plasmakinetic_superpulse_generator_user_manual_feb_.pdf
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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
0344
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
Page 3
………OVERVIEW OF THE GYRUS ACMI SUPERPULSE GENERATOR
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.
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.
Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)
Part Number: 144020-LB
USER MANUAL
Overview
OVERVIEW OF THE GYRUS ACMI SUPERPULSE GENERATOR
Copyright
Page 4
……………………………….TABLE OF CONTENTS
.
SECTION
PART
1
INTRODUCTION
Overview of the Superpulse System
1-1
Comparison with Conventional Surgery
1-1
Indications for Use
1-2
Contraindications for Use
1-2
System Description
1-2
PATIENT AND OPERATING ROOM SAFETY
General
2-1
Servicing/Equipment Disposal
2-2
Fire/Explosion
2-3
Before Surgery
2-3
During Surgery
2-4
After Surgery
2-6
EMC Classification
2-6
INSTALLATION
Responsibility of the Manufacturer
3-1
SuperPulse Generator Power Requirements
3-1
Grounding of the SuperPulse Generator
3-1
Routine Maintenance of the SuperPulse Generator
3-1
GENERAL INFORMATION
SuperPulse Generator Indicators and Displays
4-1
Output Mode Selection Power Controls
4-3
Olympus TURis Mode
4-5
SuperPulse Generator Indicators, Set-up and Malfunction Displays
4-7
Changing the Display Language
4-10
Enabling Additional Instruments via a PIN code
4-11
BEFORE SURGERY
Power up the SuperPulse Generator
5-1
Select the Appropriate PK/SP Instrument(s) for the Procedure
5-2
Steam Sterilise the PK Connector Cable, PlasmaKinetic Resectoscope or
appropriate urological endoscope
5-4
Connect the PK Connector Cable
5-4
5-4
Prepare the PlasmaKinetic Resectoscope or urological endoscope
Attach PlasmaKinetic Instrument to the PK Connector Cable
5-8
DURING SURGERY
Accessories
6-1
Recommendations during Surgery
6-1
TECHNIQUES TO OPTIMIZE PERFORMANCE
7-1
AFTER SURGERY
Following Surgery Involving PlasmaKinetic Resectoscope Instruments 8-1
Following Surgery Involving PlasmaKinetic Cystoscope Instruments
8-1
Following all Surgery Involving the Superpulse Endourology
System
8-2
OPERATING ROOM TROUBLESHOOTING
9-1
PERFORMANCE SPECIFICATIONS
10-1
ERROR AND FAULT CODES
11-1
EXPLANATION OF SYMBOLS
12-1
PERIODIC EQUIPMENT SAFETY CHECKS
13-1
EMC TABLES
14-1
LIMITED WARRANTY
15-1
1A
1B
1C
1D
1E
2
2A
2B.
2C
2D
2E
2F
2G
3
TABLE OF CONTENTS
3A
3B
3C
3D.
4
4A
4B
4C
4D
4E
4F
5
5A
5B
5C
5D
5E
5F
6
6A
6B
7
8
8A
8B
8C
9
10
11
12
13
14
15
Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)
Part Number: 144020-LB
PAGE
USER MANUAL
.
Page 5
SECTION 1
INTRODUCTION
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
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.
SECTION 1
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.
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
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
Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)
Part Number: 144020-LB
USER MANUAL
Page 1-1
INTRODUCTION
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.
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SECTION 1
INTRODUCTION
SECTION 1
SuperPulse Generator will automatically select a default power and mode setting according to the
instrument type. Power and mode adjustments can be performed by the front panel buttons with the
selected output shown on the user display.
Instruments are supplied in a sterile, single use format and connect to the SuperPulse Generator via a
limited re-use connector cable. Activation of the electrosurgical current is by means of a footswitch,
attached via the back panel. Activation is inhibited by safety circuitry until both instrument and
connector cable have been properly coupled to the SuperPulse Generator. An audible alarm will
sound whenever electrosurgical energy is being output. Diagnostic circuits within the SuperPulse
Generator continuously monitor system performance. Any detected faults are indicated as symbols on
the user display in conjunction with the illumination of the front panel warning symbol.
1 C. Indication for Use
The Gyrus ACMI PK Superpulse System is intended for use for ablation, removal, resection and
coagulation of soft tissue and where associated haemostasis is required in open, endoscopic and
laparoscopic surgical procedures.
The device is intended for use by qualified medical personnel trained in the use of electrosurgical
equipment.
1D.
Contraindications for Use
The use of this device is contraindicated in patients with the following conditions:
Carcinoma of the bladder or prostate without tissue diagnosis.
Patients with urinary tract infection.
Patients with incipient renal failure.
It is advisable to monitor the input and output volumes of the irrigation fluid in all patients but
especially those with cardiovascular insufficiency or poor renal function.
Patients with Pacemakers
Use with caution in the presence of internal or external pacemakers. Interference from an
electrosurgical current can cause a pacemaker to enter an asynchronous mode or can block the
pacemaker effect entirely. For further information, consult the pacemaker manufacturer or hospital
Cardiology Department.
INTRODUCTION
1E.
System Description
The SuperPulse Endourology System (figure 1.1) is designed for resectoscopic and endoscopic
urological procedures performed on the lower urinary tract. A typical system comprises the following
items:
A SuperPulse Generator (Model 744000)
A Gyrus ACMI Footswitch (Model 744010)
Suitable connector cable to connect to the Gyrus or Olympus Resectoscope.
Use only approved accessories - Contact your sales representative.
When used with a PlasmaKinetic Resectoscope
A suitable Gyrus ACMI Urology Electrode (e.g. PK Plasma Sect, PK SuperSect, Superloop
and PK Button) (see Fig 1.2)
When used with a suitable urological endoscope (e.g. Cystoscope)
A PK Plasma-Cise or PK Plasma Cut instrument (see Fig 1.3)
When used with an approved Resectoscope
Olympus Electrodes – Compatible with the Gyrus ACMI SuperPulse System.
Supplied with connector cable
Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)
Part Number: 144020-LB
USER MANUAL
Page 1-2
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SECTION 1
INTRODUCTION
Typical Resectoscope Components
Working Element Active
- Or Working Element Passive
Telescope
Inner sheath
Outer sheath
- Or Outer sheath rotatable
SECTION 1
Standard Obturator
Olympus Light Guide Adapter
Visual Obturator
Ellik Evacuator Adapter
Continuous Flow Sheath
Resectoscope Sheath (24 Fr. Intermittent Sheath)
The instruments are available in three basic forms.
The resectoscope Instruments (figure 1.2) are designed to be used in conjunction with the
PlasmaKinetic resectoscope which is designed to accept the instrument which is connected directly
to the connector cable rather than to the resectoscope. Typical use of these types of instruments
would be in the surgical treatment of benign prostatic hyperplasia.
The cystoscope Instruments (figure 1.3) are intended for insertion through the working channel of any
standard, commercially available urological endoscope with a 5Fr. or larger working channel. Typical
use of these instruments would be for the desiccation and vaporisation of recurrent bladder tumours.
In addition certain Olympus TURis instruments can also be used (see Fig 1.5)
Instruments are designed to provide either vaporisation or desiccation of tissue, using the yellow and
blue pedals respectively, of the dual footswitch. The vaporization is achieved with “SuperPulse” (SP)
mode or “PlasmaKinetic” (PK) modes, depending on instrument type. Desiccation uses the
Desiccated (DES) mode. A third mode is also available, the ThermoKineticTM mode (TS or T).
This mode provides either modulated “SuperPulse” (TS) or a blend of PlasmaKinetic and Desiccate
(T) electrosurgical currents and offers a reduced vaporisation effect but with enhanced hemostatic
effect.
Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)
Part Number: 144020-LB
USER MANUAL
Page 1-3
INTRODUCTION
Fig 1.1 Example System
Page 8
SECTION 1
INTRODUCTION
.
Fig 1.2
Example of Gyrus ACMI Resectoscopic Instruments – For use with Reusable Cable
SECTION 1
Fig 1.3
Example of Gyrus ACMI Resectoscopic instruments with Disposable Cable
INTRODUCTION
Fig 1.4
Example of Gyrus ACMI Cystoscopic Instruments.
Fig 1.5
Examples of Olympus Resectoscopic Instruments
A specific TURis mode is only available when a TURis cable is connected to the SuperPulse Generator.
Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)
Part Number: 144020-LB
USER MANUAL
Page 1-4
Page 9
SECTION 2
PATIENT AND OPERATING ROOM SAFETY
The safe and effective use of electrosurgery depends to a large degree upon factors and variables solely
under the control of the operator. There is no substitute for good surgical technique and properly trained
operating room staff. It is important that the operating instructions supplied with this or any electrosurgical
equipment be read, and understood, and followed.
Electrosurgery has been employed safely in numerous procedures. Before starting any surgical procedure
the physician should be familiar with the medical literature, complications and hazards of electrosurgery in
that procedure.
2A.
SECTION 2
For the purposes of safety procedures and despite the absence of a conventional return pad, the Gyrus
ACMI SuperPulse Endourology System should still be treated as a high power electrosurgical device.
General
Hazardous Electrical Output: This equipment is for use only by qualified personnel. Use
only approved accessories.
WARNING
Do not use a monopolar generator/accessories simultaneously with the SP generator.
Activation of a monopolar generator/accessories may cause interference with the SP
generator resulting in user message changes on the display. Before proceeding with
surgery, confirm proper power settings are displayed on the generator. Ensure the
appropriate output setting is enabled for the desired surgical outcome.
WARNING
Direct contact between activated monopolar accessories and SP generator connected
accessories could damage the SP generator. If such damage is suspected, the SP
generator should be returned to Gyrus ACMI for inspection.
WARNING
Use with caution in the presence of internal or external pacemakers. Interference from
an electrosurgical current can cause a pacemaker to enter an asynchronous mode or
can block the pacemaker effect entirely. For further information, consult the pacemaker
manufacturer or hospital Cardiology Department.
WARNING
Do not use electrosurgical equipment unless properly trained in its use in the specific
procedure intended.
WARNING
Electrodes and probes used with monitoring, stimulation, and imaging devices (or
similar equipment) can provide a path for high frequency current even if they are
isolated. To reduce the risk of an inadvertent burn at the electrode site, place the
electrode and / or probe as far away as possible from the electrosurgical site.
WARNING
ONLY USE 0.9% w/w SALINE FOR IRRIGATION.
Performance will be suppressed by use of other irrigating solutions such as Glycine,
Sorbitol, Dextrose, Mannitol or other solutions containing non-physiological
concentrations of electrolyte
CAUTION
If two accessories are connected to the SP generator, ensure the appropriate accessory
is selected prior to activation. Activation of the unintended accessory could cause
unintentional tissue effect.
CAUTION
Do not activate electrodes while in contact with other instruments as unintended tissue
effect may occur.
CAUTION
Do not activate the generator in an open circuit condition, this may result in excessive
heating of the irrigation medium. To reduce the risk of unintended effects, activate the
generator only when the active accessory is near or touching the target tissue.
Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)
Part Number: 144020-LB
USER MANUAL
Page 2-1
PATIENT AND OPERATING ROOM SAFETY
WARNING
Page 10
PATIENT AND OPERATING ROOM SAFETY
CAUTION
Do not apply excessive pressure to the accessory tip during use as damage may result.
CAUTION
Use the lowest appropriate power setting to achieve the desired effect.
CAUTION
This equipment is capable of producing a physiological effect.
CAUTION
Read the instructions, cautions, and warnings provided with Gyrus ACMI SuperPulse
Endourology System accessories before use. This device is an integral system; only
use approved accessories with the Superpulse Generator. Your sales representative
can advise which accessories are available and approved for use with the Superpulse
System.
CAUTION
If possible, avoid the use of needle style instruments for any physiological monitoring
equipment that may be connected to the patient during electrosurgery.
CAUTION
Where practical; only use monitoring equipment that incorporates high frequency
current limiting devices during electrosurgical procedures.
CAUTION
The connector cable should be positioned so that it avoids contact with the patient and
any other leads.
CAUTION
Studies have shown that electrosurgical smoke generated during electrosurgical
procedures can be potentially harmful to surgical personnel.
CAUTION
Examine all accessories and connections to the electrosurgical SuperPulse Generator
before use. Improper connection may result in arcs and sparks, accessory malfunction,
or unintended surgical effects.
CAUTION
Do not insert fingers or objects other than the correct cables into the socket. Only
activate the footswitch with an instrument attached.
SECTION 2
SECTION 2
PATIENT AND OPERATING ROOM SAFETY
WARNING
CAUTION
2B.
The PK or SP system has not been cleared for tubal sterilization. Do not use this
system for these procedures.
The Gyrus ACMI SuperPulse Endourology System should only be activated with the
working tip of the instrument completely immersed in 0.9% w/v 150mMol/l sodium
chloride solution. For convenience, this will be referred to within the remainder of this
manual as normal saline.
Servicing/Equipment Disposal
CAUTION
Electrical Shock Hazard: Do not tamper with the SuperPulse Generator housing or
attempt to remove the control panel. Refer to authorised personnel for service.
NOTE
1. There are no user serviceable parts within the product.
2. For maintenance of the SuperPulse Generator refer to
recommended periodic equipment safety checks in Section 13.
the
CAUTION
The SuperPulse Generator contains electronic printed circuit assemblies. At the end of
the useful life of the equipment it should be disposed of in accordance with any
applicable policies relating to obsolete electronic equipment.
CAUTION
Dispose of any system accessories according to normal institution practice relating to
disposal of biologically contaminated items.
Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)
Part Number: 144020-LB
USER MANUAL
Page 2-2
Page 11
SECTION 2
2C.
PATIENT AND OPERATING ROOM SAFETY
Fire/Explosion
Explosion Hazard: Do not use in the presence of flammable anaesthetics.
WARNING
Explosion Hazard: The following substances will contribute to increased fire and
explosion hazards in the operating room:
Flammable substances (such as alcohol based skin prepping agents and
tinctures)
Flammable agents used for cleaning or disinfecting, or as solvents of
adhesives should be allowed to evaporate before the application of
electrosurgery. There is a risk of pooling of flammable solutions under the
patient or in body cavities during endoscopic surgery. Any fluid pooled in
these areas should be mopped up before electrosurgery is used.
Endogenous gases.
Flammable anesthetics or oxidizing gases such as nitrous oxide (N2O) and
oxygen enriched atmospheres.
Some materials, for example cotton, wool and gauze, when saturated with
oxygen may be ignited by sparks produced in normal use of electrosurgical
equipment.
The sparking and heating associated with electrosurgery can provide an ignition source. Observe fire
precautions at all times.
WARNING
2D.
Fire/Explosion Hazard: Verify that all oxygen circuit connections are leak free
before and during use of electrosurgery. When using electrosurgery in the same
room with any of the above substances or gases, prevent their accumulation or
pooling under surgical drapes, or within the area where electrosurgery is being
performed.
Before Surgery
Active Accessories
WARNING
Electric Shock Hazard: Do not connect wet accessories to the SuperPulse Generator.
WARNING
Electric Shock Hazard: Ensure that all accessories are correctly connected and that no
metal is exposed.
WARNING
Do not attempt to re-use instruments labelled for Single Use Only. Heat or chemical
Sterilization may render the instrument mechanically or electrically unsafe
CAUTION
Read the instructions, warnings and cautions provided with the active accessories
before using.
CAUTION
Accessories labelled re-usable must only be processed according to the recommended
procedure and, where appropriate, recycled the specified number of times.
CAUTION
Use default power levels to test an accessory.
Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)
Part Number: 144020-LB
USER MANUAL
Page 2-3
PATIENT AND OPERATING ROOM SAFETY
SECTION 2
DANGER
Page 12
PATIENT AND OPERATING ROOM SAFETY
CAUTION
Use only approved accessories supplied for use with this product. Product damage or
accessory failure may otherwise result during use. Your sales contact can advise what
accessories are available.
CAUTION
Always inspect the system accessories for damage prior to use. In particular, check the
cables of any re-usable accessory for possible insulation damage.
SECTION 2
SECTION 2
SuperPulse Generator
PATIENT AND OPERATING ROOM SAFETY
2E.
WARNING
Electric Shock Hazard. Connect the generator power cord to a properly grounded
receptacle. Do not use power plug adapters.
WARNING
Fire Hazard. Do not use extension cords.
CAUTION
Provide as much distance as possible between the SuperPulse Generator and other
electronic equipment (such as monitors) as an activated SuperPulse Generator may
cause interference with them.
CAUTION
Non-function of the SuperPulse Generator may cause interruption of surgery. Ensure
that all installation procedures are followed and that all connectors are correctly inserted
before use. A backup generator should be available for use.
CAUTION
Do not stack equipment on top of the generator or place the generator on top of
electrical equipment.
CAUTION
Do not set the activation tone down to an inaudible level. The activation tone alerts
surgical personnel when an accessory is active.
During Surgery
Contact With Metal Objects
WARNING
Use extreme caution when using electrosurgery in close proximity to or in direct contact
with any metal objects. The working channel and operating sheaths of most rigid
endoscopes are metal. Do not activate the instrument while any portion of the
instrument tip is within the sheath or working channel, or in contact with another metal
object. Localised heating of the instrument and the adjacent metal object or working
channel may result in damage to the contacting endoscope, and/or instrument tip.
WARNING
While using electrosurgery during a surgical procedure, the patient should not be
allowed to come into direct contact with grounded metal objects (e.g., surgical table
frame, instrument table, etc.). If this is not possible, use extreme caution to maximise
patient safety. The use of antistatic sheeting is recommended for this purpose.
WARNING
Risk of injury to patient: Thermal cell damage can occur when using
preheated irrigation fluid. Always make sure that the temperature of the irrigation fluid
does not rise above body temperature (37 °C/99 °F).
Risk of injury to patient: Localised excessive heating of the irrigation fluid can be caused
by HF current. Always make sure to use a sufficient flow rate (minimum 1 litre/5 min).
WARNING
Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)
Part Number: 144020-LB
USER MANUAL
Page 2-4
Page 13
SECTION 2
PATIENT AND OPERATING ROOM SAFETY
SuperPulse Generator Power Settings
CAUTION
Upon reconnection of an instrument to the electrosurgical SuperPulse Generator, or after
navigation using the Mode / Menu button, the power settings for cutting and coagulation
may be changed from previously selected values.
WARNING
Do not simultaneously activate the SuperPulse Generator whilst activating with any
other electrosurgical equipment (on the same patient). Failure to observe this may
result in the attached instrument being unrecognized by the system.
CAUTION
Failure of the HF SURGICAL EQUIPMENT could result in an unintended increase or
decrease in output power.
CAUTION
Use caution when overriding the default power settings.
CAUTION
Should a power supply interruption occur, the generator will revert to its Standby state.
The user should press the Standby / On button to restart the generator and then press
the Mode / Menu button to accept the default instrument settings.
Instrument Accessories
WARNING
When not in use, place active instruments in a clean, dry, non-conductive, and highly
visible area not in contact with the patient. Inadvertent activation while in contact with
the patient may result in burns.
WARNING
Do not wrap accessory cords around metal objects. This may induce currents that
could lead to injury to the patient or surgical personnel.
WARNING
Fire Hazard: Do not place active accessories near or in contact with flammable
materials (such as gauze or surgical drapes). Electrosurgical accessories which are
activated or hot from use can cause a fire.
Endoscopic Procedures
WARNING
As visualisation may be impaired during endoscopy for a number of reasons, be
particularly alert to these potential hazards:
Ensure the tip of the instrument is visible before activation.
The instrument tip may remain hot enough to cause burns after the
electrosurgical current is deactivated.
Inadvertent activation or movement of activated instruments outside of the
field of vision may result in injury to the patient.
Localised burns to the patient or physician may result from electrical
currents carried through conductive objects. Electrical current may be
generated in conductive objects by direct contact with the active instrument,
or by the active or return instrument being in close proximity to the
conductive object whilst activated.
Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)
Part Number: 144020-LB
USER MANUAL
Page 2-5
PATIENT AND OPERATING ROOM SAFETY
Confirm proper power settings are displayed on the SuperPulse Generator before
proceeding with surgery. Ensure the appropriate output setting is enabled for the
desired surgical outcome before activating the instrument and ensure that activation is
for the minimum time to achieve the desired surgical effect.
SECTION 2
WARNING
Page 14
SECTION 2
SECTION 2
PATIENT AND OPERATING ROOM SAFETY
2F.
2G
PATIENT AND OPERATING ROOM SAFETY
Carefully insert and withdraw active instruments from sheaths and working
channels to avoid the possibility of damage to the devices and/or injury to
the patient.
Only activate during intermittent or preferably continuous flow irrigation to
ensure good visualisation and cooling of the instrument tip between
activations.
The vaporisation process produces bubbles. Activation of the instrument tip
within a bubble pocket may cause product damage.
Only use normal saline irrigation solution. Do not activate when not in
contact with tissue, or excessive heating of the irrigation medium may result.
Tissue contact with the return instrument whilst the active instrument is
surrounded by normal saline during activation may result in an
electrosurgical effect occurring at the return instrument.
CAUTION
Proper use of the system relies on tissue contact with the active tip of the
instrument only. Do not bury the tip in tissue beyond the junction of the active
instrument and the ceramic insulator as product damage may result during use.
WARNING
Olympus TURis Mode
Incorrect assembly and connection of the Olympus Resectoscopic system and
electrode may result in no RF surgical output.
IMPORTANT
TURis compatibility is only available with SuperPulse software version V3.0
software and later.
After Surgery
WARNING
Electric Shock Hazard. Always unplug the generator before cleaning.
CAUTION
Do not reuse or resterilize accessories labelled “disposable” or “single use only.”
EMC Classification
The SuperPulse System has been manufactured and tested to the following requirements:
Group 2 Class A as per IEC60601-1-2 (2001)
EMC PRECAUTIONS
Medical electrical equipment needs special precautions regarding EMC and needs to be installed and
put into service according to the EMC information in this document.
EMC WARNINGS
•
The generator should not be used adjacent to or stacked with other electrical equipment. If
adjacent or stacked use is necessary both the generator and other equipment should be observed
to verify normal operation in the configuration in which it will be used.
•
The EMC classification of the SuperPulse system (class A) is suitable for use on dedicated supply
systems not connected to the public mains network, such as hospitals.
Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)
Part Number: 144020-LB
USER MANUAL
Page 2-6
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SECTION 2
PATIENT AND OPERATING ROOM SAFETY
Portable and mobile RF communications equipment can affect medical electrical equipment.
•
The use of accessories and cables other than those for which the system was designed can
significantly degrade emissions and immunity performance.
•
Keep the accessory cables away from cables from other electrical equipment. Electrical currents
may be induced in the other equipment causing unintended effects.
•
Do not use a monopolar generator/accessories simultaneously with the SuperPulse generator.
Activation of a monopolar generator/accessories may cause interference with the SuperPulse
generator resulting in user message changes on the display. Before proceeding with surgery,
confirm proper power settings are displayed on the generator. Ensure the appropriate output
setting is enabled for the desired surgical outcome.
•
Provide as much separation as possible between the generator and other electronic equipment
(such as monitors). When activating the generator, unintended electromagnetic coupling may
cause interference with the other equipment.
•
Should any unintentional effects appear upon other equipment when using the generator,
repositioning the generator, the connecting leads or other equipment may alleviate the problem. It
may also help to use different electrical supply sockets for any affected equipment
Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)
Part Number: 144020-LB
USER MANUAL
Page 2-7
PATIENT AND OPERATING ROOM SAFETY
•
SECTION 2
NOTE: Although class A limits have been derived for industrial and commercial establishments,
administrations may allow, with whatever additional measures necessary, the installation
and use of class A ISM equipment in a domestic establishment or establishment
connected directly to domestic electricity power supplies.
Page 16
SECTION 3
INSTALLATION
The SuperPulse Generator described in this manual, in conjunction with the available accessories, is
designed to be used as a system to provide advanced electrosurgical effects during endoscopic urological
surgery under normal saline irrigation.
3A. Responsibility of the Manufacturer
The manufacturer is responsible for safety, reliability and performance of the equipment only if:
SECTION 3
Installation procedures in this manual are followed.
Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by
persons authorised by the manufacturer and the electrical installation of the relevant operating
room complies with local codes and regulatory requirements.
The equipment is used in accordance with this User Manual, the Instructions For Use which
accompany all system components and any additional information contained on the component
package labelling.
3B. SuperPulse Generator Power Requirements
Please refer to section 10-1 for full voltage detail.
Check the SuperPulse Generator Power Connection
The power connector meets all requirements for safe grounding. Its purpose should not be defeated
by using extension cords or any form of adapter. When disconnecting from the mains socket or from
the SuperPulse Generator, cords should always be grasped by the plug. Do not pull on the cord itself.
3C. Grounding of the SuperPulse Generator
To ensure user safety the SuperPulse Generator must be properly grounded through the inlet plug
and power cord. Use only hospital grade power cords.
INSTALLATION
IMPORTANT
3D.
Ensure that the electrical installation of the relevant room complies with local
codes and regulatory requirements.
Routine Maintenance of the SuperPulse Generator
It is recommended that the SuperPulse Generator be inspected by qualified service personnel in
accordance with Section 13, Periodic Equipment Safety Checks.
Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)
Part Number: 144020-LB
USER MANUAL
Page 3-1
Page 17
SECTION 4
4A.
GENERAL INFORMATION
Gyrus ACMI SuperPulse Generator Indicators and Displays
Red warning
lamp
Gyrus Medical Ltd
Superpulse System
(c) 2003
Version V2.00
Standby / Standby / On
On Button
indicator
SECTION 4
PlasmaKinetic,
SuperPulse and
ThermoKinetic Up/Down
Mode /
Menu
Button
Active instrument
indicator
Connector Cable
sockets
Vapor Pulse and Des
Up/Down
Fig 4. 1
Keypad: Standby/On, Up, Down Arrows and Mode / Menu Button
Standby / On
Following an error condition the generator may be reset by pressing the Standby / On
button twice.
Up/Down Arrows
Depressing the up or down arrow when parameter change is permitted increases or
decreases the parameter step-wise. Holding the button down will increase or decrease
the value in preset steps
Mode / Menu
This button provides access into the waveform selection and setup menus.
Repeated short presses will give access to the frequently used functions, listed below:
Cut waveform selection (PK / SP)
Coagulation waveform selection (VP / DES)
Volume
Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)
Part Number: 144020-LB
USER MANUAL
Page 4-1
GENERAL INFORMATION
The Standby/On button switches the Generator back and forth between the Standby and
Idle / Ready states. The green indicator will change from flashing to continuous when the
equipment mode changes from Standby to Idle / Ready states by pressing the button. To
place the generator into Standby press the standby button. When prompted press again
to confirm entry to Standby is required
Page 18
SECTION 4
GENERAL INFORMATION
A long press will give access to the setup menu, giving access to the following functions
below with repeated short presses:
NOTE
Display intensity
Key click on/off
Select language
Enter PIN Code
If there is no user activity for a short period, the generator will exit the menu
and return to Idle / Ready state.
SECTION 4
When a PK connector cable is attached, the symbol below appears on the display.
3 Way Cable
Attached
Insert Device
Fig 4.2 Screen for 3-Way PK cable installed on the selected socket.
Output Displays for SP/ PK Instruments
GENERAL INFORMATION
The display is split into two halves; the upper portion of the display is used to indicate the
type of instrument active, that is the instrument that will provide an output when the Cut or
Coag pedal is pressed. The lower half of the display indicates the output waveform type, or
mode, and the power selected.
The left lower portion displays the mode selected and, underneath, the power level that will
be active when the Cut pedal is depressed. This is dependent upon the type of instrument
used, its default setting properties and any user power level adjustments.
When a Plasmakinetic (PK) instrument is used one of ‘PK1’, ‘PK2’ or ‘PK3’ is shown for
the mode, the power setting can be from 10 to 200.
When a SuperPulse (SP) instrument is used one of ‘SP1’, ‘SP2’, ‘SP3’ is shown for the
mode, the power setting can be from 10 to 320.
When the ThermoKinetic mode is selected ‘TS1’, ‘TS2’, ‘T1’ or ‘T2’ is shown.
The right portion displays desiccate (VP or DES), with the default power setting from 10 to
120 dependent on the type of Gyrus ACMI PK instrument attached. This is the power level
that will be active when the Coag pedal is depressed.
The appropriate display will flash and an audible alarm will sound when an output is
activated.
Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)
Part Number: 144020-LB
USER MANUAL
Page 4-2
Page 19
SECTION 4
GENERAL INFORMATION
SuperLoop
SP2
160
Des
80
SECTION 4
Fig 4.3 Screen for SuperLoop instrument selected
Output Displays for SP Instruments
The display will operate as per PK instruments with the PK waveforms replaced by their SP
alternates.
IMPORTANT
4B.
SuperPulse (SP) mode can only be used with Gyrus ACMI SuperPulse
compatible instruments (SuperSect, SuperLoop and SuperV
instruments).
Output Mode Selection and Power Controls
Power Up/Down - These buttons adjust the power setting; the yellow arrow buttons for the
PlasmaKinetic (PK), SuperPulse (SP) and ThermoKinetic (T and TS) outputs and the blue
arrow buttons for the Vapor Pulse Coagulation (VP) and Desiccate (DES) output. Press the
appropriate button once for a power increment or decrement. Holding down the button
accelerates the incrementing or decrementing.
NOTE
Power can only be adjusted once an instrument is properly connected to the
generator. When using Gyrus ACMI instruments default output power and power
range limiting is set appropriate to that instrument.
SuperPulse
Cut
SP3
SP2
SP1
Difficult high flow conditions and/or High impedance
Moderate flow conditions
Low flow conditions
Voltage increasing
PlasmaKinetic PK3
Cut
PK2
PK1
High impedance tissue (fatty, vascular tissue)
Medium impedance tissue
Low impedance tissue (thin tissue)
Voltage increasing
ThermoKinetic Cut
(T)
T2
T1
High impedance tissue (fatty, vascular tissue)
Low impedance tissue (thin tissue)
Voltage increasing
(TS)
TS1
TS2
Moderate tissue vascularity
Higher tissue vascularity
Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)
Part Number: 144020-LB
USER MANUAL
Hemostasis
decreasing
Page 4-3
GENERAL INFORMATION
When using a Gyrus ACMI instrument, the connected instrument is automatically sensed by
the generator and the default power for that instrument will be selected.
Page 20
SECTION 4
GENERAL INFORMATION
SECTION 4
Coagulation
DES
VP3
VP2
VP1
General purpose, Non tissue-specific desiccation
High impedance tissue (fatty, vascular tissue)
Medium impedance tissue
Low impedance tissue (thin tissue)
Voltage increasing
NOTE
Output mode selection can only be performed with an instrument and
connector cable attached to the generator. The range of modes available
will depend on the type of Gyrus ACMI PK instrument being used.
NOTE
If the Mode / Menu button is quickly pressed and released the generator
enters a menu based configuration state, pressing and holding the Mode /
Menu button at any time exits this state.
NOTE
The PK output is not available for some PK instruments. The lower left
hand portion of the display remains blank in this case.
GENERAL INFORMATION
Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)
Part Number: 144020-LB
USER MANUAL
Page 4-4
Page 21
SECTION 4
GENERAL INFORMATION
Mode Selection using Gyrus ACMI PK/SP Instruments - There are three
PlasmaKinetic Modes shown as PK1, PK2 and PK3, which produce a tissue effect
increasing from PK1 to PK3 (PK3 delivers power more effectively to higher impedance
tissue than PK1). Two of the ThermoKinetic outputs available, shown as T1 and T2,
continuously switch between a PlasmaKinetic and Desiccate output during activation.
These ThermoKinetic outputs will provide a greater degree of hemostasis during tissue
cutting compared to a PK setting.
Three VP mode levels and the desiccate (DES) are available.
For instruments that support the SuperPulse waveform the PK modes are replaced by SP
modes SP1, SP2, and SP3, producing an increasing tissue effect from SP1 to SP3. The
SuperPulse modes provide high-energy pulses promoting rapid generation of the plasma
corona around the active electrode. Once the plasma corona is established the output
reverts to a continuous wave. The SP equivalents of the T1 and T2 ThermoKinetic outputs,
TS1 and TS2 rely on selective modulation of the SP2 SuperPulse waveform, to provide a
higher crest factor and therefore increased hemostasis.
SECTION 4
VP1 is optimal for low impedance tissue, VP2 for intermediate impedance tissue and VP3
for higher impedance tissue or larger diameter instruments. The frequency of pulses in VP
mode will also vary depending on the type of instrument attached: generally, the larger the
tissue contact area, the slower the pulses. DES provides a conventional continuous bipolar
output.
The waveforms associated with the blue and yellow pedals can be individually assigned.
To change the waveform press the Mode / Menu button until the option to change the
waveform required is seen on the display (yellow pedal waveforms appear on the LHS and
blue pedal waveforms on the RHS).
TURis Mode for Olympus TURis Electrodes
The Gyrus ACMI SuperPulse System supports compatibility with the Olympus TURis
Resectoscopic System.
When the supplied TURis cable is connected, the generator will automatically provide the
default settings.
Modify the settings for the connected instrument to achieve the desired tissue effect.
TP Mode – Provides vaporisation/ cutting yellow pedal outputs for use with the
Olympus TURis Electrodes (TP3 setting is more aggressive than TP1)
Refer to the instructions for use supplied with the compatible TURis Electrode range and the
Olympus Resectoscope.
DES provides a Blue pedal coagulation output.
The outputs can be adjusted in the same manner as described in section 4B to suit
physician preferences.
Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)
Part Number: 144020-LB
USER MANUAL
Page 4-5
GENERAL INFORMATION
4C.
Page 22
SECTION 4
GENERAL INFORMATION
Using the UP/DOWN buttons as indicated on the screen, will cycle through the available
waveforms for the respective pedal (see Fig. 4.4 below).
When the desired mode is displayed a further press on the Mode / Menu button will
complete the selection
Select
Mode
SECTION 4
DES
Fig 4.4 Screen for coag waveform selection
Socket Selection
The generator permits two instruments to be fitted simultaneously, via the two 5-way
connectors.
GENERAL INFORMATION
Only one socket can deliver RF at any one time. When the generator is switched on from
the Standby state, it initially operates an automatic socket selection mechanism, and
assists primary connection by activating whichever socket first has an instrument attached.
The instrument connected to the active socket is indicated on the display. Thereafter socket
selection can only be altered manually, by pressing the black mode footswitch, ensuring
that the surgeon always has control over which instrument is activated.
Black Mode
Footswitch
Fig 4.5 Footswitch
Footswitch - Blue Pedal
The blue footswitch pedal is used to administer desiccate and VP output waveforms. The
output will be present while the footswitch is held down.
Footswitch – Yellow Pedal
The yellow footswitch pedal is used to administer ThermoKinetic and PK/SP (cut)
waveforms. The output will be present while the footswitch is held down.
Footswitch – Black Mode Footswitch
The black mode footswitch enables a rapid change between instruments.
Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)
Part Number: 144020-LB
USER MANUAL
Page 4-6
Page 23
SECTION 4
GENERAL INFORMATION
Generator Switch On/Off
The mains power On/Off rocker switch is located on the top left of the rear panel (viewed
from front). The Generator is switched on by pressing the side marked l. The generator will
display the Serial number of the generator, then the internal tests are performed then the
green LED below the Mode / Menu button will come on continuously, and then flash after a
short time. The generator is then in Idle state.
The generator display will dim after a period of 30 minutes of not being used and will
automatically enter Standby state if it is not used for a period of four hours.
It is advisable to switch off the Generator whenever it is not in use for any extended period,
by using the rear panel switch. The side marked “0” should be pressed to do this.
If an instrument is present at switch on then the user has to accept the default powers, by
pressing the Mode / Menu button when prompted.
4D.
SuperPulse Generator Indicators, Set-up and Malfunction Displays
SECTION 4
To enable use of the generator the Standby / On button must be pressed and the generator
will then enter the idle state if no instrument is fitted or the Ready state if an instrument is
fitted.
Volume Adjustment - The activation tone volume can be adjusted between minimum and
maximum using the up control of the desiccate (blue) power control. Depress and release
the Mode / Menu button until the symbol “SELECT VOLUME” appears (Fig. 4.6). Press
and release the Mode / Menu button once more to accept the setting.
volume
10
1
Fig 4.6 Screen for Alarm volume selection
System Failure Displays
Non-critical (Soft) Faults
Shorting - For Gyrus ACMI Urology instruments, if a Generator “Output Shorted” message
occurs the power will be removed for 0.5 seconds and the activation tone will also be
terminated for this time. If the pedal is kept depressed, RF activation will resume. If three
short circuits occur in 2 seconds then RF activation is stopped until the pedal is released
and pressed again. Power levels will remain the same as those previously in use.
Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)
Part Number: 144020-LB
USER MANUAL
Page 4-7
GENERAL INFORMATION
Select
Page 24
SECTION 4
GENERAL INFORMATION
OUTPUT
SHORTED
RE-APPLY
PEDAL
SECTION 4
Fig 4.7 Screen for the selected SP electrode shorted
Storage at low temperatures – The generator will detect where the enclosure temperature
is below the specified minimum allowable for use, and will display a ‘WARMING UP”
message until an acceptable temperature is reached internally, whereupon normal
operation will resume. This condition is possible where the generator has been brought
directly into the operating room from a cold storage environment.
WARMING UP
GENERAL INFORMATION
Fig 4.8 Screen for an excessively cold condition
Foot pedals stuck on – The generator will detect where one or more the foot pedals
appears to be stuck on, and will wait until the condition disappears before resuming normal
behaviour. This condition can be inadvertently caused by inverting the footswitch or
standing on a pedal as the generator is switched on.
CHECK
IRRIGANT/CABLE
Fig 4.9 Saline Detection Mode in TURis Mode Only
If the SuperPulse Generator is activated when the electrode is not in saline or with only
one Resectoscopic cable connection present the above message will be displayed. No
RF output will occur.
Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)
Part Number: 144020-LB
USER MANUAL
Page 4-8
Page 25
SECTION 4
GENERAL INFORMATION
Non-critical (Recoverable) Faults
Fault - If a fault is detected during set-up or during use a fault code message is displayed
as indicated by the “Fault Code X00 REF XX” symbol on the front panel display (Fig 4.10
Screen for recoverable fault display). Refer to Section 9, Operating Room
Troubleshooting.
BUTTON
STUCK
SECTION 4
Fault code
400
Ref
15
Fig 4.10 Screen for recoverable fault display
Critical (Non-recoverable) Errors
INTERNAL
FAILURE
Error code
200 Ref 25
Fig 4.11 Screen for critical error display
SuperPulse Generator Connectors and Sockets
The PK Three Way connector cable is connected to the generator through either of the two
PK connector cable socket on the front panel of the generator (figure 4.1).
The SuperPulse function is only available through the right hand socket and the SuperPulse
instruments must therefore be connected to this socket. Olympus TURis mode is only
available from this socket.
The mains power cord; footswitch cable and protective earth cable are connected to the
generator through fittings on the rear panel.
Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)
Part Number: 144020-LB
USER MANUAL
Page 4-9
GENERAL INFORMATION
Red Warning Symbol - Except during the self-test routine and a non-critical failure,
illumination of the red warning symbol on the front panel when accompanied by the
“ERROR XXX REF XX” symbol (Fig 4.11 Screen for critical error display) on the front
panel display indicates a critical failure. In the case of a critical failure, DO NOT ATTEMPT
TO USE THE UNIT. Please refer to Section 11 for information.
Page 26
SECTION 4
4E.
GENERAL INFORMATION
CHANGING THE DISPLAY LANGUAGE
From the SuperPulse generator idle state (with the VFD screen showing the “Connect PK
Cable” or “X Way Cable Attached Insert Device” message), press and hold for 3 seconds
the Mode / Menu button on the SuperPulse front panel.
The SuperPulse generator VFD screen will show the “Display Intensity” message, press
and release the Mode / Menu button twice so the following screen is displayed.
Select Language
SECTION 4
English
Fig 4.12
Use the right hand arrow buttons to change the language as required. Press and hold the
Mode / Menu button down to return to the previous state.
GENERAL INFORMATION
Once the language has been changed from the factory default of English, the SuperPulse
will continue to use the selected language for all instructions, performance information
and error messages on the generator VFD display.
Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)
Part Number: 144020-LB
USER MANUAL
Page 4-10