gyrus_acmi_g400_workstation_user_manual_issue_hc_no.pdf
Page 1
TITLE: Gyrus ACMI G400 Workstation USER MANUAL
PART NO./ISSUE:
177012-HC
GYRUS MEDICAL LIMITED
Fortran Road
St. Mellons
Cardiff CF3 0LT
UK
Tel : (029) 2077 6300
Fax : (029) 2077 6301
TITLE:
Gyrus ACMI G400 Workstation
USER MANUAL
PART NO./ISSUE:
177012-HC
PAPER:
GRADE:
SIZE:
COLOUR:
TEXT:
COLOUR:
BLACK
4 HOLE DRILLED (LEFT HAND SIDE)
TOTAL PAGES:
40 DOUBLE SIDED PAGES
PAGE:
Title Page
Table of Contents
1-1 & 1-2
1-3 & 1-4
1-5 & 1-6
2-1 & 2-2
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2-7
3-1
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A4
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APPROVALS:
ECO:
8696
8863
8930
8938
9046
ISSUE:
A
B
C
D
E
100002
F
102758
G
100606
H
AMENDMENT:
First Release
Various changes to sections 2,4,6,13 due to software upgrade version 1.03.
UL page added
Page 10-1 nominal voltage changed from 220-230 volts to 230 volts
Page 1-5 new ref to Plasma Morcellator
Page 2-4 Caution statement updated.
Additional sections added 4E and 4F ref software version V1.04.
Minor text corrections to section 4.
Page 10-2 MR2 added to Max Voltage. Page 10-7 new MR2 load curve added.
Page 12-1 WEEE and storage symbols/description added.
CE mark changed from 0123 to 0344, minor text changes throughout the manual for
consistency
Remove the option to not display the impedance baragraph, Change to the standby button
fuction & state. Display the generator serial number on start-up & addition of cutting
progress indicator setup
Replace Gyrus Medical Inc with Gyrus ACMI Inc; replace Maple Grove address with
Southborough address. Remove reference to customer service international (non USA)
and Winnersh address, replace manufacturer with EC REP symbol and add ACMI to
footers and throughout document were Gyrus is present. Warning added Ensure any
PREPARED:
B Punter
B Punter
B Punter
B Punter
B Punter
CHECKED:
D Newton
D Newton
A Ford
D Newton
AF
DATE:
10/11/05
02/05/06
18/07/06
01/08/06
08/11/06
-
-
-
M Matthews
-
09-JAN-2008
M Matthews
-
05-AUG-2008
monopolar dispersive electrodes are removed from the patient. Omni software added.
M Matthews
Page 1 of 2
Page 2
TITLE: Gyrus ACMI G400 Workstation USER MANUAL
PART NO./ISSUE:
177012-HC
104805
HA
Part number added to footer to be in line with QSP 4.6 & PlasmaKinetic® changed to M Matthews
PlasmaKinetic as requested by K.Jamen on legal review of CO-100606.
Images of generators changed to include the new Gyrus ACMI logo.
-
12-NOV-2008
111772
HB
G400 user manuals updated to reflect the requirements of QSP 9.4 & 4.6.
Updates include the following:Date of up issue added to front cover QSP 4.6 & Symbols updated
OSD text string from HDSWT STUCK! to HANDSWITCH STUCK, section 11 pages
11-5 & 11-6 (22,23 & 24)
Page 1-6 G400 workstation cart No changed to 700000
Page 15-1 Trade mark statement updated
Text amended on 1A & 1B. Text amended due to minor
clarification to background text sections – no change to use instructions,
contra-indications or warnings, no impact on safety or efficacy.
All references to Trissector and PlasmaSEAL removed. PlasmaSORD added.
Formatting throughout document has been aligned
M Matthews
-
09 SEP-2010
114879
HC
The changes now are:
1) [POST check] has been added to fault code 400/12, 400/22, 400/23 and
400/24 description on pages 11-5 and 11-6.
2) Old fault Code 600/13 deleted and 600/14 renamed 600/13 (this was
previously an error since 600/14 shouldn’t have existed).
3) New Fault codes 600/14 and 600/15 have been added on page 11-6.
4) Fig. 4-2 to show the Omni default settings HC3 25 & VP3 100.
M Matthews
-
01-DEC-2010
M Matthews
Page 2 of 2
Page 3
G400 Workstation
USER MANUAL
Manufactured for:
Gyrus ACMI Inc
136 Turnpike Road
Southborough
MA 01772-2104
USA
Gyrus Medical Ltd
St Mellons
Cardiff
CF3 0LT
United Kingdom
0344
Customer Service USA:
Rx only
Customer Service: 1-888-524-7266
Technical Service: 1-800-621-3739
www.gyrusacmi.com
CAUTION: Federal Law (USA) restricts this device to sale by
or on the order of a Physician or Dentist.
Gyrus ACMI Part No: 177012-HC
2010-11
777000
Page 4
TABLE OF CONTENTS
SECTION
1
PART
1A
1B
1C
1D
1E
1F
2
2A
2B
2C
2D
2E
2F
2G
2H
3
3A
3B
3C
3D
3E
4
4A
4B
4C
4D
4E
4F
4G
5
5A
5B
6
6A
6B
6C
6D
6E
6F
7
8
8A
8B
8C
9
10
11
12
13
14
15
16
PAGE
INTRODUCTION
Overview of the G400 Workstation
Comparison with Conventional Electrosurgery
Indications for Use
Contraindications for Use
System Description
Instrument Description
PATIENT AND OPERATING ROOM SAFETY
General
Servicing
Equipment Disposal
Fire/Explosion
Before Surgery
During Surgery
After Surgery
EMC Classification
INSTALLATION
Responsibility of the Manufacturer
G400 Workstation Power Requirements
Grounding of the G400 Workstation
Routine Maintenance of the G400 Workstation
Medical Electrical Systems
GENERAL INFORMATION
Gyrus ACMI G400 Workstation Indicators
and Displays
Output Mode Selection and Power Controls
G400 Workstation Indicators, Set-Up
and Malfunction Displays
Video on Screen Display (OSD) Feature
Changing The Display Language
Enabling Additional Instruments via a PIN code
Cutting Progress Indicator Set Up.
BEFORE SURGERY
Power up the G400 Workstation
Attach Gyrus ACMI PC & PK Instrument to the G400 Workstation
DURING SURGERY
Recommendations During Surgery
PC/PK Default Settings
Activation: Output Selection and Audible Tones
Changing Output Mode and Power Setting During Surgery
Changing Instruments During Surgery
Changing Accessories Between Procedures
TECHNIQUES TO OPTIMIZE PERFORMANCE
AFTER SURGERY
Following Surgery
Cleaning the Footswitch
Cleaning the G400 Workstation
OPERATING ROOM TROUBLESHOOTING
PERFORMANCE SPECIFICATIONS
ERROR AND FAULT CODES
EXPLANATION OF SYMBOLS
PERIODIC EQUIPMENT SAFETY CHECKS
EMC TABLES
LIMITED WARRANTY
UL
Gyrus ACMI G400 Workstation
Part Number: 177012-HC
USER MANUAL
1-1
1-1
1-4
1-4
1-4
1-5
2-1
2-2
2-3
2-3
2-3
2-5
2-6
2-7
3-1
3-1
3-1
3-1
3-1
4-1
4-4
4-11
4-15
4-16
4-17
4-19
5-1
5-1
6-1
6-1
6-1
6-2
6-2
6-3
7-1
8-1
8-1
8-1
9-1
10-1
11-1
12-1
13-1
14-1
15-1
16-1
TABLE OF CONTENTS
Page 5
SECTION 1
INTRODUCTION
Gyrus Medical Ltd, Gyrus Medical Inc and Gyrus International Ltd are referred to as Gyrus ACMI in
this user manual.
This user’s manual will familiarize you with the controls and output functions available from your
G400 Workstation and instruct you on its proper use.
1A.
OVERVIEW OF THE G400 WORKSTATION
Bipolar electrosurgery is a familiar tool widely employed in surgery. Based on similar
principles, the Gyrus ACMI PlasmaKinetic technology combined with Gyrus ACMI PK
instruments provides effective coagulation and cutting of tissue.
Gyrus ACMI PlasmaCision technology combined with Gyrus ACMI PC instruments provides
simultaneous cutting and coagulation of tissue.
A key feature of the Gyrus ACMI G400 Workstation is the capability of the G400 Workstation
to identify the type of Gyrus instrument connected to it. The identification of the instrument
causes the G400 Workstation to operate in either the PlasmaKinetic (PK) mode or
PlasmaCision (PC) mode. This identification feature assigns default output designed to
produce the desired electrosurgical effect for that particular instrument. The user can change
this default to obtain a wider range of PlasmaKinetic (PK) or PlasmaCision (PC) outputs
from the device. Power and mode adjustments can be performed by the front panel buttons or
via the footswitch with the selected output on the user display.
By adjusting power and voltage two tissue effect modes can be produced.
In the cut mode, PlasmaKinetic (PK) RF energy is used to vaporize/transect soft tissue. PK
energy heats tissue cells quickly at a high temperature (in excess of 400F or 200C). The
steam created causes the cell to explode. With many cells exploding, the surgeon achieves a
cutting effect. With the PlasmaKinetic mode, an electrically charged field is created around
one pole of the PK instrument resulting in vaporization of tissue. This active pole provides
effective tissue cutting with a predetermined level of hemostasis.
In the coagulation mode, PlasmaKinetic (PK) RF energy provides rapid, predictable and
controlled elevations in tissue temperature to tissue located between the electrodes of a Gyrus
ACMI instrument. This mode can be used to coagulate tissue, seal vessels and provide
hemostasis. Coagulation allows protein to reorganize and form a coagulum without rapid
desiccation.
Instruments are designed to provide vaporization/transection and/or coagulation/sealing of
tissue, using the yellow and blue pedals respectively of the footswitch.
The Gyrus ACMI G400 Workstation is intended to be used only with designated Gyrus ACMI
instruments, cables, footswitch and accessories.
To avoid incompatibility and unsafe operation only Gyrus ACMI cables and accessories should
be used.
The G400 Workstation uses instrument specific limits on the system output voltage and power.
Gyrus ACMI accessories are rated for at least the maximum peak output voltage of the
system.
1B.
COMPARISON WITH CONVENTIONAL ELECTROSURGERY
Conventional bipolar electrosurgery outputs are rarely optimized to the performance
characteristics of specific instruments. This can reduce the speed of clinical effect, increase
the thermal margin around the application site and result in tissue sticking to the instrument.
The following describes the features of the PlasmaKinetic G400 Workstation when used with
Gyrus ACMI PK & PlasmaCision instruments that distinguishes it from conventional bipolar
generators.
Gyrus ACMI G400 Workstation
Part Number: 177012-HC
USER MANUAL
Page 1-1
Page 6
SECTION 1
INTRODUCTION
PlasmaKinetic - A Comparison with Conventional Electrosurgery
Conventional bipolar electrosurgery requires that both “poles” of the instrument contact tissue
to complete the electrical circuit and produce a tissue effect. The fact that the two poles of
the circuit are spaced very closely together means that current flows only through the tissue
to be affected. This localized current flow preserves the recognized safety features of
conventional bipolar electrosurgery.
The intense concentration of electrosurgical energy delivered by the technology offers
instantaneous vaporization of tissue. This same effect can be achieved with monopolar
electrosurgery but at very high power levels which have recognized complications and safety
concerns. Furthermore, the deep tissue heating of monopolar arrangements, which occurs
during tissue vaporization, causes a progressive deterioration in efficiency over the period of
the procedure. The G400 Workstation’s PlasmaCision and PlasmaKinetic technologies
overcome this problem and provide a predictable repeatable tissue effect throughout the
procedure. In order for the system to produce this effect, the G400 Workstation has integral
feedback systems.
The size of the working tip geometry determines the amount of power needed to ensure
optimal performance. To simplify set-up, the G400 Workstation will automatically select a
default power and mode setting according to the instrument type. The selected output will be
shown on the user display screen.
Instruments are supplied in a sterile, single use format and connect to the G400 Workstation
via their integral connection cable. Activation of the electrosurgical current occurs by means
of a footswitch, attached via the back panel. Alternatively certain instruments have hand
switching capability. The instrument is connected to the G400 Workstation and recognized by
the automatic identification system. The G400 Workstation will produce an activation tone
whenever electrosurgical energy is being output. Diagnostic circuits within the G400
Workstation continuously monitor system performance. Any detected faults are indicated on
the user display screen in conjunction with the illumination of the front panel warning
indicator. Activation “under fault” conditions is inhibited by safety circuitry.
Four forms of energy output are available with the G400:
•
Vapor Pulse Coagulation (VPC) (Blue Pedal)
VPC produces controlled coagulation or sealing of vascular pedicles using vaporfocused pulses of energy. VPC has been specifically tailored for delivery through
certain Gyrus ACMI PK and PlasmaCision Instruments. Once tissue to be coagulated
is grasped in a PK or PC Instrument, the tissue is treated using the pulses of
PlasmaKinetic energy compared to the continuous output employed in conventional
bipolar generators. This feature provides controlled and repeatable outcomes under a
variety of surgical situations.
•
Coagulation - DES/100% COAG (Blue Pedal)
DES is a continuous coagulation output (conventional bipolar electrosurgery) available
for use on PlasmaKinetic and PlasmaCision instruments. The output energy is applied
across the two coagulation poles of PlasmaCision instruments and the two poles of
PlasmaKinetic instruments.
•
PlasmaKinetic Tissue Cutting (PK) (Yellow Pedal)
In the PK output mode, the RF energy is used to create an electrical arc into the tissue
located between the electrodes of a Gyrus ACMI PK instrument. This enables tissue
cutting through vaporization and a level of hemostasis dependent on the selected PK
output level. This mode utilizes the conductive properties of the tissue itself during
application of the RF energy.
Gyrus ACMI G400 Workstation
Part Number: 177012-HC
USER MANUAL
Page 1-2
Page 7
SECTION 1
•
INTRODUCTION
PlasmaBlend Output – Simultaneous Cutting and Coagulation (Yellow Pedal)
PlasmaCision provides an enhancement to the PlasmaKinetic technology by
combining simultaneous cutting and coagulation of tissue during RF activation. It
utilizes three ‘poles’ instead of the traditional two ‘poles’ used in conventional bipolar
electrosurgery.
The output cutting and coagulation waveforms are alternately switched between the
instrument’s three ‘poles’ in order to achieve a sequential cutting and coagulation
function available from the yellow pedal.
NOTE
This is only available on particular instruments such as the Plasma J–Hook
and the PKS Omni instruments via the dedicated PlasmaBlend outputs for
these instruments (HC1, HC2 and JH waveforms). See instrument
instructions for use for further details.
Gyrus ACMI G400 Workstation
Part Number: 177012-HC
USER MANUAL
Page 1-3
Page 8
SECTION 1
INTRODUCTION
1 C. INDICATION FOR USE
The G400 Workstation is a general surgical electrosurgical generator device intended for use
with Gyrus ACMI instruments used in open and laparoscopic surgical procedures involving
the cutting and coagulation/sealing of soft tissue. This electrosurgical system 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:
Circumcision procedures
Electrosurgery should not be used for circumcision.
Patients with Pacemakers / Active Implants
Use with caution in the presence of internal or external pacemakers or other active implants.
Interference from an electrosurgical current can cause a pacemaker/active implants to
change their therapy delivery or can block the devices function entirely. For further
information, consult the pacemaker/active implants manufacturer or the hospital Cardiology
Department.
Clinical Judgment
The use of the G400 Workstation is contraindicated when in the judgment of the physician;
electrosurgical procedures would be contrary to the best interest of the patient.
1E.
SYSTEM DESCRIPTION
The G400 Workstation (figure 1.1) is designed for use in surgery for the cutting and
coagulation/sealing of soft tissue.
A typical system setup comprises the following items:
•
•
•
•
•
G400 Workstation
Footswitch
Gyrus ACMI PK or PC surgical instrument(s) – not shown.
Video connection kit – not shown.
Dual Footswitch connector cable – not shown.
Fig 1.1 Gyrus ACMI G400 Workstation and Footswitch
Gyrus ACMI G400 Workstation
Part Number: 177012-HC
USER MANUAL
Page 1-4
Page 9
SECTION 1
1F.
INTRODUCTION
INSTRUMENT DESCRIPTION
The instruments below are designed and rated to be used with the G400 Workstation. For
convenience and to improve safety during use, all the dedicated instruments have an internal
classification code, which is recognized by the G400 Workstation when the instrument is
attached. Default settings and power set adjustment limits are then set appropriately for that
particular instrument. Instruments are supplied sterile and are single use only.
Compatible Instrument types (in model # order)
Model #
Description
Product Group: PKS MOLly® Forceps
910000PK
33 cm 3mm PKS MOLly Forceps, w/ Cord
910005PK
33 cm 5mm PKS MOLly Forceps, w/ Cord
910010PK
45 cm 5mm PKS MOLly Forceps, w/ Cord
Product Group: PKS SEAL™ Open Forceps – Curved
915000PK
25 cm PKS SEAL Open Forceps, Curved Jaw, w/ Cord
Product Group: PKS SEAL™ Open Forceps – Straight
915005PK
25 cm PKS SEAL Open Forceps, Straight Jaw, w/ Cord
Product Group: PKS SEAL™ Open Forceps – Angled
915010PK
25 cm PKS SEAL Open Forceps, Angled Jaw, w/ Cord
Product Group: PKS 5mm Cutting Forceps
920000PK
24 cm 5mm PKS Cutting Forceps, w/ Cord
920005PK
33 cm 5mm PKS Cutting Forceps, w/ Cord
920010PK
45 cm 5mm PKS Cutting Forceps, w/ Cord
Product Group: PKS 10mm Cutting Forceps
921015PK
15 cm 10mm PKS Cutting Forceps, w/ Cord
921020PK
33 cm 10mm PKS Cutting Forceps, w/ Cord
Product Group: PKS Omni™
970000PC
15 cm PKS Omni
970005PC
24 cm PKS Omni
970010PC
33 cm PKS Omni
970015PC
45 cm PKS Omni
Product Group: PKS LYONS™ Dissecting Forceps
942000PK
24 cm PKS LYONS Dissecting Forceps, w/ Cord
942005PK
33 cm PKS LYONS Dissecting Forceps, w/ Cord
942010PK
45 cm PKS LYONS Dissecting Forceps, w/ Cord
Product Group: PKS Needle Instrument
950000PK
33 cm PKS Needle Instrument, w/ Cord
Product Group: PKS PlasmaSpatula
952000PK
24 cm PKS PlasmaSpatula, w/ Cord
952005PK
33 cm PKS PlasmaSpatula, w/ Cord
952010PK
45 cm PKS PlasmaSpatula, w/ Cord
Product Group: PKS L-Hook
954000PK
33 cm PKS L-Hook, w/ Cord
954005PK
45 cm PKS L-Hook, w/ Cord
Product Group: PKS Plasma J-Hook™
956000PC
15 cm PKS Plasma J-Hook, w/ Cord
956005PC
24cm PKS Plasma J-Hook, w/ Cord
956010PC
33 cm PKS Plasma J-Hook, w/ Cord
956015PC
45 cm PKS Plasma J-Hook, w/ Cord
Product Group: PKS LP Scissors
960000PK
33 cm PKS LP Scissors, w/ Cord
960005PK
45 cm PKS LP Scissors, w/ Cord
Product Group: RF Morcellator
962000PK
PKS PlasmaSORD Morcellator
36309PK
2x1 Accessory Grasper
Gyrus ACMI G400 Workstation
Part Number: 177012-HC
USER MANUAL
Page 1-5
Page 10
SECTION 1
INTRODUCTION
Workstation Accessories
Model #
Description
Product Group: G400 Workstations and Accessories
777000
744010
IDC-0130
560085-002
700000
710003
G400 Workstation w/ 9-Pin Inputs
G400 Footswitch (also compatible with SuperPulse Gen.)
G400 Video Cable Accessory
G400 Workstation Power Cord-US
G400 Workstation Cart
Dual Footswitch Connector Cable
NOTE
It is not possible to insert and use multiple instruments from the same instrument product
group on the G400 Workstation. i.e. 2 PKS PlasmaSpatulas
The G400 Workstation will display an “Invalid Instrument” message on its display if two
instruments from the same product group are inserted.
Gyrus ACMI G400 Workstation
Part Number: 177012-HC
USER MANUAL
Page 1-6
Page 11
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, understood, and followed.
Before starting any surgical procedure, the physician should be familiar with the medical literature,
complications and hazards of electrosurgery in that procedure.
2A.
GENERAL
WARNING Hazardous Electrical Output: This equipment is for use only by qualified
personnel.
WARNING Electrical shock hazard: The G400 Workstation is not user-serviceable. Do not
attempt to remove the cover of the G400 Workstation or perform servicing on its
parts. Refer servicing to qualified Gyrus ACMI personnel only.
WARNING Only use normal saline for irrigation.
WARNING Do not use monopolar generator/accessories simultaneously with the G400
Workstation. Activation of monopolar generator/accessories may cause
interference with the G400 Workstation resulting in user message changes on
the G400 Workstation display, or video output.
WARNING Ensure any monopolar dispersive electrodes are removed from the patient.
WARNING Before proceeding with surgery, confirm proper power settings are displayed on
the G400 Workstation. Ensure the appropriate output setting is enabled for the
desired surgical outcome. Ensure any monopolar earth pads are removed from
the patient.
WARNING Direct contact between activated monopolar accessories and G400 Workstation
connected accessories could damage the G400 Workstation. If such damage is
suspected, the G400 Workstation should be returned to Gyrus ACMI for
inspection.
WARNING Use with caution in the presence of internal or external pacemakers or other
active implants. 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 the
appropriate hospital Cardiology department.
WARNING Failure of high frequency surgical equipment may result in an unintended
increase in output power.
WARNING Do not use electrosurgical equipment unless properly trained in its use in the
specific procedure intended.
WARNING The G400 Workstation system has not been cleared for tubal sterilization. Do not
use this system for female sterilization procedures.
WARNING When high frequency (HF) surgical equipment and physiological monitoring
equipment are used simultaneously on the same patient, any monitoring
instruments should be placed as far as possible from the surgical instruments.
Needle Monitoring Instruments are not recommended.
In all cases, monitoring systems incorporating high frequency current limiting
devices are recommended, during electrosurgical procedures.
Gyrus ACMI G400 Workstation
Part Number: 177012-HC
USER MANUAL
Page 2-1
Page 12
SECTION 2
PATIENT AND OPERATING ROOM SAFETY
WARNING Instruments 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 instrument site,
place the instrument and/or probe as far away as possible from the
electrosurgical site.
WARNING Do not activate instruments while in contact with other instruments as
unintended tissue effect may occur.
WARNING Do not connect non-Gyrus ACMI instruments, footswitches or accessories to the
G400 Workstation.
2B.
CAUTION
If two instruments are connected to the G400 Workstation, ensure the
appropriate instrument is selected prior to activation.
Activation of the
unintended instruments could cause unintentional tissue effect.
CAUTION
Do not activate the G400 Workstation in an open circuit condition. To reduce
the risk of unintended effects, activate the G400 Workstation only when the
active instrument is near or touching the target tissue.
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 G400
Workstation accessories before use. This device is an integral system; only use
Gyrus ACMI approved accessories with the Gyrus ACMI G400 Workstation.
CAUTION
The instrument 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 G400 Workstation 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.
CAUTION
The G400 Workstation is not designed to be used or operated under dust or
sterile covers.
SERVICING
CAUTION
Electrical Shock Hazard: Do not tamper with the G400 Workstation housing or
attempt to remove the control panel. Refer to authorized personnel for service.
NOTE
1.
2.
There are no user serviceable parts within the product.
For maintenance of the G400 Workstation, refer to the recommended
periodic equipment safety checks in Section 13.
Gyrus ACMI G400 Workstation
Part Number: 177012-HC
USER MANUAL
Page 2-2
Page 13
SECTION 2
PATIENT AND OPERATING ROOM SAFETY
2C. EQUIPMENT DISPOSALS
2D.
CAUTION
The G400 Workstation 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.
FIRE/EXPLOSION
DANGER
Explosion Hazard: Do not use in the presence of flammable anesthetics.
WARNING Non-flammable agents should be used for cleaning and disinfecting where
possible.
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 cleaned 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 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.
2E.
BEFORE SURGERY
Instrument and Accessories
WARNING Electric Shock Hazard: Do not connect wet accessories to the G400
Workstation.
WARNING Electric Shock Hazard: Ensure that all accessories are correctly connected and
that no metal is exposed.
Gyrus ACMI G400 Workstation
Part Number: 177012-HC
USER MANUAL
Page 2-3
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SECTION 2
PATIENT AND OPERATING ROOM SAFETY
WARNING Do not attempt to re-use instruments labeled for Single Use Only. Heat or
chemical sterilization may render the instrument mechanically or electrically
unsafe.
WARNING The instruments for use with this workstation are single use only. They have not
been designed to be re-used or re-sterilized. Reprocessing may lead to changes
in material characteristics such as metallic corrosion and dulled edges, ceramic
and plastic deformation or splitting which may impact the strength of the device
and compromise device performance. Reprocessing of single use devices can
also cause cross-contamination leading to patient infection. These risks may
potentially affect patient safety.
CAUTION
Read the instructions, warnings and cautions provided with the Gyrus ACMI
instruments before using.
CAUTION
Instruments labeled as 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 instrument.
CAUTION
Always inspect the system accessories for damage prior to use. In particular,
check the cables of any re-usable accessory e.g. footswitch for possible
insulation damage.
CAUTION
Use only Gyrus ACMI approved instruments supplied for use with this product.
Product damage or accessory failure may otherwise result during use.
G400 Workstation
WARNING No equipment is to be connected to the rear panel digital interface during
surgical use. This interface is provided for use by trained personnel only.
WARNING Electric Shock Hazard. Connect the G400 Workstation power cord to a properly
grounded receptacle. Do not use power plug adapters.
WARNING Fire Hazard. Do not use extension cords.
WARNING In the unlikely event the video signal from the G400 Workstation fails, the
incoming camera video signal may not be present on the monitor.
This situation can be redeemed by either directly connecting the camera signal
to the monitor or deselecting the video output option on the G400 Workstation
(see video on screen display feature).
CAUTION
Provide as much distance as possible between the G400 Workstation and other
electronic equipment (such as monitors) as an activated G400 Workstation may
cause interference with them.
CAUTION
Non-function of the G400 Workstation may cause interruption of surgery. Ensure
that all installation procedures are followed and all connectors are correctly
inserted before use. A backup system / method should be made available for
use.
CAUTION
Do not stack equipment on top of the G400 Workstation or place the G400
Workstation 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.
Gyrus ACMI G400 Workstation
Part Number: 177012-HC
USER MANUAL
Page 2-4
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SECTION 2
CAUTION
2F.
PATIENT AND OPERATING ROOM SAFETY
Regularly inspect the cables of all accessories for possible damage to the
insulation prior to use.
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. Localized heating of the instrument and the
adjacent metal object may result in product damage, inadvertent injury or lack of
desired tissue effect.
WARNING The patient should not be allowed to come into direct contact with grounded
metal objects (e.g., surgical table frame, instrument table, etc.), or which have
an appreciable capacitance to earth. If this is not possible, use extreme caution
to maximize patient safety. The use of antistatic sheeting is recommended for
this purpose
WARNING If the electrosurgical effect is not as expected do not continue to use the G400
Workstation or Gyrus ACMI instruments
G400 Workstation Power Settings
WARNING Do not simultaneously activate the G400 Workstation while 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.
WARNING Always check that the automatic default settings shown on the display match the
intended settings.
CAUTION
Upon reconnection of an instrument to the electrosurgical G400 Workstation, or
after navigation using the Mode / Menu button, the power settings for cutting and
coagulation may be changed from previously selected values.
WARNING Confirm proper power settings are displayed on the G400 Workstation 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.
CAUTION
Failure of the HF SURGICAL EQUIPMENT could result in an unintended
increase or decrease in output power, change in output waveform
characteristics or absence of electrosurgical output.
CAUTION
Should a power supply interruption occur, with the instrument connected, the
G400 Workstation will prompt the user to confirm the selection of the default
settings when power is re-established.
Instrument Accessories
WARNING Ensure the tip of the instrument is visible before activation.
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. The instrument tip may remain hot
enough to cause burns after the electrosurgical current is deactivated. Do not
let one instrument come into contact with another if two or more are being used
simultaneously.
Gyrus ACMI G400 Workstation
Part Number: 177012-HC
USER MANUAL
Page 2-5
Page 16
SECTION 2
PATIENT AND OPERATING ROOM SAFETY
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 When using multiple instruments in a procedure, always ensure the G400
Workstation has accepted the newly inserted instrument by checking the G400
Workstation display screen prior to activation.
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.
WARNING Localized 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
CAUTION
Proper use of the system relies on tissue contact with the active and return tips
of the instrument. Read all accompanying instructions provided with each Gyrus
ACMI PK or PC instrument to ensure proper use and desired results.
CAUTION
Check all Gyrus ACMI PK or PC instrument accessories for possible damage to
the insulation prior to use.
Laparoscopic Procedures
WARNING If visualization becomes impaired during endoscopy be particularly alert to these
potential hazards:
CAUTION
2G.
Ensure the tip of the instrument is visible before and during activation.
Inadvertent activation or movement of activated instruments outside of the
field of vision may result in injury to the patient.
Carefully insert and withdraw instruments from cannulas/trocars to avoid
the possibility of damage to the devices and/or injury to the patient.
The instrument tip may remain hot enough to cause burns after the
electrosurgical current is deactivated.
Tissue effects may vary in presence of CO2
AFTER SURGERY
WARNING Electric Shock Hazard. Always unplug the G400 Workstation before cleaning.
CAUTION Do not reuse or resterilize accessories labeled “disposable” or “single use only.”
Gyrus ACMI G400 Workstation
Part Number: 177012-HC
USER MANUAL
Page 2-6
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SECTION 2
2H.
PATIENT AND OPERATING ROOM SAFETY
EMC CLASSIFICATION
The G400 Workstation 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 G400 Workstation should not be used adjacent to or stacked with other electrical
equipment. If adjacent or stacked use is necessary both the G400 Workstation and other
equipment should be observed to verify normal operation in the configuration in which it
will be used.
•
The EMC classification of the G400 Workstation system (class A) is suitable for use on
dedicated electrical supply systems not connected to the public electrical network. The
system is designed for hospital use.
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.
•
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 (Refer to section 1E).
•
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 G400
Workstation. Activation of a monopolar generator/accessories may cause interference
with the G400 Workstation resulting in user message changes on the display. Before
proceeding with surgery, confirm proper power settings are displayed on the G400
Workstation. Ensure the appropriate output setting is enabled for the desired surgical
outcome.
•
Provide as much separation as possible between the G400 Workstation and other
electronic equipment (such as monitors). When activating the G400 Workstation,
unintended electromagnetic coupling may cause interference with the other equipment.
•
Should any unintentional effects appear with other equipment when using the G400
Workstation, repositioning the G400 Workstation, the connecting leads or other equipment
may alleviate the problem. It may also help to use different mains supply sockets for any
affected equipment
Gyrus ACMI G400 Workstation
Part Number: 177012-HC
USER MANUAL
Page 2-7
Page 18
SECTION 3
INSTALLATION
The G400 Workstation described in this manual, in conjunction with the Gyrus ACMI PK and
PlasmaCision Instruments, is designed to provide advanced electrosurgical effects during open and
laparoscopic surgery.
3A.
RESPONSIBILITY OF THE MANUFACTURER
The manufacturer is responsible for safety, reliability and performance of the equipment only
if:
Installation procedures in this manual are followed.
Assembly operations, extensions, re-adjustments, modifications or repairs are carried out
by persons authorized 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 and the Instructions For Use
that accompany all system accessories and any additional information contained on the
instrument package labeling.
3B.
G400 WORKSTATION POWER REQUIREMENTS
Please refer to section 10-1 for full voltage details.
Check the G400 Workstation 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 adaptor. When disconnecting from the
mains socket or from the G400 Workstation, cords should always be grasped by the plug. Do
not pull on the cord itself.
3C.
GROUNDING OF THE G400 WORKSTATION
To ensure user safety, the G400 Workstation must be properly grounded through the inlet
plug and power cord. Use only hospital grade power cords.
IMPORTANT
3D.
Ensure that the electrical installation of the relevant room complies with
local codes and regulatory requirements.
ROUTINE MAINTENANCE OF THE G400 WORKSTATION
It is recommended that the G400 Workstation be inspected by qualified service personnel in
accordance with Section 13, Periodic Equipment Safety Checks.
3E.
MEDICAL ELECTRICAL SYSTEMS
When the G400 Workstation forms part of a medical electrical system (as defined in EN
60601-1 2.201) or is used with an endoscope that is compliant with EN 60601 2-18 the
following applies:
The G400 Workstation is to be placed outside the patient environment.
The G400 video kit cabling is to be placed outside the sterile field.
The Gyrus ACMI footswitch accessory is to be placed outside the sterile field.
The Gyrus ACMI instruments intended for use with the G400 Workstation are suitable for
use inside the patient environment.
WARNING Additional multiple portable socket outlets or extension cords shall NOT be
connected to the system
WARNING . Any multiple portable socket outlets shall not be placed on the floor.
Gyrus ACMI G400 Workstation
Part Number: 177012-HC
USER MANUAL
Page 3-1
Page 19
SECTION 4
4A.
GENERAL INFORMATION
GYRUS ACMI G400 WORKSTATION INDICATORS AND DISPLAYS
Display Sceen
Red warning
lamp
Attach Instrument
Standby/On
Switch
PlasmaCision/PlasmaKinetic
Up/Down
(Cutting parameter
adjustment)
Standby / On
indicator
Mode /
Menu
button
Vapor Pulse and Des
Up/Down
(Coagulation parameter
adjustment)
Instrument & Connector
Cable sockets
Fig 4.1
Control Panel: Standby/On, Up, Down Arrows and Mode / Menu Buttons
Standby / On
The Standby/On button switches the G400 Workstation back and forth between the
Standby and Idle / Ready states. The green indicator will change from flashing to
continuous when the equipment state changes from Standby to Idle / Ready by pressing
the button. To place the generator into standby press the standby button. When prompted
press the button again, this confirms entry into Standby.
Following an error condition the G400 Workstation may be reset by pressing the
Standby/On button twice.
Up/Down Arrows
Depressing the up or down arrow button 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 front panel button provides access into the waveform selection and setup menus.
Repeated short presses will give access to the frequently used functions, listed below:
PlasmaCision, PlasmaBlend ratio adjustment
Cut waveform selection
Coagulation waveform selection
Volume
Gyrus ACMI G400 Workstation
Part Number: 177012-HC
USER MANUAL
Dependent on instrument insertion
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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:
Display intensity
Key click on/off
Video OSD Select
Language selection
Cutting Progress Indicator Set up
Enter PIN Code
NOTE
If there is no user activity for a short period, the G400 Workstation will exit the
menu and return to the previous state. Entry back to the previous state is also
possible by a long press of the button.
Output Displays for PlasmaCision (PC) Instruments with PlasmaBlend output
The display is split into a number of sections. The upper portion of the display shows the
type of instrument active, that is the instrument that will provide an output when the yellow
cut or blue coag pedal is pressed (see Fig 4.2 below)
The lower half of the display indicates the output waveform type and power level selected.
The lower left section shows the (cut) waveform selection for yellow pedal activation (in this
case) HC2 and the power level (50). The specific settings are dependent on the type of
instrument attached.
The right portion displays the waveform selection for blue pedal activation, (in this case
VP3) and the power level (50).
The appropriate display will flash and an audible alarm will sound when an output is
activated.
PlasmaBlend
Waveform
PKS Omni
HC3
25
VP3
100
Coagulation
Output
Waveform
Blue Pedal
Coagulation
Power
Yellow Pedal
PlasmaBlend
Power
Fig 4.2
Gyrus ACMI G400 Workstation
Part Number: 177012-HC
USER MANUAL
Page 4-2
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SECTION 4
GENERAL INFORMATION
Instrument Tip Cleanliness
The G400 Workstation can detect an excess build up of debris on the tip of certain
instruments e.g. the Plasma J-Hook. This is indicated to the user via the following screen:
RF Off
Please Clean Tip
Fig 4.3
Follow the cleaning recommendations in the instrument instructions for use to remove the
debris from the instrument.
Output Displays for PK Instruments
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
and power selected.
The left lower portion displays PlasmaKinetic (PK) mode selection PK1, PK2, PK3, MR2,
and ThermoKinetic mode selection T1 or T2, with the default power setting from 10 to 200
dependent on the type of Gyrus ACMI PK Instrument attached.
The right portion displays Vapor Pulse Coagulation (VPC) mode selection VP1, VP2, VP3
and standard desiccate (DES), with the default power setting from 10 to 120 dependent on
the type of Gyrus ACMI PK instrument attached.
The appropriate power level display will flash and an audible tone will sound when an
output is activated.
Needle
PK3
40
DES
20
Fig 4.4 Screen for Needle instrument selected.
NOTE
The PK CUT output is not available for some PK instruments. The lower left
hand portion of the display remains blank in this case.
Gyrus ACMI G400 Workstation
Part Number: 177012-HC
USER MANUAL
Page 4-3
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SECTION 4
4B.
GENERAL INFORMATION
OUTPUT MODE SELECTION AND POWER CONTROLS
The G400 Workstation allows the surgeon to adjust the various power and waveforms from
the default setting for the selected instrument
Power Up/Down - These buttons adjust the power setting; the yellow arrow buttons for the
PlasmaKinetic (PK), PlasmaCision (PC) and ThermoKinetic (T) outputs, and the blue arrow
buttons for the Vapor Pulse Coagulation (VPC) and Desiccate (DES)/100% COAG output.
Press the appropriate button once for a power increment or decrement. Holding down the
button accelerates the rate of change of setting.
NOTE
Power can only be adjusted once an instrument is properly connected to the
G400 Workstation. The default output power and power range limiting is set
according to the instrument type.
The following output modes are available with the G400 Workstation
PlasmaBlend Output
The PlasmaBlend technology offers a switched cut and coagulation output via the yellow
pedal.
This allows the cut and coagulation waveforms to be individually applied to particular
instrument parts to obtain haemostatic cutting of tissue.
The surgeon can adjust the ratio of cut to coagulation independently of the usual power
adjustment. The PlasmaBlend parameters can be selected from a range of presets and
adjustable to suite particular tissue conditions.
Increased CUT% leads to a more aggressive cut and reduced hemostasis.
Increased COAG% leads to increased hemostasis and a less aggressive cut.
There are presets specific to each PlasmaCision instrument.
Gyrus ACMI G400 Workstation
Part Number: 177012-HC
USER MANUAL
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GENERAL INFORMATION
PlasmaBlend Output – cont’d
JH Preset options for Instrument - Plasma J-Hook
These presets consist of a various ratios of Cut/Coagulation in the form of a continuous
blended waveform.
JH5
95% cut 5% coag – most aggressive cutting effect with least haemostatic effect
JH4
80% cut 20% coag
JH3
50% cut 50% coag
JH2
20% cut 80% coag - Default setting providing a balance of cutting & coagulation.
JH1
5% cut 95% coag – least aggressive cutting effect with most haemostatic effect
In addition to the above presets, it is possible for the surgeon to adjust the individual JH
presets to have different ratios of cut percentage to coagulation percentages. If this occurs
the ratio is displayed with a suffix to indicate that it has been modified.
e.g. JH2x Modified JH2 setting as result of the user adjustment of blend ratio percent.
NOTE
The modified JH presets will be retained if the Plasma J-Hook is removed from
the G400 and then re-inserted into the same socket.
All modified JH presets will be lost and the G400 will return to factory defaults
when the G400 is switched off or the Plasma J-Hook is removed and a different
type of instrument inserted into the same socket.
Gyrus ACMI G400 Workstation
Part Number: 177012-HC
USER MANUAL
Page 4-5
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SECTION 4
GENERAL INFORMATION
Selection and Change of PlasmaBlend Preset Settings using Footswitch
The selected PlasmaCision instrument can be adjusted to use a different preset
PlasmaBlend setting by using the footswitch.
Firstly, in order to adjust the setting the Black Mode Footswitch should be held depressed
for a period of greater than one second.
Once in the adjustment state, the Yellow (cut) and Blue (coagulation) foot pedals do not
result in an electrosurgical output or audible tone. Instead, during the adjustment state the
yellow and blue foot pedals can be used to adjust the selected PlasmaBlend preset setting.
Initially, on entering the adjustment state the currently selected preset for the Cut output is
displayed on the left hand side of the G400 display.
Cut Output Adjustment
To adjust the Cut output, either press the:Yellow footpedal button to advance to a more aggressive preset
(i.e. higher preset number – e.g. HC2-JH5)
or the
Blue footpedal button to advance to a less aggressive preset
(i.e. lower preset number - e.g. HC1-JH1)
NOTE
Repeated individual depressions of either of the footpedals will cause the
settings to cycle around on the G400 display – e.g. JH1 through to JH5 and
back to JH1.
Coagulation Output Adjustment
To adjust the Coagulation output mode, press briefly the Black Mode Footswitch. The G400
will show the currently selected coagulation output on the right hand side of the display.
NOTE
Repeated individual depressions of either of the footpedals will cause the
available coagulation settings to cycle around on the G400 display.
Press either the Yellow or Blue Button to advance through the available coagulation output
types.
At any time the adjustment state can be exited by pressing and holding the Black Mode
Footswitch for greater than one second. This will return the G400 to its normal Ready state
where depressing either the Yellow and Blue footpedal will once again result in an
electrosurgical output.
Gyrus ACMI G400 Workstation
Part Number: 177012-HC
USER MANUAL
Page 4-6
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SECTION 4
GENERAL INFORMATION
PlasmaKinetic
There are three PlasmaKinetic Modes: PK1, PK2 and PK3 that produce a tissue effect
increasing from PK1 to PK3. Two ThermoKinetic outputs are also available, shown as T1
and T2, which continuously switch between a PlasmaKinetic and Desiccate output during
activation. A ThermoKinetic output will provide a greater degree of hemostasis during
tissue cutting compared to a PK setting.
PlasmaKinetic Cut
(Yellow pedal)
ThermoKinetic Cut
(Yellow pedal)
PK3
High impedance tissue (fatty, vascular tissue)
(most aggressive PK waveform)
PK2
Medium impedance tissue
PK1
Low impedance tissue (thin tissue)
(least aggressive PK waveform)
T2
High impedance tissue (fatty, vascular tissue)
(most aggressive T waveform)
T1
Low impedance tissue (thin tissue)
(least aggressive T waveform)
Coagulation
(Blue pedal)
DES / 100%COAG
General Purpose, Non tissue-specific desiccation
Vapor Pulse Coagulation
(Blue pedal)
VP3
High impedance tissue (fatty, vascular tissue)
(most aggressive VP waveform)
VP2
Medium impedance tissue
VP1
Low impedance tissue (thin tissue)
(least aggressive VP waveform)
NOTE
Output mode selection can only be performed with an instrument attached to
the G400 Workstation. The range of modes available will depend on the type
of Gyrus ACMI instrument being used.
NOTE
If the front panel Mode / Menu button is quickly pressed and released the
G400 Workstation enters a configuration state; pressing and holding the Mode
/ Menu button at any time exits this state.
Coagulation
DES/100% COAG provides a conventional continuous bipolar coagulation output.
Vapor Pulse Coagulation (VPC)
In VPC mode, the G400 Workstation produces discrete pulses of RF energy. The Gyrus
ACMI Vapor pulse mode provided is not adjustable.
The frequency of pulses in VPC mode will also vary depending on the type of instrument
attached: generally, the larger the tissue contact area, the slower the pulses.
Gyrus ACMI G400 Workstation
Part Number: 177012-HC
USER MANUAL
Page 4-7