Integra SELECTOR Bedienungsanleitung

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

SELECTOR® INTEGRA Operator Manual

Issue C168-5

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

SELECTOR® INTEGRA Operator Manual

Issue C168-5

1 INTRODUCTION

1.1 Summary of

Operating Safety

Precautions

Handling of the

Handpiece

Backup Handpiece

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.

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

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.

SELECTOR® INTEGRA Operator Manual

Issue C168-5

SELECTOR® INTEGRA Operator Manual

Issue C168-5

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

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.

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

SELECTOR® INTEGRA Operator Manual

Issue C168-5

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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