PlasmaKinetic SuperPulse Generator User Manual Issue M Nov 2009

8220

F

8340

G

8944

H

100013

J

100994

K

103316

L

Gyrus Inc address change, Suite 105 to Suite 160 & MN 55311-6502 to MN 5531-3602 Add section 2G EMC Classification. Page 10-1 Add to General Weight (18 pounds) change dimensions from 400x400x88mm (16”x16”x4 ½ “) (approx) to 410x410x135mm (16.14”x16.14”x5.3 “) (approx with rubber feet). Add 1000VA to Operating range, change Inlet Fuses from 1000VA to 250VA EMC Tables section 14 added. Limited Warranty section 15 added. PlasmaKinetic changed to PlasmaKinetic®. Change Seal® with SEAL®. Change UL page to shown the C UL CAN/CSA classification & UL601-1 changed to UL60601-1. User Manual principal areas of change have been updates to the endourology manual to include the TS1 and TS2 waveforms including additional load curves; Revisions to the messaging for shorting (1 variant for endourology, and 2 for laparoscopy); Additional explanation of the distinction between automatic and manual socket selection processes; Changes made to outstanding mis-descriptions of messages; and New soft error conditions (eg footswitch faults) replacing recoverable errors. Page 1-3 PlasmaSpatula and PlasmaSeal product description added. Various changes to sections 2, 4, 6 due to software update to version 2.21. Gyrus Medical logo changed to Gyrus ACMI

B Punter

RC

05/01/05

B Punter

R Curtis

13/04/06

B Punter

AF

04/03/06

-

-

-

30/07/07

-

25-JUN-2008

-

11-Nov-2008

CE mark changed from 0123 to 0344. Various minor text changes to make manual consistent. Change to section 4 & 6 due to software release V2.22 Correction made to statement in paragraph 2 on page 7-1. The statement now reads “The N Jones impedance feedback system may indicate a decrease in impedance during activation, with an increasing tone and an increase in the number of stars on the display. “ M MATTHEWS Remove the option to not display the impedance bargraph.

Power up into READY mode instead of STANDBY mode. Press Standby button twice to enter “standby” mode. Dim Display and longer time before entering standby. Add serial number to self checks screen. Replace Gyrus Medical Inc with Gyrus ACMI Inc; replace Maple Grove address with Southborough address. Remove reference to customer service international (non USA) and Winnersh address, replace manufacturer with EC REP symbol and add ACMI to footers and throughout document were Gyrus is present. 104801

M

Add part number to footer to be in line with QSP 4.6 PlasmaKinetic® changed to PlasmaKinetic™ as requested by K. Jarmen Legal. Updated images added for generators.

B Punter

M MATTHEWS

Page 2 of 2

PlasmaKinetic SuperPulse Generator USER MANUAL

Manufactured For:

Gyrus ACMI, Inc. 136 Turnpike Road Southborough MA 01772-2104 USA

Customer Service USA:

Customer Service: 1-800-852-9361 Technical Service: 1-800-621-3739 www.gyrusacmi.com

EC REP

Gyrus Medical Ltd. Fortran Road St Mellons Cardiff CF3 0LT United Kingdom

0344

CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a Physician.

Part Number: 144012-M

TABLE OF CONTENTS SECTION 1

PART 1A 1B 1C 1D 1E 1F 1G

2 2A 2B 2C 2D 2E 2F 2G 3 3A 3B 3C 3D 3E 4 4A 4B 4C 4D 4E 5 5A 5B 5C 6 6A 6B 6C 6D 6E 6F 7 8 8A 8B 8C 8D 9 10 11 12 13 14 15

PAGE INTRODUCTION Overview of the SuperPulse Generator Comparison with Conventional Electrosurgery Indications for Use Contraindications for Use System Description Instrument Description Connector Cable 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 Generator Power Requirements Grounding of the Generator Routine Maintenance of the Superpulse Generator Medical Electrical Systems GENERAL INFORMATION Gyrus ACMI SuperPulse Generator Indicators and Displays Output Mode Selection and Power Controls SuperPulse Generator Indicators, Set-Up and Malfunction Displays Changing the Display Language Enabling Additional Instruments via a PIN code BEFORE SURGERY Power up the Generator Select and Connect the Connector Cable Attach Gyrus ACMI PK Instrument to the PK Connector Cable DURING SURGERY Recommendations During Surgery 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 Generator Cleaning and Sterilizing the PK Connector Cable OPERATING ROOM TROUBLESHOOTING PERFORMANCE SPECIFICATIONS ERROR AND FAULT CODES EXPLANATION OF SYMBOLS PERIODIC EQUIPMENT SAFETY CHECKS EMC TABLES LIMITED WARRANTY

Gyrus ACMI PlasmaKinetic SuperPulse Generator Part Number: 144012-M

USER MANUAL

TABLE OF CONTENTS

1-1 1-1 1-1 1-1 1-2 1-2 1-3 2-1 2-2 2-2 2-3 2-4 2-5 2-5 3-1 3-1 3-1 3-1 3-1 4-1 4-3 4-5 4-9 4-10 5-1 5-1 5-2 6-1 6-1 6-1 6-2 6-2 6-3 7-1 8-1 8-1 8-1 8-2 9-1 10-1 11-1 12-1 13-1 14-1 15-1

INTRODUCTION

SECTION 1

Gyrus Medical Ltd, Gyrus Medical Inc and Gyrus International Ltd are referred to as Gyrus ACMI in this user manual. This user’s manual will familiarize you with the controls and output functions available from your SuperPulse Generator and instruct you on its proper use. 1A.

Overview of the SuperPulse Generator Bipolar electrosurgery is a familiar tool widely employed in surgery. Based on similar principles, the Gyrus ACMI PlasmaKinetic (PK) technology combined with Gyrus ACMI PK instruments provides more effective coagulation and cutting of tissues than when similar instruments are used with other electrosurgical generators. A key feature of the Gyrus ACMI SuperPulse Generator is the capability of the generator to identify the type of Gyrus ACMI PK instrument connected to it. The identification of the instrument causes the generator to operate in the PlasmaKinetic (PK) mode that selects a default output designed to produce the desired electrosurgical effect for that particular instrument. This feature provides additional convenience for the user of the device. The user can change this default to obtain a wider range of PlasmaKinetic outputs from the device.

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 Generator when used with Gyrus ACMI PK instruments that distinguishes it from conventional bipolar generators. •

Vapor Pulse Coagulation (VPC) VPC produces controlled coagulation of vascular pedicles using vapor-focused pulses of energy. VPC has been specifically tailored for delivery through Gyrus ACMI PK Instruments. Once tissue to be coagulated is grasped in a PK Instrument, the tissue is uniquely coagulated 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.

•

PlasmaKinetic

Tissue Cutting (PK)

In the PK output mode, the energy is used to create an ionized plasma around one pole of a Gyrus ACMI PK instrument. The ‘active’ pole provides tissue cutting and a level of hemostasis dependent on the selected PK output. This mode utilizes the conductive properties of fluids, both those released from tissues during application as well as saline commonly used to irrigate the body cavity. 1C.

Indications for Use The SuperPulse Generator is a general surgical electrosurgical device intended for use with bipolar instruments used in open, endoscopic and laparoscopic surgical procedures involving the coagulation and cutting of soft tissue. The device 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 Use with caution in the presence of internal or external pacemakers. 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 hospital Cardiology Department.

Gyrus ACMI PlasmaKinetic SuperPulse Generator Part Number: 144012-M

USER MANUAL

Page 1-1

INTRODUCTION

SECTION 1

1E.

System Description The SuperPulse Generator (figure 1.1) is designed for use in surgery for the coagulation and cutting of soft tissue. A typical system setup would comprise of the following items: • • • •

Generator Footswitch Re-usable Connector Cable Gyrus ACMI PK surgical instruments and other bipolar surgical instruments.

Fig 1.1 1F.

Instrument Description The instruments below are designed and rated to be used with the Generator. For convenience and to improve safety during use, all the dedicated instruments have an internal classification code, which is interrogated by the Generator 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.

Gyrus ACMI PlasmaKinetic SuperPulse Generator Part Number: 144012-M

USER MANUAL

Page 1-2

INTRODUCTION

SECTION 1 Instrument types: Model No Description PlasmaKinetic

PlasmaKinetic

PlasmaKinetic PlasmaKinetic Lyons

Molly

Forceps

Cutting Forceps

LP Scissors Needle Electrode

Dissecting Forceps

PlasmaKinetic PlasmaKinetic PlasmaKinetic

Forceps Macro-Jaw Forceps Micro-Jaw L-Hook

Connector Cable

3300PK 33 cm 3 mm Forceps

3 Pin

3301PK 33 cm 3 mm Forceps w/Trocar

3 Pin

3330PK 33 cm 5 mm Forceps

3 Pin

3345PK 45 cm 5mm Forceps

3 Pin

3000PK 33 cm 10mm Cutting Forceps

3 Pin

3001PK 33 cm 10mm Cutting Forceps w/cord

3 Pin

3005PK 33 cm Cutting Forceps

3 Pin

3006PK 33 cm Cutting Forceps w/cord

3 Pin

3045PK 45 cm Cutting Forceps

3 Pin

3804PK 33 cm LP Scissors

3 Pin

3844PK 45 cm LP Scissors

3 Pin

3400PK 33 cm Needle Electrode

3 Pin

3700PK 33 cm Dissecting Forceps

3 Pin

3740PK 45 cm Dissecting Forceps

3 Pin

3600PK 33 cm Macro-Jaw Forceps

3 Pin

3640PK 45 cm Micro-Jaw Forceps

3 Pin

3601PK 33 cm Macro-Jaw Forceps

3 Pin

3641PK 45 cm Micro-Jaw Forceps

3 Pin

3527PK 33 cm L-Hook

3 Pin

PK SEAL

Open Forcep, Curved

3103PK 25 cm (9¾”) Seal Open Forcep, Curved 3 Pin

PK SEAL

Open Forcep, Straight

3104PK 25 cm (9¾”) Seal Open Forcep, Straight 3 Pin

PK SEAL

Open Forcep, Angle

3105PK 25 cm (9¾”) Seal Open Forcep, Angle

3 Pin

PlasmaSpatula

3220PK 24cm Plasma Spatula

5 Pin

PlasmaSpatula

3200PK 33cm Plasma Spatula

5 Pin

PlasmaSpatula

3240PK 45cm Plasma Spatula

5 Pin

®

PlasmaSEAL 1G.

Open Forcep, Curved

®

2103PK PlasmaSEAL Open Forcep, Curved

5 Pin

Connector Cable Description The connector cable is designed and rated for 20 uses with the Generator and Instruments. The Connector Cable is supplied non sterile and should be sterilized before use in accordance with its instructions.

Cable types: Model No

Description

PlasmaKinetic

Single Function

3900

3 Pin

PlasmaKinetic

Dual Function

3905

5 Pin

Gyrus ACMI PlasmaKinetic SuperPulse Generator Part Number: 144012-M

USER MANUAL

Page 1-3

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. Electrosurgery has been employed safely in numerous procedures. 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 Do not use a monopolar generator/accessories simultaneously with the SP generator. Activation of a monopolar generator/accessories may cause interference with the SP generator resulting in user message changes on the display. Before proceeding with surgery, confirm proper power settings are displayed on the generator. Ensure the appropriate output setting is enabled for the desired surgical outcome. WARNING Direct contact between activated monopolar accessories and SP generator connected accessories could damage the SP generator. If such damage is suspected, the SP generator should be returned to Gyrus ACMI for inspection. WARNING Use with caution in the presence of internal or external pacemakers. 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 hospital Cardiology Department. WARNING Do not use electrosurgical equipment unless properly trained in its use in the specific procedure intended. WARNING Electrodes 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 electrode site, place the electrode and / or probe as far away as possible from the electrosurgical site. CAUTION

If two accessories are connected to the SP generator, ensure the appropriate accessory is selected prior to activation. Activation of the unintended accessory could cause unintentional tissue effect.

CAUTION

Do not activate electrodes while in contact with other instruments as unintended tissue effect may occur.

CAUTION

Do not activate the generator in an open circuit condition. To reduce the risk of unintended effects, activate the generator only when the active accessory 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 PlasmaKinetic System accessories before use. This device is an integral system; only use Gyrus ACMI approved accessories with the Gyrus ACMI Superpulse Generator.

Gyrus ACMI PlasmaKinetic SuperPulse Generator Part Number: 144012-M

USER MANUAL

Page 2-1

PATIENT AND OPERATING ROOM SAFETY

SECTION 2 CAUTION

If possible, avoid the use of needle style instruments for any physiological monitoring equipment that may be connected to the patient during electrosurgery.

CAUTION

Where practical, only use monitoring equipment that incorporates high frequency current limiting devices during electrosurgical procedures.

CAUTION

The connector 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 electrosurgical generator 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.

WARNING The PK or SP system has not been cleared for tubal sterilization. Do not use this system for these procedures. 2B.

2C.

Servicing/Equipment Disposal CAUTION

Electrical Shock Hazard: Do not tamper with the generator housing or attempt to remove the control panel. Refer to authorized personnel for service.

NOTE

1. 2.

CAUTION

The generator 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.

There are no user serviceable parts within the product. For maintenance of the generator, refer to the recommended periodic equipment safety checks in Section 13.

Fire/Explosion DANGER

Explosion Hazard: Do not use in the presence of flammable anesthetics.

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 mopped up before electrosurgery is used. Endogenous gases.

•

Gyrus ACMI PlasmaKinetic SuperPulse Generator Part Number: 144012-M

USER MANUAL

Page 2-2

PATIENT AND OPERATING ROOM SAFETY

SECTION 2 • •

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. 2D.

Before Surgery Active Accessories WARNING Electric Shock Hazard: Do not connect wet accessories to the generator. WARNING Electric Shock Hazard: Ensure that all accessories are correctly connected and that no metal is exposed. WARNING Do not attempt to re-use instruments labeled for Single Use Only. Heat or chemical Sterilization may render the instrument mechanically or electrically unsafe CAUTION

Read the instructions, warnings and cautions provided with the instrument accessories before using.

CAUTION

Accessories 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 accessory.

CAUTION

Always inspect the system accessories for damage prior to use. In particular, check the cables of any re-usable accessory for possible insulation damage.

CAUTION

Use only Gyrus ACMI approved accessories supplied for use with this product. Product damage or accessory failure may otherwise result during use.

SuperPulse Generator WARNING Electric Shock Hazard; Connect the generator power cord to a properly grounded receptacle. Do not use power plug adapters. WARNING Fire Hazard; Do not use extension cords. CAUTION

Provide as much distance as possible between the generator and other electronic equipment (such as monitors) as an activated generator may cause interference with them.

CAUTION

Non-function of the generator may cause interruption of surgery. Ensure that all installation procedures are followed and that all connectors are correctly inserted before use. A backup generator should be available for use.

Gyrus ACMI PlasmaKinetic SuperPulse Generator Part Number: 144012-M

USER MANUAL

Page 2-3

PATIENT AND OPERATING ROOM SAFETY

SECTION 2

2E.

CAUTION

Do not stack equipment on top of the generator or place the generator 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.

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. Do not activate in contact with another metal object. Localized heating of the instrument and the adjacent metal object may result in product damage or inadvertent injury. WARNING While using electrosurgery during a surgical procedure, the patient should not be allowed to come into direct contact with grounded metal objects (e.g., surgical table frame, instrument table, etc.). If this is not possible, use extreme caution to maximize patient safety. The use of antistatic sheeting is recommended for this purpose SuperPulse Generator Power Settings WARNING Do not simultaneously activate the SuperPulse Generator whilst 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. CAUTION

Upon reconnection of an instrument to the SuperPulse Generator, 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 generator 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.

CAUTION

Use caution when overriding the default power settings.

CAUTION

Should a power supply interruption occur, the generator will revert to its Standby state. The user should press the standby/on button to restart the generator and then press the Mode / Menu button on the front panel to accept the default instrument settings.

Instrument Accessories WARNING When not in use, place 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. 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 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. Gyrus ACMI PlasmaKinetic SuperPulse Generator Part Number: 144012-M

USER MANUAL

Page 2-4

PATIENT AND OPERATING ROOM SAFETY

SECTION 2

Endoscopic Procedures WARNING As visualization may be impaired during endoscopy for a number of reasons, be particularly alert to these potential hazards:

2F.

• •

Ensure the tip of the instrument is visible before activation.

•

Inadvertent activation or movement of activated electrodes outside of the field of vision may result in injury to the patient.

•

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 while activated.

•

Carefully insert and withdraw instruments from 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.

After Surgery WARNING Electric Shock Hazard. Always unplug the generator before cleaning. CAUTION Do not reuse or resterilize accessories labeled “disposable” or “single use only.”

2G

EMC Classification The SuperPulse System 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 generator should not be used adjacent to or stacked with other electrical equipment. If adjacent or stacked use is necessary both the generator and other equipment should be observed to verify normal operation in the configuration in which it will be used.

•

The EMC classification of the SuperPulse system (class A) is suitable for use on dedicated supply systems not connected to the public mains network, such as hospitals. 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.

Gyrus ACMI PlasmaKinetic SuperPulse Generator Part Number: 144012-M

USER MANUAL

Page 2-5

SECTION 2

PATIENT AND OPERATING ROOM SAFETY

•

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 SuperPulse generator. Activation of a monopolar generator/accessories may cause interference with the SuperPulse generator resulting in user message changes on the display. Before proceeding with surgery, confirm proper power settings are displayed on the generator. Ensure the appropriate output setting is enabled for the desired surgical outcome.

•

Provide as much separation as possible between the generator and other electronic equipment (such as monitors). When activating the generator, unintended electromagnetic coupling may cause interference with the other equipment.

•

Should any unintentional effects appear upon other equipment when using the generator, repositioning the generator, 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 PlasmaKinetic SuperPulse Generator Part Number: 144012-M

USER MANUAL

Page 2-6

SECTION 3

INSTALLATION

The electrosurgical generator described in this manual, in conjunction with the Gyrus ACMI PK Instruments, is designed to provide advanced electrosurgical effects during endoscopic 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.

3B.

Generator Power Requirements Please refer to section 10-1 for full voltage details. Check the Generator 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 generator, cords should always be grasped by the plug. Do not pull on the cord itself.

3C.

Grounding of the Generator To ensure user safety, the generator must be properly grounded through the inlet plug and power cord. Use only hospital grade power cords. IMPORTANT

Ensure that the electrical installation of the relevant room complies with local codes and regulatory requirements.

3D. Routine Maintenance of the Superpulse Generator It is recommended that the generator be inspected by qualified service personnel in accordance with Section 13, Periodic Equipment Safety Checks. 3E. Medical Electrical Systems When the Superpulse generator 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 Superpulse generator is to be placed outside the patient environment. The Superpulse generator footswitch accessory is to be placed outside the sterile field. The instruments intended for use with the Superpulse generator are suitable for use inside the patient environment. WARNING Multiple portable socket outlets shall not be placed on the floor. WARNING

Additional multiple portable socket outlets or extension cords shall NOT be connected to the system.

Gyrus ACMI PlasmaKinetic SuperPulse Generator Part Number: 144012-M

USER MANUAL

Page 3-1

SECTION 4 4A.

GENERAL INFORMATION

Gyrus ACMI SuperPulse Generator Indicators and Displays

Red warning lamp

Gyrus Medical Ltd Superpulse System (c) 2003 Version V2.22

PlasmaKinetic and ThermoKinetic Up/Down

Mode / Menu Button

Standby / On Button

Standby / On indicator

Active instrument indicator Connector Cable sockets

Vapor Pulse and Des Up/Down

Fig 4.1 Keypad: Standby/On, Up, Down Arrows and Mode / Menu Button Standby / On The Standby/On button switches the Generator 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 again to confirm entry to Standby is required. Following an error condition the generator may be reset by pressing the Standby/On button twice. Up/Down Arrows Depressing the up or down arrow 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 button provides access into the waveform selection and setup menus. Repeated short presses will give access to the frequently used functions, listed below: • • •

Cut waveform selection (PK) Coagulation waveform selection (VP/DES) Volume

Gyrus ACMI PlasmaKinetic SuperPulse Generator Part Number: 144012-M

USER MANUAL

Page 4-1

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: • • • • NOTE

Display intensity Key click on/off Select language Enter PIN Code If there is no user activity for a short period, the generator will exit the menu and return to the previous state.

When a PK connector cable is attached, the symbol below appears on the display.

3 Way Cable attached Insert Device

Fig 4.2 Screen for one 3-Way PK cable installed on the selected socket. 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, 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 VPC mode is only available with Gyrus ACMI PK instruments. The appropriate display will flash and an audible alarm will sound when an output is activated.

Needle / Hook PK1 40

VP1 20

Fig 4.3 Screen for Needle or Hook selected NOTE

The PK output is not available for some PK instruments. The lower left hand portion of the display remains blank in this case.

Gyrus ACMI PlasmaKinetic SuperPulse Generator Part Number: 144012-M

USER MANUAL

Page 4-2

SECTION 4

4B.

GENERAL INFORMATION

Output Mode Selection and Power Controls When using a Gyrus ACMI PK instrument, the generator default power, and waveforms for that instrument will be selected. Power Up/Down - These buttons adjust the power setting; the yellow arrow buttons for the PlasmaKinetic (PK) and ThermoKinetic (T) outputs, and the blue arrow buttons for the Vapor Pulse Coagulation (VPC) and Desiccate (DES) 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 generator.

PlasmaKinetic Cut

PK3 PK2 PK1

High impedance tissue (fatty, vascular tissue) Medium impedance tissue Low impedance tissue (thin tissue) Voltage increasing

ThermoKinetic Cut

T2 T1

High impedance tissue (fatty, vascular tissue) Low impedance tissue (thin tissue) Voltage increasing

Coagulation

DES VP3 VP2 VP1

General Purpose, Non tissue-specific desiccation High impedance tissue (fatty, vascular tissue) Medium impedance tissue Low impedance tissue (thin tissue) Voltage increasing

NOTE

Output mode selection can only be performed with an instrument and connector cable attached to the generator. The range of modes available will depend on the type of Gyrus ACMI PK instrument being used.

NOTE

If the Mode / Menu button on the front panel is quickly pressed and released the generator enters a configuration state, pressing and holding the Mode / Menu button at any time exits this state.

Mode Selection using Gyrus ACMI PK Instruments - There are three PlasmaKinetic Modes shown as PK1, PK2 and PK3 that produce a tissue effect increasing from PK1 to PK3 (PK3 delivers power more effectively to higher impedance tissue than PK1). 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. Three VPC mode levels and the desiccate (DES) are available. VP1 is optimal for low impedance tissue, VP2 for intermediate impedance tissue and VP3 for higher impedance tissue or larger diameter instruments. 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. DES provides a conventional continuous bipolar output. The modes associated with the blue and yellow pedals can be individually assigned. To change to desired mode press the Mode / Menu button until it is seen on the display (yellow pedal mode appear on the LHS and blue pedal mode on the RHS). Using the UP/DOWN buttons as indicated on the screen, will cycle through the available modes for the respective pedal (see Fig 4.4 Screen for coag waveform selection below). Gyrus ACMI PlasmaKinetic SuperPulse Generator Part Number: 144012-M

USER MANUAL

Page 4-3

SECTION 4

GENERAL INFORMATION

When the desired mode is displayed, a further press on the Mode / Menu button will complete the selection

Select Mode DES

Fig 4.4 Screen for coag waveform selection Socket Selection The generator permits two instruments to be fitted simultaneously, via the two 5-way connectors. Only one socket can deliver RF at any one time. When the generator is switched on from the standby state, it initially operates an automatic socket selection mechanism, and assists primary connection by activating whichever socket first has an instrument attached. The instrument connected to the active socket is indicated on the display. Thereafter socket selection can only be altered manually, by pressing the black mode footswitch, ensuring that the surgeon always has control over which instrument is activated. Black Mode Footswitch

Fig 4.5 Footswitch Footswitch - Blue Pedal The blue footswitch pedal is used to administer desiccate and VP output waveforms. The output will be present while the footswitch is held down. Footswitch – Yellow Pedal The yellow footswitch pedal is used to administer PK (cut) and ThermoKinetic waveforms. The output will be present while the footswitch is held down. Footswitch – Black Mode Footswitch The black mode footswitch enables a rapid change between PK instruments.

Gyrus ACMI PlasmaKinetic SuperPulse Generator Part Number: 144012-M

USER MANUAL

Page 4-4

SECTION 4

GENERAL INFORMATION

Generator Switch On/Off The mains power On/Off rocker switch is located on the top left of the rear panel (viewed from front). The Generator is switched on by pressing the side marked l. The generator will display the Serial number of the generator, then the internal tests are performed then the green LED below the Mode / Menu button will come on continuously, then flash after a short time. The generator is then Ready state dependent on whether an instrument has been fitted. The generator display will dim after a period of 30 minutes of not being used and will automatically enter Standby state if it is not used for a period of four hours. It is advisable to switch off the Generator whenever it is not in use for any extended period, by using the rear panel switch. The side marked “0” should be pressed to do this. To enable use of the generator the Standby / On button must be pressed and the generator will then enter the Idle state if no instrument is fitted, or the Ready state if an instrument is fitted. If an instrument is present at switch on then the user has to accept the default powers, by pressing the Mode / Menu button when prompted. 4C.

SuperPulse Generator Indicators, Set-up and Malfunction Displays Impedance Indicator Impedance is measured by the generator to provide assistance in determining the tissue effect endpoint, in addition to the visual and tactile feedback available to the user. The impedance of the tissue rises during the desiccation/coagulation process. Indication of this is provided via audible and visual signals to be used as a guide to determining when treatment is complete. The impedance indication is available as a bargraph with audible indication, or the indications can be removed if desired. The impedance display is in the form of a bar graph. For the bargraph display thirteen diamonds are displayed initially with the number reducing as the impedance rises.

Gyrus ACMI PlasmaKinetic SuperPulse Generator Part Number: 144012-M

USER MANUAL

Page 4-5

SECTION 4

GENERAL INFORMATION

The audible tone that accompanies the visual display starts at a high pitch and falls as the impedance increases.

Activation Status Activate - When the generator is activated, the power display of the selected output flashes and an audible tone sounds. If neither occurs, then there is a malfunction. Activate Tones and Impedance Indicator Volume Adjustment Volume Adjustment - The activation tone volume can be adjusted between minimum and maximum using the up control of the desiccate (blue) power control. Depress and release the Mode / Menu button until the symbol “SELECT VOLUME” appears (Fig 4.6 Screen for Alarm volume selection). Press and release the Mode / Menu button once more to accept the setting.

Select volume 1

10

Fig 4.6 Screen for Alarm volume selection System Failure Displays Non-critical (Soft) Faults Shorting For jawed or grasping Gyrus ACMI PK instruments, if an instrument short occurs an oscillating audible alert is sounded and the display shows the symbol “Regrasp”. The surgeon should release the instrument jaw and reposition the tissue.

T2 40

VP2 30

Regrasp

Fig 4.7 Screen for the selected PK electrode shorted

Gyrus ACMI PlasmaKinetic SuperPulse Generator Part Number: 144012-M

USER MANUAL

Page 4-6