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Light Source
OPERATION MANUAL
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.
897N120551D
English
Introduction
1
Precautions
Components and System
2
Confi guration of BL-7000
Name and Function of Each
3
Part
Installation and Connection of
4
the Equipment and Peripherals
Preparation and Inspection of
5
the System
6
Method of Use
7
Storage and Maintenance
8
Troubleshooting
9
Main Specifi cation
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Summary of Contents for FujiFilm BL-7000
- Page 1 English Light Source Introduction Precautions OPERATION MANUAL Components and System Confi guration of BL-7000 Name and Function of Each Part Installation and Connection of the Equipment and Peripherals Preparation and Inspection of the System Method of Use Storage and Maintenance...
- Page 2 897N120551D...
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Page 3: Contents At A Glance
1 Precautions Chapter This chapter describes the warnings and cautions for safe operation of this product. 2 Components and System Configuration of BL-7000 Chapter This chapter describes the composition of the endoscope set of accessories and system configuration. 3 Name and Function of Each Part Chapter This chapter describes the name and function of each part of this product. -
Page 4: Table Of Contents
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 Configuration of BL-7000 Components of BL-7000 ..................2-1 ♦ BL-7000 Components ................2-1 Standard System Configuration ................2-2 System Expansion ....................2-4... - Page 5 Chapter 3 Name and Function of Each Part Front Panel ......................3-1 Rear Panel ......................3-3 Left Side Panel ......................3-4 Bottom ........................3-5 Warning Labels ......................3-6 ♦ Caution Label ..................3-6 Rating Plate ......................3-6 Symbols .........................3-7 Chapter 4 Installation and Connection of the Equipment and Peripherals 4-1 Attaching the Louver ....................4-1 Chapter 5 Preparation and Inspection of the System...
- Page 6 Contents Chapter 8 Troubleshooting Troubleshooting .....................8-1 Error Messages .....................8-5 Chapter 9 Main Specification 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 ♦...
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Page 7: 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. - Page 8 • 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.
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Page 9: How To Read This Manual
How to Read This Manual Conventions Used in This Manual ♦ This manual uses the following conventions for easier understanding. General Conventions Convention Description Explains dangerous situations that may cause death or serious WARNING injury if not avoided. Explains situations that may cause slight or moderate levels of injury if not avoided. - Page 10 897N120551D...
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Page 11: Chapter 1 Precautions
• 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. -
Page 12: Warnings
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. -
Page 13: Cautions/Warnings
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. -
Page 14: Loss Of Function
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. -
Page 15: Maintenance
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. -
Page 16: Foreign Matter And Liquid
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. -
Page 17: Electromagnetic Interference
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. - Page 18 Chapter 1 Precautions 897N120551D...
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Page 19: Components And System Configuration Of Bl-7000
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. Light Source BL-7000 (1) Interface Cable... -
Page 20: Standard System Configuration
Chapter 2 Components and System Configuration of BL-7000 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 LCD Monitor CL-22... - Page 21 897N120551D...
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Page 22: System Expansion
Chapter 2 Components and System Configuration of BL-7000 System Expansion This system can be extended by connecting various peripherals to the standard system configuration. Extension makes the following possible. • Endoscopic treatment • Ultrasonic examination • Recording of video images • Printing of still images... - Page 23 For details on the connections of peripherals other than listed here, consult your local FUJIFILM dealer. * When the 590 series scope is used, place the VP-7000 processor on the lower shelf and the BL-7000 light source on the upper shelf. VP-7000 Operation Manual, “4.1.6 Installation for System Expansion” Electrosurgical Unit...
- Page 24 Chapter 2 Components and System Configuration of BL-7000 897N120551D...
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Page 25: Chapter 3 Name And Function Of Each Part
Chapter Name and Function of Each Part Front Panel 1. Scope Connector Socket Accepts the scope connector or LG connector of the endoscope. 2. Air Supply Indicator Displays the air supply pump’s level of “HI”, “MID” or “LOW”. 3. Pump Button Switches the air supply amount in the four levels of “HI”, “MID”, “LOW”... - Page 26 Chapter 3 Name and Function of Each Part 6. Power Indicator Lamp Lights up when the power is ON. 7. Power Button Used to turn the power supply ON/OFF. 8. Light Source Status Lamp If any abnormality occurs in the light source, this indicator flashes. 9.
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Page 27: Rear Panel
Rear Panel 1. Interface Cable Connector (Processor) Used to connect to the VP-7000 using the interface cable (CC7-101). 2. Potential Equalization Terminal Connects to the equalization plug. When necessary for safety, this product is connected to a peripheral using this terminal to equalize the potential between the devices. -
Page 28: Left Side Panel
Chapter 3 Name and Function of Each Part Left Side Panel 1. Water Tank Hook Used to mount the water tank. 897N120551D... -
Page 29: Bottom
Bottom 1. Louver The filers are set. 2. Filter Prevents intrusion of dust. 3. Ventilation Holes Provide ventilation to keep the inside of the equipment cool. 897N120551D... -
Page 30: Warning Labels
Chapter 3 Name and Function of Each Part Warning Labels ♦ Caution Label Caution Label Rating Plate Rating Plate 897N120551D... -
Page 31: Symbols
Symbols Symbol Description Serial number Year of manufacture Manufacturer Authorised representative in the European Community Front Panel : Light Source Status Lamp (Consult instructions for use) Rear Panel : Consult instructions for use Consult instructions for use Temperature limitation Keep dry CE marking Type BF applied part WEEE marking *... - Page 32 Chapter 3 Name and Function of Each Part 897N120551D...
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Page 33: Installation And Connection Of The Equipment And Peripherals
Doing so may cause explosion or fire. 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. - Page 34 Chapter 4 Installation and Connection of the Equipment and Peripherals 897N120551D...
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Page 35: Chapter 5 Preparation And Inspection Of The System
Chapter Preparation and Inspection of the System Installing and Connecting the Equipment Prepare and inspect the system according to the VP-7000 Operation Manual, “Chapter 6 Preparation and Inspection of the System”. WARNING • If any peripherals not described in the VP-7000 Operation Manual, “2.2 Equipment Using in Combination”... -
Page 36: 700 System Scope
Chapter 5 Preparation and Inspection of the System Note • To avoid damage or malfunction, turn OFF the processor, and then connect or remove the endoscope. Wait for 5 seconds or more before turning the power back to ON. Do not touch the electrical contacts directly with your hand. Prevent the contacts from exposure to xylocaine spray, etc. - Page 37 Remove the socket protection cap from the processor to be connected to the endoscope. To connect the electrical connector, align it with the electrical connector index, and then rotate the connector clockwise while lightly pressing it. Note • Make sure to rotate the connector index 90 degrees clockwise. •...
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Page 38: Operation Check Of Light Source
Chapter 5 Preparation and Inspection of the System 5.1.2 Operation Check of Light Source CAUTION • 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. •... - Page 39 Press the Pump button to set the air supply pump’s operation to “HI.” Leave the distal end of the endoscope in the air, press the air/water valve, and make sure that water comes out of the air/water nozzle. Note Be careful of the direction when water comes out. Immerse the distal end of the endoscope in the water, cover the center hole on the air/ water valve with a finger, and make sure that air comes out of the air/water nozzle.
- Page 40 Chapter 5 Preparation and Inspection of the System Apply your palm against the distal end of the endoscope, and make sure that the indicator level of the light source changes when you move your hand toward and away from the distal end. Apply the palm of the hand to the distal end of endoscope and make sure that the image of a part of the hand can be seen.
- Page 41 When two points of light are seen, the system is operating normally. If only one point of light or no light is seen, stop using the equipment immediately, turn off the equipment and consult your local FUJIFILM dealer. Note If the light emitted from the distal end of endoscope is viewed directly, it may cause damage to the eyes.
- Page 42 Chapter 5 Preparation and Inspection of the System 897N120551D...
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Page 43: Chapter 6 Method Of Use
Chapter Method of Use Introduction The operation flow of this product is shown below. For details on each operation, refer to the relevant section. Perform inspections before use. “Chapter 5 Preparation and Inspection of the System” Connect the endoscope. “5.1.1 Installing the Endoscope and Water Tank”... -
Page 44: Turning On The Light
Chapter 6 Method of Use When necessary, perform maintenance “7.1 Care after Use” on this product after all examinations are “7.2 Cleaning the Filter” finished. * This step may be skipped depending on the examination method. Turning On the Light CAUTION •... - Page 45 Press the Light button. The Light button lights up in blue, the lamp at the left-hand side of the Light button lights up, and the light turns on. The pictogram for brightness level lights up in blue. Note • The light does not turns on when the scope connector or LG connector of the endoscope is not connected to the scope socket.
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Page 46: Adjusting The Brightness
Chapter 6 Method of Use Adjusting the Brightness 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. -
Page 47: Operation Of Air Supply Pump
Operation of Air Supply Pump Turn the power of the light source ON. The air supply level changes in order of “HI”, “MID”, “LOW” and “OFF” by pressing the Pump button. Select “HI,” “MID” or “LOW.” Press the air/water valve of the endoscope to discharge water from the nozzle. Note Be careful of the direction when water comes out. -
Page 48: Transmitted Illumination
Chapter 6 Method of Use Transmitted Illumination The transmitted illumination is used to check the position of the distal end from outside the body. The light flashes with the maximum light intensity. Press the Transmitted Illumination button. The lamp above the button flashes. The light flashes with the maximum amount of the light. -
Page 49: Light Save
Light Save To avoid the blood of a bleeding patient becoming clotted by the illuminating light, the light save function is used to limit the maximum light intensity of the light. Note Blood may become clotted in some cases even if the light save function is used. Press the Light Save button. -
Page 50: Light Mode
Chapter 6 Method of Use Light Mode The Light Mode can be switched to "1", "2" or "OFF". Press the Light Mode button. The Light Mode changes in the order of “1” ( ), “2” ) and “OFF” ( ) each time the Light Mode button is pressed. Turning Off the Light Press the Light button. -
Page 51: Turning Off The Power
Turning Off the Power CAUTION • 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. Press and hold the EXAM. Button on the front panel of the processor for 2 seconds or more. - Page 52 Chapter 6 Method of Use 6-10 897N120551D...
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Page 53: Chapter 7 Storage And Maintenance
Do not clean the inner side of the scope connector socket or the receiving window. If it becomes dusty or dirty, consult your local FUJIFILM dealer. For details on the cleaning, maintenance and disinfection of the endoscope, refer to the operation manual of the endoscope. -
Page 54: Cleaning The Filter
Chapter 7 Storage and Maintenance Cleaning the Filter Remove the louver from the light source. Remove dust from the filters of the louver. Filters Louver Attach the louver to the light source. Make sure that the louver is fully inserted into the light source. Not doing so may cause equipment damage. -
Page 55: Storage
Do not store the equipment in a place which does not meet the storage conditions. Store the equipment in a state where no force is applied to the cables. The equipment may be damaged. Store the BL-7000 system in a place that meets the following conditions. <Storage Environment> Note <Operating Environment>... -
Page 56: Relocation
Chapter 7 Storage and Maintenance Relocation Note Do not apply strong impact on the scope connector or LG connector of the endoscope by hitting it against other objects, etc. Install the light source so that no strong impact is applied to the endoscope connected to the light source. When operating an electric bed, etc., avoid hitting it against the scope connector or LG connector of the endoscope connected to the light source. - Page 57 Move the cart carefully not to give any vibration or impacts to the equipment, paying close attention to bumps and slopes. Note • Use two persons to move the cart. • Pay close attention to prevent the monitor and the scope hanger from hitting anything.
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Page 58: When The Light Source Status Lamp Flashes
Chapter 7 Storage and Maintenance When the Light Source Status Lamp Flashes <When the Light Source Status Lamp flashes during the clinical procedure> When the alarm flashes during the clinical procedure, operate the endoscope by following the instruction on the screen, and pull out the endoscope immediately. After the clinical procedure, check the light source according to the following procedure in “<When the Light Source Status Lamp flashes when it is on>”. - Page 59 Turn off the power of the processor and light source. After 5 to 10 seconds, turn the power on. Press the Light button to turn on the light. If the light turns on, the equipment is ready to operate. If not, follow the procedure in (3). Turn off the power of the light source and processor, and turn on the power again.
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Page 60: Cleaning And Disinfecting (Or Sterilizing) The Water Tank
Chapter 7 Storage and Maintenance Cool it down for 2 to 3 minutes, and press the Light button. If the light turns on, the equipment is ready to operate. Cleaning and Disinfecting (or Sterilizing) the Water Tank For details on how to clean and disinfect (or sterilize) the water tank, refer to the operation manual of the water tank. -
Page 61: Chapter 8 Troubleshooting
3) The receptacle is defective. 3) Check that the rated voltage is applied. Lamp does not light up.) 4) The fuse is blown. 4) Consult your local FUJIFILM dealer. The light does not turn 1) The endoscope is not 1) Securely lock the endoscope. - Page 62 Stop using the equipment, and consult your local FUJIFILM dealer. Note • Reset: Turn off the processor and the light source, and wait for at least 5 seconds.
- Page 63 5) The internal part of the light straighten the bending section and then source is faulty. pull out the endoscope slowly. Stop using the equipment, and consult your local FUJIFILM dealer. Distorted image 1) High-frequency 1) Stop power supply to the high-frequency interference.
- Page 64 If air and water are not discharged smoothly, stop using the equipment and consult your local FUJIFILM dealer. Air and water cannot be 1) The air supply pump is 1) Press the Pump button to set the air supplied.
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Page 65: Error Messages
Error message Possible cause Countermeasure Check cable connection between 1) The light source is OFF. 1) Turn on the BL-7000. light source and processor and 2) The processor is not 2) Securely connect the turn off and on light source and connected to the light interface cable. - Page 66 Chapter 8 Troubleshooting 897N120551D...
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Page 67: Main Specification
Chapter Main Specification Specification ♦ 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: Use is prohibited in an oxygen-rich environment or in a flammable gas atmosphere. -
Page 68: Operating Environment
Chapter 9 Main Specification ♦ Operating Environment Operating conditions Temperature +10 to +40°C Humidity 30 to 85%RH (no dew condensation) Pressure 70 to 106 kPa Non-operating conditions Temperature -10 to +45°C Humidity 30 to 95%RH (no dew condensation) Pressure 70 to 106 kPa ♦ Transport and Storage Environment Temperature -20 to +60°C... -
Page 69: Medical Device Directive
♦ Medical Device Directive This product complies with the requirements of European Directive 93/42/EEC. Classification : Class II a 897N120551D... -
Page 70: Electromagnetic Compatibility (Emc) Information
Chapter 9 Main Specification Electromagnetic Compatibility (EMC) Information This product complies with Class B of EN 55011 concerning radio-frequency emissions in the combination of the 700 system scope. In addition, in the combination of other endoscopes, this product complies with Class A. If this product is used in domestic establishments with the Class A combination, electromagnetic interference may occur in any devices. - Page 71 <Electromagnetic Immunity Compliance Information and Guidance> EN 60601-1-2 Compliance Immunity test Guidance Test level level Floors should be wood, Contact: Electrostatic discharge concrete, or ceramic tile. If ±2, ±4, ±6kV Same as (ESD) floors are covered with synthetic Air: left EN 61000-4-2 material, the relative humidity ±2, ±4, ±8kV should be at least 30%.
- Page 72 Chapter 9 Main Specification <Portable and Mobile RF Communications Equipment Compliance Information and Guidance> EN 60601-1-2 Compliance Immunity test Guidance Test level level Portable and mobile RF communications equipment should be used no closer to any part of this product, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
- Page 73 <Recommended Separation Distance Between Portable and Mobile RF Communications Equipment and this Product> The customer or the user of this product can prevent electromagnetic interference by maintaining the minimum distance between this product and cell phone or RF communication equipment (table below). Referring to the table below, keep cell phone or RF communication equipment away from this product. Separation distance related to frequency of the transmitter (m) Rated maximum output power of transmitter P...
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Page 74: After-Sales Service
1) If the equipment does not work properly, check it first by reading this manual again and follow all instructions. 2) If the equipment is still not working well, contact your local FUJIFILM dealer. 3) Repairs during the warranty period We will repair your equipment free of charge according to the provisions of the warranty. -
Page 75: Disposal Of Electric And Electronic Equipment
The recycling of materials will help to conserve natural resources. For more detailed information about recycling of this product, contact your local FUJIFILM dealer. In Countries outside the EU: If you wish to discard this product, contact your local authorities and ask for the correct way of disposal. -
Page 76: Index
Chapter 9 Main Specification Index Air Supply Indicator ......... 3-1 Receiving Window .......... 3-2 alarm ............... 7-6 Safety ............. 1-1 Brightness Adjustment button ....3-2, 6-4 Scope Connector Socket ........ 3-1 Standard System Configuration ..... 2-2 Storage Environment ........7-3 Clinical Procedures ......... -
Page 77: Service Centers
Contact our regional representative below or the distributor from which you purchased the product. <Europe> FUJIFILM Europe GmbH http://www.fujifilm.eu/eu/ See our website to locate our representative in your country. <USA> Fujifilm Medical Systems U.S.A., Inc http://www.fujifilmendoscopy.com/ (800) 385-4666 <Australia> FUJIFILM Australia Pty Ltd. http://www.fujifilm.com.au/ 1800 060 209 <Asia>... - Page 78 FUJIFILM Corporation 26-30, Nishiazabu 2-chome, Minato-ku, Tokyo 106-8620, Japan FUJIFILM Europe GmbH Heesenstrasse 31, 40549 Duesseldorf, Germany EU Importer: FUJIFILM Europe B.V. Oudenstaart 1, 5047 TK Tilburg, The Netherlands 897N120551D 160905 - 5.0 - DT - E2 Printed in Japan...
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