XL4400 EVE Light Source Operation Manual July 2011 DT-E2

Important Safety Information

Important Safety Information For the USA Market - CAUTION: Federal law restricts this device to sale by or on the order of a physician.

1. Intended Use This product is intended to be used in combination with FUJINON/FUJIFILM medical Endoscope, processor, monitor, recorder and various peripherals for observation, diagnosis, endoscopic treatment, taking photographs and recording under the management of physicians. Never use this product for any other purposes.

2. Safety Read and understand this manual carefully before use. Use the product by following the provided instructions. Items important for the safe use of the product are summarized in “Chapter 1 Safety.” Safety precautions associated with individual operations or procedures are provided separately, indicated by “

WARNING” and “

CAUTION.”

3. Warning Items that must be observed in particular for the safety when performing endoscopy and electrosurgy are identified by “

WARNING” and “

CAUTION.” Perform procedures

correctly by reading and understanding the warning information carefully.

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 this system.

Improper operations that will damage the equipment only are identified by “CAUTION.”

2

Important Safety Information

4. Installation The structure of this system allows only service personnel to install it. Have the installation operation performed by the service personnel.

5. Combination of Equipment The Endoscope may be used in combination with peripherals. To avoid an electric shock accident, use only the peripherals that are described in this operation manual.

6. About Clinical Procedures This manual assumes that the product will be used by medical specialists who have received proper training in endoscopic procedures. It does not provide information about clinical procedures. Regarding clinical procedures, use proper clinical judgment.

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 checking results show that there is anything wrong with the equipment, do not use the same equipment.

8. High Voltage The equipment contains high-voltage parts. Do not touch the inside parts except for the specialists.

3

Important Safety Information

9. Foreign Matters and Liquid Foreign matters, water and chemicals entering the equipment may cause a fire or electric shock. If liquid has entered the equipment, stop the use of the equipment immediately, disconnect the power plug from the receptacle and contact your local dealer or FUJINON/ FUJIFILM representative.

10. Maintenance The equipment will wear out and degrade after repeated use for a long period. Have it checked by specialists once every six months or once every 300 hours of cumulative powered-on service time. Also have it checked if there is anything wrong with the equipment. Do not disassemble or modify the equipment.

11. Loss of Function During examination, if an endoscopic image disappears, a live image is not displayed after freeze mode is cancelled, or an endoscopic image is suddenly discolored, reset the processor and light source. If the image is not recovered, turn the processor and light source off, straighten the bending portion and then pull out the endoscope slowly. When an endoscopic image disappears during examination, if the processor and light source are not turned off, it may cause overheating of the distal end of endoscope, resulting in burns or other injury. During treatment, if an endoscopic image disappears, a live image is not displayed after freeze mode is cancelled, or an endoscopic image is suddenly discolored, stop treatment immediately, pull out the treatment tool slowly from the endoscope and then reset the processor and light source. If the image is not recovered, turn the processor and light source off, straighten the bending portion and then pull out the endoscope slowly. When an endoscopic image disappears during treatment, if the processor and light source are not turned off, it may cause overheating of the distal end of endoscope, resulting in 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, light the lamp by pressing the Lamp button. [Note] For details on how to operate the endoscope, refer to the operation manual of the endoscope.

4

Important Safety Information

12. Emergency lamp Do not observe or give treatment with the emergency lamp. The emergency lamp cannot be used under the following conditions: When the safety device has been activated due to overheating of the main lamp When the safety device has been activated because the main lamp cooling fan and the lighting device internal cooling fan are stopped When the lighting device is broken When the emergency lamp has gone off

13. If any abnormality occurs during the clinical procedure If any abnormality occurs with the equipment, refer to “Chapter 6 Troubleshooting.”

5

Important Safety Information Contents

Contents Important Safety Information... 2 Preface ... 8 Conventions Used in This Manual ... 8 Chapter 1

Safety ... 1-1

Chapter 2

Composition of XL-4400 and System Configuration ... 2-1 2.1 Composition of XL-4400 ... 2-2 2.2 Standard System Configuration... 2-3 2.3 Extended System Configuration ... 2-4

Chapter 3

Names and Functions of Parts ... 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 Connecting the Equipment and Materials ... 4-2 4.2 Preparing and Checking of EPX-4400 System ... 4-2 4.3 Lighting the Lamp ... 4-2 4.4 Adjusting the Brightness ... 4-4 4.5 Operating the Air Supply Pump ... 4-5 4.6 Transmitted Illumination... 4-6 4.7 Light Save ... 4-7

6

Important Safety Information Contents

Chapter 5

Storage and Maintenance ... 5-1 5.1 Care after Use ... 5-2 5.2 Storage ... 5-3 5.3 Testing the Emergency Lamp ... 5-4 5.4 When the Emergency Lamp Alarm Flushes ... 5-4 5.5 Duration for the Replacement of Lamp ... 5-6 5.6 Replacement of Main Lamp ... 5-7 5.7 Replacement of Emergency Lamp ... 5-10 5.8 Cleaning of Water Tank ... 5-11 5.9 Disinfection of Water Tank ... 5-14 5.10 Sterilization of Water Tank ... 5-16

Chapter 6

Troubleshooting ... 6-1 6.1 Troubleshooting ... 6-2 6.2 Error Message ... 6-5

Appendix

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

7

Important Safety Information Prefaceface

Preface This manual describes how to use the Light Source “XL-4400.” The XL-4400 is used in combination with the processor “VP-4400.” For information on how to use the EPX-4400 System and the combination, refer to the operation manuals of “VP-4400.”

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 harm to people.

WARNING

Explains the dangerous conditions that may cause to death or serious accident unless it is avoided.

CAUTION

Explains the conditions that may cause to light or medium injury unless it is avoided.

CAUTION

Explains the conditions that may damage to equipment unless it is avoided.

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

Consecutive numbers in operating procedures indicate the sequence of successive operations.

[Note]

Indicates a comment or supplementary information. Indicates a reference.

8

Chapter 1 Safety

Chapter 1

Safety

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

1-1

Chapter 1 Safety

Chapter 1 Safety 1. Precautions in Using Endoscope 1) Preparation and inspection before use 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 advantages of the equipment’s capabilities. If the checking results show that there is anything wrong with the equipment, do not use the same equipment. 2) Combination of equipment This product may be used in the combination only with processor VP-4400. Do not use in combination with other equipment than the above and also as a light source unit for Fiberscope. The Endoscope may be used in combination with peripherals. To avoid an electric shock accident, do not use any peripherals that do not conform to the medical safety standards. 3) Maintenance The equipment will wear out and degrade after repeated use for a long period. Have it checked by specialists once every six months. Also have it checked if there is anything wrong with the equipment. Do not disassemble or modify the equipment. 4) Temperature at distal end When the Endoscope projects light at high brightness for an extended time, the temperature may exceed 41°C at the distal end. Turn off the lamp when you hang the Endoscope on the cart hanger.

1-2

Chapter 1 Safety

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: 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 Pull on rubber gloves when handling an Endoscope to prevent infection and static charges. 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 more details, contact a FUJINON/FUJIFILM distributor in your country.

3. “

WARNING” and “

CAUTION” Messages Appearing in Individual Chapters

Chapter 4 Method of Use 4.1 Installation and Connecting the Equipment and Materials 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 conform to the medical safety standards. It may cause explosion or fire. Do not use the equipment in atmosphere of flammable gas.

1-3

Chapter 1 Safety

Touching the LG connector with hands immediately after use of the Endoscope may cause to burn. Do not touch the LG connector tip until it will be cooled down (approximately 5 minutes). 4.3 Lighting the Lamp It may damage your eyes. Do not look the lamp directly while the lamp is lighting. Do not look the illumination of Endoscope directly. Chapter 5 Storage and Maintenance 5.2.2 Storage of Water Tank It may cause infection. Dry the water tank before storing it. 5.6 Replacement of Main Lamp It may cause electric shock. Before replacing the lamp, unplug the power cord from the receptacle. Touching the lamp just after it is used may cause a burn injury. Do not touch the lamp by hand until it has cooled (60 minutes). 5.8 Cleaning of Water Tank There is a danger that it may not be disinfected or sterilized sufficiently. After using the water tank, clean it immediately. 5.9 Disinfection of Water Tank Vapor of the antiseptic solution may adversely affect the human body. During the disinfection, keep the air circulating fully. Before dipping, put the lid on the dipping bath.

1-4

Chapter 2 Composition of XL-4400 and System Configuration

Chapter 2

Composition of XL-4400 and System Configuration

This chapter describes the composition of the XL-4400 set and system configuration.

2.1 Composition of XL-4400 ... 2-2 2.2 Standard System Configuration ... 2-3 2.3 Extended System Configuration ... 2-4

2-1

Chapter 2 Composition of XL-4400 and System Configuration

Chapter 2 Composition of XL-4400 and System Configuration 2.1 Composition of XL-4400 The XL-4400 consists of the following items. [Note] Figures in parentheses indicate quantities.

Light Source XL-4400 (1)

Operation Manual (1)

2-2

Chapter 2 Composition of XL-4400 and System Configuration

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

Water Tank WT-2

Light Source XL-4400

Processor VP-4400

LCD Monitor CDL1904A CDL1566A RadiForce R12 (NANAO) RADIANCE23 (NDS) Note1 LMD-2450MD (SONY) Note1

Endoscope 400 Series 500 Series

Connecting Cable CC1-9R3 (attached with VP-4400)

Data Keyboard DK-4400E

Cart PC-310

Note1: When using HD-SDI output of VP-4400 -HD-

2-3

Chapter 2 Composition of XL-4400 and System Configuration

2.3 Extended System Configuration You can extend the EPX-4400 system by connecting various equipment to the standard system configuration. Extension makes the following possible. Endoscopic treatment Ultrasonography through the forceps channel Recording of Video images Printout of still images

Sonoprobe System

Ultrasonic Processor SU-7000

Light Source XL-4400 Water Tank WT-2

Processor VP-4400 Endoscope 400 Series 500 Series

Data Keyboard DK-4400E

Cart PC-310

2-4

Chapter 2 Composition of XL-4400 and System Configuration

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

LCD Monitor CDL1904A CDL1566A RadiForce R12 (NANAO) RADIANCE23 (NDS) Note1 LMD-2450MD (SONY) Note1

Video Monitor PVM-14L2MD (SONY)

Printer UP-51MD (SONY) UP-55MD (SONY) UP-21MD (SONY) CP900UM(120V)(MITSUBISHIELECTRIC) CP900E(230V)(MITSUBISHIELECTRIC) CP900DW(MITSUBISHIELECTRIC)

VCR DSR-20MD (SONY)

Electrosurgical Instrument ICC 200 (ERBE)

Note1: When using HD-SDI output of VP-4400 -HD-

2-5

Chapter 2 Composition of XL-4400 and System Configuration

2-6

Chapter 3 Names and Functions of Parts

Chapter 3

Names and Functions of Parts

This chapter describes the names and functions of the XL-4400.

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

3-1

Chapter 3 Names and Functions of Parts

Chapter 3 Names and Functions of Parts 3.1 Front Panel

1

2

3

13

4

5

12

6

7

8

11

9

10

Scope Socket Used to connect the LG connector of the Endoscope.

Air Supply Lamp (LOW, NORM) Displays the air supply pump lever, “Normal” or “Low.”

Indicator Indicates the amount of illumination while the lamp ON. Indicates the integrated lighting hours of the main lamp (three steps lamp OFF. Display of ALC Level (LEVEL) Indicates the level of automatic light control from the value of -8 to +8.

3-2

100 hours) while the