OTV-S400 VISERA ELITE II VIDEO SYSTEM CENTER Instructions Jan 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 ... 3 Instruction manual ... 4 User qualifications ... 6 Instrument compatibility ... 6 Repair and modification ... 6 Classification of laser product ... 7 Signal words ... 7 Precautions ... 8 Security ... 11

Summary of Equipment Functions ... 12

Chapter 1 Checking the Package Contents ... 13 1.1

Checking the package contents ... 13

Chapter 2 Nomenclature and Functions ... 15 2.1

Symbols and descriptions ... 15

2.2

Front panel ... 19

2.3

Touch panel ... 20

2.4

Software keyboard ... 22

2.5

Rear panel ... 23

2.6

Front and rear side ... 24

2.7

Monitor ... 25 Endoscopic image screen ... 25

Chapter 3 Installation and Connection ... 27 3.1

Precautions for installation and connection ... 27

3.2

Installation workflow ... 28

3.3

Installation of the equipment ... 29 Installation of the mobile workstation (WM-NP2) ... 29 Installation in another location ... 31

3.4

Connection of the light source ... 32 Compatible light sources ... 32 CLV-S400 ... 33

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3.5

Connection of the monitor ... 34 Compatible monitors ... 34 LMD-X550S, LMD-X310S ... 35 OEV262H ... 37 OEV261H ... 38

3.6

Connection of the video recorder ... 39 Compatible video recorders ... 39 IMH-20 ... 39 IMH-10 ... 41

3.7

Connection to the AC mains power supply ... 43 When the mobile workstation (WM-NP2) is used ... 44 When a mobile workstation other than the WM-NP2 is used or when no mobile workstation is used ... 45

Chapter 4 Function Setup ... 47 4.1

Setup list ... 47

4.2

Editing the system setup ... 49 Displaying the date/language screen ... 49 Setting the language ... 50 Setting the date ... 53 Setting the time ... 55 Setting the date format ... 56 Displaying the video output screen ... 58 Setting the output from the SDI OUT terminal ... 59 Setting output the 3G/HD-SDI OUT terminal ... 61 Setting the color gamut ... 62 Displaying the touch panel setting screen ... 64 Setting the brightness of the touch panel ... 65

4.3

Editing the user presets ... 66 Selecting the user presets ... 66 Changing the name of the user ID ... 68 Setting the custom switch ... 70 Displaying the basic image adjustment ... 74 Setting the electronic shutter ... 76 Setting the electronic shutter speed ... 78 Setting the iris area ... 81 Setting the zoom ... 83 Setting the iris sensitivity ... 85 Displaying the WLI and NBI image adjustment ... 87 Adjusting the brightness ... 89 Adjusting the color tone ... 91 Setting the color mode ... 93 Adjusting the contrast ... 95 Setting the AGC MAX gain ... 98 Setting the enhancement ... 101 Setting the enhancement mode ... 103 Setting the data display ... 106

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Contents

4.4

Confirming the system ... 110 Displaying the maintenance screen ... 110 Displaying the scope information ... 111 Confirming the output image ... 113 Reset the current user preset ... 114 System reset ... 116 Service menu ... 116

Chapter 5 Inspection ... 117 5.1

Precautions of workflow ... 117

5.2

Inspection workflow ... 118

5.3

Connection of a camera head ... 119

5.4

Inspection of power ON ... 121

5.5

Inspection of the examination light ... 123

5.6

Monitor display inspection ... 123

5.7

Inspection of the monitor display ... 124

5.8

Inspection of the white balance adjustment ... 125

5.9

Inspection of the automatic brightness adjustment ... 125

5.10 Inspection of the one touch auto focus ... 125 5.11 Inspection of the release ... 125 5.12 Inspection of the custom switch ... 126 5.13 Inspection of the NBI observation ... 126 5.14 Inspection of power OFF ... 126

Chapter 6 Operation ... 127 6.1

Precautions for operation ... 127

6.2

Operation workflow ... 130

6.3

Turning ON the camera control unit ... 131

6.4

White balance adjustment ... 132

6.5

Recall of user preset ... 132

6.6

Observation and recording of the endoscopic image ... 132

6.7

Termination of the operation ... 133

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Contents

Chapter 7 Function ... 135 7.1

Function list ... 135

7.2

Using the frequently used functions ... 136 Changing the user preset ... 136 Ignite the examination lamp ... 140 Extinguish the lamp ... 143 Adjusting the white balance ... 146 Setting the brightness ... 151

7.3

Using the function for observation or recording ... 155 Displaying the observation and recording screen ... 155 Changing the observation mode ... 156 Recording the frozen image with the video recorder ... 159 Recording the live image with the video recorder ... 160 Changing the image enhancement ... 161 Changing the zoom ratio ... 163

7.4

Using the color or brightness functions ... 165 Displaying the color screen ... 165 Adjusting the brightness ... 166 Adjusting the color tone ... 166 Changing the color mode ... 167 Changing the contrast ... 169 Changing the electronic shutter ... 170 Changing the iris area ... 172 Changing the iris sensitivity ... 173

7.5

Using function related to the display ... 175 Displaying the information screen ... 175 Changing the information screen ... 176 Displaying the scope information ... 177

7.6

Using the prepare functions ... 178 Loading the user preset ... 178 Changing the lamp status ... 178 Adjusting the white balance ... 179 Displaying the preparation screen ... 179 Locking the touch panel ... 180 Saving the user preset ... 181

Chapter 8 Reprocessing, Storage, Disposal, and Transportation ... 183 8.1

Reprocessing ... 183

8.2

Surface disinfectant cleaner ... 185

8.3

Signs of degradation from reprocessing and maximum number of reprocessing ... 186

8.4

Preparing equipment for reprocess ... 187 Equipment needed ... 187 Reprocessing procedure ... 188

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Contents

8.5

Storage ... 191

8.6

Disposal ... 191

8.7

Transportation ... 192

Chapter 9 Troubleshooting ... 193 9.1

Troubleshooting ... 193

9.2

Troubleshooting guide ... 193

9.3

Returning the camera control unit for repair ... 202

Appendix ... 203 Combination equipment ... 203 System chart ... 203

Specifications ... 205 Transportation, storage, and operation Environment ... 205 Specifications ... 205

Default settings list ... 210 EMC information ... 212 License information of Open Source Software ... 218 GNU GPL/LGPL ... 218 End User License Agreement of Open Source Software modules ... 219 Others ... 239 glibc ... 239 e2fsprogs ... 245 util-linux ... 246 ncurses ... 247 portmap ... 248 zlib ... 250 Intel EDK ... 251 newlib ... 252

Index ... 267

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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 VISERA 4K UHD CAMERA CONTROL UNIT MODEL OLYMPUS OTV-S400 POWER INPUT 220-240V 50/60Hz 350VA

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

Potential equalization terminal

A

A

B

B

C

C

D

D

3G/HD-SDI OUT

1

2

1

2 SDI OUT

LIGHT SOURCE REC/ RELEASE RELEASE PAUSE 1 2

REMOTE

Serial number plate Authorized representative in the European Community

Crossed-out wheeled bin’ symbol Date of manufacture

Manufacturer

CE marking

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Labels and Symbols

 Front panel

Dry the video connector before insertion.

TYPE BF applied part

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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OTV-S400 INSTRUCTION MANUAL

Important Information - Please Read Before Use

Important Information - Please Read Before Use

 Intended use/Intended purpose The camera control unit has been designed to be used with Olympus endoscopes, camera heads, light source, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

 Contraindications As a TYPE BF applied part, this camera control unit must never be applied directly to the heart and must not be used in procedures involving cardiac observation or surgery. Leakage current from the TYPE BF applied part may be dangerous and cause ventricular fibrillation or seriously affect the cardiac function of the patient. Accordingly, always adhere to the following points: − Never apply the endoscope connected to this camera control unit to the heart or any area near the heart. − Never allow an EndoTherapy accessory or another endoscope applied to or near the heart to come in contact with an endoscope connected to this camera control unit.

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

 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 nature, 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 camera control unit safely and effectively. Before use, thoroughly review this manual and the manuals for 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 Light source: The light source provides light.

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

Scope information: Inherent information about the camera head.

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

Wall mains outlet: The wall mains outlet is a wall AC mains power outlet socket having an 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: The image sensor 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.

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.

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.

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

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

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

HD (high definition): This is a format for high-resolution video transmission.

4K: This is a format for high-resolution video transmission featuring higher definition than the HD format.

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

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Important Information - Please Read Before Use

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

Custom switch: Custom switch is a generic term for the buttons, keys, and switches to which functions can be assigned: the custom buttons 1, 2, 3, and 4 on the touch panel and remote switches 1, 2, and 3 on the camera head.

One touch auto focus: This is a function for adjusting the focus.

 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 203 to confirm that the camera control unit 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) and edition 3 (IEC 60601-1-2: 2007), edition 4 (IEC 60601-1-2: 2014).

 Repair and modification The camera control unit 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 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 that occurs because of repairs attempted by non-Olympus personnel.

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Important Information - Please Read Before Use

 Classification of laser product The camera control unit is CLASS 1 LASER PRODUCT in combination use with the camera head CH-S400-XZ-EB, CH-S400-XZ-EA.

Complies with FDA performance standards for laser products except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007.

 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.

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Important Information - Please Read Before Use

 Precautions Follow the warnings and cautions given below when handling the camera control unit. This information is to be supplemented by the warnings and cautions given in each chapter.

WARNING • Strictly observe the following precautions. Failure to do so may place the patient and medical personnel in danger of an electric shock. − When the camera control unit 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 the operation of the camera control unit immediately and contact Olympus. − Do not prepare, inspect, or use the camera control unit with wet hands. • Never install and operate the camera control unit 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 a fire may result because the camera control unit is not explosion-proof. • Be sure to prepare spare equipment to avoid interruption of the examination due to equipment failure or malfunction. • Never insert anything into the ventilation grills of the camera control unit. It can cause an electric shock and/or a fire.

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Important Information - Please Read Before Use

WARNING • 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 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 camera control unit 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. − Do not bring the distal end of the light guide cable or the distal end of the endoscope in contact with a flammable object, such as operating room drapes, while the examination lamp is ON. − When discontinuing the use of the endoscope, be sure to turn the light source OFF. • This product may interfere with other medical electric equipment used in combination with it. Before use, refer to the Appendix to confirm the compatibility of the camera control unit with all equipment to be used. • Do not use the camera control unit 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 camera control unit. • If the endoscopic image becomes dimmer during the procedure, blood or mucus may have adhered to the examination light outlet on the distal end of the endoscope. 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 with its obstructed examination light outlet, the temperature at the distal end may rise, which may cause patient injury or operator and/or patient burns. • To display endoscopic images, connect the output terminal of the camera control unit 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.

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Important Information - Please Read Before Use

WARNING • 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. • Before disconnecting the camera head from the endoscope, be sure to set the brightness control mode of the light source to manual mode or turn the examination lamp OFF. The light intensity can increase to the maximum and may cause burns or eye injury. • Use the camera control unit only under the conditions described in “ Transportation, storage, and operation Environment” on page 205 and “ Specifications” on page 205. Otherwise, improper performance, compromised safety, and/or equipment damage may result.

CAUTION • Use the power cord provided with this camera control unit. Using any other power cord may lead to malfunction of the camera control unit or burn the power cord. Note that this power cord is dedicated to this camera control unit and it must not be used for any other product. • Do not use a pointed or hard object to tap the button and touch panel on the front panel. This may damage the button and touch panel. • Do not touch the electrical contacts inside the camera control unit’s connectors. • Do not apply excessive force to the camera control unit and/or other instruments connected. Otherwise, damage and/or malfunction can occur. • Do not connect or disconnect the camera head while the camera control unit is turned ON. Connecting or disconnecting the camera head while the camera control unit is ON may destroy the image sensor. Turn the camera control unit OFF before connecting or disconnecting the camera head. • Be sure that the camera control unit is not used adjacent to or stacked with other equipment (other than the components of the camera control unit or system) to avoid electromagnetic interference. • Electromagnetic interference may occur on the camera control unit near equipment marked with the following symbol or other portable and mobile RF (Radio Frequency) communications equipment such as cellular phones. If electromagnetic interference occurs, mitigation measures may be necessary, such as reorienting or relocating this instrument, or shielding the location.

• Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.

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OTV-S400 INSTRUCTION MANUAL

Important Information - Please Read Before Use

NOTE In case any serious incident happens to User or Patient while operating the device, the incident should be reported to Olympus and the competent authority of the respective member state or country.

 Security Considering the possibility of data theft, corruption, and falsification, check that the portable memory is not infected with a computer virus and then make connections. Use the device constituting “OTV-S400” in an appropriate connection configuration as well as an operating environment. Use of “OTV-S400” in an inappropriate connection configuration as well as in an inappropriate use environment may lead to malfunction and/or data loss. Install the device following the installation instruction and installation environment recommended by the manufacturer of the device. Otherwise, it may cause damage or malfunction of the device. As for the storage management for the product, follow the facility’s security policy, considering the possibility of leakage of personal information by unauthorized access and data falsification by third parties.

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Summary of Equipment Functions

Summary of Equipment Functions Some of the functions of the camera control unit described below are enabled only when the required equipment is connected to the camera control unit. For more details, refer to the instruction manuals for the camera control unit and the other instruments connected.

 Displaying the endoscopic images on the monitor Either a high-definition (HDTV) monitor or 4K monitor can be used.

 NBI observations NBI observation is available. → Refer to “ Changing the observation mode” on page 156.

 Adjusting the endoscopic images The endoscopic images can be adjusted to enable clear and convenient observation. • Adjustment of the image color → Refer to “ Adjusting the color tone” on page 166. • Changing the brightness → Refer to “ Adjusting the brightness” on page 166. • Changing the contrast mode → Refer to “ Changing the contrast” on page 169. • Enhancement of edge lines and patterns of the images → Refer to “ Changing the image enhancement” on page 161. • Enlargement of the images → Refer to “ Changing the zoom ratio” on page 163.

 Recording images • The endoscopic image can be recorded or on the image recording device. → Refer to “ Recording the frozen image with the video recorder” on page 159. • The endoscopic video can be recorded or paused on the image recording device. → Refer to “ Recording the live image with the video recorder” on page 160.

 Customizing the operations The function settings for up to 10 users can be stored. → Refer to Section 4.3, “Editing the user presets”.

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1.1 Checking the package contents

Chapter 1

1.1

Checking the Package Contents

Checking the package contents Ch.1

Match all items in the package with the components shown below. Inspect each item for damage. If the camera control unit is damaged, a component is missing, or you have any questions, do not use the camera control unit; immediately contact Olympus.

 Camera control unit

VISERA 4K UHD camera control unit (OTV-S400)

 Accessories

Foot holder (4 pcs.)

Power cord

4K cable 3.0M (MAJ-2253)

Instruction manual

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