Gyrus Acmi PlasmaKinetic User manual

PlasmaKineticSuperPulse Generator
USER MANUAL
Manufactured for:
Gyrus ACMI,
136 Turnpike Road
Southborough
MA 01772-2104
USA
Gyrus Medical Ltd
St Mellons
Cardiff
CF3 0LT
United Kingdom
Rx only
Customer Service USA:
Customer Service: 1-888-524-7266
Technical Service: 1-800-621-3739
www.gyrusacmi.com
744000 Part Number: 114020-LB
2011-02
0344

………OVERVIEW OF THE GYRUS ACMI SUPERPULSE GENERATOR
Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology) USER MANUAL Overview
Part Number: 144020-LB
This user manual will familiarize you with the controls and output functions available from your Gyrus ACMI
SuprePulse Generator and instruct you on its proper use.
Copyright Gyrus Medical, Ltd. 2010. All rights reserved. No part of this
publication may be reproduced, transmitted, transcribed, stored
in retrieval systems, or translated into any language or computer
language, in any form, or by any means: electronic, mechanical,
magnetic, optical, or otherwise, without the prior written
permission of Gyrus ACMI.
Patents This product may be covered by one or more of the following US
patents:
5,944,715; 6,004,319; 6,013,076; 6,015,406; 6,045,549;
6,056,746; 6,074,386, 6,090,106, 6,093,186; 6,152,143;
6,131,579; 6,179,803; 6,210,355; 6,210,405; 6,228,081;
6,234,178; 6,261,286; 6,293,942; 6,303,134; 6,364,877;
6,416,491; 6,416,509; 6,482,202; 6,517,535; 6,371,926;
6,682,501, 6,893,435,6,984,231, 7,214,224, 7,211,081,
7,195,627.
Associated Patents are in place in other countries
OVERVIEW OF THE GYRUS ACMI SUPERPULSE GENERATOR
The Gyrus ACMI SuperPulse Generator forms a versatile platform for Urology and General surgical use.
Ensure that the contents of this User Manual are read and understood before proceeding to use the
Gyrus ACMI SuperPulse Generator.
OVERVIEW OF THE GYRUS ACMI SUPERPULSE GENERATOR

……………………………….TABLE OF CONTENTS .
Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology) USER MANUAL
Part Number: 144020-LB
SECTION PART PAGE .
1INTRODUCTION
1A Overview of the Superpulse System 1-1
1B Comparison with Conventional Surgery 1-1
1C Indications for Use 1-2
1D Contraindications for Use 1-2
1E System Description 1-2
2 PATIENT AND OPERATING ROOM SAFETY
2A General 2-1
2B. Servicing/Equipment Disposal 2-2
2C Fire/Explosion 2-3
2D Before Surgery 2-3
2E During Surgery 2-4
2F After Surgery 2-6
2G EMC Classification 2-6
3 INSTALLATION
3A Responsibility of the Manufacturer 3-1
3B SuperPulse Generator Power Requirements 3-1
3C Grounding of the SuperPulse Generator 3-1
3D. Routine Maintenance of the SuperPulse Generator 3-1
4 GENERAL INFORMATION
4A SuperPulse Generator Indicators and Displays 4-1
4B Output Mode Selection Power Controls 4-3
4C Olympus TURis Mode 4-5
4D SuperPulse Generator Indicators, Set-up and Malfunction Displays 4-7
4E Changing the Display Language 4-10
4F Enabling Additional Instruments via a PIN code 4-11
5 BEFORE SURGERY
5A Power up the SuperPulse Generator 5-1
5B Select the Appropriate PK/SP Instrument(s) for the Procedure 5-2
5C Steam Sterilise the PK Connector Cable, PlasmaKineticResectoscope or
appropriate urological endoscope 5-4
5D Connect the PK Connector Cable 5-4
5E Prepare the PlasmaKineticResectoscope or urological endoscope 5-4
5F Attach PlasmaKineticInstrument to the PK Connector Cable 5-8
6 DURING SURGERY
6A Accessories 6-1
6B Recommendations during Surgery 6-1
7 TECHNIQUES TO OPTIMIZE PERFORMANCE 7-1
8 AFTER SURGERY
8A Following Surgery Involving PlasmaKineticResectoscope Instruments 8-1
8B Following Surgery Involving PlasmaKineticCystoscope Instruments 8-1
8C Following all Surgery Involving the Superpulse Endourology
System 8-2
9 OPERATING ROOM TROUBLESHOOTING 9-1
10 PERFORMANCE SPECIFICATIONS 10-1
11 ERROR AND FAULT CODES 11-1
12 EXPLANATION OF SYMBOLS 12-1
13 PERIODIC EQUIPMENT SAFETY CHECKS 13-1
14 EMC TABLES 14-1
15 LIMITED WARRANTY 15-1
TABLE OF CONTENTS

SECTION 1 INTRODUCTION
Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology) USER MANUAL
Part Number: 144020-LB
Gyrus Medical Ltd, Gyrus Medical Inc and Gyrus ACMI Inc are referred to as Gyrus ACMI in this user
manual.
This user’s manual will familiarise you with the controls and output functions available from your SuperPulse
System and instruct you on its proper use.
1A. Overview of the SuperPulse System
An endoscope is an instrument routinely employed to visualise and access the interior of various body
cavities for the purposes of both diagnostic and surgical procedures. The endoscope is inserted
through a natural body opening, such as the cervical canal or urethra. The instrument commonly
includes one or more integral working channels for the passage of surgical instruments, as well as
conduits for the passage of gas or liquid required to distend the body cavity. Commonly referred to as
‘underwater surgery’, liquid distension is usually the preferred method in urological endoscopy.
Electro surgery is a familiar tool widely employed in urological endoscopy to perform transurethral
prostatectomy (TURP), resection of bladder tumours and cystodiathermy. Based on similar principles,
the PlasmaKinetictechnology exploits the electrical conductive properties of fluid used to distend the
operative site, requiring the standard non-electrolyte irrigation fluids used during conventional TURP
to be replaced by normal saline. By adjusting power in microseconds two tissue effect modes can be
produced. In the first mode, an ionised plasma corona is created over the active zone of a tissue
treatment electrode. Tissue entering the intense kinetic energy of the corona is instantly reduced to its
constituent elements and simply washed away in the irrigation fluid. The low thermal mass of the
plasma prevents collateral tissue damage adjacent to the application site. In the second mode, rapid,
predictable and controlled elevations in tissue temperature can be produced to ablate tissue or seal
blood vessels.
The SuperPulse mode of operation enables very rapid formation of the plasma enabling easier and
more rapid resection of tissue.
1B. Comparison with Conventional Electrosurgery
Conventional bipolar electrosurgery requires that both ‘poles’ of the electrode contact tissue to
complete the electrical circuit and produce a tissue effect. Typically, these electrodes do not operate
effectively while immersed in a conductive irrigating solution such as normal saline. The Gyrus ACMI
SuperPulse Endourology System utilises the fact that saline is electrically conductive to control an
ionised plasma around the active tip when electrosurgical current is applied. Essential to this design is
the proximity of the return electrode to the active electrode in an AxipolarTM configuration. The fact
that the two poles of the circuit are only a few millimetres apart means that current flows only through
the irrigant or through the tissue to be vaporised. This localised current flow preserves the recognised
safety features of conventional bipolar electrosurgery. Similarly, this arrangement avoids many of the
problems commonly encountered when using bipolar electrosurgery: orientation of the electrode to
tissue, visualisation of the working tip, tissue sticking and limited power delivery.
The intense concentration of electrosurgical energy delivered by the technology offers instantaneous
vaporisation of tissue. This effect can be achieved with monopolar electrosurgery but at very high
power levels and only in the presence of a non-electrolyte irrigating solution, both aspects of which
have recognised complications and safety concerns. Furthermore, the deep tissue heating of
monopolar arrangements which occurs during tissue vaporisation causes a progressive deterioration
in efficiency over the period of the procedure. The PlasmaKinetictechnology overcomes this
problem and provides a repeatable tissue effect throughout the procedure. In order for the system to
produce this effect, the SuperPulse Generator has integral feedback systems to both initiate and
sustain the plasma corona around the active electrode.
The instruments can only operate within a saline medium. The size of the working tip geometry
determines the amount of power needed to ensure optimal performance. To simplify set-up the
Page 1-1
SECTION 1 INTRODUCTION