OLYMPUS

OLYMPUS Electrosurgical Units / Ultrasonic Generator Systems

ESG-400 ELECTRO SURGICAL GENERATOR Maintenance-On-Site Manual

Maintenance-On-Site Manual

110 Pages

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File Name: ESG-400 Electrosurgical Generator Maintenance-On-Site Manual.pdf

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Page 1

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 USA restricts this device to use by, or on the order of, a physician.

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Introduction

ESG-400 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 on 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 complications. 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 with: •

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. Nevertheless, 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 freeze 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 cord) 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 1-3 (Limitations). Use under other conditions may impede normal performance and / or result in equipment damage.

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Introduction

ESG-400

Accessories WARNING

Mechanical stress

Do 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 instruction 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 3-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 hand rule,” etc. CAUTION

Injury during servicing

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

Burns WARNING

User

The maximum output voltage characteristics of the electrosurgical 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 electrode’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 troubleshooting this area of the electrosurgical unit.

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Introduction

ESG-400

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 unit 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 serviced. 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.

Hazards 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 may 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 electrosurgical 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 qualified person / technician.

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Introduction

ESG-400

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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Introduction

ESG-400

CONTENT INTRODUCTION ... 2 CONTENT ... 7 CHAPTER 1: PRODUCT SPECIFICATIONS ... 9 1 OUTLINE ... 10 1-1 1-2 1-3

Intended Use ... 10 Compatibility... 10 Expected service life ... 10

2 FEATURES ... 11 2-1 2-2

Application Modes ... 11 Accessories ... 12

3 LIMITATIONS ... 13 4 SPECIFICATIONS ... 14 4-1 4-2 4-3 4-4 4-5 4-6 4-7 4-8

ELECTROSURGICAL GENERATOR ESG-400 (REF: WB91051W) ... 14 Power cords (4.5 m angled plug) ... 15 Footswitch (REF: WB50402W, double pedal) ... 16 Footswitch (REF: WB50403W, single pedal, optional) ... 16 Neutral electrode cable “P-cord” (REF: MAJ-814, optional) ... 16 Communication cable 0.25 m (REF: MAJ-1871, optional) ... 17 Communication cable 10 m (REF: MAJ-1872, optional) ... 17 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 6-2 6-3 6-4 6-5 6-6 6-7

Docking Connector ... 30 Monopolar Standard 1 ... 30 Monoploar Standard 2 (Erbe) ... 30 Bipolar Standard 3... 30 Monopolar Neutral Electrode ... 31 Foot switch 1 (SIP/SOP) ... 31 Foot switch 2 (SIP/SOP) ... 32

7 SYSTEM DIAGRAM ... 33 8 CLEANING, STORAGE AND DISPOSAL ... 34 8-1 8-2 8-3

Cleaning ... 34 Storage ... 35 Disposal of the unit ... 35

CHAPTER 2: BLOCK DESCRIPTION... 37 1 BLOCK DESCRIPTIONS ... 38 1-1 1-2 1-3 1-4 1-5

Motherboard ... 39 HVPS Board ... 41 Generator board ... 41 Relay Board ... 41 Front Panel... 42

CHAPTER 3: REPAIR SYSTEM ... 43 7.022.211 / ISSUE 5

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Content

ESG-400

1 ESG-400 MAIN UNIT ... 44 2 BOARD COMPATIBILITY ... 44 3 OPTIONAL ACCESSORIES ... 44 3-1 3-2 3-3

WB50402W (Footswitch with two pedals) ... 44 WB50403W (Footswitch with one pedal) ... 44 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 3-2

What to do when no error code is displayed ... 50 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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Content

ESG-400

CHAPTER 1: PRODUCT SPECIFICATIONS 1 OUTLINE ... 10 1-1 1-2 1-3

Intended Use ... 10 Compatibility... 10 Expected service life ... 10

2 FEATURES ... 11 2-1 2-2

Application Modes ... 11 Accessories ... 12

3 LIMITATIONS ... 13 4 SPECIFICATIONS ... 14 4-1 4-2 4-3 4-4 4-5 4-6 4-7 4-8

6 CONNECTOR ... 30 6-1 6-2 6-3 6-4 6-5 6-6 6-7

7 SYSTEM DIAGRAM ... 33 8 CLEANING, STORAGE AND DISPOSAL ... 34 8-1 8-2 8-3

Cleaning ... 34 Storage ... 35 Disposal of the unit ... 35

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Chapter 1: PRODUCT SPECIFICATIONs

ESG-400

1 Outline 1-1

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

1-2

Compatibility This product can be used in combination with the products listed in compatibility table.

1-3

Expected service life The expected service life is 10 years.

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Chapter 1: PRODUCT SPECIFICATIONs

ESG-400

2 Features The ESG-400 is a reusable, non-sterile electrosurgical generator with different mono- and bipolar cutting and coagulation modes. The maximum output power is 320 W. On the front side it features a touch screen display that displays the connection status of accessories and peripherals connected to the electrosurgical generator. It is also used to show and modify the output settings (e.g. mode, output power, effect) as well as to control other functions (e.g. save settings). In addition the ESG-400 has a bipolar socket, two monopolar sockets, a neutral electrode socket, and a universal socket to connect applicators with instrument recognition. The power switch turns the generator on and off. Two contact quality indicators (one for split and one for non-split electrodes) are green illuminated if neutral electrodes are correctly connected. Three additional push buttons allow recalling a previously saved setting (Select Procedure), to assign the footswitches to specific output sockets (Footswitch), and to control several other functions (Menu), e.g. select language, touch tone control, output volume, or brightness. On the rear panel the volume control, a ventilation hole, the equipotential bonding point, the AC power socket, and two footswitch sockets can be found. Furthermore, for the connection of peripheral equipment 26-pin plugs respectively 14-pin plugs can be connected to the LINK-IN or to the LINK-OUT socket. On the bottom panel, a docking socket is featured. It can be used to connect the ESG-400 directly to the USG-400 and upcoming devices. The ESG-400 is compatible with the new USG-400 ultrasonic generator to enable the use of combined (US + HF) instruments.

2-1

Application Modes Monopolar Cut: •

PureCut (Cutting of varying tissue structures; 3 Effects)

•

BlendCut (Cutting of varying tissue structures; 3 Effects)

•

PulseCut slow (Intermittent cutting; 3 Effects)

•

PulseCut fast (Intermittent cutting; 3 Effects)

Monopolar Coagulation: •

SoftCoag (Coagulation of tissue with little sticking and carbonization; 3 Effects)

•

ForcedCoag (Fast and effective coagulation; 3 Effects)

•

SprayCoag (Contact-free surface coagulation with little penetration depth; 3 Effects)

•

PowerCoag (Fast and effective coagulation with increased dissection capabilities; 3 Effects)

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Chapter 1: PRODUCT SPECIFICATIONs

ESG-400 Bipolar Cut: •

BipolarCut (All bipolar cutting procedures of tissue structures; 3 Effects)

•

SalineCut (Cutting in conductive fluid; 3 Effects; only available via UNIVERSAL socket)

•

PK PureCut (Cutting of varying tissue structures; 3 Effects; only available via UNIVERSAL socket)

•

PK SoftCut (Cutting of varying tissue structures; 3 Effects; only available via UNIVERSAL socket)

•

PK LoopCut (Cutting of varying tissue structures, especially fibroid tissue; 3 Effects; only available via UNIVERSAL socket)

•

PK MorceCut (Cutting of varying tissue structures, especially fibroid tissue; 3 Effects; only available via UNIVERSAL socket)

Bipolar Coagulation: •

BiSoftCoag

•

AutoCoag (Coagulation with little sticking and carbonization; 3 Effects)

•

SalineCoag (Coagulation in conductive fluid; 3 Effects; only available via UNIVERSAL socket )

•

HardCoag (Controlled tissue coagulation; 3 Effects)

•

RFCoag (Controlled deep tissue coagulation; with and without RCAP)

•

FineCoag (Coagulation of tissue with little sticking and carbonization; 1 Effect)

•

PK Coag (Coagulation of tissue with little sticking and carbonization; 3 Effects)

•

PK SoftCoag (Coagulation of tissue with little sticking and carbonization; 3 Effects)

•

PK AutoCoag (Controlled tissue coagulation; 1 Effect)

(Coagulation with little sticking and carbonization; 3 Effects)

The modes have preset power levels that may be customized by the user in a defined range.

2-2

Accessories Footswitch Double Pedal (WB50402W): It has a blue pedal that is used to activate the selected coagulation mode and a yellow pedal that is used to activate the selected cutting mode. Footswitch Single Pedal (optional; WB50403W): It has a blue pedal that is used to activate the selected coagulation mode P-Cord (optional; MAJ-814): The P-cord is used to connect a patient plate to the ESG-400.

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ESG-400

3 Limitations (1) Use this product under the supervision of a doctor at a medical facility. (2) Do not use this product in combination with the products other than those designated by Olympus. (3) This product shoul be used, transported or stored in the following environment. Operation environment

Transportation and storage environment

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Temperature

+ 10…+ 40°C

Relative humidity

30…85%, non-condensing

Atmospheric pressure

70…106 kPa

Temperature

- 25…+ 60°C

Relative humidity

10…85%, non-condensing

Atmospheric pressure

50…106 kPa

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ESG-400

4 Specifications 4-1

ELECTROSURGICAL GENERATOR ESG-400 (REF: WB91051W) Power supply

Voltage range

100…120 V~ / 220…240 V~

Frequency

50 / 60 Hz

Maximum input power

1500 VA

Power fuse

10 A (only FST-series from Schurter)

Power connection line

IEC 60320-1 / C13 Maximum length: 4.5 m

Terminal for equalization Size, weight packaging

Classification

potential Yes

and Width x Depth x Height

370 × 465 × 156 mm

Volume

25752 cm³

Weight of generator

12.5 kg

Weight of packaging

2.3 kg

Type of packaging

Cardboard and expanded polypropylene material

Protection class according CF, Class I to IEC 60601-1 Classification according to IIb MDD 93/42/EEC

Output

High frequency functions

Monopolar / Bipolar

High frequency

430 kHz ±20%

Maximum high frequency 320 W power All modes

25% duty cycle (e.g. 10 s activated / 30 deactivated)

RFCoag (with or without 100% duty cycle RCAP)

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ESG-400 Sockets

MONOPOLAR 1

3-pin (∅ 4 mm), Valleylab standard; coaxial (∅ 8 mm), Bovie standard

MONOPOLAR 2

3-pin (∅ 4 mm), Valleylab standard; coaxial (∅ 5 / 9 mm), Erbe standard

BIPOLAR

2-pin (∅ 4 mm, pin spacing 28.8 mm), Valleylab standard; coaxial (∅inner 8 mm, ∅outer 4 mm), Erbe standard

UNIVERSAL

7-pin, Olympus standard

Neutral electrode

Single or split, 10 mm plug

Contact quality Allowable resistance range 10...155 Ω ±15 Ω monitor (CQM) for split type neutral electrodes Allowable resistance range < 10 Ω ±5 Ω for non-split type neutral electrodes

4-2

Power cords (4.5 m angled plug) Power cords

WA95621A

Many European countries Type E/F

WA95622A

USA, Canada countries

and

other

and

other

Type B WA95623A

United Kingdom countries Type G

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ESG-400

4-3

Footswitch (REF: WB50402W, double pedal) Classification

Size, weight packaging

4-4

and Width x Depth x Height

350 × 185 × 65 mm

Weight of footswitch

1.9 kg

Length of cord

Weight of packaging

0.5 kg

Type of packaging

Cardboard material

Footswitch (REF: WB50403W, single pedal, optional) Classification

Size, weight packaging

4-5

Protection class according IPX8 (except the plug section) to IEC 60529

Protection class according IPX8 (except the plug section) to IEC 60529 and Width x Depth x Height

175 × 185 × 50 mm

Weight of footswitch

1.6 kg

Length of cord

Weight of packaging

0.5 kg

Type of packaging

Cardboard material

Neutral electrode cable “P-cord” (REF: MAJ-814, optional) Size

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Weight

0.14 kg

Length of cord

3.1 m

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ESG-400

4-6

Communication cable 0.25 m (REF: MAJ-1871, optional) Size

4-7

0.05 kg

Length of cord

0.25 m

Communication cable 10 m (REF: MAJ-1872, optional) Size

4-8

Weight

0.5 kg

Length of cord

10 m

Adapter for UHI-2/3 (REF: MAJ-1873, optional) Size

Width x Depth x Height

100 × 77 × 42 mm

Weight

0.35 kg

Compatible cables

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MAJ-1871, MAJ-1872

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Chapter 1: PRODUCT SPECIFICATIONs

ESG-400

5 Name and Function of each part 5-1 5-1-1

Symbols and descriptions Safety related symbols

Output insulated from earth (connection for neutral electrode)

Caution, read instructions Refer to instructions

Defibrillation proof type CF applied part (cardiac application)

Type plate Date of manufacture

CE marking

Non-ionizing electromagnetic radiation

Waste electrical and electronic equipment

cTUVus marking

Manufacturer

Fuse rating

Potential equalization terminal

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ESG-400

5-1-2

Front panel

Power on / off

Neutral electrode – non-split type

Neutral electrode – split type

Select procedure

Footswitch

BIPOLAR socket

MONOPOLAR 1 socket

UNIVERSAL socket

MONOPOLAR 2 socket

5-1-3

Touch screen

Double footswitch

Single footswitch

Autostart

Plus

Minus

Return

Cancel

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Chapter 1: PRODUCT SPECIFICATIONs

ESG-400

Save procedure

Delete procedure

Languages

Touch tone on

Touch tone off

Software version

Safety test

Service

Volume

Brightness

Select procedure (in title line)

Menu (in title line)

Toggle

Numeric

Alphabetic

Uppercase / lowercase

Backspace

Caution

Communication indicator

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Chapter 1: PRODUCT SPECIFICATIONs

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