Gyrus Acmi G400 User manual

TITLE: Gyrus ACMI G400 Workstation USER MANUAL
PART NO./ISSUE: 177012-HH
M Matthews Page 1 of 3
GYRUS MEDICAL LIMITED
Fortran Road
St. Mellons
Cardiff CF3 0LT
UK
Tel : [phone]
Fax : [phone]
TITLE: Gyrus ACMI G400 Workstation
USERMANUAL
PART NO./ISSUE: 177012-HH
PAPER: GRADE: 90g/m2
SIZE: A4
COLOUR: WHITE
TEXT: COLOUR: BLACK
(FRONT PAGE TO BE IN COLOUR ONLY)
4 HOLE DRILLED (LEFT HAND SIDE)
TOTAL PAGES: 43 DOUBLE SIDED PAGES
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APPROVALS:
ECO: ISSUE: AMENDMENT: PREPARED: CHECKED: DATE:
8696 A First Release B Punter D Newton 10/11/05
8863 B Various changes to sections 2,4,6,13 due to software upgrade version 1.03. B Punter D Newton 02/05/06
8930 C UL page added B Punter A Ford 18/07/06
8938 D Page 10-1 nominal voltage changed from 220-230 volts to 230 volts B Punter D Newton 01/08/06
9046 E 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.
B Punter AF 08/11/06
100002 F CE mark changed from 0123 to 0344, minor text changes throughout the manual for
consistency - - -
102758 G 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
M Matthews - 09-JAN-2008
100606 H 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
monopolar dispersive electrodes are removed from the patient. Omni software added.
M Matthews - 05-AUG-2008

TITLE: Gyrus ACMI G400 Workstation USER MANUAL
PART NO./ISSUE: 177012-HH
M Matthews Page 2 of 3
104805 HA Part number added to footer to be in line with QSP 4.6 & PlasmaKinetic® changed to
PlasmaKineticas requested by K.Jamen on legal review of CO-100606.
Images of generators changed to include the new Gyrus ACMI logo.
M Matthews - 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
117942 HD As a result of the introduction of a new instrument of the portfolio of device used on the G400
generator, the User Manual will require an update.
3 sections have been updated.
Device table.
Maximum voltage updated BiL1 and BiL2
Software description as follows:
PKSTM BiLLTM
The PKSTM BiLLTM has 2 available waveforms. Upon connections to the G400 generator the
BiL1 waveform will be default. BiL1 will provide optimum cut performance however BiL2 will
provide a slower cut performance. Selection of BiL2 can be accessed by pressing the Mode
button on the G400 then pressing the yellow arrows.
BiL1 has a fixed peak power of 200W and BIL2 has a fixed peak power of 100W. Peak voltage
for BiL1 and BiL2 is 434v (PK2).
· BiL1 – A pulsed cut output with 50% at PK2, 50% off, oscillates at 50 Hz.
· BiL2 – A blended output with 40% at PK2, 60% at DES, oscillates at 40Hz.
5) Note: The PKSTM BiLLTM is a ‘non grasping instrument.’ POWER LIMIT will be
displayed on the G400 generator when short is detected. Refer to section 10 –
Shorting.
M Matthews - 25-MAY-2011
118729 HE G400 manual update
Manual updated to include:-
• Front sheet formatted and updated to include image.
• Overview page added
• Page 1-2 four changed to five forms of energy output are available with the G400
• Added to page 1-3
THERMOKINETIC-T1/T2 (YELLOW PEDAL)
A blended waveform is also available on selected instruments that combined cutting
and Coagulation to provide a degree of hemostasis when cutting.
• Page 4-2 settings amended to match screen shots.
• Page 4-6 Coagulation Output Adjustment re worded
• Page 4-7 (VP1, VP2, VP3) added
• Page 4-9 certain Gyrus ACMI added
• Page 6-3 will replaced with may under caution
• Page 10-1 note added
• Page 11-1 Fault Type Interpretation updated
• Page 11-2 Fault codes updated
• Page 11-6 Added
'The above faults will be detected and reported within 1 second of occurring with the exception
of the 400-14 alarm which takes up to 1 minute. This fault code reports a fault in the electrode
identification circuit. This is also checked on power-up, at which time a fault would be detected
and reported immediately (200-71).'
M Matthews - 22-Jul-2011
121393 HF All product labels linked to Manual 277012 to be updated to comply with
60601-third edition updates.
Reason for change
60601-3rd edition requires us to update all labelling including IFU's and
Manuals, to include a new IFU symbol M002 in blue.
BOX LABEL
IFU SYMBOL ISO7010-M002 AND LABEL RE FORMATED. MATERIAL
MATERIAL CHANGED FROM 144105 TO 110022 FOR THE BOX LABELS ONLY.
M Matthews - 07-Mar-2012

TITLE: Gyrus ACMI G400 Workstation USER MANUAL
PART NO./ISSUE: 177012-HH
M Matthews Page 3 of 3
122364 HG To specify voltage overshoot for BiLL and HC modes, the maximum voltages
table (Section 10, page 3) is updated.
Update to the HC load curve graphs (Section 10, page 10) to incorporate
additional data points. Note, this change has been reviewed and agreed by
UL. This is part of the 60601-3rd edition compliance
M Matthews - 03-May-2012
123087 HH Minor updates
Section 4-2 HC2 changed HC3
Section 4-11 image re aligned
M Matthews - 14-Jan-2013

G400 Workstation
USER MANUAL
Manufactured for:
Gyrus ACMI,
136 Turnpike Road
Southborough
MA 01772-2104
USA
Gyrus Medical Ltd
St Mellons
Cardiff
CF3 0LT
United Kingdom
Rx only
Customer Service USA:
Customer Service: 1-888-524-7266
Technical Service: 1-800-621-3739
www.gyrusacmi.com
777000
0344
177012-HH
2013-01

TABLE OF CONTENTS
Gyrus ACMI G400 Workstation USER MANUAL TABLE OF CONTENTS
Part Number: 177012-HH
SECTIONPART PAGE
1 INTRODUCTION
1A Overview of the G400 Workstation 1-1
1B Comparison with Conventional Electrosurgery 1-1
1CIndicationsforUse 1-4
1D Contraindications for Use 1-4
1ESystemDescription 1-4
1F Instrument Description 1-5
2 PATIENT AND OPERATING ROOM SAFETY
2AGeneral 2-1
2BServicing 2-2
2C Equipment Disposal 2-3
2DFire/Explosion 2-3
2EBeforeSurgery 2-3
2FDuringSurgery 2-5
2GAfterSurgery 2-7
2HEMCClassification 2-7
3 INSTALLATION
3A Responsibility of the Manufacturer 3-1
3B G400 Workstation Power Requirements 3-1
3C Grounding of the G400 Workstation 3-1
3D Routine Maintenance of the G400 Workstation 3-1
3E Medical Electrical Systems 3-1
4 GENERAL INFORMATION
4A Gyrus ACMI G400 Workstation Indicators
and Displays 4-1
4B Output Mode Selection and Power Controls 4-4
4C G400 Workstation Indicators, Set-Up
and Malfunction Displays 4-11
4D Video on Screen Display (OSD) Feature 4-15
4E Changing The Display Language 4-16
4F Enabling Additional Instruments via a PIN code 4-17
4G Cutting Progress Indicator Set Up. 4-19
5 BEFORE SURGERY
5A Power up the G400 Workstation 5-1
5B Attach Gyrus ACMI PC & PK Instrument to the G400 Workstation 5-1
6 DURING SURGERY
6A Recommendations During Surgery 6-1
6B PC/PK Default Settings 6-1
6C Activation: Output Selection and Audible Tones 6-1
6D Changing Output Mode and Power Setting During Surgery 6-2
6E Changing Instruments During Surgery 6-2
6F Changing Accessories Between Procedures 6-3
7 TECHNIQUES TO OPTIMIZE PERFORMANCE 7-1
8 AFTER SURGERY
8A Following Surgery 8-1
8B Cleaning the Footswitch 8-1
8C Cleaning the G400 Workstation 8-1
9 OPERATING ROOM TROUBLESHOOTING 9-1
10 PERFORMANCE SPECIFICATIONS 10-1
11 ERROR AND FAULT CODES 11-1
12 EXPLANATION OF SYMBOLS 12-1
13 PERIODIC EQUIPMENT SAFETY CHECKS 13-1
14 EMC TABLES 14-1
15 LIMITED WARRANTY 15-1
16 UL 16-1

………OVERVIEW OF THE GYRUS ACMI G400 GENERATOR .
Gyrus ACMI G400 Workstation USER MANUAL
Part Number: 177012-HH
This user manual will familiarize you with the controls and output functions available from your Gyrus ACMI
G400 Generator and instruct you on its proper use.
Copyright Gyrus Medical, Ltd. 2010. All rights reserved. No part of this
publication may be reproduced, transmitted, transcribed, stored
in retrieval systems, or translated into any language or computer
language, in any form, or by any means: electronic, mechanical,
magnetic, optical, or otherwise, without the prior written
permission of Gyrus ACMI.
G400 GENERATOR
The Gyrus ACMI G400 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 G400 Generator.

SECTION 1 INTRODUCTION
Gyrus ACMI G400 Workstation USER MANUAL
Part Number: 177012-HH Page 1-1
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.

SECTION 1 INTRODUCTION
Gyrus ACMI G400 Workstation USER MANUAL
Part Number: 177012-HH Page 1-2
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 fault indicator
light. Activation “under fault” conditions is inhibited by safety circuitry.
Five 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 vapor-
focused 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.

SECTION 1 INTRODUCTION
Gyrus ACMI G400 Workstation USER MANUAL
Part Number: 177012-HH Page 1-3
• 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.
THERMOKINETIC-T1/T2 (YELLOW PEDAL)
A blended waveform is also available on selected instruments that combined cutting
and Coagulation to provide a degree of hemostasis when cutting.

SECTION 1 INTRODUCTION
Gyrus ACMI G400 Workstation USER MANUAL
Part Number: 177012-HH Page 1-4
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