OTV-S200 VISERA ELITE II VIDEO SYSTEM CENTER Instructions

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 ... 4 User qualifications ... 8 Instrument compatibility ... 8 Repair and modification ... 8 Signal words ... 9 Precautions ... 9 About Security ... 13

Summary of Equipment Functions ... 14

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 ... 26

2.3

Touch panel ... 28

2.4

Software keyboard ... 33

2.5

Rear panel ... 34

2.6

Side panels ... 35

2.7

Monitor ... 36

Front view ... 26

Home ... 28 Image view ... 30 Setting ... 32

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Contents

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

3.4

Connection to the AC mains power supply ... 44

3.5

Connection of the monitor ... 48

3.6

Connection of the keyboard ... 50

3.7

Connection of the video recorder ... 52

3.8

Connection of the video printer ... 56

3.9

Connection of the foot switch ... 57

Installation on the mobile workstation ... 42 Installation in another location ... 43 When the mobile workstation is used ... 45 When no mobile workstation is used ... 46 Compatible monitors ... 48 OEV262H ... 48 Compatible keyboards ... 50

Compatible video recorders ... 52 IMH-20 ... 52 IMH-10 ... 54 Compatible video printers ... 56 Compatible foot switch ... 57

Chapter 4 Function setup ... 59

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4.1

Setup list ... 59

4.2

Newly registering patient data ... 64

Patient data setup ... 59 System setup ... 59 User presets ... 61 Security settings ... 62 Maintenance ... 63

Displaying the patient data screen ... 64 Entering patient data ... 65 Editing the patient data ... 66 Deleting patient data ... 67 Loading the patient data ... 67

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Contents

4.3

Editing the system setup ... 68

Using the wizard ... 68 Displaying the language, date/time screen ... 70 Setting the language ... 71 Setting the date ... 73 Setting the time ... 74 Displaying the video output screen ... 76 Setting the output from the DVI OUT terminal ... 77 Setting the noise reduction ... 78 Displaying the monitor screen ... 81 Setting the date format ... 82 Enter comments on the monitor ... 83 Setting the brightness of the touch panel ... 85 Displaying the peripherals screen ... 88 Setting the connection of the REMOTE terminal ... 89 Setting the connection of the KEYBOARD terminal ... 90 Displaying the image record ... 92 Setting the ability of recording the endoscopic images ... 93 Setting the definition of the endoscopic images to be recorded ... 94 Setting the recording format of the endoscopic images ... 95 Setting the patient data to be saved along with the endoscopic image ... 98 Setting the auto deletion of the unsent endoscopic images ... 99 Setting the release time (HD) ... 101 Setting the release time (SD) ... 103 Setting the capture time ... 104 Displaying the link settings screen ... 106 Setting the examination start condition ... 107 Setting the examination end condition ... 108 Setting the lamp ignition timing ... 109 Setting the comments to be display on the monitor ... 111

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Contents

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4.4

Setting a user preset ... 113

4.5

Setting the security settings ... 189

Displaying the user presets screen ... 113 Register new user preset ... 114 Editing the user presets ... 116 Copy the user presets ... 118 Delete the user presets ... 119 Displaying the switch settings screen ... 121 Setting the custom switch ... 123 Displaying the operation settings screen ... 129 Setting the recording device to save the frozen image ... 131 Setting the pre-freeze scan area ... 133 Displaying the basic image adjustment screen ... 135 Setting the iris mode ... 136 Setting the contrast ... 139 Setting the iris area ... 141 Setting the iris sensitivity ... 143 Setting the image rotation ... 145 Displaying the WLI image adjustment screen ... 147 Setting the brightness mode ... 149 Setting the brightness ... 151 Setting the color tone and chroma ... 153 Setting the color mode ... 155 Setting the NBI cysto-color adjustment ... 157 Setting the AGC ... 158 Setting the AGC MAX gain ... 160 Setting the enhancement mode ... 162 Displaying the display preferences screen ... 165 Setting the endoscopic image size ... 166 Setting the data display on the monitor ... 168 Selecting the data displayed on the monitor ... 170 Setting the data displayed at start of exam ... 173 Setting the text size on the monitor ... 175 Setting the text color on the monitor ... 177 Setting the message and thumbnail layout on the monitor ... 179 Setting the data layout on the monitor ... 181 Setting the data layout on the right side of the monitor ... 183 Setting the aspect ratio ... 185 Setting the index image display time ... 187 Displaying the security settings screen ... 189 Setting the security function ... 190 Setting the security target ... 191 Registering an account ... 192 Editing an account ... 194 Deleting an account ... 195 Changing a password ... 196 Entering an ID and password ... 197

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4.6

Setting the maintenance ... 199

Displaying the maintenance screen ... 199 Displaying the export settings screen ... 200 Export all the settings ... 202 Export the user presets ... 203 Export the patient data ... 204 Export the system setup ... 205 Export the security settings (account) ... 205 Displaying the import settings screen ... 206 Import all the settings ... 208 Import the user presets ... 209 Import the patient data ... 210 Import the system setup ... 211 Import the security settings (Account) ... 211 Displaying the serial numbers ... 212 Displaying the message history ... 213 Displaying the user presets settings ... 216 Displaying the system setup settings ... 217 Displaying the security settings ... 218 Displaying the scope information ... 219 Displaying the test image on the monitor ... 220 Format the portable memory ... 221 Test the portable memory ... 222 Backup the settings and endoscopic images ... 223 Restore settings and endoscopic images ... 225 Format internal memory ... 226 Execute the system reset ... 227

Chapter 5 Inspection ... 229 5.1

Precautions of workflow ... 229

5.2

Inspection workflow ... 230

5.3

Connection of an endoscope ... 231

5.4

Inspection of the power supply ... 236

5.5

Inserting the portable memory (MAJ-1925) ... 237

5.6

Monitor display inspection ... 238

5.7

Inspection of the monitor display ... 239

5.8

Inspection of the examination light ... 240

5.9

Inspection of the brightness adjustment function ... 242

VISERA ELITE series videoscope ... 232 Fiberscope ... 233 Rigid endoscope and camera head ... 234

Inspection of the automatic brightness adjustment ... 243 Inspection of the manual brightness adjustment ... 244

5.10 Inspection of the freeze function ... 244 5.11 Inspection of the release function ... 245 OTV-S200 INSTRUCTION MANUAL

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5.12 Inspection of the endoscopic image rotation function ... 245 5.13 Inspection of the custom switches ... 245 5.14 After inspection ... 246

Chapter 6 Operation ... 247 6.1

Precautions for operation ... 247

6.2

Operation workflow ... 250

6.3

Turning ON the video system center and ancillary equipment ... 251

6.4

White balance adjustment ... 252

6.5

Load of user settings ... 252

6.6

Patient data ... 253

6.7

Observation and recording of the endoscopic image ... 255

6.8

Termination of the operation ... 256

Entering directly patient data with the touch panel ... 253 Entering directly patient data with the keyboard ... 254 Loading the patient data ... 254

Chapter 7 Home button functions ... 259

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7.1

Function list ... 259

7.2

Using the frequently used functions ... 261

7.3

Using the function for observation or recording ... 269

Loading the user preset ... 261 Igniting the examination lamp ... 263 Extinguishing the examination lamp ... 264 Adjusting the white balance ... 265 Setting the brightness ... 267

Displaying the observation and recording screen ... 269 Changing the observation mode ... 270 Freezing the endoscopic image ... 272 Recording the frozen image (Release) ... 273 Recording the live image with the video recorder ... 274 Recording the frozen image only with the video printer (Capture) ... 275 Changing the image enhancement ... 276 Changing the endoscopic image size ... 277 Changing the zoom ratio ... 278 Rotating the endoscopic image ... 280

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7.4

Using the color or brightness functions ... 281

7.5

Using function related to the display ... 295

7.6

Using the prepare functions ... 306

Displaying the color screen ... 281 Adjusting the brightness ... 282 Changing the iris mode ... 283 Changing the brightness mode ... 284 Adjusting the color tone ... 285 Changing the color mode ... 286 Changing the NBI cysto-color adjustment ... 288 Changing the contrast ... 289 Changing the iris area ... 290 Changing the iris sensitivity ... 291 Changing the laser mode ... 293 Changing the AGC ... 294 Displaying the information screen ... 296 Changing the data display ... 296 Entering a comment ... 297 Changing the text size ... 299 Changing the text color ... 300 Displaying the scope information ... 301 Displaying the switch information ... 302 Displaying the arrow pointer ... 304 Changing the Cursor ... 305 Displaying the preparation screen ... 306 Igniting the examination lamp ... 307 Extinguishing the examination lamp ... 308 Adjusting the white balance ... 309 Loading the user preset ... 310 Entering the patient data ... 312 Loading the patient data ... 314 Executing the exam end ... 315 Saving the user preset ... 316 Locking the touch panel ... 317 Resetting the current user preset ... 318

Chapter 8 Image view function ... 319 8.1

Deleting, exporting, and capturing the endoscopic images ... 319

8.2

Confirming the memory information ... 328

Displaying the image view screen ... 319 Deleting the folder with the endoscopic images ... 320 Deleting the endoscopic images ... 320 Printing the endoscopic images with the video printer ... 322 Exporting the folder with the endoscopic images to the portable memory ... 324 Exporting the endoscopic images to the portable memory ... 326 Image files and folders ... 329 Playing back the images using the personal computer ... 332

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Contents

Chapter 9 Reprocessing, Storage, Disposal, and Transportation ... 335 9.1

Reprocessing ... 335

9.2

Surface disinfectant cleaner ... 337

9.3

Signs of degradation from reprocessing and maximum number of reprocessing ... 338

9.4

Preparing equipment for reprocess ... 339

9.5

Storage ... 343

9.6

Disposal ... 344

9.7

Transportation ... 344

Equipment needed ... 339 Reprocessing video system center and accessories ... 340

Chapter 10 Troubleshooting ... 345 10.1 Troubleshooting ... 345 10.2 Troubleshooting guide ... 346 10.3 Returning the video system center for repair ... 361

Appendix ... 363 Combination equipment ... 363 System chart ... 363

Specifications ... 366 Transportation, storage, and operation Environment ... 366 Specifications ... 367

Default settings list ... 373 EMC information ... 377 License information of Open Source Software ... 383 GNU GPL ... 383 Wind River® VxWorks® ... 385 End User License Agreement of Open Source Software modules ... 385 Wind River® Diab Compiler ... 417 End User License Agreement of Open Source Software modules ... 417 Wind River® VxWorks® GNU C/C++ Compiler ... 428 End User License Agreement of Open Source Software modules ... 428 Others ... 431 newlib ... 431

Index ... 449

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OTV-S200 INSTRUCTION MANUAL

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 Blue

CE marking

Indicates to refer to the instruction manual for the cable to be connected. Refer to the instruction manual.

Manufacturer

Potential equalization terminal

Serial number

Date of Manufacture

OTV-S200 INSTRUCTION MANUAL

Authorized representative in the European Community Electric rating The product name, rated voltage, and frequency are shown. MEDICAL DEVICE VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S200 POWER INPUT: 100–240 V 50/60 Hz 400 VA

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Labels and Symbols

 Front panel

CAUTION Dry the video connector before insertion. ATTENTION Vaillez séchez le connecteur vidéo avant de l’insérer.

UDI label A label required by some countries’ regulations regarding identification of 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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OTV-S200 INSTRUCTION MANUAL

Important Information - Please Read Before Use

Important Information - Please Read Before Use

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

 Contraindications 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. Other combinations of equipment may cause ventricular fibrillation or seriously affect the cardiac function of the patient.

 Clinical benefit Provides a detailed view of anatomical structures which led to an improvement of safety and efficacy of the surgical procedure.

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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 risks (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.

 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 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 Camera head: The camera head is a device that converts endoscopic images taken by a fiberscope or rigid endoscope into electrical signals.

Scope information: Inherent information about the camera head or videoscope.

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

Video recorder: The video recorder is a device that records the video.

Hospital grade wall mains outlet: The hospital grade wall mains outlet is a wall AC mains power outlet socket having the exclusive terminal for grounding.

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OTV-S200 INSTRUCTION MANUAL

Important Information - Please Read Before Use

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 an 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.

Manual brightness adjustment: The manual brightness adjustment function is used to adjust manually the intensity of the light emitted from the light source.

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

Electric zoom: The electric zoom function changes the zoom ratio of the image.

Iris: The iris function is used to electrically measure the brightness of an endoscopic image.

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

Cysto-color adjustment: Cysto-color adjustment adjusts the color when observing the inside of the bladder.

Freeze: The freeze function makes a frozen image of a live image.

Prefreeze: The prefreeze function is used to display the image with the least blur when being frozen.

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

Capture: Stores the image in the ancillary equipment.

Index image: The index image is displayed on the monitor when executing the release function. OTV-S200 INSTRUCTION MANUAL

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Important Information - Please Read Before Use

Contrast: This is the ratio of brightness between the brightest and darkest areas in an image.

Edge enhancement: Edge enhancement is an image processing technique that electrically sharpens the edges of an image to increase sharpness.

Structure enhancement: Structure enhancement is an image processing technique that electrically 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.

Image rotation: The image rotation function is a function that rotates the endoscopic image by 180 degrees.

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

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

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.

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

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

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OTV-S200 INSTRUCTION MANUAL

Important Information - Please Read Before Use

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

Custom switch: The custom switch is a general term for the buttons, keys, and switches to which functions can be assigned: “CUSTOM” key on the keyboard, remote switch on the endoscope, remote switch on the foot switch, and custom button on the touch panel.

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Important Information - Please Read Before Use

 User qualifications This instrument should be used by persons trained in the use of this instrument. 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 society on endoscopy and endoscopy physicians, 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 safety perform 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 363 to confirm that the video system center is compatible with the ancillary equipment being used. Using incompatible equipment may result in patient injury or equipment damage and makes it impossible to obtain the expected functionality. This instrument complies with EMC standard for medical electrical equipment, edition 2 (IEC 60601-1-2: 2001), edition 3 (IEC 60601-1-2: 2007), and edition 4 (IEC 60601-1-2: 2014).

 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 may 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. 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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OTV-S200 INSTRUCTION MANUAL

Important Information - Please Read Before Use

 Signal words The following signal words are used throughout this manual:

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.

 Precautions Follow the warnings and cautions given below when handling the video system center. This information is to be supplemented by the warnings and cautions given in each chapter.

WARNING • Do not use this instrument for any purpose other than its “ Intended use/Intended purpose” on page 3. • Strictly observe the following precautions. Failure to do so may place the patient and medical personnel in danger of an 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.

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Important Information - Please Read Before Use

WARNING • 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, an explosion or a fire may result because the video system center is not explosion-proof. • In case of video system center failure or malfunction, always keep another video system center ready for use. • Never insert anything into the ventilation grills of the video system center. It can cause an electric shock and/or a fire. • Do not look directly into the distal end of the endoscope, the distal end of the light guide cable, or the output socket of the video system center when they are emitting light. The intense light may cause eye injury. • Do not touch the distal end of the light guide cable or the output socket of the light source immediately after disconnecting it from the video system center because they are extremely hot. Operator or patient injury can result. • 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 biological tissue 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. Be sure to use the automatic brightness control function. This function can keep the illumination light properly.  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.  When discontinuing the use of the endoscope, extinguish the examination lamp by tapping the lamp button. • This product may interfere with other medical electronic equipment used in combination with it. Before use, refer to “ System chart” on page 363 to confirm the compatibility of the video system center with all equipment to be used.

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OTV-S200 INSTRUCTION MANUAL

Important Information - Please Read Before Use

WARNING • 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. • When turning ON the video system center, never allow the distal end of an endoscope or a light guide cable to come in contact with the patient and/or other flammable materials, such as operating room drapes. Patient injury and/or a fire can result. • If the endoscopic image dims during use, blood, mucus, or debris may have adhered to the light guide cable 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. • Use only the power cord specified by Olympus. Otherwise, equipment malfunction and/or power cord burns may result. Also, never use it for other equipment contact Olympus. • 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. • Do not use the video system center when the live image cannot be observed. Otherwise, patient injury may occur. • 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. • 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.

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