EU-ME3 ENDOSCOPIC CENTER Instructions

Contents

Contents Labels and Symbols ... 1 Important Information - Please Read Before Use ... 4 Intended use/Intended purpose ... 4 Contraindications ... 4 Clinical benefit ... 4 Instruction manual ... 4 User qualifications ... 10 Instrument compatibility ... 10 Repair and modification ... 10 Signal words ... 11 Precautions ... 11 About Security ... 15 ALARA principle ... 15 Reference materials ... 16

Summary of Equipment Functions ... 17 Standard functions and functions that can be activated by software options ... 17 Types of ultrasound probes and ultrasound endoscopes and their available functions ... 18

Chapter 1 Checking the Package Contents ... 19 1.1

Checking the package contents ... 19

Chapter 2 Nomenclature and Functions ... 21 2.1

Front panel ... 21

2.2

Rear panel ... 24

2.3

Sides of the Ultrasound Center ... 26

2.4

Keyboard (MAJ-2380) ... 27

2.5

Rear panel of the keyboard (MAJ-2380) ... 30

2.6

Keyboard AC adapter (MPU16A-102) ... 30

2.7

Monitor display ... 31

Chapter 3 Installation and Connection ... 33 3.1

Precautions for installation and connection ... 33

3.2

Installation workflow ... 35

3.3

Installation of the equipment ... 36 Installation of the equipment ... 37

3.4

Installation of the accessories ... 38 Installation of keyboard and keyboard AC adapter ... 38

3.5

Connection of the power supply ... 39

3.6

Connect with the monitor ... 43 Compatible monitor ... 43 EU-ME3 INSTRUCTION MANUAL

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Connection with OEV321UH ... 44 Connection with OEV262H ... 46

3.7

Connect with the keyboard ... 48 Compatible keyboard ... 48 Connection with the keyboard (MAJ-2380) ... 48

3.8

Connection with the digital video recorder ... 50 Compatible digital video recorder ... 50 Connection with IMH-200 ... 50

3.9

Connection with the video system center ... 52 Compatible video system center ... 52 Connection with CV-1500 and ultrasound endoscopes of 190/290 series or later ... 53 Connection with CV-1500 and ultrasound endoscopes of 160/180/260 series ... 55 Connection with CV-290, CV-190, or CV-190PLUS ... 58

3.10 Connection with the footswitch ... 60 Compatible footswitch ... 60 Connection with the footswitch (MAJ-679) ... 60

3.11 Connection with the external storage device ... 62 Compatible external storage device ... 62 Connection with the external storage device ... 62

Chapter 4 Function Setup ... 65 4.1

Setting outlines ... 65 Required settings ... 65 Settings overview ... 66 Opening the system setting ... 66

4.2

Security settings ... 68 Outline of security settings ... 68 Security setting flow ... 68 Opening security settings ... 69 Switching the security functions ON and OFF ... 72 Setting when login and logout occur ... 79 Setting the functions where security is applied and the operation roles ... 82 Registration and editing of accounts ... 85 Password initialization ... 89

4.3

Setting basic system operation (System setting) ... 92 Outline of System setting ... 92 Opening System setting ... 93 Language, Date and Time ... 95 Operation on freeze of ultrasound image ... 97 Displayed information on monitor display ... 99 Volume ... 102 Setting the keyboard display/connection status ... 103 Setting the connection status of the Ultrasound Center with the video system center ... 107 Setting the video signal ... 109 Setting the functions assigned to the remote switches ... 111 Save/release ... 114

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Setting the DICOM format recording operation ... 116 Registration, editing, and deletion of registered comments ... 117 Setting the operation for starting exam and turning off the power ... 121 Setup on smart settings ... 123

4.4

Summary of system setup ... 126

4.5

Setting the video system center for connection of EU-ME3 ... 134 System setting of the video system center ... 134 Settings for remote operation of the Ultrasound Center ... 135

Chapter 5 Inspection ... 137 5.1

Precautions for inspection ... 137

5.2

Inspection workflow ... 138

5.3

Connection with the ultrasound endoscope/ultrasound cable or the probe driving unit 139 Connection with the ultrasound endoscope/ultrasound cable ... 140 Connection with the probe driving unit ... 141

5.4

Inspection of the power supply ... 141

5.5

Connection with portable memory ... 143 Connecting the portable memory ... 143

5.6

Inspection of the monitor ... 144

5.7

Check of displayed information on monitor ... 145

5.8

Inspection of the ultrasound images ... 147 Inspection of the B mode image ... 147 Inspection of the FLOW mode image ... 148 Inspection of the PW mode image ... 151 Inspection of the CHE mode image ... 152 Inspection of the ELST mode image ... 153

5.9

Inspection of release ... 154

5.10 Inspection of the video system center ... 155 5.11 After inspection ... 156

Chapter 6 Operation ... 157 6.1

Precautions for operation ... 157

6.2

Operation workflow ... 159

6.3

Input and display of patient data ... 160 Input from the Ultrasound Center ... 161 Clear/redisplay patient data ... 165

6.4

Load/save user settings ... 166 How to load user settings ... 166 Load user settings in user settings display ... 166 Load user settings in B MAIN tab ... 170 Saving user settings ... 171

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6.5

Observation of ultrasound images/endoscopic images ... 175 Observation of ultrasound images ... 175 Observation of endoscopic images ... 176 Checking the functions of the footswitch and remote switch connected to the CV-1500 .. 180

6.6

Use measurement function ... 181

6.7

Display comments/pointer on the ultrasound image ... 182 Enter comments ... 182 Clear comments ... 187 Display pointer ... 188

6.8

Save ultrasound image ... 189 Freeze ultrasound image ... 189 Selective display of ultrasound images until just before freezing (CINE REVIEW) ... 190 Storing still images in the internal memory of the Ultrasound Center ... 193 Record still image in ancillary equipment ... 195 Storing of movies in the internal memory of the Ultrasound Center ... 196 Storing of movies in ancillary equipment ... 199 Check the remaining space in the internal memory ... 200

6.9

EXAM END ... 201 EXAM END ... 201 Stopping access to the portable memory ... 202 Removing the portable memory ... 203

6.10 Disconnecting ultrasound endoscope/ultrasound cable or probe driving unit ... 204 Disconnecting ultrasound endoscope/ultrasound cable ... 204 Disconnecting probe driving unit ... 205

Chapter 7 Functions ... 207 7.1

Electronic scanning B mode ... 207 Displaying an observation image in electronic scanning B mode ... 207 Switching to B or THE mode ... 213 Switching the frequency ... 214 Adjust gain ... 215 Adjusting the STC ... 216 Adjusting the display range, position, and direction of the electronic scanning B mode image 218 Adjusting the quality of the electronic scanning B mode image ... 232 Adjusting the focal point of the electronic scanning B mode image ... 238 Adjusting the image processing of the electronic scanning B mode image ... 247 Starting the timer ... 253

7.2

FLOW mode ... 255 Displaying an observation image in FLOW mode ... 255 Switching to COLOR FLOW, POWER FLOW, or H-FLOW ... 258 Switching to dual-screen display or single-screen display ... 261 Adjusting the ROI ... 262 Adjusting the quality of the FLOW mode image ... 267 Adjusting the blood flow detection sensitivity in FLOW mode ... 269

7.3

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PW mode ... 271 EU-ME3 INSTRUCTION MANUAL

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Displaying an observation image in PW mode ... 271 Pulsed Wave Doppler waveform acquisition ... 275 Switching the ultrasound image displayed in PW mode ... 276 Adjusting the position for acquiring the Pulsed Wave Doppler waveform ... 277 Using CINE REVIEW in PW mode ... 280 Adjusting the volume of the Pulsed Wave Doppler waveform ... 281 Adjusting the display in PW mode ... 282 Adjusting the blood flow detection sensitivity in PW mode ... 286 Adjusting the FLOW mode image displayed in PW mode ... 289

7.4

CHE mode ... 290 Opening the CHE mode monitor display ... 291 Switching the CHE-P/CHE-R/C-THE mode ... 295 Adjusting the CHE mode ultrasound output ... 296 Performing a manual flash ... 297 Switching the CHE mode image display ... 298 Starting the timer ... 301 Adjusting image quality of the CHE mode image ... 301 Adjusting focus of the CHE mode image ... 305 Adjusting image processing of the CHE mode image ... 305 Recording/playing back the CHE mode image ... 306

7.5

ELST mode ... 313 Opening the ELST mode monitor display ... 313 Switching to dual-screen display or single-screen display ... 317 Adjusting ROI for ELST ... 318 Adjusting image quality of the ELST mode image ... 318 Adjusting display of the strain graph ... 321 Using the strain graph to adjust the ELST mode image ... 328 Checking the pressurization bar ... 332 Adjusting image processing of the ELST mode image ... 333

7.6

Mechanical radial 2D scanning mode ... 336 Opening the mechanical radial 2D scanning mode monitor display ... 336 Adjusting the display area, location, and direction of the mechanical radial 2D scanning mode image ... 341 Adjusting image quality of the mechanical radial 2D scanning mode image ... 341 Adjusting image quality of the mechanical radial 2D scanning mode image ... 342

7.7

Mechanical radial 3D scanning mode ... 343 Opening the mechanical radial 3D scanning mode monitor display ... 344 Adjusting the helical scanning of mechanical radial 3D scanning mode ... 350 Switching the view of the mechanical radial 3D scanning image ... 353 Adjusting the linear view ... 354 Adjusting display of the oblique view ... 359 Recording a 3D image in a format that can be played back ... 365

7.8

Data management ... 365 Summary of data management ... 365 Opening the database menu ... 366 Searching for data ... 367 Selecting data from search results ... 369 Playing back selected data ... 371 EU-ME3 INSTRUCTION MANUAL

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Copying selected folder/data ... 374 Masking copying selected folder/data ... 377 Moving selected folder/data to an external storage device ... 380 Deleting selected folder/data ... 383 File names and folder configuration ... 386

7.9

Remote operation of EU-ME3/Operation of ancillary equipment ... 389 Operation of the EU-ME3 with a foot switch connected to the EU-ME3 ... 389 Operation of the EU-ME3 with a remote switch for the endoscope ... 390 Operation of the EU-ME3 with a foot switch connected to the CV-1500 ... 391 Recording to a video recorder ... 392

7.10 Operation in combination with a video system center ... 393 Operation of the video system center and ancillary equipment connected to the video system center ... 393

7.11 Maintaining the EU-ME3 ... 401 Opening the maintenance menu ... 401 Displaying past messages ... 403 Backing up settings/images ... 406 Restoring settings/images ... 410 Exporting settings ... 415 Importing settings ... 420 Exporting the setting list ... 426 Displaying product information ... 429 Displaying the grayscale bar for the monitoring test ... 430 Notification of maintenance ... 432 Activating the software option ... 433 Resetting the EU-ME3 ... 433

Chapter 8 Measurement and Analysis ... 439 8.1

Summary of measurement functions ... 439

8.2

Basic measurement functions ... 442 Distance measurement ... 442 Trace measurement ... 445 Surrounding an area with points and measuring area (EDIT) ... 450

8.3

Volume calculation in Mechanical radial 3D scanning mode ... 454 Volume calculation by designating regions on multiple planes ... 454 Interpolating radial planes ... 458 Calculating volume by ellipse approximation ... 459

8.4

Measurement functions in PW mode ... 462 Velocity measurement ... 462 Time measurement ... 464 Velocity ratio measurement ... 466 Time ratio measurement ... 468 Average velocity measurement ... 470 Acceleration measurement ... 472 RI measurement ... 475 Measurement of various values by tracing pulsed wave Doppler waveform ... 477 Flow volume measurement ... 482

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Adjusting trace state ... 484

8.5

TIC analysis ... 493 TIC analysis flow ... 494 Launching TIC analysis ... 495 Starting TIC analysis and displaying the start frame ... 499 Setting the region (ROI) for performing TIC analysis ... 500 Editing ROI ... 503 Changing time period for TIC analysis ... 515 Measuring brightness and time on TIC analysis graph ... 517 Clearing measurement results ... 526 Enter comments ... 528 Saving analysis results ... 530 Loading and saving TIC analysis settings ... 531

8.6

Measurement functions in the ELST mode ... 540 Strain ratio measurement ... 540 Editing ROI for strain ratio measurement ... 544 Displaying the strain histogram ... 550 Saving measurement results ... 553 Playback measurement ... 554

8.7

Measurement functions in the SWQ ... 555 Opening the SWQ monitor display ... 556 Adjusting the location and size of the measured region (SWQ ROI) ... 559 Performing SWQ ... 561 Displaying the measurement result list ... 565 Clearing all measurement results ... 567 Clearing the latest single data measurement result ... 568 Recording the measurement result list in CSV format ... 570 Recording one measurement result in CSV format ... 571 Ending SWQ ... 572

Chapter 9 User settings, TIC analysis settings ... 573 9.1

Summary of user settings ... 573

9.2

User settings management ... 575 Opening the user setting selection screen ... 575 Registering new user settings ... 579 Editing user settings ... 581 Copying user settings ... 583 Deleting user settings ... 586

9.3

User setting list ... 588 Ultrasound endoscope user setting items ... 588 Common menu ... 589 B menu ... 591 FLOW menu ... 596 PW menu ... 598 CHE menu ... 600 ELST menu ... 604 SWQ menu ... 609 EU-ME3 INSTRUCTION MANUAL

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Ultrasound probe user setting items ... 610

9.4

Summary of TIC analysis settings ... 612

9.5

TIC analysis settings management ... 613 Opening the TIC analysis settings screen ... 613 Registering new TIC analysis settings ... 614 Editing TIC analysis settings ... 616 Copying TIC analysis settings ... 618 Deleting TIC analysis settings ... 619

9.6

TIC analysis setting items ... 621 TIC analysis method ... 621 TIC analysis graph display method ... 623

Chapter 10 Reprocessing, Storage, and Disposal ... 625 10.1 Reprocessing ... 625 Surface disinfectant cleaner ... 627 Signs of degradation from reprocessing ... 627 Preparing equipment for reprocessing ... 628 Reprocessing procedure ... 629

10.2 Storage ... 632 10.3 Disposal ... 633

Chapter 11 Troubleshooting ... 635 11.1 Troubleshooting ... 635 11.2 Troubleshooting guide ... 636 11.3 Messages and troubleshooting ... 638 Message classification ... 638 Message for the user to take immediate action ... 639 Malfunction message 1 ... 639 Malfunction message 2 ... 640 Setting confirmation message ... 642

11.4 Returning the Ultrasound Center for repair ... 648

Appendix ... 649 Combination equipment ... 649 System chart ... 649

Specifications ... 652 Environment ... 652 Specifications ... 652

EMC information ... 660 Measurement accuracy ... 668 Equation for the pulsed wave doppler measurements ... 668

Ultrasound transducer surface temperature (internal use) ... 672 License information of Open Source Software ... 673

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Acoustic output safety / table ... 674

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Labels and Symbols

Labels and Symbols Safety-related labels and symbols are marked on the locations shown below. If labels or symbols are missing or illegible, contact Olympus.

 Front panel Blue

Cautions not to connect anything other than dedicated ancillary equipment.

UDI label A label required by some countries’ regulations regarding identification of medical devices also known as Unique Device Identification (UDI).

Type BF applied part

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Labels and Symbols

 Rear panel Product name, Manufacturer name, MD (Medical device), CE marking, Crossed-out wheeled bin symbol

Date of manufacture

Serial Number

Cautions not to connect anything other than dedicated ancillary equipment. Electric rating Equipotential terminal

POWER INPUT 220 – 240 V ˜ 50/60 Hz 340 VA

 Back panel of keyboard Product name, Manufacturer name, CE marking, Crossed-out wheeled bin symbol

Serial Number

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Labels and Symbols

 Keyboard AC adapter (MPU16A-102) Electric rating The rating plate is on the underside of the keyboard AC adapter.

 Back cover of this instruction manual Symbol

Description Manufacturer

Authorized representative in the European Community

Translation

Importer (into European Union)

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Important Information - Please Read Before Use

Important Information - Please Read Before Use

 Intended use/Intended purpose This ultrasound center is intended to be used with Olympus ultrasound endoscopes and Olympus ultrasound probes to observe as indicated within the gastrointestinal (GI) tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree, and urinary tract. Do not use this device for any purpose other than its intended use.

 Contraindications None known.

 Clinical benefit Supports the clinical benefit of connected ultrasound endoscopes and ultrasound probes by providing ultrasound image for users who observe as indicated within the gastrointestinal (GI) tract, biliary and pancreatic ducts and surrounding organs, airways, tracheobronchial tree and urinary tract.

 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 for all equipment that 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, contact Olympus.

 Terms used in this manual Ultrasound endoscope Collective term for Olympus ultrasound gastrovideoscopes, ultrasound gastrointestinal videoscopes, and ultrasound bronchofiberscopes.

Ultrasound probe Collective term for Olympus ultrasound probes for endoscopes and Olympus ultrasound probes for 3D scanning.

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Important Information - Please Read Before Use

Video system center A device that processes signals from an endoscope into signals to display endoscopic images on a monitor.

Video printer A device for printing still images.

Video recorder A device for recording movies.

Medical socket A three-pronged outlet with a dedicated grounding terminal.

Isolation transformer A device that is used to ensure that equipment whose power supply does not have the required insulation safety of medical electrical equipment can maintain the same level of electrical insulation safety as medical electrical equipment.

B mode This function converts the strength of the received ultrasound echoes into the brightness intensity for displaying images. B mode includes electronic scanning B mode (when connected to an ultrasound endoscope), mechanical radial 2D scanning mode, and mechanical radial 3D scanning mode (when connected to an ultrasound probe).

FLOW mode This function performs Doppler processing in the ROI and displays the location where the blood flow was detected in color. FLOW mode includes COLOR FLOW mode, POWER FLOW mode, and H-FLOW mode.

COLOR FLOW mode This mode displays the direction and velocity of the blood flow in color.

POWER FLOW mode This mode displays the strength of the blood flow in color.

H-FLOW mode This mode displays directions and intensity of blood flow in color. It displays in a higher resolution than the POWER FLOW mode.

PW (Pulsed Wave Doppler) mode This function displays the velocity of blood flow (Pulsed Wave Doppler waveform) for a specified ROI in a graph.

THE (Tissue Harmonic Echo) mode This function uses the harmonic component from the tissue for imaging.

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Important Information - Please Read Before Use

CHE (Contrast Harmonic Echo) mode This function uses the harmonic components from the ultrasound contrast agent for imaging.

Fundamental image Reference image in CHE mode.

ELST (Elastography) mode This function displays the elasticity information of tissues in color.

SWQ (Shear Wave Quantification) This function measures the propagation speed of the shear wave generated when the tissue is displaced by acoustic radiation pressure and tries to return to its original state.

Mechanical radial 2D scanning mode This mode displays the B mode image acquired by the ultrasound probe as a two-dimensional image.

Mechanical radial 3D scanning mode This mode displays the B mode image acquired by the ultrasound probe for 3D scanning as a three-dimensional image.

Helical scanning A scanning method of the ultrasound probe for 3D scanning. The ultrasound probe at the tip is moved along the insertion axis while rotating to acquire the ultrasound image in a spiral shape.

GI Gastrointestinal.

RSP Respiratory.

Dual-screen display This function displays two ultrasound images of different modes side by side on the monitor. This is used in PW mode, FLOW mode, ELST, mode, and CHE mode.

Stroke The movement range of helical scanning in the direction of the insertion axis.

Pitch The movement interval of helical scanning in the direction of the insertion axis.

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Important Information - Please Read Before Use

Live Status where ultrasound transmission is performed and the ultrasound image is displayed in real time.

Freeze Status where ultrasound transmission is stopped and the ultrasound image acquired just before is displayed.

Release This function records the image displayed on the monitor as a still image on ancillary equipment (e.g., digital video recorder).

STC (Sensitivity Time Control) This function adjusts the brightness at each distance from the ultrasound transducer.

Focal point This is the convergence point of the ultrasound waves to be transmitted. The resolution is better near the focal point.

s-FOCUS This function reduces the change in resolution with distance from the ultrasound transducer surface (focus-dependent) by combining the received signals obtained from multiple transmissions (aperture synthesis processing).

L.E.reduction (Low Echo reduction) Image processing that suppresses low-level signals in the received signals for reducing noise. Weak signals from the tissue are also suppressed.

Structure enhance Image processing that reduces speckle noise while highlighting the boundaries of structures.

Smoothing Image processing that spatially smoothen ultrasound images.

Persistence Image processing that temporally smoothen ultrasound images.

Echo enhance Image processing that increases the overall contrast of an image while reducing noise.

Brightness enhance Image processing that increases contrast while maintaining the brightness level of the entire image.

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Important Information - Please Read Before Use

Scan line density A measure of the density of data in the scanning direction that generates an ultrasound image.

Frame rate The number of frames of the ultrasound image displayed per second.

ROI (Region Of Interest) The region of interest set by the user.

TIC (Time Intensity Curve) analysis This function allows you to set multiple ROIs for playback images recorded in a dedicated movie in CHE mode, and displays the change over time of the average brightness value (TIC) for each ROI in a graph.

TIC analysis settings This function allows you to save settings for the size of the ROI for TIC analysis and for display of graphs. New entry, Edit, Copy, and Delete operations are available.

User settings This function allows you to save the setting values of parameters for image quality and for the behavior of trackpad gestures for each user and observation purpose. Register New, Edit, Copy, and Delete operations are available.

ALARA (As Low As Reasonably Achievable) This is a guideline for the use of ultrasound on patients. The patient's exposure to ultrasound should be minimized to a level where diagnostic results can still be obtained.

Ultrasound output A measure of the strength of the ultrasound waves output by an ultrasound endoscope or ultrasound probe.

TI (Thermal Index) An indicator of the ease with which ultrasound can cause thermal effects on a patient. The higher the TI, the more likely it is to cause thermal effects on the patient.

MI (Mechanical Index) An indicator of the ease with which ultrasound can cause mechanical effects on a patient. The higher the MI, the more likely it is to cause mechanical stress/damage on the patient.

PIP (Picture-in-Picture) This is one of the methods to display endoscopic and ultrasound images simultaneously on the monitor. It displays a small screen within the screen.

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Important Information - Please Read Before Use

POP (Picture-out-Picture) This is one of the methods to display endoscopic and ultrasound images simultaneously on the monitor. It displays two images side by side.

Operation pointer This is a pointer that is displayed on the monitor and used to perform various operations. The operation pointer changes its shape so that it appears as an arrow pointer (white arrow mark) when used on the menu screen, as a measurement mark (“x” mark) when measuring, and as a cursor mark (blinking square mark) when entering comments.

Pointer A green arrow mark that appears on the ultrasound image when the POINTER key is pressed.

Administrator This is the administrator of the security functions of the Ultrasound Center. When you log in to the Ultrasound Center as an administrator, you can register and edit general users, reset passwords, set protected functions, and perform other operations.

General user This is a user who uses the Ultrasound Center other than the administrator. To use the protected functions, the user needs to enter the ID and password that were set by the administrator.

Tap An action where you touch the trackpad with your fingertip as if tapping it.

Swipe An action performed by stroking the trackpad with a single finger.

Flick An action where you quickly slide your fingertip on the trackpad.

Pinch in An action where you pinch two fingers together on the trackpad.

Pinch out An action where you spread two fingers apart on the trackpad.

Click Pressing the SET key or tapping the trackpad selects the position indicated by the operation pointer on the screen.

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