Gyrus ACMI G400 Workstation User Manual Issue HC Nov 2010

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

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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

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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

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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

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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

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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

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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.

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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.”

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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

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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

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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

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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

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Part Number: 177012-HC

USER MANUAL

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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.

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SECTION 4

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

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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