FujiFilm BL-7000 User manual

897N120551D
Light Source
OPERATION MANUAL
English
Introduction
Precautions
1
Components and System
Con guration of BL-7000
2
Name and Function of Each
Part
3
Installation and Connection of
the Equipment and Peripherals
4
Preparation and Inspection of
the System
5
Method of Use
6
Storage and Maintenance
7
Troubleshooting
8
Main Speci cation
9
BL-7000
Thank you for purchasing our product. Read this
manual carefully before use to avoid unexpected
accidents and to take full advantage of the
product's capabilities.
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ii 897N120551D
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iii
897N120551D
Contents at a Glance
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 Conguration of BL-7000
This chapter describes the composition of the endoscope set of accessories and
system configuration.
Chapter 3 Name and Function of Each Part
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 Specication
This chapter describes the main specification of this product.
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iv 897N120551D
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 Precautions 1-1
1.1 Safety .....................................................................................................................1-1
♦ Category of Equipment .........................................................................1-1
1.1.1 Warnings ..................................................................................................1-2
1.1.2 Direct Harm to Human Body .....................................................................1-2
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 Components and System Conguration of BL-7000 2-1
2.1 Components of BL-7000 ........................................................................................2-1
♦ BL-7000 Components ..........................................................................2-1
2.2 Standard System Conguration .............................................................................2-2
2.3 System Expansion .................................................................................................2-4
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897N120551D
Contents
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
Chapter 5 Preparation and Inspection of the System 5-1
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 Operation Check of Light Source .............................................................5-4
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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Contents
Chapter 8 Troubleshooting 8-1
8.1 Troubleshooting .....................................................................................................8-1
8.2 Error Messages .....................................................................................................8-5
Chapter 9 Main Specication 9-1
9.1 Specication ..........................................................................................................9-1
♦ Classication of Medical Electrical Equipment .....................................9-1
♦ Applied Part ..........................................................................................9-1
♦ Specication .........................................................................................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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897N120551D 1
Introduction
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.
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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897N120551D
2
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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897N120551D 3
Introduction
How to Read This Manual
♦
Conventions Used in This Manual
This manual uses the following conventions for easier understanding.
General Conventions
Convention 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
Indicates a comment or supplementary information.
Indicates a reference.
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897N120551D
4
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897N120551D 1-1
Chapter 1 Precautions
Chapter 1Precautions
1.1 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.
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 nd 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 modications, disassembly, repairs or reverse-engineering.
If this product is disassembled or modied, it creates a risk of human injury or equipment
damage, and is unable to ensure its functionality.
♦ Category of Equipment
<Classication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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897N120551D
1-2
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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897N120551D 1-3
Chapter 1 Precautions
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.
• 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.
1.2.2 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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897N120551D
1-4
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 specied 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 re 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 ammable gas atmosphere.
Doing so may cause explosion or re.
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897N120551D 1-5
Chapter 1 Precautions
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
• 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 specications.
• Clean the equipment in the proper way as specied. 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.
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897N120551D
1-6
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 bers) 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 re 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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897N120551D 1-7
Chapter 1 Precautions
1.2.15 Electromagneticinterference
• This equipment has been tested and found to comply with the limits for medical devices
dened 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.
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 specied 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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897N120551D
1-8
Chapter 1 Precautions
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897N120551D 2-1
Chapter 2 Components and System Conguration of BL-7000
Chapter 2
Components and System
Conguration of BL-7000
2.1 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 gure in parentheses indicates the quantity.
Light Source
BL-7000 (1)
Power Cord (1)
Operation Manual
BL-7000 (1)
Interface Cable
CC7-101 (1)
Louver (1)
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897N120551D
2-2
Chapter 2 Components and System Conguration of BL-7000
2.2 StandardSystemConguration
The standard system configuration is the minimum configuration required for general
endoscopy. Observation (diagnosis) and biopsy can be performed on the monitor.
Endoscope
700 System Scope
600 System Scope
500 System Scope
Data Keyboard
DK-7000U or DK-7000E
Light Source
BL-7000
Processor
VP-7000
Cart
Water Tank
WT-4
WT-603
LCD Monitor
CL-22
CL-24
CCL220/AR
CCL244/AR
Interface Cable
CC7-101
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