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
PAGE:
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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

SECTION 1 INTRODUCTION
Gyrus ACMI G400 Workstation USER MANUAL
Part Number: 177012-HH Page 1-5
1F. 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 Accessories (in model # order)
Model # Description
962000PK PKS PlasmaSORD Morcellator
BL0533 33 cm PKS
TM
BiLL
TM
, w/ Cord
744010 G400 Footswitch
Note: The above devices have been classified by UL.
The accessories in the preceding list are compatible with the G400 Workstation. These
devices have been assessed by an independent certification body and shown to be complaint
with EN60601-1:2006 and EN60601-2-2:2009.
Note: These devices have not been classified by UL
Model # Description
IDC-0130 G400 Video Cable Accessory
710003 Dual Footswitch Connector Cable
700000 CART,SP/G400 GENERATOR
The accessories in the preceding list are compatible with the G400 Workstation.
Note: These devices have not been classified by UL
WARNING Read the instructions, cautions, and warnings provided with all Gyrus ACMI
G400 Workstation accessories before use. This device is an integral system;
Model # Description
910000PK PKS MOLLY FCP,3MM 33CM, 9-PIN (5/PK)
910005PK PKS MOLLY FCP,9-PIN 5MM/33CM (5/PK)
910010PK PKS,MOLLY FCPS,45CM 9-PIN (5/PK)
915000PK PKS SEAL,OPEN FCP 9-PIN,CURVE (5/PK)
920000PK PKS CUT/FCPS 5MM/24CM 9-PIN (5/PK)
920005PK PKS CUT/FCP, 5MM/33CM 9-PIN (5/PK)
920010PK PKS CUT/FCP,5MM/45CM 9-PIN (5/PK)
921015PK PKS CUT/FCP,10MM/15CM 9-PIN (5/PK)
921020PK PKS CUT/FCP,10MM/33CM (5/PK)
942000PK PKS DISSECTOR,24CM 9-PIN (5/PK)
942005PK PKS DISSECTOR,33CM 9-PIN (5/PK)
942010PK PKS DISSECTOR,45CM 9-PIN (5/PK)
950000PK PKS NEEDLE, 33CM 9-PIN (5/PK)
952005PK 33 CM PKS PLASMASPATULA W/CORD (5/PK)
954000PK PKS L-HOOK, 33CM 9-PIN (5/PK)
954005PK PKS L-HOOK, 45CM 9-PIN (5/PK)
956000PC PLASMA J-HOOK 15CM
956005PC PLASMA J-HOOK 24CM
956010PC PLASMA J-HOOK W/CORD 33CM
956015PC PLASMA J-HOOK 45CM
960000PK PKS LP SCISSORS,33CM 9-PIN (5/PK)
970000PC MODEL 970000PC, 5 PACK, 15CM, OMNI PKS
970005PC MODEL 970005PC, 5 PACK, 24CM, OMNI PKS
970010PC MODEL 970010PC, 5 PACK, 33CM, OMNI PKS
970015PC MODEL 970015PC, 5 PACK, 45CM, OMNI PKS
HACF0533 HALO PKS CUTTING FORCEPS,5mm/33cm

SECTION 1 INTRODUCTION
Gyrus ACMI G400 Workstation USER MANUAL
Part Number: 177012-HH Page 1-6
only use Gyrus ACMI approved accessories with the Gyrus ACMI G400
Workstation.
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.

SECTION 2 PATIENT AND OPERATING ROOM SAFETY
Gyrus ACMI G400 Workstation USER MANUAL
Part Number: 177012-HH Page 2-1
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 No modification to the equipment is allowed.
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.

SECTION 2 PATIENT AND OPERATING ROOM SAFETY
Gyrus ACMI G400 Workstation USER MANUAL
Part Number: 177012-HH Page 2-2
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.
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.
WARNING Read the instructions, cautions and warnings provided with all 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. It is recommended
that a suitable extraction method is employed.
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.
WARNING All high frequency electrosurgical devices can potentially cause muscle
stimulation during use. The G400 system has been designed such that this
undesirable effect is minimised, however, muscle stimulation may cause
unexpected movement of the patient within the surgical field.
2B. 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. There are no user serviceable parts within the product.
2. For maintenance of the G400 Workstation, refer to the recommended
periodic equipment safety checks in Section 13.

SECTION 2 PATIENT AND OPERATING ROOM SAFETY
Gyrus ACMI G400 Workstation USER MANUAL
Part Number: 177012-HH Page 2-3
2C. EQUIPMENT DISPOSALS
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.
2D. 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.
WARNING 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.

SECTION 2 PATIENT AND OPERATING ROOM SAFETY
Gyrus ACMI G400 Workstation USER MANUAL
Part Number: 177012-HH Page 2-4
2E. BEFORE SURGERY
Instrument and Accessories
WARNING Electric Shock Hazard: Do not connect wet accessories to the G400
Workstation.
WARNING To avoid the risk of electric shock this equipment must only be connected to a
SUPPLY MAINS with protective earth.
WARNING Ensure that the generator is positioned so that the ability to disconnect or isolate
from the mains supply is not restricted.
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 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.

SECTION 2 PATIENT AND OPERATING ROOM SAFETY
Gyrus ACMI G400 Workstation USER MANUAL
Part Number: 177012-HH Page 2-5
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).
WARNING 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.
CAUTION Regularly inspect the cables of all accessories for possible damage to the
insulation prior to use.
2F. 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
CAUTION Skin to skin contact (for example between the arms and body of the patient)
should be avoided, for example by insertion of dry gauze.
CAUTION Unused active electrodes should be stored in a temporary sterile location
isolated from patient.
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.

SECTION 2 PATIENT AND OPERATING ROOM SAFETY
Gyrus ACMI G400 Workstation USER MANUAL
Part Number: 177012-HH Page 2-6
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.
WARNING 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.
CAUTION Use caution when overriding the default power settings. Always use the lowest
power setting to achieve the required surgical effect.
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.
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.
CAUTION Fluids pooled in the body depressions and cavities should be removed before
the use of HF surgical equipment.
Laparoscopic Procedures
WARNING If visualization becomes impaired during endoscopy be particularly alert to these
potential hazards:
Ensure the tip of the instrument is visible before and during activation.

SECTION 2 PATIENT AND OPERATING ROOM SAFETY
Gyrus ACMI G400 Workstation USER MANUAL
Part Number: 177012-HH Page 2-7
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.
Carefully insert and withdraw instruments from cannulas/trocars to avoid
the possibility of damage to the devices and/or injury to the patient.
CAUTION Tissue effects may vary in presence of CO2
2G. 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.”
2H. 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.

SECTION 2 PATIENT AND OPERATING ROOM SAFETY
Gyrus ACMI G400 Workstation USER MANUAL
Part Number: 177012-HH Page 2-8
• 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