SonoSurg-T2L-GE Ultrasonic Surgical System and SonoSurg-IU Irrigation Unit Instructions

HHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHH ©2004 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.

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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

GE2557 03

Printed in Japan 20050531 :0000

Contents

Contents Labels and Symbols...

1

Important Information – Please Read Before Use...

2

Intended use...

2

Instruction manual...

2

User qualifications...

2

Instrument compatibility...

3

Reprocessing and storage...

3

Repair and modification...

3

Signal words...

4

Dangers and warnings...

4

Chapter 1

Checking the Package Contents...

7

Chapter 2

Instrument Nomenclature...

15

Chapter 3

Preparation and Inspection of the SonoSurg Irrigation Unit...

33

3.1

Preparation of equipment...

33

3.2

Installation of the SonoSurg irrigation unit...

34

3.3

Power connection for the SonoSurg irrigation unit...

35

3.4

Connection of the foot switch...

36

3.5

Connection to the SonoSurg generator (SonoSurg-G2)...

38

3.6

Inspection of the power supply...

39

3.7

Inspection of the suction mode...

43

Chapter 4

Preparation, Inspection and Connection of the Hand Piece...

44

4.1

Preparation of the equipment...

45

4.2

Inspection and connection of the transducer, probe and sheath . . .

47

4.3

Inspection and connection of the irrigation/suction tube for SonoSurg (MAJ-1099)...

55

4.4

Connection of the hand piece plug...

66

4.5

Preparation and inspection of the electrosurgical unit...

67

4.6

Inspection of compatibility with the trocar tube...

72

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Contents

Chapter 5

Inspection of the System...

73

5.1

Inspection of the generator and the irrigation unit...

73

5.2

Inspection of the suction...

75

5.3

Inspection of cooling water...

76

5.4

Inspection of ultrasonic output...

78

Operation...

81

6.1

Turning the power ON...

86

6.2

Setting the suction pressure...

86

6.3

Setting the output level...

88

6.4

Setting the irrigation level...

89

6.5

Procedure...

90

6.6

Electrosurgical treatment...

93

6.7

After use...

95

6.8

Warning indications...

96

Reprocessing and Storage...

98

7.1

Reprocessing: General policy...

98

7.2

Precautions...

99

7.3

Compatible reprocessing methods and chemical agents... 101

7.4

Cleaning and sterilization procedures... 110

7.5

Care... 116

7.6

Storage... 117

7.7

Disposal... 117

Chapter 6

Chapter 7

Chapter 8

Troubleshooting... 118

8.1

Troubleshooting guide... 119

8.2

When the ultrasonic output warning lamp is lit... 125

8.3

Returning the equipment for repair... 126

Appendix... 128 System chart... 128 Operating environment... 130 Specifications... 130 EMC compliance information... 136

Maintenance... 140

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SonoSurg Transducer SonoSurg-T2L-GE/SonoSurg-T2L-GE-C SonoSurg Irrigation Unit SonoSurg-IU

Labels and Symbols

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

Electrical rating plate The product name and rated voltage are displayed.

Caution Plate Shows the proper tubing connection.

Serial number plate Electrical rating plate SonoSurg Irrigation Unit MODEL: SonoSurg-IU

SonoSurg Irrigation Unit MODEL: SonoSurg-IU

INPUT

INPUT

120V 1A 50/60Hz

(120 V)

Caution Plate

220--240V 0.5A 50/60Hz

(220 -- 240 V)

SonoSurg Transducer SonoSurg-T2L-GE/SonoSurg-T2L-GE-C SonoSurg Irrigation Unit SonoSurg-IU

1

Important Information -- Please Read Before Use

Important Information – Please Read Before Use Intended use These devices have been designed to be used with the SonoSurg generator (SonoSurg-G2) and a separate surgical suction device to dissect, fragment, emulsify and aspirate tissue for general surgery, laparoscopic surgery, plastic and reconstructive surgery and urologic surgery. These devices may also be combined with electrosurgery using Olympus electrosurgical Units. Do not use these 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.

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 clinical techniques. This manual, therefore, does not explain or discuss these techniques.

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SonoSurg Transducer SonoSurg-T2L-GE/SonoSurg-T2L-GE-C SonoSurg Irrigation Unit SonoSurg-IU

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. If this instrument is used in combination with equipment manufactured by other companies, confirm their compatibility before use. 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 medical electrical equipment edition 1 (IEC 60601-1-2:1993), the whole system complies with edition 1. (See “EMC compliance information” on page 136 for EMC compliance level.)

Reprocessing and storage The transducer and ancillary components (e.g. probes and sheaths, which are sold separately) were not sterilized before shipment. Before using them for the first time, reprocess them according to the instructions given in Chapter 7, “Reprocessing and Storage”. After using the instruments, reprocess and store them according to the instructions given in Chapter 7, “Reprocessing and Storage”. Improper and/or incomplete reprocessing or storage can present an infection control risk, cause equipment damage or reduce performance.

Repair and modification This instrument does not contain any user-serviceable parts. Do not disassemble, modify or attempt to repair it. Otherwise, patient or user injury and/or equipment damage can result. Problems that appear to be malfunctions may be correctable by referring to Chapter 8, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 8, contact Olympus.

SonoSurg Transducer SonoSurg-T2L-GE/SonoSurg-T2L-GE-C SonoSurg Irrigation Unit SonoSurg-IU

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Important Information -- Please Read Before Use

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.

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

S These devices are not explosion-proof. Do not use them where flammable gases or liquids or high concentrations of oxygen may be present. Otherwise, an explosion or fire may occur. S These devices are not intended to be used for dissection, fragmentation, emulsification, or aspiration of fatty cells for liposuction.

4

SonoSurg Transducer SonoSurg-T2L-GE/SonoSurg-T2L-GE-C SonoSurg Irrigation Unit SonoSurg-IU

Important Information -- Please Read Before Use

S Do not prepare or operate this instrument with wet hands. Otherwise, the user may receive an electric shock. S Always have a defibrillator ready in case of a cardiac emergency. Before operating the defibrillator, remove the instrument and endoscope from the patient. Also make preparations for an abdominal operation if necessary. S Use this instrument in an environment equipped to accommodate open surgery and have the hospitalization plan prepared in case any problem occurs that may not be resolved by form of endoscopic surgery. S To ensure electrical safety, this instrument should not be used in conjunction with: -- Electromedical equipment whose safety in combined use is not guaranteed. -- Electromedical equipment whose safety against leakage current is not guaranteed. When performing electrosurgery, special attention should be paid to the following:

S Never apply this instrument directly to the heart in combination with a TYPE B/BF electrosurgical unit. Doing so may cause ventricular fibrillation, which could be fatal to the patient. S The HF-equipment, when applied to a patient with a pacemaker implanted, may cause malfunctioning or failure of the pacemaker and may seriously affect the patient. Before proceeding, confirm with a cardiologist or the manufacturer of the pacemaker that it is safe to do so.

S Be sure not to bring and/or pile up this instrument too close to other instruments to avoid an electromagnetic interference from them. S Electromagnetic interference may occur on this instrument near a portable device and a mobile RF communications equipment such as a cellphone marked with the following symbol:

SonoSurg Transducer SonoSurg-T2L-GE/SonoSurg-T2L-GE-C SonoSurg Irrigation Unit SonoSurg-IU

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Important Information -- Please Read Before Use

S Never loop the A-cord or bundle it together with the cords belonging to other medical equipment (e.g. electrocardiograph, video camera for endoscopes, etc.). Otherwise, the high-frequency signals or spark discharge noise generated may interfere with the operation of the medical equipment during electrosurgery. S If the intestines contain a flammable gas, replace this gas with a nonflammable gas such as CO2 before the procedure to minimize the risk of fire or explosion.

S The safety standard for electromedical equipment (IEC 60601-1) classifies equipment into TYPE CF (applicable to the whole human body including the heart) and TYPE B/BF (applicable to organs other than the heart). As the applicable region of the instruments varies depending on the classification of connected equipment, it is necessary that this classification first be checked by referring to the instruction manual of the electromedical equipment in use. Symbol

Classification TYPE CF applied part

TYPE BF applied part

TYPE B applied part

S Exercise special care when electrosurgical output is applied in the vicinity of the heart. Current flowing through the heart or the low-frequency current generated by rectification during spark discharge may cause ventricular fibrillation, even when this instrument is used in combination with a TYPE CF electrosurgical unit.

6

SonoSurg Transducer SonoSurg-T2L-GE/SonoSurg-T2L-GE-C SonoSurg Irrigation Unit SonoSurg-IU

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 these instruments are damaged, a component is missing or you have any questions, do not use these instruments; immediately contact Olympus. The transducer and ancillary components (e.g. probes and sheaths) were not sterilized before shipment. Before using them for the first time, reprocess them according to the instructions given in Chapter 7, “Reprocessing and Storage”. This instruction manual is shipped with the SonoSurg Transducer (SonoSurg-T2L-GE/SonoSurg-T2L-GE-C) and the SonoSurg Irrigation Unit (SonoSurg-IU).

SonoSurg Transducer (SonoSurg-T2L-GE)

Instruction manual SonoSurg Transducer (SonoSurg-T2L-GE)

SonoSurg Transducer (SonoSurg-T2L-GE-C)

Instruction manual SonoSurg Transducer (SonoSurg-T2L-GE-C)

SonoSurg Transducer SonoSurg-T2L-GE/SonoSurg-T2L-GE-C SonoSurg Irrigation Unit SonoSurg-IU

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Chapter 1 Checking the Package Contents

SonoSurg Irrigation Unit (SonoSurg-IU)

SonoSurg Communication Cable (MAJ-1103) SonoSurg Irrigation Unit (SonoSurg-IU)

Instruction manual Power cord

8

SonoSurg Transducer SonoSurg-T2L-GE/SonoSurg-T2L-GE-C SonoSurg Irrigation Unit SonoSurg-IU

Chapter 1 Checking the Package Contents

The following Olympus items are optional and may be purchased separately:

Foot Switch for SonoSurg Irrigation Unit (MAJ-1102)

Foot Switch for SonoSurg Irrigation Unit (MAJ-1102)

SonoSurg Connection Cable (MAJ-1121)

SonoSurg Connection Cable (MAJ-1121)

Probe (Straight) (MH-112)

Probe (Straight) (MH-112)

SonoSurg Transducer SonoSurg-T2L-GE/SonoSurg-T2L-GE-C SonoSurg Irrigation Unit SonoSurg-IU

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Chapter 1 Checking the Package Contents

The following Olympus items are optional and may be purchased separately:

Probe (15° Angled) (MH-113)

Probe (15° Angled) (MH-113)

Probe (Tapered, Long) (MH-125)

Probe (Tapered, Long) (MH-125)

SonoSurg GE Straight Sheath (T3310)

SonoSurg GE Sheath Attachment (T3300), × 3 SonoSurg GE Straight Sheath (T3310)

10

SonoSurg Transducer SonoSurg-T2L-GE/SonoSurg-T2L-GE-C SonoSurg Irrigation Unit SonoSurg-IU

Chapter 1 Checking the Package Contents

The following Olympus items are optional and may be purchased separately:

SonoSurg GE Sheath (15° Angled) (T3320)

SonoSurg GE Sheath Attachment (T3300), × 3

SonoSurg GE Sheath (15° Angled) (T3320)

SonoSurg GE Tapered Sheath (T3330)

SonoSurg GE Tapered Sheath (T3330)

SonoSurg GE Sheath Attachment (T3300), × 3

SonoSurg GE Sheath Attachment (T3300)

SonoSurg GE Sheath Attachment (T3300), × 3

SonoSurg Transducer SonoSurg-T2L-GE/SonoSurg-T2L-GE-C SonoSurg Irrigation Unit SonoSurg-IU

11

Chapter 1 Checking the Package Contents

The following Olympus items are optional and may be purchased separately:

Irrigation/Suction Tube for SonoSurg (MAJ-1099) (disposable, sterile)

SonoSurg Irrigation/Suction Tube for SonoSurg (MAJ-1099), × 6

SonoSurg GE Hand Switch (MAJ-1100)

SonoSurg GE hand switch (MAJ-1100)

Cleaning Rod (MAJ-1178)

Cleaning Rod (MAJ-1178)

12

SonoSurg Transducer SonoSurg-T2L-GE/SonoSurg-T2L-GE-C SonoSurg Irrigation Unit SonoSurg-IU

Chapter 1 Checking the Package Contents

The following Olympus items are optional and may be purchased separately:

Cleaning Brush (MH-140)

Cleaning Brush (MH-140)

Cleaning Brush (NSG-BW)

Cleaning Brush (NSG-BW)

Brush (MH-507)

Brush (MH-507)

SonoSurg Transducer SonoSurg-T2L-GE/SonoSurg-T2L-GE-C SonoSurg Irrigation Unit SonoSurg-IU

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Chapter 1 Checking the Package Contents

The following Olympus items are optional and may be purchased separately:

6mm Torque Wrench (MAJ-1117)

6mm Torque Wrench (MAJ-1117)

14

SonoSurg Transducer SonoSurg-T2L-GE/SonoSurg-T2L-GE-C SonoSurg Irrigation Unit SonoSurg-IU

Chapter 2 Instrument Nomenclature

Chapter 2 Instrument Nomenclature Symbols and Descriptions ` Warning section COMM.

Communication error

` Power switch

Power OFF

Power ON

` Front panel

Flush

Irrigation

Suction mode select

Normal suction

Laparoscopic suction

SonoSurg Transducer SonoSurg-T2L-GE/SonoSurg-T2L-GE-C SonoSurg Irrigation Unit SonoSurg-IU

15