UES-40 SurgMaster ELECTROSURGICAL UNIT Instructions June 2011

Important Precautions Critical for Safety (Be sure to read this information before use.)

Important Precautions Critical for Safety (Be sure to read this information before use.) •

Before performing electrosurgical therapy, thoroughly study the properties, purposes, effects and possible risks (the nature, extent and probability) of the planned treatment and any alternative therapeutic method that can be performed. Perform therapy only when its benefits outweigh its risks. During endoscopic treatment, continue to evaluate the potential benefits and risks, and stop the treatment if the risks become greater than the possible benefit to the patient.

•

The flow or discharge of high-frequency current could injure the patient, operator and/or assistant. When handling this product, also pay close attention to all “DANGER”, “WARNING” and “CAUTION” statements given in this manual.

•

Make sufficient preparations for treatment of unexpected emergencies such as burns, bleeding and puncturing before using this product.

ELECTROSURGICAL UNIT UES-40

i

Important Precautions Critical for Safety (Be sure to read this information before use.)

ii

ELECTROSURGICAL UNIT UES-40

Contents

Contents Important Precautions Critical for Safety (Be sure to read this information before use.)...

i

Labels and Symbols ...

1

Important Information - Please Read Before Use...

3

Intended use ...

3

Instruction manual ...

3

User qualifications ...

3

Instrument compatibility ...

4

Repair and modification ...

4

Signal words ...

4

Dangers, warnings and cautions ...

5

Chapter 1

Checking the Package Contents...

12

Chapter 2

Nomenclature and Functions ...

14

2.1

Front panel...

14

2.2

Rear panel ...

18

2.3

Foot switch for UES-40 (MAJ-1258) ...

20

2.4

Bipolar foot switch for UES-40 (MAJ-1259) ...

21

2.5

A adapter 2 (MAJ-619)...

22

Installation and Connection ...

23

3.1

Installation of equipment ...

23

3.2

Connection to an AC mains power supply ...

24

3.3

Connection of foot switch MAJ-1258 ...

25

3.4

Connection of foot switch MAJ-1259 ...

26

3.5

Connection of the patient plate (for monopolar treatment) ...

27

3.6

Connection of the hand piece (for monopolar treatment) ...

30

3.7

Connection of the A cord (for monopolar treatment)...

31

3.8

Connection of the A adapter 2 (MAJ-619) ...

32

3.9

Connection of the bipolar electrode and bipolar cord (for bipolar treatment) ...

33

3.10 Connection of the saline electrode and saline cord (for saline treatment)...

35

Chapter 3

ELECTROSURGICAL UNIT UES-40

iii

Contents

Chapter 4

Inspection...

36

4.1

Inspecting the connections ...

36

4.2

Inspection of the UES-40 ...

37

4.3

Inspection of the foot switch operation...

38

4.4

Bipolar setting ...

39

4.5

Monopolar setting ...

40

4.6

Saline setting (when saline output mode is used)...

41

4.7

Inspection of warning function ...

44

Operation...

46

5.1

Turn the power ON ...

47

5.2

Automatic memory mode ...

47

5.3

Preset mode...

48

5.4

Selection of saline mode ...

51

5.5

Selection of foot switch output ...

52

5.6

Selection of cut mode ...

53

5.7

Selection of coagulation mode ...

55

5.8

Setting output ...

58

5.9

Maximum output ...

59

5.10 Electrosurgery ...

60

5.11 Automatic exhaust ...

62

5.12 Procedure after use ...

63

Chapter 5

Chapter 6

Care, Storage and Disposal ...

65

6.1

Care ...

65

6.2

Storage ...

66

6.3

Care of A adapter 2...

66

6.4

Storage of A adapter 2 ...

67

6.5

Disposal ...

67

Troubleshooting ...

68

7.1

Troubleshooting guide ...

68

7.2

Alarm functions ...

75

7.3

Returning the UES-40 for repair...

79

Chapter 7

iv

ELECTROSURGICAL UNIT UES-40

Contents

Appendix ...

80

Construction ...

80

Output mode chart ...

82

System chart ...

83

Operating and storage environments...

87

Specifications ...

88

EMC information ...

100

ELECTROSURGICAL UNIT UES-40

v

Contents

vi

ELECTROSURGICAL UNIT UES-40

Labels and Symbols

Labels and Symbols Safety-related labels and symbols are attached to the instrument at the location shown below. If labels or symbols are missing or illegible, contact Olympus.

 Rear side

Serial number

Electrical rating plate Product name and rated voltage are displayed.

ELECTROSURGICAL UNIT UES-40

1

Labels and Symbols

Electrical rating plate

  



 Back cover of this instruction manual Manufacturer

Authorized representative in the European Community

2

ELECTROSURGICAL UNIT UES-40

Important Information - Please Read Before Use

Important Information - Please Read Before Use Intended use This instrument has been designed for use in a medical facility under the supervision of a trained physician. It has been designed for general (open) and endoscopic surgery including urology, gynecology, respiratory and gastroenterology in conjunction with Olympus designed electrosurgical accessories, endoscopes (fiberscopes, videoscopes and rigid scopes) applicable for electrosurgery (cutting and coagulation), light sources and other ancillary equipment. Do not use this instrument for any purpose other than its intended use.

Instruction manual This instruction manual contains essential information on using this instrument safely and effectively. Before use, thoroughly review this manual and the manuals of all equipment which will be used during the procedure and use the equipment as instructed. Keep this and all related instruction manuals in a safe, accessible location. If you have any questions or comments about any information in this manual, please contact Olympus.

 Terms used in this manual Wall mains outlet An electrical outlet that has a terminal used exclusively for grounding.

User qualifications The operator of this instrument must be a physician or medical personnel under the supervision of a physician and must have received sufficient training in electrosurgical procedures. This manual, therefore, does not explain or discuss endoscopic or electrosurgical procedures.

ELECTROSURGICAL UNIT UES-40

3

Important Information - Please Read Before Use

Instrument compatibility Refer to the “System chart” in the Appendix to confirm that this instrument is compatible with the ancillary equipment being used. Using incompatible equipment can result in patient injury and/or equipment damage. This instrument complies with the EMC standard for medical electrical equipment; edition 2 (IEC 60601-1-2: 2001). However, when connecting to an instrument that complies with the EMC standard for medical electrical equipment; edition 1 (IEC 60601-1-2: 1993), the whole system complies with edition 1.

Repair and modification This instrument does not contain any user-serviceable parts. Do not disassemble, modify, or attempt to repair it; patient or user injury and/or equipment damage can result. Some problems that appear to be malfunctions may be correctable by referring to Chapter 7, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 7, contact Olympus.

Signal words The following signal words are used throughout this manual:

Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

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.

Indicates additional helpful information.

4

ELECTROSURGICAL UNIT UES-40

Important Information - Please Read Before Use

Dangers, warnings and cautions Follow the dangers, warning and cautions given below when handling this instrument. This information is to be supplemented by the dangers, warnings and cautions given in each chapter.

•

The high-frequency (HF) equipment, when applied to a patient with a pacemaker implanted, may cause malfunction or failure of the pacemaker, seriously affecting the patient. Before proceeding, confirm with a cardiologist and the manufacturer of the pacemaker that it is safe to do so.

•

To prevent shock hazards, never apply the UES-40 to the heart in combination with type B or type BF applied part.

•

When using the UES-40 on or in the vicinity of the heart, be sure to use it with the minimum necessary output. Spark discharge during operation may affect the heart.

•

The UES-40 is not explosion-proof construction. Never install or operate it where flammable gases are present.

•

Never install or operate the UES-40 where:  the concentration of oxygen is high.  oxidizing agents (such as nitrous oxide [N2O]) are present in the atmosphere.  flammable anesthetics and/or gases are present in the atmosphere.

•

If absorbent cotton or gauze is used during the procedure, it can be ignited by a spark generated in the normal operation of the equipment.

•

Prepare a spare UES-40 as a backup to ensure that the procedure can be completed without complication in case of a malfunction. If therapy is possible using non-electrosurgical equipment, it is also acceptable to prepare such equipment as a backup.

•

Always have a defibrillator ready in case of a cardiac emergency. During operation of the defibrillator, remove the endoscope from the patient.

•

Never attach the patient plate in the vicinity of a metal implant. The tissue in the vicinity of the metal implant may be burned.

ELECTROSURGICAL UNIT UES-40

5

Important Information - Please Read Before Use

6

•

Be sure that this instrument is not used adjacent to or stacked with other equipment (other than the components of this instrument or system) to avoid electromagnetic interference.

•

Electromagnetic may occur to this instrument near equipment marked with the following symbol or other portable and mobile RF communications equipment such as cellular phones. If radio interference occurs, mitigation measures may be necessary, such as reorienting or relocating this instrument or shielding the location.

•

Keep the UES-40 and ancillary cords (A cord, bipolar cord, patient plate cord, hand piece cord) as far away as possible from other electromedical equipment and cords. If placed too close, high-frequency signals or spark discharge noise from the UES-40 may interfere with the operation of other equipment.

•

To prevent patient burns, the UES-40 and ancillary cords (A cord, bipolar cord, patient plate cord, hand piece cord) should not come in contact with the patient or metal parts of the operating table. Furthermore, the patient should also be kept away from metallic parts of the operating table or other devices.

•

Never loop the cords (A cord, bipolar cord, patient plate cord, hand piece cord) or bundle cords together with cords belonging to other medical equipment. The high-frequency signals or spark discharge noise generated by the UES-40 may interfere with the operation of other medical equipment.

•

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

•

Always use the UES-40 as outlined in this instruction 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 instruction manual.

•

The UES-40 may interfere with electromedical equipment used in conjunction with it. Before use, thoroughly confirm the compatibility of all equipment.

ELECTROSURGICAL UNIT UES-40

Important Information - Please Read Before Use

•

To prevent the risk of electric shock, the housing of the UES-40 must be grounded. Always connect the power cord plug to a properly grounded hospital grade AC receptacle (wall mains outlet) as shown in the figure below. Do not use a 3-pin/2-pin adapter, as it can impair safe operation of the unit. Hospital grade AC receptacle

•

To prevent electric shock, the UES-40 is designed to function with insulated connectors that have Type CF applied parts (A cord, hand piece, patient plate). Therefore, to prevent shock caused by leakage current from other electrical equipment applied to the patient, the connectors should not be grounded.

•

Should any abnormal output be suspected during operation, immediately terminate the use of the equipment and turn OFF the power switch. Otherwise, malfunction of the equipment may cause an unintended increase in output.

•

To prevent operator shock and instrument damage, keep liquids away from all electrical equipment. If liquid gets on or into the UES-40, terminate operation immediately and contact Olympus.

•

To prevent patient burns, the patient’s skin surfaces should not touch each other (e.g. bare arm and side of chest).

•

To prevent patient burns, the operator and assistant should wear protective gloves during the procedure.

•

To prevent patient burns during fiberscopic or videoscopic treatment, the patient’s clothes must be dry.

•

If the intestines contain a flammable gas, replace it with air or a non-flammable gas before performing the operation, to minimize the risk of fire or explosion.

ELECTROSURGICAL UNIT UES-40

7

Important Information - Please Read Before Use

•

During fiberscopic or videoscopic treatment, be sure that the distal end of the endoscope and metallic parts of the accessory do not touch the normal tissue surrounding the target tissue as this may cause severe burns.

•

During fiberscopic or videoscopic treatment, be sure that the distal end of the endoscope or accessory does not contact bridging fluids surrounding the target tissue. Electric current may flow to the surrounding normal tissue via the fluids and cause burns.

•

During fiberscopic or videoscopic treatment, never grasp the target tissue with non-insulated grasping forceps. Non-insulated grasping forceps will disperse the electric current and normal operation may be impeded.

•

To ensure electrical safety, the UES-40 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.

8

•

The UES-40 should only be used under the conditions described in , “Operating environment” in the Appendix. Use under other conditions may impede normal performance and/or result in equipment damage.

•

If the UES-40 is used in conjunction with a non-Olympus electrosurgical unit, keep the electrosurgical accessory away from the target area while the UES-40 is in operation. Do not activate output of both units simultaneously. Patient or operator injury may occur due to the concentration of electric current.

•

When using an electrocardiograph or other physiological monitoring equipment simultaneously with the UES-40 on a patient, any monitoring electrodes should be placed as far away as possible from the electrodes (accessories/hand piece and patient plate) used with the UES-40. If placed too close, high-frequency signals or spark discharge noise from the UES-40 may interfere with the operation of an electrocardiograph or other physiological monitoring equipment. Needle monitoring electrodes should not be used, as they may cause patient burns. Physiological monitoring equipment incorporating high-frequency current limiting devices is recommended.

ELECTROSURGICAL UNIT UES-40

Important Information - Please Read Before Use

•

The open-circuit voltage output characteristics of the UES-40 are shown below. When setting the output 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 operator and/or patient burns. Furthermore, it is recommended that you perform basic experiments before using the UES-40. If the instruction manual for the endoscopic accessory to be used stipulates a rated voltage, the output should be set so that it does not exceed that voltage.

MAXIMUM OUTPUT VOLTAGE (V)

Monopolar (1) PURE, URO (2) BLEND (3) COAG.1 (4) COAG.2 (5) SPRAY

POWER SETTING (W)

MAXIMUM OUTPUT VOLTAGE (V)

Bipolar

(1) PURE (2) SOFT1, SOFT2

POWER SETTING (W)

MAXIMUM OUTPUT VOLTAGE (V)

Bipolar

(3) HARD

SETTING

ELECTROSURGICAL UNIT UES-40

9

Important Information - Please Read Before Use

MAXIMUM OUTPUT VOLTAGE (V)

Saline (1) PURE (2) BLEND (3) COAG.1 (4) COAG.2

POWER SETTING (W)

10

•

Flammable agents used for cleaning and disinfection must be allowed to evaporate before the UES-40 is used. Also ensure that flammable solutions are neither on the patient’s skin nor in the patient’s body cavity when the UES-40 is used.

•

For surgical procedures where the high-frequency current could flow through parts of the body with a relatively small cross-sectional area, use of the bipolar mode may be desirable to avoid accidental coagulation.

•

To prevent patient burns when the UES-40 is used in conjunction with a non-Olympus electrosurgical unit, ensure that each unit is supplied with power from separate electrosurgical units. Also ensure that each unit is supplied with power from separate breakers.

•

During operation, temporarily unused electrodes should be stored in an electrically insulated container. Unused electrodes should never be placed on the patient. Otherwise, it may cause patient and/or operator burns.

•

Studies have shown that smoke generated during electrosurgical procedures can be irritating and potentially harmful to surgical personnel. These studies recommend the use of surgical masks and adequate ventilation of smoke using surgical smoke evacuators or other means.

ELECTROSURGICAL UNIT UES-40

Important Information - Please Read Before Use

 William S. Sawchuk, et al., “Infectious Papillomavirus in the Vapor of Warts Treated With Laser or Electrocoagulation: Detection and Protection”, Journal of American Academy of Dermatology, Vol.21, No.1 (July, 1989): 41 – 49. Yoshifumi Tomita, et al., “Mutagencity of Smoke Condensates Induced by CO2-Laser Irradiation and Electrocauterization”, Mutation Research, Vol.89 (1989): 145 – 149. Evaluation Report No.85 – 126. (National Technical Information Service, 1985): 1 – 28. •

When the patient is moved after the dispersive electrode has been attached, confirm that the dispersive electrode is still in proper contact with the patient. Otherwise, it may cause patient and/or operator burns.

•

This instrument cannot be used with an endoscope equipped with the S cord connector receptacle.

•

If the UES-40 is used with a rigid endoscope and is providing monopolar output, activation of the UES-40 when not in contact with target tissue or in a position to deliver energy to target tissue (fulguration) may cause capacitive coupling.

•

Do not use the UES-40 in a location exposed to strong electromagnetic radiation (microwave or short-wave medical treatment equipment, MRI, radio or mobile phone equipment). These can impair operation of the unit.

•

Always confirm that the unit is safe to use in the system configuration that you have arranged. In general, the unit should be used only with equipment shown in the “System chart” in the Appendix. Using the unit in a configuration that includes equipment not shown in the “System chart” may not only prevent the unit from performing as intended, it can cause patient or operator injury and/or equipment damage. When you intend to use the unit in a configuration that includes equipment other than that shown in the “System chart”, confirm that the unit functions safely in that system configuration before proceeding.

•

Never bring the electrocautery tip in contact with a metallic clip, electrosurgical accessory or retractor. Doing so could cause burns to tissue in the vicinity.

•

To prevent instrument damage, never short-circuit electrodes (accessories, hand piece or patient plate).

•

Repairs should be performed only by Olympus.

ELECTROSURGICAL UNIT UES-40

11

Chapter 1 Checking the Package Contents

Chapter 1 Checking the Package Contents Match all items in the package with the components shown below. Inspect each item for damage. If the instrument is damaged, a component is missing or you have any questions, do not use the instrument; immediately contact Olympus.

Power cord

Electrosurgical unit (UES-40)

Instruction manual

Foot switch for UES-40 (MAJ-1258)

12

ELECTROSURGICAL UNIT UES-40

Chapter 1 Checking the Package Contents

The following Olympus items are optional items which may be purchased separately: •

A cord (A00012A, A00506A, A02915A (MAJ-860), A0335.1, A0336.1, A0358, A0393)

•

Bipolar electrode (A5380, A5382, A5384, A5386, A5388, A5390, A5392, A5394, O5119)

•

Bipolar cord (A00500A, A00504A, A5121.1, A5376, A5377)

•

Bipolar foot switch for UES-40 (MAJ-1259)

•

A adapter 2 (MAJ-619)

•

Interactive cable (MAJ-877)

•

Saline cord (WA00013A)

•

Patient plate (MAJ-897)

•

P cord (MAJ-814)

The following recommended non-Olympus items may also be purchased separately: •

Hand piece (for connection method, refer to Section 3.6, “Connection of the hand piece (for monopolar treatment)”)

•

The patient plate (for compatible patient plates, refer to Section 3.5, “Connection of the patient plate (for monopolar treatment)”)

•

The bipolar electrode (for compatible bipolar electrodes, refer to Section 3.9, “Connection of the bipolar electrode and bipolar cord (for bipolar treatment)”)

•

Bipolar cord (for compatible bipolar cords, refer to Section 3.9, “Connection of the bipolar electrode and bipolar cord (for bipolar treatment)”)

For other equipment combinations, refer to the “System chart” in the Appendix.

•

Place the instruction manual next to the UES-40 or in another easily accessible place.

•

Before using an optional item, thoroughly review and understand the instruction manual provided with that item.

•

Some products may not be available in some regions. Please contact the nearest Olympus office for details.

•

Specifications, design and accessories are subject to change without any notice or obligation on the part of the manufacturer.

ELECTROSURGICAL UNIT UES-40

13