Olympus Esg-400 User manual

MAINTENANCE / ON-SITE - MANUAL

Electro Surgical Generator

ESG-400

7.022.211 / ISSUE 5

ESG-400

INTRODUCTION

Introduction

The intended use depends on the approval of the country. Refer to the instructions for use of the electrosurgical

unit.

Maintenance instructions

This maintenance manual contains essential information on using and maintaining this electrosurgical

generator safely and effectively. Instructions for the operation of this electrosurgical generator and related

danger, warnings and cautions concerning electrosurgery are beyond the scope of this maintenance manual.

Before using and maintaining, thoroughly review this manual and the instructions for use or maintenance

manuals of all equipment which will be used during maintenance. Use the equipment as instructed. Keep this

manual in a safe, accessible location. If you have any questions or comments about any information in this

maintenance manual, contact Olympus.

Signal words

The following signal words are used throughout this maintenance manual:

DANGER

Indicates an imminently hazardous situation which, if not avoided, will result in

death or serious injury.

WARNING

Indicates a potentially hazardous situation which, if not avoided, could result in

death or serious injury.

CAUTION

Indicates a potentially hazardous situation which, if not avoided, may result in

minor or moderate injury. It may also be used to alert against unsafe practices

or potential equipment damage.

NOTE Indicates additional helpful information.

User qualifications

The user must have received appropriate training in using this electrosurgical generator. The following

instructions are for use by qualified personnel only. Use of this maintenance manual by other individuals is

prohibited. The training will be provided by authorized representatives of Olympus during installation and

commissioning.

NOTE

The user must have received appropriate training in using, servicing,

adjustment, updating and upgrading this electrosurgical generator.

Federal Law of the USArestricts this device to use by, or on the order of, a physician.

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Precautions

High frequency leakage current or spark discharge may cause user burns.

Follow the dangers, warnings and cautions given below when handling and servicing this electrosurgical unit.

This information is to be supplemented by the dangers, warnings and cautions given in each chapter.

User

-related error prevention

WARNING Improper use

The safety and effectiveness of electrosurgical interventions depend not only o

n the design of

the equipment used, but also to a major extent on factors which are under the control of the

user. It is therefore extremely important to read, understand and follow the instructions supplied

with the electrosurgical generator and the accessories in order to ensure safety and

effectiveness.

Always use the electrosurgical generator as outlined in this

maintenance manual. Improper use

will not only impede functions and prevent optimum performance, but may cause equipment

damage and

/ or compl

ications. Before each use, always inspect the equipment as outlined in

this

maintenance manual.

WARNING Annual safety checks / Inspection

The electrosurgical generator and the footswitch must undergo a safety check in yearly intervals

in accordance with

the national statutory regulations (refer to chapter 7 “Inspection”).

Environmental

conditions

CAUTION Interference of the unit with other equipment

Be sure that this electrosurgical unit is not used adjacent to or stacked with other equipment

(other than the components of this electrosurgical unit or system) to avoid electromagnetic

interference.

Before use, thoroughly confirm the compatibility of all equipment.

To ensure electrical safety, the electrosurgical unit should not be used in conjunction w

ith:

•Electrical equipment whose safety against leakage current is not guaranteed.

•Electrosurgical equipment whose safety in combined use is not guaranteed.

The electrosurgical generator complies with the electromagnetic compatibility (EMC) standard.

Never

theless, when the electrosurgical generator is active it may disturb neighboring electronic

equipment. If an auxiliary computer system is in use together with the electrosurgical generator

and endoscopic imaging techniques, the image on the monitor might f

reeze or blackout. Follow

the instructions in “Electromagnetic Compatibility (EMC) information” in the Appendix of the

instruction for use regarding electromagnetic ambient conditions.

Never loop the cords (active cord, bipolar cord, neutral electrode cor

d) or bundle cords together

with cords belonging to other medical equipment. The high frequency signals or spark discharge

noise generated by the unit may interfere with the operation of other medical equipment.

Do not use the electrosurgical unit in a location exposed to strong electromagnetic radiation

(microwave or short

wave medical treatment equipment, Magnetic Resonance Imaging, radio or

mobile phone equipment). Electrosurgical unit malfunction can occur.

CAUTION Unsuitable temperature and humidity

The electrosurgical

generator

should only be used under the conditions as described in chapter

-3 (Limitations). Use under other conditions may impede normal performance and / or result in

equipment damage.

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Accessories

WARNING Mechanical stress

not apply excessive bending, straining, or squeezing force to any cords. It may cause

malfunction.

CAUTION Non-compatible accessories and accessory damage

The electrosurgical generator shall only be used with compatible accessories. When connecting

accessories (cords, electrodes, HF instruments) avoid output settings where the maximum

output voltage of the electrosurgical generator may exceed the rated accessory voltage (refer to

“Mode characteristics”, “Output characteristics” in the Appendix of the ins

truction for use, and the

instruction manual of the accessory). For a list of compatible neutral electrodes, refer to

“Specifications” in the Appendix of the instruction for use.

Before use, the electrosurgical unit and accessories must be examined for damage. All

communication cables and its plugs must be free of scratches and cracks. Cables and

accessories with damaged insulation or connections must not be used.

Electric shock

WARNING Grounding failure

To prevent the risk of electric shock, the housing of the electrosurgical unit must be grounded.

Always connect the power cord plug to a properly grounded wall outlet. Do not use a

-pin / 2-pin adapter, as it can impair safe operation of the unit.

WARNING User shock

To prevent user shock, malfunction

and damage of the electrosurgical unit, keep liquids away

from all electrical equipment.

When taking measurements or troubleshooting of the electrosurgical unit, take appropriate

precautions, such as using isolated tools and equipment, using the “one han

d rule,” etc.

CAUTION Injury during servicing

When the housing is opened, there is a danger of electric shock. The unit must only be serviced

authorized technicians.

Burns

WARNING User

The maximum output voltage characteristics of the electrosurgi

cal generator are shown in the

diagrams in “Output characteristics” in the Appendix of the instruction for use. When setting the

power level, first set it to a low level and increase it gradually. If the output is initially set to a high

level, the electro

de’s insulation may be damaged and cause user and /

or patient burns.

However, certain modes may present an unacceptable risk at low output power settings. For

example, with the PulseCut fast mode or PulseCut slow mode, the risk of an excessive thermal

effect rises if the output power setting is too low. Therefore, it is recommended that you perform

basic testing before using the electrosurgical generator. If the instruction manual of the HF

instrument to be used stipulate a rated voltage, the output should

be set so that it does not

exceed that voltage.

High frequency, high voltage signals that can cause severe burns are present in the

monopolar

/ bipolar sockets described in this maintenance manual. Take appropriate precautions

when testing and troublesho

oting this area of the electrosurgical unit.

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Fire

/ Explosion

DANGER Ignitable anaesthetics / fire supporting gases

The risk of flammable gases or other materials being ignited exists with any contact of electrical

energy. Precautionary measures must be taken to keep flammable materials and substances

away from an active electrosurgical unit (do not use flammable

anesthetics, nitrous oxide or

oxygen). Otherwise, explosion or fire may result and cause serious injuries. This electrosurgical

uni

t is not explosion-proof. Do not use the unit within an explosion zone.

WARNING Ignitable cleaning- and disinfection agents

Flammable agents used for cleaning and disinfection must be allowed to evaporate before the

electrosurgical unit is used and servi

ced.

Non

-flammable agents should be used for cleaning and disinfection wherever possible.

WARNING Risk of fire

Disconnect the power plug before changing the fuses!

Replace fuses as marked. The fuses

must only be replaced by

authorized technicians.

Haz

ards and complications

WARNING Contamination

The electrosurgical unit may be contaminated with infections materials; therefore, all surfaces of

the unit’s housing should be cleaned before servicing according to chapter

1-8 (Cleaning).

WARNING Output performance

Should any abnormal output be suspected during operation, immediately terminate the use of

the equipment by releasing the footswitch. If the footswitch does not react, switch off the

electrosurgical unit. Otherwise, malfunction of the equipment m

ay cause an unintended increase

in output.

WARNING Service persons

Take additional precautions for service technicians, when using the unit’s service operation

mode (see chapter 15, Service operation mode).

CAUTION Unit defect

To prevent electrosurgic

al unit damage, never short-

circuit electrodes (accessories, neutral

electrodes).

In the event of a defect or malfunction in the unit, an undesirably high output power may be

emitted.

DANGER Unit defect

Never use the electrosurgical unit if an abnormality is suspected.

Repair and Maintenance

CAUTION Repair

Repairs must only be carried out by Olympus or a firm authorized by Olympus.

CAUTION Maintenance

Preventive maintenance (inspection / periodic safety check) must only be carried out by a

qualifie

d person / technician.

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Unauthorized reproduction or distribution in part or in whole is prohibited.

Trademarks

OLYMPUS is a registered trademark of the Olympus Corporation.

The company names, product names, and proprietary technical terms in this document are the trademarks or

registered trademarks of their respective owners.

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ESG-400

CONTENT

INTRODUCTION................................................................................................................2

CONTENT..........................................................................................................................7

CHAPTER 1: PRODUCT SPECIFICATIONS ....................................................................9

1 OUTLINE ......................................................................................................................10

1-1 Intended Use....................................................................................................................................10

1-2 Compatibility.....................................................................................................................................10

1-3 Expected service life........................................................................................................................ 10

2 FEATURES...................................................................................................................11

2-1 Application Modes............................................................................................................................ 11

2-2 Accessories......................................................................................................................................12

3 LIMITATIONS................................................................................................................13

4 SPECIFICATIONS ........................................................................................................14

4-1 ELECTROSURGICAL GENERATOR ESG-400 (REF: WB91051W) ..............................................14

4-2 Power cords (4.5 m angled plug)..................................................................................................... 15

4-3 Footswitch (REF: WB50402W, double pedal) .................................................................................16

4-4 Footswitch (REF: WB50403W, single pedal, optional).................................................................... 16

4-5 Neutral electrode cable “P-cord” (REF: MAJ-814, optional)............................................................ 16

4-6 Communication cable 0.25 m (REF: MAJ-1871, optional) ..............................................................17

4-7 Communication cable 10 m (REF: MAJ-1872, optional) ................................................................. 17

4-8 Adapter for UHI-2/3 (REF: MAJ-1873, optional)..............................................................................17

5 NAME AND FUNCTION OF EACH PART....................................................................18

5-1 Symbols and descriptions................................................................................................................ 18

5-1-1 Safety related symbols............................................................................................................18

5-1-2 Front panel .............................................................................................................................. 19

5-1-3 Touch screen...........................................................................................................................19

5-1-4 Rear panel...............................................................................................................................21

5-2 Front panel.......................................................................................................................................22

5-3 Rear panel........................................................................................................................................24

5-4 Bottom panel.................................................................................................................................... 25

5-5 All screen .........................................................................................................................................25

5-6 Set screen........................................................................................................................................26

5-7 Mode screen .................................................................................................................................... 27

5-8 Footswitch with two pedals .............................................................................................................. 28

5-9 Footswitch with one pedal (optional)................................................................................................28

5-10 Neutral electrode cable “P-cord” (optional)...................................................................................... 29

6 CONNECTOR...............................................................................................................30

6-1 Docking Connector .......................................................................................................................... 30

6-2 Monopolar Standard 1......................................................................................................................30

6-3 Monoploar Standard 2 (Erbe)........................................................................................................... 30

6-4 Bipolar Standard 3............................................................................................................................ 30

6-5 Monopolar Neutral Electrode...........................................................................................................31

6-6 Foot switch 1 (SIP/SOP).................................................................................................................. 31

6-7 Foot switch 2 (SIP/SOP).................................................................................................................. 32

7 SYSTEM DIAGRAM .....................................................................................................33

8 CLEANING, STORAGE AND DISPOSAL ....................................................................34

8-1 Cleaning...........................................................................................................................................34

8-2 Storage............................................................................................................................................. 35

8-3 Disposal of the unit .......................................................................................................................... 35

CHAPTER 2: BLOCK DESCRIPTION.............................................................................37

1 BLOCK DESCRIPTIONS..............................................................................................38

1-1 Motherboard..................................................................................................................................... 39

1-2 HVPS Board..................................................................................................................................... 41

1-3 Generator board............................................................................................................................... 41

1-4 Relay Board ..................................................................................................................................... 41

1-5 Front Panel....................................................................................................................................... 42

CHAPTER 3: REPAIR SYSTEM......................................................................................43

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1 ESG-400 MAIN UNIT....................................................................................................44

2 BOARD COMPATIBILITY.............................................................................................44

3 OPTIONAL ACCESSORIES.........................................................................................44

3-1 WB50402W (Footswitch with two pedals) ....................................................................................... 44

3-2 WB50403W (Footswitch with one pedal)......................................................................................... 44

3-3 MAJ-814 (Neutral electrode cable “P-cord”)....................................................................................44

4 PRECAUTIONS ON FUNCTION AND OPERATION SETTINGS.................................44

4-1 General Precautions ........................................................................................................................ 44

CHAPTER 4: TROUBLESHOOTING ..............................................................................45

1 GENERAL.....................................................................................................................46

2 NEUTRAL ELECTRODE OPERATION........................................................................47

3 ERROR SCREEN, CODES AND MEASURES.............................................................48

3-1 What to do when no error code is displayed....................................................................................50

3-2 What to do when an error code is displayed.................................................................................... 54

CHAPTER 5: INSPECTION.............................................................................................73

1 JIGS, TOOLS, AND MEASURING EQUIPMENT FOR INSPECTION..........................74

2 INSPECTION PROCEDURES......................................................................................75

2-1 Visual inspection of the electrosurgical generator and accessories................................................ 76

2-2 Verifying the contact quality monitor function .................................................................................. 80

2-3 Checking the DC resistance (according to IEC 60601-2-2)............................................................. 82

2-4 Checking the earth resistance (according to IEC 60601-1 and IEC 62353)....................................82

2-5 Checking the earth leakage current (according to IEC 60601-1) ....................................................82

2-6 Checking the patient leakage current (according to IEC 60601-1)..................................................83

2-7 Checking the current and power consumption and output waveform..............................................84

2-8 Checking the high frequency leakage current (according to IEC 60601-2-2)..................................86

2-8-1 Measurement of the monopolar high frequency leakage current under loaded condition...... 86

2-8-2 Measurement of the monopolar high frequency leakage current under unloaded condition..88

2-8-3 Measurement of the bipolar high frequency leakage current under loaded condition............90

2-8-4 Measurement of the bipolar high frequency leakage current under unloaded condition........92

2-9 Checking the output power..............................................................................................................94

2-10 Checking for certain features and error messages..........................................................................94

2-11 Final test...........................................................................................................................................95

2-11-1 Self test.................................................................................................................................... 95

2-11-2 Display and sound check ........................................................................................................95

2-11-3 Functionality of push buttons .................................................................................................. 95

2-11-4 Communication test................................................................................................................. 95

2-11-5 Restore of output power settings ............................................................................................96

2-12 Inspection label (For applicable markets)........................................................................................96

3 INSPECTION CARD.....................................................................................................97

CHAPTER 6: DEVICE MENU........................................................................................103

1 SAFETY TEST............................................................................................................104

2 SOFTWARE VERSION...............................................................................................105

CHAPTER 7: REVISION HISTORY...............................................................................107

3 REVISION HISTORY ..................................................................................................108

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CHAPTER 1: PRODUCT SPECIFICATIONS