EU-ME2 Series EVIS EUS ENDOSCOPIC ULTRASOUND CENTER Instructions May 2019

Contents

Contents Labels and Symbols ... 1 Important Information - Please Read Before Use ... 3 Intended use ... 3 Instruction manual ... 3 User qualifications ... 8 Instrument compatibility ... 8 Repair and modification ... 8 Signal words ... 9 Dangers, warnings, and cautions ... 9 Cardiac applications ... 12 ALARA principle ... 13 Reference materials ... 14

Summary of Equipment Functions ... 15 Main function of each Ultrasound Center ... 15 Difference of function about scanning type of electronic scanning ultrasound endoscope . 16

Chapter 1 Checking the Package Contents ... 17 1.1

Checking the package contents ... 17

Chapter 2 Nomenclature and Functions ... 19 2.1

Symbols and descriptions ... 19

2.2

Front panel ... 22

2.3

Rear panel ... 24

2.4

Keyboard (MAJ-1995) ... 26

2.5

Rear panel of the keyboard ... 32

2.6

Side panels ... 33

2.7

Touch panel and monitor display ... 34

Chapter 3 Installation and Connection ... 35 3.1

Precautions for installation and connection ... 35

3.2

Installation workflow ... 37

3.3

Installation of the equipment ... 38 Installation on the mobile workstation (WM-NP2, WM-DP2, WM-NP1, WM-WP1, WM-DP1) .. 38

3.4

Connection with the monitor ... 40 OEV261H ... 40 OEV191H ... 44 OEV191 ... 47

3.5

Keyboard ... 48

3.6

Foot switch ... 49 EU-ME2 PREMIER PLUS / EU-ME2 PREMIER / EU-ME2 INSTRUCTION MANUAL

i

Contents

3.7

Connection of the digital video recorder (DVR) ... 50 IMH-20 ... 50 IMH-10 ... 52 DVO-1000MD ... 53

3.8

Connection with the video printer ... 55 OEP-5 ... 55 OEP-4 ... 57 UP-897MD, P93E ... 59

3.9

Connection with the video system center ... 61 CV-190 and CV-290 ... 61 CV-180 ... 63 CV-160 ... 65 CV-260SL and CV-260 (HDTV) ... 67 CV-260 (SDTV) ... 69

3.10 Connection with the filing system ... 71 3.11 Connection with the external storage device ... 71 3.12 Connection with the AC mains power supply ... 72

Chapter 4 Function Setup ... 77 4.1

List of setting functions ... 77 Setting types ... 77 Setting menus and their outlines ... 78

4.2

Opening/closing the system setup menu ... 79

4.3

General ... 82 Patient data ... 83 Hospital name ... 83 Display format of the date ... 83 Date ... 84 Time ... 85

4.4

Display ... 86 Scale bar ... 87 Clear comment (freeze off) ... 88 Clear measurement (freeze off) ... 88 Select Thermal Index ... 88 Frequency band ... 89 PinP ... 89 EVIS/US ... 90 Pressurization state guide ... 90 Comparison indication of strain ratio ROI ... 91

4.5

Video signal ... 92 Video signal format ... 93 HD aspect ratio ... 94

4.6

Function 1 ... 95 CUSTOM key ... 96 ENHANCE setting ... 98

ii

EU-ME2 PREMIER PLUS / EU-ME2 PREMIER / EU-ME2 INSTRUCTION MANUAL

Contents

Scope switches ... 98

4.7

Image parameter setup (electronic scanning) ... 99 Image settings of B mode ... 100 Image settings of PW mode ... 102 Image settings of CH-EUS mode ... 103

4.8

Function 2 ... 104 Setting items of each tabs ... 106 Setting items of each tabs (SAVE/REC key setting) ... 106

4.9

Save ... 107 Release time ... 107 Still image format (for save) ... 108

4.10 Remote ... 108 Remote ... 110 DVR ... 110 Monitor and keyboard setting (CV combination) ... 111

4.11 Comment ... 111 4.12 Security setup ... 113 Outline of security setup ... 113 Security setup flow ... 114 Security ... 115 Security account ... 117 Administrator ... 120 Database user ... 121 Password setting of the user ... 123

4.13 System reset ... 124 4.14 Reset menu ... 127 Reset the image adjustment settings ... 128 Reset all settings ... 128

4.15 Summary of system setup ... 129 4.16 Setting the keyboard ... 137 Setting the DIP switches ... 138

4.17 Setting the video system center ... 139 CV-260, CV-260SL ... 139 CV-190, CV-290 ... 139

Chapter 5 Inspection ... 141 5.1

Precautions for inspection ... 141

5.2

Inspection workflow ... 142

5.3

Inspection of the power supply ... 143

5.4

Inspection of the monitor display ... 144

5.5

Adjustment of the monitor ... 145

5.6

Inspection of the ultrasound image display ... 145 Inspection of the B mode image ... 145 EU-ME2 PREMIER PLUS / EU-ME2 PREMIER / EU-ME2 INSTRUCTION MANUAL

iii

Contents

Inspection of the FLOW mode image ... 147 Inspection of the PW mode image ... 150 Inspection of the CH-EUS mode image ... 151 Inspection of the ELST mode image ... 152

5.7

Inspection of the video system center ... 153

5.8

Power OFF ... 154

Chapter 6 Operation ... 155 6.1

Precautions for operation ... 155

6.2

Operation workflow ... 157

6.3

Connecting the ultrasound endoscope or probe driving unit ... 158 Ultrasound endoscope ... 159 RS adapter (MAJ-1715) ... 162 Probe driving unit ... 163

6.4

Patient data ... 165

6.5

Observation of ultrasound images ... 168 Observation of B mode images ... 168 Observation of FLOW mode images ... 170 Observation of PW mode images ... 171 Observation of CH-EUS mode images ... 173 Observation of ELST mode images ... 175

6.6

Recording observed images ... 176

6.7

Controlling the video system center ... 177

6.8

Terminating the operation ... 177

Chapter 7 Functions ... 179 7.1

Common functions (front panel) ... 179 ACTIVE switch ... 179 Access STOP switch ... 181

7.2

Common functions (Keyboard) ... 182 ID INPUT ... 182 SYS MENU ... 182 DATABASE ... 183 ADD DATA ... 184 TIMER ... 187 DVR REMOTE ... 188 SOCKET ... 189 2D/3D ... 190 MOVE DATA ... 190 EXAM END ... 191 SAVE/REC ... 191 RELEASE ... 192 Selecting the ultrasound image (US mode) or endoscopic image (EVIS mode) ... 192 CUSTOM ... 194 PIP (Picture-In-Picture) ... 195

iv

EU-ME2 PREMIER PLUS / EU-ME2 PREMIER / EU-ME2 INSTRUCTION MANUAL

Contents

B mode ... 196 FLOW mode ... 197 PW (Pulse Wave Doppler) mode ... 198 CURSOR ... 199 ADD (COMMENT) ... 200 CLEAR (COMMENT) ... 202 I. R. (Image Rotation) ... 202 SCROLL ... 204 DEPTH/RANGE ... 206 GAIN ... 208 ACOUSTIC OUTPUT ... 209 FREEZE ... 210 CINE REVIEW ... 211 CINE REVIEW (Trackball) ... 213

7.3

Mode selection ... 214 Mode selection using keyboard ... 214 Mode selection using mode button on the touch panel ... 215 Mode selection using mode menu on the touch panel ... 216

7.4

Electronic scanning B mode ... 217 Monitor display ... 218 Keyboard operation ... 222 Touch panel operations ... 222 Composition of menus ... 223 MAIN MENU ... 224 IMAGE ADJUST ... 233 STC MENU ... 236 MANUAL FOCUS MENU ... 238 Other touch panel menus ... 242

7.5

Electronic scanning FLOW mode ... 243 Monitor display ... 244 Keyboard operation ... 248 Touch panel operations ... 248 Composition of menus ... 249 FLOW MAIN ... 250 FLOW ADJUST ... 260 MAIN MENU ... 261 IMAGE ADJUST ... 261 Other touch panel menus ... 261

7.6

Electronic scanning PW mode ... 262 Monitor display ... 264 Keyboard operation ... 268 Touch panel operations ... 269 Composition of menus ... 270 PW MAIN ... 271 PW ADJUST ... 283 PW FLOW ... 289 MAIN MENU ... 289 IMAGE ADJUST ... 289 Other touch panel menus ... 289 EU-ME2 PREMIER PLUS / EU-ME2 PREMIER / EU-ME2 INSTRUCTION MANUAL

v

Contents

7.7

Mechanical radial 2D scanning mode ... 290 Monitor display ... 290 Keyboard operation ... 294 Touch panel operations ... 294 Composition of menus ... 295 MAIN MENU ... 296 IMAGE ADJUST ... 297 Other touch panel menus ... 298

7.8

Mechanical radial 3D scanning mode ... 298 Monitor display ... 300 Keyboard operation ... 308 Touch panel operations ... 308 Composition of menus ... 309 3D SETUP ... 310 MAIN MENU ... 320 IMAGE ADJUST ... 320 Other touch panel menus ... 320

7.9

Common touch panel menu ... 321 MEASUREMENT ... 321 COMMENT ... 322 PIP ... 325

7.10 Electronic scanning CH-EUS mode ... 329 Selecting the electronic scanning CH-EUS mode ... 330 Monitor display ... 332 Keyboard operations ... 336 Touch panel operations ... 338 Composition of menus of CH-B mode ... 339 Composition of menus of CH-COLOR mode ... 340 Electronic scanning CH-B mode ... 341 CH-EUS MAIN ... 341 CH-EUS ADJUST ... 350 MAIN MENU ... 352 Electronic scanning CH-COLOR mode ... 352 Selecting the electronic scanning CH-COLOR mode ... 352 CH-EUS MAIN (CH-COLOR) ... 353 CH-EUS ADJUST (CH-COLOR) ... 354 CH-EUS COLOR ... 355 MAIN MENU (CH-COLOR) ... 355 Other touch panels ... 355

7.11 Electronic scanning ELST mode ... 356 Selecting the ELST mode ... 356 Monitor display ... 358 Keyboard operations ... 362 Touch panel operations ... 362 Composition of menus ... 363 ELST MAIN menu ... 364 STRAIN GRAPH ... 367 Set up of strain graph ... 368 Pressurization bar ... 374

vi

EU-ME2 PREMIER PLUS / EU-ME2 PREMIER / EU-ME2 INSTRUCTION MANUAL

Contents

MAIN MENU ... 375 IMAGE ADJUST ... 375 Other touch panel menus ... 375

7.12 Data management ... 376 Summary of data management ... 376 SAVE/REC data ... 377 Saving TIC movie ... 384 Managing image data ... 386 Installing the portable memory ... 387 Removing the portable memory ... 388 Selecting the data management function ... 389 Database menu function ... 391 Open ... 394 Copy ... 396 Move ... 399 Delete ... 401 TIC analysis ... 402 Password setup ... 402 Move data ... 403

7.13 Operation of ancillary equipment (printer, DVR, etc.) ... 406 Image printing using the monochrome video printer ... 406 Image printing using the color video printer ... 407 Image saving using the portable memory via CV-190/290 ... 408 Image recording using the DVR ... 409 Controlling the external storage device ... 410 Controlling the foot switch ... 410

7.14 Control of the video system center ... 411 Touch panel menus for controlling the video system center ... 412 Controlling the color video printer from the video system center ... 423 Controlling the DVR from the video system center ... 425

7.15 Summary of image adjustments ... 427 Classification of available functions ... 427

Chapter 8 Measurement and Analysis ... 431 8.1

Summary of measurement functions ... 431

8.2

Basic measurement ... 434 Distance measurement ... 435 Trace measurement ... 441 Edit measurement ... 448 Clearing measurements ... 450

8.3

Measurements in the 3D mode ... 451 Volume calculation ... 451 Interpolation for trace measurement ... 455 Ellipse approximation ... 455

8.4

Measurement of saved still images ... 457

8.5

Measurements in the PW mode ... 458 EU-ME2 PREMIER PLUS / EU-ME2 PREMIER / EU-ME2 INSTRUCTION MANUAL

vii

Contents

Velocity measurement ... 460 Time measurement ... 463 Average velocity measurement ... 468 Velocity ratio measurement ... 470 Time ratio measurement ... 472 Acceleration measurement ... 476 PW trace measurement ... 479 PW MEASUREMENT MENU ... 487

8.6

Measurement in the ELST mode ... 494 Strain ratio measurement ... 496 Modifying the strain measurement ... 500

8.7

TIC analysis ... 506 TIC analysis flow ... 506 Launching TIC analysis ... 507 TIC analysis menu ... 509 Setting the TIC analysis frames ... 511 ROI setting tools for TIC analysis ... 513 ROI locations in each frame for TIC analysis ... 517 TIC analysis result display ... 520 TIC analysis result setting menu ... 527

Chapter 9 Care, Storage, and Disposal ... 531 9.1

Care ... 531

9.2

Storage ... 533

9.3

Disposal ... 533

Chapter 10 Troubleshooting ... 535 10.1 Troubleshooting ... 535 10.2 Troubleshooting guide ... 536 10.3 Messages and troubleshooting ... 538 Message classification ... 538 Message for the user to take immediate action ... 539 Malfunction message 1 ... 539 Malfunction message 2 ... 540 Setting confirmation message ... 542 Execution confirmation message ... 546 End confirmation messages ... 547

10.4 Returning the Ultrasound Center for repair ... 548

Appendix ... 549 System chart ... 549 Transportation, storage, and operation environment ... 552 Specifications ... 552 EMC information ... 559

viii

EU-ME2 PREMIER PLUS / EU-ME2 PREMIER / EU-ME2 INSTRUCTION MANUAL

Contents

Measurement accuracy ... 565 Equation for the pulse wave doppler measurement ... 568 Transducer surface temperature (internal use) ... 571 License information of Open Source Software ... 572 GNU ... 572 Others ... 573

End User License Agreement of Open Source Software modules (English) ... 574 GNU GENERAL PUBLIC LICENSE Version 2, June 1991 ... 574 GNU GENERAL PUBLIC LICENSE Version 2 with Exception ... 581 GNU LESSER GENERAL PUBLIC LICENSE Version 2.1, February 1999 ... 582 Others ... 592

Acoustic output safety / table ... 593 Index ... 629

EU-ME2 PREMIER PLUS / EU-ME2 PREMIER / EU-ME2 INSTRUCTION MANUAL

ix

Contents

x

EU-ME2 PREMIER PLUS / EU-ME2 PREMIER / EU-ME2 INSTRUCTION MANUAL

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

Refer to the instruction manual.

UDI label The UDI label is required by some countries’ regulations regarding the identification of a medical device also known as Unique Device Identification (UDI).

ESD marking Indicates a potential failure due to electrostatic discharge. Do not touch the terminal pins directly with your hands.

EU-ME2 PREMIER PLUS / EU-ME2 PREMIER / EU-ME2 INSTRUCTION MANUAL

1

Labels and Symbols

 Rear panel Product name EVIS EUS ENDOSCOPIC ULTRASOUND CENTER MODEL OLYMPUS EU-ME2 EVIS EUS ENDOSCOPIC ULTRASOUND CENTER MODEL OLYMPUS EU-ME2 PREMIER EVIS EUS ENDOSCOPIC ULTRASOUND CENTER MODEL OLYMPUS EU-ME2 PREMIER PLUS

Serial number

Manufacturer name CE marking Refer to the instruction manual. Crossed-out wheeled bin symbol

Electric rating Potential equalization terminal

INPUT: 220–240 V 50/60 Hz, 370 VA

 Back cover of this instruction manual Symbol

Description Manufacturer

Authorized representative in the European Community

2

EU-ME2 PREMIER PLUS / EU-ME2 PREMIER / EU-ME2 INSTRUCTION MANUAL

Important Information - Please Read Before Use

Important Information - Please Read Before Use

 Intended use This Ultrasound Center is intended to be used with Olympus ultrasound endoscopes, Olympus ultrasound probes or Olympus esophageal ultrasound probes to observe and to store real-time ultrasound images and indicated for use 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.

 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: “Ultrasound endoscope” includes ultrasound gastrovideoscopes and ultrasound bronchofibervideoscopes.

Ultrasound probe: Generic name indicating the Olympus ultrasound probe for endoscope or ultrasound probe for 3D scanning.

Video system center: The video system center is a device that converts video signals from an endoscope into signals to display images on the monitor.

Video printer: The video printer is a device that prints the frozen video image.

Wall mains outlet: The wall mains outlet is a wall AC mains power outlet socket having an exclusive terminal for grounding.

EU-ME2 PREMIER PLUS / EU-ME2 PREMIER / EU-ME2 INSTRUCTION MANUAL

3

Important Information - Please Read Before Use

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.

B mode The B mode displays the brightness of received ultrasound signals.

FLOW mode The FLOW mode displays the blood flow information calculated with Doppler processing. The FLOW mode includes the COLOR FLOW, POWER FLOW, and H-FLOW modes.

COLOR FLOW mode The COLOR FLOW mode displays velocity information calculated by Doppler processing.

POWER FLOW mode The POWER FLOW mode displays amplitude information calculated by Doppler processing.

H-FLOW (High Resolution Flow) mode The H-FLOW mode displays amplitude information in a higher resolution than the POWER FLOW mode. It also displays directions of the blood flow in color.

PW (Pulse Wave Doppler) mode PW mode displays the blood flow information of only the regions of interest.

THE (Tissue Harmonic Echo) mode Imaging method that uses the harmonic component bounced back from the tissue.

CH-EUS (Contrast Harmonic EUS) mode Mode for imaging using the harmonic component from the ultrasound contrast agent. The CH-EUS mode includes two modes; the CH-B mode and the CH-COLOR mode.

CH-B (Contrast Harmonic B) mode Mode for viewing the harmonic component from the ultrasound contrast agent using dedicated B mode images.

CH-COLOR (Contrast Harmonic COLOR) mode Mode for viewing the harmonic component from the ultrasound contrast agent by superimposing a color image on a fundamental image.

Fundamental image Reference image in the CH-EUS mode.

4

EU-ME2 PREMIER PLUS / EU-ME2 PREMIER / EU-ME2 INSTRUCTION MANUAL

Important Information - Please Read Before Use

ELST (Elastography) mode Mode for displaying the relative elasticity information of a tissue using color images.

2D scanning 2D scanning is an examination displaying the ultrasound images in two dimensions.

3D scanning 3D scanning is an examination displaying the ultrasound images in three dimensions.

Helical scanning Ultrasound probe is moved linearly and rotated simultaneously to acquire ultrasound images with spiral scanning.

3D display In 3D examination, 3D display is achieved by rebuilding multiple, consecutive 2D images acquired by 3D scanning.

DPR (Dual Plane Reconstruction) DPR display is based on helical and radial scanning with the probe driving unit and the ultrasound probe for 3D scanning.

MPR (Multi Plane Reconstruction) The MPR display shows radial images, vertical helical images, horizontal images, and oblique images on a screen divided into four parts during 3D examination.

GI Gastrointestinal.

PB Pancreas and bile duct.

RSP Respiratory organ (bronchus).

Dual-screen display It is possible to select the dual-screen display for displaying the B mode and FLOW mode simultaneously on the screen split into two areas or to select the single-screen display for overlapping the FLOW mode on the B mode. The images that can be viewed in the single-screen display and dual-screen display are variable depending on the mode.

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

EU-ME2 PREMIER PLUS / EU-ME2 PREMIER / EU-ME2 INSTRUCTION MANUAL

5

Important Information - Please Read Before Use

Pitch The pitch is the interval of movement in helical scanning.

Freeze The freeze function creates a stationary ultrasound image and the ultrasound transmission is stopped.

Release The release function is used to capture and record an ultrasound image.

STC (Sensitivity Time Control) Indication of the brightness adjustment condition at each distance from the ultrasound transducer.

Focus Focus is the function that improves the resolution in a chosen area of the ultrasound image.

ENHANCE ENHANCE is the function that executes the image enhancement specialized for the B mode images.

COMPOUND COMPOUND is the function that provides a superimposed image obtained from ultrasound signals sent from different angles.

Frame rate The numbers displayed on the screen represent the frames updated per second, which are rough numbers for information.

ROI It is regions of interest.

TIC (Time Intensity Curve) analysis When multiple ROI are set during playback of a movie recorded in the CH-B mode and THE mode, the change over time of the average brightness of each ROI can be displayed in the graphic forms.

ALARA (As Low As Reasonably Achievable) The ALARA is the guiding principle of ultrasound use, which states that you should keep patient exposure to ultrasound radiation as low as reasonably achievable for diagnostic results.

6

EU-ME2 PREMIER PLUS / EU-ME2 PREMIER / EU-ME2 INSTRUCTION MANUAL

Important Information - Please Read Before Use

Acoustic power Acoustic power is the intensity of the ultrasound output from an ultrasound endoscope or probe.

TI (Thermal Index) The TI is an indication of the probability of occurring thermal bioeffects: the higher the TI, the greater the probability of thermal bioeffects.

MI (Mechanical Index) The MI is an indication of the probability of occurring mechanical bioeffects: the higher the MI, the greater the probability of mechanical bioeffects.

Administrator A person who manages the Ultrasound Center.

Database user A person who opens, copies, or moves data stored in the Ultrasound Center.

Arrow pointer Displays the green arrow mark by CURSOR key.

Cursor Displays the white arrow mark on the menu display or white blinking box cursor in comment mode.

EU-ME2 PREMIER PLUS / EU-ME2 PREMIER / EU-ME2 INSTRUCTION MANUAL

7

Important Information - Please Read Before Use

 User qualifications If there is an official standard on the qualification of endoscopy and endoscopic treatment that is defined by the medical administration or other official institutions such as the academic society on endoscopy, follow the standard. If there is no official qualification standard, the operator of the Ultrasound Center must be a physician approved by the medical safety manager of the hospital or person in charge of the department (department of urology, etc.). The medical safety manager of the hospital or person in charge of the department should select a physician who is performing the planned endoscopic treatment safely by following the official guidelines set by the academic society of endoscopy, etc.

 Instrument compatibility Refer to “System chart” on page 549 to confirm that the Ultrasound Center is compatible with the ancillary equipment being used. Using incompatible equipment can result in patient injury or equipment damage and makes it impossible to obtain the expected functionality. This instrument complies with the EMC standard for medical electrical equipment, edition 4 (IEC 60601-1-2: 2014). When connecting to an instrument that complies with a previous edition of the EMC standard for medical electrical equipment edition, the EMC characteristics could be vulnerable. The Ultrasound Center complies with the Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment; edition 2.1 (IEC 60601-2-37: 2007+A1: 2015). However, when connected with an instrument that complies with the Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment; edition 2 (IEC 60601-2-37: 2007), the whole system complies with edition 2.

 Repair and modification Never attempt to disassemble or modify the instrument, as this may result in patient or operator injury as well as damage to the equipment. In addition, the functionality of the instrument can not be guaranteed. If the instrument seems to require repair, first take measures by referring to Chapter 10, “Troubleshooting”. If the problem still persists, contact Olympus. This instrument is to be repaired by Olympus technicians only. Olympus is not liable for any injury or damage that occurs as a result of repairs attempted by non-Olympus personnel.

8

EU-ME2 PREMIER PLUS / EU-ME2 PREMIER / EU-ME2 INSTRUCTION MANUAL

Important Information - Please Read Before Use

 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

Indicates additional helpful information.

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

DANGER • 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 in a patient examination, do not allow metal parts of the ultrasound 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. • Never install and 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 gases are present in the atmosphere;  Flammable liquids are near. An explosion or a fire may result because the video system center is not explosion-proof. • Use only a grounded wall mains outlet when connecting the Ultrasound Center. Failure to do so may cause an electric shock or a fire.

EU-ME2 PREMIER PLUS / EU-ME2 PREMIER / EU-ME2 INSTRUCTION MANUAL

9