BL-7000 Light Source Operation Manual Rev D



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Contents at a Glance Introduction Read and understand this manual fully before using this product. Chapter 1

Precautions This chapter describes the warnings and cautions for safe operation of this product.

Chapter 2

Components and System Configuration of BL-7000 This chapter describes the composition of the endoscope set of accessories and system configuration.

Name and Function of Each Part

Contents at a Glance

Chapter 3

This chapter describes the name and function of each part of this product. Chapter 4

Installation and Connection of the Equipment and Peripherals This chapter describes the installation and connection methods of the equipment and peripherals.

Chapter 5

Preparation and Inspection of the System This chapter describes the inspection and preparation methods to be performed for using this product.

Chapter 6

Method of Use This chapter describes a series of operations of this product.

Chapter 7

Storage and Maintenance This chapter describes the methods of storage and maintenance of this product.

Chapter 8

Troubleshooting This chapter describes actions should be taken if problems occur in this product.

Chapter 9

Main Specification This chapter describes the main specification of this product.

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Contents

Contents Contents at a Glance... iii

Introduction

1

About This Manual...1 ♦ Operation Manuals...1 How to Read This Manual...3 ♦ Conventions Used in This Manual...3

Chapter 1 1.1

Precautions

1-1

Safety...1-1 ♦ Category of Equipment...1-1

1.2

1.1.1

Warnings...1-2

1.1.2

Direct Harm to Human Body...1-2

Cautions/Warnings...1-3 1.2.1

Intended Use...1-3

1.2.2

Clinical Procedures...1-3

1.2.3

Loss of Function...1-4

1.2.4

Combination of Equipment...1-4

1.2.5

Electric Shock...1-4

1.2.6

Explosion...1-4

1.2.7

Maintenance...1-5

1.2.8

Preparation and inspection before use...1-5

1.2.9

Installation of Equipment...1-5

1.2.10 Handling...1-5 1.2.11 Foreign Matter and Liquid...1-6 1.2.12 Disposal...1-6 1.2.13 Software Version...1-6 1.2.14 Temperature at distal end...1-6 1.2.15 Electromagnetic interference...1-7

Chapter 2 2.1

Components and System Configuration of BL-7000

2-1

Components of BL-7000...2-1 ♦ BL-7000 Components...2-1

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2.2

Standard System Configuration...2-2

2.3

System Expansion...2-4

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Chapter 3

Name and Function of Each Part

3-1

3.1

Front Panel...3-1

3.2

Rear Panel...3-3

3.3

Left Side Panel...3-4

3.4

Bottom...3-5

3.5

Warning Labels...3-6 ♦ Caution Label...3-6

3.6

Rating Plate...3-6

3.7

Symbols...3-7

Chapter 4

Installation and Connection of the Equipment and Peripherals 4-1

4.1

Attaching the Louver...4-1

5.1

Preparation and Inspection of the System

Contents

Chapter 5

5-1

Installing and Connecting the Equipment...5-1 5.1.1

Installing the Endoscope and Water Tank...5-1 ♦ 700 System Scope...5-2 ♦ 600 System Scope and 500 System Scope...5-2

5.1.2

Chapter 6

Method of Use

6-1

6.1

Turning On the Light...6-2

6.2

Adjusting the Brightness...6-4

6.3

Operation of Air Supply Pump...6-5

6.4

Transmitted Illumination...6-6

6.5

Light Save...6-7

6.6

Light Mode...6-8

6.7

Turning Off the Light...6-8

6.8

Turning Off the Power...6-9

Chapter 7

Storage and Maintenance

7-1

7.1

Care after Use...7-1

7.2

Cleaning the Filter...7-2

7.3

Storage...7-3 7.3.1

Storage of Light Source...7-3

7.3.2

Storage of Water Tank...7-3

7.4

Relocation...7-4

7.5

When the Light Source Status Lamp Flashes...7-6

7.6

Cleaning and Disinfecting (or Sterilizing) the Water Tank...7-8

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Operation Check of Light Source...5-4

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Contents

Chapter 8

Troubleshooting

8-1

8.1

Troubleshooting...8-1

8.2

Error Messages...8-5

Chapter 9 9.1

Main Specification

9-1

Specification...9-1 ♦ Classification of Medical Electrical Equipment...9-1 ♦ Applied Part...9-1 ♦ Specification...9-1 ♦ Operating Environment...9-2 ♦ Transport and Storage Environment...9-2 ♦ Term of Validity/Period for Use (Durability)...9-2 ♦ Input/Output Connector...9-2 ♦ Block Diagram...9-2 ♦ Medical Device Directive...9-3

9.2

Electromagnetic Compatibility (EMC) Information...9-4

9.3

After-Sales Service...9-8

9.4

Disposal of Electric and Electronic Equipment...9-9

Index ...9-10 Service Centers...9-11

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Introduction Read and understand this manual carefully before operating this product.

About This Manual This manual describes how to use and store the light source BL-7000.

Introduction

BL-7000 is used with the processor VP-7000. For details on how to use this system and combined equipment, refer to the VP-7000 operation manual.

♦ Operation Manuals Manage and store the operation manuals related to this product together as a set.

Processor VP-7000 Operation Manual This manual provides necessary information for using the processor such as the equipment overview, operation procedures and precautions to observe.

Light Source BL-7000 Operation Manual This manual provides necessary information for using the light source such as the equipment overview, operation procedures and precautions to observe.

Note

This product is used in combination with peripherals. Refer to the operation manual of each peripheral device described in the VP-7000 Operation Manual, “2.2 Equipment Using in Combination”.

Trademarks The company names and product names described in this manual are trademarks or registered trademarks of FUJIFILM Corporation or its subsidiaries. Other holders’ trademarks All other company names and product names described in this manual are trademarks or registered trademarks of their respective owners. Copyright © 2015-2016 FUJIFILM Corporation. All rights reserved.

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Introduction

CAUTION • No part or all of this manual may be reproduced in any form without prior permission. • The information contained in this manual may be subject to change without prior notice. • FUJIFILM Corporation shall not be liable for malfunctions or damages caused by installation, relocation, remodeling, maintenance, and repair performed by dealers other than those specified by FUJIFILM Corporation. • FUJIFILM Corporation shall not be liable for malfunctions or damages of FUJIFILM Corporation products due to products of other manufacturers not supplied by FUJIFILM Corporation. • FUJIFILM Corporation shall not be liable for malfunctions or damages caused by remodeling, maintenance, and repair using repair parts other than those specified by FUJIFILM Corporation. • FUJIFILM Corporation shall not be liable for malfunctions or damages resulting from negligence of the precautions and operating methods contained in this manual. • FUJIFILM Corporation shall not be liable for malfunctions or damages resulting from use under environment conditions outside the range specified for this product, such as the power supply, installation environment, etc., as described in this manual. • FUJIFILM Corporation shall not be liable for malfunctions or damages resulting from natural disasters, such as fires, earthquakes, floods, lightning, etc.

• This product has heavy metal parts. When disposing of this product, comply with local laws and regulations in your area. Determine whether or not the product is to be treated as a biohazard, then handle and dispose of accordingly. • Before disposing of this product or an endoscopic accessory, perform cleaning and disinfection (or sterilization) according to the procedure described in the operation manual. There is a risk of being a source of infection.

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How to Read This Manual ♦ Conventions Used in This Manual This manual uses the following conventions for easier understanding. General Conventions Description

WARNING

Explains dangerous situations that may cause death or serious injury if not avoided.

CAUTION

Explains situations that may cause slight or moderate levels of injury if not avoided. Explains situations that may cause damage to equipment if not avoided.

(1), (2), (3), ...

Indicates consecutive numbers in operating procedures for the order in which successive steps in the procedure should be taken.

Note

Introduction

Convention

Indicates a comment or supplementary information. Indicates a reference.

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Chapter

1.1

1 Precautions

Safety Before using this product, read this section carefully so that you can operate it correctly. Whenever you operate this product, be sure to observe those precautions. Failure to do so may cause you to subject to injuries or property damage to occur.

Chapter 1 Precautions

WARNING • The institution is responsible for the use and maintenance of this product. In addition, this product should not be used by persons other than doctors or suitably trained staff. • Be sure to prepare a spare endoscope against unexpected accidents such as the failure of this product. Otherwise, you may not be able to continue the endoscopic procedure. If the spare endoscope is not available, prepare other alternative means such as abdominal surgery. This product is intended for use by medical professionals who have received proper training in endoscopic procedures. This manual does not provide information about clinical procedures or any aspects of endoscopic techniques.

CAUTION • Do not modify this product or its components, and do not disassemble, repair or in any other way reverse-engineer these products. Even if you find a defect, do not attempt to repair these products yourself. FUJIFILM Corporation shall not be liable for any defects or device failures caused by such modifications, disassembly, repairs or reverse-engineering. If this product is disassembled or modified, it creates a risk of human injury or equipment damage, and is unable to ensure its functionality.

♦ Category of Equipment <Classification of Medical Electrical Equipment> 1. Type of protection against electric shock: Class I equipment (Power supply: Protective earth plug) 2. Degree of protection against electric shock: Type BF applied part 3. Degree of explosion protection : Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide Note Combination with VP-7000

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Chapter 1 Precautions

1.1.1

Warnings This product utilizes a flashing light. Do not expose a flashing light to an epilepsy patient. Doing so may cause the patient to have seizures, difficulty in breathing and suffocation. Stop using this product immediately and take proper action if the patient develops such signs and symptoms.

1.1.2

Direct Harm to Human Body

WARNING • If any peripherals not described in the VP-7000 Operation Manual, “2.2 Equipment Using in Combination” are used, this product may not function properly and it may cause damage to the peripherals or injury to patients or physicians. • This product conforms to the EMC standard (EN 60601-1-2: 2007). However, the radio waves radiated form this product may cause medical devices such as a pacemaker to malfunction. When this product is used for a patient with an active implantable medical device, consult a cardiovascular specialist and the manufacturer of the active implantable medical device. • To avoid damage to eyes, do not look at the light directly while the light is turned on. Do not look directly at the light from the endoscope.

CAUTION • While the light is turned on, do not look into the light emitted from the distal end of endoscope. Doing so may cause damage to the eyes. • Do not touch the light guide prong until it has cooled down (approximately 5 minutes). Touching the light guide prong with hands immediately after use of the endoscope may cause a burn. • When connecting the endoscope, insert it fully so as to produce no clearance. Do not look into the connecting part of the endoscope. The light emitted from the light source may cause damage to the eyes.

CAUTION • If the brightness level is high, the surface temperature at and around the distal end of the endoscope may exceed 41°C. Do not allow the distal end to remain in contact with the same site for an extended period of time. It may cause burn injury.

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1.2

Cautions/Warnings Observe the following cautions when handling this product. Also, there are same cautions in each chapter.

1.2.1

Intended Use

WARNING • This product is intended to be used in combination with a FUJIFILM medical endoscope, processor, monitor, recorder and various peripherals for observation, diagnosis, endoscopic treatment, and image recording in medical facilities under the management of physicians. Never use this product for any other purposes.

1.2.2

Chapter 1 Precautions

• Do not rely on the BLI observation mode alone. Perform comprehensive observation and diagnosis including normal observation for all target regions. Not doing so may result in improper observation and diagnosis. Information obtained from the BLI mode image should be regarded as reference information and it does not assure the validity of diagnosis.

Clinical Procedures

WARNING • This manual assumes that the product will be used by medical specialists who have received proper training in endoscopic procedures. This manual does not provide information about clinical procedures. Proper clinical judgment should be exercised for all clinical procedures.

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Chapter 1 Precautions

1.2.3

Loss of Function

WARNING • During an examination, if the endoscopic image disappears, a live image is not displayed after freeze mode has been cancelled, or the endoscopic image is discolored, reset the processor and light source. • During treatment, if the endoscopic image disappears, a live image is not displayed after freeze mode has been cancelled, or the endoscopic image is discolored, stop treatment immediately, remove the endotherapy device from the endoscope, and then reset the processor and light source. • If an appropriate image does not appear even after resetting the processor and light source, turn them off, straighten the bending section, and then withdraw the endoscope slowly from the patient. • Should the endoscopic image disappear during an examination or treatment, and if the processor and light source are not turned off, it may cause overheating of the distal end of the endoscope, possibly resulting in mucosal burns or other injury. Note

• ‌Reset: Turn off the processor and the light source, and wait for at least 5 seconds. Turn on the processor and the light source again, and then turn on the light by pressing the Light button. • For details on how to operate the endoscope, refer to the operation manual of the endoscope.

1.2.4

Combination of Equipment

WARNING • This product is used in combination with peripherals. To avoid electric shock, do not use peripherals that are not specified in the VP-7000 Operation Manual, “2.2 Equipment Using in Combination”.

1.2.5

Electric Shock

WARNING • Use the rated voltage only. Not doing so may cause a fire or electric shock or malfunction. • Connect the power plug directly to the protective earth receptacle. Use peripherals that are compliant with the medical safety standards. Not doing so may cause an electric shock.

1.2.6

Explosion

WARNING • Do not use the equipment in an oxygen-rich environment or in a flammable gas atmosphere. Doing so may cause explosion or fire.

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1.2.7

Maintenance

CAUTION • The equipment will wear out and deteriorate after repeated use over a long period. The equipment is required to be inspected by specialists once every six months. Also, if any abnormality is found during clinical use, carefully withdraw the endoscope from the patient as per instructions provided in the operation manual of the endoscope. • Do not disassemble or modify the equipment. For details on the inspection, consult your local FUJIFILM dealer.

1.2.8

Preparation and inspection before use

CAUTION

Chapter 1 Precautions

• Prior to using this product, prepare a spare one to avoid unexpected accidents such as equipment failure. If a replacement is not available, you may not be able to continue endoscopic procedures. • Make sure to check the equipment before use according to the procedures provided in this manual, to avoid unexpected accidents, and take full advantage of the equipment’s capabilities. • In particular, errors in images may cause false diagnosis. If the inspection result shows any abnormality, do not use the equipment.

1.2.9

Installation of Equipment

CAUTION • Since there are ventilation holes on the bottom surface of the light source BL-7000, take care not to cover the bottom surface with foreign substances. • Install equipment so that the power cord or connected endoscope cannot be caught by anything. If the power cord or connected endoscope is caught by something, it may cause overturning or falling of equipment, disappearance of the endoscopic image or damage to the patient and/or operator.

1.2.10 Handling CAUTION • Keep metals except for the endoscope away from the power supply section. Otherwise, metals may generate heat. • Do not disassemble or modify this product. Otherwise, the radiant intensity may exceed Class I specifications. • Clean the equipment in the proper way as specified. Otherwise, the equipment may be damaged. • Do not wash the light source with running water or immerse it in disinfectant. The equipment may be damaged. • Do not disinfect or sterilize the light source. The equipment may be damaged. • Wear rubber gloves when handling an endoscope to prevent infection and electrostatic discharge. 1-5

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Chapter 1 Precautions

1.2.11 Foreign Matter and Liquid CAUTION • Before connecting the endoscope, ensure that no foreign matter is caught in the scope connector section. If any foreign matter is caught in the power supply section, it may cause malfunction or failure of the devices and may also generate heat. If any foreign matter is caught, do not touch it directly with your hand but remove it after disconnecting the endoscope. • Ensure that there is no foreign matter or dirt on the receiving window or on the communication window before connecting the endoscope. If there is any foreign matter or dirt on the receiving window or on the communication window, it may cause malfunction or failure of the devices. • Make sure that the scope connector including the power-receiving section is thoroughly dry before connecting it to the light source. In addition, make sure that no moisture or foreign matter (such as metallic fragments, chemical residues, water deposits, grease, dust, and gauze fibers) adheres to the power-receiving section. If the connector mount is wet or soiled with foreign matter, it may cause malfunction or failure of the devices. • Foreign matter, water and chemicals entering the equipment may cause a fire or electric shock. In such a case, stop using the equipment immediately, disconnect the power plug from the power outlet, and consult your local FUJIFILM dealer.

1.2.12 Disposal CAUTION • Follow the legal procedures when discarding the product. For the details, consult your local FUJIFILM dealer.

1.2.13 Software Version • Software is used to control the BL-7000. Therefore, the control method differs depending on the version of the software being used. This instruction manual describes operation of Ver. 1.0 - 1.9. The version is shown under the heading “Software” displayed on the screen by pressing the [Shift] and [Note] keys at the same time.

1.2.14 Temperature at distal end • Turn off the light when this product is not used for a long time, such as while hanging it on a hanger before use. If the light is left on, the distal end may become hot, causing burn injury to the patient.

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1.2.15 Electromagnetic interference • This equipment has been tested and found to comply with the limits for medical devices defined in EN 60601-1-2: 2007. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. However, it is possible that it may cause harmful interference to other devices in the vicinity, if it is installed and used in accordance with the instructions. Also, there is no guarantee that interference will not occur in a particular installation. Therefore, if this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • Change the orientation or position of any affected device. • Increase the spacing between devices. • Consult the manufacturer or dealer of the device.

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Chapter 1 Precautions

Electromagnetic interference may occur on this product in the vicinity of equipment marked with the following symbol or other portable and mobile RF (radio frequency) communications equipment. If interference occurs, mitigation measures may be necessary, such as reorienting or relocating this instrument, or shielding the location. Noise may appear on the monitor of this equipment due to the effect of electromagnetic waves. In this case, turn off the device emitting the electromagnetic waves or move the device away from this equipment. Use the cable specified in the Operation Manual of the processor for this product. Use of other cables may cause an increase in electromagnetic emission or decrease in electromagnetic immunity of this product.

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Chapter 1 Precautions

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Chapter

2.1

and System 2 Components Configuration of BL-7000

Components of BL-7000 The BL-7000 consists of the following items.

♦ BL-7000 Components Note

• The operation manual (this document) is a component of BL-7000. • The figure in parentheses indicates the quantity.

Chapter 2 Components and System Configuration of BL-7000

Light Source BL-7000 (1)

Interface Cable CC7-101 (1)

Louver (1)

Operation Manual BL-7000 (1)

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Power Cord (1)

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Chapter 2 Components and System Configuration of BL-7000

2.2

Standard System Configuration The standard system configuration is the minimum configuration required for general endoscopy. Observation (diagnosis) and biopsy can be performed on the monitor.

Water Tank WT-4 WT-603

Processor VP-7000

Light Source BL-7000

LCD Monitor CL-22 CL-24 CCL220/AR CCL244/AR

Endoscope 700 System Scope 600 System Scope 500 System Scope

Interface Cable CC7-101

Data Keyboard DK-7000U or DK-7000E

Cart

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