PB-30 Balloon Controller Operation Manual Ver 1.0

Important Safety Information

Important Safety Information 1. Intended Use This product is a device to feed air to or evacuate a balloon that assists insertion of an endoscope into the small intestine at a medical facility under the management of a physician. Never use this equipment for any other purposes. This product cannot be used to send air to the endoscope. In addition, it is presumed that only medical personnel, who understand the mechanisms and operation procedures of this product, will be allowed to use it. This product is not intended for use for any child or baby.

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

3. Warning Items that must be observed for safety when using the balloon controller are identified by “ WARNING” or “ CAUTION.” Perform procedures correctly by reading and understanding the warning information carefully.

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

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Important Safety Information

4. 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.

5. When Using Balloon Controller for the First Time The tube kit for the balloon controller has not been sterilized. When using it for the first time, clean and sterilize it.

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

7. Foreign Substance and Liquid Foreign substance or liquid may cause fire or electric shock if it enters inside of this product. In such a case, stop using the equipment immediately, disconnect the power plug from the power outlet, and contact your local FUJIFILM dealer.

8. If Any Abnormality Occurs During Clinical Procedure If any abnormality occurs with the equipment or any error code is indicated, refer to Chapter 12 “Troubleshooting.”

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Contents

Contents Important Safety Information...2 Preface...6 Conventions Used in This Manual...6 Chapter 1

Safety...7

Chapter 2

Composition of PB-30 and System Configuration...11 2.1 Composition of PB-30...11 2.2 System Configuration...12

Chapter 3

Name and Function of Each Part...13 3.1 Main Unit (PB-30)...13 3.2 Remote Switch (RC-30)...17 3.3 Tube Kit [Note] Optional Accessory...20 3.4 Foot Switch (FS1) [Note] Optional Accessory...22 3.5 Symbols...23

Chapter 4

Pressure Display...24 4.1 Outline...24 4.2 Pressure Value Display...24 4.3 Pressure Indicator Display...25 4.4 Error Code Display...25

Chapter 5

Graphic Display...26 5.1 Outline...26 5.2 Graphic Display...26

Chapter 6

Preparation and Inspection...28 6.1 Connecting PB-30 and an External Monitor...29 6.2 Attaching the Filter and Tube...29 6.3 Installation of PB-30...34 6.4 Connecting PB-30 and the Endoscope...36 6.5 Inspecting PB-30...38 6.6 Installation and Operation of Foot Switch...44

Chapter 7

How to Use the Equipment...45 7.1 Operating the Balloon...45 7.2 Completion of Examination...48 7.3 Removing PB-30...49

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Contents

Chapter 8

Cleaning...51 8.1 Conditions of Cleaning...51 8.2 Necessary Equipment and Materials...52 8.3 Cleaning...53

Chapter 9

Chemical Disinfection...55 9.1 Methods of Chemical Disinfection...55 9.2 Conditions of Disinfection...56 9.3 Chemical Disinfection of Balloon...57 9.4 Disinfection of Tube Kit...59

Chapter 10 Sterilization...61 10.1 Methods of Sterilization...61 10.2 Sterilizing Tube Kit...62 10.3 Autoclave...63 10.4 Sterilization of Balloon...64 Chapter 11 Storage and Maintenance...65 11.1 Maintenance after Use...65 11.2 Storage...66 Chapter 12 Troubleshooting...67 12.1 Troubleshooting...67 12.2 If the Buzzer Sounds...70 12.3 Error Codes...72 Main Specifications...73 Warranty and After-Sales Service...79 Disposal of Electric and Electronic Equipment...80 Index...81 Service Centers...82

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Preface

Preface This manual describes how to use the balloon controller PB-30 as well as how to clean, disinfect, sterilize and store it. PB-30 is used in combination with an endoscope for G.I. tract. For details on how to use it, refer to the operation manual of each endoscope.

Conventions Used in This Manual This manual uses the following conventions for easier understanding. General Conventions Convention

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

WARNING

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

CAUTION

Explains situations that may cause injury if not avoided.

CAUTION

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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Chapter 1 Safety

Chapter 1 Safety 1. Precautions in Using the Product 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 inspect 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. If the inspection result shows any abnormality, do not use the same equipment. 2) Combination of equipment This product is used in combination with an endoscope system. In order to avoid unexpected accidents, do not use this product except in combination with components or systems described in Chapter 2. Refer to “<Devices Used in Combination>” in “Main Specifications” for the combinations of endoscopes, over-tubes and tube kits. In order to avoid unexpected accidents and take full advantage of the equipment’s capabilities, read the operation manual of the equipment carefully before using it. 3) Abnormality in use If any abnormality is noticed during use, carry out safety checks and discontinue use immediately. 4) Maintenance The equipment will wear out and degrade after repeated use for a long period. In particular, resin and rubber parts wear out over time or due to the chemicals used. Have it checked by specialists once every six months or once every 100 cases, whichever comes first. Also have it checked if there is anything wrong with the equipment. Never disassemble or modify the equipment.

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Chapter 1 Safety

5) Electromagnetic interference This equipment has been tested and found to comply with the limits for medical devices defined in EN 60601-1-2:2007. 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, even though 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 this product 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. This product may be affected by electromagnetic interference. If it occurs, turn off any object causing such interference, or keep it far away from this product.

WARNING Do not place any objects that emit strong electromagnetic waves near this product. Otherwise, malfunction of this product may occur.

CAUTION Noise may appear on the monitor of this product 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 product. Use the cable specified in this manual to connect this product and an external monitor. Use of other cables may cause an increase in electromagnetic emission or decrease in electromagnetic immunity of this product.

2. Cleaning and Sterilization The tube kit of this balloon controller has not been sterilized. When using it for the first time, perform cleaning and sterilization suitable for the application. After using it, clean and sterilize it according to the procedures in this manual. Inadequate cleaning and sterilization may result in infection. Wear personal protective equipment during chemical cleaning and sterilization to protect your skin and to prevent infection.

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Chapter 1 Safety

3. Disposal 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.

4. “ Warning” and “ Caution” Messages Appearing in Individual Chapters Chapter 6 Preparation and Inspection 6.1 Connecting PB-30 and an External Monitor If an external monitor is used, connect the power cable to receptacles for peripherals on the cart or a receptacle via an insulating transformer. Not doing so may increase the enclosure leakage current, posing a risk of injury or electric shock to the patient and/or the physician when he/she comes into contact with those devices. Connect the external monitor in accordance with the specification of the insulating transformer. 6.3 Installation of PB-30 Use the power source at the rated voltage. Only use the power cord provided with this product. Improper use of power may cause electric shock or fire. Connect the power plug to the protective earth receptacle. Do not set up this product in locations where there is any risk of contact with water. No one except service personnel should open the cover. There is a risk of accidents by electric shock. Do not take power from a power strip placed on the floor. There is a risk of accidents by electric shock. Do not take power for the second power strip from the first power strip. Impedance of protective earth may increase and there is a risk of accidents by electric shock. Do not connect any unit other than the equipment composing this system to the power strip. Leakage current may increase, posing a risk of injury or electric shock to the patient and/or the physician when he/she comes into contact with the device. If the power cords of the peripherals are connected without using the insulation transformer, the enclosure leakage current may increase, posing a risk of injury or electric shock to the patient and/or the physician when he/she comes into contact with those devices. Do not simultaneously touch the patient and any terminals of the devices that make up the system. Doing so may cause electric shock. Do not use the equipment in atmosphere of flammable gas. Doing so may cause explosion or fire. If the inspection result shows any abnormality, do not use the equipment. Use of faulty equipment may cause misdiagnosis or injury. Chapter 7 How to Use the Equipment 7.1 Operating the Balloon Do not operate the balloon forcibly. Doing so may damage mucous membrane.

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Chapter 1 Safety

Chapter 8 Cleaning 8.1 Conditions of Cleaning Clean and sterilize (or disinfect) this product properly according to the procedures described in this manual, immediately after an examination is completed. There is a risk of infection and/or damaging this product. Chapter 9 Chemical Disinfection 9.3 Chemical Disinfection of Balloon The balloon must be completely immersed in chemical solution. Remove air bubbles completely. If any air bubbles remain, effective disinfection cannot be achieved and an inadequately disinfected balloon may pose an infection risk. 9.4 Disinfection of Tube Kit The tube kit must be completely immersed in chemical solution. Remove air bubbles completely. If any air bubbles remain, effective disinfection cannot be achieved and an inadequately disinfected tube kit may pose an infection risk. Chapter 10 Sterilization 10.4 Sterilization of Balloon Proceed with gas sterilization after removing moisture from the balloon. Applying gas sterilization to wet surfaces may compromise sterilization. Proceed with aeration after gas sterilization. Gas residuals remaining in the balloon after gas sterilization may be harmful to the human body. Chapter 11 Storage and Maintenance Dry the tube kit before storing them. If the tube kit is stored without drying it, there is a risk of infection.

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Chapter 2 Composition of PB-30 and System Configuration

Chapter 2 Composition of PB-30 and System Configuration 2.1 Composition of PB-30 The PB-30 set consists of the following items. [Note] Figures in parentheses indicate quantities.

Main unit PB-30 (1)

Remote switch RC-30 (1)

Power Cord (1)

PE

O I AT

R N

O AN

M U AL

Operation manual (1)

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Chapter 2 Composition of PB-30 and System Configuration

2.2 System Configuration The balloon controller is used in combination with the applicable endoscope and over-tube. [Note] Refer to “<Devices Used in Combination>” in “Main Specifications” for the combinations of endoscopes, over-tubes and tube kits.

Endoscope [Note 1] EC-450BI5 EN-450P5/20 EN-450T5 EN-450T5/W EN-530T EN-580T EN-580XP EI-580BT

Monitor [Note 1]

Remote switch RC-30

Foot switch FS1 Balloon BS-2 BS-4

Over-tube TS-12140 TS-13140 TS-13101 TS-1214B TS-1314B TS-1114B

[Note 1]

Balloon controller PB-30

Tube kit TY-04 (optional accessory) TY-06 (optional accessory) TY-400 (optional accessory) TY-500 (optional accessory)

Cart [Note 1]

[Note 1] A  ccessory equipment connected to the analog and digital interfaces must be in compliance with the nationally harmonized IEC standards (i.e. IEC 60950 for data processing equipment, IEC 60065 for video equipment, IEC 61010-1 for laboratory equipment, and IEC 60601-1 for medical equipment.) Furthermore all configurations shall comply with the requirement for ME systems of IEC60601-1. Everybody who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore, responsible that the system complies with the requirement for ME systems of IEC60601-1. If in doubt, consult the technical services department or your local representative.

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Chapter 3 Name and Function of Each Part

Chapter 3 Name and Function of Each Part 3.1

Main Unit (PB-30)

<Front Panel>

8

1

7

2

6

3

5

4

1

Power button This switch is used to turn on/off the power. When the power is on, the green LED on the left side is lit.

2

Display mode toggle switch This switch is used to toggle between “pressure value display mode" and "pressure indicator display mode.”

3

Balloon switch 2 (Black: Endoscope side) This switch is used to start/stop supplying air to or discharging air from the balloon on the endoscope side. When this switch is pressed while the green light is off, the light turns on and air discharge starts. To start air supply, use the remote switch. When this switch is pressed while the green light is on, the light turns off and air supply or discharge stops.

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Chapter 3 Name and Function of Each Part

4

Tube connector 2 (Endoscope side) The tube 2 is connected to this part through the filter of the tube kit.

5

Tube connector 1 (Over-tube side) The tube 1 is connected to this part through the filter of the tube kit.

6

Balloon switch 1 (White: Over-tube side) This switch is used to start/stop supplying air to or discharging air from the balloon on the over-tube side. When this switch is pressed while the green light is off, the light turns on and air discharge starts. To start air supply, use the remote switch. When this switch is pressed while the green light is on, the light turns off and air supply or discharge stops.

7

Stop switch While the buzzer is sounding, if you press this switch, the buzzer stops sounding.

8

Pressure display The pressure value or pressure indicator is displayed with LEDs.

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Chapter 3 Name and Function of Each Part

<Back Panel>

1 8

2 3

7

4

6 5 1

Remote terminal The cable of the remote switch is connected to this terminal.

2

S video terminal A component signal separated into a Y signal for brightness and a C signal for color is output. An external monitor to graphically show the balloon conditions is connected to this terminal. Chapter 5 “Graphic Display” [Note] Use the cable CC2-901, CC2-903, CC3-601, CC3-603 or CC3-608 to connect an external monitor. Video output terminal An external monitor to graphically show the balloon conditions is connected to this terminal.

3

Chapter 5 “Graphic Display” [Note] Use the cable BNC-01, BNC-03 or BNC-05 to connect an external monitor.

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Chapter 3 Name and Function of Each Part

4

Foot switch terminal This terminal is used to connect the foot switch (optional accessory).

5

RS232C connector Service personnel use this connector for maintenance and inspection. Normally, this connector is not used.

6

Fuse holder One T2.5A H 250V fuse is contained in each holder.

7

Power cord

8

Equipotential terminal The equipotential plug is connected to this terminal. When this terminal is used, be sure to connect a device that conforms to EN 60601-1.

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Chapter 3 Name and Function of Each Part

3.2 Remote Switch (RC-30) 3.2.1 Name and Function of Each Part of Remote Switch

1 2 5 3

6

4

Toggle switch 1 (White: Over-tube side) This switch toggles between air supply and air discharge to/from the balloon on the over-tube side. When the power is turned on, the inside light turns on and air is discharged from the balloon. When this switch is pressed while the inside light is on, the outside light turns on and air is supplied to the balloon. When this switch is pressed while the outside light is on, the inside light turns on and air is discharged from the balloon.

1

[Note] This switch is disabled if the balloon switch 1 on the main unit is off.

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Chapter 3 Name and Function of Each Part

2

Toggle switch 2 (Black: Endoscope side) This switch toggles between air supply and air discharge to/from the balloon on the endoscope side. When the power is turned on, the inside light turns on and air is discharged from the balloon. When this switch is pressed while the inside light is on, the outside light turns on and air is supplied to the balloon. When this switch is pressed while the outside light is on, the inside light turns on and air is discharged from the balloon. [Note] This switch is disabled if the balloon switch 2 on the main unit is off.

3

Pause switch 2 (Endoscope side) If you press this switch during air supply or discharge to/from the balloon on the endoscope side, air supply or discharge is paused. The switch lights up during pausing. [Note] When immediately after the power source ON, air is not supplied or discharged until the line pressure reaches -6.0 kPa.

4

Stop switch While the buzzer is sounding, if you press this switch, the buzzer stops sounding.

5

Pause switch 1 (Over-tube side) If you press this switch during air supply or discharge to/from the balloon on the over-tube side, air supply or discharge is paused. The switch lights up during pausing. [Note] When immediately after the power source ON, air is not supplied or discharged until the line pressure reaches -6.0 kPa.

6

RC connector Connects to the remote terminal of the main unit.

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Chapter 3 Name and Function of Each Part

3.2.2 Operation of Remote Swtich Switch operation

Switch state

Air supply or discharge Air is discharged from the balloon or over-tube.

Power-on

Inside light: On Outside light: Off

When pressed once

Inside light: Off Outside light: On

Air is supplied to the balloon or over-tube.

Inside light: On Outside light: Off

Air is discharged from the balloon or over-tube.

When pressed once again

Toggles when pressed

When the balloon switch on the main unit is off

Inside light: Off Outside light: Off

[Note] ‌When the power is turned on, both the toggle switches 1 and 2 are set to air discharge.

Air supply or discharge to/from the balloon and over-tube stops. [Note] Operation of each toggle switch is disabled.

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Chapter 3 Name and Function of Each Part

3.3 Tube Kit [Note] Optional Accessory [Note] Use the tube kit in combination with the devices in “Main Specifications”. [Note] The filter and tube are consumable supplies. Replace them with new once a month or once every 10 cases, whichever comes first.

3.3.1 TY-04 and TY-06

1

1 2

2

3

4

4

TY-04 [Note] Optional accessory

1

3

4 TY-06 [Note] Optional accessory

Filter If the balloon is broken, body fluid that flows backwards is trapped here.

2

Tube 2 (Endoscope side) This tube (transparent) is used to connect the main unit and endoscope.

3

Tube 1 (Over-tube side) This tube (white) is used to connect the main unit and the over-tube.

4

Label for tube identification This label identifies tube 1 and tube 2. The tube 1 is used on the over-tube side. The tube 2 is used on endoscope side.

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