Gyrus ACMI G400 Workstation User Manual Issue HC Nov 2010

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

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

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

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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

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.

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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.

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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.

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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

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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

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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.

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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.

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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.

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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.

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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.

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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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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

Gyrus ACMI G400 Workstation Part Number: 177012-HC

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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

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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

USER MANUAL

Dependent on instrument insertion

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SECTION 4

GENERAL INFORMATION

A long press will give access to the setup menu, giving access to the following functions below with repeated short presses:      

Display intensity Key click on/off Video OSD Select Language selection Cutting Progress Indicator Set up Enter PIN Code

NOTE

If there is no user activity for a short period, the G400 Workstation will exit the menu and return to the previous state. Entry back to the previous state is also possible by a long press of the button.

Output Displays for PlasmaCision (PC) Instruments with PlasmaBlend output The display is split into a number of sections. The upper portion of the display shows the type of instrument active, that is the instrument that will provide an output when the yellow cut or blue coag pedal is pressed (see Fig 4.2 below) The lower half of the display indicates the output waveform type and power level selected. The lower left section shows the (cut) waveform selection for yellow pedal activation (in this case) HC2 and the power level (50). The specific settings are dependent on the type of instrument attached. The right portion displays the waveform selection for blue pedal activation, (in this case VP3) and the power level (50). The appropriate display will flash and an audible alarm will sound when an output is activated.

PlasmaBlend Waveform

PKS Omni HC3 25

VP3 100

Coagulation Output Waveform

Blue Pedal Coagulation Power

Yellow Pedal PlasmaBlend Power

Fig 4.2

Gyrus ACMI G400 Workstation Part Number: 177012-HC

USER MANUAL

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