ESG-100 ELECTROSURGICAL UNIT Maintenance Manual Rev 5 May 2015

Olympus ESG-100

Maintenance Manual

Revision history No.

REF No. / Revision No.

Release date

Modifications description

1

WB135742-W10

2008-03-28

First clearance

2

WB135742-W11

2009-01-30

Page 5 subchapter 9.9.1 and 9.9.2 added Page 9-1 sentence “If the electrosurgical unit fails to meet any of the checks, refer to chapter 14 (Troubleshooting) or the unit has to be adjusted according to the service manual (see chapter 10, Adjustment of the electrosurgical unit). If the failure still occurs, contact the manufacturer.” added and partly modified Page 9-1 “2000 Ω” added under “Recommended test equipment and accessories” Page 9-6 “open earth” added in procedure step 5) and 6) as an additional explanation for “SFC” Page 9-10 subchapter 9.9 modified: “2000 Ω” added under “Equipment required”; chapter headline “9.9.1 Output power at rated load” added, Page 9-11 subchapter “9.9.2 Output power at nonrated load” added Page 9-14 “W” [Watt] (colomn “Requirement”) and “Ω” (colomn “Load resistance”) added under section “Output power” Page 9-14 added test “ForcedCoag 2, 120 W, 2000 Ω load, 32…48 output power range”) under section “Output power” Page 15-1 “2000 Ω” added in column “Remarks” in row “Load resistors” Last page (list of distributors) updated

3

WB135742-W12

2012-03-13

LM-Change WCR-11302

4

WB135742-W13

2012-10-12

Page 1 Picture of ESG-100 added Page 9-7 New procedure during PSC “Checking output waveform […]” added Page 9-8 Table 9.2 “good and bad examples of the output waveform” added Page 9-10 Description updated “For applicable markets” Page 9-11 New Step “Monopolar Cut 3 (Amplitude fluctuation)” added Page 15-1 ESG-Testbox, Oscilloscope and High Voltage Probe added

2015-05-26

Chapter 9-11 Added tolerance (+/-10 %) at Power consumption

W-CR-11830

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Contents 1

Important information 1.1

Intended use

1.2

Maintenance instructions

1.3

User qualification

1.4

Electrosurgical unit compatibility

1.5

Signal words

1.6

Danger, warnings and cautions

2

General description

3

Symbols, definitions and functions 3.1

3.2

3.3

4

5

4

Symbols and descriptions 3.1.1

Front panel

3.1.2

Rear panel

3.1.3

Packaging

Front panel 3.2.1

Buttons / Switches

3.2.2

Indicators

3.2.3

Displays

3.2.4

Connectors

Rear panel

Accessories 4.1

Footswitch

4.2

P-cord

4.3

A-cord

4.4

Peristaltic pump unit AFU-100 and communication cable

Installation 5.1

Installation of equipment

5.2

Connection to an AC mains power supply

5.3

Equipotential bonding

5.4

Connection of footswitch

5.5

Connection to the peristaltic pump unit AFU-100

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6

7

8

9

Commissioning 6.1

Power supply

6.2

Acoustic signals and tone volume adjustments

6.3

Neutral electrode (for monopolar treatment only) 6.3.1

Split type neutral electrode

6.3.2

Non-split neutral electrode

6.3.3

Connection of the neutral electrode

6.4

Connection of instruments

6.5

Mode selection

6.6

Output power setting

6.7

Activation of selected mode

Cleaning, storage and disposal 7.1

Cleaning

7.2

Storage

7.3

Disposal of the unit

Identification of hardware / software version 8.1

Identification of hardware version

8.2

Identification of software version

Periodic safety checks 9.1

Visual inspection of the electrosurgical unit and accessories

9.2

Verifying the contact quality monitor function

9.3

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

9.4

Checking the earth resistance (according to IEC 60601-1 and IEC 62353)

9.5

Checking the earth leakage current (according to IEC 60601-1)

9.6

Checking the patient leakage current (according to IEC 60601-1)

9.7

Checking the current and power consumption and output waveform

9.8

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

9.9

10

Maintenance Manual

9.9.1

Monopolar high frequency leakage current

9.9.2

Bipolar high frequency leakage current

Checking the output power 9.9.1

Output power at rated load

9.9.2

Output power at non-rated load

9.10

Inspection label

9.11

Safety check report

Block diagram

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11

Troubleshooting 11.1

Footswitch operation

11.2

Neutral electrode operation

11.3

Error codes and measures

11.4

Returning the electrosurgical unit for repair

12

Service operation mode

13

System chart

14

Specifications 14.1

Mode characteristics

14.2

Output waveforms (at rated load)

14.3

Output characteristics

14.4

Technical data

15

Jigs, tools and measuring equipment

16

Electromagnetic compatibility (EMC)

6

Olympus ESG-100

16.1

Guidance and manufacturer’s declaration – electromagnetic emissions

16.2

Guidance and manufacturer’s declaration – electromagnetic immunity

16.3

Recommended separation distances between portable and mobile high frequency communication equipment and the electrosurgical unit

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1

Important information

1.1

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

1.2

Maintenance instructions This maintenance manual contains essential information on using and maintaining this electrosurgical unit safely and effectively. Instructions for the operation of this electrosurgical unit 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 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.

1.3

User qualification The user must have received appropriate training in using this electrosurgical unit. 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 authorised representatives of Olympus during installation and commissioning. Federal Law of the USA restricts this device to use by, or on the order of, a physician.

1.4

Electrosurgical unit compatibility Refer to chapter 13 (System chart) to confirm that this electrosurgical unit is compatible with the ancillary equipment being used. Using incompatible equipment can result in user injury and / or equipment damage.

1.5

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.

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Danger, warnings and cautions High frequency leakage current or spark discharge may cause user burns. Follow the dangers, warnings and cautions given below when handling and maintaining 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

Always use the electrosurgical unit as outlined in this maintenance manual. Improper use will not only impede functions and prevent optimum performance, but may cause equipment damage. Before each use, always inspect the equipment as outlined in this maintenance manual.

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 unit complies with the electromagnetic compatibility (EMC) standard. Nevertheless, when the electrosurgical unit is active it may disturb neighboring electronic equipment. Follow the instructions in chapter 16 (Electromagnetic compatibility) 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 unit should only be used under the conditions as described in chapter 14.4 (Technical data). Use under other conditions may impede normal performance and / or result in equipment damage.

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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 unit shall only be used with compatible accessories. When connecting accessories (cords, electrodes, instruments) avoid output settings where the maximum output voltage of the electrosurgical unit may exceed the rated accessory voltage (refer to chapters 14.1, Mode characteristics, 14.3 Output characteristics, and the instructions for use of the accessory). Refer to chapter 14.4 (Technical data) for a list of compatible neutral electrodes. 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. Set the power levels to the lowest setting before testing an accessory.

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 authorised technicians.

Burns WARNING

User

The maximum output voltage characteristics of the electrosurgical unit are shown in the diagrams in chapter 14.3 (Output characteristics). 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 burns. 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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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 anaesthetics, 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 maintained. 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 authorised 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 maintaining according to chapter 7.1 (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. 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.

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Maintenance Manual

General description The ESG-100 electrosurgical unit enables the user to perform common monopolar and bipolar applications. Both can be operated in cutting and coagulation modes. The electrosurgical unit is equipped with a user friendly display that allows the user to select from a list of optimized modes. All settings are saved automatically and are at the user’s disposition when switching on the electrosurgical unit the next time or when the user changes the modes during a procedure. The electrosurgical unit is equipped with a high voltage power supply which allows fast control of the output resulting in safely controlled tissue effects and protection against over- and under-dosage. In addition, the integrated high power cut support (HPCS) is a precondition for optimized cutting procedures without initial delay. Another feature of the electrosurgical unit is the fast spark monitor (FSM). This technology measures the spark intensity in intervals of a few milliseconds when cutting tissue. The fast spark monitor ensures the application of output powers that are as low as possible and as much as necessary to achieve well defined tissue effects. Moreover, the contact quality monitor (CQM) analyses continuously the contact resistance of the neutral electrode, ensuring a safe application and minimizing the risk of thermal injuries to the patient. The contact quality monitor status is continuously displayed by visual indicators. Finally, the leakage protection sensor (LPS) automatically monitors the high frequency leakage current through the patient and produces a visual and acoustic signal if the current is too high.

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3

Symbols, definitions and functions

3.1

Symbols and descriptions

3.1.1

Front panel

Power on / off

Caution

Toggle between modes Defibrillation proof type CF applied part (cardiac application) Up

Down

Bipolar cutting

Bipolar coagulation

Monopolar cutting

Monopolar coagulation Output insulated from earth (connection for neutral electrode) Footswitch assignment

Neutral electrode – non-split type

Neutral electrode – split type

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Olympus ESG-100

Rear panel Manufacturer Date of manufacture Serial number Reference number Indication of the direction of higher volume Loudspeaker Footswitch connection Interface for pump connection Operating instructions Waste electrical and electronic equipment Fuse Non-ionizing electromagnetic radiation Product carries the CE mark

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Maintenance Manual

Packaging Keep away from rain Fragile; handle with care This way up Temperature storage

limit

during

transport

and

Stacking limit by number (including lowest box) Atmospheric pressure transport and storage

limitation

during

Relative humidity limitation during transport and storage Quantity

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Olympus ESG-100

Front panel

Level display (21)

Up / down button (6 / 5)

Error indicator (8)

Mode display (22)

Power switch (0)

Toggle button (7)

Bipolar cut mode indicator (9)

Activation indicator bipolar cut (13)

Contact quality monitor indicator for split neutral electrode (20)

Footswitch assignment to bipolar connector indicator (17)

Neutral electrode connector (25)

Bipolar cut select button (1)

Bipolar connector (23) Activation indicator bipolar coagulation (14) Bipolar coagulation mode indicator (10) Bipolar coagulation select button (2)

Contact quality monitor indicator for non-split neutral electrode (19) Monopolar coagulation select button (4) Monopolar coagulation mode indicator (12) Activation indicator monopolar coagulation (16) Footswitch assignment to monopolar connector indicator (18) Monopolar connector (24) Activation indicator monopolar cut (15) Monopolar cut select button (3) Monopolar cut mode indicator (11)

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3.2.1

Maintenance Manual

Buttons / Switches 0

Power switch This switch turns on and off the electrosurgical unit.

1

Bipolar cut select button This button is used for the selection of a bipolar cutting mode. The level display (21) shows the selected power level. The mode display (22) shows the selected mode.

2

Bipolar coagulation select button This button is used for the selection of a bipolar coagulation mode. The level display (21) shows the selected power level. The mode display (22) shows the selected mode.

3

Monopolar cut select button This button is used for the selection of a monopolar cutting mode. The level display (21) shows the selected power level. The mode display (22) shows the selected mode.

4

Monopolar coagulation select button This button is used for the selection of a monopolar coagulation mode. The level display (21) shows the selected power level. The mode display (22) shows the selected mode.

6/5

Up / down button These buttons increase / decrease the value displayed at level display (21) during normal operation.

7

Toggle button This button switches to the next mode shown in the mode display (22).

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Olympus ESG-100

Indicators 8

Error indicator This indicator illuminates red if any error occurs.

9

Bipolar cut mode indicator This indicator signals a bipolar cutting selection.

10

Bipolar coagulation mode indicator This indicator signals a bipolar coagulation selection.

11

Monopolar cut mode indicator This indicator signals a monopolar cutting selection.

12

Monopolar coagulation mode indicator This indicator signals a monopolar coagulation selection.

13

Activation indicator bipolar cut This indicator signals a bipolar cutting activation.

14

Activation indicator bipolar coagulation This indicator signals a bipolar coagulation activation.

15

Activation indicator monopolar cut This indicator signals a monopolar cutting activation.

16

Activation indicator monopolar coagulation This indicator signals a monopolar coagulation activation.

17

Footswitch assignment to bipolar connector indicator This indicator signals the footswitch assignment to the bipolar connector. When a bipolar cutting or coagulation mode is selected this indicator illuminates and both modes can be activated by the footswitch.

18

Footswitch assignment to monopolar connector indicator This indicator signals the footswitch assignment to monopolar connector. When a monopolar cutting or coagulation mode is selected this indicator illuminates and both modes can be activated by the footswitch.

19

Contact quality monitor indicator for non-split neutral electrode This indicator illuminates green if a non-split neutral electrode is connected.

20

Contact quality monitor indicator for split neutral electrode This indicator illuminates green if a split neutral electrode is connected and the contact resistance is within an acceptable range. The indicator illuminates red if the split neutral electrode is not connected or applied properly (e.g. bad contact quality) or no neutral electrode is connected (in both cases the activation of monopolar output is disabled).

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3.2.3

Maintenance Manual

Displays 21

22

Level display This display shows the currently selected power level. 1…120

Power level

Err

Error notice

InF

Information notice

Mode display This display shows the currently selected mode during normal operation. Cut

Cutting mode

PulseCut

Pulsed cutting mode

SoftCoag

Soft coagulation mode

ForcedCoag

Forced coagulation mode

RFCoag

Controlled tissue coagulation with acoustic resistance feedback (radiofrequency coagulation)

RFCoag + RCAP

Deep tissue coagulation with resistance controlled automatic power (radiofrequency coagulation)

Mid.Ped. -> Toggle

Middle pedal of the footswitch is functioning as a toggle pedal if the peristaltic pump unit is disconnected

Mid.Ped. -> Pump

Middle pedal of the footswitch is activating the pump flow with connected peristaltic pump unit

Error: No.

Error notice and related error number

Text / No.

Information notice with related text or number

NOTE

3.2.4

The mode display messages may depend on the language setting of the electrosurgical unit.

Connectors 23

Bipolar connector This terminal connects the plug of the bipolar applicator.

24

Monopolar connector This terminal connects the plug of the monopolar applicator.

25

Neutral electrode connector This terminal connects the plug of the neutral electrode.

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Olympus ESG-100

Rear panel Volume control (31)

Equipotential bonding connector (28)

Type plate (30)

Communication port peristaltic pump unit (27) Footswitch connector (26)

3–8

Mains connector with integrated fuses (29)

26

Footswitch connector This terminal connects the footswitch with the electrosurgical unit, so that cutting and coagulation modes can be activated by the footswitch.

27

Communication port for peristaltic pump unit AFU-100 This terminal is used for the communication between the electrosurgical unit and the peristaltic pump unit.

28

Equipotential bonding connector This terminal is used for potential equalization.

29

Mains connector with integrated fuses This terminal serves as a connection to the mains power supply.

30

Type plate The type plate contains specific information about the electrosurgical unit regarding type of device, reference number (REF), line voltage range, output power classification, serial number and the registered office of the manufacturer.

31

Volume control This knob is used for adjusting the output volume.

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4

Accessories

4.1

Footswitch

Cut pedal (32)

Middle pedal (34)

Coagulation pedal (33)

Footswitch plug (35)

32

Cut pedal (yellow color) This pedal is used to activate the selected cutting mode.

33

Coagulation pedal (blue color) This pedal is used to activate the selected coagulation mode.

34

Middle pedal This pedal switches between the modes (see the following explanation) or activates the optional peristaltic pump unit (see chapter 4.4, Peristaltic pump unit AFU-100 and communication cable).

35

Footswitch plug Connects the footswitch with the electrosurgical unit on the rear panel.

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The footswitch middle pedal (34) may have three different functions: 1)

If the peristaltic pump unit is connected and switched on, the footswitch middle pedal (34) activates the pump flow.

2)

If there is no communication of the electrosurgical unit with the pump, the user has the possibility to choose between two functionalities:

2a) The user toggles between the modes as it is done by the toggle button (7) at the front panel (see fig. 4.1). The change will be indicated by a beep tone. This is the default setting. Example: A bipolar coagulation mode is preset (e.g. SoftCoag). By pressing the footswitch middle pedal (34) the user toggles between the bipolar modes (e.g. RFCoag -> RFCoag + RCAP -> SoftCoag). 2b) The user changes either between monopolar cut and monopolar coagulation or between bipolar cut and bipolar coagulation mode without using one of the select buttons (1, 2, 3, 4) at the front panel (see fig. 4.2). The change will be indicated by a beep tone. Example: A monopolar cut mode is preset (e.g. Cut 1). By pressing the footswitch middle pedal (34) the user changes to a monopolar coagulation mode (e.g. ForcedCoag 1). The last used coagulation mode will be called. To use the function 2b), change the footswitch function in the service menu as described in chapter 12 (Service operation mode).

SoftCoag

Monopolar cut

Monopolar coagulation

Bipolar cut

Bipolar coagulation

RFCoag RFCoag + RCAP Fig. 4.1: Example of toggling between bipolar modes

4.2

Fig. 4.2: Example of toggling between cut and coagulation modes

P-cord The P-cord (Olympus REF: MAJ-814) is a separate accessory. Lever-locking arm (38)

Plug on the unit side (36)

Clamp (37)

4–2

36

Plug on the unit side This plug connects the P-cord to the electrosurgical unit.

37

Clamp This clamp connects the neutral electrode to the P-cord.

38

Lever-locking arm This arm secures the connector of the neutral electrode with the clamp. WB135742-W14