VP-4450HD and XL-4450 Installation Manual

Important Safety Information

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

1. Safety Read and understand this manual carefully before installing this 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.”

2. 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.”

3. Combination of Equipment This system may be used in combination with peripherals. To avoid an electric shock accident, use only the peripherals described in “2.1 Equipment Using in Combination” (page 2-2).

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

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

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Contents

Contents Important Safety Information ...2 Preface ...4 Conventions Used in This Manual...4 Chapter 1

Safety ... 1-1

Chapter 2

System Configuration ... 2-1 2.1 Equipment Using in Combination ... 2-2 2.2 Standard System Configuration ... 2-3 2.3 Extended System Configuration ... 2-4

Chapter 3

System Installation ... 3-1 3.1 Installing the Standard System ... 3-3 3.2 Installing the Extended System ... 3-13 3.3 Connecting the Power Source ... 3-15

Chapter 4

Initial Settings... 4-1 4.1 Setting the Hospital Name, Date and Time ... 4-2 4.2 Setting Scope Switch ... 4-9 4.3 Setting Foot Switch (FS1) ... 4-14 4.4 Setup for Switching the Shutter Speed ... 4-17

Appendix ...Appendix-1 Index ...Appendix-2

3

Preface

Preface This manual describes how to install this system. This system is composed of the VP-4450HD processor and XL-4450 light source, and is used in combination with a 400 or 500 system scope and other peripherals. The 400 system scopes which can be use include the 410, 450 or 470 scopes (only scopes manufactured in 2004 or later). The peripherals include: LCD monitor, cart, printer, ultrasonic processor and electrosurgical instrument. For details of the connections of the ultrasonic processor and the electrosurgical instrument, refer to the respective operation manuals.

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) Combination of equipment This system may be used in combination with peripherals. To avoid electric shock, use only the peripherals described in “2.1 Equipment Using in Combination” (page 2-2). 2) Installation of equipment To avoid electric shock and equipment toppling over, observe the following precautions. <To avoid electric shock> • Do not take the power source for the electrosurgical unit from the cart. • Do not take the power for the second cart from the first cart. • Do not use a 3p /2p conversion plug. • Do not connect any unit other than the equipment composing this system to the power outlet of the cart. <To avoid toppling over of equipment> • Do not stack the peripherals. • Make sure that the feet of each unit are placed inside of the stoppers. <To avoid malfunction due to lightning> • Connect the equipment to a power source suitable for the structure and facilities of the hospital or clinic. 3) Maintenance 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 or when the cumulative lighting time of the XL-4450 reaches 500 hours. Also, the equipment is required to be inspected if any problem is found in the equipment. Do not disassemble or modify the equipment. For the inspection, consult your local dealer. [Note] Even though the cumulative time of lamp use does not yet reach 500 hours, if the amount of light emitted from the main lamp (Xenon) decreases, replace the main lamp with a new one immediately.

1-2

Chapter 1 Safety

4) Potential Equalization This system is equipped with an equipotential terminal. Use it as an equipotential grounding, if necessary. 5) 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. Rated value of XL-4450 Xenon Lamp LMP-002 is 300W. 6) Transferring the equipment The heavy weight of the XL-4450 light source may cause physical injuries when moving it. Move it using two persons. 7) 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.

1-3

Chapter 1 Safety

2. “ WARNING” and “ CAUTION” Messages Appearing in Individual Chapters Chapter 3 System Installation It may cause a fire or electric shock. Use the rated voltage only. It may cause an electric shock. Connect the power plug to a protective earth receptacle. Use peripherals that are compliant with the medical safety standards. It may cause explosion or fire. Do not use the equipment in atmosphere of flammable gas.

1-4

Chapter 2

System Configuration

This chapter describes the system configuration and equipment which can be used in this system.

2.1 Equipment Using in Combination ...2-2 2.2 Standard System Configuration ...2-3 2.3 Extended System Configuration ...2-4

2-1

Chapter 2 System Configuration

Chapter 2 System Configuration 2.1 Equipment Using in Combination The equipment using in combination is divided into the following three types according to its power connection. 1) Equipment which is directly combined with this system (Applicable to EN 60601-1) This system, itself and the equipment configuring this system Examples of such equipment are shown in Table 2.1. 2) Equipment which can be used when its power is supplied from a power source other than the cart in which this system is installed. (Applicable to EN 60601-1) Examples of such equipment are shown in Table 2.2. 3) Peripherals which are used when required power is supplied from an insulated transformer applicable to EN 60601-1 (Applicable or conforming to EN 60601-1 or EN 60950) Examples of such equipment are shown in Table 2.3. The equipment other than these three types may not be safe. Do not use such equipment. [Note] These combinations are determined based on the viewpoint of electrical safety. The performance of the equipment depends on the specifications of the manufacturers. Table 2.1 equipment configuring the system Type

Model name

Processor

VP-4450HD

Light Source

XL-4450

Data Keyboard

DK-4450E

Endoscope

The 410, 450 or 470 system scopes (only scopes manufactured in 2004 or later) 500 system scopes

Table 2.2 Medical equipment used when its power is supplied from other power source Type

Model name (example)

Ultrasonic Observation Unit

SP702, SU-7000 Note 1

Electrosurgical Unit

ICC200 (ERBE)

Table 2.3 Peripherals used when its power is supplied from an insulated transformer Type

Model name (example)

LCD Monitor

CDL1909A, CDL1576A, RADIANCE24 (NDS)

Printer

UP-55MD (SONY), UP-21MD (SONY) Note 1 CP900UM (120V) (MITSUBISHI ELECTRIC) Note 1 CP900E (230V) (MITSUBISHI ELECTRIC) Note 1 CP900DW (MITSUBISHI ELECTRIC)

Note 1: This equipment cannot use the peripheral connector of VP-4450HD for the connection.

2-2

Chapter 2 System Configuration

2.2 Standard System Configuration The standard system configuration is the minimum configuration required for general endoscopy.

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 System Configuration

2.3 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 • Printing of still images • Recording of still images

Sonoprobe System

Water Tank WT-2

Ultrasonic Processor SU-7000

Light Source XL-4450

Processor VP-4450HD Endoscope The 500 System Scope The 400 System Scope

Data Keyboard DK-4450E

Cart

2-4

Chapter 2 System Configuration

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

Electrosurgical Instrument ICC 200 (ERBE)

LCD Monitor CDL1909A CDL1576A RADIANCE24 (NDS)

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

2-5

Chapter 2 System Configuration

2-6

Chapter 3

System Installation

This chapter describes how to install this system.

3.1 Installing the Standard System ...3-3 3.2 Installing the Extended System ...3-13 3.3 Connecting the Power Source ...3-15

3-1

Chapter 3 System Installation

Chapter 3 System Installation WARNING It may cause a fire or electric shock. Use the rated voltage only. It may cause an electric shock. Connect the power plug to a protective earth receptacle. Use peripherals that are compliant with medical safety standards. It may cause explosion or fire. Do not use the equipment in atmosphere of flammable gas. [Note] Do not use a 3p-2p conversion plug as it cannot provide protective earth.

CAUTION It may cause overheat on equipment. Do not block ventilation holes. The equipment may fall off. Secure the monitor to the cart. It may tip over or cause damage. Install the equipment on a level location fee from vibration and shock. It may cause trouble to the equipment. Use the rated voltage only. [Note] Images may not be displayed properly. For the DVI cable connecting the LCD monitor to the processor, use either the cable that comes with the monitor or one of 5m or less based on the DVI standards. [Note] Packaging material has been placed inside the lamp house cover of the XL-4450. Remove the material before installing this system. “3.1 Installing the Standard System” (page 3-3).

3-2

Chapter 3 System Installation

3.1 Installing the Standard System (1) Lock the casters of the cart.

(2) Remove two screws on the real panel of the cart to take off the rear cover.

(3) Insert the attached power cord into the power supply connector on the rear panel of the processor VP-4450HD and connect it securely. [Note] Do not use the power cord other than the attached one. Make sure that the power cord is the attached one by checking the model number described on the power cord.

VM0306B

[Note] Even when the power cord is already connected, make sure that the power cord is connected securely.

3-3

Chapter 3 System Installation

(4) Mount the processor VP-4450HD on the movable shelf of the cart.

[Note] To avoid anything toppling over, make sure that the feet of each unit are placed inside the stoppers.

(5) Insert the attached power cord into the power supply connector on the rear panel of the light source XL-4450 and connect it securely. [Note] Do not use the power cord other than the attached one. Make sure that the power cord is the attached one by checking the model number described on the power cord. [Note] Even when the power cord is already connected, make sure that the power cord is connected securely. (6) Rotate the knurled knob on the left panel to open the lamp house cover.

3-4

FUSE

VM0306B

Chapter 3 System Installation

(7) Remove the tape on the lock cover, and take out the packaging material.

(8) Close the lamp house cover and rotate the knurled knob to fix it firmly.

(9) Place one hand under one side of the bottom of the light source and lift it up.

(10) While lifting the bottom up, place the other hand under the bottom of the front panel.

3-5

Chapter 3 System Installation

(11) In the same manner, the other person lifts up the other side of the unit.

(12) Hold the unit steadily using two persons.

(13) Place the unit over the processor gently using two persons.

(14) While holding the rear panel of the processor to avoid it shifting, slide in the light source.

3-6