CLL-S700 VISERA ELITE III LED Light Source Instructions July 2022

Contents

Contents Labels and Symbols ... 1 Important Information - Please Read Before Use ... 3 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 Classification of safety of optical radiation ... 6 Signal words ... 6 Precautions ... 7 Precautions for use on and near the cardiac area ... 10 About Security ... 11

Summary of Equipment Functions ... 12

Chapter 1 Checking the Package Contents ... 13 1.1

Checking the package contents ... 13

Chapter 2 Nomenclature and Functions ... 15 2.1

Symbols and descriptions ... 15

2.2

Front panel ... 16

2.3

Rear panel ... 17

2.4

Side panels ... 18

Chapter 3 Installation and Connection ... 19 3.1

Precautions for installation and connection ... 19

3.2

Installation workflow ... 20

3.3

Installation of the equipment ... 21 Installation of the CLL-S700 ... 22

3.4

Connection to the AC mains power supply ... 25 When the mobile workstation is used ... 26 When no mobile workstation is used ... 27

3.5

Connection of the video system center ... 27 Compatible video system center ... 27 Connect the video system center ... 27

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Contents

Chapter 4 Inspection ... 29 4.1

Precautions of workflow ... 29

4.2

Inspection workflow ... 30

4.3

Connection of an endoscope ... 31

4.4

Inspection of the power supply ... 33

4.5

After inspection ... 34

Chapter 5 Operation ... 35 5.1

Precautions for operation ... 35

5.2

Operation workflow ... 37

5.3

Turning the LED light source ON ... 38

5.4

Termination of the operation ... 39

5.5

Transportation ... 40

Chapter 6 Reprocessing, Storage, and Disposal ... 41 6.1

Reprocessing ... 41 Surface disinfectant cleaner ... 42 Signs of degradation from reprocessing ... 43 Preparing equipment for reprocessing ... 43 Reprocessing procedure ... 44

6.2

Storage ... 46

6.3

Disposal ... 47

Chapter 7 Troubleshooting ... 49

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7.1

Troubleshooting ... 49

7.2

Troubleshooting guide ... 50

7.3

Returning the LED light source for repair ... 51

CLL-S700 INSTRUCTION MANUAL

Contents

Appendix ... 53 Combination equipment ... 53 System chart ... 53

Specifications ... 56 Environment ... 56 Specifications ... 56

Security information of this instrument ... 59 Introduction ... 59 Usable peripheral devices ... 59 Maintenance of security function ... 59

EMC information ... 60 Open Source Software license information of this instrument ... 66 GNU GPL ... 66 BSD ... 66

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Contents

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CLL-S700 INSTRUCTION MANUAL

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. VISERA ELITE III LED LIGHT SOURCE MODEL OLYMPUS CLL-S700 POWER INPUT: 100–240V 50/60 Hz 215VA

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

Authorized representative in the European Community CE marking

OTV

Manufacturer

LINK OUT

MEDICAL DEVICE medical device

Potential equalization terminal

Manufacture date

CLL-S700 INSTRUCTION MANUAL

Crossed-out wheeled bin’ symbol

Serial number

1

Labels and Symbols

 Front panel Yellow

Blue

Indicates to refer to the instruction manual for action to avoid optical hazard. For detail, “ Classification of safety of optical radiation” on page 6.

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

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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CLL-S700 INSTRUCTION MANUAL

Important Information - Please Read Before Use

Important Information - Please Read Before Use

 Intended purpose This light source is intended to provide light to a endoscope/video endoscope in order to process electronic signals transmitted from them and output image signal to monitor, and to be used with Olympus endoscopes, video endoscopes, camera heads, video system center, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

 Contraindications As a TYPE BF applied part, the endoscope connected to this LED light source 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 LED 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 the endoscope connected to this LED light source.

 Clinical benefit Supports to achieve the clinical benefit of connected endoscopes, video system center, camera heads and other ancillary equipment by providing endoscopic diagnosis, treatment, and observation.

 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. CLL-S700 INSTRUCTION MANUAL

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Important Information - Please Read Before Use

 Instruction manual This instruction manual contains essential information on using this product 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 system center: The video system center is a device that processes the signal from the endoscope and sends the endoscopic image to the monitor.

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

Mobile workstation: The mobile workstation is a specialized trolley that for endoscopic diagnosis and procedures with system equipment such as this product.

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.

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

YE (Yellow Enhance) observation: This is observation which emphasizes the yellow color of the WLI observation.

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

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

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CLL-S700 INSTRUCTION MANUAL

Important Information - Please Read Before Use

 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 surgical 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.

 Instrument compatibility Refer to “ System chart” on page 53 to confirm that the LED light source 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 LED light source 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 7, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 7, 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 LED light source is Risk Group 2 product.

 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.

CLL-S700 INSTRUCTION MANUAL

Important Information - Please Read Before Use

 Precautions Follow the warnings and cautions given below when handling the LED light source. This information is to be supplemented by the 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 LED 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. − Keep fluids away from all electrical equipment. If fluids are spilled on or into the unit, stop operation of the LED light source immediately and contact Olympus. − Do not prepare, inspect, or use the LED light source with wet hands. • Never install and operate the LED light source in locations where: − The concentration of oxygen is high; − Oxidizing agents (such as nitrous oxide (N2O)) are present in the atmosphere; − Flammable gases are present in the atmosphere; − Flammable liquids are near. Otherwise, an explosion or a fire may result because the LED light source is not explosion-proof.

WARNING • Do not use this instrument for any purpose other than its “ Intended purpose” on page 3. • In case of LED light source failure or malfunction, always keep another LED light source ready for use. • 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 use the LED light source 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 LED light source. • Do not apply excessive force to the LED light source and/or other instruments connected. Otherwise, damage and/or malfunction can occur.

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Important Information - Please Read Before Use

WARNING • This product may interfere with other medical electronic equipment used in combination with it. Before use, refer to “ System chart” on page 53 to confirm the compatibility of the LED light source with all equipment to be used. This may result in loss of live images or malfunction of the product. • Solistically observation and diagnosis should be performed not only NBI observation but also normal light observation for all observation sites. Correct observation and diagnosis may not be possible. The information obtained from NBI observation is for reference information and does not guarantee the validity of the diagnosis. • When removing the camera head from the endoscope with the illumination lamp on, be sure to set the dimming mode display to “manual” and set minimize the brightness with the brightness adjustment button. If you remove the endoscope with the dimming mode display set to “Auto”, automatic dimming fail to function and you may get burn or h eye injury. • 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. • Although the illumination light emitted from the distal end of the endoscope, the distal end of the light guide cable, are required for endoscopic observation and treatment, it may also cause alteration of living tissues such as protein denaturation of biological tissue by inappropriate use. Observe the following warnings on 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. − Do not continue observation in proximity to tissue or keep the distal end of the endoscope in contact with living tissue for a long time. − When discontinuing the use of the endoscope, extinguish the lamp by tapping the lamp button.

CAUTION • Never insert anything into the ventilation grilles of the LED light source. It can cause an electric shock and/or a fire. • Do not allow the distal end of an endoscope or distal end of a light guide, which emits illumination light, to contact with flammable materials such as operating room drapes for a ling time. Patient injury and/or a fire can result. • Do not touch the light guide of the endoscope or the output socket of the LED light source immediately after disconnecting it from the LED light source because they are extremely hot. Operator or patient injury can result.

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CLL-S700 INSTRUCTION MANUAL

Important Information - Please Read Before Use

CAUTION • If the endoscopic image dims during use, blood, mucus, or debris may have adhered to the light guide cable 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. • 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. • Use the LED light source only under the conditions described in “ Environment” on page 56. Otherwise, improper performance, compromised safety, and/or equipment damage may result. • Do not allow a foreign object to penetrate the inside of the output socket, and terminals on the rear panel. The LED light source may malfunction. • 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 LED light source’s connectors by hands. Equipment damage and/or malfunction may result. • Avoid using the LED light source in a dusty environment. This may damage the LED light source. • 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. • Confirm that there is no dust on the ventilation grilles. Clean and vacuum dust from the ventilation grilles using a vacuum cleaner, when necessary. Otherwise, the LED light source may break down and get damaged from overheating.

NOTE • 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.

• 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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Important Information - Please Read Before Use

 Precautions for use on and near the cardiac area DANGER 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, an 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, devices directly connected to the endoscope, such as the light guide cable, camera head, and telescope holder, must individually meet the “TYPE CF applied part” requirements for leakage current limits.

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CLL-S700 INSTRUCTION MANUAL

Important Information - Please Read Before Use

 About Security For security information of this instrument, refer to “Security information of this instrument” on page 59.

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Summary of Equipment Functions

Summary of Equipment Functions This product provides illumination for the endoscope in combination with our specified video processor.

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CLL-S700 INSTRUCTION MANUAL

1.1 Checking the package contents

Chapter 1

1.1

Checking the Package Contents

Checking the package contents

Ch.1

Check to see if all items in the package match the following and check the all items for damage. If the LED light source is damaged, a component is missing, or you have any questions, do not use the LED light source; immediately contact Olympus.

 LED light source

VISERA ELITE III LED LIGHT SOURCE (CLL-S700)

 Accessories

Light source cable (MAJ-2508)

Foot holder (MAJ-1205, 4 pcs. with a pattern)

Installation manual

Quick reference guide

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1.1 Checking the package contents

Ch.1

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CLL-S700 INSTRUCTION MANUAL

2.1 Symbols and descriptions

Chapter 2

2.1

Nomenclature and Functions

Symbols and descriptions

 Front panel Symbol

Ch.2 Description

Power ON/OFF

Symbol

Blue

Description Refer to instructions.

Optical radiation

 Rear panel Symbol

Description

Symbol

Description

Serial number

Equipotential terminalzz

Refer to instructions.

Alternating current

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