CLV-S400 VISERA 4K UHD XENON LIGHT SOURCE Instructions Feb 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 ... 5 Instrument compatibility ... 5 Repair and modification ... 5 Signal words ... 6 Precautions ... 6

Summary of the Equipment Functions ... 10

Chapter 1 Checking the Package Contents ... 11 1.1

Checking the package contents list ... 11

Chapter 2 Nomenclature and Functions ... 13 2.1

Nomenclature and functions ... 13

2.2

Front panel ... 15

2.3

Rear panel ... 18

2.4

Side panel ... 19

Chapter 3 Installation and Connection ... 21 3.1

Precaution for installation and connection ... 21

3.2

Installation workflow ... 22

3.3

Installation of equipment ... 23 Installation on the mobile workstation (WM-NP2) ... 24 Installation in another location ... 25

3.4

Connection of the camera control unit ... 26

3.5

Connection to the AC mains power supply ... 27

Chapter 4 Inspection ... 29 4.1

Warnings: inspection ... 29

4.2

Inspection workflow ... 30

4.3

Connection of an endoscope ... 31

4.4

Inspection of power ON ... 32

4.5

Inspection of the lamp usage indicator ... 35

4.6

Inspection of the examination light ... 36 CLV-S400 INSTRUCTION MANUAL

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Contents

4.7

Inspection of the brightness mode selection ... 38

4.8

Inspection of brightness adjustment ... 39 Inspection of automatic brightness adjustment ... 39 Inspection of manual brightness adjustment ... 42

4.9

Inspection of the NBI observation ... 44

4.10 Inspection of the high intensity mode ... 45 4.11 After inspection ... 47

Chapter 5 Operation ... 49 5.1

Warnings: operation ... 49

5.2

Operation workflow ... 52

5.3

Turning ON the light source and igniting the examination lamp ... 53

5.4

Setting the brightness mode ... 54

5.5

Adjusting the brightness ... 55 Automatic brightness adjustment ... 55 Manual brightness adjustment ... 57

5.6

Using the NBI observation ... 58

5.7

Using the high intensity mode ... 59

5.8

Extinguishing the examination lamp ... 60

5.9

Turn OFF the light source ... 61

Chapter 6 Lamp Replacement ... 63 6.1

Replacement of the examination (xenon) lamp ... 63

6.2

Removal of the lamp ... 64

6.3

Insertion of the lamp ... 67

6.4

Lamp usage indicator reset ... 72

Chapter 7 Reprocessing, Storage, Disposal, and Transportation ... 75 7.1

Reprocessing ... 75 Surface disinfectant cleaner ... 77 Signs of degradation from reprocessing and maximum number of reprocessing ... 78 Preparing equipment for reprocessing ... 79 Reprocessing the light source (CLV-S400) ... 80

7.2

Storage ... 83

7.3

Disposal ... 84 Examination lamp ... 84 The light source or any of its components ... 85

7.4

Transportation ... 85

Chapter 8 Troubleshooting ... 87 ii

CLV-S400 INSTRUCTION MANUAL

Contents

8.1

Troubleshooting ... 87

8.2

Troubleshooting guide ... 88

8.3

Returning the light source for repair ... 91

Appendix ... 93 Combination equipment ... 93 System chart ... 93

Specifications ... 95 Environments ... 95 Specifications ... 96

EMC information ... 99 License information of Open Source Software ... 105 GNU GPL ... 105 End User License Agreement of Open Source Software modules ... 105 Others ... 106 newlib ... 106

CLV-S400 INSTRUCTION MANUAL

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Contents

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CLV-S400 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 Product name VISERA 4K UHD XENON LIGHT SOURCE MODEL OLYMPUS CLV-S400 Authorized representative in the European Community

Medical device MEDICAL DEVICE

CE marking

Potential equalization terminal Manufacturer

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

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

Blue

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

Lamp model number Crossed-out wheeled bin’ symbol Serial number plate Electrical rating POWER INPUT 100 – 240V

Date of Manufacture Manufacturer name

50/60Hz 500VA

CLV-S400 INSTRUCTION MANUAL

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Labels and Symbols

 Front panel

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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CLV-S400 INSTRUCTION MANUAL

Important Information - Please Read Before Use

Important Information - Please Read Before Use

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

 Contraindications As a TYPE BF applied part, this light source 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 light source 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 light source.

 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 are official standards on the applicability of endoscopy and endoscopic treatment that are defined by the administrators of healthcare facility 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.

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Important Information - Please Read Before Use

 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 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 Camera control unit: The camera control unit is a device that receives the electrical signals from a camera head and displays the endoscopic images on the monitor.

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

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 an 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.

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

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

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CLV-S400 INSTRUCTION MANUAL

Important Information - Please Read Before Use

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

 User qualifications This instrument should be used by persons trained in the use of this instrument. If there are official standards on user qualifications to perform endoscopy and endoscopic treatment that are defined by the medical administrators of healthcare facility or other official institutions, such as academic society on endoscopy, endoscopy and endoscopy physicians follow those standards. If there are no official qualification standards, the operator of this light source 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 safely 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 the “ System chart” on page 93 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 light source complies with the EMC standard for medical electrical equipment, edition 3 (IEC 60601-1-2: 2007) and edition 2 (IEC 60601-1-2: 2001), edition 4 (IEC 60601-1-2: 2014). However, when connected to an instrument that complies with the EMC standard for medical electrical equipment, edition 1 (IEC 60601-1-2: 1993), the whole system complies with edition 1.

 Repair and modification The light source does not contain any user-serviceable parts. Do not disassemble, modify, or attempt to repair the light source; 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.

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Important Information - Please Read Before Use

 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.

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

WARNING • Strictly observe the following warnings. 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 the light source 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. • 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 light source. It can cause an electric shock.

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CLV-S400 INSTRUCTION MANUAL

Important Information - Please Read Before Use

WARNING • 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 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. • 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 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 light source is used with a camera control unit 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 camera control unit 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 disconnected end of the light guide cable or 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.

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Important Information - Please Read Before Use

WARNING • 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 rely on the NBI observation mode alone for primary detection of lesions or for a decision regarding any potential diagnostic or therapeutic intervention. • When disconnecting the camera head from the endoscope with the examination lamp ON, set the brightness mode to “MANU” and set the examination light intensity to the minimum level. If the camera head is disconnected while the brightness mode is “AUTO”, the intense light may injure your eyes.

CAUTION • Do not connect any object other than a light guide cable to the output socket. Malfunction may result. • Do not use a pointed or hard object to press the buttons on the front panel. This may damage the buttons. • Do not apply excessive force to the light source and/or other instruments connected. 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. • 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 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.

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CLV-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.

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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 ON the light source and igniting the examination lamp”

 Adjusting the examination light When the light source is used in combination with the camera control unit and camera head, the examination light intensity is adjusted automatically. →Section 5.5, “Adjusting the brightness”

 Selecting the NBI observation mode NBI observation is available. →Section 5.6, “Using the NBI observation”

 Selecting the high intensity mode Brighter examination light is available when using a light guide cable that is compatible with high intensity mode operation. →Section 5.7, “Using the high intensity mode”

 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 4.5, “Inspection of 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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CLV-S400 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 component packaging 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

VISERA 4K UHD xenon light source (CLV-S400)

 Accessories

Light source cable (MAJ-1941)

Foot holders (MAJ-1205, 4 pcs.)

Power cord

Instruction manual

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Ch.1

1.1 Checking the package contents list

Ch.1

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CLV-S400 INSTRUCTION MANUAL

2.1 Nomenclature and functions

Chapter 2

2.1

Nomenclature and Functions

Nomenclature and functions

 Front panel Symbol

Description

Symbol

Description

Power ON/OFF

Brightness

Decrease brightness

Increase brightness

Exchange lamp (Lamp usage indicator)

Counter reset (Lamp usage indicator reset)

New lamp (Lamp usage indicator)

Spare lamp (Emergency lamp)

Examination lamp ignition

Mode select

High intensity mode

Observation mode

Ch.2

TYPE BF applied part

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2.1 Nomenclature and functions

 Rear and side panels Symbol

Description

MEDICAL DEVICE

Warns that the lamp is hot.

Serial number

Potential equalization terminal

Blue

Refer to instructions

Lamp model number

Authorized representative in the European Community

Medical device

Manufacturer

Date of Manufacturer

14

Description

Refer to instructions.

Alternating current

Ch.2

Symbol

CLV-S400 INSTRUCTION MANUAL

2.2 Front panel

2.2

Front panel 2

1

4

3

Ch.2

5

5

No.

Nomenclature

Description

1

Power switch

Press to turn the light source ON or OFF.

2

Power indicator

Lights up when the light source is ON.

3

Output socket

Connect the light guide cable to this socket. This socket provides the endoscope with light.

4

Control panel

Refer to the next page.

5

Foot

Fit the Feet into the foot holders.

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