CV-1500 VIDEO SYSTEM CENTER Instructions July 2022

Contents

Contents Labels and Symbols ... 1 Important Information - Please Read Before Use ... 3 Intended use/Intended purpose ... 3 Contraindications ... 3 Clinical benefit ... 3 Applicability of endoscopy and endoscopic treatment ... 4 Instruction manual ... 5 User qualifications ... 10 Instrument compatibility ... 10 Repair and modification ... 10 Classification of safety of optical radiation ... 11 Classification of laser product ... 11 Signal words ... 11 Precautions ... 12 Precautions for illumination light emitted from the endoscope’s distal end ... 15 About Security ... 15

Summary of Equipment Functions ... 16

Chapter 1 Nomenclature and Functions ... 19 1.1

Symbols and descriptions ... 19

1.2

Front panel ... 30

1.3

Touch panel ... 32 Home ... 32 Image ... 34 Settings ... 35 Software keyboard ... 36

1.4

Rear panel ... 38

1.5

Side panels ... 40

1.6

Monitor ... 41

Chapter 2 Function setup ... 49 2.1

Display the screen of settings ... 49

Registering/Editing of patient information ... 51 2.2

Registering, editing, deleting, loading of patient information ... 51 Display the screen of setting patient data ... 52 Registering patient information ... 53 Editing patient information ... 54 Deleting patient information ... 55 Loading patient information ... 56

Setting user presets ... 57

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Security setting ... 58 Items of “Security settings” screen and reference information ... 58

2.3

Export the audit log ... 59

2.4

Updating and deleting the certificate ... 60 Updating the certificate ... 60 Delete the certificate ... 60

2.5

Initialize the password for the account with general user authority ... 61

2.6

Logging in/out of account ... 63 Logging in ... 63 Logout Manually ... 64

System setup ... 65 Set to connect the server ... 65 Operation and setting the maintenance function of this instrument ... 66 2.7

Operate the message history displayed by this instrument ... 66 Display the message history displayed by this instrument ... 66 Export the message history displayed by this instrument ... 68

2.8

Export/Import settings using portable memory ... 69 Initialize the portable memory ... 69 Confirming the availability of portable memory ... 70 Back up ... 71 Export settings ... 73 Restoring this instrument from the backup data ... 75 Import settings of the video system center ... 76 Import the all settings ... 78 Output the settings as a CSV file ... 78

2.9

Display and set the maintenance information and settings ... 79 Display the serial numbers ... 79 Edit the endoscope information ... 80 Setting the endoscope usage count to notify the inspection timing of endoscope ... 81 Display the color bar image on the monitor ... 83 Setting the notification of the inspection timing ... 83

2.10 Initialize this instrument ... 86 Initialize the internal memory ... 86 Reset all ... 87

Chapter 3 Inspection ... 89 3.1

Precautions of workflow ... 89

3.2

Inspection workflow ... 90

3.3

Connection of an endoscope ... 92

3.4

Inspection of the power supply ... 94

3.5

Inserting the portable memory ... 95 Compatible portable memory ... 95 Connecting a portable memory ... 95

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3.6

Monitor display inspection ... 96

3.7

Inspection of the monitor display ... 97

3.8

Inspection of the endoscopic image ... 98

3.9

Inspection of the brightness adjustment function ... 100

3.10 Inspection of the freeze function ... 101 3.11 Inspection of the release function ... 102 3.12 Inspection of the PIP/POP function ... 103 3.13 Inspection of the custom switches ... 104 3.14 Inspection of the optical-digital observation function ... 105 Checking the available observation mode ... 105 Inspection of optical-digital observation mode ... 105

3.15 Inspection of the air/water feeding function ... 106 3.16 Inspection of the server connection status ... 106 3.17 Turn OFF the power ... 107

Chapter 4 Operation ... 109 4.1

Precautions for operation ... 109

4.2

Operation workflow ... 112

4.3

Turning ON the video system center and peripheral device ... 113

4.4

Adjusting the white balance ... 114

4.5

Loading the user settings ... 116

4.6

Entering the patient information ... 117 Entering patient information with the touch panel ... 118 Entering patient information with the keyboard ... 118 Loading the patient information registered on this instrument ... 119 Loading patient information from the order search result ... 120

4.7

Observation and recording of endoscopic image ... 120

4.8

Termination of the operation ... 121

4.9

Disconnect the endoscope ... 122

4.10 Transportation ... 124

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Chapter 5 Home button functions ... 125 5.1

Displaying the home screen ... 125

5.2

The function of operating on Basic functions / custom functions screen ... 126 Loading the user settings ... 126 Searching the order ... 127 Loading the patient information ... 129 Entering the patient information ... 130 Turn the lamp ON/OFF ... 131 Adjusting the white balance ... 132 Executing the exam end ... 135 Disconnecting the endoscope ... 135 Using the custom function on basic function screen ... 137 Using the custom function on custom function screen ... 137

5.3

The function on the function list screen ... 138

5.4

Displaying the function list screen ... 143

5.5

Operating the observation image ... 144 Switching the observation mode ... 144 Switching the image enhancement mode ... 147 Switching the TXI ON/OFF ... 148 Switching the TXI mode ... 149 Switching the TXI level ... 150 Switching the MyCV Mode ON/OFF ... 151 Option Obser.1 ... 151 Freezing the endoscopic image ... 152 Switching the endoscopic image size ... 153 Electrically enlarging the endoscopic image ... 154 Switching the focus ... 155 Option control 1 – 5 ... 156

5.6

The functions of recording images ... 157 Recording the still image ... 157 Recording only a still image of an endoscopic image ... 158 Recording only a still image of an external image ... 159 Recording a still image by the color video printer ... 160 Recording a video with the video recorder ... 161 Setting the video recorder to record audio ... 163

5.7

The functions of adjusting the observation images ... 164 Adjusting the brightness ... 164 Switching the iris mode ... 165 Switching the contrast ... 166 Switching the BAI-MAC ON/OFF ... 167 Turning on the transillumination ... 168 Switching the electronic shutter ON/OFF ... 169 Switching the AGC ON/OFF ... 170 Switching the color tone ... 171 Switching the NBI color mode ... 173 Switching the RDI mode ... 174

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5.8

The function of changing the character information of the monitor ... 175 Switching the data display ... 175 Switching the text size ... 176 Entering a comment ... 177 Displaying the exam order information ... 179 Displaying the endoscope information in a pop-up window ... 180 Displaying the custom switch information in a pop-up window ... 181 Measuring time with stopwatch ... 182 Switching between displaying and hiding the cursor ... 183 Execute milestone release ... 184

5.9

The function of display format of PIP/POP screen ... 185 Switching between displaying and hiding the PIP sub screen ... 185 Switching between displaying and hiding the POP ... 187 Switching the PIP display mode ... 188 Changing the POP display mode ... 189 Switching the display size of the PIP sub screen ... 191 Switching the external video input terminal while displaying the PIP screen ... 192 Switching the external video input terminal during displaying POP screen ... 194

5.10 The function of operating peripheral equipment on remote ... 196 Selecting the type of gas to be supplied ... 196 Setting the gas supply ON/OFF ... 197 Setting the CO2 ON/OFF ... 198 Switching the gas supply pressure ... 199 Changing the CO2 supply pressure ... 199 Setting the water pump ON/OFF ... 200 Switching the water supply amount of the water pump ... 200 Switching the monitor input ... 201 Changing the color video printer settings ... 203 Switching the device that operates the color video printer ... 210 Changing the UPD-3 settings ... 211 Displaying ultrasound image on monitor ... 215 Freezing the ultrasound image ... 216 Controlling the ultrasound remotely ... 216

5.11 The functions used before examination ... 217 Turning the lamp ON/OFF (Preparation screen) ... 217 Adjusting the white balance (Preparation screen) ... 217 Adjusting the AFI color balance ... 218 Loading the user settings (Preparation screen) ... 224 Entering the patient information (Preparation screen) ... 225 Searching the order (Preparation screen) ... 225 Loading the patient information (Preparation screen) ... 226 Executing the start exam ... 227

5.12 The functions used at the end of inspection ... 228 Executing the exam end (End exam screen) ... 228 Disconnecting the endoscope (End exam screen) ... 228 Interrupting the endoscopic image transfer ... 229 Disabling the touch panel operation ... 229

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Chapter 6 Functions available on the image screen ... 231 6.1

Displaying the screen of image data ... 231

6.2

Operating the folders in which images are saved ... 232 Filtering the folders in which images are saved ... 232 Deleting the folder with the images ... 234 Transferring the folder with images to portable memory or server ... 236

6.3

Operating the images ... 238 Displaying the image ... 238 Deleting the images ... 239 Transferring images to portable memory or server ... 241 Printing the images ... 243

6.4

Displaying memory information ... 245

6.5

The structure of folders on portable memory and the detailed information of the image files and folders ... 246

6.6

Playing back the images using the PC ... 249

Chapter 7 Reprocessing, Storage, and Disposal ... 251 7.1

Reprocessing ... 251 Surface disinfectant cleaner ... 253 Signs of degradation from reprocessing ... 254 Preparing equipment for reprocessing ... 254 Reprocessing procedure ... 255

7.2

Storage ... 257

7.3

Disposal ... 258

Chapter 8 Troubleshooting ... 259

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8.1

Troubleshooting ... 259

8.2

Troubleshooting guide ... 260

8.3

Returning the video system center for repair ... 300

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Appendix ... 301 Combination equipment ... 301 System chart ... 301

Environment ... 304 Specifications ... 304 Security information of this instrument ... 314 Introduction ... 314 Usable peripheral devices ... 314 Product Security ... 314 Security Function for protection of security information ... 316 Security Function for external access protection ... 319 Audit log record and output function for inspection ... 320 Maintenance of security function ... 320

EMC information ... 321 Alarm information ... 327 Index ... 329

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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.

CE marking

EVIS X1 VIDEO SYSTEM CENTER MODEL OLYMPUS CV-1500 POWER INPUT: 100–240 V 50/60 Hz 600 VA

Manufacturer

Crossed-out wheeled bin’ symbol

Serial number

Equipotentiality

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

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Labels and Symbols

 Front panel Yellow Blue

Cautions that the emitted light from the distal end of the endoscope has hazard.

Indicates to refer to the instruction manual for action to avoid optical hazard.

TYPE BF applied part 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

Translation

Importer (into European Union)

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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 ancillary equipment for endoscopic diagnosis, treatment, and video observation. This product is designed to process electronic signals transmitted from Olympus video endoscopes, output images to monitors, provide illumination to the endoscope, supply air through the endoscope while inside the body and control/monitor ancillary equipment.

 Contraindications As a TYPE BF applied part, the endoscope connected to this video system center must never be applied directly to the heart. Leakage current from the TYPE BF applied part may be dangerous and cause ventricular fibrillation or otherwise seriously affect the cardiac function of the patient. Accordingly, always adhere to the following points. − Never apply the endoscope connected to this video system center 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 the endoscope connected to this video system center.

 Clinical benefit Depends on the connected endoscope.

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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 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 Server: The server is a device that receive information such as endoscopic images saved by this instrument and send a patient data and/or procedure information.

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

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

External video system center: This is the video system center CV-290/190/190 PLUS that is connected to this instrument when a 260/180 series endoscope is used in combination with this instrument.

Digital filing system: The digital filing system is a device that saves the frozen video image.

Endoscope position detecting unit: The endoscope position detecting unit is a device that observes the shape of the endoscope inserted inside the body.

Video system center: The video system center is a device that processes the signal from the endoscope and sends the endoscopic image to the monitor.

Flushing pump: The flushing pump is a device that delivers sterile water, degassed water or physiological saline.

Endoscopic CO2 regulation unit: The endoscopic CO2 regulation unit is a device that sends CO2 into the body.

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Important Information - Please Read Before Use

Powerspiral control unit: The powerspiral control unit is a device that supports insertion of the endoscope.

Endoscopic ultrasound center: The endoscopic ultrasound center is a device that performs endoscopic examination using ultrasound.

Healthcare facility grade wall mains outlet: The healthcare facility 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.

Network isolator: A safety device used to decrease the possibility of an electric shock when this instrument is connected to a network.

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.

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

Pre-freeze: The pre-freeze 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.

Index image: The index image is displayed on the monitor when executing the release function.

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

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

TXI (TeXture and color enhancement Imaging): TXI emphasizes tonal changes, patterns, and image outlines. It also corrects the brightness of dark areas.

BAI-MAC (Brightness Adjustment Imaging with Maintenance of Contrast): BAI-MAC maintains the brightness of the bright part of the endoscopic image and corrects the brightness of the dark part of the 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.

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

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

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

SDTV: This is a video signal with the same resolution as analog TV broadcasting.

HDTV: HDTV is a higher resolution video signal than SDTV.

4K: This video signal is a video signal that supports resolution two times that of HDTV and has a color gamut of BT.709.

Color gamut: The range of available colors.

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Important Information - Please Read Before Use

Data display: Information such as “date and time” and “patient data” displayed on the monitor.

Endoscope information: Information such as “model name” or “channel inner diameter” of the endoscope connected to this instrument.

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

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

Color mode: Color mode is a function that changes the color of the endoscope image.

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 blue and green narrow band light.

RDI (Red Dichromatic Imaging) observation: This is optical-digital observation using red dichromatic narrow band light and green illumination light.

AFI (Auto-Fluorescence Imaging) observation: This is optical-digital observation using blue excitation light and green illumination 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.

Software keyboard: The keyboard is displayed on the touch panel.

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Important Information - Please Read Before Use

Audit log: The log that records “when and by whom” operations are performed when security-related events occur.

MyCV Mode: MyCV Mode is a function that switches multiple functions at once.

Encryption key: Encryption key is a data that uses when restoring encrypted data.

Alarm system: It is a function to display alarm information.

Patient information: Following items are basic information of identification for patient. patient ID, name, sex. date of birth and ages.

Exam image: Image captured in endoscopy exam.

Exam information: Information generated for each examination. It includes patient information and exam image.

Account information: Account ID and password are managed in each authorities.

Setting information: They are set as User settings, system settings and security settings.

Backup information: They are transferred when backup function is operated. refer to “ Back up” on page 71.

Administrator authority: You can manage security function of CV-1500 and permit or restrict which functions can be used by olympus representative and general users.

General user authority: General user authority to access information of CV-1500 permitted by administrator authority.

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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 user qualification standard for performing endoscopy and endoscopic treatment that has been defined by the medical administration or other official bodies, such as professional associations for endoscopy or specialists in endoscopy, you should follow this standard. If there is no official qualification standard, the operator of this instrument must be approved by the medical safety manager of the healthcare facility or person in charge of the department (department of internal medicine, etc.). The physician should be qualified to operate and perform safely the planned endoscopy and endoscopic treatment following guidelines set by the academic societies on endoscopy, etc., and considering the difficulty of endoscopy and endoscopic treatment. This manual does not explain or discuss endoscopic procedures.

 Instrument compatibility Refer to “ System chart” on page 301 to confirm that the video system center is compatible with the peripheral device 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 can result. Some problems that appear to be malfunctions may be correctable by referring to Chapter 8, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 8, contact Olympus. This instrument is to be repaired by Olympus technicians only. Olympus is not liable for any injury or damage which occurs as a result of repairs attempted by non-Olympus personnel.

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Important Information - Please Read Before Use

 Classification of safety of optical radiation The video system center is Risk Group 2 (IEC 62471: 2006) product.

・UV emitted from this device. Skin irritation may result. Do not keep the distal end of the endoscope in contact with skin for a long time. ・The light emitted may be harmful to the eyes. Do not stare directly into the distal end of the endoscope while the examination light is ON.

 Classification of laser product The video system center is CLASS 1 LASER PRODUCT.

 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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