EU M60 and EU M2000 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER Instructions April 2005

Contents

Contents Labels and Symbols...

1

Important Information - Please Read Before Use...

3

Intended use for EU--M60/EU--M2000...

3

Instruction manual for EU--M60/EU--M2000...

3

User qualifications...

5

Instrument compatibility...

5

Repair and modification...

5

Signal words...

6

Dangers, warnings and cautions...

7

Chapter 1

Checking the Package Contents...

10

1.1

Endoscopic ultrasound center (EU-M60/EU-M2000)...

11

1.2

Optional components...

13

Nomenclature and Functions...

14

2.1

Symbols and descriptions...

14

2.2

Front panel of the ultrasound center...

16

2.3

Rear panel of the ultrasound center...

17

2.4

Foot switch (MAJ-679)...

20

2.5

Keyboard (MAJ-930)...

21

2.6

Rear panel of the keyboard (MAJ-930)...

30

2.7

Side panel of the keyboard (MAJ-930)...

30

2.8

Cables...

31

2.9

Parts...

31

Installation...

32

3.1

Installation of the ultrasound center...

33

3.2

Installation of the ultrasound center with an EVIS system...

35

Connection...

40

4.1

Connection of the foot switch and keyboard...

41

4.2

Connection to a monitor...

42

4.3

Connection of the ultrasonic endoscope...

46

4.4

Connection of the probe driving unit...

49

4.5

Connection to a monochrome video printer...

52

4.6

Connection to a color video printer...

54

4.7

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

56

Chapter 2

Chapter 3

Chapter 4

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Contents

4.8

Connection to the video system center...

61

4.9

Connection to the digital filing equipment...

65

4.10 Connection to an external storage device...

67

4.11 Connection to an AC mains power supply...

69

Chapter 5

Preparation and Inspection...

71

5.1

Turning the ultrasound center ON and OFF...

71

5.2

Inspection if the power fails to come on...

73

5.3

Adjusting the monitor...

74

Chapter 6

Radial examination with an ultrasonic endoscope or ultrasonic probe...

75

6.1

Monitor display...

76

6.2

The on-screen menu...

78

How to operate the on-screen menu...

78

About the on-screen menu...

79

Setup...

83

Enter/modify the hospital name...

83

Enter/modify the date and time data...

84

Enter the patient data...

85

System setup -- Mode...

86

System setup -- Scope switch...

91

System setup -- Saved data format...

93

System setup -- # of cine review frames saved...

94

System setup -- Remote control...

95

System setup -- Frequency...

97

Selection of the socket...

98

6.3

Exchange of the ultrasonic endoscope, ultrasonic probe or probe driving unit

6.4

...

98

Reset...

99

Adjusting the ultrasonic image... 100 Gain... 100 Contrast... 100 Sensitivity time control (STC)... 101 Image... 102 Edge enhance... 102

6.5

Display functions... 103 Freeze... 103 Release... 103 Range selection... 104 Scanning display... 105 Image direction (R.DIR)... 106 Image rotation (I.R.)... 107

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Contents

Image scroll (SCRL)... 108 Selection of an image from memory (Radial plane)... 110 Selection of the frequency of the ultrasonic endoscope... 111 Enter comments on the ultrasonic image... 111 Delete stored annotations... 114 PinP (Sub Screen)... 116 Display (cursor) marks... 117

6.6

Cine Memory multi--screen display... 118

6.7

Measurement functions... 119 Distance measurement... 120 Area/circumference measurement by tracing... 124 Edit measurement(For 3D UPGRADE KIT)... 130

6.8

Trackball function direct access... 133

6.9

Preset... 134 Save preset data... 135 Open preset data... 135 Delete preset data... 136

6.10 Database... 137 Save data... 137 Open data... 141 Copy data... 143 Move data... 145 Delete data... 147 Free space... 149 Select copy destination... 150 Auto cine review... 151

6.11 Save and Release... 152 6.12 Backup... 153 Move data saved in current exam... 153 Move data saved today... 153 Move all saved data... 154

6.13 Operation of ancillary equipment (printer, VTR, etc.)... 155 Image recording using the monochrome video printer... 155 Image recording using the color video printer... 155 Image recording and playback using the VTR... 156 Control of the video system center... 157

6.14 Examination end... 158

Chapter 7

DPR examination with an ultrasonic probe and the probe driving unit (MAJ-935)... 159

7.1

Monitor display... 160

7.2

The on-screen menu... 161

7.3

Setup... 162

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Contents

7.4

Adjusting the ultrasonic image... 162

7.5

Display functions... 162 Freeze... 162 Release... 162 Range selection... 162 Scanning display... 162 Image direction (DIR)... 163 Image rotation (I.R.)... 166 Image scroll (SCRL)... 166 Selecting the Radial Plane (Radial Slicing)... 166 Selecting the Cutting Plane (Helical Slicing)... 168 Selection of the frequency of the ultrasonic endoscope... 168 Enter comments on the ultrasonic image... 168 Delete stored annotations... 168 PinP (Sub Screen)... 168 Display (cursor) marks... 169 Stroke... 169 Pitch... 169 Auto Stop... 170

7.6

Cine Memory multi--screen display... 171

7.7

Measurement functions... 171 Distance measurement... 171 Edit measurement (for 3D UPGRADE KIT)... 172 Area/circumference measurement by tracing... 172 Volume measurement... 173

7.8

Trackball function direct access... 175

7.9

Preset... 175

7.10 Database... 175 7.11 Backup... 175 7.12 Operation of ancillary equipment (printer, VTR, etc.)... 175 7.13 Examination end... 175

Chapter 8

3D examination with the ultrasonic probe and the prove driving unit (for 3D UPGRADE KIT)... 176

8.1

Monitor display... 177

8.2

The on-screen menu... 179

8.3

Setup... 184 Enter/modify the date and time data... 184 Enter the patient data... 184 System setup... 184 System setup -- Saved data format... 184 System setup -- Remote control... 184 System setup -- Frequency... 184

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3D setting... 184 3D image angle... 188 Variable plane angle... 190 Exchange of the ultrasonic endoscope, ultrasonic probe or probe driving unit ... 191 Reset... 191

8.4

Adjusting the ultrasonic image... 191

8.5

Display functions... 191 Freeze... 191 Release... 191 Range selection... 191 Scanning display... 192 Image direction (3D View)... 193 Image rotation (I.R.)... 194 3D rotation... 194 Variable plane... 196 Image scroll (SCRL)... 198 Selecting the Radial Plane (Radial Slicing)... 198 Selecting the Cutting Plane (Helical Slicing)... 198 Selection of the frequency of the ultrasonic endoscope... 198 Enter comments on the ultrasonic image... 198 Delete stored annotations... 198 PinP (Sub Screen)... 198 Display (cursor) marks... 199 Stroke... 199 Pitch... 199 Auto Stop... 199

8.6

Cine Memory multi--screen display... 199

8.7

Measurement functions... 199 Distance measurement... 199 Area/circumference measurement by tracing... 199 Edit measurement... 200 Volume measurement... 200 Interpolation for trace measurement... 200 Volume display... 201 Multi--echo boundaries... 202

8.8

Trackball function direct access... 204

8.9

Preset... 204

8.10 Database... 204 8.11 Backup... 204 8.12 Operation of ancillary equipment (printer, VTR, etc.)... 204 8.13 Examination end... 204

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Contents

Chapter 9

Manual scanning DPR examination with an ultrasonic endoscope (for 3D UPGRADE KIT)... 205

9.1

Monitor display... 206

9.2

The on-screen menu... 206

9.3

Setup... 206

9.4

Adjusting the ultrasonic image... 206

9.5

Display functions... 207 Freeze... 207 Release... 207 Range selection... 207 Scanning display... 207 Image direction (DIR)... 207 Image rotation (I.R.)... 207 Image scroll (SCRL)... 207 Selecting the Radial Plane (Radial Slicing)... 208 Selecting the Cutting Plane (Helical Slicing)... 208 Selection of the frequency of the ultrasonic endoscope... 208 Enter comments on the ultrasonic image... 208 Delete stored annotations... 208 PinP (Sub Screen)... 208 Display (cursor) marks... 208 Stroke... 209 Pitch... 209 Auto Stop... 209

9.6

Cine Memory multi--screen display... 210

9.7

Measurement functions... 210

9.8

Trackball function direct access... 210

9.9

Preset... 210

9.10 Database... 210 9.11 Backup... 210 9.12 Operation of ancillary equipment (printer, VTR, etc.)... 211 9.13 Examination end... 211

Chapter 10 Manual scanning 3D examination with an ultrasonic endoscope (for 3D UPGRADE KIT)... 212 10.1 Monitor display... 213 10.2 The on-screen menu... 213 10.3 Setup... 213 10.4 Adjusting the ultrasonic image... 213 10.5 Display functions... 214 Freeze... 214 Release... 214

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Range selection... 214 Scanning display... 214 Image direction (3D View)... 214 Image rotation (I.R.)... 214 3D rotation... 214 Variable plane... 214 Image scroll (SCRL)... 214 Selecting the Radial Plane (Radial Slicing)... 215 Selecting the Cutting Plane (Helical Slicing)... 215 Selection of the frequency of the ultrasonic endoscope... 215 Enter comments on the ultrasonic image... 215 Delete stored annotations... 215 PinP (Sub Screen)... 215 Display (cursor) marks... 215 Stroke... 216 Pitch... 216 Auto Stop... 216

10.6 Cine Memory multi--screen display... 217 10.7 Measurement functions... 217 10.8 Trackball function direct access... 217 10.9 Preset... 217 10.10 Database... 217 10.11 Backup... 217 10.12 Operation of ancillary equipment (printer, VTR, etc.)... 218 10.13 Examination end... 218

Chapter 11 Care, Storage and Disposal... 219 11.1 Care... 219 11.2 Storage... 220 11.3 Disposal... 220

Chapter 12 Troubleshooting... 221 12.1 Troubleshooting guide... 221 12.2 Warning messages... 223 12.3 Error messages... 226 12.4 Returning the ultrasound center for repair... 227

Appendix... 229 About DPR (Dual Plane Reconstruction) Examination... 229 About 3D Examination... 230 System chart... 231 Operating and storage environments... 234 Specifications... 234 ENDOSCOPIC ULTRASOUND CENTER EU-M60/EU-M2000

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Contents

Acoustic output tables... 238 EMC information... 247

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ENDOSCOPIC ULTRASOUND CENTER EU-M60/EU-M2000

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.

Refer to instructions.

Crossed-out wheeled bin’ symbol

0197

CE marking

Circuit breakers

Electrical rating plate The product name, rated voltage, frequency and serial number are shown.

Potential equalization terminal

ENDOSCOPIC ULTRASOUND CENTER EU-M60/EU-M2000

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Labels and Symbols

Electrical rating plate EU-M60

EUS EXERA ENDOSCOPIC ULTRASOUND CENTER MODEL EU-M60 INPUT 220--240V 50/60Hz 1.5A SN EU-M2000

EndoEcho ENDOSCOPIC ULTRASOUND CENTER MODEL EU-M2000 INPUT 220--240V 50/60Hz 1.5A SN

CE marking IPX1 Indicates that the foot switch is protected from dripping liquid.

Foot switch (MAJ-679)

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ENDOSCOPIC ULTRASOUND CENTER EU-M60/EU-M2000

Important Information -- Please Read Before Use

Important Information - Please Read Before Use Intended use for EU- M60/EU- M2000 This ultrasound center has been designed to be used with Olympus ultrasonic endoscopes, Olympus ultrasonic probes or Olympus esophageal ultrasonic probe to observe and to store real-time, ultrasonic images within the gastrointestinal (GI) tract, biliary and pancreatic ducts and surrounding organs, upper airways and tracheobronchial tree, urinary tract and female reproductive organs. Do not use this device for any purpose other than its intended use.

Instruction manual for EU- M60/EU- M2000 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. This instruction manual describes functionality of the EU--M60/EU--M2000 that is available only after the 3D UPGRADE KIT (MAJ--1330) has been installed. 3D functions are not available on the EU--M60/EU--M2000 without the 3D UPGRADE KIT (MAJ--1330) installed. For installation instructions, refer to the manual that accompanied the MAJ--1330 at shipment. 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 an electric shock. Wall mains outlet: The wall mains outlet is a wall AC mains outlet socket having a terminal used exclusively for grounding.

ENDOSCOPIC ULTRASOUND CENTER EU-M60/EU-M2000

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Important Information -- Please Read Before Use

Video system center: The video system center is a device that converts electronic signals from a videoscope into images that can be displayed on a monitor. Video printer: The video printer is a device that prints the frozen video image. Freeze mode: In the FREEZE mode, the ultrasound center displays a stationary ultrasound image. REAL-TIME mode: In the REAL-TIME mode, the ultrasound center creates the real-time ultrasound image. DPR (Dual Plane Reconstruction) examination: DPR (Dual Plane Reconstruction) examination is based on linear and radial scanning with the probe driving unit (MAJ-935) and the DPR ultrasonic probe. 3D examination: DPR examination with 3D display. Dual display: The dual display shows both the radial and linear images at equal sizes during a DPR examination. Radial-priority display: The radial-priority display shows a magnified radial image together with a subscreen showing the linear image during a DPR examination. Linear-priority display: The linear-priority display shows a magnified linear image together with a subscreen showing the radial image during a DPR examination. Stroke: The stroke is the movement range of linear scanning in the direction of the insertion axis. Pitch: The pitch is the interval of movement in linear scanning. External storage device: This is an external SCSI device with a SCSI connection. Model with 3D UPGRADE KIT preinstalled: This is the EU--M60/EU--M2000 with the factory--installed 3D UPGRADE KIT.

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ENDOSCOPIC ULTRASOUND CENTER EU-M60/EU-M2000

Important Information -- Please Read Before Use

3D UPGRADE KIT: Installation adds features such as 3D display of ultrasonic images. 3D display: In 3D examination, 3D display is performed by re--building multiple, consecutive 2D images acquired by 3D scanning. MPR display: Displays radial images, vertical linear images horizontal images and 3D images on a screen divided into four parts during 3D examination. Multi--screen display: Displays multiple radial examination images simultaneously on a split screen.

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.

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 and/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 12, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 12, contact Olympus.

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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.

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ENDOSCOPIC ULTRASOUND CENTER EU-M60/EU-M2000

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 a TYPE BF applied part. S Because the ultrasound center is a TYPE BF applied part, the ultrasonic endoscope connected to it must never be applied directly to the heart. Leakage current from a TYPE BF applied part may be dangerous and could cause ventricular fibrillation or otherwise seriously affect the cardiac function of the patient. Accordingly, always adhere to the following points: -- Never apply the ultrasonic endoscope connected to this ultrasound center to the heart or any area near the heart. -- Never allow an endo-therapy accessory or another ultrasonic endoscope applied to or near the heart to come in contact with the ultrasonic endoscope connected to this ultrasound center. S Strictly observe the following precautions. Failure to do so may place the patient and medical personnel in danger of an electric shock: -- When this ultrasound center is used to examine a patient, do not allow metal parts of the ultrasonic endoscope or its accessories to touch metal parts of other system components. Such contact may cause unintended current flow to the patient. -- Keep fluids away from all electrical equipment. If fluids are spilled on or into the unit, stop operation of the ultrasound center immediately and contact Olympus. -- Do not prepare, inspect or use this ultrasound center with wet hands.

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Important Information -- Please Read Before Use

S Never install or operate the ultrasound center in locations 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. Otherwise, explosion or fire may result because this ultrasound center is not explosion-proof. S To prevent electric shock hazards, the frame of the ultrasound center must be grounded securely and effectively. 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 an environment where electrical noise is generated by electrosurgical 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 damage to the ultrasound center, never touch the electrical contacts in the sockets. S Do not place objects on or near the ventilation grills on the rear panel 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 that device has undergone a full safety check.

S Do not place the product on it side. Otherwise, the ultrasound center may fall and become damaged and/or cause injury. S Do not use the ultrasound center under conditions other than those specified in “Operating and storage environments” in the Appendix. S Do not use a pointed or hard object to press the keys or switches on the keyboard. This could damage the keyboard.

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ENDOSCOPIC ULTRASOUND CENTER EU-M60/EU-M2000

Important Information -- Please Read Before Use

S Do not connect the “100 BASE-TX” terminal to an ISDN circuit. Otherwise, the ultrasound center and the equipment connected to the ISDN circuit may be damaged. S To prevent unnecessary patient exposure to ultrasonic radiation, follow the ‘as--low--as--reasonably achievable’ (ALARA) principle when using Olympus ultrasonic equipment. Freeze the image whenever you are not actively viewing the “live” ultrasonic image. When the equipment is in the FREEZE mode, no ultrasonic energy is emitted. 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.

S As defined by the international safety standard (IEC 60601-1), medical electrical equipment is classified into the following types: TYPE CF applied parts (the instrument can safely be applied to any part of the body, including the heart), and TYPE BF applied parts (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-M60/EU-M2000

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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.

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ENDOSCOPIC ULTRASOUND CENTER EU-M60/EU-M2000

Chapter 1 Checking the Package Contents

1.1

Endoscopic ultrasound center (EU-M60/EU-M2000)

Keyboard (MAJ-930) Endoscopic ultrasound center (EU-M60/EU-M2000)

Microdriver

A B C D E

Foot switch (MAJ-679)

Foot holders

Function templates On the EU-M2000, template A is not used.

Pattern sheet

Power cord

BNC cable (MB-672) Round socket cap

Square socket cap Remote cable (MH-907)

Instruction manual (EU--M60/EU--M2000)

MicrosoftR End User License Agreement

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