CV-190 EVIS EXERA III Video System Center Instructions March 2021

Contents

Contents Labels and Symbols ... 1 Important Information - Please Read Before Use ... 3 Intended use/Intended purpose ... 3 Contraindications ... 3 Clinical benefit ... 3 Applicability of endoscopy and endoscopic treatment ... 4 Instruction manual ... 5 User qualifications ... 8 Instrument compatibility ... 8 Repair and modification ... 8 Signal words ... 9 Dangers, warnings, and cautions ... 9 Security ... 13 Cardiac applications ... 14

Summary of Equipment Functions ... 15 Displaying the endoscopic images on the monitor ... 15 Optical-digital observations ... 15 Adjusting the endoscopic images ... 16 Recording images ... 16 Entering patient data ... 17 Customizing the operations ... 17 Operation of ancillary equipment ... 17

Chapter 1 Checking the Package Contents ... 19 1.1

Checking the package contents ... 19

Chapter 2 Nomenclature and Functions ... 21 2.1

Symbols and descriptions ... 21

2.2

Front panel ... 24

2.3

Rear panel ... 26

2.4

Keyboard ... 28

2.5

Side panels ... 34

2.6

Monitor ... 35 Endoscopic image screen ... 35 Setting display (e.g.) ... 37

Chapter 3 Installation and Connection ... 39 3.1

Precautions for installation and connection ... 39

3.2

Installation workflow ... 40

3.3

Installation of the equipment ... 41 Installation on the mobile workstation (WM-NP2, WM-DP2, WM-NP1, or WM-WP1) ... 42 CV-190 INSTRUCTION MANUAL

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Installation in another location ... 43

3.4

Fitting of accessories ... 44 Scope cable holder (MAJ-1466) ... 44 White cap set (MAJ-941) ... 45

3.5

Connection of the light source ... 47 Compatible light sources ... 47 CLV-190 ... 48 CLV-S190, CLV-180, CLV-S40Pro, CLE-165 ... 50

3.6

Connection of the monitor ... 51 Compatible monitors ... 51 OEV261H ... 52 OEV191H ... 54 OEV181H ... 58 OEV191 ... 60

3.7

Connection of the keyboard ... 62

3.8

Connection of the video recorder (DVR) ... 64 Compatible video recorders ... 64 IMH-20 ... 64 IMH-10 ... 66 Other DVRs ... 68

3.9

Connection of the video printer ... 71 Compatible video printers ... 71 OEP-5 ... 72 OEP-4 ... 74 OEP-3, or another video printer ... 76

3.10 Connection of endoscope position detecting unit ... 78 Compatible endoscope position detecting units ... 78 UPD-3 ... 78 UPD ... 80

3.11 Connection of the ultrasound center ... 82 Compatible ultrasound centers ... 82 EU-ME1 ... 82 EU-M60, EU-MA ... 84 EU-C60 ... 86

3.12 Connection of the foot switch ... 87 3.13 Connection of the flushing pump ... 88 Compatible flushing pumps ... 88

3.14 Connection of the Endoscopic CO2 regulation unit ... 90 3.15 Connection of the server ... 92 3.16 Installation of the CV interface converter (MAJ-1916) ... 92 3.17 Connection of equipment having the LINK-IN and LINK-OUT terminals ... 95 CLV-190 ... 96 CLV-S190, CLV-180, CLV-S40Pro, CLE-165 ... 98

3.18 Connection to the AC mains power supply ... 100

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When the mobile workstation (WM-NP2, WM-DP2, WM-NP1, or WM-WP1) is used ... 101 When a mobile workstation other than the WM-NP2, WM-DP2, WM-NP1, or WM-WP1 is used or when no mobile workstation is used ... 102

Chapter 4 Function setup ... 105 4.1

Setup list ... 105

4.2

Basic operation of the system setup ... 106 Displaying the system setup screen ... 106 Editing the system setup ... 109 Saving the system setup to the portable memory ... 111 Loading the system setup from the portable memory ... 112

4.3

System setup (system) ... 113 “Date/comment” tab ... 114 “Operation” tab ... 116 “Record setting” tab ... 118 “Printer” tab ... 121 “Output format” tab ... 123 “PIP/NR” tab ... 125 “Release time H” tab ... 126 “Release time S” tab ... 127

4.4

System setup (connection setting) ... 128 “Peripheral (1)” tab ... 129 “Peripheral (2)” tab ... 133

4.5

Basic operation of the user settings ... 135 Displaying the user settings screen ... 135 Editing and newly registering user settings ... 137 Deleting the user settings ... 140 Saving the user settings to the portable memory ... 142 Loading the user settings from the portable memory ... 146

4.6

User settings (basic setup) ... 150 “Release 1” tab ... 151 “Release 2” tab ... 152 “PIP/POP” tab ... 153 “Enhancement” tab ... 155 “Color/Bright” tab ... 157 “Observation 1” tab ... 159 “Observation 2” tab ... 162

4.7

User settings (switch presets) ... 164 “Scope switch” tab ... 164 “Front panel” tab ... 165 “Keyboard” tab ... 166 “Foot switch” tab ... 167 Setting value of custom switch function ... 168

4.8

User settings (OSD customization) ... 171 “OSD” tab ... 171 “Custom disp 1” tab ... 174 “Custom disp 2” tab ... 175 CV-190 INSTRUCTION MANUAL

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“Custom disp 3” tab ... 176

4.9

User settings (UPD) ... 177 “Model” tab ... 177 “View” tab ... 179 “Screen” tab ... 181

4.10 User settings (Color tone) ... 182 4.11 Security settings for administrators ... 183 Basic operation of the security settings ... 183 “Account” tab ... 186 “User” tab ... 187 “Target menu” tab ... 189 “Admin” tab ... 191

4.12 Secure user registration ... 192 Displaying the user ID ... 192 Editing and newly registering user IDs ... 195 Deleting a user ID ... 197 Saving a user ID to the portable memory ... 198 Loading the user ID from the portable memory ... 199

4.13 Password ... 200

Chapter 5 Inspection ... 203 5.1

Precautions of workflow ... 203

5.2

Inspection workflow ... 204

5.3

Inspection of the power supply ... 205

5.4

Inspection of the examination light ... 206

5.5

Video monitor display inspection ... 206

5.6

Inspection of the automatic brightness adjustment function ... 207

5.7

Inspection of the monitor display ... 208

5.8

Inspection of the freeze function ... 209

5.9

Inspection of the release function ... 210

5.10 Inspection of the PIP/POP function ... 211 5.11 Inspection of the orientation function ... 211 5.12 Inspection of the custom switches ... 211 5.13 Inspection of the optical-digital observation function ... 211 Confirming the available observation mode ... 212 Inspection of NBI observation ... 214

5.14 Inspection of the endoscopic CO2 regulation unit (UCR) ... 215 5.15 Inspection of power off ... 216

Chapter 6 Operation ... 217 6.1

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Precautions for operation ... 217 CV-190 INSTRUCTION MANUAL

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6.2

Operation workflow ... 220

6.3

Connection of an endoscope ... 222 EVIS 190 series videoscope ... 223 EVIS Videoscope except for EVIS 190 series and ultrasound videoscope ... 224 VISERA series videoscope ... 225 Fiberscope and camera head or OES video converter ... 226 Rigid endoscope and camera head ... 228

6.4

Turning the video system center ON ... 229

6.5

White balance adjustment ... 230

6.6

Recall of user settings ... 233

6.7

Patient data ... 236 Entering patient data ... 237 Editing and deleting patient data ... 239

6.8

Observation and recording of the endoscopic image ... 240

6.9

Termination of the operation ... 240

Chapter 7 Function ... 243 7.1

Basic operation of the menu list ... 243

7.2

Logging in ... 245

7.3

Brightness adjustment ... 246 Iris mode ... 246 Brightness ... 247 Exposure ... 249 Iris area ... 251 Electronic shutter ... 252 Automatic gain control (AGC) ... 253

7.4

Image enhancement ... 254 Image enhancement ... 254 Contrast mode ... 255 Noise reduction ... 256

7.5

Color tone adjustment ... 257 Color tone level adjustment ... 257

7.6

Zooming the image ... 259 Electronic zoom function ... 259

7.7

Changing the endoscopic image screen ... 260 Freeze ... 260 Two screens display (PIP and POP displays) ... 261 Image size ... 266 Focus ... 267

7.8

Changing the displayed text information ... 268 Clearing characters from the screen ... 268 Cursor ... 270 Displaying the endoscope information window ... 270 Displaying the custom switch information window ... 272 CV-190 INSTRUCTION MANUAL

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Arrow pointer ... 273 Stopwatch ... 275 Displaying the hardware information ... 276

7.9

Changing the observation mode ... 277 Changing the observation mode (“WLI”, “NBI”) ... 277 Confirm the available optical-digital observation ... 277 NBI observation ... 278 NBI color mode ... 279

7.10 Recording the frozen image (releasing) ... 280 7.11 Recording and playing back the frozen image (portable memory or internal buffer) 281 Inserting the portable memory into the portable memory port ... 283 Removing the portable memory from the portable memory port ... 284 Formatting the portable memory ... 285 Checking the portable memory ... 286 Remaining capacity indicator of the memory ... 287 Recording the frozen image to the memory ... 288 Basic operation on thumbnail screen ... 289 Operation on the image screen (playback and printing) ... 293 Generating, printing, and storing the annotation images ... 296 Deleting the data including a folder ... 298 Transferring the unsent images ... 299 Image files and folders ... 301 Playing back the images using the personal computer ... 307

7.12 Remotely controlling the video recorder ... 309 7.13 Remotely controlling the video printer ... 312 Setting the number of sheets to be printed and the number of images on the print sheet 316 Printer lock ... 318

7.14 Recording on the image filing system ... 319 7.15 Remotely controlling the monitor ... 320 Image source of the monitor ... 320 FLIP function ... 321

7.16 Remotely controlling the UPD-3 ... 322 7.17 Presetting, calling, saving, and loading patient data ... 323 Displaying the “Select patient” screen ... 323 Newly registering and editing patient data ... 324 Deleting patient data ... 326 Calling patient data ... 328 Saving patient data to the portable memory ... 329 Loading patient data from the portable memory ... 332

7.18 Other functions ... 335 Assigning functions to the custom switches ... 335 Locking the keyboard ... 336 Reset ... 337 Displaying the color bar and the 50% white screen ... 338 Selecting the mode of character input from the keyboard ... 339

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Confirming and editing data of the endoscope ... 340 System reset ... 342

Chapter 8 Reprocessing, Storage, Disposal, and Transportation . 343 8.1

Reprocessing ... 343 Surface disinfectant cleaner ... 345

8.2

Signs of degradation from reprocessing and maximum number of reprocessing 346 Preparing equipment for reprocessing ... 347 Reprocessing the video system center and accessories ... 348

8.3

Storage ... 351

8.4

Disposal ... 352

8.5

Transportation ... 352

Chapter 9 Troubleshooting ... 353 9.1

Troubleshooting ... 353

9.2

Troubleshooting guide ... 353

9.3

Returning the video system center for repair ... 373

Appendix ... 375 Combination equipment ... 375 System chart ... 375

Specifications ... 378 Transportation, storage, and operation Environment ... 378 Specifications ... 379

Default settings list ... 384 System setup ... 384 User settings ... 386 Security settings for administrators ... 389

Security ... 390 Security level ... 390 Initial value of the password ... 390

EMC information ... 391 License information of Open Source Software ... 397 GNU GPL ... 397

End User License Agreement of Open Source Software modules ... 398 GNU GENERAL PUBLIC LICENSE Version 2 with Exception ... 398 GCC RUNTIME LIBRARY EXCEPTION Version 3.1, 31 March 2009 ... 399 Others ... 400 newlib ... 401 libgloss ... 413

Index ... 417 CV-190 INSTRUCTION MANUAL

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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.

 Rear panel Electric rating The product name, rated voltage, and frequency are shown. MEDICAL DEVICE EVIS EXERA III VIDEO SYSTEM CENTER MODEL OLYMPUS CV-190 POWER INPUT 220-240V 50/60Hz 150VA Indicates to see the instruction manual for the cable to be connected.

CE marking

Manufacturer

Crossed-out wheeled bin’ symbol

Potential equalization terminal

Serial number Authorized representative in the European Community Date of manufacture

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Labels and Symbols

 Front panel

Dry the video connector before insertion.

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).

 Back cover of this instruction manual Symbol

Description Manufacturer

Authorized representative in the European Community

Importer (into European Union)

Translation

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Important Information - Please Read Before Use

Important Information - Please Read Before Use

 Intended use/Intended purpose This video system center has been designed to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.

 Contraindications • Use only the devices listed in “ System chart” on page 375 for endoscopic observation or treatment of the heart or areas near the heart. Other combinations of equipment may cause ventricular fibrillation or seriously affect the cardiac function of the patient. • The use of medical devices not specifically designed for cardiac applications may cause ventricular fibrillation or seriously affect the cardiac function of the patient. As specified by the international standard IEC 60601-1, any applied part used for observation or treatment of the heart or areas near the heart must meet “TYPE CF applied part” requirements for low electrical leakage current. When using endoscopes for endoscopic cardiac applications, the applied part requirements include all devices directly connected to the endoscope, such as the light guide cable, camera head and telescope holder. Each of these devices must individually meet the “TYPE CF applied part” requirements for leakage current limits if they are to be used for cardiac applications.

 Clinical benefit Provides clear image of location, shape, and structure of the lesions leading to high rates of diagnostic yield.

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Important Information - Please Read Before Use

 Applicability of endoscopy and endoscopic treatment If there is an official standard on the applicability of endoscopy and endoscopic treatment that is defined by the healthcare facility's administration or other official institutions such as academic societies on endoscopy, follow that standard. Before starting endoscopy and endoscopic treatment, thoroughly evaluate its properties, purposes, effects, and possible risk (their natures, extent, and probability). Perform endoscopy and endoscopic treatment only when its potential benefits are greater than its risks. Fully explain to the patient the potential benefits and risks of the endoscopy and endoscopic treatment as well as any examination/treatment methods that can be performed in its place, and perform the endoscopy and endoscopic treatment only after obtaining the consent of the patient. Even after starting the endoscopy and endoscopic treatment, continue to evaluate the potential benefits and risks, and immediately stop the endoscopy/treatment and take proper measures if the risks to the patient become greater than the potential benefits.

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Important Information - Please Read Before Use

 Instruction manual This instruction manual contains essential information on using the video system center safely and effectively. Before use, thoroughly review this manual and the manuals of all equipment which will be used during the procedure and use the equipment as instructed. Keep this and all related instruction manuals in a safe, accessible location. If you have any questions or comments about any information in this manual, please contact Olympus.

 Terms used in this manual Light source: The light source provides light and electrical signals to the endoscope. It also provides electrical signals to the video system center.

Video converter: The video converter and video system convert a fiberscope image to a video signal which can be viewed on the monitor.

Camera head: The camera head is a device that converts endoscopic images from a fiberscope or rigid endoscope into monitor images.

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 the exclusive terminal for grounding.

Isolation transformer: The isolation transformer is a safety device that is used to isolate the noninsulated equipment with potentially high leakage currents to decrease the possibility of electric shock.

Automatic brightness adjustment: The automatic brightness adjustment automatically adjusts the intensity of the light emitted from the light source so that the endoscopic image will be maintained at constant brightness even if the distance between the distal end of the endoscope’s insertion tube and the subject changes.

Image sensor (CCD): The image sensor (CCD) is a device that converts light into electrical signals.

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Important Information - Please Read Before Use

Electronic shutter: The electronic shutter function changes the exposure time of the image sensor so that the brightness of an image is maintained on the video monitor.

Iris: The iris function is used to electrically measure the brightness of an endoscopic image to obtain a control signal for the purpose of automatic light adjustment.

Color adjustment: Color adjustment adjusts the color balance and the chroma on the monitor.

Freeze: The freeze function creates a stationary view of the moving image.

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

Edge enhancement: Edge enhancement is an image processing technique that electronically sharpens the edges of an image.

Structure enhancement: Structure enhancement is an image processing technique that electronically emphasizes the detailed patterns and edges of an image to increase sharpness.

AGC (automatic gain control): The AGC is used to increase the brightness of an endoscopic image electrically when the brightness of the image is dark because the distance between the endoscope’s distal end and the object is too long.

PIP (Picture in Picture): PIP function displays the image of the endoscopic live image and the image of an external device on the monitor simultaneously, where one image is embedded into the other image.

POP (Picture out Picture): POP function displays the image of the endoscopic live image and the image of an external device side by side on the monitor simultaneously.

Annotation A recorded frozen image is displayed with comments and a title. Up to 4 images can be displayed on the monitor at once.

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Important Information - Please Read Before Use

Portable memory: A digital medium for storage of images, etc.

Wash out: Wash out is the inability to see details in the endoscopic image due to excessive brightness.

SDTV: Standard Definition Television. It is the format used in standard video systems.

HDTV: High Definition Television. This is a format for high resolution video transmission featuring higher definition than the standard SDTV format.

Normal light observation (WLI = White Light Imaging): This is observation using white light.

Optical-digital observation: This is observation using filtered light.

NBI (Narrow Band Imaging) observation: This is optical-digital observation using narrowband light.

Custom switch: The custom switch is a general term for the buttons, keys, and switches to which functions can be assigned: “CUSTOM” button 1 and 2 on the front panel, “CUSTOM” key A, B, C, and D on the keyboard, remote switch 1, 2, 3, 4, and 5 on the endoscope and remote switch 1, 2, 3, and 4 on the foot switch.

Internal buffer: This is buffer space to store the frozen images, patient data, and user settings data.

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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 healthcare facility or person in charge of the department (department of internal medicine, etc.). The physician should be qualified to operate and perform safely 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 “ System chart” on page 375 to confirm that the video system 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.

 Repair and modification The video system 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 9, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 9, contact Olympus. This instrument is to be repaired by Olympus technicians only. Olympus is not liable for any injury or damage which 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 video system 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 electric shock. − When the video system center is used to examine a patient, do not allow metal parts of the 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 video system center immediately and contact Olympus. − Do not prepare, inspect or use the video system center with wet hands. • Never install and operate the video system 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. Otherwise, explosion or fire may result because the video system center is not explosion-proof.

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Important Information - Please Read Before Use

WARNING • In case of video system center failure or malfunction, always keep another video system center in the room ready for use. • Never insert anything into the ventilation grills of the video system center. It can cause an electric shock and/or fire. • Although the illumination light emitted from the endoscope’s distal end is required for endoscopic observation and treatment, it may also cause alteration of living tissues such as protein denaturation of liver tissue and biological tissue and perforation of the intestines by inappropriate use. Observe the following warnings on the illumination. − Always set the minimum required brightness. The brightness of the image on a video monitor may differ from the actual brightness at the distal end of an endoscope. Especially in combination with endoscopes using an electronic shutter function, pay attention to the brightness setting of the light source. When the video system center is used with a light source compatible with automatic brightness control function, be sure to use this function. The automatic brightness control function can keep the illumination light adjusted properly. Refer to the instruction manual for the light source for details. − Do not continue observation in proximity to tissue or keep the distal end of the endoscope in contact with living tissue for a long time. It may cause patient burns. − When discontinuing the use of the endoscope, be sure to turn the light source OFF. • This product may interfere with other medical electronic equipment used in combination with it. Before use, refer to the Appendix to confirm the compatibility of the video system center with all equipment to be used. • Do not use the video system center in any place where it may be subject to strong electromagnetic radiation (for example, in the vicinity of a microwave therapeutic equipment, MRI, wireless set, short-wave therapeutic equipment, cellular/portable phone, etc.). This may impair the performance of the video system center. • If the endoscopic image dims during use, blood, mucus or debris may have adhered to the light guide on the distal end of the endoscope. Carefully withdraw the endoscope from the patient and remove the blood or mucus to obtain optimum illumination and to ensure the safety of the examination. If you continue to use the endoscope in such a condition, the distal end temperature may rise and cause mucosal burns. It may also cause patient and/or operator injury. • Do not rely on the optical-digital observation method alone for primary detection of lesions or for a decision regarding any potential diagnostic or therapeutic intervention.

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Important Information - Please Read Before Use

WARNING • For reasons described below, do not rely on the NBI observation modality alone for primary detection of lesions or to make a decision regarding any potential diagnostic or therapeutic intervention. • To display endoscopic images, connect the output terminal of the video system center directly to the monitor. Do not make the connection via any ancillary equipment. Images may disappear during observation depending on the condition of the ancillary equipment. • The SDI signal is transmitted by daisy-chaining (chaining in a row) several devices. If one of the devices is turned OFF, the SDI signal is not transmitted to the rest of them. • Be sure that the video system center is not used adjacent to or stacked with other equipment (other than the components of the video system center or system) to avoid electromagnetic interference. • Electromagnetic interference may occur to the video system center 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 the video system center or shielding the location.

CAUTION • Do not use a pointed or hard object to press the buttons on the front panel and/or keyboard. This may damage the buttons. • Do not touch the electrical contacts inside the video system center’s connectors. • Do not apply excessive force to the video system center and/or other instruments connected. Otherwise, damage and/or malfunction can occur. • Do not connect or disconnect the endoscope, videoscope cable, video converter, or camera head while the video system center is turned ON. Connecting or disconnecting the endoscope while the video system center is ON may destroy the CCD. Turn the video system center OFF before connecting or disconnecting the endoscope.

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