EU-ME2 Series EVIS EUS ENDOSCOPIC ULTRASOUND CENTER Instructions April 2014

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 ... 36

3.3

Installation of the equipment ... 37 Installation on the mobile workstation (WM-NP2, WM-DP2, WM-NP1, WM-WP1, WM-DP1) .. 37

3.4

Connection with the monitor ... 39 OEV261H ... 39 OEV191H ... 43 OEV191 ... 46

3.5

Keyboard ... 47

3.6

Foot switch ... 48 EU-ME2 PREMIER PLUS / EU-ME2 PREMIER / EU-ME2 INSTRUCTION MANUAL

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3.7

Connection of the digital video recorder (DVR) ... 49 IMH-20 ... 49 IMH-10 ... 51 DVO-1000MD ... 52

3.8

Connection with the video printer ... 54 OEP-5 ... 54 OEP-4 ... 56 UP-897MD, P93E ... 58

3.9

Connection with the video system center ... 60 CV-190 and CV-290 ... 60 CV-180 ... 62 CV-160 ... 64 CV-260SL and CV-260 (HDTV) ... 66 CV-260 (SDTV) ... 68

3.10 Connection with the filing system ... 70 3.11 Connection with the external storage device ... 70 3.12 Connection with the AC mains power supply ... 71

Chapter 4 Function Setup ... 75 4.1

List of setting functions ... 75 Setting types ... 75 Setting menus and their outlines ... 76

4.2

Opening/closing the system setup menu ... 77

4.3

General ... 80 Patient data ... 81 Hospital name ... 81 Display format of the date ... 81 Date ... 82 Time ... 83

4.4

Display ... 84 Scale bar ... 85 Clear comment (freeze off) ... 86 Clear measurement (freeze off) ... 86 Select Thermal Index ... 86 Frequency band ... 87 PinP ... 87 EVIS/US ... 88 Pressurization state guide ... 88 Comparison indication of strain ratio ROI ... 89

4.5

Video signal ... 90 Video signal format ... 91 HD aspect ratio ... 92

4.6

Function 1 ... 93 CUSTOM key ... 94 ENHANCE setting ... 96

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Scope switches ... 96

4.7

Image parameter setup (electronic scanning) ... 97 Image settings of B mode ... 98 Image settings of PW mode ... 100 Image settings of CH-EUS mode ... 101

4.8

Function 2 ... 102 Setting items of each tabs ... 104 Setting items of each tabs (SAVE/REC key setting) ... 104

4.9

Save ... 105 Release time ... 105 Still image format (for save) ... 106

4.10 Remote ... 106 Remote ... 108 DVR ... 108 Monitor and keyboard setting (CV combination) ... 109

4.11 Comment ... 109 4.12 Security setup ... 111 Outline of security setup ... 111 Security setup flow ... 112 Security ... 113 Security account ... 115 Administrator ... 118 Database user ... 119 Password setting of the user ... 121

4.13 System reset ... 122 4.14 Reset menu ... 125 Reset the image adjustment settings ... 126 Reset all settings ... 126

4.15 Summary of system setup ... 127 4.16 Setting the keyboard ... 135 Setting the DIP switches ... 136

4.17 Setting the video system center ... 137 CV-260, CV-260SL ... 137 CV-190, CV-290 ... 137

Chapter 5 Inspection ... 139 5.1

Precautions for inspection ... 139

5.2

Inspection workflow ... 140

5.3

Inspection of the power supply ... 141

5.4

Inspection of the monitor display ... 142

5.5

Adjustment of the monitor ... 143

5.6

Inspection of the ultrasound image display ... 143 Inspection of the B mode image ... 143 EU-ME2 PREMIER PLUS / EU-ME2 PREMIER / EU-ME2 INSTRUCTION MANUAL

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Inspection of the FLOW mode image ... 145 Inspection of the PW mode image ... 148 Inspection of the CH-EUS mode image ... 149 Inspection of the ELST mode image ... 150

5.7

Inspection of the video system center ... 151

5.8

Power OFF ... 152

Chapter 6 Operation ... 153 6.1

Precautions for operation ... 153

6.2

Operation workflow ... 155

6.3

Connecting the ultrasound endoscope or probe driving unit ... 156 Ultrasound endoscope ... 157 RS adapter (MAJ-1715) ... 160 Probe driving unit ... 161

6.4

Patient data ... 163

6.5

Observation of ultrasound images ... 166 Observation of B mode images ... 166 Observation of FLOW mode images ... 168 Observation of PW mode images ... 169 Observation of CH-EUS mode images ... 171 Observation of ELST mode images ... 173

6.6

Recording observed images ... 174

6.7

Controlling the video system center ... 175

6.8

Terminating the operation ... 175

Chapter 7 Functions ... 177 7.1

Common functions (front panel) ... 177 ACTIVE switch ... 177 Access STOP switch ... 179

7.2

Common functions (Keyboard) ... 180 ID INPUT ... 180 SYS MENU ... 180 DATABASE ... 181 ADD DATA ... 182 TIMER ... 185 DVR REMOTE ... 186 SOCKET ... 187 2D/3D ... 188 MOVE DATA ... 188 EXAM END ... 189 SAVE/REC ... 189 RELEASE ... 190 Selecting the ultrasound image (US mode) or endoscopic image (EVIS mode) ... 190 CUSTOM ... 192 PIP (Picture-In-Picture) ... 193

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B mode ... 194 FLOW mode ... 195 PW (Pulse Wave Doppler) mode ... 196 CURSOR ... 197 ADD (COMMENT) ... 198 CLEAR (COMMENT) ... 200 I. R. (Image Rotation) ... 200 SCROLL ... 202 DEPTH/RANGE ... 204 GAIN ... 206 ACOUSTIC OUTPUT ... 207 FREEZE ... 208 CINE REVIEW ... 209 CINE REVIEW (Trackball) ... 211

7.3

Mode selection ... 212 Mode selection using keyboard ... 212 Mode selection using mode button on the touch panel ... 213 Mode selection using mode menu on the touch panel ... 214

7.4

Electronic scanning B mode ... 215 Monitor display ... 216 Keyboard operation ... 220 Touch panel operations ... 220 Composition of menus ... 221 MAIN MENU ... 222 IMAGE ADJUST ... 231 STC MENU ... 234 MANUAL FOCUS MENU ... 236 Other touch panel menus ... 240

7.5

Electronic scanning FLOW mode ... 241 Monitor display ... 242 Keyboard operation ... 246 Touch panel operations ... 246 Composition of menus ... 247 FLOW MAIN ... 248 FLOW ADJUST ... 258 MAIN MENU ... 259 IMAGE ADJUST ... 259 Other touch panel menus ... 259

7.6

Electronic scanning PW mode ... 260 Monitor display ... 262 Keyboard operation ... 266 Touch panel operations ... 267 Composition of menus ... 268 PW MAIN ... 269 PW ADJUST ... 281 PW FLOW ... 287 MAIN MENU ... 287 IMAGE ADJUST ... 287 Other touch panel menus ... 287 EU-ME2 PREMIER PLUS / EU-ME2 PREMIER / EU-ME2 INSTRUCTION MANUAL

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7.7

Mechanical radial 2D scanning mode ... 288 Monitor display ... 288 Keyboard operation ... 290 Touch panel operations ... 290 Composition of menus ... 291 MAIN MENU ... 292 IMAGE ADJUST ... 293 Other touch panel menus ... 294

7.8

Mechanical radial 3D scanning mode ... 294 Monitor display ... 296 Keyboard operation ... 304 Touch panel operations ... 304 Composition of menus ... 305 3D SETUP ... 306 MAIN MENU ... 316 IMAGE ADJUST ... 316 Other touch panel menus ... 316

7.9

Common touch panel menu ... 317 MEASUREMENT ... 317 COMMENT ... 318 PIP ... 321

7.10 Electronic scanning CH-EUS mode ... 325 Selecting the electronic scanning CH-EUS mode ... 326 Monitor display ... 328 Keyboard operations ... 332 Touch panel operations ... 334 Composition of menus of CH-B mode ... 335 Composition of menus of CH-COLOR mode ... 336 Electronic scanning CH-B mode ... 337 CH-EUS MAIN ... 337 CH-EUS ADJUST ... 346 MAIN MENU ... 348 Electronic scanning CH-COLOR mode ... 348 Selecting the electronic scanning CH-COLOR mode ... 348 CH-EUS MAIN (CH-COLOR) ... 349 CH-EUS ADJUST (CH-COLOR) ... 350 CH-EUS COLOR ... 351 MAIN MENU (CH-COLOR) ... 351 Other touch panels ... 351

7.11 Electronic scanning ELST mode ... 352 Selecting the ELST mode ... 352 Monitor display ... 354 Keyboard operations ... 358 Touch panel operations ... 358 Composition of menus ... 359 ELST MAIN menu ... 360 STRAIN GRAPH ... 363 Set up of strain graph ... 364 Pressurization bar ... 370

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MAIN MENU ... 371 IMAGE ADJUST ... 371 Other touch panel menus ... 371

7.12 Data management ... 372 Summary of data management ... 372 SAVE/REC data ... 373 Saving TIC movie ... 380 Managing image data ... 382 Installing the portable memory ... 383 Removing the portable memory ... 384 Selecting the data management function ... 385 Database menu function ... 387 Open ... 390 Copy ... 391 Move ... 394 Delete ... 396 TIC analysis ... 397 Password setup ... 397 Move data ... 398

7.13 Operation of ancillary equipment (printer, DVR, etc.) ... 401 Image printing using the monochrome video printer ... 401 Image printing using the color video printer ... 402 Image saving using the portable memory via CV-190/290 ... 403 Image recording using the DVR ... 404 Controlling the external storage device ... 405 Controlling the foot switch ... 405

7.14 Control of the video system center ... 406 Touch panel menus for controlling the video system center ... 407 Controlling the color video printer from the video system center ... 418 Controlling the DVR from the video system center ... 420

7.15 Summary of image adjustments ... 422 Classification of available functions ... 422

Chapter 8 Measurement and Analysis ... 425 8.1

Summary of measurement functions ... 425

8.2

Basic measurement ... 428 Distance measurement ... 429 Trace measurement ... 435 Edit measurement ... 442 Clearing measurements ... 444

8.3

Measurements in the 3D mode ... 445 Volume calculation ... 445 Interpolation for trace measurement ... 449 Ellipse approximation ... 449

8.4

Measurement of saved still images ... 451

8.5

Measurements in the PW mode ... 452 EU-ME2 PREMIER PLUS / EU-ME2 PREMIER / EU-ME2 INSTRUCTION MANUAL

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Velocity measurement ... 454 Time measurement ... 457 Average velocity measurement ... 462 Velocity ratio measurement ... 464 Time ratio measurement ... 466 Acceleration measurement ... 470 PW trace measurement ... 473 PW MEASUREMENT MENU ... 481

8.6

Measurement in the ELST mode ... 488 Strain ratio measurement ... 490 Modifying the strain measurement ... 494

8.7

TIC analysis ... 500 TIC analysis flow ... 500 Launching TIC analysis ... 501 TIC analysis menu ... 502 Setting the TIC analysis frames ... 504 ROI setting tools for TIC analysis ... 506 ROI locations in each frame for TIC analysis ... 510 TIC analysis result display ... 513 TIC analysis result setting menu ... 520

Chapter 9 Care, Storage, and Disposal ... 523 9.1

Care ... 523

9.2

Storage ... 525

9.3

Disposal ... 525

Chapter 10 Troubleshooting ... 527 10.1 Troubleshooting ... 527 10.2 Troubleshooting guide ... 528 10.3 Messages and troubleshooting ... 530 Message classification ... 530 Message for the user to take immediate action ... 531 Malfunction message 1 ... 531 Malfunction message 2 ... 532 Setting confirmation message ... 534 Execution confirmation message ... 538 End confirmation messages ... 539

10.4 Returning the Ultrasound Center for repair ... 540

Appendix ... 541 System chart ... 541 Transportation, storage, and operation environment ... 544 Specifications ... 544 EMC information ... 551

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Measurement accuracy ... 556 Equation for the pulse wave doppler measurement ... 559 Transducer surface temperature (internal use) ... 562 License information of Open Source Software ... 563 GNU ... 563 Others ... 564

End User License Agreement of Open Source Software modules (English) ... 565 GNU GENERAL PUBLIC LICENSE Version 2, June 1991 ... 565 GNU GENERAL PUBLIC LICENSE Version 2 with Exception ... 572 GNU LESSER GENERAL PUBLIC LICENSE Version 2.1, February 1999 ... 573 Others ... 583

Acoustic output safety / table ... 584 Maintenance ... 634 Index ... 637

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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

Refer to the instruction manual.

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

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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

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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 a 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.

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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.

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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.

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).

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Important Information - Please Read Before Use

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.

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 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.

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Important Information - Please Read Before Use

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.

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 manage the Ultrasound Center.

Database user A person who open, copy, or move 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.

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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 safety by following the official guidelines set by the academic society of endoscopy, etc.

 Instrument compatibility Refer to “System chart” on page 541 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. The Ultrasound Center complies with the EMC standard for medical electrical equipment; edition 3 (IEC 60601-1-2: 2007), edition 2 (IEC 60601-1-2: 2001). However, when connected with an instrument that complies with the EMC standard for medical electrical equipment; edition 1 (IEC 60601-1-2: 1993), the whole system complies with edition 1.

 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.

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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.

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