CLV-190 EVIS EXERA III Xenon Light Source Instructions Nov 2021

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 ... 5 Instrument compatibility ... 6 Repair and modification ... 6 Signal words ... 6 Dangers, warnings, and cautions ... 7 Cardiac applications ... 11

Summary of the Equipment Functions ... 12

Chapter 1 Checking the Package Contents ... 15 1.1

Checking the package contents list ... 15

Chapter 2 Nomenclature and Functions ... 17 2.1

Nomenclature and functions ... 17

2.2

Front panel ... 19

2.3

Rear and side panels ... 24

Chapter 3 Installation and Connection ... 27 3.1

Precautions for installation and connection ... 27

3.2

Installation workflow ... 28

3.3

Installation of equipment ... 29 Installation on the mobile workstation (WM-NP2, WM-DP2, WM-NP1, WM-WP1, or WM-DP1) ... 30 Installation in another location ... 32

3.4

Installation of the water container ... 33

3.5

Selection of the lamp ignition mode ... 33 Manual ignition (MANU) ... 34 Automatic ignition (AUTO) ... 34

3.6

Connection of the video system center ... 35

3.7

Connection of the foot switch ... 38

3.8

Connection to the AC mains power supply ... 39

CLV-190 INSTRUCTION MANUAL

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Contents

Chapter 4 Inspection ... 41 4.1

Precautions for inspection ... 41

4.2

Inspection workflow ... 42

4.3

Checking the lamp ignition mode ... 43

4.4

Connection of an endoscope ... 43

4.5

Inspection of the power supply ... 46

4.6

Checking the lamp usage indicator ... 48

4.7

Inspection of the examination light ... 48

4.8

Inspection of the brightness mode selection function ... 50

4.9

Inspection of brightness adjustment ... 51 Inspection of automatic brightness adjustment ... 51 Inspection of manual brightness adjustment ... 54

4.10 Inspection of the optical-digital observation function ... 56 4.11 Inspection of the transillumination function ... 58 4.12 Inspection of the high intensity mode ... 59 4.13 Inspection of air and water feeding ... 62 4.14 After inspection ... 64

Chapter 5 Operation ... 65 5.1

Attention to operation ... 65

5.2

Operation workflow ... 68

5.3

Turning the light source ON and igniting the examination lamp ... 69

5.4

Setting the brightness mode ... 70

5.5

Brightness adjustment ... 71 Automatic brightness adjustment ... 71 Manual brightness adjustment ... 73

5.6

Optical-digital observation ... 74

5.7

Transillumination function ... 76

5.8

High intensity mode ... 77

5.9

Air/water feeding ... 78

5.10 Extinguishing the examination lamp ... 79 5.11 Turning the light source OFF ... 80

Chapter 6 Lamp Replacement ... 81

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6.1

Replacement of the examination (xenon) lamp ... 81

6.2

Removal of the lamp ... 82

6.3

Insertion of the lamp ... 86

6.4

Lamp usage indicator reset ... 91 CLV-190 INSTRUCTION MANUAL

Contents

Chapter 7 Reprocessing, Storage, Disposal, and Transportation ... 93 7.1

Reprocessing ... 93

7.2

Surface disinfectant cleaner ... 95

7.3

Signs of degradation from reprocessing ... 96

7.4

Preparing equipment for reprocessing ... 97 Equipment needed ... 97

7.5

Reprocessing the light source and accessories ... 98

7.6

Storage ... 101

7.7

Disposal ... 101

7.8

Transportation ... 101

Chapter 8 Troubleshooting ... 103 8.1

Troubleshooting ... 103

8.2

Troubleshooting guide ... 103

8.3

Returning the light source for repair ... 108

Appendix ... 109 Combination equipment ... 109 System chart ... 109 Water container ... 112

Transportation, storage, and operating environments ... 113 Specifications ... 113 EMC information ... 117

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Contents

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CLV-190 INSTRUCTION MANUAL

Labels and Symbols

Labels and Symbols Safety-related labels and symbols are attached to the light source at the locations shown below. If labels or symbols are missing or illegible, contact Olympus.

 Rear and side panel CSA/UL marking Blue

Cautions that the inside is extremely hot immediately after the lamp is extinguished.

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

Lamp model number

Electrical rating POWER INPUT 100 – 240V 50/60 Hz 600 VA Manufacturer name

Blue

CE marking

Indicates to see the instruction manual for replacement of the examination lamp.

Serial number

Date of manufacture

Crossed-out wheeled bin’ symbol

Potential equalization terminal

Product name

CLV-190 INSTRUCTION MANUAL

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Labels and Symbols

 Front panel

Dry the endoscope connector before insertion.

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

Translation

Importer (into European Union)

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CLV-190 INSTRUCTION MANUAL

Important Information - Please Read Before Use

Important Information - Please Read Before Use

 Intended use The light source is intended to be used with Olympus endoscopes, video system centers, and other ancillary equipment for endoscopic diagnosis, treatment and video observation. Do not use the light source for any purpose other than its intended use.

 Applicability of endoscopy and endoscopic treatment If there are official standards on the applicability of endoscopy and endoscopic treatment that are defined by the hospital’s administrators or other official institutions, such as academic societies on endoscopy, follow those standards. 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.

 Instruction manual This instruction manual contains essential information on using the light source 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 Video system center: The video system center is a device that converts signals from a videoscope, video converter, or camera head into monitor images.

Video converter: The video convertor is a device that connects to a video system center to convert images from a fiber endoscope into monitor images.

Camera head: The camera head is a device that connects to a video system center to convert images from a fiber endoscope or rigid endoscope into monitor images.

Mobile workstation: The mobile workstation is a special trolley to place the light source and other devices.

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 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.

Transillumination function: With this function, the distal end of the endoscope emits more intense examination light, which transmits the body wall of the patient and enables the operator to confirm the position of the distal end from outside the patient’s body, provided that the operating room illumination is low.

High intensity mode: This mode emits brighter illumination light than usual. It is available only with the endoscopes and light guide cables compatible with this mode.

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CLV-190 INSTRUCTION MANUAL

Important Information - Please Read Before Use

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

Optical-digital observation: This is observation using specific filtered light.

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

 User qualifications If there are official standards for user qualifications to perform endoscopy and endoscopic treatment that are defined by the hospital’s medical administrators or other official institutions, such as academic societies on endoscopy, follow those standards. If there are no official qualification standards, 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.

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Important Information - Please Read Before Use

 Instrument compatibility Refer to the “ System chart” on page 109 to confirm that the light source 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 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 light source does not contain any user-serviceable parts. Do not disassemble, modify or attempt to repair it; patient or user 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. The light source is to be repaired by Olympus technicians only.

 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

6

Indicates additional helpful information.

CLV-190 INSTRUCTION MANUAL

Important Information - Please Read Before Use

 Dangers, warnings, and cautions Follow the dangers, warnings, and cautions given below when handling the light source. 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 an electric shock. − When the light source 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. − If fluids are spilled on or into the light source, stop operation of the light source immediately and contact Olympus. − Do not prepare, inspect, or use the light source with wet hands. • Never install and operate the light source 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 nearby.

WARNING • In case of light source failure or malfunction, always keep another light source in the room ready for use. • Never insert anything into the ventilation grills of the light source. It can cause an electric shock. • Do not look directly into the distal end of the endoscope, the distal end of the light guide cable, or the output socket of the light source when they are emitting light. The intense light may cause eye injury. • Do not touch the distal end of the endoscope connector of the endoscope, distal end of the light guide connector of the endoscope, distal end of the light guide cable, or output socket of the light source immediately after disconnecting it from the light source because they are extremely hot. Operator or patient injury can result.

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Important Information - Please Read Before Use

WARNING • Although the examination 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 about 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 electrical shutter function, pay attention to the brightness level setting of the light source. When the light source is used with a video system center compatible with automatic brightness adjustment function, be sure to use this function. The automatic brightness adjustment can keep the illumination at a proper level. Refer to the instruction manual for the video system center for details. − Do not continue observation in the proximity of tissue or keep the distal end of the endoscope in contact with living tissue for a long time. − When discontinuing the use of the endoscope, be sure to turn the light source OFF or extinguish the examination lamp by pushing the lamp button. • Since the light source irradiates strong examination light, the disconnected end of the light guide cable or the distal end of the endoscope becomes very hot. To prevent a fire hazard, 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 no examination is performed, be sure to turn the light source OFF or extinguish the examination lamp by pushing the lamp button. • If the endoscopic image dims during use, blood, mucus, or debris may have soiled the light guide on the distal end of the endoscope. Carefully withdraw the endoscope from the patient and remove the blood or mucus to obtain optimum illumination and to ensure the safety of the examination. If you continue to use the endoscope in such a condition, the distal end temperature may rise and cause mucosal burns. It may also cause patient and/or operator injury. • The light source may interfere with other medical electronic equipment used in combination with it. Before use, refer to the Appendix to confirm the compatibility of the light source with all equipment to be used. • Do not use the light source in locations exposed to strong electromagnetic radiation (e.g., in the vicinity of a microwave therapeutic device, MRI, short-wave therapeutic device, radio equipment, or cellular/portable phone). This may impair the performance of the light source. • Do not touch the output connector of the light source. Operator or patient injury can result.

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CLV-190 INSTRUCTION MANUAL

Important Information - Please Read Before Use

WARNING • Do not connect any object other than the light guide and an endoscope to the output connector. Otherwise, malfunction may result. • Do not rely on the optical-digital observation mode alone for primary detection of lesions or for a decision regarding any potential diagnostic or therapeutic intervention. • Be sure that the light source is not used adjacent to or stacked with other equipment (other than the components of the light source or system) to avoid electromagnetic interference. • Electromagnetic interference may occur on the light source 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 the light source, or shielding the location.

CAUTION • Do not use a pointed or hard object to press the buttons on the front panel. This may damage the buttons. • Do not touch the electrical contacts inside the light source’s connectors. • Do not simultaneously touch any of the exposed electrical contact pins and the patient. It may pose a risk of electric shock to the patient and/or user. • Do not apply excessive force to the light source and/or other instruments connected. Otherwise, damage and/or malfunction can occur. • Do not leave the examination lamp ON when an endoscope is connected to the light source. The examination light reaches the maximum intensity and the endoscope’s distal end becomes hot. In addition, smoke may also be produced if the debris attached to the distal end is heated. • If the emergency lamp, instead of the examination lamp, lights up frequently when pressing the lamp button to light the examination lamp, the light source may have already malfunctioned. Return the light source for repair, following Section 8.3, “Returning the light source for repair”. • Avoid using the light source in a dusty environment. This may damage the light source. • Do not position the medical device so that it is difficult to disconnect it from the wall mains outlet.

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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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CLV-190 INSTRUCTION MANUAL

Important Information - Please Read Before Use

 Cardiac applications DANGER • Use only the devices listed in the “ System chart” on page 109 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 OLYMPUS light guide cables and camera heads listed in the “ System chart” on page 109 (TYPE CF applied part) that are suitable for cardiac applications bear a mark. • The Olympus 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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Summary of the Equipment Functions

Summary of the Equipment Functions Some of the functions described below may be unavailable or restricted depending on the combined equipment. For more details, refer to the instruction manuals for the light source and the required ancillary equipment.

 Providing the examination light The light of the examination lamp built into the light source is provided to the endoscope. → Section 5.3, “Turning the light source ON and igniting the examination lamp”

 Adjusting the examination light When the light source is used in combination with the video system center, a videoscope, and camera head, the examination light intensity is adjusted automatically. When the light source is used in combination with a fiber endoscope, the examination light intensity has to be adjusted manually. → Section 5.5, “Brightness adjustment”

 Optical-digital observation NBI observation is available as an optical-digital observation mode. → Section 5.6, “Optical-digital observation”

 Transillumination function The endoscope’s distal end emits the intense light. The light transmits the patient’s body wall so that the operator can confirm the position of the distal end from outside the patient’s body provided that the operating room illumination is low. → Section 5.7, “Transillumination function”

 Selecting the high intensity mode Brighter examination light is available when using an endoscope and light guide that are compatible with high intensity mode operation. → Section 5.8, “High intensity mode”

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CLV-190 INSTRUCTION MANUAL

Summary of the Equipment Functions

 Air and water feed The light source incorporates an air pump and an external water feed tank to feed air and water from the nozzle at the endoscope’s distal end into the body cavity, and the air/water flow can be adjusted. → Section 5.9, “Air/water feeding”

 Monitoring the operating hours of the examination lamp The lamp usage indicator on the front panel of the light source displays the total accumulated operation hours of the examination lamp to indicate the time for replacement. → Section 4.6, “Checking the lamp usage indicator”

 Automatic switching to the emergency lamp If the examination lamp does not light up or blows in the middle of an examination making endoscopic observation impossible, the light source switches automatically to the emergency light. The emergency light provides enough brightness for withdrawing the endoscope from the patient’s body.

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Summary of the Equipment Functions

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CLV-190 INSTRUCTION MANUAL

1.1 Checking the package contents list

Chapter 1

1.1

Checking the Package Contents

Checking the package contents list

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

 Light source

EVIS EXERA III xenon light source (CLV-190)

 Accessories

Digital light source cable (MAJ-1933)

Light source cable (MAJ-1941)

Foot holders (MAJ-1205, 4 pcs.)

Power cord

Water container (MAJ-901)

Instruction manual

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Ch.1