OIP-1 Endoscopy CAD System Instructions

Contents

Contents Labels and Symbols ... 1 Important Information - Please Read Before Use ... 3 Intended use/Intended purpose ... 3 Contraindications ... 3 Clinical benefit ... 3 Applicability of endoscopy and endoscopic treatment ... 3 Instruction manual ... 4 User qualifications ... 6 Instrument compatibility ... 6 Repair and modification ... 6 Signal words ... 7 Precautions ... 7

Chapter 1 Checking the Package Contents ... 11 1.1

Checking the package contents ... 11

Chapter 2 Nomenclature and Functions ... 13 2.1

Front panel ... 13

2.2

Rear panel ... 14

2.3

Side panels ... 15

2.4

Monitor ... 16

Chapter 3 Installation and Connection ... 17 3.1

Precautions for installation and connection ... 17

3.2

Installation workflow ... 18

3.3

Installation of the equipment ... 19 Installation of the equipment ... 20

3.4

Connection to the AC mains power supply ... 22 When the mobile workstation (WM-NP3) is used ... 23 When no mobile workstation is used ... 24

3.5

Connection of the video system center ... 24 Compatible video system center ... 24 CV-1500 ... 25

3.6

Connection of the monitor ... 26 Compatible monitors ... 26 OEV321UH ... 26 OEV262H ... 28 OEV261H ... 30

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Contents

3.7

Connection of the video recorder ... 32 Compatible video recorders ... 32 IMH-200 ... 33 IMH-20 ... 34 IMH-10 ... 35

Chapter 4 Function setup ... 37 4.1

Setup list ... 37

4.2

Basic operation of the user settings ... 38 Loading the user settings using the the video system center ... 38 Loading the user settings directly from the Endoscopy CAD system ... 40 Editing user settings ... 41 Initializing the user settings ... 44

4.3

User settings (Sub-image display) ... 45

4.4

User settings (Marker/flag) ... 46

4.5

User settings (Auto ON/OFF) ... 48

4.6

Basic operation of the system setup ... 49 Displaying the system setup ... 49 Editing the system setup ... 50 Initializing the system setup ... 51

4.7

System setup ... 52

4.8

Setting custom switches ... 54

Chapter 5 Inspection ... 55 5.1

Precautions of workflow ... 55

5.2

Inspection workflow ... 56

5.3

Inspection of the power supply ... 57

5.4

Monitor display inspection ... 57

5.5

Inspection of the CAD ... 58

5.6

Inspection of power off ... 60

Chapter 6 Operation ... 61 6.1

Precautions for operation ... 61

6.2

Operation workflow ... 62

6.3

Turning ON the Endoscopy CAD system and ancillary equipment ... 63

6.4

Loading the user settings ... 63

6.5

Display methods of the CAD ... 64 Displaying the detection result in normal mode ... 64 Displaying the detection result in target mode ... 65

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Contents

6.6

Starting the endoscopic examination ... 66 Operation of the CAD in normal mode ... 66 Operation of the CAD in target mode ... 67 Switching the sub-image display in normal mode ... 67 CAD operation chart ... 68 Change settings of the sub image ... 70 Non-display of the CAD detection result ... 71

6.7

Termination of the operation ... 72

6.8

Transportation ... 72

Chapter 7 Function ... 73 7.1

Operation of the setting menu ... 73

7.2

Displaying the OIP-1 information ... 75 OIP-1 information ... 75

7.3

Confirming the message history ... 78 Message history ... 78

7.4

Export/import the setting data ... 82 Inserting the portable memory ... 82 Removing the portable memory ... 83 Export settings ... 83 Import settings ... 85

Chapter 8 Reprocessing, Storage, and Disposal ... 87 8.1

Reprocessing ... 87 Surface disinfectant cleaner ... 88 Signs of degradation from reprocessing ... 89 Preparing equipment for reprocessing ... 89 Reprocessing procedure ... 90

8.2

Storage ... 93

8.3

Disposal ... 93

Chapter 9 Troubleshooting ... 95 9.1

Troubleshooting ... 95

9.2

Troubleshooting guide ... 96

9.3

Returning the Endoscopy CAD system for repair ... 103

Appendix ... 105 Combination equipment ... 105 System chart ... 105

Specifications ... 107 Environment ... 107 Specifications ... 108

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Contents

Default values table ... 110 User setting ... 110 System setup ... 110

EMC information ... 111 Open Source Software license information of this instrument ... 117

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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. ENDOSCOPY CAD SYSTEM OIP-1 POWER INPUT 100 – 240 V

50/60 Hz 275 VA

Medical Device CE marking Potential equalization terminal

Date of Manufacture

Serial number

Manufacturer name

Authorized representative in the European Community Crossed-out wheeled bin’ symbol

OIP-1 INSTRUCTION MANUAL

Fuses information

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

1

Labels and Symbols

 Front panel

UDI label A label required by some countries’ regulations regarding identification of medical devices 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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OIP-1 INSTRUCTION MANUAL

Important Information - Please Read Before Use

Important Information - Please Read Before Use

 Intended use/Intended purpose The Endoscopy CAD system processes the electronic signals received from the endoscopy video system center and overlays additional information on the observation monitor. The device directs the user’s attention to areas of interest for further clinical assessment. The device is intended to assist physicians in the detection of mucosal abnormalities such as potential colorectal polyps during colonoscopy. The device is an adjunctive tool, and the user should not rely solely on the device for detection of abnormalities.

 Contraindications None known.

 Clinical benefit Depends on the connected endoscope.

 Applicability of endoscopy and endoscopic treatment If there is an official standard on the applicability of endoscopy and endoscopic treatment that is defined by the healthcare facility’s administration or other official institutions such as academic societies on endoscopy, follow that standard. Before starting endoscopy and endoscopic treatment, thoroughly evaluate its properties, purposes, effects, and possible risks (their natures, extent, and probability). Perform endoscopy and endoscopic treatment only when its potential benefits are greater than its risks. Fully explain to the patient the potential benefits and risks of the endoscopy and endoscopic treatment as well as any examination/treatment methods that can be performed in its place, and perform the endoscopy and endoscopic treatment only after obtaining the consent of the patient. Even after starting the endoscopy and endoscopic treatment, continue to evaluate the potential benefits and risks, and immediately stop the endoscopy/treatment and take proper measures if the risks to the patient become greater than the potential benefits.

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Important Information - Please Read Before Use

 Instruction manual This instruction manual contains essential information on using the Endoscopy CAD system 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 Video recorder: The video recorder is a device that records the video.

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.

Healthcare facility grade wall mains outlet: The healthcare facility wall mains outlet is a wall AC mains power outlet socket having the exclusive terminal for grounding.

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

Internal memory This is a space to store the setting data etc. It also includes an area to set additional program data.

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

CAD The CAD is Computer Aided Diagnosis/Detection generally. In this equipment, this function displays supplementary information on the monitor which indicates the existence and locations of potential colorectal polyps.

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.

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Important Information - Please Read Before Use

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.

Optical-digital observation This is observation using specific filtered light

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

RDI (Red Dichromatic Imaging) observation This is optical-digital observation using red narrow band light.

AFI (Auto-Fluorescence Imaging) observation This is optical-digital observation using blue light.

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

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 four times that of HDTV and has a color gamut of BT.709.

Color gamut The range of available colors.

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.

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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 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 105 to confirm that the Endoscopy CAD system 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 Endoscopy CAD system 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 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

 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.

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

WARNING • Never install and operate the Endoscopy CAD system 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. • Strictly observe the following precautions. Failure to do so may place the patient and medical personnel in danger of an electric shock. − Keep fluids away from all electrical equipment. If fluids are spilled on or into the unit, stop operation of the Endoscopy CAD system immediately and contact Olympus. − Do not prepare, inspect, or use the Endoscopy CAD system with wet hands.

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Important Information - Please Read Before Use

WARNING • Do not use this instrument for any purpose other than its “ Intended use/Intended purpose” on page 3. • Be aware that the recognition processing of this instrument may not detect a lesion and may falsely detect normal tissue as abnormal. Considering this point, use the detection function just as a reference. • Do not use the Endoscopy CAD system 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. • Use the Endoscopy CAD system only under the conditions described in “ Environment” on page 107. Otherwise, improper performance, compromised safety, and/or equipment damage may result. • Be sure that this instrument is not used adjacent to or stacked with other equipment (other than the components of this instrument or system) to avoid electromagnetic interference. Electromagnetic interference may cause malfunction or failure. • Electromagnetic interference may occur on this instrument 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.

• The Endoscopy CAD system 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.

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Important Information - Please Read Before Use

CAUTION • Never insert anything into the ventilation grilles of the Endoscopy CAD system. It can cause an electric shock and/or a fire. • 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 allow a foreign object to penetrate the inside of the AC power inlet, portable memory port and other terminals described in Chapter 2, “Nomenclature and Functions”. The Endoscopy CAD system may malfunction. • Avoid using the Endoscopy CAD system in a dusty environment. This may damage the Endoscopy CAD system. • Do not apply excessive force to the Endoscopy CAD system and/or other instruments connected. Otherwise, damage and/or malfunction can occur.

NOTE • 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 Endoscopy CAD system may break down and get damaged from overheating. • Do not use a pointed or hard object to press the buttons on the front panel. This may damage the buttons.

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Important Information - Please Read Before Use

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OIP-1 INSTRUCTION MANUAL

1.1 Checking the package contents

Chapter 1

1.1

Checking the Package Contents Ch.1

Checking the package contents

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

 Endoscopy CAD system

Endoscopy CAD system (OIP-1)

 Accessories

12G-SDI cable 1.5 M (MAJ-2426)

Communication cable 1.8 M (MAJ-1948)

Foot holder (MAJ-1433, 4 pcs. with a pattern)

Instruction manual

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1.1 Checking the package contents

Ch.1

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2.1 Front panel

Chapter 2

2.1

Nomenclature and Functions

Front panel Ch.2 1

2

3

4

5

6

7

8

9

12

No.

Nomenclature

10

11

Description

1

Power switch

Press to turn the Endoscopy CAD system ON or OFF.

2

Power indicator

Lights up when the Endoscopy CAD system is ON.

3

CAD indicator

Lights up when the CAD is ON.

4

CAD button

Switches the CAD between ON and OFF.

5

MODE button 1

Switches the CAD between ON and OFF and selects the display method of the CAD.

6

MODE button 2

Turns the sub-image display on and off and selects the display position when the CAD is ON. The message box position is same as the sub-image position.

7

BACK button

Returns to the previous screen.

8

Arrow button

Selects the item when the menu is displayed.

9

ENTER button

Determines the selected item.

10

MENU button

Turns the home menu display on and off.

11

Portable memory port

Insert the portable memory in this port to record data or to update the program inside of the Endoscopy CAD system.

12

Portable memory access indicator

Lights up green when the portable memory is set; blinks up orange while accessing the portable memory.

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2.2 Rear panel

2.2

Rear panel

Ch.2 1

2

3

4

5

6

No.

Nomenclature

1

SDI IN terminal

Connect the video system center.

2

SDI OUT1 terminal

Connect the following devices.

7

8

Description

• Monitor • Video recorder 3

SDI OUT2 terminal

Connect the following devices. • Monitor • Video recorder

4

Potential equalization terminal

This terminal is connected to a potential equalization terminal of the other equipment connected to the Endoscopy CAD system. The electric potential of their equipment is made equal.

5

1000BASE-T terminal

This terminal cannot be used because this is used exclusively by Olympus service personnel for maintenance.

6

LINK OUT terminal

Connect the equipment having the LINK-IN and LINK-OUT terminals can be daisy-chained.

7

LINK IN terminal

Connect the video system center.

8

AC power inlet

Connects the provided power cord to supply the AC power via this inlet.

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2.3 Side panels

2.3

Side panels

Ch.2 1

No.

Nomenclature

Description

1

Ventilation grilles

Prevent the internal temperature of endoscopy CAD system from rising by ventilating.

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