XL4450 Light Source Operation Manual Ver 1.0

Important Safety Information

Important Safety Information 1. Intended Use This product is intended to be used in combination with FUJINON 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.

2. Safety Read and understand this manual carefully before using the product according to the instructions given. Items important for the safe use of the system are summarized in “Chapter 1 Safety.” Safety precautions associated with individual operations or procedures are provided separately by “ WARNING” or “ CAUTION.”

3. Warning Items that must be observed in particular for the safety when performing endoscopy and electrosurgery are identified by “ WARNING” and “ CAUTION.” Read and understand the precautions carefully to ensure that procedures are performed correctly.

WARNING Improper use or operation of the equipment may injure patients, physicians, or people in the vicinity. Read and understand this manual carefully before operating the equipment. Improper operations that will damage the equipment only are indicated by “CAUTION.”

4. Installation Only service personnel are allowed to install this system. No one except service personnel should install this system.

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Important Safety Information

5. Combination of Equipment This product is used in combination with peripherals. To avoid electric shock, do not use peripherals that are not specified in the VP-4450HD/XL-4450 Installation Manual, “2.1 Equipment Using in Combination” (page 2-2).

6. About Clinical Procedures 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.

7. Inspection before Use Make sure to check the equipment before use according to “Chapter 4 Method of Use,” to avoid unexpected accidents and take full advantage of the product’s capabilities. If the inspection result shows any abnormality, do not use the equipment.

8. High Voltage This product has high voltage portions. No one except service personnel should touch the inside.

9. Foreign Matter and Liquid 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 dealer.

10. Maintenance The equipment will wear out and deteriorate after repeated use over a long period. Have it checked by specialists once every six months or when the cumulative time of lamp use reaches 300 hours. Also, have it checked if any problem is found in the equipment. Do not disassemble or modify the equipment. For details on the inspection, consult your local dealer.

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Important Safety Information

11. Loss of Function If an image disappears during examination, reset [Note] the processor and the light source. If the image is not recovered, turn the processor and the light source off, and then straighten the bending portion to unlock and release the angle knob. Move your hand away from the knob and pull out the Endoscope slowly. If a live image is not displayed after the freeze mode is cancelled during examination, reset [Note] the processor and the light source. If the image is not recovered, turn the processor and the light source off, and then straighten the bending portion to unlock and release the angle knob. Move your hand away from the knob and pull out the Endoscope slowly. If an image is suddenly discolored during examination, reset [Note] the processor and the light source. If the image is not recovered, turn the processor and the light source off, and then straighten the bending portion to unlock and release the angle knob. Move your hand away from the knob and pull out the Endoscope slowly. [Note] Reset: Turn the power to the processor and the light source, and after more than five minutes, turn them on again, and then, light the lamp by pressing the Lamp button.

12. About the Emergency Lamp Do not perform observation or operation under the emergency lamp. The emergency lamp cannot be used in the following conditions. •• When a safety device is activated due to overheating of the main lamp •• When a safety device is activated because the air-cooling fan for the main lamp and the fan cooling the inside of the lighting device stop •• When the lighting device is faulty •• When the emergency lamp has burnt out

13. If Any Abnormality Occurs During the Clinical Procedure If any abnormality occurs with the equipment during the clinical procedure, refer to “Chapter 6 Troubleshooting”.

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Important Safety Information

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Contents

Contents Important Safety Information...2 Preface...8 Conventions Used in This Manual...8

6

Chapter 1

Safety... 1-1

Chapter 2

Components and System Configuration of XL-4450... 2-1 2.1 Components of XL-4450... 2-2 2.2 Standard System Configuration... 2-3 2.3 Extended System Configuration... 2-4

Chapter 3

Name and Function of Each Part... 3-1 3.1 Front Panel... 3-2 3.2 Rear Panel... 3-4 3.3 Left Side Panel... 3-5 3.4 Right Side Panel... 3-6 3.5 Bottom... 3-7 3.6 Indication Marks... 3-7 3.7 Water Tank... 3-8

Chapter 4

Method of Use... 4-1 4.1 Installation and Connection of the Equipment and Peripherals.. 4-2 4.2 Preparation and Inspection of the System... 4-2 4.3 Lighting the Lamp ... 4-2 4.4 Adjusting the Brightness... 4-4 4.5 Operation of Air Supply Pump... 4-5 4.6 Transmitted Illumination... 4-6 4.7 Light Limit... 4-7

Chapter 5

Storage and Maintenance... 5-1 5.1 Care after Use... 5-2 5.2 Storage... 5-3 5.3 Relocation... 5-4 5.4 Testing the Emergency Lamp... 5-5 5.5 When the Emergency Lamp Alarm Flashes... 5-5 5.6 Duration for the Replacement of Lamp... 5-7 5.7 Replacement of Main Lamp (Xenon)... 5-8 5.8 Replacement of Emergency Lamp (Halogen)... 5-10 5.9 Washing the Water Tank... 5-11 5.10 Disinfection of Water Tank... 5-14 5.11 Sterilization of Water Tank... 5-16

Contents

Chapter 6

Troubleshooting... 6-1 6.1 Troubleshooting... 6-2 6.2 Error messages... 6-6

Appendix...Appendix-1 Main Specification...Appendix-2 Disposal of Electric and Electronic Equipment...Appendix-5 Warranty and After-Sales Service...Appendix-6 Index...Appendix-7

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Preface

Preface This manual describes how to use and store the Light Source XL-4450. XL-4450 is used with the processor VP-4450HD. For details on how to use this system and combined equipment, refer to the DK-4450 or DK-4450E operation manual and the VP-4450HD/XL-4450 installation manual.

Conventions Used in This Manual This manual uses the following conventions to make it easy to understand operations. General Conventions Convention

Meaning Indicates a potential danger that may cause harm to people.

WARNING

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

CAUTION

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

CAUTION

Explains situations that may cause damage to equipment if not avoided.

(1), (2), (3), ... [Note]

Consecutive numbers in operating procedures indicate the order in which successive steps in the procedure should be taken. Indicates a comment or supplementary information. Indicates a reference.

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Chapter 1

Safety

This chapter summarizes the information necessary for safe use of this system.

1-1

Chapter 1 Safety

Chapter 1 Safety 1. Precautions for Use 1) Inspection before use 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. 2) Combination of equipment This product is used in combination with peripherals. To avoid electric shock, do not use peripherals that are not specified in the VP-4450HD/XL-4450 Installation Manual, “2.1 Equipment Using in Combination” (page 2-2). 3) Maintenance The equipment will wear out and deteriorate after repeated use over a long period. Have it checked by specialists once every six months or when the cumulative time of lamp use reaches 300 hours. Also, have it checked if any problem is found in the equipment. Do not disassemble or modify the equipment. For details on the inspection, consult your local dealer. 4) Temperature at distal end When the Endoscope projects light at high brightness over an extended time, the temperature may exceed 41°C at the distal end. When you hang the Endoscope on the cart hanger, turn the lamp off. 5) Electromagnetic interference This equipment has been tested and found to comply with the limits for medical devices defined in EN 60601-1-2:2001. 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:

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Chapter 1 Safety

•• Change the orientation or position of any affected device. •• Increase the spacing between devices. •• Consult the manufacturer or dealer of the device. 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. 6) Handling of Endoscope Wear rubber gloves when handling an Endoscope to prevent infection and electrostatic discharge. 7) To avoid malfunction due to lightning Connect the equipment to the power source suitable for the structures and facilities of the hospital or clinic.

2. Disposal This product has components that contain cadmium. Cadmium is harmful to humans and the environment. When disposing of the equipment, follow the procedures that comply with the local regulations. For details, consult your local dealer.

3. “ WARNING” and “ CAUTION” Messages Appearing in Individual Chapters Chapter 4 Method of Use 4.1 Installation and Connection of the Equipment and Peripherals It may cause a fire or electric shock. Use the rated voltage only. It may cause an electric shock. Connect the power plug to the protective earth receptacle. Use peripherals that are compliant with the medical safety standards. It may cause explosion or fire ignition. Do not use the equipment in a flammable gas atmosphere. Touching the LG connector with hands immediately after use of the Endoscope may cause a burn. Do not touch the LG connector tip until it has cooled down (5 minutes).

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Chapter 1 Safety

4.3 Lighting the Lamp To avoid damage to eyes, do not look at the lamp directly while the lamp is turned on. Do not look directly at the light from the Endoscope. Chapter 5 Storage and Maintenance 5.2.2 Storage of Water Tank It may cause infection. Dry the water tank before storing it. 5.7 Replacement of Main Lamp (Xenon) It may cause electric shock. To replace the lamp, first remove the power plug from the receptacle. Touching the lamp immediately after it is used may cause a burn. Do not touch the lamp by hand until it has cooled down (60 minutes). 5.9 Washing the Water Tank To disinfect and sterilize the water tank sufficiently, wash it immediately after use. 5.10 Disinfection of Water Tank Vapor of the disinfectant may adversely affect a human body. Provide adequate ventilation during the disinfection. Close the cover of the immersion tub when immersing the tank into the disinfectant.

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Chapter 2

Components and System Configuration of XL-4450

This chapter describes the components and system configuration of the XL-4450 set.

2.1 Components of XL-4450...2-2 2.2 Standard System Configuration...2-3 2.3 Extended System Configuration...2-4

2-1

Chapter 2 Components and System Configuration of XL-4450

Chapter 2 Components and System Configuration of XL-4450 2222 Components of XL-4450 The XL-4450 consists of the following items. [Note] The figure in parentheses indicates the quantity.

Light Source XL-4450 (1)

Operation Manual (1)

2-2

Chapter 2 Components and System Configuration of XL-4450

2222 Standard System Configuration The standard system configuration is the minimum configuration required for general endoscopy. This system allows you to perform observation (diagnosis) and biopsy via the monitor.

Water Tank WT-2

Light Source XL-4450

Processor VP-4450HD

LCD Monitor CDL1909A CDL1576A RADIANCE24 (NDS)

Endoscope The 500 system scope The 400 system scope

Interface Cable CC1-9R3 (provided with VP-4450HD)

Data Keyboard DK-4450E

Cart

2-3

Chapter 2 Components and System Configuration of XL-4450

2222 Extended System Configuration This system can be extended by connecting various peripherals to the standard system configuration. Extension makes the following possible. •• Endoscopic treatment •• Ultrasonography •• Recording of video images •• Printing of still images •• Recording of still images

Ultrasonic Observation Unit SU-7000

Sonoprobe System

Water Tank WT-2

Endoscope The 500 system scope The 400 system scope

Light Source XL-4450

Processor VP-4450HD

Data Keyboard DK-4450E Cart

2-4

Chapter 2 Components and System Configuration of XL-4450

[Note] For details on the connections of peripherals other than listed here, consult your local dealer.

Electrosurgical Unit ICC 200 (ERBE)

LCD monitor CDL1909A CDL1576A RADIANCE24 (NDS)

Printer UP-55MD (SONY) UP-21MD (SONY) CP900UM (120V) (MITSUBISHI) CP900E (230V) (MITSUBISHI) CP900DW (MITSUBISHI)

DVD Recorder LQ-MD800 (Panasonic) DVO-1000MD (SONY)

2-5

Chapter 2 Components and System Configuration of XL-4450

2-6

Chapter 3

Name and Function of Each Part

This chapter describes the names and functions of the XL-4450.

3.1 3.2 3.3 3.4 3.5 3.6 3.7

Front Panel...3-2 Rear Panel...3-4 Left Side Panel...3-5 Right Side Panel...3-6 Bottom...3-7 Indication Marks...3-7 Water Tank...3-8

3-1

Chapter 3 Name and Function of Each Part

Chapter 3 Name and Function of Each Part 3333 Front Panel

1

2

3

4

5

6

7

POWER

LIGHT SOURCE XL-4450

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11

10

1 Scope Socket

Accepts the LG connector of the Endoscope.

2 Air Supply Lamp

Displays the air supply pump lever of “HI” “MID” or “LOW”. L M H

Air supply [HI] : Air supply [MID]: Air supply [LOW]: Air supply [OFF]:

3-2

L M H L M H L M H L M H

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