EU-M30S ENDOSCOPIC ULTRASOUND CENTER Instructions April 2005

HHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHH ©2000 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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Contents

Contents 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...

8

1.1

Endoscopic ultrasound center (EU-M30S)...

9

1.2

Probe driving unit (MAJ-682)...

10

1.3

Optional components...

10

Nomenclature and Functions...

12

2.1

Symbols and descriptions...

12

2.2

Front panel of the EU-M30S...

13

2.3

Rear panel of the EU-M30S...

14

2.4

Foot switch (MAJ-679)...

16

2.5

Keyboard (MAJ-680)...

17

2.6

Cables...

20

Installation...

21

Chapter 2

Chapter 3 3.1

Installation of the ultrasound center in a stand alone ultrasonic system ...

22

Installation of the ultrasound center with the EVIS or OES system

24

Connection...

27

4.1

Connection of the foot switch...

28

4.2

Connection of the keyboard...

29

4.3

Connection to a monitor...

30

4.4

Connection to a monochrome video printer...

32

4.5

Connection to a color video printer...

33

4.6

Connection to a video tape recorder (VTR)...

36

4.7

Connection of the probe driving unit (MAJ-682)...

38

4.8

Connection to the EVIS or OES TV system...

40

3.2

Chapter 4

ENDOSCOPIC ULTRASOUND CENTER EU-M30S

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Contents

4.9

Connection when the video system center (CV-260) is in the HDTV mode ... 45

4.10 Connection to an AC mains power supply...

Chapter 5

Preparation and Inspection...

49

5.1

Turning the ultrasound center ON...

49

5.2

Inspection if the power fails to come on...

50

5.3

Inspection of the ultrasonic image...

51

5.4

Adjusting the monitor...

52

5.5

Inspection of the EVIS or the OES TV system...

53

Operation...

54

6.1

Monitor display...

54

6.2

The on-screen menu...

56

Chapter 6

6.3

6.4

6.5

6.6

6.7

ii

47

About the on-screen menu...

56

How to operate the on-screen menu...

60

Setup...

62

Enter/modify the hospital name...

62

Enter/modify the date and time data...

63

Enter the patient ID data...

65

Adjusting the ultrasonic image...

66

Gain...

66

Contrast...

66

Sensitivity time control (STC)...

67

Image...

68

Display functions...

68

Freeze...

68

Release...

69

Scanning display...

69

Range selection...

70

Image direction (DIR)...

71

Image rotation (I.R.)...

71

Image scroll (SCRL)...

72

Current image selection...

74

Enter comments on the ultrasonic image...

75

Examination end...

75

Measurement functions...

76

Distance measurement...

77

Area/circumference measurement by tracing...

81

Area/circumference measurement by approximating an ellipse...

86

Preset functions...

91

Preset save...

91

Preset load...

94

ENDOSCOPIC ULTRASOUND CENTER EU-M30S

Contents

6.8

Preset delete...

96

Option...

99

Display marks...

99

Clear mode... 101 Freeze mode... 104 Reset... 105

6.9

Chapter 7

Recording... 107

Care, Storage and Disposal... 108

7.1

Care... 108

7.2

Storage... 109

7.3

Disposal... 109

Chapter 8

Troubleshooting... 110

8.1

Troubleshooting guide... 110

8.2

Returning the ultrasound center for repair... 112

Appendix... 114 Surface area and circumference measurements by ellipse approximation

114

System chart... 115 Operating and storage environments... 118 Specifications... 118 Acoustic output tables... 121 EMC information... 140

ENDOSCOPIC ULTRASOUND CENTER EU-M30S

iii

Contents

iv

ENDOSCOPIC ULTRASOUND CENTER EU-M30S

Labels and Symbols

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

Crossed-out wheeled bin’ symbol

CE marking Refer to instructions.

Circuit breakers

Electrical rating The product name, rated voltage, frequency and serial number are shown. ENDOSCOPIC ULTRASOUND CENTER MODEL EU-M30S

INPUT 220--240V

Potential equalization terminal

50/60Hz 0.6A

SN

ENDOSCOPIC ULTRASOUND CENTER EU-M30S

1

Labels and Symbols

CE marking IPX1 Drip proof (the foot switch is protected from dripped water)

Foot switch (MAJ-679)

CE marking Keyboard (MAJ-680)

2

ENDOSCOPIC ULTRASOUND CENTER EU-M30S

Important Information -- Please Read Before Use

Important Information - Please Read Before Use Intended use This ultrasound center has been designed to be used with Olympus ultrasonic probes to observe real-time, ultrasonic images. Do not use for any purpose other than its intended use.

Instruction manual This instruction manual contains essential information on using this ultrasound center 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 Isolation transformer: The isolation transformer is a safety device that is used to isolate non-insulated, equipment with potentially high leakage currents to decrease the possibility of electric shock.

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

ENDOSCOPIC ULTRASOUND CENTER EU-M30S

3

Important Information -- Please Read Before Use

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

Repair and modification This ultrasound center 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 8, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 8, 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

ENDOSCOPIC ULTRASOUND CENTER EU-M30S

Important Information -- Please Read Before Use

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

S The ultrasound center is not explosion-proof. Do not use the ultrasound center where flammable anesthetics are used, in an area when there is a high oxygen concentrations or in a room recently washed with flammable cleaning or disinfecting agents. Some cleaners/disinfectants can produce explosive vapors. S The ultrasound center is a TYPE BF applied part. S Leakage current from TYPE BF applied part may be dangerous and cause ventricular fibrillation or otherwise seriously affect the cardiac function of the patient. Accordingly, always adhere to the following points. -- Never apply a connected ultrasonic endoscope or probe to the heart. -- Never allow an accessory, another endoscope, etc. which is in contact with the heart (or an area around heart) to come into contact with the ultrasonic endoscope or probe, when connected to the ultrasound center. S Observe the following precautions carefully. Failure to do so may place the patient and/or medical personnel at risk of electrical shock. -- Never use the ultrasound center in conjunction with electro-surgical equipment. -- Keep liquids away from the ultrasound center. If spilled liquid has entered the ultrasound center, stop the operation immediately and contact Olympus. -- Do not prepare, inspect or use the ultrasound center with wet hands. -- Always connect all ancillary equipment to an AC mains outlet via an isolation transformer. S To prevent electrical shock hazards, the main frame of the ultrasound center must be grounded securely and effectively.

ENDOSCOPIC ULTRASOUND CENTER EU-M30S

5

Important Information -- Please Read Before Use

S Use only a grounded wall mains outlet when connecting the ultrasound center. Failure to do so may cause electric shock or fire.

S Do not use the ultrasound center in environment where electrical noise is generated by electro-surgical equipment, etc. S When using the ultrasonic endoscope or probe in conjunction with an X-ray device, electrical noise may appear in the ultrasonic image. S To prevent the ultrasound center damage, never touch the electrical contacts of the socket. S Do not place objects on or near the ventilation grills of the ultrasound center while it is in use. S When the ultrasound center is used in conjunction with any other electrical device, always ensure that the device has undergone a full safety check.

S Do not install this ultrasound center on one of its sides. Otherwise, the ultrasound center may fall and cause damage or injury. S Do not use the ultrasound center under other conditions than those specified in “Operating environment” in the Appendix. S Do not use a pointed or hard object to press the switches on the keyboard. This may break the switches. S Electromagnetic interference may occur on this instrument near equipment marked with the following symbol or other portable and mobile RF (Radio Frequency) communications equipment such as cellular phones. If electromagnetic interference occurs, mitigation measures may be necessary, such as reorienting or relocating this instrument, or shielding the location.

6

ENDOSCOPIC ULTRASOUND CENTER EU-M30S

Important Information -- Please Read Before Use

As defined by the international safety standard (IEC60601-1), medical electrical equipment is classified into the following types: TYPE CF applied part (the instrument can safely be applied to any part of the body, including the heart), and TYPE BF applied part (the instrument can safely be applied to any organ except the heart). The part of the body an endoscope or electrosurgical accessory can safely be applied to depends on the classification of the equipment to which the instruments are connected. Before beginning the procedure, check the current leakage classification type of each instrument to be used for the procedure. Classification types are clearly specified in the instruments’ instruction manuals. Symbol

Classification TYPE CF applied part

TYPE BF applied part

ENDOSCOPIC ULTRASOUND CENTER EU-M30S

7

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 ultrasound center is damaged, a component is missing or you have any questions, do not use the ultrasound center; immediately contact Olympus.

8

ENDOSCOPIC ULTRASOUND CENTER EU-M30S

Chapter 1 Checking the Package Contents

1.1

Endoscopic ultrasound center (EU-M30S)

Keyboard (MAJ-680)

Endoscopic ultrasound center (EU-M30S)

Socket cap

Remote cable (MH-907) Foot switch (MAJ-679)

BNC cable (MB-672)

RGB cable (MAJ-686)

Power cord

Instruction manual

ENDOSCOPIC ULTRASOUND CENTER EU-M30S

9

Chapter 1 Checking the Package Contents

1.2

Probe driving unit (MAJ-682) The probe driving unit (MAJ-682) is attached to the ultrasound center to run an ultrasonic probe.

Probe driving unit (MAJ-682)

1.3

Optional components The items listed below are optional, and may be purchased from Olympus.

` S cable (MH-985) The S cable is used for connecting the ultrasound center to a video tape recorder.

10

ENDOSCOPIC ULTRASOUND CENTER EU-M30S

Chapter 1 Checking the Package Contents

` RGB input cable (MAJ-685) The RGB input cable is used for connecting the ultrasound center to the OES TV system.

` RGB input cable (MAJ-697) The RGB input cable is used for connecting the ultrasound center to an EVIS video system center.

` RGB input cable (MAJ-883) The RGB input cable is used for connecting the ultrasound center to an EVIS video system center.

ENDOSCOPIC ULTRASOUND CENTER EU-M30S

11

Chapter 2 Nomenclature and Functions

Chapter 2 Nomenclature and Functions 2.1

Symbols and descriptions ` Front panel Power ON

Power OFF

` Foot switch Freeze

Release

` Keyboard

12

Freeze

Release

Image direction

Full circle

Top sector

Bottom sector

Image rotation

Image scroll

Range

Contrast

Gain

Sensitivity time control (STC)

Ultrasound

Scope

Monitor

Image

Clear

Menu

ENDOSCOPIC ULTRASOUND CENTER EU-M30S

Chapter 2 Nomenclature and Functions

Preset

Set

Caliper

Caliper

Return

2.2

Front panel of the EU-M30S Handle

EU-M30S

Endoscopic Ultrasound Center

ON

OFF

1. Power switch

2. Socket

1. Power switch The power switch is lit in green while the ultrasound center is ON. 2. Socket The probe driving unit (MAJ-682) is connected to this socket.

ENDOSCOPIC ULTRASOUND CENTER EU-M30S

13