 Handpiece error
warning
14 Tip error warning
15 24kHz handpiece
connection socket
16 35kHz handpiece
connection socket
18 Symbol
19 Symbol
20 Symbol
17 MicroSurgical
handpiece socket
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Console Left
Side Panel
The components and connection points on the left side panel are illustrated and
described below.
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.
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.
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.
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.
1 Irrigation pump
2 Aspiration Filter
connection port
3 Pinch valve
4 Footswitch socket
13
4
2
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SELECTOR® INTEGRA Operator Manual
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The components and connection points on the rear panel are illustrated and
described below.
An international standard inlet which accepts the power cord supplied with the
instrument.
A rocker switch which is switched from the off (marked ‘0’) position to the on (marked
‘I’) position to power the instrument.
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.
Console Rear Panel
1 Mains inlet
2 Power switch
2
SPEMBLY MEDICAL LTD.
3 Fuseholder
14
8
7
6
3 5
SELECTOR® INTEGRA ULTRASONIC SURGICAL ASPIRATOR
1530000
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SELECTOR® INTEGRA Operator Manual
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A socket providing output power which accepts the power lead from the accessory
SELECTOR® INTEGRA Service Module.
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.
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.
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).
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.
4 Service Module
power outlet
5 Cooling fan air outlet
6 Ground point
7 Vacuum pressure
gauge
8 Irrigation pole
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SELECTOR® INTEGRA Operator Manual
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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).
Footswitch
17