UES-30 ELECTROSURGICAL UNIT Instructions April 2005

HHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHH ©1999 OLYMPUS MEDICAL SYSTEMS CORP. All rights reserved. No part of this publication may be reproduced or distributed without the express written permission of OLYMPUS MEDICAL SYSTEMS CORP. OLYMPUS is a registered trademark of OLYMPUS CORPORATION.

HHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHH

Manufactured by 2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507, Japan Fax: (0426)46-2429 Telephone: (0426)42-2111

Distributed by Two Corporate Center Drive, PO Box 9058 Melville, N.Y. 11747-9058, U.S.A. Fax: (631)844-5442 Telephone: (631)844-5000

One Corporate Drive, Orangeburg, N.Y. 10962, U.S.A. Fax: (845)398-9444 Telephone: (845)398-9400

6100 Blue Lagoon Drive, Suite 390 Miami, FL 33126-2087, U.S.A. Fax: (305)261-4421 Telephone: (305)266-2332

(Premises/Goods delivery) Wendenstrasse 14-18, 20097 Hamburg, Germany (Letters) Postfach 10 49 08, 20034 Hamburg, Germany Telephone: (040)237730

KeyMed House, Stock Road, Southend-on-Sea, Essex SS2 5QH, United Kingdom Fax: (01702)465677 Telephone: (01702)616333

117071, Moscow, Malaya Kaluzhskaya 19, bld. 1, fl.2, Russia Fax: (095)958-2277 Telephone: (095)958-2245

Room 1406, E Tower, GongYuan No.6 Royal Palace, No.6 GongYuanXiJie, Jian Guo Men Nei, DongCheng District, Beijing, 100005, China Fax: (10)6518-0865 Telephone: (10)6518-8080

8F, Hyundai Marines Bldg., 646-1, Yeoksam-Dong, Kangnam-Gu, Seoul 135-080 Korea Fax: (02)6255-3499 Telephone: (02)1544-3200

491B, River Valley Road #12-01/04, Valley Point Office Tower, Singapore 248373 Fax: 6834-2438 Telephone: 6834-0010

31 Gilby Road, Mount Waverley, VIC., 3149, Australia Fax: (03)9543-1350 Telephone: (03)9265-5400

GC5269 08

Printed in Japan 20050415 :0000

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.) S The flow or discharge of high-frequency current may damage the patient, operator and/or assistants. When handling this product, be sure to observe information given under “DANGER”, ”WARNING” and “CAUTION” in this manual. S Make sufficient preparations for treatment of unexpected emergencies such as burns, bleeding and puncturing before using this product.

ELECTROSURGICAL UNIT UES-30

i

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

ii

ELECTROSURGICAL UNIT UES-30

Contents

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

1

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

Checking the Package Contents...

12

Nomenclature and Functions...

14

2.1

Symbols and Descriptions...

14

2.2

Front Panel...

18

2.3

Rear Panel...

23

2.4

Foot Switch (MH-551)...

25

2.5

S-Cord (MH-470)...

26

2.6

Hand Switch (MH-468)...

27

2.7

A Adapter 2 (MAJ-619)...

28

2.8

A Adapter 3 (MAJ-620)...

28

Installation and Connection...

29

3.1

Installation of Equipment...

29

3.2

Connection to an AC Mains Power Supply...

30

3.3

Connection of the Foot Switch (For Bipolar Treatment or When Using A

1.1

Chapter 2

Chapter 3

Cord for Monopolar Treatment)...

31

3.4

Connection of the Patient Plate (For Monopolar Treatment)...

32

3.5

Connection of the S-Cord (When Using a Fiberscope or Videoscope Equipped With an S-Cord Connector Mount)...

35

3.6

Connection of the Hand Piece (For Monopolar Treatment)...

36

3.7

Connection of the Hand Switch (For Monopolar Treatment With A Cord) ...

ELECTROSURGICAL UNIT UES-30

37

iii

Contents

3.8

Connection of the A Cord (For Monopolar Treatment)...

38

3.9

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

39

3.10 Connection of the A Adapter 3 (MAJ-620)...

40

3.11 Connection of the Bipolar Electrode and Bipolar Cord (For Bipolar Treatment)...

42

3.12 Connection of the Aeration Unit...

43

Chapter 4

Inspection...

45

4.1

Inspecting the Connections...

45

4.2

Inspection of the UES-30 and the FootSwitch...

46

Operation...

54

5.1

Turn the Power ON...

54

5.2

Pre-Set Mode...

55

5.3

Selection of Output Mode...

56

5.4

Selection of Cut Mode...

57

5.5

Selection of Coagulation Mode...

58

5.6

Setting Output...

60

5.7

Electrosurgery...

62

5.8

Stand-By Mode...

64

5.9

Procedure After Use...

65

Care, Storage and Disposal...

67

6.1

General Policy...

67

6.2

Precautions...

68

6.3

Required Reprocessing Equipment...

69

6.4

Cleaning of UES-30 and Foot Switch...

71

6.5

Storage of UES-30 and Foot Switch...

72

6.6

Cleaning Prior to Sterilization of Hand Switch...

72

6.7

Sterilization of Hand Switch...

74

6.8

Storage of Hand Switch...

74

6.9

A Adapter 2 and A Adapter 3 Maintenance...

75

6.10 Storage of A Adapter 2 and A Adapter 3...

75

6.11 Disposal...

75

Chapter 5

Chapter 6

Chapter 7

iv

Troubleshooting...

76

7.1

Troubleshooting Guide...

77

7.2

Alarm Functions...

80

7.3

Returning the UES-30 for Repair...

85

ELECTROSURGICAL UNIT UES-30

Contents

Appendix...

87

Construction...

87

System Chart...

88

Operating Environment...

92

Specifications...

93

ELECTROSURGICAL UNIT UES-30

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Contents

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ELECTROSURGICAL UNIT UES-30

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.

CE Label Crossed-out wheeled bin’ symbol

Electrical Rating Plate Product name, rated voltage, and serial number are displayed.

ELECTROSURGICAL UNIT UES-30

1

Labels and Symbols

Electrical Rating Plate

ELECTROSURGICAL UNIT MODEL INPUT

MONO : BI : 350kHz

UES-30 230V∼ 6A 50/60Hz 300W/300Ω 120W/300Ω INT.10S/30S

SN OLYMPUS MEDICAL SYSTEMS CORP. MADE IN JAPAN

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ELECTROSURGICAL UNIT UES-30

Important Information--Please Read Before Use

Important Information–Please Read Before Use Intended Use This instrument has been designed to be used with Olympus Electrosurgical Accessories, endoscope (fiberscope, videoscope or rigid scope) applicable to electrosurgery, Light Source and other ancillary equipment for general and endoscopic electrosurgery (cutting and coagulate). 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 instruments 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-30

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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 or equipment damage.

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 not 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: 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

4

Indicates additional helpful information.

ELECTROSURGICAL UNIT UES-30

Important Information--Please Read Before Use

Dangers, Warnings and Cautions Follow the dangers, warning and cautions described below when handling this instrument. This information is supplemented by the dangers, warnings and cautions described in each chapter. DANGER

S The HF equipment, when applied to a patient with a pacemaker implanted, may cause malfunctioning or failure of the pacemaker, seriously affecting the patient. Always confirm that it is safe to proceed with a cardiologist or the manufacturer of the pacemaker before proceeding. S To prevent shock hazards, never apply the UES-30 to the heart in combination with type B or type BF equipment. S When using the UES-30 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. S The UES-30 is not explosion-proof. Never install or operate it where flammable gases are present.

WARNING

S Always use the S-CORD when fiberscopic or videoscopic treatment is performed with an endoscope equipped with the S-CORD Connector Mount. When using an endoscope without the S-CORD Connector Mount, refer to the instruction manual and confirm that the electrosurgery is feasible with this endoscope. If the UES-30 is used in conjunction with an endoscope that is not feasible with the electrosurgery, a burn to the patient, the operator or the assistant may occur. S Never install or operate the UES-30 where: -- the concentration of oxygen is high. -- oxidizing agents (such as nitrous oxide N2O) are present in the atmosphere. -- flammable anesthetics are present in the atmosphere. S Prepare a spare UES-30 as a backup to ensure that the procedure can be completed without complication in case of a malfunction. S Always have a defibrillator ready in case of a cardiac emergency. During operation of the defibrillator, remove the endoscope from the patient.

ELECTROSURGICAL UNIT UES-30

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Important Information--Please Read Before Use

S Never attach the Patient Plate in the vicinity of a metal implant. The tissue in the vicinity of the metal implant may be burned. S Keep the UES-30 and ancillary cords (A Cord, Bipolar Cord, Patient Plate Cord, Hand Switch Cord, Hand Piece Cord, S-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-30 may interfere with the operation of other equipment. S To prevent patient burns, the UES-30 and ancillary cords (A Cord, Bipolar Cord, Patient Plate Cord, Hand Switch Cord, Hand Piece Cord, S-Cord) should not come in contact with the patient or metal parts of the operating table. Furthermore, patients should also keep away from metallic parts of the operating table or other devices. S Never loop the cords (A Cord, Bipolar Cord, Patient Plate Cord, Hand Switch Cord, Hand Piece Cord, S-Cord) or bundle cords together with cords belonging to other medical equipment. The high frequency signals or spark discharge noise generated by the UES-30 may interfere with the operation of other medical equipment. S The UES-30 is intended for use in medical facilities under the supervision of a trained physician. Do not use it under any other conditions. S Always use the UES-30 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. S The UES-30 may interfere with electromedical equipment used in conjunction with it. Before use, thoroughly confirm the compatibility all the equipment. S To prevent the risk of electric shock, the housing of the UES-30 must be grounded. Always connect the Power Cord plug to a properly grounded hospital grade AC receptacle (wall mains outlet).

6

ELECTROSURGICAL UNIT UES-30

Important Information--Please Read Before Use

Hospital Grade AC Receptacle

S To prevent electric shock, the UES-30 is designed to function with insulated connectors that have Type CF electromedical equipment classifications (A Cord, Hand Switch, Hand Piece, Patient Plate, S-Cord). Therefore, to prevent shock caused by leakage current from other electrical equipment applied to the patient, the connectors should not be grounded. S Should any abnormal output be suspected during operation, immediately terminate the use of the equipment and turn OFF the Power Switch. S To prevent operator shock and instrument damage, keep liquids away from all electrical equipment. If liquid gets on or into the UES-30, terminate operation immediately and contact Olympus. S To prevent patient burns, the patient’s skin surfaces should not touch each other (e.g. bare arm and side of chest). S To prevent patient burns, the operator and assistant should wear rubber gloves during operation. S To prevent patient burns during fiberscopic or videoscopic treatment, the patient’s clothes must be dry. S If the intestines contain a flammable gas, replace it this gas with air or a non-flammable gas before performing the operation, to minimize the risk of fire or explosion. S 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.

ELECTROSURGICAL UNIT UES-30

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Important Information--Please Read Before Use

S During fiberscopic or videoscopic treatment, be sure that the Distal End of 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. S 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. S To ensure electrical safety, the UES-30 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. S The UES-30 should only be used in accordance with the conditions described in “Operating Environment” in the Appendix. Use under other conditions may impede normal performance, and/or result in equipment damage. S If the UES-30 is used in conjunction with a non-Olympus electrosurgical unit, keep the Electrosurgical Accessory away from the target area while the UES-30 is in operation. Do not activate output of both units simultaneously. Patient or operator injury may occur due to the concentration of electric current. S To prevent accidental output, the Hand Switch should be connected before turning ON the Power. S When using an electrocardiograph or other physiological monitoring equipment simultaneously with the UES-30 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-30. If placed too close, high frequency signals or spark discharge noise from the UES-30 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.

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ELECTROSURGICAL UNIT UES-30

Important Information--Please Read Before Use

OPEN-CIRCUIT OUTPUT VOLTAGE (V)

S The open-circuit voltage output characteristics of the UES-30 are shown below. When setting the output level, first set it to a low output level and increase it gradually. If the output is initially set to high level, insulation of the each electrode may be damaged and cause operator and/or patient burns. Furthermore, it is recommended that you conduct basic experiments before using the UES-30. 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. MONOPOLAR 6000 (4)

(2)

5000 4000

(5)

3000

(6) (7)

(1)

2000 (3)

1000 0

0

100

(1) NORMAL (2) SPRAY (3) SOFT (4) BLEND1 (5) BLEND2 (6) URO (7) PURE

300

200

OPEN-CIRCUIT OUTPUT VOLTAGE (V)

OUTPUT (W) BIPOLAR 3000 2500

(1) SOFT (2) PURE

(2)

2000 1500 1000

(1)

500 0

0

60 OUTPUT (W)

120

S Flammable agents used for cleaning and disinfection must be allowed to evaporate before the UES-30 is used. Also ensure that flammable solutions are neither on the patient’s skin nor in the patient’s body cavity when the UES-30 is used. S If the UES-30 is used in a laparoscopic procedure, direct access of insufflated CO2 gas to the vascular system (e.g. through an open vessel in the intra-abdominal cavity or an improperly inserted Veress needle) may result in gas embolism.

ELECTROSURGICAL UNIT UES-30

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Important Information--Please Read Before Use

S For surgical procedures where the high frequency current could flow through parts of the body having a relatively small cross-sectional area, the use of bipolar mode may be desirable to avoid accidental coagulation. S To prevent patient burns when the UES-30 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. S Temporarily unused electrodes should be stored in an electrically insulated container. Unused electrodes should never be placed on the patient. S The UES-30 should not be used for performing circumcisions. S 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 by the use of surgical smoke evacuators or other means. -- William S.Sawchuk, et al., “Infections Papilomavirus 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. S 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.

10

ELECTROSURGICAL UNIT UES-30

Important Information--Please Read Before Use

S If the UES-30 is used with a rigid endoscope and is providing monopolar output and in cause of treatment with rigid endoscope, activation of the UES-30 when not in contact with target tissue or in position to deliver energy to target tissue (fulguration) may cause capacitive coupling. S Do not use in a location exposed to strong electromagnetic radiation (microwave medical treatment equipment, short wave medical treatment equipment, MRI, radio or mobile phone). Wrong operation can occur. S Always confirm that the unit is safe to use in the overall system configuration that you are using. Mostly use the unit with other equipment referred to the “System Chart” in the Appendix. Use of the unit in a configuration that includes equipment NOT referred to the “System Chart” in the Appendix may not only prevent the unit from performing as intended, it can lead to injury of persons or damage to equipment. when you intend to use the unit in a configuration that includes equipment other than the type specified, check that the unit functions safely in that system configuration before proceeding. S Never approach the electrocautery tip to a metallic clip, electrosurgical accessory or retractor. Otherwise, the tissue in the vicinity may be burned. CAUTION

S To prevent instrument damage, never short-circuit electrodes (accessories, Hand Piece or Patient Plate). S Repairs should be performed only by Olympus.

ELECTROSURGICAL UNIT UES-30

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