OTV-S190 VISERA ELITE VIDEO SYSTEM CENTER Instructions June 2014

Contents

Contents Labels and Symbols ... 1 Important Information - Please Read Before Use ... 3 Intended use ... 3 Applicability of endoscopy and endoscopic treatment ... 3 Instruction manual ... 3 User qualifications ... 7 Instrument compatibility ... 7 Repair and modification ... 7 Signal words ... 8 Dangers, warnings, and cautions ... 8 Cardiac applications ... 12

Summary of Equipment Functions ... 13 Displaying the endoscopic images on the monitor ... 13 Optical-digital observations ... 13 Adjusting the endoscopic images ... 13 Recording images ... 14 Entering patient data ... 14 Customizing the operations ... 14 Operation of ancillary equipment ... 14

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 ... 19

2.3

Rear panel ... 20

2.4

Keyboard (optional) ... 22

2.5

Side panels ... 28

2.6

Monitor ... 30 Endoscopic image display ... 30 Setting display (e.g.) ... 32

Chapter 3 Installation and Connection ... 33 3.1

Precautions of installation and connection ... 33

3.2

Installation work flow ... 34

3.3

Installation of the equipment ... 35 Installation on the mobile workstation (WM-NP2, WM-NP1, or WM-WP1) ... 36 Installation in another location ... 37

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3.4

Connection of the light source ... 38 Compatible light sources ... 38 CLV-S190, CLV-S40Pro, CLV-180 ... 39 CLV-S45 ... 40 CLV-S40 ... 41

3.5

Connection of the monitor ... 42 Compatible monitors ... 42 OEV261H ... 42 OEV191H ... 44 OEV181H ... 48 OEV191 ... 50

3.6

Connection of the keyboard ... 52

3.7

Connection of the video recorder (DVR) ... 53 Compatible video recorders ... 53 IMH-20 ... 54 IMH-10 ... 56 Other DVRs ... 58

3.8

Connection of the video printer ... 60 Compatible video printers ... 60

3.9

Connection of the foot switch ... 62

3.10 Connection to the AC mains power supply ... 63 When the mobile workstation (WM-NP2, WM-NP1, or WM-WP1) is used ... 64 When a mobile workstation other than the WM-NP2, WM-NP1, or WM-WP1 is used or when no mobile workstation is used ... 65

Chapter 4 Function setup ... 67 4.1

Setup list ... 67

4.2

Basic operation of the system setup ... 68 Displaying the system setup screen ... 68 Editing the system setup ... 71 Saving the system setup to the portable memory ... 73 Loading the system setup from the portable memory ... 74

4.3

System setup (system) ... 75 “Date/comment” tab ... 76 “Operation” tab ... 78 “Record setting” tab ... 79 “Printer” tab ... 80 “Output format” tab ... 80 “NR” tab ... 82 “Release time H” tab ... 82 “Release time S” tab ... 83

4.4

System setup (connection setting) ... 84 Connection setting ... 84

4.5

Basic operation of the user settings ... 86 Displaying the user settings screen ... 86

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Contents

Editing and new registering the user settings ... 88 Deleting the user settings ... 92 Saving the user settings to the portable memory ... 93 Loading the user settings from the portable memory ... 96

4.6

User settings (basic setup) ... 101 “Release 1” tab ... 102 “Release 2” tab ... 103 “PIP/POP” tab ... 104 “Enhancement” tab ... 106 “Color/Bright.” tab ... 108 “Observation 1” tab ... 110 “Observation 2” tab ... 112

4.7

User settings (switch presets) ... 113 “Scope switch” tab ... 113 “Front panel” tab ... 114 “Keyboard” tab ... 115 “Foot switch” tab ... 116 Setting value of custom switch function ... 117

4.8

User settings (OSD customization) ... 120 “OSD” tab ... 120 “Custom disp 1” tab ... 122 “Custom disp 2” tab ... 123 “Custom disp 3” tab ... 124

4.9

User settings (Color tone) ... 125

4.10 Security settings for administrators ... 126 Basic operation of the security settings ... 126 “Account” tab ... 130 “User” tab ... 131 “Target menu” tab ... 132 “Admin” tab ... 133

4.11 Secure user registration for administrators ... 134 Displaying the user ID ... 134 Editing and new registering the user ID ... 138 Deleting the user ID ... 140 Saving the user ID to the portable memory ... 141 Loading the user ID from the portable memory ... 142

4.12 Password ... 144

Chapter 5 Inspection ... 147 5.1

Precautions of inspection ... 147

5.2

Inspection work flow ... 148

5.3

Inspection of the power supply ... 149

5.4

Inspection of the examination light ... 150

5.5

Video monitor display inspection ... 150

5.6

Inspection of the automatic brightness adjustment function ... 151 OTV-S190 INSTRUCTION MANUAL

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Contents

5.7

Inspection of the monitor display ... 152

5.8

Inspection of the freeze function ... 153

5.9

Inspection of the release function ... 154

5.10 Inspection of the PIP/POP function ... 155 5.11 Inspection of the orientation function ... 155 5.12 Inspection of the remote switches ... 155 5.13 Inspection of the optical-digital observation function ... 155 Confirming the available observation mode ... 156 Inspection of NBI observation ... 157 Inspection of PDD observation ... 158

5.14 Inspection of power OFF ... 159

Chapter 6 Operation ... 161 6.1

Precautions of operation ... 161

6.2

Operation flow ... 163

6.3

Connection of an endoscope ... 165 VISERA series videoscope ... 166 Fiberscope and camera head ... 167 Rigidscope and camera head ... 168

6.4

Turning the video system center ON ... 170

6.5

White balance adjustment ... 171

6.6

Recall of user settings data ... 174

6.7

Patient data ... 177 Entering patient data ... 178 Editing and deleting patient data ... 180

6.8

Observation and recording of the endoscopic image ... 181

6.9

Termination of the operation ... 182

Chapter 7 Function ... 183 7.1

Basic operation of the menu list ... 183

7.2

Logging in ... 185

7.3

Brightness adjustment ... 186 Iris mode ... 186 Brightness ... 187 Exposure ... 189 Exposure area ... 191 Electronic shutter ... 192 Automatic gain control (AGC) ... 193

7.4

Image enhancement ... 194 Image enhancement ... 194 Contrast mode ... 195 Noise reduction ... 196

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Contents

7.5

Color tone adjustment ... 197 Color tone level adjustment ... 197

7.6

Zooming the image ... 199 Electronic zoom function ... 199

7.7

Changing the endoscopic image display ... 200 Freeze ... 200 Image size ... 201

7.8

Changing the displayed text information ... 202 Clearing characters from the screen ... 202 Cursor ... 204 Displaying the endoscope information window ... 205 Displaying the custom switch information window ... 206 Arrow pointer ... 207 Displaying the hardware information ... 210

7.9

Changing the observation mode ... 211 Changing the observation mode (“WLI”, “NBI”, “PDD”) ... 211 Confirm the available optical-digital observation ... 212 NBI observation ... 212 NBI color mode ... 214 PDD (Photo Dynamic Diagnosis) observation ... 215

7.10 Recording the frozen image (releasing) ... 218 7.11 Recording and playing back the frozen image (portable memory or internal buffer) ... 219 Inserting the portable memory into the portable memory port ... 221 Removing the portable memory from the portable memory port ... 222 Formatting the portable memory ... 223 Checking the portable memory ... 224 Remaining capacity indicator of the portable memory ... 225 Recording the frozen image to the memory ... 226 Basic operation on thumbnail screen ... 227 Operation on the image screen ... 231 Generating and storing the annotation images ... 233 Deleting the data including a folder ... 235 Transferring the internal buffer folder ... 236 Image files and folders ... 238 Playback the images using the personal computer ... 240

7.12 Remotely controlling the DVR ... 242 7.13 Remotely controlling the video printer ... 245 7.14 Remotely controlling the monitor ... 248 Two screens display (PIP and POP displays) ... 248 Image source of the monitor ... 251 FLIP function ... 252

7.15 Presetting, calling, saving, and loading patient data ... 253 Displaying the “Select patient” screen ... 253 New registering and editing patient data ... 254 Deleting patient data ... 256 OTV-S190 INSTRUCTION MANUAL

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Calling patient data ... 258 Saving patient data to the portable memory ... 259 Loading patient data from portable memory ... 262

7.16 Other functions ... 265 Assigning functions to the custom switches ... 265 Locking the keyboard ... 266 Reset ... 267 Displaying the color bar and the 50% white screen ... 268 Selecting the mode of character input from the keyboard ... 269 Confirming and editing data of the endoscope ... 270 System reset ... 272

7.17 Operation without the keyboard ... 273 Operation by the “Function Operation Panel” menu ... 273 Character input by the software keyboard ... 275

Chapter 8 Care, Storage, and Disposal ... 277 8.1

Care ... 277

8.2

Storage ... 278

8.3

Disposal ... 278

Chapter 9 Troubleshooting ... 279 9.1

Troubleshooting ... 279

9.2

Troubleshooting guide ... 280

9.3

Returning the video system center for repair ... 292

Appendix ... 293 Combination equipment ... 293 System chart ... 293

Specifications ... 296 Environment ... 296 Specifications ... 297

Default settings list ... 302 System setup ... 302 User settings ... 303 Security settings for administrators ... 305

Multilingual typing by the keyboard ... 306 Security ... 308 Security level ... 308

EMC information ... 309 Index ... 315

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OTV-S190 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 Electric rating The product name, rated voltage, and frequency are shown. VISERA ELITE VIDEO SYSTEM CENTER MODEL OLYMPUS OTV-S190 POEWER INPUT 220 – 240 V 50/60 Hz 150 VA

CE marking

Crossed-out wheeled bin’ symbol Indicates to see the instruction manual for the cable to be connected.

Manufacturer name Serial number plate Potential equalization terminal

OTV-S190 INSTRUCTION MANUAL

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Labels and Symbols

 Front panel

Dry the video connector before insertion.

 Back cover of this instruction manual Symbol

Description Manufacturer

Authorized representative in the European Community

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OTV-S190 INSTRUCTION MANUAL

Important Information - Please Read Before Use

Important Information - Please Read Before Use

 Intended use 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. Do not use this video system center for any purpose other than its intended 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 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 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.

 Instruction manual This instruction manual contains essential information on using this 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, please contact Olympus.

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Important Information - Please Read Before Use

 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.

Camera head: The camera head is a device that converts endoscopic images from a fiberscope or rigidscope 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 non insulated 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): Image sensor (CCD) is a device that converts light into electrical signals.

Electronic shutter: Electronic shutter is a device that 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 on the monitor.

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OTV-S190 INSTRUCTION MANUAL

Important Information - Please Read Before Use

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 both the image of the endoscopic live image and the image of an external device on the monitor simultaneously.

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

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 analog video systems.

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

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Important Information - Please Read Before Use

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 the narrow band light.

PDD (Photo Dynamic Diagnoses) observation: This is optical-digital observation using exciting light. This function may not be available in some areas.

Custom switch The custom switch is a general term for the buttons, keys, and switches that 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, and 4 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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OTV-S190 INSTRUCTION MANUAL

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 293 to confirm that this 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 3 (IEC 60601-1-2: 2007), edition 2 (IEC 60601-1-2: 2001). However, when connected to an instrument that complies with the EMC standard for medical electrical equipment, edition 1 (IEC 60601-1-2: 1993), the whole system complies with edition 1.

 Repair and modification This 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 video system center is to be repaired by Olympus technicians only.

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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 this 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 this 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 video system center, stop operation of the video system center immediately and contact Olympus.  Do not prepare, inspect or use this video system center with wet hands. • Never install and operate the video system center in the following locations. An explosion or fire may result because this video system center is not explosion-proof.  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.  Flammable liquids are near.

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OTV-S190 INSTRUCTION MANUAL

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. • 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 perforation of the intestines through 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 level setting of the light source. When this 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 properly. Refer to the instruction manual for the light source for details.  Do not continue observation in the 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 video system center may interfere with other medical electronic equipment used in combination with it. Before use, refer to the “Appendix” to confirm the compatibility of this video system center with all equipment to be used. • Do not use this video system center in locations exposed 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 adhere to the light guide on the distal end of the endoscope. Carefully withdraw the endoscope from the patient and remove the blood or mucus in order 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.

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 this 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 this video system center is turned ON. Connecting or disconnecting the endoscope while this video system center is ON may damage the CCD. Turn the video system center OFF before connecting or disconnecting the endoscope. • Clean and vacuum dust the ventilation grills using a vacuum cleaner, when necessary. Otherwise, the video system center may break down and gets damaged from overheating. • Be sure that this video system center is not used adjacent to or stacked with other equipment (other than the components of this video system center or system) to avoid electromagnetic interference. • Electromagnetic interference may occur to this video system center when it is placed near equipment marked with the following symbol or other portable and mobile RF (Radio Frequency) communications equipment such as cellular phones. If radio interference occurs, mitigation measures may be necessary, such as reorienting or relocating this video system center or shielding the location.

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OTV-S190 INSTRUCTION MANUAL

Important Information - Please Read Before Use

NOTE As defined by the international safety standard (IEC 60601-1), medical electrical equipment is classified into the following types: TYPE CF applied part (the instrument can safely be applied to any part of the body, including the heart), and TYPE B/BF applied part (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 which 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

TYPE B applied part

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Important Information - Please Read Before Use

 Cardiac applications DANGER • Use only the devices listed in “ System chart” on page 293 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. • For cardiac applications, never support the endoscope with a metal surgical arm that is not electrically isolated from the ground. If not isolated, the endoscope will be connected to the ground through the surgical arm and bed, and will conduct unexpected leakage current that may 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.

NOTE • The light guide cables and camera heads listed in “ System chart” on page 293 (TYPE CF applied part) that are suitable for cardiac applications bear a mark. • The surgical holder for telescope (SH-1) has an electrically isolated arm structure that isolates the endoscope from the ground. This design makes the SH-1 suitable for cardiac applications.

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OTV-S190 INSTRUCTION MANUAL

Summary of Equipment Functions

Summary of Equipment Functions This video system center is a system controller of the endoscopic image observation system that displays, records, and prints endoscopic images. Some of the functions of this video system center described below are enabled only when the required equipment are connected to this video system center. For more details, refer to the instruction manuals for this video system center and the required ancillary equipment.

 Displaying the endoscopic images on the monitor • The endoscopic live image and the other images of the equipment connected to this video system center can be displayed on the monitor. • Either a standard-definition (SDTV) monitor or high-definition (HDTV) monitor can be used.

 Optical-digital observations NBI observation or PDD*1 observation is available.  See Section 7.9, “Changing the observation mode” on page 211 *1 PDD observation may not be available in some areas.

 Adjusting the endoscopic images Images can be adjusted to enable clear and convenient observation. • Adjustment of the image color  See “ Color tone level adjustment” on page 197. • Changing the brightness  See “ Brightness” on page 187. • Changing the iris mode  See “ Iris mode” on page 186. • Changing the contrast mode  See “ Contrast mode” on page 195. • Enhancement of edge lines and patterns of the images  See “ Image enhancement” on page 194. • Changing the image size  See “ Image size” on page 201. • Enlargement of the images  See “ Electronic zoom function” on page 199. OTV-S190 INSTRUCTION MANUAL

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