OTV-S200 VISERA ELITE II VIDEO SYSTEM CENTER Instructions April 2020

Contents

Contents Labels and Symbols ... 1 Important Information - Please Read Before Use ... 3 Intended use ... 3 Contraindications ... 3 Applicability of endoscopy and endoscopic treatment ... 3 Instruction manual ... 4 User qualifications ... 7 Instrument compatibility ... 7 Repair and modification ... 7 Signal words ... 8 Precautions ... 8 About Security ... 11

Summary of Equipment Functions ... 12

Chapter 1 Checking the Package Contents ... 15 1.1

Checking the package contents ... 15

Chapter 2 Nomenclature and Functions ... 17 2.1

Symbols and descriptions ... 17

2.2

Front panel ... 24 Front view ... 24

2.3

Touch panel ... 26 Home ... 26 Image view ... 28 Setting ... 30

2.4

Software keyboard ... 31

2.5

Rear panel ... 32

2.6

Side panels ... 33

2.7

Monitor ... 34

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Chapter 3 Installation and Connection ... 37 3.1

Precautions for installation and connection ... 37

3.2

Installation workflow ... 38

3.3

Installation of the equipment ... 39 Installation on the mobile workstation ... 40 Installation in another location ... 41

3.4

Connection to the AC mains power supply ... 42 When the mobile workstation is used ... 43 When no mobile workstation is used ... 44

3.5

Connection of the monitor ... 46 Compatible monitors ... 46 OEV262H ... 46

3.6

Connection of the keyboard ... 48 Compatible keyboards ... 48

3.7

Connection of the video recorder ... 50 Compatible video recorders ... 50 IMH-20 ... 50 IMH-10 ... 52

3.8

Connection of the video printer ... 54 Compatible video printers ... 54

3.9

Connection of the foot switch ... 55 Compatible foot switch ... 55

Chapter 4 Function setup ... 57 4.1

Setup list ... 57 Patient data setup ... 57 System setup ... 57 User presets ... 59 Security settings ... 60 Maintenance ... 61

4.2

Newly registering patient data ... 62 Displaying the patient data screen ... 62 Entering patient data ... 63 Editing the patient data ... 64 Deleting patient data ... 65 Loading the patient data ... 65

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4.3

Editing the system setup ... 66 Using the wizard ... 66 Displaying the language, date/time screen ... 68 Setting the language ... 69 Setting the data ... 71 Setting the time ... 72 Displaying the video output screen ... 74 Setting the output from the DVI OUT terminal ... 75 Setting the noise reduction ... 76 Displaying the monitor screen ... 79 Setting the date format ... 80 Enter comments on the monitor ... 81 Setting the brightness of the touch panel ... 83 Displaying the peripherals screen ... 86 Setting the connection of the REMOTE terminal ... 87 Setting the connection of the KEYBOARD terminal ... 88 Displaying the image record ... 90 Setting the ability of recording the endoscopic images ... 91 Setting the definition of the endoscopic images to be recorded ... 92 Setting the recording format of the endoscopic images ... 93 Setting the patient data to be saved along with the endoscopic image ... 96 Setting the auto deletion of the unsent endoscopic images ... 97 Setting the release time (HD) ... 99 Setting the release time (SD) ... 101 Setting the capture time ... 102 Displaying the link settings screen ... 104 Setting the examination start condition ... 105 Setting the examination end condition ... 106 Setting the lamp ignition timing ... 107 Setting the comments to be display on the monitor ... 109

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Contents

4.4

Setting a user preset ... 111 Displaying the user presets screen ... 111 Register new user preset ... 112 Editing the user presets ... 114 Copy the user presets ... 116 Delete the user presets ... 117 Displaying the switch settings screen ... 119 Setting the custom switch ... 121 Displaying the operation settings screen ... 127 Setting the recording device to save the frozen image ... 129 Setting the pre-freeze scan area ... 131 Displaying the basic image adjustment screen ... 133 Setting the iris mode ... 134 Setting the contrast ... 137 Setting the iris area ... 139 Setting the iris sensitivity ... 141 Setting the image rotation ... 143 Displaying the WLI image adjustment screen ... 145 Setting the brightness mode ... 147 Setting the brightness ... 149 Setting the color tone and chroma ... 151 Setting the color mode ... 153 Setting the NBI cysto-color adjustment ... 155 Setting the AGC ... 156 Setting the AGC MAX gain ... 158 Setting the enhancement mode ... 160 Displaying the display preferences screen ... 163 Setting the endoscopic image size ... 164 Setting the data display on the monitor ... 166 Selecting the data displayed on the monitor ... 168 Setting the data displayed at start of exam ... 171 Setting the text size on the monitor ... 173 Setting the text color on the monitor ... 175 Setting the message and thumbnail layout on the monitor ... 177 Setting the data layout on the monitor ... 179 Setting the data layout on the right side of the monitor ... 181 Setting the aspect ratio ... 183 Setting the index image display time ... 185

4.5

Setting the security settings ... 187 Displaying the security settings screen ... 187 Setting the security function ... 188 Setting the security target ... 189 Registering an account ... 190 Editing an account ... 192 Deleting an account ... 193 Changing a password ... 194 Entering an ID and password ... 195

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4.6

Setting the maintenance ... 197 Displaying the maintenance screen ... 197 Displaying the export settings screen ... 198 Export all the settings ... 200 Export the user presets ... 201 Export the patient data ... 202 Export the system setup ... 203 Export the security settings (account) ... 203 Displaying the import settings screen ... 204 Import all the settings ... 206 Import the user presets ... 207 Import the patient data ... 208 Import the system setup ... 209 Import the security settings (Account) ... 209 Displaying the serial numbers ... 210 Displaying the message history ... 211 Displaying the user presets settings ... 214 Displaying the system setup settings ... 215 Displaying the security settings ... 216 Displaying the scope information ... 217 Displaying the test image on the monitor ... 218 Format the portable memory ... 219 Test the portable memory ... 220 Backup the settings and endoscopic images ... 221 Restore settings and endoscopic images ... 223 Format internal memory ... 224 Execute the system reset ... 225

Chapter 5 Inspection ... 227 5.1

Precautions of workflow ... 227

5.2

Inspection workflow ... 228

5.3

Connection of an endoscope ... 229 VISERA ELITE series videoscope ... 230 Fiberscope ... 231 Rigid endoscope and camera head ... 232

5.4

Inspection of the power supply ... 234

5.5

Inserting the portable memory (MAJ-1925) ... 235

5.6

Monitor display inspection ... 236

5.7

Inspection of the monitor display ... 237

5.8

Inspection of the examination light ... 238

5.9

Inspection of the brightness adjustment function ... 240 Inspection of the automatic brightness adjustment ... 241 Inspection of the manual brightness adjustment ... 242

5.10 Inspection of the freeze function ... 242 5.11 Inspection of the release function ... 243 OTV-S200 INSTRUCTION MANUAL

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5.12 Inspection of the endoscopic image rotation function ... 243 5.13 Inspection of the custom switches ... 243 5.14 After inspection ... 244

Chapter 6 Operation ... 245 6.1

Precautions for operation ... 245

6.2

Operation workflow ... 248

6.3

Turning ON the video system center and ancillary equipment ... 249

6.4

White balance adjustment ... 250

6.5

Load of user settings ... 250

6.6

Patient data ... 251 Entering directly patient data with the touch panel ... 251 Entering directly patient data with the keyboard ... 252 Loading the patient data ... 252

6.7

Observation and recording of the endoscopic image ... 253

6.8

Termination of the operation ... 254

Chapter 7 Home button functions ... 257 7.1

Function list ... 257

7.2

Using the frequently used functions ... 259 Loading the user preset ... 259 Igniting the examination lamp ... 261 Extinguishing the examination lamp ... 262 Adjusting the white balance ... 263 Setting the brightness ... 265

7.3

Using the function for observation or recording ... 267 Displaying the observation and recording screen ... 267 Changing the observation mode ... 268 Freezing the endoscopic image ... 270 Recording the frozen image (Release) ... 271 Recording the live image with the video recorder ... 272 Recording the frozen image only with the video printer (Capture) ... 273 Changing the image enhancement ... 274 Changing the endoscopic image size ... 275 Changing the zoom ratio ... 276 Rotating the endoscopic image ... 278

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7.4

Using the color or brightness functions ... 279 Displaying the color screen ... 279 Adjusting the brightness ... 280 Changing the iris mode ... 281 Changing the brightness mode ... 282 Adjusting the color tone ... 283 Changing the color mode ... 284 Changing the NBI cysto-color adjustment ... 286 Changing the contrast ... 287 Changing the iris area ... 288 Changing the iris sensitivity ... 289 Changing the laser mode ... 291 Changing the AGC ... 292

7.5

Using function related to the display ... 293 Displaying the information screen ... 294 Changing the data display ... 294 Entering a comment ... 295 Changing the text size ... 297 Changing the text color ... 298 Displaying the scope information ... 299 Displaying the switch information ... 300 Displaying the arrow pointer ... 302 Changing the Cursor ... 303

7.6

Using the prepare functions ... 304 Displaying the preparation screen ... 304 Igniting the examination lamp ... 305 Extinguishing the examination lamp ... 306 Adjusting the white balance ... 307 Loading the user preset ... 308 Entering the patient data ... 310 Loading the patient data ... 312 Executing the exam end ... 313 Saving the user preset ... 314 Locking the touch panel ... 315 Resetting the current user preset ... 316

Chapter 8 Image view function ... 317 8.1

Deleting, exporting, and capturing the endoscopic images ... 317 Displaying the image view screen ... 317 Deleting the folder with the endoscopic images ... 318 Deleting the endoscopic images ... 318 Printing the endoscopic images with the video printer ... 320 Exporting the folder with the endoscopic images to the portable memory ... 322 Exporting the endoscopic images to the portable memory ... 324

8.2

Confirming the memory information ... 326 Image files and folders ... 327 Playing back the images using the personal computer ... 330

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Contents

Chapter 9 Care, Storage, and Disposal ... 333 9.1

Care ... 333

9.2

Storage ... 335

9.3

Disposal ... 336

Chapter 10 Troubleshooting ... 337 10.1 Troubleshooting ... 337 10.2 Troubleshooting guide ... 338 10.3 Returning the video system center for repair ... 353

Appendix ... 355 Combination equipment ... 355 System chart ... 355

Specifications ... 358 Environment ... 358 Specifications ... 359

Default settings list ... 364 EMC information ... 368 License information of Open Source Software ... 375 GNU GPL ... 375 Wind River® VxWorks® ... 377 End User License Agreement of Open Source Software modules ... 377 Wind River® Diab Compiler ... 409 End User License Agreement of Open Source Software modules ... 409 Wind River® VxWorks® GNU C/C++ Compiler ... 420 End User License Agreement of Open Source Software modules ... 420 Others ... 423 newlib ... 423

Index ... 441

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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

Blue

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

Manufacturer name Potential equalization terminal

Electric rating The product name, rated voltage, and frequency are shown.

Serial number

Date of manufacture

OTV-S200 INSTRUCTION MANUAL

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

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OTV-S200 INSTRUCTION MANUAL

Important Information - Please Read Before Use

Important Information - Please Read Before Use

 Intended use 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.

 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 hospital’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.

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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 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.

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.

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Important Information - Please Read Before Use

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.

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.

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Important Information - Please Read Before Use

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.

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 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 “ System chart” on page 355 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 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 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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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” 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 355 to confirm the compatibility of the video system center with all equipment to be used.

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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. • 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.

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Important Information - Please Read Before Use

CAUTION • Use the video system center only under the conditions described in “Environment” on page 358 and “Specifications” on page 359. Otherwise, improper performance, compromised safety, and/or equipment damage may result. • Do not allow a foreign object to penetrate the inside of the video connector socket, output socket, and portable memory port. The video system center may malfunction. • Do not use a pointed or hard object to press the buttons on the front panel, touch panel, and/or keyboard. This may damage the buttons. • Do not touch the electrical contacts inside the video system center’s connectors by hands. Equipment damage and/or malfunction may result. • 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 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 image sensor. Turn the video system center OFF before connecting or disconnecting the endoscope. • Do not leave the examination lamp ON when an endoscope is connected to the video system center. The examination light reaches the maximum intensity and the endoscope’s distal end becomes hot. In addition, smoke may also be produced if the debris attached to the distal end is heated. • Avoid using the video system center in a dusty environment. This may damage the video system center. • Confirm that there is no dust on the ventilation grills. Clean and vacuum dust from the ventilation grills using a vacuum cleaner, when necessary. Otherwise, the video system center may break down and get damaged from overheating.

 About Security Considering possibility of risk of leakage in personal information and tampering with data by a third party, manage and protect your account information by making unique password. Considering possibility that data may be stolen, destroyed, and/or falsified, ensure portable memory is not infected with a computer virus. Follow the facility security policy (ies) for storage and management of this product.

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