Operational Manual
76 Pages
Preview
Page 1
English
Balloon Controller
PB-20
OPERATION MANUAL (Ver. 1.0*) Thank you for purchasing our product. Read this manual carefully before use to avoid unexpected accidents, and take full advantage of the product's capabilities.
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 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. Warnings 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 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 balloon controller. Improper operations that will damage the equipment only are identified by “CAUTION.”
2
Important Safety Information
4. 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.
5. When Using the Balloon Controller for the First Time This product has not been sterilized. When using it for the first time, use the level of sterilization suitable to the application, in accordance with Chapter 6 “Washing,” Chapter 7 “Chemical Disinfection,” Chapter 7 “Sterilization.”
6. Operation of the Balloon Controller This balloon controller cannot be used to send air to the Endoscope.
7. If Any Abnormality Occurs During the Clinical Procedure If any abnormality occurs with the equipment or any error code is indicated, refer to Chapter 10 “Troubleshooting.”
3
Important Safety Information Contents
Contents Important Safety Information...................................................................................... 2 Preface ........................................................................................................................ 6 Conventions Used in This Manual ............................................................................. 6 Chapter 1
Safety .................................................................................................. 1-1
Chapter 2
Composition of PB-20 and System Configuration ............................... 2-1 2.1 Composition of PB-20 .................................................................. 2-2 2.2 System Configuration .................................................................. 2-3
Chapter 3
Name and Function of Each Part ......................................................... 3-1 3.1 Main Unit (PB-20) ........................................................................ 3-2 3.2 Remote Switch (RC-20) ................................................................ 3-6 3.3 Tube Kit (TY-04) .......................................................................... 3-8 3.4 Foot Switch (FS-1) ....................................................................... 3-9
Chapter 4
Preparation and Inspection ................................................................. 4-1 4.1 Mounting the Filter and Tube ..................................................... 4-2 4.2 Installation of PB-20 and Remote Switch ..................................... 4-3 4.3 Inspecting the PB-20 ................................................................... 4-5 4.4 Installation and Operation of Foot Switch ................................. 4-11
Chapter 5
How to Use the Equipment .................................................................. 5-1 5.1 Operating Principles .................................................................... 5-2 5.2 Operating the Balloon ................................................................. 5-4 5.3 If the Alarm Sounds ..................................................................... 5-6 5.4 Completion of Inspection ............................................................ 5-7
Chapter 6
Washing .............................................................................................. 6-1 6.1 Conditions of Washing ............................................................... 6-2 6.2 Necessary Equipment and Materials ........................................... 6-3 6.3 Washing ...................................................................................... 6-4
Chapter 7
Chemical Disinfection .......................................................................... 7-1 7.1 Methods of Chemical Disinfection .............................................. 7-2 7.2 Conditions of Disinfection .......................................................... 7-3 7.3 Chemical Disinfection of Tube and Balloon ................................ 7-4
4
Important Safety Information Contents
Chapter 8
Sterilization .......................................................................................... 8-1 8.1 How to Sterilize the Equipment .................................................... 8-2 8.2 Autoclave .................................................................................... 8-3 8.3 Sterilization of Balloon ................................................................. 8-4
Chapter 9
Storage and Maintenance ................................................................... 9-1 9.1 Maintenance after Use ................................................................ 9-2 9.2 Storage ........................................................................................ 9-3 9.3 Replacing Fuses .......................................................................... 9-4
Chapter 10 Troubleshooting ............................................................................... 10-1 Appendix ................................................................................................... Appendix-1 Main specifications ............................................................... Appendix-2 Warranty and After-Sales Service ......................................... Appendix-4 Index ..................................................................................... Appendix-5
5
Important Safety Information Preface
Preface This manual describes how to use the balloon controller PB-20 as well as how to wash, disinfection, sterilize, and store it.
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.
6
Chapter 1 Safety
Chapter 1
Safety
This chapter summarizes the information necessary for safe use of the balloon controller.
1-1
Chapter 1 Safety
Chapter 1 Safety 1. Precautions in Using the Product 1) Inspection before use 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 and take full advantage of the equipment’s capabilities, read the operation manual of the equipment carefully before using it. 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 or once every 100 cases. Also have it checked if there is anything wrong with the equipment. Do not disassemble or modify the equipment. 4) Disposal Obey the procedures set forth in applicable laws and regulations in your area. For details, refer to the dealer from whom you purchased this product. 5) Electromagnetic interference This product conforms to IEC60601-1-2 (2001).
2 . Washing and Sterilization The tube kit of this balloon controllers have not been sterilized. When using them for the first time, perform sterilization of a suitable level for the application. When reusing them, wash, disinfect or sterilize them according to the procedures in the manual. Inadequate washing, sterilization may result in infection. Wear rubber gloves during chemical washing and disinfection to protect your skin and to prevent infection.
1-2
Chapter 1 Safety
3. “
Warning” and “
Caution” Messages Appearing in Individual Chapters
Chapter 4 Preparation and Inspection 4.2 Installation of PB-20 and Remote Switch 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. It may cause explosion of fire. Do not use the equipment in atmosphere of flammable gas. Chapter 5 How to Use the Equipment 5.2 Operating the Balloon It may cause a mucous membrane injury. Do not do impossible operation. Chapter 8 Sterilization 8.3 Sterilization of Balloon Applying gas sterilization to wet parts presents incomplete sterilization. Proceed gas sterilization after vaporizing water out of balloon. Gas remaining in balloon after gas sterilization is harmful to human body. Proceed aeration after gas sterilization. Chapter 9 Storage and Maintenance 9.3 Replacing Fuses Improper handling may cause electric shock. Do not use any fuse other than the specified rated fuse. Before replacing the fuses, disconnect the power plug from the socket.
1-3
Chapter 1 Safety
1-4
Chapter 2 Composition of PB-10 and System Configuration
Chapter 2
Composition of PB-20 and System Configuration
This chapter describes the composition of the PB-20 set and system configuration.
2.1 Composition of PB-20 .................................................. 2-2 2.2 System Configuration .................................................. 2-3
2-1
Chapter 2 Composition of PB-20 and System Configuration
Chapter 2 Composition of PB-20 and System Configuration 2.1 Composition of PB-20 The PB-20 set consists of the following items. [Note] Figures in parentheses indicate quantities.
Main unit PB-20 (1)
Operation manual (1)
Tube kit TY-04 (1)
2-2
Remote switch RC-20 (1)
Operation manual (Addition Function) (1)
Chapter 2 Composition of PB-10 and System Configuration
2.2 System Configuration The balloon controller is used in combination with the 400 system small intestinal scope and over-tube.
Light source equipment XL-402
Processor VP-402
Multiscan monitor PGM-100P1MD (SONY)
400 system small intestinal scope Data keyboard DK-402E
Balloon BS-1
Over-tube TS-12140 TS-13140
Balloon controller PB-20
Cart PC-20
Remote switch RC-20 Tube kit TY-04
Foot switch FS-1
2-3
Chapter 2 Composition of PB-20 and System Configuration
2-4
Chapter 3 Name and Function of Each Part
Chapter 3
Name and Function of Each Part
This chapter describes the name and function of each part of the PB-20.
3.1 Main Unit (PB-20) ........................................................ 3-2 3.2 Remote Switch (RC-20) ................................................ 3-6 3.3 Tube Kit (TY-04) .......................................................... 3-8 3.4 Foot Switch (FS-1) ....................................................... 3-9
3-1
Chapter 3 Name and Function of Each Part
Chapter 3 Name and Function of Each Part 3.1 Main Unit (PB-20) <Front panel>
1
2
3
4
5 STOP
BALLOON CONTROLLER
DOUBLE BALLOON ENDOSCOPY
PB-20 OVERTUBE OVERTUBE
SCOPE
SCOPE
6 1
8
2
POWER
7
Balloon switch 1 (Over-tube side) When the green lamp is on, press this switch to stop the air supply or discharge. Pressure indicator 1 turns off. When the green lamp is off, press this switch to start the air discharge. Pressure indicator 1 turns on. When the alarm on the over-tube side is sounding, press this switch to stop the alarm. Balloon switch 2 (Endoscope side) When the green lamp is on, press this switch to stop the air supply or discharge. Pressure indicator 2 turns off. When the green lamp is off, press this switch to start the air discharge. Pressure indicator 2 turns on. When the alarm on the Endoscope side is sounding, press this switch to stop the alarm. Pressure indicator 1 (Over-tube side) Indicates the pressure of the balloon connected to the tube connector 1 (Unit: kPa). Indicated color (Negative pressure to 8.1 kPa) : Green 8.2 kPa or more : Red Above 9.3kPa FFF it is indicated.
3-2
Chapter 3 Name and Function of Each Part
Pressure indicator 2 (Endoscope side) Indicates the pressure of the balloon connected to the tube connector 2 (Unit: kPa). The indication method is same as that for the pressure indicator 1. Stop switch While the alarm buzzer is sounding, if you press this switch, the buzzer stops sounding.
Power button Turns the power on and off. When it is switched on, a switch turns on.
Tube connector 2 (Endoscope side) Connect the tube 2 (transparent tube) through the filter of the tube kit.
Tube connector 1 (Over-tube side) Connect the tube 1 (white tube) through the filter of the tube kit.
3-3
Chapter 3 Name and Function of Each Part
<Back panel>
9
10
15
14
13
12
11
Buzzer Sounds an alarm if any abnormality occurs. Press the stop switch once to stop the alarm. Remote terminal The cable of the remote switch is connected to this terminal.
Video output terminal The external monitor to graphically show the balloon conditions is connected to this terminal. “Graphic Display” (page 1-3 of the Manual for Additional Functions) Footswitch terminal Used for connecting the Footswitch.
Power cord
3-4
Chapter 3 Name and Function of Each Part
Fuse holder Used two fuses.
Equipotential terminal The equipotential plug is connected to this terminal.
3-5
Chapter 3 Name and Function of Each Part
3.2 Remote Switch (RC-20)
16
17
18
19
20
1
AIR
PAUSE
2
STOP
26
24
25
23
22
21
Stop switch While the alarm buzzer is sounding, if you press this switch, the buzzer stops sounding.
Pause switch 1 If you press this switch during air feed to or evacuation from the balloon on the over-tube side, the operation at that time is paused. The switch lights up during pausing. [Note] When immediately after the power source ON, line pressure arriving in -6.0KPa, it does not operate. Toggle switch 1 This switch toggles between air feed and evacuation on the over-tube side. If you press this switch once, the switchover valve is switched to the air feed pump and air is fed to the balloon. If the balloon is inflated and the pressure in the channel reaches 5.6 kPa, this pressure is maintained. The switch lights up during air feed. If you press this switch once again, the switchover valve is switched to the evacuating pump side and air is evacuated. This switch is on the evacuation side when the power supply is turned on.
3-6
Chapter 3 Name and Function of Each Part
Balloon evacuation indicator 1 (Over-tube side) When the balloon of over-tube side is evacuation or evacuation pausing, this indicator lights up.
Balloon air feed indicator 1 (Over-tube side) When the balloon of over-tube side is air feed or air feed pausing, this indicator lights up.
Balloon air feed indicator 2 (Endoscope side) When the balloon of Endoscope side is air feed or air feed pausing, this indicator lights up.
Balloon evacuation indicator 2 (Endoscope side) When the balloon of Endoscope side is evacuation or evacuation pausing, this indicator lights up.
Toggle switch 2 This switch toggles between air feed and evacuation on the Endoscope side. If you press this switch once, the switchover valve is switched to the air feed pump and air is fed to the balloon. If the balloon is inflated and the pressure in the channel reaches 5.6 kPa, this pressure is maintained. The switch lights up during air feed. If you press this switch once again, the switchover valve is switched to the evacuating pump side and air is evacuated. This switch is on the evacuation side when the power supply is turned on. Pause switch 2 If you press this switch during air feed to or evacuation from the balloon on the Endoscope side, the operation at that time is paused. The switch lights up during pausing. [Note] When immediately after the power source ON, line pressure arriving in -6.0KPa, it does not operate. RC connector Connects to the remote switch terminal of the main unit.
Index It is index in order to position the revolution of the RC connector. Insert in the remote terminal with this index as on.
3-7
Chapter 3 Name and Function of Each Part
3.3 Tube Kit (TY-04)
27
28
29
30
30
Filter If the balloon is broken, body fluid that flows backwards is stored here.
Tube 2 (Endoscope side) This tube (transparent) is used to connect the main unit and Endoscope.
Tube 1 (Over-tube side) This tube (white) is used to connect the main unit and the over-tube.
Label for tube identification It is the label which identifies tube 1 and tube 2. The tube 1 is used on over tube side. The tube 2 is used on Endoscope side.
3-8
Chapter 3 Name and Function of Each Part
3.4 Foot Switch (FS-1) *Optional Accessory
31
32
33
GraySwitch (Gray) This switch controls the balloon on the over-tube side, which is the same as the function of selector switch 1 on the remote switch. BlackSwitch (Black) This switch controls the balloon on the Endoscope side, which is the same as the function of selector switch 2 on the remote switch. Connector Connects with the footswitch terminal of the main unit.
3-9
Chapter 3 Name and Function of Each Part
3-10
Chapter 4 Preparation and Inspection
Chapter 4
Preparation and Inspection
This chapter describes preparation and inspection of the PB-20.
4.1 Mounting the Filter and Tube ..................................... 4-2 4.1.1 Connecting the Filter and Tube ......................... 4-2 4.2 Installation of PB-20 and Remote Switch ..................... 4-3 4.3 Inspecting the PB-20 ................................................... 4-5 4.3.1 Inspecting the functions of the Pump and the Balloon ................................................. 4-5 4.3.2 Inspecting the Pressure Control Mechanism ..... 4-8 4.4 Installation and Operation of Foot Switch ................. 4-11
4-1
Chapter 4 Preparation and Inspection
Chapter 4 Preparation and Inspection 4.1 Mounting the Filter and Tube
CAUTION It may cause the filter injury. Do not turn the filter forcibly.
Make sure that there is no irregularity such as a flaw or deformation in the appearance of the sterilized filter and tube. [Note] The filter and tube are articles of consumption. Please exchange it once every one months or once every 10 cases. If body fluid flows back to the filter and is trapped there, be sure to replace the complete set of the filter and tube. Be sure to turn off the power switch before disconnecting the filter and tube from the main unit. 4.1.1 Connecting the Filter and Tube (1) Mount a filter on each tube connector. Hold the outer side of the filter and turn clockwise to mount.
(2) Connect the tube to the mounted filter. Tube connector 1 : Tube 1 (White) Tube connector 2 : Tube 2 (Transparence)
4-2
Chapter 4 Preparation and Inspection
4.2 Installation of PB-20 and Remote Switch
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 the protective earth receptacle. It may cause explosion of fire. Do not use the equipment in atmosphere of flammable gas. [Note] Do not use any 3-core/2-core converting plug, because it does not allow reliable protective grounding.
CAUTION The instrument may get overheated. Do not close the vent holes. Falling down or breakage may be caused. Install in a flat place where there is no vibration or shock. Do not put anything on the main unit.
(1) Place the PB-20 mounted with ffilter and tube on a cart and install in the vicinity of the Endoscope system so that the pressure gauge can be observed.
4-3
Chapter 4 Preparation and Inspection
(2) Wrap the remote switch with a waterproof sheet.
(3) Connect the remote switch with the RC connector index on the upper side into the remote terminal and fix it by rotating the outer ring clockwise.
(4) Place the remote switch in a place in which it can be operated easily.
(5) Insert the power cord of the PB-20 into a socket with protective grounding.
4-4
Chapter 4 Preparation and Inspection
4.3 Inspecting the PB-20 4.3.1 Inspecting the functions of the Pump and the Balloon (1) Connect the tube of the PB-20 for the over-tube with the over-tube air inlet.
(2) Turn on the power switch. The power switch lights up and self-diagnosis starts.
If there is no abnormality, the balloon switch lights up and the channel of over-tube side and Endoscope side go into evacuating status. If there is any abnormality, an error message will be displayed on the pressure indicator. “Error Code” (p.10-4)
(3) Press the toggle switch 1 of the remote switch. Make sure that the switch lights up and the balloon of the over-tube inflates.
4-5
Chapter 4 Preparation and Inspection
(4) Press the toggle switch 1 once again. Make sure that the switch goes off and the balloon deflates.
(5) Inflate the balloon again and make sure that there is no air leakage by putting the end of the over-tube into water. After confirmation, press the selector switch 1 to deflate the balloon.
(6) Mount the over-tube to the Endoscope. Mount the balloon to the tip of the Endoscope.
(7) Press the toggle switch of the remote switch 2 in a similar manner. Make sure that the switch lights up and the balloon of the Endoscope inflates.
4-6
Chapter 4 Preparation and Inspection
(8)
Press the toggle switch 2 once again. Make sure that the switch goes off and the balloon deflates.
(9) Inflate the balloon again and make sure that there is no air leakage by putting the end of the Endoscope into water.
<figure of tube connection>
1
2
4-7
Chapter 4 Preparation and Inspection
4.3.2 Inspecting the Pressure Control Mechanism (1) Wear sterilized gloves.
(2) Turn on the power switch. The power switch lights up in green and both the Endoscope side and over-tube side enter into evacuating status.
(3) Make sure that the indications on the pressure indicator 1 and 2 are stable at about -6 kPa.
(4) Wrap the balloon of the over-tube lightly with your hand.
4-8
Chapter 4 Preparation and Inspection
(5) Press the selector switch 1.
(6) Make sure that the balloon inflates and the indication of the pressure indicator is stable at about 5.6 kPa. [Note] The pressure indicator becomes a red display momentarily during air feed. But, it happens by the timing of air feed and pressure display, it is not abnormal.
(7) Press the selector switch 1 once again to deflate the balloon.
(8) Wrap the balloon of the Endoscope lightly with your hand.
4-9
Chapter 4 Preparation and Inspection
(9) Press the selector switch 2.
(10) Make sure that the balloon inflates and the indication of the pressure indicator is stable at about 5.6 kPa. [Note] The pressure indicator becomes a red display momentarily during air feed. But, it happens by the timing of air feed and pressure display, it is not abnormal.
(11) Press the selector switch 2 once again to deflate the balloon.
4-10
Chapter 4 Preparation and Inspection
4.4 Installation and Operation of Foot Switch The balloon can be controlled with the optional foot switch (FS-1) connected to the foot Switch connection terminal.
Connect the connector of the footswitch (FS-1) to the footswitch terminal of the main unit.
GraySwitch (Gray) : This switch toggles between air feed and evacuation on the over-tube side, which is the same as the function of selector switch 1 on the remote switch. BlackSwitch (Black) : This switch toggles between air feed and evacuation on the Endoscope side, which is the same as the function of selector switch 2 on the remote switch.
[Note] Even when the foot switch is connected, the remote switch can be used.
4-11
Chapter 4 Preparation and Inspection
4-12
Chapter 5 How to Use the Equipment
Chapter 5
How to Use the Equipment
This chapter describes the outline of the operation of the equipment according to general procedures. Regarding clinical procedures, use proper clinical judgment.
5.1 Operating Principles .................................................... 5-2 5.2 Operating the Balloon .................................................. 5-4 5.3 If the Alarm Sounds ..................................................... 5-6 5.4 Completion of Inspection ............................................ 5-7
5-1
Chapter 5 How to Use the Equipment
Chapter 5 How to Use the Equipment 5.1 Operating Principles In the PB-20, air feed and evacuation of the balloon are performed by switching between two pumps: the air-feed pump and the evacuating pump. In the PB-20, two balloons, one for the Endoscope and the other for the over-tube, can be controlled independently. <When energized> The system is in evacuating status when energized. Opening/closing solenoid valve Leak valve
Switchover solenoid valve Balloon
Air feed pump Opening/closing solenoid valve Leak valve Evacuating pump
<When inflating the balloon> In the evacuating status when energized, press the toggle switch toggling between air feed and evacuation. The channel is switched to one for the air-feed pump and air feed starts, inflating the balloon. Opening/closing solenoid valve Leak valve
Switchover solenoid valve Balloon
Air feed pump Opening/closing solenoid valve Leak valve Evacuating pump
<In the state in which the balloon has been inflated> If the balloon is inflated and the pressure inside the channel reaches 5.6 kPa, the opening/ closing solenoid valve closes the channel for the air feed pump by a signal from the pressure sensor to maintain the state of inflation of the balloon. Opening/closing solenoid valve Leak valve
Switchover solenoid valve Balloon
Air feed pump Opening/closing solenoid valve Leak valve Evacuating pump
5-2
Chapter 5 How to Use the Equipment
<When deflating the balloon> In the air feeding status in which the balloon is inflated, press the toggle switch toggling between air feed and evacuation. The channel is switched to the one for the evacuation pump and evacuation starts, deflating the balloon. Opening/closing solenoid valve Leak valve
Switchover solenoid valve Balloon
Air feed pump Opening/closing solenoid valve Leak valve Evacuating pump
<In the state in which the balloon has been deflated> If the balloon is deflated and the pressure inside the channel reaches -6.0 kPa, the opening/ closing solenoid valve closes the channel for the evacuating pump by a signal from the pressure sensor to maintain the deflated state of the balloon. Opening/closing solenoid valve Leak valve
Switchover solenoid valve Balloon
Air feed pump Opening/closing solenoid valve Leak valve Evacuating pump
Table 5.1 Each State and Action of Channels and Pumps Channel of Air Feed Pump Side
Channel of
State of
Evacuating Pump Side
Remote Switch Switchover
Pump
Opening/closing solenoid valve
Pump
Opening/closing
solenoid valve
solenoid valve
When energized
Stopped
Closed
In operation
Open / Closed
Evacuating pump
No
Yes
During air feed
In operation
Open / Closed
Stopped
Closed
Air feed pump
Yes
No
In the state in which the balloon is inflated
In operation
Closed
Stopped
Closed
Air feed pump
Yes
No
During evacuating
Stopped
Closed
In operation
Open / Closed
Evacuating pump
No
Yes
In the state in which the balloon is deflated
Stopped
Closed
In operation
Closed
Evacuating pump
No
Yes
Pausing during air feed
In operation
Closed
Stopped
Closed
Air feed pump
Yes
No
Pausing during evacuatin
Stopped
Closed
In operation
Closed
Evacuating pump
No
Yes
Yes:Lights up No :Lights
5-3
Chapter 5 How to Use the Equipment
5.2 Operating the Balloon
CAUTION It may cause a mucous membrane injury. Do not do impossible operation. The operating method for the balloon is common for the Endoscope side and over-tube side. Operations are conducted with individual switches. In this section, operations are described taking the example of operation of the balloon on the Endoscope side. For the method to mount and dismount the balloon, refer to the operation manual for the Endoscope. If any of the following cases occurs, it is judged that a certain irregularity has occurred and the alarm of the PB-20. If the state in which the pressure inside the channel is +8.2 kPa or higher continues for 5 seconds or longer If the pressure does not reach “+5.6 kPa” within 60 seconds after starting air feed If the state in which the pressure inside the channel cannot be maintained at +5.6 kPa continues for 40 seconds or longer If the pressure does not reach “- 6.0 kPa” within 30 seconds after starting evacuation In this case, press the stop switch to stop the alarm and press the toggle switch to conduct evacuation. Then, take appropriate measures in accordance with “5.3 If the Alarm Sounds (Page 5-6).” (1) To inflate the balloon of the Endoscope, press the toggle switch 2 of the remote switch. The switchover valve is actuated to connect the channel to the pump on the air feed side and air is fed to the balloon. The lamp of the switch lights up during air feeding.
(2) If the balloon is inflated and the pressure inside the channel reaches 5.6 kPa, the opening/closing valve is actuated to close the channel and maintains such state. As this operation is conducted automatically by the PB-20, no switch operation is required.
5-4
Chapter 5 How to Use the Equipment
(3) To deflate the balloon, press the toggle switch 2 of the remote switch. The switchover valve is actuated to connect the channel to the pump on the evacuating side and air is evacuated from the balloon. The lamp of the switch is extinguished during evacuation.
(4) If the balloon is deflated and the pressure inside the channel reaches -6.0 kPa, the opening/closing valve is actuated to close the channel and maintains such state. As this operation is conducted automatically by PB-20, no switch operation is required.
(5) In order to pause the state of inflation (or deflation) during air feed or evacuation, press the pause switch of the remote switch. The lamp of the switch lights up during pausing.
(6) To release pausing, press the stop switch once again. [Note] For switching from pausing during air feed to evacuation or from pausing during evacuation to air feed, press the toggle switch.
5-5
Chapter 5 How to Use the Equipment
5.3 If the Alarm Sounds If any of the following conditions occurs, it is considered as an occurrence of an abnormality, which makes the PB-20 alarm sound continuously. Take the following measures depending on the situation. <If the state in which the pressure inside the channel is exceeded +8.2 kPa continues for 5 seconds> Cause : External force has been applied to the balloon. Countermeasure : Press the stop switch to clear the alarm. The equipment automatically reduces the pressure to +5.6 kPa to maintain the pressurized condition. Confirm the safety on the Endoscope or X-ray image, and then restart operation. < If the pressure does not reach “+5.6 kPa” within 60 seconds after starting air feed> Cause : A tube or connector is disconnected. Countermeasure : Press the stop switch to clear the alarm. The equipment automatically maintains air feed condition. Locate the disconnection and reconnect the tube or connector. <If the state in which the pressure inside the channel cannot be maintained at +5.6 kPa continues for 40 seconds or longer> Cause : The balloon is broken. Countermeasure : Remove the endoscopic accessories during processing. Press the stop switch to clear the alarm. Press the toggle switch to discharge air, and then remove and replace the balloon. < If the pressure does not reach “- 6.0 kPa” within 30 seconds after starting evacuation> Cause : A tube or connector is disconnected. Countermeasure : Press the stop switch to clear the alarm. The equipment automatically maintains evacuation condition. Locate the disconnection and reconnect the tube or connector.
[Note] If control with the remote switch becomes inoperative, remove the tube from the air inlet of the Endoscope and over-tube and carry out evacuation manually using the syringe. Then, take out the Endoscope and over-tube while making sure of safety on the monitor screen and stop the inspection. [Note] When the alarm sounds, the toggle switch and the pause switch the side of the alarm sounds do not operate until the alarm is cancelled.
5-6
Chapter 5 How to Use the Equipment
5.4 Completion of Inspection (1) Deflate the balloons of the Endoscope and over-tube by operating the toggle switch or stop switch.
(2) Take out the Endoscope and over-tube.
(3) Turn off the power switch.
(4) Disconnect tubes from the balloon air inlet of the over-tube and Endoscope.
5-7
Chapter 5 How to Use the Equipment
(5) Remove the waterproof sheet used for wrapping the remote switch and dispose of the sheet.
5-8
Chapter 6 Washing
Chapter 6
Washing
This chapter describes methods of cleaning consumables.
6.1 Conditions of Washing ............................................... 6-2 6.2 Necessary Equipment and Materials ........................... 6-3 6.3 Washing ...................................................................... 6-4
6-1
Chapter 6 Washing
Chapter 6 Washing 6.1 Conditions of Washing
CAUTION Improper cleaning may cause damage to the equipment. Perform the cleaning of the equipment by the specified method.
The main unit and the remote switch cannot be disinfected by washing. The washing methods applicable to each part are shown in Table 6.1. Wash the tube with water (tap water) or cleaning fluids. We recommend chemicals listed in Table 6.2 for washing them. We have confirmed that the tube are not degraded by those chemicals. If you want to use chemicals other than those listed here, ask us about the tolerance of the tube. For effects, dilution, and preparation of chemicals under working conditions shown in Table 6.2, refer to manufacturers of respective chemicals. Besides, some chemicals require “precautions in use” or “handling precautions,” such as wearing of gloves, to be observed. Refer also to the instruction manuals of respective chemicals. Table 6.1 Applicable methods of washing for the main unit and expendable supplies Chemical cleaning
Ultrasonic cleaning
Main unit
No
No
Remote switch
No
No
Tube
Yes
Yes
Filter Note
No
No
Yes
No
Tube kit
Balloon Note: Sterilizes the filter with the autoclave.
6-2
Chapter 6 Washing
Table 6.2 Chemicals used for washing and conditions Chemicals
Manufacturer
Trade name
Observe instructions for respective detergent.
Neutral detergent
Enzyme detergent
Dilution ratio
RUHOF CORPORATION
Endozime AW
LABORATORIO S INIBSA
Instrunet EZ
Dilute 8 ml with 1000 ml of cold or warm water. Dilute 120x with warm water.
6.2 Necessary Equipment and Materials Prepare the necessary equipment used in Chapter 6 and Chapter 7.
Sterilized gauze
Syringe
Protective gear Rubber gloves Goggles Mask Protective cloth Chemical solution/ cleaning fluid
Container for chemical solution/cleaning fluid
6-3
Chapter 6 Washing
6.3 Washing (1) Prepare the tube kit and balloon. [Note] Take off the filter of tube kit.
(2) Put the tube and balloon in cleaning fluid.
(3) Wash the surface using gauze in the cleaning fluid.
6-4
Chapter 6 Washing
(4) Using the syringe, inject cleaning fluid into the tube.
(5) Using the syringe, push air into the tube to eject the cleaning fluid inside the tube. (6) Repeat steps (4) and (5) for 2 or 3 times to inject the cleaning fluid and air in turns.
(7) Wash the tube and balloon with running water (tap water).
(8) Wipe off moisture on the tube and balloon with dry gauze.
6-5
Chapter 6 Washing
6-6