OBCU BALLOON CONTROL UNIT Instructions Jan 2019

Contents

Contents Labels and Symbols ...

1

Important Information - Please Read Before Use...

4

Intended use ...

4

Instruction manual ...

4

Applicability of endoscopy and endoscopic treatment ...

5

User qualifications ...

5

Instrument compatibility ...

6

Prohibition of improper repair and modification ...

6

Signal words ...

6

Dangers, warnings and cautions...

7

Summary of the balloon control unit functions ...

12

Chapter 1

Checking the Package Contents...

13

Chapter 2

Nomenclature and Functions ...

14

2.1

Balloon control unit ...

14

2.2

OBCU remote controller...

17

2.3

Reservoir tank...

18

2.4

Single use splinting tube (ST-SB1) ...

19

Installation and Connection ...

21

3.1

Installation work flow...

22

3.2

Installation of the balloon control unit...

23

3.3

Connection of the OBCU remote controller ...

25

3.4

Installation and connection of the reservoir tank...

26

3.5

Connection to power supply...

28

Preparation and Inspection ...

30

4.1

Preparation before use ...

30

4.2

Inspection of the reservoir tank...

32

4.3

Inspection and connection of the single use splinting tube...

33

4.4

Preparation of the OBCU remote controller cover ...

34

4.5

Checking the power function...

35

4.6

Checking the function of the pump and balloon...

36

4.7

Inspecting the pressure control mechanism ...

37

Chapter 3

Chapter 4

BALLOON CONTROL UNIT OBCU

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Contents

Chapter 5

Operation...

38

5.1

Operation work flow ...

42

5.2

Turning the balloon control unit ON ...

43

5.3

Operation of the balloon...

43

5.4

Disconnect the air flow tube ...

46

5.5

Turning the power OFF ...

46

Chapter 6

Fuse replacement ...

47

Chapter 7

Care, Storage and Disposal ...

49

7.1

Care of the balloon control unit (OBCU) ...

50

7.2

Care of the OBCU remote controller (MAJ-1726) ...

50

7.3

Storage of the balloon control unit (OBCU) and  OBCU remote controller (MAJ-1726) ...

51

Disposal of the balloon control unit (OBCU) and  OBCU remote controller (MAJ-1726) ...

51

Disposal of the reservoir tank (MAJ-1727)...

51

Troubleshooting ...

52

8.1

Troubleshooting guide ...

52

8.2

Troubleshooting guide when the alarm (intermittent tone) sounds .

55

8.3

Troubleshooting guide when the alarm (continuous tone) sounds..

57

8.4

Withdrawal of the endoscope and single use splinting tube with an abnormality ...

58

Returning the balloon control unit for repair ...

60

Appendix...

61

System chart ...

61

Transportation, storage and operating environments ...

63

Specifications ...

64

EMC information...

67

7.4 7.5

Chapter 8

8.5

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BALLOON CONTROL UNIT OBCU

Labels and Symbols

Labels and Symbols Safety-related labels and symbols are attached to the balloon control unit at the locations shown below. If labels or symbols are missing or illegible, contact Olympus.

 Front panel

UDI label The UDI label is required by some countries’ regulations regarding the identification of a medical device also known as Unique Device Identification (UDI).

TYPE BF applied part symbol

Balloon inflation

Balloon deflation

Pause

Balloon inflation/deflation The caution symbol indicates that only the specified reservoir tank can be connected.

BALLOON CONTROL UNIT OBCU

Reservoir tank connector

1

Labels and Symbols

 OBCU remote controller

Pause Balloon inflation

Balloon deflation

Balloon inflation/deflation

2

BALLOON CONTROL UNIT OBCU

Labels and Symbols

 Rear panel Electrical rating The product name, rated voltage and frequency are shown.

The caution symbol indicates that only the specified cable can be connected.

BALLOON CONTROL UNIT OBCU 50/60Hz 150 VA INPUT 100 – 240V

Crossed-out wheeled bin’ symbol CE marking

Fuse rating FUSES T3.15AL250V

Serial number plate CSA/UL marking

Manufacturer

Potential equalization terminal

 Back cover of this instruction manual

Manufacturer

Authorized representative in the European Community

For US Customers only For a Symbols Glossary, visit us:  http://www.olympus-global.com/en/common/pdf/symbolsglossary.pdf BALLOON CONTROL UNIT OBCU

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Important Information - Please Read Before Use

Important Information - Please Read Before Use Intended use This balloon control unit has been designed for inflating and deflating the balloon attached to the distal end of a single use splinting tube in order to assist the insertion of an Olympus-designated small intestinal endoscope. Do not use this instrument for any purpose other than its intended use. Also, note that this instrument cannot be used on pediatric patients.

Instruction manual This instruction manual contains essential information on using this balloon control unit safely and effectively. Before use, thoroughly review this manual and the manuals of all equipment which will be used during the procedure and use the equipment as instructed. Keep this and all related instruction manuals in a safe, accessible location. If you have any questions or comments about any information in this manual, please contact Olympus.

 Terms used in this manual Single use splinting tube: The single use splinting tube is used to assist the insertion of the endoscope. Pass the endoscope through the single use splinting tube. Hospital-grade power outlet: The hospital-grade power outlet is a wall AC mains power outlet socket with a terminal used exclusively for grounding. Air flow tube: The air flow tube is connected between the reservoir tank and the single use splinting tube.

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BALLOON CONTROL UNIT OBCU

Important Information - Please Read Before Use

Balloon: The balloon is attached at the end of the single use splinting tube and inflates or deflates through the air feed or suction by the balloon control unit (OBCU). Reservoir tank: The reservoir tank prevents liquid from entering the balloon control unit. OBCU remote controller (MAJ-1726): The remote controller controls the balloon control unit (OBCU).

Applicability of endoscopy and endoscopic treatment If there is an official standard on the applicability of endoscopy and endoscopic treatment that is defined by the hospitals administration or other official institutions such as academic societies on endoscopy, follow that standard. Before starting endoscopy and endoscopic treatment, thoroughly evaluate its properties, purposes, effects, and possible risks (their natures, extent, and probability). Perform endoscopy and endoscopic treatment only when its potential benefits are greater than its risks. Explain to the patient that the balloon at the distal end of the splinting tube is used to assist the insertion of the endoscope. Fully explain the potential risks or complications, such as pancreatitis, perforation, or bleeding. Even after starting the endoscopy and endoscopic treatment, continue to evaluate the potential benefits and risks, and immediately stop the endoscopy/treatment and take proper measures if the risks to the patient become greater than the potential benefits.

User qualifications If there is an official standard on user qualifications to perform endoscopy and endoscopic treatment that is defined by the medical administration or other official institutions, such as academic societies on endoscopy, follow that standard. If there is no official qualification standard, the operator of this instrument must be a physician approved by the medical safety manager of the hospital or person in charge of the department (department of internal medicine, etc.). The physician should be capable of safely performing the planned endoscopy and endoscopic treatment following guidelines set by the academic societies on endoscopy, etc., and considering the difficulty of endoscopy and endoscopic treatment. This manual does not explain or discuss endoscopic procedures.

BALLOON CONTROL UNIT OBCU

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Important Information - Please Read Before Use

Instrument compatibility Refer to the“System chart” in the Appendix to confirm that this balloon control unit is compatible with the ancillary equipment being used. Using incompatible equipment can result in patient injury and/or equipment damage. Also review the manuals of all equipment that will be used during the procedure and use the equipment as instructed. This instrument complies with the EMC standard for medical electrical equipment, edition 4 (IEC 60601-1-2: 2014). When connecting to an instrument that complies with a previous edition of the EMC standard for medical electrical equipment edition, the EMC characteristics could be vulnerable.

Prohibition of improper repair and modification This instrument does not contain any user-serviceable parts. Do not disassemble, modify, or attempt to repair it. Patient or operator injury and/or equipment damage can result. Some problems that appear to be malfunctions may be correctable by referring to Chapter 8, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 8, contact Olympus.

Signal words The following signal words are used throughout this manual:

Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage.

Indicates additional helpful information.

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BALLOON CONTROL UNIT OBCU

Important Information - Please Read Before Use

Dangers, warnings and cautions Follow the dangers, warnings, and cautions given below when handling this balloon control unit. This information is to be supplemented by the dangers, warnings, and cautions given in each chapter.

•

As a TYPE BF applied part, this balloon control unit must never be applied directly to the heart and must not be used in procedures involving cardiac observation or surgery. Leakage current from the TYPE BF applied part may be dangerous and cause ventricular fibrillation or otherwise seriously affect the cardiac function of the patient. Accordingly, always adhere to the following points:  Never apply the endoscope connected to this instrument to the heart or any area near the heart.  Never allow an EndoTherapy accessory or another endoscope applied to or near the heart to come in contact with an endoscope connected to this instrument.

•

Strictly observe the following precautions. Failure to do so may place the patient and medical personnel in danger of an electric shock.  When the balloon control unit is used in a patient examination, do not allow metal parts of the endoscope or its accessories to touch metal parts of other system components. Such contact may cause unintended current flow to the patient.  Keep liquids away from all electrical equipment. If fluids are spilled on or into the unit, stop operation of the instrument immediately and contact Olympus.  Do not prepare, inspect, or use this instrument with wet hands.

•

Never install and operate the balloon control unit in locations where:  The concentration of oxygen is high.  Oxidizing agents (such as nitrous oxide (N2O)) are present in the atmosphere.  Flammable anesthetics are present in the atmosphere. Otherwise, explosion or fire may result.

BALLOON CONTROL UNIT OBCU

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Important Information - Please Read Before Use

8

•

Using the balloon control unit in combination with equipment other than that shown in the “System chart” in the Appendix can inhibit its performance and can compromise the safety of the patient and medical personnel. Be always sure to use the balloon control unit in combination with the designated equipment.

•

The balloon control unit may interfere with other medical electronic equipment used in combination with it. Before use, refer to the Appendix to confirm the compatibility of this instrument with all ancillary equipment.

•

Do not use the balloon control unit in any place where it may be subject to strong electromagnetic radiation (for example, in the vicinity of a microwave therapeutic device, MRI, wireless set, short-wave therapeutic device, cellular/portable phone, etc.). Otherwise, malfunction can result.

•

Never insert anything into the ventilation grills of the balloon control unit. Doing so can cause an electric shock and/or fire.

•

Always perform the procedure in a room equipped for radiographic guidance. When operating the endoscope, single use splinting tube, or balloon inflation/deflation, always be prepared to observe the conditions of the endoscope, single use splinting tube, or balloon under radiographic guidance. Otherwise, injury inside the body cavity may result.

•

Do not apply an excessive force to the power cord. Otherwise, an electric shock may result.

•

Do not use a multitap extension plug or extension cord with the power cord. Otherwise, an electric shock may result.

•

Always use a hospital-grade power outlet to prevent an electric shock.

BALLOON CONTROL UNIT OBCU

Important Information - Please Read Before Use

•

If an irregularity is observed, immediately stop the operation. If continuing the operation with an irregularity, patient injury, bleeding, and/or perforation can result, and the single use splinting tube may become impossible to withdraw from the patient. If the balloon does not deflate even if the balloon control unit (OBCU) is operated or if any resistance is felt when inserting or withdrawing the single use splinting tube after balloon deflation, immediately turn the balloon control unit (OBCU) OFF and stop the operation. Check in the X-ray image if the single use splinting tube is bent caused by the distal end of the endoscope being withdrawn into the single use splinting tube. Check if the air flow tube is crushed.  When the distal end of the endoscope is extending from the single use splinting tube, the single use splinting tube is not bent or crushed, deflate the balloon manually as described in Section 8.4, “Withdrawal of the endoscope and single use splinting tube with an abnormality” on page 58 and slowly withdraw the endoscope and single use splinting tube together.  When the distal end of the endoscope is withdrawn into the single use splinting tube and the tube is bent, push the distal end of the endoscope out of the single use splinting tube again (by pushing the endoscope into the single use splinting tube and moving the single use splinting tube backward) while viewing the endoscopic image and X-ray image.  When the air flow tube is crushed, reshape the crushed part of the tube or replace the tube with a new one. If there are still irregularities, deflate the balloon manually as described in Section 8.4, “Withdrawal of the endoscope and single use splinting tube with an abnormality” on page 58 and slowly withdraw the endoscope and single use splinting tube together. When the endoscope and single use splinting tube cannot be withdrawn even if following the instructions as described in Section 8.4, “Withdrawal of the endoscope and single use splinting tube with an abnormality” on page 58, do not attempt to forcibly withdraw it. Should any irregularity be observed, immediately contact Olympus. Forcibly withdrawing the endoscope or the single use splinting tube may cause patient injury, bleeding, and/or perforation.

BALLOON CONTROL UNIT OBCU

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Important Information - Please Read Before Use

•

Use only the specified accessories that are provided. Using other accessories than that provided may inhibit performance. If the accessories are damaged or worn, contact Olympus for replacement.

•

Dispose of the reservoir tank using proper methods, if liquid has pooled in the tank. Otherwise, an infection-control risk may result.

•

Be sure that this instrument is not used adjacent to or stacked with other equipment (other than the components of this instrument or system) to avoid electromagnetic interference.

•

Electromagnetic interference may occur to this instrument when it is placed near equipment marked with the following symbol or other portable and mobile RF (radio frequency) communications equipment such as cellular phones. If radio interference occurs, mitigation measures may be necessary, such as reorienting or relocating this instrument or shielding the location.

•

Do not use a pointed or hard object to press the switches on the front panel of the balloon control unit or the OBCU remote controller. This may damage the switches.

•

Avoid applying excessive force to the connectors. Otherwise, equipment damage or malfunction can result.

•

Strictly observe the following precautions. Otherwise, electric contacts may be damaged and could cause a malfunction:  Do not touch the electric contacts of the OBCU remote controller connection terminal directly with your hand.  Do not subject the OBCU remote controller connection terminal to excessive force.

10

•

Avoid using this instrument in a dusty environment, as this may damage the instrument.

•

If liquid is pooled in the reservoir tank during use, it cannot be reused. Be sure to check for liquid in the reservoir tank after each procedure. If liquid is pooled, replace the tank with a new one. Starting a new procedure while liquid is pooled in the reservoir tank may result in equipment damage.

BALLOON CONTROL UNIT OBCU

Important Information - Please Read Before Use

•

Install or store the balloon control unit in a place where a patient and/or user will not contact the protrusions of the instrument, such as the reservoir tank connector on the front panel. Otherwise, patient and/or operator injury may result.

•

Be sure to use this instrument as instructed in this manual. Disregarding the instructions in this manual may inhibit the performance of this instrument and may result in equipment damage. Before each procedure, inspect the instrument as instructed in this manual.

•

Use this instrument only under the conditions described in Appendix. Otherwise, improper performance or equipment damage may result.

•

Handle the reservoir tank with care. A damaged reservoir tank may cause injury.

•

Properly install the OBCU remote controller. If it is not properly installed, the OBCU remote controller may be damaged. Install the OBCU remote controller on a stable, level surface so that the cable between the balloon control unit and OBCU remote controller is not stretched.

BALLOON CONTROL UNIT OBCU

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Important Information - Please Read Before Use

As defined by the international safety standard (IEC 60601-1), medical electrical equipment is classified into the following types: TYPE CF applied part (the instrument can safely be applied to any part of the body, including the heart), and TYPE B/BF applied part (the instrument can safely be applied to any organ except the heart). The part of the body that an endoscope or electrosurgical accessory can safely be applied to depends on the classification of the equipment to which the instruments are connected. Before beginning the procedure, check the current leakage classification type of each instrument to be used for the procedure. Classification types are clearly specified in the instruments instruction manuals. Symbol

Classification TYPE CF applied part

TYPE BF applied part

TYPE B applied part

Summary of the balloon control unit functions Pressure display This display indicates the pressure of the balloon of the splinting tube. 

See Section 5.2, “Turning the balloon control unit ON” on page 43.

Balloon inflation/deflation Inflates/deflates the balloon of the splinting tube connected to the balloon control unit. 

12

See Section 5.3, “Operation of the balloon” on page 43.

BALLOON CONTROL UNIT OBCU

Chapter 1 Checking the Package Contents

Chapter 1 Checking the Package Contents Match all items in the package with the components shown below. Inspect each item for damage. If the balloon control unit is damaged, a component is missing or you have any questions, do not use the instrument; immediately contact Olympus.

Balloon control unit (OBCU)

Power cord

Spare fuse (MAJ-1751, 2 pcs)

Foot holder (MAJ-1750, 4 pcs)

OBCU remote controller (MAJ-1726)

Reservoir tank (MAJ-1727, 2 pcs)

Instruction manual

Instruction (leaflet type)

BALLOON CONTROL UNIT OBCU

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Chapter 2 Nomenclature and Functions

Chapter 2 Nomenclature and Functions 2.1

Balloon control unit Front panel 3. Tube holder

4. Pressure display

1. Power switch

2. Power indicator 5. Warning indicator

6. Inflation indicator

7. Deflation indicator

8. Pump pause switch

9. Inflate/deflate switch 11. Tank holder

Figure 2.1

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BALLOON CONTROL UNIT OBCU

10. Reservoir tank connector

Chapter 2 Nomenclature and Functions

1. Power switch Press the power switch to turn the balloon control unit ON. The power indicator bellow lights up. Pressing the switch again turns the balloon control unit OFF. 2. Power indicator This indicator lights up when the power is turned ON. 3. Tube holder The tube holder secures the tube of the reservoir tank. 4. Pressure display This display shows current pressure value, operating conditions and warnings. 5. Warning indicator This indicator turns on or blinks when the balloon control unit detects an abnormality. When this indicator lights up, refer to Section 8.2, “Troubleshooting guide when the alarm (intermittent tone) sounds” on page 55. 6. Inflation indicator This indicator blinks when air is fed into the balloon. The indicator lights up when the balloon inflates. 7. Deflation indicator This indicator blinks during air suction from the balloon. The indicator lights up when the balloon deflates. 8. Pump pause switch Pressing this switch causes the pump to pause and maintain the pressure inside the balloon. 9. Inflate/deflate switch Pressing this switch starts air feed/suction. 10. Reservoir tank connector The tube of the reservoir tank is connected to this connector. Air feed or suction is transmitted from here into the reservoir tank. 11. Tank holder This holder secures the reservoir tank.

BALLOON CONTROL UNIT OBCU

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Chapter 2 Nomenclature and Functions

Rear panel

1. Remote controller terminal

2. Potential equalization terminal

3. Fuse box

Ventilation grills

4. AC power inlet

Figure 2.2 1. Remote controller terminal This terminal is the receptacle for the OBCU remote controller cable to connect the balloon control unit to the remote controller. 2. Potential equalization terminal For safety purposes, this terminal is connected to a potential equalization busbar of the electrical installation. 3. Fuse box The fuses protect the balloon control unit from electrical surges. 4. AC power inlet Connect the provided power cord to supply AC power via this inlet.

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BALLOON CONTROL UNIT OBCU

Chapter 2 Nomenclature and Functions

2.2

OBCU remote controller

1. Warning indicator

2. Pump pause switch

5. Inflation indicator

3. Inflate/deflate switch

4. Deflation indicator

6. OBCU remote controller connector

Figure 2.3 1. Warning indicator This indicator turns on or blinks when the balloon control unit detects an abnormality. When this indicator light up, refer to Section 8.2, “Troubleshooting guide when the alarm (intermittent tone) sounds” on page 55. 2. Pump pause switch Pressing this switch causes the pump to pause and maintain the pressure inside the balloon. 3. Inflate/deflate switch Pressing this switch starts air feed/suction. 4. Deflation indicator This indicator blinks during air suction from the balloon. The indicator lights up when the balloon deflates. 5. Inflation indicator This indicator blinks when air is fed into the balloon. The indicator lights up when the balloon inflates.

BALLOON CONTROL UNIT OBCU

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