FujiFilm PB-30 User manual

PB-30
OPERATION MANUAL
(Ver. 1.0*)
Balloon Controller
Thank you for purchasing our product. Read this manual carefully before use to avoid
unexpected accidents and to take full advantage of the product’s capabilities.
English
フジノン 和 文
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Important Safety Information
2
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 physi-
cian. 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 identied
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
3
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
rst 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 re 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
4
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 Conguration ................................11
2.1 Composition of PB-30..................................................................11
2.2 System Conguration...................................................................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
5
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 Specications....................................................................................................73
Warranty and After-Sales Service .............................................................................79
Disposal of Electric and Electronic Equipment.........................................................80
Index ..........................................................................................................................81
Service Centers ..........................................................................................................82
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Preface
6
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
7
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 Specications” 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 rst. 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
8
5) Electromagnetic interference
This equipment has been tested and found to comply with the limits for medical devices dened
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 rst 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
9
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 specication 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 re.
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 oor.
There is a risk of accidents by electric shock.
Do not take power for the second power strip from the rst 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 ammable gas. Doing so may cause explosion or re.
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
10
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 Conguration
11
Chapter 2 Composition of PB-30 and System Conguration
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)
Operation manual (1)
OPERATION MANUAL
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Chapter 2 Composition of PB-30 and System Conguration
12
2.2 System Conguration
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]
Over-tube [Note 1]
TS-12140
TS-13140
TS-13101
TS-1214B
TS-1314B
TS-1114B
Balloon
BS-2
BS-4
Tube kit
TY-04 (optional accessory)
TY-06 (optional accessory)
TY-400 (optional accessory)
TY-500 (optional accessory)
Remote switch
RC-30
Foot switch
FS1
Balloon controller
PB-30
[Note 1] Accessory 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 congurations 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 congures 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.
Cart [Note 1]
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Chapter 3 Name and Function of Each Part
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Chapter 3 Name and Function of Each Part
3.1 Main Unit (PB-30)
<Front Panel>
1
2
3
8
7
6
45
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
14
4 Tubeconnector2(Endoscopeside)
The tube 2 is connected to this part through the lter of the tube kit.
5 Tubeconnector1(Over-tubeside)
The tube 1 is connected to this part through the lter 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
15
<Back Panel>
1
2
3
4
5
8
7
6
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.
3 Videooutputterminal
An external monitor to graphically show the balloon conditions is connected to this
terminal.
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
16
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
17
3.2 Remote Switch (RC-30)
3.2.1 Name and Function of Each Part of Remote Switch
1
4
5
6
2
3
1 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.
[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
18
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
19
3.2.2 Operation of Remote Swtich
Switch operation Switch state Air supply or discharge
Power-on Inside light: On
Outside light: Off
Air is discharged from the balloon or over-tube.
[Note] When the power is turned on, both the
toggle switches 1 and 2 are set to air
discharge.
When pressed
once
Toggles when
pressed
Inside light: Off
Outside light: On Air is supplied to the balloon or over-tube.
When pressed
once again
Inside light: On
Outside light: Off Air is discharged from the balloon or over-tube.
When the balloon switch on
the main unit is off
Inside light: Off
Outside light: Off
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
20
3.3 Tube Kit [Note] Optional Accessory
[Note] Use the tube kit in combination with the devices in “Main Specications”.
[Note] The lter and tube are consumable supplies. Replace them with new once a month
or once every 10 cases, whichever comes rst.
3.3.1 TY-04 and TY-06
1
2
4
3
4
1
2
3
4
TY-04 [Note] Optional accessory TY-06 [Note] Optional accessory
1 Filter
If the balloon is broken, body uid that ows 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identication
This label identies 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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