OLYMPUS

EU-ME1 UNIVERSALENDOSCOPIC ULTRASOUND CENTER Instructions May 2013

Instructions

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File Name: OLYMPUS - GT9117 03 - EU-ME1 UNIVERSALENDOSCOPIC ULTRASOUND CENTER Instructions May 2013 - 2013-05.pdf

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INSTRUCTIONS

UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER

EU-ME1

Contents

Contents Labels and Symbols ...

Important Information - Please Read Before Use...

Intended use ...

Instruction manual ...

User qualifications...

Instrument compatibility ...

Repair and modification ...

Signal words ...

Dangers, warnings, and cautions...

The ALARA principle...

Output display ...

Chapter 1

Checking the Package Contents...

Chapter 2

Nomenclature and Functions ...

2.1

Symbols and descriptions ...

2.2

Front panel...

2.3

Rear panel ...

2.4

Keyboard...

2.5

Rear panel of the keyboard...

2.6

Touch panel ...

2.7

Monitor display...

2D ... 3D ...

66 70

Inspection ...

3.1

Inspection work flow...

3.2

Inspection of the power supply ...

3.3

Inspection of the monitor display ...

3.4

Adjustment of the monitor ...

3.5

Inspection of the ultrasound image ...

Inspection of the B mode image ... Inspection of the color/power flow mode image...

83 84

Power off...

Operation ...

4.1

Operation work flow ...

4.2

Connection of an ultrasound endoscope and probe driving unit...

Ultrasound endoscope...

Chapter 3

3.6

Chapter 4

UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER EU-ME1

Contents

RS adapter ... Probe driving unit ...

94 95

4.3

Patient data ...

4.4

Observation of the ultrasound image ...

4.5

Recording of the observed image ...

100

4.6

Termination of the operation ...

100

Chapter 5

Functions... 101

5.1

Front panel ...

101

ACTIVE switch ...

101

5.2

Keyboard...

103

System setup... 103 Database ... 103 Remove data ... 104 Connector... 106 2D/3D ... 108 Image size ... 109 Move data... 110 Ending the examination... 110 ID input ... 111 Enter comments on the ultrasound image... 111 Clear comments ... 113 Cursor... 114 Save ... 115 Release ... 115 Selecting the ultrasound image (US mode) or endoscopic image (EVIS mode) 116 Picture-in-picture (PinP) ... 118 Option... 119 B mode ... 119 Color flow mode ... 120 Power flow mode... 123 Scroll ... 125 Rotation ... 127 Frequency ... 128 Display range ... 129 Contrast... 131 Gain... 132 Freeze ... 133 Cine review... 134

5.3

Touch panel ...

135

Switching the touch panel display ... Main menu... STC menu ... Image adjustment menu... ROI setup menu ... 3D Setup menu ... 3D Review menu ... Measurement menu ...

135 138 146 149 157 159 160 161

UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER EU-ME1

Contents

5.4

5.5

5.6

5.7

5.8

Comment menu ... PinP (picture-in-picture) menu ... Manual focus menu ...

162 165 167

3D ...

171

3D setup menu ... 3D review menu...

173 179

Measurement functions...

184

Distance measurement... Trace measurement... Edited measurement... Volume calculation... Interpolation for trace measurement... Ellipse approximation... 3D VOL. ... Delete measurement results...

185 188 193 196 199 200 201 202

Database...

203

Save data... Managing image data ... Move data ...

203 208 216

Operation of ancillary equipment (printer, VCR, etc.) ...

218

Image printing using the monochrome video printer... Image printing using the color video printer... Image recording using the VCR... Control of the video system center ... Image recording and playback using the external storage device... Foot switch...

218 219 220 221 230 230

Summary of the image adjustment functions...

230

Classification of functions ...

230

Chapter 6

Fuse Replacement... 232

Chapter 7

Care, Storage, and Disposal... 234

7.1

Care ...

234

7.2

Storage ...

236

7.3

Disposal ...

236

Chapter 8

Installation and Connection ... 237

8.1

Installation work flow...

238

8.2

Installation of the equipment ...

239

Installation on the mobile workstation (WM-NP1, WM-WP1, WM-260, WM-W260, WM-N60)...

240

Monitor ...

241

OEV143 or OEV203 ... OEV181H... OEV191, OEV191H ...

241 243 245

8.4

Keyboard...

247

8.5

Foot switch...

248

8.3

UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER EU-ME1

iii

Contents

8.6

Videocassette recorder (VCR) ...

249

SVO-9500MDP... DSR-20MDP... DVO-1000MD...

249 251 253

Video printer...

255

UP-897MD, P93E... OEP-3, OEP-4...

255 257

Video system center ...

259

CV-190, CV-290 ... CV-180 ... CV-160 ... CV-260 (HDTV), CV-260SL ... CV-260 (SDTV) ... CV-240, CV-140 ...

259 262 264 266 268 270

External storage device ...

272

8.10 Connection to the AC mains power supply ...

273

8.7

8.8

8.9

Chapter 9

Function Setup... 278

9.1

Turning the ultrasound center ON...

278

9.2

System setup ...

279

Basic operations of the system setup... Patient data ... Hospital name ... Display format of date ... Date... Time ... Scale bar ... Real-time comment ... PinP... EVIS/US ... Video signal format... Aspect ... Image setting... Scope switches ... OPTION key ... Trackball upon freeze... Frequency ... Edit registered comments... Data format... SAVE key ... Release time ... Foot release ... Remote (D.FILE, OPTION) ... VCR type ... Surface color setting... Multi-echo boundaries setting ... Reset all settings ... Reset the image adjustment settings ... Summary of settings...

279 281 281 281 282 282 283 284 284 284 285 285 285 286 286 287 287 289 290 290 290 291 291 292 292 293 294 295 296

UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER EU-ME1

Contents

9.3

9.4

Setting of the keyboard ...

300

Setting the DIP switches... Installation of the function template (magnet sheet) ... Adjust the brightness of the LCD touch panel on the keyboard...

300 302 304

Setting the video system center...

304

Chapter 10 Troubleshooting ... 305 10.1 Troubleshooting guide ...

305

10.2 Messages...

308

Message for the user to take immediate action ... Message 1 ... Message 2 ...

309 309 310

Error message ... Confirmation message 1... Confirmation message 2...

311 315 316

10.3 Returning the ultrasound center for repair ...

318

Appendix ... 319 DPR (dual plane reconstruction) examination ...

319

3D examination (oblique display/surface display) ...

320

System chart ...

321

Transportation, storage, and operation environment ...

324

Specifications ...

324

EMC information ...

328

Measurement accuracy...

332

Transducer Surface Temperature (Internal Use) ...

332

Maintenance ... 333

UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER EU-ME1

Contents

UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER EU-ME1

Labels and Symbols

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

 UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER EU-ME1

CE marking Crossed-out wheeled bin’ symbol

Caution, refer to instructions.

Manufacturer name Product name

Serial number

Fuse rating Electric rating Potential equalization terminal

INPUT 220 – 240V 50/60Hz 300VA

 Back cover of this instruction manual Manufacturer Authorized representative in the European Community UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER EU-ME1

Important Information - Please Read Before Use

Important Information - Please Read Before Use Intended use This ultrasound center has been designed to be used with Olympus ultrasound endoscopes, Olympus ultrasound probes or Olympus esophageal ultrasound probes to observe and to store real-time ultrasound images within the gastrointestinal (GI) tract, biliary and pancreatic ducts and surrounding organs, upper 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 of 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, please contact Olympus.

UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER EU-ME1

Important Information - Please Read Before Use

 Terms Used in This Manual Ultrasound endoscope: “Ultrasound endoscope” includes Olympus ultrasound endoscopes, ultrasound gastrovideoscopes, ultrasound probe for esophagus, and ultrasound bronchofibervideoscopes. 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. Wall mains outlet: The wall mains outlet is a wall AC mains power outlet socket having a terminal used exclusively for grounding. Isolation transformer: The isolation transformer is a safety device that is used to isolate noninsulated equipment with potentially high leakage currents to decrease the possibility of electric shock. B mode The B mode displays the brightness of received ultrasound signals. 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. 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. 3D display: In 3D examination, 3D display is achieved by rebuilding multiple, consecutive 2D images acquired by 3D scanning. DPR (dual plane reconstruction) display: DPR (dual plane reconstruction) display is based on linear and radial scanning with the probe driving unit (MAJ-935) and the DPR ultrasound probe.

UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER EU-ME1

Important Information - Please Read Before Use

Dual display: The dual display shows both the radial and linear images at equal sizes during a DPR examination. MPR (multi plane reconstruction) display: The MPR display shows radial images, vertical linear images, horizontal images, and 3D images on a screen divided into four parts during 3D 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. Freeze: The freeze function creates a stationary ultrasound image. Release: The release function is used to capture and record an ultrasound image. External storage device: This is an external USB device with an USB connection. STC (Sensitivity Time Control): STC is the function that controls the sensitivity with respect to the time corresponding to the ultrasound propagation distance. Focus: Focus is the function that improves the resolution in a chosen area of the ultrasound image Line density: The line density refers to the intervals between the ultrasound scanning lines. Increasing the line density improves the lateral resolution but deteriorates the frame rate. Frame correlation: The frame correlation is the function that improves the image smoothness by processing the images of successive frames. Frame rate The frame rate is the speed of displaying ultrasound images in terms of the number of frames updated per second. TX power TX power is the intensity of the ultrasound output from an ultrasound endoscope or probe.

UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER EU-ME1

Important Information - Please Read Before Use

Regions of interest (ROI): Regions of interest are areas set to detect the blood stream by the color flow mode and the power flow mode. As low as reasonably achievable (ALARA): 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. Thermal index (TI): The TI is an indication of the probability of occurring thermal bioeffects: the higher the TI, the greater the probability of thermal bioeffects. Mechanical index (MI): The MI is an indication of the probability of occurring mechanical bioeffects: the higher the MI, the greater the probability of mechanical bioeffects.

UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER EU-ME1

Important Information - Please Read Before Use

User qualifications If there is an official standard on user qualifications to perform endoscopy and endoscopic treatment that is defined by the medical administration or other official institutions, such as academic societies on endoscopy, follow that standard. If there is no official qualification standard, the operator of this instrument must be a physician approved by the medical safety manager of the hospital or person in charge of the department (department of internal medicine, etc.). The physician should be capable of safely performing the planned endoscopy and endoscopic treatment following guidelines set by the academic societies on endoscopy, etc., and considering the difficulty of endoscopy and endoscopic treatment. This manual does not explain or discuss 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 or equipment damage and makes it impossible to obtain the expected functionality. This instrument complies with the EMC standard for medical electrical equipment; 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.

UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER EU-ME1

Important Information - Please Read Before Use

Repair and modification This ultrasound center does not contain any user-serviceable parts. Do not disassemble, modify or attempt to repair it; patient or operator injury, equipment damage and/or the impossibility to obtain the expected functionality can result. Some problems that appear to be malfunctions may be correctable by referring to Chapter 10, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 10, contact Olympus. This instrument is to be repaired by Olympus technicians only.

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.

UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER EU-ME1

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.

•

Because the ultrasound center is a TYPE BF applied part, the ultrasound 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 ultrasound endoscope connected to this ultrasound center to the heart or any area near the heart.  Never allow an EndoTherapy accessory or another ultrasound endoscope applied to or near the heart to come in contact with the ultrasound endoscope connected to this ultrasound center.

•

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 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.

UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER EU-ME1

Important Information - Please Read Before Use

•

To prevent electric shock hazards, the frame of the ultrasound center must be grounded securely and effectively.

•

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

•

To avoid the risk of electric shock and/or fire, inspect the power cord and the plug on a regular basis. Do not use them if they are damaged.

•

When the ultrasound center is used in conjunction with any other electrical device, always ensure that the device has undergone a full safety check.

•

Do not place objects on or near the ventilation grills on the rear panel of the ultrasound center while it is in use.

•

When using a high-frequency EndoTherapy accessory, electrosurgical unit, electrosurgical accessories, or laser accessories, refer to the instruction manuals for the ultrasound endoscopes or ultrasound probes. Otherwise, the patient and/or user may receive an electric shock, fire may be caused, and the ultrasound endoscope or ultrasound probe may be damaged.

•

Do not use the ultrasound center in an environment where electrical noise is generated by electrosurgical equipment, etc.

•

This product may interfere with other medical electronic equipment used in combination. Before use, refer to the Appendix to confirm the compatibility of this instrument with all equipment to be used.

•

Do not use this ultrasound center in locations exposed to strong electromagnetic radiation (for example, in the vicinity of a microwave therapeutic device, MRI, wireless set, short-wave therapeutic device, cellular/portable phone, etc.). Doing so may impair the performance of the ultrasound center.

•

Do not place the product on its side. Otherwise, the ultrasound center may fall and become damaged and/or cause injury.

•

Do not use the ultrasound center under conditions other than those specified in “Operation environment” in the Appendix.

UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER EU-ME1

Important Information - Please Read Before Use

•

Do not use a pointed or hard object to press the keys on the keyboard. This could damage the keyboard.

•

To prevent unnecessary patient exposure to ultrasound radiation, follow the “as-low-as-reasonably achievable” (ALARA) principle when using Olympus ultrasound equipment. Freeze the image whenever you are not actively viewing the “live” ultrasound image. When the equipment is in the FREEZE mode, no ultrasound radiation is emitted.

•

Do not touch the electrical contacts inside the ultrasound center’s socket. Otherwise, the ultrasound center may be damaged.

•

Do not apply excessive force to this ultrasound center and/or other instruments connected. Otherwise, damage and/or malfunction can occur.

•

Do not use the ultrasound center in a dusty environment. Otherwise, damage and/or malfunction can occur.

•

When necessary, clean and vacuum dust the ventilation grills and the filters in the ventilation grills using a vacuum cleaner. Otherwise, the ultrasound center may break down and be damaged by overheating.

•

Be sure that this instrument is not used adjacent to or stacked with other equipment (other than the components of this instrument or system) to avoid electromagnetic interference.

•

When using the ultrasound endoscope or probe in conjunction with an X-ray device, electrical noise may appear in the ultrasound image.

•

Electromagnetic interference may occur to this instrument when it is placed near equipment marked with the following symbol or other portable and mobile RF communications equipment such as cellular phones. If radio interference occurs, mitigation measures may be necessary, such as reorienting or relocating this instrument or shielding the location.

•

This product has a fluorescent lamp that contains mercury. Disposal maybe regulated in your community due to environmental considerations. For disposal or recycling information, please contact your local authorities.

UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER EU-ME1

Important Information - Please Read Before Use

•

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 that an endoscope or electrosurgical accessory can safely be applied to depends on the classification of the equipment to that 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

•

This instrument complies with IEC 60601-2-37 standard and is always observing normal condition. When an abnormal condition is detected, the ultrasound output is stopped by the software.

UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER EU-ME1

Important Information - Please Read Before Use

The ALARA principle ALARA “as low as reasonably achievable” is the guiding principle for the use of diagnostic ultrasound. Qualified medical professionals, using good judgement and insight, determine the exposure that is as low as reasonably achievable. There are no sufficient rules to determine the correct response to every situation. Therefore it is the responsibility of the physician to keep exposure low, bioeffects minimal and images diagnostic. A thorough knowledge of the imaging modes, transducer capability, system setup, and scanning technique is necessary. The imaging mode determines the nature of the ultrasound beam. Transducer capability depends upon transducer frequency, penetration, resolution, and field of view. It is the scanning technique of the qualified ultrasound user along with patient variability that determine the system setting throughout the examination. There are variables that affect the way the physician implements the ALARA principle. These variables include body size, location of the bone relative to the focal point, attenuation in the body, and ultrasound exposure time. Exposure time is an especially useful variable, because it can be controlled by the physician. The ability to limit the exposure over time supports the ALARA principle.

Applying ALARA The system imaging mode selected by the physician is determined by the information required. 2D and 3D imaging provide anatomical information; color flow mode imaging provides information about the velocity of the Doppler signal over time at a given anatomical location; power flow mode imaging provides information about the detectable blood flow using the energy or amplitude strength of the Doppler signal over time at a given anatomical location. Understanding the nature of the imaging mode being used allows the trained physician to apply the ALARA principle. Prudent use of ultrasound implies that the patient exposure to ultrasound is limited to the lowest output for the shortest time necessary to achieve acceptable diagnostic results. The physician uses the system controls to adjust image quality and ultrasound output. The ultrasound center will not exceed an MI (mechanical index) of 1.0, or an ISPTA3 (the derated spatial peak temporal average intensity) of 720 mW/cm2 in any mode. In addition, the ultrasound center will not exceed a TI (thermal index) of 1.0 in any mode.

UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER EU-ME1

Important Information - Please Read Before Use

Output display The ultrasound center and transducer combinations do not exceed either a TI of 1.0 or an MI of 1.0 in any operating mode. Therefore, the output display, which includes TI and MI, is not required and is not displayed.